Spacelabs Healthcare WT12 010-1927-00 User Manual 070 2407 00 Rev A

Spacelabs Healthcare, Inc. 010-1927-00 070 2407 00 Rev A

User Manual

Telemetry Transmitter96281-A, 96281-B, 96281-COperations Manual070-2407-00 Rev. AD R A F T 22 June 2012
©2012Spacelabs HealthcareAll rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Printed in U.S.A. Specifications and price change privileges are reserved.Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if:• assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Spacelabs Healthcare, and• the electrical installation of the relevant room complies with the requirements of the standard in force, and• the equipment is used in accordance with the operations manual.Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist appropriately qualified technical personnel to repair those parts of the equipment which are classified by Spacelabs Healthcare as field repairable. Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Healthcare equipment. CORPORATE OFFICESU.S.A.Spacelabs Healthcare, LLC5150 220th Ave SEIssaquah, WA 98029Telephone: 425-657-7200Telephone: 800-522-7025Fax: 425-657-7212Authorized EC Representative UNITED KINGDOMSpacelabs Healthcare, Ltd.1 Harforde CourtJohn Tate RoadHertford, SG13 7NWHertfordshire, UKTelephone: 44 (0) 1992 507730Fax: 44 (0) 1992 501213BirthNet, Clinical Browser, Data Shuttle, Flexport, Intesys, Mermaid, MOM, Multiview, PCMS, Quicknet, Sensorwatch, TruLink, Ultraview, Ultraview Care Network, Ultraview Digital Telemetry, Ultraview SL, Uni-Pouch, UCW, Varitrend, Dynamic Network Access, DNA, XPREZZON, qube, Xhibit, and AriaTele are trademarks of Spacelabs Healthcare.Other brands and product names are trademarks of their respective owners.Caution:US Federal law restricts the devices documented herein to sale by, or on the order of, a physician.Before use, carefully read the instructions, including all warnings and cautions.Rx Only!D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL iTable of Contents1 IntroductionAbout This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Overview of the Telemetry Transmitter (96281-A/96281-B/96281-C) . . . . . . . . . . . . . . . . . . . . 1-2Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Relationship to Other Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Potential Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Nurses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Monitor Technicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Biomedical Engineers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Sources of Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Potential Sources of Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-92 About the TransmittersTelemetry Transmitters (96281-A, 96281-B, 96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Lead Fault Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Optional Leadwire Grouper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Leadwire Color Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Telemetry Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Lead Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-63ECG and SpO2ECG Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Patient Preparation and Electrode Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1To Set Up ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2To prepare the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2To apply ECG electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Adult Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3ECG Problem Solving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4Lead Fault Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4Noise Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4False Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5SpO2Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5Traditional Pulse Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5Warnings and Cautions for SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Electrodes, Leadwires, Sensors, and Sensor Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL iiElectrodes, Leadwires, Sensors and Sensor Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8Setting Up SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8Ensuring Accurate SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9SpO2 and Pulse Rate Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11Using the Sensorwatch Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12Enabling and Adjusting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Spacelabs Healthcare Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13To enable and adjust SpO2 alarms (telemetry). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Additional Information for Telemetry Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Data Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Heart Rate Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Display Details at the Host Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15Printing SpO2 Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16SpO2 Messages at the Host Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18Spacelabs Healthcare SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18SpO2 Alarm Delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19SpO2 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-204 Basic OperationsGetting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Transmitter Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Host Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Telemetry Receiver Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Assigning a Telemetry Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3Basic Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Top, Front and Bottom View (96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Rear View (96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5Front View (96281-A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6Battery Compartment (96281-A, 96281-B, 96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7Selecting Options for Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8Basic User Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9To send a recording to the central monitor or station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10To unlock the user interface on the 96281 telemetry transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10Basic Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11View Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14Status Messages at the Host Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15Telemetry Transmitter with ECG Only Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . 4-16Telemetry Transmitter with Display Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16Telemetry Transmitter with Display and SpO2 Troubleshooting Guide . . . . . . . . . . . . . . . . . . 4-175 Cleaning, Disinfecting, and SterilizationCleaning Products Not Recommended for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Cleaning the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Transmitter, Leadwires, Cables, and Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Cleaning/Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Recommended Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL iiiCleaning and Disinfecting the 96281Telemetry Transmitters and Cables . . . . . . . . . . . . . . . . . 5-2Basic Cleaning and Low-level Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Cleaning ECG Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Cleaning Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Cleaning the Battery Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3A Appendix A — Guidance and Manufacturer’s DeclarationElectromagnetic Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Electromagnetic Emmissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Table 1—Electromagnetic Emmissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2Table 2—Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2Table 2—Electromagnetic Immunity (continued) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4Table 3—Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4B Appendix B — SymbolsD R A F T 22 June 2012
D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-1IntroductionSpacelabs Healthcare patient monitoring systems demonstrate an ongoing commitment to innovation that supports decision-making and enhances patient care. Spacelabs Healthcare networking features support seamless data acquisition and data exchange across the medical enterprise, addressing the need for continuous information management. These powerful tools help you care for patients more efficiently by providing both local and remote access to patient data.About This ManualThis manual provides instruction for specific features of the Spacelabs Healthcare AriaTele™ Telemetry Transmitter (96281). It does not address system issues such as antenna infrastructure, receivers, central monitor or central station. Refer to the customer documentation for your specific telemetry receiver for information on antenna infrastructure. Refer to the customer documentation for your central monitor for information on the central monitor or station in use with the telemetry transmitter.Conventions Used in This ManualSome of the formatting conventions used in this manual are included in the list that follows. • For manuals viewed in PDF format, reference links are blue and italicized. Blue italicized typeface is a link to additional information in the manual. Hover the mouse over the blue text and click to show the topic. Reference links are located throughout the manual, including the Table of Contents.•Non-blue italicized typeface are references to information outside this manual. They may indicate references to other manuals or information which is available in another form, as identified by a title and/or a part number. Non-blue italicized typeface may also refer to error or status messages that show on the host monitor.•Bold typeface indicates text labels, phrases, or titles that show on an LCD or display which are part of a Spacelabs Healthcare software application. •Bold typeface may also indicate the formal name of graphical user interface, such as an icon or control, but which does not include a text label or title.• Terms that are ALL CAPITALIZED may represent user interface such as a key label or menu, or a status or error message on a host monitor.• Numbered steps are presented to accomplish a task. Some steps may conclude in a step result—unnumbered, indented text. Step results are shown in gray typeface. For an example of task steps, click the cross-reference To send a recording to the central monitor or station on page 4-10.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-2INTRODUCTION•Warnings, cautions, and notes are listed in the priority of the information and formatted specifically as shown below. Warnings are of the highest priority and notes are not as serious as the warnings and cautions.Warnings:Warnings indicate potentially harmful conditions that may lead to injury or death.Cautions:Cautions indicate conditions that may lead to damage to or malfunction of the device.Notes:Notes alert the user to relevant facts and conditions.Overview of the Telemetry Transmitter (96281-A/96281-B/96281-C)When worn by a patient, the 96281 telemetry transmitter acquires ECG data through electrodes attached directly to the patient’s body. Additionally, the 96281-C telemetry transmitter can acquire SpO2 data through sensors attached to the patient’s body. It transmits acquired data to the telemetry antenna infrastructure for processing by a telemetry receiver. This transmitted data may then show on a central station or bedside monitor. Refer to About the Transmitters on page 2-1 for more detailed information about each telemetry transmitter model. The 96281 telemetry transmitter does not indicate any alarm conditions. Alarms are configured, generated, and activated within the receiver-side components of the Ultraview System only.Note:SpO2 functionality is only available on the 96281-C telemetry transmitter.Manufacturer The 96281 telemetry transmitter is manufactured by: Spacelabs Medical, Inc. 5150 220th Avenue, S.E. Issaquah, Washington 98027 U.S.A. D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-3INTRODUCTIONRelationship to Other SystemsThe 96281 telemetry transmitter is related only to Spacelabs Healthcare monitoring systems. Data collected by the transmitter may be interfaced from the monitoring system to a hospital clinical information system. The telemetry transmitter is compatible with the list of receivers that follow:• Digital Telemetry System Receiver (90478) and Receiver Housing (90479-A, 90479-B, 90479-C)Refer to Patient Monitoring Operations Documents (P/N 084-1101-xx) and to the Spacelabs Healthcare Service CD (P/N 070-0700-xx) for information relating to the 90478 and 90479 digital telemetry systems.The 90478 receiver interacts with the Ultraview SL 91387-38 or 91387-39 central monitor, and with Ultraview SL patient monitors.Note:Not all products are available in all locales. Check with your local Spacelabs Healthcare representative.Intended UseThe Spacelabs Healthcare AriaTele Telemetry Transmitter (96281), when used in conjunction with a Spacelabs Healthcare Ultraview patient monitor and telemetry receiver, provides a means for the continuous collection and monitoring of electrocardiographic (ECG) signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms such as ventricular runs, tachycardia and ST-segment deviations are detected.The 96281 also provides a means for continuous collection and monitoring of SpO2.The 96281 provides an optional display intended to allow clinicians a means to view the SpO2 and pulse rate at the patient’s side. The display also provides a snapshot view of the ECG to allow the clinician to view the patient’s ECG rhythm and quality of signal.The 96281 is intended for use with either adult, pediatric or neonate populations in a healthcare facility by, or on the order of, a physician. It is not intended for home use.Indications for UseThe 96281-A and 96281-B telemetry transmitters are indicated for ECG monitoring of adult, pediatric and neonatal patients. The 96281-C telemetry transmitter is indicated for ECG and SpO2 monitoring of adult, pediatric and neonate patient populations. D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-4INTRODUCTIONWarnings, Cautions, and NotesThis chapter includes warnings, cautions, and notes specifically related to digital telemetry. Refer to the ECG chapter in the Clinical Parameters Operations Manual, P/N 070-2113-xx, for warnings and cautions and cautionary disclosures related to ECG. Refer to the product specifications chapter for warnings and cautions and cautionary disclosures that apply to electrodes and leadwires, defibrillators (including automatic implantable cardiac defibrillators), pacemakers, electrosurgical activity, several physiological parameters, or to the monitoring system itself.Obey these warnings and cautions to avoid injury or death to individuals or damage to equipment.Warnings:• Review the device prior to each and every procedure. If it shows signs of abuse then either make sure the device is repaired in an appropriate manner, serviced, or retired from use.