Instruction Manual
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TENStem eco basic Transcutaneous nerve and muscle stimulator
Art.-Nr. 200506
Art.-No. 104041
Instruction Manual Art.-No. 100863-V02
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TENStem eco basic
Contents Intended use............................................................................................................3 Safety instructions..................................................................................................3 Symbols...................................................................................................................4 Technical data.........................................................................................................4 Features...................................................................................................................6 Description..............................................................................................................6 Keypad.....................................................................................................................6 Operating the TENStem eco basic..........................................................................7 Setting date and time.............................................................................................8 Memory query mode...............................................................................................8 Resetting the memory.............................................................................................9 Battery change........................................................................................................9 Overview of key combinations................................................................................9 Pre-set programs...................................................................................................10 User programs for own settings...........................................................................15 Examples of electrode placements for pain programs.........................................16 Electrode placement for dynamic stimulation......................................................20 Classification.........................................................................................................22 Settings, modifications and repairs......................................................................22 Guarantee..............................................................................................................22 Maintenance and cleaning...................................................................................22 Delivery content....................................................................................................22 Frequently asked questions..................................................................................23 Accessories...........................................................................................................24 Program overview.................................................................................................26
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TENStem eco basic
Intended use The TENStem eco basic has been designed for the generation of the transcutaneous electrical nerve and muscle stimulation and may not be used for any other purposes.
Safety instruction Please read the operating instructions carefully before using the device! Only use the device with original accessories. Keep the device away from water or other liquids. Do not drop the device, do not use it inappropriately or expose it to extreme temperatures or high humidity (not less than 10 °C or more than 40 °C or a relative humidity of more than 90 %). Do not use the device if it is not working properly or if it has been damaged in any way. Be careful when using the device near or on children. Always store the device in its case to protect it from damage and dust. Caution! Patients with medical implants (e.g. cardiac pacemakers) should consult their doctor before using the TENStem eco basic. The TENStem eco basic may only be connected to one person at any one time. Long treatment sessions are subject to limited periods of time. Do not extend the treatment time of the fixed programs. After a treatment session wait for several hours before using the TENS unit again. Warning! The simultaneous use with a high frequency surgical unit can cause burns underneath the electrodes. The application of the TENS unit close to a shortwave or microwave device can cause variations in the output values of the TENS. In addition, portable or mobile high frequency communication devices may affect the operation of electrical medical devices. The size of the electrodes should not be less than 2 cm².
4 schwa-medico Operating manual - TENStem eco basic
General Information Symbols First read the operating instruction manual.
BF type application part. Protection against electric shocks.
This symbol indicates the year of construction of the product. This symbol indicates the article or order number of the product. The serial number of the product follows this symbol. The letter indicated the series. This equipment is marked with the recycling symbol. You must dispose of it separately at an appropriate collection point and not place it in the normal domestic unsorted waste stream. This will benefit the environment for all. Conformity with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Technical data 2-channel nerve and muscle stimulator with electrically insulated channels, 12 integrated constant current characteristic programs and from series C 3 user programs for own settings. Power supply: Output current: Dimensions: Weight: Output current: Pulse form: Frequency range: Pulse width: Operating conditions:
