Kegel Toner - Pain therapy device TensCare - Free user manual and instructions

USER MANUAL Kegel Toner TensCare

Simple line drawing of a flag and a stylized object with a dark oval shape inside, no text or symbols present.

Clean the probe with an alcohol-free anti-bacterial wipe or with warm soapy water

Illustration of a human leg and a blood glucose meter device (no text or symbols present)

Connect the unit with the vaginal probe and insert the probe

ON 20 TRAIN 3

Press and hold the ON button to switch the device on

20 ONE 0 Button P 4

Select the programme by pressing the button P

5 E ONE 25 UP DOWN

Regulate the output intensity with the buttons ▲ and ▼

OFF 6

Press and hold the OFF button to switch the device off

For the full version instructions for use, visit: www.tenscare.co.uk/continence/kegel-toner

CONTENTS

1. INTRODUCTION....4
2. INDICATIONS FOR USE 4
3. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS 5
4. PROGRAMMEMES......9

4.1. PROGRAMMEME SETTINGS 9
4.2. PRESET PROGRAMMES....9

1. CONTENT 10
2. UNIT INFORMATION......11

6.1. CONTROLS & DISPLAY 11
6.2. OPERATING INSTRUCTIONS ..... 11

1. SETTING UP AND USING THE KEGEL TONER .....15

7.1. INSTALLATION OF BATTERIES 15
7.2. CONNECTING LEAD WIRE....16
7.3. PREPARING FOR SESSION....16
7.4. TRAINING SESSION....16
7.5. AFTER YOUR TRAINING SESSION ...... 18

1. CLEANING 19
2. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS ....19
3. ACCESSORIES 19
4. TROUBLESHOOTING 20
5. GENERAL SPECIFICATION 23
6. EMC....24

SYMBOLS USED

	TYPE BF APPLIED PART: Equipment providing a degree of protection against electric shock, with isolated applied part. Indicates that this device has conductive contact with the end user.
	This symbol on the unit means “Refer to instructions for use”.
	Temperature Limitation: indicates the temperature limits to which the medical device can be safely exposed.
	Lot Number: indicates the manufacturer's batch code so that the batch or lot can be identified.
	Humidity Limitation: indicates the humidity limits to which the medical device can be safely exposed.
	Serial Number: indicates the manufacturer's serial number so that a specific medical device can be identified.
	Do not dispose in household waste.
	Catalogue Number: indicates the manufacturer's catalogue number so that the device can be identified.
	Atmospheric Pressure: indicates the atmospheric limits to which the medical device can be safely exposed.
	Manufacturer Symbol
	Date of Manufacture: indicates the date which the medical device was manufactured. This is included within the serial number found on the device (usually on the back of the device), either as “E/Year/Number” (YY/123456) or “E/Month/Year/Number” (MM/YY/123456).
	Medical Device
	This medical device is indicated for home use.
	CE Mark
	Importer Symbol

IP22

This medical device is not water resistant and should be protected from liquids.

The first number 2: Protected against access to hazardous parts with a finger, and the jointed test finger of 12 mm ø, 80 mm length, shall have adequate clearance from hazardous parts, and protected against solid foreign objects of 12.5 mm ø and greater.

The second number 2: Protected against vertically falling water drops when enclosure is tilted up to 15^ . Vertically falling drops shall have no harmful effects when the enclosure is tilted at any angle up to 15^ on either side of the vertical.

1. INTRODUCTION

Device Description & Principles of Design

The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles.

The Kegel Toner is very easy to use, with two preset training programmes, two choices of exercise time and simple push button control.

2. INDICATIONS FOR USE

The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.

The Kegel Toner is intended for adult women suffering from the involuntary loss of urine when coughing, laughing, sneezing or exercising (known as stress urinary incontinence).

If you leak urine when you cough, sneeze, laugh, strain or make sudden movements, this is called Stress Incontinence.

It is particularly common in women who have had a natural childbirth and occurs when the bladder neck and the other mechanisms that act to hold urine in the bladder are not working properly. The most common cause is a weak pelvic floor.

