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PULSE OXIMETRY TESTER (MASIMO RAINBOW 20 PIN)

https://unicat.msf.org/cat/product/94006
NST EIMTPOXE2--

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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.
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The order of this product needs to be justified and is only acceptable under certain conditions.
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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PULSE OXIMETRY TESTER (MASIMO RAINBOW 20 PIN)

Definition

The device is used to verify the general functionality of Masimo devices or devices containing Masimo rainbow SET Pulse CO-Oximetry. The Tester allows a connection to Masimo rainbow SET devices.

Specifications

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Technical specifications

The‌ tester is connected ot the cable connector of the oximeter. When the oximeter is switched on the resulting representative data points should be as follows:

  • SpO 2 = 81% ± 3%.
  • Pulse Rate = 61 bpm ± 1 bpm.
  • SpCO® = 7% ± 3%. *
  • SpMet® = 3.5% ± 3%. *
  • SpHb® = 14.0 g/dl ±1 g/dl. *

* Not applicable for the Rad5V

NOTE:

  • SpO 2 and SpMet will alarm at factory default alarm values.
  • If the displayed values differ from the specified values, contact Masimo Technical Support.

Instructions for use

See instructions for use

Precautions for Use

The Tester is not to be used as a calibration tool for pulse CO-Oximeters.

Warnings

  • The Tester should be free of visible defects. Never use a damaged product, or one with an open enclosure shell or exposed electrical contacts.
  • Failure to properly connect the Tester to the device or patient cable will result in intermittent readings, inaccurate results or no reading.
  • Functional Testers cannot be used to assess accuracy

Maintenance

Cleaning

Clean the Tester by wiping with 70% isopropyl alcohol and allowing it to dry thoroughly.

Caution

Do not use petroleum-based or acetone solutions, or other harsh solvents for cleaning. These substances affect the devices materials and device failure can result

Storage

Store in a dry place

MSF requirements

For testing‌ Masimo Pulse oximetry devices??

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Description approved by referent of OCG (Malcolm Townsend) in December 2023.