Operators Manual
22 Pages
Preview
Page 1
THE PRESENT DOCUMENT HAS TO BE STORED IN THE COMPARTMENT LOCATED UNDER THE CAVATERM™ 3 CENTRAL UNIT
Operator’s Manual
3rd generation central unit
Pnn Medical SA Avenue Riond-Bosson 14 1110 Morges Switzerland Phone +41 21 8049900 Fax +41 21 8049901 www.cavaterm.com
DISCLAIMER Responsibility of the manufacturer Pnn Medical SA is responsible for the safe operation, reliability and performance of the Cavaterm™ 3 central unit only if qualified and authorized staff perform readjustments, modifications, upgrades, services and users training.
The Cavaterm™ 3 central unit is for professional use only.
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Operator’s Manual Table of contents 1.
How to use this operator’s manual……………………………………………………………. 04
2.
Product description………….……..…..……………………………………………………...
05
3.
Warnings and precautions……………………………………………………………………. 3.1 Warnings………………………………………………………….………………………. 3.2 Precautions……………………………………………………….……………………….
06 06 06
4.
Presentation of the system……………………………………………………………………. 07 4.1 The Cavaterm™ 3 Central Unit………………………………………………………….. 07 4.2 Packing material…………………………………………………………………………… 08 4.3 Equipotential ground terminal connector……………………………………………….. 08 4.4 Mains switch and power supply…………………………………………………………. 08 4.5 Front panel………………………………………………………………………………… 09 4.6 Remaining treatment time display…………………………………………………………. 11 4.7 Factory set parameters………………………………………………………………….. 11
5.
Procedure………………………………………………………………………………………. 5.1 Preparations………………………………………………………………………………. 5.2 Treatment…………………………………………………………………………………. 5.3 End of treatment………………………………………………………………………….
13 13 14 15
6.
Central unit troubleshooting……………..…………………………………………………….
16
7.
Maintenance…………………………………………………………………………………… 7.1 Cleaning…………….…………………………………………………………………….. 7.2 Changing the central unit fuses………………………………………………………… 7.3 Service maintenance……………………………………………………………………. 7.4 Recycling the central unit………………………………………………………………..
18 18 18 19 19
8.
Technical specifications and equipment symbols.……………………………………….… 8.1 Technical specifications…………………………………………………………………. 8.2 Equipment symbols……………………………………………………………………….
20 20 21
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1
How to use this operator’s manual
The present manual describes the Cavaterm™ 3 central unit and its operational functions. For the description of the Cavaterm™ plus catheter and its operational functions, see the document “Instructions For Use” delivered with the catheter. You must read both documents completely before operating the system. If your Cavaterm™ 3 central unit is equipped with the software version Cavaware 2.1, please pay special attention to the addendum placed in the document “Instructions For Use”. The procedure steps have changed due to a new purging process associated with the Cavaware 2.1. The software version of your central unit is mentioned on the enclosed declaration of conformity and it briefly appears on the information display when you activate the device by pressing the blue ON/OFF key (see figure below).
The terms and specifications mentioned in this manual refer to the items described in chapter 2 (Product description). Carefully read the sections 3.1 “Warnings” and 3.2 “Precautions” in chapter 3. Then proceed by reading the remaining chapters and sections of the manual and the Cavaterm™ plus catheter Instructions For Use – referring to the descriptions in chapter 2 whenever necessary – before performing any treatment with Cavaterm™. Once you have received proper training and gained a working knowledge of the system, then use this manual as a reference guide. If you need further assistance regarding the use of the Cavaterm™ 3 central unit, please contact your supplier.
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2
Product description
The Cavaterm™ 3 Central Unit 1.
Equipotential ground terminal connector
2.
Mains connection
3.
Mains switch
4.
Reset
5.
Pump slot
6.
Front panel
7.
ON/OFF key
8.
Start key
9.
