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

11
PM-2020-01-07/2020
Unfolded package design of main device and accessories
Main device:

12
PM-2020-01-07/2020
Accessories: Arm Cuff (HEM-RML31)
Accessories: Arm Cuff (HEM-CS24)

13
PM-2020-01-07/2020
List of Harmonized EN Standards
The device is classified as a medical device, Class IIa (MDD Article 9
Annex IX Rule 10)
Applicable Directives: Medical Device Directive (MDD) 93/42/EEC
Radio Equipment Directive 2014/53/EU
RoHS Directive 2011/65/EU
Applicable standards:
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1:2006+Al:2013
EN 60601-1-2:2015
EN 60601-1-11:2015
EN 60601-1-6:201O+A1:2015
EN 60601-2-47:2015
EN 62304:2006+A1:2015
EN 62366-1:2015
EN 80601-2-30:2010+A1:2015
EN ISO 10993-1:2009/AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 13485:2016
EN ISO 14971:2012
EN ISO 15223-1:2016
EN ISO 81060-2:2019+A1:2020
EN 300 328 V2.2.2
EN 301 489-1 V2.2.3
EN 301 489-17 V3.1.1
EN 62479:2010
EN 62368-1:2014+A11:2017
EN 50581:2012
Cleaning of the device
• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral)
detergent to clean your monitor and the arm cuff and then wipe them
with a dry cloth.
• When electrodes are dirty, use a soft cloth or cotton swab moistened
with alcohol-based sanitizer to clean the electrodes.
• Do not use alcohol to clean any other parts, and use it only to clean
electrodes.
• Do not wash or immerse your monitor and arm cuff or other
components in water.
• Do not use gasoline, thinners or similar solvents to clean your monitor
and arm cuff or other components.

14
PM-2020-01-07/2020
Maintenance
To protect your monitor from damage, follow the directions below:
• Changes or modifications not approved by the manufacturer will void
the user warranty.
• DO NOT disassemble or attempt to repair this monitor or other
components. This may cause an inaccurate blood pressure readings
and/or ECG recordings.
Storage
Keep your monitor and other components in the storage case when not
in use.
• Store your monitor and other components in a clean, safe location.
1. Remove the arm cuff from the monitor.
(Pull the air plug in a straight way from the air jack. It clicks during pulling
out).
2. Gently fold the air tube into the arm cuff. Do not bend or crease the air
tube excessively.
3. Place your monitor and other components into the storage case.
Do not store your monitor and other components:
• If the monitor and other components are wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight,
dust or corrosive vapors such as bleach.
• In locations exposed to vibrations or shocks.
Warnings
(Warning indicate a potentially hazardous situation which, if not avoided,
could result in death or serious injury.)
It is important that you read all the warnings and precautions included in
this instruction manual because they are intended to keep you safe,
prevent injury and avoid a situation that could result in damage to the
unit!
• DO NOT use this monitor on infants, toddlers, children or persons who
cannot express themselves.
• DO NOT adjust medication based on readings from this blood pressure
monitor and/or ECG recordings. Take medication as prescribed by your

15
PM-2020-01-07/2020
physician. ONLY a physician is qualified to diagnose and treat high blood
pressure and other heart related conditions.
• DO NOT use this monitor on an injured arm/fingers or an arm/fingers
under medical treatment.
• DO NOT apply the arm cuff on your arm while on an intravenous drip or
blood transfusion.
• DO NOT use this monitor in areas containing high frequency (HF)
surgical equipment, magnetic resonance imaging (MRI) equipment,
computerized tomography (CT) scanners. This may result in incorrect
operation of the monitor and/or cause an inaccurate blood pressure
readings and/or ECG recordings.
• DO NOT use this monitor in oxygen rich environments or near
flammable gas.
• Consult with your physician before using this monitor if you have
common arrhythmias such as atrial or ventricular premature beats or
atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy;
pre-eclampsia or renal disease. NOTE that any of these conditions in
addition to patient motion, trembling, or shivering may affect the blood
pressure readings and/or ECG recordings.
• NEVER diagnose or treat yourself based on your blood pressure
readings and/or ECG recordings. ALWAYS consult with your physician.
• Keep components out of the reach of infants, toddlers and children.
This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers and children.
• DO NOT record an ECG with a cardiac pacemaker, Implantable
Cardioverter Defibrillators, or other implanted electronic devices.
Data Transmission
• This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT
use this product in locations where RF is restricted, such as on an aircraft
or in hospitals. Turn off the Bluetooth® feature in this monitor, remove
batteries when in RF restricted areas.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers and children.
• To help avoid strangulation, keep the air tube away from infants,
toddlers and children.

