GE Medical Systems Information Technologies 340MT WMTS Transmitter User Manual

GE Medical Systems Information Technologies Inc. WMTS Transmitter

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Ex 13a pages 1 to 40

Corometrics Model 340OPERATOR’S MANUAL MANUAL P/N 2006899-001 REV. AIUPTOCO+~XXX340 Telemetry ReceiverREFER TO MANUAL FOR PROPER TRANSDUCERSULTRASOUND ECG UAXXX340 Telemetry Transmitter

Corometrics Model 340OPERATOR’S MANUAL MANUAL P/N 2006899-001 REV. AIUPTOCO+~XXX340 Telemetry ReceiverREFER TO MANUAL FOR PROPER TRANSDUCERSULTRASOUND ECG UAXXX340 Telemetry Transmitter

Revision A Model 340 Telemetry System i2006899-001ContentsFigures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vTables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiPreface Overview of Telemetry Systems. . . . . . . . . . . . . . . . . . . . . .ixAbout Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xModel 340 Original Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xModel 340 Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xModel 340M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xIdentifying Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiIdentifying Model 340 Original Release and Model 340 Plus Telemetry Systems . . xiIdentifying a Model 340M Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii1Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2General Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2Definitions of Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Equipment Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8FCC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9FCC Rules Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9FCC RF Exposure Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9FCC Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9Wireless Medical Telemetry Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

ii Model 340 Telemetry System Revision A2006899-0012Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Product Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Product Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33Controls, Indicators, and Connectors . . . . . . . . . . . . . . . 3-1Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Receiver Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2Receiver Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Transmitter Bottom Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Transmitter Top Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8Transmitter Rear Panel Battery Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . 3-104Setup Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Connecting the Receiver and Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Models 115, 116, 118, 145, 150, 151, and 155 . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2120 and 170 Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5Setting Up the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7Installing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7Attaching the Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Attaching the Carrying Strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9Performing a Functional Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10Initial Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10Testing the Radio Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10Testing the Ultrasound Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11Testing the ECG Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13Testing the UA Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14Testing the Remote Event Marker Function . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16Testing the Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

Revision A Model 340 Telemetry System iii2006899-0015Monitoring via Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Suggestions for Ambulatory Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2Monitoring Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3FECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3Tocotransducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4IUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-46Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1General Cleaning Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Cleaning the Transmitter and Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1Problem Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . 8-1General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4FECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Tocotransducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6IUPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7MECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-89Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 9-1Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

iv Model 340 Telemetry System Revision A2006899-001For your notes

Revision A Model 340 Telemetry System v2006899-001FiguresFigure Preface-1.Model 340 or Model 340 Plus REF Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xiFigure Preface-2.Model 340M REF Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiiFigure 5-1.Receiver Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2Figure 5-2.Receiver Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4Figure 5-3.Transmitter Bottom Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Figure 5-4.Transmitter Top Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8Figure 5-5.Transmitter Rear Panel Battery Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10Figure 6-1.Positioning the Receiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Figure 6-2.Attaching the Receiver Antenna. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3Figure 6-3.Attaching the Receiver Interconnect Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3Figure 6-4.Attaching the Monitor Interconnect Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4Figure 6-5.Attaching the Remote Mark Interconnect Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4Figure 6-6.Attaching the Receiver Antenna. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5Figure 6-7.Attaching the Monitor Interconnect Cable to a 120 Series Monitor . . . . . . . . . . . . . . .4-6Figure 6-8.Attaching the Monitor Interconnect Cable to a 170 Series Monitor . . . . . . . . . . . . . . .4-6Figure 6-9.Accessing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

vi Model 340 Telemetry System Revision A2006899-001Figure 6-10.Transmitter Battery Orientation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8Figure 6-11.Attaching the Transmitter Antenna. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9Figure 6-12.Attaching the Carrying Strap. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9Figure 6-13.Applying Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10Figure 6-14.Connecting an Ultrasound Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11Figure 6-15.Connecting the Headset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12Figure 6-16.Connecting an FECG Cable/Legplate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13Figure 6-17.Connecting a Tocotransducer or IUPC Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14

