Thermachoice II (00825) User Manual

Thermachoice II (00825) User Manual
U.S.A. Distribution /Manufactured for:
GYNECARE
a Division of ETHICON, INC.
a Johnson & Johnson company
Somerville, N.J. 08876-0151 USA
Tel: 1-877-ETHICON
Authorized European Representative:
ETHICON GmbH
Robert-Koch-Strasse 1
D-22851 Norderstedt
Germany
Tel: 040/5297-01
EC
Legal Manufacturer
Gynecare
a division of ETHICON, INC.
a Johnson & Johnson company
Somerville, New Jersey 08876-0151
SYMBOLS USED ON LABELING
See instructions for Use
CE Mark and identification number
of Notified Body. Product conforms
to the essential requirements of the
Medical Devices Directive 93/42/EEC.
Somerville, New Jersey 08876-0151
©1994, 1995, 1996, GYNECARE *Trademark
*
GYNECARE THERMACHOICE UBT System
Operating Manual
CE0123
Somerville, New Jersey 08876-0151
US
GB
389614
Table of Contents
Page
Device Description ..................................................................................................1
Indications ................................................................................................................1
Contraindications ....................................................................................................6
Warnings ....................................................................................................................6
Precautions ................................................................................................................7
Adverse Events ........................................................................................................8
Other Adverse Effects ..............................................................................................8
Clinical Trial ..............................................................................................................9
Patient Population ..................................................................................................10
Patient Selection......................................................................................................14
Patient Counseling ................................................................................................14
Pretreatment Preparation of Patient ....................................................................15
Directions for Use ..................................................................................................15
Set-up ........................................................................................................15
Catheter Priming ......................................................................................19
Pressure Titration ....................................................................................19
Treatment ..................................................................................................21
Post-Treatment..........................................................................................22
Operating Parameters/Alarm and Display Messages ....................................22
Error Messages........................................................................................................23
Warranty ..................................................................................................................24
Servicing/Equipment Disposal ............................................................................25
Ordering Information ............................................................................................25
Specifications (Controller & Umbilical Cable) ..................................................25
Environmental Conditions ....................................................................................26
Electromagnetic Interference ................................................................................26
Maintenance ............................................................................................................26
Calibration ................................................................................................26
Fuse Replacement ....................................................................................28
Cleaning: Controller System ..................................................................28
Disinfection: Umbilical Cable ................................................................29
Power Cord ..............................................................................................29
GYNECARE THERMACHOICE UBT System Operating Manual
Somerville, New Jersey 08876-0151
*
Thermal Balloon Ablation System
Read all directions, precautions and warnings prior to use.
This manual provides directions for using the GYNECARE THERMACHOICE Uterine
Balloon Therapy (UBT) System.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
with appropriate training.
DEVICE DESCRIPTION
The GYNECARE THERMACHOICE UBT System is a software-controlled device
designed to ablate uterine tissue by thermal energy. The system is comprised of a
single-use balloon catheter, a reusable controller, umbilical cable, and power cord. The
GYNECARE THERMACHOICE UBT catheters are designed for use only with
GYNECARE THERMACHOICE UBT controllers.
The balloon catheter is 1) connected to the controller, 2) inserted through the cervix
into the uterus, 3) filled with sterile, injectable fluid (plain 5% dextrose in water- D5W)
carefully stabilizing the pressure to 160-180mmHg pressure, and 4) activated to
thermally ablate endometrial tissue by maintaining a temperature of approximately
87°C (188°F) for 8 minutes.
The GYNECARE THERMACHOICE UBT controller is designed to work with
3 different versions of the balloon catheter. They are:
a)
GYNECARE THERMACHOICE IIIC silicone balloon catheter (version 3.0): This
balloon catheter has a fluid circulation mechanism inside the balloon (See Diagram 1).
b)
GYNECARE THERMACHOICE IIC silicone balloon catheter (version 2.0): This
balloon catheter has a fluid circulation mechanism inside the balloon (See Diagram 2).
c)
GYNECARE THERMACHOICE balloon catheter (version 1.2): This version does
not have a fluid circulation mechanism inside the balloon (See Diagram 3).
Caution: The GYNECARE THERMACHOICE balloon catheter version 1.2 (only)
contains natural rubber latex which may cause allergic reactions.
INDICATIONS
The GYNECARE THERMACHOICE UBT System is a thermal ablation device intended
to ablate the endometrial lining of the uterus in women with menorrhagia (excessive
uterine bleeding) due to benign causes for whom childbearing is complete.
GYNECARE THERMACHOICE UBT System Operating Manual
Page 1
Diagram 1
GYNECARE THERMACHOICE IIIC Single Use Silicone Balloon Catheter
with Fluid Circulation (Version 3.0) and Umbilical Cable
Depth, sound measurement (cm)
Silicone
balloon
Fluid fill valve
(Trumpet valve)
Fluid fill port for syringe
Catheter umbilical
cable connection
Heater
Circulating element
Connection
plugs
Pressure line
Circulation
connection
Front Panel of Controller
Catheter heater
temperature display (°C)
Umbilical cable
Hazard light
Intra-balloon
pressure display
(mmHg)
Start
button
light
Start button
Message display
THERMA CHOICE
Uterine Balloon Therapy
PRESSURE (mmHg)
CIRCULATION
PRESSURE LINE
TEMPERATURE (°C)
TIME
(min: sec)
UMBILICAL CABLE
Total time display
(minutes : seconds)
Power
switch
Stop button
Connection port for
reuseable umbilical cable
Connection port for pressure line
(pre-attached to single use balloon catheter)
Connection port for circulation catheter
(pre-attached to single use catheter)
NOTE: Remove the plug before connecting
the circulation catheter.
Fuse
Rear Panel of Controller
WARNING: RISK OF
FIRE, REPLACE
FAST BLOW FUSE
AS MARKED.
CAUTION
2X
1.6A@250V FAST BLOW
ATTENTION
CAUTION
CAUTION
MODEL NUMBER
SERIAL NUMBER
0123
Manufactured For:
GYNECARE
a Division of ETHICON, INC.
a Johnson & Johnson Company
Somerville, NJ 08876-0151
1-877-ETHICON
01511 Rev C
Connection port for AC power cord
Page 2
100-240V~
50/60 Hz
1.1A@120V~
0.55A@240V~
See instruction
for use
DESCRIPTION OF SYMBOLS
Front Panel of Controller
Off (power: disconnection from the mains)
On (power: connection to the mains)
Start Button
Stop Button
When symbol is illuminated, a hazard condition exists which
willautomatically terminate procedure (see ERROR MESSAGES
section)—consult Operator ’s Manual for further instruction. An
unilluminated symbol indicates normal operating conditions.
INSERT CATHETER
FILL CATHETER
Message Display—displays prompts and error messages
WITH D5W
Displays pressure inside balloon in mmHg
Displays heater temperature inside balloon in °C
Displays total running time for preheat and therapy
in MINUTES : SECONDS
Circulation catheter connection port
Rear Panel of Controller
(See SPECIFICATIONS for additional information.)
Connection port for power cord
Location of fuses; type and value rating
Equipotentiality
Class I Type BF Equipment
Cover to be removed by qualified service personnel only
CAUTION
Danger: Risk of explosion if used in the presence of flammable
anesthetics!
0123
CE-Mark and identification number of Notified Body.
Product conforms to the essential requirements of the
Medical Devices Directive 93/42/EEC.
