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FONA X70 Service and Installation Manual English
FONA X70 – X70 – Service Service and Installation Manual
FONA X70 Service and Installation Manual English Edition Version 140315 March 2014 2014 Code 69 500 70210 Manufactured by FONA S.r.l. Via Galilei 11 — 20090 Assago (MI) Italy Distributed by FONA Dental s.r.o. Stefanikova 7 SK-811 06 Bratislava, Slovakia www.fonadental.com
Table of Contents 1.
1.1 1.2 1.3 1.4 1.5 1.6 1.7 2.
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8
INTRODUCTION………………………………………… 4
PURPOSE……………………………………………….. 4 EQUIPMENT CLASSIFICATION ………………………… 4 APPLICABLE STANDARDS ……………………… …….. 4 ENVIRONMENTAL DATA ……………………………… 4 OBLIGATIONS OF THE INSTALLER ……………………. 4 WARNING ……………………………………………… 4 DEMONSTRATION …………………………………….. 4
TECHNICAL DATA ……………………………………… 5
2.1 2.2 2.3 2.4 2.5
SYSTEM SUPPLY ……………………………………….. 5 TUBE HOUSING ASSEMBLIES ………………………… 5 BEAM LIMITING DEVICE ……………………………… 5 AUTOSET TIMER ………………………………………. 5 MECHANICAL SUSPENSION SYSTEM ………………… 5
2.6
WEIGHTS ……………………………………….. …….. 5
6.
MAINTENANCE OF WALL ADAPTOR ………………. 20 MAINTENANCE OF SUPPORT ARM………………… 20 MAINTENANCE OF SCISSOR ARM …………………. 21 MAINTENANCE OF X-RAY HEAD…………………… 22 MAINTENANCE OF BEAM LIMITING DEVICE……… 22 MAINTENANCE OF TIMER ………………………….. 22 CHECKING FILAMENT PRE-HEATING TIME ………. 22 SERVICE FUNCTIONS………………………………… 23
MEASUREMENTS …………………………………….. 24
6.1 6.2 6.3 6.4 6.5
LINE VOLTAGE ………………………………………. 24 ANODE VOLTAGE – KVP …………………………… 24 ANODE CURRENT – MA ……………………………. 24 EXPOSURE TIME …………………………………….. 24 LEAKAGE RADIATION ……………………………….. 25
6.6 6.7
EARTH RESISTANCE- ………………………………… 25 EARTH LEAKAGE …………………………………….. 25
3. ………………………………………………………………….. 5
APPENDIX A SYSTEMS AND COMPONENTS ………… ………… 26
4.
APPENDIX B ICONS…………………………………………. 27 27
5.
ASSEMBLY AND INSTALLATION …………………… 6
4.1 4.2 4.3 4.4
WALL MOUNTED SYSTEMS ………………………….. 6 DIP SWITCH SETTING ……………………………….. 16 LAYOUT POWER BOARD TIMER ……………………. 17 MOBILE SYSTEMS ………………………. ………….. 18 18
4.5
MOUNTING THE TIMER …………………………….. 18
APPENDIX C EXPOSURE TABLE …………………………. 28 28 APPENDIX D ALARM CONDITIONS ……………………. 29 APPENDIX E IDENTIFICATION LABELS ………………… 30 APPENDIX F COOLING CURVES …………………………. 30
MAINTENANCE……………………………………….. 20
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The Control Panel 2
1
3
4 1
5 6
7 18 10
11
12
8 16
13
14
15
9
1 2
Device for emission of ionizing radiation on request Indication of system turned ON and ready
17
10 11
3
Irradiation
12
4
Alarm
13
5
Exposure time in s
14
6 7
Manual decrease of controlled technique factor Manual increase of controlled technique factor
15
Maxillary incisor Maxillary canine or premolar Maxillary molar Mandibular incisor Mandibular canine or premolar Mandibular molar
16
Bite-wing premolar
8
Patient build adult /large
17
Digital detector in use
9
Patient build child /small
18
Radiation exposure pushbutton
FILM SPEED INDEX 0.32 0.40 0.50 0.64 0.80 1.00 1.25 1.60 E type D type D type: Kodak Ultraspeed, Agfa Dentus M2 — E type: Kodak Ektaspeed Plus
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1. INTRODUCTION 1.1
Purpose
The FONA X70 X-ray Equipment is designed to fulfill the needs for high resolution intra-oral radiography in the general dental practice. The systems can be configured for wall, mobile solutions. The Operating Instructions and the Service and Installation Manuals supplied with the system are integral part of the product. The original language of the Operating Instructions is English.
1.2
Equipment Classification IEC: FONA X70 is a Class I, type B equipment FDA: FONA X70 is a Class II medical device equipment (21 CFR 872-1800).
1.3
Applicable Standards
The FONA X70 system configurations comply with the following standards. IEC 601-1 General requirements for safety IEC 601-1-2 Electromagnetic compatibility IEC 601-1-3 General requirements for radiation protection in diagnostic X-ray equipment Particular requirements for the safety of high volta ge generators of diagnostic IEC 601-2-7 X-ray generators Particular requirements for the safety of X-ray source assemblies and X-ray IEC 601-2-28 tube assemblies for medical diagnosis 21 CFR 1020.30 Diagnostic x-ray systems and their major components 21 CFR 1020.31 Radiographic equipment 93/42/EEC European Directive concerning medical devices (1993)
1.4
Environmental Data
Applicable ranges of temperature, humidity, and atmospheric pressure are reported here below both for operation and transport conditions. Ambient Transport & Storage Temperature from 10 to 40 °C from –20 to +50 °C Relative Humidity from 30 to 75% 10 to 90% Pressure from 700 to 1060 hPa from 500 to 1060 hPa
1.5
Obligations of the Installer
Obligations of the Installer are: To make sure that the line voltage specified by the Manufacturer of the equipment is available and within the specified range. For safety reasons verify that a proper switch is available to disconnect from line voltage supply when needed during installation. Install and test the equipment with due diligence according to the installation instructions from the Manufacturer. To provide the Operating Instructions to the User.
1.6
Warning
Use the system only after proper assembly and installation as per manufacturer’s instructions. X-ray equipment produce ionizing radiation that may be harmful if not properly controlled. It is therefore recommended that the equipment be operated by trained personnel onl y in accordance with existing law. Even if compliant to specifications of electromagnetic compatibility, it is recommended not to use the equipment in presence of external electromagnetic fields, such as th ose generated by cellular phones, which might interfere with the electronic circuits of the system.
1.7
Demonstration
In order to use of the system for demonstration purposes radiation emission has to be inhibited by disconnecting the supply cables to the X-ray head into the wall adaptor or into the timer. Cables to be disconnected are those leaving the connection block towards the X-ray head (“out”). Make sure that the disconnected cables are properly insulated to prevent undesired contacts with live points. This task has to be done by trained personnel only to avoid the risk of electrical shock.
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2.
TECHNICAL DATA
2.1
System Supply
Line Voltage Line Voltage Range Line Fuse Line Frequency Line resistance
2.2
Tube Housing Assemblies
Nominal Line Voltage Nominal Line Current Line Voltage Range Anode Voltage (peak tube potential) Anode Current (tube current) Nominal Power X-ray Insert Anode Focal Spot Inherent Filtration Duty Cycle Radiation Leakage
2.3
Precision Exposure factors Irradiation signal Hand-switch Overall size
Focus skin distance 21 cm (8.27”) Circular radiation field 6 cm (2.35”) diameter /Rectangular 3.2×4.2 cm (1.26”x1.65”) Maximum 10% eccentricity
110-120 for type 93 300 60200, 220-240 for type 93 300 60100 Exposure time in s, 18 steps from 0.06 s to 3.2 s (R10 scale) . Time in seconds is converted to number of mains pulses (20 ms at 50 Hz, 16.6 ms at 60 Hz). 0.06 0.12 0.25 0.50 1.00 2.00 0.08 0.16 0.32 0.64 1.25 2.50 0.10 0.20 0.40 0.80 1.60 3.20 ± 0.02 s or 5% (whichever the greater) Automatic setting through tooth type selection and patient build, for use with traditional film or digital sensor, or manual setting with plus and minus keys. Yellow light on hand-switch and on control panel plus acoustic buzzer Hand-switch with 3 m coiled cord, with remote mounting optional kit Width: 15 cm /6”, Height: 24 cm /9”½, Depth: 9 cm /3”½
Mechanical Suspension System
Wall Adaptor Arm Length Useful Reach Mobile Stand
2.6
6 A at 120 V for type 93 205 01300, 4 A at 230 V for type 93 205 01700 108 — 132 V for 93 205 01300, 207 – 253 V for 93 205 01700 70 kVp ± 8% at nominal line voltage 66 kVp ± 8% at nominal line voltage – 10% 74 kVp ± 8% at nominal line voltage+ 10% 7.0 mA ± 15% at nominal line voltage 5.3 mA ± 15% at nominal line voltage – 10% 8.3 mA ± 15% at nominal line voltage + 10% 0.4 kW at 70 kVp, 7 mA, 0.1 s 3 electrodes, grid control action models: OCX/70-G, RF8G070 Tungsten, angle 19° to the tube axis 0.8 (EN 60336:1995-04) > 2.5 mm Al (EN 60522: 1999) 1/30 < 0.1 mGy/h a 1 m (< 11.5 mR/h a 1 m)
AutoSet Timer
Supply Voltage Exposure factor
2.5
120 V for type 93 205 01300, 230 V for type 93 205 01700
Beam Limiting Device
Beam Limiting Device
2.4
115 V (from 99 V to 132 V in sub-ranges depending on THA mounted) 230 V (from 198 V to 264 V in sub-ranges depending on THA mounted) 108 — 132 V for type 93 205 01300, 207 — 253 V for type 93 205 01700 Slow Blow: 6.3 A at 115 V, 4 A at 230 V, second fuse for two phases or cord 50/60 Hz 1 Hz 0.4 Ohm at 115 V, 0.8 Ohm at 230 V Voltage regulation for maximum line current: 2.1% at 115 V, 1.4% V at 230 V
12 cm /4.7” width, 24 cm /9.4” height, 9 cm /3.5” depth Short (S): 30 cm /11.8”, Medium (M): 60 cm /23.6”, Long (L): 80 cm /31.5”, Extra Long (XL) 100 cm /39.4” Arm S: 138 cm /54.3”, M: 168 cm /66.1”, L: 188 cm /74”, XL: 208 cm / 81.9” Size 78 x 92 cm (30” ¾ x 36” ¼), Height: 186 cm /73” ¼” with scissor arm
Weights
Timer X-ray Head Circular BLD Rectangular BLD Scissor Arm
1.7 kg / 3.7 lb 6.6 kg / 14.5 lb 0.1 kg / 0.22 lb 0.2 kg / 0.44 lb 11.7 kg / 25.8 lb
Support Arm Wall Adaptor Mobile Stand
Arm S: 2.8 kg /6.2 lb , M: 4.0 kg /8.8 lb, L: 4.8 kg /10.6 lb, XL: 5.4 kg / 11,9 lb 1.3 kg / 2.9 lb 29.4 kg / 64.8 lb
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4. ASSEMBLY AND INSTALLATION 4.1
Wall Mounted Systems
4.1.1
Installation Options
The timer box can be mounted together with the X-ray head on the right of the wall adaptor or can be placed remote either inside or outside the examination room. The release hand-switch can be directly connected to the timer box or placed remote making u se of specific mounting kit including 10 m cable. A door contact and /or a second exposure button can be added via the internal socket on the timer board.
4.1.2
Unpacking
Unpack the components of the system and check the fol lowing: A Each item is in good conditions and was not damaged during transportation. B All the items for the desired system configuration are available. C The line voltage on the labels of timer and X-ray head are corresponding to the local line voltage.
4.1.3
T1
T3
T2
Structural Requirements
The wall adaptor has to be mounted in a convenient position on left or right side of the chair or on back wall (head of the patient). The maximum useful reach is of 208 cm (81.9” ) from the wall when using an 100 cm (39.4” ) support arm. The wall adaptor can be mounted with 2, 4, or 6 bolts, depending on wall quality. A Two bolts only (top and bottom central holes – T2, B2) are used when there is a solid slim column (e.g. iron mounting) with weak sides (e.g. wooden wall). Considering the requested safety factor, the top bolt has to withstand a load of 8878 N, comprehensive of a safety factor, i.e. about 2013 lbs or 906 kg. Proper screw to be selected for a solid B3 B1 B2 connection to the wall. Classes ISO 8.8 (M 8, M 8×1, M 8×1.25) or SAE Grade 5 (5/16” 18UNC, 5/16” 24 UNF) are recommended. B Four bolts, two on top sides (T1, T3) and two on bottom sides (B1, B3) is the regular mounting for solid (concrete) wall, but also on large metal plate. Considering the requested safety factor, each bolt at top has to withstand a load of 4439 N, comprehensive of a safety factor, i.e. about 1007 lbs or 453 kg. Proper expansion screw to be selected for a solid conn ection to the concrete wall; the permissible load of each screw has to be greater than 308 lbs (about 140 kg). On solid concrete use heavy duty metal anchors. On hollow bricks use injection chemical fixing. C Six bolts, three on top (T1, T2, T3) and three at bottom (B1, B2, B3) are required when the wall is not solid enough and the load has to be distributed on more points. Considering the r equested safety factor, each bolt at top has to withstand a load of 2959 N, comprehensive of a safety factor, i.e. about 671 lbs or 302 kg. In case the wall is not in condition to withstand the indicated l oad, corrective actions can be evaluated by adoption of reinforcing plates: D Large plate to fit vertical supports at 16” distance, with 4 mounting holes and one cable opening for the wall mount in the middle. E In case of a thin (wooden) wall not solid enough, the use of a steel counter plate 2 mm thick can be the solution. Make sure that the wall is solid enough to carry the load. F The use of two reinforcing steel plates of about 4 times the surface of the wall adaptor, one by each side of the wall, can help when a single plate l ooks not adequate; additional bolts have to be used t o hold together the two plates. Make sure that the wall is solid enough to carry the load.
Diameter M 8X1.25 M 8X1 5/16” – 18 UNC 5/16 –24 UNF
Recommended Bolts Class ISO 8.8 ISO 8.8 SAE- Grade 5 SAE- Grade 5
Core Section mm 36.6 39.2 33.8 37.41
INSUFFICIENT WALL OR HARDWARE STRENGHT MAY CAUSE THE WALL ADAPTOR TO PULL OUT FROM THE WALL AND THE FULL SYSTEM TO FALL ON TO THE PATIENT OR THE OPERATOR CAUSING INJURIES.
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FONA X70 – Service and Installation Manual 4.1.4
Electrical Requirements
The power line cable must be connected to the input terminals (IN) of the timer to supply the timer itself and to make available power for the X-ray head at the output terminals (OUT), upon request by the operator (via the hand switch). Power to the X-ray head is thus controlled by the timer (acting as a SWITCH).
INPUT POWER LINE
X-RAY HEAD
SWITCH IN
OUT WALL ADAPTOR
ELECTRONIC TIMER
The cables (2 poles plus ground) to connect the power line to the timer and the timer to the wall adaptor are not provided. Cables with large section conductors have minimum electrical resistance and voltage drop.
Wire Type AWG 14 AWG 12
Cross Section Area 2.08 mm2 3.31 mm2
Resistance/m 0.00829 Ohm/m 0.00521 Ohm/m
m/0.05 Ohm 6.0 m 9.6 m
The resistance between the ground provision in t he connecting block of the timer and the metal body of the tube housing assembly has not to exceed 0.1 Ohm. Proper section of the yellow green wire to be used in case remote mounting of the timer. The wall adaptor is provided with a common bolt for bonding and grounding blocked in place with a nut which has not to be removed. The grounding conductors to be connected as indicated below. First the conductor to ground provision in the connecting block of the timer (flat washer, ground provision, flat washer, lock-washer, nut). Second the bonding conductor of support arm plus, in case, the one of the cable in the scissor arm (flat washer, bonding conductors, flat washer, lock-washer, nut).
