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USER MANUAL

BSLAB07_v18_ EN

Biosurgical S.L., part of Combat Medical Group

Page 33 of 39

13

MANUFACTURER AND TECHNICAL SERVICE

The system must be repaired exclusively by the Official Technical Service appointed by
Combat Medical. The user must not attempt to fix any problem with the system.

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

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Summary of Contents for COMBAT MEDICAL PRS+

Page 1: ...USER MANUAL BSLAB07_v18_ EN Biosurgical S L part of Combat Medical Group Page 1 of 39 COMBAT PRS HIPEC System USER MANUAL Manufactured by BIOSURGICAL S L...

Page 2: ...on 5 5 4 Associated Consumables 6 5 5 Safety System and Alarms 6 6 SYSTEM INSTALLATION 10 7 DISPOSABLE KIT 11 8 USE AND OPERATION 12 8 1 Home Screen 13 8 2 Mounting of Disposable Kit 15 8 3 Preheating...

Page 3: ...ating and recirculation of the fluid at a flow rate of 1200ml min 5 with temperature control of 1 C for the duration of the treatment This product is indicated for use in patients who have been diagno...

Page 4: ...system or if it is affected by EMC disturbances the system will not physically harm the patient In the worst case the treatment will stop The necessary instructions to maintain basic safety and essen...

Page 5: ...from the moment when recirculation starts depending on the amount of liquid to be heated usually 3000 4000ml The system has an operating mode and a recirculation time that can be controlled by the us...

Page 6: ...a redundant system of temperature sensors and electronic safety sensors that are independent from the disposable kit probes and which act directly on the heating elements deactivating them if the tem...

Page 7: ...saying Ensure that the temperature in the abdominal cavity is being monitored and it will request confirmation The alarms will adjust with respect to the set temperature as follows More than 44 C and...

Page 8: ...of 43 C or less There is an acoustic and visual high priority alarm if the system does not heat up If the user increases the set temperature to over 43 C the temperature alarm will activate at 2 C ov...

Page 9: ...ver 460mmHg in any of the processes Preheating Field filling Treatment or Field washing o Acoustic and visual high priority alarm The pump stops and moves back to reduce the pressure in the circuit Pu...

Page 10: ...ently sturdy and large to ensure that it will not fall off 1 Check the system s identification label to make sure that the system s power supply voltage matches the voltage of the country in which the...

Page 11: ...s 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 The...

Page 12: ...Medical Group Page 12 of 39 8 USE AND OPERATION The software programme follows the following flow diagram which is explained below Access screen Preheating Mounting of disposable set Treatment Field f...

Page 13: ...up Page 13 of 39 8 1 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 cl...

Page 14: ...R MANUAL BSLAB07_v18_ EN Biosurgical S L part of Combat Medical Group Page 14 of 39 The icons that appear on the screen are to access the following functions Programme version Settings menu Switching...

Page 15: ...processes listed below in order Expandable Assembly Preheating Field Filling Treatment Field Emptying and Field Washing Additionally a menu that will be explained later can be accessed 8 2 Mounting of...

Page 16: ...USER MANUAL BSLAB07_v18_ EN Biosurgical S L part of Combat Medical Group Page 16 of 39...

Page 17: ...USER MANUAL BSLAB07_v18_ EN Biosurgical S L part of Combat Medical Group Page 17 of 39 Press the Back button to go back to the previous step...

Page 18: ...henever this process is underway the timer will update on an ongoing basis Preheating will take place to the set temperature selected by the user 43 C by default changeable between 20 C and 45 C The t...

Page 19: ...e accessed by pressing the corresponding button The Emergency Stop button can be used during any of the treatment processes and will activate the stoppage and closing of the critical components perist...

Page 20: ...although experiments have shown that there is no fixed relationship between the entry and exit temperatures of the liquid as this is a detail that varies greatly between one patient and another The em...

Page 21: ...recirculation is in operation For this reason the Administer Chemotherapy group is only enabled when the pump is in operation Pressing the Abort button stops the treatment and the user has to restart...

Page 22: ...responding button Press the Back button to go back to the treatment screen The emergency stop button can be used during any of the treatment processes and will activate the stoppage and closing of the...

Page 23: ...ramme 8 7 Field Washing The purpose of this step is to remove any remaining medication that may have been left in the patient even after having emptied the field in the previous step once the recircul...

Page 24: ...components peristaltic pump turbine and clamps The treatment will not restart automatically the user must manually re activate the programme 8 8 Menu The menu can be accessed at any time by pressing t...

Page 25: ...USER MANUAL BSLAB07_v18_ EN Biosurgical S L part of Combat Medical Group Page 25 of 39...

Page 26: ...USER MANUAL BSLAB07_v18_ EN Biosurgical S L part of Combat Medical Group Page 26 of 39...

Page 27: ...ing an alarm it will emit the corresponding acoustic signal according to regulation IEC 60601 and there will be a flashing button at the top left of the screen in addition to a dialogue box with text...

Page 28: ...reatment will be required The alarms will adjust with respect to the set temperature as follows More than 44 C and less than 45 C for 15 seconds in the irrigation probe the alarm will activate one deg...

Page 29: ...and visual high priority alarm The pump stops and moves back to reduce the pressure in the circuit Pump cover open alarm Acoustic and visual high priority alarm The peristaltic pump and turbine stop...

Page 30: ...aks involving chemotherapy products the safety protocol established by the hospital must be followed If liquid penetrates the inside of the system do not attempt to disassemble it Notify technical ser...

Page 31: ...face cables 3 interface cables for temperature probes 3 6m in length and with a thickness of 3 5mm Temperature control Microprocessor control and electronic temperature sensors Leakage current UL 6060...

Page 32: ...ste Disposable kit specifications Kit manufactured by BIOSURGICAL S L SAFETY SYSTEM Electrical Risk Classification Class I Type B Degree of Protection against penetration by fluids IPX2 Operating Mode...

Page 33: ...ly by the Official Technical Service appointed by Combat Medical The user must not attempt to fix any problem with the system LEGAL MANUFACTURER BIOSURGICAL S L Ctra Torrej n Ajalvir Km 5 2 28867 Ajal...

Page 34: ...E PROTECTION CONSULT INSTRUCTIONS FOR USE HAZARDOUS VOLTAGE ALTERNATING CURRENT CLASS B SYSTEM ELECTRICAL RISK CLASSIFICATION DO NOT TIP THE SYSTEM NOTE IMPORTANT PRECAUTION FOR SAFE USE OF THE SYSTEM...

Page 35: ...ecommended below according to the maximum output power Maximum output power assigned to the transmitter W Separation distance according to transmitter frequency 150KHz to 80 MHz d 1 17 P 80MHz to 800...

Page 36: ...cluding domestic establishments and those connected directly to the public low voltage power supply providing electricity to residential buildings Harmonic emissions IEC 61000 3 2 Standard Class A Vol...

Page 37: ...ltage dips short interruptions and variations of the power supply IEC 61000 4 11 Standard 5 UT 95 UT dip in 5 periods 40 UT 60 UT dip in 5 periods 70 UT 30 UT dip in 25 periods 5 UT 95 UT dip in 5 sec...

Page 38: ...000 4 3 Standard 3Veff 150KHz to 80MHz 3V m 80MHz to 2 5GHz 3V 3V m 80MHz to 2 5GHz Laboratory accredited up to 1GHz Portable and mobile RF communications devices should not be used any closer to any...

Page 39: ...and land mobile radios amateur radio stations in addition to AM FM radio and television broadcasting stations cannot be accurately predetermined An on site study should be considered to determine the...

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