English

Technical Reference Guide

Incisive CT
459801855482_A
 Revision History

Revision Date Reason for Change

459801855481_A 2020/8 Initial Release

459801855481_B 2020/12 Update Information

459801855481_C 2021/3 Update Information

459801855481_D 2021/4 Update Information

459801855481_E 2021/6 Update Information

459801855482_A 2021/8 Update Information

459801855482_A
Philips

All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

Incisive CT Revision History

 Contents

1 Introduction ..................................................................................... 1-1

1.1 About this Guide ..................................................................................1-1

1.2 Caution ................................................................................................1-1
1.3 Compatibility .......................................................................................1-2
1.4 Compliance ..........................................................................................1-2
1.5 IEC-60601 Classification......................................................................1-4
1.6 IEC Statement of Compliance ..............................................................1-5
1.7 Electromagnetic Emissions ...................................................................1-6
1.8 Essential performance ...........................................................................1-6
1.9 Electromagnetic Immunity ...................................................................1-7
1.10 Equipment Cable Requirement...........................................................1-11
1.11 Electrical Ratings ................................................................................1-12
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1.12 Technical Data ...................................................................................1-12

2 Safety ................................................................................................ 2-1

2.1 Important Safety Directions..................................................................2-1

2.2 Emergency Procedures ..........................................................................2-3
Philips

2.3 Electrical Safety and Grounding............................................................2-5

2.4 Mechanical Safety .................................................................................2-5
2.5 Explosion Safety....................................................................................2-6
2.6 Implosion Hazard.................................................................................2-6
2.7 Fire Safety.............................................................................................2-6
2.8 Electromagnetic Compatibility .............................................................2-7
2.9 Radiation Safety..................................................................................2-10
2.10 Oil Leaks ............................................................................................2-12
2.11 Laser Safety.........................................................................................2-12
2.12 Protection Measures ...........................................................................2-13
2.13 System symbols and labels ..................................................................2-14
2.14 Incident Reporting .............................................................................2-24
2.15 Storage and Transportation ................................................................2-24
3 Security of System and Data ............................................................ 3-1

3.1 Regulatory Controls..............................................................................3-2

3.2 Security Issues and Guidelines ..............................................................3-3
3.3 Access Control......................................................................................3-4
3.4 System Application Control..................................................................3-9

Incisive CT Contents i
 3.5 Performing Data Sanitization on Hard Drive .......................................3-9
3.6 3rd party software ...............................................................................3-10
3.7 De-Identified Items ............................................................................3-11
3.8 Software Distribution .........................................................................3-13
4 Image performance quality assurance ............................................. 4-1

4.1 Overview ..............................................................................................4-1

4.2 Head & body system performance phantom .........................................4-2
4.3 Representative quality assurance images ................................................4-5
4.4 Schedule of quality assurance checks .....................................................4-6
5 User information .............................................................................. 5-1

5.1 Overview ..............................................................................................5-1

5.2 Technique factors-maximum deviations................................................5-1
5.3 Gantry laser localizer .............................................................................5-2
5.4 Preventive maintenance.........................................................................5-3
5.5 X-Ray system specifications...................................................................5-6
5.6 CT mean and standard deviation ........................................................5-11
5.7 Dose and imaging information............................................................5-12
5.8 Geometric efficiency in the Z direction...............................................5-24
5.9 IEC stray radiation dose map..............................................................5-24
5.10 Size Specific Dose Estimate (SSDE)....................................................5-25
5.11 Conditions to Achieve 1000 mGy CTDIvol (Peripheral)....................5-30
6 Recycling Passport ........................................................................... 6-1

7 EURATOM Compliance Statement .................................................. 7-1

ii Contents Incisive CT
 1 Introduction

Philips CT systems are advanced continuous-rotation computed

tomography systems suitable for a wide range of computed tomographic
(CT) applications.

1.1 About this Guide

This guide is intended to assist physicists and other personnel in the
quality assurance testing of the CT scanner. It includes physics
information critical to understanding dose, sensitivity, and other scan
information subjects.

This document also includes classifications, ratings, and the hazard labels
and symbols included on your system. You must pay special attention to
all the information given, and procedures described in the Safety and
Security of System and Data sections.
459801855482_A

Before attempting to operate the equipment, you must read, note, and
strictly observe all DANGER notices and safety markings on the CT
System.
Philips

Before attempting to operate the equipment, you must read the

Instructions for Use thoroughly, paying particular attention to all
Warnings, Cautions and Notes incorporated in it.

Note
Review this information carefully; be aware of system-specific
information where applicable.

1.2 Caution
The Philips system should not be used if any of the following conditions
exist or are thought to exist:
• The image performance quality assurance checks (Image
performance quality assurance) have not been satisfactorily
completed.
• The preventative maintenance program is not up-to-date.

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Incisive CT Introduction 1-1

1.3 Compatibility

• If any part of the equipment or system is known

(or suspected to be) operating improperly.

1.3 Compatibility
Equipment described in this manual should not be used in combination
with other equipment or components unless such other equipment or
components are recognized as compatible.

Changes and/or additions to the equipment should only be carried out by

Philips Healthcare or by third parties expressly authorized by Philips
Healthcare to do so. Such changes and/or additions must comply with all
applicable laws and regulations that have the force of law within the
jurisdiction(s) concerned, and with best engineering practice.

Changes and/or additions to the equipment that are carried out by

persons without the appropriate training and/or using unapproved spare
parts may lead to the Philips Healthcare warranty being voided. As with
all complex technical equipment, maintenance by persons not
appropriately qualified and/or using unapproved spare parts carries
serious risks of damage to the equipment and of personal injury.

! Warning
Authorization from the manufacturer must be obtained before
modifying this equipment. After modification, appropriate inspection
and testing must be conducted to ensure continued safe use of the
equipment.

1.4 Compliance
The Philips CT system complies with relevant international and national
standards and laws. Information on compliance will be supplied on
request by your local Philips representative, or by:
Philips Medical Systems, Nederland B.V.
Veenpluis 6
5684 PC Best
The Netherlands

The Philips systems comply with relevant international and national laws
and standards on EMC (electro-magnetic compatibility) for this type of
equipment when used as intended. Such laws and standards define both
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1 -2 Introduction Incisive CT
 Compliance 1.4

the permissible electromagnetic emission levels from equipment and its

required immunity to electromagnetic interference from external
sources.
The Schedule of quality assurance checks identifies the procedures and
frequency of their performance, necessary to ensure (continued)
compliance with the Federal Performance Standards for Diagnostics X-
Ray Equipment, 21 CFR Subchapter J, Radiological Health Section
1020.30 and 1020.33.
Reference IEC 60601-1 Clause 7.9.2.15.

This symbol appears on components on your CT scanner system. It

indicates separate collection for electrical and electronic equipment in
compliance with the Waste Electrical and Electronic Equipment (WEEE)
Directive. The system should be disposed by qualified agency. Please
dispose of the system in accordance with your local regulations to
protect the environment.

California
459801855482_A

In compliance with California’s Best Management Practices for

Perchlorate Materials (California Code of Regulations, title 22, division
4.5, chapter 33, article 1), the following warning applies to all Philips
Healthcare CT scanners and workstations due to Panasonic CR (button)
Philips

batteries that are mounted on printed circuit boards in various parts of

the system:

! Warning
Perchlorate Material – special handling may apply. For more
information, see
www.dtsc.ca.gov/hazardouswaste/perchlorate/index.cfm.

Vermont

In compliance with the labeling requirements of the Vermont labeling law

V.S.A. 10, Chapter 159, §6621(d) and Section 6-803 of the Vermont Solid
Waste Management Rules, this product consists of devices that may
contain mercury, which must be recycled or disposed of in accordance
with local, state, or federal laws. (Within this system, the backlight lamps
in the monitor contain mercury.)

All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

Incisive CT Introduction 1- 3
1.5 IEC-60601 Classification

REACH

REACH (Registration, Evaluation, Authorization and Restriction of

Chemical substances) requires Philips Healthcare (PH) to provide
chemical content information for Substances of Very High Concern
(SVHC) if they are present above 0.1% of the article weight. Components
within electric and electronic equipment may contain phthalates above
the threshold. The SVHC list is updated on a regular basis. Refer to the
following Philips REACH website for the most up-to-date list of products
containing SVHC above the threshold: https://www.philips.com/a-
w/about/sustainability/sustainable-planet/green-operations/reach.html

REACH Declaration related to substances in articles

The table indicates which substances of very high concern (SVHC) may be
present in Philips products above the threshold level of 0.1% by weight of
the listed article. Based on our current knowledge and current supplier
information, no other SVHC are present in our articles.

Philips Product category Substance of Very High Concern CAS Number Comments

Cables and other PVC-based DEHP, bis(2-ethyl(hexyl)phthalate 117-81-7 This substance may be present in separately
components of electric and DIBP, diisobutyl phthalate 84-69-5 sold PVC cables and PVC cables or parts
electronic equipment along with the appliances

Components of electric and Lead 7439-92-1 This substance may be present in e.g., lead
electronic equipment solders, as an alloying element in steel and
aluminium, in galvanised steel components
and in copper alloys (applications exempted
by the EU RoHS Directive 2011/65/EU,
Annexes III and IV). For example, lead in X-
ray shielding.

1.5 IEC-60601 Classification

Reference IEC 60601-1 Clause 7.9.2.1 and 7.9.2.5.

Type of protection against electric shock Class I equipment

Degree of protection against electric shock Type B applied part (patient table)
Type CF applied part (PIM)

Degree of protection against harmful Ordinary equipment (IPX0)

ingress of water Foot switch (IPX1 or better)

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1 -4 Introduction Incisive CT
 IEC Statement of Compliance 1.6

Possible interference with other equipment IEC 60601-1-2 Group 1 Class A

Device for Radiated Emission

Mode of operation Continuous operation with short

time loading (per IEC 60601-1)

1.6 IEC Statement of Compliance

Reference IEC 60601-2-44 Clause 201.4.3 and IEC 60601-1 Clause 4.3.

This CT equipment is compliant to the following standards:

IEC 60601-1: 2005/A1:2012

IEC 60601-1-2: 2014
IEC 62304: 2015
IEC 60601-1-6: 2010/A1:2013
IEC 60601-2-44: 2009/AMD1:2012/AMD2:2016
IEC 62366-1:2015
459801855482_A

This CT equipment with radiation protection in accordance with IEC

60601-1-3:2013.
Philips

All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

Incisive CT Introduction 1- 5
1.7 Electromagnetic Emissions

1.7 Electromagnetic Emissions

The CT scanner is equipped for use in the electromagnetic environment
specified below. Your facility should ensure that the system is placed in an
environment that meets these conditions.

Reference IEC 60601-1-2 clause 5.2.2.1 a.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions, CISPR 11 Group1 Class A The EMISSIONS characteristics of this

equipment make it suitable for use in industrial
areas and hospitals. CT uses RF energy only for
internal function. Therefore, its RF emissions are
very low and not likely to cause any interference
in nearby electronic equipment.

Harmonic Emissions Not Applicable CT is suitable for use in all establishments other
than domestic and those directly connected to
IEC 61000-3-2
the public low-voltage power supply network
Voltage Not Applicable that supplies buildings used for domestic
fluctuations/flicker purposes.
emissions

IEC 61000-3-3

1.8 Essential performance

The Incisive CT essential performance:
• Accuracy of length, area and volume value on images shall be assured.
Measure length, area, volume and scale on images of phantom with
known size
• Continuous CT for interventional procedure
• CCT Single (Interventional Guidance Single): scan each time the X-
ray pedal is depressed.
• CCT Continuous (Interventional Guidance Continuous): sequential
axial scans as long as the pedal is being pressed.

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1 -6 Introduction Incisive CT
 Electromagnetic Immunity 1.9

1.9 Electromagnetic Immunity

Reference IEC 60601-1-2 clause 5.2.2.1, 5.2.2.5 a and 5.2.2.5 c.

The CT scanner is equipped for use in the electromagnetic environment

specified below. Your facility should ensure that the system is placed in an
environment that meets these conditions.

Immunity Test IEC 60601 test level Compliance level Electromagnetic

environment-guidance

Conducted RF 3 Vrms 3 Vrms Only those cables supplied with

IEC 61000-4-6 150 kHz to 80 MHz on a.c. power and signal the CT system should be used.
ports
150 kHz to 80 MHz

6 Vrms
on a.c power and signal
ports in ISM bands 150
kHz to 80 MHz
See Note 3 for list of
ISM bands
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Radiated RF 3 V/m 3 V/m Interference may occur in the

IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz vicinity of equipment marked
80% AM at 1 kHz with the following symbol:
Philips

Proximity fields from 380 MHz – 5800 MHz 380 MHz - 5800 MHz
RF wireless see Notes 4“Test specifications for ENCLOSURE PORT
communications IMMUNITY
equipment to RF wireless communications equipment”
IE61000-4-3

Note 1 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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Incisive CT Introduction 1- 7
1.9 Electromagnetic Immunity

Note 2 Only the equipment specified in the CT Installation Manual may be used inside the gantry and patient table
room.
Note 3 The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio
bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz
to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz,
24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Note 4 See the table Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment.
Note 5 Incisive CT is a PERMANENTLY INSTALLED LARGE ME SYSTEM, the tested for radiated RF IMMUNITY
over the entire frequency range 80 MHz to 6 000 MHz can be exempt.

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1 -8 Introduction Incisive CT
 Electromagnetic Immunity 1.9

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications

equipment.
Test Banda Servicea Modulationb Maximum Distance IMMUNITY
frequency (MHz) power (m) TEST
(MHz) (W) LEVEL
(V/m)

385 380-390 TETRA 400 Pulse modulationb 18 Hz 1.8 0.3 27

450 430-470 GMRS 460, FRS FM± 5 kHz deviation 1 kHz 2 0.3 28
c
460 sine

710 704-787 LTE Band 13, 17 Pulse modulationb 217 Hz 0.2 0.3 9

745

780

810 800-960 GSM 800/900, Pulse modulationb 18 Hz 2 0.3 28

TETRA 800,
870
iDEN 820,
930 CDMA 850,
LTE Band 5

1720 1700- GSM 1800; Pulse modulationb 217 Hz 2 0.3 28

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1990 CDMA 1900;

1845
GSM 1900;
1970 DECT;
LTE Band 1, 3,
4, 25; UMTS
Philips

2450 2400- Bluetooth, Pulse modulationb 217 Hz 2 0.3 28

2570 WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7

5240 5100- WLAN 802.11 Pulse modulationb 0.2 0.3 9

5800 a/n 217 Hz
5500

5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the
Incisive CT may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.

