Babycare TENS Elle TENS 2 User manual

Instructions for use
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The instructions in this manual are designed to
cover most operational issues. If you have any
questions concerning setting up, using or
maintaining this device which are not covered by
these instructions or any other concerns please do
not hesitate to contact Babycare TENS at
[e-mail] alternatively, you can call
0333 1219 737 during our office hours.
TENS is recognised as a safe and highly effective
method of pain relief and is regularly recommended
by medical professionals.
TENS is drug-free, with no known side effects.
It can also be used in conjunction with any
additional medication if required.
Explanation of symbols on unit
Equipment providing a particular degree of protection against electric
shock particularly regarding allowable leakage currents having an F
type (floating) applied part.
Warning -
Please read these instructions before use particularly pages 17-18.
Denotes a product which must
be disposed of safely.
Please keep device away fromsprays of water or rain.
The first number 2:
Protected against access to hazardous parts with a finger, and the
jointed test finger of12 mmФ,80 mmlength, shall have adequate
clearance from hazardous parts, and protected against solid foreign
objects of 12.5 mmФand greater.
The second number 2:
Protected against vertically falling water drops when enclosure 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.
The Elle TENS 2™is an efficient method of drug-free pain relief. This powerful digital TENS unit
is smooth, sophisticated and simple to use. It has been cleverly crafted by Babycare TENS specifically for home
use for mums-to-be, for the management of pain for labour and beyond. The Elle TENS 2 contains all of the
award winning features of its predecessor, the Elle TENS, plus a built-in contraction timer, updated user interface
and backlight. The Elle TENS 2 is ready for all of your labour and post-natal needs.
2
IP22
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What is TENS?
TENS (Transcutaneous Electrical Nerve Stimulation) works
by passing mild electrical impulses through the skin, via
electrode pads, into the nerve fibres which lie below.
The TENS impulses help your body produce its own pain killing
chemicals, such as endorphins. The level of pain relief obtained
varies from person to person.
What can the Elle TENS 2
be used for?
1. The Elle TENS 2 provides pain relief during labour. owever
some people may find that other analgesics are also
needed during the later stages of labour.
2. The Elle TENS 2 can be used for many chronic and acute
pain conditions such as back pain, shoulder pain, arthritis,
sciatica, sports injuries, migraine, period pain and post-
operative pain.
3
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For more information
Please also refer to your
‘Women’s guide to drug free
pain relief’*.
*only if you have purchased this unit.
Waiting for that big day to finally arrive is exciting, but it is perfectly
natural to feel a little apprehensive. You will be thinking about how to
make giving birth as easy as possible - preparation is essential.
Babycare TENS has become the most popular choice for mums-to-be as it is specifically
designed to combat pain during childbirth. This is a safe, effective drug-free method of pain
relief, which still allows you to use other analgesics, such as pethidine or gas-and-air if you
wish.
Contents
4
Introduction 2
What is TENS? 3
What can the Elle TENS 2 be used for? 3
Controls on you r Elle TENS 2 5
Display symbols and their meanings 6
Setting up your Elle TENS 2 7
Suggested electrode placement diagram 9
Using the Elle TENS 2 10
Adjusting intensity for pain
relief during labour 10
Burst (use between contractions) 11
Boost (use during contractions) 11
Using the contraction timer 12
Recalling your contraction history 12
The Mode Button 13
The Opti-Max Key 14
Questions, answers and troubleshooting 15
Technical Specification 16
Contraindications, precautions
and warnings 17
System performance,
maintenance and care 18
EMC Information 19
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5
Controls on your Elle TENS 2
The Elle TENS 2 is very simple to use.
owever, it is essential to read these
instructions to obtain the most out of
the unit.
Please ensure that all of the
contraindications and precautions
have been read thoroughly.
See pages 17-18.
On/Off Button
N.B. Automatic Power Off
When the intensity levels are zero,
and the Elle TENS 2 has not been in
use for 5 minutes, it will shut off
automatically.
Channel 2 Intensity
Adjustment Keys
Channel 1 Intensity
Adjustment Keys
Opti-Max Key
Adjusts depth of the pulses:
Refer to p14 for more details.
Mode Button
Selects modes.
