Medilife PC3 - Blood pressure monitor BOSO - Free user manual and instructions

USER MANUAL Medilife PC3 BOSO

Coiled black cable with connectors, no visible text or symbols

Line drawing of a human hand holding a blood glucose meter (no text or symbols present)

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M 888 SYS. mm/Hg 888 DIA. mm/Hg 38:88 PUL/min

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Blutdruckmessung

Pure electrical circuit lines without any symbols

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Achtung:

Product features....41

Contents of package....42

Quick guide....43

Introduction 44

Blood pressure values 46

Systolic and diastolic blood pressure value....46

WHO blood pressure cut-off values....46

Starting up 48

Inserting batteries....48

Battery status....49

Changing batteries....49

Setting the time and date....55

General instructions for self-measurement....52

Preparing to measure your blood pressure....54

Table of contents

Note on cuff sizes....54

How to wear the unit....55

Measuring your blood pressure....58

Interrupting a measurement 59

Measurement display 60

Recall of stored readings....62

Installation of the boso profile-manager / Data transfer 63

Error messages....65

Cleaning and Disinfection....68

Warranty 68

Customer service / Disposal....69

Technical data....70

Calibration checks - Testing instructions

(for trained specialist staff only)....73

Product features

battery compartment connector jack for PC-connecting cable SET button M 120 94 66 START button LCD display boso medilife PC3

Battery status display see page 49

Measurement in progress see page 59

Irregular heartbeat during measurement see page 61, 67

Stored value see page 62

Contents of package

1 Blood pressure monitor boso medilife PC3
1 Case
1 CD boso- profile-manager
1 PC connecting cable

XSD Immobile PC3 120 94 66

Coiled black cable with connectors, no visible text or symbols

1 Warranty certificate
2 LR 03 (AAA)
1 User instructions

CERTIFICATE OF WARRANTY BOSO GARANTIE-URKUNDE CERTIFICATE OF GARANTIA PACH, 2016 S. JUNES 2 CO., LTD. DESIGNATIVA DE LAURA CERTIFICAT DE GARANTIE

boso medilife PC3 120 94 66 Gebrauchs- anweisung User Instructions Made d'emploi Manuale di istruzioni Manual del Uzzario 2 39 78 113 150

Quick guide

→Insert batteries, ensure correct positioning (page 48)
→Attach unit (page 55)
When measuring, the wrist must be held at the same height as the heart!
→Start (and stop) a measurement by pressing the 'START' button (page 58)

Measured systolic, diastolic and pulse values are displayed after the measurement is completed (page 60)

→Retrieving values from memory (page 62): with the instrument switched off, press the 'START' button

until the last measurement that has been stored appears in the display (symbol M). Now all the stored measurement readings are shown successively for five seconds. (If no measurements are stored in memory, the systolic, diastolic and pulse readings all show the value '0' for three seconds.) (page 62)

⚠ This quick guide does not replace the detailed information on the use and safety of the blood pressure monitor featured in the user instructions.

Therefore, please ensure rea- ding the user instructions!

Dear Customer,

We are delighted that you have decided to purchase a boso blood pressure monitor. The boso brand is synonymous with optimal quality and precision and is also number 1 among professionals: 77% of all German doctors currently use boso blood pressure monitors (GfK 1/2010).

The experience gained from decades of use by professionals has also been incorporated into all the patient monitors for home measurement.

This instrument has also passed our strict quality control procedures and is your reliable partner for monitoring your blood pressure values.

⚠️ Please read these user instructions before using the instrument for the first time, as correct blood pressure readings can only be obtained if the instrument is operated correctly.

In these user instructions, '→' indicates an action by the user.

To get help concerning usage or maintenance please contact your dealer or the manufacturer (contact details can be found on the back cover of this manual).

Introduction

An unexpected operating condition or an incidence which has worsened the health condition or could have worsened the health condition should be reported to the manufacturer immediately.

If the instrument is to be sold, ensure that these user instructions are enclosed.

If the monitor is used in medical practice (in accordance with the legislation governing the operation of medical devices), it should be calibrated at regular intervals (see page 73).

