Summary of Contents for BIOSURGICAL COMBAT MEDICAL PRS+
- Page 1 USER MANUAL BSLAB07_v18_ EN COMBAT PRS HIPEC System USER MANUAL Manufactured by BIOSURGICAL S.L. Page 1 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 2: Table Of Contents
Cleaning ............................30 10.2 Maintenance ..........................30 SYSTEM SPECIFICATIONS ......................31 WARRANTY ..........................32 MANUFACTURER AND TECHNICAL SERVICE ................ 33 DEFINITION OF SYMBOLS ......................34 EMC CONFORMITY TABLES ...................... 35 Page 2 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 3: Introduction
• To avoid the risk of electric shock, this system should only be connected to a power supply grid with grounding protection. • The system has an equipotential grounding conductor connected to the mains grounding of the building. Page 3 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 4: Precautions
• Do not cover the system with objects that could block its ventilation grilles. This could cause overheating and functional anomalies in its internal components. • The system must be kept in a dry place at a temperature between 10ºC and 35ºC. Page 4 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 5: Description Of System
• PCB electronic control • USB connector to extract the treatment data and perform maintenance operations • Peristaltic pump • Heating plates and resistors • 2 connectors for pressure monitoring cables Page 5 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 6: Associated Consumables
In selecting a set temperature of over 43ºC up to 45ºC, every 0.5ºC there will be a warning message indicating that "It is not advisable to work with temperatures over 43ºC for this type of treatment" and requesting confirmation. Page 6 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 7 • More than 44ºC and less than 45ºC, for 15 seconds, in the preheating or irrigation probes, the alarm will activate at one degree over the set temperature selected. Page 7 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 8 • There is an alarm for the disconnection or erroneous reading of the irrigation temperature probe, during the field filling, treatment and field washing processes. • Alarm for the disconnection or erroneous reading of the bag temperature probe, during the preheating process. Page 8 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 9 The peristaltic pump and turbine stop All the clamps will close. Once the pump cover is closed again, the process restarts where it left off when the cover was opened. Page 9 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 10: System Installation
3.- Press the “On” button and you will see the green light come on. After a few seconds, the touchscreen will come on and the programme will start running. Page 10 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 11: Disposable Kit
DISPOSABLE KIT The system is designed to work exclusively with the disposable kit supplied by Biosurgical S.L. The use of other disposable systems not compatible with the system may damage the system and/or harm the end user. -
Page 12: Use And Operation
The software programme follows the following flow diagram, which is explained below: Access screen Mounting of disposable set Preheating Field filling Treatment Field emptying Field washing Save data and turn Page 12 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 13: Home Screen
Enter the patient's initials (maximum of 5 digits) and patient number in the first screen of the programme and the treatment date. The first 3 fields are obligatory. By clicking on the box, the keyboard will appear to enter or modify the data. Page 13 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 14 USER MANUAL BSLAB07_v18_ EN The icons that appear on the screen are to access the following functions: Programme version Settings menu Switching off. Page 14 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 15: Mounting Of Disposable Kit
On the disposable kit assembly screen, the programme will provide guidance to mount it on the system. Every time a step is complete, acknowledge this on the machine by pressing the corresponding tick box. Page 15 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 16 USER MANUAL BSLAB07_v18_ EN Page 16 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 17 USER MANUAL BSLAB07_v18_ EN Press the “Back” button to go back to the previous step. Page 17 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 18: Preheating
During the whole preheating process, the temperature control software ensures temperature stability with an accuracy of ±1ºC with respect to the set temperature. Page 18 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 19: Field Filling
(peristaltic pump, turbine and clamps). The treatment will not restart automatically, the user must manually re-activate the programme. Field Filling Page 19 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 20: Treatment
Once again, readings from the irrigation and aspiration probes are shown. If the kit’s probes are not connected to the monitoring cable and this in turn to the system, it will not work. Page 20 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 21 The treatment time will depend on the judgement of the healthcare personnel and can be controlled using the timer on the screen. Page 21 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 22: Field Emptying
The emergency stop button can be used during any of the treatment processes and will activate the stoppage and closing of the critical components (peristaltic pump, turbine and clamps). The treatment will not restart automatically, the user must manually re-activate the programme. Field Emptying Page 22 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 23: Field Washing
If the probe is not connected to the monitoring cable and the cable to the system, the process will not be possible. Page 23 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 24: Menu
Press this icon to access the treatment data. It is also used to update the system and for the technical service. Calibration of probes, for use exclusively by Technical Service. Programme version information. Turn off the system. Page 24 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 25 USER MANUAL BSLAB07_v18_ EN Page 25 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 26 USER MANUAL BSLAB07_v18_ EN Page 26 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 27: Alarms
The button presented below displays the alarms that can be activated in the system. If several alarms are activated, the one of the highest priority will be displayed. Page 27 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 28 2ºC above the new set temperature selected. • There is an alarm for the disconnection or erroneous reading of the irrigation temperature probe, during the field filling, treatment and field washing processes Page 28 of 39 Biosurgical S.L., part of Combat Medical Group...
