ProSanté - Electronic muscle stimulator REVITIVE - Free user manual and instructions

USER MANUAL ProSanté REVITIVE

Table of contents What is inside the box? 4 Parts and Controls 5 Introduction to REVITIVE 6-7 Indications for use 6-7 How REVITIVE works 7 Important Safeguards 8-11 Who should NOT use REVITIVE 8 Warnings and Cautions 9-10 Safety Precautions 10-11 Adverse Reactions 11 Instructions for use 12-23 How do I get the most from REVITIVE? 12 Step 1: Setting up REVITIVE for the first time 12-13 Step 3: Using the foot-pads 13-15 Step 4: Using the Body Pads

16-20 Step 5: Cleaning and storing 21 Replacing the Body Pads 21 Troubleshooting 22-23 Technical Specifications 24-26 Warranty 27

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. Control panel/display Power ON/OFF Foot-pads Power adaptor socket Body Pad socket Power adaptor REVITIVE ProHealth Electrode cord Parts and Controls Electrode Body Pads Time display Intensity level Control panel Intensity Control – /+

Introduction to REVITIVE Indications for use REVITIVE is intended to:

• Improve circulation to reduce or prevent blood-pooling (stasis) - due to a sedentary lifestyle or long periods sitting or standing

• Increase muscle strength to help regain mobility in the legs aected by being immobile due to COPD, osteoarthritis or following surgery.

• Help maintain leg vein health - by increasing circulation, delivering more oxygenated-blood 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 foot & leg discomfort

• Actively increase 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

• 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 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 Body Pads aer 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

• Ensure that any moisturiser/gel/balm is evenly applied and thoroughly absorbed 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 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 o 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 aected 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. Important Safeguards

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 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 • Aer 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 • Aer 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 device out of the reach of children• Keep power, electrode cords and cables out of the reach of children to prevent risk of strangulation• REVITIVE may be used by multiple persons, ensure device is cleaned aer each use

• Use REVITIVE only with the accessories supplied by, or purchased from, the manufacturer• Check Body Pads, Electrode cords and cables periodically for damage • Do not position the REVITIVE so that it is diicult to disconnect it from the mains supply • 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 aected 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• Aer 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 Important Safeguards

Instructions for use Step 1: Setting up REVITIVE for the first time a Remove all parts from the box:

• REVITIVE ProHealth device

• Electrode cord See What is inside the Box? on pages 4-5 to help identify the parts. b Locate the power adaptor. How do I get the most from REVITIVE? For best results:

• Use REVITIVE foot-pads for at least 30 to 60 minutes each day, 7 days a week.

• 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 1-50).

• If you are diagnosed with a long term medical condition such as High Blood Pressure, High Cholesterol, Diabetes, Osteoarthrtis, Chronic Venous Insuiciency (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. c Plug the small end of the power Electrode cord into the opening on the side of the REVITIVE. d Plug the power adaptor into the nearest electrical socket.

Step 2: Using the foot-pads a It is important that you are hydrated. We recommend drinking a glass of water before using REVITIVE. You may also apply a moisturiser to the soles of the feet to help hydrate the skin. Hint: Applying a moisturising lotion to the soles of the feet before using REVITIVE can help improve the delivery of electrical stimulation. 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. Sit with both bare feet on the foot-pads

Before you use REVITIVE for the first time, read the Warnings and Cautions on pages 8-11. If in doubt, consult your doctor before using the product.

e Press the power button on the REVITIVE. 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 o the device at any time during operation, press the power button. f Press the (+) Intensity Control one time to start stimulation. Press the (+) button to increase the level. Press the (–) button to decrease the level. g Ensure you familiarise yourself with the feeling of Electrical Muscle Stimulation (EMS). 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 and which creates a calf contraction. It is normal to feel tingling or varying sensations in your calf muscles. REVITIVE does not vibrate. h Aer 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. You can set the intensity between 1-50. Please note that the intensity required may vary from day to day. 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. i The Time Display will start to count down in minutes as REVITIVE cycles through its program. j When REVITIVE times out, the Time Display reads 00 and you will hear three beeps. k The REVITIVE switches itself o automatically.

