THE CAVATERM CENTRAL UNIT Operators Manual

Page 1

THE CAVATERMTM CENTRAL UNIT

OPERATOR‟S MANUAL

F-96J07-M

Manufacturer

Pnn Medical SA

PO Box 2036, Riond-Bosson 14, CH-1110 Morges 2, Switzerland

Phone +41 21 8049900, Fax +41 21 8049901

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1

1.1

TM

CAVATERM

The Cavaterm

Central Unit – Operator‟s Manual

SYSTEM FOR THE TREATMENT OF MENORRHAGIA

system

The treatment is based on heat in combination with pressure. Histology shows that a uniform tissue

destruction of 6 - 8 mm in depth is obtained using the Cavaterm system. The bleeding diminishes or

ceases completely. The Cavaterm system consists of two parts, a single-use balloon catheter and a

stationary battery operated central unit.

Cavaterm

system (catheter and central unit)

The Cavaterm plus catheter uses a circulation system and a self-regulating heater. After insertion of the

catheter into the uterus, the balloon is inflated with a non-conducting fluid until a pressure of 230 - 240

mmHg is obtained. The balloon pressure will reduce the blood flow in the adjacent tissue and thus reduce

the cooling effect. The heat is produced by the unique heating elements with inherent

self-regulating properties. The heating elements are powered by the battery operated Cavaterm central

unit. The fluid is brought into vigorous circulation inside the balloon by the pulse generator in the central

unit. This vigorous circulation ensures uniform heat distribution on the balloon surface and thus a uniform

and optimal destruction of the uterus endometrium.

1.2

How to use this manual

This manual describes the operational functions of the Cavaterm central unit. For the operational

functions of the Cavaterm™ plus catheter, see the document 'Instructions for Use' delivered with the

catheter. You must read both documents completely before operating the system. Start by carefully

reading the sections 'Warnings' and 'Precautions'. Then proceed by reading the remainder of the manual

and the Cavaterm™ plus 'Instructions for Use' delivered with the catheter before performing any work with

the Cavaterm system. When you have received proper training and have gained a working knowledge of

the system, then use this manual as a reference guide.

1.3

Warnings

Please help us ensure continued safe use of the equipment, by carefully reviewing the information in this

section (see also sections 'Warnings' and 'Precautions' of the document 'Instructions for Use' of the

Cavaterm™ plus catheter).

Do not attempt to open the Cavaterm central unit, charger or battery packs; doing so might lead to

potential hazards. There are no user serviceable parts inside the central unit or battery packs.

Do never block the drain tube of the catheter; the drain tube is part of the overpressure safety

system, blocking it might result in an overpressure and uterine rupture.

Never exceed pressure of 240 mmHg. Overpressure may lead to uterine rupture.

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1.4

Central Unit – Operator‟s Manual

Precautions

The Cavaterm system is to be used only by qualified physicians who have received appropriate

training regarding the use of the system.

Always use the supplied charger when recharging the batteries. Using a different charger may

shorten the battery life and may lead to potential hazards.

If the Cavaterm™ central unit was transported and/or stocked below a temperature of 10°C, please

allow the device to warm up to room temperature before using it.

Store unused batteries at normal room temperature. Overheating might damage the batteries and

can lead to potential hazards.

The Cavaterm central unit including charger and battery packs is an electrical device. An electrical

short-circuit created by inappropriate manipulation may lead to potential hazards.

The device complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting

equipment, cellular phones, etc. shall not be used in close proximity of the device since this could

influence the performance of the device. Strong emission sources such as High Frequency surgical

equipment and High Frequency cables should not be routed on or near the device. If in doubt,

contact qualified technician or the manufacturer.

When a catheter, with the luer cap on, is inserted the maximum value displayed should be

10 mmHg; if a higher value is displayed, send the central unit for service.

The central unit and the batteries must be returned to the distributor or the manufacturer for recycling

after usage. The central unit and the batteries must be recycled or disposed of properly. Do not

dispose of in fire!

1.5

Responsibility of the manufacturer

Pnn Medical SA is responsible for the safe operation, reliability and performance only if:

Readjustments, modifications and training are performed by staff authorised by Pnn Medical.

The Cavaterm system is used in accordance with the instructions for use by physicians who have

received appropriate training.

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1.6

Central Unit – Operator‟s Manual

Equipment symbols

1.6.1 Central unit

Two information labels are placed on the Cavaterm central unit. The large information label is placed at

the rear of the central unit and the smaller identification label is placed on the bottom plate underneath the

unit.

