Varex Imaging Optica 20 Series User manual

UM50589-EN, Revision: 4.0
www.vareximaging.com
Optica 20 series
User Manual

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 2/20 www.vareximaging.com
This page is deliberately left blank.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 3/20 www.vareximaging.com
Table of Contents
1. Introduction........................................................................................................................................5
1.1. Contact information .................................................................................................................5
1.2. Abbreviations, acronyms and definitions ................................................................................5
1.3. Symbols used in this document ..............................................................................................5
1.4. Advisory...................................................................................................................................6
1.5. Radiation danger.....................................................................................................................6
1.6. General warnings, cautions and notes....................................................................................7
1.7. Labels and markings on the device ........................................................................................8
1.8. Supplied components..............................................................................................................9
2. Device description .......................................................................................................................... 10
2.1. Intended use ........................................................................................................................ 10
2.2. Description of the device...................................................................................................... 10
2.3. Principle of operation ........................................................................................................... 10
2.4. Overview of the device......................................................................................................... 10
2.5. Accessories...........................................................................................................................11
2.6. Aluminium attenuation equivalence ......................................................................................11
2.7. Restrictions on use................................................................................................................11
2.8. Essential performance ..........................................................................................................11
2.9. Applied parts .........................................................................................................................11
2.10. Known contraindication(s).....................................................................................................11
2.11. Classifications .......................................................................................................................11
2.12. Installation .............................................................................................................................11
3. Operating instructions .................................................................................................................... 12
3.1. Switching the device ON and OFF....................................................................................... 12
3.2. Overview general Optica 20 controls ................................................................................... 12
3.3. Bucky line laser .................................................................................................................... 15
3.4. Filter module ........................................................................................................................ 15
4. Quality Assurance .......................................................................................................................... 16
5. Maintenance and cleaning ............................................................................................................. 16
5.1. Safety precautions ............................................................................................................... 16
5.2. Preventive maintenance, trouble-shooting and repair ......................................................... 16
5.3. Cleaning ............................................................................................................................... 16
5.4. Disinfection........................................................................................................................... 16
6. Disposal and EMC compatibility..................................................................................................... 16
6.1. Disposal................................................................................................................................ 16
6.2. EMC compatibility ................................................................................................................ 17
7. Technical specification.................................................................................................................... 18
7.1. Product label ........................................................................................................................ 19
Product label for DC input models ................................................................................................. 19
Product label for AC/DC input models............................................................................................ 19

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 4/20 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.
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: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 5/20 www.vareximaging.com
1.Introduction
This document is accompanying the Optica 20 series (see also §1.8). 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
Anholtseweg 44,
7091 HB Dinxperlo
The Netherlands
Telephone
+31 (0)315 659 150
Fax
+31 (0)315 659 140
E-mail
Netherlands.CNC@vareximaging.com
Website
www.vareximaging.com
1.2. Abbreviations, acronyms and definitions
Term
Definition
Collimator
Optica 20 series (X-ray Collimator)
Optica 20
Optica 20 series (X-ray Collimator)
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
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.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 6/20 www.vareximaging.com
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 20 series.
Information regarding accidents that have occurred using the Optica 20 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 20 series in any way other than described in this
manual.
•Use of the Optica 20 series other than the INTENDED USE.
•The Optica 20 series is not subjected to regular inspection and maintenance.
•Use of the Optica 20 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 20 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: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 7/20 www.vareximaging.com
1.6. 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. (Optional feature) 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 shall only be used with specified conditions listed in chapter 7.
WARNING:
The temperature of the enclosure can become more then 41 °C
WARNING:
Preventive checks (see Technical manual, TM50590) 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 Optica 20 series, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
WARNING:
To avoid the risk of electric shock, this equipment must only be connected to a medical
grade power supply.
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.
NOTE:
Due to the multiple options / configurations of the Optica 20 series, the pictures used
may not always exactly represent the type of collimator that you have.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 8/20 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.
1.7. 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)
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
(optional feature)

