FCC ID: PV7-WIBEAR11N-DF2 WLAN/Bluetooth multi-radio host-based module

 

locate, communicate, accelerate ELLA-W1 Antenna trace designs Topic :

ELLA-W1 Antenna trace designs Doc.No:

UBX-16016269 Revision R02 Date:

Created 01-Jul-2016 Checked 01-Jul-2016 Released 06-Jul-2016 Name Stefano Bianconi Igor Shevchenko Daniel Dietterle Signature sbia ishe ddie We reserve all rights in this document and in the information contained therein. Reproduction, use or disclosure to third parties without express authority is strictly forbidden. 2016 u-blox AG 1 Scope This document defines the essential specifications necessary to implement the ELLA-W1 antenna reference designs. The information contained herein and its references should be sufficient to guide a skilled person in an attempt to implement the design on a host carrier. It will provide the designer with PCB layout details and expected performance specifications. The document supports the four different PCB designs:

Two connector-based designs for the use of external antennas (one for each antenna pin of the module) Two designs based on SMD antennas (one for each antenna pin of the module) 2 FCC/IC ID reference Model1 ELLA-W131 ELLA-W133 ELLA-W161 ELLA-W163 FCC ID PV7-WIBEAR11N-SF1 PV7-WIBEAR11N-SF2 PV7-WIBEAR11N-DF1 PV7-WIBEAR11N-DF2 IC ID 7738A-WB11NSF1 7738A-WB11NSF2 7738A-WB11NDF1 7738A-WB11NDF2 Table 1: FCC and IC IDs for different models of ELLA-W1 series 1 The FCC and IC IDs are the same for professional and automotive grade variants of each ELLA-W1 model. ELLA-W1 Antenna trace designs UBX-16016269 Page 1 of 9 locate, communicate, accelerate 3 General description When using the ELLA-W1 together with this antenna reference design, the circuit trace layout must be made in strict compliance with the instructions below. All the components placed on each RF trace must be kept as indicated in the reference design, even if not used. The PCB areas of unused reference designs must be flooded with ground. 1 2 Figure 1: Antenna Reference design embedded in a host carrier PCB Reference Description 1 2 Host carrier PCB (light green) Antenna reference design (dark green) ELLA-W1 Antenna trace designs UBX-16016269 Page 2 of 9 locate, communicate, accelerate 3.1 Floor plan and PCB stack-up This section describes where the critical components are positioned on the reference design. It also presents the stack-up of the four layers of the PCB. 10 3 4 5 6 7 8 9 Figure 2: ELLA-W1 antenna reference design Description SMD antenna Antenna impedance matching network Connectors for external antenna Antenna coplanar microstrip, matched to 50 Top layer GND-plane Antenna impedance matching network SMD antenna ELLA-W1 module Reference 3 4 5 6 7 8 9 10 ELLA-W1 Antenna trace designs UBX-16016269 Page 3 of 9 locate, communicate, accelerate 3.2 PCB stack-up The stack-up used in the reference design is specified in Table 2. PCB Layer Soldermask Top Top Dielectric L2 Dielectric L3 Dielectric Bottom Material Generic LPI Soldermask Copper Foil Pre-preg 2x7628 Copper Foil Core Copper Foil Pre-preg 2x7628 Copper Foil Soldermask Bottom Generic LPI Soldermask Table 2: Stack-up of EVK-ELLA-W1 Thickness 25 m 35 m 360 m 35 m 700 m +/-10%

35 m 360 m 35 m 25 m 3.2.1 RF trace specification The 50 coplanar micro-strip dimensions used in these reference designs are stated in Figure 2 and Table 3. Figure 3: Coplanar micro-strip dimension specification Item S W T H Value 400 m 600 m 35 m 360 m Table 3: Coplanar micro-strip specification ELLA-W1 Antenna trace designs UBX-16016269 Page 4 of 9 locate, communicate, accelerate 3.3 Mechanical dimensions The mechanical dimensions and position of the components are specified in Figure 3. The layers beneath the top layer have the same dimensions and are filled with ground. No RF traces are routed in those layers. Figure 4: Mechanical dimensions of EVK-ELLA-W1, top layer ELLA-W1 Antenna trace designs UBX-16016269 Page 5 of 9 locate, communicate, accelerate 4 Reference designs for antenna pin 1 This section describes the available designs for the antenna pin 1 of the ELLA-W1 modules. Figure 5: Reference schematic for antenna pin 1 4.1 Internal antenna The reference design with internal antenna uses the SMD Antenova type A10194 dual-band antenna that is connected to the module RF-port via a coplanar micro-strip transmission line. 4.1.1 Bill of materials Reference designator Description Manufacturer P/N Antenna CHIP 2.45 & 5 GHz Antenova A10194 IND, Multilayer Ceramic, 10nH, +/-5%, 300mA, SMD 0402 Johanson Technology L-07C10NJV6ST IND, Multilayer Ceramic, 1nH, +/-0.3nH, 300mA, SMD 0402 Johanson Technology L-07C1N0SV6T CAP, CER, 0.2pF, +/-0.1pF, C0G, 50V, SMD 0402 Johanson Technology 500R07S0R2BV4 A1 L1 L2 C2 R1 R2 J7 0 resistor, 0402 Do not Assembly Do Not Assembly 4.1.2 Antenna characteristics Parameter Frequency Range Peak Gain VSWR Efficiency Polarisation Low band 2.4 2.5 1.8

< 1.4:1

>75 Linear Radiation pattern Omnidirectional Temperature range

-40 to +85 Impedance Dimension

(L x W x H) 50 10.0 x 10.0 x 0.9 Generic

-

-

High band 4.9 5.875 4.1

< 1.8:1

>60

-

-

-

Unit GHz dBi

-

%

-

-

C mm ELLA-W1 Antenna trace designs UBX-16016269 Page 6 of 9 4.2 External antenna locate, communicate, accelerate The reference design with external antenna uses the micro coaxial connector that is connected to the external antenna via a 50 pigtail. See section 0 for a list of available external antennas. 4.2.1 Bill of materials Reference designator Description Do Not Assembly Do Not Assembly Do Not Assembly Do Not Assembly Do Not Assembly 0 resistor, 0402 Coaxial Connector, 0 6 GHz, SMD A1 L1 L2 C2 R1 R2 J7 Manufacturer P/N

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Generic Hirose

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U.FL-R-SMT-1(10) ELLA-W1 Antenna trace designs UBX-16016269 Page 7 of 9 locate, communicate, accelerate 5 Reference designs for antenna pin 2 This section describes the available designs for the antenna pin 2 of the ELLA-W1 modules. Note that only ELLA-

W133 and ELLA-W163 use antenna pin 2, for Bluetooth transmission. Figure 6: Reference schematic for antenna pin 2 5.1 Internal antenna The reference design with internal antenna uses the SMD Johanson Technology type 2450AT45A100 antenna that is connected to the module RF-port via a coplanar micro-strip transmission line. 5.1.1 Bill of materials Reference designator Description Manufacturer P/N A2 C3 C4 L3 R9 R10 J8 Antenna CHIP 2.4-2.5GHz Johanson Technology 2450AT45A100 CAP, CER, 2.2pF, +/-0.1pF, C0G, 50V, SMD 0402 Johanson Technology 500R07S2R2BV4 CAP, CER, 1.8pF, +/-0.1pF, C0G, 50V, SMD 0402 Johanson Technology 500R07S1R8BV4 IND, Multilayer Ceramic, 3.9nH, +/-0.3nH, 300mA, SMD 0402 Johanson Technology L-07C3N9SV6T 0 resistor, 0402 Do not Assembly Do Not Assembly Generic

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5.1.2 Antenna characteristics Parameter Frequency Range Peak Gain VSWR Polarisation Low band 2.4 2.5 2.2

< 2:1 Linear Unit GHz dBi

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ELLA-W1 Antenna trace designs UBX-16016269 Page 8 of 9 Parameter Radiation pattern Temperature range Impedance Dimension

(L x W x H) locate, communicate, accelerate Low band Omnidirectional

-40 to +125 50 9.5 x 2.0 x 1.2 Unit

-

C mm 5.2 External antenna The reference design with external antenna uses the micro coaxial connector that is connected to the external antenna via a 50 pigtail. See section 0 for a list of available external antennas. 5.2.1 Bill of materials Reference designator Description Do not Assembly Do Not Assembly Do not Assembly Do not Assembly Do Not Assembly 0 resistor, 0402 Coaxial Connector, 0 6 GHz, SMD A2 C3 C4 L3 R9 R10 J8 Manufacturer P/N

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Generic Hirose

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U.FL-R-SMT-1(10) ELLA-W1 Antenna trace designs UBX-16016269 Page 9 of 9

 

 

IEEE 802.11a/b/g/n WLAN, Bluetooth 3.0+EDR Module WiBear11n Data Sheet Version 1.18 December 2013 The information in this document is subject to change without notice. Please download latest version from www.lesswire.com Copyright 2013 lesswire AG www.lesswire.com WiBear11n Data Sheet Version 1.18 Figure 1: Physical outlook Introduction The WiBear11n industrial universal module is targeted for integration into different OEM products. The module is designed for both simultaneous and independent operation of the following:

IEEE 802.11a/b/g/n payload data rates for Wireless Local Area Network (WLAN), Bluetooth 3.0+High Speed (HS) and Bluetooth 2.1+EDR. It provides a complete end-to-end solution for low-

integrated power applications. MAC/Baseband front-end components and can connect to a host processor through an SDIO interface. includes an and RF processor It The WiBear11n modules are offered in four versions

(see ordering information and block diagram). Host drivers for common operating systems such as Linux and Windows 7 are available. The modules are radio type approved for Europe (CE), US (FCC) and Industry Canada (IC) (pending). Applications

WLAN and Bluetooth networks

Audio/video devices and accessories

Access to laptops, mobile phones etc.

Automotive and industrial networking

Home / building automation Key Features

Standards: IEEE 802.11a/b/g/n/e/i/h/d/k/r/w

WLAN 802.11a/b/g/n station and micro access point operation (up to 8 clients supported)

Support of Wi-Fi direct mode

802.11n 1x1 SISO

802.11 PHY data rates up to 72 Mbps (20 MHz channel) and up to 150 Mbps (40 MHz channel)

Hardware 64- and 128-bit encryption AES engine performance

Embedded security supplicant

WAPI encryption is supported by hardware

Background scan mode

Bluetooth 3.0 + HS (High Speed)

Bluetooth 2.1 + EDR (backward compatibility)

Wide temperature operation range -40C to +85C

Compact 14.8mm x 14.8mm footprint, surface mounting

SDIO high-speed interface

Support for low-power modes

CE/FCC/IC compliant

RoHS compliant

Automotive qualification tests (climatic, mechanical, and operating life tests) according to VW 80000 /

ISO 16750-4 (report pending) Copyright 2013 lesswire AG www.lesswire.com Page 2 of 20 Ordering Information Table 1: Ordering information WiBear11n Data Sheet Version 1.18 Order Number AN00J93170 AN00J93174 AN00J93172 AN00J93176 AN00J94359 AN00J94361 AN00J94360 AN00J94362 AN00J93704 AN00J93705 Model WiBear11n-SF1 WiBear11n-SF2 WiBear11n-DF1 WiBear11n-DF2 WiBear11n-SF1 WiBear11n-SF2 WiBear11n-DF1 WiBear11n-DF2 WiBear11n-DF1_EK WiBear11n-DF2_EK Description WiBear-SF1 Module WiBear-SF2 Module WiBear-DF1 Module WiBear-DF2 Module WiBear-SF1 Module, tape&reel package (500 pcs) WiBear-SF2 Module, tape&reel package (500 pcs) WiBear-DF1 Module, tape&reel package (500 pcs) WiBear-DF2 Module, tape&reel package (500 pcs) Evaluation Kit with WiBear11n-DF1 Module Evaluation Kit with WiBear11n-DF2 Module Note: Shielded modules available on special request. IMDS number: 355902511 Customs Tariff Numbers:

HTC / TARIC:

85177090 ECCN number: 3A001 EORI no.:

DE4665759 Product Variants Table 2: Product variants Model WiBear11n-SF1 WiBear11n-SF2 WiBear11n-DF1 WiBear11n-DF2 Description Single band WLAN (802.11 b/g/n, 2.4 GHz only) and Bluetooth module. Module has one joint antenna connector for WLAN and Bluetooth operation (see block diagram). WiBear11n-SF1/-DF1 is recommended for cost effective AP solution, AP without or rare Bluetooth traffic or cost effective station with one system antenna. Single band WLAN (802.11 b/g/n, 2.5 GHz only) and Bluetooth module. Module has separated antenna connectors for WLAN and Bluetooth operation (see block diagram). Overall performance (throughput) is maximized for AP mode with simultaneous Bluetooth traffic. Two system antennas are required (one for WLAN and one for Bluetooth) with 30 dB or better isolation between antennas (orthogonal oriented antennas with more than 5060 mm. distance between). May be recommended for higher performance of AP. Dual band WLAN (802.11 a/b/g/n, 2.5 and 5 GHz) and Bluetooth module with one joint antenna connector for WLAN and Bluetooth. Similar to WiBear11n-SF1. Dual band WLAN (802.11 a/b/g/n, 2.5 and 5 GHz) and Bluetooth module which has separated antenna connectors for WLAN and Bluetooth. Similar to WiBear11n-SF2. Note: For maximum throughput during simultaneous WLAN (AP) and Bluetooth operation, the Bluetooth Coexistence Arbiter (BCA) settings should be optimized by the host system software. Copyright 2013 lesswire AG www.lesswire.com Page 3 of 20 Block Diagrams WiBear11n-SF1 SDIO GPIOs RESETn PDn SLEEP CLOCK 3.3V 1.8V VIO 802.11b/g/n MAC/BB/RADIO BLUETOOTH 3.0+HS 38.4 MHz Crystal EEPROM WiBear11n Data Sheet Version 1.18 2.4 GHz RF FRONT END 2.5GHz 2.4GHz BPF WLAN &

BT ANT WiBear11n-SF1 Figure 2: Block diagram of WiBear11n-SF1 WiBear11n-SF2 SDIO GPIOs RESETn PDn SLEEP CLOCK 3.3V 1.8V VIO 802.11b/g/n MAC/BB/RADIO BLUETOOTH 3.0+HS 38.4 MHz Crystal EEPROM 2.5GHz WLAN TX 2.5GHz WLAN RX 2.4 GHz RF FRONT END 2.5GHz 2.4GHz BPF WLAN ANT BT TX/RX 2.4GHz BPF BT ANT WiBear11n-SF2 Figure 3: Block diagram of WiBear11n-SF2 Copyright 2013 lesswire AG www.lesswire.com Page 4 of 20 2.5GHz WLAN TX 2.5GHz WLAN/BT RX BT TX WiBear11n Data Sheet Version 1.18 5 GHz RF FRONT END 5GHz 5GHz BPF

&

DIPLEXER WLAN &

BT ANT 2.4 GHz RF FRONT END 2.5GHz 2.4GHz BPF WiBear11n-DF1 5GHz WLAN TX 5GHz WLAN RX 2.5GHz WLAN TX 2.5GHz WLAN/BT RX BT TX 802.11a/b/g/n MAC/BB/RADIO BLUETOOTH 3.0+HS 38.4 MHz Crystal EEPROM Figure 4: Block diagram of WiBear11n-DF1 802.11a/b/g/n MAC/BB/RADIO BLUETOOTH 3.0+HS 38.4 MHz Crystal EEPROM 5GHz WLAN TX 5GHz WLAN RX 2.5GHz WLAN TX 2.5GHz WLAN RX 5 GHz RF FRONT END 5GHz 5GHz BPF

&

DIPLEXER WLAN ANT 2.4 GHz RF FRONT END 2.5GHz 2.4GHz BPF BT TX/RX 2.4GHz BPF BT ANT WiBear11n-DF2 Figure 5: Block diagram of WiBear11n-DF2 WiBear11n-DF1 SDIO GPIOs RESETn PDn SLEEP CLOCK 3.3V 1.8V VIO WiBear11n-DF2 SDIO GPIOs RESETn PDn SLEEP CLOCK 3.3V 1.8V VIO Copyright 2013 lesswire AG www.lesswire.com Page 5 of 20 WiBear11n Data Sheet Version 1.18 Pin Description Table 3: Pin description 0 3 9 2 8 2 7 2 6 2 5 2 D N G 1 T N A D N G D N G 2 T N A D N G 1 2 3 4 5 6 7 8 GND LED_0 LED_1 3V3 VIO 1V8 GND GND PCM_DIN PCM_DOUT PCM_CLK PCM_SYNC CFG SLEEP_CLK GND GND 24 23 22 21 20 19 18 17 0 D _ D S 1 D _ D S n T E S E R 2 D _ D S 3 D _ D S D M C _ D S K L C _ D S n D P 9 0 1 1 1 2 1 3 1 4 1 5 1 6 1 Figure 6: Module pinout Pin Type Pin Name GND LED_0 LED_1 3V3 VIO 1V8 GND GND PDn Pin No. 1 2 3 4 5 6 7 8 9 10 RESETn 11 SD_D2 12 SD_D3 13 SD_CMD 14 SD_CLK 15 SD_D0 16 SD_D1 17 GND 18 GND 19 SLEEP_CLK 20 CFG 21 PCM_SYNC 22 PCM_CLK 23 PCM_DOUT O 24 PCM_DIN 25 GND Ground I/O I/O Power Power Power Ground Ground I I I/O I/O I/O I I/O I/O Ground Ground I I/O I/O I/O I Ground Description Ground LED output (GPIO_1 of Radio/Baseband processor), WLAN activity 1 LED output (GPIO_17 of Radio/Baseband processor), Bluetooth activity 1 3.3V Power supply (3.0V...3.6V) VIO Supply (1.8V or 3.3V) 1.8V Supply (1.7V...1.9V) Ground Ground Full power down (active low), has internal pull-up to VIO pin Reset (active low), has weak internal pull-up to VIO pin SDIO Data line bit [2]

SDIO Data line bit [3]

SDIO Command SDIO Clock input SDIO Data line bit [0]

SDIO Data line bit [1]

Ground Ground Clock input for external sleep clock source (32.768kHz) 2 Configuration pin 3 GPIO_14 of Radio/Baseband processor, output if master, input if slave GPIO_13 of Radio/Baseband processor, output if master, input if slave GPIO_12 of Radio/Baseband processor, output GPIO_11 of Radio/Baseband processor, input Ground Copyright 2013 lesswire AG www.lesswire.com Page 6 of 20 WiBear11n Data Sheet Version 1.18 26 ANT2 I/O, RF 27 GND 28 GND 29 ANT1 Ground Ground I/O, RF Bluetooth antenna for WiBear11n-SF2/-DF2 module, at WiBear-SF1/-DF1 not connected Ground Ground WLAN + Bluetooth antenna for WiBear11n-SF1/-DF1 module, WLAN only antenna for WiBear11n-SF2/-DF2 module Ground Ground 30 GND NOTES: 1 Possible to use as a LED output depend on firmware (driver) version. Regardless of the I/O supply

(1.8V or 3.3V), the supply to the actual board LED always need to use 3.3V on the other end of the LED and works as open drain circuitry in that case. LED current limiting resistor should be used. Maximum sink to the ground current - 10 mA. 2 Should be provided from external source in case of power save operation modes necessity. Not required for full power mode and for automotive use (firmware & driver version 14.44). Mandatory for all other releases with sleep mode support. Sleep clock signal requirements: frequency 32.768kHz 250ppm, low level from 0 to 0.25V, high level from 0.8 to 2.0V, duty cycle 20-80%, slew rate less than 100nS (10-90%). 3 Leave it unconnected when 32.768KHz Sleep Clock provided, pull down by 47K resistor for Sleep Clock less operation. Copyright 2013 lesswire AG www.lesswire.com Page 7 of 20 Electrical Specifications Absolute Maximum Ratings Table 4: Absolute maximum ratings Name 3V3 1V8 VIO Parameter Power supply voltage 3.3V Power supply voltage 1.8V I/O supply voltage 1.8V/2.6/3.3V TSTORAGE Storage temperature Operating Conditions Table 5: Operating conditions Name 3V3 1V8 VIO Parameter Power supply voltage 3.3V Power supply voltage 1.8V I/O supply voltage 1.8V/3.3V TA Ripple Noise Ambient operating temperature Peak-to-peak voltage ripple on 3V3 and 1V8 supply lines. Digital Pad Ratings Table 6: Digital pad ratings Name VIH Input high voltage Parameter VIL Input low voltage VHYS Input hysteresis VOH Output high voltage VOH Output low voltage Note: 1IO voltage, see table above for possible IO voltage range. Current Consumption Table 7: Current consumption RX 2.4GHz 5GHz TX 2.4GHz 5GHz Operation mode

+18dBm

+15dBm

+12dBm

+6dBm

+15dBm

+12dBm

+6dBm WiBear11n Data Sheet Version 1.18 Min

-0.3

-0.3

-0.3

-40 Typ 3.3 1.8 1.8 3.3

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-

Max 3.6 2.0 3.6

+85 Units V V V C Max 3.6 1.89 1.98 3.6

+85 10 Units V V V V C mV Min 3.1 1.74 1.62 3.0

-40

-

Mode1 1.8V 3.3V 1.8V 3.3V 1.8V 3.3V 1.8V 3.3V 1.8V 3.3V Min 0.8*1V8 0.7*3V3

-0.3

-0.3 150 200 1V8-0.4 3V3-0.4

-

-

Max Units 1V8+0.3 3V3+0.3 0.3*1V8 0.3*3V3

-

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0.4 0.4 V V V V mV mV V V V V Current, mA1 1.8V 145 150 140 140 140 140 150 150 150 VIO2 10 10 10 10 10 10 10 10 10 3.3V 0.1 14 200 170 145 120 200 170 150 Notes: 1 Peak values shown, average current for full operation mode (not a power save mode) strongly depend on RX/TX time ratio and remain in range between peak values of RX and TX. 2 VIO current shown for 3.3V I/O voltage. Copyright 2013 lesswire AG www.lesswire.com Page 8 of 20 WiBear11n Data Sheet Version 1.18 Radio Specifications WLAN Module supports dual-band 802.11b/g/n and 802.11a/n operation in both 2.4 GHz and 5 GHz radio bands, respectively. Therefore the module is designed to operate in only one frequency band at time. Table 8: WLAN radio specifications Parameter Operation mode Specification RF Frequency Range Modulation Supported Data Rates Supported Bandwidth Supported Guard Interval Maximum Transmit Power 2.4 GHz 5 GHz Receiver Sensitivity 802.11b/g/n 802.11a/n 802.11b 802.11a/g/n 802.11b 802.11a/g 802.11n 802.11n 802.11n 802.11b 802.11a/g/n 802.11b 802.11g 802.11n 802.11a 802.11n 1 Mbps 11 Mbps 6 Mbps 54 Mbps MCS0 MCS7 MCS0 MCS7 6 Mbps 54 Mbps MCS0 MCS7 MCS0 MCS7 20 MHz 40 MHz 20 MHz 40 MHz 2.400 2.500 GHz 4.900 5.825 GHz CCK and DSSS OFDM 1, 2, 5.5, 11 Mbps 6, 9, 12, 18, 24, 36, 48, 54 Mbps MCS0 - MCS7 20, 40 MHz 400, 800 mS 18 dBm 1 dB 15 dBm 1 dB

-96 dBm 1 dB

-87 dBm 1 dB

-89 dBm 1 dB

-71 dBm 1 dB

-88 dBm 1 dB

-69 dBm 1 dB

-85 dBm 1 dB

-66 dBm 1 dB

-92 dBm 1 dB

-75 dBm 1 dB

-91 dBm 1 dB

-72 dBm 1 dB

-89 dBm 1 dB

-69 dBm 1 dB Table 9: 2.4 GHz Band Supported Channels, 20MHz bandwidth Channel 1 2 3 4 5 Frequency, GHz 2.412 2.417 2.422 2.427 2.432 Channel 6 7 8 9 10 Frequency, GHz 2.437 2.442 2.447 2.452 2.457 Note: 1Channel 14 supported at 802.11b mode only Table 10: 2.4 GHz Band Supported Channels, 40MHz bandwidth Channel 1 2 3 5 6 7 Frequency, GHz 2.422 2.427 2.432 Channel 4 5 6 8 9 10 Frequency, GHz 2.437 2.442 2.447 Channel 11 12 13 141 Frequency, GHz 2.462 2.467 2.472 2.484 Channel 7 11 Frequency, GHz 2.452 Copyright 2013 lesswire AG www.lesswire.com Page 9 of 20 Table 11: 5 GHz Band Supported Channels, 20MHz bandwidth Frequency, GHz 5.180 5.200 5.220 5.240 5.260 5.280 5.300 5.320 Channel 100 104 108 112 116 120 124 128 Frequency, GHz 5.500 5.520 5.540 5.560 5.580 5.600 5.620 5.640 Channel 36 40 44 48 52 56 60 64 Table 12: 5 GHz Band Supported Channels, 40MHz bandwidth Frequency, GHz 5.190 5.230 5.270 5.310 Channel 100 108 116 124 104 112 120 128 Frequency, GHz 5.510 5.550 5.590 5.630 Channel 36 44 52 60 40 48 56 64 Bluetooth WiBear11n Data Sheet Version 1.18 Channel 132 136 140 149 153 157 161 165 Frequency, GHz 5.660 5.680 5.700 5.745 5.765 5.785 5.805 5.825 Channel 132 149 157 136 153 161 Frequency, GHz 5.670 5.755 5.795 Table 13: Bluetooth Radio specifications Parameter Specification RF Frequency Range Supported Modes Number of channels Modulation Transmit Power Receiver Sensitivity 2.400 2.4835 GHz BT 2.1 EDR, BT3.0 HS 79 1 Mbps: GFSK (BDR) 2 Mbps: /4 DQPSK (EDR) 3 Mbps: 8DQPSK (EDR)

+8 dBm 1.5 dB BDR: -90 dBm 1.5 dB EDR: -87 dBm 1.5 dB Copyright 2013 lesswire AG www.lesswire.com Page 10 of 20 WiBear11n Data Sheet Version 1.18 Physical Dimensions Figure 7: Physical dimensions 1 3 2 29 28 27 25 26 24 30 Note: The tolerances +/- 0.1 mm may be exceeded in the corners of the PCB due to the cutting process. In worst case, the outer dimensions could reach 15.1 mm. Recommended Footprint Pitch=1.27 14.8 8

. 4 1 1.6 0.6 23 22 21 10 14 15 16 11 12 13 20 19 18 17 4 9 5 6 7 8 0 8

. Copyright 2013 lesswire AG www.lesswire.com Page 11 of 20 Figure 8: Recommended footprint WiBear11n Data Sheet Version 1.18 Host Interfaces SDIO Interface WiBear11n module supports a SDIO device interface that conforms to the industry standard SDIO Full-Speed specification and allows a host controller using the SDIO bus protocol to access the WLAN and Bluetooth functions. The module also supports High Speed mode as defined in the SDIO 1.2 specification. The module's SDIO host interface pins are powered from the VIO voltage supply. A module acts as the device on the SDIO bus. The SDIO interface supports SDIO modes at the full clock range of 0 to 50 MHz which allows a maximum throughput of 200Mbps. fPP TWL Clock Input Output Clock Input Output TWH TIH TODLY Figure 9: SDIO Protocol Timing Diagram TWL TODLY fPP TWH TIH TOH TISU TISU Figure 10: SDIO Protocol Timing Diagram at High Speed Mode Copyright 2013 lesswire AG www.lesswire.com Page 12 of 20 Table 14: SDIO Host Interface Timing Data WiBear11n Data Sheet Version 1.18 Parameter Condition Min Typ Symbol fPP TWL TWH TISU TIH Clock Frequency Clock Low Time Clock High Time Input Setup Time Input Hold Time TODLY Output Delay Time TOH Output Hold Time Normal High Speed Normal High Speed Normal High Speed Normal High Speed Normal High Speed Normal High Speed High Speed 0 0 10 7 10 7 5 6 5 2

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2.5

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Max 25 50

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-

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14 14

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Units MHz MHz ns ns ns ns ns ns ns ns ns ns ns Copyright 2013 lesswire AG www.lesswire.com Page 13 of 20 WiBear11n Data Sheet Version 1.18 Figure 11: Evaluation Kit outlook Reference Design Overview Reference design shows how to connect a WiBear11n module to the host controller. WLAN and Bluetooth

(BT3.0 HS + EDR) may be connected to the host simultaneously over the SDIO bus. The layout is equipped with the possibility to either use an onboard antenna or an external antenna connected via coaxial connector by means of setting of jumper R7 or R8. Host interface voltage can also be changed by jumper J6. The ready-

made reference design is available as WiBear11n Evaluation Kit from Lesswire AG. Schematic Diagram Figure 12: Evaluation kit schematic diagram Antenna matching components (L1, C7, L2) values depend on antenna type, layout, PCB material and PCB thickness WLAN and Bluetooth at the different antenna terminals

(U1:Pin 29 and U1:Pin 26 correspondingly) for uAP functionality WiBear11n-DF1 WiBear11n-SF1 WiBear11n-DF2 WiBear11n-SF2 DAT2 DAT3 CMD GND VDD CLK GND DAT0 DAT1 RESET SD_D2 SD_D3 CMD CLK SD_D0 SD_D1 SD_D2 SD_D3 SD_CMD SD_CLK SD_D0 SD_D1 WLAN and Bluetooth at the same antenna terminal (U1:Pin 44) PCM_SYNC PCM_CLK PCM_DOUT PCM_DIN GND GND GND GND GND GND GND GND GND SD_D2 SD_D3 CMD CLK SD_D0 SD_D1 32.768kHz 10mS Start Up Time C4 100nF 3V3 VIO A1 Dual Band Antenna SD_D2 SD_D3 CMD 1 7 8 17 18 25 27 28 30 SLP_CLK CFG SLP_CLK CFG 1 3 5 7 9 11 13 2 4 6 8 10 12 14 Assembly Option MCP1824T-1802E Orange

"WLAN"

11 12 13 14 15 16 SD_D0 SD_D1 Green

"Supply"

20mS Reset Pulse PD RESET LED_0 LED_1 LED_0 LED_1 3V3 VIO 1V8 9 1 2 3 4 5 6 7 8 C1 100nF TPS3808G30 C6 100nF 21 22 23 24 L1 6.8nH WiBear11n SLP_CLK C7 2.2pF C2 10uF Description L2 12nH C3 10uF Blue

"BT"

J2 MAIN R8 DNP C5 DNP 3 J6 J3 AUX RESET RESET R3 3.6k R6 47K R5 10K R4 10K LED_1 LED_0 R1 360 R2 620 RESET SENSE SDIO SDIO R7 0 CFG ANT2 ANT1 9 10 19 20 CLK DNP GND GND VDD GND VCC 4 5 6 OUT OUT VIO 3V3 1V8 3V3 3V3 3V3 3V3 1V8 3V3 1V8 3V3 MR EN EN NC CT U1 U1 D1 D2 U3 U2 D3 J7 J8 J4 2 3 J5 Y1 IN 26 29 J1 J3

+

1 2 1 2 1 2 3 1 3 2 4 5 6 1 2 3 4 1 3 2 4 5 Copyright 2013 lesswire AG www.lesswire.com Page 14 of 20 Assembly diagram Bill of Materials Table 15: Bill of materials Figure 13: Evaluation kit assembly diagram Qty Designator Part Description Antenna CHIP 2.45 & 5 GHz, 10.4x10.4x0.8mm 1 A1 3 C1, C4, C6 CAP, CER, 100nF, 10%, X7R, 16V, SMD 0402 2 C2, C3 CAP, CER, 10uF, 20%, X5R, 6.3V, SMD 0603 DNP 1 C5 CAP, CER, 2.2pF, +/-0.25pF, C0G, 50V, SMD 0402 1 C7 LED, Green, SMD 0603 1 D1 1 D2 LED, Orange, SMD 0603 LED, Blue, SMD 0603 1 D3 Pin Header, Double Row, 2.54mm pitch, Straight, 2x7 Way, Through Hole Coaxial Connector, 0 - 6GHz, SMD Pin Header, Pitch 2.0mm, 1x3 Way, Through Hole Pin Header, Pitch 2.0mm, 1x2 Way, Through Hole IND, Multilayer Ceramic, 6.8nH, +/-5%, 300mA, SMD 0402 IND, Multilayer Ceramic, 12nH, +/-5%, 300mA, SMD 0402 1 J1 2 J2, J3 2 J4, J6 3 J5, J7, J8 1 L1 1 L2 WiBear11n Data Sheet Version 1.18 Manufacturer Part Number Antenova: A10194 Generic Components Generic Components Generic Components Generic Components Avago: HSMG-C190 Avago: HSMD-C190 Avago: HSMR-C190 Generic Components Hirose: U.FL-R-SMT Samtec: TMM-103-01-G-S Samtec: TMM-102-01-G-S Generic Components Generic Components Lesswire AG:

WiBear11n_EK_R1 Generic Components Generic Components Generic Components Generic Components Generic Components Generic Components 1 PCB 1 R1 1 R2 1 R3 2 R4, R5 1 R6 2 R7, R8 1 U1 1 U2 1 U3 1 Y1 PCB, Dual side, 82x24x1.5mm, Rev.1A RES, 360 Ohm, 5%, 1/16W, SMD 0402 RES, 620 Ohm, 5%, 1/16W, SMD 0402 RES, 3.6k, 5%, 1/16W, SMD 0402 RES, 10k, 5%, 1/16W, SMD 0402 RES, 47K, 5%, 1/16W, SMD 0402 RES, 0 Ohm, 1/16W, SMD 0402 WLAN 802.11a/b/g/n and Bluetooth Module, 14.8x14.8x2.5mm Lesswire AG: WiBear11n CMOS LDO Voltage Regulator 1.8V 300mA, SOT23-5 Voltage supervisor, programmable reset time, threshold voltage 2.79V, SOT23-6 Quartz Oscillator, 32.768kHz, 1.8V, +/-50ppm, -40...+85C, SMD 3.2x2.5x1.0mm Microchip: MCP1824T-

1802E/OT Texas Instruments:

TPS3808G30 Pericom: KK3270049 Copyright 2013 lesswire AG www.lesswire.com Page 15 of 20 WiBear11n Data Sheet Version 1.18 Mounting process The WiBear11n is a surface mount module supplied on a 6-layer FR4-type PCB with gold plated connection pads and produced in a lead-free process with a lead-free soldering paste. The warpage of the PCB is max. 0,75% according to IPC-A-610E. The thickness of solder resist on the host PCB top side and the WiBear11n bottom side must be considered for the soldering process. Modules rated at moisture sensitivity level 3. See moisture sensitive warning label on each shipping bag for detailed information. After opening the dry pack, modules must be mounted within 168 hours in factory conditions of maximum 30C/60%RH or must be stored at less than 10%RH. Modules require baking if the humidity indicator card shows more than 10% when read at 235C or if the conditions mentioned above are not met. Please refer to J-STD-033B standard for bake procedure. Module is compatible with industrial reflow profile for RoHS/Pb-free solders, Sn96.5/Ag3.0/Cu0.5 solder is a right choice. Use of "No Clean" soldering paste is strongly recommended, cleaning the populated modules is strongly discouraged - residuals under the module cannot be easily removed with any cleaning process. Cleaning with water can lead to capillary effects where water is absorbed into the gap between the host board and module. The combination of soldering flux residuals and encapsulated water could lead to short circuits between neighboring pads. Only a single reflow soldering process is permitted for host boards with WiBear11n modules. The reflow profile used is dependent on the thermal mass of the entire populated PCB, heat transfer efficiency of the oven and particular type of solder paste used. Since the profile used is process and layout dependent, the optimum profile should be studied case by case. Recommendations below should be taken as a starting point guide. In case of basic information necessity please refer to J-STD-020C standard. Table 16: Recommended reflow profile Profile feature Ramp up rate (TSMAX to TP) Minimum soak temperature (TSMIN) Maximum soak temperature (TSMAX) Soak time (ts) Liquidus temperature (TL) Time above TL (tL) Peak temperature (TP) Time within +0 / -5C of actual TP (tp) Ramp down rate Time from 25C to TP Sn-Pb eutectic

(Sn63/Pb37) RoHS/Pb-free

(Sn96.5/Ag3.0/Cu0.5) 3C/sec max 100C 150C 60 - 120 sec 183C 60 - 150 sec 215 - 225C 10 - 30 sec 6C/sec max 6 min max 3C/sec max 150C 200C 60 - 180 sec 217C 60 - 150 sec 235 - 245C 20 - 40 sec 6C/sec max 8 min max Note: lowest value of TP and slower ramp down rate (2 - 3C/sec) is preferred. Copyright 2013 lesswire AG www.lesswire.com Page 16 of 20 Figure 14: Reflow profile Installation and Regulatory Information General WiBear11n Data Sheet Version 1.18 The purpose of this guide is to explain how to integrate the WiBear11n module into the end product. The module has to be installed and used in accordance with the technical instructions provided by the manufacturer. The module may only be implemented in the configuration that was authorized. Note that any modifications of this equipment not expressly approved by the manufacturer could void the users authority to operate the equipment. European Union Regulatory Compliance The WiBear11n module has been tested and complies with the regulatory standards EN 300 328 and EN 301 489-1/-17. We declare that the human exposure of this module is below the SAR limits specified in the EU recommendations 1999/519/EC. IMPORTANT: The CE marking must be affixed to a visible location on the OEM product, where this module is installed in, and has to be labeled in accordance to R&TTE Directive 1999/5/EC. FCC Compliance This device complies with Part 15 of the FCC Rules1. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. Not authorized modification could void authority to use this equipment. The internal / external antenna(s) used for this module must provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE: The outside of final product that contain a WiBear11n module must display in a user accessible area a label referring to the enclosed module. This exterior label can use wording such as the following: Contains Transmitter Module FCC ID: PV7-WIBEAR11N-SF12 or Contains FCC ID: PV7-WIBEAR11N-SF1. IMPORTANT: The approval type for the WiBear11n variants is a limited modular approval due to the absence of a shielding. This requires any manufacturer of original equipment containing the WiBear11n module to ask for an approval of their design by the manufacturer of the WiBear11n module. IC Compliance This device complies with Industry Canada RSS-210 (Rev. 8). Operation is subject to the following two conditions:

(1) this device may not cause interference, and

(2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes:

(1) l'appareil ne doit pas produire de brouillage, et

(2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada. Not authorized modification could void authority to use this equipment. 1 Limited modular approval has been applied for the module variant WiBear11n-SF1, the certification process for the other module variants is ongoing. 2 FCC and IC IDs for the WiBear11n module variants are shown in Table 19. Select the applicable ID. Copyright 2013 lesswire AG www.lesswire.com Page 17 of 20 WiBear11n Data Sheet Version 1.18 The internal / external antenna(s) used for this module must provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE: The outside of final product that contain a WiBear11n module must display in a user accessible area a label referring to the enclosed module. This exterior label can use wording such as the following: Contains Transmitter Module IC ID: 7738A-WB11NSF12 or Contains IC ID: 7738A-WB11NSF1. IMPORTANT: The approval type for the WiBear11n variants is a limited modular approval due to the absence of a shielding. Due to Industry Canada Modular Approval Requirements (Source: RSS-Gen / Issue 3 / Dec. 2010) any application which includes the WiBear11n module must be approved by the module manufacturer

(lesswire AG). The application manufacturer must provide design data for the review procedure. Approved Antennas List For Bluetooth and WLAN operation in the 2.4 GHz band, the module has been tested and approved for use with the antenna listed in the table below. Table 17: Approved antennas list, single-band operation Model Name Manufacturer and description Gain [dBi]

2450AT45A100 Johanson Technology, Chip antenna, 2400 2500 MHz 3.0 (peak) For Bluetooth, WLAN operation in the 2.4 GHz band, and WLAN operation in the 5 GHz band, the module has been tested and approved for use with the antenna listed in the table below. Table 18: Approved antennas list, dual-band operation Model Name Manufacturer and description A10194 Antenova, dual-band SMD antenna, 2.4 2.5 GHz and 4.9 5.9 GHz Gain [dBi]

1.8 (peak) The module may be integrated with other antennas which the OEM installer must authorize with respective regulatory agencies and after approval of the module manufacturer. FCC and IC IDs Table 19: FCC and IC IDs for WiBear11n module variants Model Model number FCC ID IC ID WiBear11n-SF1 AN00J93170 PV7-WIBEAR11N-SF1 7738A-WB11NSF1 WiBear11n-SF2 AN00J93174 PV7-WIBEAR11N-SF2 7738A-WB11NSF2 WiBear11n-DF1 AN00J93172 PV7-WIBEAR11N-DF1 7738A-WB11NDF1 WiBear11n-DF2 AN00J93176 PV7-WIBEAR11N-DF2 7738A-WB11NDF2 Label Due to the small module size, the FCC and IC IDs cannot be displayed on the label. The corresponding FCC and IC IDs for the module variants are shown in the table above. Copyright 2013 lesswire AG www.lesswire.com Page 18 of 20 Label drawing:

Label location:

WiBear11n Data Sheet Version 1.18 Figure 15: Label and label location Copyright 2013 lesswire AG www.lesswire.com Page 19 of 20 Revision History Table 20: Revision history WiBear11n Data Sheet Version 1.18 Date Version Author Description 20-Jun-2012 1.00 Igor Shevchenko Preliminary release 22-Jun-2012 1.01 Andras Varadi Andreas Beierer Igor Shevchenko Some minor mistakes fixed 16-Jul-2012 1.02 Igor Shevchenko PCM interface description added, Supported channels presented in region independent form. 01-Oct-2012 1.03 Igor Shevchenko Minor mistakes fixed, Evaluation Kit information added 05-Dec-2012 1.04 Daniel Dietterle Updated order codes for latest hardware revision C 11-Jan-2013 1.05 Daniel Dietterle Added installation and regulatory information 16-Jan-2013 1.06 Daniel Dietterle Added label information and table with FCC/IC IDs 18-Jan-2013 1.07 Igor Shevchenko Added Wi-Fi Direct mode support 18-Jan-2013 1.08 Igor Shevchenko Requirements (Note 2) for Sleep Mode updated 22-Jan-2013 1.09 Daniel Dietterle Added paragraph on IC compliance 06-Feb-2013 1.10 Daniel Dietterle Added paragraph on IC compliance in French language 22-Feb-2013 1.11 Igor Shevchenko Dimension drawing improved (tolerances added) 25-Feb-2013 1.12 Daniel Dietterle FCC ID's and IC ID's with cross-reference to model numbers 28-Mar-2013 1.13 Daniel Dietterle Added: RoHS compliance; mounting process (warpage);

custom tariff numbers; IMDS number 07-May-2013 1.14 Daniel Dietterle Electrical specification updated: minimum supply voltage and ripple noise, digital pad ratings corrected Physical dimensions: Contour tolerances in corners of the PCB added 14-May-2013 1.15 Daniel Dietterle Added order information for tape&reel packing 15-May-2013 1.16 Daniel Dietterle Corrected ordering information for variants DF1 and SF2 (T&R) 21-May-2013 1.17 Daniel Dietterle Release, no changes. 19-Dec-2013 1.18 Daniel Dietterle Approved antenna list extended Copyright 2013 lesswire AG www.lesswire.com Page 20 of 20

 

 

Tempus Pro User/Operator Manual Part number 41-2001EN-00 Date of issue: 2019-07-03 This document contains legally protected information. All rights reserved. Copying in mechanical, electronic and any other form without the written approval of the manufacturer is prohibited. Copyright 2013-2019 Remote Diagnostic Technologies Ltd. Manufacturers address RDT contact details The Tempus Pro is designed and manufactured by:

Remote Diagnostic Technologies Limited Pavilion C2 Ashwood Park Ashwood Way Basingstoke Hampshire RG23 8BG UK Tel: +44 (0) 1256 362 400 Fax: +44 (0) 1256 362 415 www.rdtltd.com Australian TGA sponsor:

Philips Electronics Australia Ltd 65 Epping Road North Ryde NSW Australia 2113 0413 Tempus Pro User/Operator Manual - 41-2001EN-00 Table of Contents 1 Introduction 1.1 CE statement FDA prescription statement 1.2 1.3 Proprietary notice 1.4 Use of this manual 1.5 1.6 1.7 Intended users Features list Patent and warranty 1.7.1 Patent claims 1.7.2 1.7.3 Service support and returns Limited warranty 2 Warnings and cautions 2.1 2.2 2.3 Safety and note icons EMC information Indications for use 2.3.1 Contraindications 2.4 General warnings, cautions and notes 3 Introduction to the Tempus Pro 3.1 Overview of the Tempus Pro 3.2 Key features of the unit 3.2.1 Tempus Pro front 3.2.2 Tempus Pro base 3.2.3 Tempus Pro rear 3.2.4 Tempus Pro left side 3.2.5 Tempus Pro right side Theory of operation 3.3 Invasive pressure 3.3.1 Pulse rate and oxygen saturation (SpO2) 3.3.2 Non-invasive blood pressure 3.3.3 Electrocardiograph (ECG) 3.3.4 Impedance pneumography 3.3.5 End tidal CO2 (ETCO2) and respiration rate 3.3.6 Temperature 3.3.7 3.3.8 Controls and indicators 3.3.9 Summary Record of Care / Tactical Combat Casualty Care 3.3.10 3.3.11 3.3.12 3.3.13 3.3.14 3.3.15 3.3.16 Previous activity button Trends Data handover Email ePCR export Communications On-screen user instructions 9 10 10 10 11 11 11 12 12 12 12 13 13 13 14 14 15 25 26 26 26 26 27 28 29 31 31 32 32 32 32 33 33 33 34 34 34 34 34 34 35 36 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 3 Table of Contents 4 Setting up Starting and stopping the Tempus Pro and selecting a patient Before deployment 4.1 4.2 Unpacking the Tempus Pro 4.3 4.3.1 Switching on 4.3.2 Tactical mode (optional) 4.3.3 Setting the patient 4.3.4 Starting and stopping iAssist 4.3.5 Switching off 5 Using the Tempus Pro 5.1 Controlling the Tempus Pro 5.1.1 The touchscreen 5.1.2 Membrane buttons and LED indicators 5.1.3 Status bar 5.1.4 Status bar for communications 5.1.5 Instrument readings 5.2 Menus 5.2.1 The main menu 5.2.2 Printer and Headset menu 5.2.3 Power and clock settings 6 Taking medical readings 6.1 Electrocardiography (ECG) 6.1.1 Getting started 6.1.2 Monitoring ECG with a 3-lead cable 6.1.3 Monitoring ECG with a 4-lead cable 6.1.4 Monitoring ECG with a 5-lead cable 6.1.5 Monitoring ECG with a 12-lead cable 6.1.6 Performing a diagnostic ECG 6.1.7 ECG specifications 6.1.8 ECG settings 6.1.9 Detecting arrhythmias during ECG monitoring 6.1.10 6.1.11 6.1.12 Measuring ST elevation and QT interval (optional) Monitoring respiration rate with ECG cable Monitoring heart/pulse rate with no leads 6.2 Non-invasive blood pressure (NIBP) 6.3 6.2.1 Getting started 6.2.2 Taking readings 6.2.3 NIBP settings Pulse oximetry 6.3.1 Getting started 6.3.2 Pleth variability index 6.3.3 Taking readings 6.3.4 Features 6.3.5 Pulse oximetry probes 6.3.6 Pulse oximeter settings 6.3.7 SpHb settings 6.4 Capnography 6.4.1 Getting started 6.4.2 Taking readings 6.4.3 Capnometer settings 6.5 Contact temperature 6.5.1 Getting started 6.5.2 Taking readings 6.5.3 Contact temperature settings Tempus Pro User/Operator Manual - 41-2001EN-00 Page 4 37 37 38 39 39 39 41 41 42 43 43 43 45 46 48 49 50 50 53 53 55 55 57 58 59 60 61 63 66 68 70 72 74 77 78 81 81 83 85 95 95 96 97 98 99 102 103 105 106 107 109 109 109 110 6.6 Invasive pressure 6.6.1 Getting started 6.6.2 Taking readings 6.6.3 6.6.4 Configuring the transducer / channel 6.6.5 Zeroing transducers 6.6.6 Two channel USB invasive pressure module Invasive pressure settings 7 Alarms 7.1 7.2 Audible alarm characteristics Visual alarm characteristics 7.2.1 Alarm bar LEDs 7.2.2 Alarm status area 7.2.3 Alarm limits bar 7.2.4 Bottom status bar Patient alarms Technical alarms Setting alarms 7.5.1 Default alarm settings 7.5.2 All alarms menu 7.3 7.4 7.5 7.6 7.7 7.8 7.9 Silencing or suspending alarms Viewing and clearing alarms Tactical mode warning Testing alarms 8 Summary Record of Care 8.1 Event capture 8.1.1 General screen 8.1.2 Assessment, intervention, fluid and drug screens 8.1.3 Map/score screen 8.1.4 Automatic event capture 8.2 Events summary list 8.2.1 Summary screen 8.2.2 Waveform viewer 8.2.3 Updating an observation category marker 8.3 Trends 8.3.1 Trend graph 8.3.2 Trend table 9 Other features of the Tempus Pro 9.1 Data input and output 9.1.1 The Data Input and Output menu 9.1.2 Send patient data/report 9.1.3 Tempus to Tempus data handover 9.2 Display options 9.2.1 The Display menu 9.2.2 Display modes 9.2.3 High contrast mode 9.2.4 Waveform and lead selection 9.2.5 Brightness control 9.2.6 9.2.7 Power save feature Patient information Locking the touchscreen 9.3.1 The patient menu 9.3.2 Updating the TCCC card 9.3 Table of Contents 112 113 113 115 115 117 119 123 125 125 126 126 127 128 129 132 135 135 137 141 143 144 145 147 147 147 148 151 153 154 155 155 156 156 156 157 159 159 159 160 165 166 166 168 169 170 172 173 174 174 174 175 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 5 Table of Contents 9.3.3 Admitting a new patient 9.3.4 Switching to a previous patient 9.3.5 Entering patient details 9.4 Digital camera 9.4.1 Annotation of digital pictures 9.5 GPS location 9.6 Connecting to an alternate location 9.6.1 Making the data connection 9.6.2 Fitting the headset and making the voice connection 9.6.3 Connection status indicators 9.6.4 Communications modes 9.6.5 9.6.6 Recording data off-line and transmitting on-line Interacting with the Response Centre 9.7 iAssist processes 9.7.1 Monitoring ECG 9.7.2 Taking blood pressure measurements 9.7.3 Taking pulse oximetry measurements 9.7.4 Taking capnometry readings 9.7.5 Taking temperature readings 9.7.6 Using the camera 9.8 9.9 View installed features Printer maintenance 9.9.1 External printer configuration 9.9.2 9.9.3 Changing the paper roll (internal printer only) 9.9.4 Fitting the printer lid (internal printer only) Internal printer configuration (optional) 9.10 Managing Wi-Fi networks 10 After using the Tempus Pro Inspecting the Tempus Pro 10.1 10.2 Cleaning the Tempus Pro Cleaning the case of the Tempus Pro Cleaning the display Cleaning connectors Cleaning the NIBP cuffs and hose Cleaning the SpO2, ECG and invasive pressure cables Cleaning the battery contacts 10.3 Disposal at end of life Disposal of single use devices 11 Maintenance, servicing and troubleshooting 11.1 Tempus Pro battery The battery Removing the battery from the Tempus Pro Charging the battery 11.2 Wireless headset battery Charging the headset General guidelines for safe use Disposal of batteries 11.3 Daily checks 11.4 Weekly checks 11.5 Troubleshooting 12 Accessories list of the Tempus Pro 12.1 Parts list Tempus Pro User/Operator Manual - 41-2001EN-00 Page 6 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5 10.2.6 10.3.1 11.1.1 11.1.2 11.1.3 11.2.1 11.2.2 11.2.3 179 181 182 183 184 185 186 187 188 191 192 194 195 195 197 197 197 197 197 197 198 198 198 198 199 202 204 207 207 207 207 208 209 209 209 209 209 210 211 212 212 214 215 218 218 219 219 219 220 220 221 221 Temperature accessories Invasive pressure accessories Non-invasive blood pressure accessories Masimo accessories Masimo Rainbow field upgrades Ultrasound accessories Video laryngoscope accessories Capnometer accessories Electrocardiogram accessories 12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6 12.1.7 12.1.8 12.1.9 12.1.10 Power and charging accessories 12.1.11 12.1.12 Miscellaneous accessories 12.1.13 Anaesthetic gas monitoring accessories 12.1.14 Corsium Crew accessories 12.1.15 Manuals and software accessories Tempus Pro ReachBak real-time telemedicine accessories 13 Configuring the Tempus Pro 13.1 Demonstration and training 14 Specifications and standards 14.1 Specifications 14.2 Physical characteristics and environmental specifications ECG monitoring 12-lead diagnostic ECG viewing and recording Impedance pneumography (respiration) ETCO2 sensor Non-invasive blood pressure Invasive pressure Masimo pulse oximetry Masimo Set rainbow Contact temperature 14.1.1 14.1.2 14.1.3 14.1.4 14.1.5 14.1.6 14.1.7 14.1.8 14.1.9 14.2.1 14.2.2 Environmental performance and certification Use in high ambient temperatures 14.3 Miscellaneous features and specifications 14.3.1 14.3.2 14.3.3 14.3.4 14.3.5 14.3.6 14.3.7 Invasive pressure USB module 01-2017 (optional) Rechargeable battery Mains power supply Battery charger Vehicle power supply GPS Other features 14.4 Communications i2i ReachBak communications Ethernet specification 14.4.1 14.4.2 14.4.3 WiFi specification 14.4.4 14.4.5 14.4.6 14.4.7 14.4.8 Integral 2G and 3G cell phone specification Bluetooth specification Bluetooth headset specification Communications security specification FCC and Industry Canada compliance 14.5 Tempus Pro device classification Standards compliance 14.6 EMC information Cable length of the sensors and the accessories Manufacturer's Declarations Recommended safety distances 14.5.1 14.6.1 14.6.2 14.6.3 14.7 Factory default settings Table of Contents 221 221 222 222 223 223 224 224 224 226 226 226 227 227 227 229 229 231 231 231 232 233 234 234 235 235 237 238 239 240 242 243 243 244 245 245 246 246 246 247 247 248 248 249 250 250 250 251 252 252 253 253 254 258 258 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 7 Table of Contents 15 Symbols used on the Tempus Pro 15.1 Symbols used 16 End user license agreement 16.1 Tempus Pro EULA 16.2 Mocana EULA 16.3 MPEG4 EULA 16.4 Masimo EULA 16.5 Firebird Interbase Public License 16.6 16.7 OpenSSL License 16.8 US Government Devices US Department of Defense (DoD) Notice and Consent Banner Info-Zip License 260 260 268 268 269 270 270 271 271 271 272 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 8 1 Introduction This manual is for the Tempus Pro patient monitor. All Tempus Pro monitors have a standard configuration that provides ECG monitoring, NIBP, pulse oximetry

