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MONITOR NIBP (Dinamap Carescape V100)

https://unicat.msf.org/cat/product/12823
STD EEMDMONE2--

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Former Code(s): EHOEMONI2--
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.
Z1203020202 - Transportable/portable multi–parameter patient 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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
UN2800
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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MONITOR NIBP (Dinamap Carescape V100)

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Definition

An assembly of devices designed for continuous assessment of several vital physiologic parameters of one patient: heart rate, oxygen saturation and blood pressure (diastolic and systolic) in a noninvasive manner, with adjustable alarms for these parameters.

The system is used to evaluate and observe trends in a compromised or unstable patient in intensive or general healthcare settings.

Specifications

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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

Components

  • 1 x Carescape DINAMAP monitor with a battery
  • 5 x EEMDMONA129: (Dinamap/B40/B125) CUFF CHILD, green 12-19cm, 2T-Dinaclick
  • 5 x EEMDMONA131: (Dinamap/B40/B125) CUFF ADULT M, navy 23-33cm,2T-Dinaclick
  • 5 x EEMDMONA132: (Dinamap/B40/B125) CUFF ADULT long,navy 23-33cm,2T-Dinaclick
  • 1 x EEMDMONA203: SENSOR SPO2 adult Nellcor DS100A
  • 1 x EEMDPOXC103 SENSOR SPO2, ped/inf. + adh.wrap OXI-P/I
  • 100 x EEMDPOXC104: ADHESIVE WRAPS for sensors, ADH-A/N
  • 1 x EEMDMONA102 CABLE interface for Nellcor probe 2021406-001
  • 2 x EEMDMONA201: TUBING NIBP adult/child 107363
  • 10 x EEMDMONA202: ADAPTOR QUICK CONNECT, 330091
  • 1 x EEMDMONA207: KIT Mobile TROLLEY with basket 2073250-002

Technical specifications

  • Parameters
    • Heart rate: min range 30-250 bpm, graduation 1bpm
    • SpO2: min range 70-99%
    • Non-invasive measurement of blood pressure = NIBP (systolic, diastolic and average): min range 30-270 mm Hg
  • Internal pump for cuff inflation for NIBP measurement, with overpressure protection
  • ​LCD Display
    • with numerical values visualisation
    • settable limits for the measured variables
    • all parameters can be shown
  • Adjustable alarm:
    • high and low level
    • for pulse, O2 saturation, blood pressure
  • Power supply mains 100-250V/50Hz (also available in 110V/60 Hz)
  • Internal replaceable rechargeable battery
    • Lead acid battery 6V 3.5Ah
    • Battery life
      • 8.1 hours with blood pressure measurements every 15 min with SpO2
      • 11.5 hours without SpO2
    • Charging time: 5 to 8 hours
  • Automatic switch between battery and mains powered mode when recharging or in mains power failure
  • Protection against electric shocks
    • Class II
    • Type BF
    • The monitor contains three fuses. They are mounted inside the monitor.
  • The adaptor sector contains a non-resettable and non replaceable fuse.
  • Environmental conditions:
    • Operating temperature: + 5°C to + 40°C
    • Operating air pressure: 700 hPa to 1060 hPa
    • Humidity range 5% to 95% noncondensing
  • ​Support: Stands alone on rubber stand or mounted on awheeled stand
  • Mobility: is carried by its built-in handle

Dimensions

H x L x W : 19.56cm x 21.9cm x 3.5cm

Weight: 2.4 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

The single patient multiple use cuffs are intended for context of viral haemorrhagic fevers.

Instructions for use

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Precautions for Use

Secure the electrical protection of the apparatus with a double conversion UPS (see related articles below).

Storage

  • Storage temperature -20°C to + 50°C
  • Air pressure 500 hPa to 1060 hPa
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