BIOSURGICAL COMBAT MEDICAL PRS+ User manual

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.

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Biosurgical S.L., part of Combat Medical Group Page 2 of 39
CONTENTS
1INTRODUCTION.............................................................................................................................3
2PURPOSE OF THE PRODUCT ........................................................................................................3
3USER QUALIFICATIONS................................................................................................................3
4WARNINGS AND PRECAUTIONS .................................................................................................3
4.1 Warnings.......................................................................................................................................3
4.2 Precautions....................................................................................................................................4
5DESCRIPTION OF SYSTEM............................................................................................................5
5.1 Thermal Control ............................................................................................................................5
5.2 Operating Mode.............................................................................................................................5
5.3 System Configuration ....................................................................................................................5
5.4 Associated Consumables................................................................................................................6
5.5 Safety System and Alarms .............................................................................................................6
6SYSTEM INSTALLATION ............................................................................................................10
7DISPOSABLE KIT..........................................................................................................................11
8USE AND OPERATION.................................................................................................................12
8.1 Home Screen ...............................................................................................................................13
8.2 Mounting of Disposable Kit .........................................................................................................15
8.3 Preheating....................................................................................................................................18
8.4 Field Filling.................................................................................................................................19
8.5 Treatment ....................................................................................................................................20
8.6 Field Emptying............................................................................................................................22
8.7 Field Washing..............................................................................................................................23
8.8 Menu...........................................................................................................................................24
9ALARMS........................................................................................................................................27
10 CLEANING AND MAINTENANCE...............................................................................................29
10.1 Cleaning......................................................................................................................................30
10.2 Maintenance ................................................................................................................................30
11 SYSTEM SPECIFICATIONS..........................................................................................................31
12 WARRANTY..................................................................................................................................32
13 MANUFACTURER AND TECHNICAL SERVICE ........................................................................33
14 DEFINITION OF SYMBOLS..........................................................................................................34
15 EMC CONFORMITY TABLES ......................................................................................................35

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1INTRODUCTION
The COMBAT PRS+HIPEC system is intended for the recirculation of irrigation fluids for
use in humans. The fluid is heated through a dry heat transfer system and recirculated using a
peristaltic pump at a recirculation flow rate of 1200ml/min ± 5%.
The system achieves the optimal temperature via heating plates and transfers this heat through
an exchanger in which the fluid circulates.
The system maintains the optimum temperature with 3 temperature sensors: one in the fluid
bag, one in the irrigation line and one in the aspiration line, in addition to four temperature
sensors located on the heating plates.
2PURPOSE OF THE PRODUCT
The system is intended for abdominal chemo-hyperthermia through the heating 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 diagnosed with invasive peritoneal
tumours, where hyperthermic irrigation with chemotherapy using the HIPEC technique is
recommended and is not suitable for other anatomical regions.
3USER QUALIFICATIONS
The system should be used by qualified healthcare professionals:
•Doctors
•Nurses
•Perfusionists
•Other appropriately trained healthcare professionals
4WARNINGS AND PRECAUTIONS
4.1 Warnings
•Once the system has been configured prior to treatment, no additional electrical
maintenance is necessary during the functioning process thereof.
•Danger of electric shock. Do not open the system.
•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.

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•Use exclusively with PRS disposable kits. The use of any other disposable kits could
damage the equipment and/or harm the patient.
•If any of the alarms are constantly activated, stop the treatment, turn off the system
and call Technical Service on [phone].
•The system should only be used by trained and authorised personnel according to the
instructions in this manual.
•Portable and mobile RF communication systems may affect the system.
•WARNING: The use of accessories and cables other than those specified and supplied
with the PRS system as replaceable parts could lead to an increase in the EMISSIONS
or a decrease in the IMMUNITY of the PRS in terms of Electromagnetic
Compatibility.
•WARNING: The PRS system must never be used next to or on top of any other
equipment. Should this be strictly necessary, the system must be monitored by the user
to ensure that it is functioning correctly.
•Even if there is a fault in one component of the 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 essential functioning with
respect to electromagnetic disturbances for the expected service lifetime are as
follows: Avoid the use of mobiles around the system.
•The system's USB port is designed for maintenance, repair and data extraction
purposes, the last being the only action to be carried out by the user.
•Maintenance and repair operations should be performed by Technical Service
technicians only and under no circumstances shall these activities take place during
operational use of the system.
•At the end of its life cycle, the system should be managed as electrical waste.
4.2 Precautions
•Do not tip the system.
•Danger of explosion. Do not use the system in the presence of flammable gases.
•Do not submerge the system in water or other cleaning liquids. Wipe the system with
a clean, damp cloth.
•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.

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•This system is only suitable for the treatment of peritoneal tumours using the HIPEC
Technique. This system is not suitable for the treatment of other types of cancer.
5DESCRIPTION OF SYSTEM
PRODUCT CODE
DESCRIPTION
COMPRS03
COMBAT PRS+HIPEC System, 220-240V, 50Hz, 1800W, 2x10A
COMPRS04
COMBAT PRS+HIPEC System, 100-120V, 50/60Hz, 1800W, 2x20A
5.1 Thermal Control
The thermal control principle of the system is based on the aluminium heat exchanger, which
is in direct contact with the heating plates. The heat exchanger through which the fluid
circulates fits between the heating plates. The temperature range of the system is 20ºC to 48ºC.
5.2 Operating Mode
The system will take approximately 10-15 minutes to reach and stabilise the fluid temperature
set on the system, 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 user
at a default temperature of 43ºC; the user can select the temperature up to 48ºC.
Regardless of the volume and flow rate, the system adapts automatically to ensure that the
fluid remains at the selected temperature.
The system is designed to be used in an operating theatre, on patients and under the
supervision of the user to control the correct functioning thereof.
5.3 System Configuration
System adjustment and operation is carried out using the touch screen, which is used to select
the different operating parameters.
The system principally consists of the following:
•Power switch
•8 external jack connectors to connect the temperature monitoring cables
•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

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•4 electronic safety temperature sensors
•Touchscreen
•2 fuses
•3 temperature monitoring cables
•1 pressure monitoring cable
•1 Stand
•1 CO2Chamber
•1 Clamp for CO2Chamber holding
The system has an accessory consisting of a wheeled cart specifically designed for the PRS+
system.
5.4 Associated Consumables
•Disposable kit
5.5 Safety System and Alarms
The safety system comprises 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 temperature is too high.
5.5.1 Alarms
•There will be an alarm triggered between 44ºC and 45ºC, for 15 seconds, during
the preheating, field filling, treatment and field washing processes. (when working
with a set temperature of 43ºC or less)
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.

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•After 45ºC and up to 48ºC the system will show a message 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 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.

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If the temperature selected is lowered again the alarm will stop until the heating plates
start to heat up again and at this point it will set itself at 1ºC above the new temperature
selected.
•There is an alarm for temperatures over 45ºC in the bag probe during the preheating
process or in the irrigation probe during the field filling, treatment and field washing
processes. (working with a set temperature of 43ºC 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 43ºC, the temperature alarm will
activate at 2ºC over the set temperature selected.
If the set temperature is lowered again, the alarm will stop until the heating plates start
to heat up again and at this point it will set itself at 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.
•Alarm for the disconnection or erroneous reading of the bag temperature probe, during
the preheating process.

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•Alarm to indicate that at least one pressure sensor is not connected during any process
in which the pump is operating.
•Overpressure alarm (over 460mmHg), in any of the processes: Preheating, Field
filling, Treatment or Field washing.
oAcoustic 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
- All the clamps will close. Once the pump cover is closed again, the process restarts
where it left off when the cover was opened.

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•Communication error warning
6SYSTEM INSTALLATION
The PRS system is designed for use on a movable stand which is supplied with the
system. If placed on a table or other medical device cart, make sure that the surface of the
table or cart is sufficiently 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 system is to be installed.
NOTEThe system's default power specifications are as follows:
220-240 V ~ 50 Hz or 100-120V~ 50/60 Hz
2.- Connect the system to the mains using the cable supplied.
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.

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4.- If you wish to turn the system off completely, press the MENU key and choose
TURN OFF from the menu. Follow the on-screen instructions for the correct switching
off of the system and, once the screen has gone off, press the off button and the green
light will go off.
7DISPOSABLE 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.
The disposable kit contains a disposable aluminium heat exchanger, the characteristics of
which are as follows:
•Priming volume: 200ml.
•Maximum Pressure: 460mmHg (600mbar)
To learn more about the disposable kit, see the instructions for use of the kit.
Components for the use of the system (pressure transducer, temperature probes, CO2 Chamber
Clamp, CO2Chamber) are included as part of the system.

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8USE AND OPERATION
The software programme follows the following flow diagram, which is explained below:
Access
screen
Preheating
Mounting of
disposable set
Treatment
Field filling
Field washing
Field emptying
Save data
and turn
off

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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 clicking on the box,
the keyboard will appear to enter or modify the data.

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The icons that appear on the screen are to access the following functions:
Programme version
Settings menu
Switching off.

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Next is the main programme, which has a menu on the left-hand side to guide you through the
process. It is suggested to perform the 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 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.

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Press the “Back”button to go back to the previous step.

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8.3 Preheating
The preheating screen provides two options: “Fill Bag” and “Preheating”.
Fill Bag: To start and stop the filling of the bag the "Fill" and "Stop" buttons in the "Fill Bag"
screen must be pressed.
Preheating: To start and stop the preheating process, the "Start" and "Stop" buttons in the
"Preheating" field must be pressed. Whenever this process is underway, the timer will update
on an ongoing basis. Preheating will take place to the set temperature selected by the user
(43ºC by default), changeable between 20ºC and 45ºC.
The temperature of the fluid in the bag can be checked at any time if the corresponding
temperature probe has been connected. If the probe is not connected to the monitoring cable
and the cable to the system, the preheating process will not be possible.
During the whole preheating process, the temperature control software ensures temperature
stability with an accuracy of ±1ºC with respect to the set temperature.

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The temperature graph for the preheating process can be 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 (peristaltic pump, turbine and
clamps).
The treatment will not restart automatically, the user must manually re-activate the
programme.
8.4 Field Filling

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The operating field must be filled with fluid preheated in the previous step, or with fluid at room
temperature. If required, the field can also be emptied to reach the appropriate level of fluid for
the treatment.
To change the working set temperature (43ºC by default) press the "-" and "+" buttons in the
"Temp. Set" box, which can be set between 20ºC and 48ºC. The temperature is controlled via
measurements from the irrigation probe; if this is not connected the corresponding alarm will
appear and the system will not work.
For information purposes, the temperature of the aspiration probe is also shown, although
experiments have shownthat 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 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.
8.5 Treatment
In order to modify the set temperature, follow the same steps described above. In this step,
the default set temperature is 43ºC, although it can still reach 48ºC under the supervision of
the surgeon/anaesthetist. 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.