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Incisive CT Introduction 1- 9
1.9 Electromagnetic Immunity

Immunity IEC 60601 Compliance Electromagnetic environment-

Test test level level guidance

Electrostatic ±6 kV contact ±8 kV contact Floors should be wood, concrete or

discharge ±8 kV air ±15 kV air ceramic tile. If the floors are covered
(ESD) with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 35% non-
condensing per the CT planning
reference data (PRD).

Electrical fast ±2 kV for power ±2 kV for power Main’s power quality must comply
transient/burst supply lines mains input with the CT planning reference data
IEC 61000-4-4 ±1 kV for ±1 kV for signal (PRD).
input/output ports
lines 100kHz
repetition
frequency

Surge ±1 kV lines to ±1 kV differential Main’s power quality must comply

IEC 61000-4-5 lines ±2 kV common with the CT planning reference data
±2 kV lines to mode (PRD).
earth

Voltage dips, Not Applicable Not Applicable Main’s power quality must comply
and voltage with the CT planning reference data
variations on (PRD).
power supply
input lines IEC If the user of the CT requires
61000-4-11 continued operation during power
mains interruptions, it is
Voltage 0% UT; 250/300 0% UT; 250/300
recommended that the CT be
interruptions cycle cycle
powered from an uninterruptible
and voltage UT is the AC
power supply.
variations on mains voltage
power supply prior to
input lines IEC application of the
61000-4-11 test level.

Power 30 A/m 30 A/m, Power frequency magnetic fields

frequency 50/60 Hz should be at levels characteristic of a
(50/60 Hz) typical location in a typical commercial
magnetic field or hospital environment.
IEC 61000-4-8

Reference IEC 60601-1-2 Clause 5.2.2.5 b.

! Warning
This equipment has been tested for radiated RF immunity only at
selected frequencies, and use nearby of emitters at other frequencies
could result in improper operation.

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1 -1 0 Introduction Incisive CT
 Equipment Cable Requirement 1.10

1.10 Equipment Cable Requirement

Reference IEC 60601-2-44 Clause 201.4.10.2, IEC 60601-1 Clause 7.9.3.1,
and IEC 60601-1-2 Clause 5.2.1.1 d.
Power cable

No. Name Length (m) Shielding Note

1 Power cable 16.6 No Three-phase Fve-wire, 16mm2

Signal cable, interconnection cables or patient coupling cables.

No. Name Length (m) Shielding From To Note

2 Gantry to Console PE cable 23 No Gantry Console

3 UPS power cable 23 No Gantry Console

4 optical fiber gantry to 27 No Gantry Console Signal cable

console

5 Network cable gantry to 23 Yes Gantry Console Signal cable

console

6 Gantry interface board to 23 Yes Gantry Console Signal cable

DRC card
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7 Gantry to console interface 23 Yes Gantry Console Signal cable

board

8 Mobile monitor power cable 15 No Gantry Mobile monitor 2 cables

9 Camare power cable 15 No Gantry Camera Kit

10 IVC controller to Gantry 6 Yes Gantry IVC controller Signal cable

Philips

cable

11 Power cable of mobile 23 No Gantry Mobile monitor

monitor on ceiling

12 PE cable of mobile monitor 23 No Gantry Mobile monitor

on ceiling cart

13 Camera USB3.0 cable 25 Yes Console Camera Kit Signal cable

14 DP monitor optical fiber 30 No Console Mobile monitor Signal cable

cable

15 CT Box control cable 2.9 Yes Console CT Box Signal cable

16 PIMdata cable 3.5 Yes Gantry PIM Signal cable

17 CCT foot switch cable 5 Yes Gantry CCT foot switch Signal cable

18 USB cable for IVC interface 30 Yes Gantry Console Signal cable
board to Console

19 UPS output line 2 No UPS Monitor 3 cables

Cables and component should be replaced by Customer Service.

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Incisive CT Introduction 1- 11
1.11 Electrical Ratings

1.11 Electrical Ratings

Reference IEC 60601-1 Clause 7.9.2.3.

Power supply type 380/400 VAC, 3-phase

Power capacity 115 kVA

Frequency 50/60 Hz

Rated voltage 380/400 V

Maximum voltage fluctuation 90% ~ 110%

1.12 Technical Data

Reference IEC 60601-2-44 Clause 201.7.9.2.9.

55 kW

The corresponding nominal X-ray tube voltage 80 kV, 667mA

together with the highest X-ray tube current
obtainable from the high voltage generator
when operated at that X-ray tube voltage.

The corresponding highest X-ray tube current 140 kV, 392 mA

together with the highest X-ray tube voltage
obtainable from the high voltage generator
when operated at that X-ray tube current.

The corresponding combination of X-ray tube 140 kV, 392 mA@55 kW

voltage and X-ray tube current which results 120 kV, 458 mA@55 kW
in the highest electric output power. 100 kV, 550 mA@55 kW

The nominal electric power given as the 55 kW

highest constant electric output power in
kilowatts which the high-voltage generator can
deliver, for a loading time of 4 s at an X-ray
tube voltage of 120 kV, 458mA.

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1 -1 2 Introduction Incisive CT
 Technical Data 1.12

72 kW

The corresponding nominal X-ray tube voltage 100 kV, 667mA

together with the highest X-ray tube current
obtainable from the high voltage generator
when operated at that X-ray tube voltage.

The corresponding highest X-ray tube current 140 kV, 514 mA

together with the highest X-ray tube voltage
obtainable from the high voltage generator
when operated at that X-ray tube current.

The corresponding combination of X-ray tube 140 kV, 514 mA@72 kW

voltage and X-ray tube current which results 120 kV, 600 mA@72 kW
in the highest electric output power.

The nominal electric power given as the 72 kW

highest constant electric output power in
kilowatts which the high-voltage generator can
deliver, for a loading time of 4 s at an X-ray
tube voltage of 120 kV, 600mA.

80 kW

The corresponding nominal X-ray tube voltage 120 kV, 667mA

459801855482_A

together with the highest X-ray tube current

obtainable from the high voltage generator
when operated at that X-ray tube voltage.

The corresponding highest X-ray tube current 140 kV, 571 mA

together with the highest X-ray tube voltage
Philips

obtainable from the high voltage generator

when operated at that X-ray tube current.

The corresponding combination of X-ray tube 140 kV, 571 mA@80 kW

voltage and X-ray tube current which results 120 kV, 667 mA@80 kW
in the highest electric output power.

The nominal electric power given as the 80 kW

highest constant electric output power in
kilowatts which the high-voltage generator can
deliver, for a loading time of 4 s at an X-ray
tube voltage of 120 kV, 667 mA.

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Incisive CT Introduction 1- 13
 2 Safety

2.1 Important Safety Directions

Philips Healthcare products are all designed to meet stringent safety
standards. However, all medical electrical equipment requires proper
operation and maintenance, particularly with regard to human safety.

It is vital that you read, note, and where applicable, strictly observe all
DANGER notices and safety markings on the CT system.

It is vital that you follow strictly all safety directions under the heading
Safety and all Warnings and Cautions throughout this Instructions
for Use to help ensure the safety of both patients and operators.

In particular, you must read, understand and know the Emergency

Procedures described in this Safety section before attempting to use
459801855482_A

the equipment for any patient examination.

You should also note the information given in the Introduction section
of this Technical Reference Guide and Instructions for Use.
Philips

! Warning
The X-ray unit may be dangerous to patient and operator unless safe
exposure factors, operating instructions, and maintenance schedules
are observed.

! Warning
Do not use the CT system for any application until you are sure that
the Image Performance Quality Assurance has been satisfactorily
completed, and that the Preventative Maintenance Program is up to
date. If any part of the equipment or system is known (or suspected)
to be operating improperly or wrongly-adjusted, DO NOT USE the
system until a repair has been made.

! Warning
Operation of the equipment or system with improperly-operating or
wrongly-adjusted components could expose the operator or the
patient safety hazards. This could lead to fatal or other serious
personal injury.

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Incisive CT Safety 2-1

2.1 Important Safety Directions

You can find information about the Image Performance Quality Assurance
and the Preventative Maintenance Program in the Image performance
quality assurance and User information headings.

! Warning
Do not use the CT system for any application until you have read,
understood and know all the safety information, safety procedures
and emergency procedures contained in this SAFETY section.
Operation of the CT system without a proper awareness of how to
use it safely could lead to fatal or other serious personal injury.

! Warning
Do not use the CT system for any application until you have received
adequate and proper training in its safe and effective operation. If you
are unsure of your ability to operate this equipment safely and
effectively DO NOT USE IT. Operation of this equipment without
proper and adequate training could lead to fatal or other serious
personal injury. It could also lead to clinical misdiagnosis.

For information about training, please refer to Training in the

Introduction section of Instructions for Use.

! Warning
Never attempt to remove, modify, over-ride or forcibly move any
safety device on the equipment. Interfering with safety devices could
lead to fatal or other serious personal injury.

! Warning
Do not use the CT system for any purpose other than those for which
it is intended. Operation of the CT system for unintended purposes,
or with incompatible equipment, could lead to fatal or other serious
injury. It could also lead to clinical misdiagnosis.

Intended purpose of the CT system is described under the heading

Intended purpose in the Introduction section of Instructions for
Use. Compatibility is discussed under the heading Compatibility in the
Introduction section of this Technical Reference Guide.

Reference IEC 60601-1 Clause 7.9.3.1.

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2 -2 Safety Incisive CT
 Emergency Procedures 2.2

! Warning
• Do not modify this equipment without authorization from the
manufacturer.
• No modification of this equipment is allowed.
• If this equipment is modified, appropriate inspection and testing
must be conducted to ensure continued safe use of the equipment.

2.2 Emergency Procedures

2.2.1 Emergency Stop

To bring scanner and Patient table movements and X-ray production to
an immediate halt, press one of the red Stop buttons. One button is
located on the Scan control box, and one on each gantry control panel.

2.2.2 Reset from Emergency Stop

Use this procedure to reset from emergency stop:
459801855482_A

1 Locate the button that was pressed to initiate the stop.

2 Press the button to disengage it from the stop position.
3 Restart the gantry.
Philips

4 Relaunch the host application.

! Warning
After the Stop button is pressed, the table is locked in place for two
seconds before it is movable. You must maintain control of the table.

! Warning
During all movements of the gantry (automatic and manual) and the
patient table, keep the patient under continuous observation to avoid
patient falling and pressing the patient against the gantry or between
table parts, as well as to avoid disconnecting any infusion or
resuscitation apparatus.

! Warning
Make sure that the motion of the table is in the direction that will
ensure that the patient can be easily released and will not get pressed
against the gantry covers.

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Incisive CT Safety 2- 3
2.2 Emergency Procedures

2.2.3 Emergency Patient Release

Reference IEC 60601-2-44 Clause 201.9.2.5.101.

If the patient’s head is lying on one side of the gantry opening and the
trunk and legs are lying on the other side of the opening, the patient
should be released in the direction of the legs.

If the head is likely to touch the roof of the gantry opening, lower the
head by removing the head support or the pillow, and turn the head to
the side before moving the patient table.

To release the patient in the event of a power failure or in an

emergency stop situation, use one of the following procedures:

Pulling the Patient Out

1 Grasp the handle at the end of the patient table.
2 If the patient can safely be pulled out, pull the patient table out.
3 Help the patient dismount.

Pushing the Patient In

1 Grasp the handle at the end of the patient table.
2 If the patient can be safely pushed in, push the patient table towards
the back of the gantry.
3 Help the patient dismount.

Note
• In the event of a power failure or emergency stop, the patient table
does not move vertically. Be prepared to help the patient from the
table.
• When the emergency stop button is pressed, the tilt angle of gantry
would be less than 0.5 degree and table stopped in 10 mm (when
patient weight is 135kg). (Reference IEC 60601-2-44 Clause
201.9.2.3.1.102.)

All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

2 -4 Safety Incisive CT
 Electrical Safety and Grounding 2.3

2.3 Electrical Safety and Grounding

! Warning
• Do not remove covers or cables from this equipment. High
electrical voltages are present within this equipment. Removing
covers or cables could lead to serious or fatal personal injury.
• To avoid risk of electric shock, do not cut cables.
• To avoid risk of electric shock, make sure that there is no
movement run over the cables.
• Visual inspection of cables before use is necessary to avoid risk of
electric shock, if any defects are found please contact Customer
Service.
• Be careful of cables on the floor to avoid tripping of personnel.

Covers or cables should only be removed by qualified and authorized

service personnel.

Only use this equipment in rooms or areas that comply with all applicable
laws (or regulations have the force of law) concerning electrical safety for
this type of equipment.
459801855482_A

The equipment must be grounded to an earth ground by a separate

conductor. The neutral side of the line is not to be considered the earth
ground. On equipment provided with a line cord, the equipment must be
Philips

connected to a properly grounded, three-pin receptacle. Do not use a

three-to-two pin adapter.

! Warning
Reference IEC 60601-1 Clause 7.9.2.2.
To avoid risk of electric shock, this equipment must be connected to a
supply mains with protective earth. The neutral side of the line is not
to be considered the earth ground. An additional MULTIPLE
SOCKET-OUTLET or extension cord shall not be connected to the
system.

2.4 Mechanical Safety

! Warning
• Do not remove covers from this equipment. Removing covers could
lead to serious or fatal personal injury.

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Incisive CT Safety 2- 5
2.5 Explosion Safety

• Operate this equipment carefully to avoid injury to the patient,

table cover, and gantry cover.

Covers should only be removed by qualified and authorized service

personnel.

2.5 Explosion Safety

This equipment must not be used in the presence of explosive gases or
vapors, such as certain anaesthetic gases. Use of electrical equipment in
an environment for which it was not designed can lead to fire or
explosion.

! Warning
Flammable or potentially explosive disinfecting sprays must not be
used, since the resultant vapor could ignite, causing fatal or other
serious personal injury and/or damage to equipment.

2.6 Implosion Hazard

! Warning
Do not subject the system to serious mechanical shock, as the
cathode ray tube (CRT) can fracture if struck or jarred. This may
result in flying pieces of glass and phosphor coating that can cause
serious injury.

2.7 Fire Safety

Use of electrical equipment in an environment for which it was not
designed can lead to fire or explosion.

Conductive fluids that seep into the active circuit components of the
operator’s console may cause electric shock and/or short circuits that can
result in electrical fires. Therefore, do not place any liquid or food on any
part of the consoles or other modules of the system.

Fire regulations for the type of medical area being used should be fully
applied, observed and enforced. Fire extinguishers should be provided for
both electrical and non-electrical fires.

