DigiTrak XT Recorder
INSTRUCTIONS FOR USE
Notices
453564064111
January 2008
Edition 1
Printed in the USA
Applicable to Model 860322
Philips Medical Systems shall not be
liable for errors contained herein or for
incidental or consequential damages in
connection with the furnishing,
performance, or use of this material. This
information is subject to change without
notice.
Copyright
Copyright © 2008 Philips Electronics
North America Corp.
Philips Medical Systems
3000 Minuteman Rd.
Andover, MA 01810 USA
TEL: (978) 687-1501
CAUTION
THIS PRODUCT IS NOT INTENDED
FOR HOME USE. IN THE U.S.,
FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE ON OR BY THE
ORDER OF A PHYSICIAN.
Trademarks
Windows is a registered trademark of
Microsoft Corporation.
All other brand and product names are
trademarks or registered trademarks of
their respective companies.
Warranty
This Philips product is warranted against
defects in materials and workmanship for
a period of two years from the date of
shipment. During the warranty, Philips
will, at its option, either repair or replace
products which prove to be defective.
Philips does not warrant that the operation
of this software, firmware, or hardware
shall be uninterrupted or error free.
No other warranty is expressed or
implied. Philips specifically disclaims the
implied warranties of merchantability and
fitness for a particular purpose other than
described herein.
Philips considers itself responsible for
effects on safety, reliability, and
performance only if:
– Assembly operations, extensions,
readjustments, modifications and
repairs are carried out by Philips
authorized personnel only.
– Electrical installation in the relevant
room complies with applicable
requirements.
– Equipment is used in accordance with
the instructions for use.
Limitations of Warranty
The foregoing warranty shall not apply to
defects resulting from:
– Improper or inadequate maintenance
by buyer.
– Buyer-supplied software or interfacing.
– Unauthorized modification or misuse.
– Operation outside of the environmental
specifications for the product.
– Improper site preparation.
– Improper maintenance.
Excluded from this warranty are
expendable supply items including, but
not limited to, electrodes, lead wires,
patient cables, and battery. This warranty
does not apply to any product that Philips
Medical Systems determines has been
modified or damaged by the customer.
Service Agreements
Periodic inspections and maintenance
service are recommended to ensure
effective operation. Call your Philips
Sales and Service Office for details
regarding a Customer Support Services
Agreement for your specific requirements.
Global Medical Device
Nomenclature (GMDN)
The 5-digit GMDN code adjacent to the
symbol is defined in the EN ISO 15225.
Unpacking and Storage
The equipment is packed in its own
reusable shipping container. When
unpacking the equipment, inspect the
carton for physical damage. Any damage
should be reported immediately to the
shipping company. Open the shipping
container and compare the contents to the
packing list. There is only one packing list
per shipment. If there are several parcels,
the shipping list is normally attached to
the largest container. If the packing list
does not agree with the items received,
contact a Philips Response Center. The
shipping container should be saved to
permit reshipment.
Medical Device Directive
DigiTrak XT, model 860322
with the requirements of the Medical
Device Directive 93/42/EEC and carries
the
Authorized EU-representative:
Philips Medizin Systeme
Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen
Germany
mark accordingly.
0123
complies
Table of Contents
Safety and Warning Information
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v
Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Materials Used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-vii
Security Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Chapter 1. Using the DigiTrak XT Recorder
System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Using the DigiTrak XT with Legacy Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Accessing Documentation Updates at InCenter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Accessing Documentation at the Philips Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Getting Acquainted with the DigiTrak XT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
About Recorder Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Navigating the Recorder Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Using the Belt Clip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Setting the Recorder Date and Time (First Time Use only) . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Step One — Connecting the Recorder to the Dual Dock . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Step Two — Entering the Patient’s Name (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Step Three — Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Step Four — Checking the Lead Status and ECG Signal Quality . . . . . . . . . . . . . . . . . . . 1-14
During a Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Step Five — Removing and Shutting Down the Recorder . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Step Six — Downloading Data from the Recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Changing Recorder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Saving Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Pacemaker Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Pacemaker Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Adjusting Pacemaker Thresholds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Registering an Event (Patient Event Marker) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Stopping a Recording (Early Out) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Deleting Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
DigiTrak XT Instructions for Use iii
Table of Contents
Chapter 2. Service and Specifications
Service & Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Calling for Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Supplies & Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Replacing the Battery Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Appendix A.
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
Index
iv DigiTrak XT Instructions for Use
1Safety and Warning Information
The DigiTrak XT Holter Monitor is a battery operated solid state recorder, designed for up to
168 hours (7 days) continuous recording of ambulatory electrocardiograph (AECG) data. It
has the ability to detect and record pacemaker pulses according to the appropriate criteria for
AAMI pacer detection.
The DigiTrak XT is an AAMI Type I device and part of a conventional AECG monitoring
system where an ECG is recorded in Multi Media Card (MMC) memory within the recorder.
After the recording is complete, the DigiTrak XT recorder is connected via the docking station
to a USB port on the Holter computer. Follow the instructions provided with the Holter
application to download and analyze the recorded ECG data.
Indications for Use
The DigiTrak XT Holter recorder is intended for patients requiring ambulatory (Holter)
monitoring.
CAUTION The DigiTrak XT recorder is not intended for use on infants weighing under 10 kilograms
(22 pounds), as required by IEC 60601-2-47:2001.
Such monitoring is most frequently used for the indications below:
Evaluation of symptoms suggesting arrhythmia or myocardial ischemia
Evaluation of ECG documenting therapeutic interventions in individual patients or groups
of patients
Evaluation of patients for ST segment changes
Evaluation of a patient's response after resuming occupational or recreational activities
(for example, after myocardial infarction or cardiac surgery)
Clinical and epidemiological research studies
Evaluation of patients with pacemakers
Reporting of time and frequency domain heart rate variability
Reporting of QT interval
v
Safety and Warning Information
Equipment Symbols
Symbol Meaning
0123
Attention: Consult accompanying documents
Symbol on label indicates Philips meets the applicable requirements
of the European directive 93/42/EEC
Type B equipment contains adequate protection against electrical
shock, particularly regarding the allowable leakage current and the
reliability of protective earth connection (when present)
Dispose of in accordance with the requirements of your country.
