Planmed Clarity ™

EN

installation manual
The manufacturer, assembler and importer are responsible for the safety, reliability and
performance of the unit only if:
- installation, calibration, modification and repairs are carried out by qualified
authorised personnel
- electrical installations are carried out according to the appropriate requirements such
as IEC 60364
- equipment is used according to the operating instructions.
Planmed pursues a policy of continual product development. Although every effort
is made to produce up-to-date product documentation this publication should not be
regarded as an infallible guide to current specifications. We reserve the right to make
changes without prior notice.
COPYRIGHT PLANMED
Publication number 20009439 Revision 13
Released 23 October 2023
Table of contents

1 Introduction................................................................................................................................................. 1
1.1 System main parts............................................................................................................................3
2 Preinstallation requirements....................................................................................................................... 6
2.1 Environmental requirements.............................................................................................................7
2.1.1 Strength requirement for the floor.................................................................................... 7
2.1.2 Temperature, humidity, atmospheric pressure.................................................................7
2.2 Power requirements......................................................................................................................... 7
2.2.1 Mains voltage & frequency...............................................................................................7
2.2.2 Fuse ratings..................................................................................................................... 8
2.2.3 Mains impedance and earthing........................................................................................ 8
2.2.4 Typical power consumption..............................................................................................8
2.3 Space requirements......................................................................................................................... 8
2.3.1 Transportation.................................................................................................................. 8
2.3.2 Operation......................................................................................................................... 9
2.3.3 Dimensions...................................................................................................................... 9
2.4 Network requirements...................................................................................................................... 9
2.4.1 Required configuration..................................................................................................... 9
2.4.2 Technical specifications of network connection............................................................. 10
2.4.3 Intended information flow............................................................................................... 10
2.4.4 Hazardous situations resulting from network failure...................................................... 10
2.5 Tools required.................................................................................................................................10
2.5.1 Tools for the mechanical installation.............................................................................. 10
2.5.2 Other tools......................................................................................................................11
3 Unpacking X-ray unit................................................................................................................................ 12
3.1 General about unpacking............................................................................................................... 12
3.2 Unpacking instructions................................................................................................................... 12
3.3 Operation and transport positions.................................................................................................. 17
3.3.1 Driving X-ray unit to operation position.......................................................................... 17
3.3.2 Driving X-ray unit to transport position........................................................................... 18
3.4 Unpacking accessories...................................................................................................................19
4 Installing X-ray unit................................................................................................................................... 21
4.1 Before starting the installation........................................................................................................ 21
4.2 Installation options..........................................................................................................................21
4.3 Turnable base installation...............................................................................................................21
4.4 Fixed short base installation........................................................................................................... 35
4.5 Free standing base installation.......................................................................................................43
4.6 Installation stability check............................................................................................................... 46
4.7 Connecting system cables..............................................................................................................47
4.8 Installing and configuring the AWS PC...........................................................................................48
4.9 Registering PC............................................................................................................................... 50
4.10 Checking and calibrating the X-ray unit..........................................................................................53
4.11 Checking and calibrating the FFDM system...................................................................................54
4.12 Installation verification.................................................................................................................... 54
4.13 Finalising installation...................................................................................................................... 54
5 Attachment of accessories........................................................................................................................56

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Table of contents

5.1 Compression paddles and bucky................................................................................................... 56

5.2 Exposure switch attachment...........................................................................................................56
5.3 Calibration running sign..................................................................................................................56
6 Diagrams.................................................................................................................................................. 57
6.1 Exposure switch, remote connection (EU, 20009939)................................................................... 57
6.2 Exposure switch, remote connection (US, 20009940)................................................................... 58
6.3 Wall exposure switch/lamp, remote connection (EU, 20009937)................................................... 59
6.4 Wall exposure switch/lamp, remote connection (US, 20009938)................................................... 60
6.5 Exposure switch/remote connection with external interlock (EU)...................................................61
6.6 Wall exposure switch with exposure pedal.....................................................................................62

Planmed Clarity Installation manual

 1 Introduction

1 Introduction
NOTE
This manual applies to both the Planmed Clarity 2D/3D Full Field Digitial
Mammography (FFDM) and to the Digital Breast Tomosynthesis (DBT)
systems, which are further in the text jointly referred to as FFDM/DBT
system, while the respective FFDM/DBT X-ray units are referred to as X-ray
units. Any features differentiating said systems or X-ray units from each
other are specified further in the text.

The FFDM/DBT system consists of the Planmed Clarity mammography

X-ray unit equipped with the Flat Panel Detector; the Planmed Clarity
Acquisition Workstation, the Planmed Review Workstation (optional), the
Planmed Acquisition/Review software, and the Planmed Clarity Manager
(incl. the calibration and Quality Control) software package.
This manual contains the information required to install the X-ray unit.

NOTE
The installation of the software to the workstations is described in their own
manuals.

NOTE
Read this manual carefully before installing the Planmed Clarity
mammography X-ray unit.

NOTE
You will also need the Planmed Clarity 2D/3D X-ray unit’s technical manual
during installation. The adjustment and calibration instructions of the Full
Field Flex AEC are given in the technical manual.

