2007-8-14 · Instructions for Use respironics SINGLE PATIENT USE ONLY Intended UseThe Image 3 Disposable Full Face Mask is intended to provide an interface for adult patients when used with Respironics CPAP and bi-level systems. The mask covers the nose and mouth and is designed to be worn with the Respironics Disposable 3-Strap Headgear.
2003-5-9 · Patient 28 Isolated Power System • Advantages if isolated power systems are No macroshock hazards for a single fault condition.No sparks with single fault conditionSingle fault does not affect performance • Disadvantages are If there is a single fault condition problems may last for a very long time before being detected.
2021-4-15 · Single-use devices PS ID Category Responsible Body Review Due Effective Date P1 Policy Policy Committee Sept 2015 May 2016 1. Introduction The responsibility of designating a medical device as single use or single patient use lies with the manufacturer and this must be clearly stated on the medical device or in the instructions for use.
2007-8-14 · Instructions for Use respironics SINGLE PATIENT USE ONLY Intended UseThe Image 3 Disposable Full Face Mask is intended to provide an interface for adult patients when used with Respironics CPAP and bi-level systems. The mask covers the nose and mouth and is designed to be worn with the Respironics Disposable 3-Strap Headgear.
2009-9-7 · The official definition of the single-use symbol given in EN 980 is Do not reuse . For medical devices it is also generally accepted that single use means for use on a single patient . Guidance from the MHRA suggests that single use devices should only be used for a single procedure however the term procedure is not defined.
2021-3-12 · (2) accessory for a medical device means an article which whilst not being itself a medical device is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical
Do not use if package is damaged Indicates a medical device that is intended for one use or for use on a single patient during a single procedure Do not use if package is damaged Discard excess unused media following warming Indicates the medical device manufacturer Indicates the manufacturer s batch code so that the batch or lot can be identified
2005-12-2 · Items for singleuse must be discarded at the point of use as soon as possible after use. Items labelled Single patient use may be used more than once on the same patient as per the manufacturer s instructions. As with all sterile items you need to check the integrity of the packaging before use.
2017-2-28 · A single-use device as is implied by its name is a device which is intended to be used on a single patient for a single procedure. This means that such a device should not be used again on the same patient and is not intended to be reprocessed. The current symbol being used to indicate a single-use device is shown below. Tighter healthcare
2020-3-17 · Single patientmultiple use Indicates a medical device that may be used multiple times (multiple procedures) on a single patient Symbols to be used on labelling (ISO 15223)
2021-7-21 · Indicates a medical device that is intended for one single use only. Consult instructions for use 5.4.3. Indicates the need for the user to consult the instructions for use. Consult instructions for use 5.4.3. A.16 NOTE A.16 Example of use of symbol 5.4.3 "Consult instructions for use" for an electronic instruction for use (eIFU)
2014-3-18 · A medical device labelled as single use indicates that the device has only been validated and designed for use for a single occasion. It is not intended to be reprocessed and/or used on another patient. The term Single Use means that the manufacturer intends the device to be used once and then discarded and considers
2015-1-6 · between each use. Items should not be labelled as "single patient use" and also contain the symbol . If this is the case the manufacturer should be contacted for clarification. Why shouldn t they be reused Serious incidents relating to reuse of single-use devices have been reported. Also if you reuse a single-use device you may be legally liable for the safe performance of the device.
To meet a regulatory requirement medical devices must indicate if the device may be used mutiple times on a single patient. This symbol has been prepared to reduce the need for multiple translations of words into national languages simplify and rationalise the labelling of medical devices thereby reducing risk of misidentification promoting safety for the patient and reducing the amount of
2021-5-5 · At the same time Medtech Europe recommends the use of the present symbol for the Single patientmultiple use meaning. This symbol has been equally validated according to international standards with healthcare professionals and patients. Its use is supported by references in the ISO and IMDRF documents. 10. Single PatientMultiple use
Each graphical symbol is identified by a reference number and contains a title graphical representations in vectorized and non-vectorized formats and some additional data as applicable such as the function or the description of the symbol the intended use related symbols or publications.
2018-2-21 · The process of single-use device reprocessing Single-use medical device reprocessing entails disinfect-ing cleaning sterilizing packaging labeling and storing a used or opened package of a medical device to be placed into service again.7 Reusing single-use medical devices has been happening since the late 1970s.8 Single-use medical devices
Each graphical symbol is identified by a reference number and contains a title graphical representations in vectorized and non-vectorized formats and some additional data as applicable such as the function or the description of the symbol the intended use related symbols or publications.
2021-4-14 · Single patient-multiple use Indicates a medical device that may be used multiple times (multiple procedures) on a single patient ISO 15223-1 2016 and ISO 15223-1 2020(E) Reference no. 5.5.1. Medical devices — Symbols to be used with medical device labels labeling and information to be suppliedPart 1 General requirements.
2003-5-9 · Patient 28 Isolated Power System • Advantages if isolated power systems are No macroshock hazards for a single fault condition.No sparks with single fault conditionSingle fault does not affect performance • Disadvantages are If there is a single fault condition problems may last for a very long time before being detected.
