OMRON NightView Automatic Wrist Blood Pressure Monitor (HEM-9601T-E3)

Introduction

Thank you for purchasing the NightView. This blood pressure monitor is worn on the wrist and uses the oscillometric method for measurement. It senses pressure pulsations of the artery under the cuff and displays digital readings.

Intended Use

The device is a digital monitor for measuring blood pressure and pulse rate in adults with wrist circumferences from 13.5 cm to 21.5 cm. It detects irregular heartbeats and can activate a "nocturnal measurement" mode for automatic nighttime readings. It is designed for general household use.

Important Safety Information

Read and understand all instructions before use. Consult a physician for personal blood pressure information.

Warning

• Do not use on infants, children, or those unable to express themselves.
• Do not adjust medication based on readings; consult a physician.
• Do not use on injured wrists or wrists with medical devices (SpO2 sensor, IBP catheter, A-V shunt).
• Do not apply cuff during intravenous drip or blood transfusion.
• Avoid use with high-frequency surgical equipment, MRI, CT scanners, hyperbaric oxygen chambers, or in oxygen-rich/flammable gas environments.
• Consult a physician if you have arrhythmias, arterial sclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia, or renal disease, as these can affect readings.
• Never self-diagnose or self-treat.
• Keep away from children (small parts hazard).
• If smoke, strange odors, or sounds occur, stop use immediately.
• Do not use with MRI (risk of fever/burn).
• Avoid environments with vibration, gas, fire, water splash/vapor, or chemical agents.
• If errors occur, check vital signs via auscultation or palpation.
• Management responsibility lies with hospitals/clinics; inspect and maintain regularly.
• Check patient's circulatory status during frequent/long measurements. Apply cuff correctly.
• This product emits RF in the 2.4 GHz band. Do not use in restricted RF areas (aircraft, hospitals). Turn off Bluetooth and remove batteries in such areas.
• Keep batteries out of reach of children.

Caution

• Consult a physician if skin irritation or discomfort occurs.
• Consult a physician before use on wrists with intravascular access/therapy.
• Consult a physician before use if you have had a mastectomy.
• Consult a physician for peripheral circulatory failure, low blood pressure/temperature, artificial heart-lung, A-V fistula, pseudohypertension, convulsion, venous pulse, or body movement (cardiac massage, rheumatism).
• Consult a physician for severe blood flow problems or blood disorders (cuff inflation may cause bruising).
• Do not take measurements more often than necessary to avoid bruising.
• Only inflate the cuff when applied to the wrist.
• Remove the cuff if it does not deflate.
• Use only for blood pressure measurement.
• Keep other electrical devices emitting electromagnetic fields at least 30 cm away.
• Do not disassemble or attempt to repair.
• Avoid moisture or water splashing.
• Do not use in moving vehicles.
• Do not drop or subject to strong shocks/vibrations.
• Avoid high/low humidity or temperature extremes (refer to specifications).
• Observe wrist during measurement for prolonged impairment to circulation.
• Do not use in high-use environments (medical clinics, physician offices).
• Do not use simultaneously with other medical electrical (ME) equipment.
• Avoid bathing, alcohol, caffeine, smoking, exercising, and eating for 30 minutes prior to measurement.
• Rest for at least 5 minutes before measurement.
• Remove tight clothing/accessories from the wrist.
• Remain still and do not talk during measurement.
• Use only on persons with wrist circumference within the specified range.
• Allow monitor to acclimate to room temperature before measurement (approx. 2 hours after extreme temperature changes).
• Do not crease the wrist cuff excessively.
• Do not use after the durable period has ended.
• Use on minors only under direct physician supervision.
• Visually inspect product before use for dirt, wetness, or damage.
• Test device for normal/safe function after long periods of non-use.
• Clean regularly. Do not use alcohol, thinners, or benzine.
• Do not clean with autoclave or gas sterilization.
• Ensure monitor is at heart level and patient is still during measurement.
• Dispose of product according to "Correct Disposal" in section 10.
• Avoid direct sunlight, dust, corrosive vapors, vibration, shocks, or heaters during storage.

1. Know Your Monitor

1.1 Contents

Monitor, 2 "AAA" alkaline batteries, storage case, instruction manual, blood pressure pass.

1.2 Monitor Components

The monitor includes:

• Wrist cuff: Wraps around the wrist.
• Display: Shows readings and symbols.
• Battery compartment: Located on the back/bottom, holds 2 "AAA" batteries.
• Positioning indicator: Aids in correct monitor placement relative to the heart.
• [Date/Time setting] button: For setting date and time.
• [NIGHT] button: Activates nocturnal measurement mode. The indicator light shows status.
• [Connection] button: For Bluetooth pairing and data transfer.
• [Memory] button: To view stored readings.
• [START/STOP] button: To start and stop measurements.

