ActiveCare+SFT and ActiveCare+DTx Patient Instructions for Use

Transcription

1 ActiveCare+SFT and ActiveCare+DTx Patient Instructions for Use

2 Dear patient, This manual is designed to provide information and operation instructions for patients and/or their care providers. You can use the following space and guiding questions to record any important notes regarding your treatment with the ActiveCare System: My physician s name: My physician s phone number: My physician has instructed me to use the ActiveCare+SFT / ActiveCare+DTx System for days, hours per day. I need to check for any skin irritation at least times per day. Special notes: For any questions please contact ActiveCare Customer Service (24/7): (800) Document Symbols, Definitions and Abbreviations This manual contains different typefaces designed to improve readability and increase understanding of its content. Note the following examples: WARNING - Identifies situations or actions which, if not avoided, may result in death or serious injury. CAUTION - Identifies situations or actions which, if not avoided may result in minor injury, or damage to the equipment or other property. NOTE - Sets apart special information or important instruction clarification. ActiveCare+SFT - Is a registered trademark of Medical Compression Systems, Ltd. ActiveCare+DTx - Is a trademark of Medical Compression Systems, Ltd. MCS - Medical Compression Systems C.E.C.T. - Continuous Enhanced Circulation Therapy SFT - Synchronized Flow Technology DVT - Deep Vein Thrombosis PE Pulmonary Embolism VTE Venous Thromboembolism LCD - Liquid Crystal Display II A385A _Rev05

3 Table of Contents Introduction 2 What is DVT? 2 How Does ActiveCare Prevent DVT? 2 Why Has Your Doctor Prescribed ActiveCare for You? 2 What Is the Duration and Frequency of Use? 3 Indications for Use 3 Contraindications 4 General Warnings, Cautions and recommendations for use 4 Instructions for Use 6 Unpacking and Parts Identification 6 Sleeve Application 7 Calf Sleeve Application 7 Thigh Sleeve Application 8 Foot Sleeve Application 8 Sleeve to Device Connection 9 Device Operation 9 Main Screen Features 10 Mobility and Portability 11 Temporarily Stopping the Treatment 12 Charging the ActiveCare Device 12 Monitoring Your Compliance Level 13 End of Treatment Period 13 Cleaning the System 14 Troubleshooting 14 Frequently Asked Questions 17 Technical Details 18 Technical Specifications 18 Product Symbols Definition 19 Electromagnetic Interference 20 Brief Review 21 A385A _Rev05 1

4 Introduction What is DVT? DVT stands for Deep Vein Thrombosis. Patients that are confined to bed or undergoing major surgeries (such as total knee or hip replacement) are at high risk of blood clot formation that can lead to Deep Vein Thrombosis (DVT) in the legs. A blood clot that has formed can break off and travel through the bloodstream towards the lungs (called an embolus). If it reaches the lungs it might block the blood flow and cause Pulmonary Embolism (PE). PE can damage the lungs and other organs of the body and is a life threatening condition. DVT and PE are collectively known as Venous Thromboembolism (VTE). How Does ActiveCare Prevent DVT? ActiveCare+SFT and ActiveCare+DTx are a safe and highly effective way to improve blood flow in the veins and to help prevent DVT. It delivers Continuous Enhanced Circulation Therapy (C.E.C.T.) to the lower extremities of the body. It works by applying intermittent, sequential compression to the legs in a systematic pattern, increasing the speed of blood flow in the veins and reducing the risk of clot formation. Why Has Your Doctor Prescribed ActiveCare for You? A study of 196 patients demonstrated no serious bleeding events. 1 The systems are effective non-invasive VTE preventative treatment, with no required blood draw at home. The systems are small and portable, so they can be worn during normal daily activities and while you sleep, providing continuous therapy. 1. Colwell C.W., Froimson M.I., Mont M.A. et al., Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with LMWH. J Bone Joint Surg Am 2010;92(3): A385A _Rev05

