Heidelberg SL-OCT Operating Instructions

SL-OCT™
Slit Lamp-OCT™
Anterior Segment Imaging

Operating Instructions

Software Version 1.0.2.0

© Heidelberg Engineering GmbH
July 2007
Part No.

97079-006 A4 Rev. 006

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 (MD 93/42/EEC).

Caution! Do not use the SL-OCT™ without reading this manual. Failure to
adhere the instructions of this manual may compromise data and results.

This product is manufactured under one or more of the following patents:

DE 100 35 835, DE 198 12 297, EP 0 941 692, US 6,095,648

Corporate Headquarters

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

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

U.S.A.

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

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

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

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

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

TABLE OF CONTENTS

1 GENERAL INFORMATION 5

1.1 INTENDED USE 5

1.2 OPERATIONAL ENVIRONMENT 5

1.3 PRINCIPLES OF THE TECHNOLOGY 5

1.4 CAUTIONS, WARNINGS, AND CONTRAINDICATIONS 5

1.5 SYSTEM INSTALLATION 7

1.6 SYSTEM COMPONENTS 9

1.7 MAINTENANCE 9

2 SOFTWARE CONFIGURATION 10

2.1 HEIDELBERG EYE EXPLORER 10

2.2 VIEWING SOFTWARE 10

2.3 NETWORK ENVIRONMENTS 10

2.4 INTEGRA TION WITH EMR OR PRACTICE-MANAGEMENT SOFTWARE 10

3 STARTING AND POWERING DOWN THE SYSTEM 11

3.1 HARDWARE POWER ON 11

3.2 VERIFY SOFTWARE INSTALLATION 12

3.3 STARTING HEYEX 12

3.4 EXITING HEYEX 12

3.5 HARDWARE POWER OFF 13

4 DATABASE VIEWING WINDOW 14

4.1 OVERVIEW 14

4.2 DATABASE VIEWING WINDOW TOOLBAR 14

4.3 SEARCH FILTERS 15

5

PATIENT RECORDS 17

5.1 CREATING A NEW PATIENT RECORD 17

5.2 OPENING AN EXISTING PATIENT RECORD 21

5.3 EXAMINA TION TABS 21

5.4 LOADING MULTIPLE RECORDS FOR BATCH FUNCTIONS 23

6 IMAGE VIEWING WINDOW 24

6.1 OVERVIEW 24

6.2 IMAGE VIEWING WINDOW T OOL BAR 24

6.3 EDITING AND VIEWING FUNCTIONS 25

6.4 EXAMINATION TABS 26

6.5 LIGHTBOX 26

6.6 PREVIEW PANE 28

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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7 IMAGE ACQUISITION WINDOW 29

7.1 OVERVIEW 29

7.2 IMAGE ACQUISITION WINDOW T OOLBAR AND CONTROLS 30

7.3 ON-LINE QUALITY SCREENING 31

7.4 SAVING IMAGES 31

8 IMAGE ANALYSIS WINDOW 32

8.1 OVERVIEW 32

8.2 IMAGE ANALYSIS WINDOW TOOLBAR 33

8.3 SEGMENT ATION TAB 34

8.4 AUTO-BIOMETRY™ TAB 36

8.5 INTERACTIVE DISTANCE TAB 38

8.6 INTERACTIVE PACHYMETRY T AB 40

8.7 DIGITAL GONIOSCOPY™ TAB 43

8.8 PRINTING REPORTS 45

9 IMAGING PROCESS 46

9.1 PREPARING THE DEVICE 47

9.2 PREPARING THE PA TIENT 47

9.3 FIXATION TARGETS 47

9.4 ALIGN THE IMAGE 48

9.5 STOP/AUTO-STOP 48

9.6 VERTICAL IMAGING 49

10 EXPORT AND IMPORT OF IMAGES AND DATA 50

10.1 EXPORT 50

10.2 IMPORTING 51

SETUP /CONFIGURABLE OPTIONS 52

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11.1 GENERAL 52

11.2 DISK SPACE 52

11.3 PLUG INS 53

12 TECHNICAL SPECIFICATIONS 54

APPENDIX A: TECHNICAL NOTES 57

APPENDIX B: DISPOSAL 58

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

Section 1- General Information

1 GENERAL INFORMATION

This is an introduction to the Heidelberg Slit Lamp-OCT™ (SL-OCT™) with operating software
version 1.0.2.0. These operation instructions also contain important safety information.

1.1 Intended use

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.

The SL-OCT is intended for use as a diagnostic device to assist in the diagnosis of the anterior seg­ment of the eye.

1.2 Operational Environment

The intended operational environment of the device is a clinical setting, medical prac­tise or similar location under the direction of a trained ophthalmologist or optometrist.

