ActiveCare+SFT® and ActiveCare+DTx

®

Patient Instruction for Use

Dear patient, This manual is designed to provide information and operation instructions for patients. 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:

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 SystemsC.E.C.T. - Continuous Enhanced Circulation TherapySFT - Synchronized Flow TechnologyDVT - Deep Vein ThrombosisPE – Pulmonary EmbolismVTE – Venous ThromboembolismLCD - Liquid Crystal Display

For any questions please contact your service provider:

Name: Tel: After office hours contact number:

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Table of ContentsIntroduction 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 recommendationfor use 4

Instructions for Use 6Unpacking 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 Components 10

Mobility and Portability 11

Temporarily Stopping the Treatment 12

Charging ActiveCare® 12

Monitoring Your Compliance Level 13

End of Treatment Period 13

Cleaning the System 14Troubleshooting 14Frequently Asked Questions 17Technical Details 18

Technical Specifications 18

Product Symbols Definition 18

Electromagnetic Interference 19

Brief Review 20

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IntroductionWhat 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):527-35

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What Is the Duration and Frequency of Use? Your physician will advise you on how many days you will be required to use the ActiveCare+SFT® or ActiveCare+DTx® System. For your maximal effectiveness, wear the device for at least 20 hours per day throughout your prescribed treatment period. This means a compliance level of 80% or higher. You can track your personal usage with the help of the special display on the device’s screen.The device is portable and powered by a rechargeable battery that lasts 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 healthcare 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 orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment.

These devices are indicated for use in:

Preventing Deep Vein Thrombosis (DVT) Diminishing post-operative pain and swelling

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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.

ContraindicationsDo 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, Cautionsand recommendation for useIt 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 physician. 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.

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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 your 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 (http://www.tsa.gov/travelers/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.

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Instructions for Use1. Unpacking and Parts IdentificationActiveCare+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 leg inflatable sleeves

3 A pair of extension tubes

4 An AC/DC adapter

5 A Patient Instruction for Use A pair of cotton stockinette - not shown

(supplied with calf sleeves only)

CAUTION: Do not use any broken or damaged device or accessories, since this may delay the treatment.Notify your service provider of any defects.

2

4 5

1

3

or

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2. Sleeve Application You can wear the cotton stockinette (provided

with calf sleeves) under the sleeves for additional comfort.

Use both sleeves, unless you were instructed differently by your physician. The sleeves are identical, and there is no left or right difference.

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.

CAUTION: Do not attach the sleeve upside down as this may cause discomfort to the patient or swelling of the foot.

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

B

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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.

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

B

A

B

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4. Device OperationA. 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.

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.

Make sure the connectors are locked.

BA

No additional action is required. Do not press “Archive”. If you mistakenly selected that option, restart the device (turn off and then on).

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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

* NOTE: When the Calf-Thigh sleeves combination is being used, the icon of Calf-Calf is displayed.

B. Wait for the automatic operation of the device. The device automatically identifies which sleeves are connected and selects the suitable treatment mode and will be displayed on the main screen.

It takes about one minute from turning the device on to the display of the main screen (next page).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 ComponentsThe main screen appears after the treatment mode is automatically selected by the device.

Compliance Level Battery Status

For physician use

Treatment Mode

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5. Mobility and PortabilityThe carrying strap has clips that can be used to hang the systems on assistive devices (such as a walker, a wheelchair, etc.).

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 maximal 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.

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.

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5.1 Temporarily Stopping the 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). In order to do so: 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.

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. The device can be charged while operating or while turned off.

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.

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

B

The device displays the charging level, using the Battery Status Indicator:

Full Low Empty

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You can track your compliance by looking at the compliance bar on the main screen.

The compliance represents the average compliance since you started to use the device and not compliance per day.

Consult with your physician if you feel that you can’t keep up with 80% compliance.

8. End of Treatment PeriodOnce the 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.

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.

7. Monitoring Your Compliance LevelIt is very important that you maintain a compliancelevel 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.

HH:mm

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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.

TroubleshootingCAUTION: 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 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. If any problem persists please contact your service provider.

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.

CAUTION: Do not wash the sleeves, as this might damage the sleeves or the device.

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Error Problem Description Steps to be takenAir leakage

The attention indicator flashes and an auditory indicator is sounded. An arrow indicates the relevant port.

1. Check connections of both sleeves and tubes.2. If the problem persists, replace sleeves and/or extension tubes.3. If the problem persists, contact your service provider.

Low battery

The attention indicator flashes and an auditory indicator is sounded.

Connect the device to the wall outlet via an AC/DC adapter.

Empty battery

The device shuts down, the attention indicator flashes and an auditory indicator is sounded.

