CARESTREAM DRX-1 System Detector CARESTREAM DRX-1C System Detector CARESTREAM DRX 2530C Detector Model DRX 2530-01 User Guide Publication No.: AA5348 2012-12-20
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CARESTREAM DRX-1 System Detector CARESTREAM DRX 2530 Detector model DRX 2530-01 Publication Number AA5348 Revision A All rights reserved. No part of this manual may be reproduced or copied in any form by any means, such as graphic, electronic or mechanical, including photocopying, typing, or information retrieval systems without written permission. The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including consequential or special damages, resulting from any use of this information, even if loss or damage is caused by Carestream Health s negligence or other fault. Document Conventions Note Notes provide additional information, such as expanded explanations, hints, or reminders. Important Important highlights critical policy information that affects how you use this manual and this product. Caution Caution points out procedures that you must follow precisely to avoid damage to the system or any of its components, yourself or others, loss of data, or corruption of files in software applications. Contact Information Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 United States AA5348 2012-12-20 1
Authorized European Agent Carestream Health France 1, rue Galilée 93192 NOISY-LE-GRAND CEDEX FRANCE 2 AA5348 2012-12-20
Contents 1 Safety and Regulatory Information Medical Equipment Classification... 1-2 Product Safety Standards... 1-3 EMC Standards for the Detector... 1-4 Precautions... 1-4 FCC Notice (United States)... 1-5 Recommended EMC Environment... 1-6 Wireless Declaration... 1-9 2 Detector Operation Cautions... 2-2 DRX Detector Operation... 2-3 Insert the Battery Into the Detector... 2-5 Remove the Battery from the Detector... 2-6 Position the DRX-1 and DRX-1C System Detectors in a Bucky... 2-8 Using Detectors... 2-10 Tether Operation... 2-11 Tether Interface... 2-11 Labeling the Detector for Use... 2-13 Procedure to Apply the Label... 2-13 DRX Detector LED Display Matrix... 2-14 Disposal... 2-15 Transport and Storage Environment... 2-15 Operational Environment... 2-15 Equipment Maintenance... 2-16 Procedure to clean the detector... 2-16 Procedure to clean the battery footprint... 2-17 Patient Contact... 2-17 Shipping and Handling Labels... 2-18 Publication History... 2-19 AA5348 2012-12-12 1
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1 Safety and Regulatory Information This document applies to the CARESTREAM DRX-1 System Detector, the DRX-1C System Detector, and the DRX 2530C Detector (Model DRX 2530-01). Unless otherwise specified, these products will be referred to as product or the detector from this point forward. This product complies with 21 CFR 1020.30/31 Performance Standards for Radiation Safety Radiation Equipment. Caution For continued safe use of this equipment, follow the instructions contained in this operating manual. Study this manual carefully before using the equipment and keep it at hand for quick reference. Note For additional information on the products discussed in this manual, see the following: CARESTREAM DRX-1 System Battery and DRX Detector Battery User Guide CARESTREAM DRX-1 System Battery Charger User Guide CARESTREAM DRX-1 System User Guide CARESTREAM DRX-1 System Online Help AA5348 2012-12-20 1 1
Safety and Regulatory Information Medical Equipment Classification Table 1: CARESTREAM DRX-1 System Detector Medical Equipment Classification Specification Type of protection against electrical shock: Degree of protection against electrical shock: Degree of protection against ingress of water: Mode of operation: Flammable anesthetics: Description Internally powered equipment Class I or Class II Equipment a Type B Applied Part Ordinary protection Continuous operation Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide. a. Only internally powered unless the tether is connected. When the tether connected, the Class depends on the tether used: Tether Model DRX-1 System Tether Interface = Class I, Tether Model DRX-TPC1 = Class II Table 2: CARESTREAM DRX 2530 Detector Model DRX-2530-01 Medical Equipment Classification Specification Type of protection against electrical shock: Degree of protection against electrical shock: Degree of protection against ingress of water: Mode of operation: Flammable anesthetics: Description Internally powered equipment Class I or Class II Equipment a Type B Applied Part Ordinary protection Continuous operation Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide. a. Only internally powered unless the tether is connected. When the tether connected, the Class depends on the tether used: Tether Model DRX-1 System Tether Interface = Class I, Tether Model DRX-TPC1 = Class II 1 2 AA5348 2012-12-20
