Welch Allyn CP-200 User manual

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Page 1

CP 200™ 12-Lead Resting

CP200

Electrocardiograph

Directions for Use

Page 2

ii Welch Allyn CP 200 Electrocardiograph

Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician.

Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn, Inc., and CP 200 and CardioPerfect are trademarks of Welch Allyn, Inc.

SD is a trademark of Toshiba.

Software in this product is Copyright 2005, Welch Allyn, Inc., or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title and ownership of the software remains with Welch Allyn or its vendors.

For information about any Welch Allyn product, please call Welch Allyn Technical Support:

USA 1 800 535 6663

+ 1 315 685 4560

Canada 1 800 561 8797 China + 86 216 327 9631

European Call Center + 353 46 906 7790 France + 33 15 569 5849

Germany + 49 747 792 7186 Japan + 81 33 219 0071

Latin America + 1 315 685 2644 Netherlands + 31 15 750 5000

Singapore + 65 6419 8100 South Africa + 27 11 777 7555

United Kingdom + 44 207 365 6780 Sweden + 46 85 853 6551

Australia + 61 29 638 3000

800 074 793

Reorder Number (multi-language CD): 401151 Mat. Number (manual only): 701557, Ver: D

Welch Allyn 4341 State Street Road, PO Box 220 Skaneateles Falls, NY 13153-0220

www.welchallyn.com

Printed in USA

Page 3

Contents

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

iii

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Standard Features & Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Controls, Indicators, and Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

About the Main Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Moving Through the Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

About the Patient Cable and Leads. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Using the Electrocardiograph Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

General Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

General Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Getting Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2 - Setting Up the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . 19

Inspecting the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Connecting the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Loading the Thermal Chart Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Powering the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Verifying Proper Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3 - Reviewing the System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

“System Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Reviewing the Device Configuration Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Reviewing the Device Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Reviewing the Medication List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Reviewing the History List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4 - Reviewing the ECG Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

“ECG Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Reviewing the Auto Report Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Reviewing the Format Settings for Auto Reports. . . . . . . . . . . . . . . . . . . . . 37

Reviewing the Interpretation and Copy Settings for Auto Reports. . . . . . . . 39

Reviewing the Patient Data Fields Available for Auto Reports . . . . . . . . . . . 40

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iv Contents Welch Allyn CP 200 Electrocardiograph

Reviewing the Rhythm Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Reviewing the Miscellaneous ECG Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5 - Performing ECG Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Connecting the Leads to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Recording an Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Recording a Normal Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Recording a Stat Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Recording a Rhythm ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Searching for Saved Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Adjusting the ECG Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

6 - Performing Administrative Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Managing Saved Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Managing the Scheduled Patients List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Managing Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Working With the User List and User Login. . . . . . . . . . . . . . . . . . . . . . . . . 70

Working With the Audit Trail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

7 - Maintaining the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . 73

Inspecting the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Cleaning the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Testing the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Recharging a Fully Discharged Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Replacing the Battery (DC) Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Replacing the AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Storing the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Discarding the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

8 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Problem-Solving Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

A - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

B - EMC Guidance and Manufacturer’s Declarations . . . . . . . . . . . . . 91

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

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Introduction

About This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Standard Features & Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Controls, Indicators, and Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

About the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Moving Through the Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

About the Patient Cable and Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Using the Electrocardiograph Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Getting Help. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

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2 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

About This Manual

This manual is written for clinical professionals with a working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

Before using the CP 200 electrocardiograph for clinical applications—or before setting up, configuring, troubleshooting, or servicing the electrocardiograph—you must read and understand this manual and all other information accompanying the electrocardiograph and related options or accessories.

Product Overview

The Welch Allyn CP 200 electrocardiograph can display, print, save, and send ECGs electronically. It features a full alphanumeric keyboard, a color display to preview ECGs and edit settings, storage for up to 50 ECG and 50 spirometry records, full-size userprogrammable reports, and the ability to operate on either battery or AC power.

For centralized ECG data storage, the CP 200 electrocardiograph can connect to a Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records.

For details, see the following sections:

• “Standard Features & Benefits” on page 3

• “Options” on page 4

• “Specifications” on page 89

Intended Use

The CP 200 electrocardiograph is specifically intended for acquiring, viewing, storing, and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained healthcare providers.

The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements for adults. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.

The electrocardiograph provides an optional interface to a pulmonary function device.

Communication of ECG and spirometry data with a central data-management system is optional.

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Directions for Use Chapter 1 Introduction 3

Indications for Use

The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.

The 12-lead interpretive algorithm provides a computer-generated analysis of potential patient abnormalities which must be used only as guidance for consideration by qualified physicians, together with other relevant clinical information, for purposes of making diagnoses.

Contraindications

The 12-lead interpretive algorithm is not intended for use on pediatric patients.

Standard Features & Benefits

Full alphanumeric keypad

Enter or search for patient information quickly and easily.

Color LCD display

View and adjust the ECG waveforms prior to printing, to save time and paper. With spirometry option, also view patients’ spirometry efforts and results.

Storage for up to 50 ECG and 50 spirometry records

Review, edit, print, or save recent records.

Unlimited storage on SD™ memory cards

Use SD memory cards to save as many ECG or spirometry records as you like. (Cards are not included.)

Battery operation

Use the electrocardiograph almost anywhere. On battery power, you can print up to 100 ECGs continuously before needing to recharge.

User-definable ECG report formats

Customize one or two formats for efficient reporting.

Removable leads for ECG patient cable

Replace leads individually if needed.

Compatibility with CardioPerfect workstation software

Store and manage data electronically by transferring records to a Welch Allyn CardioPerfect workstation in one of two ways:

• via an SD memory card (card not included)

• via a hardwired connection (cable not included)

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4 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Options

These options are available both for initial purchases and for upgrades.

• Spirometry

With a disposable, single-use flow transducer, the optional spirometer performs FVC and SVC tests.

• Automatic ECG interpretation

The optional MEANS interpretation algorithm, developed by the University of Rotterdam in the Netherlands, provides automatic analysis of ECG tests. For more information, see the MEANS Physicians' Manual on the CD that came with your electrocardiograph.

•Carts

Two specially designed carts are available for convenient transport and use of the electrocardiograph, as shown here with the optional cable arm and shelf.

Figure 1. Office Cart Figure 2. Hospital Cart

Cable arm and shelf (optional)

Free-motion plastic wheels

Cable arm and shelf (optional)

Durable, highquality, rubber wheels with locks

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Directions for Use Chapter 1 Introduction 5

Accessories

To order accessories, call Welch Allyn. For phone numbers, see page ii.

Item Customer Order Number Quantity

Resting tab electrodes Resting tab electrode adaptors Thermal chart paper (1 case = 5 pads, 200 sheets each) Welch cups Limb lead clamps, IEC Limb lead clamps, AHA

Patient cable (Figure 12 on page 12)

•AHA

•IEC

• IEC, vacuum adapter

Lead wires (10 wires per set)

• AHA banana

• IEC banana

• AHA pinch

• IEC pinch

Battery (Figure 47 on page 77) Dust cover

Carts

• Utility cart

• Office cart (Figure 1 on page 4)

•Hospital cart (Figure 2 on page 4)

• Cable arm & shelf option (page 4)

Connectivity kit to the CardioPerfect workstation Interpretation upgrade option

45008-0000 58581-0000 94018-0000 RE-ELEC-CUP RE-ELEC-CLP 401432

400293 400294 401128

401129 401122 401123 401124

100660 401428

08265-0000 401393 401394 401161

100638 100623

1000

1 case

6 4 4

1 1 1

1 set 1 set 1 set 1 set

1 1

1 1 1 1

1 1

Spirometry option 100400 1

Product information

• Electrode placement wall poster 71300-0000 1

• CP 200 12-Lead Resting Electrocardiograph Directions for Use

• CP 200 product information multi-language CD 401151 1

701557 1

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6 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Controls, Indicators, and Connectors

This section describes the controls, indicators, and connectors that are part of the electrocardiograph.

Figure 3. Top

Softkeys and functions keys See Figure 8 on page 9.

Keyboard See Figure 1 on page 8.

Figure 4. Back

AC power inlet

Equipotential stud

AC fuses

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Directions for Use Chapter 1 Introduction 7

Figure 5. Right Side

Com port B

(for USB cable)

Figure 6. Front

SD memory card

slot

Com port A

(for patient cable)

Spirometry port

Figure 7. Left Side

Paper tray latch

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8 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Table 1. Keyboard

Key Function

A. On/Off See “Powering the Electrocardiograph” on page 22.

B. Backspace Deletes the character to the left of the cursor.

C. Menu See “About the Main Menu” on page 10.

D. Help See “Getting Help” on page 18.

E. Navigation arrows See “Moving Through the Menus” on page 11.

F. Enter See “Moving Through the Menus” on page 11.

G. Space Enters a space.

H. Shift Capitalizes letters.

I. Tab Moves through the data-entry fields.

J. Green LED Lights up when the electrocardiograph is connected to AC power.

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Directions for Use Chapter 1 Introduction 9

Figure 8. Softkeys and Function Keys

Softkeys

These softkeys display text or images that correspond to the unlabeled buttons below them. The content changes from screen to screen.

Softkey buttons

These buttons activate the functions displayed above them. If a softkey is blank, pressing its

Auto ECG Spirometry Rhythm ECG Stop/Cancel OK

button has no effect.

Function Keys

Auto ECG

Begins Auto ECGs, normal and stat. See “Recording an Auto ECG” on page 49.

Spirometry

Begins spirometry tests. See spirometry manual.

Rhythm ECG

Begins Rhythm ECGs. See “Recording a Rhythm ECG” on page 56.

Stop/Cancel

Stops any current activity. See “Moving Through the Menus” on page 11.

Accepts data that you have entered, or chooses a highlighted item. See “Moving Through the Menus” on page 11.

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10 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

About the Main Menu

The main menu appears when you press the Menu key .

Figure 9. Main Menu

Main Menu

1 Test Directory 2 Scheduled Patients 3 ECG Settings 4 Spirometry Settings 5 System Settings 6 Edit Medication List 7 Edit History List 0 Exit

9:17AM Oct 16 05

Submenu Purpose Procedure

Test Directory View, change, print, or send saved tests. See “Managing Saved Tests” on page 64.

Scheduled Patients View the scheduled patients list, add

patients to the list, or delete patients from

See “Managing the Scheduled Patients List” on page 68.

the list.

ECG Settings Review or change ECG settings: Auto

Report format, Rhythm Report format, and

See “Reviewing the ECG Settings” on page 33.

so on.

Spirometry Settings Review or change spirometry settings:

display settings, print settings, and so on.

System Settings Review or change system settings: device

configuration, device info, user setup, and so on.

Edit Medication List Edit the list of medication choices available

to choose during patient data entry.

Edit History List Edit the list of clinical conditions available to

choose during patient data entry.

See spirometry manual.

See “Reviewing the System Settings” on page 25.

See “Reviewing the Medication List” on page 30.

See “Reviewing the History List” on page 31.

