Avacen PRO+ User manual

User Guide
Models AVACEN PRO+, AVACEN R3 PRO+
Caution: Please read the entire user guide with care prior to using the device.
AVACEN is a Registered Trademark of AVACEN Medical, Inc.
Protected by one or more of the following U.S. patents: 8,679,170; 9,066,781; 9,192,509;
9,687,385; 10,537,464; international equivalents. Other patents pending.
AVACEN Medical
2365 Camino Vida Roble, Suite C
Carlsbad, CA 92011
(888) 4-AVACEN (888-428-2236)
www.AVACEN.com
THE QUICK START GUIDE IS ON BACK COVER

Touchscreen/
Color Graphics Display (CGD)
Inflatable Cuff
Metal
Heat Pad
Pressure Holes
Power Supply Connector
Hand Positioning Tips: KEEP WRIST STRAIGHT AND IN THE CENTER OF THE CUFF!
POSITION WRIST
IN MIDDLE OF CUFF
PARALLEL
WITH CHAMBER
CORRECT
CORRECT
INCORRECT
INCORRECT
Sanitary Mitt
Metal
Heat Pad
Inflatable Cuff
POSITION WRIST
IN MIDDLE OF CUFF
PARALLEL
WITH CHAMBER
AVACEN PRO+ Device Diagram

Table of Contents
1. DESCRIPTION....................................................................................................................... 1
2. UNPACKING THE UNIT ........................................................................................................ 1
3. NORMAL USE ...................................................................................................................... 1
4. INDICATIONS FOR USE ........................................................................................................ 1
5. CONTRA-INDICATIONS........................................................................................................ 2
6. WARNINGS & PRECAUTIONS .............................................................................................. 2
7. IMPORTANT SAFETY INFORMATION................................................................................... 3
8. CONTACT INFORMATION.................................................................................................... 4
9. EXPLANATION OF SYMBOLS................................................................................................ 4
10. OPERATING INSTRUCTIONS (NORMAL MODE OPERATION) .............................................. 5
11. CUFF SEALING ..................................................................................................................... 6
12. HAND PRESSURE INDICATOR (HPI) ..................................................................................... 6
13. PAUSING A THERAPY SESSION ........................................................................................... 7
14. ADJUSTING THE THERAPY TIME......................................................................................... 7
15. ADJUSTING THE THERAPY TEMPERATURE.......................................................................... 7
16. END OF THERAPY ................................................................................................................ 7
17. STANDBY MODE OPERATION.............................................................................................. 7
18.GAME MODE OPERATION.................................................................................................. 8
19. TROUBLESHOOTING AND FAQS.......................................................................................... 9
A. How long should treatment last? ........................................................................................ 9
B. How important is the placement of my hand?.................................................................... 9
C. Is it necessary to wear the AVACEN Mitt?........................................................................... 9
D. Do I need a new a Mitt every time I have a treatment? ..................................................... 9
E. Do I need to purchase the Mitts from AVACEN?................................................................. 9
F. The AVACEN unit displays 'Did Not Seal' or 'Lost Vacuum Seal' message......................... 10
G. "Rest Palm On Heatpad" message..................................................................................... 10
H. "Calibration Failed" message............................................................................................. 11
I. "System Error" Message .................................................................................................... 11
J. There is noise while the AVACEN device is running .......................................................... 11
K. The inflatable cuff is too tight............................................................................................ 12
L. I keep getting a "Press Down" or "Lift Up" message ......................................................... 12
M. The AVACEN Heatpad is too hot (or too cool)................................................................... 12
N. The Heatpad seems "loose"............................................................................................... 12
O. The Display does not illuminate after plugging in power cord.......................................... 13
P. Checking the Inflatable Cuff for leaks................................................................................ 13
Q. Excessive swelling of the hand........................................................................................... 13

R. Red or purple spots on the hand ........................................................................................13
S. Hand itches or tingles .........................................................................................................13
T. My hand is reddish-colored like it has been in hot water..................................................13
U. Sweating when using the AVACEN .....................................................................................13
V. Discomfort in wrist or forearm during use.........................................................................13
20. SETTINGS...........................................................................................................................14
A. Language Selection .............................................................................................................14
B. Game Mode On/Off............................................................................................................14
C. Change Defaults..................................................................................................................14
D. Usage Statistics ...................................................................................................................15
E. Hardware Tests...................................................................................................................15
F. Last Failure..........................................................................................................................15
G. Factory Restore...................................................................................................................15
21. CLEANING...........................................................................................................................15
22. PERIODIC MAINTENANCE ..................................................................................................16
Replacing the Inflatable Cuff .....................................................................................................16

