User Manual
Spirostik
SPIROSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 7
2.2.1.1
Norms and Guidelines
The Geratherm Respiratory products are manufactured in accordance
with DIN EN ISO 13485. According to the European directive
93/42/EEC, Spirostik fulfils the requirements of annex II.
In addition the following norms are fulfilled:
- DIN EN 60601-1 (Medical electrical device)
- DIN EN 60601-1-1 (General safety requirements)
- DIN EN 60601-1-2 (EMV)
- DIN EN 60601-1-4 (Programmable electrical medical devices)
- DIN EN ISO 14971 (Risk management)
- DIN EN ISO 23747 (Peak Flow devices)
2.2.1.2
Electromagnetic Compatibility
Strong radio transmitters should not be used close to the device.
Do not use mobile phones and cordless phones close to the device.
There may be an influence to medical devices.
The interference resistance is 3V/m. Do not use a higher level close
to the Spirostik.