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Directions for Use Chapter 1 Introduction 11

Moving Through the Menus

Figure 10. Standard Menu Figure 11. Parent Menu With Submenu

Edit Auto Report 1

1 Format

2 Interp Settings 3 Patient Data 0 Previous Menu

9:17AM Oct 16 05

Format

1 Lead Arrangement 2 Rhythm Lead 1 3 Rhythm Lead 2 4 Rhythm Lead 3 5 Extended Measurements 6 Average Cycles 0 Previous Menu

Desired Actions Keys to Press

To move up or down a list or (keyboard or softkey arrows)

To open a standard menu (Figure 10)

or or

or item’s number or letter

To move from parent menu to submenu on same screen (Figure 11)

To perform an action

or To accept data To check or uncheck a checkbox

9:17AM Oct 16 05

3x4 3x4 +1R 3x4 +3R 6x2

12x1

6x2 50 mm/s 6x2 Ext. No Print

To return to parent menu from submenu on same screen (Figure 11) or

(To select the highlighted submenu item.)

(To make no change.)

To move back through the menus or zero key

To move through data-entry fields

To return to the ECG Preview screen from a standard menu (Figure 10)

Note Keyboard and softkey arrows work the same way.

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12 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

About the Patient Cable and Leads

The patient cable processes the patient’s ECG data and transmits it to the electrocardiograph. To make handling convenient, the ten leads are arranged to point toward the appropriate parts of the body. The cable rake, which slides easily, prevents the chest leads from tangling.

Figure 12. Patient Cable and Leads

Chest leads

Left arm lead

Cable rake

Right arm lead

Left leg lead

Electrocardiograph connector

Right leg lead

Page 17

Directions for Use Chapter 1 Introduction 13

Symbols

The symbols illustrated on the following pages may appear on the electrocardiograph, on the packaging, on the shipping container, or in this manual.

Documentation Symbols

WARNING Indicates conditions or practices that could lead to illness, injury, or death.

Caution In this manual, indicates conditions or practices that could damage the equipment or other property.

Caution On the product, means “Consult accompanying documentation.”

Shipping, Storing, and Environment Symbols

-20°C

EC REP

This end up Keep dry

Fragile Relative humidity limit

+49°C

Temperature limits Altitude limits

Certification Symbols

Meets essential requirements of European Medical Device Directive 93/42/EEC

European Regulatory Manager Welch Allyn LTD. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: 353-46-90-67700 Fax: 353-46-90-67756

N344

Complies with applicable U.S. and Canadian medical safety standards

Australian registered importer

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14 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Operation Symbols

For details on the keys, see Figure 1 on page 8.

On/standby (off) Help

Navigation arrows Backspace

Enter Shift

Auto ECG Menu

Rhythm ECG Stop/Cancel

Spirometry OK

Spirometry port Com port B

(for USB cable)

T2.0A/250V

SD memory card slot Com port A

(for patient cable)

Alternating current Battery charge level

Dangerous voltage Direct current

AC fuse replacement information Ground equipotential

Do not reuse.

Do not dispose of this product as unsorted

Sealed lead-acid battery

Recycle. municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see

www.welchallyn.com/weee, or contact

Welch Allyn Customer Service at +44 207

Defibrillation-proof Type CF applied parts.

(While the electrocardiograph is safety-rated

“CF” for direct cardiac contact, it is not

intended to be connected directly to the

patient’s heart. Only surface contact with the

patient’s skin is intended.)

Type BF applied part

365 6780.

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Directions for Use Chapter 1 Introduction 15

Using the Electrocardiograph Safely

Before using or servicing the electrocardiograph, you must read and understand the following safety-related information.

General Warnings

The following warning statements apply to electrocardiograph use in general. Warning statements that apply specifically to particular procedures, such as connecting the patient cable or performing an ECG test, appear in the corresponding sections of the manual.

Warning statements indicate conditions or practices that could lead to illness, injury, or death.

Warnings Related to the Environment

WARNING To ensure patient and device safety, leave 5 feet (1.5 meters) of

open area around the patient.

WARNING To avoid a possible explosion, do not use the electrocardiograph in the presence of flammable anesthetics: mixtures containing air, oxygen, or nitrous oxide.

WARNING When transporting the electrocardiograph on a cart, tuck the patient cable away from the wheels so that it does not present a hazard.

Warnings Related to Accessories and Other Equipment

WARNING For operator and patient safety, peripheral equipment and

accessories that can come in direct patient contact must be in compliance with all appropriate safety, EMC, and regulatory requirements. See “EMC Guidance

and Manufacturer’s Declarations” on page 91.

WARNING All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (for example, IEC 60950), as appropriate to the device. Connecting additional devices to the electrocardiograph may increase chassis or patient leakage currents. To maintain operator and patient safety, consider the requirements of IEC 60601-1-1. Measure the leakage currents to confirm that no electric shock hazard exists.

WARNING The electrocardiograph has not been designed for use with highfrequency (HF) surgical equipment and does not protect against hazards to the patient.

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16 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Warnings Related to Using the Electrocardiograph

WARNING This device captures and presents data reflecting a patient’s

physiological condition. When reviewed by a trained physician or clinician, this data can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

WARNING To avoid serious injury or death, take these precautions during patient defibrillation:

• Avoid contact with the electrocardiograph, patient cable, and patient.

• Verify that the patient leads are properly connected. See “Connecting the

Patient Cable” on page 20.

• Place defibrillator paddles properly in relation to electrodes.

• After defibrillation, pull each patient lead out of the patient cable and inspect the tips for charring (black carbon marks). If there is any charring, the patient cable and individual leads must be replaced. If there is no charring, fully reinsert the leads into the patient cable. (Charring can occur only if a lead is not fully inserted into the patient cable before defibrillation.)

WARNING To prevent the spread of infection, take these precautions:

• Dispose of single-use components (for example, electrodes) after using them once.

• Regularly clean and disinfect all components that come in contact with patients. See “Cleaning the Equipment” on page 74.

• Avoid ECG testing for patients with open, infectious sores.

WARNING Avoid positioning any leads or cables so that they could easily trip someone or become wrapped around a patient’s neck.

WARNING Satisfactory maintenance procedures must be implemented, or equipment failure and health hazards may result.

WARNING Only qualified service personnel should attempt to repair the electrocardiograph. In case of a malfunction, call Technical Support and precisely describe the problem. For phone numbers, see page ii.

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Directions for Use Chapter 1 Introduction 17

General Cautions

The following caution statements apply to electrocardiograph use in general. Caution statements that apply specifically to particular procedures, such as connecting the patient cable or performing an ECG test, appear in the corresponding sections of the manual.

Caution statements indicate conditions or practices that could damage the equipment or other property.

Caution When removing the electrocardiograph from storage, allow it to thermally stabilize to surrounding environmental conditions before using it.

Caution To prevent possible damage to the keypad, do not use sharp or hard objects to press keys. Only use fingertips.

Caution Do not expose the patient cable to strong ultra-violet radiation.

Caution Do not pull or stretch the patient cable. Doing so could result in

mechanical or electrical failures. Form the patient cable into a loose loop before storing.

Caution Avoid positioning the patient cable where it might get pinched or stepped on. If the cable’s impedance is altered, measurements might no longer be accurate, and repair might be necessary.

Caution Using the equipotential terminal for anything but grounding purposes may contribute to damage of the device.

Caution Use only parts and accessories supplied with the device and available through Welch Allyn. The use of accessories other than those specified may result in degraded performance of this device.

Caution Portable and mobile RF communications equipment can affect the performance of the electrocardiograph.

Caution The electrocardiograph meets the Class A requirements of IEC 606011-2:2000 regarding incidental emission of radio frequency interference. As such it is suitable for use in commercial grade electrical environments. If the electrocardiograph is used in residential grade electrical environments and you experience incidental interference with other equipment that uses radio frequency signals to operate, minimize the interference as described under

“EMC Guidance and Manufacturer’s Declarations” on page 91.

Caution Other medical equipment—including but not limited to defibrillators, ultrasound machines, pacemakers, and other stimulators—may be used simultaneously with the electrocardiograph. However, such devices may disturb the electrocardiograph signal.

Caution The power cord must be disconnected from AC power before cleaning, maintaining, or servicing.

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18 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Getting Help

You can get help with the electrocardiograph in a variety of ways beyond this manual.

• Press the Help key from the ECG Preview screen or Lead Off screen for a list

of topics available to print.

• Review the other information that came with the electrocardiograph. For list, see

“Product information” on page 5.

• Contact Welch Allyn. For phone numbers, see page ii.

Page 23

Setting Up the Electrocardiograph

Inspecting the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Connecting the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Loading the Thermal Chart Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Powering the Electrocardiograph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Verifying Proper Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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20 Chapter 2 Setting Up the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Inspecting the Electrocardiograph

1. Look for obvious signs of shipping damage. If you find any damage, contact Technical Support. For phone numbers, see page ii.

2. Verify that you have received all appropriate options and accessories. See “Options” on page 4 and “Accessories” on page 5.

Connecting the Patient Cable

WARNING Conductive parts of the patient cable, electrodes and associated connections of defibrillation-proof Type CF applied parts, including the neutral conductor of the patient cable and electrode, should not come into contact with other conductive parts, including earth ground.

WARNING To avoid injury to the patient or damage to the device, never plug patient leads into any other device or wall outlet.

1. Insert all leads into their proper positions, as labeled on the connectors.

Insert connectors fully so that no part of the metal ring remains exposed. For example, see Figure 13. (To see the whole patient cable with all leads inserted, see Figure 12 on page 12.)

WARNING Failure to insert all connectors fully may result in a loss of energy being delivered to the patient during defibrillation and damage to the patient cable itself. For other warnings related to defibrillation, see page 16.

2. Plug the patient cable into the port on the front of the electrocardiograph. See Figure 14.

Figure 13. Inserting the Leads Figure 14. Plugging in the Connector

Metal ring

Page 25

Directions for Use Chapter 2 Setting Up the Electrocardiograph 21

Loading the Thermal Chart Paper

1. Squeeze the latch. Pull the paper door to the left. See Figure 15.

If any paper remains in the tray, remove it.

2. Remove the outer packaging, including the cardboard bottom, from a new pack of paper. Pull the top sheet back so that the paper’s grid side faces up and the Welch Allyn name is on the bottom of the paper.

3. Slide the paper into the tray. See Figure 16.

If humidity is high, remove up to 10 sheets so that the paper fits properly.

4. Lay the top sheet over the paper door. Push the door to the right until it clicks. See Figure 17.

Figure 15. Opening the Paper Door Figure 16. Loading the Paper

Latch

Figure 17. Closing the Paper Door

Tea r bar

Paper tray

Tips for handling thermal paper:

• Store in a cool, dry, dark place.

• Avoid exposure to bright light or UV sources.

• Avoid exposure to solvents, adhesives, or cleaning fluids.

• Do not store with vinyls, plastics, or shrink wraps.

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22 Chapter 2 Setting Up the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Powering the Electrocardiograph

The electrocardiograph can run on AC or battery power.

WARNING To ensure that electrical safety is maintained when using AC power, the device must be plugged into a hospital-grade outlet.

WARNING Where the integrity of external protective earth conductor arrangement is in doubt, use battery power.

Caution Medical electrical equipment needs special precautions regarding EMC and must be installed and used according to the information provided in “EMC

Guidance and Manufacturer’s Declarations” on page 91.

To Connect to AC Power

Plug one end of the power cord into the electrocardiograph’s AC power inlet. Plug the other end into an AC outlet. The green LED on the keyboard lights up, indicating that power is connected. See Figure 18.

To Keep the Battery Charged

Leave the electrocardiograph connected to AC power whenever possible. Battery charge status is indicated on the screen by an icon: . When the charge gets low, the icon flashes. When the charge gets too low to operate, a warning message appears and the electrocardiograph beeps every 15 seconds for 1 minute, then it turns off.

