LS2101 Instructions for Use (IFU)_F

Instructions for Use
LS2101 Rev C
1
Contents
English
(EN)
3
German
(DE)
18
33
Italian
(IT)
49
Spanish
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65
Dutch
(NL)
81
Swedish
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97
Danish
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112
Finnish
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2
EN
EN
Instructions for Use
Only medical professionals who have experience in performing
procedures within the uterine cavity, such as IUD insertions or dilation
and curettage, are suitably trained, have adequate knowledge and
familiarity with the Thermablate EAS system, should perform
endometrial ablation using this device.
Read all directions, cautions, and warnings prior to use. These
Instructions for Use provide directions for using the Thermablate EAS
system.
Failure to follow any instructions or to heed any warnings or
precautions could result in serious injury to the patient.
These Instructions for Use are complemented and reiterated by the
“Operator’s Manual” included with the Treatment Control Unit (TCU) kit.
Use caution not to perforate the uterine wall during dilation, sounding,
or cutterage (if performed). If a perforation is suspected, a
hysteroscopy must be performed. Do not initiate the procedure if
perforation of the uterine wall or the creation of a false passage is
confirmed during the hysteroscopy performed just prior to the insertion
of the balloon.
Do not perform same day Thermablate EAS procedure and hysteroscopic tubal
occlusion/sterilization.
Thermablate EAS procedure can be safely and effectively performed with nickel
titanium inserts in place, however the procedure should only be performed after
the 3 month tubal occlusion confirmation test.
The outside temperature measured on the disposable cartridge sheath can
reach a maximum of 80°C during treatment cycle. It has been confirmed from
clinical studies and historical data, that the heat lacks sufficient energy to cause
any heat transfer to surrounding area.
To eliminate any potential for patient discomfort in some circumstances Medical
Equipment should not to be placed against exposed flesh during treatment
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PATIENT SELECTION
Excessive uterine bleeding can be caused by a variety of underlying problems
including but not limited to endometrial cancer, myomas, polyps, and drugs.
Patients should always be evaluated to determine if there are underlying
causes of their excessive uterine bleeding before any treatment option is
initiated.
The patient selection criteria are:
•
•
•
•
•
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Documented diagnosis of excessive uterine bleeding with no
underlying causes
Completed childbearing
Pre-menopausal
Normal uterine cavity with sounding between 8 cm and 12 cm,
inclusive
Normal Pap Smear and endometrial biopsy
Does not present any of the contraindications below.
CONTRAINDICATIONS
Thermablate EAS is contraindicated for use in:
•
A patient with a uterine sounding less than 8 cm or in excess of
12cm (external os to fundus)
•
A patient with active pelvic inflammatory disease
•
A patient with known or suspected endometrial carcinoma
(uterine cancer) or pre-malignant change of the endometrium,
such as unresolved complex (adenomatous) hyperplasia
•
A patient with history of pelvic malignancy within the past 5
years.
•
A patient with submucous / intramural myomas greater than 3.0
cm such that the uterine cavity is significantly distorted
•
A patient with intracavitary lesions (Type 0 or 1 myoma or
polyps of any size) as documented by hysteroscopy, saline
infusion sonohysterogram (SIS), or MRI performed in the last
six months. Ablation can be performed if polyp is removed prior
to procedure.
•
A patient with a septate uterus
•
•
•
•
•
•
A patient with an IUD currently in place
A patient with any anatomic or pathologic condition in which
weakness of the myometrium could exist, such as history of
previous classical caesarean section or transmural
myomectomy
A patient that has had three or more, lower segment C
sections and where the linear scar thickness in those patients
is less than 8mm.
A patient who is pregnant or who wants to become pregnant in
the future
A patient with active genital or urinary tract infection at the time
of procedure (e.g. cervicitis, vaginitis, endometritis, salpingitis,
or cystitis)
A patient less than 6 months post-partum.
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REPEAT BALLOON ABLATIONS ARE CONTRAINDICATED
As the endometrial cavity following any kind of endometrial ablation is
most likely distorted, repeat ablations should not be attempted with
Thermablate EAS. Patients requiring further treatment after thermal
balloon ablation should be treated medically, by resectoscopic
endometrial ablation, or by hysterectomy. Repeat resectoscopic ablation
resection should be attempted only by experienced hysteroscopists since
the complications may be severe.
