HI-PRO USB Installation Guide Rev 01

HI-PRO USB Installation Guide

Contents 1

Introduction to HI-PRO USB

5

1.1 1.2

Intended use About this manual 1.2.1 Safety 1.2.2 Typographical conventions

5 5 6 6

2

When you receive HI-PRO USB

6

2.1 2.2 2.3

Unpacking and inspection HI-PRO USB front and rear view Storage and shipment

6 7 7

3

Installation

8

3.1 3.2 3.3

Installing the HI-PRO USB software Connecting the HI-PRO USB to the PC Starting up HI-PRO USB

8 8 9

4

Service and Maintenance

10

4.1 4.2

Equipment failure, service, and repair Maintenance

10 10

5

Safety

10

5.1 5.2 5.3

HI-PRO USB symbols HI-PRO USB Warning notes Manufacturer 5.3.1 Responsibility of the manufacturer

11 11 12 12

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HI-PRO USB Installation Guide

6

Technical Specifications

14

6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10

PC Interface Power Supply Output ratings Type identification Operating environment Storing and handling Dimensions and Weight Patient Safety Product Lifetime Standards

14 14 14 14 14 15 15 15 15 15

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HI-PRO USB Installation Guide

1

Introduction to HI-PRO USB

The HI-PRO Hearing Instrument Programming Unit together with fitting software and programming cables constitute the complete HI-PRO system. The HI-PRO hardware serves as a standardized interface between a PC and programmable hearing 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 communication between the PC and the HI-PRO. On the cabinet front two 6-pole mini-DIN connectors for the cables to the programmable hearing instruments facilitate programming of both a left and a right hearing instrument. The PC sends information about the communication protocol (e.g. communication type, voltage levels, and clock frequency) and orders the HI-PRO to read from or write data to the programmable hearing instrument. The PC software for programming the hearing instrument (Fitting Software) is supplied by the hearing instrument manufacturer. The cables for connecting hearing instruments to HI-PRO are also supplied by the hearing instrument manufacturer.

1.1

Intended use

HI-PRO USB is intended for audiologists, hearing instrument dispensers, and other health care professionals. The intended use is to make the necessary adjustments to programmable hearing instruments connected to the HI-PRO unit.

1.2

About this manual

This manual is your guide to installing and using the HI-PRO USB. We strongly recommend that you read this manual carefully before using your HI-PRO USB for the first time. The manual contains a description of the main functions of HI-PRO USB. GN Otometrics recommends that you make yourself familiar with the following issues in particular: 5

HI-PRO USB Installation Guide

•

2, ‘When you receive HI-PRO USB” on page 6

•

3, ‘Installation” on page 8

•

5, ‘Safety” on page 10

1.2.1 Safety This manual contains information which must be followed to ensure the safe performance of HI-PRO USB. Local government rules and regulations, if applicable, should also be followed at all times. Safety information is stated where it is relevant, and general safety aspects are described in 5, ‘Safety” on page 10. 1.2.2 Typographical conventions The use of Warning, Caution and Note For safety reasons and appropriate use of OTOsuite, the manual contains Warnings, Cautions and Notes, which you should read carefully. The use of these headings is denoted as follows: Warning: A warning indicates that there is a risk of danger to persons and data. Caution: Caution indicates that there is a risk of damage to data. Note: A note indicates that you should take special notice.

2

When you receive HI-PRO USB

2.1

Unpacking and inspection

1. Unpack your HI-PRO carefully. When you unpack HI-PRO, it is a good idea to keep the packing material in which it was delivered. If you need to send the HI-PRO in for service, the original packing material will protect against damage during transport, etc. 2. Inspect the equipment for possible visual damage. If damage has occurred, do not put the HI-PRO into operation. Contact your supplier for assistance.

6

HI-PRO USB Installation Guide

3. Check that the package includes the items listed below: •

HI-PRO USB unit

•

USB interface cable

•

Software Installation CD

•

Installation Guide

4. If your package is incomplete, contact your supplier.

2.2

HI-PRO USB front and rear view

HI-PRO USB front view

!

HI-PRO USB rear view

2.3

Storage and shipment

If you need to store HI-PRO before you put it into operation, follow the guidelines below: •

Store HI-PRO and accessories in the box provided to protect the equipment from damage.

7

HI-PRO USB Installation Guide

•

Store HI-PRO as stated in the 6.6, ‘Storing and handling” on page 15.

3

Installation

•

Site the HI-PRO USB unit in a well-ventilated location away from all liquids and sources of heat.

•

An installation CD is provided with your HI-PRO USB. Before you connect the HIPRO USB unit to the PC, this software must be installed.

3.1

Installing the HI-PRO USB software

Note: You are required to log on as an Administrator to install this software on Windows 2000, XP and Vista systems. •

Place the installation CD in the CD drive.

