Download as pdf or txt
Download as pdf or txt
You are on page 1of 40

Optica 20 series

Technical Manual

TM50590, Revision: 5.0 www.vareximaging.com


This page is deliberately left blank.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 2/40 www.vareximaging.com
Table of Contents
1. Introduction ........................................................................................................................................6
1.1. Contact information .................................................................................................................6
1.2. Abbreviations ..........................................................................................................................7
1.3. Symbols used in this document ..............................................................................................8
1.4. Advisory...................................................................................................................................8
Radiation danger .............................................................................................................................. 8
1.5. General warnings, cautions and notes ....................................................................................9
Requirements for SERVICE PERSONNEL .................................................................................... 10
1.6. Symbols on the device .......................................................................................................... 11
1.7. Supplied components ........................................................................................................... 12

2. Product description ......................................................................................................................... 13


2.1. Intended use ........................................................................................................................ 13
2.2. Description of the device ...................................................................................................... 13
2.3. Overview of the device ......................................................................................................... 14
2.4. Main dimensions .................................................................................................................. 15
2.5. Aluminium equivalence ........................................................................................................ 15
2.6. Restriction on use ................................................................................................................ 15
2.7. ESSENTIAL PERFORMANCE ............................................................................................ 15
2.8. APPLIED PARTS ................................................................................................................. 15
2.9. Known contraindication(s) .................................................................................................... 16
2.10. Classifications ...................................................................................................................... 16

3. Operating instructions .................................................................................................................... 17


3.1. Powering ON and OFF ......................................................................................................... 17
3.2. Functions during Operating Mode ........................................................................................ 17

4. Installation ...................................................................................................................................... 18
4.1. Requirements for service personnel .................................................................................... 18
4.2. Installation requirements ...................................................................................................... 18
4.3. Necessary recurrent testing ................................................................................................. 18
4.4. Installation preparations ....................................................................................................... 18
4.5. Mounting instructions ........................................................................................................... 19
4.6. Internal fixation and packaging ............................................................................................ 20
4.7. Electrical interface ................................................................................................................ 21
4.8. Alignment ............................................................................................................................. 24
4.9. Adjustments ......................................................................................................................... 24
4.10. DAP meter ............................................................................................................................ 25
4.11. Verification checks ............................................................................................................... 27

5. Mains isolation ................................................................................................................................ 28

6. Service, maintenance and cleaning ............................................................................................... 28


6.1. Preventive checks ................................................................................................................ 28
6.2. Maintenance interval ............................................................................................................ 28
6.3. Maintenance checks ............................................................................................................ 29
6.4. Troubleshooting, fault diagnosis .......................................................................................... 30
6.5. Electrical system .................................................................................................................. 30
6.6. Fuses.................................................................................................................................... 30
6.7. Accessories .......................................................................................................................... 31
6.8. Cleaning ............................................................................................................................... 32
Cleaning procedures and agents ................................................................................................... 32
Cleaning recommendations ........................................................................................................... 32
6.9. Removal from host system................................................................................................... 32
Technical Manual TM50590
Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 3/40 www.vareximaging.com
7. Options ........................................................................................................................................... 33

8. Disposal, ESD and EMC compatibility ........................................................................................... 33


8.1. Disposal................................................................................................................................ 33
8.2. ESD ...................................................................................................................................... 33
8.3. EMC compatibility ................................................................................................................ 34
Deviations ....................................................................................................................................... 34
Allowances ..................................................................................................................................... 34
Precautions .................................................................................................................................... 34
Emissions Compliance ................................................................................................................... 34
Immunity Compliance ..................................................................................................................... 35

9. Specification ................................................................................................................................... 37
9.1. Technical specifications ........................................................................................................ 37
9.2. Product label ........................................................................................................................ 38
Product label for DC input models ................................................................................................. 38
Product label for AC/DC input models ............................................................................................ 38

Figure 1: External dimensions ............................................................................................................... 15


Figure 2: Optica 20 with red protective cap ........................................................................................... 18
Figure 3: Caliber in long direction .......................................................................................................... 19
Figure 4: Caliber in cross direction ........................................................................................................ 19
Figure 5: Flange lock ............................................................................................................................. 20
Figure 6: Housing .................................................................................................................................. 20
Figure 7: Connection ground wire housing ............................................................................................ 20
Figure 8 Removing protective foam and tie-wraps ................................................................................ 21
Figure 9: Connections (power, earth, external) ..................................................................................... 21
Figure 10: Schematic overview external light field control .................................................................... 22
Figure 11: Power & External connections, DC Models ......................................................................... 22
Figure 12: Power & External connections, AC/DC Models ................................................................... 23
Figure 13: Cable exit ............................................................................................................................. 24
Figure 14: Timers adjustment ................................................................................................................ 24
Figure 15: DAP meter installation .......................................................................................................... 26
Figure 16: Assembled Lead Bracket (DAP meter not shown) ............................................................... 26
Figure 17: Location of the replaceable fuse. ......................................................................................... 31