POTENTIAL ADVERSE EVENTS
The following adverse events are potentially associated with endometrial
ablation:
•
Pelvic cramping
•
Nausea and vomiting
•
Perforation of the uterus
•
Rupture of the uterus
•
Thermal injury to adjacent tissues/organs
•
Heated liquid escaping into the cervix, vagina, or fallopian
tubes
•
Infection
•
Post-ablation tubal sterilization syndrome (PATSS)
•
Hematometra.
RECOMMENDED PRE-TREATMENT OF ENDOMETRIUM
•
Oral Contraceptives (Recommended for minimum 21 days until
day of treatment)
•
NuvaRing®
•
Timing of the Menstrual Cycle
•
Suction Curettage (If necessary)
•
GnRH analogues recommended only for patients with a uterine
sounding ≥ 10 cm.
PATIENT COUNSELLING
As with any procedure, the physician needs to discuss the risks, benefits, and
alternatives with the patient prior to performing endometrial ablation.
The device is intended for use in women who do not desire to bear children
because the likelihood of pregnancy is significantly decreased following this
procedure.
Patients of childbearing capability should be counselled that endometrial
ablation is not a sterilization procedure and should be provided with an
appropriate birth control method. These patients should be cautioned of the
potential complications that 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; serosanguineous by
approximately one week; then profuse and watery thereafter. Excessive pain,
heavy bleeding, foul smelling discharge or fever should be reported to the
physician.
WARNING
Endometrial ablation using the Thermablate EAS system is not a
sterilization procedure. Pregnancies after ablation can be dangerous
for both mother and foetus.
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Directions for Use
SET-UP
1. Check that the following items are present with the Thermablate
EAS device:
• One (1) Sterile Disposable (Single-Use) Cartridge
• One (1) Treatment Control Unit (TCU)
• One (1) Universal-Input Power Supply
• One (1) Power Cord (to match local AC power receptacles)
• One (1) TCU Stand.
Frequently Used Functions
Operator should make themselves aware of the following functions:
On / Off Power switch located on power cord into TCU
Emergence Stop Button located on LCD overlay on top of TCU.
Blue Treatment Trigger Switch located on front of the TCU handle.
2. Place TCU in Stand.
3. Ensure the “POWER SWITCH” is in the “OFF” position.
4. Connect the Power Supply to the TCU. Plug the Power Cord into
both the Power Supply and the wall power outlet. Ensure that all
the connections are firmly connected. Ensure that the “POWER
SWITCH” and mains plug can be easily accessed to disconnect
power to the TCU.
5. Ensure that the device is positioned to allow ease of access to the
patient during treatment avoiding any hinderances, stretching or
obstructions. Also ensure that no cables or accessories are placed
in a dangerous manner or position.
OPENING AND INSTALLING THE THERMABLATE EAS STERILE
DISPOSABLE CARTRIDGE
1. The Disposable Cartridge is inside a pouch (Pouch made of clear film
and Tyvek webs). The pouch is inside a tube with lids. The tube is
inside a foil vacuum bag designed to be peeled open. ONLY THE
CONTENTS OF THE FOIL BAG ARE DEEMED TO BE IN A
STERILE STATE. The foil vacuum bag is inside a cardboard box.
2. Check expiry date. DO NOT USE the Disposable Cartridge if it has
expired.
3. Open cardboard box.
4. Remove foil vacuum bag from cardboard box.
5. Ensure vacuum is intact. If it is not, DO NOT USE the Disposable
Cartridge. get another Disposable Cartridge instead.
6. Peel open foil vacuum bag.
7. Remove tube from the foil vacuum bag. Do not discard plastic tube but
place aside for use in safe disposal of disposable cartridge after use.
8. Remove the lid with
label attached from the tube by tearing
the blue cap where indictaed by the symbol.
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9. Remove pouch containing the disposable cartridge.Peel open pouch
to remove cartridge using standard aseptic technique.