6.0 V (4 x 1.5 V battery AAA type micro e. g. LR03) or 4.8 V (4 x 1.2 V rechargeable battery AAA) Max. 100 mA (therapy) Approx. 30 µA (power down) Approx. 140 mm x 64 mm x 28 mm Approx. 96 g (without batteries) 0 - 60 mA (with 1 kΩ load) Positive rectangle with negative component Series A & B: 2 - 100 Hz / series C & D: 1 - 120 Hz Series A & B: 75 - 250 µs / series C & D: 75 - 300 µs Temperature range: 10 °C to 40 °C Relative humidity: 30 % to 90 %
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Pulse forms with 1kΩ load Output Power, Voltage
Time
with ANSI/AAMI standard load Voltage
Time Output Power
Time
Change in output current depending on load Output Power I mA 80 60 40 20
500
1000
1500
2000
2500
Resistance RL Ω
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Features - 15 programs (12 pre-set, 3 for own settings) - Large LCD that shows: - Selected program - Therapy time - Intensity (two separated channels) - Frequency - Pulse width - Automatic cut-off after 2 minutes of no use. - Easy handling via keypad - Battery level control - Electrode recognition: the intensity is reduced to 0 if no electrodes are connected or not properly connected. - The selected program can be interlocked. - Saving and read-out of operating parameters. 6
Description All parameters can be adjusted via the keypad and are indicated on the large display. 1. Display 2. Menu keys 3. Modification keys to adjust parameters and intensities 4. ON/OFF key 5. Battery compartment 6. Output sockets for the cables
Keypad
1
4 2
to switch the device on and off and to stop stimulation P to select a program E to set the parameters to increase the intensity (left for channel 1, right for channel 2) to decrease the intensity (left for channel 1, right for channel 2)
3
5
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Operating the TENStem eco basic Starting the device Insert the batteries into the battery compartment (no. 5). Please also read the chapter “Battery change” for more information. All symbols appear automatically on the display. An acoustic signal indicates that the unit is ready for use. Connecting electrodes and cables First connect the 2 mm diameter male connectors of the cables (red and white connector on each cable) to the black female connectors of the electrodes (always 2 electrodes per cable). Connecting the cables to the TENStem eco basic Connect the white plug at the other end of the cable to the sockets on the upper front face of the TENStem eco basic (no. 6). You may use the device with one or two cables depending on the therapy. Switching ON the TENStem eco basic Press to switch ON the TENStem eco basic. A double beep sounds. The display indicates the selected program, the therapy time, the frequency, the pulse width and the intensity. Program
ON/OFF, Stop Selecting a program
Press P until you have selected the program of your choice. Once you have reached P15 you will return to P1. Starting the stimulation / setting the intensities Press the left key to increase the intensity of channel 1. Press the right key to increase the intensity of channel 2. Press the left key to reduce the intensity of channel 1. Press the right key to reduce the intensity of channel 2. It is not possible to adjust the intensity of both channels at the same time.
Intensity Channel 1
Intensity Channel 2
Stopping the stimulation The stimulation stops automatically at the end of each program. You can stop the stimulation manually at any time by pressing the P key or the key. Switching OFF the device Press the key to switch OFF the device. A single beep sounds. The TENStem eco basic switches OFF automatically after 2 minutes if no key pressed.
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Setting date and time (From series C) Before you can use the memory query mode you need to set the date and time. Pressing and holding the E key for about 3 seconds leads you to the date/time mode. In date/time mode the LCD shows two figures: The left figure indicates the date, the right figure indicates the time. Pressing the left key increases the date by one day (max. 30). Pressing the left key decreases the date by one day (min. 1). Pressing the right key increases the time by one hour (max. 23). Pressing the right key decreases the time by one hour (min. 0). Press the key to save all parameters and to leave the date/time mode again. Date and time are continuously updated. The TENStem eco basic switches OFF automatically after two minutes if no key is pressed. In this case none of the adjusted parameters are saved.
Memory query mode (From series C) First set the date and time (see above). The memory query mode is used to read out saved therapy data from patients. By pressing and holding the left and E key for about 3 seconds you enter the memory query mode. If no values are saved, the display shows “null” for about 2 seconds and the device returns to standby mode automatically. If you have saved therapy data, the display shows the parameters of the last therapy session as shown below: -
Used program = P01 Frequency = 100 Hz Pulse width = 200 µs Therapy duration = 0 min 44 s Day of therapy = 5 (fifth day) Therapy session no. = 3
You can save up to 90 therapy sessions respectively the first 3 of each day. With the left key you can return to the values of the previous day (until you reach the first recorded day). The left key lets you proceed to the next day (until you reach the current day). The right key brings you to the parameters of the last therapy session of the respective day (until you reach the first session of the respective day). The right key shows you the parameters of the next therapy session (until you reach the last session of the respective day).
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Resetting the memory Pressing and holding the E button for about 5 seconds will delete all saved data. The display shows “Clr” for about 2 seconds and the device can be used for stimulation again. The TENStem eco basic switches OFF automatically after two minutes if no key is pressed.
