Optomed Aurora User manual

USER MANUAL

User manual for Optomed Aurora ophthalmic camera
Optomed Aurora
Manufacturer:
Optomed Oy (Ltd)
Yrttipellontie 1,
FI-90230 Oulu
Finland
Tel: [phone]
[e-mail]
www.optomed.com
English 60000888
R 6.0
2019 07 01

1 Safety 6
1.1 Symbols 6
1.2 Intended use 10
1.3 Contraindication 10
1.4 Precautions 11
2 Device overview 13
2.1 Controls and display icons 14
3 Getting started 16
3.1 Part list and unpacking 16
3.2 Preparations 16
4 Features 19
4.1 Quick menu 19
4.2 Camera settings 21
4.3 Optics settings for Aurora Retinal Module 23
4.4 Optics settings for Aurora Anterior Module 25
5 Imaging with Aurora 26
5.1 Retinal Module 27
5.2 Anterior Module 28
5.3 Aer imaging 29
6 Important information 30
6.1 Environmental conditions 30
6.2 Error messages 30
6.3 Cleaning 31
6.4 Service and repair 32
6.5 Battery 33
6.6 Disposal 34
6.7 Technical description 34
6.8 Electromagnetic compatibility 37
6.9 Compliance 41
6.10 Warranty 42
AAppendix - WLAN 43
A.1 Wireless settings 43
A.2 Optomed Client PC soware 44
Notes 45
Index 46
CONTENTS

6 Optomed Aurora
The information in this manual applies to the Optomed Aurora ophthalmic camera. The specifications in
this manual are subject to change without prior notice due to continuing product development. The latest
version of this manual can be downloaded at www.optomed.com/support where you can also find more
training materials.
This user manual explains the safety precautions and introduces the device and its proper operation. The
device must be used according to this user manual. The user manual and other documentation enclosed
with the Optomed Aurora should be kept accessible to users at all times to ensure that the information
required for use of the device is readily available.
CAUTION!
Read the user manual carefully before commissioning this device. It contains important information
regarding user and patient safety.
1.1 Symbols
The symbols used in this user manual or on device labels refer to important safety information
or manufacturing information. Whenever you see these symbols, read the accompanying information
carefully and observe all safety notes and information in this user manual and on device labels.
WARNING!
Indicates a hazardous situation which could result in patient injury, harm or death
if appropriate safety precautions are not followed.
CAUTION!
Indicates a situation which could result in device harm, damage or malfunction if
the appropriate precautions are not followed.
NOTE!
Important information: please read carefully.
1. Safety
|Safety

Optomed Aurora 7
European certificate of conformity
The CE marking with notified body identification numbering indicates the conformity
of 93/42/ EEC Medical Device Directive for class IIa devices and CE marking without
notified body identification numbering indicates the conformity of 93/42 EEC
Medical Device Directive for class I devices.
Read the instructions for use carefully
Failure to follow these instructions could place the patient or operator at risk.
Radio frequency radiation
The device has WLAN functionality. Electromagnetic interference may occur in
the vicinity of equipment.
FCC Declaration of conformity
The device emits RF radiation. Electromagnetic interference from the device is
under limits approved by the Federal Communications Commission.
Prescription device
Symbol for : “Caution: Federal law restricts this device to sale by or on the order
of a physician or licensed practitioner.”
Type BF applied parts
The eye cup which is in physical contact with the patient, is electrically isolated
and protected against electric shock.
Class II power supply
For indoor use only
Power supply designed primarily for indoor use only according to IEC 60417
Safety |

8 Optomed Aurora |Safety
Plug socket for power supply (Positive polarity)
Voltage and current
Disposal specification
European directive on waste electrical and electronic equipment (WEEE)
2012/19/EU specifies the disposal.
Battery disposal specification
The device has a rechargeable lithium-ion battery which can be recycled.
Manufacturer
The symbol is accompanied by the date of the manufacture, and the name and
the address of the manufacturer.
Serial number
The first four digits of the serial number indicates the week (digits 1-2) and year
(digits 3-4) of the manufacture.
Global trade item number
Reference number
GS1 Unique Device Identification
Keep away from water
REF

Optomed Aurora 9
Fragile
Handle with care.
Do not use hand hooks
Keep out of direct sunlight
Number of units packed
Temperature limitations
Humidity limitations
Atmospheric pressure limitations
Safety |

