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DigitalDiagnost C90
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User Manual
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Philips DigitalDiagnost C90 User Manual

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Page 1
Instructions for Use
English
DigitalDiagnost C90
Version 1.1
4512 987 46122 AA/712 * MAR 2020 - en-US
Page 2
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
Page 3
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
Page 4
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
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DigitalDiagnost C90
Instructions for Use
Version 1.1
Philips 4512 987 46122 AA/712 * MAR 2020
Page 6
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
Page 7

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
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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
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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
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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:
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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.
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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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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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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
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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
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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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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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Explosion Safety Safety and Requirements
CAUTION
Risk of injury
• When moving the detector downward, be sure that the patient is not trapped between the detector and the floor.
• Be sure the patient's hands are not in the range of the detector movement of the patient table TH2.
• When the patient gets off of the table, be sure he or she is not caught in the patient grips of the detector unit.
• When the grid is only partly removed from the detector unit, be sure the patient does not collide with it during automatic movements of the wall stand or the patient table TH2.
NOTICE
In addition to the special mechanical safety notes in this chapter, also observe all safety in­structions in the following chapters.

Explosion Safety

WARNING
Do not use this product in the presence of explosive gases or vapors. Do not use this product in the presence of an oxygen‐rich environment or an inflammable anesthetic mixture with air, oxygen or nitrous oxide. Using this product in an environment for which it was not de‐ signed can lead to fire or explosion. This medical equipment is not AP or APG equipment (anaesthetic‐proof or anaesthetic‐proof category G [gas]).
WARNING
Detergents and disinfectants, including those used on patients, may create explosive mix‐ tures of gases. Please observe the relevant regulations.
WARNING
Do not use flammable or potentially explosive disinfecting sprays. Such sprays create va‐ pors, which can ignite, causing fatal or other serious personal injury.
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Safety and Requirements Fire Safety

Fire Safety

WARNING
• You must never operate this medical equipment in areas where there is a risk of fire.
• If it is safe to do so, isolate the product from electrical and other supplies before at‐ tempting to fight a fire. This will reduce the risk of electric shocks.
WARNING
Ventilation apertures must not be covered while the equipment is switched on.
WARNING
On electrical or chemical fires use only extinguishers which are specifically labelled for those purposes. Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury.
WARNING
This medical equipment is not AP or APG equipment (anaesthetic‐proof or anaesthetic‐proof category G [gas]).

Damage as a Result of Incorrect Cassette Insertion

Always slide the cassettes into the cassette compartment of the reader with care. Incorrect in­sertion of a cassette, for instance if it is at an angle, can damage the reader. Please observe the instructions in chapter “Operation.”

Electrostatic Discharge (ESD)

CAUTION
Always use proper static procedures, protection, and products prior to opening and during handling of this product. This product contains components that are electrostatic sensitive. Failure to use ESD procedures may cause damage to these components. Such damage to components is not covered by Philips warranties.
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Electromagnetic Compatibility Safety and Requirements
Connections to sensitive parts are identified by the ESD warning symbol as shown.
Electrostatic discharge (ESD) can amount to a significant voltage, which may cause damage to Printed Circuit Boards (PCB) or other systems.
ESD damage is cumulative and may not be apparent at first, as indicated by a hard failure, but can cause degraded performance. Therefore, always use proper ESD handling procedures. ESD can result from low humidity condition or use of electrical equipment on carpeting, linens, and clothing.

Electromagnetic Compatibility

WARNING
Medical electrical equipment needs special precautions regarding EMC and needs to be in‐ stalled and put into service according to the EMC information provided in the accompanying documents. In accordance with its purpose, this device fulfills the regulations of the EMC legislation which govern the permissible emission of electromagnetic fields from electrically operated equipment and the immunity to be fulfilled. Despite this, it cannot be excluded with absolute certainty that radio signals from high‐fre‐ quency transmitters, such as mobile phones or similar mobile radio equipment, which also satisfy the EMC regulations will not influence the proper functioning of electro medical equipment when these are operated in direct proximity with relatively high transmitting power. The operation of such radio equipment should, therefore, be avoided in close prox‐ imity to electronically regulated or controlled medical products in the face of possible func‐ tional interference.
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Explanation
Electronic equipment which conforms to the EMC regulations is configured in such a way, that under normal circumstances, malfunctions caused by electromagnetic interference can be ex­cluded. However, with regard to radio signals from high-frequency transmitters with a relatively high transmitting power, which are operated in close proximity to electronic devices, the occur­rence of possible electromagnetic incompatibility with the electronic device cannot be com­pletely ruled out.
With unusual configurations, this could result in unintentional operating sequences being initi­ated in the device and, under certain circumstances, undesirable risks for patient or operator.
Therefore, the activation of any transmission from mobile radio equipment – this also applies to equipment in standby mode – is to be avoided.
Mobile phones must be switched off in marked problem areas.
Page 34
Safety and Requirements Electromagnetic Compatibility
For further information see chapter “Technical Data.”
WiFi Connectivity of the Wireless Portable Detector
The detector uses standard WiFi technology for data transfer to the workstation. This technolo­gy is proven to be safe in combination with current pacemakers. However it can not be com­pletely excluded that an older pacemaker or other EMC sensitive life-supporting device be influ­enced by the WiFi emission if operated in close proximity to the detector.
WARNING
WiFi technology is used by the wireless portable detector for data transfer. Due to the WiFi emission, special care must be taken when using the wireless portable detector close to life‐ supporting devices. In this respect observe the following rules:
• The life‐supporting device should be certified according to IEC 60601‐1‐2. This standard defines the minimum distance for a given maximum emission power, corresponding to a maximum instantaneous electrical field of 10 V/m. Customers have to take into account, on their own responsibility, that older life‐supporting devices do not necessarily satisfy the IEC 60601‐1‐2 criteria.
• Make sure that you keep the minimum distance to a life‐supporting device. Take into consideration that a strict compliance with IEC 60601‐1‐2 requires the following distances at the given emission power:
SkyPlate Detectors
WiFi component Emission frequency
Wireless portable SkyPlate
detector
2.4 GHz 17 mW 30 cm (11.8 in)
5 GHz 13 mW 26 cm (10.2 in)
1
Maximum WiFi emission
power
Minimum distance to life
supporting devices
SkyPlate E Detector
WiFi component Emission frequency
Wireless portable SkyPlate
E detector
1)
The WiFi connection of the internal network can be configured for 2.4 GHz or 5 GHz bands. It
2.4 GHz 15.27 mW 29 cm (11.4 in)
5 GHz 38.02 mW 45 cm (17.7 in)
1
Maximum WiFi emission
power
Minimum distance to life
supporting devices
is recommended to use the 5 GHz band since this can be expected to show less EMC effects.
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Electromagnetic Compatibility Safety and Requirements
WARNING
Special consideration for pacemakers
WiFi technology is proven to be safe in combination with current pacemakers. However it cannot be completely excluded that an older pacemaker or other EMC sensitive life‐support‐ ing device be influenced by the WiFi emission if operated in close proximity to the wireless detector.
• If you suspect that there will be an EMC interaction between the detector and a pace‐ maker or life‐supporting device, switch off the WiFi connection and use the cable connec‐ tion.
WARNING
The SkyPlate E detector uses NFC technology to attach the grid. Due to the magnetic field emission from the NFC, special care must be taken when using the SkyPlate E detector close to life supporting devices.
Keep a minimum distance of 1.6 cm between the NFC module (in detector and grid) and the patient wearing a pacemaker. If you observe any unusual symptoms on the pacemaker, remove all devices with an NFC module from the direct patient surrounding.
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Safety and Requirements Radiation Protection

