Medrad Mark 7 Arterion, Operation Manual

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4 System Warnings, Precautions, and Notices
4.1 Warnings
Air Embolism Hazard - Serious patient injury or death may result.
• Do not inject air.
• Purge all air from syringe and disposables before connecting or injecting to patient.
• Use only accessories and options provided by Bayer which are designed specifically for
the injection system.
• Inspect system and do not use when signs of damage are evident.
• Verify that the FluiDots indicators are rounded to ensure that fluid is present in the
syringe.
• No modification of equipment is allowed.
Serious patient and/or worker injury or death may result.
• Use of non-Bayer supplied disposables, including administration sets and additions to
administration sets, such as but not limited to bleed back control devices and pressure
transducers may cause patient injury if not properly connected or flushed. These devices
must be compatible with your system. Refer to manufacturer's instructions for proper use
of these devices.
Do not use if sterile package is opened or damaged.
• Patient or operator injury may result if package is opened or damaged, or if damaged
components are used. Visually inspect contents and package before each use.
Cross contamination hazard - Serious patient and/or worker injury or death may result.
• Ensure only syringes from Bayer are used on the system.
• Do not store filled syringes for later use.
• Discard previously filled unused syringes.
• Do not reuse disposables.
• For devices labeled for single use, please note: This product is intended for single
use only. Do not resterilize, reprocess or reuse. The disposable devices have been
designed and validated for single use only.
Re-use of the single use disposable
devices pose risks of device failure and risks to the patient. Potential device failure
includes significant component deterioration with extended use, component malfunction,
and system failure. Potential risks to the patient include injury due to device malfunction
or infection as the device has not been validated to be cleaned or re-sterilized.
Procedure Delay Hazard - Serious patient and/or worker injury or death may result.
• Turn off any equipment that could generate an electrostatic discharge during procedure.
Electric Shock Hazard - Serious patient and/ or worker injury or death may result.
• The system should be opened and serviced by Bayer HealthCare Services or Bayer trained
service personnel.
• Use only power cord approved for use on Mark 7 Arterion .
• For U.S. installations, equipment shall only be connected to Hospital Grade or Hospital
Only outlets.
• Disconnect the system from line power before cleaning or attempting to perform any
maintenance or repairs.
• Avoid contact with pins.
• Ensure that connector covers are in place or cables are connected.
• Do not allow injector head to contact patient.
• Equipment must only be connected to supply mains with protective earth.
• Unplug system prior to servicing.