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Mistral-Air receives 510(k) clearance

 

07-2010 Mistral-Air receives 510(k) clearance

The Mistral-Air Plus Forced Air Warming Unit has received a 510(k) clearance of the FDA U.S. Food and Drug administration.

Introduction
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.
Read more about 510(k) clearance
 

Download certificate

 

Press Release Fluido Junior

 

The Fluido® Junior is a small device that can be used in the operating theatre, ICU and recovery room to warm fluids that are delivered to a patient via an intra-venous catheter.

The Fluido® Junior, low flow application, can be used for every patient and is an addition to the Fluido®, Fluido® AirGuard System , high flow application, patient blood and fluid warming systems.

All anesthetized patients are susceptible to hypothermia.
Inadvertent hypothermia is a frequent, yet preventable, complication of surgery and is associated with an increased rate of wound infection (SSIs)(1), increased length of hospital stay(2) and higher mortality rates(3).

  

 

Any patient undergoing anesthesia, no matter age or physical condition, is susceptible to unintended hypothermia because anesthetized patients cannot control their temperature.

“At TSCI we are focused on patient temperature management and are convinced that the Fluido® Junior will contribute in keeping patients normotherm. The ease of use and absence of maintenance will contribute to a quick improvement of today’s patient outcome” comments Peter de Jong, Managing Director TSCI.

About TSCI B.V.
TSCI B.V., headquartered in Amersfoort, The Netherlands is the developer and manufacturer of patient warming systems including Fluido®, Fluido® AirGuard System, Fluido® Irrigation and Mistral-Air product lines.
TSCI is a member of The Surgical Company Group, headquarters in The Netherlands.

References

  • Barie, PS. Surgical Site Infections: Epidemiology and Prevetion. Surgical Infections. Vol 3, Supplement 2002;S-9S-21.
  • Feran L. American Society of PeriAnesthesia Nurses Development Panel. Clinical Guideline for the Prevention of Unplanned Perioperative Hypothermia. Journal of PeriAnesthesia Nursing. Oct, 2001:Vol 16(5); pp 305-314.
  • Tryba M, Leban J, et al. Does active warming of severely injured trauma patients influence preoperative morbidity? Anestesiology. 1996: 85: A283 

 

Euroanaesthesia 2010, a great succes for TSCI


Over 5000 delegates have visited the Euroanaesthesia 2010 in Helsinki, Finland.

TSCI presented their products on a 3 x 9m stand and launched the new exiting blood and fluid warmer the “Fluido® Junior”.  Delegated have shown a lot of interest, as patient care, especially patient temperature management is becoming a more discussed item in every hospital all over the world.

click here for the Press Release of the Fluido® Junior 

TSCI Stand (click to enlarge)
    

World Cup 2010

The Euroanaesthesia was held during the start of the 2010 World Cup.
TSCI stimulated the soccer spirit. Inspired en encouraged by a Dutch amateur soccer player, all delegates could win an IPOD Shuffle, by trying to shoot some goals at the TSCI stand.

IPOD winners: (click to enlarge)

   
     
   

 Congratulations & Thank you!

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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