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D-0126050 rev 1 -
270+ Operating Manual
6.
TECHNICAL SPECIFICATIONS
6.1.
STANDARD AND REGULATORY
Medical CE mark
The CE mark indicates that Amplivox Ltd meets the requirements of Annex II of the
Medical Device Directive.
Class
The 270+ Audiometer is classified as a Class IIa device under Annex IX (Section 1) of
the EU Medical Device Directive.
Standards and
Conformance
Safety:
IEC 60601-1 (plus UL, CSA & EN deviations)
EMC:
IEC 60601-1-2
Performance:
Type 2 (IEC 60645-1:2001)
Type B-E (IEC 60645-2:1993)
Type 3BE (ANSI S3.6:2004)
Physical
Display:
2 lines of 24 characters
Dimensions (base unit):
L x W X H: 249 x 374 x 90 mm / 9.8 x 14.33 x 3.54 inch
(excluding connections)
Weight (base unit):
1400g / 3.08 lbs
Power Supply
Mains power:
100-240Vac; 50/60Hz; 0.5A
Warm-up period:
None at room temperature
Environmental
Operating temperature:
+15°C to +35°C / + 59°F to +95°F
Operating humidity:
30 % to 90 % RH (non-condensing)
Operating atmospheric
pressure:
700 hPa to 1060 hPa
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:
500 hPa to 1060 hPa
Equipment
Classification
Type of protection
against electric shock:
Powered via SELV ClassII mains adapter
Degree of protection
against electric shock:
Type B applied part
Degree of protection
against ingress of water:
Not protected
Mode of operation:
Continuous operation
Equipment mobility:
Portable
6.2.
GENERAL
Languages:
English, German
Database
No. of records stored:
10
Data storage:
Any recording can be stored once the tone or speech
audiogram was taken. Special tests cannot be stored.
Data held:
THL, MCL, UCL threshold
Speech SRT score
Printing
Supported printer:
Sanibel MPT-II
Interface:
Cable supplied
Information printed:
Tone audiogram in table format for THL, MCL, ULL
(UCL) and BC for left and right ear; space for patient
details to be entered.
Содержание 270+
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