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2 -6 Safety Incisive CT
 Electromagnetic Compatibility 2.8

All operators of this medical electrical equipment should be fully aware of

and trained in the use of fire extinguishers and other fire-fighting
equipment, and in local fire procedures.

! Warning
Only use extinguishers on electrical or chemical fires which are
specifically labelled for those purposes. Using water or other liquids
on an electrical fire can lead to fatal or other serious personal injury.

If it is safe to do so, attempt to isolate the equipment from electrical and

other supplies before attempting to fight a fire. This will reduce the risk of
electric shocks.

2.8 Electromagnetic Compatibility

The Philips CT system complies with the requirements of applicable EMC
standards (Refer to Electromagnetic Emissions, on page 1-6 and
Electromagnetic Immunity, on page 1-7).
459801855482_A

! Warning
Reference IEC 60601-1-2 clause 5.2.1.1 c.
• Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
Philips

such use is necessary, this equipment and the other equipment

should be observed to verify that they are operating normally.
Reference IEC 60601-1-2 clause 5.2.1.1 e.
• Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.

Note
Reference IEC 60601-1-2 clause 5.2.1.2
• The EMISSIONS characteristics of this equipment make it suitable
for use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residential environment (for which CISPR 11 class B is
normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-
orienting the equipment.

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Incisive CT Safety 2- 7
2.8 Electromagnetic Compatibility

2.8.1 Mobile Telephones and Similar Products

Other electronic equipment exceeding the limits defined in such EMC
standards, such as certain mobile telephones, could affect the operation
of the CT system.

! Warning
Reference IEC 60601-1-2 clause 5.2.1.1 F.
• Portable RF communications equipment (including accessories such
as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the Incisive CT, including
cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.

2.8.2 Electronic and Implanted Stimulators

The FDA Preliminary Public Health Notification: Possible Malfunction of
Electronic Medial Devices Caused by Computed Tomography (CT)
Scanning, July 14, 2008, advises that with any CT scanner, there is a
possibility that the X-rays used during CT examinations may cause some
implanted and external electronic medical devices (pacemakers,
defibrillators, neurostimulators, and drug infusion pumps) to malfunction.

Philips recommends that users check the device manufacturer's

recommendations/precautions regarding use in a CT Scanner. Further,
the FDA recommendations (summarized below) should be followed.

Recommendations prior to scan:

1 Ask the patient if he/she has any implanted or external electronic
medical devices.
2 Use CT Surview scans to determine if implanted or externally worn
electronic medical devices are present and if so, their location relative
to the programmed scan range.
3 For CT procedures in which the medical device is in, or immediately
adjacent to, the planned scan range, make these adjustments:
• Determine the device type.
• If practical, try to move external devices out of the scan range.
• Ask patient with a neurostimulator to shut off the device
temporarily while the scan is performed.
• Minimize X-ray exposure to the implanted or externally worn
electronic medical device by using the lowest possible X-ray tube

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2 -8 Safety Incisive CT
 Electromagnetic Compatibility 2.8

current consistent with obtaining the required image quality, and

making sure that the X-ray beam scans over the device for less than
a few seconds.

Note
For CT procedures that require scanning over the medical device for more
than a few continuous seconds (as with CT perfusion or interventional exams)
users should prepare to treat possible adverse reactions.

Recommendations after scan:

1 Have the patient turn the device back on if it had been turned off
prior to scanning.
2 Have the patient check the device for proper functioning.
3 Advise the patient to contact his/her health care provider as soon as
possible if he/she suspects the device is not functioning properly after
a CT scan.
459801855482_A
Philips

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Incisive CT Safety 2- 9
2.9 Radiation Safety

2.9 Radiation Safety

X-ray and gamma rays are dangerous to both operator and others in the
vicinity unless established safe exposure procedures are strictly observed.

The useful and scattered beams can produce serious or fatal bodily
injuries to patients and persons in the surrounding area if used by an
unskilled operator. Adequate precautions must always be taken to avoid
exposure to the useful beam, as well as to leakage radiation from within
the source housing or to scattered radiation resulting from passage of
radiation through matter.

Those authorized to operate, participate in or supervise the operation of

the equipment must be thoroughly familiar and comply completely with
the current established safe exposure factors and procedures described
in publications, such as the “Diagnostic X-ray systems and their major
components,” section of subchapter J of Title 21 of the Code of Federal
Regulations, and the National Council on Radiation Protection (NCRP)
No. 102, “Medical X-ray and gamma ray protection for energies up to 10
MEV equipment design and use,” as revised or replaced in the future.

Operators are strongly urged to comply with the current

recommendations of the International Commission on Radiological
Protection, or in Japan, the Medical Law and its enhanced regulations, or
in the United States, with those of the US National Council for
Radiological Protection.
• ICRP, Pergamon Press, Oxford, New York, Beijing, Frankfurt, Sao
Paulo, Sydney, Tokyo, Toronto
• NCRP, Suite 800, 7910 Woodmont Avenue, Bethesda, Maryland
20814, USA

Individuals responsible for the planning of X-ray and gamma ray

equipment installations must be thoroughly familiar and comply
completely with NCRP No. 49, “Structural shielding design and evaluation
for Medical of X-rays and gamma rays of energies up to 10 MEV,” as
revised and replaced in the future.

In Japan, users should refer to Medical Law and its enhanced regulations,
Laws Concerning the Prevention from Radiation Hazards due to
Radioisotopes and Others and its enhancement regulations, Industrial

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2 -1 0 Safety Incisive CT
 Radiation Safety 2.9

safety and Health Law, Laws Concerning the Prevention from Electrical
Dissociation Radiation Hazards, Ordinance by Local Government on Fire
Prevention and Dangerous Article.

Failure to observe these warnings may cause serious or fatal bodily

injuries to the operator or those in the area.

WARNING: This X-ray unit may be

dangerous to patient and operator unless
safe exposure factors, operating instructions
and maintenance schedules are observed.

2.9.1 Radiation Indicators

The radiation indicators on the gantry panels, on the scan control panel,
as well as site radiation indicators, must light up if scanning has been
triggered.

If a radiation indicator does not light up:

459801855482_A

• Shut down the system immediately and contact Customer Service.

• Press the Emergency Stop button if there is danger to you or the
patient.
Philips

2.9.2 Installation and Environment

Except for installations requiring certification by the manufacturer per
United States Federal Performance Standard, see that a radiation
protection survey is made by a qualified expert in accordance with NCRP
012, Section 7, as revised or replaced in the future.

Perform a survey after every change in equipment, workload or operating

conditions which might significantly increase the probability of persons
receiving more than the maximum permissible dose equivalent. In Japan,
report the installation to the Competent Authority.

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Incisive CT Safety 2- 11
2.10 Oil Leaks

2.10 Oil Leaks

The X-ray tube and high-voltage generator are cooled by oil. This is a
closed-circuit system that is sealed.

! Caution
If oil leaks are detected, shut down the scanner and immediately
contact the nearest Philips field service office.

2.11 Laser Safety

! Warning
• Laser radiation.
• Do not stare into laser beam when you use of optical instruments,
such as eyeglasses with large diopter or mirrors. The laser light can
cause eye damage.
• 1M laser production.

Label / Symbol Description

CAUTION: Radiation hazard.

Laser Radiation
Do not expose users of telescopic optics
class 1M laser product <0.39mW, output:
λ=650nm
Acc.IEC 60825-1:2014
Complies with FDA 21
CFR1040.10&1040.11 except for deviation
pursuant to laser notice NO.50 dated June
24,2007

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2 -1 2 Safety Incisive CT
 Protection Measures 2.12

2.12 Protection Measures

Take the following protection measures to protect both yourself and the
patient.

Anyone who has to be near the patient during scanning must wear
protective clothing (lead apron), wear a PEN dosimeter and/or film
badge, and stay in the zone shielded by the system (to the side of the
gantry or behind a mobile protective wall).

The physician is responsible for protecting the patient from unnecessary

radiation.
• Always use a gonadal shield, if possible.
• Use the applicable protocols for children.

Recommendation for the use of specific area gonad shielding on patients

during medical diagnostic x-ray procedures.

Specific area gonad shielding covers an area slightly larger than the region
459801855482_A

of the gonads. Such shielding should be provided when the following

conditions exist:
• The gonads will lie within the primary x-ray field, or within close
proximity (about 5 centimeters), despite proper beam limitation.
• Specific area testicular shielding should always be used during those
Philips

examinations in which the testes usually are in the primary x-ray

field, such as examinations of the pelvis, hip, and upper femur;
• Specific area testicular shielding may also be warranted during other
examinations of the abdominal region in which the testes may lie
within or in close proximity to the primary x-ray field, depending
upon the size of the patient and the examination techniques and
equipment employed.
• Specific area gonad shielding should never be used as a substitute for
careful patient positioning, the use of correct technique factors and
film processing, or proper beam limitation (confinement of the x-ray
field to the area of diagnostic interest).
• Specific area gonad shielding should provide attenuation of x-rays at
least equivalent to that afforded by 0.25 millimeter of lead.
• The clinical objectives of the examination will not be compromised.
• Specific area testicular shielding usually does not obscure needed
information except in a few cases such as oblique views of the hip,
retrograde urethrograms and voiding cystourethrograms,
visualization of the rectum and, occasionally, the pubic symphysis.
• The use of specific area ovarian shielding is frequently impractical at
present because the exact location of the ovaries is difficult to
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Incisive CT Safety 2- 13
2.13 System symbols and labels

estimate, and the shield may obscure visualization of portions of

adjacent structures such as the spine, ureters, and small and large
bowels.
• The patient has a reasonable reproductive potential.
• Specific area shielding need not be used on patients who cannot or
are not likely to have children in the future.
• The following table of statistical data regarding the average number
of children expected by potential parents in various age categories
during their remaining lifetimes is provided for x-ray facilities that
wish to use it as a basis for judging reproductive potential:

Age Male parent Female parent

Fetus 2.6 2.6

0 to 4 2.6 2.5

5 to 9 2.7 2.5

10 to 14 2.7 2.6

15 to 19 2.7 2.6

20 to 24 2.6 2.2

25 to 29 2.0 1.4

30 to 34 1.1 .6

35 to 39 .5 .2

40 to 44 .2 .04

45 to 49 .07 0

50 to 54 .03 0

55 to 64 .01 0

Over 65 0 0

2.13 System symbols and labels

Reference IEC 60601-1 Clause 7.9.3.1.

These symbols may be included on system labeling:

Fragile Content Upwards positioning

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2 -1 4 Safety Incisive CT
 System symbols and labels 2.13

Waterproof Package Center of gravity

Stack Limiter/Layer Do not stack

Limitation

Lift from here Atmospheric pressure limitation

Temperature limitation Humidity limitation

Serial number Manufacturer

Gantry front Couch head

459801855482_A

These labels may be included on the system components:

Follow all warnings included on product labeling as well as those included

Philips

in this manual.

Refer to user instructions

Refer to user instructions

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Incisive CT Safety 2- 15
2.13 System symbols and labels

Reference IEC 60601-2-44 Clause

201.7.9.2.2.
Caution: Crushing hazard (hand)

Caution: Crushing hazard (foot)

Caution: Crushing hazard (hand). Do not

grasp side of the cradle.

Caution: Sitting prohibited. Weight limit.

ESD (electrostatic discharge): The product

is marker with this symbol to warn the user
not to touch exposed pins. Touching
exposed pins can cause electrostatic
discharge, which can damage the product.

Table: Maximum weight capacity is less than

or equal to 205 kg.

Table: Maximum weight capacity is less than

or equal to 307 kg.

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2 -1 6 Safety Incisive CT
 System symbols and labels 2.13

Extension: Maximum load capacity is less

than or equal to 24 kg (53 lb).

Caution: Keep screen dry and clean.

WARNING: Do not scan this area.

This side up. Remove arm rest before

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scanning.
Philips

Left and right side of therapy top.

WARNING: Be aware of possible pinch
points between the therapy top and the
gantry. Two person lift required.

Maximum load capacity is less than or equal

to 285 kg

CAUTION: Hand pinch point or crush

hazard.

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Incisive CT Safety 2- 17
2.13 System symbols and labels

End of therapy top.

WARNING: Do not scan this area.

Caution: Crushing hazard (Leg)

Warning: Do not lean against the floating

sensors which are located at the rear end of
both table sides and rear handle, to avoid
unintentional activation of the floating mode.

! Warning
• Make sure the system and the scan room comply with operational
requirements before initiating the system.
• Take care to avoid fingers, arms, clothing, infusion or life support
devices drawn into moving parts of couch, and cause serious injury
to patient.
• To avoid people injury, which are caused by table and extension
breakage/disconnection, please pay attention to the maximum table
weight and maximum foot extension load capacity.

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2 -1 8 Safety Incisive CT
 System symbols and labels 2.13

Use the following information to interpret the symbols used on the

system and accessories.
ISO 7000-0434A Caution To indicate that caution is necessary
when operating the device or control
close to where the symbol is placed,
or to indicate that the current
situation needs operator awareness
or operator action in order to avoid
undesirable consequences.

ISO 7000-1641 Operator's To identify the location where the

manual; operator's manual is stored or to
operating identify information that relates to the
instructions operating instructions. To indicate
that the operating instructions should
be considered when operating the
device or control close to where the
symbol is placed.

IEC 60417-6042 Caution, risk of Identifies equipment that has risk of

electric shock electric shock, for example the power
source.
459801855482_A

IEC 60417-5638 Emergency stop Identifies an emergency stop control

device. Found on the red buttons
located on the gantry and the System
Scan Control Box.
Philips

N/A Electronic Identifies the website address to

Instructions for access the electronic version of the
Use instructions for use (eIFU).

ISO 7010-M002 Refer to Signifies that the instruction

instruction manual/booklet must be read and the
manual/booklet warnings and instructions therein
followed.

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Incisive CT Safety 2- 19
2.13 System symbols and labels

IEC 60417-5840 Type B applied Identifies a type B applied part

part complying with IEC 60601-1.

ISO 7000-5390 Patient, normal; Indicates a reference to a normal

person, general patient, or to indicate a person and
human body.

IEC 60417-5335 Type CF applied Identifies a type CF applied part

part complying with IEC 60601-1.

IEC60825-1 Laser Warning Indicates potential harm from the

label presence of a laser beam or radiation
from the laser apparatus.

ISO 7000-5339 Emitting X-ray Indicates the emission or the

source assembly imminent emission of X-radiation.

ISO 7000-2497 Date of The date when the medical device was
manufacture manufactured. The associated date is
presented in YYYY-MM-DD format.

