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UM part panel | Users Manual | 41.68 KiB | April 04 2013 / May 10 2013 | |||
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Users Manual | Users Manual | 426.95 KiB | ||||
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user manual (M) | Users Manual | 406.43 KiB | ||||
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user manual (S)Ver 2 | Users Manual | 543.39 KiB | ||||
1 2 3 | Cover Letter(s) | |||||||
1 2 3 | ID Label/Location Info | |||||||
1 2 3 | RF Exposure Info | |||||||
1 2 3 | Cover Letter(s) | |||||||
1 2 3 | External Photos | |||||||
1 2 3 | Internal Photos | |||||||
1 2 3 | Cover Letter(s) | April 04 2013 / August 04 2013 | ||||||
1 2 3 | Attestation Statements | April 04 2013 / August 04 2013 | ||||||
1 2 3 | External Photos | April 04 2013 / May 10 2013 | ||||||
1 2 3 | Internal Photos | April 04 2013 / May 10 2013 | ||||||
1 2 3 | ID Label/Location Info | April 04 2013 / August 04 2013 | ||||||
1 2 3 | ID Label/Location Info | April 04 2013 / August 04 2013 | ||||||
1 2 3 | Test Setup Photos | April 04 2013 / May 10 2013 | ||||||
1 2 3 | RF Exposure Info | April 04 2013 / August 04 2013 | ||||||
1 2 3 | RF Exposure Info | April 04 2013 / August 04 2013 | ||||||
1 2 3 | Attestation Statements | |||||||
1 2 3 | Attestation Statements | |||||||
1 2 3 | External Photos | |||||||
1 2 3 | RF Exposure Info | |||||||
1 2 3 | RF Exposure Info | |||||||
1 2 3 | RF Exposure Info | |||||||
1 2 3 | RF Exposure Info | |||||||
1 2 3 | Internal Photos | |||||||
1 2 3 | ID Label/Location Info | |||||||
1 2 3 | Attestation Statements | |||||||
1 2 3 | Test Setup Photos | |||||||
1 2 3 | Test Report | |||||||
1 2 3 | Test Setup Photos |
1 2 3 | UM part panel | Users Manual | 41.68 KiB | April 04 2013 / May 10 2013 |
Note to users in the United States of America Notice:
to part 15 of the FCC Rules. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant These limits are designed to provide reasonable protection against harmful interference in a residential installation. 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. Increase the separation between the equipment and receiver. 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. The product with the Wireless device has been tested to SAR and complies with FCC exposure requirements for portable devices.The SAR test has been done at distance of 0cm from the body. Warning:
Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. Caution:
The available scientific evidence does not show that any health problems are associated with using low power wireless devices. There is no proof, however, that these low power wireless devices are absolutely safe. Low power Wireless devices emit low levels of radio frequency energy (RF) in the microwave range while being used. Whereas high levels of RF can produce health effects (by heating tissue), exposure of low-level RF that does not produce heating effects causes no known adverse health effects. Many studies of low-level RF exposures have not found any biological effects. Some studies have suggested that some biological effects might occur, but such findings have not been confirmed by additional research. Operational Panel with RYYWYSAAVDX7 has been tested and found to comply with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65.
1 2 3 | Users Manual | Users Manual | 426.95 KiB |
6-May.2011 Ver.0.6 TAIYO YUDEN Tentative WYSAAVDX7 Wireless LAN Module WYSAAVDX7
(IEEE802.11b/g/n) User Manual In case you adopt this module and design some appliance, please ask for the latest specifications from the local sales office. We wish the customer to request the Specification Report when the design for the mass production begins because the content of this Data Report might change without a previous notice to the customer. TAIYO YUDEN 1/20 WYSAAVDX7 Document constituent list Control name General Items Absolute maximum ratings Electrical characteristics Circuit schematic Outline / Appearance Pin Layout Label Information Regulatory Information Rev. records 9-Mar.-2011> Ver.0.5 6-May-2011> Ver.0.6 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control No. HD-AG-A100174 HD-AM-A100174 HD-AE-A100174 HD-MC-A100174 HD-AD-A100174 HD-BA-A100174 HD-CA-A100174 HD-CB-A100174 Document Page 1/2 - 2/2 1/1 1/5 - 5/5 1/1 1/1 1/1 1/1 1/6 6/6 TAIYO YUDEN 2/20 WYSAAVDX7 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control name General Items Control No. HD-AG-A100174 (1/2) Scope This specification (Specification) applies to the hybrid IC for use Wireless LAN module (Product) manufacture by TAIYO YUDEN Co., Ltd. (TAIYO YUDEN) 1. User Code: WYSAAVDX7 Digit3: Customer Code ex) S: TAIYO YUDEN Standard Digit8: Software Code ex) X: TAIYO YUDEN Standard Digit9: Hardware Code ex) 7: TAIYO YUDEN Standard
* User Code may be modified for mass production or other cases. Please see k for more information. 2. Function: Radio frequency transfer Module. (IEEE802.11bgn standard conformity) 3. Application: PC peripheral, Handy terminal 4. Structure: Hybrid IC loaded with silicon monolithic and GaAs semiconductor Ability of lead free mounting at customer's assembly (Heat resistance of this Product) : Yes Containment of hazardous substance in this Product
*This product conforms to RoHS Directive (2002/95/EC). 5. Outline: Stacking Connector Type 6. Marking: TBD 7. Features:
-IEEE802.11bgn standard conformity
-Interface: SDIO
-Embedded MPU for reducing loads on host processor
-Built-in EEPROM (MAC address) 8. Security: WEP (64/128), TKIP, AES, WPA, WPA2, WAPI 9. Packing: TBD 10. Terminal: Data input-output (20pin Stacking Connector) Panasonic Electric Works Co., Ltd: AXK820145WG RF input-output (Antenna) 11. Mount: with M2 screw 12. Notes:
a. Any question arising from this Specification shall be solved through mutual discussion by the parties hereof. radiation. b. This Product is not designed for radiation durable and should not be used under the circumstance of c. The operating conditions of this Product are as shown in this Specification. Please note that TAIYO YUDEN shall not be liable for a failure and/or abnormality which is caused by use under the conditions other than the operating conditions hereof. d. This Product mentioned in this Specification is manufactured for use in consumer products. Before using this Product in any special equipment (such as medical equipment, space equipment, air craft, disaster prevention equipment), where higher safety and reliability are duly required, the applicability and suitability of this Product must be fully evaluated by the customer at its sole risk to ensure correct and safety operation of those special equipments. Also, evaluation of the safety function of this Product even for use in general electronics equipment shall be thoroughly made and when necessary, a protective circuit shall be added at design stage, all at the customers sole risk. TAIYO YUDEN 3/20 WYSAAVDX7 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control name General Items Control No. HD-AG-A100174 (2/2) e. i) You are requested to fully check and confirm by the start of mass production of this Product that (1) no bug, defect or other failure is included in firmware incorporated in this Product (Incorporated Software),
(2) no bug defect or other failure is caused by installation of this Product with Incorporated Software into customers products, and that Incorporated Software fully meets customers intended use, although TAIYO YUDEN sufficiently inspects or verifies quality of Incorporated Software. ii) Please note that TAIYO YUDEN is not responsible for any failure arising out of bugs or defects in Incorporated Software. f. TAIYO YUDEN warrants only that this Product is in conformity with this Specification for one year after purchase and shall in no event give any other warranty. g. Communication between this Product and others might not be established nor maintained depending upon radio environment or operating conditions of this Product and other ISM band at 2.4GHz products. h. In order to take tests for getting the certification of each countrys Radio Law with a device incorporating this module, it is necessary to make the software in Host to put the module into test condition. Please contact TAIYO YUDEN for further details. i. This Product operates in the unlicensed ISM band at 2.4GHz. In case this Product is used around the other wireless devices which operate in same frequency band of this Product, there is a possibility that interference occurs between this Product and such other devices. If such interference occurs, please stop the operation of other devices or relocate this Product before using this Product or do not use this Product around the other wireless devices. j. Please evaluate adequately our module incorporated to your products before mass production. k. User Code Modification Notice. User Code for sample modules or part numbers you see in this Specification are TAIYO YUDEN standard part numbers. When any modification is made to modules to meet requested specifications, the part number will carry a different part number, due to forfeit originality. Additionally, part numbers may be modified based on mass production stage or other related stages. Please contact TAIYO YUDEN to confirm whether your part number needs to be modified. Please see the following examples for cases that part numbers are modified:
- for specific firmware version (our standard item firmware will be upgraded occasionally)
- for specific MAC address (our standard item MAC address is owned by TAIYO YUDEN )
- for other relevant cases (specific or different setting, form, sizes, or display etc..) m. In some cases, TAIYO YUDEN may use replacements as component parts of Products. Such replacement shall apply only to component part of Products, which TAIYO YUDEN deems it possible to replace or substitute according to (i) Scope provided in this Specification (e.g. Official Standard (Type Approvals etc.)) and (ii) Quality of Products. TAIYO YUDEN also ensures traceability of such replacement on production lot basis. n. Do not alter Hardware and/or Software of this Product. Please note that TAIYO YUDEN shall not be liable for any problem if it is caused by customer's alteration of Hardware or/and Software without Taiyo Yuden's prior approvals. p. Caution for Export Control This Product may be subject to governmental approvals, consents, licenses, authorizations, declarations, filings, and registrations for export or re-export of the Product, required by Japanese Foreign Exchange and Foreign Trade Law(including related laws and regulations) and/or any other countrys applicable laws or regulations related to export control. In case you will export or re-export this Product, you are strongly recommended to check and confirm, before exporting or re-exporting, necessary procedures for export or re-export of this Product which is required by applicable laws and regulations, and if necessary, you have to obtain necessary and appropriate approvals or licenses from governmental authority at your own risk and expense. TAIYO YUDEN 4/20 WYSAAVDX7 Control No. HD-AM-A100174 (1/1) Control name Absolute maximum ratings 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Absolute maximum ratings Item Supply voltage 1 Supply voltage 2 Storage temperature range Operation temperature range Symbol VBAT VIO Tstg Topr Min.
-0.3
-30
-20 Recommendation operating range Item Supply voltage 1 Supply voltage 2 Symbol VBAT VIO Min. 3.5 1.62/2.97 Rating Typ. 25 Rating Typ. 5.0 1.8/3.3 Max. 6.0 4.0 100 55 Unit Remark V V Degrees C Degrees C Max. 5.5 1.98/3.63 Unit Remark V V TAIYO YUDEN 5/20 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Max. 30 400 TBD TBD TBD TBD TBD TBD TBD TBD
Remark Unit mA mA mW Duty 2.4%
mW mW Duty 4.2%
mW mW Duty 25.4%
mW mW Duty 43.4%
mW mW mW VIO=3.3V VIO=1.8V VIO=3.3V VIO=1.8V Remark Max. VIO+0.3 0.3xVIO
0.4 Unit V V V V WYSAAVDX7 Control No. HD-AE-A100174 (1/5) Control name Electrical characteristics Symbol Condition Parameter VIO VBAT DC Specifications Peak Current / Power consumption The Specification applies for Topr.= 25 degrees C, Supply voltage=Typical voltage (5.0V). RF output power = Typ. No. 1 Peak Current1 2 Peak Current2 4 Power consumption1 Burst Tx (150Mbps) 5 Power consumption2 Continuous Rx (150Mbps) 6 Power consumption3 Burst Tx (72.2Mbps) 7 Power consumption4 Continuous Rx (72.2Mbps) 8 Power consumption5 Burst Tx (54Mbps) 9 Power consumption6 Continuous Rx (54Mbps) 10 Power consumption7 Burst Tx (11Mbps) 11 Power consumption8 Continuous Rx (11Mbps) TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD Ip1 Ip2 Pc1 Pc2 Pc3 Pc4 Pc5 Pc6 Pc7 Pc8 Min. Typ.
