Planar invitium Operation Manual

OPERATIONS MANUAL

Invitium™Medical
Workstation

OPERATIONS MANUAL

© Copyright, 2002, Planar Systems, Inc.

Please address any questions, comments, and suggestions to:

Planar Systems, Inc.

1400 N.W. Compton Drive
Beaverton, OR 97006 USA
Phone: [phone]
[phone]
Fax: [phone]

Planar Systems, Inc.

Olarinluoma 9
P. O . B o x 46
FIN-02201 Espoo, Finland
Phone: [phone]
Fax: [phone]
http://www.planar.com

The information in this document is subject to change without notice.This publication may not be reproduced, stored in a retrieval system, or
transmitted by any means without prior written permission of Planar Systems,Inc.

Invitium is a trademark and Planar is a registered trademark of Planar Systems, Inc. IBM is a registered trademark of International Business
Machines Corporation.Windows and MS-DOS are registered trademarks of Microsoft Corporation. Intel, Pentium, and Celeron are registered
trademarks of Intel Corporation. All other trademarks and trade names are the property of their respective companies.

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Medical Workstation OPERATIONS MANUAL

Invitium™Medical Workstation Operations Manual

About this manual

This manual is intended to assist you in setting up and using your new Invitium™Medical
Workstation.This information has been carefully checked for accuracy; however, no guarantee
is given to the correctness of the contents.The information in this manual is subject to change
without notice.This manual contains proprietary information protected by copyright.All rights
are reserved. No part of this manual may be reproduced by any mechanical, electronic or other
means, in any form, without prior written permission of the manufacturer.

This manual includes the following sections:

Section 1 About the Invitium Medical Workstation, explaining its features and key specifica-

tions.

Section 2 Getting Started, includes instructions on mounting the Invitium workstation and

connecting its modules, making display adjustments and calibrating the optional
touchscreen.

Section 3 Invitium System Setup, helps you define hardware and software options in the

system’s BIOS utility.

Section 4 Troubleshooting the Invitium Medical Workstation, provides guidance in

identifying potential problems you could encounter.This section also has instruc­tions for reinstalling Windows® and several device drivers

Section 5 Invitium Medical Workstation Technical Specifications, provides extensive system

details provided for your reference.

We encourage you to look through the entire Operations Manual to familiarize yourself with
its contents before you begin to set up or use your Invitium Medical Workstation.

INTRODUCTION

Introduction iii

Regulatory Information

U.S. Federal Communications Commission (FCC) Requirements

The Planar Invitium™Medical Workstation has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.These limits are designed to
provide reasonable protection against harmful interference in a residential installation.This
equipment generates, uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which can be deter­mined by turning the equipment off and on, the user is encouraged to try to correct the inter­ference by one or more of the following measures.

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and the receiver.

• Connect the equipment to an outlet different from that to which the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for help.

To comply with the limits for an FCC Class B computing device, always use the shielded signal
cord supplied with this unit. The Federal Communications Commission warns that changes or
modification of the unit not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.

Canadian Doc Notice

For Class B Computing Devices

This digital apparatus does not exceed the Class B limits for radio noise emissions from digital
apparatus as set out in the Radio Interference Regulation of the Canadian Department of
Communications.

“Le present appareil numerique n’emer pas de bruits radioelecinques depassant les limires
applicables aux appareils numeriques de la class B prescrites dans le Reglement sure le brouiliage
radioelectrique edicte par le minstere des Communications du Canada”

Regulatory Compliance

This system has been tested and found to comply with IEC/EN 60601-1, IEC/EN 60601-1-2,
UL 2601-1 and CAN/CA C22.2 No. 601.1 medical standards by Underwriters Laboratories, Inc.

