URION U85E Upper Arm Electronic Blood Pressure Monitor Instruction Manual

U85E Upper Arm Electronic Blood Pressure Monitor

U85E Upper Arm Electronic Blood Pressure Monitor
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 brachia! artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope, so the monitor is simple to use.
• Intelligent inflation will reduce the uncomfortable feeling of 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 a blood classification index, which could easy to check your blood pressure.
• Please read the manual carefully before you use the unit, and keep the manual well after use.

INTENDED USE
This automatic blood pressure monitor intends to measure the systolic pressure, diastolic pressure, and pulse rate through the upper arm. It’s expected to be used at home or in the hospital, intended for people over 12 years old.

Contraindication:
This product can’t be used in patients who is with severe heart insufficiency 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.
CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage.
Type BF applied part
Manufacturer

SN Specifies the serial number
Authorized Representative in the European Community
DISPOSAL: Do not dispose of this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
Direct current
Follow instructions for use

• Those who have an 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 is allowed.
• Do not modify this equipment without the authorization of the manufacturer.
• If this equipment is modified, appropriate Inspection and testing must be conducted to ensure continued safe use of equipment.
• The cuff hose around the neck may cause the suffocation.
• The swallowing of small parts like packaging bags, batteries, battery covers,s and so on may cause 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.
• Do not replace or remove the battery from the device (in the case of a device with a rechargeable lithium battery).
• Do not use a cellular phone near the unit. It may result in operational failure.
• Please avoid using it in the high radiant areas in order to make your measuring data correct.

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.

Classification

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: Continuous operation.

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

Product structure

Body

Display

Cuff size and connection

Battery installation

Remove the battery cover from the battery compartment, insert the battery,

• a) Remove the battery cover as the picture shows.
• b) Insert 4 AAA powerful batteries into the compartment and ensure each battery is in the proper direction.

Low battery and replacement

When powering on, the low battery symbol will display once the unit starts to work, and you must replace it 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 a long time.

WARNING:
Dispose of the battery in accordance with all federal, state, and local laws. To avoid fire and explosion hazards, do not burn or incinerate the battery.

Adapter usage (option)

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 for 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 circuits 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 the 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.

Adapter technical features:
Output voltage: type-c 5V
Output current: At least 600 mA

Setting mode

Note:

• When using an AC adapter, the power of the battery won’ be consumed.
  When suddenly stopping 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:
   

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

3. Month and date setting
   Continue to the above step, the screen will display XXXX and xxxx, and keep flashing on month. the digit will increase by 1 when pressing the button MEM each time, you could choose from 1 to 12. Press the button SET when you confirm the month, then it will set the date. Same as the month setting, each time you press the button MEM, the digit will keep changing from 01 to 31. Press the button SET when you confirm the date, then it will enter into the time setting mode.
   

4. Time setting:
   Continue to the above step, the screen will display XXXX and xx: xx, and keep flashing the digits of the hour, the digit will increase by 1 when pressing the button MEM each time, you could choose from Oto 23. Press the button SET when you confirm the hour, then the digits of the minute start to flash, same as the hour setting, each time you press the button MEM the digits will keep changing from 00 to 59. Press the 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 measurements regularly at the same time of every day, as blood pressure changes even during the day.

Common factors of the wrong measurement

• All efforts by the patient to support their arm can increase blood pressure.
• Make sure you are in a comfortable, relaxed position and do not activate any of the muscles in the measurement arm, don’t legs uncrossed, and keep your feet 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:

• Only use clinically approved cuffs!
• A loose cuff or an exposed bladder causes false reading.
• With repeated measurements, blood accumulates in the arm which can lead to false readings. 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

1. Put the cuff on a table flatly with the velcro side down. Pass the end of the cuff 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 on the arm as illustrated. Make certain that the lower edge of the cuff lies approximately 2 to 3 cm above the elbow and the rubber tube leaves the cuff on the inner side of the arm.
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:

Measuring Procedure:

After the cuff has been appropriately positioned, the measurement can begin as follows:

1. Press the START/STOP button, all symbols appear on the display, then the pump begins to inflate the cuff, and the rising pressure in the cuff is shown on the display.
2. After the suitable pressure has been reached, the pump stops and the pressure gradually falls. The cuff pressure is displayed. In case the inflation is not sufficient, the device automatically re-inflates 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 rates will appear on the display.