Cavaterm

TM

Model: 3000 Gyn V2.0

SN

See bottom

Battery voltage: 24 V.

XXXX

YYYY

Patents and pending patents

F-99B

02-B

Bottom plate

Pnn Medical SA Morges Switzerland

F-99B01-D

Rear of unit

On these labels different symbols are found. The symbols have the following meaning and purpose.

The symbol, SERIAL NUMBER, is used to identify

the serial number. XXXX in the figure above

denotes the identification serial number for this

specific central unit.

Identification label and SERIAL NUMBER

The symbol, SIGNATURE OF QUALITY CONTROL

OFFICER, is used to identify the person performing

the Quality Control function. YYYY is an

identification code identifying the person who

performed the final test on this central unit. The

signature is a confirmation that the unit has received

an internal approval.

Identification label and SIGNATURE OF QUALITY

CONTROL OFFICER.

The symbol, DATE OF MANUFACTURE, is printed

for informative reasons and accompanied with year,

month and day (format YYYY-MM-DD) the

Cavaterm™ central unit passed the final inspection.

Identification label and DATE OF MANUFACTURE

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Central Unit – Operator‟s Manual

On the information label the following symbols are found.

ATTENTION, SEE INSTRUCTIONS FOR USE

The symbol, ATTENTION, SEE INSTRUCTIONS

FOR USE, indicates that a printed user's instruction

(OPERATORS MANUAL) is supplied together with

the Cavaterm central unit. The OPERATORS

MANUAL contains important information, read the

instructions carefully before using the system.

The symbol, CE MARK, indicates that the unit has

been approved and certified by the notified body,

which number is 0120.

CE-MARK

This symbol indicates that the unit has been

approved as a class I type BF equipment.

TYPE BF EQUIPMENT

This is the symbol for recycling. After usage, return

the unit to distributor or to manufacturer for

recycling.

This equipment contains lead acid batteries and

must be disposed of properly or recycled. Do not

dispose of into fire.

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2

2.1

Central Unit – Operator‟s Manual

Getting started

Unpacking

The unit is shipped in a cardboard box with 2 battery packs, charger and manual. Please save all packing

material in case the unit has to be returned to the distributor or manufacturer for service or upgrade.

Open the box

From above

Central unit with floating support.

The Cavaterm™ central unit is placed in a flight case with floating support to protect it during the shipment.

Short side

Front Long side

Lift the unit out of the box

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Central Unit – Operator‟s Manual

Short side

Charger

Front Long side

Battery Pack

Charger

Battery Pack

Location of charger and battery packs:

The batteries and charger are individually packed and located in the bottom of the main cardboard box.

Please remember to store the packing material for future use.

2.2

Transport safety switch

Before operating the unit make sure that the transport safety switch is placed in the ON position. To set the

switch, use a pen or similar object and slide the switch to the ON position. After doing this install the main

battery.

The switch should always be in the OFF position during shipment and storage to protect the electronics and

the internal back-up battery.

Transport safety switch

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2.3

The Cavaterm™ Central Unit

The Cavaterm™ central unit is a battery operated power supply and monitoring device intended to be used

together with the Cavaterm plus catheter. A pump unit is also integrated into the Cavaterm™ central unit.

This device will promote a vigorous circulation of the fluid located inside the balloon.

The central unit

The rechargeable battery pack is installed at the rear of the unit (1).

The Cavaterm™ plus catheter is connected to the power supply when introduced into the pump slot (2).

The Cavaterm™ system is operated using the keyboard and display unit (3).

MAX.

MIN.

MEDICAL

WALLSTEN MEDICAL

SA MORGES

SWITZERLAND

The central unit front panel

2.3.1 Front panel

The system is operated from the keyboard located on the central unit front panel.

The front panel is divided into five blocks with related indicators and keys.

1 Main power

4. Temperature and heating power indicator

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2. Treatment status

5. Treatment time

3. Pressure monitor

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Central Unit – Operator‟s Manual

2.3.2 Keys

Below are the different keys and indicators described with their corresponding names and functions.

The blue ON/OFF button is used to

activate/deactivate the central unit. Keep the key

pressed for a few seconds to activate the unit.

The green START button is used to activate pump

and heat.

The yellow STOP button is used to deactivate the

acoustic signal noting the end of the treatment and

to release the catheter.

