Varex Imaging Optica 30 Series User manual

TM50567, Revision: 4.0
www.vareximaging.com
0120
Optica 30/40/50 series
Technical Manual
Optica 30
Optica 40
Optica 50

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 2/56 www.vareximaging.com
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Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 3/56 www.vareximaging.com
Table of Contents
1. Introduction........................................................................................................................................5
Contact information .................................................................................................................5
Abbreviations ..........................................................................................................................6
Symbols used in this document ..............................................................................................7
Advisory...................................................................................................................................7
Radiation danger.....................................................................................................................7
General warnings, cautions and notes....................................................................................8
Labels and markings on the device ..................................................................................... 10
Supplied components........................................................................................................... 12
2. Device description .......................................................................................................................... 13
Intended use ........................................................................................................................ 13
Description of the collimator................................................................................................. 13
Principle of operation ........................................................................................................... 14
Overview of the collimator.................................................................................................... 14
Main dimensions .................................................................................................................. 16
Aluminum equivalent............................................................................................................ 17
Restrictions on use............................................................................................................... 17
Essential Performance ......................................................................................................... 17
Applied parts ........................................................................................................................ 17
Known contraindication(s).................................................................................................... 17
Classifications ...................................................................................................................... 17
3. Installation ...................................................................................................................................... 18
Requirements for service personnel .................................................................................... 18
Installation requirements ...................................................................................................... 18
Installation instructions......................................................................................................... 18
Installer responsibilities ........................................................................................................ 18
Remove and re-mount the rear cover .................................................................................. 18
Installation of cables............................................................................................................. 19
Mounting a DAP meter......................................................................................................... 21
Mounting the collimator to the X-ray tube ............................................................................ 22
Calibration and collimator setup........................................................................................... 25
X-ray beam Alignment.......................................................................................................... 31
Collimator Adjustments ........................................................................................................ 32
4. Electrical specification .................................................................................................................... 33
Fuses.................................................................................................................................... 33
Power Supply ....................................................................................................................... 33
Mains isolation................................................................................................................................ 33
Earthing................................................................................................................................ 33
CAN interface....................................................................................................................... 33
Housing interface ................................................................................................................. 33
EMC compatibility ................................................................................................................ 34
4.6.1. Deviations ...................................................................................................................... 34
4.6.2. Allowances..................................................................................................................... 34
4.6.3. Precautions.................................................................................................................... 34
4.6.4. Emissions Compliance .................................................................................................. 35
4.6.5. Immunity Compliance .................................................................................................... 35
5. Operating instructions .................................................................................................................... 38
Powering ON and OFF......................................................................................................... 38
Status LED color .................................................................................................................. 40
Functions during OPERATING MODE................................................................................. 40

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 4/56 www.vareximaging.com
6. Maintenance................................................................................................................................... 41
Cleaning ............................................................................................................................... 41
Cleaning procedures and agents ................................................................................................... 41
Cleaning recommendations ........................................................................................................... 41
Preventive checks ................................................................................................................ 41
Maintenance interval ............................................................................................................ 42
Maintenance checks ............................................................................................................ 42
Necessary recurrent maintenance and/or testing ................................................................ 42
Removal from host system................................................................................................... 42
7. Troubleshooting and service .......................................................................................................... 43
Troubleshooting, fault diagnosis .......................................................................................... 43
Error codes........................................................................................................................... 44
CAN protocol configuration .................................................................................................. 45
Varex Imaging Nederland B.V. protocol and Service protocol ............................................. 45
8. Disposal.......................................................................................................................................... 52
9. Specifications and accessories ...................................................................................................... 53
Technical specifications........................................................................................................ 53
Product label ........................................................................................................................ 54
Figure 1 Rear cover screws................................................................................................................... 19
Figure 2 Collimator power supply cable and CAN cable installation..................................................... 20
Figure 3 Green CAN bus connector ...................................................................................................... 21
Figure 4 DAP meter installation............................................................................................................. 22
Figure 5 Mounting the Collimator to the X-ray tube .............................................................................. 23
Figure 6 Distance from X-ray tube focal point to collimator mounting plane......................................... 24
Figure 7 Flange lock .............................................................................................................................. 25
Figure 8 Field light adjustment .............................................................................................................. 32
Figure 9: rear view (product label)......................................................................................................... 54
Figure 10: Product label for Optica 40................................................................................................... 55
Figure 11: Product label for Optica 30/50.............................................................................................. 55
All rights reserved
Although this guide is prepared with utmost care, Varex Imaging Nederland B.V. assumes no
responsibility for errors or omissions.
Varex Imaging Nederland B.V. cannot be held accountable for damages of any nature arising from the
use, and / or use of any options other than original Varex Imaging Nederland B.V. products.
Warranty
The product has the warranty provisions of our general conditions.
The warranty on your equipment will be void if:
•Service and maintenance are not carried out according to the instructions and if repairs are
not performed, or performed without proper validation.
•Changes or modifications made without our prior written consent.
•Non-original parts or other than the specified lubricants have been used.
•The equipment has been used improperly, carelessly or not in accordance with its nature and /
or purpose.
All consumables (e.g. bolts, nuts, screws, etc.) are excluded from warranty