For more, see “Recharging a Fully Discharged Battery” on page 76.

Figure 18. AC Power Inlet and Green LED

AC power inlet

On/Off key

Green LED

Page 27

Directions for Use Chapter 2 Setting Up the Electrocardiograph 23

To Turn the Electrocardiograph On

Press .

To Turn the Electrocardiograph Off

Press and hold.

Note

If Power-Save is enabled, the electrocardiograph turns off automatically after several idle minutes. To learn how to enable or disable Power-Save, see

“Reviewing the Device Configuration Settings” on page 27.

Verifying Proper Operation

Once your electrocardiograph is set up, verify proper operation by using an ECG simulator to acquire and print a standard 12-lead ECG of known amplitude. See Step 2 on page 75.

Note

As part of your initial set-up, you may want to adjust the display contrast. To learn how, see “Reviewing the Device Configuration Settings” on page 27.

You may also want to change other software settings, as described in the following chapters:

• “Reviewing the System Settings” on page 25

• “Reviewing the ECG Settings” on page 33

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24 Chapter 2 Setting Up the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Page 29

Reviewing the System Settings

“System Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Reviewing the Device Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Reviewing the Device Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Reviewing the Medication List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Reviewing the History List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

This chapter documents the system settings, which affect both ECG and spirometry functions. For information on the following related tasks, see the procedures identified here:

• Reviewing ECG settings

See “Reviewing the ECG Settings” on page 33.

• Reviewing spirometry settings

Spirometry manual.

• Printing all settings

See “Reviewing the Device Information” on page 29.

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26 Chapter 3 Reviewing the System Settings Welch Allyn CP 200 Electrocardiograph

“System Settings” Menu Tree

System Settings

Device

Configuration

Set Date/Time Language Date Format Time F ormat Weight Unit Height Unit Power-Save Device ID Audio Beeper Flow Unit Pressure Unit Temperature Increase Display Contrast Decrease Display Contrast

Applicable for spirometry only.

Device

Info

About Print Settings Enable Options Upgrade Software Service Info

Device

Administration

See “Managing Data

Security” on page 69.

Page 31

Directions for Use Chapter 3 Reviewing the System Settings 27

Reviewing the Device Configuration Settings

1. Press the Menu key .

2. Choose System Settings > Device Configuration.

The following screen appears.

Figure 19. “Device Configuration” Screen

Device Configuration

1 Set Date/Time 2 Language 3 Date Format 4 Time Format 5 Weight Unit 6 Height Unit 7 Power-Save 8 Device ID 9 Audio Beeper A Flow Unit

9:17AM Oct 16 05

3. Change any desired settings.

Setting Description

Set Date/Time Current date and time.

Language List of languages available. Changes take effect when the next screen appears.

Date Format MM/DD/YY (month/day/year)

Time Format 24-hour or AM/PM.

Weight Unit Kilograms (kg) or pounds (lb).

Height Unit Centimeters (cm), inches (in), or feet and inches (ft, in).

Power-Save On or off. When on, the electrocardiograph turns itself off after several idle minutes.

Device ID Electrocardiograph identification. Enter up to 20 characters.

Audio Beeper On or off. When on, beeps to indicate errors, such as incorrect input, improper external

Flow Unit L/sec or L/min. For spirometry only. Determines the y-axis units for flow/volume curves.

Pressure Unit mmHg, mbar, inHg, kPa. For spirometry only. Determines the units for the calibration

DD/MM/YY (day/month/year)

connections, or a printer error. Beeps may also indicate a low battery.

menu’s atmospheric pressure values.

Temperature Fahrenheit or Celsius. For spirometry only. Determines the units for the calibration

menu’s temperature values.

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28 Chapter 3 Reviewing the System Settings Welch Allyn CP 200 Electrocardiograph

Setting (Continued) Description (Continued)

Increase Display Contrast

Decrease Display Contrast

Each time you select this choice, the display contrast immediately increases until you reach maximum contrast.

Each time you select this choice, the display contrast immediately decreases until you reach minimum contrast.

Page 33

Directions for Use Chapter 3 Reviewing the System Settings 29

Reviewing the Device Information

1. Press the Menu key .

2. Choose System Settings > Device Info.

The following screen appears.

Figure 20. “Device Info” Screen

Device Info

1 About 2 Print Settings 3 Enable Options 4 Upgrade Software 5 Service Info 0 Previous Menu

9:17AM Oct 16 05

3. Select the desired item:

Item Description

About Displays the following information about the electrocardiograph:

• serial number

• modules configured

• version numbers

Print Settings Prints your ECG, spirometry, and system settings as well as medication & history

lists.

Enable Options Contact Technical Support. For phone numbers, see page ii.

Upgrade Software Contact Technical Support. For phone numbers, see page ii.

Service Info Accessible to service support only.

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30 Chapter 3 Reviewing the System Settings Welch Allyn CP 200 Electrocardiograph

Reviewing the Medication List

The medication list determines which medications are available to choose during patient data entry.

1. Press the Menu key .

2. Choose Edit Medication List.

The following screen appears.

Figure 21. “Edit Medication List” Screen

Edit Medication List

Medication Name

ACE Inhibitors Albuterol Alpha Blockers Amiodarone Beclomethasone Beta Blocker Bitolterol

Add Delete Exit

3. Press the desired softkeys:

•Add

Lets you add medications, up to a total of 40.

• Delete

Deletes the highlighted medication.

•Exit

Returns to the main menu.

9:17AM Oct 16 05

Page 35

Directions for Use Chapter 3 Reviewing the System Settings 31

Reviewing the History List

The history list determines which clinical conditions are available to choose during patient data entry.

1. Press the Menu key .

2. Choose Edit History List.

The following screen appears.

Figure 22. “Edit History List” Screen

Edit History List

History Name

Acute Bronchitis Acute Respiratory Failure Allergies/Sneezing Asphyxia Asthma Bronchiolitis Bronchitis

Add Delete Exit

3. Press the desired softkeys:

•Add

Lets you add conditions, up to a total of 40.

•Delete

Deletes the highlighted condition.

•Exit

Returns to the main menu.

9:17AM Oct 16 05

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32 Chapter 3 Reviewing the System Settings Welch Allyn CP 200 Electrocardiograph

Page 37

Reviewing the ECG Settings

“ECG Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Reviewing the Auto Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Reviewing the Rhythm Report Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Reviewing the Miscellaneous ECG Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

This chapter documents the ECG settings. For information on the following related tasks, see the procedures identified here:

• Reviewing system settings (which affect both ECG and spirometry functions)

See “Reviewing the System Settings” on page 25.

• Reviewing spirometry settings

Spirometry manual.

• Printing all settings

See “Reviewing the Device Information” on page 29.

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34 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 200 Electrocardiograph

“ECG Settings” Menu Tree

ECG Settings

Edit

Auto Report 1

Format

Lead Arrangement Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Extended Measurements Average Cycles

Interp Settings

Print Interpretation? Copies Copies With Interp Reason Statements Unconfirmed Report Abnormal ECG

Patient Data

Edit

Auto Report 2

Format

Lead Arrangement Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Extended Measurements Average Cycles

Interp Settings

Print Interpretation? Copies Copies With Interp Reason Statements Unconfirmed Report Abnormal ECG

Patient Data

Edit

Rhythm Report

Lead Arrangement

Miscellaneous

Lead Configuration Electrode Labels Baseline Centering Lead Timing Default Gain Setting Default Baseline Filter Default Muscle Filter Mains Filter Auto Save Auto Send Auto Report 2

First Name Middle Initial Age/Birth Date? Weight Height Gender Race Medication History Blood Pressure Comments Custom 1 Custom 1 Label Custom 2 Custom 2 Label

Page 39

Directions for Use Chapter 4 Reviewing the ECG Settings 35

Reviewing the Auto Report Settings

An Auto ECG is a report of ECG data in one of two user-defined formats: Auto Report 1 or Auto Report 2. For an example, see Figure 23. To learn how to set up or interpret a report, see the references on page 36.

Note

If you want a second predefined format to be available, enable Auto Report 2. To learn how, see “Reviewing the Miscellaneous ECG Settings” on page 43.

Figure 23. Auto Report Example — 3x4 +3R Lead Arrangement

A. Patient data B. ECG measurements C. Interpretation (optional)

D. Report status label

E. 3 rows, 4 columns

N. Calibration pulse

L. Gain

K. Frequency rangeM. Paper speed

J. AC filter

F. Rhythm leads

G. Software version

H. Device ID

I. Date and time

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36 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 200 Electrocardiograph

Item (in Figure 23 on page 35) Description

A. Patient data See “Reviewing the Patient Data Fields Available for Auto Reports” on page 40.

B. ECG measurements Standard.

C. Interpretation (optional) See “Reviewing the Interpretation and Copy Settings for Auto Reports” on

page 39.

D. Report status label See “Reviewing the Interpretation and Copy Settings for Auto Reports” on

page 39.

E. 3 rows, 4 columns See “Reviewing the Format Settings for Auto Reports” on page 37.

F. Rhythm leads See “Reviewing the Format Settings for Auto Reports” on page 37.

G. Software version See also “Reviewing the Device Information” on page 29.

H. Device ID See “Device ID” on page 27.

I. Date and time See “Set Date/Time” on page 27.

J. AC filter See “Mains Filter” on page 43.

K. Frequency range Lower limit: baseline filter on = 0.5, off = 0.3

L. Gain See “Gain” on page 61.

M. Paper speed See “Speed” on page 61.

N. Calibration pulse Amplitude reference — represents the current height of a one-millivolt signal.

Upper limit: muscle filter on = 35, off = 150 See “Baseline Filter” on page 61 and “Muscle Filter” on page 61.

Is adjusted for the selected gain:

5 mm/mV = 0.5 x 10 mm/mV = 1 x 20 mm/mV = 2 x

Page 41

Directions for Use Chapter 4 Reviewing the ECG Settings 37

Reviewing the Format Settings for Auto Reports

1. Press the Menu key .

2. Choose ECG Settings > Edit Auto Report 1 (or 2) > Format.

The following screen appears.

Figure 24. Auto Report “Format” Screen

Format

1 Lead Arrangement 2 Rhythm Lead 1 3 Rhythm Lead 2 4 Rhythm Lead 3 5 Extended Measurements 6 Average Cycles 0 Previous Menu

9:17AM Oct 16 05

3. Change any desired settings.

For a report example, see Figure 23 on page 35.

Setting Description

Lead Arrangement Arrangement of the leads on the report.

• 3x4 3 rows x 4 columns

• 3x4 +1R 3 rows x 4 columns + 1 rhythm lead

• 3x4 +3R 3 rows x 4 columns + 3 rhythm leads

• 6x2 6 rows x 2 columns

• 12x1 12 rows x 1 column

• 6x2 50 mm/s 6 rows x 2 columns, 50 mm/s

• 6x2 Ext. 6 rows x 2 columns, extended printouts

• No Print No report prints

(two pages, 20 seconds of ECG data)

Rhythm Lead 1 Rhythm lead to print at the bottom of 3x4 +1R and 3x4 +3R reports.

Rhythm Lead 2 Second rhythm lead to print at the bottom of 3x4 +3R reports.

Rhythm Lead 3 Third rhythm lead to print at the bottom of 3x4 +3R reports.