Kegel Toner is not recommended if you ONLY have symptoms of urinary frequency or urgency (using the restroom very frequently or having to rush to the restroom) and have NO symptoms of leakage when coughing, laughing, sneezing or exercising.

Warning: Not suitable for use in children without medical supervision.

3. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS

In this manual:

A Contraindication is used when a device should not be used because the risk of use clearly outweighs any foreseeable benefits and may result in serious injury or death.

A Warning is used when failure to follow the instructions may result in serious injury or death.

A Caution is used when failure to follow the instructions may result in a minor or moderate injury, or damage to the device or other property.

Notes are used to provide clarification or recommendation.

CONTRAINDICATIONS:

• Do not use if you are pregnant
• Do not use if you are attempting to become pregnant
• Do not use if you have a cardiac demand pacemaker or implanted defibrillator
• Do not use if you have symptoms of active urinary tract infection, vaginal infections, or localized lesions
• Do not use if you have a diagnosis of extra-urethral or overflow incontinence
• Do not use if you have severe urine retention
• Do not use if you have poor sensation in the pelvic region
• Do not use if you have cognitive disabilities, i.e.; Alzheimer's disease or dementia

• Do not use if you are unable to properly insert the Trainer

• Do not use if you have active pelvic cancer

• Do not use if you have an intestinal clamp
• You must be 6 weeks post pelvic surgery or vaginal childbirth to use this device
• Do not use this device for diagnostic purposes or critical patient monitoring
• This device is not (external) defibrillator-proof

WARNINGS:

Warning: The Kegel Trainer is intended for single patient use only. Do not share your Kegel Trainer with anyone else. Improper treatment or cross-infection may occur.

Warning: The device should not be used while walking, driving, operating machinery, or any other activity in which involuntary muscle contraction may put you at risk of injury.

Warning: If you have active cancer, consult with your clinician before use due to concerns for stimulation potentially spreading cancerous cells.

Warning: Caution should be used if you have suspected or diagnosed heart problems because stimulation devices can affect heart rhythm in certain circumstances.

Warning: Caution should be used if you have suspected or diagnosed epilepsy as unexpected seizures may impair usage.

Warning: Caution should be used if you have a bleeding disorder as stimulation increases blood flow to the stimulated region.

Warning: Do NOT use Kegel Toner while simultaneously connected to high frequency surgical equipment as it may result in burns at the site of stimulator electrodes and possible damage to the stimulator

CAUTIONS:

Caution: Read all instructions before use. Failure to follow these directions may result in personal injury or damage to the equipment.

Caution: Do not use a Kegel Toner device that appears to be damaged. Using a damaged device may result in personal injury.

Caution: If tissue irritation occurs, discontinue treatment immediately. Ask your care provider for advice before continuing further treatment to prevent injury.

Caution: Kegel Toner is intended for indoor use only because it is an electronic device.

Caution: Only use recommended cleaning solutions that leave no residue to prevent irritation or infection. Do not soak as this could damage the device.

Caution: It is important that the Trainer is cleaned after each use. Ineffective cleaning may lead to irritation or infection.

Caution: Never insert or remove Kegel Trainer unless the control unit is powered OFF as insertion or removal when stimulation is active may cause discomfort or tissue irritation.

Caution: Do not use a silicone-based lubricant on the stimulation contacts as it may decrease the effectiveness of Kegel Toner's muscle stimulation.

Caution: Caution should be used if you have total/partial prolapse of the uterus/vagina.

Caution: The long-term effects of chronic muscle stimulation are unknown.

Caution: Skin irritation and burns beneath stimulation contacts have been reported with the use of powered stimulators.

Caution: Do not use the device in water because it is an electronic device and use in water may cause patient injury.

Caution: Do not operate device within 10 feet of operating televisions, arc welders, radio thermal treatment equipment, X-ray machines, MRI machines, or any other equipment that produces magnetic fields, sparks, or radio transmissions, RF communication equipment can affect this device.