1.3 Display and Symbols

The display shows various information:

• A. Date and time display: Shows current date and time.
• B. Bluetooth ON symbol: Appears when Bluetooth is enabled.
• C. Battery symbol: Flashes when batteries are low; appears when depleted.
• D. Deflation symbol: Appears during cuff deflation.
• E. Sync symbol: Flashes/appears when data needs transferring (memory nearly full).
• F. Irregular heartbeat symbol: Appears with readings if an irregular rhythm is detected.
• G. Movement error symbol: Appears if the body moves during measurement.
• H. Cuff wrap guide symbol: Appears if the cuff is wrapped too loosely.
• I. Systolic blood pressure reading: Displays the systolic value.
• J. Diastolic blood pressure reading: Displays the diastolic value.
• K. Pulse display / Memory number: Shows pulse rate or memory number.

1.4 Classification of BP (Blood Pressure)

Based on 2018 ESH/ESC Guidelines:

*European Society of Hypertension (ESH) and European Society of Cardiology (ESC).

2. Preparation

2.1 Installing Batteries

1. Slide and remove the battery cover using the hook.
2. Insert 2 "AAA" alkaline batteries, observing polarity.
3. Close the battery cover.
The display will flash for 2 minutes upon correct installation.

Note: Replace batteries when the battery symbol flashes. Use new, identical alkaline batteries. Replacing batteries does not delete readings.

2.2 Pairing Your Monitor with a Smart Device

Transfer readings to a smart device via Bluetooth. Date and time are set automatically upon pairing.

1. Enable Bluetooth on your smart device.
2. Download and install the "OMRON connect" app.
3. Open the app, press and hold the [Connection] button on the monitor for over 2 seconds, and follow app instructions.
4. Confirm connection: "OK" appears after flashing 3 times.

Note: OMRON is not responsible for data loss in the app. Use only the "OMRON connect" app.

Check compatible devices at: www.omronconnect.com/devices/

2.3 Setting Date and Time Manually

If not paired with a smart device:

1. Press and hold the [Date/Time setting] button for over 2 seconds. The year flashes.
2. Press the [Memory] button to adjust the year (hold for fast advance).
3. Press [Date/Time setting] to confirm year; month flashes. Repeat for month, day, hour, minute.
4. Press [Date/Time setting] to store.

2.4 Blood Pressure Measurement Tips

For accurate readings:

• Avoid stressful times; measure in a quiet place.
• Take measurements at the same times daily (morning/evening recommended).
• Record readings for your physician; a single measurement is not indicative of true BP.

Precautions before measurement:

• Avoid bathing, alcohol, caffeine, smoking, exercise, and eating for 30 minutes prior.
• Rest for at least 5 minutes.

2.5 Applying the Wrist Cuff

For left wrist (steps are similar for right wrist):

1. Roll up sleeve, ensuring it doesn't constrict blood flow.
2. Place wrist through cuff loop, palm and display facing upward.
3. Position cuff 1-1.5 cm from the wrist bone at the bottom of the palm.
4. Wrap cuff firmly, ensuring no gap. Do not apply over clothing. Ensure cuff does not cover the protruding wrist bone.

Note: OMRON recommends using the same wrist for consistent measurements.

3. Using Your Monitor

3.1 Taking a Measurement in the Morning and Evening

1. Sit with correct posture:

• Relaxed, comfortably seated in a quiet room.
• Elbow on a table for support.
• Legs uncrossed, feet flat on the floor.
• Back and arm supported.
• Monitor at heart level (use positioning indicator).
• Relax wrist and hand; do not bend or clench.

2. Press the [START/STOP] button. All symbols appear briefly.

3. Check the positioning indicator:

• Indicator lights blue when wrist is at correct heart level; orange if too high or low.
• Measurement starts after 5 seconds even if positioning is not optimal.

4. Remain still and do not talk until measurement is complete. The monitor measures during inflation.

Note: If the [Movement error symbol] appears, apply cuff correctly and re-measure.

5. Press the [START/STOP] button to turn off the monitor. It auto-turns off after 2 minutes.

Note: Wait 2-3 minutes between measurements. Replace batteries if the battery symbol flashes.

Transferring Data

Readings transfer automatically via Bluetooth when enabled. Manual transfer is possible via the app and [Connection] button.

3.2 Taking a Measurement automatically while Sleeping (Nocturnal Measurement)

1. With the monitor off, press and hold the [NIGHT] button for over 2 seconds. "ON" appears.

2. Go to bed, maintaining a position that doesn't compromise circulation.

Measurements will automatically start at 2 AM, 4 AM, and 4 hours later.

Note: Nocturnal mode is cancelled if "E1" or "Er" errors occur twice consecutively. It can be manually cancelled by pressing and holding the [NIGHT] button for over 3 seconds when the monitor is off.

4. Using Memory Function

4.1 Viewing the Readings Stored in Memory

1. Press the [Memory] button. The memory number and pulse rate appear.

2. Press the [Memory] button repeatedly to scroll through past readings.

3. Press the [START/STOP] button to turn off the monitor.

Note: If memory is full, oldest readings are deleted. Error symbols from measurements will also appear.

