IC Sciences LS-810-B User manual

User Manual
Blood Pressure Monitor LS810-B
Please read this user manual carefully and thoroughly to ensure
safe usage of this product. Keep this manual for further reference
in case you have problems.
Thank you for selecting the IC Sciences Corporation Blood
Pressure Monitor LS810-B.
Wrist Type
Version:1.0
MEM
SET
FCC ID: OU9LS810-B01
Distributed by:
Informed Clinical Sciences Corporation
1 Joy Street, Boston, USA MA 02108
Download and install My BP Coach
from iTunes Store or Google play
My BP Coach

1
INTRODUCTION .............................................................
2
Indications for Use
LCD Display Signal
Monitor Components
BEFORE YOU START
........................................................
6
MEASUREMENT
.............................................................
9
INFORMATION FOR USER..................................................... 16
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE.................................................... 18
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why is the blood pressure I get from the hospital different from home?
Is the result the same if measuring on the right wrist?
TROUBLESHOOTING ......................................................... 20
SPECIFICATIONS ............................................................. 21
THE MATCHED COMPONENTS ............................................... 22
CONTACT INFORMATION...................................................... 22
Safety Information
Power Supply and Charge Power
Activate Your Blood Pressure Monitor
Setting Date and Time
Positioning the Cuff
Start Measurement
Data Management ..................................
14
Recall the Records
Delete the Records
.........................
COMPLIED STANDARDS LIST ........................ 23
FCC STATEMENT ...................................................... 24......
Pair up the Blood Pressure Monitor with Your Device
Table of Contents
...............
Measurement Principle
General Description
EMC GUDIANCE ...................................................... 25......
Table of Contents

INTRODUCTION INTRODUCTION
Thank you for selecting IC Sciences Corporation’s Blood Pressure Monitor
(LS810-B). The monitor features blood pressure measurement, pulse rate
measurement and the data storage. The design provides you with two
years of storage.
This
manual contains important safety and care informatiion and
provides step-by-step instructions for using the product.
Please read this user manual carefully and thoroughly before use.
FEATURES:
Systolic Blood Pressure
Diastolic Blood Pressure
Pulse Rate
Memory: Up to 60 records
This product uses the Oscillometric Measuring Method to detect blood pressure.
Before every measurement, the unit establishes a “zero point” equivalent to the
atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit
detects pressure oscillation generated by beat-to-beat pulsatile, which is used
to determine the systolic pressure and diastolic pressure as well as pulse rate.
The device also compares the longest and the shortest intervals of detected
pulse wave with the average value, and then calculates the standard deviation.
The monitor will light up a warning symbol when the calculated standard
deviation is larger than or equal to 15.
Measurement Principle
General Description
The below signs might be in the user manual, labeling or other components.
They are the requirement of standard and using.
Safety Information
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
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”
The Bluetooth Combination Mark
Symbol for “MANUFACTURE
DATE”
23
Indications for use
The IC Sciences Corporation Blood Pressure Monitor is a digital
monitor intended for use in measuring blood pressure and heartbeat rate with
wrist circumference ranging from 13.5 cm to 21.5 cm ( about 5-8.5 inches ).
It is intended for adult indoor use only.
Symbol for “ Class II Equipment”
CAUTION
* It is intended for adult indoor use only. Pregnant women, pre-eclamptic patients,
and severely obese patients should not use the device. If you need to measure your blood
pressure, please consult your physician.
* This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is
not intended for use on extremities other than the wrist or for functions other than obtaining a
blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood
pressure. Please start or end medical treatment basing solely on physician’s treatment advice.
* If you are taking medication, consult your physician to determine the most appropriate time for
your measurement. Never change a prescribed medication without your physician’s consent.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.
Otherwise, the patient’s wrist and fingers will become anaesthetic, swollen, and even purple due
to a lack of blood.
* If the pressure of the cuff exceeds 40 kPa (300 mmHg), the unit will automatically deflate. If the
cuff doesn’t deflate when its pressure exceeds 40 kPa (300 mmHg), detach the cuff from the wrist
and press the START/STOP button to stop inflation.
* Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RF
equipment) that radiates interference signal or electrial fast transient/ burst signal.
* The maximum temperature that the applied part can be achieved is 42.5℃ (108.5 F) while the
environmental temperature is 40℃ (104 F).
* The device is not AP/APG equipment. It is not suitable for use in the presence of a flammable
anesthetic mixture with air (or oxygen, nitrous oxide).
* Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of
small parts is dangerous or even fatal.
* Please use ACCESSORIES and detachable parts specified / authorised by MANUFACTURER.
Otherwise, it may cause damage to the unit or danger to the user / patient.
* The patient is an intended operator. The patient can measure, transmit data and charge battery
under normal circumstances and maintain the device and its accessories according to the user
manual.
* The blood pressure monitor, and the cuff are suitable for use within the patient
environment. If you are allergic to dacron or plastic, please don’t use this device.
* The device is not intended for PATIENT transport outside a healthcare facility.
*This device cannot be used with HF surgical equipment at the same time.
* There is a PTC current limiter in the monitor, which specification is 8V and 0.5A. When the voltage
and current exceed the limiting value, the monitor will stop working.
* If Luer lock connectors are used in the construction of tubing, there is a possibility that they might
be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood
vessel.
* Be careful of strangulation due to cables and hoses, particularly due to excessive length.
Symbol for “Including RF
transmitter”
Readings taken by the LS810-B are equivalent to those obtained by a trained
observer using the cuff and stethoscope auscultation method.

