Data Sheet Mistral-Air® Blankets Plus
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Data Sheet Mistral-Air® Blankets Plus Description Mistral-Air® Blankets Plus The Mistral-Air® Warming System is a forced air warming system and comprises of a warming unit and a variety of blankets. It is intended to raise and/or maintain patient temperature by means of surface warming. Intended patient population: adults and paediatric patients. Intended to be used only by trained clinicians in clinical areas during the entire perioperative pathway. Single use Mistral-Air® Blankets should be used only with a Mistral-Air® Warming Unit (Commingling Use statement) Blankets Plus: Non-woven materials Polypropylene and Polyethylene Adhesive tape: Pressure sensitive hot-melt on synthetic rubber base Face shield: Polyethylene Connector: Cardboard 16 CFR 1610 in relation to: Flammability of Clothing Textiles, Class 1. EN 13795-1 in relation to: Resistance to microbial penetration Cleanliness Linting Bursting strength Tensile strength ISO 10993 series in relation to: Cytotoxicity Sensitization Irritation Class I device and CE marked as per Regulation (EU) 2017/745 (EC Declaration of Conformity) Class Is device and CE marked as per Directive 93/42/EEC (CE certificate 2081762CE04) According to hospital protocol or local regulation (Disposal Statement) Details indicated in the Packaging overview below Double corrugated cardboard box Inner bags: Polyethylene Individual blanket bags*: Polyethylene or Tyvek pouches (in case of sterile blankets) One Instructions For Use (IFU) per box LOT number and REF number printed on single bag label and box label Time stamp printed on blanket and box label PVC free (PVC Free Statement); MA2286 has a PCV tube Recommended storage conditions Clean, dry, between + 16 ºC and + 25 ºC (preferably room temperature), keep away from sunlight Always consult the latest User and Technical Manual of the Mistral-Air Warmi

Data Sheet Mistral-Air® Blankets PlusSpecifications Description

Data Sheet Mistral-Air® Blankets Plus Properties Description Reference number Hose inlet Face shield Adhesive Tape on width Adult Plus Paediatric Plus Neonatal Plus Lower Body Plus Upper Body Plus Half Upper Body Plus Torso Plus Full Underbody Plus Half Underbody Plus Paediatric Underbody Plus Surgical Access Plus Sterile inside surgical access Surgical Access Plus inside surgical access Lower Surgical Access Plus Sterile Cardiac Blanket Plus Sterile Lithotomy Plus

Data Sheet Mistral-Air® Blankets PlusPackaging Description