10. Install Disposable Cartridge in the TCU, by lining up the 2 pins on the
cartridge with the 2 slots in the TCU, and rotating it clockwise, as
shown in the figure below. Ensure that “THIS SIDE UP” and the
guidance markings are visible on the top side of the catheter. Leave
the plastic balloon cover on.
WARM-UP
1. Turn the “POWER SWITCH” to the “ON” position; the LCD will show
the following message: If no display is present then do not continue
with procedure.
WELCOME TO
THERMABLATE
Both LED’s should be OFF (see below right-bottom corner of LCD).
(If the number of treatments remaining before servicing is less than
50, the TCU will issue a beeping sound and the LCD will show the
following message for 10 seconds:
X TREATMENT(S)
BEFORE SERVICING
where “X” is number of remaining uses of the TCU.)
2. The unit automatically performs a self-test, and, if no technical
problems are encountered, the initial message is replaced by the
following message:
Device OK
(If the TCU encounters a technical problem, an error number will be
displayed on the LCD. Please refer to the Operator’s Manual for
troubleshooting.)
3. The following message is then displayed:
HEATING – Wait…
Fluid Temp XXX °C
where “XXX” is the measured temperature of the treatment liquid.
The “Heating” LED will turn ON, indicating that the pre-heating of the
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treatment liquid has begun. The “Ready” LED should be OFF. Before
entering the “READY FOR TREATMENT” state the TCU performs a
leak test. If this test is not passed (“ERROR #19” will appear on LCD),
turn the “POWER SWITCH” to the “OFF” position, and verify that:
A) The Disposable Cartridge has been installed properly into the
TCU, and
B) No fluid is leaking out from the Disposable Cartridge, particularly
from the balloon.
In case of a leaking Disposable Cartridge that has not spilled
treatment fluid into the TCU, replace with a new one. USE EXTRA
CAUTION, AS THE METALLIC PART OF THE DISPOSABLE
CARTRIDGE MAY BE VERY HOT.
Turn the “POWER SWITCH” back to the “ON” position.Wait until the
TCU reaches the “READY FOR TREATMENT” state.
If treatment fluid has leaked into the TCU, it will need to be repaired.
PATIENT PREPARATION
1. Provide patient with adequate analgesia.
2. During and/or prior to the pre-heating of the treatment fluid, patient
preparation can be performed. Appropriate sterile technique for
vaginal/cervical preparation should be used.
3. Place patient in dorsal lithotomy position.
TREATMENT
After approximately 12 minutes, the LCD will show ”READY FOR
TREATMENT” (see below) and the TCU will beep, indicating that the
fluid has been heated up to treatment temperature (approximately
173°C) and the treatment procedure can be initiated. The “Heating”
LED turns OFF and the “Ready” LED turns ON. The LCD Display
reads:
READY
FOR TREATMENT
NOTICE
If the system is left unused, the treatment temperature will be
maintained for 35 minutes. After this period, the system will
automatically turn OFF. To reinitiate Warm-Up, turn the "POWER
SWITCH” to the “OFF” position, and restart the process.
The Disposable Cartridge must not be used if it has been heated
up and cooled down more than twice or exposed to ambient air
for more than 2 hours.
WARNING
IF THE BALLOON IS NOT COMPLETELY DEFLATED AND
LIQUID AND / OR GAS IS SEEN IN BALLOON DURING
“READY FOR TREATMENT” STATE, DO NOT PROCEED
WITH THE TREATMENT. Instead, turn the “POWER
SWITCH” to the “OFF” position, disconnect the power cord,
substitute the Disposable Cartridge, and restart the process.
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WARNING
IF THE BALLOON COVER CANNOT BE EASILY REMOVED
FROM THE BALLOON, DUE TO PRESSURE IN THE
BALLOON, DO NOT DETACH CARTRIDGE FROM TCU.
Instead, turn the “POWER SWITCH” to the “OFF” position,
disconnect the power cord and cool down both TCU and
Cartridge together until Balloon Cover can be easily removed.
Remove Cartridge carefully from TCU, verify no fluid leaking out
to the TCU, substitute the Disposable Cartridge, and restart the
process.
CAUTION
Patients with either an acutely anteverted or retroverted
uterus, or a fixed uterus (e.g. due to significant
endometriosis or adhesions), or those that have had
previous uterine surgery are at a higher risk. Particular
attention should be paid to the angulation of the uterine
sound, cervical dilator and Thermablate catheter during
insertion.
