TensCare Perfect mamaTENS User manual

INSTRUCTIONS FOR USE
Perfect
READ INSTRUCTIONS CAREFULLY
BEFORE USE
T.E.N.S. Unit for Labour Pain Relief
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Perfect mamaTENS
1. Read instruction
book carefully
2. Check contents 3.
Press ON/OFF button to
check that the unit is
working (LCD will be
activated) then switch OFF
4. Attach leads to
the unit
5. Attach the electrodes
to your back and try
out the unit to see
how it feels
6. Replace electrodes
onto their liners and
seal them in the
re-sealable bag
7. Put everything back
into the pouch until
labour begins
8. As soon as labour
begins, set up, attach,
and use the unit as
per instructions
9. After the birth,
dispose of electrodes
and leads
10. Remove batteries Perfect mamaTENS
Helpline
Helpline
01372 723434
QUICKSTART GUIDE
11. Place unit, belt clip,
and neck cord back
into the pouch
Perfect
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Perfect mamaTENS
Contents Page
1 Introduction 1
2 What is TENS and how does it work? 1
3 Cautions and Warnings 3
4 What’s in the box? 5
4.1 Contents 5
4.2 Trial Run 5
5 Controls and Display 6
6 Assembly 9
6.1 Insert Batteries 9
6.2 Connect Lead Wires 10
6.3 Belt Clip and Neck Cord 11
7 Positioning of Pads 13
8 Using Your Perfect mamaTENS 14
8.1 Programme A 14
8.2 Programme B 15
8.3 Programme C 16
9 After Use 17
10 Cleaning 18
11 Battery Care 18
Low Battery Display 18
Warnings 18
12 Guarantee 19
13 Troubleshooting 20
14 Consumables and Servicing 21
15 Disposal of Waste Electrical and Electronic Products(WEEE) 22
16 TechnicalSpecications 23
17 EMC Precautions 25
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1. INTRODUCTION
The Perfect mamaTENS is a TENS machine specially designed to help
counter Labour Pain.
Thepainduringbirthmightstartwiththerstcontractionorwhenthecervix
starts to dilate. The pain then increases progressively until the cervix is
completely dilated. During this period you will experience pain of different
types and intensities but due to the innovative technology which has been
incorporated into your Perfect mamaTENS, you will be able to help counter
this. The Perfect mamaTENS achieves this by delivering a variety of signals
dependent upon the stage of your labour.
Pleasenotethatwhilstsomeexpectantmotherswillachievesufcient
pain relief using just the Perfect mamaTENS, others may require
additional pain relief. Perfect mamaTENS can be used with other pain
relief options such as gas and air but as you might expect should be
removed if having a water birth.
2. WHAT IS TENS AND HOW DOES IT WORK?
MidwivesrecommendmaternityTENSmachinesfortheirbenets,
particularly in early labour, as they enable mums to remain mobile and
upright. This aids descent and dilatation and provides a completely drug
free and natural form of pain relief which is safe for both you and your
baby. Maternity TENS machines can be used in conjunction with other
forms of pain relief.
However, as you might expect, it can’t be used in a birthing pool.
1
TENS stands for Transcutaneous
Electrical Nerve Stimulation.
Transcutaneous simply means
‘across the skin’.
We feel pain when signals reach the
brain from the affected area.
TENS works by stimulating the nerve
endings to reduce the pain message.
It also stimulates your body into
generating endorphins, the body’s
own natural pain relievers.
This is why pain relief can continue
even when the machine is switched off.
A very strong TENS signal produces
an additional pain blocking effect called
“Brief Intense TENS” for a short period
of time. We use this in the Programme
C Active Power ramp.
Your TensCare maternity TENS
machine allows you complete control
over the strength of the pain relief
it provides so that you can manage
your pain as labour progresses.
2
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3. CAUTIONS & WARNINGS
If you are in any doubt about any of these warnings please consult your
medical practitioner, midwife, or obstetric physiotherapist.
Do not use TENS :
•Ifyouhaveaheartpacemakerorhaveaheartrhythmproblem.
TENS in the direct vicinity of a pacemaker may affect some models. If
TENS is applied on the front of the neck this can affect your heart rate.
Very strong TENS across the chest may cause an extra heartbeat.
•Ifyouhaveepilepsy.
TENS may affect seizure threshold. You should consult your doctor
prior to using the mamaTENS unit.
