MEDICAL DEVICE DIRECTIVE TECHNICAL FILE (CE COMPLIANCE) PERSONAL DIABETIC COOLER PACKS

Transcription

1 MEDICAL DEVICE DIRECTIVE TECHNICAL FILE (CE COMPLIANCE) PERSONAL DIABETIC COOLER PACKS Name of Manufacturer: International Haotian Technology Co. Ltd. Address: 602 Innovation Building Innovation Garden Huli District, Xiamen, Fujian , CHINA Authorized Representative in the EC: Cool IceBox Company Ltd. 27 Broad Street, South Molton, Devon, EX36 3AQ, U.K. Ms. Tina Evans Contact: ; Type of Product: Low temperature holding pack for Insulin, syringes, or Insulin Pen Systems Product Name: Personal Diabetic Cooler Pack Product Number: YBH-2011 (Cooler Bag-Insupen) YBH-2113 YBH-2517 YBH-2517B YBH-3223 General Description YBH-2011, YBH-2113, YBH-2517, YBH-2517B and YB-3223 are insulated personal size packs designed to hold Insulin safely at ready-use temperatures. Cooling is supplied by sealed pre-frozen HTIceGel and HTIceBrick units (MSDS attached). The Product, being in the terms of Medical Directive 93/42/EEC (a) A Medical Device defined in accordance with Article 1, 2(a) as an apparatus or other article, whether used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of: -prevention, treatment or alleviation of disease and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic 1 of 16

2 (b) (c) means; an inactive medical device for non-invasive short term use; an accessory intended specifically by the manufacturer to be used for a temporary containment or storage function; meets the Classification Criteria for Class 1 in Annex IX of the Directive. YBH-2011, YBH-2113, YBH-2517, YBH-2517B and YBH-3223 are low temperature holding packs for Insulin and designed specifically by the manufacturer to be used principally as a stand alone temporary containment or storage function within safe temperature limits for the contents while in transit or during use, for: Insulin for human beings for the purpose of the treatment or alleviation of Diabetes Type 1 and 2; and Syringes, disposable Insulin Pen Systems and Blood Glucose Monitor. Product Specification YBH2011 (Cooler Bag-Insupen) Usable Cold Space Dimensions 190*100*35 mm Example of Contents (NOT supplied) Insulin - 3*10 ml vials Disposable Insulin Pen Systems - 2 Syringes - 3 Blood Glucose Monitor - 1 Storage Method Net Pocket (zipped), Elastic webbing storage loops Empty Weight 130 gm Empty Weight (incl. HTIceGel) 230 gm External Dimensions 200*110*45 mm External Surface Ethylene Vinyl Acetate (EVA) Internal 420 Denier Nylon Insulation PE closed cell foam mm (k = oC) Lid Type Sealed hinge and zip fastener, with inner lip to reduce cold losses Refrigeration Pack 1 off HTIceGel Pack, HTI-19 Digital Thermometer Recommended Option HTIceGel Pack Dimensions 190*80*10 mm HTIceGel Pack Weight 100 gms/pc Shipping Carton Dimensions 42*42*58cm Pieces/Carton 100pcs o Cold Life at 35 C ambient 3 to 5 hrs. (2-10oC) 2 of 16

3 YBH-2011 (Cooler Bag-Insupen) 1.2 Product Specification YBH-2113 Usable Cold Space Dimensions 200*120*70mm Example of Contents (NOT supplied) Insulin - 5*10 ml vials Disposable Insulin Pen Systems - 4 Syringes - 6 Blood Glucose Monitor - 1 Storage Method Net Pocket (zipped), Elastic webbing storage loops Empty Weight 205 gm Empty Weight (incl. HTIceGel) 505 gm External Dimensions 210*130*80 mm External Surface Ethylene Vinyl Acetate (EVA) Internal Poly Vinyl Chloride (PVC) Denier Nylon Insulation PE closed cell foam mm (k =.076 0oC) Lid Type Sealed hinge and zip fastener, with inner lip to reduce cold losses Refrigeration Pack 2 off HTIceGel Pack, HTI-21 Digital Thermometer Recommended Option HTIceGel Pack Dimensions 210*80*15 mm HTIceGel Pack Weight 150 gms/pc Shipping Carton Dimensions Pieces/Carton 51*45*48 cm 48pcs Cold Life at 35o C ambient Up to 12 hrs. (2-10oC). 3 of 16

