Ethicon Gynecare Thermachoice II User manual
THERMACHOICEIG
Uterine
Balloon
Therapy
ThermaChoice
II
UBT
System
Operating
Manual
GYNECARE
Table
of
Contents
Device
Indicationg
Adverse
Other
Clinical
Patient
Patient
Description
Events
Potential
Trial
Selection
Counseling
Pretreatment
Directions
for
sense
Adverse
Preparation
USe
Effects
of
Patient
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11
Catheter
Pressure
Treatment
Post-Treatment
Operating
Error
Warranty
Servicing/
Ordering
Specifications
Environmental
Parameters/
Messages.....
Equipment
Information
(Controller & Umbilical
Conditions
Electromagnetic
Maintenance
Calibration
Fuse
Replacemen
Cleaning:
Disinfecton:
AS
Priming
Titration
emm.
Interference
Controller
....
Alarm
sense
Disposal
..
.
System
Umbilical
AA
and
Cable
에에
Display
Cable)
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24
24
ThermaChoice
II
System
Operating
Manual
GYNECARE
A
Division
of
EFHICONnc.
a
fofmon.ffofmwon
company
THERMACHOICET@
Uterine
Balloon
Therapy
Thermal
Read
all
This
manual
Therapy
Caution:
with
appropriate
DEVICE
The
ThermaChoice
uterine
catheter, a reusable
UBT
catheters
The
balloon
into
the
carefully
thermally
87°C
(188°F)
The
ThermaChoice
the
balloon
a)
ThermaChoice HC
fluid
b)
ThermaChoice
fluid
c)
ThermaChoice
circulation
Caution:
rubber
Balloon
directions,
provides
(UBT)
Federal
DESCRIPTION
tissue
by
are
catheter
uterus,
stabilizing
ablate
for 8 minutes.
catheter.
circulation
circulation
The
ThermaChoice
latex
which
INDICATIONS
The
ThermaChoice
the
endometrial
(excessive
uterine
cautions
directions
System.
law
(USA)
training.
UBT
System
thermal
energy.
controller,
designed
is
1)
connected
3)
filled
with
the
pressure
endometrial
II
UBT
They
balloon
mechanism
HI
balloon
mechanism
balloon
mechanism
may
cause
ll
UBT
lining
of
the
bleeding)
Ablation
and
warnings
for
restricts
System
using
this
device
prior
the
ThermaChoice
to
is a software-controlled
The
system
is
comprised
umbilical
for
use
sterile,
tissue
controller
are:
catheter (version
catheter
catheter
inside
balloon
allergic
System
uterus
due
to
cable,
and
only
with
ThermaChoice
to
the
controller,
injectable
to
160-180
by
is
inside
inside
(version
the
balloon
catheter
is a thermal
in
pre-menopausal
benign
fluid
mmHg
maintaining a temperature
designed
the
balloon
(version
the
balloon
1.2):
(see
version
reactions.
balloon
causes
to
use.
sale
power
2)
(plain
pressure,
to
work
2.0):
(see
1.4):
This
(see
This
Diagram
ablation
for
whom
II
Uterine
by
or
on
the
order
device
designed
of a single-use
cord.
The
ThermaChoice
UBT
controllers.
inserted
5%
dextrose
and
through
4)
activated
of
approximately
with 3 different
This
balloon
Diagram
version
Diagram
version
3).
1.2
(only)
women
childbearing
catheter
1).
does
2).
does
not
contains
device
intended
with
menorrhagia
Balloon
of a physician
to
ablate
balloon
the
cervix
in
water - D,W)
to
versions
not
have a fluid
natural
is
of
has
have
to
ablate
complete.
a
a
ThermaChoice
II
System Operating
Manual
Page
1
Diagram
=:
4
Circulating
Front
Catheter
temperature
Intra-balloon
Fmi
1
ThermaChoice
Silicone
balloon
=
/
Heater
element
Panel
of
Controller
heater
display
display
He)
8)
IIC
Single
Depth,
/Fluid
Rea
Catheter
connection
cable
(°C)
=
Use
Balloon
Version
sound
fill
valve
valve)
umbilical
Connectioı
Catheter
2.