ISO 7000-3082 Manufacturer Indicates the medical device

manufacturer (i.e. the entity placing
the medical device on the market).

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2 -2 0 Safety Incisive CT
 System symbols and labels 2.13

IEC 60417-6049 Country of Identifies the country of manufacture

IEC TR 60878- manufacture using the two letter country code
6049 defined in ISO 3166-1 represented by
“CN” in this example.

ISO15223-1 Authorized Indicates the authorized

representative representative in the European
in the European Community
Community

N/A Medical Device Indicates that the item is a medical

device.

IEC 60417-6050 Model Indicates the product model.

459801855482_A

ISO 7000-2498 Serial number Indicates the manufacturer's serial

number so a specific medical device
Philips

can be identified.

ISO 7000-2493 Catalogue Indicates the manufacturer's catalog

number number so that the medical device can
be identified.

N/A Unique Device Indicates the Unique Device Identifier

Identifier Information

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Incisive CT Safety 2- 21
2.13 System symbols and labels

ISO 7010-P019 No stepping on Indicates the surface is unsuitable for

surface stepping onto.

ISO 7010 - Warning; Take care to avoid injury to hands

W024 Crushing of when in the vicinity of equipment
hands with closing mechanical parts.

IEC 60417 - Protective earth Identifies any terminal which is

5019 (ground) intended for connection to an
external conductor for protection
against electric shock in case of a fault,
or the terminal of a protective earth
(ground) electrode.

IEC 60417 - Earth; ground Identifies an earth (ground) terminal in

5017 cases where neither the symbol 5018
nor 5019 is explicitly required.

IEC 60417 - Non-ionizing Indicates medical electrical equipment

5140 electromagnetic or systems that include RF
radiation transmitters or that intentionally apply
RF electromagnetic energy for
diagnosis or treatment; or to indicate
elevated, potentially hazardous, levels
of non-ionizing radiation.

IEC 60417-5264 ON (Power) To indicate the “ON” condition.

IEC 60417-5265 OFF (Power) To indicate the “OFF” condition.

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2 -2 2 Safety Incisive CT
 System symbols and labels 2.13

N/A Product complies with the

requirements of the applicable
C0123 European Union directives.

CSA This product complies with standards

certification of CSA certification in United States
and Canada.

N/A This product is available by

Prescription only.
459801855482_A

China Product complies with the

Compliance requirements of the applicable China
Certification Compliance Certification.
Philips

ANSI Z535.2- Radiation.

2011

Unique Device Identification Label

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Incisive CT Safety 2- 23
2.14 Incident Reporting

Number Description

1 Manufacturer address

2 Model

3 Reference or catalog number

4 Serial number

5 Global Trade Identification Number (GTIN) as Device Identifier

(DI) and Production Identifier (PI).

6 Unique Device Identifier

7 Unique Device Identification GS1 2D DataMatrix barcode

(contains information from 5).

8 Electrical rating specific to system

9 Authorized representative in the European Community

10 Country of manufacture

11 Month and year of device manufacture as per 21 CFR.

12 Product complies with the requirements of the applicable

European Union directives.

2.14 Incident Reporting

Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the
Member State in which the user and/or patient is established.

2.15 Storage and Transportation

Temperature Relative humidity Air pressure

Storage -15°C ~ 45°C 20% ~ 80% (no condensing) 50 - 106 kPa

(Max. Gradient:
10 °C/ Hour)

Transportation -20°C ~ 50°C 20% ~ 80% (no condensing) 50 - 106 kPa

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2 -2 4 Safety Incisive CT
 3 Security of System and Data

Philips Healthcare is dedicated to helping you maintain the confidentiality,

integrity, and availability of electronic protected health information and
the hardware and software products that create and manage these data.

Maintaining security of Philips Healthcare’s products should be an

important part of your facility's security-in-depth strategy. You should
implement a comprehensive, multi-layered strategy (including policies,
processes, and technologies) to protect information and systems from
external and internal threats. Your security strategy should follow
industry-standard practices, addressing physical security, personnel
security, procedural security, risk management, security policies, and
contingency planning.

The practical implementation of technical security elements varies by site

and may employ a number of technologies, including firewalls, virus
scanning software, authentication technologies, etc. As with any
459801855482_A

computer-based system, protection must be provided such that firewalls

and/or other security devices are in place between the medical system
and any externally accessible systems. These perimeter and network
defences are essential to good security practice.
Philips

This chapter provides guidelines to help the operator and owner

understand the possible ways security can be compromised, and then
insure that safeguards are in place to prevent this from happening. For
specific information about security within their institutions, operators and
owners can consult with the following offices at their location:
• Information Systems Security Officer
• Chief Information Officer
• HIPAA Officer (in the U.S.A.)
• Safety Officer

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Incisive CT Security of System and Data 3-1

3.1 Regulatory Controls

3.1 Regulatory Controls

Protect Patient’s Health Information

One of the most important assets to protect with security measures is

the patient’s health related information. Many governments require
maintaining the confidentiality of this information.

Therefore, strict security measures must be taken to guard this protected

information.

Note
De-identify patient studies when exporting via network or removable
media, in compliance with your local privacy policies. See “De-Identify
Patient” in the Instructions for Use for more information.

Prevent Unauthorized Device Modification

Philips Healthcare sells highly complex medical devices and systems. We

are required to follow government-regulated quality assurance
procedures to verify and validate modifications to the operation of our
medical devices.

Operators and owners of this medical equipment must permit only

Philips-authorized changes to be made to these systems, either by Philips’
personnel or under Philips’ explicit published direction.

! Caution
Although the Philips CT operates on a personal computer (PC)
platform, the installation of PC software not specified in the Philips
system documentation may adversely affect the operation and
security of the system, as well as the networks to which the system is
connected. These adverse effects may not be immediately apparent
to the user. Users should therefore not install unauthorized software
onto their system.

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3 -2 Security of System and Data Incisive CT

 Security Issues and Guidelines 3.2

3.2 Security Issues and Guidelines

In addition to the patient information and device integrity needs discussed
in the preceding section on regulatory requirements, the following topics,
issues, and guidelines should be understood and addressed by operators
and owners.

3.2.1 Network Security

The CT must be placed on a secure local computer network that has
protections against viruses and other harmful computer system intruders.
Make sure the equipment is connected to a local network that uses
appropriate protection, such as a firewall and virus scanners. Clinical data
transferred across the network is not encrypted.
• The Host system time can be configured to synchronize with an
Internet time server.

3.2.2 Hard Drive Encryption

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Encryption can be enabled on the Host system hard drive using an

additional license. To enable encryption, contact Philips Service.

Note
Philips

If encryption is enabled on the hard drive, the system performance

might be impacted.
It is recommended to start using the system once disk encryption is
completed.

3.2.3 Remote Service

Philips Healthcare has a global, web-based network for connecting many
of your Philips systems to our advanced service resources. This secure
tunnel approach provides your equipment with a single point of network
access to on-site Philips equipment using Virtual Private Network
technologies. The remote service function is a secure connection through
explicit authorization and authentication control with encryption of all
data.

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Incisive CT Security of System and Data 3- 3

3.3 Access Control

3.3 Access Control

3.3.1 Room Access Control

Local procedures should be put in place to limit physical access to medical
equipment, to prevent accidental, casual, or deliberate contact by
unauthorized individuals.

Access to the room containing the CT should be controlled by policy and

procedures that identify who is authorized to occupy specific areas.
Check with your Safety and Security Office for more information on what
measures are in place or how to implement room access controls.

When the CT is not in use, please click Exit Console in Service

interface to log out, and keep it in a locked room.

3.3.2 Individual Access Control/User Accounts

Individual clinical user accounts are created and managed by the Local
Administrator account.

All authorized clinical users have the same read/write permissions to

perform scans, reviews, analysis, and other standard tasks.

3.3.3 User Account Roles

The following user account roles are supported by the system:
• Clinical
• Local Administrator
• O-level Service
• Philips Service

The ability to install or update the software/firmware is available only to

Philips authorized service personnel.

3.3.4 User Logging

The system logs the user login/logout and system operation, the Service
Engineer can find the file in Logs folder.

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3 -4 Security of System and Data Incisive CT

 Access Control 3.3

3.3.5 User Account Backup and Restore

User account information can be backed up and restored by Philips
Service Representative.

3.3.6 Automatic Screen Blanking

The system is capable of automatically blanking the console displays after
a set period of time in which no mouse or keyboard input occurs.

See “22.6.15 Security Setting” in Instructions for Use for more

information.

3.3.7 Manual Blanking Display

When you leave the console monitor, please manually blank the display.

1 Click Screen Lock at the bottom of the interface.

2 Click Yes to lock the screen.
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3 Click Unlock to activate the screen.

3.3.8 Positioning of Display Monitors

Unauthorized visual access to protected information can be minimized by
Philips

positioning the system’s display monitor so it faces a wall, to prevent

viewing from doorways, hallways and other traffic areas.

To help in limiting unauthorized visual access, an unattended CT display

automatically goes blank after a set period of time.

3.3.9 Manage User Accounts

The clinical user, O-level service user, and default administrator user
account login password will require change upon first login, and the new
login information should be stored in a secure location.

3.3.10 User Login and Logout Protections

A consistent user login process (user names and passwords) provides
good security of protected information. Minimum login standards include:

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Incisive CT Security of System and Data 3- 5

3.3 Access Control

• Implementing strong passwords. This is the easiest and most effective

method to increase security. Strong passwords consist of at least eight
alphanumeric, mixed case characters, digits and special characters like
‘@’ or ‘*’. Never use words that can be found in the dictionary
• Never post or share user names and passwords
• Change passwords periodically

See “22.6.13 User management” in Instructions for Use for more

information.

Emergency Login

To enable Emergency Login, click Service from the Workflow bar, click
System Setting, then click Security Setting and select Enable
Emergency Account.

To log in to the system:

1 Select Emergency login

2 In order to use the emergency login option, a temporary operator
name must be entered in the Operator Name field.
3 Enter the password, if needed.

The operator name and password may consist of letters, numbers, and
underscores.

4 Click Login.

After using the emergency login, the console will display Warning:
Emergency Mode at the bottom of the console screen while the
system is in use. After 5 exams under the emergency login, the user is
required to login again using the same procedure.

Note
An appropriate number of authorized clinical users should be
maintained in order to avoid the use of the emergency clinical user
login.

3.3.11 System Hard Drive

Clinical images that reside in the system hard drive are encrypted if the
Philips-Service enables encryption on the hard drive based on Hospital
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3 -6 Security of System and Data Incisive CT

 Access Control 3.3

request. Even then, it is recommended to restrict access and establish

local access controls to only authorized users.

The system hard drive is sealed to protect against tampering, only Philips
Service can open it.

3.3.12 Personal Data Storage Location

Personal data is stored in the hard drive, in logical disk D and Y drive.

3.3.13 System Backup Media

The clinical data that is backed up on removable media is not encrypted
and should be stored in a secure location to avoid unauthorized access.

3.3.14 Removable and Portable Media

When using removable media (USB, CD-ROMs, and DVD-ROMs,) be
aware of these security issues:
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• Inserting removable media can introduce a virus to the medical

device. Check removable media for viruses before using them.
• Removing media containing patient data can allow access to the data
by unauthorized individuals.
• If the media is to be discarded it must be destroyed or disabled so
Philips

that the data can no longer be accessed.

• If removable media is used to store patient data, protect the
information from media and technical obsolescence by planning and
performing data migrations to newer storage technologies.
• If the removable media is to be stored for safekeeping, protect the
data from “fading” loss by storing it in a suitable environment and
performing media renewal as recommended by the media
manufacturer.

! Caution
Whenever media is inserted into the CT, be sure that the media has
not been exposed to potential viruses, worms and trojans that infect
desktop PCs.

! Caution
Removable media that contains images and/or other medical
information should be stored in a secure area that is not accessible by
unauthorized individuals.

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Incisive CT Security of System and Data 3- 7

3.3 Access Control

3.3.15 Audit Trail

When any of the following events occur, the system logs the event in an
ePHI (Electronic Protected Health Information) audit log:
• Application Activity
• Audit Log Used
• Begin Transferring DICOM Instances
• DICOM Instances Accessed/ Study deleted
• DICOM Instances Transferred
• Patient-record-event
• PHI-export
• PHI-import
• Query Information
• User Authentication

ePHI audit logs are accessible only to the Local administrator through the
use of a special viewer.

The Local administrator can, however, provide this privilege to another

Local Administrator that he or she has created on a case by case basis.
ePHI audit logs are available up to at least 8 months from the initial date
of the log. Logs older than 8 months may be deleted from the archive.
ePHI audit logs can be backed up and restored.

Note
It is recommended to backup the audit trail logs in a secure location.

See “22.10 Audit Trails” in Instructions for Use for more

information.

3.3.16 Data Integrity Checks

The system supports basic system level data and database integrity
checks.

If you suspect improperly altered or destroyed clinical data, notify your

local IT security office or notify Philips service

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3 -8 Security of System and Data Incisive CT

 System Application Control 3.4

3.4 System Application Control

The system utilizes McAfee Application Control, a whitelist file
verification method. This is an alternate approach to preventing virus and
malware infection. The whitelist allows only trusted software provided by
Philips to run, and blocks untrusted software.

! Caution
Whenever media is inserted into the CT system, be sure that the
media has not been previously exposed to potential viruses, worms
and trojans that infect desktop PCs.

In the event that an unauthorized application is opened, or an infected file

is found, the whitelist will prevent it from execution. The system will
display an error detailing the disallowed file activity and log this
information. If you see this error or notice unfamiliar system behavior or
performance changes, especially after the system has been restarted,
contact a Philips Field Service Engineer to have the system checked.
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3.5 Performing Data Sanitization on Hard Drive

You can clear the hard drive contents by using the Secure Erase BIOS
feature or a third-party application that, ideally, is U.S. Department of
Philips

Defense (DOD) 5220.22-M approved.

To run Secure Erase, enter the F10 Bios Setup menu by powering on the
system and pressing F10 as soon as the HP logo appears.

Note
It is recommended to backup all data before performing data
sanitization.

1 Select the Security menu and scroll down to the Hard Drive
Utilities menu and select it.
2 Select Secure Erase.
3 Select the desired drive.
4 There is a message shown.
5 Select Continue.
6 The estimated time to complete Secure Erase is displayed.

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Incisive CT Security of System and Data 3- 9

3.6 3rd party software

7 Select Continue. The elapsed time will be displayed until “Secure

Erase Complete” is displayed.
8 Select Continue to return to the drive selection menu.
Repeat step 3 to step 7 to Secure Erase additional drives.
9 Select the Main menu, click Save Changes and Exit to exit BIOS
Setup, if done.