• Medical telemetry spectrum allocations may be assigned to frequencies already allotted to other priority users. Radio frequency interference from other products may disrupt or impede telemetry patient monitoring during the life of this equipment. You are urged to regularly consult with applicable local and federal regulatory agencies (e.g., FCC, FDA) regarding the locations and frequencies of other spectrum users in your geographic area. A Spacelabs Healthcare field service engineer may be able to assist you in reconfiguring your equipment frequencies to reduce the risk of interference. Spacelabs Healthcare cannot, and does not, guarantee interference-free telemetry operation.• Telemetry systems may be more susceptible to interference than hardwired systems; this may impact signal quality.• The transmitters do not currently support inhibition of their pacer detection functionality. Since Left Ventricular Assist Devices (LVADs) can generate electromagnetic noise having similar characteristics to pacemaker artifact, users should pay particular attention to ECG traces acquired using these transmitters when an LVAD is in use.• Do not use the 96281 telemetry transmitter during magnetic resonance imaging (MRI) procedures. MRI operations will cause damage to the transmitter.• Remove the 96281 telemetry transmitter from any patient before beginning an MRI procedure. • Operation of hand-held, wireless telephone equipment (cordless telephones, cellular telephones) near telemetry systems may cause interference and should be discouraged. While personal communication devices are turned on, a separation of >2 meters (>6.5 feet) should be maintained between personal communication devices and interior walls, the patient cables, and any electronic medical device to which the patient may be connected. Patients should not use any type of electronic communication equipment while connected to any electronic medical device without an on-site evaluation by the biomedical staff. Two-way radio equipment and other personal communication devices must be evaluated on site to determine if additional space limitations are needed.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-5INTRODUCTION• The Spacelabs Healthcare digital telemetry transmitters are contra indicated for use with other medical instrumentation (e.g., respiration monitors using impedance pneumography, electrocautery) that source electrical current through the patient. Further, telemetry monitoring is contra indicated for the operating room environment.• The device should only ever be used for one patient at a time.• Opening the battery door and removing one or more of the batteries will result in the patient NOT being monitored and the ECG signal NOT being processed.•SpO2 alarms are inhibited by ECG lead-off conditions.Cautions:• This telemetry transmitter has a limited bandwidth range of 0.05 to 40 Hz, which may adversely affect the recording of high frequency components in the ECG signal, especially when the morphology of the ECG changes rapidly.• This telemetry transmitter has a limited dynamic range of +/- 4 mV, which may render the device vulnerable to saturation by ECG signals with amplitudes higher than 4 mV.• Patients should not use any type of electronic equipment (for example, portable radios, cellular telephones, pagers, personal computers) while connected to any medical electronic device without prior evaluation of that electronic equipment by the biomedical engineering staff.Notes:• Continuous monitoring of blood oxygen saturation values are only supported in conjunction with ECG monitoring. SpO2 alarms are inhibited by ECG leads-off condition.• Operation of this equipment may be subject to licensing requirements by your local telecommunications authority. Please check with your Spacelabs Healthcare field service engineer.• Spacelabs Healthcare’s telemetry equipment complies with Part 95H of the FCC Rules and with RSS-210 of Industry Canada and with requirements of other national spectrum management authorities. - Repeated here are operational cautions for biomedical telemetry from the FCC Rules (47CFR15.242(f)): “Biomedical telemetry devices must not cause harmful interference to licensed TV broadcast stations or to other authorized radio services, such as operations on the broadcast frequencies under subpart G and H of part 74 of this chapter, land mobile stations operating under part 90 of this chapter in the 470-512 MHz band, and radio astronomy operation in the 608-614 MHz band. (See section 15.5). If harmful interference occurs, the interference must either be corrected or the device must immediately cease operation on the occupied frequency. Further, the operator of the biomedical telemetry device must accept whatever level of interference is received from other radio operations. The operator, i.e., the health care facility, is responsible for resolving any interference that occurs subsequent to the installation of these devices.” - Installation of this telemetry device is permitted in hospitals and health care facilities only. This device shall not be operated in mobile vehicles (including ambulances and other vehicles associated with health care facilities). D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-6INTRODUCTION- The installer/user of a transmitter operating in the band of 608-614 MHz shall ensure that it is at least 80 km from the Dominion Radio Astrophysical Observatory (DRAO) near Pentiction, British Columbia. The coordinates of DRAO are: latitude N 49° 19’ 15”, longitude W 119°37’ 12”. For medical telemetry systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/user must coordinate with, and obtain written the concurrence of, the Director of DRAO before the equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300 (telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may be contacted.)- Transmitters operating in the bands 1395-1400 MHz or 1429-1432 MHz shall not be operated in the areas of Sydney, Nova Scotia, or Gander, Newfoundland and Labrador. Please contact the local Industry Canada Office for further information.- Transmitters operating in the bands 608-614 MHz, 1395-1400 MHz or 1429-1432 MHz comply with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.• The user of this equipment is not authorized to make any changes or alterations that could compromise the national certifications.• Operation of hand-held, wireless telephone equipment (cordless telephones, cellular telephones) near telemetry systems may cause interference and should be discouraged. While personal communication devices are turned on, a separation of >6.5 feet (>2 meters) should be maintained between personal communication devices and interior walls, the patient cables, and any electronic medical device to which the patient may be connected. Patients should not use any type of electronic communication equipment while connected to any electronic medical device without an on-site evaluation by the biomedical staff. Two-way radio equipment and other personal communication devices must be evaluated on site to determine if additional space limitations are needed.• Telemetry equipment is authorized to operate license exempt in the European Union’s (EU) Harmonized 433 to 434 MHz Short Range Device (SRD) band. Telemetry equipment operating in this band may not cause interference and must accept interference from other devices found in the band. Many countries outside the EU also permit access to this band for qualifying devices. • Operation of telemetry equipment in the 608 to 614 MHz bands (part of the Wireless Medical Telemetry Service (WMTS)) and in authorized spectrum of each country may be geographically restricted by government regulation. Operation of this equipment in all U.S. WMTS bands requires coordination and registration with the FCC-designated frequency coordinator.• Operation of telemetry equipment in the 1395 to 1400 MHz and 1429 to 1432 MHz bands (part of the Wireless Medical Telemetry Service (WMTS)) and in authorized spectrum of each country may be geographically restricted by government regulation. Operation of this equipment in all U.S. WMTS bands requires coordination and registration with the FCC-designated frequency coordinator.• Operation of this equipment may be subject to liscensing requirements by your local telecommunications authority. Check with your Spacelabs Healthcare field service engineer.• Users of medical telemetry equipment are cautioned that the operation of the equipment could result in harmful interference to other nearby medical devices.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-7INTRODUCTIONPotential UsersThe potential users of the 96281 telemetry transmitter are classified into the groups that follow.NursesNurses attach the transmitter to the patient, maintain the ECG electrodes, SpO2 sensor, and generally care for the patient. They may also admit the patient to the monitoring system and monitor the patient.Monitor TechniciansMonitor technicians may surveil patients at a central station or monitoring room configuration. Technicians may also admit patients to the system and prepare the transmitter with fresh batteries and electrodes.Biomedical EngineersA biomedical engineer, or biomed, may install, support, and repair monitoring systems, including telemetry. Biomeds may work directly for the hospital, for a third-party contract organization, or be a Spacelabs Healthcare Field Service Engineer (FSE). PhysiciansPhysicians may be common reviewers of the physiological data that is collected and subsequently presented on a monitor or at a full disclosure review station. Physicians may be responsible to treat telemetry patients, including the use of defibrillation.PatientsA telemetry patient may carry a transmitter in a gown pocket or in a pouch (the transmitter is connected to the patient by way of electrodes attached directly to the patient’s body). The patient can initiate a recording by pressing the Action button on the front of the transmitter if it is configured for this at the central station or bedside monitor. Note:The central monitor or station may be configured to ignore messages from individual telemetry transmitter units if a patient is likely to misuse this capability. Refer to the user manuals for your central monitor or station for more information. D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-8INTRODUCTIONEnvironmental ConsiderationsThe hospital environment where this product is used could contain environmental conditions that may affect the product.Since this is a wireless radio frequency (RF) device, outside interference can come from multiple sources. Even while operating within the WMTS band in North America, interference and coexistence issues may occur with other products. The device shall be sent to a separate collection facility for recovery and recycling.Refer to the data sheet for the AriaTele Transmitter (96281), P/N 061-2553-xx, for operating and storage details.Sources of InterferenceSome potential sources of interference are included in the list that follows:• Monitoring patients in elevators during transport to other units, or outside of the primary unit. Poor transmission of signals may occur. Use a monitor with a display if elevator transport is required.• Monitoring patients off the ward (radiology areas, for example) may result in poor reception due to antenna placement and wall construction.If monitoring is necessary, the augmentation of the antenna system may be required.• Defibrillation of a patient who is wearing the product. • Implanted or external pacemakers associated with a patient who is wearing the product.Potential Sources of Damage• Exposure to bodily fluids or other liquids. • The product accidentally drops onto hard surfaces, such as flooring or walls, or into sinks or toilets. • Exposure to disinfectant and various types of cleaner. Refer to Cleaning, Disinfecting, and Sterilization on page 5-1 for more detailed information.AccessoriesFor optimum performance, only use the device with recommended accessories. Refer to the data sheet AriaTele Transmitter (96281), P/N 061-2553-xx, for transmitter accessories and to the Spacelabs Healthcare Supplies and Accessories Catalog for a list of suitable electrodes and supplies from Spacelabs Healthcare. D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 1-9INTRODUCTIONRepairsTransmitters that are damaged and need repair should be sent to an authorized Spacelabs Healthcare repair depot for recovery or recycling. Check with your Spacelabs Healthcare representative for locations.D R A F T 22 June 2012