Note: The symbol will be displayed along with the reading if an 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 decreases the cuff pressure automatically.

Memory-recall of measurements
This blood pressure monitor automatically stores 2×90 sets of measurements value, the oldest record will be replaced by the latest measurement value when more than 90 sets for each user.

Read memory record
Press the button MEM when power is off, and the latest 3 times average value will be shown, press the button MEM again. the last measurement value will be shown, as well as subsequent measurements can be displayed one after the other by pressing the button MEM each lime.

About blood pressure

Memory -clear of measurements
If you are sure that you want to permanently remove all stored memories. Press the button SET 7 times until CL appears when power is off, press the START/STOP button, and CL will flash 3 times to clear all the memories. After this press, the button MEM, [M], and “no” will be shown on the display which means that no memory is in store.

About blood pressure
Blood pressure is the pressure exerted on the arteries.
The systolic blood pressure value represents the blood pressure produced by the contraction of the heart muscle.
The diastolic blood pressure value represents the blood pressure produced by the relaxation of the heart muscle.

• According to the blood pressure classification by the WHO/ISH.
• SYS lower than 100mmHg (13.3kPa) is considered as hypotension.

• Blood pressure type

Exceptional Situation

Error indicators

• The following symbol will appear on the display when measuring abnormal.

Trouble removal

Care and maintenance

Care for the main unit and blood pressure monitor cuff

Maintenance

Specification

Tempereture:-20°C-55°C; Humidity.10%-93%RH; avoid crash, sun bum or rain during transportation
Expected service ife| Five years
Software version| UA1.0

Warranty information

Statement

• The intended use: the unit is intended to be used by adults at home or a 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 Non-invasive 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 the patient and user can be lowered to an acceptable level. 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 within 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 guarantee 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

IEC 60601-1-2 2014 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for Class B product

Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.

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 ii 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 result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in 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 monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

If any a list of all cables and maximum lengths of cables (if applicable), transducers, and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect the compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).

If any  the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the 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

Table 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 I EC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Compliance

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated
RF IEC61000-4-3 (Test specification ns  for ENCLOSU  RE PORT IMMUNITY to
RF wireless
communications
equipment)| Test
Frequency
(MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Dist arcs (m)| IMMUNO
TY TEST
LEVEL (V/m)
385| 380 -390| TETRA 400| Pulse
modulation
18 Hz| 1,8| 0.3| 27
450| 430 -470| GMRS 460,
FRS460| FM
t 5 kHz
deviation
1 kHz sine| 2| 0.3| 28
710| 704 _ 787| LTE Band 13,
17| Pulse
modulation
217 Hz| 0,2| 0.3| 9
745
—780—
810| 800 -960| GSM 800/900,
TETRA 800,
DEN 820,
CDMA850,
LTE Band 5| Pulse
modulation
18 Hz| 2| 0.3| 28
870
930
1720| 1700-
1990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS| Pulse
modulation
217 Hz| 2| 0.3| 28
1845
1970
2450| 2400 –
2570| Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse
modulation
217 Hz| 2| 0.3| 28
5240| 5100 –
5800| WLAN 802.11
sin| Pulse
modulation
217 Hz| 0,2| 0.3| 9
5500
5785

Smile care
Upper Arm Electronic Blood Pressure Monitor

Manufacturer
Shenzhen Urion Technology Co.,Ltd,
Floor 4-6th of Building D, Jiale Science&Technology Industrial
Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian
Street, GuengMing New District, 518106 Shenzhen, PEOPLE’S
REPUBLIC OF CHINA
Tel: (86)-755-2923
E-mail: urion@urion.com.cn  
MADE IN CHINA

Eu representative
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg,Gennany
Tel:+49-40-2513175

info@konsung.com
www.konsungmedical.com
shholding@hotmail.com

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