-27-
-28-
Follow operating instructions
B type applied part
Disposal in accordance with Directive 2002/96/EC (WEEE)
Date of manufacture
Serial number
Warning/ Danger: Improper use might cause serious injuries.
IP code of the device: this device’s grade of against ingress
of solid foreign objects – the access probe of ≥ Ø12.5 mm
shall not penetrate; the grade of waterproof is vertically
falling drops shall have no harmful effects.
IP21
XI. NORMALIZED SYMBOLS
Permissible storage and transport temperature and humidity
Permissible operating temperature and humidity
IX.TECHNICAL SPECIFICATION
Charging Case:1
Hearing Aids: 2
Ear Dome: 6
Manual: 1
USB Cable: 1
Adapte
：
1
Input
：
100-240V~50/60Hz 0.2A
Output
：
5V 1A 5W
* Optional accessories list:
X.Accessories List
Output. OSPL
90
Max.
High frequency average OSPL
90
EQ Input Noise
Total Harmonic Distortion
Frequency Range
(Not narrower than )
Working Current
≤115dB+3dB
≤29dB+3dB
≤2%+3%
10mA
450Hz-4000Hz
108dB±4dB
Item
Charging case Input voltage
Charging case Input current
Charging case Output current
Charging case Output voltage
Charging Case
d.c.5.0V
≤1000mA
≤100mA
d.c.4.2V
Operating temperature/humidity
Storage temperature/humidity
0
℃
~+40
℃
(32
℉
-104
℉
),
≥30%RH,≤75%RH
-10
℃
~+55
℃
(14
℉
-131
℉
),
≥10%RH,≤90%RH
Complies with the European Medical Device Directive
(93/42/EEC and amended Directive 2007/47/EC. Notified
Body is SGS Belgium.
Manufacturer information
Shanghai International Holding Corp. GmbH(Europe)
Address:Eiffestrasse 80,20537 Humburg,Germany
Notes:This hearing aid is produced under the strict quality system of Huizhou
JINGHAO Medical Technology Co.,Ltd.
The device fulfils the provisions of the EC directive 93/42/EEC (Medical Device
Directive) and the Harmonize Standard as IEC 60601-1, IEC 60601-2-66, IEC
60118-7, IEC 60118-13, EN ISO 10993-1/-5/-10 and EN ISO 14971.
*Notice: The above parameter index testing is on basis of FONIX8000Hearing Aid Test
System;Inspection standard: IEC 60118-7 2005, 2CC coupling cavity HA-1