MODE: Used to select parameters on the

corresponding display.

LOW BATTERY: Indicates that the battery has to

be recharged.

HEAT ON: Indicates that the heating is active.

PUMP ON: Indicates that the pump is running.

CATHETER: A flashing light indicates that the

central unit is ready to accept a catheter. Constant

light indicates that the catheter is in place.

TIME TO GO ON: Indicates that the display is

showing the remaining treatment time.

TIME DONE ON: Indicates that the display is

showing completed treatment time.

TIME TO GO OFF and TIME DONE OFF: Total treatment time available for treatment with present catheter.

TIME TO GO ON and TIME DONE ON: Indicates several parameters after pressing the key repetitiously in

the following order: real time clock (mins & secs), real time clock (hour & mins), date (month & day), year,

total treatments done since last service.

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Central Unit – Operator‟s Manual

POWER ON: Indicates that the display is showing

current heating power.

TEMP ON: Indicates that the display is showing the

actual temperature of the fluid inside the balloon.

TEMP AVG. ON: Indicates that the display is

showing the average temperature calculated since

the start of the ongoing or just finished treatment.

MAXIMUM PRESSURE ON: Indicates that the

display is showing the upper system pressure limit.

PRESSURE ON: Indicates that the display is

showing the actual system pressure

MINIMUM PRESSURE ON: Indicates that the

display is showing the lower system pressure limit

2.3.3 Indicator displays and operator keys

2.3.3.1

Main power

The blue ON/OFF switch and LOW BATTERY indicator.

ON/OFF key and LOW BATTERY indicator

Pressing the blue ON/OFF key will activate or deactivate the Cavaterm™ central unit. The LOW BATTERY

indicator will illuminate and an acoustic signal will sound when the system has detected a weak battery.

Replace the battery as soon as possible and never start a new treatment session with this indicator on.

In case the main battery goes below a certain level, an internal back-up battery will protect the unit from

losing stored treatment information. The pump as well as the heating will be switched off to protect the unit.

The same will happen if the main battery is removed during an ongoing treatment.

The internal back-up battery makes it possible to replace the main battery while the Cavaterm™ central unit

is active. The pump and heat will automatically be deactivated as described above and the indicators will

start flashing if pump and heat was active before the removal of the main battery. The system will

automatically restart when a charged main battery is reinstalled.

2.3.3.2

Treatment monitor

START/STOP keys and treatment indicators

After turning the power on, the bottom indicator 'Catheter' starts flashing. This indicates that the unit is ready

to accept a catheter.

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Central Unit – Operator‟s Manual

When introducing a catheter into the pump slot the pump compartment will automatically close. The

Cavaterm™ plus catheter connects to the central Unit. This includes the pressure readout means,

the over-pressure device, the pump and the low voltage power. The bottom indicator 'Catheter'

lights to indicate that the Cavaterm™ system is ready for use.

Pressing the green START button activates the pump and the heating. All three indicators are on which

indicates an ongoing treatment.

During the heat up phase, HEAT is displayed on the heat indicator until 60°C is reached. When

reaching the treatment temperature of 65°C, the treatment timer will start running. The heating will

terminate automatically after completing a treatment. The indicators HEAT ON and PUMP ON will

turn off.

Pressing the yellow STOP button will stop the acoustic signal.

Pressing the yellow STOP button a second time will allow the Cavaterm™ plus catheter to be removed. A

humming sound can be noted after pressing the yellow STOP button. When the motor has stopped,

removal of the catheter for disposal is possible.

Note: It is only possible to remove the Cavaterm™ plus catheter from the pump if the balloon is

empty and system pressure is below 30 mmHg.

After removal of the catheter, the central unit will automatically sense that no catheter is present in

the pump slot and reverts to waiting for another catheter. The bottom indicator 'Catheter' starts

flashing.

During an ongoing treatment procedure it is possible to pause the heating and the pump: Press the yellow

key to pause the treatment. This will stop the circulation and the heat. Press the green button once to restart

circulation and heat. This will resume the treatment.

2.3.3.3

Pressure monitor

Pressure monitor

By pressing the MODE key the readout mode is selected. The selected mode is indicated by the three

indicators below the digital display. Three modes are possible (from the top):

Maximum system pressure limit

Actual system pressure (default)

Minimum system pressure limit

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2.3.3.4

Central Unit – Operator‟s Manual

Heating status indicator

The power and temperature display with selector.

