Materiovigilance - Spengler Neotens Neo300 Gebrauchsanweisung

Cuff Circumference
Operating Environment
Storage and Transport Environment
Ingress Protection Rating
Classification
Specifications are subject to change without notice.
This blood pressure monitor complies with the European regulations and bears the CE mark "CE 0123".
This blood pressure monitor also complies with mainly following standards (included but not limited):
Safety standard:
EN 60601-1 Medical electrical equipment part 1: General requirements for basic safety and essential performance
EN 60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --
Collateral Standard: Electromagnetic Disturbances – Requirements And Tests
Performance standards:
IEC80601-2-30, Medical electrical equipment – Part 2-30:
Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.
ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

MATERIOVIGILANCE

Any serious incident occurring in connection with the device must be notified to the manufacturer and the competent author-
ity of the member state where the user is established.
Medium cuff (M/L): fits arm circumference of 22 to 42 cm
Temperature
Humidity
Pressure
Temperature
Humidity
IP 21, Indoor Use Only
Type BF equipment , Cuff is the Applied Part
USER MANUAL NEOTENS | WWW.SPENGLER.FR
5°C ~ 40°C (41°F~104°F)
15%~93%RH
700 hPa ~ 1060 hPa
-25°C ~70°C (-13°F~158°F)
≤93% RH
EN
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