Directions for Use
112 Pages
Preview
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CP 200™ 12-Lead Resting Electrocardiograph
Directions for Use
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Welch Allyn CP 200 Electrocardiograph
Copyright 2008, Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from Welch Allyn. 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
Australia + 61 29 638 3000 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
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
www.welchallyn.com Printed in USA
Welch Allyn LTD. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: 353-46-90-67700 Fax: 353-46-90-67755
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Contents 1 - Introduction... 1 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
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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
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1 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
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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
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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.
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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
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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)
Cable arm and shelf (optional)
Free-motion plastic wheels
Durable, highquality, rubber wheels with locks
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 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.
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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
45008-0000 58581-0000 94018-0000 RE-ELEC-CUP RE-ELEC-CLP 401432
1000 10 1 case 1 4 4
Patient cable (Figure 12 on page 13) • AHA • IEC • IEC, vacuum adapter • Vacuum system
400293 400294 100920 VAC-DT100-CP
1 1 1
Lead wires (10 wires per set) • AHA banana • IEC banana • AHA pinch • IEC pinch
401129 401122 401123 401124
1 set 1 set 1 set 1 set
Battery (Figure 51 on page 83) Dust cover
100660 701586
1 1
Carts • Utility cart • Office cart (Figure 1 on page 5) • Hospital cart (Figure 2 on page 5) • Cable arm & shelf option (page 5)
08265-0000 401393 401394 401161
1 1 1 1
Connectivity kit to the CardioPerfect workstation Wireless USB radio kit Bar code scanner kit
100638 102103 102014
1 1 1
Interpretation upgrade option
100623
1
Spirometry option
100400
1
• Electrode placement wall poster
71300-0000
1
• CP 200 12-Lead Resting Electrocardiograph Directions for Use
708793
1
• CP 200 product information multi-language CD
401151
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Product information
Directions for Use
Chapter 1 Introduction
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*
9(
0)
Keyboard See Figure 1 on page 9.
Figure 4. Back
AC power inlet
Equipotential stud
AC fuses
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Chapter 1 Introduction
Welch Allyn CP 200 Electrocardiograph
Figure 5. Right Side
Com port B (USB)
SD memory card slot
Figure 6. Front
Com port A (for patient cable)
Figure 7. Left Side
Paper tray latch
Spirometry port
Reset button
Directions for Use
Chapter 1 Introduction
Table 1. Keyboard A
B
C
K 2@
1!
3#
4$
5%
6+
7-
8*
9(
D
0)
J
I H
G
F
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.
See “Moving Through the Menus” on page 12.
Enter
E
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.
Capitalizes letters. Also, you can enter a symbol (%, #, etc.) by holding the Shift key while pressing a number key.
Shift
J. Tab
Moves through the data-entry fields.
K. Green LED
Lights up when the electrocardiograph is connected to AC power.
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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 button has no effect. Auto ECG
Spirometry
Rhythm ECG
Stop/Cancel
OK
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. OK 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
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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 9:17AM Oct 16 08 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
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 the list.
See “Managing the Scheduled Patients List” on page 74.
ECG Settings
Review or change ECG settings: Auto Report format, Rhythm Report format, and so on.
See “Reviewing the ECG Settings” on page 37.
Spirometry Settings
Review or change spirometry settings: display settings, print settings, and so on.
See spirometry manual.
System Settings
Review or change system settings: device configuration, device info, user setup, and so on.
See “Reviewing the System Settings” on page 27.
Edit Medication List
Edit the list of medication choices available to choose during patient data entry.
See “Reviewing the Medication List” on page 33.
Edit History List
Edit the list of clinical conditions available to See “Reviewing the History List” on page 34. choose during patient data entry.
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Chapter 1 Introduction
Welch Allyn CP 200 Electrocardiograph
Moving Through the Menus Figure 10. Standard Menu
Figure 11. Parent Menu With Submenu 9:17AM Oct 16 08
9:17AM Oct 16 08 Edit Auto Report 1
Format
1 Format 2 Interp Settings 3 Patient Data 0 Previous Menu
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
3x4 3x4 +1R 3x4 +3R 6x2 12x1 6x2 50 mm/s 6x2 Ext. 2x6+1R
Keys to Press
To move up or down a list
or
To open a standard menu (Figure 10)
or
(keyboard or softkey arrows) or
or item’s number or letter
To move from parent menu to submenu on same screen (Figure 11) To perform an action To accept data To check or uncheck a checkbox To return to parent menu from submenu on same screen (Figure 11)
or
(To select the highlighted submenu item.)
or or
To move back through the menus
or zero key
To move through data-entry fields
or
(To make no change.)
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
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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
Left leg lead
Electrocardiograph connector
Right arm lead Right leg lead
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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
+49°C
This end up
Keep dry
Fragile
Relative humidity limit
Temperature limits
Altitude limits
-20°C
Certification Symbols Meets essential requirements of European Medical Device Directive 93/42/EEC
Complies with applicable U.S. and Canadian medical safety standards
European Regulatory Manager
Australian registered importer N344
Directions for Use
Chapter 1 Introduction
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Operation Symbols For details on the keys, see Figure 1 on page 9. 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.
Dangerous voltage
Direct current
AC fuse replacement information
Ground equipotential
Do not reuse.
Sealed lead-acid battery
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.
Recycle.
T2.0A/250V
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
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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.