1. Conduct pelvic examination to confirm position of uterus.
2. Insert Speculum.
3. Apply tenaculum.
4. Measure sounding length of uterus from external os to fundus using
uterine sound. Confirm that measurement is between eight (8) and
twelve (12) cm.
5. Use dilators to gradually dilate cervix up to seven (7) mm. Dilators
should pass easily through cervix with minimal discomfort to the
patient. Dilators should not be advanced deeper than the
predetermined uterine depth.
6. Measure length of uterus a second time using the uterine sound.
Confirm that sounding length of the uterus after dilation is the same as
sounding length obtained prior to dilation. If there is a discrepancy of
more than 0.5cm between the first and second measurements a false
passage or perforation of the uterus may have been created during the
dilation.
7. Perform hysteroscopy prior to balloon insertion to ensure that
the uterus has not been perforated or that a false passage has
not been created during dilatation, sounding or curettage (if
performed).
CAUTION
A PERFORATION OF THE UTERUS OR CREATION OF A FALSE
PASSAGE, IF UNDETECTED, CAN LEAD TO THERMAL
INJURIES OF ADJACENT ORGANS OR TISSUE
Hysteroscopy should reveal both tubal ostia clearly before
proceeding with the treatment. If distension of uterus during
hysteroscopy cannot be maintained, it is possible that the uterus
has been perforated and treatment should not proceed.
Should the hysteroscopy reveal an excessively thick endometrial
lining, a gentle suction curettage of the uterus may be performed.
9
A second hysteroscopy should be performed immediately
following curettage to ensure that the curettage has not created a
perforation of the uterus.
8. Alternatively, use ultrasonic surveillance during the treatment to check
for correct balloon position inside the uterine cavity.
9. Slide the balloon cover off the balloon. DO NOT DISPOSE OF
BALLOON COVER AS IT IS REQUIRED FOR LATER USE.
Remove the Thermablate EAS system from the TCU Stand.
10. Slowly insert the Thermablate balloon until balloon tip touches the
fundus. Tap the tip of catheter gently against the fundus to confirm
placement of the catheter within the uterus.
11. Ensure that the depth marking on the balloon catheter matches the
previously obtained sounding measurements. Should there be a
discrepancy of more than 0.5 cm between the sounding
measurements obtained and depth marking on the catheter, a repeat
hysteroscopy should be performed.
12. Activate the treatment cycle by holding Blue Treatment Trigger
Switch for 5 seconds. After hearing five (5) short and one (1) long
beeping sounds, the treatment will automatically begin. The Finger
can be removed from the trigger switch at this point. The LCD will
show the following message:
Performing
System Check
Both LEDs will turn OFF.
13. After 15 seconds, if the TCU passes the system check, the actual
treatment cycle will start, and the LCD will show the following
message:
TREATING…
Starting…
Followed shortly after by:
Pressure: XYYY
Time Left: Z:ZZ
where “X” is the sign (+ or -) for positive or negative pressure.
“YYY” is the actual pressure value reached during
procedure (mmHg).
“Z:ZZ” is the treatment time remaining (min:sec).
If the system check fails, the TCU will issue an alarm and
stop operating. In this case, turn the “POWER SWITCH” to
the “OFF” position, d i s c o n n e c t t h e p o w e r c o r d ,
a n d remove the Disposable Cartridge from the patient,
and verify that:
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A) The Disposable Cartridge has been installed properly into the
TCU, and
B) No fluid is leaking out from the Disposable Cartridge, particularly
from the balloon.
In case of a leaking Disposable Cartridge that has not spilled treatment
fluid into the TCU, replace with a new one. USE EXTRA CAUTION, AS
THE METALLIC PART OF THE DISPOSABLE CARTRIDGE MAY BE
VERY HOT.
Turn the “POWER SWITCH” back to the “ON” position and follow the
instructions until reaching the system check.
If treatment fluid has leaked into the TCU, it will need to be repaired.
14. As the balloon deploys, it may push the catheter slightly backwards
(Up to 0.5 cm is normal). Do not push the catheter forward during
treatment.
