Perkin-Elmer XRpad2 4336 User Manual Download Page 1

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IGIT

MAGING

68153 01

XRpad2 4336 Digital X-ray
Detector System User 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 accessible.

Summary of Contents for XRpad2 4336

Page 1: ...336 Digital X ray Detector System User 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 accessible ...

Page 2: ...ufacturer 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 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 precaution...

Page 3: ... of the detector may result 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 severe personal injury death or substantial product damage WARNING This indicates a potentially hazardous situation which if ignored may result in severe personal injury death...

Page 4: ...onment 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 whic...

Page 5: ...s warning may cause electrical 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 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 f...

Page 6: ...lat 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 Caution Do not exceed the maximum uniform load weight of 150 kg distributed across the surface of th...

Page 7: ...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 WARNING 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 WARNING Use only charging devices appro...

Page 8: ...ed by non OEM approved components WARNING 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 WARNING Follow the laws and regulations for each country and select the regional code accordingly WARNING Do not use the detector in aircraft because there is a potential affect to aviation systems Caution Use...

Page 9: ...ng 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 WARNING If any abnormal condition such as smoke fumes or strange sounds is evident turn off th...

Page 10: ...y 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 WARNING The X ray detector must be repa...

Page 11: ...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 9 0 Inspection an...

Page 12: ...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 ...

Page 13: ... 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 Figure 10 Workflow for Acquiring an Image 28 ...

Page 14: ...This page intentionally left blank xiv www perkinelmer com 68153 01 List of Figures XRpad2 4336 ...

Page 15: ...etector 11 Table 9 Specification of the XRpad2 LBP 14 Table 10 Overview of the XRpad IPU 2 19 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 ...

Page 16: ...xvi www perkinelmer com 68153 01 List of Tables XRpad2 4336 This page intentionally left blank ...

Page 17: ...y 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 ...

Page 18: ... second GigE Gigabit 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 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 healthcare practiti...

Page 19: ...Battery Pack 48772 3 XRpad2 4336 Digital X ray Detector System Reference Manual 69652 4 Digital Radiography Software Manual Supplied by X ray system manufacturer or third party provider 5 Digital Radiography Software Supplied by X ray system manufacturer or third party provider 6 Access Point Manual Supplied by the Access Point Manufacturer or third party provider Table 3 Symbols Symbol Descriptio...

Page 20: ... Connection Protection Class I Protection Class II Non Ionizing Radiation Battery charge condition Battery Charged 75 Battery 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 Table 3 Symbols Continued ...

Page 21: ...ral 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 Frequen...

Page 22: ...Front View Standards and Regulations Description EN ISO 10993 10 2010 2013 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization EN ISO 4090 2004 Photography Medical Radiographic Cassettes Screens Films and Hard Copy Imaging Films Dimensions and Specifications EN 60529 1991 A1 2000 Degrees of Protection Provided by Enclosures IP code Table 5 Overview of the X...

Page 23: ...Connection 5 Push Button with a LED blue light Short press and LED OFF Power ON and LED flashes Short press and LED ON or flashes Switch On of the display Long Press 4s 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 LED ON Detector is not connected to the softw...

Page 24: ...t lifetime Table 6 Environmental Considerations Environment Transportation Storagea a In original transport container for 365 days Operation Ambient Temperatureb 30d 365d b Temp Gradient max 4 5 K hour 10 C to 55 C 0 C to 55 C 10 C to 35 C Relative Humidity 5 to 90 10 to 85 Atmospheric Pressure 520 hPa to 1070 hPa 690 hPa to 1070 hPa Vibrationc EN60068 2 64 c Image quality cannot be guaranteed dur...

Page 25: ... ISO 4090 for 35 cm 43 cm 14 17 cassette size Active Area 352 4mm x 428 8 mm External Dimensions 384 mm w 460 mm l 15 mm h Weight 3 1 kg Housing Aluminum frame with carbon fiber entrance window Communication Status Display OLED display with Wi Fi LAN battery and sensor indicators Wireless Data I F 802 11n Wi Fi standard 5 GHz Channel WAP 36 48 149 165 Stationary 36 48 149 165 Stationary DFS a 52 6...

Page 26: ...10 68153 01 D IGITAL I MAGING 8 4 X ray Detector Dimensions Figure 2 shows the dimensions for the X ray detector Figure 2 Dimensions for the X ray Detector 0 0 460 383 6 15 5 41 8 341 8 219 9 61 95 116 25 230 383 5 ...

Page 27: ...The imaging workstation and the Wi Fi access point must comply with IEC 60601 1 and or IEC 60950 1 depending on the usage and application Table 8 includes a list of accessories for the X ray detector Table 8 Accessories for the X ray Detector PerkinElmer Article No Description 95510949H 01 XRpad2 LBP Lithium Battery Pack 95510921H XRpad LBC Lithium Battery Charger 95510928H XRpad IPU 2 Interface P...

Page 28: ...hown in Figure 3 Figure 3 Patient Vicinity WARNING Connection of the X ray detector directly to the clinical computer network may disturb the IT environment WARNING Do not use any non medical equipment such as the Battery Charger or Wi Fi access point in the patient environment 1 5 m 1 5 m 2 5 m 1 5 m 1 5 m ...

Page 29: ...P Figure 4 shows the XRpad2 LBP Figure 4 XRpad2 LBP WARNING Storage or use of the Lithium Battery Pack environmental conditions outside the specification may cause fire electrical shock and unknown hazards which may result in severe personal injury death or substantial product damage or reduced product lifetime ...

Page 30: ... unused Upon initial use or after a prolonged storage period the battery may require three to four charge discharge cycles before achieving maximum capacity The actual battery run time will depend on the power demands made by the X ray detector The XRpad2 LBP is keyed and can only be inserted into the XRpad LBC charger in one orientation Table 9 Specification of the XRpad2 LBP General REF 95510949...

Page 31: ...to prevent it from dropping or slipping 2 Check to ensure the battery compartment of the X ray detector is clean dry and free of foreign contamination or debris If cleaning is necessary see Section 8 5 1 6 Cleaning the XRpad2 LBP on page 17 for cleaning instructions 3 Check to ensure the XRpad2 LBP is clean dry and free of foreign contamination or debris If cleaning is necessary refer to Section 8...

Page 32: ... using a slow and steady pulling motion supporting both the X ray detector and the XRpad2 LBP 4 Store the XRpad2 LBP in a cool dry clean environment if not in use or when recharging the XRpad2 LBP for the next use Figure 5 Removing the XRpad2 LBP 8 5 1 4 Transportation and Storage When transporting and storing the XRpad2 LBP Follow all local state and federal national regulations for handling pack...

Page 33: ...ot disassemble No modification of this product is allowed If the XRpad2 LBP emits an odor or generates heat or in any way appears abnormal during use recharging or storing immediately remove it from the device or battery charger and stop using the XRpad2 LBP Using a damaged or defective XRpad2 LBP may reduce function time or cause the X ray detector system to fail If an XRpad2 LBP leaks do not tou...

Page 34: ...erface Detector 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 cable The maximum cable length is 31m The AC cable must be connected to a properly grounded receptacle The AC cable is remov able and will be plugged to an IEC connector The XRpad IPU 2 mu...

Page 35: ...aded 3 Status LED Yellow LED Yellow N A LED Green N A 4 XRpad Interface and Power I O 1 5 Trigger Out Signal to Generator 6 Trigger In Signal from Hand Switch Prep Expose 7 Trigger In Out I F 8 XRpad Interface and Power I O 9 TRIG IN Signal 10 TRIG OUT Signal 11 LAN Port to Imaging Workstation 12 USB Connector 13 Remote Detector Power 14 Potential Equalization Connector 15 Functional Ground Connec...

Page 36: ...V 5 V SELV Trigger Out Signal 7 10 3 3 V DC Output 5PF 7 5 V 100 mA Mechanical Specification Size 260 mm L 205 mm W 50 mm H Temperature Ranges Operating 10 C to 35 C Transportation Storage 10 C 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 the IPU ...

Page 37: ...ntrols the X 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 Firewall is used make sure that it allows a connection to the detector 6 Access Point a WPA2 encryption support b 802 11n standard with 20 MHz channel bandwidth 36 48 52 64 100 116 132 140 149 ...

Page 38: ...ation The following sections describe the different use cases WARNING Do not exceed the maximum uniform load weight of 150 kg distributed across the surface of the X ray detector WARNING Do not exceed the maximum load weight of 100 kg distributed at one location in a 40mm diameter of the X ray detector surface Caution Check the threshold of the auto trigger mode regularly Caution Do not acquire im...

Page 39: ...onnected directly with the clinical network The Trigger I F of the XRpad IPU 2 must be connected with the Generator and with the Hand switch if the detector is used in external trigger mode The XRpad IPU 2 communicates using a standard Gigabit Ethernet network Interface and comes equipped with an RJ45 interface port Due to the overall network traffic it is recommended that you use this interface i...

Page 40: ... Fi Access Point may be wall or ceiling mounted to maximize wireless signal strength Make sure that the router is not connected directly to the clinical network The detector can also be connected directly to the Imaging Workstation using WLAN with the WAP mode of the detector see Figure 9 Before imaging make sure that the XRpad2 LBP charge is sufficient and the X ray detector antenna is not obstru...

Page 41: ...sappears before powering 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 this may cause fire electrical shock and unknown hazards which may result in severe personal injury death or substantial product damage Caution The X ray detector should only b...

Page 42: ...conds During the initialization of the detector the detector push button LED starts flashing 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 Radiography Imaging Software has initialized the detector the X ray detector LED starts flashing 8 7 4 2 Wireless...

Page 43: ... X ray detector Figure 1 5 wireless and wired mode XRpad IPU 2 push button Figure 6 5 wired mode Extended hand switch push button wired mode 8 7 6 General Workflow for Acquiring an Image Figure 10 shows the procedure for acquiring a clinical image after starting the Radiography Imaging Software Details of the Radiography Imaging Software and the X ray generator are described in their corresponding...

Page 44: ...e patient information Prepare the examination setup x Arrange the patient x Position the XͲray collimator x Check all conditions x Start the Software capturing button Conduct the examination x Press the Prep switch x Press the Exposure switch Check the captured images Turn off the detector Communication Mode Remove the battery pack for recharging Switch off the Interface Power Unit IPU End Wireles...

Page 45: ...s of the checklist 9 1 Daily Inspection Perform the following inspection daily If there is any problem immediately ask your establish ment s safety representative to contact your dealer distributor or device manufacturer 9 1 1 Before Turning On the Power WARNING The X ray detector must be repaired by PerkinElmer authorized personnel only Ignoring this warning may result in explosion fire electric ...

Page 46: ...cycle the old one 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 the Protective Insert into the battery compartment as described in Section 8 5 1 3 Removing the XRpad2 LBP on page 16 Check that the Battery Pack is not damaged Good Bad Good Bad Good Ba...

Page 47: ...xchange the Battery Pack with 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 in the Digital Radiography Software Manual Good Bad Good Bad Good Bad If any error messages appear follow the instructions in the Digital Radiography Software Manual If ...

Page 48: ... files as described 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 Bad Good Bad Use the instructions in Section 8 5 1 6 Cleaning the XRpad2 LBP on page 17 for cleaning Check the manufacturing date of all Battery Packs to ensure that their age is not fiv...

Page 49: ...compartment of the X ray detector 4 Remove any excess detergent or solution 5 Wipe the X ray detector surface with a clean cloth to completely dry the X ray detector 6 Allow the X ray detector to completely air dry before turning on or storing the X ray detector WARNING Do not acquire images and calibration files while handling the detector This can disturb the image quality and result in the wron...

Page 50: ...rized personnel The detector and its accessories are not intended to be repaired in the field For product returns contact your distributor or device manufacturer for shipping and packaging instructions Do not return products to PerkinElmer for repair or service without advance notifi cation Include all required papers in the shipment If the X ray detector or accessories have been contaminated with...

Page 51: ...atment of WEEE is indispensable in order to avoid the dispersion of pollutants into the recy cled material or waste stream Such treatment is the most effective means of protecting the cus tomer s environment Requirements for waste collection reuse recycling and recovery programs vary by regulatory authority at your location Contact your local responsible body for example your hospital clinic estab...

Page 52: ...Guidance RF emissions 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 equipment Should any interference EMC be detected with any other equipment reposition the X ray detector or the other equipment away from each other RF emissions CISPR 11 Class B wireless Cl...

Page 53: ...y should be at least 30 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 5 1 kV 2 kV 1 kV 2 kV Mains power quality should be that of a typical commercial and or hospital environment Power frequency magnetic field IEC 61000 4 8 3 A m 3 A m Power freq...

Page 54: ...ated Maximum Output 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 maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter ...

Page 55: ...er and d is the recommended 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 occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and l...

Page 56: ...ns pertinentes de la directive 1999 5 CE Ελληνική ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Η PerkinElmer Inc ΔΗΛΩΝΕΙ ΟΤΙ ΤΟ XRpad2 4336 ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999 5 ΕΚ Italiano Con la presente PerkinElmer Inc dichiara che questo XRpad2 4336 è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti della direttiva 1999 5 CE Íslenska Her með l...

Page 57: ...tiva 1999 5 CE Suomi PerkinElmer Inc vakuuttaa taten etta XRpad2 4336 tyyppinen laite on direktiivin 1999 5 EY oleellisten vaatimusten ja sita koskevien direktiivin muiden ehtojen mukainen Slovensko PerkinElmer Inc izjavlja da je ta XRpad2 4336 v skladu z bistvenimi zahtevami in ostalimi relevantnimi dolocili direktive 1999 5 ES Svenska Härmed intygar PerkinElmer Inc att denna XRpad2 4336 står I ö...

Page 58: ...ipment generates uses 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 a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his or her own expense The country code selection i...

Page 59: ...n is only applicable to 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 antenna gain permitted for devices in the bands 5250 5350 MHz and 5470 5725 MHz shall comply with the e i r p limit WARNING The maximum antenna gain permitted for devices in the b...

Page 60: ...en des Communications Cet équipement ne dépasse pas les limites de la classe A pour les émissions rayonnées telles que définies dans le règlement sur le brouillage radioélectrique édicté par le ministère des Communi cations du Canada CAN ICES 3 A NMB 3 A CAN NMB 3 A 3 Section is only applicable to Canada Mise en garde Le dispositif fonctionnant dans la bande 5 150 5 250 MHz est réservé exclusiveme...

Page 61: ...GITAL I MAGING 12 6 Korean Type of Equipment User s Guide A 급 기기 업무용 방송통신기자재 이 기기는 업무용 A 급 전자파적합기기로서 판 매자 또는 사용자는 이 점을 주의하시기 바라 며 가정외의 지역에서 사용하는 것을 목적으로 합니다 주의 해당 무선설비는 전파혼신 가능성이 있으므로 인명안전과 관련된 서비스는 할 수 없음 해당 무선 설비는 5150 5250MHz 대역에서 실내 에서만 사용할 수 있음 ...

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Page 63: ...rer s 36 Industrie Canada declaration 44 Industry Canada statement 43 Korean 45 of conformity of European Union and EEA 40 definition of symbols 3 description X ray detector 6 XRpad IPU 2 18 dimensions for the X ray detector 10 disposing of X ray detector 35 XRpad LBP 18 E environmental considerations 8 F Federal Communication Commission interface statement 42 for your safety iii G general workflo...

Page 64: ...ndling vi if a problem occurs ix installation and environment of use iv interface and power unit and cables v maintenance and inspection x WLAN viii safety for your iii scope 1 service after sales for PerkinElmer products 34 specification X ray detector 9 XRpad IPU 2 20 XRpad LBP 14 standards and regulations 5 storage and transportation 16 symbols definition of 3 system requirements minimum 21 T t...

Page 65: ...kinelmer com 49 XRpad2 4336 Index XRpad IPU 2 cleaning 21 description 18 overview 19 specification 20 XRpad LBP 13 charging 14 cleaning 17 disposing of 18 installing 15 maintaining 17 removing 16 specification 14 Y yearly inspection 32 ...

Page 66: ...This page intentionally left blank 50 www perkinelmer com 68153 01 Index XRpad2 4336 ...

Page 67: ...kinelmer com For a complete listing of our global offices visit www perkinelmer com 2015 PerkinElmer Inc All rights reserved The PerkinElmer logo and design are registered trademarks of PerkinElmer Inc or its subsidiaries in the United States and other countries All other trademarks not owned by PerkinElmer Inc or its subsidiaries that are depicted herein are the property of their respective owner...

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