Planmeca ProOne Bedienungsanleitung

Printed copies of this document are considered uncontrolled.

7535.13.Rev001 08.07.2018

installation manual

10016257_3

Printed copies of this document are considered uncontrolled.

7535.13.Rev001 08.07.2018

Planmeca ProOne 1

TABLE OF CONTENTS

Installation Manual

1 INTRODUCTION ..............................................................................................1

2 PRE-INSTALLATION INFORMATION .............................................................2

2.1 Radiation protection ....................................................................................................... 2

2.2 Environmental requirements .......................................................................................... 3

2.3 Power requirements ....................................................................................................... 3

2.4 Digital system pre-installation information ..................................................................... 3

2.5 Dimensions for X-ray unit ............................................................................................... 6

2.6 Dimensions for wall bracket and extension plate (optional) ........................................... 7

3 CONTENTS OF THE PACKING ......................................................................8

3.1 Associated documentation ............................................................................................. 8

3.2 Mounting accessories .................................................................................................... 9

4 MAIN PARTS OF THE X-RAY UNIT ..............................................................10

4.1 General view of the system .......................................................................................... 10

4.2 General view of the X-ray unit ...................................................................................... 11

5 UNPACKING THE X-RAY UNIT ....................................................................12

6 INSTALLING THE X-RAY UNIT .....................................................................14

6.1 Attaching the X-ray unit to the wall .............................................................................. 14

6.2 Attaching the X-ray unit to the floor .............................................................................. 15

7 INSTALLING THE EXPOSURE SWITCH ......................................................18

7.1 Movable exposure switch ............................................................................................. 18

7.2 Stationary exposure switch .......................................................................................... 20

8 INSTALLING THE DIGITAL SYSTEM ...........................................................22

8.1 Connecting the Ethernet cable ..................................................................................... 22

8.2 Configuring the Ethernet link ........................................................................................ 23

8.3 Checking the Ethernet link communication .................................................................. 24

8.4 Installing the Dimaxis/Romexis imaging software ........................................................ 25

8.5 Installing the calibration files ........................................................................................ 25

9 CHECKING THE ALIGNMENTS ....................................................................26

9.1 X-ray beam ..................................................................................................................26

9.2 Taking a ball phantom exposure .................................................................................. 26

9.3 Patient positioning lights .............................................................................................. 26

10 DIAGRAMS ....................................................................................................27

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TABLE OF CONTENTS

2 Planmeca ProOne

Installation Manual

Planmeca 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.

Publication part number 10016257 Revision 3

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 author-

ized personnel

- electrical installations are carried out according to the appropriate requirements such

as IEC364

- equipment is used according to the operating instructions

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7535.13.Rev001 08.07.2018

Planmeca ProOne 1

Installation Manual

INTRODUCTION

1 INTRODUCTION

This manual contains all the information required to install and calibrate the Planmeca

ProOne X-ray unit. Please read this manual carefully before installing the X-ray unit.

NOTE You will also need the Planmeca ProOne X-ray unit’s Technical manual (publication

number 10016258) during installation. The instructions for adjusting the X-ray unit

are given in the Technical manual.

NOTE This manual also explains the Ethernet link configuration procedure. The Dimaxis/

Romexis software packages have separate installation manuals. You will also need

the Dimaxis/Romexis software User’s manual.

NOTE Required software versions:

- Planmeca ProOne software version 1.0.0.r or later

and one of the following

- Planmeca Dimaxis software version 4.3.1.0.r or later

- Planmeca Romexis software version 1.6.0.0.r or later

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PRE-INSTALLATION INFORMATION

2 Planmeca ProOne

Installation Manual

2 PRE-INSTALLATION INFORMATION

WARNING

DO NOT CONNECT ITEMS WHICH ARE NOT SPECIFIED AS

PART OF THE SYSTEM.

WARNING

THE X-RAY UNIT MUST BE CONNECTED TO A DEDICATED,

PROTECTIVELY GROUNDED POWER LINE (NO OTHER DEVICES

ARE CONNECTED TO THE SAME POWER LINE).

WARNING

DO NOT CONNECT A MULTIPLE PORTABLE SOCKET OUTLET

(MPSO) OR EXTENSION CORD TO THE SYSTEM.

NOTE The PC connected to the system must be:

- approved by local authorities: e.g. IEC-approved (CE marked), UL/CSA approved

- located outside the patient area (more than 2m (79 in.) from the X-ray unit) and

- protectively grounded.

NOTE External equipment intended for connection to signal input, signal output or other

connectors, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment

and the IEC 60601 series for medical electrical equipment). In addition, all such

combinations - systems - shall comply with the standard IEC 60601-1-1, Safety

requirements for medical electrical systems. Equipment not complying to IEC 60601

shall be kept outside the patient area (more than 2m (79 in.) from the X-ray unit).

Any person who connects external equipment to signal input, signal output or other

connectors has formed a system and is therefore responsible for the system to

comply with the requirements of IEC 60601-1-1.

NOTE EMC requirements have to be considered, and the equipment must be installed and

put into service according to the specific EMC information provided in the Technical

manual, section “EMC INFORMATION”.

NOTE Portable and mobile RF communications equipment can affect the Planmeca ProOne

X-ray unit. For minimum distance between portable and mobile RF communications

equipment and the Planmeca ProOne X-ray unit, see Technical manual, section “EMC

INFORMATION”.

NOTE Never place or hang any objects on any part of the X-ray unit.

NOTE Make sure that you cannot get caught or hooked up on any part of the X-ray unit.

Keep loose items of clothing, hair and jewellery tucked away safely.

