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(monitor VS8/ePM) SpO2 SENSOR neonate, foot reusable 518BLH

https://msf.oodin.sh/cat/product/96677
STD EEMDMONA2315

Valid Article

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.
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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(moni VS8/ePM) SpO2 SENSOR adult finger-clip

Definition

Caution: EEMDMONA2325 is meant to be used in adults. Due to a potential risk of soft tissue injury, it should only be used in children during an emergency as spot check if the child/neonate article is not immediately available. The most appropriate article should be used thereafter: EEMDMONA2326 SpO2 SENSOR child finger-clip reusable 512H or EEMDMONA2315 SpO2 SENSOR neo foot tie reusable 518BLH

Specifications

Models 512E & 512F is intended for adult patients weighing more than 30 kg.

Models 512G & 512H is intended for child patients weighing between 10 and 30 kg.

Model 518BLH is intended for neonate patients weighing less than 5 kg.

Instructions for use

  • Mindray SpO2 sensors only work with Mindray (blue) connectors
  • monitor and change application site every 2-4 hours if skin characteristics change: irritation, reddening, blistering, edema, burns - or more frequently with neonates, patiens with poor periferal blood circulation, under phototherapy or when "SpO2 low signal quality" message appears.
  • Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line.
  • pulse oximeter function should not be used for apnea monitoring or arrh.ythmia analysis
  • For neonatal patients, make sure that all sensor connectors and adapter cable connectors are outside the incubator. The humid atmosphere inside can cause inaccurate measurements.