Fresenius Medical Care DALI 500 Mode D'emploi page 7

DALI 500 / 750 ADSORBER
Termination
Refer to the IFU of the active device for the termination of the treatment and also to the
Disposal section of the present IFU.
WARNINGS AND PRECAUTIONS
Technical warnings and precautions
−
Use aseptic handling methods. Improper handling of the connection sites can lead to
contamination, and pathogens can enter the extracorporeal blood circuit.
−
Blood and plasma may be contaminated with pathogenic agents of transmittable
diseases. After having contact with the patient's blood or plasma, the adsorbers are
considered to be potentially infectious. For proper disposal, please refer to the Disposal
section of the present IFU.
−
DALI 500 / 750 Adsorbers are intended for single use only. Re-use may be hazardous to
both the patient and operator. Cleansing solutions and disinfectants should not come into
contact with the product as they may damage materials employed for the housing and
thus impair the product's safety and performance. DALI 500 / 750 Adsorbers are not
intended for resterilization. If the products are resterilized, biological contamination may
not be prevented completely. In addition, resterilisation may cause malfunctions.
Limitations of the medical device
The adsorbers used in the DALI system possess a limited adsorption capacity. In individual
cases, efficiency may be limited in patients with an extremely high level of LDL cholesterol
(e.g. patients suffering from a homozygous familial hypercholesteraemia) or Lp(a) before
apheresis. In these cases, it is possible to use a larger configuration, having a higher capacity,
e.g. DALI 1000 or DALI 1250.
Particular notes on materials and substances
For SVHC information according to Article 33 of Regulation (EC) No.
1907/2006 ("REACH") please use this page:
www.freseniusmedicalcare.com/en/svhc
SPECIAL PRECAUTIONS FOR STORAGE
Do not store below +5°C or above +25°C.
Keep away from sunlight.
Fragile, handle with care.
The shelf life is three years (see also use-by date on the product label).
DISPOSAL
Ensure safe disposal of any unused product or waste material in accordance with local
regulations. Materials that have been in contact with blood or other material of human origin
may be infectious. Dispose of such materials by taking the necessary precautionary measures
and in accordance with local regulations for (potentially) infectious materials.
Contains synthetic polymer microparticles. Avoid release of the adsorber content into the
environment; do not open or destroy the housing even after use.
SYMBOLS USED ON LABELS
Sterile fluid path
Sterilized using steam
Sterile barrier system with
protective packaging outside
Batch code
Medical Device
Use-by date
Date of manufacture
Keep away from sunlight
Caution
Do not use if the product sterile barrier system or its packaging is compromised
The CE marking documents compliance with the applicable requirements set out by the
European medical device regulations and other applicable EU legislation providing for its
affixing.
Notified body with regards to
TÜV SÜD Product Service GmbH (0123)
DATE OF REVISION OF TEXT
07/2023
Temperature limit
Catalog number
Do not reuse
Unique Device Identifier
Manufacturer
Consult Instructions for Use
Patient information website
Fragile, handle with care
the European medical device
A digital version of this document is available on the following website:
www.freseniusmedicalcare.com/en/product-information
INFORMATION ON THE MANUFACTURER
Legal manufacturer
Fresenius Medical Care AG
Else-Krӧner-Str. 1, 61352 Bad Homburg, GERMANY
+49 6172 609-0
regulation:
en
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