Welch Allyn CP Series Electrocardiographs User Manual
CP Series
Electrocardiographs
CP 100
Update to Directions for Use
CP 200
ii Welch Allyn CP Series Electrocardiographs
Copyright 2011 Welch Allyn
Mat. Number: 717481, Ver: A
Welch Allyn
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Skaneateles Falls, NY 13153
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Printed in USA
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+ 1 315 685 4560
Regulatory Affairs Representative
Welch Allyn Limited
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Navan, County Meath, Republic of Ireland
Australia + 61 2 9638 3000
New Features for this Release
If your CP 100 electrocardiograph has a serial number of 10020000, or greater, or your
CP 200 electrocardiograph has a serial number 20020000, or greater, this update
describes the changes in the operation of your electrocardiograph.
If your electrocardiograph has a serial number that is lower than 1002000 or 2002000, and
your device was recently serviced, it may contain some or all of these new features
depending on the scope of the services performed.
This document supplements information in the following manuals:
• CP 100 12-Lead Resting Electrocardiograph Directions for Use (mat. 708794)
• CP 200 12-Lead Resting Electrocardiograph Directions for Use (mat. 708793)
• CP 200 Spirometry Option Directions for Use (mat. 708795)
1
Battery Deep-Discharge Disconnect Added
A battery deep-discharge disconnect has been added to reduce the likelihood that your
CP 100 or CP 200 electrocardiograph will operate on a deeply discharged battery. The
disconnect prevents permanent damage to the battery when the battery is left uncharged
for long periods of time.
This functions automatically when the electrocardiograph battery voltage is less than
5.25V in sleep mode. Once a battery disconnect has occurred, the electrocardiograph will
not operate on battery power until it is charged to 6.2V or higher. This also protects the
electrocardiograph from operating on a malfunctioning battery that cannot be charged to
6.2V or higher.
Reset Button
If the electrocardiograph stops functioning, you can press and hold the Power On/Off key
for approximately 7 seconds to restart the electrocardiograph. Release the key once the
restart begins. The key is located on the upper left of the electrocardiograph keyboard.
Figure 1. Reset Button
Press and hold
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3
4$5%6+7-8
(
*
9
0
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1!2
)
2 Welch Allyn CP Series Electrocardiographs
The previous method of resetting the electrocardiograph is still available. Reset the
electrocardiograph by pressing the reset button located on the right side. To press the
reset button, insert a small object, such as small paper clip, into the hole next to the
Spirometry port.
Bi-Colored Keyboard LED
Figure 2. Keyboard LED
The bi-colored LED on the keyboard
Bi-colored LED
indicates the battery status. When green,
the LED indicates that AC power is
present. When yellow, the LED indicates a
low battery that should be charged. The
1!2
@
#
3
4$5
+
%
6
LED is located below the Power On/Off
key on the upper left of the
electrocardiograph keyboard.
Alternate Patient Cable and Leads
The Lead configuration has changed so that all individually replaceable lead wires extend
from the same end of the patient cable. This new configuration is intended to make the
connection of the lead wires easier for you. It is different now then it has been in previous
models where the LL (F) and RL (N) leads attached to the opposite end of the patient
cable with respect to the other leads. See Figure 3“Patient Cable and Leads”.
Figure 3. Patient Cable and Leads
Chest leads
Cable
rakes
Left leg lead
Right leg lead
Left arm lead
Electrocardiograph
connector
Right arm lead
There has been no change to the replaceable lead wires. They remain compatible with
previous models and are equivalent in function.
New Features for this Release 3
Connecting the Patient Cable
Insert all leads into their proper positions, as labeled on the connectors. See Figure 4
“Inserting the Leads”.
Figure 4. Inserting the Leads
Updated Information for the CP 100/CP 200
Heart rate monitor operation
The heart rate indicated on the CP 100 or CP 200 LCD display is for reference only. Make
manual measurements of the ECG intervals and magnitudes on printed ECG reports only.
The increased R wave amplitudes that are produced by some patient simulators may
produce heart rate readings two times higher than normal because the R waves can be
counted as T waves.
The CP 100 and CP 200 devices are not intended to be used as heart rate monitors. Heart
rate monitors are covered by other standards for example: ANSI/AAMI standard EC13:
Cardiac monitors, heart rate meters and alarms.
Artifact
A combination of abnormally large R wave amplitude and waveform shapes delivered by
some patient simulators can trigger artifact warnings. These warnings are not consistent
with actual patient morphologies. The noise warning is designed as a guide to limit low
quality ECGs.
The CP 100 and CP 200 devices are compliant to all applicable standards specified in the
device manual for diagnostic electrocardiographs including: IEC/EN 60601-2-51 and ANSI/
AAMI EC11.
Reducing Artifact
• Use only resting tab electrodes that have not past their product expiration date.
Store only in an air tight pouch within the product recommended environmental
conditions.
• When using the reusable bulbs, limb plates, or clamp electrodes, always replace
expired or dried up electrode gel.
