User Manual for REVITIVE models including: 5572AQ, 5572AQ Circulation Booster
User’s Manual Certified Medical Device CIRCULATION BOOSTER 6289 IFU01 17694594 1 18/01/ 2021 13:34. 2 3 What’s in the box? 4 Parts and Controls 5-6 Introduction to Revitive 7-8 Operator profile 7 Indications for use 8 Important Safeguards 9-13 Who should NOT use Revitive 9
Revitive ProHealth Circulation Booster - Alleviate tired and achy-feeling legs - Drug-Free Relief from less severe foot & leg problems for those who want to maintain good leg health : Health & Personal Care
ProHealth
User's Manual
Drug-Free Clinically Proven Certified Medical Device
Please read the User's Manual carefully before using this product
USE ONLY AS DIRECTED If symptoms persist, consult your healthcare professional
CIRCULATION BOOSTER®
6289_IFU01_17694594.indd 1
Model number 5572AQ
18/01/2021 13:34
For best results Use daily
Intensity 40+ 30-60 min for 60+ days
How-to videos
For videos of setup and using your Revitive system, go to: support.revitive.com
2-year warranty
To activate your free 2-year warranty please register your device at: support.revitive.com
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Table of contents
What's in the box? Parts and Controls Introduction to Revitive
Operator profile Indications for use Important Safeguards Who should NOT use Revitive Warnings and Cautions Safety Precautions Adverse Reactions Instructions for use Step 1: Setting up Revitive for use Step 2: Using the SoftTouch foot-pads Step 3: Cleaning and storing Troubleshooting Technical Specifications Warranty
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5-6
7-8
7 8 9-13 9 10-12 13 13 14-29 14 15-17 18 19-20 21-24 25
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What's in 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.
1 AC/DC power adaptor
Cable length 180cm
2 Revitive ProHealth
3 Remote control
4 AAA batteries x 2
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Parts and controls
SoftTouch PadsTM
Power ON/OFF
Control panel/ display
Carry Handle
AC/DC power adaptor socket
IsoRocker®
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Parts and controls
Control panel
Intensity Control /+
Time remaining
Intensity level
Remote control
Power ON/OFF
Intensity Control /+
Introduction to Revitive
Operator Profile
The intended operator profile is based on users in the home environment who may suffer from immobility, poor circulation and related issues such as pain, leg stiffness and swelling in the legs, ankles and feet. Revitive is intended for use by the end user in a non-clinical setting and without the supervision or intervention of a clinician during use. A typical user may be of any adult age range and is not specific to any demographic of gender, ethnicity or educational background.
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Introduction to Revitive
Indications for use
When using the foot-pads, Revitive it is intended to:
· Help maintain leg vein health - by increasing circulation, delivering more oxygenated blood and reducing swelling (oedema) in legs, feet and ankles.
· Improve circulation to reduce or prevent blood-pooling (stasis) - caused by poor circulation (Chronic Venous Insufficiency/varicose veins)
· Reduce Pain and discomfort in the legs/ankles/feet - caused by poor circulation (Peripheral Arterial Disease)
· Improve symptoms associated with varicose veins/ Chronic Venous Insufficiency · Improve circulation in the legs - caused by Peripheral Arterial Disease · Increase walking distance before the onset of claudication symptoms (pain) caused
by Peripheral Arterial Disease
If you are otherwise healthy and have a sedentary lifestyle or spend long periods inactive, Revitive may help to: · Alleviate tired, aching & heavy legs, including cramp · Reduce swollen feet & ankles · Help maintain leg vein health · Actively increase circulation
The above Indications for Use are certified under the Medical Devices Directive 93/42/EEC.
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Important safeguards
Read all instructions before use. Save these instructions. 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 lifethreatening 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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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 had medical or physical treatment for your pain · You have suspected or diagnosed heart disease · 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:
· 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
When applying foot-pads:
· Do not apply foot-pads directly on these areas: · 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) · near the thorax (chest) may increase the risk of cardiac fibrillation · on your head, face, neck or chest
· Ensure that any moisturiser/gel/balm is evenly applied and thoroughly absorbed into the skin before applying stimulation. There is a chance that uneven application of a moisturiser/gel/balm could increase the risk of skin irritation or burn, when using the electrical stimulation
· Symptoms may worsen during the initial treatment phase before getting better. This may occur if the body has not fully 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
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Warnings
When not to use Revitive:
· There are times you should not use Revitive. Do not use Revitive: · In the presence of electronic monitoring equipment · Together with a life-supporting medical electronic device · When you are in the bath or shower · While you are sleeping
· In conjunction with a brace or cast without first consulting with your doctor · Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally
Additional Warnings:
· Use of cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation
· Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Revitive System, including cables specified by the manufacturer
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Important safeguards
Cautions
When applying stimulation:
· 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 over-stimulation. Check for signs of skin irritation (redness), bruising or pain. If in doubt consult your doctor
· 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
· Be careful when applying stimulation: · After recent surgical procedures (within the past 6 months) 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 over-stimulation or muscle fatigue
Additional Cautions:
· The long term effects of electrical stimulation are unknown · Electrical stimulation may not work for every user, please seek advice from
your doctor
Safety Precautions
· Do not stand on the machine. Use only when seated · Do not position Revitive so that it is difficult to disconnect or turn off · Use Revitive only for its intended purpose · Do not expose Revitive to extreme heat
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· Do not spill liquid on Revitive or its accessories · Do not overload the electrical socket · Keep device out of the reach of children · Keep power cords and cables out of the reach of children to prevent risk of
strangulation · Revitive foot-pads may be used by multiple persons. Ensure device is cleaned after
each use · During use, do not touch foot-pads with your hands until Revitive has powered off · Use Revitive only with the accessories supplied by, or purchased from, the
manufacturer · Check 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 · It has been reported that some universal remote control devices (e.g. 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 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
Adverse Reactions
· If you experience adverse reactions, stop using Revitive and consult with your doctor immediately.
