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Service Manual BV Family R1.

2 Section 1
Technical Data

Section 1 TECHNICAL DATA

Contents

1 TECHNICAL DATA .................................................................................................................................3


1.1 Standards and regulations.......................................................................................................................3
1.2 Specifications...........................................................................................................................................3
1.2.1 Release numbers .................................................................................................................................3
1.2.2 Environmental conditions.....................................................................................................................4
1.2.3 Generator BV Libra / BV Endura..........................................................................................................5
1.2.4 Generator BV Pulsera ..........................................................................................................................6
1.2.5 Accuracy of displays ............................................................................................................................8
1.2.6 Accuracy of dose area product indication (Gycm2) .............................................................................8
1.2.7 Measurement basis for approval tests .................................................................................................8
1.2.8 X-ray tube.............................................................................................................................................9
1.2.9 X-ray tube assembly ..........................................................................................................................13
1.2.10 X-ray source assembly.......................................................................................................................17
1.2.11 Iris Collimator .....................................................................................................................................19
1.2.12 Lead shutters .....................................................................................................................................19
1.2.13 II Dose Rate setting............................................................................................................................20
1.2.14 Dose Rate ..........................................................................................................................................21
1.2.15 Scattered radiation .............................................................................................................................26
1.2.16 Scattered radiation (Isokerma data)...................................................................................................31
1.2.17 Leakage radiation factor ....................................................................................................................38
1.2.18 X-ray tank heating conditions during fluoroscopy operation ..............................................................38
1.2.19 Anode heat storage............................................................................................................................38
1.2.20 Grid.....................................................................................................................................................38
1.2.21 Image intensifier.................................................................................................................................39
1.2.22 TV Camera.........................................................................................................................................39
1.2.23 Monitors .............................................................................................................................................40
1.2.24 Digital processor ................................................................................................................................40
1.2.25 Connectivity data................................................................................................................................41
1.2.26 Power supply......................................................................................................................................42
1.2.27 Battery charge BV Pulsera only .........................................................................................................45
1.2.28 Options & Accessories .......................................................................................................................45
1.3 Dimensions and Weights .......................................................................................................................48
1.3.1 The BV Libra C-arm stand dimensions ..............................................................................................48
1.3.2 Diagrams of BV Libra versions ..........................................................................................................49
1.3.3 The BV Endura C-arm stand dimensions ..........................................................................................52
1.3.4 Diagrams of BV Endura versions.......................................................................................................53
1.3.5 The BV Pulsera C-arm stand dimensions..........................................................................................56
1.3.6 Diagrams of BV Pulsera versions ......................................................................................................57
1.3.7 The BV Pulsera Extended Rotation C-arm stand dimensions ...........................................................60
1.3.8 The BV Family R1.2 Mobile Viewing Station .....................................................................................61
1.3.9 Diagrams of MVS BV Family R1.2 with standard monitor .................................................................61
1.3.10 Diagrams of MVS BV Family R1.2 with XB monitor ..........................................................................62
1.3.11 Diagrams of MVS BV Family R1.2 with LCD monitor ........................................................................62

BV Family R1.2 / Volume 1 (04.0) SM-I 1 - 1


Copyright © 2004 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 1 Service Manual BV Family R1.2
Technical Data

2 MATERIAL SAFETY DATA SHEET.....................................................................................................63


2.1 Sealed Lead Battery ..............................................................................................................................64

3 LOOSE ITEMS ......................................................................................................................................66


3.1 Loose items ...........................................................................................................................................66

4 IDENTIFICATION ..................................................................................................................................67

5 CERTIFIABLE ITEMS ...........................................................................................................................68


5.1 The BV Libra / BV Endura .....................................................................................................................68
5.2 The BV Pulsera......................................................................................................................................69

SM-I 1 - 2 (04.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 1
Technical Data

1 TECHNICAL DATA

1.1 STANDARDS AND REGULATIONS

The BV Family R1.2 Systems, the BV Libra, the BV Endura and the BV Pulsera are developed and
manufactured with observance of a number of directives, regulations and standards. Information regarding the
compliance status with relevant national and international standards, regulations and laws can be obtained –
on request - from your PMS representative or from:

Philips Medical systems


Corporate Technology Department
Building QM 099
P.O. Box 10 000
5680 DA Best
The Netherlands

Fax: +31 40 27 63110

The system conforms to IEC 601-1, class 1, type B, ordinary equipment (enclosed without protection against
ingress of water). The footswitch is watertight equipment (IPX7). In the BV Pulsera, the X-ray source
assembly is splash-proof equipment (IPX4). Mode of operation: continuous operation with intermittent loading
as described in the sections dealing with the generators in the system.

The system is not suitable for use in the presence of a flammable anesthetic mixture.

PMS will make available on request circuit diagrams, component parts list, descriptions, calibration
instructions and any other information which will assist the appropriately qualified technical personnel to repair
those parts of the equipment that have been designated by the manufacturer as repairable.

1.2 SPECIFICATIONS

1.2.1 Release numbers


The release numbers of the systems can be found as follows:
• C-arm stand (CAS)
During initial installation the release number is displayed on the console display at the bottom left-
hand corner.
• Mobile viewing station (MVS)
After start-up, activate the Help function. The release number can be found on every page of the help
menu, at the bottom left-hand corner.

BV Family R1.2 / Volume 1 (04.0) SM-I 1 - 3


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Section 1 Service Manual BV Family R1.2
Technical Data

1.2.2 Environmental conditions

BV Libra / BV Endura - Environmental conditions

Condition Value

Operating temperature 10 to 40 ˚C (maximum permitted range)


10 to 35 ˚C (optimal performance)
Storage temperature -25 to 70˚C
Relative humidity operation 20 – 80 %
Relative humidity storage 5 – 95 % (non condensing)

Air pressure operation & storage 700 / 1100 Hp

Vibration 10 – 150 Hz, 0.35 mm peak

Shock 25 g, 6 ms

BV Pulsera – Environmental conditions

Condition Value

Operating temperature 10 to 40˚C (maximum permitted range)


10 to 35˚C (optimal performance)
Storage temperature -25 to 55˚C short term storage
-25 to 40˚C long term storage
Relative humidity operation 20 – 80 %
Relative humidity storage 5 – 95 % (non condensing)

Air pressure operation & storage 700 / 1100 Hp

Vibration 10 – 150 Hz, 0.35 mm peak

Shock 25 g, 6 ms

SM-I 1 - 4 (04.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 1
Technical Data

1.2.3 Generator BV Libra / BV Endura

BV Libra / BV Endura - Generator

Definition Data

Type HF converter, DC generator


Loading data: Fluoroscopy Focus 0.6 IEC
kV range: 40 to 110 kV
mA range: 0.10 to 7.2 mA
Max. continuous loading 105 s
Average load 200 W up to 30 s on
Average load 150 W up to 60 s on
Loading data: High Definition Focus 0.6 IEC
Fluoroscopy kV range: 40 to 110 kV
mA range: 0.24 to 7.2 mA
Max. loading time 20 s
Average load 100 W up to 110 kV
Average load 150 W up to 80 kV
Loading data: Radiography Focus 1.4 IEC
kV range 40 to 105 kV
Fixed 20 mA
Single load – Average load 150 W
Two loads – Cooling time between exposures 30 s;
- Waiting time for next 2 exposures 62 s
Loading data: Radiography 30 mA
(France) - Max. loading time 320 ms
- Waiting time for next exposures 20 s

BV Libra / BV Endura - Maximum loading factors

Definition Fluoro Rad Rad (France)

Nominal X-ray tube voltage 110 kV 105 kV 105 kV


Highest X-ray tube current 7.2 mA 20 mA 30 mA
Highest electric power 792 W 2100 W 3150 W
Nominal electric power 2000 W (0.1 s, 20 mA, 100 kV)
Lowest current time product 2.0 mAs, (0.1 s, 20 mA, from
40 kV to 105 kV)

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Section 1 Service Manual BV Family R1.2
Technical Data

1.2.4 Generator BV Pulsera

BV Pulsera – Generator

Definition Data

Loading data Fluoroscopy Focus 0.3 / 0.6 IEC


kV range: 40 – 120 kV
mA range: 0.1 – 8.3 mA
Max cont. loading 10 min up to 360 W
Max cont. loading 5 min up to 600 W
Cont. average load 300 W
Loading data HDF Focus 0.3 / 0.6 IEC
kV range: 40 – 120 kV
mA range: 0.24 – 20 mA
Cont. average load 300 W
Loading data Pulsed LDF Focus 0.6 IEC
kV range 40 - 110 kV
mA range 0.4 - 12 mA; average < 6 mA
Frequency 12½ pps
Pulse width 24 or 40 ms
Max. cont loading 10 min. up to 396 W
Max. cont loading 5 min. up to 660 W
Loading data Pulsed Exposure Focus 0.6 IEC
kV range: 40 – 110 kV
mA range: 2 – 60 mA; average < 20 mA
Max frequency 25
Cont. average load 300 W
Loading data Digital Exposure Focus 0.6 IEC
kV range: 40 – 110 kV
mA range: 0.9 – 75 mA
Max loading time 500 ms
Cont. average load 300 W
Loading data Radiography Focus 0.6 IEC
kV range: 40 – 120 kV
mA fixed 60 mA
Max loading time 2 s
Cont. average load 300 W

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Service Manual BV Family R1.2 Section 1
Technical Data

BV Pulsera - Maximum loading factors

Definition Data

Continuous mode LDF


Nominal X-ray tube voltage 120 kV (@ 5 mA)
Highest X-ray tube current 10 mA (@ 110 kV)
Highest electric power 1100 W (110 kV / 10 mA)
Continuous mode HDF
Nominal X-ray tube voltage 120 kV (@ 12 mA)
Highest X-ray tube current 20 mA (@ 72 kV)
Highest electric power 1440 W Isowatt (72 kV / 20 mA to 120 kV / 12 mA)
Audible signal during HDF Yes
Max run time 30 s
Number of runs to max heat capacity 6
X-ray tube current in thermal equilibrium 8.3 mA avg @ 72 kV (30 s on, 42 s off)
Pulsed Fluoroscopy mode
Nominal X-ray tube voltage 110 kV @ 12 mA pk / 6 mA avg
Highest X-ray tube current 12 mA pk / 6 mA avg (@ 110 kV)
Highest electric power 1320 W pk / 660 W avg
Max run time
Pulsed exposure mode
Nominal X-ray tube voltage 110 kV @ 60 mA pk / 20 mA avg
Highest X-ray tube current 60 mA pk / 20 mA avg (@ 110 kV)
Highest electric power 6600 W pk / 2200 W avg
Image storage Always on
Max run time 30 s
Digital exposure mode
Nominal X-ray tube voltage 110 kV (@ 45 mA)
Highest X-ray tube current 75 mA (@ 72 kV)
Highest electric power 5400 W Isowatt (72 kV / 75 mA to 120 kV / 45 mA)
Max loading time < 500 ms
Image storage Always on
Radiography
Nominal X-ray tube voltage 120 kV (@ 60 mA)
Highest X-ray tube current 60 mA (40 – 120 kV)
Highest electric power 7200 W (120 kV / 60 mA)
Nominal electric power 6000 W, 60 mA, 0.1 s (@ 100 kV)
Lowest current time product 3.2 mAs (0.053 s, 60 mA, from 40 – 120 kV)

BV Family R1.2 / Volume 1 (04.0) SM-I 1 - 7


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Section 1 Service Manual BV Family R1.2
Technical Data

1.2.5 Accuracy of displays


Accuracy of displays

Definition Value

Voltage deviation +/- (8 % + 0.8 kV)


Fluoroscopy current deviation +/- (8.5 % + 0.01 mA)
Radiography mAs deviation +/- (10 % + 0.2 mAs)
Dose rate accuracy +/- 25 %

BV Pulsera only:
Digital exposure mAs deviation +/- (15 % mA + 5.0 ms)
Pulse exposure mA avg deviation +/- (15 % mA)

1.2.6 Accuracy of dose area product indication (Gycm2)


Accuracy of dose area product indication (Gycm2)

<30% of max beam diameter >30% of max beam diameter


Below 55 kV +/- 40% +/- 30%
Above 55kV +/- 30% +/- 25%

1.2.7 Measurement basis for approval tests


BV Libra / BV Endura - Measurement basis for approval tests

Definition Value

kV pk Measured using a non invasive kV pk meter placed 30 cm from the focus


Additional filters (1mm Al & 0.1 mm Cu) removed
mA Measured directly in the rectified high voltage circuit
The voltage over the mA feedback resistor was measured on the test points
Time The exposure time measured using a time function in the dose meter
mAs The mAs product calculated using the mA and time results
X-ray output Measured using a dose meter placed in the reference axis of the X-ray beam
Leakage and - Use manual kV control and set to kV max
scattered radiation - Read the displayed mA value and scale the radiation results for the test mA

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Service Manual BV Family R1.2 Section 1
Technical Data

BV Pulsera - Measurement basis for approval tests

Definition Value

kV pk Measured using a non invasive kV pk meter placed 30 cm from the focus


Filter pack (2mm Al, 0.1 mm Cu, 1mm Al) removed and replaced with 2 mm Al
mA Measured directly in the rectified high voltage circuit;
mA jumper P16 was removed and measured with a mA meter
Time The exposure time measured using a time function in the dose meter
mAs The mAs product calculated using the mA and time results
X-ray output Measured using a dose meter placed in the reference axis of the X-ray beam
Leakage and - Use manual kV control and set to kV max
scattered radiation - Read the displayed mA value and scale the radiation results for the test mA

1.2.8 X-ray tube


BV Libra / BV Endura - X-ray tube

Definition Specification

Type Fixed anode


Manufacturer Philips Medical Systems DMC
Model name FO17
Model number 9890 000 64801
Nominal anode input power small focus 0.81 kW
Nominal anode input power large focus 2.1 kW
Maximum anode heat content 35.5 kJ (50.1 kHU)
Maximum continuous heat dissipation 200 W
Maximum heat dissipation 360 W (30.6 kHU/min)
Target material Tungsten
Target angle 12°
Nominal focal spot values 0.6 & 1.4 IEC
Quality equivalent filtration 0.6 mm Al eq.
Nominal X-ray tube voltage 110 kV