Caution: The stainless steel in the Trainer electrodes contains some Nickel. This could cause a reaction if you have a Nickel allergy.

Caution: The Kegel Trainer is intended for single patient use only. Do not share your Kegel Trainer with anyone else.

Improper treatment or cross-infection may occur.

Caution: It is important that the Kegel Trainer is cleaned after each use. Ineffective cleaning may lead to irritation or infection.

Caution: Never insert or remove Kegel Trainer unless the control unit is powered OFF as insertion or removal when stimulation is active may cause discomfort or tissue irritation.

Caution: If tissue irritation occurs, discontinue treatment immediately. Ask your healthcare professional for advice before continuing further treatment to prevent injury.

Caution: Do not use a silicone-based lubricant on the metal plates of the Kegel Trainer as it may decrease the effectiveness of Kegel Toner's muscle stimulation.

Caution: The stainless steel in the Kegel Trainer's metal plates contain some Nickel. This could cause a reaction if you have a Nickel allergy.

Caution: Do not use this device with Kegel Trainer other than those recommended by the manufacturer in section 10. Electrodes with smaller surface area may cause tissue irritation.

TO KEEP YOUR DEVICE IN GOOD WORKING ORDER, OBSERVE THE FOLLOWING ADDITIONAL CAUTIONS:

Caution Not intended for use in an oxygen rich environment.

Caution Not intended for use in conjunction with flammable anaesthetics or flammable agents.

Caution The patient is an intended operator.

Caution Do not service and maintain the device while in use.

Caution Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.

If necessary, we will provide circuit diagrams, component part lists or other information that will assist authorized service personnel to repair the device.

Caution The operator should not touch the patient at the same time when touching the battery output.

Caution: There are no user serviceable parts. No modification of this equipment is allowed.

Caution Keep away from pets and pests

Caution: should be observed when using the Kegel Toner at high strength settings. Kegel Toner has a Yellow LED light on

output socket which means the output will exceed 10 mA (R.M.S) or 10 V (R.M.S) averaged over any period of 1 sec. Prolonged use at high settings may cause muscle injury or tissue inflammation.

Do not use this device with a leadwire or Trainer other than those recommended by the manufacturer in section 10.

Do not immerse your unit or Trainer in water or place it close to excessive heat as this may cause it to cease to operate correctly.

Do not attempt to open up the unit. This may affect the correct operation of the unit and will invalidate the guarantee.

Do not mix old, new or different types of batteries as this may lead to battery leakage or low battery indication.

Caution: Temperature & Relative Humidity of storage: -25°C to +70°C, up to 93% R.H. Temperature & Relative Humidity of transportation: -25°C to +70°C, up to 93% R.H.

4. PROGRAMMEMES

4.1. PROGRAMMEME SETTINGS

Programme	TRAIN	TONE
Freq. (Hz)	50	35
Pulse width (μs)	300	250
Ramp Up & Down (s)	1	2
Plateau (s)	5	3
Rest (s)	10	6
Default duration (min)	20	20

4.2. PRESET PROGRAMMES

The Kegel Toner has two preset programmes. One to treat stress incontinence (TRAIN) and one aftercare programme to tone the pelvic floor muscles (TONE).

STRESS INCONTINENCE:

Shown on the screen as: TRAIN

The TRAIN programme strengthens the muscles of the pelvic floor using gentle stimulation. Once these muscles are stronger they are better able to resist urinary leakage caused by external pressure being applied to the bladder such as with a cough, sneeze or physical exertion.

The stimulation causes the muscles to contract and work. This builds their strength.

Like any exercise this takes time to show results. Successful treatment requires use once a day for one to three months. You may notice an improvement after about four weeks. It helps to keep a diary of leakage problems so that you can measure this improvement.

AFTERCARE:

Shown on the screen as: TONE

Having restored your pelvic floor muscles to an excellent condition you will want to keep them toned and strong. Regular use of this programme, about twice a week, will ensure that your muscles remains fit and toned.

The TONE programme may also be used as an alternative treatment for TRAIN.

