Bite Hole Indicator Users Manual Rev 03 Jan 2004

g

GE Medical Systems

30/01/04

 GE Medical Systems. All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of GE Medical Systems.

COMPANY DATA

GE VINGMED ULTRASOUND A/S

MANUAL STATUS KZ292800-03

Strandpromenaden 45, N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Table of Contents

Table of Contents Table of Contents Introduction Attention... 1

Chapter 1 Getting started Product overview... 4 Package content ... 4 Bite Hole Indicator overview ... 5 Preparing the device for use ... 6 Battery installation/replacement... 6 Connecting the leads to the device... 7

Chapter 2 Test procedure Prerequisites... 10 Test procedure... 10 Connection setup... 11

Appendix

Specifications ... 16 Electrical specifications... 16 Mechanical specifications ... 16 Operating environment ... 16 Functional test of Bite Hole Indicator ... 16 Safety... 17 Disposal... 17 Contact information ... 17

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Table of Contents

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Bite Hole Indicator User's Manual KZ292800-03

Introduction

Introduction This manual provides user information on the Bite Hole Indicator to be used with the GE TEE probes. To maintain patient safety it is important to check that the isolation of the endoscope is intact. The Bite Hole indicator is a device designed for detection of bite holes in the TEE probe endoscope.

Attention CAUTION

The test using the Bite Hole Indicator does not replace an isolation or leakage current test as described in EN 60601-1/IEC 60601-1. As a minimum, tests according these standards must be performed once a year.

Read and understand all instructions in the User’s Manual before attempting to use the Bite Hole Indicator. Keep the manual with the equipment at all time. Periodically review the procedure for operation and safety precautions.

Bite Hole Indicator User's Manual KZ292800-03

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Introduction

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Bite Hole Indicator User's Manual KZ292800-03

Getting started

Chapter 1 Getting started • Product overview ... ... 4 • Package content ... 4 • Bite Hole Indicator overview ... 5 • Preparing the device for use ... ... 6 • Battery installation/replacement ... 6 • Connecting the leads to the device ... 7

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Getting started

Product overview Package content The following is delivered with the Bite Hole Indicator device: • The User manual • The Bite Hole Indicator device • Three leads (two reds and one black) • A copper plate with cable

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Bite Hole Indicator User's Manual KZ292800-03

Getting started Bite Hole Indicator overview

1. Lead sockets to be connected to the probe.

4. Test button

2. Lead socket to be connected to the copper plate in saline solution.

5. Compartment lid for the battery (rear)

3. LEDs indicating test result, leads and connector proper connection and battery state.

Figure 1-1: The Bite Hole Indicator device

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Getting started

Preparing the device for use Battery installation/replacement The Bite Hole Indicator is using a 9V PP3 battery situated in a compartment on the rear of the device. 1. Unscrew the Philips screw and remove the battery compartment lid. 2. Remove the exhausted battery from the compartment and disconnect the clip-on connector. 3. Connect the new battery observing the polarity. 4. Insert the battery in the compartment. 5. Re-place the lid on the compartment, inserting first the hinges on the lower edge. Make sure not to pinch the battery wires. 6. Secure the lid in place with the screw. Do not overtighten. Make sure the screw gasket is in place.

Checking the battery 1.

6

With no leads connected, press . Depending on the battery state the LED display will show:

Leads

Fail

Pass

The battery is charged.

Leads

Fail

Pass

The battery is discharged.

Leads

Fail

Pass

No battery inserted or exhausted battery.

Bite Hole Indicator User's Manual KZ292800-03

Getting started Connecting the leads to the device Connect the leads to the device as shown below:

1. Red leads connected to yellow and red sockets. 2. Black lead connected to black socket.

Figure 1-2: Leads connection on the Bite Hole Indicator

Checking leads and connectors Inspect the test leads for apparent damages. Broken or damaged leads and corroded connectors must be replaced prior to use. Perform the three following tests to check leads and connectors: Setup Connect all three alligator clips together. Connect both red alligator clips together, disconnect the black lead. All three leads disconnected from each other.

Bite Hole Indicator User's Manual KZ292800-03

Action

Expected result

Press

.

Leads

Fail

Pass

Press

.

Leads

Fail

Pass

Press

.

Leads

Fail

Pass

7

Getting started If one or more tests does not give the expected result, the Bite Hole Indicator instrument is defective and needs repair or replacement. Do not use the device to test TEE probes. Contact your local representative.

