Reagent Containers Instructions for Use (IFU)
Intended Use
The Reagent Reservoirs are consumables intended for use in an in vitro diagnostic to handle large quantities of backup samples 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
The Reagent Reservoirs are packaged in a sealed film and packed in a cardboard box. They are therefore protected against moisture and transport damage.
- 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.
- 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 Reagent Reservoirs are produced in a Cleanroom (ISO Class 8) and are free of Pyrogens, RNAse, DNAse, PCR Inhibitors, Human DNA, and ATP (except for part numbers 182703 and 187297). With the packaging format described on the left, it is ensured that the Reagent Reservoirs maintain their Purity Grade status during both transport and storage.
Sterility
Hamilton Reagent Containers are not available as a sterilized product.
Shelf Life
Hamilton Reagent Containers have a shelf life of 5 years after the date of production.
The shelf life is indicated on the product packaging label. After removal of the plastic film of the Hamilton Reagent Containers, the shelf life remains unchanged, but the purity of the product can no longer be guaranteed. It is recommended to perform a visual inspection for damage to packaging prior to use and to remove the welded film just before use.
Disposal
The Reagent Reservoirs are intended for single use.
Barcode Definition on the Reagent Reservoir Label
Barcodes are affixed to certain models of reagent Containers and have the format
shown below:
Legal Aspects
Hamilton Company and Hamilton Bonaduz AG are the legal manufacturers of the Hamilton Reagent Reservoirs, 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.
Contact 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 about our other consumable products, such as CO-RE II tips, plates, tubes, sealing consumables, and waste consumables, please visit our website here:
https://www.hamiltoncompany.com/consumables-labware-accessories
Symbols on the Label