Avacen 100 User manual

200226
User Guide
Models AVACEN 100, AVACEN 100-E
THE QUICK START GUIDE IS ON BACK COVER
www.AVACEN.com
(888) 4-AVACEN (888-428-2236)
Carlsbad, CA 92011
2365 Camino Vida Roble #C
AVACEN Medical
9,687,385; 10,537,464; international equivalents. Other patents pending.
Protected by one or more of the following U.S. patents: 8,679,170; 9,066,781; 9,192,509;
AVACEN is a Registered Trademark of AVACEN Medical, Inc.
Caution: Please read the entire user guide with care prior to using the device.

200226
OK/Accept/
Confirm/
Select ✔
Display Panel
ON/OFF Silicone Seal for
Vacuum Chamber
Inflatable Cuf
f
Metal
Heatpad
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
Power
Plug
Up
Down
Left Right
AVACEN Device Dia
g
ram
Vacuum Chamber
Screws
Sanitary Mitt
Metal
Heatpad

200226
Table of Contents
1. DESCRIPTION ....................................................................................................................... 1
2. UNPACKING THE UNIT ........................................................................................................ 1
3. NORMAL USE ...................................................................................................................... 1
4. INDICATIONS FOR USE ........................................................................................................ 1
5. CONTRA-INDICATIONS ........................................................................................................ 1
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 ..................................................................................................................... 7
12. HAND PRESSURE INDICATOR (HPI) .................................................................................... 7
13. PAUSING A THERAPY SESSION ............................................................................................ 8
14. ADJUSTING THE THERAPY TIME .......................................................................................... 8
15. ADJUSTING THE THERAPY TEMPERATURE .......................................................................... 8
16. END OF THERAPY ................................................................................................................ 8
17. POWERING DOWN .............................................................................................................. 8
18. STANDBY MODE OPERATION .............................................................................................. 9
19. GAME MODE OPERATION ................................................................................................... 9
20. TROUBLESHOOTING AND FAQ .......................................................................................... 11
A. How long should treatment last? ...................................................................................... 11
B. How important is the placement of my hand? .................................................................. 11
C. Is it necessary to wear the AVACEN Mitt? ......................................................................... 11
D. Do I need a new a Mitt every time I have a treatment? ................................................... 11
E. Do I need to purchase the Mitts from AVACEN? ............................................................... 11
F. The AVACEN unit powers down while the 'Sealing Cuff' message or 'Lost Vacuum Seal'
message is displayed ......................................................................................................... 12
G. "Rest Palm On Heatpad" message ..................................................................................... 12
H. "Calibration Failed" message ............................................................................................. 13
I. "System Error" Message .................................................................................................... 13
J. There is noise while the AVACEN device is running .......................................................... 13
K. The inflatable cuff is too tight ............................................................................................ 13
L. I keep getting a "Push Hand Down Slightly" or "Lift Hand Slightly" message ................... 14
M. The AVACEN Heatpad is too hot (or too cool) ................................................................... 14
N. The Heatpad seems "loose" ............................................................................................... 14
O. The Display Panel Power LED does not illuminate after pushing the ON Button ............. 15

200226
P. Checking the inflatable cuff for leaks ................................................................................. 15
Q. Excessive swelling of the hand ........................................................................................... 15
R. Red or purple spots on the hand ........................................................................................ 15
S. Hand itches or tingles ......................................................................................................... 15
T. My hand is reddish-colored like it has been in hot water .................................................. 15
U. Sweating when using the AVACEN ..................................................................................... 15
V. Discomfort in wrist or forearm during use ......................................................................... 15
21. USER SETTINGS .................................................................................................................. 16
A. Language Selection ............................................................................................................. 16
B. Beep Tone Style .................................................................................................................. 16
C. Default Therapy Time ......................................................................................................... 1 6
D. Default Therapy Temperature ............................................................................................ 17
E. Display Error Messages ....................................................................................................... 1 7
F. Measure Hand Pad Force .................................................................................................... 17
G. Run Self-Sealing Test ........................................................................................................... 17
22. CLEANING ........................................................................................................................... 19
23. PERIODIC MAINTENANCE .................................................................................................. 19
Removing the Vacuum Chamber ............................................................................................... 19
Removing the Seal ..................................................................................................................... 20
Installing the Seal ....................................................................................................................... 20
Installing the Vacuum Chamber ................................................................................................ 2 1

200226 AVACEN 100, AVACEN 100-E User Guide 1
1. DESCRIPTION
Product model names: The AVACEN 100 family consists of two models: the AVACEN 100, which is
sold in the USA, and the AVACEN 100-E, 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 100" is mentioned, the information applies only to the AVACEN 100. When the term
"AVACEN 100-E" is used, the information applies only to the model AVACEN 100-E.
The AVACEN 100 is a Dry Heat Therapy FDA Class II Medical Device. The AVACEN 100-E is a dry
heat therapy device for household use. Both models consist of a control panel, metal Heatpad,
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: 15 minutes first thing in the morning using the LEFT hand (hint: "Left
is for day Light") and 15 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: C[email protected]
4. INDICATIONS FOR USE
United States: The AVACEN 100 is a heat therapy system indicated for the temporary relief of
minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with
arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary
increase of local circulation where applied.
Outside the United States: The AVACEN 100-E is a heat therapy system indicated for the
temporary relief of minor muscle and joint pain and stiffness, the temporary relief of joint pain
associated with muscle spasms, minor strains and sprains; muscular relaxation; and the
temporary increase of systemic microcirculation associated with increased healing, general
wellness and longevity.
5. CONTRA-INDICATIONS
Although there has 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.

2 AVACEN 100, AVACEN 100-E User Guide 200226
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 over 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, turn the unit Off. During
the power down process the air will be automatically drained from the cuff so that your
hand can be removed easily.
• If the unit does not turn off when the On/Off Button is pressed, 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.

200226 AVACEN 100, AVACEN 100-E 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
the unit does not turn off when the On/Off Button is pressed or 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. 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.
• 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 700 to 1060hPa
Storage 500 to 1060hPa
AC Input Voltage 100-240V~, 50-60Hz
Expected service life of equipment and
accessories 5 years

4
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a
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✔
Diagram
P
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