NOTE
To calibrate the flat panel detector and perform the quality control protocol of
the mammography X-ray unit, you need the Planmed Clarity user’s manual
and Planmed Clarity Quality Control Manual.

NOTE
Changes in the IT-network may result in previously unidentified risk. Be sure
to identify, evaluate and control risks before making changes. Changes to
the IT-network include:
• Changes in the IT-network configuration
• Connection of additional items to the IT-network
• Disconnecting items from the IT-network
• Update and upgrade of equipment connected to the IT-network

CAUTION
FAILURE TO INSTALL THE MAMMOGRAPHY X-RAY UNIT IN AN
APPROVED LOCATION MAY BE DANGEROUS TO BOTH PATIENT AND
OPERATOR. THE USE OF THE MAMMOGRAPHY X-RAY UNIT IN AN
INAPPROPRIATE LOCATION MAY BE DANGEROUS.

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1 Introduction

CAUTION
IT IS VERY IMPORTANT THAT THE ROOM IN WHICH THE
MAMMOGRAPHY X-RAY UNIT IS INSTALLED AND THE POSITION
FROM WHICH THE USER OPERATES THE EQUIPMENT ARE
CORRECTLY SHIELDED FROM RADIATION. SINCE RADIATION SAFETY
REQUIREMENTS VARY FROM COUNTRY TO COUNTRY AND STATE TO
STATE IT IS THE RESPONSIBILITY OF THE INSTALLER TO ENSURE
THAT ALL LOCAL SAFETY REGULATIONS ARE MET.

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 1 Introduction

1.1 System main parts

The following figure shows the basic FFDM/DBT system set-up and its main
parts.

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1 Introduction

The following figure shows an optional FFDM/DBT system set-up and its
main parts.

The FFDM/DBT system includes the following main elements, see the
figures above and the table below.

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 1 Introduction

Item Cables, length (part number)

1. Planmed Review Workstation (RWS, a) Detector Ethernet cable; 2.7 m (20008880)
optional) b) Control Ethernet cable; 2.7 m (20008880)
2. Private network c) Foot control cable; 1.8 m (20000537)
3. Medical grade isolation d) Remote control cable; 3.5 m (20008286)
4. Planmed Radiation Shield e) Mains cable EU; 4.5 m (07827711)
5. Planmed Wave acquisition desk (optional)
6. Planmed Clarity Acquisition Workstation
(AWS)
7. Clarity Isolation Transformer (CIT)
8. Mammography X-ray unit

NOTE
In order to avoid excess patient leakage currents the AWS must be isolated
from the local area network with a medical grade isolation device.

NOTE
Only Clarity Isolation Transformer (CIT) provided by Planmed is allowed to
be used.

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2 Preinstallation requirements

2 Preinstallation requirements
CAUTION
Failure to install the X-ray unit in an approved location may be dangerous
to both patient and operator. The use of the X-ray unit in an inappropriate
location may be dangerous.

CAUTION
It is very important that the room in which the X-ray unit is installed and the
position from which the user operates the equipment are correctly shielded
from radiation. Since radiation safety requirements vary from country to
country and state to state it is the responsibility of the installer to ensure
that all local safety regulations are met.

CAUTION
Do not connect items which are not specified as part of the system.

CAUTION
We recommend that you install an Uninterruptable Power Supply (UPS) to
support the AWS and the X-ray unit in the event of power failure.

NOTE
Only workstations provided by Planmed may be used in the AWS.

NOTE
Always use Clarity Isolation Transformer (CIT) between mains and the AWS
power input.

NOTE
The connection of additional equipment to a multiple portable socket-outlet
must only be possible by using a tool or be supplied via separating
transformer.

The multiple portable socket-outlets shall not be placed on the floor.

No additional safety measures during the system installation are required.
The system is recommended to be installed in a way that enables the user to
achieve the optimal use.

Radiation protection
The radiation safety regulations of individual countries must be complied
with. Radiation protection devices, such as movable or stationary radiation
shields, should be used .

Safe distances without specific shielding

A few exposures (without additional radiation shielding) can be made without
exceeding the mR/hour per month limit, if the operator distance is far enough
from the X-ray unit. Please refer to local regulations. However, protective
operator shielding is always recommended and should always be used.

Wall lead equivalence

The lead equivalence of the walls in the room depends on the material used,
please refer to local radiation protection regulations. A recommended safe

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 2 Preinstallation requirements

value of the wall lead equivalence (mmPb) is ≥1 mm and should cover even
the most strict requirements.

Movable shields
Radiation shields are also available.

2.1 Environmental requirements

It is necessary to bolt the X-ray unit to floor if a free standing base is
not used. Apply local regulations. For more information, refer to section
"Installation options" on page 21.
Two persons are ALWAYS needed for the installation of the X-ray unit.

NOTE
The distance from the computer, X-ray unit and AWS to water supplies,
sinks or other water sources has to be minimum 1.5 m.