Note
The Secure Erase process will take a long time. The amount of time
varies based on the hard drive capacity and write speed.
Data Sanitization can be performed by qualified and authorized IT
personnel or Philips service representative. No clinical persons are
allowed to perform Data Sanitization.

3.6 3rd party software

Incisive CT includes the following 3rd party software.

Name Version

Adobe Reader 9.1

McAfee Corporate Virus Scan Command Line 6.0

COPSSH 5.4

UltraVNC 1.0.8.2

Microsoft® SQL Server® 2014 Service Pack 2 (SP2) 12.0.5000.0

Express

Windows 10 OS NA

OpenCV 2.4.10

ITK 5.0

Azure Kinect 1.4.0

Sensor SDK

TensorFlow 1.11.0(for camera)

1.14.0(for post-processing
algorithm)

IPP IPP8

DCMTK354 3.5.4

CUDA 10.0

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3 -1 0 Security of System and Data Incisive CT

 De-Identified Items 3.7

Name Version

CUDNN 7.6

OpenCV 2.4.10

Azure Kinect 1.4.0

Sensor SDK

libpng 1.6.37

PCL 1.11.0

prima NA

TensorRT 7.0.0.11

zlib 1.2.11

3.7 De-Identified Items

The following items are blanked:
• Accession Number
• Image Comment
• Institution Name
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• Institutional Department Name

• Operators' Name
• Patient Comments
• Patient's Birth Date
• Patient's Sex
Philips

• Performed Procedure Code Sequence

• Protocol Name
• Referenced Request Sequence >Requested Procedure Code
Sequence
• Referring Physician's Name
• Requested Procedure Description
• Station Name

The following items are removed:

• Admitting Diagnoses Code Sequence
• Institution Address
• Patient's Age
• Patient's Size
• Patient's Weight
• Performed Procedure Step Description
• Performed Procedure Step ID
• Performed Procedure Step Start Date

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Incisive CT Security of System and Data 3- 11

3.7 De-Identified Items

• Performed Procedure Step Start Time

• Procedure Code Sequence
• Reason for the Requested Procedure
• Referenced Performed Procedure Step Sequence
• Referenced Request Sequence>Reason for Requested Procedure
Code Sequence
• Referenced Study Sequence
• Request Attributes Sequence
• Requested Procedure ID
• Scheduled Procedure Step Description
• Series Description
• Study Description

The following items are modified to “dummystring”:

• Contrast/Bolus Agent
• Device Serial Number
• Study ID

The following item is modified to time string (yyyymmddhhmmssSSS, such

as 20201126093325340):
• PatientID

The following items are modified to new UID:

• Irradiation Event UID
• Referenced Image Sequence>Referenced SOP Instance UID
• SOP Instance UID
• Frame of Reference UID

The following item is modified to Anonymous:

• Patient’s Name

The following items are modified to 19000101:

• Series Date
• Acquisition Date
• Content Date
• Instance Creation Date
• Study Date

The following items are modified to 000000:

• Acquisition Time
• Content Time
• Instance Creation Time

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3 -1 2 Security of System and Data Incisive CT

 Software Distribution 3.8

• Series Time
• Study Time

The following item is modified to 19000101000000:

• Acquisition DateTime

The following items are newly generated:

• PatientIdentifyRemoved: Yes
• De-identification Method Code Sequence: Basic Application
Confidentiality Profile, Clean Descriptors Option, Retain Safe Private
Option

3.8 Software Distribution

Software Distribution option allows you to download and install software
patches released by Philips. The software patches can be automatically or
manually downloaded which are depending on the patches types, when
the system is connected to Philips Remote Service (PRS).The download
happens only when the scanner is not in use. For the hospitals not
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connected to PRS, the software patches can be downloaded from Philips

site and copied on the scanner using removable media by Philips Service,
Third Party Service users.

When the New Software Available icon appears, it means there

Philips

is a package waiting for downloading or already downloaded.

Log off the console software, then log in Software Distribution, when
the patch needs to be downloaded manually, select the desired patch and
click Accept.

After the patch is download, click Install to Install the selected patch.

Note
• The automatic download of software patches may affect the system
performance.
• Once the download is complete, the clinical users will receive a
patch availability notification after login. Philips Service Personnel,
Third Party Service or Local Administrator can install the
downloaded software patches.
• Any failed software patch installation prevents clinical user login
with a notification on the screen.

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Incisive CT Security of System and Data 3- 13

 4 Image performance quality assurance

4.1 Overview
Imaging performance of the scanner is checked by scanning head and body
system phantoms.

When testing image quality, the system should be properly calibrated.

This chapter covers information on these areas:

• Head and body phantom.
• Quality assurance checks-daily and monthly.

Read this section carefully and follow all instructions regarding scheduling
and performance of quality assurance checks.

Note
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• These instructions represent the manufacturer’s required QA

performance checks. If additional testing is required by your
national or local authorities, please contact your service
representative.
• Imaging performance of the scanner must use the same version of
Philips

Incisive CT phantoms which correspond to the system version.

• Observe table position range when executing QA checks, incorrect
table position can cause Non-Diagnostic Image.

! Warning
• Follow Image performance quality assurance instructions to avoid
Image quality degradation.
• Do not perform the IQ check when there is a person in the scanning
room, to avoid people receive unwanted ionizing radiation.

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Incisive CT Image performance quality assurance 4-1

4.2 Head & body system performance phantom

4.2 Head & body system performance phantom

The phantom consists of two portions which cover the aspects of head
and body scans. The out shell of phantom is made of PMMA. This section
covers the specifications of both the head and body portions of the
phantom. Familiarize yourself with this information before you scan either
portion.

There are two kinds of system phantom:

• Acrylic material+PE material
• LEXAN material+PE material

Please refer to the description and tech data for the phantom type
shipped with your system.

The illustration below shows the entire phantom.

Item Description

1 Metal Wire for Slice Thickness Test

2 Metal Wire for Impulse Response

Measurement

3 Air

4 Physics Layer

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4 -2 Image performance quality assurance Incisive CT

 Head & body system performance phantom 4.2

5 PE

6 Water

7 LEXAN/Acrylic

8 Head Water Layer

9 Body Water Layer

10 Water

4.2.1 Head phantom

The head phantom is a PMMA shell filled with water. It is 200 mm in
diameter and consists of two layers:
• Physics layer for impulse response and tomographic section thickness
(slice width) measurements.
• Head Water Layer for measuring noise, CT numbers and Uniformity.
The cylinder made of PE material and the cylinder made of
LEXAN/Acrylic material in head water layer is used for measuring CT
numbers linearity.
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4.2.2 Body phantom

The body phantom is a PMMA shell filled with water. It is 300 mm in
diameter. Only one layer is used for measuring noise, CT numbers and
Uniformity.
Philips

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Incisive CT Image performance quality assurance 4- 3

4.2 Head & body system performance phantom

4.2.3 Phantom composition

Item Description

1 Physics Layer

2 Metal Wire for Slice Thickness Test

3 Metal Wire for Impulse Response Measurement

4 Head Water Layer

5 LEXAN/Acrylic

6 PE

7 Body Water Layer

8 Water

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4 -4 Image performance quality assurance Incisive CT

 Representative quality assurance images 4.3

4.3 Representative quality assurance images

Physics layer using Head STD-QA Water layer using Head STD-QA
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Philips

Body layer using Head STD-QA

Impulse Response FOV= 50 Slice sensitivity profile test using head

scanning protocol

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Incisive CT Image performance quality assurance 4- 5

4.4 Schedule of quality assurance checks

4.4 Schedule of quality assurance checks

Daily checks

Daily checks should be done to ensure the best possible image quality
from your scanner. The procedures for daily checks cover these areas:
• Noise-water layer of the head phantom and the body phantom.
• Uniformity-water layer of the head phantom and the body phantom.
• Low contrast resolution-the body phantom.
• MeanCT-water layer of the head phantom and the body phantom.

Monthly checks

Use your facility’s recommended schedule for monthly checks. You

should check at least once a month.
• Spatial resolution-the physical layer of the head phantom.
• Slice thickness-the physical layer of the head phantom.

Note
You can save QA data and recall at a later date for marking and
measuring. You can save marked images on the system CD or
removable disk.

! Warning
Daily and monthly checks should be done to ensure the best possible
image quality and avoid patient receiving unwanted ionizing radiation.

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4 -6 Image performance quality assurance Incisive CT

 Schedule of quality assurance checks 4.4

4.4.1 Daily checks

Automatic daily image quality checks

Use the water layer of the head and body phantom for these automatic
checks:

1 Install the phantom holder.

Standard Table
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Philips

Bariatric Table

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Incisive CT Image performance quality assurance 4- 7

4.4 Schedule of quality assurance checks

2 Position the System Phantom on the phantom holder.

Standard Table

Bariatric Table

3 Open laser light.

4 Manually control the height of the System Phantom Bracket, center
the laser beam on the center of the phantom.

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4 -8 Image performance quality assurance Incisive CT

 Schedule of quality assurance checks 4.4

5 Manually move the Patient Support Top so that the Laser Marker set
to center of phantom.

Water Layer

6 Select QA from the Service. Follow the on-screen prompts for

viewing and reporting the results.

Manual daily image quality checks (optional)

Use the water layer of the head and body phantom for these manual
checks.
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Head scan

1 Position the water layer of the head phantom in the center of the scan
circle.
Philips

2 Perform a scan using the Head STD-QA 2D protocol with scan and
reconstruction parameter values in the following tables:

Scan parameters

Scan Type Axial

Voltage (kV) 120 kV

Current (mA) 380 mA

Rot Time (s) 1.0 s

Collimation (mm) 32 x 0.625

Resolution Standard

Reconstruction parameters

Slice thickness (mm) 5

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Incisive CT Image performance quality assurance 4- 9

4.4 Schedule of quality assurance checks

Reconstruction parameters

FOV (mm) 250

Matrix 512

Filter UB

iDose4 3

3 Check the resulting images to ensure they are free of artifacts.

Note
• If the images display with artifacts, check that the water phantom is
the only item contained within the scan field, and repeat the
procedure.
• If the problem continues, contact your service specialist.

4 Select one from these images.

5 Place around the center of the phantom image a ROI with an area of
3000 ± 1000 mm2.
6 Check these items:

AV (Average Value) 0 ± 4.0 HU

SD (Standard Deviation) 2.05 ± 0.75

Body scans

1 Position the body phantom in the center of the scan circle.

2 Perform a scan using the Body STD-QA Helical protocol (under
Abdomen) with scan and reconstruction parameter values in the
following tables:

Scan parameters

Scan Type Helical

Voltage (kV) 120 kV

Current (mA) 293 mA

Pitch 1.0

Rot Time (s) 0.75 s

Collimation (mm) 32 x 0.625

Resolution Standard

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4 -1 0 Image performance quality assurance Incisive CT

 Schedule of quality assurance checks 4.4

Reconstruction parameters

Slice thickness (mm) 3

FOV (mm) 350

Matrix 512

Filter B

iDose4 3

3 Check the resulting images to ensure they are free of artifacts.

Note
• If the images display with artifacts, check that the body phantom is
the only item contained within the scan field, and repeat the
procedure.
• If there is still a problem, contact your service specialist.

4 From these images, select one to conduct the remainder of the

checks.
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5 Check the CT number of the body water layer. It should be as

follows:

AV (average) 0 ± 4 HU

SD (Standard Deviation) 11.5 ± 1.70

Philips

! Warning
Screw down the phantom holder screws. The water phantom must be
stably fixed on the phantom holder. If phantom holder or water
phantom is not engaged securely, it can come loose causing injury to
the patient.

4.4.2 Monthly checks

Use the multi-pin layer of your phantom for monthly checks.

Note
• If the images display with artifacts, check that the phantom is the
only item contained within the scan field, and repeat the procedure.
• If there is still a problem, contact your service specialist.

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Incisive CT Image performance quality assurance 4- 11

4.4 Schedule of quality assurance checks

Automatic constancy check

During this procedure, you will move the phantom up, down and to the
right or left in accordance with the on-screen prompts.

1 Position the system phantom.

2 Select Constancy from the Service menu.
3 Click Next to begin.
4 When the test is complete, click Report to view the results.

Head scan
1 Position the water layer of the head phantom in the center of the scan
circle.
2 Perform a scan using the Head protocol with these scan and
reconstruction parameter values:

Scan parameters

Scan Type Axial

Voltage (kV) 120 kV

Current (mA) 300 mA

Rot Time (s) 1.0 s

Collimation (mm) 32 x 0.625

Resolution Standard

Reconstruction parameters

Slice Thickness (mm) 10

FOV (mm) 250

Matrix 512

Filter UB

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4 -1 2 Image performance quality assurance Incisive CT

 Schedule of quality assurance checks 4.4

Absorption readings

The readings for the absorption of the different pins must be as follows
(values in CT numbers):

Water 0 ± 4 HU

PE -60 ± 40 HU

LEXAN 120 ± 40 HU

Acrylic 120 ± 40 HU

! Warning
All measurements should be made by positioning a small ROI well
within each of the checked pins and regions. Because the phantom is
comprised of a variety of materials, you may need to refer to the
phantom label for specific values.

Image performance parameters

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Reference IEC 60601-2-44 Clause 203.6.7.2.

Min. Max.

