TM19894 - 8.0 (Technical Manual)

Harmony3 series
Docking station
Technical Manual
TM19894, Revision: 8.0 www.vareximaging.com

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Technical Manual: TM19894

Harmony3 series
Revision: 8.0
Date of release: 2019-04-10 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 ..............................................................................................7
1.4. Advisory...................................................................................................................................8
1.5. General warnings, cautions and notes ....................................................................................9
1.6. Symbols and markings on the device .................................................................................. 10
1.7. Supplied components ............................................................................................................ 11
2. Product description ......................................................................................................................... 12

2.1. INTENDED USE .................................................................................................................. 12
2.2. Description of the device ...................................................................................................... 12
2.3. Principle of operation ........................................................................................................... 12
2.4. Overview of the device ......................................................................................................... 13
Harmony3 and NR version ............................................................................................................. 13
The Harmony3 ST version ............................................................................................................. 14
Type recognition wall models ......................................................................................................... 15
2.5. Dimensions overview ........................................................................................................... 15
Harmony3 series and Harmony3 series NR version table model .................................................. 15
Harmony3 series and Harmony3 series NR version wall model .................................................... 16
Harmony3 series ST version .......................................................................................................... 16
2.6. Attenuation equivalence ....................................................................................................... 17
2.7. Restrictions on use ............................................................................................................... 17
2.8. ESSENTIAL PERFORMANCE ............................................................................................ 17
2.9. APPLIED PARTS ................................................................................................................. 17
2.10. Known contraindication(s) .................................................................................................... 17
2.11. Classifications ...................................................................................................................... 17
3. Operating instructions .................................................................................................................... 18

3.1. Switching the device ON and OFF ....................................................................................... 18
3.2. Functions during OPERATING MODE ................................................................................. 18
4. Installation ...................................................................................................................................... 19
4.1. Installation requirements ...................................................................................................... 19
4.2. Installation preparations ....................................................................................................... 19
4.3. Mounting instructions ........................................................................................................... 19
Harmony3 series and Harmony3 series NR version ...................................................................... 19
Harmony3 series ST version .......................................................................................................... 20
4.4. Electrical interface ................................................................................................................ 21
Harmony3 series ST versions ........................................................................................................ 21
Harmony3 series NR versions ....................................................................................................... 22
Harmony3 series rotating versions ................................................................................................. 23
4.5. Mounting a fixed grid ............................................................................................................ 24
4.6. Grid present indication ......................................................................................................... 25
4.7. Mounting an AEC-chamber .................................................................................................. 26
4.8. Detector present indication .................................................................................................. 27
4.9. Necessary recurrent testing ................................................................................................. 27

Harmony3 series
Revision: 8.0
5. Mains isolation ................................................................................................................................ 27
6. Service, maintenance and cleaning ............................................................................................... 28

6.1. Maintenance interval ............................................................................................................ 28
6.2. Maintenance checks ............................................................................................................ 28
6.3. Validation check ................................................................................................................... 28
6.4. Adjustments ......................................................................................................................... 28
6.5. Electrical system .................................................................................................................. 28
6.6. Parts list................................................................................................................................ 29
Harmony3 series and Harmony3 series NR version ...................................................................... 29
Harmony3 series ST table version ................................................................................................. 31
Harmony3 series ST wall version ................................................................................................... 32
6.7. Cleaning ............................................................................................................................... 32
6.8. Disinfection ........................................................................................................................... 32
7. Options ........................................................................................................................................... 33
8. ESD and EMC compatibility ........................................................................................................... 33

8.1. ESD ...................................................................................................................................... 33
8.2. EMC compatibility ................................................................................................................ 33
Deviations ....................................................................................................................................... 33
Allowances ..................................................................................................................................... 34
Precautions .................................................................................................................................... 34
Emissions Compliance ................................................................................................................... 34
Immunity Compliance ..................................................................................................................... 35
9. Disposal .......................................................................................................................................... 37
10. Specifications and accessories ................................................................................................. 37

10.1. Technical specifications ........................................................................................................ 37
10.2. Product label ........................................................................................................................ 38
10.3. Box label............................................................................................................................... 38
10.4. Accessories .......................................................................................................................... 39

Harmony3 series
Revision: 8.0
All rights reserved
Although this manual is prepared with utmost care, Varex Imaging Netherland B.V. cannot be held
accountable for errors or omissions.
Varex Imaging Netherland 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 Netherland 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.