1. Connect the device to the wall outlet via an AC/DC adapter. 2. Restart the device (the auditory indicator will continue to sound until restart).

Error Problem Description Steps to be takenNo treatment mode selected indication

The device fails to identify the attached sleeves during start up. The attention indicator flashes and an auditory indicator is sounded.

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.

Airway obstruction

The attention indicator flashes and an auditory indicator is sounded. An arrow indicates the relevant port.

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.

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Error Problem Description Steps to be takenOperation error

System attempts to restart at regular intervals. The attention indicator flashes and an auditory indicator is sounded.

If restart fails, contact your service provider.

Operation error

Operation stops and the system attempts to restart at regular intervals. The attention indicator flashes and an auditory indicator is sounded.

If restart fails, contact your service provider.

Device fails to turn on

Screen is blank, the indicators are off.

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 takenNo compliance display

Compliance is not calculated.

Contact your service provider, device should be replaced, however the unit can still be used even though the compliance is not recorded. The device should be used for at least 20 out of 24 hours.

Battery or its electrical connections are damaged

Battery cannot be charged despite being connected to a wall outlet.

Contact your service provider. However, the device can still be operated by direct connection to the wall outlet via the AC/DC adapter.

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Frequently Asked QuestionsQ: 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 (http://www.tsa.gov/travelers/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 travelling.

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: The longer you use the device, the better. ActiveCare+SFT® and ActiveCare+DTx® are designed to be comfortably used on a 24-hour basis and should be worn for at least 20 hours per day. You may use the device everywhere except in a steamy or wet environment. We recommend that you maintain your compliance level to be above 80% as indicated by the compliance bar on the LCD screen. If your compliance level falls below 80% and you feel that you can’t increase it, please consult your physician.

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Technical DetailsTechnical Specifications

SpecificationItem53/8” x 53/8” x 23/8” /13.5 x 13.5 x 6.0 cmDimensions (W x D x H)

1.65 lb / 750 grWeight7.2 VDC (NiMH rechargeable batteries)

Internally powered equipment requirements

Medical grade transformer 100-240 VAC/9.7 VDC, 50-60 Hz,400 mA

AC/DC adapter

Temperature:+410F to +1040F /+50C to +400C

Operating conditions Relative humidity: 15% to 90%, non-condensingAtmospheric pressure range: 700-1060 hPATemperature: +140F to +860F / -100C to +300C

Storage conditionsRelative humidity: 10% to 85%, non-condensing

Product Symbols DefinitionThe following symbols may appear on your device or AC/DC adapter. Here you can find their meanings:

DefinitionSymbolOperation instructions

Conforms to the European Medical Device Directive 93/42/EECCaution: Federal law restricts this device to sale by or on the order of a physician.Accompanying the name community and the address of the authorized representative in EuropeSleeves 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

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DefinitionSymbolManufacturer symbol

Year of manufactureYYYY

Device was put on the market after 13 August 2005. Conforms to the Directive 2003/108/EC on waste electrical and electronic equipment. (WEEE) of the European Parliament.Direct currentAlternating current (input, for AC/DC adapter only)

Power switch ON

Power switch OFF

FRIWO trademark (for the AC/DC adapter only)

IEC 60601-1 3rd ed (for the AC/DC adapter only)CAN/CSA-C22.2 No.601.1-M90 (for the AC/DC adapter only)Consult instructions for use (for the AC/DC adapter only)

Serial number

Catalog number

Batch code

Electromagnetic InterferenceThis System has been tested and found to comply with the limits for medical devices according to the EN 60601-1-2:2007 & IEC 60601-1-2:2007 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.

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Brief Review

Before using ActiveCare® System: Use only as prescribed by the healthcare

provider. (Check your physicians Rx on how many days you are required to use ActiveCare® System.) Use 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 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.

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ActiveCare+SFT® and ActiveCare+DTx ®

Patient Instruction for Use

Medical Compression Systems (DBN) Ltd.12 Ha’Ilan StreetPO Box 75, Or Akiva 3060000IsraelTel: +972 (4) 6266630Fax: +972 (4) 6266640E-mail: info@mcsmed.com

For additional information consult the patient video at: activecare.mcsmed.com

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EU authorized representative (for regulatory purposes only) MEDES LTD. 5 Beaumont Gate,Shenley Hill, Radlett, Herts WD7 7ARUnited KingdomTel/Fax: +44 (0) 1923859810E-mail: medes@arazygroup.com

© 2014 Medical Compression Systems, Inc. All rights reserved 0482

6520 Platt Ave. #804 West Hills, CA 91307-3218Tel: 1-800 377 5804

November 2014