05
18
9) Apply stimulation only to normal, intact, clean, healthy skin.
10) Do not apply stimulation across the patient's chest because the introduction
of electrical current into the chest may cause rhythm disturbances to the
patient's heart, which could be lethal.
11) This unit must be used with the guidance of a physician, speech therapist,
speech language pathologist, occupational therapist or physical therapist.
12) Do not insert lead wires into a mains power supply.
13) Do not immerse unit into water or any other substance.
14) Do not use this device in the presence of a flammable anesthetic gas mixture
and air or with Oxygen or Nitrous Oxide.
15) Plug the lead wire out of the device and do not use while charging.
16) Patient Electrodes are for single patient use only.
17) Keep out of reach of children.
18) Do not apply stimulation over, or in proximity to, cancerous lesions.
19) Do not apply stimulation while the patient is driving, operating machinery,
or during any activity in which electrical stimulation can put the patient at
risk of injury.
Precautions
Precautions should be observed in the presence of the following
1) When there is a tendency to hemorrhage following acute trauma or fracture.
2) Following recent surgical procedures when muscle contractions may disrupt
the healing process.
5) Do not apply stimulation in the presence of electronic monitoring equipment
(e.g., cardiac monitors, ECG alarms), which may not operate properly when
the electrical stimulation device is in use.
6) Do not apply stimulation when the patient is in the bath or shower.
7) Do not apply stimulation while the patient is sleeping.
8) Consult with the patient's physician before using this device because the device
may cause lethal rhythm disturbances to the heart in susceptible individuals.
4) Stimulation should not be applied over swollen, infected, or inflamed areas or
skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
Warnings
1) The long-term effects of electrical stimulation are unknown.
2) Stimulation should not be applied transthoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
3) Stimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reflex.
3) Use caution if stimulation is applied over the menstruating or pregnant uterus.
4) Where sensory nerve damage is present by a loss of normal skin sensation.
This Aspire 2 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.
The Aspire 2 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings and homes used for
domestic purposes.
MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS
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.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fuctuations/
Flicker emissions
IEC 61000-3-3
Complies
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient burst
IEC 61000-4-4-
Surge
IEC 61000-4-5-
Voltage dips,
short inter-
ruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/6- Hz)
magnetic field
IEC 61000-4-8
±
6 kV
contact
±
8 kV
air
±
2 kV
for
power supply
lines
±
2kV
line
(
s
)
and neutral
<5% UT
(>95% dip in U
T)
for 0.5 cycle
40& UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5s
3 A/m
±
8kV
contact
±
15kV
air
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
±
2 kV for power
supply lines
±
1 kV line(s) to
line(s)
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
3 0A/m
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the (Name or model) requires continued opera-
tion during power mains interruptions, it is re-
commended that the (Name or model) be
powered from an uninterruptible power supply
or a battery.