Revitive RLV User manual

PLEASE READ THE USER’S
MANUAL CAREFULLY BEFORE
USING THIS PRODUCT
USE ONLY AS DIRECTED
IF SYMPTOMS PERSIST, CONSULT
YOUR HEALTHCARE PROFESSIONAL
Model number: RLV
User’s Manual (EN)
®
®
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23
What is inside the box? 4
Parts and Controls 5
Introduction to REVITIVE 6
Indications for use 6
How REVITIVE works 7
Important Safeguards 8-11
Contraindications 8
Warnings 9
Cautions 10
Safety Precautions 10-11
Adverse Reactions 11
Instructions for use 12
How long should I use REVITIVE? 12
Step 1: Setting up REVITIVE for the first time 12
Step 2: Using the foot-pads 13-15
Step 3: Using the Body Pads 16-21
Step 4: Cleaning and storing 21
Troubleshooting 22-23
Technical Specifications 24-25
Warranty 26
Table of contents - REVITIVE DX
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45
A
B
What is inside the box?
Upon opening the carton, please check that the following components
are provided. If you think anything is missing, please contact us using the
helpline numbers on the back of this booklet.
H
I
G
E
I
F
H
Control panel/display
Power ON/OFF
Foot-pads
Power adaptor socket
Body Pad socket
Intensity control – /+
Power adaptor
REVITIVE DX DBody Pad cord
Controls of REVITIVE DX
Control panel
Parts and Controls of REVITIVE DX
Parts of REVITIVE DX
Time
remaining
Intensity
Level
Electrode Body Pads
C
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67
Introduction to REVITIVE
INDICATIONS FOR USE
REVITIVE is intended to:
• Reduce pain and discomfort in the legs/ankles/feet - caused by
diabetic peripheral neuropathy or swelling (oedema) due to
osteoarthritis or following surgery
• Reduce swelling in the legs/ankles/feet - caused by being
immobile due to osteoarthritis or an injury
• Improve circulation to reduce or prevent blood-pooling (stasis) - caused
by diabetes or by being immobile following surgery
• Help maintain leg vein health - by increasing circulation, delivering
more oxygenated-blood and reducing swelling (oedema) in the legs,
feet & ankles.
The above Indications for Use are certified under the Medical Devices
Directive 93/42/EEC
In addition, if you have a sedentary lifestyle or spend long periods inactive,
REVITIVE may help to:
• Reduce discomfort in legs & feet
• Reduce swollen feet & ankles
• Alleviate cramp
• Actively improve circulation
HOW REVITIVE WORKS
REVITIVE delivers Electrical Muscle Stimulation (EMS) to your feet via a pair
of cushioned foot-pads, while you are seated. The electrical stimulation
causes muscles in your calf and foot to contract, which helps to increase
circulation in your legs.
REVITIVE has been developed so that it is comfortable for you to use.
REVITIVE can also deliver electrical stimulation to the knees, shoulders,
back or arms through the use of the Electrode Body Pads provided.
Visit www.revitive.com for more information
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89
IMPORTANT SAFEGUARDS
Warnings
•Consult with your doctor before using this device if:
• You are in the care of a doctor
• You have a history of heart problems
• You have suspected or diagnosed epilepsy
• You are unsure about the suitability of REVITIVE for you
• You are unsure about the cause of your symptoms
•If you have a metallic implant, you may experience pain or discomfort near
the implant when applying electrical stimulation, if this should occur
discontinue use and seek advice from your doctor
•The electrical stimulation may feel more intense close to a metallic implant.
It is safe to continue use provided no pain is experienced. You may need to
adjust the intensity to a comfortable level
•Do not use the Electrode Body Pads on your head, face, neck or chest.
•Do not apply foot-pads or Body Pads directly:
•on open wounds or rashes, swollen, red, infected, or inflamed
areas or skin eruptions (such as phlebitis, thrombophlebitis,
varicose veins, cellulitis)
•on or close to, malignant tumours
•on areas treated with radiotherapy (within the past 6 months)
•on reproductive organs
•Electrode Body Pads are for single person use only. Do not share body
pads with others
•Do not use Electrode Body Pads after their use by date.
•There is a chance you may experience skin irritation or burns beneath
the stimulation electrodes or hypersensitivity due to the electrical
stimulation.
