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XRpad2 4343

46

www.vareximaging.com

U

SER

 M

ANUAL

14.2

Declaration of Conformity for European Union 
(and EEA)

 

English

Hereby, Varex Imaging declares that this XRpad2 4343 is in compliance with the essential 
requirements and other relevant provisions of Directive 2014/53/EU.

Č

esky

Varex Imaging tímto prohlašuje, že tento XRpad2 4343 je ve shod

ě

 se základními 

požadavky a dalšími p

ř

íslušnými ustanoveními sm

ě

rnice 2014/53/EU.

Dansk

Varex Imaging erklærer herved, at denne XRpad2 4343 overholder de væsentlige krav 
samt øvrige relevante bestemmelser i direktiv 2014/53/EU.

Deutsch

Hiermit erklärt Varex Imaging, dass der XRpad2 4343 den grundlegenden Anforderungen 
und anderen einschlägigen Bestimmungen der Richtlinie 2014/53/EU entspricht.

Eesti

Käesolevaga kinnitab Varex Imaging seadme XRpad2 4343 vastavust direktiivi 2014/53/
EU põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele 
sätetele.

Español

Por medio de la presente, Varex Imaging declara que el XRpad2 4343 cumple con 
los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la 
Directiva 2014/53/EU.

Français

Par la présente, Varex Imaging déclare que ce XRpad2 4343 est en conformité avec les 
exigences essentielles et autres dispositions pertinentes de la directive 
2014/53/EU.

Ελληνική

ΜΕ

 

ΤΗΝ

 

ΠΑΡΟΥΣΑ

 

Η

 Varex Imaging 

ΔΗΛΩΝΕΙ

 

ΟΤΙ

 

ΤΟ

 XRpad2 4343 

ΣΥΜΜΟΡΦΩΝΕΤΑΙ

 

ΠΡΟΣ

 

ΤΙΣ

 

ΟΥΣΙΩΔΕΙΣ

 

ΑΠΑΙΤΗΣΕΙΣ

 

ΚΑΙ

 

ΤΙΣ

 

ΛΟΙΠΕΣ

 

ΣΧΕΤΙΚΕΣ

 

ΔΙΑΤΑΞΕΙΣ

 

ΤΗΣ

 

ΟΔΗΓΙΑΣ

 2014/53/EU.

Italiano

Con la presente, Varex Imaging dichiara che questo XRpad2 4343 è conforme ai requisiti 
essenziali ed alle altre disposizioni pertinenti della direttiva 2014/53/EU.

Íslenska

Her með lýsir Varex Imaging yfir þvi að XRpad2 4343 er í samræmi við 
grunnkröfur og aðrar kröfur, sem gerðar eru í tilskipun 2014/53/EU.

Latviski

Ar šo Varex Imaging pazi

ņ

o, ka XRpad2 4343 atbilst Direkt

ī

vas 2014/53/EU b

ū

tiskaj

ā

m 

pras

ī

b

ā

m un citiem ar to saist

ī

tiem noteikumiem.

Lietuviu

Varex Imaging patvirtina, kad šis XRpad2 4343 atitinka Direktyvos 
2014/53/EU esminius reikalavimus ir kitas nuostatas.

Malti

Hawnhekk, Varex Imaging, jiddikjara li dan XRpad2 4343 jikkonforma 
mal-

ħ

ti

ġ

ijiet essenzjali u ma provvedimenti o

ħ

rajn relevanti li hemm fid-Dirrettiva 

2014/53/EU.

Magyar

Alulírott, Varex Imaging nyilatkozom, hogy az XRpad2 4343 megfelel a vonatkozó 
alapvet

ő

 követelményeknek és az 2014/53/EU irányelv egyéb el

ő

írásainak.

Nederlands Hierbij verklaart Varex Imaging dat het toestel XRpad2 4343 in overeenstemming is met 

de essentiele eisen en de andere relevante bepalingen van richtlijn 2014/53/EU.

Norsk

Varex Imaging erklærer herved at utstyret XRpad2 4343 er i samsvar med 
de grunnleggende krav og øvrige relevante krav i direktiv 2014/53/EU.

Polski

Niniejszym Varex Imaging oswiadcza, ze XRpad2 4343 jest zgodny z zasadniczymi 
wymogami oraz pozostalymi stosownymi postanowieniami Dyrektywy 2014/53/EU.

Version 

01 

2017-11-03

Содержание XRpad2 4343

Страница 1: ...ser Manual 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 accessib...

Страница 2: ...laws pertaining to the privacy of image data In no event is Varex liable for direct indirect or consequential injury damage or loss of equipment operation time or image data arising from the use of t...