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Technical Data

BV Pulsera - X-ray tube

Definition Specification Alternative tube

Type Rotating anode Rotating anode


Manufacturer Varian Inc. Philips Medical Systems
Development and
Manufacturing Centre
Model number A145 RO 0306
Nominal anode input power small focus 6.0 kW 6.0 kW
Nominal anode input power large focus 25 kW 25 kW
Maximum anode heat content 222 kJ (300 kHU) 222 kJ (300 kHU)
Maximum continuous heat dissipation 296 W 296 W
Maximum heat dissipation 870 W (70 kHU/min) 870 W (70 kHU/min)
Target material Rhenium-Tungsten Rhenium-Tungsten
Target angle 10° 10°
Nominal focal spot values 0.3 & 0.6 IEC 0.3 & 0.6 IEC
Quality equivalent filtration 0.5 mm Al eq. 0.5 mm Al eq.
Nominal X-ray tube voltage 120 kV 120 kV
Rotating anode supply Single phase 50 / 60 Hz Single phase 50 / 60 Hz

BV Libra / BV Endura – Single load chart, small focus; c150 W eq. Anode input power

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Technical Data

BV Libra / BV Endura - Single load chart, large focus; 150 W eq. anode input power

BV Pulsera - Single load rating, small focus (40% anode heat content)

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Pulsera - Single load rating, large focus (40% anode heat content)

BV Libra / BV Endura – Anode heating and cooling curve

100

90

80

70
550 W
Heat Capasity (%)

60 300 W
200 W
50 Series4
Series5
Series6
40
COOLING

30

20

10

0
0 1 2 3 4 5 6 7 8 9 10
Time ( min )

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Technical Data

BV Pulsera – Anode heating and cooling curve


100

90

80

70

60 900 W
500 W
HC ( % )

300 W
50
200 W
80 W
40 COOLING

30

20

10

0
0.1 1.0 10.0 100.0
Time ( min )

1.2.9 X-ray tube assembly


BV Libra / BV Endura - X-ray tube assembly

Definition Specification

Manufacturer Philips Medical Systems


Model name HT converter tank
Model number 9890 000 61831
Nominal X-ray tube housing voltage 110 kV
Inherent filtration 2.7 mm Al eq. @ 75 kV
Additional filtration 0.95 mm Al + 0.1 mm Cu
Permanent filtration (IEC 60522) 6.35 mm Al eq. @ 75 kV
Leakage technique factors 110 kV, 200 W

BV Pulsera - X-ray tube assembly

Definition Specification

Manufacturer Gilardoni
Model name iXion monoblock
Model number 102 63300
Nominal X-ray tube housing voltage 120 kV
Inherent filtration 1 mm Al eq. @ 75 kV
Additional filtration 3 mm Al + 0.1 mm Cu
Permanent filtration (IEC 60522) 6.75 mm Al eq. @ 75 kV
Leakage technique factors 120 kV, 300 W

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Libra / BV Endura - X-ray tube emission chart, small focus, Voltage DC

BV Libra / BV Endura - X-ray tube emission chart, large focus, Voltage DC

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Technical Data

BV Libra / BV Endura - X-ray tank emission chart, small focus

BV Libra / BV Endura - X-ray tank emission chart, large focus

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Pulsera – Emission characteristics small focus

20

18

16

14

12
I_tube (mA)

40 kV
10 70 kV
120 kV
8

0
2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8
I_fil (A)

BV Pulsera – emission characteristics large focus

100

90

80

70

60
I_tube (mA)

120 kV
50 70 kV
40 kV
40

30

20

10

0
3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4 4.6 4.8
I_fil (A)

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Technical Data

1.2.10 X-ray source assembly

BV Libra / BV Endura - X-ray source assembly

Definition Values

Maximum X-ray tube assembly heat content 840 kJ (1200 kHU)


Maximum continuous heat dissipation 140 W (11880 HU/min)

BV Pulsera - X-ray source assembly

Definition Value

Maximum X-ray tube assembly heat content 1350 kJ (1900 kHU)


Maximum continuous heat dissipation 192 W (16300 HU/min)

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Libra / BV Endura – Heating and cooling curves

300 W 200 W 150 W


50

100 W
45

40
SURFACE TEMP ( °C )

35

30

25

COOLING
20
0 20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 340 360 380 400 420 440 460 480
TIME ( min )

BV Pulsera – Heating and cooling curves

600 W 400 W 300 W 200 W 150 W


50

100 W

45
SURFACE TEMPERATURE ( °C )

40

35

30

25

COOLING

20
0 20 40 60 80 100 120 140 160 180 200 220 240
TIME ( minutes )

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Technical Data

1.2.11 Iris Collimator

BV Libra / BV Endura - Iris collimator

Definition 6” version 9” version 12” version


BV Libra BV Libra/BV Endura BV Endura
Minimum beam diameter < 5 cm < 5 cm < 5 cm
at II input window (17 cm mode)
Adjustment step less step less step less

BV Pulsera - Iris collimator

Definition 6” version 9” version 12” version

Minimum beam diameter n.a. < 5 cm < 5 cm


at II input window (17 cm mode)
Adjustment n.a. step less step less

1.2.12 Lead shutters

BV Libra / BV Endura - Lead shutters

Definition Value

Width adjustment Down to < 4 cm slit at II


Rotation 360°
Operation Remotely controlled
Shutters 2 independent
Indication on LIH Yes

BV Pulsera - Lead shutters

Definition Value

Width adjustment Down to < 4 cm slit at II


Rotation 360°
Operation Remotely controlled
Shutters 2 independent
Indication on LIH Yes

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Technical Data

1.2.13 II Dose Rate setting

BV Libra / BV Endura – II dose rate setting

Definition 6” version 9” version 12” version

For LDF 300 nGy / s (34 µR / s) 200 nGy / s (23 µR / s) 250 nGy / s (28.6 µR / s)

For HDF 720 nGy / s (82.4 µR / s) 480 nGy / s (55 µR / s) 600 nGy / s (68.7 µR / s)

BV Pulsera – II dose rate setting

Definition 9” version 12” version

For LDF 200 nGy / s (23 µR / s) 250 nGy / s (28.6 µR / s)

For LDF plus 333 nGy / s (38.3 µR / s) 417 nGy / s (47.7 µR / s)

For HDF 480 nGy / s (55 µR / s) 600 nGy / s (68.7 µR / s)

For HDF plus 800 nGy / s (92 µR / s) 1.00 µGy / s (114 µR / s)

For Pulsed Fluoroscopy 480 nGy / s (55 µR / s) - 600 nGy / s (68.7 µR / s) -


800 nGy / s (92 µR / s) 1.00 µGy / s (114 µR / s)

For Pulsed Exposure 800 nGy / s (92 µR / s) – 1.00 µGy / s (114 µR / s) –


1.32 µGy / s (152 µR / s) 1.65 µGy / s (189 µR / s)

For Digital Exposure 1.80 µGy / s (207 µR / s) 2.25 µGy / s (257 µR / s)

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1.2.14 Dose Rate

NOTE

These are the typical dose rates for the BV Family R1.2.
The actual dose rate displayed on the system is calibrated and will be slightly different from the table.
At the maximum kV value, with larger objects the system switches into high penetration mode (HIP) and
increases the mA (and dose) values.
________________

BV Libra dose rate

System 6" (15 cm) 9" (23 cm) 6" and 9"

Object 20 cm H2O 20 cm H2O Max output


kV 71 66 110
Distance from focus 70 cm 70 cm 70 cm
MODE mA uGy/s mA uGy/s mA uGy/s

Cont. LDF (1)(3) 2.75 110.47 2.11 70.1 3.00 389.4


Cont. HDF 6.59 265.14 5.06 168.2 7.20 934.6
INT 1 LDF (3) 0.66 26.51 0.51 16.8 0.72 93.5
INT 1 HDF 1.58 63.63 1.22 40.4 1.73 224.3
½ dose LDF (2)(3) 1.37 55.24 1.05 35.0 1.50 194.7
½ dose HDF 3.30 132.57 2.53 84.1 3.60 467.3
II Formats Size Dose Size Dose

Middle format n.a. n.a. 7" (17 cm) 50% increase


Small format n.a. n.a. 5" (14 cm) 100% increase

Note (1): IEC Normal Dose Mode


Note (2): IEC Low dose Mode
Note (3): LDF HIP Same output as HDF modes

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Technical Data

BV Endura dose rate

System 9" (23 cm) 12" (31 cm) 9" and 12"

Object 20 cm H2O 20 cm H2O Max output


kV 66 67 110
Distance from focus 70 cm 70 cm 70 cm
MODE mA uGy/s mA uGy/s mA uGy/s

Cont. LDF (1)(3) 2.11 70.1 2.27 78.5 3.00 389.4


Cont. HDF 5.06 168.2 5.44 188.4 7.20 934.6
INT 1 LDF (3) 0.51 16.8 0.54 18.8 0.72 93.5
INT 1 HDF 1.22 40.4 1.31 45.2 1.73 224.3
INT 2 LDF (2)(3) 0.97 32.3 1.05 36.2 1.38 179.7
INT 2 HDF 2.34 77.6 2.51 86.9 3.32 431.4
II Formats Size Dose Size Dose

Middle format 7" (17 cm) 50% increase 9" (23 cm) 20% increase
Small format 5" (14 cm) 100% increase 7" (17 cm) 60% increase

Note (1): IEC Normal Dose Mode


Note (2): IEC Low dose Mode
Note (3): LDF HIP Same output as HDF modes

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BV Pulsera dose rate Normal kV/mA curve

System 9" (23 cm) 12" (31 cm) 9" and 12" 9" and 12"

Object 20 cm H2O 20 cm H2O Default maximum Max output


kV 66 67 110 120
Distance from focus 70 cm 70 cm 70 cm 70 cm
MODE – Normal mA uGy/s mA uGy/s mA uGy/s mA uGy/s

Cont. LDF (1) 2.11 71.5 2.27 80.1 3.00 373.4 3.00 448.9
Cont. LDF HIP n.a. n.a. n.a. n.a. 10.00 1244.8 n.a. n.a.
Cont. HDF 5.06 171.7 5.44 192.3 7.20 896.3 7.20 1077.29
Cont. HDF HIP n.a. n.a. n.a. n.a. 12.00 1493.8 n.a. n.a.
INT 1 LDF (3) 0.51 17.2 0.54 19.2 0.72 89.6 0.72 107.7
INT 1 HDF (4) 1.22 41.2 1.31 46.1 1.73 215.1 1.73 258.5
INT 2 LDF (2)(3) 0.97 33.0 1.05 37.0 1.38 172.4 1.38 207.2
INT 2 HDF (4) 2.34 79.2 2.51 88.7 3.32 413.7 3.32 497.2
Pulsed LDF 2.53 85.8 2.72 96.1 3.60 448.1
Pulse 8 ms 3 Hz 1.01 34.3 1.09 38.5 1.44 179.3
Pulse 10 ms 3 Hz 1.27 42.9 1.36 48.1 1.80 224.1
Pulse 13.3 ms 3 Hz 1.68 57.1 1.81 63.9 2.39 298.0
Pulse 8 ms 25 Hz 8.44 286.1 9.07 320.5 12.00 1493.8
Pulse 10 ms 25 Hz 10.55 357.6 11.34 400.6 15.00 1867.2
Pulse 13.3 ms 25 Hz 14.03 475.7 15.08 532.8 19.95 2483.4
MODE – Normal mAs uGy mAs uGy mAs uGy

DIGRAD 140 ms 2.66 90.1 2.86 101.0 3.78 470.5


DIGRAD 300 ms 5.70 193.2 6.13 216.6 8.10 1008.3
DIGRAD 460 ms 8.73 296.1 9.39 331.7 12.42 1546.1
II Formats Size Dose Size Dose

Middle format 7" (17 cm) 50% increase 9" (23 cm) 20% increase
Small format 5" (14 cm) 100% increase 7" (17 cm) 60% increase

Note (1): IEC Normal Dose Mode


Note (2): IEC Low dose Mode
Note (3): INT 1/2 LDF HIP Dose output will increase by a factor 3.33
Note (4): INT 1/2 HDF HIP Dose output will increase by a factor 1.67

Pulse modes: The dose output for 10 ms pulses can be calculated by scaling [i.e. dose for 8 ms x (10 ms/ 8
ms)]. The dose output for other frequencies can be calculated using the actual frequency.

