Andon Health 721 Blood Pressure Monitor User Manual

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DN:ZRY721-SMSY01 V1.0
Operation Guide
History Revision
NO
Revision
date
01
2015/08/13
Revision
Description
Originated
Version
V1.0
Drafter
李甲一
Approver
张飞
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DN:ZRY721-SMSY01 V1.0
Operation Guide
Operation Guide
(V1.0)
Product/project name：Blood Pressure Monitor
Model
name ：
Project
number：
Drafted
BC 57 (KD-721)
by:
Date
Reviewed by:
Date
Approved by:
Date
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DN:ZRY721-SMSY01 V1.0
Operation Guide
MODEL BC 57 (KD-721)
Fully Automatic Wrist Cuff Blood Pressure Monitor
(ELECTRONIC SPHYGMOMANOMETER)
OPERATION GUIDE
__________________________________________________________________________
INDEX
IMPORTANT INFORMATION ......................................................................... 2
CONTENTS AND DISPLAY INDICATORS ..................................................... 2
INTENDED USE .............................................................................................. 3
CONTRAINDICATION ..................................................................................... 3
PRODUCT DESCRIPTION .............................................................................. 3
SPECIFICATIONS ........................................................................................... 4
NOTICE ........................................................................................................... 4
SETUP AND OPERATING PROCEDURES .................................................... 7
1. BATTERY LOADING .................................................................................. 7
2. CLOCK AND DATE ADJUSTMENT ........................................................... 7
3. CONNECTING THE CUFF TO THE MONITOR .......................................... 9
4. APPLYING THE CUFF ................................................................................ 9
5. BODY POSTURE DURING MEASUREMENT .......................................... 10
6. TAKING YOUR BLOOD PRESSURE READING ...................................... 10
7. DISPLAYING STORED RESULTS ........................................................... 11
8. DELETING MEASUREMENTS FROM THE MEMORY ............................. 12
9. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS ......................... 12
10. TECHNICAL ALARM DESCRIPTION ..................................................... 12
11. TROUBLESHOOTING (1) ....................................................................... 13
12. TROUBLESHOOTING (2) ....................................................................... 13
MAINTENANCE ............................................................................................ 14
EXPLANATION OF SYMBOLS ON UNIT ..................................................... 14
WARRANTY INFORMATION ........................................................................ 15
SERVICE CENTER ....................................................................................... 15
ELECTROMAGNETIC COMPATIBILITY INFORMATION ............................ 15
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IMPORTANT INFORMATION
NORMAL BLOOD PRESSURE FLUCTUATION
All physical activity, excitement, stress, eating, drinking, smoking, body posture and many
other activities or factors (including taking a blood pressure measurement) will influence blood
pressure value. Because of this, it is mostly unusual to obtain identical multiple blood pressure
readings.
Blood pressure fluctuates continually ----- day and night. The highest value usually appears in
the daytime and lowest one usually at midnight. Typically, the value begins to increase at
around 3:00AM, and reaches to highest level in the daytime while most people are awake and
active.
Considering the above information, it is recommended that you measure your blood pressure
at approximately the same time each day.
Too frequent measurements may cause injury due to blood flow interference, please always
relax a minimum of 1 to 1.5 minutes between measurements to allow the blood circulation in
your arm to recover. It is rare that you obtain identical blood pressure readings each time.
CONTENTS AND DISPLAY INDICATORS
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INTENDED USE
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at
home and is a non-invasive blood pressure measurement system intended to measure the
diastolic and systolic blood pressures and pulse rate of an adult individual by using a
non-invasive technique in which an inflatable cuff is wrapped around the wrist.
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this Electronic
Sphygmomanometer.
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor, blood pressure
and pulse rate can be measured automatically and non-invasively. The LCD display will show
blood pressure and pulse rate. The most recent 2×60 measurements can be stored in the
memory with date and time stamp. The voice function will ease the operation. The Electronic
Sphygmomanometers corresponds to the below standards: IEC 60601-1:2005
corr.1(2006)+corr.2(2007)/EN 60601-1：2006/A11: 2011 (Medical electrical equipment -- Part
1: General requirements for basic safety and essential performance), IEC60601-1-2:2007/EN
60601-1-2:2007 /AC:2010 (Medical electrical equipment -- Part 1-2: General requirements for
basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests), IEC 80601-2-30：2009+Cor.2010(Medical electrical equipment
–Part 2-30: Particular requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers)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).
