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PATIENT SIMULATOR, Rigel UniSim+PulsR

https://unicat.msf.org/cat/product/68360
STD EIMTSIME1--

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Former Code(s): EHOEZFR0897
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.
PE
The order of this product needs to be justified and is only acceptable under certain conditions.
UN3496
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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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PATIENT SIMULATOR, vital signs, Rigel

Definition

A battery-powered electronic test device designed to simulate and measure different vital signs of a patient to calibrate or test a various medical monitoring devices (e.g. anaesthesia monitor, ECG, pulse oximeter, dinamap).

It consists of a hand-held electronic box for setting and measuring parameters as well as a module per parameter which is connected to it. The parameters controlled with this device are ECG curve, heart rate, oxygen saturation, temperature, invasive and non-invasive blood pressure. This device must be used once a year on each of the monitoring machines to ensure quality control of the parameters displayed on the monitors. This patient simulator must be calibrated by the manufacturer once a year. It must be used by a technician or biomedical specialist trained in its use.

Specifications

The Rigel UNI-SiM Vital Signs Simulator is a battery powered 6 in 1 vital signs simulator able to undertake six synchronised vital signs parameters tests.

It enables quick, easy and accurate simulations of NiBP, SpO2, ECG, temperature, IBP and respiration functionality.All the values of these parameters can be changed according to the needs of the test, and the simulation of problem curves is possible in order to control alarms (arrhythmias, fibrillation...).​

Manufacturer specific simulation curves can be created and uploaded to further aid the accuracy.

The device has a built-in SD card for easy transfer of test data.

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Components

  • Vital signs simulator
  • ​Carrying Case
  • 5-pc tubing adaptor (NiBP)
  • SpO2 probe interface
  • ECG interface box
  • Power Supply
  • Calibration Certificate

Technical specifications

Simulation Functions

  • NiBP non invasive blood pressure (systolic and diastolic)
  • ECG
  • Respiration
  • SpO2
  • IBP‌ (invasive blood pressure)
  • Temperature

Dimensions

270 x 110 x 75 mm

Transport Dangerous Goods

Contains a NiMH battery (7.2 V 2400 mAh)

  • Battery listed under UN3496.
  • This battery benefits from the Special Provision A199 (Special provision) which allows it to be exempted from the constraints of IATA regulations.
  • The device can therefore be sent in a standard package and without any special labelling.
  • The presence of dangerous goods and the Special Provision A199 must still be mentioned in the waybill, and the battery's safety data sheet must be provided to confirm the information given.

Instructions for use

Maintenance

An annual calibration by the manufacturer is necessary to ensure that the simulation of the parameters is correct.

MSF requirements

Testing equipment for pulse oximeters, multi-parameter monitors, dinamap monitors, ECGs and any other medical equipment which require simulation of a patients circulatory, respiratory, or cardiac functions.

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