KALM PATCH - Electronic dressing IBP - Free user manual and instructions

USER MANUAL KALM PATCH IBP

Instructions for Use 28

Mode d'emploi 52

Well-Life Healthcare Limited
1Fl., No. 16Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Geratotyp:

Gerät zur transkutanen elektrischen Nervenstimulation (TENS)

10.1 Service Adresse

ibp Service Center

Am Weimarer Berg 6

D-99510 Apolda

Germany

Tel.: [phone]

1. How do these instructions for use support you?...29
2. How your Kalm Patch works 30
3. Your safety is important to us 31
   3.1 For which use is your Kalm Patch suited, and for which is it not? 31
   3.2 For which applications is your Kalm Patch suited, and for which is it not? 32
   3.3 When may you not use your Kalm Patch? 32
   3.4 Other factors you need to consider 33
4. How to protect your Kalm Patch 33
5. How to prepare your Kalm Patch for use 34
   5.1 Unpacking and checking the Kalm Patch 34
   5.2 Inserting the battery 36
6. How to conduct a session 38
   6.1 On which stimulation points may you apply your Kalm Patch? 39
   6.2 How long and how often may you use your Kalm Patch? 40
   6.3 How to use your Kalm Patch 40
7. Special applications 43
   7.1 Stiff Neck and Headaches 43
   7.2 Back Pain and Lumbago 43
   7.3 Calf Muscle Cramps and Poor Circulation 44
8. How to clean and care for your Kalm Patch 45
   8.1 Cleaning 45
   8.2 Changing the patch 46
   8.3 Changing the battery 46
9. In case problems occur 47
10. Technical Data 48
11. Service and Warranty 49
    11.1 Service Address 49
    11.2 Warranty and Compensation for Damages 50
12. Disposal and Environmental Protection 50
    13.What does the designation on your product mean? 51

1. How do these instructions for use support you?

Warning! This symbol warns you of possible health risks.

Caution! This symbol alerts you of possible damage to your device.

Note This symbol indicates particularly useful information regarding the use of the device.

Important components of your device have been marked with item numbers.

Using these item numbers you can safely identify displays and controls, the importance and use of which will be explained in these instructions.

Therefore you will find the item numbers placed in brackets in all corresponding paragraphs of these instructions for use.

2. How your Kalm Patch works

Kalm Patch is an electronic patch, which alleviates pain and improves the mobility of affected parts of the body.

Pain is always an expression of a medical problem. First clarify the cause of the pain with your physician and then try to use the Kalm Patch for pain relief.

Kalm Patch combines the effects of electronic muscle stimulation (EMS) and transcutaneous - conducted via the skin - electrical nerve stimulation (TENS): A microprocessor-controlled stimulation program conducts current-induced stimuli of different intensity levels via electrodes that are affixed onto the skin to the affected regions, stimulates the muscles and blocks the conduction of the painful stimulus to the brain. These stimuli from the stimulation program are not painful. You will only feel a slight tingling sensation and slight muscle contractions.

Typical Applications:

Pain from a wound: contusions, edema, sprains
Back pain: stiffness, contractures, lumbago
Tendon-Muscle pain: muscle spasm, tendonitis, tennis elbow, contractures, blockages
Neurological pain: neuralgia, pain after shingles

During the first few days you will typically start with an application lasting 30 minutes, which may be extended to 2 hours per day if needed.

The Kalm Patch does not supply your body with active chemical ingredients. Consequently you will not suffer the side effects experienced with analgesics.

3. Your safety is important to us

Please read these instructions for use carefully before using your Kalm Patch for the first time. They contain everything you need to know to operate your Kalm Patch safely and to avoid damage.

These instructions for use are part of your device. Store these instructions for use carefully until you either pass your Kalm Patch on to a new owner along with these instructions or until you dispose of your Kalm Patch.

3.1 For which use is your Kalm Patch suited, and for which is it not?

Use the Kalm Patch exclusively in a private setting.
The Kalm Patch is not intended for commercial or medical use.
The Kalm Patch is intended exclusively in humans for external application on the stimulation points described in these instructions of use.
The Kalm Patch is not intended for application on children - not even under the permanent supervision of adults.

