CEFLA RX DC User manual

cod. 97071214
rev. 05_18.12.2018
Stabilimento / Plant
Via Bicocca, 14/C - 40026 Imola (BO) - ITALY
Sede Legale ed Amministrativa / Headquarters
Cefla s.c. Via Selice Provinciale 23/A - 40026 Imola (BO) - ITALY
Supporto Tecnico / Technical Support
Tel.: [phone]
Fax: [phone]
[email protected]
RX DC Technical Manual

1
GB INSTALLATION
RX DC X-RAY UNIT
CONTENTS
1. GENERAL WARNINGS ......................................................................................................... 5
1.1 Foreword ........................................................................................................................................ 5
1.2 Safety instructions .......................................................................................................................... 5
2. PACKAGING........................................................................................................................... 6
2.1 Dimensions and contents ............................................................................................................... 6
2.2 Handling and storage ..................................................................................................................... 6
3. BEFORE INSTALLATION ..................................................................................................... 7
3.1 Environmental conditions ............................................................................................................... 7
3.2 Mechanical specications required................................................................................................. 7
3.3 Central control unit power supply .................................................................................................. 7
3.4 Wiring connection between central control unit and generator light ............................................. 8
4. INSTALLATION ...................................................................................................................... 9
4.1 Positioning the x-ray unit’s structure............................................................................................... 9
4.2 Wall-mounted plate for supporting the x-ray unit ............................................................................ 9
4.2.1 Vertical SINGLE STUD installation with wooden post ..................................................... 10
4.2.2 Horizontal SINGLE STUD installation with wooden post .................................................. 10
4.2.3 Vertical SINGLE STUD installation with iron post ............................................................ 10
4.3 Extension arm................................................................................................................................11
4.3.1 PASS THROUGH installation extension arm.................................................................... 12
4.4 Installing the trolley....................................................................................................................... 13
4.5 Installing the double pantograph arm .......................................................................................... 16
4.6 Installing the RX DC with "ball end socket joint" generator .......................................................... 18
4.7 Installing the RX DC with standard joint generator....................................................................... 18
4.8 Installing the collimator ................................................................................................................. 21
4.9 Balancing the double pantograph arm.......................................................................................... 22
4.10Adjusting the double pantograph arm end-stops.......................................................................... 22
4.11 Wall-mounted plate wiring connections ........................................................................................ 23

2GB
INSTALLATION
RX DC X-RAY UNIT
4.12Completion of wall-mounting plate and holder for handheld. ...................................................... 23
5. FACTORY SETTINGS.......................................................................................................... 26
6. TURNING ON AND FUNCTIONING OF THE DEVICE ..................................................... 26
6.1 Turning on the basic X-ray unit.................................................................................................... 26
6.2 Handheld Functions ..................................................................................................................... 27
6.3 Handheld display functions ......................................................................................................... 28
6.4 Use of handheld .......................................................................................................................... 29
6.5 X-RAY unit stand-by time.............................................................................................................. 30
6.6 Checking the parameters ............................................................................................................. 30
6.7 Factory settings ............................................................................................................................ 31
6.8 Positioning the X-ray head .......................................................................................................... 31
6.9 Position of the x-ray plate or sensor ............................................................................................. 32
6.10Procedure to be followed when taking the x-ray........................................................................... 33
7. TECHNICIAN AND USER SETUP MENU ......................................................................... 33
7.1 Setting the safety unlock mode .................................................................................................... 35
7.2 Setting the operating mode .......................................................................................................... 35
7.3 Setting the type of movable collimator ......................................................................................... 36
7.4 Calibrating the X-ray head ........................................................................................................... 36
8. ADJUSTING THE ACTUATOR UNIT (ONLY RX DC WITH "BALL END SOCKET
JOINT") ................................................................................................................................. 37
9. ELECTRONIC BOARDS...................................................................................................... 40
9.1 Power Board (Code 97661585).................................................................................................... 40
9.2 Basic X-ray head control card (Code 97661586) ........................................................................ 42
9.2.1 Replacing the basic X-ray head control card ................................................................... 44
10. X-RAY HEAD........................................................................................................................ 46
10.1Handheld unit-X-ray head association.......................................................................................... 46
10.2Setting the X-ray head in combination mode................................................................................ 47
10.3Send the recognition signal from the handheld unit to the X-ray head......................................... 47

