Omron HEM-9200T - Blood Pressure Monitor Manual

Introduction

Intended Use
This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with the measurement result.

Please read this instruction manual thoroughly before using the device. Please keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN.

Important Safety Information

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

General Usage

DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician.

Only a physician is qualified to diagnose and treat High Blood Pressure.

This device is not intended to be a diagnostic device.

Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases.

Note that PATIENT motion, trembling, shivering may affect the measurement reading.

Do not use the device on the injured arm or the arm under medical treatment.

Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion.

Consult your physician before using the device on the arm with an arterio-venous (A-V) shunt.

Do not use the device with other medical electrical (ME) equipment simultaneously.

Do not use the device in the area the HF surgical equipment, MRI, or CT scanner exists, or in the oxygen rich environment.

The air tube or the AC adapter cable may cause accidental strangulation in infants.

Contains small parts that may cause a choking hazard if swallowed by infants.

Keep the battery out of reach of children.

Data Transmission

Do not use this product on aircraft or in hospitals. Please remove the battery from the unit. This product emits radio frequencies (RF) in the 2.4 GHz band, use of this product in locations where RF is restricted is not recommended.

The use of RF in this product is licensed for use by the FCC, for further information on any potential restrictions refer to documentation on Bluetooth^® usage by the FCC.

AC Adapter (optional accessory)

Do not use the AC adapter if the device or the power cord is damaged.

Turn off the power and unplug the power cord immediately.

Plug the AC adapter into the appropriate voltage outlet. Do not use in a multi-outlet plug.

Never plug in or unplug the power cord from the electric outlet with wet hands.

Indicates 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.

General Usage

Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.

Consult your physician before using the device for any of the following conditions:

• If you have had a mastectomy.
• People with severe blood flow problems or blood disorders as cuff inflation can cause bruising.

Do not take measurements more than necessary. It may cause bruising due to blood flow interference.

Remove the arm cuff if it does not start deflating during the measurement. Do not use this device on infants or persons who cannot express their intentions.

Do not use the device for any purpose other than measuring blood pressure.

Use only the approved arm cuff for this device. Use of other arm cuffs may result in incorrect measurement results.

Do not use a mobile phone or other devices that emit electromagnetic fields, near the device. This may result in incorrect operation of the device.

Do not disassemble the monitor or arm cuff. This may cause an inaccurate reading.

Do not use in a location with moisture, or a location where water may splash on the device. This may damage the device.

Do not use the device in a moving vehicle (car, airplane).

Read "What to do if your systolic pressure is more than 210 mmHg" of this instruction manual, if your systolic pressure is known to be more than 210 mmHg. Inflating to a higher pressure than necessary may result in bruising where the arm cuff is applied.

AC Adapter (optional accessory)

Fully insert the power plug into the outlet.

When disconnecting the power plug from the outlet, do not pull the power cord. Be sure to pull from the power plug safely.

When handling the power cord, take care not to do the following:
Do not damage.
Do not break it.
Do not tamper with it.
Do not forcibly bend or pull.
Do not twist.
Do not bundle during use.
Do not pinch.
Do not place under heavy objects.

Wipe the dust off from the power plug.

Unplug monitor when not in use.

Disconnect the power plug before cleaning.

Use only an OMRON AC adapter designed for this device. Use of unsupported adapters may damage and/or may be hazardous to the device.

Battery Usage

Do not insert the batteries with their polarities incorrectly aligned.

Use only 4 "AA" alkaline or manganese batteries with this device. Do not use other types of batteries. Do not use new and used batteries together.

Remove the batteries if the device will not be used for three months or more.

General Precautions

• Do not forcibly crease the arm cuff or the air tube excessively.
• Do not press the air tube while taking a measurement.
• To unplug the air plug, pull on the air plug at the connection with the monitor, not the tube itself.
• Do not drop the monitor or subject device to strong shocks or vibrations.
• Do not inflate the arm cuff when it is not wrapped around your arm.
• Do not use the device outside the specified environment. It may cause an inaccurate reading.
• Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

Know Your Device

Contents:
Monitor, arm cuff, 4 "AA" batteries, instruction manual, quick start guide

Monitor:

1. Display
2. START/STOP button
3. Battery compartment
4. Air jack
5. AC adapter jack (for optional AC adapter)

Arm cuff: Arm circumference 9" - 17" (22 - 42 cm)

6. Arm cuff
7. Air plug
8. Air tube

Display:

Display symbols

Irregular Heartbeat Symbol ()
When the monitor detects an irregular rhythm two or more times during the measurement, the irregular heartbeat symbol will appear on the display with the measurement values. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. If the irregular heartbeat symbol displays with your measurement results, we recommend you consult your physician. Follow the directions of your physician.

