Merit Medical SAFEGUARD FOCUS Mode D'emploi page 3

6. Bring short strap over shoulder and attach to top of balloon
border ensuring balloon is maintained over desired
compression area.
7. Trim excess strap material.
APPLYING COMPRESSION
8. Engage syringe with valve by inserting and a half twist.
9. Inflate balloon with up to 60ml of air observing compression
of site.
10. Disconnect syringe.
11. Continue to observe site and change air volume as needed
up to a total of 120ml of air.
12. Device can be inflated past the immediate post-operative
period with no more than 30mL, for up to a TOTAL inflation
time of 24 hours.
13. If desired, annotate inflation time and volume on device.
REMOVAL
14. When compression is no longer needed, deflate the balloon
with syringe and carefully remove adhesive from skin or
detach hook and loop bands.
NOTE: If the SafeGuard FOCUS syringe is not available during
air removal or re-injection, the cap on the tubing line may
be removed by twisting and a standard luer syringe can be
attached.
15. Once adhesive is removed from skin do not attempt place
back on patient. If compression is still needed after removal a
new device should be used.
16. Dispose of SafeGuard FOCUS according to hospital protocol.
Caution
Do not use if package is damaged and consult
instruction for use
Catalog number
Batch code
Medical Device
Unique Device Identifier
Single use
Do not resterilize
Consult Instructions for Use
For electronic copy scan QR code, or go to
www.merit.com/ifu and enter IFU ID. For printed
copy, call U.S.A. or EU Customer Service
Sterilized using ethylene oxide
Caution: Federal (USA) law restricts this device to
sale by or on the order of a physician.
Single sterile barrier system with protective
packaging inside
Use by date: YYYY-MM-DD
Date of manufacture: YYYY-MM-DD
Manufacturer
Authorized Representative in European
Community
Keep away from sunlight
Keep dry
Latex Free