GYNECARE THERMACHOICE UBT System Operating Manual
Page 3
Diagram 2
GYNECARE THERMACHOICE IIC Single Use Silicone Balloon Catheter
with Fluid Circulation (Version 2.0) and Umbilical Cable
Depth, sound measurement (cm)
Silicone
balloon
Fluid fill valve
(Trumpet valve)
Fluid fill port for syringe
Catheter umbilical
cable connection
Heater
Circulating element
Connection
plugs
Pressure line
Circulation
connection
Over pressure
relief valve
Front Panel of Controller
Catheter heater
temperature display (°C)
Umbilical cable
Hazard light
Intra-balloon
pressure display
(mmHg)
Start
button
light
Start button
Message display
THERMA CHOICE
Uterine Balloon Therapy
PRESSURE (mmHg)
CIRCULATION
PRESSURE LINE
TEMPERATURE (°C)
TIME
(min: sec)
UMBILICAL CABLE
Total time display
(minutes : seconds)
Power
switch
Stop button
Connection port for
reuseable umbilical cable
Connection port for pressure line
(pre-attached to single use balloon catheter)
Connection port for circulation catheter
(pre-attached to single use catheter)
NOTE: Remove the plug before connecting
the circulation catheter.
Fuse
Rear Panel of Controller
WARNING: RISK OF
FIRE, REPLACE
FAST BLOW FUSE
AS MARKED.
CAUTION
2X
1.6A@250V FAST BLOW
ATTENTION
CAUTION
CAUTION
MODEL NUMBER
SERIAL NUMBER
0123
Manufactured For:
GYNECARE
a Division of ETHICON, INC.
a Johnson & Johnson Company
Somerville, NJ 08876-0151
1-877-ETHICON
01511 Rev C
Connection port for AC power cord
Page 4
100-240V~
50/60 Hz
1.1A@120V~
0.55A@240V~
See instruction
for use
Diagram 3
GYNECARE THERMACHOICE Single Use Balloon Catheter (Version 1.2)
and Umbilical Cable
Depth, sound measurement (cm)
Latex
balloon
Fluid fill port for syringe
(Soft luer)
Fluid fill valve
(Trumpet valve)
Heater
Connection plugs
Umbilical cable
Pressure line
Front Panel of Controller
Catheter heater
temperature display (°C)
Hazard light
Intra-balloon
pressure display
(mmHg)
Start
button
light
Start button
Message display
THERMA CHOICE
Uterine Balloon Therapy
PRESSURE (mmHg)
CIRCULATION
PRESSURE LINE
TEMPERATURE (°C)
TIME
(min: sec)
UMBILICAL CABLE
Total time display
(minutes : seconds)
Power
switch
Stop button
Connection port for
reusable umbilical cable
Connection port for pressure line
(pre-attached to single use balloon catheter)
Connection port for circulation catheter
(pre-attached to single use catheter)
NOTE: Do not remove the plug. The circulation port is
not used for this version of the catheter.
Fuse
Rear Panel of Controller
WARNING: RISK OF
FIRE, REPLACE
FAST BLOW FUSE
AS MARKED.
CAUTION
ATTENTION
2X
1.6A@250V FAST BLOW
CAUTION
CAUTION
MODEL NUMBER
SERIAL NUMBER
0123
Manufactured For:
GYNECARE
a Division of ETHICON, INC.
a Johnson & Johnson Company
Somerville, NJ 08876-0151
1-877-ETHICON
100-240V~
50/60 Hz
1.1A@120V~
0.55A@240V~
See instructions
for use
01511 Rev C
Connection port for AC power cord
GYNECARE THERMACHOICE UBT System Operating Manual
Page 5
CONTRAINDICATIONS
The device is contraindicated for use in:
•
•
•
•
•
•
A patient who is pregnant or who wants to become pregnant in the future.
A patient with a history of latex allergy or who has demonstrated a sensitivity
to latex material (for catheter version 1.2 only).
A patient with known or suspected endometrial carcinoma (uterine cancer)
or pre-malignant change of the endometrium such as unresolved adenomatous
hyperplasia.
A patient with any anatomic or pathologic condition in which weakness of the
myometrium could exist, such as history of previous classical cesarean sections
or transmural myomectomy.
A patient with active genital or urinary tract infection at the time of procedure
(e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
A patient with an intrauterine device (IUD) currently in place.
WARNINGS
Failure to follow all instructions or to heed any warnings or precautions could result
in serious patient injury.
• The device is intended for use only in women who do not desire to bear children
because the likelihood of pregnancy is significantly decreased following this
procedure. There have been reports of women becoming pregnant following this
procedure. Pregnancies after ablation can be dangerous for both mother and fetus.
• Endometrial ablation using the GYNECARE THERMACHOICE UBT System is not a
sterilization procedure.
• Patients who undergo endometrial ablation procedures who have previously
undergone tubal ligation are at increased risk of developing post ablation tubal
sterilization syndrome which can require hysterectomy. This can occur as late as 10
years post-procedure.
• Endometrial ablation procedures using the GYNECARE THERMACHOICE UBT
System should be performed only by medical professionals who have experience in
performing procedures within the uterine cavity, such as IUD insertion or dilation and
curettage (D&C), and who have adequate training and familiarity with the
GYNECARE THERMACHOICE UBT System.
• Endometrial ablation procedures do not eliminate the potential for endometrial
hyperplasia, or adenocarcinoma of the endometrium and may mask the physician’s
ability to detect or make a diagnosis of such pathology.
• The GYNECARE THERMACHOICE III UBT Balloon Catheter is for single use only –
do not reuse or resterilize.
• Do not treat patients for more than one therapy cycle in a given treatment session
because of the potential for transmural injury to the uterus or injury to adjacent
viscera.
• UTERINE PERFORATION
• Uterine perforation can occur during any procedure in which the uterus is
instrumented. Use caution not to perforate the uterine wall when sounding the
uterus, dilating the cervix or inserting the catheter.
• Any of the following indicates possible uterine perforation.
Page 6
1. If the catheter can be inserted to a greater depth than was determined by the
uterine sound
2. If the pressure cannot be stabilized at 160 – 180 mmHg with a maximum of
30ml of fluid
3. If the pressure drops quickly at any point during the procedure
• If a perforation is suspected, THE PROCEDURE SHOULD BE TERMINATED
IMMEDIATELY. The physician may elect to perform a diagnostic procedure to
confirm perforation. If the physician cannot absolutely rule out perforation, the
procedure should be abandoned.
• For patients in whom the procedure was aborted due to a suspected uterine wall
perforation, a work-up for perforation should be considered prior to discharge.
• If a perforation is present, and the procedure is not terminated, thermal injury to
adjacent tissue may occur if the heater is activated.
• After completing the procedure it is important not to touch the GYNECARE
THERMACHOICE Uterine Balloon for the following reasons:
- The balloon is covered with blood and body fluids
- There are mechanical and electrical parts that could puncture the balloon
• Proper care should be taken in disposing of the catheter.
PRECAUTIONS
• The GYNECARE THERMACHOICE III UBT catheter, controller, and umbilical cable are
designed as a system. To ensure proper function, never use other components with the
GYNECARE THERMACHOICE UBT System.
• A starting pressure of 160 – 180 mmHg is recommended and typically requires
6 – 15 ml of fluid and may require as much as 30 ml. Titration to achieve a stable
pressure (no fluctuations greater that ±10 mmHg for at least 30 seconds) prior to
activating the heating element is critical to proper functioning of the device. When
inserting fluid, do not exceed a pressure of 200 mmHg. Typically, pressure levels
decline slowly during the course of the procedure as the uterus relaxes. If a pressure of
160 – 180 mmHg cannot be reached with 30 ml or less of fluid, or if there is a rapid
drop in pressure, it is likely there is a uterine perforation.
• Rapid loss of pressure during a therapy cycle may indicate a uterine wall defect.
Adding additional fluid to the balloon may create (or exacerbate if already present) a
uterine wall defect such as a perforation.
• Those patients who have undergone endometrial ablation and are later placed on
hormone replacement therapy should have progestin included in their regimen in
order to avoid the increased risk of endometrial adenocarcinoma associated with
unopposed estrogen replacement therapy.
• Never add additional fluid during a therapy cycle.