SN
REF
Date of manufacture
2000
China ROHS
Serial number
Not shown - catalogue number is DigiTrak XT
The 5-digit Global Medical Device Nomenclature (GMDN) code
adjacent to the symbol is defined in the EN ISO 15225.
vi DigiTrak XT Recorder Instructions for Use
Precautions
Patient leads must be removed from electrodes before defibrillation.
When using Pacer Detect, be aware that false positive and false negative pacer detects
may occur.
– False positives — may result from poor electrode hookup or high noise conditions.
– False negatives — may occur with bipolar pacers due to a weak pacer pulse signal at
The presence of pacemaker signals in the ECG trace should not be considered true
representations of the actual pacemaker stimulus amplitude when viewing the ECG data.
Observe local laws for disposal of alkaline and lithium batteries.
Do not leave the battery in the recorder when it is not in use. Damage from corrosion
could result.
Use of rechargable batteries is not recommended.
For the best recording results, the patient should be instructed to avoid close proximity to
heavy electrical equipment or other sources of electromagnetic interference such as
electric blankets, heating pads, etc.
Precautions
the patient's skin surface.
The DigiTrak XT recorder should not be immersed in water. The patient should be
instructed not to wear the recorder in the shower or bath.
The DigiTrak XT recorder supports an Early Out feature that allows a trained individual to
stop a recording before the selected recording time has elapsed. Failure to follow this
procedure may result in the loss of all recorded ECG data.
This product consists of devices that may contain mercury, which must be recycled or
disposed of in accordance with local, state, or federal laws. Within this system, the
backlight lamps in the monitor display contain mercury.
Electrode Application
It is recommended that trained medical personnel handle the application of electrodes.
Use only electrodes designed for longer term Holter monitoring.
Proper preparation of the patient's skin is absolutely essential for obtaining a quality ECG
recording. Refer to your electrode provider or this guide for instructions on skin
preparation techniques.
Apply electrodes as shown in the diagrams of the Monitor Hookup Kits, the Electrode
Placement diagrams in this guide, or as instructed by a physician.
Materials Used
The DigiTrak XT recorder, belt clip, and patient cable do not contain any latex material.
DigiTrak XT Recorder Instructions for Use vii
Safety and Warning Information
Security Recommendations
To further strengthen the security and confidentiality of your patient records and system in
general, we recommend that you implement additional security measures, including:
Remind your patients that the recorder contains confidential patient data and they should
safeguard the recorder while it is in their possession.
Store the recorders in a secure location when not in use.
Delete patient data from the recorder after it has been downloaded to Holter. (See
“Deleting Patient Information” on page 1-19 for instructions.)
Conventions
This book uses the following text conventions:
WARNING Warning statements describe conditions or actions that can result in personal injury or
loss of life.
CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss
of data. Caution statements alert the user that the clinician has the responsibility of determining
significance of results due to actions and varying factors present with each case.
NOTE Notes contain additional information on using this product.
viii DigiTrak XT Recorder Instructions for Use
1
Chapter 1Using the DigiTrak XT Recorder
The DigiTrak XT Holter Monitor is a battery operated solid state recorder, designed for up to
168 hour (7 day) continuous recording of ambulatory electrocardiograph (AECG) data. It has
the ability to detect and record pacemaker pulses according to the appropriate criteria for
AAMI pacer detection.
Features include:
Multi-day recording, up to 168 hours (7 days)
Easy navigation of user menus
Streamlined form factor and light weight for patient comfort
Workflow enhancements, featuring the ability to preprogram user demographics
information, on-screen lead status and gain adjustment
Reliability improvements, featuring a reinforced patient cable connector and power-on
self tests to check for battery life
Supportability enhancements, featuring easy removal and replacement procedures
Security enhancements, featuring soft encryption of data. Encryption is the conversion of
data into a form that cannot be understood by unauthorized people. Decrypting is the
process of converting encrypted data back into its original form so that it can be
understood.
This chapter provides the following information:
System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Using the DigiTrak XT with Legacy Software . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Accessing Documentation Updates at InCenter . . . . . . . . . . . . . . . . . . . . . . . .1-3
Accessing Documentation at the Philips Website. . . . . . . . . . . . . . . . . . . . . . .1-3
Getting Acquainted with the DigiTrak XT . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Back View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
About Recorder Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Navigating the Recorder Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
Using the Belt Clip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
Setting the Recorder Date and Time (First Time Use only). . . . . . . . . . . .1-8
Step One — Connecting the Recorder to the Dual Dock. . . . . . . . . . . . . .1-9
Step Two — Entering the Patient’s Name (Optional) . . . . . . . . . . . . . . .1-11
Step Three — Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
1-1
Using the DigiTrak XT Recorder
Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
Step Four — Checking the Lead Status and ECG Signal Quality . . . . . .1-14
During a Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Step Five — Removing and Shutting Down the Recorder. . . . . . . . . . . .1-16
Step Six — Downloading Data from the Recorder . . . . . . . . . . . . . . . . .1-16
Changing Recorder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Saving Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Pacemaker Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Pacemaker Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Adjusting Pacemaker Thresholds. . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Registering an Event (Patient Event Marker) . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Stopping a Recording (Early Out). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
Deleting Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
System Requirements
Your Holter software must be at Version 2.9 or later in order to perform multi day scans
greater than 48 hours. See the Philips Holter Installation and Configuration Guide or the
Philips Holter Instructions for Use for a complete list of system requirements.