Space to attach neck cord
Boost/Timer Button
Used for an extra surge of
power during contractions and
also activates Contraction
Timer.
LCD automatically
lit by backlight
Leadwire ack Plug Sockets
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6
Low Battery Indicator
This sign will start flashing if the
batteries run low. If this is the case,
change both batteries. Please refer
to page 7 for instructions.
Power Bar
This shows the output from 0 to 15
for both channel 1 and 2. Each
segment represents approximately
7% of the total output.
Contraction Timer
Starts by pressing the Boost Button.
This automatically records the
duration of your contractions.
Opti-Max
Indicates the Opti-Max output.
Refer to page 14 for more details.
Pad contact warning
(safety cut-out)
This symbol will appear if any of
your pads are not attached securely
to the skin.
Mode 1 and 2
There are two mode ranges available
each with a Burst and Boost function
(see page 13).
BURST
This function is used at the onset
of labour and in between
contractions. There are two Burst
modes available indicated by a 1
or 2. You can switch between
them by pressing the Mode
Button (see page 13).
BOOST
The Boost Button at the top right
of the unit activates the BOOST
mode. This function is used during
contractions. There are two Boost
modes available indicated by a 1
or 2. You can switch between
them by pressing the Mode
Button.
Between Contraction Timer
Starts by pressing the Boost
Button. This automatically
measures the time interval
between your contractions.
Display symbols and their meanings
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+
AA R6 1.5v
+
AA R6 1.5v
+
AA R6 1.5v
+
AA R6 1.5v
Setting up your Elle TENS 2
7
Check the following contents:
• 1 x Elle TENS 2 Unit
• 1 x Pack of 4 Self Adhesive Electrodes
(40mm x 100mm)
• 2 x Leadwires and 1 Spare
• 2 x AA Batteries and 2 Spare
• 1 x Carrying Pouch
• 1 x Easy-Release Neck Cord
• 1 x Instruction Manual
• 1 x Quick Start Guide
• 1 x Women’s Guide*
*(only if you have purchased this unit)
The Assembly Stage
a) Press and rotate the belt
clip at the back of the Elle
TENS 2 in either direction
to reveal the battery
compartment.
b) Release the battery
compartment cover and
insert 2 x AA batteries
ensuring the positive (+)
and negative (-) terminals
are correctly positioned as
marked in the battery
compartment.
Replace the cover.
Press
Cover
Release
Rotate
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5v
c) Take two of the purple
leadwires and insert
each of the black jack
plugs into the sockets
at the top of the Elle
TENS 2 unit.
d) Now insert the pins
(at the other end of the
leadwires) into the
sockets attached to the
sticky electrodes.
Do not remove the
electrodes from the
backing at this stage.
If you wish, attach the easy-
release neck cord:
Setting up your Elle TENS 2
8
AA R6 1.5v
+
AA R6 1
ack Plug ack Plug
Pins
Sticky
Electrodes
Sockets
5v
+
AR6 1.5v
1
2
3
Pull all way
through
Pinch sides
to release
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Suggested electrode placement diagram
9
The sticky electrode pads need to be placed in the correct position for maximum
pain relief. It is preferable to obtain assistance from either your birthing partner or
medical adviser when positioning the pads.
Please read the following instructions carefully:
1. Clean the skin thoroughly and allow skin to dry before applying the pads.
2. Carefully peel the pads from the plastic backing using your forefinger and
thumb. Do not pull on the lead wires. Retain plastic backing and pouch for
storage after use.
3. Position the top two pads (connected to the left socket C 1) approximately
4cm either side of the spine and 4-5cm above the imaginary navel line as seen in
the diagram.
4. Position the bottom two pads (connected to the right socket C 2)
approximately 4cm either side of the spine and 4-5cm below
the imaginary navel line as seen in the diagram. Electrodes can be
used several times but the number of uses varies according
to the condition of the skin.
For general pain relief, see pad placement diagrams in the
'A Women's Guide to Drug Free Pain Relief' booklet.
Reference: Cluett E. (1994) SRN RM ADM PGCEA. Analgesia in Labour: A review of the TENS method. Professional Care of Mother and Child. Mar;4 (2): 50-2.
Bra line
C 1 C 1
C 2 C 2
Naval line
Panty line
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Turn your Elle TENS 2 on
Press the on/off button to power up the unit. The unit is in
BURST 1 mode.
Adjusting intensity for pain relief during labour
Begin by pressing the CH1+ key. Each time this key is pressed, ‘columns’ at the top
of the screen will appear on the screen increasing in number and size as the
intensity is increased. You will begin to feel a pulsating sensation.
Press CH1- and the columns will decrease in number should you wish to reduce
the intensity.
Repeat the previous step with the CH2+ and CH2- keys. You will now feel a
sensation in both sets of pads.
Press Display
Using the Elle TENS 2
CH1 CH2
BURST 1
5
50 10101515
150
CH1 CH2
BURST 1
55 010101515
150
CH1 CH2
BURST 1
55 010101515
150
10
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Using the Elle TENS 2
Display
CH1 CH2
BURST 1
5
50 10101515
150
CH1 CH2
55 010101515
205
030
BURST 1
Burst 1 (use between contractions*)
This is the first mode that you will use. It feels like a pulsing, tingling sensation
i.e. the pulses are off and on periodically. This mode will help to promote those
all-important natural pain-killing chemicals known as ‘endorphins’ and
‘encephalins’.
Boost 1 (use during contractions*)
When experiencing a contraction, simply press the Boost Button once and
release. This is the big button located at the top right of the unit. Your Elle TENS
2 will then switch automatically into the BOOST mode for that extra surge of
power required to combat pain during contractions. This will feel like a
continuous sensation. You do not need to hold the button in.
Once the contraction has passed, release the Boost Button by lightly pressing it.
The Elle TENS 2 will return to the original BURST 1 mode. Continue this cycle
during the early stages of labour.
*See page 13 for additional BURST and BOOST information.
11
CH1 CH2
55 010101515
BOOST 1
12
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Display
Using the contraction timer
The first time you press the Boost Button, the Elle TENS 2 will automatically
trigger the Contraction Timer (CT). This can be seen in the bottom right of the
display. This measures the duration of your contractions in seconds.
Once the contraction has passed and the Boost Button is released, the unit will
trigger the Between Contraction Timer (BCT) which measures the time between
contractions.
Recalling your contraction history
To recall a list of your last 5 ‘Contraction Times’ (CT) and ‘Between Contraction
Times’ (BCT) press the CH1- and CH2- buttons simultaneously.
The last recorded set of BCT and CT times are shown as 1.
Use CH2+ to go back to previous sets (eg, 2, 3, 4, 5) or forward again by pressing
CH2- key. Recalling the contraction history will not interrupt the functionality of
the unit.
N.B. To avoid losing contraction history, do NOT switch unit off.
Using the Elle TENS 2
12
Press
CH1 CH2
55 010101515
205
030
BURST 1
CH1 CH2
55 010101515
BOOST 1
12
78
144
1
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Display
To return back to the original mode screen, (which will have continued counting
the contraction times in the background) press the CH1- and CH2- buttons
together again.
The Mode Button
There are two mode ranges available on the Elle TENS 2, each with a Burst and
Boost function.
Mode 1 (BURST 1 and BOOST 1), which has been described above, is primarily
used for the earlier stages of labour.
Mode 2 (BURST 2 and BOOST 2) usually used when your labour advances and
your contractions become more frequent.
Press the Mode Button to switch between mode ranges. You will see from the User
Display, that the number on the centre right of the display will change from 1 to 2
(and vice-versa).
N.B. Both modes are interchangeable and can be used according to your
preference, not necessarily for the stage of labour you are in.
Using the Elle TENS 2
13
Press
Press
CH1 CH2
55 010101515
205
030
BURST 1
CH1 CH2
55 010101515
205
030
BURST 2
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Display
The Opti-Max Key
This provides extra versatility to your Elle TENS 2. Increasing or decreasing
the Opti-Max Key will allow you to either heighten or lessen the level of pulse
power transmitted to the electrode pads.
Pressing the Opti-Max Key either +or - will increase or decrease Opti-Max
sensation. This is extremely useful for the final stages of labour when you
need an extra surge of power. There are 5 Opti-Max levels: 50, 100, 150, 200 and
250애s (microseconds). The unit will always start up at Opti-Max 150애s,
which is exactly half way between the highest and lowest setting.