5. CONTENT

The pack contains:

• 1 x Kegel Toner continence stimulator unit
• 1 x Lead wire (L-CPT)
  • 1 x Liberty Kegel Trainer (X-VPK)
• 2 x AA 1.5V alkaline batteries
• 1 x Storage pouch

6. UNIT INFORMATION

6.1. CONTROLS & DISPLAY

Keypad Lock Low Battery ON button OFF button Time selector Output active indicator 20 min TRAIN mA Program duration (min) Program selected Strength selected (mA) Program selector Strength up Strength down Kegel Toner

6.2. OPERATING INSTRUCTIONS

ON/OFF

To turn the unit on, press the ON button and hold for 3 to 5 seconds until the display shows.

To turn the unit off, press ▼ button to remove keypad lock and press the OFF button and hold for 3 to 5

seconds until the display stops.

At first use, or after changing batteries, the display shows that the unit is automatically set in programme TRAIN at zero strength.

When switched on the unit will automatically start in the programme which was being used when it was last switched off.

When switched on the unit will automatically start in the programme which was being used when it was last switched off.

During start up to stop the increase in strength at any time, press any key once.

The unit will turn off automatically:

• When the Timer reaches zero,
• If it is left at zero strength for more than 5 minutes.

Note: Always check unit is OFF before applying or removing Kegel Trainer.

The backlight will turn off 10 seconds after the last button press.

STRENGTH CONTROLS

The buttons marked ▲ and ▼ are the strength controls. To increase strength, press and hold down the button ▲ until required strength is achieved. To decrease the strength, press and release the button ▼. To increase strength in steps of 1 mA, press and release the button ▲.

The unit will remain in the WORK part of the cycle for 5 seconds while intensity is being adjusted.

The strength levels are shown on the LCD.

The strength control buttons will not operate until the unit is properly connected to you (Kegel Trainer inserted correctly). Kegel Toner detects a disconnection and automatically returns the strength to zero.

The unit has 99 levels of strength. If you hold down the button ▲ for 3 to 5 seconds, the strength will start scrolling.

You may feel nothing over the first few presses. Continue pressing until the sensation is strong but comfortable. Further increases during use may be necessary if your body becomes used to the sensation.

The yellow LED on the output socket indicates that there is an active output. The display will remain on for 5 seconds after the plug is removed.

PROGRAMME CONTROL

The button marked P is the programme control. The Kegel Toner has two preset programmes. At first use, the unit automatically goes to programme

TRAIN. Next time it is switched on, it will default to the programme used last.

Each time you press and release the P button, the programme changes and is shown on the LCD.

Each time you change the programme, the strength level reverts back to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each programme gives a different sensation.

The LOCK BUTTON can be used to lock all controls except for the strength down ▼ and OFF buttons. To activate, press and hold down the P button for at

least 5 seconds until the lock icon is displayed on the screen. To deactivate, press and hold down the P button for at least 5 seconds until the lock icon is no longer displayed on the screen and is replaced by the programmeyou are using.

TREATMENT TIMER

Each time you switch on the Kegel Toner the length of time of your programme will automatically revert to 20 minutes.

During use the unit counts down the minutes which are shown on the screen. On reaching zero the unit will switch off.

By pressing and releasing the T button you can manually override and select a shorter treatment time of 10 minutes. You may wish to use this during your early training sessions.

The length of time that you have selected will be shown on the screen. The minutes will start to count down once you start the programme.

If you hold down this key for 5 seconds, you can PAUSE the timer, allowing you to interrupt the treatment session, and

resume it later. Press and release the T button to resume the session.

Return to main screen by pressing any other key.

LOW BATTERY

An empty battery symbol will show when you need to change the batteries. The unit will shut down about 2 minutes after this.

LEADS ALARM

The Kegel Toner monitors the connection and the contact between you and the Kegel Trainer, or the pads. This is to prevent sudden changes if a broken connection is re-made. If either of these goes outside of a standard range while the strength is above 20, the unit will flash LEADS, bleep three times, and return the strength to 0.

