Heidelberg HEP Installation manual

Heidelberg Edge Perimeter

Installation and
System Configuration

Version 002, November 2010

© Heidelberg Engineering GmbH 2010

Art. No. 90922

QM-No. 97 251-002

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The manufacturer hereby declares that this product conforms to the requirements

0482

of Directive 93/42/EEC of the Council of the European Community dated 14 June
1993 regarding medical products (MDD 93/42/EEC).

Corporate Headquarters

Heidelberg Engineering GmbH • Tiergartenstr. 15 • 69121 Heidelberg • Germany

Phone [phone] • Fax [phone] • www.HeidelbergEngineering.de

US Main Office

Heidelberg Engineering, Inc. • 1499 Poinsettia Avenue, Suite 160 • Vista, CA 92081

Phone [phone] • Fax [phone] • www.HeidelbergEngineering.com

US Service Center

Heidelberg Engineering, Inc. • 410 Harris Road • Smithfield, RI 02917

Phone [phone] • Fax [phone] • www.HeidelbergEngineering.com

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Table of Contents

Table of Contents

Table of ContentsTable of Contents

1111 GENERAL INFORMATION

GENERAL INFORMATION................................

GENERAL INFORMATIONGENERAL INFORMATION

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................................................................

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................................................................

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................................ 4444

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1.1 T

1.2 T

1.3 R

1.4 T

1.5 S

1.6 M

2222 HARDWARE INSTALLATIO

2.1 U

2.2 I

2.3 S

2.4 P

2.5 T

3333 OOOOPERATING SOFTWARE IN

3.1 O

4444 INSTALLATION INSTRUC

HE MEDICAL DEVICE

HE

HEP S

YSTEM

EGULATORY STANDARDS

HIRD PARTY HARDWARE AND SOFTWARE

AFETY INFORMATION, CAUTIONS AND WARNINGS

AINTENANCE

HARDWARE INSTALLATIONNNN ................................

HARDWARE INSTALLATIOHARDWARE INSTALLATIO

NPACKING THE

NSTALLING THE EXTERNAL

ETTING UP CABLE CONNECTIONS

OWER-UP SEQUENCE

RANSPORTATION INSTRUCTIONS

PERATING SOFTWARE INSTALLATION

PERATING SOFTWARE INPERATING SOFTWARE IN

PERATING SOFTWARE - UPDATE

INSTALLATION INSTRUCTIONS FOR SHARING DA

INSTALLATION INSTRUCINSTALLATION INSTRUC

HEP........................................................................................................................................4

..........................................................................................................................................................5

...........................................................................................................................................5

.............................................................................................................5

..............................................................................................................................................................8

................................................................

................................................................

HEP...................................................................................................................................................9

TFT M

ONITOR

......................................................................................................................... 12

:............................................................................................................................................... 13

:.......................................................................................................................... 13

STALLATION ................................

STALLATIONSTALLATION

........................................................................................................................... 14

TIONS FOR SHARING DATABASES BETWEEN

TIONS FOR SHARING DATIONS FOR SHARING DA

.......................................................................................................... 11

.............................................................................................7

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TABASES BETWEEN HRT AND HEP

TABASES BETWEEN TABASES BETWEEN

..........................................................

................................................................

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HRT AND HEP.......

HRT AND HEPHRT AND HEP

..........................9999

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................................ 14

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14

1414

....... 17

17

..............

1717

4

17” monitor

Lens cover

Chin rest

Lens

Eye occluder

1 General Information

1.1 The Medical Device HEP

The Heidelberg Edge Perimeter (HEP) is designed to provide comprehensive functional testing of the
visual system. It employs traditional visual field measurement techniques such as Standard Automated
Perimetry (SAP), along with a unique new visual function-specific stimulus called Flicker-Defined
Form (FDF). This enables full scope perimetric evaluation of patients with retinal, optic nerve and
neurological defects. The FDF stimulus is specifically designed for the early detection of glaucomatous
visual field changes.
Standard Automated Perimetry (SAP) may be considered more suitable for the detection and
monitoring of neurological defects, moderate to severe glaucoma and other conditions associated with
extensive and deep visual field loss, such as ischemic optic neuropathy.

Head rest

Keyboard

Patient Response
Button

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1.2 The HEP System

The HEP can work alone as a stand-alone perimeter or in combination with the Heidelberg Retina
Tomograph (Model HRT 2 or 3 with software version 3.1 or higher) for a comprehensive glaucoma
analysis of structure and function.

The HEP alone and together with other connected devices constitutes a medical electrical system (“ME
system”) according to IEC 60601-1-1. This system must meet specific safety criteria as detailed in the
standard and in this document. Note that every connected device will become part of the ME-System even if the

only connection is the power supply cord leading to a shared multiple socket outlet.

WARNING

For setting up a safe system it is essential to read and understand the below section Safety
Information.

The ME system may only be assembled by qualified personnel with training and

knowledge in electrical safety, heeding all instructions and safety warnings contained
in this document. It is especially important that all users that de-install and reinstall
the system (for example in a mobile use scheme) are trained to do this in a safe way.

1.3 Regulatory Standards

The HEP complies with the international IEC 60601 standard series concerning medical electrical
equipment. These standards are published by the International Electrotechnical Commission and are
the base of most national and regional standards for medical electrical equipment worldwide.

Some local standards contain deviations from the IEC versions. These standards include UL 60601-1
(USA), CAN/CSA C22.2 No. 601.1 (Canada), JIS T 0601-1 (Japan), AS 3200.1.0. (Australia) and others.

Wherever IEC 60601-Standards are mentioned inside this document, the according regulations of respective local
standards are also implied.

NOTICE

Even though the HEP already conforms to most local standards for medical devices in

its default configuration, actual conformance can only be ensured by buying it from an
authorized local Heidelberg Engineering distributor.

1.4 Third Party Hardware and Software

1.4.1 Isolation Transformer

HEP device, TFT monitor and all mains supplied accessories need to be supplied through an isolation
transformer:

• Noratel Germany AG, model: IMEDi 300WR (300 VA) or

• DeMeTec, Germany, type IPS (330 VA)

Make sure that the total power consumption does not exceed the specified electrical power output for
each individual isolation transformer as indicated above.

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1.4.2 Printers

The HEP device can be operated with any standard inkjet printer.

To ensure safe operation, please note that they must have CE and/or FCC approval.

1.4.3 External Devices

The HEP device can be operated with the following external devices:

• USB hub

• USB storage device

• External DVD-RAM drive

To ensure safe operation, please note:

• USB hub and storage device must have CE and/or FCC approval.

• USB hub and storage device must be powered from USB port only.

1.4.4 Anti-virus Software

Use the HEP device exclusively with AVG antivirus software. Other antivirus software may interfere
with FDF stimulus presentation.

When installing the antivirus software per manufacturer’s recommendation, configure it so it does not
scan automatically. Otherwise it may interrupt the operation of the device.

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1.5 Safety Information, Cautions and Warnings

This section contains important safety information. Please read it carefully!

1.5.1 General Safety Information

IMPORTANT Before you start working with the instrument, make sure that you know the correct

procedures for turning the instrument on and off (see HEP Operation Instructions).

IMPORTANT Carefully read the instructions for use before operating the device. Misuse of the device

may lead to hazards for the patient or the operator or can lead to wrong diagnostic
results. Use outside the “intended use” scope may also lead to instrument damage.

The instrument must not be used if there is a mechanical, electrical, or optical defect. Modifications or
additions lead to loss of conformity. Heidelberg Engineering does not take responsibility for modified
HEP devices.

Any repair, especially of the instrument's electric and electronic systems, and any service work on the
instrument components, must only be carried out by Heidelberg Engineering or an authorized
distributor.

1.5.2 Warnings and Cautions

WARNING

To avoid the risk of electric shock, the system must be installed in accordance to IEC

60601-1-1 or the corresponding local standard particularly with regard to the electrical
leakage currents. Every modification to the system requires a new evaluation of the
requirements of said standard.

WARNING

If your system configuration includes a multiple socket outlet, do not place it on the

floor as this entails the risk of liquid ingress or accidental mechanical damage.

WARNING

Do not connect an additional multiple socket outlet or an extension cable to the

system. This would lead to increased protective earth impedance and therefore to an
increased risk of electric shock.

WARNING

Do not connect additional devices to the system that are not part of the system or not

specified as compatible to the system.

WARNING

Do not use multiple socket outlets that are part of the HEP system for other devices

that are not part of the system (e.g. office equipment, domestic appliances). This would
lead to increased electrical leakage currents and therefore to an increased risk of
electric shock for both patient and operator.

WARNING

Devices intended to be used together with a separating transformer (or ‘isolating

transformer’) may not be used without that transformer. A bypass of the separating

transformer may lead to excessive electrical leakage currents and therefore to an
increased risk of electric shock.

WARNING

Do not touch the patient and parts inside access covers or contacts of connectors of

nonmedical devices simultaneously.

WARNING

Carry out all cleaning, adjustment, sterilization and disinfection procedures as

specified in the enclosed instructions for use of the particular system components.