Fluke 5000C User Manual

medTester 5000C

Biomedical Tester

Operators Manual

PN 2243153 February 2006

Warranty and Product Support

Fluke Biomedical warrants this instrument against defects in materials and workmanship for one full year from the date of original purchase. During the warranty period, we will repair or, at our option, replace at no charge a product that proves to be defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty does not apply if the product has been damaged by accident or misuse or as the result of service or modification by other than Fluke Biomedical. IN NO EVENT SHALL FLUKE BIOMEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES.

Only serialized products and their accessory items (those products and items bearing a distinct serial number tag) are covered under this one–year warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY. Items such as cables and nonserialized modules are not covered under this warranty.

Recalibration of instruments is not covered under the warranty.

This warranty gives you specific legal rights, and you may also have other rights which vary from state to state, province to province, or country to country. This warranty is limited to repairing the instrument to Fluke Biomedical’s specifications.

Warranty Disclaimer

Should you elect to have your instrument serviced and/or calibrated by someone other than Fluke Biomedical, please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality Seal is removed or broken without proper factory authorization. We strongly recommend, therefore, that you send your instrument to Fluke Biomedical for factory service and calibration, especially during the original warranty period.

Notices

 Copyright 2006, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language without the written permission of Fluke Biomedical.

Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke Biomedical.

Unpacking and Inspection

Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches.

Technical Support

For application support or answers to technical questions, either email

techservices@flukebiomedical.com or call 1-800- 648-7952 or 1-425-446-6945.

Claims

Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing materials in their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical condition but does not operate within specifications, or if there are any other problems not caused by shipping damage, please contact Fluke Biomedical or your local sales representative.

Standard Terms and Conditions

Refunds and Credits

Please note that only serialized products and their accessory items (i.e., products and items bearing a distinct serial number tag) are eligible for partial refund and/or credit. Nonserialized parts and accessory items (e.g., cables, carrying cases, auxiliary modules, etc.) are not eligible for return or refund. Only products returned within 90 days from the date of original purchase are eligible for refund/credit. In order to receive a partial refund/credit of a product purchase price on a serialized product, the product must not have been damaged by the customer or by the carrier chosen by the customer to return the goods, and the product must be returned complete (meaning with all manuals, cables, accessories, etc.) and in “as new” and resalable condition. Products not returned within 90 days of purchase, or products which are not in “as new” and resalable condition, are not eligible for credit return and will be returned to the customer. The Return Procedure (see below) must be followed to assure prompt refund/credit.

Restocking Charges

Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 %. Products returned in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20 %. Additional charges for damage and/or missing parts and accessories will be applied to all returns.

Return Procedure

All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or handling.

Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for repackaging:

 Use a double–walled carton of sufficient strength for the weight being shipped.  Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material

around all projecting parts.

 Use at least four inches of tightly packed, industry-approved, shock-absorbent material

around the instrument.

Returns for partial refund/credit:

Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order Entry Group at 1-800-648-7952 or 1425-446-6945.

Repair and calibration:

To find the nearest service center, goto www.flukebiomedical.com/service or

In the U.S.A.: Cleveland Calibration Lab Tel: 1-800-850-4606 Email: globalcal@flukebiomedical.com

Everett Calibration Lab Tel: 1-888-99 FLUKE (1-888-993-5853) Email: service.status@fluke.com

In Europe, Middle East, and Africa: Eindhoven Calibration Lab Tel: +31-402-675300 Email: ServiceDesk@fluke.com

In Asia: Everett Calibration Lab Tel: +425-446-6945 Email: service.international@fluke.com

Certification

This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it was shipped from the factory. Calibration measurements are

traceable to the National Institute of Standards and Technology (NIST). Devices for which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures.

WARNING

Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.

Restrictions and Liabilities

Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.

Manufacturing Location

The medTester 5000C is manufactured in Everett, WA, U.S.A.

Biomedical Test System

Contents

Table of Contents

1: GENERAL INFORMATION

SAFETY CONSIDERATIONS .......................................................... 1-1

General.....................................................................................1-1

Safety Symbols ........................................................................1-1

Introduction ..................................................................................1-2

How to Use This Manual...............................................................1-3

If You’ve Used The medTester 5000C Before... ......................1-3

If You’re New to The medTester 5000C... ...............................1-3

Where to Find Help ..................................................................1-4

Features........................................................................................1-5

Electrical Safety Testing .........................................................1-5

Performance Testing ...............................................................1-5

Manual Measurements............................................................. 1-5

Automatic Measurements........................................................1-5

Computer Control..................................................................... 1-6

medCheck ................................................................................1-6

medTester 5000C Optional Modules ............................................1-7

Features......................................................................................1-11

Optional Accessories .................................................................1-11

medTester 5000C Instrument Specifications ............................ 1-12

Line Voltage and Measurements ...........................................1-12

Leakage Current ....................................................................1-12

Equipment Current................................................................. 1-13

Resistance .............................................................................1-13

Isolated Power ....................................................................... 1-13

