BIOS Diagnostics ULTRA Precision 10.0 Bedienungsanleitung

Blood Pressure Monitor

ULTRA

With Atrial

Fibrillation Screening

Instruction Manual

Model: 3MS1-4Y

www.biosmedical.com

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06.05.21

Trusted by Canadians for 3 Generations

At BIOS Diagnostics™, we are proud of our legacy in blood pressure monitoring in

Canada. From the early 1930’s to 1987 we manufactured “Tycos” brand professional

blood pressure equipment for doctors and hospitals in Canada.

In the 1970’s we pioneered the ﬁrst blood pressure devices for monitoring at home,

and in the 1980’s we introduced digital technology in Canada. We haven’t been

counting, but we know that millions of our home-use monitors have been used by

Canadians in the last 30 years.

All BIOS Diagnostics™ devices are developed in collaboration with physicians and

clinically tested to prove their measurement accuracy. For more information on

clinical tests and other BIOS medical products, visit our website at

www.biosmedical.com.

If you have questions about this device or blood pressure monitoring at home, email

us at: [email protected] or call the BIOS Medical Hotline 1-866-536-2289.

BIOS VP of Marketing - Mark Beaton accepts the 2017 Hypertension Canada Certiﬁcate of

Excellence from Angelique Berg, CEO of Hypertension Canada

Ultra Blood Pressure Monitor with Atrial Fibrillation Screening

Instruction Manual

Table of Contents

1. Introduction

1.1 Features

1.2 Important Information

1.2A Safety Information

1.2B Care of the Device

1.2C Comparing Readings to Other Blood Pressure Devices

1.2D Calibration

1.3 What Do Your Numbers Mean?

1.4 Normal Blood Pressure Values

1.5 Common Blood Pressure Questions and Answers

1.6 About MAM Technology

1.6A Why Use MAM?

1.6B Key Advantages

1.6C Medical Beneﬁts

1.6D Measurement Sequence

1.7 Important Facts about Atrial Fibrillation (AFIB)

1.7A What is Atrial Fibrillation?

1.7B How Does AFIB Impact my Family or Me?

1.7C AFIB Detection Provides a Convenient Way to Screen for AFIB (only in MAM mode)

1.7D Risk Factors You Can Control

2. Getting Started

2.1 About the 3MS1-4Y

2.2 About the LCD Screen

2.3 Inserting the Batteries

2.4 Using the AC Adapter

3. Using the Device

3.1 Setting the Time and Date

3.2 Measurement Mode Selection (MAM or Single)

3.3 Obtaining Accurate Measurements

3.3A Tips on Taking Accurate Measurements

3.3B Common Sources of Error

3.3C Fitting the Wide Range Cuff

3.4 Measuring your Blood Pressure

3.5 Appearance of the Atrial Fibrillation Indicator (only in MAM mode)

3.6 BP Assessment Indicator

3.7 Viewing Previously Recorded Values

3.8 Clearing All Values

3.9 Discontinuing a Measurement

3.10 Determining Your “Real“ Average Blood Pressure at Home

4. Software Functions

5. Error Messages / Malfunctions

6. Care and Maintenance

7. Lifetime Limited Warranty

8. Technical Speciﬁcations

1 Kearley K, Selwood M, Van den Bruel A, Thompson M, Mant D, Hobbs FR et al.: Triage tests for identifying atrial ﬁbrillation in primary

care: a diagnostic accuracy study comparing single-lead ECG and modiﬁed BP monitors. BMJ Open 2014; 4:e004565

2 Wiesel J, Arbesfeld B, Schechter D: Comparison of the Microlife blood pressure monitor with the Omron blood pressure monitor for

detecting atrial ﬁbrillation. Am J Cardiol 2014; 114:1046-1048

1. Introduction

Thank you for purchasing the BIOS Diagnostics™ Ultra Blood Pressure Monitor with Atrial Fibrillation

Screening. Designed for convenient and easy operation, this device provides a simple, yet accurate

method to measure your blood pressure.

Your blood pressure is an important parameter that can be used to monitor your health. This device

enables you to monitor your blood pressure regularly, and maintain a record of your blood pressure

measurements. You can then use this record to assist your physician in diagnosing and maintaining a

healthy blood pressure level.

