PRODUCT SAFETY DATA SHEET

Transcription

1 SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER Product Product Name Other Names - Manufacturer s Product Code and Use The RENASYS GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. RENASYS GO is appropriate for use on the following wounds: Chronic, Acute, Traumatic, Sub-acute and dehisced wounds, Ulcers (such as pressure and diabetic), Partial thickness burns, Flaps and grafts Supplier Australia: Company Smith & Nephew Pty. Limited Address 85 Waterloo Road, North Ryde, NSW 2113 Telephone No. Customer Service: (02) Toll Free (Australia): Emergency Tel. Nos. (02) (business hours) New Zealand: Company Smith & Nephew Ltd Address Unit A, 36 Hillside Road Wairau Valley, Auckland 0627 Telephone No. Customer Service: Toll Free (New Zealand): Emergency Tel. Nos. +64 (0) (business hours) SECTION 2 HAZARDS IDENTIFICATION Hazard Classification Hazards Overview Risk Phrases Safety Phrases NON-HAZARDOUS SUBSTANCE. No hazard expected under normal conditions of handling and use. The product contains a Lithium-Ion battery that if compromised the contents are classified as Hazardous (See PSDS for Lithium-Ion battery in NPWT Device). Date of Issue: 16/02/2017 Page 1 of 5

2 SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS The RENASYS GO - Negative Pressure Wound Therapy system comprises of the RENASYS GO device, 300ml or 750ml waste canister, and external charger. SECTION 4 FIRST AID MEASURES Swallowed Eye Skin Inhaled SECTION 5 FIRE FIGHTING MEASURES Hazards From Combustion Products Suitable Extinguishing Media Fire-fighting Procedures Hazchem Code The PC/ABS case is a combustible material, which under certain conditions could be flammable if exposed to a heat source of greater than 288 C. A heat source of greater than 102 C may cause dripping and flow of molten material. If ignited toxic fumes may be expelled including ammonia, aromatic and aliphatic hydrocarbon fractions, carbon monoxide, carbon dioxide, and hydrogen cyanide. Fire may be controlled with carbon dioxide and dry powder fire extinguishers. If fire is in a confined space, self-contained breathing apparatus should be worn. NB as this is an electrical device, water should not be used as an extinguishing medium if installed into the mains electricity. A dry chemical carbon monoxide and foam is required for extinguish due to the lithium-ion batteries. Appropriate self- contained breathing apparatus should be worn when fighting a fire. Keep all personnel away from the fire. SECTION 6 ACCIDENTAL RELEASE MEASURES Spill / Leak Procedure Date of Issue: 16/02/2017 Page 2 of 5

3 SECTION 7 HANDLING AND STORAGE Handling Advice Storage Advice Refer to instructions for use provided with the product. Do not puncture, crush, incinerate or expose the battery to temperatures exceeding 100 0C. Avoid using around flames or ignition. Use only AC power cord provided with the device. For optimal performance store in a dry place, at F/ C out of direct light. Keep away from sources of ignition. SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES The RENASYS GO device includes a vacuum pump, 2 printed circuit boards, electrical wiring, 1 Li- Ion Battery, silicone tubing, and nylon tubing connectors. The outer case is manufactured from PC/ABS SABIC CYCOLOY C6200 a fire proof material. All components used within the device are RoHS compliant. SECTION 10 STABILITY AND REACTIVITY For optimal performance store in a dry place, at F/ C out of direct light. SECTION 11 - TOXICOLOGICAL INFORMATION SECTION 12 ECOLOGICAL INFORMATION SECTION 13 DISPOSAL CONSIDERATIONS Method of Disposal Disposal in accordance with local / national environmental waste Date of Issue: 16/02/2017 Page 3 of 5

4 guidelines, for electrical medical devices. Disposal of battery: Follow local guidelines and battery label for proper disposal. Do not puncture, crush, incinerate or expose the battery to temperatures exceeding 100 C Improper disposal of Lithium-ion battery may result in fire explosion and burns. SECTION 14 TRANSPORT INFORMATION The product is compliant with the transportation of lithium-ion batteries as regulated by the International Air Transport Association (IATA), International Civil Aviation Organisation (ICAO), International Maritime Dangerous Goods Code (IMDG) and the Australian Dangerous Goods Code. Lithium-ion batteries meet the requirements of: Class 9 miscellaneous dangerous goods UN 3481, Lithium ion batteries contained in equipment. Subject to Special Provisions SP 188 and SP 230. SECTION 15 REGULATORY INFORMATION This product is registered as a medical device in Australia and New Zealand. Poison Schedule Not a Scheduled Poison. SECTION 16 OTHER INFORMATION CONTACT POINT: CUSTOMER SERVICE Telephone: (02) Date of Issue: 16/02/2017 This PSDS summarises our best knowledge of the health and safety hazard information of the product and how to safely handle and use the product in the workplace. Each user should read this PSDS and consider the information in the context of how the product will be handled and used in the workplace including in conjunction with other products. If clarification or further information is needed to ensure that an appropriate risk assessment can be made, the user should contact this company. Our responsibility for products sold is subject to our standard terms and conditions, a copy of which is sent to our customers and is also available on request. Date of Issue: 16/02/2017 Page 4 of 5

5 REVISION HISTORY Revision Number Description of Change Effective Date 0 First Issue Date of Issue: 16/02/2017 Page 5 of 5