package has been lost, the device should be packaged in a carton box with impact/vibration reducing materials such as air caps,
towels or crumpled paper. Do not use the device if has been stored or transported at its minimum or maximum storage temperature. If
stored or transported at -25 or 70° C let the device cool down or heat up, to reach its intended temperature range for use, in ambient
room temperature of +20° C for 45 minutes, before use and application.
18 Distributor and manufacturer contact information
Distributor: SYMBYX Pty Ltd. ABN 29638049073 Suite 6, 110-114 Hampden Lane, Artarmon NSW 2064 Australia.
Tel +61 (0)2 8066 9966
Email: info@symbyxbiome.com.
Manufacturer: Spectro Analytic Irradia AB. Fagerstagatan 9, 163 53 Spånga, Sweden Phone: +46-8-7672700, www.irradia.se.
For technical service and support, please contact the Distributor.
18.1 Reporting serious incidents
Any serious incident that has occurred in relation to the device should be reported by the user and/or patient to the manufacturer and
the competent authority of the Member State/Country in which the user and/or patient is established.
19 Electromagnetic compatibility (EMC)
The need for establishing the electromagnetic compatibility in standards is to ensure that the performance of Medical Electrical
Equipment, under certain conditions, is normal. Electromagnetic emission standards are essential for, inter alia, the protection of
safety services and other Medical Electrical Equipment and Systems, as well as telecommunications. Electromagnetic Immunity
Standards are used to ensure that the Medical Electrical Equipment performs satisfactorily within its intended environment. The
electromagnetic disturbance environment can occur in the shape of ambient temperature, humidity, and atmospheric pressure.
Medical Electrical Equipment and Systems may experience environmental conditions within the expected range of the interference
environment at any time, and for extended periods of time, without the operator being aware of the ambient levels on a continuous
basis.
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