Revitive RMV, Advanced User Manual

Model number RMV

User’s Manual

PLEASE READ THE USER’S MANUAL CAREFULLY BEFORE USING THIS PRODUCT

USE ONLY AS DIRECTED

If symptoms persist, consult your healthcare professional

®

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Table of contents - REVITIVE Advanced Performance

What is inside the box? 4

Parts and Controls 5

Introduction to REVITIVE 6

Indications for use 6

How REVITIVE Advanced works 7

Important Safeguards 8

Contraindications 8

Warnings, Risks and Cautions 9-11

Instructions for use 12-23

How long should I use REVITIVE? 12

Step 1: Setting up REVITIVE Advanced for the ﬁrst time 12

Step 2: Setting up REVITIVE Advanced for use 13-14

Step 3: Using the foot pads 15-17

Step 4: Using the body pads 18-22

Step 5: Cleaning and storing 23

Replacing the batteries 23

Replacing the body pads 23

Troubleshooting 24-25

Technical Speciﬁcations 26-27

Warranty 28-29

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A

B

E

What is inside the box?

On 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.

F

AC/DC power adaptor

REVITIVE Advanced

C

D

Electrode Body Pads

Body pad cord

Remote control

AAA batteries x 2

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G

J

I

L

M

H

K

Carry handle

Control panel/display

Power ON/OFF

Foot pads

AC/DC power

adaptor socket

Body pads socket

IsoRocker

Time display

Intensity level

Controls of REVITIVE Advanced

Remote control

Control panel

Parts and Controls of REVITIVE Advanced

Parts of REVITIVE Advanced

N

IsoRocker Disabler

Intensity Control – /+

Power ON/OFF

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Introduction to REVITIVE

INDICATIONS FOR USE

• Help maintain leg vein health by increasing circulation, delivering

more oxygenated-blood and reducing swelling (oedema) in the legs, feet and ankles.

The above Indication for Use is certiﬁed by SGS United Kingdom Limited NB0120 under the Medical Devices Directive 93/42/EEC

INTENDED PURPOSE

REVITIVE devices are indicated for electrical stimulation of the lower leg to:

• Support and improve blood circulation, due to prolonged inactivity

and/or a sedentary lifestyle, in healthy individuals

• Reduce swelling volume and discomfort in the lower leg, foot and

ankle due to prolonged inactivity and/or a sedentary lifestyle, in healthy individuals

The above Intended purpose is included on the Australian Register of Therapeutic Goods (ARTG)

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HOW REVITIVE WORKS

REVITIVE delivers electrical stimulation 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 lower legs.

REVITIVE Advanced has been developed so that it is comfortable for you to use. It features an IsoRocker (patent pending) that allows for natural ankle movement when applying the electrical stimulation to your feet. Ankle movement is a key factor in increasing circulation in the lower legs. You can choose to enable or disable the IsoRocker at any time.

REVITIVE Advanced is designed to be easy to use and also comes with a remote control, which means you do not have to reach down to adjust settings during use.

REVITIVE Advanced 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.au for more information

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IMPORTANT SAFEGUARDS

READ ALL INSTRUCTIONS BEFORE USE

WHO SHOULD NOT USE REVITIVE

REVITIVE should not be used by some people.

Do not use if (contraindications):

• Fitted with an electronic implanted device such as a heart pacemaker or

Automatic Implantable Cardioverter Deﬁbrillator (AICD)

• You are pregnant

• 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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Warnings

• If you have an existing medical condition, consult with your doctor

before use.

• If you have a history of heart problems, consult your doctor before using

this device.

• If you are unsure about the suitability of the REVITIVE Advanced for you or

unsure about the cause of your symptoms, you should consult with your doctor before use.

• Do not use the body pads on your head, face, neck or chest.

• Do not apply 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

• Do not use body pads after their expiration 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.

• If you experience adverse reactions, stop using REVITIVE Advanced and talk

with your doctor.

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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.

• over the abdomen during menstruation.

• after recent surgical procedures as stimulation may disrupt your healing process.

