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JOLLY Plus DR Series

TECHNICAL MANUAL
JOLLY Plus DR Series TECHNICAL MANUAL

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SUMMARY

CHAPTER 1 EQUIPMENT DESCRIPTION ........................................................................... 9

1.1 GRAPHIC SYMBOLS............................................................................................................... 11

1.2 UTILIZATION PURPOSES AND EQUIPMENT OPERATING LIFE ................................. 12


1.2.1 EQUIPMENT LIFE ..................................................................................................................... 12

1.3 TECHNICAL FEATURES ......................................................................................................... 13


1.3.1 ELECTRICAL FEATURES .......................................................................................................... 13
1.3.2 OPERATION FEATURES .......................................................................................................... 13
1.3.3 RADIOGRAPHIC FEATURE ...................................................................................................... 14
1.3.4 LOADING FACTORS ACCURACY ............................................................................................ 14
1.3.5 MECHANICAL FEATURES ........................................................................................................ 15
1.3.6 COLLIMATOR ............................................................................................................................ 15
1.3.7 MONOBLOC .............................................................................................................................. 16
1.3.8 DIGITAL IMAGE SYSTEM ........................................................................................................ 16
1.3.9 ENVIRONMENTAL DATA ......................................................................................................... 16

1.4 EQUIPMENT DESCRIPTION ................................................................................................ 17


1.4.1 MAIN ELEMENTS...................................................................................................................... 17
1.4.2 MEDICAL STATION .................................................................................................................. 18

1.5 LABEL ........................................................................................................................................ 19

1.6 DIMENSION............................................................................................................................. 20

1.7 REFERENCE STANDARD ....................................................................................................... 21

1.8 CLASSIFICATION ................................................................................................................... 21

1.9 SAFETY...................................................................................................................................... 21
1.9.1 INTRODUCTION ....................................................................................................................... 21
1.9.2 MECHANICAL SAFETY DEVICES ............................................................................................ 23
1.9.3 ELECTRICAL SAFETY DEVICES .............................................................................................. 23
1.9.4 PROTECTION FROM RADIATION .......................................................................................... 24
1.9.5 RESIDUAL RISKS ..................................................................................................................... 24

1.10 ELECTROMAGNETIC COMPATIBILITY (EMC) ............................................................. 26

1.11 DECLARATION OF RESPONSIBILITY .......................................................................................... 29

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CHAPTER 2 UTILIZATION ................................................................................................... 31

2.1 TRANSPORT OF THE EQUIPMENT ..................................................................................... 33

2.2 DAILY X-RAY TUBE WARM-UP PROCEDURE .................................................................. 34

2.3 X-RAY TUBE FORMATION ................................................................................................... 34

2.4 EQUIPMENT’S SWITCHING ON ......................................................................................... 35

2.5 ARM POSITIONING .............................................................................................................. 36

2.6 MONOBLOC AND COLLIMATOR DISPLACEMENT .......................................................... 37

2.7 COLLIMATOR .......................................................................................................................... 38


2.7.1 SETTING THE X-RAY FIELD ON THE COLLIMATOR FRONT PANEL ................................. 39

2.8 RADIOGRAPHIC TECHNIQUES .......................................................................................... 39


2.8.1 DIAGNOSTIC DUMMY PHANTOMS USED............................................................................. 39
2.8.2 WAY OF EXECUTION OF THE TESTS ................................................................................... 40
2.8.3 MEASURE .................................................................................................................................. 40
2.8.4 TAKING A RADIOGRAPHIC EXPOSURE ................................................................................ 41

2.9 WARNING MESSAGES .......................................................................................................... 42

2.10 LANGUAGE ........................................................................................................................... 48

2.11 DIGITAL RADIOGRAPHIC IMAGE ACQUISITION ..................................................... 48

2.12 END OF OPERATION ......................................................................................................... 48

CHAPTER 3 ORDINARY MAINTENANCE .......................................................................... 49

3.1 GENERAL RECOMMENDATIONS ........................................................................................ 51

3.2 ORDINARY MAINTENANCE................................................................................................. 51

3.3 CLEANING AND DISINFECTION ........................................................................................ 53

3.4 DISPOSAL ................................................................................................................................ 54

CHAPTER 4 ELECTRICAL AND ELECTRONIC COMPONENTS ..................................... 55

4.1 INTRODUCTION ..................................................................................................................... 57

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4.2 PANEL PC ................................................................................................................................. 58

4.3 ELECTRONIC BOX .................................................................................................................. 58

4.4 INVERTER ................................................................................................................................ 59

4.5 CAPACITORS BOX .................................................................................................................. 60

CHAPTER 5 INSTALLATION ................................................................................................61

5.1 INTRODUCTION ..................................................................................................................... 63

5.2 UNPACKING ............................................................................................................................ 63


5.2.1 UNPACKING OF THE EQUIPMENT ......................................................................................... 64

5.3 ELECTRIC INSTALLATION ................................................................................................... 64

5.4 ELECTRIC INSPECTION........................................................................................................ 64

5.5 MECHANICAL INSPECTION................................................................................................. 64

CHAPTER 6 ADJUSTMENTS & SETUP ...............................................................................67

6.1 TOOLS AND TEST EQUIPMENT ........................................................................................... 69

6.2 ADJUSTMENTS ........................................................................................................................ 69


6.2.1 kV VALUE ADJUSTMENT ......................................................................................................... 69
6.2.2 THE PERFORMANCE OF X – Ray EQUIPMENT (Mexican Standard) ................................. 70
6.2.3 mA VALUES ADJUSTMENT ..................................................................................................... 71

6.3 CONFIGURATION AND CALIBRATION ............................................................................. 72


6.3.1 HOW TO ENTER IN CONFIGURATION MODE ..................................................................... 75
6.3.2 COM PORT SELECTION........................................................................................................... 76
6.3.3 DAP AND COLLIMATOR SETTING ......................................................................................... 77
6.3.4 LANGUAGE SELECTION .......................................................................................................... 78
6.3.5 X-RAY TUBE SELECTION ........................................................................................................ 78
6.3.6 OPTIONS SELECTION ............................................................................................................. 79
6.3.7 COUNTER .................................................................................................................................. 80
6.3.8 CALIBRATION OF kVp GAIN .................................................................................................. 81
6.3.9 CALIBRATION OF FILAMENT CURRENT (SMALL AND LARGE FOCAL SPOTS) ............... 82

6.4 CAPACITORS DISCHARGE AND ACCESS TO THE CONTROL LOGIC ......................... 85

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CHAPTER 7 EXTRAORDINARYMAINTENANCE .............................................................. 87

7.1 CHECKING OF CORRECT OPERATION OF THE ARM RETAINER ................................ 89

7.2 DIELECTRIC OIL LEAKAGE FROM THE MONOBLOC ..................................................... 89

7.3 CHECK THE GOOD OPERATION OF THE PARKING BRAKES ....................................... 90

7.4 CHECK THE ARM BALANCING ............................................................................................ 91

7.5 CHECK THE BALANCING OF THE FORK-MONOBLOC ASSEMBLY .............................. 92

7.6 CHECK THE STEEL-CLAD ROPES CONSUMPTION ......................................................... 93

7.7 MECHANIC ADJUSTMENTS ................................................................................................. 94


7.7.1 BRAKE BLOCK ADJUSTMENT ................................................................................................. 94
7.7.2 UPPER COVER GUARD DETACHING ..................................................................................... 96
7.7.3 SPRING ADJUSTMENT ............................................................................................................ 97
7.7.4 ARM CLUTCH ADJUSTMENT ................................................................................................ 100
7.7.5 FORK JOKE ROTATION CLUTCH ADJUSTMENT ................................................................ 101
7.7.6 MONOBLOC ROTATION CLUTCH ADJUSTMENT ............................................................... 102
7.7.7 STEEL-CLAD ROPES AND THE MECHANICAL EQUALIZER REPLACEMENT ................... 102
7.7.8 COLLIMATOR DISMOUNTING.............................................................................................. 103
7.7.9 X-RAY FIELD CENTERING .................................................................................................... 103
7.7.10 COLLIMATOR LAMP REPLACEMENT ................................................................................... 103
7.7.11 POWER SUPPLY CABLE REPLACEMENT ............................................................................. 104

CHAPTER 8 TROUBLESHOOTING AND SPARE PARTS ............................................. 107

8.1 TROUBLESHOOTING ........................................................................................................... 109


8.1.1 LED INDICATORS .................................................................................................................. 110

8.2 SPARE PARTS LIST ............................................................................................................. 111

8.3 FUSES LIST............................................................................................................................ 113

CHAPTER 9 SCHEMATICS................................................................................................. 115

9.1 ELECTRONIC BOARD TOPOGRAPHIC LAYOUT ............................................................ 117

9.2 SCHEMATICS ........................................................................................................................ 124

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The Technical manual should be read before starting using the equipment.
It is recommended to follow strictly the instructions of the present in order to
avoid any illegitimate use of the unit. The unit is supposed to be used by
qualified and authorized people only.
The installation and maintenance must be carried out by people authorized by
the manufacturer.

The purchaser of the equipment does not buy the system software but only the
right to use the software licence. this is not an exclusive right and it is not
transferable.

THE ORIGINAL VERSION OF THIS DOCUMENT WAS WRITTEN IN ITALIAN AND


USED TO PRODUCE TRANSLATIONS INTO OTHER LANGUAGES. THE ORIGINAL
VERSION SHALL BE REFERRED TO IN THE EVENT OF A DISPUTE.

0051

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL s.r.l.


Via Enrico Fermi 52 Q/R
24035 Curno (Bergamo) Italy
Telephone: +39 035 4376381
Fax: +39 035 4376401
Web site: www.bmibiomedical.it
E-Mail: info@bmibiomedical.it

REVISIONS CHRONOLOGY

REVISION DATE MODIFICATIONS


03 28.09.2016 § 1.8 Classification
§ 1.9 Safety
§ 1.10 Modified EMC Directive (Recast)
new Warning message
new APR chart
new settings
Login Option
02 30.03.2016 General revision
01 02.11.2015 General revision
00 03.02.2014 First issue

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CHAPTER 1
EQUIPMENT DESCRIPTION

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1.1 GRAPHIC SYMBOLS

The following symbols are available in the technical manual, in the user manual and on the labels
applied on the equipment:
Symbol Description
CE compliance mark

Type B applied part

Refer to instruction booklet

Operating Instruction

Serial no.

Catalogue no.

Date of manufacture

Manufacturer

Keep in a dry place

This way up

Fragile

Do not use towing devices

Alternating current

General warning symbol

Caution: dangerous voltage


Caution: radioactive material or ionizing
radiation
Caution: non-ionizing electromagnetic radiation

Protective earth

Earth

Radiation filter or Filtration

'ON' (power)

'OFF' (power)

Small focal spot

Medium focal spot

Large focal spot

X-ray tube

Device requiring special disposal arrangements

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1.2 UTILIZATION PURPOSES AND EQUIPMENT OPERATING LIFE

JOLLY Plus DR series is composed, depending on power, by following models:


- Model 4 kW - fixed anode
- Model 20 kW - rotating anode
- Model 30 kW - rotating anode

The mobile equipment is suitable for many medical applications and is supposed to be used by
qualified people only, duly trained and informed about the risks deriving from Ionogenic radiations.
This system is not included in the list of devices requiring continuity of operation. This system does
not come into contact with the patient, only some parts of the device may accidentally touch the
patient. The contact with the operator is contemplated during the equipment operation. The contact
with the patient is non-invasive. The contact with the operator is required for reasons depending on
the equipment utilization.
The equipment has been specifically designed for radiological examinations and diagnostic
investigations carried out in Hospitals and Medical Centres. It is suitable for operation in:
- Respiratory System investigations
- Skeleton investigations
- Sport Medicine
- Paediatrics Orthopaedics
- First-Aid Stations
- Plaster Room
- Operating Theatre
- Traumatology
The typical range of using estimate is from 20 exposure per day to 150 exposure per day (1 day
= 24 hours period).

For paediatric applications are provided specific additional filters, to obtain a filtering
not less than 0.1 mm Cu or 3.5 mm Al

1.2.1 EQUIPMENT LIFE

The average life of this equipment depends on the life of the X-ray tube installed in the
monobloc. The compliance with the instructions of this Manual will make it possible to get the
maximum life duration of the X-ray tube. It is not always possible to know in advance when the X-ray
tube’s operation life is coming to an end. This component could even stop operating during the
examination of a patient. For this reason, it is recommended to check the focal spot yearly, in order to
find if there is any degradation of the anode, indicated by the increase of the focal spot dimension and
consequent worse image resolution.
The main causes of early wear and damages to the X-ray tube are:
- Filament prolonged heating
- Discharges in the tube
- Tube over current

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- Cold anode overcharge, caused by excessive loads after a long period of inactivity, with
consequent cratering of the track.

Here below how to limit untimely wear and damages to the monobloc:
1. The X-ray tube preheating cycle avoids the overheating since the tube reaches the
operating temperature slowly.

IF A HIGH VALUES EXPOSURE IS STARTED WHEN THE X-RAY TUBE IS STILL COLD, THE
ANODE COULD BE IRREPARABLY DAMAGED.

THE TUBE FORMATION PROCEDURE MAKES IT POSSIBLE TO REDUCE THE PROBABILITIES


OF DISCHARGE.

2. If a high values exposure is started when the device has not been used for a long time,
the X-ray tube could be irreparably damaged.
3. The X-ray tube overcharge is avoided by the software control on the preset kVp and mAs
values. The system prevents the exposure if these values exceed the maximum values
provided for the X-ray tube.
4. Filament temperature preparation. It is recommended to effect the preparation only
when the patient is positioned for the examination.

