English - Bayer medrad VFlow Mode D'emploi

English

Introduction: Read the information contained in this brochure.
Understanding the information will assist you in using the MEDRAD
VFlow Sterile Hand Controller properly.
Important Safety Notice: The MEDRAD VFlow Sterile Hand
Controller is intended to be used by medical professionals with
adequate training and experience in the operation of the MEDRAD
Mark 7 Arterion Injection System and angiographic procedures and
techniques.
Indications for Use: The MEDRAD VFlow Sterile Hand Controller is
specifically intended for use with the MEDRAD Arterion Injection
System for angiographic studies.
Contraindications: None known.
Restricted Sale: Rx Only.
Report any serious incident that has occurred in relation to this device
to Bayer (radiology.bayer.com/contact) and to your local European
competent authority (or, where applicable, to the appropriate regulatory
authority of the country in which the incident has occurred).
WARNING
Environmental Contamination Hazard - Serious patient or
worker injury or death may result.
• 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.
• For devices labelled 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.
CAUTION
Environmental Contamination Hazard - Minor or moderate
patient and/ or worker injury may result.
• Properly discard disposables after use, in accordance with
hospital hazard waste disposal procedures. Do not reuse
disposables.
NOTICE
Electro-Mechanical Hazard - Equipment Damage may result.
• Do not use tools to over tighten connections or to assist in the
removal of disposables.
NOTE: Refer to the MEDRAD Mark 7 Arterion injector operation
manual for a full set of instructions, warnings and precautions.
The MEDRAD VFlow Hand Controller is a sterile device intended for
single patient use. The Hand Controller works for Fixed Flow Rate and
Variable Flow Rate injections. When in the Variable Flow Rate injection
mode, the flow rate increases incrementally as the Hand Controller
plunger (A) is depressed, and decreases as the Hand Controller
plunger is released. In the Fixed Flow Rate injection mode, the Hand
®
Controller acts as a start switch, and release of the device stops the
injection.
The Hand Controller button (B) is non-functional and will beep from the
Injector head and Display Control Unit when depressed.
A
B
Hand Controller
Hand Controller Installation
1. Ensure that the injector is in the disarmed state.
2. Open the hand controller pouch using sterile technique.
3. Using sterile technique, remove the hand controller from the
pouch.
4. Plug the hand controller into the underside of the Injector Head
(see drawing below). Listen for an audible "click" to confirm proper
connection.
NOTE: If the hand controller is damaged or does not work properly,
discontinue use and discard.
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