Battery change If the battery voltage is less than 3.7 V, the battery symbol appears in the display and it is necessary to insert in 4 new 1.5 V batteries (AAA, e.g. LR03). To change batteries: - Switch OFF the device. - Open the battery compartment on the back side of the device by sliding out the cover. - Remove the old batteries. - Insert the new batteries (check polarity). - Close the battery compartment. If you do not use the device for a longer period of time, always remove the batteries. In case you use rechargeable batteries, please follow the instructions of the charging unit. Please dispose old batteries properly!
Overview of key combinations Interlocking/Unlocking a program Simultaneously press left and P key for 3 seconds Changing stimulation time (From series C) Press E key Setting own programs (From series C) Select P13 - P15, press E key Entering date/time mode (From series C) Press E key for 3 seconds Entering memory query mode (From series C) Simultaneously press left and E key for 3 seconds Switching ON/OFF the sound (From series D) Simultaneously press E key and right for 3 seconds. Press E to change between sound on/off.
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Pre-set programs Program 1: Gate control 1 Both channels work with the same frequency and pulse width. Frequency: Pulse width: Therapy time:
100 Hz 200 μs 30 min (10 to 90 min)
Indications: Acute nerve or joint pain This program is used to treat acute neuropathic and joint pain. The effect is immediate. Intensity ����������
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80 Hz 150 μs 30 min (10 to 90 min)
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Program 3: Low frequency ��
Both channels work with the same frequency and pulse width (see illustration Program 1). ������� � ���� ��� Frequency: �� �� 2 Hz �� Pulse width: 250 μs Therapy time: 30 min (10 to 90 min) ���������� �������� �
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Indications: ������� Diffuse nerve, joint or muscle pain, spasms, lower back pain, neck ��pain, fibromyalgia, chronic pain. This program is used to relax painful muscles and to achieve an endorphin release. Endorphins have ������� lasts beyond stimulation, but you need to run an analgesic effect that ���� � � � program P3 to the end (30� min). To achieve particularly good effects use kaada electrodes placement (on the hand). ����������
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Program 4: Gate control & low frequency The channels work with different frequencies but with the same pulse width. Therapy time 30 min (10 to 90 min) ���������� ������� Channel 1: ������������ Frequency: 100 Hz Pulse width: 200 μs �
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Indication: Joint pain ����� This program combines the effects of program 1 and 3, in case the analgesic effect off program 3 is not strong enough. Intensity ����������
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After��phase ��� 1 the program changes automatically to phase 2. ������� Therapy time: 30 min (10 to 90 min) ����� Phase 1: Phase 2: �� Frequency: 100 Hz Frequency: ������� Pulse width:� 150 μs Pulse width: ���� ��� �� �� min �� Duration: 10 Duration: �������
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2 Hz 200 μs 20 min
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������������ Indications: Especially for lower back pain and sciatic pain syndrome ���������� �������� �� Program 5���starts with high frequency stimulation for 10 minutes, to give you ������� ������� immediate pain relief. After 10 minutes it automatically changes to a 20 �� minutes low frequency stimulation with acupuncture type impulses to release ����� endorphins and to retain the analgesic effect even beyond stimulation. � �������
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Program 6: HAN stimulation
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The device continuously changes between phase 1 and phase 2. �����
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Therapy time: 30 min (10 to 90 min) ������������ �� 1: Phase Phase 2: ������� Frequency: 100 Hz Frequency: ������������ �������� Pulse �� width:��� 150 μs Pulse width: ������� Duration: 3s Duration: �������
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�� Indications: All kinds of pain This program combines the analgesic effect of high frequency stimulation with ������� � ���� ��� ������������ endorphin release caused by ��low frequency stimulation. Every 3 seconds it �� �� ������������ �� �� changes between a “pins and needles” stimulation and a pulsing stimulation.
