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