Data Sheet Mistral-Air® Blankets Plus

Product catalog summary

Description and Intended Use
The Mistral-Air® Blankets Plus are part of a forced air warming system designed to raise or maintain patient temperature through surface warming. It is intended for use with adults and pediatric patients by trained clinicians throughout the perioperative pathway. The blankets are single-use and must be used with a Mistral-Air® Warming Unit.

Composition and Compliance
The blankets are made from non-woven polypropylene and polyethylene materials, with additional components such as adhesive tape and face shields. They comply with flammability standards (16 CFR 1610) and various ISO 10993 standards related to microbial resistance, cytotoxicity, and more. The device is classified as a Class I medical device and is CE marked.

Specifications
The document provides detailed specifications for various blanket models, including dimensions, weight, and GTIN barcodes. For example, the Adult Plus model (MA2220) measures 2270 x 1330 mm with a warming surface of 1730 x 790 mm and weighs 180 grams.

Properties
Each blanket model has specific properties such as the number of hose inlets, presence of face shields, adhesive tape, and arm slits. For instance, the Adult Plus model has one hose inlet and no additional features like face shields or arm slits.

Packaging
The blankets are packaged in quantities of 40 per box, with each box containing four inner bags of 10 blankets each. Some models, like the Surgical Access Plus Sterile, are packed in Tyvek pouches for sterility.

Storage and Manufacturing
Recommended storage conditions are clean, dry environments between 16°C and 25°C, away from sunlight. The blankets are manufactured in the Netherlands.

Catalog excerpts

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

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Data Sheet Mistral-Air® Blankets PlusSpecifications Description

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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

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