AQESO U80Y Blood Pressure Machine Upper Arm Instruction Manual

Upper Arm Electronic
Blood Pressure Monitor
Model:U80Y Instruction Manual

Introduction

• Your new digital blood pressure monitor uses the oscillometric method of blood pressure measurement. This means the monitor detects your blood’s movement through your brachial artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope, so the monitor is simple to use.
• Intelligentinflation will reduce the uncomfortable feeling by incorrect inflation, and shorten the measurement time, prolong the cuff’s usage lifetime.
• 2x500sets memory function, each measurement result will be displayed on the screen, and automatically stored .This unit has blood classification index, could easy to check your blood pressure.
• Please read the manual carefully before you use the unit, and keep the manual well after using.

INTENDED USE
This automatic blood pressure monitor intends to measure the systolic pressure, diastolic pressure and pulse rate through upper arm. It’s expected to be used athome or in the hospital, intended for people over 12 years old.
Contraindication:
This product can’t be used in patients who is with severe heartinsufficiency to avoid suffocation and death This product is not suitable for infants and children

Safety Information

To assure the correct use of the product, basic safety measures should always be followed including the warning and the caution listed in the instruction manual :
Symbol descriptions
The following symbols may appear in this manual, on the label, on the device, or on it’s accessories. Some of the symbols represent standards and compliances associated with the device and its use

**| WARNING: This alert identifies hazards that may cause serious personal injury or death.
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| CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage:
**| Type BF applied part
| Manufacturer
| Specifies serial number
| Authorized Representative in the European Community
| CE Mark: conforms to essential requirements of the ” Medical Device Directive 93/42/EEC.
| DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
| Directcurrent
| Follow instructions for use
**| CAUTION:** Consult accompanying documents

Those who have arrhythmia, diabetes, blood circulation or apoplexy problem, please use under the physician’ s instruction
Contact your physician for specific information about your blood pressure. Self diagnosis and treatment which Use measured results may be dangerous. Follow the instructions of your physician or licensed healthcare provider.
Please place on a high place where children can’ t be touched
No modification of this equipment s allowed
Do not modify this equipment without authorization of the. manufacturer.
this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.
The cuff hose around neck may cause the suffocation.
The swallowing of small part like packaging bag, battery, battery cover and so on may cause the suffocation.
Please don’t use a dilution agent, alcohol or petrol to clean the unit. Please don’t hit heavily or fall down the product from a high place. Use the right cuff, otherwise it can not work.
Never leave any low battery in the battery compartment since they may leak and cause damage to the unit
Please take off the battery if you won’t use in 3 months.
Replace the new batteries if the unit display a low battery symbol
Consecutive blood pressure measurements should be repeated after 1 minute pause or after the arm has been held up in order to allow the accumulated blood to flow away.
If the arm circumference size is beyond the measuring range of CUFF it can’t be measured and used ,then it will cause the blood flowing unsmooth and wrong measurement data
Don’tkink the connection tube during use, otherwise the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.
Too frequent measurements can cause injury to the PATIENT ‘due to blood flow interference.
Don’t apply CUFF over a wound, it can cause further injury to the PATIENT.
The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit f you suffer from ilinesses.
When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent :the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.
Do notinflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those.
Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
Do not mix the old and new batteries.
Do not use a cellular phone near the unit. It may result in operational failure.
Please avoid using in high radiant area in order to make your measuring data correctly.
** Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are present
WARNING:
** Do not dispose of electrical appliances as unsorted municipal waste, use separate collection facilities.
Contact you local government for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being.
Classlficallon

1. Internally powered equipment;
2. Type BF applied part;
3. Protection against ingress of water or Particulate matter IP21
4. Not category AP /APG equipment;
5. Mode of operation: Intermttent operation.

**** The user must check that the equipment functions safely and see that it is in proper working condition before being used.

Product structure

Cuff size and connection
The blood pressure monitor UBOY can be compatible with upper arm cuffs both large size (L) and extra-large size(XL). L size fits arm circumference ranged from 22 to 42 cm (9-17 IN) and XL size fits 32-52 cm (13-21 IN).

