ATS Pulmonary Function Laboratory Manual

chapter  5

Instrument Maintenance 1.

Preventative maintenance (PM): refers to maintenance performed on a scheduled basis that is usually done by the laboratory staff. The goal of PM should be to anticipate problems before they occur and cause the instrument to malfunction. Examples of PM include: 1.1. Checking volume-displacement spirometers for leaks and linearity 1.2. Cleaning or replacing the flow sensor 1.3. Checking tubing for tears 1.4. Electrical safety. 2. Corrective maintenance (i.e., repairs) is unscheduled action required to correct instrument failure. This is usually done by the manufacturer’s representative or by the hospital bioengineer, but can and sometimes is performed by the laboratory staff. 3. PM should be done on a daily, weekly, monthly, or yearly schedule depending on the instrument and the recommendations that are being followed. 4. Maintenance logs should be established and used to indicate which instruments need PM and when, and to record the dates and types of PM procedures performed. If PM identifies a problem and corrective action is taken, the action should be recorded. 5. New instrumentation: Whenever new instruments are purchased and set up, they must undergo verification and validation prior to reporting test results.

Installation Manual 1. The development of an installation manual for new equipment is recommended. 2. The installation manual should be kept for the life of the instrument (2). 3. Essential components 3.1. Vendor/purchaser contract 3.1.1. Equipment model and serial number 3.1.2. Purchase date and cost 3.1.3. Warranty information and/or service contracts 3.1.4. Manufacturer’s instrument specifications 3.2. Equipment installation records 3.2.1. Equipment validation performed by the manufacturer 3.2.2. Equipment cleaning instructions 3.2.3. Software version installed, including any updates 3.2.4. Support services and training information 3.3. Installation calibration data obtained by the manufacturer’s representative 3.3.1.

Results of data generated from a known-volume syringe while in the subject test mode

3.3.2.

Results of data on biologic standard(s)

3.4.

Calibration data obtained by user

3.5. Results of tests on at least 40 healthy individuals for equipment validation and verification of pre- dicted values may be helpful.

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