2.1.1 Strength requirement for the floor

The weight of the X-ray unit (approx. 185kg) is moderate and does not
cause any special requirements for the carrying capacity of the floor.
However, certain hardness and strength is required to keep the bolts firmly in
the floor. Read the floor testing instructions carefully, see section "Turnable
base installation" on page 21.
The floor must be straight within 0.5%. The X-ray unit has four small feet in
the base that can be adjusted to level the X-ray unit if the floor is uneven.
The X-ray unit should never be placed on thick carpets for stability and
reliability reasons. Antistatic floor materials should be preferred.

2.1.2 Temperature, humidity, atmospheric pressure

Environmental factor Tolerance range
Operating temperature +10°C to +35°C (50°F to 95°F)
Operating humidity Up to 90% non-condensing
Storage temperature 0 °C to +60 °C (32 °F to +140 °F)
Transportation temperature 0 °C to +60 °C (32 °F to +140 °F)
Atmospheric pressure range 700 hPa to 1060 hPa
The maximum deviation of the calibration temperature is ±7°C (45°F).

NOTE
It is recommended that the room where the mammography X-ray unit is
installed has an operating temperature conditioning system. The optimal
temperature setting for unit is 24°C.

2.2 Power requirements

2.2.1 Mains voltage & frequency

Nominal operating voltage can be 208 VAC – 240 VAC 50/60 Hz, either
between the phases or between one phase and neutral.

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2 Preinstallation requirements

2.2.2 Fuse ratings

The minimum recommended external fuse rating is 15 AT (time-lag).
Electromagnetic circuit breakers can be used, since the X-ray unit’s power
factor is >0.95. The mammography X-ray unit is also protected internally with
15 AT fuses.

2.2.3 Mains impedance and earthing

To ensure proper operation over the recommended mains voltage range, the
resistance of the mains should not exceed 0.5 Ω. The X-ray unit must be
connected to an earthed outlet.

2.2.4 Typical power consumption

The idle power consumption of the mammography X-ray unit is less than
250 VA. The maximum power consumption is in worst case 4500 VA for a
maximum of 5 seconds at 33 kV / 97 mA exposure settings.

2.3 Space requirements

2.3.1 Transportation
The mammography X-ray unit can be transported through door openings
that are minimum of 78 cm (31 in.) wide.

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 2 Preinstallation requirements

2.3.2 Operation
The following table provides the absolute minimum space requirements of
the mammography X-ray unit operation site.

Dimension Minimum
Height 218 cm (86 in)
Width 153 cm (61 in)
Depth 110 cm (44 in)

2.3.3 Dimensions

2.4 Network requirements

The X-ray unit requires a network connection for the purposes of connecting
with Health Information Services (HIS) and the Picture Archiving and
Communication System (PACS).
For more information on network security measures and requirements, see
the cyber security section of the Planmed Clarity Cyber Security - Best
Practices user's manual.
The X-ray unit requires a connection to the hospital network. The
recommended minimum connection speed is 100 Mb/s.

2.4.1 Required configuration

The following workstation network adapter settings must be set during
installation:

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2 Preinstallation requirements

• IP address
• Subnet mask
• Gateway
• DNS
The hospital network firewall must be configured to allow connection
between workstation and hospital network.

Default configuration values

The factory default configuration values are as follows for the workstation
network adapters.
Control:
• IPv4 Address: [Link]
• Subnet Mask: [Link]
Detector:
• IPv4 Address: [Link]
• Subnet Mask: [Link]
Network:
• DHCP

2.4.2 Technical specifications of network connection

• Gigabit Ethernet (IEEE 802.3 10/100/1000BASE-T)
• Minimum requirements: CAT5 cable with RJ45 connector

2.4.3 Intended information flow

All network connections between the mammography X-ray unit and the
network are blocked by the firewall, excluding the following protocols that
require a connection to the hospital network:

Process Protocol
Patient and Study information from RIS DICOM Modality Worklist
Sending images to PACS DICOM Storage
Retrieving images from PACS DICOM Query/Retrieve
Printing images DICOM Print
Notice to HIS/RIS: DICOM MPPS
Study started / ended / cancelled

2.4.4 Hazardous situations resulting from network failure

None.

2.5 Tools required

2.5.1 Tools for the mechanical installation

• Standard set of screwdrivers
• Millimetre-based Allen keys
• Motorised screwdriver

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 2 Preinstallation requirements

A motorised screwdriver is recommended for opening the packaging crate.

2.5.2 Other tools

For more information on the test instruments needed for installation
verification, refer to the mammography X-ray unit technical manual.

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3 Unpacking X-ray unit

3 Unpacking X-ray unit

3.1 General about unpacking

NOTE
It is recommended that the room where the X-ray unit is unpacked and
installed has an operating temperature conditioning system. Refer to section
"Environmental requirements" on page 7.

NOTE
Be careful not to drop the X-ray unit when levelling it down to the floor. The
X-ray unit is quite heavy (185 kg / 408 lbs) and must be handled by a strong
person(s). It is recommended to have at least two persons when moving the
X-ray unit.

NOTE
NEVER lift the X-ray unit from the C-arm or hood. When handling the X-ray
unit, lift the X-ray unit from the metal base and/or the transportation handle.