Toolbox ..................................................................................1-14

Test Receptacle..................................................................... 1-14

Ground Fault Circuit Interrupter............................................ 1-15

Performance Waveforms........................................................1-15

General Specifications ...............................................................1-16

ECG Connections ................................................................... 1-16

Data Input and Output ...........................................................1-16

RS-232C Serial Interface Parameters....................................1-16

Real Time Clock.....................................................................1-16

Accessories ................................................................................ 1-17

medTester 5000C Module Upgrades .....................................1-19

2: INSTALLATION

Factory Default Settings ..............................................................2-1

Power-Up Sequence .....................................................................2-2

Initialization..................................................................................2-3

Date and Time Setup ................................................................... 2-3

Audio Transducer......................................................................... 2-4

Enabling Modules ......................................................................... 2-5

Confirming Module Installation ............................................... 2-7

3: INSTRUMENT FAMILIARITY

Know Your medTester 5000C ...................................................... 3-1

Top Panel Controls, Displays, and Connectors....................... 3-1

Rear Panel Controls, Displays, and Connectors ..................... 3-3

Power Up ................................................................................. 3-4

Navigating the Menus ............................................................. 3-4

4: MANUAL TESTS

Performing Manual Tests ........................................................... 4-35

Printing Manual Measurements ............................................ 4-35

Line Voltage .......................................................................... 4-35

Leakage Current.................................................................... 4-36

ECG Lead Leakage ................................................................ 4-38

Equipment Current ................................................................ 4-42

Resistance............................................................................. 4-42

Isolated Power and Ground Fault Test ................................. 4-44

Toolbox.................................................................................. 4-45

5: AUTOSEQUENCES

What Is an Autosequence ............................................................ 5-1

Description of Standard Safety Autosequences ......................... 5-2

Autosequence Selection ......................................................... 5-3

Standard Safety Autosequence Names .................................. 5-4

Autosequence Device Prompts ............................................... 5-5

Autosequence Steps .................................................................... 5-7

System Line Voltage ............................................................... 5-8

Power Cord Resistance........................................................... 5-8

Leakage Current Measurements............................................. 5-9

Equipment Current Measurement ........................................... 5-9

ECG Performance Waveforms ............................................... 5-10

End-of-Test Prompts.............................................................. 5-11

Test Tag Printer ......................................................................... 5-13

Optional Monitoring Autosequences ......................................... 5-15

Line Voltage Monitor ............................................................. 5-16

Environmental Monitor .......................................................... 5-17

Toolbox Monitors ....................................................................... 5-19

Temperature Monitor ............................................................ 5-19

Humidity Monitor ................................................................... 5-21

6: CUSTOMIZE YOUR MEDTESTER

How to Customize a Preprogrammed Safety Autosequence ...... 6-1

Biomedical Test System

Contents

What You See in an Autosequence..........................................6-2

How to Customize....................................................................6-3

Customizing a Blank Safety Autosequence ................................. 6-7

Test Record Header......................................................................6-7

Customizing Your Autosequence Prompts................................... 6-8

Turning Prompts On and Off .........................................................6-9

Renaming Prompts .....................................................................6-10

Pausing .......................................................................................6-11

Test Tag Configuration...............................................................6-11

Summary of Stored Records....................................................... 6-12

Customizing Bar Code Record Data Entry .................................6-13

Resetting Autosequences to Default Settings........................... 6-14

Printing Your medTester 5000C Configuration ..........................6-15

Customize medTester 5000C Options........................................6-15

7: PERFORMANCE WAVES

Outputting Performance Waves ...................................................7-1

Waveform Groups .........................................................................7-2

Running Waveforms from The WAVES Menu................................7-4

Conducting Waveform Tests in Safety Autosequences...............7-5

8: MEMORY

Introduction .................................................................................. 8-1

Viewing A Single Record ..............................................................8-2

Printing Records ...........................................................................8-2

Print A Single Record............................................................... 8-2

Print A Range of Records.........................................................8-3

Print All Records ......................................................................8-3

Print Records by Type..............................................................8-3

Printing A Summary of Records...............................................8-5

Printing Failed Test Records ...................................................8-5

Configuring Your Printer...............................................................8-5

Deleting Records .....................................................................8-6

Erasing Memory, All Records, and Checklists ........................8-6

Checking Contents of Memory ..................................................... 8-6

Searching for Records .................................................................. 8-7

Searching for Records with Test Failures............................... 8-8

Printing Checklists ..................................................................8-8

Keyboard Shortcut Commands.....................................................8-9

9: DEFIBRILLATOR MODULE

Defibrillator Autosequences......................................................... 9-1

Defibrillator Autosequence Names..........................................9-3

Running Defibrillator Autosequence Tests .................................. 9-5

Pretest Device Prompts ........................................................... 9-6

Test Sequence......................................................................... 9-7

Posttest Prompts................................................................... 9-12

Customizing Defibrillator Autosequences ................................. 9-12

Make Your Own Autosequence ............................................. 9-12

10: IV PUMP MODULE

IV Pump Autosequences............................................................ 10-1