20220725 AVACEN PRO+, AVACEN R3 PRO+ User Guide 1
1. DESCRIPTION
Product model names - The AVACEN PRO+ family consists of two models: the AVACEN PRO+,
which is sold in the USA, and the AVACEN R3 PRO+, which is sold outside the USA. This User
Guide applies to both models. In the User Guide when the term "the AVACEN", "the AVACEN
device", or "the AVACEN system" is mentioned, the information applies to both models. When
the term "AVACEN PRO+" is mentioned, the information applies only to the AVACEN PRO+.
When the term "AVACEN R3 PRO+ " is used, the information applies only to the model AVACEN
R3 PRO+.
The AVACEN PRO+ is a Dry Heat Therapy FDA Class II Medical Device. The AVACEN R3 PRO+ is a
dry heat therapy device for household use. Both models consist of a control panel, metal heat
pad, and a Vacuum Chamber with an Inflatable Cuff. The vacuum pump and heat source are in
the base of the unit. For proper function and to maintain sanitary conditions, the AVACEN device
MUST be used with the supplied hand mitts. Extra hand mitts can be purchased by contacting
AVACEN at [email protected].
2. UNPACKING THE UNIT
The shipping box contains the AVACEN device, power cord, power supply, mitts, and this user
guide. Lift the top shipping foam piece out of the box. Then lift the AVACEN out of the box with
two hands. Keep the shipping box and foam in case the AVACEN needs to be returned. Be sure to
read the What to Expect flyer before the first use.
3. NORMAL USE
The AVACEN is designed to provide dry heat therapy. Treatment time and/or number of uses per
day can be increased based on professional recommendations or absence of response to
treatment. Proposed use is 20 minutes first thing in the morning using the LEFT hand (hint: "Left
is for day Light") and 20 minutes before bed using the RIGHT hand (hint: "Right is for Night"),
healthy hand condition permitting.
Any level of major discomfort (after lowering Heat setting first) is not normal. If this happens,
stop using the AVACEN right away and report the problem to AVACEN Medical Customer
Service at (888) 4-AVACEN (888-428-2236) or send an email to [email protected].
4. INDICATIONS FOR USE
United States - The AVACEN PRO+ is a heat therapy system indicated for: the temporary relief of
minor muscle pain, stiffness, and the temporary relief of joint pain associated with arthritis,
muscle spasms, minor strains and sprains. The device is also used for muscular relaxation, and
the temporary increase of local circulation where applied.
Outside the United States - The AVACEN R3 PRO+ is a heat therapy system indicated for: the
temporary relief of minor muscle pain, stiffness, and the temporary relief of joint pain associated
with muscle spasms, minor strains and sprains. The device is also used for muscular relaxation,
as well as the temporary increase of systemic microcirculation associated with increased healing,
general wellness and longevity.