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 4/40 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.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 5/40 www.vareximaging.com
1. Introduction
1.1. Contact information
This manual provides all the technical information necessary for the correct installation, application
and maintenance 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.
Anholtseweg 44,
Address 7091 HB Dinxperlo
The Netherlands
Telephone +31 (0)315 659150
Fax +31 (0)315 659140
E-mail Netherlands.CNC@vareximaging.com
Website www.vareximaging.com

For support and service purposes, please note the following information:

Model name: Optica 20

Part number:

Serial number: WO__________________

Part number and serial number can be found on the product label (see §9.2)

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 6/40 www.vareximaging.com
1.2. Abbreviations
Term Definition
DAP Dose area product
EMC Electromagnetic compatibility
ESD Electro Static Discharge
ME Medical Equipment
Optica 20 Optica 20 series (X-ray Collimator)
PCA Printed Circuit board Assembly
SID Source Image Distance

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 TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 7/40 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 and 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 § 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 20 series.

Host system marking and/or certification (e.g. CE-marking, NRTL certification, etc.) can be affected by
installation of the Optica 20 series. Please consult the manufacturer of the host system for advice on
installation 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.
• Installation of the Optica 20 series which is not in accordance with the installation instructions
as provided.
• Use of the Optica 20 series other than the INTENDED USE.
• Installation of the Optica 20 series by SERVICE PERSONNEL that is not qualified.
• 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.

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 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 TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 8/40 www.vareximaging.com
1.5. General warnings, cautions and notes
WARNING:
To avoid the risk of electric shock, this equipment must only be connected to a medical
grade power supply. See also chapter 5.
WARNING:
Always connect the device to protective earth, using the dedicated terminal inside the
enclosure.
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.
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 the exterior part(s) of the collimator are removed, exposure to possible injury is
present.
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 vibration 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 §2.1

WARNING:
The temperature of the enclosure can become more then 41 °C

WARNING:
Preventive checks (see §6) 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.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 9/40 www.vareximaging.com
WARNING:
Ensure that the device is powered OFF before opening collimator and/or removing the
cover(s).
WARNING:
Handle the device with care to prevent damage.

CAUTION:
For transportation, always use the dedicated Varex Imaging Nederland B.V. packaging to
avoid damage to the device.
NOTE:
Due to the different collimator configurations, the pictures used may not always exactly
represent the type of collimator that you have.

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 TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 10/40 www.vareximaging.com
1.6. Symbols on the device
Symbol Explanation

Manufacturer

Date of manufacture

Catalogue number
Serial number

CE-mark directive 93/42/EC; conformity assessment by notified body 0120


0120 (optional feature)

SGS recognized component for US & Canada, registration number 710383


(optional feature)
710383

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)

Follow the instructions for use


Reading the instructions for use is crucial for a correct and safe use of the
collimator

Identification of compliance with the provisions for EU WEEE directive

DC supply voltage indication.

AC supply voltage indication (optional feature).

Warning: Laser emission, possibly hazardous optical radiation emission


(optional feature)

OVERTURE
LASER
Warning: Laser emission, possibly hazardous optical radiation emission
APERTURE Identifies the exit point of the laser beam (optional feature)

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. Explanatory warning for hazardous optical radiation
CAUTION. Possibly hazardous optical radiation
emitted from this product.
Do not stare at operation lamp.
May be harmful to the eyes.

Explanatory warning for laser radiation (optional feature)

Indication cross shutters open

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 11/40 www.vareximaging.com
Symbol Explanation

Indication cross shutters closed

Indication long shutters open

Indication long shutters closed

Operate laser line (optional feature)

Operate field light indicator

Indication for measuring tape position

1.7. Supplied components


The device that you have purchased is packed in a transport box 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.
Store the device in a cool dry environment until ready to install.

The packaging contains the following components:


Amount Description Reference

1 Optica 20 series Standard Model, DC input: 50250-1N-LLL (*)


Standard Model, DC input, Filter module: 50251-1N-LLL (*)
Standard Model, AC/DC input: 50600-1N-LLL (*)
Standard Model, AC/DC input, Filter 50601-1N-LLL (*)
module:
1 Document Kit Contains: 50771-LLL
• 1 User Manual
• 1 Technical Manual
• 1 Strain relief
• 1 Top shutter caliber
• 1 ECDoC
(*) 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.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 12/40 www.vareximaging.com
2. Product 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 §9.1. 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 light source that shows the region which will be exposed and optional
has a laser line for alignment with the Bucky. For measuring the SID, a measuring tape is provided.
Additional, a filter module can be provided for extra filtering of the X-ray beam.