5 What Is the Duration and Frequency of Use? Your physician will advise you on how many days and hours per day you will be required to use the ActiveCare+SFT or ActiveCare+DTx System. You can track your personal usage with the help of the special display on the device s screen. For maximal effectiveness following orthopaedic surgery, wear the device for at least 20 hours per day throughout your prescribed treatment period. This means a compliance level of 80% or higher. The device is portable and powered by a rechargeable battery that lasts for up to 6 hours (when fully charged), so you can continue the therapy during almost all of your regular activities. Indications for Use The ActiveCare+SFT and ActiveCare+DTx Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopaedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment and can be provided directly to the patient for home use. These devices are indicated for use in: Preventing Deep Vein Thrombosis (DVT) Diminishing post-operative pain and swelling A385A _Rev05 3

6 Reducing wound healing time Patients at risk for Deep Vein Thrombosis (DVT) and related Pulmonary Embolism (PE) (Venous Thromboembolism (VTE)) Treatment of venous stasis Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers Enhancing blood circulation Treatment of chronic venous insufficiency Reducing edema The ActiveCare+SFT and ActiveCare+DTx Systems are intended to provide external compression in synchrony with the specific patient s natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow. Contraindications Do not use the ActiveCare+SFT or ActiveCare+DTx System in the following cases: Fresh, pre-existing Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Leg gangrene Recent skin graft Acute thrombophlebitis Medical situations where increased venous and lymphatic return are undesirable General Warnings, Cautions and recommendations for use It is important to carefully read the instructions for proper use. CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. CAUTION: Although the device is durable, it is advised to avoid high impact, rough handling or dropping to prevent device damage. If the system is not working, your service provider should repair or replace it. 4 A385A _Rev05

7 WARNING: If you are unable to use the device for more than 5 hours contact your physician immediately, to prevent potential VTE. CAUTION: Check the skin of your legs at least once a day. If you experience any discomfort, pain, swelling, blistering, sensation changes, skin irritation, skin breakdown, or any other unusual reaction, consult your physician immediately and notify your service provider. CAUTION: For the following patient groups, additional care should be taken by checking skin at least three times a day and double checking the positioning and proper adjustment of the sleeve: elderly, exhausted (mentally or physically), unconscious, paralyzed, suffering from terminal cancer, suffering from severe peripheral neuropathy, suffering from a disease of the blood vessels in the legs or receiving continuous epidural therapy for pain reduction. CAUTION: The device is not waterproof. Liquid penetration might damage the device. DO NOT wear when bathing/showering. CAUTION: Inappropriate conditions (e.g. leaving the device in the trunk of a car or exposing it to direct sunlight) may damage the equipment. Store or transport the device and its accessories according to the storage conditions listed at the end of this manual. Allergy information: None of the system components is made using natural rubber latex. NOTE: If you plan to fly, refer to the Transportation Security Administration (TSA) website ( airtravel/specialneeds/index.shtm), which includes information about procedures for travel with medical equipment. The device does not interfere with backscatter X-ray and millimeter wave technologies. You can use the device while going through automated screening. If you travel abroad, make sure you use the supplied ActiveCare AC/DC adapter with AC plug (prongs) that fits your destination power system. A385A _Rev05 5

8 Instructions for Use 1. Unpacking and Parts Identification 1 ActiveCare+SFT and ActiveCare +DTx Systems include the following components: 1 A lightweight battery-operated device (with rechargeable battery and carrying strap) 2 A pair of inflatable leg sleeves 3 A pair of extension tubes 4 An AC/DC adapter 5 A Patient Instructions for Use A pair of cotton stockinette - not shown (supplied with calf sleeves only) 2 or 3 CAUTION: Do not use any broken or damaged device or accessories, since this may delay the treatment. Notify your service provider of any defects A385A _Rev05

9 2. Sleeve Application The sleeves may be worn over a simple cotton stockinette (provided with calf sleeves), thin pajama bottoms or tube socks. They may also be worn under sweat pants or pajama bottoms to hide the extension tubes. Use both sleeves, unless you were instructed differently by your physician. The sleeves are identical, and there is no left or right difference. 2.1 Calf Sleeve Application A. Wrap the sleeve around your calf and fasten it according to the numbers in the drawing. B. Check that the sleeve is snugly fit but still allows the insertion of two fingers. A For comfort, connectors can be adjusted by slightly rotating the sleeves CAUTION: A loosely fastened sleeve can result in ineffective treatment, while an overly tight sleeve can cause discomfort. B CAUTION: Do not attach the sleeve upside down as this may cause discomfort or swelling of the foot. A385A _Rev05 7

