College Park ORBIT Technische Anleitung Seite 5

WARNINGS
WARNING
▪ Do not expose this product to corrosive materials, salt water or pH extremes.
▪ Any further disassembly or modification of components will void the warranty.
Failure to follow these technical instructions or use of this product outside the scope of its Limited
Warranty may result in injury to the patient or damage to the product.
RESIDUAL RISK STATEMENT
NOTICE OF RESIDUAL RISK
During fitting process, ensure that CPI sock does not become pinched between foot and
endoskeletal componentry.
WARRANTY INSPECTION /
MAINTENANCE INFORMATION
College Park recommends that you schedule your patients for check-ups according to the
warranty Inspection schedule below.
High patient weight and/or impact level may require more frequent inspections. Soft component wear
depends on the patient weight, impact level and environment. We recommend you inspect the following
applicable parts for excessive wear and fatigue at each warranty inspection and replace as needed.
▪ Composites and Adapters
▪ CPI Sock
WARRANTY INSPECTION SCHEDULE FOR THE ORBIT: 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.
▪ Foot Shell
▪ Heel Wedge (if applied)
EN