Zimmer ActiveCare_OperationsandServiceManual Électrocardiographe de repos à 12 dérivations CP 150 Notice d'utilisation

ActiveCare+S.F.T.

®

and ActiveCare+DTx

®

Operation and Service Manual

(for healthcare providers)

activecare.mcsmed.com

No part of this text shall be reproduced or transmitted in any
form or by any means, electronic or mechanical, including
photocopying, recording, or by any information or retrieval
system without written permission from MCS.

© 2015 by MCS, Ltd.
ALL RIGHTS RESERVED.

NOTE: The gures in this User Manual are for
illustration purposes only, and are applicable for

®

ActiveCare+S.F.T.
ActiveCare+DTx

, HomeCare ActiveCare+S.F.T.®,

®

and HomeCare ActiveCare+DTx®,

unless specied differently.

Document Symbols, Denitions and Abbreviations

This manual contains different typefaces designed to
improve readability and increase understanding of its
content. Note the following examples:

WARNING - Identies situations or actions

which, if not avoided, may result in death or serious
injury.

CAUTION - Identies 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 clarication.

ActiveCare+S.F.T.® - 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

II A385A-0017-01 Rev05

DVT - Deep Vein Thrombosis

S.F.T. - Synchronized Flow Technology

Table of Contents

Introduction 2

Indications for Use 2
Contraindications 2
System Advantages 3
General Warnings and Cautions 3

Section 1: System Description 4

1.1 Unpacking and Parts Identication 4

1.2 Device View 5

1.3 Sleeves 6

1.3.1 Sleeve Description

1.3.2 Treatment Options

Section 2: System Operation 6

2.1 Preparations for Use 6

2.2 Sleeve Selection 6

2.2.1 Calf Sleeve Selection 7

2.2.2 Thigh Sleeve Selection 7

2.3 Sleeves Application 8

2.3.1 Calf Sleeve Application 8

2.3.2 Thigh Sleeve Application 9

2.3.3 Foot Sleeve Application 9

2.3.4 Sleeve to Device Connection 10

2.4 Device Operation 10

2.4.1 Getting Started 10

2.4.2 Main Screen Features 11

2.4.2.1 Battery Status Indicator 11

2.4.2.2 Compliance 12

6
6

2.4.2.3 Treatment Mode 12

2.4.2.4 Menu Screen 13

2.4.3 DTx Mode 14

2.5 Mobility and Portability 16

2.5.1 Charging the device 16

2.5.2 Hanging the Device 16

2.5.3 Carrying the Device 16

2.6 Temporarily Stopping the Treatment 17

2.7 End of Treatment Period 17

2.8 Cleaning the System 17

2.9 Routine Checkup 18

2.10

Device and Battery Storage 19

Section 3: Troubleshooting 20
Section 4: Parts Replacement 22

4.1 Battery Replacement 22

4.2 Carrying Strap Replacement 23

Section 5: Technical Details 23

5.1 Classication and Standards 23

5.2 Electromagnetic Interference 24

5.3 Product Symbols' Denition 24

5.4 Technical Specications 26

5.5 Accessories 26

Section 6: Warranty and Returns 27

6.1 Warranty 27

6.2 Returning the Device 28

Section 7: Discharge from Hospital 29

A385A-0017-01 Rev05 1

Introduction

®

This guide is designated for ActiveCare+S.F.T.

®

ActiveCare+DTx

Systems.

A full understanding of the technical principles and
clinical applications related to ActiveCare+S.F.T.

®

ActiveCare+DTx

Systems is necessary before use. Please

read this entire manual before activating the system.

Indications for Use

The ActiveCare+S.F.T.® 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 ow velocity in individuals experiencing venous

impairment or reduced pulsatility (dysfunction of

the muscle pump) when blood ow 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 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

and

®

and

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 insufciency

Reducing edema

®

The ActiveCare+S.F.T.

and ActiveCare+DTx® Systems

are intended to provide external compression in

synchrony with the specic patient’s natural venous
blood ow return prole in order to achieve a high
pulsatile venous blood ow.

®

In addition, the ActiveCare+DTx

System can detect

hemodynamic changes in venous blood ow.

Contraindications

Do not use the ActiveCare+S.F.T.® or ActiveCare+DTx®
System in the following cases:

Fresh, pre-existing Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Leg gangrene

2 A385A-0017-01 Rev05

Recent skin graft
Acute thrombophlebitis
Medical situations where increased venous and

lymphatic return are undesirable

System Advantages

Full patient mobility – The device is lightweight and

portable

Higher compliance – as demonstrated by a clinical

The compact sleeve design enables user to easily

Systems can work either with the AC/DC adapter

Unique hemodynamic prole - System operation is in

In addition, the ActiveCare+DTx® System is designed for:

DVT prevention on a 24/7 basis, together with real time

1 Froimson, M. I., et al. Venous thromboembolic disease reduction with a

1

study

move about

connected to applicable power source (wall outlet)
or built-in rechargeable battery power

synchronization with the natural, respiratory related

venous phasic ow

detection of possible impairment in the leg’s venous

®

ow. The ActiveCare+DTx

portable pneumatic compression device. J. Arthroplasty 24, 310–6 (2009).

is not a diagnostic tool.