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Operation Guide
SPECIFICATIONS
1. Product name: Blood Pressure Monitor
2. Model: BC 57 (KD-721)
3. Classification: Internally powered, Type BF applied part,IPX0,No AP or APG,Continuous
operation
4. Machine size: Approx. 78mm×60mm×28mm
5. Cuff circumference: 14cm ~ 19.5cm(5 1/2″~ 7 11/16″)
6. Weight: Approx. 67g (2 3/8oz.) (exclude batteries)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 2×60 times with time and date stamp
9. Power source: batteries: 2 ×1.5V
10. Measurement range:
SIZE AAA
Cuff pressure: 0-300mmHg
Systolic:
60-260mmHg
Diastolic:
40-199mmHg
Pulse rate:
40-180 beats/minute
11. Accuracy:
Pressure:
±3mmHg
Pulse rate:
±5%
12. Environmental temperature for operation: 10℃～40℃(50℉～104℉)
13. Environmental humidity for operation:
≤85%RH
14. Environmental temperature for storage and transport: -20℃～50℃(-4℉～122℉)
15. Environmental humidity for storage and transport: ≤85%RH
16. Environmental pressure: 80kPa-105kPa
17. Battery life: Approx 170 times.
18. All components belonging to the pressure measuring system, including accessories:
Pump,Valve, LCD, Cuff, Sensor
Note: These specifications are subject to change without notice.
NOTICE
1. Read all of the information in the operation guide and any other literature in the box before
operating the unit.
2. Stay still, calm and rest for 5 minutes before blood pressure measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measuring on same arm for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements to allow the blood
circulation in your arm to recover. Prolonged over-inflation (cuff pressure exceed 300
mmHg or maintained above15 mmHg for longer than 3 minutes) of the bladder may cause
ecchymoma of your wrist.
7. Consult your physician if you have any doubt about below cases:
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Operation Guide
1) The application of the cuff over a wound or inflammation diseases;
2) The application of the cuff on any limb where intravascular access or therapy, or an
arterio-venous (A-V) shunt, is present;
3) The application of the cuff on the wrist on the side of a mastectomy;
4) Simultaneously used with other monitoring medical equipments on the same limb;
5) Need to check the blood circulation of the user.
8.
This Electronic Sphygmomanometers is designed for adults and should never be
used on infants or young children. Consult your physician or other health care
professionals before use on older children.
9. Do not use this unit in a moving vehicle, This may result in erroneous measurement.
10. Blood pressure measurements determined by this monitor are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultation method, within the
limits prescribed by the American National Standard Institute, Electronic or automated
sphygmomanometers.
11. 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 part ELECTROMAGNETIC COMPATIBILITY INFORMATION.
12. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in the procedure
will be displayed. Under this condition,
of blood pressure measurement, a signal of
the Electronic Sphygmomanometers can keep function, but the results may not be
accurate, it’s suggested that you consult with 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 percentage of the total number of pulse.
13. Please do not use the cuff other than supplied by the manufacturer, otherwise it may bring
biocompatible hazard and might result in measurement error.
Please do not share the cuff with other infective person to avoid cross-infection.
14.
15. This equipment 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
equipment 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 equipment does cause 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.
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Operation Guide
16. 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.
17.Attention that changes or modification not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
18.Cet appareil est conforme à la section 15 des réglementations de la FCC. Le
fonctionnement de l’appareil est sujetaux deux conditions suivantes :
(1) cet appareil ne doit pas provoquer d’interférences néfastes, et
(2) cet appareil doit tolérer les interférences reçues, y compris celles qui risquent de
provoquer un fonctionnement indésirable.
19.Under Industry Canada regulations, this radio transmitter may only operate using an
antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry
Canada. To reduce potential radio interference to other users, the antenna type and its gain
should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than
that necessary for successful communication.
20.Measurements are not possible in patients with a high frequency of arrhythmias.
21.The device is not intended for use on neonates, children or pregnant women. (Clinical
testing has not been conducted on neonates, children or pregnant women.)
