THE CAVATERM PLUS CENTRAL UNIT Operators Manual June 2014

ml

Do not use catheter if package is damaged

Catheter A

Electrical connector

H

Syringe switch

B

Mechanical connector

I

Catheter handle

C

Connector handle

D

Drain tube

E

Luer valve

J

Balloon adjustment with cavity length scale

F

Luer cap

K

Cervical canal scale

G

Pressure regulating-syringe

L

Silicone balloon

Technical specifications of Catheter Device length

1.3 – 1.4 m

Cavity length scale

4 – 8 cm

Diameter at cervix

6 – 7 mm (cone shape)

Max. recommended volume

30 ml

Target temperature

78°C

Operating mean temperature range

70 – 80°C

Recommended operating pressure

230 – 240 mmHg

Max. power

95 W

Shutdown pressure

300 mmHg

Treatment time

10 minutes

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The Cavaterm™ plus catheter is compatible with the equipment listed below : CAV 1020-10 Cavaterm™ first generation central unit CAV 2020-10 Cavaterm™ plus second generation central unit CAV 2020-20 Cavaterm™ 3 third generation central unit

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Indication The Cavaterm™ system is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Contraindications • Undiagnosed uterine bleeding. • Any premalignant or malignant condition by histology e.g. adenomatous hyperplasia. • Any anatomical or pathological condition significantly deforming the uterine cavity and thus preventing the balloon from laying uniformly on the endometrium e.g. septum, fibroids. Note Fibroids under 2 cm are not considered to significantly deform the uterine cavity and thus are not a contraindication. • Any condition associated with a myometrio thickness less than 12 mm (at the fundus and wall thickness must be uniform) e.g. cesarean section scars, GnRH pretreatment, prior gynecological surgery. • Any condition leading to uterine wall weakness irrespective of myometrio thickness e.g. vascular malformation of the wall, or history of classical cesarean section. • Any recent uterine damage or trauma. • Pregnancy or any desire to become pregnant in the future. • Uterine cavity length less than 4 cm or more than 10 cm (from the isthmus to the fundus). • Cervical canal length more than 6 cm. • Active infection of the internal and external genitalia. • Active urinary tract infection.

Warnings In order to ensure safe use of the Cavaterm™ plus device, it is imperative that this section is carefully reviewed (see also Warnings and Precautions in the central unit operator’s manual). • Before using the Cavaterm™ plus catheter, make sure that all components are contained in the sealed package (Fig. 1). If a component is missing, please do not use the catheter. Return it to Veldana Medical SA via your supplier. • The Cavaterm™ plus catheter is to be used only by qualified physicians who have received appropriate training regarding the use of the system.

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• The Cavaterm™ plus catheter is for single-use and must not be reused. • The Cavaterm™ plus catheter must not be resterilised. Resterilisation may lead to failure of the catheter. • The balloon adjustment device should be adjusted accordingly to the measured cavity length. A balloon length adjusted longer than the uterine cavity would risk burning the cervical canal and the cervix. If the measured cavity length is between the units of the marked cavity length scale, the shorter unit should be used. For example, if the measured cavity length is 4.7 or 4.8 cm, the length should be adjusted to 4.5 cm. • The balloon adjustment device should be secured tightly. Failing to secure it tightly may lead to an inappropriate balloon length and heating of the cervical canal. • Never exceed a pressure of 240 mmHg. Overpressure may lead to uterine rupture. • If a pressure of 230-240 mmHg cannot be reached after filling with 30 ml of glucose, then interrupt the filling procedure. Empty the balloon and remove the catheter from the patient. Fill balloon with 10 ml of glucose 5% (50 mg/ml) and inspect for leaks. If a leak is found replace the catheter with a new one and restart the procedure. If no leaks are found, do not reinsert the balloon catheter. The possible cause of this has to be determined including the possibility of uterine rupture or perforation and it should be reconsidered treating the patient with the Cavaterm™ system. • If multiple or continuous fluid infusions are required to maintain the target pressure of 230-240 mmHg, consider possibility of uterine rupture or perforation. Uterine relaxation can cause a slow decrease of pressure and the pressure would easily be readjusted with a single minor fluid infusion with syringe’s plunger rotation. • Never fill the balloon with more than 30 ml of glucose solution 5%. Exceeding volume may lead to uterine rupture. • Do not block the drain tube of the Cavaterm™ plus catheter. In case of high pressure the central unit will open a valve that will allow excess liquid to drain through the tube. • Do not attempt to fill the balloon without having the connector fully inserted into the central unit. Doing so can damage the catheter. • Do not use excessive force when introducing the catheter into the uterus. If a resistance is felt, dilate to Hegar 7. Then attempt to reintroduce the catheter. If resistance to catheter placement persists, abort the procedure. • Ensure that the catheter remains in position (Fig. 9) during the duration of the treatment. Misplacement of the catheter during the treatment may lead to cervical canal burn. • Do not start the procedure if there is any question concerning balloon position. If question exists, verify the balloon position by the following steps :

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1 The catheter shaft in vagina can be inspected by speculum exam ; the catheter shaft is marked every 1 cm indicating the distance from the balloon (Fig. 1, K). Prior to the procedure, the cervical canal length should have been measured with Hegar dilator, and the measured length should correspond to the inspected marked length on the shaft. 2 If balloon position is still in doubt after catheter shaft inspection or sufficient inspection is not possible, abdominal ultrasound can be performed to confirm the intrauterine position of the balloon. 3 If there is still doubt concerning the balloon position after catheter shaft inspection and abdominal ultrasound, or sufficient abdominal ultrasound examination is not possible, the ablation procedure should be abort. Note In case of suspected uterine perforation or rupture, laparoscopic or hysteroscopic assessment should be performed depending the level of risk. • The catheter tubing contains electrical wires. Do not cut the catheter tubing unless the catheter is detached from the central unit. • If the catheter does not function as expected, please cleanse it with water, put it in a hermetic bag and send it back to Veldana Medical SA via your supplier in order to allow the manufacturer to perform investigations.

Precautions • In all cases vaginal ultrasound screening is necessary in order to ensure minimal myometrio thickness of 12 mm throughout the uterus. • In case of pretreatment with GnRH agonist or medroxyprogesterone acetate (MPA), a vaginal ultrasound has to be performed within 10 days prior to the Cavaterm™ procedure to evaluate the minimal myometrio thickness of 12 mm throughout the uterus. • In case of history of previous endometrial ablation, a vaginal ultrasound has to be performed to evaluate the minimal myometrio thickness of 12 mm throughout the uterus. • Always fill the balloon with glucose solution 5%. Other fluids may cause failure of the system. • If the catheter cannot be removed when pressing the YELLOW stop key, insure the system pressure is below 30 mmHg by emptying the balloon. Note that the catheter cannot be removed if the system (heat and pump) is activated. • Do not attempt to remove the catheter from the central unit as long as you can hear a humming sound. The humming sound means that the system is activated and there are mechanical operations occurring. Removing at this time can damage the system.

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Adverse Effects The following adverse effects have been reported and/or possible : • Pelvic pain – is usually present the first day post-treatment and can be managed with pre-procedure and post-procedure administration of non-steroidal anti-inflammatory drugs. • Endometritis – oral antibiotic treatment is usually sufficient to control the infection. • Vaginal discharge, which can last several days or weeks post-treatment. • Uterine perforation – can be associated with insertion of any intrauterine instrument. • Uterine rupture – uterine rupture may occur, necessitating hysterectomy or laparoscopic repair. • Cervical canal burn/hematometra – if the balloon is not fully introduced into the uterine cavity, and/or the balloon length has not been properly adjusted to the measured uterine cavity length, and/or the adjustment device has not been firmly secured, heating of the cervical canal may occur leading to a burn.

Preparations 1 For the preparation of the central unit, see the central unit operator’s manual. 2 Provide 50 ml of sterile glucose solution 5%.

Procedure 1 Perform a bimanual examination to determine whether the uterus is anteverted or retroflexed. Carefully sound the uterus, taking care not to perforate, and note the length of the cervical canal, the total length from fundus to cervical os, and the length of the endometrial cavity (see Fig. 2 to 4). 2 Press the BLUE power-on/off key on the central unit to activate the system. 3 Unpack the sterile balloon catheter. If any component is missing, do not use the set. 4 Press the GREEN Start key. 5 Hold the catheter by the connector and insert it into the central unit (flat connector surface on the top). The pump compartment will close (a humming sound can be heard from the motor inside the central unit). All necessary connections are automatically made. Note If the pump compartment does not close (no humming sound) : a Make sure that the connector is fully inserted.