Movement Error Symbol ()
The movement error symbol is displayed if you move your body during the measurement. Please remove the arm cuff, and wait 2 - 3 minutes. Take another measurement, remain still during measurement.

SYNC Symbol ()
The SYNC symbol () is displayed if device is not connected to Telehealth service receiver or when data is not transmitted successfully. Please see "Connecting failure. Data is not being transmitted." in Troubleshooting section.

Wireless Function

Before use, thoroughly read the instruction manual included with the Telehealth service receiver (in some cases, receiver maybe your smart phone) being used with this blood pressure monitor for instruction about your monitor to Telehealth service receiver, and receiver transmission range. It will be necessary for the blood pressure monitor to be within the receiver's transmission range to successfully transfer data. This Omron blood pressure monitor is designed to connect to specific Bluetooth^® Smart receivers, and is not guaranteed to connect to all Bluetooth^® Smart compatible devices and Telehealth service receiver. "Omron Healthcare, Inc. shall not be liable for loss of use or any other special, incidental, consequential or indirect costs, expenses or damages due to improper usage of this monitor."

Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

1. Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement. Rest for at least 5 minutes before taking the measurement.
2. Stress raises blood pressure. Avoid taking measurements during stressful times.
3. Measurements should be taken in a quiet place.
4. Remove tight-fitting clothing from your arm.

Preparation

Battery Installation

Below procedures are ONLY done at inserting batteries.

1. Put back the battery cover.
   Notes:

• When the depleted battery symbol () appears on the display, turn the monitor off, then replace all batteries at the same time. Long life alkaline batteries are recommended.

4. Connect the device to the Telehealth service receiver.
   As soon as insert batteries, it will automatically start the connection process, as below.
   
   When the display shown above is not appeared, see "Connecting failure." in Troubleshooting section first.
   To retry connecting the Telehealth service receiver, remove batteries and press START/STOP button for 2-3 times. Then start with step 2 again.
   Note: If your Telehealth service receiver asks for PIN code, enter 6 digits of PIN code on the rating label at the bottom of the device to complete.
5. Confirm if the device is successfully connected.
   If the device is connected successfully to the Telehealth service receiver, OK symbol will appear on the display, as below.
   
   When "Err" appears, see "Connecting failure." in Troubleshooting section for more detail.
   

Notes:

• We recommend to keep batteries all the time, even if you chose to use AC adapter.
• If only AC adapter is used without keeping batteries, above device connection process (step 4 and 5) is necessary each time you unplug and plug back the AC adapter.

Using the Device

Applying the Arm Cuff

Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm.

Don't place the arm cuff over thick clothes.

1. Connect cuff plug to the unit.
   
2. Wrap the arm cuff firmly in place around your left upper arm.
   
   
   The bottom edge of the arm cuff should be 1/2 inch (1 to 2 cm) above the elbow. Air tube is on the inside of your arm and aligned with your middle finger.
3. Secure closed with the fabric fastener.
   
   Notes:

• When you take a measurement on the right arm, the air tube will be at the side of your elbow. Be careful not to rest your arm on the air tube.
  

How to Sit Correctly

To take a measurement, you need to be relaxed and comfortably seated, under comfortable room temperature.

• Sit on a chair with your legs uncrossed and your feet flat on the floor.
• Sit upright with your back straight.
• Sit with your back and arm being supported.
• The arm cuff should be placed on your arm at the same level as your heart.

Taking a Measurement

Notes:

• To stop the measurement, press the START/STOP button once to deflate the arm cuff.
• Remain still and do not talk while taking a measurement.
• The memory cannot view on the display.

2. Transferring measured data.
   As soon as the measurement is completed, the data transfer will start automatically, as below.
   
   When the connection symbol () is not appeared, see "Data is not being transmitted." in Troubleshooting section for more detail.
3. After data transfer is completed, press the START/STOP button to turn the monitor off.
   It will automatically turn off after 2 minutes.

Note: Wait 2-3 minutes before taking another measurement. Waiting between measurements allows the arteries to return to the condition prior to taking a measurement.

DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat High Blood Pressure.

This device is not intended to be a diagnostic device.

Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.

Inflating to a higher pressure than necessary may result in bruising where the arm cuff is applied.

