HEINE EN200 BP User Manual Feb 2018

USER MANUAL HEINE ® EN200 BP

DEUTSCH

5 - 36

ENGLISH

39 - 70

FRANÇAIS

73 - 104

ESPAÑOL

107 - 138

ITALIANO

141 - 172

NEDERLANDS

175 - 206

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INHALTSVERZEICHNIS

1

ERSTE SCHRITTE

8

1.1

LIEFERUMFANG UND VERPACKUNG

8

1.2

DER STARTBILDSCHIRM

9

1.3

INBETRIEBNAHME

10

1.3.1

MONTAGE/DEMONTAGE

10

1.3.2

INBETRIEBNAHME

11

1.3.3

EIN- UND AUSSCHALTEN IHRES GERÄTES

11

1.3.4

ERSTKONFIGURATION VORNEHMEN

11

2

DIE BLUTDRUCKMESSUNG

12

2.1

VOR DER BLUTDRUCKMESSUNG

12

2.2

DIE EINZELMESSUNG

15

2.3

DIE ZWEIFACHMESSUNG

16

2.4

DIE MANUELLE MESSUNG

18

2.5

FEHLERMELDUNGEN

20

3

DER MESSWERTESPEICHER

21

4

MENÜPUNKT EINSTELLUNGEN

22

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ENGLISH

INTENDED USE The EN200 BP is an automatic, non-invasive blood pressure monitor that can be used together with an inflatable cuff for repeated, indirect blood pressure measurement without arterial puncturing. This electrically powered ME DEVICE for indirect blood pressure measurement without arterial puncturing uses an automatic method to assess the blood pressure. The device is suitable for clinic environment.

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TABLE OF CONTENTS

1

FIRST STEPS

42

1.1

SCOPE OF DELIVERY AND PACKAGING

42

1.2

THE START SCREEN

43

1.3

START-UP

44

1.3.1

ASSEMBLY AND DISASSEMBLY

44

1.3.2

SETTING UP

45

1.3.3

SWITCHING YOUR UNIT ON AND OFF

45

1.3.4

INITIAL CONFIGURATION

45

2

BLOOD PRESSURE MEASUREMENT

46

2.1

PRIOR TO MEASURING THE BLOOD PRESSURE

46

2.2

SINGLE MEASUREMENTS

49

2.3

DOUBLE MEASUREMENTS

50

2.4

MANUAL MEASUREMENTS

52

2.5

ERROR MESSAGES

54

3

THE READINGS MEMORY

55

4

SETTINGS MENU ITEM

56

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5

NOTES

57

5.1

PATIENT SAFETY

57

5.2

OPERATION, MAINTENANCE AND CARE

60

5.3

CLEANING AND MAINTAINING THE DEVICE

61

5.4

CLEANING AND MAINTAINING THE CUFF

62

5.5

CLEANING AGENTS

62

5.6

DISPOSAL INFORMATION

62

6

WARRANTY AND REPAIR CONDITIONS

62

STATUTORY WARRANTY

62

INFORMATION ON LABELLING AND SAFETY

63

LAWS AND PROVISIONS RELATED TO THE PRODUCT

63

a.

Legend – icons on the device

64

b.

Legend – icons in the instructions for use

65

c.

Technical Data

66

d.

Manufacturer declaration on EMC (electromagnetic compatibility)

68

e.

Icons in the display

69

f.

Icons of blood pressure measurement

70

7

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1

FIRST STEPS

1.1

SCOPE OF DELIVERY AND PACKAGING

First, check to ensure that the device is complete and that it does not display any damage. In case of doubt, do not start-up the device and contact your dealer or service centre. Every device is identified by a unique serial number that is placed in a clearly visible position on the rear of the device. Scope of delivery: M-000.09.202 M-000.09.091 X-000.99.204 X-000.99.305

EN200 BP as single module Coiled tubing EN200 BP USB-cord E4-USB Plug-in power supply with primary plug Instruction for use

M-000.09.201 M-000.09.091 X-000.99.203

EN200 BP for use with the EN 200 Wall Transformer Coiled tubing EN200 BP USB-cord Instruction for use

Accessories: Quick Cuff (Reusable) M-000.09.803 20,5 – 28 cm M-000.09.804 27 – 35 cm M-000.09.805 34 – 43 cm M-000.09.806 42 – 54 cm

Adult small Adult Adult large Adult XL

Quick Cuff Single Patient M-000.09.813 20,5 – 28 cm M-000.09.814 27 – 35 cm M-000.09.815 34 – 43 cm

Adult small (10 pcs.) Adult (10 pcs.) Adult large (10 pcs.)

Contact: HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 · 82211 Herrsching · Germany Tel. +49 (0) 81 52 / 38 - 0 Fax +49 (0) 81 52 / 38 - 2 02 E-Mail: [email protected] · www.heine.com WARNING: Keep packaging film out of the reach of children. Risk of suffocation!