CT Adult Head 120 kV 380 mA 32*0.625 Normal UB FOV 250 -4 HU 4 HU

Philips

Number
Body 120 kV 300 mA 32*0.625 Normal B FOV 350 -4 HU 4 HU

70 kV 600 mA 32*0.625 Normal B FOV 350 -6 HU 6 HU

80 kV 500 mA 32*0.625 Normal B FOV 350 -6 HU 6 HU

100 kV 400 mA 32*0.625 Normal B FOV 350 -6 HU 6 HU

140 kV 300 mA 32*0.625 Normal B FOV 350 -6 HU 6 HU

Pediatric Head 100 kV 433 mA 32*0.625 Normal UB FOV 250 -4 HU 4 HU

Body 120 kV 300 mA 32*0.625 Normal B FOV 250 -4 HU 4 HU

70 kV 600 mA 32*0.625 Normal B FOV 250 -6 HU 6 HU

80 kV 500 mA 32*0.625 Normal B FOV 250 -6 HU 6 HU

100 kV 400 mA 32*0.625 Normal B FOV 250 -6 HU 6 HU

140 kV 300 mA 32*0.625 Normal B FOV 250 -6 HU 6 HU

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Incisive CT Image performance quality assurance 4- 13

4.4 Schedule of quality assurance checks

Uniformity Adult Head 120 kV 380 mA 32*0.625 Normal UB FOV 250 -4 HU 4 HU

Body 120 kV 300 mA 32*0.625 Normal B FOV 350 -8 HU 8 HU

70 kV 600 mA 32*0.625 Normal B FOV 350 -8 HU 8 HU

80 kV 500 mA 32*0.625 Normal B FOV 350 -8 HU 8 HU

100 kV 400 mA 32*0.625 Normal B FOV 350 -8 HU 8 HU

140 kV 300 mA 32*0.625 Normal B FOV 350 -8 HU 8 HU

Pediatric Head 100 kV 433 mA 32*0.625 Normal UB FOV 250 -4 HU 4 HU

Body 120 kV 300 mA 32*0.625 Normal B FOV 250 -4 HU 4 HU

70 kV 600 mA 32*0.625 Normal B FOV 250 -8 HU 8 HU

80 kV 500 mA 32*0.625 Normal B FOV 250 -8 HU 8 HU

100 kV 400 mA 32*0.625 Normal B FOV 250 -8 HU 8 HU

140 kV 300 mA 32*0.625 Normal B FOV 250 -8 HU 8 HU

Noise Adult Head 120 kV 380 mA 32*0.625 Normal UB FOV 250 1.3 2.8

Body 120 kV 300 mA 32*0.625 Normal B FOV 350 6.7 9

70 kV 600 mA 32*0.625 Normal B FOV 350 11.2 15.0

80 kV 500 mA 32*0.625 Normal B FOV 350 8.5 11.3

100 kV 400 mA 32*0.625 Normal B FOV 350 5.9 7.9

140 kV 300 mA 32*0.625 Normal B FOV 350 4.05 5.55

Pediatric Head 100 kV 433 mA 32*0.625 Normal UB FOV 250 3.3 4.8

Body 120 kV 300 mA 32*0.625 Normal B FOV 250 2.85 4.35

70 kV 600 mA 32*0.625 Normal B FOV 250 4.9 6.5

80 kV 500 mA 32*0.625 Normal B FOV 250 3.75 5.25

100 kV 400 mA 32*0.625 Normal B FOV 250 2.65 4.15

140 kV 300 mA 32*0.625 Normal B FOV 250 1.75 3.25

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4 -1 4 Image performance quality assurance Incisive CT

 Schedule of quality assurance checks 4.4

MTF Adult Head 10% 120 kV 380 mA 32*0.625 Normal UB FOV 50 4.67 lp/cm 6.32 lp/cm
MTF

50% 120 kV 380 mA 32*0.625 Normal UB FOV 50 2.72 lp/cm 3.68 lp/cm
MTF

Body 10% 120 kV 100 mA 4*0.625 High YC FOV 50 8.1 lp/cm 10.9 lp/cm
MTF

50% 120 kV 100 mA 4*0.625 High YC FOV 50 4.8 lp/cm 6.4 lp/cm
MTF

Pediatric Head 10% 100 kV 433 mA 32*0.625 Normal UB FOV 50 4.67 lp/cm 6.32 lp/cm
MTF

50% 100 kV 433 mA 32*0.625 Normal UB FOV 50 2.63 lp/cm 3.56 lp/cm
MTF

Body 10% 120 kV 150 mA 4*0.625 High YC FOV 50 8.1 lp/cm 10.9 lp/cm
MTF

50% 120 kV 150 mA 4*0.625 High YC FOV 50 4.8 lp/cm 6.4 lp/cm
MTF

4.4.3 Advanced quality assurance checks

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These procedures can be useful for resolving problems revealed by the

daily checks. They are intended for use as advanced applications for
Physicists and your service specialist.
Philips

Impulse response measurements

1 Position the physics layer of the head phantom in the center of the
scan circle, taking care to make sure the 0.2 mm copper wire (in the
center of the layer) is perpendicular to the scan direction.
2 Perform a scan using the Head Std (SB) protocol, with the parameter
values listed in the Daily Checks section.
3 Click Service.
4 Select Advanced.
5 Click Image Evaluation. The system displays a window.
6 Select an image.
7 Select Spatial Resolution
8 Scroll through the images to access the copper wire.
9 Click Show to display the MTF.

Reference IEC 60601-2-44 Clause 203.6.7.2.

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Incisive CT Image performance quality assurance 4- 15

4.4 Schedule of quality assurance checks

MTF graphs evaluation

Tomographic section thickness (slice width)

measurements

Reference IEC 60601-2-44 Clause 203.6.7.2.

This function is used to check the Slice Thickness (width) of the scanner
during monthly tests. Available protocols depend on your scanner type.

1 Install the system phantom used for slice width measurements.

2 Perform a lateral scan.
3 Plan an axial slice on the image as shown in the example below. The
dotted line indicates the planned scan:

If it is necessary, adjust phantom holder angle to ensure axis of the

phantom is perpendicular to the rotating plane.

4 Adjust In/Out position of phantom to obtain better precision.

5 Perform a scan using the Brain STD-QA protocol, with the parameter
values listed in the Daily Checks section.
6 Click Service.
7 Select Advanced.

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4 -1 6 Image performance quality assurance Incisive CT

 Schedule of quality assurance checks 4.4

8 Click Image Evaluation. The system displays a window.

9 Select an image.
10 Select Slice Thickness.
11 Draw ROI in the area of copper wire.
12 Click Evaluate to measure the thickness
13 Repeat the procedure for these slice thicknesses and tolerances:

Slice thickness FWHM value

0.625 mm 0.625 mm ± 0.5 mm

0.67 mm 0.67 mm ± 0.5 mm

0.8 mm 0.8 mm ± 0.5 mm

0.9 mm 0.9 mm ± 0.5 mm

1.0 mm 1.0 mm ± 0.5 mm

1.25 mm 1.25 mm ± 0.625 mm

1.5 mm 1.5 mm ± 0.75 mm

2.0 mm 2.0 mm ± 1.0 mm

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2.5 mm 2.5 mm ± 1.0 mm

3 mm 3 mm ± 1.0 mm

3.5 mm 3.5 mm ± 1.0 mm

4 mm 4 mm ± 1.0 mm
Philips

4.5 mm 4.5 mm ± 1.0 mm

5.0 mm 5.0 mm ± 1.0 mm

10.0 mm 10.0 mm ± 1.0 mm

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Incisive CT Image performance quality assurance 4- 17

 5 User information

5.1 Overview
The following chapter contains information about preventative
maintenance, physics details, dose analysis, and system specifications.

Be sure to familiarize yourself with this information before conducting any

scan procedures.

5.2 Technique factors-maximum deviations

5.2.1 Peak x-ray tube voltage

Reference IEC 60601-2-44 Clause 201.12.1.101.

The peak X-ray voltage displays on the console. The actual X-ray voltage
459801855482_A

during scan is within ±10% of the displayed value, which is in the range of
70 to 140 kV.

The peak X-ray voltage is measured on a equipment, which is calibrated

during the manufacturing process.
Philips

5.2.2 Tube current

Reference IEC 60601-2-44 Clause 201.12.1.101.

The tube current displays on the console. The actual tube current during
scan is within ±20% of the displayed value, which is in the range of 5 to
667mA.

The peak X-ray voltage is measured on a equipment, which is calibrated

during the manufacturing process.

5.2.3 Scan Time

The scan time displays on the console. The actual scan time during scan is
within ±10% of the displayed value.

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Incisive CT User information 5-1

5.3 Gantry laser localizer

The peak X-ray voltage is measured on a equipment, which is calibrated

during the manufacturing process.

5.2.4 Tube current-exposure time product

The actual current-exposure time product (in mAs) during a scan is
within -28% to 32% of the value displayed on the console. The tube
current-exposure time product is measured on a equipment, which is
calibrated during the manufacturing process.

5.3 Gantry laser localizer

The Incisive CT gantry system contains two internal laser localizers,
located on the top left and right side of the gantry, perpendicular to Z
direction. The Laser light button turns the lasers on and off.

When the lasers are on, the slice plane is marked by a long, thin light-
beam. The laser light field indicates the central slice of the entire scan
range. The center of the gantry opening is marked by shorter and thicker
perpendicular beams on the top and sides of the body.

Note
Reference IEC 60601-2-44 Clause 203.115.
• The precision of the internal laser localizer is ± 2mm.
• The accuracy of the location of the isocentre with respect to the
laser markers marking the sagittal positioning is ±14.5mm and
marking the coronal positioning is ±12mm.

! Warning
• Laser radiation.
• Do not stare into laser beam when you use of optical instruments,
such as eyeglasses with large diopter or mirrors.
• 1M laser production.

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5 -2 User information Incisive CT

 Preventive maintenance 5.4

5.4 Preventive maintenance

Reference IEC 60601-1 Clause 7.9.2.13.

Routine preventive maintenance for the whole CT system is scheduled

every six months and should be performed by qualified Philips personnel.
As part of routine maintenance, the Service Engineer will use a diagnostic
program to check these items:
• Anode voltage
• Cathode voltage
• Emission current
• Exposure time

5.4.1 Cleaning and Disinfection of the System

Reference IEC 60601-1 Clause 7.9.2.12.

Cleaning and disinfection are critical to minimize the risks of transmission

of infectious agents.
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Cleaning is the removal of contaminants. It consists of the removal,

usually with detergent and water, of adherent soil (e.g. blood, protein
substances, and other debris) from the surfaces, crevices, serrations,
joints, and lumens of a medical device. Disinfection is the process to
Philips

reduce the number of viable microorganisms. This product is classified as

non-critical device that is intended to contact with intact skin, therefore
low to intermediate level disinfection is required. Cleaning and
disinfection should follow recommendations for low to intermediate level
disinfection as defined by the government agencies, e.g. CDC, using the
products approved and registered with your governing authorities, e.g.
EPA and VAH.

! Caution
• Wear proper Personal Protective Equipment (PPE), e.g. gloves and
glasses, for cleaning and disinfection.
• Follow the cleaning/disinfection product manufacturer’s instructions
for cleaning and disinfection.

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Incisive CT User information 5- 3

5.4 Preventive maintenance

! Warning
Use of inappropriate cleaning materials can cause skin irritation,
allergic reaction and poisoning.

The following can be used for cleaning the system including the console,
gantry, table, and accessories:
• Distilled water
• Methylated spirit
• Bleach and water solution or disinfectant wipes at ratios of up to 1:10

The following disinfectants can be used for disinfecting the system

including the console, gantry, table, and accessories. Only the products
approved and registered with the governing authorities, e.g. EPA and
VAH, should be used.
• 1:10 bleach equivalent spray cleaner or wipes
• Low- or intermediate-level disinfectant Germicidal Wipes or liquid
• 3% Hydrogen Peroxide
• Ethanol
• Quaternary ammonium compounds
• Benzyl-C12-18-alkyldimethyl

Based on how the parts are exposed to the patients, the extent of the
exposures and the frequency of the exposures, the following
cleaning/disinfection frequencies are recommended:
• Parts that the patients make direct contact with during normal scans
shall be cleaned/disinfected for every patient;
• Parts the patients could touch or the patient body fluid (blood or
other potentially infectious materials) could reach shall be
cleaned/disinfected daily.
• Noncritical environmental parts that the patients do not touch or the
patient fluid (blood or other potentially infectious materials) is not
expected to reach, shall be cleaned/disinfected weekly or as needed

! Caution
• After each occurrence of spill of contrast medium or patient body
fluid (blood or other potentially infectious materials), immediately
remove any residual contrast medium and/or patient body fluid,
followed by cleaning and disinfection. Contact service engineers if
the contrast medium or patient body fluid get inside the equipment.

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5 -4 User information Incisive CT

 Preventive maintenance 5.4

• Blood and contrast medium are health risks. Take appropriate

health and safety precautions when removing blood or residual
contrast medium.

Tips:
• After cleaning and disinfection, inspect for any damages to the parts,
e.g. cracks on the covers, degraded labels, or torn/broken parts etc.
Contact Philips Service Representative immediately if any parts are
damaged, to avoid risk of electric shock.
• Clean and disinfect the system after installation and before first clinical
use.
• When cleaning the front and rear covers on the scanners, cover the
microphones to avoid leaking the cleaning solution inside.
• When cleaning the buttons, mouse and the inside of the Gantry
opening, take care to avoid leaking the cleaning solution inside.
• When cleaning the monitor screens, use soft cloth, if necessary,
moistened with water or LCD cleaner. Do not use any corrosive
agents or abrasive agents. Damp cloth can be used but never use wet
cloth.
• Activate the clean screen function when cleaning the touch panels (if
equipped). Use soft cloth, if necessary, moistened with water or LCD
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cleaner. Do not use any corrosive agents or abrasive agents. Damp

cloth can be used but never use wet cloth.
• The patient restraints can be machine washed or dry-cleaned. Wash
the restraints closed to protect the Velcro parts. Remove
contaminations with wet cloth. On site cleaning can be performed
using specified cleaners/disinfectants, followed by cleaning with water
Philips

as needed. Make sure the patient restraints are completely dry before
using or storing them.
• Apply solution on lint-free wipes if solutions are used. Do not apply
solutions directly on the device.
• Rinsing, when needed, should be done with a damp lint-free wipes.
Wipes can be damped with distilled water.
• Drying, when needed, should be done with lint-free wipe.

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Incisive CT User information 5- 5

5.5 X-Ray system specifications

5.5 X-Ray system specifications

5.5.1 X-ray tube

Reference IEC 60601-2-44 Clause 201.7.2.15.
• Leakage radiation factor: 140kV and 43 mA.
• Filtration: Minimum tube housing filtration is 1.1mm aluminum using
a 1.1 mm filter plate at 75 kV.
• Maximum Heat Dissipation: 6.6 kW.

Continuous anode input power

Reference IEC 60601-2-44 Clause 203.12.3.

Continuous anode input power: 5.5 kW

kV mA

70 5 through 667

80 5 through 667

100 5 through 667

120 5 through 667

140 5 through 571

Cooling curve and Power rating

The heating and cooling curves include the heat capacity of the cooling unit.
They show the maximum heat content of the X-ray tube assembly.

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5 -6 User information Incisive CT

 X-Ray system specifications 5.5

The anode heating and cooling curves show the maximum heat content of the
X-ray tube.