1.3 Principles of the technology

The SL-OCT combines slit lamp technology with optical coherence tomography (OCT). The OCT
imaging component of the SL-OCT is of a time domain OCT interferometer. The principle of time
domain OCT is well known from the literature and is described elsewhere. The SL-OCT device
uses a short coherent infrared light source. The light source is a super-luminescent light emitting
diode with a central wavelength around 1310 nm. The source beam is divided into two compo­nents, the sample beam which enters and is reflected back from the eye and the reference beam
which passes a delay line. The length of the delay line is modulated over the measurement depth
within one A-scan. The beams are recombined, and the OCT signal is calculated from the resulting
interference patterns. This OCT signal is used to produce an A-scan with precise depth informa­tion. The SL-OCT scanning beam moves across the eye providing multiple A-scans which are
combined to form a two-dimensional, cross-section scan, like an ultrasound B-scan.

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 Hei-

delberg 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.

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 1- General Information

WARNING Make sure that the environmental requirements are met when the system is oper-

ated. 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 meas-

ured 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 analyse 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 analyse 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

acclimate 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.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

Section 1- General Information

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.

CAUTION Read subsection “Imaging Process” 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” 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 Practi-

tioner

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”.

1.5 System installation

Accompanying these operating instructions you will find detailed installation instructions in the
document “Installation Instructions for SL-OCT™”.

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 1- General 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.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

1.6 System components

Section 1- General Information

Mounted scanner unit

Slit lamp

(HAAG-STREIT BD 900)

Motorized lift table

SL-OCT H

ARDWARE COMPONENTS

Monitor

Keyboard / mouse

OCT unit (embedded PC)

Printer (not pictured)

The SL- OCT examination system is based on a slit lamp modified for use with an OCT device.
The slit lamp's functionality is in no way impaired by this modification. The scanner unit is
permanently attached to the slit lamp illumination and projects the OCT measurement beam over
the same path as the visible slit lamp beam.

1.7 Maintenance

The Heidelberg SL-OCT is a precision optical measuring instrument. Protect the instrument
against dust and moisture, and avoid shocks and the action of strong forces.

Please maintain the slit lamp according to the instructions in the slit lamp operations manual
(provides with this document). When necessary, the inclined mirror on the front of the slit lamp

can be carefully cleaned using a lens cloth and a small amount of isopropyl alcohol or distilled
water.

The non-optical surfaces of the instrument can be cleaned and/or disinfected with traditional

products as necessary. Any standard cleaning product appropriate for plastic surfaces which do not
contain acetone or hydrogen peroxide (e.g. ethanol and isopropyl alcohol disinfectants) may be

used for this purpose. Before doing this, please turn off the system power at the main switch.

A yearly inspection of the device by a Heidelberg Engineering Service unit is highly recommended
to ensure proper and exact operation.

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 2- Software Configuration

2 SOFTWARE CONFIGURATION

2.1 Heidelberg Eye Explorer

The software of instruments from Heidelberg Engineering runs on the Heidelberg Eye Explorer

(HEYEX), a platform operating within the Microsoft Windows Operating System™. The HEYEX

platform provides all basic functions of the patient database and patient records.

2.2 Viewing software

In addition to the complete operating software (image acquisition and viewing) installed on the
instrument, optional HEYEX SL-OCT Viewing Software is available. This allows for analysis and
review of images on PC’s separate from the SL-OCT system. Please contact Heidelberg
Engineering or your local distributor for further information.

2.3 Network environments

For simultaneous use of the software on several computers within a network, additional
networking licenses can be purchased. For more information, please contact Heidelberg
Engineering or your local distributor.

2.4 Integration with EMR or practice-management software

The HEYEX operation system can be connected to patient data management software systems
(e.g. ICSP med, Fidus, IFA, Medistar, Duria, SEDOC, VIP Vision, WinPro, NextGen, IPRO,
Turbomed, Dr. Notes, and Medisoft). This enables quick and convenient import of patient data into
the digital patient record. Should your patient data management system currently not offer
connection to the HEYEX, Heidelberg Engineering can supply the data exchange program to your
provider for implementation. Please contact Heidelberg Engineering or your local distributor for
further information.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

Section 3- Starting and Powering Down the System

3 STARTING AND POWERING DOWN THE SYSTEM

3.1 Hardware power on

To facilitate daily operation, power supplies for all SL-OCT hardware components are connected

to a single, main power switch.
The main power switch is on the control box of the motorized lift table (table) (see illustration).

OR

Original Configuration

The daily power on process is simply:

• Confirm power cables are properly connected

• Confirm Slit lamp and OCT unit are switched on

• Power on system using the main power switch

>> Green lights on the three switches will light up

>> System will power up to password protected login screen.

>> User name: SL-OCT is automatically supplied

• Enter password: “sloct” (Note: password is case sensitive and has no spaces)

>> System opens to windows desktop

• Start HEYEX operating software with the HEYEX desktop icon

Note: The main power switch located close to the lift table raise/lower control switch. When

adjusting table height, be careful not to inadvertently power off the device; if you do, unsaved
images or data entries will be lost.

