THE CAVATERM PLUS CENTRAL UNIT Operators Manual Rev F

Cavaterm Plus Central Unit – Operator‟s Manual

Table of Contents 1

CAVATERM™ SYSTEM ... 3 1.1 1.2 1.3 1.4 1.5

2

TREATMENT FOR DYSFUNCTIONAL UTERINE BLEEDING ... 3 HOW TO USE THIS MANUAL ... 3 WARNINGS ... 3 PRECAUTIONS ... 4 RESPONSIBILITY OF THE MANUFACTURER ... 4

GETTING STARTED ... 5 2.1 PACKING MATERIAL ... 5 2.2 TRANSPORT SAFETY SWITCH ... 5 2.3 POWER SUPPLY ... 5 2.4 FRONT PANEL ... 6 2.4.1 Indicator displays and operator keys ... 6 2.5 TREAMENT TIMER... 8 2.6 FACTORY SET PARAMETERS... 8 2.7 MAINS CONNECTION ... 8

3

OPERATION AND FUNCTIONS DURING THE PROCEDURE ... 9 3.1 3.2 3.3 3.4

4

CENTRAL UNIT TROUBLE-SHOOTING ... 11 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10

5

SEND IN FOR SERVICE ... 11 CATHETER USED ... 11 CATHETER EXPIRED ... 12 CATHETER DEFECTIVE ... 12 PRESSURE ABOVE MAXIMUM LIMIT 300 MMHG (CIRCULATION/HEAT NOT ACTIVATED) ... 12 HIGH PRESSURE WARNING (CIRCULATION/HEAT ACTIVATED) ... 12 PRESSURE ABOVE MAXIMUM LIMIT 320 MMHG (CIRCULATION/HEAT ACTIVATED) ... 13 LOW PRESSURE WARNING (CIRCULATION/HEAT ACTIVATED) ... 13 SUDDEN PRESSURE DROP ... 13 EMERGENCY CATHETER RELEASE ... 13

3-STEP CHARGER FOR INTERNAL BATTERY... 14 5.1 5.2

6

PRE-PREPARATION (ONLY FOR USE WITH BATTERY SOURCE) ... 9 PREPARATION ... 9 TREATMENT ... 10 END OF THE TREATMENT ... 11

CHARGING THE INTERNAL BATTERY ... 14 VERIFYING BATTERY CHARGE ... 14

EQUIPMENT SYMBOLS ... 15 6.1 6.2 6.3

IDENTIFICATION LABEL ... 15 INFORMATION LABEL ... 15 TRANSPORTATION SAFETY SWITCH LABEL ... 15

7

TECHNICAL SPECIFICATIONS CAVATERM™ PLUS CENTRAL UNIT ... 16

8

MAINTENANCE, CLEANING, PREVENTIVE INSPECTION AND DISPOSAL ... 17 8.1 8.2 8.3 8.4

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BEFORE EACH TREATMENT ... 17 CLEANING THE EXTERIOR ... 17 SERVICE MAINTENANCE ... 17 RECYCLING THE CENTRAL UNIT AND THE INTERNAL BATTERIES ... 17

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Cavaterm Plus Central Unit – Operator‟s Manual

1

CAVATERM™ SYSTEM

1.1

Treatment for Dysfunctional Uterine Bleeding

The Cavaterm™ system is a minimally invasive treatment for dysfunctional uterine bleeding that is based on heat in combination with pressure. The Cavaterm™ system consists of two parts, a single-use balloon catheter and a stationary central unit.

Cavaterm system (catheter and central unit) The Cavaterm™ plus central unit is a control device intended for use together with the Cavaterm plus catheter. A pump unit is also integrated into the Cavaterm™ plus central unit. This device will provide a vigorous circulation of the fluid located inside the balloon. During the treatment, the central unit controls the treatment parameters and displays them 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 pre-programmed. The treatment procedure is very easy to learn and can be carried out by pressing three keys. 1.2

How to use this manual

This manual describes the operational functions of the Cavaterm plus 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 catheter '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

The Cavaterm system is engineered for safe and reliable operation. Please help us ensure continued safe use of the equipment, by carefully reading the information in this section and the “Precautions” section (see also sections “Warnings” and “Precautions” of the document 'Instructions for Use' of the Cavaterm™ plus catheter) and by regular checks and maintenance. 

