Philips DigitalDiagnost C90 User Manual

Name: Philips DigitalDiagnost C90
Brand: Philips
SKU: 9269173
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Instructions for Use

English

DigitalDiagnost C90

Version 1.1

4512 987 46122 AA/712 * MAR 2020 - en-US

DigitalDiagnost C90

Version 1.1

DigitalDiagnost C90

Version 1.1

DigitalDiagnost C90

Version 1.1

4512 987 46122 AA - en-US

DigitalDiagnost C90

Version 1.1

DigitalDiagnost C90

Version 1.1

DigitalDiagnost C90

Version 1.1

DigitalDiagnost C90

Version 1.1

DigitalDiagnost C90

Version 1.1

4512 987 46122 AA - en-US

Contents of this folder

Instructions for Use

DigitalDiagnost C90 V.1.1

Eleva Workspot for DigitalDiagnost C90 V.1.1

Philips

DigitalDiagnost C90 V.1.1

4512 987 46122AA/712/2020 03

DigitalDiagnost C90

Instructions for Use

Version 1.1

4512 987 46122 AA/712 * MAR 2020

Philips

www.philips.com/healthcare

Philips Medical Systems DMC GmbH

Röntgenstraße 24

22335 Hamburg

Germany

0123

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.

Printed in Germany

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		Table of contents
Table of contents
1	Worth Knowing......................................................................................................................................	11
	Publication Details..........................................................................................................................................	11
	Compliance.....................................................................................................................................................	11
	About These Instructions for Use...................................................................................................................	12
	Intended Use...................................................................................................................................................	13
	Indications for Use..........................................................................................................................................	13
	Intended Operator Profile..............................................................................................................................	13
	Contraindications............................................................................................................................................	14
	Target Population...........................................................................................................................................	14
	Clinical Benefits...............................................................................................................................................	15
	Prohibited Use................................................................................................................................................	15
	Compatibility...................................................................................................................................................	16
2020	Prescription Device Statement.......................................................................................................................	16
2020	Training	16
* MAR	Training	16
* MAR	Conformity	17
AA/712	Conformity	17
AA/712	Dangerous Substances	17
	Dangerous Substances	17
46122	Mercury (USA Only)...........................................................................................................................	17
46122	Perchlorate........................................................................................................................................	17
987	Reader Manufacturer's Address	17
4512	Reader Manufacturer's Address	17
4512
2	Safety and Requirements........................................................................................................................	19
	Warnings and Cautions...................................................................................................................................	19
	Electrical Safety...............................................................................................................................................	21
	Mechanical Safety...........................................................................................................................................	23
	Special Mechanical Safety...............................................................................................................................	24
	Explosion Safety..............................................................................................................................................	27
	Fire Safety.......................................................................................................................................................	28
	Damage as a Result of Incorrect Cassette Insertion.......................................................................................	28
	Electrostatic Discharge (ESD)..........................................................................................................................	28
	Electromagnetic Compatibility........................................................................................................................	29
	Radiation Protection.......................................................................................................................................	32
	Radiation Dose Management.........................................................................................................................	33
	Laser Light Source...........................................................................................................................................	37
	In the Event of Power Outage.........................................................................................................................	37
Philips	Error Messages...............................................................................................................................................	37
Philips