10 2.2 Thigh Sleeve Application A. Wrap the sleeve around your leg and fasten it according to the numbers in the drawing. B. Check that the sleeve is snugly fit but still allows the insertion of two fingers. A 2.3 Foot Sleeve Application A. Place the foot on the opened sleeve. The extension tube should be next to your ankle. Fasten the sleeve according to the numbers in the drawing. B. Check that the sleeve is snugly fit but still allows the insertion of two fingers. A B B 8 A385A _Rev05

11 3. Sleeve to Device Connection Extension tubes are identical and there is no right or left difference. You may use either end of the extension tube to connect to the sleeve or device. A. Connect one end of the extension tube to the sleeve connector. The white arrows should be pointed towards each other (not relevant for foot sleeve). B. Connect the other end of the extension tube to the device. The white arrow should be facing upwards. 4. Device Operation A. Press the power switch located at the back of the device to ON position. After turning the device on, the Configuration Setup Screen is shown on the LCD and the sleeves should immediately start to inflate, from the bottom to the top. NOTE: If auditory indicator sounds or attention indicator flashes or the attention screen is displayed - refer to the Troubleshooting section in this manual. A Make sure the connectors are locked. B No additional action is required. Do not press Archive. If you mistakenly selected that option, restart the device (turn off and then on). A385A _Rev05 9

12 B. Wait for the automatic operation of the device. The device automatically identifies which sleeves are connected and selects the suitable treatment mode which will be displayed on the main screen. CAUTION: Visually examine that all cells in the sleeve inflate correctly. It takes about one minute from turning the device on for the display to appear on the main screen. NOTE: If it is necessary to add, remove or change the sleeves, turn the device off, perform the change and turn it on again. 4.1 Main Screen Features The main screen appears after the treatment mode is automatically selected by the device. Compliance Level Battery Status During the first 3 minutes the system calculates your compliance and an hourglass is displayed. Check that the treatment mode icon matches the sleeve(s) that you are wearing. Calf-Calf* Foot-Foot Thigh-Thigh None-Calf None-Foot None-Thigh Combined Calf-Foot Combined Thigh-Foot Treatment Mode For physician use * NOTE: When the Calf-Thigh sleeves combination is being used, the icon of Calf-Calf is displayed. 10 A385A _Rev05

13 5. Mobility and Portability The carrying strap has clips that can be used to hang the systems on assistive devices (such as a walker, a wheelchair, etc.). For your convenience, carry the device in a crossover shoulder way (do not wear the system hanging loose around the neck). WARNING: Extension tubes may become tangled when walking with the ActiveCare+SFT and ActiveCare+DTx Systems. Adjust their length to avoid tripping injury or equipment damage. CAUTION: Do not cover the device while it is being used or charged since this might damage the device. The ActiveCare+SFT and ActiveCare+DTx Systems are light weighted and allow full patient mobility. While walking with the System, disconnect the AC/DC adapter from the System and shorten the extension tubes to prevent tripping. Loop and fasten the tubes using the clips on the carrying strap. A385A _Rev05 11

14 5.1 Temporarily Stopping the Treatment If you remove the device for a limited time, with the intent to use it again: 1. Turn off the device. 2. Disconnect the extension tubes from the sleeve. 3. Remove the sleeves. 4. Keep the sleeve(s) and the device with the extension tubes for continuation of treatment. You may take the device off during self-care (i.e. showers) or for brief periods (such as to check the skin surface under the sleeves). 6. Charging the ActiveCare Device WARNING: Use only the AC/DC adapter supplied by MCS. Using a non-original adapter may cause serious injury. For complete battery charging, it is recommended to connect the device to the wall outlet while you sit or lay down. The device can be charged while operating or while turned off. To charge the device: A. Connect the supplied ActiveCare AC/DC adapter to the power supply jack located at the back of the device. B. Plug the AC/DC adapter to a wall outlet. A In order to disconnect the device from the main outlet, detach the AC/DC adapter from the wall outlet. Grasp the body of it and pull it out in a straight direction. Do not pull the cord (as this might damage the wires) and do not pull the adapter at an angle (as this might bend the prongs). CAUTION: Improper removal may damage the AC/DA adapter. Disconnect the AC/DC adapter from the power supply jack before getting up to walk. When you re not using the device, turn it off. B 12 A385A _Rev05

15 The device displays the charging level, using the Battery Status Indicator: compliance since you started to use the device and not compliance per day. Full Low Empty In ActiveCare+DTx Device, the estimated battery operation time is displayed below the Battery Status Indicator (only when the device is battery operated). An icon of a battery connected to a power cord indicates that the device is connected to a wall outlet via the AC/DC adapter. HH:mm 7. Monitoring Your Compliance Level It is very important that you use the device according to your prescription. You can track your compliance by looking at the compliance bar on the main screen. The compliance represents the average If you had an orthopaedic surgery, maintain compliance level of 80% or higher. This can be achieved by using the device on a daily basis for at least 20 out of 24 hours, for the entire therapy duration set by your physician. Consult with your physician if you feel that you can t keep up with 80% compliance. 8. End of Treatment Period Once the total treatment is completed, disconnect the system as follows: 1. Turn the device off. 2. Remove the sleeves from your legs. 3. Disconnect the extension tubes from the device and the sleeve. 4. Return the device to your service provider together with the AC/DC adapter and extension tubes. A385A _Rev05 13

16 Cleaning the System WARNING: Do not perform any maintenance while the device is in use. CAUTION: The device is not waterproof. Do not get it wet or expose to steamy environment. Make sure that the equipment is completely dry before using it. CAUTION: Do not use harsh cleaners or detergents, as this may damage the device or accessories. The device is supplied to you cleaned and disinfected. There is no need to clean it again. However, if for any reason you feel it needs additional cleaning, follow these steps: 1. Turn the device off and unplug the AC/DC adapter. 2. Gently wipe the device with a soft cloth moistened with 70% ethanol (alcohol) solution. Allow appropriate drying time before turning the device on. 3. Wipe the carrying straps and the extension tube exterior with a damp cloth using 70% ethanol or soap and water. Do not immerse the extension tubes in liquid CAUTION: Do not wash the sleeves, as this might damage the sleeves or the device. 14 A385A _Rev05 The disposable sleeves supplied to you are new. You may clean the inner surface of the sleeves (same way it was explained for the device). The sleeves are not machine washable. Troubleshooting CAUTION: Do not unscrew or open the hard plastic casing of the device and do not attempt to repair the device. Only MCS authorized personnel may repair the device. Unauthorized service might cause equipment damage. Consult your service provider or ActiveCare Customer Service for any product malfunction or any questions related to the operation of the ActiveCare+SFT or ActiveCare+DTx Device or their accessories. If a problem in the operation of the device is detected: The attention indicator flashes An auditory indicator is sounded An error screen appears with graphic explanation of the problem. To correct the problem, press the Help button and follow the instructions. If any problem persists please contact your service provider or ActiveCare Customer Service.

17 Error Problem Description Steps to be taken No treatment mode selected indication Airway obstruction The device fails to identify the attached sleeves during start up. The attention indicator flashes and an auditory indicator is sounded. The attention indicator flashes and an auditory indicator is sounded. An arrow indicates the relevant port. 1. Check that the sleeves and the extension tubes are securely attached, and check for kinks in the tubing. 2. If the problem persists, replace the sleeves and/or extension tubes. 3. If the problem persists, contact your service provider. 1. Check sleeves and tubes for kinks. 2. If the problem persists, replace sleeves and/or extension tubes. 3. If the problem persists, contact your service provider. Error Problem Description Steps to be taken Air leakage 1. Check connections of both sleeves and tubes. 2. If the problem persists, replace The attention indicator sleeves and/or flashes and an auditory extension tubes. indicator is sounded. 3. If the problem An arrow indicates the persists, contact relevant port. your service provider. Low battery Empty battery The attention indicator flashes and an auditory indicator is sounded. The device shuts down, the attention indicator flashes and an auditory indicator is sounded. Connect the device to the wall outlet via an AC/DC adapter. 1. Connect the device to the wall outlet via the AC/DC adapter. 2. Restart the device (the auditory indicator will continue to sound until restart). A385A _Rev05 15