Extended Measurements

On or off. When on, an additional page prints with the report. Extended measurements include the values for several common parameters, such as Q, R, and S amplitude and ST values. The amplitudes are expressed in microvolts. The durations are expressed in milliseconds. The measurements cannot be edited.

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38 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 200 Electrocardiograph

Setting (Continued) Description (Continued)

Average Cycles If desired, an additional page prints with the report. Average cycles show the dominant

waveforms for all 12 leads.

• 3x4 50 mm/s + 3R 3 rows x 4 columns + 3 rhythm leads, 50 mm/s

• 6x2 50 mm/s + 6R 6 rows x 2 columns + 6 rhythm leads, 50 mm/s

• No Print Average cycles page does not print.

Page 43

Directions for Use Chapter 4 Reviewing the ECG Settings 39

Reviewing the Interpretation and Copy Settings for Auto Reports

1. Press the Menu key .

2. Choose ECG Settings > Edit Auto Report 1 (or 2) > Interp Settings.

The following screen appears.

Figure 25. “Interpretation Settings” Screen

Interp Settings

1 Print Interpretation? 2 Copies 3 Copies With Interp 4 Reason Statements 5 Unconfirmed Report 6 Abnormal ECG 0 Previous Menu

9:17AM Oct 16 05

3. Change any desired settings.

For a report example, see Figure 23 on page 35.

Setting Description

Print Interpretation? On or off. Determines whether interpretation is printed and saved with reports.

Copies Number of copies to print automatically in addition to the original report:

Copies With Interp On or off. Determines whether interpretation is printed on the automatic copies.

0, 1, 2, 3, 4, or 5.

Reason Statements On or off. Determines whether reasons (criteria) are printed with the interpretation

statements.

Unconfirmed Report On or off. Determines whether the label “Unconfirmed Report” is printed on reports.

Abnormal ECG On or off. Determines whether the label “Abnormal ECG” is printed on reports.

Available only for systems using automatic interpretation.

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40 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 200 Electrocardiograph

Reviewing the Patient Data Fields Available for Auto Reports

You can determine which fields appear during patient data entry for Auto ECGs.

Note

Spirometry tests use a separate set of data-entry fields, as described in the spirometry manual.

To Choose the Fields

1. Press the Menu key .

2. Choose ECG Settings > Edit Auto Report 1 (or 2) > Patient Data.

The following screen appears.

Figure 26. “Patient Data” Screen for ECGs

Patient Data

1 First Name 2 Middle Initial 3 Age/Birth Date? 4 Weight 5 Height 6 Gender 7 Race 8 Medication 9 History A Blood Pressure

9:17AM Oct 16 05

The Patient ID and Last Name fields always appear on the Enter New Patient screen, as shown in Figure 33 on page 50. Since these two fields cannot be disabled, they do not appear on this user-selectable list.

3. Change any desired settings.

Disabled items (set to off or no) neither display nor print.

Field Description

First Name Yes or no. If yes, this field is enabled.

Middle Initial Yes or no. If yes, this field is enabled.

Age/Birth Date? Birth Date, age, or off. Determines whether and how this data is labeled and entered.

Weight Yes or no. If yes, this field is enabled for entering patients’ weight. For instructions on

Height Yes or no. If yes, this field is enabled for entering patients’ height. For instructions on

Gender Yes or no. If yes, this field is enabled. Data-entry choices: Male, Female, or Unknown.

Race Yes or no. If yes, this field is enabled. Data-entry choices: Blank, Caucasian, Black,

For instructions on changing the date format (MM/DD/YY or DD/MM/YY), see

“Reviewing the Device Configuration Settings” on page 27.

changing the weight units (kg or lb), see “Reviewing the Device Configuration Settings” on page 27.

changing the height units (cm, in., or ft and in.), see “Reviewing the Device Configuration

Settings” on page 27.

Hispanic, Asian, Unknown.

Page 45

Directions for Use Chapter 4 Reviewing the ECG Settings 41

Field (Continued) Description (Continued)

Medication Yes or no. If yes, this field is enabled. During data entry, choose up to three items from

the list of patient medications. To learn how to edit this list, see “Reviewing the

Medication List” on page 30.

History Yes or no. If yes, this field is enabled. During data entry, choose up to three items from

the list of patient clinical conditions. To learn how to edit this list, see “Reviewing the

History List” on page 31.

Blood Pressure Yes or no. If yes, this field is enabled for entering blood pressure in standard ### / ###

format.

Comments Yes or no. If yes, this field is enabled for entering comments.

Custom 1 Yes or no. If yes, this field is enabled for entering data of your choice.

Custom 1 Label You may define a label for the Custom 1 field if desired.

Custom 2 Yes or no. If yes, this field is enabled for entering data of your choice.

Custom 2 Label You may define a label for the Custom 2 field if desired.

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42 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 200 Electrocardiograph

Reviewing the Rhythm Report Settings

Rhythm Reports can print either 3, 6, or all 12 leads at a time.

To Change the Number of Leads That Print

1. Press the Menu key .

2. Choose ECG Settings > Edit Rhythm Report > Lead Arrangement.

The following screen appears.

Figure 27. “Lead Arrangement” Submenu

Edit Rhythm Report

1 Lead Arrangement 0 Previous Menu

9:17AM Oct 16 05

3–Lead 6–Lead

12–Lead

3. Choose the number of leads you want to print at a time: 3, 6, or 12.

For instructions on cycling through 3-lead or 6-lead groupings while printing a rhythm report, see Step 1 on page 56.

Page 47

Directions for Use Chapter 4 Reviewing the ECG Settings 43

Reviewing the Miscellaneous ECG Settings

1. Press the Menu key .

2. Choose ECG Settings > Miscellaneous.

The following screen appears.

Figure 28. “Miscellaneous” Screen for ECG Settings

Miscellaneous

1 Lead Configuration 2 Electrode Labels 3 Baseline Centering 4 Lead Timing 5 Default Gain Setting 6 Default Baseline Filter 7 Default Muscle Filter 8 Mains Filter 9 Auto Save A Auto Send

9:17AM Oct 16 05

These three default settings—gain, baseline filter, and muscle filter—determine the values used every time you begin a new test, even if these values have been temporarily changed during ECG testing.

3. Change any desired settings.

Setting Description

Lead Configuration Standard (I II III, aVR aVL aVF, V1 V2 V3, V4 V5 V6) or

Electrode Labels AHA or IEC.

Baseline Centering On or off. When on, aligns the isolectric line of all leads.

Lead Timing Simultaneous or sequential. “Simultaneous” prints ECG data that was captured

Cabrera (aVL I –aVR, II aVF III, V1 V2 V3, V4 V5 V6).

simultaneously for all lead groups. “Sequential” prints ECG data that was captured at sequential intervals for each lead group in turn.

Default Gain Setting 5 mm/mV, 10 mm/mV, 20 mm/mV, or Auto. (AUTO is available for Auto ECGs only, not

rhythm ECGs. AUTO is usually the best setting, but some waveforms may be easier to read on other settings.) For details, see “Gain” on page 61.

Default Baseline Filter On or off. For details, see “Baseline Filter” on page 61.

Default Muscle Filter On or off. For details, see “Muscle Filter” on page 61.

Mains Filter Off, 50 Hz, 60 Hz. Use of this filter is recommended. For suggestions on eliminating AC

interference, see page 85.

Auto Save On or off. When on, the electrocardiograph automatically saves all ECGs (except stat

ECGs) to its test directory. When off, every time you print an ECG test you are asked if you want to save. For description of the test directory, see “Managing Saved Tests” on page 64.

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44 Chapter 4 Reviewing the ECG Settings Welch Allyn CP 200 Electrocardiograph

Setting (Continued) Description (Continued)

Auto Send Memory card, workstation, or off. Automatically sends all ECGs (except stat ECGs) to

the option of your choice.

If set to memory card, an SD memory card must be in place during testing. For slot location, see Figure 5 on page 7.

If set to workstation, a USB cable must connect a CardioPerfect workstation to the electrocardiograph’s Com port B ( ). For port location, see Figure 5 on page 7.

Auto Report 2 On or off. When on, a second predefined report format is available.

Page 49

Performing ECG Tests

Connecting the Leads to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Recording an Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Recording a Rhythm ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Searching for Saved Patient Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Adjusting the ECG Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

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46 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

Connecting the Leads to the Patient

1. Help the patient get comfortable. Patient preparation is important for a successful ECG.

a. Describe the procedure. If desired, press the Help key and print the page

entitled “What Is An ECG?” for the patient to read.

b. Help the patient get warm and relaxed. Excessive patient movement could

interfere with the operation of the electrocardiograph.

c. Put the patient in a reclining position with the head slightly higher than the heart

and legs.

WARNING ECG electrodes could cause skin irritation. Examine the skin for signs of irritation or inflammation.

2. Prepare electrode locations. See Figure 29 on page 47.

a. Shave if necessary.

b. Clean with alcohol or acetone.

c. Allow to dry.

3. Attach the electrodes and lead wires securely.

• For reusable electrodes:

Straps must neither slide nor be so tight as to cause discomfort.

The electrode paste, gel, or creme must cover an area the size of the electrode but no larger, especially on the chest.

• For disposable tab electrodes:

Place the electrode tab between the “jaws” of the electrode adapter, keeping the tab flat.

Gently tug on the adapter to ensure that it is properly placed on the electrode. (Each time you remove and reattach an electrode, the conductive gel becomes weaker and less effective.)

Page 51

Directions for Use Chapter 5 Performing ECG Tests 47

Figure 29. Electrode Placement Locations

Electrodes

AHA IEC Locations

AV1

red

BV2

yellow

CV3

green

DV4

blue

EV5

orange

FV6

purple

GRA

white

HLA

black

IRL

green

JLL

red

yellow

green

brown

black

purple

red

yellow

black

green

Fourth intercostal space at right sternal border.

Fourth intercostal space at left sternal border.

Midway between V2 and V4.

Fifth intercostal space at left of midclavicular line.

Anterior axillary line at same horizontal level as V4.

Mid-axillary line on same horizontal level as V4 and V5.

Just above right wrist on inside of arm.

Just above left wrist on inside of arm.

Just above right ankle.

Just above left ankle.

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48 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

4. If the electrocardiograph’s display is blank, press .

5. If the Lead Off screen appears, as shown here, reattach any leads that are flashing.

Figure 30. “Lead Off” Screen

9:17AM Oct 16 05

Lead off

Check lead

V1 V2

The most common ECG problems are poor electrode contact and loose leads.

When all leads have been connected for three seconds, the following screen appears.

Figure 31. “ECG Preview” Screen

ECG Preview

III

AUTO 25 mm/s

Gain

OFF

Baseline

Filter

9:17AM Oct 16 05

OFF

Muscle

Filter

Spee dLeads

6. (Optional) Use the softkeys as desired.

For details, see “Adjusting the ECG Waveforms” on page 61.

7. Go to the procedure for the type of ECG test you want to perform.

• “Recording an Auto ECG” on page 49

• “Recording a Rhythm ECG” on page 56

Page 53

Directions for Use Chapter 5 Performing ECG Tests 49

Recording an Auto ECG

An Auto ECG is a report typically showing a 10-second acquisition of 12 leads of ECG information combined with patient data, interpretation, and measurements matrix. Two user-defined formats are available: Auto Report 1 or Auto Report 2. To learn how to set up the Auto ECG report format, see “Reviewing the Auto Report Settings” on page 35.

