Vitatronic Digital EMS/TNS User guide

Instruction
.......drugfree pain management !
Version 2.1 MPG
VITAtronic
®
Digital EMS/TNS
.... easy, secure
and relaiable !
Copyright Ostimex GmbH
©
Carefully read this
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Content
1. Security instruction
page 2
2. General instruction page 3
3. Take care instruction page 4
4. Buttons and Display page 5
5. Before using page 6
6. Using the device page 7
7. Indications page 8
8. Contra-indications page 9
9. Samples of use pages 10 - 20
10. Warnings pages 21 - 23
11. Guarantie and cleaning instruction page 24
12. Technical specification pages 25 - 30
13. Accessories page 31
14. Notes / Literature tips page 32
15. Additional TENS/EMS applications page 33
16. How to use the electrodes/pads page 34
17. Address / Service page 35
1. Security instruction
The VITAtronic Digital EMS/TNS is a digital and modern therapeutical transcutanes nerve stimulator, delivering electrical pulses by electrodes at and through the skin. Basis for this are in the meantime recognized procedures, with which it comes to the stimulation of certain nerve and muscle portions and which as so-called pain therapy and therapeutic muscle stimulation admits are.
The equipment was conceived for these applications, therefore it should be used with ambiguity after instruction of the physician or therapist only.
Read the instruction carefully, so that desired successes adjust themselves and no application errors arise.
Special supervision applies, if the equipment is to be used with children; groups of risks, as e.g. pacesetter patients, chronically patient and pregnant woman must ask your physician before use the therapy and the device.
2. General instruction
TENS (Transkutane Electrical Nerve Stimulation)
The transcutane electrical nerve stimulation is a very effective and safe treatment of pain.
The effect of the therapy was examined in large clinical studies and for more than 20 years in many countries worked satisfactorily.
Even when illnesses with pain existing for a long time it can often still be obtained another good pain elimination. It could be proven that by TENS body-own pain-switching off systems are activated to stop pain information into the brain.
3. Precautions
When the device may not or only be used in arrangement with the treating physician/therapist?
at patients with electrical implants (cardiac pacemakers)  together with metallic implants within the attraction current range  at patients with heavy heartbeat disturbances  at patients with attack-ailments  in pregnancy period  at skin changes under the electrodes  with neuritises and manifest thromboses
Except skin incompatibilities with the electrode material, contact- or adhesive gel and isolated skin irritations no side effects are notified with the application. Stimulation is not allowed while driving a car or at work on machinaries. Remove electrodes/pads before taking a shower or swimming and do not use electrodes with constant direct current. Do not place electrodes/pads on hurt skin. If any skin irritation occur the treatment must be stoped immediately and a physician must be consulted for further action and advise!
4. User controls
Clip
Display
Mode / Program selection
Timer
CH1 Intensity
ON/OFF
CH2 Intensity
Frequency, pulse width, timer selection (+/-)
Battery
compartment
5. Preparation (before using the device)
Insure yourselve before application that your EMS/TNS device is equipped with the necessary batteries (included in the package). The batteries are inserted into the battery compartment considering the correct polarity (+/-). To open put the clip off and simply slide the cover away in direction of arrow marking on the battery compartement cover.
Before the attachment of the electrodes the skin must be cleaned in particular from cream and fat arrears.
Connect on the electrode cables with the electrodes and put the cable into the device (top side) before switching on. Take the electrode off (if it concerns a sticking/detention electrode) the protective plastic film and stick it on the appropriate or advised part of the body or the application aera. The equipment is now ready to use and can be switched on. Later when switching on again automatically the latest therapy and function selected is restored except the intensity. The intensity must be adjusted after each application and shut down again.
6. Use and applications
After finishing the preparations you can now use your EMS/TNS stimulator for therapeutic purposes. Select the therapy program you need or wish to use by pressing the MODE button. By repeated pressing of this button (page through) an overview of all adjustment possibilities is shown on the display. The selection offers different firmly fixed therapy programs and individually adjustable parameters - details for parameters to change is stated in section technical specification.
Normally your physician/therapist selects a program suitable for you and/or adjusts the equipment to the necessary therapy program for your special indication or disease. The intensity is selected in such a way that the impulses are to be felt strong but still pleasantly - with the intensity buttons this can be made separately and individually for each of the two channels. With the belt-clip your equipment is usable also for the mobile use.
7. Indication
Pain therapy:
Arthralgia (pain in the joints) Headache Neuralgia (pain in nerves) Muscle skeleton pain Scar pain Menstruation pain Post-operational pain Polyneuropathien Rheumatism complaints and pain Back pain Shoulder arm syndrome Stump pain Phantom pain Groin pain Pain therapy with tumor patients Post-operative intervertebral disk complaint and pain
For the muscle stimuation:
Muscle building/muscle strengthening ISO-metric muscle training Prevention of muscle contractuures Spasti paralyses Atrophy, degeneration prophylaxsis Destorsions Instabilities of joints Conservative scoliosis therapy Incontinence Contusions
Further applications:
Arterial problems of the extremities (pertaining to an artery) Activation of blood circulation Thrombotic prophylaxse
8. Contra-indications
The treatment should not be accomplished/continued or after consultation and advise with the physician or therapist only
in case of:
- Pregnancy
- Person with cardiac pacemaker
- Simultaneous use with high frequency surgery devices or defibrillation
- Metal implants in the electric application circuit
- Bacterially inflammations under the electrodes
- Swelling/redness of the skin caused by infection or injury
- Acute neuritides
- Malignant or malignome-suspicious skin changes in the applcation eara
- Manifested thrombosis
- Heavy heartbeat disturbances
9. Treatments
TENS - Application
Sciatica pain
lumbago
Sinew swelling or
inflammation on hand and finger
extensors
Pain in the back
intervertebral
disc pain
TENS - Application
Tennis ellbow
(Epicondylopathy)
Outside meniscus
demage and pain
arthrosis
capsule irritation
Kneecap pain
knee arthrosis
(chondroppathia patellae)
Splayfoot
rheumatism foot
TENS - Application
Sinew irritation
or swelling of the
hand and finger
flexor
Golfers elbow
Shoulder arthrosis
shoulder pain
capsule irritaion
TENS - Application
Pain in the lower
part of the belly
mentruation pain
fallopian tube pain
Pain in the
bile and liver area
TENS - Application
Hip pain
hip arthrosis
Neck and
shoulder pain
Pain between
the shoulder blades
EMS - Application
Fig. 13 Fig. 14
EMS - Application
Fig. 11 Fig. 12
EMS - Application
Abb. 15 Abb. 16
10. Warnings
Auxiliary references according to the MDD (medical device directive)
The manufactur, assembler or importer expresses its responsibility only for security, reliability and correct function of the devices, if: Assembly, extension, new adjustment/modification, changes or repairs through or by authorized persons to be implemented and the device is used according with the operating instruction.
Warning references (for commercial use only)
Simultaneous connection of the patient to high frequency surgery equipment can entail burns under the attraction current electrodes. The use/application of the device close (e.g. 1 m) to a short frequency unit or microwave unit can cause fluctuations of the initial values of the attraction current equipment.
Technical control (applies to commercial use only) according to MDD (medicical device directive) and/or MPBetreibV
Every 24 months technical controls for the device are to be accomplished, cover in detail the following:
1. Control for presence of the operating instructions and the medicine product or equipment book.
2. Check for completeness of the equipment (equipment and accessories).
3. Visual check on mechanical damages equipment and the accessories.
4. Functional safety examination of the output signals the frequency and the pulse width.
Technical controls may be accomplished by trained persons only and the result and the control should be noted in the medicine product or equipment book with date and name of the implementing person.
Battery disposal/equipment disposal
Make a contribution to environmental protection; used up batteries and accumulators may not into the domestic refuse. They can be delivered with a collecting point for used batteries and/or special refuse. Details you will get from your comunity. After the life of the equipment you dispose this please in the recycling center of their municipality, disposal references find you on the back of the equipment; They can give/back send the equipment also back to us we provide for a correct utilization.
Serial number/year of production
In the battery case is laterally a label with the serial number of the equipment, the first two numbers indicates the year of production; thus a serial number 01/0756 e.g. means that the equipment was manufactured in the year 2001 and a serial number is 0756.
11. Guarantee / Cleaning
Cleaning and care
Clean all plastic parts only with a damp cellulose - never use scrubbing means, solvents or gasoline! The equipment display may wiped only with water by gentle to be cleaned (pressure on the display has to be avoided - danger of fracture!!). The equipment requires (battery changes excluded) no special maintenance or service.
Declaration of guarantee (D)
We grant 1 year warranty, as far as legal regulations do not prescribe different guarantee periods. The warranty is valid starting from the time of the assumption/the purchase or the first use. The equipment display is excluded from the warranty, if an error or a damage is not lodged a complaint immediately after receipt/employment. Accessories such as cables or electrodes are subject to the normal wear and are excluded from the warranty.
12. Technical specification
Display and buttons
Display of the therapy (TENS)
Display of frequency and pulse width
Display of the programs (modulation, burst or constant)
Preselected programs: Burst I und II, Modulation I und II, Recp I und I; mixed frecueny, strength duration
Channel I and II, Timer, Low battery indicator, Memory
The above sketch also shows (left and right hand side) the intensity indication for channel I/CH1 and channel II/CH2 (min. 2 und max. 20)
ON / OFF
Mode
Intensity down
Parameter set: Frequency / Pulse width / Timer
Selectable parameters: Frequency / Pulse width / Timer
Intensity up
Memory functions
Display / How to get/control the stored information
a) The following paramters are stored into the memory before shut
down the device: Selected programe, pulse width and frequency (For safety reasons the intensity is not stored and must be switch at propriate level every time!)
b) Storage of the time used (kumulativ)
(therypy control)
Button combination +
Both buttons must be hold at the same time !
No memory function are sstored without/or change of batteries !