10 Optomed Aurora
1.2 Intended use
Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intend-
ed to capture images and video of the fundus of the eye and surface of the eye.
Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and
video of the fundus of the human eye.
Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and
video of the surface of the human eye and surrounding areas.
1.3 Contraindication
Optomed Aurora is classified as Group 2 based on standard ISO 15004-2:2007. The daily usage time and
maximum allowed number of pulses presented below is calculated on the basis of optical classification results.
WARNING!
The light emitted from this instrument is potentially hazardous. The longer the duration of exposure
and the greater the number of pulses, the greater the risk of ocular damage. Exposure to light
from this instrument when operated at maximum output will exceed the safety guideline aer:
Pulsed light
• 6300 still images / eye / day for Aurora Retinal Module
• 250 still images / eye / day for Aurora Anterior Module
Or alternatively continuous light
• 90 min video recording / eye / day for Aurora Retinal Module
• 8 min video recording / eye / day for Aurora Anterior Module
Please note that the exposure time in video recording and the number of pulses in still imaging from all
light sources are cumulative and additive. If the intensity of any of the light sources is reduced to half of
the maximum output, the exposure time or number of pulses for that light source to reach the exposure
safety guideline is doubled.
Since prolonged intense light exposure can cause ocular damage, the use of the device for ocular examination
should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to
provide clear visualization of the target structures. Infants, persons withaphakia or diseased eyes will be
at greater risk of ocular damage. The risk may also be increased if the person being examined has had any
exposure with the same instrument or any other ophthalmic instrument using a visible light source during
the previous 24 hours.
|Safety

Optomed Aurora 11
1.4 Precautions
WARNING!
Optomed Aurora is not suitable for use in explosion risk areas or in the presence of flammable
anesthetics.
WARNING!
Place the PC and Aurora Charging Station outside the patient environment (at a distance of at least
1.5 meters from the patient).
WARNING!
To avoid contamination, clean the eye cup before each use with a new patient.
WARNING!
Do not leave the eye cup in direct sunlight as it may heat up and cause burns.
WARNING!
In order to avoid touch current during imaging, do not touch the system connector and the
patient simultaneously.
CAUTION!
Optomed Aurora is intended for use inside, in normal room temperature, and normal humidity.
Do not use the device in an environment where there is a possibility of water condensation on or
inside the device.
CAUTION!
The device may only be used for the specified purpose and according to national regulations,
consistent with the applicable industry standards and occupational safety and accident prevention
regulations.
CAUTION!
Federal law restricts this device to sale by or on the order of a physician or licensed practitioner.
CAUTION!
No modification of this equipment is allowed.
CAUTION!
Only use accessories and battery provided by Optomed with this product.
Safety |

12 Optomed Aurora
CAUTION!
Only use USB cable and the power source provided by Optomed with this product.
If you need replacement USB cable or power source, please contact the manufacturer or your
local distributor. USB cable must be connected only to the USB port of a PC that complies with the
IEC 60950 standard. Only connect Aurora Charging Station to an electricity supply which corresponds
to the supply voltage of the device.
CAUTION!
Theconnection betweenthecameraand thePC isUSBand/orWLAN.Any authorizationproceduresshould
be carried out in the PC. If the PC is connected to a customer network, make sure the appropriate
safety measures are applied, such as Antivirus and Firewall protection.
CAUTION!
If there are breaks in device covers or other visual defects, contact Optomed Customer Service or
an Optomed-certified service facility.
CAUTION!
Repair and maintenance work may only be performed by authorized specialists. Contact your
Optomed representative for repairs and maintenance work on the device.
|Safety