Radiation Protection

CAUTION
This product may contain radioactive material or generate ionizing radiation.
Ensure that before each X‐ray exposure all the necessary radiation protection measures have been taken.
When using X‐radiation the personnel in the examination room must comply with the valid radiation protection regulations. In this respect please observe the following rules:
• Distance is the most effective radiation protection. Keep as large a distance as possible from the object exposed and the X‐ray tube assembly.
• Avoid working in the direct beam of radiation. If this is inevitable, protect yourself. Wear radiation protection gloves.
• Select as short an examination time as possible. This will reduce total radiation dose con‐ siderably.
• Move the region of interest as close as possible to the image intensifier/film cassette/ detector. Apart from reducing exposure to radiation you will also optimize the exposure.
• Always be aware that any material brought into the path of radiation between the pa‐ tient and the image receptor will have a negative influence on the image quality as well as on the patient dose.
• Safety circuits which may prevent X‐radiation from being switched on under certain con‐ ditions may be neither removed nor modified.
CAUTION
To protect the patient against radiation always use radiation protection accessories in addi‐ tion to devices which are fitted to the X‐ray equipment.
CAUTION
Wear protective clothing. Radiation protection aprons with a lead equivalent of 0.35 mm at‐ tenuate X‐radiation at 50 kV by 99.84%, and at 100 kV by 91.2%.
CAUTION
Always use the smallest X‐ray field collimation. Scattered radiation is largely dependent on the volume of the object being exposed.
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Radiation Dose Management Safety and Requirements
CAUTION
Always make sure that the X‐ray field collimation completely covers the selected measuring field.
CAUTION
Always select a focal spot to skin distance as large as possible to keep the absorbed dose for the patient as low as reasonably possible.
CAUTION
To avoid unwanted or excessive radiation, always be sure that the path of radiation corre‐ sponds with the selected registration device. Example: If the table detector is selected at the Eleva Workspot, do not expose on the detector of the wall stand.
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CAUTION
There should be no persons other than the patient in the examination room during X‐ray exposure. If circumstances require another person to enter the room while X‐ray exposures are planned or possible, that person should wear a lead apron in accordance with accepted radiation protection practices.
NOTICE
Unwanted or excessive radiation
Always select the correct measuring field for the examination. Make sure that the measuring field always corresponds with the region of interest and is fully covered by the body. Other­wise you may cause unwanted or excessive radiation.

Radiation Dose Management

This system supports different means of quantitative and qualitative dose management:
Clinical Protocols
A set of default clinical protocols is available on the system. These examination protocols are recommendations for adequate operation of the equipment according to its intended use. The protocols contain parameters for image generation, image processing, and display. They pro­vide reasonable image quality at sufficiently low dose levels according to the ALARA principle (As Low As Reasonably Achievable). The EPX validation and administration tool allows the ad­vanced user to manage the examination protocols. Default protocols can be complemented with more specific ones. Protocol parameters can be displayed, exported, and printed.
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Safety and Requirements Radiation Dose Management
Dose Area Product Indication
With the dose area product (DAP), the radiation dose applied to the patient is reported. The DAP for each image is displayed under each image. The cumulated DAP is displayed in the gen­erator area. The value is the product of the average dose and the irradiated area. Therefore, it is independent of the distance from the X-ray source.
Detector Dose Indication
The radiation dose at the image receptor is indicated by the exposure index EI_s. Deviations from the target dose at the image receptor are visualized in the user interface.
Quality Assurance Tool
The Quality Assurance Tool (QA Tool) provides several, configurable overviews of the examina­tion parameters and the radiation dose when using digital detectors. It can be used for a statis­tical analysis of radiographic exposures in regard to quality sensitive parameters. It provides analyses for internal quality control, for workflow improvements, and for reports to public au­thorities. The QA tool offers predefined analyses on important QA parameters, for example, on the dose information provided by the EI_s
values and on the DAP level. You may select the pa­rameters to be analyzed. The QA tool is optional for the Eleva Workspot. The corresponding license must be installed.
Quantitative Dose Estimation
The expected radiation quantity for each examination can be calculated from the X-ray parame­ter presets contained in the EPX database, but the exact amount of radiation dose applied to patients depends on the specific exposure settings. It can be simulated by exposing water equivalent phantoms according to IEC 60601-2-54. Diagnostic reference levels can be used for orientation and comparison purposes, see ICRP, 2017. Diagnostic reference levels in medical imaging. ICRP Publication 135. Ann. ICRP 46(1).
Examples of diagnostic reference levels publish-
ed by national and international organizations are:
• IPEM/NRPB/RCR/CoR/BIR Diagnostic Reference Levels Working Party (United Kingdom)
• ACR Practice Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging (USA)
• Code 35: Safety Procedures for the Installation, Use and Control of X-ray Equipment in Large Medical Radiological Facilities - Section A 3.5 Diagnostic Reference Levels (Canada)
• Bundesamt für Strahlenschutz: Bekanntmachung der aktualisierten diagnostischen Refer­enzwerte für diagnostische und interventionelle Röntgenuntersuchungen (Germany)
In general, the typical patient dose remains considerably below those diagnostic reference lev­els. The following table states mean values of dose area product and the associated range of variation caused by differences in, for example, patient type or by specific preferences regard­ing exposure settings and protocols. These values are based on a sample of 93122 exposures taken in 11 European and US hospitals (compare Radiation Protection Dosimetry, Vol. 114, Nos 1-3, pp. 131-134, 2005).
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Radiation Dose Management Safety and Requirements
Body part Dose area product [µGym²]
Mean value Range of variation
From To
Pelvis ap 84,0 47,3 248,8
L-spine ap 82,6 44,7 157,2
L-spine lat 128,3 69,6 276,9
Skull lat 19,0 6,1 31,3
Skull ap/pa 24,8 13,7 37,0
Chest pa 7,5 5,3 20,9
Chest lat 24,9 15,3 59,4
Radiation Dose and System Imaging Performance
The European Commission Radiation Protection N° 162 report “Criteria for Acceptability of Medical Radiological Equipment” (RP162) defines a set of quality criteria and suspension levels for diagnostic radiology equipment.
The document “Leitlinien der Bundesärztekammer zur Qualitätssicherung in der Röntgendiag­nostik” (“X-ray diagnostics guidelines for quality assurance by the federal medical association, Germany”) relates criteria for acceptability according to RP162 to the intended use as follows:
Intended use Radiation dose level System imaging performance
Radiography examinations with digi-
tal radiation detectors
Peripheral Skeleton ≤ 10 µGy ≥ 2,8 Lp/mm
Trunk ≤ 5 µGy ≥ 2,4 Lp/mm
Position control
Pediatric examinations
Detector dose Limiting spatial resolution
≤ 2,5 µGy ≥ 2,0 Lp/mm
This equipment complies with the criteria shown in the table as well as with further, system­related metrics of imaging performance defined in RP162 and the referenced documents.
Typical Patient Entrance Dose Values for Pediatric Extremities
The following table shows typical values of the patient entrance dose for exposures on the wall stand with an SID of 100 cm (39.4 in) and no added filter. The dose values are calculated from the typical yield of the X-ray tube.
For further information, see the Philips White Paper “Optimizing image quality and dose in digi­tal radiography of pediatric extremities”.
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Safety and Requirements Radiation Dose Management
Body part Patient
type
kV mAs (R20) Typical pa‐
EI_T: 500 EI_T: 250
kV mAs (R20) Typical pa‐
tient en‐
trance
dose [μGy]
tient en‐
trance
dose [μGy]
Hand ap Newborn 50 2.5 52 40 5.0 55
Baby 50 2.8 58 40 5.6 62
Child 50 3.1 65 40 6.3 69
Hand lat Newborn 50 2.8 58 40 5.6 62
Baby 50 3.1 65 40 6.3 69
Child 50 3.5 73 40 7.1 78
Wrist ap Newborn 50 3.1 65 40 6.3 69
Baby 50 3.5 73 40 7.1 78
Child 50 4.0 83 40 8.0 88
Wrist lat Newborn 50 4.5 94 40 11.2 123
Baby 50 5.0 104 40 12.5 138
Child 52 5.0 116 40 14.0 154
Foot
ap/obl
Newborn 50 4.0 83 40 9.0 99
Baby 50 4.5 94 40 10.0 110
Child 50 5.6 117 40 12.5 138
Foot lat Newborn 50 4.0 83 40 9.0 99
Baby 50 5.0 104 40 11.2 123
Child 50 6.3 131 40 14.0 154
Ankle ap Newborn 50 5.6 117 40 12.5 138
Baby 50 7.1 148 40 16.0 176
Child 55 6.3 168 40 20.0 220
Ankle lat Newborn 50 5.0 104 40 11.2 123
Baby 50 5.6 117 40 14.0 154
Child 55 5.0 133 40 18.0 198
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Laser Light Source Safety and Requirements

