Professional Documents
Culture Documents
TM50590 - 5.0 (Technical Manual)
TM50590 - 5.0 (Technical Manual)
Technical Manual
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
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
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.
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:
Part number:
Part number and serial number can be found on the product label (see §9.2)
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
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.
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.
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.
WARNING:
Service, maintenance and adjustments may only be executed by qualified SERVICE
PERSONNEL.
Manufacturer
Date of manufacture
Catalogue number
Serial number
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
Be advised by your distributor or Varex Imaging Nederland B.V. for any accessories available.
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.
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.
B
E
D
A C
NOTE:
The operating panel may contain customized features (e.g. color, print layout, …)
NOTE:
The dimensions for the top shutters are valid with shutters set at maximum opening.
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
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.
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.
Disconnect
Faston-
connector
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.
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“).
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.
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.
WARNING:
Check if the input voltage corresponds with the connected terminals.
WARNING:
Risk of Fire, do not connect + LOW and + HIGH simultaneously.
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.
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
After successful result of the verification checks mentioned above the collimator is ready for 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.
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.
6.6. 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
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
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.
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.
WARNING:
When the flange locks are untightened make sure the collimator is supported.
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.
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
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
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.
Anholtseweg 44
7091 HB Dinxperlo
The Netherlands 0120 Only
www.vareximaging.com 710383
Anholtseweg 44
7091 HB Dinxperlo
The Netherlands 0120 Only
www.vareximaging.com 710383
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