• If your tissues are likely to bleed following an injury such as a muscle tear – it is recommended not to stimulate the immediate area within the ﬁrst 12 hours after sustaining the injury. 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.

Look for signs of skin irritation (redness), bruising or pain. If in doubt, consult your doctor.

• The long-term effects of electrical stimulation are unknown.

• 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.

IMPORTANT SAFEGUARDS

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• Do not spill liquid on the device or its accessories.

• Do not overload the electrical outlet.

• Not suitable for use by children.

• Use the REVITIVE Advanced only with the accessories supplied by, or

purchased from, the manufacturer.

• Do not open the REVITIVE Advanced 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 authorized agent.

• With the increased number of electronic devices such as personal

computers and mobile (cellular) telephones, medical devices may be susceptible to electromagnetic interference from other devices. The 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.

• It has been reported that some universal remote control devices (eg for

TV etc) can change the settings on REVITIVE if used during a treatment. If this should occur, simply adjust the time or intensity settings on REVITIVE back to where you want them to be using the REVITIVE Remote Control, or using the device Control Panel.

• 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.

SAVE THESE INSTRUCTIONS

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Instructions for use

STEP 1: SETTING UP REVITIVE FOR THE FIRST TIME

a Remove all parts from the carton:

•

AC/DC power adaptor

•

REVITIVE Advanced

• Body pads

•

Body pad cord

•

Remote control

• AAA batteries x 2

See What is inside the Box? on pages 4-5 to help identify the parts.

b Locate the remote control and insert the batteries.

Before you use REVITIVE Advanced for the ﬁrst time, read the Warnings and Cautions on pages 7-10. If in doubt, consult your doctor before using the product.

How long should I use REVITIVE?

It is recommended to use REVITIVE Advanced for 20-30 minutes per day.

Do not use REVITIVE Advanced more than 6 sessions of 30 minutes (or the equivalent) per day. This may result in muscle fatigue.

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STEP 2: SETTING UP REVITIVE FOR USE

a Turn the device over so that you can see the

IsoRocker and the IsoRocker Disabler.

• The IsoRocker allows REVITIVE Advanced to rock while stimulating your legs and feet.

• REVITIVE Advanced will begin rocking on the IsoRocker once muscle contractions are strong enough.

• The Isorocker feature can be disabled, by opening the IsoRocker Disabler. REVITIVE Advanced will then be static and it will not rock during use.

b If you want to use the IsoRocker, leave the IsoRocker

Disabler in place (ie ﬂat) on the bottom of the device, as shown.

c If you do not want to use the IsoRocker

• Open the IsoRocker Disabler on the bottom of REVITIVE Advanced. You may have to pull hard.

• Pull the IsoRocker Disabler back until it clicks open, as shown.

• To re-enable the IsoRocker, pull the IsoRocker Disabler and press into place on the bottom of the device (ie ﬂat).

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Instructions for use

d Locate the AC/DC power adaptor.

e Plug the small end of the power cord into the

opening on the side of the REVITIVE Advanced.

f Plug the power adaptor into the nearest

electrical socket.

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STEP 3: 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 Advanced on the ﬂoor in front of you.

REVITIVE Advanced 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 Advanced can help improve the delivery of electrical stimulation.

e Press the power button on the device or on the remote

control to turn REVITIVE Advanced on.

You will hear a beep and the display lights will light up. The time will read 30 minutes and Intensity will read 00.

To turn off REVITIVE at any time during operation, press the power button on the device or remote control.

Sit with both bare feet on the foot pads

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Instructions for use

f Press the (+) Intensity Control one time to

start stimulation.

Continue to increase the intensity until you can feel or see the muscles in your calves contract and relax. You can set the intensity between 1-99.

You can use the buttons on the control panel or remote control.

Press the (+) button to increase the level. Press the (–) button to decrease the level.

g Use an intensity that provides you with strong but

comfortable muscle contractions and 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.

It is normal to feel tingling or varying sensations in your calf muscles.

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 Control on the control panel or remote control before replacing your feet on REVITIVE Advanced.

REVITIVE Advanced does not vibrate.