1.3 TECHNICAL FEATURES

1.3.1 ELECTRICAL FEATURES


Description Value
Main power supply Voltage: 230 Vac (115 Vac on demand)
Frequency: 50/60 Hz
Current consumption: 16A @ 230Vac (25A @ 115Vac on demand)
Line compensation ± 10% automatic
Total line resistance 0,4 Ω total
Supply socket (standard) 16A @ 230Vac 25A @ 115Vac
Insulating class EN60601-1 Class I with applied parts type B
Utilization conditions Continuous operation at intermitted load

Classification Directive 93/42/CEE according to annex IX: Class II b

1.3.2 OPERATION FEATURES

Description Value
X-ray exposure control • Remote control by wire
- Hand switch with spiral cable extendable up to 3.8 meter length
Pre-selected technique
• 2-point technique (kV, mA)
radiography (APR)
Free technique radiography • 2-point technique (kV, mA)
• 3-point technique (kV, mA, ms)
Safety and protections • Capacitors voltage
• Inverter over current
• mA min and max safety device
• Monobloc working temperature
• X-ray filament safety device
• X-ray over load safety device
• X-ray tube anode rotation
• X-ray tube HU (thermal unit)

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1.3.3 RADIOGRAPHIC FEATURE

Description Values
Model 4 kW 4 kW (40 mA - 100 kV @ 100 ms)
Max power Model 20 kW 20 kW (200 mA - 100 kV @ 100 ms)
Model 30 kW 30 kW (300 mA - 100 kV @ 100 ms)
H.T. control H. F. Inverter – Frequency 40 kHz
Max ripple ≤ 2% @ maximum power
kV value increasing time ≤ 3 ms
1 ms ÷ 6300 ms (35 steps)
Exposure time (1 • 2 • 3 • 6 • 8 • 10 • 12 • 15 • 20 • 25 • 30 • 40 • 50 • 63 • 80 • 100 • 125 • 150
(for all the model) • 200 • 250 • 300 • 350 • 400 • 500 • 630 • 800 • 1000 • 1250 • 1500 • 2000 • 2500
• 3000 • 4000 • 5000 • 6300)

kV value Model 4 kW 40 ÷ 110 kV (step 1 kV)


variation Model 20 kW
range 40 ÷ 125 kV (step 1 kV)
Model 30 kW

Model 4 kW 25 ÷ 100 mA (6 steps)


(25 • 40 • 50 • 63 • 80 • 100)

mA Range Model 20 kW 25 ÷ 300 mA (11 steps)


(25 • 40 • 50 • 63 • 80 • 100 • 125 • 160 • 200 • 250 • 300)

Model 30 kW 25 ÷ 400 mA (13 steps)


(25 • 40 • 50 • 63 • 80 • 100 • 125 • 150 • 200 • 250 • 300 • 350 • 400)

0,3 ÷ 200 mAs (29 steps)


Model 4 kW (0,3• 0,4 • 0,5 • 0,6 • 0,8 • 1 • 1,2 • 1,6 • 2 • 2,5 • 3,2 • 4 • 5 • 6,3 • 8 • 10 • 12,5 •
16 • 20 • 25 • 32 • 40 • 50 • 63 • 80 • 100 • 125 • 160 • 200)
mAs range 0,3 ÷ 250 mAs (30 steps)
2 point Model 20 kW (0,3• 0,4 • 0,5 • 0,6 • 0,8 • 1 • 1,2 • 1,6 • 2 • 2,5 • 3,2 • 4 • 5 • 6,3 • 8 • 10 • 12,5 •
technique 16 • 20 • 25 • 32 • 40 • 50 • 63 • 80 • 100 • 125 • 160 • 200 • 250)

0,3 ÷ 320 mAs (31 steps)


Model 30 kW (0,3• 0,4 • 0,5 • 0,6 • 0,8 • 1 • 1,2 • 1,6 • 2 • 2,5 • 3,2 • 4 • 5 • 6,3 • 8 • 10 • 12,5 •
16 • 20 • 25 • 32 • 40 • 50 • 63 • 80 • 100 • 125 • 160 • 200 • 250 • 320)

In compliance with clause 10.4.4 of NOM-229-SSA1-2002 (Mexican


THE PERFORMANCE OF X – Standard)
Ray EQUIPMENT µGy/mAs > 70
mR/mAs >7 with HVL= 2.3 mm Al

1.3.4 LOADING FACTORS ACCURACY

Parameter Accuracy
kV ± 5% of nominal value
mA ± 10% of nominal value
mAs ± 10% ±0.2 of nominal value
Time ± 5% of nominal value
Linearity e Reproducibility
Standard deviation of the average, (average 10 exposures) < 10%
Performance

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1.3.5 MECHANICAL FEATURES

Feature Value
Width 680 mm
Length 1095 mm
Height with locked arm 1580 mm
Focus-floor distance - variable from 450 to 2000 mm
Monobloc rotation in the yoke -45° / +167°
Monobloc yoke support rotation ± 90°
Collimator rotation ± 90°
Antistatic pivoting wheels
80 mm
diameter
Rear wheels diameter 250 mm
Weight - net ≅ 185 Kg
Unit displacement Manual
Radiographic cassettes holder Nr. 1 Flat panel detector format 35x43 cm (14x17 inches)

1.3.6 COLLIMATOR

Ralco R104/163E/A | Standard


Mobile blades Square field - single layer
Blades displacement Manual
Minimum 0x0 cm
Size of irradiated square radiographic field
Maximum 43x43 cm
Focus / film distance indication Retractable tape measure
Collimator lamp LED - Automatic switch Off after 30 s.
Inherent filtration 2.5 mm Al @ 75 kV
Collimator rotation angle ± 90°

ADDITIONAL INFORMATION CAN BE FOUND IN THE COLLIMATOR MANUAL, SUPPLIED WITH THE
EQUIPMENT.

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1.3.7 MONOBLOC

Monobloc Model 4 kW Model 20/30 kW


Anode type Fix Rotating 3000 r.p.m.
0.5 - 1.5 mm
Focus small and large 0.6 - 1.3 mm
Focus used: 1.5 mm
Anode target angle 12° 15°
Anode material Tungsten RTM
Anode maximum heat storage capacity 30 kJ (40 kHU) 80 kJ (107 kHU)
Anode maximum continuous heat dissipation 270 W 300 W
Small focus 10 kW
Monobloc maximum power 4 kW
Large Focus 30 kW
kV - monobloc maximum voltage 110 kV 130 kV
Monobloc thermal capacity 500 kJ (600 kHU) 600 kJ (800 kHU)
Monobloc continuous thermal capacity 55 W 55 W

FURTHER TECHNICAL INFORMATION ABOUT THE MONOBLOC COULD BE FOUND IN THE


COMPONENT TECHNICAL MANUAL SUPPLIED TOGETHER WITH THE EQUIPMENT.

1.3.8 DIGITAL IMAGE SYSTEM

REFER TO DIGITAL ACQUISITION USER AND SERVICE MANUAL.

1.3.9 ENVIRONMENTAL DATA

Description Transport and Storage Operating ambient


Maximum temperature From -15 °C to +70 °C From +10 °C to +40 °C
Relative humidity non condensing From 5% to 95% From 20% to 80%
3000 meters maximum 3000 meters maximum
Altitude pressure range
700 hPa / 525 mm Hg 700 hPa / 525 mm Hg

LONG-TERM STORAGE OVER 40 °C WILL REDUCE THE SERVICE LIFE OF ELECTROLYTIC


CAPACITORS.
TRANSPORT AND STORAGE IS LIMITED TO A MAXIMUM DURATION OF 120 HOURS BETWEEN 50
AND 70 °C.

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1.4 EQUIPMENT DESCRIPTION

1.4.1 MAIN ELEMENTS

11

1
16
2
9
3
10
4
8

18

17

12

13

14

15

Legend
1. Medical Station 2. Transport handles and parking brakes control
3. Supply cable support 4. Flat Panel holder
5. Bracket to lean the unit for overcoming little 6. Rear wheels diameter 250 mm
obstacles
7. Pivoting front wheels 8. Column
9. Arm 10. Arm retainer
11. Arm handles 12. Monobloc’s covers
13. Goniometer 14. X-Ray collimator
15. Handgrip 16. Hand switch for radiographic exposure
17. Automatic circuit breaker (Power ON/OFF) 18. Flat Panel cable’s support

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1.4.2 MEDICAL STATION

REFER TO DIGITAL ACQUISITION USER AND SERVICE MANUAL.

Here below are indicated the Medical station.

In addition the operator can interface the Medical Station through two external sockets,
respectively type USB and Ethernet, placed on the Medical Station’s support.

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1.5 LABEL

The following figure illustrates the position of the equipment’s adhesive label.
Here below you will find the labels as an example.

The monobloc label is placed inside the covers, as illustrated in the following picture.

or

In the picture below are shown the positions of collimator and DAP labels.

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1.6 DIMENSION

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1.7 REFERENCE STANDARD

The equipment complies with the following rules and directives:


Number Title
EN ISO 9001 Quality management systems - Requirements
93/42/EEC Directive concerning medical devices
EN ISO 14971 Medical devices – Application of risk management to medical devices
Medical devices -- Symbols to be used with medical device labels,
EN ISO 15223-1 labelling and information to be supplied -- Part 1: General
requirements
EN 1041 Information supplied by the manufacturer of medical devices
Medical devices – Quality management system – Requirements for
EN ISO 13485
regulatory purposes
Medical electrical equipment. Part 1: General requirements for basic
EN 60601-1
safety and essential performance
Medical electrical equipment. Part 1: General requirements for safety 2
EN 60601-1-2 – Collateral Standard: Electromagnetic compatibility – Requirements
and tests.
Medical electrical equipment. Part 1: General requirements for basic
EN 60601-1-3 safety and essential performance – Collateral Standard: Radiation
protection in diagnostic X-ray equipment.
Medical electrical equipment. Part 1: General requirements for basic
EN 60601-1-6
safety and essential performance – Collateral standard: Usability
Medical electrical equipment. Part 2: Particular requirements for the
EN 60601-2-28 safety of X-ray source assemblies and X-ray tube assemblies for
medical diagnosis
Particular requirements for the basic safety and essential performance
EN 60601-2-54
of X-ray equipment for radiography and radioscopy
NOM-229-SSA1-2002 Mexican Standard
EN 62304 Medical device software – Software life-cycle process

1.8 CLASSIFICATION

The Device is classed as follows:


• Protection against electric shocks: Class I with type B applied parts.
• Protection against harmful water infiltration: Standard.
• Level of safety in the presence of inflammable anaesthetic mixtures with air or oxygen
and with nitrous oxide: Not suitable for use in the presence of these mixtures.

1.9 SAFETY

1.9.1 INTRODUCTION

As a consequence, these instructions are to be carefully read and understood before putting the
equipment at work.
The X-ray equipment must only be used by skilled, qualified personnel, suitably trained and
informed with regard to protection against radiation and the use of X-ray equipment.
The manufacturer is ready to provide the after-sale servicing and, if required, to take care of the
installation.
The end user is responsible for ensuring compliance with applicable standards.

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Safety devices and circuits must not be moved, modified or excluded. The plug on the
equipment's power supply cable must only be inserted by authorised personnel and only when the
equipment is to be used.
The equipment must also not be used if any of the warning or alarm devices malfunctions. If the
equipment is used along with other apparatus, components or modules which could be incompatible,
it must be ensured that this poses no risk to patients or operators. In this event consult BMI
Biomedical International s.r.l.
As with any technical apparatus, this X-ray equipment must be used appropriately and be
checked and serviced regularly in accordance with instructions in the Maintenance chapter in this
manual.
BMI BIOMEDICAL INTERNATIONAL s.r.l. can only be liable for the safety of its products if
maintenance, repairs and/or modifications are carried out by the manufacturer or third parties
authorised by BMI Biomedical International in writing.

THE JURIDICAL BINDING VERSION OF THIS DOCUMENT IS THE ITALIAN LANGUAGE ONE.
ANY TRANSLATION, EVEN IF VERIFIED AND APPROVED BY THE MANUFACTURER, IS ONLY
SUPPLIED TO FACILITATE THE USER.

The equipment designed and manufactured by BMI Biomedical International are equipped with
advanced radiological systems to safeguard safety and environment.
The equipment are not dangerous to people and environment if used in the way described in this
manual.
The equipment is sold with the following clause: the manufacturer, its agents and representatives
decline all responsibility for any damage or injury deriving from the wrong utilization of this equipment
or due to lack of maintenance or to the utilization of not original spare parts.
Regarding the disposal of substances like the dielectric oil contained in the monobloc, the anti-X
protective lead, the electronic boards and the electronic components, the provisions of the law in force
both on the national territory and on the territory where the equipment is installed have to be
complied with.
BMI is a leading company in its field and constantly upgrades the equipment according to the
progressive technological knowledge.
Since this equipment emits X-rays, it must be exclusively used complying with the safety
instructions included in this manual and must not be used for other purposes than the diagnostic
ones.
The incorrect utilization of the equipment can cause temporary or permanent injuries.

IT IS NECESSARY TO BE FAMILIAR WITH THE EQUIPMENT TO BE AWARE OF POSSIBLE


DANGEROUS ANOMALIES. IN CASE OF ANOMALOUS OPERATION OR IF THERE IS ANY SAFETY
PROBLEM, ISOLATE THE EQUIPMENT TO AVOID ANY NOT AUTHORIZED UTILIZATION AND DO NOT
USE IT UNTIL THE PROBLEM HAS BEEN SOLVED BY QUALIFIED PERSONNEL.

AS THIS EQUIPMENT PRODUCES X-RAYS, IT MUST ONLY BE USED IN ACCORDANCE WITH THE
SAFETY INSTRUCTIONS CONTAINED IN THIS MANUAL AND IN COMPLIANCE WITH EXISTING
LEGISLATION IN THE COUNTRY WHERE IT IS INSTALLED.

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THIS X-RAY DIAGNOSTIC SYSTEM MUST NOT BE USED FOR PURPOSES OTHER THAN THOSE
OUTLINED IN THIS MANUAL.
AFTER THE EQUIPMENT IS INSTALLED, COMPLIANCE WITH ESSENTIAL REQUIREMENTS
STIPULATED BY DIRECTIVE 93/42/EEC MUST BE VERIFIED, AND RESPONSIBILITY ACCEPTED
FOR COMPLIANCE WITH APPLICABLE STANDARDS BOTH IN TERMS OF INITIAL START-UP AND
SUBSEQUENT USE OF THE EQUIPMENT.

THIS EQUIPMENT MUST NOT BE USED IF INFLAMMABLE GASES ARE PRESENT.

ONLY DOCTORS OR PEOPLE HAVING AN AUTHORIZATION ACCORDING TO THE LAW ARE


AUTHORIZED BY THE LAW TO USE THIS EQUIPMENT.

1.9.2 MECHANICAL SAFETY DEVICES

Position the equipment and apply the brakes.


• To displace the equipment only use the transportation handle.
• Do not hit any obstacle or structure.
• The equipment’s guards can be removed only for maintenance operations as provided
and described in the technical manual.

1.9.3 ELECTRICAL SAFETY DEVICES

The buyer is supposed to use only qualified people (specialized engineers of the manufacturer or
equivalent personnel of a servicing company) to carry out any maintenance intervention on the
equipment. The connections among the different parts of the device, the calibration and the testing
must be carried out by qualified people, authorized by the manufacturer.
Only duly trained and qualified people have access to the internal parts of this device or to the
disassembled parts.

WARNING: TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE
CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

DANGER OF ELECTRIC SHOCK. ALWAYS CHECK THE CONDITION OF THE DIFFERENTIAL SWITCH
AND OF THE EQUIPMENT SUPPLY CABLE.
THE SYSTEM MUST NOT BE USED IN THE PRESENCE OF ANY ELECTRICAL, MECHANICAL OR
RADIOLOGICAL FAULTS.
THE EQUIPMENT MUST ALSO NOT BE USED IF ANY OF THE WARNING OR ALARM DEVICES
MALFUNCTIONS.

THIS DEVICE IS CONNECTED WITH A PROTECTIVE GROUND DURING OPERATION. FOR THE
PATIENT’S AND THE OPERATOR’S SAFETY, ONLY DEVICES COMPLYING WITH THE SAFETY
STANDARDS, SUITABLE FOR DEVICES IN PERFECT OPERATING CONDITIONS, MUST BE USED.

THIS SYSTEM HAS NOT BEEN DESIGNED TO WORK NEAR A DEFIBRILLATOR.


NEVER USE A DEFIBRILLATOR ON A PATIENT IN CONTACT WITH THE MOBILE RADIOGRAPHIC
EQUIPMENT. THIS SYSTEM MUST BE HANDLED AS A CONDUCTIVE SURFACE AND POSITIONED
AS FAR AS POSSIBLE FROM THE PATIENT BEFORE EFFECTING A DEFIBRILLATION. IF ANY PART
OF THE DEVICE IS IN CONTACT WITH THE PATIENT WHEN USING THE DEFIBRILLATOR, THE
TENSION CAN GO THROUGH THE PATIENT’S BODY AND REACH THE SYSTEM. THIS CAN
ENDANGER ANYBODY COMING INTO CONTACT WITH THE SYSTEM AND ALSO DAMAGE THE
EQUIPMENT. ALWAYS REFER TO THE OPERATION INSTRUCTIONS FOR ANY DEFIBRILLATOR
USED ON A PATIENT BEING RADIOGRAPHED WITH THIS DEVICE.

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1.9.4 PROTECTION FROM RADIATION


IT IS NECESSARY TO COMPLY WITH ALL SAFETY PRECAUTIONS AND RADIATIONS PROTECTION
STANDARDS OF EACH SINGLE COUNTRY, SINCE THE RADIATIONS HAVE A HARMFUL EFFECT ON
THE HUMAN BODY.

SINCE THE EQUIPMENT EMITS X-RAYS, IT CAN ENDANGER THE OPERATOR AND THE PATIENT,
IF THE EXPOSURE PARAMETERS ARE NOT RESPECTED.

• During the performance of diagnostic examinations scattered radiations are always


present. For this reason it is absolutely necessary to use an X-ray protection. The
operator is supposed to inquire if the patient is pregnant. Should the presence of a third
person be required, this must also wear the anti-X protection, like the operator and the
patient.
• It is possible to have an additional protection against radiations if using a two-step push-
button connected to the control console by means of an extensible cable, featuring an
extension of about 4 meters.
• Even if this equipment gives a high level of protection against X-rays, no device can
assure a complete protection.
• It is the operator’s task to take all the safety measures required to avoid any personal
and other people’s risk, coming from a wrong or excessive exposure to Ionogenic
radiations.
• All the operators must receive a sufficient training and take the suitable safety measures
to avoid any injury.
• It is highly recommended to use all the different protection devices available on the
market.
• The X-ray beam can go beyond the main protective shielding. Use radiographic cassettes
or digital receptors with leaded support.
• Do not stand behind the receptor or on the X-ray beam line.
• Only the patient can stay in the examination room during the X-ray exposure. If the
operator or another person presence is required, they must wear a leaded apron
according to the safety rules.
• Use the greatest possible distance between the focal spot and the skin to give the patient
the minimum dose.

1.9.5 RESIDUAL RISKS

BMI produce advanced radiographic systems as far as safety and protection of the environment
are concerned. Therefore, if the unit is used correctly, there is no risk to people and environment.
Concerning the risks due to incorrect use of the unit, please refer to the directions and the
recommendations given above. We point out that the unit has been designed to prevent its
overturning up to 10° tilting with respect to the horizontal in transport position.
The following is therefore recommended:

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• Do not stop, do not move and do not park the unit on planes having an inclination
greater than 10°.
• Do not try to move the unit without operating on the special “brakes release” handle
• When displacing the unit is careful if there is any obstacle on the floor (cables, steps,
little drops or rises) concerning the residual risks due to any defect of the adopted
protective measures, we remind you that the protection against electric shocks is realized
through an earth connection of the unit metallic parts.
• It is therefore necessary to check periodically the correct operation of the whole earth
circuit, according to the ordinal maintenance schedule described in this manual.

TO IGNORE AND NOT TO COMPLY WITH THE UNIT ALARMS COULD CAUSE AN OVERHEATING OF
THE X-RAY MONOBLOC. THIS CONDITION COULD RESULT IN THE LOSS OF THE MONOBLOC
INSULATION AND IN DAMAGE TO THE X-RAY TUBE. WHEN MOVING THE UNIT, BE CAREFUL
NOT TO HIT THE PATIENT OR THE OPERATOR. DO NOT MOVE THE UNIT TOO QUICKLY; THE
ACCUMULATED KINETIC ENERGY COULD HAZARD THE PERSONNEL NEXT TO THE EQUIPMENT.

SHOULD ANY ELECTROMAGNETIC INTERFERENCE INFLUENCE THE EQUIPMENT OR BE CAUSED


BY IT, ASK FOR ASSISTANCE. THE PORTABLE RF EQUIPMENT MAY ALTER THE ELECTRO-
MEDICAL EQUIPMENT.

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1.10 ELECTROMAGNETIC COMPATIBILITY (EMC)

This electronic equipment complies with EMC 2014/30/EU Directive, defining the maximum
emission levels allowed for the electronic equipment and the required immunity against
electromagnetic field.
This, however, does not exclude that signals coming from transmitters, like mobile phones or
similar mobile radio transmitters, even if complying with EMC standards, can influence the correct
operation of the Electro medical equipment if used nearby and with a quite high transmitting power. It
is therefore necessary to avoid using these radio transmitters near electronically controlled medical
systems, to exclude any interference.
The electronic unit complying with EMC standards has been designed to avoid any risk of
malfunctioning caused by electromagnetic interferences, when working in standard conditions.
However, the radio signals coming from high frequency transmitters at a quite high transmitting
power, if used near the electronic equipment, may cause electromagnetic incompatibility. Any
transmission with mobile radio transmitter must be avoided.
The mobile phones must be off in the area near the unit. These rules must be complied with
when the unit is working.
In the following pages, please find the EMC Certificate issued by the Italian notified body IMQ.

Manufacturer's declaration - Electromagnetic emissions (table 1)


The Device is designed to operate in the electromagnetic environment outlined below. The customer or
user of the Device should ensure it is used in this environment.
Emission tests Compliance Electromagnetic environment
This group only uses RF energy for internal
RF Emissions operation. As a result the RF emissions are very low
Group 1
CISPR 11 and unlikely to cause any interference in electronic
apparatus nearby.
RF Emissions
Class B
CISPR 11 The Device is suitable for use in all environments,
Harmonic emissions including domestic settings and environments
Class A
IEC 61000-3-2 directly connected to a public low voltage electricity
Voltage supply which powers buildings used for domestic
fluctuations/flicker Compliant purposes.
IEC 61000-3-3

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Manufacturer's declaration - Electromagnetic immunity (table 2)


The Device is designed to operate in the electromagnetic environment outlined below. The customer
or user of the Device should ensure it is used in this environment.
IEC 60601-1-2 test Level of
Immunity tests Electromagnetic environment
level compliance
Electrostatic Flooring must be made of wood,
± 6 kV contact ± 6 kV
discharge (ESD) concrete or ceramic tiles and covered
± 8 kV
± 8 kV air
IEC 61000-4-2 with synthetic material; relative
humidity must be at least 30%.
Transients/seque The quality of the mains supply must
± 2 kV for power ± 2 kV
nces of rapid be similar to that of a typical
supply lines
electric pulses business or health care environment.
± 1 kV for ± 1 kV
IEC 61000-4-4
input/output lines
Overvoltages The quality of the mains supply must
± 1 kV between the ± 1 kV
IEC 61000-4-5 be similar to that of a typical
phases
± 2 kV
business or health care environment.
± 2 kV between the
phase(s) and earth
Voltage dips, The quality of the mains supply must
<5% UT (>95% dip in >95% in 10 ms
short be similar to that of a typical
UT) for a cycle of 0.5
>60% in 100
interruptions and business or health care environment.
40% UT (60% dip in ms
variations in If the user of the Device requires
UT) for a cycle of 5
voltage on power >30% in 500 continuous operation during a mains
supply input 70% UT (30% dip in ms power cut it is advisable for the
lines. UT) for a cycle of 25 Device to be powered from a UPS
>95% in 5000
IEC61000-4-11 system.
5% UT (>95% dip in ms
UT) for 5 s
Magnetic field at The magnetic fields at mains
3A/m 3A/m
mains frequency frequency must be at levels
(50-60Hz) characteristic of a typical business or
IEC61000-4-8 health care environment.
NOTE: UT is the AC mains voltage prior to application of the test level.

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Manufacturer's declaration - Electromagnetic immunity


The Device is designed to operate in the electromagnetic environment outlined below. The customer
or user of the Device should ensure it is used in this environment.
Immunity tests IEC 60601-1-2 test Level of Electromagnetic environment -
level compliance Guide
Irradiated RF 3 Vrms 3 V (V1) Mobile/portable RF communication
IEC 61000-4-3 150 kHz to 80 MHz devices should not be used close to any
part of the Device, cables included, if
nearer than the recommended
separation distance calculated with the
Conducted RF 3 V/m 3 V/m (E1) equation applicable to the transmitter
IEC 61000-4-6 80 MHz to 2.5 GHz frequency.
Recommended separation distance:

Where P is the maximum rated power


output of the transmitter in Watts (W)
according to the transmitter
manufacturer, and d is the
recommended separation distance in
meters (m).
The field intensities of the fixed RF
transmitters determined by
electromagnetic analysis on sitea should
be lower than the compliance level for
each frequency range.b
Interference may transpire in the
vicinity of equipment marked with the

following symbol:
Note 1 At 80 MHz the upper frequency range applies.
Note 2 These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The intensities of fixed transmitters, as well as base stations for telephones (mobiles/cordless), land mobile radios,
amateur radios, AM/FM radio transmissions and TV transmissions cannot in theory be forecast with accuracy. To assess the
electromagnetic environment generated by fixed RF transmitters, an electromagnetic analysis of the site must be considered. If
the intensity of the field measured in the location where the Device is used exceeds the aforementioned applicable level of RF
compliance, the Device should be monitored to check for normal operation. If irregularities in performance transpire, additional
measures may be required, such as moving or changing the position of the Device.
b
In the 150 kHz to 80 MHz frequency range the field intensity must be less than 3 V/m.

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Recommended distances between


mobile RF communication devices and the Device
The Device is designed to operate in an electromagnetic environment in which RF interference is
under control. The customer or user of the Device can help to prevent electromagnetic interference by
ensuring there is a minimum distance between portable/mobile RF communication devices
(transmitters) and the Device, as outlined below in relation to the maximum power output of the radio
communication devices.
Maximum rated From 150 kHz to 80 From 80 MHz to From 800 MHz to
power output of the MHz 800MHz 2.5GHz
transmitter (P)

0.01 0.12 m 0.12 m 0.23 m

0.1 0.37 m 0.37 m 0.74 m

1 1.2 m 1.2 m 2.3 m

10 3.7 m 3.7 m 7.4 m

100 12 m 12 m 23 m

For transmitters specified for a maximum power output not included above, the recommended
distance d in meters (m) can be calculated using the equation for the transmitter frequency, where P
is the maximum rated power output of the transmitter in Watts (W) according to the transmitter
manufacturer.

1.11 DECLARATION OF RESPONSIBILITY


BMI BIOMEDICAL INTERNATIONAL s.r.l. is responsible for the safety of its products only if
their maintenance, repair and/or modification are carried out by its own personnel or by expressly
authorized personnel.
BMI BIOMEDICAL INTERNATIONAL s.r.l. does not assume any responsibility for any
malfunctioning, damage and/or hazard coming from an illegitimate use of the system or non-
compliance with the maintenance standards.
The PERSON RESPONSIBLE for the installation in which the system is working has the task to
make sure that the installation is used only by duly trained and qualified operators.

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CHAPTER 2
UTILIZATION

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2.1 TRANSPORT OF THE EQUIPMENT

e
a
f
b

LEGEND
Rotation direction of the transportation
a
handle to release the brakes
Transport handle for parking brakes (dead-
b
man brakes) control
c Supply cable support
Bracket to lean the unit for overcoming little
d
obstacles
e Arm
f Arm retainer

To displace the equipment the operator must:


• Disconnect the unit supply cable from the socket and wind it on its support (c).
• Put the arm in parking position and make sure that it is correctly hooked to its retainer
(f).
• Push downwards the transport handles (b) to unlock the parking brakes. To move the
equipment keep the handle turned clockwise. The equipment is very handy, thanks to its
low barycentre, its little weight and its pivoting front wheels. Should the operator
accidentally let go the transport handle the provided dead-man mechanical brakes will
immediately stop the unit. To overcome small obstacles easily (like for instance the lift
door), hold tightly the transportation handle pressing your foot on the bracket (d)
available on the rear side of the unit basement. The unit front side will lift, thus
permitting to overcome the obstacle.

This picture shows how


to lift up the Device to
overcome little
obstacles

ATTENTION! DO NOT PUSH THE EQUIPMENT FRONT SIDE AGAINST DOORS TO OPEN THEM.

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2.2 DAILY X-RAY TUBE WARM-UP PROCEDURE

THE IONOGENIC RADIATIONS PRODUCED BY THIS EQUIPMENT CAN BE DANGEROUS TO THE


PATIENT AND THE OPERATOR. STRICTLY COMPLY WITH THE SAFETY RULES IN FORCE.

REMEMBER TO PRE-SET THE LARGE FOCUS FOR ALL RADIOGRAPHIC EXPOSURES AND TO
CLOSE COMPLETELY THE X-RAY COLLIMATOR LEAD BLADES, IN ORDER TO INCREASE THE
SAFETY LEVEL AGAINST IONOGENIC RADIATIONS.

Assumed that this procedure will reduce the possibility of damaging the X-ray tube anode and the
high voltage components in the monobloc, BMI suggest using this procedure when the equipment is
first turned ON for the day, or when it has not been used for more than 24 hours. No test setup is
required.

Perform 6 exposures in the sequence indicated below:

kVp mA ms Nr. of exposures Interval


60 50 500 1 20 seconds
60 50 500 1 20 seconds
80 50 100 1 20 seconds
80 50 100 1 20 seconds
100 25 500 1 20 seconds
100 25 500 1 20 seconds

2.3 X-RAY TUBE FORMATION

This procedure is required only when the Device has not been used continuously for 1 month
after the installation date or if the equipment has not been used continuously for more than 1 month
in the Hospital department.
Forming the monobloc’s X-ray tube prevents it from damages. The X-ray tube formation
procedure consists in making radiographic exposures, according to below reported chart.
For each Device model all the radiographic exposures should be taken using only the X-ray tube
large focus. BMI suggest taking all the radiographic exposures closing the entire X-ray collimator
leaded shutter. The X-ray tube formation procedure will take approximately one hour.

