natus otometrics HI-PRO 2 Installation Manual

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HI-PRO 2

Installation Manual

Doc. No. 7-50-0980-EN/03

Part No. 7-50-09800-EN

Table of Contents

Summary of Contents for natus 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 Copyright notice © 2015, 2019 Natus Medical Denmark ApS. All rights reserved. ® 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 (206837) Technical support Please contact your supplier.
Page 3: Table Of Contents
Table of Contents Introduction to HI-PRO 2 When you receive HI-PRO 2 Installation Service and Maintenance Technical Specifications Safety Manufacturer Otometrics - HI-PRO 2...
Page 4: Introduction To Hi-Pro 2
Introduction to HI-PRO 2 The HI-PRO 2 Hearing Instrument Programming Unit together with fitting software and programming cables constitute the complete HI-PRO 2 system. The HI-PRO 2 hardware serves as a standardized interface between a PC and programmable hear- ing instruments. Connection to the PC is by means of the supplied USB (Universal Serial Bus) cable. The USB connection both establishes the electrical power and the data com- munication between the PC and the HI-PRO 2.
Page 5: When You Receive Hi-Pro 2
also be followed at all times. Safety information is stated where it is relevant, and ► general safety aspects are described in Safety 1.2.2 Typographical conventions The use of Warning, Caution and Note To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses precautionary statements as follows: Warning Indicates that there is a risk of death or serious injury to the user or...
Page 6: Installation
4. If your package is incomplete, contact your supplier. HI-PRO 2 front and rear view HI-PRO 2 front view HI-PRO 2 rear view Storage and shipment If you need to store HI-PRO 2 before you put it into operation, follow the guidelines below: • Store HI-PRO 2 and accessories in the box provided to protect the equipment from damage.
Page 7 Installing the HI-PRO 2 software Note You are required to log on with Administrator rights to install this soft- • ware. • Place the installation CD in the CD drive. Autorun • If the feature is enabled on your computer, the installation will start automatically when the CD is inserted, otherwise My Computer •...
Page 8 Note If the HI-PRO 2 unit is connected to the PC via a USB hub, the hub must • be self-powered (have a separate power supply). This is to ensure that the USB hub can deliver enough current for proper operation of the HI-PRO 2 unit. Starting up HI-PRO 2 When the HI-PRO 2 Installation CD is installed, HI-PRO 2 powers on as soon as the unit is connected to the PC and the PC is powered ON.
Page 9: Service And Maintenance
the HI-PRO 2 or from the PC. Caution Do not attempt to disconnect the USB cable while a hearing instru- • ment is being fitted. Doing so might damage the hearing instrument or set it in an undefined state. Service and Maintenance Equipment failure, service, and repair Warning Do not use a defective device.
Page 10: Technical Specifications
Use a soft, slightly damp cloth with a small amount of detergent to clean the unit. Technical Specifications Type identification HI-PRO 2 is type 1072 from Natus Medical Denmark ApS. PC Interface The serial USB (Universal Serial Bus) port is used for communication between a PC and the HI-PRO 2 unit.
Page 11 Essential performance HI-PRO 2 has no essential performance. Standards Safety IEC 60601-1:2005+AMD1:2012 EN 60601-1:2006+A1:2013 ANSI/AAMI ES60601-1:2005 + A1:2012 CAN/CSA-C22.2 NO. 60601-1:14 IEC 60601-1-2:2007 EN 60601-1-2:2007 IEC 60601-1-2:2014 EN 60601-1-2:2015 Systems IEC 60601-1:2005+AMD1:2012 EN 60601-1:2006+A1:2013 Hearing Instrument IEC 60118-14:1998 Interface EN 60118-14:1998 To comply with the above standards, the programming cable and the connector to the hearing instrument must meet the following requirements: •...
Page 12 Operating environment Temperature +5°C to +40°C (41°F to +104°F) Rel. humidity 30 to 90%, non-condensing Warm-up time < 20 seconds. Air pressure 600 hPa to 1060 hPa Operation at temperatures below -20°C or above +60°C may cause permanent damage. Storage and handling Temperature -25°C to +70°C (-13°F to +158°F) Rel.
Page 13 • Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of HI-PRO 2. IEC 60601-1-2:2014 and EN 60601-1-2:2015 Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems HI-PRO 2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO 2 should ensure that it is used in such an environment.
Page 14 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment HI-PRO 2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO 2 should ensure that it is used in such an environment. Immunity test IEC 60601 Compliance level...
Page 15 IEC 60601-1-2:2007 and EN 60601-1-2:2007 Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems HI-PRO 2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO 2 should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
Page 16 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting HI-PRO 2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO 2 should ensure that it is used in such an environment. Immunity test IEC 60601 Compliance level...
Page 17 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting Note 1 : At 80 MHz and 800 MHz the separation distance for the higher frequency range applies. Note 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp- tion and reflection from structures, objects and people.
Page 18: Safety
Safety This manual contains information and warnings, which must be followed to ensure the safe performance of HI-PRO 2. Local government rules and regulations, if applic- able, should also be followed at all times. HI-PRO 2 symbols Complies with Type BF requirements of IEC 60601- 1:2005+AMD1:2012 and EN 60601-1:2006+A1:2013.
Page 19 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.
Page 20: Manufacturer
10. Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your supplier for advice. Manufacturer Natus Medical Denmark ApS Hoerskaetten 9, 2630 Taastrup Denmark +45 45 75 55 55 www.otometrics.com...
Page 21 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only if: • All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment manufacturer or personnel authorized by the man- ufacturer.