Welch Allyn CP 150 12 User manual

CP 150 12-lead resting
electrocardiograph
Directions for use

© 2013 Welch Allyn, Inc. To support the intended use of the product described in this publication, the purchaser of
the product is permitted to copy this publication, for internal distribution only, from the media provided by 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. CP 150, and CardioPerfect are trademarks of Welch Allyn,
Inc.
Patent information
For patent information, please visit www.welchallyn.com/patents.
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.
Welch Allyn Technical Support:
http://www.welchallyn.com/about/company/locations.htm
105325 (CD)
DIR 80018069 Ver. A
105313 (printed copy)
Material Number 720134, DIR 80018069 Ver. A
Welch Allyn
4341 State Street Road
Skaneateles Falls, NY 13153-0220 U.S.A
www.welchallyn.com
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland

Contents
Introduction ............................................................................................. 1
About this document ........................................................................................... 1
Intended use ........................................................................................................ 1
Indications for use ................................................................................................ 1
Contraindications ................................................................................................. 1
Description ........................................................................................................... 2
Features ............................................................................................................... 2
Controls, indicators, and connectors .................................................................... 3
Symbols ............................................................................................................... 5
General warnings ................................................................................................. 7
General cautions .................................................................................................. 9
Setup ...................................................................................................... 11
Connecting the patient cable ............................................................................. 11
Loading the thermal paper ................................................................................. 11
Powering the electrocardiograph ....................................................................... 12
Verifying proper operation .................................................................................. 12
Connecting to a CardioPerfect workstation ....................................................... 13
To connect to a network-connected workstation via Ethernet cable ................. 13
ECG home screen .................................................................................. 15
ECG home screen .............................................................................................. 15
ECG tests ................................................................................................ 19
Attaching the leads to the patient ...................................................................... 19
Electrode locations ............................................................................................. 21
Viewing electrode placement ............................................................................ 22
Performing an Auto ECG test ............................................................................ 22
Saved tests ............................................................................................. 27
Searching for saved tests .................................................................................. 27
Managing the saved tests .................................................................................. 27
Settings .................................................................................................. 29
Viewing or changing the ECG settings .............................................................. 29
Selecting the device information ....................................................................... 30
Maintenance .......................................................................................... 33
Cleaning the equipment ..................................................................................... 33
Inspecting the equipment .................................................................................. 34
Testing the electrocardiograph .......................................................................... 34
Replacing the battery ......................................................................................... 35
iii

Replacing the AC fuses ...................................................................................... 35
Storing the equipment ....................................................................................... 36
Discarding the equipment .................................................................................. 36
Troubleshooting .................................................................................... 37
Lead-quality problems ........................................................................................ 37
System problems ............................................................................................... 40
Limited warranty ................................................................................................ 42
Service policy ..................................................................................................... 43
EMC guidance and manufacturer’s declarations ................................ 45
EMC compliance ................................................................................................ 45
Electromagnetic emissions ................................................................................ 45
Electromagnetic immunity ................................................................................. 46
Electromagnetic immunity ................................................................................. 47
Recommended separation distances between portable and mobile RF
communications equipment and the CP 150 electrocardiograph ...................... 48
Specifications ........................................................................................ 49
iv Contents CP 150 12-lead resting electrocardiograph

Introduction
About this document
This document is written for clinical professionals with a working knowledge of medical
procedures and terminology required for monitoring cardiac patients.
Before using the electrocardiograph for clinical applications — or before setting up,
configuring, troubleshooting, or servicing the electrocardiograph — you must read and
understand this document and all other information that accompanies the
electrocardiograph and related options or accessories.
Intended use
The Welch Allyn electrocardiography 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.
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.
Contraindications
The electrocardiograph has no known contraindications.
1

Description
• The electrocardiograph allows users to perform 12-lead ECG measurements and
analysis.
• The electrocardiograph supports STAT, Auto, and Rhythm test types.
• The electrocardiograph provides the ability to print test records on an internal printer
or external network printer.
• The electrocardiograph allows storage of test records in device memory, external
storage media, and external software applications.
Features
Pacemaker detection
The software detects the possible presence of a pacemaker. If you confirm that the
patient has a pacemaker, the ECG report includes no interpretation, and it indicates that
a pacemaker was detected.
Automatic ECG interpretation (optional)
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.
CAUTION Check for the presence of a pacemaker before using ECG with
interpretation.
2Introduction CP 150 12-lead resting electrocardiograph

Controls, indicators, and connectors
No. Feature Description
1 LCD screen 800 x 480 pixels color touchscreen provides a graphical user
interface.
2 Power switch and LED Power-on/Standby switch.
The LED indicates the charging status when connected to AC
power:
• Green: The battery is charged.
• Amber: The battery is charging.
3 Patient cable connector Provides connection for patient cable.
4 Printer Printer provides a printout of patient Auto ECG, Stat ECG, or
Rhythm ECG.
Directions for use Introduction 3

Back view
No. Feature Description
1 Ethernet connector Provides a hardwired connection to the computer network.
The LEDs indicate active network status when the ethernet cable
is connected to a network.
2 Clients USB USB, type "mini B." Provides connection to an enabled host.
3 Host USB USB, type "A." Provides four host USB connections for optional
accessories.
4 Power connection Provides an external AC power connection.
5 AC fuse Provides access to AC fuse.
6 Ground lug (equipotential terminal) Provided for electrical safety testing and as a means for
connection of a potential equalization conductor.
7 Battery compartment (behind cover) Houses the Li-ion battery.
4Introduction CP 150 12-lead resting electrocardiograph

Symbols
Documentation symbols
WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness, injury,
or death.
Caution The caution statements in this
manual identify conditions or practices
that could result in damage to the
equipment or other property, or loss of
data. This definition applies to both
yellow and black and white symbols.
Consult Directions for Use, Electronic
version available at Welchallyn.com, or
Hard copy DFU available from Welch
Allyn within 7 days.
Meets essential requirements of
European Medical Device Directive
93/42/EEC.
Power symbols
Power on/standby
(LED off) No AC power is present The battery is absent or faulty
(LED green) AC power is present, and
battery is charged. (LED amber) AC power
is present, and battery is charging.
The battery is charged to the indicated
level
Alternating current Battery is charging
Dangerous voltage Battery door
Fuse Rechargeable battery
Protective earth Nonionizing electromagnetic radiation
Equipotential terminal AC input power
Directions for use Introduction 5

Connectivity symbols
USB Ethernet (RJ-45 )
Shipping, storing, and environment symbols
This end up Keep dry
Fragile Relative humidity limit
Temperature limits Atmospheric air-pressure limits
Separate the battery from other
disposables for recycling
Recycle
Separate the device from other
disposables for recycling.
See www.welchallyn.com/weee.
China RoHS (restriction of hazardous
substances) symbols for control of
pollution caused by electronic
information products. 5-year
environment-friendly use period (EFUP)
for batteries. 10-year EFUP for the device.
For details, see the accompanying
documentation.
Lithium ion battery
Miscellaneous symbols
Manufacturer Defibrillation-proof Type CF applied parts
Reference/Model number Serial number
Reorder/Catalog number Batch code
6Introduction CP 150 12-lead resting electrocardiograph

Intertek ETL listed Do not reuse
General warnings
Warnings indicate conditions or practices that could lead to illness, injury, or death.
Warnings related to the environment
WARNING The power cord is considered the disconnect device for
isolating this equipment from supply mains. Do not position the equipment
so that it is difficult to reach or disconnect.
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 to keep them clear of the wheels and to minimize trip
hazards.
Warnings related to accessories and other equipment
WARNING To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.
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.
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.
WARNING The electrocardiograph has not been designed for use with
high-frequency (HF) surgical equipment and does not protect against
hazards to the patient.
WARNING Defective batteries can damage the electrocardiograph.
Visually inspect the battery at least monthly, if the battery shows any signs
of damage or cracking, it must be replaced immediately and only with a
battery approved by Welch Allyn.
WARNING Improper disposal of batteries may create an explosion or
contamination hazard. Never dispose of batteries in refuse containers.
Always recycle batteries according to local regulations.
Directions for use Introduction 7

