Welch Allyn CP 200 User Manual

CP 200™ 12-Lead Resting Electrocardiograph

Directions for Use

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 Welch Allyn 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 + 331 6009 3366

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

Latin America + 1 305 669 9003 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

Reorder Number (multi-language CD): 401151 Mat. Number (manual only): 708793, Ver: F

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

Welch Allyn LTD. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: 353-46-90-67700 Fax: 353-46-90-67755

www.welchallyn.com

Printed in USA

Contents

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

iii

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

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

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

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

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

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Controls, Indicators, and Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

About the Main Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Moving Through the Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

About the Patient Cable and Leads. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Using the Electrocardiograph Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

General Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

General Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Getting Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2 - Setting Up the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . 21

Inspecting the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Connecting the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Loading the Thermal Chart Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Powering the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Verifying Proper Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Connecting an External USB Printer (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . 26

3 - Reviewing the System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

“System Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Reviewing the Device Configuration Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Reviewing the Device Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Reviewing the Connectivity Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Reviewing the Medication List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Reviewing the History List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Transferring a Configuration to Another Electrocardiograph . . . . . . . . . . . . . . . . 35

Configuring the Electrocardiograph for Wireless Communication . . . . . . . . . . . 36

4 - Reviewing the ECG Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

“ECG Settings” Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

About Auto ECG Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

iv Contents Welch Allyn CP 200 Electrocardiograph

Reviewing the Format Settings for Auto Reports. . . . . . . . . . . . . . . . . . . . . 41

Reviewing the Interpretation and Copy Settings for Auto Reports. . . . . . . . 43

Reviewing the Patient Data Fields Available for Auto Reports . . . . . . . . . . . 44

Reviewing the Auto Report Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Reviewing the Rhythm Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Reviewing the Miscellaneous ECG Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Turning the Augmented Pediatric Lead Set On and Off . . . . . . . . . . . . . . . . . . . 49

5 - Performing ECG Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Connecting the Leads to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Recording an Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Recording a Normal Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Recording a Stat Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Recording a Rhythm ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Recalling Saved Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Adjusting the ECG Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

6 - Performing Administrative Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Managing Saved Tests In the Test Directory . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Managing the Scheduled Patients List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Managing Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Working With the User List and User Login. . . . . . . . . . . . . . . . . . . . . . . . . 76

Working With the Audit Trail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

7 - Maintaining the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . 79

Inspecting the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Cleaning the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Testing the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Recharging a Fully Discharged Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Replacing the Battery (DC) Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Replacing the AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Storing the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Discarding the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

8 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Problem-Solving Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

A - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

B - EMC Guidance and Manufacturer’s Declarations . . . . . . . . . . . . . 97

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Introduction

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

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

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

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

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

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Controls, Indicators, and Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

About the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Moving Through the Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

About the Patient Cable and Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Using the Electrocardiograph Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Getting Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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 patientinformation systems, such as billing and medical records.

For details, see the following sections:

• “Standard Features & Benefits” on page 3

• “Options” on page 5

• “Specifications” on page 95

Intended Use

The Welch Allyn electrocardiography and spirometry products (subject devices) are intended for use by trained operators in health facilities. The subject devices provide the following diagnostic functions:

• Acquiring, viewing, storing, and printing ECG waveforms using ECG front end modules (patient cables) and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.

• Using optional algorithms to generate measurements, data presentations, graphical presentations and interpretative statements on an advisory basis. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the result of physical examination, the ECG tracings and other clinical findings.

• Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of the patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The spirometer should only be used with patients able to understand the instructions for performing the test.

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 ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities which must be confirmed by a physician with other relevant clinical information.

The optional spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.

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 removable media

Use SD™ memory cards or removable USB storage devices to save as many ECG or spirometry records as you like. (Media are not included.) If both an SD memory card and a USB storage device are connected, files are sent to the SD card. For media specifications, see “Standard connectivity” on page 96.

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:

• via an SD memory card or removable USB storage device (media not included)

• via a hardwired connection (cable not included)

• via a wireless connection

Compatibility with external printer

You can connect an external printer. For details, see “Connecting an External USB Printer

(Optional)” on page 26.