For the following device information, please refer to the User Manual:
• Intended use and patient population
• Intended users
• Principle of operation

The device provides 2 MOPP of insulation between the electronics and the outside of the housing.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 13/40 www.vareximaging.com
2.3. Overview of the device
Below an overview of the device:
Regular view: Bottom view:

B
E
D

A C

A Operating panel (front side)


B Mounting surface, including top shutters
C Filter module (optional feature)
D Accessory rails
E Exit window light – X-ray field
The accessory rails accept common accessories with a dimension of 177x177mm and a maximum
thickness of 2.2mm.
The Optica 20 also functions without accessories.

NOTE:
The operating panel may contain customized features (e.g. color, print layout, …)

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 14/40 www.vareximaging.com
2.4. Main dimensions

Figure 1: External dimensions

NOTE:
The dimensions for the top shutters are valid with shutters set at maximum opening.

2.5. Aluminium equivalence


With standard configuration, The Optica 20 series has the following aluminium attenuation equivalent:
Optica 20 1.2mm Al @ 75kV

2.6. 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.

2.7. ESSENTIAL PERFORMANCE


The Optica 20 series does not have essential performance.

2.8. APPLIED PARTS


No APPLIED PARTS are identified for the Optica 20 series.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 15/40 www.vareximaging.com
2.9. 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).

2.10. Classifications
Subject Classification Reference

Electrical safety Class I IEC 60601-1


Electromagnetic Compatibility Professional healthcare facility IEC 60601-1-2:2014
intended environment environment
Mode of operation Continuous IEC 60601-1
Ingress protection IP2X IEC 60529
Laser Class 1 (optional feature) IEC 60825-1
Class 2 (optional feature)
Field light Risk Group 2 IEC 62471
Not intended for use in Oxygen Rich environment.
Not suitable for Sterilization.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 16/40 www.vareximaging.com
3. Operating instructions
3.1. Powering ON and OFF
The Optica 20 does not have a switch to power on/off the device and is operational when the X-ray
system is powered on. The Optica 20 can be powered off at any time.

3.2. Functions during Operating Mode


Details on functions during OPERATING MODE can be found in the User Manual.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 17/40 www.vareximaging.com
4. Installation
4.1. Requirements for service personnel
The Optica 20 may only be installed, repaired and / or serviced by qualified personnel, i.e.:
• Authorized by the owner or manager of the device;
• Authorized by the manufacturer / local dealer;
• In possession of the diploma’s / certificates required by local legislation.

4.2. Installation requirements


The Optica 20 can be installed using regular tooling.

4.3. Necessary recurrent testing


There are no recurrent tests necessary for the Optica 20.

4.4. Installation preparations


Required tooling
Tool Description Remarks
A Hexagonal socket key size 2 Housing
B Phillips screwdriver size 2 Power connections
C Hexagonal socket key size 3 Flange locks
D Wrench size 7 Protective earth
E Hexagonal socket key size 2.5 Transparent window

Retract flange lock


(3x) with hex socket
screw

Figure 2: Optica 20 with red protective cap


NOTE:
Make sure the internal packaging stays in place before
proceeding with the installation preparations.

1. Release the three brass flange locks by unscrewing the hex socket screws (Tool C).
2. Remove the red protective cap.
3. Make sure the flange locks are in their start position (retracted as far as possible) before
proceeding with installing the device onto the X-ray system.
4. Together with the X-ray tube specifications calculate which mounting spacers, see § 6.7, to
use on top of the X-ray tube exit window face before installing the flange.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 18/40 www.vareximaging.com
4.5. Mounting instructions
WARNING:
Carefully follow the mounting instructions below to ensure a proper installation of the
device. Incorrect assembling can result in a dangerous situation; it could cause the
collimator to release from the X-ray system or to function incorrect.

NOTE:
Prior to installation of the collimator, the X-ray tube and Imaging modality must be placed
parallel to each other. Consult the accompanying documents of the X-ray system for
procedure.
NOTE:
An unpacked and unmounted collimator is sensitive to damage to the top shutters when
the red protective cap is removed.
If damage is suspected please use the alignment check tool to check if the position is
correct.

Installation can be done by single person. An effective way to install the collimator onto the X-ray tube
is when the X-ray tube exit window is facing upwards.
• Start to check the position of the top shutters as follows:
o Close the shutters of the Collimator
o Position the supplied caliber (PN50383) in long direction according Figure 3.
o Visually check if the long top shutters are centered and not touching the caliber notch.
o Position the caliber in cross direction according Figure 4
o Visually check if the long top shutters are centered and not touching the caliber notch.
Contact your distributor or Varex Imaging Nederland B.V. in case of a wrong top shutter
position.