Battery installation

Battery installation
Remove the battery cover from the battery compartment, insert the battery,
a)Remove the battery cover as picture showed.
b)Insert 4 AAA powerful batteries into the compartment and ensure each battery is inthe proper direction
Low battery and replacement
When power on. the low battery symbol <=1 will display once the unit start to work, and you must replace with new batteries, otherwise the unit can’ t work
Battery type and replacement
Please use 4pcs AAA identical 1. 5V alkaline batteries.
Do not use the batteries beyond their expiry date.
Please remove the batteries if you do not need to use for long time.
WARNING:
Dispose of the battery in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.
Adapter Usage (USB C Power Adapter not included other than USB Type-C cable, AC Adapter’s technical speciation requirement is described in this page)

1. When optional AC adapter should comply with the requirement of IEC 60601-1:2005. Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department.
2. This device is double insulated and protected against short circuit and overload by a primary thermal fuse. Make sure to take the batteries out of the compartment before using the mains part. Equipment class 2
3.  When using AC power, to avoid possible damage to the monitor, use only the exclusive AC adapter that can be purchased from authorized dealers. Other adapters may vary in output voltage and polarities.
4. Insert the adapter plug into the hole on the backside of the unit as picture.
5. Insert the other side of the adapter into the outlet. with 100-240V.
6. To remove the AC adapter, disconnect the adapter plug from the outlet first and then disconnect the cord from the unit’s socket.

USB C Power Adapter Technical Specification: Input: AC 110-240V.
Input voltage frequency: 50-60Hz.
Output: DC 5V
Interface output: USB C output
Output voltage adjustment rate: 5%.
Rated output current > 600mA

Setting mode

Note

• When use AC adapter, the power of battery won’t be consumed
• When suddenly stop during measurement (like the plug off from the outlet by carelessness). it must be reinserted the plug into the unit, and restart the measurement.

How to set

1. User setting
   Press button SET when power off , the screen will display or press button MEM it will be changed and between press button SET when you confirm the user, then it will enter into the year seting mode.

2. Year setting:
   Continue to above step, the screen will display and flash 20XX, the last digit of the year will increase 1when press button MEM each time, you could choose from 2020 to 2099, Press button SET when you confirm the year, then itwill enter into the month and date setting mode.

3. Month and date setting
   Continue to above step, the screen will display xxMxxD and xxxx, and keep flashing on month . the digit will increase 1 when press button MEM each time, you could choose from 110 12. Press button SET when you confirm the month, then it will set the date. Same as the month setting , each time you press button MEM . the digit will keep changing from 01 1031, Press button SET when you confirm the date, then it will enter into the time setting mode.

4. Time setting
   Continue to above step, the screen will display xxMxxD and xx:xx, and keep flashing on the digits of hour, the digit will increase 1 when press button MEM eachtime, you could choose from 0to 23, Press bution SET when you confirm the hour, then the digits of minute startto flash , same as the hour setting . each time you press button MEM the digits will keep changing from 00 to 59. Press button SET when you confirm the minute, then the total setting mode is completed.

Proper use of the unit

Measurement
Pre-measurement

• Relax for about five to ten minutes prior to the measurement Avoid eating, drinking alcohol, smoking, exercising and bathing for 30 minutes before taking a measurement All these factors will influence the measurement result.
• Remove any garment that fits closely to your upper arm
• Always measure on the same arm(normally left)
• Take measurement regularly at the same time of every day,as blood pressure changes even during the day.

Common factors of wrong measurement

• Allefforts by the patient to support their arm can increase blood pressure.
• Make sure you are in a comfortable, relax position and do not activate any of the muscles in the measurement arm . don’tlegs uncrossed keep the feel flat on floor, back and arm supported during measurement. Use a cushion for support if necessary.
• If the arm artery lies lower or higher than the heart,a false reading will be obtained.

Note

• Please only use cuffs certified by AQESO brand. Using cuffs from other brands may reslt in inaccurate measurement.
• Aloose cuffor a exposed bladder causes false reading
• With repeated measurements, blood accumulates in the arm which can lead to false reading

Consecutive blood pressure measurements should be repeated after 1 minute pause or after the arm has been held up in order to allow the accumulated blood to flow away.
Fitting the cuff (22-42cm and 32-52cm cuff are optional)

1. Put the cuff on a table flatly with the velcro side down. Pass the end of the cuf through the metal loop so that a circle is formed. The velcro closer will now be facing outwards (ignore this step if the cuff has already been prepared)

2. Push the cuff over the left upper arm so that the tube points in the direction of the lower arm.

3. Wrap the cuff around the arm as shown in the picture. Make sure that the distance between the cuff trachea turret and the elbow joint is about 2-3cm.

