Arterial Stiffness Monitor (BioClip-Cuff™)

Product Description

BioClip-CUFF^®– monitoring your vascular condition

The BioClip-CUFF^® is a simple way of assessing both your blood pressure condition and your arterial flexibility; plus, you can use the BioCUFF^™ in the comfort of your own home because you simply attach the device to your arm just like an ordinary blood pressure cuff.

What does the BioClip-CUFF^® measure?

The BioClip-CUFF^® provides a series of metabolic indicators that you can use to improve your lifestyle and so help to prevent the causes of cardiovascular disease. We all know the risks of being overweight, of having high cholesterol or suffering from high blood pressure. We also know how to reduce those risks -by exercising more, not smoking, reducing our alcohol intake and eating a balanced diet.

These include:

• Diastolic blood pressure
• Systolic blood pressure
• The heart rate
• Vascular condition -which linked to arterial flexibility. Few of us know about the hidden dangers of arterial inflexibility, or how to measure it. This is where the BioCUFF^™ is unique being as it is the first at-home device able of delivering this information to you within minutes.

What is arterial flexibility?

The BioClip-CUFF^® works by evaluating your arterial flexibility, which experts say is one of the most important risk factors when it comes to assessing the likelihood of a heart attack or stroke. Arteries are important because they’re responsible for blood flow around your body via your cardiovascular system. To work properly, it’s crucial that your arteries are kept healthy.

The poorer your vascular condition, the greater your chances of serious health issues

Our arteries usually stiffen with advancing age. This brings with it a greater risk of a potentially fatal heart attack, heart failure or stroke, as is shown in figure 1.

Figure 1: Arterial stiffness is a biomarker of aging, as shown here arterial stiffness tends to increase with age. Source: Millasseau et al., Clinical Science, 2002

You may not recognise the heart failure symptoms as your arteries begin to stiffen

Unfortunately arterial stiffness can occur without warning. Often there are no symptoms of cardiovascular disease and people don’t suspect they are in danger until they suffer an attack. Figure 2 highlights that arterial stiffness is strongly correlated with mortality.

Figure 2: Three groups (each approximately 80 persons) were monitored over 140 months for their survivability. Those in the flexible artery groups (marked as PWV <9.4 m/s and 9.4-12.0 m/s) survive best losing approx. 25%. But those in the hard artery group (marked as PWV >12.0 m/s) 90% of them die in the same period. Source: ESRD, Blacher et al. Journal of Circulation, 1999

How the BioClip-CUFF^® helps you

The BioClip-CUFF^® provides a cardiovascular condition scale, shown by LED bars- that are either within the green zone (good), yellow zone (fair) or red zone (poor) – see figure 3.

It is important to note that like blood pressure, vascular condition should be monitored over time and not just taken as one reading. The BioClip-CUFF^® makes this simple by averaging your tests over time and therefore provides a more accurate result.

Q. My arterial stiffness results are fluctuating a lot what is wrong?

A. Check that there are no air leaks from the cuff or the pipe and check the connection of the pipe into the unit. Also check the condition of the batteries and replace them if necessary.

Q. There are changes in the arterial stiffness readings when I measure back to back- why?

A. The BioClip-CUFF^® is designed to give an average reading over time, ideally over a 2-4 week period, so you should use the average facility to determine your arterial stiffness- as well as blood pressure etc.

Q. How can I get the best out of the device?

A. Follow the instructions carefully; for example, try to always test at the same time of day, don’t eat or drink anything an hour before a test, be relaxed and calm beforehand, make sure the cuff is properly attached to a naked arm and is at the same height as your heart.

Q. Can I improve my arterial stiffness results?

A. Yes you can and IAS has published on this subject. There are both lifestyle choices as well as supplements that can make a significant difference within several weeks. Please contact us for further details.

Indications for use:

The device is a non-invasive monitor intended for use in measuring blood pressure and pulse rate in adult population.

The device also estimates the arterial complicance (elasticity of arterial wall) during measurement and gives an indication with readings.

The device is not intended to be a diagnostic device.

Important Notes

Please read the entire manual carefully before using this Arterial hardness & Blood Pressure Monitor.

Only a physician is qualified to interpret changes in your blood pressure. This device is not intended to replace regular medical examinations. It is recommended that your physician review your procedure for using this monitor. Never make adjustments to your medication unless it is the advice of a physician.

Warning

This device is intended for adult use. Do not allow children to play with this device.

Do not wrap the cuff around any parts of the body other than an adult’s arm.

Substitution of a component different from that supplied might result in measurement error.

Caution

The H-Value technology requires 5 to 15 minutes rest before taking every measurement.

USER’s GUIDE

What is Arterial Hardness Indication and How to Interpret the Results Correctly?

