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