3.2 Unpacking instructions

Steps
1. Move the X-ray unit in its transportation package to the final installation
location or at least as close as possible to the final installation location.

NOTE
Move the X-ray unit on its own wheels only when fine tuning the
installation location.
2. Remove the six pcs. of wood screws on the top of the crate cover.
Lift and remove the top cover (1). Unscrew the M10 x 120 screws (two
pcs.) going through the wooden support bar and attaching the X-ray unit
from its transportation barrow handle to the crate (2).

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 3 Unpacking X-ray unit

3. Remove wood screws around the back plates and remove the side
plates (3).
Remove the cardboard and the accessory box(es) from the crate. Place
the wooden support bar next to the transportation crate and the removed
cover on the floor next to the crate as a side ramp (4).

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3 Unpacking X-ray unit

4. Remove all screws which are attaching the base on the bottom of the
crate (5).
Also remove the wooden rear support bar (6).

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 3 Unpacking X-ray unit

5. Adjust the X-ray unit’s fixed wheels to the low position for transporting
the X-ray unit to its installation place.

6. If ordered, attach the extra wheels to the handle with M10x25 screws (7).

7. Move the X-ray unit to the location where it is going to be installed.

• If the transport barrow handle kit, i.e. extra wheels are used, lower
the X-ray unit on its back so that the wheels of the delivery barrow
handle are touching the ground, see the figure below.

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3 Unpacking X-ray unit

CAUTION
Avoid any concussions when moving the X-ray unit. Do not push the
X-ray unit over door steps or leave it on a gradient plane.

• If only the X-ray unit’s fixed wheels are used, you can slightly move
the X-ray unit with them, when fitting it into the final installation place.
8. Wait at least three hours before continuing the installation so that the
temperature of the X-ray unit and the environment are equal.
9. Remove the cover from the beam window.

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 3 Unpacking X-ray unit

3.3 Operation and transport positions

3.3.1 Driving X-ray unit to operation position

Before you begin

CAUTION
Ensure that there is enough free space around the X-ray unit so that
the C-arm does not hit any obstacles during the movement. To stop the
C-arm in an emergency situation, press the emergency STOP button or the
compression foot controls.

Steps
1. Check and ensure that there is enough room for operating the X-ray unit
in its intended operation position.
2. Plug the X-ray unit to a mains (208—240V~) outlet and switch it on.

After short period of self tests, the unit control panel automatically
displays the SERVICE menu in the Transportation tab and requires a
PIN code.

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3 Unpacking X-ray unit

3. After entering the PIN code, the following screen appears.

4. To activate the normal use mode, touch the Play button.

5. Remove red locking knob from the base and lift the wheels from X-ray
unit up.
6. If you need to move the X-ray unit after lifting the wheels and removing
locking knob, always lower the wheels, put locking knob down and drive
the X-ray unit to the transport position as described in section "Driving
X-ray unit to transport position" on page 18.

3.3.2 Driving X-ray unit to transport position

Before you begin

CAUTION
Never transport the X-ray unit without first driving it down to the transport
position. Use the delivery base with the locking knob to prevent the C-arm
from moving during transportation.

Steps
1. Attach the red locking knob to the base.
2. Enter the SERVICE menu.
2.a. Touch the mode selection icon (in the top right corner of the
screen).
2.b. Click on the SERVICE field and select the Transportation tab.
2.c. Enter the PIN code.

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 3 Unpacking X-ray unit

3. Touch the Play button.

The X-ray unit drives to the transportation mode.

Wait until the automatic drive stops. Drive the C-arm manually down so
that it is supported by the red locking knob.
4. Switch off the X-ray unit.
5. Unplug the X-ray unit from the mains power and detach the Ethernet
cables.

3.4 Unpacking accessories

The following minimum set of accessories should be found inside the crate,
in every shipped mammography X-ray unit, depending on the model.

Mammography X-ray unit 2D:

• Large 24 x 30 Paddle
• Clarity Bucky 24x30
• Remote exposure connector set
• Transportation barrow handle / delivery base

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3 Unpacking X-ray unit

• Chin guard
• Mammography X-ray unit user’s manual on USB stick
• Mammography X-ray unit installation and technical manual on USB stick
• X-ray warning sign (20005878)
• Calibration toolkit

Mammography X-ray unit 3D:

• Large 24 x 30 Paddle
• Tomosynthesis 24 x 33 Paddle
• Clarity Bucky 24x30
• Clarity Tomosynthesis platform
• Remote exposure connector set
• Transportation barrow handle / delivery base
• Chin guard
• Mammography X-ray unit user’s manual on USB stick
• Mammography X-ray unit installation and technical manual on USB stick
• X-ray warning sign (20005878)
• Calibration toolkit

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 4 Installing X-ray unit

4 Installing X-ray unit

The following sections describe the installation of the X-ray unit.

4.1 Before starting the installation

Before starting the installation, the following preconditions must be met:
• The X-ray unit is transported to the final installation site
• The X-ray unit and accessories are unpacked from the transportation
package
• The X-ray unit is in the transportation position and C-arm in the FB
position
• The X-ray unit is switched off
• The X-ray unit’s electric cable is unplugged.

