Andon Health BP7 Wireless blood pressure wrist monitor User Manual BP7 Owner s Manual 06 12 15
Andon Health Co., Ltd Wireless blood pressure wrist monitor BP7 Owner s Manual 06 12 15
KD-972 Owner's Manual-Rev2
OWNER’S MANUAL
1
iHealthTM
Wireless Blood Pressure Wrist Monitor (BP7)
OWNER’S MANUAL
Table of Contents
INTRODUCTION ......................................................................................................................... 2
PACKAGE CONTENTS .............................................................................................................. 2
INTENDED USE ........................................................................................................................... 2
BLOOD PRESSURE CLASSIFICATION FOR ADULTS ......................................................... 2
CONTRAINDICATION ............................................................................................................... 2
PARTS AND DISPLAY INDICATORS ...................................................................................... 3
SET UP REQUIREMENTS ......................................................................................................... 3
SET UP PROCEDURES............................................................................................................... 4
MEASUREMENT PROCEDURES ............................................................................................. 4
SPECIFICATIONS ....................................................................................................................... 6
GENERAL SAFETY AND PRECAUTIONS .............................................................................. 6
BATTERY HANDLING AND USAGE ....................................................................................... 9
TROUBLESHOOTING .............................................................................................................. 10
CARE AND MAINTENANCE ................................................................................................... 91
WARRANTY INFORMATION ............................................................................................... 102
EXPLANATION OF SYMBOLS ............................................................................................. 102
IMPORTANT INFORMATION REQUIRED BY THE FCC ................................................ 113
OTHER STANDARDS AND COMPLIANCES ...................................................................... 125
ELECTROMAGNETIC COMPATIBILITY INFORMATION ............................................ 125
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INTRODUCTION
Thank you for selecting the iHealth Wireless Blood Pressure Wrist Monitor. The iHealth Wireless
Blood Pressure Wrist Monitor is a fully automatic wrist cuff blood pressure monitor that uses the
oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your
iOS devices to test, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 iHealth Wireless Blood Pressure Wrist Monitor
• 1 Owner’s Manual
• 1 Quick Start Guide
• 1 Travel Bag
• 1 Charging Cable
INTENDED USE
The iHealth Wireless Blood Pressure Wrist Monitor (Electronic Sphygmomanometer) is intended
for use in a professional setting or at home and is a non-invasive blood pressure measurement
system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an
adult individual by using a technique in which an inflatable cuff is wrapped around the wrist. The
measurement range of the cuff circumference is 5.3” to 8.6’’ (13.5cm-22cm)
BLOOD PRESSURE CLASSIFICATION FOR ADULTS
The World Health Organization (WHO) has created the following guide for assessing high blood
pressure (without regard to age or gender). Please note that other factors (e.g. diabetes, obesity,
smoking, etc.) also need to be considered. Consult with your physician for accurate assessment.
Note: This chart is not intended to provide a basis for any type of emergency condition or diagnosis
based on the color scheme; this chart only depicts different classifications of blood pressure.
Consult your physician for proper interpretation of blood pressure results.
CONTRAINDICATION
It is not recommended for people with serious arrhythmia to use this Wireless Blood Pressure
Wrist Monitor.
3
PARTS AND DISPLAY INDICATORS
SET UP REQUIREMENTS
The iHealth Wireless Blood Pressure Wrist Monitor is designed to be used with the following iPod
touch, iPhone and iPad models:
iPod touch (4th generation)
iPod touch (3rd generation)
iPhone 4S
iPhone 4
iPhone 3GS
iPad (3rd generation)
iPad 2
iPad
The iOS version of these devices should be V4.0 or higher.
SET UP PROCEDURES
Download the FREE iHealth App
Prior to first use, download and install the iHealth App from the App Store. Use keyword
search terms “iHealth”, “BP7” or ”BPM”.
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Connect to iOS device via Bluetooth
Apply the cuff or press the START/STOP button until the
Bluetooth indicator light flashes.
