TECHNICAL SPECIFICATIONS
43
D-0115696-C (OM038)
– Otowave 302 Operating Manual
7.
TECHNICAL SPECIFICATIONS
7.1.
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 Otowave 302 Tympanometer is classified as a Class IIa device under Annex IX
(Section 1) of the EU Medical Devices Directive.
Standards and
Conformance
Safety:
IEC 60601-1 (plus ES, CSA & EN deviations), Class II,
Type B applied part
EMC:
IEC 60601-1-2
Performance:
IEC 60645-5, Type 2 Tympanometer
Physical
Display:
256 x 64 pixels / 8 lines of 21 characters
Dimensions (base unit):
270 x 70 x 175 mm / 10.63 x 2.75 x 6.89 inch
(excluding connections)
Weight (base unit):
760 g / 1.68 lbs
Dimensions (probe):
130 x 25 mm / 5.11 x 0.98 inch
Weight (probe):
115 g / 0.25 lbs
Interconnection:
(probe to base)
1.5 m combined electrical cable and air tube
Power Supply
Mains power:
100-240 Vac; 50/60 Hz; 0.4 A
Warm-up period:
None at room temperature
Idle current:
70 mA
Current while testing:
230 mA
Environmental
Operating temperature:
+15°C to +35°C / + 59°F to +95°F
Operating humidity:
30 % to 90 % RH (non-condensing)
Operating
atmospheric
pressure:
980 mb to 1040 mb
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:
900 mb to 1100 mb
7.2.
GENERAL
Time and Date
Stamps:
Time and date stamp applied to all recordings, and to
the last calibration date
Languages:
English, German, French, Spanish, Portuguese, Italian
Database
No. of records stored:
36
Data storage:
Any recording can be stored once the tympanogram is
viewed. Patient Initials (A-Z, 0-
9, “-“) must be entered
before storage.
Data held:
Patient Initials, Tympanogram and Reflex graphs and
analysis for Left Ear and/or Right Ear, Time and Date
of recording, which ears were tested, whether or not
the record has been printed and/or sent to a computer,
parameters used for analysis, 128 bit Globally Unique
Identifier (GUID)
Data presentation:
Records listed in reverse chronological order (latest
first), with indication of data stored as described above
