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  3. MONITOR (Mindray VS8) main unit +8"HD screen DJ10-0001-313
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MONITOR (Mindray VS8) main unit +8"HD screen DJ10-0001-313

https://unicat.msf.org/cat/product/96643
STD EEMDMONE2200

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.
Z1203020201 - Multi–parameter patient bedside monitors
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
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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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.

The apparatus is used for occasional or periodic readings of vital signs and/or continuous monitoring of SpO2, HR, and intermittent automatic BP in healthcare settings such as: emergency departments, general or specialized inpatient wards, intensive care unit." It is important for our Ops colleagues to know that this is the device we recommend for basic ICU-level 1 for continuous monitoring.

It is not only a a spot-check device. The device will the the MSF standard device we recommended for the basic critical care/ICU- level 1. The more advanced ePM10 or ePM12 multi-parameter monitor are meant for intermediate and advanced critical care (level 2 and 3), as they have more implications financially and training perspective.

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

EEMDMONP22- and EEMDMONE2200 are composed of

  • 1 x Main unit with 8" HD Non-touch screen (with knob) DJ10-0001-313
  • 1 x English language software DJ10-0005-002
  • 1 x EEMDMONS2201 Power cord - EU (European) DJ10-0002-002
  • 1 x EEMDMONS2202 High Capacity Battery DJ10-0021-030
  • 1 x built in NIBP with TrueBP technology DJ10-1003-001
  • 1 x Multifunctional Connectors (Nurse Call/DIAP/Battery port) DJ10-1021-008
  • 1 x built in Nellcor SpO2 DJ10-1002-003

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

Supplied with the Article

Only EEMDMONP22- package is supplied with

  • 1 x EEMDMONA2202 Rolling Stand (Standard) + comment Quick lock (compact with all existing models under 12" inch screen and VS) - 045-004267-00
  • 1 x EEMDMONA1601 SpO2 Connection cable, 7-pins - 0010-20-42710
  • EEMDMONA2315 SpO2 SENSOR neo, adu/ped reusable 518B
  • EEMDMONA2314 SpO2 SENSOR adu/ped ear-clip reusable 513A
  • EEMDMONA2313 SpO2 SENSOR child finger-tip reusable 512G
  • EEMDMONA2312 SpO2 SENSOR adu finger-tip reusable 512E
  • 2 x EEMDDEFA205 NIBP Tubing, Adu/Ped/Infant, with air plug connectors (3m) - 6200-30-09688
  • 3 x EEMDMONA2301 CM1300 reusable cuff, neonate 7-13cm with connector - 040-000968-00
  • 5 x EEMDMONA2302 CM1301 resuable cuff, Infant, 10-19 cm, with connector - 040-000973-00
  • 5 x EEMDMONA2304 CM1303 resuable cuff, Adu, 25-35cm, with connector - 040-000983-00
  • 5 x EEMDMONA2305 CM1304 resuable cuff, Large Adu, 33-47cm, with connector - 040-000988-00
  • 3 x EEMDMONA2306 resuable cuff, adult thigh 46-66cm, with connector - 040-000993-00

To be Ordered Separately

For EEMDMONE22-

  • EEMDMONA2202 Rolling Stand (Standard) + comment Quick lock (compact with all existing models under 12" inch screen and VS) - 045-004267-00
  • EEMDMONA2301 CM1300 reusable cuff, neonate 7-13cm with connector - 040-000968-00
  • EEMDMONA2302 CM1301 resuable cuff, Infant, 10-19 cm, with connector - 040-000973-00
  • EEMDMONA2304 CM1303 resuable cuff, Adu, 25-35cm,with connector - 040-000983-00
  • EEMDMONA2305 CM1304 resuable cuff, Large Adu, 33-47cm,with connector - 040-000988-00
  • EEMDMONA2306 resuable cuff, adult thigh 46-66cm, with connector - 040-000993-00
  • EEMDMONA2307Nellcor cable+Neo Sensor - 0651-30-77023
  • EEMDMONA203 DS100A reusable sensor, Adu - 9000-10-05161
  • EEMDDEFA205 NIBP Tubing, Adu/Ped/Infant, with air plug connectors (3m) - 6200-30-09688
  • EEMDPOXC102 Nellcor reusable SpO2 sensor, Adu/Neo, with 50pcs bandage - 9000-10-07336

For EEMDMONP22- and EEMDMONE2200

  • EEMDMONC2314 CM1500B single patient cuff neonate 4.3-8.0cm
  • EEMDMONC2317 CM1500E single patient cuff neonate 8-15cm
  • EEMDMONC2318 CM1501 single patient cuff infant 10-19cm
  • EEMDMONC2319 CM1502 single patient cuff child 18-26cm
  • EEMDMONC2320 CM1503 single patient cuffadult 25-35c
  • EEMDMONC2321 CM1504 single patient cuff large adult 33-47cm
  • EEMDMONC2322 CM1505 single patient cuff adult thigh 46-66cm

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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