Philips Healthcare

Testing MobileDiagnost wDR

Level 0 Documentation

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Testing MobileDiagnost wDR

Proprietary Notice:

This document and the information contained in it is proprietary and confidential information of Philips Healthcare
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Testing MobileDiagnost wDR

SERVICE MANUAL - Unit

Testing MobileDiagnost wDR

Type No.:

4512 988 05551

released: 07/2011

List of Pages and Drawings

1....25
2Z-10 11.0 A3 MobileDiagnost wDR

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 Testing MobileDiagnost wDR

TESTING MOBILEDIAGNOST WDR

Contents
1 System handover confirmation sheet ...................................................................... 5

2 System - final test ................................................................................................... 6

3 Wireless Portable Detector (WPD) - final test ........................................................ 8

4 Visual inspection ..................................................................................................... 10

4.1 Procedure ............................................................................................................................... 10
4.2 Safety related markings, labels, and labeling ........................................................................ 10
4.3 Checklist visual inspection ..................................................................................................... 11

5 Measurements ......................................................................................................... 13
5.1 Measuring the protective earth conductor resistances .......................................................... 13
5.1.1 Test points MobileDiagnost wDR .......................................................................... 15
5.2 Measuring the earth leakage current ..................................................................................... 17
5.2.1 Procedure ............................................................................................................. 17
5.2.2 Test points MobileDiagnost wDR .......................................................................... 19
5.3 Measuring the dose area product .......................................................................................... 21
5.3.1 Dose area product meter ...................................................................................... 21
5.3.2 Dose area product results MobileDiagnost wDR .................................................. 23

Drawings
Labeling................................................................................................................................................ 2Z-10

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Testing MobileDiagnost wDR

1 System handover confirmation sheet

This sheet must be signed by the responsible FSEs at the end of the installation process and filed in
the SRM.

System ID
Order number
Hospital name
Hospital address
Street
City
Postal code
Country
Start of Installation
End of installation

All tests performed according SMI MobileDiagnost wDR 4512 988 05321 REV____
to SMI
(select SMI and enter revi‐
sion):
FSE 1 Name: Signature:

Date:

FSE 2 Name: Signature:

Date:

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 Testing MobileDiagnost wDR

2 System - final test

Test Required value Measured value Passed Failed
Configuration/Adjustment (SMI MobileDiagnost wDR > Setting-to-work)
Printers calibrated - -

Monitor calibrated (if applicable) - -

Detector calibrated (WPD) - -

Test Required value Measured value Passed Failed

Alignment test (SMI MobileDiagnost wDR > Testing)
Alignment test of the collimator light field ______ mm
with respect to the X-ray field |a1|+ |a2| < 0.02 × S
|b1|+ |b2| < 0.02 × S
Detector tests (SMI MobileDiagnost wDR > Testing)
Detector test (WPD) - -

Universal test object and constancy (SMI MobileDiagnost wDR > Testing)
Universal test object - -

Constancy - -

Electrical tests (SMI MobileDiagnost wDR > Testing)

Measuring the protective earth conduc‐ see chapter Meas‐ record in chapter
tor resistances uring the protective Measuring the pro‐
earth conductor re‐ tective earth con‐
sistances ductor resistances
Measuring the earth leakage current see chapter Meas‐ record in chapter
uring the earth Measuring the
leakage current earth leakage cur‐
rent

Test Required value Measured value Passed Failed

Functional tests (SMI MobileDiagnost wDR > Testing)
Checking the cables - -

Check of movements and brakes - -

Checking the drive function - -

Checking the bumper function - -

Checking the function of the emergency - -

switch
System start-up - -

Indicators - -

Testing the RIS connection - -

Releasing an exposure - -

Sending data to PACS - -

Sending data to printer - -

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Testing MobileDiagnost wDR

Test Required value Measured value Passed Failed

Handover preparation (SMI MobileDiagnost wDR > Handover preparation)
Instructions for Use MobileDiagnost - -
wDR available in local language

FSE Initials:

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 Testing MobileDiagnost wDR

3 Wireless Portable Detector (WPD) - final test

Test Required value Measured value Passed Failed
Setting-to-work (SMI MobileDiagnost wDR > Setting-to-work)
Different WiFi frequencies used for - -
WPDs in neighboring rooms (if applica‐
ble)
All labels are present and contain re‐ - -
quired information
Handover preparation (SMI MobileDiagnost wDR > Handover preparation)
WPD shock sensor not activated - -

FSE Initials:

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Testing MobileDiagnost wDR

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 Testing MobileDiagnost wDR

4 Visual inspection

4.1 Procedure
• Verify that all safety-related markings, labels, and labelings are legible and complete.
• Check the integrity of

– all mechanical parts

– the collision protection
– the corrugated hose.
• Pay special attention to any damage or contamination.
• Verify that the required documentation is present and reflects the current revision of the system/com‐
ponent.
• Fill in the list at the end of this chapter.