d
measurement
SÊ
m
with
Umbilical
Hazard
Start
Message
display
(cm)
à
Fluid
Circulation
Cabl
id fi
(o
umbilical
light
button
fill
port
q
Over
relief
W
for
syringe
Circulation
connection
pressure
valve
cable
button
Su
;
HH
Start
ight
çı
Sos
οφ
7
ower
rower
Rear
Page
J
‘Connection
(pre-attached
NOTE;
the
Panel
2
Remove
circulation
of
Controller
Være
reuseable
Connection
(pre-attached
port
to
catheter.
port
for
circulation
single
use
the
plug
Connection
to
before
Lrotal
port
umbilical
for
pressure
single
use
catheter
catheter)
connecting
port
for
time
catheter)
power
display
Fu:
cord
(minutes : seconds)
for
cable
line
balloon
AC
L
Stop
button
DESCRIPTION
Front
Panel
o
OF
of
Controller
Off
On
SYMBOLS
(power:
(power:
disconnection
connection
to
from
the
the
mains)
mains)
个
NER
CATE
WITH
D,W
DB
4
O
Rear
Panel
(See
SPECIFICATIONS
个
of
A
>
Start
Button
When
symbol
will
automatically
section)—consult
An
unilluminated
Message
Display—displays
Displays
Displays
Displays
in
Circulation
Controller
Connection
Location
pressure
heater
total
MINUTES : SECONDS
for
additional
of
is
illuminated, a hazard
terminate
Operator s Manual
symbol
inside
temperature
running
catheter
information.)
port
for
fuses;
type
indicates
balloon
time
connection
power
cord
and
value
©
procedure
normal
prompts
in
mmHg,
inside
balloon
for
preheat
port
rating
Stop
Button
condition
(see
ERROR
for
further
operating
and
error
in
and
therapy
exists
which
MESSAGES
instruction.
conditions.,
messages
°C
Equipotentiality
¢
Class I Type
=
Cover
to
be
o
> 3 ο
2
6
С €
Sa
ThermaChoice
Danger:
anesthetics!
CE-Mark
Product
Medical
II
System
Risk
and
conforms
Devices
Operating
BF
Equipment
removed
of
by
gualified
explosion
identification
to
the
essential
Directive
Manual
if
used
number
93/
service
in
the
presence
of
Notified
requirements
42/EEC.
personnel
of
flammable
Body.
of
the
only
Page
3
Diagram
ThermaChoice
7
Cl
El
/
Heater
Front Panel
2
II
Single
Silicone / Fluid
balloon
/
Catheter
cable
of
Controller
(Trumpet
connection
Use
Balloon
Depth,
sound
fill
valve
valve
umbilical
Catheter
measurement
x
)
(Version
1.4)
(cm)
\
and
Fluid
/
Umbili
fill
port
for
미
Pressure
ο
Over
pressure
relief
valve
syringe
|
ling
Catheter
heater
temperature
Intra-balloon
pressure
(mmHg)
。
switch
Rear
display
7/
Connection
(pre-attached
NOTE:
Do
not
used
Panel
of
Controller
display
\
mnection
Grenade
port
to
not
remove
for
this
(°C)
x
£
‘connection
for
single
version
Message
i
reusable
circulation
port
to
single
use
catheter)
the
plug.
of
umbilical
for
pressure
catheter
the
catheter.
display
L
Total
(minutes : seconds)
port
for
cable
line
use
balloon
The
circulation
D
Hazard
Start
button
A
time
displ.