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TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-1About the TransmittersTelemetry Transmitters (96281-A, 96281-B, 96281-C)The telemetry transmitters function as part of a digital telemetry system. This system consists of transmitters, diversity antennas, receiver modules, and either a receiver housing and/or a monitor. Typically a request comes from a central host monitor to obtain data from electrodes and/or remote sensors attached to a patient which are connected to the transmitter. The central or bedside monitor tells a receiver what channel to begin listening on—one that matches the transmitter on the patient.Refer to the data sheet AriaTele Transmitter (96281), P/N 061-2553-xx, for the options available with the 96281 telemetry transmitter. Contact your Spacelabs Healthcare representative for the complete compatibility list.The patient-worn transmitters are small battery-powered devices that monitor ECG activity and SpO2 data (96281-C only) and transmit this information to the telemetry receiver module.Each transmitter only uses one channel. The wideband units transmit four leads; the narrowband units transmit two leads. The transmitters with a display show four leads. A label is affixed to each transmitter with its channel number representing a unique radio frequency. Telemetry receivers are tuned from the Spacelabs Healthcare monitor touchscreen to receive the available transmitter frequencies. 96281-A 96281-B 96281-CD R A F T 22 June 2012
ABOUT THE TRANSMITTERSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-2All transmitters are assigned a channel number at the factory. When using telemetry, the receiver must be assigned the appropriate channel for a patient at the bedside or central monitor. Admission of the patient is done at the monitor.Lead Fault IndicatorsThe 96281 transmitter has amber indicators on the front of the transmitter case. Each indicator provides the status of its respective leadwire and flashes if the leadwire is disconnected from the skin electrode or if the skin electrode makes poor electrical contact with the patient. It is possible for all lead fault indicators to flash simultaneously if all electrodes are disconnected. In addition, all indicators may flash if the transmitter is unable to determine an ECG waveform.Up to five standard, disposable, silver/silver chloride chest electrodes may be connected to the patient. The ECG leadwires are attached to these electrodes and connected to the transmitter.The 96281 telemetry transmitter is designed to operate with five patient leadwires. If you choose to use only three or four patient leadwires, patient information is still processed, but a lead fault message will show on the host monitor. An optional leadwire grouper is available for use with the ECG leadwires (refer to Figure 2-2 on page 2-3).Figure 2-1: ECG leadwire connectors and lead fault indicators (96281-C)1 Leadwire connectors2 Lead fault indicators12D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-3ABOUT THE TRANSMITTERSOptional Leadwire GrouperFigure 2-2: Leadwire grouper (front view including ECG connectors and color codes label)Figure 2-3: Leadwire grouper (rear view including clip and ECG connectors)D R A F T 22 June 2012
ABOUT THE TRANSMITTERSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-4LabelingLeadwire Color CodesBoth AHA/AAMI or IEC color codes are used on the leadwires and the transmitter labeling. The color codes for your transmitter and leadwires are based on the preference in your locale. These color variations are shown on the back label of the transmitter, front of the leadwire grouper, and on the individual ECG connectors and leadwires. This is to assist in connecting the leadwires to the correct input.1 Match the color of the ECG leadwire to the color label on the leadwires grouper2 Match the color label on the leadwires grouper to the color label on the transmitterAHA/AAMI Leadwire LabelsFigure 2-4: 5-lead AHA/AAMI color codes label on rear of transmitter Figure 2-5: 5-way AHA/AAMI label on front of grouper D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-5ABOUT THE TRANSMITTERSIEC Leadwire LabelsFigure 2-6: 5-lead IEC color codes label on rear of transmitter Figure 2-7: 5-way IEC color codes label on front of grouper Telemetry Channel LabelNote:“Ch.” refers to the channel. The label includes a barcode on the 96281 devices.Table 1: Labels for Radio Frequency ChannelsRadio Frequency (RF) Channel Label Border Color608-614 MHz433-434 MHz1395-1431.5 MHzD R A F T 22 June 2012
ABOUT THE TRANSMITTERSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-6Lead AvailabilityECG lead availability depends on which electrodes are connected to a transmitter, and whether the transmitter is a Narrowband device (option N), or a Wideband device (option W).Table 2 and Table 3 detail lead availability for narrowband and wideband transmitters, respectively, based on which electrodes are connected.Note:• Augmented leads aVR, aVL and aVF are only available at the monitor when leads I, II, and III are all available.• For optimum performance, the right leg electrode should always be connected.• If an electrode is not connected, its lead fault indicators will flash on and off at the transmitter.• If there are no leads available, all lead fault indicators will flash on and off at the transmitter.• The headings for each electrode list the AAMI and IEC lead designations (the IEC designations are in parentheses).• If a lead is not available, the monitor will either show a blank or switch to an alternate available lead.• Leads are only shown on a transmitter if the transmitter includes an optional display.• If a lead is not available, the transmitter will show a baseline trace.• Other combinations of disconnected electrodes yield no useful data, resulting in no lead availability at either the monitor or the transmitter.Table 2: Lead Availability with Narrowband transmitters (96281-xxxNx)Connected Electrodes (X)Available leads at the monitorShown leads at the transmitterRA (R)LA (L)LL (F)RL (N)V (C)X X X X X II, V I, II, III, VX X X X II, V I, II, III, VX X X X I, II, III, aVR, aVF, aVL I, II, IIIX X X I, II, III, aVR, aVF, aVL I, II, IIIX X X X III IIIX X X III IIIX X X III IIIX X III IIIX X X X II IID R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 2-7ABOUT THE TRANSMITTERSXXXII IIXXXII IIX X II IIXX XXI IXX X I IXX XI IXX I ITable 3: Lead Availability with Wideband transmitters (96281-xxxWx)Connected Electrodes (X)Available leads at the monitorShown leads at the transmitterRA (R)LA (L)LL (F)RL (N)V (C)X X X X X I,II,III,V, aVF, aVL, aVR I, II, III, VX X X X I,II,III, aVF, aVL, aVR I, II, IIIX X X X I,II,III, aVF, aVL, aVR I, II, IIIX X X X III IIIX X X III IIIX X X III IIIX X X X II IIXXXII IIXXXII IIXXX II IIXX XXI IXX XI IXX X I ITable 2: Lead Availability with Narrowband transmitters (96281-xxxNx)Connected Electrodes (X)Available leads at the monitorShown leads at the transmitterRA (R)LA (L)LL (F)RL (N)V (C)D R A F T 22 June 2012
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TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-1ECG and SpO2ECG OverviewECG monitoring begins when the system detects a signal through the connection of ECG electrodes or by installation of a battery into a telemetry transmitter. Please refer to the operations manual for your patient monitor for complete information on ECG and SpO2 setup.Telemetry ECG monitoring requires the minimum conditions from the list that follows:• ECG electrodes must be properly attached to the leadwires.• The leadwires must be properly attached to the telemetry transmitter.• The telemetry transmitter must have functional batteries.• The telemetry receiver module must be:- Inserted in the receiver housing that is connected to a central station, or- Connected to a monitor that is powered ON.- Configured to the same channel number as its corresponding telemetry transmitter. - Connected to a Spacelabs Healthcare diversity antenna.Patient Preparation and Electrode ApplicationUse silver/silver-chloride electrodes or their equivalent, and always connect all electrodes required for a particular lead. Missing electrodes may result in the loss of the ECG waveform.Note:Use only Spacelabs Healthcare-recommended electrodes. Some electrodes may polarize and create large offset potentials. This can compromise recovery time after application of defibrillator pulses. Squeeze-bulb electrodes, commonly used for diagnostic ECG recordings, may be particularly vulnerable to this effect.Noise on ECG signals, especially noise that resembles actual cardiac waveforms, is a frequent cause of false alarms. Some of this noise may be because of electrode positioning, patient movement or intermittent signal connections (either of electrode to skin or of leadwires to electrodes). You can eliminate some of this noise (and many of these false alarms) by paying careful attention to skin preparation and electrode application.The telemetry transmitter is color-coded to match the color of the leadwires. Table 1 on page 3-3 lists leadwire color and identifier codes.D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-2To Set Up ECG MonitoringWhen attaching leadwires to the telemetry transmitter, use the color coding and/or leadwire identifier code to ensure that the correct connections are made.ECG electrodes have a column of conductive gel that is surrounded by an adhesive surface. The condition of the electrode’s gel column directly affects the quality of the ECG signal. For example, more noise appears on the ECG signal if gel is displaced (or air is trapped) when you apply an electrode to the patient. Key points to remember include:• Before using electrodes, verify that they have not expired and that the conductive gel is not dry. Replace the electrodes if necessary.• Always attach the electrode to its leadwire before applying the electrode to the patient (refer to Figure 3-1). Do not apply pressure directly over the electrode’s gel column.• Press firmly around the outer edge of the electrode’s adhesive surface to ensure that the electrode is securely attached to the patient.• To minimize muscle artifact, place electrodes over flat, non-muscular areas of the body (refer to Figure 3-2). This is important for telemetry patients who are usually ambulatory.• After electrodes and leadwires are attached, add a stress loop (a loop of leadwire taped close to its electrode) to minimize stress or pulling on the electrode itself. This will improve ECG signal quality, particularly for ambulatory patients.Note:Spacelabs Healthcare recommends that electrodes be replaced after 24 to 48 hours of use.To prepare the patient• Wash the area with soap and water.• If necessary, shave the area where you plan to position the electrodes.• Clean the skin with alcohol.• Dry the skin thoroughly.• Abrade the skin.To apply ECG electrodes• Attach an electrode to a leadwire.• Apply the electrode to the patient’s skin.Figure 3-1: Electrode application1 Attach the electrode to the leadwire.2 Apply the electrode to the skin.12D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-3ECG AND SPO2Adult Electrode PlacementFigure 3-2: Adult electrode placementNote:For best ECG performance, the right leg electrode should always be connected.Table 1: Leadwire Color and Identifier CodesAAMI Electrode IdentifierAAMI Color Code Electrode PlacementIEC Electrode IdentifierIEC Color CodeRA White Right Arm R RedLA Black Left Arm L YellowLL Red Left Leg F GreenRL Green Right Leg N BlackV Brown Chest C White1RL2RA3LA 4 LL5 - 9 V1 through V65 ElectrodesI, II, III, aVR, aVL, aVF, V1 - V63254196788With 5-electrodes, one precordial lead is selected by appropriate placement of the chest (V) electrode.D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-4ECG Problem SolvingIf ECG signal quality is poor (indicated by wandering baseline, excessive noise, or muscle or respiration artifact), try the solutions from the list that follows:• Make sure that silver/silver-chloride electrodes are being used.• Make sure that the patient's skin is properly prepared.• Make sure that all electrodes are firmly attached and in good condition.• Make sure that the electrodes are positioned on a flat, non-muscular area.• Make sure that leadwires are properly fastened and in good condition.