• The safety and effectiveness of the GYNECARE THERMACHOICE UBT System has
not been fully evaluated in patients:
- with large uterine cavities (>30 ml in volume or uterine sound >12 cm)
- with small uterine cavities (<2 ml in volume or uterine sound <4 cm)
- with submucosal myomas, bicornuate or septate uteri or previous endometrial
resection/ablation
- undergoing repeat endometrial ablation procedures
GYNECARE THERMACHOICE UBT System Operating Manual
Page 7
- who are post-menopausal
• It has been reported that patients with a severe anteverted retroflexed or laterally
displaced uterus are at an increased risk of uterine wall perforation during any
intrauterine manipulation. The clinician should use discretion in patient selection.
• A false passage can occur during any procedure in which the uterus is instrumented,
especially in cases of severe anteverted retroflexed or a laterally displaced uterus. Use
caution to insure that the device is properly positioned in the uterine cavity.
ADVERSE EVENTS
CLINICAL STUDY
In a study of 134 women performed with a previous generation balloon catheter
(version 1.2) [without the fluid circulation mechanism inside the balloon], the most
frequent events that have been reported following completion of the procedure
include:
•
•
•
•
•
•
•
Cramping/pelvic pain – Post-treatment cramping was reported in 91.8% of the
patients which ranged from mild to severe as reported during the intra-operative
and immediate post-operative period. This cramping will typically last a few
hours and rarely continues beyond the first day following ablation. The use of
non-steroidal anti-inflammatory drugs (NSAIDs) prior to and following UBT is
usually sufficient to manage cramping and pelvic pain.
Nausea and Vomiting – Nausea and vomiting were reported for 23.9% of the
patients in the immediate hours following the procedure. This may be attributed
to general anesthesia, and can be easily managed with medication.
Endometritis was reported in 2.1% of patients. All patients responded to a course
of oral antibiotics.
Post-procedure symptoms such as pain, fever, nausea, vomiting, difficulty
with defecation or micturition were reported. Failure of such symptoms to resolve
over a reasonable period of time warrants evaluation by appropriate medical
personnel.
Pregnancy was reported in one patient (0.8%) resulting in a 2-month premature
live infant. Pregnancy following endometrial ablation is dangerous to both mother
and fetus.
Hematometra was reported in 0.6% of patients treated in clinical studies
conducted outside of the United States. In all patients, the hematometra was
resolved with insertion of a uterine sound.
A single perforation of the uterus was reported in a controlled clinical study.
OTHER ADVERSE EFFECTS
As with all endometrial ablation procedures, serious injury or death can occur. The
following adverse effects might be potentially expected or have been reported in
association with the use of the GYNECARE THERMACHOICE UBT System:
1. Rupture of the Uterus
2. Thermal Injury to Adjacent Tissue
3. Heated Liquid Escaping Into the Vascular Spaces and/or Cervix, Vagina, Fallopian
Tubes, and Abdominal Cavity
4. Electrical Burn
5. Hemorrhage
Page 8
6. Infection or Sepsis
7. Perforation
8. Post-ablation-tubal sterilization syndrome – This is a complication following
endometrial ablation in women who have also previously undergone tubal ligation.
The pathophysiology of this condition is believed to be related to the regeneration of
endometrium in the cornual areas of the uterus. Blood from these glands can flow
back into the proximal fallopian tubes in cases where the lower uterine segment is
extensively scarred. The proximal oviduct becomes filled with blood and fluid causing
symptoms similar to those of an ectopic pregnancy.
9. Complications leading to serious injury or death.
CLINICAL TRIAL
The GYNECARE THERMACHOICE IIIC catheter (version 3.0) and GYNECARE
THERMACHOICE IIC catheter (version 2.0) includes an active mechanism for
circulation of the D5W within the balloon. The GYNECARE THERMACHOICE
catheter (version 1.2) has a passive circulation which is based on convection. The
clinical data presented below were obtained using the previous generation noncirculating balloon catheter, however, laboratory testing (ex-vivo experiments
conducted on extirpated human uteri) has shown that the active circulation of fluid
within the balloon will lead to a more even distribution of heat at the balloon surface,
and thereby over the endometrial tissue.
Conclusions: In a study performed with a previous generation balloon catheter
(version 1.2) [without the fluid circulation mechanism inside the balloon] at twelve,
twenty-four, and thirty-six months of follow-up, balloon ablation was demonstrated to
be at least as safe (with fewer intra-operative complications and shorter procedure
times), and as effective as hysteroscopic rollerball ablation in reducing menstrual
bleeding to a clinically acceptable level in menorrhagic women who had completed
their childbearing. Furthermore, statistically equivalent and significant reductions in
patient-reported dysmenorrhea (mild, moderate, severe menstrual cramps), PMS
symptoms (mild, moderate, severe common PMS symptoms), and overall impact of
menses on lifestyle (scale of 1-10; 1=none, 10=severe) were experienced by both
groups.
Purpose: The use of balloon thermal ablation for the treatment of menorrhagia for
benign causes in an anatomically normal uterine cavity was compared with rollerball
electrosurgical endometrial ablation with regard to safety and effectiveness. The
primary effectiveness measure was a validated diary scoring system (adapted from
Higham JM, O’Brien PMS, Shaw RW, Assessment of menstrual blood loss using a
pictorial chart, Br J Obstet Gynaecol 1990;97:734-9). Success was defined as the
reduction of excessive menstrual bleeding to normal flow or less. Secondary endpoints
evaluated were overall percent decrease in diary scores and responses from a qualityof-life questionnaire. The endpoints for safety were based on the evaluation of adverse
events associated with each procedure, including device-related complications, time of
procedure, and type of anesthesia use.
Methods: This randomized, prospective, multicenter clinical investigation obtained
using the previous generation non-circulating balloon catheter was conducted at 14
sites using investigators highly experienced with hysteroscopic rollerball endometrial
ablation. All patients were >30 years old, premenopausal, and had completed
childbearing. All had an anatomically normal uterine cavity >4 cm and <10 cm.
GYNECARE THERMACHOICE UBT System Operating Manual
Page 9
Three months of documented menorrhagia for benign causes was a requirement for
inclusion and was confirmed with a diary score of at least 150 points. Endometrial
biopsy and pap smear were required to rule out (pre)malignant uterine disease. No
uterine thinning medications could be used for three months prior to treatment, and
all patients underwent a three-minute suction curettage just prior to treatment.
Selection of anesthesia regimen was left to the individual investigators. Treatment
success was defined as reduction in menses to a diary score less than or equal to 75 in
order to assure a return to eumenorrhea. In the original Higham study, a diary score of
100 had an 86% sensitivity and an 81% specificity for true menorrhagia for benign
causes as determined by chemical analysis of the saturated pads.
PATIENT POPULATION
•
•
260 patients in Safety Evaluation Group (134 TC; 126 RB)
- 1 aborted RB for uterine perforation
- 2 aborted (1 TC; 1 RB) for submucous fibroid
- 2 aborted TC for inability to maintain device pressure
255 patients treated with test or control device (131 TC; 124 RB)
Baseline demographic, physical exam and gynecological variables were statistically
equivalent between the test and control groups with regard to age (TC 40.2 years, RB
40.9 years), race, body mass index, mean baseline diary score (TC 552.5, RB 570) and
other parameters.
Page 10
Subject Withdrawals - Table Ia
Subjects:
Entered into study
(Intent to Treat Population)
Procedure aborted
Receiving complete treatment
For whom 12-month data
not available:
Hysterectomy
Withdrew
GYNECARE THERMACHOICE
ROLLERBALL
134
126
3
2
131
124
6
10
2
1
3
4
- 1 daughter’s death
- 1 menorrhagia
- 1 depression
- 1 amenorrhea @ 3 mo.
Lost to follow-up
3
3
- 1 diary score 14
- 1 amenorrhea @ 3 mo.
- 1 amenorrhea @ 3 mo.
- 1 6-mo. diary score 32
- 1 6-mo. diary score 77
For whom 12-month data available:
For whom 24-month data
not available:
Hysterectomy
Lost to follow-up
125
114
3
2
1
9
6
3
- 1 yr. hypomenorrhea
For whom 24-month data
available:
122
For whom 36-month data
not available:
Repeat Ablation
8
1
Hysterectomy
Lost to follow-up
4
105
5
2
- both hypomenorrhea @ 2 yr.
