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HAND-HELD ULTRASOUND (Lumify) + probes S4-1, L12-4

https://unicat.msf.org/cat/product/81021
NST EDIMULSE5F-

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.
Z11040106 - Handheld ultrasound scanners
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PMF
The order of this product needs to be justified and is only acceptable under certain conditions.
SC subscriptions: included in supply or field tools
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)
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HAND-HELD ULTRASOUND (Lumify) + probes S4-1, L12-4

The technical specifications are in the process of being defined. For more information, contact the Diagnostic Imaging Working Group (diagnostic.network@amsterdam.msf.org).

Definition

The Philips Lumify is a portable handheld ultrasound device used to visualize internal body structures. Clinical uses include lung, cardiac, abdominal, pelvic, musculoskeletal, vascular (including venous access), nerve, soft tissue, and superficial imaging.

Specifications

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Components

The following accessproes are included in EDIMULSE5A-

  • 1 Lumify L12-4 Linear Array Transducer (Lung, Musculoskeletal, Soft Tissue, Superficial, Vascular)
  • 1 Lumify S4-1 Broadband Sector Array Transducer (Abdomen, Cardiac, FAST, Lung, OB/GYN)
  • 1 Samsung Galaxy S7 10.5'' tablet 5 year warranty
  • 1 Samsung Galaxy S7 10.5'' tablet cover
Image

Technical specifications

  • Imaging features
    • 2D
    • Colour Doppler
    • M-mode
    • advanced XRES and multivariate harmonic imaging
    • SonoCT
  • The images and clips stored in the compatible smartphone or tablet can be exported via WiFi in DICOM format to a PACS, to a shared disk or by email in formatpng / mpeg.
  • MicroB USB transducers with replaceable cable
  • L12-4 Linear array transducer
    • Bandwidth: 12-4 MHz
    • Field of view: 34.5 mm
    • Footprint: 34 mm
    • Scan depth: up to 12 cm
    • Applications: Lung, MSK, Soft Tissue, Superficial, Vascular
    • Centre line marker
  • S4-1 Broadband sector array transducer
    • Bandwidth: 4-1 MHz
    • Field of view 90°
    • Footprint: 20.2 mm
    • Scan depth: up to 30 cm
    • Applications: Abdomen, Cardiac, FAST, Lung, OB/GYN
    • Centre line marker

Instructions for use

Maintenance

The transducer is not autoclavable.

After each examination, the transducer must be cleaned and disinfected with a detergent-disinfectant solution for medical equipment (either 25 ml = 1 stroke of dosing pump for 5 liters of water).

(Cf Introduction: Disinfection and sterilization in the field)

Storage

  • Temperature +10°C - +40°C
  • Relative humidity: 15 - 95 %
  • Atmospheric pressure: 700 - 1050 hPa

MSF requirements

This high-resolution ultrasound system offers similar performance features as larger cart-based systems in a portable, handheld, stand-alone unit.

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