INTRODUCTION INTRODUCTION
4
LCD Display Signal
Systolic
Blood Pressure Top number in your blood pressure
Diastolic
Blood Pressure Bottom number in your blood pressure
Pulse beat/minute
Unit Measurement unit of blood pressure
Time Hour:Minute (Month/Day/Year)
Low Battery Low battery; please charge the power.
Error
Memory Recalling the history records
Bluetooth Successful Bluetooth Connection
IHB Detector Irregular Heartbeat Detector
Error
5
SYSTOLIC
DIASTOLIC
MEM/UP
BUTTON
SET/DOWN
BUTTON
START/STOP BUTTON
CUFF
(Type BF applied part)
PULSE RATE
TIME
USB Interface
Monitor Components
List
1.Blood Pressure Monitor
(LS810-B)
2.USB Cable
3.User Manual
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Component list of
pressure measuring system
1 PCBA
2 Air pipe
3 Pump
4 Valve
5 Cuff
Heartbeat Heartbeat detection during the
measurement

BEFORE YOU START BEFORE YOU START
6
1. The battery of LS810-B is a built-in rechargeable
lithium-ion battery, the battery current is 420 mAh.
2. Please use the USB cable to charge
the battery, just like the following picture:
Power Supply and Charge Power
Charging the power under following circumstances:
displays on the LCD
The LCD display dims
When powering on the monitor, the LCD doesn’t light up.
CAUTION
1. The battery of the LS810-B is a built-in rechargeable lithium-ion battery;
please do not disassemble by unauthorized maintenance personel.
2. Under normal use, it can be charged about 300 times.
If the battery cannot charge the power normally or the blood pressure
monitor cannot be used normally, please connect with the authorized
maintenance personel. If measured three times per day, and the battery
is fully charged, it can be used for about 20 days.
3. Store and use the blood pressure monitor in a cool, dry, and
ventilated environment. Avoid close proximity to fire and extreme heat
or it can cause the battery to explode.
4. You can only use the IC Science’s authorized USB cable to
charge the power. You cannot use the blood pressure monitor during
charging.
5. During charging, the blood pressure monitor displays the symbol:
When the charging is finished, please unplug the device.
6. When charging, do not touch the charging connector and the patient
simultaneously.
7
Setting Date and Time
2.As pictured in the right, the
blinking numeral representing
[HOUR]. Press “MEM” button to
change the numeral. Each press
will increase the numeral by one
in a cycling manner.
1.When the monitor is OFF, press
and hold “SET” button for 3
seconds to enter Time Setting
Mode.
3.Press “SET” button again to
confirm [HOUR]. Then the
numeral representing [MINUTE]
blinks.
Please proceed to time setting before your initial use to
ensure each piece of recorded information is labled with a
time stamp. (Year Range: 2012-2052; Time Format: 12 Hours)
When you get the Blood Pressure Monitor, the first thing
you must do is to activate it. Please press and hold the SET
button to activate it, then it will enter the setting mode.
Activate Your Blood Pressure Monitor
Download and install My BP Coach from
iTunes Store or Google play

