Professional Documents
Culture Documents
User Manual
Copyright:
Enraf-Nonius B.V.
P.O. Box
2600 AV DELFT
The Netherlands
info@enraf-nonius.com
www.enraf-nonius.com
December 2002
Table of Content
1 Product Description...........................................................................................3
2 Foreword..............................................................................................................3
2.1 This manual........................................................................................................................ 3
2.2 Product liability................................................................................................................... 3
2.3 Limitations of liability.......................................................................................................... 3
3 Precautionary Instructions................................................................................4
4 Intended Purpose...............................................................................................5
4.1 Pain Management (TENS).................................................................................................5
4.1.1 Indications/Contraindications and Adverse Effects for Pain Management............................5
4.1.2 Current Waveform.................................................................................................................5
5 Package Contents...............................................................................................6
5.1 Standard Accessories........................................................................................................ 6
5.2 Optional Accessories.......................................................................................................... 6
6 Installation...........................................................................................................6
7 Application of Electrodes..................................................................................7
7.1 Before treatment................................................................................................................ 7
7.2 Self-adhesive electrodes.................................................................................................... 7
7.3 Electrolytic effects.............................................................................................................. 7
7.4 Current density................................................................................................................... 7
7.5 Connection and disconnection reactions............................................................................7
8 Operating Instructions.......................................................................................8
8.1 Operator Controls............................................................................................................... 8
8.2 Intensity adjustment........................................................................................................... 9
8.3 Safety features................................................................................................................... 9
8.4 Additional features.............................................................................................................. 9
8.5 Usage monitor.................................................................................................................... 9
8.6 Basic Operation.................................................................................................................. 9
8.6.1 Operation by Program...........................................................................................................9
8.6.2 Programs.............................................................................................................................10
8.6.3 Manual operation................................................................................................................. 10
8.7 Doctor Locking................................................................................................................. 10
8.7.1 Program Locking..................................................................................................................10
8.7.2 Manual Program Locking.....................................................................................................11
8.8 User Maintenance............................................................................................................ 11
8.8.1 Cleaning of apparatus..........................................................................................................11
8.8.2 Patient cable........................................................................................................................11
8.8.3 Care of electrodes...............................................................................................................11
8.9 End of life......................................................................................................................... 11
9 Stimulator Output Parameters........................................................................12
10 Illustrations........................................................................................................12
10.1 Asymmetrical biphasic TENS waveform.......................................................................12
10.2 Asymmetrical biphasic burst TENS waveform..............................................................12
11 Technical Specifications..................................................................................13
1 Product Description
The TensMed 911 is a 2-channel electrotherapy apparatus, that has optimized pain management, using
asymmetric TENS current waveforms.
Protocol driven operation provides both factory or user defined treatments. In this mode the 2 channels
are linked, i.e. parameter settings apply to all channels simultaneously, the treatment timer included.
With manual operation the channels are linked, the current amplitude can be set individually on each
channel.
WARNING (USA only): The TensMed 911 is a prescription device that should only be used under the
supervision or by the order of a physician or other licensed healthcare provider.
2 Foreword
This manual has been written for the owners and operators of the TensMed 911. It contains general
instructions on operation, precautionary practices, maintenance and parts information. In order to
maximize use, efficiency and the lifetime of your unit, please read this manual thoroughly and become
familiar with the controls as well as the accessories before operating the unit.
Specifications put forth in this manual were in effect at the time of publication. However, owing to
Enraf-Nonius BV policy of continual improvement, changes to these specifications may be made at any
time without obligation on the part of Enraf-Nonius BV.
A law on Product Liability has become effective in many countries. This Product Liability law implies,
amongst other things, that once a period of 10 years has elapsed after a product has been brought into
circulation, the manufacturer can no longer be held responsible for possible shortcomings of the
product.
To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or
resellers be liable for any indirect, special, incidental or consequential damages arising from the use of
or inability to use the product, including, without limitation, damages for loss of goodwill, work and
productivity, computer failure or malfunction, or any and all other commercial damages or losses, even
if advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort or
otherwise) upon which the claim is based. In any case, Enraf-Nonius’s entire liability under any provision
of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees
for support of the product received by Enraf-Nonius under a separate support agreement (if any), with
the exception of death or personal injury caused by the negligence of Enraf-Nonius to the extent
applicable law prohibits the limitation of damages in such cases.