Because many medical offices are located in residential areas, the Invitium workstation, in addi­tion to meeting medical requirements, has also been tested and found to comply with the limits
for Federal Communications Commission (FCC) Class B computing devices in a typically con­figured system. It is the system integrator or configurer’s responsibility to test and ensure that
the entire system complies with applicable electromagnetic compatibility (EMC) laws. Planar
Systems, Inc. has made great efforts to support the medical device industry, in particular medical
device manufacturers and medical device system integrators.We offer state-of-the-art systems
that are compliant with worldwide accepted medical device safety standards, and for the

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Medical Workstation OPERATIONS MANUAL

European market, EC-marked displays based on compliance with counsel directive 93/42/EEC
— commonly referred to as the Medical Device Directive (MDD).The following summarizes
our qualification of these displays as it relates to compliance with the MDD.

The European MDD requires that the intended use of the device be defined.The intended use
of the Invitium workstation is “to display alphanumeric, graphic, and image data as inputted
from any type of medical device.”This system does not provide a measurement function in any
way, and it is the device and systems manufacturers responsibility to verify its function in the
integrated device or system.The workstation was classified as required by the MDD according
to Annex IX of the directive and the medical device (MEDDEV) guidance available at the time
of classification.

Because the workstation uses electrical energy and has no direct patient connections and- — by
itself — no medical utility, the workstation is classified according to Rule 12 as an MDD Class I
device-component or accessory.

The MDD states that manufacturers of Class I medical devices or accessories shall satisfy the
requirements in regard to design and manufacturing controls; i.e., the applicable assessment
route to be used for CD-marking under the MDD, and it shall carry the CD-mark according to
Annex XII for the directive, with no notified body annotation.

The applicable safety standards for an MDD Class I device are IEC/EN60601-1: 1990 along
with Amendments 1 and 2.To help the medical device designer evaluate the suitability of these
workstations, Planar has also conducted EMC testing to IEC 60601-1-2 as it can be applied.
The display with its power supply alone does not represent a functional medical device. Hence,
Planar configured a minimal operating system to exercise the display.The resulting data is made
available to interested parties.

The data is informative data, not certification data. Certification data must be obtained by the
device or system integrator according to Article 12 of the MDD titled “Particular procedure for
systems and procedure packs.” Paragraph 2 clearly outlines the device or system integrator’s
responsibility in this matter.

In summary, Planar Systems, Inc. is CE-marking theses workstations under the Medical Device
Directive, which establishes compliance to the basic medical safety standards. However, EMC
compliance can only be accomplished in the configured medical device or system and is the
responsibility of the device or system manufacturer. Planar has the necessary documentation
such as IEC 60601-1 notified body and other third-party test reports and certifications, a
risk/hazard analysis, and essential requirements checklist, and Planar’s International
Electrotechnical Commission (IEC) declaration of conformity.

Planar Systems, Inc. located in Beaverton, OR, USA is the manufacturer of these workstations
in the meaning of the directive.As required by the MDD in Article 14, Planar Systems, Inc. not
residing in the European Economic Area (EEA) has a European Representative, Planar Systems,
Inc. –Espoo, Finland.

In the opinion of Planar Systems, Inc. registration required to put its device into commerce is
the responsibility of the medical device/system manufacturer, and Planar supports this require­ment by providing a European Commission (EC) declaration of conformity. If Planar supplies a
workstation to an end user, rather than a device manufacturer, it is the end user’s responsibility
to ensure continued compliance with the MDD of the system in which the workstation is inte-

Introduction v

grated. For vigilance reporting as required under Article 10 of the MDD, Planar Systems, Inc.
will provide any information requested by competent authority to support any reported inci­dent investigation by such an authority.

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Invitium system is intended for use in the electromagnetic environment specified below. The
customer or the user of the Invitium System should assure that it is used in such an environment.

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT — GUIDANCE

RF emissions The Invitium System uses RF energy only for its
CISPR 11

Group 1

internal function.Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.

RF emissions

Class B

CISPR 11
Harmonic emissions

Class A

IEC 61000-3­Voltage fluctuations/

Flicker emissions Complies
IEC 61000-3-3

The Invitium System is suitable for use in all estab­lishments, including domestic establishments and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.