Philips Healthcare

MobileDiagnost wDR

Level 0 Documentation

IATD

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and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written per‐
mission of the Philips Legal Department. This document or digital media is intended to be (a.) used by customers and is licensed to them as
part of their Philips equipment purchase or (b.) used to meet regulatory commitments as required by the FDA under 21 CFR 1020.30 (and any
amendments to it) and other local regulatory requirements. Use of this document or digital media by unauthorized persons is strictly prohibited.

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 CSIP statement

Proprietary Notice:

This document and the information contained in it is proprietary and confidential information of Philips Healthcare
("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disse-
minated without the prior written permission of the Philips Legal Department. Use of this document and the infor-
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cated at the customer’s designated site. Use of this document by unauthorized persons is strictly prohibited. Re-
port violation of these requirements to the Philips Legal Department. This document must be returned to Philips
when the user is no longer licensed and in any event upon Philips’ first written request.

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Contents

Contents

1 Introduction.................................................................................................................... ...... 5
1.1 Introduction................................................................................................................................... ........ 5

1.2 Regulatory Compliance................................................................................................................. ........ 5

1.3 Manual history............................................................................................................................... ........ 5

2 Workbook...................................................................................................................... ...... 5
2.1 IATD Test Completion Form......................................................................................................... ........ 5

2.2 Labeling......................................................................................................................................... ........ 9

2.3 Documentation.............................................................................................................................. ........ 9

2.4 System/Component Design and Performance.............................................................................. ........ 9

3 Appendix....................................................................................................................... .... 10
3.1 List of Required Tests .................................................................................................................. ...... 10

Glossary........................................................................................................................ .... 13
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MobileDiagnost wDR

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Introduction

1 Introduction

1.1 Introduction
Test results for tests required by regulation 21 CFR Part 1020 must be recorded and kept available
for FDA inspection. This Installation Acceptance Testing Document (IATD) covers the docu-
mentation of all required on site tests.
A list of all requirements and the corresponding 21 CFR Part 1020 sections can be found in the ap-
pendix.

1.2 Regulatory Compliance

Information regarding regulatory compliance of this medical device can be obtained at:
Philips Medical Systems Hamburg
Röntgenstraße 24
22335 Hamburg
Germany

1.3 Manual history

Date 12 NC Reason of changes

August 2011 4512 988 05601 REV AA New IATD for MobileDiagnost wDR
April 2014 4512 988 05602 REV AA New item to check: source-skin distance
May 2014 4512 988 05602 REV AB Title image removed
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2 Workbook
• Perform all tests listed in this workbook.
Test instructions are available in the SMI delivered with the system.
• Record all test results in this workbook.
Tests that are not applicable for the specific on site configuration should be marked as N/A.
• Sign each page of the workbook with initials and date.
• Complete the IATD test completion form at the beginning of the workbook.
• Return a copy of this IATD together with form FDA 2579.

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Manual history Workbook

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Workbook IATD Test Completion Form

2.1 IATD Test Completion Form

This sheet must be signed by the responsible FSEs at the end of the IATD testing.

Factory SO (SAP order

No.)
(refer to the packing list)
Key market PO (purchase
order No.)
(refer to the packing list)
System serial number
(refer to drawing 2Z-10
System Labeling)
System ID
Order number
Hospital name
Hospital address
Street
City
Postal code
Country
Start of Installation
End of installation

All tests performed according to SMI MobileDiagnost _ _ _ _ 4512 988 _______

SMI: REV ____
(Enter the name of SMI and last five
digits and revision of the number):

FSE 1 Name: Signature:

Date:

FSE 2 Name: Signature:

Date:

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IATD Test Completion Form Workbook

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Workbook Labeling

2.2 Labeling
Test Passed N/A
Check labeling

Check warning label on control panel

FSE Initials:

2.3 Documentation
Test Passed N/A
Check availability of the IfU

Check availability of tube manual

FSE Initials:

2.4 System/Component Design and Performance

Test Passed N/A
Check function of X-ray beam on indicator

Check function of end of exposure indicator

Check function of end of automatic exposure control indicator

Check function of multiple tubes indicator (if applicable)

Source-skin distance for mobile and portable x-ray systems

Test Min. value Measured value Passed N/A
Check source-skin distance ≥ 30 cm _____ cm

Control and indication of technique factors

Test Max. value Measured value Passed N/A
Check maximum mAs 600 mAs _____ mAs

Field indication and alignment

Test Max. value Measured value Passed N/A
Check minimum field size 5 cm × 5 cm _____cm × _____cm

