Technical Specifications; Compliance; Directives With Which The Device Is Compliant; Classification Of The Device - Zeiss AT 030 Product Documentation Set

Instruction for use
AT 030
319300-9120-000-GA-GB-240320

9 Technical specifications

9.1 Compliance

If modifications not authorized by the manufacturer are made to
the device, this declaration ceases to be valid.

9.1.1 Directives with which the device is compliant

The device complies with the 93/42/EEC Medical devices directive
(MDD)
Device class in accordance with the MDD: I (with measuring
function)
The device is marked with

9.1.2 Classification of the device

UMDNS No.: 16-809
The AT 030 applanation tonometer conforms to the ISO 8612:2009
standard.

9.2 Device data

Measuring prism
Diameter of applanation
surface
Measuring force range of
precision spring tonometer
Scale reading
Measurement accuracy
9 Technical specifications
Value
2 prisms for image splitting
3.06 mm
0 mN to 78.4 mN
0.98 mN
according to ISO 8612:2009
9.81 ± 0.49 mN
19.61 ± 0.49 mN
29.42 ± 0.49 mN
39.23 ± 0.59 mN
49.03 ± 0.74 mN
58.84 ± 0.88 mN
68.65 ± 1.03 mN
78.45 ± 1.18 mN
9.1 Compliance
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