The boso medilife PC3 blood pressure monitor is suitable for patients of all ages with a wrist circumference of between 13,5 and 21,5 cm. The monitor is not suitable for neonatals.

Wireless communication devices, such as home networking devices, mobile phones, cordless phones and their base stations, walkie-talkies can affect this blood pressure monitor. Therefore, a minimum distance of 11 feet should be kept from such devices.

Blood pressure values

To determine the blood pressure, two values need to be measured:

●Systolic (upper) blood pressure:

This is produced when the heart muscle contracts and blood is forced into the blood vessels.

●Diastolic (lower) blood pressure:

This is present when the heart muscle expands and fills with blood again.

Blood pressure measurement values are expressed in mmHg (mm of mercury).

The World Health Organization (WHO, 1999) has defined the following cut-off values for assessing blood pressure:
	systolic diastolic
High blood pressure over 140 mm Borderline normal blood pressure Normal blood pressure 120 to 129 Optimum blood pressure up to 119	Hg over 90 mmHg 130 to 139 mmHg 85 to mmHg 80 to 84 mmHg mmHg up to 79 mmHg	89 mmHg

Blood pressure values

Whether medical treatment is necessary depends not only on the blood pressure, but also on the patient's risk profile. Please contact your GP if one of the values (systole, diastole) consistently exceeds the cut-off point for high blood pressure.

Self-measurement of blood pressure often produces somewhat lower values at home than at the doctor's.

The German Hypertension League has therefore defined lower cut-off values for home measurements:

Home measurement: 135/85 mmHg

Measurement in the doctor's surgery: 140/90 mmHg

Starting up

The device must be installed and put into operation in accordance with the instructions in this manual.

Illustration 1

→Use only high quality leak-proof batteries of the correct specifications (see 'Technical data' page 70).

⚠️ Never mix old and new batteries or different makes.

⚠️ If the batteries are not inserted correctly, the monitor will not work and this may cause the batteries to heat up and leak, damaging the monitor.

→Inserting the batteries

The battery compartment is located on the upper side of the monitor. Insert batteries in the battery compartment as shown in illustration 1.

→Remove the batteries if the monitor is not to be used for any length of time.

Starting up

The monitor has a battery status display (see page 41)

Battery fully charged.

Replace battery soon.

Flashing! No further measurements possible. Replace battery.

⚠️ Care for the environment

Do not dispose of used batteries and charger units in domestic waste.

You can take these to collection sites for used batteries or special waste.

Contact your local authority for information.

⚠️ Important information on replacing batteries:

After replacement of batteries, please check date and clock settings.

Setting the time and date

Your boso medilife PC3 unit is equipped with an internal time and date function. To set the time and date, press the SET button in the manner described below:

If the SET button is not pressed for approximately 30 seconds, the display returns automatically to its usual time display mode.

SET button 14:1 START Hours : Minutes

Time display mode

↓ press button once and release immediately Date set mode (year flashes)...
→... set the year with the button
↓ press button once and release immediately Date set mode (month flashes)...

Setting the time and date

→... set the month with the button
↓ press button once and release immediately Date set mode (day flashes)...
→... set the day with the button
↓ press button once and release immediately Time set mode (hour flashes)...
→... set the hour with the button

↓ press button once and release immediately Time set mode (minute flashes)...
→... set the minute with the button
↓ press button once and release immediately Time display mode

General instructions for self-measurement

1. Fluctuations in blood pressure are quite normal. Even when measurements are repeated, there can be marked differences. Single or irregular measurements do not provide reliable information about the actual blood pressure. A reliable evaluation is only possible if regular measurements are taken under comparable conditions.

2. ⚠️ Self-testing does not mean self-treatment. Do not on any account change the dose of medicine prescribed by your doctor of your own accord.

3. Irregular heartbeats can affect the accuracy of the monitor or result in incorrect measurements (see page 67).

4. Incorrect measurements can also occur in patients with a weak pulse (possibly in patients wearing a pacemaker, for example). The blood pressure monitor itself has no effect on the pacemaker.
5. If you are pregnant, consult your doctor before using the monitor.

General instructions for self-measurement

1. Always take the measurement in a calm and relaxed state.

You are recommended to check your blood pressure twice a day – in the morning on getting up and in the evening once you have relaxed after work.