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Bite Hole Indicator User's Manual KZ292800-03

Test procedure

Chapter 2 Test procedure • Prerequisites ... ... 10 • Test procedure ... ... 10 • Connection setup ... 11

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Test procedure

Prerequisites The following items are required in addition to the Bite Hole Indicator device: • A water bath big enough to immerse the endoscope above the 40 cm mark. • Normal saline solution (50 g NaCl / 1 liter water)

Test procedure 1. 2.

Immerse the probe endoscope in the saline solution to above the 40 cm mark and secure the probe. Connect the The Bite Hole Indicator to the probe as shown in ’Connection setup’ on page 11. The connection points on the probe are dependant of the probe type.

3.

Press

4.

Read the test result (see below).

.

Test result

10

Interpretation The leads are not connected correctly. Check the connections and test again.

Leads

Fail

Pass

Leads

Fail

Pass

Leads

Fail

Pass

No bite holes are found in the endoscope.

Leads

Fail

Pass

The battery is discharged. Replace the battery and test again.

There is a bite hole in the probe endoscope. Do not use the TEE probe and contact your local representative.

Bite Hole Indicator User's Manual KZ292800-03

Test procedure Connection setup The connection of the red leads to the probe depends on the TEE probe type. Follow the recommendation in the figures below to properly set up the connection.

CAUTION

The Bite Hole Indicator is not designed for measuring voltage input to the external connections. Connecting voltage or current sources of any kind to the lead connections may permanently damage the device. Avoid immersing the test leads in the saline solution.

CAUTION

Do not immerse the Bite Hole Indicator device.

Connection setup for the 6T/6Tv/9T probes

1. TEE probe with the endoscope immersed to above the 40 cm mark. 2. Red leads connected to the bare metal around the pins of the system connector (or to the test connector supplied with the probe). 3. Black lead connected to the copper plate immersed in the saline solution. 4. Water bath containing 1 Normal saline solution.

Figure 2-1: Connection setup for the 6T/6Tv/9T probes

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Test procedure Connection setup for the 5T/PAMTE probes

1. TEE probe with the endoscope immersed to above the 40 cm mark. 2. Red leads connected to the metal hook where the key ring is fastened. 3. Black lead connected to the copper plate immersed in the saline solution. 4. Water bath containing 1 Normal saline solution.

Figure 2-2: Connection setup for the 5T/PAMPTE probes

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Bite Hole Indicator User's Manual KZ292800-03

Test procedure Connection setup for the 8T/Ped. MPTE probes

1. TEE probe with the endoscope immersed to above the 40 cm mark. 2. Red leads connected to the metal brake mechanism and to the bare metal around the pins of the system connector. 3. Black lead connected to the copper plate immersed in the saline solution. 4. Water bath containing 1 Normal saline solution.

Figure 2-3: Connection setup for the 8T/Ped. MPTE probes

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Test procedure Connection setup for the MPTE/TE probes

1. TEE probe with the endoscope immersed to above the 40 cm mark. 2. Red leads connected to the metal knob on top of the control wheels (or to the test connector supplied with the probe). 3. Black lead connected to the copper plate immersed in the saline solution. 4. Water bath containing 1 Normal saline solution.

Figure 2-4: Connection setup for the MPTE/TE probes

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Appendix

Appendix • Specifications ... ... 16 • Electrical specifications ... 16 • Mechanical specifications ... 16 • Operating environment ... 16 • Functional test of Bite Hole Indicator ... 16 • Safety ... 17 • Disposal ... ... 17 • Contact information ... ... 17

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Appendix

Specifications Correct indication of bite holes in the TEE probe endoscope with at least 99.9% confidence.

Electrical specifications • •

Test voltage: 2.46 V nominal open circuit Short circuit maximum current: 220 µA

Power source • •

•

Battery type: PP3 size, Alkaline Manganese MN1604 or equivalent Battery voltage: 9 V nominal More than 7 V is required for operation of the unit. 2.0 V–6.9 V indicates low battery voltage. Current consumption: 35–53 mA depending on indication status.

Mechanical specifications • • • • •

Weight: 157 g including battery and leads. Dimensions: 120 x 65 x 22 mm (L x W x H) Material: ABS (UL 94HB), color: Off-white Measuring leads: 100 cm Hirchmann 2 mm system solid pin and spring loaded socket Alligator clips: rust and acid-proof, clamping range 4 mm

Operating environment • •

Temperature: 10–40 °C Humidity: 30–85% (non-condensing)

Functional test of Bite Hole Indicator It is recommended to test the Bite Hole Indicator as described below once a year. 1. Connect the red and yellow lead sockets (1) to one lead of a 240 kOhm 1% resistor and the black lead socket (2) to the other lead of the same resistor (see Figure 1-1, page 5). Press

16

, the device must show Pass.

Bite Hole Indicator User's Manual KZ292800-03