2AVACEN PRO+, AVACEN R3 PRO+ User Guide 20220725
5. CONTRA-INDICATIONS
Although there have been no issues reported, it is suggested that you contact a doctor before
using the AVACEN if you are under 18 years of age, are pregnant, or have a temperature higher
than 99.5°F (37.5°C). Do not use the AVACEN on a hand that has open sores or wounds.
6. WARNINGS & PRECAUTIONS
WARNINGS are used to signal potential hazards which could lead to death or serious injury.
PRECAUTIONS are used to warn the reader of potential hazardous situations. If not avoided,
these hazards may result in minor or moderate injury to the user or patient or damage to the
device or other property.
Warnings
•This device IS NOT meant to provide ample heating where the internal body core
temperature is falling uncontrollably or is lower than 95F (35C). In these cases, GET
MEDICAL ATTENTION FAST!
•Making changes to this device is not allowed.
•Do not use the AVACEN with other devices or accessories except as described in this User
Guide.
•Choking hazard - contains small parts. Keep out of reach of children.
•Strangulation hazard - contains a long power cord that may cause strangulation if used
improperly. Keep out of reach of small children.
Precautions
•The following cautions are guidelines only and are not meant to replace a health care
professional’s advice. If any harmful effect occurs while using the product, stop use and
contact your health care professional.
•Use with care. May cause serious burns. Do not use on sensitive skin areas or in the
presence of poor circulation.
•The unattended use of the AVACEN by children or incapacitated persons may be
dangerous.
•Do not use with liniment, salve or ointments - may cause skin irritation.
•To prevent damage to the mitt and inflatable cuff, remove all jewelry (rings, bracelets,
watches) from the hand that will be used for therapy.
•Do not use the AVACEN on a hand that has open sores or wounds. Any level of major
discomfort (after lowering temperature first) is not normal.
•Metal implants - pay attention for signs of any uncomfortable heat buildup in the
treatment area. If this occurs, stop using the device.
•Stop using the AVACEN right away and report any major discomfort problems to AVACEN
Medical customer support at (888) 4-AVACEN (888-428-2236) or email AVACEN Medical
at [email protected]
•To remove your hand from the Vacuum Chamber at any time, unplug the unit. The air will
drain from the cuff as you slowly pull your hand out of the device.
•Although there have been no issues reported, consult your healthcare professional before
using the AVACEN if you have any of the following:.
•Malignancy (A term for diseases in which abnormal cells divide without control and
can invade nearby tissues) .
•Pregnancy.
•Chronically hot or swollen joint in the hand, fingers, or wrist.
•Circulatory diseases.
•Recent acute joint injury in the hand, fingers, or wrist.

20220725 AVACEN PRO+, AVACEN R3 PRO+ User Guide 3
7. IMPORTANT SAFETY INFORMATION
•Read the entire AVACEN device User Guide before using this device.
•For continued protection against risk of fire and shock, use the hand unit only with the
provided power supply, AVACEN part number 50-100000.
•Do not store the AVACEN device in direct sunlight. The AVACEN should be stored in a clean,
well-ventilated area at room temperature. Keep out of reach of small children and pets.
Optional carrying bags should be left open to allow ventilation.
•Do not use outdoors in the rain, snow, or under water. While the device is protected against
vertically dripping water, it is not water resistant, and should not be used in wet areas.
•Pressing too hard on the heat pad can cause the AVACEN to be ineffective.
•The Power Supply Connector is the main power disconnect device for the AVACEN device. If a
malfunction is suspected, unplug the power supply or remove the power input from the unit.
•This device complies with Part 18 of the FCC Rules, as well as international electromagnetic
compatibility requirements. Use is subject to these two conditions:.
1) This device may not cause harmful interference, and 2) This device must accept any
interference received, including interference that may cause undesired operation.
These limits are designed to provide reasonable protection against harmful interference in a
residential installation. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment causes problems with radio or TV reception, which
can be checked by turning the equipment off and on, you are encouraged to try to correct the
interference by one or more of the following measures:.
• Reorient the receiving antenna
• Relocate the system with respect to the receiver
• Move the system away from the receiver, and/or
• Plug the system into a different outlet so that the system and the receiver are on different
branch circuits.
Environmental Conditions
Temperature
Operating
50F (10°C) to 104F
(40°C)
Storage
32F (0°C) to 140F (60°C)
Relative
Humidity
Operating
30% to 75% rH
Storage
10% to 95% rH
Atmospheric
Pressure
Operating
700hPa to 1060hPa
Storage
500hPa to 1060hPa
AC Input Voltage
PRO+ - 240V~, 50-60Hz
Expected service life of equipment
and accessories
5 years

4AVACEN PRO+, AVACEN R3 PRO+ User Guide 20220725
8. CONTACT INFORMATION
Manufacturer:
AVACEN Medical
2365 Camino Vida Roble, Suite C
Carlsbad, CA 92011
Phone: (888) 4-AVACEN (888-428-2236)
Web: AVACEN.com
Email: [email protected]
9. EXPLANATION OF SYMBOLS
Symbol
Description
Home Icon
Mute and Unmute Icons for sound
Start/Advance/Resume and Pause Icons
Settings Icon
OK/Accept/Confirm Icon
Up / Down Adjust
Low/Medium/High Temperature Settings
Remove all jewelry and watch before inserting hand in the device.
Do not allow your shirt sleeve to enter into the Inflatable Cuff.
Caution: Refer to Instructions
Read Instruction Manual
Atmospheric Pressure Range
Temperature Range
Humidity Range
IP21
Protection rating for ingress of solid objects and water - protected
against solid objects larger than 12.5 mm and vertically dripping
water
Type BF Applied Part (model AVACEN PRO+ only)
Do Not Dispose in Trash
Identification of Manufacturer
Indicates compliance to European Directives
Complies with 47 CFR Part 18 for Industrial, Scientific, and Medical
Equipment