Check the lead and if necessary, lubricate the Kegel Trainer with a water-based lubricant. Please see section 11 for more troubleshooting tips.

MEMORY

The Kegel Toner has a Memory with three functions:

1) Programme Retention. When you switch the unit on, it will automatically start in the programme which was being used when it was switched off.

2) Usage. Press T and ▼ together and hold down for 3 to 5 seconds. The display will show the number of times the unit has been used and the duration of use in hours.

Press the same buttons again to return to normal controls.

3) Memory Reset. To reset memory to zero, hold down the T and OFF buttons together for 3 to 5 seconds.

19:50

Number of uses

Time used in hours

7.1. INSTALLATION OF BATTERIES

1) Remove battery cover by pulling on tag.
2) Insert batteries.

Ensure that the batteries are inserted the right way as shown in battery compartment and that the ribbon is behind them.

3) Replace battery cover.

Battery Warnings

Do NOT pierce, open, disassemble, or use in a humid and/or corrosive environment.

Do NOT expose to temperatures over 60^ C(140F).

Do NOT put, store or leave near sources of heat, in direct strong sunlight, in a high temperature location, in a pressurized container or in a microwave oven.

Do NOT immerse in water or sea water, or get wet.

Do NOT short-circuit.

Do NOT connect the device unless the battery cover is in place.

If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with lots of water and immediately seek medical attention.

Warning: Keep batteries out of the reach of children to prevent them from swallowing them by mistake. If swallowed by child, contact doctor immediately.

Caution NEVER attempt to recharge an alkaline battery. Risk of explosion.

Caution Do not mix old, new or different types of batteries as this may lead to battery leakage or low battery indication.

Disposal: Always dispose of batteries and device responsibly according to local government guidelines. Do not throw batteries onto a fire. Risk of explosion.

7.2. CONNECTING LEAD WIRE

Insert the lead wire plug into the base of the unit.

Connect the lead from the base of the unit to the lead in the Kegel Trainer. Push the pin ends firmly into the pigtail ends of the Kegel Trainer lead.

The lead wires may be damaged by rough handling and should be treated with care.

7.3. PREPARING FOR SESSION

1) Before using Kegel Toner, you will need to visit the toilet.
2) Lubricate the metal electrode surfaces and Kegel Trainer tip with a water-based lubricant, such as TensCare Go Gel or water.
3) Choose a comfortable position, such as lying down on your bed on your side with your knees raised.

Warning: Ensure the Kegel Toner is switched OFF before inserting the Kegel Trainer.

4) After wires are securely connected, insert the Kegel Trainer into the vagina, in the same way as a tampon, with the two silver plates side to side: one plate on left and the other on the right, until only the flange at the end is visible. The Kegel Trainer will naturally position itself with the widest part of the flange vertically.
5) The metal parts conduct the electrical pulse and should be in contact with the main part of the muscle at all times. The tissues close to the entrance are more sensitive, so you should avoid stimulating them.

Note: The flange should not be inserted into the vagina and should remain outside of the vagina at all times.

7.4. TRAINING SESSION

1) Press and hold the ON button on the control unit for 3 to 5 seconds to switch the control unit on.

2) You can select from the two preset programmes (see section 4). To change between the programmes, press the programme selector, which is labelled P.
3) With the required programme selected, you can adjust the intensity of the muscle stimulation until you reach a comfortable level. Once you have reached a comfortable level, 5 seconds after you stop pressing the button, the intermittent work/rest phase will start. The machine will take itself to 0 mA for a rest period and then take itself back up to the level of intensity you chose, to work the muscle. This cycle will continue for the 20 minutes of the programme.

Note: The strength required varies widely between users - some will use the Kegel Toner at full power – 99 mA. The Kegel Toner strength will go up at 1 mA increments.

Initially the sensation through the Kegel Trainer may be limited but will improve during treatment. Take care not to use too much strength and thereby over stimulate the muscles until normal sensation is restored. The sensation may not be even as it may vary depending on the sensitivity of the nerves.