•Duringtherstthreemonthsofpregnancy.
It is not known whether TENS may affect foetal development
•Ontheabdomeninthelaterstagesofpregnancy.
Stop use immediately if you experience unexpected contractions.
• Whendriving,operatingmachinery,orsimilaractionsneedingnecontrol.
Loose pads, damaged leads, or sudden changes in contact may cause
brief involuntary muscle movements
•Tomaskorrelieveundiagnosedpain.
TENS may delay diagnosis of progressive condition.
Caution:
• Observe caution when using the Perfect mamaTENS at the same time as
being connected to monitoring equipment with body worn electrode pads.
TENS WILL interfere with foetal ECG monitors, and may interfere with
other signals being monitored.
•Strongelectromagneticelds(electrosurgery/microwavecookers/
mobile phones) may affect the correct operation of this unit - See
section 21. If it appears to behave unusually, move it away from
these devices.
•Usecautionfollowingrecentsurgicalprocedures.
Stimulation may disrupt the healing process.
Do not place electrode pads:
•Onbrokenskin.
The pads could encourage infection.
•Onskinwhichdoesnothavenormalsensation.
If the skin is numb, too great a strength may be used, which could
result in skin inammation.
•Onthefrontoftheneck.
Could cause the airway to close, giving breathing problems. May cause
sudden drop in blood pressure (vasovagal response).
•Overtheeyes.
May affect eyesight or cause headaches
•Acrossthefrontofthehead.
Effect on patients who have had strokes or seizures is not known.
May affect sense of balance. The effects of stimulation of the brain
are unknown.
•Nearmalignanttumours.
In vitro experiments have shown that electricity can promote cell growth.
Do not:
•Ignoreanyallergicreactiontotheelectrodepads.
If a skin irritation develops stop using TENS, and try a different type
of electrode.
Also do not :
•ImmerseyourTENSunitinwaterorplaceitclosetoexcessiveheat.
It may cease to operate correctly.
•AttempttoopenuptheTENSunit.
This will invalidate the guarantee.
•Mixold,newordifferenttypesofbatteries.
•Usethisdevicewithleads,electrodes,andaccessoriesotherthan
those recommended by the manufacturer.
Performance may vary from specication.
3 4
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4. WHAT’S IN THE BOX?
When you open the box your Perfect mamaTENS is complete and ready
for you to use, with a carrying pouch that is ideal for putting into your
hospital bag.
4.1 CONTENTS
Insidethepouchyouwillnd:
•YourPerfect mamaTENS unit
•Asetofbatteries
•Neckcord
•Beltclip
•Electrodepadsdesignedspecically
for use with your Perfect mamaTENS
•Thisinstructionmanual
•Storagepouch
Before using your Perfect mamaTENS, please read this manual
thoroughly, especially the safety notes and precautions.
4.2 TRIAL RUN
!
WARNING
5. CONTROLS AND DISPLAY
5 6
We recommend that all mums-to-be familiarise themselves with the
unit prior to the due date for added peace of mind.
If you have any questions, contact Tenscare at www.mama-tens.info
Programme
Keypad
Lock Strength
UP
Strength
DOWN
OFF
Programme
Keypad
Lock
BOOST
Strength
Low Battery
ON
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The Perfect mamaTENS has six buttons on the front and one on the side.
The curved button to the left of the machine is
clearly marked ‘on’ and ‘off’ whilst the curved
green button to the right of the machine
is marked with arrows st to increase or
decrease the intensity as desired.
Press ON and hold for 3 seconds to turn ON
(This delay avoids turning ON accidentally).
A backlight comes on to help you see the display. This light will turn off 10
seconds after the last button press to save battery life.
The LCD display will appear as “A1 00” indicating that the unit has
automatically set itself into Labour Pain Phase A and Mode 1 at Zero
intensity (00). Press OFF to turn the unit off.
Pressandrelease▲buttontoincreasetheintensitybyonelevel.
Perfect mamaTENS has 50 levels of intensity in Programmes A & B and
60 levels in Programme C.
Pressandhold▲▼buttontochangeintensitycontinuously.
Pressandrelease▲▼buttontochangetheintensitybyonelevel.
As you increase the intensity you will experience a gentle tingling
feeling. You may feel little or no sensation from the Perfect mamaTENS
atitslowerlevels,butkeeppressingthe▲buttonuntilthesensation
is strong but comfortable. To maintain the effect as your body
becomes accustomed to the signal you will probably need to steadily
increasethestimulationbyraisingtheintensityalevelatatime:this
is perfectly normal.
