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ULTRASOUND (Sonosite Edge 2)+TRANSDUCER rC60xi, armored c.EN

https://unicat.msf.org/cat/product/96062
STD EDIMULSE8E-

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.
Z11040104 - Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
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
M
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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ULTRASOUND (Sonosite Edge 2)

Definition

Ultrasound-based diagnostic imaging apparatus used to visualize subcutaneous body structures. High image quality for abdominal, nerve, vascular, cardiac, venous access, pelvic and superficial imaging.

Specifications

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Quality standards

EN 60601-2-37, 2008, +A1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Components

  • Ultrasound machine L21822
  • Transducers with armored cables
    • C60xi ref. P21636
    • HFL38xi ref. P20377
    • rP19x ref P21556
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Technical specifications

ULTRASOUND SYSTEM

  • All-digital broadband architecture
  • Viewing angles: 85 degrees up/down/left/right
  • User interface and remappable controls:
    • Softkeys to drive advanced features
    • Programmable A and B keys
    • Low profile keyboard, sealed completely to edge for maximum infection control
    • Track pad with select key for easy operation and navigation
    • Doppler controls: angle, steer, scale, baseline, gain and volume
    • Image acquisition keys: review, report, Clip Store, save
    • Dynamic range: up to 165 dB
    • Gray Scale: 256 shades
    • Dedicated Auto Gain and examination keys to allow quick activation
    • Color : size/position, angle, scale, baseline and invertcontrols
  • Display: LCD, 12.1" (30.7 cm), NTSC or PAL with chemically etched glass layer
  • Power supply:
    • System operates via battery or AC power
    • Rechargeable lithium-ion battery < 100 Wh.
    • AC: universal power adapter, 100-240 VAC,
    • 50/60 Hz input, 15 VDC output
  • Weight: 4.18 kg with battery

IMAGING MODES

  • 2D / Tissue Harmonic Imaging / M-Mode
  • Velocity Colour Doppler / Colour Power Doppler
  • PW, PW Tissue Doppler and CW
  • Doppler angle, correct after freeze

IMAGING PROCESSING

  • SonoADAPT Tissue Optimisation
  • SonoHD2 Imaging Technology
  • Dual Imaging, Duplex Imaging, 2x pan/zoom capability, Dynamic range and gain
  • ColorHD Technology

TRANSDUCER / PROBE

Broadband and Multifrequency:

  • DirectClear Technology (rC60xi, rP19x)
  • Armored Cable Technology (Optional on rC60xi, rP19x, L38xi, L52x)
  • Linear Array, Curved Array, Phased Array, Multiplane TEE and Micro-Convex
  • Center line marker for linear transducers

Examination types:

  • abdominal, breast, cardiology, gyn, lung, musculoskeletal, neonatal, nerve, ob, ophthalmic, orbital, small parts, spine, superficial, TCD, arterial, venous

Armored cables with an embedded metal jacket, protect your transducers by safeguarding electrical connections inside.

CONNECTIVITY

  • S-video (in/out) to VCR or DVD for record and playback
  • RGB or DVI output to external LCD display
  • Composite video output (NTSC/PAL) to VCR or DVD, video printer or external LCD display
  • Audio output
  • Integrated speakers
  • EtherNet or wireless image/data transfer
  • USB ports
  • RS-232 transfer

ONBOARD IMAGE AND CLIP REVIEW

  • 16GB internal flash memory storage capability
  • Storage support for up to 500 patients
  • Clip Store capability (maximum single clip length: 60 seconds)
  • Clip Store capability via either number of heart cycles (using the ECG) or time base. Maximum storage in ECG beats mode is 10 heart cycles. Maximum storage in time base mode is 60 seconds
  • Start/Stop toggle capability for clips
  • USB Auto Export
  • Encryption of patient data on system
  • Cine review up to 255 frame-by-frame images

CONNECTIVITY (EXTERNAL DATA MANAGEMENT)

  • SonoSite Patient Data Archival Software (PDAS) for Wireless/Wired Image, Report Management
  • Q-path ultrasound management system
  • DICOM® Image Management (TCP/IP): Print and Store, Modality Work List, Storage Commit: Modality, Perform, Procedure Step
  • PC Workstation Image Management (TCP/IP, USB): Direct writing capability to USB 2.0 mass storage removable media (PC and MAC compatible)
  • Supported export formats: MPEG-4 (H.264), JPEG, BMP, and HTML