Do not operate the system if you detect external damage to the central unit or the 3 prong power cord.



It is necessary to earth the device appropriately in order to protect from electrical shock.



Any disconnection to the earth line can possibly cause danger of electrical shock.

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Cavaterm Plus Central Unit – Operator‟s Manual 

Do not use an adapter which changes the 3 prong plug to a 2 prong plug.



Do not attempt to open the Cavaterm plus central unit; doing so might lead to potential hazards. There are no user serviceable parts inside the central unit.



Do not dispose the internal batteries in fire.



All accessories should comply with EN 60601-1-1:1993 standard. If any doubt, contact customer service department or local representative office.



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.

1.4

Precautions



The Cavaterm system is to be used only by qualified physicians who have received appropriate training regarding the use of the system.



If the Cavaterm™ plus 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.



If there is doubt in the integrity of the protection to the earth line, internal power supply (battery) should be used instead.



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 located inside must be returned to the distributor or the manufacturer for proper disposal. 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: 

Staff authorised by Pnn Medical performs readjustments, modifications and training.

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Cavaterm Plus Central Unit – Operator‟s Manual

2

GETTING STARTED

2.1

Packing material

The unit is shipped in a cardboard box that includes the operator‟s manual. Please save all packing material in case the unit has to be returned to the distributor or manufacturer for service or upgrade. 2.2

Transport safety switch

Before operating the unit make sure that the transport safety switch is placed in the ON position. TM The switch can be found at the rear of the central unit. To set the switch, use a pen or similar object and slide the switch to the ON position.

term plus

2020-10 Version 1.0

RS232C

The switch should always be in the OFF position during shipment and storage to protect the dical SA Morges Switzerland electronics and the internal back-up battery. ing patents

0120

On

/ 50 - 60 Hz / 1.2 - 0.7 A

Pb

Off

Transportation Switc h

Transport safety switch 2.3

Power supply

The Cavaterm™ plus central unit can be either mains or battery operated. The central unit has an integrated power supply that adapts automatically to all mains voltages and frequencies between 100 to 240 VAC / 50 to 60Hz. Make sure to use the 3 prong mains cord supplied with the central unit. The central unit can also be battery operated, by disconnecting the unit from the mains. The central unit then uses the internal rechargeable battery. So, a treatment can also be guaranteed in case of a temporary mains power supply failure. If mains supply fails during treatment, the device will automatically switch to the battery. A fully charged battery will last for one treatment.

Mains connected display

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Battery operated display

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Cavaterm Plus Central Unit – Operator‟s Manual 2.4

Front panel

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

Pressure monitor Temperature and heating power indicator Treatment time

Treatment status

Main power

The central unit front panel 2.4.1

Indicator displays and operator keys

Below are the different indicators and keys described with their corresponding names and functions. The blue ON/OFF button is used to activate/deactivate the central unit. Keep the key pressed until the acoustic sound stops to activate the unit.

The green START button is used to activate the pump and heat.

The yellow STOP button is used to deactivate the acoustic signal noting at the end of the treatment and to release the catheter. It can also be used to stop the pump and heating at any time during the treatment.

BATTERY ON: Indicates that the battery power supply is being used.

CATHETER: A flashing light indicates that the central unit is ready to accept a catheter. Constant light indicates that the catheter is in place.

PUMP ON: Indicates that the pump is running.

HEAT ON: Indicates that the heating is active.

PRESSURE DISPLAY: Indicates the actual balloon pressure.

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Cavaterm Plus Central Unit – Operator‟s Manual

POWER AND TEMPERATURE DISPLAY WITH MODE SELECTOR: parameter was chosen for display.

A yellow light indicates which

MODE KEY: Used to select a parameter for display.

POWER: Indicates that the heating power is displayed.