Harmony3 series
Revision: 8.0
1. Introduction
1.1. Contact information
This manual provides all the technical information necessary for the correct installation, application
and maintenance of the Harmony3 series.
If you need additional information, need support or want to report a problem with the Harmony3 series,
please contact your distributor or Varex Imaging Netherland B.V.:
Manufacturer Distributor
Name Varex Imaging Netherland 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: Harmony 3 series
Part number: ______________________
Serial number: WO___________________
Part number and serial number can be found on the product label (see §10.2)

Harmony3 series
Revision: 8.0
1.2. Abbreviations
Term Definition
AEC Automatic Exposure Control

EMC Electromagnetic compatibility
ESD Electro Static Discharge
ME Medical Equipment
UM User Manual
TM Technical Manual
SolidStateMC Solid State Measuring Chamber
ST STationary
NR Non Rotating
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
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, actions 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.

Harmony3 series
Revision: 8.0
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 Harmony3 series.
Host system marking and/or certification (e.g. CE-marking, NRTL certification, etc.) can be affected by
installation of the Harmony3 series. Please consult the manufacturer of the host system for advice on
installation of the Harmony3 series.
Information regarding accidents that have occurred using the Harmony3 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 Harmony3 series in any way other than described in this
manual.
• Installation of the Harmony3 series which is not in accordance with the installation instructions
as provided.
• Use of the Harmony3 series other than the INTENDED USE.
• Installation of the Harmony3 series by SERVICE PERSONNEL that is not qualified.
• The Harmony3 series is not subjected to regular inspection and maintenance.
• Use of the Harmony3 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.

Harmony3 series
Revision: 8.0
1.5. General warnings, cautions and notes
WARNING:
Always connect the device to protective earth, using the dedicated terminal inside the
enclosure.
WARNING:
To avoid the risk of electric shock, this equipment must only be connected to a medical
grade power supply. (Depend on version)
WARNING:
Do not modify this equipment without authorization of the manufacturer.
WARNING:
When the exterior part(s) of the Bucky are removed, exposure to possible injury is
present.
WARNING:
When there is structural damage to the housing of the Harmony3 series or if the
Harmony3 series is malfunctioning, label the Harmony3 series as “out of order” and have
the Harmony3 series repaired prior to further use.
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:
The Harmony3 series shall only be used with specified conditions listed in §10.1
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 Harmony3 series or repair is needed, only original
replacement parts shall be used. Contact your distributor or Varex Imaging Nederland
B.V. for assistance.
WARNING:
Ensure that the device is powered OFF before opening Harmony3 series 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 large amount of different types of the Harmony3 series, the pictures used
may not always exactly represent the type of Harmony3 series 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.
Harmony3 series
Revision: 8.0
WARNING:
Service, maintenance and adjustments may only be executed by qualified SERVICE
PERSONNEL.
1.6. Symbols and markings on the device

Symbol Explanation
Manufacturer.
Date of manufacture.
Catalogue number.
Serial number.
CE-mark directive 93/42/EC.
Follow the instructions for use.

Reading the instructions for use is crucial for a correct and safe use of the Harmony3
series.
Identification of compliance with the provisions for EU WEEE directive.
IP20 This device has a protection class of IP20.
This device is a Type B Applied part.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Grid present and correctly inserted.
Detector Present and correctly inserted.
Detector in ‘landscape’ orientation.
Detector in ‘portrait’ orientation.

