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Wireless Blood Pressure Wrist Monitor (BP7)
OWNER'S MANUAL
Table of Contents
EN
INTRODUCTION
PACKAGE CONTENTS
INTENDED USE
BLOOD PRESSURE CLASSIFICATION FOR ADULTS
CONTRAINDICATION
PARTS AND DISPLAY INDICATORS
SET UP REQUIREMENTS
SET UP PROCEDURES
MEASUREMENT PROCEDURES
SPECIFICATIONS
GENERAL SAFETY AND PRECAUTIONS
BATTERY HANDLING AND USAGE
TROUBLESHOOTING
CARE AND MAINTENANCE
WARRANTY INFORMATION
EXPLANATION OF SYMBOLS
IMPORTANT INFORMATION REQUIRED BY THE FCC
OTHER STANDARDS AND COMPLIANCES
ELECTROMAGNETIC COMPATIBILITY INFORMATION
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iHealth
TM
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 mobile devices to test, track and share vital blood pressure data.
PACKAGE CONTENTS
• 1 Wireless Blood Pressure Wrist Monitor
• 1 Owner’s Manual
• 1 Quick Start Guide
• 1 Charging Cable
• 1 Travel Case
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 8.7"
(13.5cm-22cm).
1
!
160
180
Systolic
(mmHg)
Diastolic
(mmHg)
140
130
120
80 85 90 100 110
Severe Hypertension
Moderate Hypertension
Mild Hypertension
High-normal BP
Normal BP
Classification of blood pressure for adults
BLOOD PRESSURE
CLASSIFICATION
SBP
mmHg
DBP
mmHg
COLOR
INDICATOR
Optimal <120 <80 GREEN
Normal
120-129 80-84
GREEN
High-normal
130-139 85-89
Grade 1 Hypertension
140-159 90-99
GREEN
Grade 2 Hypertension
160-179 100-109
YELLOW
Grade 3 Hypertension RED
ORANGE
≥180 ≥100
WHO/ISH Denitions and Classication of Blood Pressure Levels
BLOOD PRESSURE CLASSIFICATION FOR ADULTS
The World Health Organization (WHO) has created the following guide for assessing high blood
pressur e (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.
2
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 (5th generation)
iPod touch (4th generation)
iPod touch (3rd generation)
iPhone 5
iPhone 4S
iPhone 4
iPhone 3GS
iPad (4th generation)
iPad (3rd generation)
iPad 2
iPad
iPad mini
The iOS version of these devices should be V5.0 or higher.
Cuff
Status indicator
Bluetooth indicator
Adapter Jack
START/STOP
START/STOP button
3
Connect to iOS Device via Bluetooth
a. Apply the cuff or press the START/STOP button,
the Bluetooth indicator will begin flashing.
b. Turn Bluetooth "On" under the "Settings" Menu on
the iOS device.
c. Wait until the model name printed on the monitor,
(i.e."BP7 xxxxxx") and "Not Paired"appear in the
Bluetooth menu, and select the model name "BP7
xxxxxx" to pair and connect. The Bluetooth
indicator will remain steady upon successful
connection. When using the monitor for the first
time, it may take up to 30 seconds for your iOS
device to detect the Bluetooth signal.
SET UP PROCEDURES
Download the Free iHealth App
Prior to first use, download and install "iHealth MyVitals" from the App Store.
Account Set Up and Registration
Follow the on-screen instructions to register and set up your personal account.
Charge Battery Prior First Time Use
Connect the monitor to a USB port using the charging cable provided until the green indicator
light stabilizes.
d. Each subsequent time you use the monitor, "Not Connected" will be displayed next to"BP7
xxxxxx" in the Bluetooth Menu.
e. Please repeat these steps when you switch to another iOS device with the monitor.
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MEASUREMENT PROCEDURES
Blood pressure can be affected by the position of the cuff and your physiologic
condition. It is very important that you keep your wrist at heart level.
Waiting to connect Flashing blue light
Connected and measuring Steady blue light
Measurement completed and ready to disconnect
Gradually extinguishing light
Monitor Status
Bluetooth Indicator
1. Be seated comfortably with your feet flat on the floor without crossing your
legs. Stay still during measurement. Do not move your wrist, body, or the
monitor.
2. Place your hand palm-side up in front of you and wrap the cuff around a bare
wrist 1/2" (1-2cm) above the wrist joint. If the monitor is correctly placed,
iHealth logo will be facing upright.