LOCK-WASHER FLAT WASHER BONDING CONDUCTOR OF SCISSOR ARM (IN CASE)
COMMON BOLT BONDING CONDUCTOR OF SUPPORT ARM GROUND PROVISION TO TIMER
NUT
NUT
FLAT WASHER LOCK-WASHER FLAT WASHER FLAT WASHER
BLOCKING NUT DO NOT REMOVE
METAL BODY OF WALL SUPPORT
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FONA X70 – Service and Installation Manual 4.1.5
Mounting and Connecting Sequence
Step 1
Mount the Wall Adaptor
Step 7
Connect the Hand-Switch
Step 2
Mount the Timer
Step 8
Optional Remote Hand-Switch
Step 3
Mount the Support Arm
Step 9
Mount and connect X-ray head
Step 4
Mount the Scissor Arm
Step 10
Mount the collimator
Step 5
Connect the Wall Adaptor
Step 11
Final Tuning and Set-Up
Step 6
Connect the Timer
4.1.6 A B
C D E F G
Mounting the Wall Adaptor
Take away the plastic cover removing the screws under the logo label. Use the Wall Adaptor plate or a template to mark the holes on the wall. Please note that the timer can be mounted close to the Wall Adaptor on the right side or in a remote position. Cabling should have been laid out accordingly. Make the holes in the wall according to the applicable type of mounting with two, four bolts, or six bolts, with or without reinforcing plate. Slide the logo-strip out from the plastic cover to access the screws and remove it from the metal frame. Mount the metal frame on the wall using proper heavy-duty metal anchors and make sure that the power cable enters from behind. Secure it to the wall ensuring it is leveled. Improper leveling might cause the arm to move and swing out of position. Perform wire connection and final set-up complying with recommended sequence of actions reported in the following.
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FONA X70 – Service and Installation Manual 4.1.7
Mounting the Timer
Use the mounting plate or the template to mark the holes on the wall. B Remove the plastic cover after having taken away the blocking screws behind the logo strip. Pay attention when disconnecting the flat cable of the control panel from the control board. C Drill the four holes in the wall and secure the timer making sure it is leveled. Cabling should have been laid out in accordance to mounting requirements. D Perform wire connection and final set-up complying with recommended sequence of actions reported in the following.
A
4.1.8
Mounting the Support Arm
Unpack the support arm and check for completeness of parts. Do not remove the rope to pull the cable of the Scissor Arm to the Wall Adaptor through the Support Arm. C Push back the cylinder of the side friction not to interfere, lightly grease the shaft of the extension arm and insert it into the wall adaptor. D Mount the rotation end-stop spacer and close the side friction without tightening.
A B
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FONA X70 – Service and Installation Manual 4.1.9
Mounting the Scissor Arm
WARNING. THE SPRINGS IN THE SCISSOR ARM MAY CAUSE INJURY TO THE INSTALLER AS WELL AS DAMAGE TO THE ARM ITSELF IF NOT HANDLED PROPERLY. DO NOT REMOVE THE BINDING STRING UNTIL WHEN NECESSARY
Light grease the shaft at the base of the arm and make sure the ring spacer is in place; push back the cylinder of the friction into the support arm not to interfere during the insertion of the shaft. B Secure the trailing rope to the end of the electrical cable of the Scissor Arm. C Pull the other end of the trailing rope to drive the electrical cable of the Scissor Arm through the Support Arm out into the Wall Adaptor. D Hold the opening section of the Scissor Arm, carefully remove the safety string and allow the arm to open slowly, away from people. E Perform final set-up complying with recommended sequence of actions reported in the following.
A
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FONA X70 – Service and Installation Manual 4.1.10 Connecting the Wall Adaptor with Timer at side
MAINS LINE INPUT TO TIMER YELLOW-GREEN BONDING CONDUCTOR OF SUPPORT ARM
SUPPLY CABLE OUTPUT TO TUBE HEAD
SUPPLY CABLE FROM TIMER TO TUBE HEAD
YELLOW-GREEN GROUND PROVISION TO TIMER YELLOW-GREEN GROUND PROVISION FROM MAINS A B C
YELLOW-GREEN GROUND PROVISION ON TIMER
Pass the conductor of the grounding provision (already connected to the common bolt) into the timer for connection to the central ground point in the connecting block (protective earthing). Connect the grounding provision of the extension arm to the common bolt on the wall plate (flat washer, ground provision, lock-washer, nut). Pass through the supply cable of the arm into the timer for connection to the OUT positions (supply cable output to X-ray head).
4.1.11 Connecting the Wall Adaptor with Timer remote A
In case the connection to the mains is done starting from the wall adaptor a 5 position connection block has to be mounted. This approach is r ecommended allowing for a lower ground resistance. a The ground wire of the mains has to be connected i n first position on the common bolt and blocked with a nut. b The mains line goes to the remote timer and back through the connection bloc k to the X-ray head. c The other grounding provisions for support arm and of cable returning from the timer to be connected to the common bolt and blocked with a second nut. d The ground resistance to consider is actually the one of the cable in the scissor arm.
In case the connection to the mains is done through the timer box, the ground resistance to consider includes the wire from the timer to the wall adaptor. a Prepare the terminations of the cable for remote connection of timer with tips to fit the connecting blocks in timer and connecting blocks plus the common bolt for grounding in wall adaptor. Make sure the copper section of the yellow green wire i s large enough (see section 0, b Electrical Requirements, at page 7). B
YELLOW-GREEN TO COMMON BOLT ON WALL ADAPTOR WALL ADAPTOR SIDE
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FONA X70 – Service and Installation Manual C
Remove from the common bolt for bonding and grounding on the wall adaptor the existing cable for ground provision.
BOLT FOR BONDING AND GROUNDING
SUPPLY CABLE FROM REMOTE TIMER TO TUBE HEAD
SUPPLY CABLE TO TUBE HEAD YELLOW-GREEN BONDING CONDUCTOR SUPPORT ARM
YELLOW-GREEN GROUND PROVISION FROM TO TIMER
YELLOW-GREEN BONDING CONDUCTOR SCISSOR ARM
Connect the cable for remote connection of the timer by placing the ground wire as first conductor on the common bolt for bonding and grounding; block with washers and nut. E Place the phase and neutral wires to the connecting block. F Connect to the common bolt for bonding and grounding the bonding conductor of the extension arm and the one of the cable of the arm. G Connect the phase and neutral conductors of the supply cable in the arm to the connecting block. See section 0, H Electrical Requirements, at page 7 to determine cable length and maximum distance. D
CONNECTIONS IN THE REMOTE TIMER
CONNECTING BLOCK IN THE TIMER MAINS SUPPLY INPUT TO TIMER SUPPLY CABLE FROM REMOTE TIMER TO TUBE HEAD
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FONA X70 – Service and Installation Manual 4.1.12 Connecting the Timer
FUSE F4 NEUTRAL
GROUND
ZERO OHM RESITOR
LIVE
FUSE F2
HAND-SWITCH CONNECTION JUMPERS HAND-SWITCH SOCKET TST2
IN HAND-SWITCH SOCKET TST1
OUT
FUSE F1
Turn-off the voltage supply line. Connect the three wires from the voltage supply to the terminal block (IN on the left) but do not connect any outgoing wire (OUT on the right) to Wall Adaptor. B Make sure that the “live” conductor is the “hot” one: a Connect an AC voltmeter or a test light between the block terminal “live in” and “ground”. b Turn line voltage supply “ON”. If full line voltage is measured (test lamp lights) the wiring is correct. If not turn line voltage supply “OFF”, reverse “live in” and “neutral in” wires and repeat the measurement; eventually the full line voltage should be r ead between “line” and “ground” (test lamp lights). c Make sure no voltage is read between “neutral in” and “ground”; if not check line voltage distribution. C Test the timer for full functionality keeping the output cables disconnected not to supply the load. D Connect the load. a Turn OFF the line voltage supply line, b Connect the three wires of additional cable outgoing to the Wall Adaptor, Arm, Tube Housing Assembly. Live and neutral wires to the arm (X-ray head) can be interchanged.
A
Ref. F1 F2 F3 F4
Fuses of FONA X70 Timer 115 V 6.3 AT 5×20 6.3 AT 5×20 315 mAT 5×20 80 mAT 5×20
230 V 4 AT 5×20 4 AT 5×20 315 mAT 5×20 50 mAT 5×20
4.1.13 Connecting the Hand-Switch A
The hand-switch is provided with a 3 m coiled cord to be plugged one side in the hand-switch, the other side in the lower left corner of the timer’s board, either externally (connector TST1) or internally to the timer (connector TST2). Internal connection is for remote hand-switch or for additional control safety switches.
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FONA X70 – Service and Installation Manual B
Jumpers are available to activate properly the hand-switch connection: a Position TST1 to enable external socketTST1, b Position TST2 to enable the internal socket TST2, c Position TST1/2 f to enable the internal and the external sockets.
4.1.14 Optional Remote Hand-Switch The hand-switch can be remotely mounted by making use of the optional kit made of a remote box (wall holder) and connection cable 10 m long. The connection of the wires is here indicated. The wires of the switch are number 3 and 4 (those in the middle of the connector).
4.1.15 Mounting and Connecting the X-ray Head A
HANDGRIP PIPE B
C
D
E
RETAINING FORK F
Remove the handgrip pipe from the arm and place it onto the tube-head shaft of the coupling yoke. Lubricate the shaft, insert it into the arm passing the cables into the coupling yoke, then hold it in place with the retaining fork. Attach the connectors of the supply and grounding wires and push them into the side opening of the coupling yoke. Pull down the O-ring and push-up the handgrip pipe, then fix it in place with the screw at bottom. Verify smooth movement of the tube head around its vertical and horizontal axis. Tune side friction if necessary referring to section 5.4, Maintenance of X-ray Head, at page 22 for details. Mount the cover on the yoke opening eventually.
COUPLING YOKE
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FONA X70 – Service and Installation Manual 4.1.16 Beam Limiting Device A
Mount the beam limiting device on the tube- head and lock it close with a clock-wise rotation .
4.1.17 Final Tuning and Set-Up A
Remove the line voltage fuse(s) from the timer (Fuse 1 and Fuse 2).
B
Tune friction screw in Wall Adaptor for rotation of Support Arm (see section 5.1, Maintenance of Wall Adaptor at page 20 for details).
C
Tune friction screw in Support Arm for rotation of Scissor Arm around it vertical axis (see section 5.2, Maintenance of Support Arm at page 20).
D
The friction points in the scissor arm and those for the rotation of the X-ray head around its horizontal axis are tuned in factory. Should you need to repeat the procedures refer to sections 5.3, Maintenance of Scissor Arm, at page 21 and 5.4, Maintenance of X-ray Head, at page 22, respectively.
E
Make sure the Timer switch is in the “OFF” position.
F
Set the dip switches SW2 as indicated in the following to define: a Enable/disable function for correction of exposure in presence of line voltage fluctuations. b The nominal line voltage of the X-ray head (see label). c Set the pre-heating time according to type of X-ray insert used in the X-ray head assembly; the measured value is marked on the X-ray head.
G
Put back the line voltage fuse(s).
H
Put back all plastic covers and logo strips.
I
Connect the system to the line voltage by switching the general line voltage switch on and/or plug the power cord into the wall socket.
J
Switch the timer “ON”.
The system is now ready for functional checks.
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FONA X70 – Service and Installation Manual 4.2
Dip Switch Setting
DIP 4 NOT USED
DIP 1 TECHNIQUE FACTOR CORRECTION
DIPS 2-3 TUBE HEAD
DIPS 5-6-7 PRE HEATING TIME
DIP 1 Technique Factor Correction
DIPS 5 – 6 – 7 Pre Heating Time
Disabled
100 ms
Enabled
120 ms
DIPS 2- 3 Tube Head Type
140 ms
110 or 220 VAC
160 ms
115 or 230 VAC
180 ms
120 or 240 VAC
200 ms
127 or 250 VAC
220 ms DIP 4 Not used
DIP 8 NOT USED
240 ms DIP 8 Not used
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FONA X70 – Service and Installation Manual 4.3
Layout Power Board Timer
SET-UP MICROSWITCHES
POWER SUPPLY 5 V LED
KEYBOARD CONNECTOR BACK UP TIMER TEST POINT & LED
MICROPROCESSOR WATCH DOG LED POWER SUPPLY 24 V LED
FUSE 4 T50mA @230V T80mA @115V
JUMPER FUSE 2
5VA TRANSFORMER PRIMARY 115/230 V SECONDARY 18 V
FUSE 3 T 315 mA
HANDSWITCH JUMPERS
FUSE 1 & FUSE 2 T4A @230V T6.3A @115V
INPUT MAINS LINE NEUTRAL & LIVE
OUTPUT LINE TO TUBEHEAD
MAINS SWITCH HANDSWITCH SOCKETS
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FONA X70 – Service and Installation Manual 4.4 4.4.1
Mobile Systems Unpacking
Unpack the components of the system and check the following: A Each item is in good conditions and was not damaged during transportation. B All the items for the desired system configuration are available. C The line voltage on the labels of timer and X-ray head correspond to the existing local line voltage.
4.4.2
Room Preparation
Make sure that a wall socket is available close to the dental chair in reach of the mobile X ray equipment. Such a socket has to be provided with connection to the protective grounding. The line voltage cable can come without plug to be added according to the local standard.
4.4.3
Mounting and Connecting Sequence
Step 1
Assemble the Mobile Stand
Step 2
Mount the Scissor Arm
Step 3
Mount the Scissor Arm
Step 4
Mount the Timer
Step 5
Connect the Line Voltage Cable
Step 6
Connect the Timer
Step 7
Activate second Fuse
Step 8
Mount and connect X-ray head
Step 9
Mount the collimator
Step 10
Final Tuning and Set-Up
4.4.4
Assembling the Mobile Stand
A Mount the legs below the central base. B Mount rear wheels and front wheels with brakes. C Attach the pole with timer plate. D Complete the stand with cable holder and handles
4.4.5 A B
4.5
Mounting the Arm
Loosen the friction and push back the cylinder of the same not to interfere during shaft insertion. Insert the arm. Refer to section 4.1.9 at page 10 for details.
Mounting the Timer
The timer is blocked in place with four bolts.
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FONA X70 – Service and Installation Manual 4.5.1
Connecting the Line voltage cable
The line voltage cable for the mobile has to be completed with local plug. B The power supply cord bonding conductor has to be blocked (first) to the common bolt for bonding and grounding using lock-washer and nut. C The grounding wire for the timer is then placed on the same common bolt and blocked (second) with lock- washer and nut. D Connect the grounding wire for the timer to the ground provision on the terminal block of the timer and the two line wires of the power cord to the input points of the terminal block of the timer.
A
4.5.2
Connecting the Timer
For the connection of the output cable to the timer please refer to section 4.1.11 at page 13.
4.5.3
Activation of Fuse 2
Units provided with supply cord and plug must be equipped with fuses on both line phases. The activation on the second fuse is done by cutting the Jumper Fuse 2 (zero Ohm resistor) close to Fuse F2. See position on layout in section 0 at page 17.
4.5.4
POWER SUPPLY CORD BONDING CONDUCTOR
Mounting and Connecting the X-ray Head
Refer to section 4.1.15 at page 14.
4.5.5
Mounting the Beam Limiting Device
Refer to section 0 at page 14.
4.5.6
Final Tuning and Set-Up
Refer to section 4.1.17 at page 15.
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FONA X70 – Service and Installation Manual
5. MAINTENANCE Here in the following the list of recommended maintenance actions to keep the FONA X70 system in compliance with the Performance Standard. It is the responsibility of the User to maintain the equipment in compliance with the standard. Failure of the User to properly maintain the equipment may relie ve the Manufacturer, or its Agent, from responsibility for any injury, damage or non compliance which may result. Maintenance for the FONA X70 system to be done regularly by a service technician at least once every 24 months, with regular checks performed by the operato r every year. Any defect or malfunction should be corrected immediately by qualified personnel with adequate training. WARNING.
Any defective item affecting a safe use must be repaired or replaced Only original certified components and spare parts mus t be used for repairs or replacements. Correction of damages to the identification labels to be handled with the Manufacturer. Any defect or non-compliance must be reported promptly to the Manufacturer or to its Local Agent. Always disconnect the system from the line voltage supply using the general line voltage switch for the room where the equipment is located before performing any maintenance activity Avoid using liquid or spray detergents which may enter into the equipment and cause corrosion. Avoid the use of solvents or corrosive detergents which can damage painted surfaces and plastic covers.
