MedRx Avant REM+, Руководство пользователя

Страница: 39 / 40

D ‐ 0125127 ‐ C
39
Technical Information
The Avant REM+ is an active, diagnostic Class IIa Medical Device according to the EU Medical Device Regulation 2017/745.
Standards:
IEC 60601 ‐ 1:2 Class II
IEC 60601 ‐ 1 ‐ 2 Class A
IEC 60645 ‐ 1
Medical Device Regulation 2017/745
REM Standards: ANSI S3.46, IEC 61669, EN
61669
Dimensions: Approx. 16 cm x 12 cm x 3 cm (L x W x H)
Approx. 6.5 ″ x 5 ″ x 1.25 ″ (L x W x H).
Weight: < 500 g < 1 lb
System Modality: Real Ear Measurement; Binaural Live
Speech Mapping; Hearing Loss Simulator; Hearing
Instrument Simulator.
Probe Microphones (L/R): Dual Electret Microphone
Elements (2 Probe Microphones)
Probe Microphone Tube: Silicone 1.0 mm Nominal
Diameter
Measurement Frequency Range: 125 – 8000 Hz
Test Stimuli: Broadband Noise and Synthesized
Random Noise – Pink, White, Byrne LTASS and ANSI
weighted; ICRA; ISTS; Microphone, File, CD ‐ ROM for
Live Speech Mapping, Chirp
Test Stimulus Levels at 1m : 45 – 90 dB SPL in 1 dB
Steps – 200 Hz thru 8K Hz (depending on speaker
wattage & efficiency)
Test Stimulus Accuracy: ± 3 dB SPL
Analysis Mode: User Selectable 1/3, 1/6, 1/12, 1/24,
1/48 Octave Bands
ANSI S3.46 Test Available IEC/EN 61669: Real Ear
Unaided Response, Real Ear Unaided Gain; Real Ear
Insertion Gain; Real Ear Occluded Response; Real Ear
Occluded Gain; Real Ear Aided Response; Real Ear
Aided Gain
Other Test Available: Live Speech Mapping with Peaks
and LTASS analysis; Real Ear to Coupler Difference,
Occlusion Effect, Percentile Analysis
Prescription Methods: NAL ‐ RP; 1/3 Gain; 1/2 Gain;
Berger; Pogo 1; Pogo 2; FIG6; DSL m[I/O] NAL ‐ NL1;
NAL ‐ NL2
External Connections: Power Connection USB 2.0 Input
5.0 Volt Bus; Line ‐ Output Jack (Speakers) 3.5 mm
Stereo Jack; Speaker Output (Internal Amplifier) (2)
3.81mm Pluggable Spring Clamp; Probe Microphones
Inputs (2) 8 Pin Mini ‐ DIN; Operator Headset Jack 3.5
mm Stereo Jack; Patient Headset Jack 3.5 mm Stereo
Jack; Power Jack 2.1 mm
X 5.5 mm.
Communication: Talk forward and talk back
Data Connection: USB
Mode of Operation: Continuous
Warm up Time: Less than 5 min after USB connection
Weight: < 900 g < 2 lb
Power Supply:
100 ‐ 240 V~ 50/60 Hz ±10 %
producing 15 VDC
USB: 5 VDC
Power Consumption:
Less than 500 mA at 15 VDC / less than 500
mA at 5 VDC
Connection Sockets: Specification
Power/Communication USB: (5 VDC)
Power 15 VDC
Speaker left ZA= 4 Ω , UA= 8 Veff
Speaker right ZA= 4 Ω , UA= 8 Veff
Operator Monitor
headphone
ZA= 32 Ω , UA= 3 Veff
Left Probe ZI= 1 k Ω , UI= 0.38 – 500
mVeff
Right Probe ZI= 1 k Ω , UI= 0.38 – 500
mVeff
Patient (Client)
headphone
ZA= 32 Ω , UA= 3 Veff
Line Level Stereo
Speaker Output
ZA= 32 Ω , UA= 3 Veff