The LCD display shows the strength of intensity used. The aim is to increase this over a few days. But remember there is no hurry, so only increase the strength of the stimulation as and when you are comfortable and ready to progress.

Note: If the sensation becomes uncomfortable, reduce the intensity using the button ▼.

When switched on, in TRAIN and TONE programmes the unit will go through an exercise programme for 3-5 seconds, followed by a rest period of 6-10 seconds. The Kegel Toner causes a sensation which feels like a strong drawing in of the vagina and pulling up of the pelvic floor. The natural reaction will be to pull in and up with the muscles.

At lower strength settings, you may not feel any sensation at all, this depends very much on the individual and any pre-existing physical conditions, so slowly increase the intensity by

repeatedly pressing the ▲ button until you begin to feel the muscles around your vagina contract.

For best results in these programmes try to contract the pelvic floor muscles along with the Kegel Toner, and to sustain the contraction into the rest interval. If possible, link the contraction to your breathing to get into a gentle rhythm.

Increase the strength as high as it is comfortable, and then take it back down one step. The strength display on the control unit will reduce to 0 and flash during the rest period.

The length of each session is automatically set to 20 minutes. The length of each session for muscle strengthening will also depend on your ability to contract and your resistance to fatigue. Be careful not to overuse early on, as the resulting aches may not be felt until the next day.

Note: If you experience cramping, switch the unit off until the symptoms go away then continue the session with the intensity set at a lower level.

When the timer reaches zero, your session is complete, and the unit turns off.

1) Check that the control unit is off. If it is not, hold down the OFF button to switch off then remove the Kegel Trainer from your vagina by holding the positioning end rim and gently pulling outwards. If you are using the pointer, detach this first before removing the Kegel Trainer.
2) Wash and thoroughly dry the Kegel Trainer and return it to the storage pouch.
3) The Kegel Toner will not only improve your pelvic floor muscles but also help you to recognise the correct sensation you need to feel when doing your Kegel exercises.

Note: When removing the Kegel Trainer, DO NOT PULL ON THE LEAD WIRE.

8. CLEANING

It is important that the Kegel Trainer is cleaned before using for the first time and after each use. Clean with either an alcohol-free antibacterial wipe or by washing with warm soapy water. Rinse in clean water and dry thoroughly and return the unit to the storage pouch. Do not immerse the Kegel Trainer in a liquid.

Clean the case of the unit and lead wire at least once a week using the same method.

• Do not immerse your Kegel Toner unit in water.
• Do not use any other cleaning solution.

9. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS

At the end of its life, please dispose of your Kegel Toner responsibly.

Anything electrical or electronic should not be treated as domestic waste and simply thrown away. About half of the states currently have laws on disposal and recycling of electronics. The Environmental Protection Agency makes recommendations for safe disposal of electronic waste on:

http://www.epa.gov/epawaste/conserve/materials/ecycling/index

10. ACCESSORIES

Expected Service Life

• The machine will often last for more than 5 years but is warranted for 2 years. Accessories (lead wire, Kegel Trainer, and batteries) are not covered by the warranty.
• Lead life depends greatly on use. Always handle the leads with care. We recommend to replace the lead wires regularly (about every 6 months).
• Replace the Kegel Trainer every 6 months to ensure hygiene.
• AA alkaline batteries should last about 18 hours of continuous use.

The following replacement parts may be ordered from TensCare at [phone] or www.tenscare.co.uk.

X-VPK Liberty Kegel Trainer (28 mm dia.)

Note: You should only use the Kegel Trainer supplied with the unit or the replacements above as performance may vary with other electrodes.

Warning: Do NOT use silicone based or hybrid (mixed water and silicone) lubricants.

11. TROUBLESHOOTING

If your Kegel Toner is not working properly, please check the following:

Problem	Possible causes	Solution
No display	Flat batteries.	Replace batteries.
	Batteries inserted incorrectly.	Remove plastic wrap Check + / - .
	Damaged springs in battery compartment.	Contact supplier.
Low battery display	Low batteries.	Replace batteries.
Controls won’t work	Keypad is locked.	If the lock icon is shown on display. Press and hold the F button for at least 5 seconds. If no LOCK is showing, remove and replace the batteries.
No sensation and LEADS alarm showing	The Kegel Toner has a safety feature which will not allow the intensity to pass 20 mA if the machine detects a connection error. If a connection error is detected the intensity will return to 0 mA and the screen will flash LEADS. This safety feature will prevent the machine from giving any uncomfortable stimulation should the contact break between the machine and your skin. This will also prevent anyone from increasing theintensity to a high level without firm contact between the machine and the skin.A connection error can occur if:
	1. A break has developed within one of the two lead wires.	If this happens, you can try to test the unit by holding the Kegel Trainer in your hand:Dampen your hand with water and a little table salt. Squeeze the Kegel Trainer firmly and make sure your skin is covering the metal parts of the Kegel Trainer and carefully increase strength until you can feel something. Most people will start to feel the stimulation in their hand at around 25 mA.If the LEADS alarm shows and the unit will not allow you to pass 20 mA. The lead wires need to be replaced.
	If you have tried the test above and DO have sensation when the Kegel Trainer is in your hand, then it may be that:2. The skin is dry, meaning poor conductivity between the metal plates on the Kegel Trainer and your skin.	If this happens, you can try the below solutions:Using a water-based lubricant), which will improve conduction. Crossing your legs and squeezing to increase pressure on the Kegel Trainer, which should improve the connection. If this enables you to use the unit, you should find that in a few weeks of stimulation the contact improves. If it does not, this unit may not be suitable for you. You may need to contact your healthcare professional to discuss other suitable options.The Kegel Trainer supplied with the unit has a 28 mm diameter. An optional 32 mm Kegel Trainer, part no. X-VPM, is available.
No sensation and no LEADS alarm showing	Intensity level is not high enough and/or reduced sensitivity in the area being treated.	lease make sure you are increasing the intensity high enough. Most people will start to feel the stimulation in their hand at around 25 mA and with the Kegel Trainer inserted you will need to increase the intensity higher to around 40 mA – 60 mA. Max power is 99 mA. Everyone is different so ust keep increasing the intensity until you can feel it. The intensity increases in very small steps of 1 mA. You may have reduced sensitivity due to previously damaged or desensitized pudendal nerves (this can happen in childbirth or some surgical procedures). Please consult your healthcare professional.
No sensation on one side of the Kegel Trainer (or electrode)	Position is not optimal – needs adjusting.	The current flows from one side of the Kegel Trainer to the other, so it is not possible to have one side “not working”. However, the strength of the sensation depends on how close to the nerve the curren flows, and also in which direction it flows relative to the nerve. You can try slightly adjusting the position on the Kegel Trainer, or exchanging the connection of the wires in the Kegel Trainer.
Sudden change in sensation	If you disconnect and re-connect after disconnecting the lead of few minutes later, the signal will feel quite a lot stronger.	Always return strength to zero after disconnecting the lead of the Kegel Trainer.

The patient is an intended operator. There are no user-serviceable parts inside the unit, and no calibration is required.

If the above review has failed to resolve your problem, to report unexpected operation or events, or to provide feedback call TensCare or your local dealer (address on back cover) for advice.

European Medical Device Regulation requires that any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority in your country. This can be found at:

https://ec.europa.eu/docsroom/documents/36683/attachments/1

/translations/en/renditions/pdf

1. GENERAL SPECIFICATION

Waveform	Asymmetrical rectangular
Amplitude	99.0 mA (over 500 Ohm load)+/- 10%
Max intensity	50V zero to peakConstant voltage over 470-1500 OhmConstant current over 160-470 Ohm
Output plug	Fully shielded
Channels	Single channel
Batteries	2 x AA alkaline (two AA batteries) or 2 x AANiMH
Weight	75 g without batteries
Dimensions	120 x 60 x 20 mm
Safety Classification	Internal power source.
Environmental Specifications:
Operating:	Temperature range: 5 to 40°CHumidity: 15 to 93% RH non-condensingAtmospheric pressure: 700hPa to 1060hPa

Contact duration: At least 10 minutes.