Stop key
10. Up key 11. Down key 12. Information display 13. Pressure indicator 14. Remaining treatment time display 15. Storage compartment for product documentation and mains power cord (located under the device) 16. 3 prong power cord
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3
Warnings and precautions
Cavaterm™ 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 (see also sections “Warnings” and “Precautions” of the document “Instructions For Use” of the Cavaterm™ plus catheter), as well as by regular checks and maintenance operations. 3.1
Warnings
Cavaterm™ is to be used only by qualified physicians who have received appropriate training regarding the use of the system.
Do not operate the system if you detect external damage to the central unit or the 3 prong power cord; or if you suspect any internal damage or malfunction.
It is necessary to earth the device appropriately in order to guarantee protection against electrical shock.
To avoid risk of electrical shock, this equipment must be connected only to a supply mains with protective earth.
Any disconnection to the earth line can possibly cause danger of electrical shock.
Do not use any adapter which changes the 3 prong plug to a 2 prong plug.
Do not attempt to open the Cavaterm™ 3 central unit. Doing so might lead to potential hazard. There are no user serviceable parts inside the central unit.
Avoid excessive light exposure directly towards the Cavaterm™ 3 central unit front panel.
Do not block the drain tube of the catheter. The drain tube is part of the overpressure safety system, blocking it might result in overpressure and uterine rupture.
Never exceed a pressure of 240 mmHg. Overpressure may lead to uterine rupture.
The use of Cavaterm™ is appropriate only in rooms equipped for medical procedures.
No modification of this equipment is allowed.
3.2
Precautions
The Cavaterm™ 3 central unit is a device ensuring measurements and precision. Therefore it must be handled with appropriate care.
The Cavaterm™ 3 central unit and Cavaterm™ plus catheter have to be handled with the same precautions as any electrical equipment connected to the mains.
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 any doubt, contact a qualified technician or your supplier.
If the Cavaterm™ 3 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.
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3.2 Precautions (cont.)
After pressing the blue ON/OFF button, an internal test will be automatically performed and every indicator will briefly light up one by one. If any of the indicators does not light up, reconsider using the device and contact your supplier.
Do not insert any other object than the Cavaterm™ plus catheter base inside the Cavaterm™ 3 central unit pump slot.
When a catheter is inserted, the pressure shown on the information display before removal of the luer cap should be inferior or equivalent to 10 mmHg; if a higher value is displayed, send the central unit to your supplier for service.
During each Cavaterm™ treatment, the Cavaterm™ 3 central unit has to be placed approximately at the same level above the floor as the lying patient.
If the Cavaterm™ 3 central unit is not going to be used anymore, it must be returned to the distributor or the manufacturer for proper disposal. Do not dispose of in fire.
Be aware of the notes inserted in the present operator’s manual when using the Cavaterm™ 3 central unit.
If the Cavaterm™ 3 central unit does not function as described in the present operator’s manual, please do not use it and contact your supplier.
The Cavaterm™ 3 central unit must be serviced every 3 years.
4.
Presentation of the system
4.1
The Cavaterm™ 3 central unit Cavaterm™ is a minimally invasive system for the treatment of dysfunctional uterine bleeding. It consists of two parts: a sterile, single use balloon catheter (product reference CAV 2010-10) and a central unit (product reference CAV 2020-20). Cavaterm™ 3 central unit is a control device intended for use together with the Cavaterm™ plus catheter. A pump unit is integrated into the device and provides vigorous circulation of the fluid 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, such as treatment duration and temperature, are preprogrammed. The treatment procedure is carried out by pressing three keys: the ON/OFF key, the green Start key and the yellow Stop key. The steps to take (brief instructions for use) are displayed on the central unit information display before and during the treatment.
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4.2
Packing material The Cavaterm™ 3 central unit is shipped in a cardboard box – or in a suitcase – that includes the present operator’s manual. Keep all packing material in case the central unit has to be returned to your Cavaterm™ distributor or to the manufacturer for service or for upgrade.
4.3
Equipotential ground terminal connector It is located on the rear panel of the central unit and it can be used for connection to an equipotential plug in order to bring various systems or parts of systems to the same potential. Please use appropriate cable and plug and refer to your technical department for specific recommendations.
4.4
Mains switch and power supply Before operating the central unit, make sure that the mains switch is placed in the ON position. When the central unit is not used (during storage or transportation), make sure that the mains switch is placed in the OFF position. The mains switch is located at the rear of the central unit.
