Avacen 100 User manual

171208
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, Inc.
Protected by one or more of the following U.S. patents: 8,679,170; 9,066,781; 9,192,509;
9,687,385; international equivalents. Other patents pending.
AVACEN Medical
9835 Carroll Centre Rd. #104
San Diego, CA 92126
(888) 4-AVACEN (888-428-2236)
www.AVACEN.com
THE QUICK START GUIDE IS ON BACK COVER
All manuals and user guides at all-guides.com
all-guides.com

171208
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 100 Dia
g
ram
Vacuum Chamber
Pins
Sanitary Mitt
Metal
Heatpad
All manuals and user guides at all-guides.com

171208
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 100 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 100 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 100 Heatpad is too hot ................................................................................. 14
N. The Display Panel Power LED does not illuminate after pushing the ON Button ............. 14
O. Checking the inflatable cuff for leaks ................................................................................ 14
All manuals and user guides at all-guides.com

171208
P. Excessive swelling of the hand ........................................................................................... 15
Q. Red or purple spots on the hand ........................................................................................ 15
R. Hand itches or tingles ......................................................................................................... 15
S. My hand is reddish-colored like it has been in hot water .................................................. 15
T. Sweating when using the AVACEN 100 .............................................................................. 15
U. 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
24. EC DECLARATION OF CONFORMITY ................................................................................... 23
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions and Immunity.......... 24
All manuals and user guides at all-guides.com

171208 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 100 MUST be used with the supplied hand mitts. Extra hand mitts can be purchased at:
https://avacen.com/parts/
2. UNPACKING THE UNIT
The shipping box contains the AVACEN 100 unit, power cord, power supply, mitts, spare Vacuum
Chamber "pins", and this user guide. Lift the top shipping foam piece out of the box. Then lift
the AVACEN 100 out of the box with two hands. Keep the shipping box and foam in case the
AVACEN 100 needs to be returned.
3. NORMAL USE
The AVACEN 100 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 100 right away and report the problem to AVACEN Medical Customer
Service at (888) 4-AVACEN (888-428-2236) or send an email to: [e-mail]
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 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; the temporary relief of widespread pain
associated with fibromyalgia; muscular relaxation; and the temporary increase of
microcirculation.
5. CONTRA-INDICATIONS
Although there has been no issues reported, it is suggested that you contact a doctor before
using the AVACEN 100 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 100 on a hand that has open sores or
wounds.
All manuals and user guides at all-guides.com

2 AVACEN 100 User Guide 171208
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 100 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 100 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 100 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 100 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 [e-mail]
• If the unit does not turn off when the On/Off Button is pressed, unplug the unit.
• To remove your hand from the Vacuum Chamber at any time, release the air from the
inflatable cuff by pressing the Pressure Release Button on the underside of the Inflatable
Cuff.
• Although there have been no issues reported, consult your healthcare professional before
using the AVACEN 100 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.
All manuals and user guides at all-guides.com
all-guides.com

171208 AVACEN 100 User Guide 3
7. IMPORTANT SAFETY INFORMATION
• Read the entire AVACEN 100 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 100 in direct sunlight. The AVACEN 100 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 100 to be ineffective.
• The Power Supply Connector is the main power disconnect device for the AVACEN 100. 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
All manuals and user guides at all-guides.com

4
8.
Manuf
a
AVACE
N
9835 C
a
San Die
Phone:
web: A
V
Email:
C
9.
Sym
b
CONTA
C
a
cturer:
N
Medical
a
rroll Centr
go, CA 921
2
(888) 4-AV
A
V
ACEN.co
m
C
ustomerS
e
EXPLAN
A
b
ol
✔
▲▼
▂▅
▇
IP2
1
C
T INFO
R
e Rd. #104
2
6
A
CEN (888
-
m
e
rvice@AV
A
ATION
O
✔
◄►
▇
1
A
R
MATIO
N
-
428-2236)
A
CEN.com
O
F SYMB
O
Descrip
t
ON/OFF P
u
OK/Accep
t
Up / Dow
n
Low/Medi
Remove a
l
allow you
r
Caution:
R
Read Instr
Atmosph
e
Temperat
u
Humidity
R
Protectio
n
solid obje
c
Type BF A
p
Do Not Di
s
European
Identificat
Indicates
c
Complies
w
Equipmen
A
VACEN 1
0
N
O
LS
t
ion
u
shbutton
S
t
/Confirm/
S
n
/ Left / Ri
g
um/High T
e
l
l jewelry a
n
r
shirt slee
v
R
efer to Ins
t
uction Ma
n
e
ric Pressur
e
u
re Range
R
ange
n
rating for
c
ts larger t
h
p
plied Part
s
pose in Tr
a
Communit
y
ion of Man
c
ompliance
w
ith 47 CF
R
t
0
0 User G
u
Europ
MDSS
Shiffg
r
3017
5
S
witch
S
elect Pus
h
g
ht Functi
o
e
mperatur
e
n
d watch b
v
e to enter
i
t
ructions
n
ual
e
Range
ingress of
s
h
an 12.5 m
m
a
sh
y
Represen
ufacturer
to Europe
a
R
Part 18 f
o
u
ide
ean Repre
s
r
aben 41
5
Hannover
,
h
button Sw
i
o
n Select P
u
e
Settings
efore inser
i
nto the In
f
s
olid object
m
and vert
i
tative info
r
a
n Directiv
e
o
r Industria
l
s
entative:
,
Germany
i
tch
u
shbuttons
t
ing hand i
n
f
latable Cu
f
s and wate
i
cally dripp
i
r
mation
e
s
, Scientific,
n
the devic
e
f
f.
r: protecte
d
i
ng water
and Medi
c
171208
e
. Do not
d
against
c
al
All manuals and user guides at all-guides.com

