Avacen 100 User manual

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User Guide
Model AVACEN 100
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, Ste. C
Carlsbad, CA 92011
(888) 4-AVACEN (888-428-2236)
www.AVACEN.com
THE QUICK START GUIDE IS ON BACK COVER

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OK/Accept/
Confirm/
Select ✔
Display Panel
ON/OFF Silicone Seal for
Vacuum Chamber
Inflatable Cuff
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 Diagram
Vacuum Chamber
Screws
Sanitary Mitt
Metal
Heatpad

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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

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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 Session Time ............................................................................................ 16
D. Default Therapy Session Temperature ............................................................................... 17
E. Display Error Messages ....................................................................................................... 17
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 ................................................................................................ 21

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AVACEN 100 User Guide 1
1. DESCRIPTION
The AVACEN 100 is a Dry Heat Therapy FDA Class II Medical Device. It consists 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: [e-mail]
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: Custome[email protected]
4. INDICATIONS FOR USE
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.
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.

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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 CustomerServic[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.

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AVACEN 100 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

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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: [e-mail]
9. EXPLANATION OF SYMBOLS
Symbol Description
ON/OFF Pushbutton Switch
✔
OK/Accept/Confirm/Select Pushbutton Switch
▲▼◄►
Up / Down / Left / Right Function Select Pushbuttons
▂▅▇
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 100 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

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AVACEN 100 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): 100-240V~, 50-60Hz.
International use: When traveling internationally, care
should be taken to ensure that you have the correct cord
and wall plug for the country in which the AVACEN 100 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 pressing the button on
the left side of the control panel. The Display will show a
brief welcome message and then will display: "Remove
Jewelry from Hand". This is to prevent damage to the Mitt
and cuff membrane. It will be followed by a "Warming
Heatpad Please Wait…" message. While waiting, 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.
It is very important that the AVACEN is placed on a level surface and your hand is NOT inside the
Vacuum Chamber when you turn the device on. If your hand is inside the vacuum chamber
(resting on the Heatpad) when the device is turned on, the onboard computer will not measure
your hand pressure correctly. If you turn the device off (by mistake or on purpose), remove your
hand from the Vacuum Chamber before turning the device back on again.
Note: If more than one person will be using the AVACEN, the device can be put into "Standby"
mode so that the Heatpad stays warm in-between uses and the device does not shut down. For
details on this operating mode, refer to the section of this manual below titled "Standby Mode
Operation".
OPTIONAL: While the device is warming up (or at any
other time), the rear feet on the bottom of the AVACEN
unit can be adjusted to ensure the most comfort while
using the device. Turn the feet counter clockwise to
extend the feet; turn clockwise to retract the feet. This
allows the user's elbow to rest on a table or other support
surfaces without extreme bending at the wrist. Sessions
will run from 10 to 30 minutes (user selectable), so it is
recommended to adjust the feet before use.
Remove Jewelry
From Hand
Warming Heatpad
Please Wait...

6 AVACEN 100, User Guide
210116
It will take about 3 minutes for the device to warm up
(depending on the room temperature). Near the end of the
warm-up period, the display will change to "Place Mitt on
Hand".
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.
After a few seconds, the Ready light will turn from Orange
to Green ("A" on the Control Panel in the figure to the
right).
When the Heatpad has warmed up, the Display Panel will
change to "Insert Hand, Press ✔ and a "beep" will sound.
SLOWLY insert the hand (with Mitt applied) into the Inflatable Cuff. The raised, egg-shaped
portion of the Heatpad 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 Heatpad.
Press the ✔ button to indicate that your hand is inserted into the Mitt and Inflatable Cuff, and is
properly positioned on the Metal Heatpad.
IMPORTANT: If you accidentally press the On/Off button instead, remove your hand from the
unit before turning it on again.
Place Mitt
On Hand
Insert Hand
Press ✔
Sanitary
Mitt
should
extend
beyond
Inflatable
Cuff
Metal Heatpad Diagram
Rear Base
(fingertip end)
Front Base
(wrist end)
Position
Heel of Palm
on Front Base