SAFETY FEATURE - If the pads or leads become disconnected,
the intensity will automatically reset to zero.
If the Perfect mamaTENS is accidentally switched on it will switch
off automatically if the intensity is not pressed within 5 minutes.
In the centre of the panel are two
triangular buttons.
The top button ‘P’ is used to select from three
preset programmes, one for each stage
of labour.
The bottom button is marked . Holding
this button down for three seconds locks the
controls:thisavoidsanyaccidentalchanges
of intensity.
The▼buttonalwaysworks,evenwhenthe
lock is active.
Press again to unlock.
On the SIDE of the unit is a BOOST button. Its
action depends upon the programme selected
and is detailed within the section “Using your
Perfect mamaTENS”.
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.
NB
NOTE
7 8
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iii) Insert batteries
Ensure that the batteries are inserted the right way
as shown in the battery compartment and that the
ribbon is behind them.
iv) Replace battery cover and belt clip.
When the batteries are running low, a low battery
indicator will show on the screen and it is important to
change the batteries as soon as possible.
Rechargeable batteries
Do not use rechargeable batteries. They have a lower voltage and may activate
the low battery cut-out.
6.2 CONNECT LEAD WIRES
Insert the lead wire plugs into the base of the unit.
Insert the lead wire for the pads to be used under the bra line into Channel 1
at the base of the machine.
The lead wire for the pads which will be used on your lower back should
then be inserted into Channel 2.
OPEN CIRCUIT CUTOUT
If ALL FOUR pads of the Perfect mamaTENS are not correctly connected
to your body, the strength will automatically reset to zero. This is to
prevent sudden changes if a broken connection is re-made.
HINT: You can test your Perfect mamaTENS by connecting up the leads,
then moving the pads on the backing sheet so that the edges of the pads
just touch.
6 ASSEMBLY
Before use, you will rst need to assemble your Perfect mamaTENS.
6.1 INSERT BATTERIES
i) Remove belt clip by sliding down
ii) Remove battery cover by pressing
down the clip.
9 10
Channel 1
Channel 2
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Once you have done this you will need to ask your birthing partner to place
the electrode pads into the correct position on your back.
To ensure good adhesion of pads, the area of skin they are going to be
applied to needs to be clean, dry, and free from grease or powder.
Peel off the clear plastic covers and attach the pads to your back as shown
insection7.Pleasekeepthebagandclearlmlinersforpreservingthe
pads after use.
Place the pads which are wired to
Channel 1 under the bra line
and the pads wired to Channel 2 just
below the knicker line.
With the pads in place you can choose to use the belt clip or the neck cord,
whichever you are most comfortable with, so you are able to remain as
mobile as possible.
6.3 BELT CLIP and NECK CORD
A belt clip is provided to allow you to attach the Perfect
mamaTENS to your clothing. It can be inserted either
way up. Slide the clip along the base of the unit until it
locks in position.
11 12
CH1
CH2
You can also hang the unit from your neck with the neck cord using the
holes on each shoulder of the unit. The neck cord is designed to open for
safety if pulled - DO NOT USE OTHER CORDS.
Feed a loop of the neck cord through the hole in the shoulder of the unit and
pull through. Feed cord through the loop and pull tight towards the unit.
This neck cord is specially designed to pull apart if you snag it or the
machine. Do not use other things like string that might not break.
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7. POSITIONING OF PADS
The pads need to be placed over the junctions of the nerves joining the
womb and birth canal to the spinal cord. Correct positioning of the pads will
give maximum pain relief so please study the photograph and then follow
theseinstructions:
1. Carefully peel the pads off their plastic covers. Do not pull on the
lead wire.
2. Place the top pair of pads (connected to
CH1) either side of the spinal column 2 inches
(50mm) apart from each other and about
3 inches (75mm) below the bottom of the
shoulder blades (close to vertebrae T10, T11,
T12 and L1). This is just below the bra line.
3. The lower pair of pads (connected to CH2)
are placed either side of the spine about
4 inches (100mm) apart and about 1 inch
(25mm) above the dimples at the base of
the spine, just above the buttocks (close to
vertebrae S2, S3 and S4).
13 14
Upper
Pads
(Uterus)
Lower
Pads
(Perineum
& Birth
Canal)
!
A1
8 USING YOUR Perfect mamaTENS
You can start using Perfect mamaTENS as soon your contractions start to
become regular.
8.1 PROGRAMME A
When you switch the machine on it automatically
selects Labour Programme A.
The LCD screen will display ‘A1’.
This programme is designed to provide a pulsing
sensation that triggers the release of endorphins,
relaxing you and relieving you from pain.
There are two modes, A1 and A2.
Mode A1 is for use between contractions and mode A2 is for use during contractions.
You can switch between the two modes at any time by pressing the ‘Boost’ button.
The Perfect mamaTENS will start at zero intensity. Increase the intensity until you
feel a pulsing on-off-on-off sensation. Perfect mamaTENS has 50 small steps of
intensity,soyouhavenecontrolofthestrengthofstimulation.
When the next contraction starts press the ‘Boost’ button once and the mode
will change to mode A2, at the same intensity level as it was when in mode
A1. Mode A2 feels like a constant strong tingling.
At the end of the contraction, press the ‘Boost’ button to return to mode A1.
Repeat this each time a contraction starts.
As the contractions become stronger simply increase the intensity.
If a lead wire becomes detached from its socket the unit will
automatically reset intensity to zero.
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NB
NOTE
15 16
HOLD RELEASE
STRENGTH
8.2 PROGRAMME B
You should stay in programme A as long
as possible, but when your contractions
intensify and become more frequent you
can progress to programme B.
Do this by pressing the programme button.
The LCD screen will display ‘B1’.
To avoid discomfort with the change in
programme, the set intensity will drop
by half. Press and release the
INTENSITY▲BUTTONuntilyoureachacomfortableintensitysetting.
Again there are two modes.
The second mode is triggered by pressing the boost button when you
experience a strong contraction. This mode provides a constant tingling
sensation.
When the contraction passes press the boost button once more and your
Perfect mamaTENS unit will change back to mode B1.
Programme B provides you with a stimulation pattern which is set to block
the heightened pain which you may suffer.
You will feel that the stimulation in the higher set of pads (which have
been placed just below your bra line) is stronger than the lower set
ofpads(atthebottomofyourback):thisisintentionalandpartofthe
therapy.
As the contractions become more intense and closer together, increase
the intensity.
If the lower electrodes feel stronger than the upper ones then the leads
have probably been incorrectly inserted into the Perfect mamaTENS.
To correct this, change over the leads, and reset the intensity.
8.3 PROGRAMME C
IfyoundprogrammesAandBdonotmeetyourneedsforpainreliefthereisa
third programme C, which provides a higher level of pain relief.
Press the programme button again and this will take you to programme C
which will be displayed on the screen as ‘C’.
To avoid discomfort with the change in programme, the set intensity
will drop by half. Pressandreleasethe▲buttonuntilyoureacha
comfortable intensity setting.
Again there are two modes.
However this time mode C is continuous. Pressing the BOOST button
starts the Active Power mode which ramps the power or level of intensity
duringthenalcontractionstogivetheadditional“Briefintense”
pain relief.
In between contractions use the INTENSITY ▲&▼BUTTONSuntil you
reach a comfortable level.
When you experience a contraction just press the BOOST button down
and HOLD IT.
The intensity will increase until you release the BOOST button because the
intensity became too much to bear.
When you release, the intensity will drop rapidly and return to the background
setting you pre-selected.
As it falls, you can press and hold the BOOST button again to keep the
intensityataxedleveltotheendofyourcontraction.
In MODE C the Intensity goes up to 60
This is a very natural way for you to control your pain as you rapidly increase
and decrease the intensity to match the strength of your contractions.
NBPowerRamp:isshownonthescreenas‘CAP’(ActivePower).
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When instructed to start ‘pushing’ you can use the Prog button to switch
the TENS unit back to programme A.
And that’s all there is to it. It’s quite simple really.
Just remember the three programmes A, B and C which you can choose
at any time as your labour progresses, and when you need a boost, just
press the ‘BOOST’.
9. AFTER USE
Always ensure that the Perfect mamaTENS
is switched OFF before removing
the electrodes.
After use, return the electrodes onto the clear
plastic covers and store in the resealable
bag(s). The electrodes are water-based, and
will dry out if left out in the open.
After the birth, you can use your Perfect mamaTENS to help with post-
episiotomy pain.
•Ifyouarere-usingtheunit,besuretoreplacepadswhentheylosetheir
stickiness. Poor connection may cause discomfort and skin irritation.
If you purchased, rather than rented, and plan to put your Perfect
mamaTENSintostorageforyournextbabythendothefollowing:
•Cleanasinstructed
•Removebatteries
•Throwawaytheelectrodepadsandleads
(You will need to buy a new set for the next use).
•Storagelifeofanunopenedpackofelectrodesis2years.Thismaybe
affected by very high temperatures or very low humidity.
17 18
!
WARNING
10. CLEANING
Clean the case and lead wires after each use by wiping with a damp cloth
and a solution of mild soap and water. Wipe dry.
Do not immerse your TENS machine in water.
Do not use any other cleaning solution than soap and water.
11. BATTERY CARE
LOW BATTERY DISPLAY
If the batteries begin to lose their power a battery symbol will appear
on the LCD. Change both batteries at this stage using spare batteries
supplied. See instructions below as to how to change the batteries.
Warnings
•ThePerfectmamaTENSwillnotfunctionifthebatteriesare
inserted incorrectly and damage to the unit could occur.
•ReplaceonlywiththeAA(LR6)batterytypeindicated
•Replacebothbatteriesatthesametime.
•Donotdisposeofthebatteriesinare.
•Keepbatteriesoutofthereachofchildren.
•Donotattempttorechargealkalinebatteries
•Ifbatteryleakageoccursandcomesincontactwiththeskinor
eyes, wash thoroughly with plenty of water.
Storage
•RemovebatteriesfromyourTENSmachineiftheunitisunlikely
to be used for a long period. Some types of battery may leak
corrosiveuid.
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19 20
Problem Possible causes Solution
No display Flat batteries Replace batteries
Batteries inserted Check
incorrectly
Damaged battery Contact supplier
contacts
Low battery Low batteries Replace batteries
display
No Incorrect Have you applied both electrode pads (per
sensation connection lead wire) to ensure a complete circuit?
Not strong enough Increase strength.
Most users will feel something at a
setting below 10
Intensity Open circuit cutout Ensure machine is attached to your
will not go body correctly.
above zero
Lead faulty/damaged Purchase replacement if necessary.
Disposal of batteries
•Alwaysdisposeofbatteriessafely.
•Donotthrowbatteriesontoare.Riskofexplosion.
Battery Life
•Batteriesshouldlastabout48hoursatfullpower.
•Unusedbatterieshaveanominalshelflifeof3years,butwill
usually last longer than this.
12. GUARANTEE
Your unit is guaranteed for two years from the date of purchase.
If a fault develops, return the unit to Perfect mamaTENS at the address
on the back cover, together with a copy of your invoice and details of the
problem. The guarantee does not cover the batteries, electrode pads or
mono leadwire.
PleasenotethattheGuaranteeisinvalidatedif:-
i)incorrectbatterieshavebeentted.
ii) the unit has been immersed in water, maltreated or tampered with.
iii) the unit has not been used with genuine Perfect mamaTENS or
Tenscare electrode pads.
13. TROUBLESHOOTING
IfyourTENSmachineisnotworkingproperlypleasecheckthefollowing:
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 or by phoning
01372 723 434.
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21 22
14. CONSUMABLES AND SERVICING
Replacement electrode pads and batteries are available from your
supplier or distributor (see back cover for contact details), by mail order
from TensCare, by telephone using a credit or debit card, or through the
TensCare website.
The following replacement parts may be ordered from TensCare at
www.tenscare.co.uk or by calling [phone]
E-CM50100-PM Pack of 4, 50 x 100mm electrode pads
B-AA 1.5V AA batteries
X- BC-PT Replacement belt clipX- BL-PTT Replacement battery cover
To ensure reliability and hygiene, use only genuine rectangular electrodes
withintegralleads:-
These are available either from your supplier or by contacting on 01372
723434 or by going to www.tenscare.co.uk. Please ensure that you order
the correct pads.
Batteries can also be purchased in the same way or on the high street
They are AA 1.5v alkaline batteries.
There are no user serviceable parts and no calibration is required.
Circuit diagrams and performance checking information are available from
TensCare on request.
Forservicingpleasereturntheunitto:YourSupplierorTensCareLtd,9
Blenheim Road, Longmead Business Park, Epsom, Surrey KT19 9BE.
Please ensure that you enclose your name, address and contact telephone
number so that you can be contacted and informed about any problem and
any costs involved.