22.Motion, trembling, shivering may affect the measurement reading.
23.The device would not apply to the patients with poor peripheral circulation, noticeably low
blood pressure, or low body temperature (there will be low blood flow to the measurement
position).
24.The device would not apply to the patients who use an artificial heart and lung (there will be
no pulse)
25.Consult your physician before using the device for any of the following conditions: common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis,
poor perfusion, diabetes, pre-eclampsia, enal diseases.
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Operation Guide
SETUP AND OPERATING PROCEDURES
1. BATTERY LOADING
a. Open battery cover at the back of the monitor.
b. Load two “AAA” size batteries. Please pay attention to polarity.
c.
Close the battery cover.
When LCD shows battery symbol
, replace all batteries with new ones.
Rechargeable batteries are not suitable for this monitor.
Remove the batteries if the monitor will not be used for a month or more to avoid relevant
damage of battery leakage.
Avoid the battery fluid to get in your eyes. If it should get in your eyes, immediately
rinse with plenty of clean water and contact a physician.
The monitor, the batteries and the cuff, must be disposed of according to local
regulations at the end of their usage.
2. CLOCK AND DATE ADJUSTMENT
a. At first the Blood Pressure Monitor is totally off, once you insert the battery, the
Blood Pressure Monitor will enter Clock and Date Adjustment Mode.
b. If the time of the device is already set and need to be changed, adjustment can be
reached by pressing the “START/STOP” button for 5 seconds in Standby Mode.
c.
In Clock and Date Adjustment Mode , the time format will blink at first , see
picture2-1 .If the monitor has no result stored in the current user ,the default time
format is 24h(Europe Version) and the default clock and date is 2015-1-1 1:00,
else the default time format, clock and date is same as the most recent result’s.
d. Press the button “START/STOP” repeatedly, the year (first usage: default is 2015,
range is 2015~2099), month, day, hour and minute will blink in turn, see picture 22& 2-3 & 2-4 & 2-5 & 2-6. While the number is blinking, press the button “MEM” to
increase the number, keep on pressing the button "MEM", the number will
increase faster.
Picture 2-1
Picture 2-2
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Picture 2-3
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Picture 2-4
Operation Guide
Picture 2-5
Picture 2-6
e. After adjusted clock and date,the LCD will blink “bt” see picture 2-7.Press M2 will
alter START/STOP of bluetooth.If bluetooth is ON,a sign of
will flash.
Picture 2-7
f.
During adjusting clock and date, the monitor will go back to Standby Mode
automatically when no button will be pressed within 30 seconds.
g. You can turn off the monitor by pressing “START/STOP” button when the minute
is blinking, then the time and date is confirmed.
Note:
2.1 The clock format could be set by user.
2.2 Position of month and day depends on 12h or 24h time setting: 24h, day/month
(See Picture 2-8); 12h, month/day (See Picture 2-9).
Picture 2-8
Picture 2-9
2.3 All of the LCD illustrations are 24 hour format in the Operation Guide, except for
the picture 2-8.
2.4 Table 1 instructs the conversion relations between 24 hour format and 12 hour
format.
Table 1
24 hour format
12 hour format
24 hour format
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12 hour format
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Operation Guide
0:00
12:00 AM
12:00
12:00 PM
1:00
1:00 AM
13:00
1:00 PM
2:00
2:00 AM
14:00
2:00 PM
3:00
3:00 AM
15:00
3:00 PM
4:00
4:00 AM
16:00
4:00 PM
5:00
5:00 AM
17:00
5:00 PM
6:00
6:00 AM
18:00
6:00 PM
7:00
7:00 AM
19:00
7:00 PM
8:00
8:00 AM
20:00
8:00 PM
9:00
9:00 AM
21:00
9:00 PM
10:00
10:00 AM
22:00
10:00 PM
11:00
11:00 AM
23:00
11:00 PM
3. CONNECTING THE CUFF TO THE MONITOR
The cuff is attached to the monitor when it is packaged. Should the cuff become
unattached, align the two plugs and four brackets of the cuff with the plug sockets and
bracket sockets of the monitor and press the cuff to the monitor until the plugs and
brackets are securely attached.