• If these actions fail to resolve the problem, select a different lead.Lead Fault IndicationThe lead fault indication messages listed here are on the central monitor/station and not the transmitter display.The message CHECK XX (where XX identifies the failed or missing electrode) appears in the ECG waveform zone if a lead fault occurs.If automatic lead switching is enabled, another lead is automatically selected so that monitoring is uninterrupted.A LEADS OFF message appears if automatic lead switching is disabled.Noise DetectionA NOISY SIGNAL message appears in the ECG waveform zone of the central monitor/station if noise is detected. If both the first and second lead are noisy, the module suspends processing temporarily. If the noise persists for 10 seconds, the system initiates an alarm. The message and alarm cease when the noise disappears.Notes:• If monitoring is interrupted because of overload or saturation of the input amplifiers, including overload caused by a defibrillator discharge, the ECG waveform is shown as an out-of-range signal accompanied by a NOISY SIGNAL or HR UNAVAILABLE message. If the overload or saturation condition persists, the ECG waveform is shown as a flat-line signal accompanied by an ASYSTOLE ALARM message.• If the waveform shown does not appear noisy, but the NOISY SIGNAL message persists, check all leads for noise before calling a qualified field service engineer.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-5ECG AND SPO2False AlarmsCareful attention to skin preparation and electrode application, especially during setup, will reduce false alarms.If false alarms occur, check for the issues from the list that follows:• Excessive noise on the signal (the most common cause of false alarms). Electrodes that are placed incorrectly over muscles, or a poor lead connection, can cause significant noise when the patient moves.• Heart rate limits set too close to patient's heart rate. Adjust the limits as necessary.SpO2OverviewPulse oximetry is used to continuously and noninvasively measure functional oxygen saturation in the blood. Pulse oximetry is measured by using changes in light absorption, as the light passes over a pulsating arteriolar bed. Pulse oximetry is also used to continuously and noninvasively measure pulse rate, using an SpO2 sensor.Note:SpO2 functionality is only available on the 96281-C telemetry transmitter.The pulse oximetry sensor contains two light-emitting diodes (LEDs). These LEDs emit specific wavelengths of red and infrared light, which are measured by a photo detector. The monitor shows this functional oxygen saturation as percent SpO2.The amount of light absorbed by the arteriolar bed varies during pulsations. During systole, a pulse of arterial blood enters the vascular bed, increasing the blood volume and light absorption. During diastole, blood volume and light absorption reach their lowest point. The pulse oximeter’s SpO2 measurement depends on the difference between the maximum and minimum absorption (systole and diastole, respectively).Traditional Pulse OximetryTraditional pulse oximetry is based on two principles:• Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry).• The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography).Traditional pulse oximetry assumes that all of the pulsations in the light absorbance signal are due to oscillations in the arterial blood volume. Therefore, the blood flow in the region of the sensor passes entirely through the capillary bed. Concentrating on the light absorption of pulsatile arterial blood eliminates the effects of non-pulsatile absorbers (such as bone, tissue, pigmentation, and venous blood), which normally absorb a constant amount of light over time.Oxyhemoglobin and deoxyhemoglobin differ in light absorption. The amount of red and infrared light absorbed by blood can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood, at each of two wavelengths (such as 660 nm and 940 nm). This ratio is translated into the functional oxygen saturation (SpO2) measurement that the monitor shows.D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-6Note:• Because SpO2 measurements depend upon light from a sensor, excessive ambient light can interfere with the pulse oximeter’s measurements.• This pulse oximeter measures functional saturation, which is essentially the percentage of hemoglobin that can transport oxygen (oxyhemoglobin). Pulse oximeters do not detect significant amounts of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, which cannot carry oxygen. Saturation measurements from pulse oximeters cannot be directly compared to measurements from a laboratory co-oximeter. Co-oximeters provide a fractional saturation (SaO2) value by measuring each type of hemoglobin individually. This fractional value is the ratio of oxygenated hemoglobin to all measured (oxygenated and dysfunctional) hemoglobins.• A pulse oximeter SpO2 measurement may not match the saturation calculated from a blood gas partial pressure of oxygen (PO2). The most likely reason is that the calculated saturation value was not corrected to reflect the effects of variables that alter the relationship of PO2 and pH. Such variables can include temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin.Refer to your hospital’s protocols for specific instructions.Warnings and Cautions for SpO2This section includes warnings and cautions specifically related to SpO2. Also included are cautionary disclosures that apply to electrodes and leadwires, defibrillators (including automatic implantable cardiac defibrillators), pacemakers, electrosurgical activity, several physiological parameters, or to the monitoring system itself.Warning:• A pulse oximeter should be considered an early warning device and should NOT be used as an apnea monitor. If a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient's condition.• Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG-based arrhythmia analysis.• Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes or any substance containing dyes that change usual arterial pigmentation may cause erroneous readings.• Inaccurate measurements may be caused by:- Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or methmoglobin).- Intravascular dyes such as indocyanine green or methylene blue.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-7ECG AND SPO2- Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material).- Venous pulsations.- Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.• Do not use the oximetry sensors during MRI scanning. Induced current could potentially cause burns. • Tissue damage can be caused by incorrect application or by wrapping the sensor too tightly for example. Inspect the sensor site as directed in the sensor directions for use to ensure skin integrity and to ensure correct positioning and adhesion of the sensor. • Applying an oximetry sensor incorrectly or leaving the sensor in place for too long may cause tissue damage, especially when monitoring neonates. • Check the sensor site frequently, and do not allow the sensor to remain on one site for too long. Refer to the instructions from the sensor manufacturer for more information.• Do not use a sensor with exposed optical components.•SpO2 functional test fixtures can not be used to assess accuracy of a pulse oximeter sensor or monitor.Electrodes, Leadwires, Sensors, and Sensor CablesWarnings:• Carefully route all cables between the patient and the monitor to reduce the possibility of patient entanglement or strangulation.• Signals resulting from devices such as Implantable Cardiac Defibrillators (ICD) may momentarily blank the ECG waveform rather than show an out-of-range signal. In such cases it may not be apparent that the ICD has triggered and the condition of the patient should be checked. In all instances of the ICD being triggered, the monitor will reshow the ECG waveform within five seconds.• ECG alarms for ventricular fibrillation and asystole remain active while the patient’s rate and morphology are being learned (for example, following a lead switch or use of the RELEARN feature). ECG alarms for high rate, low rate, ventricular run, couplet, VE/minute, atrial fibrillation, pause, and PSVT are not reactivated until the learning process ends.• To ensure against any possibility of electric shock, do not touch lead electrodes or the monitor during defibrillation.D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-8Electrodes, Leadwires, Sensors and Sensor CablesCautions:• Visually inspect each leadwire for obvious damage and replace as needed.• Use only patient cables and leadwires specified by Spacelabs Healthcare. Other cables and leadwires may damage the monitor during defibrillation and may also change the required input impedance and DC offset voltage, affecting performance.• Do not use stainless steel electrodes.• Do not allow conductive parts of electrode leads or connectors, including the neutral electrode, to contact other conductive parts, including the ground.• Use only patient sensors specified by Spacelabs Healthcare. If you use sensors other than those specified, it may degrade SpO2 performance and could damage the monitor during defibrillation.• Spacelabs Healthcare recommends the use of sensors repaired or remanufactured by the original manufacturer only.• Never attach an SpO2 sensor to a limb being monitored with a blood pressure cuff or a limb with restricted blood flow.• A poorly applied sensor may give incorrect saturation values. The Sensorwatch signal-strength indicator is used to identify a poorly applied sensor or a poorly chosen site. Refer to Using the Sensorwatch Feature on page 3-12 for additional information.• Choose a site with sufficient perfusion to ensure accurate oximetry values.• An adapter cable is required between the sensor and the transmitter. Do not discard the adapter cable when you have finished using a disposable oximetry sensor. Disconnect the sensor cable from the adapter cable before discarding the sensor.Note:For cleaning and disinfecting procedures, refer to the Cleaning, Disinfecting, and Sterilization chapter of this manual.Setting Up SpO2 Monitoring1Connect the SpO2 adapter cable to the patient-worn telemetry transmitter.2Attach the sensor to the patient and connect the sensor cable to the SpO2 adapter cable.3Initiate ECG monitoring on the patient monitor.4Touch ECG.5Touch CHANNEL FORMAT.6Touch SpO2/ON.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-9ECG AND SPO2Ensuring Accurate SpO2 MonitoringEach sensor requires site-specific application procedures. The quality of the patient’s pulse oximetry measurements and pulse signals may be adversely affected by certain environmental factors, by oximetry sensor application errors, and by patient conditions. Any of these factors can interfere with the monitor’s ability to detect and show measurements and may result in a loss-of-pulse condition. If the SpO2 measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper operation.Patients with anemia and/or significant concentrations of dysfunctional hemoglobins (such as carboxyhemoglobin, methemoglobin, and sulphemoglobin) may appear to have normal saturation values while actually being hypoxic. Further assessment, using means other than pulse oximetry, is recommended for such patients.• For anemic patients, this condition occurs because patients have decreased arterial oxygen contents.• For patients with dysfunctional hemoglobins (that are unable to carry oxygen), this condition occurs because less functional hemoglobin is available to carry oxygen. Caution:Hemoglobin levels below 5 g/dl may prevent the monitor from providing SpO2 values.Other patient conditions that may result in inaccurate measurements or a loss-of-signal condition during operation include:• Low perfusion• Dark pigment• Prolonged and/or excessive patient movement• An arterial occlusion (blocked artery) proximal to the sensor• Venous pulsations• Wrapping the sensor too tightly around the patient’s digit or other extremity• Placing the sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line• Inflating a blood pressure cuff on the limb to which the sensor is attachedExternal factors that may adversely affect the accuracy of oximetry readings include:• High ambient lighting• High-frequency electrical noise, such as electrosurgical units and defibrillators• The presence of intravascular dyes, such as indocyanine green or methylene blue, or externally applied coloring, such as nail polish or pigmented creams• The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia• The patient is in cardiac arrest or is in shockD R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-10Caution:Sources of high ambient light such as direct sunlight, surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, and infrared heating lamps can interfere with an SpO2 sensor’s performance and result in inaccurate measurements. When using SpO2 under such conditions, this interference can be reduced by covering the application site with an opaque material and by ensuring that the sensor is properly applied.Taking the actions that follow may improve SpO2 performance:• Select an application site with unrestricted blood flow.• Do not select a site near potential electrical interference (e.g., electronic equipment, electrosurgical units, other power cords). If possible, remove these electrical noise sources from the area.• If artificial nails or externally applied coloring agents such as nail polish are present, select another site or remove the polish/artificial nails.• If necessary, wipe the sensor site for 20 to 30 seconds with a 70% isopropyl alcohol pad to improve performance.