Trans-Tek LS808-B User manual

User Manual
Blood Pressure Monitor LS808-B
Please do read the user manual carefully and thoroughly so as to ensure
the safe usage of this product, and keep the manual well for your further
reference in case you have problems.
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
LS808-B.
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Arm Type
Version:1.0
Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Contains FCC ID: OU9AW8001-LS

1
INTRODUCTION .............................................................2
Indications for Use
LCD Display Signal
Monitor Components
BEFORE YOU START ........................................................7
MEASUREMENT .............................................................
14
INFORMATION FOR USER .....................................................20
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE....................................................22
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why the blood pressure I get from the hospital is different from home?
If the result is the same if measuring on the right arm?
TROUBLESHOOTING .........................................................24
SPECIFICATIONS ............................................................. 25
ATHORIZED COMPONENT ............................................... 26
CONTACT INFORMATION...................................................... 26
Safety Information
Power Supply and Charge Power
Setting the Time,Date and Unit
Start Measurement
Data Management .................................. 16
Recall the Records
Delete the Records
.........................
COMPLIED STANDARDS LIST 27
...................................................... 29......
Table of Contents
Measurement Principle
General Description
EMC GUDIANCE
TABLE OF CONTENTS
Tie the Cuff
Pair up with Your Device
...............................................
...................................................... 28......FCC STATEMENT

INTRODUCTION INTRODUCTION
FEATURES:
86.1mm×24mm Blue LCD Display with White Backlight
Measure-during-inflating Technology
Up to 60 pieces of record stored
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 deter-
mine 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 to 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 - Wast 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
F1 T1A/250V Φ3.6*10CCC
23
Indications for Use
Symbol for “ Class II Equipment” Symbol for indoor use only
* Thank you for selecting TRANSTEK Blood pressure Monitor (LS808-B).
The monitor features blood pressure measurement, pulse rate measurement
and the result storage. The design provides you with two years of lifetime.
* This manual contains important safety information and caution, and provides step
by step instructions for using the product.
* Please do read this user manual carefully and thoroughly before use.
Contraindications
1.The Transtek Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and hearbeat rate with arm circumference ranging
from 22cm to 42 cm (about 9-17 inches).
2. The monitor detects the appearance of irregular heartbeats during measurement
and gives a warning signal with readings.
3. It is intended for adult use in the home/ domestic setting only.
1. This device is contraindicated for any person who is connected to a wearable
or implantable electronic device or instrument such as a pacemaker or defibrillator.
2. This device is not intended to be a diagnostic device. Contract your physician if
hypertensive values are indicated.
Symbol for “MANUFACTURE
DATE”
Symbol for “Including RF
transmitter”

CAUTION
INTRODUCTION INTRODUCTION
4
LCD Display Signal
Systolic
Blood Pressure High blood pressure
Diastolic
Blood Pressure Low blood pressure
Pulse beat/minute
Unit Measurement unit of blood pressure
Memory Query Recalling the history records
Low Battery Low battery and please charge the power.
IHB Detector Irregular Heartbeat Detector
5
Current time
Shocking reminder
Data pending to
transmit
Year/Month/Day(Hour:Minute)
Shocking will result in inaccurate
Measurement data stored in the device
Data transmitting Data transmission succeeds.
User ID Start measurement for selected user,
and transmit the measuring result
Heartbeat Heartbeat Detection during the
measurement
This device is intended for adult use only.
This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not
intended for use on extremities other than the arm 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.Do not begin or end medical treatment based solely physician for treatment advice.
If you are taking medication,consult your physician to determine the most appropriate time to measure
your blood pressure. Never change a prescribed medication without consulting your Physician.
When the device was used to measure patients who have common arrhythmias such as atrial or
ventricular premature beats or artrial fibrillation, the best result may occure deviation. Please consult
your physician about the result.
If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the
START/STOP button to stop inflation.
The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or nitrous oxide.
The operator shall not touch output of batteries/adaptor and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
The user must check that the equipment functions safely and see that it is in proper working
condition before being used.
This device is contraindicated for any female who may be suspected of, or is pregnant. Besides provided
inaccurate readings, the affects of this device on the fetus are unknown.
Manufacturer will make available on request circuit diagrams, component parts list etc.
This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise,
the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
Please use the device under the environment which was provided in the user manual. Otherwise, the
performance and lifetime of the device will been impacted and reduced.
During using, the patient will contact with the cuff. The materials of the cuff have been tested and found
to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential
sensization or irritation reaction.
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, its adaptor, 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.
Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts
is dangerous or even fata.
The adaptor is specified as a part of ME equipment.
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.
The device is not suitable for public use.
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.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.