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b If you are using a Cavaterm™ first or second generation central unit, this might occur if the catheter indicator is not flashing. Press the GREEN start key once. 6 Unlock the balloon adjustment device by gently turning it (Fig. 5). Adjust the balloon length to the measured uterine cavity length by gently sliding it (Fig. 6). Fix the balloon adjustment by turning it back in the locked position (Fig. 7). A click sound should be heard. Note In the case of an uterine cavity size in the range of 8 cm to 10 cm, set the adjustment device to 8 cm. is visible. 7 Push the syringe switch until the symbol This frees the plunger and the released position is selected. If you are using a Cavaterm™ 3 central unit, please ignore sections 8 to 10 and continue from section 83. 8 Fill the supplied syringe with 30 ml of glucose 5%. Remove the cap from the luer lock valve and attach the syringe to the valve by twisting it all the way. 9 Hold the catheter vertically with the balloon pointing upwards and fill the balloon with 30 ml of glucose 5%. 10 Turn the catheter upside down with balloon pointing downwards and pull the syringe plunger to extract all liquid and air from the balloon. Remove air from syringe and refill with glucose 5 %. Repeat steps 7 and 8 until all air is removed from the balloon. Only for users of the Cavaterm™ 3 central unit. If you are using a Cavaterm™ (first generation) or Cavaterm plus (2nd generation) central unit, please ignore sections 83 to 103 and continue from section 11. 83 Fill the supplied syringe with 17-20 ml of glucose 5 %. Remove the cap from the luer lock valve and attach the syringe to the valve by twisting it all the way. 93 Remove all air from the catheter by injecting all 17-20 ml of glucose 5 % into the catheter pointing downwards. You will notice drops of fluid escaping from the drain tube. 103 Retrieve the syringe plunger in order to empty the balloon completely and press the GREEN Start key. 11 Refill the syringe with 30 ml of glucose 5 %. The catheter is now ready for use. 12 Insert the catheter until the fundus is reached (Fig. 8). If a resistance is felt, while passing the cervical canal, dilate to Hegar 7 and then insert the catheter. Check the correct position of the catheter by ensuring the proper cervical canal length is shown on the cervical canal scale. 13 Hold the catheter in position while inflating the balloon. Gently inject glucose 5 % until an initial pressure of around 200 mmHg is displayed on the central unit. At this point slide is visible. This secures the syringe switch until the symbol the plunger and the rotating position is selected. Continue to inject glucose 5% by turning the plunger in a clockwise

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direction until a stable pressure of 230-240 mmHg is obtained (Fig. 9). Ensure that the catheter remains in position during the duration of the treatment. Misplacement of the catheter during the treatment may lead to cervical canal burn. Caution In case of unaddressed loss of pressure, abort the procedure and do not reinsert the catheter. Determine the cause of loss of pressure before considering further treatment ; please see Warnings section. 14 Press the GREEN start key on the central unit once. The circulation and the heating of the liquid in the balloon will start (Fig. 10). The temperature will stabilise within the operating mean temperature range of 70-80°C. Caution Constantly maintain a balloon pressure of 230-240 mmHg by gently turning the plunger clockwise (to increase the pressure) or counter clockwise (to decrease the pressure). A maximum volume of 30 ml must not be exceeded. 15 The heating and circulation continue until the treatment time has elapsed.

End of procedure 1 At the end of the treatment, the circulation and heating of the liquid in the balloon stop automatically and a buzzer signal sounds. 2 Press the YELLOW stop key on the central unit if you are using a first or second generation unit. If you are using a third generation central unit, take step 3. 3 Release the syringe plunger by pushing the syringe switch is visible. Empty the balloon by until the symbol pulling on the syringe plunger. Maintain negative pressure until all fluid has been retracted. Remove the catheter from the uterus. 4 Press the YELLOW stop keys on the central unit ; wait until the pump compartment has opened completely ; a humming sound should be heard; when the humming sound has stopped, remove the catheter from the central unit. Caution If the pump compartment does not open and the catheter is not released, then make sure that the system pressure is below 30 mmHg. 5 Press BLUE power on/off key on the central unit to switch off the system. 6 The catheter connector contains a memory chip which records treatment data. Should you desire to have the memory chip analysed by Veldana Medical SA, then return the catheter connector to your supplier. Put the catheter connector in a proper sealed package ; do not enclose any patient personal data in the package.

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