Installation - Stryker Performance-LOAD Operation Manual

I I n n s s t t a a l l l l a a t t i i o o n n
Q Q u u a a l l i i t t y y s s y y s s t t e e m m r r e e g g u u l l a a t t i i o o n n
The U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 provides guidance regarding the
installation of devices, such as the cot fastener system. To comply with these federal regulations, each device must be
verified to have been properly installed by trained* individuals by following the inspection criteria in the installation checklist.
This document must be maintained for a minimum of seven years for each serial number/installation.
*The installation facility must maintain their own training records showing that the installer was qualified.
C C F F R R 2 2 1 1 S S E E C C . . 8 8 2 2 0 0 . . 1 1 7 7 0 0 i i n n s s t t a a l l l l a a t t i i o o n n
(a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection
instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring
proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the
instructions and procedures with the device or otherwise make them available to the persons installing the device.
(b) The person installing the device shall make sure that the installation, inspection, and any required testing are performed
in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results
to demonstrate proper installation.
C C F F R R 2 2 1 1 S S E E C C . . 8 8 2 2 0 0 . . 1 1 8 8 0 0 g g e e n n e e r r a a l l r r e e q q u u i i r r e e m m e e n n t t s s
W W A A R R N N I I N N G G
• Always install the cot fastener system as described in this manual. Improper installation can result in injury. Make sure
that, at a minimum, your configuration is tested to meet the National Truck Equipment Association/Ambulance
Manufacturer's Division Standard 004, Litter Retention System Static Test (AMD-004).
• Take special precautions regarding electromagnetic compatibility (EMC) when you use medical electrical equipment.
Install and place the cot fastener system into service according to the EMC information in this manual. Portable and
mobile RF communications equipment can affect the function of the cot fastener system.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably
accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such
records, including those not stored at the inspected establishment, shall be made readily available for review and copying
by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those
records stored in automated data processing systems shall be backed up.
(a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether
information may be disclosed under the public information regulation in part 20 of this chapter.
(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design
and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the
manufacturer.
EN 10 6392-009-001 Rev D.3