Ozeri CardioTech BP6T Blood Pressure Monitor User Manual

Ozeri CardioTech BP6T Blood Pressure Monitor User Manual

INTRODUCTION

Thank you for purchasing the Ozeri BP6T Fully Automatic Blood Pressure Monitor. This device uses the oscillometric method of blood pressure measurement which detects th movement of blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because no stethoscope is needed while using an oscillometric monitor. This device automatically stores 399 sets of 3 measurement values with date and time data for 3 users (1197 measurements total). You can access the stored data simply by pressing the MEM button.

The BP6T Monitor includes the following items:

• Monitor
• Cuff
• Instruction manual printed in English
• Carrying bag
• Built-in rechargeable batter

Safety Information
The following explains the symbols found on this device’s rating label and other locations:

| Symbol for “THE OPERATION GUIDE MUST BE READ”| | Type B applied part symbol (USA)Type BF applied part symbol (UK)
---|---|---|---
 |  Symbol for “MANUFACTURER”|  | Symbol for “DISPOSAL: Do not dispose in trash. Follow local laws for proper disposal and recycling.”
| Symbol for “SERIAL NUMBER”| __| Symbol for “Direct current”
 | Symbol for “MANUFACTURE DATE”|   | Symbol for “ Class II Equipm ent”

IMPORTANT SAFETY INFORMATION

To ensure the correct use of this product, basic safety measures should always be followed. Read all information in the instruction manual and any other literature included in the box before using this device, and observe all Warnings and Cautions.

Warnings
The following are warnings of potentially hazardous situations which, if not avoided, could result in death or serious injury:

• DO NOT confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Contact your physician for specific information about your blood pressure. Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician or licensed healthcare provider.
• Consult your physician before measuring blood pressure, especially if you have any of the following conditions: Hypertension, Diabetes, Arteriosclerosis, Kidney or Vascular Disease, or any conditions affecting circulation.
• 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.
• The monitor is not intended to be a diagnostic device, for indoor use only.

IMPORTANT SAFETY INFORMATION (CONTINUATION

• This device is intended for use in measuring blood pressure and heart rates for adults only. Do not use on infants or persons who cannot express their intentions.
• Do not use this device if pregnant. This device is contraindicated in women who are or may be pregnant. Consult a physician instead.
• This unit is not suitable for continuous monitoring during medical emergencies or operations.
• The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Contact a physician immediately.

Precautions
The following are Precautions of potentially hazardous situations which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property:

• Read all of the information in the instruction manual and any other literature in the box before operating the unit.
• Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.
• Use only Ozeri authorized parts and accessories. Parts and accessories not approved for use with the device may damage the unit.
• Operate this device only as it is intended. Do not use this device for any other purpose.
• Do not use a cellular phone near this device. Cell phones may inhibit the accuracy of this device.
• Do not disassemble or attempt to repair this device or any of its components. Doing so will void the warranty.
• Do not use this device where flammable gases (such as anesthetic gas, oxygen or hydrogen) or flammable liquids(such as alcohol) are present.
• This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than for functions other than obtaining a blood pressure measurement.
• If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure.
• If the cuff pressure exceeds 40 kPa (300 mmHg),the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the wrist and press the stop button to stop inflation

HEALTH AND BLOOD PRESSURE VALUES

What is the standard blood pressure classification? This device refers to a blood pressure classification published by the American Heart Association (AHA).

The American Heart Association guidelines for the upper limit of Normal Blood Pressure are 135 mmHg for Systolic and 85 mmHg for Diastolic.

This chart reflects blood pressure categories defined by American Heart Association.

Grade on the blood pressure monitor| Blood Pressure Category| SystolicmmHg (upper#)| | Diastolic mmHg (lower#)
Green – One Bar| Normal| less than 120| and| less than 80
Green – Two Bars| Prehypertension| 120-139| or| 80-89
Yellow – Three Bars| High Blood Pressure (Hypertension) Stage 1| 140-159| or| 90-99
Orange – Four Bars| High Blood Pressure (Hypertension) Stage 2| 160 or higher| or| 100 or higher
Red – Five Bars| Hypertensive Crisis (Emergency care needed)| Higher than 180| or| Higher than 110

The following is a 1999 blood pressure classification chart published by the World Health Organization (WHO) and  International Society of Hypertension (ISH):

UGGESTIONS BEFORE MEASURING

CAUTION
Only a physician can tell you your normal blood pressure range and the point at which you are at risk. If the measurements taken with this product consistently fall outside your normal range, consult your physician for further testing

1. Rest for at least 5-10 minutes before taking your blood pressure.
2. Avoid eating, smoking, exercising, bathing and drinking (especially alcohol, caffeine or tea) for at least 20-30 minutes before taking a measurement, and avoid talking while measuring your blood pressure.
3. Make sure the wrist cuff is at heart level.
4. Stress raises blood pressure. Try to keep calm before and during the measurement process.
5. Avoid a very cold environment.
6. Use the bathroom before taking measurement.
7.  Avoid excessive talking and hand movement.
8. Wait at least 20 min after taking bath or shower.
9. Wait 2-3 minutes before retaking your blood pressure measurement.
10. ep the records for your physician and refer to your physician for guidance. Remember that one reading does not provide a true blood pressure value; only long-term records will reveal a more accurate picture of your blood pressure. Try to take your measurement at the same time each day to stay consistent

LCD FULL DISPLAY

contraction
| DiastolicBlood Pressure| Lower blood pressure produced by heart’s relaxation
| Pulse| Beats per minute
| Low Battery| Low battery and please charge the power.
**| Unit| Measurement unit of blood pressure
| IHB Detector| Irregular Heartbeat Detector
I| Grade| Blood pressure classifications according to the American Heart Association
| Memory| Displays measurements stored in memory
| Time| Hour:Minute (Month/Day/Year)
**| Heartbeat| Heartbeat detection during the measurement
| User 1| Start measurement and save the results for User 1
| **** User 2| Start measurement and save the results for User 2
| User 3| Start measurement and save the results for User 3

SUGGESTIONS BEFORE MEASURING

Included:

1. Blood Pressure Monitor (BP6T)
2. User Manual
3. Storage Pouch
4. USB Cable and AC Adaptor
   (INPUT: 100-240VAC 50/60Hz 0.3A Max
   OUTPUT: 5V 1000mA)

CHARGING YOUR DEVICE

1. The BP6T blood pressure monitor uses a built-in rechargeable lithium-ion battery, with a capacity of 420 mAh.
2. Please use the AC adaptor and USB cable to charge he battery, as illustrated in the following picture
   AC adaptor
   

Charge the device when any of the following occu

• +LO displays on the LCD.
• The LCD display is dim.
• When the LCD fails to light up.

CAUTION

1. The battery of the BP6T has a built-in rechargeable lithium-ion battery. Please do not disassemble. Only an authorized technician may replace it.

2. The unit may recharge up to 300 times under normal usage. If the battery does not charge and the blood pressure monitor cannot be used normally, please contact an authorized technician. With a full charge the unit can be used to measured three times a day for about 25 days.

3. Store the blood pressure monitor in a cool and dry place, and avoid storing near a heat source as it may cause the battery to explode.

4. Only use the included AC Adapter to charge the unit. You will not be able to use the blood pressure monitor while it is charging.

5. During the process of charging, the blood pressure monitor will display the charging icon shown at right. When charging is finished please unplug before using.

6. Do not use this device while it is charging.

PROGRAMMING THE UNIT

Setting Time Format, Time, Date and Measurement Unit

It is important to set the date and time before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory.

1. With the unit off, press and hold “SET” button for 3 seconds to enter Time Setting Mode. The time format will blink first. Press “MEM” button to change the time format between 12H and 24H.
   

2. Press ‘SET’ to confirm your selection [HOUR FORMAT]. The HOUR setting will then blink for programming

3. Press “MEM” to advance in increments of one

4. Press “SET” to confirm the [HOUR]. The proceed to program the [MINUTE

5. Repeat Step 3 and 4 to confirm the [MINUTE]

6. Repeat Step 3 and 4 to confirm [MONTH], [DAY] and [YEAR].
   .

7. Repeat Step 3 and 4 to confirm the [UNIT].
   

8. After the unit has been set it will display the picture at right and then turn off automatically
   

APPLYING THE CUFF AND POSITIONING

Correct Measurement Position
In order to get an accurate reading, sit upright in a chair and rest your left elbow on the table. If needed use a cushion, pillow or your other wrist for support. Keep your palm facing up and make sure the monitor is at heart level. Take a few deep breaths and relax your body, especially between your elbow and fingers.

Your fingers should be relaxed and in a natural resting position:|

Wrist should also be relaxed and in a natural resting position:

MEASURING YOUR BLOOD PRESSURE

Starting a Measurement

1. After correctly positioning the cuff, press the START/STOP button to turn on the device. The user icon will blink. Press “MEM” to select either User 1, 2 or 3.

2. When the desired User ID blinks, press the START/STOP button again to confirm the User ID. The device will then display 0 on the LCD, and initiate a measurement for the selected user.
   Initial LCD Display
   Measurement begins at 0

Inflation and measurement begin automatically

Final measurement displayed on screen and saved into memory

Grade on the blood pressure monitor| Blood Pressure Category| SystolicmmHg (upper#)| | Diastolic mmHg (lower#)
---|---|---|---|---
Green – One Bar| Normal| less than 120| and| less than 80
Green – Two Bars| Prehypertension| 120-139| or| 80-89
Yellow – Three Bars| High Blood Pressure (Hypertension) Stage 1| 140-159| or| 90-99
Orange – Four Bars| High Blood Pressure (Hypertension) Stage 2| 160 or higher| or| 100 or higher
Red – Five Bars| Hypertensive Crisis (Emergency care needed)| Higher than 180| or| Higher than 110

• Red
• Orange
• Yellow
• Green

3. Press the START/STOP button to turn off the device. The device will also turn off automatically after 1 minute of inactivity.

Important Instructions:

• Ensure that you are not eating, talking, laughing or smoking for at least 5 minutes before a measurement.
• Do not talk, read, eat or watch television during measurement. Try your best to relax and avoid distractions.
• Stimulants such as caffeine and certain medicines can affect your blood pressure. Taking your blood pressure at the same time every day in a relaxed setting will provide a better picture of your blood pressure over time.
• Using your blood pressure monitor’s Average function is recommended as individual results may vary based on other factors, such as stress, exercise, smoking, ambient temperature, and a recent meal resulting in a full stomach  and/or bladder.
• Taking your blood pressure at home and then at your Doctor’s office can sometimes lead to different results, due to heightened anxiety sometimes experienced when visiting the Doctor.
• Ensure that your arm/wrist and heart are level.
• Taking repeated readings in rapid fashion can lead to inaccurate measurements. Allow for a few minutes to pass before the next reading, taking care to remain relaxed and calm.
• Always sit upright while taking a measurement and rest your elbow on a flat surface. Do not cross your legs.
• Ensure that thick clothing is removed when taking a measurement.
• Ensure that the wrist cuff is ¼” to ½” away from the bottom of your palm.
• Ensure that the wrist cuff is fitted so as to allow one finger to fit in between your wrist and the cuff.
• Do not place cellular phones near the blood pressure monitor.

CAUTION

1. . When using this device, please pay attention to the following situations which may interrupt blood flow and influence blood circulation, potentially causing harm or injury to the user of this device.
   • Too frequent and consecutive multiple measurements.
   • The application of the cuff and it pressurization on any wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the wrist on the side of  a mastectomy.
2. Do not apply the cuff over a wound, otherwise it can cause further injury.
3. Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT.
4. Excessive use that results in prolonged impairment of the circulation of the blood of the PATIENT.
5. Don’t kink the connection tube, otherwise,the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT;
6. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s wrist and fingers may become numb, swollen, and even purple due to a lack of blood.

ABOUT BLOOD CIRCULATION AND PRESSURE

Blood circulation is responsible for supplying the body with oxygen from the lungs. During each heartbeat cycle, the blood pressure exerted on the arteries varies between a maximum (systolic) and a minimum (diastolic) pressure.

The systolic blood pressure value (higher pressure or top value) represents the blood pressure produced by the heart muscle when it contracts and pumps the blood out of the heart.

The diastolic blood pressure value (lower pressure or lower value) represents the blood pressure produced in between heartbeats when the heart muscle relaxes.

Systolic Blood Pressure

Diastolic Blood Pressure

IRREGULAR HEARTBEAT?

An irregular heartbeat is defined as a heartbeat that varies by 25% from the average of all heartbeat intervals while the unit is measuring the systolic and diastolic blood pressure.

Normal Heartbeat

Irregular Heartbeat

This Blood Pressure Monitor is equipped with an intelligent Irregular Heartbeat (IHB) Detector. During each measurement, the monitor records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15, this device will record an IHB.

If an irregular rhythm is detected more than twice during measurement, the irregular heartbeat symbol with three hearts will appear on the display along with the measurement results

Note: The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. Do not use this device as a substitute for proper medical diagnosis and check-ups by your physician.

WHAT IS ARRHYTHMIA?

A heartbeat is stimulated by electrical signals that cause the heart to contract. Arrhythmia is a condition where the heartbeat rhythm is abnormal due to flaws in the bio-electrical system that drives the heartbeat. Typical symptoms are skipped heartbeats, premature contraction, an abnormally rapid (tachycardia) or slow (bradycardia) pulse. This can be caused by heart disease, aging, physical predisposition, stress, lack of sleep, fatigue etc. The appearance of an irregular heartbeat symbol does indicate arrhythmia. Arrhythmia and other heart conditions can only be properly diagnosed by a doctor through a medical examination.

RECALLING RECORDS

Recalling Records in Memory

1. When the monitor is off, press “MEM” button to access the memory. The LCD will display the average value of the most recent readings first
   

2. Press “MEM/UP” button or “SET/DOWN” button to scroll up or down through the records. Press the “MEM” button to sort the records from the most recent to the oldest. Press the “SET” button to sort the records from the oldest to the most recent. Alternatively, press and hold the “SET” button to skip through the memory in increments of 10, as in M01, M11, M21, M31, etc. Press and hold “SET” button to review the records as M01, M11, M21, M31…, etc
   

3. To view another user’s records, first ensure that the device is in memory mode. With the device in memory mode, press the START/STOP button to turn it off. Then press the START/STOP button again to turn it on. The user icon will blink on the LCD. Press the “MEM” button to select the desired user ID, then press “SET” to confirm. The device will turn off. Pressing the “MEM” button next will activate the device in memory mode for the selected user ID.

DELETING RECORDS

CAUTION

This device features enhanced memory to store up to 399 records for 3 different users. The most recent reading is by default shown first, following by the next most recent reading. Once the memory is full, i.e. upon taking the 400th measurement, this device will automatically delete the 1st record from memory.

Delete the Records

1. To delete a single or all records from memory for a given user, first ensure the device is in memory mode for the intended user. The press and hold the “MEM” button for 3 seconds. The device will then display “ALL DEL” in the center of the screen, and the user number on the bottom left of the screen. Press “SET” to delete all records.

2. Alternatively, press “MEM” again and the device will display “ONE DEL” in the center of the screen, and the user number on the bottom left of the screen. Press “SET” to delete the single record.

Note, to exit out of delete mode without deleting any records, press the START/STOP button before pressing “SET” to confirm any delete commands.

3. The device will display “DEL DONE” on the screen to confirm the deletion command was completed.

4. If the device has no records in memory, the LCD will display dashes on the screen as shown at right when pressing “MEM” to enter memory mode.

TROUBLESHOOTING THE UNI

The following table includes a list of error messages and the possible causes and solutions for problems you may encounter with your blood pressure monitor. If the product is not operating as you think it should, please check here before arranging for servicing.

Charge the device.
Low battery charge| Low battery charge symbol on screen| Battery charge is too low.| Charge the device.

Error massage

| E 1| The cuff is not secured properly.| Refasten the cuffand then measure again.
E 2| The cuff over inflated.| Refasten the cuff and then measure again.
E 3| The cuff is too tight due to over-inflation.| Relax for a momentand then measure again.
E 10 or E 11| The monitor detected motion while measuring.| Movement can affect the measurement. Relax for a moment and then measure again.
E 20| The monitor did not detect a pulse signal.| Refasten the cuff, taking care not to overtighten. Then measure again.
E 21| Measurement error.| Relax for a moment and then measure again.
Eexx| A calibration error occurred.| Relax and retake the measurement. If the problem persists, contact support@ozeri.com for further assistance. Refer to the warranty for contact information and return instructions.

MAINTENANCE

In order to get the best performance and to maximize the life of your unit please review the following tips:

Store in a dry cool place and avoid direct sunshine.

Only use a clean dry cloth to wipe the unit. Do not use a damp or wet cloth. Do not expose any part of this device to water

Do not drop or shake the unit, and do not store objects on the unit.

Avoid dusty and unstable temperature environments

SPECIFICATIONS

Power supply| 3.7V 420mAH Built-in rechargeable lithium-ionbattery, 5V / 1A USB AC Adaptor
---|---
Display mode| Digital LCD V.A.46.5 x 36.5mm
Measurement mode| Oscillographic testing mode
**Measurement range| Rated cuff pressure:0kpa-40kpa (0mmHg – 300 mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg – 230mmHg)pulse value: (40-199) beat/minute
Accuracy| Pressure:5℃ – 40℃ within ±0.4kpa (3mmHg) pulse value: ±5%
Normal working condition| Temperature: 5℃to 40℃ Relative humidity ≤85%Atmospheric pressure: 86kPa to 106kPa
Storage & transportation condition| Temperature: -20℃ to 60℃ RH: 10% to 93% Atmospheric pressure: 50kPa to 106kPa
Measurement perimeter of the wrist| ** About 13.5cm – 21.5cm
Net Weight| Approx.110g
External dimensions| Approx.79.8 × 72.5 × 13.2mm
Included| USB Cable, AC Adaptor, User Manual, Storage Pouch
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
Protection against ingress of water| IP22, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15°
Software version| V01
Device classification| Battery Powered Mode: Internally Powered ME Equipment AC Adaptor charged Mode:
Class II ME Equipment

WARNING: No modification of this equipment is allowed.

ACCESSORIES’

Storage Pouch:

Charging Adapter:

Adaptor

INPUT: 100-240VAC 50/60Hz 0.3A Max
OUTPUT: 5V 1000mA

Contact Information

Distributed by Ozeri
Customer service: 1-877-299-1296 or Email: support@ozeri.com (OzeriTM and its subsidiaries assume no liability for damage caused by the use of the Ozeri Blood Pressure Monitor other than for its intended use or as instructed above and in the User Manual.)

FCC Statement (USA only)
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Compiled Standards List

| USA| EU
---|---|---
Risk Management| ISO 14971:2007| EN/ISO 14971:2012
Labeling| EN 980:2008| EN 15223-1:2012
User Manual| EN 1041:2008| EN 1041:2008
General Requirements for Safety| IEC 60601-1:2005| EN 60601-1:2006/AC2010 EN 60601-1-11:2010
Non-invasive Sphygmomanometers General Requirements| ASSI/AAMI SP10：2002/A1：2003/A2：2006/(R)2008| EN 1060-1:1995+A2:2009 EN 1060-3:1997+A2:2009 EN 1060-4:2004
Electromagnetic Compatibility| EN 60601-1-2:2007| EN 60601-1-2:2007/AC:2010
Software Lifetime| EN 62304:2006/AC:2008| EN 62304:2006/AC:2008

EMC GUIDANCE

EMC Guidance

1. The Blood Pressure Monitor needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS
2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3m (11ft) away from the equipment.
   (Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)

WARRANTY  Information

Your Ozeri Blood Pressure Monitor, excluding the arm cuff, is warranted to the original owner for 5 years from the date of purchase against defects in material and workmanship under normal use. The arm cuff is warranted to the original owner for 1 year to be free from defects in material and workmanship under normal use. Should your blood pressure monitor and/or arm cuff appear defective within the applicable period from the date of purchase, return the defective unit, freight prepaid along with an explanation of the claim to Ozeri. Please pack carefully to avoid damages in transit. Under this warranty, Ozeri will repair or replace any parts found to be defective due to a manufacturer’s defect. This warranty extends only to personal use and does not extend to any product that has been used for commercial use, or use which is not intended. There ar

This warranty is not transferable. Ozeri is not responsible in any way for damages, losses or inconveniences caused by equipment failure caused by user negligence, abuse, or use not in accordance with the “User Guide” or any additional safety, use, or warnings included in the product materials. Further, Ozeri is not liable for incidental or  consequential damages of any nature resulting from the use of this product and any liability shall not exceed the purchase price of the product.

This Warranty gives you specific legal rights. You may also have other rights which vary from state to state.
T H I S W A R R A N T Y D O E S N O T A P P L Y T O T H E FOLLOWING:

Damage due to accident, misuse, abuse,alterations or vandalism.

• Improper or inadequate maintenance.
• Unauthorized modification or commercial use.
• Damage in return transit.
• Unsupervised use by children under 18 years of age.

CUSTOMER SUPPORT

Ozeri Customer Service
Customer service : 1-877-299-1296 or
Email: support@ozeri.com

(OzeriTM and its subsidiaries assume no liability for damage caused by the use of the Ozeri Blood Pressure Monitor other than for its intended use or as instructed above and in the User Manual.)

Ozeri Customer Service
Customer service: 1-877-299-1296 or
Email: support@ozeri.com

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