CONNECTIVITY (SYSTEM PORTS)

Ports, External Video/Audio:

  • USB ports (2)
  • ECG input (1)
  • Integrated Speakers

Dimensions

32.6 cm L x 30.7 cm W x 6.4 cm H

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

  • Battery (2 hours scanning time) P15051
  • International power cord
  • Transducers‌ with armored cables
    • EDIMULSE8--: curved array transducer rC60xi/5-2 MHz curved array transducer, biopsy compatible P21636
    • EDIMULSE8B-:
      • curved array transducer rC60xi P21636
      • superficial structures transducer HFL38xi P20377
      • cardiac transducer rP19x P21556
  • Advanced Gynaecology/Obstetrics Calculations P21604
  • Sonosite EDGE II Colour Application Pack P21593
  • Carry case P03673
  • Power supply L09823
  • Bottle of acoustic gel
  • User manual and service guides (several languages)
  • 5-year warranty

To be Ordered Separately

Having the correct transducer(s) available is CRUCIAL for performing Ultrasound examinations.

Additional transducers are most likely required. See Edge 2 Ultrasound Probes (accessories).

Transducer needs vary by project site. To order the most suitable transducers for your site, please contact POCUS@msf.org or the POCUS advisor for your section for further advice.

Consider ordering a backup of the transducer the project uses most frequently.

Recommended additional orders

MSF code

Item

Notes

EDIMULSS206

Charger L09823+ Power Cord - EU P00864

2-prong “EU” plug – Recommend 1 backup depending on plug type

EDIMULSS207

Charger L09823+ Power Cord - UK P07444

3-prong “UK” plug – Recommend 1 backup depending on plug type

EDIMULSS801

Battery - ultrasound

Recommend 1 backup

EDIMULSC1CA*

Ultrasound Gel, 250 ml bot.)

Consumption: 1 bottle = 10 exams, order min 40/month

SDISMDQA1T5**

Disinfection DETERGENT/DISINFECTANT for med. equip. 5 L tin + dosing pump

Diluted solution needed for daily IPC

PELEVOLL207T***

Voltage Protection - VOLTAGE LIMITER with timer, 180-265V, 7A, EUR, for fridge

For voltage stabilization, if needed

*Ultrasound exams are not possible without gel! Please order months in advance, and recommend ordering more than necessary until exact usage/month is well known. This gel has a long shelf-life with no temperature requirements. NEVER use alcohol or oil based products (Sterilium, povidone-iodine, alcohol gel, gel cleansers) as these may damage the transducer. Sterile lubrication or plain WATER may be used as alternatives.

**Only 0.5% Anios Clean diluted solution, made fresh daily, should be used to clean transducers. This is required after EVERY patient exam. Surfanios is NOT approved as a cleaning solution and may damage the transducers. NEVER use alcohol or oil based products (Sterilium, povidone-iodine, alcohol gel, gel cleansers) as these may damage the transducer.

*** Only necessary if the electrical network is NOT already protected by MSF standard double-conversion UPS

Instructions for use

If gel is not readily available, it can be replaced with water. Never use alcohol, oil or any other fluids as they can damage the transducer.

If a patient shows infectious lesions, the end of the transducer must be covered with a male condom or glove during the examination.

For advanced obstetric applications, a vaginal transducer (ICT x/ 8-5MHz) can be ordered separately (see accessories). This transducer is intended for trained and experienced users. It must always be used with a male condom.

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Precautions for Use

It is mandatory to protect the device with a double conversion UPS, and a voltage limiter with timer (see related articles below)

Storage

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

MSF requirements

This high-resolution ultrasound system offers such performance features as larger cart-based systems in a hand-carried, stand-alone unit.

Alternative to the MSF standard Sonosite M-turbo.

  • The Edge 2 is Sonosite's newer version of the M-turbo. The M-turbo was introduced in 2007 while the Edge 2 was introduced in 2016.
  • The performance and image quality of the Edge 2 are very similar to the M-turbo but it has an even sturdier design and features newer technology.
  • The interface and functionality of the Edge 2 is very similar to the M-turbo and in our experience, most MSF users are quite satisfied with the M-turbo. Users who are already accustomed to the M-turbo will adapt very quickly to the Edge 2.

5-year warranty on ultrasound system and transducers and excellent technical and customer service support from Sonosite

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