DigitalDiagnost C90 Version 1.1

Table of contents
	At the Geometry................................................................................................................................	37
	At the Eleva Workspot.......................................................................................................................	38
	At the UPS (Optional)........................................................................................................................	40
3	System Description.................................................................................................................................	43
	System.............................................................................................................................................................	43
	System Components.......................................................................................................................................	44
	Eleva Workspot..................................................................................................................................	44
	UPS for Eleva Workspot (Optional)....................................................................................................	45
	Ceiling Suspension CSM3...................................................................................................................	49
	Remote Control for the Ceiling Suspension CSM3............................................................................	50
	Eleva Tube Head................................................................................................................................	53
	Display of the Eleva Tube Head.........................................................................................................	55
	Vertical Stand 2..................................................................................................................................	57
	DigitalDiagnost VM............................................................................................................................	64
	DigitalDiagnost TH2...........................................................................................................................	70
	Single-Sided Table TH-S.....................................................................................................................	73
	Fixed Detector...................................................................................................................................	75
	SkyPlate Detector..............................................................................................................................	76
	PCR S Plus Cassette Reader...............................................................................................................	86
4	Switching the System On/Off..................................................................................................................	91
	Switching On...................................................................................................................................................	91
	Logging In........................................................................................................................................................	92
	Quick Logout...................................................................................................................................................	93
	Switching Off...................................................................................................................................................	94
	Aborting the System.......................................................................................................................................	94
	Restarting the System.....................................................................................................................................	95
	Emergency Access to the System....................................................................................................................	95
	The PCR S Plus Plate Reader...........................................................................................................................	97
	UPS for Eleva Workspot (Optional)...............................................................................................................	100
	Installation.......................................................................................................................................	100
	Switching the System Off (Only for Service Reasons)......................................................................	100
	Switching the System On.................................................................................................................	101
	In the Event of a Power Outage.......................................................................................................	102
5	Operation.............................................................................................................................................	103
	Safety Awareness..........................................................................................................................................	103
	Workflow......................................................................................................................................................	103
	Quick Way to Great Exposures........................................................................................................	103
	If You Do not Follow the Usual Workflow.......................................................................................	104
	System Components.....................................................................................................................................	104
	Ceiling Suspension CSM3.................................................................................................................	104

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4	DigitalDiagnost C90 Version 1.1

		Table of contents
	Vertical Stand 2................................................................................................................................	131
	DigitalDiagnost VM..........................................................................................................................	137
	DigitalDiagnost TH2.........................................................................................................................	145
	Single-Sided Table TH-S...................................................................................................................	151
	Fixed Detector.................................................................................................................................	156
	SkyPlate Detector............................................................................................................................	163
	PCR S Plus Plate Reader...................................................................................................................	212
	Examinations.................................................................................................................................................	222
	Stitching (Optional)..........................................................................................................................	222
	Preparation at the Eleva Workspot.................................................................................................	222
	Positioning the System and the Patient...........................................................................................	223
	Releasing an Exposure.....................................................................................................................	227
	Postprocessing at the Eleva Workspot............................................................................................	229
6	Functions..............................................................................................................................................	231
	Defined Exposure Positions..........................................................................................................................	231
	PCR Integration.............................................................................................................................................	231

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7	Maintenance, Cleaning, and Disposal....................................................................................................	233
	Maintenance.................................................................................................................................................	233
	Planned Maintenance......................................................................................................................	233
	Repairs.............................................................................................................................................	233
	Recording Results............................................................................................................................	234
	User Routine Checks.....................................................................................................................................	234
	Obligations of the User....................................................................................................................	234
	Tests and Checks by the User..........................................................................................................	234
	Safety Checks According to the Medical Device Directive...............................................................	235
	Checking the AEC Function..............................................................................................................	236
	Checking the Dose Area Product Indication....................................................................................	237
	Performance Check of the Automatic Collimator............................................................................	237
	Cleaning and Disinfecting..............................................................................................................................	238
	Rules and Instructions.....................................................................................................................	238
	Types of Disinfectants......................................................................................................................	241
	Restrictions for Certain Types of Disinfectants................................................................................	244
	Special Instructions for Certain Components..................................................................................	245
	Product Disposal...........................................................................................................................................	253
	Passing the Product on to Another User.......................................................................................................	254
	REACH Requirements....................................................................................................................................	255

Philips

8	Technical Data......................................................................................................................................	257
	System..........................................................................................................................................................	257
	Ambient Conditions.........................................................................................................................	257
	Eleva Workspot.............................................................................................................................................	257
	Generator......................................................................................................................................................	257