18 Error Problem Description Steps to be taken Operation error If restart fails, contact your service provider. Operation error Device fails to turn on System attempts to restart at regular intervals. The attention indicator flashes and an auditory indicator is sounded. Operation stops and the system attempts to restart at regular intervals. The attention indicator flashes and an auditory indicator is sounded. Screen is blank, the indicators are off. If restart fails, contact your service provider. Turn the device off and allow the battery to recharge for at least 30 minutes before turning it on again. Error Problem Description Steps to be taken No compliance display Battery or its electrical connections are damaged Compliance is not calculated. Battery cannot be charged despite being connected to a wall outlet. Device should be replaced; However, the unit can still be used even though the compliance is not recorded. Use the device according to your prescription and contact your service provider. Device should be replaced; However, the device can still be operated by direct connection to the wall outlet via the AC/DC adapter. contact your service provider. 16 A385A _Rev05

19 Frequently Asked Questions Q: Can I travel with the device? A: You can freely carry and use the ActiveCare System while traveling by plane or by car. The device does not interfere with backscatter X-ray and millimeter wave technologies and can be used while going through automated screening. For more information please refer to the Transportation Security Administration (TSA) website ( airtravel/specialneeds/index.shtm). If you travel abroad, make sure you use the supplied ActiveCare AC/DC adapter with AC plug (prongs) that fits your destination power system. Note: The device does NOT contain lithium batteries. Q: Is it possible to use a different AC/DC adapter than the one that I received with the device? A: No! You must only use the ActiveCare adapter that you received together with the device. Make sure to take the adapter with you when you are traveling. Q: Do I need to clean the device or leg sleeves? A: The device is supplied to you cleaned and disinfected. There is no need to clean it again. The leg sleeves are supplied to you new and are for your personal use only. If for any reason you feel the device or its sleeves need additional cleaning, follow the cleaning instructions section in this manual. Q: Is the device sensitive to heat or water? A: The device is sensitive to both heat and water. It should not be covered by pillows or blankets or taken into a wet or steamy environment such as the shower, swimming pool or rain. Q: How do I know that my compliance level is OK? A: Your compliance is indicated by the compliance bar on the LCD screen. ActiveCare+SFT and ActiveCare+DTx are designed to be comfortably used on a 24-hour basis. You may use the device everywhere except in a steamy or wet environment. The device should be worn according to your prescription. If you had an orthopaedic surgery, it is recommended that you maintain your compliance level to be above 80% (at least 20 hours per day). If your compliance level falls below 80% and you feel that you can t increase it, please consult your physician. A385A _Rev05 17

20 Technical Details Technical Specifications Item Dimensions (W x D x H) Weight Internally Powered equipment Requirements AC/DC adapter Operating Conditions Calf Sleeve small Calf Sleeve medium Calf Sleeve large Calf Sleeve extra large Specification 5 3 / 8 x 5 3 / 8 x 2 3 / 8 / 13.5 x 13.5 x 6.0 cm 1.65 lb / 750 gr 7.2 VDC (NiMH rechargeable batteries) Medical grade transformer VAC/ 9.7 VDC, 50-60Hz, 0.5A max Temperature: F to F / +5 0 C to C Relative Humidity: 15% to 90%, non-condensing Atmospheric Pressure range: hpa 11½ x 17⅜ (29.2 cm x 44 cm) 11½ x 21½ (29.2 cm x 55 cm) 11½ x 25½ (29.2 cm x 65 cm) 12 x 28½ (30.5 cm x 72.5 cm) Thigh Sleeve small Thigh Sleeve medium Thigh Sleeve large Average compression pressure applied to the limb Operation modes Storage Conditions (product with batteries) Storage conditions (product without batteries) Battery storage conditions (long-term) List of cables 20 x 22 (51 cm x 56 cm) 20 x 26½ (51 cm x 67.5 cm) 20 x 34¾ (51 cm x 88 cm) Thigh sleeve: 50 mmhg ±10% Calf sleeve: 50 mmhg ±10% Foot sleeve: 130 mmhg ±10% Thigh sleeve - single/pair Calf sleeve - single/pair Foot sleeve - single/pair Combined (two sleeves) Temperature: F to F / C to C Relative Humidity: 10% to 85%, non-condensing Temperature: +14 F to +158 F / -10 C to +70 C Relative humidity: 10% to 93%, non-condensing Temperature: 14 F to +86 F / -10 C to +30 C Relative humidity: 10% to 85%, non-condensing Power supply low voltage cable 18 A385A _Rev05