4 YBH Product Specification YBH-2517 Usable Cold Space Dimensions 240*160*95 mm Example of Contents (NOT supplied) Insulin - 5*10 ml vials Disposable Insulin Pen Systems - 4 Syringes - 6 Blood Glucose Monitor - 1 Storage Method Net Pocket (zipped), Elastic webbing storage loops Empty Weight 280gm Empty Weight (incl. HTIceGel) 1.92kg External Dimensions 250*170*105 mm External Surface Ethylene Vinyl Acetate (EVA) Internal Poly Vinyl Chloride (PVC) Denier Nylon Insulation PE close cell foam mm (k = oC) Lid Type Sealed hinge and zip fastener, with inner lip to reduce cold losses Refrigeration Pack 2 of HTIce Brick, HTBh-250 Digital Thermometer Recommended Option HTIceGel Pack Dimensions 250*145*40 mm HTIceGel Pack Weight 820 gms/pc Shipping Carton Dimensions Pieces/Carton 55*38*46cm 20pcs Cold Life at 35o C ambient Up to 24 hrs. (2-10oC) 4 of 16

5 YBH Product Specification YBH 3223 Usable Cold Space Dimensions 30*21*15cm Example of Contents (NOT supplied) Insulin - 10*10 ml vials Disposable Insulin Pen Systems - 8 Syringes - 10 Blood Glucose Monitor - 2 Storage Method for Contents Net Pocket (zipped), Elastic webbing storage loops Empty Weight 0.825kg Empty Weight (incl. HTIceGel) 1.71kg External Dimensions 320*230*160 mm External Surface Polyurethane (PU) Imitation Leather Body Moulding Ethylene Vinyl Acetate (EVA) Internal Lining Poly Vinyl Chloride (PVC) Insulation PE close cell foam - 5 mm (k = oC) Lid Type Sealed hinge and zip fastener, with inner lip to reduce cold losses Refrigeration Pack 2 pcs. x HTI-2820 IceGel Digital Thermometer Recommended Option HTIceGel Pack Dimensions 280*200*20 mm HTIceGel Pack Weight 540 gms/pc Shipping Carton Dimensions & Pieces/Carton 46*34*64cm/8pcs Cold Life at 35o C ambient Up to 24 hrs. (2-10oC) 5 of 16

6 YBH Key Points YBH-2011, YBH-2113, YBH-2517, YBH-2517B and YBH-3223 are designed by the manufacturer for safety, convenience and simplicity for diabetic sufferers. 2. The use of safe high performance HTIceGel as the cooling energy The thermoformed EVA outer case provides semi-rigid protection for the contents PE closed cell foam insulation properties and advanced HTIcegel ensure reliable cold life. Does not contain Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls (PBB), or Polybrominated Biphenyl Ethers (PBBE) The Thermal Insulation complies with the Montreal Protocol on the Elimination of Ozone Depleting Chemicals The top cover is closed using two zip fasteners that draw together two sealing lips minimizing cooling losses The top cover is fitted with a sealing EVA hinge that is capable of being opened beyond 90 o without damage A net pocket closed with a zip fastener and/or elastic webbing loops are used to firmly fix the contents in place to avoid damage. Method of Manufacture YBH-2011, YBH-2113, YBH-2517, YBH-2517B and YBH-3223 Typical Cross Sections of the thermoformed Personal Diabetic Pack, showing the insulation and the refrigerant in place. 6 of 16

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8 3. Method of Use Users are advised to carefully read the Instructions supplied with the Personal Diabetic Cooler Pack. 3.1 Preparations for Use Freeze the HTIceGel or HTIceBricks by placing in a freezer until fully frozen. Remove the HTIceGel or HTIceBricks from the freezer, and condition by leaving at ambient temperature until dew forms on the surface of the pack. Place the HTIceGel or HTIceBricks in the indicated positions inside the Personal Diabetic Cooler Pack. Place the necessary supplies in the net pocket and/or elastic webbing loops provided. Check the digital thermometer for battery condition, and place it inside 8 of 16

9 Instructions for Use the pack, if this option is supplied. Note the time, and that the temperature inside the pack is between 2 and 10 oc. Open the pack only when required, and for as short a time as possible on each occasion Outdoors: Keep the Personal Diabetic Cooler Pack out of direct sunlight. Indoors: Keep the Cooler Pack away from any source of high temperature. In the car: Do not place the Cooler Pack next to heaters or close to the engine compartment Never leave the Cooler Pack zipper open. Keep open for as short a time as possible. The Diabetic Cooler Pack is safe to be carried in other bags or boxes. Do not try to open the Ice Bricks or Ice Packs. Avoid damage to the Ice Bricks and Ice Packs from sharp edges or sharp implements. Do not eat the gel. Do not use Ice Bricks or Ice Packs that have been damaged. The gel contained in the Ice Bricks and Ice Packs is non-toxic and eco-friendly. Always discard unusable gel from damaged Ice Bricks or Ice Packs in accordance with the regulations for protecting the environment in your State or Country. Personal Diabetic Cooler Pack User Instructions supplied with each Personal Diabetic Cooler Pack (Two pages). See the following: 9 of 16