Instructions for use

b Clean and dry the area where you will place the Body Pads. c Make sure REVITIVE is switched o. If the control panel is still illuminated, press the power button and turn REVITIVE o. d Attach the ends of the Body Pads to the Electrode Cord. Press connectors until there is no gap between them. Leaving a gap may cause discomfort. e Plug the other end of the Electrode Cord into the opening on the side of REVITIVE. Plugging in the Electrode Cord will automatically turn the foot-pads o. Step 3: Using the Electrode Body Pads Electrode Body Pads are for single person use only. Do NOT share body pads with others. 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. The Body Pads cannot be used at the same time as the foot-pads. Using the Body Pads will automatically turn the foot-pads o. a Select the area you wish to apply electrical stimulation to. Example Body Pad placements are shown below:

Use REVITIVE Body Pads in EMS mode as and when required, from 30 minutes per day. Do not use REVITIVE in EMS mode for more than 6 sessions of 30 minutes (or the equivalent) per day. This may result in muscle fatigue. Do NOT use the Body Pads on your head, face, neck or chest

Knee Lower back Back of Shoulder

f Remove the plastic liner from the Body Pads, by peeling it o carefully. Replace the Body Pads onto the plastic liner aer use. g Press the Body Pads on the area you wish to apply electrical stimulation to, as shown on page16, gently pressing the adhesive side against the skin. h Press the power button on the REVITIVE. You will hear a beep and the display lights will read 30 minutes. To turn o the device at any time during operation, press the power button. i Press the (+) Intensity Control, one time, to start stimulation. Press the (+) button to increase the level. Press the (–) button to decrease the level. j Ensure you familiarise yourself with the feeling of Electrical Muscle Stimulation (EMS). Use on a low intensity for 30 minutes once per day for a few days. Instructions for use

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 your muscles you are treating. k Aer 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. l The Time display will start to count down in minutes as REVITIVE cycles through its program. m When REVITIVE times out, the Time display reads 00 and you will hear three beeps, and the device will switch itself o automatically. If you feel pain or discomfort:

• Lower the intensity of the Body Pads using the (–) Intensity Control.

• You can also choose to stop therapy before the end of the 30 minute session to avoid skin irritation. You can do this by pressing the power button.

Instructions for use n Ensuring that the device has switched itself o, then gently peel the Body Pads from the skin. Do not pull the Body Pads o the skin using the Electrode cords as this may damage the cords. o Replace the Body Pads onto its plastic liner aer use. p Unplug the Electrode cord from the opening on the device. You do not need to detach the Body Pads from the Electrode cord.

Step 4: Cleaning and storing REVITIVE a Ensure REVITIVE is switched o. b Wipe down the foot-pads with a so 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. d Place Body Pads onto 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 Electrode cords to store them. 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.

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 aer 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. Electrode cord is connected to device. Disconnect the Electrode cord - the foot-pads will not work while the Electrode 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. No power or lights to REVITIVE 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 is not vibrating. REVITIVE IS NOT DESIGNED TO VIBRATE. My legs are aching aer treatment. You may have the intensity on too high a setting and your muscles are being overworked. Leave adequate time aer each treatment to allow the muscles to recover (just like aer 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. Problem Possible Cause Solution

Technical Specifications Name of product REVITIVE ProHealth Model RLV Frequency 1Hz – 50Hz Output current Max 8.5mA Weight 1.13kg Dimensions Ø 355 mm x 77(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 Complies with European Medical Devices Directive (93/42/EEC) Device serial number including year (YYYY) and month (MM) of manufacture can be found on the box and back of unit Item number Contraindications This describes situations where you should not use REVITIVE Warnings and Cautions Make sure you understand these before using the REVITIVE Power Time Remaining #YYYYMMXXXXX S/N REF 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 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 Ingress Protection Rating Use-by date Humidity, temperature and air pressure limit for storage and transport Humidity, temperature and air pressure limit for operating conditions Aer 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. -20°C 20% 70°C 90% 500 hPa1060 hPa10°C30% 40°C 75% 700 hPa1060 hPa

Your 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 aer 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 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 sta (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. 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 oered as an additional benefit and does not aect your statutory rights as a consumer. To activate your free 2 year warranty please register your device at: www.revitive.com/myrevitive Indoor Use OnlyMedical device does not contain natural rubber latexDo not disassemble Technical Specifications