Display 3 5 8 12 25 Hz
Actual frequency 3.125 5 8.333 12.5 25 Hz

Normal Plus mode: Cont. and INT 1/2 LDF and HDF 66.7% dose increase

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BV Pulsera dose rate High Contrast kV/mA curve

System 9" (23 cm) 12" (31 cm) 9" and 12" 9" and 12"

Object 20 cm H2O 20 cm H2O Default maximum Max output


kV 64 64 110 120
Distance from focus 70 cm 70 cm 70 cm 70 cm
MODE – HC mA uGy/s mA uGy/s mA uGy/s mA uGy/s

Cont. LDF (1) 2.99 92.8 2.99 92.8 5.00 622.4 5.00 748.1
Cont. LDF HIP n.a. n.a. n.a. n.a. 10.00 1244.8 n.a. n.a.
Cont. HDF 7.18 222.8 7.18 222.8 12.00 1493.8 12.00 1795.5
INT 1 LDF (3) 0.72 22.3 0.72 22.3 1.20 149.4 1.20 179.5
INT 1 HDF 1.72 53.5 1.72 53.5 2.88 358.5 2.88 430.9
INT 2 LDF (2)(3) 1.38 42.8 1.38 42.8 2.31 287.3 2.31 345.3
INT 2 HDF 3.31 102.8 3.31 102.8 5.54 689.4 5.54 828.7
Pulsed LDF 3.59 111.4 3.59 111.4 6.00 746.9
Pulse 13.3 ms 3 Hz 1.43 44.5 1.43 44.5 2.39 298.0
Pulse 13.3 ms 25 Hz 11.935 370.44 11.935 370.44 19.95 2483.4
MODE – HC mAs uGy mAs uGy mAs uGy

DIGRAD 140 ms 3.77 117.0 3.77 117.0 6.30 784.2


DIGRAD 300 ms 8.07 250.6 8.07 250.6 13.50 1680.5
DIGRAD 460 ms 12.38 384.4 12.38 384.4 20.70 2576.8
II Formats Size Dose Size Dose

Middle format 7" (17 cm) 50% increase 9" (23 cm) 20% increase
Small format 5" (14 cm) 100% increase 7" (17 cm) 60% increase

Note (1): IEC Normal Dose Mode


Note (2): IEC Low dose Mode
Note (3): INT 1/2 LDF HIP Dose output will increase by a factor 2

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BV Pulsera dose rate Isowatt kV/mA curve

System 9" (23 cm) 12" (31 cm) 9" and 12" 9" and 12"

Object 20 cm H2O 20 cm H2O Default maximum Max output


kV 59 60 110 120
Distance from focus 70 cm 70 cm 70 cm 70 cm
MODE – ISO mA uGy/s 70 cm mA uGy/s mA uGy/s mA uGy/s

Cont. LDF 4.53 108.1 4.92 124.4 5.46 679.7 5.00 748.1
Cont. LDF HIP n.a. n.a. n.a. n.a. 10.00 1244.8 n.a. n.a.
Cont. HDF 10.87 259.5 11.80 298.7 13.10 1631.2 12.00 1795.5
INT 1 LDF (1) 1.09 26.0 1.18 29.9 1.31 163.1 1.20 179.5
INT 1 HDF 2.61 62.3 2.83 71.7 3.14 391.5 2.88 430.9
INT 2 LDF (1) 2.09 49.9 2.27 57.4 2.52 313.7 2.31 345.3
INT 2 HDF 5.02 119.8 5.45 137.8 6.05 752.9 5.54 828.7
MODE – ISO mAs uGy mAs uGy mAs uGy

DIGRAD 140 ms 5.71 136.2 6.19 156.8 6.88 856.4


DIGRAD 300 ms 12.23 292.1 13.28 336.2 14.70 1835.1
DIGRAD 460 ms 18.75 447.7 20.35 515.2 22.60 2813.8
II Formats Size Dose Size Dose

Middle format 7" (17 cm) 50% increase 9" (23 cm) 20% increase
Small format 5" (14 cm) 100% increase 7" (17 cm) 60% increase

Note (1): IEC Normal Dose Mode


Note (2): IEC Low dose Mode
Note (3): INT 1/2 LDF HIP Dose output will increase by a factor 1.83

The Interventional reference point is intended to be representative of the point of intersection of the X-ray
beam axis and the patient. For this type of system normal use for interventional procedures is with the c-arm
vertical or horizontal and patient as close as possible to the II.
The Interventional reference point is 30 cm from the image intensifier entrance surface or 69.5 cm from the
focal spot. [ref. IEC 60601-2-43]

The error in estimating the total absorbed dose to the skin introduced from the defined point should average
out as long as the procedure is composed of multiple views. Even under the worst-case conditions, errors
should be less than a factor of two. Of course, assessing the position of the patient and calculating the
appropriate correction factor can eliminate most of this error. [ref. IEC 60601-2-43]

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1.2.15 Scattered radiation

The following diagrams show the distribution of scattered radiation in the vicinity of the C-arm stand.

Scattered radiation diagram for BV Libra with 6” II:

200

190

180

170

160

150

140

130
4
25cm

120

3 110
2
100
1
90

80

70

60

50
1 = 5 milli Gy/hr
40 2 = 2 milli Gy/hr
3 = 1 milli Gy/hr
30
BV LIBRA 6" 4 = 0,5 milli Gy/hr
20

10
110kV 200W
37440010

20 30 40 50 60 70 80 90 100

X = distance in cm
Y = distance in cm

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Scattered radiation diagram for BV Libra / BV Endura with 9” II:

200

190

180

170

160
5
150

140
4
130
3
25cm

120
2
110
1
100

90

80

70

60
1 = 10 milli Gy/hr
50
2 = 5 milli Gy/hr
40 3 = 2 milli Gy/hr
4 = 1 milli Gy/hr
30
BV ENDURA 9" 5 = 0,5 milli Gy/hr
20

10
110kV 200W
36260134

20 30 40 50 60 70 80 90 100

X = distance in cm
Y = distance in cm

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Scattered radiation diagram for BV Endura with 12” II:

200

190

180

170

160

150

140
5
130

120
25cm

4
110
3
100
2
90
1
80

70

60
1 = 20 milli Gy/hr
50
2 = 10 milli Gy/hr
40 3 = 5 milli Gy/hr
4 = 2 milli Gy/hr
30
BV ENDURA 12" 5 = 1 milli Gy/hr
20

10
110kV 200W
36260131

20 30 40 50 60 70 80 90 100

X = distance in cm
Y = distance in cm

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Scattered radiation diagram for BV Pulsera with 9” II:

200

190

180

170

160

150

140

130

120
25cm

110
1 2 3 4 5
100

90

80

70

60

50 1 = 20 milli Gy/hr

40 2 = 10 milli Gy/hr
3 = 5 milli Gy/hr
BV PULSERA 9" 30
4 = 2 milli Gy/hr
20 5 = 1 milli Gy/hr

10
120kV 300W
36260133

20 30 40 50 60 70 80 90 100

X = distance in cm
Y = distance in cm

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Scattered radiation diagram for BV Pulsera with 12” II:

200

190

180

170

160

150

140

130

120
25cm

110
1 2 3 4 5
100

90

80

70

60

50 1 = 40 milli Gy/hr

40 2 = 20 milli Gy/hr
3 = 10 milli Gy/hr
BV PULSERA 12" 30
4 = 5 milli Gy/hr
20 5 = 2,5 milli Gy/hr

10
36260132

120kV 300W

20 30 40 50 60 70 80 90 100

X = distance in cm
Y = distance in cm

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1.2.16 Scattered radiation (Isokerma data)

Measurement conditions

The tests were made using the maximum X-ray beam for the size of the system.
A 25 cm cube PMMA phantom was placed 5 cm in front of the II input surface. The entrance plane of the
phantom was therefore at the interventional reference point 30 cm in front of the II.
The results are normalized to 1 (uGy/s) / (uGym²/s). The following table provides details of:
• Dose area product at the interventional reference point.
• Actual dose rate for a normalized value of 0.01 (uGy/s) / (uGym²/s).

The table height was set to 87.5 cm, meaning that the centre of the phantom was at a height of 1 meter above
the floor. The degree of uncertainty regarding the results is < ± 50%.

System Nominal X-ray tube Dose area product Dose rate [nGy/s]
voltage [kV] [uGym2/s]
BV Libra 6” 110 3.1 31.0
BV Endura & BV Libra 9” 110 7.0 70.4
BV Endura 12” 110 12.7 127.0
BV Pulsera 9” 120 8.1 80.8
BV Pulsera 12” 120 14.6 146.0

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The following figures illustrate the measuring conditions for each system. Measurements were made in the
horizontal position and in the lateral position.

Measurement configuration diagram Horizontal position

Measurement configuration diagram Lateral position

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Isokerma maps for BV Libra (6 inch II)


Horizontal position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

Lateral position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

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Isokerma maps for BV Libra & BV Endura (9 inch II)


Horizontal position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

Lateral position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

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Isokerma maps for BV Endura (12 inch II)


Horizontal position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

Lateral position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

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Isokerma maps for BV Pulsera (9 inch II)


Horizontal position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

Lateral position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

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Isokerma maps for BV Pulsera (12 inch II)


Horizontal position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

Lateral position

Isokerma map at 1.0 m and 1.5 m height (uGy/s)/(uGym²/s)

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1.2.17 Leakage radiation factor

With an average load of 200 W at 110 kV for the BV Libra / BV Endura and 300 W at 120 kV for the BV
Pulsera, the leakage radiation does not exceed 873 nGy/h (100mR/h) at 1 meter from the focal spot.

1.2.18 X-ray tank heating conditions during fluoroscopy operation

BV Libra / BV Endura - X-ray tank surface temperature indication

Message Temperature of tank surface

None Tank oil temperature is within working range


X-ray tank warm Approx. 44 °C
X-ray tank very warm Approx. 48 °C
X-ray tank disabled – tank too warm Approx. 50 °C

BV Pulsera - X-ray tank surface temperature indication

Message Temperature of tank surface

None Tank oil temperature is within working range


X-ray tank warm Approx. 44 °C
X-ray tank very warm Approx. 48 °C
X-ray tank disabled – tank too warm Approx. 50 °C

1.2.19 Anode heat storage

The anode heat storage capacity is monitored in such a way that successive high-definition fluoroscopy
loading or radiography exposures cannot overload the anode.

1.2.20 Grid

Grid

Definition Specification

Type Circular
Material Carbon fiber
Lines / cm 60 / cm
FFD 100 cm
Ratio 1:10

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1.2.21 Image intensifier

Image Intensifier

Definition 6” II 9” II 12” II

Type Single mode Triple mode Triple mode


Entrance field sizes 15 cm / 6 inch 23 – 17 – 14 cm / 31 – 23 – 17 cm /
9 – 7 – 5 inch 12 – 9 – 7 inch
BV Libra x x
BV Endura x x
BV Pulsera x x
Input screen Csl Csl CsI

1.2.22 TV Camera

TV camera

Definition Specification

Type High resolution CCD sensor with BV view image brightness regulation
Lines (interlaced) 625 at 50 Hz
Pre-processing ADC and AGC
Video standards CCIR (50 Hz)
Image rotation Continuous ± 200° (with pre-indication on screen)
Optics High quality lenses with anamorphic optics

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1.2.23 Monitors

Standard Monitors

Definition Specification
Type High resolution anti reflection / anti static screen (MPR II)
Size 43 cm / 17 “
Scan frequency 75 / 90 Hz Non-interlaced
Brightness control Automatic

High-end Monitors (optional)

Definition Specification
Type High contrast, high resolution triple gun / anti static screen (MPR II)
Size 43 cm / 17 “
Scan frequency 75 / 90 Hz Non-interlaced
Brightness control Automatic

LCD Monitors (optional)

Definition Specification
Type SXGA active matrix monochrome TFT / LCD
Size 46 cm / 18 “
Display matrix 1280 * 1024
Brightness control Automatic

1.2.24 Digital processor

Digital processor

Definition Specification

Display matrix 1008 x 560 x 8


Type Dedicated 12 bit video pipeline processor with real-time
processing and overlay
Disk storage capacity 50 – 500 – 1000 images (depending on commercial option)
(BV Libra)
Disk storage capacity 500 – 5000 – 10000 images (depending on commercial option)
(BV Endura / BV Pulsera)
Maximum storage speed 50 images disk; up to 3 images / s
(BV Libra) 500 images disk; up to 3 images / s
1000 images disk; up to 5 images / s
Maximum storage speed 500 images disk; up to 5 images / s
(BV Endura / BV Pulsera) 5000 images disk; up to 8 images / s
10000 images disk; up to 25 images / s
Processing options Subtraction – Road mapping - Trace black
(BV Libra zoom, measure and Trace white
subtraction only) Zoom - Measure
Real-time pixel shift – Land marking

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1.2.25 Connectivity data

Connectivity DICOM workflow interface

System Specification

DICOM workflow interface Optional


Network protocol Ethernet TCP / IP network using DICOM v3.0 protocol
Network medium 10 BaseT, 100 BaseT

Connectivity data Video output (DFI), 50 Hz

Definition 50 Hz

Horizontal frequency 15.625 kHz


Horizontal front porch 1.50 ms
Horizontal sync width 4.70 ms
Horizontal blanking 12.0 ms
Vertical frequency frame 25 Hz
Vertical frequency field 50 Hz
Vertical front porch 2.5 lines
Vertical sync width 2.5 lines
Vertical blanking (field) 25 lines
Pixel aspect ratio 1.37
Pixel clock frequency 20.25 MHz
Pixels / line 1296
Lines / image 575
Interlaced Yes
External pixel clock available No
Pre equal pls 5
Post equal pls 5
Separating pls Yes

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1.2.26 Power supply


Power supply

Definition Specification

Voltage 100, 110, 120, 130, 200, 210, 220, 230 or 240 V
Configuration Single phase (power / neutral, separate earth)
Frequency 50 or 60 Hz
Max frequency deviation +/- 1 Hz

Wall outlet sockets must be provided with a proper ground connection accepting grounding cord plugs. Mains
plug must be Hospital grade in the USA and Canada. In other countries, the plug must be approved for use in
this application by the relevant local safety regulations.

