Medovate SAFIRA Mode D'emploi page 2

GB
Defini on:
SAFIRA consists of a Sterile Syringe (20ml), Driver and Foot Pedal.
The Sterile Syringe may be manually engaged and disengaged to the gearing of the Driver
unit.
The ba ery operated Driver is ac vated by means of a cable connected Foot Pedal.
Flowrates are limited by design to a maximum of 0.5ml/sec. Approved needle types and
extension tubing may be a ached to the luer fi ng at the end of the SAIFRA syringe. SAFIRA
is to only be used in conjunc on with the single use Sterile Syringe. SAFIRAs internal ba ery
power will perform 200 procedures.
Indica ons for Use:
The Medovate SAFIRA system is intended for use by trained clinicians to administer local
anaesthe cs below a specified pressure threshold to a target nerve bundle for regional
anaesthesia.
Approved Needle Types:
Anaesthesia needles, which fall into the following ranges, have been approved for use with
the SAFIRA system:

The minimum sized needle gauge approved for use with this system is 22G

The maximum length of the needle approved for use with this system is 120mm
Contraindica ons:
SAFIRA is not intended for the following uses:

Intravascular delivery

Delivery of blood, blood products, lipids, fat emulsions or Total Parenteral Nutri on
(TPN)

Infusion of fluids that will enter or contact circulatory blood or cerebrospinal fluid

Delivery of life‐suppor ng medica ons where under– or over‐delivery may cause
serious injury or death

Use with Neonates and Paediatrics
Warnings:
1. Sterile technique should be used at all mes during syringe filling, needle
introduc on and connec on. Asep c technique should be used for removal.
2. Medica ons or fluids must be administered per instruc ons provided by the drug
manufacturer. Physician is responsible for prescribing drug based on each pa ent's
clinical status (such as age, body weight, disease state of pa ent, concomitant
medica ons, etc)
MP‐0007‐0015 ver.4.0
(English)
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