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12 4. Risk Analysis The European Standard EN 1441 Medical Devices Risk Analysis has been taken into account in the following risk analysis procedure: 4.1 Characteristics which could affect safety: a) b) c) d) e) 4.2 Direct contact by a frozen HTIceGel pack or HTIceBricks with the skin The HTIceGel packs may be breached allowing the contents to escape Unprotected needle tips The contents may be damaged if dropped or crushed Storage temperatures may be too low or too high Possible Hazards and Risk Rating (Rating Scale 1-5) a) b) c) d) Harmful effects from frost bite or tissue damage - 3 (Moderate or Significant). Harmful effects from contact with HTIceGel pack contents - 2 (Low or Minor) Harmful effects from unprotected needle tips - 3 (Moderate or Significant) Contact with broken glass and/or leaked contents of insulin vials - 3 (Moderate or Significant) e) Insulin may be rendered impotent by storage at temperatures above 10 oc (50.0oF) or below 2oC (35.6oF) - 4 (High) 4.3 Levels of Acceptable Risk (Rating Scale 1-5) a) b) c) d) e) 4.4 Harmful effects from frost bite or tissue damage - 2 (Low or Minor) Harmful effects from contact with HTIceGel pack contents - 2 (Low or Minor) Harmful effects from unprotected needle tips - 2 (Low or Minor) Contact with broken glass and/or leaked contents of insulin vials - 2 (Low or Minor) Insulin may be rendered impotent by storage at temperatures above 10 oc (50.0oF) or below 2oC (35.6oF) - 2 (Low or Minor) Reduction in Risk Levels a) Clear Instructions for Use including identification of the possible hazard, recommend the use of gloves when handling frozen ice packs b) Clear Instructions for Use including identification of the possible hazard (See User Instructions and attached MSDS) c) Attention to the needle manufacturer's instructions for protection from and disposal of sharps 12 of 16

13 d) Clear Instructions for Use including identification of the possible hazard; inspection of the Insulin vials, cartridges and pen systems prior to placing in the Personal Diabetic Pack e) Clear loading procedure; use of digital thermometer or temperature indicating strips recommended. 4.5 Determine Safety Adequacy of the Device (Rating Scale Low, Medium, High) a) b) c) d) 5. User safety, High In Transit Safety, High Patient Safety, High Disposal safety, High Harmonized and Other Standards In accordance with Article 5 of the Medical Device Directive, the following Medical Device Harmonized Standards have been taken into account in the design and production of the Product. Other Standards consulted are also listed. EN 724: Guidance on the application of EN (ISO 9001:2008) and EN (ISO 9002) for non-active Medical Devices EN 46001: Specification for the application of ISO 9001 to the manufacture of Medical Devices EN ISO 11197:2009 (Formerly EN 793:1998) - Medical Supply Units EN 980: Graphical Symbols for Medical Device Labelling EN 1042:2008+A1: Medical Devices, application of Risk Management ISO : General product safety, ease of operation and design requirements for context of use and user characteristics IES Ingress Protection. Drgrees of Protection provided by enclosures (IP Code) 6. Quality Management 6.1 ISO9001: 2008; GB/T of 16

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15 6.3 Quality Management Plan The manufacturer has implemented and shall maintain a verifiable and auditable Quality Plan within the ISO9001: 2000 environment for the production, packaging and dispatch of the Personal Diabetic Packs YBH-2011, YBH-2113, YBH-2517 and YBH The key quality consideration shall be that the Personal Diabetic Packs YBH-2011, YBH-2113, YBH-2517 and YBH meet the Product specifications herein. The Quality Standard is based on the Customer requirement for a safe, reliable and presentable product of consistent good quality with clear and comprehensive User Instructions. 7. CE Marking (Article 17) The CE marking of conformity, as shown in Annex XII, shall appear in a visible, legible and indelible form on the product and on the instructions for use. Minimum height shall be 5 mm. The scale shall be strictly according to the following template CE Marking Mandatory User Instructions and Labeling As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out on the leaflet 15 of 16

16 supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, instructions for use are not needed for devices in Class I or IIa if they can be safely used without such instructions. Where appropriate, this information could take the form of symbols and pictograms. Any symbol used must conform to the relevant harmonious standards. In areas for which no standards exist, the symbols and colors must be described in the documentation supplied with the device This Technical File was compiled by Russell Gibbons B.Mech.E., B.Mech.Elec.E. ( ) for and on behalf of the Manufacturer, International Haotian Technology Co. Ltd. The information contained herein was compiled on the date of issue and is revised from time to time. To the extent of our knowledge and belief the information contained herein is accurate and reliable. 16 of 16