The resistance in the socket must conform as follows:

BV Libra / BV Endura – Mains supply requirements

Definition Values Values (Fluoro only)

100 V
Current LT / mom 15 / 40 A (max 4 s) 15 / 20 A (max 20 s)
Max impedance 0.1 Ω 0.2 Ω
Mains voltage tolerance ± 10 % ± 10 %
Mains fuse Slow Slow
Definition Values Values (Fluoro only)

120 / 130 V
Current LT / mom 15 / 40 A (max 4 s) 15 / 20 A (max 20 s)
Max impedance 0.12 Ω 0.24 Ω
Mains voltage tolerance ± 10 % ± 10 %
Mains fuse Slow Slow
Mains plug (USA only) NEMA 5-20P NEMA 5-15P
Definition Values Values (Fluoro only)

230 V
Current LT / mom 10 / 25 A (max 4 s) Not applicable
Max impedance 0.6 Ω Not applicable
Mains voltage tolerance ± 10 % Not applicable
Mains fuse 16 A slow Not applicable

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BV Libra / BV Endura mains specification

Mains supply Standby LDF HDF RAD Units


100 / 130 V 7 15 20 40 A
200 / 240 V 5 10 15 25 A
100 / 240 V 800 1200 1900 3500 W
100 / 240 V 950 1400 2200 4500 VA

NOTE

The measured values will not exceed the specified values by more than 10% (UL 2601). Mains current values
in large text are as quoted on the system labels. BV Libra and BV Endura – LDF/HDF/RAD values for max.
output. BV Pulsera LDF/HDF/RAD values for 110 kV and max. mA. BV Pulsera ‘Stator’ acceleration time 0.3
or 0.9 seconds.
________________

BV Pulsera – Mains supply requirements

Definition Values

100 V
Current LT / mom 10 / 20 A (max 1 s)
Max impedance 0.1 or 0.2 Ω
Mains voltage tolerance +10 / -8 % or +10 / -6 %
Mains fuse Slow
Definition Values

120 / 130 V
Current LT / mom 10 / 20 A (max 1 s)
Max impedance 0.18 or 0.24 Ω
Mains voltage tolerance ± 10 % or +10 / -9 %
Mains fuse Slow
Mains plug (USA only) NEMA 5-15P
Definition Values

230 V
Current LT / mom 6 / 10 A (max 1 s)
Max impedance 0.6 Ω
Mains voltage tolerance ± 10 %
Mains fuse 16 A slow

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BV Pulsera mains specification

Mains supply Standby STATOR LDF HDF RAD Units

100 / 130 V 8 20 10 10 10 A
200 / 240 V 5 10 6 6 6 A
100 / 240 V 800 200 900 900 900 W
100 / 240 V 850 2200 1100 1100 1100 VA
Total Heat dissipation 800 200 1440 2400 9000 W

NOTE

The measured values will not exceed the specified values by more than 10% (UL 2601). Mains current values
in large text are as quoted on the system labels. BV Libra and BV Endura – LDF/HDF/RAD values for max.
output. BV Pulsera LDF/HDF/RAD values for 110 kV and max. mA. BV Pulsera ‘Stator’ acceleration time 0.3
or 0.9 seconds.
________________

BV Pulsera – 100 V and 120 V mains Supply requirements

0.900
EXAMPLE:
Ri = 0.400 Vmains >= 120 V - 6.6 %
0.800
Ri = 0.240 Vmains >= 120 V - 9.1 %
Ri = 0.300 Vmains >= 120 V - 8.2 %
0.700 Ri = 0.180 Vmains >= 120 V - 10 %

0.600

0.500

0.400

0.300

0.200
EXAMPLE:
Ri = 0.100 Vmains >= 100 V - 8.0 %
0.100
Ri = 0.200 Vmains >= 100 V - 6.0 %
Ri = 0.300 Vmains >= 100 V - 4.0 %
0.000
0 1 2 3 4 5 6 7 8 9 10

A dedicated AC power line is recommended to avoid conflicts with the power requirements of other
equipment. When mains impedance is such that the momentary voltage drop is too large, a dedicated mains
circuit has to be used, with requirements for the minimal voltage.

For the USA the momentary voltage drop on a normal mains circuit is 4% at rated current. Most other
countries have similar regulations. The local authorities or the Philips representative has to be consulted for
more details on mains requirements.

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1.2.27 Battery charge BV Pulsera only


The following graph shows the time it takes to re-charge a battery for the BV Pulsera.

BV Pulsera – Battery charging time

100

90

80

70

60
% CHARGE

50

40

30

20

10

0
0 1 2 3 4 5 6
TIME ( HOURS )

1.2.28 Options & Accessories


BV Family R1.2 – Options

DICOM workflow interface Specifications

Network protocol Ethernet TCP/IP network using DICOM v3.0 protocol


Network medium 10BaseT, 100BaseT
DICOM conformance Modality work list management (SCU)
Image storage (SCU)
Basic grey scale print (SCU)
MPPS (SCU)
Storage Commit (SCU)
Exam based export Yes

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BV Family R1.2 – Options

DFI Featuring

Extended processing Electronic blanking, Zoom and pan, Measure


Vascular functions Subtraction
Trace black (BV Endura / BV Pulsera)
Roadmap (BV Endura / BV Pulsera)
Remasking
Pixelshift (BV Endura / BV Pulsera)
Landmarking (BV Endura / BV Pulsera)
Extended vascular functions Trace white (CO2)
(BV Endura / BV Pulsera)
Cardiac Pulsed Functions Cardio 8 ms
(BV Pulsera) Cardio 10 ms
Cardio 13 ms
Image storage
BV Endura / BV Pulsera Capacity 500 – 5000 – 10000 images
BV Libra Capacity 50 – 500 – 1000 images

BV Family R1.2 – Options

Laser positioning tools Specifications

Laser aiming device Installed on image intensifier;


Output power:
- IEC class 3a
- FDA class II
Wavelength 670 nm
Alignment accuracy < 0.3% of SID in vertical beam point projection
Point projection
Laser alignment tool Integrated in X-ray assembly;
Output power:
- IEC class 3a
- FDA class II
Wavelength 670 nm
Alignment accuracy < 0.3% of SID in vertical beam point projection
Cross hair projection on installed target cross plate with lead cross hair

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Technical Data

BV Family R1.2 – Options

Other options Specifications

Spacers -20 cm SSD


-30 cm SSD
System lock Key switch to enable/disable radiation and/or height
(Standard) movement
VCR Refer to VCR User manual for specifications
VCDR Refer to VCDR User manual for specifications
Printer Manufacturer: Sony
Type: UP-960
Media: paper
Manufacturer: Sony
Type: UP-980
Media: paper & transparency

BV Family R1.2 - Accessories

Accessories Description

Sterile covers (3x) Tank unit


Image intensifier
C-arm
Springbow To install sterile cover C-arm
Cassette holder 6” Type universal cassette holder cassette format
(not for USA) 24x24 IEC 60406 or
24x30 IEC 60406
Cassette holder 9” Type universal cassette holder cassette format
24x24 IEC 60406 or
24x30 IEC 60406
Cassette holder 12” Type universal cassette holder cassette format
24x24 IEC 60406 or
24x30 IEC 60406

WARNING

Only the options and equipment delivered by PMS may be used in conjunction with the systems. The use of
accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a
reduced level of safety in the resulting system. Consideration relating to the choice shall include : 1 – use of
the accessory in the patient vicinity; 2 – evidence that the safety certification of the accessory has been
performed in accordance with the appropriate IEC 60601 – 1 and/or IEC 60601 – 1 – 1 harmonized national
standards.
________________

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Section 1 Service Manual BV Family R1.2
Technical Data

1.3 DIMENSIONS AND WEIGHTS

1.3.1 The BV Libra C-arm stand dimensions

BV Libra C-arm stand movement specification.

BV Libra - C-arm stand specifications geometry

Definition Specification

Longitudinal travel 20 cm
Panning movement ± 10°
Motorized height movement 49 cm (range from +41 to –8 cm)
Rotation Beyond ± 180° with safety stop at ± 135°
Angulation +90° / -25°
Source image distance Fluoroscopy 99.5 cm
Radiography with cassette holder 94.5 cm
Source skin distance 20 cm (optional 30 cm for USA)
Distance from image intensifier screen to 78 cm
X-ray tube output window
Distance from C-arm to X-ray beam 61 cm
Weight 6” 260 kg
Weight 9” 260 kg

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Service Manual BV Family R1.2 Section 1
Technical Data

1.3.2 Diagrams of BV Libra versions

The following diagrams show the geometry of the 6” and the 9” versions of the BV Libra respectively. The
dimensions of both systems are indicated on all diagrams.

BV Libra 6” front view:

BV Libra 6” side view:

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Libra 6” top view:

BV Libra 9” front view:

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Service Manual BV Family R1.2 Section 1
Technical Data

BV Libra 9” side view:

BV Libra 9” top view:

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Section 1 Service Manual BV Family R1.2
Technical Data

1.3.3 The BV Endura C-arm stand dimensions

BV Endura C-arm stand movement specification.

BV Endura - C-arm stand specifications geometry

Definition Specification

Longitudinal travel 20 cm
Panning movement ± 10°
Motorized height movement 49 cm (range from +43 to –6 cm)
Rotation Beyond ± 180° with safety stop at ± 135°
Angulation +90° / -25°
Source image distance Fluoroscopy 99.5 cm
Radiography with cassette holder 94.5 cm
Source skin distance 20 cm (optional 30 cm for USA)
Distance from image intensifier screen to 78 cm
X-ray tube output window
Distance from C-arm to X-ray beam 61 cm
Weight 9” 280 kg
Weight 12” 295 kg

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Service Manual BV Family R1.2 Section 1
Technical Data

1.3.4 Diagrams of BV Endura versions

The following diagrams show the geometry of the 9” and the 12” versions of the BV Endura respectively. The
dimensions of both systems are indicated on all diagrams.

BV Endura 9” front view:

with classic wheel base with ultra compact wheel base


360
°

MIN. 1750
MAX. 2240

800

880

BV Endura 9” side view:

with classic wheel base25 with ultra compact wheel base


25°° or 45° for extended rotation (45° for extended rotation)
° 0
9

200

430

1685
60

990

MIN. 1840
MAX. 2040

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Endura 9” top view:

with classic wheel base (measures in cm) with ultra compact wheel base

BV Endura 12” front view:


0
with classic wheel base with ultra compact wheel base
36
°

MIN. 1750
MAX. 2240

800

880

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Service Manual BV Family R1.2 Section 1
Technical Data

BV Endura 12” side view:

with classic wheel base25 with ultra compact wheel base


25°° or 45° for extended rotation (45° for extended rotation)
° 0
9

200

430

1745
60

990

MIN. 1840
MAX. 2040

BV Endura 12” top view:

with classic wheel base (measures in cm) with ultra compact wheel base

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Section 1 Service Manual BV Family R1.2
Technical Data

1.3.5 The BV Pulsera C-arm stand dimensions

The BV Pulsera C-arm stand movement specification

BV Pulsera - C-arm stand specifications geometry

Definition Specification

Longitudinal travel 20 cm
Panning movement ± 10°
Motorized height movement 49 cm (range from +43 to –6 cm)
Rotation Beyond ± 180° with safety stop at ± 135°
Angulation +90° / -25°
Source image distance Fluoroscopy 99.5 cm
Radiography with cassette holder 94.5 cm
Source skin distance 20 cm (optional 30 cm for USA)
Distance from image intensifier screen to 78 cm
X-ray tube output window
Distance from C-arm to X-ray beam 61 cm
Weight 9” 305 kg
Weight 12” 310 kg

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Service Manual BV Family R1.2 Section 1
Technical Data

1.3.6 Diagrams of BV Pulsera versions

The following diagrams show the geometry of the 9” and the 12” versions of the BV Pulsera respectively. The
dimensions of both systems are indicated on all diagrams.

BV Pulsera 9” front view:

with classic wheel base with ultra compact wheel base


360
°

MIN. 1805
MAX. 2295

800

880

BV Pulsera 9” side view:

with classic wheel base 25 with ultra compact wheel base


25° °or 45° for extended rotation (45° for extended rotation)
° 0
9

200

430

1740
60

990

MIN. 1930
MAX. 2130

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Section 1 Service Manual BV Family R1.2
Technical Data

BV Pulsera 9” top view:

with classic wheel base (measures in cm) with ultra compact wheel base
66

10˚ 10˚

BV Pulsera 12” front view:

with classic wheel base with ultra compact wheel base


360
°

MIN. 1805
MAX. 2295

800

880

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Service Manual BV Family R1.2 Section 1
Technical Data

BV Pulsera 12” side view:

with classic wheel base25 with ultra compact wheel base


25°°or 45° for extended rotation (45° for extended rotation)

° 0
9

200

430

1735
60

990

MIN. 1930
MAX. 2130

BV Pulsera 12” top view:

with classic wheel base (measures in cm) with ultra compact wheel base
66

10˚ 10˚

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Section 1 Service Manual BV Family R1.2
Technical Data

1.3.7 The BV Pulsera Extended Rotation C-arm stand dimensions

The BV Pulsera Extended Rotation C-arm movement specification

BV Pulsera Extended Rotation C-arm stand specifications geometry

Definition Specification

Longitudinal travel 20 cm
Panning movement ± 10°
Motorized height movement 49 cm (range from +41 to –8 cm)
Rotation Beyond ± 180° with safety stop at ± 135°
Angulation +90° / -45°
Source image distance Fluoroscopy 99.5 cm
Radiography with cassette holder 94.5 cm
Source skin distance 20 cm (optional 30 cm for USA)
Distance from image intensifier screen to 78 cm
X-ray tube output window
Distance from C-arm to X-ray beam 61 cm
Weight 9” 295 kg
Weight 12” 305 kg

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Technical Data

1.3.8 The BV Family R1.2 Mobile Viewing Station

The MVS movement specification.

MVS specifications

Definition Specification

Weight (with standard monitors) 210 kg


Weight (with High-end monitors) 220 kg
Weight (with LCD monitors) 210 kg
Video paper / transparency printer (option) 9 kg
Video cassette recorder (option) 7 kg
Video Compact Disc Recorder (option) 5 kg

1.3.9 Diagrams of MVS BV Family R1.2 with standard monitor

BV Family R1.2 – MVS side and front view with standard monitor

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Section 1 Service Manual BV Family R1.2
Technical Data

1.3.10 Diagrams of MVS BV Family R1.2 with XB monitor

BV Family R1.2 – MVS side and front view with High-end monitor

1.3.11 Diagrams of MVS BV Family R1.2 with LCD monitor

BV Family R1.2 – MVS side and front view with LCD monitor

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Service Manual BV Family R1.2 Section 1
Technical Data

2 MATERIAL SAFETY DATA SHEET

CAUTION

The supplier has issued the data on the following pages. The information and recommendations are believed
to be accurate. However no guarantee or warranty, expressed or implied, is made.
________________

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Section 1 Service Manual BV Family R1.2
Technical Data

2.1 SEALED LEAD BATTERY

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Technical Data

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Section 1 Service Manual BV Family R1.2
Technical Data

3 LOOSE ITEMS

3.1 LOOSE ITEMS

The following devices are delivered separately as loose items:

− Equipotential conductor and mounting material


− Footswitch
− Spare consumables; Cable deflectors; Fuses; (box)

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Service Manual BV Family R1.2 Section 1
Technical Data

4 IDENTIFICATION

The type number plates are located on the PEI units. The location of the PEI number plates and labels is
given in the appropriate PEI documentation. A central information plate is located on the C-arm stand. The
presence of the label plate is indicated by the ‘I’ symbol on the rear C-arm cover.