Monitor Components
List
1.Blood Pressure Monitor
(LS808-B)
2.AC Adaptor
( Model: UE08WCP- 060100SPA)
3.User Manual
BEFORE YOU START
6
1. The battery of LS808-B is built-in rechargeable
li-polymer battery, the battery current is 1000 mAh.
2. Please use the AC adaptor 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.
AC adaptor
CAUTION
1. The battery of LS808-B is built-in rechargeable li-polymer battery,
please do not disassemble it by the unauthorized maintenance personel.
2. Under the normal using, it can charge power about 300 times,
if the battery cannot charge the power normally or the blood pressure
monitor cannot use 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. Storge and use the blood pressure monitor at the cool, dry and
ventilated environment. Avoid to approach to the fire and the heat
source, or it will cause the battery explode.
4. Only can use the Transtek’s authorized AC Adaptor
(Model: UE08WCP-060100SPA) to charge the power. You cannot
use the blood pressure monitor during the process of charging.
5. During the process of charging, the blood pressure monitor display
When the charging is finished, please pull the plug in time.
6. When charging, shall not touch charging connector and the patient
simultaneously. 7
4. Cuff (22-42cm) (Type BF Applied Part)
INTRODUCTION
(Please use TRANSTEK
authorized cuff.)
Component list of
pressure measuring system
1 PCBA
2 Air pipe
3 Pump
4 Valve
5 Cuff
CUFF
(Type BF applied part)
SYSTOLIC PRESSURE
DIASTOLIC PRESSURE
QUERY/UP
BUTTON
USER 2/ACTIVATION
BUTTON
USER 1/SET
BUTTON
PULSE RATE
ON/OFF BUTTON
DC POWER SOCKET

Setting the Time,Date and Unit
(1) When the monitor is off, press and hold User 1 button for 3s
to enter Time Setting Mode.
To ensure the stored measurement result has correct time
record, please set time and unit before device is used.
BEFORE YOU START
8
9
BEFORE YOU START
(2) As pictured in the right, the blinking numeral representing [HOUR].
Press “Query” button to change the numeral. Each press will increase
the numeral by one in a cycling manner.
(3) Press “User 1” button again to confirm [HOUR]. Then the numeral
representing [MINUTE] blinks.
(4) Repeat step 2 and 3 to confirm [MINUTE].
Before use,switch the button to the “ON” side to turn on the monitor.
Note: If the button is on the “OFF” side, there is no reaction
when you press any button.

10 11
BEFORE YOU START BEFORE YOU START
(5) Repeat step 2 and 3 to confirm[MONTH], [DAY] and [YEAR].
(6) Repeat step 2 and 3 to confirm the measurement unit.
(7) After confirming the measurement unit, the LCD will
display “dOnE” and the monitor will shut off.

12 13
BEFORE YOU START BEFORE YOU START
Tie the Cuff
Resting for 5 minutes before measuring.
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 measurementsat approximatelythe same time, on the same
arm, or as directed by a physician.
1. Remove all accessories from your left arm.
If your physician has diagnosed you with poor
circulation in your left arm, use your right arm.
2. Roll or push up your sleeve to expose the skin.
3. Apply the cuff to your left arm with your palm facing up.
4. Position the edge of the cuff about 2-3 cm.
5. Fasten the arm cuff around your arm, leaving no extra room
between the cuff and your skin. If the cuff is too loose, the
measurement will not be accurate.
6. Correct Posture for Patients with Hypertension, especially for
Hypertension patient
- Bare your arm or wear tights only when starting measurement.
- Sit comfortably with legs uncrossed, feet flat on the floor, back
and arm supported.
The central of the cuff should maintain at the same level as the
right atrium of the heart.
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 User 2
button to start pair-up. The symbol and the symbol
will be shown on the LCD alternatively, indicating
pair-up is proceeding.
If succeed, symbol will be shown on the LCD.
If fail, symbol will be shown on the LCD.
(3) The monitor will shut off automatically after pair-up
process is complete.
CAUTION
Interference may occur in the vicinity of equipment marked with the following symbol
. And LS808-B may interfering vicinity electrical equipment.
Keep the monitor at least 20 centimeters 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. Please ensure 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 away from the monitor.
Bluetooth Module No. : AW8001
Frequency Range
Output Power Range
Supply Voltage2.402 - 2.480 GHz
0 dBm
1.8-3.6 V
Transmitting Distance 10 meters

14 15
Start Measurement
MEASUREMENT MEASUREMENT
When the monitor is off, press User 1 button to turn
on the monitor and it will finish the whole measurement,
and then save the measure data for User 1.
The same to the User 2.
(1) When the monitor is off, press the User 1 button
to turn on the monitor.
LCD display Adjust to zero.
Inflating and measuring. Display and save the results.
The data transmission will proceed.
(2) Press User 1 button to power off,
otherwise it will turn off with one minute.
Tips:
A. When finish the whole measurement, press another
user button, the blood monitor will begin measuring again.
B. Maximum 60 records are both for user 1 and user 2.
1.With LS808-B successfully pair-up with your iPhone, the
measurement data will be automatically transmitted to
your mobile via Bluetooth.
2.The symbol will disappear after successful data
transmission, and you may check your personal health
data stored in your iPhone.
3.If the data transmission fails, the symbol will remain.
The pending measurement data will be transmitted to
your iPhone when next measurement is complete.
CAUTION