21 Product Symbols Definition The following symbols may appear on your Device or AC/DC adapter. Here you can find their meanings: Symbol Definition Operation instructions Conforms to the European Medical Device Directive 93/42/EEC CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Accompanying the name community and the address of the authorized representative in Europe Sleeves and extension tubes are Type BF applied parts Class II equipment Not made with natural rubber latex Caution For single patient use A non-sterile item Keep dry NRTL approval mark, Canada and USA YYYY Manufacturer symbol Year of manufacture Device was put on the market after 13 August Conforms to the Directive 2003/108/EC on waste electrical and electronic equipment. (WEEE) of the European Parliament. Direct current Alternating current (input, for AC/DC adapter only) Power switch ON Power switch OFF FRIWO trademark (for Friwo AC/DC adapters only) IEC rd ed (for Friwo AC/DC adapter only) CAN/CSA-C22.2 No M90 (for Friwo AC/ DC adapter only) IEC rd ed (for Megmeet AC/DC adapter only) Consult instructions for use (for the AC/DC adapter only) Serial number Catalog number Batch code Storage or operation temperature range A385A _Rev05 19

22 Storage and/or operation humidity range Package content: Device Package content: AC/DC adapter Package content: Extension tubes Package content: User Manual Keep away from sunlight Fragile, handle with care Package recycling information Electromagnetic Interference This System has been tested and found to comply with the limits for medical devices according to the EN :2007 & IEC :2007 standards. These limits are designed to provide reasonable protection against harmful interference in typical medical installations. This equipment generates and radiates radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving device. Increase the distance between the equipment and other device(s). Connect the equipment into an outlet or circuit different from the one that the other device(s) are connected. 20 A385A _Rev05

23 Brief Review Before using ActiveCare System: Use only as prescribed by the licensed healthcare practitioner. (Check your Rx on how many days you are required to use ActiveCare System.) Usually, orthopaedic surgery patients should use the device daily for at least 20 hours = 80% compliance. Make sure all parts are intact and complete. In cases of broken, damaged or missing components, refrain from using it and notify your service provider immediately. Read the Patient Instruction for Use provided. While Using ActiveCare System: Follow the instructions for sleeves application and adjustments. Perform skin checks at least once a day, (more frequently for high risk patients). Notify your physician of any adverse reactions. Before getting out of bed or chair to walk, make sure to loop and fasten the tubes using the clips on the carrying strap in order to avoid falling. Also, detach the AC/DC adapter from the device. The device is not waterproof. Do not get it wet or expose to steamy environment. To clean the device or the sleeves, gently wipe with a soft cloth moistened with 70% ethanol (alcohol) solution. The sleeves are not machine washable. Possible reasons for error indicators (refer to Troubleshooting section) Air blockage Air leakage Low battery If the device is not working properly, contact your service provider or ActiveCare Customer Service for repair or to receive a replacement device. If you are unable to use the device for more than 5 hours contact your physician immediately. At the end of therapy: Turn the device off and return it to your service provider together with the AC/DC adapter and extension tubes. A385A _Rev05 21

24 ActiveCare+SFT and ActiveCare+DTx Patient Instructions for Use For additional information consult the patient video at: activecare.mcsmed.com For any questions please contact ActiveCare Customer Service (24/7): (800) Medical Compression Systems (DBN) Ltd. 12 Ha Ilan Street PO Box 75, Or Akiva Israel Tel: +972 (4) Fax: +972 (4) EU authorized representative (for regulatory purposes only) MEDES LTD. 5 Beaumont Gate, Shenley Hill, Radlett, Herts WD7 7AR United Kingdom Tel/Fax: +44 (0) medes@arazygroup.com ActiveCare is a trademark of MCS Medical Compression Systems Inc. MCS, Inc., 2352 Main Street P.O. Box 1608, Concord, MA T (800) , F (844) Medical Compression Systems, Inc. All rights reserved 0482 May 2016 A385A _Rev05