Identification of the BV Family R1.2 System by serial number

Identification of system by serial number

EP* BV Libra 6” version Fixed anode


EQ* BV Libra 9” version Fixed anode
ER* BV Endura 9” version Fixed anode
ES* BV Endura 12” version Fixed anode
ET* BV Pulsera 9” version Rotating anode
EU* BV Pulsera 12” version Rotating anode

*) relevant part of serial number

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Section 1 Service Manual BV Family R1.2
Technical Data

5 CERTIFIABLE ITEMS

5.1 THE BV LIBRA / BV ENDURA

The BV Libra / BV Endura is compatible with the following certifiable components:

Component type Model designation Labeling

X-ray Control Stand fixed anode Central


(BV Libra) 9896 001 92221/2
X-ray Control Stand fixed anode Central
(BV Endura) 9896 001 92201/2
Tube Housing Assy HT converter tank Central
Refer to unit manual
Beam Limiting Device Collimator Central
Refer to unit manual
Image intensifier 15 cm II tube assy Central
(BV Libra) 9896 010 23651
or
Image Intensifier 23 cm II tube assy Central
9896 010 23661
or
Image Intensifier 30 cm GG BB Sur Central
(BV Endura) 9896 010 23581
Spotfilm Device 9” cassette holder Local
Refer to unit manual
Spotfilm Device 12” cassette holder Local
(BV Endura) Refer to unit manual
Television Receiver MD0709BRM Local
9896 010 02992
or
Television Receiver MMM17AB Local
9896 010 02961
X-ray Control XTV-8 HPA TV camera Central
Refer to unit manual
Laser Product Laser aiming device Local
9896 000 07261
Laser Product Laser alignment tool Central
9896 010 00652
Laser Product MP 3000 Local
9896 000 05871 (50Hz)

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Technical Data

5.2 THE BV PULSERA

The BV Pulsera is compatible with the following certifiable components:

Component type Model designation Labeling

X-ray Control Stand rotating anode Central


(BV Pulsera) 9896 001 92211/2
Tube Housing Assy iXion Monoblock Central
Refer to unit manual
X-ray Generator iXion HF generator Central
Refer to unit manual
Beam Limiting Device Collimator Central
Refer to unit manual
Image Intensifier 23 cm II tube assy Central
9896 010 23661
or
Image Intensifier 30 cm GG BB Sur Central
9896 010 23581
Spotfilm Device 9” cassette holder Local
Refer to unit manual
Spotfilm Device 12” cassette holder Local
Refer to unit manual
Television Receiver MD0709BRM Local
9896 010 02992
or
Television Receiver MMM17AB Local
9896 010 02961
X-ray Control XTV-8 HPA TV camera Central
Refer to unit manual
Laser Product Laser aiming device Local
9896 000 07261
Laser Product Laser alignment tool Central
9896 010 00652
Laser Product MP 3000 Local
9896 000 05871 (50Hz)

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Service Manual BV Family R1.2 Section 2
Order config & Delivery sheet

Section 2 ORDER CONFIG & DELIVERY SHEET

Contents

1. INTRODUCTION .....................................................................................................................................2

2. ORDER CONFIGURATION & DELIVERY SHEET.................................................................................2

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Section 2 Service Manual BV Family R1.2
Order config & Delivery sheet

1. INTRODUCTION

In this Section the Trace list and the Packing list have to be filed.

2. ORDER CONFIGURATION & DELIVERY SHEET

To be delivered upon order

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Service Manual BV Family R1.2 Section 3
Unpacking instructions

Section 3 UNPACKING INSTRUCTIONS

Contents

1. UNPACKING INSTRUCTIONS ...............................................................................................................2


1.1. Unpacking time ........................................................................................................................................2
1.2. Tools ........................................................................................................................................................2
1.3. Transportation..........................................................................................................................................2
1.4. Documents...............................................................................................................................................2
1.5. Transportation tools .................................................................................................................................2

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Section 3 Service Manual BV Family R1.2
Unpacking instructions

1. UNPACKING INSTRUCTIONS

This Section contains instructions for unpacking, transportation and mounting. The unpacking instructions
are also delivered with the shipping packing.

There are 3 alternative ways in which the BV Family R1.2 System can be packed:
1. The CAS and the MVS are wrapped in plastic foil;
2. The CAS and the MVS are packed in separate (re-usable) crates;
3. The CAS and the MVS are either packed in a single disposable crate;

NOTE

The re-usable crates must be returned. For details of the packing and shipping procedures, refer to the
information inside the crates;
________________

1.1. UNPACKING TIME

The time needed to unpack a BV Family R1.2 System is:


- Re-usable crates: 0.5 hr, 1 FSE
- Disposable crates: 1 hr, 1 FSE

1.2. TOOLS

Disposable crates: electric screwdriver, standard toolkit


Others: standard toolkit

1.3. TRANSPORTATION

For transportation through the hospital building;

The dimensions of the CAS and the MVS must be observed when using elevators or going through doors.
Refer to the Section “Technical Data” for more information about dimensions & weight.

1.4. DOCUMENTS

The service documentation is delivered with the BV Family R1.2 System(s).

1.5. TRANSPORTATION TOOLS

The packed system has to be transported with a dedicated forklift to move the pallets towards its
destination(s).
This could be transportation to and in ports, warehouses and user owned buildings.

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Service Manual BV Family R1.2 Section 4
Installation instructions

Section 4 INSTALLATION INSTRUCTIONS

Contents

1 INTRODUCTION .....................................................................................................................................2
1.1 Installation activities .................................................................................................................................2
1.2 Required tools & test equipment..............................................................................................................2
1.2.1 Service PC ...........................................................................................................................................2
1.2.2 Other tools & test equipment................................................................................................................2

2 OVERVIEW OF ON-SITE ACTIVITIES...................................................................................................3

3 SITE SURVEY REPORT .........................................................................................................................4


3.1 Relevant aspects .....................................................................................................................................4
3.2 Site survey report format .........................................................................................................................4
3.3 DICOM workflow interface xa questionnaire ...........................................................................................5
3.3.1 Purpose of this Questionnaire..............................................................................................................5
3.3.2 Explanation of the questions in the questionnaire below.....................................................................5
3.3.3 DICOM Workflow Questionnaire ..........................................................................................................7

4 ON-SITE INSTALLATION.....................................................................................................................12
4.1 Check on power supply requirements ...................................................................................................12
4.1.1 Site mains voltage & frequency check ...............................................................................................12
4.1.2 Mains voltage adaptation ...................................................................................................................13
4.1.3 Mains voltage programming...............................................................................................................13
4.1.4 Check on hardware programming of MCU ........................................................................................14
4.2 Installation of relevant options ...............................................................................................................14
4.3 Connection of cabling & earthing...........................................................................................................14
4.3.1 Cabling instructions............................................................................................................................14
4.3.2 Cabling diagram .................................................................................................................................15
4.4 Check on hardware programming sub-systems ....................................................................................15
4.4.1 Check on hardware programming BV Libra / BV Endura generator unit..........................................15
4.4.2 Switching ON......................................................................................................................................15

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Section 4 Service Manual BV Family R1.2
Installation instructions

1 INTRODUCTION

1.1 INSTALLATION ACTIVITIES

The total installation activities will take not more than a working day.

NOTE

X-ray systems have to be configured initially by qualified experts [factory]; the [restricted number of] experts
are trained and do have a professional qualification to work with X-ray devices. FSEs have a level 2
authorization not allowing initial system configuration. The various authority levels have been can be
found in SM-G section 2.
________________

NOTE

The factory obtained test results, of which the data are incorporated in the Service Manual under the Section
“Record of Measured Data”. These data should always be kept and used as on-site reference values.
________________

1.2 REQUIRED TOOLS & TEST EQUIPMENT

1.2.1 Service PC

The installation of the service PC software has been described in SM-SW section 1. The service PC should
have been installed before the commissioning of the system.

1.2.2 Other tools & test equipment

To perform a complete commissioning program, there are no other standard tools and/or test equipment
required.

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Service Manual BV Family R1.2 Section 4
Installation instructions

2 OVERVIEW OF ON-SITE ACTIVITIES

The following flowchart details the activities and handing over of the BV Libra / BV Endura and
BV Pulsera release 1.2 systems.

Program the
generator
frequency of the
system

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Section 4 Service Manual BV Family R1.2
Installation instructions

3 SITE SURVEY REPORT

3.1 RELEVANT ASPECTS

With respect to the on-site installation of the BV Family R1.2 Systems, these systems are relatively easy to
commission because no particular site measures are required, apart from the specific earthing requirements.
To avoid unnecessary confusion it is recommended to carry out a site survey, before the factory assembly of
the system, focusing on eventual power supply requirements. If the option of the DICOM workflow interface is
ordered, also the questionnaire has to be filled in.

The relevant aspects of the power supply are:


1. Voltage
2. Frequency
3. Plug specification

The actual data has to be gathered and reported via a Site Survey Report to (or through) the PMS SSD/SSR
organization for onward transmission to the Philips Medical Systems Nederland marketing department.
A format to report the actual data has been incorporated in this chapter.

The relevant data of the DICOM Workflow Interface should be reported via the questionnaire. This format is
also available in this Service Manual.

3.2 SITE SURVEY REPORT FORMAT

The site survey report will be part of the contractual documents and should be filed and archived together with
the other relevant documents in Section “Record of measured data”.

A (possible) format for the site survey report is the one used by PMS marketing.

NOTE

The Site Survey Report form has to be filled in for each room where the system will be used.
________________

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Service Manual BV Family R1.2 Section 4
Installation instructions

3.3 DICOM WORKFLOW INTERFACE XA QUESTIONNAIRE

The DICOM workflow interface questionnaire is also part of the Site Survey Report and should be filled in and
sent to the PMS SSD/SSR organization for onward transmission to the PMS Marketing department.

NOTE

The DICOM workflow interface questionnaire has to be attached to the Site Survey Report.
________________

3.3.1 Purpose of this Questionnaire

To assure seamless introduction of the BV Family to the hospital network, the Philips Service engineer must
have specific information before installation.
Where:
1. The local sales representative should give this questionnaire to the hospital network administrator.
2. The questionnaire responds should be faxed to the local sales representative
3. The local sales representative is responsible for making the information available to the right persons
within the local organization!

The local sales representative should make the requested information available to the service
engineer.

Providing this information in the way described above will ensure optimal preparation and a smooth
installation procedure.

NOTE

Installation can only take place and be successful if the questionnaire is completely filled out and signed
before installation!
________________

3.3.2 Explanation of the questions in the questionnaire below


3.3.2.1 Hospital information

• Name, address, etc.


Necessary for identification purposes.

• Is a Network available?
If not, it is no use trying to sell a DICOM Workflow Interface to this customer. The only thing you can do is
asking if we can help.

• Type of Network.
Tells the service engineer if special precautions are necessary.

• Hospital Network Administrator.


He or she is your most important partner in communication regarding the DICOM connectivity. (Try to get
a second name, just in case!).

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Section 4 Service Manual BV Family R1.2
Installation instructions

3.3.2.2 Modality information

The BV Family system should be connected to the DICOM network. Information about the modality is
necessary to configure the BV Family as a DICOM modality.

3.3.2.3 Worklist server and MPPS info

This information is only needed if a Worklist Server (RIS/HIS) either with or without an MPPS Server will be
used.
• AE title and an IP address and port number should be made available by the hospital.
• AE title in MWL in the Query set.
The Patient/Procedures on the Worklist Server are primarily assigned to a certain modality (default OT).
They can be made specific for a certain System by including the (Scheduled) Modality AE title in the
query set.
• Unique identification.
• Only one identifier will be used by the BV Family system to uniquely identify the patient entries in the
DFI's 'Patient Administration' list. All other parameters will automatically be updated in case they are
changed on the RIS/HIS system.

Standard the Accession number will be used for this identification. The Scheduled Procedure Step ID or the
Procedure ID can also be used. Contact the PMS helpdesk.

3.3.2.4 Target devices information

This list describes all the target devices (workstations, printers, PC, PACS etc) that should be connected with
our BV Family system.
Target name, AE title, IP address and port number for the target system should be made available by the
hospital!

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Service Manual BV Family R1.2 Section 4
Installation instructions

3.3.3 DICOM Workflow Questionnaire


3.3.3.1 Hospital Information:

a. Name ................................................................................................................................ :

Address ................................................................................................................................ :

Tel ................................................................................................................................

Fax ................................................................................................................................

E-mail ................................................................................................................................

Mains Power supply


50 Hz
60 Hz

b. Is there a Network available?

Yes
No

Is the Network an Ethernet?

Yes
No

What is the speed of the network card?

10 Mbps
100 Mbps
other speed

Is the connector a RJ45 type?

Yes
No: connector type: ...............................................................................................................

c. Hospital Network Administrator:

Name ................................................................................................................................

Tel ................................................................................................................................

Fax ................................................................................................................................

E-mail ................................................................................................................................

Second hospital network administrator or assistant

Name ................................................................................................................................
Tel ................................................................................................................................
Fax ................................................................................................................................
E-mail ................................................................................................................................

BV Family R1.2 / Volume 1 (04.0) SM-I 4 - 7


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Section 4 Service Manual BV Family R1.2
Installation instructions

3.3.3.2 Modality Information

a. BV Family system information (to be filled in by Philips)

System software release ...................................................................................

b. BV Family System information

IP address . . .

Subnet mask 255.255.255.0

Default Gateway (IP address) (see note 1) ...................................................................................

Station Name (see note 2) BV Family

AE Title BV_Family_AE

Port number for Export, Print, MPPS, WLM 104 (fixed)

Port number for Storage Commit 8104 (fixed)

c. Service PC IP address (see note 3) ...................................................................................

Note: 1
Default gateway to be used when accessing targets outside the subnet (if applicable to be obtained from the
network administrator).

Note: 2
These are default values. In case of more then one BV Family system connected to the same network,
different values, for each system, have to be chosen for the station name.

Note: 3
An IP address for the Service PC is only needed if the Service PC will be connected to the network. If service
will be performed via a serial cable, an IP address is not necessary.

3.3.3.3 Workflow server and MPPS information

This information is only needed in case of a Worklist Server (RIS/HIS) either with or without a MPPS Server.

Worklist server Information (WLM)

Manufacturer ...........................................................................................................

Model ........................................................................................................... :

Version ........................................................................................................... :

Name ........................................................................................................... :

AE Title ........................................................................................................... :

IP address ...........................................................................................................

Port number ...........................................................................................................

SM-I 4 - 8 (04.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 4
Installation instructions

Query (attributes)
(The query attributes below will be used to search the worklist server for entries scheduled for the BV-Family
system.)
• Modality Enable/Disable
if Yes +OT / XA / RF
• Scheduled Station AE Title Enable/Disable
• Scheduled Station Name Enable/Disable
• Scheduled Procedure Step Start date: Enable/Disable
if Enable:
Today
Three day range (Yesterday, today and tomorrow)
One week range (1 Week range centered around today)
Two week range (2 Week range centered around today)

MPPS server Information

Manufacturer ........................................................................................................................................

Model ........................................................................................................................................

Version ........................................................................................................................................

Name ........................................................................................................................................

Enable
Yes
No
AE Title ........................................................................................................................................

IP address ........................................................................................................................................

Port number ........................................................................................................................................

3.3.3.4 Target information

Print targets Information

Printer 1

Manufacturer ................................................................................................................................

Model ................................................................................................................................ :

Version ................................................................................................................................ :

Target name in
BV Family user interface ................................................................................................................................

AE Title ................................................................................................................................ :

IP address ................................................................................................................................

Port number ................................................................................................................................

Printer type (to be filled in by Philips) ......................................................................................................................

BV Family R1.2 / Volume 1 (04.0) SM-I 4 - 9


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Section 4 Service Manual BV Family R1.2
Installation instructions

Printer 2

Manufacturer ................................................................................................................................

Model ................................................................................................................................ :

Version ................................................................................................................................ :

Target name in
BV Family user interface ................................................................................................................................

AE Title ................................................................................................................................ :

IP address ................................................................................................................................

Port number ................................................................................................................................

Printer type (to be filled in by Philips) ......................................................................................................................

3.3.3.5 Store targets Information

Store targets can be used either with or without storage commitment. In case of storage commitment
additional the storage commitment AE title, IP address and the Port number have to be entered.

Storage target 1

Manufacturer ........................................................................................

Model ........................................................................................ :

Version ........................................................................................ :

Name (Name which will appear in the BV Family user interface)


........................................................................................

AE Title ........................................................................................ :

IP address ........................................................................................

Portnumber ........................................................................................

Storage Commit (to be used for this target): Enabled / Disabled

In case of a storage commitment application:

• Storage commitment AE Title ........................................................................................

• Storage commitment IP address ........................................................................................

• Storage commitment Port number ........................................................................................

SM-I 4 - 10 (04.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 4
Installation instructions

Storage target 2

Manufacturer ........................................................................................ :

Model ........................................................................................ :

Version ........................................................................................ :

Name (Name which will appear in the BV Family user interface)


........................................................................................

AE Title ........................................................................................ :

IP address ........................................................................................ :

Portnumber ........................................................................................ :

Storage Commit (to be used for this target): Enabled / Disabled

Storage Commit (to be used for this target): Enabled / Disabled

In case of a storage commitment application:

• Storage commitment AE Title ........................................................................................

• Storage commitment IP address ........................................................................................

• Storage commitment Port number ........................................................................................

3.3.3.6 Signature

a. Please sign this questionnaire:

Date ........................................................................................................................................

Name ........................................................................................................................................

Signature ........................................................................................................................................

b. Please fax this questionnaire to (to be filled in by Philips):

Name ........................................................................................................................................

Address ........................................................................................................................................

Fax ........................................................................................................................................

BV Family R1.2 / Volume 1 (04.0) SM-I 4 - 11


Copyright © 2004 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 4 Service Manual BV Family R1.2
Installation instructions

4 ON-SITE INSTALLATION

4.1 CHECK ON POWER SUPPLY REQUIREMENTS

4.1.1 Site mains voltage & frequency check

As the systems are mobile X-ray systems, all the rooms where the systems are going to be used have to be
checked for mains conditions.

− The mains resistance should be checked. The results must be in accordance with the data of the
System Survey Report.
− The mains voltage should be checked. The results must be in accordance with the data of the
System Survey Report.
− The mains frequency should be checked. The results must be in accordance with the data of the
System Survey Report.

SM-I 4 - 12 (04.0) BV Family R1.2 / Volume 1


Copyright © 2004 Koninklijke Philips Electronics N.V.
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Service Manual BV Family R1.2 Section 4
Installation instructions

4.1.2 Mains voltage adaptation

The system uses an internal voltage of 230 V AC.

The system voltage is adjusted to either 120 or 230 V, according tot the wall outlet.
To adapt the system to the different hospital voltages perform the procedure mentioned below:
• For 230 V, cross 120 V out on mains rating label at the rear of the mobile viewing station.
• For 120 V, cross 230 V out on mains rating label at the rear of the mobile viewing station monitor.
• For other voltages, add the new label delivered with the system indicating the programmed voltage.

NOTE

Strike out the unused current value indication on the fuse holder.
________________

4.1.3 Mains voltage programming

To adapt the system to the mains voltage proceed as follows:


1. Remove the rear and front panel of the MVS.
2. Connect the mains input voltage connector according the table below.
3. Program the transformer input voltages at the terminal block by connecting the (5) programming wires
according to the table below.
4. Insert the proper fuses for F1 and F2.
5. In the BV Libra and BV Endura, check or program jumper SEA2:W3 of the Fet power control in the 50 or
60 Hz position, for a drawing refer to SM-CM section 7.
6. In the BV Pulsera, check or position the jumper on the SEA2 board to K1 for 50 or 60 Hz, (the jumper in
the highest position is 50 Hz, in the lowest position is 60 Hz).
7. Re-install the rear and front panel of the MVS.

CAUTION

Check WA1:X5 / X3 connector according the table below. Improper connection could cause damage.
________________

Mains Main input Fuses Transformer lead connected to:


[voltage] to WA1 [F1, F2]
1 2 3 4 5
100 V X5 15 A* 105 101 104 106 109
110 V X5 15 A* 102 101 104 105 109
120 V X5 15 A* 106 101 104 105 109
130 V X5 15 A* 107 101 104 105 109
200 V X3 15 A 105 102 103 107 108
210 V X3 15 A 105 102 103 106 108
220 V X3 15 A 104 102 103 105 108
230 V X3 15 A 106 102 103 105 108
240 V X3 15 A 107 102 103 105 108

* The fuses F1 and F2 should be 30 A for the BV Libra and BV Endura when the Radiography mode is
enabled. If the fuse rating is changed: cross out the incorrect fuse rating on the lable next to the fuses using a
black permanent marker.

BV Family R1.2 / Volume 1 (04.0) SM-I 4 - 13


Copyright © 2004 Koninklijke Philips Electronics N.V.
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Section 4 Service Manual BV Family R1.2
Installation instructions

Check on hardware programming BV Pulsera generator

Set up the stator supply board (SEA 2) as follows:

Mains frequency Jumper position SEA2


K1 K2
50 Hz IN OUT
60 Hz OUT IN

4.1.4 Check on hardware programming of MCU

Based on a proper filled in site survey report the MCU hardware programming has been done in the factory. A
check on this programming is sufficient to control the essential jumper settings.

CAUTION

Incorrect connections can cause malfunctioning of the unit and may cause a Safety Hazard.
________________

System type Position cable Jumper Jumper Jumper Connection


WA – X5 into position position Position between WA – T1:
position WA1 – W1 WA1 – W2 WA1 – W3 115 116
BV Libra WA – X2 1-2 Always open 1–2 Closed
BV Endura WA – X2 1-2 Always open 1–2 Closed
BV Pulsera WA – X3 1-2 Always open 1–3 Open

4.2 INSTALLATION OF RELEVANT OPTIONS

Depending on the ordered options, these options have to be installed and connected as well.
For further information, refer to the Section “Options”. Pre-installation usually has been done during factory
testing.

4.3 CONNECTION OF CABLING & EARTHING

4.3.1 Cabling instructions

No cables need to be attached to walls, floor or ceiling.

CAUTION

Check adaptation of the system to the mains voltage before connecting to the mains.
________________

CAUTION

Never extend or replace the special type hospital mains supply cable of the BV Family System.
Length, earth wire, diameter of cable are subject to legal requirement.
________________

SM-I 4 - 14 (04.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 4
Installation instructions

CAUTION

Hospital mains must be “Hospital Grade” in the USA and Canada. In other countries, the plug must comply
with local safety regulations. For further information, refer to the Section “Technical Data”.
The mains plug can be changed but for max Ri of mains wall outlet, refer to the Section “Technical Data”.
________________

4.3.2 Cabling diagram

Connect all the cables and earthing wires according to this cabling diagram.

4.4 CHECK ON HARDWARE PROGRAMMING SUB-SYSTEMS

4.4.1 Check on hardware programming BV Libra / BV Endura generator


unit

Set the jumper X3 on the FET power control board (SEA 2) to the 50 Hz or 60 Hz position depending on your
mains frequency.

4.4.2 Switching ON

When the system is switching on it performs a system initialization and self-test.

The system is ready to be used when the MVS shows the “Patient administration” on the left (live) monitor and
the CAS display shows the status and settings without error messages.

BV Family R1.2 / Volume 1 (04.0) SM-I 4 - 15


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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

Section 5 SETTING TO WORK PROCEDURE

Contents

1 INTRODUCTION .....................................................................................................................................2

2 SETTING TO WORK PROCEDURES ....................................................................................................3


2.1 Switching the system ON.........................................................................................................................3
2.2 Setting to work the VCR, VCDR & Paper printer [optional, if present] ....................................................3
2.3 Setting to work the DICOM Workflow [optional, if present]......................................................................3
2.4 Customizing the system...........................................................................................................................3

3 SOFTWARE PROGRAMMING ...............................................................................................................4


3.1 Check on the software license authority..................................................................................................4
3.2 Check on software programming of BV Family R1.2 System .................................................................4
3.2.1 Checking the configuration of the BV Family R1.2 System .................................................................4
3.2.2 Checking the System Settings .............................................................................................................5
3.2.3 Checking the Examinations names......................................................................................................9
3.3 Setting to work of DICOM workflow interface ........................................................................................10

4 FUNCTIONAL CHECKS .......................................................................................................................11


4.1 X-ray control function check ..................................................................................................................11
4.2 Iris check................................................................................................................................................11
4.3 II-LAT check...........................................................................................................................................11
4.4 Tank LAT check .....................................................................................................................................11
4.5 Lamp test CAS.......................................................................................................................................11
4.6 Lamp test MVS ......................................................................................................................................11
4.7 Check of [level 1] image quality .............................................................................................................11

5 X-RAY TUBE CONDITIONING .............................................................................................................12


5.1 General ..................................................................................................................................................12
5.2 Conditioning of BV Libra and BV Endura ..............................................................................................12
5.3 Conditioning of BV Pulsera....................................................................................................................13
5.4 Completion of the Setting to Work .........................................................................................................13

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 1


Copyright © 2004 Koninklijke Philips Electronics N.V.
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Section 5 Service Manual BV Family R1.2
Setting to Work procedure

1 INTRODUCTION

After having completed the procedure for unpacking and re-installation of the system, with reference to the
various Sections, the system is ready to be connected to the hospital mains power supply. The BV Family
R1.2 Systems are also pre-adjusted, so no actual new on-site adjustments have to be carried out.
If the previous re-installation measures did not take place, refer to the Section “Installation instructions”.

This Section deals with the setting to work procedure(s) as part of the commissioning: a general check on the
functionality of the system.

In case that software adjustments should be performed, refer to the Section “Adjustment & Verification”.

In general, the delivered equipment could have been stored in warehouses before the setting to work. For this
reason an X-ray tube conditioning program is developed and should be considered.
If the X-ray tube has been out of order for more than 3 months, the conditioning program has to be performed.
A separate procedure is developed for the BV Libra \ BV Endura and the BV Pulsera.

Part of the whole procedure is also a check on the options for the license key. The (32) character string should
allow for the relevant and ordered configuration.

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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

2 SETTING TO WORK PROCEDURES

2.1 SWITCHING THE SYSTEM ON

NOTE

The BV Family R1.2 Systems are earthed through the mains supply cable.
________________

CAUTION

Always allow 10 seconds between switching off and on the power to prevent possible damage to power
supply components in the BV Family R1.2 Systems.
________________

1. Connect the cable between the MVS and the CAS.


2. Plug in the hospital mains cable of the MVS to the mains supply – grounded - wall socket.
3. Switch ON the system by pressing the “Power-on” button on the MVS console or CAS console.
4. Enable the key switch.

2.2 SETTING TO WORK THE VCR, VCDR & PAPER PRINTER [OPTIONAL, IF PRESENT]

Press the I/O button on the VCR/VCDR and the I/O button on the paper/transparency printer for setting to
work of the devices. After the setting to work, the devices are not switched off, due to central on & off
switching (red button) of both the MVS and/or CAS.

2.3 SETTING TO WORK THE DICOM WORKFLOW [OPTIONAL, IF PRESENT]

DICOM functions are integrated in the software. Configuration is required. For more information, refer to SM-
SW section 1, 2 and 3.

2.4 CUSTOMIZING THE SYSTEM

For customizing the BV Family R1.2 Systems, refer to the Section “Customizing the BV Family R1.2 System”.