Heating status indicator

By pressing the MODE key the readout mode is selected. The three indicators below the digital display

indicate the selected mode. Three modes are possible (from the top):

Actual heating power

Actual balloon temperature (default)

Average balloon temperature

After completing a treatment cycle a calculated average value will be displayed, this value has been

calculated as an average for the duration of the treatment.

2.3.3.5

Treatment timer

Time display and MODE selector.

Treatment timer

During a treatment:

By pressing the MODE key during a treatment, the readout mode is selected. The two indicators below the

digital display indicate the selected mode. Three modes are possible during the treatment:

Remaining time (upper indicator lit)

Completed time (lower indicator lit)

Total time available for treatment from the beginning (both indicators lit)

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Central Unit – Operator‟s Manual

In standby mode:

To verify the function of the clock and the treatment counter: press the time key when the central unit is 'on'

and no catheter is inserted (for example before performing a treatment). Press the time key repetitiously (8

times) to view the following information in this order:

1) Treatment time available with the inserted catheter (when no catheter is inserted, this value

equals 10.00; upper LED 'on').

2) Performed treatment time with the inserted catheter (when no catheter is inserted, this value is

00.00).

3) Total treatment time.

4) Minutes and Seconds (format MM.SS) of clock.

5) Minutes and Hours of clock (format HH.MM).

6) Date (MM.DD).

7) Year (YYYY).

8) Number of treatments performed since last service of central unit.

2.3.4 Rear panel

The main battery pack is located at the rear panel. To remove the battery:

Lift the locking device

Rotate the battery unit out from the unit (see figure A and B below).

If the battery is replaced during an ongoing treatment, the heating and pump will automatically be

deactivated. If activated at the time of removal of the battery then the corresponding indicators PUMP ON

and HEAT ON will start flashing. The parameters will remain on display for a maximum of 15 minutes using

the internal battery. After replacement of the main battery the unit will automatically reactivate heat and

pump if activated before the removal.

Replacing the battery pack

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3

3.1

Central Unit – Operator‟s Manual

OPERATION

Charging the batteries

Note: The charger is designed for domestic and office use. The charger should not be used in the

operating room or in any facility where a device having certifications according to IEC 335-1 and IEC

336-2-29 is not allowed.

The sealed batteries are of lead/acid type and filled with a gel. The batteries can be charged at any time and do not

require discharging. Using the charger shipped with the unit, there is no risk of overcharging or damaging the

batteries. The batteries can be left connected to a plugged charger when not in use. Always disconnect the charger

from the battery pack when not connected to the mains. The charger and battery packs are electrical devices. An

electrical short-circuit created by inappropriate manipulation may lead to potential hazards due to electrical energy.

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battery charger

 Connect the charger to a suitable

mains outlet.

 Using the battery connection plug,

connect the charger to the battery pack.



a

b

c

Charger Type I (Model G124-1)

 The indicator on the

charger will light. The

charge indicator LED is

constantly lit when the

battery needs to be

recharged.

Charger Type 2 (Model 600-62320)

 The indicators on the

charger will light noting

that the mains are “ON”

and that charging has

begun.

When the battery has

reached a fully charged

state the charge complete

will light.

The indicator intensity

will diminish during the

charge cycle.





 When the battery has

reached a fully charged

state the LED indicator

will be very dim or

completely

extinguished.

A full recharge cycle will

take approximately 4 - 5

hours.

Recharging after one

treatment session will

normally take

approximately one hour.



A full recharge cycle will

take approximately 4 - 5

hours.

Recharging after one

treatment session will

normally take

approximately one hour.



To check whether a

battery is fully charged,

connect the charger‟s

battery plug and the

green indicator will

temporarily light up.

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3.2

Set up of Cavaterm

Central Unit – Operator‟s Manual

central unit

The only preparation needed prior to a treatment is to assure that the batteries are fully charged. Although

the batteries will last up to three treatment sessions, always start a treatment with a fully charged battery.

To set the Cavaterm™ central unit into standby press the blue ON/OFF key firmly. An internal test

procedure will start and the unit will display a welcome message if no errors are detected.

Power on message

Display after start-up.

3.3

Factory set parameters

The following parameters are factory set:

o Treatment time (see document 'Instructions for Use' supplied with the catheter).

o Maximum system pressure, factory setting 270 mmHg.

