Power connection
Power cord with power plug with ground
Enclosure Protection
IP 20
Protection Class
I
Device type
B (according to EN 60601-1)
Dimensions:
Bench space
390 mm x 300 mm
Height
max. 610 mm (headrest)
Mass
approx. 18 kg
Ambient conditions for intended use
Temperature:
+10 … +35 °C
Relative humidity:
30 … 75%
Air pressure:
800 … 1060 hPa
Storage conditions
Temperature:
-10 … +55 °C
Relative humidity:
10 … 95%
Air pressure:
500 … 1060 hPa
Shipment conditions
Temperature:
-40 … +70 °C
(in original packing)
Relative humidity:
10 … 95%
Air pressure:
500 … 1060 hPa
Measuring range:
Axial length
Range
14 … 40 mm
Resolution of result display
0.01 mm
Corneal radius
Range
5 … 10 mm (33 … 67 D)
Resolution of result display
0.01 mm
Anterior chamber depth
Range
1.5 … 6.5 mm (33 … 67 D)
Resolution of result display
0.01 mm
White To White (optional)
Range
8 … 16 mm (33 … 67 D)
Resolution of result display
0.1 mm
Measurement information
Comparison results of IOL Master versus conventional measurements at the human eye*:
Mean values of Differences Standard Deviations
Axial length**
-0.01 mm
±0.19 mm
Corneal radius***
-0.01 mm
±0.05 mm
Anterior chamber depth**
0.07 mm
±0.18 mm
IOL Master measuring reproducibility*:
Regarding the human eye Regarding the artificial model eye
Standard deviation**** Standard deviation
Axial length**
-0.03 mm
±0.01 mm
Corneal radius***
-0.02 mm
±0.02 mm
Anterior chamber depth**
0.10 mm
±0.10 mm
* Data on file
** Compared to high precision ultrasound immersion device
*** Compared to handheld keratometer
**** Standard deviation determined on basis of "xi" calculated single standard deviations.
Optical radiation
Surrounding field illumination/
WTW determination:
Wavelength
880 nm
Delivered power
< 100µW(Limit value1:275 µW)
Axial length measurement:
Light source
Semiconductor diode laser (MMLD)
Wavelength
780 nm
Max. power for measurement
450 µW(Limit value1: 1200 µW, t=0.5 s) Max. power for alignment
80 µW(Limit value1: 173 µW, t=3.104 s) Measuring time for individual
measurement, Pulse width
0.5 s
Number of possible individual
measurements
20 per eye and day (The limit value for one eye will be exceeded
only by 51 individual measurements in direct
succession. This is impossible if used as
intended.)
Laser class
• In intended use
1
• Embedded Laser Class
(not accessible)
3B
Fixation light for keratometer, ACD measurement and
WTW determination:
(in spectral region from 860 to 1,100 nm no
emission of light source detectable)
LB (phakic eye)122.8 W (m2sr)–1
(Limit value2: 800 W (m2sr)–1) LA (aphakic eye)125.5 W (m2sr)–1
(Limit value2: 800 W (m2sr)–1)
1 AEL Class 1 acc to EN 60825-1 2 acc. to DIN EN ISO 15004
Spectral irradiance:
Spectral irradiance (white LED) in optical axis (0°) and in 33° –direction:
"Optical axis" or "0°" corresponds to the direct view into the illuminating projector; 33° is the angle for the intended use in anterior chamber depth measurement.
Photochemical radiation density of slit illumination (white LED) for phakic eyes LB=122.8 W/(m2 sr)
Photochemical radiation density of slit illumination (white LED) for aphakic
eyes LA=125.5 W/(m2 sr)
Note:
The spectrally assessed photochemical radiation densities LB and LA are a measure of the possibility of photochemical damage of the retina thought light. LB represents the measure for the phakic eye. LA represents the measure for the aphakic eye or for the eyes of very young children. Values of LB and LA above 800 W(m2sr)–1 are regarded as high. The radiation dose of the retina for a photochemical risk is calculated as the product of radiation density and exposure time. The recommended radiation dose is based on calculations of the American Conference of Governmental and industrial Hygienists (ACGIH) Threshold Limit Values for Chemical Substances and Physical Agents (Edition: 1995-1996).
The measured photometric values of the IOL Master are far below the levels that
are regarded as high. Thus, the risk of damage through optical radiation is extremely
low. Nevertheless, anterior chamber depth measurement with the IOL Master should
be limited to the time absolutely necessary for the diagnosis. The risk of damage
may be high, if fundus photography of the patient to be examined has been taken
within the last 24 hours.
Compliance with standards and regulations:
The IOL Master complies with the following standards and regulations:
Medical Product Act:
The device meets the requirements of the EC Medical Device
Directive 93/42/EEC and of their national equivalent in form of the German Medical
Product Act (MPA).
Device Class as per MPA: lla
UMDNS-No.: 18-014
Please check back at regular intervals for updates. Zeiss IOL Master
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