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PATIENT MONITORING SYSTEM + acc (Philips MX400 + MMS X3)

https://msf.oodin.sh/cat/product/77022
NST EEMDMONE80-

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
PM
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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PATIENT MONITORING SYSTEM + acc (Philips MX400 + MMS X3)

The new model replaces the EEMDMONE8--PATIENT MONITORING SYSTEM + acc (Philips MX400 + MMS X2) because the extension MMS x2 has been discontinued and replaced by MMS x3.

Definition

An assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient. It typically includes a central station monitor that receives, consolidates, and displays the information, and a bedside patient monitor; it often includes portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring of an ambulatory patient; it is not dedicated to neonatal or ambulatory use. The system is used to evaluate and observe trends in a compromised or unstable patient in intensive or general healthcare settings.

GMDN : Single-patient physiologic monitoring system (33586)

Specifications

The MX400 provides monitoring in a compact, transportable unit and designed to monitor a wide range of vital signs.

The MMS X3 is a transport monitor that's also a measurement module, offering continuity of patient data and transport across all levels of patient monitoring.

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Technical specifications

MX400:

  • 9"-wide touchscreen
  • The display automatically adjusts screen brightness
  • Built-in handle and battery operation
  • Measured parameters:
    • NIBP,
    • SpO2,
    • TEMP,
    • RESP,
    • ECG

MMS X

  • additional battery run time of up to six hours (11 Wh) for intra-hospital patient transport and concurrent CO₂ measurement with additional invasive blood pressure and temperature measurement.
  • colorful touchscreen with 3.5" display
  • Operating Voltage: 36 to 60 V DC floating
  • Cardiotach
    • Range
      • Adult/pedi: 15 to 300 bpm
      • Neo range: 15 to 350 bpm
  • PVC Rate
    • Range: 0 to 300 bpm
  • ST Numeric
    • Range: -20 to +20 mm
  • QT Numeric
    • Range: 200 to 800 ms
  • QTc Numeric
    • Range: 200 to 800 ms
  • ΔQTc Numeric
    • Range: -600 to +600 ms
  • QT-HR Numeric
    • Range - adult: 15 to 300 bpm
    • Range - pediatric and neonatal: 15 to 350 bpm
    • Sinus and SV Rhythm Ranges
  • Brady
    • Adult: 15 to 59 bpm
    • Pedi: 15 to 79 bpm
    • Neo: 15 to 89 bpm
  • Normal
    • Adult: 60 to 100 bpm
    • Pedi: 80 to 160 bpm
    • Neo: 90 to 180 bpm
  • Tachy
    • Adult: >100 bpm
    • Pedi: >160 bpm
    • Neo: >180 bpm

Dimensions

MMS X2:

  • Height: 9.9 cm
  • Width: 18.8 cm
  • Depth: 8.6 cm
  • Weight: 1.25 kg

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
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Instructions for use

Precautions for Use

  • Prohibited Environments: The monitors are not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).
  • Grounding: Remember that to avoid the risk of electric shock, the monitor must be grounded during operation. If a three-wire receptacle is not available, consult the hospital electrician. Never use a three-wire to twowire adapter.
  • Explosion Hazard: Do not use in the presence of flammable anesthetics or gases, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide. Use of the devices in such an environment may present an explosion hazard.
  • Reuse: Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard.

MSF requirements

Restricted to Ebola intervention

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Description approved by OCBA referent (Alicia Aglio) in July 2023.