1. Always measure your blood pressure from the wrist with the higher blood pressure values (where not required otherwise (see page 56)).

To do this, measure the blood pressure first in both wrists and thereafter always from the wrist with the higher blood pressure.

Preparing to measure your blood pressure

Note on cuff sizes:

The unit must only be used in combination with the CW51 cuff (wrist circumference 13.5 to 21.5 cm).

Observe the following instructions when measuring your blood pressure:

Avoid smoking or drinking coffee for one hour before measuring your blood pressure.

Sit comfortably for the blood pressure measurement.

Support your back and arms. Do not cross your legs. Place your feet flat on the floor.

Relax for 5 minutes before taking a measurement.

Do not move during the measurement.

Preparing to measure your blood pressure

How to wear the unit

The measurement should be taken from the bare wrist.

⚠️ Please make sure the display is positioned at your inner wrist (see illustration 2).

Line drawing of a human hand holding a blood glucose meter (no text or symbols present)

Illustration 2

→Close the cuff with the velcro fastener. The cuff should fit snugly around the wrist. When relaxed, place your elbow on your chest with the wrist in the same height as your heart (see illustration 3).

graph TD
    A["too low values"] --> B["correct values"]
    B --> C["too high values"]
    D["Human silhouette with heart symbol"] -.-> E["Human silhouette with heart symbol"]

Illustration 3

Preparing to measure your blood pressure

⚠️ Do not attach the cuff over wounds as this can cause further injuries.
⚠ Ensure that the cuff is not attached to an arm where arteries or veins are undergoing or have undergone medical treatment (e.g. shunt).
⚠ For women who have had a breast amputated, do not attach the cuff to the wrist on the amputated side of the body.

⚠️ During the measurement, medical apparatus that are being used on the same arm at the same time, may malfunction.
⚠ It can occur that there are differences between measurements at the wrist and the upper arm. Therefore, it is recommended on occasions to take comparative measurements at the upper arm.

Preparing to measure your blood pressure

In cases of poor blood circulation or severe arteriosclerosis, it is not appropriate to take measurements at the wrist. In these instances the blood pressure should be taken at the upper arm.

⚠ When measuring, the wrist must be held at the same height as the heart!

⚠ The blood pressure measurement should not prevent the flow of blood for an unnecessary length of time (>2 minutes). If the monitor fails to function correctly, remove the unit from the wrist.

Excessively frequent measurements can cause injury by restricting blood flow.

Measuring your blood pressure

Your monitor has a memory with a capacity of 280 measurements.

→Start the measurement with the 'START' button

⚠️ Now hold the arm absolutely still and do not talk.

All the items on the LCD display appear briefly to indicate that the monitor is now ready for use (see illustration 4).

M 888 SYS. mm/Hg 888 DIA. mm/Hg ♥ 28:88 (♥) PUL/min

Illustration 4

Measuring your blood pressure

The pump starts to inflate the cuff.

The display indicates the pressure of the cuff as it rises.

The unit inflates to a pressure of about 20 mmHg and then starts the measuring process.

As soon as the unit registers the first beats, the '♥ symbol blinks in time with the pulse rhythm.

⚠️ Interrupting a measurement:

A measurement can be interrupted at any stage by pressing the 'START' button; the cuff deflates automatically.

Measurement display

After the end of the measurement, the inbuilt valve opens automatically and the cuff deflates rapidly.

The measured blood pressure values (systole, diastole, pulse) are displayed (see illustration 5).

SYS. 126 mm/Hg 86 DIA. mm/Hg 89 PUL/min

Illustration 5

The measurement is stored automatically. If the memory store is full (symbol M on the time display mode), the oldest measurement is deleted and the current one stored.

Measurement display

Invalid measurements with an 'Err' message (see page 65) are not stored.

If the symbol ' ' appears after the measurement, it is recommended that the measurement is repeated, holding the arm completely still.

If the ' symbol appears again even with the arm held still, this may be an indication of an irregular heartbeat. Please discuss this with your doctor at your next visit.