Harmony3 series
Revision: 8.0
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. Otherwise, you should immediately contact your distributor or
Varex Imaging Nederland B.V.. Use the original packaging during transport and for return shipments.
The transport box contains the following components:

Amount Description Reference
1 Harmony3 series Harmony3

Table model: 19407-NN & 19410-NN (**)
Wall model: 19408-NN & 19409-NN (**)
Harmony3 – ST version
Table model: 20947-NN & 20950-NN (**)
Wall model: 20948-NN & 20949-NN (**)
Harmony3 – NR version
Table model: 19386-NN & 19389-NN (**)
Wall model: 19387-NN & 19388-NN (**)
1 User Manual UM19893-NN (**)
1 Technical Manual TM19894
1 Mounting set for fixed grid Optional feature
1 Accessory kit Optional feature
(**): The catalogue number contains “NN”, which stands for a sequel number to define the
exact configuration within the applicable model, e.g. other handle, type of drawer, language etc.
The main functionality and information is applicable to all sequel numbers within the mentioned
catalogue number.

Harmony3 series
Revision: 8.0
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 be holding a image receptor.
The device is not intended to be used 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. Harmony3 series (also known as a Bucky) is a device which holds
an imaging device, such as a digital X-ray detector or film-based X-ray cassette.
The NR version differs from the base model in the following way: the detector can only be placed in a
fixed orientation on the drawer. It is not possible to change the orientation of the detector by rotating.
The ST version differs from the base model in the following way: the detector is mounted inside the
enclosure and cannot be removed by the operator.
The device also provides a slot for mounting a grid.
2.3. Principle of operation

The Harmony3 series is a component which is integrated in a regular X-ray system, used for RAD
diagnostic purposes and can be found at the following locations (depending on the version):
• Underneath the X-ray table top, in horizontal position. The device is intended to be integrated
in the table construction.
• Onto a wall stand, in vertical position. The Harmony3 series can also contain a cover to
position a patient against.
The main functionality of the Harmony3 series is to hold several components in order to make an X-
ray image. It contains a facility to mount/fix an AEC-chamber and a facility to place a grid (used for
reducing X-ray scattering) at the right position. Also, the Harmony3 series NR and ST version hold and
position a portable image receptor. This receptor is placed in a drawer-like construction which can be
pulled out and pushed in the enclosure. The Harmony3 series does not include any of these parts but
only operates as a holder for these components.

Harmony3 series
Revision: 8.0
2.4. Overview of the device
Harmony3 and NR version
The Harmony3 series and Harmony3 series NR version consists of three sections:
Wall Left: Wall Right:

1a
1b
1b
1a
Note: Images are for reference only.

1a The cover + related parts (Table model)
1b The cover + related parts (Wall model)
2 The Grid and AEC mounting rails (all models)
3 The Rotating Back (not available for the NR version)
The Grid and AEC Accept mechanism can accept one grid and one AEC (Automatic Exposure
Control) chamber.
Various types of grid or AEC can be mounted. Contact Varex Imaging Nederland B.V. for selecting the
correct AEC-chamber and/or grid.
Width Length Thickness
Grid 438 mm 480 mm 5.5 mm (max.)
AEC 450 - 470 mm 450 - 470 mm 6 mm (max., with 15mm thick detector)
The Harmony3 series functions also without a grid or AEC.

Harmony3 series
Revision: 8.0
The Harmony3 ST version
The Harmony3 series ST consists of:
1a
1a
1a The cover + related parts (Table model)

1b The cover + related parts (Wall models)
2 The Grid, Detector and AEC Accept (all models)
3 Cover plates + related parts (Table model)
The Grid and AEC Accept mechanism can accept one grid and one AEC (Automatic Exposure
Control) chamber.
Various types of grid or AEC can be mounted.
Description
SolidStateMC 501 (B3-C)

SolidStateMC 601
GRID, HMY3, GRIP, L52, R10F140, CARBON
NOTE:
Contact Varex Imaging Nederland B.V. for (other) available AEC-chambers and/or grids.
Depending on the ratio, focal distance and number of lines a long lead time could be
applicable.