Laser Light Source

WARNING
Laser radiation
Some components of the system may contain laser light sources of Class 2 or lower. Make sure that no one looks directly into the light beam. With Class 2 lasers, the eye is protected by the eyelid closure reflex in the event of acciden‐ tal, brief glances into the laser beam. Therefore, Class 2 lasers may be used without taking any further precautions, if one of the following applies:
• It is not necessary to look into the beam intentionally for longer than 0.25 s.
• It is not necessary to look repeatedly into the laser beam or into the directly reflected beam.
For continuous‐duty Class 2 lasers, the maximum limit for accessible radiation is 1 mW.

In the Event of Power Outage

In the event of a power outage exposures are not possible.
Please note:
• Patients may be positioned only when the system is ready for operation again.
• Patients lying on the table top should remain there until the system is ready for operation again. If that is impossible, do the following:
– Move the table top on one side to the stops.
– Hold the table top steady when the patient is leaving it.
(Without power the table top is freely movable. Therefore, in small rooms the table top could block, for example, a passage for a trolley or the door of a cubicle).

Error Messages

At the Geometry
If an error is detected, a message appears in the display of the X-ray tube assembly.
► Write down the message and call customer service.
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► Restart the system. If the message does not appear again, continue working with the sys-
tem as usual.
Page 42
Safety and Requirements Error Messages
1
2
ERROR - .........................................................
.........................................................................
.........................................................................
OK
WARNING
Even if no error message appears, but the equipment does not function as usual (first signs of a defect), call customer service immediately.
At the Eleva Workspot
When an error has occurred in the system or in any part of it, an error message appears at the Eleva Workspot with instructions on how to correct it:
Legend Function Meaning What to do
1 Error message
All messages are listed in the In-
structions for Use for the Eleva
Workspot, chapter Appendix.
2
System status display
Blue: Everything OK
Yellow: Attention needed
Red: Fatal error
Click the status display: More infor-
mation appears.
► Click on status display.
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Error Messages Safety and Requirements
⇨ The device status is displayed. Example:
The following symbols may appear:
Symbol Meaning
Green circle:
Everything OK
Yellow triangle:
Attention needed
for example, printer needs attention
Red X:
Fatal error
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WARNING
Even if no error message appears, but the equipment does not function as usual (first signs of a defect), call customer service immediately.
Making Screenshots
When a message appears, you can save a screenshot of the message for customer service.
► Press SHIFT + F11.
⇨ This window appears:
► Enter a file name and press OK.
⇨ The screenshot is saved on the Eleva Workspot computer and can be accessed by author-
ized Philips Service engineers.
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Safety and Requirements Error Messages
8
At the UPS (Optional)
The following symptoms indicate that an error has occurred at the UPS (uninterruptable power supply):
• The fault indicator lights up.
• An audible alarm sounds.
No. Description
1 Fault indicator
2 to 7 Indicators for operating modes and programmable outlets
8 LCD panel
Indicator and LCD
In addition to the fault indicator, the LCD will display the fault. For the list of faults see the Ap­pendix.
NOTICE
When an error occurs at the UPS, the LCD backlight starts flashing as an alert after 2 minutes. Press any button to exit the alert mode. If you do not correct the fault, the LCD backlight will flash again until the fault is corrected.
Audible Alarm
An audible alarm will sound in conjunction with the visual indicators to indicate a change in the operating status of the UPS. The audible alarm will sound as described in the following table.
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Error Messages Safety and Requirements
Alarm Description
Continuous UPS fault, no power to load
Continuous Battery loss
Continuous Wiring problem (loss of proper grounding for UPS)
Half-second beep every half-second Overload
1-second beep every 4 seconds UPS fault, load on bypass
Two half-second beeps every 5 seconds Low battery
Half-second beep every 10 seconds Battery discharge
1-second beep every 60 seconds Bypass reminder
2-second beep every 2 minutes Battery replacement
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Safety and Requirements Error Messages
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System System Description
4
5
3
1
2
3
4
5
3

System Description

System

The system consists of several components that can be combined in various configurations to form X-ray systems.
Fig. 1: Eleva Workspot and two examples of configurations
1 Eleva Workspot with integrated generator control, PC (not shown), keyboard (not shown), and
touch screen
2 Hand switch for exposure release
3 Ceiling suspension CSM3
4 Wall stand:
• DigitalDiagnost VM with fixed detector (middle picture)
• Vertical Stand 2 with fixed detector or Bucky tray for the SkyPlate detector (right picture)
5 Patient table:
• DigitalDiagnost TH2 with fixed detector or Bucky tray for the SkyPlate detector (right picture)
• Single-sided table TH-S (middle picture)
Not shown Generator
SkyPlate wireless portable detector
SkyPlate E wireless portable detector
Patient Support (for stitching examinations) with accessories
Remote control for ceiling suspension CSM3
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Remote control for DigitalDiagnost VM
Remote control for Vertical Stand 2
Radiographic accessories
The Philips PCR S Plus reader is not sold any longer. Should a PCR S Plus reader be available at your facility, you can integrate it into your Philips DigitalDiagnost C90 system (optional).
Page 48
System Description System Components
1 2
The individual components are described in the following sections.