General Warnings and Cautions

CAUTION: Federal law restricts this device to sale by or
on the order of a licensed healthcare practitioner.

WARNING: ActiveCare+S.F.T.® or ActiveCare+DTx®

system is not intended for use in close proximity to

ammable anesthetics or within oxygen rich environment.

CAUTION: Although the device is durable, it is advised
to avoid high impact, rough handling or dropping to
prevent device damage.

CAUTION: Inspect patient’s leg(s) under treatment at

least once a day for signs of pathological skin changes.
CAUTION: Inspect legs of high-risk patients at least

three times a day. Double check the positioning and
proper adjustment of the sleeve before and during
device operation. High-risk patients included - elderly;
debilitated; paralyzed; unconscious; with diffuse
malignancy; with severe peripheral neuropathies;
known severe arterial vasculopathy or patients with
continuous epidural analgesia.

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.

NOTE: None of the system components is made with
natural rubber latex.

A385A-0017-01 Rev05 3

Section 1: System Description

1.1 Unpacking and Parts Identication

CAUTION: Do not use any broken or damaged device

accessories, since this may delay the treatment.

or
Notify your service provider of any defects.

Before use, make sure you have the following parts,
and verify their propriety:

Device with removable carrying strap:

1

ActiveCare+S.F.T.
ActiveCare+S.F.T.
or HomeCare ActiveCare+DTx

2

Medical grade AC/DC adapter with 14.76 f t /4.5 m

electric cord

3

One pair of 3.9 ft /1.2 m extension tubes

4

Cradle for hanging the system (optional)

Operation and Service Manual

5

Final Quality Control Form (not shown)

The Patient Instructions for Use Manual (for
outpatients) will be provided by the healthcare provider
(refer to Section 7).

®

(1A) or HomeCare

®

(1B) or ActiveCare+DTx® (1C)

®

(1D).

1

A

1

C

1

B

1

D

2

3

It is recommended to save the original box for storage
of the ActiveCare+S.F.T.® and ActiveCare+DTx® Systems.

NOTE: The sleeves are supplied separately.

4 A385A-0017-01 Rev05

4

5

1.2 Device View

Frontal View

7

6

5

1. Infrared communication (for MCS technical

support internal use)

2. Attention indicator

3. LCD screen

4. Buzzer (opening)

5. Manifold port (x2)

6. Operation push button (x4)

7. ON/OFF indicator - Green light indicates power on

Rear View

1

2

3

4

5

1

4

2

3

1. DC power jack

2. Device label. Refer to section 5.3 for the full

denitions of the symbols.

3. Serial number label

4. ON/OFF power switch

5. Battery cover

A385A-0017-01 Rev05 5

1.3 Sleeves

WARNING: Sleeves are intended for single patient

use in order to avoid cross-contamination.
Dispose of used sleeves according to established

procedures.

1.3.1 Sleeve Description

®

The ActiveCare+S.F.T.® and ActiveCare+DTx
use three types of sleeves, available in different sizes:

Calf Sleeve

Small/Medium/Large/
Extra large

Thigh Sleeve

Small/Medium/Large

Foot Sleeve

Single size

Sleeves bags are marked by different colors (purple, blue,

green or orange) for easy identication of sleeves sizes.

Same color code is used for both calf and thigh sleeves.

1.3.2 Treatment Options

The versatile
Systems have numerous treatment options; each mode
is automatically selected according to the combination
of sleeves being used (single sleeve or any combination
of two sleeves).

ActiveCare+S.F.T.® and ActiveCare+DTx

Systems

®

Section 2: System Operation

For additional information consult the Training Video for
professionals at: activecare.mcsmed.com

2.1 Preparations for Use

Before applying the system to a patient, please take
the following steps:

1. Make sure all the systems' parts (device, sleeves,

AC/DC adapter, etc.) are clean, intact and working

correctly (refer to sections 2.8, 2.9).

2. Make sure the device’s battery is fully charged (refer

to section 2.9).

3. Select the sleeves type (according to the physician’s

instruction), and match their size to the patient’s

legs (refer to section 2.2).

2.2 Sleeve Selection

In order to select the most appropriate sleeve for a

specic patient:

Measure the height and circumference as described

below.
Identify the sleeve size according to the relevant

diagram or the Calf Sleeve Selection (CSS) tool.

NOTE: If the specic patient’s maximal circumference is

within the range of two different sleeve sizes, choose either
one of them (according to the medical team preference).

6 A385A-0017-01 Rev05

2.2.1 Calf Sleeve Selection

Make sure that the calf height (the distance
between the upper level of the Malleoli (a)
and the lower level of the Tibial Tuberosity
(b)) is at least 11.5''/ 29.2 cm.

