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 67754
0297
Welch Allyn
4341 State Street Road
Skaneateles Falls, NY
13153-0220 USA
www.welchallyn.com
DIR 80012822 Ver. C
CardioPerfect
Pocket ECG User - Manual
US Federal law restricts this device to sale by or on the
Caution
order of a physician.
Instructions for use
The information contained in this manual is subject to change without notice.
All changes will be in compliance with regulations governing manufacture of medical
equipment.
This product is designed to perform in conformity with the description thereof contained in this
operation manual and accompanying labels and inserts, when assembled, operated,
maintained and repaired in accordance with the instructions provided. A defective product
should not be used. Parts that are broken, plainly worn, missing or incomplete, distorted or
contaminated should be replaced immediately. Should any repair or replacement become
necessary, we recommend that service be performed at the nearest factory approved service
center. The user of the product shall have the sole responsibility for any malfunction, which
results from improper use, faulty maintenance, improper repair, damage or alteration by anyone
other than Welch Allyn or their authorized service personnel.
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Warranty, Service, and Spare Parts
Warranty
All repairs on prod
Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty,
any product repair shall exclusively be performed by Welch Allyn certified service personnel.
Assistance and Parts
If the produ
contact the nearest Welch Allyn Technical Support Center.
USA 1-800-535-6663 Canada 1-800-561-8797
Latin America (+1) 305-669-9003 South Africa (+27) 11-777-7555
European Call Center (+353) 46-90-67790 Australia (+61) 2-9638-3000
United Kingdom (+44) 207-365-6780 Singapore (+65) 6419-8100
France (+33) 1-55-69-58-49 Japan (+81) 3-6383-0852
Germany (+49) 695-098-5132 China (+86) 21-6327-9631
Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all
accessories to ensure that they are not the cause of the problem.
When calling, please be prepared to provide:
Product name and model number and complete description of the problem
The serial number of your product (if applicable)
The complete name, address and phone number of your facility
For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number
For parts order, the required spare or replacement part number(s)
Repairs
If your product requires warranty, extended warranty, or non-warranty repair service, please
call first the nearest Welch Allyn Technical Support Center. A representative will assist you
troubleshooting the problem and will make every effort to solve it over the phone, avoiding
potential unnecessary return.
In case the return cannot be avoided, the representative will record all necessary information
and will provide a Return Material Authorization (RMA) number, as well as the appropriate
return address. A Return Material Authorization (RMA) number must be obtained prior to any
return.
Packing Instructions
If you have to return goods for service, follow these recommended packing instructions:
Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate)
before packing, unless you suspect they are associated with the problem.
Wherever possible use the original shipping carton and packing materials.
Include a packing list and the Welch Allyn Return Material Authorization (RMA) number.
It is recommended that all returned goods be insured. Claims for loss or damage to the product
must be initiated by the sender.
ct fails to functio
ucts under warranty must be performed or approved by Welch Allyn.
n properly or if assistance, service, or spare parts are required,
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Table of Contents
1. GETTING STARTED ...................................................................................9
1.1 The Pocket ECG window.....................................................................................9
Welcome to CardioPerfect Pocket ECG, a Pocket PC-based Resting ECG recording system, a
mobile extension of the Welch Allyn CardioPerfect Workstation software.
With the CardioPerfect Pocket ECG, you can record, view and interpret Resting ECGs with
your Pocket PC. You can also use it to send and receive ECGs through the Welch Allyn
CardioPerfect Workstation Telemedicine functionality.
This manual contains specific information about the Welch Allyn CardioPerfect Pocket ECG.
The ECGs recorded with your Pocket ECG can be imported into the Workstation Software with
the Pocket ECG plug-in for Welch Allyn CardioPerfect Workstation as described in this manual.
For other information about the Workstation software please refer to the appropriate
Workstation manuals.
Intended use
The device is specifically intended for the recording of standard 12-lead electrocardiograms.
Please note that the word “device” is used to indicate the Welch Allyn CardioPerfect recording
hardware in combination with the Pocket ECG software.
Indications
Because of the widespread availability and application of the generic kind of device, the user is
assumed knowledgeable enough to determine if use of the device is indicated.
Contraindications
There are no known contraindications for the recording of a resting ECG.
Precautions
Due to summation of leakage currents, it is possibly hazardous to connect several devices to
the patient simultaneously.
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Notations used in the manual
In this manual the following notations are used:
Dialog boxes:
CardioPerfect
Pocket ECG User - Manual
The nam
When referring to check boxes in dialogs, the term “selected” means that a check is
displayed in the check box, and therefore that the option is active.
When referring to a certain button, setting or menu option the text in this control is
displayed in bold.
Stylus:
Tap mea
Tap and hold means point to an item and then press and hold the stylus to the screen.
Drag means to point, press and then hold down while moving the stylus.
Entering data:
Data can be
Keypad:
The keyp
briefly touching it with the stylus.
