19
04
Chapter 2 General Warnings and Precautions
Please carefully read the user manual before use. If you have any
questions please contact your physician, rehabilitation therapist
or your training manual before proceeding.
Indications for Use
* Prevention or retardation of disuse atrophy
* Relaxation of muscle spasms
* Increasing local blood circulation
* Immediate post-surgical stimulation of calf muscles to prevent venous throm-
bosis
* Maintaining or regaining range of motion
* Biofeedback
* Detecting and extracting an active EMG signal
Contraindications
1) Do not use this device on patients who have a cardiac demand pacemaker,
implanted defibrillator, or other implanted metallic or electronic device because
this may cause electric shock, burns, electrical interference, or death.
2) Electronic muscle stimulation stimulators, including this unit, should not be
used on patients with any form of cancer.
* Muscle re-education
List of Symbols
Type BF Applied Part(s)
Caution
Consult Instructions for Use
Portable and mobile RF communications equip-
ment should be used no closer to any part of this
Aspire 2 including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.7 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 meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a),
should be less than the compliance level in each
frequency range b). Interference may occur in the
vicinity of equipment marked with the following
symbol:
MANUFACTURER
’
S
DECLARATION
–
ELECTROMAGNETIC
IMMUNITY
This Aspire 2 is intended for use in the electromagnetic environment specified below. The customer
or the
user
of this
Aspire 2
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF 3Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
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 refection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, 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
this Aspire 2 is used exceeds the applicable RF compliance level above, this Aspire 2 should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating this Aspire 2.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 30 V/m.
Chapter 7 Manufacturer's Declaration
6Vrms
3 V/m