12 Power consumption9 Power save mode
(DTIM=1, Beacon interval =100ms) 13 Power consumption10 Deep Sleep Pc9 Pc10 Digital Pad Ratings No. Parameter 1 2 3 Output high voltage 4 Output low voltage Input high voltage Input low voltage Condition Symbol VIH VIL VOH VOL
Min. 0.7xVIO
-0.3 VIO-0.4
TBD TBD TBD TBD Typ. TAIYO YUDEN 6/20 WYSAAVDX7 Control No. HD-AE-A100174 (2/5) Control name Electrical characteristics 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative AC Specifications Power-on timing / External sleep clock Parameter 1 Valid Power / RESETn / Clock to PDn de-asserted 2 3 4 5 6 7 Input SLP_CLK frequency Input SLP_CLK high voltage Input SLP_CLK low voltage Input SLP_CLK phase noise requirement Input SLP_CLK slew rate limit (10-90%) Input SLP_CLK duty cycle tolerance Condition Symbol Min 300 0.8 0.0 20 Tpor Tf VIH VIL PN SR DC Typ Max 32.768 1.8
-125 1.98 0.25 100 80 Remark Unit ms KHz V V dBc/Hz @100KHz ns
<Power-on sequence>
PDn must remain asserted for minimum of Tpor after VBAT, VIO and SLP_CLK are stable. RESETn must be inactive value (asserted high) when PDn is de-asserted (high level). VBAT VIO PDn SLP_CLK
(32.768KHz) Tpor Tf Typ Max External reset(RESETn), power down(PDn) Parameter Condition Symbol Min 1 300 Unit ms ms Remark Note1 Notes2, 3 RESETn pulse width 1 2 1. RESETn should be asserted while VBAT, VIO and SLP_CLK are stable and PDn is de-asserted (high level). 2. PDn should be asserted while VBAT, VIO and SLP_CLK are stable and RESETn is de-asserted (high level). 3. For lowest current consumption, apply all power rails to WYSAAVDX7 during the assertion of PDn pin. PDn pulse width Trpw Tppw Trpw Tppw RESETn PDn TAIYO YUDEN 7/20 WYSAAVDX7 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control No. HD-AE-A100174 (3/5) Control name Electrical characteristics SDIO Interface Specifications The Specification applies for Topr.= -20 to TBD degrees C , Supply voltage=Typical voltage(5.0V). Parameter Symbol 1 Input SDIO_CLK Frequency 2 Input SDIO_CLK High Time 3 Input SDIO_CLK Low Time 4 Input SDIO_CMD, DATA[3:0] Setup time 5 Input SDIO_CMD, DATA[3:0] Hold time 6 Output SDIO_CMD, DATA[3:0] Delay time 7 Output SDIO_CMD, DATA[3:0] Hold time Tf Tch Tcl Tsu Thd Tod Toh Remark MHz ns 25 50
Typ Max Unit
ns ns 7.33 ns ns ns
Condition Min 0 0 10 7 10 7 5 6 5 2
2.5 Normal High Speed Normal High Speed Normal High Speed Normal High Speed Normal High Speed
High Speed Tf Tch Tcl SD_CMD SD_DATA[3:0]
SD_CMD SD_DATA[3:0]
SD_CLK HOST > WiFi WiFi > HOST Normal Mode High Speed Mode WiFi > HOST HOST > WiFi SD_CLK SD_CMD SD_DATA[3:0]
SD_CMD SD_DATA[3:0]
Tsu Thd Tod Tf Tch Tcl Tsu Thd Toh Tod TAIYO YUDEN 8/20 WYSAAVDX7 Control No. HD-AE-A100174 (4/5) Control name Electrical characteristics 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative RF Specifications (WLAN 11n/150Mbps, OFDM) The Specification applies for Ta=25 degrees C, Supply voltage =Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power Condition Typ Max Unit Remark
-66 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 RF Specifications (WLAN 11n/72.2Mbps, OFDM) The Specification applies for Ta=25 degrees C, Supply voltage =Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power SEN MIL ROS1 ROS2
-20
Condition Typ Max Unit Remark 1st Side Lobe 2nd Side Lobe 3rd Side Lobe Rms 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<10%
PER<10%
30MHz to 1GHz 1GHz to 12.75GHz 1st Side Lobe 2nd Side Lobe 3rd Side Lobe Rms 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<10%
PER<10%
30MHz to 1GHz 1GHz to 12.75GHz 3 Spectrum Mask 4 Symbol clock tolerance 5 Frequency tolerance 6 EVM 7 TX Out of band spurious1 8 TX Out of band spurious2 9 TX Out of band spurious3 3 Spectrum Mask 4 Symbol clock tolerance 5 Frequency tolerance 6 7 TX Out of band spurious1 8 TX Out of band spurious2 EVM 9 TX Out of band spurious3 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 Po M1 M2 M3 Ft Ft Symbol Min 2422 FREQ 9
-25
-25
EVM TOS1 TOS2 TOS3 Po M1 M2 M3 Ft Ft Symbol Min 2412 FREQ 9
-25
-25
EVM TOS1 TOS2 TOS3 SEN MIL ROS1 ROS2
-20
-69 11 11 2462 MHz dBm 13
-20 dBc dBc
-28 dBc
-45 25 ppm ppm 25 dB
-28 dBm
-36
-30 dBm
-47
-61
-57
-47 dBm dBm dBm dBm dBm 2472 MHz dBm 13
-20 dBc dBc
-28 dBc
-45 25 ppm ppm 25 dB
-28 dBm
-36
-30 dBm
-47
-64
-57
-47 dBm dBm dBm dBm dBm TAIYO YUDEN 9/20 WYSAAVDX7 Control No. HD-AE-A100174 (5/5) Control name Electrical characteristics 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative RF Specifications (WLAN 11g/54Mbps, OFDM) The Specification applies for Ta=25 degrees C, Supply voltage =Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power Condition Typ Max Unit Remark
-72 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 RF Specifications (WLAN 11b/11Mbps, CCK) The Specification applies for Ta=25 degrees C, Supply voltage=Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power SEN MIL ROS1 ROS2
-20
Condition Typ Max Unit Remark 1st Side Lobe 2nd Side Lobe 3rd Side Lobe Rms 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<10%
PER<10%
30MHz to 1GHz 1GHz to 12.75GHz 1st Side Lobe 2nd Side Lobe Power up Power down Peak 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<8%
PER<8%
30MHz to 1GHz 1GHz to 12.75GHz 3 Spectrum Mask 4 Symbol clock tolerance 5 Frequency tolerance 6 EVM 7 TX Out of band spurious1 8 TX Out of band spurious2 9 TX Out of band spurious3 3 Spectrum Mask 4 Power up-down rump 5 Frequency tolerance 6 EVM 7 TX Out of band spurious1 8 TX Out of band spurious2 9 TX Out of band spurious3 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 Po M1 M2 M3 Ft Ft Symbol Min 2412 FREQ 10
-25
-25
EVM TOS1 TOS2 TOS3 Po M1 M2 TU TD Ft Symbol Min 2412 FREQ 13
-25
EVM TOS1 TOS2 TOS3 SEN MIL ROS1 ROS2
-10
-86 12 15 2472 MHz dBm 14
-20 dBc dBc
-28 dBc
-40 25 ppm ppm 25 dB
-25 dBm
-36
-30 dBm
-47
-65
-57
-47 dBm dBm dBm dBm dBm 2472 MHz dBm 17
-30 dBc dBc
-50 us 2 2 us ppm 25
35 dBm
-36
-30 dBm
-47
-76
-57
-47 dBm dBm dBm dBm dBm TAIYO YUDEN 10/20 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative WYSAAVDX7 Control No. HD-MC-A100174 (1/1) Control name Circuit Schematic Block Diagram Antenna DCDC 3.3V LDO 1.8V PA BPF SP3T TX RX 88W8787 r o t c e n n o C 5V VIO Slow Clock SDIO Other (4) EEPROM Crystal TAIYO YUDEN 11/20 WYSAAVDX7 Control No. HD-AD-A100174 (1/1) Control name Outline/Appearance 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Unit: mm, Tolerances unless otherwise specified: 0.2mm 35.00.3 33.15 1.25 Power Block Shielding Case
0
. 3
0
. 1 2
. 0 1 4
. 0 1 5
. 0 1 2
. 2 5 2.66 13.05 13.6 5.0 2.5 D2.00.1 5 0
. 5 1
. 5
. 7 5 2.7 1 2
. 5 0 3
. M a x
. 2
. 9 M a x
. 1
. 7 M a x
. 1
. 3 M a x
. 1
. 2 M a x
. 1 3 5 M a x
. 2 6
. 1
. 1 0 1
. 5 0
. 5.0 Indication Label TAIYO YUDEN 12/20 WYSAAVDX7 Control No. HD-BA-A100174 (1/1) Control name Pin Layout 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Pin Descriptions Terminal No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Terminal Name Input/ Output Pwr Domain Description Function GND SD_DATA1 SD_DATA0 GND SD_CLK VIO SD_CMD SD_DATA3 SD_DATA2 GND GND SLP_CLK GND PDn RESETn WL_HOST_WKUP HOST_WL_WKUP GND VBAT VBAT
Input/Output Input/Output
Input Input Input/Output Input/Output Input/Output
Input
Input Input Input Output
Input Input GND VIO VIO GND VIO VIO VIO VIO VIO GND GND 1.8V GND VIO VIO VIO VIO GND VBAT VBAT Ground SDIO Data-1 SDIO Data-0 Ground SDIO Clock 1.8V/3.3V Digital I/O Power Supply SDIO Command SDIO data-3 SDIO data-2 Ground Ground Sleep Clock (32.768kHz) Used for WLAN low-power modes. Ground Power Down (active low) with internal pull-up. Reset (active low) with internal pull-up. WLAN wakeup HOST wakeup Ground 5.0V Power Supply 5.0V Power Supply Power SDIO SDIO Power SDIO Power SDIO SDIO SDIO Power Power System Power System System System System Power Power Power TAIYO YUDEN 13/20 WYSAAVDX7 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control No. HD-CA-A100174 (1/1) Control name Label Information 1) Type WYSAAVDX7 2) Manufacturer Taiyo Yuden Co.,Ltd. 3) R&TTE CE mark Specified CE mark 4) FCC ID RYYWYSAAVDX7 5) IC ID 4389B-WYSAAVDX7 6) Japan logo mark and ID Specified logo mark and XXXXXXXXXXX 7) Country of Origin China 8) MAC Address XXXXXXXXXXXX 9) ARIB Actual IndicationIndicates that this device is Second Generation Low Power Data Communication System 10) Lot Number XXXX 11) DC mark and Operating Input Voltage DC mark and 5.0V 12) User Code XXXXXXXXX 13) UAE ID TRA Logo and REGISTERED No and DEALER No 3) 4) 5) 1) 11) 9) 33.0 MODEL: WYSAAVDX7 FCC ID: RYYWYSAAVDX7 IC: 4389B-WYSAAVDX7 2.4DS/OF4 5.0V R 001WWCA1266 User Code: XXXXXXXXX User Code:
WYSAAVDX7-XE 5 3
. 0 3 1 XXXXXXXXXXXX Taiyo Yuden Co., Ltd. XXXXX Made in CHINA 27.5 TRAREGISTERED No:
nnnnnn DEALER No:
xxxxxxxxx 5 5
. 5 7
. 0 3 6.0
. 5 2 2.5 13) 6) 8) 2) 12) 10) 7) TAIYO YUDEN 14/20 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control name Regulatory Information WYSAAVDX7 Control No. HD-CB-A100174 (1/6) Regulatory Information 1) Japan Regulatory Information This product with a specific antenna is a radio system approved for Type Approval. Please follow the instructions below on designing your product. a) Please notify clearly below sentences in the product manual. This product has a radio system which was approved as a radio station in a low power data communication system based on the Radio Law and the Telecommunication Business Law. Name of the radio system: XXXXXXXXXXX b) Please design your set structure in which this module can be easily attached and taken off by end users (consumer public). c) This module is certified by Type Approval as the device which has SDIO Interface. Please do not use other purposes except that of certified. Please contact Taiyo Yuden for more details of purposes of this product. TAIYO YUDEN 15/20 WYSAAVDX7 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control No. HD-CB-A100174 (2/6) Control name Regulatory Information 2) Canada Regulatory Information License-exempt low-power radiocommunication devices are required to describe following or equivalent sentences in user manuals in section 7.1.5 User Manual of Canadian regulations RSS-GEN. Therefore TAIYO YUDEN recommends describing an appropriate comment in your product manual. 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. L'utilisation de ce dispositif est autorise seulement aux conditions suivantes: (1) il ne doit pas produire de brouillage et (2) l'utilisateur du dispositif doit tre prt accepter tout brouillage radiolectrique reu, mme si ce brouillage est susceptible de compromettre le fonctionnement du dispositif. Your product has been applied to requests of ICES. In some applied regulations, there are mention requirements. Therefore please confirm applied regulations. In the case of ICES-003:
Example 1 Canadian Radio Interference Regulations This digital apparatus does not exceed Class B limits for radio noise emissions from a digital apparatus as set out in the interference-causing equipment standard entitled Digital Apparatus, ICES-003 of the Industry Canada. Cet appareil numrique respecte les limites de bruits radio lctiques applicables aux appareils numriques de Classe B prescrites dans la norme sur le matriel brouilleur: "Appareils Numriques", NMB-003 dicte par l'Industrie Canada. Example 2 This Class [*] digital apparatus complies with Canadian ICES-003. Cet appareil numrique de la classe [*] est conforme la norme NMB-003 du Canada.
[*] Insert either "A" or "B" but not both as appropriate for the equipment requirements. The following sentence has to be displayed on the outside of the device in which the module is installed: Contains Transmitter Module IC : 4389B-WTSAAVDX7, or
"Contains IC : 4389B-WYSAAVDX7". TAIYO YUDEN 16/20 WYSAAVDX7 Control No. HD-CB-A100174 (3/6) 3) FCC Regulatory Information 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Control name Regulatory Information Please describe contents mentioned below in users manual of your company. CAUTION: To maintain compliance with FCCs RF exposure guidelines, use only the supplied antenna. Unauthorize antenna, modification, or attachments could damage the transmitter and may violate FCC regulations. 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.
(2) This device must accept any interference received, including interference that may cause undesired operation. The following sentence has to be displayed on the outside of the device in which the module is installed: Contains Transmitter Module FCC ID: RYYWYSAAVDX7, or Contains FCC ID: RYYWYSAAVDX7 . CAUTION: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. TAIYO YUDEN 17/20 WYSAAVDX7 Control No. HD-CB-A100174 (4/6) Control name Regulatory Information 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative 4) CE EN 300 328 V1.7.1: (2006-10) Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband Transmission systems;
Data transmission equipment operating in the 2,4 GHz ISM band and using spread spectrum modulation techniques; Harmonized EN covering essential requirements under article 3.2 of the R&TTE Directive EN 301 489-1 V1.8.1: (2008) Electromagnetic compatibility and Radio Spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements EN 301 489-17 V2.1.1 (2009) Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for 2,4 GHz wideband transmission systems and 5 GHz high performance RLAN equipment This device is a 2.4 GHz wideband transmission system (transceiver), intended for use in all EU member states and EFTA countries, except in France and Italy where restrictive use applies. In Italy the end-user should apply for a license at the national spectrum authorities in order to obtain authorization to use the device for setting up outdoor radio links and/or for supplying public access to telecommunications and/or network services. This module does not intend to use it with cables more than 3m. TAIYO YUDEN 18/20 WYSAAVDX7 Control No. HD-CB-A100174 (5/6) Control name Regulatory Information 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative esky
[Czech]
Dansk
[Danish]
Deutsch
[German]
Eesti
[Estonian]
English Espaol
[Spanish]
[Greek]
Franais
[French]
Italiano
[Italian]
Latviski
[Latvian]
Lietuvi
[Lithuanian]
Nederlands
[Dutch]
Malti
[Maltese]
Magyar
[Hungarian]
Polski
[Polish]
[Taiyo Yuden] tmto prohlauje, e tento [WYSAAVDX7] je ve shod se zkladnmi poadavky a dalmi pslunmi ustanovenmi smrnice 1999/5/ES. Undertegnede [Taiyo Yuden] erklrer herved, at flgende udstyr [WYSAAVDX7]
overholder de vsentlige krav og vrige relevante krav i direktiv 1999/5/EF. Hiermit erklrt [Taiyo Yuden], dass sich das Gert [WYSAAVDX7]
in bereinstimmung mit den grundlegenden Anforderungen und den brigen einschlgigen Bestimmungen der Richtlinie 1999/5/EG befindet. Kesolevaga kinnitab [Taiyo Yuden] seadme [WYSAAVDX7] vastavust direktiivi 1999/5/E phinuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele stetele. Hereby, [Taiyo Yuden], declares that this [WYSAAVDX7] is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Por medio de la presente [Taiyo Yuden] declara que el [WYSAAVDX7] cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999/5/CE.
