Tactile Medical Actitouch User manual

USER GUIDE
ACTITOUCH®SYSTEM
Adaptive Compression Therapy

ii
Table of Contents
Chapter 1
Component List ................. 1
Chapter 2
Product Description ............. 2
2.1 Sustained Compression
Mode .......................2
2.2 Intermittent Pneumatic
Compression Mode ..........3
Chapter 3
Warnings and Cautions ........... 4
3.1 Warnings ....................4
3.2 Cautions.....................5
Chapter 4
Indications and Contraindications 5
4.1 Indications ..................5
4.2 Contraindications............6
Chapter 5
Directions for Use..................6
5.1 Functional Controls ..........7
5.2 First Use .....................8
5.3 Charging the Device .........8
5.4 Applying the ACTitouch
System ......................9
5.5 Switching On the ACTitouch
System in Sustained
Compression Mode .........12
5.6 Muted Operation in Sustained
Compression Mode .........13
5.7 Intermittent Pneumatic
Compression Mode .........13
5.8 Switching O the ACTitouch
System .....................15
5.9 Removing the ACTitouch
System .....................16
Chapter 6
Wound Dressings .................16
Chapter 7
Cleaning, Care and Maintenance .17
7.1 Cleaning and Disinfecting...17
7.2 Storage and Handling.......19
7.3 Maintenance and Service ...19
7.4 Disposal ....................19
Chapter 8
Troubleshooting Guide ...........20
8.1 Limited Warranty for
Home Use ..................23
8.2 Obtaining Replacement
Products and Service........24
8.3 Limited Warranty and
Service for Facility Use ......24
8.4 Return Policy ...............24
8.5 Patents .....................24
8.6 Product Development and
Quality Improvement .......24
Chapter 9
Technical Information ............25
9.1 Symbols ....................26
9.2 Device Label................26
9.3 Electromagnetic
Interference ................28

1Customer Service Toll-Free: 866.435.3948
Before rst use, ensure that the following ACTitouch® System components are
accessible:
Compression Sleeve
Power
Adapter/Charger
Control Unit
Undersocks
(Three [3] socks
included)
User Guide
(Not shown)
Component List
CHAPTER 1

2
Product Description
CHAPTER 2
The ACTitouch System applies pneumatic compression to the lower leg, ankle, and
foot. It consists of four (4) main parts:
1. The Compression Sleeve consists of four (4) chambers that inate with air to
apply pressure to the leg. Its simple wrap-around design with hook and loop
fasteners means the Compression Sleeve can be tted to many dierently
shaped legs and can be applied and removed with ease.
2. The control unit ts into the Compression Sleeve during device use. It monitors
and adjusts the air pressure to ensure the correct level of compression is
applied to the leg.
3. The Undersock is designed to draw perspiration and moisture away from the
skin and has padding in key areas to provide additional comfort.
4. The Power Adapter/Charger is used to power the device directly or to charge
the battery for ambulatory use.
The device has two (2) modes of operation: Sustained Compression Mode and
Intermittent Pneumatic Compression Mode.
2.1 Sustained Compression Mode
In this mode, the
device provides
sustained, graduated
pneumatic
compression to
the leg at preset
pressures, while
powered by its
own rechargeable
battery. When it is
rst switched on,
the device gradually
inates, starting
at the foot and working up toward the knee. Each chamber will stop inating
Pressure Changes During
Sustained Compression Mode
Pressure Changes During
Intermittent Pneumatic Compression Mode
Chamber 1 Chamber 2 Chamber 3 Chamber 4
Chamber 1 Chamber 2 Chamber 3 Chamber 4
45
40
35
30
25
20
15
10
5
0
55
50
45
40
35
30
25
20
15
10
5
0
Time
Time
Pressure (mmHg)
Pressure (mmHg)