• Apply the sensor correctly, ensuring that the LEDs and the photo detector are properly aligned directly opposite each other, preferably on a site that minimizes the distance between the emitter and photodetector. Periodically check to ensure that the sensor remains properly positioned on the patient.• Do not restrict blood flow when securing a sensor with tape.• If high ambient light is affecting measurements, ensure that the sensor is properly applied and then cover the application site with an opaque material such as a blanket or towel. Failure to do this may result in inaccurate measurements.• Maintain a minimum signal level above the Sensorwatch bar.If patient movement presents a problem, one or more of the actions that follow may correct it:• Verify that the sensor is properly and securely applied.• Move the sensor to a less active site; to reduce or eliminate motion artifact, the application site should remain as immobile as possible.• Use an adhesive sensor that tolerates some patient motion.• Use a new sensor with fresh adhesive backing.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-11ECG AND SPO2SpO2 and Pulse Rate SpecificationsDisplayed RangeSpO2 (functional) 0% - 100%Pulse Rate (bpm) 30- 240 bpmResolutionSpO2 (functional) 1%Pulse Rate (bpm) 1 bpm Table 2: Pediatric or Adult SpO2 and Pulse Rate AccuracyParameter Patient Type Signal Condition Range AccuracySpO2 (functional) Pediatric or Adult No motion and normal perfusion70-1000-69+/- 2% unspecifiedPulse Rate (bpm) Pediatric or Adult No motion and normal perfusion 30-240 +/- 3 bpmTable 3: Neonate SpO2 and Pulse Rate AccuracyParameter Patient Type Signal Condition Range AccuracySpO2 (functional) Neonate No motion and normal perfusion70-1000-69+/- 3.25% unspecifiedPulse Rate (bpm) Neonate No motion and normal perfusion 30-240 +/- 3 bpmD R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-12Using the Sensorwatch FeatureThe Sensorwatch feature provides a graphical presentation of the amplitude of the signal received from the sensor. It can be used to determine the best sensor site and application.Figure 3-3: SpO2 Sensorwatch bar on the 91387-38 central monitorFigure 3-4: SpO2 Sensorwatch symbol on the 96281-C telemetry transmitter. Changes in the bar’s shaded level signify changes in the patient’s perfusion or changes in the application of the sensor. The horizontal line in the bottom fourth of the bar is used in Spacelabs Healthcare SpO2 technology only and represents the minimum signal level that results in accurate saturation values.When the shading is just below this line, the message LOW SIGNAL STRENGTH - Reposition or replace sensor appears.• Reposition the sensor to a different site to provide better perfusion.• Reposition the sensor to provide better contact with the skin. Make sure the LEDs and photo detector are properly aligned.• Replace a defective sensor.• Wait for the patient to warm up and for the patient’s perfusion to increase.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-13ECG AND SPO2Enabling and Adjusting Alarms Spacelabs Healthcare TechnologyPulse oximetry alarm limits and delays are set internally based upon defined default values. Refer to the user manuals for your patient monitor for details on operating system alarms.To enable and adjust SpO2 alarms (telemetry)1Touch ECG. 2Touch ALARM LIMITS.3Touch SPO2 ALARM LIMITS.4Select SPO2 ALM / ON. 5Select HI=, LO=, ALM DELAY, or MSG ALARM DELAY (if present).6Use the arrow keys to adjust.Additional Information for Telemetry ProductsWhen SpO2 alarms are enabled, a bell symbol appears immediately after the measured SpO2saturation percentage (%).Data AveragingData averaging is performed internally on the telemetry transmitter. The data averaging feature smooths the oximetry saturation value by averaging patient input values over several seconds. TelemetryFor telemetry monitoring, the heart rate for the display is obtained directly from the acquired ECG leads. In addition, the pulse rate is obtained from the SpO2 parameter. SpO2 pulse rate is viewable in the patient’s trends and on the 96281-C telemetry transmitter.Heart Rate AveragingOn-Transmitter Heart Rate Display PerformanceThe 96281-B and 96281-C transmitters can show the patient’s heart rate when the transmitter is in view mode. The heart rate shown on the transmitter is to aid patient hook up and is indicative only; it is not for diagnostic use. The heart rate shown on the transmitter is not related to the heart rate shown on any central monitor/station. The heart rate is calculated using the QRS complexes detected within the last five seconds on ECG data. Averaging is performed within the five second window. The heart rate shown on the screen is updated approximately every 1.8 seconds.D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-14The on-transmitter heart rate display has been tested according to IEC 60601-2-27:2011 for:• Tall T-wave rejection: It rejects T-waves up to 150% of the QRS complex amplitude,• Maximum response times, to the nearest second, to step changes in heart rates:- 5 seconds when the heart rate changes from 80 beats per minute to 120 beats per minute.- 5 seconds when the heart rate changes from 80 beats per minute to 40 beats per minute.• Heart rate accuracy and response to irregular rhythms:The heart rates that show on the display for the four irregular rhythm test waveforms within the standard are listed in Table 4. Warning:The on-transmitter heart rate display accuracy may be affected by cardiac arrhythmias and pacemaker pulses. The heart rate shown on a central station or bedside monitor may similarly be affected. Refer to their manuals for appropriate details.Note:The on-transmitter heart rate is calculated using ECG Lead II only, consequently if either RA or LL electrode is not present, then heart rate cannot be calculated and ??? will be shown on the transmitter display.Table 4: Heart Rates for Four Irregular Rhythm Test WaveformsTest Waveform Heart Rate Shown on MonitorA1 80A2 63A3 119A4 86D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-15ECG AND SPO2Display Details at the Host MonitorSignal detection is indicated on your monitor when an ECG signal appears next to the ECG parameter key in the zone assigned to receive the transmitted telemetry channel. The transmitter's channel number is always identified above the waveform, to the left of the ECG key.Figure 3-5: Central monitor — split view (SpO2 turned ON)Notes:•SpO2 does not show if it is turned OFF.• A bell symbol follows the percent (%) symbol if the SpO2 alarm is enabled.1 Current heart rate2 Abnormal beats per minute counter 3 ECG lead designator4 SpO2 reading5 Telemetry channel number6 ECG rate alarm limits. Split-view central monitors show a bell symbol when alarms are enabled.7 Sensorwatch signal strength indicatorShaded area (waveform index, WFI) expands up proportionally to signal strength; horizontal line indicates minimum signal level.No shading (lowest waveform index) corresponds to no detected signal strength or a faulty sensor.8 ECG key for first lead9 Bed/patient ID10 ECG waveform for first lead1234 5 6 7 8HR=70 A=3 II 98% 2241ECGBED 01910D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-16Printing SpO2 WaveformsThis feature is not supported in telemetry products.SpO2 Messages at the Host MonitorCaution:Status messages indicate problems or conditions that may affect accurate monitoring values. Do not ignore these messages. Correct any fault before continuing.When a status message appears, the saturation value and pulse rate immediately change to ???. An alarm may occur if your module is configured to do so. Depending on the configuration and option purchased, this alarm may not occur until after the message alarm delay time has elapsed.Telemetry products use different text for SpO2 status messages than non-telemetry products. Telemetry products also show status messages within the ECG display zone, therefore, the ECG alarm messages that follow take priority over other SpO2 messages.•LEADS OFF• NOISY SIGNAL• ECG ALARMS SUSPENDEDRefer to the customer documentation for your monitor for complete information on potential status messages which may appear at a host monitor that is configured with a 96281-A, 96281-B, 96281-C telemetry transmitter.When a status message appears, the saturation value and pulse rate immediately change to ???. An alarm may occur if your module is configured to do so. Depending on the configuration and option purchased, this alarm may not occur until after the message alarm delay time has elapsed.Telemetry products use different text for SpO2 status messages than non-telemetry products. Refer to Table 5 for interpretations of the telemetry messages.Telemetry products also show status messages within the ECG display zone, therefore, the ECG alarm messages that follow take priority over other SpO2 messages.•LEADS OFF• NOISY SIGNAL• ECG ALARMS SUSPENDEDTable 5: Telemetry Message EquivalentsTelemetry SpO2 MessageSPO2 SENSOR DISCONNECTEDSPO2 FAULTY SENSORSPO2 SENSOR DISCONNECTEDD R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-17ECG AND SPO2SENSOR DISCONNECTED — Check connection at adapter cableThis message and alarm indicate that the sensor is either disconnected or the wiring is faulty.• Check for proper sensor connection to the adapter cable.• If the message persists, replace the sensor and/or the adapter cable.SENSOR OFF PATIENT — Check connection at patient• The telemetry transmitter does not detect a valid sensor input signal. Check the patient for proper sensor placement.• The tissue between the LED and photodiode is too transmissive. If the sensor placement seems correct and the message persists, try a sensor site with a thicker tissue bed.Note:This message is not available with all SpO2 sensors.INSUFFICIENT SIGNAL — Reposition or replace sensor• Insufficient signal for proper operation, indicated by a low deflection on the Sensorwatch signal strength bar.• Poor sensor application or site. Correctly reapply or reposition to a better perfused site, or massage the site.• If the message persists, then replace the sensor.LOW SIGNAL STRENGTH — Reposition or replace sensorWhen this message appears, the saturation and pulse rate continue to show. However, the Sensorwatch bar flashes as an indication of a possible error condition.• Insufficient blood flow between the sensor light emitter and detector. Move the sensor to an area of higher perfusion.• Poor sensor application. Reposition to place active components closer to the skin or locate to a better perfused site.• The sensor site is below the blood pressure cuff. Move to another site.• If the message persists, then replace the sensor.SPO2 SENSOR OFF PATIENTSPO2 INSUFFICIENT SIGNALSPO2 AMBIENT LIGHT INTF.SPO2 NOISY SIGNALSPO2 INSUFFICIENT SIGNALTable 5: Telemetry Message Equivalents (continued)Telemetry SpO2 MessageD R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-18AMBIENT LIGHT INTERFERENCE — Cover sensor area • The sensor is receiving external light interference from a bright light source near the sensor. Shield the sensor from the external light source.• The sensor photodiode and LED are misaligned on flexible sensors, allowing light to enter. Realign the sensor photodiode with the LED.• If the message persists, then replace the sensor.NOISY SIGNAL• The sensor signal is disturbed by motion or other interference. Eliminate sensor movement.• Power cords or other electrically noisy devices are too close to the sensor. Move the noisy device or move the sensor to another site.• If the message persists, then replace the sensor.FAULTY SENSOR — Replace sensor• The LED or photodiode (or both) may have failed.• Ensure the sensor is properly connected, disconnect and then reconnect the sensor.• If the error occurs again, replace the sensor and/or sensor adapter cable.• If replacing the sensor and/or cable does not correct the problem, contact your Spacelabs Healthcare Field Service Engineer.HARDWARE INCOMPATIBILITY — Contact serviceThe hardware configuration in your module is not compatible with the programmed software options.• Contact your Spacelabs Healthcare Field Service Engineer.SensorsFor SpO2 sensor compatibility, refer to the information that follows.Spacelabs Healthcare SpO2 SensorsPlease refer to the the accessories in Telemetry Transmitter (96281) Data Sheet for compatible sensors (for the 96281-C) and adapter cables.Additional InformationFor additional information about biocompatibility or sensor disposal, refer to the manufacturer's instructions enclosed with each sensor.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-19ECG AND SPO2SpO2 Alarm DelaysTable 6: SpO2 AlarmsAlarm Setting Range Alarm DelaySpacelabs HealthcareSat Low 50 to 99%• Less than (15 seconds + user selected alarm delay) • Alarm delay is user selected from 0 to 30 seconds in 5 second increments.Sat High 51 to 100%• Less than (20 seconds + user selected alarm delay)• Alarm delay is user selected from 0 to 30 seconds in 5 second increments.D R A F T 22 June 2012