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 9/20 www.vareximaging.com
Symbol
Explanation
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 line laser (optional feature)
Operate field light indicator
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 §7. for storage conditions if the device is not
used directly.
The packaging contains the following components:
Amount
Description
Reference
1
Optica 20 series
Standard Model, DC input:
Standard Model, DC input, Filter module:
Standard Model, ACDC input:
Standard Model, ACDC input, Filter
module:
50250-1N-LLL (**)
50251-1N-LLL (**)
50600-1N-LLL (**)
50601-1N-LLL (**)
1
Document Kit
Contains:
•1 User Manual
•1 Technical Manual
•1 Strain relief
•1 Top shutter caliber
•1 ECDoC
50771-LLL
(**):The catalogue number contains “1N-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.
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: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 10/20 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 §7. 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 Varex Imaging Nederland B.V. Optica 20 series collimators are devices which are used to limit the
size of the direct X-ray exposure to the patient and for reducing the scattered radiation.
The Optica 20 series contains a LED for indication of the actual field to be exposed and optional has a
laser line for alignment with the Bucky. For measuring the SID, a measuring tape is integrated.
Additionally, a filter module can be integrated for extra filtering of the X-ray beam (see §1.8).
2.3. Principle of operation
The Optica 20 series is a component which is integrated in a regular X-ray system that is used for
RAD diagnostic purposes. The collimator is mounted directly onto the X-ray tube housing, against the
exit window in the direct X-ray beam.
The main purpose of the collimator is to limit the size of the direct X-ray exposure to the patient and to
reduce the scattered radiation. Limiting the size of the direct X-ray beam means that the patient is only
exposed to X-rays in the diagnostic area and thus receives a minimal radiation dose. Limiting the size
of the X-ray beam is achieved by moving X-ray blocking shutters in and out of the X-ray beam.
The dimension of the X-ray field is visualized with a corresponding light field. The result is an X-ray
image created by the Image Receptor.
2.4. Overview of the device
Optica 20 with Bucky line laser
Optica 20 with filter module and Bucky line

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 11/20 www.vareximaging.com
2.5. Accessories
As accessory, a fixed or rotating mounting flange is available for attaching the collimator onto the X-ray
tube. Details on installation and maintenance are outlined in the Technical Manual TM50590.
2.6. Aluminium attenuation equivalence
The Optica 20 series has the following aluminium attenuation equivalents:
Standard Optica 20 series configuration
1.2 mm Al @ 75kV
2.7. 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.
2.8. Essential performance
The Optica 20 series does not have essential performance.
2.9. Applied parts
The Optica 20 series does not have applied parts.
2.10.Known contraindication(s)
Contraindications of the X-ray system continue to apply (see X-ray system documentation).
Additionally, the Optica 20 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 20 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).
2.11.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
IP20
IEC 60529
Laser
Class 1 (Optional feature)
Class 2 (Optional feature)
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.
For more information, contact your distributor or Varex Imaging Nederland B.V..

