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Contraindications:
• Not for use within the central nervous system or central
circulatory system.
Intended user qualification and environment of use:
For use by trained medical professionals in a surgical setting
with appropriate equipment.
Warnings:
• Inspect all sterile packaging prior to use and dispose of device
if sterile barrier is broken or damaged.
• Do not use expired product.
• Do not use the device if damaged.
• Device is for single use only and cannot be reprocessed due to
risks associated with infection and cross contamination.
• Use with care in conjunction with heat sources or lasers to
avoid injury to surgical staff or patient.
• Not for use in conjunction with magnetic therapies (MRI).
Use instructions:
• Inspect all sterile packaging prior to use and dispose of device
if sterile barrier is broken or damaged.
• Inspect label for shelf-life information.
• Remove the device in accordance with sterile practise.
• No assembly of the device is required.
• Inspect device prior to use, damaged devices should be
reported to the manufacturer and not used. Unused damaged
items should be returned to the manufacturer.
• Following completion of the procedure discard the device in
line with hospital guidelines.
Storage and Disposal:
• Store in a dry environment within shelf life as marked. Do not
open until required.
• Dispose of the device as clinical waste and in accordance with
hospital guidelines.
Manufacturer Details:
Contact the manufacturer for technical support. Any serious
incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority.
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