ANSI Z80.38 pdf free download
ANSI Z80.38 pdf free download.Ophthalmics – Light Hazard from Operation Microscopes Used in Ocular Surgery.
4 Requirements for optical radiation hazard
4.1 General
Operation microscopes shall comply with the light hazard protection requirements given in ANSI Z80.36.
4.2 Determination of classification group
The operation microscopes shall be classified as Group 1 or Group 2 instruments as defined in clause 4 in
ANSI Z80.36. The test methods given in clause 5 in ISO 10936-1 shall be used to make this determination.
4.3 Requirements for Group 1 instruments
4.3.1 General
The operation microscope shall be tested in accordance with 5.2 in ANSI Z80.36 to determine if it is a Group 1 instrument. If the operation microscope does not fulfill the requirements of 5.2 in ANSI Z80.36 for any limits therein specified, then for those limits the operation microscope is a Group 2 instrument.
4.3.2 Emission limits
The operation microscope shall be tested to assess its compliance with the requirements of 5.4.1 in ANSI Z80.36. For those limits for which the operation microscope fulfills the requirements of 5.4.1, the operation microscope is a Group 1 instrument, and there are no further requirements.
4.4.4 Stability of light intensity
The operation microscope shall be designed to ensure that, when operated at maximum output, differences in output due to aging, maintenance, servicing, and lamp and component replacements cannot reduce the time and/or number of pulses needed to reach the recommended maximum exposure below the level determined in accordance with 6.5 in ANSI Z80.36. This shall be applicable throughout the lifetime of the device when maintained in accordance with the manufacturer’s specifications.
Among other methods, this may be achieved by a nsk management process.
5 Test methods
See 5.3 of ANSI Z80.36.
To assess compliance with Group 1 limits expressed in 6.1, 6.2, and 6.4 in ANSI Z80.36, appropriate measurement methods as specified in annex D and annex E in ANSI Z80.36 are to be used.
For limits that are found to be Group 2, 6.3 and 6.4 in ANSI Z80.36 apply, using appropriate measurement methods as specified in annex D and annex E in ANSI Z80.36, 6.5.1 in ANSI Z80.36, and 6.5.2 in ANSI Z80.36 (if applicable). For compliance with 6.5.3 and 6.5.4 in ANSI Z80.36, the time reported to reach the recommended maximum exposure shall be calculated using the radiant exposure value 10 J/cm2.
NOTE — It is assumed that the value of 10 JIcm2 is approximately equivalent to actual exposure of 2.2 J/cm2 for the patient under typical surgical conditions of blur and intermittent occlusion of the retinal image during the surgery.
6 Additional information to be supplied by the manufacturer of Group 2 instruments
6.1 Time to reach recommended maximum exposure for photochemical aphakic weighted retinal radiant exposure — Continuous wave light sources
For continuous wave light sources that can be varied in intensity, the time needed to reach the recommended maximum exposure in accordance with 6.5.1 in ANSI Z80.36, for the maximum setting and for 50% of the maximum setting shall be indicated in the user’s manual (see clause 7 in ANSI Z80.36). The time needed to reach these recommended maximum exposure levels shall be provided for both the instance of using the retinal protection device and the instance of not using it.
This information shall also be clearly evident to the user during surgery (see clause 7 in ANSI Z80.36). An example of how this information may be provided is given in annex A.
6.2 Number of pulses to reach recommended maximum exposure for photochemical aphakic retinal radiant exposure — Pulsed light sources
Where applicable, for pulsed light sources that can be varied in intensity, the number of pulses needed to reach the recommended maximum exposure in accordance with 6.5.2 in ANSI Z80.36, for the maximum setting and 50% of the maximum setting shall be indicated in the user’s manual (see clause 7 in ANSI Z80.36). The number of pulses needed to reach these recommended maximum exposure levels shall be provided for both the instance of using the retinal protection device and the instance of not using it.
7 Marking
For the marking of operation microscopes, see ISO 10936-1.ANSI Z80.38 pdf download.