5. Other Settings

5.1 Deleting All Readings Stored in Memory

1. Press [Memory] button to show the latest reading.

2. Hold [Memory] button, then hold [START/STOP] button for over 2 seconds. All readings and pairing information are deleted.

3. Press [START/STOP] to turn off.

5.2 Disabling/Enabling Bluetooth

Warning: Turn off Bluetooth in RF-restricted areas.

1. With monitor off, press and hold [Connection] button for over 10 seconds. "oFF" appears.

2. Press [START/STOP] to turn off.

Note: To enable, press and hold [Connection] for over 2 seconds; "on" appears.

5.3 Disabling/Enabling Positioning Indicator

1. With monitor off, press and hold [Date/Time setting] button for over 5 seconds while holding [Memory] button. "oFF" appears.

2. Press [START/STOP] to turn off.

Note: To enable, repeat steps; "on" appears.

6. Error Messages and Troubleshooting

Check for other electrical devices within 30 cm if problems occur.

7. Maintenance

7.1 General Care

Do not disassemble or attempt repairs. Visually inspect for damage before use.

7.2 Storage

Store in the provided case in a clean, safe location. Avoid wetness, sweat, cosmetics, extreme temperatures, humidity, direct sunlight, dust, corrosive vapors, vibration, or shocks.

7.3 Cleaning

Use a soft dry cloth or a soft cloth moistened with neutral soap, then wipe dry. Do not use abrasive cleaners, volatile cleaners, gasoline, thinners, or immerse in water.

7.4 Calibration and Service

The monitor is tested for accuracy and long service life. Inspection every two years is recommended. Contact an authorized OMRON dealer or Customer Service.

8. Specifications

Note: Specifications subject to change. Clinically investigated per ISO 81060-2:2013. Not validated for pregnant patients. IP classification per IEC 60529. Operating mode per IEC 60601-1.

Wireless Communication Interference: Operates in 2.4 GHz band. Interference may occur near microwave/Wi-Fi. Relocate product or stop other devices if interference occurs. Wireless communication carries risks of third-party interception.

9. Limited Warranty

OMRON warrants this product for 3 years from purchase date against defects in construction, workmanship, and materials. Warranty covers repair or replacement of defective products/parts without charge for labor or parts. It does not cover transport costs, unauthorized repairs, periodic checks, wear of optional parts, costs from claim non-acceptance, accidental/misuse damages, or calibration.

Contact the dealer or an authorized OMRON distributor for warranty service. Visit www.omron-healthcare.com for customer service information.

Warranty does not extend the warranty period. Return the complete product with the original invoice/receipt.

10. Guidance and Manufacturer’s Declaration

Declaration of Conformity

This monitor complies with European Standard EN1060. OMRON HEALTHCARE Co., Ltd. declares compliance with Directive 2014/53/EU. Full text available at: www.omron-healthcare.com.

OMRON products are produced under strict quality systems. Report serious incidents to the manufacturer and competent authority.

Electromagnetic Compatibility (EMC)

HEM-9601T-E3 conforms to EN60601-1-2:2015 EMC standard. Further documentation available at www.omron-healthcare.com.

Symbols Description

• Applied part - Type BF: Indicates the part of the equipment that comes into contact with the patient.
• Degree of protection against electric shock: Refers to protection against leakage current.
• IP XX: Ingress protection degree (e.g., IP22).
• CE Marking: Indicates conformity with EU regulations.
• Serial number, LOT number, Date of manufacture: Identification details.
• Medical Device: Indicates the product is a medical device.
• Temperature limitation, Humidity limitation, Atmospheric pressure limitation: Operating/storage conditions.
• OMRON's trademarked technology: Refers to specific OMRON technology.
• Need for user to consult manual: Indicates important information is in the manual.
• Direct current: Power source type.
• RF Transmitter Indicator: Indicates potential non-ionizing radiation.
• Positioning indicator: Aids correct monitor placement.
• Measurable wrist circumference: Specifies cuff compatibility.

Correct Disposal of This Product

Marking indicates it should not be disposed of with household waste. Separate and recycle responsibly to prevent environmental harm. Contact retailer or local government for details. Business users should check purchase contract terms.

Manufacturer Information

Manufacturer: OMRON HEALTHCARE Co., Ltd., Japan.

EU Representative: OMRON HEALTHCARE EUROPE B.V., The Netherlands.

Production facility: OMRON HEALTHCARE Co., Ltd. Matsusaka Factory, Japan.

Subsidiaries: OMRON HEALTHCARE UK LTD., OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH, OMRON SANTÉ FRANCE SAS.

Issue Date: 2020-02-03

Made in: Japan

Trademarks: Bluetooth® word mark and logos are registered trademarks of Bluetooth SIG, Inc. App Store and Google Play logos are trademarks of Apple Inc. and Google LLC, respectively.