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This generates pulse packages (Burst). ������� �������
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Program 7: Burst
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Program 8: Modulation The frequency continuously changes within the frequency limits. The pulse width adapts accordingly. Minimal frequency: Maximal frequency: Modulation duration: Therapy time:
2 Hz (Pulse width: 200 μs) 80 Hz (Pulse width: 100 μs) 7.5 s (2 Hz 80 Hz) 30 min (10 to 90 min)
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Indications: Acute nerve or joint pain (as an alternative to P1 and P2) If you feel that the analgesic effect of program 1 or 2 is decreasing, change to ���������� program 8. With frequency modulation the body does not become accustomed to the stimulation. �
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Program 9: Muscle stimulation ��
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Frequency: Rising ramp: ����������ramp: Falling Therapy time:
50 Hz Pulse width: 2 s Working phase: 1 s Pause: 30 min (10 to 90 min)
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250 μs 5s 12 s
Indications: Prevention of muscular atrophy, muscle strengthening This program is suitable to maintain the muscle volume, e.g. during injury or recovery, or to avoid muscle atrophy. In�����case of muscle atrophy, do not stimulate more than once a day for the first month. Certainly program 9 can also be used to strengthen a healthy muscle. �
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�������� control dynamic 1 Program 10: Gate ��
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Indications: Especially for acute back pain, lower back pain, sciatic pain ���������� �� This�� program is recommended for the treatment of back pain. The massage ������������ effect provides a comfortable and pleasant stimulation. The so called Gate ������� �����this kind of stimulation is a natural Control reflex which is achieved through reflex that you achieve e.g. by rubbing a painful area with your hands to calm ����� acute pain. To achieve the massage effect it is� essential to use both channels � � � of the TENStem eco basic. ��� ���
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Frequency:�� Pulse width: Intensity modulation: Therapy time:
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TENStem eco basic
Program 11: Gate control dynamic 2 The intensity continuously changes two channels operate alternately (massage effect). See illustration program 10. Frequency: 80 Hz �������� �� ��� Pulse width: 150 μs ��������� ��������� ����� ����� s rise, 0.25 s fall Intensity modulation: 0.25 Therapy time: 30 min (10 to 90 min) ��
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Program 12 works just like program 1. However, instead of just one pulse, four ����� short pulses are generated. � � � � ��
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Program 12: Deep TENS
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Indications: Heavy legs (venous return) ����� � �� Program 11 is similar to ���program 10, but the movement of the massage waves is faster. It is used to improve the venous return for patients who suffer from heavy legs. To achieve the massage effect it is essential to use both channels ���������� �� of the TENStem eco basic. ��
Frequency: 100 Hz Pulse width: 75 μs ���������� Modulation: four pulses in a group, duration of periods 275 µs Therapy time: 30 min (10 to 90 min)
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This program could be called the last recourse if none of the other programs give analgesic effect. However, because of the high frequency this ����� program is often felt as less pleasant. Furthermore, high frequency stimulation needs more battery power. Intensity ����������
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User programs for own settings ���
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Program 13: Gate control
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Frequency: 1 - 120 Hz Pulse width: 75 - 300 μs � � � Therapy time: 10 - 90 min
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Program 14: Muscle stimulation
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Frequency: 1 - 120 Hz ����� ������� Pulse width:� 75 - 300 μs � � Intensity modulation: 1 s rise, 1 s fall � � � Therapy time: 10 - 90 min ��� �
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Frequency: 1 - 120 Hz Pulse width: 75 - 300 μs ������� Rising ramp: 2s Working phase: 5s Falling ramp: 1s Pause: 12 s Therapy time: 10 - 90 min �
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TENStem eco basic
Examples of electrode placements Back pain
Shoulder pain
Epicondylitis ulnaris
Epicondylitis radialis
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TENStem eco basic
Arthrosis (hip)
Kaada stimulation (1 channel only)
Blue Red
right handed
Sciatic pain
Gonarthrosis/knee pain
Ankle joint pain
1
2 2
1
Blue Red
left handed
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Trigeminus neuralgia
Migraine
Polyarthritis
Tension headache
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Polyneuropathy
Carpal tunnel syndrome
Pain of achilles tendon/heel pain
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TENStem eco basic
Electrode placement for dynamic stimulation (P10, P11, P15) The stimulation is not administered simultaneously on both channels. The current flowes from one electrode to the other just like a wave undulating on the body. This kind of stimulation is far more comfortable than traditional neuro-muscular stimulation. Dynamic stimulation can be used with high frequency parameters for a improved pain control or with low frequency parameters for optimized muscle stimulation. This treatment method also has an enhanced effect on lymphatic drainage stimulation. The placement of electrodes for dynamic stimulation depends on the direction of stimulation (rising/falling stimulation or sideways stimulation) Rising or falling stimulation for back or legs
Rising wave: channel 2 channel 1
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Sideways stimulation for gluteus or stomach muscle
Falling wave: channel 1 channel 2
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2
2
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Classification The TENStem eco basic is classified as being a Class IIa medical device in accordance with the law for medical devices.