Using the DigiTrak XT with Legacy Software
You must install the DigiTrak XT Compatibility software to use the DigiTrak XT with Holter
releases 2.7, 2.8, and 2.8.1. See the DigiTrak XT Compatibility Software Installation
Instructions that came with the DigiTrak XT CD for more information.
1-2 DigiTrak XT Recorder Instructions for Use
Accessing Documentation Updates at InCenter
Accessing Documentation Updates at InCenter
Updates to the documentation are provided periodically. To access the latest documentation,
visit the Philips InCenter website, at
https://incenter.medical.philips.com/default.aspx.
If you do not yet have an InCenter user ID, register by clicking the link
software updates and documentation for cardiology products”
ID and password will be sent to the email address you provide, enabling access to
documentation updates, as well as free software updates, when available.
on the right side of the page. A user
“Click here for access to
Accessing Documentation at the Philips Website
Documentation for many Philips medical products can be downloaded from the Philips
website, at
www.medical.philips.com/goto/productdocumentation.
DigiTrak XT Recorder Instructions for Use 1-3
Using the DigiTrak XT Recorder
Getting Acquainted with the DigiTrak XT
The DigiTrak XT’s buttons and connections are carefully organized to facilitate ease of use.
Front View
A
H
G
Reference Letter Description
B
C
D
E
F
A Belt clip
B Recorder screen
C Up arrow
D Enter, Event button
E Down arrow
F Right arrow
G Left arrow
H Patient cable
1-4 DigiTrak XT Recorder Instructions for Use
Back View
Getting Acquainted with the DigiTrak XT
A
H
B
G
C
F
D
E
Reference Letter Description
A Battery door
B Battery compartment
C Model number
D Recorder configuration label
E Patient cable
FService tag
G Serial number
H Recorder tether slot
DigiTrak XT Recorder Instructions for Use 1-5
Using the DigiTrak XT Recorder
About Recorder Functions
The following table describes the recorder screens and menus.
Table 1-1 DigiTrak XT recorder functions
Screen Description
Lead Status Displays the connection status of each lead.
CH1, CH2, CH3 Displays the signal trace in real time with pacer pulse marks, if
selected. There is one screen for each ECG channel.
The gain setting is the same for all channels and is displayed in
the lower right corner of the screen.
If Pacer Detector is on, the pacer pulse marks are displayed
below the trace to indicate each pacer pulse detection and you
can adjust the threshold for pacemaker spike detection.
Settings Determines the following recorder settings:
Record Time – 24, 48, 72, 96, 168 hr
Pacer Detector – ON or OFF. (The default for pacer detect is OFF.
It must be turned
ON for each procedure in which it will be used
or saved as part of the default settings.)
Language – English, Spanish, German, French, Italian, Portuguese,
Swedish, Dutch
Contrast – 20- 95%
Sample Rate – 175 s/s
Resolution – 10 bit
Save as Default – Yes or No. The default for saving settings is
No. Yes
saves the current configuration (including date and time
settings) as the default.
Date/Time Set the following date and time options:
Month, Day, Year
Date Format – MM/DD/YYYY, YYYY/MM/DD, DD/MM/YYYY,
YYYY/DD/MM
Hour and Minute
Auto DST – ON or OFF. Daylight savings time uses the United
States convention.
Time Format – 12 or 24 hr
1-6 DigiTrak XT Recorder Instructions for Use
Table 1-1 DigiTrak XT recorder functions (continued)
Screen Description
About Displays the following information about the recorder:
Product name
Serial number
Firmware version information
Start After configuring or reviewing all the settings, select the start screen
and press
Enter.
This will start the recording. During recording, the recorder displays
the current time and time remaining to record.
Navigating the Recorder Display
Use the following buttons to navigate the DigiTrak XT screens:
Navigating the Recorder Display
Button Description
Left arrow. Moves from one tab to the next
and changes values within a field.
Right arrow. Moves from one tab to the next
and changes values within a field.
Down arrow. Moves from one field to the
next.
Up arrow. Moves from one field to the next.
Enter. Used to change settings and to save the
current settings.
Event marker. Used by the patient to record
events.
If scroll arrows appear on the display, it indicates additional fields that are located off the
screen. Use the up and down arrow keys to access these additional fields.
DigiTrak XT Recorder Instructions for Use 1-7
Using the DigiTrak XT Recorder
Using the Belt Clip
To insert the recorder into the belt clip
Slide the belt clip over the battery end of the recorder until it snaps into place.
1
2 Rotate the belt clip until it locks into the desired position.
To remove the recorder from the belt clip
X Slide the battery end of the recorder out of the belt clip.
Getting Started
The following sections describe how to set up the recorder for use.
NOTE If the recorder is turned off for any reason, for example, to shut it down early, you must remove the
battery. To restart the recorder, insert the battery and press Enter. When the recorder is powered
on, default settings are in effect; any custom settings are lost. In addition, the previous ECG recording
is erased.
Setting the Recorder Date and Time (First Time Use only)
To set the recorder date and time
NOTE Use an alkaline battery for recordings up to 96 hours. Use a lithium battery for recordings over 96
hours.
1
Make sure a fresh AAA battery is in the recorder.
NOTE The recorder enters sleep mode after 20 seconds of no activity. If this happens, simply press Enter
to turn the recorder on.
2
Use the arrow buttons to display the Date/Time tab.
3 Press Enter.
4 Use the up and down arrows to select the parameter to change (hour, minute, date, and so
on), and use the
5 Press Enter to accept the changes.
6 To start a recording, display the Start tab and then press Enter to begin recording.
7 If you do not want to start a recording, remove the battery to shut down the recorder.
left and right arrows to change the setting of the parameter.
1-8 DigiTrak XT Recorder Instructions for Use
Getting Started
Step One — Connecting the Recorder to the Dual Dock
You connect the recorder to the docking station to enter patient information and to download
data collected in the DigiTrak XT recorder to the Holter application. The data is transferred to
and from the Holter system via a USB docking station. The docking station is connected to the
PC through a USB port; you place the recorder in the docking station to transfer the data. The
dual dock refers to the docking station that accommodates both the DigiTrak XT and DigiTrak
Plus recorders.