4. APPLYING THE CUFF
a.
Place the cuff around a bare wrist 1-2cm above the wrist joint on the palm
side of the wrist.
b.
While seated, place the arm with the cuffed wrist in front of your body on a
desk or table with the palm up. If the cuff is correctly placed, you can read
the LCD display.
c.
The cuff must be neither too tight nor too loose.
Note:
•
Please refer to the cuff circumference range in “SPECIFICATIONS”
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Operation Guide
to make sure that the appropriate cuff is used.
•
Measuring on same wrist each time.
•
Do not move your arm, body, or the monitor during measurement.
•
Stay still, calm for 5 minutes before blood pressure measurement.
•
Please keep the cuff clean. Clean the cuff by wet soft cloth and mild detergent if
the cuff becomes dirty. Do not remove the cuff from the monitor.Clean the cuff
after the usage of every 200 times is recommended.
5. BODY POSTURE DURING MEASUREMENT
Sitting Comfortably Measurement
a. Be seated with your feet flat on the floor, and don’t cross your legs.
b. Place palm upside in front of you on a flat surface such as a desk or
table, with your elbow resting on a chair or table
c.
The middle of the cuff should be at the level of the right atrium of the heart.
6. TAKING YOUR BLOOD PRESSURE READING
a. After applying the cuff and your body is in a comfortable position,
press the “START/STOP” button. A beep is heard and all display
characters are shown for self-test. You can check the LCD display
according to the right picture. Please contact the service center if
segment is missing.
b. If the monitor has stored results, the LCD will momentarily display
the most recent one. If no result has been stored, zero will appear
on LCD.
c.
Then the monitor inflates the cuff until sufficient pressure has built up for a
measurement. Then the monitor slowly releases air from the cuff and carries out
the measurement. Finally the blood pressure and pulse rate will be
calculated and displayed on the LCD screen. The blood pressure
classification indicator and Irregular heartbeat symbol (if any) will
blink on the screen. The result will be automatically stored in the
monitor.
d. After measurement, the monitor will turn off automatically after 1 minute of no
operation.
e. If the bluetooth function is enabled, you can press “START/STOP” button to enter
the Bluetooth Transmittion Mode.Then press
“START/STOP”
button to
shutdown.If the bluetooth function is disabled, pressing “START/STOP” button will
turn it off directly.
f.
During measurement, you can press the “START/STOP” button to turn off the
monitor manually.
Note: Please consult a health care professional for interpretation of pressure measurements.
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Operation Guide
7. DISPLAYING STORED RESULTS
a. In StandBy Mode, press “MEM” button, the monitor will blink sign of current
group.Press “MEM” button to switch group,press “START/STOP” to confirm current
group.Then the amount of results in current user memory zone will be displayed. See
picture 8. Then LCD will display the average value of all results in the current user
memory zone.If the bluetooth function is on, the device will wait for pairing for 30s.
See picture 8-1. If no result stored in the current user memory zone, LCD will display
“0” for blood pressure and pulse rate. See picture 8-2.
b. Press “MEM” button, LCD will display the average value of all the results which is
measured from 5 o’clock to 9 o’clock in last 7 days in the current user memory zone.
See picture 8-3. If no result stored from 5 o’clock to 9 o’clock in last 7 days, LCD will
display “0” for blood pressure and pulse rate. See picture 8-4.
Picture 8
Picture 8-1
Picture 8-2
Picture 8-3
Picture 8-4
c. Press “MEM” button again, LCD will display the average value of all the results which
is measured from 18 o’clock to 20 o’clock in last 7 days in the current user memory
zone. See picture 8-5. If no result stored from 18 o’clock to 20 o’clock in last 7 days,
LCD will display “0” for blood pressure and pulse rate. See picture 8-6.
Picture 8-5
Picture 8-6
Picture 8-7
Picture 8-8
Picture 8-9
d. Press “MEM” button again, the most recent result will be displayed with date and time
stamp. See picture 8-7. Irregular heartbeat symbol (if any) and blood pressure
classification indicator will blink at the same time. If the monitor has no result stored in
the current user memory zone, the LCD will display “0” for blood pressure and pulse
rate. See picture 8-8.
e. Press “MEM” button again to review the next result. See picture 8-9. In this way,
repeatedly pressing the “MEM” button displays the respective results measured
previously.
f. When reviewing the results, the monitor will turn off automatically after 1 minute of no
operation. You can also press the “START/STOP” button to turn off the monitor
manually.