WARNING All signal input and output (SIP/SOP) connectors should not be
contacted by patient directly and indirectly through the user during
operation.
Warnings related to using the electrocardiograph
WARNING No modification of this equipment is allowed.
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 or
prescribing treatment.
WARNING To provide CF protection use only accessories approved by
Welch Allyn. Visit www.welchallyn.com. The use of any other accessories
can result in inaccurate patient data, can damage the equipment, and can
void your product warranty.
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.
• 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 all components that come in contact with patients.
• 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 To ensure safe use of the device, follow the documented
maintenance procedures.
WARNING Only qualified service personnel should attempt to repair the
electrocardiograph. In case of a malfunction, call Technical Support.
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.
WARNING To maintain diagnostic accuracy and to comply with IEC
60601-02-51 and IEC 60601-02-25, do not scale (re size) when sending a
saved ECG to an external printer.
8Introduction CP 150 12-lead resting electrocardiograph

WARNING To avoid injury, do not touch the print head immediately after
printing. It might be hot.
General cautions
Cautions indicate conditions or practices that could damage the equipment or other
property.
CAUTION Federal US law restricts sale of the device identified in this
manual to, or on the order of, a licensed physician.
CAUTION When removing the electrocardiograph from storage, allow it to
thermally stabilize to surrounding environmental conditions before using it.
CAUTION To prevent possible damage, do not use sharp or hard objects
to press the touch screen or the buttons. Only use fingertips.
CAUTION Do not expose the patient cable to strong ultraviolet 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,
stretched, or stepped on. Otherwise, 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, including thermal paper, that
were supplied with the device and available through Welch Allyn. The use
of accessories other than those specified may result in degraded
performance or unsafe use 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
60601-1-2 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.
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, transporting, or servicing.
Directions for use Introduction 9

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 filters,
in any combination turned on or off, meet the AAMI requirements.
Measurements performed by the optional interpretation algorithm are
unaffected by any filter selections.
Note The entire patient cable, up to and including the electrodes are considered
to be an Applied Part.
10 Introduction CP 150 12-lead resting electrocardiograph

Setup
Connecting the patient cable
WARNING Do not allow the conductive parts of the patient cable,
electrodes, or associated connections of defibrillation-proof applied parts,
including the neutral conductor of the patient cable and electrodes, to
come into contact with other conductive parts, including earth ground.
Otherwise, an electrical short might result, risking electric shock to patients
and damage to the device.
WARNING To avoid injury to the patient or damage to the device, never
plug patient leads into any other device or wall outlet.
WARNING To provide CF protection use only accessories approved by
Welch Allyn. Visit www.welchallyn.com. The use of any other accessories
can result in inaccurate patient data, can damage the equipment, and can
void your product warranty.
CAUTION Always connect the patient cable and the leads properly during
defibrillation. Otherwise, the connected leads could be damaged.
Loading the thermal paper
The electrocardiograph prints on z-fold thermal paper.
•Store the paper in a cool, dry, dark place.
• Do not expose it to bright light or UV sources.
• Do not expose it to solvents, adhesives, or cleaning fluids.
• Do not store it with vinyls, plastics, or shrink wraps.
11

Powering the electrocardiograph
The electrocardiograph runs on AC or battery power. Plug the electrocardiograph into AC
power as often as possible so that the built-in charger can keep the battery charged.
Regardless of the battery condition, you can use the electrocardiograph whenever it is
plugged in.
WARNING When you use AC power, always plug the electrocardiograph
into a hospital-grade outlet to avoid the risk of shock.
WARNING If the integrity of the building’s safety ground is in doubt,
operate this device on battery power to avoid the risk of shock.
To turn on or turn off
Press .
Verifying proper operation
To ensure the accuracy of test data, you should verify proper operation of the
electrocardiograph before it is used for the first time with patients. You should reverify
proper operation once a year.
12 Setup CP 150 12-lead resting electrocardiograph