At the maximum system pressure, the warning buzzer will sound. If the Cavaterm™ system pressure

remains at this level for a time period longer than 30 seconds then the heating and pump will stop

automatically.

o

Absolute maximum pressure, factory setting 300 mmHg (pump off) and 320 mmHg (pump

on).

If a pressure above 320 mmHg is measured, then the unit will immediately open an over pressure device

letting the fluid out and interrupt the treatment. To restart the treatment, adjust pressure to 230 – 240 mmHg

and press the green button.

Note: The maximum pressure setting works independently of the mechanical over-pressure valve that is

factory set.

o

Minimum pressure limit, factory setting 100 mmHg

If the pressure drops below this limit the alarm will sound. If the Cavaterm™ System pressure remains

below this level for a time period of longer than 30 seconds, the system will pause the treatment.

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4.1

Central Unit – Operator‟s Manual

FUNCTIONS OF THE CENTRAL UNIT DURING THE PROCEDURE

Preparation

Turn safety switch to 'ON' position

Ensure that the batteries are fully charged. Insert one battery pack in the compartment at the rear of

the central unit.

The following steps 'Patient and catheter preparations' are described in the document 'Instructions

for Use' available with the Cavaterm™ plus catheter.

4.2

Treatment

During the treatment, the central unit monitors the treatment parameters and displays it to the user. The

user controls the balloon pressure based on the information provided by the central unit. All other treatment

parameters like treatment duration and temperature are monitored automatically. The treatment procedure

is very easy to learn and can be carried out by pressing 3 keys.

On insertion of the catheter into the slot of the Cavaterm™ central unit, the pump compartment will

close. All necessary connections are automatically made.

Note:

If the pump compartment does not close (a humming sound should be heard from the motor

inside the Cavaterm™ central unit), make sure that the catheter connector is fully inserted

into the pump slot. If the pump compartment does not close then press the green start

button once. This might occur if the indicator is not flashing (i.e. a catheter was removed just

before insertion in the uterus).

The green START button on the Cavaterm™ central unit starts the pump and heating.

Start

Note:

If the treatment has to be interrupted for any reasons, press the yellow STOP button once.

Pressing the green START key can then restart the treatment. The three indicators between

the two keys indicate the treatment status.

The time countdown starts when the temperature reaches 65°C or after a heating time of 5

minutes.

Heating will continue until the treatment time has elapsed. At the end of the treatment a buzzer

signal shall be heard. Press yellow STOP button on the Cavaterm™ central unit to stop the buzzer

signal.

Stop

Press the yellow STOP button again and remove the Cavaterm™ plus catheter from the central

unit.

Note:

If the pump compartment does not open and the catheter is not released, then make sure

that the system pressure is below 30 mmHg.

4.3

End of the treatment

Remove and recharge the battery pack.

Turn off the safety switch at the rear of the central unit.

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5.1

Central Unit – Operator‟s Manual

CENTRAL UNIT TROUBLE-SHOOTING

Error and Warning Messages (summary of troubleshooting under central unit)

Warning/Error Messages

Description

Action

SEND FOR SER

Send in for service.

The central unit has

performed the number of

treatments requiring a

service or the central unit

has not been serviced for 3

years.

CAT USED

Catheter used.

This catheter has already

been used for a treatment.

As the Cavaterm™ plus

catheter is a disposable

(single-use) device, it cannot

be re-used.

CAT EP

Catheter expired.

This message means

„Catheter expired‟. The

Cavaterm™ plus catheter

expires three years after

production.

Treatments can still be carried out,

but the central unit needs to be sent

in for servicing as quickly as

possible.

To use the central unit for a

treatment, press the yellow key

once. The central unit is ready for

insertion of the catheter. The

treatment can be carried out as

usual.

Press the yellow key once to stop

the acoustic alarm. The writing „Cat

out‟ appears. Press the yellow key

once more to take out the catheter.

Dispose.

If you know that the catheter has not

been used: please send catheter

back to Pnn Medical SA with a

device complaint form and

explanation.

Press the yellow key once to stop

the acoustic alarm. Press the yellow

key once more to take out the

catheter and dispose.

„HI‟ with OP-device open for

pressures over 300 mmHg

(Circulation/heat not activated)

High pressure.

High pressure may cause

uterine rupture. This alarm

consists of an acoustic

signal and the „Hi‟ message

blinking on the pressure

display.