4.2 Installation options

There are three installation options for the X-ray unit, depending on the
ordered type of base delivery option. Select the type used in the X-ray unit to
be installed below and follow the instructions in the referred section.
• Turnable base installation
ALWAYS use this method when there is not enough space behind the
X-ray unit for maintenance purposes, for example, if there is a wall right
behind the unit.
See instructions in section "Turnable base installation" on page 21.
• Fixed short base installation
This method can be used ONLY if there is enough space behind the
X-ray unit for maintenance purposes, that is 90 cm (35 in.).
See instructions in section "Fixed short base installation" on page 35.
• Free standing base installation
This method can be used if no bolting to the floor is desired or possible.
See instructions in section "Free standing base installation" on page 43.

4.3 Turnable base installation

Before you begin

CAUTION
It is necessary to have at least two persons to perform a secure installation
of an X- ray unit.

NOTE
The X-ray unit with a turnable base must ALWAYS be bolted on the floor.
Check the stability of the X-ray unit after installation.

NOTE
The floor has to fulfil the strength requirements. For more information see
section "Strength requirement for the floor" on page 7.

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4 Installing X-ray unit

Steps
1. Remove the turnable base plate with 6-mm Allen key.

2. Place the turnable base plate min. 100 mm (4 in.) away from the wall.
Check that the plate positioned parallel to the wall. Use the base plate as
a template to mark the positions of the corners of the base support plate.

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 4 Installing X-ray unit

3. Drill shallow starting holes with a ø12 mm (½ in.) drill bit, using the base
support plate as a template.

4. Remove the base support plate and drill the ø12 mm (½ in.) holes to the
required depth of 45 mm (1.8 in.).
5. Clean the drill dust from the holes with a vacuum cleaner or with
pressure air.
6. Place the expansion anchors on their positions and hammer the wedge
with a 10-mm drift and hammer.

NOTE
The anchor's wedge has to be hammered firmly to the bottom. Use the
delivered M10 8 mm (0.32”) drift (code 20003550).

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4 Installing X-ray unit

7. Check the attachment of each expansion anchor by using the supplied

test kit as follows.
7.a. Tighten the attachment screw until the surfaces of the test toll and
the screw are even.
7.b. Wait for 2 minutes and check that the screw has stayed on the
SAME level.

CAUTION
If the screw has moved then the floor is NOT strong enough.
7.c. Open the assembly.
7.d. Check each (total 4 pcs.) expansion anchors in the same way as
described above.

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 4 Installing X-ray unit

7.e. Tighten the test kit to the floor (1).

7.f. Wait for two minutes (2).

Note that the surfaces must remain even for two minutes (2.1).
7.g. Test all the anchors (3).
The test kit screw must not come up (3.1).
7.h. Note the spring assembling direction: the convex sides outwards
(4).

CAUTION
If one of the holes fails the test, then it is possible to drill a new hole in
one of the alternative points. Note that four secure holes is an absolute
minimum.

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4 Installing X-ray unit

8. Adjust the plate with the help of spirit level and with the multi-use wrench
key so that the turnable base is horizontal.

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 4 Installing X-ray unit

9. Attach the turnable base back to the X-ray unit.

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4 Installing X-ray unit

10. Move the X-ray unit now into its defined position (where the screw holes
are located) and lift the X-ray unit up.

11. Lower the base support plate a little by turning the multi-use wrench
counter clockwise.
Turn the whole X-ray unit 90° clockwise and turn the base to its marked
position. Attach the base support plate lightly from the joint axle screw to
the floor. Lower the base plate again by turning the multi-use wrench key
so that it is touching the floor. Align the holes and the corners of the base
support plate and attach it lightly to the floor.

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 4 Installing X-ray unit

12. Attach the base support plate to the inserts in the floor using all the four
M10x25 DIN 912 (8.8.) screws.

1. Allen screw M10 x 25 DIN 912 for concrete, brick etc. construction
2. Turnable base
3. Concrete
4. Expansion anchor M10 Ø 12 x 40

NOTE
Tighten the screws to torque 7—8 Nm with the torque wrench or turn the
key 1/4 rounds more with an Allen key after the screw has reached the
bottom. This corresponds roughly to 8 Nm).
13. Raise the X-ray unit by turning the multi-use wrench tool.
Lift the axle side wheel up so it can move freely.
Lower the opposite side wheel clockwise until it hits the floor.

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4 Installing X-ray unit

14. Remove the delivery base.

14.a. On both sides, unscrew the two attachment screws.

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14.b. Remove the delivery base by lifting it.

15. Remove the transport barrow handle and place the cover plugs to the
empty screw holes.

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4 Installing X-ray unit

16. Turn the X-ray unit back to its position.

17. To ensure the proper movement of the turnable base, turn the X-ray unit
to the service position and back the operation position.

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18. Adjust both wheels to the upper position.

19. Lower the X-ray unit by turning the multi-use wrench.

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4 Installing X-ray unit

20. Remove the Base Rear Cover and attach the X-ray unit to the turnable
base plate with one M10 x 30 DIN 912 (8.8) screw (2), and two M10 x 60
DIN 912 (8.8) screws using two M10 DIN 125 washers (3).