Withdrew
For whom 36-month data
available:
1
114
GYNECARE THERMACHOICE UBT System Operating Manual
100
Page 11
RESULTS
EFFECTIVENESS
Table Ib. Effectiveness Bleeding Rates shows the success rates for the Intent to Treat
Group (134 TC; 126 RB) as based on diary scores at the 1-year follow-up of 75 or less.
Success at 24 and 36 months, based on telephone questionnaires, is defined as
elimination of bleeding or reduction to light or normal flow. The worst-case scenario is
presented whereby each of the discontinued patients (described below in the
footnotes) is counted as a "failure" for calculating the values listed in the table. Only
the amenorrhea rate at 1 year is statistically significantly different between treatment
groups (P ≤ 0.05).
Table Ib. Effectiveness Bleeding Rates
Intention to Treat Group†
GYNECARE THERMACHOICE UBT
ROLLERBALL
n=134
n=126
Months Post Treatment
12 a
24b
36b
12 a
24b
Number of Successful Patients
101
109
106
97
95
94
75.4%*
81.3%*
79.1%*
77.0%*
75.4%*
74.6%*
19
16
17
31
23
27
14.2%**
11.9%*
12.7%*
24.6%*
18.2%*
21.4%*
Study Success Rate
36b
# of Patients with Amenorrhea
(# Patients with diary scores = 0)
Amenorrhea Rate
(% Patients with diary scores = 0)
a - based on diary scores
b - based on telephone questionnaires
*Not Statistically Significant (P> 0.05)
**Statistically Significant (P ≤ 0.05)
†See Table 1a for Subject Withdrawals
Page 12
Table Ic. Effectiveness Quality of Life presents the quality of Life Questionnaire
responses for patients who responded at 12, 24 and 36 months. Patients discontinued
prior to the visit (described in Table 1a) were not included in the calculations. There
were no statistically significant differences between groups.
Table Ic. Effectiveness Quality of Life†
GYNECARE THERMACHOICE UBT
ROLLERBALL
Months Post Ablation
12
24
36
12
24
36
# of Patients Who Responded to
Quality of Life Questionnaire
125
122
114
114
105
100
% Patients with anemia
pre-treatment (HCT)
29.9%
N/A
N/A
29.7%
N/A
N/A
% Patients with anemia
post-treatment (HCT)
11.6%
N/A
N/A
10.6%
N/A
N/A
Satisfaction:
very satisfied or satisfied
96.0%
95.9%
95.6%
98.2%
98.1%
97.0%
% Patients with reduction in
dysmenorrhea
70.4%
72.1%
73.7%
75.4%
75.2%
78.0%
% Patients unable to work
outside the home pre-treatment
39.7%
39.7%
39.7%
41.9%
41.9%
41.9%
% Patients unable to work
outside the home post-treatment
4.0%
0.8%
2.7%
2.7%
2.9%
1.0%
% Patients reporting severe
impact on life pre-treatment
70.3%
70.3%
70.3%
78.6%
78.6%
78.6%
% Patients reporting severe
impact on life post-treatment
3.2%
4.9%
1.8%
1.8%
1.0%
2.0%
†See Table 1a for Subject Withdrawals
SAFETY
Table II. Safety shows there were no intra-operative adverse events and 4 postoperative adverse events in the GYNECARE THERMACHOICE UBT Group (n=134).
In the Rollerball Group (n=126) there were 4 intra-operative adverse events and 3
adverse events in the immediate post-operative period. These differences were not
statistically significant. The mean procedure time for the TC patients was statistically
significantly less than for the RB patients.
Table II. Safety
GYNECARE THERMACHOICE
UBT n=134
ROLLERBALL
n=126
Intra-operative adverse events
None
(0%)
Post-operative adverse events
1 post-coital bleeding
3 endometritis
1 UTI
(3.7%)*
2 fluid overload
1 cervical laceration
1 uterine perforation
(3.2%)
1 endometritis
1 hematometra
1 PATSS 1
(2.4%)*
27.4**
39.6**
Mean procedure time(minutes)
Procedure time is duration between
patient prep and catheter removal
1 PATSS = post-ablation-tubal sterilization syndrome
*Not Statistically Significant (P> 0.05)
**Statistically Significant (P< 0.05)
GYNECARE THERMACHOICE UBT System Operating Manual
Page 13
ANESTHESIA REGIMEN
Selection of anesthesia regimen was left to the individual investigators. Fewer cases
were performed under general anesthesia in the GYNECARE THERMACHOICE UBT
group as compared to the Rollerball group. For GYNECARE THERMACHOICE UBT
only 53.7% had the procedure under general anesthesia versus 84.1% who had the
Rollerball procedure performed using general anesthesia.
HYSTERECTOMY
There were a total of 22 patients (8 TC; 14 RB) who had a hysterectomy within 3 years
after endometrial ablation.
Table III. Hysterectomy
Reason for Hysterectomy
Total*
TC (n=134) RB (n=126)
Possible Carcinoma (found negative)
Menorrhagia/abnormal bleeding
0
3
1
5
Pelvic pain/severe dysmenorrhea
4
6
Endometriosis/ovarian cysts
1
2
8 (8.6%)
14 (11.1%)
Total
*13 hysterectomies were in patients <40 years (4 TC, 9 RB); 9 hysterectomies were in patients >40 years (4 TC, 5 RB)
PATIENT SELECTION
Menorrhagia can be caused by a variety of underlying problems including but not
limited to, endometrial cancer, myomas, polyps, anovulation, drugs, and dysfunctional
uterine bleeding. Patients should always be evaluated to determine the cause of their
excessive uterine bleeding before any treatment option is initiated.
Consult medical literature relative to various endometrial ablation techniques,
indications, contraindications, complications, and hazards prior to the performance
of any endometrial ablation procedures.
The patient selection criteria are:
•
•
•
•
•
•
•
Documented diagnosis of menorrhagia for benign causes
Completed childbearing
Premenopausal
Normal pap smear and endometrial biopsy
Anatomically normal uterine cavity: standard sonography, saline infusion
sonography, hysteroscopy, or hysterosalpingography within 6 months prior to
performing GYNECARE THERMACHOICE UBT should be used to rule out
submucous fibroids, large polyps, and congenital abnormalities
Uterine cavity depth of 4-12 cm
Failed or contraindicated medical therapy
PATIENT COUNSELING
As with any procedure the physician needs to discuss risks, benefits and alternatives
with the patient prior to performing endometrial ablation. In addition, the physician
should discuss signs and symptoms of potential complications such as bleeding, infection
or thermal injury.
Page 14
The device is intended for use only in women who do not desire to bear children
because the likelihood of pregnancy is significantly decreased following this
procedure. Post-procedure pregnancy may be dangerous for both mother and fetus.
Patients of childbearing capacity should be counseled that endometrial ablation is not
a sterilization procedure and should be provided an appropriate birth control method.
Patients with childbearing capacity should be cautioned of the potential complications
which may ensue if they should become pregnant.
Vaginal discharge is typically experienced during the first few days following ablation
and may last as long as a few weeks. Generally, the discharge is described as bloody
during the first few days; serosanguinous by approximately one week; then profuse
and watery thereafter.
PRETREATMENT PREPARATION OF PATIENT
The lining of the uterus should be thinned prior to GYNECARE THERMACHOICE
UBT. This can be accomplished by timing the menstrual cycle to the early proliferative
phase, administering pretreatment drugs such as danocrine or GnRH agonists, or
performing suction or sharp curettage immediately prior to performing the
endometrial ablation. The optimum pretreatment regimes have not been determined
at this time.
It is recommended that a non-steroidal anti-inflammatory drug (NSAID) be given at
least one hour prior to treatment and continued post-operatively as necessary to
reduce intra-operative and post-operative uterine cramping.
