MX HEALTH MX86007 User manual

1
1
TABLE OF CONTENTS
WRIST
BLOOD PRESSURE
MONITOR
USER MANUAL
MODEL: MX86007
Arrythmia
Detecon (IHB)
WHO
BP Indicator
Mul-users
120 Memories
4
HEALTH
MX86007 - IFU - 01.2021.indd 1MX86007 - IFU - 01.2021.indd 1 2021/01/06 13:222021/01/06 13:22

2
3
TABLE OF CONTENTS
IMPORTANT INFORMATION ............................. 3
CONTENTS AND DISPLAY INDICATORS ..................... 4
INTENDED USE ........................................ 4
CONTRAINDICATION ................................... 5
PRODUCT DESCRIPTION ................................ 5
SPECIFICATIONS ....................................... 6
NOTICE .............................................. 7
SETUP AND OPERATING PROCEDURES..................... 10
1. BATTERY LOADING ................................... 10
2. CLOCK AND DATE ADJUSTMENT ........................ 11
3. CONNECTING THE CUFF TO THE MONITOR............... 12
4. APPLYING THE CUFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5. BODY POSTURE DURING MEASUREMENT................ 13
6. TAKING YOUR BLOOD PRESSURE READING ............... 13
7. DISPLAYING STORED RESULTS.......................... 14
8. DELETING MEASUREMENTS FROM THE MEMORY ......... 16
9. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS .......... 16
10. TECHNICAL ALARM DESCRIPTION ..................... 17
11. TROUBLESHOOTING ................................ 18
MAINTENANCE........................................ 19
EXPLANATION OF SYMBOLS ON UNIT ..................... 20
ELECTROMAGNETIC COMPATIBILITY INFORMATION ......... 21
MX86007 - IFU - 01.2021.indd 2MX86007 - IFU - 01.2021.indd 2 2021/01/06 13:222021/01/06 13:22

2
3
IMPORTANT INFORMATION
NORMAL BLOOD PRESSURE FLUCTUATION
All physical acvity, excitement, stress, eang, drinking, smoking,
body posture and many other acvies or factors (including taking
a blood pressure measurement) will inuence blood pressure value.
Because of this, it is mostly unusual to obtain idencal mulple blood
pressure readings.
Blood pressure uctuates connually day and night. The highest
value usually appears in the dayme and lowest one usually at
midnight. Typically, the value begins to increase at around 3:00AM,
and reaches to highest level in the dayme while most people are
awake and acve.
Considering the above informaon, it is recommended that you
measure your blood pressure at approximately the same me each
day.
Measuring too frequently may cause injury due to blood ow
interference. Please always relax for a minimum of
1 to 1.5 minutes between measurements to allow the blood
circulaon in your arm to recover. It is rare that you obtain idencal
blood pressure readings each me.
MX86007 - IFU - 01.2021.indd 3MX86007 - IFU - 01.2021.indd 3 2021/01/06 13:222021/01/06 13:22

4
5
CONTENTS AND DISPLAY INDICATORS
INTENDED USE
This fully Automac Electronic Blood Pressure Monitor is for use by medical
professionals or at home to measure the diastolic and systolic blood pressures
and pulse rate of an adult individual by using a non-invasive technique in which
an inatable cu is wrapped around the wrist. The cu circumference is limited
to 14cm-19.5cm (approx. 5 1/2"-7 11/16").
Low Baery
Group Symbol
Release Air Symbol
Blood Pressure Level
Classicaon Indicator
Irregular Heartbeat Symbol
"START/STOP" Buon
"MEMORY" Buon
Cu
MX86007 - IFU - 01.2021.indd 4MX86007 - IFU - 01.2021.indd 4 2021/01/06 13:222021/01/06 13:22