The mains switch has to be turned off for device storage or transportation The Cavaterm™ 3 central unit is mains operated. The central unit has an integrated power supply that adapts automatically to all mains voltages and frequencies from 110-230 VAC, 50-60 Hz, 1.3-0.6 A. Make sure to use the 3 prong mains cord supplied with the central unit in order to ensure system safety and efficiency.
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4.5
Front panel The system is operated from the keys located on the central unit front panel. 1. ON/OFF key
8 1 2
7
2. Start key 3. Stop key 4. Up key 5. Down key
6
4 5
3
6. Information display 7. Pressure indicator 8. Remaining treatment time display
The Cavaterm™ 3 central unit front panel (shown before the device is turned on) The different keys and indicators are described below and on the next page
The blue ON/OFF key is used to activate and deactivate the central unit. To turn on the central unit, press it until the acoustic sound stops.
The green Start key is used to activate the pump for circulation and the heating system.
The yellow Stop key is used to release the catheter. It can also be used to stop the pump and heating at any time during the treatment.
The Up and Down keys are used to scroll up or down the instructions or indications on the information display.
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This display indicates the remaining treatment time. When the treatment temperature reaches 65° C, the countdown starts and goes from 10 minutes to 0 seconds (end of the treatment). The pressure indicator shows the current treatment pressure range as follows The current pressure is within optimal range The current pressure is above the optimal range and should be adjusted
The current pressure is too high and has to be adjusted immediately The current pressure is very high / too high and has to be adjusted immediately The current pressure is somewhat below optimal range The current pressure is below optimal range The current pressure is low and has to be adjusted
The current pressure is very low and has to be adjusted
The information display shows the following information during the treatment: Ongoing temperature (°C) in the catheter Ongoing pressure (mmHg) Target pressure (mmHg) Warning or error message if necessary The information display shows the following information when no treatment is running: Date and time (CET: Central Europe Time = GMT +1) Date of next service Software version (briefly displayed)
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4.6
Remaining treatment time display The remaining treatment time display indicates 10:00 (10 minutes) once a new catheter has been inserted. The timer begins decreasing once the temperature of 65°C has been reached in the balloon. At the end of the treatment (10 minutes) the remaining treatment time display turns off.
4.7
Factory set parameters The parameters described below are factory set for maximal safety and efficiency. Parameters set in the catheter: •
Treatment time: 10 minutes
•
Warning signal in case of high balloon pressure: from 270 mmHg and above
If the pressure reaches or exceeds 270 mmHg, an acoustic signal sounds and the pressure has to be adjusted to a value below 270 mmHg within 30 seconds. If the pressure keeps being above 270 mmHg for more than 30 seconds, the treatment will be interrupted. At that stage the circulation and heating stop immediately. You can adjust the pressure to the optimal range of 230-240 mmHg or at least to a minimum of 160 mmHg if the optimal pressure range cannot be reached. Then press the green Start key again in order to resume the treatment. •
Warning signal in case of low balloon pressure: below 160 mmHg
If the pressure drops below this limit, an acoustic signal sounds. At that stage, you have to adjust the pressure to the optimal range of 230 to 240 mmHg or at least to a minimum of 160 mmHg if the optimal pressure range cannot be reached. The warning signal will stop as soon as the pressure reaches 160 mmHg again. •
If the pressure keeps being below 100 mmHg for 30 seconds, the treatment will be interrupted. At that stage the circulation and heating stop immediately. You can adjust the pressure to the optimal range of 230-240 mmHg or at least to a minimum of 160 mmHg if the optimal pressure range cannot be reached. Then press the green Start key again in order to resume the treatment.
•
Target temperature: 78° C
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Parameters set in the central unit: •
Maximal heating up time: 5 minutes If the temperature does not reach 65° C after 5 minutes, the treatment is inefficient and therefore will be interrupted.
