Ihealth bp5 [14/17] Electromagnetic compatibility information
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14
IEC 60601-1-2:2007 (Medical electrical equipment – Part 1: General
requirements for safety; Collateral Standard-Electromagnetic
compatibility - Requirements and tests);
EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers
- Part 1: General requirements);
EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers
- Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems);
ANSI/AAMI SP-10:2002+A1: 2003+A2:2006;
AAMI/ANSI 80601-2-30: 2009/IEC 80601-2-30: 2009+Cor.2010/EN
80601-2-30:2010(Medical electrical equipment –Part 2-30: Particular
requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers).
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below.
The customer or the user of the MONITOR should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Wireless Blood Pressure Monitor uses RF
energy only for its internal function.
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The MONITOR is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Complies
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the Wireless Blood Pressure
Monitor should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601test
level
Compliance level
Electromagnetic environment -
guidance
Electrostat ± 6 kV contact ± 6 kV contact Floors should be wood,
Содержание
- Body posture sitting comfortably during measurement a be seated with your feet flat on the floor without crossing your legs b place your hand palm side up in front of you on a flat surface such as a desk or a table c the middle of the cuff should be at the level of the right atrium of your heart 4
- Connect to ios device via bluetooth 4
- Measurement procedures blood pressure can be affected by the position of the cuff and your physiologic condition it is very important that the cuff should be placed at the same level as your heart 4
- Monitor status bluetooth indicator 4
- Battery handling and usage 9
- Do not change the battery if the battery can no longer be charged please contact customer service 9
- Do not plug or unplug the power cord into the electrical outlet with wet hands 9
- Do not pull out the adapter when you are using the monitor 9
- Do not use any other type of ac adapter as it may harm the monitor 9
- If the ac adapter is abnormal please change the adapter 9
- Lithium battery replacement by inadequately trained personnel could result in a hazard such as a fire or explosion 9
- Monitor status status indicator charging flashing green light fully charged steady green light low battery flashing red light for a few seconds abnormal state steady red light 9
- Overcharging the battery may reduce its lifetime 9
- Problem possible cause solution 9
- The monitor cable battery and cuff must be disposed of according to local regulations at the end of their usage 9
- Troubleshooting 9
- Electromagnetic compatibility information 14
- Iec 60601 1 2 2007 medical electrical equipment part 1 general requirements for safety collateral standard electromagnetic compatibility requirements and tests en 1060 1 1995 a1 2002 a2 2009 non invasive sphygmomanometers part 1 general requirements en 1060 3 1997 a1 2005 a2 2009 non invasive sphygmomanometers part 3 supplementary requirements for electro mechanical blood pressure measuring systems ansi aami sp 10 2002 a1 2003 a2 2006 aami ansi 80601 2 30 2009 iec 80601 2 30 2009 cor 010 en 80601 2 30 2010 medical electrical equipment part 2 30 particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers 14
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