Heidelberg SL-OCT User manual

SL-OCT

Slitlamp- OCT
Installation Instructions

Version 001, February 2009
© Heidelberg Engineering GmbH 2009
Art. No 18107
QM-Nr. 97 201-001

SL-OCT Installation Manual

Art. No.: 18107 Page 2 of 42

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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Contents

1 INTRODUCTION 4
2 SCOPE 6
3 TOOLS 7
4 UNPACKING THE SYSTEM 8

4.1 Lift table 8

4.2 OCT-box 8

4.3 Slit lamp 8

5 INSTALLATION 9

5.1 Lift table 9

5.2 Optional printer table 16

5.3 OCT-box 19

5.4 Slit lamp 25

5.5 Electrical and fiber connections to the slit lamp 26

5.6 Electrical connections to the OCT-box 28

5.7 AC connections 29

5.8 Cleaning 30

6 TEST MEASUREMENT 31
7 DISASSEMBLY OF A SL-OCT UNIT 33
8 APPENDIX A: TROUBLESHOOTING 35
9 APPENDIX B: LIST OF SCREWS 37
10 APPENDIX C: PACKING LISTS 38

10.1 Lift table 38

10.2 OCT-box 39

10.3 Slit lamp 40

10.4 Optional printer table 42

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1 Introduction

The SL-OCT is a tomographic device for the viewing and axial, cross sectional imaging of anterior ocular
structures. It is used for the in vivo imaging and measurement of the anterior segment structures of the
eye.
This document describes the installation of the SL-OCT device. It also contains important safety
information.

NOTE: To ensure the overall safety of the system, the SL-OCT must be installed by certified staff

of your local Heidelberg Engineering distributor.

Scanner-box

Slit lamp

Printer table
(optional)

Lift table

OCT-box

Pic. 1 SL-OCT with optional printer table

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1.4 Cautions, Warnings, and Contraindications
WARNING Carefully read the operation manual before operating the device. Misuse of the device

may lead to incorrect diagnostic results.

WARNING Do not open the device component housings. Doing so may result in electrical shock and

laser radiation.

WARNING Do not use the device outside the scope of its “Intended use”. Doing so may lead to

malfunctions or damage of the device.

WARNING Do not use PCs, components or accessories that have not been approved by Heidelberg

Engineering. Do not install other software as this may interfere with the functionality of the
Heidelberg Engineering software or equipment. This could include damage to the system
as well as incorrect measurement results.

WARNING Do not use a network connection without network isolation in accordance with

IEC 60601-1. In the event of a failure in the network, user and patient could be at risk of
electrical shock.

WARNING Make sure that the environmental requirements are met when the system is operated.

Exceeding environmental conditions may damage the system or lead to incorrect
measuring results.

WARNING Make sure the patient is correctly positioned in front of the device before starting the

examination. Wrong positioning may lead to poor images and incorrect diagnostic results.

WARNING Artifacts on the images could falsify the measured results. Do not use the measured

results for further treatment if there are artefacts in the images.

WARNING Do not make a diagnostic decision on the basis of one single examination. The device is

not clinically evaluated for the diagnosis of specific pathologies. So always use alternative
information; history data etc. to assist in a final diagnostic determination.

WARNING Do not use the analysis results from patients with pathological eyes without an inspection

of the segmentation. In case of pathological eyes, the segmentation might be incorrect,
and lead to wrong calculations of the analysis results.

WARNING Prepare safeguards to ensure that only authorized personnel can access the patient

data. Data loss impedes follow-up analyses and may result in inappropriate diagnostic
decisions.

WARNING Be sure to perform periodic data backup procedures. Check the success of the backup to

avoid data loss caused by backup errors.

WARNING To avoid the risk of electric shock, this equipment must only be connected to a grounded

power supply.

WARNING To avoid the risk of electric shock, do not touch conductive parts of connectors and the

patient simultaneously.

WARNING Do not operate the system directly after large temperature changes. Let the device

acclimatize itself for a minimum of 2 hours to avoid device damage or incorrect
measurement results.

CAUTION Never leave the patient alone with the instrument during the examination!
CAUTION The instrument must not be used under any circumstances if mechanical, optical or

electrical faults occur. Any change or addition to the system must comply with the
relevant legal guidelines. Repairs, particularly to the electronic and optical components,
must be carried out only by Heidelberg engineering authorized, trained personnel.

