Copyright 2005, Welch Allyn, Inc. 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 100 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 8797China + 86 216 327 9631
European Call Center + 353 46 906 7790France + 33 15 569 5849
Germany + 49 747 792 7186Japan + 81 33 219 0071
Latin America + 1 315 685 2644Netherlands + 31 15 750 5000
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 100 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 100 electrocardiograph features a full alphanumeric keyboard, an LCD
display, full-size user-programmable reports, and the ability to operate on either battery or
AC power.
ECG tests sent to a memory card are compatible with the 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 67
Intended Use
The CP 100 electrocardiograph is specifically intended for acquiring 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.
Directions for UseChapter 1 Introduction3
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 patient information quickly and easily.
LCD display
Enter data and program the system easily.
Unlimited storage on SD™ memory cards
Use SD memory cards to save as many ECG 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 format
Customize the report format 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 (card not included).
These options are available both for initial purchases and for upgrades.
•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
Directions for UseChapter 1 Introduction5
Accessories
To order accessories, call Welch Allyn. For phone numbers, see page ii.
ItemCustomer Order NumberQuantity
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 11 on page 11)
•AHA
•IEC
• IEC, vacuum adapter
Lead wires (10 wires per set)
• AHA banana
• IEC banana
• AHA pinch
• IEC pinch
Battery (Figure 36 on page 55)
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
To return to the Ready screen from a standard menu
(Figure 9)
(To make no change.)
Directions for UseChapter 1 Introduction11
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.
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 upKeep dry
FragileProtected against drops of liquid falling at an
+49°C
Temperature limitsAltitude limits
Relative humidity limit
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
IPX2
N344
angle up to 15° from vertical
Complies with applicable U.S. and Canadian
medical safety standards
Australian registered importer
Directions for UseChapter 1 Introduction13
For details on the keys, see Figure 1 on page 8.
Operation Symbols
On/standby (off)Help
Navigation arrowsBackspace
EnterShift
Auto ECGMenu
Rhythm ECGStop/Cancel
SD memory card slotCom port A
(for patient cable)
Alternating currentBattery charge level
Earth groundDirect current
Dangerous voltageGround equipotential
Defibrillator-proofSealed lead-acid battery
Do not reuse.
Dispose of electrical and electronic
equipment separately.
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.
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 69.
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.
Directions for UseChapter 1 Introduction15
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 52.
•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.
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 69.
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.
Directions for UseChapter 1 Introduction17
Getting Help
You can get help with the electrocardiograph in a variety of ways beyond this manual.
•Press the Help key from the Ready 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.
20Chapter 2 Setting Up the ElectrocardiographWelch Allyn CP 100 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 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 12. (To see the whole patient cable with all leads inserted,
see Figure 11 on page 11.)
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 15.
2. Plug the patient cable into the port on the front of the electrocardiograph.
See Figure 13.
Figure 12. Inserting the LeadsFigure 13. Plugging in the Connector
Metal ring
Directions for UseChapter 2 Setting Up the Electrocardiograph21
Loading the Thermal Chart Paper
1.Squeeze the latch. Pull the paper door to the left. See Figure 14.
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 15.
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 16.
Figure 14. Opening the Paper DoorFigure 15. Loading the Paper
Latch
Figure 16. 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.
22Chapter 2 Setting Up the ElectrocardiographWelch Allyn CP 100 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 69.
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 17.
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 54.
Figure 17. AC Power Inlet and Green LED
AC power inlet
On/Off key
Green LED
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