3Customer Service Toll-Free: 866.435.3948
when the correct pressures are achieved and will hold these pressures until the
device is turned o. Every half hour, the pressures are automatically checked and
readjusted, if necessary. The patient may hear the pump running for a few seconds
while the pressure is being checked. In this mode, the patient is free to move
around and carry out normal activities (See Chapter 3 Warnings and Cautions).
When operating in Sustained Compression Mode, and absolute quiet is necessary
(e.g., at the theater), a MUTE or PAUSE button can be used to pause the pump
(See Section 5.6 Muted Operation in Sustained Compression Mode). While muted or
paused, the device will remain inated to apply pressure to the leg but will no
longer adjust the pressure.
IMPORTANT: The device will automatically reset to normal operation after two (2)
hours of muted or paused use.
2.2 Intermittent Pneumatic Compression Mode
When in Intermittent
Pneumatic Compression
Mode, the device will
perform cyclic ination/
deation sequences
to preset gradient
pressures. To operate in
this mode, the control
unit requires power
from the Power Adapter/
Charger. When the
device is rst plugged
in and switched on, it
will initially inate to
a low pressure in each
chamber. Once the starting pressure is reached, each chamber will inate in
sequence, starting at the foot and working up toward the knee until all of the
chambers reach the intended pressure levels. All four (4) chambers will then
deate to the low pressure level. This cycle of ination and deation will continue
until the device is either unplugged from the Power Adapter/Charger or after
two (2) hours of use. When the device is operating in Intermittent Pneumatic
Compression Mode, the patient should remain lying down, reclined, or seated
with leg elevated.
Pressure Changes During
Sustained Compression Mode
Pressure Changes During
Intermittent Pneumatic Compression Mode
Chamber 1 Chamber 2 Chamber 3 Chamber 4
Chamber 1 Chamber 2 Chamber 3 Chamber 4
45
40
35
30
25
20
15
10
5
0
55
50
45
40
35
30
25
20
15
10
5
0
Time
Time
Pressure (mmHg)
Pressure (mmHg)

4
3.1 Warnings
• Please read all of the information provided before use and ensure that all
instructions are followed.
• Do not use the device on patients with medical conditions where an increase
in venous and lymphatic return is undesirable.
• Electrical equipment may be hazardous if misused. Do not open or take apart
the ACTitouch control unit for any reason or the warranty will be voided. There
are no customer serviceable parts in this device.
• Prior to use, the patient should be fully assessed by a healthcare professional
for treatment suitability, trained on the use of the device, and advised on
optimal wear time in each mode.
• Failure to wear the device as recommended, even for short periods, may delay
ulcer healing or may negatively impact treatment outcomes.
• Use the ACTitouch control unit or ACTitouch Compression Sleeve only with the
ACTitouch Undersock and Power Adapter/Charger. Do not use the ACTitouch
System while wearing other compression products.
• Treatment should be stopped if additional pain, tingling or numbness of the
limb occurs during, or as a result of treatment.
• The Undersock should not be placed in direct contact with an open wound.
It is recommended that this device be used in conjunction with an appropriate
absorptive moisture retentive wound dressing, applied before the ACTitouch
System.
• Caution should be taken when using the ACTitouch System on fragile skin.
• Do not operate motor vehicles or other machinery while wearing the
ACTitouch System. Consult with your healthcare provider about compression
options when not wearing the ACTitouch System.
• Ensure the electrical supply to the device is switched o by disconnecting it
from the Power Adapter/Charger before cleaning or disinfecting.
• The ACTitouch System should be removed before bathing or showering.
Reapply the device immediately afterward, ensuring the skin is dried prior to
application.
• Do not walk with the Power Adapter/Charger attached to the device.
Warnings and Cautions
CHAPTER 3