Settings, modifications and repairs The manufacturer is only responsible for the safety and performance of the TENStem eco basic when settings, modifications and repairs are carried out by authorised persons, and when TENStem eco basic is used in accordance with the operating instructions.
Guarantee We guarantee the TENStem eco basic (excluding cables, electrodes, batteries) for 2 years from the date of purchase.
Maintenance and cleaning No special cleaning or care agents are required for the TENStem eco basic. Clean the unit with a soft, fluff-free cloth. Please ensure that no moisture permeates the unit. If moisture does permeate the unit, a technical check must be carried out before re-use.
Delivery content
Quantity 1 1 1 4 1
Article TENStem eco basic Cable type 7 (1 pair) Stimex self-adhesive electrodes 50 x 50 mm (4 pieces) 1.5 V battery LR03micro (AAA) Operating Manual
Art.-No. 104041 104741 281015 604000 100839
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Frequently asked questions How many times a day can I use the TENStem eco basic? We recommend to use the device 3 times a day. The pre-set therapy time of 30 minutes per program should not be extended. After a therapy session, wait for several hours before using the unit again. What intensity should I use? Do not try to increase the intensity beyond the level which is comfortable. You will either feel pins and needles or pulses depending on the program or frequency used. You will notice that the intensity often feels different even if you stimulate the same area at different times of the day. This is normal. Do not hesitate to adjust the intensity to achieve a stronger but still pleasant stimulation. The intensity of my TENS unit cannot be increased to exceed 6/8 mA. Is my TENS unit deffective? The TENStem eco basic is not deffective. Check if the cables are connected correctly to the TENS and if the electrodes are connected correctly to the cables. Try to use new electrodes. The device is equipped with a special electrodes recognition function that prevents the increase of the intensity of improperly connected electrodes to the skin and also if electrodes are warn-out. of if cables are deffective. I have been using my TENStem eco basic for 2 months and I feel that the stimulation is less effective. This could be due to the following reasons: - The electrodes need to be changed. - Your body has adapted to the repeated stimulation. We recommend to change the program or the placement of the electrodes. Can electrodes adhere to hairy skin? In case of strong hair growth we recommend to shave the skin before placing the electrodes, but usually this is not necessary.
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Accessories The following accessories can be combined with the TENStem eco basic. Stimex self-adhesive electrodes Art. No. 281000 282000 283400 281032 283600 281007 283000 283100 281027
Article Stimex 32 mm round Stimex 50 mm round Stimex 50x50 mm Stimex 50x50 mm Stimex 50x90 mm Stimex 50x90 mm Stimex 50x130 mm Stimex 80x130 mm Stimex sensitive 50x50 mm
Pieces 4 4 4 20 2 4 2 2 4
Flower Power self-adhesive electrodes Art. No. 281042 281035 281040
Article Flower Power 50 mm round Flower Power 50x50 mm Flower Power 50x90 mm
Pieces 4 4 4
Silicone electrodes (to be used with contact gel) Art. No. 107090 107060 107075 107035 107020 107055 107011 107010 107050 107070 108000
Article Silicone electrode 20 mm round Silicone electrode 25 mm round Silicone electrode 40x28 mm Silicone electrode 56x28 mm Silicone electrode 75x30 mm Silicone electrode 90x35 mm Silicone electrode 38x45 mm Silicone electrode 48x48 mm Silicone electrode 70x65 mm Silicone electrode 70x140 mm Contact gel for silicone electrodes (60 g)
Pieces 2 2 2 2 2 2 2 2 2 2 1