16 17
DATA MANAGEMENT
Recall the Records
(1) When the monitor is off, press “Query” button
to access the memory.
(2) The LCD will display the latest measuring
result of the user ID which completes the last
measurement.
The record number, measuring date and measuring
time will be displayed alternatively.
(3) Press “Query” button to rotate the history records.
(4) When in the memory mode, press the User 1 button
to recall the measurement history of User 1, or press
the User 2 button to recall the measurement history.
(5) When no history stored for the specific user in the
monitor, press “Query” button and the LCD will display
as pictured to the right.
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

1918
Delete the Records
DATA MANAGEMENT DATA MANAGEMENT
(1) When under the query mode, press and hold
“Query” button for 3 seconds to clear the memory.
(2) When the LCD display “dEL ALL”, press “Query”
button to confirm.
(3) The LCD will display “dEL dOnE” and then shut off.
(4) If you wish to stop clearing the memory, you may
press the other button, rather than “Query” button to
turn off the monitor, or wait until the monitor shuts off.
CAUTION
1. When using this device, please pay attention to the following situation 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 itspressurization on any arm where intravascular
access or therapy, or an arterio-venous (A-V) shunt, is present;
Inflating the cuff on the arm 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 case to result in prolonged impairment of the circulation of the blood of
the PATIENT.
5. Don’t kink the connection tube, otherwise, the cuff pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.

Tips for Measurement
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
It can cause inaccuracy if the measurement is taken in the following
circumstances.
Maintenance
20 21
INFORMATION FOR USERINFORMATION FOR USER
To obtain the best performance, please follow below instructions.
Put in a dry place and
avoid the sunshine
Avoid shaking and collision.
Use the slightly damp cloth
to remove the dirt.
Avoid immersing it in the water.
Clean it with a dry cloth in case.
Avoid dusty environment and
unstable temperature surrounding
Avoid washing the cuff
Please use ACCESSORIES and detachable partes specified/ authorised by
MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
The device doesn’t need to be calibrated in two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to
the local guidelines.
If you have any problems with this device, such as setting up, maintaining or using, please
contact with SERVICE PERSONNEL of Transtek. Don’t open or repair the device by
yourself.
Please report to Transtek if any unexpected operation or events occur.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
CAUTION

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.
1. Individual blood pressure varies
every in one day, it is also affected
by the way you tie your cuff and the
your measurement position, so please
take the measurement at the same condition.
Why does my blood pressure
fluctuate throughout the day?
2. The varies of the pressure is greater if the
person take medicine.
3. Waiting at least 3 minutes for another
measurement.
The blood pressure is different even
during 24 hour because of the weather,
emotion, exercise etc, specially the
“white coat” in hospital which makes
the results are higher than the ones at
home.
Why the blood pressure
I get from the hospital is
different from home?
It is ok for both arms, but there will be
some different results for different arm,
so suggest you measure the same arm
every time.
If the result is the same
if measuring on the
right arm?
The attention need to pay
when you measure your
blood pressure at home:
If the cuff is tie properly.
If the cuff is too tight or too loose.
If the cuff is tied on the upper arm.
If you feel anxious pressured.
You had better take deep breath
2-3 times before beginning.
Advice: adjust yourself for 4-5 minutes
until you calm down.
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE
22 23
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 measuring result falls outside the range.
Kindly note that only a physician could 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.

This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
massage
Display will not
light up.
E1 shows
The cuff is not secure.E 3 shows
Relax for a moment
and then measure again.
E 10 or
E 11 shows
The monitor detected
motion,talking or the
pulse is too poor while
measuring.
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.
The treatment of the
measurement failed.
Power is exhausted. Charge the power
Power is low. Charge the power
Power supply 3.7V 1000mAH Built-in rechargeable li-polymer
battery, 6V 1A AC Adaptor
Display moder Blue LCD with White Backlight
V.A.= 86.1mm(L) x24mm(W)
Measurement mode Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm About 22cm-42cm
Net Weight Approx.265 g
External dimensions
Attachment
Approx.130.9mm×73mm×29.4mm
AC Adaptor,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℃
Relative humidity: 10%RH to 93%RH
Atmospheric pressure: 50kPa to 106kPa
Temperature:5℃to 40℃
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
AC Adaptor charged Mode:
Class II ME Equipment
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
TROUBLESHOOTING SPECIFICATIONS
24 25
Refasten the cuff and
relax for a moment and
then measure again.
Communication error
Check if the App is on or
not,try data transmission
again.
Display is dim or
shows

For more information about our products, please visit www.transtek.cn.you
can get customer service, usual problems and customer download, transtek
will serve you anytime.
Contact Information
Manufactured by: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Company: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Address: Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Athorized Component
Please use the TRANSTEK
authorized adaptor
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
IIEC/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
ISO 81060-2:2009 Non-invasive sphygmomanometers -
Part 2 : Clinical validation of automated measurement type
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
ATHORIZED COMPONENT
COMPLIED STANDARDS LIST
26 27
UE08WCP-060100SPA
100-240V 50-60Hz,400mA
6V 1A
Adaptor
Type:
Input:
Output:
(Conforms to UL Certification)

EMC Guidance
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)
EMC GUIDANCE
28
FCC STATEMENT
FCC Statement
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.
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.
29