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Nov 2020 (7)

Body Clock Health Care Ltd108 George Lane, South Woodford

London E18 1AD

Tel (+44) (0)20 8532 9595

Fax (+44) (0)20 8532 9551

www.bodyclock.co.uk

e-mail customercare@bodyclock.co.uk

This manual is recyclable

Using Your SensaTONEFor PFS

PFS - Pelvic Floor Stimulation

a) Switch the unit on by pressingthe Power Key button. TheSensaTONE will always start upin Mode A.

b) The SensaTONE has fourpreset programmes:

Mode A - Urge IncontinenceMode B - Stress IncontinenceMode C - Mixed IncontinenceMode D - After Care

c) Select the mode mostappropriate for your type ofincontinence by pressing the‘MODE’ key. Please refer topage 9 if you are unsure ofwhich mode to use.

d) Now begin by pressing the‘Intensity Up’ key. Each timeyou press this key, you will seethe intensity level increase onthe LCD.

e) Carefully continue to press‘Intensity Up’ key until youcomfortably feel your musclescontracting. If the sensationfeels too strong, simply pressthe ‘Intensity Down’ keyminimise the feeling.

f) Modes A, B and C all have fixedprogramme times. TheSensaTONE will automaticallyswitch off once the programmeis complete. Mode D does nothave a fixed programme time.Refer to page 9 for moreinformation about Mode D.

g) After use, always remember toensure that the SensaTONE isswitched off. Then remove theSensaTONE probe from yourbody, disconnect the leads andthen clean it in accordance withthe instructions found on page6 or in the SensaTONE probeinstruction manual.

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Choosing The RightPFS Mode

There are three types ofincontinence, all of which can betreated with the SensaTONE:1. Urge incontinence (MODE A) -

occurs with a strong, suddenand uncontrollable urge tourinate.

2. Stress incontinence (MODE B) -occurs when sneezing,coughing, laughing, lifting orduring exercise and causes asmall amount of urine to leak.

3. Mixed incontinence (MODE C)- a combination of urge andstress incontinence.

Frequency Of Use

Below is a guide showing howoften to use each PFS mode onyour SensaTONE. If your muscles

start to ache, or you have anyproblems using the SensaTONE,please contact your medicaladviser.

Using Mode D – After Care

This is an optional mode and canbe used as follows:• Directly after treatment with the

SensaTONE, provided you are notexperiencing any muscle fatigue.

• As a maintenance mode afteryou have been using thesensatone on a regular basisand have experienced animprovement in your condition.

Please note that there is norecommended treatment time forthis mode. It is at your discretion.It is suggested that it is used nomore than between 15-30 minutesper day.

PFS - Frequently AskedQuestions

Q How long will it take to seeresults?

A The amount of time variesfrom woman to woman; it isalso dependent on the type ofincontinence from which youare suffering.STRESS Incontinence -improvement comesslowly with the buildingof muscle fibre andnerve sensitivity. This cantake up to 2 months.URGE Incontinence -improvements are made byreducing the false signalssent by the bladder to thebrain. Results can be seen inas little as 14 days.MIXED Incontinence -improvements are madeby building the muscle fibreand nerve sensitivity as wellas reducing the false signalsbeing sent to the brain. Thiscan take slightly longer, butyou should be able to notice a difference within 21 days.

Q What does it feel like?A All three PFS programmes feel

slightly different. In general,the feeling is that of apleasant, tingly, squeezingsensation that contracts andrelaxes the pelvic floormuscles.

Q Is it suitable for use by allwomen?

A Yes, all women can use itprovided none of thecontraindications apply.

Q Can I use it whilst I’mpregnant?

A No, not until 12 weeks afterthe birth.

Q Are there any side effects?A No, it is totally drug free. There

are no known side effects.

Before first use of theSensaTONE, pleasefamiliarise yourselfwith the ‘Precautionsand Contraindications’contained on page 4.

The SensaTONE shouldNOT be used:

• During pregnancy.• During the menstrual period.• If you suffer a urinary or

vaginal infection.• At the same time as a barrier

contraceptive device such asa diaphragm or cervical cap.

• Until 12 weeks after childbirth.

Programme

Mode A

Mode B

Mode C

Mode D

Length

30 mins

30 mins

45 mins

–

How often

1-2 times a day

Complete the programme once a day

Once a day or every other day depending on severity

Please see ‘Using Mode D’ above

DO NOT EXCEED TREATMENT TIMES UNLESS ADVISED BY A MEDICAL PROFESSIONAL.

If you have any furtherquestions onincontinence or needsome advice, contactThe Bladder and BowelFoundation on:

Helpline: (+44) (0)845 345 0165

e-mail:info@bladderandbowelfoundation.org

web:www.bladderandbowelfoundation.org

Reg Charity1085095

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Programme Display Output Frequency/Duration

5Hz / 3 mins 10Hz / 5 mins 15Hz / 5 mins20Hz / 5 mins 15Hz / 5 mins 10Hz / 5 mins 5Hz / 2mins

Total time = 30 mins

Urge A

10Hz / 5 mins 35Hz / 5 mins 50Hz / 10mins35Hz / 5mins 10Hz / 5mins

Total time = 30 mins

Stress B

10Hz / 5mins 20Hz / 5 mins 30Hz / 5 mins40Hz / 5mins 50Hz / 5mins 40Hz / 5mins30Hz / 5mins 20Hz / 5mins 10Hz / 5mins

Total time = 45 mins

Mixed C

Frequency Modulation

Frequency increases from 2 Hz to 10 Hz in 4 secs. and then back to 2Hz in another 4 secs.

Total cycle = 8 secs Total time = 45 mins

After Care D

All outputs have 200µs pulse width. For the Urge, Stress and Mixed mode,the output pulses are alternatively switched on and off for 5 seconds.

Specifications

Output Channel Single Channel

Output Waveform Bi-phasic rectangular

Output Voltage 0-40V adjustable in 14 steps across a 500 ohm load

Output Intensity 0-80mA adjustable in 14 steps across a 500 ohm load

Automatic Power Off 5 minutes

Battery 2 x 1.5v AAA Batteries

Battery Low Detect 2.2V±0.1V

GuaranteeYour SensaTONE machine is guaranteed for a period of 2 yearsagainst manufacturer’s defects. Please record purchase detailsin the space provided below for your record purposes. Theguarantee does not include leads, electrodes, probes or battery.

Date of purchase:

Invoice number:

1639Model: D-BC06TA

Saverine Medical LtdNorth Point House

North Point Business Park Old Mallow Road,

Cork, Ireland.

EC REP

SensaTONEInstructions for use

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The SensaTONE fromBody Clock is an ultrasimple, yet powerfuldigital Pelvic FloorStimulator (PFS). Thiscompact, stylish unithas been designed foruse by women of allages to help strengthenpelvic floor muscles andto treat incontinence.

Like all other muscles in yourbody, the more you stimulatethem, the stronger they become.Women with strong pelvic floormuscles enjoy greater controlover their bladder, increasedvaginal tone and greatersensation during intercourse.

One in three women suffers fromsome form of incontinenceduring her life. It can occur at anytime, most commonly afterchildbirth. The severity ofincontinence can vary.

Before you use the SensaTONE,it is important that you read thismanual carefully; it contains allof the information you need toensure you are using theunit safely and correctly.

Explanation Of Symbols On Unit

Equipment providing aparticular degree ofprotection againstelectric shockparticularly regardingallowable leakagecurrents having a BFtype (floating) appliedpart.

Warning – refer toaccompanyingdocuments i.e.these instructions.

Please keep deviceaway from sprays ofwater or rain.

Denotes a product which must be disposed of safely.

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Contents

Precautions And Contraindications ...................................................... 4

Controls On The SensaTONE ................................................................ 5

Display Symbols And Their Meanings .................................................. 5

Additional Functions ............................................................................ 5

Setting Up Your SensaTONE ................................................................ 6

Useful Diagrams .................................................................................. 7

Using Your SensaTONE For PFS ............................................................ 8

Choosing The Right PFS Mode ............................................................ 9

Frequency Of Use .................................................................................. 9

Using Mode D – After Care .................................................................... 9

PFS FAQ’s ............................................................................................ 10

Technical Specification ........................................................................ 11

Precautions AndContraindications

1. Do NOT use the SensaTONE if youhave a cardiac pacemaker.

2. Check with your medical adviserbefore using if you suffer from aheart condition, undiagnosedpain, have any metal implants, orany doubts whatsoever.