Turn Bluetooth “On” under the “Settings” Menu
(Settings->General->Bluetooth->On)
When using the monitor for the first time, wait until the monitor
ID (printed on the monitor), i.e. "BP7 xxxxxx" and "Not Paired"
appear in the list of available Bluetooth devices on your iOS
device. Select the monitor ID “BP7 xxxxxx” to pair and connect.
Note: When pairing the monitor for the first time or after it has
been reset it may take up to 30 seconds for your iOS device to
detect the Bluetooth signal. Each subsequent time you use the
monitor "Not Connected" will be displayed next to “BP7 xxxxxx”
in the Bluetooth Menu. Pairing the monitor with your iOS device
at each use is required.
MEASUREMENT PROCEDURES
Apply the Cuff
a. Place your hand palm-side up in front of you and wrap the cuff
around a bare wrist 1-2 cm above the wrist joint
b. If the monitor is correctly placed, the iHealth logo will be facing
upright.
c. The cuff must not be too tight nor too loose.
Remember to:
1. Make sure that the appropriate cuff size is used; refer to the cuff
circumference range in “SPECIFICATIONS”.
2. Measure on the same wrist each time.
3. Stay still during measurement. Do not move your wrist, body, or
the monitor.
4. Stay still and calm for one to one and half minutes before taking a blood pressure
measurement.
5. Keep the cuff clean. Cleaning the cuff after every 200 times of usage is recommended.
If the cuff becomes dirty, clean it with a moistened cloth. Do not rinse the monitor or
cuff with running water.
Body Posture
Blood pressure wrist monitors are sensitive to body position. To get the most accurate reading
possible it is very important that you keep your arm and wrist at heart level.
Sitting During Measurement
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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 table.
c. The middle of the cuff should be at the level of the right atrium of your heart.
Note: Blood pressure can be affected by the position of the cuff and your
physiologic condition.
During measurement, press the “START/STOP” button for 2 seconds to turn off the monitor
manually.
Operation Instructions With iOS Device
Before measurement begins, adjust the height of your wrist until it is level with the right atrium of
your heart. The App will detect your wrist position and the measurement will begin automatically
when the correct position is detected,. If not positioned correctly, the measurement will not start.
Do not move and maintain a steady position until the measurement is completed.
During measurement, press the “START/STOP” button to stop measurement, Press the
START/STOP” button for 2 seconds to turn off the monitor manually.
For detailed operating instructions, please visit http://www.ihealthlabs.com.
Note: Please consult a healthcare professional for interpretation of blood pressure measurements.
Measuring without an iOS Device
Offline measurement is enabled automatically at your first online measurement. To start offline
measurement when disconnected from the iOS device, turn on the monitor by pressing the
START/STOP button. The status indicator light will be green and the monitor will begin
measurement. If measured successfully, the measurement will be stored in the iHealth Wireless
Blood Pressure Wrist Monitor and the status indicator light will flash green. The reading is not
visible until the next iOS connection. The measurement will be uploaded to the device
automatically upon the next iOS connection. Otherwise the status indicator will be red for a
moment then change to flashing green. The monitor will turn off automatically after 2 minutes of
non-operation. Alternatively, you can keep on pressing the “START/STOP” button for 2 seconds to
turn off the monitor manually.
During measurement, press the “START/STOP” button to stop the measurement process.