4.2 Safety related markings, labels, and labeling

Check whether the labeling complies with the drawing "2Z-10" (MobileDiagnost wDR) at the end of
this section.
Yes No
The labeling at the MobileDiagnost wDR complies with the drawing.

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Testing MobileDiagnost wDR

4.3 Checklist visual inspection

File the checklist in the System Reference Manual, section Record of measured data.

Testing organization: Philips Test before putting into service (ref. value)
Other: Recurrent test
Test after repair
Name of testing person:

Overall assessment:
Yes No n.A.
The safety-related markings, labels and labeling are legible, complete, and according
to the specific labeling overview.(1)
The integrity of all mechanical parts is given.(1)
All corrugated hoses are in good condition.(1)
The collision protection works properly.(1)
The system / component has no "relevant" damages.(1)
The system / component has no "relevant" contaminations.(1)
The required documentation is present.(1)
The present documentation reflects the current revision of the system / component.(1)
(1) In case any of the parameters do not meet the requirements or deviations occur, contact your regional Philips call center to enter a Clarify entry.

Remarks:

Next recurrent test is necessary within the next 24 months!

Name: _____________________________ Date/Signature: _____________________________

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 Testing MobileDiagnost wDR

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Testing MobileDiagnost wDR

5 Measurements

5.1 Measuring the protective earth conductor resistances

• Measure the protective earth conductor resistance between the central earth connector (reference
point) and the test points listed in the tables below.
• Verify that the results are within the specifications.
• Record the measured results in the following tables.

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Testing MobileDiagnost wDR

5.1.1 Test points MobileDiagnost wDR

Testing organization: Philips Test before putting into service (reference
value)
Other: Recurrent test
Test after repair

Name of testing person:

Equipment:
Type of measuring device: Production no. / Serial Nr.:
Date of last calibration:

Measurement of the protective earth conductor resistances between the central earth connector and
the following points.
Test points Component Test point Result (Impe‐ Permissible resistance
dance)
1 Mobile unit Metal cover external mΩ ≤300 mΩ
connector
2 Parking catch Parking catch mΩ ≤300 mΩ
3 Telescope Parking notch mΩ ≤300 mΩ
4 Docking station Connector docking sta‐ mΩ ≤300 mΩ
tion
5 Collimator Rails collimator mΩ ≤300 mΩ
6 Tube Screw tube rotation mΩ ≤300 mΩ
7 Tube High-voltage plug mΩ ≤300 mΩ
8 Control handle Screw at control handle mΩ ≤300 mΩ
9 Column Screw on top of the col‐ mΩ ≤300 mΩ
umn

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 Testing MobileDiagnost wDR

(Fig. 1)

Overall assessment:
No safety or functional deficiencies were detected!
No direct risk, deficiencies detected may be corrected on short term!
Equipment shall be taken out of operation until deficiencies are corrected!
Equipment does not comply - Modification / Exchange of components / Taking out of service is
recommended!

Next recurrent test is necessary within the next 24 months!

Name: _____________________________ Date / Signature: _____________________________

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Testing MobileDiagnost wDR

5.2 Measuring the earth leakage current

5.2.1 Procedure
• Connect the multimeter and the measuring device (MD) between the earth terminal of the wall socket
and the earth terminal of the equipment mains plug (see figure below).

• Measure the earth leakage current under the conditions as mentioned in the table.
• Measure with TC 187 Electrical Safety Analyzer. Connect the System to the Analyzer.

For detailed instruction, refer to the User Manual of Electrical Safety Analyzer.

• Record the values in the table.

• The leakage current for mobile systems does not exceed 500 µA.

Important Switches S1 - S3 are only virtual switches which are not present in the system!
They merely serve the purpose of demonstrating what connection needs to be separated for the indi‐
vidual measurements.

