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4
1
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Patient Safety Information
Caution
Federal law (USA) restricts this device to sale by or on the
order of a physician so licensed by the State.
Indications
Transcutaneous Electrical Nerve Stimulation (TENS) devices
are used for the symptomatic relief and management of
chronic (long-term) intractable pain and as an adjunctive treat-
ment in the management of post-surgical and post-traumatic
acute pain problems.
Contraindications
TENS devices can adversely affect the operation of demand-
type cardiac pacemakers. TENS is not recommended for
patients with known heart disease without a physician’s
evaluation of risk. Do not stimulate over the eyes or carotid
sinus nerves. Do not apply TENS for undiagnosed pain syn-
dromes until etiology is established. Do not place electrodes
in a manner that causes current to flow transcerebrally
(through the head).
Warnings
This device should be used only under the continued su-
pervision of a physician, or outside the USA, by a qualified
pain management specialist. TENS is ineffective for pain of
central origin. TENS is of no curative value; it is a symptom-
atic treatment which suppresses pain sensation which would
otherwise serve as a protective mechanism on the outcome
of the clinical process. Safety of TENS devices for use during
pregnancy or delivery has not been established.
Electronic equipment such as ECG monitors and ECG alarms
may not operate properly when TENS is in use. Using this
device in proximity to any object that produces an elec-
tromagnetic current such as a microwave oven or cellular
telephone could affect the performance of the device. The
Operating Instructions
user must keep the device out of the reach of children. TENS
is for external use only.
Use of electrodes and accessories
Electrodes used with the device should be no smaller than
3
/
4
" in diameter. Please note that the smaller the size of the
electrode used, the greater the intensity of stimulation at the
electrode site which increases the likelihood of skin irritation
at the site. Only BioMedical Life Systems authorized electrodes
and accessories are to be used with this device. If you have
any questions, please contact either your dealer/distributor
or BioMedical Life Systems directly.
Precautions
Avoid adjusting controls while operating machinery or ve-
hicles. Turn the stimulator off before applying or removing
electrodes. Isolated cases of skin irritation may occur at the
site of electrode placement following long-term application.
Use only for the specific pain problem as prescribed by the
physician, or outside the USA, by a qualified pain management
specialist. Effectiveness is dependent upon patient selection
by a qualified pain specialist.
EQUIPMENT not suitable for use in the presence of a FLAM-
MABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN
OR NITROUS OXIDE
Adverse Reactions
Possible allergic reaction to tape or gel. Possible skin irrita-
tion or electrode burn.
This device is a Transcutaneous Electrical Nerve Stimulator.
One pair of electrodes can be connected to each output
channel using the leadwires supplied. Stimulation pulses
are transferred from the device through the leadwires to the
electrodes. The intensity, duration, and number of pulses per
second can be adjusted.
Instructions for use
• Attach leadwires to Channel 1 (CH1) and, if instructed
by clinician, to Channel 2 (CH2). (1 and 2)
• Attach electrodes to leadwires following instructions on
electrode packaging.
• Place electrodes on body as directed by clinician.
• Turn on device (9).
• Readout similar to (3) will appear on Display Screen.
• If no electrodes are applied to the body, a safety
feature is enabled and the amplitude drops to
zero and an "open electrode" symbol flashes on
the screen.
Programming a Stimulation Pattern
Select the desired stimulation pattern by pushing the Mode
Button (6) until the desired stimulation pattern is displayed
on the Screen (3). The patterns will appear in the following
sequence:
CONSTANT
= Constant/Continuous
BURST I
= BURST I
BURST II
= BURST II
PW. MOD.
= Pulse Width Modulation
PR. MOD.
= Pulse Rate Modulation
Select the desired pre-programmed stimulation pattern by
pushing the Mode Button (6) until the desired patten is
displayed on the screen (3).
Accessories
2 Leadwires with elec-
trodes
Only use accessories, electrodes,
leadwires and batteries approved
by BioMedical Life Systems, Inc.
We do not recommend the use of
rechargeable batteries, as they may
weaken the performance and/or
read-out of the device.
1 Instruction Booklet
2 Batteries
1 Carry Pouch
Technical Data
Dimensions 4.2” x 2.9” x 1.4”( 10.7cm x 7.4cm x 4cm)
Weight
3.35 oz (94.97 grams)
Channels
Dual
Power Sup-
ply
2 AA Batteries, Type LR6
Waveform
Symmetrical, biphasic square wave
Pulse Rate
(Hz)
1 - 120 Hz (Hertz or pps) adjustable
Pulse Width
(µS)
25 - 250 microseconds (μs) adjustable
Constant
Continuous stimulation. Pulse Rate/Pulse
Width are adjustable.
Pulse Rate
Modulation
Pulse Rate modulates from 100Hz down to
20Hz over a 15 second cycle (7.5 seconds
down 7.5 seconds up. Pulse width is adjust-
able.
Pulse Width
Modulation
Pulse width modulates from 125-250μS
and back down over a 5 second cycle (2.5
seconds down, 2.5 seconds up). Pulse Rate
is adjustable.
Burst I
One second ON. One second OFF. Pulse Rate
and Pulse Width are adjustable.
Burst II
Seven Pulses per burst, 2 bursts per second.
Pulse Width is adjustable.
Output
Constant current
Intensity
Continuously adjustable from
0- 100 mA peak to peak
Output Volt-
age
Continuously adjustable from 0-50 V peak
to peak
Tolerances
+/- 1%
(Data was recorded across a 500 OHM resistance load.)
Figure A
CONST
Figure B
PW MOD
Figure C
PR MOD
Figure D
BURST I & II
Graphic Symbol Definitions
mA CH1 mA CH2
TIMER
MODE
ON/OFF
P.W. (µS)
P.R. (Hz)
+
_
+
_
+
_
+
_
Impulse
®
TENS
D5
1
2
11
10
7 6
8
9
4
5
3
CONSTANT
120
Hz
50
µs
20
15
10
5
20
15
10
5
Ch1
Ch2
Refer to oper-
ating instruc-
tions
An IEC 601-1 safety
standard
(type BF)
0086
We herewith declare that the
above mentioned product meets
the provisions of the Medical De-
vice Directive
Figure 1
All pre-programmed stimulation patterns can be pro-
grammed for individual needs:
Increase or decrease the P.R. value by increasing the (+)
or decreasing the (-) P.R. button (8). The P.R. is adjustable
from 1-120 Hz in 5 Hz increments. Increase or decrease the
P.W. value by increasing the (+) or decreasing (-) P.W. but-
ton (7). The P.W is adjustable from 25-250 μS.
• Select the desired treatment time by pressing the Timer
Button (10) until the desired treatment time is displayed;
Continuous, Adjustable 10, 15, 20, 30, 45, 60 minutes
When a treatment time has been selected, the device
will count down the elapsed time and automatically turn
off.
• Increase or decrease the intensity of the device by press-
ing down the +/– for CH1 (4) or CH2 (5). There are 20
levels of intensity available.
• If a new mode selection (6) is made during treatment,
the intensity of the device automatically drops to Level
0.
• To immediately turn off the device at any time press the
On/Off (9) button.
• After the treatment period, disconnect leadwires from
device (1 & 2). Store electrodes as per instructions on
electrode package. If the device is not going to be used
for long periods of time the batteries should be removed
(11).
Programming