Important: Please consult a healthcare professional for interpretation of blood pressure
measurements
Monitor Status Bluetooth Indicator
Waiting to connect Flashing blue light
Measuring Steady blue light
Measurement completed Gradually extinguishing light
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SPECIFICATIONS
1. Product name: iHealth Wireless Blood Pressure Wrist Monitor
2. Model: BP7
3. Classification: Internally powered, Type BF applied part, IPX0, No AP or APG, Continuous
operation
4. Machine size: approx. 2.8” x 2.9” x 0.7” (72mm × 74mm × 17.6mm)
5. Cuff circumference: 5.3’’- 8.6’’(13.5cm-22cm)
6. Weight: approx. 3.7 oz (106g) (including cuff)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 120 times with time and date stamp (off-line measurement only)
9. Power: DC:5V 1.0A,
Battery: 1*3.7V Li-ion 400mAh
10. Measurement range:
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
11. Accuracy:
Pressure: ±3 mmHg
Pulse rate: ±5%
12. Wireless communication:
Bluetooth V3.0 + EDR Class 2 SPP
Frequency Band: 2.402-2.480 GHz
13. Environmental temperature for operation: 5℃～40℃(41℉～104℉)
14. Environmental humidity for operation: ≤90%RH
15. Environmental temperature for storage and transport: -20℃～55℃(-4℉～131℉)
16. Environmental humidity for storage and transport: ≤95%RH
17. Environmental pressure: 80kPa-105kPa
18. Battery life: more than 80 measurements on a full charge
19. The blood pressure measurement system includes accessories: pump, valve, cuff, and sensor.
Note: These specifications are subject to change without notice.
GENERAL SAFETY AND PRECAUTIONS
1. Read all of the information in the Owner’s Manual and other provided instructions before
operating the unit.
2. Consult your physician for any of the following situations:
a) The application of the cuff over a wound or inflamed area
b) The application of the cuff on any limb with intravascular access or therapy, or an
arterio-venous (A-V) shunt
c) The application of the cuff on the wrist on the side of a mastectomy
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d) Simultaneous use with other medical monitoring equipment on the same limb
e) The blood circulation of the user needs to be checked
3. This Wireless Blood Pressure Wrist Monitor is designed for adults and should never be used
on infants, young children, pregnant or pre-eclamptic patients. Consult your physician before
use on children.
4. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
5. Blood pressure measurements determined by this product are equivalent to those obtained by
professional healthcare practitioners using the cuff/stethoscope auscultation method within the
limits prescribed by the American National Standard, Electronic or Automated
Sphygmomanometer.
6. Information regarding potential electromagnetic or other interference between the blood
pressure monitor and other devices together with advice regarding avoidance of such
interference, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is
suggested that the blood pressure monitor be kept 10 meters away from other wireless devices,
such as WLAN unit, cell phone, microwave oven, etc.
7. It is recommended that the iOS device be set in Airplane mode during measurement to avoid
strong magnetism interference. If a call comes in during the measurement, the measurement
process will be terminated automatically.
8. If Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol
will be displayed. Under this condition, the Wireless Blood Pressure Wrist Monitor can keep
functioning, but the results may be inaccurate. Please consult your physician for accurate
assessment.
There are 2 conditions under which the signal of IHB will be displayed:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period ≥0.14s and the number of such pulse takes more than
53 percent of the total number of pulses.
9. Please do not use any other cuff other than that supplied by the manufacturer as this may result
in measurement errors and a biocompatible hazard.
10. This product might not meet its performance specifications if stored or used outside the
specified temperature and humidity ranges.
11. Please do not share the cuff with any infectious person to avoid cross-infection.
12. This product should not be used as a USB device.
13. This product is verified by auscultatory method. It is recommended that you check Annex B of
ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details if needed.
14. If the determined blood pressure (systolic or diastolic) is outside the rated range specified in
part SPECIFICATIONS, the app will immediately display a technical alarm on screen. In this
case, consult a physician or ensure that proper measurement procedures are followed. The
technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical
alarm is assigned as low priority according to IEC 60601-1-8.The technical alarm is
non-latching and does not need to be reset.
15. A medical AC adapter with an output of DC 5.0V and complies with IEC 60601-1/UL 60601-1
and IEC 60601-1-2/EN 60601-1-2 is suitable for this monitor, such as ASP5-05010002JU
(input: 100-240V, 50/60Hz, 200mA; output: DC 5V, 1.0A). Please note that the monitor jack
size is USB mini B.
