Product Manual

ManualsBrandsGE ManualsDiagnosticsVscan Air Handheld Ultrasound Scanner

Safety Conformance

Safety classication

Vscan Air CL probe is classied as internally powered

medical electrical equipment with type BF applied parts

according to IEC 60601-1

Vscan Air CL probe is CE-marked according to MDD

(93/43/EEC), RED (2014/53/EU), RoHS (2011/65/EU), and is

compliant to 2012/19/EU (WEEE)

Vscan Air for Android and Vscan Air for iOS are CE-marked

according to MDD (93/42/EEC)

Vscan Air CL probe is NRTL Certied to CAN/CSA-C22.2

No. 60601-1 and ANSI/AAMI ES60601-1.

Wireless charger pad of Vscan Air is certied according to

IEC/EN62368-1 and/or IEC/UL/cUL60950-1

Vscan Air conforms to applicable clauses of the following

safety standards:

IEC 60601-1

Medical electrical equipment –

Part 1: General requirements for basic

safety and essential performance

IEC 60601-1-2

Medical electrical equipment –

Part 1-2: General requirements for basic

safety and essential performance –

Collateral Standard: Electromagnetic

disturbances – Requirements and tests.

(Group One, Class B per CISPR 11 / EN

55011)

IEC 60601-2-37 Medical electrical equipment –

Part 2-37: Particular requirements

for the basic safety and essential

performance of ultrasonic medical

diagnostic and monitoring equipment

IEC 60601-1-11 Medical electrical equipment –

Part 1-11: General requirements for

basic safety and essential performance –

Collateral Standard: Requirements

for medical electrical equipment and

medical electrical systems used in the

home healthcare environment

IEC 60601-1-12 Medical electrical equipment –

Part 1-12: General requirements for

basic safety and essential performance –

Collateral Standard: Requirements

for medical electrical equipment and

medical electrical systems intended for

use in the emergency medical services

environment

EN 13718-1 Medical vehicles and their equipment –

Air ambulances

Part 1: Requirements for medical devices

used in air ambulances

EN 1789 Medical vehicles and their equipment –

Road ambulances

ISO 10993-1

vii

Biological evaluation of medical devices

Part 1: Evaluation and testing within a

risk management process

IEC62304 Medical device software – Software life

cycle processes.

IEC62366-1 Medical devices – Part 1: Application of

usability engineering to medical devices