S1 S2 S3 System Value
SF / NC
closed closed closed NC
closed closed open SF
closed open closed SF
open closed closed SF

Figure: schedule for earth leakage current test (schematic diagram)

L S1
Mains N Equipment
S2
PE
S3
R1
R2
C1
IEC MD

DVM

(Fig. 2)

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 Testing MobileDiagnost wDR

Important Instead of an IEC measuring device tool a current clamp can also be used.
The current clamp also measures with frequencies above 1 kHz, which is not according to the IEC
specification!
For this reason, measurements must be done with an IEC measuring device tool if the measured earth
leakage current of the equipment (parts) is out of limit.

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Testing MobileDiagnost wDR

5.2.2 Test points MobileDiagnost wDR

Testing organization: Philips Test before putting into service (reference
value)
Other: Recurrent test
Test after repair

Name of testing person:

Equipment:
Type of measuring device: Production no. / Serial no.:
Date of last calibration:

Measurement of the earth leakage current

Test points Component Test point Result Permissible earth leak‐
age current
1 Measuring point 500 µA

Figure: schedule for earth leakage current test (schematic diagram)

L S1
Mains N Equipment
S2
PE
S3
R1
R2
C1
IEC MD

DVM

(Fig. 3)
Overall assessment:
No safety or functional deficiencies were detected!
No direct risk, deficiencies detected may be corrected on short term!
Equipment shall be taken out of operation until deficiencies are corrected!
Equipment does not comply - Modification / Exchange of components / Taking out of service is
recommended!

Next recurrent test is necessary within the next 24 months!

Name: _____________________________ Date / Signature: _____________________________

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 Testing MobileDiagnost wDR

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Testing MobileDiagnost wDR

5.3 Measuring the dose area product

5.3.1 Dose area product meter

• Set the SID to 100 cm.
• Collimate the X-ray field to 18 × 18 cm (324 cm2).
• Select an examination.
• Set the exposure parameters to 70 kV, 25 mAs, and large focus.
• Release an exposure.
• Read the dose area value on the UI. It must be 32 µGym2 with a tolerance of ± 25 percent (min. 24
µGym2, max. 40 µGym2)
• Note the measuring result in the table of the SRM.

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Testing MobileDiagnost wDR

5.3.2 Dose area product results MobileDiagnost wDR

Testing organization: Philips Test before putting into service (reference
value)
Other: Recurrent test
Test after repair

Name of testing person:

Measurement of the dose area product

Verify by ticking the box.

Permissible dose area product (±25 percent) Result (value) Check

Yes No
32 µGym2 (min. 24 µGym2, max. 40 µGym2)

Overall assessment
Overall assessment:
No safety or functional deficiencies were detected!
No direct risk, deficiencies detected may be corrected on short term!
Equipment must be taken out of operation until deficiencies are corrected!
Equipment does not comply - Modification/Exchange of components/Taking out of
service is recommended!

Next recurrent test is necessary within the next 24 months!

Name: _____________________________ Date / Signature: _____________________________

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 A - Coloum C - X-ray tube assembly
A
Logo Address
not visible / under the cover
Type+S/N DHHS Manufactured Logo / name
Unit model Manufactured
Techn. Data Environment Ser.No. Unit model
Insert model Ser.No.
IEC60601-1 IEC60601-2-32 Ser.No. Insert model
Techn. data Ser.No.
CSA CE Address Techn. data C
DHHS Address F
CE + UL UL
Country of origin Country of origin

Type (Generator) Address E B H

B - Arm (2x)
D - Name-plate
G
Warning
MobileDiagnost wDR D
K

E - Collimator / Laser G - Mains connection K - Docking station

detail c
view of below
1 Laser 2 Lasers

110 Vac or 230 Vac Wireless portable detector

a Labeling for
a Wireless portable detector
see
b 4512 983 15261
b 2Z-10

c
Laser Laser Laser
detail a detail b Warning Warning Appearance Appearance Warning Appearance

Schubert / Koeser
F - Collimator / Ident H - Console / User Interface

Warning label / X-radiation

24.06.2011
rear side USA + Canada only

A3
Labeling
Logo Address

Type+S/N Electr. data DHHS MobileDiagnost wDR

CE / Environment
MOBILE DIAGNOST WDR CSIP Level 0 ( 11.0 ) 2Z-10
C Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED