ANSI Z80.37 pdf free download
ANSI Z80.37 pdf free download.for Ophthalmics—Slit- Lamp Microscopes.
4.3 Construction and function
4.3.1 General
The following requirements shall apply:
a) the parallel slit edges shall be smooth and free from any imperfections when observed using the highest magnification;
b) the slit image shall be evenly illuminated;
c) no contrast decrease in the slit image caused by reflections or scattered light shall be observed;
d) the brightness and color transmission of the left and right optical systems shall be identical;
e) at the highest magnification, the resolving power in the center of the field shall be at least 1 800 N. Compliance with these requirements is checked by observation.
4.3.2 High eye point eyepiece
If the manufacturer states that the eyepiece is a high eye point eyepiece, the distance between the exit pupil of the observation system and the nearest part of the eyepiece shall be not less than 17 mm.
4.4 Optical radiation hazard with slit-lamp microscopes
This subclause replaces IEC 60601-1:2005 + Amd.1:2012, 10.4, 10.5, 10.6, and 10.7. Slit-lamp microscopes shall comply with the light hazard protection requirements given in ANSI Z80.36.
It shall first be determined if the slit-lamp microscope is classified as a Group 1 or Group 2 instrument in accordance with ANSI Z80.36, Clause 4. The applicable clauses of ANSI Z80.36 for slit-lamp microscopes are listed below.
Values of EA measured for the purpose of calculating values for ANSI Z80.36, 5.4.2.3, 5.4.2.4, 5.5.1.5, and 5.5.2.1 for retinal radiation hazard shall be determined by measuring the spectral irradiance in the focal plane of the slit-lamp microscope and multiplying this value by 1.11.
a) for Group 1 slit-lamp microscopes:
1) applicable requirements of ANSI Z80.36 are 5.1, 5.2, and 5.4;
2) applicable test methods of ANSI Z80.36 are 6.1, 6.2, and 6.4;
3) if status is determined to be Group 1, there are no further requirements; if status is determined not to be Group 1, the additional requirements given in b) are applicable;
b) for Group 2 slit-lamp microscopes:
1) applicable requirements of ANSI Z80.36 are 5.1, 5.3, and 5.5;
2) applicable test methods of ANSI Z80.36 are 6.1, 6.2, 6.3, 6.4, and 6.5;
3) ANSI Z80.36, Clause 7, also applies.
If the intended use of the slit-lamp microscope includes the use of supplementary 90 D lenses, an arrangement shall be made for measurement of corneal- and lenticular-related exposure values. The 90 O lens (e.g., Volk lens) shall be at a position 7 mm beyond the focus plane of the slit-lamp microscope (i.e., between the focus plane and the nominal position of the eye) with the maximum illumination field. The exposure measurement is then taken approximately 7 mm beyond the 90 D lens at the position where the illumination field has a minimum size.
5 Accompanying documents
The slit-lamp microscope shall be accompanied by documents containing instructions for use. In particular, this information shall contain:
a) the name and address of the manufacturer;
b) if appropriate, a statement that the slit-lamp microscope in its original packaging conforms to the transport conditions as specified in ANSI Z80.36;
c) any additional documents as specified in IEC 60601-1:2005+ Amd.1:2012, 7.9;
d) a reference to this American National Standard, ANSI Z80.37, if the manufacturer or supplier claims compliance with it.
6 Marking
The slit-lamp microscope shall be permanently marked with at least the following information:
a) the name and address of the manufacturer or supplier;
b) the name and model of the slit-lamp microscope;
c) marking as required by IEC 60601-1:2005 + Amd.1:2012.ANSI Z80.37 pdf download.