•
Starting pressure: 160-240 mmHg
The treatment can be started only with a pressure of 160-240 mmHg. If the pressure is below or above these values, you have to adjust it before pressing the green Start key. •
Target pressure: 230-240 mmHg (green pressure indicator)
•
Maximal pressure: 300 mmHg If the pressure gets higher than 300 mmHg, the central unit will immediately stop and open the overpressure valve letting fluid out of the catheter drain tube. To continue the interrupted treatment, adjust the pressure to 230-240 mmHg, or at least to a minimum of 160 mmHg if the optimal pressure range cannot be reached, and press the green Start key again.
Note:
the overpressure valve will be opened electronically as described above and mechanically as an additional safety feature in case of electronic failure at a pressure of 33010 mmHg.
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5.
Procedure
5.1
Preparations • Ensure that the central unit is plugged to a mains outlet with protective earth • Ensure that the 3 prong power cord delivered with the central unit is used for the connection with the mains outlet of a well maintained installation with protective earth • Turn mains switch to the ON position
Mains switch and mains connection • Set the Cavaterm™ 3 central unit into the standby mode by pressing the blue ON/OFF key firmly until the acoustic sound stops.
ON/OFF key Pressing the blue ON/OFF key will activate the Cavaterm™ 3 central unit. An internal test will be performed each time the central unit is turned on. All light emitting diodes (LEDs) will be switched on and off one by one. A welcome message is briefly shown on the information display if no errors are detected. It is immediately followed by the standby message, which displays the following information: -
Date and time Due date for next service Instruction: Green “Start” key to continue
Standby message on the information display
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5.2
Treatment • Press the green Start key to leave the standby mode and perform a treatment. The treatment instructions are continually shown on the information display.
You can also find the “Instructions For Use” brochure available with each Cavaterm™ plus catheter. • To connect the Cavaterm™ plus catheter to the central unit, insert the catheter connector into the central unit pump slot (flat connector surface upwards). The pump compartment closes (humming sound from the motor) and all necessary connections for heating, pumping and measuring are automatically made. Insertion of catheter connector The treatment time is indicated on the remaining treatment time display and the following information is available on the information display: Pressure: current pressure in mmHg Target pressure in mmHg: 230-240 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 still not close, shut down the central unit and start the procedure again. • Once the catheter has been prepared and the balloon is properly filled to the target pressure, press the green Start key to activate the circulation and the heating. Note: starting the treatment is only possible if the pressure is within range from 160 to 240 mmHg. • Use the following keys whenever necessary to navigate in the instructions or indications available on the information display. The sign is shown on the bottom right of the information display each time you have to scroll down in order to read more instructions.
Up and Down keys used to scroll up or down the
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instructions or indications on the information display. •
During the heat up phase “Heating process” is displayed on the information display until the temperature of 65° C is reached. The current temperature is then displayed.
The treatment timer starts running when the temperature in the catheter reaches 65° C. If the temperature does not reach 65° C after 5 minutes, the procedure will be interrupted. Note: if the treatment has to be interrupted for any reasons, press the yellow Stop key once. You can resume the treatment afterwards by pressing the green Start key. • Heating will continue until the treatment time has elapsed. At the end of the treatment, liquid heating and circulation stop, an acoustic signal will be heard for a few seconds. The average treatment pressure and temperature will be displayed on the information display.
• Empty the balloon, remove the catheter from the patient uterus, then press the yellow Stop key to disconnect the catheter from the central unit. A humming sound will be heard. You can remove the catheter after the humming sound has stopped. Note: removal of the Cavaterm™ plus catheter is only possible if the balloon is empty and the pressure below 30 mmHg. • Disconnection of the Cavaterm™ plus catheter is automatically detected by the central unit. 5.3
End of treatment • Press the blue ON/OFF key to deactivate the central unit. • Turn off the mains switch at the rear of the central unit.
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6.
Central unit troubleshooting The Cavaterm™ 3 central unit displays error and warning messages in order to help ensure a safe and effective treatment. These messages are described in Appendix 1 to be found on the internal back cover page of the present operator’s manual. Forced catheter release: in the very rare case of a blocked catheter in the central unit, a specific button will open the catheter compartment in the central unit.
