4.1.2 Medical device products should be installed in strict accordance with the product instruction manual installation requirements for installation, sterile medical devices are installed in sterile conditions to ensure that the product use special performance.
4.1.3 Medical device product installation requirements
4.1.3.1 Carefully check the information, random accessories, after confirmation to open the package for installation.
4.1.3.2 Parts should be checked before installation of the whole machine, parts, to confirm the integrity before installation.
4.1.3.3 The installation of the product should follow the principle of "from the inside out, from top to bottom" to ensure that the parts and components, the performance and function of the machine.
4.1.3.4 After the installation of the whole machine and parts of the combined parts should be checked one by one to ensure that the installation of the correct qualified.
4.1.3.5 The complete installation of the machine for the trial test, the test is qualified for clinical use.
4.1.4 product installation found in the machine, parts damage to fill in the record, the machine, parts all into a plastic bag sealing, packaging, and then reported to the administrator according to non-conforming products, quality manager in collaboration with the product acceptance officer to confirm the existence of product quality problems, the installation of personnel returned to the warehouse, the warehouse to notify the procurement of personnel to contact with the supplier of the return of goods
4.1.3.5 to the complete installation of machine and components combined to ensure that the trial test test passed before being used in the clinic.