Basic Test Format ................................................................. 10-1

IV Pump Analyzers ................................................................ 10-2

IV Pump Autosequence Names ................................................. 10-4

Running IV Pump Autosequences.............................................. 10-7

Select the Autosequence...................................................... 10-7

Pretest Device Prompts ........................................................ 10-7

IV PUMP TESTS.......................................................................... 10-9

Infutest 2000 Series D........................................................... 10-9

IPT-1 .................................................................................... 10-12

IPT-MC ................................................................................. 10-12

IDA 4 Plus ............................................................................ 10-13

Pressure Test (Infutest, IPT-1, IPT-MC and IDA 4 Plus) ..... 10-17

Posttest Prompts................................................................. 10-18

Customizing IV Pump Tests..................................................... 10-22

Make Your Own Autosequence ........................................... 10-22

Making an Autosequence.................................................... 10-23

Infutest ................................................................................ 10-23

IPT-1 .................................................................................... 10-25

IPT-MC ................................................................................. 10-26

Print Your Autosequence .................................................... 10-26

Reinitialize Factory Default Settings .................................. 10-26

11: MEDCHECK MODULE

Tap Your medTester’s Potential ................................................ 11-1

What’s a Checklist? ................................................................... 11-2

Understanding and Using Checklists ........................................ 11-3

You’ve Made a Checklist—Now What? ...................................... 11-6

Running Checklists in medTester 5000C .................................. 11-6

Find a Checklist..................................................................... 11-7

Run a Checklist ..................................................................... 11-7

Items in a Checklist .............................................................. 11-9

View or Print a Checklist .................................................... 11-12

Remote Control of Fluke Biomedical Testers ......................... 11-13

12: REMOTE OPERATION

Local Versus Remote Mode ....................................................... 12-1

Communicating through medTester Serial Ports ................. 12-1

Communications Settings ..................................................... 12-2

Biomedical Test System

Contents

Local Input Mode ........................................................................12-3

Local Output for Records and Tags ...........................................12-4

Record Output........................................................................12-5

Test Tag Output .....................................................................12-5

Remote Mode.............................................................................. 12-6

Going Remote ........................................................................12-6

File Transfer Protocol ............................................................12-9

Remote Commands List ...........................................................12-12

Port Diagnostics ....................................................................... 12-17

13: THE WEDGE ADAPTER

Features of the Wedge ...............................................................13-1

Serial Port Expansion .................................................................13-2

Keyboard Interface.....................................................................13-2

Port Configuration ......................................................................13-2

Installing the Wedge...................................................................13-4

Disassembly of the medTester 5000C’s Feet and Tilt Bail ...13-5

Attaching the Wedge to the medTester 5000C .....................13-5

Operating the Wedge .................................................................. 13-7

Wedge Port Names ................................................................13-7

Enabling The Wedge ..............................................................13-7

Configuring Wedge Ports .......................................................13-7

Configuring One Port for Two Purposes ..............................13-11

Setting Baud Rates................................................................... 13-11

Setting Output Ports.................................................................13-13

14: ESU MODULE

ESU Autosequences ...................................................................14-1

ESU Autosequence Names ....................................................14-4

Running ESU Autosequence Tests.............................................14-5

Pretest Device Prompts ......................................................... 14-6

Test Sequence ....................................................................... 14-7

ESU Test Types......................................................................14-7

ESU Autosequence Descriptions..............................................14-10

Posttest Prompts ................................................................. 14-14

Customizing ESU Autosequences ............................................ 14-15

Make Your Own Autosequence ...........................................14-15

SPO2 MODULE

SPO2 Autosequences .................................................................15-1

SPO2 Autosequence Names .................................................. 15-4

Running SPO2 Autosequence Tests...........................................15-6

Pretest Device Prompts ......................................................... 15-8

Test Sequence ....................................................................... 15-9

Probe Test............................................................................15-12

For the Oxitest PLUS: .............................................................. 15-13

For CardioSat 100: ................................................................... 15-16

For the Index 2XL:.................................................................... 15-19

Posttest Prompts................................................................. 15-22

Customizing SPO2 Autosequences.......................................... 15-22

Make Your Own Autosequence ........................................... 15-22

Configuring for Your SPO2 Simulator.................................. 15-23

Making an Autosequence.................................................... 15-23

16: TRANSCUTANEOUS PACEMAKER (PACER) MODULE

Pacer Autosequences ................................................................ 16-1

Pacer Autosequence Names ................................................. 16-3

Running Pacer Autosequence Tests.......................................... 16-4

Pretest Device Prompts ........................................................ 16-5

Test Sequence....................................................................... 16-6

Posttest Prompts................................................................. 16-14

Customizing Pacer Autosequences ......................................... 16-15

Make Your Own Autosequence ........................................... 16-15

17: NON-INVASIVE BLOOD PRESSURE (NIBP) MODULE

NIBP Autosequences ................................................................. 17-1

NIBP Autosequence Names .................................................. 17-3

Running NIBP Autosequence Tests........................................... 17-4

Pretest Device Prompts ........................................................ 17-5

Test Sequence....................................................................... 17-6

Posttest Prompts................................................................. 17-11

Customizing NIBP Autosequences .......................................... 17-12

Make Your Own Autosequence ........................................... 17-12

Chapter 1

General Information

In this chapter you will learn how to use this manual, where to get help, and about medTester 5000C Features and Specifications.

SAFETY CONSIDERATIONS

General

This instrument and related documentation must be reviewed for familiarization with safety markings and instructions before you operate the instrument. Refer to the medTester 5000C Operators Manual for operating instructions.

Safety Symbols

The symbol to the left is the operators manual symbol. When

you see this symbol on the instrument, refer to the operators manual.

WARNING! Denotes a hazard. WARNING! calls attention to a procedure,

practice, or the like, which, if not correctly performed or adhered to, could result in personal injury. Do not proceed beyond a WARNING! sign until the indicated conditions are fully understood and met.

CAUTION. Denotes a hazard. CAUTION calls attention to a procedure,

practice, or the like, which, if not correctly performed or adhered to, could result in damage to or destruction of part or all of the instrument. Do not proceed beyond a CAUTION sign until the indicated conditions are fully understood and met.

1-1

medTester 5000C Operators Manual

Introduction

This manual is written for the biomedical technician or clinical engineer responsible for testing hospital equipment, or the plant maintenance technician responsible for maintenance records.

The medTester 5000C is an automated biomedical equipment test system and a portable data acquisition unit that can be controlled with a computer. You can expand the capabilities of the base model by adding modules that let you store test records to memory and print them out.

The medTester 5000C is designed to measure electrical current and resistance as they relate to electrical safety. It measures conditions that might cause injury for compliance with the specifications set forth by ANSI, NFPA, and AAMI.

The medTester 5000C base model automates repetitive tasks with safety autosequences for medical equipment, including lead tests on patient monitors, as well as general electrical devices. You can customize autosequences to meet your specific testing needs.

With the addition of optional modules (for example, the RS-232/Printer module, 100 Record Memory module, Expanded Memory module, and the Waveform/Extended Testing module) your medTester 5000C becomes even more powerful. The Waveform/Extended Testing module gives you additional safety autosequences and performance wave and arrhythmia generation capabilities. Individual defibrillation and IV pump modules offer safety and performance testing autosequences for those devices.

With the Data Transfer module, you can transfer stored equipment test record files to a compatible database program, Computerized Maintenance Management System (CMMS) or Equipment Management System (EMS). The medCheck module enables the downloading of test checklists and the uploading of data to your database, CMMS, or EMS.

Finally, in addition to operating your medTester 5000C in the local mode from the keyboard, bar code port, or the optional external keyboard, you can also operate it from a remote location. Remote operation can take place from a remote personal computer or from a compatible terminal device.

With the Wedge adapter, you can expand the number of serial ports to control several external instruments without changing setups. In addition, you can connect a PC-style keyboard to the Wedge adapter for entering data more easily.

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Biomedical Test System

General Information

The medTester 5000C—reliable safety and performance testing. Capable of managing your entire equipment program.

How to Use This Manual

Your medTester 5000C Operators Manual is designed for you. Whether you are an experienced medTester operator or someone new to medTester, please read this section before using your medTester 5000C.

If You’ve Used The medTester 5000C Before...

The medTester 5000C has been substantially upgraded to best satisfy your needs. It now uses a new firmware release that offers increased reliability and more consistent and stable data storage. RAM in the medTester 5000C is dynamic, and data retrieval is simplified. In addition, some features that you may be using have been enhanced with new features for your convenience. Note in particular these chapters:

• Chapter 1 introduces the medTester 5000C’s enhanced features.

• Chapter 3 shows you how to navigate the medTester’s menus.

• Chapter 6 helps you customize autosequences.

• Chapters 11 and 12 bring you up to date on medCheck checklists

remote operation of the medTester 5000C.

If You’re New to The medTester 5000C...

Welcome to the medTester 5000C! It is the easy-to-use electrical safety and performance analyzer with a high-quality data collection and retrieval system—all designed to make your job easier and more productive. While the ideal recommendation to a new user is to read the entire manual, we know that you want to start using your new medTester now. Before you do, please review Chapters 1 to 3 to learn about the medTester 5000C. Other chapters of interest to you might be:

• Chapter 4 for information about basic medTester 5000C safety

test measurements.

• Chapter 5 for autosequences.

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medTester 5000C Operators Manual

Where to Find Help

If you have questions not answered in this manual, please refer to the following Fluke Biomedical sources:

• medTester 5000C Service Manual, Part No. 2243166.