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Instructions for use
Step 1: Setting up Revitive for use
a Remove all parts from the box: · AC/DC power adaptor · Revitive ProHealth device · Remote control · AAA batteries x 2
See "What's in the box?" on page 4 to help identify the parts. b Locate the remote control and insert the batteries.
c Locate the AC/DC power adaptor. Plug the small end of the power cord into the socket on the side of the Revitive.
d Plug the power adaptor into the nearest electrical socket.
Before you use Revitive for the first time, read the Important Safeguards on pages 9-13. If in doubt, consult your doctor before using the product.
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Step 2: Using the SoftTouch foot-pads
For best results:
· Use Revitive foot-pads for at least 30 to 60 minutes each day, 7 days a week. If you have varicose veins (CVI), use Revitive foot-pads for 60 minutes per day.
· It is important to use Revitive at a high enough intensity to give you a strong comfortable muscle contraction. Most people achieve a strong muscle contraction over intensity level 40 (intensity range 1-99).
· If you are diagnosed with a long term medical condition such as High Blood Pressure, High Cholesterol, Diabetes, Osteoarthritis, Chronic Venous Insufficiency (CVI), Peripheral Arterial Disease (PAD) or COPD, it can take up to 8 weeks to help reduce symptoms associated with these chronic conditions.
Do not use Revitive, using EMS stimulation, for more than 6 sessions of 30 minutes (or the equivalent) per day.
a It is important that you are well hydrated. We recommend that you apply a moisturiser to the soles of the feet to help hydrate the skin and improve the delivery of electrical stimulation.
We also recommend drinking a glass of water before using Revitive.
Sit with both bare feet on the foot-pads
b Get into a comfortable seated position. For best results sit with your knees at a 90 degree angle (right angle).
c Place Revitive on the floor in front of you.
Revitive is designed to be used while seated. Never stand on the Revitive unit.
d Place both bare feet on the foot-pads. Make sure you remove all footwear, including socks/ stockings.
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Instructions for use
e Press the power button on the device or on the remote control to turn Revitive on.
You will hear a beep and the display will read 30 minutes.
To turn off Revitive at any time during operation, press the power button on the device or on the remote control.
f Press the (+) Intensity Control one time to
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start stimulation.
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You can use the buttons on the control panel or
remote control. Ensure both feet are on the foot-
pads when increasing the intensity.
Press the (+) button to increase the level.
Press the () button to decrease the level.
g Ensure you familiarise yourself with the feeling of the electrical muscle stimulation. Use on a low intensity for 30-60 minutes once per day for a few days.
Set the intensity at a level where you can feel the stimulation in your feet which creates a calf muscle contraction.
It is normal to feel tingling or varying sensations in your feet and calf muscles.
Revitive does not vibrate.
h After a few days of familiarisation, use a higher intensity that provides you with strong but comfortable calf muscle contractions.
Most people experience a strong contraction at intensity level 40 or over.
The IsoRocker® enables Revitive to rock up and down once muscle contractions are nearing the desired level. The rocking is caused by muscle contractions in the leg, and the resulting ankle movement allowed by the IsoRocker is a good indicator that the intensity level is sufficient to provide the therapy. Increasing the intensity above this level will enhance the therapy, but should not be allowed to become uncomfortable.
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You can set the intensity between 1-99. Please note that the intensity required may vary from day to day.
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
i When you have finished setting the intensity, the display reverts to the Time Display. The Time Display will count down will count down from 30 minutes as Revitive cycles through its program.
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.
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When Revitive times out, the Time Display reads 00 and you will hear
three beeps.
k
Revitive switches itself off automatically.
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Instructions for use
Step 3: Cleaning and storing Revitive
a Ensure Revitive is switched off. b Wipe down the foot-pads with a soft damp cloth.
Do not clean with chemicals. Do not immerse Revitive in water. c Store Revitive in a cool, dry and dust-free location. Store out of direct sunlight.
Replacing the Batteries
The remote control requires two AAA 1.5V batteries to operate.
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Troubleshooting
Problem
Possible Cause
Solution
Revitive is on (lights illuminated on the LED display) but I cannot feel the electrical stimulation through the footpads.
Not placing both bare feet on the foot-pads at the same time.
Your feet may be dry.
You may be dehydrated.
The intensity level may be on too low a setting.
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.
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.
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.
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 produces strong muscle contractions in your calves and is comfortable for you.
If, having tried the solutions Test the device by placing one hand
above, you still cannot feel across both foot-pads at the same time
the stimulation:
(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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Troubleshooting
Problem
Possible Cause
Solution
No power or lights to Revitive when it is switched on.
Revitive is not vibrating. The IsoRocker® is not "rocking".
AC Adaptor not switched on
Check electrical socket power
at the electrical socket or AC is switched on and the AC Adaptor
Adaptor not plugged into device is plugged into the device correctly.
properly.
If still not working contact your
authorised dealer.
REVITIVE IS NOT DESIGNED TO VIBRATE.
It is the muscles in your legs that cause the "rocking", the IsoRocker® is a pivot.
The device is too far in front of you.
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.
Sit with your knees at a 90 degree angle.
When using the IsoRocker® on a hard floor it makes a tapping noise.
My legs are aching after treatment.
Incorrect positioning of the device or too high an intensity level.
You may have the intensity on too high a setting and your muscles are being overworked.
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.
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 acclimatised to the stimulation.
For more information, including Frequently Asked Questions, please visit support.revitive.com
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Technical Specifications
Name of product Model
Frequency (+/- 10%)
Output current
Weight
Dimensions
Power consumption
AC adaptor
Power source Input (adaptor used) Output
Applied parts Parts of Revitive that in normal use come into physical contact with the user.
Durable Period (Service Life) of Device and Remote control
Revitive ProHealth 5572AQ 20Hz 44Hz Max 15mA 1.12 Kg +/- 0.5Kg 360mm (Ø) x 70.9mm (D) 5W CE Approved 100-240V AC ( ), 50/60Hz, 0.18A 5V ( ) DC ,1.0A
SoftTouch Pads (Foot-Pads) - 195cm2
4 years
The Remote Control replicates the controls found on the device
Operating Frequencies
38 KHz
Operating Range Distance
0 to 25m at horizontal 0 to 18m at +/- 30 degree angle from the horizontal.
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Technical Specifications
Output Specifications for Electrical Muscle Stimulation (EMS):
Waveform Shape Maximum Output Voltage (+/-15%) Pulse Duration (+/-10%) Net Charge @ 500 Maximum Power Density @ 500 ON Time (+/-10%) OFF Time (+/-10%)
@500
Biphasic Square symmetrical with polarity reversal 35Vp 450-970µs [0.001]mC 0.68 mW/cm² 1.90 - 8.30s 1.00 - 1.50s
The values of PULSE DURATIONS, PULSE repetition frequencies and amplitudes, including any d.c. component, shall not deviate by more than ± 20 % when measured with a load resistance within the range specified.
If confirmation is required that the Revitive works within its Essential Performance after a certain period of time, contact the manufacturer
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Symbols
Complies with European Medical Devices Directive (93/42/EEC) Device Lot number including year (YYYY) and month (MM) of manufacture can be found on the box and back of unit Item number Contraindications, Warnings and Cautions Make sure you understand these before using Revitive Power
Time Remaining Intensity Level Center Positive Polarity Class II medical electrical equipment double insulated
Type BF medical electrical equipment
Legal manufacturer of the device EU/EC European Authorised Representative
Consult instructions for use
LOT #YYYYMMXXXXX REF
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
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Technical Specifications
Symbols
UK Conformity Assessed Product conforms to all applicable U.K. legislative requirements.
FCC mark Certification mark employed on electronic products manufactured or sold in the United States which certifies that the electromagnetic interference from Revitive is under limits approved by the Federal Communications Commission
Ingress Protection Rating
Use-by date
YYYY MM DD
Humidity, temperature and air pressure limit for storage and transport
20%
90%
70°C
-20°C 1060 hPa
500 hPa
Humidity, temperature and air pressure limit for operating
conditions 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.
30%
75%
40°C
10°C
1060 hPa
700 hPa
Indoor Use Only
Medical device does not contain natural rubber latex
Do not disassemble
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Your 2-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
1 Actegy, 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 are not liable to carry out any type of servicing work, under the guarantee.
3 Accessories such as electrode pads and bags are not covered by the guarantee.
4 Remote control batteries and any damage from leakage are not covered by the guarantee.
5 This 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: support.revitive.com
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ProHealth
Actegy Ltd 1 West Point Western Road Bracknell, RG12 1HJ United Kingdom
Tel: +44 (0)845 871 5989
MDSS Schiffgraben 41 30175 Hannover, Germany.
Distributor
UK:
1 West Point Western Road Bracknell, RG12 1HJ United Kingdom
Tel: +44 (0)800 014 6377 info.uk@actegy.com
Copyright © 2021 Actegy Ltd. All rights reserved. Actegy®, Revitive®, Revitive ProHealth®, Circulation Booster®, OxyWave®, IsoRocker® and SoftTouch PadsTM are trademarks or registered trademarks of Actegy Ltd. The Actegy product is a proprietary design and is protected by applicable design laws.
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CIRCULATION BOOSTER®
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