FCC ID: OTLM2601A Biomedical Telemetry Transmitter

HP Telemetry System for the HP Viridia Information Center User Guide Part Number M2600-90201 Printed in the U.S.A. December 1999 Third Edition Notice This document contains proprietary information which is protected by copyright. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws. Hewlett-Packard 3000 Minuteman Road Andover, MA 01810-1099

(978) 687-1501 Publication number M2600-90201, Third Edition Printed in USA December 1999 Warranty The information contained in this document is subject to change without notice. Hewlett-Packard makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Hewlett-Packard shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Copyright 1999, 1998 by Hewlett-Packard Company. Printing History Printing History New editions of this document incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Pages that are rearranged due to changes on a previous page are not considered revised. The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. First Edition............................................................... August 1998 Model M2604A Viridia Mainframe, release D.01/D.02/D.03 Model M2601A Viridia Transmitter, release A.00/A.01/A.02 Model M2605A Viridia Wave Viewer, release A.00/A.01/A.02 Model M1403A Digital UHF Telemetry System with Option C03, release D.01/D.02/D.03 Second Edition............................................................... February 1999 Model M2604A Viridia Mainframe, release D.01/D.02/D.03 Model M2601A Viridia Transmitter, release A.00/A.01/A.02 Model M2605A Viridia Wave Viewer, release A.00/A.01/A.02 Model M1403A Digital UHF Telemetry System with Option C03, release D.01/D.02/D.03 Third Edition............................................................... December 1999 HP Telemetry System, Release B Model M2604A Viridia Mainframe, release D.01/D.02/D.03 Model M2601A Viridia Transmitter, release A.00/A.01/A.02/A.03 Model M2605A Viridia Wave Viewer, release A.00/A.01/A.02 Model M1403A Digital UHF Telemetry System with Option C03, release D.01/D.02/D.03 Details about the specific releases are contained in Appendix C. iii About this Book About this Book This Users Guide covers the use of the HP Telemetry System with the HP Viridia Information Center. The HP Telemetry System comprises:

HP M2600A Viridia Telemetry System HP M1403A Digital UHF Telemetry System with Option C03. The Users Guide contains information on performing day-to-day tasks and troubleshooting common problems as well as detailed information about all clinical applications. It includes lists of alarm and inoperative (INOP) messages, and configuration choices. Your purchased system may not include all the functionality described in this manual. User information for the HP Telemetry System is also contained in the HP Viridia Information Center On-line Help. Help focuses on how to complete basic tasks and troubleshoot problems. Appendix C, System Releases, summarizes the differences between the current version of the HP Telemetry System and earlier system releases. THIS GUIDE DOES NOT COVER use of the HP Telemetry System with the HP OmniCare Component Central Monitor. If you are using the HP Telemetry System with the HP OmniCare Component Central Monitor, please refer to the following user documentation HP Viridia Telemetry System/HP OmniCare Component Central Monitor Users Guide, order number M2300-91930, publication date 5/97 HP Viridia Telemetry System Users Reference Manual, order number M2600-90039, publication date 5/97 HP Viridia Telemetry System Users Addendum, order number M2600-90060, publication date 11/97 HP Viridia Telemetry System Users Addendum #2, order number M2600-90080, publication date August 1998 HP Viridia Telemetry System Users Addendum #3, order number M2600-90099, publication date February 1999 HP Viridia Telemetry System User Addendum #4, order number M2600-90222, publication date December 1999. iv Document Conventions Procedures Procedures are indicated in text by the heading Task Summary followed by the following table:

About this Book Step Action 1 2 3 Bold Typeface Objects of actions in procedures appear in bold typeface. Note the following example:

Click the Update button. Warnings Warning Warnings are information you should know to avoid injuring patients and personnel. Cautions Caution Cautions are information you should know to avoid damaging your equipment and software. Notes NoteNotes contain additional information on the HP Telemetry System usage. v HP Telemetry System Warnings HP Telemetry System Warnings The warnings and cautions described below refer to the following devices:

HP M2600A Viridia Telemetry System HP M1403A Digital UHF Telemetry System with Option C03 Warning Do not touch the patient, bed or transmitter during defibrillation. Keep transmitter battery cover closed during defibrillation. Warning Do not install or use power modules for analog output, antennas, and palmtop personal computers (HP Viridia Wave Viewer) within a 2.44 m (8 ft) radius of the patient. Caution Installation and setup must be performed by an HP service representative or designee according to the instructions in HP Viridia Telemetry Installation &

Configuration Guide (part number M2600-90036). vi Contents 1. Introduction to the HP Telemetry System . 1-1 Indications for Use . 1-2 System Overview . 1-4 Transmitters . 1-6 HP Viridia Transmitter . 1-6 HP Viridia Telemetry Battery Extender . 1-8 HP M1400A/B Transmitter . 1-12 Transmitter Features . 1-13 Battery Information. 1-15 Receiver Module . 1-23 Receiver Mainframe. 1-24 Antenna System . 1-25 Turning Telemetry On/Off. 1-26 2. ECG Monitoring . 2-1 Lead Sets & Capabilities . 2-2 Preparing for ECG Telemetry Monitoring. 2-6 Overview. 2-6 Task Summary . 2-6 Making ECG Adjustments . 2-8 Overview. 2-8 Changing Lead/Label . 2-8 Adjusting Wave Size . 2-8 Swapping Leads . 2-9 Making Other Monitoring Adjustments. 2-11 Turning the Transmitter Button On/Off . 2-11 Standby Mode . 2-11 Turning On/Off the Second ECG Channel . 2-13 Optimizing System Performance . 2-13 The Telemetry Signal . 2-14 Frequent Signal Strength and RF INOPS . 2-14 Telemetry INOPs . 2-17 3. ST/AR ST Segment Monitoring. 3-1 ST/AR ST Algorithm . 3-2 Overview. 3-2 Contents-1 The Measurement. 3-2 How the Algorithm Works. 3-3 Displayed ST Data . 3-3 Adjusting Measurement Points . 3-4 Overview . 3-4 Task Summary . 3-4 Establishing ST Reference Beats (Baseline) . 3-5 Turning ST On/Off . 3-6 Overview . 3-6 Task Summary . 3-6 ST Alarms . 3-7 Overview . 3-7 ST Alarm Adjustments. 3-8 ST Alarm and INOP Messages . 3-9 4. SpO2 Monitoring. 4-1 Overview . 4-2 Preparing for Telemetry SpO2 Monitoring . 4-4 Overview . 4-4 Task Summary . 4-4 Making SpO2 Measurements . 4-6 Automatic Measurements . 4-6 Manual Measurements . 4-6 Measurement Limitations . 4-7 SpO2 Transducers . 4-9 Disposable Transducers . 4-9 Reusable Transducers . 4-9 Selecting the Appropriate Transducer. 4-10 Applying the Transducer. 4-11 Overview . 4-11 Warnings . 4-12 Adult Finger Transducer (M1191A) . 4-13 Small Adult/Pediatric Finger Transducer (M1192A) . 4-14 Ear Clip Transducer (M1194A) . 4-15 Disposable Transducers . 4-15 Optimizing Transducer Performance . 4-16 Turning the SpO2 Parameter On/Off. 4-17 Overview . 4-17 Task Summary . 4-17 Turning SpO2 Alarms On/Off . 4-18 Contents-2 Overview. 4-18 Task Summary . 4-18 Turning the Pulse Parameter On/Off . 4-18 Overview. 4-18 Task Summary . 4-18 SpO2 Alarm and INOP Summary . 4-19 5. HP Viridia Wave Viewer Basics . 5-1 Indications for Use . 5-2 Introducing the HP Viridia Wave Viewer . 5-5 Installing the HP Wave Viewer . 5-7 Overview. 5-7 Task Summary . 5-7 Connecting to the Transmitter . 5-9 Overview. 5-9 Connecting Directly . 5-10 Connecting with a Light Pipe . 5-11 Battery Information . 5-13 Battery Types and Battery Life. 5-13 Battery Status . 5-14 When to Replace Palmtop Batteries . 5-14 Removing and Installing Palmtop Batteries . 5-14 Changing the Backup Battery . 5-16 Software License Agreement . 5-18 HP Software License Terms . 5-18 6. HP Viridia Wave Viewer Operation . 6-1 HP Wave Viewer Controls. 6-2 Keys . 6-2 Main Screen . 6-2 Using the HP Wave Viewer . 6-3 Overview. 6-3 Checking ECG Signal Quality . 6-4 Viewing Other Leads . 6-5 Changing the Lead . 6-6 Adjusting ECG Size . 6-6 Estimating the Heart Rate . 6-7 Checking SpO2 Signal Quality . 6-8 Changing the SpO2 Sample Rate . 6-9 Making a STAT SpO2. 6-10 Contents-3 Using Help . 6-11 Deactivatingthe HP Wave Viewer . 6-12 Power Save Mode . 6-12 Exiting the HP Wave Viewer. 6-12 Troubleshooting . 6-13 HP Wave Viewer Inoperative Messages (INOPs) . 6-14 7. Telemetry System Cleaning . 7-1 Cleaning and Disinfection. 7-2 Cleaning the Receiver Mainframe. 7-3 Cleaning the HP Viridia Transmitter & Battery Extender . 7-4 Wiping the Transmitter Exterior . 7-4 Wiping the Battery Compartment . 7-5 Wiping the Battery Extender . 7-6 Soaking the Transmitter & Cradle . 7-7 Cross-infection Prevention for the HP Viridia Transmitter & Battery Extender . 7-8 Cross-infection Prevention and Aeration. 7-9 Making Sure the Equipment Works. 7-13 Cleaning the Palmtop . 7-15 Cleaning ECG Patient Cables and Leads . 7-16 Cleaning . 7-16 Disinfecting . 7-17 Sterilizing . 7-18 Cleaning SpO2 Patient Cables & Transducers . 7-18 HP Adapter Cable . 7-18 HP Reusable Transducers . 7-19 8. Telemetry System Configuration. 8-1 About Configuration . 8-2 Configuration Settings. 8-3 M2604A Mainframe . 8-3 HP M2601X Series Transmitter. 8-5 Changing the Configuration . 8-5 Configuring ReplacementHP Viridia Transmitters . 8-6 Changing Frequencies for HP Viridia Transmitters . 8-8 9. System Safety and Specifications. 9-1 Safety Requirements . 9-2 Declaration . 9-2 Electromagnetic Compatibility . 9-3 Contents-4 HP M2600A Viridia Telemetry System Testing . 9-3 HP M1403A Digital UHF Telemetry System with Option C03 Testing . 9-4 HP Telemetry System Characteristics . 9-5 Avoiding EMI . 9-5 System Symbols. 9-6 Type CF Defibrillation Proof . 9-10 Installation and Maintenance Safety . 9-11 Installation . 9-11 Maintenance . 9-12 Preventive Maintenance . 9-18 End of Life . 9-18 Additional Safety Information . 9-19 System Specifications . 9-20 System Classification . 9-20 Environmental Conditions . 9-21 Electrical Power Specifications . 9-23 Antenna System Specifications . 9-28 Measurement Specifications . 9-32 A. Optional Patient Monitor/Holter Interface (Analog Output) . A-1 Overview . A-2 Correct Labeling . A-2 Analog Output Bedside Monitor Cables . A-3 Lead Placement and Selection . A-5 Using Non-standard Lead Placement . A-5 Controls for Telemetry Setup. A-6 Functionality with Paced Waves . A-6 Inoperative (INOP) Conditions . A-7 Holter Interface . A-8 B. Accessories and Ordering Information . B-1 C. System Releases . C-1 System Releases. C-1 Release B (December 99) . C-1 August 98. C-2 November 97 (US only) . C-2 May 97 (US Only) . C-2 Enhancement Details . C-3 HP Viridia Transmitter Battery Life. C-3 Contents-5 Latching/Non-latching SpO2 Alarms. C-5 D. Sales and Support Offices . D-1 Contents-6 1 S y s t e m I I n t r o d u c t i o n n t r o d u c t i o n 1 Introduction to the HP Telemetry System This chapter introduces the HP Telemetry System. It includes the following sections:

Indications for Use . 1-2 System Overview . 1-4 Transmitters. 1-6 Receiver Module . 1-23 Receiver Mainframe . 1-24 Antenna System . 1-25 Turning Telemetry On/Off . 1-26 Introduction to the HP Telemetry System 1-1 Indications for Use Indications for Use The paragraphs below are the elements of the indications for use statement for the HP Telemetry System, which consists of the HP Viridia Telemetry System

(M2600A) and the HP Digital UHF Telemetry System (M1403A) with Option C03. Condition The licensed clinician decides that the HP Telemetry System should be used to monitor the patient. The HP Telemetry System is a prescription device. The ECG signal is obtained from accessory electrodes in contact with the patients skin. The SpO2 signal is obtained from an accessory sensor in contact with the patients skin. Prescription Versus Over-

the-Counter Part of the Body or Type of Tissue with which the Device Interacts Frequency of Use The HP Telemetry System is indicated for use when prescribed by a licensed clinician. Physiological Purpose The HP Telemetry System is indicated when the physiological purpose is to monitor the ECG or SpO2 of patients on the order of a licensed clinician. Patient Population Adult and pediatric patients. 1-2 Introduction to the HP Telemetry System Intended Use 1 S y s t e m I n t r o d u c t i o n Indications for Use The HP Telemetry System is a comprehensive ambulatory system solution for the intermediate care unit for adult and pediatric patients. The foundation of the system is a transmitter that can capture and transmit ECG signals and SpO2 values (if available) that are then processed and displayed on the HP Viridia Information Center. The information center generates alarms and recordings, thus notifying clinicians of changes in patients conditions. The Telemetry System communicates with other devices via the HP Viridia monitoring network. NoteSpO2 monitoring is only available with the HP Viridia Transmitter. Warning United States law restricts this device to sale by or on the order of a physician. This product is intended for use in health care facilities by trained health care professionals. It is not intended for home use. Introduction to the HP Telemetry System 1-3 System Overview System Overview The HP Telemetry System includes the HP M2600A Viridia Telemetry System and/or the HP M1403A Digital UHF Telemetry System with Option C03. The Telemetry System is used with the HP Viridia Information Center to provide multi-parameter measurements for transitional care and other ambulatory monitoring environments. The system:

Monitors adult and pediatric patients ECG. Measures pulsatile arterial oxygen saturation (SpO2) and pulse rate. Enables viewing of ECG and SpO2 measurements and waveforms at the patients side. Makes ST segment measurements. The HP Telemetry System consists of:

A transmitter for each patient. An antenna system. A receiver for each transmitter. A mainframe housing up to eight receivers. An HP Palmtop Personal Computer with HP Wave Viewer software (for use with Viridia transmitters only). See Introducing the HP Viridia Wave Viewer on page 5-5 for additional information Dual-band Operation In Release B, the frequency range of the HP Viridia Telemetry System

(M2600A) has been expanded to allow operation in the 590-632 MHz frequency band in addition to the current band of 406-480 MHz. This enhancement is for use in countries where radio rule changes have made a higher band more desirable for providing operating frequencies for medical telemetry. For example, in the U.S.A., a FCC rule change provides primary operation for medical telemetry at UHF TV Channel 37 (608-614 MHz). A new antenna system, which is backwards compatible with existing systems, enables operation to 650 MHz, addressing the needs of these new rules, and allows operation of transmitters in both bands simultaneously. 1-4 Introduction to the HP Telemetry System System Overview 1 S y s t e m I n t r o d u c t i o n

. HP M2600A Viridia Telemetry HP M1403A Digital UHF Telemetry with Option C03 HP Telemetry System Introduction to the HP Telemetry System 1-5 Transmitters Transmitters The following transmitters can be used with the HP Telemetry System:

HP Viridia Transmitter (ECG/SpO2 or ECG-only versions). HP M1400A/B Transmitter (ECG only) Warning Pacemakers can be susceptible to radio frequency (RF) interference from devices such as telemetry transmitters which may temporarily impair their performance. The output power of telemetry transmitters and other sources of radio frequency energy, when used in the proximity of a pacemaker, may be sufficient to interfere with the pacemakers performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient. In order to minimize the possibility of interference, position electrodes, electrode wires, and the transmitter as far away from the pacemaker as possible. See the HP Viridia Information Center Users Guide for additional information on monitoring paced patients. HP Viridia Transmitter The HP Viridia Transmitter is battery powered and worn by the patient. It acquires the patients ECG and SpO2 signals (if available), processes them, and sends them via the antenna system to the receiver. Measurements are then displayed at the HP Viridia Information Center. The transmitter can also be connected via an infrared link to the HP Viridia Wave Viewer on a HP palmtop computer to provide display of patient measurements and waveforms at the patients side. 1-6 Introduction to the HP Telemetry System Transmitters SpO2 Transducer Connection Transmitter Button Chest Diagram with LEADS OFF Lights 1 S y s t e m I n t r o d u c t i o n ECG Lead Set Connection Combiner Clip InfraRed Link to HP Palmtop PC and Wave Viewer Tel 4