CAUTION
At no time during the treatment should the catheter advance
beyond the pre-determined sounding length. Should this occur,
abort the procedure by activating the “Emergency Stop”button,
observe the “Treatment Stop” message, while the fluid is
actively withdrawn from the balloon and wait for the
message: “Finished V: XX ml Withdraw Balloon” to appear on
the LCD screen and slowly remove the Thermablate catheter
from the uterus. Perform a hysteroscopy to ensure that the
uterus has not been perforated.
15. Observe the LCD screen on TCU as it automatically performs
system checks and completes the treatment cycle.
Automatic operation of the System inflates the balloon, controls
the pressure, and pulses the treatment liquid, maintaining uniform
temperature in the balloon. During this time, the pump is clearly
audible. This is not a malfunction – it is part of the normal
operation of the unit.
CAUTION
IN THE EVENT OF POWER LOSS DURING TREATMENT
If the power is lost during treatment, wait for thirty (30) seconds. If,
after this 30-second period, the power has not come on again,
withdraw the balloon fast but carefully since some liquid may still be
contained in the balloon. Turn the “POWER SWITCH” to the “OFF”
position, and then go to Section “Post-Treatment” below.
If the power has come on again within this 30-second period, DO
NOT WITHDRAW THE BALLOON. The TCU will automatically
recognize that the “previous” treatment did not finish correctly and
will proceed to actively withdraw the liquid from the balloon.
REMOVE THE BALLOON FROM THE UTERUS ONLY AFTER THE
“FINISHED V: XX ml Withdraw Balloon” MESSAGE APPEARS
ON THE LCD SCREEN.
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EMERGENCY INTERUPTION / TERMINATION OF TREATMENT
IF EMERGENCY INTERRUPTION / TERMINATION OF TREATMENT IS
REQUIRED OR IF LIQUID IS NOTED LEAKING THROUGH THE CERVIX,
DO NOT IMMEDIATELY REMOVE THE BALLOON FROM THE UTERUS.
If fitted, first, activate the red “Emergency Stop” button on the LCD
overlay which will activate the emergency routine and display
“TREATMENT STOP” message on the LCD and proceed to actively
withdraw the liquid from the balloon.
OR
Turn off the power to the TCU. Then proceed to turn power back on to
the TCU. In doing so, the TCU will automatically recognise that the
“previous” treatment did not finish correctly. The TCU will display the
“TREATMENT STOP” message on the LCD and then proceed to actively
withdraw the liquid from the balloon.
TREATMENT STOP
Do NOT Remove
REMOVE THE BALLOON FROM THE UTERUS ONLY AFTER
“FINISHED V: XX ml Withdraw Balloon” MESSAGE APPEARS ON
THE LCD SCREEN.
.
WARNING
If the TCU encounters a technical problem during the procedure, it
will issue a “TREATMENT FAILED” message. REMOVE THE
BALLOON FROM THE UTERUS ONLY AFTER THE
“FINISHED V: XX ml Withdraw Balloon” MESSAGE APPEARS
ON THE LCD SCREEN.
16. After completion of the treatment cycle, the LCD will show the
following message:
FINISHING…
Do NOT Remove
WARNING
If the TCU encounters a technical problem during the deflation
procedure, it will issue a “DEFLATION FAILED” message. DO NOT
REMOVE THE BALLOON FROM THE UTERUS. Instead, wait until
the device withdraws the liquid from the balloon. REMOVE THE
BALLOON FROM THE UTERUS ONLY AFTER THE
“FINISHED V: XX ml Withdraw Balloon” MESSAGE APPEARS
ON THE LCD SCREEN.
17. After 10 seconds of deflation time, the LCD will show the following
message
FINISHED V: XX ml
Withdraw Balloon
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where “XX” is the estimated uterus volume.
This message indicates that the treatment is complete and that the
balloon can be withdrawn. Withdraw the balloon carefully from the
uterus.
After evert treatment the TCU carries out a test on the Filter Quality
and if it has deteriorated beyond a set point the following message
will be displayed along with an audible indication.
Filter Change is
Due Right NOW
If this message is displayed the TCU MUST be returned for IMMEDIATE
Servicing.
