Enraf Nonius TensMed 931 User manual

Brand: Enraf Nonius

Model: TensMed 931

Type: User manual

7HQV0HG

User Manual

P.O. Box 12080

3004 GB Rotterdam

The Netherlands

Tel: +31 (0) 10 – 20 30 600

Fax: +31 (0) 10 – 20 30 699

info@enraf-nonius.com

www.enraf-nonius.com

Part number: 1427754_41

August 2005



7HQV0HG

Operating Instructions

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Table of content

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2.1 This manual ........................................................................................................................ 4

2.2 Product liability.................................................................................................................... 4

2.3 Limitations of liability........................................................................................................... 4

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4.1 Muscle Stimulation..............................................................................................................5

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 &XUUHQW:DYHIRUP 

 3DFNDJH&RQWHQWV

5.1 Standard Accessories......................................................................................................... 7

5.2 Optional Accessories .......................................................................................................... 7

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7.1 Before treatment ................................................................................................................. 8

7.2 Self-adhesive electrodes..................................................................................................... 8

7.3 Electrolytic effects............................................................................................................... 8

7.4 Current density.................................................................................................................... 8

7.5 Connection and disconnection reactions............................................................................ 8

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8.1 Operator Controls ...............................................................................................................9

8.2 Intensity adjustment.......................................................................................................... 10

8.3 Safety features.................................................................................................................. 10

8.4 Additional features ............................................................................................................ 10

8.5 Basic Operation ................................................................................................................ 10

 3URJUDPV  

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8.6 Doctor Locking..................................................................................................................12

 3URJUDP/RFNLQJ

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8.7 User Maintenance............................................................................................................. 13

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 &DUHRIHOHFWURGHV 

8.8 End of life.......................................................................................................................... 13

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 7HFKQLFDO6SHFLILFDWLRQV 



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 3URGXFW'HVFULSWLRQ

The TensMed 931 is a 2-channel electrotherapy apparatus, that is optimized for muscle stimulation

applications, using symmetric TENS current waveforms.

The apparatus provides both protocol driven and manual operation.

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.

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 )RUHZRUG

 7KLVPDQXDO

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.

 3URGXFWOLDELOLW\

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.

 /LPLWDWLRQVRIOLDELOLW\

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.



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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.

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• 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.

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• 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.

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• Relaxation of muscle spasms.

• Prevention or retardation of disuse atrophy.

• Increasing local blood circulation.

• Muscle re-education.

• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

• Maintaining or increasing range of motion.



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• 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

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• 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.

3UHFDXWLRQV

• 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.

$GYHUVH(IIHFWV

• Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic

electrical stimulation.

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Muscle stimulation (ameliorating muscle dysfunction):

• Neuromuscular Electrical Stimulation (NMES) is the use of electrical stimulation for activation of

muscle through stimulation of the intact peripheral nerve.

• Functional Electrical Stimulation is the use of NMES for orthotic substitution.

• Electrical Muscle Stimulation (EMS) is the use of electrical stimulation for direct activation of

denervated muscle.

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.



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1427950 TensMed 931

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The following accessories are included with your TensMed 931:

3444001 Electrode cable 2mm, 2 pc in conformity with FDA CFR 898

3444058 Self adhesive electrode 50x90 mm, 8 pc.

1427754 User manual TensMed 931

Alkaline AA 1,5 Volts (LR6) Batteries

Carry Pouch

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3444056 Self adhesive electrodes, size 32mm Ø, 1 pack = 10 sheets of 4 pc

3444135 Self adhesive electrodes, size 50mm Ø, 1 pack = 10 sheets of 4 pc

3444143 Self adhesive electrodes, size 70mm Ø, 1 pack = 10 sheets of 4 pc

3444057 Self adhesive electrodes, size 50x50mm, 1 pack = 10 sheets of 4 pc

3444058 Self adhesive electrodes, size 50x90mm, 1 pack = 10 sheets of 4 pc

3444146 Self adhesive electrodes with double lead, size 50x100mm, 1 pack = 10 sheets of 2 pc

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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.

Use only AA Alkaline 1.5 volt batteries (LR6).

Do not mix old and new batteries.

The battery contains material that is noxious to environment. You should attend the local regulations

when disposing the battery.



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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).

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Remove electrodes from the bag and connect to the leads.

Simply push the plug on the electrode pigtail into the socket on the lead.

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&$87,21

• 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.

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• 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.

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• 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.

 6HOIDGKHVLYHHOHFWURGHV

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.

 (OHFWURO\WLFHIIHFWV

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.

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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:

IRMS = Ipeak ¥ ( Phase duration [µs] * pulse frequency [Hz] * 106 )

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.

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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.

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3 4

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1 7

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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.

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Allows you to adjust the setting of each Parameter selected in Menu.

When you are satisfied with the setting, press the Menu key again to save it.

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Use this button to adjust the current amplitude in channel 1.

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Use this button to adjust the current amplitude in channel 2.

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The 0(18 function accesses only the Timer when preset programs have been selected.

When programs G,H,S or T are selected, it allows you to set all NMS and TENS parameters manually.

Parameters that can be selected are:

Waveform, Frequency, Pulse Width, Ramp Up, Work Time, Ramp Down, Rest Time,

Synchronous/Alternating/ Timer

The 3$86(function interrupts a Program which is using the Timer.

It only operates when a program is running, with Intensity >0.

Hold down for 2 seconds to Pause.

Hold down again for 2 seconds to Resume.

When you resume the program the intensity resets to level 1 and the timer symbol flashes until the

intensity button is pressed

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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.

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The unit has 7 pre-set programs A,B,C,D,E, F and R (TENS)

2 Manually selectable programs G & H

2 Manually selectable TENS programs S & T.

Details of the programs are shown below.

When the unit is switched on, it will show the last program used.

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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.

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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 five steps per sec. When it is released it reverts to single steps.

The bar graph on the LCD shows the intensity selected.

The first segment lights as soon as intensity is above zero.

Each subsequent segment represents approx 4.5V (6 V in high intensity mode)

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

If the unit is accidentally switched on and no other button is pressed within the next 5 minutes, the unit will

automatically switch off.

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The TensMed 931 unit has the following special features:

• 6281'When the unit is switched on an audible beep will be emitted. When the unit is switched

off there will be two audible beeps.

• 212))/,*+7: When the unit is on the LED light will light up. The light is located at the front of

the unit.

• /2:%$77(5<:$51,1*There is a low battery detector in the unit. The LCD screen will flash

the symbol of a battery when the batteries need replacing.

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The choice of program depends on the results you wish to achieve.



Program Pulse

frequency

[Hz]

Phase

duration

[µs]

Ramp

On in

[s]

Ramp

Down

[s]

Plateau

[s] Total

Work

[s]

Rest

[s] Default

Program

Duration

[min]

A 10 300 1 1 30 32 15 20

B 20 250 1 1 5 7 5 20

C 50 250 1 1 5 7 10 20

D 75 250 1 1 5 7 15 20

E 20 100 1 1 5 7 10 20

F 50 100 1 1 5 7 10 20

G X X X X X X X

High

Intensity

Max 50 X X X X X X

R 20-100 100 Frequency modulates from 20Hz to

100Hz and back in 12 secs Continuous

S 110 50 Continuous

T 110 50 Burst 2Hz Continuous



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Programs $ to ) 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.

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Programs *+SOXV67IRU7(16 allow the Medical Advisor or patient to select precisely the NMS

mode settings desired.

Selections available are:

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)

N.B.: Frequencies 6, 7 and 8 Hz have been excluded.

Pulse Width (µs): 20, and 50 – 350 in 50 µs steps.

Waveform: biphasic rectangular, Rectangular unipolar, alternating.

Treatment time: 10,20 30, 45,60, 90 minutes or continuous

Synch: Alternating/Synchronous between Ch1 and Ch2

Ramp Time: 0-5.0 seconds in steps of 0.25 seconds

Work time: 1-60 seconds in steps of 1 second

Rest time: 0-99 seconds in steps of 1 second

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• Press the Menu key. The Hz display will start to flash.

• Use Menu +/- keys to adjust to the desired setting.

• Press the Menu key to confirm the change and go to the next parameter.

• After setting Timer, no parameters flash and settings are saved. If you only wish to change one

parameter, you can confirm the settings and escape from the Menu by increasing Intensity above

zero. If no key is touched for 6 seconds the settings will be saved and the unit exits Menu.

 6HWWLQJ7UHDWPHQW7LPH

• The Preset Programs are all set with a default treatment time of 20 minutes.

• To alter this default setting;

• Press Menu key, 20 min symbol will flash.

• Use Menu -/+ Keys to adjust to new desired setting.

• Set to C (Continuous) if no Timer function is required.

• Press Menu key to confirm setting and exit.

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.



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• Advance Menu to Synch. Select Synchronous or alternating (See Alternating below)

• On next increment, the work/rest diagram appears.

/

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• The Up Ramp and Time Flash.

• Use Set key to select the time in which intensity increases from zero to set level.

• Repeat process to set Down Ramp, the time in which intensity decreases from set level to zero.

• Repeat again to select Work Time,

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.

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The TensMed 931 has two levels of Doctor Locking:

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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 3URJUDPV*+6RU7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.

 0DQXDO3URJUDP/RFNLQJ

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.



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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.

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Check the cable regularly for damages and/or bad electrical contact. We advise to keep a spare patient

cable in stock.

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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.

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The TensMed contains materials that can be recycled and/or are noxious to the environment. Specialized

companies can dissemble the unit and sort out these materials. When you dispose of the unit, first inform

yourself about the local regulations concerning waste management.

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Wave form Biphasic Rectangular, Rectangular Alternating

Pulse Width 20 – 350 µs

Pulse frequency 2 – 100 Hz

Surge mode SYNC – ASYNC between channel 1 and 2

• Ramp up / down 0 – 5 s in steps of 0.25 s

• Work time 0 – 60 s in steps of 1 s

• Rest time 0 – 99 s in steps of 1 s

Amplitude 0 – 90 mA

Treatment time 10 – 20 – 30 – 45 – 60 – 90 minutes and continuous

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)LJXUH$Symmetrical Biphasic Rectangular Waveform. Output current into 1kOhm, maximum setting.

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)LJXUH% Rectangular Monophasic Alternating Waveform. Output current into 500 Ohm



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

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

)LJXUH& Timing Relationship between L1 and L2 Pulses 



PULSE

WIDTH

POSITIVE

AMPLITUDE

PULSE

WIDTH

AMPLITUDE

NEXT PULSE, INTERVAL

DEPENDS ON HZ

SETTING

POSITIVE



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: This equipment complies with all requirements of the

Medical Device Directive (93/42/EEC).

Medical device classification : IIa

Safety tests : according to IEC 60601-1 +A1 +A2 and IEC 60601-2-10

+A1,

Safety class according to IEC 60601-1 : type BF

Dimensions : 144 x 80 x 27,5 mm (h x w x d)

Weight : 180 gr. (incl. Batteries)

Environmental conditions for transport and storage

Temperature : -10° to +50° C

Relative humidity : 10 to 100 %

Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use

Temperature : 10° to 40° C

Relative humidity : 10 to 90 % non condensing

Atmospheric pressure : 500 to 1060 hPa

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

Enraf Nonius TensMed 931 User manual

Enraf Nonius TensMed 931 User manual

Enraf Nonius TensMed 931 User manual

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