Quality Standard; Symbol Index - GERATHERM desktop Instrucciones De Uso

Quality Standard

Geratherm
tive 93/42/EEC and EN ISO 13485 and is entitled to affi x
the CE-mark
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
EN
pressure measuring systems

Symbol index

90%
15%
+55°C
-25°C
is certifi ed in accordance with Council Direc-
®
0197 (Notifi ed Body: TÜV Rheinland LGA
Follow the instruc-
tions for use
Keep dry
Store between 15 %
and 90 % R.H.
Store between
-25 °C and +55 °C
The device must not
be disposed of with
household waste.
Type BF Equipment
Batch code
(mm/yyyy; month/year)
SN
Serial number
Manufacturer
Important! Read the
instruction manual!
38