(SpO2) and impedance respiration. Additional functions are available depending on Tempus Pro part number:

00-1004-R: standard configuration with invasive pressure (2 channels), ETCO2 and contact temperature

(1 or 2 channels). 00-1007-R: standard configuration with invasive pressure (2 channels), ETCO2, contact temperature (1 or 2 channels) and Bluetooth headset. 00-1024-R: standard configuration with printer, ETCO2 and contact temperature (1 or 2 channels). 00-1026-R: standard configuration with printer, invasive pressure (2 channels), ETCO2 and contact temperature (1 or 2 channels). For a full list of Tempus Pro features, see 1.6 Features list. Note Tempus Pro pulse oximetry provides the standard SpO2, pulse rate and perfusion index (PI) measurements but also has the capability to monitor carboxyhaemoglobin saturation

(SpCO), methaemoglobin saturation (SpMet), total haemoglobin concentration (SpHb), total oxygen content (SpOC) and pleth variability index (PVI). The Tempus Pro is supplied in different configurations depending on the customers requirements. This manual is written to cover all Tempus Pro features and therefore details regarding optional features will not be applicable to all units. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 9 Chapter 1 Introduction 1.1 CE statement Marking by the above symbol indicates compliance of this device to the Medical Devices Directive (MDD) 93/42/EEC (as amended) and the Radio Equipment Directive (RED) 2014/53/EU (as amended). The CE mark is accompanied by the number 0413 which is the reference number for the Notified Body who certify RDTs quality system. The Tempus Pro is a class IIb device under the MDD and is a class I device (harmonised frequencies) under the Radio Equipment Directive (RED) 2014/53/EU. A Declaration of Conformity in accordance with the above regulations has been made and is on file with RDT, see RDT contact details. The wireless portion of this equipment may be operated in GB, France, Italy, Switzerland, Germany, Holland, Portugal, Spain, Sweden, Norway, Denmark and Finland. 1.2 FDA prescription statement Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician. 1.3 Proprietary notice Information contained in this document is copyright 2013-2019 by Remote Diagnostic Technologies Limited ('RDT') and may not be reproduced in full or in part by any means or in any form by any person without prior written permission from RDT. The purpose of this document is to provide the user with adequately detailed information to efficiently install, operate, maintain and order spare parts for the Tempus Pro. Every effort has been made to keep the information contained in this document current and accurate as of the date of publication or revision. However, no guarantee is given or implied that the document is error free or that it is accurate with regard to any specification. RDT reserves the right to change specifications without notice. Tempus Pro, Corsium, Corsium Crew, RachBak, i2i and TempusNET are all trademarks of RDT. The Bluetooth name and logo are owned by the Bluetooth SIG Inc. and any use of this name or mark is under license. The following trademarks are the property of Oridion Medical Ltd.: Oridion, Microstream, FilterLine,

(FilterLine Set; FilterLine H Set, Nasal FilterLine), CapnoLine (Smart CapnoLine, Smart CapnoLine O2, Smart CapnoLine Plus, Smart CapnoLine Plus O2, Smart CapnoLine H Plus, Smart CapnoLine H Plus O) and Integrated Pulmonary Index (IPI). The following trademarks are the property of Masimo Inc, SET, PVI, Rainbow, FastSAT. NO IMPLIED LICENSE Possession or purchase of this device does not convey any expressed or implied license to use the device with unauthorized sensors or cables that would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. Masimo and the Masimo SET logo are the property of Masimo Inc. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 10 1.6 Features list 1.4 Use of this manual The instructions and safety precautions provided in this manual must be observed during all phases of the operation, usage, service or repair of the Tempus or its accessories. Failure to comply with the information contained in this manual e.g. warnings, precautions, instructions etc. will violate the safety standards of design, manufacture and intended use of the products. Remote Diagnostic Technologies Ltd. assumes no liability for customer failure to comply with the information contained in this manual. WARNING CAUTION The Tempus is intended to be operated by clinically qualified personnel only. This manual, as well as accessory directions for use and all precautionary information and specifications should be read before use. Separate manuals are provided for the setup and maintenance of the device. These manuals are intended for the communications engineers and Bio-medical engineers responsible for such activities and are available from RDT upon request. Please check RDTs website regularly for new versions of this manual: https://www.rdtltd.com/support-and-

resource-centre/. To access the manual, you will need to enter the following details:

Username TEMPUSPROnnnn Password w265nnnn nnnn is the last four digits of your Tempus Pro serial number. 1.5 Intended users RDT assumes that users of the product are clinically trained in how to take and interpret a patients vital signs. The Tempus Pro and this manual are intended to be used by such clinically-trained personnel. While the Tempus Pro has been designed as a good quality monitor; RDT reminds users that no monitor can replace good clinical judgment or the care and attention of a clinician. Before attempting to work with this equipment, the user must read, understand note and strictly observer all warnings, cautions and safety markings in this manual, other associated labelling and on the equipment. It is the users responsibility to ensure they are properly prepared to use the product. No formal training should be required so long as the user reads this manual thoroughly and familiarises themselves with the product before use. RDT can provide direct training courses if preferred. 1.6 Features list All Tempus Pro monitors come with the following items:

Lithium-ion battery Non-invasive blood pressure hose Non-invasive blood pressure cuff Masimo patient cable Tempus Pro ECG cable Tempus mains power supply and mains cable Tempus Pro user manual set (CD-ROM) The following additional items may be included:

Configurations with a built in capnometer (optional) are provided with an Oridion Military and Air Medical Sample Pack. Configurations can include an optional 2 Channel Invasive Pressure Module (part number 01-2017). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 11 Chapter 1 Introduction 1.7 Patent and warranty 1.7.1 Patent claims RDT has applied for patents covering the Tempus Pro and its communications technology in the following jurisdictions: Patents Pending (US No.2006/0287586 EP 1734458 A & other areas). The capnography component of this product is covered by one or more of the following US patents:

6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending. PATENT MARKING: This device is covered under one or more of the following U.S.A. patents:5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975, 7,469,157and other applicable patents listed at http://www.masimo.com/patents.htm. 1.7.2 Limited warranty Remote Diagnostic Technologies Limited ('RDT') warrants each new Tempus to be free from defects in workmanship and materials under normal conditions of use and service. For details please refer to the Terms and Conditions of Sale. Consumable items are expressly excluded from this Warranty. RDT's sole obligation under this warranty will be to repair or (at RDT's option) replace products that prove to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, RDT makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. The warranty shall be void if the Tempus is in any way modified or used with non-approved consumables, unless specifically authorised in writing by RDT, and RDT shall not be liable in any event for incidental or consequential damage. This warranty is not assignable. Full terms and conditions of sale are available from RDT and are provided with your order confirmation. All specifications quoted in this manual are nominal unless detailed otherwise. 1.7.3 Service support and returns Repairs made under warranty to any Tempus must be made by the manufacturer. If the device requires repair or return for any reason, please contact your local distributor or Remote Diagnostic Technologies in order to first obtain a returns reference (RMA) number, see RDT contact details. RDT reserves the right not to accept returns which have not first been provided with an RMA number. When calling, please be ready to quote the serial number of the device. The Tempus Pro is designed to be as maintenance free as possible. The only user replaceable and user serviceable parts are those listed in section 11 of this manual. In the event that the Tempus Pro fails to operate correctly or in a way that is not described in this manual, stop using the device immediately and switch the device off immediately. Contact the manufacturer or distributor at once. Do not attempt any kind of corrective action and do not connect the device to a patient. If the device malfunctions and may have caused or contributed to a serious injury of a patient or user, RDT must be notified immediately by telephone, fax or written correspondence. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 12 2 Warnings and cautions 2.1 Safety and note icons This manual uses the following icons are used to indicate safety, caution and warning messages

(per ISO 3864-2):

DANGER WARNING CAUTION Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury. The note icon is used for important and helpful information:

Note A point of particular interest or emphasis intended to provide more effective or convenient operation. 2.2 EMC information The Tempus Pro Patient Monitor has been tested and approved to IEC/EN60601-1-2:2014. This means that the Tempus meets or exceeds the requirements for electrical medical equipment in terms of its levels of emitted electromagnetic (EM) radiation and its susceptibility to electromagnetic radiation from other devices. In addition, the Tempus Pro has been tested according to the requirements of RTCA DO-160-G section 21 category M. It should be noted that the Tempus Pro may be affected by high levels of stray EM radiation from other electronic devices (even those which comply with relevant CISPR emission standards) that are being used in close proximity to it. As required by international medical device standards, the Tempus Pro is intended for use in electromagnetic environments of 8kV static contact (15kV air discharge) and magnetic fields of 30 A/m

(50/60Hz). The Tempus Pro is proof against radiated RF emissions from 80MHz to 2.7GHz to a level of at least 3V/m. In the event that the Tempus Pro will be used in environments with RF levels exceeding this, please contact RDT for further information. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 13 Chapter 2 Warnings and cautions WARNING WARNING WARNING Operating high frequency electrosurgical equipment in the vicinity of the monitor can produce interference in the monitor and cause incorrect measurements. Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the function of the monitor may be disturbed. This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Tempus or shielding the location. CAUTION Tempus has been tested in a heavy wireless environments consisting of different wireless technologies (Bluetooth, WiFi 802.11 b and cellular communications) with multiple transmitters used simultaneously. Users deploying the Tempus in environments where other wireless technologies are being used should evaluate the potential risk of interference and aggregate spectrum usage. 2.3 Indications for use The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-

hospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/alarming and ST measurements/alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2

(ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxyhaemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates. The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts/Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. The monitor can also be used to display the following readings from a Masimo ISA OR+ gas module*: end-tidal and fractionally inspired CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane. These optional accessories are to be used in accordance with their indications for use.

* Not cleared for use with the Tempus Pro in Canada or the USA. 2.3.1 Contraindications The Tempus Pro does not replace a physicians care. The device is not an apnoea monitor. The Tempus Pro is not intended to be used in strong magnetic or electro-magnetic fields which are generated for medical purposes e.g. MRI. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 14 2.4 General warnings, cautions and notes 2.4 General warnings, cautions and notes DANGER DANGER WARNING WARNING WARNING WARNING WARNING ELECTRICAL SHOCK HAZARD when covers are removed. Do not remove covers. Refer servicing to qualified personnel authorised by RDT. Explosion Hazard: DO NOT use the Tempus Pro in the presence of flammable gasses such as fuels. Use of the Tempus Pro in such environment may present an explosion hazard. The FilterLine may ignite in the presence of O2 when directly exposed to laser, ESU devices, or high heat. When performing head and neck procedures involving laser, electrosurgical devices or high heat, use with caution to prevent flammability of the FilterLine or surrounding surgical drapes. The use of the read the user manual before using the product. or the or the symbols indicates that the user must When used with the mains power supply, to avoid the risk of electric shock the power supply must only be connected to a supply mains with a protective earth. Do not connect the Tempus Pro to an electrical outlet controlled by a wall switch or dimmer. To ensure patient electrical isolation, only connect Tempus Pro to other systems which are compliant with the relevant IEC standard e.g. IEC60950, and which employ suitably electronically isolated circuits. Signal input and output connectors are only for connection to equipment complying with relevant IEC safety standards and must be configured to comply with IEC60601-1-1 or IEC60601-1:2005. WARNING Attaching different medical systems together can cause increases in leakage currents. If the Tempus is connected to other medical devices, or if the patient has multiple devices attached to them at the same time, the cumulative effect of leakage currents must be considered. WARNING WARNING WARNING WARNING WARNING Do not touch the patient at the same time as touching the body or contacts of any of the medical or communications or power connectors. Many environmental variables, including patient physiology and clinical application, can affect the accuracy and performance of the monitor. The clinician must verify all vital-signs information prior to patient intervention. Do not autoclave, ethylene oxide sterilise, or immerse in liquid the Tempus or any of its cables or accessories as this may cause sensor damage which may result in inaccurate readings. Attention should be paid to the following EMC information prior to installing or using the device. The Tempus should not be stacked next to other equipment. If this is necessary verify normal operation if utilizing device adjacent to or stacked with other electrical equipment. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 15 Chapter 2 Warnings and cautions WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of the device. Computers, cables and accessories not tested to IEC/EN60601-1-2 or equivalent IEC standards may result in increased emissions or decreased immunity of the device. Follow precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other equipment. Only use Tempus Pro with the relevant cables and peripherals provided by RDT. Use of any other accessories could result in inaccurate measurements. Use of any other cables or accessories could affect defibrillator protection. Exposure of the wireless communication features of the Tempus Pro or its accessories may be interfered with by other devices which operate at the same frequencies. The sensors of the Tempus Pro are only for contact with intact and undamaged skin. Any device or accessory that has been dropped, damaged or subjected to harsh usage or extreme environmental conditions should be inspected by qualified service personnel prior to use to ensure proper operation. The ECG device is not intended for use in a sterile environment. Do not use for direct cardiac application. Do not attempt to insert the ECG device (including patient cables) into an electrical outlet. The ECG recorder and monitoring functions are for resting ECG and should not be used in stress testing environments. Though false positive errors will intentionally outnumber false negative errors, both will occur, thus the necessity for over reading by a qualified physician of any computer-interpreted ECG. The computer interpretation does not produce a definitive diagnosis. Ensure electrodes are connected only to patient. Conductive parts of electrodes and connectors, including neutral electrode, should not contact other conductive parts including earth. Always keep motion to a minimum. Motion artefact can potentially affect the accuracy of patient readings. Do not connect more than one patient to a monitor. Do not connect more than one monitor to a patient. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 16 2.4 General warnings, cautions and notes WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Do not use the Tempus in a Magnetic Resonance Imaging (MRI) suite or a hyperbaric chamber. Do not place the monitor or its accessories in locations where they could fall onto the patient. When moving the product take care that any connected leads and sensors are not jerked so that they become detached or damaged. The Tempus Pro is protected against defibrillator discharge but rate meters and displays may be temporarily affected during defibrillator discharge but will rapidly recover. During defibrillation, keep the defibrillators paddles or electrodes away from the monitors ECG wires, electrodes and any other sensors or conductive parts of the monitor. Pacemaker signals can differ from one pacemaker to the next. The Association for Advancement of Medical Instrumentation (AAMI) cautions that in some devices, rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. All pacemaker patients should be kept under close or constant observation. Device may not operate effectively on patients who are experiencing convulsions or tremors. Misuse or improper handling of the device or its sensors or cables can cause damage which may lead to equipment failure or inaccurate readings. Do not apply excessive tension to any cable. Using a damaged patient sensor may cause inaccurate readings, possibly resulting in patient injury or death. Inspect each sensor. If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair centre for help. The Tempus and all its cables and accessories should be inspected frequently to check for damage. Any worn or damaged items should be replaced. Failing to thoroughly and regularly inspect and maintain the product could result in hazards to patients or equipment failure. Using a damaged patient cable may cause inaccurate readings, possibly resulting in injury or death. Inspect the patient cable. If the patient cable appears damaged, do not use it. Contact your authorized repair centre for help. Ensure that close attention is paid to the alarm configuration settings of the product. If alarm volumes are turned down or if the product is used in noisy environments, then the alarm may not be audible. If alarms are muted this will be indicated on the screen. Always ensure the screen of the Tempus can be seen in case the audible alarms cannot be heard or are turned off. Do not attempt to charge a non-rechargeable battery. Never over charge, crush, heat or incinerate, short-circuit, deform, puncture, dismantle or immerse the batteries in any liquid. Only use rechargeable batteries and battery chargers specified by RDT. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 17 Chapter 2 Warnings and cautions WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Ensure patient cabling or tubing is carefully routed on device to reduce the possibility of patient entanglement or strangulation. All numerical, graphical and interpretive data should be evaluated with respect to the patient's clinical and historical picture. Do not attempt to insert any connections from the Tempus Pro (including patient cables) directly into an electrical outlet. (IEC60601-2-34:2011, 2011). Failure of Operation: If the Tempus Pro fails to respond as described in this user guide; DO NOT use it until approved for use by qualified personnel. Reuse, disassembly, cleaning, disinfecting or sterilizing of any single use items (such as the Capnometer cannula) may compromise functionality and system performance leading to a user or patient hazard. Performance is not guaranteed if an item labelled as single patient use is reused. Do not touch the patient at the same time as touching the body or contacts of any of the medical or communications or power connectors. The USB connection must only be connected to non-mains powered peripherals

(such as a mouse or keyboard) or to interface accessories provided by RDT (such as the USB-Serial Cable part number 01-1022). Any connections made to the USB port must be to medical or IT peripherals or communications systems which comply with the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection arrangements must be made in a manner compliant with IEC60601-1-1 or IEC60601-

1:2005. The alarm functions of the Tempus are intended to be used by the attendant user only. If the device is connected to a Response Centre this is for the purpose of sharing vital signs data in real time, between two users for the purpose of obtaining additional clinical support. The system is not a distributed alarm system (e.g. nurse monitoring station system) in the terms of IEC60601-1-8. The i2i system at the Response Centre is not equipped with alarm silencing or suspending controls. When connected to a PC running the i2i application at a Response Centre, streamed data, such as the waveforms displayed on the Tempus Pro, will be transmitted and displayed automatically on that PCs display. Users are advised that streamed data are transmitted using the UDP protocol. The UDP protocol includes error checking but does not retransmit data. Therefore, any data that is dropped, lost or delayed during the streaming process will not be retransmitted. In the event that packets of waveform data are lost, they will appear as gaps in the waveform that is displayed on the i2i interface. WARNING Medical data (vital signs data, photos, ECG recordings, patient details, TCCC cards etc.) are transmitted using TCP/IP, this includes error checking and retransmission so missing or dropped packets are therefore retransmitted. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 18 2.4 General warnings, cautions and notes WARNING Do not disassemble the device. The device must only be serviced by trained and authorised biomedical engineers following RDT approved procedures and using parts provided by RDT. Any other changes or processes are unauthorised and should not be performed. No other modifications are allowed. Unauthorised processes, repairs, modifications, reworks or service not expressly approved by RDT could void any guarantees and warrantee and could be hazardous. Do not modify this device without authorisation from RDT. If the device is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the device. CAUTION The Tempus may be used on ambulances or on vehicles using radios. As detailed in section 14.5, it has been tested to determine operation in field strengths greater than 3V/m. Users are advised to maintain the best distance possible between radio antennas and the Tempus as best practice. CAUTION CAUTION CAUTION CAUTION CAUTION This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the information in this manual before using the device. The Tempus Pro may not operate correctly if used or stored outside the relevant temperature or humidity ranges described in the performance specifications of this manual. Only use only approved accessories supplied by RDT. Conventional 4mm snap-on, pre-

gelled ECG electrodes may be used so long as they comply with AAMI EC12. Users are reminded to read and adhere to the instructions for such electrodes including noting single use only status, maximum usage times and patient indications. Do not clean the Tempus or its accessories except as directed in this guide. In the event that the device displays an error that is not described within this manual e.g. applications errors, turn the device off and then on again. This should clear the error and allow normal operation to resume. Do not continue to use the device if such an error is displayed. If symptoms persist, please contact RDT. CAUTION The Tempus records all data that it measures. In order to ensure that data from different patients is not confused, the device must be switched off between taking readings from different patients or the patient discharge function used. CAUTION Should the device become wet, wipe off all moisture and allow sufficient time for drying before operating. Take care to ensure that water or liquids are not spilt over the device or into its ventilation holes in the side corners. CAUTION CAUTION CAUTION If the accuracy of any measurement is in question, verify the patient's vital sign(s) by an alternative method and then check the monitor for proper functioning. Follow local government regulations and recycling instructions regarding disposal and recycling of device and device components. The Tempus Pro and its accessories use different types of batteries which includes rechargeable and non-rechargeable types. If any battery fails to hold a charge or otherwise becomes inoperable, the battery should be replaced and the old battery should be disposed of properly. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 19 Chapter 2 Warnings and cautions CAUTION CAUTION CAUTION Dispose of batteries in accordance with applicable regulations which vary from country to country. In most countries, the disposal of used batteries is forbidden in general domestic and commercial waste and the end-users are invited to dispose of them properly, typically through not-for-profit profit organisations, mandated by local governments or organised on a voluntary basis by professionals. Pressing buttons or the touch screen with sharp or pointed instruments may cause permanent damage. Only fingers should be used to press these keys. Do not reconnect the headset to its docking pin when the main battery is very low or flat

(less than 10% charge as represented by a single flashing LED on the battery charge indicator). Doing this could reduce the battery charge into a deep discharge state (where no battery lights come on). CAUTION Use of monitoring during continuous nebulised medication delivery will result in damage to the device which is not covered by the warranty. Disconnect the Capnometer sample line from the device, or switch off the device, during medication delivery. CAUTION CAUTION CAUTION CAUTION Observe proper battery polarity (direction) when replacing batteries. The batteries slide easily into place when correctly oriented and should not be forced. The mobile RF communications equipment contained within the device and its accessories can affect other medical devices that are in close proximity to the device. Use of the RF communications equipment contained in the device and its accessories may be prohibited in a number of areas. These include: on aircraft in-flight (including during take-off and landing), near defibrillators (that are in use), near other electronic medical devices and in hospitals. In addition, the use of the RF communications equipment contained in the device and its accessories may be prohibited in explosive atmospheres e.g. in fuelling areas, near fuel or chemical transfer or storage areas and in areas containing chemicals or particles such as grain, dust or metal powders. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 20 2.4 General warnings, cautions and notes CAUTION The use of the RF communications equipment contained in the device and its accessories may cause interference with implanted pacemakers and other medically implanted equipment. A minimum distance of 2.3 m (7.5 ft) must be maintained between the device and its accessories (containing RF communications equipment) and other medical equipment

(including implantable medical devices such as defibrillators and pacemakers). If such medical equipment has an electromagnetic interference immunity level of less than 3V/m (or 10V/m for implantable devices), this distance should be increased in line with the requirements of IEC60601-1-2:2014. If the intended patient has an implantable device (e.g. pacemaker), do not use any of the Tempus Pros RF communications equipment (e.g. Bluetooth or WiFi) before using the device to record the patient's physiological data. After the data recording session is completed, move the device at least 2.3 m (7.5 ft) away from the patient, and then use it normally to communicate with the base station. Otherwise, radiofrequency radiation from the device (up to 63mW) may adversely impact the implantable pacemaker in the patient. If the patient's implantable device has an immunity level less than 10 V/m, the separation has to be greater than 2.3 m (7.5 ft). If you suspect interference is being caused, disconnect from the Response Centre by

. Interference could include visible interference on equipment displays, audible pressing interference e.g. buzzing, from speakers of other equipment, or equipment unexpectedly changing state e.g. functions starting or stopping. Example of a PC display without interference:

Example of a PC display with interference:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 21 Chapter 2 Warnings and cautions CAUTION When using the device with GAN terminals, in order to avoid the risk of interference from the output beam from the antenna of the terminal with the operation of the device, ALWAYS ensure that the device is situated at least 6m behind the face of the antenna. Since the power of the GAN terminals beam is high (25W approx.), care should be taken to ensure that the antenna remains fixed and to maintain the device away from the face (and therefore the beam) of the antenna. CAUTION RF energy may affect some electronic systems in motor vehicles, such as car stereo, safety equipment, etc. Check with your vehicle manufacturers representative to be sure that your product will not affect the electronic system in your vehicle. CAUTION CAUTION CAUTION CAUTION Note Note Note Note Note Note Note Note Note Do not use the Tempus Pros Bluetooth or WiFi communications on-board any aircraft where its use is prohibited. Take care to minimise the risk that trailing cables will be caught by passers by. Prior to deployment of Tempus Pro there are settings that user organisations need to configure. Carefully check all the relevant settings on each Tempus Pro before it is deployed. For more information, see 4.1 Before deployment. If you use mounting systems that are not supplied or approved by RDT, we cannot guarantee the performance of the Tempus Pro. The Tempus has been tested and found to comply with IEC/EN 60601-1-2. If all the battery lights remain off when the battery button is pressed, the battery may be in a deep discharge state. The battery is not damaged when in this state but will require an extended period on an external charger (additional 24 hours) in order to restore normal operation. Important! The Tempus Pro is intended for use in the electromagnetic environment(s) specified in this manual. Users of this equipment should ensure that it is used in such environment(s). After the life cycle of the Tempus Pro and its accessories have been met, disposal should be accomplished following national and/or local requirements. Operation of the device may be adversely affected in the presence of conducted electrical transients or strong electromagnetic or radio frequency sources such as electrosurgery and electrocautery equipment, HF radio transmission antenna, x-ray machines and high intensity infrared radiation. All user and patient accessible materials are non-toxic. Hazards arising from software errors have been minimised. Hazard analysis was performed to meet the requirements of EN14971 and IEC60601-1-4. Each external connection and part of the device is electrically isolated. Performance and safety test data are available on request from RDT, see RDT contact details. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 22 2.4 General warnings, cautions and notes Note Note Note Note Note Note Note Note Note Note Note GSM usage is restricted by the network availability, roaming agreements and local provision of circuit mode connections. IP sealing is not guaranteed if the device is subject to rough handling, impact, improper use or rapid decompression. Device should be returned for service if it is subject to rough handling and IP sealing is needed to be relied upon. The device specifications are subject to change without notice. It is recommended that the device is connected to the Response Centre every month for a test patch. The iAssist help processes on your Tempus Pro may differ from the example iAssist help process used in this manual; however, the process always follows the same key elements. Always ensure that you read the complete iAssist help process in order and do exactly what it requires. For optimum performance of the wireless communications, please make sure that there is no metal surrounding the Tempus Pro. Over bending the folding foot or RapidPak clip could cause them to be damaged. Do not over-bend these items. Take care when repacking cables to ensure they cannot be snagged or damaged in the RapidPak clip and the folding foot. The Tempus Pro should be repacked following the relevant instructions. Lost or damaged cables and accessories should be replaced with spares ordered from RDT. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 23 Chapter 2 Warnings and cautions Tempus Pro User/Operator Manual - 41-2001EN-00 Page 24 3 Introduction to the Tempus Pro The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital and remote locations. It provides the user with conventional patient monitoring parameters for use in measuring and monitoring patients vital signs. The device also provides the user with the ability to capture patient incident data in electronic format. This data can be passed from one Tempus to another to enable the patients record to remain with them as they move from one caregiver to another. In addition, the device also gives the user the ability to transmit all data in real-time to a Response Centre using a variety of integrated communications interfaces. If data is being transmitted, the device also allows the user to transmit still or moving pictures via an integrated digital camera and also to speak to the Response Centre using a wired or wireless headset. The Tempus Pro is intended to be used by trained clinical staff. The Tempus Pro can provide the following information about the patient from its sensors:

ECG Monitoring;

Impedance pneumography (respiration rate measured through ECG leads);

Real-time arrhythmia detection and alarming;

Real-time ST and QT measurement and alarming;

12 Lead Diagnostic ECG Recording;

12 lead ECG recording interpretation;

Heart rate (from ECG) or pulse rate (from pulse oximetry);

Non-invasive blood pressure;

End tidal CO2 (ETCO2);

Respiration rate;

Pulse Oximetry including Oxygen saturation (SpO2) pulse oximetry (SpO2), Total Haemoglobin

(SpHb), Methaemoglobin saturation (SpMet), Carboxyhaemoglobin (SpCO), Oxygen Content (SpOC), Pleth Variability Index (PVI);

Temperature;

Invasive pressure. Tempus Pro is also able to display ultrasound and video laryngoscopy images on its large colour display utilising third party ultrasound probes and video laryngoscopy accessories. For more information, please refer to Tempus Pro Ultrasound Supplement Guide (Part number 42-2003) and Tempus Pro Laryngoscope Supplement Manual (Part number 42-2004). To display anaesthetic agent gas vital signs on the Tempus Pro, you can use the Masimo ISA OR+

Anaesthetic Gas module (available from RDT). For more information, see the Tempus Pro AA Gas Supplement Guide. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 25 Chapter 3 Introduction to the Tempus Pro 3.1 Overview of the Tempus Pro The Tempus Pro consists of a PC-ABS plastic enclosure which is over-moulded with TPU material to make it resistant to shock. The enclosure also includes the RapidPakTM clip which provides storage for the SpO2 sensor, the adult NIBP cuff and hose and the ECG cable. The unit has a clear window on the top which contains the alarm bar. This lights yellow or red for clinical alarms. The alarm bar can be configured by the user to light green in all non-alarm conditions. The alarm bar has a small aperture at the rear of the case which allows the alarm status to be seen from the rear. In addition, light from the alarm bar is distributed by the translucent handle which sits across the top of the device. 3.2 Key features of the unit 3.2.1 Tempus Pro front On the front of the unit is a large, colour display which is fitted with a touchscreen. The touchscreen may be used with a gloved hand or plastic stylus. Around the touchscreen are two panels of membrane buttons

(left/below and right). Also on the front are grilles covering the alarm speaker. Care should be taken not to probe through the grilles with any sharp or pointed object. Carry strap Alarm Bar Membrane buttons Speaker Touchscreen Battery The Tempus Pro 3.2.2 Tempus Pro base The base of the Tempus Pro houses the battery. The battery can be removed by pushing the latches at each end of the battery together. This will release the battery allowing it to be pulled out. The battery includes a charge level button and four indicator lights. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 26 3.2 Key features of the unit 3.2.3 Tempus Pro rear Non-printer models If the Tempus Pro is not fitted with an internal printer (part number 00-1004-R or 00-1007-R):

The rear houses the RapidPak clip (discussed above). Also on the rear is the aperture for the camera and backlight. The clip carries a general product label for regulatory purposes and also two labels which help guide the user to repack the SpO2 sensor and the ECG cable. If the Tempus Pro is a non-printer model with Bluetooth headset (part number 00-1007-R):

The Bluetooth headset is docked onto a connector which enables the Tempus Pro to top its charge up automatically on a regular basis, thus ensuring the headset is always ready to use. The Bluetooth headset is a Sennheiser Presence or Sennheiser VMX200. Rear alarm light Camera and backlight Heatsink 3 or 5 wire ECG Cable BP cuff SpO2 sensor The Rear of the Tempus Pro (non-printer model) Tempus Pro User/Operator Manual - 41-2001EN-00 Page 27 Chapter 3 Introduction to the Tempus Pro Printer models If the Tempus Pro is a printer model (part number 00-1022-R, 00-1024-R or 00-1026-R):

The rear houses the internal thermal printer. Also on the rear are the camera, backlight and moveable foot. The RapidPak clip is absent. The ECG cables, SpO2 sensor and NIBP cuff are stored in the bag.

(1) Rear alarm light

(2) Camera and backlight

(3) Printer The Rear of the Tempus Pro (printer model) 3.2.4 Tempus Pro left side The left side of the device contains seven connectors for:

ECG monitoring and Diagnostic ECG - green;

NIBP - white latching connector;

Pulse oximeter (SpO2 and pulse rate) light grey Capnometer (ETCO2 and respiration rate) - yellow;

Contact temperature (2 sockets marked T1 & T2) - turquoise. Invasive pressure white;

WARNING CAUTION Do not touch the patient at the same time as touching the body or contacts of any of the medical or communications or power connectors. Consideration needs to be made to the potential for leakage currents to be created if the Tempus or its connectors are made wet or dusty. In the event that any connectors (but particularly patient leads i.e. ECG, Invasive Pressure, SpO2, contact temperature) or their respective sockets become wet or contaminated with sand or dust, they should be cleaned and dried before use see 10.2.4 Cleaning the NIBP cuffs and hose. Connectors and their immediate surrounding areas should be clean and dry at all times. Normally the ECG, NIBP and SpO2 connectors will have their sensor cables attached at all times. The Tempus connectors are rated IP66 in their own right and are therefore water proof and sand proof against ingress of water or particulate into the devices enclosure without the covers. The covers provide Tempus Pro User/Operator Manual - 41-2001EN-00 Page 28 additional protection to prevent nuisance ingress of sand into the connectors in the event that a cable or sensor is not in place. 3.2 Key features of the unit ECG cable NIBP hose Pulse Oximetry

(SpO2) patient cable Invasive Pressure door Capnometer door Contact Temperature doors Left side of the Tempus medical connectors 3.2.5 Tempus Pro right side The right side of the Tempus houses the data communication and power connections. These comprise:

Two USB 1.0 & 2.0 sockets these are reserved ONLY for non-mains powered radios (or other communications devices), non-mains powered USB peripherals (such as keyboards) or non-mains powered medical accessories. Any accessory or peripheral attached to the Tempus MUST be approved for use with the Tempus Pro by RDT. Mains Power only use the Tempus Pro approved mains power supply part number 01-2049 provided by RDT. Audio this is only for use with the Wired Headset (part number 01-1019) supplied by RDT or for use with the Tactical Headset Adaptor Cable (part number 01-2041) supplied by RDT (this cable adapts to Peltor or similar military-style headsets). Tactical Switch this switch allows the user to switch the Tempus visual and audible outputs to a minimal setting and is described in section 4.3.2. WARNING The USB connection must only be connected to non-mains powered peripherals approved by RDT and documented in this manual, or to interface accessories provided by RDT. Any connections made to the USB port must be to medical or IT peripherals or communications systems which comply with the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection arrangements must be made in a manner compliant with IEC60601-1. Users must ensure that they prevent the patient from coming into contact with the peripheral and also must ensure the user does not touch the peripheral while touching the patient. Alternatively, a suitable isolation device can be used. RDT recommends the use of appropriate opto-isolation devices such as the Ulinx Model UH401 or the Baaske USB 1.1 isolator. Further details can be obtained from RDT upon request. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 29 Chapter 3 Introduction to the Tempus Pro WARNING WARNING WARNING WARNING CAUTION CAUTION Always use a Baaske MI 1005 isolation device when connecting from the Ethernet socket to any mains-powered communications device (e.g. router, access point, hub, communications terminal etc.). The Ethernet connection must only be connected to battery powered (non-mains-

powered) communications devices such as laptop computers or satellite communications terminals such as BGAN or VSAT terminals. Any connections made to the Ethernet port must be to medical or IT peripherals or communications systems which comply with the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection arrangements must be made in a manner compliant with IEC60601-

1:2005 or IEC60601-1-1:2001. Users must ensure that they maintain the communications device 1.5 m away from the patient and also must ensure the user does not touch the communications device while touching the patient. If such devices require mains power then the device must be powered using a power supply compliant with the electrical isolation requirements IEC60601-1. The audio connector must only be connected to unpowered microphone headsets or battery powered microphone headsets (such as Peltor or Bose). Further details can be obtained from RDT upon request. Do not touch the patient at the same time as touching the body or contacts of any of the medical or communications or power connectors. Do not use USB hubs (powered or unpowered) with the Tempus. This could cause the USB sockets to cease operating. Consideration needs to be made to the potential for leakage currents to be created if the Tempus or its connectors are made wet or dusty. In the event that any or their respective sockets become wet or contaminated with sand or dust, they should be cleaned and dried before use see 10.2.3 Cleaning connectors. Connectors and their immediate surrounding areas should be clean and dry at all times. Ensure the communications connectors are securely covered with their dust covers (if fitted) at all times. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 30 3.3 Theory of operation Power socket Headset socket Tactical switch Ethernet RJ-45 socket Two USB A sockets for USB 1.0 & 2.0 communications Right Side of the Tempus Communications Connectors 3.3 Theory of operation All of the measurements made by the Tempus Pro are displayed on the screen. Attaching a sensor to a patient will initiate measurements by that particular parameter. Monitoring will continue until the sensor is removed from the patient or the unit (and the consequent alarm is silenced). In the case of non-invasive blood pressure, measurements start once the user presses the start button and will continue on a regular basis when in automatic mode until either the cycle is stopped by the user or the unit is unable to take a reading e.g. cuff is removed. 3.3.1 Pulse rate and oxygen saturation (SpO2) Pulse oximetry measures functional oxygen saturation. Pulse oximetry is based on the following:

The difference in the absorption of red and infrared light (spectrophotometry) by oxyhaemoglobin and deoxyhaemoglobin Changes in the volume of arterial blood in tissue during the pulse cycle (plethysmography), and hence, light absorption by that blood. A pulse oximeter determines Spot Oxygen Saturation (SpO2) by passing red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle. Red and infrared low power light emitting diodes (LEDs) in the oximetry sensor serve as light sources; a photodiode serves as the photo detector. Since oxyhaemoglobin and deoxyhaemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to haemoglobin oxygen saturation. To identify the oxygen saturation of arterial haemoglobin, the monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption

(measurements at systole and diastole). The focus of light absorption by pulsatile arterial blood eliminates the effects of nonpulsatile absorbers such as tissue, bone, and venous blood. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 31 Chapter 3 Introduction to the Tempus Pro Pulse rate and oxygen saturation are detected by a soft reusable finger probe packed on the rear of the device (disposable sensors may also be used). In particular it is also important that the sensor is not used on the same arm as the blood pressure cuff, because false readings may occur when the cuff is inflated. Readings will not be obtainable or may be inaccurate from patients with some colours of nail varnish or polish. Masimo SET Rainbow measurements use a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide content and blood with oxidized haemoglobin. The sensors have various light emitting diodes (LEDs) that pass light through the site to a photodiode (photodetector). The maximum radiant power of the strongest light is rated at 22 mW. The photodetector receives the light and converts it into an electronic signal. Masimo SET Rainbow signal extraction technology then calculates the measurement values. 3.3.2 Non-invasive blood pressure The Tempus Pro uses oscillometric technology to measure the patient's blood pressure non-invasively. A pump within Tempus Pro inflates the reusable blood pressure cuff around the patient's arm. Circulating blood within the arm causes slight changes (oscillations) in the cuff pressure, which can be detected and measured. As the inflation pressure changes, the systolic, diastolic and mean arterial pressure can be measured. This method of blood pressure measurement provides accurate readings provided that the correct size of cuff is used, it is attached to the patient correctly and the specified operating precautions are observed. 3.3.3 Electrocardiograph (ECG) The ECG is intended to monitor patients of all ages in hospital and pre-hospital applications (including transport) for general cardiac monitoring. Electrical currents influenced by the cardiac impulse flow through the body tissue around the heart. The Tempus Pro can be used with:

a 3-lead cable to monitor ECG leads I-III;

a 4-lead cable to monitor ECG leads I-III, AvR, AvL and AvF;

a 5-lead cable to monitor ECG leads I-III, AvR, AvL, AvF and a user-placeable V lead. Twelve lead diagnostic recording functionality is available as an option. To support this, use one of the standard or modular 12-lead cables (including precordial chest electrodes) available from RDT. ECG cables can be used with conventional disposable pre-gelled electrodes (not supplied) for ECG monitoring and alarming. 3.3.4 Impedance pneumography Impedance pneumography operates by continuously measuring changes in the impedance of the patients body. This is done using the two or more ECG electrodes and thus allows the device to measure the patients impedance through the chest. Impedance is measured using a low-current, high frequency alternating current signal. As the patient breathes, the chest expands and contracts giving a rising and falling impedance reading. The Tempus measures the time between successive peaks and troughs of the impedance measurement and translates the time into an interval or rate of respiration. The impedance method is an indirect measurement of respiration and is also subject to muscle noise and electrode placement and therefore is inferior to the respiration rate measurement provided through capnography. 3.3.5 End tidal CO2 (ETCO2) and respiration rate Tempus uses Microstream nondispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO2 present at the end of exhalation (EtCO2) and the Respiratory Rate. Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared light. Since absorption is proportional to the concentration of the absorbing molecule, CO2 concentration can be determined by comparing its absorption to that of a known standard. The Microstream EtCO2 consumables deliver a sample of the inhaled and exhaled gases from the ET tube adaptor or directly from the patient (via an oral/nasal cannula) into the monitor for CO2 measurement. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 32 3.3 Theory of operation Moisture and patient secretions are extracted from the sample, while maintaining the shape of the CO2 waveform. The 50 ml/min. sampling flow rate reduces liquid and secretion accumulation, decreasing the risk of obstruction in the sample pathway in humid ICU environments. Once inside the Microstream CO2 sensor, the gas sample goes through a micro-sample cell (15 microliters). This extremely small volume is quickly flushed, allowing for fast rise time and accurate CO2 readings, even at high respiration rates. The Micro Beam IR source illuminates the micro-sample cell and the reference cell. This proprietary IR light source generates only the specific wavelengths characteristic of the CO2 absorption spectrum. Therefore, no compensations are required when different concentrations of N2O, O2, anaesthetic agents and water vapour are present in the inhaled and exhaled breath. The IR that passes through the micro-sample cell and the IR that passes through the reference cell are measured by the IR detectors. The microprocessor in the monitor calculates the CO2 concentration by comparing the signals from both detectors. 3.3.6 Temperature Two channels of contact temperature are measured through two sockets on the Tempus. These sockets are compatible with YSI type 400 probes only. A range of third-party YSI 400 series compatible transducers may be used with the Tempus. These transducers may be re-usable or disposable. The Tempus measures temperature by measuring the changing resistance in the tip of the transducer. When a transducer is correctly attached to the Tempus and to the patient e.g. in the rectum or axilla, the Tempus obtains a constant (direct) reading of resistance that equates to the temperature at that site. There is no offset or reference body site. The device contains a self-checking system which checks the thermometer against a known (internal) reference point (every second). If this cross-check fails at any time the thermometer will be disabled and an error posted on the display. The thermometers reading can be presented in C or F. 3.3.7 Invasive pressure Two channels of invasive pressure are measured through a socket on the Tempus. An interface cable is required to be attached to this socket, the interface cable splits into two ends, each of which can be connected to a third-party pressure transducer (with a sensitivity of 5 V/V/mmHg). A range of third-party transducers (both reusable and disposable) are available. A list of compatible sensors is provided in section 14.8. A different interface cable is required to adapt the Tempus socket to the specific connectors of each type of transducer. The Tempus measures pressure by measuring the changing resistance in the transducer. When a transducer is correctly attached to the Tempus and to the patients blood stream e.g. in the pulmonary artery, the Tempus obtains a constant reading of resistance that equates to the systolic and diastolic pressure. From this mean arterial pressure and heart rate are also calculated. The option to use two additional channels invasive pressure measurement is provided by an external USB IP Module. The 2 Channel IP Module can be located adjacent to the Tempus Pro or clipped onto a new feature on the rear clip. There is no setup required to connect the USB device to the Tempus Pro, other than plug the USB cable in. The Tempus Pro will automatically recognise that the module is attached. 3.3.8 Controls and indicators The controls and indicators are divided into three types, items on a touchscreen, membrane buttons and LED indicators. The Tempus Pro can be operated with or without gloves. Note Note Touchscreen and membrane buttons should be pressed once. As with all touchscreens if your finger wavers or quivers, the Tempus Pro may register it as more than one press. To display ultrasound and video laryngoscopy images on the Tempus Pro's large colour display, you can use third-party ultrasound probes and video laryngoscopy accessories. For more information, see the Tempus Pro Ultrasound Supplement Guide and Tempus Pro Laryngoscope Supplement Guide. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 33 Chapter 3 Introduction to the Tempus Pro 3.3.9 Summary Record of Care / Tactical Combat Casualty Care The Tempus contains an electronic patient record card known as a Summary Record of Care (SRoC). This is completed semi-automatically through the collection of vital signs and the use of the Event button. SRoC allows the user to record patient trauma details and to review historic events and trends. SRoC is automatically augmented with patient encounter data when:

An arrhythmia alarm is triggered. The Tempus Pro automatically logs an event. You can also store a snapshot of the waveform at the same time, see the All Alarms menu. A waveform snapshot is manually captured. To capture a waveform at any time, press and release the Camera & Waveform Snapshot button. A 12 Lead ECG is recorded. A camera or laryngoscope image is recorded. For laryngoscope details refer to Tempus Pro Laryngoscope Supplement Guide. An ultrasound image is recorded. Images can be taken during general and FAST exams. Refer to Tempus Pro Ultrasound Supplement Guide. Tempus Pro can also be configured to record a Tactical Combat Casualty Care (TCCC) card (this feature only applies to Tempus units configured with the TCCC patient report type); for details see 9.3.2 Updating the TCCC card. 3.3.10 Previous activity button The Previous Activity button allows the user to return to the last non-monitoring function that they were using i.e.:

TCCC card Summary Record of Care Enter patient details Discharge patient 3.3.11 Trends All vital signs are captured on the device. These can be easily viewed as a graphical or tabular trend. Also included in the trends are all alarm states and Events. 3.3.12 Data handover The Events, Trauma Record and Trend data (as well as photos and 12 Lead ECGs) are automatically collated together to form a Summary Record of Care patient report. This can be exported from the Tempus via USB and handed to the next caregiver within the care path. Should the next caregiver have a Tempus Pro, the data may then be viewed and augmented on that unit. Alternatively, the data may be viewed on any computer that is capable of reading .PDF files. 3.3.13 Email An encrypted PDF formatted Summary Record of Care can be shared using email. Encryption and data transfer are performed using FIPS- 140-2 compliant technology. 3.3.14 ePCR export Summary Record of Care data can be exported to an electronic Patient Care Reporting system (ePCR). Encryption and data transfer are performed using FIPS- 140-2 compliant technology. This feature is optional. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 34 3.3 Theory of operation 3.3.15 Communications GPS The Tempus contains a Global Positioning Satellite (GPS) receiver. This can be used to detect signals from multiple geostationary satellites to obtain a location (expressed in terms of longitude and latitude). The GPS receiver needs a clear view of the sky to work and so must be used outside. Digital camera & waveform snapshot A miniature digital camera is mounted in the unit. Still photos of the patient can be taken which are then automatically added to the patient record. Photos can be transmitted to a Response Centre at the time (if the device is connected to a Response Centre) or transmitted later. In addition, if the Tempus is connected then live moving video can be transmitted (one way from the Tempus to the Response Centre). This enables the user to show to colleagues the patient and what is happening to them. The Camera & Waveform Snapshot button is a two function key. Pressing the button will record the previous ten seconds and the following ten seconds of the waveforms for review. Pressing and holding the button will take you to the Camera & Video Options Menu. Long range voice and data communications In addition to being able to operate as a vital signs monitor, the Tempus Pro can optionally transmit all of its measurements via a communications link to a Response Centre. The device allows the Response Centre to see exactly what is on the Tempus display in real time. Therefore, the Response Centre user can see what the patients vital signs are, if they are in an alarm condition etc. In addition, the Response Centre user can control the device remotely (except for the alarm controls on the membrane keypad which are not provided to the Response Centre user). The Tempus also allows the user to talk to the Response Centre user via a wired or wireless headset. The user at the Response Centre is able to receive still photos from the device and is also able to annotate these pictures (with words, symbols and markings) and send back to the Tempus device to better illustrate the verbal instructions being given to the operator at the remote location. The Response Centre user can also receive moving video from the Tempus. The Tempus Pro can connect over either wired or wireless (WiFi) Ethernet networks. All data, voice and video that is transmitted can be secured using FIPS- 140-2 compliant encryption technology. If the device is connected to a Response Centre, then all the readings are transmitted via a communications link to a computer at a Response Centre which enables the user there to see exactly the same information that is being displayed on the device in real time. The only exceptions to this are when a 12 Lead ECG is being monitored or recorded and when a still photo is being taken in both cases the data (ECG or picture) is first recorded and then transmitted to the Response Centre. ECG data and digital pictures take the following amount of time to send to the Response Centre:

12 lead ECG recordings 1 minute Digital picture up to 30 seconds Note Note These times are for guidance only and are based on the use of a 64kbaud or greater connection. Real time data and waveforms are transmitted with up to a 5 second delay. RDT recommends that users perform a test connection to the Response Centre every month in order to verify that their communications remain open for the Tempus to use. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 35 Chapter 3 Introduction to the Tempus Pro Bluetooth communications The Tempus is fitted with a Bluetooth radio. This enables it to communicate with other Bluetooth enabled devices. The Tempus can be provided with an optional Bluetooth headset for providing voice communications. 3.3.16 On-screen user instructions The Tempus provides the user with a conventional vital signs monitoring user interface. It can also be set to provide additional on-screen instructions in the form of text and graphics. This is called iAssist mode. It is intended for use by a trained healthcare professional, who may benefit from additional instructions on how to attach the monitor to a patient. It is assumed that a more skilled or experienced user will turn the iAssist feature on before handing the device to the more junior colleague. iAssist is intended to make the device easier to use, provide on-screen instructions and provide context sensitive errors in order to help the user apply the device. It does not change the behaviour of the patient or technical alarms except to provide more on-screen and graphical instructions in some cases. Using iAssist means that the format of the results (Home Screen) changes from a 4 channel (2 ECG, Plethysmogram and Capnogram) layout to a 3 channel (1 ECG, Plethysmogram and Capnogram) layout. iAssist instructions are available for ECG monitoring, Non-Invasive Blood Pressure, Pulse Oximetry, Contact Temperature and Capnography. iAssist instructions are not available for invasive pressure as this process requires specific training and is surgically invasive. Instructions are not included for use of a 10-wire ECG cable as this requires specific training. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 36 4 Setting up 4.1 Before deployment Prior to deployment of Tempus Pro there are settings that user organisations need to configure. Carefully check all the relevant settings on each Tempus Pro before it is deployed. When deploying multiple units, you may set up a single unit and export the configuration from one unit to the others (cloning the settings). Three types of configuration are exporting and imported:

events (summary record of care);

new patient defaults;

settings. summary record of care assessment, intervention, drug and fluid events;

Summary record of care events include:

summary record of care injury and burns body map tags;

summary record of care general screen events selection. New patient defaults include:

patient alarm limits for all parameters;

default patient mode (adult, paediatric or neonate);

alarm silence and suspend times;

default NIBP settings (mode, auto-time and inflation pressures);

default ECG settings (HR/PR source, ST/QT etc.).;

printer default settings. communications menu;

communications settings (e.g. IP address);