Measure the maximal circumference of the

patient’s calf using the colored Calf Sleeve
Selection (CSS) tool or a measuring tape.

CSS tool is designed to help matching

calf circumference and calf-sleeve
size with the sleeve bag color.

Small

2.2.2 Thigh Sleeve Selection

Make sure that the thigh height (the

distance between the upper level of
the Malleoli (a) and the mid-thigh (b))
is at least 20'' / 50.8 cm.

Measure the circumference of the

patient’s mid-thigh (b).

Identify the thigh sleeve size using the

following tting tool diagram.

Small

Mid-Thigh Circumferece (Inches)

Medium

Large

Upper-Calf Circumference Inches

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Bag
Color

Purple Small
Blue Medium
Green Large
Orange Extra large

Sleeve Size

Calf Circumference
Inches cm

<14 < 35.5
12-18
16-22 40.5-56
20-25 51-63.5

30.5-45.5

Extra large

Part Number

A201C-020S-10
A201C-120S-10
A201C-220S-10
A201C-420S-10

Medium

Large

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

Bag
Color

Purple Small
Blue Medium

Green Large

Sleeve
Size

Thigh Circumference
Inches cm

< 20 < 51
18-24 45.5–61

22-32 56–81.5

Part Number

A201T-0480-10
A201T-1480-10

A201T-2480-10

A385A-0017-01 Rev05 7

2.3 Sleeve Application

2.3.1 Calf Sleeve Application

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

CAUTION: A loosely fastened sleeve can result in
ineffective treatment, while an overly tight sleeve can
cause discomfort.

NOTES:

For patient positioning and comfort, connectors can

be adjusted by slightly rotating the sleeves.

It is recommended to apply the sleeves over cotton

stockings for patient’s comfort.

Sleeves and extension tubes are identical for both

the right and left legs.

Wrap the sleeve around the calf and fasten it according
to the numbers in the drawing.

A

Check that the sleeve is snugly t but still allows the
insertion of two ngers.

B

8 A385A-0017-01 Rev05

2.3.2 Thigh Sleeve Application

2.3.3 Foot Sleeve Application

Wrap the sleeve around the leg and fasten it according
to the numbers in the drawing.

A

Check that the sleeve is snugly t but still allows the
insertion of two ngers.

B

Place the foot over the open sleeve and align the heel
with the end of wide edge of the sleeve. Fasten it
according to the numbers in the drawing.

A

Check that the sleeve is snugly t but still allows the
insertion of two ngers.

B

A385A-0017-01 Rev05 9

2.3.4 Sleeve to Device Connection

2.4.1 Getting Started

Connect the sleeves to the device before turning it on.

A.

For thigh and calf sleeves
only: connect one end of the
extension tube to the sleeve
connector. The white arrows
should be pointed towards
each other.

B. For all sleeves: connect the

other end of the extension
tube to the device. The
white arrow should be
facing upwards. Make sure
the connectors are locked.

2.4 Device Operation

Turning the device on:

Press the power switch
located on the back of the
device to ON position.

After turning the device on, the self-test mode is

initiated. The ON/OFF and attention indicators ash

while the auditory indicator beeps. The device logo is
displayed.

or

Wait for the display of the Conguration Setup Screen
(see next page).

To display patient’s data select “Archives” (see section

2.4.2.4, for the medical team use).
This selection will terminate treatment initiation.

or

10 A385A-0017-01 Rev05

The system automatically
activates the self-test mode

and begins to inate the sleeve

sequentially, starting from the

lowest sleeve cell. Sleeve ination

occurs one leg at a time. Sleeves types are automatically

identied and treatment mode is selected accordingly.

Treatment mode selection takes about one minute.

CAUTION: Visually examine that all cells in the sleeve

inate correctly.

Main screen (see next section) is displayed. Check that
the treatment mode icon matches the sleeves that are
being used.
If the device is assigned for a new patient, select Menu

to set a New Patient within the rst 3 minutes from the

device startup (the time period that the hourglass icon
is displayed on the main screen).

NOTE:

If auditory indicator sounds or attention indicator

ashes or the attention screen is displayed - refer to the

Troubleshooting (Section 3).

2.4.2 Main Screen Features

The four main screen features are:

Compliance

Level

2

Treatment Mode

3

2.4.2.1 Battery Status Indicator

The battery status indicator represents the battery
charging level.

1

4

Battery

Status

Menu

Options

CAUTION: If removal or changing of sleeve type is
needed: Turn off the device, connect or disconnect the
applicable sleeve, and turn it on again.

Fully charged Low battery Empty

Very low battery

A385A-0017-01 Rev05 11

For low or empty battery, see Troubleshooting in section 3.

In ActiveCare+DTx® Device, the estimated

battery operation time is displayed below
the battery status indicator (only when
the device is battery operated).

HH:mm

The power cord is visible while the device is

connected to the wall outlet. This indicates
that the battery is being charged.

2.4.2.3 Treatment Mode

The Treatment Mode is automatically selected during
start-up. The numbers below the icons indicate the
average pressure applied to the limb (measured by
millimeters of mercury (mmHg)).