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 12/20 www.vareximaging.com
3.Operating instructions
3.1. Switching the device ON and OFF
The Optica 20 series does not have a separate switch for switching on the device and is operational
when the entire X-ray system is powered on. The Optica 20 series can be powered off at any time
without causing damage to the device.
3.2. Overview general Optica 20 controls
Layout and units of the graphics is depending on the Optica 20 series model and can be different from
the pictures below.
A. Knob for moving shutters in cross
direction:
B. Knob for moving shutters in long
direction:
Turn the applicable knob in direction as illustrated above to widen or narrow the exposed area in the
long and/or cross direction.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 13/20 www.vareximaging.com
C. Scale division for indicating the field size compared to the SID.
To set the required field size, the SID is needed (one option is to use the built-in measuring tape).
Follow the applicable curve which indicates the determined SID. The desired field size is set once the
pointer (attached to the knob) intersects the SID-curve combined with the field-size curve. See
pictures above for clarification.
NOTE:
Take into account that a read inaccuracy can occur since it is an approximate and optical
read-out.
D. Push button for activating laser line for Bucky alignment (optional feature).
The laser will be activated for a pre-defined time and will switch off automatically. Push the
button for ±2 seconds to switch off the laser. A green indication LED will light inside the button.
Pay attention! In case the collimator is not equipped with a laser, this push button function is
not available.
E. Push button for light field indicator, a green indication LED will light inside the button.
The light will be activated for a pre-defined time and will switch off automatically. Push the
button for ±2 seconds to switch off the light field.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 14/20 www.vareximaging.com
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:
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, sudden release of the
measuring tape can cause damage to humans, the tape itself and/or collimator housing.
G. Accessory rails, suitable for holding maximum of two accessories with outside dimensions of
176x176mm and a maximum thickness of 2mm in the cut-out of the rail.
H. Lock spring for accessories; slightly pull out the spring and remove the applicable accessory.
CAUTION
Be careful when handling the lock spring, over-elongating the spring can cause
permanent damage to the lock spring.
H
G
1
F

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 15/20 www.vareximaging.com
3.3. Bucky line laser
The displayed line of this laser is according to the picture below. The dimension and location of the line
varies as the SID changes.
Bucky line laser dimensions at 1 meter SID
3.4. Filter module
The filter module is an optional feature for the Optica 20 series, this paragraph is only applicable in
case the collimator is equipped with the filter module option.
Front view filter disc
Top view filter disc
Turn the disc clockwise or counter clockwise to select the required additional filter material, the disc
will snap-lock once in the correct position. The filter material is written on top of the disc (for example
see also print screen above) and at the bottom of the disc, the composition of the material is
configured on request and can vary. Also, each position has an indication (from 1 up to 4 lines) at the
perimeter of the disc. Position 1 (indicated as “0” on top and bottom of the disc) is always the no-filter
position, the other three positions contain filters.
WARNING:
Choose the filter material carefully, selecting the wrong filter could result in an
unexpected image quality. Always verify the selected filter position.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 16/20 www.vareximaging.com
4.Quality Assurance
For the Optica 20 series, there are no quality assurance checks necessary or applicable.
5.Maintenance and cleaning
5.1. Safety precautions
When there is structural damage to the housing of the device, label the device as “out of order” and
have the device repaired prior to further use.
5.2. Preventive maintenance, trouble-shooting and repair
Refer service to a qualified maintenance technician only. See Technical Manual.
5.3. Cleaning
Cleaning with a damp cloth is recommended. Use neutral cleaning products and do not soak the
device with liquid.
5.4. Disinfection
Disinfection with a damp cloth with Isopropyl alcohol is recommended. Before using a disinfectant,
check at an inconspicuous spot on the device if the disinfectant will not damage the plastic and/or
coated metal surfaces.
Do not soak the device with liquid.
6.Disposal and EMC compatibility
6.1. Disposal
This device contains substances that can be hazardous to the environment and care should be taken
when disposed of.
The device is marked with the following symbol:
Follow national and local regulations regarding disposal of electronic equipment.
Packaging material shall be recycled according national and local regulations.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 17/20 www.vareximaging.com
6.2. EMC compatibility
The device conforms to IEC 60601-1-2:2014 for EMC compatibility and must be used according to the
EMC information provided in this manual.
WARNING:
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
WARNING:
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
NOTE:
The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 18/20 www.vareximaging.com
7.Technical specification
Classifications
See section 2.11
Application
Mobile and stationary equipment for radiography (see §2.1)
Materials
ABS, PC, POM, stainless steel, aluminium, lead
Power source
VDC Models
24 VDC ± 10%, 24 VA
Optional, depending on model
VDC / VAC Models
12-45 VDC ± 10% / 24 VA
20-30 VAC ± 10% / 35 VA 50/60 Hz
Application
Limiting primary X-ray beam, part of an X-ray system
Light field luminosity
≥ 160 lx
Light field / X-ray alignment
≤ 1% SID
Light field edge contrast ratio
≥4
SID tape measure range
90 – 200 [cm]
Field size
Min. 3x3cm @ 1m SID [1.2”x1.2” @ 39.4” SID]
Max. 43x43cm @ 1m SID [16.9”x16.9” @ 39.4” SID]
Weight
±8 kg
Size
(WxDxH) 230x267x177mm [9.1”x10.5”x7.0”]
Leakage
≤ 0.5 mGy/h
Filter module (added filtration)
(optional feature)
1 mm Al + 0.1 mm Cu
1 mm Al + 0.2 mm Cu
2 mm Al
None
Operation environment
Ambient temperature: 15 – 40 °C
Relative humidity: 30 – 75 %, non-condensing
Atm. Pressure: 750 – 1030 hPa
Storage
Ambient temperature: -20 – 60 °C
Relative humidity: 30 – 95 %, non-condensing
Atm. Pressure: 750 – 1030 hPa
Maximum cable length
< 30 m (applies to all cables)
Cable type(s)
Unshielded or shielded; Can-bus H/L signals preferably twisted