• Symptoms may worsen during the initial treatment phase before
getting better. This may occur if the body has not yet adjusted to
increased muscular activity and blood circulation. If this occurs, reduce
the intensity and the duration of treatment which will reduce the initial
symptoms. If symptoms persist consult with your doctor
READ ALL INSTRUCTIONS BEFORE USE
WHO SHOULD NOT USE REVITIVE
REVITIVE should not be used by some people.
Do not use if (contraindications):
• You are fitted with an electronic implanted device such as a heart
pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD)
• You are pregnant
• You are being treated for, or have the symptoms of, an existing Deep
Vein Thrombosis (“DVT”)
Long periods of inactivity can put you at greater risk of developing Deep
Vein Thrombosis (DVT). DVT is a blood clot and usually occurs in a deep
leg vein. If part of the DVT breaks off it may lead to potentially life-
threatening complications such as pulmonary embolism.
If you have been inactive for prolonged periods and suspect you may
have a DVT, consult your doctor immediately. To prevent dislodging the
clot do not use REVITIVE.
In some cases of DVT there may be no symptoms. However it is important
to be aware of the symptoms that may include:
•pain, swelling and tenderness in one of your legs (usually your calf)
•a heavy ache in the affected area
•warm skin in the area of the clot
•redness of your skin, particularly at the back of your leg, below
the knee
Consult your doctor as soon as possible if you show any signs of the
above symptoms.
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10 11
IMPORTANT SAFEGUARDS
• Ensure that balm/gel/moisturiser is evenly applied and thoroughly
absorbed into the skin before applying stimulation. There is a chance
that uneven application of a balm/gel/moisturiser could increase the
risk of skin irritation or burn, when using the electrical stimulation
Cautions
•Be careful when applying stimulation:
•Over areas of skin that lack normal sensation. It may cause skin
irritation due to the inability to feel stimulation until the intensity is
too high - use a low intensity to achieve a gentle muscle
contraction, and/or use for a shorter time, to avoid overstimulation.
Check for signs of skin irritation (redness), bruising or pain. If in
doubt consult your doctor
•Over the abdomen during menstruation
•After recent surgical procedures as stimulation may disrupt your
healing process
•If you are likely to bleed internally, such as following an injury or
fracture – use a low intensity and/or shorter time to avoid over-
stimulation
•After a long period of immobility or inactivity – use a low intensity
and shorter time to avoid overstimulation or muscle fatigue
•This product is not intended for use by persons with reduced physical,
sensory or mental capabilities, unless they are supervised by a person
responsible for their safety
Safety Precautions
•Do not stand on the machine. Use only when sitting down
•Use the device only for its intended purpose
•Do not expose the device to extreme heat
•Do not spill liquid on the device or its accessories
•Do not overload the electrical socket
•Keep this device out of the reach of children
•REVITIVE may be used by multiple persons, ensure device is cleaned
after each use
•Use REVITIVE only with the accessories supplied by, or purchased from,
the manufacturer
•Check Body Pads, cords and cables periodically for damage
•Do not open REVITIVE or repair it yourself. This will invalidate your
warranty and may cause serious harm
•In the unlikely event your REVITIVE malfunctions, disconnect it from the
power source and contact your nearest authorised agent
•REVITIVE has passed the required tests for Electromagnetic
Interference (EMI); it may still be affected by excessive emissions and/
or may interfere with more sensitive equipment
•After any exposure to hot or cold temperatures outside the specified
operating range of 10 – 40°C allow the product to re-adjust to the
recommended operating temperatures to ensure continued product
performance
Adverse Reactions
•If you experience adverse reactions, stop using REVITIVE and
consult with your doctor
SAVE THESE INSTRUCTIONS
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12 13
Instructions for use
STEP 1:
SETTING UP REVITIVE FOR THE FIRST TIME
aRemove all parts from the carton:
•
Power adaptor
• REVITIVE DX device
• Body Pads
• Body Pad cord
See What is inside the Box? on pages 4-5 to help identify the parts
How long should I use REVITIVE for?
It is recommended to use REVITIVE for 20-30 minutes
per day.
Do not use REVITIVE more than 6 sessions of 30 minutes
(or the equivalent) per day. This may result in muscle
fatigue.
bLocate the power adaptor.
cPlug the small end of the power cord into the
opening on the side of the REVITIVE.
dPlug the power adaptor into the nearest
electrical socket.
R
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STEP 2:
USING THE FOOT-PADS
a Get into a comfortable seated position.
For best results sit with your knees at a 90 degree angle
(right angle).
b Place REVITIVE on the floor in front of you.
REVITIVE is designed to be used while seated.
Never stand on the REVITIVE unit.
c Place both bare feet on the foot-pads.
Make sure you remove all footwear, including socks/
stockings.
d If desired, apply a moisturising lotion to the soles of
your feet.
Hint: Applying a moisturising lotion to the soles of the
feet before using REVITIVE can help improve the
delivery of electrical stimulation.
ePress the power button on the REVITIVE.
You will hear a beep and the display lights will read
30 minutes.
To turn off the device at any time during
operation, press the power button.
Sit with
both bare feet
on the foot-pads
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14 15
fPress the (+) Intensity Control one time to
start stimulation.
Press the (+) button to increase the level.
Press the (–) button to decrease the level.
gEnsure you familiarise yourself with the feeling of
Electrical Muscle Stimulation (EMS). Use on a low
intensity for 20-30 minutes once per day for a few days.
Set the intensity at a level you can feel the stimulation in
your feet and/or calf muscles, or see your muscles twitch.
It is normal to feel tingling or varying sensations in your
calf muscles.
REVITIVE does not vibrate.
hAfter a few days of familiarisation, use a higher intensity
that provides you with strong but comfortable muscle
contractions.
You can set the intensity between 1-50.
Please note that the intensity required may vary from
day to day - eg using it on 25 one day, does not
necessarily mean you will need to use if at 25 the
next day. The required intensity could be higher or
lower than previous usage.
Instructions for use
If you feel pain or discomfort:
• Remove one or both feet from the foot-pads to
stop the stimulation.
• Lower the intensity of the foot-pads using the
(–) Intensity level button on the control panel
before replacing your feet on REVITIVE.
iWhen you have finished setting the intensity, the display
reverts to the Minutes-counter, counting down the
session time, from 30 minutes.
Each time you adjust the intensity, the intensity level
shows in the display. Again, when you have finished
adjusting the intensity, the display reverts to the
Minutes-counter, continuing to count down the
session.
jWhen REVITIVE times out, the time display
reads (00) and you will hear three beeps.
k The REVITIVE switches itself off automatically.
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16 17
R
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STEP 2:
USING THE BODY PADS
REVITIVE comes with one pair of reusable (up to 20-30 applications)
Electrode Body Pads that can be used to deliver electrical stimulation to
the back, shoulders, thighs, knees or arms.
a Select the area you wish to apply electrical stimulation to.
Example Body Pad placements are shown below:
Do NOT use the Body Pads on your head, face, neck or chest.
Instructions for use
Thigh Knee
Back of
Shoulder
Upper Back
Lower Back
✔
✔
✔
✔
✔
✔
b Clean and dry the area where you will place the Body
Pads.
c Make sure REVITIVE is switched off. If the control panel
is still illuminated, press the power button and turn
REVITIVE off.
d Attach the ends of the Body Pads to the Body Pad
Cords.
Press connectors until no gap is between them.
Leaving a gap may cause discomfort.
ePlug the other end of the Body Pad cord into the
opening on the side of REVITIVE
Plugging in the Body Pad cord will automatically
turn the foot-pads off.
fRemove the plastic liner from the Body Pads, by
peeling it off carefully. Replace the Body Pads onto the
plastic liner after use.
gPress the Body Pads on the area(s) you wish to apply
electrical stimulation, as shown on page 16, gently
pressing the adhesive side against the skin.
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18 19
hPress the power button on the REVITIVE.
You will hear a beep and the display lights will read
30 minutes.
To turn off the device at any time during
operation, press the power button.
iPress the (+) Intensity Control, one time, to
start stimulation.
Press the (+) button to increase the level.
Press the (–) button to decrease the level.
jEnsure you familiarise yourself with the feeling of
Electrical Muscle Stimulation (EMS). Use on a low
intensity for 20-30 minutes once per day for a
few days.
Set the intensity at a level you can feel the stimulation
or see your muscles twitch.
It is normal to feel tingling or varying sensations in
the muscles you are treating.
k After a few days of familiarisation, use a higher
intensity that provides you with strong but
comfortable muscle contractions.
You can set the intensity between 1-50.