2.1 Radiation protection

Protect yourself from radiation when you check the radiation beam alignment.

The room in which the X-ray unit is to be installed and the position from where the user is

to operate the equipment MUST be 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 safety regulations are met.

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PRE-INSTALLATION INFORMATION

WARNING

FAILURE TO INSTALL THE X-RAY UNIT IN AN APPROVED

LOCATION MAY BE DANGEROUS TO BOTH PATIENT AND

OPERATOR.

2.2 Environmental requirements

NOTE The X-ray unit must be installed in a location where the user can freely monitor the

patient during the whole imaging process. For minimum operational space

requirements, see section 2.5 “Dimensions for X-ray unit” on page 6.

2.2.1 Wall strength

The Planmeca ProOne X-ray unit must be attached to the wall prior use. Make sure that

the wall will support the X-ray unit. The wall bracket installation must be able to resist a

pull-out force of 2759 N (276 kg, 608 lb).

2.2.2 Temperature & Humidity

The operating temperature range is from +10°C to +40°C, non condensing. The

acceptable humidity range is from 15% to 85%. The transport and storage temperature

range is from 0°C to +50°C.

NOTE If the X-ray unit has been stored at temperatures below +10°C for more than a few

hours, time must be allowed for the unit to reach room temperature before

connecting it to the mains voltage.

2.3 Power requirements

Make sure that the power requirements of the X-ray unit are the same as the power that is

to be used. The X-ray unit is designed to operate using 100-240V~ universal power

supply. The power requirements are printed on a label which is attached to the mains

cable. They are also printed on the label located on the back of the moving column. If the

voltage is likely to fluctuate below 90V or over 264V you will need to install a UPS

(Uninterruptible Power Supply) between the mains supply and the X-ray unit to ensure

correct operation. The mains frequency can be either 50 or 60 Hz.

Make sure that there is a dedicated, grounded power outlet within 2.5 meters (8 feet) of

where the X-ray unit is to be installed.

CAUTION Never connect the X-ray unit to the mains without first checking the

voltage setting. Incorrect voltage setting can cause damage to the

unit electronics.

2.4 Digital system pre-installation information

The digital system consists of a Planmeca ProOne X-ray unit, Ethernet card, one or more

PCs and a Dimaxis/Romexis software package.

NOTE The PC and other equipment connected to the system must be:

- approved by local authorities: e.g. IEC-approved (CE marked), UL / CSA approved

- located outside the patient area (more than 2m (79 in.) from the X-ray unit) and

- protectively grounded.

2.4.1 Client PC system requirements

• Operating system

Windows XP, Windows 2000, Windows NT 4.0, Windows ME or Windows 98

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Installation Manual

•RAM

Dixi: Min. 256 MB, 1 GB recommended

ProOne: Min. 256 MB, 1 GB recommended

• Hard disk

50 MB free space required

• Processor

Intel Pentium or compatible, Pentium IV recommended

• Monitor and graphics card

SVGA monitor, resolution 1024 x 768 (or higher), 16 bit colors (or more)

•Bus

5 V PCI Slot for Dixi (not needed if Ethernet link is used)

• Network card

Ethernet min. 10 Mbit

2.4.2 PC data cable

• UTP cat5e Cable, Planmeca part number 06320060

NOTE The PC system must be equipped with a CD-ROM station and an empty PCI slot.

2.4.3 Server PC system requirements

• Operating system

Windows XP, Windows 2000 and Windows Server 2003

•RAM

Dixi: Min. 256MB, 1 GB recommended

ProOne: Min. 256MB, 1 GB recommended

• Hard disk

2x 80GB recommended

NOTE For data security reasons two physically separate hard disks must be installed!

• Processor

Intel Pentium III or compatible

• Monitor and graphics card

SVGA monitor, resolution 1024 x 768 (or higher), 16 bit colors (or more)

•Bus

5 V PCI Slot for Dixi (not needed if Ethernet link is used)

• Backup devices

MO drive, network drive or a third harddisk for long term archive

Tape backup device for backups

• Network card

Ethernet 10/100 Mbit

• PC data cable

UTP cat5e Cable, Planmeca part number 06320060

NOTE The PC system must be equipped with a CD-ROM station.

NOTE If a Planmeca Dixi system needs to be connected to the same PC together with the

ProOne/Ethernet configuration then a Hub/Switch is needed. Refer to Planmeca Dixi

User’s and Installation manual, publication number 688260.

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PRE-INSTALLATION INFORMATION

2.4.4 Server PC system setup

• This is how we recommend the system to be set up:

Operating System

Dimaxis/Romexis Software

* Windows 2000/NT/XP

* Solid program

* Solid log files

Solid Database

Backups

Hard Disk 1 (C:\; 80 GB) Hard Disk 2 (D:\; 80 GB)

(Physically different Hard Disk)

Magneto Optic Device Tape Backup Device

Long Time Archive

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PRE-INSTALLATION INFORMATION

6 Planmeca ProOne

Installation Manual

2.5 Dimensions for X-ray unit

The numbers given below are nominal, physical measurements of the X-ray unit.

The minimum operational space requirements are given in the table below the figure.

Minimum operational space requirements

Width Depth Height

Planmeca ProOne X-ray unit 1300 mm

51 in.

1300 mm

51 in.

2250 mm

89 in.

2230 mm

87.8 in.

1751.5 mm

69 in.

1832 mm

72.1 in.

800 mm 230 mm

31.5 in. 9.1 in.

571mm

394 mm

22.5 in.

15.5 in.

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7535.13.Rev001 08.07.2018

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