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BPB4 BT
EN 1
PL 13
IB BP B4 BT EN-PL 5024
Revision Date: 2024-10-16
CHDE Polska S.A.
Biesiadna 7, 35-304 Rzeszów
Tel. (0-17) 229-37-89
Fax. (0-17) 230-21-14
E-mail: biuro.rzeszow@chde.pl
BDO 000046780
Baterie: zawierają bardzo szkodliwe metale ciężkie
– rtęć, ołów, kadm – które u żywych organizmów
powodują nie tylko poważne zatrucia, ale również
różnego rodzaju upośledzenia w funkcjonowaniu
narządów, przede wszystkim nerek, a nawet całych
układów (pokarmowego, nerwowego i oddechowego).
Bateria, która dostałaby się do organizmu ludzkiego,
mogłaby zabić człowieka w pół godziny. Baterie są
źródłem połowy wszystkich metali ciężkich, które
trafiają do naszego środowiska razem z innymi
śmieciami. Mała guzikowa bateria potrafi zanieczyścić
400 ml wody i 1 metr sześcienny gleby, podczas,
gdy bateria – paluszek – 20 metrów sześciennych.
Dlatego też ważne jest wyrobienie nawyku selektywnej
zbiórki odpadów komunalnych. Pozwala to ograniczyć
negatywny wpływ substancji niebezpiecznych na
środowisko, a także daje drugie życie niektórym
elementom składowym tego rodzaju odpadów. Baterie
wyrzucamy do specjalnych pojemników, ustawionych
w sklepach, galeriach handlowych, urzędach czy
szkołach. Można je także oddać do Punktu Selektywnej
Zbiórki Odpadów Komunalnych (PSZOK).
Ciśnieniomierz automatyczny Bluetooth®
Microlife Corporation
9F, No. 431, RuiGuang Road,
NeiHu, Taipei, 114, Taiwan, China
www.microlife.com
Microlife UAB
P. Lukšio g. 32,
08222 Vilnius
Lithuania
Microlife BP B4 BT Microlife BP B4 BTGuarantee Card
Name of Purchaser / Imię i nazwisko nabywcy
Serial Number / Numer seryjny
Date of Purchase / Data zakupu
Specialist Dealer / Przedstawiciel
Pulse
1Microlife BP B4 BT EN
Display
Dear Customer,
This device was developed in collaboration with physicians and
clinical tests carried out prove its measurement accuracy to be of
a very high standard.*
If you have any questions, problems or want to order spare parts
please contact your local Microlife-Customer Service. Your dealer
or pharmacy will be able to give you the address of the Microlife
dealer in your country. Alternatively, visit the internet at
www.microlife.com where you will find a wealth of invaluable infor-
mation on our products.
Stay healthy – Microlife Corporation!
* This device uses the same measuring technology as the award
winning «BP 3BTO-A» model tested according to the British and
Irish Hypertension Society (BIHS) protocol.
Table of contents
1. Introduction
Document scope
Disclaimers
2. Important information
Device description
Intended use
Intended user
Intended patient
Intended use environment and conditions
Indications
Contra-indications
Side effects
Warning
Caution
Electromagnetic compatibility
Adverse events and reporting
3. Device Information
Device accessories
4. Device installation and setup
Inserting the batteries
Setting the date and time
Selecting the correct cuff
Connecting the cuff to the device
Selecting the user
Selecting standard or MAM mode
5. Measurement preparation
Before taking a measurement
Correct cuff fitting and posture for taking a measurement
6. Measurement operation
Starting measurement
Microlife BP B4 BT EN
1ON/OFF button
2Display
3M-button (memory)
4Bluetooth/MAM button
5User Button
6Cuff socket
7Traffic light indicator
8USB Type-C Adapter Socket
9Battery compartment
AT Cuff
AK Cuff tube
AL Cuff connector
AM Active Bluetooth®
AN Systolic value
AO Diastolic value
AP Pulse rate
AQ Battery display
AR Cuff fit check
-A: Suboptimal cuff fit
-B: Arm movement indicator «Err 2»
-C: Cuff pressure check «Err 3»
AS Cuff signal indicator «Err 1»
BT Irregular heartbeat (IHB) symbol
BK External power source indicator
BL Traffic light display
BM Stored value
BN User indicator
BO MAM Mode
BP Date/Time
BQ Pulse indicator
2
Manual inflation
7. Measurement interpretation
How do I evaluate my blood pressure
Appearance of the irregular heartbeat (IHB) symbol
8. Data memory function
Viewing the average of all stored values
Viewing the stored single values
Clearing all values
How not to store a reading
9. Bluetooth® function operation
Bluetooth® operations
Bluetooth® pairing & app setup
Bluetooth® status
10. Device error and troubleshooting
11. Device maintenance and disposal
Storage
Calibration and support
Disposal
12. Specifications and compliance
Technical specifications
Compliance information
13. Supplement information for users and patients
Guarantee
Symbols and definitions
1. Introduction
Document scope
This document provides important product operation and safety
information regarding this device. Please read this document thor-
oughly before using the device and keep for future reference.
Disclaimers
The Bluetooth® word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks by Micro-
life Corp. is under license. Other trademarks and trade names are
those of their respective owners.
