Varex Imaging Deutschland XRPAD2 Users manual

XRpad2 4336 Digital X-ray Detector System User Manual

DIGITAL IMAGING

Before using the X-ray detector, be sure to read this manual thoroughly along with any other manuals for the software and other system components. Keep this manual where it is easily accessible.

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Before You Begin XRpad2 4336

Before You Begin

• To avoid personal injury or product damage, read the manual and all accompanying

information carefully before installing and using the X-ray detector.

• The X-ray detector is intended for use by trained and qualified professional personnel who

are knowledgeable with the use of X-ray detectors, X-ray systems, and electrical equipment.

• The user is responsible for using and maintaining the detector according to prescribed

installation, usage, maintenance, handling, and storage specifications. To keep the detector and its accessories in a safe and proper condition, only trained and qualified professional person(s) shall be in charge of maintenance.

• X-ray imaging, image processing, image acquisition, and data storage must be performed in

accordance with the applicable laws. The user is also responsible for compliance to laws pertaining to the privacy of image data.

• In no event is X-ray detector manufacturer liable for direct, indirect, or consequential injury,

damage, or loss of equipment operation time or image data arising from the use of the X-ray detector, its components, and/or accessories.

Protection Against Ionizing Radiation

DIGITAL IMAGING

• Exposure of any part of the human body to X-radiation may be harmful to health. Whenever

• The X-ray detector is intended to be installed, maintained, and used by qualified professional

• The X-ray detector does not contain a primary barrier for X-rays or Gamma rays. The X-ray

• For portable applications, the X-ray system installer or X-ray system manufacturer must

X-ray equipment or radioactive sources are in use, appropriate safety precautions and measures shall be instituted, and all regulatory requirements must be met. It is the responsibility of the X-ray system installer, operator, and user to comply with applicable requirements.

personnel who are trained and qualified in the installation, maintenance, and use of X-ray equipment.

system installer or X-ray system manufacturer must provide the necessary protection based on the X-ray system’s intended use.

provide the necessary training for operators to protect themselves, patients, and surrounding persons.

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XRpad2 4336 For Your Safety

For Your Safety

To avoid personal injury or product damage, read this manual and all accompanying information carefully before handling, installing, or using the X-ray detector. Follow all instructions, warnings, and cautions in this manual and all warnings and cautions printed on the warning label. Ignoring instructions, warnings, or cautions in the handling, installing, or using of the detector may result in personal injury, death, or product damage. Keep this manual for future reference.

Meaning of Alerts and Notes

DIGITAL IMAGING

DANGER

WARNING

Caution

Note

This indicates a potentially hazardous situation which, if ignored, will result in severe personal injury, death, or substantial product damage.

This indicates a potentially hazardous situation which, if ignored, may result in severe personal injury, death, or substantial product damage.

This indicates a potential hazardous situation which, if ignored, may result in minor or moderate personal injury or damage to the product.

This emphasizes or supplements important information about the main text.

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For Your Safety XRpad2 4336

Installation and Environment of Use

DIGITAL IMAGING

WARNING

Caution

Do not operate the X-ray detector in or around flammable gases, gas mixtures, liquids, chemicals, or other substances. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.

Do not operate the X-ray detector in a location with the following conditions.

Close to fluid or places where fluid is used

•

• Close to heat sources, such as a heater

• High temperature environment

• High humidity environment

• High condensation environment

• Extreme cold environment

• Dusty environment

• Salty or sulphurous environment

• Near a vibrating environment

Ignoring this caution may result in personal injury or damage to the product.

WARNING

Do not connect the X-ray detector to any component or accessory other than the manufacturer’s specified components and accessories. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.

Do not modify or alter the X-ray detector, its components, or accessories. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.

The detector is not designed to control X-ray dose. The system integrator is responsible for controlling the X-ray radiation.