BEFORE YOU START MEASUREMENT
8
4.Repeat step 2 and 3 to confirm
[MINUTE].
5.Repeat step 2 and 3
to confirm [MONTH],
[DAY] and [YEAR].
6.After confirming [YEAR], the LCD
will display “dONE” and the
monitor will shut off.
9
Positioning the Cuff
1.Remove all accessories (watch, bracelet, etc) from your left wrist. If your
physician has diagnosed you with poor circulation in your left wrist, use your
right wrist.
2.Roll or push up your sleeve to expose the skin.
3.Apply the cuff to your left wrist with your palm facing up.
4. Position the edge of the cuff about 1-2 cm (1 inch) from the bottom of the wrist.
5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff
and your skin. If the cuff is too loose, the measurement will not be accurate.
Rest for 5 minutes before measuring your blood pressure.
Wait at least 3 minutes between measurements. This allows your blood
circulation to recover.
For a meaningful comparison, try to measure under similar conditions. For
example, take daily measurements at approximatelythe same time, on the
same wrist, or as directed by a physician.
6.Patients with Hypertension:
The middle of the cuff should be at the level to the right atrium of the heart.
Before starting measurement, please sit comfortably with legs uncrossed,
feet flat on the floor, back and arm supported.
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MEASUREMENT MEASUREMENT
10
Pair-up the Blood Pressure Monitor
with Your Device
1.Turn on Bluetooth and the app.
Make sure both are ON when
pair-up is proceeding.
2.When the monitor is OFF, press and
hold the START button to start
pair-up. The symbol and the
symbol will be shown on the
LCD alternatively, indicating pair-up
is proceeding.
If SUCCESSFUL, symbol will
be shown on the LCD.
If FAIL, symbol will be
shown on the LCD.
3.The monitor will shut off
after Pair-up process is complete.
Bluetooth Module No.: AW2540MV1
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range: -1 dBm
Supply Voltage: 2 V to 3.6 V
Transmitting Distance: 10 meters
11
START
STOP
1.After correctly positioning the cuff,
press the START button to turn on the
monitor, and it will complete the
measurement process.
Start Measurement
CAUTION
Interference may occur in the vicinity of equipment marked with the
following symbol . And LS810-B may interfere in the vicinity of
electrical equipment.
Keep the monitor at least 20 centimeters (8 inches) away from the human
body (especially the head) when the data transmission is proceeding after
measurement.
To enable the data transmission function, this product should be paired to
Bluetooth end at 2.4 GHz.
How to mitigate possible interference?
1. The range between the device and BT end should be reasonably close,
from 1 meter to 10 meters (from 3 ft to 32 ft). Please ensure there are
no obstacles between the device and BT end so as to obtain quality
connection and to lower the RF output range.
2. To avoid interference, other electronic devices (particularly those with
wireless transmission / Transmitter) should be kept at least 1 meter
(3 ft) away from the monitor.

Adjust to zero.
Inflating and measuring. Display and save the
measuring result.
MEASUREMENT
12
START
STOP
4. Press STOP button to turn off
the monitor. Otherwise it will
power off.
2.This device will proceed
to transmit data
after measurement.
The Bluetooth symbol
blinking on the LCD
indicates data is
transmitting.
3. If the data is successfully
transmitted, the LCD will then
display “dONE”.
If the data transmission fails, the
LCD will display “ ” instead.
13
CAUTION
5. Do not kink the connection tube; otherwise, the cuff pressure may
continuously increase, which can prevent blood flow and result in harmful
injury to the PATIENT. Sensitive people, including pregnant women, pre-
eclamptic patients, patients with implanted medical electronic devices;
and those who have have atrial fibrillation (AF), premature ventricular beats
and peripheralarterial disease (PAD), should avoid using the unit whenever
possible.
1. When using this device, please pay attention to the following situations
which may interrupt blood flow and influence blood circulation of the patient,
thus cause harmful injury to the patient: too frequent and consecutive multiple
measurements; the application of the CUFF and its pressurization on any wrist
where intravascular, access or therapy, or an arterio-venous (A-V) shunt, is
present; Inflating the cuff on the wrist on the side of a mastectomy.
2. Do not apply the cuff over a wound, otherwise it can cause further injury.
3. Do not inflate the cuff on the same limb which other monitoring ME
EQUIPMENT is applied around simultaneously, because this could cause
temporary loss of function of those simultaneously used monitoring ME
EQUIPMENT.
4. Using it in situations that can result in prolonged impairment of the
circulation of the blood of the PATIENT.
MEASUREMENT

