Memscap SP 844 Gebrauchsanweisung

Intended purpose: The Physiological pressure transducer and its accessories (dome and monitoring line set) are intended for
measurement of Invasive Blood Pressure.
Instructions for use for SP 844 Transducer and Disposable Dome
Device reference
Medical Device
Device Serial Number
Date of manufacture is found on the label
Indicates the need for the user to consult the
instructions for use.
Memscap AS
Langmyra 11
3185 Skoppum
Norway
Tel: +47 33 08 40 00
IFU status IFU81972 Rev11. 2025.01.28
Clinical Benefits
The clinical benefit of using our invasive blood pressure
monitoring device during surgery or long-term surveillance
is the accurate blood pressure monitoring that also provides
the continuous wave of the pressure to be presented to the
health care professionals on a monitor. During surgery or
long-term surveillance, this information for instance allows
the health care professionals to react to changes in a timely
manner, makes the user able to maintain the patient's blood
pressure at the correct level or to confirm if the blood
pressure is expected to fluctuate rapidly or significantly.
Thus, our device could provide the means to save lives.
Accessories
The Blood Pressure transducer SP844 shall be used with
standard disposable dome with its patented solution against
the transducer. The dome is designed to fit the tubing and to
be integrated into the applicable line set. Since dome in
combination with line set will affect the overall
performance, only accessories by model designation shall be
used.
Dome Model: 844-28, 844-31, 844-33, 844-34
Line Set Model: 844-26
Standards
EU Declaration of conformity contains references to
harmonized standards and CS.
Intended patient population
The transducer and disposable dome are intended for
adults.
www.memscap.com
SP 844 Physiological Pressure Transducer
memscap.com
e-mail: sensors@memscap.com
Contraindications
The device is not intended for use on other patients than
adults.
The device is not intended for transfusion of blood, blood
products or medication.
Precautions and warnings
The device intended user is qualified personnel in
professional healthcare facility environments.
WARNING: Do not re-use or re -sterilize the disposable
dome.
WARNING: Portable RF communications equipment
(including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches)
to any part of the SP844. Otherwise, degradation of the
performance of this equipment could result.
WARNING: A change of cables or connectors may affect
the EMC for the transducer.
DO NOT
• Use cleaning agents containing iodide. Always rinse the
transducer in water after the use of any cleaning agents.
Make sure the transducer is clean and dry before storage.
• Autoclave or use an ultrasonic process on the transducer.
Maximum temperature 70˚C.
• Immerse connector into any kind of liquid.
• Pull cable, either at transducer or connector end.
• Expose the metal diaphragm of the transducer to any hard,
sharp or pointed objects, or to unnecessary forces. When
the transducer is not being used, the protection cap or a
clean and dry dome should always be mounted.
MAKE SURE
• That the dome has not been pressurized before it is
mounted on the transducer.
• That if a syringe is used to flush the dome and the tubing
system, it should be 10 ml or larger.
• That the port to atmosphere is open on the transducer
dome when flushing the dome. Flushing slowly will remove
bubbles more efficiently.
• That warm flush fluid is being used, as warm flush fluid will
decrease the occurrence of spontaneous bubbles.
• That all bubbles have been flushed completely from the
dome and tubing systems before use.
• That the transducer is zeroed and calibrated on the
monitor.
• That the dome is correctly attached to the transducer.
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