User's Manual

18 6390-009-001 REV B www.stryker.com
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QUALITY SYSTEM REGULATION
The U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 provides guidance regarding
the installation of devices, such as Power-LOAD. 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 “Power-LOAD
Installation Checklist” on page 38. This document must be maintained for a minimum of 7 years for each serial
number/installation.
*the Power-LOAD installation facility must maintain their own training records showing that the installer was qualified.
CFR 21 SEC. 820.170 INSTALLATION
(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 person(s) installing the device.
(b) The person installing the device shall ensure 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.
CFR 21 SEC. 820.180 GENERAL REQUIREMENTS
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.
WARNING
• Improper installation can result in injury. Install the Stryker Model 6390 Power-LOAD system as described in this
manual. Ensure that, at a minimum, your configuration with Power-LOAD is tested to meet AMD Standard 004.
• Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment
like Power-LOAD. Install and place Power-LOAD into service according to the EMC information in this manual.
Portable and mobile RF communications equipment can affect the function of Power-LOAD.
Quality System Regulation for Installation