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(US Edge 2) TRANSDUCER SUPERFICIAL STRUCT.HFL38xi,armored c

https://unicat.msf.org/cat/product/88000
STD EDIMULSA803

Valid Article

Z11040201 - Transcutaneous ultrasound probes
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
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) PROBES

Image

Definition

A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated).

Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

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

  • Transducers with armored cables
    • C60xi ref. P21636
    • HFL38xi ref. P20377
    • rP19x ref P21556

Technical specifications

Broadband and Multifrequency probe:

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

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

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

Additional transducers are most likely required.

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.

SonoSite Code

MSF code

ApplicationBand widthScan Depth

rC60xi

EDIMULSA802

General abdominal, MSK

General & 3rd Trimester OB/Gyn

5-2 MHz

Curved array

30 cm

ICTx

EDIMULSA407

1st trimester or advanced OB/Gyn

8-5 MHz

Tightly curved array

13 cm

HFL38xi

EDIMULSA803

Lung, MSK, Paediatrics

Nerve / Small parts / Vascular

13-6 MHz

Linear array

(High frequency)

6 cm

rP19x

EDIMULSA804

General abdominal

Lung, Cardiac

Paediatrics incl. cranial

5-1 MHz

Phased array

35 cm

Each additional transducer costs approx. €2,500.

* Specific training, transducer cover and strict disinfection protocols are required when using this transducer !

To be Ordered Separately

Recommended additional orders

MSF code

Item

Notes

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

*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.

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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Storage

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

MSF requirements

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

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