Enraf-Nonius can not be held liable for any consequence resulting from incorrect information provided
by its personnel, or errors incorporated in this manual and / or other accompanying documentation
(including commercial documentation)
The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims
arising from third parties, whatever nature or whatever relationship to the opposing party.
3 Precautionary Instructions
In this section general Warnings and Precautions are listed, that you should be aware of when using the
TensMed 911. See also chapter 4 for Warnings and Precautions, that apply to Muscle Stimulation
applications in particular.
WARNING:
• • Federal law (USA only) restricts this device to sale by, or on the order of, a physician or
licensed practitioner.
This device should be used only under the continued supervision of a physician or licensed
practitioner.
CAUTION:
• • Read, understand and practice the precautionary and operating instructions. Know the
limitations and hazards associated with using any electrical stimulation device. Observe the
precautionary and operational decals placed on the unit
• • Do not operate the TensMed 931 when connected to any unit other than Enraf-Nonius BV
devices.
• • This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F),
with a Relative Humidity ranging from 10%-90%.
• • Do not expose the unit to direct sunlight, heat radiated from a heat radiator, excessive
amounts of dust, moisture, vibrations and mechanical shocks.
• • In the case of ingress of liquids, unplug the unit from the mains supply and have it checked
by an authorized person (see the paragraph on technical maintenance).
• • Do not use sharp objects such as a pencil point or ballpoint pen to operate the buttons on
the control panel as damage may result.
Before administering any treatment to a patient you should become acquainted with the operating
procedures for each mode of treatment available, as well as the indications, contraindications, warnings
and precautions. Consult other resources for additional information regarding the application of
electrotherapy.
4 Intended Purpose
Indications:
• • Symptomatic relief of chronic, intractable pain. Management of pain associated with post-
traumatic or postoperative conditions.
Contraindications:
• • This device should not be used for symptomatic pain relief unless etiology is established or
unless a pain syndrome has been diagnosed.
• • This device should not be used on patients with on demand type cardiac pacemakers.
• • This device should not be used over cancerous lesions.
• • Electrode placements must be avoided that apply current to the carotid sinus region
(anterior neck).
• • Electrode placements must be avoided that apply current transcereberally (through the
head).
• • Electrode placements must be avoided that apply current transthoracically (the introduction
of electrical current into the heart may cause cardiac arrhythmias).
Warnings:
• • Benefits of TENS currents have not been established for pain of central origin.
• • This device is to be used as a symptomatic treatment for pain and has no curative value.
Patients should be cautioned and their activities regulated if pain is suppressed that would
otherwise serve as a protective mechanism.
• • The long-term effects of chronic electrical stimulation are unknown.
• • Safety has not been established for the use of therapeutic electrical stimulation during
pregnancy.
• • Stimulation should not be applied over swollen, infected, or inflamed areas of skin
eruptions. e.g., phlebitis, thrombophlebitis, varicose veins, etc.
• • See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
Precautions:
• • Isolated cases of skin rash may occur at the site of electrode placement following long-term
applications. The irritation may be reduced by use of an alternate conductive medium or an
alternative electrode placement.
• • Effectiveness of this treatment is dependent upon patient selection.
• • See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
Adverse Effects:
• • Skin irritation and burns beneath the electrodes have been reported with the use of
therapeutic electrical stimulation.
For pain management the TensMed 911 offers the asymmetrical biphasic pulsed current waveform,
which is often used in TENS (Transcutaneous Electrical Nerve Stimulation) applications. This waveform is
an alternating current, characterized by variable phase duration and a variable pulse frequency. Its
typical characteristics amplitude, phase duration, and rate of rise and decay are unequal for each phase
with respect to the baseline. The waveform is fully balanced, i.e. the phase charges of each phase are
equal. See paragraph 10 for a graphical representation and paragraph 9 for the available parameters.
To prevent accommodation to stimulation or to improve patient tolerance, the pulse frequency can be
varied through frequency modulation. Several frequency modulation programs are available.