CAUTION Unusual noises and/or vibrations can indicate a fault. Should this happen, please turn the

instrument off immediately and contact the technical support center responsible for your
area. Do not attempt to repair the instrument yourself in the event of a fault.

CAUTION This instrument contains a diode laser and emits invisible laser light through the slit lamp.

The Heidelberg SL-OCT is a Class I laser system. The laser does not pose any safety
hazard.

CAUTION This equipment was tested in accordance to IEC 60601-1-2, Electromagnetic

Compatibility (EMC). Nevertheless, it might be affected by strong electromagnetic fields.
Portable high frequency communication devices may affect the device.

CAUTION The operator must be sure that the device settings and adjustments are correct before

starting an examination and making any diagnostic decision. Wrong settings and
adjustments may lead to poor image quality or incorrect examination information.

CAUTION The physician must be sure to have the correct patient data before making a diagnostic

decision. Mismatched patient data may lead to inappropriate diagnostic decisions.

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CAUTION Read subsection “Imaging Process” of the Operation Instructions carefully before starting

the examination. Incorrect preparation of the patient may lead to poor image quality and
incorrect diagnoses.

CAUTION Do not start an examination without informing the patient about the examination

procedure. Inappropriate patient behavior during the examination may lead to poor image
quality and incorrect diagnoses.

CAUTION Read subsection “Service Maintenance and Cleaning” of the Operation Instructions

carefully. A failure to carry out maintenance or incorrect adjustment of the device may
lead to poor image quality and incorrect diagnoses.

CAUTION Before starting the system check the regional power supply specifications to verify that

they comply with the required tolerances (100V < U < 240V; 50Hz < f < 60Hz). Wrong
power supply conditions may lead to malfunctions of the system.

CAUTION A computer failure during image acquisition or analysis could lead to incorrect results.
CAUTION United States of America:

Federal law restricts this device to sale by or on the order of a Physician or Practitioner.

CAUTION While printing using the optinal printer table, it is not possible to take measurements due

to the vibrations of the printer

CONTRAINDICATIONS No contraindications are known.

For the United States of America only:

The laser class label “Laser Class 1” is located on the rear of the OCT housing.
The Laser safety class is approved and defined in accordance to IEC 60825 part
1 and part 2 and in accordance to the 21 CFR Part 1040 “Performance Standard
for Light emitting Products”.

2 Scope

This installation instruction is referring to model SL-OCT Ver. B01.

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3 Tools

The following tools are required:

 Allen wrenches

o 5 mm
o 3 mm
o 2.5 mm

 Screwdriver for slotted head screws 3 mm
 Wire cutter
 Cutter.

For the assembly of the optional printer table, following
the tools are required:

 Allen wrench with ball head

5 mm

 Screwdriver for recessed head screws
 Wire cutter
 Long nose pliers
 Cutter.

Pic. 2 Tools for installation of SL-OCT

Pic. 3 Tools for the assembly of the printer table

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4 Unpacking the system

The SL-OCT is delivered in three cardboard boxes – lift table, OCT-box, and slit lamp. The packing lists
for each box are listed in section 10 Appendix C.

4.1 Lift table

The lift table package contains three layers:

1. Cable conduit, column, keyboard fixation
arm, and monitor fixation arm.

2. Cables, wheels, and table top.

3. Foot.

Pic. 4 Cardboard box containing the lift table

4.2 OCT-box

The OCT-box package contains two layers:

1. Folder with operating instructions etc., and
mouse pad.

2. Cables, mouse, dust cover, protective caps,
replacement fuses, OCT-box.

4.3 Slit lamp

The slit lamp package contains two layers:

1. Head rest in a separate cardboard box.

2. Monitor, slit lamp with permanently mounted
scanner-box, slit lamp accessories in a
separate cardboard box, eyepieces for the
microscope, and keyboard.

Pic. 5 Cardboard box containing OCT-box

Pic. 6 Cardboard box containing slit lamp

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5 Installation

The installation of the SL-OCT unit is started with the build up of the lift table. The next part is the
assembly of the OCT-box onto the lift table. Afterwards, the slit lamp including the permanently mounted
scanner-box is installed onto the lift table. At the end of the installation procedure, test measurements
are carried out to ensure correct operation of the device.

5.1 Lift table

The first step is the assembly of foot and column. Take
the column out of its package and place it on top onto
e.g. a cellular plastic backing (see Pic. 7).

cellular plastic backing

Pic. 7 Column prepared for assembly of foot

Remove the four Allen screws (M6 x 40) and spring washers needed for
the assembly of the foot.

All screws and washers necessary for assembly are provided,
slightly screwed into their respective screw holes!

Control the cable laying. The mains cable of the column must lay in
the slit (see Pic. 9).

Pic. 8 Premounted screws for

assembly of the foot

Pic. 9 Cable laying of mains cable

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Mount the foot onto the column (see Pic. 10). The
longer part of the foot must be oriented towards the the
cable outlet of the column. The computer screen will
later be mounted onto this side of the table. Therefore,
the correct orientation of the foot is essential for the
stability of the table.

Pic. 10 Foot onto column mounted

Now clip in the four wheels onto the foot.

Pic. 11a Wheels

Pic. 11 Clip in the wheel

Turn around column and mounted foot (see Pic. 12a). Then, connect mains and lift the column until the
stop at end (see Pic. 12).

Attention: Be very careful not to touch the cables in the open
control console as they are alive! As soon as the column is
lifted, disconnect the mains!

Pic. 12a Column not lifted

Pic. 12 Column lifted till stop at end

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After disconnecting mains, the tabletop is prepared. Remove the screws and washers from the screw
holes for the column (M6 x 25 and spring washers) and control console (M6 x 16 and spring washers)
(see Pic. 13 red and green).

Multible power
socket

Assembly of
head rest

Assembly of
control console

Assembly of
column

Pic. 13 Table top (bottom) with premounted screws and washers

Mount the tabletop onto the column. Use the short
Allen screws for the console and the long ones for
the column.

Assembly of
monitor fixation

Pic. 14 Mounting of table top onto the column

If there is an optional printer arm delivered with the SL-OCT, it can be assembled at this state of the
installation or at the end of the assembly procedure. Please refer to section 5.2.

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Pic. 15a rear side of mounted monitor unit

Pic. 15 Mounted monitor including keyboard

fixation arm

The computer screen is mounted together with the keyboard fixa tion arm on its fixation arm. The other
end of the monitor fixation arm is mounted beneath the tabletop (see Pic. 15a and Pic. 15).

There are two possible ways for mounting the monitor unit onto the table:

1. Premounting of monitor arm, keyboard arm, and monitor before assembly of the whole unit onto
the lift table.
This is recommended if several persons are installing the device together.

2. Premounting of monitor arm and lift table before assembly of keyboard arm and monitor.
This might be more comfortable if there is a single person installing the device. It is easy to
adjust the monitor fixation arm with one hand while looking beneath the tabletop and mounting
the screws. Handling the whole premounted unit with one hand while adjusting the screws
beneath the table needs more strength.

Avoid touching the surface of the screen.

Pic. 16a Monitor arm and keyboard arm

Pic. 16 Rear side computer screen with its screws

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1. Premounting of monitor unit

Put the computer screen with the screen facing downwards
onto a table parallel to the table’s edge (see Pic. 16).
Remove the screws (Allen screws M4 x 20). Place the
keyboard arm onto the monitor with the angled part
hanging down. Now place the monitor arm on top and
screw all parts together (see Pic. 17).

Pic. 17 Mounted monitor unit

Remove the screws from the tabletop (see magenta arrow in Pic. 13 and
Pic. 18).

Pic. 18 rear side of tabletop in detail

Place the monitor unit so that the keyboard arm is on top of the lift table and
the angled part of the monitor arm is beneath the table (see Pic. 15a).
Assembly the 4 Allen screws (M6 x 20). Adjust the computer screen into the
right position by turning it slightly around the middle screw before fastening
the screws.

2. Premounting of the monitor arm

Remove the screws from the tabletop (see Pic. 13 magenta
and Pic. 18). Assemble the monitor arm (see Pic. 16a) at the
lift table (see Pic. 20).
Do not fully fasten the screws (M6 x 20) until the computer
screen is mounted and adjusted.
Plug in mains and lower the lift table to a convenient height.

Pic. 19 Mounted monitor arm

Pic. 20 Mounted monitor arm