Recall the Records
1.Press “MEM” button to access the
memory. The monitor will display the
calculated value of the most recent
readings first.
2. Press “MEM/UP” button or
“SET/DOWN” button to rotate the
history records.
“MEM/UP” to go forward;
“SET/DOWN” to go backward.
The most recent record (1) is shown first. Each new measurement
is assigned to the first (1) record. All other records are pushed back
one digit (e.g., 2 becomes 3, and so on), and the last record (60) is
dropped from the list.
CAUTION
DATA MANAGEMENT
14
When you did not obtain an accurate measurement, you can clear all the
results by following the steps below.
Delete the Records
1.Under Memory Recalling Mode, press
and hold both the “MEM” button and the
“SET” button for 3 seconds.
2.The LCD will display “dEL dONE”,
indicating that memory clearing is
complete. Then it will shutdown.
To cancel the clearing process in
Memory Recalling Mode, press
“START/STOP” to turn off the monitor.
3.When there is no memory in the monitor,
if you press the “MEM” button to look up
history, the LCD will display as pictured
to the right.
CAUTION
15
DATA MANAGEMENT

Tips for Measurement
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediately measuring
after tea, coffee, smoking
When talking or moving your fingers
When you need to urinate
Your readings may be innaccurate if the measurement is taken in
the following circumstances.
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16
Maintenance
To obtain the best performance, please follow the tips below.
Store and use in a dry place and
avoid direct sunshine
Avoid shaking and dropping.
Use a slightly damp cloth
to remove dirt.
Avoid immersing it in water.
Clean with a dry cloth if it gets wet.
Avoid a dusty environment
and unstable temperature
Avoid washing the cuff
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CAUTION
1. Please make sure the unit functions safely and it is in proper working conditions before use.
Don’t service or maintain while the device is in use.
2. If you have any problems with this device, such as setting up, maintaining or using, please
contact Informed Clinical Sciences. Do not open or repair the device yourself.
3. Please report to Informed Clinical Sciences if any unexpected operation or events occur.
4. Cleaning: A dusty environment may affect the performance of the unit. Please use a soft
cloth to remove the dirt from the device and cuff before and after use.
5. Calibration: The manufacturer does not require such preventive inspections or calibration by
other persons and will make available on request of circuit diagrams, component part list, etc.
6. Disposal: Degraded sensors may result in inaccurate measurement while loosened electrodes
may cause the monitor’s failure to power on. Please dispose of ACCESSORIES, detachable
parts, and ME EQUIPMENT according to local guidelines.
17
INFORMATION FOR USER
INFORMATION FOR USER

What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
What is the standard blood pressure classification?
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
maximum value in the cycle, which is called
systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum
value in the cycle, which is called diastolic
pressure.
Irregular Heartbeat Detector
This Blood Pressure Monitor is equipped with an intelligent function of Irregular
Heartbeat (IHB) Detector. During each measurement, this equipment records
the heartbeat intervals and works out the standard deviation. If the calculated
value is larger than or equal to 15, this equipment will light up the IHB symbol
on the screen when displaying the measuring result.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent
with an irregular heartbeat was detected during measurement. Usually this is
NOT a cause for concern. However, if the symbol appears often, we
recommend you seek medical advice. Please note that the device does not
replace a cardiac examination, but serves to detect pulse irregularities at an
early stage.
1918
The chart on the right is the
standard blood pressure classifi-
cation published by American
Heart Association (AHA).
AHA Home Guideline for
Upper Limit of Normal BP
Please consult a physician if your result fall outside the range.
Only a physician can tell whether your blood pressure value has reached
a dangerous point.
CAUTION
SYS 135 mm Hg
DIA 85 mm Hg
Blood Pressure Category
Normal
Prehypertension
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
120-139
140-159
160 or higher
Higher than 180
and
or
or
or
or
less than 80
80-89
90-99
100 or higher
Higher than 110
This chart reflects blood pressure categories defined by American Heart Association.
1. Individual blood pressure varies
throughout the da,y. It is also affected by
w a y y o u t i e y o u r c u f f a n d y o u r
measurement position, so please take
the measurement in the same position.
Why does my blood pressure
vary even in one day?
Why are blood pressure
measurements taken
in the hospital
different than those
taken at home?
If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the wrist.
If you feel anxious or pressured.
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MEM
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ABOUT BLOOD PRESSURE
ABOUT BLOOD PRESSURE
2. Blood pressure varies even more
when you’re on medication.
3. Wait at least 3 minutes to take your
blood pressure again.
Blood pressure can vary throughout the
day because of stress, foods eaten,
exercise, even “white coat” syndrome at
your doctor’s office or in the hospital,
which can make your blood pressure
results higher than readings taken at
home.
Are the results the
same if measured on
the right wrist?
It is OK to measure your blood pressure
on both wrists; however, the results may
differ. It is suggested that you measure
with the same wrist each time.
When taking your blood
pressure at home, be sure to
check:
Tips:
Take 2 to 3 deep breaths before you
begin.
Sit quietly for 4 to 5 minutes to relax
before beginning.

PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
massage
Display is dim or
will not light up.
Show on
the display
shows Data communication
has failed
Make sure that the phone’s
Bluetooth is on or within
the distance range
E 2 shows The cuff is very tight Refasten the cuff and then
measure again.
E 3 shows The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
E 9 shows Product has not been
activated. Reactivate
E 10 or
E 11 shows
The monitor detected
motion while measuring.
Movement can affect the
measurement. Relax for a
moment and then
measure again.
E 20 shows
E 21 shows Relax for a moment and
then measure again.
EExx,shows on
the display.
A calibration error
occurred.
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance. Refer to the
warranty for contact
information and return
instructions.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on
the arm and then
measure again.
Measure incorrectly.
Power is exhausted. Charge the device
Power is low. Charge the device
20
Power supply 3.7V 420mAH Built-in rechargeable lithium-ion
battery, 5V / 1A USB cable
Display moder Digital LCD V.A.46.5x36.5mm
Measurement mode Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the wrist About 13.5cm-21.5cm
Net Weight Approx.110g
External dimensions
Attachment
Approx.79.8×72.5×13.2mm
USB cable,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
IP22, It means the device could protected
against solid foreign objects of 12.5 mm and
greater, and against vertically falling water
drops when ENCLOSURE tilted up to 15°
Software version
Device classification
V01
Battery Powered Mode:
Internally Powered ME Equipment
WARNING: No modification of this equipment is allowed.
Rated cuff pressure:
0kpa-40kpa (0mmHg-300mmHg)
pulse value:(40-199)beat/minute
Pressure:
5℃-40℃within±0.4kpa(3mmHg)
pulse value:±5%
Temperature:-20℃to 60℃ RH: 10% to 93%
Atmospheric pressure: 50kPa to 106kPa
Temperature:5℃to 40℃ Relative humidity ≤85%
Atmospheric pressure: 86kPa to 106kPa
AC Adaptor charged Mode:
Class II ME Equipment
21
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
SPECIFICATIONS
TROUBLESHOOTING
This section includes a list of error messages and frequently asked
questions for problems you may encounter with your pressure
monitor. If the product is not operating as you think it should,
check here before arranging for service.

For more information about our products, please visit www.icsciences.com.
Contact Information
Manufactured by: Informed Clinical Sciences Corporation
Address: 1 Joy Street, Boston, MA 02108
22
23
Please use the IC SCIENCES
authorized adaptor
(Not Included)
UE05WCP-050100SPC
100-240V, 50-60Hz,0.18A
5.0V 1.0A
Adaptor
Type:
Input:
Output:
Complied Standards List
COMPLIED STANDARDS LIST
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be
used with medical device labels, labelling and information to
be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
IEC/EN 60601-1-2:2007 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 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
CONTACT INFORMATION
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated sphygmomanometers
The Matched Component

FCC Statement
NOTE: 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.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with
any other antenna or transmitter.
EMC Guidance
24 25
1.The Blood Pressure Monitor needs special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided in the ACCOMPANYING DOCUMENTS
2. Wireless communications equipment such as wireless home
network devices, mobile phones, cordless telephones and their base
stations, walkie-talkies can affect this equipment and should be kept
at least a distance d = 3,3 m away from the equipment.
(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME
EQUIPMENT, a typical cell phone with a maximum output power of 2
W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)
FCC STATEMENT EMC GUIDANCE
This device complies with Part 15 of the FCC Rules. 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.
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible for compliance could void
the user's authority to operate the equipment.