Figure 3: Caliber in long direction

Figure 4: Caliber in cross direction

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 19/40 www.vareximaging.com
• Carefully place the collimator with the top shutters down and centered over the flange. Make
sure the top shutters do not hit the mounting flange and/or X-ray tube.
• When using the fixed flange align the front side of the collimator with the front face of the X-ray
tube to have a proper longitudinal alignment. Extend the flange locks (Figure 5) with the
hexagon screws until the collimator is secured but not tightened. Check if the distance between
the collimator housing and the mounting flange is equal in all directions.

Figure 5: Flange lock


• When using the rotating flange (see its instructions for proper installations) and lock the collimator
tightly in place with the three hexagon screws (use Tool C).

4.6. Internal fixation and packaging


To get the collimator ready for use, the internal fixation and packaging must be removed:
1. Remove the cover of the collimator with 6x screw, marked A on the metal housing as indicated
in Figure 6. Use tool A. DO NOT forget to disconnect the ground cable (see Figure 7).

Disconnect
Faston-
connector

Figure 7: Connection ground wire housing

Figure 6: Housing

2. Remove the protective foam, cut and remove the 3 red tie-wraps, see Figure 8.
3. Proceed to §4.7 for the electrical interface.

CAUTION:
For transportation, it is highly recommended to fix the internal construction identical as
original packed.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 20/40 www.vareximaging.com
Figure 8 Removing protective foam and tie-wraps

4.7. Electrical interface


The Optica 20 models are available with a DC power input or an AC/DC power input. See also § 9.1for
all technical specifications.

The electrical interface is established with a connection block positioned at the right-hand back side. It
is advised to use crimp terminal suitable for M3.5 screw for connecting the cable wires the connection
block.
Depending on the applied cable length an appropriate wire core diameter must be used. The supplied
strain relief shall be used to secure the cable. The strain relief is suitable for wire diameter Ø6.2 up to
Ø7.4mm (1/4 up to 9/32“).

Protective earth and external light field control


Connect the protective earth (Green / Yellow) coloured cable with adequate current capabilities to the
protective earth connection point. This point is labelled with located close to the power
connections, see Figure 9. Use a ring type terminal suitable for M4 for connection. Tool D can be used
for securing the terminal between the serrated washers.

Figure 9: Connections (power, earth, external)

For external control to switch the indicator (light) field, the following options are available:
• TL + COM connection to have the same functionality as the push button at the front cover.
• DL + COM connection to have direct control over the indicator field.
Connections must be made according the connection tables, see paragraph DC power input and
AC/DC power input.

A schematic overview external light field control can be found in table Figure 10.
Technical Manual TM50590
Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 21/40 www.vareximaging.com
CAUTION:
The (light) field indication is not intended for continuous use. Continuous use may
damage the field light LED.

Figure 10: Schematic overview external light field control

WARNING:
For continued protection against Risk Of Fire, check the product label before proceeding.
The information on the applicable power input ratings can be found on the product label,
see §9.2 Product label.

Power input
This section is applicable for Optica 20 models with a DC only power input, see Figure 11. The
electrical connections shall be made according the table below.

Figure 11: Power & External connections, DC Models

Pin Description Connections


- Ground (return)
24 VDC
+ + Power supply
TL Timer light control
COM Common (return) See Figure 11
DL Direct light control

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 22/40 www.vareximaging.com
This section is applicable for Optica 20 models with an AC/DC power input, see Figure 12

Figure 12: Power & External connections, AC/DC Models

The electrical connections shall be made according the table below.

Pin Description Connections


- Ground (return)
+ LOW + Power supply VIN 12 - 20 VDC 24 VAC
+ HIGH + Power supply 20 - 45 VDC 20 – 30 VAC
TL Timer light control
COM Common (return) See Figure 12
DL Direct light control

WARNING:
Check if the input voltage corresponds with the connected terminals.

WARNING:
Risk of Fire, do not connect + LOW and + HIGH simultaneously.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 23/40 www.vareximaging.com
Cable exit and securing
Route the cable through the strain relief and secure the cable properly (see Figure 13) without
interfering with parts inside the collimator.

Figure 13: Cable exit


The collimator is now ready to align with the centre of the X-ray beam (focal spot).
NOTE:
In case a rotating flange is used, proceed with §4.9

4.8. Alignment
To align the collimator to the X-ray beam it is necessary to do the following: Check that the collimator
is placed exactly centered to the focal spot of the tube. This can be done by placing a small tube about
20 mm long and 8 mm in diameter in the center of the imaging area. This area must be positioned
perpendicular to the X-ray beam. When the image shows a perfect circle, the focal spot is exactly
centered. At this stage, the visible cross from the transparent window is irrelevant. Once centered
secure the collimator in place by tightening the flange locks.
If the X-ray field displayed shows decrease in pixel value that might be due to shadows from the top
shutter(s). in this case unmount the collimator and use the caliber for Longitudinal and Cross top
shutters to check for correct position (see §4.5).