4
5
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this Electronic
Sphygmomanometer.
PACKAGE CONTENTS
1 Blood Pressure Monitor With Aached Wrist Cu
1 Operaon Guide
1 Plasc Bag
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor,
blood pressure and pulse rate can be measured automacally and non-
invasively. The screen will show blood pressure and pulse rate. The most recent
4×30 measurements can be stored in the memory with date and me stamp.The
Electronic Sphygmomanometers corresponds to the below standards: IEC 60601-
1:2005 +A1:2012(E)/EN 60601-1:2006/A11: 2013 (Medical electrical equipment
-- Part 1: General requirements for basic safety and essenal performance),
IEC60601-1-2:2014/EN60601-1-2:2015 (Medical electrical equipment -- Part 1-2:
General requirements for basic safety and essenal performance - Collateral
standard: Electromagnec compability - Requirements and tests), IEC80601-
2-30:2009+AMD1:2013/EN 80601-2-30:2010/A1:2015(Medical electrical
equipment –Part 2-30: Parcular requirements for the basic safety and essenal
performance of automated non-invasive sphygmomanometers)EN 1060-1: 1995
+ A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements),
EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems). ISO81060-2 : 2013 (Non-Invasive Sphygmomanometers - Part 2: Clinical
Validaon Of Automated Measurement Type).
CONTENTS AND DISPLAY INDICATORS
Low Baery
Group Symbol
Release Air Symbol
Blood Pressure Level
Classicaon Indicator
Irregular Heartbeat Symbol
MX86007 - IFU - 01.2021.indd 5MX86007 - IFU - 01.2021.indd 5 2021/01/06 13:222021/01/06 13:22

6
7
SPECIFICATIONS
1. Product name: mx™ Wrist Blood Pressure Monitor
2. Model: MX86007
3. Classicaon: Internally powered, Type BF applied part,IP22,No AP
or APG,Connuous operaon
4. Machine size: Approx. 89mm x 60mm x 31mm
5. Cu circumference: 14cm - 19.5cm(5 1/2" - 7 11/16")
6. Weight: Approx. 69g (2 3/8oz.) (exclude baeries and cu)
7. Measuring method: Oscillometric method, automac inaon and
measurement
8. Memory volume: 4×30 mes with me and date stamp
9. Power source: baeries: 2 ×1.5V SIZE AAA
10. Measurement range:
Cu pressure: 0-300mmHg
Systolic: ......60-260mmHg
Diastolic:.....40-199mmHg
Pulse rate: ..40-180 beats/minute
11. Accuracy:
Pressure: ±3mmHg
Pulse rate: Less than 60: ±3bpm
More than 60 (incl.) : ±5%
Precision of the displayed values: 1mmHg
12. Environmental temperature for operaon: 10°C - 40°C(50°F - 104°F)
13. Environmental humidity for operaon: ≤85%RH
14. Environmental temperature for storage and transport: -20°C- 50°C
(-4°F - 122°F)
15. Environmental humidity for storage and transport: ≤85%RH
16. Environmental pressure: 80kPa-105kPa
17. Baery life: Approx 200 mes.
18. All components belonging to the pressure measuring system,
including: Pump, Valve, Screen, Cu, Sensor
Note: These specicaons are subject to change without noce.
MX86007 - IFU - 01.2021.indd 6MX86007 - IFU - 01.2021.indd 6 2021/01/06 13:222021/01/06 13:22

6
7
NOTICE
1. Read all of the informaon in the operaon guide and any other
literature in the box before operang the unit.
2. Stay sll, calm and rest for 5 minutes before blood pressure measurement.
3. The cu should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measure on the same wrist for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements to
allow the blood circulaon in your arm to recover. Prolonged over-inaon
(cu pressure exceed 300 mmHg or maintained above15 mmHg for longer
than 3 minutes) of the bladder may cause ecchymoma of your arm.
7. Consult your physician if you have any doubt about below cases:
1) The applicaon of the cu over a wound or inammaon diseases;
2) The applicaon of the cu on any limb where intravascular access or
therapy, or an arterio-venous (A-V) shunt, is present;
3) The applicaon of the cu on the arm on the side of a mastectomy or
lymph node clearance;
4) Simultaneously used with other monitoring medical equipments on the
same limb;
5) Need to check the blood circulaon of the user.
8. This Electronic Sphygmomanometers is designed for adults and should
never be used on infants or young children. Consult your physician or other
health care professionals before use on older children.
9. Do not use this unit in a moving vehicle, this may result in erroneous
measurements.
10. Blood pressure measurements determined by this monitor are equivalent to
those obtained by a trained observer using the cu stethoscope
auscultaon method, within the limits prescribed by the American Naonal
Standard Instute, Electronic or automated sphygmomanometers.
11. Informaon regarding potenal electromagnec or other interference
between the blood pressure monitor and other devices together with advice
regarding avoidance of such interference please see part
ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the
MX86007 - IFU - 01.2021.indd 7MX86007 - IFU - 01.2021.indd 7 2021/01/06 13:222021/01/06 13:22