Revision A Model 340 Telemetry System vii2006899-001TablesTable 3-1.Definitions of Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3Table 3-2.Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8Table 3-3.FCC Rules Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9Table 4-1.Summary of Monitor Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3Table 5-1.Receiver Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3Table 5-2.Receiver Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5Table 5-3.Transmitter Bottom Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7Table 5-4.Transmitter Top Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9Table 9-1.Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2Table 10-1.General Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2Table 10-2.Paper Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3Table 10-3.Ultrasound Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4Table 10-4.FECG Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5Table 10-5.Tocotransducer Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6Table 10-6.IUPC Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7Table 10-7.MECG Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

viii Model 340 Telemetry System Revision A2006899-001For your notes

Revision A Model 340 Telemetry System ix2006899-001PrefaceOverview of Telemetry Systems PrefaceThis chapter provides an overview of the 340 Series of telemetry systems:About Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xIdentifying Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

x Model 340 Telemetry System Revision A2006899-001Overview of Telemetry Systems: About Your SystemAbout Your SystemDue to continuing product innovations, there are three versions of the Model 340 Telemetry System in hospitals today. All three versions operate identically from a user’s perspective. Unless otherwise indicated, the information in this manual applies to all three devices.Model 340 Original ReleaseThe first release of the Model 340 Telemetry System operates in the frequency range 430–470 MHz.Model 340 PlusThe Model 340 Plus also operates in the frequency range 430–470 MHz offering additional channel numbers than the original Model 340. In addition, the Model 340 Plus offers flexibility by allowing factory re-programming to an alternative channel number should interference become a factor in your location.Model 340MThe Model 340M operates in the frequency range 608–614 MHz where the “M” indicates “medical”. The Model 340M complies with the Federal Communications Commission (FCC) rules for Wireless Medical Telemetry Service (WMTS). In June 2000, the FCC allocated a new spectrum allowing potentially life-critical equipment to operate on an interference-protected basis. Refer to “Wireless Medical Telemetry Service” on page 1-10 in this manual for additional information.

Revision A Model 340 Telemetry System xi2006899-001Overview of Telemetry Systems: Identifying Your SystemIdentifying Your SystemEach GE Medical Systems Information Technologies device has a unique serial number tag for identification. For each Model 340 Telemetry System, a reference number can be used to determine if the unit is a Model 340 Original Release, Model 340 Plus, or Model 340M. If your device’s REF number begins with “0”, refer to “Identifying Model 340 Original Release and Model 340 Plus Telemetry Systems” next on this page. If your device’s REF number begins with “3”, refer to “Identifying a Model 340M Telemetry System” on the following page.Identifying Model 340 Original Release and Model 340 Plus Telemetry SystemsIf your device’s REF number beings with “0”:the fourth character identifies receiver or transmitterthe fifth character identifies Model 340 Original Release or Model 340 PlusRefer to Figure 1.Figure Preface-1. Model 340 or Model 340 Plus REF NumberExample 1: If a serial number label shows REF 0341AAN-501, it is a receiver from a Model 340 Original Release system.Example 2: If a serial number label shows REF 0342BBN-XXX00B, it is a transmitter from a Model 340 Plus system.0 3 4 _ _ _ _ - _ _ _ _ _ _Product Code Catalog Number Other Device Characteristics1 = Telemetry Receiver2 = Telemetry TransmitterVersionA = Model 340 Original ReleaseB = Model 340 PlusLanguage/VoltageSpecifiers Three to six characters thatfurther describe the unit.

xii Model 340 Telemetry System Revision A2006899-001Identifying a Model 340M Telemetry SystemIf your device’s REF number beings with “3”:the third character identifies receiver or transmitterthe fourth character identifies Model 340MRefer to Figure 2.Figure Preface-2. Model 340M REF NumberExample 1: If a serial number label shows REF 341MCCN-XXX00A, it is a receiver from a Model 340M telemetry system.Example 2: If a serial number label shows REF 342MBBN-XXX000B, it is a transmitter from a Model 340M telemetry system.3 4 _ M _ _ _ - _ _ _ _ _ _Product Code Catalog Number Other Device Characteristics1 = Telemetry Receiver2 = Telemetry TransmitterOption/Language/VoltageSpecifiers Three to six characters thatfurther describe the unit.M = Model 340 Medical

