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College Park celsus iVT Instructies pagina 6

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WARRANTY INSPECTION /MAINTENANCE INFORMATION
EN
College Park recommends that you schedule your patients for check-ups per the warranty inspection schedule below.
High patient weight or activity level may require more frequent inspections. We recommend you visually inspect
the following applicable parts for excessive wear and fatigue at each warranty inspection.
▪ Composites and Adapters
▪ CPI Sock
▪ Foot Shell
WARRANTY INSPECTION SCHEDULE FOR THE CELSUS IVT: SIX MONTHS, THEN ANNUALLY.
TECHNICAL ASSISTANCE / EMERGENCY SERVICE 24-7-365
College Park's regular office hours are Monday through Friday, 8:30 am – 5:30 pm (EST). After hours, an
emergency Technical Service number is available to contact a College Park representative
LIABILITY
The manufacturer is not liable for damage caused by component combinations that were not authorized by the
manufacturer.
CAUTION
College Park products and components are designed and tested according to the applicable official standards
or an in-house defined standard when no official standard applies. Compatibility and compliance with these
standards are achieved only when College Park products are used with other recommended College Park
components. This product has been designed and tested based on single patient usage. This device should NOT
be used by multiple patients.
CAUTION
If any problems occur with the use of this product, immediately contact your medical professional. The
prosthetist and/or patient should report any serious incident* that has occurred in relation to the device to
College Park Industries, Inc. and the competent authority of the Member State in which the prosthetist and/or
patient is established.
*'Serious incident' is defined as any incident that directly or indirectly led, may have led, or might lead to any
of the following; (a) the death of a patient, user, or other person, (b) the temporary or permanent serious
deterioration of a patient's, user's, or other person's state of health, (c) a serious public health threat.
COMPLIANCE
This device has been tested according to ISO 10328 standard to two million load cycles.
Depending on patient activity this may correspond to 2-3 years of use.
ISO 10328 - LABEL
FOOT SIZE
21-24 cm
25-30 cm
ISO 10328 - "P" - "m"kg*)
*) Body mass limit not to be exceeded!
For specific conditions and limitations of use, see intended use
section of manufacturer's written instructions.
▪ Air Bladder
▪ Hose Connector
▪ Exhaust Vent
WEIGHT LIMIT (KG) LABEL TEXT
100
136
ISO 10328-P5-100 kg
ISO 10328-P6-136 kg
▪ Check Valves
▪ Tube
▪ Return Spring Assemblies

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