5.1
Maintenance of Wall Adaptor
POSITION OF 21 DISK SPRINGS IN FRICTION SCREW 7 GROUPS OF 3
FRICTION SCREW
Remove the cover and verify that the mounting is closely connected to the wall and stays firm and steady during the movements of the system. B Verify for proper connection of grounding wires to the common bolt. C Check friction during rotation of Extension Arm and adjust if needed. D Verify that the technical label with identification data outside the plastic cover at bottom is in place and is readable.
A
5.2
BOLT FOR BONDING AND GROUNDING
Maintenance of Support Arm
POSITION OF 15 DISK SPRINGS IN FRICTION SCREW 5 GROUPS OF 3 FRICTION SCREW Slide partially out the extension arm from wall mount, inspect for wear of the joint and lubricate for smooth rotation. B Check friction during rotation of Arm and adjust relevant screw if needed. C Verify that the technical label with identification data is in place and is readable.
A
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FONA X70 – Service and Installation Manual 5.3
Maintenance of Scissor Arm
FRICTION POINT 3
SPRING TUNING POINT
FRICTION POINT 2 SPRING TUNING POINT
A B
LABEL
FRICTION POINT 1
C
D E F G
FRICTION POINT 4
Balance the arms (2 sections) and tune frictions (4 points) if needed in normal conditions with X-ray head mounted. To balance the arm, for each arm’s section: a Remove plastic covers at the joints. b Reduce the friction at the 2 friction points by loosening the socket set screw (allen) into the female friction pin which is blocking male and female pins together, then loosen them to reduce friction. c WARNING. Trying to loosen the friction pins without having loosen the socket set screw might lead to breaking the friction pins. d Tune the springs using an allen key for even balancing with arm section in intermediate position. UNLOCK e Tighten the two friction pins for little SOCKET SET SCREW resistance to the movement, and WITH ALLEN KEY eventually tighten the socket set screw (allen) into the female friction pin to block male and female friction pins together.
ALLEN KEY
Specifically for the arm, at least ALLEN KEY every 24 months in case of normal use or after every 5000 cycles performed, have the service technician inspect for wear of pins and levers. a Remove plastic covers. b Check for wearing out of pin and levers, starting from the joint at the base of the arm. c Make sure no part is loose and no vibrations are occurring during movements. d Apply silicon spray lubricant if needed. e Replace the worn out parts or the arm itself if they appear damaged. To replace defective pins or levers a have the X-ray head disconnected with arm fully open to avoid injuries for sudden opening. b Loosen completely the two springs of the arm before extracting pins or removing levers. Mount back the X-ray head if removed and secure it with the retaining fork. Slide partially out the Scissor Arm from the Support Arm, inspect for wear of the vertical joint and lubricate for smooth rotation. Verify that the label with identification data is in place and is readable.
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FONA X70 – Service and Installation Manual 5.4
Maintenance of X-ray Head
HOLDING SCREW BLOCKED
POSITION OF 8 DISK SPRINGS IN FRICTION SCREW 4 GROUPS OF 2 A B C
D E F G
Inspect for damage/wear to the X-ray tube-head and support system. Inspect for oil leakage. Replace tube-head if FRICTION necessary. SCREWS Check for position stability. If necessary remove the cap on the yoke side, tune the three friction screws (with disk springs) to be moderately tight for smooth rotation. The fourth one without disk springs must be blocked in place Check that electrical cables are correctly twisted and not damaged or worn down. Verify that the technical label with identification data is in place and is readable. Dismount the tube-head from the arm and lubricate the pin for smooth rotation. Warning: remove the tube-head with the arm completely open to avoid t he risk of injuries. Check the retaining clip and replace if worn down. Do not mount the tube-head until all checks of the suspension system are completed.
5.5
Maintenance of Beam Limiting Device
A Verify that the collimator is properly mounted and firmly closed. B Verify that the internal cone is not damaged. Replace the collimator if necessary. C Verify that the technical label with identification data is in place and is readable.
5.6
Maintenance of Timer
Inspect the panel for damages on the surface. Inspect the cable of the exposure switch for wear. Check that all lights (except the yellow one) are working when the system is switched on. Perform a functional check with verification of a) setting of dip switches, b) yellow light, c) buzzer, d) alarm A07 for “Exposure push button pressed at power on”, e) alarm A08 for “Exposure stopped by the operator”. E Verify that the fuses mounted comply with those indicated on the label and listed below. F Verify that the technical label with identification data is in place and is readable.
A B C D
Ref. F1 F2 F3 F4 5.7
Fuses of FONA X70 Timer 115 V 6.3 AT 5×20 6.3 AT 5×20 315 mAT 5×20 80 mAT 5×20
230 V 4 AT 5×20 4 AT 5×20 315 mAT 5×20 50 mAT 5×20
Checking Filament Pre-Heating Time
During the life of the system the wearing down of the filament may result in a different pre-heating time (PHT). The value set at installation needs therefore t o be verified and in case corrected. A At a fixed distance measure the X-ray dose for exposure of 2.0 s (nominal irradiation of 100 pulses at 50 Hz, 120 at 60 Hz). B At same distance measure the dose for exposure of 0.2 s (nominal irradiation of 10 pulses at 50 Hz, 12 at 60 Hz). C If dose at 0.2 s is 1/10 of dose at 2 s, the value set for PHT is fine. D If dose at 0.2 s is lower than 1/10 of the dose at 2 s, PHT has to be increased. Proceed at steps of 20 ms until fine. E If dose at 0.2 s is higher than 1/10 of the dose at 2 s, PHT has to be reduced. Proceed at st eps of 20 ms until fine.
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FONA X70 – Service and Installation Manual 5.8 A
Service Functions Digital Volt Meter. This function allows the user to display the line voltage level. a
Enter this function by switching the system “on” while pressing at the same time the , the
b
B
, and the
keys.
Exit by switching the system off.
Test of Control Panel. This function is intended to test lights, buttons, and segments of numerical display on the control panel. a Enter this function by switching the system “ON” while pressing at the same time the , the b
, and the adult
keys.
By pressing the or keys all segments of the numerical display are scanned.
By pressing the X-ray pushbutton the “rAY” message is displayed. d By pressing each button on the panel, the corresponding lamp is turned “ON”; a second pressure would turn it “OFF”. e At the last button pressed the system exit this function. c
f
WARNING: Do not press the X-ray pushbutton as last button twice; the second time the timer becomes active and radiation could be emitted.
C
FIRMWARE VERSION. This function returns the code of the version of firmware loaded. a
Enter this function by switching the system “ON” while pressing at the same time the
b
, the
, and the adult
child
keys. Exit by switching the system OFF.
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FONA X70 – Service and Installation Manual
6. MEASUREMENTS All measurements to be done with the equipment supplied at nominal line voltage with specified line resistance. The tolerances on the measured values have to take into account the precision of each measurement instrument. Measurements have to be done by trained personnel only to avoid the risk of electrical shock.
6.1
Line Voltage
The Line voltage can be measured using a Volt Meter f or Alternate Current within the proper range. A service function can be activated on the timer to dis play the current line voltage in V and frequency in Hz (see section 5.8 of this Manual).
6.2
Anode Voltage – KVp
The kVp level is the actual peak value of the Anode volt age which stabilizes once the preheating time of the filament has elapsed (in about 0.2 s) and the high voltage transformer is actually loaded. The kVp level can be measured with a non-invasive kVp meter placed in front o f the BLD following the instructions in t he user manual of the instrument. A correct measure can be done with an exposure time of 500 ms or more having introduced a delay of the reading instrument of about 300 ms to allow the voltage level to stabilize after the pre-heating time has elapsed.
6.3
Anode Current – mA
WARNING. To prevent high voltage shock make sure the system is disconnected from the power supply when connections to the measurement points are performed. Electric discharge might occur in case of improper operation. The Anode current in mA is the actual average value of the tube current which raises when the filament has warmed -up, after the pre-heating time has elapsed. Remove the back cover of the tube-head, disconnect the jumper A1-A2 and replace it with a resistor of 1000 Ohm. The anode current can be read with a DC voltmeter connected to points A1 and A2, with the 1 V corresponding to 1 mA. After the measurement disconnect the 1000 Ohm resistor and put back the jumper.
6.4
A1
A2
Exposure Time
Here below the timing indications in s and in line pulses at 50 and 60 Hz as well as mAs at 7 mA. Pulses 50 Pulses 60 Pulses @50 Pulses @60 s mAs s mAs Hz Hz Hz Hz 0,06 0.42 3 4 0,50 3.50 25 30 0,08 0.56 4 5 0,64 4.40 32 38 0,10 0.70 5 6 0,80 5.60 40 48 0,12 0.88 6 7 1,00 7.00 50 60 0,16 1.12 8 10 1,25 8.75 62 75 0,20 1.40 10 12 1,60 11.2 80 96 0,25 1.75 12 15 2,00 14.0 100 120 0,32 2.24 16 19 2,50 17.5 125 150 0,40 2.80 20 24 3,20 22.4 160 192 The actual exposure (loading) time is “determined as the time interval between the instant when the tube current first rises above the 25% of its maximum value and the instant when it finally falls below the same value”. In order to assure the requested exposure time (irradi ation), the pre-heating time of the insert used, which has been set-up at installation, is taken into co nsideration. The actual switch-on time (SOT) of the X-ray head assembly is therefore the sum of the filament pre -heating time (PHT) and of the requested exposure time (RET). SOT = PHT + RET The measurement of the exposure time can be done wi th kVp & Time meters with the ability to t rigger at 75% of maximum kV level. Exposure time can also be measured after having connected a resistor of 1000 Ohm between points A1 and A2 on the small circuit board on the back of t he X-ray head, by monitoring the voltage across it (tube current) with an oscilloscope, and counting the number of pulses in the time interval.
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FONA X70 – Service and Installation Manual When the function to correct the effects of line fluctuations on the emitted X-ray dose is activated, the exposure time is corrected in order to assure dose consistency. When the actual line voltage is lower than the nominal line voltage, the actual exposure time is increased. Conversely, when the actual line voltage is higher than the nominal line voltage, the actual exposure time is decreased. Do disable this correction function (dip switch number 1 of SW2 moved to OFF position) to verify exposure time accuracy.
6.5
Leakage Radiation
The value of leakage radiation of the X-ray tube assembly is measured at 1 m distance taking into account the energy provided in 1 hour. In case the measurement is performed at a distance different from 1 m, the value has to be properly corrected. The applicable technique factors for FONA X70 are of 70 kV and 7 mA. The point of maximum leakage has to be considered, excluding the direction of t he primary beam. The duty cycle factor has also to be taken into account for the computation of the actual dose rate. In case for example a measure is done at 50 cm distance from the source with an exposure of 1 s, the following computations have to be performed: A duty cycle of 1/30 means maximum of 1 s exposure every 30 s, i.e. 120 s per hour. Dose at 100 cm is computed taking into account the inverse square law, i.e. at twice the distance the dose intensity is reduced to one quarter. D1h100cm = D1s50cm * 120 * (50/100)2 = D1s50cm * 30 where: D1s50cm is the dose measured at 50 cm with 1 s exposure and D1h100cm is the dose computed at 1 m distance for the energy of 1 hour.
6.6
Earth Resistance-
The measurement of the earth resistance to be done after having disconnected the system for the power supply line. Using a voltage generator of not more than 6 V, 50/60 Hz, a current of 25 A is applied from 5 s to 10 s through the earth terminal in the connecting block of the timer to any metal part which can be in touch to the patient/operator (applied part). The voltage drop is then measured and the eart h resistance computed. The system complies for values up to 0,1 (extended to 0,2 in case of mobile system).
6.7
Earth Leakage
Connect the Timer to the measuring circuit as shown in the figure (R1=10 k 5%, R2=1 k 1%, C1=0,015 F 5%) A Set the input supply voltage (Vp) equal to 110% of the nominal supply voltage. B Connect a voltmeter (Vx with 1 MOhm input impedance) to the indicated points C Switch the Timer “ON” D Make two measures in Normal Conditions (NC with S1 “ON”) S5 “ON”: live and neutral conductors in normal condition. S5 “OFF”: swap of live and neutral conductors. E Make two measures in Single Fault Condition (SFC with S1 “OFF”). S5 “ON”: live and neutral conductors in normal condition. S5 “OFF”: swap of live and neutral conductors. Please note that 1V equals to 1mA. Values of leakage currents have to be within the limits of table below.
Limit of earth leakage current for X-ray equipment Type of connection Normal Condition Single Fault Condition to line voltage supply (S1 “ON”) (S1 “OFF”). Permanent 5 mA 10 mA With power cord 2.5 mA 5 mA
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FONA X70 – Service and Installation Manual
Appendix A Systems and Components FONA X70 Systems at 230 V Description
Code
97 576 62320 97 576 62620 97 576 62820 97 576 62120 97 576 67820
Code
Wall Syst. Arm S 30 cm 230V Wall Syst. Arm M 60 cm 230V Wall Syst. Arm L 80 cm 230V Wall Syst. Arm L 100 cm 230V Mobile System 230V
FONA X70 Systems at 120 V Description
97 526 62320 97 526 62620 97 526 62820 97 526 62120 97 526 67830
Wall Syst. Arm S 30 cm 120V Wall Syst. Arm M 60 cm 120V Wall Syst. Arm L 80 cm 120V Wall Syst. Arm L 100 cm 120V Mobile System 120V UL/CSA
C C
G
B
F
A G H I F
L
E
D
ID A B C D E
Description Wall adaptor Support arm S 30 cm Support arm M 60 cm Support arm L 80 cm Support arm L 100 cm Scissor arm Mobile stand Mobile stand UL/CSA Wall plate 16”
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J
K
Code
ID
93 105 11000 93 150 17100 93 150 17200 93 150 17300 93 150 17400 93 150 12010 93 150 20080 93 150 20090 86 100 21500
F G H I J K L
Description X-ray head 7 mA 120 V X-ray head 7 mA 230 V AutoSet Timer 110-120 V AutoSet Timer 220-240 V 6 cm circular field BLD 3×4 cm X-ray field BLD Coiled cable Hand-switch W/O cable Kit remote hand-switch
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Code 93 205 01300 93 205 01700 93 305 60200 93 305 60100 91 300 00020 91 300 00040 76 190 25580 76 190 25596 93 300 02000
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Appendix B Icons IEC Type B Equipment
Compliance to European Community Requirements
X-ray On Irradiation
Compliance to Canadian and US Standards
Examine Annexed Documentation
Line voltage supply On — System Ready
Increase Exposure Time (one step)
Off (Disconnected from Line voltage Supply)
Decrease Exposure Time (one step)
On (Connected to Line voltage Supply)
Child – Small Patient
~
Adult – Large patient
Fuse
Upper Incisor
Protective Earth
Upper Canine/Premolar
N
Neutral Point (for equipment permanent connected to line)
Upper Molar
L
Live Point (for equipment permanent connected to line)
Lower Incisor
Lower Canine/Premolar
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Alternate Current
Inherent Filtration
Focal Spot
Lower Molar
Fragile, Handle With Care
Bite Wing — Interproximal
Fear of Humidity
Digital Receptor
Up Do Not Overturn
Radiography Push Button
Stacking Limit
Ionizing Radiation
Separate Collection, Do Not Dispose
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Appendix C Exposure Table FONA X70 — 70 kVp, 7 mA — Exposure Times in s
m l i F D
e c n a t s i D m c m 1 l i 2 F s u c o F
Lower Molar Lower Premolar /Canine Lower Incisor
e c n a t s i D m c m l 1 i 3 F s u c o F
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m l i F D
l a t i g i D
m l i F E
Small Patient
l a t i g i D
m l i F E
m l i F D
l a t i g i D
m l i F E
Large Patient
3,20
2,50
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
2,50
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
1,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
Bite Wing
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
Upper Incisor
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
0,08
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
0,08
0,06
m l i F D m l i F D
m l i F D
l a t i g i D
m l i F E
Small Patient
l a t i g i D
m l i F E
m l i F E
Upper Molar Upper Premolar /Canine
l a t i g i D
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Large Patient
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Appendix D Alarm Conditions
AutoSet Timer Alarm Conditions Code Fault /Error X-ray requested A 01 during cool-down period A A A A
Signal Green lamp (System Ready) flashing Green lamp (System Line voltage below 02 Ready) and red lamp lower limit (Alarm) flashing Corrected exposure Green lamp (System 05 factor greater than Ready) and red lamp maximum (Alarm) flashing System Ready (green) Line Frequency 06 lamp and Alarm (red) Detection Failure lamp flashing Exposure push Red lamp 07 button pressed at (Alarm) flashing power on
Action
System inhibited System inhibited
Reset By acknowledgement on the panel or when system cooled down Automatically when line voltage back in range
Maximum By acknowledgement exposure on the panel factor forced System inhibited Exposure inhibited
By switching system off and on again By acknowledgement on the panel
Exposure stopped A 08 by the operator
Red lamp (Alarm) flashing
System inhibited
By acknowledgement on the panel or after 1 m
Exposure stopped A 99 by the back-up timer
Red lamp (Alarm) switched on
System inhibited
By switching system off and on again
A 10
Back-up relay failure
Red lamp (Alarm) switched on
System inhibited
By switching system off and on again
A 11
Power switching device failure
Red lamp (Alarm) switched on
System inhibited
By switching system off and on again
A12
Line dips during exposure
Red lamp (Alarm) switched on
Exposure inhibited
By acknowledgement on the panel
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Appendix E Identification Labels
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Appendix F Cooling Curves COOLING CURVE OF X-RAY INSERT kJ
Time min COOLING CURVE OF TUBE HOUSING ASSEMBLY kJ
Time min 140315
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Содержание
- «Стоматологическая рентгеновская система FONA X70 Инструкция по эксплуатации Русский FONA X70 – Инструкция по эксплуатации FONA X70 Инструкция по эксплуатации Выпуск на . »
- ИНДЕКС ЧУВСТВИТЕЛЬНОСТИ ПЛЕНКИ
- ЧУВСТВИТЕЛЬНОСТЬ ПЛЕНКИ.
