B.Braun Dialog+ SW 9 Serie Manual Del Usuario página 61

Supplement ABPM Automatic Blood Pressure Measurement Module
YOU WILL NEED ONE COPY PER MACHINE. PLEASE COPY IF NECESSARY.
US Supplement to Dialog
handling of old/new cuffs.
Read the following information and instruct all users in your organization. Add this
supplement to your Instructions for Use (IFU).
This supplement only contains information that is changed. For the complete
descriptions, refer to the existing Dialog Instructions for Use.
Symbols on ABPM Cuff
Symbol Description
Follow operating instructions when operating the ABPM
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance; Reference number D.1 – 11
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
Classification acc. to IEC 60601-1
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance; Reference number D.1 - 26
Cuff is not made with natural rubber latex
ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and
information to be supplied - Part 1: General requirements; Reference number 5.4.5; Annex B.2
Upper arm diameter
Cuff size: S (small), M (medium), L (large), XL(extra large)
The respective size is indicated by the rectangle around the symbol.
Marking for cuff placement
Marking for correct cuff size
Reference number
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labeling and
information to be supplied — Part 1: General requirements; Reference number 5.1.6; Table 1
Patient name
ISO/FDIS 15223-1:2020 Medical devices — Symbols to be used with medical device labels, labeling
and information to be supplied — Part 1: General requirements; Reference number 5.7.2; Table 1
Medical device
ISO/FDIS 15223-1:2020 Symbols to be used with medical device labels, labeling and information to
be supplied — Part 1: General requirements; Reference number 5.7.7; Table 1
Cuff side to be applied to the patient
CE marking
Council directive 93/42/EEC concerning medical devices; Annex XII
Manufacturer
ISO 15223-1:2016 Symbols to be used with medical device labels, labeling and information to be
supplied — Part 1: General requirements; Reference number 5.1.1; Table 1
Supplement 38910556 / Rev. 2.87.40 / April 2021
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Instructions for Use (IFU): Information about the option ABPM and
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