Power rating chart

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Philips

Large focus rating chart

Small focus rating chart

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Incisive CT User information 5- 7

5.5 X-Ray system specifications

5.5.2 Focal spot and dimensional data

Zone of extra-focal radiation (X-Y plane, mm)

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5 -8 User information Incisive CT

 X-Ray system specifications 5.5

Zone of extra-focal radiation (Z-Y plane, mm)

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Philips

General dimensional data (mm)

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Incisive CT User information 5- 9

5.5 X-Ray system specifications

5.5.3 X-ray power supply

• Line Voltage and Regulation: Power supply input voltage is 3
Phase, 380/400 VAC ±10%, nominal line-to-line, 50/60 Hz.
• Line Current: Maximum line current is 200 A/phase at 400 V input
voltage, output the maximum voltage 140 kV(571 mA), maximum
current 667 mA (120 kV).
• Measurement Criteria: Peak x-ray tube voltage is calculated by
averaging samples that are 90% of the peak value. Time starts the first
time the dose rate waveform reaches 50% of peak, and ends the last
time it drops below 50%. Intermediate readings are time since start
trig; mA Measurement: Measure the effective values after the
radiation is on for over 1s (stabilization time >=20ms)

5.5.4 Generator rating and duty cycle

• Generator: Octavia
• Duty cycle: 4s scan time, 0.67% duty cycle @80kW and 60s scan time,
10% duty cycle @40kW
• Maximum input line voltage: 3 Phase, 380/400 VAC ± 10%, 50/60 Hz
• Maximum output voltage: 140 kV
• Maximum output current: 667 mA
• Maximum output power: 80 kW

5.5.5 Leakage radiation

The leakage radiation of the tube housing assembly together with the
beam limiting device is less than 0.88mGy/h from a distance of 1 meter to
the focal spot at 140kV and 43 mA.

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5 -1 0 User information Incisive CT

 CT mean and standard deviation 5.6

5.6 CT mean and standard deviation

You can view information for an ROI using the ROI tools in the common
tools box. The system displays the CT number which is calculated from
the average CT value of all the pixels in the ROI. Standard deviation (SD)
is calculated from the CT value of all the pixels in the ROI.
x – w
Contrast scale = --------------------------------
-
 CT  x –  CT  w

Where:

µ = Linear attenuation coefficient of water

w

µ = Linear attenuation coefficient of material of interest

x

(CT)w = CT number of water

(CT)x = CT number of material of interest

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Note
Percent noise: The SD as displayed on the screen is divided by [AV +
1000] and multiplied by 100 to obtain the percent noise.
Philips

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Incisive CT User information 5- 11

5.7 Dose and imaging information

5.7 Dose and imaging information

5.7.1 Filtration information

Reference IEC 60601-2-44 Clause 203.7.3.

Tube inherent filtration 1.1 mm Al 75kV

Slab filter outside the tube 1.0 mm Ti, equivalent to 3.63 mm Al 75 kV

Wedge filter outside the tube The thinnest in the mid is 2.11 mm Al

Minimum permanently filtration 6.84 mm Al 75 kV

Collimation total filtration 5.74 mm Al 75 kV

5.7.2 Half value layer

Reference IEC 60601-2-44 Clause 203.7.1.

Half value relative to voltage

16 x 0.625 mm

70 kV Hvl 5.46 mm AI

80 kV Hvl 6.20 mm AI

100 kV Hvl 7.40 mm AI

120 kV Hvl 8.33 mm AI

140 kV Hvl 9.11 mm AI

5.7.3 Dosimetry Phantoms and measurement methods

Reference IEC 60601-2-44 Clause 203.5.2.4.2 and 203.108.
• The phantom is PMMA.
• The diameter of head phantom is 16 cm. Head phantom is placed on
the head holder.
• The diameter of body phantom is 32 cm. Body phantom is placed on
patient table.
• The distance between the hole center of B1,B2,B3, and B4, to the
outer surface is 10 mm.
• The length of the dosimetry phantom is 145 mm.

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5 -1 2 User information Incisive CT

 Dose and imaging information 5.7

5.7.4 CTDI and dose analysis information

Reference IEC 60601-2-44 Clause 203.109, and 201.3.212.

The table below displays typical CT conditions of operation for dosage

testing.
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Voltage 120 kV

Slice Thickness 32 x 0.625 mm

Scan Time 1s

mA 300 mA
Philips

50 mm
D  z
CTDI100 =  ------------ dz
– 50 mm N T

CTDIW = 1--- CTDI100 (center) + 2--- CTDI100 (peripheral)

3 3

For axial scanning:

with these definitions:

• N = the number of tomographic sections produced in a single axial
scan of the X-ray source
• T = the nominal tomographic thickness
• Δd = the patient support travel in z-direction between consecutive
scans.

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Incisive CT User information 5- 13

5.7 Dose and imaging information

Reference IEC 60601-1-3 Clause 6.4.5.

Maximum deviation from the values shown below is ± 20% or 1mGy. (

take the larger one as standard).

CTDIw of CTDI Head= 45.9 mGy.

CTDIw of CTDI Body= 25.54 mGy.

The maximum deviation from the reported CTDIw for 2 x 0.625 is ±

20%.

CTDI Head CTDI Body

The maximum dose is delivered at the 12 o’clock position on each figure

above. The following tables show dosage value (CTDI) of the phantom in
different positions (120 kV, 300 mA, 1s, 32 x 0.625 mm) under typical
parameter conditions. All measurements are in mGy.

CTDI100 B1 B2 B3 B4 B5 CTDI CTDIw

peripheral

Head 50.32 45.70 45.41 48.66 42.67 47.52 45.91

Body 37.06 31.01 28.51 28.33 14.45 32.33 26.38

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5 -1 4 User information Incisive CT

 Dose and imaging information 5.7

Reference IEC 60601-2-44 Clause 203.109.1.

The typical condition is 120 kV, 300 mA, 1 s, 32x0.625 mm, the figures
below show radiation relationship among different kV, collimation, mA,
and rotation time. Only one parameter can be modified each time. The
configuration of other parameters is typical value, all the results are
normalized by typical condition. The figures below are the normalized
central and peripheral CTDI plots for body and head.

Note
The normalized central and peripheral CTDI plots are same, except
kV plot.
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Philips

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Incisive CT User information 5- 15

5.7 Dose and imaging information

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5 -1 6 User information Incisive CT

 Dose and imaging information 5.7

The table shows normalized maximum CTDI for head and body.

CTDI100

Maximum CTDI100 at 70kV 0.18

Maximum CTDI100 at 120kV 1.00

Maximum CTDI100 at 140kV 1.47

Reference IEC 60601-2-44 Clause 203.109.2.

Voltage (kV) Thickness (mm) CTDIFREEAIR

(50 mA, 1s)

Head 120 kV 64 x 0.625 8.53

120 kV 32 x 0.625 9.42

Body 70 kV 64 x 0.625 1.76

80 kV 64 x 0.625 2.75

100 kV 64 x 0.625 5.29

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120 kV 2 x 0.625 26.86

120 kV 4 x 0.625 19.40

120 kV 12 x 0.625 11.85

120 kV 16 x 0.625 10.71

Philips

120 kV 16 x 1.25 9.42

120 kV 32 x 0.625 9.42

120 kV 64 x 0.625 8.53

120 kV 12 x 1.25 10.04

120 kV 32 x 1.25 8.53

140 kV 64 x 0.625 12.53

Voltage (kV) Thickness (mm) CTDIFREEAIR

(300mA, 1s)

Head 120 kV 64 x 0.625 51.11

120 kV 32 x 0.625 56.32

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Incisive CT User information 5- 17

5.7 Dose and imaging information

Voltage (kV) Thickness (mm) CTDIFREEAIR

(300mA, 1s)

Body 70 kV 64 x 0.625 10.59

80 kV 64 x 0.625 16.47

100 kV 64 x 0.625 31.76

120 kV 2 x 0.625 161.38

120 kV 4 x 0.625 116.51

120 kV 12 x 0.625 71.32

120 kV 16 x 0.625 64.12

120 kV 16 x 1.25 56.32

120 kV 32 x 0.625 56.32

120 kV 64 x 0.625 51.05

120 kV 12 x 1.25 60.10

120 kV 32 x 1.25 51.05

140 kV 64 x 0.625 74.20

For CTDIFREEAIR, each value is within ± 10 percent of the mean of a set of

ten measurements.

Maximum CTDI (peripheral) under conditions of 100

operation
Conditions Maximum CTDI100 (peripheral)

Helical\ Brain\ 140 kV\571 mA\ Rotation 675.72 mGy

time=1 s\Collimation=32 x 0.625\ Pitch=0.2

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5 -1 8 User information Incisive CT

 Dose and imaging information 5.7

5.7.5 Dose and sensitivity curves

Dose profile and CTDI SSP 100

2 x 0.625 mm Slice

Head Body
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Philips

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Incisive CT User information 5- 19

5.7 Dose and imaging information

16 x 0.625mm Slice

Head Body

16 x 1.25mm Slice

Head Body

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5 -2 0 User information Incisive CT

 Dose and imaging information 5.7

32 x 0.625mm Slice

Head Body

64 x 0.625 mm Slice

Head Body
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Philips

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Incisive CT User information 5- 21

5.7 Dose and imaging information

Dose profile and CTDI FREEAIR SSP

Reference IEC 60601-2-44 Clause 203.110 and 203.111.

2 x 0.625 mm Slice

16 x 0.625 mm Slice

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5 -2 2 User information Incisive CT

 Dose and imaging information 5.7

16 x 1.25 mm Slice

32 x 0.625 mm Slice
459801855482_A
Philips

64 x 0.625 mm Slice

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Incisive CT User information 5- 23

5.8 Geometric efficiency in the Z direction

5.8 Geometric efficiency in the Z direction

Reference IEC 60601-2-44 Clause 203.113.
Collimation Geometric Efficiency (percent)

2 x 0.625 27.19

4 x 0.625 38.07

12 x 0.625 63.46

16 x 0.625 70.15

16 x 1.25 80.44

32 x 0.625 80.44

64 x 0.625 88.72

12 x 1.25 75.42

32 x 1.25 88.72

5.9 IEC stray radiation dose map

Reference IEC 60601-2-44 Clause 203.13.2.

Only qualified personnel can evaluate shielding in the scan room. These
factors must be considered:
• device position
• scan workload
• materials of walls, floor, ceiling, doors and windows

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5 -2 4 User information Incisive CT

 Size Specific Dose Estimate (SSDE) 5.10

The image below describes the radiation level in the process of scanning a
320 mm (Body Part) polyethylene phantom in the scanning room.
459801855482_A
Philips

• Scan Condition: 140 kV, 571 x 1.5 mAs

• Proportional Scale: 0.5m
• Dosage Unit: nGy/1 mAs

5.10 Size Specific Dose Estimate (SSDE)

Size Specific Dose Estimate (SSDE)

The CTDIvol provided by the scanner is a measure of the absorbed dose,

expressed in units of mGy, to either a 32 cm or 16 cm diameter acrylic

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Incisive CT User information 5- 25

5.10 Size Specific Dose Estimate (SSDE)

phantom over the volume scanned with a specific Exam Card. The
CTDIvol for a selected Exam Card, therefore, does not represent the
absorbed dose to a patient. For infants, the CTDIvol underestimates the
absorbed dose to the scan volume by up to a factor of 3. Conversely, the
CTDIvol for large patients overestimates absorbed dose to the scan
volume; for very large patients CTDIvol can overestimate absorbed dose
by as much as 40%.

Through a series of experiments and models, the American Association

of Physicists in Medicine devised conversion factors from CTDIvol to a
new dose metric, Size Specific Dose Estimate (SSDE) also expressed in
units of mGy. The appropriate SSDE conversion factor for a given patient
depends on the attenuation of the patient and the top of the couch in the
scanned area. The SSDE is the product of this patient attenuation-specific
conversion factor and the CTDIvol for the selected Exam Card. For infant
head and body scans, the conversion factors are typically larger than 1
because infant heads and bodies are smaller than the 16 cm and 32 cm
phantom, respectively, used to calculate CTDIvol for the Exam Card; for
these patients, SSDE values are higher than CTDIvol values. For adult
body scans the conversion factor is typically smaller than 1, since patients
are usually larger than the 32 cm phantom used to calculate CTDIvol; for
these patients, SSDE values are lower than CTDIvol values. For adult
head scans, the conversion factors are usually closer to 1 such that SSDE
and CTDIvol values are similar.

SSDE provides a better estimate of the average absorbed dose to the

patient by taking into account both the radiation output of the CT
scanner and the patient’s size. Although SSDE is intended to describe
dose for patients of all sizes, better estimates of dose are especially
important for small pediatric patients since the actual absorbed dose to
the patient is higher than

indicated by the CTDIvol for a given Exam Card and because radiation
exposure is of greatest concern in infants and children.

The IEC is formalizing the calculation of SSDE into a new standard so that
all vendors can define and provide this new metric in the same way.
When a Surview is performed and DoseRight is enabled, the scanner
calculates a Water Equivalent Diameter (WED) for the patient, that is,

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5 -2 6 User information Incisive CT

 Size Specific Dose Estimate (SSDE) 5.10

the diameter of a water equivalent cylinder with the same X-ray

attenuation as the patient and the couch top, over the entire Surview.
This value is displayed as Patient Size with units of cm on the Surview
image. When a shorter scan range is selected for the clinical scan, the
Patient Size is still displayed but the scanner also calculates an Average
Scan Size in cm, representing the average WED within the scan region
only. Average Scan Size is the patient metric used to determine the
appropriate conversion factor for SSDE calculation.

Before each clinical scan, the scanner displays an estimated Average Scan
Size and SSDE based on the planned scan region and the planned x-ray
output. After a clinical scan, the scanner recalculates Average Scan Size
and SSDE based on the actual scan region and the actual x-ray output
(estimated and actual values are usually the same). Updated values for
Average Scan Size and SSDE are included in the preview display. Final
values for all scans are also tabulated in the dose report, compiled at the
completion of the exam.

The data used to determine the SSDE conversion factor covered

459801855482_A

PATIENT diameters ranging from approximately 8 cm to 40 cm. Because

the data exhibited smooth behaviour, SSDE is calculated and displayed for
PATIENT diameters outside of this range by extrapolation of the SSDE
conversion factors.
Philips

General limitations of the Size Specific Dose

Estimate (SSDE) methodology

It is important to recognize that SSDE is still an estimate of the absorbed

dose to the scan volume even though it takes into account patient
attenuation in the scanned region. The accuracy of this estimate,
compared to the actual absorbed dose to the scan volume, is
approximately ±20%.

Limitations of SSDE in special clinical scenarios

Neck included in scanned anatomy

Additional uncertainty in SSDE of approximately 10% is expected for

scans of the head and neck when the scan length in the head and neck

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Incisive CT User information 5- 27

5.10 Size Specific Dose Estimate (SSDE)

region are approximately equal. This is because conversion factors for the
head are applied to the entire scan length even though they are not as
appropriate for the neck.

