OCULUS ImageCam 3 User manual

OCULUS ImageCam®3
INSTRUCTION MANUAL
Slit Lamp Documentation System

Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) i / v
Notes on this
Instruction Manual
The ImageCam® 3 software was manufactured and tested under strict
quality criteria. You have selected a modern and well-engineered product.
To ensure safe operation, it is essential that you use the ImageCam® 3
software correctly. For this reason, you should thoroughly familiarize
yourself with the contents of this instruction manual before operating the
device. In particular, pay attention to the safety instructions!
This operating manual describes the management of the patient
data, how to perform an examination, and the presentation options
for the captured, single images.
The operating manual for the beam splitter can be found in the
Appendix (sect. 19.1, page 65).
Due to ongoing development, the diagrams shown here may vary slightly
from the actual software delivered.
If you have any questions or would like additional information about your
device, please do not hesitate to contact us by mail or fax. Our team will
be happy to assist you.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 13485, setting high stan-
dards of quality for the development, manufacture, quality assurance and
service of the entire range of products.

Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) ii / v
Table of Contents
1 Scope of Delivery.........................................................................................................................1
2 Structure of the Documentation ............................................................................................1
3 Symbols..........................................................................................................................................2
4 Safety Instructions......................................................................................................................3
4.1 About this Manual .........................................................................................................3
4.1.1 Pictograms Used in this Manual ..............................................................3
4.2 Safety Instructions for Use..........................................................................................4
5 Intended Use.................................................................................................................................8
6 Device Description ......................................................................................................................8
6.1 How the ImageCam® 3 Works....................................................................................9
7 First-time Operation...................................................................................................................9
8 Putting Back Into Operation................................................................................................. 10
8.1 Install Software............................................................................................................ 10
8.2 Connect Foot Switch .................................................................................................. 10
9 Preparing for Capturing Images........................................................................................... 11
9.1 Starting Patient Data Management....................................................................... 11
9.1.1 Entering a New Patient............................................................................ 12
9.1.2 Selecting an Existing Patient ................................................................. 12
9.2 Starting the ImageCam® 3 Programme ................................................................ 13
9.3 Preparing the Camera ................................................................................................ 14
9.3.1 Select Slit Lamp Magnification ............................................................. 15
9.3.2 Select Exposure Programme ................................................................... 16
9.3.3 Adjust the White Balance ....................................................................... 17
9.3.4 Editing Pre-Set Exposure Programmes, If Necessary....................... 19
9.3.5 Saving User-Defined Exposure Programmes...................................... 21
9.3.6 Shortcut Assignment to Exposure Programmes C1 through C4 .. 22
10 Capturing an Image or Recording a Video........................................................................ 23
10.1 Capture (Grab) Image................................................................................................. 24
10.2 Capture 5 Images in a Row ...................................................................................... 24
10.3 Capture 5 Images in a Row with Incremented Brightness.............................. 24
10.4 Record Video................................................................................................................. 24
10.4.1 Recording a Video Using the Foot Switch .......................................... 25
10.5 Saving Images and Videos ........................................................................................ 25
10.6 Optimisation of the Image Quality......................................................................... 26
11 Viewing the Images ................................................................................................................. 27
11.1 Overview of the ImageCam® 3 Programme......................................................... 27
11.2 Select Image/Video ..................................................................................................... 27
11.3 Display Image ...............................................................................................................28
11.4 Zooming an Image and Panning an Image Section........................................... 28
11.5 Identify lengths and angles ...................................................................................... 29