20220725 AVACEN PRO+, AVACEN R3 PRO+ User Guide 5
10. OPERATING INSTRUCTIONS (NORMAL MODE OPERATION)
Connect the Power Supply Connector into the power supply jack. The
power supply jack is located on the right side panel towards the lower
back corner. Plug the AC power cord end from the power supply cord
into the correct power source (wall plug) - PRO+-240V~, 50-60Hz.
International use: Care should be taken to ensure that you have the
correct cord and wall plug for the country in which the AVACEN R3
PRO+ is to be used. Contact AVACEN if the wall plug on the cord does not fit.
If the device has been stored in a hot or cold area, allow it to reach normal room temperature for
1 hour before turning it on.
Turn on the AVACEN device by inserting power plug. The display will show a welcome message.
Advancing beyond this welcome screen, you will see the Language selection. Please select the
desired language. After the language is selected, there will be disclaimer screens (only on first
power up). Please acknowledge that you meet the criteria by pressing “Yes” for these disclaimers.
Once completed, you will arrive at the “Please Wait, Warming up”screen. This message will
remain until the hand pad has reached 98.6° F.
When the hand pad reaches the predetermined standby
temperature, the home screen will be displayed. For best
results, the default temperature is “High,” and the default
therapy time is 20 minutes. These values may be adjusted by
pressing the up and down arrows for the subsequent settings.
Once you have selected your desired settings for therapy and advance to the next screen, you
will see a message to remove all jewelry. This is to prevent damage to the Mitt and cuff
membrane. Please remove all jewelry (rings, bracelets, watches) from the hand and wrist that
will be used for therapy. If you are wearing a shirt or jacket
with long sleeves, pull the sleeve up your arm so that the
inflatable cuff contacts bare skin on your arm. The inflatable
cuff WILL NOT seal against a watch or shirt sleeve.
The next screen will prompt you to place the AVACEN mitt on the hand you
plan to use for therapy. Place therapy hand in the Mitt. All 4 fingers should
be placed in the body of the mitt and the thumb should be placed in the right
or left thumb cavity of the mitt. Important - Leave 1 cm (1/2 inch) in top of
mitt free when placing hand inside, and ensure that the pressure holes are
facing up.
When ready, press the “Next” icon.

6AVACEN PRO+, AVACEN R3 PRO+ User Guide 20220725
The final preparation screen will prompt you to SLOWLY insert your hand (with Mitt applied) into
the Inflatable Cuff. The raised, egg-shaped portion of the heat pad should be cupped in the
center of the palm. To be most effective, keep all four fingers resting on the fingertip end of the
Metal heat pad. Please take care not to puncture or rip the flexible cuff, which is critical to the
operation of the device. When ready, press the “Next” icon, and therapy will begin!
It is very important that the AVACEN is placed on a level surface and your hand is NOT inside the
Vacuum Chamber when you power the device on. If your hand is inside the vacuum chamber
(resting on the heat pad) when the device is powered on, the onboard computer will not
measure your hand pressure correctly. If you power the device off (by mistake or on purpose),
remove your hand from the Vacuum Chamber before powering the device back on again.
11. CUFF SEALING
The "Pressurizing/Calibrating" message is displayed while
the vacuum motor runs. The bar along the bottom shows
the vacuum level; when the bar has fully changed color,
the full vacuum has been achieved.
IMPORTANT NOTE: The seal on the cuff may have become dislodged during shipping and
unpacking. If the seal is not properly in place, the Vacuum Chamber will not seal. Refer to the
"Troubleshooting" section of this User Guide for simple ways to correct this issue.
12. HAND PRESSURE INDICATOR (HPI)
When the unit seals properly, the top of the display will show the
remaining therapy time.
Too much hand pressure on the hand pad will set off an alarm
(beep) and display "Lift Up."
Too little hand pressure on the hand pad will set off an alarm
(beep) and display "Press Down."
Min Max
Sanitary
Mitt
should
extend
beyond
Inflatable
Cuff
Metal Heat pad Diagram
Rear Base
(fingertip end)
Front Base
(wrist end)
Position
Heel of Palm
on Front Base