ECG AND SPO2TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-20SpO2 Troubleshooting GuideClinical Situation Possible Cause SolutionNo SpO2 parameter key in Channel Format menu•SpO2 is not enabled at the 90478 receiver.• Enable multiparameter telemetry in the Module Configuration Manager or enable the SpO2 display in the Channel Format menu.SpO2 value shows as ??? • Sensor is not connected to the patient.• Reattach the sensor.• There is excessive patient motion.• Request patient to remain still while reading is in progress.• Module is in the initialization phase (the first 15 seconds after sensor application).• Wait until the initialization is complete.• Adapter cable is improperly connected to the telemetry transmitter.• Correctly connect the adapter cable.• Sensor is not connected to the adapter cable.• Correctly connect the sensor.• Telemetry low battery indicator is constantly illuminated.• Contact your biomed or a qualified field service engineer.Low signal strength-OR-Insufficient Signal• Sensor placement is not optimum.• Move the sensor to a site which has better perfusion.• Align the LED with the sensor photo detector.• Sensor is placed below the blood pressure cuff.• Move the sensor to an alternate limb.Intermittent or complete failure to operate• Receiver or transmitter error. • Contact your biomed or a qualified field service engineer.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 3-21ECG AND SPO2Factors causing significant variances in sensor accuracy• Presence of dysfunctional hemoglobins (COHb, MetHb).• Follow hospital procedure for determining oxygenation in these patients.• Presence of intravascular dyes (indocyamine green, methylene blue) in the blood stream.• Follow hospital procedure for determining oxygenation in these patients.• High ambient light level. • Reduce light levels near the patient.• Electrosurgical interference. • Follow hospital procedure for determining oxygenation in these patients.• Patient is significantly anemic (Hb less than 5 g/dl) or has received large amounts of IV solutions.• Follow hospital procedure for determining oxygenation in these patients.No SpO2 alarms are shown • ECG “Leads Off” condition exists.• Re-attach ECG leadwires to the patient and resume ECG monitoring.• Higher priority alarm condition is present.• Clear the current alarm condition and/or re-prioritize SpO2 alarms in the Module Configuration Manager.• When SpO2 alarms are ON, all SpO2 alarm conditions cause the parameter value to blink according to the alarm priority set using the Module Configuration Manager.FAULTY SENSORReplace Sensor• A faulty or incompatible sensor is connected to the adapter cable.• To clear the message, connect a known good sensor to the adapter cable.• Sensor has failed.Clinical Situation Possible Cause SolutionD R A F T 22 June 2012
D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-1Basic OperationsGetting StartedDevice setup must be performed before patient application and, on appropriate units, the LCD should be visually verified to function before use on a patient.Transmitter BatteriesWhen batteries are installed, the transmitter is continuously ON. If no batteries are installed, the transmitter is OFF. To extend battery life, insert batteries only to use the transmitter with a patient. Remove the batteries when the transmitter is not in use. Spacelabs Healthcare recommends two AA 1.5-volt alkaline batteries for standard use in the digital telemetry transmitter for a battery source of 3 volts. Alternatively, you may use two AA-equivalent 2400 mAH NiMH rechargeable batteries.Check the battery position and polarity, as shown at the bottom of the battery compartment on the device. After battery installation, close and latch the compartment cover. Transmission of telemetry signals begin as soon as the battery is in place.Refer to Battery Compartment (96281-A, 96281-B, 96281-C) on page 4-7 for details on battery compartment labels and components.Warnings:• Batteries exposed to short circuit, high temperature, or fire may leak, vent, or explode.• Do not use any transmitter that has been compromised by liquid ingress.• Do not allow any liquid to enter the case. An open battery compartment is not fluid resistant.• Users should inspect batteries before using them within the transmitter- do not use any batteries that appear to be damaged or have been subject to misuse.• Do not attempt to use depleted batteries or mix different types of batteries. Doing so may result in the telemetry transmitter being unable to accurately determine the battery condition and prevent the transmitter from working properly. If the battery low indicator flashes as soon as batteries are inserted, then they are too depleted to be used and the transmitter will not work properly. Replace with new or fully-charged batteries immediately.Cautions:• Obey the battery manufacturer’s recommended handling procedure. • Collect and transport batteries in a manner that prevents short circuit, compacting, mutilation, or any other abuse that would compromise the physical integrity.D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-2• Clean the transmitter case with the battery door closed. • Inspect and check the transmitter for damage prior to every procedure.• Use either new alkaline batteries or fully-charged 2400 mAH NiMH rechargeable batteries for each and every new procedure.• Clean the transmitter after each use. Refer to the Telemetry Transmitter (96281-A, 96281-B, 96281-C) Service Manual (P/N 070-2408-xx), located on the Telemetry Service (9628X) CD (P/N 084-2202-xx) for preventive maintenance instructions.• Make sure that service on the transmitter is performed by authorized Spacelabs Healthcare service personnel when repairs are necessary or at suitable intervals.Notes:The description that follows of transmitter operation is valid only for two AA 1.5-volt alkaline or two AA-equivalent 2400 mAH NiMH rechargeable batteries and does not apply to any other type of battery.• When a low battery condition is detected, the orange battery status indicator illuminates on the front cover of all three transmitter models: 96281-A, 96281-B, 96281-C. In addition, a red battery symbol appears in the display of the 96281-B and 96281-C transmitters. • Used batteries must be properly disposed of or recycled according to national and/or local regulation.• Refer to the product service manual for more details.Host MonitorsThe 96281 telemetry transmitter is compatible with the Ultraview SL 3800-38/-39 central monitor and the Ultraview and Ultraview SL line of bedside monitors. For information on configuring battery alarm status, enabling and adjusting alarms, assigning telemetry channels, status or interference messages, refer to the operations and service manuals for the specific monitor in use with the telemetry transmitter devices.If you use Ultraview SL 3800-38 or 3800-39 central monitor,• refer to the Ultraview SL Operations Manual (P/N 070-1150-xx), 91387 Service Manual (P/N 070-1159-xx), and to the Clinical Parameters Operations Manual (P/N 070-2113-xx) for more information.Telemetry Receiver ModuleThe telemetry transmitters are compatible with the 90478 Digital Telemetry System Receiver and Receiver Housing (90479-A, 90479-B, 90479-C). The receiver housing is related to the central monitor. The receiver module can go in the housing or in a bedside monitor.Refer to Clinical Parameters Operations Manual (P/N 070-2113-xx) located on the Patient Monitoring Operations Documents CD (P/N 084-1101-xx) and to the Spacelabs Healthcare Service CD (P/N 070-0700-xx) for detailed information relating to the 90478 and 90479 digital telemetry systems.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-3BASIC OPERATIONSWarning:All system connections (except for those related to moving receivers from one monitor or housing to another) must be made by trained or qualified personnel only. Changes or modifications not expressly approved by Spacelabs Healthcare may void the user’s authority to operate the equipment. Cautions:• Telemetry transmitters have preassigned channel numbers (frequencies) that cannot be changed. The channel number is identified on the back cover of the transmitter.• Only qualified personnel should tune telemetry receiver modules to receive data from a telemetry transmitter. Telemetry receiver modules must be used with a transmitter on the same frequency.• Qualified service personnel should set the telemetry receiver’s frequency band via the Module Configuration Manager feature.Assigning a Telemetry ChannelWhen connecting a new patient to a transmitter, make sure the prior patient’s information has been purged at the host monitor.Your central station can only show a telemetry channel after that channel has been assigned a specific bed or room number. Refer to the user manuals for your central monitor or station for information to assign a specific bed name to a telemetry channel and to assign the bed to a specific display zone. Your central monitor can be configured to remember the bed name assigned to individual telemetry channels. These beds are permanently assigned until you unassign or reassign them. Refer to the Ultraview SL Module Configuration Manager System Administration Guide (P/N 070-1245-xx) for more information.Basic ComponentsThe 96281-B telemetry transmitter is essentially the same as the 96281-C model, except for the SpO2capability. Thus the components described in the illustrations of the 96281-C are also applicable to the 96281-B model except for the SpO2 connector cap. The 96281-A model is similar to the 96281-B and 96281-C but it does not include a display or an SpO2 connector cap or functionality (refer to Figure 4-3 on page 4-6).D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-4Top, Front and Bottom View (96281-C)Figure 4-1: Top, front, and bottom views (96281-C)1 Top view showing lead inputs and SPO2 connector cap (SPO2 cap on 96281-C only)2 Front view of SPO2 connector cap (96281-C only)3 Location on display where lead fault indicators show (96281-B, 96281-C)4 Action buttonNote:The nurse may instruct the patient to press the Action button if he or she experiences any discomfort.5 Low battery indicator1345762D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-5BASIC OPERATIONS6 Bottom view of the battery compartment latch7 Up/down buttons for LCD configuration (96281-B and 96281-C only)Rear View (96281-C)Figure 4-2: Rear view (96281-C)1 Grouper (includes a clip)2 “Do not modify” symbol (repairs and modifications must be done by Spacelabs Healthcare, or the warranty is void)3 ECG label (includes lead legend and leads placement diagram)4 Channel identifier5 Manufacturing technical label6 Battery compartment cover123456D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-6Front View (96281-A)Figure 4-3: 96281-A Telemetry Transmitter1 Lead fault indicators on 96281-A (up to five triangular shapes may illuminate when activated by a lead off condition)2 Action button3 Low battery indicator123D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-7BASIC OPERATIONSBattery Compartment (96281-A, 96281-B, 96281-C)Figure 4-4: Details of battery compartment (cover open)1 Battery type label affixed to underside of open battery compartment cover2 Battery polarity label3 Battery compartment latch (on bottomside)123D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-8Selecting Options for LeadsUp to five standard, disposable, silver/silver chloride chest electrodes are connected to the patient. The ECG leadwires are attached to these electrodes and connected to the transmitter. Refer to Figure 4-5 on page 4-8 for leads placement and SpO2 connections.Figure 4-5: ECG leads placement and SpO2 connections1 RA2 LA3 V4 LL5 RL6 96281-C telemetry transmitter7 SpO2 sensor8 SpO2 cableMonitors and transmitters may be placed in pouches and attached to the patient’s belt.12346578D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-9BASIC OPERATIONSNotes:• If one of the leads fails, a lead fault message shows on the host monitor. • If there is no valid lead vector, the message CHAN 1 & 2 - LEADS OFF shows and an alarm tone sounds only at the host monitor.Basic User ActionsThe up and down arrow buttons (refer to 6 in Figure 4-1 on page 4-4) provide navigational control, such as moving through ECG and SpO2 displays. These up/down buttons are only included on the 96281-B and 96281-C models.All 96281 devices include the Action button, refer to item 4 in Figure 4-1 on page 4-4. If a patient or user presses this button, and keeps the button pressed for approximately one and a half seconds, the transmitter sends an “event” to the host monitor. The transmitter provides visual indication of such “events” by flashing all its LEAD OFF indicators on-off, on-off, twice in quick succession. The corresponding action at the host monitor, depends on the configuration settings of the host monitor, so please refer to the Monitor Operations Manual, but typically events are used to generate strip recordings.Warnings:• Do not use any transmitter that has been compromised by liquid ingress.• Do not allow liquid to enter the battery compartment.• Readings for SpO2 should not be taken from the same arm that has an NIBP cuff attached.Cautions:• Clean the transmitter case with the battery door closed. Fluids, including cleaning solutions, may damage the electrical components inside and cause the transmitter to malfunction.• Clean the transmitter after every procedure (refer to Cleaning, Disinfecting, and Sterilization on page 5-1 for more information).Notes:• Should all of the lead fault indicators illuminate and stay illuminated during operation, then the AriaTele transmitter has detected an internal fault condition. If this occurs, the device will stop transmitting and will not show any ECG or SpO2 information. To clear this condition, install new batteries.