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FINGERTIP PULSE OXIMETER (Mightysat 9707)

https://unicat.msf.org/cat/product/66434
STD EEMDFPOE01-

Valid Article

Former Code(s): EEMDPOXE6--
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
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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FINGERTIP PULSE OXIMETER (Mightysat 9707)

Definition

A portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry.

The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate. The device is typically applied to the fingertip.

It may be used in Emergency rooms and outpatient departments to perform triage and collect vital signs (SpO2, HR; RR; perfusion index). In inpatient wards it allows to collect vital signs in a regular but non continuous manner.

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

Technical specifications

  • SpO2 and pulse monitor integrated into fingers/toe clip
  • Configurations required to apply to
    • adults and children
    • all skin pigmentations
  • Measurement description:
    • Functional Oxygen Saturation (SpO2):
      • detection range: 0 –100 %
      • resolution: 1% or less
      • accuracy in the range 70-99%: within +/-3%
    • Pulse Rate (PR):
      • detection range: 25–240 bpm
      • resolution: 1bpm or less
      • accuracy: +/- 3 bpm
    • Perfusion Index (Pi): 0 .02–20%
  • Display shows % SpO2, pulse rate, signal quality, sensor error or disconnect and low battery status.
  • Audible and visual alarms for
    • sensor error or disconnected, system errors, low battery.
    • low/high saturation and pulse rate.
  • ​Automatic power-off
  • Power supply:
    • Two 1.5 Volt AAA batteries, rechargeable
    • batteries must allow at least 2500 spot checks at 30s per spot check, or at least 12 hours of operation
  • Operating conditions:
    • Temperature: 5 to 40°C
    • Humidity: 10 to 95%, non-condensing
    • Atmospheric Pressure: 540 to 1060 mBa

Dimensions

  • 7.4 x 4.1 x 3.0 cm
  • Weight: 73 g

Instructions for use

Fingertips pulse oximeter are not adapted for neonate and paediatric patients.

Fingertip pulse oximeter are less accurate than the handheld oximeters and battery level of the device could have an influence on the result.

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

These devices do not contain the necessary alarms and should not be used for continuous monitoring.

Maintenance

Clean and disinfect the fingertip oximeter after each patient tested, according to the manufacturer's instructions and IPC recommendations.

MSF requirements

A fingertip pulse oximeter allows to perform rapid assessment at triage points or when measuring vital signs at a lower cost than usual pulse oximeter/monitor.

Fingertip pulse oximeters allow to spare more advanced devices for continuous/continual monitoring of patients.

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