Important Safety Information; Transport And Storage - MIETHKE proGAV 2.0 Mode D'emploi

EN | INSTRUCTIONS FOR USE
3.01.04 REPEATED USE AND RE-
STERILISATION
The proGAV Checkmate must be sterilised in
double sterile packaging in an autoclave (steam
sterilisation, fractionated vacuum method) at
134 °C and 5 minutes retention time.
3.01.05 OPERATING CONDITIONS
proGAV 2.0 Tools are to be used at room tem-
perature in healthcare facilities, such as hospi-
tals, doctor's surgeries and rehabilitation facili-
ties.
3.01.06 PRODUCT LIFE
These medical devices are designed to oper-
ate accurately and reliably over long periods
of time. The expected product life of the pro-
GAV 2.0 Tools is three years after first use, pro-
vided that the product is exposed to normal
usage conditions and is properly maintained
(see chapter "3.04 Use of the product").
The tools may be used beyond this time if they
are in perfect working condition. However, no
guarantee can be assumed that these medical
devices will not require replacement for medical
or technical reasons.
3.01.07 PRODUCT CONFORMITY
The product meets current regulatory require-
ments.
Translations of these instructions for use into
additional languages can be found on our web-
site:
(https://www.miethke.com/downloads).

3.02 IMPORTANT SAFETY INFORMATION

3.02.01 SAFETY INSTRUCTIONS
Important! Read all safety instructions care-
fully before using the product. Follow the safety
instructions in order to avoid injuries and life-
threatening situations.
WARNING
If the sterile packaging of the Checkmate is
damaged, the product must not be used.
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WARNING
The Checkmate must not be used after the
expiry date and must be re-sterilised as
described under chapter 3.01.04.
Due to the risk of injury resulting from incor-
rect use of the product, the instructions for
use must be read carefully and understood
before the product is used for the first time.
Prior to use, it is essential to check that the
proGAV 2.0 Tools are complete and intact.
3.02.02 COMPLICATIONS, SIDE EFFECTS
AND RESIDUAL RISKS
Various side effects and complications can
occur when using proGAV 2.0 Tools:
Allergic reaction / intolerance to the mate-
rials of the instruments
Immediately consult a physician if the patient
suffers from skin rashes and tightness, severe
headaches, dizzy spells or the like.
3.02.03 REPORTING OBLIGATION
Report all serious incidents (damage, injuries,
infections, etc.) that occur relating to the prod-
uct to the manufacturer and the responsible
state authority.
3.02.04 PATIENT INFORMATION
The attending physician is responsible for
informing the patient and/or his/her proxy in
advance. The patient is to be informed about
warnings, precautions, contraindications, pre-
cautionary measures to be taken as well as
restrictions on use in relation to the product.

3.03 TRANSPORT AND STORAGE

The medical devices must always be trans-
ported and stored in a clean and dry place.
Storage conditions
Temperature range
for storage
proGAV ® 2.0 Tools
0 °C to +40 °C