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GB INSTALLATION
RX DC X-RAY UNIT
10.4Inspections and modications of Wi-Fi parameters on RX unit .................................................... 47
10.4.1 Change Wi-Fi settings..................................................................................................... 48
10.4.2 Forcing the Wi-Fi channel through DIP switches ............................................................ 49
10.5 Replacing the SLIP RING assembly (only RX DC with "ball end socket joint")........................... 49
11. ERROR CODES GIVEN ON THE HANDHELD ................................................................ 51
12. FIRMWARE UPDATE PROCEDURE.................................................................................. 54
13. ELECTRIC WIRING DIAGRAMS........................................................................................ 58
13.1REF. **P*****S ............................................................................................................................. 58
13.2REF. **X*****S REF. **E*****S...................................................................................................... 59
13.3REF. **P*****I................................................................................................................................ 60
13.4REF. **P*****I................................................................................................................................ 61
13.5REF. **P*****M.............................................................................................................................. 62
13.6REF. **X*****M - REF. **E*****M .................................................................................................. 63
14. PERIODICAL MAINTENANCE ........................................................................................... 64
15. RX DC WITH "BALL END SOCKET JOINT" / WITH STANDARD JOINT -
INSTALLATION CHECK LIST (FOR USA ONLY)............................................................. 65

4GB
INSTALLATION
RX DC X-RAY UNIT

5
GB INSTALLATION
RX DC X-RAY UNIT
1. GENERAL WARNINGS
1.1 Foreword
The device described in this manual is manufactured by CEFLA s.c. - via Selice Prov.le 23/A - 40026 Imola (BO) Italy,
a manufacturer complying with the European Directive on medical devices 93/42/EC (Class 2, B).
These instructions are intended for all the personnel who service and/or repair the Cea s.c. equipments. All the spe-
cic information required is provided.
IMPORTANT READ CAREFULLY BEFORE USE
KEEP FOR FUTURE REFERENCE
1.2 Safety instructions
All the safety instructions that help prevent any hazardous situations and operate the equipment in a trouble-free man-
ner are given in the user’s manual as explained below:
WARNING: This alert symbol indicates that the users and/or the patients run high risks and can be seriously inju-
red if the equipment or certain devices are used incorrectly or improperly, or the recommended safety precautions
are not taken to avoid hazardous situations.
CAUTION: Indicates that the operator is to take all the required precautions in order for all devices and/or
equipment to be used safely and e󰀩ciently.
When the equipment is received, check the packing container for any damage su󰀨ered. If evident damage is found,
immediately call the shipping agents and le a claim for damage. Carefully inspect the equipment for any missing or
damaged parts. For any complaints, immediately contact Cea s.c..
Cea s.c. shall be responsible for the reliability and e󰀩ciency of the equipment as well as the safety of the operating
personnel provided that:
• the installation, modications, settings or repairs are made by authorised persons using Cea s.c. original spare parts;
• the electrical wiring in the surgery complies with IEC 60364-7-710:2002 engineering regulations ( (Standards
regarding electrical systems in a medical environment) or equivalent standards currently in force in the country where
the equipment is installed).;
• the equipment is used as outlined in User’s Manual.
• the place where the x-ray unit is installed must comply with o󰀩cial directives regulating radiation in the country where
the equipment is used.

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GB
INSTALLATION
RX DC X-RAY UNIT
2.2 Handling and storage
Indications regarding storage, handling and unpacking are given on the outside of the cardboard packaging.
These indications must be strictly observed.
1) The package must be kept upright in the direction indicated by the arrows at all times
during handling and storage.
2) Avoid banging the package.
3) Keep the package free from damp.
4) Do not use hooks to handle the package.
5) A nameplate indicates the required ambient conditions for storage.
a) temperature from -15° to 50° C.
b) relative humidity from 10 to 90%
c) atmospheric pressure from 500 to 1060 hPa.
MOBILE STAND INSTALLATION
• N° 2 PACKAGES Dimensions: 103x53x36 cm
• 1ST PACKAGE Weight: 38 kg
• Contents 1ST PACKAGE:
- Documentation and guarantee
- Disposable jig for installation
- Kit
- Wall back-plate (if requested)
- Wall-mounted plate
- Generator
- Tube
- Extension
- Collimator
- Double pantograph arm
• 2ND PACKAGE WEIGHT: 30KG
• CONTENTS 2ND PACKAGE:
- Trolley mechanical parts
- general kit bag
2. PACKAGING
2.1 Dimensions and contents
WALL MOUNTED VERSION
• 1 PACKAGE Dimensions: 103x53x36 cm
• Weight: 38 kg
• Contents:
- Documentation and guarantee
- Disposable jig for installation
- Kit
- Wall back-plate (if requested)
- Wall-mounted plate
- Generator
- Tube
- Extension
- Collimator:
xRound collimator if eXTend version
xRound + rectangular collimator if HyperSphere
version
- Double pantograph arm