As shown in the following diagram, there are the two types of Auto ECG: normal and stat. For details, see these procedures:

• “Recording a Normal Auto ECG” on page 50

• “Recording a Stat Auto ECG” on page 55

Figure 32. Auto ECG Testing, Process Diagram

Normal

Press quickly.

(Optional)

Select report

format.

Enter, repeat, or

search for patient

data.

(Optional)

Adjust

waveforms.

Press

Print ECG.

Stat

Press and hold.

Auto Report prints.

Auto ECG Post-Print

screen.

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50 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

Recording a Normal Auto ECG

For a normal Auto ECG, you enter patient data and do other optional tasks before printing, as shown in Figure 32 on page 49.

To Record a Normal Auto ECG

1. Pr es s t he Auto ECG key quickly.

Do not hold it down, or a stat ECG would begin.

2. If prompted, choose Auto Report 1 or Auto Report 2.

3. If asked “Repeat same patient?,” press the desired softkey.

• Ye s — to perform another ECG for the same patient.

The Auto ECG Acquisition screen appears. Go to Step 5 on page 51.

• No — to clear the current patient data.

The following screen appears.

Figure 33. “Enter New Patient” Screen

Enter New Patient

Patient ID Last Name First Name Birth Date Weight Height Gender

Search Schedule

lb.

ft. in.

Clear

9:17AM Oct 16 05

MM / DD / YYYY

Done

For details about these data fields— including how to choose which fields display and print—see “Reviewing the

Patient Data Fields Available for Auto Reports” on page 40.

4. Enter or search for the patient data.

• If you want to find a patient whose data has already been entered, go to

“Searching for Saved Patient Data” on page 57.

• If you want to enter the data, fill in the fields.

When finished, press the desired softkey:

Clear deletes the entered data and returns to the Patient ID field.

Done accepts the entered data and goes to the Auto ECG Acquisition

screen. See Figure 34 on page 51.

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Directions for Use Chapter 5 Performing ECG Tests 51

Figure 34. “Auto ECG Acquisition” Screen

Doe, Jane

Auto ECG Acquisition

aVR

AUTO ONON

Leads

Gain

Baseline

Filter

9:17AM Oct 16 05

Muscle

Filter

Print ECG

5. Verify ECG quality on the screen.

WARNING Do not perform ST segment analysis on the ECG screen display, since these ECG representations are scaled. Make manual measurements of ECG intervals and magnitudes on printed ECG reports only.

6. (Optional) Adjust the waveforms.

See “Adjusting the ECG Waveforms” on page 61.

7. P r e s s Print ECG.

Softkeys for adjusting the waveforms or printing

8. If prompted, choose whether to wait for the electrocardiograph to acquire 10 seconds of filtered, processed data before printing.

If you override the wait time and print the available data immediately, be aware that the printed data will be insufficient in quality or quantity or both.

The report prints.

Note

If a red stripe appears along the edge of your report, replace the paper. See “Loading the Thermal Chart Paper” on page 21.

After printing, the Auto ECG Post-Print screen appears. Figure 35 on page 52.

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52 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

Figure 35. “Auto ECG Post-Print” Screen

Doe, Jane

Auto ECG Post-Print

aVR

9:17AM Oct 16 05

Softkeys for choosing

Copy

Edit Te st

Manual

Save

Manual

Send

Exit

post-printing options

9. (Optional) If you want to repeat the test, go back to Step 1 on page 50.

10. Press the desired softkey.

Softkey Effect

Print Copy Prints a copy of the test.

To learn how to print multiple copies of all tests automatically, see “Reviewing the

Interpretation and Copy Settings for Auto Reports” on page 39.

Edit Test Brings up the Edit Test – Patient Data screen. From here you can edit or confirm the

patient data and interpretation statements. See “To Edit or Confirm a Test Directly

After Printing” on page 54.

Manual Save Saves the test to the electrocardiograph’s test directory. See “Managing Saved

Tests” on page 64.

This Manual Save softkey appears only when Auto Save is disabled. For more on Auto Save, see “Reviewing the Miscellaneous ECG Settings” on page 43.

Manual Send Displays two softkey options:

• Memory Card

An SD memory card must be in place. For slot location, see Figure 5 on page 7.

• Workstation

A USB cable must connect the CardioPerfect workstation to the electrocardiograph’s Com port B ( ). For port location, see Figure 5 on page 7.

This Manual Send softkey appears only when Auto Send is disabled. For more on Auto Send, see “Reviewing the Miscellaneous ECG Settings” on page 43.

Exit The ECG Preview screen appears if all leads are connected to the patient.

Page 57

Directions for Use Chapter 5 Performing ECG Tests 53

Caution The requirements of AAMI EC11, Section 3.2.7.2, Frequency and Impulse Response, for an impulse triangle waveform may be impacted by up to 5 milliseconds of small amplitude dampened ringing immediately after the impulse when the muscle filter (35 Hz) is turned on or a small amplitude offset when the baseline filter (0.5 Hz) is turned on. These requirements are unaffected by any other combination of filters turned on or off. Measurements performed by the optional interpretation algorithm are unaffected by any filter selections.

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54 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

To Edit or Confirm a Test Directly After Printing

Note

A qualified physician must review and confirm all tests before patients are treated. If changes are needed for any saved test, you can edit two types of data:

• patient data

• interpretation statements

1. From the Auto ECG Post-Print screen (Figure 35 on page 52), press Edit Test.

The Edit Test – Patient Data screen appears.

2. (Optional) Edit the patient data.

3. Press the desired softkey.

Softkey Effect

Interp Saves any changes, and displays the Edit Test – Interpretation screen.

1. (Optional) Edit the interpretation statements to be saved with the test.

2. Press the desired softkey:

• Patient Data saves any changes, and returns to the Edit Test – Patient Data

screen.

• Confirm saves any changes, sets the test status to “confirmed,” and returns to the Auto ECG Post-Print screen.

• Cancel discards any changes, and returns to the Auto ECG Post-Print screen.

• Done saves any changes, and returns to the Auto ECG Post-Print screen.

For details on interpretation, see “Automatic ECG interpretation” on page 4.

Cancel Discards any changes, and returns to the Auto ECG Post-Print screen.

Done Saves any changes, and returns to the Auto ECG Post-Print screen.

Page 59

Directions for Use Chapter 5 Performing ECG Tests 55

Recording a Stat Auto ECG

A stat Auto ECG is an immediate printout in Auto Report 1 format.

Stat mode bypasses patient data entry, as shown in Figure 32 on page 49. A temporary ID number is assigned to the patient to identify stat tests. After printing, you may enter the patient data by editing the test.

In stat mode, Auto Send and Auto Save are always disabled, even if they are enabled in the ECG settings. If you want to send or save a stat Auto ECG, you may do so manually after you print.

To Record a Stat Auto ECG

1. Press and hold

The electrocardiograph begins acquiring ECG data. After it has acquired 10 seconds of quality data, it prints a report.

2. Go to Step 8 on page 51.

Continue the procedure as if you have just pressed the Print ECG softkey.

the Auto ECG key .

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56 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

Recording a Rhythm ECG

A Rhythm ECG is a continuous, real-time printout of a rhythm strip with a user-defined lead arrangement. For details on reviewing or changing the lead arrangement in your reports, see “Reviewing the Rhythm Report Settings” on page 42.

Rhythm ECGs are printouts only. They cannot be saved or sent electronically.

Figure 36. Rhythm ECG Testing, Process Diagram

Printing begins.

(Optional) Adjust

waveforms.

To Record a Rhythm ECG

1. Pr es s t he Rhythm ECG key .

Printing begins.

The screen displays 3 leads at a time from the leads currently printing. The printout includes either 3, 6, or 12 leads at a time. To find out how to change this number, see

“Reviewing the Rhythm Report Settings” on page 42.

Figure 37. “Rhythm ECG” Screen

Doe, Jane

Rhythm ECG

aVR

10 mm/mV

Gain

Baseline

Filter

9:17AM Oct 16 05

25 mm/sONON

Muscle

Filter

SpeedLeads

Softkeys for adjusting waveforms while printing

1. (Optional) Press the softkeys to adjust the waveforms.

See “Adjusting the ECG Waveforms” on page 61.

2. Press or to stop printing.

The ECG Preview screen appears if all leads are connected to the patient.

(Optional) Adjust the waveforms.

Page 61

Directions for Use Chapter 5 Performing ECG Tests 57

Searching for Saved Patient Data

During an ECG or spirometry test, instead of entering patient data manually you can search for patient data that has been saved in either of two places:

• In the scheduled patients list

The scheduled patients list identifies up to 40 patients whose data has been entered into the electrocardiograph’s memory for an ECG or spirometry test that day. For more, see “Managing the Scheduled Patients List” on page 68.

• In the test directory

The test directory is the collection of tests saved in the electrocardiograph’s memory. This directory holds up to 50 ECG and 50 spirometry tests. For more, see “Managing

Saved Tests” on page 64.

The following diagram illustrates the procedure for both types of searching. For step-bystep instructions, see these sections:

• “To Search the Test Directory” on page 58

• “To Search the Scheduled Patients List” on page 60

Figure 38. Patient Search, Process Diagram

Go to

Enter New Patient

screen.

Go to

Search for Patient

screen.*

* Password is required if user login is enabled.

Enter patient’s

last name or ID.

Choose a patient from the

test directory.

Scheduled Patients List

Go to

screen.*

Choose a patient from the

scheduled patients list.

Continue ECG or

spirometry test.

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58 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

To Search the Test Directory

1. From the Enter New Patient screen (Figure 33 on page 50), press Search.

If prompted to log in, enter your user ID and password.

The following screen appears.

Figure 39. “Search for Patient” Screen

Search for Patient

Patient ID:

Last Name:

9:17AM Oct 16 05

Brings up any matching names in the test directory.

New

Patient

Schedule

2. Enter the patient’s complete identification number or last name (partial or complete).

3. Press Search.

If one or more patients match your entry, their names appear.

Note The other two softkeys exit this search:

• New Patient returns to the Enter New Patient screen. See Figure 33 on

page 50.

• Schedule brings up the Scheduled Patients List screen. Go to “To

Search the Scheduled Patients List” on page 60.

Page 63

Directions for Use Chapter 5 Performing ECG Tests 59

Figure 40. “Patient Search Results” Screen

Patient Search Results

Patient ID

Back

9:17AM Oct 16 05

Patient Name

Select

4. Take the desired action.

• Press Back.

The Search for Patient screen reappears.

• Highlight a patient name, and press Select.

The next screen in your procedure appears. (For ECG tests, go to Step 5 on page 51. For spirometry tests, see the spirometry manual.)

Your search results (matching names from test directory).

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60 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

To Search the Scheduled Patients List

1. From the Enter New Patient screen (Figure 33 on page 50), press Schedule.

If prompted to log in, enter your user ID and password.

The following screen appears.

Figure 41. “Scheduled Patient List” Screen (for Searching)

Scheduled Patient List

Patient ID

9:17AM Oct 16 05

Patient Name

Today’s scheduled patients.

New

Patient

Select

2. Highlight the desired name. Press Select.

The next screen in your procedure appears. (For ECG tests, go to Step 5 on page 51. For spirometry tests, see the spirometry manual.)

Note

The other two softkeys exit this search:

• New Patient returns to the Enter New Patient screen. See Figure 33 on

page 50.

• Search brings up the Search for Patient screen. Go to “To Search the

Test Directory” on page 58.

Page 65

Directions for Use Chapter 5 Performing ECG Tests 61

Adjusting the ECG Waveforms

The following softkeys appear on the Auto ECG Acquisition and Rhythm ECG screens (Figure 34 on page 51 and Figure 37 on page 56). Use these softkeys before printing an Auto ECG or while printing a rhythm ECG.

Softkey Effect

Leads Cycles through the leads in groups of three on the screen. For rhythm reports, also cycles through the lead groups that are

printing (if <12). To learn how to change the number of leads per group—3, 6, or 12—on rhythm reports, see “Reviewing

the Rhythm Report Settings” on page 42. To learn how to change between standard and Cabrera lead groupings, see “Reviewing the Miscellaneous ECG Settings” on page 43.

Gain Cycles through the gain settings in mm/mV (5, 10, 20, AUTO), zooming in and out. (AUTO is available for Auto ECGs only,

not rhythm ECGs. AUTO is usually the best setting, but some waveforms may be easier to read on other settings.) To learn how to change the the gain’s default setting, see “Reviewing the Miscellaneous ECG Settings” on page 43.

5 mm/mV 20 mm/mV

Baseline Filter Toggles between the two baseline filter settings (on or off). This filter reduces “wandering baseline,” an upward and

downward fluctuation of the waveforms. It is preferable, if possible, to eliminate or reduce wandering baseline by addressing the causes, as explained on page 84. To learn how to change the the filter’s default setting, see “Reviewing

the Miscellaneous ECG Settings” on page 43. Caution: You cannot perform ST segment analysis on waveforms that were

recorded with the baseline filter turned on. For details, see the caution on page 53.

Muscle Filter Toggles between the two muscle filter settings (on or off). This filter reduces muscle tremor interference: random,

Speed (available for Rhythm ECGs only)

irregular voltage superimposed on the waveforms. It is preferable, if possible, to eliminate or reduce muscle tremor by addressing the causes, as explained on page 84. To learn how to change the the filter’s default setting, see “Reviewing

the Miscellaneous ECG Settings” on page 43. Caution: You cannot perform ST segment analysis on waveforms that were

recorded with the muscle filter turned on. For details, see the caution on page 53.

Cycles through the paper speed settings in mm/sec (10, 25, 50).

10 mm/mV

Wandering baseline

Muscle tremor interference

25 mm/sec 10 mm/sec

50 mm/sec

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62 Chapter 5 Performing ECG Tests Welch Allyn CP 200 Electrocardiograph

Page 67

Performing Administrative Tasks

Managing Saved Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Managing the Scheduled Patients List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Managing Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

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64 Chapter 6 Performing Administrative Tasks Welch Allyn CP 200 Electrocardiograph

Managing Saved Tests

The test directory is the collection of tests saved in the electrocardiograph’s memory. This directory holds up to 50 ECG and 50 spirometry tests. When the directory gets full, the electrocardiograph prompts you to delete the oldest tests before saving new ones.

When performing Auto ECG or spirometry tests, you may select patients from this directory rather than manually entering their data at the time of the test.

This section explains how to manage—view, edit, print, and send—saved tests. These tasks are all accomplished through the Test Directory menu, as illustrated here.

Figure 42. ”Test Directory” Menu Tree

Print Directory

Edit

Patient Data

Interpretation

Test Directory*

Search Results

Auto Report 1 Auto Report 2

* Password is required if user login is enabled.

Send

Memory Card Workstation

Page 69

Directions for Use Chapter 6 Performing Administrative Tasks 65

To View, Print, or Send Saved Tests

1. Press the Menu key .

2. Choose Test Directory.

If prompted to log in, enter your user ID and password.

The following screen appears.

Figure 43. Test Directory “Search” Screen

9:17AM Oct 16 05

Unprinted Tests Unconfirmed Tests Unsent Tests All Tests Date From Date To Patient ID Last Name

Managing the Scheduled Patients List

The scheduled patients list identifies up to 40 patients whose data has been entered into the electrocardiograph’s memory for an ECG or spirometry test that day. At midnight every night, the list is automatically cleared.

When performing Auto ECG or spirometry tests, you may select patients from this list rather than manually entering their data at the time of the test.

To View or Edit the Scheduled Patients List

1. Press the Menu key .

2. Choose Scheduled Patients.

If prompted to log in, enter your user ID and password.

The scheduled patients list appears.

Figure 44. “Scheduled Patients” Screen (for Editing)

Scheduled Patients

Patient ID

Patient Name

Add

3. Press the desired softkeys:

•Add

Brings up the Enter New Patient screen, shown in Figure 33 on page 50. Enter the patient’s data as described on that page.

• Delete

Deletes the highlighted patient name.

•Exit

Returns to the main menu.

9:17AM Oct 16 05

Delete

Today’s scheduled patients.

Exit

Page 73

Directions for Use Chapter 6 Performing Administrative Tasks 69

Managing Data Security

The CP 200 electrocardiograph incorporates security features that can keep patient data private and confidential. To implement your data security plan, use the Device Administration menu, which is illustrated here and described in the following pages.

Figure 45. “Device Administration” Menu Tree

System Settings

User Login

(Enable/Disable)

Edit User List

Device

Administration*

* Administrative-level password is required if user login is enabled.

Audit Trail

(Enable/Disable)

Print Audit Trail

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70 Chapter 6 Performing Administrative Tasks Welch Allyn CP 200 Electrocardiograph

Working With the User List and User Login

The user list identifies all individuals who are authorized to access patient data.

The user list can hold up to 25 users. After the list reaches 25 users, you can add names only if some names are set to inactive status. New names replace inactive names. If all 25 names are active, you receive a message that the user list is full.

Two levels of access can be assigned:

•User level

When the user login feature is enabled, all users on the user list have access to the test directory and the scheduled patient list, including searching and editing privileges.

• Administrator level

When the user login feature is enabled, only administrator-level users have access to the administrative functions. For an outline of these functions, see menu tree in

Figure 45 on page 69.

To Enable or Disable User Login

1. Press the Menu key .

2. Choose System Settings > Device Administration.

If prompted to log in, enter an administrator-level user ID and password.

3. Choose User Login.

4. Follow the prompts to enable or disable user login.

To Change a Password

You can change a password in either of two ways:

• At any User Login screen, press Change Password.

Follow the prompts.

• Ask an administrator-level user to change the password.

See “To Review or Edit the User List” on page 71.

Page 75

Directions for Use Chapter 6 Performing Administrative Tasks 71

To Review or Edit the User List

1. Press the Menu key .

2. Choose System Settings > Device Administration.

If prompted to log in, enter an administrator-level user ID and password.

Note

If no administrator-level password has been assigned, the system’s default user ID and password — available from Welch Allyn — works here. These defaults exist solely to provide access to the user list in the event that user login is enabled before an administrator is assigned.

3. Choose User List.

The user list appears.

4. Press the desired softkeys.

Softkey Effect

Add Lets you add new users. For each user, provide the following information:

• User ID (1 to 10 characters)

• Password (5 to 10 characters, displayed as asterisks for security)

• Password Expiration

- Never

- 180 days

•User’s Name

• User Level

- User

- Administrator

• Active?

- Yes (user cannot be replaced)

- No (user can be replaced when list is full)

Edit Lets you edit the information for the highlighted user.

Exit Returns to the Device Administration screen.

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72 Chapter 6 Performing Administrative Tasks Welch Allyn CP 200 Electrocardiograph

Working With the Audit Trail

An audit trail, a collection of information about user activity, may be helpful or even required for record-keeping. It tracks who did what when, including these types of activity:

• Accessing the test directory

• Searching the scheduled patient list

• Editing patient data

• Accessing administrative functions

When the audit trail is enabled, the electrocardiograph collects this type of information in a file in its memory. When the allotted memory begins to get full, you receive prompts to print the audit trail. You must print the audit trail to delete (purge) this information and make room for new information to be collected.

To Enable or Disable the Audit Trail

1. Press the Menu key .

2. Choose System Settings > Device Administration.

If prompted to log in, enter an administrator-level user ID and password.

3. Choose Audit Trail.

4. Follow the prompts to enable or disable the audit trail.

To Pr i n t a n Au d it Tra i l

1. Press the Menu key .

2. Choose System Settings > Device Administration.

If prompted to log in, enter an administrator-level user ID and password.

3. Choose Print Audit Trail.

4. Follow the prompts.

After you verify that printing was successful, the audit information is deleted.

Page 77

Maintaining the Electrocardiograph

Inspecting the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Cleaning the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Testing the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Recharging a Fully Discharged Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Replacing the Battery (DC) Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Replacing the AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Storing the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Discarding the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

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74 Chapter 7 Maintaining the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Inspecting the Equipment

WARNING To ensure patient safety and proper operation, perform the following inspections daily.

• Verify that patient leads are fully inserted. For details, see “Connecting the Patient

Cable” on page 20.

• Check for cracked or broken patient cable, patient leads, power cord, communications cables, display, and enclosure.

• Check for bent or missing pins on all cables.

• Check all cable and cord connections; reseat if any connectors are loose.

Cleaning the Equipment

WARNING To prevent the spread of infection, the electrocardiograph and patient cable must be kept clean, especially the components that come in contact with patients.

Caution Do not let soap or water come into contact with the electrocardiograph’s internal printer, connectors, or jacks.

Do not attempt to clean the electrocardiograph or the patient cable by submersing them in liquid, autoclaving, or steam cleaning. Do not pour alcohol directly on the equipment or soak any components in alcohol. If alcohol or liquids spill into the electrocardiograph while cleaning, arrange to have it checked before using it again. For Welch Allyn phone numbers, see page ii.

Monthly, or more often if needed, follow these cleaning instructions:

1. Disconnect the power plug from the AC outlet.

2. Wipe the exterior of the patient cable and electrocardiograph and with a damp cloth using mild detergent diluted in water.

3. Use 70% isopropyl alcohol to disinfect patient cable, lead wires, and equipment.

4. Dry all components with a clean, soft cloth or paper towel.

5. Wait at least 10 minutes to allow all traces of alcohol to evaporate before turning the electrocardiograph back on.

Page 79

Directions for Use Chapter 7 Maintaining the Electrocardiograph 75

Testing the Equipment

WARNING Only qualified service personnel should perform leakage current tests.

Whenever the electrocardiograph is serviced or problems are suspected, Welch Allyn recommends the following test procedures:

1. Verify continued electrical safety of the device, using IEC 60601-1 or ANSI/AAMI ES1 methods and limits. Test for the following:

• Patient leakage current

• Chassis leakage current

• Earth leakage current

• Dielectric strength (AC and patient circuits)

2. Verify that the electrocardiograph is working properly, using an ECG simulator to acquire and print a standard 12-lead ECG of known amplitude.

• Printing should be dark and even across the page.

• There should be no evidence of print-head dot failure (no printing breaks forming

horizontal streaks).

• Paper should move smoothly and consistently during printing.

• Waveforms should appear normal, with proper amplitude, and without distortion

or excessive noise.

• Paper should stop with perforations near the tear bar, indicating proper cue-

sensor operation. For tear-bar location, see Figure 17 on page 21.

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76 Chapter 7 Maintaining the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Recharging a Fully Discharged Battery

If the electrocardiograph does not turn on when unplugged, the battery may be fully discharged.