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 3- Starting and Powering Down the System

3.2 Verify software installation

In order to use the Heidelberg SL-OCT, the hardware and software must first be correctly installed.
To confirm the software is present:

• Go to the Windows desktop.

• Click on Start –– Settings – Control Panel – Add/Remove Programs.

The following items must be listed:

• Heidelberg Eye Explorer

• Heidelberg Eye Explorer License Manager

• SL-OCT

If these programs are not listed, please contact technical support.

3.3 Starting HEYEX

Start HEYEX by double-clicking the Eye Explorer desktop icon:

OR

By using the windows Start Menu:

Start → Programs → Heidelberg Eye Explorer →

Heidelberg Eye Explorer

The software opens to the Database V iewing Window. (See section 4 for details.)

3.4 Exiting HEYEX

To close the program, click the

button at the upper-right corner of the screen.

OR

With the File menu: File → Exit.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

Section 3- Starting and Powering Down the System

Select Yes when prompted with “Do you want to exit the program?”

HEYEX is programmed to pop-up a confirmation window before closing the program. This is a

configurable option which can be switched off. (See chapter 11, Setup / Configurable Options).

3.5 Hardware power off

Power down is a typical Windows process.

• Exit HEYEX and all open applications

• Click: Start → Shut down→ Shut down

>> Computer will power down and give a “Safe to Turn Off” message.

• Use the main power switch (section 3.1) to turn off system power

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 4 – Database Viewing Window

-

R

e

s

Q

r

r

4 DATABASE VIEWING WINDOW

4.1 Overview

The left side of the Database V iewing window shows all patient records in the database. The right

side of the window lists “active” patient records available for new examinations, review or batch
processing.

uick

Menu ba

Icon ba

Database Viewing Win

Patient
database

/ Active Selected Patients

cord

Closing the Database Viewing window will shut down the HEYEX program. HEYEX is
programmed to pop-up a confirmation window before closing the program. This is a configurable

option which can be switched off (See chapter 11, Setup / Configurable Options).

4.2 Database Viewing Window toolbar

The Database Window icon brings you to the database viewing window.

The Image Window icon brings you to the image viewing window (section 6).

The Filter, Load Filter, and No Filter icon functions are described in section

4.3.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

Section 4 – Database Viewing Window

The Properties icon opens the Patient Data window (section 5.1) for the selected patient. If

no patient record is selected, it is inactive.

The New Patient icon opens a new Patient Data window for creating a new patient record.
(See chapter 5, Patient Records for details)

The New Examination icon opens a new Examination Data window to begin a new
examination for the selected patient. (See chapter 5, Patient Records for details.)

The Load icon “loads” the selected patient or exam record(s) into the active, right-hand

side of the database window.

The Unload icon moves the selected record(s) out of the active side of the database

window.

The Load All icon moves ALL records into the active window. This is generally used only

for database export functions.

The Unload All icon removes all records from the active side of the database window

4.3 Search filters

4.3.1 Quick Search

This feature allows users to quickly filter the database by patient name. For example, entering the

letters “Mu” and then pressing Enter (or clicking Update Display) will update the database

window with only those patients whose last names begin with “Mu”.

It is also possible to search by both last and first names. For example, if the entry “Mu,n” is
entered, only patients with a last name starting with “Mu” and first name starting with “N” will be
displayed.

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 4 – Database Viewing Window

The quick search by name works only on the left side (patient database) window. It will not affect
the right side (selected patient) window.

4.3.2 Filtering

More complex filter operations are available using the Filter icons. With these tools the database
can quickly be filtered by: patient name, referring physician or clinic, time (date range), diagnosis,
participation in a study or the acquisition device. Multiple filter criteria can be used on a single
sort.

The Filter icon (section 4.2) opens the Database filter window with several filtering options. In

the example shown below, all patients that have been examined within the last 10 days, AND that
have an exam marked as part of the “Angles in darkness” study, will be displayed.

A set filter parameters (like those in the example above) can be named and saved for future use

with the [Save as] button. A list of previously saved searches can be viewed via the Load Filter

icon (section 4.2).

The No Filter icon removes all filter criteria, returning the database display to the full list.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079

Section 5- Patient Records

5 PATIENT RECORDS

5.1 Creating a new patient record

When examining a patient for the first time, a patient record must be created. As with many other
program functions, there are several ways to open the Patient Data window.

Click the New Patient icon.

OR

Use the Record menu: Record > New Patient.

5.1.1 Patient Data Tab

Enter last name, first name, date of birth and gender (sex). All other data are optional.

Use the tab key to move to the next data entry field.

SL-OCT Operating Instructions 1.0.2 - Part No. 97079

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Section 5- Patient Records

Once all entries have been made, click OK to save the new patient record and begin the

examination. (See sections 7 and 9, Image Acquisition Window and Imaging Process).

The Cancel button ends the procedure and the patient record will not

Clicking the Close Window button (

) in the top right corner of the window will also cancel the

be created or saved.

procedure and no patient record will be created.

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SL-OCT Operating Instructions 1.0.2 - Part No. 97079