• If all of the lead fault indicators remain permanently illuminated, please contact your Spacelabs Healthcare service representative for assistance.D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-10To send a recording to the central monitor or station• From either the view or non-view mode, firmly push the action button for 2 seconds. Refer to Basic Modes of Operation on page 4-11 for more information. Note:The record function must be enabled at the central station to send a recording. Refer to the operations manual for your central station for more information.To unlock the user interface on the 96281 telemetry transmitter•Push and hold the up and down buttons simultaneously for at least three seconds.Note:When the user interface is locked, the LCD appears blank, even though the transmitter is in a non-view mode and still transmitting.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-11BASIC OPERATIONSBasic Modes of OperationThere are three basic operating modes to the telemetry transmitter.1 Off2 View3 Non-ViewNote:The 96281-C automatically detects a sensor connection and activates or deactivates the SpO2 option accordingly.Table 1: Basic Modes of OperationOperating Mode DescriptionOff The device is off and is not in use if there are no batteries installed.View96281-B, 96281-C1 User can view patient vital signs on the host monitor or transmitter LCD.2 User can initiate printing.3 Patient vital signs are transmitted to the central station.After 60 seconds of inactivity, the unit moves to the non-view mode.Non-View96281-A, 96281-B, 96281-CNote:Since the 96281-A does not have an LCD, it is either continuously in non-view mode or is OFF.1 The LCD is off on the 96281-B or 96281-C.2 User can initiate printing.3 Patient vital signs are transmitted to the central station.4 User can return to the view mode by unlocking the user interface (96281-B or 96281-C only). To unlock the interface, push and hold the up and down buttons simultaneously for at least three seconds.D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-12View ModeView Mode is available only with transmitters that include a display (96281-B or 96281-C), so it is not applicable to the 96281-A telemetry transmitter.ECGECG data is obtained directly from the patient connection and shows on the transmitter LCD as shown in Figure 4-6, depending on configuration of leads and available parameters.Figure 4-6: Paced ECG and SpO2 display on the 96281-C1 SpO2 saturation percentage (available on 96281-C only)2 ECG waveform3 Battery charge indicator (shows the battery state)4 Pacing marker5 Shown lead indicator6 Heart rate derived from ECG (indicated by solid heart icon)Note: The AriaTele acquires and transmits ECG data in samples. In addition, it may show the ECG waveform on its optional display. When the AriaTele acquires an ECG sample that it detects as possessing a pacing pulse, it does two things: 1235 64D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-13BASIC OPERATIONS• It sends a notification to the receiving system, indicating that the ECG sample contained a pacing pulse.• It marks the location of the pacing pulse, on its optional display, using purple pacing markers as shown.The receiver system uses the information it receives to mark corresponding purple pacing pulses on the ECG waveform that it receives.Note:• ECG leads show in the order that follows: Lead II, V, Lead I, Lead III. • If a lead is not available due to electrode configuration, that lead shows as a straight line on the display.• Pacing marker (shows only if detected) is shown as a vertical purple line.The symbols that follow show on the 96281-B and 96281-C telemetry transmitter LCD when numerics are not available or are out of the designated range for a parameter. Not available ???Under range - - -Over range +++D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-14SpO2SpO2 is only available with the 96281-C. SpO2 data is obtained directly from the patient and may show as in Figure 4-7, depending on configuration of leads and available parameters. The 96281-C auto-detects a sensor connection and activates or deactivates the SpO2 option accordingly.Note:SpO2 view does not show if a SpO2 adapter cable is not connected.Figure 4-7: Typical SpO2 display on 96281-C (shows a low battery state)1 SpO2 saturation percentage (96281-C only)2 SpO2 pulse waveform (96281-C only)3 Battery charge indicator (defined by quartiles)4 Signal quality/strength indicator (at least one color bar in the indicator is recommended for a reliable SpO2 value)5 Pulse rate derived from SpO2 (indicated by an asterisk) 41253D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-15BASIC OPERATIONSStatus Messages at the Host MonitorVarious status messages related to the telemetry transmitter may show at the host monitor when there is a problem with the signal or when the battery is low. The host monitor may be either the central station or bedside monitor. Caution:• Do not ignore status messages.•SpO2 data may not show when the INTERMITTENT SIGNAL LOSS message appears.• Status messages indicate a problem or condition which may affect accurate monitoring values. • Correct any fault before continuing.The status messages that follow may appear at the host monitor. Refer to SpO2 Messages at the Host Monitor on page 3-16, for status messages related to SpO2.• INTERMITTENT SIGNAL LOSSIndicates that the patient may be out of antenna range or the battery is depleted. Return the patient into antenna range. Check that the battery is functioning properly. A low-priority alarm occurs after 10 seconds in this condition.• LOW BATTERYIndicates the battery is weak. After this message appears, the battery has approximately one hour of useful life left (depending on the type of battery used). Install a new battery. A low-priority alarm occurs if the setup menu’s LOW BAT ON/OFF key is set to ON.• SIGNAL INTERFERENCEIndicates, through the triangle-shaped squelch waveform, that an interfering signal has been detected. The patient’s signal can no longer be detected because of interference from a stronger signal source lasting more than 0.5 seconds. A low priority alarm occurs whenever this message appears in the waveform zone.•IS SIGNAL LOSS PERMANENT? Indicates no radio frequency (RF) signal is detected.D R A F T 22 June 2012
BASIC OPERATIONSTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-16Telemetry Transmitter with ECG Only Troubleshooting GuideClinical Situation Possible Cause SolutionLow battery LED flashing• The batteries are low. • Replace batteries.All leads off LEDs lit • Self test failure. • Contact Spacelabs Healthcare.Any or all leads off LEDs flashing• Check ECG leads.ECG is not shown at Central Station• Check if batteries are low. • Replace batteries.ECG is not shown at Central Station• Unit malfunction. • Contact Spacelabs Healthcare.Telemetry Transmitter with Display Troubleshooting GuideClinical Situation Possible Cause SolutionLow battery LED flashing• The batteries are low. • Replace batteries.All leads off LEDs lit • Self test failure. • Contact Spacelabs Healthcare.Any or all leads off LEDs flashing• Check ECG leads.ECG is not shown at Central Station• Check if batteries are low. • Replace batteries.ECG is not shown on transmitter display• Unit malfunction. • Contact Spacelabs Healthcare.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 4-17BASIC OPERATIONSTelemetry Transmitter with Display and SpO2 Troubleshooting GuideClinical Situation Possible Cause SolutionLow battery LED flashing• The batteries are low. • Replace batteries.All leads off LEDs lit • Self test failure. • Contact Spacelabs Healthcare.Any or all leads off LEDs flashing• Check ECG leads.ECG is not shown at Central Station• Check if batteries are low. • Replace batteries.SpO2 data is not shown on transmitter display•SpO2 cable and/or sensor is faulty.• Unit malfunction.•Check SpO2 cable and sensor.• Contact Spacelabs Healthcare.SpO2 is not shown at Central Station• Unit malfunction. • Contact Spacelabs Healthcare.D R A F T 22 June 2012
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TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 5-1Cleaning, Disinfecting, and SterilizationCleaning Products Not Recommended for UseWarnings:• Do not use Accelerated Hydrogen Peroxide (AHP) and quaternary ammonia-based products to clean the transmitter, leadwires, cables, or sensors. Common quaternary ammonia germicidal products include Cavicide, Virex, Virex 256, SaniCloth, and Sanicloth Plus. • These chemicals attack the plastics used in patient monitors and cables, and will cause serious safety hazards as the electrical insulating properties and structural integrity of the equipment break down. • These germicidal products are safe for use ONLY on hard, non-porous surfaces, such as linoleum floors, formica countertops, and stainless steel. Cleaning the DisplayClean the display with a soft cloth moistened with either 70% isopropyl alcohol solution or soapy water.Notes:Obey your hospital protocol for the handling of blood and body fluids.Transmitter, Leadwires, Cables, and SensorsCleaning/DisinfectingWarnings:• Use only recommended cleaning solutions, or you may void the manufacturer’s warranty.• Harsh chemical agents degrade plastics and compromise the safety of the device. Some germicidal and other harsh cleaning compounds are known to damage some plastics by weakening the structural integrity and compromising the electrical insulating properties. • Disconnect the equipment from the patient before cleaning.D R A F T 22 June 2012
CLEANING, DISINFECTING, AND STERILIZATIONTELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 5-2• Do not immerse the equipment or cables in water or cleaning solutions.• Do not autoclave.Recommended Cleaning SolutionsUse only the recommended cleaning solutions that follow:• Mild soap and water solution• U.S. Pharmacopoeia (USP) green soap• Sodium hypochlorite solution (1:10 dilution of household chlorine bleach in water)• Phenolic germicidal detergent (1% aqueous solution)• Isopropyl alcohol (70% solution)Caution:Questions and concerns about cleaning issues should be directed to Spacelabs Healthcare Technical Support.Note:• Repeated use of a chlorine bleach solution may cause some colors to fade.• Tape adhesive can be removed with Spacelabs Healthcare adhesive tape remover pads (P/N 392196-001).Accessories• Where provided, obey the manufacturers' instructions concerning disposable and reusable supplies.• As applicable, obey your hospital protocol concerning cleaning, disinfection, and/or sterilization of reusable supplies.• Obey hospital protocols to dispose of used and contaminated single-use accessories.Cleaning and Disinfecting the 96281Telemetry Transmitters and CablesIn normal use the product is worn by one hospital patient for a few days. Clean and disinfect the transmitter after every procedure and/or before it is worn by another patient. There is a risk that the product may carry dangerous levels of infectious agents to the next patient if it is not adequately cleaned and/or disinfected.Refer to Recommended Cleaning Solutions on page 5-2 for a list of acceptable cleaning solutions.D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL 5-3CLEANING, DISINFECTING, AND STERILIZATIONBasic Cleaning and Low-level Disinfection1Remove the batteries and close the battery cover.2Remove the ECG leadwires, grouper, and SPO2 cable (if fitted).3Inspect the transmitter for contamination. If required and carry out steps 4 and 5 to clean the transmitter.4Rub the transmitter with a cloth wetted in a mild detergent solution.5Dry the transmitter thoroughly.6Prepare the cleaning solution chosen from the list of recommended cleaning solutions according to the manufacturer’s instructions.7Wet a clean cloth with the selected cleaning solution.8Remove excess liquid from the cloth and squeeze dry.9Wipe all exposed surfaces of the equipment and cables.10 Leave the transmitter for the required contact time, during which it should remain wet.11 Remove any soap residue by gently wiping with a clean damp cloth.12 Wipe dry with a clean dry cloth.13 Take steps to remove disinfectant residues in accordance with the disinfectant labelling.Cleaning ECG LeadwiresInspect the leadwire sockets for contamination. If necessary, flush using a syringe and clean using a toothpick. Once clean, Spacelabs Healthcare recommends wetting the sockets with 70% isopropyl alcohol to provide low level disinfection. This agent can be left to dry naturally and does not require any rinse procedures.Note: After cleaning ECG leadwires, remove the ECG leadwires from the lead block and thoroughly dry them at the lead block ends and at the lead connector ends. Thorough drying will prevent residual moisture from providing a low-current path between leads, which can interfere with lead off detection and cause false asystoles.Cleaning ButtonsClean the buttons by wetting a small brush with a mild detergent solution and gently scrubbing around and across the buttons. Dry the buttons with a rubbing action.Disinfect the buttons by using the same method. Spacelabs Healthcare recommends using 70% isopropyl alcohol which can be left to dry naturally and does not require any rinse procedures.Cleaning the Battery CoverClean around the battery cover release with a small brush using a mild detergent solution. Disinfect using the same method with 70% isopropyl alcohol to provide low level disinfection. Open the battery cover and inspect the hinges and catch for contamination. If necessary, flush using a syringe and clean using a small brush, taking care not to deform the cover spring. Once clean, we recommend wetting with 70% isopropyl alcohol to provide low level disinfection. This agent can be left to dry naturally and does not require any rinse procedures.D R A F T 22 June 2012
