5.Attachment 9 Safety Testing Report-2

Report No.：FM-CE-02-02      Version:      A/0 TEST  REPORT Product name:        Rollator                          Manufacturer Name:    DANYANG COMED HEALTHCARE CO.，LTD.                         Add:               No.3, BeiErHuan Road, Danyang City,  Jiangsu Province, China              Type of test:          Self Testing                       DANYANG COMED HEALTHCARE  CO.，LTD. Test report Product name Rollator Type CM401B quantity 1 Ref.documents ISO11199-2:2005 Manufactured date or SN 2011.10 Loading capacity 100kg Test conclusion According to ISO 11199-2 Walking aids manipulated by both arms－Requirements and test methods－Part 2: Rollators, the CM401Bwas tested, please see attacthment for the details. DANYANG COMED HEALTHCARE CO.，LTD. Date of issue: 2011.10.20 Remark For further details, please refer to the attachment.         Test by: Sun Chao Examined by: Wang Xiaoming Approved by: Yang Guangming Attachment of test report Clause Test item Result Dimen- sion Maximum permissible user mass 100Kg Diameter of tip N/A Maximum rollator height 36" Mimimum rollator height 31" Maximum rollator width 24" 4.1 The front wheel diameter ≥75mm 152mm Outdoor use≥180mm wheel width Out door use≥22mm 25.4 4.2 Stability Forward ≥15° 17.5° Backward ≥7.0° 9.1° Sideways ≥3.5° 4.6° 4.3 Running brake Max grip distance ≤ 75mm 65mm Move≤ 10mm in 1 min 6mm Parking brake Pushing force ≤60N 53N Pulling force ≤40N 30N Move≤ 10mm in 1 min 5mm 4.4 Handgrip 20 ≤The width ≤50 30mm Be securely fixed to the handle √ Be replaceable or easy the clean √ 4.6 Resting seat loading geometry and force 1200N, no part crack or break √ 4.7 Mechanical durability Handgrip static strength 1200N, record the height before and after √ 800N cyclic force, 200000cycles, shall no any cracks or fractures √ 4.8 Adjusting devices Shall be clearly marked √ 4.9 Folding mechanism When the walking aids is in the working position and inspected in accordance with 5.13, the folding mechanism shall stay securely locked, as judged by the inspector. √ 4.10 Adjustment of handles The handles may be adjustable but shall be securely fixed when in use √ On rollators having handles that may be angled or positioned so that they come outside the rollator and jeopardizes the stability of the rollator, either a physical stop shall prevent the unsale position or a warning showing the safe limits of adjustment for use shall explain the consequerces such and adjustment may have on the stability. √ 4.11 Materials and finish The rollator materials shall be cause discoloring of skin or clothing when the rollator is in normal use. √ All parts of the rollator shall be free from burrs, sharp edges or projections that could cause damage to clothing or discomfort to the user. √ 6.1 General The information applied to, and supplied with, rollators shall conform to the relevant part of EN 1041 together with, but not limited to, the following requirements. √ The information shall include advice on which other devices and/or types of devices that can be used in combination with the rollator in question, and any precaution of limitations needed to ensure user safety. √ 6.2 Information marked on the product and/or accessories Maximum user mass 100Kg Maximum safe working load to be marked on accessories √ Maximum allowed angle between the longitudinal centerline of the handle and the direction of motion, if the handles are sideways adjustable √ Manufacturer’s name or trade name and address √ Manufacturer’s model identification name and/or number √ Month and year of manufacture √ Maximum extension of the height adjustment, marked on the adjusting members. √ Maximum width of the rollator √ Whether or not the walking aids is designed for indoor or outdoor use. indoor use　 6.3 Documentation The following information shall be contained in the instructions for use and/or assembly, or clearly and indelibly marked on the product: ●Maximum rollator height. ●Minimum rollator height ●Maintenance and cleaning instructions, including a description of the method and suitable cleaning agents and any precautions needed to avoid corrosion and/or ageing of the materials used in construction of the rollator. ●Instructions for assembly, adjustment of all kinds, folding and unfolding. ●Warnings and advice about precautions relating to safe distances between moving and stationary parts. ●Maximum safe working load(SWL)for load carrying accessories such as basket, tray, shopping bag, etc. √ labeling Country of origin marking Shall indicate county of origin legibly, permanently, and in comparable size and close proximity to any mention of country other than country in which the article was manufactured or produced. Must be visible at point of purchase. √　 Use labeling Use instructions that are clear and understandable shall be provided in language appropriate to destination countries. √ Instruction manual Shall be provided if equipment requires assembly, instructions for multiple operations. Or warnings for safe operations, information concerning assembly, parts, operation, and maintenance shall be provided as specified. √ Certificate listing If applicable, shall include certificates indicated that: ●Prevention of burglary with EN electronical lock ●Certified of flammability test ●Limited lifetime warranty ●Prevention of burglary storage number ●Other accessories N/A √ √ N/A √           继续阅读