TEMPERATURE: (by default at the beginning of the treatment). Indicates that the actual temperature of the fluid is displayed.

AVERAGE TEMPERATURE: (by default at the end of the treatment). Indicates that the average temperature calculated since the start of the treatment is displayed.

TIME DISPLAY WITH MODE SELECTOR: A yellow light indicates which parameter was chosen for display.

MODE KEY: Used to select parameters on the time display.

BOTH LED SWITCHED ON: (while unit in standby mode) Several parameters can be displayed after pressing the mode key repetitiously. Please see section 2.5.

NO LED SWITCHED ON: The total treatment time available for treatment is displayed.

UPPER LED ON: Remaining treatment time is displayed.

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LOWER LED ON: Already completed treatment time is displayed.

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Cavaterm Plus Central Unit – Operator‟s Manual 2.5

Treament timer

The function of the clock integrated in the central unit and the treatment counter can be verified by pressing the mode key on the time display. Press the time key repetitiously (8 times) to view the following information in this order: 1. Remaining treatment time available with the inserted catheter. When no catheter is inserted, this value equals 10.00 (upper LED 'on'). 2. Completed treatment time with the inserted catheter. When no catheter is inserted, this value is 00.00 (lower LED 'on'). 3. Total treatment time available before performing a treatment. 4. Minutes and seconds of clock (format MM.SS). 5. Hours and minutes of clock (format HH.MM). 6. Date (MM.DD). 7. Year (YYYY). 8. Number of treatments performed since last service of central unit. 2.6

Factory set parameters

The following parameters are factory set in the central unit (independent on the catheter settings which are described in the 'Instructions for Use'). 

Treatment time: 10 minutes; maximum heating up time 5 minutes



Balloon high pressure warning: 270 mmHg.

At a pressure above the warning level, an acoustic signal will sound. If the pressure remains at this level for more than 30 seconds, the system will stop the treatment. 

Maximum pressure: 300 mmHg (pump off) and 320 mmHg (pump on).

If a pressure above the maximum pressure is measured, then the central unit will immediately open the overpressure valve letting the fluid out of the drain tube of the catheter and stop the treatment. To restart the treatment, adjust pressure to 230 – 240 mmHg and repress the GREEN key. Note: The overpressure valve can be opened electronically as described above and mechanically as an additional safety in case of failing electronics. 

Low balloon pressure: 100 mmHg

If the pressure drops below this limit, an acoustic signal will sound. If the pressure remains below this level for more than 30 seconds, the system will stop the treatment. 

Target temperature: 78°C

2.7

Mains connection

The 3 prong plug is located at the rear of the central unit. Caution: Use only the 3 prong power cord delivered with the central unit for the connection with the mains outlet of a well maintained installation with protective earth.

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Cavaterm Plus Central Unit – Operator‟s Manual

3

OPERATION AND FUNCTIONS DURING THE PROCEDURE

3.1

Pre-preparation (only for use with battery source)

A. If planning to use the internal battery as a power source, charge the battery for 4 hours before the treatment (See section 5.1 Charging the internal battery). 3.2

Preparation

B. If planning to use a mains connection, ensure that the central unit is plugged to a mains outlet with protective earth. C. Turn transport safety switch to 'ON' position. D. Set the Cavaterm™ plus central unit into standby mode, by pressing the blue ON/OFF key firmly until the acoustic sound stops.

ON/OFF key and BATTERY POWER indicator Pressing the blue ON/OFF key will activate the Cavaterm™ plus central unit. An internal test (checksum test) will be performed. A welcome message is briefly displayed if no errors are detected, and then the standby message is displayed. Once in standby mode, the middle display indicates whether the machine is running on mains (AC) or on battery (bA) power. Furthermore, with the machine running on mains, the battery charging status is shown with dashes in the middle display. Three dashes indicate fully charged batteries. A treatment with battery power should only be started with fully charged batteries.

Welcome message

Mains standby message

Battery standby message

E. The “battery power” indicator will light if the central unit is running on battery. When the system has detected a weak battery, the battery indicator will blink and an acoustic signal will sound. Never start a new treatment session on battery power when this indicator is blinking. Use the mains connection instead.

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Cavaterm Plus Central Unit – Operator‟s Manual 3.3

Treatment

The following steps - catheter preparation - are described in the document 'Instructions for Use' available with the Cavaterm™ plus catheter. F. After turning the power on, the catheter indicator on the treatment status display starts flashing. This indicates that the unit is ready to accept a catheter.

Treatment status display G. The Cavaterm™ plus catheter connects to the central unit by inserting the catheter connector into the central unit (flat connector surface upwards). The pump compartment closes (humming sound from the motor which drives the circulation) and all necessary connections for heating, pumping, measuring are automatically made. The catheter indicator lights constantly to indicate that the Cavaterm™ system is ready for use. Note: If the pump compartment does not close (no humming sound), 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 key once. This might occur if the catheter indicator is not flashing (i.e. a catheter was removed just before insertion in the uterus). H. Once the catheter has been prepared and the balloon is properly inflated inside the uterus, press the GREEN start key to activate the pump and the heating. The three LEDs on the treatment status display are lit which indicates an ongoing treatment.

Treatment status display During the heat up phase, HEAT is displayed on the heat indicator until 60°C is reached. The treatment timer will start running when a temperature of 65°C has been reached. The treatment timer will also start if this is not the fact within 5 minutes of heating.

Heat up phase

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Ongoing treatment

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Cavaterm Plus Central Unit – Operator‟s Manual Note: If the treatment has to be interrupted for any reasons, press the YELLOW stop key once. Pressing the GREEN start key can then restart the treatment. I.

Heating will continue until the treatment time has elapsed. At the end of the treatment an acoustic signal sounds. Press the YELLOW stop key on the Cavaterm™ plus central unit to stop the acoustic signal.

J.

Once the balloon has been emptied, and the catheter removed from the uterus, press the YELLOW stop key again. A humming sound can be noted. When this sound has stopped, disconnect the Cavaterm™ plus catheter from the central unit. Note: It is only possible to remove the Cavaterm™ plus catheter from the pump if the balloon is empty and the pressure is below 30 mmHg.

K. Disconnection of the Cavaterm™ plus catheter is automatically detected by the central unit. It reverts to waiting for a new catheter; the catheter indicator on the treatment status display starts flashing. 3.4

End of the treatment

L. Press the blue ON/OFF key to deactivate the central unit. M. Turn off the transport safety switch at the rear of the central unit.

4

CENTRAL UNIT TROUBLE-SHOOTING

The central unit displays error and warning messages in order to help ensure a safe and effective treatment. These messages are described below, and include the action that should be taken in order to resolve the situation. A trouble-shooting flyer is available on a pull-out drawer under the central unit. 4.1

Send in for service Description: The central unit has not been serviced for 3 years. Action: 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.

SEnd For SEr 4.2

Catheter used Description: This catheter has already been used for a treatment. As the Cavaterm™ plus catheter is a single-use device, it cannot be re-used. Action: Press the YELLOW key once to stop the acoustic alarm. The message „Cat out‟ appears. Press the YELLOW key once more to release the catheter. Dispose.

CAt USEd F-02I14-F

If you know that the catheter has not been used: please return the catheter to Pnn Medical SA with a device complaint form and your comment. 11/17

Cavaterm Plus Central Unit – Operator‟s Manual 4.3

Catheter expired Description: This message means „Catheter expired‟. The Cavaterm™ plus catheter expires three years after production. Action: Press the YELLOW key once to stop the acoustic alarm. Press the YELLOW key once more to release the catheter. Dispose.

CAt EP 4.4

Catheter defective Description: The central unit has detected a problem with either an improperly purged catheter or the heating elements.

CAt DEFECt .