Harmony3 series
Revision: 8.0
Type recognition wall models
The detector can be mounted/rotated between portrait and landscape mode. Except for the Harmony3
NR and ST version this is done rotating around its center or off center (optional feature).
The difference can be identified in the pattern on the cover:
Center rotation Off-center rotation
2.5. Dimensions overview

Harmony3 series and Harmony3 series NR version table model

Harmony3 series
Revision: 8.0
Harmony3 series and Harmony3 series NR version wall model
NOTE:
The length of the handle depends on the exact configuration within the catalogue
number. Different lengths and shapes are available.
Harmony3 series ST version

Wall Model Table Model

Harmony3 series
Revision: 8.0
2.6. Attenuation equivalence
The Harmony3 series covers have the following attenuation equivalents:
Table model 0.23 mm Al.
Wall model 0.32 mm Al.
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 Harmony3 series do not have essential performance.
2.9. APPLIED PARTS

In case of a wall model, the cover is an applied part and consists of ABS. This cover is classified as
type B applied part.
2.10. Known contraindication(s)

There are no known contraindications.
2.11. Classifications
Subject Classification Reference
Electrical safety classification Class I IEC 60601-1

Emission classification CISPR11; Group 1, Class A IEC 60601-1-2
Applied Part TYPE B IEC 60601-1
Mode of operation Continuous IEC 60601-1
Ingress protection classification IP20 IEC 60529
Not intended for use in Oxygen Rich environment.
Not suitable for Sterilization.

Harmony3 series
Revision: 8.0
3. Operating instructions
3.1. Switching the device ON and OFF
The Harmony3 series does not have a separate switch for switching the device on or off and is
operational when the entire X-ray system is powered on.
3.2. Functions during OPERATING MODE

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

Harmony3 series
Revision: 8.0
4. Installation
4.1. Installation requirements
The Harmony3 series must be installed and is intended for use in a regular X-ray system.
4.2. Installation preparations
Figure 1: Example of location red tie-wraps
1. Remove the cover from the enclosure.

2. Cut and remove the red cable ties which hold the detector drawer in its transport position (see
figure 1, not applicable for the ST version)
3. Re-mount the cover onto the enclosure once the device is fully installed.
4.3. Mounting instructions

Use the indicated holes as shown in the drilling template to mount the unit onto the X-ray system.
Harmony3 series and Harmony3 series NR version

Bottom view
CAUTION:
Always verify a deviating hole pattern with Varex Imaging Nederland B.V. before drilling
additional holes in the housing. Any additional holes may interfere with the inner
construction of the docking station.

Harmony3 series
Revision: 8.0
Side view (applicable for Table model):
CAUTION:
The M5 mounting screws may not intrude more than 5mm into the housing.
Harmony3 series ST version

Bottom view
CAUTION:
Always verify a deviating hole pattern with Varex Imaging Nederland B.V. before drilling
additional holes in the housing. Any additional holes may interfere with the inner
construction of the docking station.

Harmony3 series
Revision: 8.0
4.4. Electrical interface
Harmony3 series ST versions
The electrical interface is established with a 4-pins connector, located at the right hand lower corner of
the housing. A female connector is supplied to make the connection between the X-ray system and the
docking station.
Pin nr. Signal Remarks Ratings
1 Front grid switch Contact closed when grid is Max. 48VDC, 2A

present in housing. Detect if the
2 Front grid switch
grid is inserted.
3 Rear grid switch Contact closed when grid is Max. 48VDC, 2A
present in housing. Detect if the
4 Rear grid switch
grid is fully inserted.
CAUTION:
When Front grid switch is closed and Rear switch open the grid is not fully inserted and
the grid will be visible on the image when exposure is made.
Rear grid Switch