1.1 Features

The 3MS1-4Y is a fully automatic, digital, blood pressure measuring device with a unique fuzzy logic

technology as well as patented MAM and AFIB technologies. It can store up to 200 blood pressure

readings.

It provides a fast and reliable measurement of systolic and diastolic blood pressure as well as heart rate

using the oscillometric measurement method.

AFIB detection is the world’s leading digital blood pressure measurement technology for the early

detection of atrial ﬁbrillation (AFIB) and hypertension. These are the two top risk factors of heart disease

and stroke which increase the risk of getting a stroke or heart disease in the future. It is important to

detect AFIB and hypertension at an early stage, even though you may not experience any symptoms.

Appropriate treatment can reduce your risk of suffering a stroke. For this reason, it is recommended that

you visit your doctor when the device gives an AFIB signal during your blood pressure measurement. The

AFIB algorithm has been clinically investigated by several prominent clinical investigators and showed

that the device detects patients with AFIB at 97-100% certainty. 1,2

• MAM - Averaging Mode technology used in the device provides accurate measurements. Using

three consecutive measurements, your result is calculated and displayed as a single averaged

measurement on the display screen.

• AFIB - Atrial Fibrillation Detector technology icon is displayed when atrial ﬁbrillation is detected

during a blood pressure reading.

• Blood Pressure Analyzer Software allows you to download, record and chart your readings to

accurately monitor your daily readings. The Blood Pressure software can be downloaded for free from

www.biosmedical.com

This powerful medical tool automatically stores all your blood pressure readings. By clicking the

viewing options the user can review the readings in multiple forms including: by date, morning vs.

evening readings, isolated systolic or diastolic or pulse. The automatic graph clearly shows your

blood pressure history with highs and lows. Charts and graphs can even be printed or emailed to your

doctor!

This device is easy to use and has been proven in clinical studies to provide excellent accuracy. Before

using the 3MS1-4Y, read this instruction manual carefully and keep it in a safe place.

1.2 Important Information

Refer to the following sections to learn about important safety instructions and how to take care of the

BIOS Diagnostics™ Ultra Blood Pressure Monitor with Atrial Fibrillation Screening.

1.2A Safety Information

• Self-measurement means control, not diagnosis or treatment. Your values must always be discussed

with your doctor or a physician who is familiar with your family history.

• If you are undergoing medical treatment and receiving medication, consult your doctor to determine

the most appropriate time to measure your blood pressure. Never alter the dosages of any medication

without direction from your doctor.

• Your blood pressure depends on several factors, such as age, gender, weight and physical condition. It

also depends on the environment and your state of mind at the time of measurement. In general, your

blood pressure is lower when you are asleep and higher when you are active. Your blood pressure may

be higher when recorded at a hospital or a clinic and may be lower when measured in the relaxing

comfort of your home. Due to these variations, we recommend that you record your blood pressure

regularly at home as well as at your doctor’s clinic.

• Try to record your blood pressure regularly at the same time of the day and under the same conditions.

This will help your physician detect any extreme variations in your blood pressure and thus treat you

accordingly.

• Morning Hypertension (> 135 / 85 mmHg): Recently, several studies have identiﬁed elevated

cardiovascular risks (heart failure, stroke, angina) associated with “morning hypertension”. There is a

typical rise in blood pressure during the physiological changes from sleep to arising for the day.

• The ideal time to measure your blood pressure is in the morning just after you wake up, before

breakfast and any physical activity, and in the absence of the urge to urinate. If this is not possible, try

to take the measurements later in the morning, before you start any physical activity. Relax for a few

minutes before you record your blood pressure.

• Your blood pressure increases or decreases under the following circumstances:

Blood pressure is higher than normal:

— When you are excited, nervous, or tense

— While taking a bath

— During and after exercise or strenuous physical activity

— When it is cold

— Within one hour after meals

— After drinking tea, coffee, or other caffeinated drinks

— After smoking tobacco

— When your bladder is full

Blood pressure is lower than normal:

— After consuming alcohol

— After taking a bath

• The pulse display is not suitable for checking the frequency of heart pacemakers.

• If you have been diagnosed with a severe arrhythmia or irregular heartbeat, vascular constriction,

liver disorders, or diabetes, have a cardiac pacemaker, or are pregnant, measurements made with this

instrument should only be evaluated after a consultation with your doctor.