4.5

Action: A) If this occurs before starting the pump and heating: Press the YELLOW key once to stop the acoustic alarm. The message „Cat out‟ appears. Empty liquid from balloon. Press the YELLOW key once more to disconnect the catheter. Do not use the catheter. Return it to Pnn Medical SA with a device complaint form and your comment. B) If this occurs during the treatment: Press the YELLOW key once to stop the acoustic alarm. „Cat out‟ appears. Empty liquid from balloon and remove catheter from uterus. Press the YELLOW key once more to disconnect the catheter. Reinsert and repurge it. Resume treatment. If message reappears, return the catheter to Pnn Medical SA with a device complaint form and your comment.

Pressure above maximum limit 300 mmHg (Circulation/heat not activated) Description: High pressure may cause uterine rupture. The „Hi‟ message is blinking on the pressure display. Action: The central unit opens automatically the overpressure valve. Fluid is released through the drain tube of the catheter. The overpressure valve closes with a balloon pressure below 300 mmHg. The „Hi‟ Message disappears. Readjust pressure to 230 – 240 mmHg and continue procedure. Hi

4.6

High pressure warning (Circulation/heat activated) Description: High pressure may cause uterine rupture. Pressure above 270 mmHg. This alarm consists of an acoustic signal and the „Hi‟ message is blinking on the pressure display. Action: Gently pull out fluid from the balloon to reduce pressure to 230-240 mmHg.

Hi

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Cavaterm Plus Central Unit – Operator‟s Manual 4.7

Pressure above maximum limit 320 mmHg (Circulation/heat activated) Description: High pressures may cause uterine rupture. This alarm stops circulation/heat immediately when 320 mmHg of pressure is reached, opens the overpressure valve to evacuate the fluid from the balloon and activates an acoustic alarm.

StoP 4.8

Action: Wait for pressure to drop below 320 mmHg (automatically done by the overpressure valve evacuating fluid from the balloon). Verify pressure and readjust with the syringe, if necessary. Press the GREEN key to resume the treatment.

Low Pressure warning (Circulation/heat activated) Description: Pressure below 100 mmHg. Low pressures may result in inefficient treatment. This alarm consists of an acoustic signal and the „Lo‟ message is blinking on the pressure display. Action: Gently inject fluid to increase pressure to 230 - 240 mmHg.

Lo 4.9

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.

Sudden pressure drop Description: This alarm is activated when pressure in the balloon has dropped very fast and remains at a low level. This may be due to a ruptured balloon, a uterine rupture or a mechanical problem.

CAt BAL StoP

Action: Stop the acoustic alarm by pressing the YELLOW key. Empty liquid from balloon and remove 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 and ON. If everything OK, check integrity of uterus with hysteroscope. If everything OK, resume treatment.

4.10 Emergency catheter release In the very rare case of a blocked catheter in the central unit, an emergency button will open the catheter compartment in the central unit. The catheter can then be released. Please proceed as follows: E m e r g e n c y C a t h e t e r R e l e a s e F 0 4 G 0 1 A

Insert a pen or another instrument (maximum diameter 3 mm) into the hole located on the bottom of the right hand side of the central unit (see above) and press simultaneously the blue key. The pump compartment opens. Release catheter and then release BLUE key and the emergency button. Reset the central unit by switching the transportation switch to OFF, then to ON again if the central unit needs to be used again. F-02I14-F

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Cavaterm Plus Central Unit – Operator‟s Manual

5

3-STEP CHARGER FOR INTERNAL BATTERY

5.1

Charging the internal battery

The central unit is equipped with an integrated 3-step charger. In order to charge the internal battery, connect the central unit to the mains and ensure that the transport safety switch is in the 'ON' position. Leave the central unit on for approximately 4 hours. 5.2

Verifying battery charge

The partial charge of the battery can be verified. Connect the central unit to the mains. Press the BLUE ON/OFF key for a few seconds to activate the central unit. The degree of charge of the battery is indicated with 1 to 3 dashes on the middle display together with the indication AC (mains connected).

Low battery

Partially charged

Fully charged

The batteries are fully charged when the middle display indicates AC together with three superposed dashes.

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Cavaterm Plus Central Unit – Operator‟s Manual

6

EQUIPMENT SYMBOLS

Three information labels are placed at the rear of the Cavaterm plus central unit. On these labels different symbols are found. The symbols have the following meaning and purpose. 6.1

Identification Label

VERSION: Denotes the hardware version.

