Omron HEM-7530T-E3 Manual

PM-2020-01-07/2020
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
Complete (HEM-7530T-E3)
Versions
Remark
Date
1
Without DoC content
+ key visual
30/09/2020
2
All information added
17/02/2021

2
PM-2020-01-07/2020

3
PM-2020-01-07/2020
Complete
2-in-1 home blood pressure and ECG monitoring
Product Name: Complete (HEM-7530T-E3)
Product Description: Automatic Upper Arm Blood Pressure Monitor +
ECG
Product Category: Electronic Sphygmomanometers with ECG function
Logistic information
Features:
Packaging content:
- ECG Recording
- Monitor
- Blood Pressure Measurement
- Arm Cuff (HEM-RML31-E)
- Afib indicator function
- 4 “AA” alkaline batteries
- Record measurements
- Storage Case
- Intellisense technology
- Instruction Manual
- Cuff Wrap Guide
- Setup Instructions
- Clinically validated
- Blood Pressure Diary
- Omron connect
Package Amount Approximate weight
Approximate dimensions
(wxdxh)
Main Unit 1 550g (w/o batteries) 232 mm x 123 mm x 98 mm
Single Package 1
1630 g
140 mm x 160 mm x 246 mm
Master Carton 6
10.7 kg
511 mm x 306 mm x 287 mm
UDI-ID (Unique
Device Identifier) /
EAN code
Storage & transport
Temperature: - 20 to +60°C
Humidity: 10% to 90%

4
PM-2020-01-07/2020
Technical data
Product category
Electronic Sphygmomanometers with ECG
function
Product description
Automatic Upper Arm Blood Pressure
Monitor
Single lead electrocardiogram
Model (code)
Complete (HEM-7530T-E3)
BP reading display
LCD digital display
Operation mode
Continuous operation
IP classification
IP 21
Rating
DC6 V 4 W
Power source
4 “AA” alkaline batteries 1.5 V
Battery life
Approximately 300 measurements (using
new alkaline batteries)
Durable period / Service life
Monitor: 5 years
Cuff: 5 years
Operating conditions
+10 °C to +40 °C / 15 to 90 % RH (non-
condensing) / 800 to 1060 hPa
Storage / Transport
conditions
-20 °C to +60 °C / 10 to 90 % RH (non-
condensing)
Weight
Monitor: Approximately 550 g not
including batteries
Arm cuff: Approximately 170 g
Dimensions
Monitor: Approximately 232 mm (w) × 98
mm (h) × 123 mm (l)
Arm cuff: Approximately 145 mm
× 594
mm (air tube: 750 mm)
Applied part
Type BF (arm cuff), Type CF (electrodes)
Protection against electric
shock
Internally powered ME equipment
Maximum temperature of
the applied part
Lower than +48 °C
Contents
Monitor, arm cuff (HEM-RML31), storage case,
4 “AA” alkaline batteries, instruction manual,
setup instructions, blood pressure diary

5
PM-2020-01-07/2020
Blood pressure measurement:
Cuff pressure range
0 to 299 mmHg
Blood pressure measurement
range
SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
Pulse measurement range
40 to 180 beats / min.
Accuracy
Pressure: ±3 mmHg
Pulse: ± 5 % of display reading
Inflation
Automatic by electric pump
Deflation
Automatic pressure release valve
Measurement method
Oscillometric method
Transmission method
Bluetooth® Low Energy
Wireless communication
Frequency range: 2.4 GHz (2400 - 2483.5
M
Hz)
Modulation: GFSK
Effective radiated power: <20 dBm
Cuff circumference
applicable to the monitor
17 to 42 cm (included arm cuff: 22 to 42
cm)
Internal memory
Stores up to 90 blood pressure readings
ECG recording:
Performance characteristics
ECG channel: Single channel
Input dynamic range: 10 mV Peak-to-Peak
Circuitry
Frequency response: 0.67 Hz to 40 Hz
CMRR: > 60 dB
Input Impedance: > 10 MΩ
Output
Modulation: Frequency modulated
ultrasonic audio tone
Cen
ter frequency: 19 kHz
Modulation index: 200 Hz/mV
Accuracy of Afib algorithm
98% sensitivity and 97% specificity1
1.
Lau JK, Lowres N, Neubeck L, Brieger
DB, Sy RW, Galloway CD, et al. Int J
Cardiol.
2013;165(1):193-4

6
PM-2020-01-07/2020
General description
Thank you for purchasing the OMRON Complete Automatic Upper Arm
Blood Pressure Monitor + ECG.
This monitor has 2 main features: a blood pressure measurement and an
electrocardiogram (ECG or EKG) recording.
There are 3 ways to use this monitor: measuring blood pressure only; ECG
only; blood pressure and ECG simultaneously.
Visit the “Help” section in the “OMRON connect” app for additional
information about using the app.
Packaging content
The manufacturer produces Complete with the applicable accessories
included, necessary for the application of its intended purpose.
1. Monitor
2. Arm cuff (HEM-RML31)
3. 4 “AA” batteries
4. Storage case
5. Instruction Manual
6. Setup instructions
7. Blood pressure diary
The complete set of the medical device is specified in the Instruction
Manual / Specifications section.
Purpose
The device is intended to measure blood pressure only,
electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult population.
The device is intended to record, store, and transfer single-channel
electrocardiogram (ECG) rhythms.
The device in combination with a smartphone, displays ECG rhythms and
detects the presence of atrial fibrillation, bradycarda, tachycardia and
normal sinus rhythm.
.

