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Contraindications, General precautions & adverse reactions, Warnings – Babycare TENS Elle TENS User Manual

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Contraindications

1. Do NOT use TENS before 37 weeks of pregnancy unless under medical supervision.

2. Electrodes should only be positioned as recommended for childbirth (see page 7),

unless otherwise stated by your midwife or medical adviser.

3. Do NOT place electrodes on the abdomen (before birth), the front or side of the

neck, or areas on the head, which could cause current to flow transcerebrally.

4. Do NOT use TENS if you have a demand-type cardiac pacemaker.

5. If you suffer from or any undiagnosed pain, have any metal plates or any doubts

whatsoever consult your medical adviser.

6. Never use TENS to mask undiagnosed pain as this could require urgent treatment.

7. The unit MUST NOT be used for Pelvic Floor Stimulation in any mode or with the

Vaginal Probe during pregnancy.

8. You can only use the unit for Pelvic Floor Stimulation from at least 12 weeks after

childbirth. Check the appropriate time with your medical advisor.

9. Do NOT use the Elle TENS+ for Pelvic Floor Stimulation with the Vaginal Probe if

you are suffering from any urinary or vaginal infection, or at the same time as

using a barrier contraceptive device such as a diaphragm or cervical cap, or during

your menstrual period.

General Precautions & Adverse Reactions

1. Do NOT use this unit without first reading these instructions.

2. Do NOT immerse the Elle TENS+ in any liquid.

3. Do NOT place it close to any source of excessive heat or operate it in the presence

of flammable gas.

4. Do NOT drop this unit onto a hard surface.

5. Do NOT attempt to dismantle the Elle TENS+.

6. Only use specified batteries, electrodes and probe.

7. If damaged, do not use. Return to supplier.

8. Remove the batteries when not in use.

9. Do NOT use while driving or operating potentially dangerous machinery.

10.Do NOT use in close proximity (e.g. 1m) to shortwave or microwave therapy

equipment to avoid instability in the stimulator output.

11. Do NOT use adjacent to or stacked with other equipment.

12.Keep out of the reach of children.

13.DO NOT place electrodes or vaginal probe across or through the head, directly or

near the eyes, covering the mouth, on the front or sides of the neck (especially

the carotid sinus), on the chest and upper back so as to cross over the heart,

directly over your heart or an area of broken, inflamed, infected or numb skin.

14.Electrodes should only be applied to skin with normal sensation unless under

medical supervision as skin irritation may occur following long term application.

15.This is an internally powered medical electrical equipment. Do not use battery or

power sources other than those specified in these instructions

16.No modification of this equipment is allowed.

Warnings

1. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not

operate properly when TENS is in use. Portable and mobile RF communications

equipment can affect medical electrical equipment. Operation of the equipment or

system below this amplitude or value may cause inaccurate results.

2. Mild temporary skin irritation can occur following long term application.

Simultaneous connection by the user to a high frequency surgical medical

electrical equipment may result in burns at the site of the electrodes and

equipment. Users should seek advice from their medical advisors when use of this

equipment is required.

3. Keep out of the reach of children and babies at all times. Children and babies may

be at risk of strangulation by entaglement in leadwires or choking by swallowing

small parts or accessories. Ensure that from the device and all accessories are

stored away safely out of the reach of children and babies at all times.

4. It is unsafe to use accessories, detachable parts and materials not described in

these instructions for use. Please see www.bodyclock.co.uk for suitable

accessories or contact us if you require any spare parts on +44 (0)20 853 9595.

5. Do not interconnect this device with any other equipment not described in these

instructions for use.

6. Do not modify this equipment in any way.

7. The device shall not be serviced or maintained while in use with a patient.

8. The Elle TENS+ is not user repairable and must be returned to the manufacturer if

it requires repair.

If you have any concerns please do not hesitate to contact Babycare TENS at

[email protected].

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