Operating+Manual+for+TENSmed+911+&+931+by+ENRAF+NONIUS

TensMed 911

User Manual

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

[email protected]

www.enraf-nonius.com

Part number: 1427.755-40

December 2002

http://www.enraf-nonius.com/

mailto:[email protected]

Table of Content

1 Product Description..........................................................................................32 Foreword............................................................................................................3

2.1 This manual........................................................................................................................ 32.2 Product liability...................................................................................................................32.3 Limitations of liability..........................................................................................................3

3 Precautionary Instructions...............................................................................44 Intended Purpose..............................................................................................5

4.1 Pain Management (TENS).................................................................................................54.1.1 Indications/Contraindications and Adverse Effects for Pain Management.............................54.1.2 Current Waveform..................................................................................................................5

5 Package Contents.............................................................................................65.1 Standard Accessories........................................................................................................65.2 Optional Accessories..........................................................................................................6

6 Installation.........................................................................................................67 Application of Electrodes.................................................................................7

7.1 Before treatment................................................................................................................77.2 Self-adhesive electrodes....................................................................................................77.3 Electrolytic effects..............................................................................................................77.4 Current density................................................................................................................... 77.5 Connection and disconnection reactions............................................................................7

8 Operating Instructions......................................................................................88.1 Operator Controls...............................................................................................................88.2 Intensity adjustment...........................................................................................................98.3 Safety features...................................................................................................................98.4 Additional features..............................................................................................................98.5 Usage monitor.................................................................................................................... 98.6 Basic Operation..................................................................................................................9

8.6.1 Operation by Program............................................................................................................98.6.2 Programs..............................................................................................................................108.6.3 Manual operation.................................................................................................................10

8.7 Doctor Locking.................................................................................................................108.7.1 Program Locking..................................................................................................................108.7.2 Manual Program Locking.....................................................................................................11

8.8 User Maintenance............................................................................................................118.8.1 Cleaning of apparatus..........................................................................................................118.8.2 Patient cable........................................................................................................................118.8.3 Care of electrodes................................................................................................................11

8.9 End of life......................................................................................................................... 119 Stimulator Output Parameters.......................................................................1210 Illustrations......................................................................................................12

10.1 Asymmetrical biphasic TENS waveform.......................................................................1210.2 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.

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.

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

2.1 This manual

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.

2.2 Product liability

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.

2.3 Limitations of liability

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.

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 Pain Management (TENS)

4.1.1 Indications/Contraindications and Adverse Effects for Pain Management

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.

4.1.2 Current Waveform

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

1427940 TensMed 911

5.1 Standard Accessories

The following accessories are included with your TensMed 911:

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

3444057 EN-Trodes, self adhesive electrode 50x50 mm, 1 set 4 pc.

1427755 User manual TensMed 911

Alkaline AA 1,5 Volts (LR6) Batteries

Carry Pouch

5.2 Optional Accessories

3444056 EN-Trodes, self adhesive electrodes, size 32mm Ø, 1 pack = 10 sheets of 4 pc3444135 EN-Trodes, self adhesive electrodes, size 50mm Ø, 1 pack = 10 sheets of 4 pc

3444143 EN-Trodes, self adhesive electrodes, size 70mm Ø, 1 pack = 10 sheets of 4 pc3444057 EN-Trodes, self adhesive electrodes, size 50x50mm, 1 pack = 10 sheets of 4 pc3444058 EN-Trodes, self adhesive electrodes, size 50x90mm, 1 pack = 10 sheets of 4 pc3444146 EN-Trodes, self adhesive electrodes, double lead, size 50x100mm, 1 pack=10 sheets of 2pc

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.

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. 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).

Attach Electrodes to leads:Remove electrodes from the bag and connect to the leads. Simply push the plug on the electrode pigtail into the socket on the lead.

7 Application of Electrodes

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.

NOTE:

The description below applies to electrotherapy applications in general. The electrolytic effects mentioned do not apply to the Tensmed 911 as this device only generates fully balanced TENS currents, that do not contain a DC component.

7.1 Before treatment

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.

7.2 Self-adhesive electrodes.

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.

7.3 Electrolytic effects

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:

IRMS = Ipeak √ ( Phase duration [µs] * pulse frequency [Hz] * 10-6 )

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.

7.5 Connection and disconnection reactions

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

M EN U

- L1 + - L2 +3

1

6

7

8 5

4

2

[1] On / off button.

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.

[2]+[6] Setting button

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.

[3] Adjustment buttons for the Amplitude in channel 1

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

[4] Adjustment buttons for the Amplitude in channel 2

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

[5] Menu / Pause button

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:

Waveform, Frequency, Pulse Width, Constant or Burst, Timer

The PAUSE 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

[7] KEYBOARD LOCK( ( Ñ )

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

[8] PROGRAM SELECTOR ( )

The unit has 9 pre-set programs A,B,C,D,E, F, G, H, I, M and N

The program M and N is for manual adjustment and allows to set Frequency, Pulse width, Constant, Burst and Time.

Details of the programs are shown below.

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

h CAUTION:


8.2 Intensity adjustment

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.

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)

8.3 Safety features

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

8.4 Additional features

The TensMed 911 unit has the following special features:

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.

8.5 Usage monitor

USAGE MONITOR (For Professional Use)

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.

8.6 Basic Operation

8.6.1 Operation by Program

pre-set programs, identified by the letters A through to I. A manual setting, identified by the letter M and N, where the user may select the constant or

burst mode and the frequency and pulse width.

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

A Tingling

Pins & Needles

Most types of

acute and chronic pain

B Pulsing

&

Tapping

Chronic pains such as

backpain, arthritis, rheumatism.

Avoid use on traumatised muscles

C Pulsing

&

Tapping

Chronic pain such as

backpain, arthritis, rheumatism.


D Tingling,

Pins

& Needles

Most types of

acute and chronic pain

but especially menstrual pain

E Pulsing

&

Tapping

Chronic pain, nausea,

travel and morning sickness.


F Pulsing

& Tapping

Most types of acute and chronic pain

G Varies Acute and chronic pain

H Varies Acute and chronic pain

I

Varies Acute and chronic pain

M

Depends on settings Acute and chronic pain

N Depends on setting Acute and chronic pain

8.6.3 Manual operation

8.6.3.1 Setting Manual Parameters Press the program key and select PROGRAM m Press the Menu key during 3 seconds and 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.

8.6.3.2 Setting Treatment Time The Preset Programs are all set with continuous treatment time. To alter this default setting; Press Menu key, C 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.

8.7 Doctor Locking

The TensMed 911 has two levels of Doctor Locking:

8.7.1 Program Locking

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.

8.7.2 Manual Program Locking

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. 8.8 User Maintenance

8.8.1 Cleaning of apparatus

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.

8.8.2 Patient cable

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

8.8.3 Care of electrodes

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.

9 Stimulator Output Parameters

Wave form Biphasic asymmetrical TENS

Pulse Width 50, 100, 150, 200 and 250 µs

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

Frequency modulation Program I, 20Hz to 100 Hz and back in 12 seconds

Program M, 1Hz to 150Hz

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

Burst 2 Hz (0,25 seconds at 100Hz)

Amplitude 0 – 90 mA

Treatment time 10 – 20 – 30 – 45 – 60 minutes and Constant

10 Illustrations

t Pulse width fp Pulse frequency

10.1 Asymmetrical biphasic TENS waveform

10.2 Asymmetrical biphasic burst TENS waveform

fB Burst frequency

11 Technical Specifications

: This equipment complies with all requirements of the Medical Device Directive (93/42/EEC).

Medical device classification : IIaSafety 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 gram, included batteries

Environmental conditions for transport and storage

Temperature : -10° to +50° CRelative humidity : 10 to 100 %Atmospheric pressure : 500 to 1060 hPa

Environmental conditions for normal use

Temperature : 10° to 40° CRelative humidity : 10 to 90 % non condensingAtmospheric pressure : 500 to 1060 hPa

Technical modifications reserved

TensMed 931

User Manual

Copyright:Enraf-Nonius B.V. P.O. Box 2600 AV DELFT The Netherlands Tel: +31 (0) 15 – 26 984 00Fax: +31 (0) 15 – 25 61 [email protected] Part number: 1427.754-40December 2002

http://www.enraf-nonius.com/

mailto:[email protected]

Table of content

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


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



8.6 Doctor Locking 8.6.1 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. 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. 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. 2.2 Product liability 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. 2.3 Limitations of liability 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

4.1.1 Indications/Contraindications and Adverse Effects for Muscle Stimulation

Indications:

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.

