Product Lifetime - GCE druva MEDIUNIT Instructions For Use Manual

10. PRODUCT LIFETIME

10.1. BATCH NUMBER AND PRODUCTION DATE
Number perforated on the housing and quick-coupler is combination of
the following data:
XXXXXXX: batch number
YY/MM: date code
EN
Ex.: Number 7366506 indicates a component with batch number 7366506.
Ex. Number 13/04 indicates a component with manufacturing date - April,
year 2013.
10.1.1. PRODUCT LIFETIME AND WASTE MANAGEMENT
Lifetime of TU, excluding parts permanently connected to the pipeline, is
10 years. The housing part of TU, if the regular maintenance is observed
- see chapter 9, has identical length of lifetime as the hospital pipeline. At
the end of the product's life time, the product must be withdrawn from ser-
vice. The owner of the device shall prevent the reuse of the product and
handle the product in compliance with "Directive of European Parliament
and Council 2006/12/ES of 5th April 2006 on waste".
In accordance to Article 33 of REACH GCE, s.r.o. as responsible manu-
facturer shall inform all customers if materials containing 0.1% or more of
substances included in the list of Substance of Very High Concern (SVHC).
The most commonly used brass alloys used for bodies and other brass
components contain 2-3% of lead (Pb), EC no. 231-468-6, CAS no. 7439-
92-1. The lead will not be released to the gas or surrounding environment
during normal use. After end of life the product shall be scrapped by an
authorized metal recycler to ensure efficient material handling with mini-
mal impact to environment and health.
To date we have no information that indicates that other materials con-
taining SVHC of concentrations exceeding 0.1% are included in any GCE
product.
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