Revision A Model 340 Telemetry System 1-12006899-001Chapter 1Safety 1The information presented in this section is important for the safety of both the patient and operator and also serves to enhance equipment reliability. This chapter describes how the terms Danger, Warning, Caution, Important, and Note are used throughout the manual. In addition, standard equipment symbols are defined. This section includes the following important information:General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Definitions of Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Equipment Safety Information . . . . . . . . . . . . . . . . . . . . . . . 1-4Equipment Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8FCC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9!

1-2 Model 340 Telemetry System Revision A2006899-001Safety: General InformationGeneral InformationGeneral UseIf any equipment is cold to the touch or below ambient temperature, allow it to stabilize before use.To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Parts and accessories used shall meet the requirements of IEC 601.1.1.Disposable devices are intended for single use only. They should not be reused.Periodically, and whenever the integrity of the equipment is in doubt, test all functions.Refer to the "Maternal/Fetal Monitoring Operator’s Manual" for information concerning the limitations of internal and external fetal heart rate monitoring techniques.Responsibility of the ManufacturerGE Medical Systems Information Technologies (hereinafter Information Technologies) is responsible for the effects on safety, reliability, and performance if:assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by Information Technologies;the electrical installation of the relevant room complies with the requirements of appropriate regulations; andthe equipment is used in accordance with the instructions for use.

Revision A Model 340 Telemetry System 1-32006899-001Safety: Definitions of TerminologyDefinitions of TerminologySix types of special notices are used throughout this manual. They are: Danger, Warning, Caution, Contraindication, Important, and Note. The warnings and cautions in this safety section relate to the equipment in general and apply to all aspects of the equipment. Be sure to read the other chapters because there are additional warnings and cautions which relate to specific features of the equipment.When grouped, warnings and cautions are listed alphabetically and do not imply any order of importance.Table 1-1. Definitions of TerminologyDanger A DANGER notice indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.Warning A WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.CautionA CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Cautions are also used to avoid damage to equipment.ContraindicationA CONTRAINDICATION describes any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of a risk.Important An IMPORTANT notice indicates an emphasized note. It is something you should be particularly aware of; something not readily apparent.Note A NOTE indicates a particular point of information; something on which to focus your attention.

1-4 Model 340 Telemetry System Revision A2006899-001Safety: Equipment Safety InformationEquipment Safety InformationWarnings:$51,1*6ACCIDENTAL SPILLS—In the event that fluids are accidentally spilled on the equipment, take the equipment out of operation and inspect for damage.APPLICATION—This equipment is not designed for direct cardiac connection.CONDUCTIVE CONNECTIONS—Avoid making any conductive connections to applied parts (patient connection) which are likely to degrade safety.CONDUCTIVE PARTS—Ensure that the conductive parts of the lead electrodes and associated connectors do not contact other conductive parts including earth.CONNECTIONS—The correct way to connect a patient to the transmitter is to plug the electrode leads into the patient cable which in turn connects to the transmitter. The receiver is connected to the wall socket by the power cord. Do not plug the electrode leads into the power cord, a wall socket, or an extension cord.DEFIBRILLATION—This equipment is not designed for use with defibrillators.ELECTRICAL SHOCK—To reduce the risk of electrical shock, do not remove equipment covers. Refer servicing to qualified personnel.ELECTROMAGNETIC INTERFERENCE—Be aware that strong electromagnetic fields may interfere with equipment operation. Interference prevents the clear reception of signals by the device. If the hospital is close to a strong transmitter such as TV, AM or FM radio, police or fire stations, a HAM radio operator, an airport, or cellular phone, their signals could be picked up as signals by the equipment. If you feel interference is affecting the equipment, contact your Service Representative to check the equipment in your environment.

