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0473
EC Declaration of Conformity
TensCare Ltd hereby declare that an examination of the production quality
assurance system has been carried out following the requirements of the
UK national legislation according to Annex V of the Directive 93/42/EEC on
medical devices. We certify that the production quality system conforms
with the relevant provisions of the aforementioned legislation, and the result
entitles the organisation to use the CE 0473 marking on this product.
Distributed by:
Pub Ref: I –MT-UK Rev2 6/14
TensCare Ltd, 9 Blenheim Road,
Longmead Business Park,
Epsom, Surrey KT19 9BE, UK
Tel +44(0) 1372 723434
Email: ask@mama-tens.info
www.mama-tens.info
0473
"TIMED, CONTROLLED
PURE POWERFUL
PAIN RELIEF"
I n s t r u c t i o n s f o r U s e
PL EA SE READ THIS B EF OR E YOU GO INTO LAB OU R
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Summary of Contents for TensCare mamatens my time
- Page 1 PAIN RELIEF” 0473 EC Declaration of Conformity TensCare Ltd hereby declare that an examination of the production quality assurance system has been carried out following the requirements of the UK national legislation according to Annex V of the Directive 93/42/EEC on medical devices.
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Page 2: Table Of Contents
Quickstart Guide Contents Section Page Introduction and Features How “TENS” works The Programmes Read instruction book carefully Check contents PressON button to check that Contraindications the unit is working (LCD will be activated) then switch OFF Cautions and Warnings Controls Screen Display Contents Installation of Batteries... - Page 3 1. INTRODUCTION MamaTENS “My Time” Special features: • The MamaTENS “My Time” is a very MamaTENS “My Time” LABOUR LOG special maternity TENS as it not only offers Labour Log enables you to monitor the duration and frequency of your contractions by measuring each one in seconds and showing the time powerful controllable pain relief, but also between them.
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Page 4: How "Tens" Works
MamaTENS “My Time” other features: 2. HOW “TENS” WORKS • Preset programmes and intelligent “Active Power” ramp TENS stands for Transcutaneous Electrical Nerve Stimulation. The MamaTENS “My Time” has 2 preset programmes. These programmes TENS stimulates your body’s own natural defences against pain. have been clinically proven to give relief from labour pain. -
Page 5: The Programmes
TENS sends a very small electric current through the skin 3. THE PROGRAMMES which works in THREE ways: The i-touch MamaTENS has 2 preset and a Power Ramp programme. Pain Gate Each of the two preset programmes is in two forms First preset programme is shown on the screen as “A Int”... -
Page 6: Contraindications
Some mothers can go right through their whole labour using only the “A” 4. CONTRAINDICATIONS programmes. Other mothers will want to change to the “B” programmes as the pain increases to moderate. Do this by pressing the “P” (Programme) Before using mamaTENS Mytime, please read the following button once. -
Page 7: Cautions And Warnings
5. CAUTIONS & WARNINGS • Across the front of the head. Effect on patients who have had strokes or seizures is not known. May Caution: affect sense of balance. The effects of stimulation of the brain are • Observe caution when using the mamaTENS at the same time as being unknown. - Page 8 6. MAMATENS My Time CONTROLS On Button To switch unit on: Press and hold down for 3 seconds. When the unit is switched ON an audible “Beep” will be heard. One Touch Memory Start When switched on the unit will automatically...
- Page 9 Programme Button BOOST Button The MamaTENS “My Time” has specially Press the Boost button when your contraction selected programmes. When you FIRST switch begins, to change the mode from Int to Con. on the unit, it starts in programme A. Each Press again when you want to return to Con.
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Page 10: Screen Display
7. SCREEN DISPLAY Duration Shows the length in seconds of your last contraction. The counter starts when you press the Boost button to start “Con” mode to the time you press it again to return to “Int” mode. It continues to show the time until the start of your next contraction. -
Page 11: Installation Of Batteries
8. CONTENTS 9. INSTALLATION OF BATTERIES • Remove Battery Cover MamaTENS “My Time” maternity unit. • Pack of maternity pads with integral mono leadwire Press down in centre of battery cover and (item code E-CM50100IT-NEW). slide backwards in direction of raised arrows. •... -
Page 12: Connecting Mono Leadwire
10. CONNECTING MONO LEADWIRE 11. POSITIONING THE PADS (continued) Insert the Mono leadwire plug into the base 4. Place the top pair of pads (with white leads) either side of the of the unit. Please note that it has been spine about 4 inches (100mm) apart from each other just below designed to only insert one way. -
Page 13: When Your Labour Starts
12. WHEN YOUR LABOUR STARTS 8. If the pain goes deep, normally when you are in the later stages of labour, then in between contractions press the Programme button and the unit will go to “B int” at zero strength. The strength will To get the best results from your MamaTENS “My Time”... -
Page 14: Extra Pain Relief
13. EXTRA PAIN RELIEF 14. GENERAL INFORMATION If the level of pain becomes extreme or if you did not start using the TRIAL RUN unit sooner enough to allow for the full endorphin release then it is It is recommended that you have a trial run with your MamaTENS suggested that you go to programme “C AP”. - Page 15 PAD ALARM POST NATAL USE The MamaTENS “My Time” monitors the condition of the pads during use and the quality of the connection to the body. If If you are in pain following the birth, you can obtain further releif either deteriorates to a point where the stimulation is affected from the MamaTENS “My Time”.
- Page 16 BATTERY REMOVAL AND REPLACEMENT RETURNING YOUR RENTAL UNIT When the batteries need to be changed, the low battery sign, If you rented your mamaTENS MyTime your machine should have “BATT”, will be displayed on the screen. To remove batteries, pull been sent to you three weeks before your due date.
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Page 17: Guarantee
Lead faulty/damaged Purchase replacement if necessary If the above review has failed to resolve your problem, call TensCare or your local dealer (address on back cover) for advice. Or if you have any questions or need more information you can contact TensCare at anytime via our website, www.tenscare.co.uk... -
Page 18: Consumables And Servicing
For units before 5140001, we are using part number E-CM50100IT waste and simply thrown away. To remind you of this Directive all Please note: these are the part numbers according to the TensCare website. affected products are now being marked with a crossed-out wheelie These are available from either your supplier or by ringing bin symbol, as depicted below. -
Page 19: Technical Specifications
19. TECHNICAL SPECIFICATION Environmental Specifications: Operating: Temperature range: 5 to 40C: 15 to 93% RH non-condensing Waveform Asymmetrical Bi-Phasic Storage: Temperature range: -25-+70C RH 93% Humidity non condensing Amplitude (over 500 ohm load) 70mA zero to peak +ve in steps of 0.5mA Contact Duration: at least 10 minutes Constant current over 500-1500 Ohm... -
Page 20: Emc Precautions
The mamaTENS is intended for use in the electromagnetic environment specified below. The customer 20. EMC PRECAUTIONS or the user of the mamaTENS should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment – guidance test level level Use special precautions regarding EMC according to the information provided below.
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