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PULSE OXIMETER (Masimo RAD-5) + accessories

https://unicat.msf.org/cat/product/12862
STD EEMDPOXE4--

Valid Article

Former Code(s): EANEOXYM4--
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.
Z1203020408 - Pulse oximeters
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.
IIb
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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Documents

PULSE OXYMETER (Masimo RAD-5)

Definition

Portable device allowing to monitor arterial oxygen saturation (% SpO2) as well as the pulse rate (beats/minute). This non invasive continuous measurement is taken thanks to a sensor placed on a finger, a toe or an ear lobe.

Specifications

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Quality standards

ISO 80601-2-61, 2017, edition 2, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Components

  • 1 x Pulse oxymeter RAD-5 ref. 9112 or 9214
  • 1 x rubber protective case ref. 1981
  • 1 x patient extension cable RED LNC-04
  • 2 x reusable universal adult sensors LNCS-DCI ref. 1863
  • 1 reusable paediatric multisite sensor LNCS-YI ref. 2258
  • 2 boxes of 100 adhesive tapes (wraps) each for neonate sensor LNCS-YI ref.1598
  • 1 box of 100 adhesive tapes (wraps) for sensor LNCS-DCI ref. 1597
  • 4 batteries AA (non- rechargeable!)
  • 1 x English and French instructions for use ref. 13261 - 13017

Technical specifications

  • Case with LED screen displaying:
    • pulse rate (bpm)
    • oxygen saturation (SpO2)
    • perfusion index (PI)
    • warning lights (sensor condition, system failure and low battery)
  • Saturation accuracy: 70-100%
  • Pulse rate accuracy: 25-240 bpm
  • Can be used continuously in adults, children, neonates
  • Visual and audio alarms
  • Runs on 4 batteries type R6
  • Batteries capacity up to 48 hours
  • Operating conditions
    • temperature: 5ºC to 40ºC
    • humidity: 5% to 95%, non condensing
    • altitude: 1060 to 500 mbar
  • Weight: ± 0.4 kg
  • Dimensions: 17.5 x 7.6 x 3.6 cm

Instructions for use

Remarks

  • The new sensors are compatible with the previous Nellcor models: N20PA/NPB40. The connection between the sensor and the cable is always grey (sensor) - white (cable).
  • The new model of Masimo RAD-5 has a red connection and needs a red connection cable LNC-04 ref. 2055 for the sensors (wraps).
  • The old models (<2010) with white connector need the white connection cable LNC-4 ref. 2017 for the sensors (wraps).

Be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.

Make diagnosis and treatment decisions based on trends in pulse oximeter readings over time, rather than absolute thresholds.

Precautions for Use

To prevent batteries from deteriorating, it is recommended to remove them when the device is unused for a prolonged period or stored under damp conditions.

Storage

  • Storage temperature: -40ºC to 70ºC

MSF requirements

Essential for any emergency room, ICU and delivery room.

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