Varex Imaging Claymount Optica 10 Series User manual

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UM50735-EN, Revision: 12
1639
Optica 10 series
User Manual

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 2/28 www.vareximaging.com
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User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 3/28 www.vareximaging.com
Table of Contents
1. Introduction...................................................................................................................................................6
1.1. Contact information ............................................................................................................................6
1.2. Abbreviations, acronyms and definitions ...........................................................................................6
1.3. Symbols used in this document .........................................................................................................7
1.4. Advisory..............................................................................................................................................7
Radiation danger ..........................................................................................................................................7
1.5. General warnings, cautions and notes...............................................................................................8
1.6. Labels and markings on the device ...................................................................................................9
1.7. Supplied components.......................................................................................................................11
2. Device description ......................................................................................................................................12
2.1. INTENDED USE ..............................................................................................................................12
2.2. Description of the device..................................................................................................................12
2.3. Principle of operation .......................................................................................................................13
2.4. Overview of the device.....................................................................................................................13
2.5. Main dimensions ..............................................................................................................................16
2.6. Aluminum equivalent........................................................................................................................16
2.7. Restriction on use ............................................................................................................................16
2.8. ESSENTIAL PERFORMANCE ........................................................................................................16
2.9. APPLIED PARTS .............................................................................................................................16
2.10. Known contraindication(s)................................................................................................................16
2.11. Classifications ..................................................................................................................................17
2.12. Installation ........................................................................................................................................17
3. Operating instructions ................................................................................................................................18
3.1. Switching the device ON and OFF...................................................................................................18
3.2. Status LED color ..............................................................................................................................18
3.3. Device features ................................................................................................................................19
3.4. Adjustments .....................................................................................................................................21
3.5. EMC compatibility ............................................................................................................................22
4. Troubleshooting, maintenance and service ...............................................................................................23
4.1. Troubleshooting................................................................................................................................23
4.2. Cleaning ...........................................................................................................................................23
Cleaning procedures and agents ...............................................................................................................23
Cleaning recommendations .......................................................................................................................23
4.3. Maintenance and service .................................................................................................................23
5. Disposal......................................................................................................................................................24
6. Specifications and accessories ..................................................................................................................25
6.1. Technical specifications....................................................................................................................25
6.2. Product label ....................................................................................................................................26
6.3. Accessories......................................................................................................................................27

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 4/28 www.vareximaging.com
Figure 1: Device, Front view..............................................................................................................................13
Figure 2: Device, Bottom view...........................................................................................................................14
Figure 3: Accessory rail specification ................................................................................................................15
Figure 4: Main dimensions ................................................................................................................................16
Figure 5: Shutter control....................................................................................................................................19
Figure 6: Laser shutter(s) ..................................................................................................................................20
Figure 7: Filter module.......................................................................................................................................21
Figure 8: Back view (product label) ...................................................................................................................26
Figure 9: Product label ......................................................................................................................................27

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 5/28 www.vareximaging.com
All rights reserved
Although this manual is prepared with utmost care, Varex Imaging Nederland B.V. cannot be held
accountable 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.
The Optica 10 series contains features which are model type specific, the appearance of the device depends
on the configuration and may differ to the images in this document.
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 UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 6/28 www.vareximaging.com
1.Introduction
This document is accompanying the Optica 10 series (see also §1.7). Additional to this User Manual a
Technical Manual is supplementary to the INSTRUCTIONS FOR USE.
1.1. Contact information
This manual provides all the technical information necessary for the correct installation, application,
operation, maintenance and service of the device.
If you need additional information, need support or want to report a problem with the device, please contact
your distributor or Varex Imaging Nederland B.V.:
Manufacturer
Distributor
Name
Varex Imaging Nederland B.V.
Address
Fabriekstraat 41,
7005 AP Doetinchem,
The Netherlands
Telephone
[phone]
Fax
[phone]
E-mail
[e-mail]
Website
www.vareximaging.com
1.2. Abbreviations, acronyms and definitions
Term
Definition
Collimator
X-ray Collimator Optica 10 series
Optica 10
X-ray Collimator Optica 10 series
SID
Source 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

