natus otometrics HI-PRO 2 Installation Manual

HI-PRO2

Installation Manual

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

Part No. 7-50-09800-EN

Copyrightnotice

© 2015,2019Natus MedicalDe nmark ApS. Allrights reserved. ®
Otometrics, the OtometricsIcon, AURICAL,MADSEN, Otoscan,
ICSand HORTMANN are registered trademarks of Natus Medical
Denmark ApSin the U.S.A. and/or other countries.

Version release date

2019-02-05 (206837)

Technical support

Please contactyour supplier.

2 Otometrics - HI-PRO2

Table of Contents

1 Introduction to HI-PRO2

2 When you receive HI-PRO2

3 Installation

4 Service and Maintenance

5 Technical Specifications

6 Safety

7 Manufacturer

4

5

6

9

10

18

20

Otometrics - HI-PRO2 3

1 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 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2.

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 software for programming the hearing instrument (Fitting Software) and the
cables 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
health care professionals.

The intended use is to make the necessary adjustments to programmable hearing
instruments connected to the HI-PRO2 unit.

1.2 About this manual

This manual is your guide to installing and using HI-PRO2. We strongly recommend
that you read this manual carefully before using HI-PRO2 for the first time.

The manual contains a description of the main functions of HI-PRO2. Otometrics
recommends that you make yourself familiar with the following issues in particular:

• When you receive HI-PRO2 ► 5

• Installation ► 6

• Safety ► 18

1.2.1 Safety

This manual contains information which must be followed to ensure the safe per­formance of HI-PRO2. Local government rules and regulations, if applicable, should

4 Otometrics - 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 ► 18.

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

patient.

Caution• Indicates that there is a risk of injury to the user or patient 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 HI-PRO2, it is a good idea to keep the packing material in
which it was delivered. If you need to send the HI-PRO2 in for service, the ori­ginal packing material will protect against damage during transport, etc.

2. Visually inspect the equipment for damage. If damage has occurred, do not put
the HI-PRO2 into operation. Contact your supplier for assistance.

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

– HI-PRO2 unit

– USB interface cable

– Software Installation CD

– Installation Guide

Otometrics - HI-PRO2 5

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

2.2 HI-PRO2 front and rear view

HI-PRO2 front view

HI-PRO2 rear view

2.3 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.

• Store HI-PRO2 as stated in Technical Specifications

3 Installation

• Site the HI-PRO2 unit in a well-ventilated location away from all liquids and
sources of heat.

• An installation CD is provided with HI-PRO2. Before you connect HI-PRO2 to
the PC, this software must be installed.

6 Otometrics - HI-PRO2

3.1 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.

• 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2 to the PC

Note•An installation CD is provided with HI-PRO2. Before you connect HI-

PRO2 to the PC, this software must be installed.

• Connect the USB connector on the rear of HI-PRO2 to a USB port of a personal
computer (PC) by means of the supplied USB cable. See Fig. 1.

Fig. 1

Otometrics - HI-PRO2 7

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.

3.3 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.

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2 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 act-

ive, and this might damage the hearing instrument.

Caution• Even though the hearing instrument connectors on the front of the

HI-PRO2 are galvanically insulated from the PC and mains earth, it is still pos-

sible to release an electrostatic discharge (ESD) to a connected hearing instru-

ment, and through the HI-PRO2 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 hear-

ing instruments have been reported. It is recommended to install the unit in

an environment that minimizes the amount of static electricity. For example,

anti-static carpeting is recommended.

3.4 Disconnecting HI-PRO2 from the PC

HI-PRO2 automatically powers off together with the PC, but if you wish to power
off the HI-PRO without powering off the PC, you can disconnect the USB cable from

8 Otometrics - HI-PRO2

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.

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2 from the PC, and make sure that it can-

not be used by others until it has been serviced.

Warning • Under no 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 electric shock.

