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Warnings: (con nued)
3.
Make sure the medica on being infused is approved for Regional Anaesthesia / PNB's
(e.g. Lidocaine); follow all labelling instruc ons for medica on use.
4.
SAFIRA is MRI unsafe
5.
Opening injec on pressure varies among different ssues, being the highest when
the needle p is lodged in low compliance ssue (e.g., roots of brachial plexus,
tendon) and lowest when injected in the so connec ve ssues (e.g., adipose ssues,
perineural space). SAFIRA limits the injec on pressure to less than 20psi.
6.
The SAFIRA Syringe is designed for single use in one pa ent and must not be re‐
sterilised, recondi oned or re‐used. Re‐use of the SAFIRA Syringe risks infec on (due
to accumula on of pathogens in the device that are subsequently injected) or
poten ally hazardous drug effects (due to residual drug compounds contamina ng
the intended drug and then being injected).
7.
No modifica on of this equipment is allowed
Precau ons:
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN
1.
SAFIRA has no user serviceable parts. Do not a empt to repair or alter the device.
2.
The Sterile Syringe component is disposable and must be discarded a er use in
accordance with hospital, administra ve and /or local government policy.
3.
Do not use the Sterile Syringe if the packaging is open or damaged or if the sterile
barrier is compromised.
4.
The Sterile Syringe component is single use only.
5.
The Driver component is a limited re‐use device.
6.
Flow rates may vary due to fill volume, viscosity and/or drug concentra on,
posi oning the driver above or below the injec on site, and temperature.
7.
Start delivery within 8 hours of filling the Sterile Syringe. Storage of a filled Sterile
Syringe component for more than 8 hours may result in slower flow rates.
8.
SAFIRA is not made with natural rubber latex
9.
SAFIRA is only to be operated by a trained Health Care Professional.
10.
The Sterile Syringe is not intended for measurement use.
MP‐0007‐0015 ver.4.0
GB
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