Note

To Recharge the Battery

1. Plug the electrocardiograph into AC power.

2. Verify that the green LED on the keyboard lights up. (See Figure 18 on page 22.)

3. Keep the electrocardiograph plugged in for 12 hours.

The first time you turn the electrocardiograph on after a full battery discharge, you are prompted to reenter the date and time.

If the electrocardiograph still does not turn on when it is unplugged from AC power, you may need to replace the battery or battery fuse. See “Replacing the Battery” on page 77 or “Replacing the Battery (DC) Fuse” on page 79.

Regardless of the battery condition, you can use the electrocardiograph whenever it is plugged in.

If the LED does not light up, go to “Replacing the AC Fuses” on page 80.

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Directions for Use Chapter 7 Maintaining the Electrocardiograph 77

Replacing the Battery

If you have recharged the battery and the electrocardiograph still does not turn on when unplugged, or if the battery loses its charge quickly, replace the battery as follows. (For part number, see “Accessories” on page 5.)

1. Unplug the electrocardiograph from AC power if connected.

2. Turn the electrocardiograph upside-down.

3. Unscrew and remove the battery door. See Figure 46.

4. Lift out the battery. See Figure 47.

Figure 46. Removing the Battery Door Figure 47. Lifting Out the Battery

5. Inspect the fuse. See Figure 48.

• If the “Z” wire is intact, go to Step 6.

• If the “Z” wire is broken or dark, replace the fuse. See “Replacing the Battery

(DC) Fuse” on page 79.

Figure 48. Battery Fuse Plugged In

“Z” wire

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78 Chapter 7 Maintaining the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

6. Unplug the two battery connectors. See Figure 49.

You may need to pull hard. Use pliers gently if necessary.

Figure 49. Battery Connectors

7. Connect a new battery by matching connector sizes. Do not force connectors to mismatch.

8. Carefully tuck in all cables. Place the battery into the battery compartment. Fold the strap so that it will not stick out when you replace the battery door. See Figure 50.

Figure 50. Folding the Battery Strap

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Directions for Use Chapter 7 Maintaining the Electrocardiograph 79

9. Replace the battery door and screws. Turn the electrocardiograph rightside-up.

It turns on automatically and displays a prompt to enter date and time.

10. Enter the date and time.

The electrocardiograph is ready to use.

11. Discard the old battery appropriately.

• In the USA, call 1-800-SAV-LEAD for instructions on how to recycle it.

• International users, contact your local authorities concerning recycling.

Replacing the Battery (DC) Fuse

If the battery (DC) fuse requires replacing, as described in Step 5 on page 77, follow these steps. For the fuse value, see “Fuses” on page 89.

1. Remove and discard the fuse. See Figure 51.

You may need to pull hard. Use pliers gently if necessary.

2. Connect a new fuse. It goes in either way.

3. Go to Step 8 on page 78.

Figure 51. Battery Fuse Removed

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80 Chapter 7 Maintaining the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Replacing the AC Fuses

If the green LED on the keyboard does not light up when the electrocardiograph is connected to AC power, you may need to replace one or both of the AC fuses, as follows. For the fuse value, see “Fuses” on page 89.

1. Unplug the electrocardiograph from AC power if connected.

WARNING Failure to unplug could result in electrocution.

2. Use needle-nosed pliers to remove the fuse case. See Figure 52.

3. Inspect the fuses. If either fuse is dark or has a broken wire, replace the fuse. See Figure 53.

4. Insert the fuse case. Line it up with the opening; it goes in only one way.

Figure 52. Removing AC Fuse Case Figure 53. AC Fuses Removed

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Directions for Use Chapter 7 Maintaining the Electrocardiograph 81

Storing the Equipment

When storing the electrocardiograph, cords, and accessories, observe the environmental storage conditions. See “Specifications” on page 89.

Discarding the Equipment

Discard the old battery appropriately.

• In the USA, call 1-800-SAV-LEAD for instructions on recycling it.

• International users, contact your local authorities concerning recycling.

Discard the electrocardiograph, cords, and accessories according to local laws.

Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at +44 207 365 6780.

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82 Chapter 7 Maintaining the Electrocardiograph Welch Allyn CP 200 Electrocardiograph

Page 87

Troubleshooting

Problem-Solving Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Service Policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

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84 Chapter 8 Troubleshooting Welch Allyn CP 200 Electrocardiograph

Problem-Solving Suggestions

This section includes several tables:

• Lead quality problems (Ta bl e 2 on page 84)

• System failure problems (Tabl e 3 on page 85)

• System messages (Tab le 4 on page 86)

If you try these suggestions and still have problems, contact Technical Support. For phone numbers, see page ii.

Table 2. Lead Quality Problems

Condition Causes Actions

A red dot is flashing on the Lead Off screen.

Lead-off information is displayed on the screen.

One or more leads prints as a square wave:

Wandering baseline (an upward and downward fluctuation of the waveforms):

Muscle tremor interference (random, irregular voltage superimposed on the waveforms). May resemble or coincide with AC interference:

• Electrode contact may be poor.

• A lead may be loose.

Note: Square waves may indicate that the electrocardiograph is inoperative, but they are more likely to indicate loose leads.

• Electrodes that are dirty, corroded, loose, or positioned on a bony area.

• Insufficient or dried electrode gel.

• Oily skin or body lotions.

• Rising and falling of chest during rapid or apprehensive breathing.

• Patient is uncomfortable, tense, nervous.

• Patient is cold and shivering.

• Exam bed is too narrow or short to comfortably support arms and legs.

• Arm or leg electrode straps are too tight.

• Reattach the lead.

• Replace the electrode.

• Verify that the electrode area has been properly prepared: shaved, cleaned with alcohol or acetone, allowed to dry.

• Verify that electrodes have been properly stored and handled.

• Clean skin with alcohol or acetone.

• Reposition or replace electrodes.

• Help patient relax.

• If wandering baseline persists, turn the baseline filter on. See “Baseline Filter” on page 61.

• Help patient get comfortable.

• Check all electrode contacts.

• If interference persists, turn the muscle-tremor filter on. See “Muscle Filter” on page 61.

• If interference still persists, the problem is probably electrical in nature. See the following suggestions for reducing AC interference.

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Directions for Use Chapter 8 Troubleshooting 85

Table 2. Lead Quality Problems (Continued)

Condition Causes Actions

AC interference (even-peaked, regular voltage superimposed on the waveforms). May resemble or coincide with muscletremor interference.

• Electrodes that are dirty, corroded, loose, or positioned on a bony area.

• Insufficient or dried electrode gel.

• Patient or technician touching an electrode during recording.

• Patient touching any metal parts of an exam table or bed.

• Broken lead wire, patient cable, or power cord.

• Electrical devices in the immediate area, lighting, concealed wiring in walls or floors.

• Improperly grounded electrical outlet.

• Incorrect AC filter frequency setting or AC filter is turned off.

• Check all electrode contacts and lead wires.

• Verify that the patient is not touching any metal.

• Verify that the AC power cable is not touching

• Verify that the proper AC filter is selected. See

• If interference persists, unplug the

• If interference still persists, the noise may be

Table 3. System Failure Problems

Condition Causes Actions

Won't turn on when plugged into AC power.

Won't turn on when unplugged from AC power.

• Faulty AC power connection.

• Blown AC fuses.

•No AC power.

• Battery disconnected or incorrectly connected.

• Battery low, not charging, depleted, or bad.

• Blown battery fuse.

• Check the AC power source.

• Check the AC fuses. See “Replacing the AC

• Check battery connections. See “Replacing the

• Recharge the battery. See “Recharging a Fully

• Replace battery. See “Replacing the Battery” on

• Replace battery fuse. See “Replacing the Battery

the patient lead cable.

“Mains Filter” on page 43.

electrocardiograph from AC power and run it on the battery. If this solves the problem, you’ll know that the noise was introduced through the power line.

caused by other equipment in the room or by poorly grounded power lines. Try moving to another room.

Fuses” on page 80.

Battery” on page 77.

Discharged Battery” on page 76.

page 77.

(DC) Fuse” on page 79.

Shuts down during printing Battery low or bad. • Recharge the battery. See “Recharging a Fully

Prints fewer than 10 reports on a full battery charge.

Degraded battery. Replace battery. See “Replacing the Battery” on

Discharged Battery” on page 76.

• Replace battery. See “Replacing the Battery” on page 77.

page 77.

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86 Chapter 8 Troubleshooting Welch Allyn CP 200 Electrocardiograph

Table 4. System Messages (alphabetical order)

System Message Problems Actions

“A test is being printed that has not been saved and will be lost. Continue shutdown?”

“Audit Trail is too large. Please print and purge.“

“Insufficient battery power to begin. Please connect AC power and try again.”

“Insufficient space available” Not enough space on memory card. • Delete some tests from the card at a PC.

“Memory card error” Problem writing to memory card. • Verify that the write-protect tab is in the

“Out Of Paper” • Printer is out of paper.

“Paper Error” Paper was loaded incorrectly. Reload the paper. See “Loading the Thermal Chart

“Powering down” Low battery. Recharge the battery. See “Recharging a Fully

was pressed while printing an

Auto ECG.

Audit information is approaching its maximum allotted storage.

Battery low or bad. • Recharge the battery. See “Recharging a Fully

• Printer door is open.

To shut down without saving the test, press .

To cancel the shutdown, press .

Print and purge the audit trail. See “Working With

the Audit Trail” on page 72.

Discharged Battery” on page 76.

• Replace battery. See “Replacing the Battery” on page 77.

• Use a different card.

unprotected position.

• Reseat the card in its slot.

• Use a different card.

• Load paper. See “Loading the Thermal Chart

Paper” on page 21.

• Close the printer door. See “Loading the Thermal

Chart Paper” on page 21.

Paper” on page 21.

Discharged Battery” on page 76.

“Problem loading the following settings: <System> <ECG> * * * Using default settings.”

“Shutdown?” was pressed while printing a

“Temperature Error” Printer head temp is too high. Allow to cool, then try again.

“Test has not been saved. Continue shutdown?”

“Unable to communicate with workstation“

Problem loading your settings at startup. May indicate memory problems.

Rhythm ECG.

was pressed after printing an

Auto ECG.

• Configuration not correct.

• Cable not properly connected.

Contact Technical Support. For phone numbers, see

page ii.

To shut down, press .

To cancel the shutdown, press .

To shut down without saving the test, press .

To cancel the shutdown, press .

• Verify communication settings on the PC.

• Check cable connections.

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Directions for Use Chapter 8 Troubleshooting 87

Limited Warranty

Welch Allyn, Inc., warrants that the Cardiopulmonary line of electrocardiographs, including the CP 100 and CP 200 models (the Products) meet the labeled specifications of the Products and will be free from defects in materials and workmanship that occur within 3 years after the date of purchase, except that accessories used with the Products are warranted for 90 days after the date of purchase. Such accessories include: lead wires, cabling, electrodes, and battery.

The date of purchase is: 1) the date specified in our records, if you purchased the Product directly from us, 2) the date specified in the warranty registration card that we ask you to send to us, or 3) if you don’t return the warranty registration card, 30 days after the date on which the Product was sold to the dealer from whom you bought the Product, as documented in our records.

This warranty does not cover damage caused by: 1) handling during shipping, 2) use or maintenance contrary to labeled instructions, 3) alteration or repair by anyone not authorized by Welch Allyn, and 4) accidents.