Settings include:

email settings;

ePCR settings;

patient record type, language, passwords. Note Note Note Configuration needs to be carried out by a biomedical engineer or suitably qualified person following the instructions in the Tempus Pro Configuration Utility User Guide. The unit name is not cloned from one device to another. Licensed options and enabled features are not cloned from one device to another. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 37 Chapter 4 Setting up 4.2 Unpacking the Tempus Pro The Tempus Pro is supplied from the factory in protective outer packaging. No special precautions are required when unpacking the Tempus Pro. RDT recommends that you keep the packaging. RDT recommends that the equipment is inspected and tested on receipt to confirm that the unit has not been damaged and that all expected items and accessories have been received and are in working order. New batteries should be charged up for at least 4 hours on receipt. Users should ensure that all expected items are received with the Tempus when first opening the delivery case. The Tempus Pro As detailed in section 1.6 Features list, the Tempus Pro is supplied in a number of configurations. Confirm that all items ordered have been received. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 38 4.3 Starting and stopping the Tempus Pro and selecting a patient 4.3 Starting and stopping the Tempus Pro and selecting a patient 4.3.1 Switching on WARNING CAUTION Ensure the latches on both sides of the battery are fully engaged prior to using the Tempus - an incorrectly fitted battery could result in the Tempus losing power during use. Do not press any of the controls until the Tempus has started. To switch on the Tempus Pro, press and hold the button on the front panel for 1 second. The LED on the the LED shines green constantly. button will flash green. The device is ready for use when When the Tempus starts it will briefly light the alarm bar and sound the patient alarm. This is to demonstrate that these functions are operational and must be checked by the user (with the tactical switch off). 4.3.2 Tactical mode (optional) WARNING WARNING To ensure that the Tempus Pro is safe to use when colleagues are using NVGs (night vision goggles), use only the settings in the green shaded NVG areas of the Tactical Menu: LED Indicators set to off, Brightness set to Min, Low or Mid. The Tactical Switch is intended for use by military and civilian pre-hospital care users for scenarios where low emitted light and low emitted sound is required or desired. Users are reminded that while these functions are enabled, the device will not emit visual alarms from the alarm bar, will not emit audible alarms from the speaker and may present a display that may be too dim to see in daylight conditions. Users should therefore ensure that they use these features only when required and recognise that greater levels of patient care and supervision will be required. It should be noted that the Tempus may be started in a low emitted light and silent state by using the Tactical switch on the right hand side of the device. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 39 Chapter 4 Setting up Tempus Pro Tactical Switch symbol the Tempus will start in the following configuration:

When the switch is set closest to the All alarm LEDs off;

All audible signals off;

Wireless functions (if enabled by configuration) off;

Display set to mid brightness and standard contrast mode. In this condition, the following menu of display options will be shown:

Press here to turn alarm sounds back on Press here to turn on High Contrast Mode Press here to turn on individual wireless devices Press here to turn LEDs back on Press here to select the desired brightness Press here to confirm the audio and visual settings and close the dialog Tempus Pro Display Tactical Menu Note To toggle high contrast, press and hold the Display button for two seconds. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 40 4.3 Starting and stopping the Tempus Pro and selecting a patient Toggling the Tactical Switch will immediately return the display settings to their previous configuration i.e. display brightness, all LEDs active, alarms set to the default level and high contrast off. The Tactical Switch disables the ac power and charging LEDs; these are only re-enabled using this switch. The battery charge LEDs are not disabled using the Tactical Switch. Note Note Note 4.3.3 Setting the patient WARNING Ensure that you select the correct patient record. Records can be identified by patient name (last and first), ID number, or incident start time. If you are not sure if the record you wish to select is the correct one, then select new patient. Mixing different patients records could lead to confusion and misdiagnosis. When the Tempus is turned on, it will ask if it is monitoring a new or previous patient. If the Select Previous Patient option is pressed, the Tempus will show all patients monitored in the last 72 hours i.e. any patients whose monitoring started within the last 72 hours. If any patients have been monitored in the last 72 hours, then the dialog will also include (shown below) an option to select the last patient that was monitored. Press here to confirm that the Tempus has been put onto a new patient Press here to confirm that the same patient as before is being monitored Press here to switch to a previously monitored patient Patient type is defined as Adult, Child (paediatric) or Neonate. For more information on these groups and how to select them, see 9.3.5 Entering patient details. 4.3.4 Starting and stopping iAssist The iAssist function gives additional on screen instructions for:

Using the ECG Taking non-invasive blood pressure readings Taking blood oxygen readings Taking C02 readings Taking temperature readings Tempus Pro User/Operator Manual - 41-2001EN-00 Page 41 Chapter 4 Setting up To switch it on or off:

1. Press the Main Menu button

. 2. Slide the iAssist switch to On or Off. When switched on, iAssist buttons appear at the bottom of the home screen. 4.3.5 Switching off Before switching the Tempus Pro off, you should make sure that it is not in use. To power off quickly with no countdown or confirmation:

1. Ensure the Tempus Pro is not in use. 2. Press and hold the button for 2 seconds. To power off with countdown and confirmation:

1. Ensure the Tempus Pro is not in use. 2. Press and release the button. The LED on the on/off button will start flashing. 3. The Tempus Pro displays a 10 second countdown timer. Press the Confirm Power Off button. The dialog shows a 10 second countdown before power off is aborted. To confirm power off, press here within 10 seconds. Power Off Dialog Before removing the battery, you must switch off the Tempus Pro by pressing the power button. Do not remove the battery when the Tempus is on (unless there is a power supply attached to the device). If necessary, you can force a hard shut-down by pressing and holding the power button for 10 seconds. Remember that the battery cannot be removed until the lamp on the front panel has gone out. Note Note Note Tempus Pro User/Operator Manual - 41-2001EN-00 Page 42 5 Using the Tempus Pro The Tempus can be used laying on its back or standing on its foot. 5.1 Controlling the Tempus Pro Touchscreen Membrane buttons Tempus Controls The Tempus can be controlled through two different control interfaces. These are:

The touchscreen;

The graphically labelled membrane buttons. 5.1.1 The touchscreen Note Take care to press the touchscreen once for any control. Users should press the controls firmly with a finger (gloved or bare skin can be used). Pressing the touchscreen lightly can lead to double presses if the users finger wavers or quivers. If the touch screen is pressed twice in quick succession and there is a control in the same area where the finger pressed after the first control would have disappeared (if the screen changes etc.) then the Tempus will register the second press as activating the second control before the control appears. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 43 Chapter 5 Using the Tempus Pro When the device is started it will present as follows:

4 parameter channels are provided. These are labelled and colour coded to the patient connectors on the side No patient sensors have been connected yet so this is indicated for each parameter Vital signs readings are displayed in these areas alongside alarm limits (if applicable) Each parameter area is a button which can be pressed to access the settings for that parameter The Home Screen at Start up Pressing any of the parameter areas will access the controls and settings menu for that parameter. For example, if the ECG area is touched, the following menu will be shown:

The current measurement is always shown here The parameter alarms can be turned off and on here All alarm settings can be accessed here Graphical and tabular trends can be accessed here Press here to return to the results screen Real-time vital signs are shown across the bottom ECG Settings Menu 1 of 2 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 44 5.1.2 Membrane buttons and LED indicators The Tempus can be controlled through the following membrane buttons:

5.1 Controlling the Tempus Pro The On/Off button pressing and holding down this starts and stops the Tempus see 4.3.1 Switching on. The Alarm Suspend button pressing this latches all alarms off for 2 minutes (factory default this is configurable by the operating institution) see 7.6 Silencing or suspending alarms. The Alarm Silence button pressing this stops any audible alarm signals for 2 minutes (factory default this is configurable by the operating institution) from monitoring parameters (and clears alarm signals from discrete measurements such as non-invasive blood pressure see 7.6 Silencing or suspending alarms. The Home button - this returns the unit to the results screen The Data Input/Output button pressing this launches a menu which offers options on outputting data to peripherals such as printers or USB memory sticks see 9.1 Data input and output. Note that pressing and holding the Data Input/Output button for 2 seconds will automatically launch the function that is shown at the top of the Data Input / Output menu. This acts as a short cut to make activating this function easier. The Display button pressing this launches a menu which offers a range of display options see 9.2 Display options. Note that pressing and holding the Display button for 2 seconds will automatically switch the display mode into a high contrast mode (black on white) for use in strong daylight conditions. This acts as a short cut to make activating the high contrast display easier. The Patient button pressing this allows the user to manage the patient information see 9.3 Patient information. Note that pressing and holding the Patient Information button for 2 seconds will automatically launch the function that is shown at the top of the Patient Information menu. This acts as a short cut to make activating this function easier. The Connect button pressing this will bring up instructions on how to connect the device to a Response Centre to transmit voice, data and images in real time see 9.6 Connecting to an alternate location. The Disconnect button if the device is connected to a Response Centre (i2i ReachBak only), pressing this will bring up a 10 second countdown after which the voice and data connection will be dropped see 9.6 Connecting to an alternate location. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 45 Chapter 5 Using the Tempus Pro The Camera & Waveform Snapshot button pressing and releasing this starts the waveform capture, pressing and holding will start the camera see 8 Summary Record of Care. Note that certain events will cause the Tempus to capture a waveform automatically see 8.1.4 Automatic event capture. Note for devices with software revisions earlier than v4 this button will only perform the camera function. Please contact RDT for software updates. The Main Menu button pressing and releasing this will take you to a full menu to access all features of the product see 5.2.1 The main menu. The Event button brings up the Summary Record of Care (SRoC) and provides access to trend graphs, trend tables and the TCCC card (if configured). The Previous Activity button pressing this will take you back to whatever non-

monitoring function you were last performing. For example, this button could be pressed to take you back into the trauma card if you had been editing it and a patient alarm had gone off see 3.3.10 Previous activity button. The battery gas gauge button pressing this will light the power status LEDs on the battery see 11.1.1 The battery. Also on the membrane are two LEDs, these are indicators and not a button, their function is described below:

Mains power LED lights solid green when the mains charger is attached Battery charger LED flashes green for up to 20 seconds when a battery is first connected and the device is being run from mains power, then lights solid green as long as mains power is attached and the battery is not fully charged see 11.1.3 Charging the battery. 5.1.3 Status bar The status bar at the top of the screen shows the time, battery status, communications status and alarms status see 7 Alarms. The current patient name and patient type appears in the centre of the status bar until any wired or wireless communications devices are being used then this will be shown in the centre of the status bar. The time and battery status are shown on the left This area is used to display information related to sending the Summary Record of Care report, connection status including connection to the Response Centre and the patient name / patient type. Alarm status information is shown on the right The Status Bar Tempus Pro User/Operator Manual - 41-2001EN-00 Page 46 5.1 Controlling the Tempus Pro Battery status indicator The battery status indicator in the status bar shows the percentage of battery charge remaining:

Icon Status Indication/Action Green, no flash Tempus Pro battery is not currently charging. Battery charge remaining: 51% - 100%. Green with flash Tempus connected to mains power (charging in progress). Battery charge remaining: 51% - 100%. Orange, no flash Tempus Pro battery is not currently charging. Battery charge remaining: 26-50%. Orange with flash Tempus connected to mains power (charging in progress)... Battery charge remaining: 26-50%. Red, no flash Battery charge remaining: 0% - 25%. Tempus Pro battery is not currently charging: connect it immediately!

Battery charge remaining: 0% - 25%. Red with flash Tempus connected to mains power (charging in progress). Tempus cannot communicate with battery. Check the following:

Unknown battery status Is the battery fitted?

Are the battery clips fully engaged?

Are the battery contacts clean and undamaged?

Is the battery in deep discharge state?

For more information, see 11.1.1 The battery. The battery charge can always be checked by pressing the battery gas gauge button, even when the Tempus is switched off see 11.1.1 Checking the charge of the battery. Note Tempus Pro User/Operator Manual - 41-2001EN-00 Page 47 Chapter 5 Using the Tempus Pro 5.1.4 Status bar for communications The centre section of the status bar shows if any communications features are being used. If any Bluetooth devices are in use, then the Bluetooth symbol will be shown and along with the number of peripherals that are connected to the device. Note It does not identify the specific peripheral connected to the Tempus Pro. If a WiFi connection is in use, then this will be shown. If an external Invasive Pressure module is attached, then this will be shown. The information displayed in the communications area of the status bar is based on the following priorities:

Email highest priority Response Centre communication Patient name & type lowest priority Email status bar messages When the Summary Record of Care is being shared using email, the upper part of the status area is used to display the connection progress whilst the lower part of the status area is used to indicate the progress related to the Summary Record of Care report creation and sending. The connection progress messages (upper part) may be:

Network Connecting

<Carrier name> e.g. Vodafone UK (only in GSM mode) Network Connected (only in Wi-Fi or Ethernet modes) The SRoC report progress messages (lower part) may be:

Creating Report Sending Report Report Sent (displayed for 30 seconds after completion) In this example, an Ethernet connection has been made and the SRoC report is being created Status bar when SRoC report is shared via email Messages Tempus Pro User/Operator Manual - 41-2001EN-00 Page 48 5.1 Controlling the Tempus Pro Response Centre (i2i) communication If a data connection is in progress this will be shown. The green icon will flash when the connection is in being established and the text will read Data connecting. When a link to the data centre (gateway) has been made the icon will stop flashing and the text will read Data connected. At this time the Tempus will be connected to the data centre (gateway) but will not be transmitting any patient data until a Response Centre user initiates the connection from their terminal. Once they have done this the text will read Data Connected. Note To transmit data, you must have a manned Response Centre who have the i2i software installed and who have familiarised themselves with its operation. Full installation instructions are provided with the i2i software and support is available from RDT, see RDT contact details. If a voice connection has been initiated, then an additional green icon will appear with the text Voice next to it. The icon will flash while the voice connection is being established and will stop flashing once the call has been picked up by the Response Centre. If video is being transmitted this will be shown. This section shows if Bluetooth devices are attached (and how many), if video is being transmitted and if WiFi is being used This section shows if data is connecting (dialling), connected

(connected to a data centre/gateway) or Connected (connected to a Response Centre) This section shows if voice is connecting (the icon will flash) or connected (the icon will be solid) Status bar when response centre communication is established 5.1.5 Instrument readings When the Tempus is in use each area will become populated with data. For ECG, Pulse Oximetry, Contact Temperature, Invasive Pressure or Capnography the data will begin to appear on the display as soon as the parameter is connected i.e. there is no start control or button for these parameters. Since the non-invasive blood pressure measurements are single readings this requires the user to both attach the cuff to the patient and start the reading. These readings are therefore time-stamped with the time that they were recorded. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 49 Chapter 5 Using the Tempus Pro 5.2 Menus 5.2.1 The main menu If ever you are unsure of what to do, press one of the following membrane buttons:

At the top of the screen is status information Labelled buttons are provided to access menus and features The Main Menu button - this will take you to a full menu to access all features of the product. The Home button - this returns the unit to the results screen. The menu is spread over four pages, you can scroll through these by pressing the up and down arrow The All Alarms button opens a single menu where all alarms can be viewed The Trends button accesses trend data The Back button takes you back to the Home screen or to the previous menu you were in Structure of the Main Menu CAUTION The Quick Start Guide is intended to provide field-based users with summary information only. It does not replace the need to read this Users Manual or any other device labelling and does not replace proper training on the device. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 50 The Main Menu allows access to the following features and controls:

Menu option Menu screen 5.2 Menus TDL Settings for use with the Tempus ALS system. Quick Start Guide pressing each numbered button will take you through a series of graphics which explain the features of the device. Medical Parameter Settings open a menu from which all medical parameter settings can be accessed, see 6 Taking medical readings. Summary Record of Care - performs the same function as the Event membrane button, see 3.3.9 Summary Record of Care /

Tactical Combat Casualty Care. Waveform Snapshot - performs the same function as pressing and releasing the membrane button, see 5.1.2 Membrane buttons. Display Menu performs the same function as the membrane button, see 9.2 Display options. Patient Menu performs the same function as the membrane button, see 9.3 Patient information. Data Input / Output Menu performs the same function as the membrane button, see 9.1 Data input and output. Previous Activity - performs the same function as the membrane button, see 3.3.10 Previous activity button. Camera performs the same function as pressing and holding the membrane button, see 9.4 Digital camera. Home performs the same function as the membrane button. IAssist turn iAssist on or off, see 9.7 iAssist processes. Note: The All Alarms and Trends buttons are present on all pages of the Main Menu, see:

7 Alarms 8 Summary Record of Care Note: Switches are provided to turn functions on and off, e.g. iAssist here. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 51 Chapter 5 Using the Tempus Pro Menu option Menu screen Communication Modes configure the modes, see 9.6.4 Communications modes. Wireless Enabled disable or enable all wireless communications. If any of these features are not enabled (either not purchased or disabled in the devices maintenance settings) then they will be greyed out. Connect performs the same function as the membrane button, see 9.6 Connecting to an alternate location. Manage Wi-Fi Networks provides access to the Manage Wi-Fi Networks menu. GPS Location obtain a fix on the devices location (using the built-in GPS module), see 9.5 GPS location. Power and Clock Settings provides access to screen brightness, time, date and power saving settings, see 5.2.3 Power and clock settings. Maintenance and Settings open the Maintenance and Setting Menu. This allows unit name and mode network settings to be modified, see the Tempus Pro Maintenance Manual (available from RDT). Demonstration and Training review and update the demonstration settings, see 13.1 Demonstration and training. About Tempus Pro view device identification data and a list of features installed on Tempus Pro, see 9.8 View installed features. Printer and Headset open the settings for the communications interfaces of the product, see 5.2.2 Printer and Headset menu. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 52 5.2 Menus 5.2.2 Printer and Headset menu The current unit configuration can be viewed by accessing the Configuration screen from the Printer and Headset menu see 5.2.1 The main menu. The Printer and Headset menu allows access to settings and controls that the user may occasionally need to access. Note that the primary communication settings are designed only to be controlled by maintenance staff so these settings are only available behind the maintenance menu function in the main menu. The menu allows access to the following functions:

Menu option Menu screen Pairing Bluetooth provides step-by-step instructions on pairing the device. Headset Settings update the headsets noise filter setting (applicable only to the Bluetooth headset) and change the default headset between wired and wireless. External Printer Settings choose the default printer paper - either US Letter (8.5 x 11) or A4 - and switch between PCL3 &

PCL3-GUI printer types. Internal Printer Settings only available if the Tempus Pro is fitted with a printer. Change internal printer settings, for example paper type (plain or grid) and auto print snapshots (on or off). See 9.9 Printer maintenance. 5.2.3 Power and clock settings Using this menu, you can set the power save mode and the screen brightness level. For details relating to the brightness setting, see 9.2.5 Brightness control. This menu is accessed using the Power and Clock Settings button on the Main Menu see 5.2.1 The main menu. Menu option Menu screen Power save mode turn power saving on or off. Brightness select the screen brightness level. Note: The current time and date are also displayed. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 53 Chapter 5 Using the Tempus Pro Tempus Pro User/Operator Manual - 41-2001EN-00 Page 54 6 Taking medical readings Note When a medical module is first started the word initialising may appear for a few seconds in the results area associated to the medical parameter being started. 6.1 Electrocardiography (ECG) The Tempus Pro allows the user to either monitor the patients ECG or take a diagnostic recording of their ECG (this is an optional feature). This section will explain how to use both features. The device defaults to ECG monitoring with either a 3-lead, a 4-lead or a 5-lead cable. WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING The ECG device is not intended for use in a sterile environment. Do not use for direct cardiac application. The ECG device is reusable, other than disposable single-use electrodes. Do not attempt to insert the ECG device (including patient cables) into an electrical outlet. The ECG is for resting recordings and should not be used in stress testing environments. Ensure electrodes are connected only to the patient. Conductive parts of electrodes and connectors, including neutral electrode, should not contact other conductive parts including earth. During ECG recordings, ECG alarms are not active and will only be reactivated once monitoring is resumed. The Tempus Pro is rated as being proof against the effects of a defibrillator discharge. Follow these warnings if using an AED or defibrillator with the Tempus Pro:

Follow the instructions of the defibrillator or AED when using it with the Tempus Pro. Do not touch the patient during defibrillation. Do not touch the defibrillators paddle-electrode surface when discharging the defibrillator. Keep defibrillation electrodes well clear of other electrodes or metal parts in contact with the patient. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 55 Chapter 6 Taking medical readings Do not touch the patient, bed, or any conductive material in contact with the patient during defibrillation. The Tempus Pro is protected against defibrillator discharge but rate meters and displays may be temporarily affected during defibrillator discharge but will rapidly recover. The Tempus Pro may not operate effectively on patients who are experiencing convulsions or tremors, or who are moving or are in motion (transport) environments. In such cases remember to use best practise for electrode site selection (torso rather than limbs), site preparation (cleaning/scrubbing with an alcohol wipe) and cable securement at the sensor site and as much as possible along the cables length. In motion environments the Tempus should be secured using a clamp or strap and to obtain the best possible readings the device should be damped to reduce shocks or vibrations if possible. The Tempus is not for direct cardiac application. Do not use electrodes of dissimilar metals. Always set the Tempus Pro to the correct patient age to ensure the QRS detector is set to detect appropriate R wave amplitudes. Per AAMI EC 13, the Tempus uses the definitions of patient age provided as follows:

Neonate Children 28 days old or less if born at term (based on 37-week gestation), otherwise up to 44 gestational weeks. Paediatric (Child) Children of 29 days up to and including 12 years old. Adult Individuals 13 years old or older. Failure to set the correct age may result in the Tempus mis-detecting R waves and providing incorrect heart rate values. Setting the patient age to 8 years or less will mean that the ECG monitor will be set to detect paediatric R waves per AAMI EC13. If you do not set the patient age, the Tempus will use the default patient age group

(see the Tempus Pro Maintenance Manual). Ensure that the patient age/type is always entered for non-adult patients see 9.3.5 Entering patient details. WARNING WARNING WARNING WARNING WARNING CAUTION As the following sections will explain, the Tempus Pro will present results in a different layout depending on whether the device is set to ECG monitoring or Diagnostic ECG. The alarm functions will be the same in either case. CAUTION Certain line-isolation monitors may cause interference on the ECG display and may inhibit heart rate alarms. Users should ensure electrodes are placed correctly, with the skin prepared in advance as instructed. CAUTION The electrodes of the ECG apron must be applied carefully. Follow the electrode manufacturers instructions in the storage, removal and application of the electrodes to the patient to ensure the electrode is placed optimally. CAUTION Care must be taken to ensure that the electrodes do not contact live (electrical) parts or earthed metal parts of local systems or structures. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 56 6.1 Electrocardiography (ECG) CAUTION Note Note If the patient is attached to a cardiac defibrillator, care must be taken not to touch any part of the ECG cables while the patient is being shocked. The leads and cables of the ECG should be checked for fraying, tears, knots or other signs of damage before and after use. Ensure that all labelling including instructions for use, printed warnings and use-by dates associated with third-party ECG electrodes are adhered to. 6.1.1 Getting started 1. To measure correct R wave values, make sure that the right age group is selected in the patient details. For instructions, see 9.3.5 Entering patient details. 2. Make sure that you have read the monitoring standards in "14.1.1 ECG monitoring". 3. Ensure that the ECG cable is properly inserted into the green connector on the Tempus Pro:

4. Prepare the patient's skin at the electrode sites:

Shave or clip excess hair. Clean the skin thoroughly with an alcohol wipe. Rub the skin to dry. 5. If the patient has a pacemaker, turn on pacemaker indication:

Press the ECG area of the touchscreen or navigate to the medical parameter setting in the Main Menu. Switch Pacemaker indication on. 6. Make sure that the frequency setting matches the frequency of the mains you are using:

Press the ECG area of the touchscreen. Select the correct Mains power frequency. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 57 Chapter 6 Taking medical readings 6.1.2 Monitoring ECG with a 3-lead cable By default, the Tempus Pro will be set to ECG monitoring when it is supplied. ECG monitoring with a 3-lead cable allows the user to monitor Leads I, II or III of the patients ECG. ECG monitoring requires the use of a 3-lead/electrode cable see 12 Accessories list of the Tempus Pro. The 3-lead cable may be pre-attached to the Tempus in the green connector. The Tempus Pro will automatically detect which cable type is in use. With a 3 electrode cable one lead waveform (I, II, or III) is available for display at a time. Electrode Positions for 3-lead ECG Monitoring The cable terminates in conventional 4 mm snap connections which can be used with various commonly available disposable ECG electrodes. Two types of cables are provided for compliance with AAMI and IEC guidelines. For details of cable part numbers, see 12 Accessories list of the Tempus Pro. These are labelled:

Position AAMI Label/Colour IEC Label/Colour Right mid-clavicular line under clavicle / right wrist RA White Left mid-clavicular line under clavicle / left wrist LA Black Left hip / left ankle LL Red R Red L Yellow F Green Once the electrodes are connected to the patient, the Tempus will begin to display the ECG signals immediately. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 58 6.1 Electrocardiography (ECG) 6.1.3 Monitoring ECG with a 4-lead cable ECG monitoring with a 4-lead cable allows the user to monitor Leads I, II, III, AvL, AvR and AvF. Up to two leads can be displayed at any time. Four wire ECG monitoring requires the use of a 4-lead/electrode cable see 12 Accessories list of the Tempus Pro. The 4-lead cable should be pre-attached to the Tempus in the green connector. Electrode Positions for 4-lead ECG Monitoring (torso or limbs) The cable terminates in conventional 4 mm snap connections which can be used with various commonly available disposable ECG electrodes. Two types of cables are provided for compliance with AAMI and IEC guidelines. For details of cable part numbers, see 12 Accessories list of the Tempus Pro. These are labelled:

Position Right mid-clavicular line under clavicle / right wrist Left mid-clavicular line under clavicle / left wrist Left hip / left ankle Right hip / right ankle AAMI Label/Colour IEC Label/Colour RA White LA Black LL Red RL Green R Red L Yellow F Green N Black If the ECG is inoperable then the ECG will either show a Leads off error for the specific Lead that is unavailable or will show a technical error as described in section 7.4 Technical alarms. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 59 Chapter 6 Taking medical readings 6.1.4 Monitoring ECG with a 5-lead cable ECG monitoring with a 5-lead cable allows the user to monitor Leads I, II, III, AvL, AvR, AvF or a user-

placeable V Lead. Up to two leads can be displayed at any time. Five wire ECG monitoring requires the use of a 5-lead/electrode cable see 12 Accessories list of the Tempus Pro. The 5-lead cable should be pre-attached to the Tempus in the green connector. Electrode Positions for 5-lead ECG Monitoring The cable terminates in conventional 4 mm snap connections which can be used with various commonly available disposable ECG electrodes. Two types of cables are provided for compliance with AAMI and IEC guidelines. For details of cable part numbers, see 12 Accessories list of the Tempus Pro. AAMI Label/Colour IEC Label/Colour RA White LA Black LL Red RL Green V Brown R Red L Yellow F Green N Black C White These are labelled:

Position Right mid-clavicular line under clavicle / right wrist Left mid-clavicular line under clavicle / left wrist Left hip / left ankle Right hip / right ankle This is a moveable pre-cordial electrode. Place it in any position from V1-6 as follows:

V1 - 4th intercostal space at right sternal margin. V2 - 4th intercostal space at left sternal margin. V3 - Midway between V2 and V4 leads. V4 - 5th intercostal space at mid-clavicular line. V5 - Same transverse level as V4 at left anterior-axillary line. V6 - Same transverse level as V4 at left mid-axillary line. If the ECG is inoperable then the ECG will either show a Leads off error for the specific Lead that is unavailable or will show a technical error as described in section 7.4 Technical alarms. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 60 The picture below shows the Tempus monitoring Lead II and Lead I (using a 5-lead cable). Each ECG trace is labelled in the top left. The heart rate is shown on the right hand side for the uppermost trace. 6.1 Electrocardiography (ECG) Tempus monitoring Lead II and Lead I (using a 5-lead cable) Selected 6.1.5 Monitoring ECG with a 12-lead cable Diagnostic 12 lead ECG is an option on the Tempus Pro. You can use a standard 12-lead ECG cable or a 12-lead modular cable (a 4-lead cable connected to an additional 6-lead cable). The cable terminates in a 4 mm snap style connector for use with normal disposable electrodes see 12 Accessories list of the Tempus Pro. To view a 12-lead ECG, the ECG settings must be changed as shown below. With the 12 Lead cable connected, press here to activate the 12 Lead view ECG Settings Menu 12 Lead ECG Selected If the 12-lead ECG Cable is attached but the 12-lead View is not selected on the screen, then the Tempus will remain in standard ECG monitoring mode and will continue to show two waveforms on screen. Two types of cables are provided for compliance with AAMI and IEC guidelines. For details of part numbers of cables, see 12 Accessories list of the Tempus Pro. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 61 Chapter 6 Taking medical readings These are labelled:

Position AAMI Label/Colour IEC Label/Colour Right mid-clavicular line under clavicle / right wrist Left mid-clavicular line under clavicle / left wrist Left hip / left ankle Right hip / right ankle RA White LA Black LL Red RL Green This is a moveable pre-cordial electrode. Place it in any position from V1-6 as follows:

V1 - 4th intercostal space at right sternal margin. V2 - 4th intercostal space at left sternal margin. V3 - Midway between V2 and V4 leads. V4 - 5th intercostal space at mid-clavicular line. V5 - Same transverse level as V4 at left anterior-axillary line. V1 Red V2 Yellow V3 Green V4 Blue V5 Orange R Red L Yellow F Green N Black C1 Red C2 Yellow C3 Green C4 Brown C5 Black V6 - Same transverse level as V4 at left mid-axillary line. V6 Violet C6 Violet The electrodes should be attached to the patient as shown below. Before attachment the patients skin should be prepared according to the instructions of the electrodes e.g. cleaning the skin with alcohol and shaving if necessary. Remember only to use electrodes which are compliant with AAMI EC12 and to read and follow the instructions for the electrodes. Electrode Placement for 12 Lead ECG Monitoring Once in 12 Lead ECG Mode, the ECG will monitor 12 Leads of ECG. If the ECG is inoperable then the ECG will either show a Leads off error for the specific lead that is unavailable or will show a technical error as described in section 7.4. WARNING When acquiring a 12-Lead ECG, encourage the patient to remain as still as possible. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 62 In 12 Lead mode, the other vital signs data remain displayed across the bottom of the display. All 12 ECG Leads are shown in the main display (each Lead is labelled). 6.1 Electrocardiography (ECG) The Tempus will remain monitoring the 12 leads until a 10 second recording is started by pressing this Press here to view previous recordings 12 Lead ECG Monitoring Screen The real time vital signs are displayed here If no signal or a poor signal is seen on one or more leads, the following steps should be reviewed:

Is the patient still?

Is the equipment setup properly (all electrodes attached)?

Has the correct cable been used, is it connected properly?

Could there be interference from other electrical equipment?

Are the 12 lead filters set correctly (see ECG Settings)?

Was skin sufficiently well prepared?

Could the electrodes be dry or poorly attached?

Is the mains filter set correctly (see ECG Settings)?

6.1.6 Performing a diagnostic ECG The 12 Lead function enables users to record a 10 second trace for immediate or subsequent analysis and interpretation. The 10 second recording will be added to the patient record and therefore can be exported by USB stick to another Tempus or to a computer to be read as a .PDF file. The ECG can also be transmitted to a Response Centre if this option is in use see 9.6 Connecting to an alternate location. Making a 12 lead ECG recording Pressing the Start Record button will initiate a 10 second recording. If the Tempus is connected to a Response Centre then this will be transmitted as soon as the recording is complete. The Response Centre has tools for measuring the ECG. Otherwise, the recording can be viewed on screen by using the left and right arrow keys. Note If you inadvertently press Stop Record, you can press Start Record to immediately restart the recording. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 63 Chapter 6 Taking medical readings 12 Lead ECG Recording Screen The ECG recording can be scrolled through using these buttons If an internal printer is fitted to the Tempus, you can print the 10 second recording using the Print button. For printer instructions see 9.9.2 Internal printer configuration (optional). If the Tempus Pro is fitted with an internal printer and automatic printing is enabled, it will print waveforms as soon as they are captured. ECG interpretation WARNING WARNING WARNING Note Note All numerical, graphical and interpretive data should be evaluated with respect to the patient's clinical and historical picture. ECG interpretation performed by software is not a substitute for review and evaluation of ECG recordings by a qualified clinician. Motion artefact or noise in the ECG recording could result in erroneous interpretations. Interpretations are unconfirmed and need to be reviewed by a clinician. ECG interpretation is only available for patients aged 18 years and over. If age is not set, interpretation will be based on an adult patient type. The Tempus Pro provides ECG interpretation of the 12 lead ECG recordings. This interpretation includes:

Rhythm statements there are 69 different statements this includes the reporting of detected Arrhythmias such as Ventricular Tachycardia, Atrial Fibrillation, Extreme Bradycardia, and AV Block

(please see QRS Diagnostic Physician's Guide ECG Analysis for Resting 12-lead ECG for further information, Part number 630000-00). Morphology statements there are 121 different statements including ST analysis which includes over 20 Ischemic ST change statements such as: Ischemic ST-T changes in posterolateral leads and Tempus Pro User/Operator Manual - 41-2001EN-00 Page 64 6.1 Electrocardiography (ECG) Ischemic ST-T changes in lateral leads (please see QRS Diagnostic Physician's Guide ECG Analysis for Resting 12-lead ECG for further information, Part number 630000-00). Waveform summary measurements this includes; QT and QTc interval measurements, PR interval, QRS duration, P duration, P axis, QRS axis and T axis. Once a 12 lead ECG has been recorded you can view the ECG interpretation. Press here to cycle through all ECG recordings Press here to view the Interpretation Press here to start monitoring the 12 lead ECG Press here to see the ECG recording Press here to see the summary page View ECG Recordings Screen ECG Interpretation Screen Tempus Pro User/Operator Manual - 41-2001EN-00 Page 65 Chapter 6 Taking medical readings Press here to go to the ECG Interpretation page Press here to start monitoring the 12 lead ECG Press here to see the ECG recording ECG Summary Screen 6.1.7 ECG specifications ECG monitoring specifications The following disclosures are made in accordance with the requirements of AAMI EC13 and IEC60601-2-27:

The ECGs display includes the isoelectric segments of the QRS. For leads off detection, the ECG device applies a 1 kHz triangular wave of approximately 6 mV p-p between the R/RL and L/LL electrodes The Heart Rate Detection of the ECG monitor is accurate to +/-10% or +/-5 bpm for a T Wave of amplitude: up to 1.0 mV. The heart rate is calculated from the average of the 8 most recent RR intervals. Intervals are logged as invalid if the detections are unreliable, or if detections are absent over the maximum RR interval of 2.4 s. Invalid intervals are counted but not included in the average. If there are no valid intervals in the most recent 8, then no heart rate is reported. Heart rate is updated with every new valid or invalid interval. Further to clause 4.1.2.1e) of AAMI EC13: the systems response to Fig 3a is 40 bpm 10% (inverted QRS are counted). The systems response to Fig 3b is 30-100 bpm (small QRS are intermittently counted). The systems response to Fig 3c is 120 bpm 10% (all QRS are counted). The systems response to Fig 3d is 60-100 bpm (bipolar QRS are intermittently counted). Electrical noise such as power line transients can cause false heart beat detection which may inhibit alarms. The problem may be minimized by ensuring good electrode contact. Power system noise may be reduced by running the monitor from its battery. The systems typical response time to change from 80 to 120 bpm is ~7 s, for a change from 80 to 40 bpm is the typical response time is ~7.5 s. The system heart rate alarm will respond to the specified tachycardia signals of Figures 4a and 4b of AAMI EC13 within 5-7 s. In some cases, an out of range alarm may be given, with an indication of no valid heart rate. The heart rate limit alarm will respond to an out of range condition 0-10 seconds after being activated. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 66 6.1 Electrocardiography (ECG) Per EC13, 4.1.4.1, heart rate is accurately indicated in the presence of effective pacemaker single pulses without overshoot, having width of up to 2 ms and amplitude up to 700 mV, and such pulses alone do not cause heart rate detection. In the case of ineffectively paced QRS, erratic readings may result for single pulses above 2 mV. Overshoot is specified according to EC13 4.1.4.1 Method B. Per EC13 4.2.9.12, the muscle filter will make pacemaker pulses appear smaller than 2mm. Switch muscle filters off (Diagnostic filter setting) to see pacemaker pulses more clearly. Measurements of the ECG waveform should be normalized against the scale provided. The scale presents 1 mV as 8 mm with a gain setting of 10mm/mV. Note that in the 4 waveform view the channel height of the ECG is 24 mm and thus permits a maximum input signal of 2.2 mV when using a gain of 5 mm/mV. In the large ECG view a maximum input signal of 5 mV is achieved using a gain of 5 mm/mV. Large ECG view is described in 9.2 Display options. Compliance with EC12 clause 4.2.9.8 b) (and relevant clause of IEC60601-2-25:2011) requirements for frequency response are achieved only with the muscle filters switched off (i.e. using the Diagnostic filter setting). For leads off detection, the ECG applies a 1 kHz triangular wave of approximately 6 mV p-p between the R/RL and L/LL electrodes. The slew rate of the ECG as per AAMI EC13 4.1.4.3 is 3.7 V/s (all filters off). ECG recording specifications The following disclosures are made in accordance with the requirements of AAMI EC11 and IEC60601-2-25:

Frequency and impulse response has been evaluated according to methods A, B and C of EC11:1991 3.2.7.2/4.2.7.2. All EC11 tests have been performed using SCP files generated by the i2i software as an acquisition system. Compliance requires that all optional filters be switched off. ECG data in this system are contained in computer files, using a proprietary format based on the SCP-

ECG standard. The ECG data are digitized using a sample rate of 500sps and a resolution of 2995nV/bit with 12 bit (4096 level) dynamic range. Automated measurements of amplitude and duration of QRS complexes generated from the ECG recording are only valid for adult patients. For younger patients the values should be measured using the electronic calipers within i2i. Per clause 201.12.1.101.3 automated measurements of the S segment duration of CAL waveforms are 15 ms. The automated value can be confirmed using the electronic calipers within i2i Per clause 201.12.4.107.3 The skew rate is 0 Automated measurements are only able to distinguish T-waves of amplitudes greater than >50 V Tempus Pro User/Operator Manual - 41-2001EN-00 Page 67 Chapter 6 Taking medical readings 6.1.8 ECG settings Pressing either of the ECG trace areas will bring up the ECG settings menu:

Menu option Menu screen Heart rate limits (bpm) open the the alarm limits editor (described below). Heart Rate Lead (4-, 5- and 12-lead ECG only) change which lead the heart rate is taken from. Waveform / Lead selection - when using 4-, 5- or 12-lead ECG, press here to customise the selection of waveforms on the four waveform display, see 9.2.4 Waveform and lead selection. HR/PR source select ECG or Pulse oximeter as the heart/pulse rate source (see also HR/PR beat volume below). ECG Gain (mm/mv) select the desired gain

(or size) of the waveform. View 12 lead ECG if the 10 wire (12 Lead) ECG cable is selected, this option will be available. Pressing it will bring up a different display interface that shows all 12 ECG leads. Arrhythmia analysis and ST/QT analysis

(on/off) enable or disable these measurements. ST lead selection - when ST monitoring is active, change the ST leads that are displayed, see ST lead selection. ST1 limits (mm) open the editor to change the ST alarm limits. ST2 limits (mm) open the editor to change the ST alarm limits. QT upper limit (ms) open the editor to change the QT alarm upper limit. Cardiac wave speed (mm/s) select the desired speed of the waveform. Note: When using a 3-lead ECG, the heart rate is derived from the waveform displayed:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 68 Menu option Menu screen 6.1 Electrocardiography (ECG) HR/PR beat volume volume of the audible tone that the Tempus emits every time a heartbeat is detected. Use the up and down arrows to adjust the volume from zero (no tone) to 100%. The tone is based on the HR/PR source setting (see above): when set to ECG, QRS beats trigger a single tone at 1 kHz. When set to Pulse, pulse beats trigger pulse tones see 6.3.6 Pulse oximeter settings. Pacemaker indication turning this on will show a vertical dotted line on the ECG waveform when the ECG is connected to a patient wearing a pacemaker. Monitoring filter use the arrows to select a filtering option. 12 lead filter use the arrows to select a filtering option. ECG Power Filter this is set to ON by default, switch it off if you wish the ECG to be presented without the Power noise being filtered out. ST lead selection screen First press ST1 or ST2 ST Lead Selection Then select the lead you wish to be displayed e.g. Lead III Lastly press on Cancel to clear the changes or Save & Back to keep them, either option will return to the ECG settings menu Note The ECG waveforms displayed on the home screen will change to match the selected ST leads. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 69 Chapter 6 Taking medical readings In order to reduce noise and artefact the Monitoring filter should be set to Monitor or Filtered diagnostic and the Mains filter should be switched on. When attached to a mains power supply noise may be observed on the ECG if these filters are switched off. Consequently, they should be left switched on when operating under mains power or mains power should be disconnected if the filters need to be switched off. Users are reminded to have the mains filter frequency set to the correct value (50 Hz or 60 Hz) in order for it to be effective. This should be checked before use. Note Note Mains frequency setting. Hz means Hertz, or cycles per second. In North America, mains electricity supplies operate at 60 Hz; most of the rest of the world uses 50 Hz. In aircraft the filter should normally be set to 50 Hz. In remote land and maritime applications, the local voltage could be either 50 Hz or 60 Hz. ECG systems can pick up interference from mains electricity supplies. This interference appears on the screen as regular interference patterns. 6.1.9 Detecting arrhythmias during ECG monitoring During ECG monitoring, the Tempus Pro analyses the 2 ECG waveforms on the home screen to detect arrhythmias. All results are displayed as text on the results screen. WARNING WARNING WARNING WARNING ECG monitoring arrhythmia analysis is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times. The Automated ECG Arrhythmia Analysis software is designed to be used by qualified medical personnel. The clinician and/or medically qualified personnel are responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia detection feature on the Tempus Pro is not a diagnosis tool and is an additional tool to support the clinician in their own diagnosis only. The classification performance of the arrhythmia feature has been tested using the FDA recognised consensus standard. The analysis algorithm has also been tested and approved in other products. The monitor cannot be relied upon to detect all arrhythmias. Do not rely solely on the displayed arrhythmia data and alarms to assess the patients condition. Always observe the patient closely and monitor all of their vital signs carefully. WARNING The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial or supraventricular arrhythmias. The program may incorrectly identify the presence or absence of an arrhythmia. A physician must analyse the arrhythmia information with other clinical findings. WARNING The system can filter out some interference but corrupted or excessively noisy signals may cause artefacts. If the ECG waveform is too noisy, Noise is displayed on screen. If no arrhythmias are detected and there is no noise in the signal, Arrhythmia Analysis On is displayed to ensure the operator is aware arrhythmia analysis is running. WARNING Heart parameters can be affected by the use of drugs. Patient drug use history should be reviewed when reviewing detected arrhythmia. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 70 6.1 Electrocardiography (ECG) For patients with pacemakers, ensure pacemaker indication is turned on. Arrhythmia analysis is sourced from the ECG signal (including detection of extreme bradycardia, extreme tachycardia), this is independent of the heart rate display source selection (ECG or pulse). Only start arrhythmia learning during periods of predominantly normal rhythm, and when the ECG signal is relatively noise-free. If arrhythmia learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent arrhythmias. If arrhythmia analysis is not restarted when a template changes:

Inaccurate arrhythmia alarms can be triggered. Inaccurate heart rates can be recorded. WARNING WARNING CAUTION CAUTION To optimise arrhythmia detection, select leads with the largest amplitude and the least amount of noise to be analysed:

1. Turn on arrhythmia analysis in the ECG menu. Arrhythmia detection starts up and performs a learning period. 2. To change the waveforms being analysed, press Lead waveform selection on the ECG menu and select the lead required. 3. If a patient's ECG template changes dramatically, turn arrhythmia analysis off and on. Arrhythmia detection performs a relearning period based on the new template. An arrhythmia detection relearning period can also be triggered when you:

Change patients Change Lead waveform selection or Heart rate lead options The following arrhythmia events are detected and recorded:

Arrhythmia Screen Description text High priority patient alarm triggered Event /

waveform capture Extreme Extreme bradycardia Brady Extreme Extreme tachycardia Tachy Ventricular Vent tachycardia Tachy Asystole Asystole The average heart rate is 5 bpm below the low heart rate set on the Tempus Pro (with a maximum of 60 bpm). The atrial and ventricular rates are equal. The heart rate is 5 bpm above the high heart rate limit set on the Tempus Pro (with a minimum of 100 bpm) Ventricular HR is greater or equal to the Tachycardia rate threshold and the number of PVCs is greater than 6. No QRS complex for 5 consecutive seconds (in absence of ventricular fibrillation or chaotic signals) Ventricular Vent Fib fibrillation Ventricular fibrillation occurs and persists for more than 6 seconds. A medium priority alarm is triggered when:

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Tempus Pro User/Operator Manual - 41-2001EN-00 Page 71 Chapter 6 Taking medical readings Arrhythmia analysis is turned off, and either the low heart rate or high heart rate alarm limits are breached. Arrhythmia analysis is turned on, and either the low heart rate or high heart rate alarm limits are breached A high priority Extreme Brady or Extreme Tachy alarm is triggered when the heart rate continues past already breached alarm limits. A 20 second waveform snapshot is captured for all arrhythmia events that trigger an alarm see 8.1 Event capture. 6.1.10 Measuring ST elevation and QT interval (optional) WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING ST measurements should always be verified by the clinician and/ or medically qualified personnel. Some clinical conditions may make it difficult to achieve reliable ST monitoring. For best results, consider the following: the ability of the patient to cooperate and be relaxed. Patients who are restless can produce noisy physiological signals. Noisy signals which can result in inaccurately high or low data measurements. QT measurements should always be verified by the clinician and/ or medically qualified personnel. The ST and QT measurements have not been qualified for use on paediatric or neonate patients and are therefore switched off when an age <18 is entered on the Tempus Pro. The QT algorithm has been tested for accuracy. The significance of the QT segment however needs to be determined by a clinician. This feature is to aid the clinician in monitoring the change in QT only. The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes however needs to be determined by a clinician. This feature is to aid the clinician in monitoring the change in ST and not diagnosing STEMI or Ischemic events. During the 10 seconds of an ECG recording ST and QT measurements will stop and therefore there may be an additional delay before an ST or QT alarm is triggered if the alarm limit is breached during a recording. For very high heart rates (>250 bpm) no ST value will be reported. Some arrhythmia conditions may make it difficult to reliably produce ST measurements. With ECG waveforms with T-waves smaller than 0.1 mV, the accuracy of the QT measurement may be reduced, therefore select leads with large T-waves. Note When using a 3-lead ECG cable only 1 ECG waveform is produced. Therefore, only 1 ST measurement value can be produced by the Tempus Pro. For optimum monitoring of ST, a 4- or more lead cable should be used so both ST measurements can be reported. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 72 6.1 Electrocardiography (ECG) The Tempus Pro presents the user ST elevation (+) and depression (-) measurements as well as QT duration measurements for the electrocardiogram (ECG) monitoring waveform and displays it in numeric format on the results screen. The Tempus makes ST and QT measurements on the 2 waveforms which are viewed on the home screen. These waveforms can be changed using the Lead Waveform selection option on the ECG menu. These measurements can be performed on any of the lead types available from the ECG cable being used. An ST measurement for each of the 2 waveforms is reported along with a single global QT measurement value. The ST measurement is taken between the ECG isoelectric line (PR segment) and a point in the ST segment. The point taken for measurement is 80 milliseconds after the J point if the heart rate does not exceed 115 bpm and 60 milliseconds after the J point if the heart rate exceeds 115 bpm. The ST measurement value is updated every 10s. If the measurement is not available, the display will show - - - . The ST value measured is a voltage; by convention the value is displayed as the equivalent measurement height for a standard ECG gain of 10mm/mV. In this convention 0.1mV will be displayed as 1.0mm. The ST measurement height gain is fixed at 10mm/mV and does not depend on the ECG gain setting. A medium priority alarm will be triggered if the ST alarm limit is exceeded for more than 1 minute and the value will flash to indicate it is in alarm. The QT interval is a measurement of the time between the start of the Q wave and the end of the T wave in the hearts electrical cycle. The Tempus Pro shows this measurement on the results screen. The QT value is reported in milliseconds (ms). A medium priority alarm will be triggered if the QT alarm limit is exceeded for more than 1 minute and the value will flash to indicate it is in alarm. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 73 Chapter 6 Taking medical readings 6.1.11 Monitoring respiration rate with ECG cable The Tempus Pro allows the user to monitor the patients respiration through the ECG cable by measuring the change in the patients impedance as their chest wall moves (impedance pneumography). This section will explain how to use this feature. The device defaults to impedance respiration being off. By turning Impedance Respiration on, it can be measured through one ECG lead on 3-, 4-, 5- or 12-lead cables, unless the Capnometer is in operation. Do not operate the Tempus with any other monitor with respiration measurements on the same patient. The two devices could affect the respiration accuracy of each other. Do not use the Tempus as an apnoea monitor. WARNING WARNING Respiration rate from ECG leads By default, the Tempus Pro will be set to monitor respiration rate through the ECG leads when it is supplied. WARNING If capnography is used, the Tempus will always obtain its respiration rate measurement from this parameter. If capnography is not available, then respiration will be derived from the ECG leads using an impedance-based method. In this case, users are reminded that the reading represents a cyclic change in measured impedance which is interpreted to be the change of impedance as the chest moves out and in. Users should note that this is therefore an indirect reading of respiration. WARNING Impedance pneumography detects respiratory effort through changes in chest volume. However, No Breath episodes with continued respiratory effort may go undetected. Always monitor and set alarms for SpO2 when using impedance pneumography to monitor respiratory function. WARNING With any monitor that detects respiratory effort through impedance pneumography, artefact due to patient motion, apnoea mattress shaking, or electrocautery use may cause apnoea episodes to go undetected. Always monitor and set alarms for SpO2 when using impedance pneumography to monitor respiratory function. WARNING WARNING WARNING WARNING When using impedance pneumography, dont use the Tempus with another respiration monitor on the same patient, because the respiration measurement signals may interfere with one another. Impedance pneumography is not recommended for use on paced patients, because pacemaker pulses may be falsely counted as breaths. Impedance pneumography is not recommended for use with high frequency ventilation. Since impedance pneumography uses the same leads as the ECG channel, the Tempus unit determines which signals are cardiovascular artefact and which signals are the result of respiratory effort. If the breath rate is within five Percent of the heart rate, the monitor may ignore breaths and trigger a respiration alarm. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 74 6.1 Electrocardiography (ECG) CAUTION CAUTION CAUTION CAUTION Users should note that in the case of supine patients, breathing may involve relatively greater movement of the abdomen (and consequently less expansion of the chest) during breathing. In this case chest impedance changes may not be significant to produce reliable readings. If impedance respiration is being used, the ECG electrodes should be placed on the torso and not the limbs. Impedance respiration measurements are highly subject to patient movement. The impedance changes across the chest during breathing can be easily masked by patient movement or muscle noise during movement. In motion environments care should be taken to observe best practise on electrode site preparation, electrode and cable securement, securement of the Tempus and securement of the patient. RDT recommends using capnography to measure respiration in motion environments. Impedance-based respiration monitoring is performed through the Lead II wires (RA-LL) by default. This can be changed to use Lead I (RA-LA). For the most reliable respiration measurement, users should select the lead which has the largest R-wave. Your choice depends on the ECG cable type connected and the lead chosen for ECG waveform monitoring:

ECG cable type connected Lead selected for ECG waveform monitoring Leads available for respiration monitoring 3-lead 4-, 5- or 12-lead Lead I Lead II Lead III Any Lead I only Lead II only Lead I or Lead II Lead I or Lead II

(independent of ECG waveform) Note If capnography is in use, the waveform will automatically change to CAPNO and will display the end tidal CO2. The results will change to additionally display the ETCO2 reading. Once the ECG cable is attached, respiration measurements will be started. The device will produce a reading once an average of 3 readings has been obtained. Consequently, with very low respiration rates