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Note:
Operation Guide
When the monitor displaying the measurement, the classification color indicator
can be shown different color according to the systolic pressure and diastolic
pressure. Refer to the “ASSESSING HIGH BLOOD PRESSURE FOR ADULTS”
section
8. DELETING MEASUREMENTS FROM THE MEMORY
When any average value is displaying, keeping on pressing button
“MEM” for three seconds, all results will be deleted after three “beep”.
When any result is displaying, keeping on pressing button “MEM” for
three seconds, current result will be deleted after three “beep”.
Press the button “START/STOP”, the monitor will turn off.
9. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS
The following guidelines for assessing high blood pressure (without regard to age or gender)
have been established by the World Health Organization (WHO). Please note that other
factors (e.g. diabetes, obesity, smoking, etc.) need to be taken into consideration. Consult with
your physician for accurate assessment, and never change your treatment by yourself.
Note: It is not intended to provide a basis of any type of rush toward emergency
conditions/diagnosis based on the color scheme and that the color scheme is meant only to
discriminate between the different levels of blood pressure.
10. TECHNICAL ALARM DESCRIPTION
The monitor will show 'HI' or 'Lo' as technical alarm on LCD with no delay if the determined
blood pressure (systolic or diastolic) is outside the rated range specified in part
SPECIFICACIONS. In this case, you should consult a physician or check if your operation
violated the instructions.
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The technical alarm condition (outside the rated range) is preset in the factory and cannot be
adjusted or inactivated. This alarm condition is assigned as low priority according to IEC
60601-1-8.
The technical alarm is non-latching and need no reset. The signal displayed on LCD will
disappear automatically after about 8 seconds.
11.
TROUBLESHOOTING (1)
PROBLEM
POSSIBLE CAUSE
SOLUTION
The cuff position was not correct or
Apply the cuff correctly and try
it was not properly tightened
again
Review the “BODY POSTURE
Body posture was not correct during
DURING
testing
sections of the instructions and
LCD Display shows
abnormal result
MEASUREMENT”
re-test.
Speaking, arm or body movement,
Re-test when calm and without
angry, excited or nervous during
speaking or moving during the
testing
test
It is inappropriate for people with
Irregular heartbeat (arrhythmia)
serious arrhythmia to use this
Electronic Sphygmomanometer.
12. TROUBLESHOOTING (2)
PROBLEM
POSSIBLE CAUSE
SOLUTION
LCD shows low battery
Low Battery
Change the batteries
symbol
LCD shows “EE 0”
Pressure system is unstable
before measurement
LCD shows “EE 1”
Don’t move and try again.
Fail to detect systolic pressure
Fail to detect diastolic pressure
Pneumatic system blocked or cuff
LCD shows “EE 2”
is too tight during inflation
Apply the cuff correctly and
Pneumatic system leakage or
try again
cuff is too loose during inflation
LCD shows “EE 3”
More than 3 minutes with cuff
pressure above 15 mmHg
Measure again after five
LCD shows “EE 4”
EEPROM accessing error
minutes. If the monitor is
LCD shows “EE 5”
Device parameter checking error
still abnormal, please
LCD shows “EE 6”
Pressure sensor parameter error
contact the local distributor
LCD shows “EE 8”
Cuff pressure above 300mmHg
or the factory.
LCD shows “EE 7”
Bluetooth Error
No response when you
Incorrect operation or strong
press button or load
electromagnetic interference.
battery.
13/18
Take out batteries for five
minutes, and then reinstall
all batteries.
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Operation Guide
MAINTENANCE
1.
Do not drop this monitor or subject it to strong impact.
2.
Avoid high temperature and solarization. Do not immerse the monitor in water as this
will result in damage to the monitor.
3.
If this monitor is stored near freezing, allow it to acclimate to room temperature before
use.
4.
5.
Do not attempt to disassemble this monitor.
If you do not use the monitor for a long time, please remove the batteries.
6.
It is recommended the performance should be checked every 2 years or after repair.