Ensure the dual dock is connected to the Holter computer before proceeding.
To connect the dual dock to the Holter computer
X Plug the USB connector from the dual dock into an available USB port on the computer.
To connect the recorder to the dual dock
Remove the battery from the recorder.
1
2 Remove the belt clip or pouch from the recorder, if attached.
CAUTION Do not insert the recorder at a high angle or with the pins facing out. Inserting the recorder from a
high angle will result in bent pins.
3 Gently slide the left side of the recorder straight into the dual dock station (at the angle
shown) with the pins facing the side (under the flap). The recorder snaps into place.
4 Gently press down on the right side of the recorder to lock it into the dual dock station.
There should be light resistance.
DigiTrak XT Recorder Instructions for Use 1-9
Using the DigiTrak XT Recorder
CAUTION Do not force the recorder into the dual dock. If it does not easily snap into place, remove the
recorder and try installing it again.
USB connected appears on the recorder display when the recorder is properly connected
and the
Preloading message appears in the bottom right of the Holter application window
(if there is data on the recorder). The dual dock is now operational and you are ready to
enter or download data.
1-10 DigiTrak XT Recorder Instructions for Use
Getting Started
Step Two — Entering the Patient’s Name (Optional)
To enter patient information
With the dual dock connected to the PC, insert the recorder into the dual dock.
1
2 Launch the Holter program.
3 Click Tools > Recorder Utility.
The Recorder Utility screen appears.
4 Select Philips Recorders as the type.
5 Enter the patient information (last name, first name, ID, and so on).
6 Click Write to Philips Recorders.
After several seconds the data is written to the recorder.
NOTE All patient information is displayed on the recorder if you entered it using the Holter 2.9 software.
Although previous versions of software store the patient information and display it on the report, only
the patient name is displayed on the recorder screen.
7
Remove the recorder from the dual dock.
DigiTrak XT Recorder Instructions for Use 1-11
Using the DigiTrak XT Recorder
Step Three — Preparing the Patient
Before You Begin
Insert a fresh AAA battery with each patient. Be sure to observe the correct battery
polarity.
Instruct the patient not to tamper with the recorder, remove the battery, or disconnect the
patient cable.
To prepare the patient
Prepare the patient’s skin prior to applying the electrodes. Skin is a poor conductor of
1
electricity, so skin preparation is important in achieving good electrode-to-skin contact.
– If necessary, clip hair at the electrode sites (or shave sites, if needed).
– Clean and abrade the skin at the electrode site. Wash skin thoroughly with soap and
water.
– Dry the electrode sites briskly to increase capillary blood flow in the tissues and to
remove oil and skin cells.
2 Attach the leads to the electrodes before placing them on the patient.
3 Apply the electrodes by peeling them, one at a time, from the protective backing and
sticking them firmly to the patient’s skin. (Refer to Figure 1-1 for proper electrode
placement.) Press around the entire edge of each electrode to ensure they are secure. Make
sure the lead wires do not pull on the electrodes.
1-12 DigiTrak XT Recorder Instructions for Use
Figure 1-1 Electrode Placement
Getting Started
Red (-)
White (-)
Brown (+)
CAUTION Lead colors for EASI Holter hookups are different from those used for EASI telemetry hookups. Lead
placements are the same.
Electrode Placement
Green
Black (+)
E (Brown) Level of 5th intercostal space, midsternum
A (Black) Same level as E and I, left mid-axillary line
S (Red) Top of sternum (manubrium)
I (White) Same level as E and A, right mid-axillary line
Ground (Green) Center of sternum or any convenient location
Raw Channel Description
Channel 1 E (+) to S (-)
Similar to MC V1, anterior view of the heart
Channel 2 A (+) to S (-)
Similar to MC V6, a lateral view of the heart -- useful for ST
measurements
Channel 3 A (+) to I (-)
CC6, similar to the inferior lead aVF – approximation suitable for ST
measurements
DigiTrak XT Recorder Instructions for Use 1-13
Using the DigiTrak XT Recorder
Step Four — Checking the Lead Status and ECG Signal
Quality
To check the lead status
Make sure a fresh AAA battery is in the recorder.
1
The recorder turns on as soon as you put in a battery. The recorder performs a self-test and
the splash screen appears for a couple of seconds, with the message
displayed at the bottom of the screen. If the cable is not connected, the message No Cable
appears at the bottom of the screen and you cannot proceed.
2 Insert the patient cable (lead set) into the recorder connector. Press firmly to be sure it is
seated properly.
3 Press any button to enter the menus.
Press any key to start
If you entered patient information, it is displayed. Otherwise, the
NOTE All patient information is displayed on the recorder if you entered it using the Holter 2.9 software.
Although previous versions of software store the patient information and display it on the report, only
the patient name is displayed on the recorder screen.
4
Use the arrow buttons to select the Lead Status tab.
5 Check the diagram for loose connections.
Leads Status tab appears.
– indicates a lead has a good patient connection
– (flashing) indicates a lead does not have a good patient connection
–
Leads OK or Leads Error message displayed
6 Use the arrow buttons to select the CH1, CH2, and CH3 tabs and check the ECG signal
quality.
1-14 DigiTrak XT Recorder Instructions for Use
7 Observe the screen for cable and lead errors as follows.
8 When all the leads are properly connected, the ECG waveform appears.
9 Use the arrow buttons to change the gains settings of the display, as shown in the
following table.
NOTE The recording for all resolutions is always made at the 1X gain setting.
Getting Started
Table 1-2 Gain Settings
Gain on screen Millivolt range
0.5X ± 5 peak-to-peak
1X ± 2.5 peak-to-peak
2X ± 1.25 peak-to-peak
10
Proceed to Settings and select Pacer Detector, if applicable.