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 7/28 www.vareximaging.com
1.3. 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, and notes that are important for correct and safe use of the
device.
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 or can cause environmental
pollution.
NOTE:
Notes provide advice and highlight unusual points. A note is not intended as an instruction.
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 10 series.
Information regarding serious incidents that have occurred using the Optica 10 series must be reported to
Varex Imaging Nederland B.V. and the competent authority.
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 10 series in any way other than described in this manual.
•Use of the Optica 10 series other than the INTENDED USE.
•The Optica 10 series is not subjected to regular inspection and maintenance.
•Use of the Optica 10 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 10 series is 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 UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 8/28 www.vareximaging.com
1.5. General warnings, cautions and notes
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.
WARNING:
The collimator contains a Class 2 laser. Do not stare into the laser beam.
WARNING:
Be extra careful with unconscious patients because they cannot blink their eyes to protect their
eyes to the possible hazardous optical radiation (field light and laser).
WARNING:
When there is structural damage to the housing of the collimator or if the collimator is
malfunctioning, label the collimator as “out of order” and have the collimator repaired prior to
further use.
WARNING:
If the collimator is used in mobile applications, strong vibrations shall be avoided.
WARNING:
Do not modify this equipment without (written) 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:
The collimator may be configured with V-laser. The V-laser is set at a predefined SID. This SID
setting may be used as indicative value only. The actual SID can be determined with the
integrated tape measure (see §2.4)
WARNING:
The collimator shall only be used with specified conditions listed in §6
WARNING:
The temperature of the enclosure can become more then 41 °C
WARNING:
Preventive checks (see TM50736) shall be carried on a regular basis. The interval of these
checks shall be tailored to the application and frequency of use.
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:
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 [ME
EQUIPMENT or ME SYSTEM], including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
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.

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 9/28 www.vareximaging.com
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.
1.6. Labels and markings on the device
Symbol
Explanation
Manufacturer
Date of manufacture
Serial number
1639
CE-mark directive 93/42/EC; conformity assessment by notified body 1639
(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.
AC supply voltage indication (optional feature).
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.
Explanatory warning for laser radiation (optional feature)

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 10/28 www.vareximaging.com
Symbol
Explanation
Warning: Laser emission, possibly hazardous optical radiation emission Identifies
the exit point of the laser beam (optional feature)
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 single line laser or V-laser (optional feature)
Operate field light indicator
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 UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 11/28 www.vareximaging.com
1.7. 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 10 series
This Technical Manual is applicable for the below stated part number:
Optica10-VV-XXX-YYY-LLL
(where “VV” stands for the release version of the model)
(where “XXX-YYY” stands for a sequel code to define the configuration)
(where “LLL” implicates the regional version)
1
Accessory Kit
Contains:
•1 User Manual
•1 Technical Manual
•1 ECDoC
OR
•Leaflet referring to website for digital
version of Manual / ECDoC
AND
•1 Terminal adapter
50737
Content depends on the model as described above
Be advised by your distributor or Varex Imaging Nederland B.V. for any accessories available. See also §6.3.

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 12/28 www.vareximaging.com
2.Device description
This chapter will describe the device in general and detail. The device is pointed out with features present in
§2.4. Classifications of the device are listed in §2.11.
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 device
The Optica 10 series X-ray collimator. The Optica 10 series is operated manually and consists of independent
moveable shutter pairs. The shutters are limiting (collimating) the diagnostic X-ray field. The Optica 10 series
projects a light field to indicate the size and position of the diagnostic X-ray field. A measuring tape is
provided to measure the SID.
Additionally, the device can be configurated with:
- A single line laser or V-laser for alignment of the X-ray image receptor. The V-laser also
functions as a SID indication (coinciding line at fixed distance).
- A filter module to provide additional filtration.
- Means for mounting additional accessories.
For operation and usage see chapter 3 and chapter 4.

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 13/28 www.vareximaging.com
2.3. Principle of operation
The operable features to perform the INTENDED USE of the collimator are positioned on the front of the
collimator. The following table shows symbols that are used to indicate the operable features:
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)
Symbol used to indicate the laser button switch. Press
the button to activate the single line laser or V-laser.
n/a
Additional filtration (optional)
Additional filtration can be selected by rotation of the
filter module (see Figure 1)
2.4. Overview of the device
This section gives an overview of the collimator.
Figure 1: Device, Front view
Long shutters
control knob
Cross shutters
control knob
(Optional) filter
module
Light button
(Optional)
laser button
Status LED

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 14/28 www.vareximaging.com
Figure 2: Device, Bottom view
V-laser
aperture
Single laser
aperture
Single laser
aperture shutter
Accessory
retaining latch
SID tape
measure
V-laser
aperture
V-laser
aperture
shutter
Accessory
rails

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 15/28 www.vareximaging.com
Accessory rail specifications
Maximum accessories: 2
Maximum allowed total weight of accessories: 2 kg
Accessory rail interface dimensions, see also figure below
Width (d1): 176 – 177 mm
Optional Width (d1): 150 – 151 mm
Thickness (d2): Max 2.3
Pitch between slots (d3): 4.5 mm
Length (d4): max. 177 mm
Lock – collimator center distance (d5): 89 mm
Slot to collimator housing (d6): 5 mm
Figure 3: Accessory rail specification
WARNING:
Check fit and locking of (inserted) accessory. The accessory must fit and be properly mounted
to prevent it from falling.
d1
d6
d5
d4
d2
d3

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 16/28 www.vareximaging.com
2.5. Main dimensions
Figure 4: Main dimensions
2.6. Aluminum equivalent
The Aluminum equivalent (or ATTENUATION EQUIVALENT) can be found on the product label. The location
of the product label can be found in §6.2. The ATTENUATION EQUIVALENT is expressed in [mm] aluminum.
2.7. Restriction 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.
2.8. ESSENTIAL PERFORMANCE
The Optica 10 series does not have essential performance.
2.9. APPLIED PARTS
No APPLIED PARTS are identified for the Optica 10 series.
2.10. Known contraindication(s)
Contraindications of the X-ray system continue to apply (see X-ray system documentation).
Additional the Optica 10 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 10 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).