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 3


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Section 5 Service Manual BV Family R1.2
Setting to Work procedure

3 SOFTWARE PROGRAMMING

3.1 CHECK ON THE SOFTWARE LICENSE AUTHORITY

NOTE

When the system is delivered initially, the user’s software license number has already been entered into in the
factory. The form showing the license number is shipped together with the system. This form should be filed
as a contract document very carefully.
________________

3.2 CHECK ON SOFTWARE PROGRAMMING OF BV FAMILY R1.2 SYSTEM

NOTE

Downloading the application software has to be repeated in case of malfunctioning.


________________

For the complete installation procedure of the BV Family R1.2 System application software, refer to the
Section “Software installation”.

In the factory the settings of the system has been configured based on default values. This check is a check
on programming these default values only.
Perform the Program manual procedures for [configuration and examination of] default programming. A
requirement is the Service PC has been configures according to SM-SW section 3.

3.2.1 Checking the configuration of the BV Family R1.2 System

1. On the MVS, select Enable service


2. Open BV-Scope.
3. Select: Install > Program Manual > System Configuration. The window below appears.

4. Click the Info button. A window appears that gives a survey of installed and not installed options.

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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

3.2.2 Checking the System Settings

Select: Install > Program Manual > System Settings


Perform BV-Scope window instructions System settings to change the APF settings of the BV Family
R1.2 systems.
Scroll setting window for more system settings.

Example for BV Libra and BV Endura:

WARNING

Compliance with IEC 60601-2-43 Interventional Procedures.


For compliance with IEC 60601-2-43, the system must not be customized with ‘Pulsed LDF’ mode as the
switch on default mode ( i.e. Default technique = Exposure and Default X-mode = Pulsed). This mode has a
dose output above the IEC Normal dose level (see table in the technical data section).
As the default Examination can be selected by the User on the MVS interface,
this applies to all examination types.
________________

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 5


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Section 5 Service Manual BV Family R1.2
Setting to Work procedure

Example for BV Pulsera:

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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

Parameter Value range

Common
kV/mA curve Normal, High Contrast, Isowatt
Focus Small, Large
XTV Measure Field Size 0 = auto, 1 ... 7
Left button
Image processing:
Enable subtraction yes, no
Trace black/white black, white
Landmarking level 0 ... 3
Image storage:
Storage Rate [fr/s] 0, 1, 2, 3, 5, 8, 12, 25
Store Last Image Hold yes, no
VCR Control on, off
Video processing
Integration factor 0 ... 60
FM Noise Reduction Level 1, 3/4, 1/2, 1/4, 1/8, 1/16
FM Movement Detection on, off
FM Movement Sensitivity off, low, medium, high
FM Contrast -49 ... +49
FM Brightness -49 ... +49
FM Edge Enhancement off, low, medium, high
FM Video Invert on, off
SM Noise Reduction Level 1, 3/4, 1/2, 1/4, 1/8, 1/16
SM Movement Detection on, off
SM Movement Sensitivity off, low, medium, high
SM Contrast -49 ... +49
SM Brightness -49 ... +49
SM Edge Enhancement off, low, medium, high
SM Video Invert on, off

Table: system settings (APF) parameters for left button

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 7


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Section 5 Service Manual BV Family R1.2
Setting to Work procedure

Parameter Value range

Right button
X-ray generator:
Pulse width short, medium, long
Initial pulse rate (pulsed) 3, 5, 8, 12, 25
Image processing:
Enable subtraction yes, no
Trace black/white black, white
Landmarking level 0 ... 3
Image storage:
Storage Rate [fr/s] 0, 1, 2, 3, 5, 8, 12 25
Store Last Image Hold yes, no
VCR Control on, off
Video processing
Integration factor 0 ... 60
FM Noise Reduction Level 1, 3/4, 1/2, 1/4, 1/8, 1/16
FM Movement Detection on, off
FM Movement Sensitivity off, low, medium, high
FM Contrast -49 ... +49
FM Brightness -49 ... +49
FM Edge Enhancement off, low, medium, high
FM Video Invert on, off
SM Noise Reduction Level 1, 3/4, 1/2, 1/4, 1/8, 1/16
SM Movement Detection on, off
SM Movement Sensitivity off, low, medium, high
SM Contrast -49 ... +49
SM Brightness -49 ... +49
SM Edge Enhancement off, low, medium, high
SM Video Invert on, off

Table: system settings (APF) parameters for right button

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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

3.2.3 Checking the Examinations names

Select Install > Program Manual > Examination names


Perform BV-Scope window instructions Examination names.

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 9


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Section 5 Service Manual BV Family R1.2
Setting to Work procedure

3.3 SETTING TO WORK OF DICOM WORKFLOW INTERFACE

The application software has already been installed in the factory.

For (re)configuration of the software, refer to SM-SW section 1 and 3.

NOTE

To allow for re-configuring the DICOM workflow interface, refer to the site survey data obtained from the user
via the DICOM workflow interface Questionnaire (refer to SMI section 4).
________________

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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

4 FUNCTIONAL CHECKS

Check if the system starts-up without error codes on the display of the MVS or CAS, if not note the error code
and check and perform the service instructions before continuing the functional checks.

4.1 X-RAY CONTROL FUNCTION CHECK

Check the X-ray control functions of the system as described in the “Instructions for Use”.

4.2 IRIS CHECK

Check the iris functions of the system as described in the “Instructions for Use”.

4.3 II-LAT CHECK

Check the II LAT functions of the system as described in the “Instructions for Use”.

4.4 TANK LAT CHECK

Check the tank LAT functions of the system as described in the “Instructions for Use”.

4.5 LAMP TEST CAS

Check the lamps of the CAS as described in the “Instructions for Use”.

4.6 LAMP TEST MVS

Check the lamps of the MVS as described in the “Instructions for Use”.

4.7 CHECK OF [LEVEL 1] IMAGE QUALITY

Check the level 1 image quality performance of the BV Family R1.2 member.

Refer to the System Manual Corrective Maintenance, Section “Image Performance Checks”.

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 11


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Section 5 Service Manual BV Family R1.2
Setting to Work procedure

5 X-RAY TUBE CONDITIONING

5.1 GENERAL

NOTE

Only carry out the X-ray tube conditioning procedure if the X-ray Tank has been out of use for a longer period
of time (+/- 3 months), has been replaced or arcs too much (> 3 times / day).
________________

Perform BV-Scope window instructions as per the relevant BV Family R1.2 System.

5.2 CONDITIONING OF BV LIBRA AND BV ENDURA

The duty cycles for the BV Libra and BV Endura are incorporated in the BV-Scope windows.

[Select BV-Scope path]: Install > Adjustment > X-ray tube > Conditioning
Perform BV-Scope window instructions Conditioning.

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Service Manual BV Family R1.2 Section 5
Setting to Work procedure

5.3 CONDITIONING OF BV PULSERA

The particular values for the BV Pulsera are incorporated in the BV-Scope windows

[Select BV-Scope path]: Install > Adjustment > X-ray tube > Conditioning.
Perform BV-Scope window instructions Conditioning.

5.4 COMPLETION OF THE SETTING TO WORK

This will complete the setting to work procedure. To continue, refer to the Section “Performance check
program”.

BV Family R1.2 / Volume 1 (04.0) SM-I 5 - 13


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Service Manual BV Family R1.2 Section 6
Performance check program

Section 6 PERFORMANCE CHECK PROGRAM

Contents

1 INTRODUCTION .....................................................................................................................................2
1.1 The scope of the checks..........................................................................................................................2
1.2 Required tools & test equipment..............................................................................................................2
1.3 Requirements of status report values ......................................................................................................2

2 PERFORMANCE CHECKS ....................................................................................................................3


2.1 Mechanical checks ..................................................................................................................................3
2.2 Functional test..........................................................................................................................................4
2.2.1 X-ray control function check.................................................................................................................4
2.2.2 Iris check ..............................................................................................................................................5
2.2.3 Laser aiming device check...................................................................................................................5
2.2.4 Laser alignment tool check ..................................................................................................................5
2.2.5 Beep and lamp test C-arm stand .........................................................................................................5
2.2.6 Beep and lamp test mobile viewing station..........................................................................................5
2.3 Image quality check [level 1]....................................................................................................................6

3 CHECK LOCALLY REQUIRED COMPLIANCE(S)................................................................................7

4 COMPLETION OF THE PERFORMANCE CHECK PROGRAM ...........................................................7

BV Family R1.2 / Volume 1 (04.0) SM-I 6 - 1


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Section 6 Service Manual BV Family R1.2
Performance check program

1 INTRODUCTION

After the system is commissioned on site, a number of performance checks have to be carried out to ensure
that the BV Family R1.2 System(s) are functioning properly and within specification(s).

1.1 THE SCOPE OF THE CHECKS

NOTE

The function of all operator controls and indicators are described in the Instructions for Use as per the relevant
BV Family R1.2 Systems: BV Libra, BV Endura or BV Pulsera.
________________

The performance check program will be as follows:


1. [Mechanical] movement checks
2. Functional checks
3. IQ [level 1] checks

On-site testing is restricted, because X-ray performance testing can only be carried out with certain
constraints to the required facilities. However, the whole performance testing has been done in the factory, for
which a full status report will be supplied together with each individual system delivered. Reference will be
made to the relevant measured data as stored under the Section “Record of Measured Data”.

In this Section, the mechanical movement and functional checks are described. For the image performance,
refer to the System Manual Corrective Maintenance, Section “Image performance checks”.

1.2 REQUIRED TOOLS & TEST EQUIPMENT

The standard recommended service kit will be sufficient to do the on-site [IQ] performance checks. Refer to
the Section “General Introduction”.

For [level 1] image quality measurements, a set of special IQ phantoms is required. The content list is part of
the Section “Image performance checks”.

1.3 REQUIREMENTS OF STATUS REPORT VALUES

The minimum and maximum IQ system values are given in the status report.

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Service Manual BV Family R1.2 Section 6
Performance check program

2 PERFORMANCE CHECKS

2.1 MECHANICAL CHECKS

CAUTION

Prior to rotate the C-arm, measures must be taken to avoid the 12” II/TV camera to touch anything.
An uncontrolled touch down will damage the camera.
________________

The mechanical movements as described in the Technical Data of the Instructions for Use have to be
checked. The movements can be split up in the following categories:

Check Description
Angulation Check the functioning: +90˚ / -25˚ (+90˚ / -45˚ for extended rotation)
Rotation Check the functioning: beyond +/- 180˚, safety stop at 155˚
Panning movement Check the functioning: +/- 10˚
Longitudinal travel Check the functioning: 20 cm
Motorized height movement Check the functioning: +43 cm / -6 cm
(+41 cm / -8 cm for BV Libra and Extended Rotation)
Horizontal movement Check the functioning of the transportation brakes. For drawings, refer
to SM-I section 1
Cable deflectors Check for presence and damage
Brakes and locks Check the functioning
All mechanical stops Check the functioning
Fasteners and cables Check for damage
Wheels, wheel alignment and cable Check the functioning
deflectors
LCD arm (optional) Check the functioning

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Section 6 Service Manual BV Family R1.2
Performance check program

2.2 FUNCTIONAL TEST

User routine checks program

The user of a BV-Family system must institute a User Routine Checks Program as detailed in the table below.
Normally, the user will instruct operators to perform these checks and any corresponding actions. In any case,
it is for the operator of the system to make sure that all checks and actions have been satisfactorily completed
before using the system for its intended purpose.

Check Description Frequency

Accessories Availability and integrity Daily 1


Cable deflectors Check for presence and damage Daily 1
Brakes, wheels, steering Ensure correct function Daily 1
Cabling Inspect all cables for kinks and/or cracks Daily 1
Beep and lamp test Check for correct function 3 After start-up 1
Connectors Check correct connection and damage Daily 1
Power-on Check display and monitor for error messages Before use 1
X-ray Ensure correct function 3 Daily 1
Check beep and lamp 3 Daily 1
Check iris settings and verify their position 3 Daily 1

Check the correct function of the system lock Daily 1

Ensure correct function of the keys Daily 1


C-arm stand Check for battery charge warning message After start-up

Energy storage unit Check for damage and correct function Daily 1
(Pulsera only)
Hand switch Check for damage and correct function Daily 1
Foot switch Check for correct function Daily 1
Height movement Ensure correct function of the monitors Daily 1
Mobile viewing station Ensure correct function of the keys Daily 1
Check for damage and correct function Daily 1
Remote control Check for correct alignment 3 Daily 1
Laser alignment tool Check for correct function and paper/ transparency presence Daily 1
Printer Check for correct function/tape presence Daily 1
VCR Check for correct function/cd-r(w) presence Daily 1
VCDR

¹ Visual and/or audible checks.


² Contact Service for advice on error messages which appear after start-up.
³ For detailed instructions see below.

2.2.1 X-ray control function check


The X-ray control function check should be performed daily without any objects in the X-ray beam.
1. Press the ‘kV’ soft key to select manual kV.
2. Enter 70 kV.
3. Press the ‘kV’ soft key to select automatic kV and perform fluoro.
4. If the kV value drops to 42 - 47 kV, the X-ray control function is working properly.

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Service Manual BV Family R1.2 Section 6
Performance check program

2.2.2 Iris check


The iris should be checked daily.
1. Perform fluoroscopy without any objects in the X-ray beam and close the iris to about half the size.
2. Press the |Select iris| key. The iris circle is displayed.
3. When the circle covers the edge of the image the iris setting is correct.
4. Perform the steps for the other II sizes.

2.2.3 Laser aiming device check


The laser aiming device check should be checked daily or directly after installation of the device.
1. Aim the laser. (Refer to SM-CM 5, chapter ‘Laser alignment tool’ and to the Instructions for use, chapter
‘Laser positioning tools’).
2. Place a pair of scissors, with its scissor point in the laser beam at 30 cm of the II.

Figure: Laser aiming device check with scissor point

3. Perform fluoro.
4. Check if the scissor point coincides with the marking on the image.

2.2.4 Laser alignment tool check


The laser alignment tool (LAT) alignment check should be checked daily.
1. Install the target plate on the II (Refer to the Instructions for use, chapter ‘Laser positioning tools’).
2. Turn the laser on by pressing the |LAT on/off| key.
3. Check if the laser cross coincides with the centre of the lead target plate cross.