Safety and Regulatory Information Product Safety Standards The following Product Safety Standards apply to the CARESTREAM DRX-1 System Detector and the DRX 2530 Detector, model DRX-2530-01. USA UL 60601 1:2003 Medical Electrical Equipment ANSI/AAMI ES60601 1:2005 Medical Electrical Equipment Part 1: General requirements for safety and essential performance Canada CAN/CSA C22.2 No. 601.1 M90 (R2005) Medical Electrical Equipment CAN/CSA C22.2 No. 601.1S 94 (R1999) Supplement No. 1 94 to CAN/ CSA C22.2 No. 601.1 M90 CAN/CSA C22.2 No. 601.1B-90 (R2006) Amendment 2 to CAN/CSA C22.2 No. 601.1 M90 CAN/CSA C22.2 No. 60601 1 08 Medical Electrical Equipment Part 1: General requirements for safety and essential performance European Union EN 60601 1:1990 + Amendment 1:1993 + Amendment 2:1995 Medical Electrical Equipment EN 60601 1:2006 Medical Electrical Equipment Part 1: General requirements for safety and essential performance EN 60601 1 6:2010 Medical Electrical Equipment Part 1: General requirements for safety and essential performance Collateral Standard: Usability International IEC 60601 1:1988 + Amendment 1:1991 + Amendment 2:1995 Medical Electrical Equipment IEC 60601 1:2005 Medical Electrical Equipment Part 1: General requirements for safety and essential performance IEC 60601 1 6:2010 Medical Electrical Equipment Part 1: General requirements for safety and essential performance Collateral Standard: Usability 3rd edition AA5348 2012-12-20 1 3
Safety and Regulatory Information EMC Standards for the Detector Precautions IEC 60601 1 2:2007 includes EMC requirements and tests, Medical Electrical Equipment including CISPR 11:2009 + A 1:2010, Group 1, Class A. Electromagnetic Compatibility Precautions Medical electrical equipment requires special precautions regarding Electromagnetic Compatibility (EMC). Medical equipment must be installed and put into service according to the EMC information provided in this document. Communications Equipment Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment EMC performance. The wireless version of the detector operates with the 802.11n protocol in the 5 GHz frequency band. The radio output power is 50 mw (nominal). Replacement of Cables, Accessories, or Transducers The use of cables, accessories, or transducers, other than those specified in this document with the exception of transducers or cables sold by the manufacturer of the equipment as replacement parts for internal components, may result in increased emissions or decreased immunity of the medical equipment. Other Equipment The detector should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the detector should be observed to verify normal operation in the configuration in which it will be used. Shielded Locations The typical location of the detector will be in a shielded room only because the detector functions with sources of X-ray energy. The detector is fully compliant with the requirements of IEC 60601 1 2:2007 without being located in a shielded room. 1 4 AA5348 2012-12-20
Safety and Regulatory Information FCC Notice (United States) This device complies with part 15 of the FCC Rules. Operation of the device is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy. If it is not installed and used in accordance with the instruction manual, it 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 users will be required to correct the interference at their own expense. Changes or modifications not expressly approved by the manufacturer could void the user s authority to operate the equipment. Caution This is a Class A product. In a domestic environment, this product may cause radio interference, in which case the user may be required to take adequate measures. AA5348 2012-12-20 1 5