DIRECTIONS FOR USE
Please read all directions, precautions and warnings prior to use.
1.0 SET-UP
1.1 The following items are required for use of the GYNECARE THERMACHOICE
UBT System.
GYNECARE THERMACHOICE UBT System
• 1 sterile disposable balloon catheter (see catheter version matrix
below) and syringe (30 ml)
• 1 umbilical cable
• 1 controller
• 1 power cord
Catheter Version 3.0
Circulation catheter
Silicone balloon
Catheter Version 2.0
Circulation catheter
Silicone balloon
Catheter Version 1.2
Non-circulation
catheter
Latex balloon
GYNECARE THERMACHOICE UBT System Operating Manual
Has fluid circulation
mechanism inside
the balloon
Has fluid circulation
mechanism inside
the balloon
Does not have fluid
circulation
mechanism
Page 15
Medical Supplies
• 50 ml sterile injectable plain 5% dextrose in water (D5W)
• tenaculum (weighted) speculum
• uterine sound, cervical dilator(s)
• sterile drape for umbilical cord (optional)
Note: Use only plain D5W to inflate balloon catheter - never use any
other fluid.
1.2 Open the sterile package containing the GYNECARE THERMACHOICE
UBT Catheter and Syringe. Disinfect umbilical cable as described at the end of
this manual.
1.3 Make sure that the controller power is off before making the connection (Steps
1.4 – 1.6).
1.4 Plug the power cord into the back of the controller and into the wall outlet.
1.5 The umbilical cable includes a connector plug at each end to connect the balloon
catheter to the controller. Visually inspect the cable and connector plugs to ensure
there are no defects or signs of wear. Drape umbilical cable with sterile drape,
if necessary, and attach cable to the connector on the catheter umbilical cable
connection (for catheters version 3.0 and 2.0) or at the end of the balloon catheter
for version 1.2 (match arrows on umbilical cable to notch on catheter). Attach
the opposite end of the cable to the connection port on the front panel of
controller. (Align red dots from umbilical cable to controller). (See Diagram 4
for circulation catheter versions 3.0 and 2.0 and Diagram 5 for non-circulation
catheter version 1.2).
Page 16
Diagram 4
GYNECARE THERMACHOICE IIIC Silicone Balloon Catheter with Fluid Circulation (Version 3.0)
Catheter umbilical
cable connection
Controller
Match arrows
together*
Detail “A ”
Remove the plug
before connecting
the circulation
catheter
Align red dots
from umbilical
cable to controller
Umbilical
cable
Detail “B ”
Circulation catheter
connection
Pressure line filter
(Ensure a snug connection)
GYNECARE THERMACHOICE IIC Silicone Balloon Catheter with Fluid Circulation (Version 2.0)
Catheter umbilical
cable connection
Controller
Match arrows
together*
Detail “A ”
Remove the plug
before connecting
the circulation
catheter
Align red dots
from umbilical
cable to controller
Umbilical
cable
Detail “B ”
Circulation catheter
connection
Pressure line filter
(Ensure a snug connection)
GYNECARE THERMACHOICE UBT System Operating Manual
Page 17
Diagram 5
GYNECARE THERMACHOICE Catheter (Version 1.2)
Match arrows on
umbilical cable to
notch on catheter*
Detail “A ”
Do not remove plug.
The circulation port is
not used for this
version of the
catheter.
Controller
Align red dots
from umbilical
cable to controller
Pressure line filter
(Ensure a snug connection)
Detail “B ”
1.6 Connect the pressure line (pre-attached to balloon catheter) to the connection
port (luer lock) on the front panel of controller. Do not overtighten, but ensure a
snug connection or the device may not function properly. (See Diagram 4-5).
Periodically clean the entrance of the controller’s port, using a cotton swab with
50% isopropyl alcohol. Ensure that the pressure line is fully connected prior to
adding any fluid to the system.
1.7 Use this step for the GYNECARE THERMACHOICE IIC and IIIC silicone
balloon catheter with fluid circulation (version 2.0 and version 3.0) only.
Remove the plug from the circulation catheter port. To remove the plug, press on
the locking latch and pull the plug. Save the plug. It should be reinstalled when
the controller is not in use. Connect the circulation catheter plug into the circulation
port. It will lock in place with a slight click. Make sure it’s locked in by slightly
pulling on it.
1.8 TURN ON the controller POWER. The Message Display will read:
Message Display:
Note: N.NN = software revision level
REVISION N.NN
INITIALIZING
Message Display:
CONNECT CATHETER
Once catheter is connected,
the Message Display will read:
PRIME CATHETER
The pressure line MUST be connected to the controller BEFORE the balloon
catheter is filled with fluid, or the device will not function properly.
Page 18
2.0 CATHETER PRIMING
2.1 FILL the 30 ml syringe with approximately 5-10 ml (consistency w/2.4) of sterile
injectable 5% dextrose in water (D5W).
Use only sterile injectable 5% dextrose in water (D5W). Use of other fluids may
compromise system.
2.2 CONNECT the syringe to the port in the proximal end of the balloon catheter. Do
not overtighten syringe when connecting.
2.3 Point balloon catheter tip downward.
2.4 Press trumpet valve on top of balloon catheter handle and slowly fill with
5-10 ml of D5W. Ensure that the pressure does not go above 200 mmHg indicated by
the pressure display on the controller.
2.5 Press trumpet valve and evacuate fluid and air from balloon to a negative
pressure of –150 to –200 mmHg (indicated by pressure display on controller).
Note: You may need to purge air from syringe several times to attain desired
negative pressure. You must release trumpet valve to maintain negative pressure.
Air should be completely evacuated to optimize the function of the device.
During priming, when catheter pressure is
<-150 mmHg, the Message Display is:
PRIME CATHETER
<-150 mmHg
DO NOT EXCEED - 200 mmHg negative pressure during evacuation.
2.6 The negative pressure creates a low-profile balloon insertion (balloon is drawn
tight against catheter tip). Do not go beyond –200 mmHg. Check that negative
pressure is maintained for at least 10 seconds before proceeding.
Once catheter pressure is >-150 mmHg,
the Message Display is:
INSERT CATHETER &
FILL WITH D5W
If negative pressure cannot be maintained for 10 seconds, remove the balloon
catheter and replace.
3.0 PRESSURE TITRATION
3.1 Fill syringe to 30 ml with D5W, purge air, and connect to balloon catheter (do not
overtighten). Do not use more than 30 ml of D5W.
3.2 Measure depth of uterus.
3.3 Using appropriate sterile technique and cervical/vaginal preparation, dilate cervix
to 5 mm if necessary. If a perforation is suspected at this point, perform appropriate
diagnostic measures to evaluate for perforation before proceeding. If perforation can
not be ruled out, abandon the procedure.
3.4 Wet the outside of balloon with D5W.
3.5 After sounding the uterus, and wetting the balloon, SLOWLY INSERT THE
BALLOON CATHETER into the uterus until the tip is touching the fundus.
Ensure that the depth indicated by markings on catheter is consistent with
GYNECARE THERMACHOICE UBT System Operating Manual
Page 19
previous sound measurement. Use a tenaculum to hold the cervix if necessary.
3.6 Ensure that the cervix is dilated to 5mm and do not use excessive force during
insertion, as such force can cause the balloon to tear or the catheter to perforate
the uterine wall. If a perforation is suspected at this point, perform appropriate
diagnostic measures to evaluate for perforation before proceeding. If perforation can not
be ruled out, abandon the procedure.
3.7 Press trumpet valve on top of balloon catheter and fill balloon slowly to pressure
of 160-180 mmHg using 2-30 ml of D5W (Release the trumpet valve to allow the
pressure to stabilize). Do not allow the pressure to exceed 200 mmHg during
titration. Incrementally add small volumes to achieve a stable pressure (no
fluctuations greater than +10 mmHg) of 160-180 mmHg for a minimum of 30
seconds. The pressure of the balloon against the uterine wall often precipitates uterine
contraction, thereby temporarily increasing the pressure reading.
If pressure cannot be stabilized at 160-180 mmHg for 30-45 seconds with 30 ml of
fluid, this may indicate uterine perforation. Remove the balloon catheter. If a
balloon leak is present, replace the catheter and continue with the procedure. If no
balloon leak is found, perform appropriate diagnostic measure to evaluate for
perforation before proceeding. If perforation cannot be ruled out, abandon the
procedure.
Note: Once the heater is activated, the pressure may initially rise 10-20 mmHg; the
pressure may then drop slowly for the remainder of the procedure. The ending
balloon pressure may be as low as approximately 100 mmHg, and is typically
between 120-150 mmHg.
Note: It is recommended that for very small uteri, pressure titration should occur
towards the lower end of the range (i.e. Use a minimum amount of fluid to reach 160
mmHg. This will reduce the potential for increase of pressure during the thermal
treatment that might result in overpressure and system shutdown).
Note: Positioning the device in a false passage may allow the balloon to reach
operating pressure with a small amount of fluid. This may be misinterpreted as being
a small uterine cavity. Care should be taken to insure the device is properly
positioned in the uterine cavity.
Do not over pressurize balloon during titration.
Optimal balloon volume depends on the potential volume of the uterine cavity
and is typically 6-15 ml at >160 mmHg (at start) and may be as great as 30 ml. If
pressure level cannot be reached with 30 ml of fluid, remove balloon catheter and
check for uterine perforation and/or balloon catheter leak. Replace balloon
catheter if necessary.
Page 20
4.0 TREATMENT
4.1 Message Display (alternating):
READY
PRESS START
and
STABILIZE START
PRESSURE >150
When a steady pressure of 160-180 mmHg is maintained, press START (
button on controller to activate the heater.
)
Do not add fluid once heater is activated, as this could create (or exacerbate if
already present) a uterine wall defect such as perforation. Hold the balloon
catheter immobile and centered in the uterine cavity during procedure (with the
valve oriented upwards). Failure to hold the balloon catheter immobile during
procedure can result in catheter failure.
Note: Ensure that the balloon catheter is centered in the uterus to minimize potential
overheat error codes during the treatment process.
4.2 After the start button is pressed, the controller activates the heater to achieve
treatment temperature of 87°C (188°F) within 4 minutes. (This preheat cycle may
take up to 4 minutes for larger uteri, but is usually 15-45 seconds).
PREHEATING
TO 87°C
Note: If the treatment temperature of 87°C is not reached within 4 minutes, the
controller will terminate the procedure. Remove the fluid, remove the catheter.
) button can be
Note: During treatment and in case of emergency, the STOP (
pressed to terminate the procedure. The stop button will power down the heater
and the heater function can only be resumed by turning the unit off and
restarting.
4.3 Message Display:
THERAPY CYCLE
87°C, 8 MIN
Once 87°C is reached, an audible tone will indicate the automatic activation of the 8
minute therapy cycle. The Time elapsed will be shown on the “THERAPY TIME”
display. After the preheat cycle is completed the time resets to 0:00. The displayed
time represents the exact therapy cycle time.
Note: Pressure may rise slightly with initial heating. It is common to then see the
pressure fall gradually during procedure. If the pressure reaches 200 mmHg, an
alarm will sound. If the pressure exceeds 210 mmHg for more than 2 seconds, the
controller will terminate the procedure. The procedure may be restarted with a
lower starting pressure to complete an 8 minute therapy.
Note: A rapid drop in pressure or a failure to maintain pressure may be the result
of a catheter leak or uterine perforation. After sufficient cooling, remove the
balloon catheter. A work-up for perforation should be considered prior to discharge.
GYNECARE THERMACHOICE UBT System Operating Manual
Page 21
Note: Never add additional fluid during a therapy cycle as this could create (or
excerbate if already present) a uterine wall defect such as a perforation.
4.4 When the treatment cycle is completed, the Message Display will alternate
between the following messages:
THERAPY
COMPLETED
and
COOLING DOWN
PLEASE WAIT
4.5 The controller automatically terminates the heater at the end of the treatment
(cycle) and an audible alarm will sound.
5.0 POST-TREATMENT
5.1 The cool down cycle takes 30 seconds. When the cycle is completed, the Message
Display will read the following:
THERAPY & COOL
DOWN COMPLETED
then
REMOVE FLUID
REMOVE CATHETER
Remove fluid by drawing back on syringe while depressing trumpet valve.
Remove all fluid from balloon. Remove the balloon catheter. Check that the entire
fluid volume is withdrawn.
5.2 Disconnect the catheter pressure line from the controller.
5.3 Disconnect the circulation catheter plug, if applicable, from the controller.
5.4 Disconnect the umbilical cable from the catheter (for version 1.2) or from the
catheter umbilical cable connection (for versions 3.0 and 2.0) by pulling back the
gray collar.
5.5 Disconnect the umbilical cable from the controller by holding the stainless steel
ribbed shell and pulling back. Do not pull on the cable itself.
5.6 Discard the catheter. Retain the umbilical cable and disinfect for the next case.
5.7 Power must be turned off before beginning another procedure.
Note: When a controller is left on without use for 8 hours, the controller freezes
and displays the following message:
MAX TIME EXPIRED
TURN POWER OFF
OPERATING PARAMETERS / ALARM AND DISPLAY MESSAGES
The controller is designed to monitor time, temperature and pressure within
parameters present at the factory.
•
•
ALERT. If the temperature and/or pressure increases or falls beyond a level preset
at the factory, the controller will sound a short audible alarm.
HAZARD ALARM/TERMINATION OF PROCEDURE (HEATER SHUT OFF
LIMITS). If the temperature and/or pressure increase or falls outside the
operating parameters, the controller will sound an alarm, terminate the procedure
and display an error message. Additionally, if the controller detects a system
Page 22
failure, the procedure will be terminated. If the procedure is terminated, the
Message Display will display a message indicating the cause.
The following chart explains operating parameters for temperature, time, and pressure:
Standard
Temperature 87°C
Range
75-90°C
Alarm/Heater
Over
Under
Pressure
70-210 mmHg
Titrate to 160-180 mmHg
before starting procedure;
activation pressure
(minimum starting
pressure) >150 mmHg
Time
Shut-off Limits
>95°C for 2 seconds
or between 90-94°C
for 15 seconds
<75°C for 15
seconds*
Over
>210 mmHg for
2 seconds
Under
<70 mmHg for
2 seconds
Over
>4 minute pre-heat
8-minute therapy cycle
after reaching 87°C
(preheat phase)
*or failure to achieve temperature of 87°C within 4-minute preheat phase
When parameters extend outside the normal operating range, the controller sounds an
audible alarm (intended only as a warning signal to the clinician). These values are
listed below and reside between normal operating parameters (see previous chart):
Temperature
Pressure
Over
Under
Over
Under
Alert (Warning)
>90°C & <95°C for 2 seconds
<83°C for 2 seconds
>200 mmHg & <210 mmHg for 2 seconds
>70 mmHg & <100 mmHg for 2 seconds
ERROR MESSAGES
Under electrostatic discharge to the controller or abnormal line voltage conditions,
i.e., surge and fast transients, the system may reset to the initial power-up state. It is
also possible that the unit may terminate the procedure with an error code. In this
case, turn off the power to the controller and restart the procedure.
In addition to the operating messages listed in the "Directions," the message Display
also provides messages which indicate conditions under which the controller either
will not begin treatment or will terminate treatment after the heating cycle has
been initiated.
GYNECARE THERMACHOICE UBT System Operating Manual
Page 23
Prior to pressing START (
) – The following error messages indicate conditions
under which the controller will not begin therapy cycle until corrected:
MESSAGE DISPLAY
CONNECT CATHETER
REASON
Balloon catheter and/or umbilical
ACTION
Connect balloon catheter.
