Miltenyi Biotec TheraSorb TS TPE Instrucciones De Uso página 2

Instructions for use – read carefully
Contents of the packaging
1 TheraSorb - TS TPE tubing set
Intended purpose/Areas of application
The product connects the different components of the TheraSorb LIFE 21 therapeutic apheresis platform (e.g., solutions) and the patient
for a treatment using the LIFE 21 apheresis unit. It also provides the needed fluid paths for whole blood, plasma and solutions. The
integrated disk separator separates the patient's whole blood into plasma and cellular components.
The product is an accessory to the LIFE 21 apheresis unit and must only be used in conjunction with the TheraSorb product line.
Contra-indications, side-effects, interactions, indications, patient target groups, and intended users
For information about contra-indications, side-effects, interactions, indications, patient target groups, and intended user read the user
manual for the TPE treatment module on the LIFE 21.
Any serious incident that has occurred in relation to this product should be reported to Miltenyi Biotec B.V. & Co. KG – using the contact
information provided – and the competent authority of the member state in which the user of this product is established and in which
the patient has been treated.
Warnings and Precautions
Caution. Aseptic working procedure must be applied for use of the product.
Make sure that all Luer Lock connections are closed tightly.
All materials which have come into contact with blood or plasma must be treated as infectious material. Regulations
for the treatment of infectious materials must be observed.
Do not use after the use-by date indicated on the label.
Fragile, handle with care.
Do not use if package is damaged. Use product only if sterile package is undamaged and sealed. Do not use if the tip
protectors are not in place.
Do not re-use. The product is a single-use device. Any re-use constitutes an intentional off-label use and a subsequent
hazard for a patient. A re-use of the medical device can cause infection of a patient due to microbial (cross)
contamination.
Do not resterilize. The product is not designed to withstand cleaning, disinfection and sterilization after use. It is not
designed to maintain integrity and sterility of the interior fluid path after use (mechanical stress, material fatigue) and
an ingress of microorganisms can not be excluded.
Storage
Store the product at +15 °C to +30 °C (+59 °F to +86 °F) until usage.
Further information
Single sterile barrier
system with protective
packaging outside
The symbol indicates the product as spare part
TheraSorb - DS 100 (REF 330-000-625), replaces the integrated disk separator in case of malfunction.
Glossary of symbols
Medical device
Catalogue number
Instructions for use
Consult instructions for use.
Follow the instructions provided by appropriate user manuals of the LIFE apheresis unit and software screens.
Warranty
The TheraSorb LIFE 21 therapeutic apheresis platform must only be used by appropriately qualified and trained medical personnel. The
manufacturer accepts no responsibility for damages, which may arise from attempts, on the part of the user, to change or modify the
product.
Non-pyrogenic
Batch code
Unique Device Identifier
English | en
Sterilized using ethylene
oxide
Manufacturer
Date of manufacture