A burst frequency can be set for treating chronic pains, where the use of continuous stimulation with a
low pulse frequency would be too painful. A burst consists of an interrupted train of pulses. Each burst
lasts for 100 ms and the burst rate can separately be adjusted. See paragraph 10 for details. With this
milder TENS waveform it is easier to exceed the motorial threshold stimulus.
5 Package Contents
Carry Pouch
6 Installation
Insert Batteries:
Insert two batteries. (A diagram inside the battery compartment shows how to insert the batteries
correctly.)
To check if the batteries have been correctly fitted, press the ON/OFF button once and the LCD display
will start up and the LED Lights will come on. Press the ON/OFF button again to switch the unit off.
The battery contains material that is noxious to environment. You should attend the local regulations
when disposing the battery.
Attach Leads:
Unravel leads and insert the plug(s) into either sockets in the end of the unit. If using only one lead use L1
(as marked on the unit next to the socket).
• • Connection of accessories other than the ones specified by the manufacturer can adversely
affect the safety of the patient and correct functioning of the equipment, and is therefore not
permitted.
NOTE:
• • Check the patient for contraindications and warnings as described in paragraph 4.1 and 4.2
• • Test the heat sensibility of the treatment area.
• • Rinse the treatment area. Shaving a hairy skin is recommended.
Self-adhesive electrodes have higher series impedance than carbon rubber electrodes. This can cause
the stimulator to terminate treatment at higher current amplitudes. When this occurs it is
recommended to continue the treatment with carbon rubber electrodes, combined with properly
moistened sponge pads.
Self-adhesive electrodes are not recommended for use with currents that contain a DC component.
Electrolysis occurs under the electrodes when current types with a DC component are applied. Because
the largest concentration of electrolytic by-products caused by ion migration occur under the
electrodes, we recommend the use of the supplied sponges to keep the effects to a minimum. Make
sure that the sponges are kept well moistened and place the thick side of the sponge between the
flexible rubber electrodes and the patient.
7.4 Current density
According to IEC 60601-2-10 the maximum permissible “current density” is 2 mA RMS. per cm². With the
rubber electrodes this requirement is automatically met, as the output current of the stimulator is
limited to 50 mA RMS. With smaller electrodes, such as the 3.2 mm self adhesives, this is not the case.
To verify that the maximum permissible current density of 2 mA RMS. per cm² is not exceeded, divide
the RMS output current in mA by the effective electrode area in cm²: A value of less than 2 should
result. For asymmetrical TENS currents the RMS value of the output current can be calculated as follows:
For symmetrical TENS currents, the Phase duration should be multiplied by 2. The value of the peak
current Ipeak can be taken from the current display.
This device has Constant Current (CC) output characteristics, that may cause unpleasant connection and
disconnection reactions if the electrodes are not securely placed or lose contact with the skin. Make
sure the output is set to 0 mA when you apply or remove the electrodes.
This device has Constant Current (CC) output characteristics, that may cause unpleasant connection and
disconnection reactions if the electrodes are not securely placed or lose contact with the skin. Make
sure the output is set to 0 mA when you apply or remove the electrodes.
8 Operating Instructions
2 MENU 6
1 7
8 5
When the unit is switched on the yellow LED at the front of the unit will light and a single beep will sound.
Output intensity starts at zero.
The unit starts at the last program and/or manual setting used.
When the unit is switched off the LED will go out and two beeps will sound.
When you are satisfied with the setting, press the Menu key again to save it.
The MENU function accesses only the Timer when preset programs have been selected.
When program “m” is selected, it allows you to set parameters manually. Parameters that can be
selected are:
When you resume the program the intensity resets to level 1 and the timer symbol flashes until the
intensity button is pressed
Holding down the button with the key symbol for 2 secs locks all keys (including ON/OFF key) EXCEPT
INTENSITY DOWN.
If an attempt is made to alter settings while the keyboard is locked, the key symbol on the LCD flashes.
For unlock hold down the button with the key symbol for 2 seconds
The program M and N is for manual adjustment and allows to set Frequency, Pulse width, Constant,
Burst and Time.