4. Tighten the free end of the cuff and close the cuff by affixing the velcro.
   

5. The cuff should be snug on your upper arm so That you can fit 2 fingers between the cuff and your upper arm. Any piece of clothing restricts the arm which must be taken off

6. Secure the cuff with the velcro closer in such a way that it lies comfortably and not too tight. Lay your arm on a table (palm upwards) so that the cuff is at the same height as the heart. Do not bend the tube.
   

Note:
If it is not possible to fit the cuff to your left arm, it can also be placed on the right. However. all measurements should be made using the same arm.

Measuring procedure
After the cuff has been appropriately positioned.the measurement can begin

1. Press the START/STOP buttan, al symbols appear on the display , then the pump begins to nflate the culf, the  rising pressure in the cuff s shown on the dispiay.

2. After the suitable pressure has been reached the pump stops and the pressure gradually fals. The cuff prossure i displayed In case that the inflation s not fonsuficient the device automaically re-inlates to a higher pressure.

3. When the device detects the signal, the heart  symbol on the display starts to flash.

4. When the measurement has been completed, the systolic,diastolic and pulse rate will appear onthe display.

5. The measurement readings remain on the display until you switch off the device.If no button is pressed for aperiod of 3 minutes, the device switches offitselfin order to save the power.

Note:The symbol will be displayed along with the reading if the irregular heartbeat is detected during the measurement
Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason (eg. the patient feels unwell) the START/STOP button can be pressed at any time. The device immediately decrease the cuff prassure automatically.
Memory-recall of measurements
This blood pressure monitor automatically stores 2×500 sets measurements value, the oldest record will be replaced by the latest measurement value when more than 500 sets each user.

About blood pressure

Memory -clear of measurements
If you are sure that you want to permanently remove all stored memories. Press the button SET for 7 times until CL appears when power of,press the START/STOP button .CL willflash for 3 imes to lear all the memories. Afte this press button MEM, and “no” will be shown on the display which mean that no memory in store.
About blood pressure
Blood pressure s the pressure exerted the arteries
The systolic blood pressure value represents the blood pressure produced by contraction of the heart muscle.
The diastolic blood pressure value represents the blood pressure produced by relaxation of the heart muscle.
Systolic blood pressure Diastolic blood pressure

• According to the blood pressure classification by the WHO/ISH
• WSYS lower than 100mmHg is considered as hypotension
• Blood pressure type

Exceptional Situation

Error indicators
WThe following symbol wil appear on the display when measuring abnormal.

With a correct way.
| External strong disturbance| When near cell phone or other high radiant device . the measurement will be failed
Keep quite and no chatting when measure
| It appears error during the process of inflating| Wrap the cuff properly.
Make sure that the air plug is properly inserted in the unit.
Remeasure.
| Abnormal
blood pressure| Repeat the measurement after relax for 30 mins . if get unusual readings for 3 timesiplease contact your doctor
| Low battery| Replace all the worn batteries with new ones.

Trouble removal

polarities
No inflation| Whether the plug insert| Insert into the air socket tightly
Whether the plug broken or leak| Change a new cuff
Err and stop ‘Id Orcng| ‘Whether move the arm when inflate| Keep the body peaceful
Check if chatting when measured| Keep quite when measure
Cuff leak| Whether the cuff wrap too loose| Wrap the cuff tightly
Whether the cuff broken| Change a new cuff
**** Please contact the distributor if you can’ t solve the problem. do not disassemble the unit by yourself’

Care and maintenance

Care for the main unit and blood pressure monitor cuff

• Keap the unitn the storage case when

• Claan the unit with soft dry cloth. D0 not use any abrasive or volatle cleaners.

• Never immerse the unitor any componentin water.

• Make sure the monitor s off prior 1o leaning a mixture of istled water and 10 percent bleach could be used

• Using a spray botile, moisten a soft cloth owl with the bleach or detergent mix until s fully saturated. Squeeze any excess moisture rom the cloth to avoid any dripping or potential oversaturation of the cut.

• Wige all surtaces of the blood pressure monitor cuffthoroughly, making sure to clean the inside and outside of the cuf. Be cautious not t0 get any moisture in the main unit.

• Using a dry cloth, gently wipe away any excess moisture that may remain on the blood pressure cufl. Lay the cuffflatn an unrolled position and allow the cuff to air dry.