16
PM-2020-01-07/2020
Cautions
(Cautions indicate a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury to the user or patient or damage to
the equipment or other property.)
• Stop using this monitor and consult with your physician if you
experience skin irritation or discomfort.
• Consult with your physician before using this monitor on an arm where
intravascular access or therapy, or an arterio-venous (A-V) shunt, is
present because of temporary interference to blood flow which could
result in injury.
• Consult with your physician before using this monitor if you have had a
mastectomy.
• Consult with your physician before using this monitor if you have severe
blood flow problems or blood disorders as cuff inflation can cause
bruising.
• DO NOT take blood pressure measurements more often than necessary
because bruising, due to blood flow interference, may occur.
• ONLY inflate the arm cuff when it is applied on your upper arm.
• Remove the arm cuff if it does not start deflating during a blood
pressure measurement.
• When the monitor malfunctions, it may get hot. DO NOT touch the
monitor if it occurs.
• DO NOT use this monitor for any purpose other than measuring blood
pressure and/or recording an ECG.
• During a blood pressure measurement and/or an ECG recording, make
sure that no mobile device or any other electrical device that emits
electromagnetic fields, other than the smartphone to be used with the
monitor, is within 30 cm of this monitor. This may result in incorrect
operation of the monitor and/or cause inaccurate blood pressure
readings and/or ECG recordings.
• DO NOT disassemble or attempt to repair this monitor or other
components. This may cause inaccurate blood pressure readings and/or
ECG recordings.
• DO NOT use in a location where there is moisture or a risk of water
splashing this monitor. This may damage this monitor.
• DO NOT use this monitor in a moving vehicle such as in a car, on an air
craft or during physical activity.

17
PM-2020-01-07/2020
• DO NOT drop or subject this monitor to strong shocks or vibrations.
• DO NOT use or store this monitor in places with high or low humidity,
high or low temperatures or in bright and sunny environments. Refer to
section 14.
• Ensure this monitor is not impairing blood circulation by observing the
arm while blood pressure measurement is occurring.
• DO NOT use this monitor in high-use environments such as medical
clinics or physician offices.
• DO NOT use this monitor with other medical electrical (ME) equipment
simultaneously. This may result in incorrect operation of the devices
and/or cause an inaccurate blood pressure readings and/or ECG
recordings.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and
eating for at least 30 minutes before taking a blood pressure
measurement.
• Rest for at least 5 minutes before taking a blood pressure measurement.
• Remove tight-fitting and thick clothing from your arm while taking a
blood pressure measurement.
• Remain still and DO NOT talk while taking a blood pressure
measurement.
• Remain still while recording an ECG.
• ONLY use the arm cuff on persons whose arm circumference is within
the specified range of the cuff.
• Ensure that this monitor has acclimated to room temperature before
taking a blood pressure measurement and/or recording an ECG. Taking a
blood pressure measurement and/or recording an ECG after an extreme
temperature change could lead to an inaccurate blood pressure readings
and/or ECG recordings. OMRON recommends waiting for approximately
2 hours for the monitor to warm up or cool down when the monitor is
used in an environment within the temperature specified as operating
conditions after it is stored either at the maximum or at the minimum
storage temperature. For additional information of operating and
storage/transport temperature, refer to section 14.
• DO NOT use this monitor after the durable period has ended. Refer to
section 14.
• DO NOT crease the arm cuff or the air tube excessively.