iii / v Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
11.5.1 Determine distances..................................................................................29
11.5.2 Identify Angles for Toric Contact Lenses.............................................34
11.6 Copy and Insert Image ...............................................................................................34
11.7 Edit Image......................................................................................................................35
11.8 Print Image ....................................................................................................................36
11.9 Import Image.................................................................................................................37
11.10 Export Image.................................................................................................................37
11.11 Delete Image .................................................................................................................38
11.12 Capture an Image from a Video...............................................................................39
11.13 Change Settings ...........................................................................................................40
11.13.1 Buttons and Displays.................................................................................41
11.13.2 Change Date Format .................................................................................41
11.13.3 Select Language .........................................................................................41
11.13.4 Set Video Format........................................................................................41
11.13.5 Compress Images........................................................................................42
11.13.6 Display System Settings Information ...................................................42
12 Patient Data Management ....................................................................................................43
12.1 Rename Patient Data..................................................................................................43
12.2 Exporting Patient Data...............................................................................................43
12.3 Import Patient Data ....................................................................................................44
12.4 Data Backup ..................................................................................................................46
12.4.1 Backup Data.................................................................................................46
12.4.2 Restoring Data ............................................................................................47
12.4.3 Automatic Backup......................................................................................47
12.5 Change Settings ...........................................................................................................48
12.5.1 “Main” Tab....................................................................................................49
12.5.2 “Devices” Tab...............................................................................................51
12.5.3 “Import/Export” Tab...................................................................................53
12.5.4 “Email” Tab...................................................................................................55
12.5.5 “Interface” Tab ............................................................................................56
12.5.6 “Smartcardreader” Tab..............................................................................57
12.5.7 “Misc”6 Tab..................................................................................................58
12.5.8 Tab Panels “Hecht” and “DICOM”..........................................................58
13 Cleaning and Maintenance....................................................................................................59
14 Troubleshooting ........................................................................................................................59
15 Transport and Storage.............................................................................................................61
15.1 Transport and Storage Information ........................................................................61
15.2 Dismantling and Packing...........................................................................................61
16 Disposal .......................................................................................................................................62
17 Terms of Guarantee and Servicing ......................................................................................62
17.1 Terms of Guarantee.....................................................................................................62
17.2 Assumption of Liability for Functions and Damage...........................................63
18 Technical Data...........................................................................................................................64

Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) iv / v
19 Appendices................................................................................................................................. 65
19.1 Operating Instructions for the Beam Splitter...................................................... 65
19.1.1 Technical Data Beam Splitter................................................................. 66

v / v Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)

1 Scope of Delivery
Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) 1 / 68
1 Scope of Delivery
We reserve the right to change the scope of delivery in line with ongoing
technical development.
If you find transport damage upon delivery, immediately file a claim
with the transport company.
Have the damages noted on the bill of lading, so that your claim for
damages can be handled properly.
Keep the packaging in a safe place. You can then ship or transport
the unit in the proper manner for any servicing or repairs that may
arise. You can thus avoid unnecessary damage and costs.
Note
We reserve the right to change the scope of delivery in line with ongoing
technical development.
2 Structure of the Documentation
A folder containing documentation is supplied with your ImageCam® 3:
Instruction Manual: The design of the unit is described in detail in
this document. The instruction manual also gives you general
information about working with the Patient Data Management
system and all safety-related instructions for use of the
ImageCam® 3.
Components Order Number
ImageCam® 3, consisting of
Camera modul ImageCam® 3
Beam splitter
69200, 69210, 69220,
69230, 69240, 69250,
69260, 69270, 69280,
69290, 69300, 69310,
69320, 69330
Data medium with ImageCam® 3 software 70989
USB foot switch 77006
USB 3.0 Cabel, 5 m 05200701
USB 3.0 Extension cable, 5m 05460332
USB 3.0 Extension cable, 1,5m 05200706
Instruction Manual ImageCam® 3
Software Installation
G/69200/XXXX/EN 0120 Rev01
SI/50000/.../en

3 Symbols
2 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
Software Installation: The introduction to the Software Installation
describes how to install the ImageCam® 3 software and the
associated drivers.
3Symbols
Symbols on device Symbols packaging
Manufacturer Date of
manufacture
Keep dry
Conformité
européenne
Article number This way up
Follow instruction
for use
Serial number Fragile
Disposal in
household trash is
prohibited
Caution Limit of temperature for
transport
Limit of temperature for
storage
Limit of humidity
Example: UDI number, consisting UDI-
DI (Device-Identification)
UDI-PI (Product Identifier)
machine-readable matrix code
Limit of air pressure
Transport
Storage
Fig. 3-1: Name plate (example)

4 Safety Instructions
Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) 3 / 68
4SafetyInstructions
4.1 About this Manual
Carefully read through the Instruction Manual.
Keep the Instruction Manual in good condition near the device.
Observe the legal regulations with regard to accident prevention.
4.1.1 Pictograms Used in this Manual
Attention
Identifies a potentially dangerous situation which may cause minor injury
or damage to property.
Note
Denotes situations which could result in incorrect findings, denotes user
instructions and useful or other important information.
☞
Identifies important information about the product and its use, which
require special attention.
>This symbol denotes menu paths and screen shots. Example for
starting a new examination:
ImageCam® 3 > Examination > New
which means:
Select the “Examination” menu from the menu bar.
Select the menu item “New Examination”.