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h The Time Display will start to count down

in minutes as the device cycles through its program.

i When REVITIVE Advanced times out, the Time

Display reads 00 and you will hear three beeps.

j REVITIVE Advanced switches itself off automatically.

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Instructions for use

STEP 4: USING THE ELECTRODE BODY PADS

REVITIVE Advanced comes with two pairs of reusable (up to 20-30 applications) body pads that can be used to deliver electrical stimulation to target speciﬁc body areas such as knees or thighs.

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.

✔

Thigh

Knee

✔

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b Clean and dry the area where you will place the

body pads.

c Make sure REVITIVE Advanced is switched off. If the

control panel is still illuminated, press the power button and turn REVITIVE Advanced off.

d Attach the ends of the body pads to the body

pad cord.

Press connectors until no gap is between them. Leaving a gap may cause discomfort.

e Plug the other end of the body pad cord into the

opening on the side of REVITIVE Advanced.

Plugging in the body cord will automatically turn

the foot pads off and intensity will reset to zero.

f Remove the plastic liner from the body pads, by

peeling it off carefully. Replace the body pads onto the plastic liner after use.

R

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Instructions for use

g Press the body pads on the area you wish to apply

electrical stimulation, as shown on page 17, gently pressing the adhesive side against the skin.

h Press the power button on the device or on the

remote control to turn REVITIVE Advanced on.

You will hear a beep and the display lights will light up. The time will read 30 minutes and Intensity will read 00.

To turn off REVITIVE at any time during operation, press the power button on the device or remote control.

i Press the (+) Intensity Control, one time, to

start stimulation.

Continue to increase the intensity until you can feel or see the muscles contract and relax. You can set the intensity between 1-99.

You can use the buttons on the device or remote control.

Press the (+) button to increase the level. Press the (–) button to decrease the level.

R

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j Use an intensity that provides you with strong but

comfortable muscle contractions and 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.

It is normal to feel tingling or varying sensations in your calf muscles.

If you feel pain or discomfort - lower the intensity of the body pads using either the (–) Intensity Control on the control panel or the remote control.

k The Time display will start to count down in

minutes as REVITIVE Advanced cycles through its program.

l When REVITIVE Advanced times out, the Time

Display reads 00 and you will hear three beeps, and the device will switch itself off automatically.

m 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.

R

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Instructions for use

n Replace the body pads onto its plastic liner after use.

o Unplug the body pad cord from the opening

on the device.

You do not need to detach the body pads from the body pad cord.

R

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STEP 5: CLEANING AND STORING REVITIVE

a Press the power button and turn REVITIVE off, if needed.

b Wipe down the foot pads with a soft damp cloth.

Do not clean with chemicals. Do not immerse REVITIVE Advanced in water.

c Store REVITIVE Advanced in a cool, dry and dust-free location.

Store out of direct sunlight.

d Place body pads back on the plastic liner.

e Store 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 cord to store

them.

Replacing the Batteries

The remote control requires two AAA 1.5V batteries to operate.

Replacing the 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 body pads can be obtained via www.revitive.com.au.

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Troubleshooting

Problem Possible Cause Solution

REVITIVE Advanced 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 99 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 99 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 99 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 foot pads at the same time (The heel end of the foot pads 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 99 you still cannot feel the stimulation then please contact your authorised dealer.

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Problem Possible Cause Solution

No power or lights to REVITIVE Advanced when it is switched on.

AC Adaptor not switched on at the electrical socket or AC Adaptor not plugged into device properly.

Check electrical socket power is switched on and the AC Adaptor is plugged into the device correctly. If still not working – contact your authorised dealer.

REVITIVE Advanced is not vibrating.

REVITIVE Advanced IS NOT DESIGNED TO VIBRATE.

The IsoRocker is not "rock ing".

It is the muscles in your legs that cause the "rocking", THE ISOROCKER IS NOT MECHANICAL.

The ISOROCKER will only rock when increased to an intensity which causes sufﬁcient calf muscle contraction. It may be that you cannot comfortably increase the intensity high enough until you get used to the sensation. It is important that intensity is adjusted to a level that is comfortable.

The device is too far in front of you.