N.B. 1. The Opti-Max Key can be used according to your preference and not necessarily for
the stage of labour you are in. 2. When operating the Opti-Max Key the
CT information temporarily disappears, but reappears in 1 second automatically.
When you have finished
Press the On/Off Button to turn the unit off before removing the wires. Remove the
jack plugs from sockets holding the plugs between the forefinger and thumb. Remove
electrodes returning them to the plastic backing and pouch as supplied.
Using the Elle TENS 2
14
Press
CH1 CH2
55 010101515
BURST 1
250
Useful Tips
Continue stimulation for as
long as necessary, unless you
experience discomfort.
If you stimulate for a number
of hours ensure the pads do
not become dry. If this occurs,
switch off the unit, disconnect
the electrodes, and apply a
small drop of water to them.
Press
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15
Q When shall I start using my Elle TENS 2?
A Use as early as you can after the onset of labour to allow time for
your body’s pain-killing chemicals to rise.
Q Can I try the Elle TENS 2 before going into labour?
A Yes, using one leadwire, place 2 pads on your forearm to feel the
different pulse sensations following the instructions on page 10 for
C 1 and C 2.
Q Can I combine the Elle TENS 2 with other medication?
A Yes, you can still use analgesics such as gas and air (entinox)
or pethidine.
Q Can the Elle TENS 2 be used in hospital?
A Yes. owever, a midwife may ask you to switch it off temporarily.
Q Can I use the Elle TENS 2 if I am considering a water birth?
A Yes, but not in the water itself.
Q Is TENS safe?
A Yes, TENS is used widely for pain relief and is recommended
by medical professionals.
Q Can I use it with other medications?
A Yes. TENS is drug-free so you can use it with any
other medication including paracetamol.
Q What conditions can TENS be used to treat?
A TENS can be used to treat numerous pain conditions such as back
pain, neck pain, period pain and arthritic pain etc.
If you are unsure about using TENS please consult your medical
adviser or contact Babycare TENS at [e-mail].
Troubleshooting Questions
Q Why does the pulse sensation not appear to be as strong after
you have used the Elle TENS 2 for a while?
A Increase the intensity, you may have become acclimatised to
a lower setting.
Q Why does the pulse sensation feel strong but ineffective?
A You may need to reposition the electrode pads (don’t forget to
switch the Elle TENS 2 off before doing so).
Q What should I do if I can not feel any or little sensation even
on a high intensity setting?
A Check that the leadwires are properly connected and the pads are
fixed to the skin. Also check batteries.
Questions, answers and troubleshooting
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Specifications
Unit Size 115mm x 55mm x 30mm
Unit Weight 75 grams
Output Jacks CE Touch-proof jacks
Display Digital LCD - 8 seven segment digits and around
95 segments
Automatic Power Off Will switch off after 5 minutes if not used
Battery Low Detect 2.2v ± 0.2v
Battery 2 x 1.5v AA Battery (Type LR6)
Operating Environment
Temperature 0-40˚C
Air humidity 30-75%
Air pressure 700 hPa-1060 hPa
Storage and Transport
Environment
Temperature 0-40˚C
Air humidity 30-90%
Air pressure 700 hPa-1060 hPa
General
Programme Display Output Frequency / Duration
Burst Burst 1 Pulse Frequency (16 z) Pulse Width (150애s)
1 burst per second, 8 pulses per burst*
Burst Burst 2 Pulse Frequency (32 z) Pulse Width (150애s)
2 bursts per second, 8 pulses per burst*
Boost Boost 1 Pulse Frequency (80 z) Pulse Width (150애s)
continuous*
Boost 2 Boost 2 Pulse Frequency (100 z) Pulse Width (150애s)
continuous*
Output Channel Dual Channel
Output Waveform Symmetrical bi-phasic rectangular
Output Voltage 0 - 55v zero to peak adjustable in 15 steps at 500Ωload
Output Intensity 0 - 110mA adjustable in 15 steps at 500Ωload Intensity
level will drop back to zero after programme changes
Technical Specifications
Equipment type
Dual Channel Digital TENS
Classification
This unit is fully compliant with EEC Directive 93/42/EEC,
classified as internally powered equipment type BF.