DigitalDiagnost C90 Version 1.1

Table of contents
Electrical Data..................................................................................................................................	257
Exposure Techniques.......................................................................................................................	258
AEC Supervision (Fail Safe AEC).......................................................................................................	258
Setting Ranges.................................................................................................................................	259
Ambient Conditions.........................................................................................................................	259
Accuracy of the Operating Data, Tolerances...................................................................................	260
X-ray Tube Compatibility.................................................................................................................	261
Methods of Measurement..............................................................................................................	261
Labels...............................................................................................................................................	262
Ceiling Suspension CSM3..............................................................................................................................	262
Equipment Data...............................................................................................................................	262
Compatibility...................................................................................................................................	263
Labels...............................................................................................................................................	265
Vertical Stand 2.............................................................................................................................................	267
Equipment Data...............................................................................................................................	267
Compatibility...................................................................................................................................	267
Options............................................................................................................................................	267
Labels Vertical Stand 2.....................................................................................................................	268
DigitalDiagnost VM.......................................................................................................................................	269
Equipment Data...............................................................................................................................	269
Compatibility...................................................................................................................................	270
Labels...............................................................................................................................................	270
DigitalDiagnost TH2......................................................................................................................................	272
Equipment Data...............................................................................................................................	272
Compatibility...................................................................................................................................	272
Labels...............................................................................................................................................	273
Single Sided Table TH-S.................................................................................................................................	274
Equipment Data...............................................................................................................................	274
Compatibility...................................................................................................................................	274
Labels...............................................................................................................................................	276
Fixed Detector...............................................................................................................................................	276
SkyPlate Detector.........................................................................................................................................	277
Ambient Conditions.........................................................................................................................	277
Equipment Data...............................................................................................................................	277
Small SkyPlate in Incubator.............................................................................................................	279
Labels...............................................................................................................................................	280
Typical IQ Performance.................................................................................................................................	285
Ambient Conditions of the Measuring Chamber..........................................................................................	285
Grids for the Bucky Unit................................................................................................................................	286
Changeable Grids and Usable SIDs for the Bucky Unit....................................................................	286
Grids for the SkyPlate...................................................................................................................................	288
Changeable Grid Frames and Usable SIDs.......................................................................................	288
Technical Data.................................................................................................................................	289

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		Table of contents
	Patient Dose Calculation...............................................................................................................................	289
	Electromagnetic Compatibility (EMC) Data..................................................................................................	290
	Guidance and Manufacturer’s Declaration.....................................................................................	290
	WiFi..................................................................................................................................................	294
	PCR S Plus Cassette Reader...........................................................................................................................	295
	Equipment Data...............................................................................................................................	295
	Ambient Conditions.........................................................................................................................	297
	Labels...............................................................................................................................................	298
9	Accessories...........................................................................................................................................	299
	For Your Safety..............................................................................................................................................	299
	Parking Frame for Accessories......................................................................................................................	299
	Hand Grips....................................................................................................................................................	300
	Normal Use......................................................................................................................................	300
	Legend.............................................................................................................................................	300
	Installing..........................................................................................................................................	301
	Dismantling......................................................................................................................................	301
	Compatibility...................................................................................................................................	301
	Technical Data.................................................................................................................................	302
	Labels...............................................................................................................................................	302
	Lead Apron for Vertical Stand 2....................................................................................................................	302
	Normal Use......................................................................................................................................	302
	Prohibited Use.................................................................................................................................	302
	Legend.............................................................................................................................................	303
	Operation........................................................................................................................................	303
	Compatibility...................................................................................................................................	304
	Labels...............................................................................................................................................	304
	Side Bar.........................................................................................................................................................	304
	Normal Use......................................................................................................................................	304
	Prohibited Use.................................................................................................................................	305
	Legend.............................................................................................................................................	305
	Installing..........................................................................................................................................	305
	Dismantling......................................................................................................................................	306
	Technical Data.................................................................................................................................	307
	Compatibility...................................................................................................................................	307
	Labels...............................................................................................................................................	307
	Adjustable Straps..........................................................................................................................................	307
	Normal Use......................................................................................................................................	307
	Prohibited Use.................................................................................................................................	307
	Legend.............................................................................................................................................	308
	Installing..........................................................................................................................................	308
	Dismantling......................................................................................................................................	309
	Operation........................................................................................................................................	309
	Detaching the Belt...........................................................................................................................	309
	Attaching the Belt............................................................................................................................	310