• Fluke Biomedical Customer Service Department. Telephone

800-648-7952

• Safe current limits for electromedical apparatus, (ANSI/AAMI ES1),

• Standard for Health Care Facilities, (NFPA 99), 1993 Edition,

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Biomedical Test System

General Information

Features

The medTester 5000C is an automated biomedical equipment test system designed for you to do electrical safety and performance testing. With the medTester, you can run customizable automatic sequences of tests, called autosequences. You can print stored test records or upload them to a computer. A computer can operate a medTester 5000C from a remote location. This section defines some basic concepts behind the testing that this manual describes.

Electrical Safety Testing

The medTester 5000C measures electrical current and resistance related to electrical safety. Electrical safety testing is the measurement of electric conditions that could result in injury to operators of that equipment or to patients. All measurements you make with the medTester 5000C comply with specifications set forth by ANSI, NFPA, and AAMI.

Performance Testing

Performance testing verifies that equipment performs to manufacturer specifications. Different types of medical equipment require tests that are unique to its operation—patient monitors, defibrillators, and IV pumps, to name just a few. The medTester 5000C provides ECG waveforms for performance testing of patient monitors. With optional autosequence modules, you can use analyzers to test the performance of defibrillators, IV pumps, electrosurgical units, pulse oximeter analyzers and more.

Manual Measurements

You can always perform safety measurements on any electrical equipment directly from the medTester keyboard. Measurements appear on the display continuously until you escape from the test. Instructions for conducting manual tests are in Chapter 4, Manual Tests.

Automatic Measurements

One of the strengths of the medTester 5000C is the ability to automate testing using autosequences. Autosequences are collections of tests that execute as a group. Ten safety autosequences ship with the medTester 5000C base model, each of which you can customize to meet your needs. With the Waveform/Extended Testing Module, you receive an additional five customizable safety autosequences, five ECG performance waveform and arrhythmia groups, and line monitor and environmental autosequences.

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medTester 5000C Operators Manual

Prompts in the autosequence ask you for information that aids in test reporting. The pretest prompts, for example, can ask you for the model and serial number of the equipment you’re testing, the test location, operator code, and physical condition of the EUT (equipment under test). Posttest prompts can ask you to schedule the next test date, input comments about the tests, or prepare a test tag.

With the Memory Module and RS-232/Printer Module installed on your medTester 5000C, you can store test records to memory and print them from the medTester’s printer port. Additional autosequence modules are available for performance testing defibrillators, IV pumps, and more. See Chapter 5, Autosequences.

Computer Control

You can remotely control your medTester 5000C from a personal computer or compatible terminal device through a serial communication port and appropriate communication software. Once connected and in remote control of the medTester 5000C, you send remote commands to the medTester 5000C to do safety and performance tests, with the results returned to the computer.

Some medTester 5000C users prefer to accumulate the test data for equipment before reporting stored records. Then at their convenience they upload the data to an equipment database program, Computerized Maintenance Management System, or Equipment Management System (EMS) on a computer. This is accomplished through a serial port on the medTester 5000C and the medTester 5000C’s Data Transfer Module. Chapter 12, Remote Operation, discusses the methods you can use to control the medTester 5000C and to manage test data.

If you use other Fluke Biomedical analyzers, such as the Impulse 4000 or IPT1, you can control them with the medTester 5000C. By connecting an analyzer to the medTester 5000C’s COM2 port, you gain a two-way communication link. This link lets the medTester 5000C control the operation of the analyzer. Test data that the analyzer collects is then returned to storage in the medTester 5000C.

medCheck

The medTester 5000C medCheck Module unleashes the power of the medTester 5000C to become the centerpiece of a total equipment management solution. medCheck lets you download checklists from, and upload checklist test data to, your equipment management software system.

1-6

Biomedical Test System

General Information

Checklists are complete sets of preventive maintenance procedures for equipment testing. They can contain prompts to the medTester 5000C user to make physical inspections of the EUT and to take individual safety measurements. A checklist can include one or more safety and performance autosequences that automatically execute. Checklist test record data is then uploaded to the user’s equipment management database program, Computerized Maintenance Management System. See Chapter 11, medCheck Module, for more information.

medTester 5000C Optional Modules

The medTester 5000C offers several modules as options. (See the table later in this chapter.) If your medTester 5000C includes any of these modules, they are listed under the

Enter these menu commands:

1. From the main menu, press:

UTIL menu. To access the menu, do the following:

UTIL

2. Press the right arrow to scroll to the remaining menus.

MODULES

3. Press:

NOTE

For further information about using medTester 5000C menus and function keys, see Navigating the Menus, in Chapter 3, Instrument Familiarity.

Whenever you attempt to select a module that is not installed, this message appears in the display:

MODULE NOT INSTALLED

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medTester 5000C Operators Manual

These modules are software enabled for use by the medTester’s firmware. The firmware is held in EPROM (erasable programmable read-only memory). When you purchase one or more of the modules described below, you receive a 3.5-inch floppy diskette containing the software functions of the module. To load the module software, attach the appropriate serial cable from a communications port on your personal computer to a communications port on the medTester.

