Varex Imaging Optica 30 Series User manual

UM50566-EN, Revision: 3.0
www.vareximaging.com
0120
Optica 30/40/50 series
User Manual
Optica 30
Optica 40
Optica 50

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 2/36 www.vareximaging.com
Table of Contents
1. Introduction........................................................................................................................................4
1.1. Contact information .................................................................................................................4
1.2. Symbols used in this document ..............................................................................................4
1.3. Abbreviations ..........................................................................................................................5
1.4. Advisory...................................................................................................................................5
1.5. Radiation danger.....................................................................................................................5
1.6. General warnings, cautions and notes....................................................................................6
1.7. Labels and markings on the device ........................................................................................7
1.8. Supplied components........................................................................................................... 10
2. Device description ...........................................................................................................................11
2.1. Intended use .........................................................................................................................11
2.2. Description of the Collimator .................................................................................................11
2.3. Essential Performance ..........................................................................................................11
2.4.Principle of operation ............................................................................................................11
2.5. Known contraindication(s).................................................................................................... 12
2.6. Restrictions on use............................................................................................................... 12
2.7. Overview of the collimator.................................................................................................... 12
2.8. Bucky laser........................................................................................................................... 13
2.9. Applied parts ........................................................................................................................ 13
2.10. Accessories.......................................................................................................................... 13
2.11. Classifications ...................................................................................................................... 14
3. Operating instructions .................................................................................................................... 15
3.1. Powering ON and OFF......................................................................................................... 15
3.2. Status LED color .................................................................................................................. 17
3.3. Error codes and troubleshooting.......................................................................................... 18
3.4. Collimator functions during OPERATING MODE................................................................. 19
3.5. EMC compatibility ................................................................................................................ 27
4. Troubleshooting, maintenance and service ................................................................................... 28
4.1. Troubleshooting.................................................................................................................... 28
4.2. Cleaning ............................................................................................................................... 28
Cleaning procedures and agents ................................................................................................... 28
Cleaning recommendations ........................................................................................................... 28
4.3. Maintenance and service ..................................................................................................... 28
4.4. Safety precautions ............................................................................................................... 28
5. Disposal.......................................................................................................................................... 29
5.1. Disposal................................................................................................................................ 29
6. Technical specification.................................................................................................................... 30
6.1. Product label ........................................................................................................................ 31

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 3/36 www.vareximaging.com
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.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 4/36 www.vareximaging.com
1.Introduction
1.1. Contact information
Dear Customer, thank you for choosing a Collimator that is designed, manufactured and marketed by:
Varex Imaging Nederland B.V.
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
This user manual is applicable for the Optica 30/40/50 Series,
Series
Touchscreen
Control knobs
Status LED
Light button
30
-
x
x
x
40
x
x
x
x
50*
-
-
-
-
x means that this feature is present, - means that this feature is absent
*The Optica 50 series is meant for remote control only.
1.2. 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 device
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.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 5/36 www.vareximaging.com
1.3. Abbreviations
Term
Definition
EMC
Electromagnetic compatibility
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).
RF
Radio Frequency
Collimator
Optica 30/40/50 series (X-ray Collimator)
1.4. 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 must verify that all requirements according to the safety standards and regulatory legislation
are met before use 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.
•Use of the Optica 30/40/50 series other than the INTENDED USE.
•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.
1.5. 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.
The user must ensure that all possible measures are taken to ensure health and safety of patient and
user.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 6/36 www.vareximaging.com
1.6. 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 organisation 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: 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 or Class 2 laser. (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:
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Optica 30/40/50 series, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
WARNING:
When there is any damage to the collimator or repair is needed, only original
replacement parts shall be used. Contact your distributor or Varex Imaging Nederland
B.V. for assistance.
WARNING: Always monitor the patient when the collimator is in use.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 7/36 www.vareximaging.com
WARNING:
The temperature of the enclosure can become more then 41 °C
WARNING:
If the collimator is used in an X-ray system with an automatic exposure control, verify
before operation if the selected measuring cell is within the diagnostic (collimated) area.
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.
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.
1.7. 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)

