WL-2302 - IBP - Free user manual and instructions

USER MANUAL WL-2302 IBP

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How do these instructions for use support you? ... 29

How your Kalm Patch works 30

Your safety is important to us 31

For which use is your Kalm Patch suited, and for which is it not? 31

For which applications is your Kalm Patch suited, and for which is it not? 32

When may you not use your Kalm Patch? 32

Other factors you need to consider 33

How to protect your Kalm Patch 33

How to prepare your Kalm Patch for use 34

Unpacking and checking the Kalm Patch 34

Inserting the battery 36

How to conduct a session 38

On which stimulation points may you apply your Kalm Patch? 39

How long and how often may you use your Kalm Patch? 40

How to use your Kalm Patch 40

Special applications 43

Stiff Neck and Headaches 43

Back Pain and Lumbago 43

Calf Muscle Cramps and Poor Circulation 44

How to clean and care for your Kalm Patch 45

Changing the patch 46

Changing the battery 46

In case problems occur 47

Service and Warranty 49

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.

11.1 Service Address 49 11.2 Warranty and Compensation for Damages 50 12. 13.

Disposal and Environmental Protection 50 What does the designation on your product mean? 51

2. How your Kalm Patch works

3. Your safety is important to us

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

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.

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.

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.

The Kalm Patch does not supply your body with active chemical ingredients. Consequently you will not suffer the side effects experienced with analgesics. 30

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 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.

4. 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.

► if you suffer from allergic skin reactions. The electrodes and patch can lead to skin irritations.

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. 2. Check if the scope of delivery is complete: Kalm Patch with inserted electrode patch and protective foil Battery Protective cover Instructions for use 3. 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).

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Kalm Patch Elektronisches Pflaster zur Schmerzlinderung Electronic Pain Relief Patch Pansement électronique antidouleur Elektronische pleister voor pijnverlichting Parche electrónico calmante

5.2 Insert battery If the battery has not yet been inserted: 1. Unwrap battery.

If the battery has already been inserted: 1. Open battery compartment: Push down the cover using your thumb and slide back.

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

2. Remove battery. 3. Remove safety strip. 3. Insert battery. The “+” symbol on the battery must face up.

4. Close battery compartment.

4. Reinsert battery. The “+” symbol on the battery must face up!

5. 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 10 cm to 15 cm 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?

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

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 1 m 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.

ON+ button Illuminated display OFF– button 4. 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.

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. 5. 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. 6. Remove the Kalm Patch from the skin: Slide a finger underneath the electrode patch and lift up the electrode patch. 7. 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. 8. Terminate the application: ● Apply the protective foil to the electrode patch. ● Place the Kalm Patch inside the protective cover. ● 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.

3. 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.

8. 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

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.

► 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.

Replace the patch. The patch is dried out.

8.3 Changing the battery

The patch does not adhere any longer.

The Kalm Patch is defective.

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

Replace the battery.

Mail your Kalm Patch to our service department, see Service and Warranty.

The battery is empty.

2. Remove the electrode patch from the Kalm Patch.

Replace the battery.

The battery is not inserted.

The Kalm Patch is switched on, but does not function.

1. Turn off the Kalm Patch.

The stimulation is too weak.

Possible Cause Problem

Replace the electrode patch when it is dirty or worn.

Dispose of the Kalm Patch, see Disposal and Environmental Protection

9. In case problems occur

8.2 Changing the patch

11. Service and Warranty

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)

11.1 Service Addresses

Classification according to 93/42/EWG: Class IIa Model Description: WL-2302 Maximum permissible ambient temperature: 10°C - 45°C 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: 50 mA Pulse width:

Operating voltage: 3 V Weight:

Dimensions (mm): W:55 x D:10 x H:60 48

England: International Business Products Limited 6 Newfield Court West Houghton Bolton BL5 3 SA England Phone: +44(0) 19 42 – 8196 95 India: sano health care products pvt. Ltd.-Group Corporate Office: 28 Landsdown Terrace 1st Floor Kolkata – 700 026 Phone: +91 33 2465 0383-85

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. 49

12. Disposal and Environmental Protection

13. What does the designation on your product mean?

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.

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

Battery safety instructions: ► Do not short-circuit battery ► Do not throw battery into fire Explosion Hazard Your retailer will answer additional questions regarding disposal

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

The product meets the safety requirements of EU guideline 93/42/EWG 50

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De Kalm Patch is defect

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