4 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Pacemaker detection

If the software detects the possible presence of a pacemaker, it asks you whether the patient has a pacemaker. If you say no, interpretation (if purchased) is included in the report. If you say yes, interpretation is not included in the report, and a message indicating that a pacemaker was detected is displayed on the report.

Support for augmented pediatric lead set

The augmented pediatric lead set, an alternate placement of the precordial leads on pediatric patients, is easier to use on the small chests of infants and young children. It provides optimal vectors for early development of the heart for the change of right-toleft ventricular dominance. For electrode placement locations, see Figure 33 on page 54.

Directions for Use Chapter 1 Introduction 5

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 or the PEDMEANS Physicians’ Manual on the CD that came with your electrocardiograph. The MEANS algorithm is used for adult patients 18 years and older. The PEDMEANS algorithm is used for pediatric patients from 1 day through 17 years old.

•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

• Bar code scanner

A bar code scanner is available for easy entry of patient ID numbers. This option includes a stand for mounting the bar code scanner to the cart.

• Wireless connectivity kit

Cable arm and shelf (optional)

Durable, highquality, rubber wheels with locks

This option provides a radio and PC software to enable wireless communication between your information network and the electrocardiograph. You can use the wireless link to send tests to the Welch Allyn CardioPerfect workstation, retrieve patient demographic information, or process orders from your EMR system via a Welch Allyn HL7 interface.

6 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

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 cup Limb lead clamps, IEC Limb lead clamps, AHA

Patient cable (Figure 12 on page 13)

•AHA

•IEC

• IEC, vacuum adapter

• Vacuum system

Lead wires (10 wires per set)

• AHA banana

• IEC banana

• AHA pinch

• IEC pinch

Battery (Figure 51 on page 83) Dust cover

Carts

• Utility cart

•Office cart (Figure 1 on page 5)

•Hospital cart (Figure 2 on page 5)

• Cable arm & shelf option (page 5)

Connectivity kit to the CardioPerfect workstation Wireless USB radio kit Bar code scanner kit

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

400293 400294 100920 VAC-DT100-CP

401129 401122 401123 401124

100660 701586

08265-0000 401393 401394 401161

100638 102103 102014

1000

1 case

1 4 4

1 1 1

1 set 1 set 1 set 1 set

1 1

1 1 1 1

1 1 1

Interpretation upgrade option 100623 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

708793 1

Directions for Use Chapter 1 Introduction 7

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 10.

)

1!2

@3#

4$5%6+7-8

(

Keyboard See Figure 1 on page 9.

Figure 4. Back

AC power inlet

Equipotential stud

AC fuses

8 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Figure 5. Right Side

Com port B (USB) SD memory card

Figure 6. Front

(for patient cable)

slot

Com port A

Spirometry port

Reset button

Figure 7. Left Side

Paper tray latch

Directions for Use Chapter 1 Introduction 9

Table 1. Keyboard

1!2

@3#

4$5%6+7-8

)

(

G FH

Key Function

A. On/Off See “Powering the Electrocardiograph” on page 24.

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

C. Menu See “About the Main Menu” on page 11.

D. Help See “Getting Help” on page 19.

E. Navigation arrows See “Moving Through the Menus” on page 12.

F. E nt e r S ee “Moving Through the Menus” on page 12.

G. Space Enters a space.

H. Control (Applicable only for keyboards with characters above certain keys.) To enter a

character above a key, hold the Ctrl key while pressing that key. To capitalize the character, hold Shift + Ctrl while pressing the key.

I. Shift Capitalizes letters. Also, you can enter a symbol (%, #, etc.) by holding the Shift key

while pressing a number key.

J. Tab Moves through the data-entry fields.

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

10 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

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 56.

Spirometry

Begins spirometry tests. See spirometry manual.

Rhythm ECG

Begins Rhythm ECGs. See “Recording a Rhythm ECG” on page 63.

Stop/Cancel

Stops any current activity. See “Moving Through the Menus” on page 12.

Accepts data that you have entered, or chooses a highlighted item. See “Moving Through the Menus” on page 12.

Directions for Use Chapter 1 Introduction 11

About the Main Menu

The main menu appears when you press the Menu key . (If you are in spirometry mode when you press this key, the Spirometry Settings menu appears.)

