Planmed Clarity ™

EN

installation manual

20009439
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......................................................................................................................... 8
2.2.1 Mains voltage & frequency................................................................................................... 8
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......................................................................................................................... 9
2.3.1 Transportation...................................................................................................................... 9
2.3.2 Operation..............................................................................................................................9
2.3.3 Dimensions.........................................................................................................................10
2.4 Network requirements.................................................................................................................... 10
2.4.1 Required configuration....................................................................................................... 10
2.4.2 Technical specifications of network connection................................................................. 11
2.4.3 Intended information flow................................................................................................... 11
2.4.4 Hazardous situations resulting from network failure...........................................................11
2.5 Tools required.................................................................................................................................11
2.5.1 Tools for the mechanical installation.................................................................................. 11
2.5.2 Other tools..........................................................................................................................11
3 Unpacking mammography 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 mammography X-ray unit to operation position..................................................... 17
3.3.2 Driving mammography X-ray unit to transport position...................................................... 19
3.4 Unpacking accessories...................................................................................................................20
4 Installing mammography 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........................................................................................................... 34
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 Checking and calibrating the mammography X-ray unit.................................................................50
4.10 Checking and calibrating the FFDM system...................................................................................50
4.11 Installation verification.................................................................................................................... 50
4.12 Finalising installation...................................................................................................................... 50
5 Attachment of accessories........................................................................................................................52
5.1 Compression paddles and Bucky................................................................................................... 52

Installation manual Planmed Clarity

Table of contents

5.2 Exposure switch attachment...........................................................................................................52

5.3 Calibration running sign..................................................................................................................52
6 Diagrams.................................................................................................................................................. 53
6.1 Exposure switch, remote connection (EU, 20009934)................................................................... 53
6.2 Exposure switch, remote connection (US, 20009935)................................................................... 54
6.3 Wall exposure switch/lamp, remote connection (US, 20009932)................................................... 55
6.4 Wall exposure switch/lamp, remote connection (EU, 20009933)................................................... 56
6.5 Exposure switch/remote connection with external interlock (EU)...................................................57

Planmed Clarity Installation manual

 Table of contents

Installation manual Planmed Clarity

Table of contents

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 6
Released 06 August 2018

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
mammography X-ray units. Any features differentiating said systems or
mammography 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 Acquire Workstation, the
Review Workstation (optional), the Planmed Acquire/Review software, and
the Planmed Clarity Manager (incl. the calibration and Quality Control)
software package.
This manual contains the information required to install the Planmed Clarity
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.

Installation manual Planmed Clarity 1

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.

2 Planmed Clarity Installation manual

 1 Introduction

1.1 System main parts

The following figure shows the basic FFDM/DBT system setup and its main
parts.

Installation manual Planmed Clarity 3

1 Introduction

The following figure shows an optional FFDM/DBT system setup and its
main parts.

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

4 Planmed Clarity Installation manual

 1 Introduction

Item Cables, length (part number)

1. Review Workstation (RWS, optional) a) Detector Ethernet cable; 2.7 m (20008880)
2. Private network b) Control Ethernet cable; 2.7 m (20008880)
3. Medical grade isolation c) Foot control cable; 1.8 m (20000537)
4. Radiation shield d) Remote control cable; 3.5 m (20008286)
5. Planmed Wave acquisition desk (optional) e) Mains cable EU; 4.5 m (07827711)
6. 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.

Installation manual Planmed Clarity 5

2 Preinstallation requirements

2 Preinstallation requirements
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.

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.

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 mammography 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 should be used such as movable or
stationary radiation shields.

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 mammography X-ray unit. Please refer to local regulations.
However, protective operator shielding is always recommended, and should
always be used.

6 Planmed Clarity Installation manual

 2 Preinstallation requirements

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
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 mammography 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 mammography
X-ray unit.

NOTE
The distance from the computer, mammography 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 mammography 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 mammography X-ray unit has
four small feet in the base that can be adjusted to level the mammography
X-ray unit if the floor is uneven.
The mammography 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 +33°C (50°F to 91°F)
Operating humidity Up to 90% non-condensing
Storage temperature -20 °C to +70 °C (-4 °F to +158 °F)
Transportation temperature -20 °C to +70 °C (-4 °F to +158 °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.

Installation manual Planmed Clarity 7

2 Preinstallation requirements

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.

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.

8 Planmed Clarity Installation manual

 2 Preinstallation requirements

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.

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)

Installation manual Planmed Clarity 9

2 Preinstallation requirements

2.3.3 Dimensions

2.4 Network requirements

The mammography 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 Best Practices User's
Manual.
The mammography 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:
• IP address
• Subnet mask
• Gateway
• DNS
The hospital network firewall must be configured to allow connection
between workstation and hospital network

10 Planmed Clarity Installation manual

 2 Preinstallation requirements

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
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.

Installation manual Planmed Clarity 11

3 Unpacking mammography X-ray unit

3 Unpacking mammography X-ray unit

3.1 General about unpacking

NOTE
It is recommended that the room where the mammography 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 mammography X-ray unit when levelling it down to
the floor. The mammography 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 mammography X-ray unit.

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

3.2 Unpacking instructions

1. Move the mammography 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 mammography X-ray unit on its own wheels only when fine
tuning the installation location.

12 Planmed Clarity Installation manual

 3 Unpacking mammography X-ray unit

2. Remove the six pcs. of wood screws on the top of the crate cover. Lift
and remove the top cover (1). Unscrew the M10x120 screws (two pcs.)
going through the wooden support bar and attaching the mammography
X-ray unit from its transportation barrow handle to the crate (2).

Installation manual Planmed Clarity 13

3 Unpacking mammography 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).

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

14 Planmed Clarity Installation manual

 3 Unpacking mammography X-ray unit

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

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

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

installed.

Installation manual Planmed Clarity 15

3 Unpacking mammography X-ray unit

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

CAUTION
Avoid any concussions when moving the mammography X-ray unit.
Do not push the mammography X-ray unit over door steps or leave it
on a gradient plane.
• If only the mammography X-ray unit’s fixed wheels are used, you can
slightly move the mammography 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 mammography X-ray unit and the environment are
equal.

16 Planmed Clarity Installation manual

 3 Unpacking mammography X-ray unit

9. Remove the cover from the beam window.

3.3 Operation and transport positions

3.3.1 Driving mammography X-ray unit to operation position

CAUTION
Ensure that there is enough free space around the mammography 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.

1. Check and ensure that there is enough room for operating the
mammography X-ray unit in its intended operation position.

Installation manual Planmed Clarity 17

3 Unpacking mammography X-ray unit

2. Plug the mammography 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.
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
mammography X-ray unit up.
6. If you need to move the mammography X-ray unit after lifting the wheels
and removing locking knob, always lower the wheels, put locking knob
down and drive the mammography X-ray unit to the transport position as
described in section "Driving mammography X-ray unit to transport
position" on page 19.

18 Planmed Clarity Installation manual

 3 Unpacking mammography X-ray unit

3.3.2 Driving mammography X-ray unit to transport position

CAUTION
Never transport the mammography 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.

1. Attach the red locking knob to the base.

2. Enter the SERVICE menu.
1. Touch the mode selection icon (in the top right corner of the screen).
2. Touch the SERVICE & CONFIGURATION field and select the
Transportation tab.
3. Enter the PIN code.
3. Touch the Play button.

The mammography 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 mammography X-ray unit.

Installation manual Planmed Clarity 19

3 Unpacking mammography X-ray unit

5. Unplug the mammography 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
• 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

20 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

4 Installing mammography X-ray unit

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

4.1 Before starting the installation

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

4.2 Installation options

There are three installation options for the mammography X-ray unit,
depending on the ordered type of base delivery option. Select the type used
in the mammography 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
mammography 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
mammography X-ray unit for maintenance purposes, that is 90 cm (35
in.).
See instructions in section "Fixed short base installation" on page 34.
• 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

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

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

Installation manual Planmed Clarity 21

4 Installing mammography X-ray unit

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

22 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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.