• Take care while handling the batteries in the device. Incorrect usage may cause battery ﬂuid leakage.

To prevent such accidents, refer to the following instructions:

— Insert batteries with the correct polarity.

— Turn off power after use. Remove and store the batteries if you are not planning to use the device

for an extended period of time.

— Do not mix different types, brands, or size of batteries. This may cause damage to the product.

— Do not mix old and new batteries.

— Remove batteries and dispose of them according to the proper regulations in your area.

— Do not disassemble batteries or expose them to heat or ﬁre.

— Do not short-circuit the batteries.

— Do not use rechargeable batteries.

1.2B Care of the Device

For prolonged life of your blood pressure monitor, note the following instructions:

• Do not drop or bang the unit. Prevent sudden jerks, jars, or shocks to the device to prevent damage.

• Do not insert any foreign objects in any device openings or vents.

• Do not disassemble the unit.

• If the unit has been stored at very low or freezing temperatures, allow to reach room temperature

before using it.

• Do not store the unit in direct sunlight, high humidity, or in places with a lot of dust.

• Clean the device with a soft dry cloth. Do not use gasoline, thinner or similar solvents. Carefully

remove spots on the cuff with a damp cloth and soap. Do not wash the cuff.

• Do not use the device if you think it is damaged or if anything appears unusual.

• Ensure that children do not use this device unsupervised;some parts are small enough to be

swallowed.

• Using the unit in the immediate vicinity of mobile phones, microwave appliances or other devices with

strong electromagnetic ﬁelds may result in impaired functioning.

• Do not use this device close to strong electromagnetic ﬁelds, such as mobile telephones or radio

installations. Keep a distance from such devices when using this unit.

1.2C Comparing Readings to Other Blood Pressure Devices

Many questions arise when two blood pressure devices are compared in an effort to check accuracy. An

accurate comparison requires repeatable measurements under the same conditions to “reference device”

with known accuracy. Signiﬁcant time is required to reduce naturally occurring blood pressure variability

during the test. The subject should be seated comfortably with feet ﬂat on the ﬂoor, and have rested for 5

minutes before the ﬁrst reading to allow blood pressure levels to stabilize.

The patients back, elbow and forearm should be supported, and the middle of the cuff should be at the

level of the right atrium. There should be no talking or moving during the measurement and if comparing

to an aneroid gauge or mercury column, observers should avoid parallax and be careful not to round

measurements.

The most accurate way to compare devices is to take two readings at the same time. However, most

people and doctor’s ofﬁces do not have the equipment necessary to measure blood pressure from

two devices simultaneously. To take sequential measurements properly requires a pair of initial

measurements to determine the subjects blood pressure level: ﬁrst with the reference equipment,

followed by 60 seconds, then with the monitor-under-test. The actual accuracy test requires three

pairs of measurements with 60 seconds between measurements. These measurements are averaged

and a comparison can be made. Since most people tend to relax and their blood pressure falls with

subsequent measurements, following this protocol reduces these natural changes in Blood Pressure

levels. The standard technical error of both consumer and professional devices is normally ±3 mmHg, so

a discrepancy of 6 mmHg is acceptable even when the devices are working within their speciﬁcations.

Any comparisons without a known “reference device” and not following the procedures described above

will yield unreliable results. In addition, to do an accuracy test properly the reference device must also be

tested to a known reference to conﬁrm its accuracy, prior to being used as the reference for comparisons.

1.2D Calibration

Digital blood pressure monitors do not require regular recalibration, unless the product has been dropped

and internal parts have been damaged. If the unit turns on and does not display an error code, the product

is working properly. In extremely rare cases, the cuff may have developed a pin-hole leak, or the gasket

where the cuff connector enters the monitor may not have a proper seal; both of these leaking air issues

will potentially cause errors in accuracy, but otherwise the product will work accurately without drifting

out of calibration.

1.3 What do your Numbers Mean?

Blood pressures is the pressure in your blood vessels while blood circulates throughout your body.

