Documentation
Instructions For Use
1.0 Product Description
What is a TrayID Tag?
TrayID tray tags are self-looping identification tags with a detachable adhesive label intended for use in sterile processing workflows to support tray identification and communication.
TrayID tray tags are supplied non-sterile and are intended for use in conjunction with facility sterilization processes. Constructed from a durable polymer-based substrate with a medical-grade adhesive.
2.0 Intended Use
Intended Use
TrayID tray tags are intended for external labeling of surgical instrument trays and wrapped trays to support identification during reprocessing and handling.
TrayID tray tags are not intended for patient contact.
3.0 Contraindications
Contraindications
There are no known contraindications when used as intended.
4.0 Instructions for Use
Step-by-Step Instructions
Step 1
TrayID tags are supplied non-sterile and do not require cleaning or disinfection prior to initial use.
Step 2
Mark the tag using a permanent marker as needed.
Step 3
Secure the tag to the tray handle by threading the tail through the slot and pulling to form a closed loop. No additional fasteners are required for standard use.
Step 4
Process the tray using facility washer/disinfector and drying cycles per facility protocol.
Step 5
After cleaning and drying, remove the tag by unlooping or cutting the tail as needed.
Step 6
Remove the adhesive label from the tag backing.
Step 7
Apply the adhesive label to a clean, dry area of the wrapped tray. Apply firm, even pressure to ensure complete adhesion.
Step 8
If the adhesive label is partially peeled back, removed, or compromised during looping, unlooping, cleaning, or handling, discard the tag and use a new TrayID tag.
⚠ Do not attempt to re-adhere a compromised label. Use a fresh tag.Step 9
Proceed with sterilization per facility protocol.
5.0 Sterilization Compatibility
Sterilization Compatibility
TrayID tray tags have been evaluated for compatibility with standard hospital washer/disinfector and sterilization processes under representative conditions. Performance may vary based on facility-specific equipment, chemistries, packaging configurations, and cycle parameters. The processing facility is responsible for ensuring that cleaning, sterilization, and handling processes achieve the desired result using their specific equipment and protocols.
| Process | Cycle Type | Representative Parameters |
|---|---|---|
| Steam | Gravity | 121°C (250°F), 30 min |
| Steam | Pre-vacuum | 132°C (270°F), 3–4 min |
| Steam | Pre-vacuum | 134°C (273°F), 3 min |
| Low Temp | Hydrogen Peroxide / VHP | Compatible (facility validation required) |
| EO | 100% EO | 735 mg/L, 55°C, 60 min, 50–70% RH |
6.0 Warnings and Precautions
Warnings & Precautions
- For external identification purposes only. Not intended for patient contact.
- Single-use device. Do not reuse, reprocess, or resterilize.
- Do not apply the adhesive label to wet, soiled, or contaminated surfaces.
- Do not apply the label to surfaces that may interfere with sterilization penetration.
- Do not use if product or packaging is damaged.
- Adhesion performance may be affected by excessive moisture, heat, or surface contamination.
- The facility is responsible for validating compatibility with its specific processes.
7.0 – 8.0 Storage & Disposal
Storage & Disposal
Storage
Store at room temperature in a clean, dry environment. Protect from moisture, excessive heat, and direct sunlight.
Shelf life: 1.5 years from date of manufacture.
Disposal
Dispose of used tags and labels in accordance with facility protocol and applicable local regulations.