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D-0126050 rev 1 - 270+ Operating Manual
6. TECHNICAL SPECIFICATIONS
6.1. STANDARD AND REGULATORY
The CE mark indicates that Amplivox Ltd meets the requirements of Annex II of the
Medical Device Directive.
The 270+ Audiometer is classified as a Class IIa device under Annex IX (Section 1) of
the EU Medical Device Directive.
Standards and
Conformance
IEC 60601-1 (plus UL, CSA & EN deviations)
Type 2 (IEC 60645-1:2001)
Type B-E (IEC 60645-2:1993)
Type 3BE (ANSI S3.6:2004)
L x W X H: 249 x 374 x 90 mm / 9.8 x 14.33 x 3.54 inch
(excluding connections)
100-240Vac; 50/60Hz; 0.5A
+15°C to +35°C / + 59°F to +95°F
30 % to 90 % RH (non-condensing)
Operating atmospheric
pressure:
Transport: storage
temperature:
-20°C to +70°C / -4°F to +94°F
Transport and storage
humidity:
10 % to 90 % RH (non-condensing)
Transport and storage
atmospheric pressure:
Type of protection
against electric shock:
Powered via SELV ClassII mains adapter
Degree of protection
against electric shock:
Degree of protection
against ingress of water:
Any recording can be stored once the tone or speech
audiogram was taken. Special tests cannot be stored.
THL, MCL, UCL threshold
Speech SRT score
Tone audiogram in table format for THL, MCL, ULL
(UCL) and BC for left and right ear; space for patient
details to be entered.