8
9
blood pressure monitor be kept 30 cm away from other wireless devices,
such as WLAN unit, cell phone, microwave oven, etc. It can’t be used near
acve HF SURGICAL EQUIPMENT and the RF shielded room of an
ME SYSTEM for magnecresonance imaging, where the intensity of EM
DISTURBANCES is high.
12. If Irregular Heartbeat (IHB) brought on by common arrhythmias is detected
in the procedure of blood pressure measurement, a signal of will be
displayed. Under this condion, the Electronic Sphygmomanometer can
keep funcon, but the results may not be accurate, it’s suggested that you
consult with your physician for accurate assessment.
There are 2 condions under which the signal of IHB will be
displayed:
1) The coecient of variaon (CV) of pulse period >25%.
2) The dierence of adjacent pulse period ≥0.14s, and the number of such
pulse takes more than 53 percentage of the total number of pulse.
13. Please do not use a cu other than supplied by the manufacturer, otherwise
it may bring biocompable hazard and might result in measurement errors.
14. The monitor might not meet its performance specicaons or cause safety
hazard if stored or used outside the specied temperature and humidity
ranges in specicaons.
15. Please do not share the cu with other infecve person to avoid cross
infecon.
16. This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protecon against harmful interference in a
residenal installaon. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the
instrucons, may cause harmful interference to radio communicaons.
However, there is no guarantee that interference will not occur in a
parcular installaon. If this equipment does cause harmful interference to
radio or television recepon, which can be determined by turning the
equipment o and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
— Reorient or relocate the receiving antenna.
MX86007 - IFU - 01.2021.indd 8MX86007 - IFU - 01.2021.indd 8 2021/01/06 13:222021/01/06 13:22

8
9
— Increase the separaon between the equipment and receiver.
— Connect the equipment into an outlet on a circuit dierent from that to
which the receiver is connected.
— Consult the dealer or an experienced radio/TV technician for help.
17. This device complies with part 15 of the FCC Rules. Operaon is subject to
the following two condions:
1) This device may not cause harmful interference, and
2) this device must accept any interference received, including interference
that may cause undesired operaon.
18. Measurements are not possible in paents with a high frequency of
arrhythmias.
19. The device is not intended for use on neonates, children or pregnant
women. (Clinical tesng has not been conducted on neonates, children or
pregnant women.)
20. Moon, trembling, shivering may aect the measurement reading.
21. The device would not apply to the paents with poor peripheral circulaon,
noceably low blood pressure, or low body temperature (there will be low
blood ow to the measurement posion).
22. The device would not apply to the paents who use an arcial heart and
lung (there will be no pulse).
23. Consult your physician before using the device for any of the following
condions: common arrhythmias such as atrial or ventricular premature
beats or atrial brillaon, arterial sclerosis, poor perfusion, diabetes, pre
eclampsia, renal diseases.
24. The paent is an intended operator.
25. Aenon that changes or modicaon not expressly approved by the
party responsible for compliance could void the user’s authority to operate
the equipment.
26. Swallowing baeries and/or baery uid can be extremely dangerous. Keep
the baeries and the unit out of the reach of children and disabled persons.
27. If you are allergic to plasc/rubber, please don’t use this device.
MX86007 - IFU - 01.2021.indd 9MX86007 - IFU - 01.2021.indd 9 2021/01/06 13:222021/01/06 13:22

10
11
SETUP AND OPERATING PROCEDURES
BATTERY LOADING
a. Open baery cover at the back of the monitor.
b. Load two “AAA” size baeries. Please pay aenon to polarity.
c. Close the baery cover.
• When the screen shows the baery symbol replace all baeries
with new ones.
• Rechargeable baeries are not suitable for this monitor.
• Remove the baeries if the monitor will not be used for a
month or more to avoid relevant damage of baery leakage.
• Avoid the baery uid geng into your eyes. If it should get
in your eyes, immediately rinse with plenty of clean water and contact
a physician.
The negave terminal of the baery needs to be compressed into the
baery compartment properly aer horizontal compression of the
negave electrode. The baery is in contact with the spring.
Make sure the baery cover is intact and not damaged before installing
the baery.
The monitor, the baeries and the cu, must be disposed of according to
local regulaons at the end of their usage.
2. CLOCK AND DATE ADJUSTMENT
a. At rst the Blood Pressure Monitor is totally o, once you insert
the baery, the Blood Pressure Monitor will enter Clock and Date
Adjustment Mode.
b. If the me of the device is already set and needs to be changed,
adjustment can be reached by pressing the “START/STOP” and “MEM”
buon for 5 seconds in Standby Mode.
c. In Clock and Date Adjustment Mode , the me format will blink at
rst, see picture2-1.
MX86007 - IFU - 01.2021.indd 10MX86007 - IFU - 01.2021.indd 10 2021/01/06 13:222021/01/06 13:22