2.4.2.2 Compliance

Compliance percentage is calculated according to the
following equation:

Total time the device was used

X 100 = % Total Compliance

Total time from initial treatment

The compliance indicator represents compliance level:

For exact compliance percentage, use patient code
option (refer to section 2.4.2.4 -Compliance).

12 A385A-0017-01 Rev05

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.

2.4.2.4 Menu Screen

To display the menu screen, select “Menu” option in the

main screen. The following options are displayed:

Compliance

DTx Mode (Only for ActiveCare+DTx

®

, while Calf-Calf is

used.)
New Patient/Patient Code: New Patient option is

available only for the rst 3 minutes from the device

startup (the time period that the hourglass icon is
displayed on the main screen).
After three minutes, the New Patient option is replaced
by the Patient Code option. In order to set a New Patient
code after the rst three minutes, turn off the device,
turn it on again, and choose the New Patient option.

NOTE: While Menu screen is displayed, the system
continues to operate as usual. If no option is selected,
the system returns to main screen.

Setting New Patient:

Select New Patient on the
Menu screen.
The following screen is
displayed:
Back - return to the previous
screen
No - the system will default
to current patient.
Yes - a New Patient code will
be assigned.
The Patient Code is a
combination of the starting
date and time.

To return to the main screen, press Ok.

Patient Code:

In the Menu screen, select Patient Code to display
the Patient Code and treatment starting date (see
above).

A385A-0017-01 Rev05 13

Compliance

Select Compliance to access the list of Patient Codes.
Scroll up or down on the list of patients using the arrow
buttons.

Select - choose the highlighted
code to present the treated

patients’ data screen (see

below).
Back - return to the previous
screen.

Patient Data screen displays:

Start date
Total compliance

Total days of treatment

Select Data to display detailed patient compliance. The

information is available only for the current patient (rst

patient on the list):

Overall total compliance

(Total)

Total days of treatment

(Days)

Compliance on any other

date (scroll down the list)

NOTE: Compliance data is

unavailable during the rst

three minutes after turning
the device on.

2.4.3 DTx Mode

Relevant for ActiveCare+DTx® Only

The ActiveCare+DTx® System can provide information

regarding suspected proximal venous ow impairment.

This situation can be caused by several patho­physiological mechanisms, and DVT is only one of them.
The system is not intended for DVT diagnosis. Only a licensed
physician can diagnose DVT based upon clinical judgment
combined with standard DVT diagnostic procedures.

NOTE: The DTx mode can only be activated when Calf­Calf Sleeves are used.

Select DTx Mode in the Menu
screen to start the Clinical
Questionnaire.

Yes/No: To answer the questions.
Repeat: Start over the Questionnaire.
Exit: Return to the main screen.

If no selection is made within 10 minutes, the system
will automatically return to prophylactic treatment mode.

14 A385A-0017-01 Rev05

At the end of the Clinical Questionnaire, the Detection
Procedure shall begin:

Start: Start detection test.
Back: Re-answer the questions.
Exit:

Return to the main screen.

Test performance:

Maintain the following optimal conditions:

Patient is lying in supine position with upper body

elevated to about 30°.

Patient is breathing normally, focusing on breath.

Patient is avoiding unnecessary movements and

talking. The patient should be informed about the
length of the test.

At the end of the test (or if Stop was pressed), the

probability of the existence of proximal venous ow

obstruction is displayed.

Venous ow obstruction

was not detected

Venous ow obstruction is suspected in

the leg treated by the device left port

The duration of the Detection Procedure is about 7 minutes.
However, it can be stopped any time by pressing Stop.

NOTE: The prophylactic treatment mode will not be
active during the detection test.

During the test, a graphical
presentation of the collected
data will be displayed about
once a minute (white bars: left

black bars: right leg).

leg,

Venous ow obstruction is

suspected in both legs

In case an obstruction was not suspected - press

Venous ow obstruction is suspected in

the leg treated by the device right port

Exit

to return to the prophylactic treatment mode. Otherwise
the treatment mode will be automatically resumed
within 10 minutes.

If venous ow obstruction was suspected – an auditory

indicator alerts every minute. The system will not return
to the prophylactic treatment mode unless Exit is
selected.

A385A-0017-01 Rev05 15

2.5 Mobility and Portability

2.5.1

Charging the device:

CAUTION: Improper removal may damage the AC/DC

adapter.

WARNING: Use only the AC/DC adapter supplied by
MCS. Using a non-original adapter may cause serious
injury.

Connect the AC/DC adapter
to the DC jack on the back of
the device, and connect it to a
wall outlet.

In order to disconnect

the
device from the main outlet,
detach the AC/DC
the wall outlet.

adapter from

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).