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 5/56 www.vareximaging.com
1.Introduction
Contact information
This manual provides all the technical information necessary for the correct installation, application
and maintenance of the Collimator
This document is accompanying the Optica 30/40/50 series (see also §1.7). Additional to this
Technical Manual a User Manual is supplementary to the INSTRUCTIONS FOR USE.
If you need additional information, need support or want to report a problem with the Collimator,
please contact your distributor or Varex Imaging Nederland B.V.:
Manufacturer
Distributor
Name
Varex Imaging Nederland B.V.
Address
Anholtseweg 44,
7091 HB Dinxperlo
The Netherlands
Telephone
[phone]
Fax
[phone]
E-mail
[e-mail]
Website
www.vareximaging.com
For support and service purposes, please note the following information:
Model name:
Optica 30/40/50 series
Part number:
Serial number:
Software versions:
Main
Display
(not applicable for Optica 30 and
Optica 50)
Model name, Part number and Serial number can be found on the product label, see §9.2
Optica 40: Software versions can be found in Service screen 3, see §3.9
Optica 30/40/50: Software versions can be found via CAN bus protocol, see §7.4

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 6/56 www.vareximaging.com
Abbreviations
Term
Definition
CAN bus
Controller Area Network bus.
A communication network that allows remote control of the collimator.
EMC
Electromagnetic compatibility
ESD
Electro Static Discharge
ME
Medical Equipment
Optica 30
X-ray Collimator Optica 30 series
Optica 40
X-ray Collimator Optica 40 series
Optica 50
X-ray Collimator Optica 50 series
PCB
Printed Circuit Board.
SID
Source to Image Distance.
The distance from the source of radiation (the focal spot of the x-ray tube) to the film or
other image-receptor.
Synonym: Focal Film Distance (FFD).
SIP/SOP
SIGNAL INPUT/OUTPUT PART
part of ME EQUIPMENT, not being an APPLIED PART, intended to deliver or receive
signals to or from other electrical equipment, for example, for display, recording or data
processing
This document contains terminology and definitions based on (international) standards. The
terminology and definitions are formatted in capital letters (e.g. INTENDED USE). Terminology and
definitions from the following standards are used:
Reference
Title
IEC 60601-1
Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2
Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromagnetic disturbances
– Requirements and tests
IEC 60601-1-3
Medical electrical equipment – Part 1-3: General requirements for basic safety
and essential performance – Collateral Standard: Radiation protection in
diagnostic X-ray equipment
IEC 60601-2-54
Medical electrical equipment – Part 2-54: Particular requirements for the basic
safety and essential performance of X-ray equipment for radiography and
radioscopy
IEC 62366
Medical devices - Application of usability engineering to medical devices

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 7/56 www.vareximaging.com
Symbols used in this document
To ensure adequate and clear understanding of the information provided in this manual, the symbols
listed below are used to indicate warnings, cautions, actions and notes that are important for correct
and safe use of the Collimator.
WARNING:
Warnings are directions which, if they are not followed, can cause fatal or serious injuries
to a user, engineer, patient or any other person or can lead to a mistreatment.
CAUTION:
Cautions are directions which, if they are not followed, can cause damage to the
Collimator described in this manual or any other equipment or goods and can cause
environmental pollution.
NOTE:
Notes provide advice and highlight unusual points. A note is not intended as an
instruction.
Advisory
This manual must be read and understood by the users as defined in the INTENDED USE (see
section §2.1) and SERVICE PERSONNEL.
This manual must be made available to the users and SERVICE PERSONNEL.
The users and service personnel must verify that all requirements according to the safety standards
and regulatory legislation are met before use of the Optica 30/40/50 series.
Host system marking and/or certification (e.g. CE-marking, NRTL certification, etc.) can be affected by
installation of the Optica 30/40/50 series. Please consult the manufacturer of the host system for
advice on installation of the Optica 30/40/50 series.
Information regarding accidents that have occurred using the Optica 30/40/50 series must be reported
to Varex Imaging Nederland B.V. immediately.
Varex Imaging Nederland B.V. is not liable if the provided instructions are not complied with. Varex
Imaging Nederland B.V. is not liable if one or more of the following cases apply:
•Modification or repairing of the Optica 30/40/50 series in any way other than described in this
manual.
•Installation of the Optica 30/40/50 series which is not in accordance with the installation
instructions as provided.
•Use of the Optica 30/40/50 series other than the INTENDED USE.
•Installation of the Optica 30/40/50 series by SERVICE PERSONNEL that is not qualified.
•The Optica 30/40/50 series is not subjected to regular inspection and maintenance.
•Use of the Optica 30/40/50 series in a way which could not be reasonable foreseen by Varex
Imaging Nederland B.V..
•Direct or indirect damage which are caused by not following the procedures and instructions in
this manual.
Radiation danger
The Optica 30/40/50 series are designed and manufactured according applicable standards to meet
the safety legislation. However due to inherent radiation danger which cannot be eliminated, it is
crucial to follow all safety procedures and instructions. To minimize the inherent danger of radiation, all
procedures and instructions must be followed by the users and SERVICE PERSONNEL.
The user and SERVICE PERSONNEL must ensure that all possible measures are taken to ensure
health and safety of patient and user.