Battery Compartment Transmitter Label Radio Licence Label

(not used in USA) ECG Connection: The Viridia Transmitter supports a 3- or 5-wire ECG cable compatible with HP Viridia CMS/24 ECG trunk cables. CMS trunk cables must include telemetry combiners. In addition to keeping dirt out of the connectors, the combiner has a locking mechanism to keep the lead set attached securely to the transmitter. For safety, every lead should be secured to an electrode on the patient. Disconnection of Leadset: When youre ready to disconnect the leadset, lift the clip of the combiner to release the lock. Then, holding the combiner firmly, rock the leadset free. Do not pull on the lead wires. SpO2 Connection: In addition, the HP Viridia transmitter supports a SpO2 transducer connection. SpO2 can be measured continuously, intermittently at 1 or 5 minute intervals, or manually. Reusable sensors in adult finger, small adult/

pediatric finger, and ear clip models can be used, as well as Oxisensor II disposable sensors. See Appendix B, Accessories and Ordering Information for a list of sensors. Introduction to the HP Telemetry System 1-7 Transmitters HP Viridia Telemetry Battery Extender Chest Diagram & LEADS OFF Lights: The diagram on the front of the HP Viridia Transmitter shows standard lead placement for a 5-wire lead set. The white, black and red electrode positions represent standard AAMI 3-lead placement; the red, yellow and green electrode positions represent standard IEC 3-lead placement. Non-standard 3-wire lead placement diagrams are available at the HP Viridia Wave Viewer. Each electrode position has a light that illuminates if the corresponding electrode becomes unattached. In a LEADS OFF situation, this indicator will help you identify quickly which leads are off and re-attach them. If the reference lead is off, after you correct the situation you may find other lights illuminated as well. A second function of the Leads Off lights is to indicate successful power-up of the transmitter. When you insert a battery into the transmitter, all five lights should flash once. This indicates that the battery has adequate power for monitoring and that there is no transmitter malfunction. See Inserting Batteries on page 1-20 for details. The electrode lights are also used as an indicator that a manual SpO2 measurement has been initiated at the transmitter. The HP Viridia Telemetry Battery Extender (M2611A) enables operation of the HP Viridia transmitter with an external power source when a patient is not ambulating. The battery extender can be used with all HP Viridia transmitters shipped after December 1999, and any earlier transmitter that has been upgraded. (To identify an eligible transmitter, look for the opening at the base of the battery compartment.) The battery extender consists of a cradle, which is fitted over the battery compartment of the transmitter, and a cable connecting to a wall-mounted DC power module. When the battery extender is in use, no battery power is used

(battery save mode). NoteThe purpose of the battery extender is to conserve battery life; the extender does not recharge the battery. 1-8 Introduction to the HP Telemetry System Transmitters 1 S y s t e m I n t r o d u c t i o n Power Module Wall Cable Cradle Cradle Wire Connector HP Viridia Telemetry Battery Extender Introduction to the HP Telemetry System 1-9 Transmitters Connecting to the Battery Extender To use an HP Viridia transmitter in battery-save mode, connect the transmitter to the battery extender in the following steps:

Step Action 1 Slip the cradle onto the base of the transmitter, aligning the extender prongs with the opening at the base of the transmitter. Press until you hear a click. NoteFor accurate functioning, the battery cover must remain closed when the extender is in use. In addition, Hewlett-Packard recommends that the battery remain in the transmitter while the extender is in use. 2 Connect the aqua connector between the cradle wire and the wall cable. Be sure the connection is secure; the yellow band of the connector should be completely covered. 3 Insert the power module into a wall power source. 1-10 Introduction to the HP Telemetry System 1 S y s t e m I n t r o d u c t i o n Transmitters Disconnecting from the Battery Extender To disconnect a transmitter from the battery extender for ambulatory monitoring, perform the following steps:

Step Action 1 2 Disconnect the aqua connector between the cradle wire and the wall cable. NoteThe connector is designed to come apart on its own if the patient gets up without disconnecting the connector. Tuck the loose end of the cradle wire into the pouch. NoteRemoving the power module from the wall receptacle during monitoring causes the transmitter to reset and reboot before switching to battery power. During this brief interval, data from the transmitter is not available at the central station. This interruption does not occur if the cable is disconnected or if the transmitter is removed from the cradle. Introduction to the HP Telemetry System 1-11 Transmitters HP M1400A/B Transmitter The HP M1400A/B telemetry transmitter acquires the patients ECG signal, amplifies and digitizes it, detects pace pulses, then sends it via an Ultra High Frequency (UHF) channel to a receiver in the receiver mainframe. TRANSMITTER BUTTON LEAD SET CONNECTION BATTERY COMPARTMENT

(BACK) Connecting/Disconnecting the Lead Set: The M1400A/B Transmitter supports 3, 4, or 5-lead sets. For safety, every lead should be secured to an electrode on the patient. To connect the lead set, push the lead block down firmly until it locks. 1-12 Introduction to the HP Telemetry System To disconnect the lead set, press in the tab on the lead block (as shown below) and pull the block up. Do not pull on the lead wires. Transmitters PULL UP PRESS

(PLEASE DO NOTE PULL ON WIRES) 1 S y s t e m I n t r o d u c t i o n Transmitter Features Transmitter Button Both the HP Viridia Transmitter (see page 1-6) and the M1400A/B Transmitter

(see page 1-12) have a transmitter button. Depending on how it is configured, pressing this button produces:

A Nurse Call message and tone A Nurse Call message and tone, plus a delayed recording A delayed recording No response at the HP Viridia Information Center. NoteDelayed recordings generated by the transmitter button are stored in Alarm Review. If desired, you can turn the transmitter button off for individual patients at the HP Viridia Information Center by using the Telemetry Setup Window. See Turning the Transmitter Button On/Off on page 2-11 for additional information. On the HP Viridia transmitter, the transmitter button can also be used to initiate an SpO2 measurement. See Making SpO2 Measurements on page 4-6 for more information. Introduction to the HP Telemetry System 1-13 Transmitters Water Resistance The Release B HP Viridia transmitter and the battery extender (except the power module) can withstand submersion in water for 5 minutes and exposure in a shower for 10 minutes. If the battery compartment gets wet, remove the battery and wipe the compartment dry before monitoring. See Chapter 7. Telemetry System Cleaning for details. Caution Disconnect the battery extender cradle from the power module prior to a patients showering. Earlier HP Viridia transmitters and the M1400A/B transmitters are also resistant to water. If either transmitter is exposed to liquids, remove the battery and dry the battery compartment thoroughly before monitoring. If the transmitter or battery extender needs cleaning, follow the instructions in Cleaning the HP Viridia Transmitter & Battery Extender on page 7-4 or Cross-infection Prevention for the HP Viridia Transmitter & Battery Extender on page 7-8. Pouch Use During normal use, the HP Viridia transmitter should be worn over clothing, in a pocket, or preferably in a pouch. Warning Place the HP Viridia transmitter in a pouch or over clothing, or both, during patient use. The transmitter should not touch the patients skin during normal use. Automatic Shutoff A service feature of the HP Viridia Transmitter is RF Automatic Shutoff, which causes the transmitter to stop broadcasting a radio signal if there is no ECG signal for 10 minutes. This prevents interference with other transmitters in use. The INOP message at central is TRANSMITTER OFF. To restart monitoring, attached leads to the patient. Automatic Shutoff can be configured off. When configured off, batteries must be removed when the transmitters are not in use to prevent RF interference and unnecessary battery drain. The M1400A/B transmitters do not have the Automatic Shutoff feature. 1-14 Introduction to the HP Telemetry System Battery Information 1 S y s t e m I n t r o d u c t i o n Transmitters The HP Viridia Transmitter and the M1400A/B Transmitter battery compartments are capable of accommodating any type of standard 9 volt battery. An 8.4 volt Zinc-Air battery can be used with the M1400A/B transmitter and ECG-only version of the HP Viridia transmitter. The transmitter was not designed for use with rechargable batteries. The battery compartment is located at the bottom of the HP Viridia Transmitter and the M1400A/B Transmitter. The length of time the battery lasts depends on:

The type of transmitter. The battery. The parameters being monitored - ECG only, ECG and continuous SpO2, or ECG and intermittent SpO2. When battery power is running low, the INOP message BATTERY WEAK appears in the patient sector to indicate the amount of battery life remaining:

HP Viridia transmitter - at least 15 minutes M1400A/B transmitter - approximately 1 hour When there is no battery life remaining, the INOP message REPLACE BATTERY is displayed. NoteIf the BATTERY WEAK message appears when you are making a STAT SpO2 measurement, or changing the SpO2 sample rate out of Manual, it may be necessary to replace the battery immediately in order to continue monitoring. Be careful not to short circuit the battery. Short circuiting is caused when a piece of metal touches both buttons (positive and negative terminals) at the top of the battery simultaneously (for example, carrying batteries in a pocket with loose change). More than a momentary short circuit will generally reduce the battery life. Introduction to the HP Telemetry System 1-15 Transmitters Warning Certain failure conditions, such as extended short circuiting, can cause a battery to overheat during normal use. High temperatures can cause burns to the patient and/or user, or cause the battery to flame. If the transmitter becomes hot to the touch, place it aside until it cools. Then remove the battery and discard it. Its a good idea to place a piece of tape across the contacts of the battery to prevent inadvertent shorting. Have transmitter operation checked by service to identify the cause of overheating. The battery should be removed when the transmitter is stored. Warning Batteries should be removed from the transmitter at the end of the batterys useful life to prevent leakage. Warning If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Clean the battery compartment according to instructions in Chapter 7. Telemetry System Cleaning. Use of Zinc-Air Batteries Zinc-Air batteries can be used with ECG-only models of the HP Viridia transmitter, release A.01 and later, and with M1400A/B transmitters. A Zinc-Air battery cannot be used with an ECG/SpO2 transmitter. For maximum performance, observe the following guidelines:

Use Zinc-Air batteries within 1 year of manufacture. Use Zinc-Air batteries within three months of opening the sealed package. Store and use Zinc-Air batteries at near room temperature. They can lose 50% of their capacity at low temperatures (0oC /32oF and below). Do not put Zinc-Air batteries in an environment with restricted air flow

(for example, a plastic bag). Serious restriction of air flow can affect battery capacity. During normal use, the battery compartment provides adequate air flow. 1-16 Introduction to the HP Telemetry System Transmitters Zinc-Air batteries may take up to one minute to get to working voltage after they are removed from the airtight wrapper. You can hasten this by shaking the battery. Maximizing Battery Life By observing the following guidelines, you can optimize battery life in the HP Viridia transmitter:

1 S y s t e m I n t r o d u c t i o n REMOVE THE BATTERY (or turn it over/up-end it) when the transmitter is not in use. NoteAutomatic Shutoff does not save battery life. In order to allow an automatic turn-on, the transmitter ECG and SpO2 functions are not completely disabled in this mode. For SpO2 transmitters, when the SpO2 function is not in use, make sure the SpO2 sample rate is set to Manual. See Changing the SpO2 Sample Rate on page 6-9 for directions. Be sure to press End STAT at the end of every STAT SpO2 measurement that is initiated at HP Wave Viewer and wait for the red sensor light to go out before removing the transducer. Disposal of Batteries HP recommends that you remove the battery when the transmitter is not in use. Caution The battery must be removed if a transmitter will be stored for an extended period of time. ImportantWhen disposing of batteries, follow local laws for proper disposal. Dispose of batteries in approved containers. If local regulations require you to recycle batteries, recycle batteries in accordance with regulations. Introduction to the HP Telemetry System 1-17 Transmitters Nominal Battery Life Expectancy For the HP Viridia Transmitter Recommended Battery Types Nominal Life Expectancy -

ECG Only Nominal Life Expectancy -

ECG &

Continuous SpO2 4 Nominal Life Expectancy -

ECG &

Intermittent SpO2 Nominal Life Expectancy -

ECG with SpO2 Transducer Detached Lithium1

(supplied) 3 days 20 hours 23 hours Alkaline2 1 day 18 hours 8 hours 3 days 1 day 4 hours 1 min. intervals:

1 day 19 hours 5 min. intervals:

2 days 22 hours 1 min. intervals:

20 hours 5 min. intervals:

1 day 10 hours Zinc-Air3 4 days 18 hours Not Applicable Not Applicable Not Applicable 1 Tested with ULTRALIFE U9VL-J batteries. 2 Tested with DURACELL MN1604 batteries. 3 Tested with DURACELL DA146X batteries. 4 Life expectancy is based on transmitter current draw of 43.4 mA. 1-18 Introduction to the HP Telemetry System Transmitters 1 S y s t e m I n t r o d u c t i o n For the M1400A Transmitter:

Battery Type Average Life Expectancy (days)*

Zinc-Air Lithium Mercury 8 5 4 1/2 (Not recommended due to hazardous waste disposal requirements.) Alkaline 3 Carbon-Zinc 1 1/2

* Life expectancy is based on transmitter power consumption of 40 mW. For the M1400B Transmitter:

Battery Type Average Life Expectancy (days)*

Zinc-Air Lithium Mercury 7 4 3 1/2 (Not recommended due to hazardous waste disposal requirements.) Alkaline Carbon-Zinc 2 1/2 1

* Life expectancy is based on transmitter power consumption of 52 mW. Introduction to the HP Telemetry System 1-19 Transmitters Inserting Batteries Task Summary for HP Viridia Transmitter Insert a battery into the HP Viridia Transmitter by performing the following steps:

Step Action 1 Remove the cradle, if present, by squeezing the tops of the tabs (1) and sliding the cradle away from the transmitter (2). 1 1 1 1 2 2 2 Open the battery compartment by pressing down on the compartment door and swinging it into an open hinged position. 1-20 Introduction to the HP Telemetry System Transmitters Step Action 3 Insert the battery, matching the battery polarity with the +/-

indication inside the compartment. 1 S y s t e m I n t r o d u c t i o n 4 When the battery is active after a few seconds, all five of the lights on the chest diagram flash once, then each light flashes individually. Next, if no leadset is attached, one light remains on, or if the transmitter is connected to a patient, no lights remain on. If no lights flash, use a second new battery. If there are still no lights, the transmitter memory may be corrupt. Contact Service. If the lights come on but do not behave as described above, the transmitter has malfunctioned. Contact Service. IMPORTANT: When you replace the battery in a transmitter connected to a patient, if either abnormal condition is in effect, no monitoring will be occurring for the patient until either a new battery or a replacement transmitter is used. Introduction to the HP Telemetry System 1-21 Transmitters Task Summary for HP M1400A/B Transmitter Insert the battery into the M1400A/B Transmitter by performing the following steps:

Step Action 1 2 3 Open the compartment. To remove the old battery, pry up the terminal end with your index finger (as shown below). Insert a new battery by following the +/- diagram on the inside of the compartment. When you place the battery in the compartment, set the base of the battery against the leaf spring, and press the terminal end down (as shown in the following illustration). NoteIt may take about a minute for a Zinc-Air battery to get to working voltage after it is removed from its airtight wrapper. This start up can be hastened by shaking it. ImportantRemove the battery when the transmitter is not in use to prevent interference with signals from other transmitters. 1-22 Introduction to the HP Telemetry System Receiver Module Receiver Module The HP receiver modules are housed in the receiver mainframe. Each receiver module is dedicated to a specific transmitter by an internal identity code. This prevents another patients waveform from being erroneously transmitted and displayed. The receiver acquires the ECG and SpO2 signals from the transmitter and sends them to the receiver mainframe. 1 S y s t e m I n t r o d u c t i o n RECEIVER MAINFRAME RECEIVER MODULE FRONT COVER Introduction to the HP Telemetry System 1-23 Receiver Mainframe Receiver Mainframe The HP receiver mainframe houses up to eight receiver modules. For each receiver, the receiver mainframe calculates the heart rate, and sends the waveform, alarms, inoperative messages (INOPS), and status messages over the HP Viridia monitoring network to the HP Viridia Information Center for display and recording. If SpO2 is available, the transmitter processes the data and sends it to the Viridia Information Center via the network as well. Turning the Receiver Mainframe On or Off

. PRESS POWER BUTTON TO TURN ON PRESS AGAIN TO TURN OFF The receiver mainframe must be turned on for individual transmitters and receivers to work. To turn the receiver mainframe on, press the button on the lower left corner of the front of the mainframe. A green light illuminates to signify the mainframe and all the receivers are on. If the receiver mainframe is turned off, the light and all receiver modules are off. Receiver Mainframe Malfunction Light A red light on the front panel of the mainframe illuminates when either the mainframe or one of the receivers has malfunctioned. Depending on the problem, you may see the message, NO DATA FROM BED, in single or multiple patient sectors. Contact your Hewlett-Packard Service Representative. When the mainframe is first turned on, the red light flashes. If no problems are detected, the flashing stops and the light turns off. 1-24 Introduction to the HP Telemetry System Antenna System Channel Frequencies The frequency of the HP Viridia transmitter and receiver are programmable, thus enabling changes in frequency if interference is detected. In case of interference, contact service. Retaining Telemetry Settings If power to the receiver mainframe is interrupted or turned off, settings controlled by the mainframe such as leads may be affected. If the receiver mainframe is turned off for less than three hours, your settings should still be in effect. If the mainframe is turned off for more than three hours, your settings revert to default, that is, to the configured settings at installation. 1 S y s t e m I n t r o d u c t i o n Antenna System The telemetry antenna system is custom designed for your unit to ensure adequate coverage, therefore the telemetry signal can only be received where there are receiving antennas. After it is received by the antenna system, it is sent to the receiver which recovers the patient's ECG and optional SpO2. This information is then sent to a monitoring display. Introduction to the HP Telemetry System 1-25 Turning Telemetry On/Off Turning Telemetry On/Off Telemetry monitoring can be turned on or off in one of several ways:

Automatically, if Auto Shutoff is enabled at the transmitter and if there is no ECG signal for 10 minutes. This situation creates a TRANSMITTER OFF inop at central. To restart monitoring, re-attach the lead wires. Manually, by removing the transmitter battery. This action creates a NO SIGNAL inop at central. To restart, insert the battery. Manually, by activating Monitoring Standby at the HP Viridia Information Center (click on Patient Window, then Standby). This action creates a MONITOR STANDBY message on the display. To restart monitoring, click on Resume Monitoring in the Patient Sector. 1-26 Introduction to the HP Telemetry System I n t r o d u c t i o n 2 E C G M o n i t o r i n g 2 ECG Monitoring This chapter provides information on setting up and managing ECG monitoring. It includes the following sections:

Lead Sets & Capabilities. 2-2 Preparing for ECG Telemetry Monitoring . 2-6 Making ECG Adjustments . 2-8 Making Other Monitoring Adjustments . 2-11 Optimizing System Performance . 2-13 Telemetry INOPs . 2-17 ECG Monitoring 2-1 Lead Sets & Capabilities Lead Sets & Capabilities HP Viridia Transmitter The HP Viridia Transmitter supports 3- and 5-wire cables. The table below provides a summary of the capabilities of each cable. NoteFor details of electrode placement, see the HP Viridia Information Center Online Help. For 3-wire electrode placement with Lead Select turned off, see also the HP Viridia Wave Viewer Help. Number of Leads 1 Lead Set 3-wire

-Lead Select Off Lead/Label Choices Primary I, II, III, MCL Secondary Not available Position electrodes for desired lead. Standard placement gives Lead II. See the on-line help in the HP Wave Viewer for information on electrode placement. Select Label to match electrode placement. WarningHewlett-Packard recommends you change the lead label only to reflect the physical placement of the electrodes. This ensures that the monitored lead and the label match, and prevents any possible confusion. 2-2 ECG Monitoring Lead Sets & Capabilities Lead Set 3-wire

-Lead Select On Number of Leads Lead/Label 1 Position electrodes in standard placement. Use the HP Wave Viewer to change the lead that is transmitted to the HP Viridia Information Center (see Changing the Lead on page 6-6). Lead selection at the Viridia Information Center is disabled. 5-wire 2 Position electrodes in standard placement. Standard placement provides V1 or MCL1. To monitor a different chest lead, for example, V6 or MCL6, position chest electrode appropriately. Select Lead. Choices Primary I, II, III Secondary Not available I n t r o d u c t i o n 2 E C G M o n i t o r i n g Primary I, II, III, aVL, aVR, aVF, V, MCL Secondary I, II, III, aVL, aVR, aVF, V, MCL ECG Monitoring 2-3 Lead Sets & Capabilities HP M1400A/B Transmitter The HP M1400A/B transmitter supports 3-, 4-, and 5-wire cables. The table below provides a summary of the capabilities of each cable. NoteFor information on electrode placement, see the HP Viridia Information Center online help. Lead Set Number of Leads Lead/Label 3-wire 1 Position electrodes for desired lead. NoteUsing standard placement gives Lead II. Select Label to match electrode placement. WarningHewlett-Packard recommends you change the lead label only to reflect the physical placement of the electrodes. This ensures that the monitored lead and the label match, and prevents any possible confusion. 4-wire 2 Position electrodes in standard placement. Select Lead. Choices Primary I, II, III, MCL Secondary should be set to OFF in the Telemetry Setup Window see Turning On/Off the Second ECG Channel on page 2-13). Primary I, II, III, aVR, aVL, aVF Secondary I, II, III, aVR, aVL, aVF 2-4 ECG Monitoring Lead Sets & Capabilities Lead Set Number of Leads Lead/Label 5-wire 2 Position electrodes for desired lead. For each lead, select Label to match placement. WarningHewlett-Packard recommends you change the lead label only to reflect the physical placement of the electrodes. This ensures that the monitored lead and the label match, and prevents any possible confusion. If the receiver mainframe is configured for Swap Leads, no lead choices can be made in the Patient Window. The primary and secondary leads can be swapped in the Telemetry Setup Window, see Swapping Leads on page 2-9. Choices Primary I, II, III, MCL Secondary I, II, III, MCL, ECG I n t r o d u c t i o n 2 E C G M o n i t o r i n g ECG Monitoring 2-5 Preparing for ECG Telemetry Monitoring Preparing for ECG Telemetry Monitoring Overview The HP Telemetry System provides remote monitoring of the patients ECG for adult and pediatric patients. NoteFor SpO2 setup, see Chapter 4, SpO2 Monitoring Task Summary Perform the following steps to set up for telemetry ECG monitoring:

Step Action 1 2 3 4 5 6 Insert a battery into the transmitter, following the +/- diagram on the inside of the compartment. See Inserting Batteries on page 1-20. Connect the lead set to the transmitter by pushing it down firmly until it locks. You should hear a CLICK. Prepare the skin by:

1. Shaving the hair from electrode sites if necessary. 2. Washing the sites (preferably with soap and water), and rinsing well. 3. Drying briskly to remove skin cells and oils. Attach the electrodes to the lead wires. NoteUse electrodes that are all the same brand and change all the electrodes every 24 hours. Remove electrode backing and check for moist gel. Apply electrodes to the skin by placing the edge down, then rolling down the rest of the pad. Press firmly around the adhesive edge toward the center. See the on-line help for information on electrode placement. Or, for Viridia 3-wire cables only with Lead Select off, see the HP Wave Viewer ECG screen for lead placement information. SeeChanging the Lead on page 6-6. 2-6 ECG Monitoring 2 E C G M o n i t o r i n g Preparing for ECG Telemetry Monitoring Step Action 7 8 9 10 For Viridia transmitters only, verify the lead placement using the HP Wave Viewer. See Checking SpO2 Signal Quality on page 6-8. Support the transmitter by using a pouch, and if necessary, tape the lead wires to the chest. I n t r o d u c t i o n Teach the patient how and when to press the transmitter button. Make adjustments to ECG wave(s) and alarm limits in the Patient Window. See Making ECG Adjustments on page 2-8. During monitoring, respond promptly to INOP conditions to prevent loss of monitoring. ECG Monitoring 2-7 Making ECG Adjustments Making ECG Adjustments Overview You can make the following adjustments from the HP Viridia Information Center:

Change the lead or the lead label. Change the wave size. Swap leads (M1400A/B with 5-wire lead set only). With 4-(M1400A/B only) and 5-wire lead sets, you can monitor two leads. With a 3-wire lead set you can monitor one lead. When monitoring two leads, the first lead is the primary lead. Single lead arrhythmia analysis uses this lead. It is also the lead used for alarm and delayed recordings. Multilead analysis uses both leads. If you are not receiving a good ECG wave and the electrodes are securely attached, you should try changing the lead in which you are monitoring. Bandwidth Bandwidth is not user adjustable, but is assigned automatically by the information center. The settings are:

HP Viridia Transmitter M1400A/B Transmitter ST off ST on Monitor (0-40 Hz) Monitor (0 to 40 Hz) ST (0.67 to 40 Hz) ST (0.67 to 40 Hz) To change the lead/label place your cursor over the wave in the Patient Window and select the lead or label from the pop-up box to match the placement. To change the amplitude of the ECG wave on the display or for recordings, place your cursor over the wave in the Patient Window and select the size you want from the pop-up box. There are five sizes available: 1/4 (smallest), 1/2, 1, 2, and 4 (largest). Changing Lead/Label Adjusting Wave Size 2-8 ECG Monitoring Making ECG Adjustments You can use the 1 mV cal bar on the Patient Window to check the height of the R-wave. If the wave is not at least 0.5 mV high (one-half the size of the cal bar), change the lead. 0.5 mV 1 mV I n t r o d u c t i o n 2 E C G M o n i t o r i n g Swapping Leads Swap leads is available for M1400A/B transmitters with 5-wire lead set only. If Swap Leads is turned on in the telemetry mainframe configuration, you can swap the primary and secondary leads that are broadcast from a 5-wire lead set without moving electrodes. Clicking on Swap leads will cause the secondary wave to be displayed in the primary position, and the primary wave in the secondary position. For example, with standard electrode placement, swapping leads will display MCL as the primary wave and lead II as the secondary wave

(or the reverse). ImportantTo swap leads, you must access the Telemetry Setup Window. There is no swap control in the Patient Window. ECG Monitoring 2-9 Making ECG Adjustments Task Summary Swap leads by performing the following steps:

Step Action 1 1 1 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window, swap leads by clicking the Swap leads button. NoteThe swap control is disabled after each use. To swap again, exit from the Telemetry Setup Window. Re-entering the window activates the control. 2-10 ECG Monitoring I n t r o d u c t i o n 2 E C G M o n i t o r i n g Making Other Monitoring Adjustments Making Other Monitoring Adjustments Turning the Transmitter Button On/Off Overview You can turn the Transmitter Button on the transmitter on or off by using the Telemetry Setup Window. Turning the Transmitter Button off inhibits Nurse Call alarms and/or recordings depending on how your system is set up. Task Summary Turn the Transmitter Button on the transmitter on or off by performing the following steps:

Step Action 1 1 1 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window turn the Transmitter Button on or off by clicking in the Transmitter Button Allow Calls checkbox. A check mark in the checkbox indicates that the transmitter button is on. Standby Mode Overview When a patient is temporarily off the unit or out of antenna range you can suspend monitoring by placing telemetry in Standby Mode. Standby suspends monitoring, and you wont get any waveforms or alarms. If a patient leaves the unit without a transmitter, place telemetry in Standby. NoteIf you remove the leads before putting a patient into Standby, youll get a LEADS OFF INOP, and reminders if configured. ECG Monitoring 2-11 Making Other Monitoring Adjustments Warning If you put telemetry in Standby Mode, you must remember to turn monitoring back on when the patient returns to the unit. If a patient leaves the unit while wearing a transmitter, there will be a NO SIGNAL INOP. Youll need to silence the inop, and when the patient returns to the unit, telemetry monitoring will resume automatically. Standby mode is not needed in this case. Task Summary Place a patient in Standby by performing the following steps:

Step Action 1 2 3 On the Patient Window click the Standby button. Select the patients location from the pre-defined list. Click the Suspend Monitoring button. This indefinitely suspends all monitoring and displays the following messages in the Patient Sector No Data From Bed and Monitor Standby and the location (for example, X-Ray). NoteBe sure to take the bed out of Standby before discharging. Since Standby is associated with the equipment assigned to a bed, if a patient is discharged and the bed is in Standby Mode, that equipment will be in Standby for the next patient, and monitoring will continue to be interrupted. 4 When the patient comes back, restart monitoring by clickinig on Resume Monitoring in the Patient Sector. 2-12 ECG Monitoring Optimizing System Performance Turning On/Off the Second ECG Channel Overview If you have the M1400A/B Transmitter, you can turn the second ECG channel on or off by using the Telemetry Setup Window. Turning the second ECG channel off means that there will only be one ECG wave in Patient Sector, Patient Window, and for ST/AR analysis. I n t r o d u c t i o n 2 E C G M o n i t o r i n g When you turn the second ECG channel on delayed/alarm recordings have two 20-mm waves. When you turn the ECG channel 2 off, delayed/alarm recordings have one 40-mm wave. For a 3-wire lead set, the second ECG channel must be off, otherwise a continuous LEADS OFF message displays. Task Summary Turn the second ECG channel on or off by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window turn the second channel on or off by clicking in the ECG Channel 2 checkbox. A check mark in the checkbox indicates that the channel is on. Optimizing System Performance While telemetry monitoring offers many advantages, it can be a challenge. The reliability and quality of the signal transmission through the air and hospital walls is governed by a number of variables which can be difficult to control. A telemetry system cannot be as dependable as a hardwired bedside monitor that transmits its signal through a wire. The effect of interference on the telemetry system ranges from a momentary loss of ECG to complete inoperability, depending on the situation. The strength, frequency, and proximity of the source of interference to transmitters or the ECG Monitoring 2-13 Optimizing System Performance antenna system are factors that determine the degree of severity. In cases where the source of interference is known - for example, cellular phones, magnetic equipment such as MRI, other radio or motorized equipment - removing or moving away from the source of interference will increase the systems dependability. Warning Telemetry should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable. In this section, well investigate some of the problems affecting ECG signal clarity and when possible, show you how you can greatly enhance performance. NoteThe telemetry system also emits radio frequencies (defined in System Specifications on page 9-20) that may affect the operation of other devices. Contact the manufacturer of other equipment for possible susceptibility to these frequencies. The Telemetry Signal Frequent Signal Strength and RF INOPS The transmitter worn by the patient acquires the patient's physiological data, amplifies and digitizes it, detects pace pulses and broadcasts this information via radio waves to the antenna system. Since the signal passes through the air, it is susceptible to interference from many sources. Because the telemetry system is a wireless system, under certain conditions RF dropouts can occur. Dropouts result from a weak signal or RF interference. There will be signal drops to the bottom of channel for a minimum of 200 ms to indicate to the clinical user that it is a non-physiological event. If dropouts are frequent enough to affect the heart rate count, the TEL CANNOT ANALYZE INOP occurs. The following recording strip is an example of dropouts. If frequent dropouts are occurring, the following section describes some steps you can take to improve performance. 2-14 ECG Monitoring Optimizing System Performance Signal Strength The antenna system is custom designed for your unit, so reliable signal reception is only possible where there are receiving antennas. When the signal is too low, the following INOPS occur:

TEL CANNOT ANALYZE WEAK SIGNAL NO SIGNAL I n t r o d u c t i o n 2 E C G M o n i t o r i n g To correct, first check the location of the patient. If not in the coverage area, do one of the following. Return the patient to the specified antenna coverage area. Put telemetry in Standby Mode. See Standby Mode on page 2-11. Warning If you put telemetry in Standby Mode, you must remember to turn monitoring back on when the patient returns to the unit. See Standby Mode on page 2-11. If the patient is in the coverage area and is stationary, try moving the location of the transmitter or patient about six inches. Radio Frequency Interference Radio frequency (RF) interference is caused by anything that intrudes into the transmitted electrical signal, such as paging transmitters and walkie-talkies. We are all familiar with electrical interference in our homes and cars when it causes snow on the television and static on the radio station. These same types of interference can occur with the transmitted telemetry signal. Even though the HP Telemetry System is designed to resist these effects, interference can occasionally be seen in the form of dropouts. To improve performance, the source of the interference must be identified and eliminated. Muscle and Movement Artifact Muscle and movement artifact differ from radio frequency interference since you can prevent much of the occurrence. Noise on the ECG signal can be caused by many sources, such as interference from other electrical equipment, muscle artifact and respiration variation. It is up to the clinician to use certain techniques to minimize these types of noise. Use the following table to help you troubleshoot the most common sources of ECG noise. ECG Monitoring 2-15 Optimizing System Performance Problem 60-Cycle (AC) Interference Cause Poor electrode placement. Possible non-grounded instrument near patient Muscle Artifact Tense, uncomfortable patient. Poor electrode placement. Tremors. Diaphoresis Irregular Baseline Poor electrical contact. Respiratory interference. Faulty electrodes. Dry electrodes. Remedy Re-apply electrodes Disconnect electrical appliances near patient (one at a time) by pulling wall plugs, to determine faulty grounding. Have engineering check grounding. Make sure patient is comfortable. Check that electrodes are applied on flat non-muscular areas of the torso; dry the skin and re-apply the electrodes if necessary. Re-apply electrodes, using proper technique. Move electrodes away from areas with greatest movement during respiration. Baseline Wander Movement of patient. Make sure patient is comfortable. Improperly applied electrodes. Re-apply electrodes. Check that patient cable is not pulling electrodes. Respiratory interference. Move electrodes away from areas with greatest movement during respiration. Poor Electrode Contact Loose electrodes. Change electrodes, using good skin prep. Defective cables. Replace cables. Lead set not firmly connected. 2-16 ECG Monitoring I n t r o d u c t i o n 2 E C G M o n i t o r i n g Telemetry INOPs Telemetry INOPs The following table lists (in alphabetical order) the telemetry INOPs that can be announced at the HP Viridia Information Center. It also provides suggestions on what to do when an INOP occurs. For ST INOPs, see ST Alarm and INOP Messages on page 3-9. NoteA Hard INOP is more severe than a soft INOP. Hard INOPS have an audible tone, and monitoring and alarms are disabled. In a soft INOP, no audible tone is generated; monitoring and alarms remain active. Message Type Description Action BATTERY WEAK Soft INOP Replace battery. Battery low, at least 15 minutes left (HP Viridia Transmitter) or 1 hour

(M1400A/B transmitter). NoteCertain transient conditions such as manual SpO2 measurement, unaligned transmitter, or heavy infrared use may cause battery weak situation. ECG EQUIP MALF

(HP Viridia Transmitter only) Hard INOP ECG PC board in the transmitter is malfunctioning INTERFERENCE Hard INOP Interference due to outside source. Replace transmitter. Contact Service. Check that there are no transmitters stored with batteries inserted. Change the Viridia transmitter and receiver frequency. Contact service. ECG Monitoring 2-17 Telemetry INOPs Message Type Description Action INVALID LEADSET

(HP Viridia transmitter only) Hard INOP Leadset invalid for the transmitter type, or leadset is connected improperly. INVALID SIGNAL E01 Hard INOP Receiver is picking up a duplicate frequency. LEADS OFF Hard INOP Lead(s) not connected. NO RECEIVER Hard INOP Receiver absent or malfunctioning. Attach correct leadset. Reconnect leadset, pressing until latch clicks. If problem persists, call service. When the transmitter is not being used, turn telemetry monitoring off for the bed. If the situation continues, contact service. If this is a new transmitter, the system must learn the new transmitter ID code -

contact service. Reconnect lead(s). For HP Viridia transmitter, use transmitter lights or the HP Wave Viewer to confirm. This message appears after the mainframe is turned on and indicates the absence of a receiver or a receiver is faulty. Contact service. NO SIGNAL Hard INOP Patient beyond antenna range, no battery, or battery is inserted backwards. Return patient to antenna range/check battery for correct insertion. RECEIVER MALF Hard INOP Receiver is malfunctioning. Contact service. REPLACE BATTERY Hard INOP Battery is unable to power the transmitter, or battery is inserted backwards. Replace battery/check battery for correct insertion. 2-18 ECG Monitoring Message RF INOP Soft INOP TEL CANNOT ANALYZE Hard INOP Type Description Action Telemetry INOPs Used by service in troubleshooting the radio signal. Shorts bursts of data corruption inhibiting an accurate HR count. (Often accompanied by WEAK SIGNAL, NO SIGNAL, or INTERFERENCE INOPs.) Contact service. Check that there are no transmitters stored with batteries. Check to see if the patient is in the coverage area, and return patient if needed. If the patient is in the coverage area and is stationary, move the transmitter or patient about 6 inches (15 cm.). If the situation persists, contact service. I n t r o d u c t i o n 2 E C G M o n i t o r i n g TRANSMITTER MALF

(HP Viridia transmitter only) Hard INOP Transmitter malfunctioning Replace transmitter. Contact service. ECG Monitoring 2-19 Telemetry INOPs Message Type Description Action TRANSMITTER OFF

(HP Viridia transmitter only) Hard INOP Transmitter detected all leads off for 10 minutes and turned itself off. Connect leadset to patient. WEAK SIGNAL Soft INOP Patient at outer range of the antenna system. Check to see if the patient is in the coverage area, and return patient if needed. If the patient is in the coverage area and is stationary, move the transmitter or patient about 6 inches (15 cm.). If the situation persists, contact service. 2-20 ECG Monitoring Overview Overview The SpO2 parameter measures the arterial oxygen saturation. That is, the percentage of oxygenated hemoglobin in relation to the total hemoglobin. If, for example, a total of 97% of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has an oxygen saturation of 97%. The SpO2 numeric that appears on the monitor will read 97%. The SpO2 numeric indicates the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The oxygen saturation is measured using the pulse oximetry method. This is a continuous, noninvasive method of measuring the arterial hemoglobin oxygen saturation. It measures how much light, sent from light sources on one side of the transducer, travels through patient tissue (such as a finger or an ear), to a receiver on the other side. The amount of light getting through depends on many factors, most of which are constant, such as tissue or venous blood). However one of the factors, the blood flow in the arterioles, varies with time - because it is pulsatile. This measurement principle is used to derive the SpO2 measurement. The numeric that is displayed at the HP Viridia Information Center is the Oxygen saturation of the arterial blood - the measurement of light absorption during a pulsation. 4-2 SpO2 Monitoring Warnings When the specified NELLCOR transducers are used, the application must be consistent with the manufacturer's own guidelines. Overview Prolonged, continuous monitoring may increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking may be required due to an individual patient's condition. Setting the high SpO2 alarm limit to 100% is equivalent to switching off the high alarm limit. Therefore the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical practices. Pulse oximetry can overestimate the SpO2 value in the presence of Hb-CO, Met-Hb or dye dilution chemicals. NoteThe SpO2 alarm delay built into the system is ten seconds. That means that the monitor generates an alarm if the averaged numeric value on the display stays beyond the alarm limit for more than 10 seconds. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-3 Preparing for Telemetry SpO2 Monitoring Preparing for Telemetry SpO2 Monitoring Overview Task Summary The HP Viridia Telemetry System provides remote monitoring of SpO2 measurement for adult and pediatric patients. You need to prepare your telemetry patient and perform setup tasks for the measurement to display at either the HP Viridia Information Center or at the HP Wave Viewer. Perform the following steps to set up for telemetry SpO2 monitoring:

Step Action 1 2 Select the site and appropriate transducer (see Selecting the Appropriate Transducer on page 4-10). Adult Finger - use for most adults. Small Adult/Pediatric - use for small adults. Ear Clip - use when neither hand has an appropriate site. Attach the transducer cable to the transmitter. Plug reusable transducers directly into the transmitter. Plug disposable transducers into the adapter cable, then plug the adapter cable into the transmitter. 4-4 SpO2 Monitoring Preparing for Telemetry SpO2 Monitoring Step Action 3 Prepare the transducer (if disposable, remove the protective backing), and attach the transducer to the appropriate part of the patients body. Avoid sites with:

Decreased Arterial Flow, such as edematous tissue or distal to arterial catheters, intravenous catheters and blood pressure cuffs Poor Skin Integrity, such as skin discoloration or nail polish. Excessive Motion Additionally, avoid:

Placing the sensor in an environment with bright lights. If necessary, cover the sensor with opaque material. Use of excessive pressure at the application site, for example, transducer applied too tightly, excessive adhesive tape to secure the transducer, clothing or restraints that are too tight. These result in venous pulsations and inaccurate measurements, and may severely obstruct circulation. Use the pleth wave to check the signal quality at the patients side using the HP Wave Viewer (see Checking SpO2 Signal Quality on page 6-8. If necessary, change the SpO2 sample rate using the HP Wave Viewer (see Changing the SpO2 Sample Rate on page 6-9.) Adjust SpO2 alarms in the Patient Window. Make other adjustments in the Telemetry Setup Window. Inspect the site regularly to ensure skin integrity and correct optical alignment. Proper sensor placement is critical to accurate SpO2 monitoring. 4 5 6 7 8 SpO2 Monitoring 4-5 4 S p O 2 M o n i t o r i n g Making SpO2 Measurements Making SpO2 Measurements Automatic Measurements Manual Measurements SpO2 measurements can be made automatically at pre-determined times, or manually on an as-needed basis. Automatic SpO2 measurements can be generated on a continuous basis, or intermittently at 1 or 5 minute intervals. Automatic measurement intervals are set at the HP Wave Viewer. Please see Changing the SpO2 Sample Rate on page 6-9 to set up the transmitter for automatic measurements. Manual measurements can be initiated at the transmitter or at HP Wave Viewer. SpO2 must be turned on at central for alarms, and for display and trending. For measurements at the transmitter or HP Wave Viewer, the sample rate must be set to any choice except Continuous. To initiate an SpO2 measurement at HP Wave Viewer, see Making a STAT SpO2 on page 6-10. NoteThe HP Wave Viewer should not be connected to the transmitter when you are using the transmitter button to initiate an SpO2 measurement. Task Summary To initiate a manual SpO2 measurement at the transmitter, perform the following steps. Step Action 1 2 3 Plug the transducer cable into the transmitter. Attach the transducer to the patient. Press and hold (~6 seconds) the Transmitter Button until the LA light begins flashing. 4-6 SpO2 Monitoring Measurement Limitations Step Action 4 5 When the transducer light turns off (~ 30 seconds later), the measurement value and time stamp will be displayed at central for up to one hour or until the next measurement is made, whichever comes first. Remove the transducer from the patient after the transducer light goes out. NoteWhen an SpO2 measurement is initiated, if the transmitter button is turned ON in the Patient Window, the transmitter button will also function according to its function defined during system configuration. For example, if the patient button is configured for Nurse Call/Record or Record, a recording will be generated when a manual SpO2 reading is initiated at the transmitter. The recording will include the last SpO2 reading, but not the current reading, which is still in process. NoteIf the transmitter button is turned OFF in the Patient Window, a manual SpO2 measurement can still be made. NoteNo measurement will be made if a Battery Weak condition exists. A measurement initiated before a Battery Weak INOP is displayed will be completed, but no further manual measurements can be made until the battery is replaced. NoteIf a LEADS OFF condition occurs during a manual SpO2 measurement, the appropriate lead light will be lit upon completion of the measurement. Measurement Limitations Refer to this section on problem situations if you have difficulty getting a signal or obtaining accurate measurements. Distortion Ambient light, motion, perfusion or incorrect sensor placement may affect the accuracy of the derived measurements. SpO2 Monitoring 4-7 4 S p O 2 M o n i t o r i n g Measurement Limitations Arterial Blood Flow The measurement depends on the pulsatile nature of blood flow in the arteries and arterioles; with the following conditions arterial blood flow may be reduced to a level at which accurate measurements cannot be made:

shock hypothermia use of vasoconstrictive drugs anemia Wavelength Absorption The measurement also depends on the absorption of particular light wavelengths by the oxyhemoglobin and reduced hemoglobin. If other substances are present which absorb the same wavelengths, they will cause a falsely high, or falsely low SpO2 value to be measured. For example:

carboxyhemoglobin methemoglobin methylene blue indocyanine green*

indiocarmine*

*These chemicals are used in dye dilution cardiac output calculations. Ambient Light Very high levels of ambient light can also affect the measurement; an SpO2 INTERFERENCE message will appear on the display. The measurement quality can be improved by covering the transducer with suitable non see-through material. NoteIf you are using NELLCOR transducers, see the directions for use supplied with these transducers. For care and cleaning instructions, see HP Reusable Transducers on page 7-

19. 4-8 SpO2 Monitoring SpO2 Transducers SpO2 Transducers Disposable Transducers Only use disposable transducers once and then discard. However, you can relocate them to a different patient-site if the first location does not give the desired results. Do not reuse disposable transducers on different patients. Disposable transducers are not available as HP parts in the USA or Canada. Contact NELLCOR Incorporated. Reusable Transducers You can use reusable transducers on different patients after cleaning and disinfecting them. See HP Reusable Transducers on page 7-19 for cleaning instructions. Reusable sensors should be changed to another site regularly. See Appendix B, Accessories and Ordering Information for ordering information. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-9 Selecting the Appropriate Transducer Selecting the Appropriate Transducer The following chart provides a guideline to select the most appropriate transducer for your patient. Select the most appropriate transducer by finding the patients weight on the vertical axis, and drawing a horizontal line across the chart. Each shaded area that the line passes through represents a transducer that you can use on this patient. Areas of dark shading indicate that the transducer is the most appropriate one in that weight range. Areas of light shading indicate that you can use the transducer in this weight range, even though it is not the most appropriate transducer. t l u d A r e g n F i c i r t i a d e P

t l u d A l l a m S r e g n F i Greater than 50 kg 50 40 30 20 15 10 3 2.5 1 Clip 100x140 Preferred Transducer Alternative Transducer D-20 D-25 M1192A M1191A M1194A Disposable Transducers Reusable Transducers 4-10 SpO2 Monitoring Applying the Transducer Applying the Transducer Overview A minimum pulsatile flow must be present at the application site of your patient to obtain measurements. Select an appropriate transducer and apply the transducer properly to avoid incorrect measurements. Applying a small amount of pressure at the application site can improve the measurement. Use one of the preferred application sites for your transducer. Selecting the most suitable transducer and application site will help you to ensure that:

The light emitter and the photodetector are directly opposite each other and that all the light from the emitter passes through the patient's tissues, The application site is of the correct thickness for light to pass through. If the application site is too thick or too thin, an SpO2 NON-PULSATILE INOP will occur. You should then select another site as appropriate. Light Source Photodetector Positioning of the Light Emitters and Photodetector Inspect the application site every 2 to 3 hours to ensure skin integrity and correct optical alignment. If skin integrity changes, move the transducer to another site. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-11 Applying the Transducer Warnings Failure to apply the transducer properly may cause incorrect measurement of SpO2. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. Using a transducer during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the transducer does not appear to be operating properly, remove it immediately from the patient. Using a transducer in the presence of bright lights may result in inaccurate measurements. In such cases, cover the site with opaque material. Injected dyes, such as methylene blue, or intravascular dyshemoglobins, such as methemoglobin, may lead to inaccurate measurements. Performance may be compromised by excessive motion. This can lead to inaccurate SpO2 readings. Avoid placing the SpO2 transducer on any extremity with an arterial catheter, or intravascular venous infusion line. Do not use disposable transducers on patients who exhibit allergic reactions to the adhesive. 4-12 SpO2 Monitoring Applying the Transducer Adult Finger Transducer

(M1191A) Push the transducer over the fingertip in such a way that the fingertip touches but does not protrude from the end of the transducer. The fingernail must be uppermost and the cable must lie on the back of the hand. This ensures that the light sources cover the base of the fingernail giving the best measurement results. The cable can be held in place by the accompanying wristband. Warning Failure to apply the transducer properly may cause incorrect measurement of SpO2. For example, not pushing the transducer far enough over the finger can result in inaccurate SpO2 readings. Pushing the transducer too far, so that the finger protrudes from the transducer, can pinch the finger, resulting in inaccurately low SpO2 readings. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-13 Applying the Transducer Push the transducer over the fingertip in such a way that the fingertip touches but does not protrude from the end of the transducer. Small Adult/

Pediatric Finger Transducer

(M1192A) Warning Failure to apply the transducer properly may reduce the accuracy of the SpO2 measurement. 4-14 SpO2 Monitoring Ear Clip Transducer

(M1194A) Clip the probe onto the fleshy part of the ear lobe as shown in the diagram below. The plastic fixing mechanism helps to minimize artifact generated by patient motion. Do not position the probe on cartilage or where it presses against the head. Applying the Transducer The clip transducer can be used as an alternative if the adult finger transducer does not provide satisfactory results. The preferred application site is the ear lobe, although other application sites with higher perfusion (such as the nostril) can be used. Due to the physiologically lower perfusion in the ear lobe, you should be aware of the reduced accuracy of the measurement and more frequent INOPs. Warning Failure to apply the clip transducer properly may reduce the accuracy of the SpO2 measurement. Disposable Transducers See the Directions for Use supplied by NELLCOR Incorporated for instructions on preparation and application of disposable transducers. Warning When the specified NELLCOR transducers are used, the application must be consistent with the manufacturer's own guidelines. SpO2 Monitoring 4-15 4 S p O 2 M o n i t o r i n g Optimizing Transducer Performance Optimizing Transducer Performance To get the best results from your SpO2 reusable transducer:

Always handle the transducer and cable with care. The soft finger sleeve houses a sensitive electronic device that can be damaged by harsh treatment. Always protect the cable from sharp-edged objects. Use the wristband that is supplied with your M1191A transducer. By keeping the cable between the finger transducer and the wristband fairly loose, you will maintain good monitoring conditions. Normal wear and tear associated with patient movement and regular transducer cleaning naturally mean that your transducer will have a limited lifetime. However, provided you handle the transducer and its cable with care, you can expect useful service from it for up to two years. Harsh treatment will drastically reduce the lifetime of the transducer. Moreover, HP's warranty agreement shall not apply to defects arising from improper use. 4-16 SpO2 Monitoring Turning the SpO2 Parameter On/Off Turning the SpO2 Parameter On/Off Overview The SpO2 parameter is turned on or off at the HP Viridia Information Center by using the Telemetry Setup Window. Turning the SpO2 parameter off at the Information Center also turns off:

SpO2 alarms SpO2 display of numerics SpO2 trending. After you turn SpO2 on, you should adjust the sample rate to match your patients acuity by using the Wave Viewer. After you turn SpO2 off, setting the sample rate to Manual using the Wave Viewer will help you conserve the transmitters battery life. Task Summary Turn the SpO2 parameter on or off by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window, turn SpO2 parameter on or off by clicking in the Parameter ON checkbox. A check mark in the checkbox indicates that SpO2 monitoring is on. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-17 Turning SpO2 Alarms On/Off Turning SpO2 Alarms On/Off Overview Task Summary You can turn SpO2 alarms on or off by using the Telemetry Setup Window. Turn SpO2 alarm on or off by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window turn SpO2 alarms on or off by clicking in the Alarm ON checkbox. A check mark in the checkbox indicates that SpO2 alarms are on. Turning the Pulse Parameter On/Off Overview Task Summary You can turn the SpO2 pulse parameter on or off by using the Telemetry Setup Window. Turn the pulse parameter on or off by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup turn pulse parameter on or off by clicking in the Parameter ON checkbox. A check mark in the checkbox indicates that pulse monitoring is on. 4-18 SpO2 Monitoring SpO2 Alarm and INOP Summary SpO2 Alarm and INOP Summary SpO2 alarms are latching or non-latching, depending on the release of the HP Viridia Receiver Mainframe. For release D.02 and above mainframes, SpO2 alarms are non-latching. That is, when an SpO2 limit is exceeded, if the alarm is not silenced, it will reset automatically if the patients alarm condition returns within the limits. This reduces the number of times you will need to reset alarms at the information center when an alarm condition has been corrected at the patients side (for example, movement-induced artifact alarms). In the D.01 release of the HP Viridia Receiver Mainframe, SpO2 alarms are latching - meaning that they must be silenced by a clinician. Silencing an alarm manually is the only way to reset the alarm indicators (sound, message, and highlighting in the patient sector). To find out which release HP Viridia Receiver Mainframe your unit uses, see your service department. The following table lists the SpO2 alarms and the description of the conditions required to generate these alarms. Message Level Sound Description

**SpO2 > upper limit Yellow Continuous SpO2 value greater than the upper SpO2 measurement limit. ImportantSetting the high SpO2 alarm limit to 100% is equivalent to switching off the high alarm.

**SpO2 < low limit Yellow Continuous SpO2 value less than the lower SpO2 measurement limit. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-19 SpO2 Alarm and INOP Summary The following table lists the SpO2 INOPs. The Action column includes recommendations on what to do when one of these INOPs occurs. Message Description Action SpO2 EQUIP MALF Malfunction in the SpO2 hardware, or transducer/adapter cable damaged Change transducer. Change adapter cable. SpO2 ERRATIC Erratic SpO2 measurements, often due to a faulty transducer or incorrect positioning of the transducer Line up light source and photodetector -

they must be opposite each other and light must pass through the arteriolar bed. If INOP persists, replace transmitter. SpO2 INTERFERENCE May also be caused by optical shunting if sensor too big or too small. Reposition transducer to site with higher perfusion. Replace transducer or adapter cable. Use different sensor with correct fit. Level of ambient light is so high that the SpO2 transducer cannot measure SpO2 or pulse rate. Cover sensor with non-white opaque material (for example, pulse oximeter probe wraps - Posey wrap or equivalent) to reduce ambient light. Transducer or adapter cable is damaged. If INOP persists, inspect and replace transducer or adapter cable as needed. May also be due to electrical interference. Reduce sources of electrical interference. May also be generated by a defective transmitter. If the above corrective actions are ineffective, use a different transmitter, and call service to replace the defective one. SpO2 NO TRANSDUCER SpO2 transducer is disconnected. Reconnect sensor. SpO2 connector on transducer or transmitter is dirty. Replace sensor. Replace transmitter and call service. 4-20 SpO2 Monitoring SpO2 Alarm and INOP Summary Message Description Action SpO2 NOISY SIGNAL

(no sound) Excessive patient movement or electrical or optical interference is causing irregular pulse patterns Locate sensor at site with less movement. Reduce sources of electrical or optical interference. SpO2 NON-

PULSATILE Pulse too weak or not detectable May also be generated by a defective transmitter. SpO2 TRANS MALFUNC The SpO2 transducer is malfunctioning. Call service. Relocate sensor to site with improved circulation. Warm area to improve circulation. Try another sensor type. If the above corrective actions are ineffective, use a different transmitter, and call service to replace the defective one. Replace the transducer or adapter cable. SpO2 connector on the transducer or transmitter is dirty or corroded. Change the transmitter and call service to repair. 4 S p O 2 M o n i t o r i n g SpO2 Monitoring 4-21 SpO2 Alarm and INOP Summary 4-22 SpO2 Monitoring i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i 5 HP Viridia Wave Viewer Basics This chapter provides information about the HP Viridia Wave Viewer, which consists of the supplied HP flash disk card, HP palmtop computer, and light pipe. It includes the following sections:

Indications for Use . 5-2 Introducing the HP Viridia Wave Viewer. 5-5 Installing the HP Wave Viewer. 5-7 Connecting to the Transmitter. 5-9 Introducing the HP Viridia Wave Viewer. 5-5 Software License Agreement . 5-18 NoteFor information about other aspects of Wave Viewer, please refer to the following documentation:

Cleaning of palmtop Configuration Chapter 7 Chapter 8 Using palmtop for non-Wave Viewer applications Palmtop Users Guide

(F1060-90001) HP Viridia Wave Viewer Basics 5-1 Indications for Use Indications for Use The paragraphs below are the elements of the indications for use statement for the HP Viridia Wave Viewer. Condition HP Wave Viewer is generally indicated when the clinician decides to assess the ECG or SpO2 vital signs of adult and pediatric patients while at the patient location and does not need a diagnostic quality display. Prescription Versus Over-

the-Counter Part of the Body or Type of Tissue with Which the Device Interacts Frequency of Use Physiological Purpose Patient Population HP Wave Viewer is a prescription device. HP Wave Viewer does not contact the body or tissue of the patient. HP Wave Viewer is indicated for use when prescribed by a clinician. HP Wave Viewer is indicated when the physiological purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. HP Wave Viewer is not suitable for continuous patient monitoring or detailed diagnostics. Adult and pediatric ambulatory and non-ambulatory patients. 5-2 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Indications for Use Intended Use HP Wave Viewer is intended to be used as a patient assessment tool as an adjunct to the monitoring provided at the central station, not as a substitute. Uses are limited to gross assessment of a patients condition and intermittent reading of ECG/pleth waveforms and pulse/SpO2 values. Indicated categories of use include but are not limited to:

Determination of a patients tolerance to exercise during ambulation. Patient assessment while waiting for information from the central station or for monitoring, diagnostic or therapeutic equipment to arrive. Additional input to a routine physical assessment of a patient such as reading and recording SpO2 values while on rounds. Gross assessment of a patient that can be clearly determined by visual interpretation of physiological waveforms of monitoring bandwidth by a trained clinician, such as asystole and ventricular fibrillation. Other standard uses of portable SpO2 monitors, such as assessment of ventilation and/or O2 therapy. HP Wave Viewer uses specifically excluded are:

Continuous monitoring of a patient. (HP Wave Viewer is not intended as a bedside monitor since alarms and ECG algorithms are not provided.) Determining detailed ECG diagnosis such as ST segment values, R-R variability, or other diagnostic ECG values. (Signals are of monitoring quality only, NOT diagnostic quality. Automated algorithms such as arrhythmia and a cardiotach are not provided.) Monitoring a patient during therapeutic procedures such as defibrillation or electrosurgery. HP Wave Viewer should never be used outside the coverage area provided by the antenna system and central station. HP Viridia Wave Viewer Basics 5-3 Indications for Use Warning HP Wave Viewer is not intended for the following purposes:

A diagnostic patient monitoring tool. The HP Wave Viewer should not be used for detailed ECG diagnosis, such as ST segment values, R-R variability, or any other diagnostic ECG values. A bedside monitor. Continuous monitoring (10 minutes or more) of a patient is not supported. Monitoring a patient during therapeutic procedures, such as defibrillation or electrosurgery. No patient alarms are articulated at the HP Wave Viewer. Telemetry alarms are presented at the central monitor only, and all alarm adjustments must be made at central. Do not use the HP Wave Viewer outside the coverage area provided by the antenna system and the central station. Do not use the palmtop AC power adapter in the patient care vicinity. The AC power adapter meets standard electrical safety requirements, but not the stricter requirements for medical equipment used near patients. 5-4 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Introducing the HP Viridia Wave Viewer Introducing the HP Viridia Wave Viewer The HP Viridia Wave Viewer is a patient assessment tool that allows you to determine the basic cardio-pulmonary condition of a patient while at the patients side. HP Wave Viewer enables snapshot views of a patients condition, thus contributing to nursing productivity. HP Wave Viewer is designed for uses such as:

Verification of correct placement of ECG electrodes and the SpO2 sensor. Patient assessment while waiting for other monitoring, diagnostic or therapeutic equipment to arrive. Gathering additional input during a routine physical assessment of an ambulatory or non-ambulatory patient. HP Wave Viewer provides the following functionality:

Displays the realtime ECG and pleth waveforms, as well as SpO2 and pulse values. Enables choice of SpO2 measurement times - continuous, 1 or 5 minute intervals, or manual (on demand). In intermittent and manual modes, STAT measurements can be made at any time. Displays ECG and SpO2 measurement INOPs at the point of care. Allows configuration of parameters, transmitter, and transmitter frequencies (under password control). Enables configuration of replacement transmitters and transfer of settings from one transmitter to another (under password control). Consists of the supplied HP flash card, HP palmtop computer, stick-on label, and light pipe. Use of HP Wave Viewer as a patient assessment tool is intended as an adjunct to the monitoring provided at the HP Viridia Information Center, not as a substitute. HP Wave Viewer is not intended for continuous monitoring. HP Wave Viewer cannot be used for making adjustments to SpO2 or ECG (if lead select is enabled) outside the coverage area provided by the antenna system and the information center. HP Viridia Wave Viewer Basics 5-5 Introducing the HP Viridia Wave Viewer

. FLASH CARD INSERTION DISPLAY BATTERY COMPARTMENT

(Underneath) INFRARED PORT BACKUP BATTERY Environmental Limits To maintain product reliability, avoid getting the equipment wet and observe the temperature and humidity limits for the palmtop as listed in Environmental Conditions on page 9-21. If the environmental limits are exceeded, performance may no longer meet specifications. 5-6 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Installing the HP Wave Viewer Installing the HP Wave Viewer Overview Before installing the HP Wave Viewer, the palmtop must be operational. if the palmtop is not operational, see the palmtop user documentation for start-up instructions. Caution Hewlett-Packard does not guarantee correct operation of the HP Wave Viewer when other applications are active on the palmtop computer. Rebooting while files or other applications are open can cause file or directory corruption. Task Summary Install the HP Wave Viewer by performing the following steps:

Step Action 1 2 Turn the palmtop on. If any applications are open, close them until your personal information screen appears. Turn the palmtop off. Insert the HP Wave Viewer flash disk card - red arrow side up - into the left end of the palmtop. Turn the palmtop on. HP Viridia Wave Viewer Basics 5-7 Installing the HP Wave Viewer Step Action 3 4

CTRL ALT DEL Press the the system. The Welcome to the HP Wave Viewer screen displays, followed by the Communication Disrupted screen. keys simultaneously to reset (reboot)

NoteIf the HP Wave Viewer does not start up when you insert the disk card, the palmtop may be out of batteries, or the palmtop may have insufficient memory. Two (2) megabytes of memory are required to run the HP Wave Viewer. To access patient measurements, continue by connecting the palmtop to the transmitter. 5-8 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Connecting to the Transmitter Connecting to the Transmitter Overview The palmtop connects to the transmitter through the infrared port. The connection can be made in either of two ways. Directly, by alignment only.The palmtop is positioned within the infrared cone of the transmitter. No additional equipment is needed. Lead II pulse 72 96 SpO2 Help Menu ECG Screen SpO2 Numbers SpO2 Quality System Info System Setup Estimate HR 1mV F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 Through a physical connection using a fiber-optic light pipe. When connected, the transmitter can be moved freely within the light-pipe range. Lead II pulse 72 96 SpO2 Help Menu ECG Screen SpO2 Numbers SpO2 Quality System Info System Setup Estimate HR 1mV F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 HP Viridia Wave Viewer Basics 5-9 Connecting to the Transmitter Connecting Directly To connect the palmtop to the HP Viridia Transmitter directly, perform the following steps:

Step Action 1 2 Turn the palmtop on. Align the infrared port on the palmtop with the infrared port on the transmitter. Make sure that the palmtop port is positioned inside the infrared cone generated at the transmitter. A distance between 1 and 6 inches gives optimum results. He lp Me nu ECG Sc re en SpO 2 Numbers SpO2 Quality Syste m Info Syste m Setup Estima te HR 15 deg. maximum 14 cm (6 in) maximum The Main Screen displays. 5-10 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Connecting to the Transmitter Connecting with a Light Pipe To connect the palmtop to the HP Viridia Transmitter with a fiber optic light pipe, perform the following steps:

Step Action 1 NoteIn order to be used with a light pipe, the palmtop must have a special cover over the infrared port. This cover is packaged with the light pipe. If the palmtop is missing the cover, contact service for assistance. Connect the small end of the light pipe to the protrusion on the cover over the infrared port of the palmtop. 2 Attach the clip end of the light pipe to the transmitter, covering the infrared port completely. 3 Turn the palmtop on. The Main Screen displays. HP Viridia Wave Viewer Basics 5-11 Connecting to the Transmitter Caution The light pipe is made of optical-grade plastic and is therefore subject to breakage. Always handle the light pipe with care. Do not coil the light pipe smaller than 10 cm (4 in) in diameter. Do not kink or bend the pipe sharply, or otherwise handle it roughly. 5-12 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Battery Information Battery Information Battery Types and Battery Life Main Battery Type. Any brand of 1.5-volt, size AA Alkaline batteries or Nickel-Cadmium or Nickel-Metal Hydride (NiMH) rechargeable batteries. Backup Battery Type. 3-volt CR2032 lithium coin cell. If fresh main batteries are maintained, the backup battery should last a year before you replace it. The battery life you get with your palmtop depends on:

The type and quality of batteries you use. How you use your palmtop. (Things like IR and serial communications, modems, and flash-disk memory cards all require higher current and therefore drain your batteries faster.) Whether you use the AC adapter. For typical use without the AC adapter, fresh Alkaline batteries should last from 2 to 8 weeks. Rechargeable batteries used without the AC adapter will get less life than Alkalines--how much less depends on the quality and type of the rechargeable batteries you use. The best way to extend battery life is to use the AC adapter whenever possible. Warning Do not use the palmtop AC power adapter in the patient care vicinity. The AC power adapter meets standard electrical safety requirements, but not the stricter requirements for medical equipment used near patients. When you see the message telling you that the main batteries are low, replace them as soon as possible. This will help you get the most out of your backup battery. HP Viridia Wave Viewer Basics 5-13 Battery Information Battery Status The HP Wave Viewer software monitors the palmtop battery voltage and informs you of the need to replace the batteries via a screen message. You can also use the battery monitor in the setup program within the palmtop System Manager to predict the remaining battery capacity. When the indicator falls below the 1/4 level, fresh alkaline batteries should be installed. Additionally, the palmtop has a self test (

) that includes reading the battery voltage. This self test procedure necessitates rebooting of the palmtop. ESC ON When to Replace Palmtop Batteries Removing and Installing Palmtop Batteries When you see a low-battery message in the display, replace the indicated batteries as soon as possible. If the palmtop beeps and turns off immediately after you turn it on, replace the main batteries. The backup battery, which prevents data loss when the main batteries are dead or out of the unit, should be changed a year after it is installed even if a low backup-battery message doesnt appear. Caution Do not remove the main batteries if the backup battery is dead--complete memory loss will result. Replace the backup battery first in this case. Warning Do not mutilate, puncture, or dispose of batteries in fire. The batteries can burst or explode, releasing hazardous chemicals. Replace batteries with only the types recommended in this manual. Discard used batteries according to the manufacturers instructions. The back-up (lithium) battery can explode if it is inserted incorrectly. 5-14 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Battery Information Changing the Main Batteries Change the main batteries by performing the following steps. Step Action 1 2 3 Close all open applications before changing batteries. Important: Turn your palmtop off and close the case. Remove the battery cover and old batteries. Main Batteries 4 Install two fresh AA batteries, orienting them as shown by the symbols in the battery compartment. HP Viridia Wave Viewer Basics 5-15 Battery Information Step Action 5 6 Replace the cover and turn your palmtop on. If the palmtop wont turn on after you replace the batteries, go back over the procedure and check the orientation of the batteries as shown in Step3--you may have put the batteries in backwards. If you replaced rechargeable batteries (either with Alkalines or another set of rechargeables) be sure to go into Setup and set or verify your battery type and charging setting. (Battery charging is automatically disabled whenever you remove rechargeable batteries.) See the palmtop Users Guide for more information. Changing the Backup Battery Caution Do not remove both the main batteries and the backup battery at the same time--

complete memory loss will result. Change the backup battery by performing the following steps. Step Action 1 2 Important: Turn the palmtop off. Remove the backup-battery cover and pull out the battery tray. 5-16 HP Viridia Wave Viewer Basics i 5 W a v e V e w e r B a s c s n t r o d u c t i o n I i Battery Information Step Action 3 4 5 Remove the old battery from the tray and insert a fresh, 3-volt CR2032 coin cell. Be sure the + on the battery is facing down in the tray. Insert the battery tray back into the palmtop and replace the cover. Turn the palmtop on. If the battery-low message is still present in the display, go back over the procedure and check the battery orientation as shown in Step 3--you may have put the battery in the tray upside down. HP Viridia Wave Viewer Basics 5-17 6 HP Viridia Wave Viewer Operation I n t r o d u c t i o n This chapter provides directions for operating the HP Viridia Wave Viewer. It includes the following sections:

HP Wave Viewer Controls . 6-2 Using the HP Wave Viewer . 6-3 Troubleshooting . 6-13 HP Wave Viewer Inoperative Messages (INOPs) . 6-14 6 W a v e V e w e r i O p e r a t i o n HP Viridia Wave Viewer Operation 6-1 HP Wave Viewer Controls HP Wave Viewer Controls Keys HP Wave Viewer can be operated with only 11 keys - the 10 function keys through label on the screen. F1 key. Functions are defined by the corresponding

- and the F10 ON

. Labels 96 SpO2 Help Menu ECG Screen SpO2 Numbers SpO2 Quality System Info System Setup Estimate HR 1mV F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 Function Keys F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 ON F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 ON Main Screen The Main Screen displays the realtime ECG waveform and the SpO2 status. Labels at the bottom of the display provide access to other screens where you can view data and change settings. 72 PULSE 96

% SpO2 1mV Help ECG F1 F2 SpO2/

Pleth F3 F4 Setup SpO2 F5 Config Estimate HR F6 F7 F8 F9 F10 Main Screen with ECG and Continuous SpO2 6-2 HP Viridia Wave Viewer Operation 8 Telemetry System Configuration This chapter provides information on telemetry system configuration. It includes the following sections:

About Configuration . 8-2 Configuration Settings . 8-3 Changing the Configuration . 8-5 8 C o n f i g u r a t i o n Telemetry System Configuration 8-1 About Configuration About Configuration How your telemetry system performs depends in large part on the configuration choices made during system installation. This chapter provides a summary of the factory-set defaults and the alternative configuration choices that relate to clinical practice. Configuration is performed at the receiver mainframe, except for the Viridia transmitters, which are configured at the HP Wave Viewer, and all settings except frequency pertain to all receivers in the mainframe. Two of the most frequently performed configuration procedures are also included in this chapter. For complete configuration information, including the impact of individual choices, refer to the HP Viridia Telemetry System Installation and Configuration Guide (M2600-90036). 8-2 Telemetry System Configuration Configuration Settings Configuration Settings M2604A Mainframe The following table lists the mainframe configuration settings used by the HP Viridia Information Center. NoteThe HP Viridia Information Center does not use the following settings:

HR Alarm Limits Lead Fallback Bandwidth ST Settings Item Factory Default User Choices GENERAL ALARM PARAMETERS Alarm Suspend 3 Minutes 3 Minutes, Infinite Alarm Reminder

(SpO2 only) GENERAL ECG PARAMETERS ON ON, OFF Extended Monitoring ON ON, OFF M1400X SERIES TRANSMITTERS ECG PARAMETERS Lead Selection - 4 Electrode Primary = II Secondary = I Primary = I, II, III, aVR, aVL, aVF Secondary = I, II, III, aVR, aVL, aVF, Off NoteThe primary and secondary ECGs must be different lead types and primary cannot be off. Lead Labelling - 5 Electrode Primary = II Secondary = OFF Primary = I, II, III, MCL Secondary = I, II, III, MCL, ECG, OFF Lead Labelling - 3 Electrode Primary = II Secondary = OFF Primary = I, II, III, MCL Lead Swap OFF ON, OFF Telemetry System Configuration 8-3 8 C o n f i g u r a t i o n Configuration Settings Item Factory Default User Choices M2601X SERIES TRANSMITTERS ECG PARAMETERS Lead Selection - 5 Electrode Primary = II Secondary = V Primary = I, II, III, aVR, aVL, aVF, MCL, V Secondary = I, II, III, aVR, aVL, aVF, MCL, V, OFF NoteThe ECG primary and secondary must be different lead types, and the primary cannot be OFF. Lead Labelling - 3 Electrode Primary = II Primary = I, II, III, MCL SpO2 PARAMETERS SpO2 Alarm Limits GENERAL PARAMETERS Transmitter Button Function Language High: 100 percent Low: 90 percent High Range = 51-100 percent Low Range = 50-99 percent (increment of 1) Nurse Call and Record English Nurse Call, Record, Both, Disabled English, German, French, Dutch, Spanish, Swedish, Italian, Japanese, Norwegian, Danish, Finnish, Portuguese For configuration of the following items, see HP Viridia Telemetry System Installation and Configuration Guide Auto Self Test Self-test Strip SDN Unit Number SDN Branch Number Country Code Locale Code Frequencies 8-4 Telemetry System Configuration Changing the Configuration HP M2601X Series Transmitter Item The following table lists the configuration settings for the HP Viridia Transmitter. Factory Default User Choices Lead Selection 3-wire lead set Automatic Shutoff (after 10 minutes) User Change Frequency No Yes Yes Yes, No No, Yes No, Yes For configuration of the following items, see HP Viridia Telemetry System Installation and Configuration Guide Country Code Locale Code Frequencies Changing the Configuration In general, configuration changes are best made by the service department. However, occasionally you may be called on to resolve a troublesome situation. For that reason, we have included directions for two of the most commonly performed configuration procedures:

1. Configuring a replacement HP Viridia transmitter to match others in the unit. 2. Changing the frequency in case of excessive interference or if you have a spare transmitter. Both these procedures require an HP Wave Viewer. Consult the service documentation or service representative for more information. Telemetry System Configuration 8-5 8 C o n f i g u r a t i o n Changing the Configuration Configuring Replacement HP Viridia Transmitters NoteBefore configuring a replacement transmitter, check that the status of the transmitter allows a frequency change. To check the status, use HP Wave Viewer and select Config from the Wave Viewer Main Screen. Then, under Xmtr Info1, check for a Freq. Option of 020; under Xmtr Info2, check for USER CHANGE FREQ = NO. If either condition is true, the following Task Summary for reconfiguring a replacement transmitter does not apply; call service for assistance. NoteSetting the frequency to one already in use can cause interference with another transmitter/receiver pair. Task Summary Configure a replacement transmitter by performing the following steps:

Step Action 1 2 3 4 Obtain a transmitter with an existing configuration you want to copy. At the Viridia Information Center, obtain the frequency and check code for the replacement transmitters associated bed found in the Telemetry Frequency Unit Settings Window. See the Viridia Information Users Guide for details. Insert battery in replacement transmitter. At the HP Wave Viewer, set the frequency of the replacement transmitter by:

1. Selecting Config from the HP Wave Viewer Main Screen. 2. Selecting Setup. 3. Entering the password and pressing Enter. 4. Selecting Chang Freq. 5. Entering the frequency for the replacement transmitter from Step 2, followed by ENTER. 6. Entering the check code from Step 2, followed by ENTER. 7. Selecting Confirm to set the new frequency. 8-6 Telemetry System Configuration Changing the Configuration Step Action 5 6 7 At the HP Wave Viewer, copy the configuration from the existing transmitter into the replacement transmitter by:

1. Selecting Setup Menu. 2. Selecting Copy Config. 3. Connecting the transmitter with the existing configuration you want to copy. 4. Selecting Save Config. 5. Connecting the replacement transmitter. 6. Selecting Copy Config. On the Telemetry Frequency Window at the Viridia Information Center, click Learn XMIT Code for the highlighted bed. See the Viridia Information Users Guide for details. Within 10 seconds, press the Patient Button on the replacement transmitter to enable the system to learn the new ID code. 8 C o n f i g u r a t i o n Telemetry System Configuration 8-7 Changing the Configuration Changing Frequencies for HP Viridia Transmitters NoteBefore configuring a replacement transmitter, check that the status of the transmitter allows a frequency change. To check the status, use HP Wave Viewer and select Config from the Wave Viewer Main Screen. Then, under Xmtr Info1, check for a Freq. Option of 020; under Xmtr Info2, check for USER CHANGE FREQ = NO. If either condition is true, the following Task Summary for reconfiguring a replacement transmitter does not apply; call service for assistance. NoteSetting the frequency to one already in use can cause interference with another transmitter/receiver pair. Task Summary Change the frequency by performing the following steps:

Step Action 1 From the Viridia Information Center, set the new frequency for the receiver by:

1. Accessing the Telemetry Frequency Window by clicking on the Telem Freq button on the Unit Settings Window. 2. Entering a password in the Password field. 3. Highlighting the bed/receiver. 4. Entering the new frequency for the receiver in the New Frequency field. NoteThe check code and frequency choices were distributed during shipment. See service for assistance. 5. Entering the check code in the New Check Code field. 6. Clicking on the Set Frequency field. 2 From the HP Wave Viewer Main Screen, set the new frequency for the transmitter by:

1. Selecting Config. 2. Selecting Setup. 3. Entering a password, followed by ENTER. 4. Selecting Chang Freq. 5. Entering the new frequency for the transmitter, followed by ENTER. 6. Entering the check code, followed by ENTER. 7. Selecting Confirm to set the new frequency. 8-8 Telemetry System Configuration 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n 9 System Safety and Specifications This chapter provides information on regulatory requirements compliance for patient safety, safety-oriented installation and maintenance procedures, and specifications for the HP Telemetry System. It includes the following sections:

Safety Requirements . 9-2 Electromagnetic Compatibility . 9-3 System Symbols . 9-6 Installation and Maintenance Safety . 9-11 Additional Safety Information . 9-19 System Specifications . 9-20 System Safety and Specifications 9-1 Safety Requirements Safety Requirements Declaration 0123 The HP Telemetry System, comprising the HP M2600A Viridia Telemetry System and/or the HP M1403A Digital UHF Telemetry System, Option C03, complies with the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and carries CE-marking accordingly. The HP Telemetry System (except the HP Wave Viewer) also complies with the following international safety requirements for medical electrical equipment:

UL 2601-1 CAN/CSA C22.2 NO. 601.1-M90 EN 60601-1/IEC 60601- 1 EN 60601-1-1/IEC 60601-1-1 EN 60601-1-2/IEC 60601-1-2 EN 865:1997 AAMI voluntary performance standards for cardiac monitors sections:

3.1.2.1.c, 3.2.6.1.a-c, 3.2.6.2, 3.2.6.3, 3.2.7, 3.2.8.3, 3.2.8.4, 3.2.8.7, 3.2.9.2, 3.2.9.3 and 3.1.4.1 The system is protected against the effects of defibrillation and electrosurgery. This system provides continuous operation when in use. The HP Viridia Wave Viewer complies with EN 60601-1/IEC 60601-1. The following accessories and system components are independently CE marked to the Medical Device Directives. They are not covered by the CE marking of the HP Viridia Telemetry System:

All SpO2 accessories and equipment Electrodes ECG Lead Sets Authorized EU Representative:

Hewlett-Packard GmbH Medical Production 71034 Boeblingen Germany FAX: (+49) 7031 14 2346 9-2 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Electromagnetic Compatibility Electromagnetic Compatibility The electromagnetic compatibility (EMC) validation of the HP Telemetry System (comprising the HP M2600A Viridia Telemetry System and/or the HP M1403A Digital UHF Telemetry System with Option C03) included testing performed according to the international standard for EMC with medical devices. See the Manufacturers Declaration for details. HP M2600A Viridia Telemetry System Testing EN61000-4-3 During the test program the M2600A was subjected to many EMC tests, both international standard and HP proprietary tests. During most of the testing no anomalies were observed. For three of the tests, EN 61000-4-3 Radiated Immunity, IEC 801-4 Fast Transients, and IEC 801-2 Electrostatic Discharge, some reduced performance was observed. EN61000-4-3 specifies that the product be subjected to a field of 3 V/m over a frequency range of 26 to 1000 MHz with no degradation of performance. At most of the test frequencies over the specified range, no anomalies were observed. However at the transmit/receive frequencies, and a few others, the radiated field caused interference with a resulting drop-out of signal. For these test points the radiated field was reduced to the level at which communication was restored. These reduced levels are shown in the following table. Table 4: Minimum Immunity Level (V/m) In Band Radiation

(Transmit freq. +/- 1 MHz) Transmitter Receiver 0.03 0.01 Out of Band Radiation 1.81 (380 MHz - 400 MHz) 2.83 (at 571 MHz) Pass at 3 V/m System Safety and Specifications 9-3 Electromagnetic Compatibility IEC 801-4 IEC 801-4 specifies that the product be subjected to high speed pulses up to 1000 V applied to the power cord and 500 V applied to all I/O cables greater than 3 m. During all of this testing no anomalies were observed on the central station display. However at pulse levels of 300 V and above applied to the power cord, occasional spikes appeared on the monitor connected to the analog output of the receiver mainframe. These spikes sometimes caused the heart rate reading (on the analog output monitor only) to change momentarily. HP M1403A Digital UHF Telemetry System with Option C03 Testing IEC 801-3 During the test program, the M1403A with Option C03 was subjected to many

(EMC) tests, both international standard and HP proprietary tests. During most of the testing, no anomalies were observed. For two of the tests, IEC 801-3 Radiated Immunity and IEC 801-4 Fast Transient/Burst Immunity, some reduced performance was observed. IEC 801-3 specifies that the product be subjected to a field of 3 V/m over a frequency range of 26 to 1000 MHz with no degradation of performance. At many of the test frequencies over the specified range, no anomalies were observed. At +/- 10 MHz of the transmitter operating frequency, radiated levels were reduced to 0.01 V/m to avoid M1402A receiver channel dropout. During radiated immunity testing of the M1400B transmitter, there were some test points where increased width of the ECG trace was observed. For those test points, the radiated field was reduced to the level at which the ECG trace returned to normal. The reduced passing levels for the M1400B transmitter are as follows:

0.382 to 1.5 V/m from 80 MHz to 140 MHz 0.439 to 2.9 V/m from 300 MHz to 610 MHz IEC 801-4 IEC 801-4 specifies that the product be subjected to high speed pulses up to 1000 V to the power cord and 500 V to all I/O cables greater than 3 m. During and after most of the test pulses, no anomalies were observed. However, at pulse levels above 300 V applied to the power cord, spurious pulses were observed. There was no degradation of performance when 500 V was applied to the input/

output cables. 9-4 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Electromagnetic Compatibility HP Telemetry System Characteristics The phenomena discussed above are not unique to the M2600A or M1403A with Option C03, but are characteristic of wireless patient monitors in use today. This performance is due to the very sensitive high gain front end amplifiers used to display the physiological signals and the nature of wireless communication. Among the many similarly performing monitors already in use by customers, interference from electromagnetic sources is rarely a problem. Avoiding EMI When electromagnetic interference (EMI) is encountered, there are a number of things that can be done to mitigate the situation. Eliminate the source. Possible sources of EMI can be turned off or moved away to reduce their strength. Attenuate the coupling. If the coupling path is through the patient leads, the interference may be reduced by moving and/or rearranging the leads. If the coupling is through the power cord, connecting the M2600A or M1403A with Option C03 to a different circuit may help. Reduce the sensitivity of the system. In all of the EMC testing, the M2600A and M1403A were adjusted to maximum sensitivity. For the ECG amplifier the gain was four times what is normally required. By reducing the gain of the system receiving the EMI, the interference can often be eliminated. Add external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may be of help. An HP Customer Engineer can be of help in determining the need for external devices. System Safety and Specifications 9-5 System Symbols System Symbols The following is an explanation of the symbols found on the hardware components of the HP Telemetry System:

Symbol Explanation AC Line Current. Active Antenna Combiner. Antenna Input. Attention. See instructions for use. Bandpass Filter Battery Polarity Catalog Number 9-6 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Symbol Explanation System Symbols Class 2 Equipment Cradle Connection Data In Data In, Data Out Data Out DC Voltage Date of Manufacture 2 Do Not Reuse. Use Only Once. Dispose of properly after use in accordance with local regulations. System Safety and Specifications 9-7 System Symbols Symbol Explanation Electrical Input Electrical Output. Equipotential Grounding System. Frequency Converter Fuse Input. Grounding system. Indoor Use Only Line Amplifier Mainframe. For future use. 9-8 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Symbol Explanation System Symbols Non-ionizing Radiation Palmtop. Power Polarity Power On/Off Product Option Protective Earth (Ground) Power Tee Serial Number Type CF Defibrillation Proof System Safety and Specifications 9-9 System Symbols Type CF Defibrillation Proof The following symbol indicates that the various instruments connected to the HP Telemetry System are Type CF Defibrillation Proof. TYPE CF DEFIBRILLATION PROOF Type CF Defibrillation Proof equipment is designed to have special protection against electric shocks for intracardiac application (particularly regarding allowable leakage currents by having an F-type isolated or floating applied part), and is defibrillator proof. 9-10 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Installation and Maintenance Safety Installation and Maintenance Safety Caution Installation and setup must be performed by an HP service representative or designee, except for transmitters and wave viewers purchased individually. These can be installed by hospital personnel according to instructions in the Installation and Configuration Guide included in the Service Training Kit. Installation Environment Follow the instructions below to ensure a completely safe electrical installation. The environment where the HP Telemetry System will be used should be relatively free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation, allow sufficient room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open. The HP Telemetry System operates within specifications at ambient temperatures between 0C (32oF) and 55C (131oF). The transmitter ambient temperature specification is between 0C (32oF) and 45oC (113oF). Ambient temperatures which exceed these limits could effect the accuracy of the instrument and cause damage to the components and circuits. Allow at least 5 cm (2 inches) clearance around the instrument for proper air circulation. Grounding To protect hospital personnel, the cabinet of the HP Telemetry System must be grounded. Accordingly, the system is equipped with a detachable 3-wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not available, consult the hospital electrician. Warning Do not use a 3-wire to 2-wire adapter with this instrument. System Safety and Specifications 9-11 Installation and Maintenance Safety Condensation Make sure that during operation, the instrument is free of condensation. Condensation can form when equipment is moved from one building to another, thus being exposed to moisture and difference in temperature. Warning Possible explosive hazard if used in the presence of flammable anesthetics. Maintenance Before beginning monitoring on a patient:

Check for any mechanical damage. Check all the external leads, plug-ins and accessories. Check all the functions of the instrument which are needed to monitor the patient. Ensure that the instrument is in good, working order. ImportantDo not use the HP Telemetry Monitoring System for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the instrument. Contact the hospital biomedical engineer, or your HP Service Representative. Warning Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 9-12 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Installation and Maintenance Safety HP Receiver Mainframe Rear Panel The rear panel of the receiver mainframe is shown below. The back of the mainframe should only be removed by qualified service personnel. AC Power Connector Antenna Input Signal Connector SDN Connectors Analog Output Connector Grounding Lug Fuses Line Voltage Selector Switches System Safety and Specifications 9-13 Installation and Maintenance Safety This is an enlarged view of the right side of the rear panel:

POWER CORD CONNECTOR 2 REMOVE COVER TAB FROM SLOT ANTENNA SYSTEM SIGNAL CONNECTOR MAX. VOLTAGE +25 V

1 UNFASTEN SCREW TO REMOVE PROTECTIVE COVER GROUNDING LUG VOLTAGE SELECTOR SWITCHES FUSES M2604-6X001 1.6A 100/120V 2110-1001 0.8A 230/240V 2110-1002 M1401-6X630, M1401-6X631 M2604-6X000 100/120V 1AT 2110-0782 230/240V T400mA 2110-0536 9-14 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Installation and Maintenance Safety Connectors The connectors on the rear panel of the receiver mainframe are:

Connector Description Fuses AC Power Connector Antenna Input Signal Connector SDN Connectors Patient Monitor/Holter Interface (Analog Output) Option Grounding Lug The input voltage line is protected as follows:

On the M1401A:

100/120V xx 1.0 AT fuse 100/120V xx 1.6 A fuse (Japan) 230/240V xx 400 mA fuse On the M2604A:

100/120V xx 1.6 A 230/240V xx 0.8 A. This is a 3 pin connector, used to input the local line voltage. Mainframe plug is a standard IEC mains inlet receptacle. This is a BNC coaxial connector. These are upstream and downstream connectors that connect to the HP Viridia monitoring network. High Density 50-pin SCSI-type to connect to output connector box. This is a grounding stud connector, used to equalize the grounding potential between products. Secondary Ground Wire A secondary ground wire is provided with this instrument to comply with IEC-

601-1-1. This wire ensures against excessive chassis leakage current in the event of a single fault in the health care facilitys primary grounding means. It is recommended that the secondary ground wire be connected to a ground source separate from the primary grounding source found in the instruments power source. System Safety and Specifications 9-15 Installation and Maintenance Safety NoteAfter servicing, be certain to reconnect the secondary ground wire. Warning Removal of the secondary grounding wire from the rear of the product voids the IEC approval. Lifting the Receiver Mainframe The weight of the receiver mainframe is 45 lbs (20.4 kg) for the M1401A and 37 lbs. (16.9 kg) for the M2604A. When carrying the mainframe, hold it firmly from underneath. For safety reasons, it is strongly recommended that at least two people lift the mainframe. One person should not attempt it. Antenna Amplifiers The antenna amplifiers must be operated only with the Power Supply (AC/DC Adapter), and must be operated at a minimal distance of 2.43 meters (8 feet) from the patient. M26XXA Series Antenna Components For all voltages, use Part Number 0950-3221. M14XXX Series Antenna Components For 220/230-240 Volt operation, use Part Number, HP 0950-3221 (CE Marked). For 100 - 120 Volt operation, use Model 7323-000-01922; Part Number, HP 0950-2038. 9-16 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Installation and Maintenance Safety Patient Monitor/Holter Interface Option If using the optional Patient Monitor/Holter Interface (Analog Output), the connector box must only be operated with the appropriate power supply

(see table below), and must be operated at a minimum distance of 2.43 meters

(8 feet) from the patient. Power Supply for Output Connector Box Location Voltage Part Number U.S./Canada 120V Europe 220/230-240V United Kingdom 220/230-240V Australia 240V South Africa 220/230-240V 0950-3221 0950-3221 0950-3221 0950-3221 0950-3221 NoteAt this time, Hewlett-Packard will make available on request, and in English only, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist the users appropriate qualified technical personnel to repair those parts of the equipment which are classified by Hewlett- Packard to be repairable. System Safety and Specifications 9-17 Installation and Maintenance Safety Preventive Maintenance End of Life Preventive maintenance should be performed by a qualified service person. The Safety and Performance Tests, and what to do if the equipment does not meet these specifications, are described in the Service Training Kit (HP Part Number M2600-90032). Contact your biomedical department if your equipment needs testing for safety or performance. There is no specific, predetermined end of life to the HP Viridia Telemetry System or any of its component products. Hewlett-Packard provides service, support and replacement parts and assemblies throughout the support life of the products that allow them to be repaired should any component of the system fail. Please refer to the HP Viridia Telemetry System Service Training Kit for instructions on how to obtain service or replacement parts and for instructions on preventative maintenance. Your local HP sales or service representative can provide you information regarding the support life of your products. 9-18 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n Additional Safety Information Additional Safety Information Warning The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Warning Strangulation Hazard! Under no circumstances should any pouch be tied solely around a patients neck. Warning Do not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power. Software Hazard Prevention The minimization of hazards arising from errors in the software program is documented in the following reports:

1. Hazard Analysis Report, Revision 1.0, 16 June 1995. 2. Whitebox Test Report, Revision 0.1, 16 June 1995. Includes Safety Fault Tree Analysis. 3. Quality Demonstration Test, 3 January 1997. 4. Clinical Investigations Report, Revision 1.0, 16 May 1997. 5. White Paper Cover Document, Revision B, 19 August 1998. System Safety and Specifications 9-19 System Specifications System Specifications This section lists the system classification, and the environmental and electrical power specifications for the hardware components of the system. For complete specifications, see HP Telemetry System Service Guide, part number M2600-90033. For full power specifications for HP Wave Viewer, see the HP palmtop documentation. System Classification Class I Equipment M2604A Receiver Mainframe M1401A Receiver Mainframe Class II Equipment 0950-2038, 0950-3221 Power Supplies Internally Powered Equipment M2601A Transmitter (Type CF Defibrillation Proof relative to ECG and SpO2 patient applied parts) M1400A/B/J Transmitter (Type CF Defibrillation Proof relative to ECG patient applied parts) All equipment is Ordinary Equipment, IPX0, and provides continuous operation. In addition, the M2601A transmitter withstands submersion in 30 cm (1 ft.) of water for 5 minutes or 10 minutes of water exposure in a shower without degradation of performance. The transmitter has not been investigated to IEC 529. 9-20 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications Environmental Conditions FOR ALL HARDWARE COMPONENTS OF THE HP TELEMETRY SYSTEM EXCEPT WAVE VIEWER, HP VIRIDIA TRANSMITTERS, AND REUSABLE PULSE OXIMETRY TRANSDUCERS Operating Temperature Range: 0 to 55C (32 to 131F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 15 to 95% relative humidity Storage Temperature Range: -40 to +70C (-40 to +158F) Altitude Range: Up to 4570 m (15, 000 ft.) Humidity Range: 90% relative humidity maximum For HP Viridia Transmitter Operating Temperature Range: For ECG ONLY, 0-45C (32-113 F); For SpO2, 0-37C

(32-99 F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 15 to 95% relative humidity, non-condensing Storage Temperature with Data Retention: -40 to +70 C (-40 to 158 F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 15 to 95% relative humidity, non-condensing For Wave Viewer Operating Temperature Range: 0-50C (32-122 F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 90% relative humidity at 40 C (104 F) maximum Storage Temperature with Data Retention: 0-60 C (32-140 F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 90% relative humidity at 40 C (104 F) maximum System Safety and Specifications 9-21 System Specifications For Reusable Pulse Oximetry Sensors Operating Temperature Range: 15-37C (50-98.6 F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 95% relative humidity at 37 C (98.6 F) maximum Storage Temperature Range: -40 to 70 C (-40 to 158 F) Altitude Range: Up to 4570 m (15,000 ft.) Storage Humidity: 95% relative humidity at 65 C (150 F) maximum 9-22 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications Electrical Power Specifications NoteSpecifications for earlier releases of the product may vary slightly. HP M2601A Viridia Transmitter RF Power Output

+6.5 dBm, +1.6/-2.0 dB (2.8 to 6.5 milliwatts) For Japan: -3 to 0.8 dBm (0.5 to 1.2 milliwatts) nominal Carrier Frequency Range Option #001: 406 to 412.5 MHz Option #002: 412.5 to 421.5 MHz Option #003: 421.5 to 430 MHz Option #004: 430 to 440 MHz Option #005: 440 to 450 MHz Option #006: 450 to 460 MHz Option #007: 460 to 470 MHz Option #008: 470 to 480 MHz Option #020: 590 to 632 MHz For M2601A - #ABJ, AR0: Japan only Option #02J: 412.5 to 421.5 MHz Option #03J: 421.5 to 430 MHz Option #05J: 440 to 450 MHz Radio Channel Spacing 25 kHz Defibrillator Protection Transmitter ECG input protected against 5 KV d.c. discharge into a 100 Ohm load Warning Battery door must be closed during defibrillation. Batteries 9V Alkaline, Lithium 8.4 Zinc-Air (ECG-only transmitters) System Safety and Specifications 9-23 System Specifications HP M1400A/B/

J Transmitters Current Draw 12.0 mA (ECG only), 43.4 mA (ECG and SpO2) typical Unless otherwise indicated, specifications apply to all three transmitters. RF Power Output HP M1400A

+3 dBm (2 milliwatts) nominal. HP M1400B

+6 dBm (4 milliwatts) nominal. HP M1400J 0 dBm (1 milliwatt) nominal Carrier Frequency Range 406 to 512 MHz (exact frequency fixed by option), VCXO controlled. Radio Channel Spacing 25 kHz Defibrillator Protection Transmitter ECG input protected against 5 KV d.c. discharge into a 100 Ohm load Warning Battery door must be closed during defibrillation. Batteries 9V Alkaline, Lithium 8.4 or 9V Alkaline, Carbon-Zinc, Lithium, Mercury, Zinc Air. Current Draw HP M1400A 4.5 mA, nominal HP M1400B 6.0 mA, nominal HP M1400J - 4.5 mA, nominal HP M2604A/

M1401A Receiver Mainframe Power Supply For the M2604A: M2604-60001 For the M1401A: M2604-60001, M2604-60000, or M1401-60631 Input Voltage 100/120/220/230-240 VAC selectable +/- 10%. 9-24 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications Frequency Range 47 to 63 Hz Power Consumption For M2604A: 110 VA maximum, 95 VA average, 81 W maximum, 72 W average with 8 M2603A receiver modules For M1401A with #C03: 102 VA maximum, 87 VA average, 75 W maximum, 66 W average with 8 M1402A receiver modules. Controls Front Panel: Power On/Off Rear Panel: Line voltage selector. Indicators Front Panel: Power On (indicator light and mechanical indicating lines on POWER button), Instrument Malfunction, Receiver Status (internally via LED). HP M2603A Receiver Module Connections (rear) Antenna Input Signal connector (BNC) Downstream SDN connector Upstream SDN connector Analog Output Connector AC Power Connector (4 selectable line voltages) Grounding Lug Radiated Immunity 3 Volts/Meter outside of operating receiver bands Frequency Tuning Programmable, synthesizer, PLL controlled. Channel Spacing 25 kHz. Carrier Frequency Range Option #001: 406 to 412.5 MHz Option #002: 412.5 to 421.5 MHz Option #003: 421.5 to 430 MHz Option #004: 430 to 440 MHz Option #005: 440 to 450 MHz Option #006: 450 to 460 MHz Option #007: 460 to 470 MHz System Safety and Specifications 9-25 System Specifications Option #008: 470 to 480 MHz HP M1402A Receiver Module Frequency Range RF Carrier 406 to 512 MHz (exact frequency fixed by option), VCXO controlled. Channel Spacing 25 kHz. Channel RF Bandwidth 10 kHz. HP M2611A Battery Extender Input Voltage 100/120/220/230-240 VAC +/- 10%, based on country needs Frequency Range 47 to 63 Hz, based on country needs Output Voltage 9.5 to 10 VDC Output Current Limit 300 mA max Patient Monitor Holter Recorder Interface

(Analog Output) Option J01 Input Voltage CE Mark Power Module 0950-3221: 100-240 VAC +/- 10%

Frequency Range 47 - 63 Hz. Power CE Mark Power Module 0950-3221: 33 VA maximum Output Voltage CE Mark Power Module 0950-3221: 24 VDC regulated 0 to 1.4 A current range Output Current CE Mark Power Module 0950-3221: 1.4 ampere DC maximum Analog Output Gain (from output of receiver module) High-level outputs: 500 + 5%

9-26 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications Low-level outputs: 1 +7%/-6%

Inoperative Mode (INOP Condition) Output Level High-level output: 10.8 volts + 1.2 volts Low-level output: >100 megohms with respect to reference electrode Delay from Transmitter Input to Analog Output 40 milliseconds max - M1400A/B/J Transmitter 400 milliseconds max -- HP Viridia Transmitter Not intended for use with synchronized cardioversion due to processing delay. Indicators Output Connector Box; Status and Power LEDs Connections Output Connector Box: Input (50-pin jack); Input (Power Module); Output (8 pairs of 9-pin D connectors) Analog Output Card: Output (50-pin jack) Bedside Attenuator: Output (3-conductor phone jack) Holter Attenuator: Output (set of 5-button connectors) ECG Bandwidth M2601A: 0.05 - 40 Hz M1400A/B/J: 0.05-100 Hz To ensure proper operation, installation and setup must be performed by an HP service representative or designee according to the instructions in Patient Monitor/Holter Recorder Interface (Analog Output) Installation Note (part number M2600-90017) and the Patient Monitor/

Holter Recorder Option M1440A #J01 Upgrade Kit (part number M2600-90031). System Safety and Specifications 9-27 System Specifications Antenna System Specifications HP M1406A Line Amplifier Input Voltage 19 - 40 VDC RF Frequency Range 406-512 MHz Current Requirements 50 mA Average Power Consumption About 1.1 Watts. RF Gain 12.5 dB typical, at 465 MHz Indicator Green Power On LED HP M1407A Multiple Unit Power Supply Input Voltage CE Mark Power Module 0950-3221: 100-240 VAC +/- 10%

RF Frequency Range 406-512 MHz Power CE Mark Power Module 0950-3221: 33 VA maximum Frequency Range 47 - 63 Hz Output Voltage CE Mark Power Module 0950-3221: 24 VDC 0 to 1.4 A Output Current CE Mark Power Module 0950-3221: 1.4 ampere DC Indicator Green Power On LED 9-28 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications HP M1408A Active Antenna Combiner Input Voltage 19 - 32 VDC Current Requirements 50 mA Power Consumption Approximately 1.5 Watts, average RF Frequency Range 406-512 MHz RF Gain Antenna: 9.7 dB typical, at 465 MHz Line: 3.5 dB typical, at 465 MHz. Indicators Green LED indicates DC power/signal cable connected correctly. Red LED indicates DC power/signal cable connected incorrectly. HP M2606A Line Amplifier Input Voltage 19-32 VDC Current Requirements 38 mA, maximum Power Consumption 0.75 Watts, average RF Frequency Range 406-650 MHz RF Gain 12.8 dB typical at 406 MHz 12.7 dB typical at 465 MHz 11.8 dB typical at 650 MHz Indicators Green LED indicates DC power/signal cable connected correctly. Red LED indicates DC power/signal cable connected incorrectly. System Safety and Specifications 9-29 System Specifications HP M2607A Multiple Unit Power Supply NoteM2607A specifications cover both power module and power tee. Input Voltage CE Mark Power Module 0950-3221: 100-240 VAC +/- 10%

RF Frequency Range 406-650 MHz Power Consumption 33 VA maximum Frequency Range 47-63 Hz Output Voltage 23 VDC nominal Output Current 1 Amp maximum (Limited by the circuit breaker in the power tee) Indicators Green LED is on when power is present. HP M2608A Active Antenna/

Combiner Input Voltage 19 - 32 VDC Input Current 62 mA maximum Power Consumption 1.1 Watts average (2.0 Watts maximum) RF Frequency Range 406-650 MHz RF Gain Antenna: 9.7 dB at 406 MHz; 10.2 at 465 MHz; 9.7 at 650 MHz Line: 3.2 dB at 406 MHz; 3.5 dB at 465 MHz; 4.0 at 650 MHz Indicators Green LED indicates DC power/signal cable connected correctly. Red LED indicates DC power/signal cable connected incorrectly. 9-30 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications HP M2609A Attenuator Current Carrying Capacity Maximum DC Voltage: +30 VDC maximum Maximum DC Current: 1 A maximum RF Frequency Range:

400-660 MHz RF Attenuation 1-9 dB in increments of 1 dB, based on option HP M2612A Bandpass Filter Current Carrying Capacity Maximum DC Voltage: 32 Volts Maximum DC Current: 1 A Power Requirements Negligible RF Frequency Range

#004 430-440 MHz

#005 440-450 MHz

#006 450-460 MHz

#007 460-470 MHz

#034 590-596 MHz

#035 596-602 MHz

#036 602-608 MHz

#037 608-614 MHz

#038 614-620 MHz

#039 620-626 MHz

#040 626-632 MHz Indicators Green LED is ON when power is present. HP M2616A External Frequency Converter Input Voltage 100-240 VAC +/- 10%

Frequency Range 47-63 Hz System Safety and Specifications 9-31 System Specifications Power Consumption 14.0 VA maximum RF Input Frequency Range 590-632 MHz RF Output Frequency Ranges

#130 460-502 MHz

#136 454-496 MHz

#142 448-490 MHz

#148 442-484 MHz

#154 436-478 MHz

#160 430-472 MHz

#166 424-466 MHz Indicators Green LED is ON when power is present. Measurement Specifications SpO2 Measurement Range (Calibration and Display) 0-100%

Accuracy (1 standard deviation) With HP re-usable transducers M1191A, M1192A: 70-100% +/- 2.5%

With HP re-usable transducer M1194A: 70-100% +/- 4%

With NELLCOR sensors D-25, D-20: 80-100% +/- 3%

Test methods are available from Hewlett-Packard Company upon request. Resolution 1%

SpO2 Numerics Averaging 10 seconds 9-32 System Safety and Specifications 9 S a f e t y S p e c i f i I

c a t i o n s n t r o d u c t i o n System Specifications Calibration Automatic self-calibration when device is turned on. The pulse oximeter is calibrated to display functional saturation. Pulse Rate Measurement Range (Calibration and Display) 30 - 300 b/min. Accuracy