[Taiyo Yuden] [WYSAAVDX7]
1999/5/. Par la prsente [Taiyo Yuden] dclare que l'appareil [WYSAAVDX7] est conforme aux exigences essentielles et aux autres dispositions pertinentes de la directive 1999/5/CE. Con la presente [Taiyo Yuden] dichiara che questo [WYSAAVDX7] conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE. Ar o [Taiyo Yuden] deklar, ka [WYSAAVDX7] atbilst Direktvas 1999/5/EK btiskajm prasbm un citiem ar to saisttajiem noteikumiem. iuo [Taiyo Yuden] deklaruoja, kad is [] atitinka esminius reikalavimus ir kitas 1999/5/EB Direktyvos nuostatas. Hierbij verklaart [Taiyo Yuden] dat het toestel [WYSAAVDX7] in overeenstemming is met de essentile eisen en de andere relevante bepalingen van richtlijn 1999/5/EG. Hawnhekk, [Taiyo Yuden], jikkonforma mal-tiijiet essenzjali u ma provvedimenti orajn relevanti li hemm fid-Dirrettiva 1999/5/EC. Alulrott, [Taiyo Yuden] nyilatkozom, hogy a [WYSAAVDX7] megfelel a vonatkoz alapvet kvetelmnyeknek s az 1999/5/EC irnyelv egyb elrsainak. Niniejszym [Taiyo Yuden] owiadcza, e [WYSAAVDX7] jest zgodny z zasadniczymi wymogami oraz pozostaymi stosownymi postanowieniami Dyrektywy 1999/5/EC. li dan [WYSAAVDX7]
jiddikjara TAIYO YUDEN 19/20 WYSAAVDX7 Control No. HD-CB-A100174 (6/6) Control name Regulatory Information 6-May.2011 Ver.0.6 TAIYO YUDEN Tentative Portugus
[Portuguese]
Slovensko
[Slovenian]
Slovensky
[Slovak]
Suomi
[Finnish]
Svenska
[Swedish]
[Taiyo Yuden] declara que este [WYSAAVDX7] est conforme com os requisitos essenciais e outras disposies da Directiva 1999/5/CE.
[Taiyo Yuden] izjavlja, da je ta [WYAAVDX7] v skladu z bistvenimi zahtevami in ostalimi relevantnimi doloili direktive 1999/5/ES.
[Taiyo Yuden] tmto vyhlasuje, e [WYSAAVDX7] spa zkladn poiadavky a vetky prslun ustanovenia Smernice 1999/5/ES.
[Taiyo Yuden] vakuuttaa tten ett [WYSAAVDX7] tyyppinen laite on direktiivin 1999/5/EY oleellisten vaatimusten ja sit koskevien direktiivin muiden ehtojen mukainen. Hrmed intygar [Taiyo Yuden] att denna [WYSAAVDX7] str I verensstmmelse med de vsentliga egenskapskrav och vriga relevanta bestmmelser som framgr av direktiv 1999/5/EG. TAIYO YUDEN 20/20
1 2 3 | user manual (M) | Users Manual | 406.43 KiB |
13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative WYSAAVDX7 Wireless LAN Module WYSAAVDX7
(IEEE802.11b/g/n) User Manual In case you adopt this module and design some appliance, please ask for the latest specifications from the local sales office. We wish the customer to request the Specification Report when the design for the mass production begins because the content of this Data Report might change without a previous notice to the customer. TAIYO YUDEN 1/16 WYSAAVDX7 Document constituent list Control name General Items Absolute maximum ratings Electrical characteristics Circuit schematic Outline / Appearance Pin Layout Rev. records 9-Mar.-2011> Ver.0.5 6-May-2011> Ver.0.6 4-Apr.-2012> Ver.0.7 1-Apr.-2013> Ver.0.8 13-Nov.-2013>Ver.0.9 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Control No. HD-AG-A100174 HD-AM-A100174 HD-AE-A100174 HD-MC-A100174 HD-AD-A100174 HD-BA-A100174 Document Page 1/4 4/4 1/1 1/5 - 5/5 1/1 1/2 2/2 1/1 TAIYO YUDEN 2/16 WYSAAVDX7 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Control name General Items Control No. HD-AG-A100174 (1/4) Scope This specification (Specification) applies to the hybrid IC for use Wireless LAN module (Product) manufacture by TAIYO YUDEN Co., Ltd. (TAIYO YUDEN) 1. User Code: WYSAAVDX7 Digit3: Customer Code ex) S: TAIYO YUDEN Standard Digit8: Software Code ex) X: TAIYO YUDEN Standard Digit9: Hardware Code ex) 7: TAIYO YUDEN Standard
* User Code may be modified for mass production or other cases. Please see m for more information. 2. Function: Radio frequency transfer Module. (IEEE802.11bgn standard conformity) 3. Application: PC peripheral, Handy terminal 4. Structure: Hybrid IC loaded with silicon monolithic and GaAs semiconductor Ability of lead free mounting at customer's assembly (Heat resistance of this Product) : Yes Containment of hazardous substance in this Product
*This product conforms to RoHS Directive (2002/95/EC). 5. Outline: Stacking Connector Type 6. Marking: IC ID, FCC ID, Japan ID, MAC address and Lot at label on the bottom side. 7. Features:
-IEEE802.11bgn standard conformity
-Interface: SDIO
-Embedded MPU for reducing loads on host processor
-Built-in EEPROM (MAC address) 8. Security: WEP (64/128), TKIP, AES, WPA, WPA2, WAPI 9. Packing: Packaging method: Tray Packaging unit: 90pcs./tray 1080pcs./Box 10. Terminal: Data input-output (20pin Stacking Connector) Panasonic Electric Works Co., Ltd: AXK820145WG RF input-output (Antenna) 11. Mount: with M2 screw 12. Notes:
a. Any question arising from this Specification shall be solved through mutual discussion by the parties hereof. radiation. b. This Product is not designed for radiation durable and should not be used under the circumstance of c. The operating conditions of this Product are as shown in this Specification. Please note that TAIYO YUDEN shall not be liable for a failure and/or abnormality which is caused by use under the conditions other than the operating conditions hereof. d. Please note that this users manual should not be provided to end-users. e. The antenna used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. f. This Product mentioned in this Specification is manufactured for use in consumer products. Before using this Product in any special equipment (such as medical equipment, space equipment, air craft, disaster prevention equipment), where higher safety and reliability are duly required, the applicability and suitability of this Product must be fully evaluated by the customer at its sole risk to ensure correct and TAIYO YUDEN 3/16 WYSAAVDX7 Control No. HD-AG-A100174 (2/4) Control name General Items 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative safety operation of those special equipments. Also, evaluation of the safety function of this Product even for use in general electronics equipment shall be thoroughly made and when necessary, a protective circuit shall be added at design stage, all at the customers sole risk. g. i) You are requested to fully check and confirm by the start of mass production of this Product that (1) no bug, defect or other failure is included in firmware incorporated in this Product (Incorporated Software),
(2) no bug defect or other failure is caused by installation of this Product with Incorporated Software into customers products, and that Incorporated Software fully meets customers intended use, although TAIYO YUDEN sufficiently inspects or verifies quality of Incorporated Software. ii) Please note that TAIYO YUDEN is not responsible for any failure arising out of bugs or defects in Incorporated Software. h. TAIYO YUDEN warrants only that this Product is in conformity with this Specification for one year after purchase and shall in no event give any other warranty. i. Communication between this Product and others might not be established nor maintained depending upon radio environment or operating conditions of this Product and other ISM band at 2.4GHz products. j. In order to take tests for getting the certification of each countrys Radio Law with a device incorporating this module, it is necessary to make the software in Host to put the module into test condition. Please contact TAIYO YUDEN for further details. k. This Product operates in the unlicensed ISM band at 2.4GHz. In case this Product is used around the other wireless devices which operate in same frequency band of this Product, there is a possibility that interference occurs between this Product and such other devices. If such interference occurs, please stop the operation of other devices or relocate this Product before using this Product or do not use this Product around the other wireless devices. l. Please evaluate adequately our module incorporated to your products before mass production. m. User Code Modification Notice. User Code for sample modules or part numbers you see in this Specification are TAIYO YUDEN standard part numbers. When any modification is made to modules to meet requested specifications, the part number will carry a different part number, due to forfeit originality. Additionally, part numbers may be modified based on mass production stage or other related stages. Please contact TAIYO YUDEN to confirm whether your part number needs to be modified. Please see the following examples for cases that part numbers are modified:
- for specific firmware version (our standard item firmware will be upgraded occasionally)
- for specific MAC address (our standard item MAC address is owned by TAIYO YUDEN )
- for other relevant cases (specific or different setting, form, sizes, or display etc..) n. In some cases, TAIYO YUDEN may use replacements as component parts of Products. Such replacement shall apply only to component part of Products, which TAIYO YUDEN deems it possible to replace or substitute according to (i) Scope provided in this Specification (e.g. Official Standard (Type Approvals etc.)) and (ii) Quality of Products. TAIYO YUDEN also ensures traceability of such replacement on production lot basis. o. Do not alter Hardware and/or Software of this Product. Please note that TAIYO YUDEN shall not be liable for any problem if it is caused by customer's alteration of Hardware or/and Software without Taiyo Yuden's prior approvals. p. Caution for Export Control This Product may be subject to governmental approvals, consents, licenses, authorizations, declarations, filings, and registrations for export or re-export of the Product, required by Japanese Foreign Exchange and Foreign Trade Law(including related laws and regulations) and/or any other countrys applicable laws or regulations related to export control. In case you will export or re-export this Product, you are strongly recommended to check and confirm, TAIYO YUDEN 4/16 WYSAAVDX7 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Control No. HD-AG-A100174 (3/4) before exporting or re-exporting, necessary procedures for export or re-export of this Product which is required by applicable laws and regulations, and if necessary, you have to obtain necessary and appropriate approvals or licenses from governmental authority at your own risk and expense. Control name General Items q. Japan Regulatory Information This product with a specific antenna is a radio system approved for Type Approval. Please follow the instructions below on designing your product. a) Please notify clearly below sentences, on your product or in the product manual. This product has a radio system which was approved as a radio station in a low power data communication system based on the Radio Law and the Telecommunication Business Law. Name of the radio system: 001WWCA1266 b) Please design your set structure in which this module can be easily attached and taken off by end users. c) This module is certified by Type Approval as the device which has SDIO Interface. Please do not use other purposes except that of certified. Please contact TAIYO YUDEN for more details of purposes of this product. d) This product is displayed the following actual indication. 2) 1) 3) 4) 5) 1) 2.4 : Represents radio equipment using the 2.4GHz band. 2) DS : Represents modulation DS-SS system. 3) OF : Represents modulation OFDM system. 4) 4 : Represents estimated interference-causing radius to premises radio stations for RFID. 5) : Indicates that the equipment can use the entire band and is capable of avoiding the band used by RFID systems. This equipment shares a frequency band with a wide range of equipment: e.g. industrial, scientific, and medical equipment such as microwave ovens, premises radio stations (radio stations requiring licenses), and specified low-power radio stations (radio stations not requiring licenses) for RFID used for rectory production lines as well as amateur radio stations (radio stations requiring licenses). 1. Before use, confirm that no premises radio stations and specified low-power radio stations for RFID or amateur radio stations operate in your vicinity. 2. In the event that this equipment causes or halt radio wave emission and contact us at the information indicated below for consultation on interference avoidance measures (e.g., partition installation). 3. Contact us if this equipment causes harmful interference to any specified low-power radio stations for RFID or amateur radio stations or if other problems arise. TAIYO YUDEN 5/16 WYSAAVDX7 Control No. HD-AG-A100174 (4/4) r. Canada Regulatory Information Control name General Items a) This device complies with Industry Canada licence-exempt RSS standards. 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative 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. L'utilisation de ce dispositif est autorise seulement aux conditions suivantes: (1) il ne doit pas produire de brouillage et (2) l'utilisateur du dispositif doit tre prt accepter tout brouillage radiolectrique reu, mme si ce brouillage est susceptible de compromettre le fonctionnement du dispositif. b) This product is certified as type of the portable device with Industry Canada in the specific host platform only. To maintain compliance with SAR requirement, please use within specification of this product. Please refer Appendix for more details. c) Please notify certified ID by either one of the following method in your product.
-Contains Transmitter module IC : 4389B-WYSAAVDX7
-Contains IC : 4389B-WYSAAVDX7 s. FCC Regulatory Information a) 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. b) Please notify certified ID by either one of the following method.
-Contains Transmitter Module FCC ID: RYYWYSAAVDX7
-Contains FCC ID: RYYWYSAAVDX7 c) CAUTION: changes or modifications not expressly approved by the party responsible for compliance could void the uses authority to operate the equipment d) This product is certified as type of the portable device with the FCC Rules in the specific host platform only. To maintain compliance with SAR requirement, please use within specification of this product. Please refer Appendix for more details. TAIYO YUDEN 6/16 WYSAAVDX7 Control No. HD-AM-A100174 (1/1) Control name Absolute maximum ratings 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Absolute maximum ratings Item Supply voltage 1 Supply voltage 2 Symbol VBAT VIO Min.