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XRpad2 4336 For Your Safety

Interface and Power Unit and Cables

DIGITAL IMAGING

WARNING

Be sure to turn OFF the power of the X-ray detector, including turning off the power supply or removing the battery (if applicable) before servicing, maintaining, connecting, or disconnecting the cables or accessories.

Do not touch the power supply, Lithium Battery Pack, X-ray detector, cable, connector, or any other electrical component or equipment with wet hands. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage.

Disconnect the cables by pulling on the connector and not the cable itself. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage.

Do not modify the cables or subject the cable to external stress or damage. Avoid placing anything heavy, including the detector, on the cable, stepping on the cable, pulling the cable, or subjecting the cable to excessive bending or bundling. Ignoring this warning may cause cable failure resulting in electrical shock, which may result in severe personal injury, death, or substantial product damage.

WARNING

Do not turn ON the power supply or X-ray detector when condensation is on the X-ray detector or any of its components or accessories. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage.

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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For Your Safety XRpad2 4336

Handling

DIGITAL IMAGING

WARNING

Caution

Never disassemble, modify, or alter the X-ray detector, its components, Lithium Battery Pack battery, battery charger, or accessories. Ignoring this warning may cause electrical shock and/or unknown hazards, which may result in severe personal injury, death, or substantial product damage.

Do not touch the interface and power unit or cable and the patient at the same time. Do not let the patient touch the interface and power unit or cable. Ignoring this warning may cause electrical shock and/or unknown hazards, which may result in severe personal injury, death, or substantial product damage.

Place the X-ray detector horizontally on a flat, stable surface. If the X-ray detector is placed vertically or in any tilted position, the X-ray detector must be securely placed in the Bucky tray or securely fastened to the X-ray detector enclosure or support structure. Ignoring this caution may result in personal injury or damage to the product.

Do not exceed the maximum uniform load weight of 150 kg distributed across the surface of the X-ray detector.

Caution

Do not exceed the maximum load weight of 100 kg distributed on an area of 40 mm in a diameter of the X-ray detector surface.

Do not drop the X-ray detector. If the X-ray detector is dropped, remove the X-ray detector from service, and immediately ask your establishment’s safety representative to verify or re-validate the proper function of the X-ray detector prior to resuming use of the detector. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.

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XRpad2 4336 For Your Safety

Battery

DIGITAL IMAGING

WARNING

Do not use the XRpad2 LBP (battery) if the casing is broken or if it emits an unusual odor, smoke, or excessive heat, or if it leaks any substance. Avoid contact with any substance seeping from the battery pack. If any fluid touches your skin or eyes, wash the affected area with clean, running water and immediately seek medical attention.

The cells within the battery contain toxic substances. Do not attempt to open the battery. Do not insert any object into the battery pack or use any device to pry at the battery pack casing. Attempting to open the battery casing will damage the casing, which could cause the battery to release toxic and harmful substances causing injuries such as electric shock or burns, or cause a fire, and will render the pack unusable.

Observe and follow all safety information in this manual and on the warning label found on the battery. Ignoring a warning may result in personal injury or damage to the product.

Use only charging devices approved by device manufacturer, and never attempt to bypass or override their charging protection circuits.

WARNING

Keep out of reach of children.

Remove the battery if the X-ray detector is not likely to be used for some time.

Do not submerge the battery in water or other liquid.

Do not charge the battery near flammable materials.

Do not connect the battery to an electrical outlet directly, or to any other electrical source not described in the manual.

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For Your Safety XRpad2 4336

WLAN

DIGITAL IMAGING

WARNING

Caution

WARNING

Do not drop or hit the battery against hard objects since this may cause damage to the battery and risk release of the battery toxic and harmful substances, causing injuries such as electric shock or burns or causing a fire, and will render the battery unusable.

Do not use the battery charger in the patient environment.

There is a risk of explosion, personal injury, or damage to product if the battery is replaced by non-OEM approved components.

Do not obstruct the detector antenna. If it is obstructed by metal, wood, or a human body, the wireless communication can be slowed down or disconnected.