D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL A-1Appendix A — Guidance and Manufacturer’s DeclarationElectromagnetic EnvironmentThe 96281 telemetry transmitter is intended for use in the electromagnetic environment specified in the reference tables in this chapter. The customer or user of the 96281 should make sure that it is used in such an environment.Electromagnetic EmmissionsTable 1—Electromagnetic EmmissionsEmission Test Compliance Electromagnetic EnvironmentRF emissions CISPR 11 Group 1 The 96281 emits electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.RF emissions CISPR 11 Class BThe 96281 is suitable for use in all establishments, including those directly connected to the public low-voltage power supply network that supplies public buildings. Harmonic emissions IEC 61000-3-2 N/A N/AVoltage fluctuations/flicker emissions IEC 61000-3-3N/A N/AD R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL A-2APPENDIX A — GUIDANCE AND MANUFACTURER’S DECLARATIONElectromagnetic ImmunityTable 2—Electromagnetic ImmunityImmunity Test IEC 60601 Test Level Compliance LevelElectromagnetic EnvironmentElectrostatic discharge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burstIEC 61000-4-4±2 kV for power supply lines±1 kV for input/output lines N/A N/ASurgeIEC 61000-4-5±1 kV line(s) to line(s)±2 kV line(s) to earth N/A N/AVoltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11<5% UT(>95% dip in UT for 0.5 cycle)40% UT(60% dip in UT for 5 cycles)70% UT(30% dip in UT for 25 cycles)<5% UT(>95% dip in UT for 5 seconds)N/A N/APower frequency(50/60 Hz)magnetic fieldIEC 61000-4-83A/m 3A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a commercial or hospital environment.Note: UT is the AC mains voltage prior to application of the test level. D R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL A-3APPENDIX A — GUIDANCE AND MANUFACTURER’S DECLARATIONTable 2—Electromagnetic Immunity (continued)Immunity TestIEC 60601 Test LevelCompliance Level Electromagnetic EnvironmentConducted RFIEC 61000-4-6 N/A N/A Portable and mobile RF communications equipment should be used no closer to any part of the monitoring device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance: Where P is the maximum output power rating of the transmitter in watts (W), according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range.Interference may occur in the vicinity of equipment marked with the following symbol.Radiated RFIEC 61000-4-33V/m80 MHz to 2.5 GHz3V/m(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the monitoring device are used exceeds the applicable RF compliance level above, the 96281 telemetry device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 96281 telemetry device.Notes:• At 800 MHz, the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.d = 1.17 P80 MHz to 800 MHzd = 2.34 P800 MHz to 2.5 GHzD R A F T 22 June 2012
TELEMETRY TRANSMITTER (96281) OPERATIONS MANUAL A-4APPENDIX A — GUIDANCE AND MANUFACTURER’S DECLARATIONSeparation DistancesThe 96281 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the 96281 telemetry transmitter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 96281 as recommended below, according to the maximum output power of the communications equipment.Table 3—Separation DistancesRecommended separation distances between portable and mobile RF communications and the 96281 telemetry transmitterRated maximum output power of Transmitter (W)Separation distance according to the frequency of transmitter (m)0.01 0.117 0.2340.1 0.37 0.7381 1.17 2.3410 3.69 7.37100 11.7 23.4For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Notes:• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.d = 1.17 P80 MHz to 800 MHzd = 2.34 P800 MHz to 2.5 GHzD R A F T 22 June 2012
Telemetry Transmitter (96281) Operations Manual B-1Appendix B — SymbolsThe following list of international and safety symbols describes all symbols used on Spacelabs Healthcare products. No one product contains every symbol.Note: Graphic elements of certain keys and symbols may vary between product lines.HELP KeyHELP (Explain Prior Screen) KeyMONITOR SETUP KeyREMOTE KeyTRENDS KeyRECORD KeyDynamic Network Access (DNA) KeySPECIAL FUNCTIONS KeyNORMAL SCREEN KeySAVE Key?D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-2No Network ConnectionNetwork ConnectionDo Not Connect to NetworkNo Connection to Intesys® Clinical Suite (ICS)CompressionMagnifying GlassFile CabinetList of RoomsPrinterService MessagePREVIOUS MENU KeyHOME KeyArrowsOn DirectionON — Power Connection to MainsD R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-3ON — Part of the Instrument OnlyON Position for Push Button Power SwitchOFF — Power Disconnection from MainsOFF Position for Push Button Power SwitchOFF — Part of the Instrument OnlyPartial ON/OFFON/OFFStandbySTANDBY KeyPower ON/OFF KeyKeyboard ConnectionMouse ConnectionPAUSE or INTERRUPTSTART/STOP KeySTART/STOPSTOP or CANCEL KeyCONTINUE KeyENTER KeyD R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-4DeleteNurse Alert InterfaceALARM SUSPEND/TONE RESET KeyALARMS KeyAlarm, GeneralAlarm ResetAlarm Audio ONAlarm Audio OFFAlarm Audio PausedLow Priority AlarmMedium Priority AlarmHigh Priority AlarmAlarms PausedAlarm OFFParameter below measurement rangeParameter above measurement rangex---+++D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-5Parameter measurement indeterminateIndicator — Remote ControlPRINT REPORT KeyNormal ScreenClock/Time Setting KeySlow RunActivate Recorder for GraphicsResetSTART (NIBP) KeyPower Indicator LEDActivate Telemetry RecorderOutput (Non-terminated)Data Input/OutputInputNo Output (Terminated)Indicator — Local Control???D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-6Indicator — Out of PaperRecorder PaperMenu KeysWaveform/Parameter KeysReturn to Prior MenuMonitor SetupSelect Program OptionsSet Initial Conditions MenuAccess Special Function MenuReturn Unit to Monitor ModeKeypadSerial Port 1Serial Port 2Serial PortAuto Mode (NIBP)External Marker Push Button Connection123123123123A123B12312D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-7Arterial PulseGas ExhaustVideo OutputTelevision; Video DisplayVideo Output, PrimaryVideo Output, SecondaryEnlarge, ZoomInput/OutputPCMCIA CardTouchscreen, ExternalUniversal Serial BusSDLC PortHard DriveAntennaElectrocardiograph or Defibrillator SynchronizationSDLCD R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-8MicrophoneFoot SwitchAudio Output, SpeakerEventGas Sampling PortGas Return PortBatteryReplace only with the appropriate battery.Battery StatusBatteryReplace only with the appropriate battery.Low BatteryReplace only with the appropriate battery.(+ / - signs may be reversed)All batteries should be disposed of properly to protect the environment. Lithium batteries should be fully discharged before disposal. Batteries such as lead-acid (Pb) and nickel-cadmium (Ni-Cd) must be recycled. Please follow your internal procedures and or local (provincial) laws regarding disposal or recycling.This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.Caution - hazardous voltages. To reduce risk of electric shock, do not remove the cover or back. Refer servicing to a qualified field service engineer (U.S.A.).DANGER - High Voltage (International)Protective Earth GroundD R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-9Replace Fuse Only as MarkedPower supply jack polarity. (+ / - signs may be reversed)Alternating CurrentBoth Direct and Alternating CurrentFunctional Earth GroundFuseEquipotentiality TerminalDirect CurrentInput Power. Use only Spacelabs Power Supply (P/N 119-0527-xx).AC/DC InputLoop FilterAudio Output, SpeakerIEC 60601-1 Type B equipment. The unit displaying this symbol contains an adequate degree of protection against electric shock. IEC 60601-1 Type BF equipment which is defibrillator-proof. The unit displaying this symbol is an F-type isolated (floating) patient-applied part which contains an adequate degree of protection against electric shock, and is defibrillator-proof. IEC 60601-1 Type BF equipment. The unit displaying this symbol is an F-type isolated (floating) patient-applied part providing an adequate degree of protection against electric shock.D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-10IEC 60601-1 Type CF equipment. The unit displaying this symbol is an F-type isolated (floating) patient-applied part providing a high degree of protection against electric shock, and is defibrillator-proof.IEC 60601-1 Type CF equipment. The unit displaying this symbol is an F-type isolated (floating) patient-applied part providing a high degree of protection against electric shock.IEC 60601-1 Class II equipment, double-isolated. The unit displaying this symbol does not require a grounded outlet.Warning: Do not modify this equipment without authorization of the manufacturer.Operates on Non-Harmonized Radio Frequencies in EuropeAdult Noninvasive Blood Pressure (NIBP)Fetal Monitor Connection (Analog)Fetal Monitor ConnectionRS-232 (Digital)Physiological Monitor Connection RS-232 (Digital)Noninvasive Blood Pressure (NIBP), Symbol Set, Adult/Pediatric Cuff SizesSymbol Set, Neonatal Cuff SizesNIBP Cuff, Neonatal 1NIBP Cuff, Neonatal 2NIBP Cuff, Neonatal 3!D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-11NIBP Cuff, Neonatal 4NIBP Cuff, Neonatal 5NIBP Cuff, Single HoseNIBP Cuff, Dual HoseNIBP Cuff, Surface Applied to PatientNIBP Cuff, Child Size (12 to 19 cm)NIBP Cuff, Child Size, Long (12 to 19 cm)NIBP Cuff, Small Adult Size, Long (17 to 25 cm)NIBP Cuff, Small Adult Size (17 to 25 cm)NIBP Cuff, Adult Size, Long (23 to 33 cm)NIBP Cuff, Large Adult Size, Long (31 to 40 cm)NIBP Cuff, Large Adult Size (31 to 40 cm)NIBP Cuff, Adult Size (23 to 33 cm)NIBP Cuff, Infant Size (8 to 13 cm)NIBP Cuff, Neonatal 1 Size (3 to 6 cm)THIS SIDE TO PATIENTCHILDCHILD, LONGSMALL ADULT, LONGSMALL ADULTADULT, LONGLARGE ADULT, LONGLARGE ADULTADULTINFANTNEONATAL 1D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-12NIBP Cuff, Neonatal 2 Size (4 to 8 cm)NIBP Cuff, Neonatal 3 Size (6 to 11 cm)NIBP Cuff, Neonatal 4 Size(7 to 13 cm)NIBP Cuff, Neonatal 5 Size(8 to 15 cm)NIBP Cuff, Thigh Size (38-50 cm)NIBP Cuff, Nylon MaterialNIBP Cuff, Soft MaterialNIBP Cuff, Vinyl MaterialQuantityPlace Artery Symbol and Arrow over Brachial or Femoral ArteryFollow Instructions For UseWarningWarning About Potential Danger to Human Beings (Consult Accompanying Documents)Caution Caution About Potential Danger to a Device (Consult Accompanying Documents)Note NoteKeep DryNEONATAL 2NEONATAL 3NEONATAL 4NEONATAL 5THIGHNYLONSOFTVINYLQTYARTERY!D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-13Indoor Use OnlyEnvironmental Shipping/Storage Altitude LimitationsEnvironmental Shipping/Storage Temperature LimitationsFragile; Handle with CareThis Way UpUp ArrowDown ArrowEnvironmental Shipping/Storage Humidity LimitationsOpen PadlockClosed PadlockHappy FaceSad FacePVC-Free (Polyvinyl Chloride)Do Not Reuse; Single Use OnlyReusable12,200 mPVC2D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-14Drip-ProofIPX7 Unit can withstand accidental immersion in one meter of water for up to 30 minutesReference Number or Order NumberUse by date [YYYY-MM-DD]RecycleNon SterileLatex-FreeDate of ManufactureManufacturerRadio transmitting device; elevated levels of non-ionizing radiationA CE mark certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. XXXX is the European Notified Body number. 0123 is the number for TÜV SÜD Product Service GmbH, München, Germany.Canadian Standards Association ApprovedBatch CodeNellcor Oxisensor II CompatibleREFXXXX®C ULOTNE2D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-15Abbreviations used as symbols are shown below.Novametrix CompatibleSpacelabs TruLink CompatibleNellcor OxiMax CompatibleSpacelabs CompatibleUL recognized component in Canada and United StatesNellcor OxiMax CompatibleMasimo SET Compatible1 - 32 Access Codes 1 Through 32AIR AirAmperesANT 1ANT 2Diversity Antenna System 1Diversity Antenna System 2Arr1ArrNet2Arrhythmia Net 1Arrhythmia Net 2avDO2Arterial/Venous Oxygen DifferenceCaO2Arterial OxygenCHchEEG, EMG, or ECG ChannelEEG Channels - CH1, CH2, CH3, CH4EMG Channel - CH5cmH2OCentimeters of WaterC.O.CO Cardiac OutputCvO2Venous OxygenCO2CO2Carbon DioxideNVXRAD R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-16DIAdia DiastolicECGecg ElectrocardiogramEEGeeg ElectroencephalogramEMGemg ElectromyogramESIS Electrosurgical Interference SuppressionEXT ExternalFECG Fetal ElectrocardiogramFHR1FHR2Fetal Heart Rate, Channel 1Fetal Heart Rate, Channel 2GNDgnd GroundHertzHgb HemoglobinHLOhlo High-Level OutputMultiview Multi-Lead ElectrocardiogramN2ONitrous OxideNIBPnibp Noninvasive Blood PressureO2AV Oxygen AvailabilityO2OxygenPaO2Partial Pressure of Arterial OxygenPRESSpressPRSPressurePvO2Partial Pressure of Mixed Venous OxygenOxygen reference gas portRESPresp RespirationSDLC Synchronous Data Link ControlHz Ref.D R A F T 22 June 2012
Appendix B — SymbolsTelemetry Transmitter (96281) Operations Manual B-17SPO2SpO2SpO2SaO2Arterial Oxygen Saturation as Measured by Pulse OximetrySVO2SvO2SvO2Mixed Venous Oxygen SaturationSYSsys SystolicT1T2T3T4Temperature 1Temperature 2Temperature 3Temperature 4TEMPtemp TemperatureUA Uterine Activity or Umbilical ArteryUV Umbilical VenousVAC Vacuum ConnectionVO2Oxygen ConsumptionVoltsWattsVWD R A F T 22 June 2012

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