3. The SensaTONE can NOT be usedduring pregnancy. You can use itfrom 12 weeks after the birth.

4. Do NOT use the SensaTONE if yousuffering from any urinary orvaginal infection.

5. Do NOT use the SensaTONE at thesame time as a barriercontraceptive device such as adiaphragm, cervical cap or coilwithout first checking with themanufacturer of the coil toestablish that the two devices aresafe to use together.

6. Never use the SensaTONE tomask undiagnosed pain since thiscould require urgent treatment.

7. The SensaTONE should NOT beused during the menstrual period.

8. Remove the vaginal probe aftertreatment.

If you have any concerns regardinguse of the SensaTONE please do nothesitate to contact Body Clock HealthCare on (+44) (0)20 8532 9595.

General Precautions

1. Do NOT use this unit without firstreading these instructions.

2. Do NOThandle or insert probeunless the unit is switched off.

3. Do NOT immerse unit in liquid.4. Do NOT place it close to any source

of excessive heat or operate it inthe presence of flammable gas.

5. Do NOT drop this unit onto a hardsurface.

6. Do NOT attempt to dismantle theSensaTONE.

7. Only use specified batteries andelectrodes.

8. If damaged, do not use. Return tosupplier.

9. Remove batteries when not in use.10. Do NOT use while driving or

operating potentially dangerousmachinery or while using amicrowave.

11. Keep out of the reach of children.12. Do NOT place the vaginal probe

near the eyes, in the mouth, overthe front or sides of the neck,across the head, heart.

13. Do NOT use in the presenceof tuberculosis, malignanttumours, very high or low bloodpressure, high fever or acuteinflammatory disease unless undermedical supervision

14. Do not use this device on infants orpeople not capable of expressingtheir intentions.

Controls On The SensaTONE

Power Key – Turns the SensaTONE onand off.User Display – Indicates the mode inuse and the intensity level (also seediagram below).

Mode Key – Switch betweenprogrammes A, B, C and D.

Intensity Up – Increases the intensityof the pulses.

Intensity Down – Decreases theintensity of the pulses.

User Display

Additional Functions

Load Detector – If the vaginal probe becomes detached, the intensity will dropback to zero.Low Battery Indicator – A flashing battery symbol will be shown on the display.Automatic Power Off – When the unit intensity levels are zero, and theSensaTONE has not been in use for about 5 minutes, the unit will shut offautomatically.

Indicates themode in use.

Indicates theintensity levelof the pulses.

Low batteryindicator.

Setting Up YourSensaTONECheck you have the followingcontents:

• 1 x SensaTONE unit

• 1 x SensaTONE vaginal probe

• 1 x Leadwire

• 1 x Lubricant gel sachet

• 1 x Neck cord• 1 x Instructions

NB. batteries not included

The Assembly Stage

1. Ensure the SensaTONE unitis switched off.

2. Slide open the battery coveron the back of the unitto expose the batterycompartment.

3. Insert the batteries matchingthe + and – terminals,according to the diagramfound in the batterycompartment. Replace thecover.

4. Remove the SensaTONEvaginal probe from itspackaging.

5. Wash hands in soap and warmrunning water. Liberally washthe probe using the samemethod but do not soak. Rinseall soap and residue fromhands and probe. Dry yourhands and the probe with aclean cloth/paper towel andallow to air dry.

6. Insert the end of the leadwireinto the socket at the bottomof the SensaTONE. Connect theother end of the leadwire tothe probe. See diagram (i) onpage 7.

7. Apply a thin coating oflubricating gel to the probe.

8. Insert the probe until theflange at the base of the probeis sited between the labia.There is no need for preciseorientation. See diagram (ii)on page 7.

9. You are now ready to beginstimulation.

pelvic floor muscle

urethra

vagina

anus

Diagram (i)

Diagram (ii)

probe

Useful Diagrams

Important• The SensaTONE vaginal probe is single patient use ONLY.

Additional probes and gel can only be purchased from Body Clock.• Probes may be re-used by the same patient only.• Wash probe as instructed before each use.• Do NOT use the probe if the pack is open or damaged.

This unit needs special precautions regarding EMC andneeds to be installed and put into service according tothe EMC information provided in the ACCOMPANYINGDOCUMENT.

This symbol indicates the serial number of the device. It can be found in the battery compartment and outer packaging. It includes the year of manufacture (YOM) which appears as two digits after the letters FD e.g. FDXX. The digits following the YOM identify each individual device.

EU Representative.