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 19/20 www.vareximaging.com
7.1. Product label
NOTE:
The product labels as shown are representing the layout and accompanying explanation.
The attached label on the collimator shows the specific information valid for your device.
WARNING:
If the product label is missing or not readable contact your distributor or Varex Imaging
Nederland B.V.
Product label for DC input models
Product label for AC/DC input models
Medical Device
Anholtseweg 44
7091 HB Dinxperlo
The Netherlands
www.vareximaging.com
24 VDC / 24 VA
0120 710383
OPTICA 20
XXXXX-NN-LLL
WOXXXXXX/E-XX
YYYY-MM-DD
Model:
REF
SN
Only
Min. inherent filtration
Al. Equiv.: 1.2mmAl / 75 kV
X-ray rating up to: 150 kVp IP20
(01)0XXXXXXXXXXXX(11)XXXXXX(21)WOXXXXXX/E-XX
This product complies with the requirements of21 CFR SubchapterJ for radiation emitting products in e ffecton the date ofmanufacture.
This product complies with 21 CFR 1040.10 and 1040.11 exceptfor deviations pursuant to Laser Notice No. 50, dated July 26, 2001
Medical Device
Anholtseweg 44
7091 HB Dinxperlo
The Netherlands
www.vareximaging.com
12 - 45 VDC / 24 VA
20 - 30 VAC / 35 VA, 50/60 Hz
0120 710383
OPTICA 20
XXXXX-NN-LLL
WOXXXXXX/E-XX
YYYY-MM-DD
Model:
REF
SN Min. inherent filtration
Al. Equiv.: 1.2mm Al / 75 kV
X-ray rating up to: 150 kVp IP20
(01)0XXXXXXXXXXXX(11)XXXXXX(21)WOXXXXXX/E-XX
This product complies with the requirements of 21 CFR Subchapter J for radiation emitting products in effect on the date of manufacture.
This product complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50,dated July 26, 2001
Only

User Manual: UM50589-EN
Optica 20 series
Revision: 4.0
Date of release: 2019-01-23 20/20 www.vareximaging.com
Contact details
Varex Imaging Technology (Beijing) Co., Ltd.
China
t +86 10 6780 2708
t +86 10 6780 2129
f +86 10 6780 2170
Varex Imaging Philippines Inc.
Philippines
t +63 49 5024 520
t +63 49 5024 521
f +63 49 5024 500
f +63 2 8076 472
© 2018 by Varex Imaging Nederland B.V.
All Rights reserved. No part of this document may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission
of Varex Imaging Nederland B.V..
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