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 plate and drill the ø12 mm (½ in.) holes
to the required depth of 45 mm (1.8 in.).
5. Clean the dust caused by the drilling from the holes with a vacuum
cleaner or with pressure air.

Installation manual Planmed Clarity 23

4 Installing mammography X-ray unit

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).

24 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

test kit as follows.
• Tighten the attachment screw until the surfaces of the test toll and
the screw are even.
• 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.
• Open the assembly.
• Check each (total 4 pcs.) expansion anchors in the same way as
described above.

1. Tighten the test kit to the floor 2. Wait for two minutes
2.1. Note that the surfaces must remain even for
two minutes
3. Test all the anchors. 4. Note the spring assembling direction: The
convex sides outwards
3.1. Test kit screw must not come up.

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.

Installation manual Planmed Clarity 25

4 Installing mammography X-ray unit

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

26 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

Installation manual Planmed Clarity 27

4 Installing mammography X-ray unit

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

28 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

1. Allen screw M10 x 25 DIN 912 for concrete, 2. Turnable base

brick etc. construction
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).

Installation manual Planmed Clarity 29

4 Installing mammography X-ray unit

13. Raise the mammography 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.

14. Remove the delivery base.

1. On both sides, unscrew the two attachment screws.

30 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

2. Remove the delivery base by lifting it.

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

Installation manual Planmed Clarity 31

4 Installing mammography X-ray unit

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

17. Adjust both wheels to upper position.

32 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

19. Remove the Base Rear Cover and attach the mammography X-ray unit
to the turnable base plate with one M10x30 DIN 912 (8.8) screw (2), and
two M10x60 DIN 912 (8.8) screws using two M10 DIN 125 washers (3).

Installation manual Planmed Clarity 33

4 Installing mammography X-ray unit

20. Adjust/tighten the front base brackets.

21. Install front base mask plugs.

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

4.4 Fixed short base installation

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

34 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

1. Move the mammography 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.
3. Place the rear assemby bar (2005730) under the back of the unit so that
the holes are aligned.

Installation manual Planmed Clarity 35

4 Installing mammography X-ray unit

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

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

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

36 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

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 (10x40 mm) into the holes and hammer the
wedge using a 10 mm drift and a hammer.

Installation manual Planmed Clarity 37

4 Installing mammography X-ray unit

11. Check the attachment of each expansion anchor by using the supplied
test kit as follows.
• Tighten the attachment screw until the surfaces of the test toll and
the screw are even.
• 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.
• Open the assembly.
• Check each (total 4 pcs.) expansion anchors in the same way as
described above.

1. Tighten the test kit to the floor 2. Wait for two minutes
2.1. Note that the surfaces must remain even for
two minutes
3. Test all the anchors. 4. Note the spring assembling direction: The
convex sides outwards
3.1. Test kit screw must not come up.

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 mammography X-ray unit back to the marked position.

38 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

13. Adjust both wheels to upper position.

Installation manual Planmed Clarity 39

4 Installing mammography X-ray unit

14. Attach the fixed support base with two M10x30 mm DIN912 (8.8) screws
in the back of the mammography X-ray unit. The screws should hit M10
holes of the rear assembly bar.

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 M10x80mm DIN7984 (8.8) screws located in front of the
mammography X-ray unit.