4.9. Adjustments
The light field and the X-ray field are factory calibrated to coincide. The dimension of the light and X-
ray field must match in both size and symmetry. The following actions will assist you in check and
adjustment:
• Set the light field to about 30x30 cm. at 1 meter SID and mark location the four corners with
radiopaque markers.
• Make an exposure with a technique adequate to display the markers.
• Measure the dimension of all markers relevant to the center of the detector and check that all is
within 2% of the light field dimensions (IEC 60601-2-54 § 203.8.102.6). (Sharp visualization of
the markers eases this procedure).
• If the deviation of the x-ray and light field is above 2%, see §4.4 step 4.

Figure 14: Timers adjustment

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 24/40 www.vareximaging.com
• The timer for the light field and the Bucky line can be adjusted by two potentiometers located on
the PCB at the back of front housing (see Figure 14). The potentiometers  are located left
and right of the Laser insert (faced from the X-ray exit side). To adjust the timer of the light field,
use the left one and the right one for the Bucky line laser. Clockwise increases the time and
counter clockwise decreases the time.
• If all is correct, mount the cover of the collimator and (when required) center the cross of the
transparent crosshair window by releasing 8 bolts located in the accessories rails (see Figure 6,
7xE + 1xA). Position the window correctly and tighten the screws again. If a DAP meter is
installed (see §0) check that the cable routing does not interfere with the inner structure. All
work is done and the collimator is now ready for use.

WARNING:
Check if the Ground wire is connected properly, see Figure 7

WARNING:
Check if the cover is in place and properly secured by the screws.

The laser line (indicating the center of the X-ray/light field) is factory calibrated. If the laser line needs
adjustment, ensure that the distance between the laser module and the collimator (metal) structural
frame is at least 3 [mm] to ensure proper clamping of the laser module in the holder.

min. 3

Figure 15: Gap between laser module and collimator (metal) structural frame

4.10. DAP meter


If a DAP meter is placed this must be done before remounting the cover. Follow the next steps to
mount a DAP meter, see Figure 16:
1. Disassemble the four screws and four washers indicated by “F”
2. Disassemble the Lead Bracket
3. Release the rear two screws “G” and remove the front two screws “G”.
NOTE:
The Collimator is prepared for mounting a DAP meter with a size of 177x177mm.
4. Position the DAP meter (including accessory rail flanges) on the Fixation Rails. Position the
DAP cable at the rear right.
5. Remount the two front screws and tighten all (4x) screws “G” to fix the DAP in place. To
properly fixate the DAP meter, washers or equivalent filling materials can be used (depending
on model and type).
6. Guide the DAP meter cable with a 7mm grommet in location Y through the cover.
7. Secure the DAP meter cable by using cable ties which can be mounted to the M3 threaded
standoffs, indicated by “X".
8. Replace the Lead Bracket, pay attention to the correct position of the bracket, see Figure 17
9. Remount the four screws and four washers indicated by “F”

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 25/40 www.vareximaging.com
WARNING:
Check if the Lead bracket is in place and properly secured with screws and serrated
washers, indicated by “F”, see also Figure 17.
10. Remount the cover according to the instructions § 4.9.

Figure 16: DAP meter installation

Figure 17: Assembled Lead Bracket (DAP meter not shown)

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 26/40 www.vareximaging.com
4.11. Verification checks
Before using the collimator, run a series of validation checks:
1. Check main functions:
a. Shutter movement
b. Shutter knob indication
c. Light (button) (including indication light)
d. Tape measure indication
e. Accessory lock
f. Presence of (warning) labels
2. Check if applicable:
a. Laser (button) (including indication light)
b. Filter module
3. Check if the alignment of the collimator with the X-ray beam center is still at an acceptable
level. Follow the instructions of §4.8 if the alignment is not correct.
4. Switch on light indication field, mark the outline of the light field.
5. Take a reference X-ray image.
6. Check and compare if the reference image coincides with the expected result (e.g. initial
reference image) and if the light field still matches the X-ray beam.

After successful result of the verification checks mentioned above the collimator is ready for use.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 27/40 www.vareximaging.com
5. Mains isolation
The Optica 20 series shall only be connected to secondary circuit voltages (See §9.1for the max.
electrical ratings) of an IEC 60601-1 compliant ME system which are separated from the mains supply
by 2 Means Of Patient Protection (2MOPP). A connection to supply mains is not applicable for the
Optica 20 series.

6. Service, maintenance and cleaning


WARNING:
Service may only be executed by qualified service personnel.
Ensure that the device is powered off before removing the cover to check the inside of
the collimator.
CAUTION:
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.

6.1. Preventive checks


It is recommended to perform preventive checks on a regular basis. The interval of these checks shall
be tailored to the application and frequency of use.

