Instruction Manual

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Specications
Size 3.9" x 2.5" x 1.1"
Weight 3.25 oz.
Power Source 2 AA Batteries, Type LR6
Channels Dual (2)
Waveform Asymmetrical, biphasic square wave
Pulse Rate 1 - 200 Hz (Hertz or pps) adjustable
Please read the following prescription information carefully
before using the BioStim® M7. If you have any questions,
consult with your clinician before proceeding.
Caution:
Federal law (USA) restricts the sale by, or on the order of, a
physician licensed by the State.
Indications:
Only to be used under medical supervision for adjunctive
therapy in the treatment of medical diseases and conditions.
Applications:
Use for the relief from pain on targeted body parts.
Contraindications:
• Do not place electrodes and apply current to the carotid
sinus (neck) regions.
• Do not use TENS on patients who have a demand-type
cardiac pacemakers.
• Do not place electrodes in a manner that causes current
to ow transcerebrally (through the head).
• Do not use TENS whenever pain syndromes are undiagnosed,
until etiology is established.
Graphic Symbol Denitions
Electronic waste should
be disposed in the proper
manner in accordance
with local regulations.
Refer to
operating
instructions
2 BMLS® touch proof lead wires
4 BioStim® electrodes
2 AA Batteries
1 Carrying pouch
1 Instruction maual
Included Accessories
• BMLS approved rechargable AA NiMH batteries
• BMLS approved battery charger for AA NiMH batteries
• Assorted Biostim® electrodes
• Bifurcated cable for adding additional electrodes
Optional Approved Accessories
The BioStim® M7 is a portable dual channel transcutaneous
electrical nerve stimulator (TENS). It utilizes small electrical
currents aecting the nerves from sending pain signs to the
brain so that pain is not perceived. It has been evaluated for
pain relief eects of which has supportive evidence.
Patient Safety Information
Warnings:
• The safety of TENS during pregnancy, labor or delivery has
not been established for either mother or fetus.
TENS is not eective for pain of central origin. (This in-
cludes headaches)
• TENS devices should be used only under the continued
supervision of a physician.
• TENS devices have no curative value.
TENS is a symptomatic treatment and as such suppresses
the sensation of pain which would otherwise serve as a
protective mechanism.
• Kept out of reach of children.
• Electronic monitoring equipment (such as ECG monitors
and ECG alarms) may not operate properly when TENS
stimulation is in use.
Precautions:
• Isolated cases of skin irritation may occur at the site of
electrode placement following long-term application.
Eectiveness is highly dependent upon patient selection
by a person qualied in the management of pain patients.
Adverse Reactions:
Improper use of stimulation or the use of non-approved
BioMedical Life Systems (BMLS®) electrodes may result in
skin irritation and/or burns.
Additional Concerns:
• TENS is not recommended for patients with known heart
disease or cancer.
• Adequate precautions should be taken for persons with
suspected or diagnosed epilepsy.
• Do not place electrodes across laryngeal and pharyngeal
muscles (throat). Stimulation may be strong enough to close
o the airway or cause diculty in breathing.
• Never operate potentially dangerous machinery such as
power saws, automobiles, etc. during stimulation.
• Do not use on swollen, infected or inamed areas or skin
eruptions, e.g., phlebitis, thrombophlebitis or varicose veins.
• Some patients may experience skin irritation hypersensitiv-
ity due to electrical stimulation or the electrical conductive
medium used. Should this occur, remove the electrodes,
discontinue stimulation and consult your clinician to determine
the cause of irritation.
• Turn the stimulator o before applying or removing elec-
trodes.
EQUIPMENT not suitable for use in the presence of a FLAM-
MABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN
OR NITROUS OXIDE.
Product Description
Leadwire (1, 2) and electrode connection
Connection of the electrodes is made using the leadwires
with each connector rmly placed into the device sockets.
Then attach electrodes to leadwires.
Power button (9) to turn on device
Similar Display Screen (3) will appear.
Pulse Rate P.R. button (8)
Set value by pressing (+) to increase or (-) to decrease
as needed. Your selection will be displayed on the screen
between 1 - 120Hz.
Pulse Width P.W. Dial (7)
Set value by pressing (+) to increase or (-) to decrease as
needed. Selection will be displayed on the screen between
50-250μs. Higher P.W. will provide a more aggrestive feel.
Mode button (6)
Select between 7 mode selections. All pre-programmed stimu-
lation patterns can be adjusted for individual needs. Once a
mode has been selected the mode will appear on the screen:
• CONSTANT: (See Figure B)
• PULSE WIDTH MODULATION: 50% decrease over 6 sec-
onds of the pulse width value, then back to its original
value over 6 seconds. (See Figure C)
• PULSE RATE MODULATION: 50% decrease over 6 seconds
of the pulse rate value, then back to its original value
over 6 seconds.(See Figure D)
• PULSE WIDTH & RATE MODULATION: Pulse width and
pulse rate alternately decrease and increase 45% of their
set values over 6 seconds.(See Figure E)
• STRENGTH DURATION 1: As pulse width increases 40%,
pulse rate decreases 45%, and amplitude decreases 10%
over a 3 second period. Values return to original settings
over the next 3 second period. (See Figure F)
• STRENGTH DURATION 2: As pulse width increases 60%,
pulse rate decreases 90%, and amplitude decreases 13%
over a 6 second period. Values return to original settings
over the next 6 second period. (See Figure F)
CYCLED BURST: 2.5 Seconds on/2.5 seconds o. (See
Figure G)
General Operating Instructions
Pulse Width
10 - 250 microseconds (μs) adjustable
Modes Continuous
Pulse Rate Modulation
Pulse Width Modulation
Pulse Width & Rate Modulation
Strength Duration 1
Strength Duration 2
Cycled Burst
Output Constant current
Intensity Continuously adjustable from 0- 98 mA
zero to peak
Output Voltage Continuously adjustable from 0-49 V
zero to peak
Tolerances +/- 10%
Output parameters are across a 500 ohm resistance
Unique BioStim® M7 pulse pattern by mode
(B) Constant
(C) PW Modulation
(D) PR Modulation
(E) PW/PR Modulation
(F) SD1 / SD2
(G) Cycle Burst
10
9
8
7
6
5
4
3
2
1
10
9
8
7
6
5
4
3
2
1
CONST
Hz
B
IO
M
EDICAL
50
120
CH1
Lead Wire
Inlet
Amplitude
CH1
Pulse
Rate
Battery
Pulse
Width
CH2
Lead Wire
Inlet
On/Off
Mode
Amplitude
CH2
Timer
4
8
10
7
6
9
1
2
5
11
3
Screen
TOP VIEW
OPEN
VIEW
Figure A

Summary of content (2 pages)