Please note that the intensity required may vary from
day to day - eg using it on 25 one day, does not
necessarily mean you will need to use if at 25 the
next day. The required intensity could be higher or
lower than previous usage.
Instructions for use
R
R
R
R
If you feel pain or discomfort - lower the intensity of
the Body Pads using either the (–) Intensity Control on
the control panel of the device or on the remote control
lWhen you have finished setting the intensity, the
display reverts to the Minutes-counter, counting
down the session time, from 30 minutes.
Each time you adjust the intensity, the intensity level
shows in the display. Again, when you have finished
adjusting the intensity, the display reverts to the
Minutes-counter, continuing to count down the session.
mWhen REVITIVE times out, the time display reads
(00) and you will hear three beeps.
n The REVITIVE switches itself off automatically.
o Ensuring that the device has switched itself off, then
gently peel the Body Pads from the skin.
Do not pull the Body Pads off the skin using the
Body Pad cords as this may damage the cords.
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20 21
Instructions for use
STEP 4:
CLEANING AND STORING REVITIVE
aPress the power button and turn REVITIVE off, if needed.
bWipe down the foot-pads with a soft damp cloth.
Do not clean with chemicals.
Do not immerse REVITIVE in water.
cStore REVITIVE in a cool, dry and dust-free location.
Store out of direct sunlight.
dStore the Body Pads in a dry and ventilated location.
Store out of direct sunlight.
You do not have to detach the Body Pads from the Body Pad cords to
store them.
pReplace the Body Pads onto the plastic liner after use.
qUnplug the Body Pad cord from the device.
You do not need to detach the Body Pads from the
Body Pad cords.
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REPLACING THE ELECTRODE BODY PADS
The Body Pads are reusable up to 20-30 applications. If the Body Pads
start to lose their adhesiveness, rub a few drops of water into the surface.
Replacement Electrode Body Pads can be obtained from www.revitive.com
Important: the foot-pads will not produce a stimulation if the Electrode
Body Pads are plugged in.
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22 23
Problem Possible Cause Solution
No power or lights to
REVITIVE when it is
switched on.
Power adaptor not switched on
at the electrical socket or power
adaptor not plugged into device
properly.
Check electrical socket power
is switched on and the power
adaptor is plugged into
the device correctly. If still
not working – contact your
authorised dealer.
REVITIVE is not
vibrating.
REVITIVE IS NOT DESIGNED TO
VIBRATE.
My legs are aching
after treatment.
You may have the intensity
on too high a setting and your
muscles are being overworked.
Leave adequate time after
each treatment to allow the
muscles to recover (just like after
vigorous exercise!). On your
next session start on a lower
setting (where you can feel the
mild electrical stimulation and it
is comfortable) and reduce the
duration until your muscles have
acclimatized to the stimulation.
Troubleshooting
For more information including Frequently Asked Questions,
please visit www.revitive.com
Problem Possible Cause Solution
REVITIVE is on (lights
illuminated on the
LED display) but
I cannot feel the
electrical stimulation
through the foot-
pads.
Not placing both bare feet on the
foot-pads at the same time.
Ensure that your feet are bare
and each foot is placed on each
of the foot-pads at the same
time. Keep increasing the
intensity up to a maximum of 50
until you feel the stimulation.
Your feet may be dry. Moisturise the soles of your feet
to improve conductivity and
stimulation and try the procedure
again. You may also have to
increase the intensity level.
You may be dehydrated. Drink plenty of water before
and after using the device. The
device uses your body to create
the electrical circuit. Water is an
excellent conductor of electricity
and if your body is less hydrated
(below 60%) then the stimulation
may be less. Therefore it is
important to always remain well
hydrated.
The intensity level may be on
too low a setting. This is a very safe device. Keep
increasing the intensity
level towards 50 until you feel
the stimulation. You may find
that you have to increase the
intensity level as you get used to
the therapy. The aim is not to get
to 50 but to find a setting that is
comfortable for you.
Body Pad cord is connected to
device. Disconnect the Body Pad cord -
the foot-pads will not work while
the Body Pad cord is plugged in.
If, having tried the solutions
above, you still cannot feel the
stimulation:
Test the device by placing one
hand across both footpads at the
same time (The heel end of the
footpads is easiest). With your
other hand, and starting from
zero, increase the intensity
level until you can feel the
stimulation. If you can feel the
stimulation through your hand
then the device is working. If
on 50 you still cannot feel the
stimulation then please contact
your authorised dealer.