Once this connection is made, you receive instructions for enabling the module in the medTester 5000C’s EEPROM (electrically erasable programmable read-only memory).

medTester 5000C Modules

medTester

5000C

Module Name

RS-232/Printer

Memory— 100 Records

Memory— Expanded

Waveform/ Extended Testing

Functions Enabled medTester

Prerequisites for Use of

Module

• Use of COM1 and

COM2 serial ports.

• Use of the parallel

printer port.

• Test record

storage.

• Storage of

autosequence and medCheck data.

• Five (5) additional

safety autosequences.

• ECG performance

waveforms.

• ECG arrhythmias.

• None • Remote operation of the

• RS-232/Printer Module • Storing of test records.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• RS-232/Printer Module.

• Memory—100 Records

Module.

Required for...

medTester 5000C from a personal computer or compatible terminal device.

• Two-way communication

between the medTester 5000C and a Fluke Biomedical analyzer or tester.

• Input from an optional

keyboard, bar code scanning gun.

• Printing test record output.

• Autosequence testing.

• Use of medCheck.

• Adding more customized

safety autosequences.

• Outputting ECG waveforms to

patient monitors.

• Outputting ECG arrhythmias to

patient monitors.

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• Line monitor test.

• Environmental test.

• Periodic measurements of line

voltage.

• Measuring ground potential

and resistance between a common ground point and multiple points in a room.

Biomedical Test System

General Information

medTester 5000C Modules

medTester

5000C

Module Name

Data Transfer

medCheck

Defibrillator

IV Pump

Functions Enabled medTester

Prerequisites for Use of

Module

• File Transfer

Protocol used to transfer checklists into and out of the medTester 5000C.

• Checklists • RS-232/Printer Module.

• Defibrillation

autosequences.

• IV Pump

autosequences.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

• Data Transfer Module.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

• Data Transfer Module.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

Required for...

• Checklist usage.

• Communicating checklists

between an equipment management database system and the medTester 5000C.

• 20 autosequences for testing

defibrillators with the Fluke Biomedical Impulse 4000 defibrillator analyzer.

• Including defibrillator

autosequences in checklists.

• 10 autosequences for testing

IV pumps with the Fluke Biomedical pump tester.

• Including IV pump

autosequences in checklists.

• Data Transfer Module.

ESU

• ESU

autosequences.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

• Data Transfer Module.

• 10 autosequences for testing

electrosurgical units with Fluke Biomedical analyzers.

• Including ESU autosequences

in checklists.

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medTester 5000C Operators Manual

medTester 5000C Modules

medTester

5000C

Module Name

SPO2

Pacer

NIBP

Functions Enabled medTester

Prerequisites for Use of

Module

• SPO2

autosequences.

• Transcutaneous

Pacemaker autosequences.

• Non-Invasive Blood

Pressure autosequences.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

• Data Transfer Module.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

• Data Transfer Module.

• RS-232/Printer Module.

• Memory—100 Records

Module.

• Expanded Memory

Module.

• Data Transfer Module.

Required for...

• 10 autosequences for testing

SPO2 monitors with Fluke Biomedical analyzers.

• Including SPO2

autosequences in checklists.

• 10 autosequences for testing

transcutaneous pacemakers with the Fluke Biomedical Impulse 4000.

• Including Pacer

autosequences in checklists.

• 10 autosequences for testing

Non-Invasive Blood Pressure monitors with the Fluke Biomedical CuffLink.

• Including NIBP pump

autosequences in checklists.

Bar Code (hardware)

• Scanning of bar

code data into test record.

• None • Scanning of data.

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Biomedical Test System

General Information

Features

• Fully automated electrical safety testing

• 12–lead ECG/arrhythmia simulation

• Dedicated “autosequence” testing for performance testing of

defibrillators, infusion pumps, etc.

• 20-ampere testing with GFCI protection

• Meets ANSI/AAMI ES1–1993 test load requirements

• Load current measurement

• Programmable test limits

• Automatic record storage

• Bar code compatibility

Optional Accessories

• External RS-232 Keyboard

• Bar Code Scanner (requires Wedge adapter)

• Wedge Adapter (eight 25-pin serial ports as well as AT or PS/2

keyboard port)

• Mini PC-Style Keyboard (AT or PS/2, requires Wedge adapter)

• Label Printer

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medTester 5000C Operators Manual

medTester 5000C Instrument Specifications

Line Voltage and Measurements

• Hot to Neutral.

• Neutral to Ground.

• Hot to Ground.

• Range: 200.0 V RMS.

• Accuracy: ±5% of range.

Leakage Current

Leakage current is measured through a 1 kΩ AAMI load RMS or DC measured and displayed in microamperes. These tests can be thought of as measuring the voltage, in millivolts across the same load.

Leakage Current Measurements

• Case external.

• Case internal.

• External.

• ECG—Leads are RL, RA, LA, LL, and V1-V6 tied together:

1. To ground, all leads or individual leads.

2. Lead to lead, individual leads to all other leads together.

3. Lead isolation (RMS only), all leads or individual leads.

This test is with line voltage applied from the lead(s) to ground, current limited by 120 kΩ.

