Merit Medical MERITRANS Instrucciones De Uso página 2

TRANSDUCER INTERFACE CABLE
INSTRUCTIONS FOR USE
IMPORTANT: THE MERIT INTERFACE CABLE IS REUSABLE. The device is
supplied non-sterile.
INTENDED USE
This transducer interface cable is intended to connect a Meritrans® Pressure
Transducer to a compatible pressure monitor.
CLINICAL BENEFITS
To facilitate pressure monitoring of a patient.
USER / PATIENT / CLINICAL
USER: Qualified nurses, clinicians and physicians
PATIENT: Pediatric and adult applications
CLINICAL: Hospitals or appropriate clinical environments
CAUTIONS
Visually inspect the cable before each use. If the cable is broken, cracked,
frayed, or otherwise damaged, do not use the cable. If any of the cable
connector pins are bent or damaged, do not use the cable.
Never immerse the electrical connectors in liquid. Doing so can damage the
connector wiring. If the socket connection to the transducer becomes wet, dry
thoroughly by hanging the socket end down. Never use if socket is wet. This
may cause corrosion, and erratic readings during use.
Do not steam-autoclave the interface cable, moisture can damage connector
wiring.
Do not radiate or EO sterilize the cable.
Grasp the connector, not the cable itself, when connecting or disconnecting
the cable from the transducer and/or monitor.
Note: Care must be taken to align the pins and sockets correctly prior to
connection in order to prevent undue stress on the pins or sockets. Not doing
so may lead to a poor connection.
The device is non-sterile and reusable. Discontinue use if it shows signs of
material degradation, breaking, cracking, pin corrosion or other physical signs
of deterioration.
To Clean
Clean and disinfect the device per standard hospital protocol. Use aseptic
technique when handling the device and hospital approved cleaning agent to
remove blood and debris from the cable.
STORAGE CONDITIONS
Store in cool dry place away from direct sunlight.
The reusable product shall be discarded upon damage. Dispose of device in
a manner consistent with standard protocols for waste disposal of electronic
equipment.
In the EU, any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of the
applicable Member State.
English
SYMBOL
Consult Instructions for Use.
Non-Sterile
Caution
Catalog Number
Medical Device
Unique Device Identifier
Manufacturer
Date of Manufacture
Serial Number
Separate Collection for EEE (Electrical and Electronic Equipment)
Keep Dry
Authorized Representative in the European Community
MR Conditional
Non-clinical testing has demonstrated the Meritrans device is MR
Conditional. A patient with this device can be safely scanned in an MR
system under the following conditions:
• Static magnetic field of 3-Tesla or less
• Maximum spatial gradient magnetic field of 4,000 Gauss/cm(40 T/m)
• The cable and the transducer must not contact the patient during operation
of the MR system
• The cable and the transducer must not be placed inside the bore of the MR
system during operation of the scanner
• The cable is permitted in the MR system room, but must not be operational
or connected to a monitoring system during the MRI procedure
DESIGNATION