Handwriting recognition:
Touch the arrow button n
writing mode in the pop-up menu.
es of dialog boxes, windows and tabs are displayed in bold.
n
s to press the stylus to the screen and quickly release.
entered via the keypad or handwritten with the stylus
ad is located on the right in the status bar. You can operate the keypad by
ext to the keypad icon in the status bar and select the desired
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1. Getting started 1. Getting started
1.1 The Pocket ECG window 1.1 The Pocket ECG window
This section will guide you around the various parts of Pocket ECG. By tapping on the Pocket
This section will guide you around the various parts of Pocket ECG. By tapping on the Pocket
ECG icon
ECG icon
can start the Pocket ECG program.
either in the start menu or in the command bar at the bottom of the screen you
Navigation bar
Folder toolbar
Navigation bar
Command bar This ba
File list area The file list area lets you ea
Folder list area In the folder list area the do
Command bar
The top ba
which program is currently active. In addition, the time is also displayed here.
To the left of the time you will find the loudspeaker icon. To the right of it,
depending on the application, you will see an icon closing the application or
confirming entries.
r is lo
bar contains a number of tasks that you can perform with Pocket ECG.
can see all your recorded ECG files and Patient cards, select a file and open
it for review or delete it.
are shown per default in the My Documents folder.
r is called the navigation bar. In the navigation bar you can read
cated at the bottom of the display. Each menu in the command
File List area
sily retrieve patients and tests. In this area, you
cument tree is shown. The ECG and patient files
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Basic principles of Pocket ECG.
In Pocket ECG you are working in one of three main modes, each having different window
layout and control button functionality:
- MONITOR mode
- REVIEW mode
- FILE LIST mode
Monitor mode
Monitor window Monitor during ECG recording
Monitor mode is used to evaluate the quality of traces see average pulse rate and start ECG
Recording. In some cases it can be used for long term monitoring. You may also enter Patient data or change Settings before Recording in this mode.
Review mode
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Review mode allows you to evaluate recorded ECGs, scroll through all recorded segments,
provide measurements, enter or edit Patient data and Texts, listen or add voice comments
or change Settings.
File list mode
File list mode allows you to see all your recorded ECG files and patient files. Select an ECG
file, open it for Review or delete or select a patient file and open it. From here you may
create new files for recording.
The files from the selected folder in the Folder list area are shown in the file list area. In
the picture above the files in the My Documents folder are shown. If Pocket ECG is started
by default the My Documents folder will be opened and any new recordings will be stored in
this folder. To add, rename or delete a file or folder select a folder in the Folder list area
then tap Folder in the Folder toolbar. You can now select New, Rename or Delete.
To enlarge or decrease the size of the File list area you can either tap on the
corresponding arrow symbol in the Folder toolbar, or you can drag the toolbar with
your stylus.
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2. Recording ECGs
2.1 Record an ECG
Pocket ECG records ECGs fast, easily and reliably. The only thing you have to do is make sure
the electrodes are placed correctly and switch on the recorder. Pocket ECG takes care of
recording and saving the recording.
To record an ECG, you need to follow these global steps. Each step is explained in more
detail on the following pages.
1. Place electrodes on the patient (see § 2.2 ).
In Pocket ECG, create a Ne
2.
If there are no recordings for this patient on your Pocket PC start with To create a new test.
If a previous test is available for the patient for whom you want to record an ECG or if a Patient
card is available for this patient, select the (latest) test or the patient card, indicated with
the File list area then continue with To create a new test.
To create a new test:
In the Command ba
If you have selected a patient/file in the File list area, Pocket ECG will ask if you want
to copy the Patient data from the selected file to the new ECG.
If you select Yes the Patient data will be copied into the Patient card for the new test. If
you select No or if no file was selected the Patient card will be empty and has to be
filled in later.
r, tap on the ECG menu and tap New.
w E
CG test.
, in
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3. The Real-time monitor is displayed. Pocket ECG asks you to switch on the recorder. Switch
on the recorder.
4. The Real-time monitor displays the ECG traces and average pulse rate.
5. Select which leads should be displayed and adjust your view on the ECG traces in the ECG
menu (see
§ 2.4 ).
6. Cre
7.
8. In the Real-time monitor
9. When the recording is finished, Pocket ECG will ask you to switch of the recorder. Switch of
10. If you are satisfied with the recording disconnect the patient.
11. You can add interpretations, comments and voice comments. Save the recording by
ate or adjust a Patient Card (see § 2.3 ).
If necessa
(see § 2.5 ).
to start recording. The progress of the recording is shown in the gauge at the bottom of the
window.
the recorder. Pocket ECG automatically saves the ECG and the recorded ECG is
automatically displayed in the Review window.
tapping the OK button. If not previously filled in the Pocket ECG will now ask for a User
name and e-mail address to sign the ECG file.
ry, apply a Notch filter to remove possible noise due to AC mains interference
, wait until the signal is stabilized and, tap the
Record button
2.2 Place electrodes on the patient
Important: Because Pocket ECG is a 12 lead electrocardiograph all electrodes must be
connected! Proper skin preparation (abrasion if necessary) and pro per electrodes are very
important for a good signal quality.
Important: When you connect the electrodes to the patient, make sure that the electrodes and
their connectors (also the RL/N electrode) do not contact other conducting parts (including
earth).
Extremity electrodes
When you record a Resting-ECG, the extremity electrodes should be connected to the ankles
and wrists.
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