2.5.2 Hanging the Device

®

Hang the ActiveCare+S.F.T.® or ActiveCare+DTx

System
on a patient assistive device (walker, wheelchair, etc.)
or bed rail:

Use the carrying straps clips, or
Use the ActiveCare® Cradle

Hanging to bed with straps

Hanging to bed with cradle

CAUTION: Do not cover the device while it is being used
or charged since this might damage the device.

2.5.3 Carrying the Device

®

The ActiveCare+S.F.T.® and ActiveCare+DTx
are lightweight and allow full patient mobility.

While walking with the system, disconnect the AC/DC

Systems

16 A385A-0017-01 Rev05

adapter from the system and shorten
the extension tubes to prevent tripping.
Loop and fasten the tubes using the
clips on the carrying strap.
The device should be carried in a
crossover shoulder fashion and should
not be hanged loose around the neck.

WARNING: Extension tubes may
become tangled when walking with
the ActiveCare+S.F.T.® and

ActiveCare+DTx

Systems. Adjust

length to

their
avoid tripping
injury or
equipment
damage.

®

The patient 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).

2.7 End of Treatment Period

Once the treatment is completed, disconnect the
system as follows:

1. Turn the device off.

2. Disconnect the sleeve and the extension tubes.

3. Remove the sleeve(s) from the patient, and discard used

sleeves. Keep the extension tubes, they are re-useable.

WARNING: Sleeves are intended for single

patient use in order to avoid cross-contamination.
Dispose of used sleeves according to established
procedures.

4. Disconnect the AC/DC adapter from the device and

from the main power outlet.

2.6 Temporarily Stopping the Treatment

In order to remove the device for a limited time, to be
used again by the same patient:

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.

2.8 Cleaning the System

WARNING: Do not perform any maintenance while

the device is in use.

CAUTION: The device is not waterproof. Liquid
penetration might damage the device.

CAUTION: Do not use harsh cleaners or detergents, as
this may damage the device or accessories.

A385A-0017-01 Rev05 17

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

Make sure that the equipment is completely dry before
re-using it.

1. Device cleaning

Make sure the device is off and is not connected to

an external power outlet. Gently wipe the external
surfaces of the device with a soft-cleaning pad,
slightly dampened with 70% ethanol.

2. Manifold cleaning

Wipe the exterior and the interior of the manifold

with a damp cloth using 70% ethanol. Do not use
soap and water. Do not allow liquid to penetrate the
manifold itself.

3 Extension Tubes cleaning

Wipe the extension tube exterior with a damp

cloth using 70% ethanol or soap and water.
Do not immerse the tubes in liquid. Pay close

attention to the tube’s creases and areas around

the connectors.

Visually inspect the extension tube after every

cleaning. Ensure that the silicon O-rings on the
connectors are present and in good condition.

NOTE: It is recommended to replace the extension

tubes every 4-6 months.

4. Carrying straps cleaning

Wipe the carrying straps with a damp cloth using

70% ethanol or soap and water. Replace the straps
if any sign of wear and tear is visible.

5. AC/DC adapter cleaning

WARNING: Ensure the AC/DC adapter is
completely dry before using it. Failure to do so may
result in injury or equipment damage.

Wipe the exterior of the AC/DC adapter with a damp

cloth using 70% ethanol or soap and water. Visually
inspect the AC/DC adapter after every cleaning to
ensure that the cord and AC/DC adapter connectors
are in good condition.

2.9 Routine Checkup

Before handing the device to a new patient follow the
instructions below:

1. Clean all parts of the system according to cleaning

procedures (section 2.8).

2. Visually inspect the carrying strap, push buttons,

LCD screen, plastic covers, ON/OFF switch, DC
jack, manifold ports and battery door. If any part

is damaged, contact your service supplier or
biomedical engineer.

18 A385A-0017-01 Rev05

3. Make sure the device

is off. Attach the AC/DC
adapter and verify that

the message: “Battery is
Charging Device is OFF” is

displayed.

4. Fully charge the battery

until the “Charging
Completed Device is OFF”

message appears.

5. Connect a pair of Calf Sleeves to the device and turn

it on. Verify that:

The ON indicator is steady green.
The ERR indicator turns on and then off.
Buzzer beeps once.
LCD display turns totally black and then lights up.
No error messages appear.

All cells in both sleeves are inated correctly,

from the bottom to the top, sequentially.

Calf-Calf mode is indicated after about 1 minute.

NOTE: If calf sleeves are not applied on legs, the

Thigh-Thigh mode indication might be presented.

6. Leave the device on for 10 minutes. Ensure that no

error messages appear.

7. Disconnect the device from the AC/DC adapter and

leave it on for 10 minutes (while using the battery).
Ensure that no error messages appear.

It is recommended to operate the device by battery for

at least 2 hours to ensure sufcient battery lifetime.

2.10 Device and Battery Storage

Fully charge the system. When the device is off and connected
to the AC power source, the following screens will appear:

Before storing, detach the accessories. Avoid folding

the extension tubes to prevent kinks.

Store the device according to the storage instructions

(section 5.4).