11 Use the arrow buttons to select the Start tab and press Enter to start the recording.
NOTE If you do not start the recording, the DigiTrak XT automatically starts recording after 30 minutes,
provided there are no lead errors.
During a Recording
During a recording, the DigiTrak XT displays the date, current time, and the time remaining
for the recording as well as any lead or cable error, if present.
DigiTrak XT Recorder Instructions for Use 1-15
Using the DigiTrak XT Recorder
Step Five — Removing and Shutting Down the Recorder
To retrieve the recorder
1
When the patient returns, remove the recorder from the patient.
The recorder automatically shuts down after the record time you set has expired. To shut
down the recorder before the specified time expires, see “Stopping a Recording (Early
Out)” on page 1-19.
2 Remove the patient cable.
If you pre-loaded the patient information, the patient name appears on the recorder screen
until you download the data.
Step Six — Downloading Data from the Recorder
To download data from the recorder into the Holter system
Launch the Holter application.
1
2 Connect the recorder to the Holter system as described on page 1-9. Be sure to remove the
battery from the recorder.
The text
Preloading appears in the lower right-hand corner of the PC screen.
CAUTION Do not disconnect the recorder whenever the Preloading message is flashing. To cancel the
Preloading sequence, double-click the Preloading message and select Abort.
If you accidentally unplug the recorder during a preload sequence, restart the PC to clear the
DigiTrak XT device. If the recorder is unplugged prematurely, the ECG is corrupted.
3 Leave the recorder connected until downloading of the data is complete.
You can perform an analysis while downloading data.
4 When downloading of the data is complete, detach the recorder from the dual dock, then
scan and save the ECG.
5 Repeat steps 1-3 for subsequent new patients.
6 Refer to the Philips Holter Instructions for Use for information on performing a scan.
1-16 DigiTrak XT Recorder Instructions for Use
Changing Recorder Settings
You can change various recorder settings (specified in Table 1-1) and save them (along with
the date and time settings) as the default through the
To change recorder settings
1
Select the Settings tab.
2 Change the settings, as necessary.
3 Select OK and press Enter to save the settings.
Saving Default Settings
To save the settings as the recorder default settings
1
Change the settings, as necessary. Change the date and time settings as necessary (located
on the
Date/Time tab).
2 Select Save as default (located on the Settings tab) and press Enter to save the settings.
Changing Recorder Settings
Settings tab.
Pacemaker Detection
Pacemaker detection for the DigiTrak XT recorder is automatically defaulted to OFF. You
must turn it On for each procedure in which it is used or save the setting as part of the default
settings.
Pacemaker Threshold
The DigiTrak XT recorder allows the user to adjust the threshold for pacemaker spike
detection. The purpose of this feature is to raise or lower the threshold of the recorder
detection in order to eliminate spikes from a rate-modulated pacemaker or lower the threshold
to allow for better detection of bipolar pacemakers.
NOTE Adjusting the threshold on the DigiTrak XT recorder does NOT affect any threshold settings on the
patient’s pacemaker. The adjusting of the threshold settings are confined totally to the function of the
recorder.
You do not have to adjust the pacemaker recording threshold for all recordings.
Adjusting Pacemaker Thresholds
To adjust a pacemaker threshold
Select the Settings tab.
1
2 Ensure that the Pacer Detector setting is ON.
3 While viewing the ECG waveform, press Enter to display the pacemaker threshold
indicator on the right side of the screen.
The top position of the bar indicates maximum sensitivity. The indicator defaults to one
below the maximum sensitivity.
DigiTrak XT Recorder Instructions for Use 1-17
Using the DigiTrak XT Recorder
NOTE The Enter button toggles between the pacemaker threshold indicator and the gain setting.
4
Check to see if there are pacer pulses in the pacer detection channel on the bottom of the
screen.
5 If there are many pacer pulses in the pacer detection channel and less or none in the ECG
channel, reduce the sensitivity of the pacemaker threshold indicator.
6 If there are no pacer pulses in the pacer detection channel and there are pacer pulses in the
ECG channel, increase the sensitivity of the pacemaker threshold indicator.
7 Use the arrow buttons to select the Start tab and press Enter to start the recording when you
are satisfied that the correct pacer pulses are being detected.
Registering an Event (Patient Event Marker)
The DigiTrak XT allows an easy way for the patient to record events. Once an event has been
marked, the patient must wait one minute to register another event.
To register an event
X Press Enter each time to mark an event.
The marked event time stamp appears on the recorder screen. After 20 seconds have
elapsed, the time stamp is cleared from the recorder screen.
1-18 DigiTrak XT Recorder Instructions for Use
Stopping a Recording (Early Out)
The recorder supports an Early Out feature that allows a trained individual to stop a recording
before the selected recording time has elapsed.
To stop a recording in progress
1
Hold the left arrow and Enter buttons simultaneously.
A menu is displayed with the choices Stop Recording or Exit Menu.
2 Select Stop Recording and press Enter.
The messages,
Shutting down please wait. Recording complete appear, the recording stops and
the recorder shuts down.
3 If you do not want to shut down the recorder, select Exit Menu.
The recorder status screen appears and the recording continues.
Deleting Patient Information
Stopping a Recording (Early Out)
Patient information (including ECG data) is erased from the recorder the next time you turn on
the recorder. Once you press a key to enter the recorder’s menus, the message
Initializing Card
briefly appears on the screen. When this occurs, the MMC card is erased and any previous
patient and ECG information is deleted from the recorder.
If you are storing the recorder after downloading data, you can use the following procedure to
erase the patient data.
To delete patient information
Remove the battery from the recorder.
1
2 Insert a battery into the recorder.
The recorder turns on as soon as you put in a battery. The recorder performs a self-test and
the splash screen appears for a couple of seconds, with the message
Press any key to start
displayed at the bottom of the screen. If the cable is not connected, the message No Cable
appears at the bottom of the screen and you cannot proceed.