Regular medical check-ups play an important role in your personal health management. We hope this Arterial Hardness Indication (H-Value) will motivate you to lead a healthier lifestyle, and it could also act as a reminder for you not to forget your regular check up, or even seek an earlier appointment (e.g. If the average of H-Value constantly indicated 7-8 bars).

Besides measuring blood pressure and pulse, this device also estimates the compliance (elasticity) of your brachial artery during blood pressure measurement. This H-Value indication is a result of the measurement on brachial artery, which may or may not reflect the arterial hardness condition of the entire body.

Definititions

1) Arterial Hardness -Arterial hardness describes a biological change in the physical property of the arteries in particular the property of elasticity. If hardening of the arteries is not controlled, it can lead to further complications in the blood vessels of the heart and the brain. The harder your arteries are, the less elastic they are. This unique technology has been given three different names as AHI (Arterial Hardness Indication) or ASI (Arterial Stiffness Indication) or H-Value (degree of arterial hardness).

2) Arteriosclerosis -This means a person’s arteries have hardened to such a serious degree that a physician would diagnose it as a disease. Such disease may induce Stroke or Heart Attack etc. The degree of Arteriosclerosis is difficult to diagnose since it progresses slowly and silently. Caution: This device does not estimate Arteriosclerosis.

Correct Steps and Procedure

1) A single measurement of BP and H-Value reflects only the moment of measurement, similar to BP, the H-Value fluctuates due to emotion, stress, nervousness, temperature and some medications.

Daily fluctuations (2-5 bars) of H-Value is considerably normal.

2) The best use of this unique technology is to help you to monitor the current status and the future trend of your arterial hardness. You must build a base of the AVERAGE of your H-Value by taking around 30 measurements. When turning the power off, the LCD display will show the AVERAGE value from all the previous measurements. (30 maximum)

It helps to remind and motivate you to decrease (or least to maintain) the AVERAGE number of bars, either by improving your lifestyle or consulting your doctor.

Classification: Blood Pressure

The classifications provided in this manual are recommendation for reference only and are revised by their respective publishers from time to time. They are for reference only, and must not be sued for self-diagnosis by patients. Any treatment or medication adjustment must be given by doctors only.

The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure has published the following chart to classify blood pressure:

Category	Systolic (mm/Hg)		Diastolic
Normal*	Less than 120	and	Less than 80
Pre-hypertension	120-139	or	80-89
Hypertension
Stage 1	140-159	or	90-99
Stage 2	160 or higher	or	100 or higher

*Unusually low reading should be evaluated for clinical significance.

Hints for Accurate Measurement.

1) Rest 5-15 minutes before taking a measurement, and remain still during testing.

2) Remove any heavy clothing on the upper arm (shirts are acceptable). Constriction of the upper arm caused by rolling up a shirt sleeve may cause an inaccurate reading.

3) Refrain from eating, smoking, and drinking (especially alcoholic beverages) before a measurement. These activities can affect your blood pressure.

4) Do not be concerned with the results of one measurement. Many measurements, recorded over a long period of time will provide a better indication of both your blood pressure and / or arterial hardness.

5) Please relax for at least 5 minutes before taking another measurement.

6) Many factors can affect your blood pressure and / or arterial hardness indication, such as exercising, eating, talking, moving, nervousness, environment and temperature changes. Emotional stress can cause an increase in blood pressure, and / or the arterial hardness. Daily fluctuations of 25 to 50mmHg or up to 3 bars are common for many people.

7) Remember that blood pressure and arterial hardness vary continuously throughout the day. Try to take your arterial hardness reading at the same time each day.

Correct Posture of Measurement

To obtain the most accurate blood pressure and H-Value measurement, please follow these important directions.

Be seated in a chair with back support

Rest your arm on a table to the cuff is at the same level as your heart

Place both feet on the ground.

NOTE: The arm cuff must be at the same level as your heart, or accurate measurement will not be possible. (Your heart is located slightly below your left armpit.) If the cuff is 10cm higher or lower than the heart, then the blood pressure will be 8mm/Hg lower or higher.

Device Preparation

Battery Installation / Replacement

1) Flip open the batter cover in the direction of the arrow

2) Install or replace the four alkaline AA batteries, noting the proper orientation of positive and negative terminals of the batteries in the battery compartment.

3) Replace the batter cover

4) If the Low Battery Symbol appears on the display, replace all batteries with new ones. Do not mix with any old battery, it will cause the new batteries to die very quickly.

5) Remove the batteries if the unit will not be used for an extended period of time.

Note: Batteries are hazardous waste. Do not dispose with the household garbage.

Note: The following battery replacement procedure will help you keep the measurement memory, inflation level and the date / time setting.

1) Replace one battery at a time. You have about 10 seconds for changing each battery before the memory and other settings are deleted.

2) Do not touch any button when charging the battery.

Setting Date and Time

For saving subsequent measurements with correct date and time, you have to set date and time after installation of batteries.

1) After the batteries have been properly installed, “0:00” and “1-1” will appear as time and date respectively.

2) Press the Mode button repeatedly; the individual figure will start blinking sequentially from month, day, hour, then to minute.

3) After you have selected a desired column (month, day, hour or minute), indicated by the blinking digit, press the Adjust button to make adjustment to the current date and time.

4) After setting the correct date and time, press the Mode button or Start / Stop button to exit the date / time setting mode.

Note: When the batteries are removed from the device, date / time needs to be set again.

How to Apply the Arm Cuff

(Preferably on the left arm)

1) Insert the end of the cuff through the metal D-ring to make a loop (Make sure that the Velcro stays outside when it is done)

2) Wear the arm cuff with the hose downward. Pull the end of the cuff and secure it snugly with the Velcro.

3) Adjust the cuff that the bottom edge is about 1 inch above the elbow on the inside of the left arm. Pelase mind the red button on the cuff covers the brachial artery.

4) Plug in the air tube connector tightly to the monitor.

Setting Inflation Level

Press Adjust button to select the proper inflation level. There are 3 preset levels: 180, 210 and 240 mm/Hg. Start taking measurements with the level 180 mm/Hg. If the setting is too low, the device will automatically re-inflate to a higher setting. If the device re-inflates every time you take a reading, you are advised to set the inflation level one level higher. It is not necessary to set inflation level every time you take a reading. If you do not change the inflation level, the unit will inflate to the level set previously.

By removing the batteries, the unit will reset the pressure setting to 180 mm/Hg.

Taking a Measurement

Please review the previous sections on proper placement of the cuff and proper arm position.

1) After the cuff has been properly placed on either the right or left arm, press the Start / Stop button. All symbols on the LCD display will appear momentarily follow by inflation level.

2) After the display reads “0”, the cuff will automatically inflate to the preset pressure, and will then begin to slowly deflate.

Note: If a downward arrow sign is displayed instead, unplug the tube and press the cuff to force out the remaining pressure. Plug the tube and continue.

3) The heart symbol will appear indicating that the measurement is in progress. The cuff will be quite snug for a short while, this is normal. Try to remain relaxed, refrain from talking, and be as still as possible during the measurement.

4) After a successful measurement, the unit deflates the cuff and displays the result on the LCD.

Note: to end a measurement for any reason, just press Start / Stop button to turn off the unit and the cuff pressure will be released.

Note: If during a measurement the power drops to an insufficient level, the unit will end the measurement and display the low battery symbol. Please replace the batteries (alkaline type).

Note: If the unit cannot detect your pulse, it will end the measurement attempt. It could be that the cuff was put on loosely. Relax for a few minutes, make sure that the cuff is put on properly and try again.

Note: The unit will automatically shut off 3 minutes following a reading, or it can be turned off manually by pressing the Start / Stop button.

Arterial Hardness Indicator

After your first blood pressure reading, the unit displays your arterial hardness average in the Arterial Hardness Indicator section of the LCD display with current date and time when you turn off the unit. For more information on Arterial Hardness Indicator please refer to Part One: User’s Guide.

Memory Record

This unit has a memory feature. When a valid measurement is made, the data is stored in the memory automatically when the unit is turned off, automatically shuts off, or when another measurement is initiated.

The unit is capable of storing 30 readings and computes the average from all the reading results in memory. When the 30 memories are full, the oldest records will be deleted as the new readings are being recorded, and the memory will maintain a moving average of the latest 30 readings.

Memory Recall

To recall your readings, press the Memory button. The average will be displayed first, indicated by No-A on the upper right hand corner. Two seconds later the Date / Time will be displayed. After alternatively displayed twice, the unit will exit memory mode and Return to Arterial Hardness Indicator display if the Memory button is not pressed again before it exits the memory mode.

Note: Smaller memory number represents newer entry. Up to 30 previous readings can be recalled. You may press the Start / Stop button at any time to exit memory mode and return to stand-by mode.

Memory Erase

If you let anyone else use this unit, that person’s reading result will be stored. To prevent memory mix up, you should erase that person’s reading record(s). To erase a record, press the Memory button to enter the memory mode. Press it again to see “No-1” shown on the display. Press and hold the Adjust button until you see “clr” appears on the display. The device will return to stand-by mode automatically, which is an indication that you have successfully erased the record. Repeat the same procedure if that person took more than one reading. No matter how many readings a person takes, you would always erase the record that display “No-1”. For example, if you took three readings, you would erase record “No-1” three times.

Note: when taking a measurement, the memory button is inactive.

Note: When the batteries are removed from the device, all records of reading will be erased. If you want to keep the memory and other settings, please refer to the Battery Installation / Replacement section.

Troubleshooting, Maintenance and other Information

Error Indicators:

Display	Possible Causes of Error
ERR 330	Indication	Cuff pressure reaches 330 mm/Hg
	Cause	Twisted bladder inside of the cuff
	Correction	Make sure that the bladder lays flat within the cuff
ERR	Indication	Display Err, cuff pressure releases and “0” pressure display
	Cause	Excessive arm movement or talking during measurement
	Correction	Take the measurement again while keeping still
	Indication	Could not obtain pulse rate
	Cause	Cuff was loosely applied, extremely weak pulse, or arrhythmia
	Correction	Reapply cuff and measure again
Pul Err	Indication	Could not obtain pulse rate
	Cause	Cuff was loosely applied, extremely weak pulse or arrhythmia
	Correction	Reapply cuff and measure again
Picture of battery crossed through	Indication	Batteries are exhausted
	Correct	Replace with four new alkaline AA batteries*

*For safety and efficacy reason, this device requires high level of voltage to maintain operation. Therefore, the batteries deem unusable for this device still hold 2/3 of capacity. For environmental consideration, please try to use them for other devices that require less voltage, such as radio or devices without moving part (motor) before discarding them.

Troubleshooting

Problem	Recommended Action
Nothing appears in display	Make sure that the batteries are installed in the proper direction (Polarity matches to the indication in the batter case)
No measurement occurs	Check the cuff is positioned properly, go over the measurement procedure again
Blood pressure reading is higher or lower than usual, or the readings fluctuate	Check if the cuff is positioned properly. Rest your arm on a table so that the cuff is level with your hear during the measurement. Please read section on Measurement Fluctuation and Correct posture of Measurement.

Care and Maintenance

· Keep the unit out of high temperatures, high humidity and direct sunlight.

· Keep sharp objects away from the cuff

· Do not press the Start / Stop button without the cuff around your arm to avoid excess pressure to build up, which may damage the cuff

· Use the unit at a sufficient distance with strong electrical fields, such as television, microwave ovens, X-ray equipment etc

· Do not subject the unit to strong impacts, or drop it on the floor

· Remove the batteries when the unit is to be stored for extended periods of time to prevent chemical leakage from the batteries, which will damage the unit.

· Use only a soft, dry cloth to clean the unit. Do not use solvents or other petroleum based cleaners.

· This devise requires no recalibration unless it is dropped to the floor, or other high impact situations

· Circuit diagram and repairable part can be provided if it’s necessary.

Note: Removing the batteries will erase all readings in memory, and reset Date and Time

Sensor Calibration Mode

You need proper equipment to calibrate this device; therefore do not attempt to do this by yourself. You may damage the unit. If by accident, you enter into the calibration mod by pressing the Memory button and the Start / Stop button at the same time, you will see two zeros appear in the LCD. Press the Start / Stop button to exit the calibration mode.

AC/DC Adaptor

If you would like to buy an AC/DC adaptor, please pay attention to the voltage and amp requirements stated in the Specification section.

Measurement Accuracy

The blood pressure measuring device bears the CE (conformity) label “CE 0044”. The quality of the device has been verified and conforms to the provisions of the EC council directive 93/42/EEC on medical devices, as well as the EMC directive 89/336/EEC:

EN 1060-1

Non-invasive blood pressure measuring equipment General requirements

EN 1060-3

Non-invasive blood pressure measuring equipment Supplementary requirements for electro-mechanical blood pressure measuring systems

EN 60601-1

Safety requirements for medical electrical equipment

EN 60601-1-2

Electromagnetic compatibility and safety for medical electrical equipment

EN 14971

Risk analysis for medical devices

Specification

Model	V201
Measuring Method	Oscillometric
Memory Function	Storage and recall of 30 measurements with average
Display	Digital LCD
Measuring Range	Pressure: 20-280mm/Hg Pulse: 40-180 / minute
Sensory Accuracy	Pressure: +/- 3mm/Hg
Inflation system	Auto inflation with 3 preset pressure levels (180 / 210 / 240 mm/Hg)
Deflation system	Computer controlled linear deflation / exhaust Valve
Arm size ranges	22-33cm (9 -13 inches)
Batteries / Adaptor	a) 1.5V alkaline (LRC6 / AA) x 4 b)DC 6V 800mA
Automatic Power Off	Approx 3 minutes after measurement
Reference method for clinical trials	Auscultatory measurement
Weight	Approx 521g (without batteries)
Storage and transportation	-10C ~+60C, 10%~95% RH
Operating Conditions	+10C ~ +40C, 10% ~ 85% RH
Standard Cited	EN 1060-1 EN 1060-3 EN 147971 EN 60601-1 EN 60601-1-2