POST-TREATMENT
1. Place the TCU in the TCU Stand. REPLACE BALLOON COVER ONTO
THE BALLOON (To prevent blood splatter during disposal of cartridge).
2. After 50 seconds, the TCU will beep and its LCD will alternate the
two following messages, continuously:
DISCARD
USED CARTRIDGE
***WARNING***
*Metal End *HOT*
3. Turn the “POWER SWITCH” to the “OFF” position.
WARNING
The Disposable Cartridge IS HOT and should be removed from the
TCU and returned into the tube carefully.
4. Remove Disposable Cartridge from TCU.
5. Return the Disposable Cartridge into its original tube by holding the
blue connector and inserting ALLUMINIMUM SHIELD END FIRST (so
that the hot metal end of the cartridge will be toward the metal
reinforced cap) and cover with the capcontaining holes. Allow it
to cool, and dispose of it in biohazard-labelled containers or per
facility policy.
WARNING
The Disposable Cartridge is a SINGLE-USE component. Do not
reuse it as this could result in serious injuries to the patient
and/or the user.
6. Post-treatment hysteroscopy is recommended.
7. Repeat balloon ablations are contraindicated.
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CLEANING, MAINTENANCE, AND STORAGE
CLEANING
After each use, the TCU must be cleaned according to the following
procedure:
1. D i s c o n n e c t t h e T C U f r o m t h e P o w e r s u p p l y .
2. Wipe down the outside of the TCU housing with warm water
using a soft bristle brush until no soilage can be seen.DO
NOT SOAK OR IMMERSE.
3. Subsequently, wipe down the outside of the TCU housing with warm water
using a clean wipe.DO NOT SOAK OR IMMERSE
4. Disinfect the outside of the TCU housing with a clean wipe and
50%IPA/water solution. DO NOT SOAK OR IMMERSE
CAUTION
This unit contains electronic components. DO NOT soak, flush,
spray or use excessive free liquid on the TCU
MAINTENANCE
There are no user serviceable parts within the TCU. Opening the
device will void the warranty. Return unit to Idoman for service or
repair.
It is recommended that the TCU and its accompanying power supply are
subjected to annual inspection to ensure the safety of the device for both
patient and user.
This inspection should include the following:
• Power connecting cords and power supply for signs of damage or wear.
• TCU housing for signs of damage which may leave it in an unsafe or
contaminated state.
• Presence and legibility of all Safety related markings and Labels.
• Copy of Equipment Operators manual present.
Testing (If Required)
• Protective earth resistance
• Equipment leakage current
• Patient leakage current
• Insulation resistance.
• Functional Test of Device
WARNING
No modification of this equipment is allowed. Unauthorised modifications
or access may result in electrical shock or leave the unit in a hazardous
condition.
All TCU units that have reached their end of service life should be returned to
manufacturer for disposable as per WEEE Directive 2002/96/EC
STORAGE
1. Store the TCU in the Carrying Case. The storage temperature should
never exceed 50°C.
2. Store Disposable Cartridge in dry place at room temperature.
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SYMBOLS USED ON LABELLING
Method of Sterilization – Gamma
Irradiation
Do not reuse
Do not resterilize
Read Instruction / Operators
Manual
Caution – Hot Surface
Latex-free
Expiry date
Classification according to the degree
of protection against electric shock:
Type BF
Date of Manufacture
Do Not Use If Package Is Damaged
Fragile, Handle with Care
Keep Dry
Correct Upright Position
Humidity Limitation
15
Atmospheric Pressure Limitation
On position of power switch
Off position of power switch
Class II
Method of protection against electric shock
Product must be disposed of as per
WEEE Directive 2002/96/EC
Power Supply RoHS Compliant
Power Supply Green Energy Level Rating
0120
CE Mark and Identification Number
of Notified Body. Product conforms
to the essential requirements of the
Medical Devices Directive 93/42/EEC.
Manufactured by
ETL Mark and Control Number.