- ПРИКУСНАЯ РЕНТГЕНОГРАММА
- 4. УХОД И ТЕХНИЧЕСКОЕ ОБСЛУЖИВАНИЕ
- 5. УТИЛИЗАЦИЯ ВЫВЕДЕННОГО ИЗ ЭКСПЛУАТАЦИИ ОБОРУДОВАНИЯ
- 6. ЭЛЕКТРОМАГНИТНАЯ СОВМЕСТИМОСТЬ
Стоматологическая рентгеновская система FONA X70
Инструкция по эксплуатации
FONA X70 – Инструкция по эксплуатации
FONA X70 Инструкция по эксплуатации
Выпуск на русском языке
Версия 110329 Март 2011 г.
Код 69 500 70110
Произведено компанией Blue X Imaging S.r.l.
Via Idiomi 1/8-33 — 20090 Assago (MI) Italy (Италия) – www.bluex.it
Дистрибьютор: компания FONA Dental s.r.o.
Stefanikova 7 SK-811 06 Bratislava, Slovakia (Словакия) www.fonadental.com
1.3 Классификация оборудования
1.4 Обязанности пользователя
1.6 Рекомендации по технике безопасности
2. Технические данные
2.1 Питание системы
2.2 Блок рентгеновской трубки
2.3 Ограничитель пучка
2.4 Автоматический таймер AutoSet
2.5 Система механической подвески
3. ИНСТРУКЦИИ ПО ЭКСПЛУАТАЦИИ
3.1 Панель управления
3.2 Ограничитель пучка
3.3 Использование таймера AutoSet
3.5 Примечания к выполнению процедуры
3.6 Перемещение передвижного блока
3.7 Таблица временных параметров
4. УХОД И ТЕХНИЧЕСКОЕ ОБСЛУЖИВАНИЕ
4.3 Техническое обслуживание
5. УТИЛИЗАЦИЯ ВЫВЕДЕННОГО ИЗ ЭКСПЛУАТАЦИИ ОБОРУДОВАНИЯ
6. ЭЛЕКТРОМАГНИТНАЯ СОВМЕСТИМОСТЬ
6.1 Электромагнитное излучение
6.2 Устойчивость к электромагнитным помехам
6.3 Оборудование, не относящееся к жизнеобеспечению
6.4 Разделительное расстояние для оборудования, не относящегося к жизнеобеспечению. 14 Приложение A Системы и компоненты
Приложение B Обозначения
Приложение C Таблица значений экспозиции
Приложение D Ситуации срабатывания тревоги
Приложение E Идентификационные этикетки
Приложение F Кривые охлаждения
1. ВВЕДЕНИЕ 1.1 Поздравления Поздравляем! Вы приобрели современное оборудование, которое будет оказывать помощь в вашей профессиональной деятельности изо дня в день на протяжении многих лет подряд. Данное устройство произведено с использованием системы контроля качества, которая обеспечивает полное соответствие заданным техническим характеристикам.
1.2 Назначение Рентгенографическая система FONA X70 разработана для обеспечения потребностей в интраоральной рентгенографии в общей стоматологической практике. Возможна конфигурация систем для настенного монтажа либо передвижные варианты.
Поставляемые вместе с системой инструкции по эксплуатации, а также руководства по установке и техническому обслуживанию являются неотъемлемым компонентом изделия. Исходным языком инструкции по эксплуатации является английский.
1.3 Классификация оборудования
• IEC: FONA X70 относится к оборудованию класса I, типа B
• FDA (Управление по контролю качества пищевых продуктов и медикаментов США): FONA X70 является медицинским оборудованием класса II (21 CFR 872-1800).
1.4 Обязанности пользователя
Пользователь несет ответственность за выполнение следующих требований:
• Соблюдать инструкции и рекомендации, содержащиеся в настоящей инструкции по эксплуатации.
• Выполнять техническое обслуживание оборудования в соответствии с рекомендуемым производителем графиком технического обслуживания. В случае ненадлежащего технического обслуживания оборудования производитель (или его представитель) может освобождаться от ответственности за любые травмы, повреждения или отклонения от эксплуатационных характеристик, которые возникли вследствие этого.
• Немедленно сообщать в ответственные регулирующие органы, а также производителю либо его представителю о любых несчастных случаях, связанных с данным медицинским устройством, и о каких-либо нарушениях функций и качества работы, которые могут привести к летальному исходу, травмам либо представлять опасность для здоровья пациента или оператора.
В отчет для производителя необходимо включать такую важную информацию, как тип и серийный номер включенных в отчет устройств. Эти сведения указаны на технических этикетках.
1.5 Предупреждение Использование системы возможно только после правильной сборки и установки в соответствии с инструкциями производителя.
Аппаратура для рентгенографии вырабатывает ионизирующее излучение, которое может представлять опасность при недостаточном контроле. В соответствии с нормами действующего законодательства, рекомендуется допускать к работе с данным оборудованием только обученный персонал.
Даже в случае соответствия требованиям электромагнитной совместимости не рекомендуется использовать данное оборудование при наличии внешних электромагнитных полей (например, возникающих при работе мобильного телефона), которые могут взаимодействовать с электрическими контурами системы.
1.6 Рекомендации по технике безопасности
• Связанные с электричеством.
Снятие крышек устройства и доступ к цепям питания должны выполняться только квалифицированным специалистом по техническому обслуживанию.
Линии электропитания должны соответствовать требованиям безопасности и быть оснащены клеммами для защитного заземления.
Перед выполнением очистки либо дезинфекции выключите питание оборудования и отсоедините его от линии подачи сетевого напряжения (при помощи расположенного в помещении выключателя).
Регулярно (не реже одного раза в год) проверяйте состояние опор и кронштейнов системы подвески; при необходимости технического обслуживания оно должно выполняться сервисным специалистом.
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Не допускается использование данного оборудования в условиях наличия огнеопасных газов либо испарений.
Используйте данную систему только с прикрепленным круглым либо прямоугольным коллиматором (ограничитель пучка).
Необходимо использовать предусмотренные нормативами средства радиационной защиты.
Оператор должен обеспечивать безопасность пациента на протяжении процедуры.
Удостоверьтесь в том, что оборудование не остается без присмотра.
• Опасность для окружающей среды.
Данное оборудование содержит компоненты, которые необходимо утилизировать в соответствии с нормами действующего законодательства.
3.2 Ограничитель пучка В комплекты поставки систем входят ограничители пучка с кожно-фокусным расстоянием 21 см (8,27”) и полем облучения в форме окружности диаметром 6 см (2,35”) либо прямоугольника с диагональю 5,3 см (2,1”).
Данные устройства могут использоваться как для биссекторной, так и для параллельной методики получения изображений после установки под требуемым углом.
Пользователю рекомендуется разместить ободок коллиматора вплотную к держателю пленки или к лицу пациента для снижения возможной размытости изображения, которая может возникать вследствие незначительных перемещений во время облучения.
3.3 Использование таймера AutoSet Перед использованием таймера убедитесь в том, что в памяти таймера заданы правильные значения чувствительности пленки и длины ограничителя пучка.
ИНДЕКС ЧУВСТВИТЕЛЬНОСТИ ПЛЕНКИ
0,32 0,40 0,50 0,64 0,80 1,00 1,25 1,60 2,00 Тип E Тип D Тип D: Kodak Ultraspeed, Agfa Dentus M2; тип E: Kodak Ektaspeed Plus Таймер дает возможность коррекции времени экспозиции для контроля изменений дозы облучения, которые могут возникнуть вследствие внезапных сильных колебаний сетевого напряжения, с целью однородного засвечивания пленки. Данная функция может быть включена либо отключена в процессе установки при помощи специального переключателя (см. «Руководство по техническому обслуживанию и установке»).
Если данная функция включена, пользователь получает возможность отображения фактического времени экспозиции с учетом компенсации вместо исходно заданного значения.
Для установки требуемых рабочих параметров выполните приведенные ниже инструкции.
Для входа в меню настройки включите устройство, одновременно нажимая в течение 2 с три кнопки:, и.
Откроется режим выбора чувствительности пленки.
ЧУВСТВИТЕЛЬНОСТЬ ПЛЕНКИ.
Число на дисплее обозначает выбранный в данный момент индекс чувствительности пленки (см. таблицу выше). Нажмите кнопку ПЛЮС или МИНУС, чтобы изменить значение.
Нажмите кнопку КОМПЬЮТЕР для выхода (E) из режима ввода (переход в нормальный режим работы) или кнопку
ПРИКУСНАЯ РЕНТГЕНОГРАММА
для перехода к следующему (N) параметру.
ОГРАНИЧИТЕЛЬ ПУЧКА. На дисплее отображается число «20»
или «30», которое обозначает длину ограничителя пучка в см.
Нажмите кнопку ПЛЮС или МИНУС, чтобы изменить значение. Нажмите кнопку КОМПЬЮТЕР для выхода (E) из режима ввода (переход в нормальный режим работы) или кнопку ПРИКУСНАЯ РЕНТГЕНОГРАММА для перехода к следующему (N) параметру.
ФАКТИЧЕСКОЕ ВРЕМЯ ЭКСПОЗИЦИИ Сообщение на дисплее «ON» или «OFF» обозначает, будет ли отображаться фактическое (скорректированное) либо заданное значение времени экс
3.5 Примечания к выполнению процедуры
• Представленный диапазон содержит 18 выбираемых значений времени от 60 мс до 3,2 с. На каждом шаге изменяется энергия излучения, соответствующая минимальной степени почернения (плотность снимка). При переходе на каждые 3 шага вверх энергия излучения удваивается, на каждые 3 шага вниз – снижается в 2 раза.
• Если активирована коррекция изменения дозы вследствие колебаний напряжения, скорректированное время экспозиции будет уменьшаться при превышении номинального уровня сетевого напряжения либо увеличиваться при его снижении ниже номинального уровня.
• Во время облучения светится желтый индикатор рентгеновского излучения на панели управления и на ручном переключателе, а также звучит сигнал встроенного зуммера.
• В качестве дополнительной меры безопасности в устройстве имеется независимый резервный таймер, предназначенный для прекращения облучения в случае неисправности основного таймера.
• При возникновении тревожной ситуации загорается красный индикатор и появляется сообщение на дисплее панели управления.
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• В таймер встроена функция контроля присутствия оператора, которая прекращает облучение в том случае, если оператор отпускает кнопку экспозиции до истечения требуемого времени экспозиции. При этом отображается предупреждающее сообщение.
• Таймер дает возможность коррекции времени экспозиции для контроля изменений дозы облучения, которые могут возникнуть вследствие внезапных сильных колебаний сетевого напряжения, с целью стабильного засвечивания пленки. Данная функция может быть включена либо отключена в процессе установки при помощи встроенного переключателя.
• После каждой экспозиции таймер учитывает период охлаждения рентгеновской трубки и предотвращает немедленное начало облучения, при котором возможно превышение допустимых для рабочего цикла значений излучаемой энергии, с периодом ожидания не менее 3 с.
• Во время периода ожидания, который необходим для охлаждения, работа системы блокируется и индикаторы дисплея продолжают мигать, пока энергия требуемой экспозиции не будет соответствовать тепловой емкости рентгеновской трубки. После истечения периода ожидания дисплей перестает мигать и система переходит в состояние готовности.
3.6 Перемещение передвижного блока При любом перемещении передвижного блока складывающийся кронштейн должен быть установлен в положение «парковки».
4. УХОД И ТЕХНИЧЕСКОЕ ОБСЛУЖИВАНИЕ
4.1 Очистка Всегда отключайте подачу сетевого напряжения перед очисткой устройства. При помощи слабого мыльного раствора удалите отпечатки пальцев и другие загрязнения, не допуская при этом попадания жидкости внутрь оборудования. Пластмассовые поверхности можно протереть мягкой тканью, смоченной в слабом моющем средстве. Не допускается использование растворителей или моющих средств, которые могут вызвать коррозию устройства.
4.2 Дезинфекция Принадлежности, соприкасавшиеся с пациентом, необходимо очистить моющим средством (например, 2% р-ром аммиака) и затем выполнить дезинфекцию. При этом запрещается использование растворителей или дезинфектантов с коррозионными свойствами, которые могут привести к появлению трещин на пластмассовых поверхностях.
4.3 Техническое обслуживание Техническое обслуживание систем FONA X70 должно регулярно выполняться сервисным специалистом как минимум через каждые 24 месяца. Кроме того, регулярные проверки должны ежегодно проводиться оператором.
5. УТИЛИЗАЦИЯ ВЫВЕДЕННОГО ИЗ ЭКСПЛУАТАЦИИ ОБОРУДОВАНИЯ
Рентгенологическая система изготовлена из различных материалов, включая множество видов металлов (железо, алюминий, свинец, медь и др.), пластмассы, электронные компоненты и диэлектрическое масло в резервуаре рентгеновской трубки.
110329 69 500 70110 11/22 FONA X70 – Инструкция по эксплуатации Нанесенный на продукт символ с перечеркнутой мусорной корзиной на колесиках указывает на то, что после окончания срока эксплуатации продукт нельзя утилизировать как несортированные бытовые отходы, а следует собирать отдельно и доставлять в специализированные компании, выполняющие переработку либо утилизацию отходов от электрического и электронного оборудования (WEEE) в соответствии с действующим законодательством.
Такие меры способствуют предотвращению возможного неблагоприятного влияния на здоровье людей и окружающую среду, а также облегчают переработку материалов оборудования. При незаконной утилизации возможно применение штрафных санкций.
Согласно положениям Европейских Директив 2002/96/EC и 2003/108/EC, компания Blue X Imaging и ее региональные представители принимают на себя обязательства по обращению с отходами от электрического и электронного оборудования (WEEE), которые образовались в результате профессиональной деятельности.
6. ЭЛЕКТРОМАГНИТНАЯ СОВМЕСТИМОСТЬ
6.1 Электромагнитное излучение Система FONA X70 пригодна к использованию в указанной электромагнитной обстановке. Покупатель или пользователь системы FONA X70 обязан обеспечить использование устройства при перечисленных ниже параметрах электромагнитной среды.
Тест на излучения Соответствие Электромагнитная среда Излучаемые и кон- Радиочастотная энергия используется в системе FONA X70 дуктивные радиочас- только для выполнения внутренних функций. В связи с этим тотные помехи Группа 1 интенсивность радиочастотного излучения низкая и взаимоCISPR 11 (Стандарт действие с расположенным рядом электронным оборудованиМеждународного ем маловероятно.
специального комитета по борьбе с ра- Класс B диопомехами) Гармонические излу- Система FONA X70 пригодна для использования в жилых доСоответствует чения мах и в помещениях, которые непосредственно подключены к Класс A EN 61000-3-2 электросети низкого напряжения, используемой для электроснабжения жилых помещений.
