Related Manuals for Mindray MR6501
Summary of Contents for Mindray MR6501
- Page 1 Internal Defibrillation Paddles Instructions for Use Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Page 3 Human factors refer to unin- tentional falling, intentional damaging, etc. In the event that it becomes necessary to return a unit to Mindray, please contact the Mindray Service Department and obtain a Mindray Customer Service Autho- rization Number.
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Page 4: Product Information
Caution z Choose the appropriate model based on size of the paddles and the practical situation of the patient. z The MR6501 paddles does not comply with IEC 60601-2-4 for surface area recommendations for defibrillation paddles. Warnings The internal paddles shall only be used by trained clinical professionals and with Mindray BeneHeart series defibrillator/monitors. -
Page 5: Visual Check
INTERNAL PADDLES INSTRUCTIONS FOR USE Warnings z If any of the following conditions is found, remove the internal paddles from use immediately ˆ The sterile package of the paddles is damaged. ˆ Paddle electrodes are scratched, pitted, or chipped conductive surfaces are bubbled, scratched, or chipped coating. -
Page 6: Using Internal Paddles
INTERNAL PADDLES INSTRUCTIONS FOR USE Caution z Never short the paddle electrodes in any conditions other than function check. Using Internal Paddles Make sure the preparation is finished as directed above. 2. Select energy by pressing the [Energy Select] key on the equipment’s front panel. -
Page 7: Cleaning, Disinfection And Sterilization
INTERNAL PADDLES INSTRUCTIONS FOR USE Note z When internal paddles are used for defibrillation, the energy selection is auto- matically limited to 50 joules because of possible cardiac damage from higher energies. Cleaning, disinfection and Sterilization Clean and sterilize the internal paddles after each use. Do not allow the insulating handles or paddle electrodes to dry after use and before cleaning. -
Page 8: Continuity Check
INTERNAL PADDLES INSTRUCTIONS FOR USE Continuity Check To ensure quality operation of the internal paddles, perform the following test ev- ery three months of normal use. To Perform the test, follow this procedure: Remove the internal paddles from the defibrillator. Use a volt/ohm meter or a digital multimeter to verify the resistance between the test points in the following table. -
Page 9: Operation And Storage Environment
INTERNAL PADDLES INSTRUCTIONS FOR USE Symbols Refer to instruction manual/ booklet DEFIBRILLATION-PROOF TYPE CF APPLIED PART Not made with natural rubber latex. Batch code Authorized representative in the European community Serial number Date of manufacture Manufacturer Federal law (USA) restricts this device to sale by or on the order of a Rx Only physician. - Page 10 INTERNAL PADDLES INSTRUCTIONS FOR USE Appendix Reprocessing Instructions Processing of resterilizable products according to din en ISO 17664:2004 Device: reusable internal paddles, comprising cables, connector, handles and spoons. Note: z Reusable internal paddles including three different types which are with coated spoons of 1-inch, 2-inch and 3-inch diameters respectively.
- Page 11 INTERNAL PADDLES INSTRUCTIONS FOR USE Instructions Remove contamination from surface immediately after use with soft paper/cloth; or, Rinse the product with running tap water (<40 ℃ ) for at least one minute until all visible residues are removed. Preparation at the point of use Note: z Do not use a fixating detergent or hot water (>40 ℃...
- Page 12 If other standard packaging material would be used, use the recommended method and parameters offered by the package supplier. Mindray has tested and approved internal paddles: 1-inch internal paddles, 2-inch internal paddles and 3-inch internal paddles for material compatibility and sterilization efficacy up to 50 cycles of moist heat sterilization, wrapped using the following parameters.
- Page 13 INTERNAL PADDLES INSTRUCTIONS FOR USE Store the product in a dry, clean, and dust-free environment at moderate temperature. Storage Store the packed internal paddles as directed by the instructions on the package. The following test instructions, materials and machines were used during the validation.
- Page 14 Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R. China Tel:+86 755 81888998 Fax:+86 755 26582680 E-mail: service@mindray.com.cn 1639 深圳迈瑞生物医疗电子股份有限公司 深圳市南山区高新技术产业园区科技南十二路 Shanghai International Holding Corp. GmbH (Europe) Eiffestraβe 80, 20537 Hamburg Germany 迈瑞大厦 邮编： 518057 24小时服务热线：...
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