GERATHERM desktop - Quality Standard; Symbol Index

38
EN
Quality Standard
Geratherm
®
is certifi ed in accordance with Council Direc-
tive 93/42/EEC and EN ISO 13485 and is entitled to affi x
the CE-mark 0197 (Notifi ed Body: TÜV Rheinland LGA
Products GmbH).
The blood pressure monitor conforms to
• EN 60601-1 +A1 Medical electrical equipment. Part 1:
General requirements for basic safety and essential
performance.
• IEC/EN 60601-1-11 Medical electrical equipment. Part
1-11: General requirements for basic safety and essen-
tial performance - Collateral standard: Requirements
for medical electrical equipment and medical electrical
systems used in the home healthcare environment.
• DIN EN ISO 81060-1
Non-invasive sphygmomanometers – Part 1: Require-
ments and test methods for non-automated measure-
ment type (ISO 81060-1)
• DIN EN ISO 81060-2
Non-invasive sphygmomanometers – Part 2: Clinical
investigation of automated measurement type (ISO
81060-2)
• EN 1060-3
Non-invasive sphygmomanometers – Part 3: Supple-
mentary requirements for electro-mechanical blood
pressure measuring systems
Symbol index
Follow the instruc-
tions for use
Type BF Equipment
Keep dry
Batch code
(mm/yyyy; month/year)
Store between 15 %
and 90 % R.H.
Serial number
Store between
-25 °C and +55 °C
Manufacturer
The device must not
be disposed of with
household waste.
Important! Read the
instruction manual!
SN
90%
-25°C
+55°C
15%