171208
1
Conn
j
ack.
pane
cord
pow
e
Inter
have
the
A
plug
o
If th
e
1 ho
u
Turn
left s
i
welc
o
from
mem
Plea
s
(ring
s
be u
s
long
s
infla
t
cuff
W
It is
v
the
V
(resti
your
hand
Note
"Sta
n
dow
n
"Sta
n
OPTI
O
othe
r
100
c
usin
g
exte
n
allo
w
surfa
will r
u
reco
m
0. OPE
R
ect the P
o
The pow
e
l towards
t
end from
t
e
r source (
national
u
the corre
c
A
VACEN 1
0
o
n the co
r
e
device h
a
u
r before
t
on the A
V
i
de of the
o
me mess
a
Hand". T
h
brane. It
w
s
e Wait…"
s
, bracelet
s
ed for th
e
s
leeves, p
u
t
able cuff
c
W
ILL NOT
s
v
ery impor
t
V
acuum C
h
ng on the
hand pres
from the
V
: If more
n
dby" mo
d
n
. For det
a
n
dby Mod
e
O
NAL: W
h
r
time), th
e
c
an be adj
u
g
the devic
n
d the fee
t
w
s the use
r
ces witho
u
u
n from 1
0
m
mended
R
ATING I
N
o
wer Supp
l
e
r supply j
a
t
he lower
t
he powe
r
wall plug)
:
u
se: Care s
c
t cord an
d
0
0 is to be
r
d does no
a
s been st
o
t
urning it
o
V
ACEN 100
control p
a
a
ge and t
h
h
is is to pr
e
w
ill be foll
o
message.
W
s, watche
s
e
rapy. If y
o
u
ll the sle
e
c
ontacts b
a
s
eal again
s
t
ant that
t
h
amber w
h
Heatpad)
sure corr
e
V
acuum C
than one
p
d
e so that
t
a
ils on thi
s
e
Operati
o
h
ile the de
v
e
rear fee
t
u
sted to e
n
e. Turn th
e
t
; turn clo
c
r
's elbow t
o
u
t extrem
e
0
to 30 mi
to adjust
t
N
STRUC
T
l
y Connec
t
a
ck is loca
t
back corn
e
r
supply c
o
:
100-240
V
hould be
t
d
wall plu
g
used. Con
t
t fit.
o
red in a h
o
n.
by pressi
n
a
nel. The
D
h
en will di
s
e
vent da
m
o
wed by a
W
hile wai
t
s
) from th
e
o
u are we
a
e
ve up yo
u
a
re skin o
n
s
t a watch
t
he AVACE
h
en you tu
when the
e
ctly. If yo
hamber b
e
p
erson wil
t
he Heatp
a
s
operatin
g
o
n".
v
ice is wa
r
t
on the b
o
n
sure the
m
e
feet cou
c
kwise to
r
o
rest on
a
e
bending
nutes (us
e
t
he feet b
e
AVACEN
T
IONS (N
t
or into th
e
t
ed on th
e
e
r. Plug th
o
rd into th
e
V
~, 50-60
H
t
aken to e
n
g
for the c
o
tact AVAC
ot or cold
n
g the
b
D
isplay wi
l
s
play: "Re
m
m
age to th
e
"Warmin
g
t
ing, rem
o
e
hand an
d
a
ring a shi
r
u
r arm so t
n
your ar
m
or shirt sl
N 100 is p
rn the de
v
device is
t
u turn th
e
e
fore turn
l be using
a
d stays
w
g
mode, r
e
r
ming up (
o
o
ttom of t
h
most com
f
nter clock
w
r
etract th
e
a
table or
o
at the wri
s
e
r selecta
b
e
fore use.
100 User
G
ORMAL
M
e
power s
u
e
right sid
e
e AC pow
e
e
correct
H
z.
n
sure that
o
untry in
w
EN if the
w
area, allo
w
b
utton on
l
l show a
b
m
ove Jew
e
e
Mitt and
g
Heatpad
o
ve all jew
e
d
wrist tha
r
t or jacke
hat the
m
. The infl
a
eeve.
laced on
a
v
ice on. If
t
urned on,
e
device of
f
ing the d
e
the AVAC
w
arm in-be
t
e
fer to the
o
r at any
h
e AVACE
N
f
ort while
w
ise to
e
feet. Thi
s
o
ther sup
p
s
t. Sessio
n
b
le), so it i
s
G
uide
M
ODE O
u
pply
e
e
r
you
w
hich
w
all
w
it to rea
c
the
b
rief
e
lry
cuff
e
lry
t will
t with
a
table
a
level sur
f
your han
d
the onbo
a
f
(by mist
a
e
vice back
EN 100, t
h
t
ween us
e
section o
f
N
s
p
ort
n
s
s
W
PERATI
O
c
h normal
ace and y
o
d
is inside
t
a
rd comp
u
a
ke or on
p
o
n again.
h
e device
c
e
s and the
f
this man
u
Remo
v
Fr
o
W
armi
n
Plea
s
O
N)
room te
m
o
ur hand i
s
t
he vacuu
m
u
ter will n
o
p
urpose),
r
c
an be put
device do
e
u
al below
t
v
e Je
o
m Ha
n
g He
s
e Wa
m
perature
s
NOT insi
d
m
chambe
o
t measur
e
r
emove y
o
into
e
s not shu
t
itled
welr
y
nd
atpa
d
it...
5
for
d
e
r
e
o
ur
t
y
d
All manuals and user guides at all-guides.com

