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MONITOR, multiparameter (B125)+ accessories, 230V

https://unicat.msf.org/cat/product/80420
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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.
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
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).
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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Documents

  • MONITOR MULTIPARAMETER PROCARE B125 (Protocol II)

MONITOR multiparameter (B125)

Definition

Portable, vital signs monitor, used to provide continuous measurement of electrocardiogram, pulse oximetry and capnography, and discontinuous measurement of non-invasive blood pressure (NIBP).

This type of monitor is desirable for general ER and essential for advanced ER. It is also essential for any type of OT

The monitor Procare B40 V2 is no longer produced and replaced by the B125 of the same manufacturer GE Healthcare.

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
  • EN IEC 80601-2-30, 2019, edition 2, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
  • 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

Components

  • 1 x Monitor B125 v2 ATO Model 2099000-004
  • 1 x Monitor B125 v2 with ECG, SpO2 Nellcor, NIBP 2104310-003
  • 1 x System without IBP, English Label 2084022-032
  • 1 x B125 VSP 2 lang English 2104310-005
  • 1 x Extension rack for monitor B1x5 with space for module E 2104310-046
  • 1 x Power cable Europe 2064022-120
  • 1 x No network option 2099002-093
  • 1 x Supplementary lithium-ion battery 2099002-014
  • 1 x Plaque de fixation pour l'enregistreur thermique 2104310-054
  • 1 x Non-510K France Country Localization 2104210-047
  • 1 x E- MiniC-00 Single-width Airway Module, E-miniC-00 2099002-008
  • 2 x Gas Sampling Line, disposable, PVC/PE, 3m (10pcs), adult/ped 2097307-002
  • 2 x Mini D-fend Water Trap for M-miniC-00 (10pcs) 8002174
  • 1 x Câble ECG, 3/5 dérivations MultiLink IEC 3,6 m 2106305-003
  • 2 x Patient ECG cable multilink 3 grabbers 74cm 2106390-003
  • 1 x Interface cable for Nellcor OxiMax SpO2 3m 2021406-001
  • 2 x Sensor SpO2 adult reusable Nellcor DS100A 70124021
  • 1 x Sensor SpO2 child/infant reusable Nellcor OXI-P/I supplied with 50 adhesive strips OXI-P/I 414248-001
  • 2 x Nellcor Tape (2x50pcs) ADH-A/N 2016130-001
  • 2 x Dinaclick NIBP Airhose, 3.6m 2058203-002
  • 1 x DUR-P1-2A Dinalick Dura-Cuf Infant – Orange (5 pcs)
  • 1 x DUR-P2-2A Dinalick Dura-Cuf Child – Green (5 pcs)
  • 1 x DUR-A1-2A Dinalick Dura-Cuf Small Adult – Royal blue (5 pcs)
  • 1 x DUR-A2-2A Dinalick Dura-Cuf Adult – Marine blue (5 pcs)
  • 1 x DUR-A2-2A-L Dinalick Dura-Cuf Adult Long - Marine blue (5 pcs)
  • 1 x B1x5 v1.5 Training course 2104300-020
  • 1 x Training USB 2104310-065
  • 1x Temperature cable, single 0.5 m 2104178-001
  • 1x Central temperature sensor, child 3m2 107176-032
  • 1x Skin temperature sensor adult/child 3m 2107176-033

Technical specifications

  • Display (LCD screen):colour screen = 26.4 cm display
    • ECG graph (3 leads)
    • expired CO2 waveform in mmHg
    • values for SpO2 (%) and plethysmographic waveform
    • values for non-invasive blood pressure (systolic, diastolic, and mean pressures)
    • calculated heart rate, respiratory rate
  • Heart rate measurement
    • range minimum 30–250 bpm
    • accuracy better than ± 5 bpm
    • minimum gradation 1 bpm
  • SpO2 measurement
    • range minimum 70–99%
    • accuracy better than ± 3%
    • minimum gradation 1%
  • Blood pressure monitoring
    • range minimum 30–270 mm Hg
    • minimum gradation 1 mm Hg
  • Internal pump for cuff inflation for non-invasive blood pressure measurement, with over pressure protection
  • Automatic and programmable memory
  • Storage of continuous monitoring data
  • Adjustable alarms
    • high and low levels for each parameter: peripheral pulse rate, saturation, blood pressure, CO2, pulse and respiratory rates
    • Alarm override and temporary silence facility to be included
  • Power supply: 200-240 V/50 Hz (comes also in 110V/60 Hz) and Lithium-Ion rechargeable battery (4 h ; < 100 Wh)
  • Operating conditions
    • 0-40ºC, CO2 sensor 10-40ºC
    • Relative humidity 5-95% at 4ºC

Transport Dangerous Goods

  • UN3481 Lithium ion batteries contained in equipment
  • Class: 9
  • Packing Instructions: 967 Section II
  • The label must include the UN code of the battery + an emergency number to contact in case of an incident
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
Image

Supplied with the Article

  • ECG
    • 1x 3/5-lead ECG cable 3.6m EEMDMONA108
    • 2x 3-Lead ECG lead wires, grabbers, 74 cm EEMDMONA135
  • CAPNO
    • 1x CO2 sensor, sidestream E-miniC EEMDMONA301
    • 1x CO2 airway adapter adult/paediatric
  • SpO2
    • 1x SpO2 interface cable 3.6m EEMDMONA102
    • 2x reusable adult finger sensors DS100A EEMDMONA203
    • 1x reusable neonatal sensor OXI-P/I EEMDMONA204
    • 2x 100 adhesive tapes fr neonatal sensor ADH-A/N EEMDPOXC104
  • NIBP
    • 2x NIBP dual hoses Dinaclick EEMDMONA136
    • BP cuffs 2T-Dinaclick
      • 5 infant, orange EEMDMONA128
      • 5 paediatric, green EEMDMONA129
      • 5 small adult, blue EEMDMONA130
      • 5 adult, marine blue EEMDMONA131
      • 5 large adult, marine blue EEMDMONA132
  • Temperature
    • 1x temperature cable 0.5 m EEMDMONA103
    • 1x skin temperature probe Ø10mm, reusable EEMDMONA125
    • 1x temperature probe general use, Ø3mm, reusable EEMDMONA122

To be Ordered Separately

boxes of ECG electrodes

Instructions for use

Device intended for the monitoring of patients in peri-operative activity or intensive care.

This capnography system must always be used with a hydrophobic antibacterial filter.

Precautions for Use

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

MSF requirements

The pulse oximeter and the capnograph are part of the basic anaesthetic equipment of any operating theatre.

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