Ensure connections are
secure. Once connected, if
message persists,replace
catheter and/or umbilical
cable.
CATHETER ERROR
REPLACE CATHETER
Balloon catheter and/or umbilical
cable is not functioning properly.
Replace balloon catheter
and/or umbilical cable.
SYSTEM ERROR
TURN POWER OFF
System is not functioning
properly.
Return controller for repair.
After pressing START (
) – The following error messages indicate conditions under
which the controller will terminate the procedure and disable the heating element after
the therapy cycle has begun:
MESSAGE DISPLAY
CATHETER ERROR
END PROCEDURE
REASON
Balloon catheter is not functioning
properly.
ACTION
Remove fluid.
Remove balloon catheter.
SYSTEM ERROR or
HEATER ERROR and
END PROCEDURE
System is not functioning
properly.
Remove fluid.
Remove balloon catheter.
Return controller for repair.
PREHEAT ERROR or
OVERHEAT ERROR or
UNDERHEAT ERROR or
PRESSURE ERROR and
END PROCEDURE
Treatment temperature and/or
pressure is outside standard
operating parameters.
Remove fluid.
Remove balloon catheter.
WARRANTY
GYNECARE, a Division of ETHICON, INC., warrants to the original purchaser of the
GYNECARE THERMACHOICE UBT System Controller that it shall be free of defects
in material and workmanship when used as intended under normal surgical
conditions and in conformance with its directions for use and maintenance
instructions. The obligation of GYNECARE under this warranty shall be limited to the
repair or replacement, each at no charge, at the option of GYNECARE within one year
from the date of purchase, if examination shall disclose to the satisfaction of
GYNECARE that the controller does not meet this warranty.
THIS WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED
OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR USE AND ALL OTHER OBLIGATIONS AND LIABILITIES ON THE
PART OF GYNECARE. GYNECARE NEITHER ASSUMES NOR AUTHORIZES ANY
OTHER PERSON TO ASSUME FOR IT, ANY OTHER LIABILITY IN CONNECTION
WITH THE SALE OF A GYNECARE CONTROLLER. THIS WARRANTY SHALL NOT
APPLY TO A GYNECARE CONTROLLER OR ANY PART THEREOF WHICH HAS
BEEN SUBJECT TO ACCIDENT, NEGLIGENCE, ALTERATION, ABUSE, OR MISUSE,
NOR TO ANY GYNECARE CONTROLLER THAT HAS BEEN REPAIRED OR
ALTERED BY ANYONE OTHER THAN AN AUTHORIZED GYNECARE SERVICE
PERSON. GYNECARE MAKES NO WARRANTY WHATSOEVER WITH REGARD TO
Page 24
ACCESSORIES OR PARTS USED IN CONJUNCTION WITH THE GYNECARE
CONTROLLER AND NOT SUPPLIED AND MANUFACTURED OR INSTALLED BY
GYNECARE THE TERM "ORIGINAL PURCHASER", AS USED IN THE WARRANTY,
SHALL BE DEEMED TO MEAN THAT PERSON OR ORGANIZATION AND ITS
EMPLOYEES, IF APPLICABLE, TO WHOM THE GYNECARE CONTROLLER WAS
SOLD BY GYNECARE THIS WARRANTY MAY NOT BE ASSIGNED OR
TRANSFERRED IN ANY MANNER.
GYNECARE shall in no event be liable for any special, indirect or consequential
damages of any kind and however caused arising from the sale or use of the
UBT system.
Should any GYNECARE controller become inoperable after the one year period of this
Warranty or should damage occur which is not covered under the terms of this
Warranty, GYNECARE will, upon request, repair the controller, if possible, for an
appropriate handling and repair charge.
SERVICING / EQUIPMENT DISPOSAL
Should the GYNECARE THERMACHOICE UBT System controller become
inoperable, contact your local sales representative. Clean and repackage the controller
appropriately and return it for repair, servicing and/or modification to JaBil Global
Services Inc., 11201 Electron Drive, Louisville, KY 40299 (US customers only) or your
local GYNECARE authorized service center. If the controller is not under warranty, an
appropriate handling and repair charge will be established after receipt and
examination of the controller.
Note: The GYNECARE THERMACHOICE UBT System controller contains electronic
printed circuit assemblies. At the end of the useful life of the equipment, it should be
disposed of in accordance to any applicable national or institution related policy
relating to obsolete electronic equipment.
Note: Dispose of any system accessories according to normal institution practice
relating to potentially contaminated items.
Note: Any device related incident or problems which are felt to represent a safety
issue should be reported by calling GYNECARE at 1-877-ETHICON.
ORDERING INFORMATION
For ordering information call 800-255-2500.
SPECIFICATIONS (CONTROLLER & UMBILICAL CABLE)
POWER SOURCE (Controller)
Power Requirements............................100 to 240 VAC; 50/60 Hz; 110 watts; 3-wire
grounded system
Regulation Voltage ..............................90 to 264 VAC, 47-63 Hz, single phase
Mains Fuses ..........................................250 VAC, 5 x 20 mm 1.6 A standard
MECHANICAL CHARACTERISTICS
Dimensions............................................Height 10.2 cm (4 in.), width 41.2 cm (16.25 in.),
depth 37.0 cm (14.56 in.)
Weight ....................................................6.9 kg (15.3 lbs) (controller only)
Case ........................................................Aluminum and impact-resistant plastic
Umbilical Cable ....................................Length 152 cm (60 in.)
GYNECARE THERMACHOICE UBT System Operating Manual
Page 25
ENVIRONMENTAL CONDITIONS
Transport and Storage
Ambient temperature ..........................-20 to +50°C
Relative humidity ................................20% to 85% non-condensing
Operation
Ambient temperature ..........................10 - 40°C
Relative humidity ................................20% to 85% non-condensing
Electromagnetic Compatibility
ESD ........................................................Direct & Indirect: Conforms to IEC 601-1-2
EMI ........................................................Conforms to IEC 601-1-2
Leakage Currents
Patient Leakage Current......................Conforms to IEC 601-1
Earth Leakage Current ........................Conforms to IEC 601-1
ELECTROMAGNETIC INTERFERENCE
In general, sensitive electronic equipment should always be positioned as far away as
possible from sources of high frequency voltages and currents, such as electrosurgical
generators. Moreover, cables connected to high frequency sources should be kept as
short as possible and must never be routed near or parallel to cables of sensitive
equipment.
MAINTENANCE
1.0 CALIBRATION
Every time the GYNECARE THERMACHOICE UBT System is powered up, the
controller checks the calibration of the temperature circuitry. The pressure
measurement in the system is accomplished by utilizing two transducers. These
transducers are internally calibrated and are temperature compensated which are
accurate and stable over the operating range. They are also factory calibrated at
installation. These pressure readings are checked against each other at power up
and throughout the procedure. These sensors are of differential type, and
therefore measure the balloon pressure relative to the outside atmosphere. In
addition to the internal means of calibration, it is possible to ensure the proper
operation of the system against other calibrated devices. The procedure is
recommended to be performed on an annual basis. The procedure also needs to be
carried out if it is believed that the system is behaving unexpectedly.
Note: There are no calibration adjustments on the controller. If the unit does not
meet the calibration requirements, it needs to be sent back to the manufacturer.
1.1 PRESSURE CALIBRATION
1.1.1
Equipment List
The following equipment list or equivalent is needed to perform the procedure:
1.
Pressure meter: DigiMano model DPM 2000PS. NETECH Corporation, 60
Bethpage Drive, Hicksville, NY 11801, Telephone: (800) 547-6557/(Any
calibrated NBS traceable pressure gauge with a range of at least +6 psi can
be used).
2. Syringe: PN 3099650, Becton-Dickinson, McKesson General Medical, 4501 Pell
Drive, Sacramento, CA 95838, Telephone: (800) 366-8990.
Page 26
3.
4.
5.
6.
Trumpet valve: PN S5402601, Braun Medical, Inc., 824 Twelfth Ave., PO Box
027, Bethlehem, PA 18018-0027, Telephone: (800) 227-2862.
T connector: PN T20-1, Value Plastics, Inc., 3350 Eastbrook Dr., Fort Collins,
CO 80525, Telephone: (970) 223-8306.
Tubing: 0.093 ID, 0.156 OD, Norton Performance Plastics Corp, PO Box 660,
Akron, OH 44309-3660, Telephone: (800) 798-1539.
Male luer lock adapter: PN B0850402, Braun Medical, Inc., 824 Twelfth Ave.,
PO Box 4027, Bethlehem, PA 18018-0027, Telephone: (800) 227-2862.
Diagram 6
Syringe
Trumpet valve
1.1.2
Male luer lock adapter
T-Connector
Pressure
gauge
Procedure
1.
With no attachments to the luer lock, apply power to the controller. The
pressure display should read 0+10 mmHg.
2. Assemble the digital pressure gauge, the tubing, the T connector, the trumpet
valve, the male luer lock adapter, and the syringe as shown in Diagram 6, and
connect to the connection port (luer lock) of the controller.
3. While depressing the trumpet valve, apply vacuum to the system using the
syringe until the gauge reads approximately –250 mmHg.
4. Release the trumpet valve. The controller pressure reading should be within
+10 mmHg of the gauge reading
5. While depressing the trumpet valve, apply pressure to the system until the
reading on the digital display meter indicates a pressure of approximately
250 mmHg.
6. Release the trumpet valve. The controller pressure reading should be within
+10 mmHg of the gauge reading.
1.2 TEMPERATURE CALIBRATION
1.
2.
3.
4.
5.
Obtain a calibrated digital or glass thermometer.
Place this thermometer in close proximity to a new GYNECARE
THERMACHOICE UBT catheter tip and allow them to come to thermal
equilibrium with the ambient.
Connect the catheter to the controller using the umbilical cable as described
earlier in the manual.
Power up the controller.
Note the thermometer reading and compare to that of the controller. The
readings should be within +5 degrees Celsius.
GYNECARE THERMACHOICE UBT System Operating Manual
Page 27
6.
Insert the balloon end of the catheter along with the thermometer in
80-90 degrees Celsius water.
7. Allow a few minutes for the catheter and the thermometer to come to
thermal equilibrium.
8. Compare the two temperature readings. They should be within +5 degrees
Celsius.
2.0 FUSE REPLACEMENT
Fuse: In the event of a main fuse failure, turn off the power and unplug the rear
of the controller to allow fuse access. Using a tool such as a screwdriver, remove
the fuse drawer by depressing the locking tab. See Diagram 7 below:
Diagram 7
Mains Fuse Drawer
Use a tool to depress
the locking tab
Mains Fuse
type and rating
Replace both fuses with the same type and rating as specified on the rear of the
controller. Reinsert the fuse drawer until the locking tab snaps into place.
Reconnect the power cord and restore power to the controller. If a fuse fails again,
disconnect all power to the controller and return it to GYNECARE.
All other service must be performed by appropriately qualified technical
personnel. Field repair, other than the controller’s external fuse replacement, voids
all warranties and may not be performed without express authorization from
GYNECARE.
3.0 CLEANING: CONTROLLER SYSTEM
It is good practice to routinely clean the exterior surface of the device.
1. Disconnect all umbilical cables and unplug the power cord from the wall
outlet before cleaning.
2. Use a cloth dampened with 50% water and 50% isopropyl alcohol, or a mild,
nonabrasive detergent (such as commercially available dish cleaning liquid)
mixed with water.
3. Periodically clean the entrance of the controller’s port (luer lock) using a
cotton swab with 50% isopropyl alcohol.
Do not autoclave, ETO sterilize, or immerse the controller or umbilical cable in
a liquid. Do not allow liquids to enter the controller during cleaning.
Page 28
4.0 DISINFECTION: UMBILICAL CABLE
The GYNECARE THERMACHOICE UBT umbilical cable is packaged non-sterile.
After each use, the cable should be disinfected. To disinfect, wipe down the cable
with a damp cloth using a solution of 50% water and 50% isopropyl alcohol. Use
only 50% water and 50% isopropyl alcohol. Ensure the cable and connectors are
completely dry. Inspect the cable and the connector plugs before each use for
signs of wear and replace if necessary. The umbilical has been validated for 20
cycles. Following 20 uses, discard the cable, and replace.
5.0 POWER CORD
Users in North America operating from a nominal 120 VAC system must select a
Type SJT, SJTO, SJO, or SJE, Hospital Grade cord set. The power supply cord must be
marked "Grounding Reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked ‘Hospital Grade’ or ‘Hospital Only.’"
GYNECARE THERMACHOICE UBT System Operating Manual
Page 29
Error Code Table
ERROR
CODE
01
DISPLAYED
TEXT
SYSTEM ERR01XX
TURN POWER OFF
02
REASON
Controller malfunction
ACTION
Turn power switch off
and REMOVE
CATHETER then on
again. If error message
persists,return to
GYNECARE for service.
SYSTEM ERR02XX
TURN POWER OFF
Controller malfunction
Turn power switch off
and then on again. If
error message
persists,return
controller to
GYNECARE for service.
03
SYSTEM ERR03XX
TURN POWER OFF
Controller malfunction
Turn power switch off
and then on again. If
error message Gynecare
for service. persists,
return controller to
GYNECARE for service.
50
CATHETER ERR50XX
REPLACE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to clear
error message and
replace catheter.
51
CATHETER ERR51XX
REPLACE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to clear
error message and
replace catheter.
52
CATHETER ERR52XX
REPLACE CATHETER
——————————
REMOVE FLUID
REMOVE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to clear
error message and
replace catheter.
53
OVERHEAT ERR53XX
END PROCEDURE
Fluid temperature
between 90 °C
95 °C for 15 seconds.
Return controller to
GYNECARE and for
service.
54
CATHETER ERR54XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature
>95 °C for 2 seconds.
Return controller to
GYNECARE for service.
55
CATHETER ERR55XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to
clear error message and
replace catheter.
Page 30
Error Code Table
56
CATHETER ERR56XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to clear
error message and
replace catheter.
57
CATHETER ERR57XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to clear
error message and
replace catheter.
58
CATHETER ERR58XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Catheter malfunction
Possible catheter
failure.
Turn power off to clear
error message and
replace catheter.
59
OVERHEAT ERR59XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature
between 90 °C and 95 °C
for 15 seconds.
Return controller to
GYNECARE for service.
60
OVERHEAT ERR60XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature
>95 °C for 2 seconds.
Return controller to
GYNECARE for service.
61
OVERHEAT ERR61XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature
>105 °C for 2 seconds.
Return controller to
GYNECARE for service.
62
PRESSURE ERR62XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Under-pressure:
Possible catheter
failure -leak.
Turn power off to
clear error
PRESSURE ERR63XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Over-pressure:
64
HEATER ERR64XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature
<87 °C during entire
4 minute preheat cycle.
Return controller to
GYNECARE for service.
65
HEATER ERR65XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Catheter malfunction
Possible catheter
failure. Turn power off
to clear error message
and replace catheter.
63
Pressure <70 mmHg
for 2 seconds.
Turn power off to clear
error.
Pressure >210 mmHg
for 2 seconds.
GYNECARE THERMACHOICE II System Operating Manual
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Error Code Table
66
UNDERHEAT ERR66XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature
<75 °C for 15 seconds.
Return controller to
GYNECARE for service.
67
UNDERHEAT ERR67XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Pressure transducer
Return controller to
GYNECARE for service.
68
CATHETER ERR68XX
END PROCEDURE
——————————
REMOVE FLUID
REMOVE CATHETER
Fluid temperature did
not rise ~6 °C within
30 seconds.
Possible catheter
failure.Turn power off to
and replace catheter.
clear error message
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GYNECARE THERMACHOICE II System Operating Manual
Page 33
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