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DigitalDiagnost C90
User Manual
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Philips DigitalDiagnost C90 User Manual

Instructions for Use
English
DigitalDiagnost C90
Version 1.1
4512 987 46122 AA/712 * MAR 2020 - en-US
Version 1.1
Version 1.1
4512 987 46122 AA - en-US
4512 987 46122 AA - en-US
Version 1.1
4512 987 46122 AA - en-US
Version 1.1
Version 1.1
4512 987 46122 AA - en-US
4512 987 46122 AA - en-US
Version 1.1
Version 1.1
4512 987 46122 AA - en-US
4512 987 46122 AA - en-US
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
Philips 4512 987 46122 AA/712 * MAR 2020
www.philips.com/healthcare
Philips Medical Systems DMC GmbH Röntgenstraße 24 22335 Hamburg Germany
0123
© 2020 Koninklijke Philips N.V. 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 4512 987 46122 AA/712 * MAR 2020 - en-US

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
Prescription Device Statement....................................................................................................................... 16
Training........................................................................................................................................................... 16
Conformity...................................................................................................................................................... 17
Dangerous Substances....................................................................................................................... 17
Mercury (USA Only)........................................................................................................................... 17
Perchlorate........................................................................................................................................ 17
Reader Manufacturer's Address..................................................................................................................... 17
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
Error Messages............................................................................................................................................... 37
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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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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
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
8 Technical Data...................................................................................................................................... 257
System.......................................................................................................................................................... 257
Ambient Conditions......................................................................................................................... 257
Eleva Workspot............................................................................................................................................. 257
Generator...................................................................................................................................................... 257
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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
6 DigitalDiagnost C90 Version 1.1
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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
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Attaching the Belt............................................................................................................................ 310
DigitalDiagnost C90 Version 1.1 7
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
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Table of contents
10 DigitalDiagnost C90 Version 1.1
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Publication Details Worth Knowing
0123

Worth Knowing

1

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.
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:
Philips 4512 987 46122 AA/712 * MAR 2020
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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 action
⇨ Result produced by a step
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.
12 DigitalDiagnost C90 Version 1.1
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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-
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DigitalDiagnost C90 Version 1.1 13
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:
14 DigitalDiagnost C90 Version 1.1
Philips 4512 987 46122 AA/712 * MAR 2020
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.
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Worth Knowing Compatibility

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)

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
16 DigitalDiagnost C90 Version 1.1
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Conformity Worth Knowing
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
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Worth Knowing Reader Manufacturer's Address
18 DigitalDiagnost C90 Version 1.1
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Warnings and Cautions Safety and Requirements

Safety and Requirements

2

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.
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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DigitalDiagnost C90 Version 1.1 23
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
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.
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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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