Action Checkpoints
Visual inspection on all outer parts No damage of parts
Check electronic functionality 1. Ensure that light field and laser (if
applicable) switches on for the set time once
the button is pressed.
2. Verify if light and laser (if applicable)
switches off once the button is pressed.
Check shutter movements Verify if the cross and long shutter are moving
smoothly
Check filter movement (if applicable) Verify if the filter is running smoothly and the
detention is working properly.
Check lock wedges All wedges are properly fixed, see §4.5
Accessory rails 1. Check on excessive wear
2. Check functionality locking lever
Mirror & transparent window Visually check on wear caused by X-ray beam.

6.2. Maintenance interval


The device requires general maintenance and/or checks every 6 months. The interval of the
maintenance shall be tailored to the application and frequency of use.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 28/40 www.vareximaging.com
6.3. Maintenance checks
Action Checkpoints
Visual inspection on all outer parts - No damage
- Clean
- Fixed in place
Visual inspection of all electronic parts - No damage
- Clean
- Fixed in place
Check on all mounting points - No damage
- Fixed in place
- Fasteners still tightened
Check electronic functionality - Ensure that light field and laser (if
applicable) switches on for the set time
once the button is pressed.
- Verify if light and laser (if applicable)
switches off once the button is pressed
for ±2 seconds.
Check drive components for shutter movements - For all parts: no excessive wear, smooth
operation
- If required, lubricate linear guiding by
applying thin layer of oil onto rail. Use
mineral oil base with thickeners acc. to
DIN51825 (K1K, K2K).
- If required, lubricate bevel gear toothed
wheels with Sumitec 219 or equivalent.
- Check tension of toothed belts
Check filter movement (if applicable) - Verify if the filter is running smoothly and
the detent is working properly. No
excessive wear of parts.
Accessory rails - Check on excessive wear
- Clean
- Fixed in place
- Check functionality locking lever
Mirror & transparent window - Check on wear caused by X-ray beam,
verify if luminosity and/or contrast value
of light beam is within expected values
Check on light field X-ray alignment - See § 4.8 and 4.9

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 29/40 www.vareximaging.com
6.4. Troubleshooting, fault diagnosis
Problem Explanation and instruction

Explanation
1. Collimator power Supply is cut-off. (No power supply)
Or
2. Field light (Power LED) defective

Instructions
No light field
1. Check if green indication LED (see User Manual) lights up after
or laser (optional) operating push button
If problem persist:
2. Check if the Collimator is connected correctly to the power supply, see
§ 4.7
3. Check if fuse (F2) needs to be replaced, see § 6.6
4. If problem persists, contact your distributor or Varex Imaging
Nederland B.V..

Explanation:
Focal distance not correct.
Instructions:
Check mounting flange distance. Remove spacer(s) to adjust the
X-ray field smaller than mounting plane distance.
light field
Explanation:
Possible collision of top shutters with X-ray tube port.
Instructions:
1. Check the top shutter arrangement (see §4.5).

Explanation:
Focal distance not correct.
X-ray field larger than
light field Instructions:
Check mounting flange distance. Add spacer(s) to adjust the mounting
plane distance.

6.5. Electrical system


On request, more detailed information is available for servicing the device. Contact your distributor or
Varex Imaging Nederland B.V..

6.6. Fuses
The Optica 20 AC/DC Models are equipped with a replaceable fuse (F2). The fuse is located next to
the terminal block, see Figure 18.
A spare/replacement fuse can be obtained at Varex Imaging Nederland B.V. as accessory part. See
for part number and rating, § 6.7
WARNING:
For continued protection against risk of fire, replace only with a fuse of the same type
and having the same electrical rating

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 30/40 www.vareximaging.com
Figure 18: Location of the replaceable fuse.

6.7. Accessories
The Optica 20 is supplied without any accessories. The following accessories are available:
Description Reference Remarks
Mounting flange fixed (height 25mm) PN 50385 Longitudinal and lateral float 2 mm.
Rotating mounting flange (height 18mm) PN 50174
Mounting spacer 1.0mm PN 50130
Mounting spacer 1.5mm PN 50131
Fuse (F2) PN 50599 Rating: Littelfuse TE5 series Type
Location see § 6.6 396, 2.0A 125V.
Manufacturer Part number:
39612000440

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 31/40 www.vareximaging.com
6.8. Cleaning
Cleaning procedures and agents
Follow local, national and organizational procedures regarding cleaning. The following agents are safe
to use:
Agents

Isopropanol
Ethyl alcohol
The cleaning agents above may be diluted with water for cleaning purposes.

WARNING:
Use of cleaning agents other than described to be save may result in damaging the
collimator or possible injury to the user.

