AmpliVox Otowave 302+ - Technical Specifications; Standard and Regulatory Compliance; General Device Specifications

TECHNICAL SPECIFICATIONS
49 OTOWAVE 302+ INSTRUCTION FOR USE
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 Regulation 2017/745. TÜV Product Service, Identification No. 123, has approved the
quality system.
Class
The Otowave 302+ Tympanometer is classified as a Class IIa device under Annex VIII of the EU
Medical Devices Regulation.
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
ANSI 3.39, 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