Operating Instructions MA 41
8100456_OI_MA41_EN_15a
42
8100456-8 04/15
12 Technical Data
The MA 41 audiometer is an active, diagnostic medical product
according to the class IIa of the EU medical directive 93/42/EEC.
Standards:
IEC60645-1 / EN 60645-1: Type 2
IEC60645-2: Type B
ANSI S3.6-1996 / ANSI S3.6-2010:
Type 3 B
ISO 389
UL 60601-1 American Standards for
Medical Electrical Equipment
IEC/EN 60601-1 class I, protection
class B, International Standards for
Medical Electrical Equipment
CAN/CSA C22.2 NO. 60601-1-08
Medical Device Directive (MDD) to
comply
with
“EC
Directive”
93/42/EEC
Test Frequencies:
125 Hz – 8,000 Hz
Level Step:
5 dB, 2 dB or 1 dB level steps (user
selectable)
Maximum Sound Pressure Level:
AC with earphone DD45:
- 10 dB
HL
to 120 dB
HL
BC with B71W Bone Conductor:
- 10 dB
HL
to 80 dB
HL