7
PM-2020-01-07/2020
Application field
It is designed for general household use.
Intended User
The device is intended for use by healthcare professionals, patients with
known or suspected heart conditions, and health-conscious individuals in
a general household situation. The device has not been tested and it is
not intended for pediatric use.
Indications for use
The device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult population. The device is intended to
record, store, and transfer single-channel electrocardiogram (ECG)
rhythms.
Features (Particularities)
The Complete Automatic Upper Arm Blood Pressure Monitor and Single
Lead Electrocardiogram is a clinically validated device.
Key features:
Description of operating principle
The device operates on the oscillometric principle. It detects blood
movement through the brachial artery and converts the movements into
a digital reading.
- ECG Recording
- Blood Pressure Measurement
- Afib indicator function
- Record measurements
- Omron connect
- Intellisense technology
- Cuff Wrap Guide
- Clinically validated

8
PM-2020-01-07/2020
The device in combination with a smartphone, displays ECG rhythms and
detects the presence of atrial fibrillation, bradycarda, tachycardia and
normal sinus rhythm.
How to use the device
Main steps:
Preparations:
1. Prepare for a measurement. 30 mins before it you shouldn’t drink
alcohol, smoke, have a hot shower, consume hot beverages, eat or
exercise. 5 minutes before the measurement relax and rest.
2. Download and install the “OMRON connect” App
3. Install the batteries.
4. Pair your monitor with your smartphone. When the monitor is
successfully connected, the OK symbol flashes. Bluetooth must be
enabled!
5. Set the date and time.
Taking a Blood Pressure measurement and Recording an ECG:
6. Apply the arm cuff on the left arm. (If using the right arm instead,
consult Chapter 3.3.3 of the IM). Attach the arm cuff to the monitor.
7. Sit correctly and place your arm at your heart’s level. Remain still
and don’t talk.
8. Open the OMRON connect app on your smartphone
9. Follow the instructions to start an ECG recording on your
smartphone and place the phone on the smartphone stand of your
monitor
10. Press the BP (START/STOP) button to take a blood pressure
measurement
11. Put your thumbs on the top electrodes and 2 or more fingers on
each of the side electrodes. Once all 4 electrodes are covered, the
ECG recording will automatically start
12. Remain still and don’t talk until the measurement and recording
process is over
Blood Pressure Measurement: the blood pressure and pulse rate are first
displayed on the monitor, then the readings transfer to your phone.
ECG Recording: The app starts a 30-second countdown and shows the ECG
wave on your smartphone. After completion of the recording, an
ECG analysis result appears. It may show: Possible Afib, Bradycardia,

9
PM-2020-01-07/2020
Tachycardia, Normal, Unreadable, Unclassified or other messages.
The blood pressure reading will also appear on the phone screen.
13. Release the electrodes and remove the arm cuff.
14. Press the BP (START/STOP) button to turn the monitor off.
Please, review the Instruction Manual for the full details on the
application of this product.
Optional medical accessories
Product Description
Model
Upper Arm Blood Pressure Monitor Cuff
HEM-RML31
Upper Arm Blood Pressure Monitor Cuff
HEM-CS24
Materials used in main device
Item Parts Material
Package
Package
Coated board + E/F
Soft case
PU (polyurethane)
Instruction manual
Wood free paper
Setup instructions
Wood free paper
BP Diary
Wood free paper
Main
unit
Front housing
ABS (acrylonitrile butadiene
styrene)
Ground housing
ABS
Power switch
ABS
Communication switch
ABS
LCD panel
PC (Polycarbonate)
Rubber plate
TPU (thermoplastic
polyurethane)
Electrode plate
SUS304
Earth electrode
SUS304
Battery cover
ABS
Rubber foot
PU
Air connector cap
ABS

10
PM-2020-01-07/2020
Materials for accessories
Item Parts Material
Cuff
HEM-
RML31*
Air plug
ABS
Inner cloth
Polyester / PVC
Outer cloth
Nylon / PVC
Tube
PVC (polyvinyl chloride)
Bias
Polyester
/
Cotton
Hook Fastener
Polyester
Nipple
PVC
Ring
Steel
Cuff
HEM-
CS24
Air plug
ABS
Inner cloth
Polyester / PVC
Outer cloth
Nylon / PVC
Tube
PVC
Bias
Polyester
/
Cotton
Hook Fastner
Polyester
Nipple
PVC
Ring
Steel
*Cuff provided with the main device
Title page of the Instruction Manual