Relion Blood Pressure Monitor BP200 manual

SAFETY INFORMATION

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 readings.

To assure the correct use of the product, basic safety measures should always be followed including the warnings and cautions listed in this instruction manual.

SAFETY SYMBOLS USED IN THIS INSTRUCTION MANUAL
	Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
	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

DO NOT adjust medication based on measurement values from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat High Blood Pressure.
The monitor 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 value.
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 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 of HF surgical equipment, MRI, or CT scanner, or in an oxygen rich environment.
The air tube may cause accidental strangulation in infants.
Contains small parts that may cause a choking hazard if swallowed by infants and small children.
Always consult your physician. Self-diagnosis of measurement values 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 values.
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.
Use only Omron authorized parts and accessories. Parts and accessories not approved for use with the device may damage the unit.
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. For example, the car or airplane.
Read "If your systolic pressure is more than 210 mmHg" in "TAKING A MEASUREMENT" section in this 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 cuff is applied.

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.
If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Contact a physician immediately.

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.

BEFORE TAKING A MEASUREMENT

To ensure a reliable reading follow these recommendations:

1. Avoid eating, drinking alcohol, smoking, exercising, and bathing 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.
5. Sit on a chair with your feet flat on the floor. Rest your arm on table so that the cuff is at the same level as your heart.
6. Remain still and do not talk during the measurement.
7. Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency.

KNOW YOUR UNIT

Main Unit:

Components:

UNIT 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 varies by 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 values, we recommend you consult your physician. Follow the directions of your doctor.

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. Re-apply the arm cuff and take another measurement.

AVERAGE READING SYMBOL

The Average Reading Symbol is displayed when you press and hold the button for more than 3 seconds.

The average reading based on the last 3 measurement values taken within 10 minutes appears on the display screen.

HEARTBEAT SYMBOL

The Heartbeat symbol flashes on the display at every heartbeat during the measurement.

BLOOD PRESSURE LEVEL INDICATOR

If your Systolic Blood Pressure is 135 mmHg or above and/or the Diastolic Blood Pressure is 85 mmHg or above, the High Blood pressure level indicator () will display when the measurement value is displayed. If the measurements are within the standard range, the Normal Blood pressure level indicator () will display.

2013 ESH/ESC Guidelines for the management of arterial hypertension Definitions of hypertension by office and home blood pressure levels

These are from statistical values for blood pressure.

BATTERY INSTALLATION

1. Press the hook on the top of the battery cover and lift the cover off in the direction of the arrow.
2. Install 4 "AA" size batteries so the + (positive) and - (negative) polarities match the polarities of the battery compartment as indicated.
   
   
3. Replace 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.
• Turn the unit off before replacing the batteries. If the batteries are removed while the unit is still on, the date and time will be reset to that of the previous use. The measurement values are not deleted.
• When the batteries are replaced, you may need to reset the date and time. If "-:--" appears on the display, refer to "Setting the Date and Time".
• The batteries included with the device may have a shorter life.

SETTING THE DATE AND TIME

Set the monitor to the correct date and time before taking a measurement for the first time or after replacing the batteries.

1. Press the button to show the year.
2. Push or button to change the year. The year can be set between 2015 and 2045. When the display reaches 2045, it will return to 2015.
3. Push the button to confirm the year and then the month flashes. Repeat the same steps to change the month, day, hour, and minute.
   NOTE: Press and hold or button to increase the date and time values faster.
   
   
4. Press the Start/Stop button to turn the monitor off.

APPLYING THE ARM CUFF

APPLYING THE CUFF ON THE LEFT ARM

1. Make sure the air plug is securely inserted in the main unit.
2. Remove tight-fitting clothing from your upper arm.
   
   
3. Apply the cuff to your left upper arm so the air tube is centered on the inside of your arm and aligned with your middle finger. The air tube runs down the inside of your arm. The bottom of the cuff should be approximately 1/2 inch (1 - 2 cm) above your elbow.
   
   
4. Wrap the cuff firmly in place around your arm using the cloth fastening in the direction of the arrow.
   

APPLYING THE CUFF ON THE RIGHT ARM

When taking a measurement using the right arm, use this instruction for Step 3.

Apply the cuff to your right upper arm so the air tube runs along the inside of your arm. The bottom of the cuff should be approximately 1/2 inch (1 - 2 cm) above your elbow.

NOTES:

• Be careful not to rest your arm on the air tube. This will restrict the flow of air to the cuff.
• 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.

TAKING A MEASUREMENT

The monitor is designed to store the blood pressure and the pulse rate in the memory for two people (USER A or USER B) every time a measurement is completed.

1. Sit on a chair with your feet flat on the floor. Place your arm on a table so the cuff is level with your heart. Remain still and do not talk during measurement.
   
   
2. Select your user ID (A or B).
   
   
3. Press the Start/Stop button. All symbols appear on the display. The cuff starts to inflate automatically. As the cuff inflates, the monitor automatically determines your ideal inflation level. Remain still and do not move your arm until the entire measurement process is completed.
   
