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Related Manuals for ROLENCE ENTERPRISE XR-01
Summary of Contents for ROLENCE ENTERPRISE XR-01
- Page 1 Portable X-ray System XR-01 USER’S MANUAL Rolence Enterprise, Inc. No.18-3, Lane 231, Pu Chung Rd., Chungli, Taoyuan 32083, Taiwan TEL: +886-3 463-1999; FAX: +886-3 463-1997, www.rolence.com.tw; info@rolence.com.tw S-19-01-1500-U0001 V 1.5...
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Page 2: Table Of Contents
Table of Contents Table of Contents I. CERTIFICATE OF WARRANTY .............. 4 1.1 Range and terms for warranty ............... 4 1.2 Requirements on After service call ............4 1.3 Development Policy................4 II. GETTING STARTED .................. 5 2.1. Intended Use ..................5 2.2 Principle of Operation ................ - Page 3 Table of Contents V. COMPOSITION..................16 5.1 Composition ..................16 5.2 AC/DC adaptor for recharging.............. 16 5.3 Battery....................17 VI. EXPLANATION OF EACH PART .............19 6.1 Main Dislpay and Control Panel............20 VII. OPERATION..................21 7.1 Power On .................... 21 7.2 Adjustment of Exposure time ...............
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Page 4: Certificate Of Warranty
Certificate of Warranty I. CERTIFICATE OF WARRANTY 1.1 Range and terms for warranty Rolence guarantee this product without any expense for the malfunction or disorders occurred under standard transportation and operation within 1year from installation. 1.2 Requirements on After service call When the malfunction or disorder appeared, stop operating and check again the related article of this “User’s Manual”. -
Page 5: Getting Started
II. GETTING STARTED 2.1 Intended Use The XR-01 Portable X-Ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both... -
Page 6: Cleaning
Getting Started 2.4 Cleaning Ensure the adaptor is unplugged before attempting to clean. To make sure that power is off while cleaning. Use a non-alcohol based disinfectant only - wipes or a cloth dampened with liquid or spray. The system is not designed to be subjected to any kind of sterilization procedure and not designed to be used to sterilize anything else. -
Page 7: Symbols
Getting Started 2.5 Symbols Symbols used in this publication and used mark on the equipment have the following meanings. Symbols Description Symbols Description X-Ray Source Assembly, Electrical Shock Emitting Hazard Warning; Radioactive material High Voltage or ionizing radiation Consult Accompanying Attention, Documents Consult Accompanying... -
Page 8: Safety
Safety III. SAFETY 3.1 Electrical Safety WARNING ! Electrical circuits inside the equipment use voltages which are capable of causing serious injury or death from electric shock. To avoid this hazard, operators should never remove any of the cabinet covers. Observe the following safety procedures to avoid electric shock or serious injury to operators and patients and to avoid system malfunction. -
Page 9: Electrical Fire
Safety 3.2 Electrical Fire The user should develop an emergency procedure for the area in which the system is used that includes the following safety measures: ● Turn the system off and unplug the main power cable from the outlet. ●... -
Page 10: Radiation Safety
Safety 3.4 Radiation Safety 3.4.1 General WARNING ! This x-ray unit may be dangerous to patient and operator unless safe exposure values are used and correct operating procedures are observed. This X-Ray tube assembly produces ionizing radiation when energized. Hence, when, used, it can be better that the authorized operators wear X-ray Protective devices like X-Ray protective apron, glove or thyroid cover, etc. - Page 11 Safety 3.4.2 Handheld Rolence XR-01 Portable X-Ray can be used handheld equipment; it is convenient for use anytime anywhere. 3.4.3 Significant zones of occupancy Please establish significant zone of occupancy as following and puts individual defense tool such as apron in this area and face in radiography.
- Page 12 Specified in 10 CFR 20.1201 and 10 CFR 20.1208 Leakage The inherent shielding of XR-01 was sufficient to eliminate leakage radiation. The measurement was performed at 10 mm from the device surface at 9 points as follows: (Unit: mGy/hour) 0.028...