5Customer Service Toll-Free: 866.435.3948
3.2 Cautions
• Regularly check the status indicator located at the top of the control unit while
using ACTitouch. The green light on the control unit indicates the control unit
is charged and on. A ashing red status light (and periodic audible alarm)
indicates that battery power is low. No light indicates the power is o.
• Ensure that the device is clean and dry prior to storage.
• Do not immerse the ACTitouch System in water, or spill liquid on the control
unit. The device is not waterproof, and exposure to liquid may damage the
control unit or Compression Sleeve. If the device becomes soaked with uid,
discontinue use of the device.
• Do not allow the Compression Sleeve to come into contact with sharp objects.
• Do not expose the Undersock, Compression Sleeve or control unit to excessive
heat or open ames, such as cigarettes, portable heaters, etc.
Indications and Contraindications
CHAPTER 4
Rx Only
U.S. Federal law restricts this device to sale by, or on the order of, a licensed
healthcare professional.
4.1 Indications
The ACTitouch System provides graduated compression in both sustained and
intermittent settings for use in:
• Enhancing venous return;
• Reducing venous leg ulcer healing time;
• Treatment and promotion of healing of stasis dermatitis and venous stasis
ulcers;
• Treatment of chronic venous insuciency;
• Reducing edema due to venous stasis;
• Treatment of lymphedema.

6
4.2 Contraindications
The ACTitouch System is contraindicated if the patient has:
• An Ankle Brachial Pressure Index of less than 0.6 or ankle systolic pressure less
than 60 mmHg;
• Diagnosed or suspected acute Deep Vein Thrombosis (DVT) or pulmonary
embolism;
• Pulmonary edema;
• Leg gangrene;
• Acute thrombophlebitis;
• Decompensated/Congestive Cardiac Failure;
• Severe arteriosclerosis or other ischemic vascular disease;
• Diabetes in association with peripheral arterial disease;
• Acute infections of the skin such as cellulitis;
• Any lower limb malignancy.
Directions for Use
CHAPTER 5
• The ACTitouch System should be worn as recommended and prescribed by the
physician. The usual prescribed duration of use will range from 10 to 14 hours
per day, including both Sustained Compression and Intermittent Pneumatic
Compression Modes.
• The device should be applied immediately upon waking and worn throughout
the day. The ACTitouch System should be removed for bathing or showering,
and when driving or operating machinery. Reapply the device immediately
after these activities.
• The device should be removed just prior to going to bed and recharged (See
Section 5.3 Charging the Device). Consult with your healthcare provider about
other compression options during sleep.
IMPORTANT: Failure to wear the device as recommended, even for short periods,
may delay ulcer healing or may negatively impact treatment outcomes.

7Customer Service Toll-Free: 866.435.3948
5.1 Functional Controls
ACTitouch Control Unit
Status indicator
ON/OFF button
MUTE or PAUSE button
Liquid crystal display (LCD)
Charging port
ACTitouch Compression Sleeve (Outer Face Up)
Control unit
release handle
Control unit
release buttons
Control unit housing
Leg section
Loop fasteners
Foot section

8
5.2 First Use
Remove all device components from the packaging and fully charge the device as
indicated in Section 5.3 Charging the Device.
5.3 Charging the Device
Before each daily use, the ACTitouch System should be fully charged. It is
recommended that the device be charged every night for a minimum of four (4)
hours. The control unit should remain inserted in the Compression Sleeve while
charging.
• Ensure that the Power Adapter/Charger is connected to a working AC power
outlet. A green light will illuminate on the Power Adapter/Charger when it is
correctly connected.
• Plug the supplied Power Adapter/Charger into the charging port on the control
unit. If this is done correctly, and the battery was low, the control unit status
indicator will ash red until fully charged. Otherwise, the green status indicator
on the control unit will illuminate. Charge the unit for a minimum of four (4)
hours, even if the status indicator on the control unit is showing green
• The status indicator ashes red when the battery charge is low. Immediate
charging is required. The normal battery life between charges is
sixteen (16) hours.
ACTitouch Compression Sleeve (Outer Face Down)
Chamber 4 (upper calf)
Chamber 3 (mid calf)
Chamber 2
(ankle/gaiter)
Chamber 1 (foot)
Strap 2 (ankle strap)
Hook fasteners
Strap 1
Strap 3

9Customer Service Toll-Free: 866.435.3948
• The device will be fully charged after four (4) hours. Nightly charging is
recommended.
If the control unit is stored unused for prolonged periods of time, the control unit
should be fully charged at least once every six (6) months. This will ensure that a
good battery life is maintained.
IMPORTANT: To ensure an adequate supply of power while wearing the device,
please ensure that you charge the device at the end of each day. Charge whether
the status indicator is showing green or ashing red.
Use only the Power Adapter/Charger provided with your ACTitouch System for
charging the control unit and for Intermittent Pneumatic Compression Mode
operation.
The batteries are not user replaceable.
5.4 Applying the ACTitouch System
CAUTION: The ACTitouch Undersock should not be placed in direct contact with
an open wound. It is recommended that this device be used in conjunction with an
appropriate wound dressing before the device is applied (See Chapter 6 Wound
Dressings).
IMPORTANT: Patients are advised to apply the device before putting on clothing
over the leg and foot.
5.4.1 Applying the ACTitouch Undersock
For correct positioning of the Undersock, ensure that the word“ACTitouch” is
positioned on the top of the foot and the padded areas are positioned over the
shin and around the heel and ankle.
Apply the Undersock over the foot, and then pull it up to just
below the knee, taking care not to displace any wound dressing.

10
5.4.2 Inserting the Control Unit into the Compression Sleeve
Slide the control unit into its housing on the Compression Sleeve
until a click is felt and heard; the control unit is then secured correctly
within the sleeve.
Verify the control unit is correctly assembled by checking to see if the
blue markings are visible on the front of the control unit. If they are
visible, the control unit is not fully secure.
Incorrect placement
Correct placement
IMPORTANT: For correct functioning of the device, ensure that the control unit is
correctly inserted in the Compression Sleeve.
The patient should leave the control unit inserted into the Compression Sleeve at
all times. The battery can be charged without removing the control unit from the
Compression Sleeve.
5.4.3 Applying the Compression Sleeve
Place the Compression Sleeve on the oor, outer face
downward so that the chambers can be seen, with strap 2
(ankle strap) pointing toward the wearer, regardless of whether
the Compression Sleeve is to be applied to the right or left leg.
Place the arch of the foot over chamber 1 (marked with an
arrow on the Compression Sleeve) with the toes pointing in
the direction of the arrow.
Strap 1
Strap 2 (ankle strap)
Strap 3

11 Customer Service Toll-Free: 866.435.3948
Wrap strap 3 over the top of the foot and secure in place over straps 1 and 2.
The correctly applied foot section will appear as shown.
Once the foot section is fastened, lift the leg section of the Compression
Sleeve and drape over the leg with the control unit and“ACTitouch” logo
positioned over the shin.
Wrap strap 1 over the top of the foot and secure in place by wrapping
strap 2 (ankle strap) around the ankle and placing over strap 1.
Strap 1
Strap 2 (ankle strap)
Strap 3
Strap 3
Wrap the loop fasteners around the back of the calf.

12
Fix the loop fasteners securely in place with the hook fasteners.
Ensure that fasteners are adjusted to give a close t between the
Compression Sleeve and the leg and foot.
The correctly applied ACTitouch System will appear as shown.
WARNING: When applied, the top of the Compression Sleeve should be at least 2.5cm
below the crease of the knee when seated.
IMPORTANT: Always ensure that the Compression Sleeve is applied in the correct
position with the control unit on the front of the leg over the shin.
Applying the sleeve too loosely may result in the unit switching o.
5.5 Switching On the ACTitouch System in Sustained
Compression Mode
IMPORTANT: If footwear is to be worn during the treatment session, it is advisable
for the wearer to put on footwear prior to switching on the ACTitouch System.
Do not switch on the device in Sustained Compression Mode unless it is applied to
the leg.
• Ensure that the control unit is correctly inserted in the Compression Sleeve,
that the Compression Sleeve is correctly applied to the leg, and that the Power
Adapter/Charger is not connected.
• While seated, press and hold the ON/OFF button until the status indicator
illuminates (approximately two [2] seconds). The ON/OFF button can then be
released.