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Note

If you receive abnormally high leakage current measurements with V1-V6 leads tied together, you can inspect individual V leads by removing the other leads. This procedure allows you to isolate the lead with a high leakage current reading.

Biomedical Test System

General Information

AAMI Load

• Simulated patient load recommended by the Association for the

Advancement of Medical Instrumentation (AAMI), Safe Current Limits Standard (ANSI/AAMI ES1-1993) (revision of the earlier ANSI/AAMI ES1-1985 and SCL-12/78).

• AAMI Load drawing:

LEAKAGE CURRENT INPUT

1 KΩ

10 KΩ

0.015

100 Ω

OUTPUT TO METER CIRCUIT

• Frequency Response: ANSI/AAMI ES1-1993

• Test Load Impedance: 1000 ohms +/- 1% @ DC

(ANSI/AAMI ES1-1993)

• Ranges—2000 µA and 200 µA.

• Range—20.00 A RMS.

• Accuracy—± 1.0% of reading DC and from 48 Hz to 1kHz

± 2.5% of reading 1 kHz to 100 kHz ± 5.0% of reading 100 kHz to 1 MHz

Equipment Current

Equipment current measures the current used by the EUT plugged into the test receptacle:

• Range—20.00 A RMS.

• Accuracy—±5% of range.

Resistance

Resistance tests measure resistance with the four-terminal test method:

• Measurements—Power cord and external.

• Range—2 Ω.

• Accuracy—±1% of range.

• Test Current—100 mA

Isolated Power

This feature allows the use of the Fluke Biomedical Model 202A Isolation Test Module to make current measurements on an isolated power system. For more information, see Chapter 4, Manual Tests.

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medTester 5000C Operators Manual

Toolbox

Toolbox allows for the use of external measurement adapters for:

• Tachometer—with a range of 100 to 20,000 RPM.

• Temperature—with a range of 0 to 200°F or

0 to 100°C.

• Humidity—ranging from 15% to 90% relative.

For more information about Toolbox, see Chapter 4, Manual Tests.

Test Receptacle

The medTester 5000C has a test receptacle on the top panel into which the equipment under test (EUT) is plugged. The test receptacle supplies power to the EUT. The EUT must be powered through the test receptacle whenever you measure the following:

• Leakage current—All case and ECG lead measurements.

• Equipment current.

• Power cord resistance.

Test receptacle power is normal except during case and ECG leakage tests (not including isolation tests). For these tests you can set the power to the following conditions, each of which is indicated by annunciator LEDs on the top panel:

• Ground—closed or open.

• Polarity—normal or reversed.

• Neutral—closed or open.

Note

During case internal leakage, ground is always open.

Current is supplied at a maximum instantaneous level of 20 amps.

CSA Label

On the back of the medTester 5000C, you can see a label which specifies the conditions under which the test receptacle can operate:

• 1840 VA, 16 A continuous operation.

• Up to 19 A for no longer than two (2) minutes. Then powered off

for eight (8) minutes (20 percent of duty cycle).

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Biomedical Test System

General Information

Ground Fault Circuit Interrupter

The test receptacle is protected by a ground fault circuit interrupter. In the event of a fault in the EUT (when the test receptacle is powered on) which causes a current imbalance in the hot and neutral lines of greater than 5 mA, the interrupter triggers. Under this condition, the interrupter turns off the test receptacle and all test connections, and the medTester prompts you to correct the fault and continue.

Performance Waveforms

The medTester 5000C generates ECG waves and arrhythmias to test the performance of patient monitors in those medTesters that have the Waveform/Extended Testing Module installed. You can find information about conducting waveform tests in Chapter 7, Performance Waves. Specifications for waveforms and arrhythmias are:

ECG Performance Test Waves (Lead I, Vp-p)

• Square Wave—2 Hz, 1 mV

• DC Pulse—4 Seconds, 1 mV

• Sine Wave—0.5, 10, 40, 60, and 100 Hz, 1 mV

• Square Wave—1 kHz, 1 mV

• Triangle—2 Hz, 1 mV

• CMRR—60-Hz sine wave with 1–kΩ imbalance in LA

• Normal Sinus—30, 60, 120, 240 BPM.

Arrhythmias

• Atrial fibrillation

• Second degree A-V Block, Type 1

• Premature atrial contractions

• Missed beat at 80 and 120 BPM

• PVC 1 left

• PVC 2 right

• Multifocal PVCs

• PVC 1, R on T

• A pair of PVCs

• Run of 5 PVCs

• Run of 11 PVCs, MF

• Right bundle branch block

• Ventricular tachycardia

• Ventricular fibrillation

• Asystole

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medTester 5000C Operators Manual

General Specifications

Parameter Specification

Power Requirement: 115 V ±10%, 60 Hz only

Temperature Ranges:

Display: 80-character (40 x 2 lines) backlit Liquid

Weight: 5 kg (11 lb)

Dimensions: 25.4 cm L x 35.0 cm W x 10.2 cm H

ECG Connections

Waveforms generated for performance testing can be output through the binding posts on the medTester 5000C’s top panel or the ECG High-Level Output located on the medTester 5000C’s back panel.