It is intended for continuous operation.
* Default pulse width after mode changed (pulse width not changed when switched between BURST
and BOOST mode) 5 selectable pulse widths in all modes: 50, 100, 150, 200, 250
16
* Pulse width adjustment does not change when switching between Burst and Boost modes.
Default pulse width is 150애s. There are 5 adjustable pulse widths selectable in all modes: 50, 100, 150,
200 and 250애s.
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17
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 9),
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 a heart condition, epilepsy, undiagnosed pain, have any metal
implants, or any doubts whatsoever, consult your medical adviser.
6. Never use TENS to mask undiagnosed pain as this could require urgent treatment.
General Precautions & Adverse Reactions
1. Do NOT use this unit without first reading these instructions.
2. Do NOT immerse the Elle TENS 2 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 2.
6. Only use specified batteries and electrodes.
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 on varicose veins, 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. Do NOT use in the presence of tuberculosis, malignant tumors, very high or very low
blood pressure, high fever or acute inflammatory disease unless under medical
supervision.
15. Electrodes should only be applied to skin with normal sensation unless under medical
supervision as skin irritation may occur following long term application.
16. This is an internally powered medical electrical equipment. Do not use battery or
power sources other than those specified in these instructions.
17. 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 [phone].
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 2 is not user repairable and must be returned to the manufacturer if it
requires repair.
9. This unit needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the Accompanying
Electromagnetic Information document on page 19.
If you have any concerns please do not hesitate to contact Babycare TENS at
[e-mail].
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Checking system performance and troubleshooting
1. Check if the unit is turned on and if so, turn it off before taking any further steps.
2. Then replace the batteries and turn the device on. If it does not function at all, return
the device for repair.
3. If your unit does not appear to be operating properly or there are changes in the
performance of your equipment, first replace the batteries following the instructions
for doing so in this manual. Replacing the battery can eliminate most operational
problems. If the device still does not appear to function properly or the changes to the
performance still continue, turn off the unit and double check that your skin is
prepared as instructed above. Finally, replace your electrodes with new ones. If your
device still does not appear to function properly or the performance is still changed
return the device for repair to the manufacturer.
4. Where there are any unexpected operational issues or events when using this device,
turn off the unit and contact the manufacturer for advice and assistance.
Maintenance and Care (Guidelines for optimum performance):
1. Remove the batteries if this device is not likely to be used for some time.
2. Change the batteries regularly when regularly using this device.
3. The unit must be switched off when changing the batteries. Check if the unit is turned
on and if so, turn it off before taking any further steps.
4. The unit should be wiped clean periodically using a very slightly dampened cloth. A
mild soap may be used but DO NOT apply solvents.
5. Follow instructions supplied with your electrodes and take note of their intended
number of uses and replace them when needed.
6. Do not attempt to open or dismantle this device at any time to undertake any other
repairs or maintenance.
7. Please see troubleshooting section found on page 15 for further information.
Battery Replacement Please refer to page 7.
Materials The Elle TENS 2 casing is made from ABS plastic. Electrodes consist of
fibre, conductive carbon mesh and conductive hydro gel.
Applied Parts The self adhesive electrdoes and lead wires.
Device failures
1. Please do not attempt to repair damaged devices yourself.
2. In case of further inquiries, always state the model of your device (as this device
should only be repaired by the manufacturer’s qualified technical personnel).
3. This unit is guaranteed for a period of 2 years (the service life of this unit) against
manufacturer’s defects excluding consumables. Consumables include leadwires,
batteries and self-adhesive electrodes. The expected service life will depend on how
often the device is used but the average service life is expected to be 3 months for
leadwires, 20 hours for batteries and 10-20 applications for self-adhesive electrodes
depending on skin type.
4. Note: the guarantee is null and void if any attempt is made to open or modify the unit
by unauthorized personnel.
5. In the event of a fault please contact the supplier (address found on the invoice or
delivery note) or Body Clock, 108 George Lane, South Woodford, E18 1AD.