Sit with your knees at a 90 degree angle.

The IsoRocker system is not enabled.

Ensure IsoRocker Disabler is “ﬂat”, in centre position (see page 12).

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.

When using the IsoRocker on a hard ﬂoor it makes a tapping noise.

Incorrect positioning of the device or too high an intensity level.

Adjust the positioning of the device or lower the intensity level to reduce the device tapping. Alternatively use a ﬂoor mat under the device to cushion the sound.

For more information including Frequently Asked Questions,

please visit www.revitive.com.au

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Name of product REVITIVE Advanced

Model RMV

Frequency 1Hz – 50Hz

Output current Max 15mA

Weight 1.4kg

Dimensions (with IsoRocker enabled and disabled)

enabled: 355(W)x355(H)x70(D) mm disabled: 355(W)x355(H)x85(D) mm

Power consumption 5W

AC 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 the REVITIVE Advanced

Warnings and Cautions Make sure you understand these before using the REVITIVE Advanced

Power

Time Remaining

Intensity Level

IsoRocker Disabler

Center Positive Polarity

Type BF medical electrical equipment

Class II medical electrical equipment double insulated

Technical Speciﬁcations

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The Remote Control replicates the controls found on the device

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 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.

Indoor Use Only

Do not disassemble

Operating Frequencies

38 KH

z

Operating Range Distance

0 to 25m at horizontal 0 to 18m at +/- 30 degree angle from the horizontal.

10°C

30%

40°C

90%

#YYYYMMXXXXX

LOT

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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 28 days of purchase, it should be returned to the place of purchase for it to be replaced.

If the fault develops after 28 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 warranty period, the warranty 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 warranty, the device must have been used according to the manufacturer’s instructions supplied.

EXCLUSIONS:

1 Actegy Ltd, manufacturer of REVITIVE

devices, shall not be liable to replace the goods under the terms of the warranty 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 warranty.

3 Accessories such as Electrode pads are not

covered by the warranty.

4 Batteries and damage from leakage are not

covered by the warranty.

5 This warranty does not confer any

rights other than those expressly set out above and does not cover any claims for consequential loss or damage. This warranty 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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Your international two year warranty

AUSTRALIAN WARRANTY

This device is guaranteed for 2 years against faulty material, components and workmanship.

This warranty is in addition and does not affect your statutory rights.

Proof of purchase must be produced for any warranty beneﬁt.

In the unlikely event of any device proving to be faulty, securely pack and return the item to the place of purchase accompanied by the original receipt or invoice.

Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and for compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.

NOT COVERED BY THIS WARRANTY

(Australia only)

• If the device has not been used in accordance with the manufacturers’ recommendations or Instructions.

• If the fault is deemed to be caused by abuse, misuse, neglect, modiﬁcations or improper use and or care.

• Connection to incorrect voltage or used with an incorrect power adaptor to that stamped or supplied with the product.

• Unauthorised repairs.

• Device used other than for domestic purposes.

• Excluding accessories such as Electrode body pads, gloves and bag.

• Freight and insurance costs.

If for any reason this item is replaced during the 2 year guarantee period, the guarantee on the new item will be calculated from original purchase date. Therefore it is vital to retain your original receipt or invoice to indicate the date of original purchase.

Actegy Ltd’s policy is to continually improve quality design and product quality. The company therefore reserves the right to change any speciﬁcations or to carry out modiﬁcations as deemed worthy at any time.

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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Notes

.......................................................................................................................................

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.......................................................................................................................................

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Copyright © 2015 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 2296_IFU01_9608705 PD 07.2015

Actegy Ltd REFLEX, Cain Road Bracknell, RG12 1HL United Kingdom

Tel: +44 (0)845 871 5989

Country Distributors:

International and UK

Tel: +44 (0)845 871 5989

Australia

Actegy Pty Ltd Unit 4 / 1 Newspaper Place Maroochydore QLD, 4558

Tel: 1800 505 108

New Zealand

Actegy Ltd 24B Mooreﬁeld Road Johnsonville Wellington 6037

Tel: 0800 484 325

®

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Revitive RMV, Advanced User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual