Instructions for Use
Instrument Protection Guards
Solid · Tinted · Gelpi · Radio-Opaque Tip Protection
SurgiSafe™ by SurgiSite
1. Intended Use
SurgiSafe Instrument Protection Guards are designed to protect sharp and delicate instrument tips from damage and to protect personnel from injury during handling and reprocessing. The guards are radio-opaque and made from medical-grade polyvinyl chloride (PVC).
2. Quality Inspection
Ensure Instrument Protection Guards are not torn and are free from visible contaminants before use.
3. Storage
Store in a dry area where cross-contamination can be prevented. Do not store in direct sunlight.
4. Disposal
There are no special disposal instructions for this item beyond facility policy.
5. Known Issues
There are no known product issues or warnings.
6. Sterilization
| Cycle Type | Cycle Temperature | Minimum Cycle Time |
|---|---|---|
| Pre Vacuum | 134°C (273°F) | 3 minutes |
| Pre Vacuum | 132°C (270°F) | 4 minutes |
| Immediate Use Pre Vacuum | 132°C (270°F) | 3 minutes |
| Gravity | 121°C (250°F) | 30 minutes |
7. Additional Information
- Not made with natural rubber latex.
- This is a single-use product.
8. Product Families
- Solid — Opaque vented tip guards.
- Tinted — Translucent vented tip guards.
- Gelpi — Gelpi retractor tip guards.
9. Covered Products
This IFU applies to all SurgiSafe Solid, Tinted, and Gelpi Instrument Protection Guards.
10. Contact
Questions on this IFU or survey documentation: process@surgisite.co · (770) 895-7050. Additional IFUs: SurgiSafe Instructions for Use.
process@surgisite.co · (770) 895-7050
Single Use · Latex-Free · Radio-Opaque