DigitalDiagnost C90 Version 1.1

Table of contents
Technical Data.................................................................................................................................	310
Compatibility...................................................................................................................................	310
Labels...............................................................................................................................................	311
Compression Belt..........................................................................................................................................	311
Safety Instructions...........................................................................................................................	311
Normal Use......................................................................................................................................	311
Installing..........................................................................................................................................	311
Dismantling......................................................................................................................................	313
Compatibility...................................................................................................................................	313
Technical Data.................................................................................................................................	313
Labels...............................................................................................................................................	314
Infusion Bottle Holder...................................................................................................................................	314
Normal Use......................................................................................................................................	314
Prohibited Use.................................................................................................................................	314
Legend.............................................................................................................................................	315
Installing..........................................................................................................................................	315
Dismantling......................................................................................................................................	316
Technical Data.................................................................................................................................	316
Compatibility...................................................................................................................................	316
Labels...............................................................................................................................................	316
Paper Roll Holder..........................................................................................................................................	317
Normal Use......................................................................................................................................	317
Prohibited Use.................................................................................................................................	317
Legend.............................................................................................................................................	317
Installing..........................................................................................................................................	318
Dismantling......................................................................................................................................	319
Technical Data.................................................................................................................................	320
Compatibility...................................................................................................................................	320
Labels...............................................................................................................................................	320
Support for CPR (Cardio Pulmonary Resuscitation)......................................................................................	320
Normal Use......................................................................................................................................	320
Prohibited Use.................................................................................................................................	321
Legend.............................................................................................................................................	321
Operation........................................................................................................................................	321
Technical Data.................................................................................................................................	322
Compatibility...................................................................................................................................	322
Labels...............................................................................................................................................	322
Babix Holder..................................................................................................................................................	322
Normal Use......................................................................................................................................	322
Prohibited Use.................................................................................................................................	322
Legend.............................................................................................................................................	323
Installing..........................................................................................................................................	323
Operating.........................................................................................................................................	323
Technical Data.................................................................................................................................	324
Labels...............................................................................................................................................	324

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	Table of contents
Stretch Grip...................................................................................................................................................	325
Normal Use......................................................................................................................................	325
Prohibited Use.................................................................................................................................	325
Installing/Dismantling......................................................................................................................	325
Swiveling the Stretch Grip...............................................................................................................	326
Technical Data.................................................................................................................................	327
Compatibility...................................................................................................................................	327
Labels...............................................................................................................................................	327
Accessories for the SkyPlate Detector..........................................................................................................	328
Detector Handle..............................................................................................................................	328
Mobile Detector Holder...................................................................................................................	331
Detector Holder Patient Bed...........................................................................................................	338
Portable Panel Protector.................................................................................................................	346
WPD Hygienic Bags..........................................................................................................................	348
10 Appendix..............................................................................................................................................	351
Messages at the Eleva Tube Head................................................................................................................	351
Messages at the UPS (Optional)...................................................................................................................	366
Prompts...........................................................................................................................................	366
Warnings..........................................................................................................................................	367
Faults...............................................................................................................................................	367
Troubleshooting UPS Issues..........................................................................................................................	369
List of Symbols..............................................................................................................................................	371
Glossary........................................................................................................................................................	375
Index....................................................................................................................................................	377

DigitalDiagnost C90 Version 1.1

Table of contents

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Publication Details

Worth Knowing

1 Worth Knowing

Publication Details

Published by Philips Medical Systems DMC GmbH

Philips Medical Systems DMC GmbH reserves the right to make changes to both these Instructions for Use and to the product they describe. Product specifications are subject to change without notice. Nothing contained within these Instructions for Use is intended as any offer, warranty, promise or contractual condition, and must not be taken as such.

Compliance

This Medical Device meets the provisions of the European Medical Device Regulations.

0123

The wireless portable detector meets the provisions of the Radio Equipment Directive 2014/53/EU.

This Medical Device complies with the following standards:

•IEC 62304 Medical device software – Software life cycle processes

•IEC 62366 Application of usability engineering to medical devices

•ISO 14971 Application of risk management to medical devices

•IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements For Basic Safety And Essential Performance

•IEC 60601-1-2 Medical Electrical Equipment - Part 1–2: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

•IEC 60601-1-3 Medical Electrical Equipment – Part 1–3: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment

•IEC 60601-1-6 Medical Electrical Equipment – Part 1–6: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Usability

•IEC 60601-2-54 Medical Electrical Equipment – Part 2–54: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy

•NEMA PS 3.1 - 3.20 Digital Imaging And Communications In Medicine (DICOM) Set

•ISO 10993-1 Biological Evaluation Of Medical Devices – Part 1: Evaluation And Testing Within A Risk Management Process

If you have further questions regarding the applicable national or international standards, please address them to:

DigitalDiagnost C90 Version 1.1

Worth Knowing

About These Instructions for Use

Philips Medical Systems DMC GmbH

Quality Department

Röntgenstraße 24

22335 Hamburg

Germany

About These Instructions for Use

These Instructions for Use are intended to assist users in the safe and effective operation of the product described. Before attempting to operate the product, you must read these Instructions for Use, noting and strictly observing all WARNING and CAUTION notices. Pay special attention to all the information given and procedures described in the “Safety” section.