(e.g. 5 per minute), a reading may not be obtained for 30 seconds or more. The product will as a consequence also have a slower level of responsiveness to marginal changes in respiration rates with patients with such low breathing rates. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 75 Chapter 6 Taking medical readings The pneumography

(respiration) waveform is shown here The respiration rate is shown here Impedance respiration settings Pressing anywhere on the Respiration area brings up the Respiration Settings Menu. Note If capnography is in use, the waveform shown will be labelled CAPNO and will display the end tidal CO2. In this state pressing on the waveform will bring up the Capnometer Settings Menu. Menu option Menu screen Respiration limits (rpm) set the upper and lower alarm limits for respiration. Respiration wave speed (mm/s) set wave speed to 3.1, 6.25 or 12.5. This setting is independent of other waveforms. Respiration lead select which ECG lead will measure respiration rate. Respiration wave gain use the up and down arrows to adjust wave height (gain). Respiration monitoring turn impedance respiration off or on. Use this, for example, where patient movement is too great to allow stable impedance measurements to be taken. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 76 6.1 Electrocardiography (ECG) 6.1.12 Monitoring heart/pulse rate with no leads If the ECG is not attached to the patient, then the heart rate will be taken from the pulse oximeter if this is attached to the patient. Otherwise no heart rate will be shown. Note If the ECG is not connected but the pulse oximeter is, the heart rate will be show in the same place, in green but the signal will be derived from the pulse oximeter. In this event the reading will be labelled as shown below. In this condition the systole (heart symbol) is not shown and the systole tone will not sound. High and low heart rate alarms will operate as before. Pulse rate when measured from the pulse oximeter Alarm settings remain as they were set for the ECG Pulse Rate Measured from the Pulse Oximeter If the ECG is inoperable then the ECG will either show a Leads off error for the specific Lead that is unavailable or will show a technical error as described in section 7.4 Technical alarms. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 77 Chapter 6 Taking medical readings 6.2 Non-invasive blood pressure (NIBP) WARNING WARNING WARNING WARNING This device should not be used when oscillometric pulses may be altered by other devices or techniques such as External Counter pulsation (ECP) or Intra-Aortic Balloon Pump Counter pulsation. DO NOT use the Blood pressure monitor for any purpose other than specified in this manual. DO NOT attach the cuff to a limb being used for IV infusions as the cuff inflation can block the infusion, potentially causing harm to the patient. You must use the right size of blood pressure cuff to suit the patient. The cuffs bladder length should be at least 80% of the limbs circumference which the cuff width should be equal to 40% of the limbs circumference. Selecting a cuff that is too small will result in measurements higher than the patients actual blood pressure. Conversely using too large a cuff will result in too low a reading. The appropriate cuff sizes are:

Disposable neonate cuff size 1 (3-6 cm), Disposable neonate cuff size 2 (4-8 cm), Disposable neonate cuff size 3 (6-11 cm), Disposable neonate cuff size 4 (7-13 cm), Disposable neonate cuff size 5 (8-15 cm), Disposable infant cuff (8-13 cm), ORANGE infant cuff (8-13 cm), GREEN child (12-19 cm), GREEN child LONG (12-19 cm), ROYAL BLUE small adult (17-25 cm), ROYAL BLUE small adult LONG (17-25 cm), NAVY BLUE normal adult (23-33 cm), NAVY BLUE normal adult LONG (23-33 cm), BURGUNDY large adult (31-40 cm), BURGUNDY large adult LONG (31-40 cm), BROWN adult thigh (38-50 cm). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 78 6.2 Non-invasive blood pressure (NIBP) WARNING Always set the Tempus Pro to the correct patient age to ensure the initial inflation pressure is set correctly. The Tempus uses the definitions of patient age provided in IEC80601-2-30 as follows:

Neonate Children 28 days old or less if born at term (based on 37-week gestation), otherwise up to 44 gestational weeks. Paediatric (Child) Children of 29 days up to and including 12 years old. Adult Individuals 13 years old or older. Failure to set the correct age will result in the Tempus using an inappropriate cuff inflation pressure which could cause serious harm to a neonate or infant. For pressures, see 14.1.5 Non-invasive blood pressure. Setting the patient age to 2 years or less will mean that inflation pressures, alarm defaults and alarm ranges will be set to those for a neonate (per IEC80601-2-30). If you do not set the patient age, the Tempus will use the default patient age group

(see the Tempus Pro Maintenance Manual). Ensure that the patient age/type is always entered for non-adult patients see 9.3.5 Entering patient details. WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING CAUTION The Tempus Pro non-invasive blood pressure monitor is not for use with pregnant, including pre-eclamptic, patients. The Tempus Pro may not operate effectively on patients who are experiencing convulsions or tremors, or who are moving or are in motion (transport) environments. Prolonged or repetitive use of the blood pressure cuff may harm skin integrity and circulatory status. Observe the limb concerned to check that circulation is not impaired. Do not attempt to take NIBP readings from patients undergoing cardiopulmonary bypass. If you suspect a non-invasive blood pressure measurement is invalid, repeat the measurement. If you remain unsure about the validity of the reading, then take another measurement using another piece of equipment or a different method. Do not apply the cuff over a wound, as this can cause further injury. Do not apply and pressurize the cuff on any limb where intravascular access or therapy such as an IV line, saline lock or an arterio-venous (A-V) shunt, is present as it may cause temporary interference with blood flow and result in injury to the patient. Do not apply and pressurize the cuff on the arm on the side of mastectomy. Application of continuous cuff pressure due to kinking of the blood pressure hose can interfere with blood flow and result in harmful injury to the patient. Accuracy of any blood pressure measurement may be affected by the position of the subject, his or her physical condition and use outside of the operating instructions detailed in Tempus Pro User/Operator Manual - 41-2001EN-00 Page 79 Chapter 6 Taking medical readings this manual. Interpretation of blood pressure measurements should be made only by a physician or trained medical staff. Hoses of a certain material and/or durometer may cause the module to perform in an improper fashion. Only use hoses provided by RDT. Incorrectly sized cuffs may cause measurement inaccuracy or errors. If the blood pressure cuff is on the same limb as a pulse oximeter probe, the oxygen saturation results will be altered when the cuff occludes the brachial artery. To obtain accurate blood pressure readings, the cuff must be the correct size, and also be correctly fitted to the patient. Incorrect size or incorrect fitting may result in incorrect readings. When a cuff is going to be positioned on a patient for an extended length of time, be sure to occasionally check the limb for proper circulation. Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the formation of urticaria (allergic reaction including raised edematous patches of skin or mucous membranes and intense itching) caused by the fabric material of the cuff. Petechia (a minute reddish or purplish spot containing blood that appears in the skin) formation or Rumple-Leede phenomenon (multiple Petechia) on the forearm, following the application of the cuff, may lead to Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets associated with hemorrhagic conditions), or phlebitis

(inflammation of a vein) may be observed. Blood pressure readings can be affected by patient movement, speech, incorrect sizing and placement of the cuff and environmental factors (vibration, motion, noise etc.). Care should be taken to ensure that motion and other artefacts are removed or reduced when taking blood pressure readings. Do not place the cuff on the same limb as the pulse oximeter sensor as the cuff may prevent the pulse oximeter sensor from reading reliably during NIBP measurement cycles. Ensure the cuff is wrapped firmly around the arm; a loosely applied cuff can result in artificially high readings. Compression or restriction of the blood pressure hose or cuff, or induced movement or vibration or very low pulse volumes may prevent the monitor from taking a reading or may influence the accuracy of the reading obtained. The Tempus Pro non-invasive blood pressure monitor is designed to work with the cuffs and hoses supplied. Use of other cuffs and hoses may compromise performance and accuracy. The Tempus Pro non-invasive blood pressure monitor does not provide any specific burns protection parts for non-invasive blood pressure (in accordance with IEC80601-2-30 cl 201.7.9.2.101). CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Note Note Note Tempus Pro User/Operator Manual - 41-2001EN-00 Page 80 6.2 Non-invasive blood pressure (NIBP) 6.2.1 Getting started The Tempus is intended to be used to take non-invasive blood pressure readings from neonates, children, small adults, adults and large adults. Blood pressure measurements can be affected by the position, physiologic condition, or activity level of the patient, who should be seated, standing or lying down depending on the usage model for the device or procedure being performed on the patient. If the patient is seated, they should have legs uncrossed, feet flat on the floor and back and arms supported. If the patient is lying (supine) they should not have their legs crossed. The patient should be comfortable, relaxed as much as possible and not talking during the NIBP measurement. Before taking the first measurement, a period of at least 5 minutes should elapse to give time for blood pressure stabilization. When the pressure in the cuff increases, the patient should avoid excess movement during measurements. Let the cuffed arm hang or lay loosely, slightly away from the body. Avoid flexing the muscles or moving the hand and fingers of the cuffed arm. Avoid having the cuff or the hose next to vibrating surfaces. The patient should be advised to relax as much as possible and not talk during the measurement procedure. The operator should be positioned in their normal operating position. To take a non-invasive blood pressure reading, remove the cuff from the rear of the device. If a cuff is not attached to the hose, or the hose is not attached to the Tempus then make the necessary connections (twist and lock for the cuff and push/latch to attach the hose). Ensure the cuff is wrapped firmly around the limb with the cuff placed centrally between the two joints of the limb i.e. 2-5 cm above the elbow joint or 5-10 cm above the knee. Ensure the end of the cuff wraps around within the two range lines if it does not then use a different cuff. Ensure the cuffs artery marker is placed over the position of the artery e.g. between the bicep and the tricep for the brachial artery on the arm. Ensure the hose is not kinked, crushed or damaged. Remember to place the middle of the cuff at the same level as the right atrium of the heart. Placing the cuff substantially higher or lower than the heart will result in incorrect readings. Remember that there may be differences in results between arms and legs, left and right side and can be affected by the patients position (sitting, standing, lying down), exercise or their physiologic condition. Once the cuff is attached, press the start button shown within the Blood Pressure area. The reading can be stopped at any time by pressing the button again (it will be labelled STOP). If an unexpected reading is obtained, wait for a brief period and then take the reading again having checked the hose for leaks and kinks, the correct placement of the cuff and the patients orientation. Remember that the pressure reading can be affected by common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arteriosclerosis, poor perfusion, diabetes, age, pregnancy, pre-

eclampsia, renal diseases, patient motion, trembling, shivering etc. 6.2.2 Taking readings While the cuff is inflating and deflating, the icon in the start button will change to reflect the status of the reading i.e.:

Cuff is inflating;

Cuff is deflating. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 81 Chapter 6 Taking medical readings Shows the Systolic, Mean and Diastolic results Shows the time the reading was taken Indicates that readings will be taken repetitively at the interval shown Press here to start and stop blood pressure readings. The graphic shows the status of the device The Non-Invasive Blood Pressure Section of the Home Screen Once the measurement has been taken, the icon will change to indicate that the device is on timer as shown below:

Cuff is on timer;

Cuff is on timer;

Cuff is on timer;

Reading is about to start. If the device is not set to take readings automatically then it will show the following:

Blood pressure monitor is idle. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 82 6.2 Non-invasive blood pressure (NIBP) 6.2.3 NIBP settings Pressing anywhere on the non-invasive blood pressure area brings up the NIBP settings menu:

Note The Tempus Pro Maintenance Manual describes how to set the Tempus to automatically clear the NIBP reading after 5 minutes if a new reading has not been taken. Menu option Menu screen Start start or stop NIBP readings. Mode select Manual, Auto or Rapid Cuff. Auto interval time (mins) when in Auto mode, set the time between NIBP readings. Systolic limits, Mean limits and Diastolic limits (mmHg) set the lower and upper alarm limits. Initial inflation (mmHg) change the initial inflation pressure. The default value is set by Tempus depending on patient age group. Reading format change the format of displayed NIBP readings. NIBP mode The NIBP can be set to read in three different modes:

Auto allows the user to set the Tempus to take readings automatically on a cycle (3 mins default, can be set to 2 mins, 3 mins, 5 mins, 10 mins, 15 mins, 30 mins and 60 mins). Manual allows the user to take a single reading only every time the NIBP button is pressed. Rapid Cuff where the Tempus will take as many readings as it can in 10 minutes and will then reset to Auto. If an NIBP technical alarm occurs while in Rapid Cuff mode, the alarm will be reported and the mode will reset to Auto. CAUTION Users should note that Rapid Cuff will only allow a short period between measurements for arterial recovery. Repeated use of the RapidCuff mode could have physiological effects including effects on the readings obtained. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 83 Chapter 6 Taking medical readings Initial inflation The user can adjust the initial NIBP inflation pressure. The default is set by the Tempus depending on patient age group see 9.3.5 Entering patient details. NIBP adjusts its inflation pressure dynamically between readings so this setting only applies to the first reading and when it is manually adjusted. Patient Type Default initial inflation Range Adult Paediatric (29 days to 12 years) Neonate (<29 days) 160 mmHg 140 mmHg 90 mmHg 120 to 280 mmHg 80 to 280 mmHg 60 to 140 mmHg NIBP reading format The Reading format control allows you to choose between two formats for displaying NIBP readings:

NIBP reading format S/D (M) NIBP reading format (M) S/D S = systolic D = diastolic M = mean Note Regardless of the reading format chosen, the Tempus Pro will continue to monitor the systolic, mean and diastolic pressures and will still output alarms when thresholds are exceeded. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 84 6.3 Pulse oximetry 6.3 Pulse oximetry WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Do not use this device in the presence of high EMI/RFI radiation. High EMI/RFI radiation may cause induced current to the SpO2 sensor resulting in patient injury. This device may give inaccurate readings in the presence of strong electromagnetic sources, such as electrosurgery equipment. This device may give inaccurate readings in the presence of computed tomography

(CT) equipment. Prolonged use or the patients condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. Prolonged use may cause blisters, skin deterioration, and discomfort. Incorrectly applied sensors may give inaccurate readings. SpO2 measurements may be inaccurate in the presence of high ambient light. Shield the sensor area (with a towel, for example) if necessary. Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings. Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. Significant levels of dysfunctional haemoglobins, such as carboxyhaemoglobin or methaemoglobin, will affect the accuracy of the SpO2 measurement. Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin, porfimer sodium and metatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at least every hour and observe for signs of tissue damage. More frequent sensor site changes or inspections may be indicated depending upon the photodynamic agent used, agent dose, skin condition, total exposure time or other factors. Use multiple sensor sites. Optical cross-talk can occur when two or more sensors are placed in close proximity. It can be eliminated by covering each site with opaque material. Optical cross-talk may adversely affect the accuracy of the SpO2 readings. Obstructions or dirt on the sensors red light or detector may cause a sensor failure or inaccurate readings. Make sure there are no obstructions and the sensor is clean. Under certain clinical conditions, pulse oximeters may not display SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 85 Chapter 6 Taking medical readings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Do not use the pulse oximeter for any other purpose than specified in this manual. It should NOT be used as an apnoea monitor. Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis. A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analysed by a laboratory co-oximeter to completely understand the patients condition. Tissue damage can be caused by incorrect application or use of the sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor. Interfering Substances: Carboxyhaemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhaemoglobin present. Reposition the oximeter probe at least once every hour to allow the patient's skin to respire. This time should be reduced in ambient temperatures over 41 C. No other special actions are required for use in such ambient temperatures although users are advised to check the sensor site frequently in high temperatures to avoid skin damage. The SpO2 sensor should snugly fit the finger without straining it and if not alternative fingers should be tried. The probe is sized for patients who weigh 20 kg /44 lbs or more. The probe can be used either on patients fingers, thumbs or largest toe. The plethysmogram may become unstable on patients who are experiencing convulsions or tremors, who are moving or are in motion (transport) environments. Always read and follow the instructions on the packaging of SpO2 sensors regarding their storage, use and disposal. In particular take into account any information regarding toxicity. For measurements of high or low SpHb readings, blood samples should be analysed by laboratory instruments to completely understand the patients condition. A pulse oximeter cannot measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present. For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis

(CO-Oximetry) of a blood sample should be performed. Haemoglobin synthesis disorders may cause erroneous SpHb readings. Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO, SpHb, and SpOC measurements. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 86 6.3 Pulse oximetry WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Motion artefact may lead to inaccurate SpMet, SpCO, SpHb, and SpOC measurements. Severe anaemia may cause erroneous SpO2 readings. Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements. With very low perfusion at the monitored site, the readings may read lower than core arterial oxygen saturation. Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of additional tape can cause skin damage or damage the sensor. If the sensor is wrapped to tightly or supplemental tape is used, venous congestion/pulsations may occur causing erroneous readings. Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the floor). Venous pulsations may cause erroneous low readings (e.g. tricuspid valve regurgitation). WARNING Loss of pulse signal can occur when:

The sensor is too tight. The patient has hypotension, severe vasoconstriction, severe anaemia, or hypothermia. There is arterial occlusion proximal to the sensor. The patient is in cardiac arrest or is in shock. WARNING WARNING WARNING WARNING The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display. Verify patient's pulse rate against the ECG heart rate. Misapplied sensors or sensors that become partially dislodged may cause either over or under reading of actual arterial oxygen saturation. Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 87 Chapter 6 Taking medical readings WARNING WARNING WARNING WARNING CAUTION CAUTION CAUTION CAUTION Before use, carefully read the sensor's Directions for Use. To avoid cross contamination only use Masimo single use sensors on the same patient. Unless otherwise specified, do not sterilize sensors or patient cables by irradiation, steam, autoclave or ethylene oxide. See the cleaning instructions in the directions for use for the Masimo re-useable sensors. Unplug the sensor from the monitor before cleaning or disinfecting to prevent damaging sensor or monitor, and to prevent user safety hazards. Users are reminded that because pulse oximeter measurements are statistically distributed, only about two-thirds of measurements can be expected to fall within Arms of the value measured by a co-oximeter. Information on the clinical desaturation trials performed to validate the oximeter is available on request. Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers

(sensors) may cause improper results. Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance imaging

(MRI) scanning. Induced current could potentially cause burns. The Pulse CO-Oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. CAUTION Exercise caution when applying a sensor to a site with compromised skin integrity. Applying tape or pressure to such a site may reduce circulation and/or cause further skin deterioration. CAUTION Note Note Note Note Circulation distal to the sensor site should be checked routinely. SpO2 averaging is the number of pulse beats over which the SpO2 value is averaged; pulse averaging is the number of seconds over which the pulse value is averaged. DESAT trails were performed in the normal sensitivity mode. The plethysmogram is not normalised. The pulse oximeter probe is for use with intact skin only. The probe used is not sterile and contains no latex. Patient contact materials have undergone extensive biocompatibility testing; further information is available on request. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 88 6.3 Pulse oximetry Note Note Note Note Note Note Note Note Note Any condition that restricts blood flow, such as use of a blood pressure cuff (other than the Tempus Pro cuff used in accordance with the instructions herein) may cause an inability to determine accurate pulse and SpO2 readings. SpO2 measurements may be adversely affected in the presence of high ambient light levels

(e.g. strong sunlight). This may be more noticeable with disposable probes. If necessary, shield the sensor area (e.g. with a towel) or a Masimo light shield. Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. Performance and safety test data are available on request from RDT, see RDT contact details. The graphical displays of pulse rate, SpO2 and pulse strength are not proportional to the pulse volume. The amplitude of the waveform is adjusted on an on-going basis to provide the largest size waveform possible. Do not attempt to normalise the waveform to any scale. The SpO22 sensor should be on the opposite arm to the blood pressure cuff. The arm of the patient must be kept still and either be horizontal to the shoulder (if the patient is lying down) or below the shoulder (if the patient is sitting upright). If the finger selected does not give good results, this could be due to poor perfusion of blood. Ensure that the finger is inserted all way into the clip, or try taking a reading on another finger. If the accuracy of any measurement does not seem reasonable, first check the patients vital signs by alternate means and the check the MS board pulse oximeter for proper functioning. NO IMPLIED LICENSE - Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables that would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device. Inaccurate measurements may be caused by:

Significant levels of dysfunctional haemoglobins. (e.g., carboxyhaemoglobin or Incorrect sensor application or use methaemoglobin) Intravascular dyes such as indocyanine green or methylene blue. Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material) Excessive patient movement. Venous pulsations. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 89 Chapter 6 Taking medical readings Note Loss of pulse signal can occur in any of the following situation:

The sensor is too tight. There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight. A blood pressure cuff is inflated on the same extremity as the one with a SPO2 sensor attached. The patient has hypotension, severe vasoconstriction, severe anaemia, or hypothermia. There is arterial occlusion proximal to the sensor. The patient is in cardiac arrest or is in shock. Note High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 90 6.3 Pulse oximetry The following warnings, cautions and notes are reproduced verbatim from Masimo document R-CSD-1117

(revision P):

GENERAL The pulse co-oximeter is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. WARNING As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Do not place the pulse co-oximeter or accessories in any position that might cause it to fall on the patient. Do not start or operate the pulse co-oximeter unless the setup was verified to be correct. Do not use the pulse co-oximeter during magnetic resonance imaging (MRI) or in an MRI environment. Do not use the pulse co-oximeter if it appears or is suspected to be damaged. Explosion hazard: Do not use the pulse co-oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. To protect against injury, follow the directions below:

o Avoid placing the device on surfaces with visible liquid spills. o Do not soak or immerse the device in liquids. o Do not attempt to sterilize the device. o Use cleaning solutions only as instructed in this operator's manual. o Do not attempt to clean the device while monitoring a patient. To protect from electric shock, always remove the sensor and completely disconnect the pulse co-oximeter before bathing the patient. If any measurement seems questionable, first check the patients vital signs by alternate means and then check the pulse co-oximeter for proper functioning Inaccurate SpCO and SpMet readings can be caused by:

Improper sensor application Intravascular dyes such as indocyanine green or methylene blue o o o Abnormal hemoglobin levels o Low arterial perfusion o Low arterial oxygen saturation levels including altitude induced hypoxemia o Elevated total bilirubin levels o Motion artifact Tempus Pro User/Operator Manual - 41-2001EN-00 Page 91 Chapter 6 Taking medical readings WARNING Inaccurate SpHb and SpOC readings may be caused by:

Improper sensor application Intravascular dyes such as indocyanine green or methylene blue o o o Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc. o Elevated PaO2 levels o Elevated levels of bilirubin o Low arterial perfusion o Motion artifact o Low arterial oxygen saturation levels o Elevated carboxyhemoglobin levels o Elevated methemoglobin levels o Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. o Vasospastic disease such as Raynaud's o Elevated altitude o Peripheral vascular disease o Liver disease o EMI radiation interference Inaccurate SpO2 readings may be caused by:

Improper sensor application and placement o o Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. o Elevated levels of bilirubin o Elevated levels of dyshemoglobin o Vasospastic disease, such as Raynauds, and peripheral vascular disease o Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. o Hypocapnic or hypercapnic conditions o Severe anemia o Very low arterial perfusion o Extreme motion artifact o Abnormal venous pulsation or venous constriction o Severe vasoconstriction or hypothermia o Arterial catheters and intra-aortic balloon o o Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc. o Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal Intravascular dyes, such as indocyanine green or methylene blue fingers. etc. o Skin color disorders Tempus Pro User/Operator Manual - 41-2001EN-00 Page 92 6.3 Pulse oximetry WARNING Interfering Substances: Dyes or any substance containing dyes that change usual blood pigmentation may cause erroneous readings. The pulse co-oximeter should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms. The pulse co-oximeter is not an apnoea monitor. The pulse co-oximeter may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements. The pulse co-oximeter may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements. The pulse co-oximeter should not be used for arrhythmia analysis. SpCO readings may not be provided if there are low arterial saturation levels or elevated methemoglobin levels. SpO2, SpCO, SpMet, and SpHb are empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). Do not adjust, repair, open, disassemble, or modify the pulse co-oximeter or accessories. Injury to personnel or equipment damage could occur. Return the pulse co-oximeter for servicing if necessary. CAUTION Do not place the pulse co-oximeter where the controls can be changed by the patient. Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any power source. When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy. Do not place the pulse co-oximeter on electrical equipment that may affect the device, preventing it from working properly. If SpO2 values indicate hypoxaemia, a laboratory blood sample should be taken to confirm the patients condition. If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. Change the application site or replace the sensor and/or patient cable when a Replace sensor and/or Replace patient cable, or a persistent poor signal quality message (such as Low SIQ) is displayed on the host monitor. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor. If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period. The device must be configured to match your local power line frequency to allow for the cancelation of noise introduced by fluorescent lights and other sources. To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the pulse co-oximeter is used. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 93 Chapter 6 Taking medical readings CAUTION Variation in haemoglobin measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patients clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analysed by laboratory devices prior to clinical decision making to completely understand the patients condition. Do not submerge the pulse co-oximeter in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the pulse co-oximeter. Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. Disposal of product - Comply with local laws in the disposal of the device and/or its accessories. To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to the pulse co-oximeter. Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual. Note A functional tester cannot be used to assess the accuracy of the pulse co-oximeter. High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the pulse co-oximeter to obtain vital sign readings. When using the Maximum Sensitivity setting, performance of the "Sensor Off"

detection may be compromised. If the device is in this setting and the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental "noise" such as light, vibration, and excessive air movement. Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. Additional information specific to the Masimo sensors compatible with the pulse oximeter, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU). Cables and sensors are provided with X-Cal technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 94 6.3.1 Getting started To use the pulse oximeter, remove the soft finger probe from the back of the device. Attach it to a well-

perfused finger of the patient taking care to ensure it is not the same arm which has a blood pressure cuff attached. The readings will begin a few seconds after the probe is attached to the patient. 6.3 Pulse oximetry The plethysmogram is shown continuously The Pulse Oximetry Section of the Home Screen The SpO2 reading is provided shown here The signal strength and perfusion index of the site are shown here The SpO2 section gives the oxygen saturation of the blood and shows the plethysmogram, signal strength

(in bar graph form) and the perfusion index. The Signal Quality bar graph shows how well the pulse sensor is detecting the pulse. The amplitude of the indication indicates the quality of detection. If the indication on the Signal Strength meter is low, or becomes low, then the finger sensor should be repositioned. Similarly, the Perfusion Index gives a numerical indication of the level of arterial pulsatile blood at the sensor site. The Pulse Rate displayed on the Tempus Pulse Oximeter may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed on the Tempus to be significantly different than the ECG heart rate. The perfusion index (PI) indicator provides a relative numeric indication of the pulse strength at the monitoring site. It is a calculated percentage between the pulsatile signal and non-pulsatile signal of arterial blood moving through the site. PI may be used to find the best perfused site and to monitor physiological changes in the patient. It displays an operating range of 0.02 % to 20.00 %. A percentage greater than 1.00

% is desired. Extreme changes in the display number are due to motion artefact and changes in physiology and blood flow. The device indicates perfusion on a 7-bar LED indicator. The lower two segments of the bar will turn red when the amplitude of the arterial pulsations is very low (low perfusion). It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation. This localized hypoxemia may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that correlates with the ECG heart rate.) CAUTION If the low perfusion indication is frequently displayed, find a better-perfused monitoring site. In the interim assess the patient and if indicated verify oxygenation status through other means. 6.3.2 Pleth variability index Pleth Variability Index or PVI helps users to discern between patients who may respond to fluid from those who may not. PVI has been shown to help clinician to predict fluid responsiveness in mechanically ventilated patients under general anaesthesia, defined as a significant increase in cardiac output after fluid administration. PVI is an automatic measure of the dynamic change in Perfusion Index (PI) that occurs during the respiratory cycle. PVI = ((PImax-PImin)/PImax) x 100. The greater the PVI, the more likely the patient will respond to fluid administration. Typically, a PVI of >14%

prior to volume expansion is predictive that a mechanically ventilated patient will respond to fluid Tempus Pro User/Operator Manual - 41-2001EN-00 Page 95 Chapter 6 Taking medical readings administration (81% sensitivity). A PVI prior to volume expansion is predictive that a mechanically ventilated patient will not respond to fluid administration (100% specificity). PVI is an option for Tempus Pro. The Pulse Oximetry Section with PVI The PVI value is shown here 6.3.3 Taking readings Note Depending on which of the features have been purchased, some of the features shown below may not be available on your Tempus Pro device. 1. Remove the patient cable from the RapidPak area of the Tempus. 2. Connect the SpO2 cable to the Tempus Pro. 3. Attach the chosen sensor to the patient cable:

SpO2 sensor - SpO2, PI and PVI SpCO sensor - SpCO, SpMet, Sp02, PI and PVI SpHb sensor - SpHb, SpMet, SpOC, Sp02, PI and PVI Attach it to a well-perfused finger of the patient taking care to ensure it is not the same arm which has a blood pressure cuff attached. The measurement will begin as soon as the probe is attached to the patient but different values take different lengths of time to appear on the screen. Standard Waveform view Large Waveform view Tempus Pro User/Operator Manual - 41-2001EN-00 Page 96 6.3.4 Features The plethysmogram and signal strength are shown continuously 6.3 Pulse oximetry The SpO2 reading is shown here Masimo Rainbow parameters are displayed here The SpCO index, Perfusion index and Pleth Variability Index of the site are shown here The Pulse Oximetry section of the home screen Depending on which features have been purchased for your Masimo Rainbow Pulse OX and which sensor you are using will depend on which of the following features the Tempus Pro can monitor. Masimo SET measurements supplied as standard:

SpO2 - Intended for non-invasive measurement of arterial blood saturation and also provides pulse rate when ECG is not attached. Pulse Rate (PR). Perfusion Index (PI) - Gives a numerical indication of the level of arterial pulsatile blood at the sensor site. Masimo SET Rainbow measurements purchased as optional upgrades:

SpCO - Allows clinicians to noninvasively and immediately detect elevated levels of carbon monoxide. SpMet - Allows clinicians to noninvasively and immediately detect elevated levels of methaemoglobin in the blood. SpHb Index - Gives continuous monitoring of the haemoglobin levels in blood. SpOC - Gives the patients oxygenation status by calculating the haemoglobin and oxygen saturation. PVI purchased as an optional upgrade:

Pleth Variability Index (PVI) - Helps clinicians noninvasively and continuously assess fluid status of patients. The Signal Quality waveform (underneath the plethysmogram) shows how well the pulse sensor is detecting the pulse. The height of the peak indicates the strength of the signal, if the peaks are short the finger sensor should be repositioned. The Pulse Rate displayed on the Tempus Pulse Oximeter may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed on the Tempus to be significantly different than the ECG heart rate. The device indicates perfusion. It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation. This localized hypoxemia may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that correlates with the ECG heart rate). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 97 Chapter 6 Taking medical readings CAUTION If the low perfusion indication is frequently displayed, find a better-perfused monitoring site. In the interim assess the patient and if indicated verify oxygenation status through other means. 6.3.5 Pulse oximetry probes The following pulse oximetry sensors may be used with the Tempus Pro: standard, SpCO or SpHb. Each sensor shows a different range of parameters. There is no single sensor that shows all parameters. The standard adult SpO2 reusable sensor reads SpO2, PI and PVI The SpCO sensor reads SpCO, SpMet, SpO2, PI and PVI The Standard adult SpO2 section The Pulse Oximetry section with SpCO The SpHb sensor reads SbHb, SpMet, SpOC, SpO2, PI and PVI The Pulse Oximetry section with SpHb Depending on which sensor is used the Tempus will display only the available parameters. Note Tempus Pro User/Operator Manual - 41-2001EN-00 Page 98 6.3 Pulse oximetry 6.3.6 Pulse oximeter settings Pressing anywhere in the plethysmogram area brings up the Pulse Oximeter Settings menu:

The SpCO, SpMet, SpHb and SpOC limits are only activated when their Masimo licenses have been installed and the appropriate probes are plugged in. Note PI and PVI alarms are only available in Tempus Pro devices with part numbers ending in

"-R". Menu option Menu screen SpO2, SpCO and SpMet limits (%) set the upper and lower alarm limits for SpO2, SpCO and SpMet. SpHb limits and settings open the SpHb Settings menu, see 6.3.7 SpHb settings. HR/PR source select ECG or Pulse oximeter as the heart/pulse rate source. Large pleth waveform turn the large pleth waveform display on and off. Sensitivity mode adjust sensitivity by pressing Max, Norm or APOD. Averaging time (s) use the up and down arrows to adjust averaging time in seconds. FastSAT turn FastSAT on or off. Cardiac wave speed (mm/s) change wave speed. This setting is common to ECG, Sp02 and IP. HR/PR beat volume - volume of the audible tone that the Tempus emits every time a heartbeat is detected. SpOC limits (ml/dl) set the upper and lower alarm limits for SpOC. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 99 Chapter 6 Taking medical readings Menu option Menu screen PI limits (%) set the upper and lower alarm limits for Perfusion Index. PVI limits (%) set the upper and lower alarm limits for Pleth Variability Index. Pulse tones Pulse tones can be turned on from either the Pulse Oximeter Settings menu or the ECG Settings menu using the settings:

HR/PR source = pulse HR/PR beat volume = 20% (or above) When pulse tones are turned on Tempus Pro emits a beep for each pulse beat detected. The beep tone

(frequency) depends on the value of pulse ox saturation (SpO2). Higher SpO2 values mean that each beat is emitted with a higher tone beep and vice-versa. So the tone drops as SpO2 (%) falls, with the lowest frequency tone at values of SpO2 = 80% or below. Alarm tones have priority over pulse tones. When pulse tones are enabled, user interface touch screen sounds are suppressed. Pulse tones are automatically enabled if the laryngoscope is used. Note Note Averaging time The pulse oximeter can be set to average its heart rate reading over different time periods. By default, this is 8 seconds. This can be adjusted to make the reading more or less responsive. The available settings are: (2-4 seconds, 4-6 seconds, 8 seconds, 10 seconds, 12 seconds, 14 seconds and 16 seconds). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 100 6.3 Pulse oximetry Sensitivity mode The Pulse Oximeter is equipped with 3 different sensitivity modes. Each mode allows the clinician to change the sensitivity settings of the device to meet the increased demands of the patients physiological condition or enable it to work during periods of low perfusion and/or motion. They are as follows:

Normal Sensitivity (Norm) This is the recommended mode for patients that are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as an intensive care unit (ICU). Adaptive Probe Off Detection (APOD) This is the recommended start-up monitoring mode for most patients with acceptable perfusion or where a more robust sensor off detection is desired. It is the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient. Maximum Sensitivity (Max) - This mode is recommended for patients with low perfusion or when the low perfusion or low signal quality message is displayed on the screen in APOD or normal sensitivity mode. This mode is not recommended for care areas where patients are not monitored visually, such as general wards. It is designed to interpret and display data at the measuring site when the signal may be weak due to decreased perfusion. When a sensor becomes detached from a patient, it will have compromised protection against erroneous pulse rate and arterial saturation readings. Also, after a power off and on cycle, the sensitivity will change from the MAX to the factory default or user configured default setting of APOD or NORM. Large pleth waveform Large pleth waveform changes the display to show a bigger waveform. This will remove the Rainbow measurement parameters from the waveform section of the home screen and move them to the tile on the right. The parameters will then rotate every 5 seconds. Large Pleth Waveform view Large Pleth Waveform section of the home screen Rotating Parameter section FastSAT FastSAT enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend. When FastSAT is On the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patients current oxygenation status. With FastSat, the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from 2-4 and 4-6 seconds, respectively. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 101 Chapter 6 Taking medical readings 6.3.7 SpHb settings Pressing the SpHb settings button (if activated) brings up the SpHb settings page:

Menu option Menu screen SpHb limits (g/dL) set the upper and lower alarm limits for SpHb. SpHb mode select Arterial or Venous. SpHb averaging select Short, Medium or Long. Sensor life remaining shows the remaining life of the pulse ox sensor. Sensor life remaining Sensor life remaining shows the life of the sensor. A tech alarm will sound to warn when the remaining life is low. If the patient is still being monitored when the sensor life reaches zero, it will continue to monitor the patient but must be changed once monitoring has finished. A further tech alarm will sound once monitoring of patient has finished. Note If monitoring is complete, remember to disconnect the sensor from the patient cable as this may impact the life expectancy of the sensor. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 102 6.4 Capnography 6.4 Capnography The capnography component of the Tempus unit is covered by one or more of the following US patents:

6,428,483; 6,997,880; 6,437,316; 7,488,229, 7,726,954; and their foreign equivalents. Additional patent applications pending. NO IMPLIED LICENSE Possession or purchase of this device does not convey any express or implied license to the device with unauthorized consumable CO2 sampling consumable products, which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO2 sampling consumable products. WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient. To ensure accurate performance and prevent device failure, do not expose the monitor to extreme moisture, such as rain. The monitor is a prescription device and is to be operated by qualified healthcare personnel. The Tempus Pro is not for apnoea detection. The Tempus Pro is not an apnoea monitor and does not provide apnoea alarming. If uncertain about the accuracy of any measurement, first check the patients vital signs by alternative means, and then make sure the monitor is functioning correctly. Carefully route the FilterLine to reduce the possibility of patient entanglement or strangulation. Do not lift the monitor by the FilterLine, as it could disconnect from the monitor, causing the monitor to fall on the patient. The use of accessories, transducers, sensors and cables other than those specified may result in increased emission and/or decreased immunity of the equipment and/or system. CO2 readings and respiratory rate can be affected by sensor application errors, certain ambient environmental conditions, and certain patient conditions. The FilterLine may ignite in the presence of oxygen if exposed to high heat. When using a sampling line for intubated patients with a closed suction system, do not place the airway adapter between the suction catheter and endotracheal tube. This is to ensure that the airway adapter does not interfere with the functioning of the suction catheter. Do not cut or remove any part of the sample line. Cutting the sample line could lead to erroneous readings. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 103 Chapter 6 Taking medical readings WARNING If too much moisture enters the sampling line (i.e., from ambient humidity or breathing of unusually humid air), the message Clearing FilterLine will appear in the message area. If the sampling line cannot be cleared, the message FilterLine Blockage will appear in the message area. Replace the sampling line once the FilterLine Blockage message appears. WARNING WARNING WARNING WARNING Loose or damaged connections may compromise ventilation or cause an inaccurate measurement of respiratory gases. Securely connect all components and check connections for leaks according to standard clinical procedures. Always ensure the integrity of the patient breathing circuit after insertion of the airway adapter by verifying a proper CO2 waveform (capnogram) on the monitor display. Do not lift the Tempus by the FilterLine as it could disconnect from the monitor causing the monitor to fall on the patient. Do not use the FilterLine H Set Infant/Neonatal during magnetic resonance imaging

(MRI) scanning. Using the FilterLine H Set Infant/Neonatal during MRI scanning could harm the patient. CAUTION During MRI scanning, the module must be placed outside the MRI suite. When the module is used outside the MRI suite, EtCO2 monitoring can be implemented using the FilterLine XL. CAUTION Use of a CO2 sampling line with H in its name (indicating that it is for use in humidified environments) during MRI scanning may cause interference. The use of non H sampling lines is advised. CAUTION Microstream EtCO2 sampling lines are designed for single patient use, and are not to be reprocessed. Do not attempt to clean, disinfect, sterilize or flush any part of the sampling line as this can cause damage to the monitor. CAUTION CAUTION CAUTION Dispose of sampling lines according to standard operating procedures or local regulations for the disposal of contaminated medical waste. Before use, carefully read the Microstream ETCO2 sampling lines Directions for Use. In high-altitude environments, ETCO2 values may be lower than values observed at sea level, as described by Daltons law of partial pressures. When using the monitor in high-

altitude environments, it is advisable to consider adjusting ETCO2 alarm settings accordingly. CAUTION Use of monitoring during continuous nebulised medication delivery may result in damage to the Tempus Pro which is not covered by the warranty. Disconnect the Capnometer sample line from the Tempus Pro or switch off the Tempus Pro during medication delivery. CAUTION Do not use on patients that cannot tolerate the removal of 50 ml/min from their total minute ventilation. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 104 6.4 Capnography The following conditions can potentially cause a change in the flow rate:

Water, mucous or other patient contaminate has entered the sample tubing. The sample tubing is crimped or pinched so that the sample flow rate has decreased. Damage to the sample line. The sample line has been cut, or split, causing the flow rate to increase. The Capnometer will require warming up if it is started from cold. The warm up time is specified in section 14.1.4. Once the Capnometer is warmed up, the capnogram will appear on the display. In order to avoid moisture build-up and sampling line occlusion during nebulisation or suction for intubated patients, remove the sampling line luer connector from the Tempus. Note Note Note The Tempus uses the Oridion Microstream FilterLine and CapnoLine systems to monitor CO2. Before using the Capnometer, select the appropriate cannula taking into account the patient age and the use of ventilation/intubation. NSN Oridion PN Description Application 6515-01-596-6547 015016 6515-01-586-3075 015018 6515-01-596-7270 015021 6515-01-596-6391 015026 6515-01-596-7077 015027 6515-01-596-6387 015028 FilterLine H Set, Adult / Paediatric Intubated sampling line and airway adapter for humid environments Smart CapnoLine Plus O2 Non-Intubated Oral/ Nasal sampling with O2 delivery for Adults FilterLine Set, Adult / Paediatric Intubated sampling line and airway adapter for short term monitoring VitaLine H Set, Adult / Paediatric Intubated sampling line and airway adapter for high ambient humidity Smart CapnoLine O2 Paediatric Non-Intubated Oral/ Nasal sampling with O2 delivery for Paediatrics FilterLine H Set, Infant / Neonate Intubated sampling line and airway adapter for humid environments, Infant/neonatal use 6.4.1 Getting started To use the Capnometer, lift the door covering the Capnometer connector. The door will either be resting or will be pushed closed (in which case it will be latched). Lift the door by gently pressing on the latch end of the door and then levering the door up. The door is spring-loaded and will provide a gentle resistance to your finger. Letting go of the door will allow it to snap-shut. The door can be latched shut by applying gentle pressure to the latch end of the door to push it in you will feel a click as the door latches. CAUTION The Capnometer door must be shut at all times when a cannula is not fitted. This is important to prevent dust, fluids or foreign objects from entering the Capnometer. Ensure the door is only kept open for the minimum time necessary to plug and unplug a cannula into the Tempus. CAUTION If the door snaps shut this will only provide functional protection against dust/fluids etc. to the Capnometer. For IP66 sealing the door must be pushed closed to engage the doors latch. If the Capnometer door is open the device has an IPX1 rating. CAUTION If the door is broken it must be replaced as soon as possible. The door and spring assembly can be removed and replaced with spare items by an appropriate technician without the unit being returned to RDT. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 105 Chapter 6 Taking medical readings CAUTION Allowing dust, fluids or foreign objects to enter the Capnometer can cause permanent damage to the device. With the door open, attach a suitable patient airway adaptor (cannula) to the Capnometer socket of the Capnometer. An adult nasal cannula is typically supplied but a range of cannulas and other adaptors are available. Twist the cannula clockwise to insert and counter clockwise to remove. When inserting, ensure the cannula is fully inserted by twisting it until it is finger-tight. CAUTION CAUTION Always ensure the cannula is fully inserted and fully tightened. Failing to tighten the cannula may result in the sample being diluted and an artificially low reading being produced. Below the hole for the cannula inlet is a small hole for the Capnometer exhaust. Take care not to block this hole (an error will be caused if it becomes blocked) and ensure that dust, fluids or foreign objects do not enter it. Note that the Capnometer is not suitable for connection to a gas scavenging system. Attach the cannula or airway adaptor to the patient following the instructions printed onto the pack of the adaptor. The Capnometer will start as soon as the probe is attached to the patient. Applying a FilterLine set The FilterLine set is intended for the CO2 monitoring of intubated patients. Before attaching the airway adapter to the breathing circuit, verify that the adapter is clean, dry and undamaged. Replace if necessary. Place the airway adapter at the proximal end of the airway circuit between the elbow and the ventilator circuit wye. Do NOT place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter. If pooling does occur, the airway adapter and sampling line must be replaced. Applying a Smart CapnoLine oral/nasal cannula The oral/nasal cannulas are intended for monitoring CO2 in non-intubated patients. Oral/nasal sampling cannulas are especially valuable for patients who are prone to mouth breathing, since most (if not all) of the CO2 is exhaled through the mouth. If a standard nasal CO2 sampling cannula is used on such patients, the ETCO2 values and capnogram displayed will be substantially lower than the actual CO2 levels present in the patients expired breath. Remove the cannula from the package. Verify that the cannula is clean, dry, and undamaged. Replace if necessary. 6.4.2 Taking readings Place the oral/nasal cannula onto the patient with two hands by first placing the prongs of the cannula into the patients nostrils, then extend the lengths of the cannula around both sides of the patients face routing the cannula tubing up to and then over both the patients ears. Proceed to loop the tubing around the back of the ears and bring the tubing under the ears and back towards where the patients chin and throat meet. Holding the tubes together with one hand under the chin, slide the collar around the cannula up so it secures both tubes of the cannula together firmly but comfortably under the patients chin CAUTION Dispose of Microstream ETCO2 consumables according to standard operating procedures or local regulations for the disposal of contaminated medical waste. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 106 The capnogram is shown continuously The Capnography Section of the Home Screen 6.4 Capnography The Respiration rate reading is shown here The ETCO2 reading is shown here Once the Capnometer is active it will run until the cannula is unplugged from the Tempus. Note that the wave speed of the capnogram is slower that the ECG and Pleth by default. Once the Capnometer is started it will display the message Warming up for approximately 30 seconds. ETCO2 readings will then display immediately and respiration readings will appear 2 breath cycles after the EtCO2 readings appear. If the Capnometer is sufficiently warm, it can take as little as 7 seconds to return an ETCO2 reading and 12 seconds to return a respiration rate reading (assuming a rate of >10 rpm). Once the Capnometer has started, check that the connections have been made properly by confirming the capnogram waveform appears correctly. Note If impedance respiration was in use, the waveform will automatically change to CAPNO and will display the end tidal CO2 as soon as the cannula is connected. As soon as the cannula is disconnected (and the consequent error is cleared) the device will resume monitoring using impedance respiration. After the Capnometer has started, it should draw a steady flow of breath gas down the cannula. If the cannula becomes blocked, the Capnometer will attempt to free the blockage by forcing low pressure air into the cannula. While this is occurring the waveform and readings will not be displayed and a message saying Capnometer filter line purging will be displayed in the waveform area. If the purging is successful then operation will resume automatically, if the blockage cannot be cleared (45 seconds approx.) then an error will be posted instructing to replace the cannula and the Capnometer will cease operation until the cannula is removed and replaced. 6.4.3 Capnometer settings Pressing anywhere in the capnogram area brings up the Capnometer settings menu:

Menu option Menu screen Respiration limits (rpm) set the upper and lower alarm limits for respiration. No breaths (sec) set the time that elapses after detection of no breaths until the alarm sounds. ETCO2 limits set the upper and lower alarm limits for ETCO2. ETCO2 units select mmHg or kPa. Wave range adjust respiration wave height and amplitude. Respiration wave speed (mm/s) set wave speed to 3.1, 6.25 or 12.5. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 107 Chapter 6 Taking medical readings Menu option Menu screen Operating mode to switch off the pump (for suction or lavage), select Pause 5 mins or Pause 10 mins. Note The ETCO2 units can be presented on the home screen in either mmHg or kPa but measurements in the Trends table and at i2i are only available in mmHg. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 108 6.5 Contact temperature 6.5 Contact temperature The thermometer is only intended for use with YSI series 400 sensors. Disposable and reusable 400 series sensors may be used. Do not use series 700 sensors with the Tempus. Application and use of metal-jacketed temperature sensors that come into contact with conductive objects or clinical personnel during electrocautery may cause burns at the patient-probe/electrode contact points. Always read and follow the instructions on the packaging of temperature sensors regarding their storage, use and disposal. In particular take into account any information regarding toxicity. The contact temperature probes must be attached to the parts of the body which their labelling shows they are indicated for. A single temperature channel (T1) is provided on the Tempus as standard. The second channel may be activated as an option using a software update. WARNING WARNING WARNING Note Note 6.5.1 Getting started To use the thermometer, plug a YSI series 400 temperature sensor into the Tempus socket marked T1. 6.5.2 Taking readings Attach the sensor to the patient following the instructions on the sensors packaging. The device will start to provide readings as soon as the sensor is connected (typically <10 seconds but up to 35 seconds according to IEC80601-2-56). Users should monitor the temperature to observe when the reading settles (settling time will be dependent on environmental and patient factors). Change the setting of the Tempus to C or F as required. Note Ensure the probe is suitably secured to the patient The difference between channels T1 and T2 is shown here The readings from channel T1 are shown here The reading from channel T2 are shown here Tempus Pro User/Operator Manual - 41-2001EN-00 Page 109 Chapter 6 Taking medical readings 6.5.3 Contact temperature settings Pressing anywhere on the contact temperature area brings up the contact temperature settings menu. Note The thermometer performs a self-check to 38.8 C 0.1 C constantly to ensure that its readings are accurate and within specification. If the Tempus Pro is configured to support only one temperature channel:

The values in the Temperature Settings screen apply regardless of whether the temperature sensor is connected to socket T1 or T2. The maintenance user can still configure default alarm limits for two channels (T1 and T2), but the T2 default alarm limits are ignored and the initial temperature limits in the Temperature Settings screen are equal to the T1 default alarm limits. The single channel Temperature Settings screen looks like this:

Menu option Menu screen Temperature units set the measurement units to C or F. Temp limits set the lower and upper temperature alarm limits. If the Tempus Pro is configured to support two channels of contact temperature:

There are separate configured alarm limits for the T1 and T2 channels. There is a configured alarm limit for the difference between T1 and T2 (Delta). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 110 The two-channel Temperature Settings screen looks like this:

Menu option Menu screen 6.5 Contact temperature Temperature units set the measurement units to C or F. T1 limits and T2 limits set the lower and upper temperature alarm limits for each channel. Delta limits set the delta temperature alarm limits, based on the difference between T1 and T2. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 111 Chapter 6 Taking medical readings 6.6 Invasive pressure WARNING WARNING WARNING WARNING WARNING WARNING WARNING DO NOT use the Invasive Pressure monitor for any purpose other than specified in this manual. If electrocautery is used, always avoid using any transducer with a conductive (metal) case connected to its ground shield. Using a conductive transducer that is connected to its cable shield risks high-frequency burns at the ECG electrodes if the transducer case becomes grounded to earth. Normal alarm functions will detect complete disconnections of invasive pressure transducers and faulty cables / transducers. Use only approved transducers and ensure that they are connected properly. Invasive Pressure is a tool to be used in addition to patient assessment. Care should be taken to assess the patient at all times. Do not touch metal parts of the transducer while it is in contact with the patient. Do not reuse any components that are labelled for single use only. Although complete disconnections of invasive pressure transducers will be detected by the normal alarm functions, partial disconnection will not be detected, nor will the use of some incompatible transducers. The user must exercise reasonable measures to ensure that approved transducers are used and that pressure transducers are connected properly. WARNING If electrocautery is used, always avoid using any transducer with a conductive (metal) case that is electrically connected to its cable shield. Using a conductive transducer case with such a shield connection risks high-frequency burns at the ECG electrodes if the transducer case becomes earth grounded. WARNING WARNING WARNING CAUTION CAUTION Always read and follow the instructions on the packaging of transducers regarding their storage, use and disposal. In particular take into account any information regarding toxicity. Remember to follow instructions provided with the transducers relating to use in defibrillation. Remember to differentiate the different transducers that are connected to the Tempus. The adaptor cables are labelled P1 & P2. The Tempus provides features to additionally label these channels with their site description on the display. Do not attempt to clean, disinfect, sterilize or in any way re-use transducers, catheters or other patient connected tubing which are labelled as single use only. Dispose of all single use items according to standard operating procedures or local regulations for the disposal of contaminated medical waste. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 112 6.6 Invasive pressure The invasive pressure meter will require warming up if it is started from cold. The warm up time is specified in section 14.1.6 Invasive pressure. Once the Tempus is turned on and the invasive pressure parameter functional, the pressure waveform will appear on the display. Check all cables and connections before use. Request that an appropriate service technician check the function of the device (including operation of all audible and visual alarms) on a regular basis. Note Note The Tempus is compatible with a range of invasive pressure sensors see 12.1.2 Invasive pressure accessories Always use the correct adaptor cable for the desired transducer to connect it to the Tempus. The Tempus provides two channels of invasive pressure which can be extended to four channels via a USB IP Module. The Tempus Pro can then be used with one, two, three or four transducers. 6.6.1 Getting started To measure invasive pressure, open the transducer packaging and inspect the transducer cable. If the cable shows signs of damage or wear, then replace it. Attach the transducer to the patient following the instructions supplied with the devices packaging. Attach the appropriate adaptor cable for the transducers you wish to use to the Tempus (white socket). Then connect the transducers to the cable, taking care to note and understand which transducer is attached to channel P1 and which to channel P2. 6.6.2 Taking readings Then zero the transducers using the process described in section 6.6.5 Zeroing transducers. WARNING Always zero the transducer before using it. Then attach the transducer to the patient following the instructions on the transducers packaging. Note The invasive pressure feature can be used to monitor a single channel at a time. In this case, either channel P1 or P2 can be used. See the example shown below where channel P2 is being used in isolation. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 113 Chapter 6 Taking medical readings The channel label is shown here The pressure waveform is shown here The Systolic, Diastolic and Mean measurements are shown here Once a second channel of invasive pressure is in use, it will appear as shown below. The second channel will appear here Note that the pulse oximetry readings move to here Monitoring two channels of invasive pressure Note If a second channel of invasive pressure is used, this channel will replace the pulse oximeters results and plethysmogram in the results layout. The pulse oximeter results will move to the right into the previously unoccupied area. As soon as the either of the invasive pressure channels stop being used (when the transducer is disconnected from the adaptor cable and the alarm ceased), the pulse oximeter results and plethysmogram will return to their original location. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 114 6.6 Invasive pressure 6.6.3 Invasive pressure settings Pressing anywhere on the invasive pressure area brings up the invasive pressure settings menu. CAUTION The settings of each invasive pressure channel can be set differently. Press on the area of the relevant channel to access its settings. Changes in settings made to one channel are never automatically made to any other channel. Menu option Menu screen The title bar shows the channel being configured (P1 in this example). Channel configuration label and reconfigure the channel, see 6.6.4 Configuring the transducer / channel. Zero transducer zero the transducer, see 6.6.5 Zeroing transducers. Systolic limits, Mean limits and Diastolic limits set the lower and upper alarm limits. Cardiac wave speed (mm/s) change wave speed. This setting is common to ECG, Sp02 and IP. Various conditions can affect the performance and accuracy of the invasive pressure measurement. These include:

Clogging of the catheter. The placement of the catheter in the vasculature. Artefact such as catheter whip should be managed according to whatever clinical protocols are in place locally. The position of the transducer stopcock, catheter and flush port. The position of the transducer with respect to the patients haemostatic axis or the catheter tip. Patient movement. Saline line flushes which may temporarily interrupt accurate pressure measurement. Air bubbles in the catheter or in the transducer dome. CAUTION Flush the catheter regularly while taking invasive pressure measurements. Always view the waveform to endure that pressure measurements are based on a physiological waveform. 6.6.4 Configuring the transducer / channel Each channel can be configured according to its application. By default, both channels will appear in white, with results configured as S, M and D with a default scale (height) of the channel waveforms being 0-150 mmHg. Accessing the Channel Configuration menu allows the channel labels to be individually named, the results format to be re-configured and the channel height to be adjusted. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 115 Chapter 6 Taking medical readings The channel is labelled here Press here to select the label and type of the channel Press here to change the format of the measurement Press to change the scale (height) of the channels waveform this can be changed independently of the default setting The full description of the selected channel label will be shown here e.g. Arterial Blood Pressure Press here to save the changes made changes will not be made unless Save is pressed Configuring an Invasive Pressure Settings Menu CAUTION The settings of each invasive pressure channel can be set differently. Changes in settings made to one channel are never automatically made to any other channel. The menu allows the user to pick pre-set labels for the channel. These are grouped by colour and application with RED being for arterial labels, BLUE being for venous labels, PALE YELLOW for pulmonary arterial pressure and WHITE being for other application labels. Simply picking a label and then pressing Save will change the channel label and the colour of the waveform and results. It will also change the waveform height and the Reading format and alarm limits. If a label is changed from one type to another (e.g. from an arterial to a venous pressure), the reading format and waveform upper and lower limits will be set to defaults for the selected label. If a label is changed but stays within the same type (e.g. from ART to AO), any non-default reading format or waveform upper / lower limits will persist. The default settings are detailed below. For default alarm limits and alarm ranges, see 7.3 Patient alarms. Note Note Label Labelled channels will keep their labelling until either the patient is discharged, switched to previous patient or if the user manually changes the channel label. If an invasive pressure channel is labelled as Arterial and the critical alarm sounds pressing the alarm buttons will automatically set that channel to zero required. Application Colour Reading format Waveform height ART Arterial Blood Pressure BAP Brachial Artery Pressure RAP Radial Artery Pressure AO Aortic pressure Arterial Arterial Arterial Arterial FAP Femoral Artery Pressure Arterial UAP Umbilical Artery Pressure Arterial ABP Abdominal Aorta Pressure Arterial LAP Left Atrial Pressure Arterial Red Red Red Red Red Red Red Red S/D (m) S/D (m) S/D (m) S/D (m) S/D (m) S/D (m) S/D (m) S/D (m) 0-150 mmHg 0-150 mmHg 0-150 mmHg 0-150 mmHg 0-150 mmHg 0-150 mmHg 0-150 mmHg 0-150 mmHg Tempus Pro User/Operator Manual - 41-2001EN-00 Page 116 6.6 Invasive pressure Label Application Colour Reading format Waveform height CVP Central Venous Pressure Venous UVP Umbilical Venous Pressure Venous Blue Blue

(M) S/D

(M) S/D PAP Pulmonary Artery Pressure Pulmonary Pale yellow S/D (m) artery ICP Intra-Cranial Pressure Intra-cranial White BDR Bladder Pressure Bladder White M M 0-30 mmHg 0-30 mmHg 0-50 mmHg 0-50 mmHg 0-30 mmHg The reading format can be changed independently of the default settings. The reading can be formatted to read Systolic, Mean and Diastolic readings in the following orders:

S/D (m) where Systolic and Diastolic are shown in larger font and the mean is shown in brackets in a smaller font.

