NorthEast Monitoring, Inc. NEMM019-Rev-O
Page 4 of 35
DR200/HE & DR300 Operator’s Manual
Introduction: Intended Use
Power Supply
The DR200/HE & DR300 Digital Recorder is
powered by one 1.5 volt AA battery, not
included. An AA alkaline battery (MN1500 or
the equivalent), a AA rechargeable NiMH
(nickel metal hydride) battery, or oa AA
Eveready Lithium L91 battery can be used.
Although battery life may last longer than a
recording, batteries should not be re-used for a
second patient. After one use, they should be
disposed of following local ordinances.
Do not leave battery in the recorder for
extended periods (more than two weeks) when
the recorder is not in use.
If you use rechargeable batteries, the battery
recharger should be kept out of the patient
environment and hook-up area. For details
about recommended batteries/chargers, see
Appendix B.
Environmental Specifications
This equipment is not suitable for use in the
presence of a flammable anesthetic mixture
with air, oxygen, or nitrous oxide.
The operating range of the device is between
10 and 45 degrees C, between 10 and 95%
humidity, and between 700 and 1060 hPa pres-
sure.
Store and/or transport the recorder at tempera-
tures between -40 and 70 degrees C, between
10 and 100% relative humidity, and 500 and
1060 hPa pressure.
The recorder has an Ingress Protection Mark-
ing of IP22. The solid particle protection is
level 2 as the device is protected against
objects > 12.5mm, such as fingers or similar
objects. The liquid ingression protection is
level 2, which meant that vertically dripping
water shall have no harmful effect when the
enclosure is tilted at an angle up to 15° from its
normal position.
Wireless Specifications
The DR300 recorder is equipped with wireless
Bluetooth transmitter. A NorthEast Monitoring
DR300 Gateway and Bluetooth USB Dongle is
able to receive the encrypted Event and Holter
data. (The USB Dongle only works with Event
data.) The Bluetooth specifications for the
DR300 are:
•
Receive Sensitivity: 95 dBm
•
Output Power: 10.5 dBm max
•
Link Budget: Up to 105.5 dB
•
RX/TX Turnaround: 150 us
•
Frequency: 2402 – 2480 MHz in 1 Mhz
steps
•
Data Rate and Modulation:
BR:1 Mbps,
GFSK / EDR: 2-3 Mbps PSK
•
Number of Channels: 79
Intended Use
•
Holter Mode:
Detection of Arrhythmias,
Efficacy of Pharmacological Treatment,
and Pacemaker Evaluation.
•
Event Mode:
The event recorder module is
a patient activated device designed to
record and for diagnostic evaluation of tran-
sient symptoms (such as dizziness, palpita-
tions, syncope, and chest pain).
Indications for Use
1.
Detection of Arrhythmias:
The DR200/
HE & DR300 Digital Recorder is indicated
for use in continuous monitoring of cardiac
rhythm when intermittent arrhythmia are
suspected due to patient symptoms such as
palpitations, transient ischemic attacks
(TIAs), syncope (fainting), or other such
symptoms as determined by the physician.
2.
Efficacy of Treatment:
The DR200/HE &
DR300 Digital Recorder is indicated for use
to determine whether current pharmacologi-
cal treatment(s) of known arrhythmia is
effective by measuring the frequency and
