Varex Imaging Deutschland XRPAD4336 Users manual

PUB

XRPAD

4336

MED

- USER MANUAL

TBA

Document Title Document No.

This document is confidential and proprietary to PerkinElmer

The following pages contain the “User Manual”

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REVISION

1 Initial release S. Arnold TBA 2013-11-29

SECTIONS CHANGED

ORIGINATOR CN DATE

TBA, Ver.01 PUB XRpad 4336 MED User Manual

Printed document is valid for use within the day printed.

Use or verify the latest revision of document in Document Control

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XRpad™ 4336 MED

Before using the detector, be sure to read this manual thoroughly along with any other

Digital X-Ray Detector System

DI GIT AL IM AG I N G

U S E R M A N U A L

manuals for the software and other system components. Keep this manual where it is easily accessible.

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PLEASE NOTE

To avoid personal injury or product damage, read the manual and all accompanying information carefully before installation or use of the XRpad™ 4336 MED detector. The 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 PerkinElmer 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

U S E R M A N U A L

Exposure of any part of the human body to x-radiation may be harmful to health. Whenever 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. The x-ray detector is intended to be installed, maintained, and used by qualified professional personnel who are trained and qualified in the installation, maintenance, and use of x-ray equipment.

The x-ray detector does not contain a primary barrier for x-rays or Gamma rays. The x-ray system installer or manufacturer must provide the necessary protection based on the x-ray system’s intended use. For portable applications the x-ray system installer or manufacturer must provide the necessary training for the operator to protect them self, the patient, or surrounding persons.

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FOR YOUR SAFETY

To avoid personal injury or product damage, read this manual and all accompanying information carefully before handling, installing, or using the XRpad™ 4336 MED 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 Caution Signs

U S E R M A N U A L

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.

Installation and Environmental Use

Do not operate the x-ray detector in or around flammable gases, gas mixtures,

WARNING

Caution

WARNING

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. Do not connect the x-ray detector to any component or accessory, other than

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.

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Interface and Power Unit and Cables

Be sure to turn OFF the power of the XRpad™ 4336 MED detector, including turning off the power supply and or removal of the XRpad™ LBP (Lithium

WARNING

Battery Pack) before servicing, maintaining, connecting, or disconnecting the cables or accessories. Do not touch the power supply, Lithium Battery Pack, 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.

Do not turn ON the power supply or x-ray detector when condensation is formed on the system. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage.

U S E R M A N U A L

Handling

WARNING

Caution

Never disassemble, modify, or alter the x-ray detector, its components, Lithium Battery Pack, 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 detector is placed vertically or in any tilted position, the detector must be securely placed in the Bucky tray. Ignoring this caution may result in personal injury or damage to the product.

Do not exceed the maximum load weight of 150 kg distributed around the overall surface of the detector (Uniform Load).

Do not exceed the maximum load weight of 100 kg distributed on an area of 40 mm in a diameter of the detector surface (Local Load).

Do not drop the detector. If the detector is dropped, remove the detector from service and inform your establishment safety representative immediately to verify or re-validate the proper function of the 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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Battery

WARNING

Do not use the XRpad™ LBP (Lithium Battery Pack) 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 XRpad™ LBP contain toxic substances. Do not attempt to open the battery packs. Do not insert any object into the battery pack or use any device to pry at the battery pack casing. Attempting to open the XRpad™ LBP casing will damage the casing which could cause the LBP to release toxic and harmful substances, causing injuries such as electric shock, 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 XRpad™ LBP. Ignoring warning may result in personal injury or damage to the product.

U S E R M A N U A L

WARNING

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

Keep out of reach of children.

Remove the XRpad™ LBP if the XRpad™ 4336 MED detector is not likely to be used for some time.

Do not submerge the XRpad™ LBP in water or other liquid.

Do not charge the XRpad™ LBP near flammable materials

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

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

Do not use the Battery Charger in the patient environment

Caution

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Risk of explosion, personal injury, or damage to product if the Battery

XRpad™ LBP is replaced by non-OEM approved component.

When a Problem Occurs

If any abnormal condition is evident such as smoke, fumes, or strange sounds, unplug the power supply from the AC outlet, and inform your establishment

WARNING

safety representative immediately to contact your dealer, distributor, or PerkinElmer. 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, power supply, Lithium Battery Pack, battery charger, or when the detector, its component, or accessory is dropped, unplug the power supply from the AC outlet, and inform your establishment safety representative immediately to contact your dealer, distributor, or PerkinElmer. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.

Maintenance and Inspection

U S E R M A N U A L

WARNING

Caution

Turn OFF the power of the 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 detector system is going to be cleaned, turn OFF the XRpad™ 4336 MED, remove the XRpad™ LBP, and or unplug the power supply cable from the AC outlet. 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 XRpad™ 4336 MED must be repaired by PerkinElmer authorized 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 recommendation for inspecting the detector before use.

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Table of Contents

Scope ............................................................................................................. 9

Intended Use / Indication for Use .......................................................... 9

Audience ....................................................................................................... 9

Abbreviations .............................................................................................. 9

References .................................................................................................... 9

Definition of Symbols .............................................................................. 10

U S E R M A N U A L

Regulations ................................................................................................ 11

Description of the XRpad™ 4336 MED .............................................. 12

8.1 Detector Overview ............................................................................................................................ 12

8.2 Main Detector Specification ............................................................................................................ 13

8.3 Environmental Considerations ...................................................................................................... 13

8.4 Detector Dimensions ........................................................................................................................ 14

8.5 Detector Accessories ......................................................................................................................... 15

8.5.1 Rechargeable Lithium Battery Pack XRpad™ LBP ......................................................... 16

8.5.2 Interface and Power Unit XRpad™ IPU ............................................................................. 19