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 8/56 www.vareximaging.com
General warnings, cautions and notes
WARNING: The collimator is intended to be mounted to an X-ray system that can be
installed in an X-ray room, which has its own restrictions and safety measures specific to
protect against ionizing radiation. Follow local and hospital regulations and instructions.
WARNING: This manual identifies the elements of safety and operating instructions that
must be followed by the organization that mounts the collimator to an X-ray system.
Follow and apply instructions to ensure the safe and proper operation of the collimator.
Use the instructions for use of the X-ray system that will be used in combination with the
collimator for identification of any training related to the combined use of the collimator
and the X-ray system.
WARNING: Do not use the collimator for other use than is described in the intended use
section. Any other use is considered as "Improper Use”.
WARNING: Do not modify this equipment without authorization of the manufacturer.
Any change or modification carried out by unauthorized personnel may introduce serious
hazards. When changes or modification are carried out by unauthorized personnel,
Varex Imaging Nederland B.V. cannot be held responsible for injuries or damage to
equipment.
WARNING: Disconnect power supply before opening collimator.
WARNING: Do not use the collimator if the status LED is colored red.
WARNING: Do not use the collimator if the status LED or the light field projection is of
low luminance.
WARNING: Be aware that the light intensity level must be according to local regulations.
WARNING: Possibly hazardous optical radiation emitted. The collimator contains field
light power LED of Risk Group 2. Do not stare at operating lamp. May be harmful to the
eyes.
Be extra careful with unconscious patients because they cannot blink their eyes to
protect their eyes to the light source.
WARNING: The collimator contains a Class 1 laser or Class 2. (Depending on optional
feature) Do not stare into the laser beam
Be extra careful with unconscious patients because they cannot blink their eyes to
protect their eyes to the light source.
WARNING: Always monitor the patient when the collimator is in use.
WARNING: The light field source inside the collimator becomes hot.
WARNING: The device contains sensitive electronics. Ensure that ESD protective
measures are in place when the device is installed or serviced to prevent damage to the
device.

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 9/56 www.vareximaging.com
WARNING: To avoid the risk of electric shock, this equipment must only be connected to
protective earth.
WARNING: Use of components and accessories other than those specified in this
Technical Manual may lead to unexpected performance of the collimator.
WARNING:
The temperature of the enclosure can become more then 41 °C
CAUTION: Do not use the collimator if any part is damaged, is making noise or vibrates.
CAUTION: Do not use the collimator in oxygen-rich environments, and/or in presence of
flammable gases.
CAUTION: The collimator is not intended for sterilization.
CAUTION: The collimator is powered through an external power supply at 24 V DC.
CAUTION: If the enclosure is mechanically damaged DO NOT USE. In case of doubt,
before taking any action, please contact your distributor or Varex Imaging Nederland
B.V..
NOTE:
Always keep this manual and read it before using the collimator.
NOTE:
Please contact your distributor or Varex Imaging Nederland B.V. when the product label
or other markings on the outside of the collimator are missing.
Requirements for SERVICE PERSONNEL
The device may only be installed, repaired or serviced by qualified SERVICE PERSONNEL, i.e.:
•Authorized by the RESPONSIBLE ORGANIZATION of the device;
•Authorized by the manufacturer;
•In possession of the diploma’s / certificates required by national and local legislation.
WARNING:
Service, maintenance and adjustments may only be executed by qualified SERVICE
PERSONNEL.

Technical Manual: TM50567
Optica 30/40/50 series
Revision: 4.0
Date of release: 2019-01-23 10/56 www.vareximaging.com
Labels and markings on the device
Symbol
Explanation
Manufacturer
Date of manufacture
Serial number
Catalogue number.
0120
CE-mark directive 93/42/EC; conformity assessment by notified body 0120
(optional feature)
710383
SGS recognized component for US & Canada, registration number 710383
(optional feature)
Identification of compliance with FCC 47 CFR Part 15 (optional feature)
CAUTION: Federal law restricts this device to sale by or on the order of a
physician. (optional feature)
Identification of compliance with the provisions for EU WEEE directive
DC supply voltage indication.
Protective earth.
Follow the instructions for use
Reading the instructions for use is crucial for a correct and safe use of the
collimator
Warning: Laser emission, possibly hazardous optical radiation emission
(optional feature)
Warning: Identifies the exit point of the laser beam (optional feature)
Explanatory warning for hazardous optical radiation
Explanatory warning for laser radiation (optional feature)
OVERTURE
LASER
APERTURE
GROUPE DE RISQUE 2
RISK GROUP 2
ATTENTION. Il est possible que ce produit émette
des rayonnements optiques dangereux.
Ne pas fixer la lampe pendant son fonctionnement.
Cela comporte un risque pour les yeux.
CAUTION. Possibly hazardous optical radiation
emitted from this product.
Do not stare at operation lamp.
May be harmful to the eyes.