13 Customer Service Toll-Free: 866.435.3948
• The Compression Sleeve will now inate. It may take up to ve (5) minutes to
completely inate the Compression Sleeve. Remain seated during ination. To
ensure a better t, pull up and support the Compression Sleeve in place while
the chambers inate.
• The control unit is programmed to inate the chambers of the Compression
Sleeve to preset pressures. When the correct pressures are reached, the control
unit will stop pumping.
• When the Compression Sleeve is fully inated, the patient may stand up and
resume normal activities. (See Chapter 3 Warnings and Cautions.)
• The MUTE button may be used in Sustained Compression Mode once the
Compression Sleeve is fully inated. (See Section 5.6 Muted Operation in
Sustained Compression Mode for details.)
5.6 Muted Operation in Sustained Compression Mode
• To activate muted or paused operation during Sustained Compression Mode,
press the MUTE button and hold for at least two (2) seconds. Upon release of
the MUTE button, the control unit will make a subtle beep sound.
IMPORTANT: While muted, the device will remain inated to apply pressure to the
leg but will no longer adjust the pressure.
• To deactivate muted operation, press the MUTE button again (for at least two
[2] seconds). Upon release of the MUTE button, the control unit will make a
subtle beep sound. The pump will now restart and, if necessary, readjust all
chambers back to the correct pressures.
• If muted operation is not manually deactivated, then the device will
automatically switch back to Sustained Compression Mode operation after
two (2) hours.
5.7 Intermittent Pneumatic Compression Mode
In Intermittent Pneumatic Compression Mode, the device will operate a cyclic
pulsed ination/deation sequence until either it is unplugged from the Power
Adapter/Charger, or two (2) hours have elapsed, at which point the device will
switch back to Sustained Compression Mode operation.

14
It is recommended that the Intermittent Pneumatic Compression Mode be
used for at least two (2) hours per day. When using in Intermittent Pneumatic
Compression Mode, the user should be either seated or lying down with the foot
elevated and ankle relaxed; not standing. This can be for:
• One (1) session of two (2) hours OR
• Two (2) one-hour (1-hour) sessions.
• Any session should be a minimum of 30 minutes.
It is recommended that the Intermittent Pneumatic Compression Mode be used
late in the user’s day when swelling would be the greatest, and when the user is
less active and can sit, recline, or lie down.
To operate in Intermittent Pneumatic Compression Mode for longer than two
(2) hours in succession, the Intermittent Pneumatic Compression Mode may
be re-activated after the device automatically switches back into Sustained
Compression Mode. For advice on optimal wear time in Intermittent Pneumatic
Compression Mode, please consult a healthcare professional. Failure to use the
device as recommended may delay ulcer healing or may negatively impact
treatment outcomes.
CAUTION: Do not walk while the device is operating in Intermittent Pneumatic
Compression Mode.
5.7.1 To Activate Intermittent Pneumatic Compression Mode
from Sustained Compression Mode Operation
• Plug the supplied Power Adapter/Charger into the charging port on the
control unit.
• Ensure that the Power Adapter/Charger is connected to an AC power outlet.
A green light will illuminate on the Power Adapter/Charger if it is correctly
connected to the power supply.
• Press the ON/OFF button for at least two (2) seconds. Upon release of the ON/
OFF button, Intermittent Pneumatic Compression Mode will be activated and
the pump will start.
IMPORTANT: Do not switch the device into Intermittent Pneumatic Compression
Mode unless the Compression Sleeve is applied to the leg.

15 Customer Service Toll-Free: 866.435.3948
5.7.2 To Activate Intermittent Pneumatic Compression Mode
from O:
• Apply the Compression Sleeve (See Section 5.4.3 Applying the Compression
Sleeve).
• Plug the supplied Power Adapter/Charger into the charging port on the
control unit.
• Ensure that the Power Adapter/Charger is connected to a working AC power
outlet. A green light will illuminate on the Power Adapter/Charger if it is
correctly connected to the power supply.
• Press the ON/OFF button for at least two (2) seconds. Upon release of the ON/
OFF button Intermittent Pneumatic Compression Mode will be activated and
the pump will start.
5.8 Switching O the ACTitouch System
• Ensure that the Power Adapter/Charger is not attached to the charging port.
• Press and hold the ON/OFF button for at least two (2) seconds. On release of
the ON/OFF button, the device will now deate all chambers and automatically
switch itself o.
IMPORTANT: The ACTitouch System device may automatically switch o on rare
occasions if prolonged high pressure is detected by the device. This could occur
if high pressure is applied externally to the sleeve. This is a safety feature of the
device, which may be restarted in the normal way (See Section 5.5 Switching On
the ACTitouch System in Sustained Compression Mode). If the device switches o
repeatedly, refer to Chapter 8 Troubleshooting Guide.