Tel: [phone] Fax: [phone] email: [e-mail]
Recycling Recycling of batteries, electrical and electronic equipment (WEEE)
When you decide to dispose of used batteries of if you ever choose to dispose of your
device, please do so safely using official recycling facilities. To find your nearest recycling
sites for waste electrical and electronic products, contact your local council, or visit
www.recycle-more.co.uk and type your postcode into the recycling bank locator.
Latex Warning
The Elle TENS 2 and applied parts are NOT made with latex. Please check carefully before
choosing to use any other third party accessories other than those provided by the
manufacturer.
Natural rubber latex or its synthetic derivative is used in numerous medical products.
Repeated exposure can result in sensitivity to natural rubber latex proteins, with
symptoms ranging from skin redness, rash, hives or itching to difficulty breathing and
wheezing. Rarely, shock and even death can occur. Learn to recognize the symptoms of a
natural rubber latex allergy, seek medical advice and take all steps recommended by your
medical advisors.
18
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Manufacture’s declarati n – electr magnetic emissi n
This unit is intended for use in the electromagnetic environment specified below.
The customer of the user of this unit should assure that it is used in such an environment.
Emissi n test C mpliance Electr magnetic
envir nment – guidance
RF emissions CISPR 11 Group 1
This unit uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF emission
CISPR 11
Class B
This unit is suitable for
use in all establishments
other than those directly
connected to the public
low-voltage power supply
network that in some
cases supplies buildings
used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
This pr duct needs special precauti ns regarding EMC and needs t be installed and put int service acc rding t the EMC inf rmati n
pr vided, and this unit can be affected by p rtable and m bile RF
c mmunicati ns equipment.
*Caution: This unit has been thoroughly tested and inspected to assure proper
performance and operation! This machine should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, this machine should be
observed to verify normal operation in the configuration in which it will be used
Manufacture’s declarati n – electr magnetic immunity
This unit is intended for use in the electromagnetic environment specified below.
The user of this unit should ensure that it is used in such an environment.
Immunity test IEC 60601 test level C mpliance
level
Electr magnetic
envir nment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact
±8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the relative humidity
should be at least
30%
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
not applicable
Not applicable
(For INTERNA Y
POWERED ME EQUIPMENT)
Surge
IEC 61000-4-5 ± 1 kV line(s) to line(s) not
applicable
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
5% UT (95% dip in
UT) for 0.5 cycle
40% UT (60% dip in
UTfor 5 cycles 70% UT
(30% dip in UT) for 25
cycles 5% UT (95% dip in UT) for 5 sec
not applicable
Conducted RF
IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
not applicable
Power frequency (50Hz/60Hz)
magnetic field IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic fields should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
EMC Inf rmati n f r the Elle TENS, Smart TENS and Elle TENS+
Manufacture’s declarati n – electr magnetic immunity
This unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this unit should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
C mpliance
level Electr magnetic envir nment - guidance
Conducte
d RF IEC
61000-4-6 Radiated
RF IEC
61000-4-3
3 Vrms 150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
not applicable
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of this unit, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter. Recommended separation distance:
not applicable
d=1.167 P 80 MHz to 800 MHz
d=2.333 P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, (a)
should be less than the compliance level in each
frequency range (b).
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not
apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a). Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which this unit is used exceeds the applicable RF compliance level above, this unit
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating this unit.
b). Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Rec mmended separati n distances between p rtable and m bile RF
c mmunicati ns equipment and this unit
This unit is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of this unit can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and this unit as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum utput
p wer f transmitter (W)
Separati n distance acc rding t frequency f
transmitter (m)
150 KHz to 80
MHz d=1.167 P
80 MHz to 800
MHz d=1.167 P
800 MHz to 2.5
MHz d=2.333 P
0.01
not applicable
0.117 0.233
0.1 0.369 0.738 1 1.167 2.333 10 3.689 7.379 100 11.667 23.333 For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies. NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
19
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0120
www.babycaretens.com
September 2017 (1)
This manual is recyclable
Body Clock Health Care Ltd
108 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 customercar[email protected]
Babycare TENS is part of the Body Clock group of companies
Guarantee
The Elle TENS 2 is guaranteed for 2 years against manufacturer’s
defects excluding consumables such as leads, electrodes
and batteries.
ElleTENS2In tructionManual2017_Layout 1 12/09/2017 17:00 Page 20