6
It will t
(depe
n
warm-
u
Thera
p
Place t
in the
b
right o
r
(1/2 in
After a
to Gre
e
right).
When
t
chang
e
SLOW
L
portio
n
four fi
n
Press
t
proper
IMPO
R
unit b
e
Sa
n
Mi
t
sh
o
ext
e
be
y
Infl
Cu
f
ake about
n
ding on t
h
u
p period,
p
y Hand".
h
erapy ha
b
ody of th
e
r
left thu
m
ch) in top
few seco
n
e
n ("A" on
t
he Heatp
a
e
to "Inser
t
L
Y insert t
n
of the H
e
n
gers resti
n
t
he ✔ but
t
ly positio
n
TANT: If y
o
e
fore turni
n
n
itary
t
t
o
uld
e
nd
y
ond
a
table
f
f
3 minute
s
h
e room t
e
the displ
a
nd in the
M
e
mitt an
d
m
b cavity
o
of mitt fr
e
n
ds, the R
e
the Contr
a
d has wa
r
t
Hand, Pr
e
he hand (
w
e
atpad sh
o
n
g on the
f
t
on to ind
i
n
ed on the
o
u accide
n
n
g it on a
g
A
s
for the d
e
mperatur
a
y will cha
n
M
itt. All 4
f
d
the thum
o
f the mitt
.
e
e when
p
e
ady light
w
ol Panel i
n
r
med up,
t
e
ss ✔ an
d
w
ith Mitt
a
o
uld be cu
p
f
ingertip
e
i
cate that
Metal He
a
n
tally pres
g
ain.
A
VACEN 1
0
evice to
w
e). Near t
n
ge to "Pl
a
f
ingers sh
o
b should
b
.
Importa
n
p
lacing ha
n
w
ill turn f
r
n
the figur
e
t
he Displa
y
d
a "beep"
a
pplied) in
p
ped in th
e
nd of the
your han
d
atpad.
s the On/
O
R
e
(f
F
(
0
0 User G
u
w
arm up
he end of
a
ce Mitt o
n
o
uld be pl
a
b
e placed
i
n
t: Leave
1
n
d inside.
r
om Oran
g
e
to the
y
Panel wi
l
will soun
d
to the Infl
a
e center o
Metal He
a
d
is inserte
O
ff button
e
ar Base
ingertip e
n
F
ront Bas
e
(
wrist end
)
u
ide
the
n
a
ced
i
n the
1
cm
g
e
l
l
d
.
a
table Cu
f
f the pal
m
a
tpad.
d into the
instea
O
n
Metal
n
d)
e
)
f
f. The rai
s
m
. To be m
o
Mitt and I
d, remov
e
Pla
c
n
The
r
Inse
r
Pr
e
Heatpad
D
s
ed, egg-s
h
o
st effecti
v
nflatable
C
e
your han
c
e Mi
r
apy
r
t H
a
e
ss
✔
Diagram
P
H
o
171208
h
aped
v
e, keep a
C
uff, and i
d from th
e
tt
Hand
a
nd
✔
osition
H
eel of Pal
m
n Front B
a
ll
s
e
m
a
se
All manuals and user guides at all-guides.com