THE IONOGENIC RADIATIONS PRODUCED BY THIS EQUIPMENT CAN BE DANGEROUS TO THE


PATIENT AND THE OPERATOR. STRICTLY COMPLY WITH THE SAFETY RULES IN FORCE.

REMEMBER TO SHUT THE X-RAY COLLIMATOR LEAD BLADES TO INCREASE THE SAFETY LEVEL
AGAINST IONOGENIC RADIATIONS.

Perform some exposures of 500 ms and 25 mA (with a break of 1 minute in between) starting
from 70 kV with increase of 5 kV up to 110 kV.
If during an exposure instability occurs, decrease of 5kV the voltage value and perform two
exposures; then he procedure keeps on.
Wait at least 30 minutes (refer to heating & cooling curves) before performing other exposures.
If no anomalies are found, Device is now ready to be used.

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2.4 EQUIPMENT’S SWITCHING ON

• Connect the equipment supply cable cord plug to the socket.


• Switch ON the equipment through the automatic circuit breaker (the green LED will
indicate the power supply presence).
• Switch ON the Medical Station (refer to Digital Acquisition User Manual).

Green LED – Power Supply

ON (I)

OFF (0)

Automatic circuit breaker

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2.5 ARM POSITIONING


Release the arm retainer and keep hold of the arm using the two available handles to prevent it
from moving.

RELEASE THE ARM STANDING LATERALLY, IN ORDER TO AVOID GETTING HURT.

Arm retainer

Handles

Release the arm, standing laterally Lift the arm using the handles

When the handle is released, the arm will remain in the acquired position thanks to a clutch
device integrated in the equipment.

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2.6 MONOBLOC AND COLLIMATOR DISPLACEMENT

The monobloc with the X-ray collimator assembly can rotate as described below:
• Monobloc yoke support rotation: +90° / -90°
• Monobloc rotation in the yoke: -45° / +167°

To position the monobloc/X-ray collimator assembly, use the handgrip.


The frontal inclination of the monobloc and the X-ray collimator is indicated by the goniometer
placed on the front guard of the monobloc.

Goniometer

Handgrip

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2.7 COLLIMATOR

The Device is supplied with a manual, compact X-ray collimator.


The X-ray field is defined by lead-lined shutters located near the exit window of the X-ray beam
and by a cone (near the focus) limiting the X-ray beam to the larger field size.
The shutters are manually controlled by two knobs available on the collimator front panel.
The X-ray collimator can be rotated ± 90° around its vertical axis, just gripping the handle. The
collimator rotation travel is stopped by a mechanical retainer.
Before making a radiographic exposure set the shutters in the correct position, using the X-ray
field light beam on the anatomic body part to be examined. Comply with the maximum admitted
distance value between the monobloc and the patient’s body.
Additional information can be found in the collimator manual, supplied with the equipment.

2
3

4 4
5
6
7
LEGEND
1. X-ray field light beam pushbutton 6. Retractable tape measure for SID measuring
2. Longitudinal diaphragm adjustment knob 7. Handgrip for ± 90° rotation on its vertical axis
3. Transversal diaphragm adjustment knob 8. Goniometer
4. Rails guides for accessories 9. Monobloc focus external reference point
5. DAP (optional)

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2.7.1 SETTING THE X-RAY FIELD ON THE COLLIMATOR FRONT PANEL

• Press the X-ray field light beam lamp push-button (1) to switch ON the lamp. The lamp
automatically switches OFF after 30 seconds. To avoid the lamp overheating read the
collimator manual.
• Position the collimator/monobloc assembly above the patient.
• Check if the X-ray light beam crosses is centered on the patient’s area to be examined.
• Adjust the X-ray field size using the two knobs available on the front part of the X-ray
collimator (2 and 3). The right knob adjusts the longitudinal shutters; the left one
adjusts the transversal shutters. The knobs make it possible to the operator to set the X-
ray field according to the radiographic cassette size. The collimator field size can vary
from 0×0 cm minimum to 43×43 cm (17”x17”) maximum, at a focus film distance of 100
cm (40”).
• The scale under each knob indicates the longitudinal and transversal field size at 100 cm
(40”) distance.
• Check the SID using the retractable tape measure.

FOR FURTHER TECHNICAL INFORMATION PLEASE REFER TO THE COLLIMATOR MANUAL,


ALWAYS SUPPLIED WITH THE EQUIPMENT.

2.8 RADIOGRAPHIC TECHNIQUES

The equipment microprocessor’s software verifies if the values inserted are compatible
with the equipment monobloc model performances, to avoid any failure.

REFER TO DIGITAL ACQUISITION USER AND SERVICE MANUALS.

2.8.1 DIAGNOSTIC DUMMY PHANTOMS USED

Normally the dummy phantom overall dimensions are 45 cm x 45 cm (PMMA and aluminium
plate).
N. Phantom Structure
1 Abdomen 18 cm PMMA
2 Lumbar spine 18 cm PMMA + 5 mm Al 7x45 at the top and centered
3 Skull 2 cm PMMA + 2 mm Al + 10 cm PMMA + 1 mm Al + 3 cm PMMA
4 Extremity 2 cm PMMA + 2 mm Al + 4 cm PMMA
5 Chest 2 cm PMMA + 2 mm Al + 3 cm PMMA + 5 cm air + 2 cm PMMA + 1 mm
Al + 3 cm PMMA

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2.8.2 WAY OF EXECUTION OF THE TESTS

Collim.
SID

SID

Collim.

2.8.3 MEASURE

SID = Source to Image Distance;


d = Distance between focus and dosimeter
F = Focus: L=Large, S=Small;
Collim. = Collimated surface;
Mdose = dose (mG);
P = Referent distance used to determinate patient’s position;
dose = dose recalculated based on the reference distance of the patient
where the formula is:

SID d Collim Mdose P dose


N. APR Focus kV mAs
[cm] [cm] [cm x cm] [mGy] [cm] [mGy]
1 Abdomen 115 42,5 Large 80 1,6 43x43 0,789 30 0,197
2 Lumbar spine 115 42,5 Large 75 3,2 25x43 1,304 30 0,326
3 Skull 115 42,5 Large 70 4,0 25x25 1,43 30 0,358
4 Extremity 115 42,5 Large 57 1,25 25x30 0,312 30 0,078
5 Chest 135 42,5 Large 120 0,64 43x43 0,689 30 0,113

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2.8.4 TAKING A RADIOGRAPHIC EXPOSURE

• Place the Device collimator on the patient’s area to be exanimate, placing the device
respecting the SID.
• Place the radiographic cassette below the patient’s area to be delaminated.
• Set the collimator X-ray field area (additional information are reported on the device
manual) using its light beam, that allows the operator to obtain on the patient body a
field marker. To switch ON the light beam depress the ON/OFF button, which is located
on the control desk panel and on the collimator itself.
• Adjust the size of the field as described on § 2.7.
• Set the exposure parameters to take the radiography exposure, as described on Digital
Acquisition User Manual.
• Press halfway the preparation button (1st time) in order to spin the X-ray tube rotor.
• Press completely the button (2nd time) in order to take the radiographic exposure.
There will be a warning sound (buzzer sound) to advice the operator that the
radiographic exposure has been taken.

BEFORE TAKING ANY RADIOGRAPHIC EXPOSURE MAKES SURE THAT ALL NECESSARY
PRECAUTIONS AGAINST IONOGENIC RADIATIONS HAVE BEEN TAKEN. AFTER A LONG PERIOD OF
INACTIVITY OF THE EQUIPMENT, IT IS VERY IMPORTANT TO MAKE THE FORMATION OF THE X-
RAY TUBE, TO AVOID ANY H.T. DISCHARGE THAT COULD DAMAGE IT.
THE X-RAY TUBE FORMATION PROCEDURE IS DESCRIBED IN § 2.3.

WHEN THE X-RAY EMISSION IS OVER, THE RELEVANT WARNING LIGHT ON THE CONTROL
CONSOLE DISPLAY GOES OUT AND AT THE SAME TIME THE SOUND SIGNAL STOPS.
AT THIS POINT THE TWO-STEP X-RAY CONTROL PUSH-BUTTON MUST BE RELEASED OR, IF THE
EXPOSURE HAS BEEN CONTROLLED BY THE CONSOLE PUSH-BUTTONS, BOTH OF THEM MUST BE
RELEASED; THE DEVICE IS READY FOR NEXT EXPOSURE

BEFORE TAKING AN X-RAY EXPOSURE PROTECT THE OPERATOR AND THE PATIENT FROM X-RAYS
USING THE SUITABLE LEAD PROTECTIONS.

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2.9 WARNING MESSAGES

In the following table are listed all the errors code that the generator can send to the console.
For each error listed, it is explained its meaning, all the possible situations that can lead to the specific
code and the action that can be done for the resolution of the problem.

ERROR ERROR
PROBLEM (could indicate) ACTION
CODE MESSAGE
Before switching to inactive status (XR0) Reset the error and if
the generator sends the message ‘PR0’ the message persists
18 PR0 Timeout
and does not receive an answer from contact Technical
the console. Support.
Selected parameters caused X-ray tube Wait for the tube to cool
to exceed its programmed anode heat down.
19 Anode Heat Limit
limit. The estimated heating unit is
below the limit.
The received message is not supported Check the wiring
Communication or does not exist. harness of the console.
45 Message Not The console could have sent a wrong If the message persists
Supported message or there could be problems on contact Technical
communication line. Support.
The generator is set to an internal state Verify the protocol rules
in which the received command from (if the console software
Communication console is not allowed. This occurs when is not made from BMI).
46 Message Not the protocol rules are not respected. Change only one
Allowed Simultaneous commands are not command at a time.
allowed i.e. changing kV and prep at the
same time.
The preparation button is pressed Wait till the Initialization
during the Initialization phase. phase is finished.
Check if the led DL3 of
control board is lighted
OFF, after 60 seconds
from unit Power ON. If
Capacitors under
98 the led DL3 does not
charge
light OFF check fuse F1
and F2 of the capacitor
box.
If the message persists
contact Technical
Support.
The temperature surway is opened. Wait for the monobloc
The temperature inside the monobloc is to cool down.
Tube Head Over high. Check the wiring
99
Temperature The cable of the temperature surway is harness.
disconnected. Check the integrity of
the temperature surway.
The OVL alarm signal is still active after Contact Technical
60 second from the by-pass of the line Support.
100 OVL Timeout relays.
The capacitor charging phase has
problem.
The preparation switch has been Repeat the exposure if
1st time PB released too soon in one of the following it’s necessary.
101
released situations: Check switch.
• During the preparation phase

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• During the exposition phase.


Faulty preparation switch.
The exposure switch has been released Repeat the exposure if
2nd time PB
102 too soon during the exposition phase. it’s necessary.
released
Faulty preparation switch. Check switch.
The OK_STARTER signal is not active Re-seat connection to
after 1.5 seconds that the generator the monobloc.
entered in the preparation phase. Check continuity of
Starter contact Poor connection to the monobloc from stator windings.
103
not available the Starter board. Check fuses on Starter
Open stator winding. board.
Faulty Stator board. Check boost voltage.
Replace Starter board.
Before switching to the preparation Reset the error and if
phase the generator send the message the message persists
105 PR1 Timeout
‘PR1’ and does not receive an answer contact Technical
from the console. Support.
Before switching to Ready status the Reset the error and if
generator sent the message ‘PR2’ and the message persists
106 PR2 Timeout
does not receive an answer from the contact Technical
console. Support.
Before switching to Exposure status the Reset the error and if
generator sent the message ‘XR1’ and the message persists
107 XR1 Timeout
does not receive an answer from the contact Technical
console. Support.
Before switching to in Active status the Reset the error and if
generator sent the message ‘XR0’ and the message persists
108 XR0 Timeout
does not receive an answer from the contact Technical
console. Support.
Before entering or during the Exposure Switch the equipment
status (XR1) the OVC alarm signal is off then on again and
active. contact Technical
Monobloc primary inverter current Support if the problem
overload. persist.
Check if the led DL1 of
control board is lighted
ON.
Perform the x-ray tube
formation and check the
mA values. If the result
109 OVC Alarm
of the checking is
negative re-calibrate the
mA.
Check if oil
leakage/spots are
coming out from the
monobloc and the wear
status of the x-ray tube.
If the message persists
contact Technical
Support.
Before entering or during the Exposure Check the led DL3 of the
status (XR1) the OVL alarm signal is control board.
active (this alarm is not notified to Verify fuse F1 and F2
console if the OVC Alarm signal is active (only F1 for 4kW model)
110 OVL Alarm
at the same time) on the capacitor box.
Capacitor box voltage lower than Verify the inverter main
220Vdc. power supply voltage
(Vdc).

