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7. Specificaties
235
NL
Opmerkingen:
Deze specificaties kunnen zonder kennisgeving worden gewijzigd.
In de klinische validatiestudie is de vijfde fase gebruikt bij 85 personen voor het bepalen van de
diastolische bloeddruk.
Dit apparaat is klinisch onderzocht volgens de vereisten van ISO 81060-2:2013.
Dit apparaat is niet gevalideerd voor gebruik bij zwangere patiënten.
IP-classificatie is de mate van bescherming die de behuizing biedt in overeenstemming met IEC 60529.
Het apparaat en de optionele netadapter zijn beveiligd tegen vreemde vaste voorwerpen met een
diameter van 12,5 mm en groter zoals een vinger. De optionele netadapter (HHP-CM01) is beveiligd
tegen recht naar beneden vallende waterdruppels die problemen kunnen veroorzaken bij normaal
gebruik. Een andere optionele netadapter (HHP-BFH01) is beveiligd tegen schuin naar beneden vallende
waterdruppels die problemen kunnen veroorzaken bij normaal gebruik.
• Dit apparaat voldoet aan de voorwaarden van EG-Richtlijn 93/42/EEG betreffende medische
hulpmiddelen.
Dit apparaat is ontworpen volgens de Europese standaard EN1060, niet-invasieve
sfingomanometer deel 1: Algemene vereisten en deel 3: Aanvullende vereisten voor
elektromechanische bloeddrukmeetsystemen.
Dit OMRON-apparaat is vervaardigd conform het strenge kwaliteitssysteem van OMRON
HEALTHCARE Co., Ltd., Japan. De hoofdcomponent voor OMRON-apparaten, de
druksensor, wordt geproduceerd in Japan.
Gewicht Meter: circa 364 g zonder batterijen
Armmanchet: circa 170 g
Buitenafmetingen Meter: circa 114 (b) mm × 85 (h) mm × 139 (l) mm
Armmanchet: circa 145 mm × 594 mm
Omtrek manchet 22 tot 42 cm
Materiaal manchet/slang Nylon, polyester, polyvinylchloride
Inhoud van de verpakking Meter, armmanchet (HEM-RML31), gebruiksaanwijzing, opbergetui, set batterijen,
bloeddrukpas, instructies voor instellen
37


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  • Model HEM-7280T cant export data as a pdf file as I have previously done Submitted on 1-10-2022 at 05:41

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