Страница 3: ...ult in personal injury death or product damage Keep this manual for future reference Meaning of Alerts and Notes DANGER This indicates a potentially hazardous situation which if ignored will result in...

Страница 4: ...ge acquisition must be assessed for the specific intended use and application For the most reliable image acquisition method use of the external or software trigger mode to synchronize with the X ray...

Страница 5: ...nvironment Dusty environment Salty or sulphurous environment Near a vibrating environment Environment where there is insufficient air circulation to enable the X ray detector and power supply to dissi...

Страница 6: ...al shock which may result in severe personal injury death or substantial product damage WARNING Do not modify the cables or subject the cable to external stress or damage Avoid placing anything heavy...

Страница 7: ...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...

Страница 8: ...LBP to release toxic and harmful substances causing injuries such as electric shock or burns or cause a fire and will render the pack unusable WARNING Observe and follow all safety information in this...

Страница 9: ...tructed by metal wood or a human body the wireless communication can be slowed down or disconnected WARNING Follow the laws and regulations for each country and select the regional code accordingly WA...

Страница 10: ...he most reliable image acquisition method use of the external or software trigger mode to synchronize with the X ray source is recommended WARNING The external sync mode is the default acquisition mod...

Страница 11: ...e under abnormal conditions may result in severe personal injury death or substantial product damage WARNING When liquid has been spilled into or on any part of the X ray detector or power supply if a...

Страница 12: ...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 Ignorin...

Страница 13: ...mensions 15 10 5 X ray Detector Accessories and Replacement Parts 16 10 5 1 Rechargeable Battery Pack 18 10 5 2 XRpad IPU 2 23 10 6 Minimum System Requirements 26 10 7 Operating the X ray Detector 27...

Страница 14: ...Cleaning the X ray Detector 39 11 5 3 Disinfecting the X ray Detector 39 11 6 Error Messages and Troubleshooting 40 12 0 After Sales Service for Varex Products 40 13 0 Disposing of the X ray Detector...

Страница 15: ...ure 14 Figure 6 Dimensions for the X ray Detector 15 Figure 7 Patient Vicinity 17 Figure 8 XRpad2 LBP 18 Figure 9 Removing the Battery Pack 21 Figure 10 XRpad IPU 2 23 Figure 11 Wired Connection of th...

Страница 16: ...This page intentionally left blank xvi www vareximaging com List of Figures XRpad2 4343 V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Страница 17: ...able 9 Specification of the Battery Pack 19 Table 10 Overview of the XRpad IPU 2 24 Table 11 Specification of the XRpad IPU 2 25 Table 12 Guidance and Manufacturer s Declaration of Electromagnetic Emi...

Страница 18: ...xviii www perkinelmer com List of Tables XRpad2 4343 This page intentionally left blank V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Страница 19: ...is the responsibility of the X ray system manufacturer to confirm the safety efficacy and compliance of the X ray system for its intended use inclusive of the detector The Digital Radiography Softwar...

Страница 20: ...igabit Ethernet 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...

Страница 21: ...e Document XRpad LBC Charger for Rechargeable Lithium Ion Battery Pack 48773 XRpad LBP Rechargeable Lithium Ion Battery Pack 48772 XRpad2 4343 Digital X ray Detector Reference Manual Digital Radiograp...

Страница 22: ...ts Refer to instruction manual booklet Refer to Instruction Manual Caution Manufacturer s name and address Date of Manufacture YYYY MM where YYYY Year MM Month OR Date of Manufacture YYYY MM DD where...

Страница 23: ...Temperature Warning Wireless Connectivity No Wireless Connectivity LAN Connection Missing LAN Connection Access Point Trigger Connection Detector Push Button Detector Power Switch on IPU Do not crush...

Страница 24: ...king for the product 0050 shows the notified body number for MDD Do not X ray backside Environmental Friendly Use Period of 10 years Intertek ETL Classified Logo United States 5005875 Intertek ETL Cla...

Страница 25: ...al electrical equipment Part 1 6 General requirements for basic safety and essential performance Usability Medical devices Part 1 Application of usability engineering to medical devices CAN CSA C22 2...

Страница 26: ...held and body mounted wireless communication devices used by the general public 30 MHz 6 GHz EN 62209 02 2012 Human exposure to radio frequency fields from hand held and body mounted wireless communic...

Страница 27: ...sette Figure 1 shows the front view of the X ray detector and Table 5 includes a brief description of each feature Figure 1 X ray Detector Front View Table 5 Overview of the X ray Detector 1 Active Ar...

Страница 28: ...Long Press 4 s and LED ON or flashes Power OFF LED Status blue light LED OFF Detector is not powered LED flashing first instance Detector is initializing LED flashing second instance Detector is Ready...

Страница 29: ...vironmental Considerations Environment Transportation Storagea a In original transport container for 365 days Operation Ambient Temperatureb 14 days b Temp Gradient max 4 5 K hour 10 C to 55 C 0 C to...

Страница 30: ...s On board Memory 1 GB DDR3 8 GB SDHC card Mechanical Size ISO 4090 for 43 cm 43 cm 17 17 cassette size Active Area 426 mm 426 mm External Dimensions 460 mm w 460 mm l 15 5 mm h Weight 4 1 kg 9 03 lbs...

Страница 31: ...www vareximaging com 13 XRpad2 4343 U SER M ANUAL Figure 3 DQE vs Frequency a Country dependent V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Страница 32: ...XRpad2 4343 14 www vareximaging com U SER M ANUAL Figure 4 MTF vs Frequency Figure 5 Plot of Characteristic Curve Signal vs Exposure V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Страница 33: ...ximaging com 15 XRpad2 4343 U SER M ANUAL 10 4 X ray Detector Dimensions Figure 6 shows the dimensions in mm for the X ray detector Figure 6 Dimensions for the X ray Detector V e r s i o n 0 1 2 0 1 7...

Страница 34: ...t must comply with IEC 60601 1 or IEC 60950 1 Table 8 includes a list of accessories and replacement parts for the X ray detector Table 8 Accessories and Replacement Parts for the X ray Detector Varex...

Страница 35: ...7 Figure 7 Patient Vicinity WARNING Connection of the X ray detector directly to the installed computer network may disturb the IT environment WARNING Do not use any non medical equipment such as the...

Страница 36: ...the battery are for reference only and may be different or subject to change WARNING Storage or use of the battery pack environmental conditions outside the specification may cause fire electrical sh...

Страница 37: ...before achieving maximum capacity The actual battery run time will depend on the power demands made by the X ray detector The battery pack is keyed and can only be inserted into the battery charger i...

Страница 38: ...ck is clean dry and free of foreign contamination or debris If cleaning is necessary refer to Section 10 5 1 6 Cleaning the Battery Pack on page 22 for cleaning instructions 4 The battery pack is keye...

Страница 39: ...and federal national regulations for handling packaging labeling and transporting Lithium Ion batteries Before transporting the battery inspect it to confirm that there is no damage or leakage from t...

Страница 40: ...the device or battery charger and stop using the battery pack Using a damaged or defective battery pack may reduce function time or cause the X ray detector system to fail If an battery pack leaks do...

Страница 41: ...or Trigger Interface Hand Switch and Generator Interface and Detector Push Button Interface The Gigabit Ethernet Interface of the XRpad IPU 2 is connected to the Imaging Workstation using a Cat 5e 6 c...

Страница 42: ...ow LED Yellow USB trigger function enabled LED Green Remote Detector Power via USB 4 XRpad Interface and Power I O 1 5 Trigger Out Signal to Generator 6 Trigger In Signal from Hand Switch Prep Expose...

Страница 43: ...to 70 C Relative Humidity Operating 10 to 90 Transportation Storage 0 to 90 Ingress Protection Rating IP40 rated protection against particles 1 mm WARNING All external signals that are connected to t...

Страница 44: ...ray detector 1 Gigabit Ethernet Infrastructure and a free Gigabit Ethernet Port or Wi Fi Infrastructure 2 Intel compatible Multi Core Processor 2 GHz 3 RAM 4 GB 4 Windows 7 32 bit 64 bit 5 If a Firew...

Страница 45: ...tions installation method X ray system setup and subject to be imaged the use of AED mode may result in false trigger or no trigger of X ray image acquisition The risk of false trigger or no trigger o...

Страница 46: ...kstation using a Cat 5e 6 cable Make sure that the XRpad IPU 2 is not connected directly with the installed network The Trigger I F of the XRpad IPU 2 must be connected with the Generator and with the...

Страница 47: ...nt may be wall or ceiling mounted to maximize wireless signal strength Make sure that the router is not connected directly to the installed network The detector can also be connected directly to the I...

Страница 48: ...on the X ray detector WARNING If the X ray detector system is used under conditions where condensation can occur problems in image quality or malfunction of the detector system may occur In addition...

Страница 49: ...ing Once the X ray detector is powered on the X ray detector display is on and shows the current status of the X ray detector The X ray detector LED will turn from flashing to constant on After the Ra...

Страница 50: ...a temperature symbol on the detector display informing the user of the temperature When the near thermal limit occurs typically 41 C immediately finish the exam and then power down the detector to re...

Страница 51: ...rmation Prepare the examination setup x Arrange the patient x Position the X ray collimator x Check all conditions x Start the Software capturing button Conduct the examination x Press the Prep switch...

Страница 52: ...11 1 Daily Inspection Perform the following inspection daily If there is any problem immediately ask your establishment s safety representative to contact your dealer distributor or device manufactur...

Страница 53: ...ne Check that the battery pack wireless mode or the Protective Insert wired mode is in the battery compartment and the sliding latches are closed Good Bad Good Bad Good Bad Slide the battery pack or t...

Страница 54: ...a charged one Check that the detector LED is ON Good Bad Good Bad Good Bad Set the Detector to Exposure Ready as described in the Digital Radiography Software Manual Perform test exposure as described...

Страница 55: ...ibed in the Digital Radiography Software Manual Contact your dealer distributor or device manufacturer if there is any problem Make sure that the XRpad IPU 2 is clean from dirt or dust Good Bad Good B...

Страница 56: ...Germicidal Disposable Wipes or Clinell Universal Wipes 1 4 Hydrogen Peroxide solution Commercial option Clorox Healthcare Hydrogen Peroxide Wipes All chemicals listed above as approved for use can be...

Страница 57: ...opyl alcohol wipe and let air dry 11 5 3 Disinfecting the X ray Detector To disinfect the X ray detector 1 Turn off the X ray detector and the power and communication tethered cable if applicable 2 In...

Страница 58: ...or substantial product damage 12 0 After Sales Service for Varex Products Contact your sales person distributor or device manufacturer for after sales service including warranty or any other informat...

Страница 59: ...delines in your area The objectives of this program are to preserve protect and improve the quality of the environ ment protect human health and utilize natural resources prudently and rationally Spec...

Страница 60: ...ssions CISPR 11 Group 1 The X ray detector uses RF energy only for its internal function therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equip...

Страница 61: ...Electrical fast transients Burst IEC 61000 4 4 0 5 kV AC 1 kV DC 0 5 kV AC 1 kV DC Mains power quality should be that of a typical commercial and or hospital environment Transients Surges IEC 61000 4...

Страница 62: ...utput Power of the Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For a transmitter rated at a ma...

Страница 63: ...ded separation distance in meter m Field strengths outside the shielded location from fixed RF transmitters as determined by an electromagnetic site surveya should be less than 3 V m Interference may...

Страница 64: ...irective 2014 53 EU Varex Imaging XRpad2 4343 2014 53 EU Italiano Con la presente Varex Imaging dichiara che questo XRpad2 4343 conforme ai requisiti essenziali ed alle altre disposizioni pertinenti d...

Страница 65: ...Rpad2 4343 v skladu z bistvenimi zahtevami in ostalimi relevantnimi dolocili direktive 2014 53 EU Svenska H rmed intygar Varex Imaging att denna XRpad2 4343 st r I verensst mmelse med de v sentliga eg...

Страница 66: ...es and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in...

Страница 67: ...Canada Caution The device for operation in the band 5150 5250 MHz is only for indoor use to reduce the potential for harmful interference to co channel mobile satellite systems WARNING The maximum ant...

Страница 68: ...nada Mise en garde Le dispositif fonctionnant dans la bande 5 150 5 250 MHz est r serv exclusivement une utilisation en int rieur afin de r duire les risques d interf rences nuisibles pour les syst me...

Страница 69: ...stry Canada statement 49 of conformity of European Union and EEA 46 definition of symbols 4 description X ray detector 9 XRpad IPU 2 23 dimensions for the X ray detector 15 disinfecting and cleaning i...

Страница 70: ...maintenance and inspection xii WLAN ix safety for your iii scope 1 service after sales for Varex Imaging products 40 specification X ray detector 12 XRpad IPU 2 25 XRpad LBP 19 standards and regulatio...

Страница 71: ...4343 Index XRpad IPU 2 cleaning 26 description 23 overview 24 specification 25 XRpad LBP charging 19 cleaning 22 disposing of 23 installing 20 maintaining 22 specification 19 XRpad2 LBP 18 Y yearly in...

Страница 72: ...This page intentionally left blank 54 www vareximaging com Index XRpad2 4343 V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Страница 73: ...55 This page intentionally left blank V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Страница 74: ...ffices visit www vareximaging com 2017 Varex Imaging All rights reserved The Varex logo and design are registered trademarks of Varex Imaging or its subsidiaries in the United States and other countri...

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