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Check the wiring


harness of the feedback
cable on the control
logic board (MR6).
Contact Technical
Support if the problem
persist.
Before entering in the Preparation status Check technique if this
112 Invalid focus (PR1) the tube focus previously selected is seen when APR is
is invalid. used.
This alarm is notified to console if all the Check the led DL2 of the
following conditions are true: filament board, if it’s off
• The generator status is set to exposure than it can be a power
status (XR1). supply missing.
• 100ms after 85% signal. Check fuses on filament
• Preparation switch pressed. board.
• No OVL alarm active. Check the mA accuracy
• No OVC alarm active. during exposure by
113 Min current • During control loop the current read is comparing the mAs
less than the following value: setpoint- meter to the feedback
33%. test point mA. Re-
• mA out of calibration. calibrate if the mA
• Control board out of calibration. ramps down to the
• Tube parameters not configured correct value.
properly. Contact Technical
Support if the problem
persist.
This alarm is notified to console if all the Check the led DL1 of the
following conditions are true: filament board, if it’s ON
• The generator status is set to Exposure switch off the unit and
status (XR1). contact Technical
• 100ms after 85% signal. Support.
• Preparation switch pressed. Check the mA accuracy
• No OVL alarm active. during exposure by
114 Max current • No OVC alarm active. comparing the mAs
• During control loop the current read is meter to the feedback
great than the following value: test point mA.
setpoint+33%. Re-calibrate if the mA
• Control board out of calibration. ramps up to the correct
• Tube parameters not configured value.
properly. Contact Technical
Support.
Within 20ms after the beginning of the Recharge main
Exposure status (XR1) the 85% signal capacitors batteries.
doesn’t become active. Check the correct value
The kV values are below 85% of the set of the tension of the
value. Main storage batteries are low. capacitors.
Check if the led DL1,
DL2 and DL3 of the
control board are lighted
kV values 85% ON.
115
lower Verify fuse F1 and F2
(only F1 for 4kW model)
on the capacitor box.
Check the wiring
harness of the feedback
cable on the control
logic board (MR6).
Contact Technical
Support if the problem

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persist.
The generator internal status is set to Contact Technical
Error status (due to a previous latching Support.
error still not confirmed from console)
116 Wrong context and meanwhile it receives calibration
related message.
This error could be triggered only when
the generator is in setup mode.
The generator tried to go to an Contact Technical
unexpected internal status. This error Support.
118 Out of range shouldn’t occur and could indicate a
corruption of the flash memory or a
software bug.
The generator received a message from Reset the error and if
console with an invalid value. the message persists
119 Invalid value This could be caused by console which contact Technical
doesn’t comply with the supported Support.
version of the protocol.
The correlation of the current set of Reset the error and if
radiologic parameters fails. the message persists
120 Correlation fail
contact Technical
Support.
When potter is enabled and inserted, Check the wiring
the generator waits for the signal harness of the Potter
OK_POTTER while entering or during Bucky.
the Ready status (PR2). Check that the contact
Potter contact not
121 Error is generated if the signal doesn’t of Potter Bucky is
available
become active within 2 seconds from working.
the previous conditions.
The Potter Bucky is not operating
correctly.
The generator cannot operate with the The DAP device is an
DAP. optional contact
This error can be triggered in the technical support for
following situations: enable it.
• The generator receives command to set Check if it is installed in
DAP status and this last has not been the equipment.
122 DAP Not Present activated from setup. Check the wiring
• Timeout on DAP receiver line: the harness.
generator tries to communicate with the
DAP and receives no answer.
• This can occurs if there are
communication problems on DAP serial
line or the DAP is off (not connected).
Should not occurs: if DAP is not enabled Contact Technical
123 DAP Disabled from X-ray mode then the generator will Support.
automatically ignore it.
The received response from DAP is not Contact Technical
valid or unexpected. This kind of error Support.
could be caused by problems on DAP
124 DAP Error
serial line or from an unsupported DAP
version.
The DAP device is not functional.
This error could be triggered when Verify that the Digital
entering and during the Ready status System with external
DR EXP_OK (PR2) if all of the following conditions synchronization work
126
missing are met: properly.
• Exposure button pressed.
• Function DR enabled.

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• EXP_OK signal does not become active


within 5 seconds after the preparation
buttons pressed.
This feature is enabled for a Digital
System with external synchronization.
Before generator enters the Preparation Reset the error and if
status (PR1) and xray usage has not the message persists
been enabled from console. contact Technical
128 XRAY Not Enabled
This error could be triggered if the Support.
console application has not sent the
message ‘XE1’ to generator.
Before generator enters in the Terminate the
Preparation status (PR1) and calibration correctly.
generator/tube calibration has not been Contact Technical
completed. Support if the problem
Calibration status is reset in these persist.
situations:
• Generator/tube configuration is changed
Calibration Not
129 from setup.
Completed
• Inconsistent values in the eeprom
memory.
• Generator is connected to the USB port
for table files upgrade.
• Internal data-flash memory become
corrupted and no table files can be
loaded.
The generator receives a message from Check technique if this
Generator kV
203 console to set new kV value which is is seen when APR is
Limit
beyond the current generator limit. used.
The generator receives a message from Check technique if this
Generator mA
204 console to set new mA value which is is seen when APR is
Limit
beyond the current generator/tube limit. used.
The generator receives a message from Check technique if this
Generator ms
205 console to set new ms value which is is seen when APR is
Limit
beyond the current generator/tube limit used.
The generator receives a message from Check technique if this
Generator mAs
206 console to set new mAs value which is is seen when APR is
Limit
beyond the current generator/tube limit used.
Joule value, computed from the current Contact Technical
set of radiologic parameters, is beyond Support.
the setup joule limit (if set)This error
211 J Limit could be triggered each time a radiologic
parameter is changed.
The requested exposure will exceed the
generator kilo joule energy limit.
Given the current set of radiologic Check technique if this
parameters, both the tube ms focus is seen when APR is
212 Tube limit (large and small) are beyond the limits. used.
This error could be triggered each time
a radiologic parameter is changed.
Given the current set of radiologic For DR acquisition the
parameters, ms value is beyond the users are not enable to
detector limit. use an exposition time
This error could be triggered each time greater than 500 ms.
213 Detector limit a radiologic parameter is changed.
This error could be triggered if the
following conditions are met:
• Function DR enabled.
• Time of exposition great than 500 ms.

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Given the current set of radiologic Check technique if this


parameters, the tube focus selection is is seen when APR is
214 Focus Selection invalid. used.
This error could be triggered each time
a radiologic parameter is changed.
The generator receives a message from Check the wiring
console and printer does not respond to harness.
the request of the generator Check that the printer is
220 Printer timeout
This error can be caused by switched on.
communication problems on printer
serial line or the printer could be off.
The generator receives message of Reference to the printer
221 Printer Error printing from console and printer reports manual.
a generic alarm.
The generator receives message of Contact Technical
222 Printer Disabled printing from the console while the Support for enable the
printer has been disabled from setup printer.
The generator receives message of Reference to the printer
Printer Paper
223 printing from the console and the printer manual.
Sensor fail
reports paper sensor fail alarm.
The generator receives message of Insert the paper.
224 Printer No Paper printing from the console and the printer
reports no paper alarm.
The generator receives message of Reference to the printer
Printer Head
225 printing from the console and the printer manual.
Overtemperature
reports head over temperature alarm.
The generator receives message of Reference to the printer
226 Printer Fault printing from the console and the printer manual.
is not ready or a fault happened.

In general, each timeout error occurs when the generator does not receive the answer
to some specific commands when the connected peripheral (e.g. printer, dap) is not
responding. The timeout period is fixed to 2 seconds. This category of errors can be
caused by problems on communication line, noise or problems on the
console/peripheral side (application crash, out of sync, hardware problems).

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2.10 LANGUAGE

REFER TO DIGITAL ACQUISITION USER AND SERVICE MANUALS.

2.11 DIGITAL RADIOGRAPHIC IMAGE ACQUISITION

The Device are equipped with a digital X-ray imaging system developed by Digitec.
Digitec’s platform is specifically designed for routine radiographic exposures where the image is
captured on a flat panel detector and stored as an electronic patient file in the computer. This
software is a high resolution digital imaging system intended to replace conventional film techniques.
The digital X-ray imaging system enables an operator to acquire, display, process, export images
to portable media, send images over a network for long term storage and distribute hardcopy images
with a laser printer.
Image processing algorithms enable the operator to bring out diagnostic details difficult to see
using conventional imaging techniques. Acquired images are instantly viewable or can be stored
locally for temporary storage.

REFER TO DIGITAL ACQUISITION USER MANUAL FOR THE SOFTWARE USE.

2.12 END OF OPERATION

• Switch OFF the Medical Station.


• Switch OFF the Device by means of automatic circuit breaker.
• Disconnect the supply cable cord from the socket and wind it on its support.
• Position the equipment arm in transport position and hook the arm to the stand by
means of the arm retainer. Park the unit in a suitable and safety place.

DO NOT SWITCH OFF THE EQUIPMENT BY REMOVING THE SUPPLY CABLE FROM THE SOCKET
BEFORE DISCONNECTING THE AUTOMATIC CIRCUIT BREAKER.

AFTER SWITCHING OFF, WAIT AT LEAST 30 SECONDS BEFORE SWITCHING ON THE EQUIPMENT.

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CHAPTER 3
ORDINARY MAINTENANCE

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3.1 GENERAL RECOMMENDATIONS

This chapter is intended for ORDINARY MAINTENANCE only. Regarding EXTRAORDINARY


MAINTENANCE, like failures, malfunctioning or components replacement, please refer to appropriate
chapter.

ORDINARY AND EXTRAORDINARY MAINTENANCE MUST BE CARRIED OUT BY DULY TRAINED


TECHNICAL PERSONNEL AUTHORIZED BY THE MANUFACTURER.

The purpose of this Periodic Maintenance is to guaranty a continue safe performance of the Unit,
to increase serviceability, to reduce costs (down time, repairs, etc.) and to assure the safety (personal
risk).
The equipment requires periodical checking and maintenance to assure correct operation and
safety standards.
Following information and instructions are therefore to be strictly complied with:
• A prolonged utilization of the equipment may affect the system safety due to the quick wear of
the mechanical and electronic components.
• The correct set up of the electronic and mechanical components and of the software can
prevent failures that could affect the safety and the irradiation exposure level to which the
doctors, the paramedics and the patients are exposed.
• The owner of the equipment is responsible for the maintenance correct execution and is
expected to have preventive checking and technical interventions carried out by expressly
authorized technical personnel.

ONLY USE ORIGINAL SPARE PARTS SUPPLIED BY THE MANUFACTURER.

The following checks and maintenance procedures, at the suggested intervals, are the
manufacturer’s recommendation for the most effective Periodic Maintenance schedule for the Unit.
Service tasks here described must be performed exclusively by service personnel specifically
trained on medical X-ray Generators.

3.2 ORDINARY MAINTENANCE

The below reported chart illustrates the scheduled inspections to be carried out:
PERIOD: CHECKING:
NO SPECIFIC • The Flat Panel calibration is usually required in case the user notice some
CYCLE defect or artefact in the x-ray image or change configuration of x-ray system.
It also depends on how frequently the user make exposure with this system,
since x-ray strength could be reduced by usage. Refer to the Digital Acquisition
Service Manual
DAILY • Check the correct functionally of the hand switch remote control.
CHECKING • Check the correct functionally of the collimator.
• Check the wearing status of the supply cable and its plug.
• Check the parking brakes functionality.
• Perform the daily X-ray tube warm-up procedure (see § 2.2).
• Check the wearing status of the flat panel cable and its circular connector.

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• Check the integrity of the flat panel detector frame.


• Check the functionality of the touch screen interfaces on the medical station
(no scrubs, no pen marks).
WEEKLY • Check if during the X-ray emission no noise is coming out from the monobloc.
CHECKING • Check the functioning of the optional installed (e.g. the DAP measuring
chamber).
• Check if the arm retainer works properly (*).
SIX- • Carry out the periodic electric safety tests, according to the local standard in
MONTHLY force.
CHECKING • Check the fastening and the functioning (dust and corrosion) of the electronics
boards.
• Check if there is any dielectric oil leakage coming out from the Monobloc (*).
• Check the X-ray tube wear (*).
• Check the good operation of the equipment’s parking brakes (*).
• Check the alignment of the luminous field with the radiographic field (*).
• Check the balancing of the arm (*).
• Check the balancing of the fork-monobloc assembly (*).
• Check the functionality and appearance of each major component of the
Medical Station. Shutting down the Medical Station:
Clean with a dry soft cloth.
Blow dust from the interior of the PC and from fan covers to permit air
circulation.
Never spray or squirt the liquids directly on the Medical Station.
YEARLY • Check the kV values really emitted during X-ray exposure (*).
CHECKING • Check the mA values really emitted during X-ray exposure (*).
• Check the wearing status of the interface cables between the equipment and
the monobloc.
• Check the wearing status of the frontal and rear wheels.
• Check visually the wearing condition of the steel-clad ropes, their pulleys and
the related mechanical elements.
• Check the integrity of the warning labels.
FIVE-YEARLY • Replace the steel-clad ropes and the mechanical equalizer.
CHECKING • Replace the clutch and the pulleys.
• Replace the front and rear wheels.
Before proceeding to replace one of the above listed components get in contact
with BMI - Service Department, in order to receive the related technical
information together with the spare parts.
YEARLY Check the performance of X-Ray Equipment in compliance with clause 10.4.4 of
CHECKING NOM-229-SSA1-2002 (*).
ONLY FOR
MEXICO

(*) ONLY FOR TECHNICAL PERSONNEL.


SEE DEDICATED PARAGRAPH.

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3.3 CLEANING AND DISINFECTION

Do not use any corrosive or abrasive product or solvent to clean the unit surfaces. To disinfect
the system always comply with the rules in force regarding disinfection procedures and protection
against explosion. For cleaning and disinfection operations, following precautions have to be complied
with:
• Switch OFF the equipment and disconnect the supply cable plug from the socket.
• Be sure that no liquid is poured inside the equipment in order to prevent short circuits and the
corrosion of the electric and electromechanical components.
• Never spray or squirt the liquids directly onto the displays.
• Be cautious of all kinds of cleaning solvents or chemicals when you use it for the sake of
cleaning.
• Some person may be allergic to the ingredients used to prepare the cleaning products.
• Don’t try to put any food, drink or cigarette around the equipment, especially on the monitors.

Keep in mind that some components used to clean the monitors may only be able to be cleaned
using a product designed for cleaning that component, if this is the case it will be mentioned in the
cleaning tips:
• Cloth - A piece of cloth is the best tool to use when rubbing up a component. Although paper
towels or tissues can be used on most hardware as well, we still recommend you to rub it with
a piece of cloth.
• Water or rubbing alcohol – You may moisten a piece of cloth a bit with some water or rubbing
alcohol and rub it on the computer. Unknown solvents may be harmful to the plastics parts.
• Vacuum cleaner - Absorb the dust, dirt, hair, cigarette particles, and other particles out of the
equipment and monitors can be one of the best methods of cleaning a computer. Over time
these items can restrict the airflow in a computer and cause circuitry to corrode.
• Compressed air – not to be used. First, compressed air is extremely forceful, depending also
on its pressure, because compressed air can dislodge particles. These particles are a danger
since they can enter your eyes or abrade skin. The possible damage would depend on the size,
weight, shape, composition, and speed of the particles. Second, compressed air itself is also a
serious hazard. In addition, using air to clean forces the dirt, dust particles and moisture into
the air, making these contaminants.

DO NOT SWITCH ON THE EQUIPMENT WHILE USING ANAESTHETICS, INFLAMMABLE


DISINFECTION AND/OR CLEANING PRODUCT.
IF USING ANY PRODUCT PRODUCING EXPLOSIVE GASEOUS MIXTURE, MAKE SURE THAT THE
GASES DISSIPATE BEFORE SWITCHING ON THE EQUIPMENT AGAIN.

NEVER ATTEMPT TO CLEAN INTERNALLY THE UNIT. THE UNIT MUST BE ALWAYS KEPT SHUT
UNLESS A SPECIFIC RENEWAL PART PROCEDURE IS TO BE UNDERTAKEN BY HIGHLY
QUALIFIED MAINTENANCE PERSONNEL.

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3.4 DISPOSAL

This device is compliant with RoHS2 Directive Recast (Directive 2011/65/EU) related to reduction
of the use of dangerous material on electrical and electronic devices.
Disposal of the device is subject to WEEE Directive Recast (Directive 2012/19/EU), related to
waste generated by electrical and electronic equipment.
As a result, it cannot be treated as domestic waste in the European Union and must be dealt with
by specialist waste disposal companies.