There are no user-serviceable parts inside the HI-PRO2 device cabinet. For the

sake of safety and in order not to void the warranty, service and repair of elec-

tro-medical equipment should be carried out only by the equipment man-

ufacturer or by service personnel at authorized workshops. In case of any

defects, make a detailed description of the defect(s) and contact your supplier.

Do not use a defective device.

Following repair, the equipment should be tested by suitably qualified per-

sonnel.

Otometrics - HI-PRO2 9

4.2 Maintenance

HI-PRO2 requires no preventive maintenance. However, it is recommended that
you observe the guidelines below.

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

5 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.

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2 unit is powered from the PC USB port.

Rated Voltage 4.50V - 5.25V

Maximum Current Con­sumption (active)

Power Consumption during
USB Suspend

< 500 mA (2.5 W)

< 500 µA (2.5 mW)

Operating system

Windws XPPro SP3, Windows 7b (32 and 64 bit),Windows 8 (32 and 64
bit),Windows 10

Product Lifetime

The estimated lifetime of the HI-PRO2 unit is 5 years.

10 Otometrics - HI-PRO2

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

EMC 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
Interface

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2 unit.

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

IEC 60118-14:1998
EN 60118-14:1998

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

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

Otometrics - HI-PRO2 11

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

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

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. humidity < 90 %, non-condensing

Air pressure 500 hPa to 1060 hPa

Dimensions and Weight

Size (L x W x H) 137 mm x 114 mm x 37 mm

Net weight 230g (0.43 lb)

5.1 Accessories

(5.39 inch x 4.49 inch x 1.46 inch)

Item Part number

1072 HI-PRO 2, Installation CD 8-49-91200

USB Cable, 3 meters 8-71-79100

USB Cable, 2 meters 8-71-79200

USB Cable, 1 meter 8-71-86500

HI-PRO 2 User Guide 7-50-09800-XX

5.2 Notes on EMC (Electromagnetic Compatibility)

• HI-PRO2 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.

12 Otometrics - HI-PRO2

• 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'sdeclaration - 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2shou ld

ensurethat it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Guidance and manufacturer'sdeclaration - electromagnetic immunity for all equipment and systems

HI-PRO2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO2shou ld

ensurethat it is used in such an environment.

Immunitytest IEC 60601

Electrostatic discharge

(ESD)

IEC 61000-4-2

Electricalf ast tran-

sient/burst IEC 61000-

4-4

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

Group 1 HI-PRO2 usesRF energy only for its internal fun ction. Therefore, itsR F

emissions arevery low and are not likely to c auseany interference in

nearby electronic equipment.

ClassB HI-PRO2 is suitable for usein all environments, including domestic

environments and th osed irectly connected to the pu blic low-voltage

power supply network that supplies buildings used fo r domestic pur-

poses.

Compliance level Electromagnetic environment - guid-

test level

+/- 8 kV contact

+/- 2 kV, +/- 4 kV,

+/- 8 kV, +/- 15 kV air

+/- 1 kV for inp ut/out-

put lines

30A/m No relevant po rts

+/- 8 kV contact

+/- 2 kV, +/- 4 kV,

+/- 8 kV, +/- 15 kV air

No relevant p orts

that co uld be

affected

that co uld be

affected

ance

Floors should be wood, concrete or

ceramic tile.If floors are covered with

synthetic material, the relative humid-

ity should be at least 30%.

Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical com-

mercialor hospital environment.

Otometrics - HI-PRO2 13

Guidance and manufacturer'sdeclaration - electromagnetic immunity - f or equipment and systemswithin

Professional Healthcareuse environment

HI-PRO2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO2

should ensure that it isu sed in such an environment.

