Warning; Chapter 1 Safety Guidance; Safety Precautions - EDAN INSTRUMENTS SONOTRAX Serie Manual Del Usuario

Chapter 6 Maintenance ...........................................................................................................28
6.1 Maintenance ..................................................................................................................28
6.2 Cleaning ........................................................................................................................28
6.3 Disinfection ...................................................................................................................29
Chapter 7 Warranty and Service............................................................................................30
Appendix A EMC Information-Guidance and Manufacture's Declaration.......................31
A1.1 Electromagnetic Emissions - for all Equipment and Systems....................................31
A1.2 Electromagnetic Immunity - for all Equipment and Systems ....................................31
A1.3 Electromagnetic Immunity - for all Equipment and Systems that are not
Life-supporting....................................................................................................................32
A1.4 Recommended Separation Distances .........................................................................33
Appendix 2 Overall Sensitivity................................................................................................34
IV
SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Chapter 1 Safety Guidance

This unit is internally powered equipment, and the degree of shock protection is type B.
Type B protection means that these person connections will comply with permitted leakage
currents, dielectric strengths of IEC 60601-1.

1.1 Safety Precautions

WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.

WARNING

: This device is not explosion-proof and can not be used in the
presence of flammable anaesthetics.
WARNING : Do not throw batteries in fire as this may cause them to explode.
WARNING : Do not attempt to charge normal alkaline batteries, they may leak,
and may cause a fire or even explode.
WARNING : Charge the lithium-ion polymer battery with the special charger
supplied by EDAN.
WARNING : Don't touch signal input or output connector and the person
simultaneously.
WARNING : Accessory equipment connected to the analog and digital interfaces
must be certified according to the respective IEC standards (e.g.
IEC 950 for data processing equipment and IEC 60601-1 for
medical equipment). Furthermore all configurations shall comply
with the valid version of the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input
connector or signal output connector configures a medical system,
and is therefore responsible that the system complies with the
requirements of the valid version of the system standard IEC
60601-1-1. If in doubt, consult our technical service department or
your local distributor.
WARNING : SONOTRAX Series Ultrasonic Pocket Doppler is a tool to aid the
healthcare professional and should not be used in place of normal
fetal monitoring.
WARNING : We recommend that exposure to ultrasound should be kept as low
as reasonably achievable. This is considered to be good practice
and should be observed at all time.
WARNING : Replacing battery shall only be done outside the personnel
environment (1.5m away from the personnel).
WARNING : Please use probes provided by EDAN.
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