Front grid Switch

Harmony3 series
Revision: 8.0
Harmony3 series NR versions
The electrical interface is established with a 10-pins connector, positioned at the back corner of the
housing. A female connector is supplied to make the connection between the X-ray system and the
docking station.
1 Detector present contact 1 Contact closed when detector is Max. 48VDC, 2A

present in drawer.
2 Detector present contact 2
3 Front switch grid present contact Contact closed when grid is Max. 48VDC, 2A
1 inserted. Contact is open when
no grid is used.
4 Front switch grid present contact
2
5 Rear switch grid present contact Contact closed when grid is Max. 48VDC, 2A
1 inserted correctly (correct
position). Contact is open when
6 Rear switch grid present contact
no grid is used.
2
7* Grid identification contact 1 The switch can be used to Max. 48VDC, 2A
identify a specific grid. Contact
8* Grid identification contact 2 closed when grid with notch is
inserted correctly (correct
position).
9 Not used Not applicable
10 Not used
Pins marked with * are model type specific and may not be functional in your device.
NOTE:
The “Grid Present” function is equipped with two switches, giving the ability to indicate
when a grid is not fully inserted. In this case, the front grid switch is activated while the
rear grid switch is NOT activated.

Harmony3 series
Revision: 8.0
Harmony3 series rotating versions
The electrical interface is established with a 10-pins connector (green color), positioned at the back
corner of the housing. A female connector is supplied to make the connection between the X-ray
system and the docking station.
1 Ground
2 Power Supply 12-42VDC
3 DR Array Portrait contact 1 Contact closed when DR Array in Max. 48VDC, 2A
portrait position.
4 DR Array Portrait contact 2
5 DR Array Landscape contact 1 Contact closed when DR Array in Max. 48VDC, 2A
landscape position.
6 DR Array Landscape contact 2
7 Detector Present contact 1 Contact closed when detector is Max. 48VDC, 2A
present in drawer (either in
8 Detector Present contact 2
portrait or landscape position).
9 Grid Present contact 1 Contact closed when grid is Max. 48VDC, 2A
10 Grid Present contact 2
position). Contact is open when
no grid is used.
NOTE:
The “Grid Present” function is equipped with two switches:
• When a grid is present, but not positioned correctly all signals will be blocked
and the docking station will not pass-through any signals.
If the grid is positioned correctly or if there is no grid present the other signals (e.g.
“detector present”) will pass-through.
Optional, an additional switch is provided to determine if grid “A” or grid “B” is inserted. The switch will
be activated by applying a mounting kit onto the applicable grid. Contact Varex for more information on
this kit.
The table below gives more information about the connection of this second optional switch. Along
with the switch a female connector is supplied to make the connection between the X-ray system and
the docking station.
1 Grid identification contact 1 The switch can be used to Max. 48VDC, 2A

identify a specific grid. Contact
2 Grid identification contact 2 closed when grid with notch is
position).

Harmony3 series
Revision: 8.0
4.5. Mounting a fixed grid
CAUTION:
Be careful when handling a grid, if dropped the grid can be damaged. Resulting in a
negative effect on the image quality.
WARNING:
Ensure the docking station is unplugged and isolated before removing the cover.
Mount a fixed grid, if a removable grid is not required or if the “Varex Imaging Nederland B.V.
removable upgrade-kit” is not installed onto the grid.
Use “Mounting set, fixed grid” (Varex Imaging Nederland B.V. part number: 19071).
It contains the following:
• 4x set screws M3x6.
• 2x dowel pins Ø1.5x20.
Proceed as follows:
1. Remove the cover.

2. Slide the grid in between the black rails.
3. Place the two dowel pins (1) in the designated holes in the guide rails.
4. Pull the grid against the dowel pins to ensure correct positioning.

Harmony3 series
Revision: 8.0
5. Lock the grid with the four M3 set screws (2).
6. Remove the two dowel pins (1).
4.6. Grid present indication

The Harmony3 series is fine-tuned to indicate the applicable signals, including the grid present signal.
For more information regarding the electrical connection, see the tables in §4.4.
WARNING:
Check whether the grid present indication is working properly.
The blue LED (optional feature), indicating “grid present and inserted correctly” will switch on when the
grid switch (1) is closed (see picture below). This switch is sequence-connected with a switch at the
front of the device.

Harmony3 series
Revision: 8.0
4.7. Mounting an AEC-chamber
WARNING:
Ensure the docking station is unplugged and isolated before removing the cover.
2x ISO4762
M3x10/16,
each bracket
1. Remove the cover.

2. Release the four brackets by loosening both M3 bolts on each bracket (use hex key nr. 2.5).
This will create a space between the brackets and the black grid guide rail.
NOTE:
The maximum stroke of the screws is 6mm.
3. Use this space to position the measuring chamber below the rail and between the rail and the
bracket.
4. Align the measuring chamber with the X-ray beam.
5. Tighten the screws to fix the position.
NOTE:
When positioning the measuring chamber inside the docking station make sure the cable
does not interfere with any moving parts and/or components of the docking station.

Harmony3 series
Revision: 8.0
NOTE:
For thin models of measuring chambers additional silicon cushions, placed on the
brackets, are required to prevent the measuring chamber from moving. These silicon
cushions are provided in the accessory kit. Place the silicon cushions on the brackets as
shown in the following picture:
Before placing the silicon cushions, the brackets need to be cleaned and degreased.
4.8. Detector present indication

WARNING:
When inserting the detector, make sure the detector is detected correctly.
4.9. Necessary recurrent testing

There are no recurrent tests necessary for the Harmony3 series.
5. Mains isolation
WARNING:
Secondary circuits connected to the device shall comply to requirements of the IEC
60601-1 for separated from the mains supply by 2 Means Of Patient Protection
(2MOPP).
The Harmony3 series shall only be connected to secondary circuit voltages (See 4.4 for 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.

Harmony3 series
Revision: 8.0
6. Service, maintenance and cleaning
WARNING:
Service may only be executed by qualified SERVICE PERSONNEL.
Ensure that the device is unplugged and isolated before removing the cover to check the
inside of the docking station.
CAUTION:
When there is structural damage of the device, label the device as “out of order” and
have the device repaired prior to further use.
6.1. Maintenance interval

The device requires general maintenance and/or checks every 6 months.
6.2. Maintenance checks

Action Criteria
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 all mechanical switches
work correctly
- Verify output signals
Grid guide rails (not applicable for ST version) - Check on excessive wear
- Clean
- Fixed in place
Check rotating mechanism for drawer - No excessive wear, smooth operation
- Lubricate spring-loaded brass part with
some copper crease if required
6.3. Validation check

Run a validation test:
1. Take a reference X-ray image(photo).
2. Check and compare if the reference photo coincides with the expected result (e.g. initial
reference photo).
3.
6.4. Adjustments
There are no adjustments or special features applicable for this device.
6.5. Electrical system

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

Harmony3 series
Revision: 8.0
6.6. Parts list
Harmony3 series and Harmony3 series NR version

Harmony3 series
Revision: 8.0
Item nr. Description
1 Cover, Wall left/right, Center

Cover, Wall left/right, Off-center
2 Cover, Table
3 Drawer Base, several models available upon request
4 Sliding Base, Center (not for NR version)
Sliding Base, Off-Center (not for NR version)
5 Rotating Base, Clockwise (not for NR version)
Rotating base, Counter Clockwise (not for NR version)
6 Handle, several models available upon request
7 Grid Guide Rail
8 Grid Guide Rail
9 LED PCB, WL (not for NR version)
10 LED Front Sticker (not for NR version)
11 Drawer Slide Set
12 Main PCB (not for NR version)
A Grid (optional, several models available upon request)
B AEC (optional, several models available upon request)

Harmony3 series
Revision: 8.0
Harmony3 series ST table version
5
6
1 Cover Plate
2 Housing
3 Grid Guide Rail
4 Grid Guide Rail
5 Wire Harness
6 Blind Plate Front
7 Blind Plate Front
8 GRID optional several models available upon request