To verify proper operation
1. Use an ECG simulator to acquire and print a standard 12-lead ECG of known
amplitude and rate.
2. Look for the following indications of proper operation:
• 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).
• Thermal paper should move smoothly and consistently during printing.
• The waveforms should have no distortion or excessive noise.
• The amplitude and rate of the waveforms should match the input value from the
ECG simulator.
• Z-fold thermal paper should stop with perforations near the tear bar, indicating
proper cue-sensor operation.
3. If you see any indications of improper operation, contact Welch Allyn Technical
Support.
Connecting to a CardioPerfect workstation
You can connect a electrocardiograph to a Welch Allyn CardioPerfect workstation via
USB cable or via Ethernet cable. Software provided in the Connex Software Connectivity
Kit is required to communicate with the workstation. After you connect, you can perform
several functions from the electrocardiograph, including:
•Send ECG tests to the workstation.
• Search for patient data in the workstation database.
Cables longer than 3 meters have not been verified for use with the electrocardiograph.
Do not use cables longer than 3 meters.
To connect to a network-connected workstation via
Ethernet cable
1. Connect the electrocardiograph to the same network as the workstation. If you need
help, consult your network administrator.
WARNING To reduce the risk of fire and shock hazards,
connect Ethernet cables within the boundaries of a single
building. Ethernet cables that span multiple buildings can
introduce fire or shock hazards unless fiber optic cables or
lightning arrestors are properly installed or other appropriate
safety measures are taken.
Directions for use Setup 13

2. Go to the Network screen
a. Touch the Settings tab.
b. Touch the Device tab.
c. Touch the Network button.
3. Fill in the screen.
• If DHCP is enabled for the network, select the DHCP checkbox.
• If DHCP is not enabled, fill in the fields: Network IP address, Subnet mask, and
Default gateway.
4. Touch the Test with ping button.
5. Connect to the network.
a. In the Host Address field, enter the host IP address.
b. Touch the Ping Test button. The electrocardiograph pings the host.
6. Choose one of these to specify how to get DCP server IP information:
•Obtain server IP information automatically: Select this option if you want the
device to get the IP address, or if you don’t know the server’s IP address.
•DCP IP address: Fill in this field if your DCP server IP address is available.
• Fill in the UDP broadcast port field.
7. Touch Test connection.
8. Fill in the Remote file server address, User ID, and password.
9. Touch Test remote folder.
The electrocardiograph connects to the remote file server. The electrocardiograph is
ready to send tests to the remote file server. (To set up the workstation, see the
instructions that came with the workstation connectivity software.
14 Setup CP 150 12-lead resting electrocardiograph

ECG home screen
ECG home screen
The ECG home screen includes the following areas:
Item Area
1 Device status
2 Content
3 Navigation
Device status area
The Device status area, located at the top of the ECG home screen, displays:
•Time and date
• Battery status
• Error or information messages. These items are displayed until the condition has
been resolved.
15

Content area
The Content area includes 3 test selection buttons and a preview selection button:
•Auto ECG
•Rhythm ECG
•Stat ECG
•Electrode Placement
The content area also provides shortcuts to several controls.
About the test types
Auto ECG A report typically showing a 10-second acquisition of 12 leads of ECG information combined
with patient data, measurements, and optional interpretation. Auto ECGs can be saved to
the electrocardiograph’s test directory or to a USB mass-storage device.
Rhythm ECG A continuous, real-time printout of rhythm strips with a user-defined lead configuration.
Rhythm ECGs are printouts only. They cannot be saved.
Stat ECG An auto ECG that starts without waiting for you to enter patient data or adjust the
waveforms.
Navigation area
The Navigation area includes the following tabs:
•ECG home: Displays ECG test types and provides shortcuts to several controls.
•Saved tests: Accesses the patient ECG tests.
•Settings: Accesses device configuration settings.
To navigate to a tab, touch the tab in the Navigation area with the corresponding name.
The active tab is highlighted.
16 ECG home screen CP 150 12-lead resting electrocardiograph