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24 25
Technical Specifications
Complies with European Medical Devices Directive (93/42/EEC)
The Waste Electrical and Electronic Equipment Directive
(WEEE Directive).
At the end of the product lifecycle, do not throw this product
into normal household garbage, but take it to a collection point
for the recycling of electronic equipment
Legal manufacturer of the device
Keep dry
Consult instructions for use
Device LOT and serial number including year (YYYY) and month
(MM) of manufacture can be found on the box and back of unit
Humidity and temperature limit for storage
Indoor Use Only
Do not disassemble
Item number
Date of manufacture
Use-by date
10°C 30%
40°C
90%
#YYYYMMXXXXX
LOT
REF
Name of product REVITIVE DX
Model RLV
Frequency 1Hz – 50Hz
Output current Max 8.5mA
Weight 1.13kg
Dimensions Ø 355 mm x 77(D) mm
Power consumption 5W
Power adaptor CE Approved
Power source
Input (adaptor used)
Output
100-240V AC ( ), 50/60Hz, 0.18A
5V ( ) DC ,1.0A
Contraindications
This describes situations where you should not use REVITIVE
Warnings and cautions
Make sure you understand these before using REVITIVE
Power
Time Remaining
Intensity Level
Center Positive Polarity
Type BF medical electrical equipment
Class II medical electrical equipment double insulated
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26 27
Your international two year warranty
It is important to retain the retailer’s receipt as
proof of purchase. Staple your receipt to this
back cover for future reference.
Please quote the following information if the
product develops a fault. These numbers can
be found on the base of the product:
Model no: ............................................................
Lot no: .................................................................
All REVITIVE devices are individually tested
before leaving the factory. In the unlikely event
of any device proving to be faulty within 30 days
of purchase, it should be returned to the place
of purchase for it to be replaced.
If the fault develops after 30 days and within 24
months of original purchase, you should contact
your local distributor quoting model number
and LOT number on the product, or write to
your local distributor at the address shown.
You will be asked to return the product (in
secure, adequate packaging) to the address
shown with a copy of proof of purchase.
Subject to the exclusions set out below (see
Exclusions) the faulty device will then be
repaired or replaced and dispatched, usually
within 14 working days of receipt.
If, for any reason, this item is replaced during
the 2 year guarantee period, the guarantee on
the new item will be calculated from the original
purchase date. Therefore, it is vital to retain
your original till receipt or invoice to indicate the
date of initial purchase.
To qualify for the 2 year guarantee, the
device must have been used according to the
manufacturer’s instructions supplied.
EXCLUSIONS:
1Actegy Ltd, manufacturer of REVITIVE
devices, shall not be liable to replace the
goods under the terms of the guarantee
where:
•The fault has been caused or is
attributable to accidental use, misuse,
negligent use or used contrary to the
manufacturer’s recommendations or
where the fault has been caused by
power surges or damage caused in
transit.
•The device has been used on a voltage
supply other than that stated on the
product or used with a power adaptor
other than the one supplied with the
product.
•Repairs have been attempted by persons
other than our service staff (or authorised
dealer).
•The device has been used for hire
purposes or non-domestic use.
•The device is second hand.
2 Actegy Ltd are not liable to carry out any
type of servicing work, under the guarantee.
3 Accessories such as Electrode Body Pads are
not covered by the guarantee.
4 Batteries and damage from leakage are not
covered by the guarantee.
5This guarantee does not confer any
rights other than those expressly set
out above and does not cover any claims
for consequential loss or damage. This
guarantee is offered as an additional
benefit and does not affect your
statutory rights as a consumer.
To activate your free 2 year warranty please register your device at the
REVITIVE website (see warranty/guarantee card).
If you prefer you can also post your registration.
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Actegy Ltd
REFLEX, Cain Road
Bracknell, RG12 1HL
United Kingdom
[phone]
Country Distributors:
International and UK
Tel: [phone]
®
Copyright © 2016 Actegy Ltd. All rights reserved. ACTEGY® and REVITIVE®
and Circulation Booster® are registered trademarks of Actegy Ltd. The REVITIVE
product is a proprietary design and is protected by applicable design laws.
AW 2694_IFU04_13378729 PD 06.2017
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