Please contact the service center.
7.
Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after moistened with
water, diluted disinfectant alcohol, or diluted detergent.
8.
No component can be maintained by user in the monitor. 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
equipment which are designated repairably can be supplied.
9.
The monitor can maintain the safety and performance characteristics for a minimum of
10,000 measurements or three years, and the cuff integrity is maintained after 1,000
open–close cycles of the closure..
10. It is recommended the cuff should be disinfected 2 times every week if needed (For
example, in hospital or in clinique). Wipe the inner side (the side contacts skin) of the cuff
by a soft cloth squeezed after moistened with Ethyl alcohol (75-90%), then dry the cuff by
airing.
EXPLANATION OF SYMBOLS ON UNIT
Symbol for” THE OPERATION GUIDE MUST BE READ”(The sign background colour:
blue.The sign graphical symbol: white)
Symbol for “WARNING”
Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part)
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”
Symbol for “DATE OF MANUFACTURE”
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EC
REP
Operation Guide
47 Spenlow
Bermondsey
London SE16 4SJ
Symbol forHouse
“EUROPEAN
REPRESENTATION”
Symbol for “SERIAL NUMBER”
Symbol for “KEEP DRY”
WARRANTY INFORMATION
Only charge the cost of components and transport.
SERVICE CENTER
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China.
Tel: 86-22-60526081
EC
REP
Lotus Global Co., Ltd.
47
Spenlow House Bermondsey London SE16 4SJ
1 Four Seasons Terrace West Drayton, Middlesex, London, UB7 9GG,United
Kingdom
Tel: +0044-20-75868010
Fax: +0044-20-79006187
IMPORTANT INFORMATION REQUIRED BY THE R&TTE
This product is approved in accordance to R&TTE directive transmitter.
interference
This product complies with Industry Canada. IC: RSS-210
IC NOTICE
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is sub
ject 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.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, In
c and any use of such marks by ANDON HEALTH CO., LTD. is under license.
Other trademarks and trade names are those of their respective owners.
This product is approved in accordance to R&TTE directive transmitter.
Hereby, [ANDON HEALTH CO., LTD.], declares that this [ZRY721 ] is in compliance with the
essential requirements and other relevant provisions of Directive 1999/5/EC. See part
Directive 1999/5/EC declaration of conformity
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1
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Operation Guide
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The ZRY721 is intended for use in the electromagnetic environment specified below.
The customer or the user of the ZRY721 should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
Group 2
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Electromagnetic environment - guidance
The ZRY721 must emit electromagnetic energy in order to perform
its intended function. Nearby electronic equipment may be affected.
The ZRY721 is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Voltage fluctuations/
flicker emissions
Not applicable
IEC 61000-3-3
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The ZRY721 is intended for use in the electromagnetic environment specified below. The customer or the user of the
ZRY721 should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance level
Electromagnetic environment guidance
Electrostatic
± 6 kV contact
± 6 kV contact
Floors should be wood, concrete or
discharge (ESD)
± 8 kV air
± 8 kV air
ceramic tile. If floors are covered with
IEC 61000-4-2
synthetic material, the relative humidity
should be at least 30 %.
Power frequency
3 A/m
3 A/m
Power frequency magnetic fields should
(50/60 Hz)
be at levels characteristic of a typical
magnetic field
location in a typical commercial or hospital
IEC 61000-4-8
environment.
Table 3
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic immunity
The ZRY721 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ZRY721 should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance
Electromagnetic
level
environment - guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the ZRY721,
including cables, than the
recommended separation
distance calculated from the
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equation applicable to the
frequency of the transmitter.
Recommended separation
Radiated RF
3 V/m 80 MHz to 2.5
IEC 61000-4-3
GHz
3 V/m
distance：
：
80 MHz to
d = 1.2 P
800 MHz
d = 2.3 P
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, should be less than
the compliance level in each
frequency range.
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 ZRY721 is used exceeds
the applicable RF compliance level above, the ZRY721 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the ZRY721.
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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 ZRY721
The ZRY721 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ZRY721 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the ZRY721 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
Separation distance according to frequency of transmitter
output
power of
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2,5 GHz
d = 1.2 P
d = 2.3 P
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
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.
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