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USA Code of Federal Regulations. 21 CFR Part 801. §
801.109(b)(1)

UL recognized component for Canada and the United
States.

Electronic equipment covered by the Directive
2002/96/EC on waste electrical and electronic equipment
(WEEE).

All electrical and electronic products, batteries, and accu-
mulators must be taken to separate collection at the end
of their working life. This requirement applies in the
European Union. Do not dispose of these products as
unsorted municipal waste.

You can return your device and accessories to Otometrics,
or to any Otometrics supplier. You can also contact your
local authorities for advice on disposal.

6.2

HI-PRO 2 Warning notes

When connecting equipment to the USB connector, the following
must be considered:

Equipment must be certified to relevant EN/IEC safety stand-
ards, e.g. EN/IEC 60950.

Use of connected equipment in a patient environment, see
Note 1.

Ensure that the electro-medical system complies with the require-
ments of IEC 60601-1:2005+AMD1:2012 and EN 60601-
1:2006+A1:2013.

1. The HI-PRO 2 is a part of an electromedical system. When assembling an elec-

tromedical system, the person carrying out the assembly must take into account
that connecting other equipment that does not comply with the same safety
requirements as the HI-PRO 2 may lead to a reduction in the overall safety level
of the system.

The HI-PRO 2 is designed to ensure compliance with requirements in IEC 60601-
1:2005+AMD1:2012 and EN 60601-1:2006+A1:2013 when the PC, printer, etc.

Otometrics - HI-PRO 2

19

Summary of Contents for otometrics HI-PRO 2

Page 1: ...HI PRO 2 Installation Manual Doc No 7 50 0980 EN 03 Part No 7 50 09800 EN...

Page 2: ...d Otometrics the Otometrics Icon AURICAL MADSEN Otoscan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 2019 02 05 2068...

Page 3: ...ble of Contents 1 Introduction to HI PRO 2 4 2 When you receive HI PRO 2 5 3 Installation 6 4 Service and Maintenance 9 5 Technical Specifications 10 6 Safety 18 7 Manufacturer 20 Otometrics HI PRO 2...

Page 4: ...les for connecting hearing instruments to HI PRO 2 are supplied by the hearing instrument manufacturer 1 1 Intended use HI PRO 2 is intended for audiologists hearing instrument dispensers and other he...

Page 5: ...ient or risk of damage to data or the device Note Indicates that you should take special notice 2 When you receive HI PRO 2 2 1 Unpacking and inspection 1 Unpack your HI PRO carefully When you unpack...

Page 6: ...ollow the guidelines below Store HI PRO 2 and accessories in the box provided to protect the equipment from damage Store HI PRO 2 as stated in Technical Specifications 3 Installation Site the HI PRO 2...

Page 7: ...y double clicking the icon on the desktop double click on the CD drive icon then double click on the Setup application icon to start the installation Follow the instructions on the screen 3 2 Connecti...

Page 8: ...icate communication with the PC Caution Do not attempt to connect or disconnect a hearing instrument while the connector LED is active The LED indicates that the connector is act ive and this might da...

Page 9: ...o circumstances disassemble HI PRO 2 Contact your supplier Parts inside HI PRO 2 must only be checked or serviced by authorized personnel Warning Do not disassemble the HI PRO 2 as there is a risk of...

Page 10: ...port is used for communication between a PC and the HI PRO 2 unit Communication USB 2 0 full Speed USB 1 1 compatible USB Connector Type Type B connector on the HI PRO 2 unit Power Supply The HI PRO...

Page 11: ...hearing instrument must meet the following requirements No conductive parts may be accessible when the programming cable is con nected to HI PRO 2 unit The programming cable and the connector must pr...

Page 12: ...t Size L x W x H 137 mm x 114 mm x 37 mm 5 39 inch x 4 49 inch x 1 46 inch Net weight 230g 0 43 lb 5 1 Accessories Item Part number 1072 HI PRO 2 Installation CD 8 49 91200 USB Cable 3 meters 8 71 791...

Page 13: ...ower supply network that supplies buildings used for domestic pur poses Guidance and manufacturer sdeclaration electromagnetic immunity for all equipment and systems HI PRO 2 is intended for use in th...

Page 14: ...GHz 10 V m 80 MHz to 2 7 GHz Proximity fieldsfrom RF wirelesscom munications IEC 61000 4 3 27 V m 386 MHz 28 v m 450 MHz 9 v m 710 MHz 745 MHz 780 MHz 28 v m 810 MHz 870 MHz 930 MHz 28 v m 1720 MHz 18...

Page 15: ...lies buildings used for domestic pur poses Guidance and manufacturer sdeclaration electromagnetic immunity for all equipment and systems HI PRO 2 is intended for use in the electromagnetic environment...

Page 16: ...HI PRO 2 including cables than the recommended separation distance cal culated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 d 1 2 for 80 MHzt...

Page 17: ...e is observed additional measures might be necessary such as reorienting or relocating HI PRO 2 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separ...

Page 18: ...1 2005 AMD1 2012 and EN 60601 1 2006 A1 2013 Class II equipment Follow instructions for use Consult user manual for warnings and cautions Complies with Medical Devices Directive 93 42 EEC and RoHS Di...

Page 19: ...s When connecting equipment to the USB connector the following must be considered Equipment must be certified to relevant EN IEC safety stand ards e g EN IEC 60950 Use of connected equipment in a pati...

Page 20: ...f HI PRO 2 6 No parts may be eaten burnt or in any way used for purposes other than the fitting of hearing aids or similar devices 7 For safety reasons and due to effects on EMC accessories connected...

Page 21: ...arried out by the equipment manufacturer or personnel authorized by the man ufacturer The electrical installation to which the equipment is connected complies with EN IEC requirements The equipment is...

Page 22: ......

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