3. The middle of the cuff should be at the level of the right atrium of your heart.
4. It is advised to place the monitor’s travel case under your arm for support and
to keep your arm at optimal height for measurement.
5. Adjust the height of your wrist, the App will detect your wrist position and the
measurement will start ONLY when the correct position is detected. Follow the
on-screen instructions to begin measurement.
iHealth
1/2" (1-2cm)
iHealth
START
5
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 and calm for one to one and half minutes before taking a
blood pressure measurement. Prolonged over-inflation of the bladder
may cause ecchymoma of your arm.
4. 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.
Press the "START/STOP" button to stop measurement. Press the "START/STOP" button for 2
seconds to turn off the monitor manually.
Auto Connect Option
Auto connect option allows the monitor to find the last used iOS device and reestablish the
connection with your iOS device automatically. Auto connect option can be enabled in the App.
(Device Setting->Auto Connect->On).
Taking Measurements with Multiple iOS Devices
Turn off the Bluetooth on the last used iOS device if the Auto Connect option isenabled in your
App, then follow the set up instructions in the Quick Start Guide.
Measuring without an iOS Device
Enable the Offline Measurement function on the App. (Device Setting->Offline Measurement->On)
Apply the cuff, follow the measurement instructions, and then press the "START/STOP" button to
begin measurement. All offline measurements will be uploaded to the App automatically upon the
next successful Bluetooth connection.
For detailed operating instructions, please visit www.ihealthlabs.com.
Note: Physical activity including eating, drinking, and smoking as well as excitement, stress, and
many other factors influence blood pressure results.
ATTENTION: You can stop the measurement process at any time by pressing and holding the
"START/STOP" button for 2 seconds.
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SPECIFICATIONS
1. Product name: 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"×2.9"×0.7" (72mm×74mm×17.6mm)
5. Cuff circumference: 5.3"- 8.7" (13.5cm-22cm), one size only
6. Weight: approx. 3.7oz(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:5.0V 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°C~40°C(41°F~104°F)
14. Environmental humidity for operation: ≤90%RH
15. Environmental temperature for storage and transport:-20°C~55°C(-4°F~131°F)
16. Environmental humidity for storage and transport: ≤90%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.
Auto Connect Option
Auto connect option allows the monitor to find the last used iOS device and reestablish the
connection with your iOS device automatically. Auto connect option can be enabled in the App.
(Device Setting->Auto Connect->On).
Taking Measurements with Multiple iOS Devices
Turn off the Bluetooth on the last used iOS device if the Auto Connect option isenabled in your
App, then follow the set up instructions in the Quick Start Guide.
Measuring without an iOS Device
Enable the Offline Measurement function on the App. (Device Setting->Offline Measurement->On)
Apply the cuff, follow the measurement instructions, and then press the "START/STOP" button to
begin measurement. All offline measurements will be uploaded to the App automatically upon the
next successful Bluetooth connection.
For detailed operating instructions, please visit www.ihealthlabs.com.
Note: Physical activity including eating, drinking, and smoking as well as excitement, stress, and
many other factors influence blood pressure results.
ATTENTION: You can stop the measurement process at any time by pressing and holding the
"START/STOP" button for 2 seconds.
7
SPECIFICATIONS
1. Product name: 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"×2.9"×0.7" (72mm×74mm×17.6mm)
5. Cuff circumference: 5.3"- 8.7" (13.5cm-22cm), one size only
6. Weight: approx. 3.7oz(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:5.0V 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°C~40°C(41°F~104°F)
14. Environmental humidity for operation: ≤90%RH
15. Environmental temperature for storage and transport:-20°C~55°C(-4°F~131°F)
16. Environmental humidity for storage and transport: ≤90%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.
d) Simultaneous use with other medical monitoring equipment on the same limb.
e) The blood circulation of the user needs to be checked.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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 Sphygmomanom-
eter.
5. When a call comes in during the measurement, the measurement process will be terminated
automatically. It is recommended that the iOS device be set in Airplane mode during measure-
ment to avoid strong magnetism interference.
6. 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.
7. 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.
8. Information regarding potential electromagnetic or other interference between the blood
pressure monitor and other devices together with advice regarding avoidance of such interfer-
ence, 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, microwave oven, etc.
9. This product should not be used as a USB device.
10. 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.