   
   If your systolic pressure is more than 210 mmHg
   After the arm cuff starts to inflate, press and hold the Start/Stop button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure.
   NOTE: The monitor will not inflate above 299 mmHg.
   Inflating to a higher pressure than necessary may result in bruising where the arm cuff is applied.
   NOTE: To stop the inflation or measurement, push the Start/Stop button. The monitor will stop inflating, start deflating, and will turn off.
4. Inflation stops automatically and the measurement is started. As the cuff deflates, decreasing numbers appear on the display and the Heartbeat Symbol () flashes.
   
   
5. When the measurement is complete, the arm cuff completely deflates. Your blood pressure and pulse rate are displayed.
6. Remove the arm cuff.
7. Press the Start/Stop button to turn the monitor off.
   
   NOTES:
   • The monitor will automatically turn off after 2 minutes.
   • Wait 2-3 minutes before taking another measurement. Waiting between measurements allows the arteries to return to the condition prior to taking a measurement. You may need to increase the wait time depending on your individual physiological characteristics.

USING THE MEMORY FUNCTION

The monitor automatically stores the results up to 60 sets for each user (A and B). It can also calculate an average value based on the last 3 measurement values taken within 10 minutes.

TO VIEW THE MEASUREMENT VALUES STORED IN MEMORY

1. Select your USER ID (A or B).
2. Press the button to display the set of measurement values. The Memory number appears for a second before the pulse rate is displayed. The most recent reading is numbered "1".
   
   
3. Press the or button to view the values stored in the memory.
   : To view the older values
   : To view the more recent values
   NOTES:
   • If the memory is full, the monitor will delete the oldest value.
   • The date and time are alternately displayed with the measurement values.
   • When viewing the measurement value taken without setting the date and time, "-:--" is displayed instead of the date and time.
   • If there are no measurement values stored in the memory, the screen to the right is displayed.
     
     
4. Press the Start/Stop button to turn the monitor off.

TO VIEW THE AVERAGE READING

1. Select your USER ID (A or B).
2. Press and hold the button for more than 3 seconds.
   NOTES:
   • If the previous measurement was taken without setting the date and time, the average reading is not calculated.
   • If two sets of measurement values are stored in the memory for the 10 minute period, the average is based on the two sets of measurement values. If only one set of measurement values is stored, this is displayed as the average.

TO DELETE ALL VALUES STORED IN THE MEMORY

The values stored in the memory are deleted by USER ID.

You cannot partially delete values stored in the memory. All values for the user you select will be deleted.

1. Select your USER ID (A or B).
2. Press the button to turn the monitor on.
3. When the memory symbol () appears, while pressing and holding the button, press the Start/Stop button for 3 seconds to delete all values in the memory.
   
   
4. Press the Start/Stop button to turn the monitor off.
   NOTE: The monitor will automatically turn off after 2 minutes.

CARE AND MAINTENANCE

To keep your blood pressure monitor in the best condition and protect the unit from damage, follow the directions listed below:

Do not forcefully bend the arm cuff or air tube. Do not fold tightly.

Clean the monitor with a soft dry cloth.

Do not use any abrasive or volatile cleaners. Do not attempt to clean the cuff.

Do not submerge the device or any of the components in water. Do not subject the monitor to extreme hot or cold temperatures, humidity or direct sunlight.

Store the device and the components in a clean, safe location.

Do not subject the monitor to strong shocks, such as dropping the unit on the floor.

Remove the batteries if the unit will not be used for three months or longer. Always replace all the batteries with new ones at the same time. Use the unit in a manner consistent with the instructions provided in this manual.

Use only authorized parts and accessories. Parts and accessories not approved for use with the device may damage the unit.

Changes or modification not approved by the manufacturer will void the user warranty. Do not disassemble or attempt to repair the unit or components.

ERROR INDICATORS

SYMBOL	CAUSE	CORRECTION
	Irregular heartbeats are detected.	Remove the arm cuff. Wait 2-3 minutes and then take another measurement. Repeat the steps in "TAKING A MEASUREMENT". If this error continues to appear, contact your physician.
	Movement during measurement.	Remain still and do not talk during the measurement. Carefully read and repeat the steps in "TAKING A MEASUREMENT".
	Batteries are low.	Recommend to replace the batteries with new ones ahead of time. Refer to "BATTERY INSTALLATION".
	Batteries are depleted.	Replace the four batteries. Refer to "BATTERY INSTALLATION".
	Air plug disconnected.	Insert the plug securely. Refer to "APPLYING THE ARM CUFF".
	Arm cuff not applied correctly.	Apply the arm cuff correctly. Refer to "APPLYING THE ARM CUFF".
	Air is leaking from the arm cuff.	Replace the cuff with a new one.
	Cuff over or under inflated.	Repeat measurement. Remain still and do not talk during measurement. Refer to "TAKING A MEASUREMENT".
		If "E2" appears repeatedly, inflate the cuff manually until it is 30 to 40 mmHg above your previous measurement result. Refer to "TAKING A MEASUREMENT".
	The arm cuff was inflated above 299 mmHg when inflating the cuff manually.	Do not inflate the cuff above 299 mmHg. Refer to "TAKING A MEASUREMENT".
	Movement during measurement.	Repeat measurement. Remain still and do not talk during measurement. Refer to "TAKING A MEASUREMENT".
	Clothing is interfering with the arm cuff.	Remove any clothing interfering with the arm cuff. Refer to "APPLYING THE ARM CUFF".
	Device error.	Contact Customer Service.

TROUBLESHOOTING TIPS

FCC STATEMENT

FCC CAUTION
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

GUIDANCE AND MANUFACTURER'S DECLARATION

ReliOn Blood Pressure Monitor
Information for accompanying documents in the scope of IEC60601-1-2:2007 Model: HEM-741CRELN4

Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC's and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007 standard for both immunity and emissions. Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by ReliOn, with the exception of cables sold by ReliOn as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.
• Refer to further guidance below regarding the EMC environment in which the device should be used.
• The MEDICAL ELECTRICAL EQUIPMENT HEM-741CRELN4 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this documentations.
• The Essential Performance of the HEM-741CRELN4 is to measure a blood pressure and a pulse rate and using the memory function.

The HEM-741CRELN4 may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

Guidance and manufacturer's declaration - electromagnetic immunity
ReliOn™ HEM-741CRELN4 is intended for use in the electromagnetic environment specified below. The customer or the user of this ReliOn™ HEM-741CRELN4 should assure that it is used in such environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3	3 V rms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz	Not Applicable. 3 V/m	Portable and mobile RF communications equipment should be used no closer to any part of the ReliOn™ HEM-741CRELN4 including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance Not Applicable. d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ReliOn™ HEM-741CRELN4 is used exceeds the applicable RF compliance level above, the ReliOn™ HEM-741CRELN4 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ReliOn™ HEM-741CRELN4. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

LIMITED WARRANTY

Your ReliOn™ BP200 Blood Pressure Monitor, Model # HEM-741CRELN4, excluding the arm cuff and batteries, is warranted to be free from defects in materials and workmanship appearing within 5 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The arm cuff is warranted to be free from defects in materials and workmanship appearing within one year from the date of purchase when the monitor is used in accordance with the instructions provided with the monitor. The above warranties extend only to the original retail purchaser.

We will, at our option, replace without charge any monitor or arm cuff covered by the above warranties. Replacement is our only responsibility and your only remedy under the above warranties.

To obtain warranty service contact Customer Service by calling 1-855-776-0662 for the address of Inspection center.

Enclose the Proof of Purchase. Include a letter, with your name, address, phone number, and description of the specific problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit, we recommend insuring the product with return receipt requested.

THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY RELION IN CONNECTION WITH THIS PRODUCT, AND RELION HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY.

RELION SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES.

This warranty provides you with specific legal rights, and you may have other rights which vary from state to state.

Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

FOR CUSTOMER SERVICE
Call toll free: 1-855-776-0662

SPECIFICATIONS

Model:	HEM-741CRELN4 (HEM-8724-WM)
Display:	LCD Digital Display
Measurement Range:	Pressure: 0 to 299 mmHg, Pulse: 40 beats/min to 180 bearts/min.
Accuracy/Calibration:	Pressure: ±3 mmHg or 2% of reading Pulse: ±5% of reading
Inflation:	Fuzzy-logic controlled by electric pump
Deflation:	Automatic pressure release valve
Rapid Air Release:	Automatic exhaust valve
Measurement Method:	Oscillometric method
IP classification:	IP 20
Power Source:	1.5 V 4 "AA" batteries
Battery Life:	Approximately 1000 uses with 4 new alkaline batteries
Operating Temperature/Humidity:	50ºF to 104ºF (10ºC to 40ºC) /15% RH to 90% RH
Storage Temperature /Humidity/Air Pressure:	-4ºF to 140ºF (-20ºC to 60ºC) /10% RH to 95% RH 700 hPa to 1060 hPa
Main Unit Weight:	Approximately 12 3/10 oz. (350 g) not including batteries
Main Unit Dimensions:	Approximately 6"(l) × 4 3/5"(w) × 3 1/2" (h) (150 mm × 118 mm × 90 mm)
Cuff Size:	Approximately 5 3/4" × 23 1/2" (air tube: 29 1/2") (145 mm × 594 mm (air tube: 750 mm))
Cuff Circumference:	Fits arm circumferences 9" to 17" (22 cm to 42 cm)
Memory:	Up to 60 readings per user
Contents:	Main Unit, Wide Range Cuff, 4 "AA" Alkaline Batteries, Instruction Manual, and Quick Start Guide
Optional Accessories:	Arm cuff

=Type BF

NOTE: These specifications are subject to change without notice.