Harmony3 series
Revision: 8.0
Harmony3 series ST wall version
6
3
1 Cover, Wall right/left

2 Housing
3 Grid Guide Rail
4 Grid Guide Rail
5 Wire Harness
6 GRID optional several models available upon request
6.7. Cleaning
Cleaning with a damp cloth is recommended. Use neutral cleaning products and do not soak the
device with liquid.
6.8. Disinfection
Disinfection with a damp cloth with Isopropyl alcohol is recommended. Before using a disinfectant,
check at a spot on the bottom of the device if the disinfectant will not damage the plastic and coated
metal surfaces.
Do not soak the device with liquid.

Harmony3 series
Revision: 8.0
7. Options
Contact Varex Imaging Nederland B.V. for available options, e.g. AEC-chamber and/or grid.
NOTE:
For a grid, different FFD / Ratio versions are available on request. Depending on the
ratio, focal distance and number of lines a long lead time could be applicable.
8. ESD and EMC compatibility

8.1. 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.
8.2. 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 Harmony3 series, 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.

Harmony3 series
Revision: 8.0
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 Harmony3 series is intended for use in the electromagnetic environment specified below. The customer or user of the
Harmony3 series should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions group Group 1 The Harmony3 series uses RF energy only for its internal
CISPR 11 function. 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 Harmony3 series make it
CISPR 11 suitable for use in industrial areas and hospitals (CISPR 11 class
A). If it is used in a residential environment (for which CISPR 11
Harmonic emissions Not Applicable class B is normally required) this equipment might not offer
IEC 61000-3-2 adequate protection to radio-frequency communication services.
Voltage fluctuations/ Not Applicable The user might need to take mitigation measures, such as
flicker emissions relocating or re-orienting the equipment.”
IEC 61000-3-3

Harmony3 series
Revision: 8.0
Immunity Compliance
Guidance and manufacturer’s declaration – electromagnetic immunity – ENCLOSURE PORT
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.

Harmony3 series
Revision: 8.0
Guidance and manufacturer’s declaration – electromagnetic immunity – Power and Signal PORTs
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 Harmony3 series is intended to be supplied by an IEC
Line-to-line 60601-1 compliant 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 Harmony3 series is intended to be supplied by an IEC
IEC 61000-4-11 60601-1 compliant 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 Harmony3-NR is used exceeds the applicable RF
compliance level above, the Harmony3 series should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Harmony3 series .
NOTE
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people

Harmony3 series
Revision: 8.0
9. 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.
10. Specifications and accessories

10.1. Technical specifications
Classifications See § 2.11
Application Holding an image receptor, part of an X-ray system
Materials ABS, POM, stainless steel, aluminium
Power source (ST and NR version
12-42 [VDC] ± 10% / 24 [VA]
excluded)
Detector/Grid present contact Contact closed when detector/grid is present.
(Harmony3 series and NR version) Max. 48VDC, 2A
Grid detection contact Contact closed when grid inserted.
(Harmony3 series ST version) Max. 48VDC, 2A
±23 kg (Harmony3 series)
Weight
±12 kg (ST version only)
0.23[mm] @ 75[kV] (table models)
Al eq.
0.32[mm] @ 75[kV] (Wall models)
Table: 571x584x69mm (WxDxH)
Size
Wall: 610x610x77mm (WxDxH)
Ambient temperature: 10 – 40 °C
Operation environment Relative humidity: 10 – 75 %, non-condensing
Atm. Pressure: 690 – 1080 hPa
Ambient temperature: -10 – +70 °C
Storage Relative humidity: 10 – 90 %, non-condensing
Atm. Pressure: 690 – 1080 hPa
IEC 60601-1
IEC 60601-1-2
Applicable standards
IEC 60601-1-3
IEC 60601-2-54