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 8/36 www.vareximaging.com
Symbol
Explanation
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)
Indication cross shutters
Indication long shutters
Operate field light indicator (Optica 30/40 series only)
Manual Control.
Automatic Control.
Additional filtering.
Bucky laser ON indicator
Symbol to indicate the selected image field size.
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.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 9/36 www.vareximaging.com
Symbol
Explanation
Tilting angle.
Setup collimator.
<<
Return to previous screen.
Accept numeric keyboard value.
Cancel numeric keyboard value.
<
Delete entered digit on numeric keyboard.
Restart collimator.
>>
When displayed in an error message:
Continue to use the collimator with limited functionality

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 10/36 www.vareximaging.com
1.8. Supplied components
The device that you have purchased is packed in a transport packaging appropriately designed to
ensure the integrity of the device. Please ensure that the package you received is intact and that there
are no traces of moisture or visual damages to the device. Otherwise, you should immediately contact
your distributor or Varex Imaging Nederland B.V.. It is highly recommended to always use the original
packaging during transport and for return shipments. See §6 for storage conditions if the device is not
used directly.
The packaging contains the following components:
Amount
Description
Reference
1
Optica 30/40/50
series
CF002 : Configuration with automatic
filters
CF004 : Configuration without automatic
filters
50126-2N-LLL1
50127-2N-LLL
50129-2N-LLL
50133-2N-LLL
50146-2N-LLL
50149-2N-LLL
1
Document Kit
Contains:
•1 User Manual
•1 Technical Manual
•1 ECDoC (= Declaration of
Conformity)
50611-LLL
1
Accessory kit
Content is depending on the series
1
The catalogue number contains “2N-LLL”, which stands for a sequel number to define the
configuration within the applicable model, e.g. laser, different front sticker, color, etc. LLL
implicates regional versions.
The main functionality and information is applicable to all sequel numbers within the mentioned
catalogue number.
Be advised by your distributor or Varex Imaging Nederland B.V. for any accessories available.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 11/36 www.vareximaging.com
2.Device description
2.1. Intended use
The device is intended to be used in medical diagnostic applications with restrictions to human
diagnostics. The device is intended to be used as accessory of an X-ray system in a professional
healthcare facility environment. The device is intended to restrict the dimensions of a diagnostic X-ray
field by limiting the primary X-ray beam. The limitations of use are specified in §6. The device is not
intended to be used in fluoroscopy applications; near active HF Surgical Equipment or in the RF
shielded room of a system for magnetic resonance imaging, where the intensity of Electromagnetic
Disturbances is high.
Use, other than above, is identified as abnormal use.
The intended user of the device is defined as the operator of an X-ray system. The operator shall be
qualified and/or trained to operate the X-ray system.
2.2. Description of the Collimator
The collimator is an automatic, square-field, multi-leaf, X-ray collimator and is suitable for installation
on stationary X-ray equipment.
The X-ray field is limited by 4 pairs of shutters which are covered with lead.
Two pairs of lead shutters are located near the focus of the X-ray beam; two pairs are located near the
exit window of the collimator. The latter shutters serve to accurately define the X-ray field edges.
The X-ray field can be adjusted manually with the two knobs on the collimator front panel (Optica
30/40 Series only) or remotely.
The field size can be selected with SID and field dimension input (see § 3.1)
In automatic mode, the field size is kept regardless of the set SID.
2.3. Essential Performance
The Optica 30/40/50 series does not have essential performance.
2.4. Principle of operation
The collimator field dimension is established by 4 pairs of lead covered shutters that can be positioned
through the control knobs (Optica 30/40 Series only) on the front of the collimator. The following
symbols are used to indicate each shutter pair:
Symbol
Definition
Description
Cross shutters
The bold lines indicate the shutter pair seen from
the top-side of the collimator.
Long shutters
Operate light field
Symbol used to indicate the light button switch.
Press the button to activate the light which will
indicate the X-ray diagnostic area.
Operate laser line(s) (optional)
(optica 40 only)
Symbol used to indicate the laser button switch.
Press the button (on touch screen) to activate the
single line laser.
Additional filtration (optional)
(optica 40 only)
Additional filtration can be selected by pressing
the button (on touch screen) to change filtration

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 12/36 www.vareximaging.com
2.5. Known contraindication(s)
Contraindications of the X-ray system continue to apply (see X-ray system documentation).
Additional the Optica 30/40/50 series introduces matter in the primary X-ray beam which primarily
results in additional X-ray scatter. Additional X-ray scatter causes a radiation risk. The Optica 30/40/50
series is mitigating the radiation risk by shielding the additional scatter and limiting the size of the
primary X-ray beam and also confining the scatter generated from the X-ray tube (housing).
2.6. Restrictions on use
RF communication devices should be kept at a minimum distance of 30 cm. Otherwise the
performance of the device can be negatively influenced.
2.7. Overview of the collimator
A
Fixing flange
B
Control knob, Cross shutters (Optica 30/40 Series only)
C
Control knob, Long shutters (Optica 30/40 Series only)
D
Enclosure
E
Status LED (Optica 30/40 Series only)
F
Push button for activation of the Light field and the Bucky laser (Optica 30/40 Series only)
G
Measuring tape, for determining the SID.
Pull out the end hook and place it against the designated surface (e.g. table, wall stand, etc.).
Read the SID size at the measuring tape aperture of the enclosure front.
H
Bucky laser shutter to close the laser aperture, see §2.8
I
Accessory rails, for a maximum of 2 accessories with a width of 177 mm
J
Accessory lock, for locking the accessory
Prior to inserting accessories in the accessory rails check the fit and locking.
Hazard of falling accessory.
K
Touch screen (Optica 40 Series only)

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 13/36 www.vareximaging.com
Use of the measuring tape:
The type of measuring tape used is a standard measuring tape. The tape used in the
collimator starts with values that correspond to the focus/collimator lower edge distance;
maximum measurement with the tape is 2 m.
Forcing and/or extending the tape beyond this point could cause the following
inconveniences:
•Breakage of the tape or,
•Distortion of the tape or,
•Impossibility of retracting the tape into its housing.
NOTE: Do not extend the tape beyond the indication of 2.0 m
NOTE: High speed release of the tape might damage the tape
2.8. Bucky laser
A representation of the Bucky laser line is depicted below. The dimension and location of the line
varies with the SID.
2.9. Applied parts
The Optica 30/40/50 series do not have applied parts.
2.10. Accessories
Be advised by your distributor or Varex Imaging Nederland B.V. for any accessories available.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 14/36 www.vareximaging.com
2.11. Classifications
Subject
Classification
Reference
Electrical safety classification
Class I
IEC 60601-1
Applied Part
Not applicable
IEC 60601-1
Mode of operation
Continuous operation
IEC 60601-1
Ingress protection classification
IP20
IEC 60529
Laser classification
Class 2
IEC 60825-1
Field light classification
Risk Group 2
IEC 62471
Not intended for use in Oxygen Rich environment.
Not suitable for Sterilization.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 15/36 www.vareximaging.com
3.Operating instructions
3.1. Powering ON and OFF
POWER ON:
When the power supply to the collimator is switched ON, the collimator performs a power-ON
self-test for important functions of the collimator. During the power-ON self-test (which takes a
few seconds), the status LED is flashing green (Optica 30/40 Series only).
A Start-Up screen is displayed on the touch screen (Optica 40 Series only).
The result of the power-ON self-test can be:
Successful:
The color of the status LED is green (not flashing) (Optica 30/40 Series only), additional
filtering is not applied and the shutters are completely closed. The Main screen is shown
(Optica 40 Series only)
The collimator is ready for use and is now in OPERATING MODE.
Not successful:
A fault condition is detected during the power-ON self-test and the color of the status LED
is red (Optica 30/40 Series only). The collimator is not ready for use and is now in ERROR
MODE. Some fault conditions could permit limited use of the collimator. This is however
not advised. See ERROR MODE and §3.3 for more details about error messages.
An error popup window is shown (Optica 40 Series only), see figure below.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 16/36 www.vareximaging.com
OPERATING MODE:
This is the normal operating mode of the collimator. This mode is entered either through a
successful POWER ON (fully functional) or after accepting a fault condition (partly functional).
The color of the status LED is green (Optica 30/40 Series only). See §3.4 for more details
about the functionality that is available during OPERATING MODE.
ERROR MODE:
When a fault condition is detected, this mode is entered. The color of the status LED is red
(Optica 30/40 Series only). The fault conditions are indicated by a number and explained in
§3.3.
The collimator shows a popup error message on the touch screen (Optica 40 Series only).
WARNING: only the first detected fault condition is displayed on the touch screen.
WARNING: It is important to send the following information to Varex Imaging Nederland
B.V. for analysis:
•Error code. When the warning symbol close to the setup button is
displayed, the last displayed error message can be viewed again by
selecting the warning symbol.
•Version of the display software (Optica 40 Series only), contact a service
engineer.
•Version of the control software; contact a service engineer.
POWER-OFF:
There is no shutdown procedure for the collimator. The collimator can be switched OFF at any
time without damaging the collimator by switching OFF the power supply to the collimator.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 17/36 www.vareximaging.com
3.2. Status LED color
The status LED indicates the Collimator modes (Optica 30/40 Series only). The table below explains
the status LED indications.
During the POWER-ON self-test and normal OPERATING MODE, the collimator software can detect
fault conditions see §3.3
Collimator
Mode
Color of the
status LED
Explanation of the color indication
POWER ON
Green,
Flashing,
50% OFF
50% ON
No fault condition, the collimator is performing its power-ON self-
test.
OPERATING
MODE
Green
Collimator performs as expected.
ERROR
MODE
Red
or
Green,
flashing,
90% OFF
10% ON
A fault condition is detected. The collimator is not able to perform
as expected, see §3.3

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 18/36 www.vareximaging.com
3.3. Error codes and troubleshooting
The table below shows error codes and actions for troubleshooting. For Optica 40 series the codes
are displayed on the touch screen.
Error code
Description
Troubleshooting
1 - 49
POWER ON self-test fault.
Restart the collimator by selecting in
the fault condition message.
If the error persists do not use the collimator,
contact service engineer.
50, 51, 52
Internal memory fault.
53
Data memory is unexpectedly loaded
with default values.
WARNING:
Contact a service engineer to
check the collimator.
Do not use the Collimator until re-calibration
is performed.
60
Internal communication fault.
Restart the collimator by selecting
in the fault condition message.
If the error persists do not use the collimator,
contact service engineer.
70
Long and/or cross shutter sensor(s)
fault.
Restart the collimator by selecting in
the fault condition message.
If the error persists do not use the collimator,
contact service engineer.
For use of the collimator with limited
functionality, select , see ERROR
MODE in §3.1
100
Lower filter sensor(s) fault.
Restart the collimator by selecting in
the fault condition message.
101
Upper filter sensor(s) fault.
102
Lower filter positioning timeout fault.
If the error persists, contact
service engineer. Do not use this
Collimator until error solved.
103
Upper filter positioning timeout fault.
104
Lower and/or upper filter fault while
filters are not expected to move.
200
Light field and Bucky laser activation
button stuck.
Restart the collimator by selecting in
the fault condition message.
If the error persists, the collimator can be
used with limited functionality. Use button on
touch screen.
Contact service engineer.

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 19/36 www.vareximaging.com
3.4. Collimator functions during OPERATING MODE
Optica 40 Series only
Example for pre-set selecting SID to 100 cm

User Manual: UM50566-EN
Optica 30/40/50 series
Revision: 3.0
Date of release: 2019-01-09 20/36 www.vareximaging.com
Example for manually selecting SID to 110 cm