2.2.5 Beep and lamp test C-arm stand


The beep and lamp test should be performed after start-up.
1. Press the |Information| and the |Reset shutter(s)/iris| keys simultaneously to activate the beep and lamp
test.
All LEDs are illuminated, a blank (i.e. white/amber) screen will be displayed and all buzzers will sound.
2. Release the keys, or one of the keys, to stop the beep and lamp test.

2.2.6 Beep and lamp test mobile viewing station


The beep and lamp test should be performed after start-up.
1. Press the |Ctrl| and |Shift| keys simultaneously to activate the beep and lamp test.
A short beep sounds and all LEDs and the X-ray on indicator lamp will be turned on.
2. Release the keys, or one of the keys, to stop the beep and lamp test.

BV Family R1.2 / Volume 1 (04.0) SM-I 6 - 5


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Section 6 Service Manual BV Family R1.2
Performance check program

A BV Family R1.2 System will start up in the fluoro mode, it should then be checked on its functionality.

Check Description
Accessories Availability and integrity
Cabling Inspect all cables for kinks and/or cracks
Beep and lamp test Check for correct function after start-up
Connectors Check for correct connection and damages
Power-on Check display and monitor for error messages
X-Ray Ensure correct function
Check X-ray indications and beep (with High Dose Fluoroscopy
and after making an Exposure)
Check Collimator settings and verify position
Check correct function of the (optional) system lock
C-arm stand Ensure correct function of the keys
Hand-switch Check for damage and correct function
Foot-switch Check for damage and correct function
Energy Storage Unit (BV Pulsera only) Check for battery charge warning message after start-up
Mobile Viewing Station Ensure correct functioning of the monitors
Mobile Viewing Station Ensure correct functioning of the keys

X-Ray control function check


The X-ray control function check should be performed without any objects in the X-ray beam.
1. Press the ‘kV’ soft key to select manual kV.
2. Set kV value to 70 kV.
3. Press the ‘kV’ soft key to select automatic kV and perform fluoro.
4. If the kV value drops to 42 - 47 kV, the X-ray control function is working properly.

Collimator check
1. Perform fluoroscopy without any objects in the X-ray beam and close the iris to about half the size.
2. Stop Low Dose Fluoroscopy.
3. Press the |Select iris| key for a moment (the collimator iris circle is displayed).
4. When the circle covers the edge of the image the iris setting is correct.
5. Perform the steps for the other II sizes.
6. Perform the steps 1 to 5 for shutters instead of the iris.

Radiography check
1. Make the iris as small as possible and check the visual position of the iris.
2. Check if during a switch to radiography the iris does not move.
3. Check if during a switch to film the iris opens.
4. Make an exposure with 40 kV and the lowest possible mAs and check for beeps after exposure.

2.3 IMAGE QUALITY CHECK [LEVEL 1]

For the [level 1] image quality performance checks, refer to the System Manual Corrective Maintenance,
Section “Image Performance Checks”.
The Image performance checks are part of this Performance check program and shall be carried out
immediately after finalizing the functional checks.

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Service Manual BV Family R1.2 Section 6
Performance check program

3 CHECK LOCALLY REQUIRED COMPLIANCE(S)

These checks have to be investigated by the local PMS SSR/SSD organization and attached to this Section of
the Service Manual.

4 COMPLETION OF THE PERFORMANCE CHECK PROGRAM

This will complete the Performance check program. To continue, refer to the Section “Hand over procedure”.

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Service Manual BV Family R1.2 Section 7
Hand-over procedure

Section 7 HAND-OVER PROCEDURE

Contents

1. INTRODUCTION .....................................................................................................................................2

2. PERFORM QUICK CHECKS FOR USER ACCEPTANCE ....................................................................3


2.1. Required documentation..........................................................................................................................3
2.2. Required tools & test equipment..............................................................................................................3
2.3. The test programme ................................................................................................................................4
2.3.1. The setting to work results ...................................................................................................................4
2.3.2. Optimization of the printer [optional, if present] ...................................................................................4
2.4. Evaluation of the test results....................................................................................................................4
2.5. System status report [SSR] .....................................................................................................................4

3. HAND OVER CERTIFICATE ..................................................................................................................4

4. COMPLETION OF THE COMMISSIONING OF THE SYSTEM .............................................................4

BV Family R1.2 / Volume 1 (03.1) SM-I 7 - 1


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Section 7 Service Manual BV Family R1.2
Hand-over procedure

1. INTRODUCTION

After the BV Family R1.2 System has been unpacked, installed, set to work and the performances checked,
the owner and the FSE have made sure that the system is operating in accordance with the specifications.
This Section describes the evaluation of the results of the witnessed performance checks and enables the
owner and/or user to accept the system accordingly.

IEC requires to check the performances at a regular basis. It should be advised, due to the specialistic know-
how, the special environment necessary (to be able to do the performance checks) and the special tools &
test equipment required, to have these services rendered by the supplier of the system. For this reason PMS
has developed a general Planned Maintenance service contract including a regular [image] performance
check programme.

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Service Manual BV Family R1.2 Section 7
Hand-over procedure

2. PERFORM QUICK CHECKS FOR USER ACCEPTANCE

2.1. REQUIRED DOCUMENTATION

To be able to carry out a selection of performance checks, the performance quick checks, the following
documentation is required:
− Shipping documents;
− Service Manual;
− Factory released measured data;
− IQ Performance Manual;
− A dedicated test programme;
− An advice to the owner to witness certain tests;

2.2. REQUIRED TOOLS & TEST EQUIPMENT

To carry out the performance checks the standard service kit is required. Refer to the Section “General
Introduction”.

BV Family R1.2 / Volume 1 (03.1) SM-I 7 - 3


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Section 7 Service Manual BV Family R1.2
Hand-over procedure

2.3. THE TEST PROGRAMME

2.3.1. THE SETTING TO WORK RESULTS

The test results are available, refer to the previous setting to work procedures.

2.3.2. OPTIMIZATION OF THE PRINTER [OPTIONAL, IF PRESENT]

Refer to the PEI manaul “VCR / paper printer”.

2.4. EVALUATION OF THE TEST RESULTS

In the Technical Data the evaluation criteria has been tabled. As long as the results are within the prescribed
tolerances, the system is working within specification. The system could be handed over end used by
specified and qualified personnel.

2.5. SYSTEM STATUS REPORT [SSR]

After having completed the programme successfully, a SSR will be composed to inform the owner and the
PMS X-ray HelpDesk. This initial field SSR will form the basis for future periodical control on performances
and has to be stored and archived carefully.

3. HAND OVER CERTIFICATE

To hand over the system to the owner a hand-over certificate has to be signed by PMS and the owner. The
date of signing this certificate is also the date, the warranty period will start. The hand over certificate, the
invoice and the service documentation together will form the [contractual] warranty document.

4. COMPLETION OF THE COMMISSIONING OF THE SYSTEM

This will complete the commissioning procedure. To continue, refer to the Section “Customizing the BV
Family R1.2 System”.

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Service Manual BV Family R1.2 Section 8
Customizing the BV Family System

Section 8 CUSTOMIZING THE BV FAMILY SYSTEM

Contents

1 INTRODUCTION .....................................................................................................................................2

2 CUSTOMIZING THE SYSTEM................................................................................................................3


2.1 Default settings ........................................................................................................................................3
2.1.1 Customizing the BV Family R1.2 system.............................................................................................4
2.1.2 Example programming System setting ................................................................................................5
2.1.3 Dose limitations ....................................................................................................................................6
2.1.4 DICOM configuration............................................................................................................................6
2.2 Customizing the user printer....................................................................................................................7

BV Family R1.2 / Volume 1 (04.0) SM-I 8 - 1


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Section 8 Service manual BV Family R1.2
Customizing the BV Family System

1 INTRODUCTION

The BV Family R1.2 Systems can be customized upon request of the user. This customization program will be
carried out after the hand over of the system has taken place to avoid differences in test results between
factory and on site tests.

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Service Manual BV Family R1.2 Section 8
Customizing the BV Family System

2 CUSTOMIZING THE SYSTEM

2.1 DEFAULT SETTINGS

Customization takes place through the BV-Scope windows with the BV Family R1.2 System
The default values are:

System configuration, settings panel:

Parameter Default
System Serial number 830
Shutter L + R Coupled No
Camera angle [deg] 0
Radiography possible Yes
No. of examinations types 5
Max kV [kV] 110
French Homologation No
Gamma Correction 1
Initialize Image Disk NO
SW License Key ‘clear’

User configuration, settings panel:

Parameter Default
Hospital name ‘clear’
Language English
Birth date field as Birth date
Data Format dd-mm-yyyy
Live additional text OFF
Display Exam type Yes
Units of measure 0.1 mm

For dose limitations, refer to SM-CM section Adjustment & Verification.

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Section 8 Service manual BV Family R1.2
Customizing the BV Family System

2.1.1 Customizing the BV Family R1.2 system

The BV Family R1.2 system is delivered whereas the site-specific information still has to be configured.

Procedure:

[Select BV-Scope path]: Install > Program Manual > Site Specific
Perform BV-Scope window instructions Site Specific Configuration.

2 Setting window

Parameter Value Value default


range steps

Initialize Image Disk NO, YES n.a. NO


(see the Note below the table) (see the Note below the table)
Run Buffer Size* 5 ... 45 1 • with mem ext. 50 set to 10
10 ... 495 1 • with mem ext. 500 set to 100
10 ... 500 1 • with mem ext. 1000 set to 100
10 ... 2500 1 • with mem ext. 5000 set to 1000
10 ... 5000 1 • with mem ext. 10.000 set to 2500
Cocktail: contrast [1] 50 ... 150 1 115 %
Cocktail: contrast [2] 50 ... 150 1 130 %
Cocktail: contrast [3] 50 ... 150 1 150 %
Cocktail: brightness [1] 50 ... 150 1 104 %
Cocktail: brightness [2] 50 ... 150 1 109 %
Cocktail: brightness [3] 50 ... 150 1 113 %
*) Gives the amount of images that is always left free for storing runs.

NOTE

The runs and images are removed if YES is selected. No other data is removed. If the run buffer size is
changed then the service engineer is forced to initialize the image disk.
________________

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Service Manual BV Family R1.2 Section 8
Customizing the BV Family System

2.1.2 Example programming System setting


WARNING

Compliance with IEC 60601-2-43 Interventional Procedures.

For compliance with IEC 60601-2-43, the system must not be customized with ‘Pulsed LDF’ mode as the
switch on default mode ( i.e. Default technique = Exposure and Default X-mode = Pulsed). This mode has a
dose output above the IEC Normal dose level (see table in the technical data section). As the default
Examination can be selected by the User on the MVS interface, this applies to all examination types.
________________

[Select BV-Scope path]: Install > Program Manual > System settings
Perform BV-Scope window instructions System settings;(Scroll the reference/settings if required)

Actual Examination name


Last Exam. Update Date
Common
kV/mA curve Normal
Focus Small
XTV Measure Field Size 0
Left button Right button
X-ray generator:
Pulse width (Pulsera only) short
Initial pulse rate (Pulsera only) 3
Image processing:
Enable subtraction yes Enable subtraction yes
trace black/white black trace black/white black
Landmarking level 0 Landmarking level 0
Image storage:
Storage Rate [fr/s] 0 Storage Rate [fr/s] 0
Store Last Image Hold no Store Last Image Hold no
VCR Control off VCR Control off
Video processing
Integration factor 0 Integration factor 0
FM Noise Reduction Level 1 FM Noise Reduction Level 1
FM Movement Detection off FM Movement Detection off
FM Movement Sensitivity off FM Movement Sensitivity off
FM Contrast 0 FM Contrast 0
FM Brightness 0 FM Brightness 0
FM Edge Enhancement off FM Edge Enhancement off
FM Video Invert off FM Video Invert off
SM Noise Reduction Level 1 SM Noise Reduction Level 1
SM Movement Detection off SM Movement Detection off
SM Movement Sensitivity off SM Movement Sensitivity off
SM Contrast 0 SM Contrast 0
SM Brightness 0 SM Brightness 0
SM Edge Enhancement off SM Edge Enhancement off
SM Video Invert off SM Video Invert off

Table: System Settings window, example for Endura & Pulsera

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Section 8 Service manual BV Family R1.2
Customizing the BV Family System

[Select BV-Scope path]: Install > Program Manual > System Settings; 01: Orthopaedics
Perform BV-Scope window instructions System settings
(Scroll setting window for more system settings.)

System Settings window, example

2.1.3 Dose limitations

For dose limitations, refer to SM-CM section Adjustment & Verification.

2.1.4 DICOM configuration

For DICOM configuration, refer to SM-SW section 3.

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Service Manual BV Family R1.2 Section 8
Customizing the BV Family System

2.2 CUSTOMIZING THE USER PRINTER

To optimize the user printer upon user’s requirements the FSE will adjust this accordingly. For details about
how to customize the User’s printer, refer to the PEI manual “VCR / Paper printer”.

After having customized the system, the BV Family System is completely re-installed and is ready for actual
operation to be performed by the user.

NOTE

Write down changed values in the ‘User changed APF settings’ in the Instructions for Use.
Make a copy of the new values on disk.
________________

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Service Manual BV Family R1.2 Section 9
Record of measured data

Section 9 RECORD OF MEASURED DATA

Contents

1. INTRODUCTION .....................................................................................................................................2

2. MEASURED DATA .................................................................................................................................2

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Section 9 Service Manual BV Family R1.2
Record of measured data

1. INTRODUCTION

In this Section the factory measured [performance] data of the system have to be filed. Any change in data
due to (regular) performance measurements should be filed here as well.

2. MEASURED DATA

The measured data

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Service Manual BV Family R1.2 Section 10
Modifications

Section 10 MODIFICATIONS

Contents

1. INTRODUCTION .....................................................................................................................................2

2. MODIFICATIONS ....................................................................................................................................2

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Section 10 Service Manual BV Family R1.2
Modifications

1. INTRODUCTION

In this Section the Field Changes / Field Change Orders have to be filed.

2. MODIFICATIONS

Field Change orders

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