These Instructions for Use are part of the system. They shall be kept in the immediate vicinity of the system so that they are accessible at any time.

WARNING

A WARNING alerts you to a potential serious outcome, adverse event or safety hazard. Fail ure to observe a warning may result in death or serious injury to the user or patient.

CAUTION

A CAUTION alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious in jury, and/or cause environmental pollution.

NOTICE

A NOTICE is used to identify special advice, for example to assist the operator or to improve an operating sequence.

Condition for operation ► Single step in an actionResult produced by a step

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These Instructions for Use describe the most extensive configuration of the product, with the maximum number of options and accessories. Not every function described may be available on your product.

Philips

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Intended Use

Worth Knowing

Depending on the configuration, other Instructions for Use may be delivered with the system, and these should be consulted for safety instructions, calibration, test procedures and maintenance.

For installation, see the system's service documentation.

These Instructions for Use were originally drafted, approved and supplied by Philips in the English language.

Intended Use

The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

Indications for Use

The system is suitable for all routine radiographic examinations, including specialist areas such as intensive care, trauma, or pediatric work. Also advanced applications such as Bone Suppression shall be performed with the system.

Standard radiography procedures are, for example:

•X-ray examinations of the skeleton including skull, chest, spine, pelvis, upper extremities, lower extremities, etc.

•X-ray examinations of the lungs

•X-ray examinations of soft tissue such as abdomen

•Overview image of the whole spine in vertical and horizontal patient position

•Overview image of the complete leg in vertical and horizontal patient position

The user has the following exposure techniques available:

•Detector exposure with a vertical, horizontal and/or oblique radiation beam

•Free exposure technique for free SkyPlate detector

•Free exposure technique for CR systems of Philips or other vendors and film cassettes

•Manual exposure techniques: kV-mA-ms; kV-mAs; kV-mAs-ms

•Automatic exposure technique: AEC-kV-mA, AEC-kV with falling load

Intended Operator Profile

The system is used with different configurations. It is to be operated by radiographers (technologists). In some cases or countries it is to be operated by especially trained nurses or doctors when no radiographer is available. Radiographers mostly schedule, prepare, perform, and final-

Philips

DigitalDiagnost C90 Version 1.1

Worth Knowing

Contraindications

ize X-ray examinations and are responsible for the administrative work as well. The operator must be able to physically operate the system. This includes sufficient capabilities in hearing, vision, and mobility.

Minimum skills:

•Knowledge in westernized Arabic numerals

•Knowledge in general radiographic positioning and procedures

•Knowledge in anatomy

•Knowledge in radiation protection

•Knowledge in hygiene and basic infection control

The detailed qualifications required to operate an X-ray system are defined by local legal regulations.

Contraindications

No absolute contraindications are given for standard radiology. Due to the nature of X-ray procedures, the patient is exposed to radiation. Adverse health effects exist and are well known. Therefore, the responsible radiologist must assess risks and benefits. The radiologist must identify relative contraindications, depending, for example, on available alternative diagnosis technologies.

Target Population

The DigitalDiagnost system is intended to support examinations on any kind of patient group (all patients that enter the facility). Patients might be handicapped, immobile or frightened. There are situations when it is indicated to avoid any unnecessary movement of the patient (for example, multiple traumas). Typically, the patients are ill or suspected to be ill.

Patients can be:

•Very young or very old (from newborn to >100 years)

•Heavily injured (fractures, brain lesion, bleeding)

•Unconscious

•Deranged

•Handicapped or disabled

•Under influence of drugs

Their physical appearance might be:

•Up to 2.20 m tall (86.6 in)

•Very small (for example, babies)

•Heavy (up to 375 kg [827 lb])

Immobile or handicapped patients might come by:

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Philips

Clinical Benefits

Worth Knowing

•Wheelchair

•Stretcher

•Bed

Clinical Benefits

Plain radiography can provide detailed information to diagnose, plan treatment and evaluate many conditions in adults and children. The DigitalDiagnost C90 system allows convenient and reliable handling of standard radiographic examinations. In combination with state of the art flat panel detectors and software, the system significantly minimizes the radiation exposure of patients and personnel due to low dose exposure techniques. The detailed images provided by X-ray imaging may eliminate the need for exploratory surgery. Furthermore, a software program tracks the patient doses for effective dose management in each clinic. The implemented Bone Suppression feature improves the detection of abnormalities in chest radiographs (for adult patients in erect position) and can increase the diagnostic value of the examination.