Contraindications:

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:

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:

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 (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.

5 Package Contents 1427950 TensMed 931 5.1 Standard Accessories The following accessories are included with your TensMed 931: 3444001 Electrode cable 2mm, 2 pc in conformity with FDA CFR 8983444058 Self adhesive electrode 50x90 mm, 8 pc.1427754 User manual TensMed 931 Alkaline AA 1,5 Volts (LR6) Batteries Carry Pouch 5.2 Optional Accessories 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 pc3444057 Self adhesive electrodes, size 50x50mm, 1 pack = 10 sheets of 4 pc3444058 Self adhesive electrodes, size 50x90mm, 1 pack = 10 sheets of 4 pc3444146 Self adhesive electrodes with double lead, size 50x100mm, 1 pack = 10 sheets of 2 pc

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.

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. 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). Attach Electrodes to leads:Remove electrodes from the bag and connect to the leads. Simply push the plug on the electrode pigtail into the socket on the lead.

7 Application of Electrodes

hCAUTION:


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.

7.1 Before treatment

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.

7.2 Self-adhesive electrodes. 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. 7.3 Electrolytic effects 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:

IRMS = Ipeak √ ( Phase duration [µs] * pulse frequency [Hz] * 10-6) 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. 7.5 Connection and disconnection reactions 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

[1] On / off button. 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.

[2]+[6] Setting button 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. [3] Adjustment buttons for the Amplitude in channel 1Use this button to adjust the current amplitude in channel 1. [4] Adjustment buttons for the Amplitude in channel 2Use this button to adjust the current amplitude in channel 2. [5] Menu / Pause buttonThe MENU 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 PAUSE 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 [7] KEYBOARD LOCK( ( Ñ )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. [8] PROGRAM SELECTOR ( )The unit has 7 pre-set programs A,B,C,D,E, F and R (TENS)2 Manually selectable programs G & H2 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.

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. 8.2 Intensity adjustment 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. 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) 8.3 Safety features

If the unit is accidentally switched on and no other button is pressed within the next 5 minutes, the unit will automatically switch off. 8.4 Additional features The TensMed 931 unit has the following special features:

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.

8.5 Basic Operation

8.5.1 ProgramsThe 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 ProgramDuration

[min]A 10 300 1 1 30 32 15 20B 20 250 1 1 5 7 5 20C 50 250 1 1 5 7 10 20D 75 250 1 1 5 7 15 20E 20 100 1 1 5 7 10 20F 50 100 1 1 5 7 10 20G X X X X X X XH 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 ContinuousT 110 50 Burst 2Hz Continuous


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. 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: 10,2030, 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

8.5.3.1 Setting Manual Parameters 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.

8.5.3.2 Setting Treatment Time

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. Setting Work/Rest Periods

Advance Menu to Synch. Select Synchronous or alternating (See Alternating below) On next increment, the work/rest diagram appears.

L1

1.00sec 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.

Ch1

L2

Ch2 8.6 Doctor Locking The TensMed 931 has two levels of Doctor Locking:

8.6.1 Program Locking

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. 8.7 User Maintenance

8.7.1 Cleaning of apparatus

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.

8.7.2 Patient cable

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

8.7.3 Care of electrodes 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. 8.8 End of life 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.

9 Stimulator Output Parameters Wave form Biphasic Rectangular, Rectangular AlternatingPulse Width 20 – 350 µsPulse 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 sAmplitude 0 – 90 mA Treatment time 10 – 20 – 30 – 45 – 60 – 90 minutes and continuous

10 IllustrationsWAVEFORMS

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

: 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 storageTemperature :-10° to +50° CRelative humidity :10 to 100 %Atmospheric pressure :500 to 1060 hPa Environmental conditions for normal use Temperature :10° to 40° CRelative humidity :10 to 90 % non condensingAtmospheric pressure :500 to 1060 hPa Technical modifications reserved