Cleaning recommendations
- Make sure the collimator is switched OFF (see §3.1 for instructions)

WARNING:
Use of abrasive cleaning could result in deterioration of the collimator. E.g. the crosshair
window can be damaged which will result in reduction of light field illumination.

- Do not use abrasive cleaning products.

WARNING:
Do not spray, pour or soak the collimator with liquids.

- Use a damp soft cloth to clean the collimator, this will reduce the possibility for liquids
to enter the collimator. Use a dry soft cloth to remove any residuals from the collimator.

6.9. Removal from host system


If the collimator needs to be removed from the host system, follow the directions from §4 in reverse
order.

WARNING:
When the flange locks are untightened make sure the collimator is supported.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 32/40 www.vareximaging.com
7. Options
Contact Varex Imaging Nederland B.V. for available options, e.g. customer-specific colour, front
sticker, etc.

8. Disposal, ESD and EMC compatibility


8.1. 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.

8.2. ESD
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 TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 33/40 www.vareximaging.com
8.3. EMC compatibility
The device conforms to IEC 60601-1-2:2014 for EMC compatibility and must be installed and put into
service according to the EMC information provided in this manual.
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, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
WARNING:
Not taking EMC measures into account on the wiring may result in increased EMISSIONS
or decreased IMMUNITY. IEC 60601-1-2:2014 must be followed for being complaint with
EMC guidelines.
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.

Deviations
No deviations from IEC 60601-1-2:2014 are applied.

Allowances
No allowances from IEC 60601-1-2:2014 are used.

Precautions
Precautions to be taken to prevent adverse events to the PATIENT and the OPERATOR due to
Electromagnetic Disturbances are listed in the column “Electromagnetic environment – guidance” in
the tables below.

Emissions Compliance
Guidance and manufacturer’s declaration – electromagnetic emissions
The Optica 20 is intended for use in the electromagnetic environment specified below. The customer or user of the Optica 20
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions group Group 1 The Optica 20 uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions class Class A The EMISSIONS characteristics of Optical 10 make it suitable for
CISPR 11 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
Harmonic emissions Not Applicable normally required) this equipment might not offer adequate
IEC 61000-3-2 protection to radio-frequency communication services. The user
Voltage fluctuations/ Not Applicable might need to take mitigation measures, such as relocating or re-
flicker emissions orienting the equipment.”
IEC 61000-3-3

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 34/40 www.vareximaging.com
Immunity Compliance
Guidance and manufacturer’s declaration – electromagnetic immunity – ENCLOSURE PORT
The Optica 20 is intended for use in the electromagnetic environment specified below. The customer or user of the Optica 20
should assure that it is used in such an environment.
Immunity test Compliance Test level Electromagnetic environment - guidance
Electrostatic ± 8 kV contact Floors should be wood, concrete or ceramic tile. If floors are
discharge (ESD) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV covered with synthetic material, the relative humidity should be
IEC 61000-4-2 air at least 30 %.

Proximity fields from See next table below Portable RF communications equipment (including peripherals
RF wireless such as antenna cables and external antennas) should be used
communications no closer than 30 cm (12 inches)
equipment
IEC 61000-4-3
Power frequency 30 A/m Power frequency magnetic fields should be at levels
(50/60 Hz) magnetic characteristic of a typical location in a typical commercial or
field hospital environment.
IEC 61000-4-8

Guidance and manufacturer’s declaration – electromagnetic immunity –


Compliance Test Levels for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test Maximum IMMUNITY
Band Servicea) Modulation Distance
frequency power TEST LEVEL
(MHz) (MHz) (W) (m) (V/m)
Pulse modulation b)
385 380 – 390 TETRA 400 1,8 0,3 27
18 Hz
FM
GMRS 460; ± 5 kHz deviation
450 430 – 470 2 0,3 28
FRS 460
1 kHz sine
710
LTE Band 13, Pulse Modulation b)
745 704 – 787 0,2 0,3 9
17
780 217 Hz
810 GMS 800/900;
TETRA 800; Pulse Modulation b)
870 800 – 960 iDEN 820; 2 0,3 28
CDMA 850;
930 LTE Band 5 18 Hz
1 720 GSM 1800;
CDMA 1900; Pulse Modulation b)
1 845 GSM 1900;
1 700 – 1 990 2 0,3 28
DECT;
1 970 LTE Band 1, 3, 217 Hz
4, 25; UMTS
Bluetooth;
WLAN Pulse Modulation b)
2 450 2 400 – 2 570 802.11 b/g/n; 2 0,3 28
RFID 2450;
217 Hz
LTE Band 7
5 240
Pulse Modulation b)
WLAN 802.11
5 500 5 100 – 5 800 0,2 0,3 9
a/n
217 Hz
5 785
a)
For some services, only the uplink frequencies are included.
b)
The carrier is modulated using a 50 % duty cycle square wave signal.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 35/40 www.vareximaging.com
Guidance and manufacturer’s declaration – electromagnetic immunity – Power and Signal PORTs
The Optica 20 is intended for use in the electromagnetic environment specified below. The customer or user of the Optica 20
should assure that it is used in such an environment.
Immunity test Compliance Test level Electromagnetic environment - guidance
Electrostatic ± 8 kV contact Floors should be wood, concrete or ceramic tile. If floors are
discharge (ESD) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV covered with synthetic material, the relative humidity should be at
IEC 61000-4-2 air least 30 %.

