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MONITOR, vital signs (Mindray VS8)+ access., 230V 50-60Hz

https://unicat.msf.org/cat/product/96455
STD EEMDMONE22-

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.
Z120302 - Vital signs monitoring instruments
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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
UN3481
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).
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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)
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
SC subscriptions: included in supply or field tools
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MONITOR, vital signs (Mindray VS8)

Definition

A device designed for spot check and recording of vital signs and routine observations of one patient: temperature, heart rate, oxygen saturation and blood pressure (diastolic and systolic) in a noninvasive manner, with adjustable alarms for these parameters.

The apparatus is used for occasional or periodic readings of vital signs in healthcare settings such as: emergency departments, general or specialized inpatient wards.

Specifications

  • Non Invasive Blood Pressure (oscillometry NIBP)
    • modes: manual, auto, STAT, sequence, BP averaging
    • parameters: systolic, diastolic, mean
    • measuring time: <15 sec typical, max 180 sec
    • range: 10-290 +/-5 mmHg
  • Pulse Rate (PR)
    • 20-300 +/- 3 bpm (from Nellcor)
    • 30-300 bpm +/- 3% (from NIBP)
    • 1 sec refresh rate
  • Oxygen Saturation (SpO2)
    • range: 0-100% (Nellcor)
    • accuracy (@>70%): +/- 2% adult, 3% neonate
    • 1 sec refresh rate
  • Other Parameters
    • 30 customizable manual input fields
  • Data History
    • up to 5000 spot checks;
    • up to 240 hrs (@ 30 sec interval) in continuous mode
    • up to 200 events (parameter or technical alarms)
  • Clincal Assistive Application
    • Early Warning Score (mews, news, pews)
    • GCS, pain score, targeted goal views
    • Orthostatic BP measurement
  • Alarms
    • prompting tone
    • 3 different tones/levels for alerts
    • Red/Yellow/Cyan LED levels
    • alarm message displayed
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Quality standards

  • EN IEC 80601-2-49, 2019, edition 1, Medical electrical equipment -- Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
  • ISO 80601-2-55, 2018, edition 2, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
  • ISO 80601-2-56, 2017, edition 2, +A1 2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
  • 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
  • EN 62304, 2006, +A1:2015 Medical Device Software - Software Lifecycle Process
  • IEC 62366-1, 2015, +AMD1:2020 MD Application of usability engineering to medical devices

Components

  • 1 x EEMDMONS2201 Power cord - EU (European)
  • 1 x EEMDMONA2200 Main unit with 8" HD Non-touch screen (with knob)
  • 1 x EEMDMONS2202 High Capacity Battery
  • 1 x EEMDMONA203 SENSOR SPO2 adult Nellcor
  • NIBP with TrueBP technology
  • Multifunctional Connectors (Nurse Call/DIAP/Battery port)
  • Nellcor SpO2 DS100A Sensor (Adu, >40kg, Finger-clip) + 2.5m Cable

Technical specifications

  • Hardware
    • 8" color TFT LCD (1024x768 pixels)
    • IPX2 ingress protection
    • 45-85 dB alarm tones
    • 1x equipotential grounding terminal
    • class 1 protection: type CF (SpO2, NIBP, TrueTemp)
    • CISPR11 RF: Group 1 Class A
    • 0.5-5V 10mA Nurse Call signal
    • optional bar code scanner
    • optional thermal printer (25mm/s)
  • Power
    • 100-240V +/-10%, 50-60Hz +/- 3Hz
    • 0.5-0.9 A; T2AL-250V fuse
    • 10.95VDC, 5000mAh Li-ion battery (>8 hrs runtime)
    • Automatic switch between battery and mains powered mode when recharging or in mains power failure
    • Shutdown delay of at least 20 min after low battery alarm
  • Environmental Requirements
    • 0-40 C operating temperature
    • 15-95% non-condensing humidity
    • 427-787 mmHg (57-105 kPa) barometric pressure
  • Communication Interface
    • Bluetooth 5
    • WiFi IEEE 802.11 a/b/g/n/ac
    • 1x RJ45
    • 2x USB 2.0
    • 1x multi functions connector
    • optional HL7, eGateway, VistaIsLink data output

Dimensions

H x W x D : 252 x 170 x 150 mm

Weight: 2.5 kg with battery

Transport Dangerous Goods

UN2800: special provisions in air (A67) and sea (238) that allow us to send the product as not subject to regulation

To be Ordered Separately

  • EEMDMONA2202 Rolling Stand (Standard) + comment Quick lock (compact with all existing models under 12" inch screen and VS) - 045-004267-00
  • EEMDMONA2307Nellcor cable+Neo Sensor - 0651-30-77023
  • EEMDMONA203 DS100A reusable sensor, Adu - 9000-10-05161
  • NIBP Tubing, Adu/Ped/Infant, with air plug connectors (3m) - 6200-30-09688
  • EEMDMONA2301 CM1201 resuable cuff, Infant, 10-19 cm, with connector - 0010-30-12157
  • EEMDDEFA206 CM1203 resuable cuff, Adu, 25-35cm,with connector - 0010-30-12159
  • EEMDMONA2303 CM1204 resuable cuff, Large Adu, 33-47cm,with connector - 0010-30-12160
  • EEMDPOXC102 Nellcor reusable SpO2 sensor, Adu/Neo, with 50pcs bandage - 9000-10-07336

Instructions for use

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Maintenance

  • Every Day (or between patients)
    • clean and disinfect main unit per user manual 20.3
    • clean and disinfect accessories per user manual 20.4
    • Visual inspection per 21.5.1
    • Power on self-test per 21.5.2
  • Every 3 Months
    • recondition battery per user manual 19.8.1
  • Every 1 Year (or after repair)
    • check battery performance per user manual 19.8.2
    • performance test (calibration) for CO2, printer (21.5.3)
  • Every 2 Year (or after repair)
    • performance test (calibration) for SpO2, NIBP, Temp
    • electrical safety test

Storage

  • Storage temperature -20°C to + 60°C
  • Air pressure 120 hPa to 805 hPa
  • Relative humidity: 10 to 95%

Waste management

Follow MSF GDPR, IPC and Watsan recommendations for disinfection and recyling of electronic waste

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