If the device will not be used for 30 days or longer, have
your service supplier or biomedical engineer:

1. Fully charge the battery pack.

2. Remove the battery pack.

3. Store the battery separately according to storage

conditions.

NOTE: A complete discharge and recharge of the battery
pack (1 full cycle) should take place every six months.

A385A-0017-01 Rev05 19

Section 3: Troubleshooting

NOTE: When the device detects a problem, the auditory

indicator is sounded, and the attention indicator ashes.
The operation continues. Once the problem is xed, the

indicators switch off automatically and the main screen is

displayed, unless specied differently in the following table.

Error

No
treatment
mode
selected
indication

Device fails
to turn on

20 A385A-0017-01 Rev05

Problem Description

The device fails to
identify the attached
sleeves during start
up. The Attention

indicator ashes and

an auditory indicator
is sounded.

Screen is blank, the
indicators are off.

Steps to be taken

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, replace
the device.

Turn the device
off and allow the
battery to recharge
for at least 30
minutes before
turning it on again.

Error

Airway
obstruction

Air leakage

Low
battery

Problem Description

The attention indicator

ashes and an

auditory indicator is
sounded. An arrow
indicates the relevant
port.

The attention indicator

ashes and an

auditory indicator is
sounded. An arrow
indicates the relevant
port.

The attention indicator

ashes and an auditory

indicator is sounded.

Steps to be taken

1. Check sleeves

and tubes for
kinks.

2. If the problem
persists, replace
sleeves and/or
extension tubes.

3. If the problem
persists, replace
the device.

1.

Check
connections of both
sleeves and tubes.

2. If the problem
persists, replace
sleeves and/or
extension tubes.

3.

If the problem
persists, replace the
device.

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

Error

Empty
battery

Battery or
its electrical
connections
are
damaged

Operation
error

Problem Description

The device shuts
down, the attention

indicator ashes and

an auditory indicator
is sounded.

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

Steps to be taken

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).

The device can
still be operated by
direct connection to
the wall outlet via
the AC/DC adapter.

1.

Replace the battery

2.

If the problem
persists, replace
the device.

If restart fails,
replace the device.

Error

Operation
error

No
compliance
display

Problem Description

Operation stops and
the system attempts
to restart at regular
intervals. The attention

indicator ashes and

an auditory indicator is
sounded.

Compliance is not
calculated.

Steps to be taken

If restart fails,
replace the device.

Device should be
replaced; However,
the unit can still be
used even though
the compliance is
not recorded. The
device should be
used according to
the prescription.

System attempts to restart
at regular intervals.
The attention indicator

ashes and an auditory

indicator is sounded.

A385A-0017-01 Rev05 21

Section 4: Parts Replacement

CAUTION: Do not attempt to repair the device. Only
MCS authorized personnel may repair the device.
Unauthorized service might cause equipment damage.

4.1 Battery Replacement

CAUTION: Use only the battery pack supplied by
MCS. Alternative power source may cause permanent
damage to the device.

If a fully charged battery is sufcient for less than

three hours of calf-calf operation it is recommended to
replace it.

1. Turn the device off, and

disconnect the AC/DC adapter.

2. Put the device upside down

on a soft surface.

3. Remove the screw from the

cover. Do not lose the screw.

4. You may use a tip of a small

at screwdriver to open the

battery cover.

6. Lift and disconnect the

battery.

7. Connect the new battery

according to the connectors
alignment.

8.

Fold the wires into the
intended space and place
the battery (labels facing
up).

9.

Align the cover with the

slots and push it in until a

“click” is heard. Then, push

it down until another “click”
is heard.

10.

Secure the battery door

with its screw.

7

5. Remove the cover.

22 A385A-0017-01 Rev05

11.

Fully charge the battery.

NOTE: Discard the old battery according to national
standards, established practices and recycling plans.

4.2 Carrying Strap Replacement

Section 5: Technical Details

1. The carrying strap is supplied partially

assembled.

2. Insert the strap through

the opening in the device
(A) from the top, and loop it
through the clamp (B) from

B

below.

3. Leave a 0.4’’ / 1 cm edge

and rmly secure the clamp

on it.

5.1 Classication and Standards

The ActiveCare+S.F.T.®, HomeCare ActiveCare+S.F.T.®,
HomeCare ActiveCare+DTx® and ActiveCare+DTx® System

are designed and manufactured

according to the following

s

equipment classication and standards:

Technical
and Quality
Assurance

A

ANSI/AAMI ES 60601-1:2005(R):2012+A1:201
2+C1:2009+A2:2010 and CAN/CSA-C22.2 No.
60601-1:14, Medical Electrical Equipment – Part 1:
General Requirements for Basic Safety and essential
Performance.
IEC 60601-1-2 Edition 3:2007-03 Medical Electrical
Equipment - Part 1-2: General Requirements
For Basic Safety And Essential Performance ­Collateral Standard: Electromagnetic Compatibility ­Requirements And Tests
IEC 60601-1-6 Edition 3.0 2010-01, Medical Electrical
Equipment -- Part 1-6: General Requirements For
Basic Safety And Essential Performance - Collateral
Standard: Usability).
AAMI /ANSI /IEC 62366:2007 Medical Devices ­Application Of Usability Engineering To Medical Devices.
IEC 60601-1-11 Edition 1.0 2010-04, Medical
Electrical Equipment - Part 1-11: General
Requirements For Basic Safety And Essential
Performance - Collateral Standard: Requirements For
Medical Electrical Equipment And Medical Electrical
Systems Used In The Home Healthcare Environment
{Including Technical Corrigendum 1(2011)

A385A-0017-01 Rev05 23

Degree of
Protection
Against
Electric
Shock

Classication

According
to Medical
Device
Directive
93/42/EEC

Class II, Applied Part Type BF, Internally
powered.

IIa

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.

5.3 Product Symbols' Denition

DenitionSymbol

5.2 Electromagnetic Interference

This system has been tested and found to comply with the
limits for medical devices according to the EN 60601-1­2:2007 and 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:

24 A385A-0017-01 Rev05

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

Power switch OFF

YYYY

A non-sterile item

FRIWO trademark (for Friwo AC/DC adapters only)

IEC60601-1 3rd ed (for Friwo AC/DC

Keep dry

NRTL approval mark, Canada and USA

adapter only)

CAN/CSA-C22.2 No.601.1-M90 (for Friwo AC/
DC adapter only)

IEC60601-1 3rd ed (for Megmeet AC/DC
adapter only)

Manufacturer symbol

Consult instructions for use (for the AC/DC
adapter only)

Year of manufacture

Storage or operation temperature range

Catalog number

Storage and/or operation humidity range

Batch code

Package content: Device

Serial Number

Package content: AC/DC adapter

Device was put on the market after 13
August 2005. Conforms to the Directive
2003/108/EC on waste electrical and

Package content: Extension tubes

electronic equipment
(WEEE) of the European Parliament.

Direct current

Package content: User Manual

Keep away from sunlight

Alternating current (input, for AC/DC adapter

only)

Fragile, handle with care

Power switch ON

Package recycling information

A385A-0017-01 Rev05 25

5.4 Technical Specications

Operation modes Thigh sleeve - single/pair

Item Specication

Dimensions (W x D x H) 5⅜" x 5⅜" x 2⅜"/

13.5 x 13.5 x 6.0 cm

Weight 1.65 lb / 750 gr

Internally powered

equipment requirements

AC/DC adapter Medical grade transformer

Calf Sleeve small

Calf Sleeve medium

Calf Sleeve large

Calf Sleeve extra large

Thigh Sleeve small 20" x 22" (51 cm x 56 cm)

Thigh Sleeve medium 20" x 26½" (51 cm x 67.5 cm)

Thigh Sleeve large 20" x 34¾" (51 cm x 88 cm)

Average compression

pressure applied to the

limb

7.2 VDC (NiMH rechargeable

batteries)

100-240 VAC / 9.7 VDC,

50-60 Hz, 0.5A max

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: 50 mmHg ±10%

Calf sleeve: 50 mmHg ±10%

Foot sleeve: 130 mmHg ±10%

Operating conditions

Storage conditions
(product with batteries)

Storage conditions
(product without batteries)

Battery storage conditions
(long-term)

List of cables

Calf sleeve - single/pair

Foot sleeve - single/pair

Combined (two sleeves)

Temperature: +41°F to +104°F
/

+5°C

to+40°C

Relative humidity: 15% to 90%,
non-condensing

Atmospheric pressure range:
700-1060 hPA

Temperature: +14°F to +86°F /

-10°C to +30°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

26 A385A-0017-01 Rev05

5.5 Accessories

Part Number Description

®

A502B-0001-01 (US)

ActiveCare+S.F.T.
A502B-0001-04 (EU)
A502B-0001-06 (Kr)
A502B-0001-08 (AU)
A502B-0001-10 (UK)

A502B-0002-01 (US)
A502B-0002-02 (EU)

ActiveCare+S.F.T.® HomeCare

System
A502B-0002-03 (Kr)
A502B-0002-04 (AU)
A502B-0002-05 (UK)

A502B-0004-01 (US)

ActiveCare+DTx® System
A502B-0004-02 (EU)
A502B-0004-03 (Kr)

A502B-0005-01 (US)
A502B-0005-02 (EU)

ActiveCare+DTx® HomeCare

System
A502B-0005-03 (Kr)

A201C-020S-10 Calf Sleeve with Stockinette -

small (5 pairs/box)

A201C-120S-10 Calf Sleeve with Stockinette -

medium (5 pairs/box)

A201C-220S-10 Calf Sleeve with Stockinette -

large (5 pairs/box)

A201C-420S-10 Calf Sleeve with Stockinette -

extra large (5 pairs/box)

System

A201T-0480-10

Thigh Sleeve - small (5 pairs/box)

A201T-1480-10 Thigh Sleeve - medium

(5 pairs/box)