If a Product or accessory covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period described above, Welch Allyn will, at its discretion, repair or replace the defective Product or accessory free of charge. If your Product requires repairs covered by this warranty, upon your request Welch Allyn will loan to you, at no cost, a substitute Product for use until your repaired Product is returned.

You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn’s designated service center for repair. Contact Welch Allyn Technical Support. For phone numbers, see page ii.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILTY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN’S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY.

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88 Chapter 8 Troubleshooting Welch Allyn CP 200 Electrocardiograph

Service Policy

All repairs on products under warranty must be performed or approved by Welch Allyn. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by Welch Allyn certified service personnel.

If the product fails to function properly—or if you need assistance, service, or spare parts—contact the nearest Welch Allyn Technical Support Center. For phone numbers, see page ii.

Before contacting Welch Allyn, try to duplicate the problem, and check all accessories to ensure that they are not causing the problem. When calling, please be prepared to provide:

• Product name and model number and complete description of the problem.

• Serial number of your product (if applicable).

• Complete name, address and phone number of your facility.

• For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number.

• For parts orders, the required spare or replacement part numbers.

If your product requires warranty, extended warranty, or non-warranty repair service, please call first the nearest Welch Allyn Technical Support Center. A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone, avoiding potential unnecessary returns.

In case a return cannot be avoided, the representative will record all necessary information and will provide a Return Material Authorization (RMA) number, as well as the appropriate return address. An RMA number must be obtained prior to any return.

If you have to return goods for service, follow these recommended packing instructions:

• Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate) before packing, unless you suspect they are associated with the problem.

• Wherever possible use the original shipping carton and packing materials.

• Include a packing list and the Welch Allyn Return Material Authorization (RMA) number.

It is recommended that all returned goods be insured. Claims for loss or damage to the product must be initiated by the sender.

Page 93

Specifications

Item Specification

Dimensions

Weight 11.6 lb (5.3 kg)

Keyboard type Elastomer keypad with complete alphanumeric keys

Paper type 8.25 x 11 inches (21 x 28 cm), Z-fold thermal paper, 200 sheets

Thermal printer (internal) Computer-controlled dot array, 8 dots/mm

Thermal paper speeds 10, 25, 50 mm/s

Gain settings:

Auto ECGs Rhythm ECGs

16.2 in (41.1 cm)

6.2 in (15.7 cm)

15.6 in (39.7 cm)

Soft-key menu and dedicated function keys

5, 10, 20 mm/mV, AUTO 5, 10, 20 mm/mV

Report print formats:

Auto ECGs Rhythm ECGs Average cycles

ECG storage Up to 50 ECGs

Frequency range 0.3 to 150 Hz

Digital sampling rate > 1,000 samples/second/channel

Pacemaker detection ANSI/AAMI EC11

Power requirement Universal AC power supply 100–240 V ~, 50/60 Hz ~, 2.2 A maximum

Fuses

AC DC (battery fuse)

Lead configurations Standard, Cabrera

Rechargeable battery Lead acid gel, 6 volt, 5 AH

3x4, 3x4+ 1R, 3x4 +3R, 6x2, 12x1, 6x2 50 mm/s, 6x2 Ext. 3, 6, or 12 leads at a time 3x4 50 mm/s + 3R, 6x2 50 mm/s + 6R

Time-delay type, 2 amp 250 V rating, Littlefuse 0215002 or equivalent. Fast-acting type, 10 amp 32 V rating, Bussman ATC-10 or equivalent.

Prints up to 100 continuous ECGs per charge 12-hour recharging

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90 Appendix A Specifications Welch Allyn CP 200 Electrocardiograph

Item (Continued) Specification (Continued)

Filters 0.5 Hz high-performance baseline filter

35 Hz muscle-tremor filter AC-interference filter 50 Hz or 60 Hz

Safety, EMC, and regulatory compliance

Standard connectivity Com port, SD memory card slot (for use with cards ≥ 64 MB)

Connectivity with electronic medical records

Electrodes Rigorously tested for conductivity, adhesion, and hypoallergenic qualities, and

Cables and wires Meet or exceed IEC 60601

Environmental operating conditions:

Temperature Relative humidity Altitude

Environmental storage conditions:

Temperature Relative humidity Altitude

Protection against electric shock Class I, internally powered

ANSI/AAMI EC11* UL60601-1 CAN/CSA C22.2 No. 601.1 IEC/EN 60601-1 CAN/CSA C22.2 No. 601.1.1 IEC/EN 60601-1-1 CAN/CSA C22.2 No. 601.1.2 IEC/EN 60601-1-2 CAN/CSA C22.2 No. 601.1.4 IEC/EN 60601-1-4 CAN/CSA C22.2 No. 601.2.25 IEC/EN 60601-2-25

Supported through the Welch Allyn CardioPerfect workstation software

exceed all AAMI standards

+10° C to +40° C (+50° F to +104° F) 15 – 95% noncondensing 700 – 1060 hPa

-20° C to +49° C (-4° F to +120° F) 15 – 95% noncondensing (30 – 70% for printing) 500 – 1060 hPa

Typ e BF

Protection against ingress of water, per IEC 60529

Mode of operation Continuous

*Per AAMI EC11:1991/(R)2001 Diagnostic Electrocardiographic Devices, Section 3.1.2.1 Disclosure of cautionary information/ performance characteristics paragraph c) Accuracy of input signal reproduction, the manufacturer shall disclose the methods used to establish overall system error and frequency response. Welch Allyn has used methods A & D, as prescribed in section 3.2.7.2 and 4.2.7.2 of this same standard, to verify overall system error and frequency response. Because of the sampling characteristics and the asynchronism between sample rate and signal rate, digital ECG systems such as the CP 100 and CP 200 may produce a noticeable modulating effect from one cycle to the next, particularly in pediatric recordings. This phenomenon is not physiologic.

Specifications are subject to change without notice.

IPX0

Page 95

EMC Guidance and Manufacturer’s

Table 5. Electromagnetic Emissions

The CP 200 electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or user of the CP 200 electrocardiograph should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Declarations

Group 1 The CP 200 electrocardiograph uses RF energy only for its internal function. Therefore,

its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A The CP 200 electrocardiograph is suitable for use in all establishments other than

domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Class A

Complies

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92 Appendix B EMC Guidance and Manufacturer’s Declarations Welch Allyn CP 200 Electrocardiograph

Table 6. Electromagnetic Immunity

Immunity Test IEC 60601

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/ burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines.

IEC 61000-4-11

Power frequency (50/60Hz) magnetic field

Test Level

± 6 kV contact

± 8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

>95% dip in 0.5 cycle

60% dip in 5 cycles

30% dip for 25 cycles

>95% dip in 5 seconds

3 A/m 3 A/m Power frequency magnetic fields should be at levels

Compliance Level Electromagnetic Environment - Guidance

± 6 kV contact

± 8 kV air

±2 kV for power supply lines

Not applicable

±1 kV differential mode

±2 kV common mode

>95% dip in 0.5 cycle

60% dip in 5 cycles

30% dip for 25 cycles

>95% dip in 5 seconds

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CP 200 electrocardiograph requires continued operation during power mains interruptions, it is recommended that the CP 200 electrocardiograph be powered from an uninterruptible power supply or battery.

characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8

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Directions for Use Appendix B EMC Guidance and Manufacturer’s Declarations 93

Table 7. Electromagnetic Immunity

Immunity Test IEC 60601

Test Level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance

Electromagnetic Environment - Guidance

Level

Portable and mobile RF communications equipment should be used no closer to any part of the CP 200 electrocardiograph, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

3 Vrms d = (1.17)

3 V/m d = (1.17) 80 MHz to 800 MHz

d = (2.33) 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, each frequency range.

should be less than the compliance level in

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CP 200 electrocardiograph is used exceeds the applicable RF compliance level above, the electrocardiograph should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the electrocardiograph.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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94 Appendix B EMC Guidance and Manufacturer’s Declarations Welch Allyn CP 200 Electrocardiograph

Table 8. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CP 200 Electrocardiograph

The CP 200 electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the CP 200 electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CP 200 electrocardiograph as recommended below, according to the maximum output power of the communications equipment.

Separation Distance According to Frequency of Transmitter (m)

Rated Max. Output

Power of Transmitter

(W)

0.01 0.117 0.117 0.233

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

150 kHz to 80 MHz

d = (1.17)

P P P

80 MHz to 800 MHz

d = (1.17)

800 MHz to 2.5 GHz

d = (2.33)

Page 99

Glossary

AHA. An abbreviation for American Heart Association. The AHA electrode labeling scheme is most

commonly used in the United States.

audit trail. A collection of information about user activity. The audit trail, which can be enabled or

disabled, may be helpful or even required for record-keeping.

Auto ECG. A report typically showing a 10-second acquisition of 12 leads of ECG information combined

with patient data, interpretation, and measurements matrix. Two user-defined formats are available: Auto Report 1 and Auto Report 2. See also Rhythm ECG.

Auto Save. A feature that automatically saves all Auto ECGs (except stat ECGs) to the test directory.

Auto Send. A feature that automatically sends all Auto ECGs (except stat ECGs) to the option of your

choice: SD memory card or CardioPerfect workstation.

average cycles. Dominant waveforms for all 12 leads. Printed on a separate page, if enabled.

CardioPerfect workstation. A PC using Welch Allyn CardioPerfect software. Stores ECG and spirometry

test data. Can communicate with other electronic patient-information systems, such as billing and medical records.

confirmed, unconfirmed. Status of an Auto ECG report’s interpretation. Indicates whether the report has

been reviewed and accepted by a qualified physician.

electrocardiogram (ECG). A record of the electrical currents associated with heart muscle activity.

Sometimes called EKG for the German term, Elektrokardiogramm. See also Auto ECG; Rhythm ECG.

electrocardiograph. An instrument used to create electrocardiograms (ECGs).

extended measurements. Values for several common parameters, such as Q, R, and S amplitude and

ST values. The amplitudes are expressed in microvolts. The durations are expressed in milliseconds. The measurements cannot be edited. Printed on a separate page, if enabled.

IEC. An abbreviation for International Electrotechnical Commission. The IEC electrode labeling scheme is

most commonly used in Europe.

lead. (1) An electrocardiograph wire connected to an electrode, which is attached to a patient’s skin.

There are 10 lead wires. (2) A waveform that represents ECG data from a particular view of the heart. The data from the 10 lead wires is converted into 12 waveforms, also called leads: I, II, III, aVR, etc.

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96 Glossary Welch Allyn CP 200 Electrocardiograph

MEANS. An acronym for modular ECG analysis system. The optional MEANS interpretation algorithm,

developed by the University of Rotterdam, Netherlands, provides automatic analysis of ECG tests.

patient list. See scheduled patients list.

Power-Save. A user-selectable feature that automatically turns the electrocardiograph off after several

idle minutes.

Rhythm ECG. A continuous, real-time printout of ECG data. See also Auto ECG.

scheduled patients list. A list of patients whose data has been entered into the electrocardiograph’s

memory for an ECG or spirometry test that day. This list can hold up to 40 patients. At midnight every night, the list is automatically cleared. When performing Auto ECG or spirometry tests, you may select patients from this list rather than manually entering their data at the time of the test.

test directory. A location in the electrocardiograph’s memory that holds up to 50 ECG and 50 spirometry

tests. When performing Auto ECG or spirometry tests, you may select patients from this directory rather than manually entering their data at the time of the test.

workstation. See CardioPerfect workstation.