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Handheld breast ultrasound - 1002008

Product ID: ITM-1002008
generic
General Description: Ultrasound Breast ultrasound is an imaging technique that uses sound waves to create images of breast tissue.

Product Description
Linear Ultrasound Scanner
Enjoy superior imaging to 11cm in our most versatile linear scanner.
✓ High-Definition wireless ultrasound
✓ Easy-to-use app for iOS and Android
✓ Steadfast wireless connection
Applications: Breast, Lung, MSK, Ocular, Small Parts, Vascular [Included]
✓ B-Mode
✓ Colour Doppler
✓ M-Mode ✓
1 hour personal training
[Options]
- DICOM
- Needle Enhance
- Pulsed-Wave Doppler
- Elastography

Intended purpose
Breast ultrasound is an imaging test that uses sound waves to look at the inside of your breasts. It can help your healthcare provider find breast problems. It also lets your healthcare provider see how well blood is flowing to areas in your breasts.

Supplied with
Battery life for hand-held ultrasound system several hours .
They define the type of image that will be displayed. The most common ultrasound
modes and their applications are as follows:
A-mode: this is the simplest type of ultrasound. No image will be displayed on the screen, only a one-dimensional representation of reflected sound waves.
This mode is used for measuring distances.
B-mode (of 2B mode): linear array transducers simultaneously scan a plane through the body that can be seen as a 2D image on the screen. This is the most commonly used mode in various displines.
M-mode: this consists in a fast B-mode scanning sequence with successive images on the screen allowing doctors to see and measure the amplitude of movements (the perimeters of the organs producing the reflections move in relation to the transducer) Doppler mode: this mode allows you to visualize and analyse blood flow, vascularization, of even the direction of flow if the Doppler is in colour.
This mode is used in cardiology to analyse the condition of heart valves of the vascularization of certain tissue. Elastography mode: with this mode it is possible to measure the hardness of tissue and to diagnose, for example, a potential hepatic fibrosis. 3D and real-time 3D (4D) mode: this mode is used during ultrasound examinations of pregnant women to obtain a three-dimensional image of the fetes and observe its movements in utero. But the risks to the fetes are not negligible (see question 2). WIFI type : 802.11n/5G/450Mbps.
Working system : iOS/Android /Windows. Charging mode : USB charging of
wireless charging. Android phone brand : SUMSUNG, HUAWEI, HTC, SONY, Google Nexus, MI.

Instruction for use
The ultrasound system should be used far away from the strong electromagnetic
field (e.g. transformer). Otherwise, the system will be disturbed The ultrasound
system should be used far away from high-frequency radioactive device
(e.g. mobile phone). Otherwise, the system will get damaged of be affected.

Regulatory & Conformity Requirements
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.


US FDA 510(K) clearance

CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016

Classification:
Classified under EU MDR 2017/745 as Class IIb device



Pack SizeAvg. Price
Pack of 1$2,821.90