16. Reattach the Base Power PCB assembly with five screws.
17. Remove the delivery base.

40 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

1. On both sides, unscrew the two attachment screws.

2. Remove the delivery base by lifting it.

Installation manual Planmed Clarity 41

4 Installing mammography X-ray unit

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

19. Adjust/tighten the front base brackets.

42 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

20. Install front base mask plugs.

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

4.5 Free standing base installation

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

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

1. Move the mammography X-ray unit now into its defined position.

Installation manual Planmed Clarity 43

4 Installing mammography X-ray unit

2. Remove the C-arm locking knob from the free standing base.

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

1. Mark the position of the floor fixation screw hole through the C-arm
locking knob hole to the floor.
2. Move the mammography X-ray unit from its position.
3. Drill a hole (10 mm diameter) until the depth is about 30 mm.
4. Clean the dust caused by the drilling of the hole.
5. Place the expansion anchor to its position and hammer the wedge
with a 6 mm drift and hammer (see figure below).
6. Move the mammography X-ray unit back to its position.
7. Adjust both wheels to upper position and adjust the mammography
X-ray unit straight using the levelling feet.
8. Attach the free standing base with M8x30 mm DIN912 (8.8) screw
with washer (see figure below) to the floor.

44 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

1. Cover plug 2. M8x30 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.

Installation manual Planmed Clarity 45

4 Installing mammography X-ray unit

5. Adjust both wheels to upper position.

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

4.6 Installation stability check

Check the stability of the mammography X-ray unit attachment. The
mammography X-ray unit must stay in its position when it is pulled forward
as described below.
• Drive the C-arm to the upright position, see section "Operation and
transport positions" on page 17

46 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

• Go behind the mammography X-ray unit and ensure no one can be

injured in case the machine tips over during this test.
Push the mammography 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:
• Detector Ethernet cable from base to corresponding Ethernet port in
AWS PC
• Control Ethernet cable from base to corresponding Ethernet port in AWS
PC
• Foot control Cables; for more information, see the mammography X-ray
unit user's manual
• Remote control cable for exposure switch; for more information, see
section "Diagrams" on page 53
Connect the following additional cables (optional):

Installation manual Planmed Clarity 47

4 Installing mammography X-ray unit

• Optional External Interlock; for more information, see section "Diagrams"

on page 53
• 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
53

4.8 Installing and configuring the AWS PC

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

1. Connect monitor, mouse, keyboard, two Ethernet cables from the

mammography X-ray unit and one Ethernet cable from customer network
to 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. 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.

48 Planmed Clarity Installation manual

 4 Installing mammography 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.
The password is clarity. This user has been assigned administrator
rights.
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 mammography X-ray unit must be switched
on to receive temperature.
8. Check from the Windows task manager that Wibukey is running.

1. Press CTRL+ALT+DEL.
2. Choose Task Manager.
3. 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 [email protected].
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 in order 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.

Installation manual Planmed Clarity 49

4 Installing mammography X-ray unit

4.9 Checking and calibrating the mammography X-ray unit

1. Check all the regional and initial set-ups from the mammography 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.

4.10 Checking and calibrating the FFDM system

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.

4.11 Installation verification

After the installation has been completed:
• 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
• Send the images to DICOM nodes that were configured earlier; check
that the images transfer properly

4.12 Finalising installation

• Clean the graphic user interface of fingerprints

50 Planmed Clarity Installation manual

 4 Installing mammography X-ray unit

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

• Have the unit checked by local authorities if needed; apply local

regulations

Installation manual Planmed Clarity 51

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 53.
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 53.

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 mammography X-ray unit automatically perfoms a certain
amount of exposures during the calibration sequence. For more information,
see the mammography X-ray unit user’s manual.

52 Planmed Clarity Installation manual

 6 Diagrams

6 Diagrams
6.1 Exposure switch, remote connection (EU, 20009934)

Installation manual Planmed Clarity 53

6 Diagrams

6.2 Exposure switch, remote connection (US, 20009935)

54 Planmed Clarity Installation manual

 6 Diagrams

6.3 Wall exposure switch/lamp, remote connection (US, 20009932)

Installation manual Planmed Clarity 55

6 Diagrams

6.4 Wall exposure switch/lamp, remote connection (EU, 20009933)

56 Planmed Clarity Installation manual

 6 Diagrams

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

Installation manual Planmed Clarity 57

 Planmed Oy | Sorvaajankatu 7 | 00880 Helsinki | Finland
tel. +358 20 7795 300 | fax +358 20 7795 664 | [email protected] | www.planmed.com