3 Insert the patient cable (lead set) into the recorder connector. Be sure it is seated properly.
4 Press Enter.
The message
Initializing Card briefly appears on the screen. When this occurs, the MMC
card is erased and any previous patient and ECG information is deleted from the recorder.
DigiTrak XT Recorder Instructions for Use 1-19
Chapter 1Service and Specifications
This chapter provides information about servicing your recorder, device specifications, and
available parts and accessories.
Service & Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Calling for Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Supplies & Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Replacing the Battery Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Service & Maintenance
2
Cleaning
To clean the recorder
Remove the battery from the recorder.
1
2 Dampen a soft cloth with a mild detergent and water mixture.
3 Clean the recorder, lead wires, and belt clip.
4 Remove any adhesives from the patient lead wires with an adhesive tape remover solution
or swab with mild detergent.
CAUTION Do not use alcohol or acetone to clean the lead wires as this can cause the wires to stiffen and the
insulating plastic to crack. Do not immerse the recorder in water.
2-1
Service and Specifications
Troubleshooting
If you are having problems with the recorder, refer to the table below first. If your issue is not
addressed, call the Response Center.
Table 2-1 Troubleshooting
Symptom Solution
No display or Recorder does
not power on
Low battery
Self Test Error 52. Stuck Key.
Reboot.
message
Battery does not last 24 or 48
hours
Battery does not last 96 or 168
hours.
Recorder does not run as long
as expected
Ensure that any previous ECG recording has been
downloaded to the Holter application.
Ensure battery is inserted with correct polarity.
Install a new 1.5V AAA battery.
Ensure patient cable (lead set) is connected and press
Enter.
Install a new battery.
Inspect battery compartment, clean contacts if
necessary.
Can be caused by pressing a key when inserting the
battery. Try reinserting the battery, making sure you
are not pressing any of the recorder keys. If the
message persists, call for service
Ensure a new alkaline battery is being used. Do not
use rechargeable batteries.
Ensure a new lithium battery is being used. Do not use
rechargeable batteries.
Check the Record time in the Settings screen.
Ensure a fresh alkaline battery is being used for 24 or
48 hour recordings.
Ensure a fresh lithium battery is being used for 96 or
168 hour recordings.
No Cable Ensure patient cable (lead set) is connected to the
2-2 DigiTrak XT Recorder Instructions for Use
recorder. The recorder will not pass the splash screen
unless a cable is connected.
Check that the recorder pins are not broken or bent.
Check that the cable connector is not damaged.
Troubleshooting
Table 2-1 Troubleshooting (continued)
Symptom Solution
Noise artifacts on ECG signal Ensure you have prepared the patient’s skin according
to the instructions on page 1-12.
Ensure the electrodes are properly applied to the
patient.
Ensure the leads are making proper contact with the
electrodes.
Ensure patient cable (lead set) is making contact with
the electrodes.
Replace the lead set.
No Lead Connected message Ensure you have prepared the patient’s skin according
to the instructions on page 1-12.
Ensure the electrodes are properly applied to the
patient.
Ensure the leads are making proper contact with the
electrodes.
Ensure patient cable (lead set) is connected.
Replace the lead set.
Leads Error
Ensure you have prepared the patient’s skin according
to the instructions on page 1-12.
Ensure the electrodes are properly applied to the
patient.
Ensure the leads are making proper contact with the
electrodes.
Ensure patient cable (lead set) is connected.
Replace the lead set.
Defective Card message Remove and reinsert battery. Note that when you
restart the recorder, all patient and ECG information is
erased from the memory card and cannot be recovered.
If message still appears, call for service.
Existing ECG in recorder. The
Download the ECG data to the Holter application.
patient’s name is displayed on
the recorder screen. The
recorder does not power on.
Self test failure
Write down the error code.
Restart the recorder.
Call for service.
DigiTrak XT Recorder Instructions for Use 2-3
Service and Specifications
Table 2-1 Troubleshooting (continued)
Symptom Solution
No splash screen when
recorder is placed in dual dock
Calling for Service
For telephone assistance, call the Response Center nearest to you or visit the website at
www.medical.philips.com/main/services/response_center
Be prepared to provide the following information:
Model number
Serial number
Service tag number
Call customer support before returning a recorder to make shipping arrangements.
Ensure that the DigiTrak XT cable or dual dock cable
is firmly connected to a USB port on the PC.
Ensure that the PC is powered on.
Replace the DigiTrak XT cable or dual dock.
Remove battery from the recorder before placing it in
the dual dock.
North America Response Centers
Country Telephone Number
Canada (800) 323 2280
Mexico 01 800 710 8128
Puerto Rico 1 787 754 6811
United States (800) 722 9377
South America Response Centers
Country Telephone Number
Argentina 54 11 4546 7698
Brazil 0800 701 7789
Chile 0800 22 3003
Columbia 01 8000 11 10 10
Peru 51 1 620 6440
2-4 DigiTrak XT Recorder Instructions for Use
Europe Response Centers
Country Telephone Number
Austria 43 1 60101 820
Belgium 32 2 525 7102 (French)
32 2 525 7103 (Flemish)
Calling for Service
Czech Republic
31 40 2781619
MCR Response Center
(located in The Netherlands)
Denmark 45 80 30 30 35
Finland 358 615 80 400
France 0 810 835 624
Germany 0180 5 47 5000
Greece
31 40 2781619
MCR Response Center
(located in The Netherlands)
Hungary
31 40 2781619
MCR Response Center
(located in The Netherlands)
Italy 0800 232100
Netherlands 31 40 27 211 27
Norway 47 800 84 080
Poland
31 40 2781619
MCR Response Center
(located in The Netherlands)
Rumania
31 40 2781619
MCR Response Center
(located in The Netherlands)
Russia
31 40 2781619
MCR Response Center
(located in The Netherlands)
Slovak Republic
31 40 2781619
MCR Response Center
(located in The Netherlands)
Spain 34 90 230 4050
DigiTrak XT Recorder Instructions for Use 2-5
Service and Specifications
Europe Response Centers (continued)
Country Telephone Number
Sweden 46 200 81 00 10
Switzerland 0800 80 3000 (German)
United Kingdom 44 0870 532 9741
Asia Response Centers
Country Telephone Number
Australia 1800 251 400
China 800 810 0038
Hong Kong 852 2876 7578
0800 80 3001 (French)
Fax: 44 01737 23 0550
India 1600 112 444
Indonesia 62 21 7910040, ext 8610
Japan 81 0120 095 205
Korea 82 02 3445 9010
Malaysia 1800 886 188
New Zealand 0800 251 400
Philippines 63 2 8162617 ext. 875
Singapore 1800 Philips
Taiwan 0800 005 616
Thailand 02 614 3569
Africa and Middle East
Country Telephone Number
All countries
31 40 2781619
MCR Response Center
(located in The Netherlands)
2-6 DigiTrak XT Recorder Instructions for Use
Supplies & Parts
Approved supplies and parts for the DigiTrak XT are listed in the following tables.