Blood pressure is a dynamic parameter and can be affected by the patient's position, e.g. sitting, standing, lying, moving, before or during the measurement as well as by his physical condition (stress, disease, etc.).

→If the measurement result is obviously wrong, repeat the measurement.

The unit switches itself off automatically after about 1 min. To repeat a measurement, press the 'START' button again briefly.

Allow at least two minutes between measurements.

→If no further measurement is required, remove the unit from the wrist.

Recall of stored readings

→You can recall stored readings by switching on the unit and pressing and holding down the START button until the last measurement that has been stored appears in the display (symbol M).

Now all the stored measurement readings are shown successively for five seconds. (If no measurements are stored in memory, the systolic, diastolic and pulse readings all show the value '0' for three seconds.)

→The unit can be switched off by simply pressing the START-button.

If all measurements of the memory have been displayed the unit switches off automatically after 5 seconds.

Erasing the memory

→Press the SET button for approximately five seconds until the M symbol starts to flash. The memory is now erased.

Installation of the boso profile-manager / Data transfer

A comprehensive instruction manual for the boso profile-manager is to be found on the enclosed CD.

For a comprehensive assessment, the content of the memory is to be transferred via the boso profile-manager (enclosed CD) and the enclosed PC-connection cable to a computer. This computer has to comply with the european standard EN 60601-1.

→Connect the boso medilife PC3 with the PC connection cable to the USB port of your PC.

The data transfer mode is activated by inserting the interface cable into the sokket at the back of the unit.

Data transfer

The display indicates nine horizontal lines (see illustration 6).

Pure electrical circuit lines without any symbols

Illustration 6

Attention:

No blood pressure measurement is possible during the data transfer mode.

→After successful data transfer delete the memory by pressing the SET-button until M flashes in the display.

If any problems occur during the measurement, the display will show an error message instead of a blood pressure reading.

Meaning of error messages:

Err1	Cause of Err message	Troubleshooting
	Cuff-pressure varies too much keep arm absolutely still whilst measurement is taken
Err2	No valid pulsations Check positioning of cuff (see page 55) could be obtained and repeat measurement
Err3	Error during inflation Cuff is probably not tight enough, attach cuff more firmly (see page 55)

Error messages

	Cause of Err message	Troubleshooting
	Communication error Repeat transmission
	ROM error Send unit for inspection to the customer service (see page 69)
	Pulse measurement error Repeat measurement
	"♥" Display Troubleshooting
	Irregular pulse or Repeat measurement recommended, movement of arm holding the arm absolutely still. during measurement If the '	' symbol appears again, even with the arm held still, this may be an indication of an irregular heartbeat. Please discuss this with your doctor at your next visit.

Cleaning and Desinfection

Cleaning Monitor:

Use a soft, dry cloth to clean your monitor.

Cleaning Cuff:

Small stains on the cuff can be removed carefully with a proprietary washing-up liquid.

Desinfection:

For disinfectant wipes (at least 5 minutes exposure time) of the device and the cuff, we recommend the disinfectant antifect liquid (Schülke & Mayr). To disinfect the velcro of the cuff, we recommend spray disinfection. In particular, if the device is used on multiple users is to pay attention to regular cleaning and disinfections of the cuff.

Warranty

For details of the warranty conditions, please consult the warranty certificate supplied.

A claim under the warranty will only be accepted if the warranty certificate, completed and stamped by the dealer, is returned with the monitor.

Customer service Disposal

Warranty and repair work must be undertaken by trained and authorised personnel. Do not modify this equipment without authorization of the manufacturer.

Send the monitor, carefully packaged and with sufficient postage, to your authorised dealer or directly to:

Do not dispose of monitors and batteries in the domestic waste.

At the end of its lifespan, the monitor must be taken to a collection site for obsolete electronic items.

Please note that batteries and rechargeable batteries must be disposed of separately (local authority collection site).

Expected operational lifetime of the equipment: 10 years.

Expected operational lifetime of the cuff: 10.000 measurement cycles.

Technical data

Measurement principle: oscillometric

Measurement range: 40 to 255 mmHg, 40 to 180 pulses/min.