High blood pressure or “Hypertension” is the pressure at which ones normal average blood pressure

is considered too high and other health risks including: heart attack, stroke, dementia, kidney failure,

heart disease and erectile dysfunction may occur. It is expressed as two numbers: systolic/diastolic

120 mmHg/80 mmHg (mmHg = millimeters of mercury). “Systolic” numbers refer to the pressure on the

walls of your arteries while the heart is contracting and pushing blood. “Diastolic” pressure is the lower

number when the heart is at rest and relaxed. A simple way to understand this is to picture a garden

hose. When the tap is turned on, the immediate pressure on the walls of the hose is the “systolic” value,

and when the tap is turned off it is the “diastolic” number.

There are many different causes of high blood pressure. We differentiate between common primary

(essential) hypertension, and secondary hypertension. The latter group can be ascribed to speciﬁc organic

malfunctions. Please consult your doctor for information about the possible origins of your own increased

blood pressure values.

1.4 Normal Blood Pressure Values

Blood pressure is too high when measuring at home and you have rested, the diastolic pressure is above

85 mmHg or the systolic blood pressure is over 135 mmHg. If you obtain readings in this range, consult

your doctor immediately. High blood pressure values over time can damage blood vessels, vital organs

such as the kidney, and your heart.With blood pressure values that are too low (i.e., systolic values under

105 mmHg or diastolic values under 60 mmHg), consult with your doctor.

Systolic Diastolic Comment

Below 120 Less than

80 This range is considered “Normal” and ideal

120 - 139 80 - 89

This range is considered “Pre-hypertension”. Discuss with your

health care professional. Lifestyle modiﬁcations maybe required to avoid

advancing into hypertension.

140 - 159 90 - 99

This is in the “hypertension” range. Discuss with your health care

professional. Medication(s) and lifestyle modiﬁcations are typical

treatments.

160 and

higher 100 + Discuss with your medical professional, medication(s) and lifestyle

modiﬁcations are necessary to control your hypertension

Adapted From: Understanding and Managing your blood pressure; Hypertension Canada.

Note: A diagnosis of high blood pressure must be conﬁrmed with a medical professional. A

doctor should evaluate any unusual blood pressure readings. Additionally, lower targets may

be appropriate for some populations such as African-Americans, the elderly, or patients with

underlying issues such as diabetes mellitus or chronic kidney disease.

Important for Canadians:

* Hypertension measured at home ≥135/85

* Hypertension measured at a physician’s ofﬁce ≥140/90

* Hypertension measured at a physician’s ofﬁce for a diabetic patient ≥130/80

For further information, see our website www.biosmedical.com.

1.5 Common Blood Pressure Questions and Answers

a) Why is my blood pressure reading always different?

Your blood pressure changes constantly. It is quite normal for blood pressure to ﬂuctuate as much as 50

mmHg throughout the day. Blood pressure is normally lowest at night, but increases during waking hours

when the stress and activities of everyday life are highest.

mmHg

AM Time PM

b) Why is the doctor’s reading different from the reading taken at home?

Your blood pressure can vary due to the environment (temperature, nervous condition). When measuring

blood pressure at the doctor’s ofﬁce, it is possible for blood pressure to increase due to anxiety and

tension, this is known as “White Coat Hypertension”. Home blood pressure monitoring has been known

to predict health outcomes better than ofﬁce blood pressure measurements.

c) Why should I monitor blood pressure at home?

One or two readings will not provide a true indication of your normal blood pressure. It is important to

take regular, daily measurements and to keep records over a period of time. This information can be used

to assist your physician in diagnosing and preventing potential health problems. Expert opinion suggests

patients with normal blood pressure can beneﬁt from one week of measuring every three months.

1.6 About MAM Technology

(Average Mode) technology is a new technology that enables optimum reliability in self-measurement of

blood pressure.

An advanced measurement accuracy is achieved by the automatic analysis of three successive

measurements, with short rest periods in between (see diagram 1).

This new technology provides reliable values for the doctor and can be used as the basis for reliable

diagnostics and medication therapy for high blood pressure.

• Reliable patient self-measurement data for the doctor

• Safe hypertension diagnostic tool

• Reliable therapy control

1.6A Why Use MAM?

• Human blood pressure is not stable

1.6B Key Advantages

The technology provides reduction in:

• Device scattering

• Insufﬁcient rest prior to measurement

• Movement effects (i.e. coughing, talking, movement)

• Cuff positioning inﬂuences

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