3.2 For which applications is your Kalm Patch suited, and for which is it not?

The Kalm Patch is intended exclusively for alleviating pain.
Pain can also be symptomatic of a serious illness, which excludes self-treatment with the Kalm Patch.

Prior to its use, we recommend that you consult your physician, pharmacist or physiotherapist.

3.3 When may you not use your Kalm Patch?

Do not use the Kalm Patch

• if you suffer from cardiac problems, especially from cardiac dysrhythmias. The stimulation current can lead to ventricular fibrillation and in the worst case to cardiac arrest.
• if you have a pacemaker or other electronic implants. The stimulation current can interfere with the function of your implant.
  if you suffer from seizures. In severe cases the stimulation current can trigger convulsions.
  when pregnant. In severe cases the stimulation current can trigger contractions.
  if you suffer from allergic skin reactions. The electrodes and patch can lead to skin irritations.

if you suffer from systemic illnesses, i.e. those affecting the entire body.
if the Kalm Patch is damaged. The stimulation current can lead to aches and skin irritations.

3.4 Other factors you need to consider

Do not allow children access to your Kalm Patch.

Children could swallow small pieces and as a consequence suffocate.

1. How to protect your Kalm Patch

The electronics of your Kalm Patch tolerate neither wetness nor moisture.

Do not rinse the Kalm Patch under running water, do not immerse it in water or other fluids, and do not wear it while swimming or while in the sauna.

• Your Kalm Patch is sensitive to heat.

Do not expose the Kalm Patch to direct sunlight, and do not place it on hot surfaces.

5. How to prepare your Kalm Patch for use

5.1 Unpacking and checking the Kalm Patch

1. Unpack your Kalm Patch.

Please save the original packaging so that you may send your Kalm Patch safely to our service department in case of repairs.

1. Check if the scope of delivery is complete:

① Kalm Patch with inserted electrode patch and protective foil
② Battery
③ Protective cover
(4) Instructions for use

1. Check your Kalm Patch for possible damage from transport.

If your Kalm Patch should be damaged, please contact our service department (see Service and Warranty).

5.2 Insert battery

If the battery has not yet been inserted:

1. Unwrap battery.
2. Open battery compartment: Push down the cover using your thumb and slide back.

1. Insert battery.

The "+" symbol on the battery must face up.

1. Close battery compartment.

If the battery has already been inserted:

1. Open battery compartment: Push down the cover using your thumb and slide back.

1. Remove battery.
2. Remove safety strip.
3. Reinsert battery.

The "+" symbol on the battery must face up!

1. Close battery compartment.

6. How to conduct a session

Apply the Kalm Patch only on such stimulation points of the skin that are described in this section. Do not use the device

on the eyelids. The stimulation current can damage the eye.
in the laryngeal or pharyngeal areas. The stimulation current can lead to muscle cramping and possibly to suffocation.
such that the current flows directly across the heart (e.g. in direct vicinity of the heart). The stimulation current can lead to ventricular fibrillation and in severe cases to cardiac arrest.
such that the current flows directly across the brain (e.g. on the temples). The stimulation current can trigger convulsions.
on a wound or a tumor

If fatigue or skin irritation occurs,abort the use of the Kalm Patch. Should the state of fatigue continue, consult a physician.

If the pain does not decrease, or even increases after application of the Kalm Patch for 2 to 3 days, consult a physician.

6.1 On which stimulation points may you apply your Kalm Patch?

You may apply your Kalm Patch directly onto the painful area - with the exception of your head, rib cage or a defective skin area (wound). The Kalm Patch is effective in an area of about 10cm to 15cm around the device and in the lower-lying muscles.

Always treat only one area per day. In case of pain across a large surface or pain in several areas, you can treat a different area the following day.

Examples:

Arthritis attack in the thumb attachment region
Tennis elbow
Tendonitis in the knee
Sprained ankle

Special Circumstances:

Frequent symptoms such as

■ stiff neck and headaches
back pain and lumbago
- calf cramp and poor circulation

require special application of your Kalm Patch: See Section 7 „Special Uses".

6.2 How long and how often may you use your Kalm Patch?

Do not exceed the listed application duration and frequency. It will not increase its effectiveness.