11. 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.
12. 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 5.0V, 1.0A). Please note that the monitor jack
size is USB mini B.
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.
This product might not meet its performance specifications if stored or used outside the
specified temperature and humidity ranges.
Please do not share the cuff with any infectious person to avoid cross-infection.
8
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.
d) Simultaneous use with other medical monitoring equipment on the same limb.
e) The blood circulation of the user needs to be checked.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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 Sphygmomanom-
eter.
5. When a call comes in during the measurement, the measurement process will be terminated
automatically. It is recommended that the iOS device be set in Airplane mode during measure-
ment to avoid strong magnetism interference.
6. 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.
7. 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.
8. Information regarding potential electromagnetic or other interference between the blood
pressure monitor and other devices together with advice regarding avoidance of such interfer-
ence, 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, microwave oven, etc.
9. This product should not be used as a USB device.
10. 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.
11. 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.
12. 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 5.0V, 1.0A). Please note that the monitor jack
size is USB mini B.
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.
This product might not meet its performance specifications if stored or used outside the
specified temperature and humidity ranges.
Please do not share the cuff with any infectious person to avoid cross-infection.
9
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!
!
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.
d) Simultaneous use with other medical monitoring equipment on the same limb.
e) The blood circulation of the user needs to be checked.
3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.
4. 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 Sphygmomanom-
eter.
5. When a call comes in during the measurement, the measurement process will be terminated
automatically. It is recommended that the iOS device be set in Airplane mode during measure-
ment to avoid strong magnetism interference.
6. 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.
7. 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.
8. Information regarding potential electromagnetic or other interference between the blood
pressure monitor and other devices together with advice regarding avoidance of such interfer-
ence, 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, microwave oven, etc.
9. This product should not be used as a USB device.
10. 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.
11. 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.
12. 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 5.0V, 1.0A). Please note that the monitor jack
size is USB mini B.
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.
This product might not meet its performance specifications if stored or used outside the
specified temperature and humidity ranges.
Please do not share the cuff with any infectious person to avoid cross-infection.
BATTERY HANDLING AND USAGE
• When the monitor is connected to an iOS device, the battery volume will be displayed on the iOS
device. 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.
• When charging is needed, please connect the monitor to a power source. The monitor can work
normally while charging.
• It is suggested that you charge the battery when the battery is less than 25%. Overcharging the
battery may reduce its lifetime.
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Charging Flashing green light
Fully charged Steady green light
Low battery Flashing red light (for a few seconds)
Abnormal state Steady red light
Monitor Status
Status Indicator
!
!
!
!
!
!
!
BATTERY HANDLING AND USAGE
• When the monitor is connected to an iOS device, the battery volume will be displayed on the iOS
device. 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.
• When charging is needed, please connect the monitor to a power source. The monitor can work
normally while charging.
• It is suggested that you charge the battery when the battery is less than 25%. Overcharging the
battery may reduce its lifetime.
Do not change the battery. If the battery can no longer be charged, please contact Customer
Service.
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.
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Note: Battery life and charge cycles vary by use and settings.
PROBLEMA POSSIBILE CAUSA SOLUZIONE
Battery is less than 25% Charge the batteryLow Battery
Blood pressure is outside of measurement range Retest, make sure your blood pressure is within
measurement range
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
The cuff position was not correct or it was not
properly tightened.
Review the cuff application instructions and retest.
Review body posture instructions and retest
Retest when calm; avoid speaking or movement during
the test
Body posture was not correct during testing
Speaking, moving wrist or body, being angry,
excited or nervous during test
Review the cuff application instructions and retest
Display reads
“ERROR”
Display reads
an abnormal
result
Bluetooth
connection
unstable
Bluetooth connection unsuccessful, monitor is
abnormal, or strong electromagnetic interference
is present
Reset iOS device. Reset monitor 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.
Incorrect operation or strong electromagnetic
interference
Retest, make sure not to move your wrist or the monitor
No response
TROUBLESHOOTING
12
!
!
!
!
CARE AND MAINTENANCE
1. If this monitor is stored near freezing temperatures, allow it to acclimate to room temperature
before use.
2. If the monitor is not used for a long time, please sure to fully charge it every month.
3. It is recommended that product performance be checked every 2 years or after each repair.
Please contact the service center.
4. 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.
5. Clean the monitor with a dry, soft cloth or a moistened and well wrung soft cloth using water,
diluted disinfectant alcohol, or diluted detergent.