System Components

Eleva Workspot
Monitor Buttons
No. Function
1 – Switch on the Eleva Workspot and all other components.
– Restart the running Eleva Workspot by pressing the button for 4 s.
2 Switch off the Eleva Workspot and all other components.
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System Components System Description
1 2 3 4 5
Operator’s Console
You can select the sections using the main selector buttons (1‐5). When a section is selected the corresponding button turns yellow.
You can do the following in the sections:
No. Function Meaning
1 Patient list Enter patient and examination data (manually or via RIS connec-
tion) and select patient.
2 Examination Select the examination, set exposure data for generator and re-
lease X-ray.
3 Review Check and, if necessary, modify the image. You will find an over-
view of the patient's images and advanced image processing tools
here. You can export images to an archive.
4 Print You will find the printing tools here (optional).
5 System Log out of the system, perform calibration in the QA mode, create a
problem report, start the remote service access and remote service
assistance.
Administrator only: change customization.
UPS for Eleva Workspot (Optional)
About the UPS
Fig. 2: UPS (uninterruptable power supply)
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System Description System Components
The UPS (uninterruptable power supply) protects the Eleva Workspot from power outages. In the event of a power outage, the UPS will power the Eleva Workspot for approximately 100 minutes.
In case the UPS develops a problem, see the information on troubleshooting in the Appendix.
Operation and Display Panel
Fig. 3: Operation and display panel
No. Indicator/button Color Description
1 Fault indicator Red An error has occurred at the UPS.
2 Inverter indicator Green The inverter is supplying power.
3 Battery indicator Yellow Load is supplied by the battery.
4 Bypass indicator Yellow Load is supplied by the mains through automatic
or manual bypass.
5 Programmable-outlet 1 indicator Green Programmable outlet 1 is on.
6 Programmable-outlet 2 indicator Green Programmable outlet 2 is on.
7 ECO mode indicator Green UPS is in ECO mode.
8 Enter button – Enter the next level menu or confirm the parame-
ter setting value.
9 Down button – Move the cursor down or decrease the value dis-
played in the input data field.
When a menu is displayed on several screens,
press the button to scroll down.
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System Components System Description
No. Indicator/button Color Description
10 Up button – Move the cursor up or increase the value displayed
in the input data field.
When a menu is displayed on several screens,
press the button to scroll up.
11 Escape button – Return to the previous menu or abort any change
in the input data field before confirming.
12 LCD panel – The LCD panel shows the UPS status and enables
changes to the UPS.
Default Screen
In the default screen, the LCD shows the following information:
• UPS model
• Output parameters
• Input parameters
• Battery capacity with run time estimate
• Load percentage
The LCD will enter the screen-saver mode (backlight switches off) if no control button (ESC, Up, Down, Enter) is pressed for 2 minutes. Pressing any control button will switch the backlight on.
If the UPS does not display the default screen, you can move to the according menu level by pressing the Escape button.
Operating Modes
The UPS has the following operating modes:
Mains Mode
The mains mode is the default mode of the UPS. In this mode the power is provided by the mains. When the UPS is supplied with constant power, the batteries of the UPS remain fully charged.
Battery Mode
The UPS enters the battery mode when a power outage occurs or the UPS is not supplied with enough power. The battery ensures that the connected load is supplied with power. The bat­tery indicator lights up when the UPS enters the battery mode.
Battery Recharge Mode
During the battery recharge mode, the UPS recharges the batteries that have previously been discharged. This occurs as soon as the UPS is connected to the mains power again.
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System Description System Components
Bypass Mode
When the UPS is in bypass mode, the mains power bypasses the inverter. This means that the UPS provides the energy directly to the connected load. The UPS enters the bypass mode automatically when, for example, the inverter is faulty or the UPS overheats. Consequently, the UPS still supplies the connected load with power directly from the mains. The bypass mode is indicated through an audible alarm and the yellow bypass indicator on the operation and display panel.
ECO Mode
The ECO mode can be applied to increase efficiency and to reduce, for example, costs for elec­tricity. In this mode, the connected equipment is powered through the bypass path. The ECO mode is switched off by default.
Performing a Manual Battery Test
► Select Main menu/Control/Batt Test/Start.
► Confirm with Yes.
⇨ A user guidance indicates that the UPS performs the battery test.
or
⇨ The UPS displays the test result as either Passed
Failed.
► If the test result shows Failed, make sure that the UPS is supplied with power from the
mains and wait for the UPS to recharge the batteries (24 hours).
► Retest the batteries after 24 hours of charging.
► If the test result still shows Failed, contact customer service.
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Page 53
System Components System Description
4
1
2
3
Ceiling Suspension CSM3
Main Components
1 Ceiling suspension unit
2 Tube assembly
3 Collimator
4 Control grip
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System Description System Components
1
2
3
4
5
6
Function
The Ceiling Suspension CSM3 can be freely moved longitudinally and transversely. The tele­scoping column allows the tube assembly, collimator
and control grip to move vertically up
and down.
The directions of linear movements are color‐coded. You will find the colors on the corre­sponding buttons at the control grip and on the ceiling suspension unit. They are as follows:
1 Green Movement along the table top
2 Blue Movement at right angles to the table top
3 Yellow Raise/lower
4 White Tilt of tube assembly
5 White Rotation of the tube assembly
6 none Rotation of the collimator around the radiation beam axis
Remote Control for the Ceiling Suspension CSM3
The CSM remote control is available for systems that support automatic positioning of the ceil­ing suspension:
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System Components System Description
1
2
3
9
5
4
6 7 8
10
11
No. Symbol Meaning
1 Infrared transmitter: must be in line of sight with the infrared receiver in the ceiling suspension
2
3
4
5
Move to position: moves the system components to the defined position for the selected exposure
1
(view)
Tracking: activates tracking mode: the tube assembly height is automatically adjusted to maintain the set
SID (for table exposures) or the set detector alignment (for wall stand exposures)
Dead man's switch: press this switch and keep it pressed while you press the Move to position button
1
Open the radiation field transversely.
Close the radiation field transversely.
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System Description System Components
Memory
No. Symbol Meaning
Open the radiation field longitudinally.
Close the radiation field longitudinally.
Turn on the light field.
6
Collimator toggle function
• Last value set manually
• Automatic preset
7 Toggle the radiation field between portrait and landscape format.
8/9
(only with tracking);
Press once: The current collimation position is displayed.
Press again: Switch to the next collimation position: Top – Center – Bottom – Top ....
The LED for the corresponding collimation position lights up on the remote control and the tube height is
adjusted accordingly.
Top collimation (radiation field at top of detector field)
The top edge is fixed.
Centered collimation
The center is fixed.
Bottom collimation (radiation field at bottom of detector field)
The bottom edge is fixed.
10 Charge indicator
LED Battery status Remote control
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System Components System Description
1
2 3
4
5
679
12
13
14
15
16
17
810
11
11
No. Symbol Meaning
Off Battery is charged In charger / Out of charger
Flashes quickly Battery is charging In charger
Flashes slowly Low battery capacity,
charging necessary
11 Storage and charging unit for the remote control
1
“Dead man's principle” – the unit only moves only when the Dead man's switch and the func-
tion button (Move to position) are both pressed and held down.
Eleva Tube Head
Out of charger
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System Description System Components
1 Control Handle Display
2 Enable the rotation of the tube assembly round the stand axis.
3 Enable the angulation of the tube assembly round its transverse axis.
4 Enable the vertical movement of the tube assembly.
5 Control Handle Bar
6 Tape measure for measuring the SID
7 Central laser
8 Slider for covering the SID laser and the central laser
9 SID laser (optional)
10 Live camera (optional)
11 Collimator rails for filters and accessories.
12 Touch sensor to enable the following movements:
• Tube assembly longitudinally and
• Tube assembly transversely and
• Raise or lower the tube assembly
13 Knobs for setting the collimation field size
14 Collimator
15 Switch on the light field indicator and both lasers.
The lasers switch off automatically.
16 Enable the transverse movement of the tube assembly.
17 Enable the longitudinal movement of the tube assembly.
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System Components System Description
1 2
6
7
141618
22
17
3 4 5
8
9
10
11
12
13
15
19
20
21
Display of the Eleva Tube Head
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No. Description
1 Show or hide the patient data
2 Show or hide the list of examinations and associated views
3 Display the currently taken images of the selected patient
(The button is only active if there are current images of the patient available.)
4 Select the registration device
5 Select the patient type
6 Select the exposure settings
7 Test run for stitching (without radiation, only visible with the stitching license)
Stitching with table
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System Description System Components
No. Description
Stitching with wall stand
8 Settings for automatic exposure control
9 Select the target exposure index (EI_T)
10 Select an added filter
11 Select the focal spot
12 Switch tracking on or off
13 Alignment of the detector to the central X-ray beam
14 Enable or disable the collimation restriction (rights can be configured by the Advanced User only)
15 Collimation memory function
• Sets the collimator to the last value that was set manually.
• Sets the collimator to the value that is preset by the APR program.
16 Settings of the Eleva Tube Head display
• Brightness
• Test images (only for customer service)
17 Angulation of X-ray tube assembly (transverse axis)
18 SID (cm or in)
19 Radiation field size (cm × cm or in × in)
20 Grid status
21 Ready for exposure
When the icon is green, you can release exposures.
When the icon shows a red cross, you cannot release any exposures. Click the icon to display the sys-
tem messages.
22 In this area the following can be displayed:
• Scheduled examinations and views for the selected patient (shown in the example)
The drop-down list must be opened (position 2 in the image above).
• Preview image (on the entire screen, not shown in the example)
• Currently taken images of the selected patient (on the entire screen, not shown in the example)
The review button must be selected (position 3 in the image above).
• Image from the live camera (not shown in the example, only visible with license)
• Symbol for live camera on/off (not shown in the example, only visible with license):
Switch on the live camera
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System Components System Description
6
7
2 2
1 1
3 4
5
5
5
5
No. Description
Switch off the live camera
Problem with the live camera
Restart the system when this symbol appears. If restart is not successful, contact cus-
tomer service.
You can use the touch screen on the Eleva Tube Head with medical gloves.
NOTICE
Switching the preview image on or off
The preview image appears for 30 seconds at the Eleva Tube Head (default setting). You can switch off the preview image for the current patient in the Examination section of the Eleva Workspot (see the Instructions for Use Eleva Workspot).
Additionally, customer service or the application specialists can change the settings to one of the following:
• Different time interval for the preview image (5 seconds to 1 minute)
• Switch off the preview image permanently
Vertical Stand 2
These Instructions for Use describe the unit assuming operation from the left-hand side. A right-handed unit must be operated accordingly. A stretch grip is an available option, which can be fixed above the detector or wireless tray.
Components
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1 Column
2 Control panel (on both sides of the detector)
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System Description System Components
1
3
4
5
6
7
Memory
Tracking
Memory
3
2
4
8
6
5
3 Fixed detector with
• Collision guard
• Display of the position of the automatic exposure control measuring fields
• Chin rest
4 Wireless tray with
• Collision guard
• Display of the position of the automatic exposure control measuring fields
• Chin rest
5 Patient grips (right and left)
6 Remote control
7 Charging station for the remote control
Control Panel and Remote Control
Fig. 4: Control panel (on the left) and remote control (on the right)
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System Components System Description
Tracking
No. Symbol Meaning
1 Registration device selected
Select the registration device. Tracking is on. Press again to switch tracking off.
LED lit: tracking on.
2
Select the measuring field group.
The exposure measuring chamber has 5 measuring fields. With these buttons, you can select three of
them as shown on the buttons. Alternatively, you can select the measuring fields at the Eleva Workspot in
the generator area. The LEDs indicate which measuring fields are active.
•
The top edge of the front panel is defined by the chin rest.
• Orientation of the measuring fields to the top or bottom refers to the chin rest.
3
Switch on the light field indicator.
Open the radiation field transversely.
Close the radiation field transversely.
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Open the radiation field longitudinally.
Close the radiation field longitudinally.
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System Description System Components
No. Symbol Meaning
4 (only with tracking);
At the remote control:
Press once: The current status is displayed.
Press again: Switch between centered and off-center collimation.
At the control panel:
Press: Switch between centered and off-center collimation.
After a button is pressed, the LEDs on the remote control light up constantly.
Top off-center collimation (radiation field lies at top of detector field)
The top edge is fixed.
Centered collimation
The center is fixed.
Bottom off-center collimation (radiation field lies at bottom of detec-
tor field)
The bottom edge is fixed.
5 Raise the Bucky unit slowly (motorized)
Raise the Bucky unit quickly (motorized)
Lower the Bucky unit slowly (motorized)
Lower the Bucky unit quickly (motorized)
Move to position
1
1
1
1
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System Components System Description
No. Symbol Meaning
Bucky unit automatically moves into the top vertical position (example: chest position)
Bucky unit automatically moves upward to −20° (example: skull position)
Bucky unit automatically moves into the bottom vertical position (example: standing knee position)
Bucky unit automatically moves into the horizontal position (example: hand position)
Optional
6
Tilt the Bucky unit into the horizontal position (motorized)
1
Tilt the Bucky unit into the vertical position (motorized)
Bucky unit automatically moves into the horizontal position.
Detector not vertical: detector moves into the vertical position. The height remains the same.
Detector vertical: detector moves to −20°. The height remains the same.
7 Charging indicator
LED Battery status Remote control
Off Battery is charged Out of charger
Off Battery is charged In charger
Flashes quickly Battery charges In charger
Flashes slowly Low battery capacity,
1
Out of charger
charging necessary
8
Out of a lock: Manually move the detector up/down/longitudinal/lateral. Overriding collision is possible.
For your safety: If locked and a Chest PA view is selected, only up/down is possible.
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1
“Dead man's principle” – the unit moves only if a button is pressed and held down.
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System Description System Components
NOTICE
Simultaneous operation of two remote controls
If you simultaneously operate the remote control of the CSM and the remote control of the wall stand VS or VM, the movement will immediately stop. To continue, press any button on one of the remote controls.
Wall Stand with Fixed Detector
1
2
3 4
5
No. Description Function
1 Grid opening For inserting the grid
2 Flap of grid shelf For parking a grid
3 LED for grid status ON – grid correctly in place
OFF – no grid inserted
Flashing – grid carriage is moving or error (e.g. grid jam)
4 Button for loading/
unloading grid
5 Release lever (not
visible in this picture)
62 DigitalDiagnost C90 Version 1.1
Press to bring the grid carriage into load/unload position or back into working
position
Press to remove the grid from its carriage
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System Components System Description
1
2
3
4/5
6
Wall Stand with Wireless Tray
No. Description Function
1 Grid opening For inserting the grid
2 Tray grip For opening/closing the tray
3 LED for detector sta-
tus
ON – detector inserted correctly
OFF – no detector inserted
Flashing – detector inserted incorrectly
4 LED for grid status ON – grid inserted
OFF – no grid inserted
Flashing – grid carriage is moving or error (e.g. grid jam)
5 Button for loading/
unloading grid
Press here to bring the grid carriage into load/unload position or back into
working position
6 Release lever Press here to remove the grid from its carriage
Stretch Grip (Optional)
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System Description System Components
1
9
10 10
9
11
3
4
5
7
8
4
6
2
12
NOTICE
If the stretch grip is mounted, you can no longer tilt the detector and no motorized move­ments are possible.
DigitalDiagnost VM
64 DigitalDiagnost C90 Version 1.1
These Instructions for Use describe the unit with the operation of the detector from the right­hand side. A left-handed unit must be operated accordingly.
1 Ceiling rail
2 Position marker (in combination with DigitalDiagnost TH2 or single sided table TH-S)
3 Column
4 Control panel (on both sides of the detector)
5 Release/block the detector arm.
6 Grip with a switch to swivel the detector (on the rear, not visible in the figure)
7 Detector arm
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System Components System Description
Tracking
Memory
6
2
8
5
3
4
6
Memory
1
3
4
5
7
Tracking
8 Detector with
• Collision guard
• Chin rest.
9 Grips with switches to manually move the column
10 Patient grips
11 Floor rail
12 Electric motor for horizontal column movement
Control Panel and Remote Control
No. Symbol Meaning
1 Registration device selected
2 Switch on the light field indicator.
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“Dead man's principle” – the unit only moves only if a button is pressed and held down.
Select the registration device. Tracking is on. Press again to switch tracking off.
LED lit: tracking on.
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System Description System Components
Memory
No. Symbol Meaning
Open the radiation field transversely.
Close the radiation field transversely.
Open the radiation field longitudinally.