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BATTERY HANDLING AND USAGE
Do not change the battery. If the battery can no longer be charged, please contact Customer
Service.
• When charging is needed, please connect the monitor to a power source. The monitor can
work normally while charging.
• When the monitor is connected to an iPod touch, iPhone, or iPad, the battery volume will be
displayed on the iPod touch, iPhone, or iPad screen. If the power is less than 25%, please
charge the battery. The monitor will not work until the battery has enough power.
• When you charge the monitor, the LED will display with different colors indicating the
charging status. See the table below for details.
• It is suggested that you charge the battery when the battery is less than 25%. Overcharging
the battery may reduce its lifetime.
Lithium battery replacement by inadequately trained personnel could result in a hazard
such as a fire or explosion.
Do not plug or unplug the power cord into the electrical outlet with wet hands.
If the AC adapter is abnormal, please change the adapter.
Do not pull out the adapter when you are using the monitor.
Do not use any other type of AC adapter as it may harm the monitor.
The monitor, cable, battery and cuff must be disposed of according to local regulations
at the end of their usage.
Note
：
The battery has limited charge cycles and may eventually need to replaced by an
iHealth service provider. Battery life and charge cycles vary by use and settings.
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
TROUBLESHOOTING
PROBLEM POSSIBLE CAUSE SOLUTION
Low Battery Battery is less than 20% Charge the battery
Display reads
“ERROR”
Blood pressure is outside
of measurement range
Retest, make sure your blood
pressure is within measurement
range
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Wrist or monitor was
moved during test
Retest, make sure not to move your
wrist or the monitor
The cuff does not inflate
properly or pressure falls
quickly during test
Review the cuff application
instructions and retest
Irregular heartbeat
(arrhythmia)
It is inappropriate for people with
serious arrhythmia to use this
monitor.
Check with physician.
The cuff was not
properly applied or the
rubber tube was bent or
pressed
Review the cuff application
instructions and retest
Display reads an
abnormal result
The cuff position was not
correct or it was not
properly tightened.
Review the cuff supplication
instructions and retest.
Body posture was not
correct during testing
Review body posture instructions
and retest
Speaking, moving wrist
or body, being angry,
excited or nervous during
test
Retest when calm; avoid speaking or
movement during the test
Bluetooth connection
unstable
Bluetooth connection
unsuccessful, BP7 is
abnormal, or strong
electromagnetic
interference is present
Reset iOS device. Reset BP7 by
pressing the START/STOP button
about 10s. Make sure the monitor
and iOS device are away from other
electrical equipment. Please see
GENERAL SAFETY AND
PRECAUTIONS.
No response Incorrect operation or
strong electromagnetic
interference
Press the START/STOP button
about 10 seconds to reset the device,
relaunch app, and reconnect the iOS
device to the monitor
CARE AND MAINTENANCE
1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and direct sunlight. Do not immerse the monitor in water as this
will result in damage to the monitor.
3. If this monitor is stored near freezing temperatures, allow it to acclimate to room temperature
before use.
4. Do not attempt to disassemble this monitor.
5. If the monitor is not used for a long time, please sure to fully charge it every month.
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6. It is recommended that product performance be checked every 2 years or after each repair.
Please contact the service center.
7. No monitor component needs to be maintained by the user. The circuit diagrams, component
part lists, descriptions, calibration instructions, or other information which will assist the user’s
appropriately qualified technical personnel to repair those parts of the equipment which are
designated for repair can be supplied.
8. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent
9. The monitor can maintain the safety and performance characteristics for a minimum of 10,000
measurements or three years of usage.
10. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
Battery replacement should only be performed by a qualified iHealth technician. To do
otherwise will void your warranty and possibly damage your unit.
11. Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise
will possibly damage your unit.
12. It is recommended that if the cuff is used, for example, in a hospital or a clinic, it be disinfected
twice a week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth
lightly moistened with Ethyl alcohol (75-90%). Then air dry the cuff.
WARRANTY INFORMATION
The iHealth Wireless Blood Pressure Wrist Monitor is warranted to be free from defects in
materials and workmanship within one year from the date of purchase when used in accordance
with the provided instructions. The warranty extends only to the end user. We will, at our option,
repair or replace without charge the iHealth Wireless Blood Pressure Wrist Monitor covered by the
warranty. Repair or replacement is our only responsibility and your only remedy under the
warranty.
EXPLANATION OF SYMBOLS
Symbol for ”THE OPERATION GUIDE MUST BE READ”
The sign background color: blue
The sign graphical symbol: white
Symbol for “WARNING”
Symbol for “TYPE BF APPLIED PARTS” (Cuff only)
Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be
disposed of with household waste. Please recycle where facilities exist. Check with your
local authority or retailer for recycling advice”.
Symbol for “MANUFACTURER”
Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”
11
EC REP
47 Spenlow House Bermondsey London SE16 4SJ
Symbol for “SERIAL NUMBER”
Symbol for “EUROPEAN REPRESENTATIVE”
Symbol for “KEEP DRY”
iHealth is a trademark of iHealth Lab Inc.
“Made for iPod”, “Made for iPhone”, and “Made for iPad” mean that an electronic accessory has
been designed to connect specifically to iPod, iPhone, or iPad, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the operation
of this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPod, iPhone, or iPad may affect wireless performance. iPad, iPhone, and iPod
touch are trademarks of Apple Inc., registered in the U.S. and other countries.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and
any use of such marks by iHealth Lab Inc. is under license. Other trademarks and trade names are
those of their respective owners.
Manufactured for iHealth Lab Inc.
719 N. Shoreline Blvd., Mountain View, CA 94043, USA
1-855-816-7705
www.ihealthlabs.com
Lotus Global Co., Ltd.
15 Alexandra Road, London UK, NW8 0DP
Tel: +0044-20-75868010 Fax: +0044-20-79006187
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China
Tel: 86-22-60526161
IMPORTANT INFORMATION REQUIRED BY THE FCC
This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by iHealth Lab Inc. would void the user’s
authority to operate the product.
NOTE: This product has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This product generates, uses,
and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this product does cause
EC REP
47 Spenlow House Bermondsey London SE16 4SJ
12
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/TV technician for help.
This product complies with Industry Canada. IC: RSS-210
This product is approved in accordance to R&TTE directive transmitter.
IC NOTICE
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is
subject
to the following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of the
device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne
doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d'en compromettre le
fonctionnement.
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Wrist Monitor corresponds to the following standards: IEC
60601-1:2006 (Medical electrical equipment – Part 1: General requirements for safety), 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, ANSI/AAMI/IEC 80601-2-30:2009 (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 Wrist 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 Wrist 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
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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 Wrist Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the Wireless Blood Pressure Wrist Monitor should assure
that it is used in such an environment.
IMMUNITY
test IEC 60601test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 2 kV for power
supply lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions
and
voltage
variations
on power
supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the monitor
requires continued operation during
power mains interruptions, it is
recommended that the monitor be
powered from an uninterruptible
power supply or a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 3
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
14
Guidance and manufacturer’s declaration - electromagnetic immunity
The Wireless Blood Pressure Wrist Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the Wireless Blood Pressure Wrist Monitor should
assure that it is used in such an environment.
IMMUNITY
test
IEC 60601test
level
Compliance
level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms 150 kHz
to 80 MHz
3 V/m 80 MHz
to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the monitor, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance：
：：
：
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the monitor is used exceeds the applicable RF compliance level
Pd 2.1=
Pd 2.1=
Pd 3.2=
15
above, the monitor should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the monitor.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 4
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the Wireless Blood Pressure Wrist
Monitor
The Wireless Blood Pressure Wrist Monitor is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the Wireless Blood
Pressure Wrist Monitor can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the monitor
as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Pd 2.1=Pd 2.1=Pd 3.2=