When the unit is switched on, it will show the last program used.
h CAUTION:
Connection of accessories other than the ones specified by the manufacturer can adversely affect the
safety of the patient and correct functioning of the equipment, and is therefore not permitted.
The TensMed 911 has an intelligent intensity adjustment to minimise delay in waiting for the next work
period, and to avoid confusing the sensation from the two channels.
When either intensity button is pressed, the work/rest cycle is interrupted, and the other channel
intensity drops to zero. You can then set the intensity required. After you have finished setting, the
intensity will remain at the set level for 4 seconds, then both channels will begin the next rest period.
Each press of the Intensity button changes intensity by about 1V in normal mode and 2V in high output
mode.
If the Intensity button is held down > 0.5 sec it starts to scroll at two steps per sec (22 seconds to full
scale). If it is held > 2 seconds it scrolls at five steps per sec. When it is released it reverts to single steps.
If the unit is accidentally switched on and no other button is pressed within the next 5 minutes, the unit
will automatically switch off.
• • SOUND: When the unit is switched on an audible beep will be emitted. When the unit is
switched off there will be two audible beeps.
• • ON/OFF LIGHT: When the unit is on the LED light will light up. The light is located at the front
of the unit.
• • LOW BATTERY WARNING: There is a low battery detector in the unit. The LCD screen will flash
the symbol of a battery when the batteries need replacing.
A Usage Monitor is included to help your medical advisor plan your treatment. Press and hold down the
PROGRAM and MENU keys together for five seconds. The top left corner of the LCD screen will display
the length of time in hours that the unit has been used for. Press the same two keys again for five
seconds to return the screen to normal. Note that if the unit is switched off with the LCD screen
displaying the Usage Monitor it will be in this same mode when switched back on.
While the Usage monitor screen is open, Press LOCK and MENU keys together for five seconds to set to
zero.
The effect of each program varies from one person to another even if they have the same type of pain.
Choose the program which suits you best.
If you are using a TENS unit for the first time, and have not been advised otherwise, start with program
A. Programs A, D & F use the “Pain Gate” to block pain messages from reaching the brain.
Increase the intensity slowly until a strong but comfortable level of sensation is reached.
Keep your first treatment to 1 hour. Remember that you will have to increase the intensity during the
treatment to keep the sensation constant as the body gets used to the feeling.
Programs B, C and E produce a pulsing or tapping sensation associated with muscle contractions. It is
desirable that you experience a muscle contraction with these programs, therefore the intensity should
be increased and maintained at a level that produces muscle activity. In these programs pain relief is
achieved by triggering the release of endorphins, the body’s own pain relief mechanism.
If you find the muscle contractions with programs B and E uncomfortable, switch to program C. In mode
C the stimulus is delivered in bursts, i.e. a group of pulses rather than a single pulse. You will get muscle
activity at a lower intensity and thus you may find it more comfortable.
If you are using programs that produce muscle contractions, it is recommended that you also keep your
first treatment short (approximately 15 minutes) to check your response. Assuming no adverse reaction,
you can then increase subsequent treatment periods but subject to a maximum of 60 minutes at a time
to avoid muscle fatigue.
8.6.2 Programs
Prog Sensation Use for
The TensMed 911 may be set so that patient access is restricted to one program, allowing change of
Intensity and Timer only.
Any manual settings in Programs A, B, C, D, E, F, G, H, I, M, N will be retained if doctor lock is set. You
may therefore prescribe and lock any TENS setting.
To lock the unit, press the MENU and CH2 INTENSITY DOWN keys together and hold for 4 seconds until
key symbol appears in the lower left corner of the display.
To unlock the unit, press the MENU and CH2 INTENSITY DOWN keys together and hold for 4 seconds
until the key symbol disappears from the lower left corner of the display.
When the unit is locked, all values will be saved even if the batteries are removed.
When unlocked, removing the batteries will return all values except Usage Time to default settings.
The TensMed 911 may also be set to give the patient one customised programs to access according to
your instructions. Once parameters for manual programs G & H have been set, they can be protected
from further change by pressing MENU and CH1 INTENSITY DOWN keys together and holding for 4
seconds. If you attempt to change any of these parameters LOC will appear in the Hz display. Repeat to
release locking.
To clean the unit, turn it off. Clean the unit with a damp cloth. Do not use abrasive cleaners. A small
amount of mild household detergent may be used, if desired.
Check the cable regularly for damages and/or bad electrical contact. We advise to keep a spare patient
cable in stock.
The electrodes supplied with the TensMed 911 units are self-adhesive and can be used several times.
Skin must be allowed to breath therefore the electrodes should be removed periodically. When not in
use the electrodes should be placed back onto the clear plastic shield.
The condition of the electrodes does affect conductivity and, consequently, the performance of the unit.
When the electrodes initially lose their adhesive quality it is possible to reactivate the adhesiveness by
applying a fine spray of water. When used on clean skin and stored correctly, electrodes will last for
about 14 days.
8.9 End of life
The TensMed 911 contains materials that can be recycled and/or are noxious to the environment.
Specialized companies can dismantle the unit and sort out these materials. When you dispose of the
unit, first inform yourself about the local regulations concerning waste management.
Pulse frequency 1, 2, 3, 4, 5, 10, 12, 14, 16, 18, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 110, 120, 130, 140 and 150 Hz
Intensity modulation Program G, intensity down to 70% and back over 10 seconds
Pulse Width modulation Program H, pulse width modulation from 250µs to 50µs and back in 12
seconds
Amplitude 0 – 90 mA
10 Illustrations
t Pulse width
fp Pulse frequency
10.1 Asymmetrical biphasic TENS waveform
fB Burst frequency
Copyright:
Enraf-Nonius B.V.
P.O. Box
2600 AV DELFT
The Netherlands
Tel: +31 (0) 15 – 26 984 00
Fax: +31 (0) 15 – 25 61 686
info@enraf-nonius.com
www.enraf-nonius.com
1 Product Description
2 Foreword
2.1 This manual
2.2 Product liability
2.3 Limitations of liability
3 Precautionary Instructions
4 Intended Purpose
4.1 Muscle Stimulation
4.1.1 Indications/Contraindications and Adverse Effects for Muscle Stimulation
4.1.2 Current Waveform
5 Package Contents
5.1 Standard Accessories
5.2 Optional Accessories
6 Installation
7 Application of Electrodes
7.1 Before treatment
7.2 Self-adhesive electrodes.
7.3 Electrolytic effects
7.4 Current density
7.5 Connection and disconnection reactions
8 Operating Instructions
8.1 Operator Controls
8.2 Intensity adjustment
8.3 Safety features
8.4 Additional features
8.5 Basic Operation
8.5.1 Programs
8.5.2 Operation by Program
8.5.3 Manual operation
8.6 Doctor Locking
8.6.1 Program Locking
8.6.2 Manual Program Locking
8.7 User Maintenance
8.7.1 Cleaning of apparatus
8.7.2 Patient cable
8.7.3 Care of electrodes
8.8 End of life
9 Stimulator Output Parameters
10 Illustrations
11 Technical Specifications
1 Product Description
The TensMed 931 is a 2-channel electrotherapy apparatus, that is optimized for muscle stimulation
applications, using symmetric TENS current waveforms.
Protocol driven operation provides both factory or user defined treatments. In this mode the 2 channels
are linked, i.e. parameter settings apply to all channels simultaneously, the treatment timer included.
With manual operation the channels are linked, the current amplitude can be set individually on each
channel.
WARNING (USA only):The TensMed 931 is a prescription device that should only be used under the
supervision or by the order of a physician or other licensed healthcare provider.
2 Foreword
2.1 This manual
This manual has been written for the owners and operators of the TensMed 931. It contains general
instructions on operation, precautionary practices, maintenance and parts information. In order to
maximize use, efficiency and the lifetime of your unit, please read this manual thoroughly and become
familiar with the controls as well as the accessories before operating the unit.
Specifications put forth in this manual were in effect at the time of publication. However, owing to Enraf-
Nonius BV policy of continual improvement, changes to these specifications may be made at any time
without obligation on the part of Enraf-Nonius BV.
A law on Product Liability has become effective in many countries. This Product Liability law implies,
amongst other things, that once a period of 10 years has elapsed after a product has been brought into
circulation, the manufacturer can no longer be held responsible for possible shortcomings of the product.
To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or
resellers be liable for any indirect, special, incidental or consequential damages arising from the use of or
inability to use the product, including, without limitation, damages for loss of goodwill, work and
productivity, computer failure or malfunction, or any and all other commercial damages or losses, even if
advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort or
otherwise) upon which the claim is based. In any case, Enraf-Nonius’s entire liability under any provision
of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for
support of the product received by Enraf-Nonius under a separate support agreement (if any), with the
exception of death or personal injury caused by the negligence of Enraf-Nonius to the extent applicable
law prohibits the limitation of damages in such cases.
Enraf-Nonius can not be held liable for any consequence resulting from incorrect information provided by
its personnel, or errors incorporated in this manual and / or other accompanying documentation (including
commercial documentation)
The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims
arising from third parties, whatever nature or whatever relationship to the opposing party.
3 Precautionary Instructions
In this section general Warnings and Precautions are listed, that you should be aware of when using the
TensMed 931. See also chapter 4 for Warnings and Precautions, that apply to Muscle Stimulation
applications in particular.
WARNING:
• Federal law (USA only) restricts this device to sale by, or on the order of, a physician or licensed
practitioner.
This device should be used only under the continued supervision of a physician or licensed
practitioner.
• Do not operate the unit in an environment of short-wave or micro-wave diathermy use as this can
result in burns beneath the electrodes.
• Care must be taken when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try to
minimize this interference by not using other equipment in conjunction with it.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate
properly when electrical stimulation is being utilized.
• This equipment is not suitable for use in the presence of flammable anaesthetic mixture with air,
oxygen, or nitrous oxide.
• This device should be kept out of the reach of children.
CAUTION:
• Read, understand and practice the precautionary and operating instructions. Know the limitations
and hazards associated with using any electrical stimulation device. Observe the precautionary
and operational decals placed on the unit
• Do not operate the TensMed 931 when connected to any unit other than Enraf-Nonius BV
devices.
• This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F), with
a Relative Humidity ranging from 10%-90%.
• Do not expose the unit to direct sunlight, heat radiated from a heat radiator, excessive amounts
of dust, moisture, vibrations and mechanical shocks.
• In the case of ingress of liquids, unplug the unit from the mains supply and have it checked by an
authorized person (see the paragraph on technical maintenance).
• Do not use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the
control panel as damage may result.
Before administering any treatment to a patient you should become acquainted with the operating
procedures for each mode of treatment available, as well as the indications, contraindications, warnings
and precautions. Consult other resources for additional information regarding the application of
electrotherapy.
4 Intended Purpose
4.1 Muscle Stimulation
Indications:
• This device should not be used on patients with on demand type cardiac pacemakers.
• This device should not be used over cancerous lesions.
• Electrode placements that apply current to the carotid sinus region (anterior neck) must be
avoided
• Electrode placements that apply current transcereberally (through the head) must be avoided
• Electrode placements that apply current transthoracically (the introduction of electrical current
into the heart may cause cardiac arrhythmias) must be avoided
Warnings:
Precautions:
• Adequate precautions should be taken when treating individuals with suspected or diagnosed
heart problems, or epilepsy.
• Caution should be used when there is a tendency to hemorrhage following acute trauma or
fracture.
• Caution should be used following recent surgical procedures when muscle contraction may
disrupt the healing process.
• Caution should be used over the menstruating uterus.
• Caution should be used over areas of the skin which lack normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to electrical stimulation or
electrical conductive medium. The irritation can usually be reduced by using an alternative
conductive medium, or alternate electrode placement.
• See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
Adverse Effects:
• Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic
electrical stimulation.
Muscle stimulation is often carried out with the symmetrical biphasic pulsed current waveform. This
waveform is also fully balanced (no residual DC components are present). See on page 14 for a graphic
representation. Note that the specified phase duration applies to both pulse phases, which doubles the
amount of available energy with respect to the asymmetrical pulsed current waveform.
Muscle stimulation is often applied in combination with a surge program, which consists of a sequence of
exercise and rest periods. Several options are available here:
• Reciprocal application, where stimulation alternates between agonists and antagonists. This is
accomplished through asynchronous stimulation over two current channels with an appropriate
delay between the two channels.
• Co-contract application, where two channels operates synchronously to co-contract agonist and
antagonist or different sections of a larger muscle group.
5 Package Contents
1427950 TensMed 931
6 Installation
Insert Batteries:
Insert two batteries. (A diagram inside the battery compartment shows how to insert the batteries
correctly.)
To check if the batteries have been correctly fitted, press the ON/OFF button once and the LCD display
will start up and the LED Lights will come on. Press the ON/OFF button again to switch the unit off.
Attach Leads:
Unravel leads and insert the plug(s) into either socket in the end of the unit. If using only one lead use L1
(as marked on the unit next to the socket).
7 Application of Electrodes
hCAUTION:
• Connection of accessories other than the ones specified by the manufacturer can adversely
affect the safety of the patient and correct functioning of the equipment, and is therefore not
permitted.
NOTE:
• The description below applies to electrotherapy applications in general. The electrolytic effects
mentioned do not apply to the Tensmed 931 as this device only generates fully balanced TENS
currents, that do not contain a DC component.
• Check the patient for contraindications and warnings as described in paragraph 4.1 and 4.2
• Test the heat sensibility of the treatment area.
• Rinse the treatment area. Shaving a hairy skin is recommended.
Self-adhesive electrodes have higher series impedance than carbon rubber electrodes. This can cause
the stimulator to terminate treatment at higher current amplitudes. When this occurs it is recommended to
continue the treatment with carbon rubber electrodes, combined with properly moistened sponge pads.
Self-adhesive electrodes are not recommended for use with currents that contain a DC component.
Electrolysis occurs under the electrodes when current types with a DC component are applied. Because
the largest concentration of electrolytic by-products caused by ion migration occur under the electrodes,
we recommend the use of the supplied sponges to keep the effects to a minimum. Make sure that the
sponges are kept well moistened and place the thick side of the sponge between the flexible rubber
electrodes and the patient.
According to IEC 60601-2-10 the maximum permissible “current density” is 2 mA RMS. per cm². With the
rubber electrodes this requirement is automatically met, as the output current of the stimulator is limited to
50 mA RMS. With smaller electrodes, such as the 3.2 mm self adhesives, this is not the case. To verify
that the maximum permissible current density of 2 mA RMS. per cm² is not exceeded, divide the RMS
output current in mA by the effective electrode area in cm²: A value of less than 2 should result. For
asymmetrical TENS currents the RMS value of the output current can be calculated as follows:
For symmetrical TENS currents, the Phase duration should be multiplied by 2. The value of the peak
current Ipeak can be taken from the current display.
Note that placement of the electrodes should be done with care. The electrodes should be fixated firmly
carefully and solidly, and that the use of small electrodes in combination with high current amplitudes may
cause skin irritations or burns.
This device has Constant Current (CC) output characteristics, that may cause unpleasant connection and
disconnection reactions if the electrodes are not securely placed or lose contact with the skin. Make sure
the output is set to 0 mA when you apply or remove the electrodes.
8 Operating Instructions
8.1 Operator Controls
hCAUTION:
Connection of accessories other than the ones specified by the manufacturer can adversely affect the
safety of the patient and correct functioning of the equipment, and is therefore not permitted.
The TensMed 931 has an intelligent intensity adjustment to minimise delay in waiting for the next work
period, and to avoid confusing the sensation from the two channels.
When either intensity button is pressed, the work/rest cycle is interrupted, and the other channel intensity
drops to zero. You can then set the intensity required. After you have finished setting, the intensity will
remain at the set level for 4 seconds, then both channels will begin the next rest period.
In Program H only, The TensMed 931 has a high intensity setting, extending output intensity range to
90mA into 1kOhm if this is required.
The first 2 presses of the Intensity button increase the output by about 6V. Thereafter each press of the
Intensity button changes intensity by about 1V in normal mode and 2V in high output mode.
If the Intensity button is held down > 0.5 sec it starts to scroll at two steps per sec (22 seconds to full
scale). If it is held > 2 seconds it scrolls at fivesteps per sec. When it is released it reverts to single steps.
If the unit is accidentally switched on and no other button is pressed within the next 5 minutes, the unit will
automatically switch off.
8.5.1 Programs
The choice of program depends on the results you wish to achieve.
Programs A to F produce a combination of tingling or pulsing/ tapping sensations associated with muscle
contractions. In NMS a period of muscle contraction (Work) is alternated with a period of rest.
Programs R, S and T are TENS programs.
In program S, the output is Continuous. Intensity should be set so that there is a strong tingling feeling
WITHOUT muscle contraction. Program S can be used until the pain relief effect starts to wear off – up to
2 hours.
In program T the stimulus is delivered in bursts: i.e. a group of pulses rather than a single pulse. You
should set intensity so that muscle contractions just start to appear, and use for not more than 60 mins.
Programs G & H (plus S & T for TENS) allow the Medical Advisor or patient to select precisely the NMS
mode settings desired.
Frequency (Hz): 1, 2, 3, 4, 5, 10, 12,14, 16, 18, 20, 25, 30, 40, 45, 50, 60, 70, 80, 90, 100. (Limited
to 50Hz in Prog H)
Depending upon the muscle group and the patient’s status, treatment by NMS can vary from 15 to 60
minutes stimulation twice a week to treatment several times per day.
• Repeat process to set Down Ramp, the time in which intensity decreases from set level to zero.
Repeat again to select Rest Time, the time when intensity is zero.
• If Alternating is selected, the final choice is not L1 Rest Time, but L2 Rest Time. In Alternating
mode, this is BOTH the rest Time for each channel AND the delay between the start of Ch1
Ramp Up and Ch2 Ramp Up.
• If L2 is set at less than (Work time + Ramp Up + Ramp Down) an ERR! message will appear and
the menu will step back to L1 Ramp Up.
Ch1
L2
Ch2
The TensMed 931 may be set so that patient access is restricted to one program, allowing change of
Intensity and Timer only.
Any manual settings in Programs G, H, S or T will be retained if doctor lock is set. You may therefore
prescribe and lock any TENS setting.
To lock the unit, press the same two keys together and hold for 4 seconds until key symbol appears in the
lower left corner of the display.
To unlock the unit, press the MENU and CH1 INTENSITY DOWN keys together and hold for 4 seconds
until the key symbol disappears from the lower left corner of the display.
When the unit is locked, all values will be saved even if the batteries are removed.
When unlocked, removing the batteries will return all values except Usage Time to default settings.
The TensMed 931 may also be set to give the patient two customised programs to access according to
your instructions. Once parameters for manual programs G & H have been set, they can be protected
from further change by pressing MENU and CH2 INTENSITY DOWN keys together and holding for 4
seconds. If you attempt to change any of these parameters LOC will appear in the Hz display. Repeat to
release locking.
To clean the unit, turn it off. Clean the unit with a damp cloth. Do not use abrasive cleaners. A small
amount of mild household detergent may be used, if desired.
Check the cable regularly for damages and/or bad electrical contact. We advise to keep a spare patient
cable in stock.
The electrodes supplied with the TensMed 931 units are self-adhesive and can be used several times.
Skin must be allowed to breath therefore the electrodes should be removed periodically. When not in use
the electrodes should be placed back onto the clear plastic shield.
The condition of the electrodes does affect conductivity and, consequently, the performance of the unit.
When the electrodes initially lose their adhesive quality it is possible to reactivate the adhesiveness by
applying a fine spray of water. When used on clean skin and stored correctly, electrodes will last for
about 14 days.
The TensMed contains materials that can be recycled and/or are noxious to the environment. Specialized
companies can dismantle the unit and sort out these materials. When you dispose of the unit, first inform
yourself about the local regulations concerning waste management.
Figure A Symmetrical Biphasic Rectangular Waveform. Output current into 1kOhm, maximum setting.
Figure B Rectangular Monophasic Alternating Waveform. Output current into 500 Ohm
Figure C Timing Relationship between L1 and L2 Pulses
11 Technical Specifications