Stitching

Stitching of X-ray images is of interest in case of disease patterns like scoliosis or asymmetries in the structure of leg bones. Under circumstances like these, a measurement of the leg or spine as a whole is necessary.

SkyFlow

Scatter correction algorithm: It reduces the effect of scattered radiation for bedside chest examinations without grid. It saves time with grid-less workflow and benefits from automatic image contrast enhancement.

UNIQUE 2

Philips has redesigned the image processing algorithm (UNIQUE) for X-ray projection images. UNIQUE is a multiscale enhancement algorithm, which decomposes a radiograph into separate channels representing structures of different sizes (“scales”). At each scale, the contrast of the structures may be enhanced individually, which allows to achieve a good representation of all clinically relevant image details in the resulting image. Compared to its predecessor, the redesigned version (UNIQUE 2) features several technical improvements, such as an improved global contrast enhancement and a more sophisticated noise suppression.

Prohibited Use

The display of the Eleva Tube Head and the monitor of the Eleva Workspot are not suitable for routine diagnostic image reading.

The cassette reader is not allowed to work with cassettes and imaging plates other than specified.

DigitalDiagnost C90 Version 1.1

Worth Knowing

Compatibility

CAUTION

Do not use the product in combination with other products or components unless such oth er products or components are expressly recognized as compatible by Philips.

A list of such products and components is available from the manufacturer.

Changes and/or additions to the product should only be carried out by Philips or by third parties expressly authorized by Philips to do so. Such changes and/or additions must comply with all applicable laws and regulations that have the force of law within the jurisdictions concerned, and with best engineering practice.

WARNING

Changes and/or additions to the product that are carried out by persons without the appro priate training, and/or using unapproved spare parts, may lead to the Philips warranty being voided. As with all complex technical products, maintenance by persons not appropriately qualified and/or using unapproved spare parts carries serious risks of damage to the product and of personal injury.

Prescription Device Statement

CAUTION

Federal law restricts this medical equipment to sale by or on the order of a physician. (Unit ed States only)

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Training

Users of this product must have received adequate training on its safe and effective use before attempting to operate the product described in these Instructions for Use. Training requirements for this type of device will vary from country to country. Users must make sure they receive adequate training in accordance with local laws or regulations. If you require further information about training in the use of this product, please contact your local Philips representative or

Philips Medical Systems DMC GmbH Röntgenstraße 24

22335 Hamburg Germany

Philips

16	DigitalDiagnost C90 Version 1.1

Conformity

Worth Knowing

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Lamps in display contain mercury - dispose properly

WARNING

Risk of misdiagnosis

The incorrect use of image processing functions can give rise to false information in the image. Image information of relevance to diagnosis may be suppressed or misrepresented. You must have expert knowledge of digital image processing to change processing protocol settings.

Conformity

Dangerous Substances

This product may contain substances of very high concern (SVHCs).

According to EU requirements (REACH) Philips provides detailed information at www.philips.com/about/sustainability/reach

This information will be regularly updated.

Mercury (USA Only)

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 display contain mercury.)

Perchlorate

The product meets the provisions and statutes effective in California. It contains perchlorate.

For further information please visit www.dtsc.ca.gov/hazardouswaste/perchlorate

Reader Manufacturer's Address

FUJIFILM Corporation

26-30, Nishiazabu 2-Chome, Minato-ku

Tokyo 106-8620, Japan

Philips

DigitalDiagnost C90 Version 1.1

Worth Knowing

Reader Manufacturer's Address

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Warnings and Cautions

Safety and Requirements

2 Safety and Requirements

Warnings and Cautions

WARNING

Maintenance and faults

Do not use the product for any application until you are sure that the user routine checks have been satisfactorily completed, and that the periodic maintenance of the product is up to date. If any part of the product is known (or suspected) to be defective or wrongly adjust ed, do not use the product until a repair has been made. Operation of the product with de fective or wrongly adjusted components could expose the user or the patient to radiation or other safety hazards. This could lead to fatal or other serious personal injury, clinical mis diagnosis or clinical mistreatment.