• When using the reusable bulbs, limb plates, or clamp electrodes, use only an
ECG conductive gel to obtain optimum conductivity. Do not use ultrasound gel.
• Orient the adapter (alligator) clips so that the metal from the clip is able to make
contact with the conductive area of the resting tab electrode.
4 Welch Allyn CP Series Electrocardiographs
• Replace the patient lead if the banana spring at the end of the lead is broken or
damaged.
Updated Battery Information for the CP 100/CP 200
Electrocardiograph Battery - Preparation and Operation
Battery performance:
The sealed lead-acid battery provides 200 to 300 discharge/charge cycles under normal
operating conditions before it should be replaced. Typical battery usage will require
battery replacement approximately once per year. Reduced battery performance and
longevity will result if the recommendations for maximum battery performance are not
followed.
The electrocardiograph uses a single, rechargeable Sealed Lead Acid (SLA) battery pack. It
is designed to print up to 100 continuous rhythm ECG pages or to print 25 AUTO ECG
tests per full charge. The typical charge time of the sealed lead-acid battery is 12-16 hours,
but can take up to 36 hours for a highly discharged battery.
Prior to using your new electrocardiograph in battery mode:
Caution Charge the Battery. Upon receipt of your new electrocardiograph, it is
important to charge the electrocardiograph's battery for at least 12 hours before
using it in battery mode.
Note
The electrocardiograph is fully functional when connected to AC power,
regardless of the battery charge state. Using the electrocardiograph while
charging the battery does not affect the charge time.
New Features for this Release 5
For maximum battery performance and longevity:
• Charge the battery whenever possible by connecting the electrocardiograph to AC
power after each use.
The CP 100/CP 200 provides a trickle charge to keep the battery fully charged.
Continuous charging will maximize the battery performance and longevity and will
not overcharge or degrade the battery.
• Fully recharge the battery immediately after it becomes fully discharged. A fully
discharged battery without an immediate recharge may require an extended charge
time (up to 36 hours) and permanently degrade battery performance and longevity.
• Use only the CP 100/CP 200 electrocardiograph's integral charger to recharge the
battery.
• Use only a Welch Allyn CP 100/CP 200 approved replacement battery (REF 100660).
• Avoid using or storing your electrocardiograph in hot locations or in direct sunlight.
To check the battery charge status:
To fully charge the battery, leave the electrocardiograph plugged into AC power until you
see the fully charged indication on the display. A battery status symbol appears in the top
portion of the electrocardiograph display:
Note
Battery is charging
Electrocardiograph
Display
Battery fully charged (symbol will
appear solid white on the
electrocardiograph display)
Replace your battery if you are unable to perform your expected number of ECGs
per day after a full charge cycle. (12 hour minimum, up to 36 hours if deeplydischarged).
6 Welch Allyn CP Series Electrocardiographs
Update Through Software Version 2.5
This update describes changes in operation through software version 2.5 of the CP 100
and CP 200 electrocardiographs and the CP 200 spirometry option. This document
supplements information in the following manuals:
• CP 100 12-Lead Resting Electrocardiograph Directions for Use (mat. 708794)
• CP 200 12-Lead Resting Electrocardiograph Directions for Use (mat. 708793)
• CP 200 Spirometry Option Directions for Use (mat. 708795)
Lead Quality Feedback
CP 100, CP 200
Lead quality messages, which appear on various screens, now include both lead-off and
artifact information.
For good quality recordings, leads must be connected and artifact free. If you print an
Auto ECG despite lead-off or artifact conditions (by overriding the “Waiting for 10 seconds
of quality data” message), the report reflects those conditions. In the case of lead-off
signals, the report shows square waves. In the case of artifact, the report might include a
warning to use the interpretation (if any) with caution.
To eliminate artifact, you might need to re-prep the patient, use fresh electrodes, or
minimize patient motion during the recording.
For additional feedback on lead quality, you can now enable an artifact report. This report,
a 12x1 format with all filters disabled, shows the leads with artifact so that you can
remedy the problem. (The normal Auto ECG report with filters enabled might mask some
of the artifact issues.) When enabled, the artifact report prints automatically with the Auto
ECG report whenever artifact is detected and you override the “Waiting for 10 seconds of
quality data” message.
To enable the artifact report, press the Menu key . Choose ECG Settings >
Auto Report Settings > Artifact Report > On.
Heart Rate
CP 100, CP 200
A four-beat average heart rate (HR) now appears in real time on the screen.
Body Mass Index
CP 100, CP 200
The patient’s body mass index (BMI) now appears on the Enter New Patient screen and
on ECG and spirometry reports when height and weight are entered.
Compliance With 60601-2-51
CP 100, CP 200
The electrocardiograph is in compliance with regulatory standards CAN/CSA C22.2
No. 60601.2.51 and IEC/EN 60601-2-51. For manufacturer's disclosures regarding
60601-2-51, please contact Welch Allyn Customer Service at the phone number listed in
the Directions for Use.
Update Through Software Version 2.5 7
Pacemaker Detection Prompt
CP 100, CP 200
If the software detects the possible presence of a pacemaker, it now 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. This prompt was added
to prevent false pacemaker pulses caused by environmental interference.
Symbols and International Characters
CP 100, CP 200
You can now enter symbols and international characters using the keyboard.
To enter a symbol, hold the Shift key while pressing a number key. To enter an
international character, hold the Ctrl key while pressing a key with an international
character above it on the keyboard label. To capitalize an international character, hold
Shift + Ctrl while pressing the key.
CAPS Lock
CP 100, CP 200
You can now turn CAPS Lock on and off in the software. This feature works just like a
standard Caps Lock key.
To turn CAPS Lock on or off, press the Menu key .
Choose System Settings > Device Configuration > CAPS Lock > On or Off.
Swedish, Danish, and Finnish Patient ID Processing
CP 100, CP 200
When you enter a valid Swedish, Danish, or Finnish patient ID, the patient’s date of birth/
age, gender, and race are now automatically filled in.
“Repeat Test” Softkey
CP 200
The ECG post-print screen now includes a Repeat Test softkey to let you more efficiently
repeat a test.
8 Welch Allyn CP Series Electrocardiographs
Test Directory Usability
• CP 200
More convenient searching
When searching the test directory, you can now enter partial search criteria in the
Patient ID or Last Name fields. For example, to find all patient IDs starting with 12
(including 129374, 12579-125, and 12049-7564), you would enter 12 in the Patient ID
field. To find all patients with last names starting with Jo (including Jones, Johnson,
and Johnston) you would enter Jo in the Last Name field.
Note: Searching is case-insensitive.
• Flexibility in selecting tests from search results
You can now select tests from test directory search results in various ways instead of
all tests being automatically selected.
To select a contiguous group of tests, press and hold Shift while pressing an arrow
key. To select an individual test, press an arrow key. To select all tests, press Ctrl-A.
• Ability to delete saved tests
To delete tests, press the Menu key . Choose Test Directory. Fill in the criteria,
and press Search. In the Search Results screen, choose the tests that you want to
delete. Press the Delete softkey.
External Printer
CP 100, CP 200
You can now 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
Printouts are always black and white.
When the external printer is selected in the Device Configuration screen and is powered
on and connected to the electrocardiograph, it prints the following:
• Auto ECG reports
• Spirometry reports (CP 200 spirometry option only)
• Device settings
• Audit trails (CP 200 only)
• Help pages
Rhythm ECGs always print to the internal printer.
To connect a printer, simply connect one end of a USB cable to the printer’s USB
connector, and connect the other end to the electrocardiograph’s USB connector.
No special software is required.
Update Through Software Version 2.5 9
To select a printer, press the Menu key .
Choose System Settings > Device Configuration > Printer Select > Internal or
External.
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.
Removable USB Storage Devices
CP 100, CP 200
You can now send tests to removable USB storage devices. If both an SD memory card
and a USB storage device are connected, files are sent to the SD card. The capacity of an
SD card must be >64MB,< 2 GB.
Note
The CP 100 and CP 200 do not support SD card capacities greater than 2 GB
including SDHC and SDXC high capacity SD card formats, or other USB storage
devices that have software applications pre-installed such as SanDisk U3 Smart
technology.
Contact Information for Accessories
CP 100, CP 200
It is now possible to enter contact information that will appear on the accessories
Help page.
To enter or review the contact information, press the Menu key . Choose
System Settings > Device Configuration > Contact Information.
Reset Button
CP 100, CP 200
If the electrocardiograph is unresponsive for an extended time, it might be “frozen.”
If this occurs, reset the electrocardiograph by pressing the reset button located on the
right side. To press the reset button, insert a small object, such as small paper clip, into
the hole.
10 Welch Allyn CP Series Electrocardiographs
Reset button
Improved Battery Status Feedback
CP 100, CP 200
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: .
New Auto ECG Report Format
CP 100, CP 200
There is a new Auto ECG report format: 2x6 +1R (2 rows x 6 columns+1rhythm lead).
Configurable Default Rhythm Speed
CP 200
You can now change the default rhythm speed: 10, 25, or 50 mm/s.
To change this default, press the Menu key . Choose ECG Settings >
Rhythm Report Settings > Default Rhythm Speed.
Transferable Configurations
CP 100, CP 200
You can now transfer the configuration of one electrocardiograph to another (CP 200 to
CP 200, or CP 100 to CP 100). If you have the spirometry option, its configuration is
included in the transfer.
To transfer a configuration, follow these steps:
1. Insert a storage device (SD memory card or USB flash drive) into an
electrocardiograph that is configured as desired.
2. Press the Menu key .
3. Choose System Settings > Device Info > Manage Settings > Export Files >
Export Configuration Files.
4. The files are copied to the storage device.
5. Remove the storage device, and insert it into another electrocardiograph of the
same model.
6. Choose System Settings > Device Info > Manage Settings > Import Files >
Import Configuration Files.
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