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Page 29: Cleaning And Maintenance
Do not submerge the system in cleaning or sterilisation liquids. The system is not designed for cleaning by immersion. Do not clean the system with harsh liquid solvents as these products might damage the casing, labelling or internal components. Page 29 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 30: Cleaning
Next, proceed to clean the system as indicated in point 10. 10.2 Maintenance Periodic inspections/checks of the system must be conducted at least every 12 months by the technical service or qualified personnel. Page 30 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 31: System Specifications
35 - 75% Pressure 100-70kPa Transport and storage conditions Temperature –5ºC - 70ºC Humidity 0% -90% Pressure 100-10kPa Environmental requirements Compliance with Directive 2011/65/UE(RoHS2) Compliance with Directive 2012/19/UE (WEE) Page 31 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 32: Warranty
Problems arising from improper use or faulty maintenance of the system are excluded. System accessories and disposable kits are excluded from this warranty. Page 32 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 33: Manufacturer And Technical Service
LEGAL MANUFACTURER BIOSURGICAL S.L. Ctra. Torrejón-Ajalvir Km 5,2 28867 Ajalvir Madrid SPAIN TECHNICAL SUPPORT COMBAT MEDICAL LTD Lamer House Office Lamer Lane Wheathampstead Herts AL4 8RL UNITED KINGDOM www.combatcancer.com @CombatCancer Page 33 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 34: Definition Of Symbols
IMPORTANT PRECAUTION FOR SAFE USE OF THE SYSTEM NOTE COMPLIANCE WITH DIRECTIVE 2012/19/EC (WEEE) WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT GROUNDING PROTECTION EQUIPOTENTIALITY COMPLIANCE WITH DIRECTIVE 2011/65/EC (RoHS 2) Page 34 of 39 Biosurgical S.L., part of Combat Medical Group... -
Page 35: Emc Conformity Tables
Note 1: At 80 MHz, the separation distance for the highest frequency range is applied. NOTE 2: These guidelines do not apply to all situations. Electromagnetic propagation is subject to absorption and reflection by structures, objects and people. Page 35 of 39 Biosurgical S.L., part of Combat Medical Group... - Page 36 If the floors Electrostatic discharges (ESD) are covered with IEC 61000-4-2 Standard synthetic material the ± 8kV air discharge ± 8kV air discharge relative humidity must be at least 30%. Page 36 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 37 (50/60 Hz) 3A/m 3A/m values found in the typical business and hospital environment. IEC 61000-4-8 Standard Note: UT is the AC supply voltage prior to application of the test level. Page 37 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 38 Interference may occur in the vicinity of any equipment bearing the following symbol: Page 38 of 39 Biosurgical S.L., part of Combat Medical Group...
- Page 39 The field strength should be less than 3V/m in the frequency range of 150kHz to 80MHz. Page 39 of 39 Biosurgical S.L., part of Combat Medical Group...
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