Reset
The catheter can be released even with a pressure above 30 mmHg. Proceed as follows: Insert a pen or another instrument (maximum diameter of 3 mm) into the hole located at the rear of the central unit (see above picture). The pump opens and the central unit is reset. Retrieve the catheter from the slot. Check for possible causes and contact your supplier if the equipment (catheter or central unit) appears to be faulty. If the power supply should be interrupted for any reason during a treatment, the device will shut down. Empty the balloon and wait until the mains connection is back to normal. Press the blue ON/OFF key, retrieve the catheter from the pump slot. Follow the instructions on the information display in order to continue the procedure.
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In case you have to contact your supplier, as recommended in some situations described in the present manual, please provide your contact with the following information:
Your contact data
Catheter lot no.
Central unit serial no. (mentioned on the label located under the device)
Date of the event
If the device was used for a treatment, uterus length, cavity length and volume of fluid injected into the balloon
Whether the complaint is due to the catheter or the central unit
Warning or error number in case a warning or an error message was displayed on the central unit information display
When the event happened (before, during or after the procedure) and what was done
Any information that can be useful for case and device analysis
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7.
Maintenance This section contains preventive maintenance instructions for the Cavaterm™ 3 central unit. 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 for implementing a satisfactory maintenance schedule; if failing to do so, it may cause equipment failure and possible health hazards. If you have any questions or if anything unexpected happens in relation with the maintenance of the Cavaterm™ 3 central unit, please contact your supplier.
7.1
Cleaning The cover of the Cavaterm™ 3 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™ 3 central unit and dry it with a clean, soft cloth or paper towel.
7.2
Changing the central unit fuses The central unit fuses can be changed whenever necessary. Proceed as follows for a safe change of the fuses: - Turn off the mains switch and remove the 3 prong power cord. - Open the fuse compartment with a screwdriver.
lift here
-
Replace the old fuses with new ones, as specified in the safety section of table 8.1 on page 20 of the present operator’s manual. Close the fuse compartment by placing back the cover. If the replaced fuses need to be changed again within short time, please contact your supplier.
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7.3
Service maintenance Every three years, the system has to undergo a major service. This service includes a control of the mechanical moving parts, the replacement of defective parts and thorough testing. This service also includes several critical adjustments, requires access to non-user serviceable parts and must be performed by properly trained, certified and authorized personnel. As soon as the Cavaterm™ 3 central unit is due for service, a warning message reading “Send for service” appears automatically when switching on the device. At that stage, you can still perform the treatment but you have to contact your supplier in order to have a service performed on the device. 3 months after the service due date, the device gets automatically blocked and cannot be used anymore until it gets serviced. The date of the next service is shown in the standby message appearing after the welcome message on the information display.
7.4
Recycling the central unit The central unit must be returned to the distributor or the manufacturer for proper disposal. Do not dispose of in fire.
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8
Technical specifications and equipment symbols
8.1
Technical specifications
Size (L x W x H) Weight Power source
Safety
Operating temperature Operating humidity range Atmospheric pressure for operating Transportation and storage conditions
Pressure measurement accuracy Temperature measurement accuracy Treatment duration accuracy Pressure conversion
Expected service life
390 x 285 x 106 mm 5000 g Mains connection: 110-230 VAC 50-60 Hz 1.3-0.6 A Fuses: T2AH250V for 230 VAC T3.5AH125V for 110 VAC Type BF applied part Class I equipment Between 10° C and 40° C 20% to 70% Relative Humidity 0.7 Bar – 1.1 Bar 70 kPa – 110 kPa Mains switch in the OFF position temperature range -20° C to 50° C humidity range 20% to 70% atmospheric pressure 0.3 to 1.1 bar 10 mmHg at 240 mmHg +2/-4 ° C at 78° C 5 seconds 1 mmHg = 133.3 Pa 100 mmHg = 13332.2 Pa 230 mmHg = 30664.1 Pa 240 mmHg = 31997.4 Pa 270 mmHg = 35997 Pa 300 mmHg = 39996.7 Pa 20 years (with a service performed every 3 years)
For use with the Cavaterm™ plus catheter, reference 2010-10
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