Specifications

DL900 Holter Monitor
1
Description
This Operator Manual contains instructions for use for the DL900,
DL900 SD and DL900 SD 7 Day Holter Monitors. These Holter
Monitors are battery operated solid-state monitors. The DL900 and
DL900 SD Holter Monitor is designed for up to 120 hours (5 days)
of continuous recording of ambulatory electrocardiograph (AECG)
data. The DL900 7-Day Holter Monitor is designed for up to 168
hours (7 days) of continuous recording of ambulatory
electrocardiograph (AECG) data. All have the ability to detect and
record pacemaker pulses according to the appropriate criteria for
Association for the Advancement of Medical Instrumentation
(AAMI) pacer detection.
The DL900 Series Holter Monitors are an AAMI Type I device and
are also part of a conventional AECG recording system where the
ECG is recorded on a memory card that may be removed from the
monitor after the recording is complete. The memory card is then
placed in a card reader that is connected to the Computer Analysis
System. By following the instructions provided with your Computer
Analysis System, the recorded ECG data is downloaded from the
memory card for analysis. Data can also be viewed by
downloading the recorded information via a USB Cable.
The DL900 series Holter monitor is compatible with computers that
comply with EN60950 and have an operating system of Windows
XP or newer that are equipped with properly functioning and
configured hardware, software, and drivers that comply with
Universal Serial Bus Specification rev. 2.0, and the USB Mass
Storage Class specification ver. 1.0.
Indications for Use
The DL900 Series Holter Monitors are intended for patients
requiring ambulatory (Holter) monitoring. The following is a listing
of the most frequent indications for use:
1. Evaluation of symptoms suggesting arrhythmia or myocardial
ischemia.
2. Evaluation of ECG documenting therapeutic interventions in
individual patients or groups of patients.
3. Evaluation of patients for ST segment changes.
4. Evaluation of a patient’s response after resuming occupational
or recreational activities (e.g., after M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
DL900 Holter Monitor
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6. Evaluation of patients with pacemakers.
7. Reporting of time and frequency domain heart rate variability.
8. Reporting of QT Interval.
Recent DL900 Changes
Memory card technology changes continue to occur. Effective
January 16, 2012, new Braemar certified SD Memory cards are
available to order for existing DL900 Holter units in the field that
have utilized the MMC memory card and need a replacement
memory card. The replacement SD Memory Cards will include an
instruction sheet. SD Memory Cards will also be used for any RMA
unit that requires memory card replacement.
DL900 Phison SD Card Service Instructions
Your replacement Holter memory card is a different memory type
than the card originally supplied with your monitor. Recent
changes in memory technology from an older style MMC standard
to the current SD memory format have resulted in slightly higher
power consumption while recording. Older MMC card technology
is now unavailable for commercial applications.
Braemar recommends that any recording in excess of 48 hours be
performed with a new lithium battery installed at the time the
recording is started. Our testing has shown typical performance as
shown in the table below. Actual recording lengths can vary based
upon numerous factors including the brand of battery, state of
charge of the battery, age of battery, actual power consumption of
the circuit board, and other factors.
Typical Running Length (Hours) with Different Sample Rates
AAA Alkaline LR03
Average running length
in number of hours.
1, 2
10 Bit
128
sps
133
sps
180
sps
256
sps
512
sps
1024
sps
3 Channel
90
-
-
81
55
33
AAA Lithium L92-FR03
Average running length
in number of hours.
1, 2
10 Bit
128
sps
133
sps
180
sps
256
sps
512
sps
1024
sps
3 Channel
120
-
-
118
82
-
1. Based upon testing with an Energizer LR03-AM4 alkaline
battery and an Energizer L92-FR03 lithium battery.
2. 8 bit resolution can be expected to be within 5% of 10 Bit
resolution.