Harmony3 series
Revision: 8.0
10.2. Product label
1 Anholtseweg 44
2
7091 HB Dinxperlo
The Netherlands Only
www.vareximaging.com
Medical Device
3 Model: XXXXXXXXXXXXXXXXXX
REF XXXXX-XX
4 SN WOXXXXXX/E-XX
IPXX
7
YYYY-MM-DD
5
(01)0XXXXXXXXXXXX(11)XXXXXX(21)WOXXXXXX/E-XX
6 This product complies with the requirements of 21 CFR Subchapter J for radiation emitting products in effect on the date of manufacture.
1 Manufacturer information
2 Space for applicable (IEC) symbols
3 Model name
4 Catalogue number
5 Serial number
6 Date of manufacture
7 IP classification
NOTE:
The product label as shown is representing the layout and accompanying explanation.
Look at the attached label to retrieve the actual and specific information of your device.
10.3. Box label
Only
Anholtseweg 44
7091 HB Dinxperlo
The Netherlands
www.vareximaging.com
Model: XXXXXXXXXXX Medical Device

REF XXXXX-XX
WOXXXXXX/E-XX
YYYY-MM-DD
(01)0XXXXXXXXXXXX
(11)XXXXXX
(21)WOXXXXXX/E-XX

Harmony3 series
Revision: 8.0
10.4. Accessories
The Harmony3 series is supplied without any accessories. The following accessory is available for the
removable grid functionality:
Amount Description
1 Upgrade kit, removable grid, 438x480mm (not applicable for ST version)
WARNING:
It is not allowed to use cable transducers along with the device.
It is not allowed to use other accessories along with the device.

Harmony3 series
Revision: 8.0
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
© 2019 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.

Harmony3 series
Revision: 8.0

TM19894 - 8.0 (Technical Manual)

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Harmony3 series

TM19894, Revision: 8.0 www.vareximaging.com

Technical Manual: TM19894

2. Product description ......................................................................................................................... 12

3. Operating instructions .................................................................................................................... 18

Technical Manual: TM19894

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

8. ESD and EMC compatibility ........................................................................................................... 33

10. Specifications and accessories ................................................................................................. 37

Technical Manual: TM19894

The warranty on your equipment will be void if:

Technical Manual: TM19894

Name Varex Imaging Netherland B.V.

Telephone +31 (0)315 659150

Fax +31 (0)315 659140

Model name: Harmony 3 series

Part number: ______________________

Serial number: WO___________________

Technical Manual: TM19894

AEC Automatic Exposure Control

1.3. Symbols used in this document

Technical Manual: TM19894

Technical Manual: TM19894

Requirements for SERVICE PERSONNEL

1.6. Symbols and markings on the device

CE-mark directive 93/42/EC.

Follow the instructions for use.

Identification of compliance with the provisions for EU WEEE directive.

IP20 This device has a protection class of IP20.

This device is a Type B Applied part.

Grid present and correctly inserted.

Detector Present and correctly inserted.

Detector in ‘landscape’ orientation.

Detector in ‘portrait’ orientation.

Technical Manual: TM19894

The transport box contains the following components:

1 Harmony3 series Harmony3

Technical Manual: TM19894

2.2. Description of the device

The device also provides a slot for mounting a grid.

2.3. Principle of operation

Technical Manual: TM19894

Wall Left: Wall Right:

Note: Images are for reference only.

Technical Manual: TM19894

1a The cover + related parts (Table model)

SolidStateMC 501 (B3-C)

Technical Manual: TM19894

Center rotation Off-center rotation

2.5. Dimensions overview

Technical Manual: TM19894

Harmony3 series ST version

Technical Manual: TM19894

2.7. Restrictions on use

2.8. ESSENTIAL PERFORMANCE

2.9. APPLIED PARTS

2.10. Known contraindication(s)

Electrical safety classification Class I IEC 60601-1

Technical Manual: TM19894

3.2. Functions during OPERATING MODE

Technical Manual: TM19894

4.2. Installation preparations

Figure 1: Example of location red tie-wraps