Revision A Model 340 Telemetry System 1-52006899-001Safety: Equipment Safety Information:$51,1*6ELECTROSURGERY—The equipment is not designed for use with high-frequency surgical devices. In addition, measurements may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment.EXPLOSION HAZARD—Do not use this equipment in the presence of flammable anesthetics or inside an oxygen tent.GROUNDING—Do not defeat the three-wire grounding feature of the power cord by means of adaptors, plug modifications, or other methods. A dangerous shock hazard to both patient and operator may result.INSTRUCTIONS—For continued and safe use of this equipment, it is necessary to follow all listed instructions. However, the instructions provided in this manual in no way supersede established medical procedures concerning patient care. The device does not replace observation and evaluation of the patient, at regular intervals, by a qualified care provider who will make diagnoses and decide on treatments and interventions.INTERFACING OTHER EQUIPMENT—Monitoring equipment must be interfaced with other types of medical equipment by qualified biomedical engineering personnel. Be certain to consult manufacturers’ specifications to maintain safe operation.LEAKAGE CURRENT TEST—The interconnection of auxiliary equipment with this device may increase the total leakage current. When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. Serious injury or death could result if the leakage current exceeds applicable standards. The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: use of the accessory in the patient vicinity; and evidence that the safety certification of the accessory has been performed in accordance with the appropriate IEC 601.1 and/or IEC 601.1.1 harmonized national standard.

1-6 Model 340 Telemetry System Revision A2006899-001Safety: Equipment Safety Information:$51,1*6LINE ISOLATION MONITOR TRANSIENTS—Line isolation monitor transients may resemble actual cardiac waveforms, and thus cause incorrect heart rate determinations and alarm activation (or inhibition).MRI USE—Do not use the equipment during MRI scanning; conducted current could potentially cause burns.PATIENT CABLES AND LEADWIRES—Do not use patient cables and electrode leads that permit direct connection to electrical sources. Use only “safety” cables and leadwires. Use of non-safety patient cables and lead wires creates risk of inappropriate electrical connection which may cause patient shock or death.PACEMAKER PATIENTS—Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. Refer to your monitor’s operator’s manual for disclosure of the pacemaker pulse rejection capability.SIMULTANEOUS DEVICES—Do not simultaneously connect more than one device that uses electrodes to detect ECG and/or respiration to the same patient. Use of more than one device in this manner may cause improper operation of one or more of the devices.STRANGULATION—Make sure all patient cables, leadwires, and tubing are positioned away from the patient’s head to minimize the risk of accidental strangulation.WATER BIRTHS—Do not use a fetal or maternal/fetal monitor to directly monitor patients during water births, in whirlpool or submersion water baths, during showers, or in any other situation where the mother is immersed in water. Doing so may result in electrical shock hazard.

Revision A Model 340 Telemetry System 1-72006899-001Safety: Equipment Safety InformationCautions&$87,216ANNUAL SERVICING—For continued safety and performance of the equipment, it is recommended that the calibration, accuracy, and electrical safety of the equipment be verified on an annual basis by an Information Technologies Service Representative.DAILY INSPECTION—It is essential that the equipment and accessories be inspected prior to every use.ENVIRONMENT—The performance of the equipment has not been tested in certain areas, such as x-ray and imaging suites. The equipment is not recommended for use in these environments.PERFORMANCE—Report all problems experienced with the equipment. If the equipment is not working properly, contact your Service Representative for service. The equipment should not be used if it is not working properly.

1-8 Model 340 Telemetry System Revision A2006899-001Safety: Equipment SymbolsEquipment SymbolsThe following is a list of symbols used on products manufactured by Information Technologies. Some symbols may not appear on your equipment.Table 1-2. Equipment SymbolsATTENTION: Consult accompanying documents.TYPE B EQUIPMENT. Type B equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application.TYPE BF EQUIPMENT. Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment has an F-type applied part.DEFIBRILLATOR-PROOF TYPE BF EQUIPMENT: Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment is type B equipment with an F-type isolated (floating) part. The paddles indicate the equipment is defibrillator proof.ALTERNATING CURRENT (AC).IPX1 DRIP PROOF.EQUIPOTENTIALITY.OPOWER OFF: disconnection from the mains.IPOWER ON: connection to the mains.!

Revision A Model 340 Telemetry System 1-92006899-001Safety: FCC InformationFCC InformationFCC Rules ComplianceThis equipment complies with the FCC rules shown in Table 1-3. (Refer to “Identifying Your System” on page xi for information about identifying what type of telemetry system you have in your hospital.) Operation is subject to the condition that this device does not cause harmful interference.FCC RF Exposure Compliance,03257$17RF EXPOSURE—To comply with FCC RF exposure compliance requirements, users should avoid grasping the antenna for any extended period of time while the device is in operation.FCC Service InformationServicing the radio frequency transmitter and receiver sections of the Model 340 Telemetry System requires an FCC General Radio Telephone License.Any changes or modifications made to the Model 340 Telemetry System that are not expressly approved by Information Technologies, could void the user’s authority to operate this equipment.Table 1-3. FCC Rules ComplianceTelemetry Transmitter ReceiverModel 340 Original Release Part 90 Part 15Model 340 Plus Part 90 Part 15Model 340M Part 95 Part 15

1-10 Model 340 Telemetry System Revision A2006899-001Safety: FCC InformationWireless Medical Telemetry ServiceThis section applies to Model 340M Telemetry Systems only. Refer to “Identifying Your System” on page xi for information about identifying what type of telemetry system you have in your hospital.,03257$17Operation of a Model 340M Telemetry System requires prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service.In June 2000, the FCC allocated new spectrum and established rules for Wireless Medical Telemetry Service (WMTS) allowing potentially life-critical equipment to operate on an interference-protected basis.The frequency allocation for WMTS provides spectrum where the equipment can operate on a primary basis increasing the reliability of this important service. The FCC allocated 14 MHz of spectrum for use by medical telemetry equipment in the 608–614 MHz, 1395–1400 MHz, and 1429–1432 MHz bands. This allocation was based on a needs assessment conducted by the American Hospital Association (AHA).The 608–614 MHz band, which corresponds to TV channel 37 had been reserved for radio astronomy uses, so this action elevates medical telemetry to a co-primary status with radio astronomy in this band. The 1395–1400 MHz and 1429–1432 MHz bands were government bands reallocated for non-government use.WMTS is designated as one of the Citizen’s Band Services in Part 95 of the rules and licensed by rule to eliminate the possible costs and delays to obtain individual operator’s licenses. The medical telemetry equipment is authorized under the certification procedure in Part 2 of the rules. One or more frequency coordinators maintain a database of all equipment used in conjunction with WMTS.For more information visit http://www.fcc.gov.

Revision A Model 340 Telemetry System 2-12006899-001Chapter 2Introduction 2This chapter contains the following information:Product Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Product Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2-4 Model 340 Telemetry System Revision A2006899-001For your notes

Revision A Model 340 Telemetry System 3-12006899-001Chapter 3Controls, Indicators, and Connectors 3This section describes all controls, indicators, and connectors on a Model 340 Telemetry System.Receiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

3-2 Model 340 Telemetry System Revision A2006899-001Controls, Indicators, and Connectors: ReceiverReceiverReceiver Front PanelFigure 3-1. Receiver Front PanelIUPTOCO+~XXX340 Telemetry ReceiverABCDE

Revision A Model 340 Telemetry System 3-32006899-001Controls, Indicators, and Connectors: ReceiverTable 3-1. Receiver Front PanelName DescriptionAUA Mode Selector SwitchThis switch communicates the active uterine activity mode to the fetal or maternal/fetal monitor:When monitoring with a tocotransducer, set the switch to the TOCO position.When monitoring with an intrauterine pressure catheter, set the switch to the IUP position.B Channel NumberThe channel number is the customer-designated receiving frequency of the receiver. For each telemetry system, the channel number of the receiver must be identical to the channel number of the transmitter. Also, if you have more than one telemetry system, or other RF devices, each system must have a unique channel number.CPower Switch and IndicatorThe Power switch turns the receiver on (I) and off (O). When set to on, the green Power indicator illuminates.D Low Battery IndicatorThe red Low Battery indicator flashes when you have approximately 10 minutes of transmitter battery power remaining. The Low Battery indicator stops flashing and lights continuously as soon as the battery is depleted.E Signal IndicatorThe green Signal indicator lights continuously when the receiver is accepting radio frequency signals from the transmitter. The Signal indicator flashes if the signal strength is weak or marginal.

3-4 Model 340 Telemetry System Revision A2006899-001Controls, Indicators, and Connectors: ReceiverReceiver Rear PanelNote: Antenna shown removed.Figure 3-2. Receiver Rear PanelANTENNAOUTPUTS TO MONITORCONNECT TOCOROMETRICSMONITORS ONLYULTRASOUND ECG UA!WARNING: TO REDUCE FIRE HAZARDREPLACE FUSE AS MARKED.CAUTION!120Vac~120V ~ 50-60HZ 30W0.25A SLOW BLOWAEDCB

Revision A Model 340 Telemetry System 3-52006899-001Controls, Indicators, and Connectors: ReceiverTable 3-2. Receiver Rear PanelName DescriptionAAC Line Connector and Fuseholder ModuleThis module houses the AC-line input connector and the main fuses for the receiver:100–120 VAC: requires two, 0.25 A slow-blow fuses.220–240 VAC: requires two, 0.2 A time-lag fuses.BAuxiliary Output ConnectorThis connector is used with 120 and 170 Series Monitors only. Do not use this connection method for Models 115, 116, 118, 145, 150, 151, and 155 Monitors.This connector outputs the US, ECG, UA, and Mark signals, acquired by telemetry, to a 120 or 170 Series Monitor. See page 4-5 for complete interconnection details.As soon as any telemetry mode is detected, the front panel of the 120 or 170 Series Monitor is disabled and all front panel inputs are ignored. In other words, telemetry and monitor modes cannot be “mixed and matched’; you must use telemetry only or direct monitoring only.For proper operation with a 170 Series Monitor, disconnect all transducers from the front panel of the monitor.CUS, ECG, UA, and Mark ConnectorsThese connectors are used with Models 115, 116, 118, 145, 150, 151, and 155 Monitors only. Do not use this connection method for 120 and 170 Series Monitors.Each connector outputs the respective signal, acquired by telemetry, to the fetal or maternal/fetal monitor:US: light grey connector which outputs the ultrasound signal.ECG: grey connector which outputs the FECG or MECG signal.UA: white connector which outputs the TOCO or IUPC signal.Mark: connector which outputs the Event Mark signal.See page 4-2 for complete interconnection details.D Antenna Connector Twist-on connector for attaching the receiver antenna.E Equipotential Lug Binding post terminal directly connected to the chassis for use as an equipotentiality connection.

3-6 Model 340 Telemetry System Revision A2006899-001Controls, Indicators, and Connectors: TransmitterTransmitterTransmitter Bottom PanelFigure 3-3. Transmitter Bottom PanelACB

3-8 Model 340 Telemetry System Revision A2006899-001Controls, Indicators, and Connectors: TransmitterTransmitter Top PanelNote: Antenna shown removed.Figure 3-4. Transmitter Top PanelABCDEA

3-10 Model 340 Telemetry System Revision A2006899-001Controls, Indicators, and Connectors: TransmitterTransmitter Rear Panel Battery CompartmentFigure 3-5. Transmitter Rear Panel Battery CompartmentThe battery compartment holds four “AA” alkaline batteries.&$87,21BATTERY STRENGTH—When the battery power is low, the transmitter emits a chirping sound every 4–5 seconds. (For Model 340 Plus and Model 340M Systems, the frequency of chirping increases as the batteries become depleted.) The onset of chirping signals approximately 10 minutes of remaining battery power. The chirping continues until the battery power is completely depleted, at which time the transmitter stops sending data. DANGER: POSSIBLE EXPLOSION HAZARD IF USEDIN THE PRESENCE OF FLAMMABLE ANESTHETICS.CAUTION: REFER SERVICE ONLY TO QUALIFIED PERSONNEL!BATTERY COMPARTMENTBattery Compartment

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