Флуктуации напряжения/ пульсируюСоответствует щие излучения EN 61000-3-3
3,20 2,50 2,00 2,60 1,25 1,00 0,80 0,64 0,50 0,40 0,32
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Источник
FONA X70 Service and Installation Manual English
FONA X70 – X70 – Service Service and Installation Manual
FONA X70 Service and Installation Manual English Edition Version 140315 March 2014 2014 Code 69 500 70210 Manufactured by FONA S.r.l. Via Galilei 11 — 20090 Assago (MI) Italy Distributed by FONA Dental s.r.o. Stefanikova 7 SK-811 06 Bratislava, Slovakia www.fonadental.com
Table of Contents 1.
1.1 1.2 1.3 1.4 1.5 1.6 1.7 2.
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8
INTRODUCTION………………………………………… 4
PURPOSE……………………………………………….. 4 EQUIPMENT CLASSIFICATION ………………………… 4 APPLICABLE STANDARDS ……………………… …….. 4 ENVIRONMENTAL DATA ……………………………… 4 OBLIGATIONS OF THE INSTALLER ……………………. 4 WARNING ……………………………………………… 4 DEMONSTRATION …………………………………….. 4
TECHNICAL DATA ……………………………………… 5
2.1 2.2 2.3 2.4 2.5
SYSTEM SUPPLY ……………………………………….. 5 TUBE HOUSING ASSEMBLIES ………………………… 5 BEAM LIMITING DEVICE ……………………………… 5 AUTOSET TIMER ………………………………………. 5 MECHANICAL SUSPENSION SYSTEM ………………… 5
2.6
WEIGHTS ……………………………………….. …….. 5
6.
MAINTENANCE OF WALL ADAPTOR ………………. 20 MAINTENANCE OF SUPPORT ARM………………… 20 MAINTENANCE OF SCISSOR ARM …………………. 21 MAINTENANCE OF X-RAY HEAD…………………… 22 MAINTENANCE OF BEAM LIMITING DEVICE……… 22 MAINTENANCE OF TIMER ………………………….. 22 CHECKING FILAMENT PRE-HEATING TIME ………. 22 SERVICE FUNCTIONS………………………………… 23
MEASUREMENTS …………………………………….. 24
6.1 6.2 6.3 6.4 6.5
LINE VOLTAGE ………………………………………. 24 ANODE VOLTAGE – KVP …………………………… 24 ANODE CURRENT – MA ……………………………. 24 EXPOSURE TIME …………………………………….. 24 LEAKAGE RADIATION ……………………………….. 25
6.6 6.7
EARTH RESISTANCE- ………………………………… 25 EARTH LEAKAGE …………………………………….. 25
3. ………………………………………………………………….. 5
APPENDIX A SYSTEMS AND COMPONENTS ………… ………… 26
4.
APPENDIX B ICONS…………………………………………. 27 27
5.
ASSEMBLY AND INSTALLATION …………………… 6
4.1 4.2 4.3 4.4
WALL MOUNTED SYSTEMS ………………………….. 6 DIP SWITCH SETTING ……………………………….. 16 LAYOUT POWER BOARD TIMER ……………………. 17 MOBILE SYSTEMS ………………………. ………….. 18 18
4.5
MOUNTING THE TIMER …………………………….. 18
APPENDIX C EXPOSURE TABLE …………………………. 28 28 APPENDIX D ALARM CONDITIONS ……………………. 29 APPENDIX E IDENTIFICATION LABELS ………………… 30 APPENDIX F COOLING CURVES …………………………. 30
MAINTENANCE……………………………………….. 20
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The Control Panel 2
1
3
4 1
5 6
7 18 10
11
12
8 16
13
14
15
9
1 2
Device for emission of ionizing radiation on request Indication of system turned ON and ready
17
10 11
3
Irradiation
12
4
Alarm
13
5
Exposure time in s
14
6 7
Manual decrease of controlled technique factor Manual increase of controlled technique factor
15
Maxillary incisor Maxillary canine or premolar Maxillary molar Mandibular incisor Mandibular canine or premolar Mandibular molar
16
Bite-wing premolar
8
Patient build adult /large
17
Digital detector in use
9
Patient build child /small
18
Radiation exposure pushbutton
FILM SPEED INDEX 0.32 0.40 0.50 0.64 0.80 1.00 1.25 1.60 E type D type D type: Kodak Ultraspeed, Agfa Dentus M2 — E type: Kodak Ektaspeed Plus
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1. INTRODUCTION 1.1
Purpose
The FONA X70 X-ray Equipment is designed to fulfill the needs for high resolution intra-oral radiography in the general dental practice. The systems can be configured for wall, mobile solutions. The Operating Instructions and the Service and Installation Manuals supplied with the system are integral part of the product. The original language of the Operating Instructions is English.
1.2
Equipment Classification IEC: FONA X70 is a Class I, type B equipment FDA: FONA X70 is a Class II medical device equipment (21 CFR 872-1800).
1.3
Applicable Standards
The FONA X70 system configurations comply with the following standards. IEC 601-1 General requirements for safety IEC 601-1-2 Electromagnetic compatibility IEC 601-1-3 General requirements for radiation protection in diagnostic X-ray equipment Particular requirements for the safety of high volta ge generators of diagnostic IEC 601-2-7 X-ray generators Particular requirements for the safety of X-ray source assemblies and X-ray IEC 601-2-28 tube assemblies for medical diagnosis 21 CFR 1020.30 Diagnostic x-ray systems and their major components 21 CFR 1020.31 Radiographic equipment 93/42/EEC European Directive concerning medical devices (1993)
1.4
Environmental Data
Applicable ranges of temperature, humidity, and atmospheric pressure are reported here below both for operation and transport conditions. Ambient Transport & Storage Temperature from 10 to 40 °C from –20 to +50 °C Relative Humidity from 30 to 75% 10 to 90% Pressure from 700 to 1060 hPa from 500 to 1060 hPa
1.5
Obligations of the Installer
Obligations of the Installer are: To make sure that the line voltage specified by the Manufacturer of the equipment is available and within the specified range. For safety reasons verify that a proper switch is available to disconnect from line voltage supply when needed during installation. Install and test the equipment with due diligence according to the installation instructions from the Manufacturer. To provide the Operating Instructions to the User.
1.6
Warning
Use the system only after proper assembly and installation as per manufacturer’s instructions. X-ray equipment produce ionizing radiation that may be harmful if not properly controlled. It is therefore recommended that the equipment be operated by trained personnel onl y in accordance with existing law. Even if compliant to specifications of electromagnetic compatibility, it is recommended not to use the equipment in presence of external electromagnetic fields, such as th ose generated by cellular phones, which might interfere with the electronic circuits of the system.
1.7
Demonstration
In order to use of the system for demonstration purposes radiation emission has to be inhibited by disconnecting the supply cables to the X-ray head into the wall adaptor or into the timer. Cables to be disconnected are those leaving the connection block towards the X-ray head (“out”). Make sure that the disconnected cables are properly insulated to prevent undesired contacts with live points. This task has to be done by trained personnel only to avoid the risk of electrical shock.
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2.
TECHNICAL DATA
2.1
System Supply
Line Voltage Line Voltage Range Line Fuse Line Frequency Line resistance
2.2
Tube Housing Assemblies
Nominal Line Voltage Nominal Line Current Line Voltage Range Anode Voltage (peak tube potential) Anode Current (tube current) Nominal Power X-ray Insert Anode Focal Spot Inherent Filtration Duty Cycle Radiation Leakage
2.3
Precision Exposure factors Irradiation signal Hand-switch Overall size
Focus skin distance 21 cm (8.27”) Circular radiation field 6 cm (2.35”) diameter /Rectangular 3.2×4.2 cm (1.26”x1.65”) Maximum 10% eccentricity
110-120 for type 93 300 60200, 220-240 for type 93 300 60100 Exposure time in s, 18 steps from 0.06 s to 3.2 s (R10 scale) . Time in seconds is converted to number of mains pulses (20 ms at 50 Hz, 16.6 ms at 60 Hz). 0.06 0.12 0.25 0.50 1.00 2.00 0.08 0.16 0.32 0.64 1.25 2.50 0.10 0.20 0.40 0.80 1.60 3.20 ± 0.02 s or 5% (whichever the greater) Automatic setting through tooth type selection and patient build, for use with traditional film or digital sensor, or manual setting with plus and minus keys. Yellow light on hand-switch and on control panel plus acoustic buzzer Hand-switch with 3 m coiled cord, with remote mounting optional kit Width: 15 cm /6”, Height: 24 cm /9”½, Depth: 9 cm /3”½
Mechanical Suspension System
Wall Adaptor Arm Length Useful Reach Mobile Stand
2.6
6 A at 120 V for type 93 205 01300, 4 A at 230 V for type 93 205 01700 108 — 132 V for 93 205 01300, 207 – 253 V for 93 205 01700 70 kVp ± 8% at nominal line voltage 66 kVp ± 8% at nominal line voltage – 10% 74 kVp ± 8% at nominal line voltage+ 10% 7.0 mA ± 15% at nominal line voltage 5.3 mA ± 15% at nominal line voltage – 10% 8.3 mA ± 15% at nominal line voltage + 10% 0.4 kW at 70 kVp, 7 mA, 0.1 s 3 electrodes, grid control action models: OCX/70-G, RF8G070 Tungsten, angle 19° to the tube axis 0.8 (EN 60336:1995-04) > 2.5 mm Al (EN 60522: 1999) 1/30 < 0.1 mGy/h a 1 m (< 11.5 mR/h a 1 m)
AutoSet Timer
Supply Voltage Exposure factor
2.5
120 V for type 93 205 01300, 230 V for type 93 205 01700
Beam Limiting Device
Beam Limiting Device
2.4
115 V (from 99 V to 132 V in sub-ranges depending on THA mounted) 230 V (from 198 V to 264 V in sub-ranges depending on THA mounted) 108 — 132 V for type 93 205 01300, 207 — 253 V for type 93 205 01700 Slow Blow: 6.3 A at 115 V, 4 A at 230 V, second fuse for two phases or cord 50/60 Hz 1 Hz 0.4 Ohm at 115 V, 0.8 Ohm at 230 V Voltage regulation for maximum line current: 2.1% at 115 V, 1.4% V at 230 V
12 cm /4.7” width, 24 cm /9.4” height, 9 cm /3.5” depth Short (S): 30 cm /11.8”, Medium (M): 60 cm /23.6”, Long (L): 80 cm /31.5”, Extra Long (XL) 100 cm /39.4” Arm S: 138 cm /54.3”, M: 168 cm /66.1”, L: 188 cm /74”, XL: 208 cm / 81.9” Size 78 x 92 cm (30” ¾ x 36” ¼), Height: 186 cm /73” ¼” with scissor arm
Weights
Timer X-ray Head Circular BLD Rectangular BLD Scissor Arm
1.7 kg / 3.7 lb 6.6 kg / 14.5 lb 0.1 kg / 0.22 lb 0.2 kg / 0.44 lb 11.7 kg / 25.8 lb
Support Arm Wall Adaptor Mobile Stand
Arm S: 2.8 kg /6.2 lb , M: 4.0 kg /8.8 lb, L: 4.8 kg /10.6 lb, XL: 5.4 kg / 11,9 lb 1.3 kg / 2.9 lb 29.4 kg / 64.8 lb
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4. ASSEMBLY AND INSTALLATION 4.1
Wall Mounted Systems
4.1.1
Installation Options
The timer box can be mounted together with the X-ray head on the right of the wall adaptor or can be placed remote either inside or outside the examination room. The release hand-switch can be directly connected to the timer box or placed remote making u se of specific mounting kit including 10 m cable. A door contact and /or a second exposure button can be added via the internal socket on the timer board.
4.1.2
Unpacking
Unpack the components of the system and check the fol lowing: A Each item is in good conditions and was not damaged during transportation. B All the items for the desired system configuration are available. C The line voltage on the labels of timer and X-ray head are corresponding to the local line voltage.
4.1.3
T1
T3
T2
Structural Requirements
The wall adaptor has to be mounted in a convenient position on left or right side of the chair or on back wall (head of the patient). The maximum useful reach is of 208 cm (81.9” ) from the wall when using an 100 cm (39.4” ) support arm. The wall adaptor can be mounted with 2, 4, or 6 bolts, depending on wall quality. A Two bolts only (top and bottom central holes – T2, B2) are used when there is a solid slim column (e.g. iron mounting) with weak sides (e.g. wooden wall). Considering the requested safety factor, the top bolt has to withstand a load of 8878 N, comprehensive of a safety factor, i.e. about 2013 lbs or 906 kg. Proper screw to be selected for a solid B3 B1 B2 connection to the wall. Classes ISO 8.8 (M 8, M 8×1, M 8×1.25) or SAE Grade 5 (5/16” 18UNC, 5/16” 24 UNF) are recommended. B Four bolts, two on top sides (T1, T3) and two on bottom sides (B1, B3) is the regular mounting for solid (concrete) wall, but also on large metal plate. Considering the requested safety factor, each bolt at top has to withstand a load of 4439 N, comprehensive of a safety factor, i.e. about 1007 lbs or 453 kg. Proper expansion screw to be selected for a solid conn ection to the concrete wall; the permissible load of each screw has to be greater than 308 lbs (about 140 kg). On solid concrete use heavy duty metal anchors. On hollow bricks use injection chemical fixing. C Six bolts, three on top (T1, T2, T3) and three at bottom (B1, B2, B3) are required when the wall is not solid enough and the load has to be distributed on more points. Considering the r equested safety factor, each bolt at top has to withstand a load of 2959 N, comprehensive of a safety factor, i.e. about 671 lbs or 302 kg. In case the wall is not in condition to withstand the indicated l oad, corrective actions can be evaluated by adoption of reinforcing plates: D Large plate to fit vertical supports at 16” distance, with 4 mounting holes and one cable opening for the wall mount in the middle. E In case of a thin (wooden) wall not solid enough, the use of a steel counter plate 2 mm thick can be the solution. Make sure that the wall is solid enough to carry the load. F The use of two reinforcing steel plates of about 4 times the surface of the wall adaptor, one by each side of the wall, can help when a single plate l ooks not adequate; additional bolts have to be used t o hold together the two plates. Make sure that the wall is solid enough to carry the load.
Diameter M 8X1.25 M 8X1 5/16” – 18 UNC 5/16 –24 UNF
Recommended Bolts Class ISO 8.8 ISO 8.8 SAE- Grade 5 SAE- Grade 5
Core Section mm 36.6 39.2 33.8 37.41
INSUFFICIENT WALL OR HARDWARE STRENGHT MAY CAUSE THE WALL ADAPTOR TO PULL OUT FROM THE WALL AND THE FULL SYSTEM TO FALL ON TO THE PATIENT OR THE OPERATOR CAUSING INJURIES.
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FONA X70 – Service and Installation Manual 4.1.4
Electrical Requirements
The power line cable must be connected to the input terminals (IN) of the timer to supply the timer itself and to make available power for the X-ray head at the output terminals (OUT), upon request by the operator (via the hand switch). Power to the X-ray head is thus controlled by the timer (acting as a SWITCH).
INPUT POWER LINE
X-RAY HEAD
SWITCH IN
OUT WALL ADAPTOR
ELECTRONIC TIMER
The cables (2 poles plus ground) to connect the power line to the timer and the timer to the wall adaptor are not provided. Cables with large section conductors have minimum electrical resistance and voltage drop.
Wire Type AWG 14 AWG 12
Cross Section Area 2.08 mm2 3.31 mm2
Resistance/m 0.00829 Ohm/m 0.00521 Ohm/m
m/0.05 Ohm 6.0 m 9.6 m
The resistance between the ground provision in t he connecting block of the timer and the metal body of the tube housing assembly has not to exceed 0.1 Ohm. Proper section of the yellow green wire to be used in case remote mounting of the timer. The wall adaptor is provided with a common bolt for bonding and grounding blocked in place with a nut which has not to be removed. The grounding conductors to be connected as indicated below. First the conductor to ground provision in the connecting block of the timer (flat washer, ground provision, flat washer, lock-washer, nut). Second the bonding conductor of support arm plus, in case, the one of the cable in the scissor arm (flat washer, bonding conductors, flat washer, lock-washer, nut).
LOCK-WASHER FLAT WASHER BONDING CONDUCTOR OF SCISSOR ARM (IN CASE)
COMMON BOLT BONDING CONDUCTOR OF SUPPORT ARM GROUND PROVISION TO TIMER
NUT
NUT
FLAT WASHER LOCK-WASHER FLAT WASHER FLAT WASHER
BLOCKING NUT DO NOT REMOVE
METAL BODY OF WALL SUPPORT
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FONA X70 – Service and Installation Manual 4.1.5
Mounting and Connecting Sequence
Step 1
Mount the Wall Adaptor
Step 7
Connect the Hand-Switch
Step 2
Mount the Timer
Step 8
Optional Remote Hand-Switch
Step 3
Mount the Support Arm
Step 9
Mount and connect X-ray head
Step 4
Mount the Scissor Arm
Step 10
Mount the collimator
Step 5
Connect the Wall Adaptor
Step 11
Final Tuning and Set-Up
Step 6
Connect the Timer
4.1.6 A B
C D E F G
Mounting the Wall Adaptor
Take away the plastic cover removing the screws under the logo label. Use the Wall Adaptor plate or a template to mark the holes on the wall. Please note that the timer can be mounted close to the Wall Adaptor on the right side or in a remote position. Cabling should have been laid out accordingly. Make the holes in the wall according to the applicable type of mounting with two, four bolts, or six bolts, with or without reinforcing plate. Slide the logo-strip out from the plastic cover to access the screws and remove it from the metal frame. Mount the metal frame on the wall using proper heavy-duty metal anchors and make sure that the power cable enters from behind. Secure it to the wall ensuring it is leveled. Improper leveling might cause the arm to move and swing out of position. Perform wire connection and final set-up complying with recommended sequence of actions reported in the following.
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FONA X70 – Service and Installation Manual 4.1.7
Mounting the Timer
Use the mounting plate or the template to mark the holes on the wall. B Remove the plastic cover after having taken away the blocking screws behind the logo strip. Pay attention when disconnecting the flat cable of the control panel from the control board. C Drill the four holes in the wall and secure the timer making sure it is leveled. Cabling should have been laid out in accordance to mounting requirements. D Perform wire connection and final set-up complying with recommended sequence of actions reported in the following.
A
4.1.8
Mounting the Support Arm
Unpack the support arm and check for completeness of parts. Do not remove the rope to pull the cable of the Scissor Arm to the Wall Adaptor through the Support Arm. C Push back the cylinder of the side friction not to interfere, lightly grease the shaft of the extension arm and insert it into the wall adaptor. D Mount the rotation end-stop spacer and close the side friction without tightening.
A B
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FONA X70 – Service and Installation Manual 4.1.9
Mounting the Scissor Arm
WARNING. THE SPRINGS IN THE SCISSOR ARM MAY CAUSE INJURY TO THE INSTALLER AS WELL AS DAMAGE TO THE ARM ITSELF IF NOT HANDLED PROPERLY. DO NOT REMOVE THE BINDING STRING UNTIL WHEN NECESSARY
Light grease the shaft at the base of the arm and make sure the ring spacer is in place; push back the cylinder of the friction into the support arm not to interfere during the insertion of the shaft. B Secure the trailing rope to the end of the electrical cable of the Scissor Arm. C Pull the other end of the trailing rope to drive the electrical cable of the Scissor Arm through the Support Arm out into the Wall Adaptor. D Hold the opening section of the Scissor Arm, carefully remove the safety string and allow the arm to open slowly, away from people. E Perform final set-up complying with recommended sequence of actions reported in the following.
A
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FONA X70 – Service and Installation Manual 4.1.10 Connecting the Wall Adaptor with Timer at side
MAINS LINE INPUT TO TIMER YELLOW-GREEN BONDING CONDUCTOR OF SUPPORT ARM
SUPPLY CABLE OUTPUT TO TUBE HEAD
SUPPLY CABLE FROM TIMER TO TUBE HEAD
YELLOW-GREEN GROUND PROVISION TO TIMER YELLOW-GREEN GROUND PROVISION FROM MAINS A B C
YELLOW-GREEN GROUND PROVISION ON TIMER
Pass the conductor of the grounding provision (already connected to the common bolt) into the timer for connection to the central ground point in the connecting block (protective earthing). Connect the grounding provision of the extension arm to the common bolt on the wall plate (flat washer, ground provision, lock-washer, nut). Pass through the supply cable of the arm into the timer for connection to the OUT positions (supply cable output to X-ray head).
4.1.11 Connecting the Wall Adaptor with Timer remote A
In case the connection to the mains is done starting from the wall adaptor a 5 position connection block has to be mounted. This approach is r ecommended allowing for a lower ground resistance. a The ground wire of the mains has to be connected i n first position on the common bolt and blocked with a nut. b The mains line goes to the remote timer and back through the connection bloc k to the X-ray head. c The other grounding provisions for support arm and of cable returning from the timer to be connected to the common bolt and blocked with a second nut. d The ground resistance to consider is actually the one of the cable in the scissor arm.
In case the connection to the mains is done through the timer box, the ground resistance to consider includes the wire from the timer to the wall adaptor. a Prepare the terminations of the cable for remote connection of timer with tips to fit the connecting blocks in timer and connecting blocks plus the common bolt for grounding in wall adaptor. Make sure the copper section of the yellow green wire i s large enough (see section 0, b Electrical Requirements, at page 7). B
YELLOW-GREEN TO COMMON BOLT ON WALL ADAPTOR WALL ADAPTOR SIDE
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FONA X70 – Service and Installation Manual C
Remove from the common bolt for bonding and grounding on the wall adaptor the existing cable for ground provision.
BOLT FOR BONDING AND GROUNDING
SUPPLY CABLE FROM REMOTE TIMER TO TUBE HEAD
SUPPLY CABLE TO TUBE HEAD YELLOW-GREEN BONDING CONDUCTOR SUPPORT ARM
YELLOW-GREEN GROUND PROVISION FROM TO TIMER
YELLOW-GREEN BONDING CONDUCTOR SCISSOR ARM
Connect the cable for remote connection of the timer by placing the ground wire as first conductor on the common bolt for bonding and grounding; block with washers and nut. E Place the phase and neutral wires to the connecting block. F Connect to the common bolt for bonding and grounding the bonding conductor of the extension arm and the one of the cable of the arm. G Connect the phase and neutral conductors of the supply cable in the arm to the connecting block. See section 0, H Electrical Requirements, at page 7 to determine cable length and maximum distance. D
CONNECTIONS IN THE REMOTE TIMER
CONNECTING BLOCK IN THE TIMER MAINS SUPPLY INPUT TO TIMER SUPPLY CABLE FROM REMOTE TIMER TO TUBE HEAD
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FONA X70 – Service and Installation Manual 4.1.12 Connecting the Timer
FUSE F4 NEUTRAL
GROUND
ZERO OHM RESITOR
LIVE
FUSE F2
HAND-SWITCH CONNECTION JUMPERS HAND-SWITCH SOCKET TST2
IN HAND-SWITCH SOCKET TST1
OUT
FUSE F1
Turn-off the voltage supply line. Connect the three wires from the voltage supply to the terminal block (IN on the left) but do not connect any outgoing wire (OUT on the right) to Wall Adaptor. B Make sure that the “live” conductor is the “hot” one: a Connect an AC voltmeter or a test light between the block terminal “live in” and “ground”. b Turn line voltage supply “ON”. If full line voltage is measured (test lamp lights) the wiring is correct. If not turn line voltage supply “OFF”, reverse “live in” and “neutral in” wires and repeat the measurement; eventually the full line voltage should be r ead between “line” and “ground” (test lamp lights). c Make sure no voltage is read between “neutral in” and “ground”; if not check line voltage distribution. C Test the timer for full functionality keeping the output cables disconnected not to supply the load. D Connect the load. a Turn OFF the line voltage supply line, b Connect the three wires of additional cable outgoing to the Wall Adaptor, Arm, Tube Housing Assembly. Live and neutral wires to the arm (X-ray head) can be interchanged.
A
Ref. F1 F2 F3 F4
Fuses of FONA X70 Timer 115 V 6.3 AT 5×20 6.3 AT 5×20 315 mAT 5×20 80 mAT 5×20
230 V 4 AT 5×20 4 AT 5×20 315 mAT 5×20 50 mAT 5×20
4.1.13 Connecting the Hand-Switch A
The hand-switch is provided with a 3 m coiled cord to be plugged one side in the hand-switch, the other side in the lower left corner of the timer’s board, either externally (connector TST1) or internally to the timer (connector TST2). Internal connection is for remote hand-switch or for additional control safety switches.
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FONA X70 – Service and Installation Manual B
Jumpers are available to activate properly the hand-switch connection: a Position TST1 to enable external socketTST1, b Position TST2 to enable the internal socket TST2, c Position TST1/2 f to enable the internal and the external sockets.
4.1.14 Optional Remote Hand-Switch The hand-switch can be remotely mounted by making use of the optional kit made of a remote box (wall holder) and connection cable 10 m long. The connection of the wires is here indicated. The wires of the switch are number 3 and 4 (those in the middle of the connector).
4.1.15 Mounting and Connecting the X-ray Head A
HANDGRIP PIPE B
C
D
E
RETAINING FORK F
Remove the handgrip pipe from the arm and place it onto the tube-head shaft of the coupling yoke. Lubricate the shaft, insert it into the arm passing the cables into the coupling yoke, then hold it in place with the retaining fork. Attach the connectors of the supply and grounding wires and push them into the side opening of the coupling yoke. Pull down the O-ring and push-up the handgrip pipe, then fix it in place with the screw at bottom. Verify smooth movement of the tube head around its vertical and horizontal axis. Tune side friction if necessary referring to section 5.4, Maintenance of X-ray Head, at page 22 for details. Mount the cover on the yoke opening eventually.
COUPLING YOKE
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FONA X70 – Service and Installation Manual 4.1.16 Beam Limiting Device A
Mount the beam limiting device on the tube- head and lock it close with a clock-wise rotation .
4.1.17 Final Tuning and Set-Up A
Remove the line voltage fuse(s) from the timer (Fuse 1 and Fuse 2).
B
Tune friction screw in Wall Adaptor for rotation of Support Arm (see section 5.1, Maintenance of Wall Adaptor at page 20 for details).
C
Tune friction screw in Support Arm for rotation of Scissor Arm around it vertical axis (see section 5.2, Maintenance of Support Arm at page 20).
D
The friction points in the scissor arm and those for the rotation of the X-ray head around its horizontal axis are tuned in factory. Should you need to repeat the procedures refer to sections 5.3, Maintenance of Scissor Arm, at page 21 and 5.4, Maintenance of X-ray Head, at page 22, respectively.
E
Make sure the Timer switch is in the “OFF” position.
F
Set the dip switches SW2 as indicated in the following to define: a Enable/disable function for correction of exposure in presence of line voltage fluctuations. b The nominal line voltage of the X-ray head (see label). c Set the pre-heating time according to type of X-ray insert used in the X-ray head assembly; the measured value is marked on the X-ray head.
G
Put back the line voltage fuse(s).
H
Put back all plastic covers and logo strips.
I
Connect the system to the line voltage by switching the general line voltage switch on and/or plug the power cord into the wall socket.
J
Switch the timer “ON”.
The system is now ready for functional checks.
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FONA X70 – Service and Installation Manual 4.2
Dip Switch Setting
DIP 4 NOT USED
DIP 1 TECHNIQUE FACTOR CORRECTION
DIPS 2-3 TUBE HEAD
DIPS 5-6-7 PRE HEATING TIME
DIP 1 Technique Factor Correction
DIPS 5 – 6 – 7 Pre Heating Time
Disabled
100 ms
Enabled
120 ms
DIPS 2- 3 Tube Head Type
140 ms
110 or 220 VAC
160 ms
115 or 230 VAC
180 ms
120 or 240 VAC
200 ms
127 or 250 VAC
220 ms DIP 4 Not used
DIP 8 NOT USED
240 ms DIP 8 Not used
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FONA X70 – Service and Installation Manual 4.3
Layout Power Board Timer
SET-UP MICROSWITCHES
POWER SUPPLY 5 V LED
KEYBOARD CONNECTOR BACK UP TIMER TEST POINT & LED
MICROPROCESSOR WATCH DOG LED POWER SUPPLY 24 V LED
FUSE 4 T50mA @230V T80mA @115V
JUMPER FUSE 2
5VA TRANSFORMER PRIMARY 115/230 V SECONDARY 18 V
FUSE 3 T 315 mA
HANDSWITCH JUMPERS
FUSE 1 & FUSE 2 T4A @230V T6.3A @115V
INPUT MAINS LINE NEUTRAL & LIVE
OUTPUT LINE TO TUBEHEAD
MAINS SWITCH HANDSWITCH SOCKETS
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FONA X70 – Service and Installation Manual 4.4 4.4.1
Mobile Systems Unpacking
Unpack the components of the system and check the following: A Each item is in good conditions and was not damaged during transportation. B All the items for the desired system configuration are available. C The line voltage on the labels of timer and X-ray head correspond to the existing local line voltage.
4.4.2
Room Preparation
Make sure that a wall socket is available close to the dental chair in reach of the mobile X ray equipment. Such a socket has to be provided with connection to the protective grounding. The line voltage cable can come without plug to be added according to the local standard.
4.4.3
Mounting and Connecting Sequence
Step 1
Assemble the Mobile Stand
Step 2
Mount the Scissor Arm
Step 3
Mount the Scissor Arm
Step 4
Mount the Timer
Step 5
Connect the Line Voltage Cable
Step 6
Connect the Timer
Step 7
Activate second Fuse
Step 8
Mount and connect X-ray head
Step 9
Mount the collimator
Step 10
Final Tuning and Set-Up
4.4.4
Assembling the Mobile Stand
A Mount the legs below the central base. B Mount rear wheels and front wheels with brakes. C Attach the pole with timer plate. D Complete the stand with cable holder and handles
4.4.5 A B
4.5
Mounting the Arm
Loosen the friction and push back the cylinder of the same not to interfere during shaft insertion. Insert the arm. Refer to section 4.1.9 at page 10 for details.
Mounting the Timer
The timer is blocked in place with four bolts.
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FONA X70 – Service and Installation Manual 4.5.1
Connecting the Line voltage cable
The line voltage cable for the mobile has to be completed with local plug. B The power supply cord bonding conductor has to be blocked (first) to the common bolt for bonding and grounding using lock-washer and nut. C The grounding wire for the timer is then placed on the same common bolt and blocked (second) with lock- washer and nut. D Connect the grounding wire for the timer to the ground provision on the terminal block of the timer and the two line wires of the power cord to the input points of the terminal block of the timer.
A
4.5.2
Connecting the Timer
For the connection of the output cable to the timer please refer to section 4.1.11 at page 13.
4.5.3
Activation of Fuse 2
Units provided with supply cord and plug must be equipped with fuses on both line phases. The activation on the second fuse is done by cutting the Jumper Fuse 2 (zero Ohm resistor) close to Fuse F2. See position on layout in section 0 at page 17.
4.5.4
POWER SUPPLY CORD BONDING CONDUCTOR
Mounting and Connecting the X-ray Head
Refer to section 4.1.15 at page 14.
4.5.5
Mounting the Beam Limiting Device
Refer to section 0 at page 14.
4.5.6
Final Tuning and Set-Up
Refer to section 4.1.17 at page 15.
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5. MAINTENANCE Here in the following the list of recommended maintenance actions to keep the FONA X70 system in compliance with the Performance Standard. It is the responsibility of the User to maintain the equipment in compliance with the standard. Failure of the User to properly maintain the equipment may relie ve the Manufacturer, or its Agent, from responsibility for any injury, damage or non compliance which may result. Maintenance for the FONA X70 system to be done regularly by a service technician at least once every 24 months, with regular checks performed by the operato r every year. Any defect or malfunction should be corrected immediately by qualified personnel with adequate training. WARNING.
Any defective item affecting a safe use must be repaired or replaced Only original certified components and spare parts mus t be used for repairs or replacements. Correction of damages to the identification labels to be handled with the Manufacturer. Any defect or non-compliance must be reported promptly to the Manufacturer or to its Local Agent. Always disconnect the system from the line voltage supply using the general line voltage switch for the room where the equipment is located before performing any maintenance activity Avoid using liquid or spray detergents which may enter into the equipment and cause corrosion. Avoid the use of solvents or corrosive detergents which can damage painted surfaces and plastic covers.
5.1
Maintenance of Wall Adaptor
POSITION OF 21 DISK SPRINGS IN FRICTION SCREW 7 GROUPS OF 3
FRICTION SCREW
Remove the cover and verify that the mounting is closely connected to the wall and stays firm and steady during the movements of the system. B Verify for proper connection of grounding wires to the common bolt. C Check friction during rotation of Extension Arm and adjust if needed. D Verify that the technical label with identification data outside the plastic cover at bottom is in place and is readable.
A
5.2
BOLT FOR BONDING AND GROUNDING
Maintenance of Support Arm
POSITION OF 15 DISK SPRINGS IN FRICTION SCREW 5 GROUPS OF 3 FRICTION SCREW Slide partially out the extension arm from wall mount, inspect for wear of the joint and lubricate for smooth rotation. B Check friction during rotation of Arm and adjust relevant screw if needed. C Verify that the technical label with identification data is in place and is readable.
A
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FONA X70 – Service and Installation Manual 5.3
Maintenance of Scissor Arm
FRICTION POINT 3
SPRING TUNING POINT
FRICTION POINT 2 SPRING TUNING POINT
A B
LABEL
FRICTION POINT 1
C
D E F G
FRICTION POINT 4
Balance the arms (2 sections) and tune frictions (4 points) if needed in normal conditions with X-ray head mounted. To balance the arm, for each arm’s section: a Remove plastic covers at the joints. b Reduce the friction at the 2 friction points by loosening the socket set screw (allen) into the female friction pin which is blocking male and female pins together, then loosen them to reduce friction. c WARNING. Trying to loosen the friction pins without having loosen the socket set screw might lead to breaking the friction pins. d Tune the springs using an allen key for even balancing with arm section in intermediate position. UNLOCK e Tighten the two friction pins for little SOCKET SET SCREW resistance to the movement, and WITH ALLEN KEY eventually tighten the socket set screw (allen) into the female friction pin to block male and female friction pins together.
ALLEN KEY
Specifically for the arm, at least ALLEN KEY every 24 months in case of normal use or after every 5000 cycles performed, have the service technician inspect for wear of pins and levers. a Remove plastic covers. b Check for wearing out of pin and levers, starting from the joint at the base of the arm. c Make sure no part is loose and no vibrations are occurring during movements. d Apply silicon spray lubricant if needed. e Replace the worn out parts or the arm itself if they appear damaged. To replace defective pins or levers a have the X-ray head disconnected with arm fully open to avoid injuries for sudden opening. b Loosen completely the two springs of the arm before extracting pins or removing levers. Mount back the X-ray head if removed and secure it with the retaining fork. Slide partially out the Scissor Arm from the Support Arm, inspect for wear of the vertical joint and lubricate for smooth rotation. Verify that the label with identification data is in place and is readable.
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FONA X70 – Service and Installation Manual 5.4
Maintenance of X-ray Head
HOLDING SCREW BLOCKED
POSITION OF 8 DISK SPRINGS IN FRICTION SCREW 4 GROUPS OF 2 A B C
D E F G
Inspect for damage/wear to the X-ray tube-head and support system. Inspect for oil leakage. Replace tube-head if FRICTION necessary. SCREWS Check for position stability. If necessary remove the cap on the yoke side, tune the three friction screws (with disk springs) to be moderately tight for smooth rotation. The fourth one without disk springs must be blocked in place Check that electrical cables are correctly twisted and not damaged or worn down. Verify that the technical label with identification data is in place and is readable. Dismount the tube-head from the arm and lubricate the pin for smooth rotation. Warning: remove the tube-head with the arm completely open to avoid t he risk of injuries. Check the retaining clip and replace if worn down. Do not mount the tube-head until all checks of the suspension system are completed.
5.5
Maintenance of Beam Limiting Device
A Verify that the collimator is properly mounted and firmly closed. B Verify that the internal cone is not damaged. Replace the collimator if necessary. C Verify that the technical label with identification data is in place and is readable.
5.6
Maintenance of Timer
Inspect the panel for damages on the surface. Inspect the cable of the exposure switch for wear. Check that all lights (except the yellow one) are working when the system is switched on. Perform a functional check with verification of a) setting of dip switches, b) yellow light, c) buzzer, d) alarm A07 for “Exposure push button pressed at power on”, e) alarm A08 for “Exposure stopped by the operator”. E Verify that the fuses mounted comply with those indicated on the label and listed below. F Verify that the technical label with identification data is in place and is readable.
A B C D
Ref. F1 F2 F3 F4 5.7
Fuses of FONA X70 Timer 115 V 6.3 AT 5×20 6.3 AT 5×20 315 mAT 5×20 80 mAT 5×20
230 V 4 AT 5×20 4 AT 5×20 315 mAT 5×20 50 mAT 5×20
Checking Filament Pre-Heating Time
During the life of the system the wearing down of the filament may result in a different pre-heating time (PHT). The value set at installation needs therefore t o be verified and in case corrected. A At a fixed distance measure the X-ray dose for exposure of 2.0 s (nominal irradiation of 100 pulses at 50 Hz, 120 at 60 Hz). B At same distance measure the dose for exposure of 0.2 s (nominal irradiation of 10 pulses at 50 Hz, 12 at 60 Hz). C If dose at 0.2 s is 1/10 of dose at 2 s, the value set for PHT is fine. D If dose at 0.2 s is lower than 1/10 of the dose at 2 s, PHT has to be increased. Proceed at steps of 20 ms until fine. E If dose at 0.2 s is higher than 1/10 of the dose at 2 s, PHT has to be reduced. Proceed at st eps of 20 ms until fine.
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FONA X70 – Service and Installation Manual 5.8 A
Service Functions Digital Volt Meter. This function allows the user to display the line voltage level. a
Enter this function by switching the system “on” while pressing at the same time the , the
b
B
, and the
keys.
Exit by switching the system off.
Test of Control Panel. This function is intended to test lights, buttons, and segments of numerical display on the control panel. a Enter this function by switching the system “ON” while pressing at the same time the , the b
, and the adult
keys.
By pressing the or keys all segments of the numerical display are scanned.
By pressing the X-ray pushbutton the “rAY” message is displayed. d By pressing each button on the panel, the corresponding lamp is turned “ON”; a second pressure would turn it “OFF”. e At the last button pressed the system exit this function. c
f
WARNING: Do not press the X-ray pushbutton as last button twice; the second time the timer becomes active and radiation could be emitted.
C
FIRMWARE VERSION. This function returns the code of the version of firmware loaded. a
Enter this function by switching the system “ON” while pressing at the same time the
b
, the
, and the adult
child
keys. Exit by switching the system OFF.
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FONA X70 – Service and Installation Manual
6. MEASUREMENTS All measurements to be done with the equipment supplied at nominal line voltage with specified line resistance. The tolerances on the measured values have to take into account the precision of each measurement instrument. Measurements have to be done by trained personnel only to avoid the risk of electrical shock.
6.1
Line Voltage
The Line voltage can be measured using a Volt Meter f or Alternate Current within the proper range. A service function can be activated on the timer to dis play the current line voltage in V and frequency in Hz (see section 5.8 of this Manual).
6.2
Anode Voltage – KVp
The kVp level is the actual peak value of the Anode volt age which stabilizes once the preheating time of the filament has elapsed (in about 0.2 s) and the high voltage transformer is actually loaded. The kVp level can be measured with a non-invasive kVp meter placed in front o f the BLD following the instructions in t he user manual of the instrument. A correct measure can be done with an exposure time of 500 ms or more having introduced a delay of the reading instrument of about 300 ms to allow the voltage level to stabilize after the pre-heating time has elapsed.
6.3
Anode Current – mA
WARNING. To prevent high voltage shock make sure the system is disconnected from the power supply when connections to the measurement points are performed. Electric discharge might occur in case of improper operation. The Anode current in mA is the actual average value of the tube current which raises when the filament has warmed -up, after the pre-heating time has elapsed. Remove the back cover of the tube-head, disconnect the jumper A1-A2 and replace it with a resistor of 1000 Ohm. The anode current can be read with a DC voltmeter connected to points A1 and A2, with the 1 V corresponding to 1 mA. After the measurement disconnect the 1000 Ohm resistor and put back the jumper.
6.4
A1
A2
Exposure Time
Here below the timing indications in s and in line pulses at 50 and 60 Hz as well as mAs at 7 mA. Pulses 50 Pulses 60 Pulses @50 Pulses @60 s mAs s mAs Hz Hz Hz Hz 0,06 0.42 3 4 0,50 3.50 25 30 0,08 0.56 4 5 0,64 4.40 32 38 0,10 0.70 5 6 0,80 5.60 40 48 0,12 0.88 6 7 1,00 7.00 50 60 0,16 1.12 8 10 1,25 8.75 62 75 0,20 1.40 10 12 1,60 11.2 80 96 0,25 1.75 12 15 2,00 14.0 100 120 0,32 2.24 16 19 2,50 17.5 125 150 0,40 2.80 20 24 3,20 22.4 160 192 The actual exposure (loading) time is “determined as the time interval between the instant when the tube current first rises above the 25% of its maximum value and the instant when it finally falls below the same value”. In order to assure the requested exposure time (irradi ation), the pre-heating time of the insert used, which has been set-up at installation, is taken into co nsideration. The actual switch-on time (SOT) of the X-ray head assembly is therefore the sum of the filament pre -heating time (PHT) and of the requested exposure time (RET). SOT = PHT + RET The measurement of the exposure time can be done wi th kVp & Time meters with the ability to t rigger at 75% of maximum kV level. Exposure time can also be measured after having connected a resistor of 1000 Ohm between points A1 and A2 on the small circuit board on the back of t he X-ray head, by monitoring the voltage across it (tube current) with an oscilloscope, and counting the number of pulses in the time interval.
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FONA X70 – Service and Installation Manual When the function to correct the effects of line fluctuations on the emitted X-ray dose is activated, the exposure time is corrected in order to assure dose consistency. When the actual line voltage is lower than the nominal line voltage, the actual exposure time is increased. Conversely, when the actual line voltage is higher than the nominal line voltage, the actual exposure time is decreased. Do disable this correction function (dip switch number 1 of SW2 moved to OFF position) to verify exposure time accuracy.
6.5
Leakage Radiation
The value of leakage radiation of the X-ray tube assembly is measured at 1 m distance taking into account the energy provided in 1 hour. In case the measurement is performed at a distance different from 1 m, the value has to be properly corrected. The applicable technique factors for FONA X70 are of 70 kV and 7 mA. The point of maximum leakage has to be considered, excluding the direction of t he primary beam. The duty cycle factor has also to be taken into account for the computation of the actual dose rate. In case for example a measure is done at 50 cm distance from the source with an exposure of 1 s, the following computations have to be performed: A duty cycle of 1/30 means maximum of 1 s exposure every 30 s, i.e. 120 s per hour. Dose at 100 cm is computed taking into account the inverse square law, i.e. at twice the distance the dose intensity is reduced to one quarter. D1h100cm = D1s50cm * 120 * (50/100)2 = D1s50cm * 30 where: D1s50cm is the dose measured at 50 cm with 1 s exposure and D1h100cm is the dose computed at 1 m distance for the energy of 1 hour.
6.6
Earth Resistance-
The measurement of the earth resistance to be done after having disconnected the system for the power supply line. Using a voltage generator of not more than 6 V, 50/60 Hz, a current of 25 A is applied from 5 s to 10 s through the earth terminal in the connecting block of the timer to any metal part which can be in touch to the patient/operator (applied part). The voltage drop is then measured and the eart h resistance computed. The system complies for values up to 0,1 (extended to 0,2 in case of mobile system).
6.7
Earth Leakage
Connect the Timer to the measuring circuit as shown in the figure (R1=10 k 5%, R2=1 k 1%, C1=0,015 F 5%) A Set the input supply voltage (Vp) equal to 110% of the nominal supply voltage. B Connect a voltmeter (Vx with 1 MOhm input impedance) to the indicated points C Switch the Timer “ON” D Make two measures in Normal Conditions (NC with S1 “ON”) S5 “ON”: live and neutral conductors in normal condition. S5 “OFF”: swap of live and neutral conductors. E Make two measures in Single Fault Condition (SFC with S1 “OFF”). S5 “ON”: live and neutral conductors in normal condition. S5 “OFF”: swap of live and neutral conductors. Please note that 1V equals to 1mA. Values of leakage currents have to be within the limits of table below.
Limit of earth leakage current for X-ray equipment Type of connection Normal Condition Single Fault Condition to line voltage supply (S1 “ON”) (S1 “OFF”). Permanent 5 mA 10 mA With power cord 2.5 mA 5 mA
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Appendix A Systems and Components FONA X70 Systems at 230 V Description
Code
97 576 62320 97 576 62620 97 576 62820 97 576 62120 97 576 67820
Code
Wall Syst. Arm S 30 cm 230V Wall Syst. Arm M 60 cm 230V Wall Syst. Arm L 80 cm 230V Wall Syst. Arm L 100 cm 230V Mobile System 230V
FONA X70 Systems at 120 V Description
97 526 62320 97 526 62620 97 526 62820 97 526 62120 97 526 67830
Wall Syst. Arm S 30 cm 120V Wall Syst. Arm M 60 cm 120V Wall Syst. Arm L 80 cm 120V Wall Syst. Arm L 100 cm 120V Mobile System 120V UL/CSA
C C
G
B
F
A G H I F
L
E
D
ID A B C D E
Description Wall adaptor Support arm S 30 cm Support arm M 60 cm Support arm L 80 cm Support arm L 100 cm Scissor arm Mobile stand Mobile stand UL/CSA Wall plate 16”
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J
K
Code
ID
93 105 11000 93 150 17100 93 150 17200 93 150 17300 93 150 17400 93 150 12010 93 150 20080 93 150 20090 86 100 21500
F G H I J K L
Description X-ray head 7 mA 120 V X-ray head 7 mA 230 V AutoSet Timer 110-120 V AutoSet Timer 220-240 V 6 cm circular field BLD 3×4 cm X-ray field BLD Coiled cable Hand-switch W/O cable Kit remote hand-switch
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Code 93 205 01300 93 205 01700 93 305 60200 93 305 60100 91 300 00020 91 300 00040 76 190 25580 76 190 25596 93 300 02000
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Appendix B Icons IEC Type B Equipment
Compliance to European Community Requirements
X-ray On Irradiation
Compliance to Canadian and US Standards
Examine Annexed Documentation
Line voltage supply On — System Ready
Increase Exposure Time (one step)
Off (Disconnected from Line voltage Supply)
Decrease Exposure Time (one step)
On (Connected to Line voltage Supply)
Child – Small Patient
~
Adult – Large patient
Fuse
Upper Incisor
Protective Earth
Upper Canine/Premolar
N
Neutral Point (for equipment permanent connected to line)
Upper Molar
L
Live Point (for equipment permanent connected to line)
Lower Incisor
Lower Canine/Premolar
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Alternate Current
Inherent Filtration
Focal Spot
Lower Molar
Fragile, Handle With Care
Bite Wing — Interproximal
Fear of Humidity
Digital Receptor
Up Do Not Overturn
Radiography Push Button
Stacking Limit
Ionizing Radiation
Separate Collection, Do Not Dispose
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Appendix C Exposure Table FONA X70 — 70 kVp, 7 mA — Exposure Times in s
m l i F D
e c n a t s i D m c m 1 l i 2 F s u c o F
Lower Molar Lower Premolar /Canine Lower Incisor
e c n a t s i D m c m l 1 i 3 F s u c o F
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m l i F D
l a t i g i D
m l i F E
Small Patient
l a t i g i D
m l i F E
m l i F D
l a t i g i D
m l i F E
Large Patient
3,20
2,50
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
2,50
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
1,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
Bite Wing
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
Upper Incisor
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
0,08
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
0,08
0,06
m l i F D m l i F D
m l i F D
l a t i g i D
m l i F E
Small Patient
l a t i g i D
m l i F E
m l i F E
Upper Molar Upper Premolar /Canine
l a t i g i D
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Appendix D Alarm Conditions
AutoSet Timer Alarm Conditions Code Fault /Error X-ray requested A 01 during cool-down period A A A A
Signal Green lamp (System Ready) flashing Green lamp (System Line voltage below 02 Ready) and red lamp lower limit (Alarm) flashing Corrected exposure Green lamp (System 05 factor greater than Ready) and red lamp maximum (Alarm) flashing System Ready (green) Line Frequency 06 lamp and Alarm (red) Detection Failure lamp flashing Exposure push Red lamp 07 button pressed at (Alarm) flashing power on
Action
System inhibited System inhibited
Reset By acknowledgement on the panel or when system cooled down Automatically when line voltage back in range
Maximum By acknowledgement exposure on the panel factor forced System inhibited Exposure inhibited
By switching system off and on again By acknowledgement on the panel
Exposure stopped A 08 by the operator
Red lamp (Alarm) flashing
System inhibited
By acknowledgement on the panel or after 1 m
Exposure stopped A 99 by the back-up timer
Red lamp (Alarm) switched on
System inhibited
By switching system off and on again
A 10
Back-up relay failure
Red lamp (Alarm) switched on
System inhibited
By switching system off and on again
A 11
Power switching device failure
Red lamp (Alarm) switched on
System inhibited
By switching system off and on again
A12
Line dips during exposure
Red lamp (Alarm) switched on
Exposure inhibited
By acknowledgement on the panel
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Appendix E Identification Labels
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Appendix F Cooling Curves COOLING CURVE OF X-RAY INSERT kJ
Time min COOLING CURVE OF TUBE HOUSING ASSEMBLY kJ
Time min 140315
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Содержание
- «Стоматологическая рентгеновская система FONA X70 Инструкция по эксплуатации Русский FONA X70 – Инструкция по эксплуатации FONA X70 Инструкция по эксплуатации Выпуск на . »
- ИНДЕКС ЧУВСТВИТЕЛЬНОСТИ ПЛЕНКИ
- ЧУВСТВИТЕЛЬНОСТЬ ПЛЕНКИ.
- ПРИКУСНАЯ РЕНТГЕНОГРАММА
- 4. УХОД И ТЕХНИЧЕСКОЕ ОБСЛУЖИВАНИЕ
- 5. УТИЛИЗАЦИЯ ВЫВЕДЕННОГО ИЗ ЭКСПЛУАТАЦИИ ОБОРУДОВАНИЯ
- 6. ЭЛЕКТРОМАГНИТНАЯ СОВМЕСТИМОСТЬ
Стоматологическая рентгеновская система FONA X70
Инструкция по эксплуатации
FONA X70 – Инструкция по эксплуатации
FONA X70 Инструкция по эксплуатации
Выпуск на русском языке
Версия 110329 Март 2011 г.
Код 69 500 70110
Произведено компанией Blue X Imaging S.r.l.
Via Idiomi 1/8-33 — 20090 Assago (MI) Italy (Италия) – www.bluex.it
Дистрибьютор: компания FONA Dental s.r.o.
Stefanikova 7 SK-811 06 Bratislava, Slovakia (Словакия) www.fonadental.com
1.3 Классификация оборудования
1.4 Обязанности пользователя
1.6 Рекомендации по технике безопасности
2. Технические данные
2.1 Питание системы
2.2 Блок рентгеновской трубки
2.3 Ограничитель пучка
2.4 Автоматический таймер AutoSet
2.5 Система механической подвески
3. ИНСТРУКЦИИ ПО ЭКСПЛУАТАЦИИ
3.1 Панель управления
3.2 Ограничитель пучка
3.3 Использование таймера AutoSet
3.5 Примечания к выполнению процедуры
3.6 Перемещение передвижного блока
3.7 Таблица временных параметров
4. УХОД И ТЕХНИЧЕСКОЕ ОБСЛУЖИВАНИЕ
4.3 Техническое обслуживание
5. УТИЛИЗАЦИЯ ВЫВЕДЕННОГО ИЗ ЭКСПЛУАТАЦИИ ОБОРУДОВАНИЯ
6. ЭЛЕКТРОМАГНИТНАЯ СОВМЕСТИМОСТЬ
6.1 Электромагнитное излучение
6.2 Устойчивость к электромагнитным помехам
6.3 Оборудование, не относящееся к жизнеобеспечению
6.4 Разделительное расстояние для оборудования, не относящегося к жизнеобеспечению. 14 Приложение A Системы и компоненты
Приложение B Обозначения
Приложение C Таблица значений экспозиции
Приложение D Ситуации срабатывания тревоги
Приложение E Идентификационные этикетки
Приложение F Кривые охлаждения
1. ВВЕДЕНИЕ 1.1 Поздравления Поздравляем! Вы приобрели современное оборудование, которое будет оказывать помощь в вашей профессиональной деятельности изо дня в день на протяжении многих лет подряд. Данное устройство произведено с использованием системы контроля качества, которая обеспечивает полное соответствие заданным техническим характеристикам.
1.2 Назначение Рентгенографическая система FONA X70 разработана для обеспечения потребностей в интраоральной рентгенографии в общей стоматологической практике. Возможна конфигурация систем для настенного монтажа либо передвижные варианты.
Поставляемые вместе с системой инструкции по эксплуатации, а также руководства по установке и техническому обслуживанию являются неотъемлемым компонентом изделия. Исходным языком инструкции по эксплуатации является английский.
1.3 Классификация оборудования
• IEC: FONA X70 относится к оборудованию класса I, типа B
• FDA (Управление по контролю качества пищевых продуктов и медикаментов США): FONA X70 является медицинским оборудованием класса II (21 CFR 872-1800).
1.4 Обязанности пользователя
Пользователь несет ответственность за выполнение следующих требований:
• Соблюдать инструкции и рекомендации, содержащиеся в настоящей инструкции по эксплуатации.
• Выполнять техническое обслуживание оборудования в соответствии с рекомендуемым производителем графиком технического обслуживания. В случае ненадлежащего технического обслуживания оборудования производитель (или его представитель) может освобождаться от ответственности за любые травмы, повреждения или отклонения от эксплуатационных характеристик, которые возникли вследствие этого.
• Немедленно сообщать в ответственные регулирующие органы, а также производителю либо его представителю о любых несчастных случаях, связанных с данным медицинским устройством, и о каких-либо нарушениях функций и качества работы, которые могут привести к летальному исходу, травмам либо представлять опасность для здоровья пациента или оператора.
В отчет для производителя необходимо включать такую важную информацию, как тип и серийный номер включенных в отчет устройств. Эти сведения указаны на технических этикетках.
1.5 Предупреждение Использование системы возможно только после правильной сборки и установки в соответствии с инструкциями производителя.
Аппаратура для рентгенографии вырабатывает ионизирующее излучение, которое может представлять опасность при недостаточном контроле. В соответствии с нормами действующего законодательства, рекомендуется допускать к работе с данным оборудованием только обученный персонал.
Даже в случае соответствия требованиям электромагнитной совместимости не рекомендуется использовать данное оборудование при наличии внешних электромагнитных полей (например, возникающих при работе мобильного телефона), которые могут взаимодействовать с электрическими контурами системы.
1.6 Рекомендации по технике безопасности
• Связанные с электричеством.
Снятие крышек устройства и доступ к цепям питания должны выполняться только квалифицированным специалистом по техническому обслуживанию.
Линии электропитания должны соответствовать требованиям безопасности и быть оснащены клеммами для защитного заземления.
Перед выполнением очистки либо дезинфекции выключите питание оборудования и отсоедините его от линии подачи сетевого напряжения (при помощи расположенного в помещении выключателя).
Регулярно (не реже одного раза в год) проверяйте состояние опор и кронштейнов системы подвески; при необходимости технического обслуживания оно должно выполняться сервисным специалистом.
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Не допускается использование данного оборудования в условиях наличия огнеопасных газов либо испарений.
Используйте данную систему только с прикрепленным круглым либо прямоугольным коллиматором (ограничитель пучка).
Необходимо использовать предусмотренные нормативами средства радиационной защиты.
Оператор должен обеспечивать безопасность пациента на протяжении процедуры.
Удостоверьтесь в том, что оборудование не остается без присмотра.
• Опасность для окружающей среды.
Данное оборудование содержит компоненты, которые необходимо утилизировать в соответствии с нормами действующего законодательства.
3.2 Ограничитель пучка В комплекты поставки систем входят ограничители пучка с кожно-фокусным расстоянием 21 см (8,27”) и полем облучения в форме окружности диаметром 6 см (2,35”) либо прямоугольника с диагональю 5,3 см (2,1”).
Данные устройства могут использоваться как для биссекторной, так и для параллельной методики получения изображений после установки под требуемым углом.
Пользователю рекомендуется разместить ободок коллиматора вплотную к держателю пленки или к лицу пациента для снижения возможной размытости изображения, которая может возникать вследствие незначительных перемещений во время облучения.
3.3 Использование таймера AutoSet Перед использованием таймера убедитесь в том, что в памяти таймера заданы правильные значения чувствительности пленки и длины ограничителя пучка.
ИНДЕКС ЧУВСТВИТЕЛЬНОСТИ ПЛЕНКИ
0,32 0,40 0,50 0,64 0,80 1,00 1,25 1,60 2,00 Тип E Тип D Тип D: Kodak Ultraspeed, Agfa Dentus M2; тип E: Kodak Ektaspeed Plus Таймер дает возможность коррекции времени экспозиции для контроля изменений дозы облучения, которые могут возникнуть вследствие внезапных сильных колебаний сетевого напряжения, с целью однородного засвечивания пленки. Данная функция может быть включена либо отключена в процессе установки при помощи специального переключателя (см. «Руководство по техническому обслуживанию и установке»).
Если данная функция включена, пользователь получает возможность отображения фактического времени экспозиции с учетом компенсации вместо исходно заданного значения.
Для установки требуемых рабочих параметров выполните приведенные ниже инструкции.
Для входа в меню настройки включите устройство, одновременно нажимая в течение 2 с три кнопки:, и.
Откроется режим выбора чувствительности пленки.
ЧУВСТВИТЕЛЬНОСТЬ ПЛЕНКИ.
Число на дисплее обозначает выбранный в данный момент индекс чувствительности пленки (см. таблицу выше). Нажмите кнопку ПЛЮС или МИНУС, чтобы изменить значение.
Нажмите кнопку КОМПЬЮТЕР для выхода (E) из режима ввода (переход в нормальный режим работы) или кнопку
ПРИКУСНАЯ РЕНТГЕНОГРАММА
для перехода к следующему (N) параметру.
ОГРАНИЧИТЕЛЬ ПУЧКА. На дисплее отображается число «20»
или «30», которое обозначает длину ограничителя пучка в см.
Нажмите кнопку ПЛЮС или МИНУС, чтобы изменить значение. Нажмите кнопку КОМПЬЮТЕР для выхода (E) из режима ввода (переход в нормальный режим работы) или кнопку ПРИКУСНАЯ РЕНТГЕНОГРАММА для перехода к следующему (N) параметру.
ФАКТИЧЕСКОЕ ВРЕМЯ ЭКСПОЗИЦИИ Сообщение на дисплее «ON» или «OFF» обозначает, будет ли отображаться фактическое (скорректированное) либо заданное значение времени экс
3.5 Примечания к выполнению процедуры
• Представленный диапазон содержит 18 выбираемых значений времени от 60 мс до 3,2 с. На каждом шаге изменяется энергия излучения, соответствующая минимальной степени почернения (плотность снимка). При переходе на каждые 3 шага вверх энергия излучения удваивается, на каждые 3 шага вниз – снижается в 2 раза.
• Если активирована коррекция изменения дозы вследствие колебаний напряжения, скорректированное время экспозиции будет уменьшаться при превышении номинального уровня сетевого напряжения либо увеличиваться при его снижении ниже номинального уровня.
• Во время облучения светится желтый индикатор рентгеновского излучения на панели управления и на ручном переключателе, а также звучит сигнал встроенного зуммера.
• В качестве дополнительной меры безопасности в устройстве имеется независимый резервный таймер, предназначенный для прекращения облучения в случае неисправности основного таймера.
• При возникновении тревожной ситуации загорается красный индикатор и появляется сообщение на дисплее панели управления.
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• В таймер встроена функция контроля присутствия оператора, которая прекращает облучение в том случае, если оператор отпускает кнопку экспозиции до истечения требуемого времени экспозиции. При этом отображается предупреждающее сообщение.
• Таймер дает возможность коррекции времени экспозиции для контроля изменений дозы облучения, которые могут возникнуть вследствие внезапных сильных колебаний сетевого напряжения, с целью стабильного засвечивания пленки. Данная функция может быть включена либо отключена в процессе установки при помощи встроенного переключателя.
• После каждой экспозиции таймер учитывает период охлаждения рентгеновской трубки и предотвращает немедленное начало облучения, при котором возможно превышение допустимых для рабочего цикла значений излучаемой энергии, с периодом ожидания не менее 3 с.
• Во время периода ожидания, который необходим для охлаждения, работа системы блокируется и индикаторы дисплея продолжают мигать, пока энергия требуемой экспозиции не будет соответствовать тепловой емкости рентгеновской трубки. После истечения периода ожидания дисплей перестает мигать и система переходит в состояние готовности.
3.6 Перемещение передвижного блока При любом перемещении передвижного блока складывающийся кронштейн должен быть установлен в положение «парковки».
4. УХОД И ТЕХНИЧЕСКОЕ ОБСЛУЖИВАНИЕ
4.1 Очистка Всегда отключайте подачу сетевого напряжения перед очисткой устройства. При помощи слабого мыльного раствора удалите отпечатки пальцев и другие загрязнения, не допуская при этом попадания жидкости внутрь оборудования. Пластмассовые поверхности можно протереть мягкой тканью, смоченной в слабом моющем средстве. Не допускается использование растворителей или моющих средств, которые могут вызвать коррозию устройства.
4.2 Дезинфекция Принадлежности, соприкасавшиеся с пациентом, необходимо очистить моющим средством (например, 2% р-ром аммиака) и затем выполнить дезинфекцию. При этом запрещается использование растворителей или дезинфектантов с коррозионными свойствами, которые могут привести к появлению трещин на пластмассовых поверхностях.
4.3 Техническое обслуживание Техническое обслуживание систем FONA X70 должно регулярно выполняться сервисным специалистом как минимум через каждые 24 месяца. Кроме того, регулярные проверки должны ежегодно проводиться оператором.
5. УТИЛИЗАЦИЯ ВЫВЕДЕННОГО ИЗ ЭКСПЛУАТАЦИИ ОБОРУДОВАНИЯ
Рентгенологическая система изготовлена из различных материалов, включая множество видов металлов (железо, алюминий, свинец, медь и др.), пластмассы, электронные компоненты и диэлектрическое масло в резервуаре рентгеновской трубки.
110329 69 500 70110 11/22 FONA X70 – Инструкция по эксплуатации Нанесенный на продукт символ с перечеркнутой мусорной корзиной на колесиках указывает на то, что после окончания срока эксплуатации продукт нельзя утилизировать как несортированные бытовые отходы, а следует собирать отдельно и доставлять в специализированные компании, выполняющие переработку либо утилизацию отходов от электрического и электронного оборудования (WEEE) в соответствии с действующим законодательством.
Такие меры способствуют предотвращению возможного неблагоприятного влияния на здоровье людей и окружающую среду, а также облегчают переработку материалов оборудования. При незаконной утилизации возможно применение штрафных санкций.
Согласно положениям Европейских Директив 2002/96/EC и 2003/108/EC, компания Blue X Imaging и ее региональные представители принимают на себя обязательства по обращению с отходами от электрического и электронного оборудования (WEEE), которые образовались в результате профессиональной деятельности.
6. ЭЛЕКТРОМАГНИТНАЯ СОВМЕСТИМОСТЬ
6.1 Электромагнитное излучение Система FONA X70 пригодна к использованию в указанной электромагнитной обстановке. Покупатель или пользователь системы FONA X70 обязан обеспечить использование устройства при перечисленных ниже параметрах электромагнитной среды.
Тест на излучения Соответствие Электромагнитная среда Излучаемые и кон- Радиочастотная энергия используется в системе FONA X70 дуктивные радиочас- только для выполнения внутренних функций. В связи с этим тотные помехи Группа 1 интенсивность радиочастотного излучения низкая и взаимоCISPR 11 (Стандарт действие с расположенным рядом электронным оборудованиМеждународного ем маловероятно.
специального комитета по борьбе с ра- Класс B диопомехами) Гармонические излу- Система FONA X70 пригодна для использования в жилых доСоответствует чения мах и в помещениях, которые непосредственно подключены к Класс A EN 61000-3-2 электросети низкого напряжения, используемой для электроснабжения жилых помещений.
Флуктуации напряжения/ пульсируюСоответствует щие излучения EN 61000-3-3
3,20 2,50 2,00 2,60 1,25 1,00 0,80 0,64 0,50 0,40 0,32
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