To order supplies:
In the USA, call 1-800-227-7843.
Outside the USA, contact your local Philips Medical Systems Sales Office, your
authorized Philips Medical Systems Dealer or Distributor, or visit our website at
http://shop.medical.philips.com
Description Philips P/N
Solid Gel ECG Electrode, 5/pouch M4612A
Adult Plastic Tape ECG electrode, disposable 13942E
DigiTrak XT pouch 989803153451
NOTE For better protection of the recorder, we strongly recommend using the DTXT pouch (part #
989803153451 ). The pouch provides extra protection and cushioning.
Supplies & Parts
The following part can be ordered by contacting the Response Center.
Description Philips P/N
Battery door 453564067201
DigiTrak XT Recorder Instructions for Use 2-7
Service and Specifications
The following parts can be ordered by contacting your local Philips Medical Systems Sales
Office or your authorized Philips Medical Systems Dealer or Distributor.
Description Philips P/N
USB Dual Dock 989803157511
Patient diaries (200) M4701A
24-inch patient cable (lead set) 989803157481
36-inch patient cable (lead set) 989803157491
54-inch patient cable (lead set) 989803157501
DigiTrak XT hookup kit (1 patient diary, 1
M3730-62600
alkaline AAA battery, 1 alkaline AA battery, 5
electrodes)
Patient electrodes (300) M4706A
Belt clip 989803158191
Belt clip (10-pack) 989803158210
Replacing the Battery Door
To replace a broken battery door
Cut the rubber tether on the battery door.
1
2 Remove any tether pieces from the recorder.
3 Insert the tether of the new battery door through the recorder tether slot. Make sure the
small hook at the end of the tether pops out from underneath the recorder tether slot.
Recorder tether slot
4 With the battery door fully closed, slide the door to release the locking mechanism.
5 Lift the battery door at it’s widest point.
When installed correctly, the battery door automatically pivots about the tether. The
battery door will hang off the end of the recorder.
2-8 DigiTrak XT Recorder Instructions for Use
Specifications
Functional
Channels 3
Recorded amplitude resolution 10 bits
Recording Full disclosure
Download interface USB
Sample rate 175/sec maximum
Frequency response 0.05Hz to 60Hz, @-3dB
Signal verification LCD display
Event switch Press Enter
Pacemaker Detection Programmable on/off
Memory
Specifications
Capacity/Recording time 256 MB up to 96 hours
512 MB up to 168 hours (7 days)
Recording type MMC
Physical
Dimensions 91.44 x 55.88 x 19.05mm
(3.60 x 2.20 x 0.75inches)
Weight with battery 70 g. (2.5 oz.)
Enclosure Molded plastic (UL 94V-2)
Operating position Any orientation
Electrical
Gain setting 0.5X, 1X, 2X
Connector 11 pin
Patient cable 5 lead
Environmental
Operating temperature 0°C to +45°C/32°F to 113°F
Non-operating temperature -10°C to +70°C/14°F to 158°F
Operating humidity 10% to 95% (non-condensing)
Non-operating humidity 5% to 95% (non-condensing)
DigiTrak XT Recorder Instructions for Use 2-9
Service and Specifications
Battery
Type
Life
Warranty
(1) AAA Alkaline IEC-LR3 for recordings
up to 96 hours
(1) AAA Lithium for recordings longer than
96 hours
168 hours (7 days)
24 months from shipment
2-10 DigiTrak XT Recorder Instructions for Use
Electromagnetic Compatibility (EMC)
Electromagnetic compatibility with surrounding devices should be assessed when using the
DigiTrak XT recorder.
An electronic device can either generate or receive electromagnetic interference. Testing for
electromagnetic compatibility (EMC) has been performed on the DigiTrak XT recorder
according to the international standard for EMC for medical devices (IEC 60601-1-2). This
IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The DigiTrak XT complies with the requirements of standard EN 60601-1, as follows:
The equipment is not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide.
IPX3 ordinary equipment (enclosed equipment with protection against spraying water).
The recorder will withstand exposure to liquids, such as rain, or splashing water. The
recorder will not survive full immersion or liquid spray under pressure. The patient should
be instructed not to wear the recorder in the shower or bath.
A
Appendix A
Internally powered equipment
Mode of operation - continuous operation.
The DigiTrak XT recorder should not be used adjacent to, or stacked on top of other
equipment. If the DigiTrak XT recorder must be used adjacent to or stacked on top of other
equipment, verify that the recorder operates in an acceptable manner in the configuration in
which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the
performance of medical equipment. For more information on troubleshooting, see
“Troubleshooting” on page 2-2.
The list of cables with which Philips claims compliance with emissions and immunity
requirements of IEC 60601-1-2 are listed on page 2-7.