Safety awareness

Do not use the product 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 product without a proper awareness of how to use it safely could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis or clinical mistreatment.

Never attempt to remove, modify, override or obstruct any part of the product. Product changes by unauthorized personnel could lead to fatal or other serious personal injury.

Adequate training

Do not use the product 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 product safely and effectively do not use it. Operation of this product without proper and adequate training could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis or clinical mistreatment.

Do not operate the product with patients unless you have an adequate understanding of its capabilities and functions. Using this product without such an understanding may compro mise its effectiveness and/or reduce the safety of the patient, you and others.

Safety devices

Never attempt to remove, modify, override or obstruct any safety device on the product. Interfering with safety devices could lead to fatal or other serious personal injury.

Intended use and compatibility

Do not use the product for any purposes other than those for which it is intended. Do not use the product with any product other than that which Philips recognizes as compatible. Operation of the product for unintended purposes, or with an incompatible product, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis or clinical mis

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Safety and Requirements

Warnings and Cautions

treatment.

You may use this medical equipment only in compliance with the safety instructions in these Instructions for Use and not for purposes other than those for which it is intended.

The user is always responsible for conforming to the regulations that apply to the setup and operation of medical equipment.

WARNING

•Philips accepts responsibility for the safety features of its products only if maintenance, repairs, and modifications are performed by Philips or persons explicitly authorized to do so by Philips.

•As with any technical appliance, this medical equipment also calls for proper operation and regular competent maintenance and care, which are described in the section “Main tenance, Cleaning and Disposal.”

•In the event of incorrect operation or maintenance of medical equipment, Philips cannot be held liable for any resulting faults, damage, or injuries.

•Even if no error message appears, but the medical equipment does not function as usual (first signs of a defect), customer service must be informed.

•Safety circuits may not be removed or modified in any way.

•You must not use this medical equipment if it has any electrical or mechanical defects. This applies, particularly, to faults in indicators, displays, warnings, and alarms.

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WARNING

Only especially trained and authorized technicians are allowed to service the Bucky unit.

CAUTION

Do not exceed the ambient conditions.

NOTICE

No part of the system shall be serviced or maintained while in use with a patient.

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Electrical Safety

Safety and Requirements

NOTICE

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.

“Serious incident” means any incident that directly or indirectly led, might have led or might lead to any of the following:

•The death of a patient, user or other person

•The temporary or permanent serious deterioration of a patient's, user's or other person's state of health

•A serious public health threat

Electrical Safety

According to IEC 60601-1 this medical equipment is classified as Class I ME equipment and applied parts are classified as Type B applied parts.

WARNING

Do not remove covers or cables from this product unless expressly instructed to do so in these Instructions for Use.

CAUTION

Do not operate the system adjacent to or stacked with other equipment.

If you connect parts of a system to a power strip, contact Philips service first. Connect only parts of the same system to one power strip. Safeguard unused sockets of the power strip.

This medical equipment may be operated only in medical rooms which meet IEC requirements.

Protection Against Entering of Liquids

This medical equipment meets class IPX0 according to IEC 60529 (no special protection). According to IEC 60601-1 sub-clause 7.2.9, no label and no note is required.

WARNING

The medical equipment is not protected against entering of liquids. Do not allow liquids to enter the medical equipment described.

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Safety and Requirements

Electrical Safety

Protection Against Entering of Liquids Wireless Portable Detector

The large wireless portable detector meets Class IP41 according to IEC 60529 (resistant against dripping water).

The small wireless portable detector meets Class IP43 according to IEC 60529 (resistant against spraying water).

NOTICE

Fluids may get under the rim, but not inside the wireless portable detector. To protect the wireless portable detector from contamination with dirt or germs you may use protective bags.

Protection Against Entering of Liquids Foot Switch TH S

The foot switch meets the class IPX7 according to IEC 60529 and is resistant against immersion up to 1 m.

Uninterruptable Power Supply (UPS)

The optional uninterruptable power supply (UPS) protects the Eleva Workspot from power outages.

CAUTION

After System Off, Emergency Off, Room Off, or Power down: If the UPS is installed, the Eleva Workspot will be under power even when the power is turned off.

NOTICE

Loss of images

Do not switch off the UPS directly after you have made an X-ray exposure. The image may not yet have been transferred from the detector to the Eleva Workspot.

