Ovizio Imaging Systems ILine F Pro, User Manual

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Monitoring Duration From 4 to 30 days
Total process volume From 0.3 to 10.0L total process volume
1
Typical hold-up volume From 0.001 to 0.05 L
Liquid hold-up duration < 5min
Typical flow rate From 4 to 12 mL/min
Shelf-life
6 months at storage temperature from 15 to 30 °C
Recipient Interface
To ensure a safe and sterile connection, the device features a PVC tubing (3,1x4,2mm IDxOD) for both inlet and
outlet connection. The tubing is suitable for cut welding with most of standard welding equipment.
Sterilization
All devices are sterilized by gamma irradiation (25 kGy) and individually packaged
Packaging
Double PE bag with Tyvek fast-opening. No tool required
Regulatory Compliance
All fluid-contact materials have passed the current USP Biological Test or ISO 10993 certification.
Quality Control
Each device is individually assigned a serial number, integrity tested and certified. CoC is provided at shipping.
Other documentation available upon request
It complies with cGMP requirements for single-use device manufacturing.
Disclaimer
The BioConnect shall not be used in any clinical procedures or for diagnostic purposes unless Ovizio approved
Specifications subject to change without notice.
1
Total volume required for efficient pumping and monitoring