•

If the Autorun feature is enabled on your computer, the installation will start automatically when the CD is inserted, otherwise

•

Open My Computer by 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

Connecting the HI-PRO USB to the PC

Note: An installation CD is provided with your HI-PRO USB. Before you connect the HI-PRO USB unit to the PC, this software must be installed. •

Connect the USB connector on the rear of HI-PRO USB to a USB port of a personal computer (PC) by means of the supplied USB cable. See Fig. 1.

!

Fig. 1 8

HI-PRO USB Installation Guide

Note: If the HI-PRO USB 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 USB unit.

3.3

Starting up HI-PRO USB

When the HI-PRO USB Installation CD is installed, HI-PRO powers on as soon as the unit is connected to the PC and the PC is powered ON. During power-up, the LEDs next to the connectors on the front panel will flash once indicating that a brief self-test is in progress. When the self-test is completed, only the power LED will light. If only the left LED flashes, the self-test has failed and you should try powering on again. Should the unit fail again, contact your local distributor. The HI-PRO connector LEDs will also light up when a hearing instrument is being programmed, indicating which side is active. The LED above the text ‘PC Com’ lights up to indicate 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 active, and this might damage the hearing instrument. Caution: Even though the hearing instrument connectors on the front of the HI-PRO are galvanically insulated from the PC and mains earth, it is still possible to release an electrostatic discharge (ESD) to a connected hearing instrument, and through the HI-PRO to earth. An electrostatic discharge can be very uncomfortable for the client because it feels like a minor "electric shock", and can even produce loud pulses of noise. Cases of electrical damage to hearing instruments have been reported. High levels of static electricity are usually experienced in areas where the indoor climate is very dry, and where synthetic materials (e.g. carpets) are used. Please take the necessary steps to prevent build-up of static electricity before using the HIPRO.

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HI-PRO USB Installation Guide

4

Service and Maintenance

4.1

Equipment failure, service, and repair

Warning: Do not use a defective device. If you suspect that the correct function or operation safety of the HI-PRO may be faulty in any way, disconnect HI-PRO USB from the PC, and make sure that it cannot be used by others until it has been serviced. Warning: Under no circumstances disassemble the HI-PRO. Contact your supplier. Parts inside the HI-PRO must only be checked or serviced by authorized personnel. Warning: Do not disassemble the HI-PRO as there is a risk of electric shock. For the sake of safety and in order not to void the warranty, service and repair of electromedical equipment should be carried out only by the equipment manufacturer or by service personnel at authorised workshops. In case of any defects, make a detailed description of the defect(s) and contact your supplier. The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. Following repair, the equipment should be tested by suitably qualified personnel. On request, your supplier can obtain a Service Manual from the manufacturer.

4.2

Maintenance

HI-PRO requires no preventive maintenance. However, it is recommended that you observe the guidelines below. •

5

Use a soft, slightly damp cloth with a small amount of detergent to clean the unit.

Safety

This manual contains information and warnings, which must be followed to ensure the safe performance of HI-PRO USB. Local government rules and regulations, if applicable, should also be followed at all times.

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HI-PRO USB Installation Guide

5.1

HI-PRO USB symbols HI-PRO USB is marked with this symbol to indicate compliance with Type BF of the safety standard EN 60601-1. See 6.10, ‘Standards” on page 15. HI-PRO USB is marked with this symbol when it is important that the user refers to associated information given in this manual.

HI-PRO USB is CE-marked according to the Medical Devices Directive 93/42/EEC.

The instrument is marked with this symbol to indicate that it is electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment (WEEE). This symbol indicates a UL recognized component for Canada and the United States.

5.2

HI-PRO USB Warning notes When connecting equipment to the USB connector, the following must be considered: •

Equipment must be certified to relevant EN/IEC safety standards, e.g. EN/IEC 60950.

•

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

Ensure that the electro-medical system comply with requirements of EN 60601-1-1 Note 1: The HI-PRO USB is a part of an electromedical system. When assembling an electromedical 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 USB may lead to a reduction in the overall safety level of the system. 11

HI-PRO USB Installation Guide

The HI-PRO USB is designed to ensure compliance with requirements in EN 60601-1-1 when the PC, printer, etc. are placed out of reach of the patient, i.e. not closer than approx. 1.8 meters/6 ft. Note 2: There are no user-serviceable parts inside the HI-PRO USB device cabinet. For the sake of safety, and in order not to void the warranty, the cabinet should only be opened and serviced by authorized service personnel. In case of defects, please make a detailed description of the defect(s) and contact your supplier. Do not use a defective instrument. Note 3: Keep the HI-PRO USB away from liquids. Do not allow moisture inside the instrument. Note 4: Do not use the instrument in the presence of flammable anesthetics (gases). Note 5: It the HI-PRO USB unit is exposed to a strong radio field, it may interfere with the process of fitting a hearing instrument. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of the HI-PRO USB is restricted as much as possible. Note 6: No parts may be eaten, burnt, or in any way used for purposes other than the fitting of hearing aids or similar devices. Note 7: For safety reasons, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system.

5.3

Manufacturer

GN Otometrics A/S 2 Dybendalsvaenget, DK-2630 Taastrup, Denmark Phone: +45 4575 5555 Fax: +45 4575 5559 E-mail: [email protected] www.gnotometrics.com 5.3.1 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 authorised by the manufacturer.

•

The electrical installation to which the equipment is connected complies with EN/IEC requirements.

•

The equipment is used in accordance with the instructions for use. 12

HI-PRO USB Installation Guide

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.

13

HI-PRO USB Installation Guide

6

Technical Specifications

6.1

PC Interface

The serial USB (Universal Serial Bus) port is used for communication between a PC and the HI-PRO USB unit. Communication:

SB 2.0 full Speed (USB 1.1 compatible)

USB Connector Type:

"Type B" connector (on the HI-PRO USB unit)

6.2

Power Supply

The HI-PRO USB unit is powered from the PC USB port. Rated Voltage:

4.50V - 5.25V

Maximum Current Consumption (active):

< 500 mA (2.5 W)

Power Consumption during USB Suspend:

< 500 µA (2.5 mW)

6.3

Output ratings

The following output ratings are valid for Left and Right hearing instrument connectors Fixed Battery supply (pin1), common for Left and Right side

1.35V, 10/50 mA (current rating is controlled by fitting software)

Programmable battery supply (pin5), common for Left and Right side

-3.50 V to +3.50 V, 30 mA (voltage is controlled by fitting software)

6.4

Type identification

HI-PRO USB is type 1072 from GN Otometrics A/S.

6.5

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

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HI-PRO USB Installation Guide

Operation at temperatures below -20°C or above +60°C may cause permanent damage.

6.6

Storing and handling

Temperature:

-25°C to +70°C (-13°F to +158°F)

Rel. humidity:

< 90 %, non-condensing

Air pressure:

500 hPa to 1060 hPa

6.7

Dimensions and Weight

Size (L x W x H):

137 mm x 114 mm x 37 mm (5.39" x 4.49" x 1.46")

Net weight:

230g (0.43 lb)

6.8

Patient Safety

The HI-PRO USB unit complies with the following standards: •

EN 60601-1, Type BF

•

UL60601 and CAN/CSA-C22.2 NO 601.1-90

To comply with the above standards, the programming cable and the connector to the hearing instrument must meet the following requirements: •

No conductive parts may be accessible when the programming cable is connected to HI-PRO USB unit.

•

The programming cable and the connector must provide double isolation and be able to withstand a dielectric strength test potential of 500 V.

6.9

Product Lifetime

The estimated lifetime of the HI-PRO USB unit is 5 years.

6.10 Standards Safety:

EN 60601-1, Type BF

Electromagnetic compatibility:

EN 60601-1-2

Systems:

EN 60601-1-1

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HI-PRO USB Installation Guide

Hearing Instrument Interface

EN 60118-14

Notes on EMC (Electromagnetic Compatibility) • The HI-PRO USB is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely. •

Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of the HI-PRO USB . Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems The HI-PRO USB is intended for use in the electromagnetic environment specified below. The user of the HIPRO USB should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment -guidance

RF emissions CISPR 11

Group 1

The HI-PRO USB uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The HI-PRO USB is suitable for use in all environments, including domestic environments and those directly connected to public low-voltage power supply networks that supplies buildings used for domestic purposes

Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems The HI-PRO USB is intended for use in the electromagnetic environment specified below. The user of the HIPRO USB should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD)

+/- 6 kV contact

+/- 6 kV contact

IEC 61000-4-2

+/- 8 kV air

+/- 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

IEC 61000-4-8

Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

Note: UT is THE A:C: Mains voltage prior to application of the test level.

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HI-PRO USB Installation Guide

Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are not LIFE_SUPPORTING The HI-PRO USB is intended for use in the electromagnetic environment specified below. The user of the HIPRO USB should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Radiated RF IEC 61000-4-3

150 kHz to 80 MHz outside ISM bands a

Compliance level 3 V/m

3 V/m 80 MHz to 2,5 GHz

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the HI-PRO USB, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1,2 d = 1,2

for 80 MHz to 800 MHz

d = 2,3

for 80 MHz to 2,5 GHz,

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, c should be less than the compliance level in each frequency range. d Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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HI-PRO USB Installation Guide

a. b.

c.

d.

The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The compliance levels in the SMI frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HI-PRO USB is used exceeds the applicable RF compliance level above, the HI-PRO USB should be observed to verify normal operation. If abnormal performance is observed, additional measures might be necessary, such as reorienting or relocating the HI-PRO USB. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the HI-PRO USB Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz outside ISM bands

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = 1,2

d = 2,3

d = 1,2 0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equitation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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 absorption and reflection from structures, objects and people.

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HI-PRO USB Guide d'installation

86