Apple, the Apple logo, iPad, and iPhone are trademarks of Apple
Inc., registered in the U.S. and other countries. App Store is a
service mark of Apple Inc.
Android and Google Play are both trademarks of Google Inc.
The Windows word mark and logos are registered trademarks of
Microsoft Corporation and its affiliated companies.
Microlife® is a registered trademark of Microlife Corporation.
Trademarks and trade names are those of their respective owners.
2. Important information
Device description
A digital home-use blood pressure monitor is a medical device that
utilizes the principles of cuff-based oscillometric method and digital
signal process to compute and provide a blood pressure measure-
ment.
Intended use
This device is intended to measure brachial blood pressures
(systole and diastole) and pulse rate.
Intended user
The device is intended to be operated by adults and adolescents
with adequate vision, motor functions, and education, capable of
understanding the instructions for use and operating general
household electrical appliances.
Intended patient
The intended patients are normotensive and hypertensive adults
and adolescents (aged 12 years or older) of the general popula-
tion.
The intended patients also include those with conditions of
diabetes, pregnancy, pre-eclampsia, atherosclerosis.
Intended use environment and conditions
The device is intended for use in a home healthcare environment
(e.g. general household without medically trained personnel) by
patients (e.g. for self-measurement) or by a care giver.
Indications
This device measures blood pressures for indications of:
Diagnosis of white-coat hypertension and masked hypertension
and identifying white-coat effect and masked uncontrolled
hypertension.
Evaluate blood pressure in response to treatment.
Confirming the diagnosis of resistant hypertension.
Detecting morning hypertension.
Contra-indications
The device is not intended for measuring blood pressure in
pediatric patients of age younger than 12 years old (children,
infant, or neonates).
Read the instructions carefully before using this device.
3Microlife BP B4 BT EN
The device measures blood pressure using a pressured cuff. If
the measuring limb suffers from injuries (for example open
wounds) or under conditions or treatments (for example intrave-
nous drip) making it unsuitable for surface contact or pressur-
ization, do not use the device, to avoid worsening of the injuries
or conditions.
Avoid taking measurements of patients with conditions,
diseases, and susceptible to environment conditions that lead
to incontrollable motions (e.g. trembling or shivering) and
inability to communicate clearly (for example children and
unconscious patients).
The device uses oscillometric method to determine blood pres-
sure and requires the measured limb with normal perfusion.
The device is not intended to be used on a limb with restricted
or impaired blood circulation. Consult with your doctor if you
have severe perfusion or blood disorders before using the
device.
Side effects
In rare cases, slight bruising may result after measurement due to
pressurization of the arm.
Warning
NOTE: Warning items indicate potentially hazardous situations, if
not avoided, may result in death, critical or serious injury to the
user or patient.
Avoid taking measurement on the arm on the side of a mastec-
tomy or lymph node clearance.
Avoid taking measurements on the arm with intravascular
access or therapy or an arterio-venous (A-V) shunt. Cuff and
pressurization may temporarily interfere with blood flow and
could result in injury.
Presence of significant cardiac arrhythmia during measurement
may interfere with blood pressure measurement and affect the
reliability of blood pressure readings. Consult with your doctor
about whether the device is suitable for use in this case.
DO NOT use this device in a moving vehicle (for example in a
car or on an aircraft).
DO NOT use this device for purposes beyond described in this
Instructions for Use. The manufacturer cannot be held liable for
damage caused by incorrect application.
The measurement result of this device is not a medical diag-
nosis and not intended to substitute consultation and diagnosis
by a qualified professional healthcare provider (e.g., physician,
pharmacist, or other licensed health-care professionals).
DO NOT use this device for self-diagnosis or for self-treatment
of a medical condition. Seek advice from a health-care profes-
sional immediately if the patient is clearly unwell and/or having
physiological or medical symptoms.
Inspect the device, cuff, and other parts for damage. DO NOT
USE the device, cuff or parts if they appear damaged or oper-
ating abnormally.
Blood flow of the arm is temporarily interrupted during measure-
ment from cuff pressurization. Extended periods of cuff pressur-
ization reduces peripheral circulation. Beware of signs (e.g
tissue discoloration) of impeded peripheral circulation when
taking prolonged or multiple measurements. It is recommended
to rest between measurements. Abort measurement, loosen
the cuff (or disconnect the cuff and device) and rest to restore
perfusion.
DO NOT use this device in oxygen rich environment or near
flammable gas.
DO NOT use this device with other medical electrical (ME)
equipment simultaneously. This may cause device malfunction
or measurement inaccuracies.
Use and store the device, cuff and parts in temperature
and humidity conditions specified in the «Specifications and
compliance». Usage and storage of the device, cuff and parts
in conditions outside ranges given in the «Specifications and
compliance» may results in device malfunction and the safety
of usage.
Keep the device away from children and people incapable of
operating the device. Beware of the risks of accidental ingestion
of small parts and of strangulation with the cables and tubes of
this device and accessories.
DO NOT let children operate the device alone.
Caution
NOTE: Caution items indicate potentially hazardous situations, if
not avoided, may result in minor or negligible injury to the user or
patient, or damage to the property or environment.