SERIAL NUMBER: For this specific central unit. Identified with 5 digits.

CavatermTMplus

SIGNATURE OF QUALITY CONTROL OFFICER: Identifies Quality Controller who performed the final test on the central unit. The signature is a confirmation that the unit has received an internal approval.

SN QC

Mode l CAV 2020-10 Version 1.0 Manufacture d by

Pnn Med ical SA Morg es Switzerland

0120

Pate nts and p ending p atents

CE-MARK: Indicates that the Quality Management System of Pnn Medical SA has been assessed by the Notified Body 120, and the Cavaterm ™ system complies with the EU Council Directive 93/42/EEC for Medical Devices.

6.2

DATE OF MANUFACTURE: Notes year, month and day (format YYYY-MM-DD) the Cavaterm™ plus central unit passed the final inspection.

Information label

TYPE BF / Class I EQUIPMENT: Indicates the unit has been approved as a type BF / Class I equipment.

T2AH/250V T3.5AH/110V

Pb

110 - 230 V / 50 - 60 Hz / 1.3 - 0.7 A

CAUTION: High Voltage

6.3

Read the Operator‟s Manual!

FUSES: Mains fuses 230V: 2 x 2 A (Slow Blow) 110V: 2 x 3.5 A (Slow Blow)

RECYCLE & Pb: Contains lead acid batteries. Please dispose of properly. See section 8.4

Transportation safety switch label

TRANSPORTATION SAFETY SWITCH: Indicates whether or not the central unit is ON or OFF.

vatermTM plus

CAV 2020-10 Version 1.0

ATTENTION: SEE INSTRUCTIONS n Medical SA FOR Morges Switzerland USE: Indicates that a0120 printed user's d pending patents instruction (operator‟s manual) is supplied together with the Cavaterm plus central unit. This operator‟s manual Pb the information, read 40 V / 50 - 60 contains Hz / 1.2 - important 0.7 A instructions carefully before using the system.

RS232C

red by

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On

Off

Transportation Switc h

RS232C: Indicates type of serial interface cable needed to connect to central unit. Only to be used by authorised Pnn Medical staff for maintenance. Must not be connected during treatment.

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Cavaterm Plus Central Unit – Operator‟s Manual

7

TECHNICAL SPECIFICATIONS CAVATERM™ PLUS CENTRAL UNIT Size (L * W * H) Weight Power source

Safety

450 * 310 * 120 mm 8000 g Mains Connection 110 - 230 V~ 50 – 60 Hz 1.3 A at 110 V 0.7 A at 230 V Fuses at 110 V: 2 x 3.5 AT (slow blow) Fuses at 230 V: 2 x 2 AT (slow blow) Type BF / Class I 3 prong power cord for protective earth connection

Internal battery

Lead acid battery – 2.0 Ah/24 V

Recharge time

4 – 5 hours for the batteries

Working and storage temperature Working and storage humidity range Transportation conditions

Between 10°C and 35°C 20 to 70% RH Transportation safety switch OFF Temperature range 10 to 35°C Humidity Range 20 to 70% RH

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Cavaterm Plus Central Unit – Operator‟s Manual

8

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. 8.1

Before each treatment

If planning to use battery source, ensure that the batteries are properly charged. 8.2

Cleaning the exterior

The exterior of the Cavaterm plus 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™ plus central unit and dry it with a clean, soft cloth or paper towel. 8.3

Service maintenance

In order to operate safely and without any interruptions, the system needs to be serviced at regular intervals. Once a year, the central unit has to be checked: cleaning, mechanical and electronic adjustments will be performed. Personnel trained by Pnn Medical will perform this service. 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 battery, 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 the three year service is indicated automatically by the message “SEnd For Ser” when switching on the central unit. 8.4

Recycling the central unit and the internal batteries

The central unit and the batteries located inside must be returned to the distributor or the manufacturer for proper disposal. Do not dispose of in fire!

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