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PREVENA PLUS - Acelity

under IEC 60601-1. IP22 - Protection level against ingress of solid foreign objects and liquids. All alerts are classified as low priority according to IEC 60601-1-8. Conforms to: IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-8 Electrical Equipment Interference Cell phones or other similar products could affect the therapy unit.

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  60601, Iec 60601 1 6

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CLINICAL GUIDELINES

www.acelity.com

V.A.C.® Therapy and Hyperbaric Oxygen ... be readily integrated into the clinician’s wound healing practice, to help optimize patient care. This advanced wound healing technology is coupled with microprocessor-controlled therapy ... • Ensure a …

  Guidelines, Practices, Clinical, Therapy, Oxygen, Clinical guidelines, Hyperbaric, Hyperbaric oxygen

CLINICAL GUIDELINES

www.acelity.com

V.A.C.® Therapy and Hyperbaric Oxygen ... be readily integrated into the clinician’s wound healing practice, to help optimize patient care. This advanced wound healing technology is coupled with microprocessor-controlled therapy ... • Ensure a …

  Practices, Therapy, Oxygen, Hyperbaric, Hyperbaric oxygen

PREVENA PLUS 125 THERAPY UNIT WITH PREVENA PLUS …

www.acelity.com

125 and PREVENA PLUS ™125 Therapy Units are intended to aid in reducing the incidence of seroma; and in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds. • The device is not intended to treat surgical site infection or seroma.

  Risks, Reducing

PREVENA 125 THERAPY UNIT WITH PREVENA 45ML …

www.acelity.com

reducing the incidence of seroma; and in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds. • The device is not intended to treat surgical site infection or seroma.

  Risks, Reducing

PREVENA INCISION MANAGEMENT SYSTEM - Acelity

www.acelity.com

MANAGEMENT SYSTEM PREVENA ... if frank blood is seen in the tubing or in the canister, the patient should leave the PREVENA™ Dressing in place, turn off the therapy unit and seek immediate emergency medical ... Hyperbaric Oxygen Therapy (HBO): Do not take therapy units or PREVENA™ Dressings into a hyperbaric oxygen chamber.

  System, Management, Tubing, Oxygen, Management system, Incisions, Incision management system

Related documents

Medical Device Usability - BSI Group

www.bsigroup.com

• EN 60601-1-6:2010 Collateral Standard: Usability (IEC 60601-1-6:2010) – reference EN 62366 • EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) • EN 60601-1-8: 2007 - Alarm systems

  60601, Iec 60601 1 6, 60601 1 6

醫電設備電性安全測試與相關 法規實務

www.bmes.org.tw

IEC 60601-1-10 General requirements and guidelines for the application of alarms in Medical Electrical Equipment . IEC 60601-1-8 Requirements for usability (Analysis, test and validation of human factors compatibility),2007 IEC 60601-1-6 IEC 60601-1-5 Image quality and dose for X-ray equipment (Project).

  60601, Iec 60601 1 6 iec

IEC/ISO 62366 医療機器のユーザビリティー

park.itc.u-tokyo.ac.jp

• iec 60601-1-6医用電気機器のユーザビリ ティー規格が2005年に制定、isoより、これ は医用電気機器のみならずもっと広い医療 機器全体に重要な規格である。合同で新規 格とすべきと提案（jwg4を発足） • 2007年1月22日～25日jeitaにて東京会議 cdv

  60601, 62366, Iec 60601 1 6

GHTF SG2 Guidance for Adverse Event Reporting for Medical ...

www.imdrf.org

Definition taken from IEC 60601-1-6:2004. See also Annex A for examples of potential abnormal use. Immediate adverse event report: For purposes of adverse event reporting, immediately means as soon as possible, but not later than 10 elapsed calendar days following the date of awareness of the event.

  60601, Iec 60601 1 6

IEC Webstore - International Electrotechnical Commission

webstore.iec.ch

the second edition of IEC 60601‐1‐8, as well as the fourth edition of IEC 60601‐1‐2, the third edition of IEC 60601‐ 1‐6, the second edition of IEC 60601‐1‐11 and IEC 60601‐1‐12. The most significant changes are the following modifications: – updated rationale (Annex AA) and references related to advances in the ...

  International, Commission, 60601, Electrotechnical, International electrotechnical commission, Iec 60601 1 6

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