(M) S/D where Mean is shown first in brackets and the Systolic and Diastolic are then shown in a similar font. M where only the Mean is shown. When this setting is chosen (M only), Systolic and Diastolic alarming will be disabled for that channel. The scale (height) of the channel waveform can be changed independently of the default settings. The scale can be formatted to read from -99 mmHg to 310 mmHg in pre-set levels. Note Users should review the default alarm and parameter settings and decide if these are compatible with the clinical protocols in place locally for attended and unattended monitoring of patients and make any procedural changes required in light of this review. 6.6.5 Zeroing transducers WARNING Always zero the transducer before using it. Note Note You can re-zero the transducer as often as required. If the transducer is disconnected from the cable, ensure a pause of at least 5 seconds is maintained before reconnecting the transducer (or before connecting a new transducer). Always zero a transducer after it has been it is connected to the Tempus (before use). The invasive pressure transducers must be zeroed to ensure they provide accurate measurements. If a transducer is changed or moved, it must be zeroed again. Follow the instructions on the transducers packaging while following the zeroing process detailed below. The transducer should be placed at the same height as the patients left atrium before and during the zeroing process. To zero, first close the transducer stopcock to the patient. Then open the transducers venting stopcock to atmosphere. Allow the transducer a few seconds to settle. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 117 Chapter 6 Taking medical readings 1. Ensure you are zeroing the correct channel 2. Press here to zero the transducer 3. A zeroing message will appear here this lasts a few seconds 4. Once the zero has been achieved, the text will update to confirm the time the zero was performed Zeroing the transducer Remember to zero the channel/transducer that you are using. Take care to differentiate between the two transducers and their settings. CAUTION If the process fails to measure a valid zero reading, check the transducer stop cock is open to atmospheric air and correctly connected to the Tempus. Then repeat the process. Replace the transducer if the error recurs. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 118 6.6.6 Two channel USB invasive pressure module 6.6 Invasive pressure 2 Channel USB IP Module Connected to the Tempus Pro 2 Channel IP Module When the 2 channel USB IP Module is plugged into the Tempus Pro USB socket and a patient cable and transducers are connected, channels 3 and 4 of will appear as shown below. For part number details, see 12 Accessories list of the Tempus Pro. For specification details for the module, see 14 Specifications and standards. The USB module employs the same technology as the Tempus Pros internal Invasive Pressure measurement technology and therefore the same warnings, cautions and notes should be adhered to. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 119 Chapter 6 Taking medical readings Four channel invasive pressure display If four channels of invasive pressure are used, the third invasive pressure channel replaces the capnometer waveform and the fourth invasive pressure channel replaces the NIBP display:

Fourth invasive pressure channel

(numeric) Third invasive pressure channel Four Channels of Invasive Pressure results page Note Note Note If a fourth channel of invasive pressure is used, NIBP becomes unavailable and measurements are stopped. If you disable one of the four invasive pressure channels, the display reverts to three channel format (see below). If you disable two of the four channels, the capnometer waveform and NIBP results will return to their original location. The invasive pressure channels will always be displayed in numerical order on the results page, even if you plug in channel three and four before one and two. You can change which 3 of the 4 channels are displayed as waveforms by selecting if a waveform is required or not for that channel in the channel settings. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 120 Three channel invasive pressure display If three channels of invasive pressure are used, the third invasive pressure channel replaces the capnometer waveform and the NIBP is displayed in short form:

6.6 Invasive pressure NIBP short form display

(in this example, NIBP is active) Third invasive pressure channel Three Channels of Invasive Pressure results page If NIBP is active, the short form display does not include a Start button or a timer icon. To take a new NIBP reading without waiting for the auto-timer period, or to take a reading when in manual mode, press the NIBP display area and use the Start button at the top of the NIBP Settings menu. If you disable one of the three invasive pressure channels, the capnometer waveform and NIBP results will return to their original location. Note Note Tempus Pro User/Operator Manual - 41-2001EN-00 Page 121 Chapter 6 Taking medical readings Tempus Pro User/Operator Manual - 41-2001EN-00 Page 122 7 Alarms The Tempus produces both patient (physiological) alarms and technical alarms. Patient alarms are user configurable but technical alarms are not. Patient alarm settings are reset to factory defaults when a new patient is admitted or if you switch back to monitor a previous patient. If you turn the Tempus off and on and select to continue monitoring, the alarm settings will be retained (if the off period is less than 30 seconds) and the Tempus will revert to currently used settings. Default alarm values will differ across different patient ages (adult, paediatric, and neonate) see 7.3 Patient alarms. Note that default alarms are configurable by the operating institution. WARNING WARNING WARNING WARNING CAUTION Do not silence the audible alarm if patient safety may be compromised. Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditions. Before each use, verify that the alarm limits are appropriate for the patient being monitored. Check the audible alarm silence duration before temporarily silencing the audible alarms. In high-altitude environments, EtCO2 values may be lower than values observed at sea level, as described by Dalton's law of partial pressures. When using the monitor in high altitude environments, it is advisable to consider adjusting EtCO2 alarm settings accordingly. All alarms are non-latching i.e. the audible and visual alarm indicators will cease when the alarm condition ceases to exist. For example, if the heart rate goes from 80 to 105 and the alarm threshold has been set to 100, then both visual and audible alarms will be generated, when the heart rate drops below 100 the visual and audible alarms will cease automatically. Alarms are audible in a 360 direction from the Tempus, however users should note that alarm volume will be loudest when the user is positioned facing the Tempus. Moving to the side or rear of the Tempus will produce quieter alarm volumes. Alarm volumes are specified at 1m from the front of the device. The visual alarms are visible in a 360 direction around the Tempus. However, users should note that alarms will be most visible from the front of the device. While the alarms are visible from the sides (via light dispersed in the handle) and the rear, the visibility of the alarms is reduced in these positions. The normal operating position of the operator should take into account the ability to see and hear the alarm signals taking into account local light and noise levels. The alarm bar and the audible alarm will operate briefly soon after start up. Ensure both functions are operating before using the device. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 123 Chapter 7 Alarms WARNING If relying on the alarms, ensure that the display and alarm bar are viewable from the users operating position. Ensure the handle and rear alarm light remain clean and unobstructed. Ensure the alarm speaker remains unobstructed and alarm volume is set to a level appropriate to the level of background noise expected. WARNING WARNING WARNING WARNING WARNING The alarm functions of the Tempus are intended to be used by the attendant user only. If the device is connected to a Response Centre this is for the purpose of sharing vital signs data in real time, between two users for the purpose of obtaining additional clinical support. The system is not a distributed alarm system (e.g. nurse monitoring station system) in the terms of IEC60601-1-8. The i2i system at the Response Centre is not equipped with alarm silencing or suspending controls. When connected to a PC running the i2i application at a Response Centre, streamed data, such as the waveforms displayed on the Tempus Pro, will be transmitted and displayed automatically on that PCs display. Users are advised that streamed data are transmitted using the UDP protocol. The UDP protocol includes error checking but does not retransmit data. Therefore, any data that is dropped, lost or delayed during the streaming process will not be retransmitted. In the event that packets of waveform data are lost, they will appear as gaps in the waveform that is displayed on the i2i interface. Medical data (vital signs data, photos, ECG recordings, patient details, TCCC cards etc.) are transmitted using TCP/IP, this includes error checking and retransmission so missing or dropped packets are therefore retransmitted. Too many of the same or similar pieces of equipment in an area, with different alarm pre-sets, may make it difficult for the operator to know how the alarm system will operate. Users should check to ensure that any alarm setting is appropriate prior to use. CAUTION Ensure alarm values are not changed to extreme levels simply to disable the alarms system. Ensure alarm levels are brought into a more sensitive state for severe or critical patients or for patients who will be left unattended. CAUTION The Tempus alarms are intended to alert attendant users. They are not intended to alert users who remove themselves from the patients vicinity. Users should consider the levels of background ambient noise and light if they will not be in close proximity to the patient. The alarms provided by the system do not replace user care. Note Note Users are reminded to ensure the alarm speaker is working every time they use the product. This can be verified by simply using the touchscreen if the speaker is working then audible feedback will be given for each press of the screen. The Tempus will not report any alarm for the first 10 seconds after a sensor is attached. This is to prevent false positive alarms being generated due to patient/user/sensor artefact that can be commonly caused while a parameters sensor is first fixed to the patient. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 124 7.2 Visual alarm characteristics 7.1 Audible alarm characteristics The Tempus provides audible alarm indications through a speaker mounted on the front of the device. WARNING If relying on the alarms, ensure that the display and alarm bar are viewable from the users operating position. Ensure the handle and rear alarm light remain clean and unobstructed. Ensure the alarm speaker remains unobstructed and alarm volume is set to a level appropriate to the level of background noise expected. CAUTION Do not attempt to clean beneath the grille with a sharp or rough implement; this can damage the water-proof sealing that is present beneath the grille and cause reduction or impairment of the ingress protection barrier. Audible alarms are separated into either patient (physiological) alarms or inop (technical) alarms. These alarm signals are specified as follows:

Nominal Characteristics Patient Alarm (Red) Patient Alarm (Yellow) Technical Alarm Pulse sequence 10 x 175 ms pulses 3 x 125 ms pulses at 440 Hz

(with 4 harmonics under 4 kHz) 2 x 250 ms pulses Repetition rate Every 10 seconds Every 5 seconds Every 15 seconds Duration of gap between pulse sequences 50 ms silence between pulses 1 and 2, 2 and 3, 4 and 5, 6 and 7, 7 and 8, 9 and 10. 170 ms silence between pulses 3 and 4, 8 and 9. 625 ms silence between pulses 5 and 6 250 ms silence between pulse sequences 250 ms silence between pulse sequences Volume (dBA at 1 m) 85 dBA (default) the volume may be reduced using the All Alarms menu Alarm Volume settings: Min, Low, Mid and High. 7.2 Visual alarm characteristics When alarms occur, the Tempus Pro indicates their presence in the following ways:

Alarm bar LEDs:

the yellow or red LEDs in the alarm bar will light these flash for patient alarms and light solid (yellow) for technical alarms Alarm status area:

summary description of the alarm is shown here Alarm limits bar:

the parameter that is alarming is highlighted with a solid yellow or red bar here (patient alarms only) Visual Alarm Manifestations Tempus Pro User/Operator Manual - 41-2001EN-00 Page 125 Chapter 7 Alarms 7.2.1 Alarm bar LEDs The alarm bar LEDs illuminate in one of the following ways:

Flashing yellow LED (for patient alarms);

Solid yellow (for technical alarm);

Flashing red (for specific high priority alarms). CAUTION The alarm bar can also be user-configured to show a solid green LED to indicate no active alarms (this feature is enabled and disabled in the Maintenance Menu, refer to the Tempus Pro Maintenance Manual for details). 7.2.2 Alarm status area For both patient and technical alarms, the Tempus shows the alarm symbol and a description of the alarm in the alarm status area at the top right of the display. CAUTION Note In strong daylight users should ensure that the alarm status area is visible. If multiple alarms occur, they will be displayed in rotation in the alarm status area. Press the alarm status area to view a list of all active alarms and to select technical alarms for clearing see 7.7 Viewing and clearing alarms. Active patient alarms look like this Alarm Status Area Patient Alarm Tempus Pro User/Operator Manual - 41-2001EN-00 Page 126 7.2 Visual alarm characteristics Active technical alarms look like this Alarm Status Area Technical Alarm When there is no alarm state, the alarm bar will display the time of the last patient alarm or No Alarms Active if there have not been any alarms. This shows that no alarms are active Alarm Status Area with no alarms active 7.2.3 Alarm limits bar For patient alarms only, on the Home screen, the Tempus highlights the alarm limits bar for the parameter that is alarming. It is highlighted in a solid (not flashing) yellow. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 127 Chapter 7 Alarms Alarm limits bar for the parameter that is alarming Alarm Limits Bar 7.2.4 Bottom status bar For patient alarms only, on screens that have a bottom status bar, the Tempus highlights the parameter that is alarming in flashing white text on an orange background. The reading is shown in white text on an orange background to indicate that the value is outside limits Reading outside Limits Tempus Pro User/Operator Manual - 41-2001EN-00 Page 128 7.3 Patient alarms 7.3 Patient alarms The table below lists all patient alarms:

Parameter Measurement Range Patient type Default Alarm Low Alarm Low Range Default Alarm High Alarm High Range ECG Heart rate 30-300 bpm Adult 50 bpm 30-238 bpm 120 bpm 32-239 bpm 30-300 bpm Paediatric 50 bpm 30-238 bpm 150 bpm 32-239 bpm 30-300 bpm Neonate 100 bpm 30-238 bpm 200 bpm 32-239 bpm ST

-50 - +50 mm Adult

-2.0 mm

-10 +2 mm

+2.0 mm N/A N/A QT 1 2000 ms Adult PI PVI N/A N/A 0-20%

0-20%

0-20%

0-100%

0-100%

0-100%

Paediatric N/A Neonate N/A N/A Paediatric N/A Neonate N/A N/A N/A N/A N/A N/A Adult OFF Off, 0.1 to 18 Paediatric OFF Off, 0.1 to 18 Neonate OFF Off, 0.1 to 18 Adult 5%

Paediatric 5%

Neonate 5%

Off, 1 to 98 Off, 1 to 98 Off, 1 to 98 SpOC 0 to 35 ml/dl Adult 10 ml/dl Off, 1 to 33 0 to 35 ml/dl Paediatric 10 ml/dl Off, 1 to 33 0 to 35 ml/dl Neonate 10 ml/dl Off, 1 to 33 SpO2 pulse rate 25-239 bpm Adult 50 bpm 30-238 bpm 120 bpm 32-239 bpm 25-239 bpm Paediatric 50 bpm 30-238 bpm 150 bpm 32-239 bpm 25-239 bpm Neonate 100 bpm 30-238 bpm 200 bpm 32-239 bpm Impedance respiration 3-150 rpm Adult 5 rpm 3-145 rpm 3-150 rpm Paediatric 5 rpm 3-145 rpm 3-150 rpm Neonate 12 rpm 3-145 rpm SpO2 SpCO SpHb 0-100%

0-100%

0-100%

0-99%

0-99%

0-99%

0-25 g/dl 0-25 g/dl Adult 90%

Paediatric 90%

Neonate Adult 85%

OFF Paediatric OFF Neonate OFF 50-98%

50-98%

50-98%

1-97%

1-97%

1-97%

Adult 7.0 g/dl 1.0-23.5 g/dl 17.0 g/dl 2.0-24.5 g/dl Paediatric 7.0 g/dl 1.0-23.5 g/dl 17.0 g/dl 2.0-24.5 g/dl Tempus Pro User/Operator Manual - 41-2001EN-00 Page 129

-2 +10.0 mm N/A N/A 10 1990 ms N/A N/A 0.2 to 19, Off 0.2 to 19, Off 0.2 to 19, Off 2 to 99, Off 2 to 99, Off 2 to 99, Off 2 to 34, Off 2 to 34, Off 2 to 34, Off N/A N/A 500 ms N/A N/A OFF OFF OFF 40%

40%

40%

25 ml/dl 25 ml/dl 25 ml/dl 30 rpm 30 rpm 80 rpm 100%

100%

95%

10%

10%

10%

5-149 rpm 5-149 rpm 5-149 rpm 52-100%

52-100%

52-100%

2-98%

2-98%

2-98%

Chapter 7 Alarms Parameter Measurement Range Patient type Default Alarm Low Alarm Low Range Default Alarm High Alarm High Range 0-25 g/dl Neonate 7.0 g/dl 1.0-23.5 g/dl 17.0 g/dl 2.0-24.5 g/dl SpMet 0.0-99.9%

Adult OFF 0.0-99.9%

Paediatric OFF 0.0-99.9%

Neonate OFF 0.1-99.0 %

0.1-99.0 %

0.1-99.0 %

Capnometer respiration 1-149 rpm Adult 5 rpm 2-145 rpm 1-149 rpm Paediatric 5 rpm 2-145 rpm 1-149 rpm Neonate 12 rpm 2-145 rpm 3.0%

3.0%

3.0%

30 rpm 30 rpm 80 rpm 1.0-99.5 %

1.0-99.5 %

1.0-99.5 %

5-149 rpm 5-149 rpm 5-149 rpm Capnometer respiration no breaths detected

-

-

-

Adult 30 seconds 10-60 seconds

-

Paediatric 30 10-60 seconds

-

Neonate seconds 30 seconds 10-60 seconds

-

-

-

-

Capnometer ETCO2 0-150 mmHg 0-20 kPa Adult 25 mmHg 3.3 kPa 0-145 mmHg 0-19.3 kPa 0-150 mmHg 0-20 kPa 0-150 mmHg 0-20 kPa Paediatric 25 mmHg 3.3 kPa 0-145 mmHg 0-19.3 kPa Neonate 25 mmHg 3.3 kPa 0-145 mmHg 0-19.3 kPa 60 mmHg 8 kPa 60 mmHg 8 kPa 60 mmHg 8 kPa 5-150 mmHg 0.7-20 kPa 5-150 mmHg 0.7-20 kPa 5-150 mmHg 0.7-20 kPa Non-

Invasive Blood Pressure -

Systolic Non-

Invasive Blood Pressure -

Diastolic Non-

Invasive Blood Pressure -

Mean 40-260 mmHg Adult 90 mmHg 40-255 mmHg 160 mmHg 40-230 mmHg Paediatric 70 mmHg 40-155 mmHg 120 mmHg 40-130 mmHg Neonate 40 mmHg 40-125 mmHg 90 mmHg 20-200 mmHg Adult 50 mmHg 20-195 mmHg 90 mmHg 20-160 mmHg Paediatric 40 mmHg 20-155 mmHg 70 mmHg 20-100 mmHg Neonate 20 mmHg 20-95 mmHg 60 mmHg 26-220 mmHg Adult 60 mmHg 26-215 mmHg 110 mmHg 26-183 mmHg Paediatric 50 mmHg 26-155 mmHg 90 mmHg 26-110 mmHg Neonate 24 mmHg 26-155 mmHg 70 mmHg 45-260 mmHg 45-160 mmHg 45-130 mmHg 25-200 mmHg 25-160 mmHg 25-100 mmHg 30-220 mmHg 30-160 mmHg 25-160 mmHg Contact temperature 20-45 C / 68-

113 F Adult 35C /

95F 20-45 C / 68-

113 F 20-45 C / 68-

113 F Paediatric 35C /

Neonate 95F 35C /

95F 20-44 C / 68-

111 F 20-44 C / 68-

111 F 20-44 C / 68-

111 F 37.8 C /

100 F 37.8 C /

100 F 37.8 C /

100 F 21-45 C /

69.8-113 F 21-45 C /

69.8-113 F 21-45 C /

69.8-113 F Tempus Pro User/Operator Manual - 41-2001EN-00 Page 130 Parameter Measurement Range

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg Invasive Pressure Systolic Arterial Invasive Pressure Diastolic Arterial Invasive Pressure Mean Arterial Invasive Pressure Systolic Venous Invasive Pressure Diastolic Venous Invasive Pressure Mean Venous Invasive Pressure Systolic PAP Invasive Pressure Patient type Default Alarm Low Adult 90 mmHg Paediatric 70 mmHg Neonate 40 mmHg Adult 50 mmHg Paediatric 40 mmHg Neonate 20 mmHg Adult 60 mmHg Paediatric 50 mmHg Neonate 24 mmHg Adult 6 mmHg Paediatric 2 mmHg Neonate 2 mmHg Adult

-4 mmHg Paediatric

-4 mmHg Neonate

-4 mmHg Adult 0 mmHg Paediatric 0 mmHg Neonate 0 mmHg Adult 10 mmHg Paediatric 24 mmHg Neonate 24 mmHg Adult 0 mmHg Alarm Low Range

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg Default Alarm High 160 mmHg 120 mmHg 90 mmHg 90 mmHg 70 mmHg 60 mmHg 110 mmHg 90 mmHg 70 mmHg 14 mmHg 10 mmHg 10 mmHg 6 mmHg 2 mmHg 2 mmHg 10 mmHg 4 mmHg 4 mmHg 34 mmHg 60 mmHg 60 mmHg 16 mmHg 7.3 Patient alarms Alarm High Range

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg Tempus Pro User/Operator Manual - 41-2001EN-00 Page 131 Chapter 7 Alarms Parameter Measurement Range

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg Diastolic PAP Invasive Pressure Mean PAP Invasive Pressure Mean ICP Invasive Pressure Mean BDR Patient type Default Alarm Low Paediatric

-4 mmHg Neonate

-4 mmHg Adult 0 mmHg Paediatric 12 mmHg Neonate 12 mmHg Adult 0 mmHg Paediatric 0 mmHg Neonate 0 mmHg Adult

-

Paediatric

-

Neonate

-

Alarm Low Range

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg Default Alarm High

-4 mmHg

-4 mmHg 20 mmHg 26 mmHg 26 mmHg 10 mmHg 4 mmHg 4 mmHg 10 mmHg 10 mmHg 10 mmHg Alarm High Range

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg

-99 310 mmHg All patient alarms are medium priority alarm states as defined by IEC60601-1-8 with the exception of ECG arrhythmias and catheter disconnected for invasive pressure (mean arterial pressure only). In this event if the catheter pressure drops from a value of greater than 10 mmHg to less than 10 mmHg and remains there for a period longer than that specified in the table in section 7, then the red alarm bar LED will flash and a high priority alarm tone will be emitted. 7.4 Technical alarms Technical alarms can relate to the state of the Tempus itself or its connection to the patient. Technical alarms are low priority alarm states as defined by IEC60601-1-8. The majority of technical alarms are self-explanatory and should be addressed by following the on-screen instructions. Additional information is provided below for certain technical alarm conditions. Technical alarms can be cleared by the operator see 7.7 Viewing and clearing alarms. Condition On-Screen Error Text Comment Bluetooth linking error Attention - Bluetooth Unable to initialize Bluetooth. If the problem persists, use a wired headset. Communications error cable not plugged in Attention - Data Cable The data cable is not plugged in correctly. Communications notification Attention - Data Connecting Initialising data encryption engine. Repeat the process taking care to follow on-screen and written instructions Repeat the process taking care to follow on-screen and written instructions No action initialisation process lasts <15 seconds Tempus Pro User/Operator Manual - 41-2001EN-00 Page 132 7.4 Technical alarms Condition On-Screen Error Text Comment Communications error connection failed Attention - Data Connection The data link was unable to connect at this time. Repeat the process taking care to follow on-screen and written instructions Data export option Attention - Data Export There is patient record data from other devices/times. Do you want to over-write it?

GPS error Attention - GPS A GPS location has not yet been obtained;

leave the GPS on and check this screen again in a few minutes. Respond to instruction by pressing the appropriate on-

screen button option Repeat the process taking care to follow on-screen and written instructions Bluetooth headset linking error Attention - Headset The headset has not linked to the Tempus. Repeat step 3 of the instructions. Repeat the process taking care to follow on-screen and written instructions Low battery Attention - Low Battery Battery charge 25%, please connect the charger. Low battery Attention - Low Battery Battery charge 10%, please connect the charger. USB devices are disabled. Low battery Attention - Low Battery The battery is almost empty, USB devices are disabled. Patient switching error Attention Switch To A Previous Patient To switch patient you must first stop monitoring the current patient. Temporary notice follow onscreen instructions. Find another power source if available. Temporary notice follow onscreen instructions. Find another power source if available. Temporary notice follow onscreen instructions. Find another power source if available. Disconnect leads from the current patient before discharging/admitting a new patient Voice connection not possible, a data connection must be made first Attention - Voice Connection Headset voice connection will be started after connecting data. Repeat the process taking care to follow on-screen and written instructions Voice connection error Attention - Voice Connection The voice link was unable to connect at this time. WiFi connection error Attention - WiFi WiFi was unable to connect at this time. If the problem persists restart the Tempus and attempt the connection again. WiFi not activated Warning - WiFi WiFi is not activated on this device GSM not activated Warning GSM (Cell-phone) GSM is not activated on this device Bluetooth pairing error Bluetooth Pairing Error The required Bluetooth device not found Repeat the process taking care to follow on-screen and written instructions Repeat the process taking care to follow on-screen and written instructions Refer to the maintenance manual. Refer to the maintenance manual. Repeat the process taking care to follow on-screen and written instructions Tempus Pro User/Operator Manual - 41-2001EN-00 Page 133 Chapter 7 Alarms Condition On-Screen Error Text Comment Bluetooth pairing error Bluetooth Pairing Error Entered PIN is incorrect Bluetooth pairing error Warning - Bluetooth Bluetooth is not activated on this device. System error Internal Fault Detected A fault has been detected. Reason:

exception. The Tempus will need to restart. If this problem persists please contact your supplier. System error Internal Fault Detected A fault has been detected. Reason: file open error. The Tempus will need to restart. If this problem persists please contact your supplier. System error Internal Fault Detected A fault has been detected. Reason: file read error. The Tempus will need to restart. If this problem persists please contact your supplier. System error Internal Fault Detected A fault has been detected. Reason: file write error. The Tempus will need to restart. If this problem persists please contact your supplier. System error Internal Fault Detected A fault has been detected. Reason:cOS exception. The Tempus will need to restart. If this problem persists please contact your supplier. IP address error Invalid IP Address Please check the IP Address is in the format x.x.x.x and multiple addresses

(maximum of 3) are separated by ';'. Repeat the process taking care to follow on-screen and written instructions Repeat the process taking care to follow on-screen and written instructions Log the exact details of the fault so they can be communicated to the supplier. Log the exact details of the fault so they can be communicated to the supplier. Log the exact details of the fault so they can be communicated to the supplier. Log the exact details of the fault so they can be communicated to the supplier. Log the exact details of the fault so they can be communicated to the supplier. Correct the format of the IP address Network Settings Error Network Settings Error Enter network settings Software update error Options Key Check Failed There are no network settings in this mode. Low ambient temperature warning One or more option key checks have failed. Some features may be disabled. If the problem persists contact the service representative. Temperature Warning The device temperature is low, Tempus may shutdown. A software upgrade may have occurred incorrectly. Log the exact details of the fault so they can be communicated to the supplier. Attempt to warm the device and then restart Tempus Pro User/Operator Manual - 41-2001EN-00 Page 134 7.5 Setting alarms Condition On-Screen Error Text Comment USB connection error USB - Connection The USB memory stick is not plugged into the Tempus USB socket, please plug in. If plugged in, check it's the USB and not the RJ45 socket. Remove and re-insert the stick into the USB socket USB error USB - Connection Failed to connect with USB, please retry. USB error USB - Import The USB memory stick is empty; there is no handover data on it. USB error USB - Import The data on the USB memory stick was exported for the current patient. You cannot re-import this data. Remove and re-insert the stick into the USB socket Use the correct stick or ensure the files are on the stick you have You are attempting to re-write the current patient record with itself, this cannot be done Maintenance notification Warning - Settings Reset settings as required iAssist and Technical alarms are low priority alarm states as defined by IEC60601-1-8. Settings were not saved at power down and have been reset to defaults. 7.5 Setting alarms Alarm limits are set in either the individual parameter settings menu (accessible by pressing on that parameter area on the touchscreen) or through the All Alarms Menu (accessible from the main menu and parameter settings menus). 7.5.1 Default alarm settings It should be noted that all patient alarms have a user configurable delay of 0-8 seconds (4 seconds default, 0 seconds minimum) to help prevent spurious alarms being generated see 7.5 Setting alarms. In addition to this user-configurable time, the Tempus will produce alarms after the durations specified below. Alarm Nominal Time to Delay (Excluding User Configurable Delay) ECG heart rate high ECG heart rate low 2 seconds 2 seconds ECG heart rate out of range (low) 4 seconds (*) Pulse rate (from Oximeter) high Pulse rate (from Oximeter) low 3 seconds 3 seconds Pulse rate (from Oximeter) out of range (low) 4 seconds Pulse rate (from Oximeter) out of range (high) 4 seconds SpO2 high SpO2 low SpHb low 3 seconds 3 seconds 2 seconds Tempus Pro User/Operator Manual - 41-2001EN-00 Page 135 Chapter 7 Alarms Alarm SpHb high SpMet low SpMet high SpCO low SpCO high PI low PI high PVI low PVI high SpOC low SpOC high ETCO2 high ETCO2 low Respiration rate (from Capnometer) high Respiration rate (from Capnometer) low Respiration rate (from ECG) high Respiration rate (from ECG) low Nominal Time to Delay (Excluding User Configurable Delay) 2 seconds 2 seconds 2 seconds 3 seconds 4 seconds 2 seconds 2 seconds 2 seconds 2 seconds 2 seconds 2 seconds 4 seconds 4 seconds 4 seconds 4 seconds 4 seconds 4 seconds Capnometer no breaths detected 10 - 60 seconds (depending on delay setting) Non-invasive blood pressure systolic high 0 seconds at end of measurement Non-invasive blood pressure systolic low 0 seconds at end of measurement Non-invasive blood pressure mean high 0 seconds at end of measurement Non-invasive blood pressure mean low 0 seconds at end of measurement Non-invasive blood pressure diastolic high 0 seconds at end of measurement Non-invasive blood pressure diastolic low 0 seconds at end of measurement Contact temperature low Contact temperature high Invasive pressure systolic high Invasive pressure systolic low Invasive pressure diastolic high Invasive pressure diastolic low Invasive pressure mean low Invasive pressure mean high 4 seconds 4 seconds 4 seconds 4 seconds 4 seconds 4 seconds 4 seconds 4 seconds ECG monitoring arrhythmia - Extreme Brady 6 seconds (*) ECG monitoring arrhythmia - Extreme Tachy ECG monitoring arrhythmia - Vent Tachy ECG monitoring arrhythmia - Vent Fib ECG monitoring arrhythmia - Asystole 7 seconds 5 seconds 9 seconds 6 seconds Tempus Pro User/Operator Manual - 41-2001EN-00 Page 136 7.5 Setting alarms Alarm QT Alarm ST Alarm Nominal Time to Delay (Excluding User Configurable Delay) 60 seconds 60 seconds

(*) The user configurable delay is not applicable to this alarm 7.5.2 All alarms menu CAUTION The Reset to defaults button resets the following to their new patient default values: all alarm limits, Alarm trigger delay (Alarm suspend time), Alarm silence time, NIBP mode, NIBP adult inflation, NIBP paediatric inflation, NIBP neonate inflation, HR/PR source, Pacemaker indication, Arrhythmia analysis, ST/QT analysis, Monitoring filter, 12-lead filter and ECG power filter. Menu option Menu screen Alarm trigger delay set a delay time to help prevent spurious alarms. Range is 0-8 seconds (4 seconds default, 0 seconds minimum). Alarm volume select Low, Mid or High volume. Waveform snapshot on alarm turn this feature on or off. Alarm silence time set the time period in which audible alarms will be silenced when the Alarm Silence button is pressed. The available range is from 30 seconds up to the maximum value set in the Maintenance Menu. All alarms on activate all alarms (present on all pages of this menu). Reset to defaults - reset all alarm limits and other parameters to their new patient default values. Heart rate limits set alarm limits. ST1 limits set alarm limits. ST2 limits set alarm limits. QT upper limit set alarm limit. ECG Alarms turn ECG alarms off or on. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 137 Chapter 7 Alarms Menu option Menu screen SpO2 limits set alarm limits. SpHb limits set alarm limits. SpCO limits set alarm limits. SpMet limits set alarm limits. SpOC limits set alarm limits. Pulse ox. Alarms turn pulse ox. alarms off or on. PI limits set alarm limits. PVI limits set alarm limits. ETCO2 limits set alarm limits. Capno no breaths set alarm limit. Respiration limits set alarm limits. T1 limits and T2 limits set the lower and upper temperature alarm limits for each channel. Delta limits set the delta temperature alarm limits, based on the difference between T1 and T2. Capno Alarms turn capnometer alarms off or on. Resp Alarms turn respiration alarms off or on. Temp Alarms turn temperature alarms off or on. Note: If there is only one contact temperature channel, the Temp limits control replaces T1 limits, T2 limits and Delta limits. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 138 Menu option Menu screen 7.5 Setting alarms NIBP systolic limits set alarm limits. NIBP mean limits set alarm limits. NIBP diastolic limits set alarm limits. NIBP Alarms turn NIBP alarms off or on. P1 systolic limits set alarm limits. P1 mean limits set alarm limits. P1 diastolic limits set alarm limits. P2 systolic limits set alarm limits. P2 mean limits set alarm limits. P2 diastolic limits set alarm limits. P1 Alarms turn P1 alarms off or on. P2 Alarms turn P2 alarms off or on. P3 systolic limits set alarm limits. P3 mean limits set alarm limits. P3 diastolic limits set alarm limits. P4 systolic limits set alarm limits. P4 mean limits set alarm limits. P4 diastolic limits set alarm limits. P3 Alarms turn P3 alarms off or on. P4 Alarms turn P4 alarms off or on. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 139 Chapter 7 Alarms Simply press on the alarm that you wish to set and an editor will appear. This will allow you to edit both upper and lower limits of the alarm. The editor shows the range of the alarm settings. You change the alarm settings by simply typing in the desired value using the keypad or the up and down arrows. You can save the changes you have made or cancel them by pressing the relevant buttons at the bottom right. The alarm being edited is shown in the title Change the upper or lower limits by typing the desired value into the keypad or use the arrows Press here to cancel changes and go back or save changes and go back Editing Heart Rate Alarm Limits Note The alarm limit shown is the number that the Tempus will display before the alarm is activated i.e. in the example shown above the tempus will display when the heart rate is less than 50 (49 or less) or greater than 120 (121 or more). The Tempus will not alarm at 50-120 inclusive. Therefore, it is possible to have the lower and upper limits set to the same value. If any alarms are turned off, this will be shown on screen by the relevant parameter highlighted in blue. The ECG Alarm bar shows the symbol for alarms inactive and is highlighted in blue Alarms Suspended Tempus Pro User/Operator Manual - 41-2001EN-00 Page 140 7.6 Silencing or suspending alarms It should be noted that other system configuration changes e.g. ECG lead selection, QRS beat volume, gain or waveform speed changes, communications mode and communications settings, iAssist mode etc. are all settings which are stored by the Tempus. Therefore, any changes to the Tempus configuration other than alarm settings will remain set even after the Tempus has been switched off and on again (for periods less than 72 hours). 7.6 Silencing or suspending alarms The audible alarm can be silenced by pressing the Alarm Silence button on the front panel. For most patient alarms, the Alarm Silence button mutes the audible alarm for 2 minutes (factory default), after which the alarm will sound again if the alarm state is still present. During this time the visual indications of the alarm will remain (the alarm LED will remain lit and the on-screen indications will remain). The maximum (and default) alarm silence time is configurable via the maintenance menu. For instructions, see the Tempus Pro Maintenance Manual. The factory default is 2 minutes with an available range from 1 to 5 minutes. The alarm silence time may be adjusted by the user from the All Alarms menu. The adjustment is limited in the range 30 seconds up to the value of alarm silence time set via the maintenance menu. The alarm silence time will reset to the preset maintenance value when a new patient is admitted, or when switching patients. During the alarm silence period, if a new alarm occurs (patient or technical) the alarm will sound as normal. Note Note Note For certain patient alarms, pressing the Alarm Silence button ceases the alarm permanently until the condition is experienced again. This applies to the following alarms:

Capnometer No Breaths Detected;

NIBP patient alarms;

Catheter Disconnected. For technical alarms, the Alarm Silence button acknowledges and silences all active technical alarms and causes them to be displayed with this symbol:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 141 Chapter 7 Alarms This button prevents visual and audible alarms from occurring for a temporary period This button silences the alarm once it is in progress Alarm Suspend and Silence Buttons Alarms can also be silenced before they occur using the Alarm Suspend button to prevent alarms from occurring for two minutes due to intentional intervention with the patient e.g. removing or moving a patient sensor such as an ECG electrode or pulse oximeter probe.

. This enables users The Alarm Suspend button is positioned above the Alarm Silence button and has a different function. Pressing it will disable all audible and visual alarm indications for both technical and patient alarms for two minutes. During this time the yellow LED above the button will remain lit and the alarm bars on the display will indicate that alarms are paused and show a countdown for when they will be resumed. Note If a new technical alarm condition occurs during an alarms suspended period, once that period has expired there may be a delay of up to 15 seconds before the technical alarm audio is sounded. The Alarm Suspend state can be deactivated at any time during the countdown by pressing the button again. The alarm bar shows that alarms have been suspended Alarm Bar Showing Alarms are Suspended Tempus Pro User/Operator Manual - 41-2001EN-00 Page 142 7.7 Viewing and clearing alarms When a patient alarm is silenced the visual indication will remain on screen until the condition has passed i.e. the patients vital signs have returned to a level within the alarm thresholds. The non-invasive blood pressure is a periodic measurement. For this reason, an NIBP alarm is cleared by pressing the Alarm Silence or Alarm Suspend button. The alarm may then return when the next periodic reading is taken. 7.7 Viewing and clearing alarms A list of active patient and technical alarms can be viewed on a screen, from which technical alarms can be selected to display more information and to clear them. Note Patient alarms cannot be cleared in this way. To display the Alarm Status screen, press the touch screen in the alarm status area. The example screen shown below shows two patients and five technical alarms including three already silenced and acknowledged see 7.6 Silencing or suspending alarms. These are patient alarms Press on any technical alarm to display its description Alarms are shown on the Alarm Status screen in the following priority order:

Alarm Status Screen with multiple active alarms Patient alarms are shown before technical alarms. Technical alarms are shown on a first in-first out basis. Note The following technical alarm conditions take priority over patient alarms: Battery Empty

(lasts for 10 seconds or so before automatic shutdown occurs) and Ambient Temperature High or Low. Press any technical alarm in the Status Screen to display a dialog which describes the nature of the condition alarm state (as shown below). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 143 Chapter 7 Alarms A title and detailed description will be shown in the centre of the dialog box. Press here to acknowledge the message and clear the alarm state Clearing a technical alarm To clear technical alarms, use one of the following methods:

Either: press the Clear this message button on the Alarm Description Dialog screen;

Or: correct the error that caused the alarm to be raised, for example refit a patient sensor that has been disconnected. 7.8 Tactical mode warning If the Tempus is set to Tactical (Silent) Mode, then all audible alarms will be ceased (visual alarm indications will remain) see 4.3.2 Tactical mode (optional). Setting Tactical Mode to ON will give the following warning:

Once Tactical Mode is set, this will be permanently displayed in the alarm status bar. Tactical Mode Warning Tempus Pro User/Operator Manual - 41-2001EN-00 Page 144 Once set, Tactical Mode can be turned off by switching the physical switch back to its original position see 4.3.2 Tactical mode (optional). 7.9 Testing alarms Do not leave a unit in tactical mode without careful observation for alarm conditions on the screen. WARNING 7.9 Testing alarms RDT recommends that visual and audible alarms are tested before use. The alarm bar will light and the audible alarm will sound on switch on (unless the tactical switch is enabled). If users do not perceive this test occurring, they should provoke a test to check that the visual and audible alarms are working before they begin to use the device. A simple way to do this would be to insert a finger into the pulse oximeter probe, wait for a reading to appear and then remove the finger. This will provoke a technical alarm which will test the alarm bar (will light solid yellow) and the alarm tone. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 145 Chapter 7 Alarms Tempus Pro User/Operator Manual - 41-2001EN-00 Page 146

 

 

8 Summary Record of Care Recording patient encounter data can be done with the Summary Record of Care (SRoC) feature which is accessed by pressing the Event button. The Event button. Event general, assessment, intervention, fluid and drug names and details are organisationally configurable. The default names and details can all be changed to match the organisations needs. WARNING Event naming and detailed configuration must be reviewed and checked before the Tempus Pro is deployed in service. Read the details regarding event configuration in the Tempus Pro Configuration Utility User Guide. 8.1 Event capture The SRoC Events screen is displayed when the Event button is pressed. 8.1.1 General screen The SRoC General screen allows you to quickly record a category marker or multiple events up to a maximum of 200 events. General events are a subset of events selected in the configuration from the full set of assessments, interventions, fluids and drugs. They are typically the most commonly needed events. All general events are also accessible from one of the other event tabs. To record an event category for later editing, press one of the category markers on the left of the screen. The Tempus will record the category marker and automatically return to the monitoring screen. Use the General screen to record events:

To record an event with the current time but no other details, press and release the event button. To edit the time and details before recording the event, press and hold the event button. The Details Editor screen is displayed. Note If you subsequently change the time of a recorded event, the Tempus will clear the recorded vitals. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 147 Chapter 8 Summary Record of Care SRoC Navigation buttons Assessment, Intervention, Fluid and Drug category markers Event buttons: log an event with a single key press or capture event details by pressing and holding Notes editor Page up and down SRoC General Screen The Tempus Pro can be configured to display group end markers in the SRoC General screen. For more information, see the Tempus Pro Configuration Utility User Guide. Note 8.1.2 Assessment, intervention, fluid and drug screens The Assessment, Intervention, Fluid and Drug screens behave in a similar way to the General screen, allowing you to record multiple events of the corresponding type. Category markers are not available in these screens. Shows details of the event recorded Optionally SRoC can be configured to display group end markers SRoC Intervention Screen Tempus Pro User/Operator Manual - 41-2001EN-00 Page 148 Access Notes Editor Event buttons: log an event with a single key press or capture event details by pressing and holding 8.1 Event capture Assessment events Use the General or Assessment screens to record assessment events:

To record an assessment event with the current time but no other details, press and release the event button. To edit the time and details before recording the assessment event, press and hold the event button. The Assessment Details Editor screen is displayed, allowing you to edit the date and time, add an event note, or delete the event. Event details are shown here Edit date and time, note that times in the future cannot be entered Delete the event Assessment Details Editor Screen Add event notes, icon is displayed in green when populated Intervention events Use the General or Intervention screens to record intervention events:

To record an intervention event with the current time but no other details, press and release the event button. To edit the time and details before recording the intervention event, press and hold the event button. The Intervention Details Editor screen is displayed, allowing you to edit the date and time, add an event note, or delete the event. This screen contains the same controls as the Assessment Details Editor

(above). Fluid events Use the General or Fluid screens to record fluid events:

To record a fluid event with the current time but no other details, press and release the event button. To edit the time and details before recording the fluid event, press and hold the event button. The Fluid Details Editor screen is displayed, allowing you to edit the date and time, edit the volume, add an event note, or delete the event. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 149 Chapter 8 Summary Record of Care Event details are shown here Edit date and time Delete the event Enter the volume administered Add event notes, icon is displayed in green when populated Fluid Details Editor Screen Drug events Use the General or Drug screens to record drug events:

To record a drug event with the current time but no other details, press and release the event button. To edit the time and details before recording the drug event, press and hold the event button. The Drug Details Editor screen is displayed, allowing you to edit the date and time, edit the route, edit the dose, add an event note, or delete the event. Event details are shown here Edit date and time Delete the event Drug Details Editor Screen Tempus Pro User/Operator Manual - 41-2001EN-00 Page 150 Select applicable route and dose; if required use the Other options Add event notes, icon is displayed in green when populated 8.1 Event capture Enter dose value If required change the dose unit Drug Dose Editor Screen 8.1.3 Map/score screen The Map/Score screen provides access to the following editors:

Glasgow Coma Scale (GCS) Injury Map Burns Map Dressing Map TQ Map Press to access the required assessment SRoC Map/Score Screen Tempus Pro User/Operator Manual - 41-2001EN-00 Page 151 Chapter 8 Summary Record of Care GCS screen The Glasgow Coma Assessment (GCS) screen allows you to enter scores for Best Eye, Best Verbal and Best Motor. GCS is calculated by summation of the three scores. A T verbal score indicates that the patient is intubated and provides a verbal score of 1. CAUTION The GCS score is shown here Select best eye, verbal and motor scores If you exit the GCS screen without entering all three scores, then no GCS data is recorded. Access Event Details Editor Enable and disable help text To display help text, press the Help button. When you select a score with the Help button enabled, the Tempus will automatically move to the next entry screen. GCS Assessment Screen Injuries, burns and dressings maps The Injury, Burns and Dressing Map screens allow you to record the corresponding encounter details on a body map which contains a graphical representation of the front and rear of the body. The Burns Map also allows you to record the total burns area as part of the burns assessment. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 152 The numbers shown on the body indicate approximate percentage of the total body map area Add Injury Assessment notes, a green icon indicates a populated note Injury Map Screen TQ map The TQ Map screen allows you to record limb tourniquet positions and start times. First select tourniquet positions on the body map TQ Map Screen 8.1 Event capture First select injury type and then select the body map areas If necessary, use the Other buttons to define new injury type Then press the clock symbols to update the start times 8.1.4 Automatic event capture SRoC is automatically augmented with patient encounter data when:

An arrhythmia alarm is triggered - Tempus Pro automatically logs an event and records a waveform snapshot from 10 seconds before until 10 seconds after the event. A patient alarm is triggered - Tempus Pro automatically logs an event. You can also store a snapshot of the waveform at the same time, see the All Alarms menu. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 153 Chapter 8 Summary Record of Care A waveform is manually captured. To manually capture a snapshot of a waveform at any time, press and release the Camera & Waveform Snapshot button. A 12 Lead ECG is recorded. A camera or laryngoscope image is recorded. For laryngoscope details refer to Tempus Pro Laryngoscope Supplement Guide. An ultrasound image is recorded. Images can be taken during general and FAST exams. Refer to Tempus Pro Ultrasound Supplement Guide. If the Tempus is fitted with an internal printer and automatic printing is enabled, it will print waveforms as soon as they are captured see 9.9.2 Internal printer configuration (optional). 8.2 Events summary list The SRoC Summary screen displays a list of all the events entered by the user together with any events automatically captured. Each event is shown with the associated event icon as detailed in the table below. Event Type All Filter button Show All Icon All Arrhythmia Waveform Arrhyth or Waveform 12 Lead ECG Camera Image Drug Fluid Note Intervention Laryngoscope Image Assessment Waveform (Manual) Medics Alarm Waveform ECGs Images Drugs Fluids Notes Interven Images Assess Waveform Medics Waveform Injury / Burns Dressing / TQ Maps GCS Ultrasound Image Category marker: assessment, intervention, fluid or drug Scores Ultra Markers Filters allow you to select which events are shown. Pressing an event will launch the associated editor /

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 154 Icon matches marker type 8.2 Events summary list viewer, automatically recorded events can only be viewed. Category event markers can be updated by pressing on the associated row. Pressing and holding an event that is less than 72 hours old will act to launch the trend graph centred at the event time, the graph will be set to show events and set to 45 minutes zoom. 8.2.1 Summary screen Press an event to access the associated editor or viewer Press and hold an event to display the trend graph centred at the event time Show All clears all selections and displays all events SRoC Summary Screen 8.2.2 Waveform viewer To view a waveform, press the waveform event in the SRoC Summary screen:

Arrhythmia details are shown here Waveform Snapshot Viewer This is a category marker;

press this entry to enter the event details Press one or more of these buttons to filter by event type filters Displays the waveform type and date Scroll to move between waveforms Press to print waveform Scroll to move between pages of waveform snapshot If the Tempus is fitted with an internal printer, you can print the waveform using the Print button see 9.9.2 Internal printer configuration (optional). If the Tempus Pro is fitted with an internal printer and automatic printing is enabled, it will print waveforms as soon as they are captured. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 155 Chapter 8 Summary Record of Care 8.2.3 Updating an observation category marker To convert a category marker to a fully recorded event, press the category marker entry in the SRoC Summary screen. The Tempus displays the entry screen for the relevant event category. Press an event button: this acts to update the marker. Any further events buttons pressed are recorded as new events. To update marker press the required event. Press and hold required event to edit event details Press to delete the marker Updating Observation Category Marker 8.3 Trends Tempus automatically samples all continuous medical readings once per minute and stores these in the patient record. For readings taken less often such as Non-Invasive Blood Pressure all readings are stored in the patient record. The last 72 hours of trend data can be displayed on the Tempus as both graphical and tabular trend data. To access trend data, use one of the following methods:

Press the Event membrane button then select the Graph or Table tab. Press the Trends button (displayed in all medical related menus as well as the main menu) then select the Graph or Table tab. Press and hold anywhere on the Home Screen. Depending on which waveform you press the graph will show you the results of that waveform. Press and hold on any event in the Summary tab. The graph will be centred at the time of the event you press. 8.3.1 Trend graph The Trend Graph allows you to select two vitals to be shown together, each vital having its own scale. The zoom button can be used to select a different time scale for the X axis. When enabled, icons for the following events are shown on the graph at the event time. Arrhythmia 12-Lead ECG Drugs Fluids Assessments Tempus Pro User/Operator Manual - 41-2001EN-00 Page 156 8.3 Trends Interventions GCS events, but not body maps Laryngoscope image A maximum of 4 events can be displayed on the graph in a 4-minute interval and there can be a delay of up to 1 minute before events are displayed. Left / right scroll buttons move backwards /

forwards in time. Press up down arrows to adjust position of the vitals Select the vitals to be displayed Event icons are displayed in this area Press an event icon to cause the event details to be displayed here Press here to centre or zoom the graph Trend Graph 8.3.2 Trend table The Trend Table allows you to scroll through all the 1-minute sample readings. When enabled the following events are also displayed:

Waveform Arrhythmia Patient Alarm Camera Images Laryngoscope Images 12-Lead ECG Drugs Fluids Assessments Interventions Body Maps and GCS Ultrasound Images Tempus Pro User/Operator Manual - 41-2001EN-00 Page 157 Chapter 8 Summary Record of Care Data is shown from the last entry (last minute) and then the preceding entries. Press here to filter the data by time Trend Table Use these arrows to scroll through the readings Press here to turn the display of events on and off An outside limits symbol placed to the right of reading indicates that the value was outside the limits set when the measurement was taken. In the case of a reading containing multiple values such as non-invasive blood pressure the alarm symbol will not show which value was outside the limits. Outside limits symbol indicates that the adjacent measurement was outside the limits Outside Limits The outside limits symbol will only be shown for patient alarms. It will not be shown to reflect any technical alarms such as low battery, finger out of SpO2 sensor etc. It will not be shown for invasive pressure transducer removed but will be shown for Capnometer zero breaths detected. The symbol shows only that the value at the time was outside the alarm limit that was set at the time it will not change based on subsequent editing of the alarm threshold. It will not be shown for out of range measurements. It will not reflect if an audible alarm was present i.e. will not differentiate if an alarm is muted, alarms suspended etc. it will merely reflect that the measured parameter was outside of the alarm threshold set at the time. Note The trend table shows a single reading where multiple readings may have occurred e.g. 60 individual readings for heart rate that are taken in a minute are represented as a single reading; this is the first reading recorded in that period. If a single alarm on a given parameter occurs within the time period set, then this will be shown in preference to the first reading taken within the period. If multiple alarms occur in the same period on the same parameter, then the trend table will show the first to occur. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 158 9 Other features of the Tempus Pro This section details the other features of the Tempus Pro. 9.1 Data input and output 9.1.1 The Data Input and Output menu The Data Input/Output button. Pressing the Data Input/Output button launches a menu which allows you to do the following:

Menu option Menu screen Send patient data/report send patient data or reports to external recipients, see 9.1.2 Send patient data/report. Tempus to Tempus data handover export and import patient data for handover to or from another Tempus, see 9.1.3 Tempus to Tempus data handover. Laryngoscope access laryngoscope functionality. For further details refer to Tempus Pro Laryngoscope Supplement Guide. Ultrasound access ultrasound functionality, for further details refer to Tempus Pro Ultrasound Supplement Guide. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 159 Chapter 9 Other features of the Tempus Pro 9.1.2 Send patient data/report The Send patient data/report option allows you to output the SRoC patient data or report to one of four types of recipient:

USB memory device patient report (PDF);

External printer patient report;

Email address (if the feature is installed) patient report (PDF);

ePCR (electronic Patient Care Reporting system) (if the feature is installed) patient data;

Internal printer (if fitted) - summary report or 30 second waveform. When sending the patient report to email, USB or external printer, you can select one of the following report formats:

12-lead Report Summary Report Detailed report When sending to ePCR, all patient data is sent. The contents of the report or data depend on the report destination, as shown in the following table:

Data USB, External Printer and Email

(detailed report) ePCR

(patient data) Internal Printer

(summary report) SRoC events All Trended vitals Up to 72 hours All All Last 100 events Last 200 minutes limited to HR, NIBP, Resp, ETCO2, SpO2, T1 and T2 12-lead ECG recordings Camera /

intubation images Image annotations Latest (up to 10) Latest (up to 10) Latest (up to 10) Latest (up to 20) Latest (up to 10) None Waveforms Latest (up to 20) Latest (up to 20) Ultrasound images Latest (up to 5) and FAST exam Latest (up to 5) None None None None None Detailed reports are automatically formatted such that graphs and tables are not too long. Consequently, if the recorded incident is up to 40 minutes long, all vital signs graph and table data are shown sampled at one minute intervals. Longer incidents are reformatted as follows:

Duration 40-200 minutes: sampled at 5 minute intervals. Duration over 200 minutes: sampled at 5 minute intervals (latest 200 minutes only). CAUTION The reports created are medical records, the use and control of which may be subject to local regulations, e.g. HIPAA in the USA. It is the responsibility of the user to maintain compliance with these regulations. It is the responsibility of the individual or organisation who created the record to maintain this information in a secure and confidential state where the integrity and security of the information is not in question. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 160 CAUTION Patient reports (PDFs) must be encrypted and password protected. The password must be preconfigured (Maintenance and Settings, Change Passwords, Patient Report Password) by following the procedure in the Tempus Pro Maintenance Manual. Configuration must be checked before deployment in service. The encryption type is AES128. 9.1 Data input and output Note Note RDT recommends only Adobe Acrobat PDF readers that are capable of reading Acrobat V5 or later files are used. RDT recommends users check that their selected PDF reader can open the created report before deploying the Tempus. Send patient report to a USB memory device To send the SRoC patient report (PDF) to a USB memory device, press Send patient data/report on the Data Input/Output menu, then press USB on the Send Patient Data/Report screen:

Select the patient report format Select the contents of the report

(if this feature is enabled). Use the arrow buttons to scroll to next and previous pages. Press Send to start writing to USB memory device Send Patient Data/Report Screen (USB selected) If handover data is required on the USB device, press Include Tempus to Tempus Data. Press Send. The Tempus will return to the main monitoring screen. Progress information will be displayed at the top of the screen. To check progress or cancel USB output, return to the Send Patient Data/Report screen. This screen will display a blue progress bar with status messages. If the Tempus has been configured to encrypt the SRoC patient report using a random password, then the password details will be displayed on the Send Patient Data/Report screen under the list of report formats. Send patient report to an external printer WARNING Printer connections should only be made when no connections are made to a patient. Do not connect to a patient and a printer at the same time as this could cause a leakage current hazard or could affect the clinical performance of the Tempus. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 161 Chapter 9 Other features of the Tempus Pro The screen Send Patient Data/Report screen also has an option to send the SRoC patient report directly to a PCL3 compliant USB printer which operates in a similar way to sending to USB memory device. Ensure the printer is attached, switched on and provided with ink and paper before beginning. For printer instructions, see 9.9.1 External printer. To send the SRoC patient report to an external printer, press Send patient data/report on the Data Input/Output menu, then press Ext. Printer on the Send Patient Data/Report screen. Send patient report via email CAUTION Email services are generally very reliable but do not guarantee successful delivery. Email send times vary depending upon network conditions. You should always check that an emailed patient report has been received, e.g. by phoning the recipient. CAUTION CAUTION Note Note The email service requires a valid email account on a server accessible from the internet. It is your responsibility to understand the local regulations regarding emailing patient data. Tempus emails must be sent using secure communications. For email transmission, the maximum allowed patient report size is 8 megabytes. Email service provider limits may differ. The links below provide information about HIPAA compliant email:

http://www.hipaahq.com/hipaa-compliant-email-explained/

http://www.hipaahq.com/hipaa-compliant-email-providers/. To send the SRoC patient report (PDF) via email, press Send patient data/report on the Data Input/Output menu, then press Email on the Send Patient Data/Report screen:

Press one of these buttons to select report format Recipient button: press here to change the email recipients and communications mode Send Patient Data/Report Screen (Email selected) Select the contents of the report

(if this feature is enabled). Use the arrow buttons to scroll to next and previous pages. Press here to send report Press the recipient button to display the Email Recipients screen. Update email recipients and communications mode as required, then press Back to return to the Send Patient Data/Report screen. Press the Send button. This will cause a PDF report of the selected format to be created and emailed. The Tempus will return to the main monitoring screen and display email status at the top of the screen. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 162 9.1 Data input and output To check progress or cancel emailing, return to the Send Patient Data/Report screen. This screen will display a blue progress bar with status messages. The top status area will display the PDF creation and network status details. When the email has been sent to the email server, the report sent text will be displayed on the top status area for a further 30 seconds. If the Tempus has been configured to use a random password, then a second email containing the random password will be sent to the recipients. In the event of communication problems, the Tempus will attempt to resend for 20 minutes before aborting the send and displaying a warning message. Send patient data to an electronic Patient Care Reporting System (ePCR) CAUTION CAUTION Note Note Note Communication with the ePCR systems are generally reliable but do not guarantee successful delivery and storage of the patient data. It is your responsibility to understand the local regulations regarding sending and storing patient data. Tempus patient data is sent using secure communications to one of the configured ePCR systems. The configuration must be checked before deployment in service. For ePCR data transmission, the maximum allowed patient data size is 8 megabytes on the Tempus Pro. The link below provides information about HIPAA compliant cloud storage providers:

http://www.hipaahq.com/hipaa-compliant-cloud-storage-explained/. To send the SRoC patient data files to an ePCR, press Send patient data/report on the Data Input/Output menu, then select the ePCR tab on the Send Patient Data/Report screen:

All patient data is sent To button: press here to change the ePCR system and communications mode Send Patient Data/Report Screen (ePCR selected) The contents of the patient data to be exported are shown here. Details of the last ePCR export will be displayed below the patient details Press here to send the patient data to the ePCR Press the To button to display the ePCR Selection screen. Select the ePCR system and communications mode as required, then press Back to return to the Send Patient Data/Report screen. Press the Send button. This will cause patient data to be sent to the selected ePCR system. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 163 Chapter 9 Other features of the Tempus Pro To cancel sending ePCR data press the Cancel button. In the event of communication problems, the Tempus will attempt to resend for 20 minutes before aborting the data export and displaying a warning message. Send patient report to the internal printer (optional) To send the summary report or 30 second waveform to the internal printer (if fitted), press Send patient data/report on the Data Input/Output menu, then press Print on the Send Patient Data/Report screen:

Press one of these buttons to select report type Send Patient Data/Report Screen (Print selected) Press a report type button: Summary Report or 30s Waveform. Press Print. Press here to print report Tempus Pro User/Operator Manual - 41-2001EN-00 Page 164 9.1 Data input and output 9.1.3 Tempus to Tempus data handover The Tempus to Tempus data handover screen allows you to send or receive patient data using a USB memory device or Tempus to Tempus USB data cable (part number 01-2243). The output is a complete patient data package for handover from one Tempus to another. This allows Tempus data to move with the patient and for the next level care giver to see the history of injuries and treatment in the field. CAUTION Do not import patient records back onto the originating Tempus (directly or once-removed). Exporting / importing is for handing over data from one Tempus to another only. Prerequisites ensure that you have the following:

Tempus Pro to send patient data;

Tempus Pro to receive patient data;

USB memory device or Tempus to Tempus USB data cable (part number 01-2243). Handover via USB memory device To export patient data:

1. Insert a USB memory device into the sending Tempus Pro. The Tempus automatically opens the Data Input/Output Menu screen. 2. Press Tempus to Tempus data handover. The Tempus opens the Tempus to Tempus data handover screen:

Press here to start the export process Press here to start the import process Tempus to Tempus data handover USB memory device 3. If the PDF patient report is required by the recipient, set Include pdf in export to yes. 4. Press Export for Handover. If the USB device contains any existing Tempus patient data records, you will be asked if you want to keep or overwrite them. 5. The Tempus to Tempus data handover screen displays a blue progress bar with status messages. When the export progress bar displays Finished, remove the USB memory device and hand it to the next level care giver. To import patient data:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 165 Chapter 9 Other features of the Tempus Pro WARNING When importing, ensure that you select the correct patient record. Records can be identified by patient name (last and first), ID number, or incident start time. If you are not sure if the record you wish to select is the correct one, then select Admit as new patient. Mixing different patient records could lead to confusion and misdiagnosis. 1. Insert the USB memory device into the receiving Tempus Pro. The Tempus automatically opens the Data Input/Output Menu screen. 2. Press Tempus to Tempus data handover. The Tempus opens the Tempus to Tempus data handover screen. 3. Press Import for Handover. The Tempus displays a list of all patient incidents found on the USB memory device. Select the patient incident record to be imported. 4. The Tempus displays the Import Patient Record screen. Press one of the following options:

Merge this merges the imported incident data into the current patients data record. Admit as new patient this discharges the current patient and imports the incident data as a new patient. 5. Press Confirm. The Tempus to Tempus data handover screen displays a blue progress bar with status messages. When the import progress bar displays Finished, remove the USB memory device. Handover via USB data cable Note When the Tempus detects the USB data cable, it disables the Include pdf in export option. To transfer the patient incident data from one Tempus to another:

1. Insert the Tempus to Tempus USB data cable (part number 01-2243) into the sending and receiving Tempus Pros. 2. Both Tempus devices automatically open the Tempus to Tempus data handover screen. Either press Export for Handover on the sending Tempus, or press Import for Handover on the receiving Tempus. 3. The Tempus to Tempus data handover screen displays a blue progress bar as it zips and sends the data. 4. The receiving Tempus displays the Import Patient Record screen. Press one of the following options:

Merge this merges the imported incident data into the current patients data record. Admit as new patient this discharges the current patient and imports the incident data as a new patient. 5. Press Confirm. 6. The Tempus to Tempus data handover screen displays a blue progress bar with status messages. When the import progress bar displays Finished, remove the USB data cable. 9.2 Display options 9.2.1 The Display menu The Display button. Pressing the Display button launches a menu which offers options on the display configuration. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 166 Menu option Menu screen 9.2 Display options Select the home screen display view (from left to right):

Four channel view (the default). Two channel view (large ECG). Large numeric view. Twelve lead diagnostic view. This is only active when the 12 lead ECG cable is attached to the device. See 9.2.2 Display modes. High Contrast turn high contrast display on or off, see 9.2.3 High contrast mode. Waveform / Lead Selection open the Waveform Selection Menu, see 9.2.4 Waveform and lead selection. Brightness select the screen brightness level, see 9.2.5 Brightness control. Lock touchscreen lock the touchscreen, see 9.2.6 Locking the touchscreen. Power save mode turn power saving on or off, see 9.2.7 Power save feature. This setting does not persist after powering off the device. Corsium Crew - for use with the Corsium Crew extended display (optional). See the Corsium Crew User Guide. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 167 Chapter 9 Other features of the Tempus Pro 9.2.2 Display modes The Display Menu offers different ways to display the vital signs data on the Home screen. Each Home screen display option is shown as an icon. Pressing the icons changes the Home screen display mode. In addition to the 4 channel display (described previously), the Tempus also offers the following Home screen display options. Large Amplitude ECG Waveform Display Large numeric display Tempus Pro User/Operator Manual - 41-2001EN-00 Page 168 9.2 Display options 12 Lead ECG View The second waveform in the large ECG view defaults to display the impedance pneumography (ECG respiration) if the Capnometer is not plugged in. When switching between the 4 waveform and the large ECG views, the ECG gain and wave speed does not change except if the gain is set to 2 mm/mV on the 4 channel view in which case the ECG will be displayed as 4 mm/mV. The user can subsequently adjust the gain settings to optimise the available waveform height. For details on changing gain settings, see 6.1.8 ECG settings. Note Note 9.2.3 High contrast mode The first button below the different home screen views allows the user to enable a high contrast display mode on the results screen. Enabling this allows the Tempus to display vital signs data in a black on white display for high daylight conditions (shown below). The high contrast display mode can be enabled automatically by pressing and holding the button for 2 seconds. This allows the user to switch the high contrast display on by pressing a single button. Note The high contrast display is available for all Home screen display modes. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 169 Chapter 9 Other features of the Tempus Pro High Contrast Display Activated 9.2.4 Waveform and lead selection Use the Waveform / Lead Selection screen to customise the display of waveforms in the four-waveform home screen. To access this screen, either press the Display button and then press Waveform / Lead Selection, or from the ECG Settings menu press Waveform / Lead selection. Press the waveform region that you want to update

(the first is reserved for ECG) Press the ECG lead that you wish to display in the selected waveform region

(ECG cable dependent) Waveform Selection Press to display plethysmogram or capnogram in the selected waveform region Press to display AA gas vitals (optional) Press the IP sensor that you wish to display in the selected waveform region

(P1 to P4 as available) Note If Corsium Crew is enabled, the Waveform / Lead Selection screen will include 'Crew App'

waveforms. See the Corsium Crew User Guide. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 170 For example, you may want to move pressure P2 to a numeric area and display the plethysmogram waveform instead:

Before this change is made, the home screen looks like this:

9.2 Display options Pressure P2 waveform and data SpO2 data Standard home screen with 2 IP channels connected From the Display Menu, press Waveform Selection. On the Waveform Selection screen, change the Waveform 3 setting from P2 to PLETH:

Press Waveform 3 Press PLETH Setting Waveform 3 to PLETH Tempus Pro User/Operator Manual - 41-2001EN-00 Page 171 Chapter 9 Other features of the Tempus Pro After this change, the home screen looks like this:

Waveform 3 now displays the plethysmogram and SpO2 data Home Screen with Plethysmogram in Waveform 3 Note You can swap two waveforms around by selecting both waveform regions. The waveform selection feature is not available when iAssist Mode is activated This numeric area now displays pressure P2 data 9.2.5 Brightness control The Display Menu includes a screen brightness control. The screens brightness has five available settings as follows:

Min 10%;

Low 30%;

Mid (default) 60%;

High 80%;

Max 100%. Using a lower brightness setting will improve battery life. WARNING The low display settings are intended for use by military and civilian pre-hospital care users for scenarios where low emitted light is required or desired. Users are reminded that while these functions are enabled, the device will present a display that may be too dim to see in daylight conditions. Users should therefore ensure that they use this feature only when required and recognise that greater levels of patient care and supervision will be required. Note Min, Low and Mid are compatible with NVGs (night vision goggles) see 4.3.2 Tactical mode (optional). The Max setting should only be used for strong sunlight applications. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 172 9.2.6 Locking the touchscreen The Lock Touchscreen function allows the touchscreen to be intentionally disabled. If this feature is activated the Tempus will display the message shown below:

9.2 Display options Touchscreen Lock Activated This message stays on the screen for 2 seconds. After that point, if any button, control or the touchscreen are pressed the following message will be displayed. Some technical alarm conditions allow you access to the touch screen but once you return to the home screen the lock will still be active. To disable the touchscreen lock, simply press the buttons marked 1 then 2 within 3 seconds of each other. If neither button is pressed, or the buttons are not pressed in the correct sequence, then the message will leave the screen after 5 seconds. First press here Then press here within 3 seconds Touchscreen Lock Deactivate Tempus Pro User/Operator Manual - 41-2001EN-00 Page 173 Chapter 9 Other features of the Tempus Pro 9.2.7 Power save feature When power save is activated the display turns to min brightness after 3 minutes of no use (i.e. no user controls or alarms). If there is a further 2 minutes of no use the display turns off. The Tempus Pro continues monitoring etc. whilst the screen is off and the devices display will come back on at its original brightness as soon as an alarm is triggered, the touch screen is pressed or a keypad button is pressed. This control can be used to extend the battery life of the Tempus. 9.3 Patient information 9.3.1 The patient menu The Patient button Pressing the Patient button launches a menu which will offer options on the management of patient data. This menu allows you to:

Menu option Menu screen TC3 card complete an electronic version of the military Tactical Combat Casualty Care

(TCCC) card, see 9.3.2 Updating the TCCC card. Patient details enter the patients name, ID and allergies, see 9.3.5 Entering patient details. Discharge/admit patient discharge the current patient and admit a new patient, see 9.3.3 Admitting a new patient. Switch to a previous patient switch to a previously monitored patient, see 9.3.4 Switching to a previous patient. Medics - enter details of medics (first responders). End of shift allows you to clear the patient list. This means that you will not have access to previous patient incidents. Note: The TC3 card option is only available on Tempus units sold to military users. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 174 9.3 Patient information 9.3.2 Updating the TCCC card Pressing the TC3 Card button allows you to complete an electronic version of the military TCCC card. This feature is designed to replace the paper version used in the field. The screen is therefore laid out like a two-

sided card and behaves the same way: you can insert, amend and delete TCCC data until the card is exported to a USB stick. WARNING It is the users responsibility to ensure the information recorded in the TCCC is accurate and complete. Omissions or inaccuracies could lead to mis-diagnosis resulting in death or serious injury. Press these buttons to switch between Side 1 and Side 2 of the card Press this area to enter or edit the patients name and details Press the New button to bring up AVPU and Pain buttons to select from (time and vitals are recorded automatically) Press this area to record ABC and other interventions Press this button to enter medics details Press one of these buttons to record the urgency of the casualty Press these buttons to record injuries and TQ locations Press these buttons to enter fluids or drugs Press this button to enter notes TCCC Card Side 1 TCCC Card Side 2 The TCCC Injury and TQ editors provide body maps on which injuries and tourniquets may be recorded. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 175 Chapter 9 Other features of the Tempus Pro TCCC Injury Map The drugs editor can be configured to contain all the drugs provided by the military for standard medics. The dosages and routes can be edited, but by default should be those most commonly used. TCCC TQ Map Tempus Pro User/Operator Manual - 41-2001EN-00 Page 176 9.3 Patient information Press and release a drug button to record a drug you have administered with the default time, route and dose. Press and hold a drug button to edit the time, dose or route of a drug before it is recorded. To edit the time, dose or route of administration of a drug before it is recorded, press and hold the drug button. This brings up an editor which allows any time (in the last 24 hours) to be selected and for the dose and route to be edited. TCCC Drugs Editor Press this button to enter the time of administration. Press one of these buttons to enter the route of administration. Press one of these buttons to enter the dose. The fluids editor can be configured to contain all the fluids provided by the military for standard medics. The volumes can be edited, but by default should be those most commonly used. TCCC Drugs Time, Does and Route Editor Tempus Pro User/Operator Manual - 41-2001EN-00 Page 177 Chapter 9 Other features of the Tempus Pro Press and release a fluid button to record a fluid you have administered with the default time and volume. Press and hold a fluid button to edit the time or volume of a fluid before it is recorded. To edit the time or volume of a fluid before it is recorded, press and hold the fluid button. This brings up an editor which allows any time (in the last 24 hours) to be selected and the volume to be edited. TCCC Fluids Editor Press this button to enter the time of administration. Use the keypad to enter the volume. TCCC Fluids Time and Volume Editor Note Note If GPS is turned on and a fix is available, drug records will be geo-tagged with the location when the record is entered see 9.5 GPS location. REMEMBER the TCCC card is a paper replacement system. Like a piece of paper, all information in the TCCC card can be edited or deleted up until the point the data is exported onto a USB stick see 9.1.3 Tempus to Tempus data handover. Switching to a previous patient will allow the user to re-access the previous TCCC card and edit it see 9.3.4 Switching to a previous patient. If the Tempus is connected to a response centre they will not be able to see the TCCC card being edited but will be able to see a fixed update of the TCCC card on their system every 2 minutes. The response centre user is not able to edit the TCCC card, only view it see 9.6.5 Interacting with the Response Centre. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 178 9.3.3 Admitting a new patient If the Discharge/admit patient button is pressed, the Tempus will bring up a new dialog which asks you to confirm if the patient is new or not and gives the options to enter the new patients name immediately or later. A warning is displayed if the current patient is still being monitored (see below). 9.3 Patient information Press here to admit a new patient but enter their details later Press here to admit a new patient and start entering their details immediately The current patients name

(if entered) is shown here Warning if user is attempting to admit a new patient whilst already monitoring Admitting a New Patient If a connection has not been established to a Response Centre, all data for that patient can be transmitted later so long as a new patient is not admitted. For details on communications with a Response Centre, see 9.6 Connecting to an alternate location. Once a new patient is admitted, the recorded data cannot be transmitted to the Response Centre. WARNING Ensure that the Tempus Pro is disconnected from the old patient before confirming that a new patient is being monitored. Failing to do so will mean that real-time vital signs data from the old patient will be entered with the record for the new patient. CAUTION If the Tempus is connected to a Response Centre, discharging the old patient and starting to monitor a new one will create a new patient record at the Response Centre also. Ensure the Response Centre user understands who is being monitored. CAUTION Note Admitting a new patient will reset all alarm settings to the factory defaults see 7 Alarms. Do not attempt to connect the Tempus Pro to other medical systems until such functionality is properly supported in software. It should be noted that if the patient is removed from all real-time sensors then the Tempus will lose its real-

time detection of the patients presence. This scenario could be caused by users needing to move the Tempus from one patient (cease monitoring that patient) as they intend to start monitoring a new patient. In the instance that all real-time patient signals are lost for more than 5 minutes, the Tempus will anticipate that the user could be moving from one patient to a different one. It will therefore automatically give the user the option of switching to a new patient without having to press the Patient button (as described earlier in this section). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 179 Chapter 9 Other features of the Tempus Pro Pressing here to confirm that the Tempus has been put onto a new patient Press here to switch to a previously monitored patient Press here to confirm that the same patient as before is being monitored Patient Reset Options WARNING Ensure that you select the correct patient record. Records can be identified by patient name (last and first), ID number, or incident start time. If you are not sure if the record you wish to select is the correct one, then select new patient. Mixing different patients records could lead to confusion and misdiagnosis. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 180 9.3 Patient information 9.3.4 Switching to a previous patient The Tempus allows you to switch between the current patient and a patient that has been monitored on the same Tempus device within the previous 72 hours. The Tempus will also show patients admitted more than 72 hours ago, but only up to a total of 20. This feature may be used, for example, in multi-casualty situations. To switch between patients, simply press the Switch to a previous patient button and then select from any patient that is shown in the list. If no patients are shown, then there are no records to select from. Press on the patient that you wish to switch to Press here to confirm once you have selected the correct patient Selecting From Previous Patients WARNING Ensure that you select the correct patient record. Records can be identified by patient name (last and first), ID number, or incident start time. If you are not sure if the record you wish to select is the correct one, then select new patient. Mixing different patients records could lead to confusion and misdiagnosis. WARNING Ensure that the Tempus Pro is disconnected from the old patient before confirming that a new patient is being monitored. Failing to do so will mean that real-time vital signs data from the old patient will be entered with the record for the new patient. CAUTION If the Tempus is connected to a Response Centre, discharging the old patient and starting to monitor a new one will create a new patient record at the Response Centre also. Ensure the Response Centre user understands who is being monitored. CAUTION Admitting a new patient will reset all alarm settings to the factory defaults see 7 Alarms. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 181 Chapter 9 Other features of the Tempus Pro 9.3.5 Entering patient details Pressing the Patient Details button allows the patients name, ID and allergies to be entered. Press the buttons to select what details you wish to enter Predicted text options will appear here based on what is typed, press any option to select it Press here to accept the details you have entered. You can go back and edit or delete any data later Entering Patient Details The patients age (or age group) and sex can be entered at any time. If the age (in years) is entered by the user, the Tempus calculates the age group. If the patients age is not known or is less than 1 year, the user can select the patients age group. The Tempus uses the selected age group to update alarm limits. WARNING Patient age group is an important factor for determining the correct initial inflation pressure (and maximum inflation pressure) for non-invasive blood pressure measurements in children of 12 years and under and also for neonates (28 days old or less) see 6.2.3 NIBP settings. Failure to set the correct age group for these patients may result in them being subject to higher inflation pressures than is warranted. For new patients, the default settings are Adult/Male. Always check and enter the patients age or select the correct age group. CAUTION Note Patient age affects the settings used in some medical modules. Weight and height are included in the patient report but do not affect any monitoring settings in the Tempus Pro medical parameters. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 182 9.4 Digital camera If patients age is known, use this keypad to enter age in years

(zero is interpreted as Paediatric) Press here to record the patients sex Entering Patient Age & Sex If patients age is not known or is less than 1 year, press here to select the patients age group:

Adult: > 12 years Paediatric: 29 days to 12 years Neonate: < 29 days The entered age or selected age group is shown here 9.4 Digital camera the Camera & Waveform Snapshot button. Holding the Camera & Waveform Snapshot button for more than 2 seconds launches a camera screen. The camera screen can also be launched from the main menu camera button. This shows the viewfinder of the camera and provides buttons to take a still picture, turn on the backlight or transmit video. It is possible to capture and send still digital pictures using the camera built into the device. If the Tempus is connected to a Response Centre, then the image is sent immediately automatically. If it is not connected, the image is stored and can be uploaded later if a connection to the Response Centre is made. Digital pictures are shown live on the Tempus Pro screen so that you can see what the camera is seeing. When you are happy with the displayed image, you capture the picture and can then send it to the Response Centre. After pressing the Take a photo button the Tempus will display a 3 second countdown during which time the photo can be cancelled without being saved or transmitted. A backlight is provided to help light the subject. Real-time video can be transmitted if a data connection with sufficient bandwidth is connected to the Response Centre. Note Note Do not look directly at the backlight or shine in eyes unnecessarily. The camera is intended to allow photos of the patient to be taken (as part of the care record) or to be transmitted to enable the user at the Response Centre to see the patient (e.g. helping to decide the best care path and options will be aided by being able to see the patient). The Tempus Pro is NOT a teledermatology system or similar device. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 183 Chapter 9 Other features of the Tempus Pro If video is being transmitted this icon will be shown The real time vital signs readings are displayed here Data must be connected to transmit video Press these buttons to take a still photo, toggle the backlight on and off, and transmit video Camera & Video Options Menu Moving video is intended to give the Response Centre the ability to see the patient moving or to see around the patients environment. Users should remember that the resolution and quality of the received video stream will not be the same as they see on the screen of the Tempus Pro due to the effects of the video being compressed during transmission. This effect is lessened when the image being filmed is more stable or has less activity in it. Therefore, in order to ensure the received video is good quality, Users should try to move the camera slowly. If rapid movement of the camera is necessary then the received image is likely to have a temporarily lower level of resolution (will appear blocky) while the camera is being moved around, this effect will reduce once the camera movement is reduced. The overall image quality and resolution of the camera is greater for still pictures than moving video. If the Response Centre require an image with a reasonable level of detail

(such as a close-up image) then a still photo would probably be more suitable. Unlike still photos, moving video images are not stored on either the Tempus or at the Response Centre. They are real-time images only. Note Note Note 9.4.1 Annotation of digital pictures Images transmitted from the Tempus Pro can be altered using the software at the Response Centre. The altered image can then be sent back to the Tempus Pro to act as a support in the remote diagnostic procedure i.e. the physician can send pictures back that can be used to confirm exactly the issue being examined or discussed, thus avoiding the danger of misunderstanding verbal descriptions. Images can be amended using the following tools:

Addition of text Addition of circles Addition of lines and arrows Addition of free-form lines Selection of colours for added graphics Tempus Pro User/Operator Manual - 41-2001EN-00 Page 184 9.5 GPS location 9.5 GPS location The Tempus Pro has a built-in GPS receiver. You can access this feature from the Main Menu see 5.2.1 The main menu. The GPS may take up to 4 minutes to display a fix. If it is unable to obtain a fix (if the view of the sky is obstructed or if the unit is used indoors) then it will display an error. The most recent fix (with the time and date of the fix) is always displayed. If the signal from only a limited number of GPS positioning satellites can be received by the Tempus (e.g. because of partial blocking of the sky by objects, buildings etc.) then the fix may be less accurate. In this case the fix will be labelled Approximate fix and the reading may be +/-2.5 km. When the receiver is searching for a fix, it will report Locating When the position has been found it will be reported here Pressing here the Back button to return to the Home Screen The GPS receiver can be toggled on and off here GPS Menu Note Note The GPS operation will be limited if the Tempus Pro is not used outside with a clear view of the sky. The GPS is intended to provide the User and the Response Centre with the patients location. It should not be used as a guidance or navigation device. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 185 Chapter 9 Other features of the Tempus Pro 9.6 Connecting to an alternate location This section describes how to connect the Tempus Pro to an alternate location to share data, typically a telemedicine support centre or response centre. i2i ReachBak (optional) In addition to being used as a vital signs monitor, the Tempus Pro can also be used to transmit the patients vital signs, photos, moving video or position to an i2i Response Centre (if the i2i ReachBak feature is enabled). The user of the Tempus can also speak to the Response Centre with the Tempus. To do this you will need to:

Ensure the device is set to use an appropriate Communications Mode. The Tempus can connect to the same Response Centre through a number of different, pre-set configuration Modes e.g. using Ethernet, WiFi or GSM (cellular data) over a specific communications device. Normally the Tempus should be pre-configured to the correct mode but it may be necessary to change this from time to time see 9.6.4 Communications modes. Make the data connection from the Tempus Pro to the Response Centre. Fit the Headset comfortably in your ear. The Tempus Pro can be left running with the data link connected but with the voice link disconnected i.e. if the Response Centre physician wishes to continue monitoring the patient for a long duration but without keeping the voice link open with Tempus Pro User. In this case the voice link can be reconnected at any time by pressing the Connect button. Note Note Note Users are reminded that a valid cell phone network SIM card is required to be fitted to the Tempus in order to support cell phone connections. The characteristics of the communications network in use must be sufficient to enable the Tempus to communicate. Details of the Tempus communications specifications are provided in 14.4 Communications. Ensure that the network is sufficient to enable the devices communications to operate as described in this manual. Should the communications network not be sufficient to enable reliable communications, the Tempus will attempt to re-establish communications for a limited number of attempts and will then show an error message. This situation is not hazardous but will prevent communications from occurring. In this situation the connection to the network should be checked, the network operation should be verified and if necessary/possible the network re-

started before attempting communications with the Tempus again. If the network fails during transmission the user can expect to see intermittent data transfer (complete failure or intermittent performance of data, voice or video). Again this is not hazardous in nature but users should wait to see if the network performance improves and then consider taking the steps detailed above to fix the problem. CAUTION In accordance with IEC60601-1 clause 14.13, responsible organisations should be conscious of the potential risks to patients e.g. risk of electric shock through the use of un-

isolated electrical devices, the potential increase in summed leakage currents through the connection of devices etc. that could occur from connecting medical devices to communications networks. In addition, the impact of the use of the Tempus should be considered (e.g. bandwidth allocation). When making changes to the network (including adding or removing, updating or upgrading components), those responsible should take into account the bandwidth and other technical requirements (such as addressing and maintaining the appropriate ports in an open state) of the Tempus and ensure that these requirements are maintained. For details see 14.4 Communications. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 186 9.6 Connecting to an alternate location 9.6.1 Making the data connection Note The iAssist help processes on your Tempus Pro may differ from this example iAssist help process in the following sections. However, the process always follows the same key elements. Always ensure that you read the complete iAssist help process in order and do exactly what it requires Press the button on the touch screen to get instructions on how to setup and make the data connection. Note that these instructions will appear by default every time you turn the unit on. The title of the connection process is shown here, this is user configurable Press here to return to the modes menu Follow the graphical and text instructions to set the unit up. Note that the set up instructions of any communication devices you are connecting to must be followed also. Example Data Connection Process Once the data connection process has been completed, press the Dial Data button to start the data connection process. Note These instructions are provided in iAssist format see 9.7 iAssist processes. In the event that an alarm occurs, the Tempus will immediately revert back to the Home screen so that the alarm condition can be seen. Note The instructions shown above are examples, the on-screen instructions may differ depending on what Connection Mode the Tempus Pro is in. Users are reminded to read and follow the instructions on screen paying attention to both the written instructions and the graphics which show how to perform different elements of the task. If the Response Centre cannot be contacted, this could be due to errors in the way that the connection has been attempted. Help will be given in the form of an iAssist help process, follow the instructions given and wait for a few minutes before trying again. For Troubleshooting information, see 11.5 Troubleshooting. If the Tempus cannot connect to the Response Centre first time, it will automatically make a number of redial attempts (typically 3). The system will indicate the redial process by displaying a number over the Data Link status indicator. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 187 Chapter 9 Other features of the Tempus Pro 9.6.2 Fitting the headset and making the voice connection After starting the data connection, the Tempus will bring up instructions to make the voice connection. If a voice connection is not required press the Home button. The voice connection can be made using either the pre-attached Bluetooth headset or the wired headset (accessory). It is important to have attached the headset before dialling as the voice connection to the Response Centre can be made quickly. Remember that often the voice connection will be made over a satellite link so you may experience background noise or drop-outs. RDT recommends that you adopt a process of only one person speaking on the line at a time and then handing over to the other speaker by saying over or similar. The voice connection can be setup only if the data connection is established first. The voice connection can be disconnected (hung up) while the data connection remains established but a voice connection cannot be made without a data connection. The voice connection is essentially a VoIP call. This is routed directly to a laptop/PC. Additional third-party hardware can be purchased to route the VoIP call to a landline if this is required RDT should be contacted for technical support. The voice connection is typically the means for the Tempus user to alert the personnel receiving the data that there is data to be received. Other means (such as a radio) can be used to notify personnel of an incoming data connection. Follow the graphical and text instructions to set the unit up. Press here to start the voice connection Voice Connection Process Using a Wired Headset Adaptor Cable Press here to get instructions on using the wireless headset Tempus Pro User/Operator Manual - 41-2001EN-00 Page 188 9.6 Connecting to an alternate location Follow the graphical and text instructions to set the unit up. Press here to get instructions on using a wired headset Voice Connection Process Using the Wireless Headset The progress of the data connection being established is shown here in place of the patients name/age Press here to get further instructions on setting up the voice connection To use the Bluetooth headset, follow the on-screen instructions. When the headset is turned on, the Tempus will attempt to find it. During this time (20 seconds) a countdown will be displayed. Once the Tempus has located the headset it will confirm this on screen before resuming with the voice connection instructions. Once the voice connection process has been completed, press the Dial Voice button to start the voice connection process. Note When using VoIP, the voice connection may take 10-15 seconds to setup after the Dial Voice button has been pressed. Using the wireless headset The Tempus Pro uses the Presence or VMX200 Bluetooth headset provided by Sennheiser. Note that the headset will be supplied in a charged state and its charge level is automatically maintained so long as it is regularly docked on the charging pin on the back of the device. It should also be noted that the headset is a Sennheiser wireless device. It is supplied paired with the Tempus Pro. You cannot use different wireless headsets with the Tempus Pro and RDT recommends that you do not attempt to use the headset supplied with the Tempus Pro with any other wireless devices

(including other Tempus Pros or other communications devices such as mobile phones). Each headset is paired to only the Tempus Pro to which it is attached on delivery. While attaching the headset to other Tempus Pro units will not cause any damage, users should avoid this practise as it may cause confusion and ultimately prevent voice calls from being made when needed. If the headset is lost or is damaged, contact RDT for a replacement. RDT recommends that the Sennheiser instructions (that are provided with the Tempus) are read in addition to the instructions below. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 189 Chapter 9 Other features of the Tempus Pro Introduction The headset has 3 buttons:

Volume up Volume down Multi-function button Sennheiser Presence Sennheiser VMX200 Users should avoid using the headset speaker volume controls. The speaker volume can be controlled through the Tempus and is preset to maximum. Note Wearing the headset To put the headset on, follow the instructions given on screen. Simply put the headset into your ear (either ear). It is small and light and should not require the use of an ear hook but this can be fitted if required (see Sennheiser instruction manual provided with the Tempus). You should ensure the speaker is well seated in your ear so it feels stable. Controlling the wireless headset To use the headset:

Press the green dial button. Following the on-screen instructions, remove the headset from its dock. Following the on-screen instructions, press the Multi-function button once (for 1 second or less). The light on the headset will flash blue. The Tempus will go through a process to link to the headset via Bluetooth. Following the on-screen instructions put the headset into your ear. Following the on-screen instructions press the Connection button on the touchscreen. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 190 9.6 Connecting to an alternate location Note If you keep the talk button held down after the headset is on, you can put the headset into pairing mode. This is not desirable as it could potentially cause the headset to cease being paired with the Tempus Pro and thus prevent it from operating with the device. Pairing mode can be recognised by the indicator light slowly flashing red and then blue. If the headset is inadvertently put into pairing mode it should be placed back onto the docking pin on the Tempus to turn the headset off; the voice call should be disconnected and re-

initiated. You can check if your headset is on by pressing the talk button once. If the indicator light flashes blue, then this means the unit is on. You do not need to switch the headset off; this is achieved by docking the headset back onto the Tempus Pro. If you do wish to turn the headset off, press and hold the Multi-function button for 3 seconds until the LED flashes blue three times. Note Note If you turn the headset off during a call, you will not be able to receive the call again with the headset i.e. if you turn the headset back on you will not hear the call again. If the headset is turned off during a call, disconnect the call using the Tempus Pro and then re-initiate the connection again following the on-screen instructions. RDT recommends that users do not use the Multi-function button for any other purpose than turning the headset on (as described above). If you use the Multi-function button, then other functions and features (as described in the Sennheiser manual) of the headset can be engaged these may cause confusion. To adjust the volume during a call, press the vol+ button or vol- button on the headset as shown above. Note If you press and hold the vol- button for 1 second you will mute the headset. To release muting, quickly press the vol- button on the headset. RDT does not recommend that you use the muting function as this could cause confusion during a call. 9.6.3 Connection status indicators The connection status indicators show whether the Tempus Pro is connected to the Response Centre. There are separate indicators for the voice link and the data link. The following symbols indicate the state of the links:

Data connection started (icon will flash) Data connection to Data centre (gateway) completed (icon solid), data not picked up by Response Centre Data connection to Response Centre completed (icon solid and capital C on Connected). Voice connection in progress (icon flashing) or connected (icon solid) The words 'connected' and 'disconnected' refer to whether there is a call in progress, NOT whether the Tempus Pro phone wires are plugged in. Once the voice connection is in progress the User can hear its status through the headset e.g. ringing, connected etc. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 191 Chapter 9 Other features of the Tempus Pro WARNING When connected the patient name and age are not displayed. 9.6.4 Communications modes Tempus Pro can connect to the Response Centre using a number of wired and wireless communications interfaces e.g. Ethernet or WiFi. Note The Tempus can only be pre-set to connect to a single Response Centre. Configuring it to connect to new Response Centre requires the support of RDT. Connecting over wired interfaces such as Ethernet requires connecting the Tempus using a cable;

connecting over wireless interfaces such as WiFi require no physical connection to be made. To make it easy to switch between these types of connections, the Tempus Pro is pre-set to connect using different communication Modes. Each Mode is supported by a full set of graphical connection iAssist help processes that provide the User with instructions specific to connecting using that technology. The Tempus Pro shows what Mode it is in with a banner at the top of the Connection IAssist help process. The Tempus Pro will stay in this Mode until it has been set to another Mode (even if it has been turned off and on again). The title of the connection process is shown here, this is user configurable Press here to return to the modes menu Example Data Connection Process Follow the graphical and text instructions to set the unit up. Note that the set up instructions of any communication devices you are connecting to must be followed also. Press here to start the data connection process Tempus Pro User/Operator Manual - 41-2001EN-00 Page 192 9.6 Connecting to an alternate location Changing modes You can change the Communications Mode by pressing the Connect in other ways button. This will bring up the Communications Modes Menu. This can also be reached through the Communications Modes button in the Main Menu see 5.2.1 The main menu. The different Modes are labelled. Select them by pressing the required button Multiple Modes menus are displayed. The Tempus shows 10 Ethernet Modes and 5 WiFi modes. All are user configurable Example Modes Menu The Mode that the Tempus is set to use will be indicated with a lit bar. To change Mode, press the required Mode. The instructions for that Mode will be brought up on screen. The title of the new instructions will show what Mode the Tempus is now set to use. The Modes that are available on each Tempus Pro are dependent on the requirements of each User. Refer to the Modes Menu on your Tempus Pro for specific details of each Mode that is available. Remember that each Mode may have a different set of instructions for connecting, fault finding and repacking. Consequently, it is vital that you remember to read and follow what each iAssist help process says at all times. It is also important to remember that if one Mode cannot be used then another may be usable in its place. Once the mode is selected the Tempus will display the instructions for connecting in that mode. Changing headset settings The performance of the headset can be changed if required. The headset settings are accessed using the Headset Settings button on the Communications Settings menu see 5.2.2 Printer and Headset menu. Note The headset settings are pre-set for the best performance for use in environments with a range of ambient noise levels. Users should change the settings if they are struggling to hear or be heard. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 193 Chapter 9 Other features of the Tempus Pro 9.6.5 Interacting with the Response Centre The Response Centre Each Tempus Pro device is pre-configured to dial automatically to a specific Response Centre. The centre should be staffed 24 hours a day, 365 days a year and should always be able to receive your connection. If a connection cannot be established, you should wait a short time and attempt to connect again. Note It is the Users responsibility to ensure their Response Centre is properly staffed and equipped. When interacting with the Response Centre staff, you should also realise that they may be operating in a different time zone to the one where the incident is taking place. However, the clocks (and displayed times) of the both the Tempus Pro and the i2i software are synchronised. Remote viewing and control WARNING The alarm functions of the Tempus are intended to be used by the attendant user only. If the device is connected to a Response Centre this is for the purpose of sharing vital signs data in real time, between two users for the purpose of obtaining additional clinical support. The system is not a distributed alarm system (e.g. nurse monitoring station system) in the terms of IEC60601-1-8. The i2i system at the Response Centre is not equipped with alarm silencing or suspending controls. The Response Centre operators will have exactly the same information on their screens as displayed on the Tempus Pro. Should the Tempus Pro display change e.g. if a new help screen is brought up, new data is displayed or an error message appears, the Response Centre system will display exactly the same information a few seconds later. The only exceptions to this are when you are taking a digital picture or when you are monitoring or recording a 12 Lead ECG, in these situations the Response Centre only see that you are in the process of recording the ECG or taking the photo but they dont see the ECG or photo until it has been downloaded. WARNING Users are reminded that the i2i system at the Response Centre is not equipped with alarm silencing or suspending controls. The i2i user is able to see the alarm condition through the on-screen visual alarm manifestations but they are not provided with audible alarms (it is not a distributed alarm system) and they are not equipped with means to silence or suspend the alarms. Managing the alarm state of the product is the responsibility of the Tempus User. Note Note While the i2i will display the same information as the Tempus, user should note that the actual display size and aspect ratio of waveforms will vary slightly depending on the native resolution of the display that the i2i user has i.e. the i2i users display may have differently sized and shaped pixels to the display of the Tempus and so very minor differences may be present between the two displays. If the waveform or video stop appearing on the i2i application stop the connection and reconnect the Tempus. If the Response Centre needs to operate the Tempus Pro remotely, they should make you aware that they are activating a function of the device before they do so. Ideally the Response Centre will only take control of the Tempus Pro if the operator is having difficulty with an operation. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 194 9.7 iAssist processes 9.6.6 Recording data off-line and transmitting on-line If a connection has not been established to a Response Centre, all data for that patient can be transmitted later so long as a new patient is not admitted. Once a new patient is admitted, the recorded data cannot be transmitted to the Response Centre. For details on discharging the patient, see 9.3.3 Admitting a new patient. 9.7 iAssist processes Note The iAssist help processes on your Tempus Pro may differ from this example iAssist help process in the following sections. However, the process always follows the same key elements. Always ensure that you read the complete iAssist help process in order and do exactly what it requires. The Tempus can provide additional on-screen instructions on how to use the device. This feature is called iAssist Mode. iAssist Mode is intended to be set by more experienced users in order that they can pass the Tempus to less experienced colleagues knowing that their operation of the device will be supported by on-

screen instructions. If iAssist is activated on the Main Menu, the second ECG Lead waveform will be removed and the Plethysmogram and Capnogram will be moved up to make room for a row of graphical buttons in the bottom-most waveform of the Tempus Home Screen see 5.2.1 The main menu. The first button is the ECG button Each button is a graphical cue to allow the less experienced user to get on-screen instructions on how to deploy that particular parameter. Home Screen in iAssist Mode ECG pressing this brings up instructions on how to use the ECG Blood pressure pressing this brings up instructions on how to take non-invasive blood pressure measurements Pulse oximeter pressing this brings up instructions on how to take blood oxygen measurements Tempus Pro User/Operator Manual - 41-2001EN-00 Page 195 Chapter 9 Other features of the Tempus Pro Capnometer pressing this brings up instructions on how to take Capnometry measurements Temperature pressing this brings up instructions on how to take temperature measurements When in iAssist Mode, the Tempus Pro provides the user with complete instructions on how to use it. Every step is detailed in pictures with accompanying text instructions. There are instruction processes for everything the user will need to do to use the parameter. The example iAssist process shown below shows there are two distinct areas on the screen that give different types of information. Process Instructions - This area contains the graphical pictures and text instructions that show you how to use the device. This takes the user through each activity one or two steps at a time. Touch Screen Buttons - In this example there are two buttons at the bottom of the touchscreen. In all cases the user will press the button on the bottom right of the screen to progress onto the next step in the process. The strip shows that the number of steps in the process and the steps that are being displayed You can go back to the previous step instructions here Follow the on-

screen written and graphical instructions Press here when the instructions have been completed Example iAssist Process When in iAssist Mode, the Tempus Pro breaks all processes down into small steps. These steps are shown on the screen in one or two at a time. The user can see how many steps there are in any process by looking at the Process Ribbon near the top of the screen. In the example shown above, the screen shows that the process has 8 steps and that the device is showing steps 6-7. The user follows the instructions given on the screen, ensuring that they review both the image and the text. Once they have completed both steps they proceed onto the next steps by pressing the Next touchscreen button. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 196 9.7 iAssist processes 9.7.1 Monitoring ECG To begin monitoring an ECG, press button on the device. The first step in the ECG help process will appear. Follow the instructions provided on the iAssist help process to activate ECG. 9.7.2 Taking blood pressure measurements To take Blood Pressure measurements, press the the Blood Pressure help process will appear. button on the device. The first step in Follow the instructions provided on the iAssist help process to activate Blood Pressure. 9.7.3 Taking pulse oximetry measurements To take Pulse Oximetry measurements, press the the Pulse Oximeter help process will appear. button on the device. The first step in Follow the instructions provided on the iAssist help process to activate Pulse Oximeter. 9.7.4 Taking capnometry readings To activate the Capnometer function, press button on the device. The first step in the Capnometer help process will appear. Follow the instructions provided on the iAssist help process to activate Capnometer. 9.7.5 Taking temperature readings To activate the thermometer, press button on the device. The first instructions will be displayed. Follow the instructions provided on the iAssist help process to use the thermometer. 9.7.6 Using the camera To activate the Camera, press button on the device. The first Camera help screen will appear. A digital picture from the camera will appear on the Tempus Pro display in the position shown in the following picture. Follow the instructions provided on the iAssist help process to take a photo. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 197 Chapter 9 Other features of the Tempus Pro 9.8 View installed features Use the Main Menu option View Installed Features to view a list of features installed on Tempus Pro. 9.9 Printer maintenance 9.9.1 External printer configuration You can use an external USB printer to print patient reports see 9.1.2 Send patient data/report. To configure an external printer:

1. Select Main Menu > Printer and Headset > External Printer Settings. 2. Select the setting to change:

Printer Type - PCL3 or PCL3-GUI. Paper - A4 or Letter (8.5 x 11). 3. Press Test Page and check the resulting test print. 4. Press Back. 9.9.2 Internal printer configuration (optional) You can use the internal printer (if fitted) to print:

Waveform snapshots see 8.2.2 Waveform viewer. 12 lead ECG recordings see 6.1.6 Performing a diagnostic ECG. Note Always store the Tempus Pro with a paper roll fitted to the printer. Printing on the internal printer is not possible whilst the ultrasound is being used. To configure the internal printer:

1. Select Main Menu > Printer and Headset > Internal Printer Settings. 2. Select the setting to change:

Paper - Plain or Grid. Auto Print Snapshots - 'yes' means that waveform snapshots will be printed as soon as they are captured. 3. Press Test Page and check the resulting test print. 4. Press Back. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 198 9.9 Printer maintenance 9.9.3 Changing the paper roll (internal printer only) Note To ensure ease of access to the printer roll, place the Tempus Pro on a flat surface, lying on its front. Do not force the lid to open at an angle greater than 90 from the back of the unit. Excessive force will detach the lid from the printer body: if this happens see "9.9.4 Fitting the printer lid". To change the paper roll in the internal printer, proceed as follows:

1. Open printer lid by depressing the button in the printer housing. Open the lid to an angle not greater than 90 from the back of the unit. Do not force it to open any more than this:

2. Remove the old paper roll spindle:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 199 Chapter 9 Other features of the Tempus Pro 3. Free the end of the new roll:

4. Place the roll into the housing, with the outside face of the paper against the printer mechanism:

5. Feed in one side of the roll, then the other:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 200 6. Ensure the roll spindle is centred on the fixing springs, pull the roll to ensure it rotates freely:

9.9 Printer maintenance 7. Close the lid and press it down on both corners, listening for a click. Tear off any extra paper:

8. Set the paper type (Plain or Grid). If required, print a test page - for instruction see 9.9.2 Internal printer configuration (optional). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 201 Chapter 9 Other features of the Tempus Pro 9.9.4 Fitting the printer lid (internal printer only) If the lid becomes detached from the printer housing, refit it as follows:

1. Align the slotted ends of the lid hinges with the steel hinge pins in the printer housing:

2. Lower the lid onto the printer housing, ensuring that the top rubber seal is not trapped. Do not press the lid into position yet:

3.

