CO-RE Tips – Instructions for Use (IFU)
Intended Use
The CO-RE and CO-RE II Tips are consumables intended for use in an in vitro diagnostic environment to pipette liquid samples and reagents for biological and chemical tests using Hamilton automated liquid-handling instruments.
You can download the Instructions for Use (IFU) in multiple languages above. Additional languages are available upon request.
Transport and Storage
Hamilton CO-RE Tips have different packaging formats:
Frame: The sealed blister containing the tips and racks is packed in a bag and a cardboard box.
Nested: The nested tip racks with tips are sealed in a film and packed in a cardboard box.
Tip Box: The tip boxes are sealed in a film and packed in a cardboard box.
- Transport: The product must be transported at temperatures between -15 °C (+5 °F) and +55 °C (+131 °F) up to a maximum of 90 days. This is indicated on the secondary label (cardboard box).
- Storage: The product must be stored at temperatures between 0 °C (+32 °F) to +35 °C (+95 °F) until expiration. This is indicated on the primary label (blister = frame format only).
- Short-term temperature peaks: Up to +55 °C (+131 °F) for a maximum of 90 days and storage up to +45 °C (+113 °F) for up to one year at any point during the product shelf-life period are validated and do not affect product integrity.
- Relative Humidity: Not required.
Purity Grade
The CO-RE and CO-RE II Tips are produced in a Cleanroom (ISO Class 8) and are free of Pyrogens, RNAse, DNAse, PCR Inhibitors, Human DNA, and ATP. With the packaging format described on the left, it is ensured that the Hamilton CO-RE and CO-RE II Tips maintain their Purity Grade status during both transport and storage. Hamilton CO-RE and CO-RE II Tips are available as both sterile and non-sterile products.
Sterility
The sterile products are sterilized in accordance with ISO 11137. Sterilized CO-RE and CO-RE II Tips are marked with “STERILE R” on the blister lid, sealed film, and box label. On the box is a sterilize indicator which turns red after the sterilization.
Shelf Life
The shelf life of non-sterile tips is 5 years and sterile tips 3 years, after the date of production. The shelf life is indicated on the rack and box label. After removal of the sealed blister lid (frame format) or the sealed film (NTR and tip box format) is torn open, or if the blister, lid or sealed film is damaged, the shelf life remains unchanged, but the purity and sterile conditions (for sterile tips) of the product can no longer be guaranteed. It is recommended to perform a visual inspection of the packaging for damage before use and to remove the blister lid or sealed film just before use.
Barcode Definition on Rack Label
The tip type must be checked via barcode during the loading step. Using the correct tip type must be ensured.
Legal Aspects
Hamilton Company and Hamilton Bonaduz AG are the Legal Manufacturers of the CO-RE and CO-RE II Tips,
all rights reserved.
This Instructions for Use (IFU) document may not be used or reproduced in any way whatsoever without the express written consent of Hamilton Company or Hamilton Bonaduz AG.
Note
Any serious incident or near-incident that has occurred in relation to the consumables shall be reported to Hamilton and to the competent authority of the Member State in which the operator is established.
Contacting Hamilton either by contacting a local Hamilton representative or by utilizing Hamilton’s webpage, which can be found on the footer of this document.
If you have questions on our other consumable products, such as: reservoirs, plates, tubes, sealing consumables, and waste consumables, please visit our website under this link:
https://www.hamiltoncompany.com/consumables-labware-accessories
Symbols on the Label
