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(resuscitator Laerdal Upright) OXYGEN KIT complete 846151

https://unicat.msf.org/cat/product/70138
STD EANERESU1NU1

Valid Article

Article is intended to be used with children (<12 years) ONLY.
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
R03020201 - Manually operated pulmonary resuscitators
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(resuscitator Laerdal Upright) OXYGEN KIT

Definition

Laerdal Upright Resuscitator (”Upright”) is a self-inflating, manual, reusable resuscitator intended for newborns and infants up to 10 kg body mass who require respiratory support. Upright can provide supplemental oxygen only when used with the accessory Oxygen Kit.

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Specifications

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Quality standards

ISO 10651-4, 2023, edition 2, Lung ventilators - Part 4: Particular requirements for user-powered resuscitators

Technical specifications

Delivered Oxygen Concentration Measured under room temperature conditions:

20 ml tidal volume @ 60 breaths / min

150 ml tidal volume @ 25 breaths / min
oxygen flow (l/min)no reservoirwith reservoirno reservoirwith reservoir
140%46%52%71%
252%67%63%92%
358%89%73%96%

Instructions for use

Upright's pressure release valve can be operated as normal when the Oxygen Kit is attached. If any components are loose, then tighten or reassemble the device and test according protocol.

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Precautions for Use

If any of the above tests fail: Disassemble, inspect the components, reassemble and repeat the complete “Testing before use” procedure

Maintenance

The Oxygen Kit may be reused provided reprocessing procedures are followed between each patient use. The kit (except for the Oxygen Reservoir and the Oxygen Tube) must be cleaned and disinfected before first use.