5000028
16
Idoman Teoranta
Killateeaun,
Tourmakeady, Co
Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
E-mail: [email protected]
Web Site: www.idoman-med.com
0120
Distributed by: Place Distributor’s Label Here
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TREATMENT STOP
Do Not Remove
ENTFERNEN SIE DEN BALLON AUS DEM UTERUS ERST NACHDEM DIE
MELDUNG „FINISHED V: XX ml Withdraw Balloon“ AUF DEM
LCD- BILDSCHIRM ERSCHEINT.
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Isolationswiderstand
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NOT-AUS
Temperaturbegrenzung
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0120
5000028
31
Idoman
Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
E-mail:
[email protected]
Web Site:
www.idoman-med.com
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OUVERTURE ET INSTALLATION DE LA CARTOUCHE JETABLE
STERILE THERMABLATE EAS
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DISCARD
USED CARTRIDGE
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Ouvrir ici
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Idoman Teoranta
Killateeaun,
Tourmakeady, Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
Courriel: [email protected]
Site Internet: www.idoman-med.com
0120
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Aprire Qui
ARRESTO DI EMERGENZA
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Idoman Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
E-mail: [email protected]
Sito Web:
www.idoman-med.com
0120
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PRECAUCION
LA PERFORACION DEL UTERO O LA CREACION DE
UNA LAS VIA, SI NO SE DETECTAN PUEDEN
GENERAR LESIONES TERMICAS DE LOS ORGANOS
O TEJIDOS AADYCENTES
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Testeo functional del dispositivo
ADVERTENCIA:
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Abra aquí
APAGADO DE EMERGENCIA
Límite de temperatura
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Límite de humedad
0120
Fabricado por
5000028
79
Idoman
Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
Correo electrónico:
[email protected]
Página Web: www.idomanmed.com
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Pegar etiqueta del
aqui
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por:
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of
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B)
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VERWIJDER DE BALLON ENKEL UIT DE BAARMOEDER, WANNEER
HET BERICHT “FINISHED V: XX ml Withdraw Balloon” VERSCHIJNT
OP HET LCD-SCHERM.
.
90
***WARNING***
*Metal End *HOT*
3. Draai de "POWER SWITCH” naar de "UIT"-positie.
91
92
93
de
droge
op
NOODSTOP
Temperatuurbegrenzing
Juiste rechtop positie
94
Aan positie van schakelaar
Stroomtoevoer is
ROHS-conform
0120
Vervaardigd door
5000028
95
Idoman
Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
E-mail:
[email protected]
Web Site: www.idomanmed.com
0120
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Pre-menopaus status
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finns
med
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AVBROTT / AVSLUT AV BEHANDLINGEN
OM AVBROTT/AVSLUT AV BEHANDLINGEN ÄR NÖDVÄNDIGT ELLER
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NÖDSTOPP
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Produkten måste hanteras enligt WEEE
Direktiv 2002/96/EC
0120
5000028
60601,1:08 Medicinsk elektrisk utrustning,
del 1
110
Idoman
Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
E-mail: [email protected]
Web Site:
www.idoman-med.com
0120
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Brugsanvisning
OPSÆTNING
1.
En (1) strømførende ledning (som passer til lokale
AC- stikkontakter)
En (1) TCU-holder.
5.
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3
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2.
3.
4.
Hvis
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NØDSTOP
Opbevares tørt
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Produktet skal bortskaffes i henhold til
WEEE-direktiv 2002/96/EC
0120
125
Idoman
Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Ireland
Tel No: +353 94 95 44726
Fax No: +353 94 95 44725
E-mail:
[email protected]
Hjemmeside:
www.idoman-med.com
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FI
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POTILASVALINTA
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5000028
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Idoman Teoranta
Killateeaun,
Tourmakeady,
Co Mayo
Irlanti
Puhelin: +353 94 95 44726
Faksi: +353 94 95 44725
Sähköposti: [email protected]
Verkkosivusto:
www.idoman-med.com
0120
143
NOTES
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For further information please contact
Customer Service
IDOMAN TEORANTA
KILLATEEAUN
TOURMAKEADY
COUNTY MAYO IRELAND
TELEPHONE +353 (0)94 9544726
FAX +353 (0)94 9544725
WWW.IDOMAN-MED.COM
For additional enquiries contact:
[email protected]
Customer Service Canada
Tel: + 416 487 8397
Toll Free:1800 768 1836
Toll Free Fax: 1888 763 1356
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