Maintenace

• D0 not ciean the body and cuff with naphina,thinner or gasoine etc.
• Do ot wat the cuff or attempt to clean fhe cuf with water.
• Store the unitin & clean and dry location Do not subject the unit to extreme hot or cold temperature, humidity and direct sunlight.
• Removs the batieres the unt wil ot be used in 3 monihs or longer.

We won’t be responsible for any quality problem if you don’t care and maintain the product s instructed.

Specification

crash, sun burn or rainduring transportation.
Expected service life| 5 years
Software Ver| UA1.0

Warranty information

Statement

• The intended use: the unit is intended to be used by adults at home or medical center to measure blood pressure and pulse rate from the upper arm.
• The unit satisfies the requirements of EN ISO 81060-1 Part 1 Noninvasive sphygmomanometers, EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers. IEC80601-2-30 Part 2 Non-invasive sphygmomanometers
• Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, manual electronic, or automated sphygmomanometers.
• The risk of patient and user can be lowered to acceptable level

Warranty Information

• The unit is guaranteed to be free of defects in workmanship and materials under normal use for a period of Two Years from the date listed on the purchase record
• For repair under this warranty. Our authorized service agent must be advised of the fault with the period of the warranty. This warranty covers parts and labor only under normal operations. Any defect resulting from natural causes, eg. flood, hurricane etc. is not within this guarantee. This guaranty does not cover damage incurred
• By use of the unit not in accordance with the instructions, accidental damage. or being tampered with or serviced by unauthorized service agents.
• Monitor subjected to misuse, abuse, and neglect of these manual content . non-instructional purposes: unauthorized repair or modifications will be excluded from this warranty.
  The device requires no calibration.
  The device is not repairable and contains no user serviceable parts

EMC Declaration

EC 60601-1-2: 2014 ME EQUIPMENT and ME SYSTEMS identfication, marking and documents for Class B product
Instructions for use
The ME EQUIPMENT or ME SYSTEM is sutable for home healthcare environments and soon
Warning: Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could resut in increased electromagnetic emissions or decreased electromagnetic immunity of tis equipment and resutin improper operation.”
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the blood pressure monilor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result
Ifany: alistof all cables and maximum lengths of cables (f applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY).
ACCESSORIES may be specified sither generically (e.g. shielded cable, load impedance) or specifcally (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE)
1f any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined 1o be ESSENTIAL PERFORMANCE and a description of wha the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (ihe defined term “ESSENTIAL PERFORMANCE” need not be used)
Technical description

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity.

Tabe 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| Group 1
RF emissions CISPR 11| Class B
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Compliance

Tabe 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4.2| 18 kV contact
t2 kV. 14 kV. ill kV, 115 kV as| 18 kV contactv ±2 kV. ±4 kV. ±13 kV. ±15 kV air
Elecfrical fast transient/burst IEC 610004.4| Power supply lines 12 kV 100 kHz repetition frequency| Power supply lines ±2 kV 100 kHz repetition frequency
Surge
IEC 610004-5| ine(s) to Inlets): 10.51(V t1 kV| line(s) to bne(s)-
10.5kV t1 kV
Voltage dips. short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| 0% 0.5 cycle At 0°, 45°, 90 °.
135 °. 180 °, 225°. 270 ° and 316° 0% 1 cycle And
70% 25/30 cycles Single phase: at 0 0% 300 cycle| 0% 0.5 cycle At 0°.45 °, 90 °
135 •, 180 °, 225 °. 270 ° and 315.0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle
Power frequency magnetic field IEC 61000-4.8| 30 A/rn 50Hz/6014z| 30 Ahn 50Hz/60Hz
Conduced RF
IEC61000-4.6| 150KHz to SOMHz
3Vrms
6Vrms (in ISM and amateur radio bands)
80%Am at 1kHz| 150101z to 80MHZ.
3Vnns
6Vrms (Si ISM and amateur radio bands)
80%Am at 1kHz
Radiated RF IEC61000-4-3| 10 Vhn
80 MHz – 2.7 Gliz
80%AM at 1 kHz| 10 Vhn
SO wiz -2.7 GHz
80 %AM at1 kHz
NOTE UT is the a.c miens vol age prior to application of the test level.

Tabe 3

Documents / Resources

| AQESO U80Y Blood Pressure Machine Upper Arm [pdf] Instruction Manual
U80Y, U80Y Blood Pressure Machine Upper Arm, Blood Pressure Machine Upper Arm, Pressure Machine Upper Arm, Machine Upper Arm, Upper Arm, Arm
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