Omron HEM-9210T User Manual

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9. Guidance and Manufacturer’s Declaration
OMRON Blood Pressure Monitor (BPM) including AC-adapter
Information for accompanying documents in the scope of IEC60601-1-2:2014
Table 1 - EMISSION Limits and Compliance
Important information regarding Electro Magnetic Compatibility (EMC)
This device manufactured by OMRON HEALTHCARE Co., Ltd. conforms to
IEC60601-1-2:2014 Electro Magnetic Compatibility (EMC) standard.Nevertheless, special
precautions need to be observed:
• 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
device and result in improper operation.
• During measurement, the use of the device adjacent to or stacked with other device should
be avoided because it could result in improper operation. In case such use is necessary, the
device and other device should be observed to verify that they are operating normally.
• During measurement, Portable RF communications device (including peripherals such as
antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to
any part of the device, including cables specified by OMRON. Otherwise, degradation of the
performance of the device could result.
• Refer to further guidance below regarding the EMC environment in which the device should
be used.
Phenomenon EMISSION Limits Compliance
Conducted and radiated
RFEMISSIONS
CISPR 11 Group1, Class B
Voltage fluctuations and
flicker
See IEC 61000-3-3 Complies

Omron HEM-9210T Specifications

General

Device Type	Upper Arm Blood Pressure Monitor
Type	Digital
Measurement Method	Oscillometric
Measurement Range Pressure	0 to 299 mmHg
Cuff Size	22-42 cm
Irregular Heartbeat Detection	Yes
Cuff Wrapping Guide	Yes
Body Movement Detection	Yes
Average Reading Function	Yes
Clinically Validated	Yes
Display	LCD
Automatic Shut-off	Yes
Cuff Fit Detection	Yes
Connectivity	Bluetooth
Measurement Range Pulse	40 to 180 beats/min
Technology	IntelliSense
Power Source	4 x AA batteries or AC adapter

Summary

Important Safety Information

General Usage

Details precautions for medication, pre-existing conditions, and general use.

General Usage Precautions

Emphasizes consulting a physician, avoiding self-treatment, and specific conditions like mastectomy.

General Precautions

Covers cuff handling, device handling, environment, and disposal.

Know Your Device

Detailed Display Symbols

Irregular Heartbeat Symbol

Explains the symbol for irregular heartbeat detection and when to consult a physician.

Movement Error Symbol

SYNC Symbol

Wireless Functionality

Preparation for Measurement

Provides essential steps and advice to follow before taking a blood pressure measurement.

Device Preparation

Battery Installation

Details the process of removing, inserting, and replacing the battery cover.

Device Connection Process

Describes the automatic connection process to the Telehealth service receiver after battery insertion.

Confirming Successful Connection

Using the Device

Applying the Arm Cuff

Instructions on preparing the arm and connecting the air plug to the unit.

Arm Cuff Placement

Details how to wrap the arm cuff firmly and its correct positioning relative to the elbow.

Securing the Arm Cuff

Instructions on securely closing the cuff with the fabric fastener and notes on arm selection.

Correct Sitting Posture

Guides on how to sit correctly for a relaxed and comfortable measurement.

Taking a Measurement

Provides notes on stopping measurement, remaining still, and data storage.

Measurement Procedure

Details the process of pressing START/STOP, inflation, deflation, and completion.

High Systolic Pressure Procedure

Explains how to adjust inflation for readings above 210 mmHg to avoid bruising.

Data Transfer

Describes the automatic transfer of readings after measurement and how to troubleshoot if it fails.

Error Messages and Troubleshooting

Error Messages

Details common error displays, their causes, and corresponding solutions.

Additional Error Messages

Lists more error codes (E1, E2, E3) with their causes and solutions.

Further Error Messages

Details error codes (E4, E5, Er) and their causes/solutions, including communication failures.

General Troubleshooting

Addresses common problems like 'No power' and 'Measurement values too high or too low'.

Troubleshooting Connection Failure

Provides solutions for 'Connection failure. / Data is not being transmitted.' issues.

Maintenance and Storage

Device Maintenance

Specifications

Measurement and Transmission Methods

Wireless and Power Specifications

FCC/IC/RE Statements and Trademarks

Limited Warranty