A201T-2480-10

Thigh Sleeve - large (5 pairs/box)

A201F-1280-10 Foot Sleeve (5 pairs/box)

A501A-1201-10 Extension tubes - Standard 3.9ft

/1.2 m (5 pairs/box)

A501A-2001-10

Extension tubes - Long 6.6 ft /

2.0 m (5 pairs/box)

A501O-2001-10 OR Extension Tubes 6.6 ft / 2.0

m (5 pairs/box)

H301H-0002-02 (US)
A301A-0001-01 (EU)
A301A-0003-03 (Kr)
A301A-0004-02 (AU)

Medical grade AC/DC adapter
with 14.8 ft /4.5 m electric cord

A301A-0005-01 (UK)

503-A-0002-20 Rechargeable battery pack

A504A-1550-10

Carrying straps (10 units/box)

502-C-0004-01 ActiveCare® Cradle

380-A-0001-00 Calf Sleeve selection tool

measuring tape

A385A-0017-01 Rev05 27

Section 6: Warranty and Returns

6.1 Warranty

The retailer will grant the guarantee only if the complete
product is returned together with the original invoice/
receipt issued to the consumer.

This product is guaranteed by MCS for a period of one
year after the date of purchase. The proper construction,
workmanship and materials of this product are
guaranteed by MCS. During this period of guarantee,
MCS will repair or replace the defective product or any
defective parts without charge for labor or parts.
The guarantee does not cover any of the following:

1. Damages of any kind caused accidentally or from

misuse.

2. Transportation costs and risks.

3. Costs for repairs and/or defects resulting from

repairs carried out by unauthorized persons.

4. Periodic check-ups, maintenance and repair.

5. Failure or wear of accessories or other attachments

other than the operating unit itself and power supply,
unless explicitly guaranteed above.

6. Costs arising from non-acceptance of a claim.

NOTE: In case guaranteed service is required, apply to
an authorized MCS distributor or to your retailer (from
whom the product was purchased).
Repair or replacement under the guarantee does not
imply any extension or renewal of the guarantee period.

6.2 Returning the Device

Medical Compression Systems guarantees that your

®

ActiveCare+S.F.T.

free from defective material and workmanship.
Our obligation under this warranty is limited to the
repair of devices and transformers returned to the
indicated service address, transportation charges
prepaid, within one year of delivery to the original

purchaser. Specically, MCS agree to service and/or

adjust any instrument as required if returned for that
purpose, and to replace and repair any part that, upon
our examination, is proven to have been defective.
This warranty does not apply to the tube assembly or
the individual disposable thigh, calf or foot sleeve or
to equipment damaged through shipping, tampering,
negligence and/or misuse, including liquid immersion,
autoclaving, or ETO sterilization.
To replace the device during warranty period, or report
about a malfunction please contact

[e-mail] or use MCS’s website

(https://returns.mcsmed.com).

and ActiveCare+DTx® Devices are

28 A385A-0017-01 Rev05

Based on the submitted information MCS will issue a

Return Goods Authorization (RGA) number and specic

shipping instructions.

®

To qualify for credit, the ActiveCare+S.F.T.

®

ActiveCare+DTx

Device must be tagged with the

or

following information:

1. Invoice number.

2. Date of purchase.

3. Serial number.

Section 7: Discharge from Hospital

Before a patient is discharged from hospital to
home or rehabilitation facility, with the HomeCare

®

ActiveCare+S.F.T.
ActiveCare+DTx

sure that:

The patient is aware of the length of use (compliance

per day and overall duration of therapy)

The patient knows how to operate the system

The patient knows how to correctly apply the sleeves

The patient receives a copy of the Patient Instruction

for Use

The patient is trained on troubleshooting

The patient knows when to contact the physician

The patient reviews the training video available on

MCS's website (activecare.mcsmed.com)

, ActiveCare+S.F.T.®, HomeCare

®

or ActiveCare+DTx® System, make

The patient has written contact details to call in case

of technical problems

A385A-0017-01 Rev05 29

For US customers:

For any questions please contact

®

ActiveCare

[phone]

Customer Service:

Medical Compression Systems (DBN) Ltd.

12 Ha’Ilan Street

PO Box 75, Or Akiva 3060000
Israel
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

®

ActiveCare+S.F.T.® and ActiveCare+DTx

Operation and Service Manual

ALL RIGHTS RESERVED © 2016 by MCS, Ltd.

For additional information visit our website

activecare.mcsmed.com

EU authorized representative (for
regulatory purposes only) MEDES LTD.

5 Beaumont Gate,
Shenley Hill, Radlett, Herts WD7 7AR
United Kingdom
Tel/Fax: [phone]
E-mail: [e-mail]

ActiveCare® is
a trademark of MCS
Medical Compression
Systems Inc.

MCS, Inc., 2352 Main Street
P.O. Box 1608, Concord, MA 01742
T [phone], F [phone]

© 2016 Medical Compression Systems, Inc. All rights reserved

A385A-0017-01_Rev05

May 2016