During the first 2 to 3 days start with an application of no more than 30 minutes a day. Thereafter, you may gradually increase the application duration to a total of 2 hours a day.

In case of chronic pain, the application should not exceed 30 minutes per day. Conduct the application at intervals of 2 or 3 days.

6.3 How to use your Kalm Patch

During your applications, maintain a minimum distance of 1m to microwave devices and short-wave devices. Electromagnetic interaction may impair the function of the Kalm Patch.

1. Remove the protective foil from the electrode patch.
2. Apply to Kalm Patch to one of the stimulation points.

Apply the Kalm Patch only to clean, dry, healthy skin that has not been treated with cosmetics and creams.

The Kalm Patch must adhere firmly to the skin. Replace the electrode patch when its adhesiveness has subsided.

1. Turn on the Kalm Patch: Push the ON+ button once. The illuminated display blinks red.

① ON+ button
② Illuminated display
③ OFF- button

1. Adjust the stimulation intensity as high as possible: The stimulation should not create an unpleasant feeling or pain!

The intensity of the stimulation is increased with the ON+ button and decreased with the OFF- button. You may set the intensity of the stimulation to 10 different levels.

• Repeatedly press the ON+ button until you have reached the highest stimulation intensity that feels comfortable to you. The brightness of the illuminated display increases with the amount of stimulation intensity.
• Repeatedly press the OFF- button if you would like to lower the stimulation intensity. The brightness of the illuminated display decreases with the decreasing stimulation intensity.

i Your Kalm Patch automatically turns off after 15 minutes. Turn the Kalm Patch back on if you wish to continue the application.

Lower the stimulation intensity or turn off the Kalm Patch if the effect should become unpleasant.

1. Turn off the Kalm Patch after an application duration of 30 minutes: Press the OFF- button repeatedly until the illuminated display turns off.

Remove the electrode patch from the skin only in off-mode.

1. Remove the Kalm Patch from the skin:

Slide a finger underneath the electrode patch and lift up the electrode patch.

1. Moisten the back of the electrode patch with a drop of water each on the left and right sides to protect the electrode patch from drying out.

2. Terminate the application:

3. Apply the protective foil to the electrode patch.

4. Place the Kalm Patch inside the protective cover.
5. Store the Kalm Patch out of the reach of children and protected from sunlight and moisture until the next application.

7. Special applications

Prior to starting the application, read Section 6 "How to conduct a session".

7.1 Stiff Neck and Headaches

1. Place the Kalm Patch on the neck. If you have two Kalm Patches available, you may apply them simultaneously on the left and the right.

2. Select a high output at level 4 or 5: The neck muscles will react to the stimulation by contracting and relaxing. The application on either side should not exceed 30 minutes.

3. Apply the Kalm Patch to the other side and repeat the application.

Do not exceed an overall daily application duration of 60 minutes.
7.2 Back Pain and Lumbago
In the following cases sufficient pain relief is not to be expected:

in obese persons
in the case of severe sciatica

Apply the Kalm Patch next to the spinal column on the painful area. If you have two Kalm Patches available, you can apply these simultaneously on the left and the right.

Select a very high output at levels 6 to 7: The muscles react to the stimulation by contracting and relaxing.

Repeat the application as needed on a different stimulation point.

Do not exceed an overall daily application duration of 2 hours.

Stimulation points:

center of your back
lumbar region
lower back

7.3 Calf Muscle Cramps and Poor Circulation

Applying your Kalm Patch can improve the function of your leg muscles in order to avoid or prevent fatigue and pain. Its application can enhance circulation in the legs and aids in preventing frequent calf muscle cramps. Its application is especially helpful when sitting for extended periods, e.g. during travel.

1. Apply the Kalm Patch on the center of the shinbone or the center of the calf.
2. Select an average output at level 3 or 4: The muscles will react to the stimulation by contracting and relaxing.

1. Repeat the application on the other leg.

Apply your Kalm Patch no more than 1 hour per leg. Do not exceed an overall daily application duration of 2 hours.

1. How to clean and care for your Kalm Patch

8.1 Cleaning

1. Turn off the Kalm Patch.
2. Clean the housing with a damp cloth.

Do not clean the housing with caustic or abrasive cleansers.
Do not sterilize the electrode patch or the device itself in a steam sterilizer or in a cold sterilizing bath

8.2 Changing the patch

Replace the electrode patch when it is dirty or worn.

1. Turn off the Kalm Patch.
2. Remove the electrode patch from the Kalm Patch.

1. Place the new electrode patch on the Kalm Patch.

8.3 Changing the battery

Danger of poisoning and suffocation!

Children could swallow batteries. Keep batteries out of reach of children.

Do not throw batteries into fire.

Only insert into the Kalm Patch batteries in compliance with the specifications listed in the "Technical Data" section

Do not attempt to recharge the batteries!

Change the battery as described in the "Inserting the battery" section.

9. In case problems occur

Problem	Possible Cause	Solution
The Kalm Patch is switched on, but does not function.	The battery is not inserted.	Insert the battery.
	The battery is empty.	Replace the battery.
	The Kalm Patch is defective.	Mail your Kalm Patch to our service department, see Service and Warranty.
		or
		Disposé of the Kalm Patch, see Disposal and Environmental Protection
The stimulation is too weak.	The battery is low.	Replace the battery.
The patch does not adhere any longer.	The patch is dried out.	Replace the patch.

10. Technical Data

Manufacturer:

Well-Life Healthcare Limited
1Fl., No. 16Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Type of device:

Device for transcutaneous electrical nerve stimulation (TENS)

Classification according to 93/42/EWG:

Class Ila

Model Description:

WL-2302

Maximum permissible ambient temperature:

10^ - 45^

Maximum permissible relative humidity:

30% - 75%

Maximum permissible air pressure:

700 hPa - 1060 hPa

Battery:

Coin cell type CR2032, 3 V, non-rechargeable

Max. output of electrodes: 50mA

Pulse width: 115 - 250 μs

Pulse rate: 2 - 30 Hz

Operating voltage: 3V

Weight: 10 g (w/o Battery)

Dimensions (mm): W:55 x D:10 x H:60

11. Service and Warranty

11.1 Service Addresses

England:

International Business Products Limited
6 Newfield Court
West Houghton

Bolton BL5 3 SA England

Phone: [phone] - 8196 95

India:

sano health care products pvt. Ltd.-Group

Corporate Office:

28 Landsdown Terrace

1st Floor

Kolkata - 700 026

Phone: [phone]

11.2 Warranty and Compensation for

Damages

Starting with the purchase date (date on proof of purchase or receipt) we will perform repairs free of charge for 24 months, should your device be non-operational due to manufacturing or material defects.

The warranty excludes damage resulting from non-compliance or only partial compliance with these instructions for use.

Farther-reaching claims such as compensation for damages are likewise excluded.

Please send your device in question as well as the proof of purchase or receipt and the description of the complaint to our service address.

Please also attach the warranty documents if you would like to file a warranty claim.

Batteries and electrodes are excluded from the warranty.

12. Disposal and Environmental Protection

12.1 Battery disposal / battery safety instructions

Do not dispose of used batteries in domestic waste, but instead in hazardous waste or take them to a battery collection site available at your retailer.

Battery safety instructions:

Do not short-circuit battery
Do not throw battery into fire Explosion Hazard

Your retailer will answer additional questions regarding disposal

13. What does the designation on your product mean?

The name plate is located on the bottom of the Kalm Patch.

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

serial number

At the end of its life cycle, this product must not be disposed of in regular domestic waste, but must be taken to a collection site for recycling electric and electronic devices (disposal of used appliances).

Type BF application device The application device offers protection against electrical shock by standard compliance to leakage currents (Type B). The application device is insulated (Type F).

Follow instructions for use

C E

The product meets the safety requirements of EU guideline 93/42/EWG

Well-Life Healthcare Limited
1Fl., No. 16 Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Type d'appareil :

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

Numero de série

Well-Life Healthcare Limited
1Fl., No. 16 Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Apparaattype:

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

Serienummer

Well-Life Healthcare Limited
1Fl., No. 16 Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, Républca de China

Tipodequipment:

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