CARESTREAM DRX-1 System Safety and Regulatory Information with Hardware User’s Guide estr Car eam eam estr Car DR X1 Sys tem H224_0028HC Version 3.
Table of Contents 1 Safety and Regulatory Information Document Conventions ....................................................................................................................................1-1 Intended Use and Indications for Use...............................................................................................................1-1 Safety and Related Information........................................................................................................................
Table of Contents Cautions ...........................................................................................................................................................2-3 Installing the Hardware....................................................................................................................................2-3 Attaching Accessories.................................................................................................................................
1 Safety and Regulatory Information 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.
Safety and Regulatory Information Safety and Related Information Medical Equipment Classification CARESTREAM DRX-1 System Detector Medical Electrical Equipment Classification Type of protection against electrical shock: Internally powered equipment. Class I Equipment. Degree of protection against electrical shock: Type B Applied Part. Degree of protection against ingress of wa- Ordinary protection. ter: Mode of operation: Continuous operation.
Safety and Regulatory Information The CARESTREAM DRX-1 System includes the following components: CARESTREAM DRX-1 System Detector (one or more) CARESTREAM DRX-1 System Battery (any quantity) CARESTREAM DRX-1 System Battery Charger CARESTREAM DRX-1 System Tether Interface CARESTREAM DRX-1 System Console CARESTREAM DRX-1 System Access Point CARESTREAM DRX-1 System Medical Electrical Equipment Classification Type of protection against electrical shock: Internally powered equipment. Class I Equipment.
Safety and Regulatory Information The DRX-1 System uses an existing exposure switch connector on the X-ray equipment. No modification to the X-ray equipment is required. The intended use of the X-ray equipment is not affected and the X-ray equipment remains certified by the X-ray equipment manufacturer. Model-specific documentation and cables are provided to allow service personnel to connect and run functional testing on the DRX-1 System.
Safety and Regulatory Information The following Product Safety Standards apply to the CARESTREAM DRX-1 System. The DRX-1 System includes the following: CARESTREAM DRX-1 System Detector (one or more) CARESTREAM DRX-1 System Battery (any quantity) CARESTREAM DRX-1 System Battery Charger CARESTREAM DRX-1 System Tether Interface CARESTREAM DRX-1 System Console CARESTREAM DRX-1 System Wireless Access Point USA UL 60601-1:2003 - Medical Electrical Equipment, 1st Edition Canada CAN/CSA-C22.2 No. 601.
Safety and Regulatory Information The following Product Safety Standards are applicable to the CARESTREAM DRX-1 System Battery. USA UL 60601-1:2003 - Medical Electrical Equipment, 1st Edition Canada CAN/CSA-C22.2 No. 601.1-M90 (R2001) Medical Electrical Equipment CAN/CSA-C22.2 No. 601.1S1-94 (R1999) - Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 CAN/CSA-C22.2 No. 601.1B-90 (R2002) - Amendment 2 to CAN/CSA-C22.2 No. 601.
Safety and Regulatory Information EMC Standards for Detector and System IEC 60601-1-2:2004 includes EMC requirements and tests, Medical Electrical Equipment including CISPR 11:1999+A2:02, Group 1, Class A. This device complies with part 15 of the FCC Rules. Operation 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.
Safety and Regulatory Information Communications Equipment Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment EMC performance. The wireless version of the Carestream DRX-1 System Detector operates with the 802.11n protocol in the 5 GHz frequency band. The radio output power is 50 mW (nominal).
Safety and Regulatory Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The CARESTREAM DRX-1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the CARESTREAM DRX-1 System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 1 The CARESTREAM DRX-1 System uses RF energy only for its internal function.
Safety and Regulatory Information Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-1-2:2004 The CARESTREAM DRX-1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the CARESTREAM DRX-1 System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Electrostatic Discharge (ESD) +/- 6 kV contact +/- 6 kV contact Floors should be wood, concrete or ceramic tile.
Safety and Regulatory Information Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CARESTREAM DRX-1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the CARESTREAM DRX-1 System should assure that it is used in such an environment.
Safety and Regulatory Information Guidance and Manufacturer’s Declaration - Electromagnetic Immunity a Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Safety and Regulatory Information DRX-1 System Product Information DRX-1 System Detector CARESTREAM DRX-1 System Detector Tube Side H224_0053AA < 23 Kg < 50 Lb < 125 Kg < 275 Lb Tube Side H224_0052GA H224_0054GA Detector Size 38 x 46 x 1.6 cm Detector Image Area 35 x 43 cm Detector Weight 4 kg (8.5 lb) Detector Weight-Applied Limit Applied to a single 5 cm (2 in.
Safety and Regulatory Information DRX-1 System Battery Charger NOTE: For complete information on the CARESTREAM DRX-1 System Battery Charger, see the CARESTREAM DRX-1 Battery Charger User’s Guide. CARESTREAM DRX-1 System Battery Charger m DRX1 System Carestrea am Carestre Carestream Carestream DRX1 System H223_0004BA Size 38 x 14 x 18 cm Weight 2.26 kg (5 lb) Electrical Ratings 100-240Vac, 50/60 Hz, 1.0A Power Output: 12 V to 16.
Safety and Regulatory Information DRX-1 System Battery NOTE: For complete information on the care and handling of the DRX-1 System Battery, see the CARESTREAM DRX-1 System Battery User’s Guide. Size 21 x 15 x 0.5 cm Weight 0.4 kg (12.4 oz) Electrical Ratings 14.8V dc, 2.1Ah (nominal) capacity CAUTION: The System console is not medical electrical equipment and should not be placed in the patient vicinity. See “Patient Vicinity” on page 1-18.
Safety and Regulatory Information DRX-1 System Wireless Access Point See CISCO Wireless Access Point User Guide for Specifications. Electrical Ratings 100-240V ac 50/60 Hz CAUTION: The System Wireless Access Point is not medical electrical equipment and should not be placed in the patient vicinity. See “Patient Vicinity” on page 1-18. DRX-1 System Tether Interface Size 16 x 24 x 7 cm Weight 02.3 kg (5 lb) Electrical Ratings 100-240V ac, 0.
Safety and Regulatory Information Patient Vicinity 1.83 m (6 ft) 2.5 m (8 ft) 1.83 m (6 ft) 1.83 m (6 ft) H196_0004GC CAUTION: The System Console, Battery Charger, Network Switch, and Wireless Access Point are not medical electrical equipment and should not be placed in the patient vicinity. CAUTION: Keep all electronic devices (wireless or hardwired) three feet from the detector when in use.
Safety and Regulatory Information Labels 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.
Safety and Regulatory Information DRX-1 Battery Dataplate Label 7H8166 1-19
Safety and Regulatory Information DRX-1 System Detector Dataplate Label System Console Label 1-20 7H8166
Safety and Regulatory Information System Tether Interface System Label 7H8166 1-21
Safety and Regulatory Information Detector Labeling Battery H224_0053AA Tube Side H224_0054GA < 23 Kg < 50 Lb < 125 Kg < 275 Lb Tube Side H224_0052GA Weight Label 1-22 7H8166 ID Label
Safety and Regulatory Information Disposal Information 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.
General Contact Information Carestream Health, Inc.
2 Hardware and Operation Overview The CARESTREAM DRX-1 System lets you connect a digital DR Detector to an analog system and capture images digitally. Use the existing analog console to set up the exam and determine the technique. Then, expose the subject with the DRX -1 System and view and manipulate the image on the computer using Image Viewing Acquisition Software. You can send the image to destinations such as workstations via an Ethernet connection.
Hardware and Operation CARESTREAM DRX-1 System 햴 햲 햺 햵 햳 햶 햹 햸 estr Car eam eam estr Car DR X1 Sys tem 햷 1. DRX-1 System Detector—Captures radiographic images of human 2. 3. 4. 5. 6. 7. 8. 9. 2-2 anatomy for display. Console—Controls and records all responses in the imaging process. Monitor—Lets you view the Image Viewer Screen and DIRECTVIEW Software. Keyboard—Lets you access the Image Viewer Screen and DIRECTVIEW Software. Mouse—Lets you access the Image Viewer Screen and DIRECTVIEW Software.
Hardware and Operation Cautions CAUTION: For continued safe use of this equipment, follow the instructions contained in this operating manual. CAUTION: Study this manual carefully before using the equipment and keep it at hand for quick reference. CAUTION: The system must be used only by qualified personnel and only after training in the specific operations.
Hardware and Operation Attaching Accessories The use of equipment and/or hardware that does not comply with the equivalent product safety and EMC requirements of this product may lead to a reduced level of safety and/or EMC performance of the resulting system. Consideration relating to the choice of accessory equipment used with this product shall include: • Use of the accessory in the patient’s vicinity.
Hardware and Operation NOTE: In the event of an aborted exposure, the detector acquires the image and processes it normally. This may result in less than optimal image quality. Exposure Time: The CARESTREAM DRX-1 System Detector can acquire images from exposures of up to 1 second. CARESTREAM DRX-1 System Battery CAUTION: To assure proper operation, use only the CARESTREAM DRX-1 System Battery.
Hardware and Operation Installing the Battery H224_0016AC 2. Push the battery firmly down until the latch catches. NOTE: See the CARESTREAM DRX-1 System Battery Charger User Guide for information on the battery and charger use, specifications, and disposal. Removing the Battery Place a tool such as a ball-point pen in the release slot and push down on the latch. The battery releases and pops up for easy removal.
Hardware and Operation Labeling the Detector The labels that come with the detector help you: 1. Uniquely identify the detector. 2. Orient the detector correctly in use. Go to Key Operator Functions > Equipment Management to view the selections of DRX-1 labels to choose from. Labels are grouped by colors and number series so that you can keep the same scheme in each room. Make sure the label you choose is not already in the system. Applying the label: 1.
Hardware and Operation Label LED H224_0019AC LED Pattern Meaning 1 Green Flash Detector is in Standby, no study is active; No action required. Detector is not being Console may not be connected. Low used. Power. 2 Green Flashes System is on, and Ready. 3 Green Flashes System is on and enabled, but not ready. Should not display in normal operation. If this pattern is visible, call Service.
Hardware and Operation Positioning the Detector in the Bucky For optimum performance, it is important to position the detector properly in the Wall Stand Bucky or the Table Bucky when performing an exam. To provide a visual guide for positioning, Service places a set of two positioning labels on each Bucky at installation to indicate how to orient the detector for portrait and landscape exams.
Hardware and Operation Example of Labels Applied to Table Bucky Positioning Labels Positioning the Detector on a Tabletop If you are not using a Bucky, for best image quality, place the detector on the table top away from any part of the table that generates noise. To do this, move the Table Bucky to one side of the drawer and place the detector on the tabletop on the opposite side of the table.
Hardware and Operation Using Two or More Detectors 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 on the Console before exposing the patient. You must use the bar-code scanner while on the screen to read the bar-code on the detector when moving the detector to a new room. IMPORTANT: The system does not automatically select a detector. Supervise carefully to make sure that the correct detector is selected.
Hardware and Operation Using Detectors in Two or More Rooms The identification labels make it easy to prevent 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.
Hardware and Operation Tether Operation The primary function of the tether is to provide power and communications to the detector while it is positioned in a Bucky. CAUTION: Do not allow the detector to come in direct contact with a patient while in tether mode. The DRX-1 System Detector should be connected to the DRS-1 System Tether Interface when: • The detector is located outside the patient vicinity. • The detector is not being used for an exam.
Hardware and Operation Tether Connection On Detector NOTE: The detector will function properly with a non-charged battery installed when the tether is properly connected and operating. It is not necessary to remove the battery to recharge it if the battery has not reached end of life and can be re-charged. NOTE: With a charged battery in place, image acquisition continues if there is a loss of tether connection. NOTE: Additional tethers are available to replace damaged cables.
Hardware and Operation CAUTION: Isopropyl alcohol is a flammable solvent. Read and follow instructions in the Material Safety Data Sheet (MSDS). CAUTION: Do not immerse the equipment in liquid. To clean the detector: 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. To clean the battery footprint: 1. Wipe the well clean of dust or debris with a soft cloth.
• Apply to the patient contact areas. CAUTION: Isopropyl alcohol is a flammable solvent. Read and follow instructions in the Material Safety Data Sheet (MSDS). System Maintenance CAUTION: Do not attempt mechanical or electrical repair of the CARESTREAM DRX-1 System. Contact your Service representative if any unit does not perform to your satisfaction. The CARESTREAM DRX-1 System must be maintained in good operating order at all times to provide safe conditions for operating personnel and patients.
Hardware and Operation • No cables have abrasions or damage, particularly in locations where cables are draped and subject to stress. Grid Recommendation Artifacts are not visible when the following grids are used. • 103 line pair/inch low frequency stationary grid Protective Enclosures When there is a risk of fluids contacting the detector, place the detector in a protective bag.
Index Numerics 1 blue flash, 2-8 1 green flash, 2-8 2 blue flashes, 2-8 2 green flashes, 2-8 3 blue flashes, 2-8 3 green flashes, 2-8 4 green flashes, 2-8 5 green flashes, 2-8 using two or more, 2-11 using two or more rooms, 2-12 weight limit, 1-19 wireless operation, 2-12 detector calibrations, 2-16 detector LED, 2-7 disposal information, 1-24 do not submerge components, 2-3 download from the RIS, 2-1 A accessories, attaching, 2-3 analog system, 2-1 authorized service personnel, 2-3 E equipment integrit
Index P patient contact, 2-15 perform periodic maintenance, 2-3 protective enclosures, 2-17 R radiographer, 2-1 repairing the detector, 2-16 S spraying cleaning solution, 2-14 System, 2-2 system console label, 1-21 system overview, 2-1 T tether, 2-1 removed during the exam, 2-14 removing, 2-13 replacement, 2-14 tether interface label, 1-22 traditional film, 2-1 turning the system off, 2-4 turning the system on, 2-4 U using film or CR system, 2-1 W weight label, 1-19 weight limit, detector, 1-19 wireless op
Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 CARESTREAM is a trademark of Carestream Health, Inc. © Carestream Health, Inc. 2008.