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1.2

THE START SCREEN

The EN200 BP is equipped with an innovative touch screen. The entire navigation takes place by lightly touching the specific function icon on the display. FUNCTION SYMBOLS

Switching on/off

Home: Go back to the main screen

Back: Go back one level

”BACK“ touch button (to go back one level)

”CANCEL“ touch button

”START“ touch button

”RESET“ touch button

”DOWN“ touch button

”UP“ touch button“

”CONFIRM“ touch button

”SAVE“ touch button

”TO DELETE“ touch button

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START SCREEN

Date and time

Rapid single measurements

Double measurements

Manual measurements

Save

Setting

1.3 START-UP 1.3.1 ASSEMBLY AND DISASSEMBLY The wall plugs supplied with the product are universal wall plugs and suitable for most building materials (e.g. concrete, solid brick, brick). 1. Hold the drill template horizontally in place on the desired position and mark the drill holes. Drill a hole of at least 40 mm deep using a Ø 6 mm drill. 2. Fit wall plugs. 3. Use a suitable screwdriver to tighten the two upper screws with a distance of approx. 3 mm to the wall. 4. There is a USB port on the rear side. Connect the HEINE USB cord and run the cable via the housing canal to the outside on the left or right hand side. To do so, press the cable into the clamping hubs, which act as strain relief.

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5. Hang the device – disconnected from the mains – on the two screw heads, press firmly and push downwards. Check to make sure that the device is correctly positioned on both screw heads. 6. Additionally, the lower screw can be fixed, in order to avoid the device from slipping off the mount. If you do fix the lower screw, please stick the enclosed identification plate visibly on the bottom of the housing. For disassembly, remove the plug-in transformer from the mains socket, loosen the lower screw, push upwards and take it off the wall. 1.3.2 SETTING UP One option is to connect the USB cable to the HEINE plug-in power supply, attach the primary adapter to the plug-in power supply until it latches into place, and then connect the primary adapter to the socket. The other option is to use the HEINE® EN200 wall transformer for power supply. Primary plug

EU

USA / Japan

UK

Australia

 he device may only be operated with the supplied power supply unit. T Use only original HEINE accessories. 1.3.3 SWITCHING YOUR UNIT ON AND OFF To switch the device on, hold down the -button for about 1 seconds. The unit will switch itself off after around 2 minutes if no other buttons have been pressed in that time. On the start screen, it is also possible to switch off the unit by pressing and holding the -button for around 1 second. 1.3.4 INITIAL CONFIGURATION Switch on the unit. You will be taken directly to the initial configuration menu when first switching on your device. This is where you can perform the following settings: LANGUAGE Set the language with the navigation buttons entry with the confirmation button . This will also define the date and time format. DATE Set the current date using the navigation buttons Confirm the entry using the button .

and confirm the

.

TIME Set the current time using the navigation buttons . Confirm the information entered using the confirm button MED 113275

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2

BLOOD PRESSURE MEASUREMENT

2.1

PRIOR TO MEASURING THE BLOOD PRESSURE

Selecting the right cuff size and the correct cuff position of the blood pressure cuff are critical for successful blood pressure measurement; this is the most common source of errors for inaccurate measurements. CORRECT CUFF POSITION IMPORTANT: THE CUFF SIZE MUST BE CORRECT! The cuff for adults is suitable for an upper arm circumference of 27– 35 cm. Other cuff sizes can be selected for different arm circumferences.

Marking Artery

2 – 3 cm insert the free end of the cuff air tube into the connection provided on • First the device. the sleeve and place it over the patient’s bare left arm, above the elbow. • Open Make sure that the arm is not affected by the hitching up of the sleeve in the event of tight-fitting clothing.

cuff must be positioned about 2 finger widths above the elbow with the tube • The pointing in the direction of the wrist. The cuff itself must not be twisted at all. • The arrow printed on the cuff must be positioned over the brachial artery. • Close the cuff so that it is close-fitting but not constricting.  PLEASE NOTE: The EN200 BP has an automatic switch-off function that is triggered if the device is not used for 2 minutes. As a result, take the time to calmly position the blood pressure cuff on the arm and then confirm that it has been positioned correctly. Then switch on your device and start the blood pressure measurement.

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THE CORRECT MEASURING POSITION Perform the measurement while seated. Pay attention to the following:

• Assume a comfortable sitting position • Do not cross the legs • Place the feet flat on the floor • Support the back and arm • Place the centre of the cuff at the height of the right atrium • Relax the arm and place it on a table, for example quiet and calm during the measurement: Do not move or talk, as this • Keep could affect the measurement values. The following must be noted when taking the blood pressure:

• Seated measurement after 3 – 5 minutes of rest prior to the measurement least two blood pressure measurements at an interval of 1 to 2 minutes in • Ata seated position and additional confirmation measurements, if the first two measurements differ significantly. The averaging of the blood pressure values may be considered. the measurements in order to improve the accuracy for patients with • Repeat arrhythmias, e.g. atrial fibrillation. • The cuff must be positioned at heart height. auscultatoric methods, pay attention to the disappearance of the Korotkoff • For sounds to identify the systolic and diastolic blood pressure (phase I and V). blood pressure should be measured on both arms as part of an initial • The examination. The higher blood pressure value is the reference value. order to detect orthostatic hypotension for older patients, diabetics or • Inother common illnesses, the first measurement should take place while standing, after 1 and 3 minutes.

•

For conventional blood pressure measurements, the heart rate should be detected by feeling for the pulse (at least 30 seconds) in a seated position after the second measurement.

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THREE TYPES OF BLOOD PRESSURE MEASUREMENT USING THE EN200 BP The individual measurement methods (”rapid single measurement“, ”double measurement“ and ”manual measurement“) perfectly complement each other and were developed based on the recommendations by the ESH and the daily requirements of everyday medical practice. RAPID SINGLE MEASUREMENTS: Whether in the hospital or in the doctor’s office – each routine physical examination starts with a thorough measurement of blood pressure. The EN200 BP and accurately determines blood pressure with a fully automatic single measurement. The integrated memory documents up to 500 readings. These are then clearly displayed and available for further processing and analysis. DOUBLE MEASUREMENTS: Accurate blood pressure measurement in routine practice is even more convenient in the double measurements mode. The measurement is fully automatic and the blood pressure value is calculated from the average of two single measurements in accordance with the ”Guidelines for the prevention, detection, diagnosis and treatment of arterial hypertension“ by the German Hypertension League. This scientifically based approach corresponds to the conventional understanding of correct medical blood pressure measurement. MANUAL MEASUREMENTS supports the physician in his or her profession and is used for special groups of patients, such as pregnant mothers. The measurement is taken by auscultation with the stethoscope; only the pumping and memory is performed by the EN200 BP.

BLOOD PRESSURE MEASUREMENT TERMINOLOGY SYSTOLIC PRESSURE: ”Systole“ is the medical term for the phase of the pumping process in which the heart contracts and ejects blood. DIASTOLIC PRESSURE: the diastolic blood pressure value represents the lowest pressure in the vascular system, a base pressure, to which the vessels are permanently exposed. The MEAN ARTERIAL BLOOD PRESSURE is the mean blood pressure, i.e. the mean blood pressure independent of the systolic and diastolic fluctuations in the vascular system. PULSE FREQUENCY: the pulse frequency refers to the number of pulses for a specific unit of time (generally 1 minute).

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2.2

SINGLE MEASUREMENTS

PERFORMING THE SINGLE MEASUREMENTS

• Start your EN200 BP. • The start screen appears in the display accompanied by an acoustic signal. • Select the ”single measurement“ mode.

the blood pressure measurement cuff • onPosition the left arm. • A note on the screen asks you to double-check the position and size of the blood pressure cuff. • Confirm this screen and perform the. measurement by pressing the ”Start“-button

EN200 BP automatically slowly inflates the cuff • toThemeasure the blood pressure. The pressure display

changes constantly during inflation.

inflates the cuff until an adequate pressure • forThethedevice measurement is reached. The device then slowly

releases the air from the cuff and performs the measurement. The blinking -symbol represents the pulse.

You can terminate the measurement at any time by • pressing the -button.

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the determined blood pressure value • byIt displays indicating the systolic pressure, the diastolic

pressure, the mean arterial blood pressure and the pulse.

The EN200 BP automatically stores the measured • values in the single measurement memory. The

memory can be called up directly from this menu using the -icon.

If you want to start another manual measurements, • please press the -Button.

2.3

DOUBLE MEASUREMENTS

PERFORMING THE DOUBLE MEASUREMENTS

• Start your EN200 BP. • The start screen appears accompanied by an acoustic signal. • Select the ”double measurements“ mode.

Position the blood pressure measurement • cuff on the left arm. • A note on the screen asks you to double-check the position and size of the blood pressure cuff. • Confirm this screen and perform the. measurement by pressing the ”Start“-button

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clock icon, which changes over time, • The appears in the display; the inflation process

starts after 60 seconds. The patient should remain motionless and come to rest during this period in order to establish optimal measuring conditions.

EN200 BP automatically slowly inflates • The the cuff to measure the blood pressure.

The pressure display changes constantly during inflation.

device inflates the cuff until an adequate • The pressure for the measurement is reached.

The device then slowly releases the air from the cuff and performs the measurement. The blinking -symbol represents the pulse.

can terminate the measurement at any • You time by pressing the -button.

clock icon, which changes over time, • The once again appears in the display at the

end of the first measurement.

second measurement starts after • The a further 60 seconds.

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Once the second measurement is • complete, the blood pressure that has

been calculated appears, showing the systolic pressure, diastolic pressure, mean arterial pressure and pulse rate.

The EN200 BP automatically stores • the measured values in the double

measurement memory. The memory can be called up directly from this menu using the -icon.

If you want to start another double • measurement, press the -button.

2.4

MANUAL MEASUREMENTS

PERFORMING THE MANUAL MEASUREMENTS

• Start your EN200 BP. • The start screen appears accompanied by an acoustic signal. • Select the measuring mode ”manual measurements”.

Determine the point where the • pumping should stop.

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