Medline MDS1001 Bedienungsanleitung

AUTOMATIC BLOOD

PRESSURE MONITOR

USER’S MANUAL

MDS1001

MDS1001U

MDS1001UT

TENSIOMÈTRE

AUTOMATIQUE

GUIDE DE L’UTILISATEUR

MONITOR DE PRESIÓN

ARTERIAL AUTOMÁTICO

MANUAL DEL USUARIO

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Contents

Introduction and Intended Use 3

Symbol Identiﬁcation 4

Important Safety Information 4

Measurement Accuracy 5

Helpful Information about Blood Pressure 6

Correct Method of Measurement 10

Parts Identiﬁcation 11

Preparation Before Taking a Measurement 13

Taking a Measurement 17

Memory Function 18

Error Indicators and Troubleshooting 20

Medline Blood Pressure Cuff Table 22

Care and Maintenance 23

Sensor Calibration Mode 23

Speciﬁcations 24

Blood Pressure Log 25

Warranty 74

Introduction and Intended Use

This instruction manual provides important information about the automatic digital blood

pressure monitor MDS1001 Series. This device is intended to measure the systolic and

diastolic blood pressures and pulse rate of an adult individual by using a non-invasive

technique, in which an inﬂatable cuff is wrapped around the upper arm.

Please read all of these instructions carefully, before using the monitor.

IMPORTANT NOTES

• 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 to have your physician review your procedure for using this monitor.

Never make adjustments to your medication unless recommended by your physician.

• This Blood Pressure Monitor is intended for use by adults.

Children should not use this monitor unless it is under the supervision of an adult.

• Only use the cuff(s) included with this device or offered as approved accessories.

Unapproved cuffs can affect measurement accuracy.

Symbol Identiﬁcation

The following symbols may appear in this manual, onthe blood pressure monitor, or on its accessories.

Important Safety Information

Warning

• Consult with your physician before using this device on an arm where intravascular access,

therapy, or an arteriovenous shunt is present because of temporary interference to blood

ﬂow which could result in injury.

• Consult your physician before using this device if you have had a mastectomy.

• Too frequent measurements can cause injury due to blood ﬂow interference.

• Do not apply the cuff over a wound, as it can cause further injury.

Warning

Type B: Identiﬁes applied part complying with IEC 60601-1.

Class II

Refer to instruction manual

Disposal: Do not dispose this product with household waste.

• Do not kink the cuff hose, as this may cause the cuff pressure to continuously increase,

which can interfere with blood ﬂow and result in injury.

• Do not inflate the cuff on the same limb to which other monitoring medical electrical

(ME) equipment is applied. This can cause temporary loss of function of the monitoring

ME equipment.

• Make sure that operation of this device does not result in prolonged impairment of

blood circulation.

Measurement Accuracy

The quality of the device has been veriﬁed and conforms to the provisions of the EC-Council

directive 93/42/EEC 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 system

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 in accord with requirement in section 21 of CMDR’S

Helpful Information about Blood Pressure

What is Blood Pressure?

Blood pressure is the force that blood exerts on the arteries. This force is constantly changing

as the heart beats. When the heart contracts, blood pressure reaches its highest value. This

is called systolic blood pressure. When the heart relaxes between beats, the value of blood

pressure is lower. This is called the diastolic blood pressure. The unit of measure for blood

pressure is millimeters of mercury, abbreviated mmHg. For example, an individual’s blood

pressure may be measured as 120 mmHg (systolic) and 80 mmHg (diastolic). This would be

spoken as “120 over 80” and written as “120/80”.

What Affects Blood Pressure?

Blood pressure can be affected by the following factors: eating, drinking alcohol or

caffeine, smoking, stress, exercise, physiologic condition, measurement site, body position,

temperature, humidity, altitude, and many other factors.

Remember that blood pressure can also vary throughout the day. It is important to take

measurements at the same time each day, and under the same conditions.

Typical Daily Blood Pressure Fluctuations

What is High Blood Pressure?

Hypertension, or high blood pressure, is a condition where an individual’s blood pressure

remains high over a long period of time. Consult with your physician with any questions or

concerns you may have about hypertension.

Example: 35-year-old male

Blood Pressure Classiﬁcation

The World Health Organization (WHO) and the International Society of Hypertension (ISH)

Monitor Pressure Gauge and Indicator

The pressure gauge allows quick detection of your blood

pressure classiﬁcation. The indicator displays a segment,

based on your measurement, corresponding to the WHO and

ISH classiﬁcation.

Note: The pressure gauge indicator is approximate. Please

consult your physician to interpret your blood pressure

measurements.

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Pressure

Gauge

Indicator

Pressure

Gauge

Blood Pressure Classiﬁcation Systolic (mmHg) Diastolic (mmHg)

Optimal Less than 120 Less than 80

Normal 120-129 80-84

High - Normal 130-139 85-89

Hypertension - Stage 1 140-159 90-99

Hypertension - Stage 2 160-179 100-109

Hypertension - Stage 3 180 or Higher 110 or Higher

Why is it Importantto Measure Your Blood Pressure at Home?

Having your blood pressure taken at the doctor’s ofﬁce may cause you to become nervous,

thus artiﬁcially raising your reading. Having the ability to take your blood pressure at

home makes it easy to record a log of your daily readings. This will help you gain a greater

understanding of your blood pressure reading and the factors that affect it. Be sure that you

share your information with your physician.

Hints forAccurate Measurement

1. Relax and try to remain still for 5 to 10 minutes before a measurement.

2. Remove any clothing on the upper arm so that the cuff can be placed directly on the skin.

Constricting garments may cause an inaccurate reading.

3. Perform measurements on the same arm (preferably the LEFT arm).

4. Refrain from eating, smoking and drinking (especially alcoholic beverages) before a

measurement. These activities can affect your blood pressure.

5. Remember that blood pressure varies continuously throughout the day.

Try to take your blood pressure at the same time each day.

6. Do not be concerned with the results of one measurement. Many measurements, recorded

over an extended period of time, will provide a better indication of your blood pressure.

7. Relax for 5 to 10 minutes before taking another measurement.

8. Because many factors can affect your blood pressure,daily ﬂuctuations of 25 to 50 mmHg

are common.

Please Note:

Some individuals with hypertension, diabetes, kidney disorders, arteriosclerosis or poor

circulation may see a signiﬁcant difference in blood pressure readings taken from the wrist

as compared to readings from the upper arm. It is recommended that you consult with your

physician concerning the use of this monitor.

Correct Method of Measurement

To obtain the most accurate blood pressure measurement, please follow these important

directions:

1. Sit comfortably in a chair with your back supported. Place both feet ﬂat on the ﬂoor and

keep your legs uncrossed.

2. Rest your left arm on a table and position your palm upwards.

IMPORTANT: 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.)

3. Remain still, avoid moving or talking during the measurement.

Feet Flat on Floor Position Arm at Heart Level Avoid Moving or Talking

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