21. Adjust/tighten the front base brackets.

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 4 Installing X-ray unit

22. Install the front base mask plugs.

23. Continue installation from section "Installation stability check" on page

46.

4.4 Fixed short base installation

Before you begin

CAUTION
It is necessary to have at least two persons to perform a secure installation
of a X- ray unit.

NOTE
The X-ray unit with a fixed short base must ALWAYS be bolted on the floor.
Check the stability of the X-ray unit after installation.

NOTE
The floor has to fulfil the strength requirements. For more information, see
section "Strength requirement for the floor" on page 7.

Steps
1. Move the X-ray unit exactly to its final location.
Check that it is parallel to the wall and that the MINIMUM distance from
the wall is at least 900 mm (35 in.).
2. Loosen the four screws of the Base rear cover (two located near to the
On/Off switch and two on the other end of the plate), and detach the
cover by lifting it up.
Make sure the mains cord is not connected to the mains and On/Off
switch is in Off position.
Open the screws behind the Base Power PCB assembly so that you can
access the attachment hole.

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4 Installing X-ray unit

3. Place the rear assembly bar (2005730) under the back of the unit so that
the holes are aligned.

4. Mark the place of the rear assembly bar on the floor.

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 4 Installing X-ray unit

5. Use the fixed base as a template and mark the positions of the front
fastening holes to the floor.

6. Remove the X-ray unit from its position.

7. Mark the holes of the rear assembly bar to the floor.

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NOTE
Check that the bar is in its position according to the marks on the floor.
8. Remove the plate and drill the ø12 mm (½ in.) holes to the required
depth of 45 mm (1.8 in.).

NOTE
Use two front holes and two from the assembly bar (preferably the holes
near each end of the bar.) If the drilling is not successful it can be redone
using the spare holes.
9. Clean the dust caused by the drilling from the holes with a vacuum
cleaner or with pressure air.
10. Insert the expansion anchors (10 x 40 mm) into the holes and hammer
the wedge using a 10 mm drift and a hammer.
11. Check the attachment of each expansion anchor by using the supplied
test kit as follows.
11.a. Tighten the attachment screw until the surfaces of the test toll and
the screw are even.
11.b. Wait for 2 minutes and check that the screw has stayed on the
SAME level.

CAUTION
If the screw has moved then the floor is NOT strong enough.
11.c. Open the assembly.
11.d. Check each (total 4 pcs.) expansion anchors in the same way as
described above.

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11.e. Tighten the test kit to the floor (1).

11.f. Wait for two minutes (2).

Note that the surfaces must remain even for two minutes (2.1).
11.g. Test all the anchors (3).
Test kit screw must not come up (3.1).
11.h. Note the spring assembling direction: the convex sides outwards
(4).

CAUTION
If one of the holes is failing the test, then it is possible to drill a new
hole one of the alternative holes. Note that four secure holes is a definite
minimum.
12. Move the X-ray unit back to the marked position.

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13. Adjust both wheels to upper position.

14. Attach the fixed support base with two M10 x 30 mm DIN912 (8.8)
screws in the back of the X-ray unit.
The screws should hit M10 holes of the rear assembly bar.

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NOTE
Tighten the screws to torque 7—8 Nm with the torque wrench or turn the
key ¼ rounds more with an Allen key after the screw has reached the
bottom. This corresponds roughly to 8 Nm.
15. Attach the two M10 x 80mm DIN7984 (8.8) screws located in front of the
X-ray unit.

16. Reattach the Base Power PCB assembly with five screws.
17. Remove the delivery base.
17.a. On both sides, unscrew the two attachment screws.

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17.b. Remove the delivery base by lifting it.

18. Remove transport barrow handle and place the cover plugs to the empty
screw holes.

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19. Adjust/tighten the front base brackets.

20. Install front base mask plugs.

21. Continue installing from section "Installation stability check" on page 46.

4.5 Free standing base installation

Before you begin

CAUTION
It is necessary to have at least two persons to perform a secure installation
of a X- ray unit.

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4 Installing X-ray unit

NOTE
The X-ray unit with a free standing base can optionally be bolted to the floor.
The stability of the X-ray unit must be checked after installation.

NOTE
The floor has to fulfil the strength requirements. For more information, see
section "Strength requirement for the floor" on page 7.

Steps
1. Move the X-ray unit now into its defined position.
2. Remove the C-arm locking knob from the free standing base.

3. Optionally, if floor fixation is used, follow the sub-steps below:

3.a. Mark the position of the floor fixation screw hole through the C-
arm locking knob hole to the floor.
3.b. Move the X-ray unit from its position.
3.c. Drill a hole (10 mm diameter) until the depth is about 30 mm.
3.d. Clean the dust caused by the drilling of the hole.
3.e. Place the expansion anchor to its position and hammer the wedge
with a 6-mm drift and hammer (see figure below).
3.f. Move the X-ray unit back to its position.
3.g. Adjust both wheels to upper position and adjust the X-ray unit
straight using the levelling feet.
3.h. Attach the free standing base with M8 x 30 mm DIN912 (8.8)
screw with washer (see figure below) to the floor.