Range of scan projection radiograph exceeded

If the actual scan length exceeds the range of the scan projection
radiograph, the manufacturer shall estimate WEB based on attenuation
data acquired within the region of the scan projection radiograph, in the
majority of clinical cases, the additional uncertainty in the SSDE is not
expected to exceed 5 %.

Single or bilateral extremities are scanned

In the case of bilateral lower extremity scans or bilateral upper extremity

scans where the arms are above the head, patient size estimates from the
surview image can be less accurate. This can have a minor impact on the
SSDE but any additional uncertainty in the estimate is not expected to
exceed 5%.

Patient is not positioned at the center of rotation along

the source/detector direction

When patients are not properly centered, patient size estimates from the
surview image can be less accurate. Any additional uncertainty in the
estimate of SSDE is not expected to exceed 5%.

Patient anatomy outside the scan field of view

Patient anatomy outside the scan FOV will result an underestimation of

patient size from the surview and an overestimation of SSDE. However,
at large patient sizes, the conversion factors vary slowly with changes in
patient size. Except for morbidly obese patients, any additional
uncertainty in the estimate of SSDE is not expected to exceed 5%.

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5 -2 8 User information Incisive CT

 Size Specific Dose Estimate (SSDE) 5.10

Foreign Objects in the Scan Field

When foreign objects (e.g., metal implants, radiation therapy planning

hardware, life support devices, bismuth shields) are in the scan FOV,
patient size estimates from the surview image can be less accurate. The
magnitude of uncertainty in estimation of patient size will depend on the
physical size of the foreign object and the attenuation of that material
relative to bone and soft tissue. This may result in overestimation of
patient size and an underestimation of SSDE causing additional
uncertainty in the SSDE that may exceed 5%.

Wed measurement conditions

Generation of DW,REF(z) for the water PHANTOMS

Large water Small water

phantom phantom

CT conditions of KVp 120 120

operation
mAs 200 300
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Pitch 1 0.4

Rotation Speed 0.75 0.5

Collimation 32*0.625 32*0.625

Resolution Standard Standard

Philips

Reconstruction Field of view [mm] 350 250

parameters
Reconstruction filter B UB

Slice width [mm] 3 5

Generation of DW,IMP for the water PHANTOMS

Large water Small water

phantom phantom

X-Ray tube voltage [kVp] 120 120

X-Ray tube current [mA] 30 30

X-Ray tube position Frontal Lateral

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Incisive CT User information 5- 29

5.11 Conditions to Achieve 1000 mGy CTDIvol (Peripheral)

Generation of DW,REF(z) for the anthropomorphic PHANTOM

Torso Head

CT conditions of kVp 120 120

operation
mAs 200 300

Pitch 1 0.4

Rotation Speed 0.75 0.5

Collimation 32*0.625 32*0.625

Resolution Standard Standard

Reconstruction Field of view [mm] 350 250

parameters
Reconstruction filter B UB

Slice width [mm] 3 5

Generation of DW,IMP(z) for the anthropomorphic PHANTOM

Torso Head

X-Ray tube voltage [kVp] 120 120

X-Ray tube current [mA] 30 30

X-Ray tube position Frontal Lateral

The anthropomorphic phantom model is PH-2B manufactured by Kyoto

Kagaku.

5.11 Conditions to Achieve 1000 mGy CTDIvol

(Peripheral)
It is impossible to achieve 1000 mGy in a single axial scan on the Incisive
CT. Helical scans cannot achieve 1000 mGy to the same position on the
patient, as the table is continuously moving during the scan. It is possible
to see 1000 mGy for repeated axial scans in the same location, such as
interventional scans or perfusion scans, so those types of scans will be the
focus here. Typically, these types of scans are done far below the
maximum mAs settings at each kVp.

5.11.1 Adult and Infant Head

The maximum peripheral CTDI is seen at the 12:00 peripheral position.
Using the maximum limits on tube mAs for each type of axial scan, the
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5 -3 0 User information Incisive CT

 Conditions to Achieve 1000 mGy CTDIvol (Peripheral) 5.11

maximum peripheral CTDI which can be achieved for Head Mode can be
summarized as follows. If the kVp, collimation, rotation time, and mAs are
different with the listed here, the number of rotations to exceed 1000
mGy will be changed proportionally, please refer normalized CTDI plots
in CTDI and dose analysis information, on page 5-13.

Brain Perfusion Non-Jog

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy

120 32x0.625 1s 667 112.1 9

Brain Axial

This scan is typically done with 10 mm scan increment, but can be set to 0
mm scan increment, which will scan the same location repeatedly. If so,
then the following maximum 12:00 CTDI values can be achieved.

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy
459801855482_A

120 16x0.625 1s 667 129.1 8

Axial HR Head

This scan is typically done with 10-15 mm scan increment, but can be set
Philips

to 0 mm scan increment, which will scan the same location repeatedly. If

so, then the following maximum 12:00 CTDI values can be achieved.

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy

120 2x0.625 0.5s 333 170.3 6

Adult and Infant Mode

The maximum peripheral CTDI is seen at the 12:00 peripheral position.

Using the maximum limits on tube mAs for each type of axial scan, the
maximum peripheral CTDI which can be achieved for Adult Body Mode
can be summarized as follows. If the kVp, collimation, rotation time, and
mAs are different with the listed here, the number of rotations to exceed
1000 mGy will be changed proportionally, please refer normalized CTDI
plots in CTDI and dose analysis information, on page 5-13.

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Incisive CT User information 5- 31

5.11 Conditions to Achieve 1000 mGy CTDIvol (Peripheral)

Body Perfusion

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy

120 32x0.625 1s 667 82.9 13

CCT Mode - CCT Single or CCT Continuous

It is possible to achieve high CTDI with CCT Modes. Both CCT Single
and CCT Continuous use 240 degree reconstruction, which reduces the
maximum mAs value. Utilizing similar limits as above, and choosing the
collimation which gives this highest peripheral CTDI, results in the
following table:

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy

120 16x0.625 0.75s 270 38.7 26

CCT Fluoro

CCT Fluoro is a continuous scan mode, and displays CTDI rate in mGy
per second (mGy/s). However, faster rotation times at the same mAs can
yield higher CTDI rates. Utilizing similar limits as above, and choosing the
collimation which gives this highest peripheral CTDI, results in the table
below. Note that the default CCT Fluoro scan is limited to 30 seconds,
but it is possible to extend or repeat the scan.

kVp Collimation Rotation Time mAs CTDI rate Number of scan seconds
(12:00 o'clock to exceed 1000 mGy
position)

120 4x0.625 0.4s 133 89 12

High Resolution Chest

This scan is typically done with 10-15 mm scan increment, but can be set
to 0 mm scan increment, which will scan the same location repeatedly. If
so, then the following maximum 12:00 CTDI values can be achieved.

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy

120 2x0.625 1s 667 252.5 4

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5 -3 2 User information Incisive CT

 Conditions to Achieve 1000 mGy CTDIvol (Peripheral) 5.11

Cardiac Step & Shoot

The maximum peripheral CTDI is seen at the 12:00 peripheral position.

Cardiac scans can be done with Step & Shoot mode, rescanning the same
location as many as three times. Due to the fast rotation speeds, and
scanning only 240 degrees for an axial scan, it is impossible to achieve
very high mAs values for these scans. Using the maximum mAs values for
cardiac mode gives the following results. The number of rotations to
exceed 1000 mGy are all much higher than three.

kVp Collimation Rotation Time mAs CTDI (12:00) Number of Axial scans to
exceed 1000 mGy

120 64x0.625 0.35s 250 27.8 36

120 32x0.625 0.35s 250 31.1 33

Note
Off-center Body Trauma is only available in helical scan mode.
459801855482_A
Philips

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Incisive CT User information 5- 33

 6 Recycling Passport

Incisive CT Scanner System

Product Name Incisive CT Scanner System

Total Weight (in Kg) 2525

Producer/Manufacturer Name Company: Philips Healthcare (Suzhou) Co., Ltd

Address: No. 258, ZhongYuan Road, Suzhou Industrial Park

Suzhou, Jiangsu Province

Zip Code: 215024

Country: People’s Republic of China

Recycle Info Items Location

Special attention Spring loaded cover Figure 2 (7), Figure 5 (3), Figure 6 (2), Figure 7
(2)
459801855482_A

Rotor unbalanced when a component is removed Figure 2 (1)

Actuators: Unstable when removed, possible Figure5 (1), Figure56 (1), Figure7 (1)
rotation of frame.

Fluids/Gases Items Location

Philips

Hydrocarbon oil in X-ray tube Figure 2 (3)

Hydrocarbon oil in HV generators Figure 2 (2)

Batteries Type Location

NiCd Batteries in console computer Figure 8 (2)

To be removed

Hazardous Substances Location

Printed circuit boards Figure 1 (1) (2), Figure2 (4) , Figure2 (5),
Figure2 (6), Figure3(1),Figure4 (1), Figure5 (2),
Figure6 (3), Figure7 (3), Figure8 (1),

To be removed Collimator-Lead Figure 2 (4)

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Incisive CT Recycling Passport 6-1

 Show locations of materials mentioned on the previous sheet.

Figure 1: Front View of Gantry with Cover on

Figure 2: Front View of Gantry with Cover Removed

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6 -2 Recycling Passport Incisive CT

 Figure 3: Rear View of Gantry with Cover Removed
459801855482_A
Philips

Figure 4: Left Side View of Gantry with Cover Removed

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Incisive CT Recycling Passport 6- 3

 Figure 5: Right Side View of Gantry with Cover Removed

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6 -4 Recycling Passport Incisive CT

459801855482_A

Figure 6: Left Side View of Gantry with Cover Removed

Philips

Figure 7: Fixed Couch without Cover

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Incisive CT Recycling Passport 6- 5

 Figure 8: Front View of Console Computer

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6 -6 Recycling Passport Incisive CT

 Bariatric Table (Option)
Product Name Bariatric Table

Total Weight (in Kg) 650

Producer/Manufacturer Name Company: Philips Healthcare (Suzhou) Co., Ltd

Address: No. 258, ZhongYuan Road, Suzhou Industrial Park

Suzhou, Jiangsu Province

Zip Code: 215024

Country: People’s Republic of China

Recycle Info Items Location

Special attention Removal of Motor & Screw brake & Failsafe: Couch Figure 10 (2), Figure 12 (1), Figure 13 (1)
will drop when motor & Screw brake & Failsafe are
removed simultaneously.

Fluids/Gases Items Location

None None
459801855482_A

Batteries Type Location

Philips

None None

To be removed

Hazardous Substances Location

Printed circuit boards Figure 10 (1), Figure 11 (1), Figure 12 (2), Figure
14 (1)

To be removed

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Incisive CT Recycling Passport 6- 7

 Show locations of materials mentioned on the previous sheet.

Figure 9: Full view of Patient Support without cover

Figure 10: Front view of Patient Support

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6 -8 Recycling Passport Incisive CT

459801855482_A

Figure 11: Left side of Patient Support

Philips

Figure 12: Top View of Patient Support Base

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Incisive CT Recycling Passport 6- 9

 Figure 13: Right side of Patient Support

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6 -1 0 Recycling Passport Incisive CT

 Figure 14: Top View of Patient Support
459801855482_A
Philips

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Incisive CT Recycling Passport 6- 11

 7 EURATOM Compliance Statement

For basic safety standards for protection against exposure to

ionising radiation. (Directive 2013/59/EURATOM)

Product Name: Refer to System label and IFU.

Device class: II b.

Company Name and Address: Refer to System labels and IFU.

Contact Information: Refer to System labels and IFU.

Target Users and Training: Refer to IFU.

Information on the residual risks, any adverse event and

precaution for use:
459801855482_A

The Philips Risk Management Process comply with ISO 14971 and is
applicable to all stages of the life cycle of the device. IFU contains the
warnings and precautions for use, applicable to safety of the product. The
Risk Management Process recognized hazards associated with the device
to estimate and evaluate all the associated risks. Identified risks associated
Philips

with the use of the device are mitigated and deemed acceptable when
weighed against the benefits to the patient. Information pertains to
residual risks, adverse events and precautions identified through the
instruction for use.

Device description: Refer to IFU.

The summary of the clinical evaluation results as mentioned in

article R.5211-36-1:

With respect to safety of the device, Clinical evaluations conducted

through clinical evaluation planning, identified equivalent devices, a
comprehensive analysis of available pre- and post-market clinical data to
ensure the safety and performance of the device intended use.
Furthermore, reviewed clinical data did not identify any risks specific to
the device, not assessed in the risk analysis. Therefore, the clinical

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Incisive CT EURATOM Compliance Statement 7-1

 evaluation concludes that the device will not compromise the clinical
condition or the safety of patients, or the safety of the users.

Conclusion:

1 The clinical safety and performance of the device was demonstrated

with the clinical evaluation;
2 Conformity with the relevant essential requirements is demonstrated
through technical documentation.

With respect to post market clinical follow up, no specific device features
or other aspects were identified that require special attention during the
post market phase. Post market surveillance monitoring activities (i.e.,
conducting a search in the literature and clinical experience databases)
related to the use of the device in the market are planned to obey our
internal processes.

For the list of the applicable Harmonized Standards, you can refer to the
Declaration of Conformity

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7 -2 EURATOM Compliance Statement Incisive CT

Philips Healthcare is part of Royal Philips © Koninklijke Philips N.V 2021
All rights are reserved. Reproduction or
transmission in whole or in part, in any form
or by any means electronic, mechanical or
www.healthcare.philips.com
otherwise, is prohibited without the prior
healthcare@philips.com written consent of the copyright owner.
Dell is a U.S. registered trademark of Dell
Computer Corp.
Philips Healthcare (Suzhou) Co., Ltd. Microsoft is a U.S. registered trademark of
Microsoft Corp.

Manufacturing address:
Philips Healthcare (Suzhou) Co., Ltd. C0123
No. 258, ZhongYuan Road, Suzhou Industrial Park
215024 Suzhou, Jiangsu Province
459801855482_A*8/2021
PEOPLE’S REPUBLIC of CHINA

Philips Medical Systems, Nederland B.V.

Veenpluis 6
5684 PC Best
The Netherlands

European importer
Philips Medical Systems
Nederland B.V.
High Tech Campus 52,
5656AG Eindhoven
The Netherlands

Copyright address:
Philips Medical Systems, Nederland B.V.
Veenpluis 6
5684 PC Best
The Netherlands