IMI 60483 R2 Prep Lock Tamper Evident Cap Instruction Manual
- June 15, 2024
- IMI
Table of Contents
60483 R2 Prep Lock Tamper Evident Cap
Instructions for Use
Prep-LockTM
Tamper Evident Cap for IV Syringes
This bulk bag package configuration accommodates syringe fill automation.
Indications for use
Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
Operating Instructions
Use Aseptic Technique through all steps
-
Open bag by pulling apart tabs from corner.
-
Insert IV syringe’s male luer into the cap and rotate clockwise while pushing downwards.
Verify the installation by rotating the cap until snug. -
To Remove the Tamper Evident Cap, grip the Tamper Evident Cap and pull the outer sleeve straight off.
-
Twist off the tip cap counter clockwise and remove the small ring.
Damaged components or missing cap indicates potential tampering.
Contraindications
None when used as described in the device’s Instructions for Use.
Caution
- Over or under torque can result in leaks and or difficulty in removal. It is the responsibility of the user to verify and validate their processes to maintain product integrity and sterility
- Do not use if sterile barrier is broken
| **** | Manufacturer |
|---|---|
| Do not use if package is damaged | |
| **** | Batch code |
| **** | Catalogue number |
| Sterilized using ethylene oxide | |
| Use-by-date | |
| Do not re-use | |
| Do not resterilize | |
| **** | Consult instructions for use |
| For sale by or on the order of a licensed health care practitioner | |
| **** | Authorized representative in the European Community |
| **** | Caution |
| Non-pyrogenic |
IMI-401-Spec.A-242 60483 R2 Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
MADE IN THE USA
This product may be covered on one or more of the following U.S.
Patents: U.S. 6,585,691, U.S. 6,921,383, U.S.
7,762,988 & U.S. 8,591,462
International Medical Industries, Inc.
2981Gateway Dr., Pompano Beach, FL 33069 USA
www.imiweb.com
954-917-9570