Reset / 00 +
Technical specification:
Unit/type: TENS/EMS-combination (dual-channel) Output Intensity: 0-50V - 20 selectable levels (across 500 Ohm) with TENS
Frequencies: 47 selectable frequencies
Pulse widths: 9 selectable pulse widths (Programe CONST only)
Pulse form: Symmetric mono-phasic rectangular pulse (with TENS)
Programs: Program choices for 8+1 Therapy programs
0-65V - 20 selectable levels (across 500 Ohm) with EMS 0-98mA (across 500 Ohm)
1, 2, 3, 4, 5, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 28, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 120, 130, 140. 150, 160, 170, 180, 190 and 200 Hz
50, 75, 100, 125, 150, 175, 200, 225 and 250 µs or fixed at 150 µs (with TENS-programs)
Symmetric bi-phasic rectangular pulse (with EMS)
Const-program free selectable (frequency-pulse width-intensity) Burst I  2 bursts per second and each burst with 7 pulses Burst II  2 bursts every 2 seconds and every burst with 80 pulses Modulation I  pulse width modulates between 50  250 µs, Ramp up for 6 seconds and Ramp down for 6 seconds.
Technical specification:
Programs: Modulation II Frequency modulates with permanent change of direction
down from 100Hz to 20Hz within 6 seconds and up from 20Hz to 100Hz within another 6 seconds.
EMS Modes Hz µs Ramp Up ON time Ramp Down OFF time
Cycled I 30 400 5 sec 20 sec. 5 sec. 10 Sec.
Cycled II 55 400 5 sec 30 sec. 5 sec. 20 Sec.
Reciprocal I 30 400 5 sec 20 sec. 5 sec. 20 Sec.
Reciprocal II 55 400 5 sec 30 sec. 5 sec. 30 Sec.
Timer: Continues and 5 times selectable (automatic shut down)
Permanent, 10 min., 15 min., 30 min., 45 min., 60 minutes.
Classification: Type of protection against electric shock: Internally powered equipment Degree of protection against electric shock: BF applied part Degree of protection against harmful ingress of water: Ordinary equipment Mode of operation: Continuous operation
Technical specification:
Battery: 2 x 1.5V AA batteries (Typ LR6 or R6G)
Transport&Storage: Temperature 10°C to 40°C Conditions: Air humidity 30% to 75%
Weight: 90 g (without batteries) Dimension: 90 x 65 x 30 mm
Atmospheric pressure 700 hPa to 1060 hPa
Additional function: Memory of the lateast selection (without intensity).
Time memory: Storage of the used time (max. 0-99 hours) and reset. Display: Display of all selectable funktions and low battery status. Autom.shut down: Intensity level 0 on each channel for more than 5 minutes
Low battery control: Low battery symbol Intensity shut down: In case the electrodes/pads measure non skin resistance the
Timer counts back to 0 shut down the device.
will shut down the device automatically.
intensity level shut down automatically to 0 and can be
Pulse forms (dual channel)
(C) Constant
Frequeny range 2-120 Hz Pulse width range 2-100 µs
(B) Burst
Frequeny 2 bursts/sec. each burst 80 pulses
(M) Modulation
Frequency modulates 50% up and down every 3 seconds Pulse width modulates 50% up and down every 3 seconds
13. Accessories
For the correct and therapeuttic use the following accessoreis is availbale and can be ordered according to the list below:
Item-No. 355100 - Adhesive pads 40x40 mm Item-No. 355110 - Adhesive pads 50x50 mm Item-No. 355114 - Adhesive pads 40x80 mm Item-No. 355001 - CE pads and lead Item-No. 355009 - Acupuncture clip Item-No. 355004 - Y-connection lead Item-No. 355120 - VITAtronic Adhesive gel (Tube 50 g) Item-No. 355170 - Spare batteries (Satz 2x1,5 Volt) Item-No. 355160 - Re-chargeable batteries and charger
We would like to point out to use original accessories and parts or electrodes/pads as per above list. The original accessories and parts only guarantees the best and effective result of your application and your device.
®
15. Additional TENS/EMS-Applications
Following list to further areas of application became out of physiotherapy, sport-medical and other scientific publications to this range of topics gathered.
Sport medicine i.e.. with sport injuries, pulling, muscle complaints of the entire movement and supporting apparatus, after meniscus OP and/or with complaints and pain of the thighs, the knee joint, the calves and foot joints.
Medicine Complaints and pain in the face or in the jaw2 section, nerve pain, neuralgy, headache, migräne and toothache, with spinal column jokes, HWS/LWS syndrome, after Bandscheiben OP, with joint pain and also e.g. with rheumatism tables complaints.
Gynäkologie Complaints and pain in the birth preparation, post office-operational pain in that birth assistance, menstrual pain and with inkontinence.
Cosmetic application Rationalisation and strengthening of the connective tissue, optical fabric rationalisation, rationalisation of the face musculature, Cellulites, blood circulation promotion and increase of the general well-being.
Everyday life and professional haven Structure of muscle, muscle strengthening, muscle training, to the match preparation and condition preservation and condition increase.
16. How to use the electrodes/pads
17. Address / Service
BF
applied parts
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Ostimex Medizinelektronik GmbH
72178 Waldachtal
Tel.: 07443 / 6111 - Fax: 07443 / 7543
Internet/Homepage:
eMail: Info@ostimex.com
http://www.tens.de
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