Close the radiation field longitudinally.
3 Select the measuring field group:
The exposure measuring chamber has 5 measuring fields. With these buttons, you can select three of
them as shown on the buttons. Alternatively, you can select the measuring fields at the Eleva Workspot in
the generator area. The LEDs indicate which measuring fields are active.
4
Collimator toggle function
• last value set manually
• automatic preset
Toggle between portrait and landscape format.
(only with tracking);
At the remote control:
Press once: The current status is displayed.
Press again: Switch between centered and off-center collimation.
At the control panel:
Press: Switch between centered and off-center collimation.
After a button is pressed, the LEDs on the remote control light up constantly.
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System Components System Description
No. Symbol Meaning
Top off-center collimation (radiation field lies at top of detector field)
The top edged is fixed.
Centered collimation
The center is fixed.
Bottom off-center collimation (radiation field lies at bottom of detec-
tor field)
The bottom edge is fixed.
5
Move the column to the right (motorized)
Raise the Bucky unit (motorized)
1
Move the column to the left (motorized)
Lower the Bucky unit (motorized)
1
1
1
Move to position
Bucky unit automatically moves into the top vertical position (example: chest position)
Bucky unit automatically moves behind table (example: horizontal beam, lateral spine position)
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System Description System Components
No. Symbol Meaning
Bucky unit automatically moves into the bottom horizontal position (example: hand)
Bucky unit automatically moves into the bottom horizontal position (example: abdomen on table)
Optional
6 Tilt the Bucky unit into the horizontal position (motorized)
1
Tilt the Bucky unit into the vertical position (motorized)
Bucky unit automatically moves into the horizontal position
Detector not vertical: detector moves into the vertical position. The height remains the same.
Detector vertical: detector moves to −20°. The height remains the same.
7 Charging indicator
LED Battery status Remote control
Off Battery is charged Out of charger
Off Battery is charged In charger
Flashes quickly Battery charges In charger
Flashes slowly Low battery capacity,
8
Out of a lock: Manually move the detector up/down/longitudinal/lateral. Overriding collision is possible.
For your safety: If locked and a Chest PA view is selected, only up/down is possible.
1
Out of charger
charging necessary
Out of a lock: Manually move the detector up/down/longitudinal/lateral.
Overriding collision is possible.
For your safety: If locked and a Chest PA view is selected, only up/down is possible.
1
“Dead man's principle” – the unit only moves only if a button is pressed and held down.
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System Components System Description
NOTICE
Simultaneous operation of two remote controls
If you simultaneously operate the remote control of the CSM and the remote control of the wall stand VS or VM, the movement will immediately stop. To continue, press any button on one of the remote controls.
Detector
1
2
3 4
5
No. Description Function
1 Grid opening For inserting the grid
2 Flap of grid shelf For parking a grid
3 LED for grid status ON – grid correctly in place
OFF – no grid inserted
Flashing – grid carriage is moving or error (for example, grid jam)
4 Button for loading/
unloading grid
5 Release lever (not
visible in this picture)
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Bring the grid carriage into load/unload position or back into working position
Press here to remove the grid from its carriage
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System Description System Components
Stretch Grip (Optional)
NOTICE
If the stretch grip is mounted, you can no longer tilt the detector and no motorized move­ments are possible.
DigitalDiagnost TH2
The DigitalDiagnost TH2 has a height-adjustable, floating table top.
Longitudinal and transverse movements of the table top are manual; upward and downward movements are motorized. The table has a Bucky unit, which can be moved longitudinally by hand. It is braked electrically.
You can order this table with the following functions:
• SID tracking (optional)
• Image receptor position tracking (optional)
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System Components System Description
1
6
2
5
3
4
87 9 7
Legend
1 Floating table top with rails for accessories
2 Disable the foot switches; the button is lit when the function is selected
3 Fixed detector (servo assist) or wireless detector (not shown)
4 Center indicator
5 Potential equalization terminal
6 Second table control (optional; can be installed anywhere on the rail, including the rear)
Left button Lower the table top (motorized)
Middle button • Enable the longitudinal and transverse movement of the
table top (floating table top)
• Turn on the light field indicator
Right button Raise the table top (motorized)
7 • Enable the longitudinal and transverse movement of the table top (floating table top)
• Turn on the light field indicator
8 Lower the table top (motorized)
9 Raise the table top (motorized)
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System Description System Components
Fixed Detector
1
3
42
5 6
No. Description Function
1 Grid opening For inserting the grid
2 Grid status ON – grid correctly in place
OFF – no grid inserted
Flashing – grid carriage is moving or error (e.g. grid jam)
3 Load/unload grid To bring the grid carriage into load/unload position or back
into working position
4 Release lever Press to the right for removing the grid from its carriage
5 Parking position for a grid For parking a grid
6 Detector plane indication For manual SID measurements
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System Components System Description
1 2 3 4 5/6 7
Wireless Detector
No. Description Function
1 Grid opening For inserting the grid
2 Tray grip For opening/closing the tray
3 Center indicator For aligning the the central X-ray beam to the detector.
4 LED for detector sta-
tus
5 LED for grid status ON – grid inserted correctly
6 Button for loading/
unloading grid
7 Release lever Press to remove the grid from its carriage
Single‐Sided Table TH‐S
ON – detector inserted correctly
OFF – no detector inserted
Flashing – detector inserted incorrectly
OFF – no grid inserted
Flashing – grid carriage is moving or error (e.g. grid jam)
Press to bring the grid carriage into load/unload position or back into working
position
This patient table is designed for usage with the wall stand VM.
The table top
• is supported on a single side, thus offering you easy access to the patient,
• is radiolucent, except in the area marked white,
• can be raised and lowered by motorized movement,
• can be moved manually in a horizontal direction (“floating table top”).
The table
• can be swiveled by 90° to allow X-ray tube assembly movement to the floor,
• has an potential equalization terminal.
You can disable the foot switches of the table.
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System Description System Components
6
1
3
4
5
7
2
8
2
1 Floating table top.
The white marking on the table top indicates the area that is not radiolucent. (In the image this
area is highlighted.)
2 Enable or disable the foot switches.
Enable movement in the event of a collision.
The buttons are lit when the foot switches are disabled.
The buttons flash in the following cases:
• The table top is swiveled.
• A collision has been detected.
3 Potential equalization terminal
A potential equalization terminal (earth) connection point is provided and located on TH-S. Use
this connection in areas, where it is required for meeting local safety standards. The IEC
60601-1 also gives guidance about a potential equalization terminal connection point. The com-
bination of the DigitalDiagnost and the equipment connected must comply with the require-
ments for medical electrical systems of IEC 60601-1.
4 Column
5 Enable the table swiveling.
6 Lower the table top (motorized).
7 Enable the longitudinal and transverse movement of the floating table top.
8 Raise the table top (motorized).
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System Components System Description
Fixed Detector
Description
5
6
7
8
9
Fig. 5: Fixed detector at a wall stand
Legend Description Function
1 Detector top Can be used as a patient’s chin rest
2 Active detector area This outlines the effective imaging area of the detector (43 cm × 43 cm [17 in ×
17 in]).
For radiation protection reasons the radiation field should never exceed this
area.
1 2
3
4
3 4 center marks For checking if the X-ray source assembly is correctly centered on the detector.
4 5 AMPLIMAT fields These are the sensitive areas for automatic exposure control, if used. Cham-
bers can be individually selected or deselected. Deselect any chambers that are
not covered by the radiation field or would receive direct radiation.
5 Grid status ON – grid correctly in place
OFF – no grid inserted
Flashing – grid carriage is moving, or grid error (for example, grid jam)
6 Load/unload grid Press to bring the grid carriage into load/unload position or back into working
position
7 Detector plane indi-
cation
8 Grid opening with
metal flap
9 Release lever Press to remove the grid from its carriage
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For manual SID measurements
For insertion of the grid
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System Description System Components
1
5 6
Fig. 6: Fixed detector below the table
No. Description Function
1 Grid opening For insertion of the grid
2 Grid status ON – grid correctly in place
3 Load/unload grid Press to bring the grid carriage into load/unload position or
4 Release lever Press to the right to remove the grid from its carriage
3
OFF – no grid inserted
Flashing – grid carriage is moving, or grid error (for example,
grid jam)
back into working position
42
5 Parking position for a grid For parking a grid
6 Detector plane indication For manual SID measurements
The fixed detector is equipped with 5 AMPLIMAT ionization chambers for automatic exposure control (AEC), with a Bucky grid holder and exchangeable anti-scatter grids.
SkyPlate Detector
Overview
Fig. 7: SkyPlate detector small and large, SkyPlate E detector and battery charger (from left to right)
The SkyPlate is a cassette-sized wireless portable detector and comes with a battery charger.
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System Components System Description
SkyPlate
2
3
1
100kg/220lbs
9
4
5
6
7
8
100kg/220lbs
SkyPlate
SkyPlate
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Fig. 8: Front view 35 cm × 43 cm (14 in × 17 in) format and 24 cm × 30 cm (10 in × 12 in) format
No. Description Function
1 Corner marking This indicates the top left of the detector.
2 Sensitive area This delineates the effective imaging area of the detector. For radiation protec-
3 Center marks For checking if the X-ray tube assembly is correctly centered on the detector.
4 LED
tion purposes, the radiation field should never exceed this area.
Detector status
SkyPlate
Detector status
SkyPlate E
green = ready for exposure
flashing green = sleep mode
red = not ready for exposure
green = ready for exposure
flashing green = sleep mode
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System Description System Components
No. Description Function
red = not ready for exposure
no light = switched off
flashing red = error state
flashing rapidly red = switching on
5 Connector For connecting the backup cable. The backup cable delivers data to the Eleva
Workspot.
6 LED WiFi status
(connection for data
transfer to the work-
station)
SkyPlate and
SkyPlate E
7 Switch on/off
SkyPlate
To switch off the detector, press the button for 5 seconds. After 5 seconds, the
LED of the detector status changes to flashing red. Release the button. All LEDs
turn off.
Switch off the detector before removing the battery. The detector switches on
automatically as soon as the battery is inserted.
If the image has not yet been transferred to the Eleva Workspot, you cannot
switch off the detector.
Switch on/off
SkyPlate E
To switch on the detector, insert the battery.
To switch off the detector, remove the battery.
The SkyPlate E does not have the ON/OFF button
8 LED
Battery status
SkyPlate and
SkyPlate E
green = WiFi connection ready (detector con-
nected to an access point)
red = WiFi connection not ready (detector not
connected to an access point)
no light = WiFi off
green = OK
red = power low
flashing red = not enough power to create an
image
no light = no battery or detector is switching
on
9 Infrared sensor For connecting the detector to the system.
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System Components System Description
1 1
NOTICE
• The SkyPlate changes to sleep mode in the following cases:
− You are in the Patient list section.
− The SkyPlate is not selected as a registration device.
− The SkyPlate is not attached.
− The system is shut down.
− The SkyPlate is out of the WiFi range. Then the SkyPlate enters the sleep mode within 1 minute.
• When you move the detector (applicable only to Skyplate E) or when you change to the Examination section, the detector is ready for exposure again. The LED of the detector sta­tus changes to green.
• When you switch off the system or detach the SkyPlate, the SkyPlate switches off automat­ically after 20 minutes.
Fig. 9: Rear view 35 cm × 43 cm (14 in × 17 in) format and 24 cm × 30 cm (10 in × 12 in) format
No. Description
1 Battery
Switching the SkyPlate E Detector On and Off
To switch off the SkyPlate E detector, remove the battery (see chapter “Changing the Batteries”
190
on page
).
To switch on the detector, insert the charged battery (see chapter “Changing the Batteries” on page 190).
The SkyPlate E detector does not have the switch off button.
•
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System Description System Components
• The detector goes into standby state when the Eleva Workspot is not in the Examination section. The LED on the detector starts blinking green.
• The detector stays in standby state for another 30 minutes and then switches off.
• To switch on the detector, either tap or move the detector.
NOTICE
The SkyPlate E detector does not have the switch off button. It switches off when the battery is removed or by complete discharge of battery or after 30 minutes of standby.
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System Components System Description
3
4
5 5
6
7 7
1 2
9
8
Detector Tray
At the Patient Table
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No. Meaning
1
Green detector indicator lamp:
LED Bucky unit detector status
Off No detector inserted
On Detector inserted correctly
Blinking Detector not inserted correctly
2
Yellow grid indicator lamp:
3 Guiding bar for positioning and clamping the detector
LED Bucky unit grid status
Off No grid inserted
On Grid inserted correctly
Blinking Grid jam
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System Description System Components
No. Meaning
4 Centering lines for correct positioning
5 Pins for size sensing and holding the detector in place
6 Opening for grasping the detector
7 Clamping tabs
8 Lever for opening and closing the Bucky tray
9 Mark for centering the tube assembly to the detector
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System Components System Description
1
2
3
4
5
5
6
7
7
8
9
At the Wall Stand
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No. Meaning
1
Green detector indicator lamp:
LED Bucky unit detector status
Off No detector inserted
On Detector inserted correctly
Blinking Detector not inserted correctly
2
Yellow grid indicator lamp:
LED Bucky unit grid status
Off No grid inserted
On Grid inserted correctly
Blinking Grid jam
3 Guiding bar for positioning and clamping the detector
4 Centering lines for correct positioning
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System Description System Components
1
2
3
5
4
No. Meaning
5 Pins for size sensing and holding the detector in place
6 Opening for grasping the detector
7 Clamping tabs
8 Lever for opening and closing the Bucky tray
9 Mark for centering the tube assembly to the detector
Battery Charger
No. Description
1 Battery slot
2 Connector to battery
3 Power supply connection and LED
4 Mark for alignment with battery
5 Status LED
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System Components System Description
NOTICE
Do not place the battery charger within the patient environment.
Do not touch the battery connector pins.
Symbol
LED Orange Flashing green Flashing green Flashing green Flashing green Green
Charging level Error signal 0%–25% 25%–50% 50%–75% 75%–100% 100%
Charging Status
Error Types
LED What it indicates What to do
Orange status LED lights up The battery has not been inserted cor-
rectly into the charger.
The battery has overheated. Remove the battery and reinsert after it
No green power LED No power from power supply. Check that the power supply is on.
No LEDs light up The battery has not been inserted cor-
rectly into the charger.
Remove battery and reinsert. If the prob-
lem remains, the battery might be defec-
tive.
has cooled down.
Remove the battery and reinsert. If the
problem remains, check whether the
connectors are damaged or the battery is
defective.
Storing the Grids and Detectors
WARNING
Risk of damage
Use the detector and grid storage only for storing detectors and grids. Do not lean on the detector and grid storage.
CAUTION
Do not place unused detectors next to the infrared adapter.
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System Description System Components
Fig. 10: Detector and grid storage
You can store either a grid, a detector, or a grid with installed detector. There are two slots for storing.
PCR S Plus Cassette Reader
10
13
12
2
3
11
4
1
6
5 7
9
8
The cassette reader reads out the exposed imaging plates. The imaging plates are contained in the cassettes.
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System Components System Description
No. Meaning
1 Monitor (see below)
2 Buttons for selecting mode
With these buttons, you can select the modes assigned on screen.
3 Pilot lamp
Lights up green when the main switch is in position “I” (on).
4 Sleep mode indicator
If the light is flashing, the monitor is in sleep mode (i.e. saving energy).
5 Ready indicator
If it is lit (green), the plate reader is ready for operation.
6 Status display for cassette processing
Lights up (green): the cassette was inserted correctly.
Flashes (green): processing complete.
Unlit: the imaging plate is in the cassette again.
7 Unload lamp
Flashes blue when the cassette can be removed. After the cassette has been removed, the lamp goes
out.
8 Message indicator
When it lights up (yellow), a window with special instructions appears on the monitor of the operator’s
console. You should follow these instructions. When an error message appears, an audible warning sig-
nal is given additionally.
9 Power switch
Switches on the plate reader if the main switch is in position “I” (on).
10 Cassette compartment with dust filter
For exposure of a cassette with an imaging plate.
11 Main switch
Is always left in position “I” (on). Switching off is only advisable for prolonged stoppages.
12 Mains connection
13 Socket for connecting external devices.
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System Description System Components
2
3
4
5
6
1
Start Screen
No. Meaning
1 Text box
The name of the selected menu appears here.
2 Field for system messages
3 - User instructions
- Status display
4 Progress indicator
It displays the status of cassette processing (see below).
5 Function data annotation
6 Network connection status
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System Components System Description
Progress Indicator
No cassette inserted
Cassette inserted, starting readout
Image plate readout
Deleting
Deleting finished
Readout finished, removing cassette
lights
lights
lights
lights
flashes
flashes
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System Description System Components
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Switching On Switching the System On/Off

Switching the System On/Off

4

Switching On

NOTICE
To ensure a proper startup of the system do not touch and do not move any components dur­ing the startup. Otherwise, the components may not start up properly and you may have to restart the system.
The startup is finished when the system shows the following:
• The Eleva Workspot displays the patient list.
• The display of the Eleva Tube Head displays the lock screen.
Philips recommends the following sequence:
► Press this monitor button for approx. 1 second.
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⇨ The Eleva Workspot and all other components switch on.
► Log on to the decryption screen.
• Enter the user name.
• Enter the password.
Page 96
Switching the System On/Off Logging In
NOTICE
For systems without disk decryption
If your system is not decrypted, you will get the login screen instead of the decryption screen. The login screen is described in the following sections.

Logging In

► Log in to the program.
• Enter the user name.
• Enter the password.
NOTICE
The default user name is “user”, the default password is “user”. The administrator and cus­tomer service can change the user accounts.
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Quick Logout Switching the System On/Off
DigitalDiagnost C90
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Quick Logout

You can log out at any time.
► Click there.
⇨ The log-on screen appears.
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Page 98
Switching the System On/Off Switching Off

Switching Off

NOTICE
The Eleva Workspot is designed for continuous operation. Therefore, it is necessary to switch off all components only in the event of prolonged stoppages.
NOTICE
It is recommended to restart the Eleva Workspot and all other components once a week.
► Press this monitor button to switch off the Eleva Workspot and all other components
NOTICE
It can take several seconds for the system to shut down.
NOTICE
Do not keep the button pressed.
If you keep the button pressed for more than 4 seconds, the system is aborted. This might harm the system.

Aborting the System

⊳ The system is not responding and cannot be shut down properly
► Press this monitor button for approx. 4 s.
⇨ The Eleva Workspot and all other components shut down.
.
.
NOTICE
Abort the system only if necessary. It might harm the system.
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Restarting the System Switching the System On/Off

Restarting the System

► Press this for 4 s.
⇨ The Eleva Workspot is restarted. All other components are not effected by the restart.

Emergency Access to the System

NOTICE
Unless the disk encryption has been specifically disabled, the disk encryption is enabled by de­fault. On systems where the disk encryption is active, the emergency access is available only when the encrypted disk is unlocked. You need to unlock the disk at each system startup (decryption login). The disk remains un­locked until shutdown and reboot. Without entering the decryption password, not only access to the encrypted data is restricted, but the system cannot be used in its entirety. If the system needs to operate in an emergency mode without decryption password, disk en­cryption needs to be disabled, even though not recommended for security and privacy rea­sons. When you have decided to disable disk encryption, this can be only reverted through a new system installation by the customer service.
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NOTICE
Define an emergency access process in case the emergency's login is not available, because the encrypted disk is locked at system startup and an initial authentication is required to get the system operable.
The emergency mode permits access to the system without a user name and password. When you use the emergency access to the system, the system enforces restrictions to prevent access to all other (non-emergency) patient data.
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Switching the System On/Off Emergency Access to the System
DigitalDiagnost C90
In the Emergency mode the following applies:
• Only the “Emergency” worklist is available; it contains only patient data with an emergency status.
The picture shows a patient with emergency status (symbol in the left column).
• All patients added here are given emergency status.
• You cannot access other patients (for example from RIS).
• RIS query is not possible.
To cancel the emergency status of the patient data:
► Log in as a registered user.
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