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MedicoBack: for the treatment of low back pain Low back support bandage with pelotte and integrated electrodes to be used with pain management programs of the TENStem eco basic. MedicoBack P-type offers patients lumbar vertebrae stabilization and support as well as easy stimulation provided by the integrated electrodes. The pelotte with its massage nubs enhances the pain relieving effect. MedicoBack P-type may be used for slight or acute pain as well as for chronic pain in the lower back area. Art. No. 107034 107036 107037 107038 107039
Article MedicoBack P-type MedicoBack P-type MedicoBack P-type MedicoBack P-type MedicoBack P-type
Size S M L XL XXL
Length 85 cm 93 cm 102 cm 104 cm 121 cm
Stimex garment electrodes: gloves and socks The gloves and socks used in combination with the TENStem eco basic provide stimulation of the entire hand and/or foot and ankle and avoid the sometimes tiresome attachment of self-adhesive electrodes on the hand or the foot. Gloves Art. No. 107014 107021 107022
Article Stimulation gloves Stimulation gloves Stimulation gloves
Size S M L
Pair 1 1 1
Article Stimulation socks Stimulation socks
Size M L
Pair 1 1
Socks Art. No. 107023 107024
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Running program Parameters of the program
Treatment time
Intensity level
ON/OFF, Stop Program choice
Increase intensity
Increase intensity
Decrease intensity
Decrease intensity
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Program No.
Program name
Indication
1
Gate control 1
Nociceptive pain, acute pain, neuropatic pain
2
Gate control 2
Alternative to program 1
3
Low frequency
Chronic nociceptive pain, improvement of blood circulation, Kaada stimulation
4
Gate control + low frequency
Combination of high and low frequency stimulation
5
Adaptation
Muscular pain
6
HAN
Suitable for almost all kinds of pain program
7
Burst
Alternative to program 3 (more comfortable)
8
Modulation
Alternative to the other programs in case of therapy resistance
9
Muscle stimulation
Atrophy prophylaxis, muscle strengthening
10
Gate control dynamic 1
Muscle relaxation
11
Gate control dynamic 2
Muscle relaxation, venous return
12
Deep TENS
Muscular pain, deep seatted pain
13
TENS stimulation
Pain treatment (see programs 1-3)
14
Muscle stimulation
Muscular pain, deep seatted pain
15
Gate control dynamic
Muscle relaxation
User programs
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Description
Frequency/Hz
Pulse width/µs
Time/min
Both channels
100
200
30
Both channels
80
150
30
Both channels
2
250
30
Channel 1: 100 Hz Channel 2: 2 Hz
Channel 1: 100 Channel 2: 2
200
30
First 10 min 100 Hz, then 20 min with 2 Hz
100/2
150/200
10/20
3 s 100 Hz, then 3 s 2 Hz etc.
100/2
150/200
30
100 Hz for 0.25 s
100
150
30
Automatic frequency run from 2 Hz to 80 Hz within 7.5 s
2 - 80
200 - 100
30
Increase 2 s, working time 5 s, decrease 1 s, pause 12 s, automatic intensity adaption
50
250
30
Intensity within 1 s to maximum, then within 1 s reduced to 50%. Both channels in alternating operation
80
150
30
Intensity within 0.25 s to maximum, then within 0.25 s reduced to 50%. Both channels in alternating operation
80
150
30
Impuls packages of 4 impulses. 200 µs between each impuls
100
75
30
Both channels
1-120
75-300
10-90
Increase 2 s, working time 5 s, decrease 1 s, pause 12 s (automatic intensity adaptation)
1-120
75-300
10-90
Intensity within 1 s to maximum, then within 1 s reduced to 50%. Both channels in alternating operation
1-120
75-300
10-90
schwa-medico · Export Department Wetzlarer Strasse 41-43 · 35630 Ehringshausen · Germany Tel. +49 6443 8333-113 · Fax +49 6443 8333-119 E-Mail [email protected] · www.schwa-medico.com Manufacturer: Pierenkemper GmbH Hoernsheimer Eck 19 · 35578 Wetzlar · Germany www.pierenkemper.eu Art.-Nr. 451600-0265