Immunitytest IEC 60601

test level

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

Proximityfields from

RF wirelessco m-

munications

IEC 61000-4-3

3 V rms

150 kHzto 80MHz

6 V rms

ISM

BandsandAmateur

10V/m

80MHz to 2.7GHz

27V/m

386 MHz

28v/m

450 MHz,

9 v/m

710 MHz, 745MHz, 780

MHz

28v/m

810 MHz, 870MHz, 930

MHz,

28v/m

1720MHz, 1845MHz,

1970MHz

28v/m

2450MHz,

9 v/m

5240MHz, 5500MHz,

5785MHz

Compliance level Electromagnetic environment -

guidance

3 V rms

150 kHzto 80MHz

6 V rms

ISM

BandsandAmateur

10V/m

80MHz to 2.7GHz

27V/m

386 MHz

28v/m

450 MHz,

9 v/m

710 MHz, 745MHz, 780

MHz

28v/m

810 MHz, 870MHz, 930

MHz,

28v/m

1720MHz, 1845MHz,

1970MHz

28v/m

2450MHz,

9 v/m

5240MHz, 5500MHz,

5785MHz

Separation d istance between any

electronic partsof HI-PRO2and

any RF wirelessco mmunication

equipment must be mo rethan 30

cm (11.8 inches).

Note:These guidelinesmay n ot

apply in all situations.Elec-

tromagnetic propagation is

affected by absorption and reflec-

tion from structures,objects and

people.

14 Otometrics - HI-PRO2

IEC 60601-1-2:2007 and EN 60601-1-2:2007

Guidance and manufacturer'sdeclaration - 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2shou ld

ensurethat it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11 Group 1

RF emissions

CISPR 11 ClassB

Guidance and manufacturer'sdeclaration - electromagnetic immunity for all equipment and systems

HI-PRO2 is intended for use in the electromagnetic environment specified below. The user of HI-PRO2shou ld

ensurethat it is used in such an environment.

Immunitytest IEC 60601

test level

Electrostatic discharge

(ESD)

IEC 61000-4-2

Electricalf ast tran-

sient/burst IEC 61000-

4-4

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

+/- 6 kV contact

+/- 8 kV air

+/- 1 kV for inp ut/out-

put lines

3 A/m 3 A/m Power frequency magnetic fields

HI-PRO2 usesRF energy only for its internal fun ction. Therefore, itsR F

emissions arevery low and are not likely to c auseany interference in

nearby electronic equipment.

HI-PRO2 is suitable for usein all environments, including domestic

environments and th osed irectly connected to the pu blic low-voltage

power supply network that supplies buildings used fo r domestic pur-

poses.

Compliance level Electromagnetic environment - guid-

ance

+/- 6 kV contact

+/- 8 kV air

No relevant p orts

that co uld be

affected

Floors should be wood, concrete or

ceramic tile.If floors are covered with

synthetic material, the relative humid-

ity should be at least 30%.

should be at levels characteristic of a

typical location in a typical com-

mercialor hospital environment.

Otometrics - HI-PRO2 15

Guidance and manufacturer'sdeclaration - electromagnetic immunity - f or equipment and systemsthat 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 isu sed in such an environment.

Immunitytest IEC 60601

test level

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHzto 80MHz

3 V/m

80MHz to 2.5GHz

Compliance level Electromagnetic environment - guid-

ance

3 Vrms

150 kHzto 80MHz

Portableand mobile RF com-

munications equ ipment should be

used no closer to any p art of HI-

PRO2, includ ing cables,than the

recommended separation d istance cal-

culated from the equation applicable

to th e frequency of the transmitter.

Recommended separation distance:

d = 1.2

d = 1.2 for 80 MHzto 800 MHz

d = 2.3 for 80 MHzto 2.5 GHz,

3 V/m

whereP is the maximum ou tput

power rating of the transmitter in

watts(W) accord ing to th e trans-

mitter manufacturer and d is the

recommended separation d istance in

metres (m).

Field strengths from fixed RF trans-

mitters, asd etermined by an elec-

tromagnetic sitesurvey,ashould be

less than the compliance level in each

frequency range.

b

Interference may occu r in th e vicinity

of equipment marked with this sym-

bol:

16 Otometrics - HI-PRO2

Guidance and manufacturer'sdeclaration - electromagnetic immunity - f or equipment and systemsthat are

NOT life-supporting

Note 1: At 80 MHz and 800MHz the separation distance for the higher frequency rangeapplies.