(a) Hold the lid open at an angle of not more than 45 to the back of the unit.

(b) Place your thumbs on both lid hinges:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 202 4. Push the slotted ends of the lid hinges down onto the steel hinge pins in the printer housing, ensuring they both click into place. Important - ensure that the lid rotates freely on its hinges to open and close. 9.9 Printer maintenance 5. Close the lid and press it down on both corners, listening for a click:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 203 Chapter 9 Other features of the Tempus Pro 9.10 Managing Wi-Fi networks If Wi-Fi is the communication mode for your Tempus Pro, you can scan and connect to available Wi-Fi networks. Smart management of Wi-Fi enables Tempus Pro to automatically connect to any Wi-Fi network that it finds in range where the configuration details are already stored. To manage your Wi-Fi networks, proceed as follows:

Step Description Screen Go to the Main menu

. 1. In the Wireless Enabled control area, ensure that WiFi is set to 'yes'. Press Manage Wi-Fi Networks. 2. Tempus Pro displays the Manage Wi-

Fi Networks menu. It may take up to 30 seconds to scan for and display the available networks. Each network is displayed with its connection status:

Connecting... - Tempus Pro is attempting to connect to this network. Authenticated - Tempus Pro is now connected to this network. Press this button to view settings, update settings or forget the network (step 3a). Saved - Tempus Pro knows the key for this network. Press this button to connect to the network, update settings or forget the network (step 3b). Key required - Tempus Pro does not know the key for this network. Press this button to connect to the network

(step 3c). You can also connect to a hidden network (if you know its key and other settings) - press Add a Wi-Fi network (step 3d). Tempus Pro User/Operator Manual - 41-2001EN-00 Page 204 Step Description Screen 9.10 Managing Wi-Fi networks If you have selected the Authenticated network, choose an option:

View network information - view IP address, IP subnet and IP gateway/DNS. 3a. Edit Wi-Fi Settings - edit SSID, network key and hidden status. 3b. Forget Wi-Fi Network - if you forget this network the Tempus will no longer be able to connect to it automatically. Press Back. If you have selected a Saved network, choose an option:

Connect to Wi-Fi network - press this button to connect. Tempus Pro redisplays the Manage Wi-Fi Networks menu showing the status of this network as Connecting.... If connection is successful, status changes to Authenticated. Edit Wi-Fi Settings - edit SSID, network key and hidden status. Forget Wi-Fi Network - if you forget this network the Tempus will no longer be able to connect to it automatically. If you have selected a Key required network, choose this option:

Connect to Wi-Fi network:

Press this button. Enter the network key. Press Connect. 3c. Tempus Pro redisplays the Manage Wi-Fi Networks menu showing the status of this network as Connecting.... If connection is successful, status changes to Authenticated. Note: If the "Wi-Fi error"

message appears, check the connection assumptions in Edit Wi-Fi settings and try to connect again. If this does not help, press Forget Wi-

Fi network, power cycle Tempus Pro and restart the connection to the required network. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 205 Chapter 9 Other features of the Tempus Pro Step Description Screen If you have selected Add a Wi-Fi Network:

3d. Enter the SSID, network key, hidden status and other details as requested. Press Save. Press Back. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 206 10 After using the Tempus Pro 10.1 Inspecting the Tempus Pro After using the Tempus, always inspect the device, its accessories (including power supplies, mains cable, batteries and charger) for signs of damage or wear. While doing this ensure that you check the strain reliefs of cables and connectors to ensure they remain fit for use. Check that all connectors engage properly and that cable securements work acceptably. Also remember to check connector covers (if fitted) and particularly the Capnometer door, to ensure they close and latch acceptably. Inform any signs of wear, damage or malfunction to your service department. At least once per year completely inspect the whole device and in particular the mains power supply and battery charger, for signs of extreme damage. This inspection should be performed by appropriately trained and equipped personnel who are able to perform locally prescribed safety tests. In addition, RDT recommends the device is tested by an appropriately trained and equipped Electro-

Biomedical Engineer to confirm the medical and other functions of the device function within specification and within locally prescribed safety limits. Note Users should note that particular calibration curves exist for use of specific SpO2 simulators with the Tempus Masimo pulse oximeter. Please contact RDT for details. Such functional testers should not be used to determine the accuracy of the device, only its correspondence to the particular calibration curve provided by the tester. 10.2 Cleaning the Tempus Pro It is necessary to clean the Tempus Pro after use. CAUTION Note If you suspect that dirt or fluids have entered the battery compartment, see the Tempus Pro Maintenance Manual. If the Tempus is soiled, it is the users responsibility to ensure it is withdrawn from use and properly decontaminated prior to re-deployment. In this instance users are recommended to replace the handle for the appropriate part number, see 12 Accessories list of the Tempus Pro. 10.2.1 Cleaning the case of the Tempus Pro To clean the Tempus, use a clean and dry cloth using an agent from the table below. Ensure that connector pins are covered during cleaning and remain dry. Wipe off any excess cleaning agent from the device with a different clean and dry cloth. Approved Cleaning Agents:

Warm water Tempus Pro User/Operator Manual - 41-2001EN-00 Page 207 Chapter 10 After using the Tempus Pro Liquid soap Wex-cide Windex Never use any other cleaning agent than those described above. Use of more aggressive agents such as alcohols, acetone and other solvents is not permitted. The Tempus Pro instruments must be cleaned during the re-packing process. In the event of contamination of the Tempus from human fluids or other waste matter the product should be thoroughly decontaminated and disinfected. In this event the handle should be removed and discarded and replaced with a new part sourced from RDT. CAUTION If the Tempus requires cleaning, users are advised to ensure that stiff or sharp objects are NOT used to remove detritus from underneath the louvered vents in the front and rear panels of the device. Doing so could compromise the IP66 sealing of the product. The front panel vent is located where shown in the image below. The rear panel vents are located behind the accessory pockets. Front panel vent position Position of Vent 10.2.2 Cleaning the display The screen may be cleaned using a proprietary screen cleaning wipe of the type used for other LCD screens. Under no circumstances should any abrasive substance be applied to the screen. It should be noted that the anti-reflective (AR) coating of the touchscreen may be impaired if unsuitable materials are used to clean the touchscreen. The table below lists different cleaning materials and their effect on the AR coating after a 30-minute exposure under ambient conditions:

Chemicals NaOH 3% aq. solution Na4OH 3% aq. solution HCI 3% aq. solution Kitchen cleaner 5% aq. solution Glass cleaner Result Unchanged Unchanged Unchanged Unchanged Unchanged Tempus Pro User/Operator Manual - 41-2001EN-00 Page 208 10.3 Disposal at end of life CAUTION Under no circumstances should any abrasive substance be applied to the screen. 10.2.3 Cleaning connectors If connectors are wet, they should be rinsed with tap water and then dried. All solid material (e.g. dust or sand), should be removed with compressed air. Cables or connectors with corroded contacts should be replaced. 10.2.4 Cleaning the NIBP cuffs and hose The NIBP hose and reusable cuffs should be cleaned with a clean cloth after use with a disinfectant such as Clorox (1:10 solution). Ensure that any cleaning solution does not enter the hose or bladder. Ensure the cuff is completely dry before it is reused. The cuffs may be machine washed at 40-50 C (after plugging the air connector to prevent water entering the bladder). 10.2.5 Cleaning the SpO2, ECG and invasive pressure cables Clean the sensor cables with a clean cloth after use with a disinfectant such as Clorox (1:10 solution). Do not immerse any cables. Ensure the cables are completely dry before they are reused. CAUTION No cables or parts of the Tempus should be sterilised using any process (Steam, EO, Radiation etc.). Never immerse ECG cables, doing so could reduce the performance of defibrillation protection devices within the cable 10.2.6 Cleaning the battery contacts Remove the battery once a week. Inspect the electrical contacts of the Tempus Pro battery compartment and of the battery itself. If any battery contacts are dirty, clean them as described:

Approved cleaning agents:

Isopropyl alcohol electronic cleaning solvent. Cleaning:

1. Moisten a clean, dry cloth with the approved cleaning agent and wipe the battery contacts. 2. Wipe off any excess cleaning agent with a clean, dry cloth. 3. Refit the battery. 10.3 Disposal at end of life The WEEE logo on the Tempus and its battery refers to the EU Directive on Waste Electrical and Electronic Equipment (WEEE). This Directive entered into force as European law on 13th February 2003; it resulted in a major change in the treatment of electrical equipment at end-of-life. The purpose of this Directive is, as a first priority, the prevention of WEEE, and in addition, to promote the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 209 Chapter 10 After using the Tempus Pro The symbol indicates that this product must not be disposed of or dumped with household waste. The owner of the equipment is liable to dispose of all electronic or electrical waste equipment by delivering to the specified collection point for recycling of such hazardous waste, collection and proper recovery of electronic and electrical waste equipment at the time of disposal will allow the producer to help conserve natural resources. Recycling of the electronic and electrical waste equipment will ensure safety of human health and the environment. For more information about electronic and electrical waste equipment disposal, recovery and collection points, please contact your local, waste disposal service or producer / distributor of this equipment. Note Tempus batteries must be disposed of in accordance with local regulations. Batteries should not be crushed or incinerated as they could present a risk of fire or explosion. Batteries should be handed to an appropriate organisation that is competent in the disposal of such devices; this must be done in accordance with local regulations. 10.3.1 Disposal of single use devices Any accessories that are designated as single-use devices must be discarded after use. No particular precautions are required when disposing of these items provided that they are not contaminated with bodily fluids. In case of such contamination, the items could present a bio-hazard and therefore should be disposed of in accordance with local regulations governing such matters. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 210 11 Maintenance, servicing and troubleshooting The Tempus Pro is designed to be as maintenance-free as possible. The only user-replaceable and user-

serviceable parts in the Tempus Pro are those listed in this section of the manual. More details on maintenance are given in the Tempus Pro Maintenance Manual, which is available from RDT, see RDT contact details. The Tempus Pro Maintenance Manual contains the necessary technical information, schematics, parts designation and process description for specified maintenance and testing to be performed. WARNING Do not open the battery case or in any way disassemble, modify or repair the battery. CAUTION All leads, cables and accessories should be checked before and after use to ensure that such parts are not subject to wear, fraying, tears, knots or other signs of damage. Damaged or worn parts should be replaced. CAUTION The ECG cables contain components to protect against the effect of a defibrillator. The ECG cables should be measured on an annual basis (or more frequently at the users discretion if they are subject to a high number of defibrillation discharges) to ensure that they retain a resistance of 1 k 10% as per AAMI EC53. Cables should be replaced if this resistance is not maintained. Note If the Tempus Pro is no longer serviceable and is beyond repair, it may be scrapped. Scrapping the device and its accessories must be performed in compliance with applicable local regulations. It should be noted that special conditions may apply to the rechargeable battery if it is required to be scrapped. The battery should be discharged before scrapping and should not be crushed or incinerated. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 211 Chapter 11 Maintenance, servicing and troubleshooting 11.1 Tempus Pro battery 11.1.1 The battery The Tempus Pro contains a removable, rechargeable battery. Example of the Battery Front In normal usage, the rechargeable battery provides power for at least 9 hours' continuous use when fully charged. Example of the Battery Rear Note Note Assessment of use is based on projections of reasonable device usage within a patient incident made by RDT. Do not attempt to fit batteries from previous RDT products (Tempus IC or Tempus IC Professional) into the Tempus Pro, they will not fit. Every battery is provided with an integral battery life indicator which is also visible through the front panel of the case. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 212 11.1 Tempus Pro battery The battery life should be monitored periodically when the device is in storage and also before and after use. RDT recommends that the battery charge status should be checked at least every month and recharged if necessary. If the device is being used regularly then the battery should be checked, weekly or daily depending on the frequency of use. RDT also recommends that the battery be completely discharged and recharged once a year. The User should remember that battery capacity of older batteries will not be the same as new batteries. Note Note By monitoring the remaining battery life, situations where the battery is too weak to power the Tempus Pro for the duration of an incident can be avoided. If the battery strength indicator shows less than 25% power remaining, you should change the battery if possible to ensure that there is adequate power for the next time it is needed. Using the battery down to the point where it is completely empty will not cause any hazards or damage to the system. The power of the battery can be extended by enabling a screen-saving feature on the Tempus. Enabling this feature will make the display switch off if 5 minutes pass with no operator intervention or alarms triggering. The Tempus will remain on and performing any monitoring function it has been set to do. If any patient or technical alarms occur, the Tempus display will come back on and the alarm functions sound as normal. While the display is off, if any operator controls are used then the display will come back in immediately. Using the power save feature will enable the battery life to be extended significantly. To enable this feature, go to the Display Menu and then turn Power Save to on see 9.2.7 Power save feature. Checking the charge of the battery The charge state of the battery can be obtained by pressing the button on the front

. The battery is provided with 4 charge state LEDs. Pressing the button will light one or more lights. Each light corresponds to 25% of the charge state of the battery in the order (from highest to lowest):

Four green LEDs 76-100%

Three green LEDs 51-75%

Two green LEDs 26-50%

One green LED 1-25%

One green flashing LED less than 10%

No LEDs no power due to deep discharge Battery status is always displayed in the status bar see 5.1.3 Battery status indicator. When the battery is low it should be recharged soon after use. Starting a Tempus on an empty battery or leaving batteries in a low or empty state for prolonged periods may put the battery into a deep-discharged state. In this state the battery LEDs will not light and the battery will require a prolonged period on charge in order to return it to normal operation. If none of the LEDs light, then the battery may have been deep-discharged. It should be left on-charge on an external charger for 24 hours to bring the battery out of this state. CAUTION CAUTION These will light cumulatively when the battery button is pressed i.e. only the one green light will light if the charge state is 1-25% after which the 2nd green light will light as well. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 213 Chapter 11 Maintenance, servicing and troubleshooting The Tempus Pro does not need to be turned on to check the battery. If batteries do not retain their charge state, users should try charging them fully on an external charger. As batteries become old and over many charge/discharge cycles, users should expect to see a reduction in their capacity. Such batteries should be replaced at the users discretion. 11.1.2 Removing the battery from the Tempus Pro WARNING WARNING Note Do not short-circuit the terminals of any battery. A short circuit can occur if the battery terminals come into contact with any metal or other electrically conductive object. The battery may be irreversibly damaged if it is short-circuited. Ensure the latches on both sides of the battery are fully engaged prior to using the Tempus - an incorrectly fitted battery could result in the Tempus losing power during use. Before removing the battery, you must switch off the Tempus Pro by pressing the power button. If necessary, you can force a hard shut-down by pressing and holding the power button for 10 seconds. Remember that the battery cannot be removed until the lamp on the front panel has gone out. The Tempus Pro should not be used without the battery fitted. To replace the battery:

First check the replacement battery has sufficient charge by checking its indicator. Next, ensure the Tempus is switched off. Then remove the battery by squeezing the two latches inwards and then pull the battery away. Example of the Battery Indicator Tempus Pro User/Operator Manual - 41-2001EN-00 Page 214 11.1 Tempus Pro battery Battery Removal Slide the new battery all the way into the Tempus until it clicks into place on both sides. Battery Insertion 11.1.3 Charging the battery The battery can be charged either when it is fitted to the Tempus Pro or when it is removed from the separate battery charger. WARNING CAUTION CAUTION Note Do not attempt to charge the battery using any charger other than those supplied by RDT. When the battery is low it should be recharged soon after use. Starting a Tempus on an empty battery or leaving batteries in a low or empty state for prolonged periods may put the battery into a deep-discharged state. In this state the battery LEDs will not light and the battery will require a prolonged period on charge in order to return it to normal operation. If none of the LEDs light, then the battery may have been deep-discharged. It should be left on-charge on an external charger for 24 hours to bring the battery out of this state. Users are reminded that the Tempus (when using its external power supply) should not be used to recharge batteries above 40C see 14.2 Physical characteristics and environmental specifications. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 215 Chapter 11 Maintenance, servicing and troubleshooting Charging the battery when attached to the Tempus Pro When fitted to the Tempus Pro, the battery can be charged by connecting the power supply (part number 01-2049) to the connector on the right hand side of the Tempus. The PSU Plug Attached to the Tempus Pro Connector CAUTION If the Tempus is powered using the mains power supply, ensure the mains power supply is accessible so the mains lead can be disconnected in the event that the device needs to be isolated from mains power. The means of isolation of mains power is to disconnect the mains lead from the power supply. CAUTION Where the integrity of the external protective conductor (earth) in the installation or its arrangement is in doubt, equipment shall be operated from its internal electrical power source. Note Interruption of the supply mains for short periods e.g. 30 seconds, will not cause a problem, as the Tempus will automatically switch to battery power. In the event that a battery is not fitted (or is completely flat) the device will shut down immediately. In this case no patient data will be lost. If the device is restarted within 30 seconds it will resume with all patient settings unchanged. If power is resupplied after that it will resume as normal with default settings in place. In this case the user can switch back to monitoring the previous patient

(and continue completing their record) as described in sections 4.3.3 and 9.3.4. When the power supply is attached to the Tempus Pro, the green power light on the Tempus Pro front panel will turn on. If a battery is attached the green charge light will flash. The lights on the battery will light solidly up to the charge state of the battery at the time. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 216 Mains power supply indicator 11.1 Tempus Pro battery Battery Charging Indicator Battery check button Battery Charge indicators CAUTION When the battery is low it should be recharged soon after use. Starting a Tempus on an empty battery or leaving batteries in a low or empty state for prolonged periods may put the battery into a deep-discharged state. In this state the battery LEDs will not light and the battery will require a prolonged period on charge in order to return it to normal operation. CAUTION If none of the LEDs light, then the battery may have been deep-discharged. It should be left on-charge attached to a battery charger (separate from the Tempus) for 24 hours to bring the battery out of this state. Note Charge times of the battery will vary depending on the how the Tempus Pro is being used. If the Tempus is switched off charging will be faster than if the Tempus is on and all features are being used. Charging a completely empty battery will take 6 hours when the Tempus Pro is switched off. Using the battery charger When the battery is separate from the Tempus Pro, the battery may be charged by connecting it to the battery charger (part number 01-1012). To attach the charger to the battery, the clip must be firmly pressed onto the connections of the battery. Note that the clip of the charger can only be connected to the battery in one way. Clip the charger to the battery (the clip only attaches in one way). The Battery Connector Attached to the Battery Tempus Pro User/Operator Manual - 41-2001EN-00 Page 217 Chapter 11 Maintenance, servicing and troubleshooting Attach the charger to the main supply. The LED on the charger will light orange (for approximately 0-85% charge), change to yellow during charging (at approximately 86-100% charge) and will turn green when finished. If the battery is only partially discharged, then the LED may start on yellow. CAUTION When the battery is low it should be recharged soon after use. Starting a Tempus on an empty battery or leaving batteries in a low or empty state for prolonged periods may put the battery into a deep-discharged state. In this state the battery LEDs will not light and the battery will require a prolonged period on charge in order to return it to normal operation. CAUTION If none of the LEDs light, then the battery may have been deep-discharged. It should be left on-charge attached to a battery charger (separate from the Tempus) for 24 hours to bring the battery out of this state. Note Battery charger is rated at 100-240 V 50-60 Hz 0.9 A. Recharging the battery takes up to 6 hours for a fully discharged battery. Charging to 90%

capacity takes 5 hours. 11.2 Wireless headset battery The headset contains a rechargeable battery. The battery of the headset is not user-replaceable and does not require user intervention. In the unlikely event that the headsets battery becomes completely exhausted and can no longer hold charge, a replacement headset can be purchased. 11.2.1 Charging the headset RDT do not supply a separate charger for the headset. The charger is built into the Tempus Pro. You must follow the repacking instructions provided by the Tempus Pro on screen. These will instruct you to clean the headset after use and to replace it on its docking pin before shutting down. If you do not replace the headset, then the Tempus will show an error advising that the headset should be refitted. Placing the headset onto the docking pin enables the Tempus Pro to recharge it. The Tempus Pro recharges the headset for up to 9 hours (approx.) every time the headset is replaced. The charging cycle will continue regardless if the Tempus Pro is switched on or off. Charging is started as soon as the headset is fitted to the docking pin. The indicator light on the headset will light red for the duration of the charging process. Once the headset is charged its LED will flash blue every 5 seconds. The indicator lights will go off when charge cycle is complete (9 hours). In addition, the Tempus Pro will top up the charge of the headset approximately every 97 days. This occurs when the Tempus is switched off and lasts for up to 9 hours (approximately). CAUTION CAUTION Always maintain a level of at least 10% in the Tempus battery. Leaving the Tempus battery in a low charge state can risk it being depleted by the headset charging process. Do not attempt to charge the headset using any other charging device. This will automatically suspend the warranty and could be dangerous. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 218 11.3 Daily checks 11.2.2 General guidelines for safe use Do not drop or try to alter the shape of your headset. Do not expose the headset to liquid or moisture. Unlike the Tempus, the headset has no protection against ingress of solids or liquids. Do not expose your headset to extreme temperatures. The temperature range of the headset is 10-40 C. Do not try to disassembly your headset. Service and Maintenance can only be performed by RDT. Do not let children play with the headset since it contains small parts that could become detached and create a choking hazard. WARNING CAUTION Danger of explosion if battery is incorrectly replaced. Do not attempt to repair or replace the battery. If the battery is worn out, a new headset is required from RDT. Dispose of the headset in accordance with local regulations. Do not dispose as household waste. The user manual for the Sennheiser headset is supplied on the same CD-ROM as this manual. Details from that manual have been reproduced in this section courtesy of Sennheiser. 11.2.3 Disposal of batteries Dispose of batteries in accordance with the applicable local regulations (these can vary from country to country). Note In most countries, it is illegal to dispose of used batteries in residual waste (landfill). Users are required to dispose of used batteries through the proper channels, for example through not-for-profit organisations mandated by local governments. 11.3 Daily checks RDT recommends that the following daily checks are performed on the Tempus, its cables and accessories:

Ensure they are clean (with no fluid spills) and free of visible damage. Clean and replace as required. Check for signs of damage, excessive wear (cuts in insulation, fraying, broken wires, dirty or bent connector pins). Replace if damaged. Ensure that the device is equipped with appropriate quantities of all disposable supplies (e.g. ECG monitoring electrodes etc.). Ensure that any accessories or consumables are within the shelf life printed on their packages. Ensure that the internal printer (if fitted) contains sufficient paper for at least one day's use. Verify that a charged battery is fully inserted into the Tempus. Ensure the Tempus powers on and that all controls (as described in section 5.1) operate as described. Ideally ensure that a fully charged spare battery is available. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 219 Chapter 11 Maintenance, servicing and troubleshooting 11.4 Weekly checks RDT recommends that the following weekly checks are performed on the Tempus:

CAUTION To prevent battery failure, perform this check every week when the Tempus Pro is in use. Remove the battery from the Tempus Pro and inspect its contacts. If contacts are damaged, replace the battery. If contacts are dirty, clean them - see "1.1.6 Cleaning the battery contacts". Perform a test print. 11.5 Troubleshooting Occasionally, problems may occur with the Tempus Pro. Operator error, sensor problems or a failure within the Tempus Pro could cause these problems. In most instances, the Tempus Pro will display an error message on the screen. This section describes the possible error messages and what they mean. All of the error messages take the form of a window which appears in the middle of the screen. The window contains the following text:

A title which identifies the sensor or system which is having trouble;

A description of the problem;

The effect that the error will have on the performance of the Tempus;

Which button to press to clear the error message off the screen. CAUTION In the event that the Tempus Pro displays an error that is not described within this manual e.g. application errors, turn the Tempus Pro off and then on again. This should clear the error and allow normal operation to resume. Do not continue to use the device if such an error is displayed. If symptoms persist, please contact RDT. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 220 12 Accessories list of the Tempus Pro 12.1 Parts list The following user-replaceable accessories and consumables are available from RDT:

12.1.1 Temperature accessories Product name & description YSI-400 Series Reusable 401AC ContactTemp Probe Autoclavable YSI-400 Series Disposable 4492 12hr Contact Temp Probe YSI-400 Series 4940 Contact Temperature Adaptor Cable 12.1.2 Invasive pressure accessories Product name & description Part numbers 01-2048 and 01-2052 connect directly to the Tempus Pro:

Invasive Pressure Adaptor 2 Channel - Utah Deltran 8 ft Invasive Pressure Cable 2 Channel - Edwards TruWave 8ft Part number 01-2153 01-2078 01-2079 Part number 01-2048 01-2052 Part number 01-2113 and the Fogg adapter cables connect to the Tempus Pro only via the universal cable (part number 01-2108). Part number 01-2108 accepts up to two adaptor cables for two IBP channels:

Tempus Pro 2-Channel Invasive Pressure Universal Cable Transpac & Art-Line Transducer Adaptor Cable 2 Channel Invasive Pressure Module 01-2108 01-2113 01-2017 The following invasive pressure transducers are approved for use with the Tempus Pro:

Transducer manufacturer Transducer model ICU Medical (Abbott) Transpac IV or IT Biometrix Smiths-Medical (Medex) Smiths-Medical (Medex) Art-Line TranStar LogiCal Adaptor cable RDT P/N: 01-2113 RDT P/N: 01-2113 RDT P/N: 01-2113 Fogg P/N: 0386-2516:L16 Merit Medical (Argon Medical / BD) Meritrans / DTXPlus Fogg P/N: 0444-2516:L16 Codan PVB (ITL Healthcare) Xtrans (DPT 9000) Codan PVB (ITL Healthcare) DPT-6000 Fogg P/N: 0461-2516:L16 Fogg P/N: 0460-2516:L16 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 221 Chapter 12 Accessories list of the Tempus Pro Transducer manufacturer Transducer model Adaptor cable Utah Medical Biosensors International Biosensors International Edwards Lifesciences (Baxter) Deltran Biotrans Accutrans TruWave Fogg P/N: 0412-2516:L16 Fogg P/N: 0412-2516:L16 Fogg P/N: 0412-2516:L16 Fogg P/N: 0395-2516:L16 Fluke Biomedical ProSim 8 Vital Signs Simulator Fogg P/N: 0450-2516:L16 12.1.3 Non-invasive blood pressure accessories Product name & description Part number Tempus Blood Pressure Cuff adult cuff (23 33 cm) Tempus Blood Pressure Cuff large adult cuff (31 40 cm) Tempus Blood Pressure Cuff child cuff (12 19 cm) Tempus Blood Pressure Cuff small adult cuff (17-25cm) Tempus Blood Pressure Cuff infant (8 - 13 cm) Tempus Blood Pressure Cuff adult thigh cuff (38 50 cm) Tempus Neonate Patient Hose Adaptor CPC/Luer Tempus Blood Pressure Cuff neonate cuff (3 6 cm) Single Use (Box of 20) Tempus Blood Pressure Cuff neonate cuff (4 8 cm) Single Use (Box of 20) Tempus Blood Pressure Cuff neonate cuff (6 11 cm) Single Use (Box of 20) Tempus Blood Pressure Cuff neonate cuff (7 13 cm) Single Use (Box of 20) Tempus Blood Pressure Cuff neonate cuff (8 15 cm) Single Use (Box of 20) Tempus Blood Pressure Hose 4ft Tempus Pro NIBP Cuff Kit (adult, large adult, thigh and child cuffs) Tempus Pro Blood Pressure Hose 8ft NIBP Infant Disposable Cuff (Box of 20) NIBP Child Disposable Cuff (Box of 20) NIBP Small Adult Disposable Cuff (Box of 20) NIBP Adult Disposable Cuff (Box of 20) NIBP Large Adult Disposable Cuff (Box of 20) NIBP Thigh Disposable Cuff (Box of 20) 12.1.4 Masimo accessories Product name & description MasimoSET Rainbow cables MasimoSET Rainbow Patient Cable 12 ft 25-Pin R/A RC12 RA MasimoSET Rainbow Patient Cable 4ft 25-Pin R/A RC4 RA Masimo Rainbow DCI Masimo Rainbow DCI Adt 3ft (SpO2, SpCO, SpMet) [1] - Clip Masimo Rainbow DCI SC-400 Adt 3ft (SpO2, SpHb, SpMET) [1] - Clip Tempus Pro User/Operator Manual - 41-2001EN-00 Page 222 01-1002 01-1003 01-1004 01-2119 01-2021 01-1032 01-2067 01-2030 01-2031 01-2032 01-2033 01-2034 01-1006 01-2155 01-2074 01-2230 01-2231 01-2232 01-2233 01-2234 01-2235 Part number 01-2138 01-2088 01-2086 01-2092 Product name & description Masimo Rainbow DCIP Masimo Rainbow DCIP SC-400 Ped 3ft (SpO2, SPCO, SpMet)[1] - Clip Masimo Rainbow DCIP Ped 3ft (SpO2, SpCO, SpMet) [1] - Clip Masimo Rainbow R1 Masimo Rainbow R1 25 Adt 1ft (SpO2, SpHb, SpMET) [10] - Adh Masimo Rainbow R1 20 Ped 1ft (SpO2, SpHb, SpMET) [10] - Adh Masimo Rainbow R1 20L Inf 1ft (SpO2, SpHb, SpMET) [10] - Adh Masimo Rainbow R1 25L Neo/Adt 1ft (SpO2, SpHb, SpMET) [10] - Adh Masimo Rainbow R20 Masimo Rainbow R20 Ped 1ft (SpO2, SpCO, SpMET) [10] - Adh Masimo Rainbow R20-L Inf 1ft (SpO2, SpCO, SpMET) [10] - Adh Masimo Rainbow R25 Masimo Rainbow R25 Adt 1ft (SpO2, SpCO, SpMET) [10] - Adh Masimo Rainbow R25-L Neo/Adt 1ft (SpO2, SpCO, SpMET) [10] - Adh MasimoSET M-LNCS MasimoSET M-LNCS DBI Adt SpO2 Reusable Sensor [1] - Boot MasimoSET M-LNCS Adtx-3 Adult Sensor (20 box) MasimoSET M-LNCS Neo-3 Neonatal/Adult Sensor (20 box) MasimoSET M-LNCS Pdtx-3 Ped 3ft [20] - Adh MasimoSET M-LNCS DCI Adt 3ft [1] - Clip MasimoSET M-LNCS DCIP Ped 3ft [1] - Clip MasimoSET M-LNCS INF-3 Inf 3ft [20] - Adh MasimoSET M-LNCS NEOPT-3 Neo 3ft [20 ] - Adh MasimoSET Rainbow Sample Pk (All M-LNCS-Adtx-3, pdtx-3, Neo-3) Masimo E1 (Adult Single Use Ear Sensor) 12.1.5 Masimo Rainbow field upgrades Product name & description Masimo Rbow Total Haemoglobin (SpHb+SpOC) Field License Kit Masimo Rbow Methaemoglobin (SpMet) Field License Kit Masimo Rbow Carboxyhaemoglobin (SpCO) Field License Kit Masimo Rbow Pleth Variability Index (PVI) Field License Kit 12.1.6 Ultrasound accessories Product name & description Tempus Pro USB 3.5 MHz General Abdominal Ultrasound Probe (GP) Tempus Pro USB 7.5 MHz Vascular Ultrasound Probe (LP) 12.1 Parts list Part number 01-2136 01-2137 01-2128 01-2129 01-2130 01-2131 01-2133 01-2134 01-2132 01-2135 01-2089 01-2090 01-2091 01-2095 01-2123 01-2124 01-2126 01-2127 01-2140 01-2205 Part number 01-2328 01-2329 01-2330 01-2331 Part number 01-2008 01-2042 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 223 Chapter 12 Accessories list of the Tempus Pro 12.1.7 Video laryngoscope accessories Product name & description Tempus Pro USB C-MAC S Imager Video Laryngoscope Video Laryngoscope Single Use D blade (pack of 10) Video Laryngoscope Single Use Size 3 Macintosh blade (pack of 10) Video Laryngoscope Single Use Size 4 Macintosh blade (pack of 10) 12.1.8 Capnometer accessories Product name & description Smart CapnoLine Plus Adult/Intermediate 02 25UN (P/N 015018) Smart CapnoLine Pediatric 02 25units (P/N 015027) VitaLine H Set Adult/Pediatric 25units (P/N 015026) FilterLine H Set Adult/Pediatric 25units (P/N 015016) FilterLine Set Adult/Pediatric 25units (P/N 015021) FilterLine H Set Infant/Neonates 25units (P/N 015028) Filter Set ADU/PED 25UN Smart CapnoLine Plus Adult/Intermediate 02 25UN (P/N009822) Smart CapnoLine 02 PED 25UN Smart CapnoLine Pediatric 02 25units (P/N007269) VitaLine H Set Adult/Pediatric 25units (P/N010787) FilterLine H Set Adult/Pediatric 25units (P/NXS04624) FilterLine H Set Infant/Neonates 25 units (P/N006324) 12.1.9 Electrocardiogram accessories Product name & description Tempus Pro 3-Lead ECG Cable (AAMI) 8 ft Tempus Pro 5-Lead ECG Cable (AAMI) 8 ft Tempus Pro 12 Lead ECG Cable (AAMI) 8 ft Tempus Pro 5-Lead ECG Cable (AAMI) 10ft. Tempus Pro 3-Lead Neonatal ECG Cable (AAMI) 6ft Tempus Pro 4-Lead ECG Modular Trunk Cable (AAMI) 8 ft Tempus Pro 6-Lead ECG Limb Leads for Modular Cable (AAMI) Tempus Pro 12-Lead (4+6) ECG Modular Cable (AAMI) 8 ft Tempus Pro 3-Lead ECG Cable (IEC) 8 ft Tempus Pro 5-Lead ECG Cable (IEC) 8 ft Tempus Pro 12 Lead ECG Cable (IEC) 8 ft Tempus Pro 3-Lead Neonatal ECG Cable (IEC) 6ft Tempus Pro 4-Lead ECG Modular Cable (IEC) 8 ft Tempus Pro 6-Lead ECG Limb Leads for Modular Cable (IEC) Tempus Pro User/Operator Manual - 41-2001EN-00 Page 224 Part number 01-2044 01-2063 01-2010 01-2011 Part number 01-2143 01-2144 01-2145 01-2146 01-2147 01-2148 01-2150 01-2151 01-2247 01-2248 01-2249 01-2250 01-2252 Part number 01-2068 01-2069 01-2070 01-2084 01-2203 01-2177 01-2179 01-2182 01-2071 01-2072 01-2073 01-2202 01-2181 01-2183 Product name & description Tempus Pro 12-Lead (4+6) ECG Modular Cable (IEC) 8 ft Ambu BlueSensor 'T' Adult Foam ECG Electrode - 10 Pack Ambu BlueSensor R 25units (P/N 1559024) 12.1 Parts list Part number 01-2178 01-2080 01-2152 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 225 Chapter 12 Accessories list of the Tempus Pro 12.1.10 Power and charging accessories Product name & description Part number Tempus Lithium-ion Battery one supplied with unit Tempus Mains Power Supply (PSU) one supplied with unit When ordering a PSU, select the mains cable for the country of operation:

Switzerland UK Euro/Schuko USA Australia Nigeria (as per UK) Israel South Africa Tempus Battery Charger (including 2-core figure 8 mains cable) 01-2051 01-2049 01-2058 01-2056 01-2057 01-2055 01-2060 01-2056 01-2062 01-2054 01-1012 When ordering a battery charger, select the mains cable for the country of operation:

Switzerland UK Euro/Schuko USA Australia Nigeria (as per UK) Israel South Africa Tempus DC Vehicle Power Supply 01-2059 01-2159 01-2160 01-2161 01-2061 01-2159 01-2160 01-2162 01-2053 12.1.11 Tempus Pro ReachBak real-time telemedicine accessories Product name & description Sennheiser Presence Bluetooth Headset (Tempus Pro Kit) Tempus Wired Headset Tempus Ethernet Cable Tempus Pro Tactical Headset Adaptor Cable 12.1.12 Miscellaneous accessories Product name & description Tempus Pro Litter Mount Tempus Pro Hard Transit Case Tempus Soft Transit Bag Tempus to Tempus USB Data Cable Tempus Pro User/Operator Manual - 41-2001EN-00 Page 226 Part number 01-2254 01-1019 01-2025 01-2041 Part number 01-2035 01-2400 01-2037 01-2243 Product name & description Tempus Pro SMART mount (order PSU and power cable separately) Tempus Pro Printer paper blank 100mm (1x roll) Tempus Pro Printer paper with grid 100mm (1x roll) Tempus Pro shoulder strap (with locking mech) and 20G fixings kit Tempus Pro shoulder strap only (with locking mech) Tempus Pro Left Pouch with partition (medical side) 12.1.13 Anaesthetic gas monitoring accessories Product name & description ISA OR+ sidestream Analyser Tempus to ISA OR+ adaptor cable Nomoline 2.0m (Box of 25) Sampling line with male luer lock connector, single-patient use, Adult/Pediatric/Infant. Requires T adaptor Nomoline Adapter 0.1m (Box of 25) Sampling line with female luer lock connector. Adult/Pediatric/Infant. Requires Nomo Extension and T adaptor Nomoline Airway Adapter Set 2.0m (Box of 20) Sampling line with straight airway adapter, single-patient use, Adult/Pediatric Nomo Extension 2.0m (Box of 25) Sampling line with male luer lock connector Nomo Extension 3.0m (Box of 25) Sampling line with male luer lock connector 12.1 Parts list Part number 01-2244 01-2184 01-2186 01-2197 01-2200 01-2241 Part number 01-2167 01-2168 01-2169 01-2170 01-2171 01-2172 01-2173 T-adapter (Box of 25) Airway adapter with female luer lock connector, Adult/Pediatric 01-2174 AA gas exhaust port kit (Masimo #4409) ISA OR+ Ferno Mount Bracket 12.1.14 Corsium Crew accessories Product name & description Extended Display Tablet Cable (USB-A to USB-C) 12.1.15 Manuals and software accessories Product name & description Tempus Pro User Manual Set (CD-ROM) includes Configuration Utility software Tempus Pro Maintenance Manual CD-ROM) 01-2255 01-2258 Part number 01-2252 Part number 43-2001 43-2003 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 227 Chapter 12 Accessories list of the Tempus Pro Tempus Pro User/Operator Manual - 41-2001EN-00 Page 228 13 Configuring the Tempus Pro For information on configuring communications settings and pairing Bluetooth peripherals, see the Tempus Pro Maintenance Manual. 13.1 Demonstration and training The Tempus can be set so that it can be used in a training environment. Once set for this purpose, the Tempus can simulate:

All medical readings including ECG monitoring and recording - in this case the readings are randomly generated by the Tempus regardless of whether a patient is connected or not;

All other features such as the transmission of photos, videos, GPS positioning etc. in this case the readings are randomly generated by the Tempus;

Data and voice connections where the device simulates the appearance of a connection even when none has been made. WARNING Training and demonstration features are only for use in non-clinical settings i.e. training environments. Activation of these features in clinical settings could lead to confusion of the patients real vital signs. From the Main Menu, press Demonstration and Training button - the Tempus will display a caution. Demonstration and Training Caution Clearing this message brings up the Demonstration and Training menu. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 229 Chapter 13 Configuring the Tempus Pro Pressing here brings up the Training Modes Menu. This gives a range of communication modes for use in training, in which the Tempus simulates a full data and voice connection but does not require any real equipment to connect to Pressing here turns ALL the medical and non-

medical readings to demo mode all readings will be simulated Demonstration and Training Menu If the Tempus is set to operate in Demonstration Mode, there will be a label Demo placed on the home screen and on the 12 Lead ECG recording screen (where the 50/60Hz mains filter buttons would normally be). If the Tempus is put into a Training Communications Mode, this will be indicated by the word Training to the left of the iAssist connection process instruction. In either case, the Tempus can be put back into normal operational mode by returning to the Demonstration and Training Menu and resetting Demo Mode to Off. The correct communications mode can be reset by accessing the Communications Mode Menu from the Main Menu. If a Tempus is set into either Demonstration or Training mode, it will remain set in this way after the power has been cycled and after a new patient has been admitted. WARNING Tempus Pro User/Operator Manual - 41-2001EN-00 Page 230 14 Specifications and standards 14.1 Specifications Note that all figures quoted are based on room temperature, pressure and humidity unless otherwise stated. 14.1.1 ECG monitoring Note These specifications relate to the performance of the product when it it is configured to display only one or two ECG waveforms, for example when the default home screen is selected. Regulatory standard Meets ANSI/AAMI EC13:2007 & IEC60601-2-25:2011 Cable Gain/Sensitivity Input Range Input Impedance DC Offset Time bases For use with RDTs proprietary 3-, 4-, 5- and 12-lead cables with 4mm snap disposable electrodes 2, 4, 5, 10 (default), 1, 20, 30 & 50 mm/mV (scale 8:10) 5 mV

>100 M 300 mVdc 12.5, 25, 50 mm/s Aspect ratio range 5:50 20:12.5 (mm/mV : mm/s) (scale 8:10) Heart rate detection range 30 300 bpm Accuracy Acquisition sample rate 3%

500 Hz Monitoring bandwidth 0.5 Hz 35 Hz : Monitor Frequency response Defibrillator protection Electrosurgery protection Common Mode Rejection Leads Off Indicators Permanent Filters 0.05 Hz 150 Hz : Diagnostic 0.05 Hz 35 Hz: Filtered diagnostic 0.05 to 175 Hz 3 dB Patient leads are isolated from system and operator, with 5kV protection Protected 95 dB Connection status for each lead is shown on acquisition screen High Pass: 0.05 Hz 1st order Tempus Pro User/Operator Manual - 41-2001EN-00 Page 231 Chapter 14 Specifications and standards Notch filter (Mains Noise Rejection) 50 Hz 4th order Butterworth, Low Pass: 150 Hz 1st order Baseline Wander: Baseline reset by adaptive zeroing algorithm 49.1Hz - 50.9 Hz, 60 Hz 4th order Butterworth, 59.1 Hz - 60.9 Hz Low pass (Muscle Artifact Filter) 35 Hz 4th order ST measurement range

-10 mm to 10 mm (-1 to 1 mV) ST accuracy ST resolution 0.53 mm (53 uV) 0.1 mm ST measurement definition J+80 ms (for heart rates < 115 bpm) J+60 ms (for heart rates > 115 bpm) ISO electric line taken from PQ segment QT measurement range 10 ms - 1990 ms QT accuracy 25 ms mean QT resolution Compliance 30 ms standard deviation 1 ms IEC60601-2-25:2011 AAMI EC57 14.1.2 12-lead diagnostic ECG viewing and recording These specifications relate to the performance of the product when it is configured to display and record the 12 lead diagnostic ECG view. Note Regulatory standard Cable Gain/Sensitivity Input Range Input Impedance DC Offset Acquisition sample rate Diagnostic bandwidth Meets ANSI/AAMI EC11:1991 inc R:2001 & IEC60601-2-

27:2011 For use with RDTs proprietary 12 lead (10 wire) cable with 4mm snap disposable electrodes 2, 4, 5, 10 (default), 1, 20, 30 & 50 mm/mV 5 mV

>100 M 300 mVdc 500 Hz 0.05 Hz 40 Hz : Filtered diagnostic 0.05 Hz 175 Hz : Diagnostic Note ECG tested at 150 Hz per EC11 and with a 175 Hz 3dB bandwidth measurement. Frequency response 0.05 to 175 Hz 3dB Tempus Pro User/Operator Manual - 41-2001EN-00 Page 232 14.1 Specifications Defibrillator protection Electrosurgery protection Common Mode Rejection Leads Off Indicators Note that during monitoring prior and post recording ECG frequency response filters will be 0.5 Hz 175 Hz. Patient leads are isolated from system and operator, with 5kV protection Protected 95 dB Connection status for each lead is shown on acquisition screen Permanent filters during recordings High Pass: 0.05 Hz 1st order Low Pass: 175 Hz 1st order Note that during monitoring prior and post recording ECG frequency response filters will be 0.5 Hz 175 Hz. Baseline Wander: Baseline reset by adaptive zeroing algorithm Notch filter (Mains Noise Rejection) 50 Hz 4th order Butterworth, 49.1Hz - 50.9 Hz, 60 Hz 4th order Butterworth, 59.1 Hz - 60.9 Hz Low pass (Muscle Artifact Filter) 35 Hz 4th order 14.1.3 Impedance pneumography (respiration) Range:

Accuracy Excitation current Excitation frequency 30-150 rpm 2 rpm or 2% whichever is greater

<20 A 56 kHz Measurement Leads available Lead I & Lead II Tempus Pro User/Operator Manual - 41-2001EN-00 Page 233 Chapter 14 Specifications and standards 14.1.4 ETCO2 sensor The Capnometer is automatically compensated for local atmospheric pressure. CO2 Units EtCO2 Range CO2 Waveform Resolution EtCO2, Resolution CO2 Accuracy mmHg or kPa 0-150 mmHg 0.1 mmHg 1 mmHg 0-38 mmHg: 2 mmHg 39-150 mmHg: (5% of reading + 0.08% for every 1 mmHg above 38 mmHg) Note For operation above 35C, add an additional 1 mmHg or 2% (whichever is greater). Respiration Rate Range 0-149 bpm Respiration Rate Accuracy 0-70 bpm: 1 bpm 71-120 bpm: 2 bpm 121-149 bpm: 3 bpm Flow Rate 50 (42.5 flow 65) ml/min, flow measured by volume Waveform Sampling 20 samples/s Response Time (warmed up) 7 s (typical) for ETCO2, <13 seconds for respiration

(assuming a breath rate of 15 rpm) Calibration Interval Annual performance verification may be performed if required and calibration then performed if the system requires. Calibration required after 4000 hours usage of the Capnometer. 14.1.5 Non-invasive blood pressure Range:

Accuracy:

Resolution:

Pulse rate range:

Maximum inflation:

Adult Systolic 40 - 260 mmHg Paediatric Systolic 40-230 mmHg Neonate Systolic 40-130 mmHg Adult Diastolic 20 - 200 mmHg Paediatric Diastolic 20-160 mmHg Neonate Diastolic 20-100 mmHg Adult MAP 26 - 220 mmHg Paediatric MAP 26-183 mmHg Neonate MAP 26-110 mmHg 3 mmHg 1 mmHg 30-220 bpm 2% or 3 bpm (whichever is greater) 300 mmHg (150 mmHg neonate) Tempus Pro User/Operator Manual - 41-2001EN-00 Page 234 14.1 Specifications Initial inflation pressure:

160 mmHg adult, 140 mmHg paediatric, 90 mmHg neonate Method:

14.1.6 Invasive pressure Oscillometric, diastolic values correspond to Phase 5 Korotkoff sounds Channels Sensitivity Bridge Response Filters Range:

Accuracy:

Resolution:

Warm up time 14.1.7 Masimo pulse oximetry Technology Pulse Range Pulse accuracy Pulse resolution Pulse averaging SpO2 Range SpO2 accuracy SpO2 resolution Data update rate Type Wavelength range Perfusion Index range Response Signal strength range Plethysmogram Patient population up to 4 (2 as standard) 5 V/V/mmHg 180 minimum 0-20 Hz (-3 dB) 50-60 Hz notch

-99 310 mmHg 2% or 2 digits including RDTs adaptor cable but excluding the transducer 1 mmHg 10 seconds Masimo SET for use in motion and low-perfusion applications 25-239 bpm Accuracy (all ages): no motion 3 digits, motion 5 digits 1 bpm 8 seconds (configurable) 1-100%

Accuracy (adults/child): no motion or low perfusion 2 digits 70-100%, motion 3 digits 70-100%

Accuracy (neonate): motion, no motion and low perfusion 3 digits 70-100%

1%

3 seconds Functional saturation (test methods available upon request) Red 660 nm, infra-red 905 nm 0.02-20%

<1 second delay 0-7 bars 1 100, auto-gain Reusable soft walled probe for use in clinical and pre-

hospital applications, on fingers and toes for children/adults over 8 years old (other probe types are available from Masimo) Tempus Pro User/Operator Manual - 41-2001EN-00 Page 235 Chapter 14 Specifications and standards SpO2 was determined by testing on healthy adult volunteers in the range 60%-100% SpO2 against a laboratory CO-Oximeter. SpO2 accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135 days old and weighting between 0.5 and 4.25 kg. Seventy-nine (79) data samples were collected over a range of 70 - 100% SaO2 with a resultant accuracy of 2.9% SpO2. The arterial oxygen saturation accuracy during no motion only applies to LNOP Blue SpO2 adhesive sensors. Masimo SET technology with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-

repetitive motion between 1 to 4Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The saturation accuracy of the neonatal sensors was validated on adult male and female volunteers with light to dark skin pigmentation and 1% was added to account for the properties of foetal haemoglobin. The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimos simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population. Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 236 14.1 Specifications 14.1.8 Masimo Set rainbow Carboxyhemoglobin (SpCO) Measurement Range:

0 99%

Accuracy (Adults/Paediatrics/Infants):

1 40% 3%

Resolution:

Alarm:

1%

1-98%

Methaemoglobin saturation (SpMet) Measurement Range:

Accuracy

(Adults/Paediatrics/Infants/Neonates):

Resolution:

Alarm:

0 99.9%

1 15% 1%

0.1%

1-99.5%

Total haemoglobin concentration (SpHb) Measurement Range:

0 25 g/dL Accuracy (Adults/Paediatrics):

8 17 g/dL 1 g/dL (arterial or venous) Resolution:

Alarm:

0.1 g/dL 1-24.5 g/dL Total oxygen content (SpOC) Measurement Range:

0 35ml of O2/dL of blood SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in the range of 60% - 100% SpO2, O% - 40% SpCO, and 0% - 15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over a range of 70-100%

SaO2 and 0.5-2.5% MetHb with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet. The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory Co-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimos simulator with signal strengths of greater than 0.2% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion. The following substances may interfere with pulse CO-Oximetry measurements:

Elevated levels of Methaemoglobin (MetHb) may lead to inaccurate SpO2 and SpCO measurements Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements Severe anaemia may cause erroneous SpO2 readings Tempus Pro User/Operator Manual - 41-2001EN-00 Page 237 Chapter 14 Specifications and standards Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. Elevated levels of total bilirubin may lead to inaccurate SpO2, SpMet, SpCO and SpHb readings. 14.1.9 Contact temperature Channels Compatibility:

Measurement range:

Accuracy:

Resolution:

Measurement time 2 (first standard, second is optional) YSI series 400 20-45 C / 68-113 F 0.1 C / 0.2 F 0.1 C / 0.2 F

<10 seconds Tempus Pro User/Operator Manual - 41-2001EN-00 Page 238 14.2 Physical characteristics and environmental specifications 14.2 Physical characteristics and environmental specifications Size and weight non-printer model:

Standalone size and weight of Tempus Pro part number 00-1004-R with its battery and RapidPak clip but without external cables, sensors or accessories:

Size and weight printer model:

263 mm (10.3) x 216 mm (8.5) high x 100 mm (3.9)

(width x height x depth) 2.9 kg (6.4 Ib) nominal The non-printer model with a Bluetooth headset is slightly heavier (part number 00-1007-R). Standalone size and weight of Tempus Pro part number 00-1026-R with its battery and printer but without external cables, sensors or accessories:

263 mm (10.3 ) x 216 mm (8.5 ) x 102 mm (4 )

(width x height x depth) 3.2 kg (7 Ib) nominal Printer models without invasive pressure are slightly lighter

(part number 00-1024-R). Altitude:

-200 to 5486 m (-656 to 18000 ft)

(can be used at higher physical altitudes provided the local atmosphere is no higher than 5486 m, e.g. in a pressurised aircraft cabin) Note The power supplys altitude rating must be adhered to. Do not use the power supply outside of its specifications. Relative humidity:

15%-95% (non-condensing) Operating temperature range:

0 C to 50 C all functions, 0 C to 40 C charging Short term operating low -20 C for 60 mins after being stored at room temperature Transport/Storage temperature range:

-37 C to +73.3 C Transport/Storage pressure range:

-200 to 5486 m (-656 to 18000 ft) Start-up time in normal use Start-up time from storage 104 kPa to 53 kPa Time for switching on or starting until the equipment is ready for normal use: 42 seconds Time required for the equipment to warm from the minimum storage temperature between uses until the equipment is ready for intended use at 20C: 180 minutes Time required for the equipment to cool from the maximum storage temperature between uses until the equipment is ready for its intended use at 20C: 180 minutes IP66 (dust and water ingress under pressure) whole device. According to IEC60529, IP means ingress protection. The following two numerals refer to grades of ingress protection for solid objects (the first numeral) and water (the second numeral). The first numeral 6 means the device is dust-proof against the ingress of dust to a size <75 m. The second numeral means the device is protected against the ingress of 100 l/m of water jetting at the device from 2.5 to 3 m. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 239 Chapter 14 Specifications and standards 14.2.1 Environmental performance and certification Drop Transit Drop Operational Drop Impact 1 m drop per IEC60601-1 1.22 m (4 ft) MIL 810G, 26 drops all corners, faces and edges with and without accessories connected 0.75 m (2.5 ft) IEC60068-2-32 Procedure 1, 6 drops to all faces with the device fully operational and all accessories connected 500 g steel ball from 1.3 m as per IEC60601 including the display Temperature & altitude:

Category:

Test Standard, A1 Temperature, RTCA/DO-160E Section 4, Para 4.5.1 to 4.5.4 Test Standard, Altitude, RTCA/DO-160E Section 4, Para 4.6.1 and 4.6.2 Temperature:

Operating: 0 C to +50 C Storage: -37 C to +73.3 C Short Term High: +50 C Rapid Decompression:

2438 m to 5486 m (8,000 ft to 18000 ft) in 15 seconds Temperature variation:

Test Standard:

Rate of Variation:

RTCA/DO-160E Section 5 Cat C 2 C per minute. Humidity:

Test Standard:

Transport/Storage:

Operating:

RTCA/DO-160E Section 6 Cat A 15 to 95% RH Non-condensing (tested for 48 hours at 38-50 C) 15 to 95% RH Non-condensing (tested at the end of the storage cycle) Operational shocks & crash safety:

Test Standard:

Operational Shock:

Crash Safety:

Vibration:

Test Standard:

RTCA/DO-160E Section 7 Cat B Para 7.2 (6g for 11ms saw-tooth wave, repeated 3 times in all axis). 20g in all directions (sustained). Test Standard: MIL-STD-810G rotary, fixed wing (jet and turboprop profile) Explosion proofness:

Not tested. Not to be used in the presence of explosive gasses or vapours. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 240 14.2 Physical characteristics and environmental specifications Water proofness:

Not tested to RTCA/DO-160G Section 10 Commercial qualification:

IP66 (dust ingress under pressure) whole device (excluding internal printer, which is IP43) Fluids susceptibility:

Not applicable. Sand & dust:

Commercial qualification:

Fungus resistance:

Not applicable. Salt spray:

Not applicable. Magnetic effect:

Not applicable. Power input:

Not tested to RTCA/DO-160E Section 16. Commercial qualification:

EN61000-3-2:2006 inc A1/A2:2009 Mains harmonics EN61000-3-3:2008 Mains flicker EN61000-4-11:2004 voltage dips and interruptions Voltage spike:

Not tested to RTCA/DO-160G Section 17. Commercial qualification:

IEC61000-4-4:2012 Fast transient bursts Audio frequency conducted susceptibility power inputs:

Not tested to RTCA/DO-160G Section 18. Commercial qualification:

IEC61000-4-5:2006 Surges Induced signal susceptibility:

Not tested to RTCA/DO-160G Section 19. Commercial qualification:

IEC61000-4-6:2013 Conducted RF field Radio frequency susceptibility (radiated & conducted):

Not tested to RTCA/DO-160G Section 20. Commercial qualification:

IEC61000-4-3:2006 inc A2:2010 Radiated RF Interference Emission of radio frequency energy:

Test Standard:

RTCA/DO-160G Section 21 Cat M. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 241 Chapter 14 Specifications and standards Lightning induced transient susceptibility:

Not applicable. Lightning direct effects:

Not applicable. Icing:

Not applicable. ESD:

Not tested to RTCA/DO-160G Section 25. Commercial qualification:

IEC61000-4-2:2008 ESD Fire and smoke hazards:

Main case material:

Flame:

Overmould material:

PC-ABS UL94V-0 TPU (*)

(*) Contains 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol. 14.2.2 Use in high ambient temperatures CAUTION Since the Tempus is rated for use in high ambient temperatures, users are reminded to give consideration to the potential for outer surfaces of the Tempus to become hot in such ambient temperatures. Further to Table 23 of IEC60601-1:2005, plastic parts (such as the sides, touchscreen, handle etc.) which may be acceptable for long term physical contact at ambient temperatures up to 48C need to be touched for shorter durations (e.g. less than 1 minute) when used in higher ambient temperatures. Similarly, users should note that while the rear heat sink may be touched permanently in ambient temperatures up to 36C, in higher ambient temperatures contact with it should be reduced. Users should pay attention to this if instead of using the handle, they grip the device around its sides. Note Note Note In ambient temperatures above 40 C users should ensure that the device is used in an upright position and that there is air flow around the back of the unit. Users are reminded that the Tempus (when using its external power supply) should not be used to recharge batteries above 40C see 14.2 Physical characteristics and environmental specifications. Users are reminded that the specification of the power supply limits its use to 40C maximum see 14.3 Miscellaneous features and specifications. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 242 14.3 Miscellaneous features and specifications 14.3 Miscellaneous features and specifications 14.3.1 Invasive pressure USB module 01-2017 (optional) Channels Sensitivity Bridge Response Filters Range:

Accuracy:

Resolution:

Warm up time Ingress protection Size Weight EMC Altitude:

2 5 V/V/mmHg 180 minimum 0-20 Hz (-3 dB) 50/100/150 Hz & 50-60 Hz notch

-99 310 mmHg 2% or 2 digits including RDTs adaptor cable but excluding the transducer 1 mmHg 10 seconds IP56 108 mm x 63 mm x 36 mm 116g IEC 60601-1-2:2014 Class B

-200 to 5486 m (-656 to 18000 ft)

(can be used at higher physical altitudes provided the local atmosphere is no higher than 5486 m, e.g. in a pressurised aircraft cabin) Relative humidity:

15%-95% (non-condensing) Operating temperature range:

0 C to 40 C due to transducer specifications Transport/Storage temperature range:

-37 C to +73.3 C Transport/Storage pressure range:

-200 to 5486 m (-656 to 18000 ft); 104 kPa to 53 kPa Drop Transit Drop 1 m drop per IEC60601-1 1.22 m (4 ft) MIL 810G, 26 drops all corners, faces and edges with and without accessories connected (when not connected to the Tempus Pro) Impact 500 g steel ball from 1.3 m as per IEC60601 Emission of radio Frequency energy:

Temperature & Altitude:

Category:

Test Standard, Temperature, RTCA/DO-160G Section 21 Cat M. A1 RTCA/DO-160E Section 4, Para 4.5.1 to 4.5.4 Test Standard, Altitude, RTCA/DO-160E Section 4, Para 4.6.1 and 4.6.2 Temperature:

Operating: 0 C to +40 C Storage: -37 C to +73.3 C Rapid Decompression:

2438 m to 15545 m (8,000 ft to 51,000 ft) in 1 second Tempus Pro User/Operator Manual - 41-2001EN-00 Page 243 Chapter 14 Specifications and standards Temperature Variation:

Test Standard:

Rate of Variation:

Humidity:

Test Standard:

Transport/Storage:

Operating:

RTCA/DO-160E Section 5 Cat C 2 C per minute. RTCA/DO-160E Section 6 Cat A 15 to 95% RH Non-condensing (tested for 48 hours at 38-50 C) 15 to 95% RH Non-condensing (tested at the end of the storage cycle) Operational Shocks & Crash Safety:

Test Standard:

RTCA/DO-160E Section 7 Cat B Operational Shock:

Crash Safety:

Vibration:

Test Standard:

Main case material:

Flame:

14.3.2 Rechargeable battery Battery life Nominal voltage Charging voltage Nominal capacity Weight Dimensions Shelf life Para 7.2 (6g for 11ms saw-tooth wave, repeated 3 times in all axis). 20g in all directions (sustained). MIL-810-F rotary, fixed wing (jet and turboprop profile) PC-ABS UL94V-0 At least 10 hours with display brightness at 60% (default), ECG, SpO2, ETCO2, IP x 2, temp x 2 and NIBP every 15 minutes. At least 11 hours with display brightness at 30%, ECG, SpO2, ETCO2, IP x 2, temp x 2 and NIBP every 15 minutes. Up to 14 hours with battery saving mode activated (display at default 60% brightness) typically 12 hours with the display active 50% of the time. 7.4 V 8.4 V 1%

10.2 Ah, 75.5 Wh 0.42 kg nominal 152 x 42 x 62 mm max Approximately 75% remaining after 1 year (before the charge indicator light turns to Amber) Operating temperature

-20C to +60C Note Battery shelf life and run times are based on a new, fully charged battery stored and used at 20 C. Run time is based on RDTs model of typical device usage in an incident. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 244 14.3 Miscellaneous features and specifications 14.3.3 Mains power supply Note Only the RDT mains power supply (part number 01-2049) can be used with the Tempus Pro. Mains input voltage Frequency Input current Output voltage Output current 100 240 V 50/60 Hz & 400 Hz

~2 A (<0.5 A drawn when supplying the Tempus) 12 V dc 5 A Relative humidity:

15%-95% (non-condensing) Weight Dimensions 0.42 kg nominal 133 x 60.7 x 41 mm (5.24 x 2.39 x 1.62) Operating temperature range:

0 C to 50 C Transport/Storage temperature range:

Altitude:

-40 C to +85 C 0 4000 m (0 13,123 ft) Note The power supplys altitude rating of 4000m must be adhered to. Do not use the power supply outside of its specifications. 14.3.4 Battery charger Note Only the RDT Battery Charger (part number 01-1012) can be used with the Tempus Pro. Mains input voltage Frequency Input current Output voltage Output current Charge time (from empty) Weight Dimensions 100-240 V 50-60 Hz 0.9 A max (at 100 V approx.) 8.4 V dc

<2.73 A 6 hours 0.25 kg nominal 107 x 67 x 36.5 mm Tempus Pro User/Operator Manual - 41-2001EN-00 Page 245 Chapter 14 Specifications and standards 14.3.5 Vehicle power supply Battery input voltage Input connector type Output voltage Output current max Rated Power Efficiency 11V dc 27 Vdc Cigar plug 12 Vdc 5%

6 A 72 W

>85%

Operating temperature range:

0 C to 40 C Transport/Storage temperature range:

-20 C to +85 C Weight Dimensions Operational shock Non-operational shock 14.3.6 GPS Antenna Accuracy 14.3.7 Other features Display Printer (*) 0.21 kg nominal 105 x 40 x 26.5 mm 10g 60g Integral 10 m (2.5 km with <6 satellites labelled as Approximate Fix) Colour 165 mm (6.5) 640x480 pixels 130 klux daylight readable display High resolution 113 mm (4) integrated thermal printer Integral digital camera Color 3.2M pixel camera Takes still pictures or video using the H264 algorithm

(bandwidth dependent)

(*) Optional, additional feature Tempus Pro User/Operator Manual - 41-2001EN-00 Page 246 14.4 Communications 14.4 Communications 14.4.1 i2i ReachBak communications When connecting to a Response Centre via i2i ReachBak, the Tempus has the following communications requirements:

Tempus Connection all data AES encrypted: Ethernet; WiFi WEP, WPA, WPA-2; Cell 3G. Database all PHI AES 256 encrypted. Tempus to Destination Data Centre

(Gateway) Medical Data (1) Port Minimum data rate

(FIPS 140-2 enabled) required TCP 2169 3 kbps 3 kbps Waveforms

(2) UDP (SRTP) port 52508 Voice

(VOIP) (3) UDP (SRTP) 52505 Video (4) UDP (SRTP) port 52506 6 kbps 12 kbps 12 kbps 40 kbps Total (5) 21 kbps 55 kbps Response Centre to Data Centre

(Gateway) Destination Port

(FIPS 140-2 enabled) Minimum data rate required Medical Data (1) TCP 52169 3 kbps 3 kbps Waveforms

(2) UDP (SRTP) port 52509 Voice

(VOIP) (3) UDP (SRTP) 52511 Video (4) UDP (SRTP) port 52507 6 kbps 12 kbps 12 kbps 40 kbps Total (5) 21 kbps 55 kbps Notes:

(1) Medical Data means heart rate, non-invasive blood pressure, SpO2, ETCO2, invasive pressure, respiration rate and temperature with still photos and 12 Lead ECG recordings transmitted on a store-

and-forward basis and TCCC card data sent every 30 seconds.

(2) Waveforms means 1-2 channels of ECG, Plethysmogram and Capnogram and 1-2 channels of invasive pressure.

(3) VOIP - Speex codec .

(4) Video - H264 format CIF image transmitted at 5 frames per second - this provides a low-bandwidth video solution.

(5) Total rate is on a lossless data transfer; the bandwidth is likely to increase if data retry attempts are required due to packet loss on the network. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 247 Chapter 14 Specifications and standards

(6) The Data Centre application is installed on the first or primary PC to use the i2i application. The Data Centre application is simply installed (selected) during the i2i installation process. Ports will need to be opened on firewalls in and out of the DC and RC.

(7) A shared database is recommended between all RC installations. This requires a local wired network.

(8) Web access is optional and allows users with i2i installed on a PC (with internet access) to share the data elements of the real time display with other users via the web who don't have i2i. Web access is automatically terminated when the Tempus disconnects from the i2i. I2i transmission rates ECG data and digital pictures take an appreciable amount of time to send to the Response Centre, approximate times are as follows:

12 lead ECG < 30 seconds Digital photographs < 30 seconds These times are for guidance only and are based on a typical Ethernet network. Times may vary depending on network equipment, configuration and usage. IEEE 802.3 compliant 14.4.2 Ethernet specification The Ethernet connection has the following specifications:

RJ-45 connection DHCP or fixed IP, Mask, Gateway Network cable: CAT5 at least 50 m 14.4.3 WiFi specification The WiFi technology used by the Tempus operates using IEEE 802.11b and 802.11g standard. It operates in the Industrial, Scientific and Medical (ISM) band between 2.412 GHz and 2.484 GHz. WARNING Per IEC60601-1-2 cl 5.2.2.5 b), the Tempus may be interfered with by other systems even if they comply with CISPR emissions. The WiFi technology has the following features:

WiFi Specification The WiFi module has the following specifications:

Range Data Rate:

Security

~ 91 m (300 ft) CCK: 1, 2, 5.5, 11 Mb/s OFDM 6, 9, 12, 18, 24, 36, 48, 54 MB/s WEP, TKIP, WPA and WPA2 AES/CCMP per IEEE 802.11 i Baseband Modulation Quality of Service 802.11g: OFDM 802.11b: DSSS/CCK 802.11 e EDCF Tempus Pro User/Operator Manual - 41-2001EN-00 Page 248 14.4.4 Integral 2G and 3G cell phone specification The Cell Phone (GSM) technology used by the Tempus has the following specifications:

Operating frequency range:

14.4 Communications Parameter Frequency Range Uplink (MS BTS) Min Max Unit GSM 850 824 849 MHz E-GSM 900 880 915 MHz GSM 1800 1710 1785 MHz GSM 1900 1850 1920 MHz UMTS 850 824 849 MHz UMTS 900 880 915 MHz UMTS 1900 1850 1910 MHz UMTS 2100 1920 1980 MHz Frequency Range GSM 850 869 894 MHz Downlink (BTS MS) E-GSM 900 925 960 MHz GSM 1800 1805 1880 MHz GSM 1900 1930 1990 MHz UMTS 850 869 894 MHz UMTS 900 925 960 MHz UMTS 1900 1930 1990 MHz UMTS 2100 2110 2170 MHz RF power:

Band GSM/GPRS 850/900 GSM/GPRS 1800/1900 EDGE 850/900 EDGE 1800/1900 UMTS 850/900/1900/2100 Max Unit 33 30 27 26 24 dBm dBm dBm dBm dBm Note This device contains GSM 900 MHz and GSM 1800MHz functions that are not operational in U.S. Territories. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 249 Chapter 14 Specifications and standards 14.4.5 Bluetooth specification WARNING Per IEC60601-1-2 cl 5.2.2.5 b), the Tempus may be interfered with by other systems even if they comply with CISPR emissions. The Bluetooth module has the following specifications:

Indoor Range Data Rate:

Baseband Modulation

~ 9 m (30 ft) (typical office environment) V2.0 up to 1 Mb/s EDR: 2.3 Mb/s V2.0: GFSK EDR: Pi/4 DQPSK, 8DPSK 14.4.6 Bluetooth headset specification The Tempus Pro uses the Sennheiser Presence or VMX200 wireless headset. This is unmodified by RDT and is provided under FCC part 15C and an Industry Canada License 2099D. Users are reminded to refer to the Sennheiser user guide (attached to the CD-ROM provided with the Tempus) that provides instructions for use of the headset. These include environmental performance specifications which may differ from those of the Tempus. Description Bluetooth type Range General Specifications V4.0 class 1 (Presence) V3.0 class 2 (VMX200) 10 m max in an open field Transmission frequency 2402 2480 MHz Bluetooth Profiles Weight Size Talk time HSP, HFP, A2DP (Presence) HSP, HFP (VMX200) 13 g (Presence) 10 g (VMX200) 51 x 19 x 23 mm (Presence) 55 x 26 x 58 mm (VMX200)

(WxHxD) Up to 4 hours* (Presence) Up to 6 hours* (VMX200) Stand by time Up to 240 hours*

Operating temperature range 10 40 C Operating humidity range 20 85% non-condensing Storage temperature range

-20 to +60 C Storage humidity range 10-95% non-condensing

*Battery shelf life and run times are based on a new, fully charged battery. 14.4.7 Communications security specification The Tempus Pro is (optionally) provided with Mocana Federal Information Processing Standard (FIPS) 140-

2 cryptographic module. This provides US government certified encryption on the voice, data and video transmission. The FIPS 140-2 encryption provided on the Tempus Pro is Level 1 as specified by the FIPS 140-2 standard. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 250 14.4 Communications 14.4.8 FCC and Industry Canada compliance CAUTION Do not disassemble the device. There are no user-serviceable parts inside. Refer servicing to the manufacturer. Changes or modifications not expressly approved by RDT could void the users authority to operate the equipment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Increase the separation between the equipment and receiver. The user may find the following booklet helpful: How to Identify and Resolve Radio-TV Interference Problems. This booklet is available from U.S. Government Printing Office, Washington, D.C. 20402. This equipment is also ETS 300 328, ETS 300 826, ETS 300 328-2, ETS EN301 489-1 and ETS EN301 489-17 compliant. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. FCC compliance This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions:

This device may not cause interference and This device must accept any interference, including interference that may cause undesired operation of the device. IC complance This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Industry Canada Standard ICES-003. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:

1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 251 Chapter 14 Specifications and standards 14.5 Tempus Pro device classification The system is classified according to the requirements of EN60601-1:2006, the standard for Medical Electrical Equipment, Part 1, General Requirements for Safety, as:

The Tempus Pro is internally (battery) powered. The external power supply is class I (earthed) as defined by the classification of the power supply specified and supplied by RDT. The battery charger is class II (double insulated). Applied parts type CF defibrillator proof. All patient coupled connections from the Tempus are designated as Patient Applied Parts per IEC60601-1. The Tempus Pro is rated IP66, protected against rainfall according to IEC60529. This means that the device is proof against the ingress of talcum powder into the body of the device (into its case) and also proof against the entry of water from a strong hose (akin to a garden hose) into the body of the device

(into its case). All other parts are rated IPXX. The device is rated IP66 with all connectors either mated or unmated (except the Capnometer cannula which must be unconnected and its door clicked shut) and with dust covers fitted or not fitted and with the battery mated or unmated. No parts supplied sterile or suitable for/requiring sterilising. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Suitable for continuous use, for use with defibrillators and for use with electrosurgical systems. The expected service life of the device (excluding batteries) is 5 years. This can be extended through maintenance of the device. 14.5.1 Standards compliance The Tempus Pro complies with the applicable parts of the following standards:

Standard Title IEC 60601-1 3rd edition Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2 4th edition Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -

Requirements and tests IEC 60601-1-6 EN 60601-1-8 IEC 60601-2-49 ISO 80601-2-56 EN 60601-2-34 Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability Medical electrical equipment -- Part 1-8: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Medical electrical equipment -- Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment Tempus Pro User/Operator Manual - 41-2001EN-00 Page 252 14.6 EMC information Title Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Medical device software -- Software life cycle processes Medical devices -- Part 1: Application of usability engineering to medical devices Standard EN 60601-2-37 IEC 60601-2-25 IEC 60601-2-27 EN 80601-2-61 EN 80601-2-55 EN 62304 EN 62366 14.6 EMC information The following tables provide information required to be provided under IEC60601-1-2. 14.6.1 Cable length of the sensors and the accessories Ethernet cable SpO2 sensor 3-lead ECG cable 4-lead ECG cable 5-lead ECG cable RDT Part Number 01-2025 01-2014 Various Various Various 12-lead ECG cable Various IBP adaptor cable Various Wired headset 01-1019 Mains Power supply 01-2049 Mains lead 01-2055 Cable Length

(typ.) 2.1m 2.4m 2.4m 2.4m 2.4m 2.4m 2.4m 1.2m 0.45m 2m Tested Length 2.1m 2.4m 2.4m 2.4m 2.4m 2.4m 2.4m 1.2m 0.45m 2m WARNING The use of longer cable lengths may cause an increased emission or a reduced interference resistance. The use of other sensors or cables except the ones mentioned above is not allowed. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 253 Chapter 14 Specifications and standards CAUTION For the purposes of compliance with IEC60601-1-2, all vital signs and communications functions were regarded as essential performance. 14.6.2 Manufacturer's Declarations Electromagnetic Emissions (IEC EN 60601-1-2) The Tempus Pro is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment. Emission Measurements Compliance Electromagnetic Environment HF emissions acc. to CISPR11 Group 2 The Tempus Pro must emit RF energy in order to perform its function. Nearby electronic devices may be affected. HF emissions acc. to CISPR11 Class B Note that the Tempus Pro can be configured for not to emit RF energy in which case it will be group 1 and will not be likely to cause any interference in nearby electronic equipment. The Tempus Pro is intended for use in all facilities including living quarters and such ones which are connected directly to a public power supply that supplies also buildings used for living purposes. Emission of overtones acc. to IEC61000-3-2 Class B Emission of voltage fluctuation/flicker acc. to IEC61000-3-3 Complies Electromagnetic Emissions (IEC EN 60601-1-2) The Tempus Pro is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment. Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment

- Guidelines Electrostatic discharge (ESD) acc. to IEC 61000-4-2 8 kV contact discharge 15 kV air discharge 8 kV contact discharge 15 kV air discharge Floors should be of wood, concrete or ceramic tiles. If the floor is tiled with synthetic material the relative air humidity must have 30 % at least. Fast transient electric disturbances / bursts acc. to IEC 61000-4-

4 2 kV for power lines 1 kV for input and output lines 2 kV for power lines 1 kV for input and output lines The quality of the supply voltage should conform to a typical business or clinic environment. Surge voltage acc. to IEC 6100-4-5 1 kV normal mode voltage 2 kV common mode voltage 1 kV normal mode voltage 2 kV common mode voltage Mains power should be that of a typical hospital or commercial environment. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 254 14.6 EMC information Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment

- Guidelines Voltage drops, short interruptions and variations in supply voltage acc. to IEC 61000-4-11

< 5 % UT (>95 %

break of UT) for 0.5 period

< 5 % UT (>95 %

break of UT) for 0.5 period 40 % UT (60% break of UT) for 5 periods 40 % UT (60% break of UT) for 5 periods 70 % UT (30% break of UT) for 25 periods 70 % UT (30% break of UT) for 25 periods Mains power should be that of a typical hospital or commercial environment. If the user of the Tempus Pro requires continued operation during power interruptions, then the battery may be used for periods up to 6 hours or a UPS may be used.

< 5 % UT (>95 %

break of UT) for 5 seconds

< 5 % UT (>95 %

break of UT) for 5 seconds 30 A/m 100 A/m Magnetic field at the supply frequency

(50/60 Hz) acc. to IEC 61000-4-8 NOTE UT is the AC mains voltage before the use of testing levels Magnetic fields at the supply frequency should conform to the typical values as they occur in the business or clinic environment. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 255 Chapter 14 Specifications and standards Electromagnetic Interference Resistance (IEC EN 60601-1-2) The Tempus Pro is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment. Interference Resistance Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines Portable and mobile RF communications equipment should be used no closer to the device including the cables than it is recommended by the equation for the frequency. Recommended safety distance Conducted RF disturbances acc. to IEC61000-4-6 3 Vrms 150 kHz to 80 Mhz 6 Vrms in ISM bands

(*1) Radiated RF disturbances acc. to IEC61000-4-3 3 V/m 80 MHz to 2.7 GHz Frequency spots as listed below

(*4) 3 Vrms d = 1.2P 6 Vrms d = 1.2P 3 V/m for all parameters &

20 V/m for all parameters except invasive pressure per EN 1789 Frequency spots as listed below

(*4) d = 1.2P for 80 MHz to 800 MHz d = 2.3P for 800 MHz to 2.7 GHz P is the nominal power of the transmitter in watt (W) according to the specifications of the transmitter manufacturer; d is the recommended safety distance in meters (m). The field strength of stationary transmitters should be lower than the Compliance level for all frequencies according to a testing on location (*2) (*3). Interference may occur in the vicinity of devices with the following symbol:

NOTE 1: For 80 Hz and 800 MHz the higher frequency range applies. NOTE 2: These guidelines may not be applicable for all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects and people.

(*1) The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

(*2) The field strength of stationary transmitters such as fixed parts of cellular phones and mobile radio sets, amateur radio stations, AM and FM radio and television cannot be determined exactly in theory. To detect the electromagnetic environment in regard to stationary transmitters a study of the location should be considered. If the measured field strength at the location where the device is being used exceeds the Compliance level above the device should be watched to verify the proper functions. If unusual features are watched additional actions might be necessary such as a modified orientation or another location of the device.

(*3) For the frequency range of 150 kHz to 80 MHz, the field strength should be lower than 10 V/m.

(*4) Immunity to proximity fields from RF wireless communications equipment:

Tempus Pro User/Operator Manual - 41-2001EN-00 Page 256 Test frequency

(MHz) Service 385 TETRA 400 450 GMRS 460, FR 460 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800; CDMA 1900; GSM 1900; DECT;

LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 WLAN 802.11 a/n Modulation Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 14.6 EMC information Immunity test level

(V/m) 27 28 9 28 28 28 9 Tempus Pro User/Operator Manual - 41-2001EN-00 Page 257 Chapter 14 Specifications and standards 14.6.3 Recommended safety distances Recommended Safety Distances between portable and mobile RF Telecommunication Devices and the Tempus Pro (Tab. 206 according to IEC EN 60601-1-2). The TEMPUS PRO is intended for use in an electromagnetic environment with controlled RF disturbances. The user of the device can help to avoid electromagnetic disturbances by keeping the minimum distance between portable and mobile telecommunication devices (transmitters) and the device - depending on the output power of the telecommunication devices as described below. Safety Distance Depending on the Frequency in m Nominal power of the transmitter (W) 150 kHz to 80 MHz d = 1.2P 80 MHz to 800 MHz d = 1.2P 800 MHz to 2.7 GHz d = 2.3P 0,01 0,1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters with a maximum nominal power not mentioned above: To detect the recommended safety distance use the equitation in the corresponding column. P is the maximum nominal power of the transmitter in watt (W) according to the specifications of the transmitter manufacturer. NOTE 1: For 80 Hz and 800 MHz the higher frequency range applies. NOTE 2: These guidelines may not be applicable for all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects and people. 14.7 Factory default settings Setting Range Factory Default Communications mode Various customer specific Uppermost listed mode within the customer specific communications mode menu Patient NIBP mode Neonate, Child, Adult Manual, Auto, Rapid Cuff Adult Auto NIBP automatic measurement interval 2, 3, 5, 10, 15, 30 and 60 minutes Automatic - 3 minutes QRS volume 0-100% in steps of 20 ECG waveform 1 Lead I-III 3-lead ECG cable 0%

Lead II Lead I-III, aVL, aVR & aVF 4-lead ECG cable Lead I-III, aVL, aVR, aVF & V 5-lead ECG cable Lead I-III, aVL, aVR, aVF, V1-6 12-lead ECG cable Tempus Pro User/Operator Manual - 41-2001EN-00 Page 258 14.7 Factory default settings Setting Range ECG waveform 2 Lead I-III, aVL, aVR & aVF 4-lead ECG cable Lead I-III, aVL, aVR, aVF & V 5-lead ECG cable Lead I-III, aVL, aVR, aVF, V1-6 12-lead ECG cable Factory Default Lead I ECG wave speed 12.5, 25, 50 mm/s 25mm/s ECG Gain 2, 4, 5, 10, 15, 20, 30 and 50 mm/mV 10mm/mV ECG Monitoring filter Monitor (0.5 Hz 35 Hz) Filtered diagnostic (0.05 Hz 35 Hz) Diagnostic (0.05 Hz 150 Hz) Monitor (0.5 Hz 35 Hz) ECG Mains filter ON-OFF Arrhythmia detection ON-OFF Mains frequency 50-60 Hz ON ON 50Hz (this value is retained and not reset after 8 hours or for a new patient) Pulse Oximeter plethysmogram wave speed Capnograph wave speed 12.5, 25, 50 mm/s 25mm/s 3.1, 6.25, 12.5 mm/s 6.25mm/s Temperature readings C - F C Invasive pressure See 6.6.4 Configuring the transducer

/ channel. P1 White with arterial settings P2 White with arterial settings P3 White with arterial settings P4 White with arterial settings Tempus Pro User/Operator Manual - 41-2001EN-00 Page 259 15 Symbols used on the Tempus Pro 15.1 Symbols used The following symbols are used on the Tempus Pro:

Symbol Description Symbol for pausing audible alarms temporarily Symbol for pausing all alarm manifestations (visual and audible) temporarily Alarm off (either individual parameter or all parameters) General alarm symbol Defibrillation proof type CF applied part, Capnometer inlet ECG Socket Tempus Pro User/Operator Manual - 41-2001EN-00 Page 260 Symbol Description 15.1 Symbols used Pulse oximeter socket Contact temperature sockets NIBP socket Attention, consult accompanying documents Attention, consult accompanying documents Tactical Mode Not for use with YSI 700 series sensors Battery Charge indicator flashes green when the battery is on charge Battery power level Tempus Pro User/Operator Manual - 41-2001EN-00 Page 261 Chapter 15 Symbols used on the Tempus Pro Symbol Description System power on/off (push/push) Date of manufacture, where the year that the item was manufactured is represented by the year and then the month e.g. 2002 06 is June 2002. YYYY - MM Single use device only, discard item after use Capnometer Cannula inlet connection These symbols are used to check that the blood pressure cuff is the correct size, once wrapped around the arm the INDEX mark should be between the RANGE marks Centre point of blood pressure cuff bladder - to be aligned with the patients artery Diameter size for the blood pressure cuff Item does not contain any latex (blood pressure cuffs) Item does not contain any PVC (blood pressure cuffs) Tempus Pro User/Operator Manual - 41-2001EN-00 Page 262 Symbol Description 15.1 Symbols used IP66 (dust and water ingress under pressure) whole device. According to IEC60529, IP means ingress protection. The following two numerals refer to grades of ingress protection for solid objects (the first numeral) and water (the second numeral). The first numeral 65 means the device is dust-proof against the ingress of dust to a size

<75 m. The second numeral means the device is protected against the ingress of 100 l/m of water jetting at the device from 2.5 to 3 m. The device has been declared by the manufacturer to be in accordance with the requirements of the European Union Medical Devices Directive 93/42/EEC (as amended) as transposed by UK national legislation. For class IIa and IIb devices. The device has been declared by the manufacturer to be in accordance with the requirements of the European Union Medical Devices Directive 93/42/EEC as transposed by UK national legislation. For class I devices. Shelf life, where the time that the unit must be used by is represented by the year and then the month e.g. 2004 06 is June 2004. IP66 LOT YYYY - MM Where the year that the item was manufactured as a part of a larger batch is represented by the year and then the month e.g. 2002 06 is June 2002. This product should not be discarded as general waste and must be disposed of as electrical and electronic waste. Communications connections WiFi connection mode to Response Centre Tempus Pro User/Operator Manual - 41-2001EN-00 Page 263 Chapter 15 Symbols used on the Tempus Pro Symbol Description Bluetooth connection to medical modules Battery Connection to indicate positive terminal polarity Global Positioning System (GPS) Global System for Mobile (GSM) communications Headset connector Ethernet Socket (RJ-45) USB 2.0 & 1.0 sockets Power Status (green indicates mains power is connected) Tempus Pro User/Operator Manual - 41-2001EN-00 Page 264 15.1 Symbols used Symbol Description Camera Backlight Device contains wireless transmitters DC connector Packing box to be stored upright Packing box contains breakable items handle with care Recyclable packaging Packaging should not be discarded Tempus Pro User/Operator Manual - 41-2001EN-00 Page 265 Chapter 15 Symbols used on the Tempus Pro Symbol Description Packing box should not be exposed to rain/water/moisture Packing box storage humidity range Packing box storage temperature range Packing box storage pressure/altitude range Tempus Pro User/Operator Manual - 41-2001EN-00 Page 266 15.1 Symbols used Tempus Pro User/Operator Manual - 41-2001EN-00 Page 267 16 End user license agreement 16.1 Tempus Pro EULA This license covers RDTs Tempus Pro software. Warning: The software contained herein is protected by copyright law and international treaties. Unauthorized reproduction, distribution or reverse engineering of this program, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. You acknowledge that you will read and adhere to the user manual and ensure that users receive proper training from RDT or an appropriately trained individual. You also acknowledge that you will maintain the software by installing new software updates supplied by RDT within 5 working days of receiving or being notified of them. License:

You may transfer the program and license to another party if the party agrees to accept the terms and conditions of this agreement. You will not share the program with other parties and will keep the program and details of its functions confidential. You will ensure that access to the software and use of it will be restricted to properly trained and authorized personnel only. You will not try to copy or reverse engineer the software. The Tempus Pro operates over third-party communications links, such as telephone lines, GSM or satellite links and the Internet. RDT does not accept liability for the failure of these links to reliably transmit information from RDTs products. Users are reminded that it is their responsibility to ensure that GSM network and other communications contracts are maintained and suitably setup and configured for the areas in which they need to be used. In order to function correctly Tempus Pro needs to operate over a communications link such as satellite communications, GSM or a telephone line and other types of links. It is your responsibility to maintain these communications links. Such links may have security or other measures implemented on them such as firewalls. It is your responsibility to ensure that any such firewalls or other elements of the communication link are configured correctly to allow data from Tempus Pro to communicate over said link. RDT does not accept any responsibility for failure to transmit data or to transmit data reliably over such links if they have not been configured correctly. Support on configuring such links can be obtained from RDT upon request. Neither the Tempus Pro or RDT are a "covered entity" under the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder ("HIPAA"). As a result, HIPAA does not apply to the transmission of health information by RDT or Tempus Pro to any third party. However, users of the Tempus Pro may be covered entities under the HIPAA act and so are reminded that they are responsible for acting accordingly. All users are reminded that it is their responsibility to maintain all patient records in a manner that is compliant with applicable local regulations. The software gives users the ability to share and transmit medical data with third parties. Such activities are entirely the responsibility of the user. RDT owns all proprietary rights to the Tempus Pro. RDT gives you a personal, revocable, non-assignable, and non-exclusive license to use the Tempus Pro. Limited Warranty and Remedies:

In no event shall RDT or its distributors or agents, be liable for any damages resulting from loss of data, loss of revenue or for any incidental or consequential damages incurred arising out of or relating to the use of this Tempus Pro User/Operator Manual - 41-2001EN-00 Page 268 16.2 Mocana EULA software product. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. This warranty gives you specific legal rights and you may have other rights that vary from region to region. RDTs Terms and Conditions apply. RDT and its distributors make no representations with respect to the merchantability or fitness of the Tempus Pro software and the product is supplied "as is", without any warranty of any kind. Further, RDT reserves the right to revise its publications and program(s) without obligation to notify customer of such a revision. You acknowledge that you have read this agreement, understood it, and agree to be bound by its terms and conditions. Failure to enforce any provision will not constitute a waiver of that provision. If any provision is found unenforceable, it and any related provisions will be interpreted to best accomplish the unenforceable provision's essential purpose. This agreement is governed by UK law. The exclusive venue for any dispute relating to this agreement is London UK. You and RDT consent to the personal jurisdiction of these courts. Nothing in this agreement limits either party's ability to seek equitable relief. 16.2 Mocana EULA This license covers the Mocana FIPS 140-2 security technology. CUSTOMER LICENSE AGREEMENT MINIMUM TERMS 1. No Warranty. RDT does not extend to its customers (on Mocanas behalf) any warranty express, implied or statutory including without limitation the implied warranties of title, non-infringement, merchantability, fitness for a particular purpose, accuracy, and quiet enjoyment. 2. No Liability. RDT does not extend to its customers (on Mocanas behalf) any liability, including liability for any incidental, special, consequential, indirect or direct damages of any kind (including damages for interruption of business, procurement of substitute goods, lost data, lost profits, or the like) regardless of the form of action, whether in contract, tort (including negligence), strict product liability, or any other legal or equitable theory. 3. No Reverse Engineering. Users are not permitted to in any way reverse engineer, decompile, or modify the Tempus Pro software, the i2i software or the Mocana software. 4. Export Control. The Tempus Pro (including the Mocana FIPS 140-2 encryption software) contains certain cryptographic functionality, the export and re-export of which is restricted under U.S. law. Note The Mocana FIPS security algorithm is provided as an option only and is not standard on all Tempus Pro devices. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 269 Chapter 16 End user license agreement 16.3 MPEG4 EULA NOTICE REGARDING VIDEO STANDARDS. THIS PRODUCT IS LICENSED UNDER ONE OR MORE VIDEO PATENT PORTFOLIO LICENSES SUCH AS AND WITHOUT LIMITATION VC-1 AND MPEG4 PART2 VISUAL FOR THE PERSONAL AND NON-

COMMERCIAL USE OF A CONSUMER TO:

(i) ENCODE VIDEO IN COMPLIANCE WITH THE STANDARDS LICENSED UNDER SUCH PATENT PORTFOLIO LICENSES AND/OR

(ii) DECODE VIDEO THAT WAS ENCODED BY A CONSUMER ENGAGED IN A PERSONAL AND NON-

COMMERCIAL ACTIVITY AND/OR WAS OBTAINED FROM A VIDEO PROVIDER LICENSED TO PROVIDE VIDEO UNDER SUCH PATENT PORTFOLIO LICENSES. SUCH LICENSE EXTENDS TO THIS PRODUCT ONLY AND ONLY TO THE EXTENT OF OTHER NOTICES WHICH MAY BE INCLUDED IN THIS DOCUMENT. THE LICENSE DOES NOT EXTEND TO ANY OTHER PRODUCT REGARDLESS OF WHETHER SUCH PRODUCT IS INCLUDED WITH THIS LICENSED PRODUCT IN A SINGLE ARTICLE. NO LICENSE IS GRANTED OR SHALL BE IMPLIED FOR ANY OTHER USE. ADDITIONAL INFORMATION MAY BE OBTAINED FROM MPEG LA, L.L.C. SEE HTTP://WWW.MPEGLA.COM. 16.4 Masimo EULA THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE "PURCHASER," AND RDT. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO RDT FOR A FULL REFUND. 1. Grant of License. In consideration of payment of the license fee, which is part of the price paid for this product, RDT grants to Purchaser a nonexclusive, non-transferable license, without right to sublicense, to use the copy of the incorporated software/firmware, and documentation in connection with Purchaser's use of the Masimo Products for their labelled purpose. RDT reserves all rights not expressly granted to Purchaser. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any MASIMO 2. software and/or firmware and the documentation, and all copies thereof, remain at all times vested in MASIMO Corporation, licensor to RDT, and they do not pass to Purchaser. Assignment. Purchaser shall not assign or transfer this License, in whole or in part, by operation of 3. law or otherwise, without RDT's prior written consent; any attempt without such consent, to assign any rights, duties or obligations arising hereunder shall be void. Copy Restrictions. The software/firmware, mask works, circuit board layouts, and accompanying 4. written materials are copyrighted. Unauthorized copying of the software, including software that has been modified, merged, or included with other software, or other written materials is expressly forbidden. You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17 U.S.C. 117. Use Restriction. As the Purchaser, you may physically transfer the products from one location to 5. another provided that the software/firmware is not copied. You may not electronically transfer the software/firmware from the products to any other device. You may not disclose, publish, translate, release distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Masimo Product, the software/firmware, or the written materials without the prior written consent of RDT. Masimo Sensors that are designated for single use are licensed under Masimo patents for use on a single patient only, and are not sold. There is no license, implied or otherwise, that would allow use of single use Masimo Sensors beyond their intended single use. After use of single use Masimo Sensors, there is no further license granted by Masimo to use the sensors and they much be discarded. 6. transferred to anyone, except other end-users, without the prior written consent of RDT. In no event may Transfer Restrictions. The software/firmware is licensed to the Purchaser, and may not be Tempus Pro User/Operator Manual - 41-2001EN-00 Page 270 16.7 OpenSSL License you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis. 7. provisions. Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its U.S. Government Rights: If you are acquiring software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the software is deemed to be

"commercial software" and "commercial computer software documentation," respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this agreement. 16.5 Firebird Interbase Public License The product includes open source code executables without modification. The original code was created by Interbase Software Corp and its successors. Portions created by Borland/Inprise and copyright Borland/Inprise. This software is distributed on an as is basis, without warranty of any kind, either express or implied. The source code of the covered code is available under the terms of its license. 16.6 Info-Zip License Copyright (c) 1990-2007 Info-ZIP. All rights reserved. For the purposes of this copyright and license, "Info-ZIP" is defined as the following set of individuals:

Mark Adler, John Bush, Karl Davis, Harald Denker, Jean-Michel Dubois, Jean-loup Gailly, Hunter Goatley, Ed Gordon, Ian Gorman, Chris Herborth, Dirk Haase, Greg Hartwig, Robert Heath, Jonathan Hudson, Paul Kienitz, David Kirschbaum, Johnny Lee, Onno van der Linden, Igor Mandrichenko, Steve P. Miller, Sergio Monesi, Keith Owens, George Petrov, Greg Roelofs, Kai Uwe Rommel, Steve Salisbury, Dave Smith, Steven M. Schweda, Christian Spieler, Cosmin Truta, Antoine Verheijen, Paul von Behren, Rich Wales, Mike White. This software is provided "as is," without warranty of any kind, express or implied. In no event shall Info-ZIP or its contributors be held liable for any direct, indirect, incidental, special or consequential damages arising out of the use of or inability to use this software. 16.7 OpenSSL License The product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit

(http://www.openssl.org/). Copyright 1998-2011 The OpenSSL Project. All rights reserved. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 271 Chapter 16 End user license agreement 16.8 US Government Devices US Department of Defense (DoD) Notice and Consent Banner The following statement is applicable to devices purchased by US government employees and which are used on SPR networks. You are accessing a U.S. Government (USG) Information System (IS) that is provided for USG-authorized use only. By using this IS (which includes any device attached to this IS), you consent to the following conditions:

1. The USG routinely intercepts and monitors communications on this IS for purposes including, but not limited to, penetration testing, COMSEC monitoring, network operations and defense, personnel misconduct

(PM), law enforcement (LE), and counterintelligence (CI) investigations. 2. At any time, the USG may inspect and seize data stored on this IS. 3. Communications using, or data stored on, this IS are not private, are subject to routine monitoring, interception, and search, and may be disclosed or used for any USG-authorized purpose. 4. This IS includes security measures (e.g., authentication and access controls) to protect USG interests--

not for your personal benefit or privacy. 5. Notwithstanding the above, using this IS does not constitute consent to PM, LE or CI investigative searching or monitoring of the content of privileged communications, or work product, related to personal representation or services by attorneys, psychotherapists, or clergy, and their assistants. Such communications and work product are private and confidential. Tempus Pro User/Operator Manual - 41-2001EN-00 Page 272

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

issanal 12-10-26 | =

TEMPUS@__Patient Monitor eer ae) Eaesierntrirenen enc aS poner Rene OX he ae ie eas}

Contains FCC 1D: PV7-WIBEAR11N-DF2 Contains FCC 1D:NCMOMO6012 Contains IC:7738-WBLINDF2 CAN ICES-3 (B)/NMB-3(8) Contains 1C:27344-MO6012 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. ISSUE REF: 40-2420-00

 

 

Doc ID: UBX-15030249

@b I Ox Authorization Letter Rev.: 2.0 Date: 14/07/2016 Power of Attorney Issued by u-blox AG Zurcherstrasse 68 CH-8800 Thalwil / Switzerland Phone: +41 44722 74 44 Fax: +41 447227447 info@u-blox.com Subject: Authorization letter for FCC/IC signatures To Whom It May Concern:

1am Giulio Comar, Certification Manager and responsible for FCC and IC applications within u-blox.

| hereby authorise the following u-blox employees to sign all application forms, documents and cover letters on my behalf:

e Piero Laudicina e Jake Bascon Olof Viklund e Filip Kruzela Sincerely, Lule Bases Giulio 1, Certification Managet_ oe S.p.A.con socio unico Via Stazione di Prosecco, 15 34010 - Sgonico (Trieste) Italy u-bI alia S.p.A. is a wholly owned subsidiary of u-blox AG Author Giulio Comar Department: cert Page: 1/1 Filename FCC_IC_signature_Authorization_Letter.docx M102 Rev Copyright 2013 u-blox Italia S.p.A. All rights reserved Confidential

 

 

American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 Authority to Act as Agent To Whom It May Concern:

Remote Diagnostic Technologies Ltd is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). Thalwil, 07.06.2019 We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date: 07.06.2020 By:

Filip Kruzela Title:

Certification Manager On behalf of:

u-blox Telephone: +46 40 630 71 70 u-blox AG Zrcherstrasse 68 8800 Thalwil Switzerland Phone +41 44 722 74 44 Fax +41 44 722 74 47 info@u-blox.com www.u-blox.com 1/

 

 

 

 

 

 

rOTS 4 Philips company 2 April 2019 Federal Communications Commission Office of Engineering and Technology Equipment Authorization Division 7345 Oakland Mills Road Columbia, Maryland 21046 Subject: Class II permissive change request for FCC ID:PV7-WIBEARI11N-DF2 To whom it may concern U-Blox wish to submit a Class II Permissive Change to demonstrate that FCC human exposure requirements and FCC multi-

transmitter rules have been complied with, when collocating modules FCC [D:PV7-WIBEARI11N-DF2 and FCC ID:NCMOMO6012 into the Remote Diagnostics Technologies Ltd Tempus Pro:

No hardware modifications have been required either module EMF compliance for permitted modes of operation has been demonstrated by SAR testing Simultaneously transmission combinations are discussed in the operational description. Yours Sincerely Leigh Cornock Remote Diagnostic Technologies Ltd PHILIPS RDT, a Philips company Pavilion C2, Ashwood Park, Ashwood Way, Basingstoke, Hampshire, RG23 8BG, UK, www.rdtltd.com, Tel number +44 1256 362 400, Fax number +44 1256 362 415, Registered in England No.3321782, VAT No.692 9012 19.

 

 

1 2 3

(OTS A Philips company Request for Confidentiali Date: June 18, 2019 Subject: Confidentiality Request for: FC: IDPV7-W1BEAR11N-DF2 and IC:7738A-WB11NDF2 Pursuant to FCC 47 CFR 0.457(d) and 0.459 and IC RSP-100, Section 9.4, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit C1 Short Term L] Permanent Block Diagrams C1 Short Term External Photos CL) Short Term C1 Short Term CJ Short Term CL] Short Term C1] Short Term C1] Short Term LC] Short Term C1 Permanent *!

x] Permanent L] Permanent L] Permanent L] Permanent C Permanent *3 Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics Test Setup Photos Users Manual u-Blox has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of

(specify number of days not to exceed 180)? __ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public before the requested period has expired. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

IC currently only distinguishes Permanent Confidentiality exhibits as shown above. Short Term confidentiality is not considered applicable to IC applications. Sincerely, x ; | yak . , ; j By: L > Cal Nrreclor AN L@i ah Co reo ole.

(Signture/Title*) (Print name)

- The asterisked items (*) require further information to be provided to ACB before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for D01 found at:

https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=4 1731 and review section II, 3) regarding specific information that must accompany these requests.

- Please refer to http://acbcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details.

- Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead. PH Lu ps RDT, a Philips company Pavilion C2, Ashwood Park, Ashwood Way, Basingstoke, Hampshire, RG23 8BG, UK, www.rdtltd.com, Tel number +44 1256 362 400, Fax number +44 1256 362 415, Registered in England No.3321782, VAT No.692 9012 19.

 

 

Tempus Pro variants 00-1026-R: standard configuration with printer, ECG monitoring, NIBP, pulse oximetry (SpO2), impedance respiration, invasive pressure (2 channels), ETCO2 and contact temperature (1 or 2 channels). Includes 2G/3G Cellular modem (Option GTM601W) and Wi-Fi / BT (U-Blox ELLA W-163). 00-1024-R: as 00-1026-R without invasive pressure (2 channels). 00-1004-R: as 00-1026-R without printer / detachable Bluetooth headset. 00-1007-R: as 00-1026-R without printer and with detachable Bluetooth headset.