Cuff pressure: 0 to 320 mmHg

Memory store: 280 measurements

Display: LCD

Operating conditions: environmental temperature +10°C to +40°C relative humidity 15 to 85%

Storage conditions: environmental temperature -10°C to +60°C relative humidity 15 to 85%

Technical data

Power supply: DC 3 V (4 x 1.5 V Micro IEC LR 03 alkaline manganese batteries)

Typical battery life: 500 measurement cycles (depending on inflation pressure and frequency of use).

Battery check: symbol display in LCD window Weight: 82 g without batteries

Dimensions (WxHxD): 70 mm x 55 mm x 70 mm

Classification: type BF ( )

Protection against solid IP21 objects and water:

Technical data

Clinical test accuracy complies with the requirements (DIN 58130): of EN 1060 Part 3

Maximum deviation of cuff ± 3 mmHg pressure measurement:

Maximum deviation of ±5% pulse rate display:

Applicable standards: EN 1060, Part 1: 'Non-invasive sphygmomanometers – General requirements' and Part 3: 'Supplementary requirements for electro-mechanical blood pressure measuring systems'

(for trained specialist staff only)

Calibration checks – every 2 years at the latest – must be performed by the following institutions or persons:

• Manufacturer
  – Trade measurements authorities
• Persons who fulfil the requirements of the legislation governing the operation of medical devices.

A) Function testing

Function testing of the monitor can only be carried out on a person or with a suitable simulator.

B) Testing of pressure circuit integrity and deviation of pressure display

Note:

a) When the pressure in measurement mode increases above 320 mmHg, the quick release valve is triggered and the pressure circuit opens. When the pressure in test mode increases above 320 mmHg, the measured value display flashes.
b) Prior to testing separate the cuff from the unit. To do so, remove the two connectors with a pointed

Calibration checks - Testing instructions

(for trained specialist staff only)

instrument (i.e. tweezers). The two connectors can be found on the upper and lower side of the unit on each side of the cuff. After removal of the cuff, the air hoses become visible.

c) To perform leak testing of the pressure circuit, T-connectors must be used to connect the rolled-up cuff and a pump bulb to the pressure circuit.

Testing

1. Connect lower hose of the unit with a pressure unit, i.e. pump ball.
2. Open battery compartment for more than 5 seconds. Hold 'START' button pressed down and insert batteries.
3. Release 'START' button.
4. The unit is now ready for testing. The displays of SYS and DIA now show the actual pressure.

Calibration checks - Testing instructions

(for trained specialist staff only)

1. Testing for divergence of pressure indication and density of pressure circuit (setting time for cuff at least 120 seconds) can now be carried out in the usual manner.
2. Switch off unit and reconnect the cuff to the unit.

C) Safety seal

As a safeguard, the upper and lower parts of the housing can be joined with a safety seal. Alternatively, a hole drilled in the bottom of the monitor for the connecting screw for the housing can be sealed for safety.

Table des matières

Coiled black cable with connectors, no visible text or symbols

1 mode d'emploi

boso medilife PC3 120 94 66 Gebrauchs- anierung User Instructions Mode d'emploi Manual di istruzioni Manual del Usario 7 39 76 113 150

Illustration of a human hand holding a blood glucose meter (no text or symbols present)

Figure 2

M 888 SYS. mm/Hg 888 DIA. mm/Hg 38:88 PUL/min

Figure 4

Pure electrical circuit lines without any symbols

Figure 6

Attention :

Coiled black cable with connectors, no visible text or symbols

Line drawing of a human hand holding a blood glucose meter (no text or symbols present)

Fig. 2

M 888 SYS. mm/Hg 888 DIA. mm/Hg 38:88 PUL/min

Fig. 4

boso profile-manager

Pure diagram of a rectangular panel with internal hexagonal and dashed lines, no text or symbols present.

Attenzione:

Coiled black cable with connectors, no visible text or symbols

Line drawing of a human hand holding a blood glucose meter (no text or symbols present)

Figura 2

M 888 SYS. mm/Hg 888 DIA. mm/Hg 38:88 PUL/min

Figura 4

Pure electrical circuit lines without any symbols

figura 6

Atención

Completely blank white image with no visible content, text, or symbols.

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