Safety and Regulatory Information Recommended EMC Environment Guidance and Manufacturer s Declaration Electromagnetic Emissions The detector is intended for use in the electromagnetic environment specified below. The customer or the user of the detector should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonics Emissions IEC 61000 3 2 Voltage Fluctuations/ Flicker Emissions IEC 61000 3 3 Group 1 Class A Class A Complies The 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. The detector is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic Immunity for Equipment and Detectors Fully Compliant with IEC 60601 1 2:2007 The detector is intended for use in the electromagnetic environment specified below. The customer or the user of the detector should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge (ESD) IEC 61000 4 2 ± 6 kv contact ± 8 kv air ± 6 kv contact ± 8 kv air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. 1 6 AA5348 2012-12-20
Safety and Regulatory Information Electromagnetic Immunity for Equipment and Detectors Fully Compliant with IEC 60601 1 2:2007 Electrical fast transient/ burst IEC 61000 4 4 ± 2 kv for power supply lines ± 1 kv for input/output lines ± 2 kv for power supply lines ± 1 kv for input/ output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000 4 5 ± 1 kv line to line ± 2 kv line to earth ± 1 kv line to line ± 2 kv line to earth Voltage dips, short interruptions, and voltage variations on power supply lines IEC 61000 4 11 < 5 % U T (> 95 % dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles < 5 % U T (> 95 % dip in U T ) for 5 sec < 5 % U T (> 95 % dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles < 5 % U T (> 95 % dip in U T ) for 5 sec Power frequency (50/60 Hz) magnetic field IEC 61000 4 8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note U T is the mains (ac) voltage prior to application of the test level. AA5348 2012-12-20 1 7
Safety and Regulatory Information Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the Detector. The detector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the detector can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the detector as recommended below, according to the maximum output of the communications equipment. Rated Maximum Output Power of Transmitter Watts Separation Distance According to Frequency of Transmitter Meters 150 khz 80 MHz d = 1.17 P 80 MHz 800 MHz d = 1.17 P 800 MHz 2.5 GHz d = 2.33 P 0.01 0.117 0.117 0.233 0.10 0.37 0.37 0.737 1 1.17 1.17 2.33 10 3.70 3.70 7.36 100 11.7 11.7 23.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 1 8 AA5348 2012-12-20
Safety and Regulatory Information Wireless Declaration CARESTREAM DRX-1, DRX-1C, and DRX 2530C Detectors Radio Frequency Exposure Declarations The CARESTEAM Detectors are portable wireless devices according to FCC regulation 2.1093 (b). The Detectors have been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general exposure limits specified in ANSI/IEEE standard C95.1 1999. The maximum SAR measurement (averaged over 1 gram of tissue) is 0.992 W/kg. The measured value is well under the spatial peak SAR of 1.6 W/ kg specified in FCC regulation 2.1093 d (2) for uncontrolled environment/general exposure conditions. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and gain should be so chosen that the equivalent istropically radiated power (e.i.r.p) is not more than that necessary for successful communication. Conformément à la réglementation d Industrie Canada, le présent emétteru radio peut fonctionner avec une antenne d un type et d un gain maximal (ou inférieur) approuvé pour l émetteur par Industrie Canada. AA5348 2012-12-20 1 9
Safety and Regulatory Information 1 10 AA5348 2012-12-20
2 Detector Operation A DRX detector can be used with analog or digital systems to capture images digitally. The detector operates in a wireless state, using a battery for power, and allowing wireless communication for control and data transmission. The battery-powered detector absorbs, measures, and translates into digital format the X-ray energy absorbed during an X-ray exposure. Software corrects the digital image and generates a preview and fullresolution image on the Console. Features Portable X-ray receptor Used on a table, behind a patient in a bed or wheelchair Transmits images wirelessly Battery operated Optional tether operation Note The DRX-1 System Detector and the DRX-1C System Detector may be used in a table or wall mounted Bucky. The DRX 2530C Detector, Model DRX 2530-01, is not used in a Bucky. It features portability and may be used in a wheelchair, on a table, in a patient s bed, or in a bassinet. AA5348 2012-12-20 2 1