Follow the laws and regulations for each country, and select the regional code accordingly.

WARNING

Caution

WARNING

Do not use the detector in aircraft because there is a potential affect to aviation systems.

Use WLAN access point devices to get the best communication performance.

The electromagnetic emission of the detector may influence implantable medical devices like pacemakers. Check the information for these devices.

Do not modify or alter the detector as this can violate the certification of the Radio Law.

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XRpad2 4336 For Your Safety

Automatic Exposure Detection (AED) Mode

DIGITAL IMAGING

WARNING

The AED mode requires a sufficient X-ray dose rate to the detector surface. The required dose rate can vary between X-Ray tube, generator, and X-ray voltage. The system integrator must evaluate the AED operation with the complete X-ray setup in order to secure a proper image acquisition in AED mode.

The external sync mode is the default acquisition mode, and the detector needs to switch into the AED mode to use the Auto Exposure detection. It is important that a settling time for the AED is implemented by the system integrator. If the settling time is too short, the image can show artifacts.

The AED on-time is limited and must be turned off directly after acquiring the image. Staying longer in AED mode will reduce the battery duty cycle and heat up the detector.

Do not apply any, handling, loading, mechanical shock, or electronic noise to the detector while it is in AED mode. These actions can start an unwanted acquisition (false trigger). If a false trigger is applied to the detector, the detector will not be able to react on a real X-ray exposure until it has acquired the false trigger image.

If a Problem Occurs

WARNING

If any abnormal condition, such as smoke, fumes, or strange sounds, is evident, turn off the X-ray detector, turn off and unplug the power supply from the AC outlet, and immediately ask your establishment’s safety representative to contact your dealer, distributor, or device manufacturer.

Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.

When liquid has been spilled into or on any part of the X-ray detector or power supply (if applicable), or when the X-ray detector, its component, or accessory is dropped, unplug the power supply from the AC outlet, and immediately ask your establishment’s safety representative to contact your dealer, distributor, or device manufacturer.

Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.

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For Your Safety XRpad2 4336

Maintenance and Inspection

DIGITAL IMAGING

WARNING

Caution

Turn off the power of the X-ray detector when the inspections indicated in this manual are going to be performed. Ignoring this warning may result in electric shock, which may result in severe personal injury, death, or substantial product damage.

When the X-ray detector system is going to be cleaned, turn off the X-ray detector and remove the battery. If the X-ray detector is connected to a power supply, turn off the power switch and/or unplug the power supply cable from the AC outlet. If the X-ray detector is battery powered, remove the battery. Never use thinner, benzine, acetone, or other flammable cleaning agents. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.

The X-ray detector must be repaired by X-ray detector manufacturerauthorized personnel only. Ignoring this warning may result in explosion, fire, electric shock, or unknown hazards, which may result in severe personal injury, death, or substantial product damage.

Follow the manufacturer’s recommendations for inspecting the X-ray detector before use.

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1.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2.0 Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3.0 Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4.0 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

5.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

6.0 Definition of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

7.0 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

8.0 Description of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8.1 Overview of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8.2 Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

8.3 X-ray Detector Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

8.4 X-ray Detector Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

8.5 X-ray Detector Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

8.5.1 Rechargeable Lithium Battery Pack (XRpad2 LBP) . . . . . . . . . . . . . . . . . 13

8.5.2 XRpad IPU-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

8.6 Minimum System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

8.7 Operating the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

8.7.1 Wired X-ray Detector Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

8.7.2 Wireless X-ray Detector Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

8.7.3 Before Using the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

8.7.4 Powering On the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

8.7.5 Powering Off the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

8.7.6 General Workflow for Acquiring an Image. . . . . . . . . . . . . . . . . . . . . . . . 27

DIGITAL IMAGING

9.0 Inspection and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.1 Daily Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.1.1 Before Turning On the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

9.1.2 After Turning On the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

9.1.3 After Turning Off the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

9.2 Monthly Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

9.3 Yearly Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

9.4 Calibrating the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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Table of Contents XRpad2 4336

9.5 Cleaning the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

9.6 Error Messages and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

10.0 After-Sales Service for PerkinElmer Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

11.0 Disposing of the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

12.0 Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

12.1 Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

12.2 Declaration of Conformity for European Union (and EEA). . . . . . . . . . . . . . . . . . 40

12.3 Federal Communication Commission Interference Statement (US) . . . . . . . . . . . 42

12.4 Industry Canada Statement (English) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

12.5 Industrie Canada – Déclaration (Français) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

12.6 Korean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

DIGITAL IMAGING

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List of Figures

Figure 1 X-ray Detector (Front View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Figure 2 Dimensions for the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Figure 3 Patient Vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Figure 4 XRpad2 LBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Figure 5 Removing the XRpad2 LBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Figure 6 XRpad IPU-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Figure 7 Wired Connection of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Figure 8 Wireless Connection of the X-ray Detector (Station/Client Mode) . . . . . . . . . . . . 24

Figure 9 Wireless Connection of the X-ray Detector (WAP Mode) . . . . . . . . . . . . . . . . . . . . 25

DIGITAL IMAGING

Figure 10 Workflow for Acquiring an Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

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List of Tables

Table 1 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Table 2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Table 3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Table 4 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Table 5 Overview of the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Table 6 Environmental Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Table 7 X-ray Detector Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Table 8 Accessories for the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Table 9 Specification of the XRpad2 LBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Table 10 Overview of the XRpad IPU-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

DIGITAL IMAGING

Table 11 Specification of the XRpad IPU-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions . . . . . . 36

Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity . . . . . . 37

Table 14 Recommended Separation Distance between Portable and Mobile

RF-Communication Equipment and the X-ray Detector . . . . . . . . . . . . . . . . . . . . . 38

Table 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity

(Portable Equipment). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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1.0 Scope

This document describes design elements and respective interfaces for the XRpad2 4336 detector. Applicable mechanical, electronic, and software interfaces are addressed. PerkinElmer digital X-ray Flat Panel Detectors and their accessories are components designed to be integrated into products by X-ray system manufacturers. Manufacturers are responsible for qualifying, validating, and certifying their products for their intended uses and meeting all applicable regulatory requirements.

Final application and intended use is based on the completed X-ray system design. It is the responsibility of the X-ray system manufacturer to confirm the efficacy and compliance of the X-ray system for its intended use, inclusive of the detector. The Digital Radiography Software referred to in this manual is medical imaging software for radiography, which is typically supplied by the X-ray system manufacturer or third-party provider and is not part of the XRpad2 4336 detector.

2.0 Usage

The XRpad2 4336 detector is a component of a digital imaging system used for generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional Screen-Film (SF), Digital Radiography (DR), or Computed Radiography (CR) systems may be used.

DIGITAL IMAGING

3.0 Audience

This document is for users of the X-ray detector and for X-ray system manufacturers and X-ray system installers who are responsible for installing the X-ray detector into an X-ray system.

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4.0 Abbreviations

Table 1 includes a list of abbreviations used in this manual and a description of each

abbreviation.

Table 1 Abbreviations

Abbreviation Description

AED Automatic Exposure Detection

AP Access Point

CR Computed Radiography

DFS Dynamic Frequency Selection

DR Digital Radiography

ESS Extended Service Set

FoV Field of View

fps Frames per second

XRpad2 4336

GigE Gigabit Ethernet

DIGITAL IMAGING

I/F Interface

IP Internet Protocol

IPU Interface and Power Unit

LAN Local Area Network

LBC Lithium Battery Charger

LBP Lithium Battery Pack

LED Light Emitting Diode

MDD Medical Device Directive

OEM Original Equipment Manufacturer

REF Radiated Electromagnetic Field

Rx Caution: Federal law restricts this device to sale by or on the order of a licensed

SELV

SF Screen Film

WAP Wireless Access Point

healthcare practitioner

Separated or Safety Extra-Low Voltage

WEEE Waste Electrical and Electronic Equipment

Wi-Fi Wireless Fidelity

WLAN Wireless Local Area Network

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XRpad2 4336

5.0 References

Table 2 includes a list of documents referred to in this manual. For access to the following

references, contact your establishment’s representative or your dealer, distributor, or device manufacturer.

Table 2 References

Document Name Document #

DIGITAL IMAGING

1 XRpad LBC Charger for Rechargeable Lithium-Ion

Battery Pack

2 XRpad LBP Rechargeable Lithium-Ion Battery

Pack

3 XRpad2 4336 Digital X-ray Detector System

Reference Manual

4 Digital Radiography Software Manual

5 Digital Radiography Software

6 Access Point Manual Supplied by the Access Point Manufacturer or

48773

48772

69652

Supplied by

third-party provider

Supplied by

third-party provider

X-ray system manufacturer or

6.0 Definition of Symbols

Table 3 includes a list of symbols and a description of each symbol.

Table 3 Symbols

Symbol Description

This Way Up.

Handle with Care.

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Keep Dry.

Reusable.

Disposal (WEEE). Follow all local and regional disposal requirements.

Refer to instruction manual/booklet.

Manufacturer‘s name and address.

Date of Manufacture, YYYY-MM, YYYY=Year, MM=Month.

REF = Reference Number. PerkinElmer Catalog Number, Part Number, or Material Number.

Table 3 Symbols (Continued)

Symbol Description

XRpad2 4336

~AC Input.



DIGITAL IMAGING

Serial Number.

D.C. Voltage.

Temperature Limitation.

Relative Humidity Limitation.

Potential Equalization.

Functional Earth Connection.

Protection Class I.

Protection Class II.

Non-Ionizing Radiation.

Battery charge condition.

• Battery Charged (> 75%).

• Battery ¾ (≤ 75%).

• Battery Half (≤ 50%).

• Battery Low (≤ 25%).

• Battery Empty (≤ 10%).

• No Battery.

Wireless Connectivity/No Wireless Connectivity.

LAN Connection/Missing LAN Connection.

Access Point

Trigger Connection.

Push Button.

Power Switch.

Do not crush.

Do not expose to fire.

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XRpad2 4336

Table 3 Symbols (Continued)

Symbol Description

Keep away from children.

Maximum Load.

UL Recognized component mark for US and Canada.

DIGITAL IMAGING

European Conformity markings for the product.

7.0 Standards and Regulations

The X-ray detector is designed to be compliant with the standards and/or regulations detailed in

Table 4. The manufacturer’s certifications to standards and regulations are valid only if the

original accessories (as listed in Table 8) are used according to prescribed instructions. Product certification and warranty are rendered void if any modification or alteration to the product is made, or any instruction, warning, or caution is not followed.

Table 4 Standards and Regulations

Standards and Regulations Description

ANSI/AAMI Std ES60601-1:2005 Medical electrical equipment Part 1: General Requirements for

Basic Safety and Essential Performance

EN IEC 60601-1:2006/AC:2010 General Requirements for Basic Safety for Medical Electrical

Equipment

EN IEC 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General Requirements for

Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility

CAN CSA C22.2 No 60601-1 08 Medical Electrical Equipment Part 1: General Requirements for

Basic Safety and Essential Performance

FCC Part 15 subpart B/E Radio Frequency Exposure

ETSI EN 301 893 V.1.7.1 (2012) Broadband Radio Access Networks (BRAN); 5 GHz high

performance RLAN

ETSI EN 301 489-1 V1.9.2 (2011) Electromagnetic Compatibility and Radio spectrum Matters

(ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements

ETSI EN 301 489-17 V2.2.1 (2012) Electromagnetic Compatibility and Radio spectrum Matters

(ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for 2.4 GHz wideband transmission systems and 5 GHz high performance RLAN equipment”

EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for

in vitro cytotoxicity

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