Operating: 15° to 35°C (59° to 95°F) Storage: 0° to 50°C (32° to 122°F)

Crystal Display

(10 in L x 13.8 in W x 4 in H)

ECG Binding Posts

• 10 posts, American Hospital Association color–coded,

• RL, RA, LA, LL, V1-V6,

• Compatible with both 3.2–mm and 4.0–mm pins and disposable

snap electrodes.

High-Level ECG Output

• ¼" phone jack,

• 1–volt nominal.

Data Input and Output

• Top panel keyboard (QWERTY-type)—48 characters.

• Bar code reader (optional).

• RS-232C serial ports (2) for computer interface or auxiliary test

instrument control, expansion to an additional eight (8) ports with the Wedge Adapter.

• Parallel printer port (1).

RS-232C Serial Interface Parameters

• Baud—300, 600, 1200, 2400, 4800, 9600, 19200.

• Stop Bits—1.

• Parity—Off.

• Data Length—8 bits.

Real Time Clock

Real time clock is kept internal to the instrument.

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Biomedical Test System

General Information

Accessories

Standard

• 20/15–amp Adapter

• Two Kelvin Cable

• Two Ground Pin Adapters

• Operator Manual

• Accessory Pouch

Optional

• Interface Cable, medTester to

• Interface Cable, medTester

5000C to Patient Simulator

• Interface Cable, AT-Style PC

Adapter Cable

• Interface Cable, medTester to

Impulse 3000

• Interface Cable, medTester to

Impulse 4000

• Interface Cable, medTester to

Oxitest Plus/Plus7

• Interface Cable; medTester to

Infutest 2000 Series D

• Interface Cable; medTester

Wedge to IDA 4 Plus

• Interface Cable; medTester to

RF303RS. Requires adapter

2391789.

• Adapter; for medTester to

RF303RS with 2238659

• Interface Cable, medTester to

PC/454A/CuffLink; Impulse 4000 to PC

• Interface Cable, medTester to

SigmaPace™ 1000/402A/PC/ IPT-MC/Index 2XL/IDA 4 Plus (IDA 4 Plus to Wedge use

2201042); Impulse 4000 to PC

• Interface Cable, medTester to

IPT-1

• Interface Cable, medTester to

IPT-MC

• Printer Cable, medTester to

TLP-1 & TLP-2 Test Label Printer

2195732

2392617

2242165

2243153

2392871

RS-232; Female DB25 to Female DB25

RS232; Right Angle DIN to Female DB25

RS232; DB9 to DB25, for use w/2392186

RS232, Straight DIN to Female DB25

RS232; Female DB25 to Female DB25

RS232; Female DB25 to mini DIN

RS232; Female DB25 to Female DB25

RS232; Female DB9 to Female DB25

RS232; Male DB9 to Female DB9

Adapter; Male DB9 to Female DB25

RS232; Female DB25 to Female DB25

RS232; Female DB25 to Female DB9

RS232; Female DB25 to Male DB25

RS232; Female DB25 to Female DB9*

Serial Cable;

Part #

2392186

2200808

2199233

2199346

2200252

2237730

2237604

2201042

2238659

2391789

2392186

2200102

2392251

2201042

2200717

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medTester 5000C Operators Manual

Optional (continued)

• Printer Cable, medTester to

standard PC printer

• TLS Test Tag Printer Kit

Serial Cable; Male DB25 to Centronics

Printer, white and yellow

Part #

2200577

2245515 vinyl labels, black vinyl printer ribbon, serial cable, adapter and US power source

• TLP-1/2 Printer Paper, Yellow

• TLP-1/2 Printer Paper, Blue

• TLP-1/2 Printer Paper, White

• TLS Label Roll Vinyl White

• TLS Label Roll Vinyl Yellow

• TLS Label Roll Vinyl Orange

• TLS Label Roll Vinyl Red

• TLS Label Roll Vinyl Blue

• TLS Label Roll Vinyl Green

• TLS Printer Ribbon Vinyl

2220045

2220038

2220023

2243893

2243902

2243916

2243925

2243933

2243940

2243957

Black

• Adapter DB-9 M to DB-25 F

• Service Manual

• Wedge Adapter

• PC Wedge Laser Barcode Gun

• Mini PC-style Keyboard

• Multi-purpose Hard-Sided

Carrying Case (contains “Pick & Pluck” foam)

• Multi-purpose Hard-Sided

Carrying Case (contains “Pick & Pluck” foam)

* Part #2200102 will interface with the IPT-MC directly for the medTester ONLY. Part #2201042 will interface with the IPT-MC directly to medTester OR through the Wedge accessory.

2391789

2243166

2245264

2245092

2245061

Fits medTester with Wedge (29” L x 18” W x 10½” H)

2248606

Fits medTester without Wedge (19” L x 14” W x

2248587 7¾” H)

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