6. The monitor can maintain the safety and performance characteristics for a minimum of 10,000
measurements or three years of usage, and the cuff integrity is maintained after 1,000 open-close
cycles of the closure.
7. The battery can maintain the performance characteristics for a minimum of 300 charge cycles.
8. 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.
Do not drop this monitor or subject it to strong impact.
Avoid high temperature and direct sunlight. Do not immerse the monitor in water
as this will result in damage to the monitor.
Do not attempt to disassemble this monitor.
Battery replacement should only be performed by a qualified iHealth technician.
To do otherwise will void your warranty and possibly damage your unit.
Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise
will possibly damage your Unit.
13
Symbol for "KEEP DRY"
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 "THE OPERATION GUIDE MUST BE READ"
The sign background color:blue The sign graphical symbol:white
Symbol for "TYPE BF APPLIED PARTS" (Cuff only)
!
Do not drop this monitor or subject it to strong impact.
Avoid high temperature and direct sunlight. Do not immerse the monitor in water
as this will result in damage to the monitor.
Do not attempt to disassemble this monitor.
Battery replacement should only be performed by a qualified iHealth technician.
To do otherwise will void your warranty and possibly damage your unit.
Cuff replacement should only be performed by a qualified iHealth technician. To do otherwise
will possibly damage your Unit.
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
14
Symbol for "WARNING"
!
Symbol for "EUROPEAN REPRESENTATIVE"
EC REP
Symbol for "COMPILES WITH MDD93
/42/EEC REQUIREMENTS"
Symbol for
"
MANUFACTURER
"
Symbol for "SERIAL NUMBER"
SN
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.
15
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
16
Manufactured for iHealth Lab Inc.
719 N. Shoreline Blvd., Mountain View, CA 94043, USA
+1-855-816-7705 www.ihealthlabs.com
EC REP
Lotus Global Co., Ltd.
15 Alexandra Road, London UK, NW8 0DP
Tel: +0044-20-75868010 Fax: +0044-20-79006187
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Wrist Monitor corresponds to the following standards:
IEC 60601-1:2005 (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: Supplemen-
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
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.
This product is approved in accordance to R&TTE directive transmitter.
tary 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).
17
For all ME EQUIPMENT and ME SYSTEMS
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions IEC
61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
Complies
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
nearby electronic equipment.
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.
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.
Guidance and manufacture’s declaration - electromagnetic emissions
Table 1
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Wrist Monitor corresponds to the following standards:
IEC 60601-1:2005 (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: Supplemen-
ELECTROMAGNETIC COMPATIBILITY INFORMATION
tary 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).
18
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 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 % U
T(>95 % dip in UT)
for 0,5 cycle
40 % U
T(60 % dip in UT)
for 5 cycle
70 % U
T(30 % dip in UT)
for 25 cycle
<5 % U
T(>95 % dip in UT)
for 5 s
<5 % UT(>95 % dip in UT)
for 0,5 cycle
40 % U
T(60 % dip in UT)
for 5 cycle
70 % U
T(30 % dip in UT)
for 25 cycle
<5 % U
T(>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/m3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
IEC 60601test level Compliance level
For all ME EQUIPMENT and ME SYSTEMS
Table 2
Guidance and manufacturer’s declaration - electromagnetic immunity
Note: UT is the a.c. mains voltage prior to application of the test level.
19
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.
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
IMMUNITY test
IEC 60601test level
Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms 150 kHz to
80 MHz
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:
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz to
2.5 GHz
Pd 2.1=
Pd 2.1=
80 MHz to 800 MHz
Pd 3.2=
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:
Table 3
20
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 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.
21
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Pd 2.1= Pd 2.1= Pd 3.2=
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
0.12 0.230.120.01
0.38 0.730.380.1
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.
1.2 2.31.21
3.8 7.33.810
12 2312100
Table 4
22
OWNER’S MANUAL
MANUEL DE L'UTILISATEUR
MANUALE D’ISTRUZIONI
MANUAL DEL PROPIETARIO
BEDIENUNGSANLEITUNG
Wireless Blood Pressure Wrist Monitor
Tensiomètre de poignet sans fil
Misuratore di pressione wireless da polso
Monitor inalámbrico de presión arterial para la muñeca
Drahtloses Handgelenk-Blutdruckmessgerät
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