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List of Required Tests Appendix

Test Max. value Measured value Passed N/A

Check alignment of collima-
tor (BLD) light field and X-ray |a1|+ |a2| < 0.02 × SID
field
Check X-ray field alignment
(wall stand vertical beam)
Check X-ray field alignment
(wall stand horizontal beam)
Check X-ray field alignment
(table)
Check actual to indicated
SID
SID = _____mm
|b1|+ |b2| < 0.02 × SID |a1|+ |a2| = _____mm
|b1|+ |b2| = _____mm
|c1|+ |c2| < 0.03 × SID SID = ___mm
|d1|+ |d2| < 0.03 × SID |c1|+ |c2| = _____mm
|c1|+ |c2| + |d1|+ |d2| < |d1|+ |d2| = _____mm
0.04 × SID |c1|+ |c2| + |d1|+ |d2| =
_____mm
SID = _____mm
|c1|+ |c2| = _____mm
|d1|+ |d2| = _____mm
|c1|+ |c2| + |d1|+ |d2| =
_____mm
SID = _____mm
|c1|+ |c2| = _____mm
|d1|+ |d2| = _____mm
|c1|+ |c2| + |d1|+ |d2| =
_____mm
Δ SID ≤ 2 % of SID SID indicated = _____mm
SID measured = _____mm
Δ SID = _____mm

Positive beam limitation (PBL)

Test Passed N/A
Check automatic return to PBL

FSE Initials:

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3 Appendix

3.1 List of Required Tests

Labeling

Labeling
Requirement/Test FDA Section FSE action
CFR 21 Part
Accessible Label for X-ray components 1020.30 (e) Check labeling
with model number, serial number pro-
vided
Accessible Label for tube housing as- 1020.30 (e) (1) Check labeling
sembly with model number, serial num-
ber, manufacturer name provided
Accessible and legible warning state- 1020.30 (j) Check warning label
ment on control panel containing main
power switch provided

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Appendix List of Required Tests

Documentation

Documentation
Requirement/Test FDA Section FSE action
CFR 21 Part / IEC section
Information on generator rated line volt- 1020.30 (g) (1) Check availability of IfU
age, range of line-voltage for opera-
tions at maximum line current provided
Information on maximum line current 1020.30 (g) (2) Check availability of IfU
(based on max. input voltage, current
characteristic of tube housing assem-
bly) provided
Information on technique factors that 1020.30 (g) (3) Check availability of IfU
constitutes maximum line current con-
ditions provided
Instructions for radiological safety pro- 1020.30 (h) (1) (i) Check availability of IfU
vided
Information on schedule of mainte- 1020.30 (h) (1) (ii) Check availability of IfU
nance provided
Statement of maximum deviation from 1020.30 (h) (3) (vi) Check availability of IfU
preindication given by labeled techni-
que factor control or indicators during
exposure provided
A statement describing the measure- 1020.30 (h) (3) (viii) Check availability of IfU
ment criteria for all technique factors
used provided
Information provided on: 1020.30 (h) (2) (i) Check availability of tube
- leakage techniques for tube housing 1020.30 (h) (4) (i) manual
and beam-limiting device, or
- minimum filtration permanently in check availability of IfU
beam (in mm Al equivalent) and peak
tube potential at which Al equivalent
was obtained
Information on cooling curves anode, 1020.30 (h) (2) (ii) Check availability of tube
tube housing provided manual
or
check availability of IfU
Information on tube rating charts for dif- 1020.30 (h) (2) (iii) Check availability of tube
ferent generators (alternate focal spots manual
sizes, speeds of anode) provided or
check availability of IfU
In the case of battery-powered genera- 21 CFR 1020.30 (h)(3)(iv) Check availability of IfU
tors, a specification of the minimum
state of charge necessary for proper
operation.
Information on minimum Al equivalent 1020.30 (h) (4) (ii) Check availability of IfU
for beam passing & suitable X-ray po-
tential for more filters ➜ Al equivalent
of each filter provided

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List of Required Tests Appendix

System/Component design and performance

Requirement/Test FDA Section FSE action
CFR 21 Part
Source to skin distance is ≥ 30 1020.31(i)(2) Check that the source-skin dis-
cm tance ≥ 30 cm.
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Glossary

Glossary

CFR Code of Federal Regulations

FDA Food and Drug Administration

IATD Installation Acceptance Testing Document

IfU Instructions for Use

my_pagecount_text
SMI System Manual for Installation

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