8.6 Minimum Computer Requirements .............................................................................................. 21

8.7 Operation .............................................................................................................................................. 21

8.7.1 Wired Detector Operation ....................................................................................................... 22

8.7.2 Wireless Detector Operation ................................................................................................... 23

8.7.3 Before Using the X-ray Detector ........................................................................................... 23

8.7.4 Power Down the XRpad™ 4336 MED ................................................................................ 24

8.7.5 General Workflow ...................................................................................................................... 25

Inspection and Maintenance................................................................... 26

9.1 Daily Inspection ................................................................................................................................. 26

9.1.1 Before Turning ON the Power ............................................................................................... 26

9.1.2 After Turning ON the Power .................................................................................................. 26

9.1.3 After Turning OFF the Power ............................................................................................... 27

9.2 Monthly Inspection ........................................................................................................................... 27

9.3 Yearly Inspection ............................................................................................................................... 28

9.4 Calibration ........................................................................................................................................... 28

9.5 Cleaning the Detector ....................................................................................................................... 28

10 After-Sales Service for PerkinElmer Products ................................... 29

11 Disposal ...................................................................................................... 29

12 Declarations ............................................................................................... 30

12.1 Guidance and Manufacturer’s Declaration ................................................................................. 30

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12.2 Industry Canada statement: ..................................................... Error! Bookmark not defined.

12.3 Declaration of Conformity for European Union (and EEA)Error! Bookmark not defined.

12.4 Federal Communication Commission Interference Statement (US)Error! Bookmark not

defined.

List of Figures

U S E R M A N U A L

Figure 1 Detector Overview (Front View) .................................................................................................. 12

Figure 2 Detector Dimensions ........................................................................................................................ 14

Figure 3 Patient Vicinity ................................................................................................................................... 15

Figure 4 Rechargeable Lithium Battery Pack XRpad™ LBP ................................................................ 16

Figure 5 Removal of the XRpad™ LBP ....................................................................................................... 18

Figure 6 XRpad™ IPU Overview .................................................................................................................. 19

Figure 7 Wired Connection of the XRpad™ ............................................................................................... 22

Figure 8 Wireless Connection of the XRpad™ .......................................................................................... 23

Figure 9 General Workflow ............................................................................................................................. 25

List of Tables

Table 1 Abbreviations ......................................................................................................................................... 9

Table 2 References ............................................................................................................................................... 9

Table 3 Symbols ................................................................................................................................................. 10

Table 4 Standards and Regulations .............................................................................................................. 11

Table 5 Detector Overview ............................................................................................................................ 12

Table 6 Main Detector Specification ............................................................................................................ 13

Table 7 Environmental Considerations ...................................................................................................... 13

Table 8 Accessories for the XRpad™ 4336 ............................................................................................... 15

Table 9 Specification of the XRpad™ LBP ................................................................................................ 16

Table 10 XRpad™ IPU Overview .................................................................................................................. 19

Table 11 Specification of the XRpad™ IPU ................................................................................................ 20

Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions ....................... 30

Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity ........................ 30

Table 14 Recommended Separation Distance between Portable and Mobile RF-Communication

Equipment and the X-Ray Detector ............................................................................................. 31

Table 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (Portable

Equipment) .......................................................................................................................................... 31

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1 Scope

This document describes design elements and respective interfaces for the XRpad™ 4336 MED detector. Applicable mechanical, electronic, and software interfaces are addressed. PerkinElmer digital X-ray Flat Panel Detectors and accessories are 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.

2 Intended Use / Indication for Use

The XRpad™ 4336 MED detector, when used with a radiographic imaging system, is intended for use in 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. It is not intended for mammographic use. 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 PerkinElmer XRpad™ 4336 MED detector.

U S E R M A N U A L

3 Audience

This document is for professional users from Original Equipment Manufacturers (OEMs) and system installers who are responsible for installing the XRpad™ 4336 MED detector into an x-ray system.

4 Abbreviations

Table 1 Abbreviations

Abbreviation Description FoV Field of View fps Frames per second I/F Interface IP Internet Protocol LED Light Emitting Diode SF Screen Film CR Computed Radiography DR Digital Radiography OEM Original Equipment Manufacturer

5 References

Table 2 References

Document Name Document # 1 XRpad™ LBC Reference Manual 620-005121-002 2 XRpad™ LBP Reference Manual 620-005149-001 3 Digital Radiography Software Manual Supplied by OEM

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XRpad

4336

6 Definition of Symbols

Table 3 Symbols

Symbol

This Way Up

Handle with Care

Keep Dry

Reusable

Description

Disposal (WEEE)

Refer to Instruction Manual

U S E R M A N U A L

Caution

Manufacturer‘s name and address.

Date of Manufacture, YYYY=Year, MM=Month

Authorized representative in the European Community

Protection Class I

Wireless Connectivity / LAN Connection / Missing LAN Connection

Material Number Serial Number AC Input

D.C. Voltage Temperature Limitation

Relative Humidity Limitation Potential Equalization

Functional Earth Connection

Protection Class II

EMI Sensitive Component

Battery charge condition

• Battery Charged (> 75%)

• Battery ¾ (<= 75%)

• Battery Half (<= 50%)

• Battery Low (<= 25%)

• Battery Empty (<= 10%)

• No Battery

Trigger Connection Push Button Power Switch

Do not crush

Do not expose to fire Keep away from children. UL Recognized component mark for US and Canada

Conformity European - Hereby, PerkinElmer Inc., declares that this

0050

MED is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC and 93/42/EEC. “0050” shows the notified body number for MDD.

™

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+ 24 hidden pages

Varex Imaging Deutschland XRPAD4336 Users manual

Specifications and Main Features

Frequently Asked Questions

User Manual