Electrical fast ± 2 kV AC and DC power ports Mains power quality should be that of a typical commercial or
transient/burst ± 1 kV signal ports hospital environment.
IEC 61000-4-4
100kHz repetition frequency
Surges Not Applicable The Optica 20 is intended to be supplied by a secondary IEC
Line-to-line 60601-1 compliant AC or DC power supply.
IEC 61000-4-5
Surges Not Applicable
Line-to-ground
IEC 61000-4-5
Conducted 3 V a) Field strengths from fixed RF transmitters, as determined by an
disturbances induced 0,15 MHz – 80 Mhz electromagnetic site survey c), should be less than the
by RF fields compliance level in each frequency range.
IEC 61000-4-6 Interference may occur near equipment marked with the
6 V a) in ISM bands between following symbol:
0,15 MHz and 80 MHz b)

80 % AM at 1 kHz

Voltage dips Not Applicable The Optica 20 is intended to be supplied by a secondary IEC
IEC 61000-4-11 60601-1 compliant AC or DC power supply.

Voltage interruptions Not Applicable


IEC 61000-4-11
a)
r.m.s. before modulation is applied
b)
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553
MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15
MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to
10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to
29,7 MHz and 50,0 MHz to 54,0 MHz.
c)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Optica 20 is used exceeds the applicable RF
compliance level above, the Optica 20 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Optica 20.
NOTE
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 36/40 www.vareximaging.com
9. Specification
This chapter gives specifications (technical and product label information).

9.1. Technical specifications


Materials ABS, PC, POM, stainless steel, aluminum, lead
Classifications See §2.10
Application Mobile and stationary equipment for radiography (see §2.1)
Power source VDC Models 24 VDC ± 10%, 24 VA
12-45 VDC ± 10% / 24 VA
Optional, depending on model VDC / VAC Models
20-30 VAC ± 10% / 35 VA 50/60 Hz
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]
Min. 3x3cm @ 1m SID [1.2”x1.2” @ 39.4” SID]
Field size
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
1 mm Al + 0.1 mm Cu
Filter module (added filtration) 1 mm Al + 0.2 mm Cu
(optional feature) 2 mm Al
None
Ambient temperature: 15 – 40 °C
Operation environment Relative humidity: 30 – 75 %, non-condensing
Atm. Pressure: 750 – 1030 hPa
Ambient temperature: -20 – 60 °C
Storage 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

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 37/40 www.vareximaging.com
9.2. 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.

Product label for DC input models

Anholtseweg 44
7091 HB Dinxperlo
The Netherlands 0120 Only
www.vareximaging.com 710383

Model:OPTICA 20 Medical Device


REF XXXXX-NN-LLL
24 VDC / 24 VA
SN WOXXXXXX/E-XX Min. inherent filtration
YYYY-MM-DD 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 e ffect 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

Product label for AC/DC input models

Anholtseweg 44
7091 HB Dinxperlo
The Netherlands 0120 Only
www.vareximaging.com 710383

Model: OPTICA 20 Medical Device

REF XXXXX-NN-LLL 12 - 45 VDC / 24 VA


20 - 30 VAC / 35 VA, 50/60 Hz
SN WOXXXXXX/E-XX
Min. inherent filtration
YYYY-MM-DD 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

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 38/40 www.vareximaging.com
This page is deliberately left blank.

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 39/40 www.vareximaging.com
Contact details

Varex Imaging Nederland B.V. Varex Imaging Americas Corp.


The Netherlands USA
T +31 (0)315 659 150 T +1 847 279 5100
F +31 (0)315 659 140 F +1 630 271 9995
Netherlands.CNC@vareximaging.com Americas.CNC@vareximaging.com

Varex Imaging Technology (Beijing) Co., Ltd. Varex Imaging Philippines Inc.
China Philippines
T +86 10 6780 2708 T +63 49 5024 520
T +86 10 6780 2129 T +63 49 5024 521
F +86 10 6780 2170 F +63 49 5024 500
China.CNC@vareximaging.com F +63 2 80764 72
Philippines.CNC@vareximaging.com

© 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..

Technical Manual TM50590


Optica 20 series
Revision: 5.0
Date of release: 2019-03-26 40/40 www.vareximaging.com

You might also like