16
5.9 Removing the ACTitouch System
• To remove the device, reverse the procedure outlined in Section 5.4 Applying
the ACTitouch System.
• If required, clean the Compression Sleeve according to the cleaning
instructions in Chapter 7 Cleaning, Care and Maintenance.
• Wash the Undersock according to the cleaning instructions in Chapter 7
Cleaning, Care and Maintenance.
IMPORTANT: The patient should leave the control unit inserted into the
Compression Sleeve at all times.
The battery can be charged without removing the control unit from the
Compression Sleeve.
Wound Dressings
CHAPTER 6
The ACTitouch System should be used in conjunction with an appropriate wound
dressing as recommended by your clinician. Apply the dressing to the wound
before applying the ACTitouch Undersock.
Please follow the dressing manufacturer’s instructions for use. Appropriate tape or
a light retention stocking may aid dressing retention.
The primary dressing over the ulcer should be changed when clinically indicated.
Typically dressings will require changing when they are moistened, as can occur
if your wound is leaking any uid or if the dressing becomes wet after bathing or
showering.
Remove the ACTitouch System prior to showering. If you do not wish to change
the dressing when showering, cover the dressing with a waterproof outer layer.

17 Customer Service Toll-Free: 866.435.3948
Cleaning, Care and Maintenance
CHAPTER 7
Please refer to Chapter 3 Warnings and Cautions. Switch o and disconnect the
Power Adapter/Charger before cleaning or disinfecting.
7.1 Cleaning and Disinfecting
7.1.1 Cleaning the ACTitouch Undersock
IMPORTANT: The ACTitouch Undersock is intended for single patient use only.
It is recommended that the ACTitouch Undersock be replaced after a maximum of
60 washes. To purchase additional socks please contact
Customer Service at 866.435.3948.
Machine wash hot on a gentle cycle
Air dry or tumble dry on a low-temperature setting
Do not iron
Do not use chlorine-based bleach
Do not dry clean

18
7.1.2 Cleaning and Disinfecting the ACTitouch Compression
Sleeve
WARNING: Switch o and disconnect the Power Adapter/Charger before inspecting,
cleaning or disinfecting. Failure to comply could result in electric shock.
To clean, wipe down with a soft cloth dampened with mild soap and water. Do not
immerse in uids. Air dry thoroughly.
Do not machine wash
Do not tumble dry
Do not iron
Do not dry clean
DisCide® ULTRA Spray Disinfectant has been demonstrated to eectively
disinfect the ACTitouch System. Use DisCide ULTRA Spray or similar disinfectant
compliant with OSHA’s Bloodborne Pathogen Standard (29 CFR 1910.1030) and/
or registered with EPA. To disinfect the ACTitouch Compression Sleeve between
patient use, or if there are visible biological contaminants or visible stains, the
following steps are recommended:
1. Clean any visible blood or body uids from the surface of the sleeve.
2. Thoroughly wet surface with DisCide ULTRA Disinfecting Spray.
3. Allow surfaces to remain wet for one minute and then allow to air dry.
Do not clean or disinfect with household detergents, abrasive cleaners,
scourers, degreasers, solvents, bleach or phenol-based agents, such as
trichlorophenol (TCP).
7.1.3 Cleaning and Disinfecting the ACTitouch Control Unit
WARNING: Switch o and disconnect the Power Adapter/Charger before inspecting,
cleaning or disinfecting. Failure to comply could result in electric shock.
To clean, wipe down with a soft cloth dampened with mild soap and
water. Do not immerse in uids. Air dry thoroughly.