Expected Service Life
•Themachinewilloftenlastformorethan5years,butisguaranteedfor
2 years. Accessories (leads, pads, and batteries) are not covered by
the guarantee.
•Leadlifedependsgreatlyonuse.Alwayshandletheleadswithcare
• Pads should last 12-20 applications, depending on skin condition
and humidity.
•AAAlkalineBatteriesshouldlastabout48hourscontinuoususe.
Storage life
•Storagelifeofanunopenedpackofself-adhesiveelectrodesis2years.This
may be affected by very high temperatures or very low humidity.
•Storagelifeofbatteriesis3years.
•Theunithasnoxedshelflife.
15. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC
PRODUCTS (WEEE)
One of the provisions of the European Directive 2002/96/CE is that anything
electrical or electronic should not be treated as domestic waste and simply
thrown away. To remind you of this Directive all affected products are now being
marked with a crossed-out wheelie bin symbol, as depicted below. To comply
with the Directive you can return your old electro-therapy unit to us for disposal.
Simply print a postage-paid PACKETPOST RETURNS label from our
website www.tenscare.co.uk, attach this to an envelope or padded
bag with the unit enclosed, and post it back to us. Upon receipt
we will send your old device for components recovery and
recycling to help to conserve the world’s resources and minimise
any adverse effects on the environment.
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Waveform Symmetrical Bi-Phasic Rectangular
Amplitude 70 mA zero to peak
(over 500 Ohm) 50 steps in A&B, 60 steps in C
Channels Dual channel
Weight 75 grams w/o batteries
Dimensions 120 x 60 x 20 mm w/o clip
Batteries 2 x 1.5V AA Alkaline LR6
Display LCD with backlight
 Environmental: Temperaturerange:5to40C
 Specications Humidity:15to93%RHnon-condensing
 Operating Temperaturerange:-25-+70CRH93%noncondensing
Storage
ContactDuration: atleast10minutes
 Safetyclassication Internalpowersource.
Designed for continuous use.
No special moisture protection
TYPE BF Equipment providing a degree of protection against
EQUIPMENT electric shock, with isolated applied part.
This symbol on the unit means “Refer to
Instructions for Use”
The unit is not water resistant, and should be protected
from liquids.
IP22 Complies with EU WEEE regulations
NBTheelectricalspecicationsarenominalandsubjecttovariationfromthelistedvaluesdueto
normal production tolerances.
23 24
16. TECHNICAL INFORMATION Symbols Used
Attention! Please follow the instructions in the User Manual.
TYPEBFEQUIPMENT: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 Instruction Manual”.
TemperatureLimitation:indicatesthetemperaturelimitstowhichthe
medical device can be safety exposed.
LotNumber:indicatesthemanufacturer’sbatchcodesothatthebatchor
lotcanbeidentied.
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
specicmedicaldevicecanbeidentied.
Do not dispose in household waste.
CatalogueNumber:indicatesthemanufacturer’scataloguenumberso
thatthedevicecanbeidentied.
This medical device is not water resistant and should be protected
from liquids.
AtmosphericPressure:indicatestheatmosphericlimitstowhichthe
medical device can be safely exposed.
DateofManufacture:indicatesthedatewhichthemedicaldevicewas
manufactured. This is included within the serial number found on the
device (usually in the battery compartment), either as
“E/Year/Number” (YY/123456) or
“E/Month/Year/Number” (MM/YY/123456).
This medical device is indicated for home use.
LOT
S/N
REF
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25 26
IP22 The rst number 2: Protected against access to hazardous parts
withanger,andthejointedtestngerof12mmø,80mmlength,
shall have adequate clearance from hazardous parts, and protected
againstsolidforeignobjectsof12.5mmø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.
Programme Settings
Display Mode Frequency/Pulse Width
A1 Burst 80Hz 150us
A2 Boost Continuous 80Hz 150us
B1 Burst 150Hz 150us
B2 Boost Continuous 150Hz 150us
C Ramp 80Hz 250us
17. EMC PRECAUTIONS
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).
Full guidance tables are available from TensCare on request
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 organization
to use the CE 0473 marking on this product
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TensCare Ltd, 9 Blenheim Road,
Epsom, Surrey KT19 9BE, UK
Tel:+44(0)1372723434
www.tenscare.co.uk
Distributedby:
PubRef.:I-PM-UKRev1.003/16
Manufacturedby:
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