Optomed Aurora 13
2. Device overview
Optomed Aurora is a modular ophthalmic camera that is designed for use in a medical environment. It is
intended to capture digital images and video of the fundus of the eye and surface of the eye for documentation
and consultation. Aurora Camera is used with interchangeable optics modules Aurora Retinal Module and
Aurora Anterior Module. Optics modules are attached to the camera with bayonet connectors.
Aurora Camera has a WLAN module which enables wireless data transfer to a PC. Captured images and
recorded videos can also be transferred to a PC via USB connection when the camera is placed on Aurora
Charging Station. In addition, Aurora Charging Station is a dual charger used for charging the battery inside
the camera and spare battery.
Aurora Retinal Module is intended for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis
is needed because infrared light is used for targeting the fundus and white light is flashed when an image
is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With
small pupils it is recommended to use mydriatic drops. Aurora Retinal Module has nine internal fixation targets
for the patient to fixate on during imaging. The middle fixation target provides a macula-centred image.
Aurora Anterior Module is intended for imaging the surface of the eye and surrounding areas. Aurora Anterior
Module has two light sources for imaging: white and cobalt blue. Cobalt blue light enables capturing of
fluorescent images. There are four focus windows to focus the image.
NOTE!
The device may only be operated by persons who have been properly trained or who have the
required knowledge and experience to do so. The device may only be used in accordance with
its intended use.
Device overview |

14 Optomed Aurora
Patient
Power button
Battery charging
indicator LED
Optoroller
WLAN indicator
Back button
Battery level
Dual action shutter
Eject button
Fixation target
Brightness level
Diopter value

Optomed Aurora 15
2.1 Controls and display icons
Battery level, WLAN, patient, fixation target, brightness level and diopter value indicators are shown on the
camera display.
Aurora Camera is powered on and o by pressing the power button. Opening the camera menu is done by
pressing Optoroller, which is also used for navigating in the menu together with back button.
Images are captured by pressing the dual action shutter. If the performance of Aurora Camera is abnormal,
it can be forced to shut down by pressing the power and back buttons simultaneously for seven seconds
or longer.
The battery charging indicator LED is on when the camera is placed on Aurora Charging Station for charging.
There is also an LED indicator in Aurora Charging Station for indicating spare battery charging.
Optics modules are detached by pressing the eject button on the top of the camera.
Device overview |
Power on Back button
Open camera menu and navigate
Shutter button for image capture Forced shutdown
Press eject button Detach the module

16 Optomed Aurora
3.1 Part list and unpacking
The Optomed Aurora sales package contains the
following items:
DEVICES
1. Camera
2. Retinal Module
3. Anterior Module
ACCESSORIES
4. Charging Station
5. USB Cable
6. Power Supply
7. Eye Cup (2 pcs)
8. Battery (2 pcs)
9. USB Flash Drive
10. Cleaning Cloth
11. User Manual and other material
Open the sales packaging. Remove Optomed Aurora and accessories from the sales package and check that
all parts are present and undamaged. Packaging materials should be retained for future relocation or repair.
3.2 Preparations
Place Charging Station (4) next to the PC. Charging Station must be outside the patient environment at a
distance of least 1.5 meters from the patient. Connect the USB cable (5) and the power supply cable (6)
to Charging Station and to the PC and to the mains.
3. Getting started
1.
2.
3.
4.
5. 6.
7.
8.
9.
10.
11.
|Getting started
NOTE!
Position the power supply so that the mains plug is easily disconnected.

Optomed Aurora 17
Both Retinal Module (2) and Anterior Module (3) are attached to Aurora Camera (1) by connecting firmly
the bayonet legs of the optics module to the bayonet holes of the camera. Avoid touching the camera lens
with bayonet legs in order to prevent scratches. To detach the optics module, press the eject button on the
top of the camera and take the camera and optics module apart.
Place the eye cup (7) on the optics ring of Aurora Retinal Module (2).
Install the battery (8) in Aurora Camera (1). Ensure that the camera is powered o when placing the battery.
Open the battery cover by sliding the battery cover release knob.
Insert the battery and press the cover firmly into place.
Place the camera on Charging Station (4) for charging. The camera will fit on Charging Station when Retinal
Module (2) is attached. Place the handle of the camera carefully onto the connector of Charging Station and
move the front part of the optics module onto the support. Excessive force should be avoided in order to
prevent the camera and Charging Station connectors from breaking. Aurora Camera is in power save mode
while placed on Aurora Charging Station and it is powered on when lied from Aurora Charging Station.
The battery charging indicator LEDs on the handle of the camera blink when the battery is being charged.
When the battery is fully charged, all indicator LEDs are lit. When charging for the first time, charge the
battery fully. In daily use, charge the battery when the battery level is low. Charging the battery at any level
is not harmful for the battery.
Getting started |