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The central unit opens automatically

the OP-device. Fluid comes out of

the OP-tube for one second. The

OP-valve closes with a balloon

pressure below 300 mmHg. The „Hi‟

Message disappears. Readjust

pressure to 230 – 240 mmHg and

continue procedure.

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Warning/Error Messages

Description

Action

CAT DEFECT

Catheter defective.

The central unit has

detected a problem with

either an improperly

purged catheter or the

heating elements.

„HI‟ message for pressures over

270 mmHg.

(Circulation/heat activated)

High pressure.

High pressure may cause

uterine rupture. This alarm

consists of an acoustic

signal and the „Hi‟

message blinking on the

pressure display.

A) If this occurs before the

countdown starts: Press the yellow

key once to stop the acoustic alarm.

„Cat out‟ appears. Pull out liquid from

balloon. Press the yellow key once

more to take out the catheter. Do not

use the catheter. Send it back to Pnn

Medical SA with a device complaint

form and explanation.

B) If this occurs during the

treatment: Press the yellow key once

to stop the acoustic alarm. „Cat out‟

appears. Pull out liquid from balloon

and extract catheter from uterus.

Press the yellow key once more to

take out the catheter. Reinsert and

repurge it. Resume treatment. If

message reappears, send it back to

Pnn Medical SA with a device

complaint form and explanation.

Gently pull out fluid from the balloon to

decrease pressure to 230-240 mmHg.

„LO‟ message for pressures

below 100 mmHg.

(Circulation/heat activated)

Low pressure.

Low pressures can be

responsible for an

inefficient treatment. This

alarm consists of an

acoustic signal and the „Lo‟

message blinking on the

pressure display.

Gently inject fluid to increase pressure

to 230 - 240 mmHg.

Note: Low pressure might be caused

by a catheter leak, a misplaced

catheter or an uterine rupture. See the

section “Warning” of the document

'Instructions for Use' of the

Cavaterm™ plus catheter.

„STOP‟ Message with OP-device

open for pressures over 320

mmHg.

(Circulation/heat activated)

Pressure above max.

limit.

High pressures above 320

mmHg may cause uterine

rupture. This alarm stops

circulation/heat

immediately when 320

mmHg pressure is

reached, opens the OPdevice to evacuate fluid

from the balloon and sends

out an acoustic alarm.

Wait for pressure to drop below 320

mmHg (automatically done by the

open OP-device evacuating fluid from

the balloon). Verify pressure and if

necessary readjust. Press the green

key to resume the treatment.

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Central Unit – Operator‟s Manual

Warning/Error Messages

Description

Action

CAT BAL STOP

Sudden pressure drop.

This alarm is triggered

when pressure in the

balloon has dropped very

fast and remains at a low

level. This can be a sign of

a ruptured balloon, a

uterus rupture or a

mechanical problem.

A) If this occurs before the

countdown starts:

Clear the acoustic alarm by pressing

the yellow key. Ensure that the balloon

adjustment is still properly set. If not,

deflate balloon and readjust. Press the

green button and slowly inject liquid to

readjust the pressure to 230 - 240

mmHg. If after 30 ml you are unable to

achieve this pressure follow

indications below.

B) If this occurs during the

treatment:

Clear the acoustic alarm by pressing

the yellow key. Verify integrity of

balloon and uterus.

Pull out liquid from balloon and extract

catheter from uterus. Verify integrity of

balloon. Check if pressure sensor

works by injecting some liquid into the

balloon and pressing it gently with your

hand. Verify that the pressure display

reacts with circulation both off an on. If

all OK, check integrity of uterus with

hysteroscope. If all OK, resume

treatment.

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6

Central Unit – Operator‟s Manual

BATTERY CHARGER

The charger is designed for domestic and office use. The charger should not be used in the operating room

or in any facility where a device having certifications according to IEC 335-1 and IEC 336-2-29 is not

allowed. The charger does not need any scheduled service other than the annual check-up. If the charger

needs cleaning, make sure that no fluid enters the charger unit.

6.1

Safe use and adequate maintenance of rechargeable batteries

The battery pack does not need any scheduled service other than the annual check-up.

The fully charged battery pack can be stocked at 20°C up to 10 month without recharging (80% capacity).

Higher stockage temperatures will shorten this time, for example, at 40°C only 2 months.

The battery should be fully charged before use and deep discharge should be avoided (treatment with

discharged batteries). Deep discharge will shorten the life time of the battery pack. The life time of the

battery pack is 4 years (at 20°C, adequate use).