-0.3
Rating Typ. Max. 6.0 4.0 Unit Remark V V Recommendation operating range Item Supply voltage 1 Supply voltage 2 Storage temperature range Operating temperature range
(Shielding case surface temperature) Symbol VBAT VIO Tstg Topr Min. 3.4 1.62/2.97
-30
-20 Rating Typ. 5.0 1.8/3.3 25 Max. 5.5 1.98/3.63 85 80 Unit Remark V V Degrees C Degrees C TAIYO YUDEN 7/16 WYSAAVDX7 Control No. HD-AE-A100174 (1/5) Control name Electrical characteristics 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Condition Parameter DC Specifications Peak Current / Power consumption The Specification applies for Topr.= 25 degrees C, Supply voltage=Typical voltage (5.0V). RF output power = Typ. No. 1 Normal supply voltage 1 2 Normal supply voltage 2 Input Low Voltage 3 Input High Voltage 4 5 Output Low Voltage 6 Output High voltage VBAT 7 Peak Current1 VIO 8 Peak Current2 Burst Tx (150Mbps), Duty 2.4%
9 Power consumption1 Continuous Rx (150Mbps) 10 Power consumption2 Burst Tx (72.2Mbps), Duty 4.2%
Symbol VBAT VIO 1.627/2.97 VIL VIH 0.8 x VIO VOL VOH VIO - 0.4 Ip1 Ip2 Pc1 Pc2 11 Power consumption3 Min. 3.4
-0.3 Pc3
Pc4 Pc5 Pc6 Pc7 Pc8 Pc9 Pc10
12 Power consumption4 Continuous Rx (72.2Mbps) 13 Power consumption5 Burst Tx (54Mbps), Duty 25.4%
14 Power consumption6 Continuous Rx (54Mbps) 15 Power consumption7 Burst Tx (11Mbps), Duty 43.3%
16 Power consumption8 Continuous Rx (11Mbps) Power save mode
(DTIM=1, Beacon interval =100ms) Deep Sleep 17 Power consumption9 18 Power consumption10 Typ. 5.0 1.8/3.3 439 552 443 514 502 503 651 499 27 3 Max. 5.5 1.98/3.63 0.3 x VIO VIO + 0.3 0.4
30 400
Unit V V V V V V mA mA mW mW mW mW mW mW mW mW mW mW TAIYO YUDEN 8/16 WYSAAVDX7 Control No. HD-AE-A100174 (2/5) Control name Electrical characteristics 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative AC Specifications Power-on timing / External sleep clock Parameter 1 Valid Power / RESETn / Clock to PDn de-asserted 2 3 4 5 6 7 Input SLP_CLK frequency Input SLP_CLK high voltage Input SLP_CLK low voltage Input SLP_CLK phase noise requirement Input SLP_CLK slew rate limit (10-90%) Input SLP_CLK duty cycle tolerance Condition Symbol Min 300 0.8 0.0 20 Tpor Tf VIH VIL PN SR DC Typ Max 32.768 1.8
-125 1.98 0.25 100 80 Remark Unit ms KHz V V dBc/Hz @100KHz ns
<Power-on sequence>
PDn must remain asserted for minimum of Tpor after VBAT, VIO and SLP_CLK are stable. RESETn must be inactive value (asserted high) when PDn is de-asserted (high level). VBAT VIO PDn SLP_CLK
(32.768KHz) Tpor Tf External reset(RESETn), power down(PDn) Parameter Condition RESETn pulse width 1 2 1. RESETn should be asserted while VBAT, VIO and SLP_CLK are stable and PDn is de-asserted (high level). 2. PDn should be asserted while VBAT, VIO and SLP_CLK are stable and RESETn is de-asserted (high level). 3. For lowest current consumption, apply all power rails to WYSAAVDX7 during the assertion of PDn pin. PDn pulse width Trpw Tppw Symbol Min 1 300 Unit ms ms Remark Note1 Notes2, 3 Typ Max TAIYO YUDEN 9/16 WYSAAVDX7 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Control No. HD-AE-A100174 (3/5) Control name Electrical characteristics SDIO Interface Specifications The Specification applies for Topr.= -20 to TBD degrees C , Supply voltage=Typical voltage(5.0V). Parameter Symbol 1 Input SDIO_CLK Frequency 2 Input SDIO_CLK High Time 3 Input SDIO_CLK Low Time 4 Input SDIO_CMD, DATA[3:0] Setup time 5 Input SDIO_CMD, DATA[3:0] Hold time 6 Output SDIO_CMD, DATA[3:0] Delay time 7 Output SDIO_CMD, DATA[3:0] Hold time Tf Tch Tcl Tsu Thd Tod Toh Remark MHz ns 25 50
Typ Max Unit
ns ns 7.33 ns ns ns
Condition Min 0 0 10 7 10 7 5 6 5 2
2.5 Normal High Speed Normal High Speed Normal High Speed Normal High Speed Normal High Speed
High Speed Tf Tch Tcl SD_CMD SD_DATA[3:0]
SD_CMD SD_DATA[3:0]
SD_CLK HOST > WiFi WiFi > HOST Normal Mode High Speed Mode WiFi > HOST HOST > WiFi SD_CLK SD_CMD SD_DATA[3:0]
SD_CMD SD_DATA[3:0]
Tsu Thd Tod Tf Tch Tcl Tsu Thd Toh Tod TAIYO YUDEN 10/16 WYSAAVDX7 Control No. HD-AE-A100174 (4/5) Control name Electrical characteristics 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative RF Specifications (WLAN 11n/150Mbps, OFDM) The Specification applies for Ta=25 degrees C, Supply voltage =Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power Condition Typ Max Unit Remark
-66 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 RF Specifications (WLAN 11n/72.2Mbps, OFDM) The Specification applies for Ta=25 degrees C, Supply voltage =Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power SEN MIL ROS1 ROS2
-20
Condition Typ Max Unit Remark 1st Side Lobe 2nd Side Lobe 3rd Side Lobe Rms 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<10%
PER<10%
30MHz to 1GHz 1GHz to 12.75GHz 1st Side Lobe 2nd Side Lobe 3rd Side Lobe Rms 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<10%
PER<10%
30MHz to 1GHz 1GHz to 12.75GHz 3 Spectrum Mask 4 Symbol clock tolerance 5 Frequency tolerance 6 EVM 7 TX Out of band spurious1 8 TX Out of band spurious2 9 TX Out of band spurious3 3 Spectrum Mask 4 Symbol clock tolerance 5 Frequency tolerance 6 7 TX Out of band spurious1 8 TX Out of band spurious2 EVM 9 TX Out of band spurious3 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 Po M1 M2 M3 Ft Ft Symbol Min 2422 FREQ 9
-25
-25
EVM TOS1 TOS2 TOS3 Po M1 M2 M3 Ft Ft Symbol Min 2412 FREQ 9
-25
-25
EVM TOS1 TOS2 TOS3 SEN MIL ROS1 ROS2
-20
-69 11 11 2462 MHz dBm 13
-20 dBc dBc
-28 dBc
-45 25 ppm ppm 25 dB
-28 dBm
-36
-30 dBm
-47
-61
-57
-47 dBm dBm dBm dBm dBm 2472 MHz dBm 13
-20 dBc dBc
-28 dBc
-45 25 ppm ppm 25 dB
-28 dBm
-36
-30 dBm
-47
-64
-57
-47 dBm dBm dBm dBm dBm TAIYO YUDEN 11/16 WYSAAVDX7 Control No. HD-AE-A100174 (5/5) Control name Electrical characteristics 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative RF Specifications (WLAN 11g/54Mbps, OFDM) The Specification applies for Ta=25 degrees C, Supply voltage =Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power Condition Typ Max Unit Remark
-72 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 RF Specifications (WLAN 11b/11Mbps, CCK) The Specification applies for Ta=25 degrees C, Supply voltage=Typical voltage (5.0V). No. Parameter 1 RF frequency range 2 TX Power SEN MIL ROS1 ROS2
-20
Condition Typ Max Unit Remark 1st Side Lobe 2nd Side Lobe 3rd Side Lobe Rms 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<10%
PER<10%
30MHz to 1GHz 1GHz to 12.75GHz 1st Side Lobe 2nd Side Lobe Power up Power down Peak 30MHz to 1GHz 1GHz to 12.75GHz 1.8GHz to 1.9GHz 5.15GHz to 5.3GHz PER<8%
PER<8%
30MHz to 1GHz 1GHz to 12.75GHz 3 Spectrum Mask 4 Symbol clock tolerance 5 Frequency tolerance 6 EVM 7 TX Out of band spurious1 8 TX Out of band spurious2 9 TX Out of band spurious3 3 Spectrum Mask 4 Power up-down rump 5 Frequency tolerance 6 EVM 7 TX Out of band spurious1 8 TX Out of band spurious2 9 TX Out of band spurious3 10 Rx sensitivity 11 Maximum Input Level 12 RX Out of band spurious1 13 RX Out of band spurious2 Po M1 M2 M3 Ft Ft Symbol Min 2412 FREQ 10
-25
-25
EVM TOS1 TOS2 TOS3 Po M1 M2 TU TD Ft Symbol Min 2412 FREQ 13
-25
EVM TOS1 TOS2 TOS3 SEN MIL ROS1 ROS2
-10
-86 12 15 2472 MHz dBm 14
-20 dBc dBc
-28 dBc
-40 25 ppm ppm 25 dB
-25 dBm
-36
-30 dBm
-47
-65
-57
-47 dBm dBm dBm dBm dBm 2472 MHz dBm 17
-30 dBc dBc
-50 us 2 2 us ppm 25
35 dBm
-36
-30 dBm
-47
-76
-57
-47 dBm dBm dBm dBm dBm TAIYO YUDEN 12/16 WYSAAVDX7 Control No. HD-MC-A100174 (1/1) Control name Circuit Schematic Block Diagram 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative TAIYO YUDEN 13/16 WYSAAVDX7 Control No. HD-AD-A100174 (1/2) Control name Outline/Appearance 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Unit: mm, Tolerances unless otherwise specified: 0.2mm
. 5 0 5 1
. 1 2 5
. 5 7 5
0 3
0 1
. 2 0
. 1 5 0
. 0 3
. 1 4 0
. 1 2 2 5
. M a x
. 2 9
. M a x
. 1 6 5 M a x
. 1 3
. M a x
. 1 2 M a x
. 1 3 5 M a x
. 2 6
. 1 1
. 0 1
. 5 0
. TAIYO YUDEN 14/16 1) 2) 3) 7) 8) 5) 6) 11) 10) 9) 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Control name Outline/Appearance Unit: mmTolerances unless otherwise specified0.5mm WYSAAVDX7 Control No. HD-AD-A100174 (2/2) Indication label description. 4) Indication label description
: WYSAAVDX7
: RYYWYSAAVDX7 1) Model 2) FCC ID 3) Industry Canada ID : 4389B-WYSAAVDX7 4) Japan logo mark 5) Japan ID 6) User Code : WYSAAVDX7 7)ARIB,Actual indication : Indicates that this device is Second Generation Low Power Data
: 001WWCA1266
: Specified logo mark 8) Type of electrical power supply and rated voltage: Direct current mark and 5.0V Communication System 9) Manufacture : Taiyo Yuden Co., Ltd. 10) MAC address number : XXXXXXXXXXXX 11) Product Lot number : Four digits (Refer to Instruction for lot number) TAIYO YUDEN 15/16 WYSAAVDX7 Control No. HD-BA-A100174 (1/1) Control name Pin Layout 13-Nov.2013 Ver.0.9 TAIYO YUDEN Tentative Pin Descriptions Top view Terminal No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Terminal Name Input/ Output Pwr Domain Description Function GND SD_DATA1 SD_DATA0 GND SD_CLK VIO SD_CMD SD_DATA3 SD_DATA2 GND GND SLP_CLK GND PDn RESETn
Input/Output Input/Output
Input Input Input/Output Input/Output Input/Output
Input
Input Input Input/ Output GPIO16 HOST_WL_WKUP Output GND VBAT VBAT
Input Input GND VIO VIO GND VIO VIO VIO VIO VIO GND GND 1.8V GND VIO VIO VIO VIO GND VBAT VBAT Ground SDIO Data-1 SDIO Data-0 Ground SDIO Clock 1.8V/3.3V Digital I/O Power Supply SDIO Command SDIO data-3 SDIO data-2 Ground Ground Sleep Clock (32.768kHz) Used for WLAN low-power modes. Ground Power Down (active low) with internal pull-up. Reset (active low) with internal pull-up. Reserved, keep on set side terminal HOST wakeup Ground 5.0V Power Supply 5.0V Power Supply TAIYO YUDEN Power SDIO SDIO Power SDIO Power SDIO SDIO SDIO Power Power System Power System System System System Power Power Power 16/16 Appendix of WYSAAVDX7_User Manual Canada Regulatory Information 13-Nov.2013 TAIYO YUDEN Tentative This product is certified as type of the portable device with Industry Canada in the specific host platform only. To maintain compliance with SAR requirement, please use within specification of this product. Please refer the following for more details. Model. No. S4 Measured 1gSAR [mW/g] (MAX) 0.242 (Head), 0.423 (Body) Reported SAR [mW/g]
0.27 (Head), 0.47 (Body) FCC Regulatory Information This product is certified as type of the portable device with the FCC Rules in the specific host platform only. To maintain compliance with SAR requirement, please use within specification of this product. Please refer the following for more details. Model. No. S4 Measured 1gSAR [mW/g] (MAX) 0.242 (Head), 0.423 (Body) Reported SAR [mW/g]
0.27 (Head), 0.47 (Body) TAIYO YUDEN 1/1
1 2 3 | user manual (S)Ver 2 | Users Manual | 543.39 KiB |
TABLE OF CONTENTS REF 9515-TBD-50-ENG Rev E S4 12 LEAD TELEMETRY TRANSMITTER USER MANUAL Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Copyright 2013 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. S4 and VERITAS are trademarks of Mortara Instrument, Inc. All other trademarks and registered trademarks are the property of their respective owners. TABLE OF CONTENTS 1. GENERAL STATEMENTS ....................................................................................................................... 1 TECHNICALSUPPORTANDSERVICE.....................................................................................................................................1 2. NOTICES .................................................................................................................................................. 2 MANUFACTURERSRESPONSIBILITY....................................................................................................................................2 RESPONSIBILITYOFTHECUSTOMER....................................................................................................................................2 EQUIPMENTIDENTIFICATION.............................................................................................................................................2 COPYRIGHTANDTRADEMARKNOTICES...............................................................................................................................2 OTHERIMPORTANTINFORMATION.....................................................................................................................................2 3. WARRANTY INFORMATION ................................................................................................................... 3 4. USER SAFETY INFORMATION .............................................................................................................. 4 SAFETYREGULATIONS......................................................................................................................................................4 WARNINGS....................................................................................................................................................................4 Power Warnings............................................................................................................................................5 Accessories, Cables, and External Connections Warnings...................................................6 Use with Electro Surgery Devices Warnings.................................................................................6 ECG Warnings................................................................................................................................................6 CAUTIONS.....................................................................................................................................................................8 5. EQUIPMENT SYMBOLS AND MARKINGS ............................................................................................ 9 SYMBOLDELINEATION.....................................................................................................................................................9 PRECAUTIONS..............................................................................................................................................................10 INSPECTIONPRIORTOCLINICALUSE.................................................................................................................................10 CLEANING...................................................................................................................................................................11 MAINTENANCE.............................................................................................................................................................12 BATTERYLIFEANDCHARGETIME.....................................................................................................................................13 DECOMMISSIONINGANDDISPOSAL..................................................................................................................................13 7. ELECTROMAGNETIC COMPATABILITY (EMC) ................................................................................. 14 USAANDCANADARADIOREGULATIONS..........................................................................................................................18 8. INTRODUCTION ..................................................................................................................................... 19 GENERALINFORMATION................................................................................................................................................19 INDICATIONSFORUSE...................................................................................................................................................19 CONTRAINDICATIONS.....................................................................................................................................................19 SYSTEMDESCRIPTION....................................................................................................................................................20 FrontView............................................................................................................................................................20 CARRYING POUCH ................................................................................................................................... 21 TIE-ON POUCH .......................................................................................................................................... 21 STICK-ON POUCH 9. UNPACKING AND SET UP ................................................................................... 21 9. UNPACKING AND SET UP ................................................................................................................... 22 CHECKINGCONTENTS....................................................................................................................................................22 i 10. OPERATION ......................................................................................................................................... 23 TURNINGTHES4ON.....................................................................................................................................................23 CONNECTINGS4TOTHESURVEYORCENTRALSTATION........................................................................................................24 10. STARTING A MONITORING SESSION .............................................................................................. 33 TABLE OF CONTENTS 11. PATIENT PREPARATION FOR QUALITY ECG ................................................................................. 35 OVERVIEW..................................................................................................................................................................35 QUALITYECGDATAACQUISITION...................................................................................................................................35 SKINPREPARATION.......................................................................................................................................................36 ELECTRODEPLACEMENT.................................................................................................................................................36 13. PATIENT ELECTRODE HOOK UP...................................................................................................... 37 Pacemaker Patients.................................................................................................................................37 ELECTRODELOCATIONSFOR12LEADECG........................................................................................................................37 Using the LeadForm 12-lead Cable..................................................................................................39 CHECKINGECGELECTRODEANDLEADWIRESIGNALQUALITY..............................................................................................40 14. PRODUCT SPECIFICATIONS ............................................................................................................. 41 GENERALSPECIFICATIONS..............................................................................................................................................41 ENVIRONMENTALCONDITIONS........................................................................................................................................41 POWERREQUIREMENTS&BATTERY.................................................................................................................................41 DISPLAYSPECIFICATIONS................................................................................................................................................42 ECG..........................................................................................................................................................................42 15. TROUBLESHOOTING ......................................................................................................................... 44 POWERANDBATTERY....................................................................................................................................................44 DISPLAYANDTOUCHSCREEN..........................................................................................................................................44 ECGTRACE.................................................................................................................................................................44 16. ACCESSORIES .................................................................................................................................... 45
* TECHNICAL SERVICE INSTALLATION REQUIRED....................................................................................................45
** THIS ITEM IS INTENDED FOR SINGLE PATIENT USE. IT IS WARRANTED TO BE FREE OF DEFECTS IN WORKMANSHIP AND MATERIALS FOR A PERIOD OF 90 DAYS OR FIRST USE, WHICHEVER COMES FIRST...............................................45 17. APPLICABLE STANDARDS ............................................................................................................... 46 ii 414.354.1600 800.231.7437 414.354.4760 http://www.mortara.com 1. GENERAL STATEMENTS Technical Support and Service Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel:
Tel:
Fax:
Internet:
European Union Representative Mortara Rangoni Europe, Srl
(European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel:
Fax:
Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel:
Service:
Fax:
E-mail:
24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts 414.354.1600 888.MORTARA
(888.667.8272) 414.354.4760 techsupport@mortara.com
+39.051.298.7811
+39.051.613.3582
+49.201.18 55 69 70
+49.201.18 55 69 77 414.354.1600 414.354.4760 sales@mortara.com Sales Support/
Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel:
Fax:
E-mail:
Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel:
Fax:
Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel:
Fax:
Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel:
Fax:
Mortara Dolby UK Ltd. Units 11 & 12, Scion House Stirling University Innovation Park Stirling FK9 4NF Scotland Tel:
Fax:
+44.1786.444980
+44.1786.446630
+61 2 8070 9303
+61 2 9899 9478
+31.499.377310
+31.499.377908 1 2. NOTICES Manufacturers Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance of the telemetry transmitter, as indicated by the label, only if article 2 of 93/42/EEC directive is applied, in particular:
WARNING: System installation and assembly operations, extensions, readjustments, modifications or repairs are carried out by personnel authorized by Mortara Instrument, Inc. only. The telemetry transmitter is used in accordance with the instructions for use. The telemetry transmitter is correctly maintained according to the standards authorized by Mortara Instrument, Inc. using original spare parts. specifications described in this manual. The telemetry transmitter is used with original accessories and supplies that are in compliance with the standard The electrical installation of the relevant room complies with the requirements of appropriate regulations. Responsibility of the Customer The user of this telemetry transmitter is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. This manual must be kept in a safe place to prevent its deterioration and/or alteration. The user and Mortara Instrument, Inc. authorized personnel must have access to this manual at any time. The user of this telemetry transmitter must periodically check the accessories, their functionality and integrity. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the telemetry transmitter. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated into another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document. 2 3. WARRANTY INFORMATION MORTARA INSTRUMENT, INC. (hereafter referred to as Mortara) warrants that components within Mortara products (hereafter referred to as Product/s) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Mortara, or if not otherwise noted, for a period of twelve (12) months from the date of shipment. Consumable, disposable or single use products such are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions:
a) Freight damage;
b) Supplies, accessories and internal parts NOT approved by Mortara;
c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;
d) Accident;
e) A disaster affecting the Product/s;
f) Alterations and/or modifications to the Product/s not authorized by Mortara;
g) Other events outside of Mortaras reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortaras obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortaras principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASERS SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. 3 4. USER SAFETY INFORMATION Warning:
Means there is the possibility of personal injury to you or others. Caution:
Means there is the possibility of damage to the telemetry transmitter. Note:
Provides information to further assist in the use of the telemetry transmitter. NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording. Safety Regulations S4 is a medical telemetry transmitter. S4 and its accessories are S4 with all accessories that have a physical or logical connection with it, forms part of a Medical Electrical labeled, according to applicable standards. System. S4 complies with various safety and performance regulations as mentioned in this manual (Applied Standards). Warnings This manual gives important information about the use and safety of this telemetry transmitter. Deviating from operating procedures, misuse or misapplication of the telemetry transmitter, or ignoring specifications and recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the telemetry transmitter. Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this telemetry transmitter. Telemetry transmitter captures and presents data reflecting a patients physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis; however, the data should not be used as a sole means for determining a patients diagnosis. Before attempting to use this device for clinical applications, the operator must read and understand the contents of the user manual and other accompanying documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and bystanders, or damage to the telemetry transmitter. Contact Mortara Technical Service for additional training options. Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human subjects, may cause inaccurate results. To ensure the safety of both the patient and the device, 1.5 meters (5) of open area should surround the patient. A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. Do not mount any part of the device closer than 25 cm from outlets of flammable gases, including oxygen. For proper operation and the safety of users or patients and bystanders, equipment and accessories must be connected only as described in this manual. 4 Repairs and modification must be made by authorized and trained technical personnel. Unauthorized modifications and repairs will void the S4 warranty and may pose a danger to patients and users. If additional devices beyond S4 are connected to the patient, leakage currents through the patient might add up and should be accounted for. The S4, as all medical equipment or systems, needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the installation procedure in order to obtain a sufficient degree of immunity as well as not to create disturbance to other equipment. Refer to the specific EMC instructions in this manual. The quality of the signal produced by the device may be adversely affected by the use of other medical equipment, including but not limited to electrosurgery and ultrasound machines. Do not use the system in the presence of imaging equipment such as magnetic resonance imaging (MRI) and tomography systems. Simultaneous operation may damage the device or lead to erroneous results. Portable and mobile RF communications equipment may affect medical electrical equipment or systems as well as the S4 and its accessories. Do not operate the S4 near high frequency emissions (e.g. microwaves). Various alarm conditions arising at the Central Station require operator to adjust alarm configurations individualized according to patient condition and demographics. A telemetry transmitter is not intended to replace clinical assessments. It is important that a qualified individual regularly supervise the patient. Power Warnings Only use the Mortara-provided external battery charger and adapter with the S4. Ensure that the power adapter is connected to a properly grounded power terminal and the electrical installation complies with local safety requirements for the environment where it is used. To ensure that electrical safety is maintained during operation from AC power, the S4 external power adapter must be plugged into a hospital-grade outlet. Regularly check all cables for damage and proper connection. Do not use equipment with a damaged cable. The S4 contains an internal battery. The following precautions should be taken regarding the battery:
o Do not immerse the device in water. o Do not heat or throw the device in fire. o Do not leave the in conditions over 60 C or in a heated car. o Do not attempt to crush or drop the device. o Only use the approved batteries with the S4 monitor. o Follow the instructions in the disposal section of this manual when the S4 is taken out of service. The S4 battery must be initially fully charged prior to use. The S4 screen initially turns on when batteries are installed, remove the S4 from service and contact Mortara Technical Support if the screen does not activate when new or fully charged batteries are initially installed. Always remove the batteries after completing operating the telemetry transmitter. Always place rechargeable batteries in the battery charger when not in use. This ensures that the batteries are recharged for the next time the telemetry transmitter is operated. 5 Accessories, Cables, and External Connections Warnings The S4 telemetry transmitter is designed to meet applicable specifications when using Mortara-approved patient cables and accessories. Use of non-approved cables and accessories may result in reduced performance and may pose possible patient and user safety concerns. It is the users responsibility to use only approved supplies, accessories and internal parts available through Mortara Instrument, Inc. Product performance and patient safety require the use of supplies, accessories and internal parts that comply with applicable standards. To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact must be in compliance with applicable standards as appropriate to the telemetry transmitter. Additionally, cables and accessories must comply with all EMC regulations. In Europe, cables and accessories should bear the CE Mark. Only use parts and accessories supplied with the telemetry transmitter and available through Mortara Instrument, Inc. Do not use excessive force on any of the connection cables and handle all accessories with care. Proper clinical procedure must be employed to prep the electrode and sensor sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions. Electrodes and other sensors are intended for short-term use and should be removed from the patient promptly following use. Conductive parts of the ECG patient cables, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground. To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with telemetry transmitter or patient cables. Additionally, proper placement of defibrillator paddles in relation to the ECG electrodes is required to minimize harm to the patient. Mortara-approved manufacturers of accessories provide separate user manuals (e.g., patient cables, electrodes, etc.). Read these manuals thoroughly and refer to them for specific functions. It is recommended to keep all manuals together. expiration date or useful life. To maintain safety and effectiveness, ECG electrodes and reusable sensors and must not be used beyond their All accessories including cables, connectors and other patient-applied parts supplied with the S4 do NOT contain any Latex. If the patient develops an allergic reaction or rashes, immediately remove the accessory and inform Mortara Technical Support. Use with Electro Surgery Devices Warnings Do not use the S4 while ESU is actively used on a patient. The S4 may not render an ECG while an ESU is being actively used on the connected patient. ECG Warnings Excessive patient movement could interfere with the operation of the system. Proper patient preparation is important to proper application of ECG electrodes and operation of the telemetry transmitter. 6 ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation. 12-lead ECGs acquired through S4 will normally use a modified lead system with the limb electrodes positioned on the torso. Although this is a generally accepted practice (e.g., in stress testing), the different electrode positions can cause morphology changes on the ECG, thus influencing their interpretation. Most frequently seen differences are a vertical and rightward axis shift, minor changes of evidence of old inferior infarction and changes in the T-wave in the limb leads. It is recommended that you place the electrodes as close as possible to the normal limb positions avoiding the possibility of causing artifact. The right arm and left arm electrodes should be placed on the clavicles as close as possible to the arms. The left leg electrode should be placed as close as possible to the left leg without subjecting it to the possibility of motion artifact. During periods of lead fail and when a reduced lead set is used for the S4 telemetry transmitter, 12-lead ECG interpretation cannot be reliably used in determining a diagnosis. 7 Cautions back on. Cleaning must be performed with the system turned off. Let all parts dry well before turning the power Prevent liquids from penetrating the system, components, and transmitters. Do not spray the system with liquid cleaning agents. If liquids have penetrated the system, open by authorized personnel for inspection and let dry completely. Do not attempt to clean the telemetry transmitter or patient cables by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the telemetry transmitter. No user-serviceable parts inside. Screw removal by authorized service personnel only. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by authorized service personnel prior to continued use. The S4 accommodates (3) consumable or (1) rechargeable internal battery. If the battery appears to become defective, refer to Mortara Technical Support. Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. When not in use, patient cables can be stored. Keep patient cables should be stored off of the floor away from bedrails and wheels to avoid cable damage. Roll the patient cables into a loose loop prior to hanging for storage. When necessary, dispose of the telemetry transmitter, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. Do not connect the telemetry transmitter to any unauthorized third-party accessories. This may cause inaccurate measurements or harm the patient. Installation and connection to data networks must be performed by properly trained personnel, authorized by Mortara. Check that all operating and environment conditions such as ambient temperature meet the specifications of the Do not exert excessive pressure on the touch panel LCD. Excessive pressure may permanently damage the During MRI scanning, the module must be placed outside the MRI suite. S4. display. The device is ETL listed:
ETL-Listed device in the USA and Canada. Upon request, Mortara can supply a Service Manual that includes additional calibration and test instructions as well as list of spare parts and accessories that must be used with the S4 telemetry transmitter. 8 5. EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Indicates compliance to applicable European Union directives Indicates device has been tested for safety from vertically dripping water;
specifically, it indicates DRIP PROOF, a higher than ordinary level of protection from drips, leaks, and spills Caution Catalog number for relevant Mortara part SN This end up Fragile, handle with care Storage temperature range Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements Defibrillator-proof type CF applied part Consult accompanying documents Serial number Keep away from sunlight Keep dry Nurse Call (waiting for final black and white artwork) IPX4 9 6. GENERAL CARE Precautions Power off the telemetry transmitter before inspecting or cleaning. Protect the telemetry transmitter from liquids. Never immerse the telemetry transmitter in water. Do not drop the telemetry transmitter or subject to shock and/or vibration. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may damage equipment surfaces. Inspection Prior to Clinical Use Inspect your equipment prior to clinical operation. Do not use the equipment and contact an authorized service representative for servicing if there are concerns about integrity of the system. Verify that all cables and connectors are securely seated. Check the case and chassis for any visible damage. Inspect keys and controls for proper function and appearance. Check for visually well balanced screen images. Inspect patient accessories for any visual damage. Patient input connector - Verify the pins on the patient input connector are all present and are not bent or damaged in any way. The recessed area for the patient connector should be free from debris and clean. Use compressed air to remove any debris that has entered into the connector area. Display Verify there are no deep scratches or physical damage to the device display. Inspect the display bezel to ensure it is firmly adhered to the device housing. Contact Mortara technical support if the display or display bezel require replacement. Battery Door Verify the battery door can be easily removed and that the spring contacts compress and decompress with minimal force applied. Inspect the plastic door assembly for signs of excessive wear or cracking, including the door seal to prevent fluid ingress. Replace the battery door assembly if necessary. Battery Compartment Inspect the battery spring contacts and the battery door latching mechanism for signs of excessive wear. If the battery compartment has been damaged, contact Mortara technical support for assistance. Device Labeling Inspect the device labeling for signs of wear and legibility. If the labeling is no longer clear and legible, contact Mortara technical support for assistance. Warning:
Servicing of this device should only be performed by Mortara authorized service personnel. 10 Preventive Maintenance Schedule:
Maintenance to be Performed Period Notes 6 months Perform every 3 months if unit is in heavy use. Clean, disinfect and visually inspect unit Equipment needed:
Clean lint free cloth Mild detergent Luke warm water Cleaning The following section provides information on proper cleaning directions for the S4 telemetry transmitter and patient accessories. Accessories should be cleaned before they are applied to a new patient. The telemetry transmitter should be cleaned as per facility standard of care. Before cleaning, please refer to the cautions listed below. Warning:
Remove the batteries from the device before inspecting or cleaning. Do not immerse the device in water or other fluids. Do not drop the device or subject it to shock and/or vibration. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces. Clean the exterior surface of the device with a damp, soft, lint-free cloth using a solution of mild detergent diluted in water. After cleaning thoroughly dry off the device with a clean, soft cloth or paper towel. Disinfecting Warning:
Be careful not to use an excessive amount of disinfecting solution that could lead to fluid entering the device. Fluid ingress may cause irreparable damage to the internal circuitry. To disinfect the device, wipe the exterior surface with a damp, soft, lint-free cloth using a solution of 10%
Household bleach and water (Sodium Hypochlorite solution consisting of a minimum 1:500 dilution and maximum of 1:10 dilution). Dry off the device with a clean, soft cloth or a paper towel. CAUTION: Always disconnect the S4 telemetry transmitter from power source before cleaning. 11 CAUTION: Do not use harsh chemicals for cleaning. Do not use disinfectants that contain phenol as they can spot plastics. Do not steam autoclave, gas sterilize, irradiate, subject to intense vacuum, or immerse in water or cleaning solution. Be careful to avoid getting cleaning liquids into connectors or the telemetry transmitter. If this occurs, allow the telemetry transmitter to dry in warm air for 2 hours, then check to make sure all monitoring functions are working properly. CAUTION: Keep the patient accessories off of the floor. Accessories that fall on the floor should be inspected for defects, contamination, proper functionality, and cleaned or discarded according to the approved recommendations. CAUTION: The user has the responsibility to validate any deviations from the recommended method of cleaning and disinfection. Maintenance The following table shows the recommended maintenance procedures for the S4 telemetry transmitter and its accessories. The S4 telemetry transmitters should be serviced once a year by a Mortara authorized service technician. However, it is good practice to periodically ensure the telemetry transmitter is in proper working order. Perform these checks at least every 12 months by a qualified biomedical engineer or other trained service personnel. To accomplish these steps in their entirety and verify the correct operation of the system, appropriate patient simulators or other equipment may be required. Refer to the service manual for further details. Functionality Procedure Mechanical Integrity Check for cracks, abrasive edges and other signs of damage. Connect ECG leads to Patient Simulator. Verify proper heart rate at 30 and 300 bpm (+/- 2 bpm or +/- 1%). Verify 1 mV test pulse (Lead II). Verify proper respiration rate at 15 and 120 bpm (+/- 3 bpm). Procedure Approved Cleaning Agents Clean the touch screen with a soft cloth moistened with either a solution of 70%
isopropyl alcohol in distilled water or soapy water. Do not spray cleaner directly onto the touch screen. Spray the cleaner onto a lint-free cloth and then wipe the monitor. To clean the touch screen display, 1. Select the Settings sidebar button. 2. Select the Administrative menu. 3. Select the Screen Cleaning mode. This action disables the monitors touch screen for 15 seconds for cleaning purposes. After the 15 seconds expires, the touch screen controls are reactivated. ECG / Respiration Functionality Touch screen Display 12 ECG Cables Approved Cleaning Agents Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US) Distilled water Disinfectant solution (such as CIDEX OPA, or a 10% solution of household bleach
(5.25% sodium hypochlorite) in distilled water) Soft, lint-free cloths and/or soft-bristled brushes Protective gloves and eyewear Procedure 1. Disconnect the telemetry transmitter from its power source. 2. Put on gloves and protective eyewear. 3. Prepare the enzymatic detergent according to the manufacturer's instructions, and also the disinfectant solution, in separate containers. 4. Apply detergent to product using a soft, lint-free cloth. If material is dried on, allow to sit for 1 minute. Do not immerse cable ends or lead wires in liquid as it can cause corrosion. 5. Wipe smooth surfaces with the cloth. 6. Use a soft-bristle brush on visibly soiled areas and irregular surfaces. 7. Remove detergent from product using cloth dampened in distilled water. 8. Repeat as necessary. 9. Apply disinfectant solution on affected area using a soft cloth. Allow product to sit for 5 minutes. 10. Wipe excess solution and clean product again with cloth dampened in distilled water. 11. Allow 2 hours for drying. Battery Life and Charge Time Battery Life hours. 1. With a new, fully charged rechargeable battery pack installed, the device shall operate for a minimum of 32 2. When a fresh set of single-use alkaline (3) batteries are installed, the device shall operate for a minimum of 12 hours. CAUTION: The battery should be removed from the telemetry transmitter completing each clinical use. The battery may need to be replaced if it is no longer holding a charge. WARNING: Use only APPROVED BATTERIES as listed in the Accessories section. Use of unapproved batteries may cause a hazard and will void the warranty. CAUTION: Batteries should only be replaced by a trained user. Decommissioning and Disposal Dispose of the telemetry transmitter, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. Do NOT incinerate or throw the battery in garbage. 13 7. ELECTROMAGNETIC COMPATABILITY (EMC) When using the telemetry transmitter, assess the electromagnetic environment affected by surrounding devices. An electronic device may either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the telemetry transmitter according to the applicable international standards. The telemetry transmitter should not be used adjacent to or stacked with other equipment. If the telemetry transmitter is used in this manner, verify the telemetry transmitter operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment may affect the performance of medical equipment. See Table X-4 for recommended separation distances between the radio equipment and the telemetry transmitter. The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the equipment. 14 Table X-1 Guidance and Manufacturers Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/
Flicker Emissions IEC 61000-3-3 Compliance Electromagnetic Environment: Guidance The S4 telemetry transmitter uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment. The S4 telemetry transmitter is suitable for use in all establishments other than domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. Group 1 Class A Not Applicable Not Applicable Table X-2 Guidance and Manufacturers Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance Electrostatic discharge (ESD) EN 61000-4-2 Electrical fast transient/burst EN 61000-4-4 Surge IEC 61000-4-5 Voltage fluctuations and Interruptions Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
+/- 1 kV differential mode
+/- 2 kV common mode
<5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles
<5% UT for 5s 3 A/m
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
+/- 1 kV differential mode
+/- 2 kV common mode
<5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles
<5% UT for 5s 3 A/m Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Note that monitoring is interrupted at the level < 5% UT for 5s, but equipment remains safe (as specified in EN 60601-1-2). Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the AC Mains voltage prior to application of the test level. 15 Table X-3 Guidance and Manufacturers Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance Conducted RF EN 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 80 MHz to 800 MHz Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 d = 1.2 d = 2.3 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
800 MHz to 2.5 GHz a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m. 16 Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m) 0.01 0.1 1 10 100 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 d = 1.2 d = 2.3 0.12 m 0.38 m 1.2 m 3.8 m 12.0 m 0.12 m 0.38 m 1.2 m 3.8 m 12.0 m 0.23 m 0.73 m 2.3 m 7.3 m 23.0 m For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 17 USA and Canada Radio Regulations USA (FCC) This device is equipped with Transmitter Module with FCC ID:RYYWYSAAVDX7 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.
[Caution] Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This device with transmitter module has been tested to SAR and complies to FCC exposure requirements for portable devices. SAR testing has been done at a distance of 10mm from the face and 0mm from the body. Canada (IC) This device is equipped with Transmitter Module with IC:4389B-WYSAAVDX7. This device complies with Industry Canada license-exempt RSS standard(s). 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."
This device with transmitter module has been tested to SAR and complies to IC exposure requirements for portable devices. SAR testing has been done at a distance of 10mm from the face and 0mm from the body.
(French) Cet appareil est quip d'un module metteur avec marque IC:4389B-WYSAAVDX7 Lappareil 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'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Cet appareil avec module metteur a t test pour les taux d'absorption spcifique (DAS) et est conforme aux normes d'exposition d'IC pour les appareils portables. Tests de DAS ont t raliss une distance de 10mm du visage et du corps 0mm. This device is defibrillator protected in compliance with AAMI standards and IEC 60601-2-25. 18 8. INTRODUCTION General Information This User's Guide provides information for users of the Mortara S4 telemetry transmitter. It is written for clinical professionals who are expected to have a working knowledge of medical procedures and terminology as required for monitoring cardiac patients. The S4 telemetry transmitter is a small, lightweight telemetry transmitters designed to acquire an ECG and to transmit this data to the Surveyor Central Monitoring station. The S4 digital ambulatory transmitter user manual explains how to:
Acquire and transmit ECG and Impedance respiration signals to the Surveyor Central Station Setup device configurations NOTE: This manual may contain renderings of various display screens. Any screen images are provided for reference only and are not intended to convey actual operating techniques. Indications For Use The S4 telemetry transmitter is indicated for use in adult & pediatric patient populations. The Mortara S4 telemetry transmitter facilitate the monitoring of ECG monitoring and Impedance respiration. The S4 telemetry transmitter is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility. The S4 telemetry transmitter is indicated for use in a clinical setting by a physician, or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The S4 telemetry transmitter is indicated for use to acquire and output electrocardiographic data. Indicated for use as a radiofrequency physiological signal transmitter, receiving and delivering real-time acquisition and RF transmission of simultaneous 12-lead ECG data, while allowing the patient to be ambulatory within the range of the antenna network. Contraindications The S4 telemetry transmitter is not intended to be used as a vital signs physiological monitor. The S4 may not render and ECG while an ESU is being actively used on the connected patient. 19 System Description The S4 telemetry transmitter represents wireless electrocardiographic technology. It provides a means to acquire and transmit simultaneous 12-lead ECG data, with diagnostic quality to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the antenna network. The S4 uses a three (3) AA alkaline batteries or (1) rechargeable battery pack. The rechargeable battery may only be charged by the Surveyor Battery Charger. The following equipment is necessary to use the S4 telemetry transmitter:
Front View S4 Telemetry transmitter: Front View Example One (1) Rechargeable Li-Ion Battery Pack or three (3) AA batteries Surveyor Central Station Monitoring System Applicable Patient Cable, lead wires and electrodes Antenna network 1. Speaker 2. Main Screen Display Area 3. Control Button Side View showing battery door 20 Carrying Pouch The S4 may be worn by the patient in the disposable pouch that is tied to the patient. The pouch is designed to fit the contours of the telemetry pack. The transparent film allows viewing of the screen and operation of the nurse call button. Tie-on Pouch The S4 may be worn by the patient in the disposable pouch that is adhered to the patients clothing. This single patient use device is fully biocompatible, with adhesive designed for attachment to a variety of surfaces and clothing. The pouch is designed to fit the contours of the telemetry pack. The transparent film allows viewing of the screen and operation of the nurse call button. Stick-On Pouch 21 9. UNPACKING AND SET UP Checking Contents Depending on the exact configuration ordered, your system may include the following components:
S4 Transmitter complete with configured Surveyor ECG Acquisition Module (SAM) and a detachable battery door. ECG cables available with the SAM module o 12 lead cable ECG electrodes available use with the S4 Transmitter o Box of 10 electrodes o Case of 100 electrodes Power Pack and Charging Options Pouch Options o Disposable Tie-On Pouch (Qty 5 included) o Disposable Stick-On Pouch (Qty 5 included) Alkaline Battery Convenience Tray o One (1) Li-Ion Rechargeable Battery Pack o Three (3) Alkaline AA batteries (not included) o Five Bay Multiple Battery Charger Kit, with Li-Ion Rechargeable Battery Pack o Reusable Battery Tray. Qty 1 included. This plastic mount conveniently loads three alkaline AA batteries into the battery compartment. Battery Tray not essential for alkaline battery installation. Battery Installation The battery compartment is accessible via the removable battery door. 1. Remove the Battery Door by pinching the grips located on each side of the door and remove. 2. Load the battery into the battery compartment:
a. Insert the rechargeable Li-Ion battery into the battery compartment. Align the battery above the contacts in the compartment. Then slide the battery down to lock it mechanically in place as it makes electrical contact. This pack fits in one way. A new Li-Ion Battery will last approximately 32 hours on a full charge. Only recharge using Mortara model CML5 Multiple battery charger. OR 22 b. Insert three (3) AA alkaline batteries into the battery compartment using the convenience tray. Align the tray for easy insertion. The batteries can also be loaded without the tray by aligning them with the positive
(+) and negative (-) indicators on the battery matching the same designators in the battery compartment. 4. Replace the battery door. Position the hinged corners first, then rock the lid down until it battery door locks snap the grips into place. 10. OPERATION Turning the S4 On The S4 will power up after either the rechargeable battery pack, or the last alkaline battery, is inserted into the battery compartment. Setting the Passcode When powered ON, the S4 will display the SETTINGS screen. o Press the Reset Passcode touch-key. o Enter a three digit Passcode using the keypad, and SAVE. o Exit the SETTINGS screen. Turning the S4 Off Power OFF the S4 by removing the internal battery. Use the Shut Down touch-key located in the Utility Screen. 23 Resume Operation After Shutdown Pressing the Nurse Call button to enter the Resume Operation screen. Pressing the [CANCEL] touch-key will cancel the Nurse Call signal destined for the central station, and instead enter the HOOK-UP screen. station and the display will dim to black. Not pressing the [CANCEL] touch-key within 20 seconds will transmit the Nurse Call signal to the central Entering a Passcode Power the S4 ON by loading the battery or by resuming operation (see above). The LED indicators will flash. Within a few seconds the HOOK-UP screen will appear. Pressing the TOOLBOX touch-key will enter the Unlock Screen. This screen is displayed whenever the operator tries to perform a protected action such as entering in the Utility screen before unlocking S4 with the correct Passcode. Enter the correct (preset) passcode using the keypad. Then press OK or one of the following touch-keys:
o OK (will verify the entered code against the preset valid passcode) o CL (will clear the entered code) o CANCEL (will cancel the requested action) Connecting S4 to the Surveyor Central Station Connection of the S4 transmitter to the Surveyor Central Station is automatic on power ON of the S4. The LED located below the WIFI icon indicates that the S4 is connected to the central station when the LED is illuminated, and flashes when the S4 is searching for WiFi connection. NOTE: Refer to the service manual for further details on central station networking. 24 The S4 contains a touch screen user interface for operator interaction. The operator can recognize when definitively pressing the on-screen touch-keys, screens and Nurse Call button, by an audible sound from the S4 speaker. A list of touch-keys, buttons, icons and indicators and their functionality follows. Icon Touch-keys and Screens PATIENT HOOK-UP Press this touch-key icon to enter the hookup screen. The HOOK-UP screen allows the operator to visualize the ensure quality electrode connection and proper location placement. Note the effectiveness of the patient electrode and lead wire interface connection by the color of the dot indicators on the screen torso. The Hook-Up Screen Pressing the Torso image will display the Patient Information Screen (if a patient record is associated to the configured monitoring slot on the central station). The HOOK-UP screen displays patient demographics information if available from the central station. The operator may configure the page header to display either the patient ID or the Patient Name. The accessible touch-keys available from the HOOK-UP screen are:
o o o ECG (displays streaming ECG waves) TOOLBOX (tools for adjusting ECG waveform, other utilities) START (starts an active session) NOTE: The START touch-key begins the monitoring session if the S4 finds connection to the central station, otherwise the START touch-key will be grey (disabled). 25 ECG WAVEFORM Press this touch-key icon to enter the ECG Waveforms Screen. ECG touch-key icon Pressing the ECG touch-key displays the patients real time streaming ECG waveforms and information. ECG WAVEFORM SCREEN The ECG Waveforms Screen Touching the ECG WAVEFORM screen toggles through the displayed lead set choices:
o LA-RA, LL-RA/LL-LA, V1-RA/LA,.., V6-RA/LA (8 leads);
o LA-RA, LL-RA/LL-LA, V1-RA/LA, V2-RA/LA o V3-RA/LA, V4-RA/LA, V5-RA/LA, V6-RA/LA NOTE: Precordial lead labels will depend on the current reference lead. The touch-keys available to the operator in the ECG WAVEFORM screen include:
o HOOK-UP (visualize quality electrode connection) o PRINT (Print to the central station printer; disabled if not actively monitoring) o START (begin a monitoring session; disabled if not connected to central station) o NUMBERS (display parameters if a monitoring session is currently in progress) 26 UNLOCK THE S4 WITH PASSCODE This icon appears when the S4 is LOCKED. o o The S4 is locked so the patient cant enter the operator screen. The operator needs to UNLOCK the S4 prior to making any changes to the S4. To unlock the S4:
Press the TOOLBOX touch-key (with the S4 locked) to open the UNLOCK Screen. Enter the valid Passcode into the numeric touchpad and press OK. This icon appears after the S4 is UNLOCKED with the valid Passcode. TOOLBOX Pressing the TOOLBOX icon (with the S4 unlocked) enters the Utility Screen. The Utility Screen provides access to various functions. This screen is displayed whenever the operator tries to perform a protected user function. Once the correct Passcode is entered, functions can be completed by the operator from the UTILITY screen. The UTILITY Screen provides submenus for navigation and to select the desired ECG waveform setting. o GAIN (allows adjustment of the ECG gain) o SPEED (allows adjustment of the ECG waveform speed) o SETTINGS (allows Configuration of the S4) o HOOK-UP (returns to the Hookup screen) o SHUTDOWN (powers OFF the S4 transmitter) 27 SAME PATIENT SAME PATIENT Pressing the SAME PATIENT touch-key identifies the demographics for the previous patient and returns to the HOOK-UP screen, for confirmation of quality electrode connection and proper lead placement. NEW PATIENT NEW PATIENT Pressing the NEW PATIENT touch-key starts a blind session, and returns to the HOOK-UP screen, for confirmation of quality electrode connection and proper lead placement. START START touch-key icon Pressing this touch-key begins the newly prepared patients session. NUMBERS NUMBERS touch-key icon Pressing the NUMBERS key during an active session displays the Heart Rate value returned by the central station. 28 BATERY INDICATOR PRINT RESPIRATION PRINT touch-key icon Pressing the PRINT touch-key sends a print request to the central station during an active session. This key is disabled if the monitoring session is suspended. BATTERY indicator This icon changes to indicate the current approximate energy charge remaining on the S4 battery. RESPIRATION icon touch-key Pressing the RESPIRATION touch-key displays the respiration reported to the central station. SETTINGS Screen (authorized personnel only) SETTINGS icon touch-key The SETTINGS screen provides a means to:
o Configure S4s transmission functionality for use with the central station (qualified IT specialist) o Set the user language (authorized key operator) o Reset the password (authorized key operator) o Reset screen calibration (authorized key operator) o Display version information (authorized key operator) 29 SETTINGS should be addressed by technically qualified and authorized personnel. Reconfiguration cannot be updated while in monitoring session. The various subpages are accessible from the SETTINGS screen:
o HOST (qualified IT specialist configures Central Station connectivity settings) o NETWORK (qualified IT specialist enters the network and WLAN settings) o LANGUAGE (key operator selects the user interface language) o WW-FI DIAGNOSTICS (qualified IT specialist access to current wi-fi settings and information) o RESET PASSCODE (key operator enters new Passcode) o RESET CALIBRATION (key operator chooses power up in Screen Calibration mode) o VERSION (displays the hardware and software versions for the transmitter) o SAM VERSION (displays the hardware and software versions for the SAM) Nurse Call Button, Speaker, and LED Indicators NURSE CALL for the patient NURSE CALL push-button During an active session this button acts as a conventional NURSE CALL button, sending a signal to the attendant at the central station. When a session is not in progress, the NURSE CALL button turns OFF the Surveyor S4. POWER ON/OFF LED Power ON/OFF Indicator Label The LED below this icon indicates that the S4 is powered ON when the LED is illuminated, powered OFF when the LED is not illuminated, and flashes while waiting for passcode entry. 30 WIFI LED WIFI Bezel Icon The LED located below this icon indicates that the S4 is connected to the central station when the LED is illuminated, and flashes when not connected and searching for WiFi connection. SPEAKER ICON Speaker Icon The S4 speaker located beneath this icon provides the audible sound associated with the recognition of a screen touch-key or the Nurse Call button. 31 Patient Information, Status and Messages The S4 displays information and status messages in the top area of the display. These messages provide timely S4 information to the operator. Changing color message banners provide for easy recognition by the operator. The operator may choose to display either the Patient ID or the Patient Name (Last, First) on the display header. This selection is made when the Hookup Screen is active and the operator selects the patient or indicates the start of a BLIND session, with no patient demographics associated with a central station slot. o A conflict notification message will appear if the central station monitoring slot allocated to this S4, is currently monitored by another S4. If a conflict between two S4s should occur the operator would either:
o a) Update his particular S4 device configuration b) Shutdown his S4 c) Shut down the other S4. o To change the configuration, a key operator press the SETTINGS touch-key to access the Configuration screen. Several icons indicate the status of the S4 systems, transmission and session, as follows:
o PADLOCK (locked or unlocked, indicates if the correct passcode has been entered) o WIFI (indicates the transmitters radio signal transmission quality) o BATTERY (indicates the current battery charge) o TIME (format in Hours: Minutes: Seconds) o SLOT NAME (monitoring slot name reported to the Central Station, if connected) o STATUS (current session status: DISCHARGED, SUSPENDED, MONITORING) Patient Information is displayed when the transmitter is connected to the central station. The color banner will appear in RED when the S4 is not connected to the central station, with a message Trying to connect to Central. The S4 will continuously try to connect to the central station as it continues to display the current time. 32 10. STARTING A MONITORING SESSION Starting a Monitoring Session 1. Insert the battery into the S4 to turn ON the device. 2. Press the touch-key to enter the UNLOCK Screen. 3. Enter the Passcode to unlock the S4 device. 4. Press the touch-key. Attach the electrodes and lead wires to the patient. screens Torso image, visualize the proper electrode placement locations and NOTE: Using the attach electrodes and lead wires to the patient to achieve all green indications, to assure a high quality signal. 5. Press the touch-key to enter the Start Session screen. NOTE: The Start Session screen allows the operator to start a monitoring session. The top of the screen will display the Information Header. A dropdown menu will be populated with the list of profiles currently available on the central station. 6. Select the patient o Press the SAME touch-key to restart the previous monitoring session preserving the patient record last associated with the monitoring slot. The touch-key is grey (disabled) if there is no patient record associated with that central station slot. Or o Press the NEW touch-key to start a new monitoring session where no patient demographics yet entered (blind session). The session will use the profile currently selected in the dropdown menu. 7. To end a session, first activate the S4 operation capability:
a) b) button to activate the screen. Press the Press the [ABORT] touch-key within 20 seconds, to cancel the Nurse Call signal and resume operation of the S4 device. 33 8. Press the touch-key to access the Utility Screen. 9. Press the touch-key and confirm (OK) shutdown. NOTE: The SHUTDOWN command will turn OFF the S4 device and suspend the active monitoring session. Choose Cancel to re-open the HOOK-UP screen, or OK to power down and suspension (end) the monitoring session. NOTE: Shutting down the S4 during an active session with an identified patient will end (suspend) the session and will save the monitored data. CAUTION: Shutting down the S4 during an active blind session will end the session and will not save the monitored data. 34 11. PATIENT PREPARATION FOR QUALITY ECG Overview Quality ECG Data Acquisition The ECG electrodes sense the electrical signals generated by the electrical activity of the heart as it beats. The S4 transmitter amplifies the signals so they can be displayed on the screen. The S4 transmitter is configured to a specific Surveyor Acquisition Module (SAM) and appropriate ECG cable. The 12-Lead SAM uses the LeadForm 12 lead ECG cable. Obtaining quality ECG data is important in continuous ECG monitoring. A quality ECG signal depends largely on the patient prep and electrode placement. Direct contact between the electrodes and the patient's skin and correct placement of the electrode can help ensure obtaining quality ECG data. A good quality ECG contains:
Discernible P waves, QRS complexes, and T waves. Good R wave detection. Steady, even, crisp baseline. Absent of respiratory variability, artifact, noise, and other interference. A good quality ECG may enhance the performance of the arrhythmia algorithm and may lessen false erroneous alarm notifications. A poor quality ECG may be caused by many factors:
Poor site preparation may lead to poor quality ECG data. Poor electrode application may lead to poor quality ECG data. Patient movement may lead to poor quality ECG data. Poor quality ECG becomes synonymous with artifact and interference in the ECG waveforms. Interference by other equipment in the room may lead to poor quality ECG data. A poor quality ECG may manifest in several ways:
Superfluous baseline artifact. Erratic baseline. Sharp spikes. Rolling, wandering waveforms as seen with patient breathing patterns. Difficult to discern P waves from atrial fib waves from noise. Poor R wave detection. Inability to discern P waves, QRS complexes, T waves. Artifact and interference in the ECG waveforms may be caused by using accessories, lead wires, and ECG cables other than those specified to work with the S4 telemetry transmitters. Always use accessories, lead wires, ECG cables, and other accessories specified to work with the S4 telemetry transmitters. 35 Skin Preparation In continuous ECG monitoring, the goal of skin preparation is to maximize the surface area of direct contact between the patients skin and the ECG electrode. Follow the facilitys standard of care when preparing the patients skin for ECG electrode placement and ECG monitoring. To prepare the patients skin for electrode placement:
1. Explain the procedure to the patient. 2. Maintain patient privacy during skin prep and electrode placement. 3. Locate the correct anatomical landmarks for electrode placement. 4. Clip or shave excess hair in the areas marked for electrode placement. 5. Remove residual skin oils, creams, and lotions by gently abrading the skin with a small gauze pad. NOTE: With elderly or frail patients take care to not abrade the skin causing discomfort or bruising. Clinical discretion should always be used in patient preparation. Electrode Placement To apply electrodes:
1. Use pre-gelled, Ag/AgCl disposable electrodes. a. Do not use electrodes after their expiration date, or if the gel has dried out.
Store electrodes in an air tight container.
Electrodes dry out if not stored properly leading to loss of adhesion and conductivity. b. Always use the same electrodes.
Do not mix electrode brands or types.