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 08

Submenu Purpose Procedure

Test Directory Edit, confirm, print, or send saved tests. See “Managing Saved Tests In the Test

Directory” on page 70.

Scheduled Patients View the scheduled patients list, add

patients to the list, or delete patients from

See “Managing the Scheduled Patients List” on page 74.

the list.

ECG Settings Review or change ECG settings: Auto

Report format, Rhythm Report format, and

See “Reviewing the ECG Settings” on page 37.

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 27.

See “Reviewing the Medication List” on page 33.

See “Reviewing the History List” on page 34.

12 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

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 08

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 08

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

12x1

6x2 50 mm/s 6x2 Ext. 2x6+1R

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 or

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

Note

Keyboard and softkey arrows work the same way.

Directions for Use Chapter 1 Introduction 13

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

Cable rake

Right arm lead

Left arm lead

Left leg lead

Electrocardiograph connector

Right leg lead

14 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

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

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 Australian registered importer

N344

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

Directions for Use Chapter 1 Introduction 15

For details on the keys, see Figure 1 on page 9.

Operation Symbols

On/standby (off) Help

Navigation arrows Backspace

Enter Shift

Auto ECG Menu

Rhythm ECG Stop/Cancel

Spirometry OK

Spirometry port Com port B (USB)

SD memory card slot Com port A

(for patient cable)

Alternating current Battery charge level

Battery is charging. Battery is charged.

T2.0A/250V

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.

16 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

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 97.

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 might 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. In the case of a USB printer, the printer (non-medical electrical equipment) shall be situated outside the patient environment (reference IEC 60601-1-1). The printer used should be approved to the appropriate safety standard for non-medical electrical equipment (IEC 60950, or its national variants), and use of an isolation transformer is recommended. If there is a requirement for the printer to be situated within the patient environment it is the responsibility of the user to ensure that the system provides a level of safety in compliance with IEC 60601-1 and 60601-1-1.

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

Directions for Use Chapter 1 Introduction 17

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 22.

• 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 80.

• 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.

18 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

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 97.

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.

Directions for Use Chapter 1 Introduction 19

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 Status 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 6.

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

20 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph

Setting Up the Electrocardiograph

Inspecting the Electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Connecting the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Loading the Thermal Chart Paper. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Powering the Electrocardiograph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Verifying Proper Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Connecting an External USB Printer (Optional) . . . . . . . . . . . . . . . . . . . . . . . 26

22 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 5 and “Accessories” on page 6.

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 13.)

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 17.

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

Directions for Use Chapter 2 Setting Up the Electrocardiograph 23

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.

24 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 97.

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: . Whenever the battery is charging and is not yet fully charged, this icon appears: . For maximum battery performance, as often as possible leave the electrocardiograph plugged in until you see the “fully charged” 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 82.

Figure 18. AC Power Inlet and Green LED

AC power inlet

On/Off key

Green LED

@3#

1!2

4$5%6+7-8

)

(

Directions for Use Chapter 2 Setting Up the Electrocardiograph 25

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 29.

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 81.

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 29.

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

• “Reviewing the System Settings” on page 27

• “Reviewing the ECG Settings” on page 37

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

Connecting an External USB Printer (Optional)

If desired, you can connect an external printer. It must be a USB inkjet or laser printer that supports PCL (printer control language), such as the following:

Vendor Model PCL Version

HP Deskjet 995c PCL 3

HP Deskjet 5650 PCL 3 enhanced

HP Laser 1022 PCL 5E

Dell Laser 1710 PCL 5E & PCL 6

Lexmark Laser E240 PCL 6

No special software is required.

The external printer prints the following (always in black and white):

• Auto ECG reports

• Spirometry reports (spirometry option only)

• Device settings

• Audit trails

• Help pages

Rhythm ECGs always print to the internal printer.

See the warning regarding signal I/O connectors on page 16.

To Connect a Printer

Connect one end of a USB cable to the printer’s USB connector, and connect the other end to the electrocardiograph’s USB connector: . For connector location, see Figure 5 on page 8.

To learn how to enable the external printer in the settings, see “Reviewing the Device

Configuration Settings” on page 29.

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