4 Safety Instructions
4 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
4.2 Safety Instructions for Use
Attention
Personal injury or property damage due to improper operation
Observe the following safety instructions.
Personal injury or property damage due to equipment modifications that
could jeopardize safety
No modifications may be made to this device without the permission
of the manufacturer.
Instructions for Operating Personnel
Make certain that the ImageCam® 3 is used exclusively by personnel
that have the training and practical experience to safely and
properly operate the equipment.
Instructions for Setup and Connection
Do not operate or store the ImageCam® 3 in damp rooms.
Keep the ImageCam® 3 away from water that may drip, surge or
splash and make sure that no liquids can enter the ImageCam® 3. Do
not place any containers holding liquids in the vicinity of the
ImageCam® 3.
Germany: Only operate the ImageCam® 3 in rooms used for medical
purposes if VDE 0100 installation procedures have been observed.
Do not operate the devices included in the delivery in areas where
explosions may occur, or in proximity to flammable anaesthetics or
volatile substances such as alcohol, benzine or similar products.
Do not use excessive force when connecting the electrical plug.
If a connection is not possible, check whether the plug fits the
socket.
If you find damage to the plug connector, have the damage
corrected by our service department.
Instructions for Operation
Never operate an ImageCam® 3 that is damaged.
Only operate the ImageCam® 3 with the original accessories
supplied by us and only when the unit is in a technically perfect
condition.
Before first use: Let OCULUS or an authorized dealer train you in the
operation of the ImageCam® 3.
Only operate the device if you have understood the operating
instructions.

4 Safety Instructions
Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) 5 / 68
Instructions for Maintenance
To ensure satisfactory and reliable operation, we recommend: Have the
ImageCam® 3 checked every two years by our service department or an
authorized dealer. If an error occurs which you cannot correct, label the
ImageCam® 3 as being “out-of-order” and contact our Service
Department.
Instructions for Disassembly and Disposal
When disconnecting electrical connections, pull on the respective
plug instead of the cable itself.
Dispose of the device according to legal regulations.
Patient environment information
Patient environment is the area where patients can come into contact
with any part of a medical electrical equipment (ME equipment) or with
another person being in contact with the ME equipment.
In the patient environment, use devices that conform to IEC 60601-
1. If a multiple power socket is to be used, or if a device is to be used
that
does not meet the IEC 60601-1 standard, use an isolating
transformer.
EMC and Electrical Safety Information
The ImageCam® 3 and a slit lamp constitute a Medical Electrical System
(ME System) in accordance with DIN EN 60601-1. If you connect any
more devices, they too become part of the ME System.
? Make sure that all devices of the ME System meet the provisions of
IEC 60601-1 or of IEC 60950-1

4 Safety Instructions
6 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
Instructions on Electrical Safety
Attention
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the ImageCam® 3 with its non-medical electrical equipment
(e.g. data processing equipment) to a medical electrical system must not
result in a patient safety level below that prescribed by DIN EN ISO
60601-1. If making this connection leads to the leakage current threshold
being exceeded, protective measures including a circuit breaker must be
in place.
Ensure that connections with non-medical devices are made
correctly.
Use only a computer that meets the specifications given in this
instruction manual, sect. 18, page 64.
Attention
Electromagnetic Compatibility (EMC / Cables)
Risk of personal injury or damage to property due to electromagnetic
interference
Portable and mobile HF communications appliances (high frequency) can
affect medical, electric equipment.
Make sure that portable and mobile RF communications equipment
do not cause interference.
Recommendation: Maintain a minimum distance of 4 m. If the
distance is shorter, you must ensure that the ImageCam® 3
functions correctly.
Cybersecurity
☞
Do not use the ImageCam® 3 with wireless technology, for example with
wireless USB.
To ensure cyber security in order to the usage of the device, the following
security measures should be considered. Contact your computer
administrator:

4 Safety Instructions
Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) 7 / 68
Precautions for access control of the computer
 Secure the computer with a password (for example at Windows start up).
Choose a complex password: A good password should be at least
eight characters long and are not in the dictionary. In addition to
letters, it should also include numbers and special characters.
Do not choose a name or device name for a password (for example
“ImageCam”).
Change the password regularly.
Do not note the password in an accessible location.
Use different passwords for different users.
Enable the screen saver and use the option for the necessity of re-
entering the password when exit the screen saver.
Choose an adequate time setting for starting the screen saver if
software session is inactive (e.g. 10 minutes). Adequate time setting
should consider duration of examination, number of patients, time
between examinations, use of other devices in the examination
room, several user, etc.
Lock the computer if you are leaving the workstation (shortcut:
‘windows logo key’ + ‘L’).
Precautions if the computer is connected to a LAN or internet network
Prefer wired connections of the computer to the network.
If you are using Wi-Fi connections nevertheless, please ensure the
usage of adequate security methods (for example WPA2/AES – Wi-
Fi Protected Access / Advanced Encryption Standard – with a strong
network key).
The usage of a firewall (software or hardware) is recommended.
Recommendation: Use anti-malware tools with up to date malware
definitions.
Note
Also observe the regulations, notes and recommendations of the
Bundesamt für Sicherheit in der Informationstechnik for the protection of
critical infrastructures.

5 Intended Use
8 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
5 Intended Use
The ImageCam® 3 system is intended for the use described in this
operating manual.
It is used to capture, process and archive images and video sequences of
the slit lamp examination.
Make sure that the device is only be used by personnel, who, due to their
training or their knowledge and practical experience, can guarantee
proper handling of the device.
Heed the safety instructions listed above.
Contraindications
not known
6 Device Description
1 Lever for swivelling in and out beam splitter prism 4 Aperture
2 Beam splitter 5 PC cable connection (with safety elements)
3 Adapter plate 6 PC cable connection (without safety elements)
Fig. 6-1: Equipment overview of the ImageCam® 3
1
5
2
3
4
6

7 First-time Operation
Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) 9 / 68
6.1 How the ImageCam® 3 Works
The ImageCam® 3 is used to capture, process and archive images and
video sequences
Technical Principle:
The ImageCam® 3 can be mounted to any slit lamps of a suitable design,
sect. 19.1.1, page 66.
The beam splitter splits the light of one of the two beam paths of the slit
lamp: One part is directed through the binocular viewer to the examiner’s
eyes, so that he sees a stereoscopic image, as usual. The other part is
directed into the camera of the ImageCam® 3 so that the images and
video sequences can be recorded.
The image brightness and the depth of field of the image can be selected
with the aperture control knob (4).
If no images need to be captured, you can swivel the beam splitter out of
the way with a lever (1). You then have an optically fully unmodified slit
lamp.
7 First-time Operation
Before you put the ImageCam® 3 into operation for the first time, you
must first
have it installed and set up
have the beam splitter and camera hardware mounted
connect the foot switch, if necessary sect. 8.2, page 10
Attention
Risk of incorrect values/equipment damage due to improper setup
Please note that the ImageCam® 3 must be set up, connected and
instructed by our Service Department or by an authorized OCULUS
technician prior to initial use.
Then proceed as described in sect. 9, page 11.

8 Putting Back Into Operation
10 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
8 Putting Back Into Operation
If you want to put the ImageCam® 3 back into operation, e.g. due to a
software update, the following setup jobs may need to be done.
Install the software, sect. 8.1, page 10
Connect the foot switch, sect. 8.2, page 10
Note
Risk of damage to the devices if not handled properly
Do not expose the ImageCam® 3 to any vibrations, shocks,
contaminants, moisture, or high temperatures.
Handle the optical device with care.
8.1 Install Software
The ImageCam® 3 software consists of two programmes that are installed
together. You will find the details of the installation in the Software
Installation Manual.
Installation requirements:
Administrator rights
Laptop/PC as specified in the Technical Data, “Recommended
Computer Requirements” on page 64,
8.2 Connect Foot Switch
If needed, you can connect a foot switch. You can use this foot switch to
capture an image, or to start and stop recording a video sequence,
sect. 11.13.6, page 42
Prerequisite: USB port
Plug the USB connector of the foot switch into a USB port at your
computer.
The foot switch is active.