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GB INSTALLATION
RX DC X-RAY UNIT
3. BEFORE INSTALLATION
3.1 Environmental conditions
The equipment is to be installed in rooms that satisfy the following requirements:
• Temperature from +10 to +40° C.
• Relative humidity from 25 to 75% without condensate.
• Atmospheric pressure from 700 to 1060 hPa.
• The electrical wiring in the room in which the equipment is installed must conform to I.E.C. 60364-7-710;V2 specication
(i.e. the regulations concerning the electrical wiring to be used in surgeries) or equivalent standards in force in the
country where the equipment is installed.
3.2 Mechanical specications required
The wall-mount plate that supports the x-ray unit shall be securely xed to the wall.
If the wall is thin (hollow bricks or similar), use the backplate (part no. 9660048) to be mounted on the wall or placed on
the side of the wall opposite the wall where the unit is to be installed.
Decide on a suitable system for xing the plate according to the characteristics of the wall and its ability to resist a pull
force of 220 Kg applied at each anchorage point.
If the wall is made of cement or solid bricks, use the wall plugs supplied.
Alternatively we recommend using the “FISHER” chemical wall plugs which include:
• Braid type injection insert (item FIP 16X85).
• Threaded bar with bar and washer (item FIP 16M, 8X110).
• Chemical xer (item FIP C 150).
NOTE: Connection for remote handheld unit (For RXDC******C* models only)
If the 5m coiled cable of the handheld unit is not su󰀩cient to exit the room, it is necessary to provide a buried
wiring by preparing 3 0.5/1 sq.mm2wires with independent and separated canalisation (L<10m).
3.3 Central control unit power supply
- POWER SUPPLY:
230-240Vac 50-60Hz ATTENTION: RESPECT THE CORRECT CONNECTION POLARITY.
115-120Vac 50-60Hz
NOTE (1): verify that the voltage indicated on the name plate is suitable before attempting the connection.
NOTE (2): check that the fuse tted to protect the unit is correct for the power supply voltage, see installation manual.
- MINIMUM REQUIREMENT:
Power cord 3x2,5mm - The power cord must run at least 1 meter out of point (K).
The electrical wiring must be e󰀨ectively grounded in compliance with I.E.C. - us national electrical code - and C.E.I
standards (or in any case all current local standards).
In Italy the electrical wiring must be done in compliance with electrical code C.E.I. 64-8 sez.710, that require a di󰀨erential
switch with the following specications is installed before the system:
WITH POWER SUPPLY 230-240Vac, 50-60Hz WITH POWER SUPPLY 115-120Vac, 50-60Hz
NOMINAL CURRENT: 10A (BEND D)
DIFFERENTIAL SENSITIVITY: 0,03A
A CLEARANCE OF AT LEAST 3mm
NOMINAL CURRENT: 16A (BEND D)
DIFFERENTIAL SENSITIVITY: 0,03A
A CLEARANCE OF AT LEAST 3mm
The color of the 3 wires must be as set forth by the standards. If the di󰀨erential switch is found in a hard-to-reach area,
install another switch in a place that the operator can easily access.
- SIGNAL LAMP CONNECTION: Provide an independent power supply with 2 1.5mm wires. Use 2 0.5/1mm wires for
lamp control.

8GB
INSTALLATION
RX DC X-RAY UNIT
3.4 Wiring connection between central control unit and generator light
This connection enables the generator ready located outside the surgery to be turned on.
To connect the LP generator light (e) to the central control unit (c), use 2 conductors having a cross-section of 0.5 mm
(see section "Wall-mounted plate wiring connections").
LP light supply: 230V - 3x2.5 mm line.
Legenda:
a) SUPPLY LINE
b) CIRCUIT BREAKER 10 A
c) CENTRAL CONTROL UNIT
d) INTERLOCK
e) SIGNALLING LAMP