A-1
Only use Philips Medical Systems replacement parts with the DigiTrak XT recorder. The use
of non-approved replacement parts may result in increased Radiated Emissions or decreased
Electromagnetic Immunity of the DigiTrak XT recorder.
Table A-1. Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The DigiTrak XT recorder is intended for use in the electromagnetic environment specified
in the table below. The customer or the user of the DigiTrak XT recorder should assure that
it is used in such an environment.
Emissions Test Compliance Electromagnetic
Environment: guidance
RF Emissions CISPR 11 Group 1 The DigiTrak XT recorder uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause any
interference in nearby
electronic equipment.
Harmonic Emissions IEC
61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Not Applicable
Not Applicable
A-2 DigiTrak XT Recorder Instructions for Use
Electromagnetic Compatibility (EMC)
Table A-2. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The DigiTrak XT recorder is intended for use in the electromagnetic environment specified
below. The customer or the user of the DigiTrak XT recorder should assure that it is used in
such an environment.
Immunity Test IEC 60601 Test
Level
Electrostatic
Discharge (ESD)
+/- 6 kV contact
+/- 8 kV air
IEC 61000-4-2
Electrical Fast
transient/burst
IEC 61000-4-4
+/- 2 kV for power
supply line
+/- 1 kV for input/
output lines
Surge IEC 610004-5
+/- 1 kV differential
mode
+/- 2 kV common
mode
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines IEC
<5% U
(>95% dip in UT) for
0.5 cycle
40% U
(60% dip in UT) for 5
cycles
T
T
61000-4-11
70% U
T
(>30% dip in UT) for
25 cycles
Compliance Level Electromagnetic
Environment:
Guidance
Complies Floors should be wood,
concrete, or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
N/A The DigiTrak XT does
not have AC or DC
power lines.
N/A The DigiTrak XT does
not have AC or DC
power lines.
N/A The DigiTrak XT does
not have AC or DC
power lines.
<5% U
T
(>95% dip in UT)
for 5 seconds
Power frequency
3 A/m Complies Power frequency
(50./60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the AC mains voltage prior to application of the test level.
DigiTrak XT Recorder Instructions for Use A-3
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Table A-3. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The DigiTrak XT recorder is intended for use in the electromagnetic environment specified
below. The customer or the user of the DigiTrak XT recorder should assure that it is used in
such an environment.
Immunity Test IEC 60601
Test Level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
Compliance Level Electromagnetic Environment:
guidance
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the DigiTrak XT,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
D = 1.2vP
D = 1.2vP 80 MHz to 800 MHz
D = 2.3vP 800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and D
is the recommended separation
distance in metres (m).
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from surfaces, objects, and people.
Additional notes are on following page.
A-4 DigiTrak XT Recorder Instructions for Use
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Electromagnetic Compatibility (EMC)
ADDITIONAL NOTES
A Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the DigiTrak XT recorder is used exceeds the applicable RF
compliance level above, the DigiTrak XT recorder should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the DigiTrak XT recorder.
B Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
Table A-4. Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the DigiTrak XT recorder: for equipment and
systems that are not life-supporting
The DigiTrak XT recorder is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the DigiTrak XT
recorder can help to prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
DigiTrak XT recorder as recommended below, according to the maximum output power of
the communications equipment.
Rated Maximum Output
Power of Transmitter W
Separation Distance According to Frequency of
Transmitter (m)
150 KHz to
80 MHz
D = 1.2vP
80 MHz to
800 MHz
D = 1.2vP
800 MHz to 2.5
GHz
2.3vP
0.01 .12 .12 .23
0.1 .38 .38 .73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12.0 12.0 23.0
For transmitters rated at a maximum output power not listed above, the recommended
separation distance D in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by the absorption and reflection from structures, objects, and people.
DigiTrak XT Recorder Instructions for Use A-5
Index
B
battery cover
replacing 2-8
C
calling for service 2-4
changing recorder settings 1-17
channels 1-6
cleaning the recorder 2-1
connecting the recorder to the dual
dock 1-9
contrast 1-6
D
default settings 1-6
deleting patient information 1-19
documentation
accessing at the Philips Website 1-3
updates at InCenter 1-3
downloading data from the recorder 1-16
dual dock 1-9
E
early out procedure 1-19
ECG signal quality 1-14
Electromagnetic Compatibility
(EMC) A-1
I
indications for use i-v
L
languages 1-6
lead status 1-6, 1-14
P
pacemaker detection 1-6, 1-17
parts 2-7
patient event marker 1-18
patient information, entering 1-11
patient preparation 1-12
R
record time 1-6
recorder
back view 1-5
changing settings 1-17
checking lead status and ECG signal
quality 1-14
cleaning 2-1
connecting to the dual dock 1-9
downloading data 1-16
entering patient information 1-11
features 1-1
front view 1-4
functions 1-6
indications for use i-v
navigating the display 1-7
safety information i-v
saving default settings 1-17
security recommendations i-viii
serial number 1-5
service tag 1-5
setting the recorder date and time 1-8
shutting down 1-16
specifications 2-9
stopping 1-19
supplies and parts 2-7
system requirements 1-2
troubleshooting 2-2
registering an event 1-18
resolution 1-6
S
safety information i-v
sample rate 1-6
saving default settings 1-17
security recommendations i-viii
serial number 1-5
service 2-4
service tag 1-5
setting the recorder date and time 1-8
settings
contrast 1-6
default settings 1-6
languages 1-6
pacemaker detection 1-6
record time 1-6
resolution 1-6
sample rate 1-6
shutting down the recorder 1-16
specifications 2-9
stopping a recording 1-19
supplies 2-7
system requirements 1-2
T
troubleshooting 2-2
M
multi day scans 1-2
Index-1
Copyright © 2008
Koninklijke Philips Electronics N.V.
All rights are reserved.
Printed in the U.S.A.
January 2008
Edition 1
453564064111
*453564064111*
*1*
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