SHENZHEN PUMP MEDICAL SYSTEM CO. LTD. BFW01 Manual De Usuario

Rev. A1

Normal

120-129 and/or

80-84

Pre hypertension

130-139 and/or

85-89

Hypertension：

≥140 and/or

≥90

Stage 1 Hypertension

140-159 and/or

90-99

Stage 2 Hypertension

160-179 and/or

100-109

≥180 and/or

≥110

These categories were defined by the American Heart Association. This chart applies to adults
age 20 and older.

8.3 What is Morning Hypertension (Morning Surge)?

Morning high blood pressure or morning surge is defined as the weekly average for morning

blood pressure reading measured within 1 hour to 2 hours after awakening in the morning and

exceeding 135/85mm Hg. Studies have shown that exaggerated morning blood pressure surge is a

risk for cardiovascular events which includes ischemic and hemorrhagic stroke. Cardiovascular

events have been shown to be exaggerated in the morning to coincide with morning high blood

pressure. In fact heart attack, stroke and heart failure have been shown to fall particularly on a

Monday amongst all the other days of the week.

Organ damage and diabetic complications have also been shown to be linked with morning blood

pressure surges just in the same way as small artery disease and multiple celebral infarcts in elder

members of society. Morning high blood pressure has shown some correlation with initial stage

and progression of atherosclerosis. Patients with well controlled blood pressure may still have

high morning blood pressure and this happens in 50% of the cases. Patients with morning

hypertension have a 78% more chance of stroke compared with 48% of other hypertensive

patients without morning high blood pressure. Morning hypertension has also been associated

with changes in heart size and rhythm. This may lead to heart attack or heart failure.

Morning Hypertension can only detect within 1 hour to 2 hours after awakening, recommended

user monitor their own blood pressure at home.

Reference Standard

·IEC 60601-1: 2005 Medical electrical equipment-Part1: General requirements for safety and

essential performance.

·IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic compatibility –

Requirements and tests
· IEC80601-2-30 ： 2009+A1 ： 2013 Medical electrical equipment – Part 2-30: Particular

requirements for the basic safety and essential performance of automated non-invasive

sphygmomanometers.
·ANSI/AAMI/ISO 81060-2-2009 Non-invasive sphygmomanometers-Part 2:Clinical validation of

automated measurement type