play
catheter)
port
is
Fuse
Umbilical
light
A
Stop
cable
Start
button
light
button
Page
4
Connection
port
for
AC
power
cord
J
Diagram
ThermaChoice
3
Single
Use
Balloon
Catheter
(Version
1.2)
and
Umbilical
Cable
Latex
_
Front
Intra-balloon
(mmHe)
balloon
/
ea
u
N
Heater
Umbilical
Panel
Catheter
temperature
ressure
heater
display
=
Power
/
switch
Connection
(pre-attached
NOTE:
this
version
Rear
Panel
cable
of
Controller
display
1
P
\
品
Be
Connection
(pre-attached
port
to
Do
not
of
of
Controller
Depth,
<
(°C)
3
ое
Şe
=
reusable
for
circulation
single
remove
the
catheter.
sound
Fluid
fill
(Trumpet
—
Pressure
I
A
二
^
umbilical
port
for
to
single
use
catheter)
the
plug.
measurement
=,
valve)
valve
line
_/
Message
port
pressure
catheter
The
display
L Total
(minutes
for
cable
use
balloon
circulation
(cm)
Hazard
Start
。 i
time
line
catheter)
ας
Ἐν
port
light
button button
^
]
display
:
seconds)
port
is
not
.
A
—
used
for
syringe
[
light
Stop
button
for
;
Start
ThermaChoice
Il
System
Connection
Operating
port
Manual
for
AC
power
cord
J
Page
5
CONTRAINDICATIONS
The
device
is
contraindicated
A
patient
who
is
pregnant
A
patient
with a history
latex
material
A
patient
premalignant
hyperplasia.
A
patient
myometrium
transmural
A
patient
(e.g
cervicitis,
A
patient
WARNINGS
Failure
in
to
serious
The
device
children
following
Endometrial
procedure.
Endometrial
performed
procedures
curettage
ThermaChoice
Endometrial
hyperplasia,
physician's
The
ThermaChoice
Do
not
session
to
adjacent
Use
caution
the
ThermaChoice
be
terminated
follow
patient
(for
with
known
change
with
any
could
myomectomy.
with
active
vaginitis,
with
an
any
instructions
injury.
is
intended
because
this
procedure.
ablation
Pregnancies
ablation
only
by
within
(D&C),
and
UBT
ablation
or
adenocarcinoma
ability
treat
patients
because
of
viscera.
not
to
immediately.
catheter
intrauterine
the
for
or
of
latex
version
or
suspected
of
the
endometrium,
anatomic
exist,
such
genital
endometritis,
for
likelihood
using
after
procedures
medical
the
professionals
uterine
who
have
System.
procedures
to
detect
or
UBT
catheter
for
more
the
potential
perforate
UBT
catheter.
use
in:
who
wants
to
allergy
or
who
1.2
only).
endometrial
such
or
pathologic
as
history
or
urinary
device
or
to
use
only
of
the
ThermaChoice
ablation
using
cavity,
adequate
do
of
make a diagnosis
is
for
than one
for
the
uterine
condition
of
tract
salpingitis,
(IUD)
heed
any
in
women
pregnancy
can
be
the
who
such
as
training
not
eliminate
the
endometrium
single
therapy
transmural
wall
If a perforation
become
previous
currently
pregnant
has
demonstrated a sensitivity
carcinoma
as
unresolved
in
which
classical
infection
warnings
dangerous
at
the
or
cystitis).
in
place.
or
who
do
not
is
significantly
UBT
System
for
ThermaChoice
have
experience
IUD
insertion
and
familiarity
the
potential
and
may
of
such
pathology.
use
only—do
when
is
not
cycle
in a given
injury
to
sounding
present,
in
the
future.
(uterine
precautions
cancer)
adenomatous
weakness
cesarean
time
of
procedure
desire
of
sections
could
to
bear
decreased
is
not a sterilization
both
UBT
System
in
or
dilation
for
mask
reuse
the
uterus
the
the
procedure
mother
and
should
performing
and
with
the
endometrial
the
or
re-sterilize.
treatment
or
injury
uterus
or
to
or
the
or
result
fetus.
be
inserting
should
PRECAUTIONS
The
ThermaChoice
system.
ThermaChoice
Page
To
6
ensure
UBT
UBT
catheter,
proper
System.
controller,
function,
never
use
and
other
umbilical
components
cable
are
with
designed
the
as
a
A
starting
6-15
pressure
activating
When
levels
pressure
is a rapid
and/or
Rapid
present.
present) a uterine
Those
hormone
in
order
unopposed
The
evaluated
-
with a large
-
with a small
-
with
endometrial
-
undergoing
-
who
pressure
ml
of
fluid
(no
fluctuations
the
heating
inserting
decline
of
160-180
drop
uterine
loss
of
slowly
in
perforation.
pressure
Adding
patients
who
replacement
to
avoid
estrogen
safety
and
effectiveness
in
patients:
uterine
uterine
submucosal
resection
repeat
are
post-menopausal.
and
fluid,
additional
the
of
160-180
may
element
do not
during
mmHg
pressure,
during a therapy
wall
have
therapy
increased
replacement
cavity
myomas, a bicornuate
endometrial
mmHg
require
as
greater
is
exceed a pressure
the
course
cannot
remove
Never
fluid
to
defect
such
undergone
should
risk
of
the
(>30
cavity
(<2
ml
/ablation.
much
than
critical
be
balloon
add
the
as a perforation.
endometrial
of
therapy.
ThermaChoice
ml
in
ablation
is
recommended
as
30
ml.
Titration
+10
mmHg
to
of
the
reached
additional
cycle
balloon
for
proper
functioning
of
200
procedure
with
30
catheter
and
fluid
may
indicate a uterine
may
create
ablation
have a progestin
endometrial
in
volume
volume
or
procedures.
adenocarcinoma
UBT
or
uterine
or
uterine
septate
uterus
and
typically
to
at
least
mmHg.
as
the
ml
or
less
check
during a therapy
(or
and
included
requires
achieve a stable
30
seconds)
of
the
Typically,
uterus
relaxes.
of
fluid,
for
catheter
wall
exacerbate
are
later
in
their
associated
System
has
not
sound
>10
sound
<6
cm).
or a previous
cm).
prior
device.
pressure
or
if
leak
cycle.
defect
if
already
placed
regimen
been
fully
to
If
a
there
is
on
with
ADVERSE
Ina
study
mechanism
following
Cramping/pelvic
patients
period
few
EVENTS
of
134
inside
completion
which
and
hours
non-steroidal
Balloon
Nausea
patients
to
Endometritis
of
Therapy
and
in
general
oral
antibiotics.
Post-procedure
defecation
a
reasonable
Hematometra
outside
insertion
A
the
of
single
United
of a uterine
perforation
ThermaChoice
women
immediate
and
(performed
the
balloon),
of
pain—Post-treatment
ranged
the
procedure
from
the
post-operative
rarely
continues
anti-inflammatory
is
usually
sufficient
Vomiting—~Nausea
the
immediate
anesthesia, and
was
reported
symptoms
or
micturition
period
was
the
United
hours
can
in
such
were
of
time
reported
States.
sound.
of
the
uterus
warrants
in
States.
II
System
Operating
with
most
frequent
include:
mild
to
severe
beyond
drugs
and
following
be
easily
2.1%
of
as
pain,
reported.
0.6%
of
In
all
patients,
was
Manual
catheters
period.
without
events
cramping
as
reported
This
the
first
day
(NSAIDs)
to
manage
vomiting
managed
patients.
fever,
evaluation
patients
reported
cramping
were
the
procedure.
All
nausea,
Failure
of
by
treated
the
hematometra
in a procedure conducted
the
fluid
that
have
was
reported
during
cramping
following
prior
to
will
and
and
reported
This
with
medication.
patients
responded
vomiting,
such
symptoms
appropriate
in
clinical
circulation
been
reported
in
91.8%
of
the
intra-operative
typically
ablation.
following
pelvic
for
23.9%
may
last
The
Uterine
pain.
of
the
be
attributed
to a course
difficulty
to
resolve
medical
was
personnel.
studies
conducted
resolved
outside
the
a
use
with
over
with
Page
of
7
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