Note: The electrical specifications are nominal and subject to variation from the listed values due to normal production tolerances of at least 5%.

Device output parameters

The waveform below demonstrates a typical output waveform form the Kegel Toner device: Max Pulse Energy: 23 C Use special precautions regarding EMC according to the

information provided below. Other portable and mobile RF communications equipment can affect performance. Do not use when adjacent or stacked with other electrical equipment.

13. EMC

Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment. (Note. As indicated in Table 6 of IEC 60601-1-2:2007

for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m). Use special precautions regarding EMC according to the information provided below.

• Other portable and mobile RF communications equipment can affect performance.
• Do not use when adjacent to or stacked with other electrical equipment.
• Use of leads or probes other than those listed in section 10 may affect EMC performance.

Note: For hospital use, full EMC advice tables are available on request.

Simple line drawing of a flag and a bulb-like shape with a dark center, no text or symbols present.

Illustration of a human leg and a blood glucose meter device (no text or symbols present)

ONE 20 0 Button P 4

web:www.tenscare.co.uk/continence/kegel-toner

ÍNDICE

1. INTRODUCCIÓN 29
2. INDICATIONS FOR USE 29
3. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS 30
4. PROGRAMAS 35

4.4. PROGRAMAS PREESTABLECIDOS ..... 35

2. INDICATIONS FOR USE

https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/en/renditions/pdf

Simple line drawing of a flag and a stylized object with a dark oval shape inside, no text or symbols present.

Illustration of a human leg and a blood glucose meter device (no text or symbols present)

L'emballage contient:

• 1 x stimulateur d'incontinence Kegel Toner
  • 1 x Fil de raccordement (L-CPT)
  • 1 x Liberty Kegel Trainer (X-VPK)
• 2 x piles alcalines AA 1,5V
• 1 x Pochette de rangement

6. INFORMATION SUR L'UNITÉ

6.1. COMMANDES ET AFFICHAGE

Keypad Lock Low Battery ON button OFF button Time selector Output active indicator 20 min TRAIN mA Program duration (min) Program selected Strength selected (mA) Program selector Strength up Strength down Kegel Toner

6.2. MODE D'EMPLOI

ON/OFF

https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/en/renditions/pdf

1. SPÉCIFICATION GÉNÉRALE

Simple line drawing of a flag and a bulb-like shape (no text or symbols)

Illustration of a human leg and a blood glucose meter device (no text or symbols present)

Symbol of a trash bin crossed with no text or labels, accompanied by a black rectangular block below (no readable text or symbols)

http://www.epa.gov/epawaste/conserve/materials/ecycling/index

10. ZUBEHÖR

https://ec.europa.eu/docsroom/documents/36683/attachments/1

/translations/en/renditions/pdf

1. ALLGEMEINE SPEZIFIKATION

TensCare aim to give you the best possible product and service. We listen to your suggestions and are constantly trying to improve our products. We also want to learn about the way our products are used, and the benefits they give. If you have anything you would like to share with us, please get in touch.

www.tenscare.co.uk

Follow us:

TensCare Ltd

@TensCareLtd

TensCare Limited

@tenscareltd

EC Declaration of Conformity

CE 2797

Tenscare Ltd herewith declare that the product meets the provisions of REGULATION (EU) 2017/745 which apply to it. The medical device has been assigned to class IIa according to Annex IV of the REGULATION

(EU) 2017/745. The product concerned has been designed and manufactured under a quality management system according to Annex IX, of REGULATION (EU) 2017/745. This EU declaration of conformity is issued under the sole responsibility of the manufacturer. No “Common Specification” is applicable.

Distributed by:

TensCare Ltd.

9 Blenheim Road, Epsom.

Surrey, KT19 9BE, UK

[phone]

www.tenscare.co.uk

EC REP

Advena Ltd.

Tower Business Centre.

2nd Flr. Tower Street,Swatar,

BKR 4013, Malta

TensCare Europe BV