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3.i. Attach the cover plug to the C-arm locking knob hole (see figure
below).

1. Cover plug
2. M8 x 30 mm DIN912 (8.8) screw
3. Washer
4. Expansion anchor
4. Remove transport barrow handle and place the cover plugs to the empty
screw holes.

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5. Adjust both wheels to upper position.

6. Continue installing from section "Installation stability check" on page 46.

4.6 Installation stability check

About this task

Check the stability of the X-ray unit attachment. The X-ray unit must stay in
its position when it is pulled forward as described below.

Steps
1. Drive the C-arm to the upright position.
See section "Operation and transport positions" on page 17.
2. Go behind the X-ray unit and ensure no one can be injured in case the
machine tips over during the test.

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3. Push the X-ray unit from the C-arm back cover at the height of 1600 mm
(63 in.) with a force of at least 220 N (22kg, 50 lbf).

4.7 Connecting system cables

Connect the following cables to the mammography X-ray unit, ports located
on the base.

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4 Installing X-ray unit

1 Detector Ethernet cable from base to corresponding

Ethernet port in the AWS PC
2 Control Ethernet cable from base to corresponding
Ethernet port in the AWS PC
3 and 4 Foot control cables (left and right)
5 Remote control cable for exposure switch
6 (optional) Exposure pedal cable
For more information on the exposure switch connections, see section
"Diagrams" on page 57.
Connect the following additional/optional cables, if needed:
• Optional External Interlock
• For more information, see section "Diagrams" on page 57.
• External Exposure warning light can be connected to Base Interface
PCB.
The relay can take a maximum voltage of 240 VAC and a maximum
current of 10 A. For more information, see the mammography X-ray unit
technical manual.
• An optional external exposure warning light can also be connected to
certain exposure switches.
For more information, see section "Diagrams" on page 57

4.8 Installing and configuring the AWS PC

Before you begin

NOTE
If you have the Planmed Wave acquisition desk, see the Planmed Wave
acquisition desk installation and technical manual for installation instructions.

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Steps
1. Connect the monitor, mouse and keyboard cables, the two Ethernet
cables from the X-ray unit, and the Ethernet cable from the customer
network to the AWS PC.

NOTE
Always use the provided medical grade isolator when connecting the
AWS PC to customer network.
2. Check that the USB dongle(s) are in place in the USB ports behind the
AWS PC.
Note, if the X-ray unit is delivered with only CORE processing algorithm,
no dongle(s) are found. Otherwise, in the 2D system you should have 1
USB dongle and with the 3D system you should have 2 USB dongles.
3. Connect the Clarity Isolation Transformer (CIT) to mains power and
connect Clarity AWS PC and Monitor to the CIT output.
4. Turn on the CIT, AWS PC and X-ray unit.
5. Check that the AWS PC and the X-ray unit start up without any errors.
6. By default, one user account called "Planmed" is defined in AWS PC.
This user has been assigned administrator rights.
The passwords are delivered with the X-ray unit in a paper sheet.
If the passwords are not found, contact the Planmed After sales
(aftersales@[Link]).
7. Planmed Clarity Manager starts automatically after entering the Planmed
user account.
Check from the lower right corner that the temperature from the detector
appears after a couple of minutes.
If the temperature does not appear, check the Ethernet cables between
X-ray unit and AWS PC. The X-ray unit must be switched on to receive
temperature.
8. Check from the Windows task manager that Wibukey is running.
Note, if CORE processing algorithm for 2D imaging is used, skip this
step and continue from Step 9.

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4 Installing X-ray unit

8.a. Press CTRL+ALT+DEL.

8.b. Choose Task Manager.
8.c. Check that WkSvMgr displays on the Background processes and
Startup listings.
9. Go to Clarity Manager Support and press Info and About. Check that the
license includes all the options you have ordered. If the license is wrong,
contact licensing@[Link].
10. Set the DICOM settings from the Planmed Clarity Manager DICOM tab.
11. Set the IP address in the windows network and sharing centre for
network adapter called Network to connect to customer network.

NOTE
Do not change the IP address for Control or Detector network adapters.
12. Set up user groups and users in Planmed Clarity Manager as instructed
in the mammography X-ray unit technical manual.

4.9 Registering PC

Before you begin

Mandatory registration of every new Dell computer is required for full
warranty and Dell Pro Support technical service. The following section
describes the steps needed to register the Dell computer included in
mammography X-ray units.

NOTE
When filling in the new owner’s contact details, remember to enter Company
Name: Planmed.

NOTE
The following procedure must be performed separately for each device.

Steps
1. To transfer the ownership, go to Dell ownership transfer website:
[Link]

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2. On the web page, select Single product and enter the service tag of the
device to be transferred.
The service tag for the Dell PC is is located on top of the PC.

After entering the service tag to the Dell website, click Continue.
3. On the next page, fill in the following previous owner information:
• Company Name: Planmed
• First Name: Finland
• Last Name: Planmed
• Zip Code: 00880

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4 Installing X-ray unit

After filling in the details, press Continue.