Error Messages

Error Display	Cause	Solution
	Irregular heartbeats are detected.	Remove the arm cuff. Wait 2 - 3 minutes and then take another measurement. Repeat the steps in Taking a Measurement section. If this error continues to appear, contact your physician.
	Movement during measurement.	Carefully read and repeat the steps in Taking a Measurement section.
	Connecting failure. Data is not being transmitted.	Refer "Connecting failure. Data is not being transmitted." in Troubleshooting section.
	The batteries are low.	Recommend to replace the batteries with new ones ahead of time. Refer to Preparation section.
	The batteries are depleted.	Replace 4 batteries with new ones at once. Refer to Preparation section.
	Air plug disconnected.	Insert the plug securely. Refer to Applying the Arm Cuff section.
	Arm cuff is applied too loosely.	Apply the arm cuff tighter. Refer to Applying the Arm Cuff section.
	Air is leaking from the arm cuff.	Replace the arm cuff with a new one. Refer to Optional Accessories section.
	Movement during measurement and the arm cuff has not been inflated sufficiently.	Repeat measurement. Remain still and do not talk during measurement. Refer to Taking a Measurement section.
		If "E2" appears repeatedly, inflate the arm cuff manually until it is 30 to 40 mmHg above your previous measurement result. Refer to Taking a Measurement section.
	The arm cuff was inflated exceeding the maximum allowable pressure, and then deflated automatically when inflating the arm cuff manually.	Do not touch the arm cuff and/or bend the air tube while taking a measurement. Do not inflate the arm cuff more than necessary. Refer to Taking a Measurement section.
	Movement during measurement.	Repeat measurement. Remain still and do not talk during measurement. Refer to Taking a Measurement section.
	Clothing is interfering with the arm cuff.	Remove any clothing interfering with the arm cuff. Refer to Applying the Arm Cuff section.
	Device error.	Contact your Telehealth service provider.

Troubleshooting

Problem		Cause and Solution
No power. No display appears on the monitor.		Replace all batteries with new ones. Check the battery installation for proper placement of the battery polarities. Refer to Preparation section.
Measurement values appear too high or too low.		Blood pressure varies constantly. Many factors including stress, time of day, and how you wrap the cuff, may affect your blood pressure. Review the Before Taking a Measurement section and Taking a Measurement section.
Connecting failure. Data is not being transmitted.	The blood pressure monitor might not be properly placed within the receiver's transmission range and is too far from the receiver. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16 ft. (5 m) of the receiver and try again.
	The Bluetooth® feature on the receiver is turned off. Turn the Bluetooth® feature on the receiver ON, and try to transmit the readings again.
	The blood pressure monitor did not pair successfully to the receiver. Try to pair the devices again. Refer to Preparation section.
	The application on the receiver or destination device is not ready. Check the application then try to transmit the readings again. Refer to Preparation section. If the ERR symbol is on the screen after checking the application, contact your Telehealth service provider.

Maintenance and Storage

Maintenance

To protect your device from damage, please follow the directions below:

• Store the device and the components in a clean, safe location.
• Do not use any abrasive or volatile cleaners.
• Do not wash the device and any components by immersing them in water.
• Do not use gasoline, thinners or similar solvents to clean the device.
  
• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean on the monitor and the arm cuff.
• Changes or modification not approved by the manufacturer will void the user warranty. Do not disassemble or attempt to repair the device or components.

Storage

1. Gently fold the air tube into the arm cuff.
   
   Note: Do not bend or crease the air tube excessively.

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.

Optional Accessories

Using the Optional AC Adapter

To disconnect the AC adapter, unplug the AC adapter from the electrical outlet first, and then remove the AC adapter plug from the monitor.

Specifications

Model	HEM-9200T
Display	LCD digital display
Measurement range	Pressure: 0 to 299 mmHg Pulse: 40 to 180 beats / min.
Accuracy	Pressure: ±3 mmHg or 2% of reading Pulse: ± 5% of display reading
Inflation	Fuzzy-logic controlled by electric pump
Deflation	Automatic pressure release valve
Measurement method	Oscillometric method
IP classification	IP 20
Power source	4 "AA" batteries 1.5V or optional AC adapter (INPUT AC100-240V 50/60Hz 0.12A)
Battery life	Approximately 1000 measurements (using new alkaline batteries)
Operating temperature / humidity	50°F to 104°F (10°C to 40°C) / 15 to 90% RH
Storage temperature / humidity / air pressure	-4°F to 140°F (-20°C to 60°C) / 10 to 95% RH / 700 to 1060 hPa
Weight	Monitor : Approximately 10 oz. (290 g) not including batteries Arm cuff: Approximately 6 oz. (170 g)
Dimensions	Monitor : Approximately 4 1/4" (w) × 3 1/8" (h) × 5 1/2" (l) (107 mm × 79 mm × 141 mm) Arm cuff: Approximately 5 3/4" × 23 1/2" (air tube: 29 1/2") (145 mm × 594 mm (air tube: 750 mm))
Cuff circumference	9" to 17" (220 to 420 mm)
Contents	Monitor, arm cuff, 4 "AA" batteries, instruction manual, quick start guide
Applied part	= Type BF
Protection against electric shock	Internally powered ME equipment (When using only the batteries) = Class II ME equipment (Optional AC adapter)

Notes:

• These specifications are subject to change without notice.
• In the clinical validation study, the 5th phase was used on 85 subjects for determination of diastolic blood pressure.
• This device has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by IEC 60529.