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 17/28 www.vareximaging.com
2.11. Classifications
Subject
Classification
Reference
Electrical safety
Class I
IEC 60601-1
Electromagnetic Compatibility
intended environment
Professional healthcare facility
environment
IEC 60601-1-2
Mode of operation
Continuous
IEC 60601-1
Ingress protection
IP2X
IEC 60529
Laser
Class 2
IEC 60825-1
Field light
Risk Group 2
IEC 62471
Not intended for use in Oxygen Rich environment.
Not suitable for Sterilization.
2.12. Installation
The installation instructions for the device are available in the Technical Manual (see TM50736).

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 18/28 www.vareximaging.com
3.Operating instructions
This chapter describes the operating instructions. Powering ON and OFF are described in §3.1. The status
LED colors are clarified in §3.2. A description of features to perform the INTENDED USE is given in §3.3.
3.1. Switching the device ON and OFF
The collimator does not have a switch to power on/off the device.
POWER-ON:
When the power supply to the collimator is switched ON, the collimator performs a power-ON self-test. During
the power-ON self-test (which takes a few seconds), the status LEDs are flashing orange. The initialization
cycle ends with a green status color for each status LED during 1 second. When the status LEDs are turned
off, the collimator is ready for use. If the power-ON self-test is not successful, the status LED above the light
button will be flashing red. See §3.2 for further information.
POWER-OFF:
There is no shutdown procedure for the collimator. The collimator can be switched OFF at any time without
damaging the collimator. This is done by switching OFF the power supply to the collimator.
3.2. Status LED color
On the front panel status LEDs are present above the light- and laser button, indicating the ON/OFF status of
the field light and the laser.
The status LED above the light button can show the colors green, orange and red.
The status LED above the laser button can only show the green color.
Color
Flashing
Meaning
No color
No
OFF state
Orange
Yes
Initializing
Green
No
ON state
Green
No
Just 1 second after orange flashing:
End of initializing
Green
Yes
Short flashing after Laser switch-on:
Laser does not function
Red
Yes
ERROR state

User Manual UM50735-EN
Optica 10 series
Revision: 12
Date of release: 2020-04-01 19/28 www.vareximaging.com
3.3. Device features
This section describes the features which can present on the collimator. Depending on the configuration of
the collimator some features may be unavailable. The following figures show a generic model, characteristics
like layout, color and available features can be different.
A. The collimator is equipped with two control knobs. The knobs control the shutters to define the
diagnostic area. Knob A1 controls the shutters in the cross direction. Turning knob A1 clockwise
closes the shutters in cross direction. Knob A2 controls the shutters in the long direction. Turning knob
A2 counterclockwise closes the shutters in long direction.
A1. Knob for moving shutters
in cross direction:
A2. Knob for moving shutters
in long direction:
Figure 5: Shutter control
CAUTION:
Striving the control knobs beyond the mechanical limits could result in damage to the
collimator
B. Scale indication for field size is set out. The scale indicates the (X-ray) field size at two SID distances.
An indication for SID 100[cm] (40”) and 180[cm] (72”) are available. The pointer of the shutter control
knob points out the (X-ray) field size dimension. The field size dimension is given in centimeters and
inches. The value between parentheses show the value in inches.
NOTE:
Take into account that a read inaccuracy can occur since it is an approximate and optical
read-out.
Open
Close
Open
Close
A1
A2

User Manual UM50735-EN
Optica 10 series
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C. Push button for light field indicator, a green indication LED will light above the button. The light
will be activated for a pre-defined time and will switch off automatically. Push the button again to
switch off the light field.
D. Push button for activating single line laser or V-laser for alignment purposes (optional feature).
The laser will be activated for a pre-defined time and will switch off automatically. Push the button
again to switch off the laser. A green indication LED will light above the button.
E. Additional to the single line laser of V-laser, laser shutter(s) are present. These laser shutter(s) are
added to close the laser aperture. Slider E1 shuts off or opens the laser apertures of the V-laser.
Slider E2 shuts off or opens the laser aperture of the single line laser. The sliders will snap-lock once
in the correct position.
E1. Laser shutter for V-laser
E2. Laser shutter for single line laser
Figure 6: Laser shutter(s)
F. Measuring tape for determining SID. Pull out the lever and place it against the designated surface
(e.g. table, wall stand, etc.). The SID value can be read on the measuring tape where it exits the
collimator enclosure. The maximum value to be measured is 2m / 80”.
WARNING:
Incorrect readout of the measuring tape could result in under or overexposed x-ray image
CAUTION:
Pulling out the measuring tape beyond the maximum value can cause breakage and/or
distortion of the tape. Always guide the measuring tape back to its start position.
E1
E2