Graphic symbol:

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CHAPTER 4
ELECTRICAL AND ELECTRONIC
COMPONENTS

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4.1 INTRODUCTION

The below reported picture shows the area where are located inside the equipment the main
electrical and electronic components.

Monobloc

Medical Station

Electronic box

Capacitors Inverter

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4.2 PANEL PC

Here below are indicated the operator console external and internal view.

Panel PC

Power Supply
Panel PC

Power Supply
Flat Panel

External view - operator side Internal view - operator side

4.3 ELECTRONIC BOX

Nr. Description Quantity


1 Electronic board «Filament» 1
2 Electronic board «main CPU» 1
3 Electronic board «main Holder» 1
4 Electronic board «Starter » (not present in Model 4 kW) 1
5 Single phase EMI line filter 1
6 Solid state relay 2
7 Ground copper bar 1
8 Socket CN 1 - Capacitors box main power supply 1
9 Main power supply cable 1
10 External X-ray hand switch terminal block 1
11 Automatic single phase circuit breaker 250V 16A 1

4
10

Electronic box - operator side view


5 7 8 3 2

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11

Electronic box - back side view

4.4 INVERTER

Model 4 kW Model 20/30 kW

Equipment back side view

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4.5 CAPACITORS BOX

Quantity
Nr. Description
Model 4 kW Model 20/30 kW
1 Discharge capacitors power charge push button 1 1
2a Fuse 690V 80A 1 0
2b Fuse 140A 660V 0 1
3 Electrolytic capacitor 6800 µF 2 16
4 Rectifier bridge module 1 1
5 Resistance 50W 470R 2 6
6 Toroidal transformer single phase 1500 VA 0 1
7 Panel fuse holder 10x38 0 1
8 Fuse 10x38F 32A 400V 0 1
9 Solid state relay 0 1

Model 4 kW Model 20/30 kW


4 1
5
1 7-8

2
5 b

9
2

3
3

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CHAPTER 5
INSTALLATION

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5.1 INTRODUCTION

The installation of the equipment must be carried out in three phases:


1. Unpacking and verification of the equipment and accessories integrity
2. Electric installation
3. Setting at work

THE EQUIPMENT IS CONFIGURED AND TESTED IN THE FACTORY. SOME ADDITIONAL


ADJUSTMENT COULD HOWEVER BE REQUIRED ON THE SPOT. THE WHOLE PARAMETERS
ADJUSTMENT PROCEDURE IS DESCRIBED IN THE APPROPRIATE CHAPTER.

5.2 UNPACKING

The equipment is wrapped in cellophane and then put inside a wooden or plywood case.
The equipment is secured by means of wooden crosspieces to avoid any movement during the
transport.
On the external side you can find the handling and storing instructions, the shipping address, the
equipment model and serial number.
Any particular request regarding the packing and the labelling must be specified with the order.
The final customer is suggested to ask for special shock watch labels to be applied on the
external side of the packing case. When the customer receives the equipment, if the shock watch
labels have become red, this will mean that the equipment has been incorrectly handled during the
transport or the storing, and has probably been damaged.
For these reasons the customer must accept the equipment on condition, writing “…acceptance
withheld for damaged packing (or similar words)…” on all copies of the transport documents
accompanying the goods. Later the customer will open the case to check the equipment integrity and
will inform the manufacturer about what happened and about the equipment condition.
The customer must inform of:
- Number of shipping document
- Equipment model and serial number.
- He will supply a detailed report with photographs illustrating the packing situation and
the damages and/or malfunctioning of the mechanical, electrical and electronic parts of
the equipment, if any.
- This communication must be sent within 2 days from the date of receipt of the
equipment. After this delay the supplier will not accept any responsibility for damages or
defects caused by the transport.
- Any request of returning the product back will have to be agreed up on with the
manufacturer who must authorize it in writing.

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5.2.1 UNPACKING OF THE EQUIPMENT

EXTERNALLY TO THE DEVICE CRATE BMI STICK ON THE DETAILED PROCEDURE TO CORRECTLY
UNPACK THE EQUIPMENT.

Pay attention to the symbols printed outside the cardboard of the package:

This way up. Keep in a dry place.


Fragile. Don’t use towing devices.

5.3 ELECTRIC INSTALLATION

The Device power supply is 230 Vac single-phase (± 10%) - 50 Hz - 16 A.


The maximum current absorbed by the equipment is indicated both on the equipment label and
on the technical data reported in the manuals supplied with the equipment.

5.4 ELECTRIC INSPECTION

Check visually each cable and each connector installed in the equipment to make sure that there
is no damage that could jeopardize the correct operation of the equipment and the operator’s safety.
Following components must be inspected:
• Equipment supply cable and plug.
• X-ray control cable.
• Equipment/monobloc connecting cable.
• X-ray collimator supply cable.
• DAP interface cable (optional).

5.5 MECHANICAL INSPECTION

Check whether all the main parts of the equipment work properly, to avoid any defect that could
cause malfunctioning or endanger the user or the patient.
The mechanical inspections include the following operations:
• Displacement of the equipment mobile parts in order to verify if the movements occur
smoothly and noiseless.
• Parking brakes testing to check if the equipment braking is quick and efficient.
• Check if there is any break and/or dents and if any screw has become loose thus
jeopardizing the equipment operating and safety conditions.
The main controls are:
• Rolling of the wheels to verify if there is any wrap or damage.
• X-ray equipment parking brake to check if the braking occurs properly.
• Check the integrity of the control console and verify if the touch screen display has no
dents or scratches.

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Integrity and fastening of the guards to verify if all parts screwed to the equipment structure are
firmly fixed. Check the arm balancing to verify that it keeps the required position when lifted (for
example).

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CHAPTER 6
ADJUSTMENTS
& SETUP

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6.1 TOOLS AND TEST EQUIPMENT

The following test equipment is required in Configuration, Calibration and Troubleshooting:


• Oscilloscope
• Non invasive kVp Meter
• Digital Multimeter
• Calculator
• BMI-Console software (installed on Medical Station in administrator profile)

6.2 ADJUSTMENTS

6.2.1 kV VALUE ADJUSTMENT


DO NOT CARRY OUT THE ADJUSTMENT WHEN THE MONOBLOC IS COLD.
REMEMBER TO EFFECT A PREHEATING CYCLE MAKING AT LEAST TWO OR BETTER FIVE
EXPOSURES, PRE-SETTING ON OPERATOR MODE THE MINIMUM mA AND kV VALUES

• Place the non-invasive kilovolmeter instrument on a flat and horizontal surface under
the X-ray collimator.
• Position a Non-Invasive kVp meter aligned to the X-ray beam at SID 50 cm. Open the
light field to center it with the kVp meter.
• Make an exposure (see the next table for the parameters), read the kVp and take
note of the value.
Parameters
Model
kV mA ms
Model 4 kW 100 40 100
Model 20 kW 100 200 100
Model 30 kW 100 200 100

• Verify that the kV value measured by corresponds to the reference value. The
admitted kV measuring allowance is ± 5%.

To eventually adjust the kV value measured, the technician can adjust on the inverter electronic
board «control logic board» the trimmer R117 (for the position see the layout at page 118).

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6.2.2 THE PERFORMANCE OF X – Ray EQUIPMENT (Mexican Standard)

Check the performance of the x-ray tube in compliance with 10.4.4 of Mexican Standard
considering the effective value of HVL dependent of total filtration of the device.
Take radiographic exposures pre-setting the parameters, as written in the below reported charts:

Test performed at Values


SID 1m
kV 80
mA 100
time (ms) 100
mAs 10
Added Al filter No

Normalize the measured value to HVL = 2.3mmAl


Verify the ratio mR/mAs > 7 or µGy/mAs > 70

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6.2.3 mA VALUES ADJUSTMENT

DO NOT CARRY OUT THE ADJUSTMENT WHEN THE MONOBLOC IS COLD.


REMEMBER TO EFFECT A PREHEATING CYCLE MAKING AT LEAST TWO OR BETTER FIVE
EXPOSURES, PRE-SETTING ON OPERATOR MODE THE MINIMUM mA AND kV VALUES.

• Connect the Oscilloscope CH1 between TP18 (mA) and TP1 (GND) on Control logic
board (see page 118).
• Configure CH1 in 1V/div. Time base 20ms/div.
• V and mA relation, measured in the Oscilloscope, is as follows:
mA: 1V = 100 mA (for Model 20/30 kW)
mA: 1V = 20 mA (for Model 4 kW)
• Switch ON the equipment, entering in “operator mode”.
• Take 6 radiographic exposures pre-setting the parameters, according to the Device to
be adjusted, as written in the below reported charts:

Model 4 kW Model 20 kW Model 30 kW


kV mA Exposures time kV mA Exposures time kV mA Exposures time
60 25 100 ms 60 50 100 ms 60 50 100 ms
60 50 100 ms 60 250 100 ms 60 250 100 ms
80 25 100 ms 80 50 100 ms 80 50 100 ms
80 40 100 ms 80 200 100 ms 80 200 100 ms
100 25 100 ms 100 50 100 ms 100 50 100 ms
100 40 100 ms 100 160 100 ms 100 160 100 ms

• For each single radiographic exposure,


Verify that the signal is flat and noiseless and verify that mA value displayed,
corresponds to the reference value (the allowance admitted is ± 10%).
In case of mA value out of the allowance the technician should calibrate the mA
range, as described in § 6.3.9.
For example following there is the measure of the Model 30 kW @ 200mA.

ONLY WHEN THE MONOBLOC HAS BEEN WARMED UP, THE mA VALUES MEASURED SHOULD BE
CONSIDERABLE RELIABLE.

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6.3 CONFIGURATION AND CALIBRATION

Configuration provides the initial settings that must be carried out before starting to work with
the Device. Functionally characteristics of the Device are defined during Configuration.
Calibration data are stored in a memory chip located on the main board.
For enter on the Configuration and Calibration mode the technician must run the BMI-Console
software. This software is installed on the Medical Station on the Administrator profile (refer to the
Digital Acquisition User Manual for understand how to enter in this profile).
The Configuration and Calibration mode is composed by the following pages:

The following pages can be different, depending from the software revision, but the
function is identical.

Menu name Menu mask


Initializing

Password

Data and Time

NOTE: This mask cannot be set


and cannot influence the system
in any way. The real
functionality of this mask, will
be available in the future.

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DAP and Collimator Settings

Language, Generator and Tube

Option and settings

Counters

Calibration kV and Warm Focus

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mA Calibration

NOT ALL THE MASKS AND ALL THE PARAMETERS ARE AVAILABLE. THE PASSWORD’S LEVEL
DEFINE WHAT THE TECHNICIAN CAN MODIFY.

• To navigate between the setup pages press the two arrows icons

Navigator arrows

• Left arrow icon is used to go back in the masks meanwhile the right arrow icon is
used to go forward in the masks.

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6.3.1 HOW TO ENTER IN CONFIGURATION MODE

ONLY TECHNICIAN AUTHORIZED BY BMI ARE ALLOWED TO ENTER IN THE EQUIPMENT SET UP MENU.

To enter in the Configuration mode, proceed as follows:


• Switch ON the equipment (see § 2.4).
• Switch ON the Medical Station and enter like Administrator (refer to the Digital
Acquisition User Manual).
• Run the BMI-Console.

• Press the button on the Initializing mask.

• Type the password (TO BE REQUESTED TO BMI) on the Password mask and then

press the icon , to confirm the data.

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6.3.2 COM PORT SELECTION

“BMI-Console” has a serial communication with the main board. Be sure that the correct COM
port is selected.

• To select the “Com Port”, press the button :

• Select the appropriate Com Port:

• Press the button to confirm the operation.

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6.3.3 DAP AND COLLIMATOR SETTING

This mask allows to enable/disable an eventual DAP and set the time during of the collimator
lamp.

FOR FURTHER TECHNICAL INFORMATION PLEASE CONTACT BMI.

• Enter in Configuration mode (see § 6.3.1).


• Select DAP and Collimator Settings mask, using the navigator arrows.

• Select the time during of the collimator lamp, using the dedicated arrows.
• For enable/disable the DAP option, push on the dedicated button:

A dark gray button means that the respective option is disabled.

A green button means that the respective option is enabled.

A light gray icon means that is not possible to enable/disable the option.
• The buttons are a toggle buttons.
• DAP options are:
Button Description
DAP Enable the function of the optional DAP
Enable Printer Enable the function of the DAP Printer
mGycm2 Enable the function of the unit of measure when the DAP is enable
dGycm2 Enable the function of the unit of measure when the DAP is enable

• The DAP gain is set by the manufacturer when the Device is in under testing.

• To confirm the selection and to exit from Configuration Mode press the icon

and close the BMI-Console with a click on the icon .

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6.3.4 LANGUAGE SELECTION

The English language is pre-set in factory.


• Enter in Configuration mode (see § 6.3.1).
• Select Language, Generator and Tube mask.

• Select the desiderate language using the scrolling icon (A).

• To confirm the selection and to exit from Configuration Mode press the icon

and close the BMI-Console with a click on the icon .

6.3.5 X-RAY TUBE SELECTION

This section only applies after a monobloc replacement with a different X-RAY tube.

THE DEVICE AUTOMATICALLY RESETS THE CALIBRATION PARAMETERS WHEN THIS PROCEDURE
IS STARTED. EVEN IS SET AGAIN THE SAME X-RAY TUBE.

• Enter in Configuration mode (see § 6.3.1).


• Select Language, Generator and Tube mask.

• Select the desiderate X-RAY tube using the scrolling icon (A).
• Proceed with the tube calibration.

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6.3.6 OPTIONS SELECTION

• Enter in Configuration mode (see § 6.3.1).


• Select Option and Settings mask.

A dark gray button means that the respective option is disabled.

A green button means that the respective option is enabled.

A light gray icon means that is not possible to enable/disable the option.
• For enable/disable the desired option push on the respective button. The button is a
toggle button.

• To confirm the selection and to exit from Configuration Mode press the icon

and close the BMI-Console with a click on the icon .

Button Description
D.R. Enable the DR interface
Potter Enable the potter bucky interface
A.E.C. Not Evailable
Enable the X-ray tube anode rotation.
Starter THIS PARAMETER MUST BE ENABLED FOR GENERATOR WITH
ROTATING ANODE TUBE!!!
Real mAs Enable the visualization of the real mAs on the message pop-up
Exposure Out Enable a digital output for indicate the x-ray exposure
Err Auto Ack Enable the automatic alarm acknowledgment
3P Enable/disable the operative mode of 3 points
mAs Visible
When the 3P is enabled, show on the field of mAs the calculation of
this parameter
Enable Scr Enable the function of the screen for the APR
Lamp 1st time
Enable the power ON of the collimator when it’s pressed the
preparation button.
Enable OP Mod Enable/disable the Operator Mode
Enable APR Enable/disable the APR Mode
Enable Login Enable/disable the Login password, when the Device is switched ON

WHEN “ENABLE OP MOD” IS DISABLED, AUTOMATICALLY “ENABLE LOGIN” WILL BE


DISABLED. VICE VERSA WHEN “ENABLE LOGIN” IS ENABLED, “ENABLE OP MOD” IS
AUTOMATICALLY ENABLED.

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6.3.7 COUNTER

This mask visualizes the total and partial numbers of radiographic exposures done and the
heating unit thermal capacity generated by the monobloc. It is possible to reset the partial counters in
case of monobloc replacement.
• Enter in Configuration mode (see § 6.3.1).
• Select Counters mask.

• Press the button for set to zero the desiderated field.

• To confirm the selection and to exit from Configuration Mode press the icon

and close the BMI-Console with a click on the icon .

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6.3.8 CALIBRATION OF kVp GAIN

DO NOT CARRY OUT THE ADJUSTMENT WHEN THE MONOBLOC IS COLD.


REMEMBER TO EFFECT A PREHEATING CYCLE MAKING AT LEAST TWO OR BETTER FIVE
EXPOSURES, PRE-SETTING ON OPERATOR MODE THE MINIMUM mA AND kV VALUES.

• Access to the Control Logic board as described in § 6.4.


• Connect the Digital Multimeter between TP28 (kVp Vref) and TP1 (GND) on Control
logic board (see page 118).
• Enter in Configuration mode (see § 6.3.1).
• Select the Calibration kV and Warm Focus mask.

• Select the field

.
Pressing on it
• Adjust the value displayed in the field (with the two arrows under the field), in order
to measure, with the digital multimeter, 2.05 Vdc
• Select the field

• Adjust the value displayed in the field (with the two arrows under the field), in order
to measure, with the digital multimeter, 5.28 Vdc

«WARM SF CALIB» AND «WARM LF» FIELD PARAMETER IS SET IN FACTORY.


THE DEFAULT VALUE IS 1050.

• To confirm the selection and to exit from Configuration Mode press the icon

and close the BMI-Console with a click on the icon .

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6.3.9 CALIBRATION OF FILAMENT CURRENT (SMALL AND LARGE FOCAL SPOTS)


The mA values calibration is requested only when:
o The Device has been installed on site for the first time.
o Every 12 months as ordinary maintenance.
o The monobloc has been replaced.

DO NOT CARRY OUT THE mA VALUES CALIBRATION WHEN THE MONOBLOC IS COLD.
REMEMBER TO EFFECT A PREHEATING CYCLE MAKING AT LEAST TWO OR BETTER FIVE
EXPOSURES, PRE-SETTING ON OPERATOR MODE THE MINIMUM mA AND KV EXPOSURE
VALUES.

• Access to the Control Logic board as described in § 6.4.


• Connect the Oscilloscope CH1 between TP18 (mA) adn TP1 (GND) on Control logic
board (see page 118).
• Connect the Oscilloscope CH2 between TP19 (kV) adn TP1 (GND) on Control logic
board.
• Configure CH1 in 1V/div and CH2 in 1V/div. Time base 10ms/div.
• kVp and mA relation, measured in the Oscilloscope, is as follows:
kVp: 1V = 20 kV
mA: 1V = 100 mA (for Model 20/30 kW).
mA: 1V = 20 mA (for Model 4 kW).
• Enter in Configuration mode (see § 6.3.1).
• Select the mA calibration mask.

• To set the mA measure number, select the area (a).

• To change the measure number uses the two arrow keys (for decrease the

measure number) (for increase the measure number).

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IN THE mA CALIBRATION MASK THE INITIALS SF AND LF MEANS RESPECTIVELY THE SMALL
AND THE LARGE FOCUS OF THE X-RAY TUBE.

mA AND KVP RANGES DEPEND ON THE DEVICE MODEL. SEE THE FOLLOWING TABLES FOR
KNOW THEM.

Model 4 kW
kV mA
Measure 1 40 25
LARGE FOCUS

Measure 2 40 40
Measure 3 40 63
Measure 4 40 80
Measure 5 40 100
Measure 6 100 25
Measure 7 100 40

Model 20 kW Model 20 kW
kV mA kV mA
Measure 1 60 50 Measure 8 60 25

SMALL FOCUS
LARGE FOCUS

Measure 2 60 100 Measure 9 60 50


Measure 3 60 200 Measure 10 60 100
Measure 4 60 300 Measure 11 60 200
Measure 5 110 50 Measure 12 110 50
Measure 6 110 100 Measure 13 110 100
Measure 7 110 200

Model 30 kW Model 30 kW
kV mA kV mA
Measure 1 60 50 Measure 9 60 25
SMALL FOCUS

Measure 2 60 100 Measure 10 60 50


LARGE FOCUS

Measure 3 60 200 Measure 11 60 100


Measure 4 60 300 Measure 12 60 200
Measure 5 60 350 Measure 13 110 50
Measure 6 110 50 Measure 14 110 100
Measure 7 110 100
Measure 8 110 200

• To confirm the selection press the button .


• Make an exposure and measure kVp and mA signal values with the Oscilloscope
Verify that both signals are flat and noiseless and verify that mA value displayed

on the field , corresponds to the reference value (the allowance


admitted is ± 2%).
If the mA value obtained is not the selected, increase or decrease the filament
current by pressing the arrow icons

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and press the button .


NOTE: The field Status has the following means:
The equipment software does not allow to make any
radiographic exposures. This because after an exposure, in
calibration mode, you need to wait 10 s. Wait before to start
another exposure.
The equipment has made the pause, but the starter board is
not running. Press the X-ray push button 1st time – preparation

The equipment is ready to make an exposure. Press the X-ray


push button 2nd time – exposure for make an x-ray exposure

• Make an exposure again to verify that mA value in the Oscilloscope is the one
selected; if it is not, repeat the procedure to increase or decrease the value.
For example following there is the 7th measure of the Model 4 kW.

CH2: 40 mA

CH1: 100 kV

• Once the correct mA value is reached (take at least two radiographic exposures in
order to verify if the mA value displayed is correct), go on the next step of calibration

• To confirm the selection and to exit from Configuration Mode press the icon

and close the BMI-Console with a click on the icon .

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6.4 CAPACITORS DISCHARGE AND ACCESS TO THE CONTROL LOGIC

DANGER – ELECTROCUTION RISK!


Hazardous voltages exist inside the equipment, even when the main power is
switched off. Approximately 350/450Vdc is the charging voltage of the
capacitors box, according to the Device model.
Failure to comply with all warnings can cause serious injury or death.

• Switch OFF the equipment.


• Disconnect the equipment power supply cord from the socket.
• Remove the protection guard by unscrewing its lateral screws.
Please note that some of them are placed (hided) below the Flat Panel tray.

Protection guard

Hided screws

• Set aside the cassette holder and the screws.


• Discharge the capacitors box keeping continuously pressed (without using a
sharpened tool or anything similar) for at least 100 seconds the red head discharge
push button.

Discharge Push Button

Control logic

KEEP CONTINUOUSLY PRESSED THE DISCHARGE PUSH-BUTTON FOR AT LEAST 100 SECONDS
IN ORDER TO AVOID ELECTRICAL SPARKS IN THE PUSH-BUTTON CONTACT TERMINAL BLOCK.

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CHAPTER 7
EXTRAORDINARY
MAINTENANCE

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7.1 CHECKING OF CORRECT OPERATION OF THE ARM RETAINER

Check whether the hooking system keeps the arm firmly locked and in sequence hook an
unfasten the arm verifying the correct insertion of the hook in its seat. Move the equipment with the
arm locked to verify if it keeps its position. In the negative, replace the “arm retainer assembly”.

7.2 DIELECTRIC OIL LEAKAGE FROM THE MONOBLOC

• Dismount the collimator (see § 7.7.8).


• Switch ON the equipment.
• Switch ON the Medical Station.
• Enter in operative mode (refer to Digital Acquisition User Manual).
• Depress the first time – preparation button in order to light ON the X-ray focus.
• Manually tilt softly the monobloc in the two directions across its rotation axis.
• Look through the monobloc “X-ray windows” verifying if there is/are any air bubble/s
inside the dielectric oil.

“X-ray window”

• Check if there are any dielectric oil spots on the “X-ray window” and on the collimator
plane.
• Reassemble the item previously detached or unwired.
• Make the X-ray field centring (refer to collimator manual).
• If the result of the test is negative, ship to the manufacturer the monobloc to be
repaired or replaced.

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7.3 CHECK THE GOOD OPERATION OF THE PARKING BRAKES

• Switch OFF the equipment and disconnect the equipment power supply cord from the
socket.
• Place the equipment on a flat floor and lock its arm.
• Place a dynamometer in the middle of the column (point of application A).

Point A

• Verify that the equipment with the brakes locked does not move applying a pushing
force of ~220 N [± 5 N].
• Verify that the equipment starts to move with the brakes released applying a pushing
force of ~20 N [± 5 N].
• If the test result is negative, adjust the brakes blocks as indicated in § 7.7.1.

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7.4 CHECK THE ARM BALANCING

• Place the equipment on a flat floor.


• Unlock the arm.
• Position the arm at 90°, parallel to the floor, with the collimator perfectly
perpendicular to the floor.
• Check if the arm, without keeping in position, maintains this position.
• Place the dynamometer below the arm, near the handles, before the fork rotating pin
(application point B).

Point B

• Push with the dynamometer the arm verifying that to lift up is it necessary to apply a
force of ~50 N [± 10 N].
• Place the dynamometer on the arm, near the handles, before the fork rotating pin
(application point C).

Point C

• Push with the dynamometer the arm verifying that to lift down, is it necessary to
apply a force of ~50 N [± 10 N].
• If the test result is negative, adjust the spring as described in § 7.7.3.

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7.5 CHECK THE BALANCING OF THE FORK-MONOBLOC ASSEMBLY

• Place the equipment on a flat floor.


• Unlock the arm.
• Position the arm at 90°, parallel to the floor, with the collimator perfectly
perpendicular to the floor.
• Check using a dynamometer if the force to be applied on the monobloc fork to rotate
it (± 90°) is ~40 N [± 5 N] (application point D).

Point D

• If the test result is negative, adjust the fork joke rotation clutch as described in §
7.7.5.
• Check using a dynamometer if the force to be applied on the collimator’s handle to tilt
the monobloc (-45°/+167°) is ~40 N [± 5 N] (application point E).

Point E

• If the test result is negative, adjust the monobloc rotation clutch as described in §
7.7.6.

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7.6 CHECK THE STEEL-CLAD ROPES CONSUMPTION

• Lift Up the arm.


• Detach the column front guard, unscrewing the related screws, to be set aside then.

Column front guard

Upper housing

Lower housing

• Verify on both two housings, using a torch/lamp, that the pulleys, ropes and
mechanical equaliser does not damage them, prejudicing the equipment safety.
During the inspection move continuously up and down the arm in order to better
evaluates the wearing status of all the mechanical components.
• Reassemble the column front guard.
• Close the arm.

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7.7 MECHANIC ADJUSTMENTS

7.7.1 BRAKE BLOCK ADJUSTMENT

DANGER – ELECTROCUTION RISK!


Hazardous voltages exist inside the equipment, even when the main power is
switched off. Approximately 350/450Vdc is the charging voltage of the
capacitors box, according to the Device model.
Failure to comply with all warnings can cause serious injury or death.

• Switch OFF the equipment.


• Disconnect the equipment power supply cord from the socket.
• Remove the protection guard by unscrewing its lateral screws.
Please note that some of them are placed (hided) below the Flat Panel tray.

Protection guard

Hided screws

• Set aside the cassette holder and the screws.


• Discharge the capacitors box keeping continuously pressed (without using a
sharpened tool or anything similar) for at least 100 seconds the red head discharge
push button.

Discharge Push Button

KEEP CONTINUOUSLY PRESSED THE DISCHARGE PUSH-BUTTON FOR AT LEAST 100 SECONDS
IN ORDER TO AVOID ELECTRICAL SPARKS IN THE PUSH-BUTTON CONTACT TERMINAL BLOCK.

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• Adjust at the same time the brakes stretch acting, half turn per time, on the self-
locking hexagonal nuts (A).

A A
Self locking hexagonal nut:
• To approach the brake to the wheel: screw
both nuts half turn per time.
• To move away the brake from the wheel:
unscrew both nuts half turn per time.

• Grip the transportation handle and release two times the stationary brakes in order to
evaluate if the brakes adjusting has been done correctly.
• Without releasing the stationary brakes, push manually the equipment verifying that it
does not move.
• Verify that each brake sliding block is placed 1 mm away from the wheel.

Brake block
1 mm distance

• Reassemble the cassette holder rear guard.

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7.7.2 UPPER COVER GUARD DETACHING


• Unscrew manually the two black taps, placed on the upper cover guard

Upper cover guard

Black tap

• Loosen the two ring nuts using a pin wrench

Pulling direction to
remove the guard

Ring nuts

• Pull out the column’s upper cover guard as indicated by an arrow in picture

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7.7.3 SPRING ADJUSTMENT

THE ADJUSTMENT OF THE SPRING MUST BE CARRIED OUT ONLY BY TECHNICIANS EXPRESSLY
AUTHORIZED BY THE MANUFACTURER AND DULY TRAINED.
THE GOOD OPERATION OF THE SPRING IS VERY IMPORTANT FOR THE OPERATOR’S AND THE
PATIENT’S SAFETY.

• Close the arm and hook it to its retainer.


• Detach the column’s upper cover guard (see § 7.7.2)
• Loosen at the same time, using two pin wrenches, the left and right ring nuts.

Left ring nut Right ring nut

Clutch sector

• Lift up the arm.


• Detach the column front guard, unscrewing the related screws, to be set aside then,
to reach the spring adjusting housing.

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• Act on the spring adjusting housing, unloosing the two hexagonal nuts (1 and 2).

2
1

• Shifting both the hexagonal nuts to the midcourse of the threaded bar.

Midcourse
Threaded bar
Nuts

• Adjust the collimator height from the floor at 200 cm, using the collimator retractable
meter, as shown on picture.

Keep the monobloc perpendicular to the floor!

Collimator
200 cm

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• When the technician has verified that the F.F.D. is 200 cm, screw both the hexagonal
nuts attached to the “Bumper”.

Nuts

“Bumper”

• Grip both hexagonal nuts to the “Bumper”, keeping hold the lower hexagonal nut and
screw the upper hexagonal nut.

Upper nut
Lower nut

“Bumper”

• This procedure does not allow at the arm losing the maximum’s arm SID position.
• Pull down the arm till reaching 90°. In this position the arm should keep the position
due to a correct spring balancing. In case the arm drops down, increase the spring
traction force, screwing both hexagonal nuts, vice versa reduce the spring traction
force, unscrewing both hexagonal nuts. On the following pictures has been shown the
lower hexagonal nut to be adjusted.

Nuts

• Reassemble the column front guard and the column’s upper cover guard

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7.7.4 ARM CLUTCH ADJUSTMENT

• Close the arm and hook it to its retainer.


• Detach the column’s upper cover guard (see § 7.7.2).
• Loosen at the same time, using two pin wrenches, the left and right ring nuts.

Left ring nut Right ring nut

Clutch sector

• Release the arm from its retainer and displace it at 90°.


• Grip the two ring nuts to increase the clutch force.
• Check that the arm keeps at 90°.
Note: If the arm lifts Up/Down, grip or loosen both ring nuts.
This adjustment should be done being sure that the spring adjustment has been done
(§ 7.7.3).
• Reassemble the column’s upper cover guard.

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7.7.5 FORK JOKE ROTATION CLUTCH ADJUSTMENT

• Detach the cover disk of the rotation pin, unscrewing the central screw, to be set
aside.
Rotation pin

Fork

Cover disk

Fixing screw

M12 nut

• Rotate the monobloc ± 90° around the pin, checking that it keeps in place on both
positions. If it moves, grip the M12 nut.

DO NOT UNSCREW M12 NUT: THE FORK WILL COME OFF TO THE ARM!

• Reassemble the cover disk.

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7.7.6 MONOBLOC ROTATION CLUTCH ADJUSTMENT

• Detach only the monobloc frontal ABS cover guard.


• Tilt the monobloc to check if it keeps the position when it has been left in position.
• If the monobloc does not hold in position, adjust the lateral clutch acting on the ring
nut after having unhook the nut retainer.

Position of the
lateral clutch

Ring nut

Nut retainer

• Reassemble the monobloc front ABS cover guard.

7.7.7 STEEL-CLAD ROPES AND THE MECHANICAL EQUALIZER REPLACEMENT

The pair of steel ropes and the spring equalizing rocker arm have to be replaced every 5 years.
The customer must inform BMI in advance and BMI will authorize the replacement and supply the
spare parts together with the instructions for the replacement.

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7.7.8 COLLIMATOR DISMOUNTING

Remove the X-ray collimator as follows:


• Switch OFF the equipment.
• Lift the equipment arm to the highest position.
• Detach the rear cover (refer to the collimator manual supplied with the equipment)
unscrewing the fastening screw.
• Unwire the collimator lamp power supply wires from the terminal board (please refer
to the collimator manual supplied with the equipment).
• Insulate electrically each collimator lamp power supply wire, in order to prevent short-
circuits.
• Loosen the 4 fixing dowels positioned on the upper side of the collimator (please refer
to the collimator manual supplied with the equipment) keeping the collimator in order
to not to drop down the device.

7.7.9 X-RAY FIELD CENTERING

REFER TO COLLIMATOR MANUAL

7.7.10 COLLIMATOR LAMP REPLACEMENT

REFER TO COLLIMATOR MANUAL

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7.7.11 POWER SUPPLY CABLE REPLACEMENT

• Turn off the mobile unit, using circuit breaker, and remove the plug from the socket.
• Remove the Medical Station by unscrewing the six fixing screws.
• Remove the two profiles and the right carter, by unscrewing the lateral screws.
• Remove the protection guard by unscrewing its lateral screws.
Please note that some of them are placed (hided) below the cassette tray.

Medical Station
Screws

Profiles
Protection guard

• Set aside the cassette holder and the screws.


• Discharge the capacitors box keeping continuously pressed (without using a
sharpened tool or anything similar) for at least 100 seconds the red head discharge
push button.

Discharge Push Button

KEEP CONTINUOUSLY PRESSED THE DISCHARGE PUSH-BUTTON FOR AT LEAST 100 SECONDS
IN ORDER TO AVOID ELECTRICAL SPARKS IN THE PUSH-BUTTON CONTACT TERMINAL BLOCK.

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• Remove the ground wire on the carter by unscrewing the M5 nut.

• Disconnect the ground wire from the copper bar.

• Detach the circuit breaker to facilitate the disconnection of the power supply cable
wires from it.

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• Disconnect the blue (N) and the brown (L) wire from the circuit breaker, as shown in
the picture below.

• Unscrew the cable retainer and remove the power supply cable from the electronic
box.

• Insert a new power supply cable and connect the blue (N) and the brown (L) wire on
the circuit breaker. Mount it on the electronic box in a correct position.
• Secure the power supply cable on electronic box with cable retainer.
• Connect the ground wire on the copper bar by using the screw.
• Connect the other ground wire on the lateral carter, screwing the M5 nut.
• Mount the right carter, the two green profiles and the control console on the unit.

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CHAPTER 8
TROUBLESHOOTING
AND SPARE PARTS

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8.1 TROUBLESHOOTING

The Device contains many self-diagnostic routines which greatly facilitates troubleshooting.
As a general rule, the first step in any troubleshooting procedure is to verify correct power supply
voltage.
The Medical Station will display status messages on the touch screen display during normal and
abnormal operation of the equipment. This paragraph § 2.9 contains tables of those messages and
suggests actions to be taken by service personnel to correct any malfunctions that may occur.

WHENEVER THE DEVICE IS TURNED OFF, WAIT 5 MINUTES BEFORE TURNING IT ON.

BEFORE OPERATING ON THE EQUIPMENT FOR MAINTENANCE IT IS MANDATORY TO DISCHARGE


IN ADVANCE THE CAPACITORS BOX CHARGE. REFER TO § 6.4.

WHENEVER A MONOBLOC OR A FILAMENT ELECTRONIC BOARD OR A MAIN CPU BOARD OR A


CONTROL LOGIC BOARD OR A H.F. INVERTER BOARD IS REPLACED, IT IS NECESSARY TO
PERFORM THE CALIBRATION PROCEDURES.

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8.1.1 LED INDICATORS

The following table describes the normal states and functions of the status and diagnostic LEDs
on the circuit boards in the unit. A change in the state of an LED may be for a brief duration,
especially during a fault or an exposure.

‘Filament board’
LED NORMAL STATE FUNCTION
DL1 OFF If lit, indicates that excessive current has been.
DL2 ON Indicate presence of the power supply.

‘Control board’
LED SILK SCREEN NORMAL STATE FUNCTION
DL1 OFF Over current
DL2 OFF kV Unbalanced
DL3 OFF Over-load
DL4 NOT RAD/FLUORO
DL5 LP/NOT HP (LOW POWER IS HIGH SIGNAL)
DL6 LP/NOT HP (LOW POWER IS HIGH SIGNAL)

‘Main board’
LED SILK SCREEN NORMAL STATE FUNCTION
Indicate presence of
D27 5V ON (GREEN)
the +5Vdc supply
DL9 PREP OFF Lit when in PREP state
DL3 XRAY OFF Lit when in XRAY state
DL5 XRAY OFF Lit when in XRAY state
DL6 XRAY OFF Lit when in XRAY state

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8.2 SPARE PARTS LIST

Should some part of the equipment be replaced BMI suggest using only the original spare parts
in order to avoid any malfunctioning of the equipment and the consequent loss of warranty.
The manufacturer does not assume any responsibility for damages to things or people or to the
equipment caused by the utilization of spare parts that have not been previously approved or
purchased by BMI.
SHOULD YOU NEED ANY SPARE PART, GET IN TOUCH WITH BMI SERVICE DEPARTMENT.
IT IS RECOMMENDED TO COMMUNICATE THE EQUIPMENT SERIAL NUMBER AND MODEL TOGETHER
WITH THE SPARE PART CODE.

MEDICAL STATION
Model
Code Description Model 20 Model 30
Model 4 kW
kW kW
Exposure two-step hand switch
BMHS
complete of extensible cable

ELECTRONIC BOX
Model
Code Description Model 20 Model 30
Model 4 kW
kW kW

E01S027 Main Holder board rev.02

E01S031 Main CPU board rev.02

E12S004 Single phase EMI line filter


Static relay GQ5048D13 50A
E19A001
@ 480V
«filament» electronic board
E01S004
(230Vac Power supply)
«filament» electronic board
E01S011
(115Vac Power supply)
«starter» electronic board
E01S003
(230Vac Power supply)
«starter» electronic board
E01S010
(115Vac Power supply)
Automatic circuit breaker
E19A020
(230Vac Power supply)
Automatic circuit breaker
E19A021
(115Vac Power supply)

CAPACITORS BOX
Model
Code Description Model 4 Model 20 Model 30
kW kW kW

E13A010 Capacitor 6800 µf @ 450V


Static relay GQ5048D13 50A
E19A001
@ 480V
Capacitors box discharge push
E10A001
button YW1B-M1E20R
Toroidal transformer 1500VA
E11S001 single phase. Primary 2x120V
/ Secondary 1x300V.

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Fuse Bussmann BS80 FE 80A


E22A006
690V
Fuse GI138332 - 10×38F gG
E22A004
CH 32A 400V
Fuse Bussmann BSFEE140
E22A003
140A 690V
E20A001 Diode Bridge (800V 35A)

INVERTER & MONOBLOC


Model
Code Description Model 4 Model 20 Model 30
kW kW kW

E01S036 Control logic board R/F

E01S025 Control logic board R/F


BMI H.F. Inverter for fixed
S03S008-02
anode monobloc
BMI H.F. Inverter for rotating
S03S004-02 anode monobloc (230Vac
Power supply)
BMI H.F. Inverter for rotating
S03S017 anode monobloc (115Vac
Power supply)
Monobloc for fixed anode X-
E21A023
ray tube
Monobloc for rotating anode
E21A022
X-ray tube X22
Monobloc for rotating anode
E21A024
X-ray tube KL65

MECHANICS AND VARIOUS


Model
Code Description Model 4 Model 20 Model 30
kW kW kW

M01S007V Monobloc ABS front cover

M01S008V Monobloc ABS rear cover

M01S017V Console ABS cover

M03S104 Silkscreen panel «BMI»

M03S031 Handle – Brake


Rear wheel Ø 250 mm
M02A002 complete of ball bearing (one
piece)
Pivoting antistatic front wheel
M02A003
Ø 80 mm (one piece)
S01S003 Rear brake assembly group
Monobloc - equipment
E23S007
connecting cables
Manual LED collimator model
R104/163E/A
R104/163E/A
Main power supply cord with
E23S104
socket - 6 meters length

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8.3 FUSES LIST

Fuse Board Ampere Volt Type Note


Potter bucky main power supply
F1 Main board 2A 250 V 5×20T
(230 Vac)
Potter bucky main power supply (24
F2 Main board 2A 250 V 5×20T
Vdc)
Collimator lamp main power supply
F3 Main board 6,3 A 250 V 5×20T
(230 Vac)
Electronic board main power supply
F4 Main board 4A 250 V 5×20T
(230 Vac)
Electronic board main power supply
F5 Main board 4A 250 V 5×20T
(230 Vac)
Collimator lamp main power supply
F6 Main board 2A 250 V 5×20T
(24 Vdc)
Transformer TRS1 main power
F1 Driver board 1A 250 V 5×20T
supply (230 Vac)
Electronic board main power supply
F1 Starter board 10 A 250 V 5×20T
(230 Vac)
Electronic board main power supply
F2 Starter board 10 A 250 V 5×20T
(230 Vac)
Electronic board main power supply
F1 Filament board 10 A 250 V 5×20T
(230 Vac)
Electronic board main power supply
F2 Filament board 10 A 250 V 5×20T
(230 Vac)
Inverter main power supply (only for
F1 Capacitor box 80 A 690 V BSFEE80
Model 4 kW)
Inverter main power supply (only for
F1 Capacitor box 140 A 690 V BSFEE140
Model 20/30 kW)
Rectifier bridge (only for Model
F2 Capacitor box 32 A 400 V 10×38F
20/30 kW)

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CHAPTER 9
SCHEMATICS

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9.1 ELECTRONIC BOARD TOPOGRAPHIC LAYOUT

CODE: E01S028
DESCRIPTION: Inverter board (mounted inside the inverter – not available as spare part)

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CODE: E01S025
DESCRIPTION: Control logic board

TP 1 (Gnd)

TP 18

R117

TP 19

TP 28

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CODE: E01S027
DESCRIPTION: Main board

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CODE: E01S004
DESCRIPTION: Filament board

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CODE: E01S003
DESCRIPTION: Starter board

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Electrical diagram Model 4 kW

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Electrical diagram Model 20/30 kW

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9.2 SCHEMATICS

Filament PWBA Monobloc interface PWBA


Terminal block MR3 Terminal block J1
Pin nr. Wire sheath Pin nr. Wire sheath
1 Shield (black) Gnd / Not wired
2 Blue Com J1-3 Blue
3 White Small Focus J1-2 White
4 Brown Large focus J1-1 Brown

Starter PWBA (not Installed on Monobloc interface PWBA


Model 4 kW)
Terminal block MR1 Terminal block J2
Pin nr. Wire sheath Pin nr. Wire sheath
1 Empty | Not used J2-5 Pink/Brown
2 Pink/Brown Com J2-1 White/Grey
3 White/Grey Aux J2-3 Red/Blue
4 Red/Blue Main

Main board Rev. 02 PWBA Monobloc interface PWBA


Terminal block MR14 Terminal block J1
Pin nr. Wire sheath Pin nr. Wire sheath
1 Yellow Thermal switch J1-4 Yellow
2 Green Thermal switch J1-5 Green

Main board Rev. 02 PWBA Collimator


Terminal block MR14 Terminal block M
Pin nr. Wire sheath Pin nr. Wire sheath
3 Yellow Lamp contact M3 Yellow
4 Green Lamp contact M4 Green

Main board Rev. 02 PWBA Collimator


Terminal block MR15 Terminal block M
Pin nr. Wire sheath Pin nr. Wire sheath
1 Brown 24Vac/+24Vdc M1 Brown
2 White 0Vac/0Vdc M2 White

Inverter | Vac Output Monobloc interface PWBA


Feed through insulators Feed through insulators
Ins nr. Wire sheath Ins nr. Wire sheath
1 Red Red/White/Blue/Pink H. T. X Red/White/Blue/Pink
2 Red Brown/Green/Yellow/Grey H. T. Y Brown/Green/Yellow/Grey

Stud Black Gnd Gnd Black


Gnd

Inverter Control Logic PWBA Monobloc interface PWBA


Terminal block MR6 Terminal block J1
Pin nr. Wire sheath Pin nr. Wire sheath
1 Red kV + J1-10 Red
2 Shield (black) Gnd J1-9 Brown/ Shield (black)
3 Blue kV- J1-8 Blue
4 Brown J1-6 White
5 Yellow/Green Gnd|Equipment J1-7 White
6 White mA

DBQ83-EN [Rev. 03] Page 124

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