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Page 13: Storage And Transportation Environment
Safety 3.5 Storage and Transportation Environment Avoid the following environments for storage or transportation; ● Where the equipment is exposed to water vapor. ● Where the equipment is exposed to direct sunlight. ● Where the equipment is exposed to dust. ●... -
Page 14: Precaution
Precaution IV. PRECAUTION NOTE ! The system should be used only by personnel possessing relevant qualifications, including adequate training in radiation protection. NOTE ! Radiation safety training requirements vary from country to country. Please consult with your local Radiation/Health authority for more details. NOTE ! Read carefully the following this manual. -
Page 15: Caution When User Starts To Use
3. Before turning Power on, check whether battery should be fully charge. NOTE ! Remove the power cord before using, XR-01 is not functional while charging. 4.3 Checking Before Operating 1. Observe carefully on the whole system and the patient. -
Page 16: Composition
- Manufacturer : Mean Well Enterprises Co., Ltd. - Rated Input : 100-240Vac, 50-60Hz, 1.4-0.7A - Rated output : 24Vdc/2.5A, 60W MAX WARNING ! Recharge with the recharge unit supplied by Rolence. Use it only for the XR-01, otherwise it may occur malfunction or disorder. S-19-01-1500-U0001 V1.5... -
Page 17: Battery
Use the battery supplied by Rolence. The user is responsible for any malfunction from usage with another battery. - Model Name : 7S1PXRP001(Li-Polymer Type) - Manufacturer : Rolence Enterprise Inc. - Voltage : 25.2Vdc - Capacity : 2900mAh - Recharge Battery -... - Page 18 Composition 1. Assemble Power Cord and Adapter then charge directly. 2. If powered, the LED indicator light on with green. 3. The LED indicator shows orange light if recharging. 4. The LED indicator shows green light if recharge complete. S-19-01-1500-U0001 V1.5...
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Page 19: Explanation Of Each Part
Explanation of each part VI. EXPLANATION OF EACH PART Power ON/OFF Switch X-ray Exposure Button Hand Switch Connector Main Display and Control Panel Battery Cover Beam Limiting Device S-19-01-1500-U0001 V1.5... -
Page 20: Main Dislpay And Control Panel
Explanation of each part 6.1 Main Display and Control Panel Main Display Ready Button and Indicator Light Battery Status Power Indicator Light Exposure Exposure Time Warning Light Setting Image Sensor: Patient: Child Phosphor Plate Patient: Adult Image Sensor: Digital Sensor Image Sensor: Film Quick Setting... -
Page 21: Operation
When power switched on, the XR-01 need 5sec to initiate. In initiate process main display shows 0.00 and the ready indicator lights on in orange, user is unable to control XR-01 until the ready indicator turns off and initiate complete. -
Page 22: Adjustment Of Exposure Time
Rolence. 7.2 Adjustment of Exposure time 7.2.1 The XR-01 has fixed tube voltage and tube current at 60 kV, 2.0 mA. Only exposure time is adjustable from 0.01-2 seconds. 7.2.2 Adjust exposure time by pressing Exposure Time Setting "up" button to increase, "down"... - Page 23 Operation 7.2.5 Pre-set exposure time Item Part Exposure Time Anterior 0.27 sec Adult Posterior 0.32 sec Bite Wings 0.34 sec Phosphor Plate Anterior 0.15 sec Posterior 0.26 sec Child* Bite Wings 0.27 sec Anterior 0.20 sec Posterior 0.27 sec Adult Bite Wings 0.29 sec Digital...