Note 2: These guidelinesmay not app ly in all situations. Electromagnetic prop agation is affected b y absorp-

tion and reflection fro m structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephonesand

land mobile radios,amateur radio, AM and FM radio broadc ast and TV broadcast cannot be predicted

theoretically with accuracy. To assess the electromagnetic environment du e to fixed RF transmitters,an

electromagnetic sitesurvey should be co nsidered. If the measured field strength in th e location in which

HI-PRO2 is used exceeds the applicable RF compliance level above, the HI-PRO2 should be observed to

verify normal op eration. If abn ormal performance is observed, addition al measuresmight be necessary,

such as reorienting or relocating HI-PRO2.

b. Over the frequency range 150kHz to 80 MHz,field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF co mmunications equipment and HI-

PRO2

Rated maximum output

power of transmitter

W

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 po wer not listed above, the recommended separation distance d

in meters(m) can be estimated using the equation applicable to the frequency o f the transmitter,where P is

the maximum o utput power rating of th e transmitter in watts (W) according to the transmitter manufacturer.

Separation d istance according to frequency o f transmitter

m

150 kHzto 80MHz

d = 1.2

80MHz to 800MHz

d = 1.2

800 MHzto 2.5GHz

d = 2.3

Note 1: At 80 MHz and 800MHz the separation distance for the higher frequency rangeapplies.

Note 2: These guidelinesmay not app ly in all situations. Electromagnetic prop agation is affected b y absorption

and reflection from structures, objects and people.

Otometrics - HI-PRO2 17

6 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 applic­able, should also be followed at all times.

6.1 HI-PRO2 symbols

Complies with Type BF requirements of IEC 60601­1:2005+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 Directive (2011/65/EC).

Complies with Medical Devices Directive 93/42/EEC and
RoHS Directive (2011/65/EC).(For accessories only)

Manufacturer.

Serial number

Catalog/product number

Authorized representative in the European Community. (If
applicable for accessories only)

18 Otometrics - HI-PRO2

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 accu­mulators 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 stand­ards, 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 require­ments of IEC 60601-1:2005+AMD1:2012 and EN 60601­1:2006+A1:2013.

1. The HI-PRO2 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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 60601­1:2005+AMD1:2012 and EN 60601-1:2006+A1:2013 when the PC, printer, etc.

Otometrics - HI-PRO2 19

are placed out of reach of the patient, i.e. not closer than approx. 1.5 meters/5
ft.

2. Keep the HI-PRO2 away from liquids. Do not allow moisture inside the instru­ment.

3. Do not use the instrument in the presence of flammable anesthetics (gases).

4. If the HI-PRO2 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2 is restricted as much as possible.

5. The HI-PRO2's RF emissions are very low and are not likely to cause any inter­ference in nearby electronic equipment, but negative effect or loss of func­tionality of other local devices may occur if they are placed in close vicinity of
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 to the
equipment's outlet fittings must be identical to the type supplied with the sys­tem.

8. Do not store or operate the device at temperatures and humidity exceeding
those stated in the Technical Specifications. See Technical Specifications

9. We recommend that the device should not be stacked with other equipment
or placed in a poorly ventilated space as this may affect the performance of the
device. If it is stacked or placed adjacent to other equipment, make sure that
the operation of the device is not affected.

10. Accidental damage and incorrect handling can have a negative effect on the
functionality of the device. Contact your supplier for advice.

7 Manufacturer

Natus Medical Denmark ApS
Hoerskaetten 9, 2630 Taastrup
Denmark

[phone]

www.otometrics.com

20 Otometrics - HI-PRO2

7.1 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 authorized 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.

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

Otometrics - HI-PRO2 21