18
PM-2020-01-07/2020
• DO NOT fold or kink the air tube while taking a blood pressure
measurement. This may cause an injury by interrupting blood flow.
• To unplug the air plug, pull on the plastic air plug at the base of the
tube, not the tube itself.
• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs
may result in incorrect blood pressure readings.
• Inflating to a higher pressure than necessary may result in bruising of
the arm where the cuff is applied. NOTE: please refer to section 7 for
taking a blood pressure measurement manually.
• ONLY use the arm cuff, batteries and accessories specified for this
monitor. Use of unsupported arm cuffs and batteries may damage and/or
may be hazardous to this monitor.
• The use of accessories and cables other than those specified or
provided by OMRON could result in increased electromagnetic emission
or decreased electromagnetic immunity of the monitor and result in
improper operation.
• During a blood pressure measurement and/or an ECG recording, the
use of the monitor adjacent to or stacked with another device, other than
the smartphone to be used with the monitor, should be avoided because
it could result in improper operation. In case such use is necessary, the
monitor and the other device should be observed to verify that they are
operating normally.
• OMRON makes no warranty for any data or information that is
collected erroneously by the monitor, or misuse or malfunction as a result
of abuse, accidents, alteration, misuse, neglect, or failure to maintain the
product as instructed.
• Interpretations made by this monitor are potential findings, not a
complete diagnosis of cardiac conditions. All interpretations should be
reviewed by a medical professional for clinical decision-making.
• DO NOT use this monitor in the presence of flammable anesthetics or
drugs.
• DO NOT expose this monitor to strong electromagnetic fields.
• DO NOT use this monitor while charging your smartphone.
• DO NOT record an ECG during cautery and external defibrillation
procedures.
• DO NOT record an ECG in close vicinity to other equipment emitting
acoustic sound.

19
PM-2020-01-07/2020
• DO NOT record an ECG if the electrodes are dirty. Clean them first.
• After ECG analysis, the app may incorrectly identify ventricular flutter,
ventricular bigeminy, and ventricular rigeminy heart conditions as
unreadable. Consult with your physician.
• OMRON does not guarantee that you are not experiencing an
arrhythmia or other health conditions when labeling an ECG as normal.
You should notify your physician for possible changes in your health.
• If the “OMRON connect” app detects possible atrial fibrillation in an
ECG, consult with your physician before making any medical decision,
including altering your use of any drug or treatment.
• The atrial fibrillation detector evaluates for possible atrial fibrillation
ONLY. It will NOT detect other potentially life threatening arrhythmias,
and it is possible that other cardiac arrhythmias may be present.
• The atrial fibrillation detector ONLY evaluates for possible atrial
fibrillation after you have recorded an ECG. It does NOT continuously
monitor your heart and therefore cannot alert you if atrial fibrillation
happens at any other time.
• Result of “Bradycardia” or “Tachycardia” are designations of heart rate,
not a clinical diagnosis of an actual arrhythmia.
Consult with your physician.
• When your fingertips are dry, your ECG recording may not be successful.
If dry, moisten your fingers with a wet towel, a water-based lotion, or
something similar.
• DO NOT record an ECG with dirty hands.
• Make sure to place your smartphone on the smartphone stand of the
monitor when recording an ECG. If it is not placed appropriately on the
smartphone stand, there may be communication issues between the
smartphone and the monitor, and your ECG may not be recorded
successfully.
• The ECG electrodes should not touch any other conductive parts.
• If you wear hearing aids, turn them off.
Data Transmission
• DO NOT replace batteries while your blood pressure readings are being
transferred to your smartphone. This may result in incorrect operation of
this monitor and failure to transfer your blood pressure readings.
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.

20
PM-2020-01-07/2020
• ONLY use 4 “AA” alkaline batteries with this monitor. DO NOT use other
types of batteries. DO NOT use new and used batteries together. DO NOT
use different brands of batteries together.
• Remove batteries if this monitor will not be used for 3 months or more.
• If battery fluid should get in your eyes, immediately rinse with plenty of
clean water. Consult with your physician immediately.
• If battery fluid should get on your skin, wash your skin immediately with
plenty of clean, lukewarm water. If irritation, injury or pain persists,
consult with your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working
condition.
• Make sure the battery compartment is securely closed with the battery
cover when recording an ECG. If the battery cover is not in place,
recording an ECG may not be successful. If you have lost the battery
cover, contact your OMRON retail outlet or distributor.
Disposal
This product should not be disposed of, with other household wastes at
the end of its working life.
To prevent possible harm to the environment or human health from
uncontrolled waste disposal, please separate this product from other
types of wastes and recycle it responsibly to promote the sustainable
reuse of material resources.
Household users should contact either the retailer where they purchased
this product, or their local government office, for details of where and
how they can return this item for environmentally safe recycling.
Transportation and storage conditions
Do not store the device in the following situations:
• If the device is wet.
• Locations exposed to extreme temperatures, humidity, direct
sunlight, dust or corrosive vapors such as bleach.
• Locations exposed to vibrations, shocks or where it will be at an
angle.
Storage and transportation conditions: