IC Sciences TMB-1018-BT User manual

User Manual
IC Sciences Blood Pressure Arm Cuff Monitor
TMB-1018-BT
Manufactured for
Informed Clinical Sciences Corporation
1 Joy Street
Boston, MA USA 02108
www.icsciences.com
Version:1.0
Arm Type
Please read the user manual carefully and thoroughly to ensure safe
usage of this product, and keep the manual available for future reference.
Thank you for selecting the IC Sciences Blood Pressure Arm Cuff Monitor
TMB-1018-BT.
Contains FCC ID: OU9AW8001-LS
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China

1
INTRODUCTION ............................................................... 2
General Description
Indications For Use
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START ...........................................................6
Power Supply
Installing and Replacing the Batteries
Apply the Cuff
Settings
Select User ID
Pair-up the Blood Pressure Monitor with Your Device
DATA MANAGEMENT ...........................................................12
Recall the Records
Delete the Records
Transmitting Data
INFORMATION FOR USER.......................................................14
Tips for Measurement
Maintenance
START MEASUREMENT...........................................................11
Start Measurement
TABLE OF CONTENTS
ABOUT BLOOD PRESSURE.......................................................16
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why are measurements taken in hospital different from at home?
Is the result the same when measuring on the right arm?
TROUBLESHOOTING .......................................................18
SPECIFICATIONS .......................................................19
AUTHORIZED COMPONENT.......................................................20
COMPLIED STANDARDS LIST ........................................20
FCC STATEMENT .......................................................21
EMC GUDIANCE .......................................................21
Table of Contents
Contraindications

Thank you for selecting the IC Sciences Blood Pressure Arm Monitor (TMB-1018-BT).
The monitor features blood pressure measurement, pulse rate measurement and
the data storage. The design provides you with two years of storage.
Readings taken by the TMB-1018-BT are equivalent to those obtained by a trained
observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step-by-step
instruction for using the product.
Read the manual thoroughly before using the product.
Features:
Blue LCD display with white backlight
Up to 60 pieces of recorded data stored for each user
Measuring While Inflating (MWI) technology
Bluetooth data transmitting function
This product uses the Oscillometric Measuring method to detect blood pressure.
Before every measurement, the unit establishes a “zero pressure” equivalent to
the air pressure.Then it starts inflating the arm cuff; meanwhile, the unit detects
pressure oscillations generated by beat-to-beat pulsatile, which is used to determine
the systolic and diastolic pressure and pulse rate.The device also compares
the longest and the shortest time intervals of detected pulse waves to mean time
interval then calculates standard deviation.The device will display a warning signal
with the reading to indicate the detection of irregular heartbeat when the difference
of the time intervals over.
INTRODUCTIONINTRODUCTION
The symbols below might be in the user manual, on labeling, or
other components.
Safety Information
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION – Waste electrical
products should not be disposed of
with household waste. Please follow
local guidelines.”
Symbol for “DIRECT CURRENT”
This device is intended for adult use in the home/domestic only.
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 upper 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 start or end medical treatment without a physician’s consent.
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.
If the pressure of the cuff exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the
cuff not deflate when its pressure exceeds 40 kPa (300 mmHg), detach the cuff from the upper arm
and press the homologous button to stop inflation.
Please read this user manual carefully and thoroughly before use.
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).
Do not touch the output of batteries and the patient simultaneously.
Do not use the monitor under the conditions of strong electromagnetic field (e.g. mobile) that radiates
interference signal or electrical fast transient / burst signal, especially when the AC adaptor is applied.
Please keep the unit out of reach of infants or children, since inhalation or swallowing of small parts
is dangerous or even fatal.
CAUTION
Please use ACCESSORIES and detachable parts specified / authorised by IC Sciences.
Otherwise, it may cause damage to the unit or danger to the user / patient.
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 alergic reaction or contact injury.
Please make sure the unit functions safely and it is in proper working conditions before use.
The Bluetooth Combination Mark
Symbol for “THE OPERATION
GUIDE MUST BE READ”
2 3
General Description
Indications For Use
Measurement Principle
Symbol for “MANUFACTURE
DATE”
Contraindications
1.The IC Sciences Blood Pressure Arm Monitor is a digital monitor intended for
measuring blood pressure and heartbeat rate for people with an arm circumference
ranging from 22cm to 42 cm (about 8.66-16.5 inches).
2. The monitor detects irregular heartbeats during measurement and gives a
warning signal with readings.
3. It is intended for adult use in the home setting only.
1. The device is contraindicated for any person connected to a wearable or
implantable electronic device or instrument such as a pacemaker or defibrillator.
2. The device is not intended to be a diagnostic device. Contact your
physician if hypertensive values are indicated.
Symbol for “Including RF
transmitter”

INTRODUCTION INTRODUCTION
4
LCD Display Signal Monitor Components
5
SYMBOL DESCRIPTION EXPLANATION
Systolic Blood Pressure Top number
Diastolic Blood Pressure Bottom number
Pulse beat/minute
User 1 Start measurement for user 1, save and
transmit the measuring result automatically.
User 2 Start measurement for user 2, save and
transmit the measuring result automatically.
Successful Bluetooth
Connection
Low Battery Low battery; replace the batteries.
Unit Measurement unit of blood pressure
Error
Memory Review Mode
Average Value
Current Time Month:Day (Hour:Minute)
Irregular Heartbeat
Detector
Indicate the current mode is memory review
mode, and which group of memory it is.
Bluetooth is turned on.
Detects irregular heart beats.
Average value of latest three records.
The monitor detects error.
AIR CONNECTOR PLUG
List
1.Blood Pressure Monitor
(TMB-1018-BT)
4.User manual
3. 4×AAA batteries
2.Cuff (Type BF Applied Part) (22cm-42cm)
BATTERY COMPARTMENT
CUFF
AIR HOSE
LCD DISPLAY
DC POWER SOCKET
MEM/DOWN BUTTON
START/STOP BUTTON
SET/UP BUTTON
(Please use IC Sciences' authorized cuff)
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve

BEFORE YOU START
Power Supply
Installing and Replacing the Batteries
1. Open the battery door.
2. Insert the batteries according to the polarity
indications.
3. Close the battery door.
Replace the batteries under following circumstances:
displays on the LCD.
The LCD display dims.
When powering on the monitor, the LCD doesn’t light up.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not dispose with daily garbage.
Remove the old batteries from the device following your local recycling guidelines.
CAUTION
BEFORE YOU START
Download and install My BP Coach
from iTunes App store or Google play
Apply the Cuff
2.As pictured on the right, position
the cuff on your upper arm.
1.Insert the plug of cuff’s air pipe into
the interface located on the right side
of the monitor.
3.Tighten the cuff. Make sure the cuff
is fixed 2 to 3 centimeters (about an
inch) above your elbow.
You should be able to insert one
finger when the cuff is tightened
around your upper arm.
4.Correct Posture:
It is best to position the cuff on your bare
arm.
Sit comfortably and relaxed in a chair.
The center of the cuff should be about
even with your heart.
Sit with legs relaxed with your feet falling
outwards. Rest your arm on a table with
your palm facing up.
6
AC adaptor
(Included)
1.Battery powered mode:
6VDC 4×AAA batteries
2.AC adaptor powered mode:
6V 1A
(Can be supplied by AC adaptor model
UE08WCP-060100SPA) (Included)
Please unplug the adaptor to use battery
power.
7
CAUTION
In order to get the best effect and protect your monitor, please use the
battery and power adaptor, which complies with U.S. safety standard.
Do not dispose of batteries in fire. Batteries may explode or leak.