2003-5-9 · Patient 28 Isolated Power System • Advantages if isolated power systems are No macroshock hazards for a single fault condition.No sparks with single fault conditionSingle fault does not affect performance • Disadvantages are If there is a single fault condition problems may last for a very long time before being detected.
Do not use if package is damaged Indicates a medical device that is intended for one use or for use on a single patient during a single procedure Do not use if package is damaged Discard excess unused media following warming Indicates the medical device manufacturer Indicates the manufacturer s batch code so that the batch or lot can be identified
2012-10-20 · Symbol that may be used in place of the statement "CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician." Symbol for "Use By." This symbol shall be adjacent to the expiration date as given in EN 28601 expressed as four digits for the year and two digits for
2021-7-22 · a . The earlier segment of a biphasic plot of log C against t (following intravenous injection of a drug) represents the "distributive phase" of a drug s sojourn in the body. a is used as a subscript for pharmacokinetic parameters appropriate to the distributive phase e.g. t 1/2a V da etc.. Cf. b Compartment(s) Volume of Distribution Half-Life
2021-4-14 · Here you will see the 5 flowchart symbols that are very popular and commonly used in almost every flowchart. The Oval or Pill Shaperepresents the start/end. The Rectangle Shaperepresents a process. The Parallelogram Shaperepresents the input/output of the information. The Diamond Shaperepresents a decision.
2021-7-22 · Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury illness or death of the patient. Complications may occur if all the air has not been removed from the infusion catheter and displaced with saline prior to
— symbol 5.5.5 modified the description of the symbol and the requirement regarding use with IVD — A.15 added the examples of the placement of the eIFU indicator. A list of all parts in the ISO 15223 series can be found on the ISO website.
2021-7-22 · a . The earlier segment of a biphasic plot of log C against t (following intravenous injection of a drug) represents the "distributive phase" of a drug s sojourn in the body. a is used as a subscript for pharmacokinetic parameters appropriate to the distributive phase e.g. t 1/2a V da etc.. Cf. b Compartment(s) Volume of Distribution Half-Life
To meet a regulatory requirement medical devices must indicate if the device may be used mutiple times on a single patient. This symbol has been prepared to reduce the need for multiple translations of words into national languages simplify and rationalise the labelling of medical devices thereby reducing risk of misidentification promoting safety for the patient and reducing the amount of
2021-4-14 · Single patient-multiple use Indicates a medical device that may be used multiple times (multiple procedures) on a single patient ISO 15223-1 2016 and ISO 15223-1 2020(E) Reference no. 5.5.1. Medical devices — Symbols to be used with medical device labels labeling and information to be suppliedPart 1 General requirements.
Do not use if package is damaged Indicates a medical device that is intended for one use or for use on a single patient during a single procedure Do not use if package is damaged Discard excess unused media following warming Indicates the medical device manufacturer Indicates te manufacturer s batc code so that the batc or lot can be identified
2019-10-18 · Function/description To indicate that the medical device may be used multiple times (multiple procedures) on a single patient. All formats RSD 3 420 00. Add to basket. This symbol is part of collection (s) ISO 7000 Graphical symbols for use on equipment. Full collection of ISO and IEC symbols.
Pulse Trace. 489 562 50. Poison Bottle Medicine. 304 475 42. Skull Human Head. 65 57 20. Caduceus Medical Symbol. 143 186 19. Brain Icon Human.
Do not use if package is damaged Indicates a medical device that is intended for one use or for use on a single patient during a single procedure Do not use if package is damaged Discard excess unused media following warming Indicates the medical device manufacturer Indicates the manufacturer s batch code so that the batch or lot can be identified
2018-9-26 · It will have this symbol on the packaging or the device 2 What does single-use mean Do not reuse. A single-use device is used on an individual patient during a single procedure and then
To meet a regulatory requirement medical devices must indicate if the device may be used mutiple times on a single patient. This symbol has been prepared to reduce the need for multiple translations of words into national languages simplify and rationalise the labelling of medical devices thereby reducing risk of misidentification promoting safety for the patient and reducing the amount of training required by
2021-7-21 · AF531 single-use with EE leak 1/NE nebulizer elbow CapStrap headgear medium 10 1072619 989805635011 AF531 with EE leak 1/NE nebulizer elbow CapStrap headgear large 10 1072620 989805635021 Intended for use by pediatric patients 7 years or older and > 20kg.
2021-7-16 · The "Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals Final Guidance for Industry and FDA" document provides guidance to third party and hospital
2020-8-15 · According to the Food and Drug Administration s (FDA s) guidance entitled Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitalsexternal icon "a single-use device also referred to as a disposable device is intended for use on one patient during a single
— symbol 5.5.5 modified the description of the symbol and the requirement regarding use with IVD — A.15 added the examples of the placement of the eIFU indicator. A list of all parts in the ISO 15223 series can be found on the ISO website.
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