Detector Operation Cautions Caution Follow all safety labels on equipment. The detector must be used only by qualified personnel and only after training in the specific operations. It is the operator s responsibility to ensure the patient s safety while the equipment operates by visual observation, proper patient positioning, and use of the protective devices provided. The detector is fragile and contains glass. Handle with care! Dropping or handling the detector roughly could result in damage. If the detector is dropped or handled roughly, or if there is any indication of reduced image quality, perform a calibration. Do not submerge the detector in liquid. Perform periodic maintenance to ensure continued safe use of the equipment. The detector must be repaired only by authorized service personnel. 2 2 AA5348 2012-12-20
Detector Operation DRX Detector Operation Figure 1: DRX-1System Detector, DRX-1C System Detector (front view) Figure 2: DRX-1System Detector, DRX-1C System Detector (rear view) AA5348 2012-12-20 2 3
Detector Operation Figure 3: DRX 2530C Detector (front view) 1 H224_0227AC Figure 4: DRX 2530C Detector (rear view) 2 H224_0228AC 1 Handle 2 Battery 2 4 AA5348 2012-12-20
Detector Operation Insert the Battery Into the Detector 1. Place a fully charged battery in the battery footprint in the detector so that the contacts on the back edge of the battery are inserted first. The battery fits into the detector only one way. See the CARESTREAM DRX-1 System Battery and DRX Detector Battery User Guide for technical information about the battery. 2. Push the battery down firmly until the latch catches. Figure 5: H224_0225AC Caution Use only the CARESTREAM DRX-1 System Battery in the DRX-1 and DRX-1C System Detectors. Use only the CARESTREAM DRX Detector Battery in the DRX 2530C Detector. AA5348 2012-12-20 2 5
Detector Operation Remove the Battery from the Detector Battery unlatch procedure for the CARESTREAM DRX-1 System Battery: Place a tool such as the tip of a ballpoint pen in the release slot and push down on the latch (1). Single Point Latch 1 The battery pops up and releases for easy removal. H224_0017GC 2 6 AA5348 2012-12-20
Detector Operation Battery unlatch procedure for the DRX Detector Battery: 1. Place the detector on a flat surface. 2. With one finger, press and hold the round button to release the latch (1). 3. With another finger, simultaneously pull the tab away from the battery (2). Both actions are required to release the battery. Figure 6: Two Point Latch 2 1 a b H224_0226GC The battery pops up and releases for easy removal. Note Do not pull on the latch tab (a) or spring (b). If this happens, the latch will lock open. Repeat the battery unlatch procedure to reset the tabs. Important When a battery in the battery is fully charged, a green light on the battery charger will glow to indicate that the battery is ready for use. AA5348 2012-12-20 2 7
DRX1System CAERSTREAM DRX1System DRX1System CAERSTREAM DRX1System DRX1System CAERSTREAM DRX1System DRX1System CAERSTREAM DRX1System Detector Operation Position the DRX-1 and DRX-1C System Detectors in a Bucky For the DRX-1 and DRX-1C System Detectors Only For optimum performance, it is important to position the detector properly in a Bucky when performing an exam. To provide a visual guide for positioning, the Service representative places a set of two positioning labels on each Bucky when the system is installed. These labels indicate detector orientation for portrait and landscape exams. To orient the detector properly, hold the detector so that the position of the ID label on the detector matches the position of the orientation label on the portrait or landscape label on the Bucky. Figure 7: Positioning Labels CAERSTREAM DRX1System H224_0042AA Figure 8: Detector Positioning Label H224_0043AA 2 8 AA5348 2012-12-20
Detector Operation Figure 9: Labels Applied to a Table Bucky H224_0044AA Figure 10: Detector Positioned on a Tabletop detector table bucky H230_1601BC Note The DRX 2530C Detector can be positioned on a tabletop as illustrated above. For best image quality, move the table Bucky to one side of the drawer and place the detector on the tabletop on the opposite side of the table. This places the detector away from any part of the table that generates noise. AA5348 2012-12-20 2 9
Detector Operation Using Detectors Using a Single Detector A single detector may be placed in on a tabletop, in a wheel chair, and so forth. Typically, the detector is registered with the Console for a particular room, but you can register it with other Consoles in other rooms as well, or use it with mobile systems. To avoid confusion, name the detector the same name as its icon, and add a description to identify its location. See Registering a Detector in the CARESTREAM DRX-1 System Online Help. Using Two or More Detectors in One Room Using two or more detectors in a room makes detector identification even more important. Make sure that the label on the detector matches the icon displayed on the Console. Before exposing the patient, you must read the barcode on the detector with the barcode scanner when moving the detector to a new room. Using Detectors in Two or More Rooms The identification labels make it easy to prevent the mixing of detectors from one room to another. Keep a different color scheme for each room and then subsequent detectors can be assigned labels within that color. You can register the same detector on two consoles. For example, you may use one detector as a float detector. The System is designed so that if the Console cannot communicate with the selected detector, the X-ray generator will not start. The workflow is the same. See the CARESTREAM DRX-1 System Online Help for information about workflow. 2 10 AA5348 2012-12-20
Detector Operation Tether Operation There are two models of tether interface available: the DRX-TPC1 Tether Interface, designed to be used with exams that require the detector to come in contact with the patient, and the CARESTREAM DRX-1 System Tether Interface, which is not used when a patient must come in contact with the detector during an exam. See Figure 12, Patient Vicinity. It shows a diagram of the distance and boundaries for medical and non-medical equipment as they relate to the patient. DRX-1 System Tether Interface Caution Do not allow the detector to come in direct contact with a patient while in Tether mode when using the DRX-1 System Tether Interface. Use this tether to connect the detector to the system when: The detector is located inside a Bucky (DRX-1 and DRX-1C System Detectors only) or other device that prevents direct patient contact The detector is not being used for an exam DRX-TPC1 Tether Interface Caution Only the model DRX-TPC1 Tether Interface may be connected to a detector that will come in contact with the patient. The DRX-TPC1 Tether Interface may be identified as follows: Blue wrapping on the tether cable Plastic tether box enclosure Round plastic tether cable connector Class II mark on the DRX-1 System Tether Interface Data Plate label Note For more information about the tethers, see the CARESTREAM DRX-1 System User Guide.. AA5348 2012-12-20 2 11
Detector Operation Figure 11: Patient Vicinity 1.83 m (6.00 ft) 2.5 m (8.0 ft) 1.83 m (6.00 ft) 1.83 m (6.00 ft) H196_0004GC Caution Keep all electronic devices (wireless or hard wired) three feet from the detector when in use. 2 12 AA5348 2012-12-20
Detector Operation Connect the Tether To connect the detector with a tether, remove the detector tether connection cover. Place the metal end of the tether on the magnetic bar on the side of the detector. If the tether is connected correctly, it will not interfere with the position of the detector. Figure 12: Connecting a Tether H224_0029GC Labeling the Detector for Use Labels are grouped by color and number series so that you can keep the same identification scheme in each room. To avoid confusion, make sure the label you choose is not already in the System. Apply the Label 1. Place the detector on a flat surface with the Tube Side facing you. 2. Position the detector label you have selected inside the Tube Side label. AA5348 2012-12-20 2 13
Detector Operation DRX Detector LED Display Matrix LED Pattern The meaning of the LED Pattern. The action the user should take. 1 Green Flash The detector is in Standby, and no study is active. The Console may not be connected, or the power is low. 2 Green Flashes The System is on, and in Ready status. 3 Green Flashes The System is on and enabled, but not ready. 4 Green Flashes The System is on and enabled. These flashes appear while pressing the prep switch. 5 Green Flashes A power fault has occurred. The detector is unusable. 1 Blue Flash The detector is currently connected to the System Console. 2 Blue Flashes The detector is not currently connected to the System Console. 3 Blue Flashes The detector has rebooted and has not yet connected to the System Console. 4 Blue Flashes The detector is performing a firmware upload. 5 Blue Flashes The detector is attempting to connect to the wireless Access Point (AP). No action is required. The detector is not being used. No action is required. The LED indicates that the detector has been selected. This should not display in normal operation. If this pattern is visible, call Service. No action is required. Remove and re-insert the battery to clear the problem. If the problem persists, call Service. No action is required. If this pattern occurs while detector is in use, call Service. If this pattern occurs when the detector should be in use, call Service. Do not interact with the detector. No action is required. 2 14 AA5348 2012-12-20
Detector Operation Disposal In the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to appropriate facilities for recovery and recycling. Contact your local representative or refer to http://recycle.carestreamhealth.com for additional information on the collection and recovery programs available for this product. Transport and Storage Environment Temperature Relative Humidity Altitude 23 to 66 C ( 10 to 150 F) 10 to 86 % RH Maximum Altitude 3658 m Operational Environment Temperature Relative Humidity Altitude 15 to 30 C (59 to 86 F) 10 to 86 % RH Maximum Altitude 3000 m AA5348 2012-12-20 2 15
Detector Operation Equipment Maintenance Cautions Caution Do not operate the equipment when cleaning the equipment. Do not immerse the equipment in liquid. Do not spray cleaning solution directly onto the equipment. Caution Isopropyl alcohol is a flammable solvent. Read and follow instructions in the Material Safety Data Sheet (MSDS). Procedure to clean the detector Prerequisites: 70 % Isopropyl alcohol solution Clean, soft cloth 1. Disconnect the detector from its power source. a. Remove the tether. b. Remove the battery. 2. Moisten a cloth with a 70 % isopropyl alcohol solution. 3. Apply the moistened cloth to the equipment. Postrequisites: Make sure the detector is dry before using it. 2 16 AA5348 2012-12-20
Detector Operation Procedure to clean the battery footprint 1. Wipe the well in the detector clean of dust or debris with a soft cloth. 2. Use a soft brush or vacuum to clean out the prongs in the battery compartment well, or contact Service for assistance. Prongs in the Battery Compartment Well H224_0045BC Patient Contact With each occurrence of patient contact: 1. Moisten a cloth with a 70 % isopropyl solution. 2. Apply the solution to the patient contact area. Caution Do not spray solution directly onto the equipment. Moisten a cloth with a 70 % solution of isopropyl alcohol solution and apply to the patient contact areas after each occurrence. Caution Isopropyl alcohol is a flammable solvent. Read and follow instructions in the Material Safety Data Sheet (MSDS). Note If a detector is not used in a Bucky, it is enclosed in a protective plastic bag that is disposed of after each patient exam. AA5348 2012-12-20 2 17
Detector Operation Shipping and Handling Labels The following graphic is applied to the shipping package, and describes the conditions that should be met while the package is in transit and storage. It is shown for reference only. The actual shipping label may vary slightly. Figure 13: Shipping label Figure 14: Detector Weight Limit Label Caution Since the detector is not a patient support device, it must be placed on a suitable surface, such as a table or floor, before applying patient weight to it. The weight label indicates acceptable limits of use that will not damage the detector. To prolong the life of the detector, and minimize potential internal detector damage, observe the following weight restrictions: The maximum concentrated weight over a small area of the detector surface (50 mm (2 in.)) in diameter must not exceed 114 kg (250 lb). The maximum distributed weight applied uniformly over the entire detector surface is 170 kg (375 lb). 2 18 AA5348 2012-12-20
Detector Operation Publication History Revision Date Change A 2012-12-20 Initial Release AA5348 2012-12-20 2 19
Detector Operation 2 20 AA5348 2012-12-20
Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 United States Carestream Health, Inc., 2012 Printed in the United States CARESTREAM and DRX-1 are trademarks of Carestream Health. Pub No. AA5348 Rev A