+/- 2%

Test methods are available from Hewlett-Packard Company upon request. Resolution 1 b/min. Display (at HP Viridia Wave Viewer only) Pulse waveform. The waveform is inversely proportional to the pulse volume. ECG Range Input Dynamic: +/- 9 mV DC Offset: +/- 320 mV Cardiotach Alarm: Central station selectable, in 5 b/min. increments. High: 20 - 250 b/min. Low: 15 - 245 b/min. Cardiotach Display: 15 - 300 b/min. Accuracy Gain: +/- 5% at 25o C (77o F) Cardiotach: +/- 3 beats plus +/- 2% of heart rate for constant rate input. At fewer than 15 b/min., the heart rate indication is 0. Cardiotach Alarm: +/- 1 b/min., of displayed value Display Displayed values are presented in whole numbers. System Safety and Specifications 9-33 System Specifications 9-34 System Safety and Specifications B Accessories and Ordering Information This appendix provides a list of telemetry accessories you can order through your Hewlett Packard representative. For a list of sales offices, see Appendix D. Sales and Support Offices. Accessories for HP Viridia Transmitter Description Battery HP Part Number 9 V Lithium (box of 10) 8.4 V Zinc-Air (box of 12) - for use with ECG-

only transmitters only ULBU9VLJ 40455A 3-wire ECG Lead Set Snap, AAMI for M2601A, 0.7 m (30 inch) Grabber, AAMI for M2601A, 0.7 m (30 inch) Snap, IEC for M2601A, 0.7 m (30 inch) Grabber, IEC for M2601A, 0.7 m (30 inch) 5-wire ECG Lead Set Snap, AAMI for M2601A , 0.7 m (30 inch) Grabber, AAMI for M2601A , 0.7 m (30 inch) Snap, IEC for M2601A, 0.7 m (30 inch) Grabber, IEC for M2601A, 0.7 m (30 inch) Combiner Shield 3-wire 5-wire ECG Electrodes High Performance Foam,1/pack, 200/case High Performance Foam,3/pack, 300/case ECG Electrode Kit M2590A M2591A M2594A M2595A M2592A M2593A M2596A M2597A M2598A M2599A 14445A 14445C M2202A Accessories and Ordering Information B-1 I n t r o d u c t i o n B O r d e r i n g I n f o r m a t i o n Description ECG Electrode Kit 30 electrodes Foam, 5/pack, 300/case Foam, 30/pack, 300/case Transmitter Pouch Disposable, 50 /case Disposable, 200/case SpO2 Transducer HP Reusable Adult Finger HP Reusable Pediatric/Small Adult Finger HP Reusable Adult/Pediatric Ear Clip Wristband Nellcor Oxisensor D-20 D-25 Adapter Cable for use with Nellcor Oxisensor disposable transducers HP Part Number 40489E 40493D 40493E 9300-0768-050 9300-0768-200 M1191A M1192A M1194A M1627A M1903A/B M1904A/B M1943A OXISENSOR II is a trademark of NELLCOR Incorporated. NoteDisposable transducers are not available as HP parts in the USA or Canada. In those countries, contact NELLCOR Incorporated directly. B-2 Accessories and Ordering Information Accessories for M1400A/B/J Transmitter Description Battery 8.4 volt Zinc air Box of 12 Zinc air batteries 3-wire ECG Lead Set Snap, AAMI Grabber, AAMI Snap, IEC Grabber, IEC 4-wire ECG Lead Set Snap, AAMI Grabber, AAMI Snap, IEC Grabber, IEC 5-wire ECG Lead Set Snap, AAMI Grabber, AAMI Snap, IEC Grabber, IEC Electrode Set Disposable, 1 per pack/200 per box Disposable, 3 per pack/300 per box Transmitter Pouch Reusable Disposable HP Part Number 1420-0340 40455A M1420A M1421A M1430A M1431A M1422A M1423A M1432A M1433A M1424A M1425A M1434A M1435A 14445A 14445C 1530-1693 9300-0768 I n t r o d u c t i o n B O r d e r i n g I n f o r m a t i o n Accessories and Ordering Information B-3 B-4 Accessories and Ordering Information C System Releases I n t r o d u c t i o n This appendix summarizes the enhancements made during each release of the HP Telemetry System. Releases are identified by date and release codes. For assistance in identifying the release codes of your equipment, see your service department. Also in this appendix youll find summary notes about some of the system enhancements made in previous releases. System Releases Release B

(December 99) Release Codes HP Viridia Transmitter: A.03 HP Viridia Wave Viewer: A.02 HP Viridia Mainframe: D.03 Enhancements Dual RF Frequency Bands HP Viridia Battery Extender HP Viridia Transmitter Battery Life Improvement HP Viridia Transmitter Shower Resistance Manual SpO2 Measurement from Transmitter without HP Wave Viewer C S y s t e m R e l e a s e s System Releases C-1 System Releases August 98 Release Codes HP Viridia Transmitter: A.02 HP Viridia Wave Viewer: A.02 HP Viridia Mainframe: D.03 Enhancements HP Viridia Wave Viewer as Patient Assessment Tool HP Viridia Transmitter Cross-infection Prevention Available Initial SpO2 Sample Rate changed from 1-minute to manual Battery Life Improvement November 97 (US only) Release Codes HP Viridia Transmitter: A.01 HP Viridia Wave Viewer: A.01 HP Viridia Mainframe: D.02 Enhancements SpO2 Parameter Default OFF at Admit SpO2 Alarms Non-latching Battery Life Improvement Zinc-Air Batteries with ECG-only HP Viridia Transmitters May 97

(US Only) Release Codes HP Viridia Transmitter: A.00 HP Viridia Wave Viewer: A.00 HP Viridia Mainframe: D.01 Enhancements First release of system HP Viridia Transmitter with ECG-only and ECG/SpO2 measurements measurements) HP Wave Viewer as Productivity Tool C-2 System Releases Enhancement Details HP Viridia Transmitter Battery Life Recommended Battery Types August 1998 Nominal Life Expectancy -

ECG Only Nominal Life Expectancy -

ECG &

Continuous SpO2 4 Lithium1

(supplied) 3 days 20 hours 14 hours Alkaline2 1 day 18 hours 8 hours Enhancement Details I n t r o d u c t i o n Nominal Life Expectancy -

ECG with SpO2 Transducer Detached 2 days 12 hours 1 day 4 hours Nominal Life Expectancy -

ECG &

Intermittent SpO2 1 min. intervals:

1 day 19 hours 5 min. intervals:

2 days 22 hours 1 min. intervals:

20 hours 5 min. intervals:

1 day 10 hours Zinc-Air3 4 days 18 hours Not Applicable Not Applicable Not Applicable 1 Tested with ULTRALIFE U9VL batteries. 2 Tested with DURACELL MN1604 batteries. 3 Tested with DURACELL DA146 batteries. 4 Life expectancy is based on transmitter current draw of 52.4 mA. C S y s t e m R e l e a s e s System Releases C-3 Enhancement Details November 1997 Recommended Battery Types Nominal Life Expectancy -

ECG Only Nominal Life Expectancy -

ECG &

Continuous SpO2 Nominal Life Expectancy -

ECG &

Intermittent SpO2 Lithium

(supplied) 3 days 16 hours 1.5 - 2.5 days Alkaline*

1 day 8 hours 8 hours 1 day Zinc-Air*

3 days 18 hours Not Applicable Not Applicable

* Tested with DURACELL battery May 97 Battery Type ECG Only ECG & SpO2 Continuous Lithium 3 days 6 hours 16 hours ECG & SpO2 Intermittent 1.5 - 2.5 days Alkaline1 1 day 8 hours 8 hours 1 day 1 Tested with DURACELL battery C-4 System Releases Enhancement Details Latching/

Non-

latching SpO2 Alarms This enhancement reduces the number of times you need to reset alarms at the central station when a condition such as movement-induced artifact has already been corrected at the patients side. With Release D.02 HP Viridia receiver mainframes, SpO2 alarms are non-latching; that is, an active SpO2 alarm or inop automatically resets when the patients condition returns within limits or the inop is corrected, without silencing the alarm.This change affects SpO2 alarms in all modes - continuous, intermittent, and manual. I n t r o d u c t i o n NoteOther telemetry alarms behave differently. For example, ECG telemetry alarms are considered as arrhythmia alarms at the HP Viridia Information Center. Telemetry ST alarms are non-latching. In the D.01 and earlier releases of the HP Viridia Receiver Mainframe, SpO2 alarms are latching - meaning that they must be silenced by a clinician. With latching alarms, silencing an alarm manually is the only way to reset the alarm indicators (sound, message, and highlighting in patient sector). See also Alarm Management and Setup: Silencing Alarms in HP Viridia Information Center User Guide. C S y s t e m R e l e a s e s System Releases C-5 Enhancement Details C-6 System Releases D S a e s O l I f f i c e s n t r o d u c t i o n D Sales and Support Offices For more information, please call your local HP sales office listed in your telephone directory or an HP regional office listed below for the location of your nearest sales office. United States:

Hewlett-Packard Company Medical Products Group Headquarters 3000 Minuteman Road Andover, MA 01810 Medical Customer Information 1-800-934-7372 Canada:

Hewlett-Packard (Canada) Ltd. 5150 Spectrum Way Mississauga, Ontario L4W 5G1

(905) 206-4725 Latin America:

Hewlett-Packard Latin America 5200 Blue Lagoon Drive Suite 900 M/S 1208 Miami, FL 33126

(305) 267-4220 Asia Pacific Headquarters:

Hewlett-Packard Asia Pacific Ltd. 18-19/F & 24-25/F Cityplaza One 1111 Kings Road Taikoo Shing Hong Kong

(+852) 2599 7777 Sales and Support Offices D-1 Australia:

Hewlett-Packard Australia Ltd.

(A.C.N. 004 394 763)

(+61 3) 9272-2698 China:

China Hewlett-Packard Co., Ltd.

(+86 10) 6 505 3888 India:

Hewlett-Packard India Ltd.

(+91 11) 682-6000 Japan:

Hewlett-Packard Japan Ltd.

(+81 3) 3335-8154 Korea:

Hewlett-Packard Korea

(+82 2) 769-0114 Singapore/Southeast Asia:

Hewlett-Packard Singapore (Sales) Pte. Ltd.

(+65) 275-3888 South Africa:

Hewlett-Packard South Africa

(+27) 11 806 10 00 Taiwan:

Hewlett-Packard Taiwan Ltd.

(+886 2) 712-0404 Marketing Center Europe:

Hewlett-Packard GmbH Herrenberger Str. 110-140 71034 Boeblingen Germany Fax: (+49) 7031 14 4096 D-2 Sales and Support Offices D S a e s O l I f f i c e s n t r o d u c t i o n Medical Distribution:

Europe, Middle East, Africa Geneva, Switzerland

(+41) 22 780 4111 Austria/Central Europe:

Austria Office

(+43) 1 25000 6448 Belgium/Luxembourg:

Belgium Office

(+32) 2 778 31 11 Czech Republic:

(+42) 2 613 07 427 Finland:

(+358) 9 887 21 France:

(+33) 1 69 29 43 43 Germany:

(+49) 7031 14 5640 0180 5 32 62 77 Italy:

(+39) 2 92 121 Netherlands:

(+31) 20 547 63 38 Poland:

(+48) 22 608 7700 Russia:

(+7) 095 797-3870 Spain:

(+34) 93 401 9100 Sweden:

(+46) 8 444 20 00 Sales and Support Offices D-3 Switzerland:

(+41) 1 735 71 11 (German Swiss)

(+41) 22 780 41 11 (Suisse Romande) United Kingdom:

(+44) 1344 369 269 D-4 Sales and Support Offices A alarms SpO2, 4-19 ST, 3-7 ST messages, 3-9 turning off SpO2, 4-17 analog output, A-2 bedside monitor cables, A-3 INOPs, A-7 lead placement and selection, A-5 making adjustments, A-6 use with paced waves, A-6 antenna amplifiers, 9-16 artifact muscle and movement, 2-15 automatic shutoff HP Viridia transmitter, 1-14 B batteries Zinc-Air, 1-16 battery disposal, 1-17 inserting HP Viridia Transmitter, 1-20 M1400A/B Transmitter, 1-22 life, 1-18 optimizing life, 1-17 battery extender, 1-8 connecting, 1-10 disconnecting, 1-11, 1-20 C cleaning battery extender, 7-4 ECG patient cables, 7-16 Index palmtop, 7-15 receiver mainframe, 7-3 SpO2 transducers, 7-18 telemetry system, 7-2 Viridia transmitter, 7-4 configuration changing, 8-5 settings, 8-3 connectors receiver mainframe, 9-15 D dropouts, 2-14 E ECG accessories, B-1 changing lead/labels, 2-8 checking signal quality, 6-4 interference, 2-15 lead placement, 2-2 telemetry monitoring, 2-6 turning on/off second channel, 2-13 ECG noise troubleshooting, 2-15 ECG patient cables cleaning, 7-16 ECG waves changing size, 2-8 F frequency changing transmitter, 8-8 Index-1 G grounding secondary ground wire, 9-15 telemetry, 9-11 H heart rate N noise eliminating, 2-15 nurse call, 1-13 P paced patients estimating using wave viewer, 6-7 using analog outputs, A-6 Holter Interface see analog output, A-1 I INOP messages SpO2, 4-19 ST, 3-7 telemetry, 2-17 wave viewer, 6-14 L labels changing ECG, 2-8 lead sets capabilities, 2-2, 2-8 connecting/disconnecting, 1-12 disconnecting HP Viridia transmitter, 1-7 Lead Swap, 2-9 leads changing, 2-8 changing via wave viewer, 6-6 light pipe, 5-9, 5-11 M messages SpO2, 4-19 ST, 3-9 telemetry INOPs, 2-17 wave viewer INOPs, 6-14 Index-2 palmtop cleaning, 7-15 connecting transmitter to, 5-9 keys, 6-2 turning off, 6-12 Patient Button See Transmitter Button, 1-13 Patient Monitor/Holter Interface See analog output pouch, 1-14 R receiver mainframe, 1-24 cleaning, 7-3 connectors, 9-15 rear panel, 9-13 retaining settings, 1-25 turning on/off, 1-24 RF INOPs, 2-14 RF interference, 2-15 S signal strength, 2-15 Smart Limits ST, 3-8 SpO2 accessories, B-2 alarm and INOP messages, 4-19 applying transducers, 4-11 changing the sample rate, 6-9 checking signal quality with wave viewer, 6-8 making measurements, 4-6 making STAT measurements, 6-10 manual measurement from transmitter, 1-8, 1-

13 obtaining accurate measurements, 4-7 selecting transducers, 4-10 telemetry monitoring, 4-4 transducers, 4-9 turning alarms on/off, 4-18 turning parameter on/off, 4-17 turning pulse parameter on/off, 4-18 ST adjusting measurement points, 3-4 alarm adjustments, 3-8 alarm and INOP messages, 3-9 alarms, 3-7 analysis, 3-2 measurement, 3-2 smart limits, 3-8 turning on/off monitoring, 3-6 viewing data, 3-3 standby mode, 2-11 sterilization ECG cables & leads, 7-18 Swap leads, 2-9 T telemetry accessories, B-1 changing ECG wave size, 2-8 changing frequency, 8-6, 8-8 changing lead/label, 2-8 cleaning, 7-2 dropouts, 2-14 ECG monitoring, 2-6 grounding, 9-11 HP M1400A/B transmitter, 1-12 HP Viridia Transmitter, 1-6 INOP messages, 2-17 muscle and movement artifact, 2-15 noise, 2-15 on/off, 1-26 optimizing performance, 2-13 Patient Monitor/Holter Interface, 9-17 preparing for ECG monitoring, 2-6 preparing for SpO2 monitoring, 4-4 receiver mainframe, 9-13 retaining settings, 1-25 RF INOPs, 2-14 RF interference, 2-15 signal strength, 2-15 SpO2 monitoring, 4-2 standby mode, 2-11 suspending monitoring, 2-11 system components, 1-4 turning on/off second channel, 2-13 Telemetry, On/Off, 1-26 transducers, 4-9 adult finger, 4-13 applying, 4-11 cleaning, 7-18 ear clip, 4-15 selecting, 4-10 small adult/pediatric, 4-14 transmitter automatic shutoff, 1-14 battery, 1-15 battery disposal, 1-17 battery life, 1-18 button, 1-13 button on/off, 2-11 changing frequency, 8-8 cleaning, 7-4 connecting palmtop to, 5-9 HP Viridia, 1-6 inserting batteries HP Viridia Transmitter, 1-20 M1400A/B Transmitter, 1-22 Index-3 M1400A/B, 1-12 receiver mainframe, 1-24 storage, 1-16, 1-17 transmitter button turning on/off, 2-11 troubleshooting ECG noise, 2-15 SpO2, 4-7 W water resistance, 1-14 wave viewer adjusting ECG size, 6-6 batteries, 5-13 changing leads, 6-6 changing the sample rate, 6-9 checking SpO2 signal quality, 6-8 controls, 6-2 estimating heart rate, 6-7 exiting, 6-12, 6-13 indications for use, 5-2 INOP messages, 6-14 installing, 5-7 using to make STAT measurements, 6-10 using to view other leads, 6-5 waves changing size on display/recordings, 2-8 changing size via wave viewer, 6-6 Z Zinc-Air batteries, 1-16 Index-4