BIOSURGICAL COMBAT MEDICAL PRS+, Руководство пользователя

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USER MANUAL
BSLAB07_v18_ EN
Biosurgical S.L., part of Combat Medical Group
Page 3 of 39
1 INTRODUCTION
The COMBAT PRS
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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.
2 PURPOSE 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.
3 USER QUALIFICATIONS
The system should be used by qualified healthcare professionals:
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Doctors
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Nurses
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Perfusionists
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Other appropriately trained healthcare professionals
4 WARNINGS AND PRECAUTIONS
4.1 Warnings
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Once the system has been configured prior to treatment, no additional electrical
maintenance is necessary during the functioning process thereof.
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Danger of electric shock. Do not open the system.
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To avoid the risk of electric shock, this system should only be connected to a power
supply grid with grounding protection.
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The system has an equipotential grounding conductor connected to the mains
grounding of the building.