Using different types of electrodes may cause a fluctuation in the impedance and this can lead to baseline artifact and noise in the ECG tracing. 2. Apply the electrodes in the following manner:
a. Attach the electrode to the ECG lead wires prior to attaching the electrode to the patients chest. b. Place the electrode in the properly prepared, correct location by using a circular motion on the c. Gently press the electrode adhesive to the patients skin until the entire outer surface of the electrode is electrode adhesive area. adhered to the patients chest. d. Once the electrode adhesive is attached, gently press on the gel area to ensure proper gel to chest contact. Avoid dislodging the gel as the displaced gel can increase baseline artifact and noise in the ECG tracing. e. Test for firm electrode contact by slightly tugging on the electrode to check for adhesion among the entire electrode surface. If the electrode moves freely, change the electrode. If the electrode does not move easily, a good adhesive contact has been obtained. Refer to the Electrode Location section in this manual for further details on correct anatomical landmarks for electrode placement. Best Practice Recommendation: Change electrodes as per hospital standard of care, or at least every 24 hours to enhance patient skin care and the acquisition of quality ECG data. Clinical discretion should always be used in patient preparation. 36 13. PATIENT ELECTRODE HOOK UP Pacemaker Patients Pacemaker patients may require a modified electrode placement based on the physical location of the patients pacemaker generator device. Do not place an ECG electrode directly over the pacemaker generator as this may lead to artifact and noise on the ECG tracings. The S4 will reject pacemaker spikes shorter than 300 s. The S4s integrated acquisition module will detect and report pacemaker spikes up to 2 ms width and amplitudes specified to meet the appropriate IEC standard. Spikes markers will be placed on the sample where the spike is detected. Electrode Locations for 12 Lead ECG The S4 telemetry transmitter must be configured with the 12 Lead Surveyor Acquisition Module (SAM) and the 12-lead LeadForm ECG cable set. The LeadForm patient cable consists of lead wires and connector block that connects to the 12-Lead SAM module attached to the S4 telemetry pack. Each lead wire terminates in a snap connector. Before attaching electrodes, review the next section Quality ECG Data Acquisition regarding skin preparation and electrode placement. Attach electrodes per these recommendations. The lead wires are positioned on the main cable to follow the contour of the torso. Insert the ECG connector into the input connector on the 12 Lead SAM of the S4 telemetry pack. 37 38 Using the LeadForm 12-lead Cable The 12 Lead SAM may be used for continuous simultaneous monitoring of 12 vectors of ECG. Arrhythmia and ST analysis on all 12 ECG leads may be performed by the telemetry transmitter when the AM12 is in use. Refer to the Arrhythmia and ST sections in this manual for further details. The following diagram describes the recommended electrode placement for using the AM12 in a continuous monitoring mode. Figure X: Electrode Locations: Continuous 12-Lead Monitoring IEC R (red) L (yellow) N (black) F (green) C1 (white) C2 (yellow) C3 (green) C4 (brown) C5 (black) C6 (purple) AHA RA (white) LA (black) RL (green) LL (red) V1 (brown) V2 (yellow) V3 (green) V4 (blue) V5 (orange) V6 (purple) Lead Placement Just below the right clavicle. Just below the left clavicle. Lower right edge of the rib cage. Lower left edge of the rib cage. 4th intercostal space, right sternal border. 4th intercostal space, left sternal border. Midway between C2/V2 and C4/V4. 5th intercostal space, mid-clavicular line. Left anterior axillary line at C4/V4 level. Mid-axillary line at C4/V4 and C5/V5 levels. For accurate V-lead placement and monitoring, it is important to locate the 4th intercostal space. The 4th intercostal space is determined by first locating the 1st intercostal space. Because patients vary with respect to body shape, it may be difficult to palpate the 1st intercostal space with accuracy. Thus, locate the 2nd intercostal space by first palpating the little bony prominence called the Angle of Lewis, where the body of the sternum joins the manubrium. This rise in the sternum identifies where the second rib is attached, and the space just below it is the 2nd intercostal space. Palpate and count down the chest until the 4th intercostal space is located. 39 Checking ECG Electrode and Lead Wire Signal Quality Once the patient has been properly prepared, the electrodes attached and in the correct anatomical location, the patient ECG cable is connected to the S4 the ECG Display screen display should display the ECG tracing. Check to ensure the ECG tracing is free of artifact and noise with a clean ECG baseline as per patient condition permits. If the ECG contains artifact or noise, return to the Hook Up Screen to view lead interface quality and review the steps for proper electrode site preparation and placement. 40 14. PRODUCT SPECIFICATIONS General Specifications Feature Instrument Type Input Channels Specifications 12-lead ECG digital transmitter Continuous 12-lead signal acquisition and transmission ECG Leads Transmitted I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6 Frequency Range Special Functions Defibrillator Protection 2400.96 MHz to 2482.56 MHz Lead impedance check, ECG display, lead fail, battery notification, multi-purpose call;
10-wire, Complies with AAMI standards and IEC 60601-2-25 Function Keys Control button; touch screen menu navigation; Internal speaker and microphone Environmental Conditions Temperature Humidity Altitude Cooling Weight Dimensions Operating temperature:
Storage temperature:
+0 to +40 C (+32 to +104 F)
-20 to +60 C (-4 to +140 F) Operating humidity:
Storage humidity:
15% to 90% RH, non-condensing 15% to 95% RH, non-condensing 0 to 4572 m (0 to 15,000) 0 to 12192 m (0 to 40,000) Operating:
Storage:
Convection (no fan) TBD without battery 5.5 x 3.25 x 1.34 (14 x 8.23 x 3.4 mm) Power Requirements & Battery Device Classification Type CF, battery operated Disposable Battery Type Alkaline (3) Batteries Required Disposable Battery Life 12 Hours minimum Rechargeable Battery Type Lithium-Ion technology Rechargeable (1) Battery Pack Required Rechargeable Battery Life 32 Hours minimum Battery Charging Time TBD 41 Display Specifications Type High definition, antiglare Color TFT-LCD with LED backlight and resistive touch panel controls Size & Resolution 4 inches diagonal; active area; TBD pixels ECG ECG 12-Lead ECG with specific Surveyor Acquisition Module (SAM) Simultaneous Leads Available 12 Lead SAM:
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Acquisition Rate:
Resolution:
Dynamic Range ECG Gain Trace Speed CMRR:
Pacemaker Spikes 500 samples/sec. 1.17V 300mV
(5 mV) 10 mV, 20 mV, 40 mV
(5 mm/sec), 10 mm/sec, 25 mm/sec According to applicable specifications Reject pacemaker spikes shorter than 300 s. Detect and report pacemaker spikes up to 2 ms width and amplitudes Spikes markers will be placed on the sample where the spike is detected Max. Auxiliary Patient Current: < 10 A Frequency Response Filtering:
S4 Screen: 0.67 to 40 Hz Diagnostic at the Central Station: 0.05 to 150 Hz Input Impedance:
Electrodes:
Beat Detection:
Beat Recognition:
HR Averaging
>2.5 MOhm at 10 Hz Must be compatible with EN 60601-2-27 Sensitivity 99.90%, positive predictivity 99.88% (AHA/MIT database) Normal, Ventricular, Paced, Unknown The algorithm calculates the heart rate from its available source. If the heart rate from the last four R to R intervals is greater than 48 beats per minute, the average heart rate is determined by averaging the last 16 R to R intervals. If the heart rate from the last four R to R intervals is less than or equal to 48 beats per minute, then this rate is used. Paced beats and PVCs are included in the heart rate calculation. HR Range:
HR Resolution HR Availability:
15 to 300 bpm, Adult and Pediatric 1 beat per minute Within TBD seconds after appearance of traces HR Measurement Accuracy Measurement error (RMS) as measured according to ANSI/AAMI EC57: 2.8% AHA 42 database, 1.7% MIT database HR Report from the central station Less than one second. Heart rate is only available when the S4 is connected to the central station. Minimum QRS Amplitude:
300V Recovery from Defibrillation Discharge The worst case device reset and ECG recovery scenario will last less than 5 seconds. During device recovery a sequence of calibration samples (marked as such) will be generated and delivered to the central station and S4 display. 43 15. TROUBLESHOOTING The following table provides guidance for investigating issues that may occur during operation of the S4 telemetry transmitters. Contact Mortara Technical Service at 1-866-MORTARA for further assistance. Power and Battery Symptom Possible Causes Suggested Resolution The S4 telemetry transmitter is not working and display does not light up. Internal system failure Battery will not hold charge Display and Touch Screen Power cycle the S4 telemetry transmitter with fresh batteries and try again. If problems persist, stop using the S4 telemetry transmitter and contact Mortara Technical Support. Replace the battery according to instructions in the General Care & Maintenance section. Symptom Possible Causes Suggested Resolution The touch screen is not working properly. Touch screen failure The display is not working properly. Display failure Power cycle the S4 telemetry transmitter and try again. If problems persist, stop using the S4 telemetry transmitter and contact Mortara Technical Support. Power cycle the S4 telemetry transmitter and try again. If problems persist, stop using the S4 telemetry transmitter and contact Mortara Technical Support. ECG Trace Symptom Possible Causes Suggested Resolution Patient movement Confirm electrode site preparation; confirm correct ECG placement; instruct the patient to not move. Calm the patient. ECG signal is noisy. Electrical noise from auxiliary equipment Isolate the patient from auxiliary equipment, if possible. Bad electrode contact Check to make sure electrodes are still securely attached to the patient, and reattach if necessary. Remember the importance of good skin preparation techniques. 44 16. ACCESSORIES Use the following Mortara part numbers to obtain spare parts or to reorder accessories:
Part Numbers Description S4 SAM 12 LEAD WIRE ACQUISITION MODULE *
S4 BATTERY DOOR LI-ION BATTERY PACK TIE-ON DISPOSABLE POUCH - BOX 100**
STICK-ON DISPOSABLE POUCH - BOX 100**
PAT CBL 10WIRE LEADFORM AHA SNAP**
PAT CBL 10WIRE IEC SNAP CINCH**
PAT CBL 10WIRE LEADFORM XL AHA SNAP**
PAT CBL 10WIRE LEADFORM XL AHA SNAP**
HOOKUP KIT MONITORING 10E SINGLE**
S4 USER MANUAL KIT, CHARGER, LI-ION-5, US/CAN KIT, CHARGER, LI-ION-5, INTN'L KIT, CHARGER, LI-ION-5, AUSTRALIA KIT, CHARGER, LI-ION-5, UK AC POWER SUPPLY, FOR CHARGER KIT CONVENIENCE TRAY, FOR AA ALKALINE BATTERIES Part Numbers 76190-002-50 76190-002-70 4800-018 8485-029-51 8485-030-51 9293-017-50 9293-017-51 9293-026-50 9293-026-51 9294-009-50 9515-TBD-50-CD 41000-035-01 41000-035-02 41000-035-03 41000-035-04 4101-012 8364-005-50
* Technical Service Installation Required
** This item is intended for single patient use. It is warranted to be free of defects in workmanship and materials for a period of 90 days or first use, whichever comes first. To order additional supplies, contact a Mortara Instrument customer service representative. 45 17. APPLICABLE STANDARDS APPLIED STANDARDS IEC 60601-1:2012-08 Edition 3.1, Medical Electrical Equipment. Part 1: General Requirements for basic safety and essential performance. IEC 60601-1-2:2007-03 Edition 3.0, Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility Requirements and tests. IEC 60601-1-6:2010-01 Edition 3.0, Medical Electrical Equipment Part 1-6: General Requirements for Safety and Essential Performance Collateral Standard: Usability. IEC 60601-1-8:2012-1 Edition 2.1, Medical Electrical Equipment Part 1-8: General Requirements for Safety and Essential Performance Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems . (Note: when used in conjunction with the Surveyor Central Station) IEC 60601-2-25:2011-10 Edition 2.0, Medical Electrical Equipment. Part 2-25: Particular requirements for the basic safety and essential requirements of electrocardiographs.
(Notes: Applies to 10-wire acquisition module only; when used in conjunction with the Surveyor Central Station)) IEC 60601-2-27:2011-08 Edition 3.0, Medical Electrical Equipment. Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
(Notes: Applies to 3-wire/5-wire acquisition module only; when used in conjunction with Surveyor Central Station ) IEC 60529:2001-02, Degrees of protection provided by enclosures (IP Code), Edition 2.1. IEC 62366:2007-10 Edition 1.0, Medical devices Application of usability engineering to medical devices. ETSI EN 301 489 1:2011-09 v1.9.2, Electromagnetic compatibility and Radio Spectrum Matters, Part1: Common technical requirements ETSI EN 301 489 17:2012-09 v2.2.1, Electromagnetic compatibility and Radio Spectrum Matters, Part17: Specific conditions for Broadband Data Transmissions Systems 46 ETSI EN 300 328:2006-10 v1.7.1, Electromagnetic compatibility and Radio Spectrum Matters, Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques ISO10993-1:1997-12-15, 2nd Edition, ISO10993-5: 1995-05-15, 2nd Edition, ISO10993-10: 2002-
09-01, 2nd Edition + AM1: Biological evaluation of medical devices, Part 1, Part 5, and Part 10 for in vitro cytotoxicity, irritation, and delayed-type hypersensitivity. 21 CFR Part 820, FDA Quality System Regulation (QSR) Part 15 of the FCC rules. 93/42/EEC: Council Directive of 14 June 1993 concerning medical devices. (Medical Device Directive) 99/5/EC: Council Directive on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity. (R & TTE Directive) 2002/96/EC:2003, Waste Electrical and Electronic Equipment 2002/95/EC:2003, Restriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment EC No 1907/2006, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Canadian Medical Device Regulation (MDR) 47
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2013-11-26 | 2422 ~ 2452 | DTS - Digital Transmission System | Class II permissive change or modification of presently authorized equipment |
2 | 2013-04-08 | 2422 ~ 2452 | DTS - Digital Transmission System | |
3 | 2011-09-28 | 2422 ~ 2452 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 | Effective |
2013-11-26
|
||||
1 2 3 |
2013-04-08
|
|||||
1 2 3 |
2011-09-28
|
|||||
1 2 3 | Applicant's complete, legal business name |
TAIYO YUDEN CO., LTD.
|
||||
1 2 3 | FCC Registration Number (FRN) |
0008738361
|
||||
1 2 3 | Physical Address |
43-1, Yawatabara-machi
|
||||
1 2 3 |
Takasaki-shi, Gunma, N/A 370-0024
|
|||||
1 2 3 |
Japan
|
|||||
app s | TCB Information | |||||
1 2 3 | TCB Application Email Address |
c******@telefication.com
|
||||
1 2 3 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 3 | Grantee Code |
RYY
|
||||
1 2 3 | Equipment Product Code |
WYSAAVDX7
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 | Name |
H**** K********
|
||||
1 2 3 | Title |
Deputy General Manager
|
||||
1 2 3 | Telephone Number |
81-27********
|
||||
1 2 3 | Fax Number |
81-27********
|
||||
1 2 3 |
t******@jty.yuden.co.jp
|
|||||
app s | Technical Contact | |||||
1 2 3 | Firm Name |
TAIYO YUDEN CO., LTD.
|
||||
1 2 3 |
Taiyo Yuden Co., Ltd. EMC Center
|
|||||
1 2 3 | Name |
M**** S******
|
||||
1 2 3 |
J**** O******
|
|||||
1 2 3 | Physical Address |
8-1 Sakae-Cho
|
||||
1 2 3 |
Japan
|
|||||
1 2 3 | Telephone Number |
81-27********
|
||||
1 2 3 | Fax Number |
81-27********
|
||||
1 2 3 |
t******@jty.yuden.co.jp
|
|||||
1 2 3 |
t******@jty.yuden.com.jp
|
|||||
app s | Non Technical Contact | |||||
1 2 3 | Firm Name |
TAIYO YUDEN CO., LTD.
|
||||
1 2 3 |
Taiyo Yuden Co., Ltd. EMC Center
|
|||||
1 2 3 | Name |
M******** S********
|
||||
1 2 3 |
J******** O****
|
|||||
1 2 3 | Physical Address |
8-1 Sakae-Cho
|
||||
1 2 3 |
Japan
|
|||||
1 2 3 | Telephone Number |
81-27********
|
||||
1 2 3 | Fax Number |
81-27********
|
||||
1 2 3 |
t******@jty.yuden.co.jp
|
|||||
1 2 3 |
t******@jty.yuden.com.jp
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 3 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
1 2 3 | Yes | |||||
1 2 3 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 10/05/2013 | ||||
1 2 3 | 12/31/2011 | |||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 3 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 3 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wireless LAN Module | ||||
1 2 3 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 | Modular Equipment Type | Limited Single Modular Approval | ||||
1 2 3 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 3 | Original Equipment | |||||
1 2 3 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 3 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 3 | Grant Comments | Power output listed is conducted. Class II Change: This Change incorporates this Module into a Mortara 12 LEAD TELEMETRY TRANSMITTER: S4 as described in this filing. Any configuration other than the one described will require a separate approval. End end-users must be provided with specific operating instructions for satisfying RF exposure compliance requirements. The highest reported SAR for this values Permissive Change filing are: 0.27 W/kg(Head) and 0.47(Body). | ||||
1 2 3 | Power output listed is conducted. Class II Change: This Change incorporates this Module into a RICOH Operation Panel R-1Y1W7AN as described in this filing. Any configuration other than the one described will require a separate approval. End end-users must be provided with specific operating instructions for satisfying RF exposure compliance requirements. The highest measured SAR for this Permissive Change filing is: 0.16 W/kg. | |||||
1 2 3 | Power output listed is conducted. This module may only be installed by the OEM or an OEM integrator in the products as specified in this filing. . The antenna(s) used for this device must not be co-located or operating in conjunction with any other antenna or transmitter. OEM integrators must be provided with transmitter operating conditions for satisfying RF exposure compliance. Maximum measured SAR value: 1.1W/kg (Body) | |||||
1 2 3 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 | Firm Name |
TAIYO YUDEN CO., LTD.
|
||||
1 2 3 |
Taiyo Yuden Co., Ltd. EMC Center
|
|||||
1 2 3 | Name |
K****** N******
|
||||
1 2 3 |
J******** O********
|
|||||
1 2 3 | Telephone Number |
81-27********
|
||||
1 2 3 |
81-27********
|
|||||
1 2 3 | Fax Number |
81-27********
|
||||
1 2 3 |
81-27********
|
|||||
1 2 3 |
k******@jty.yuden.co.jp
|
|||||
1 2 3 |
o******@jty.yuden.co.jp
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412 | 2462 | 0.1 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2422 | 2452 | 0.082 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 2412 | 2462 | 0.103 | ||||||||||||||||||||||||||||||||||||
2 | 2 | 15C | 2422 | 2452 | 0.082 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15C | 2412 | 2462 | 0.1 | ||||||||||||||||||||||||||||||||||||
3 | 2 | 15C | 2422 | 2452 | 0.082 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC