Intended Use, Indications and Mode of Operation
77811011
PhysioMem
®
PM 100 2G
5
1
Intended Use, Indications and Mode of
Operation
These operating instructions are intended for medical professionals.
1.1
Intended Use
The PM 100 device is a two-channel cardiac event recorder for
transmitting multiple event recordings via cellular telephony net-
works to a compatible receiving system, such as ReSTA from
GETEMED.
The device is intended for patient activated recordings.
The PM 100 is intended to be used in both home environments and
clinical environments. Home environments include urban/suburban/
rural, school/office/retail environments, and vehicles like trains and
cars. Airplanes are excluded as long as the use of cellular radio
equipment is not allowed during flight. The device is battery-driven
and utilizes a FLASH memory to store ECG data. The PM 100 is not
intended to be used as a critical care monitoring system and should
not be used in emergency situations.
1.2
Indications
The PhysioMem PM 100 2G is indicated for the diagnostic evaluation
of adult and pediatric (over 10 kg body weight) patients with asymp-
tomatic and symptomatic disturbances of the cardiac rhythm and for
the evaluation of recurrent unexplained episodes of racing heart,
syncope, palpitations or dizziness.
Patients with an age of less than 14 years need support from adults.
The device is not indicated for patients whose clinical condition re-
quires continuous monitoring of vital physiological parameters,
