Maico MA 33 - Page 76

Operation Manual MA 33
8100092 Rev. 9
74
19/08/2019
6 Technical Specifications
This section offers you important information about
▪ the MA 33 hardware and software specifications
▪ connections
▪ the pin assignment
▪ immittance and audiometry calibration values
▪ electromagnetic compatibility (EMC)
▪ electrical safety, EMC and associated standards
6.1 MA 33 Hardware and Software
The MA 33 is an active, diagnostic medical product according to the class IIa of
the EU medical directive 93/42/EEC.
General Information About Specifications
The performance and specifications of the device can only be guaranteed if it is
subject to technical maintenance at least once per year.
MAICO Diagnostics puts diagrams and service manuals at the disposal of
authorized service companies.
STANDARDS
Medical CE-mark
Yes
Safety Standards
IEC 60601-1:2005 +A1:2012 Class IIa, Type B applied parts
EMC Standard
IEC 60601-1-2
Audiometer
Standards
Tone and Speech: IEC 60645-1:2017/ANSI S3.6-2010
Type 4 (Air Conduction only)/Type 3 (with Bone)
Speech: class B
DEVICE SPECIFICATIONS
Environmental
conditions
Operation:
+15 °C to +35 °C / + 59 °F to +95 °F
Relative humidity 30 % to 90 % (non-condensing)
Atmospheric pressure 70 kPa
(≤ 3000 m above sea level)
Storage:
0 °C to + 50 °C / 32 °F to +122 °F
Humidity 10 to 95 % (non-condensing)
Transport:
-20 °C to + 50 °C / -4 °F to +122 °F
Humidity 10 % to 95 % (non-condensing)
Weight
300 g
Dimensions
W x D x H: 154 mm x 103 mm x 27 mm
(6.1 in x 4.1 in x 1.1 in)
Warm-up Time
Approx. 1 minute (incl. boot-up time)
Mode of Operation
Continuous
User Interface
PC-based audiometer
Language Settings
German, English, French, Italian, Spanish,
Netherlands, Polish