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Page 24: Exposure
3) Push “Ready" button to disable the safety lock. 4) “Ready indicator light” turns on in green. 5) If not start X-Ray exposure in 30sec, XR-01 goes back to safety lock mode and green ready light turns off. 6) Press down "X-Ray Exposure Button" continuously to start exposure process. -
Page 25: Battery Recharging And Operation Time
You should use its own adaptor supplied by Rolence. WARNING ! This battery is exclusive for XR-01. You cannot use any other battery for this equipment. When life span of battery is finished, you should change it with the same Battery supplied by Rolence. -
Page 26: Maintenance Plan
1. Review this user’s manual periodically to ensure operator’s understanding of intended use. 2. Routine clean of the XR-01 is essential. Use non-acetone base disinfectant to wipe the exterior surface of the XR-01. 3. A periodically review process of personnel training is essential to be established. -
Page 27: Maintenance Log Sheet
Date Power button Time selection buttons X-ray exposure button READY state Exposure termination Exposure warning signal Exposure termination Calibration check (if needs) *1 For ensuring XR-01 works properly, scheduling a five years inspection by Rolence is strongly recommended. S-19-01-1500-U0001 V1.5... -
Page 28: Help Message
Help message IX. HELP MESSAGE 9.1 Error Code If there’s any error happens on this equipment, it shows the following error code in order to clarify the problem. Error Class of Error Counter plan Code Low Battery Recharge Battery The battery power is insufficient to generate X-Ray Filament Fail The filament is broken... -
Page 29: Disposal
It must be disposed of according to local requirements. DO NOT dispose of any part of XR-01. Please contact with authorized representative or Rolence Enterprise Inc. for disposal or recycling. - Page 30 Type Round Type Source to Skin Distance 20cm X-ray field size Ø60 11.1.7 Battery Model Name 7S1PXRP001(Li-Polymer Type) Manufacturer Rolence Enterprise Inc. Nominal Voltage 25.2Vdc Capacity 2900mAh 11.1.8 AC/DC Adaptor Model Name GSM60A24-P1J Manufacturer Mean Well Enterprises Co., Ltd. Rated Input 100~240Vac, 50~60Hz, 1.4~0.7A...
- Page 31 Technical Data 11.1.9 Dimension(Unit : mm) and Weight 2.7kg±10% Main Body with 174 x 178 x 257 Beam Limiting Cone Main Body without 2.5 kg±10% 174 x 178 x 150 Beam Limiting Cone AC/DC Adaptor 121 x 48 x 30 280g±...
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Page 32: X-Ray Tube Specifications And Characteristics
Technical Data 11. 2 X-Ray Tube Specifications and Characteristics (1) Manufacturer Canon(D-045) (2) Type Stationary (3) Focal Spot 0.4mm (4) Target Angle 12.5° (5) Target Material Tungsten (6) Inherent Filtration 1 mmAl (7) Cooling Method Oil cooling (8) Input Energy(see rating chart) 585W(at 1.0s) (9) Maximum Tube Voltage 70kV... - Page 33 (15) Rating chart S-19-01-1500-U0001 V1.5...
- Page 34 S-19-01-1500-U0001 V1.5...
- Page 35 (16) Dimensional Outline of X-ray Tube (D-045) S-19-01-1500-U0001 V1.5...
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Page 36: Wiring Diagram
REMOTE S/W PACK *OPTION CONTROL BOARD CN1-M CON2 BATTERY S/W CN1-F CON2 RECHARGE UNIT 110-240V AC 90-270V 50/60 Hz 24V 1A DC AC ADAPTOR 24V 9.2A DC NOTE ： Recharge unit can not connect to XR-01 x-ray unit S-19-01-1500-U0001 V1.5... -
Page 37: Emc Test Report
11.4 EMC Test Report S-19-01-1500-U0001 V1.5... - Page 38 The equipment complies with the requirements in the Medical Device Directive 93/42/EEC. 1434 Rolence Enterprise Inc. No.18-3, Lane 231, Pu Chung Rd., Chungli, Taoyuan Taiwan 32083 Phone: +886-3 463-1999 FAX: +886-3 463-1997, www.rolence.com.tw info@rolence.com.tw CMC Medical Devices & Drugs S.L.
- Page 39 ANNEX I Guidance and manufacturer’s declaration-electromagnetic emissions The XR-01 is intended for use in the electromagnetic environment specified below. The customer or the user of the XR-01 should assure that it is used in such an environment. Emission test Compliance...
- Page 40 UT) for 5 s Power frequency 3 A/m 3 A/m The XR-01 contains no magnetic field devices susceptible to EN 61000-4-8 magnetic fields. NOTE UT is the a.c. mains voltage prior to application of the test level.
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