Applied parts according to IEC 60601 1

Component	Applied part

DigitalDiagnost VM	•	Front cover
	•	Grips
	•	Stretch grip (accessory)

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Mechanical Safety

Safety and Requirements

Vertical Stand 2	•	Front cover
	•	Grips
	•	Stretch grip (accessory)

DigitalDiagnost TH2	•	Table top
	•	Compression belt (accessory)
	• Lateral cassette holder (accessory)

Single-Sided Table TH-S	•	Table top
	•	Adjustable straps (accessory)
	•	Side bar (accessory)

Wireless portable detector	Front cover

Ceiling Suspension CSM3	not applicable

Bucky units	not applicable

Patient Support	not applicable

Mechanical Safety

WARNING

•Do not remove covers or cables from this medical equipment unless expressly instructed to do so in these Instructions for Use.

•Be sure to keep all body parts or clothing free of the equipment to avoid getting caught or trapped within the moving components of this medical equipment.

•Remove all objects from the medical equipment’s radius of movement.

•Always be sure that audible and visual communication between the operator and patient are established throughout the entire examination. If necessary, communication must be maintained through technical means, for instance, an intercom.

•Make sure that ceiling mounted components you are not using (monitor suspension, X ray tube) are positioned in such a way that neither staff nor patients can be injured by them.

•Observe that components used above the patient (for example ceiling suspension) may cause hazards due to loose or defective parts, or accessories not used as prescribed. For details, see chapter Maintenance.

•You may not transport this medical equipment while it is in operation. Shut down the medical equipment before transportation and ensure that all peripheral parts of the sys tem (monitor, mouse, keyboard, cables, etc.) are disconnected and transported safely.

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Safety and Requirements

Special Mechanical Safety

Only non-allergenic materials are used.

Special Mechanical Safety

CAUTION

Risk of trapping fingers

To avoid injury always be careful during manual or motorized movements.

CAUTION

Patient may get caught between the table and the ceiling suspension

•When moving the table top upwards and when the X ray tube assembly is very low, be sure the patient is not trapped between the table and the X ray tube assembly.

•When moving the table top horizontally, be sure the patient is not trapped between the table and the vertically tilted X ray tube assembly beside the table.

•When moving the table top downwards and tracking is active, be sure the patient is not trapped between the table and the X ray tube assembly.

•When moving the ceiling suspension downwards, be sure the patient is not trapped be tween the table and the X ray tube assembly.

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Special Mechanical Safety

Safety and Requirements

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CAUTION

Patient may get caught between the table and the detector unit of the wall stand

•When you move the detector of the wall stand upward underneath the table, be sure the patient is not trapped between the table and the detector.

•When you tilt the detector of the wall stand, be sure the patient is not trapped between the table and the detector.

•When the detector of the wall stand is in horizontal position under the table and if the table deflects due to a very heavy load, the patient’s hands may get caught between the table and the detector.

•When moving the wall stand manually horizontally towards the table, be sure the patient is not trapped between the table and the vertically tilted detector unit.

•When swiveling the detector unit of the wall stand VM manually, be sure the patient is not trapped between the table and the vertically tilted detector unit.

•When swiveling the detector arm of the wall stand VM manually, be sure the patient is not trapped between the table and the vertically tilted detector unit.

•When moving the table top manually horizontally towards the wall stand, be sure the pa tient is not trapped between the table and the vertically tilted detector unit.

Philips

DigitalDiagnost C90 Version 1.1

Safety and Requirements

Special Mechanical Safety

CAUTION

Patient may get caught between the ceiling suspension and the detector of the wall stand

•When tilting the detector unit, be sure the patient is not trapped between the ceiling sus pension and the detector unit.

•When moving the vertical stand manually horizontally towards the ceiling suspension, be sure the patient is not trapped between the ceiling suspension and the vertically tilted detector unit.

•When rotating the detector unit of the VM manually along the column height axis, be sure the patient is not trapped between the ceiling suspension and the vertically tilted detector unit.

CAUTION

Patient may get caught between the wall and the detector of the wall stand

•When moving the vertical stand manually horizontally towards the wall, be sure the pa tient is not trapped between the vertically tilted detector unit and the wall.

•When swiveling the detector unit of the wall stand VM manually, be sure the patient is not trapped between the wall and the vertically tilted detector unit.

•When swiveling the detector arm of the wall stand VM manually, be sure the patient is not trapped between the wall and the vertically tilted detector unit.

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