18 Optomed Aurora|Getting started
Aurora Charging Station can be used as an external charger for the spare battery. Set the spare battery (8)
connectors to the Charging Station (4) connectors and put the spare battery in place. The spare battery
charging indicator LED on Charging Station blinks when the battery is being charged, and is lit when the
spare battery is fully charged.
Remove Aurora Camera from Charging Station by first liing the optics module from the support and then
liing carefully the handle of the camera from the Charging Station connectors.
It is recommended to create a new study for each patient. A new study is created in the patients menu by
selecting the ‘New patient study’ item. It is also recommended that image data storage is always erased
between patients aer the images have been transferred to the PC.
If Aurora Camera is not used for more than two minutes, the device will go into power save mode. It is
powered on from power save mode by using any control button. Aurora Camera will power o if not used
for more than 10 minutes.
Aurora Camera has a WLAN module which enables wireless data transfer to the PC. The separate PC soware
needs to be installed on the PC to allow wireless data transfer. Instructions on the operation of wireless
settings and PC soware are in Appendix A.

Optomed Aurora 19
4.1 Quick menu
FOCUS
Change focus mode by selecting the focus item by pressing Optoroller and choose
either manual or autofocus. When focus mode is set to manual, a diopter scale is
shown on the screen and focus can be adjusted from –20 to +20 diopters.
Accept the selection by pressing Optoroller. In autofocus mode, the camera finds
correct focus automatically. The autofocus range is from -15 to +10 diopters.
BRIGHTNESS
Imaging light brightness for Aurora Retinal Module can be adjusted from 0 to 10
and the default value is 5. It is also possible to reduce the brightness setting below
1, to 0.8, 0.6, 0.4, and 0.2, if needed. To adjust brightness, select the brightness item,
choose a suitable value by turning Optoroller and press Optoroller to set the value.
For Aurora Anterior Module, it is possible to change the imaging LED between
white and blue. When the desired LED is selected, the imaging light brightness can
be adjusted from 0 to 10 in a similar way as described above.
PATIENTS
In the patients menu , it is possible to create a new study for images, to preview
captured images or to select four image sequence (only when Optomed Aurora
Retinal Module is used).
A new study is recommended for each patient. Select the ‘ New patient study ’ item
by pressing Optoroller to create a new study. An anonymous study is created for
the patient unless there is a patient list where you can select the patient by
using Optoroller. A patient can also be deleted from the patient list.
When Aurora Camera is powered on, enter the
menu by either pressing or rotating Optoroller.
To move between menu items, turn Optoroller to
the le or right. Press Optoroller to select the item.
Exit the menu level by pressing the back button.
4. Features
Features |

20 Optomed Aurora
Select the ‘ Image browser’ item by pressing Optoroller to preview captured images.
To view the latest captured images in current patient study, select ‘ IMG ’. If you want
to preview images from other studies, select first the study/patient whose images
you wish to preview. Then select the desired image from the selected study by
using the Optoroller. When the image is shown, the image can be zoomed by
pressing the Optoroller. It is also possible to delete complete studies or
single images.
When imaging with Optomed Aurora Retinal Module, there is a possibility to select
the ‘ Four image sequence ’ item by pressing Optoroller. By selecting four image
sequence, a new patient study is created and the camera will guide to take both
macula and disc centered images from patient’s right and le eyes. Aer each
capture, the image can be zoomed, retaken or you can choose to continue to the
next sequence.
TARGET LEDS FOR AURORA RETINAL MODULE
Optomed Aurora Retinal Module has nine internal fixation targets for the patient to
fixate on during imaging. The middle fixation target is on by default and it provides a
macula centred image. To change the fixation target, select the target LEDs item, then
turn Optoroller le or right to choose the suitable LED and press Optoroller to set the
fixation target.
FOCUS WINDOWS FOR AURORA ANTERIOR MODULE
Optomed Aurora Anterior Module has four focus windows for the user to focus
the image on dierent areas during autofocus imaging. The right focus window is
selected by default and the image is focused to the right side. To change the
focus window, select the focus window item, then turn Optoroller le or right to
choose a suitable area and press Optoroller to set the focus window area.
SETTINGS
To change camera- or optics-specific settings, select the ‘ Settings’ item by pressing
Optoroller. Camera- and optics-specific settings are described in the following
chapters.
|Features