If the battery units need cleaning, use a dry soft cloth or in rare cases a mild detergent. When using a

detergent, never touch the terminals on the battery.

Note: Remember to disconnect charger from the mains when not in use or during cleaning. The charger

and battery packs are electrical devices. An electrical short-circuit created by inappropriate manipulation

may lead to potential hazards due to electrical energy.

6.2

Specifications of charger unit

The charger is designed to charge sealed lead acid batteries with a nominal voltage of 24V.

The charging of the batteries is fully automatic due to the voltage limited charging process. Overcharging is

impossible. The charger may remain continuously connected to the battery. If the charger is disconnected

from mains then always disconnect the unit from the battery, otherwise the battery will be discharged

through the charger.

The charger is equipped with a 2-step charging. When connected to a not fully charged battery, the charger

will automatically go into a recharge mode. This mode is active until the battery is fully charged. Then the

charger automatically reverts to a maintenance charging.

The charger is protected against short-circuit and reverse polarity, and is equipped with a thermal

overcharge protection.

6.3

Malfunctions and trouble shooting

Please contact authorised personnel for troubleshooting.

If the charging of the battery does not work, a possible reason could be defective fuses. Call for a trained

service engineer. The internal fuse has to be checked and possibly replaced. Do not attempt to open the

charger unit; there are no user serviceable items inside. All attempts to repair the unit have to be performed

by personnel who have received proper training.

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Central Unit – Operator‟s Manual

Cavaterm™ central unit: Technical specifications

Size (L * W * H)

420 * 320 * 95 mm

Weight

6000gr (without batteries)

Lead acid batteries

Power source

3.5 Ah/ 24 V

Operating time

Maximum 3 hours at normal treatment heating power.

Lead acid battery

Back up battery

2.0 Ah/12 V

1 Hour (with inactive heating and pump)

Operating time

Set to 15 minutes by software

4 - 5 hour's main batteries

Recharge time

3 hour's backup batteries (recharged when a procedure is started)

Working and storage

temperature range

10°C to 35°C

Working and storage

humidity range

20% to 70% relative humidity

Transportation

conditions

F-96J07-M

Transportation switch OFF

Temperature range : 10° C to 35° C

Humidity range : 20% to 70% relative humidity

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Central Unit – Operator‟s Manual

Maintenance, cleaning preventive inspection and disposal

This section contains preventive maintenance instructions for the Cavaterm™ system. These maintenance

guidelines should be followed to prevent unnecessary equipment/supply failure and/or possible health

hazards.

The hospital or the institution is responsible for the use of this equipment and to implement a satisfactory

maintenance schedule; if failing to do so, it may cause equipment failure and possible health hazards.

Before each treatment

Check the 'Expiry Date' on the Cavaterm plus catheter container and make sure that the sealed catheter

box is not opened to ensure maintained sterility.

Make sure that the batteries are properly charged.

Monthly maintenance

Perform the following maintenance at the minimum on a monthly basis. Before starting any maintenance,

turn the system off.

Cleaning the exterior

The exterior of the Cavaterm central unit may be cleaned with a clean, soft cloth and a solution

consisting of mild detergent diluted in water. However, avoid coming in contact with open plugs and

connectors of any kind. Thoroughly wipe the exterior of the Cavaterm™ central unit and dry it with a

clean, soft cloth or paper towel.

Battery and charger

See section regarding maintenance of the batteries and charger.

Annual Maintenance

In order to operate safely and without any interruptions the system needs to be serviced at regular intervals.

Every 75 treatments or once a year (whichever comes first), the central unit has to be sent in for a check-up

(small service), where cleaning as well as basic mechanical and electronic adjustments will be performed.

This service will be performed by personnel trained by Pnn Medical.

Every three years, the system has to be sent to Pnn Medical for a thorough service. This service includes a

control of the mechanical moving parts, capacity check of the batteries, replacement of defective parts, and

thorough testing. This service includes also several critical adjustments, requires access to non-user

serviceable parts, and can only be performed by properly trained authorised personnel.

The need for service is indicated automatically by the message 'SEND FOR SER' when switching on the

central unit.

Recycling the central unit and the batteries

The central unit and the batteries located must be returned to the distributor or the manufacturer for

recycling after usage. The central unit and the batteries must be recycled or disposed of properly. Do not

dispose of in fire!

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