4. The next page requests the intended use information for the device.
Choose the most suitable option from the drop down menu.

5. Once the intended use is selected, the next page displays the full list of
details to be filled.
Fill in the contact details of the new owner.

NOTE
The company name still needs to be Planmed.

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After entering the required information, click Continue.

6. Follow the prompts to a review page, and check that the filled
information is correct.

7. Proceed to confirmation by clicking Continue.

Results
After confirmation, transfer of ownership is complete.

4.10 Checking and calibrating the X-ray unit

Steps
1. Check all the regional and initial set-ups from the X-ray unit as instructed
in the mammography X-ray unit technical manual.
2. Verify the compression force measurement as instructed in the
mammography X-ray unit technical manual.
3. Perform all the movement calibrations as instructed in the
mammography X-ray unit technical manual.
4. Calibrate the X-ray tube filament pre-heating voltage as instructed in the
mammography X-ray unit technical manual.
5. Check that the MaxView Modules work correctly, if included in the
delivery.

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4.11 Checking and calibrating the FFDM system

Steps
1. Create a test patient and start a study in Planmed Clarity Manager at
Local Study Archive.
Check that the study can be started without any errors.
2. Perform the field size calibration as instructed in the mammography
X-ray unit technical manual.
3. Perform the field size verification as instructed in the mammography
X-ray unit technical manual.
4. Perform the prepulse calibration(s) as instructed in the mammography
X-ray technical manual.
5. Perform the 2D calibrations as instructed in the mammography X-ray unit
user's manual.
6. Perform 2D related quality control as instructed in the Planmed Clarity
Quality Control Manual.
7. Perform the calibrations and quality control for magnification as
instructed in the mammography X-ray unit technical manual and
Planmed Clarity Quality Control Manual, only if magnification option is
delivered with the system.
8. Perform the calibrations and quality control for tomosynthesis as
instructed in the mammography X-ray unit technical manual and
Planmed Clarity Quality Control Manual, only if tomosynthesis option is
delivered with the system.
9. Perform the tests, configuration, calibration and quality control for Clarity
Guide unit as instructed in the mammography X-ray unit technical
manual, only if the Clarity Needle Guide option is delivered with the
system.

4.12 Installation verification

About this task

Follow these steps to perform installation verification after the installation has
been completed.

Steps
1. Create a patient and take a test image with 2D, magnification (optional)
and tomosynthesis (optional), and make sure no watermarks are seen in
the images.
2. Send the images to DICOM nodes that were configured earlier; check
that the images transfer properly.

4.13 Finalising installation

Steps
1. Clean the graphic user interface of fingerprints.

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2. Check that the chin guard and all the other covers are in place, including
base covers.

3. Have the unit checked by local authorities if needed; apply local

regulations.

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5 Attachment of accessories

5 Attachment of accessories
5.1 Compression paddles and bucky
Refer to the mammography X-ray unit user’s manual for instructions on how
to insert the compression paddle and the bucky.

5.2 Exposure switch attachment

NOTE
There are two different exposure switch options:
• Hand held exposure switch
• Fixed wall exposure switch
The wall exposure switch can be equipped with an additional exposure lamp.

Always place the exposure switch in a location that is shielded from

radiation. Local radiation safety regulations might include a requirement for
visual contact between the patient and the operator. Take local radiation
safety regulations into account when finding a proper location for the
exposure switch.
Connect the exposure switch to the mammography X-ray unit with the
supplied cables as instructed in section "Diagrams" on page 57.
Attach the cable to the wall or install a cable channel. Never let the cable lie
on the floor where it can be damaged.

External interlock
It is also possible to use an external interlock within the exposure switch/
remote connection. The external interlock can be used to disable the
exposure when, for example, a door to the mammography X-ray unit room is
opened.

NOTE
If external interlock is used, the function must be clearly indicated with a sign
near the mammography X- ray unit and/or the interlock triggering item.

For more instructions on connecting the exposure switch/lamp remote

connection with or without external interlock, see electrical diagrams in
section "Diagrams" on page 57.

5.3 Calibration running sign

Check that the Calibration running warning sign is available. During
calibration hang the Calibration Running sign on the calibration room door.
Make sure that the X-ray unit automatically performs a certain amount of
exposures during the calibration sequence. For more information, see the
mammography X-ray unit user’s manual.

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6 Diagrams
6.1 Exposure switch, remote connection (EU, 20009939)

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6 Diagrams

6.2 Exposure switch, remote connection (US, 20009940)

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6.3 Wall exposure switch/lamp, remote connection (EU, 20009937)

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6.4 Wall exposure switch/lamp, remote connection (US, 20009938)

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6.5 Exposure switch/remote connection with external interlock (EU)

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6.6 Wall exposure switch with exposure pedal

FEX2 J2 DIP-switch

DIN-5 cabling inside FEX2

EXPIN Brown
EXPOUT White
RDYIND Grey
EXPIND Green

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 Planmed Oy | Sorvaajankatu 7 | 00880 Helsinki | Finland
tel. +358 20 7795 300 | fax +358 20 7795 664 | sales@[Link] | [Link]