2.3 Instructions for Environment Test
The environmental testing for the device should be in accordance with requirements of GB/T
14710-2009 (Medical electrical equipment environmental requirement and test method)
2.4 Sound Output
The device is in accordance with GB16846-2008 and the announcement exemption for the public in
chapter 6 of Requirement of medical ultrasound diagnosis device for its sound output (see Figure 2-
1).
Transducer frequency: 2.6MHz
Device is in accordance with requirements of GB9706.9-2008 -< Part 2-37 in Medical electrical
equipment : 51.2aa),dd) in requirements for particular safety of ultrasound diagnostic and monitoring
equipment> . Exempted from showing MI, TI. MI <1 TI<1
Fig 2-1 Technical Datasheet for
Level of Sound Output
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9