9 Preparing for Capturing Images
Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01) 11 / 68
9 Preparing for Capturing Images
Before you can capture images or record video sequences with the
camera, you must first make some preparations: These include:
Start the Patient Data Management, sect. 9.1, page 11
Start the ImageCam® 3 programme, sect. 9.2, page 13
Prepare the camera, sect. 9.3, page 14
9.1 Starting Patient Data Management
You must enter patient data in the Patient Data Management and then
use it. After you have switched on the PC, it first loads the operating
system. If the Windows desktop is displayed, you have to start the Patient
Data Management programme from there.
If necessary, click on the ImageCam® 3 icon: .
The user interface for the Patient Data Management is displayed
1 “Functions” group box 5 [Export] button
2 Previous examinations 6 [Import] button
3 [Delete exam.] button 7 Patient list
4 [Delete Patient] button 8 “Patient” group box
Fig. 9-1: Patient Data Management user interface
1
2
3
6
7
8
5
4

9 Preparing for Capturing Images
12 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
☞
To start the ImageCam® 3 programme, first enter a new patient (8) or
select an existing patient from the list of patients (7).
For more information on Patient Data Management, refer to the sect. 12,
page 43.
9.1.1 Entering a New Patient
Press the [New] button to enter a new patient in the Patient Data
Management system.
Enter the patient’s last name, first name and date of birth in the
patient window.
Optionally you can enter an ID number for the patient.
To save the data you entered, click [Save].
The patient you have just entered now appears in the patient list.
9.1.2 Selecting an Existing Patient
The patient data list on the left-hand side of the screen displays all
previously examined patients in alphabetical order.
Choose [Search] to quickly find the patient you are looking for in the
list.
Enter the patient’s name or the first letter of the name in the “Last
name” field.
Alternatively, you can search for the patient using an ID number,
first name or date of birth, assuming that one was assigned when the
patient was first recorded.
Fig. 9-2: Entering patients
Fig. 9-3: Patient list

9 Preparing for Capturing Images
Instruction Manual ImageCam® 3 (G/70750/1111/de) 13 / 68
In the list that appears, click the entry you were searching for to transfer the
patient’s name to the patient window. This also brings up a list of any previous
examinations for that patient in the examination window (bottom right side).
Extended Patient Search: [Extended] check box
Click on the [Extended] check box.
The screen displays additional search parameters which reference previous
examinations, for example.
Enter a search parameter.
The patient in question is highlighted in the list.
Press the [Quit search] button.
Proceed in the same way as you would when inputting a patient name.
9.2 Starting the ImageCam® 3 Programme
Transition Patient Data Management => ImageCam® 3 Programme
After selecting a patient: Press the [Imagecam] button to start the ImageCam® 3
programme.
or
Double-click the selected patient name to start the ImageCam® 3 programme.
Fig. 9-4: Extended search

9 Preparing for Capturing Images
14 / 68 Instruction Manual ImageCam® 3 (G/69200/XXXX/EN 0120 Rev01)
The following overview is displayed:
9.3 Preparing the Camera
Before capturing an image or recording a video sequence, you must
prepare the camera. This includes:
Select a zoom factor, sect. 9.3.1, page 15
Select an exposure programme, sect. 9.3.2, page 16
Adjust the white balance, if necessary, sect. 9.3.3, page 17
Edit a pre-set exposure programme, if necessary, sect. 9.3.4, page 19
Save the edited exposure programme, if applicable, sect. 9.3.5,
page 21 and sect. 9.3.6, page 22
To prepare for the image capture, switch over to the Image screen:
1 Patient and examination data 5 Image: Large view
2 Toolbar 6 Image: Date and Time
3 Menu bar 7 Info text field
4 Image bar with thumbnails of the images 8 Zoom factor
Fig. 9-5: ImageCam® 3 programme operation
4
5
3
6
8
2
1
7