ALPHAMED U80N Automatic Upper Arm Blood Pressure Monitor Instruction Manual

ALPHAMED U80N Automatic Upper Arm Blood Pressure Monitor

Introduction

• A 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 by incorrect inflation, and shorten the measurement time, prolong the cuff’s usage lifetime.
• 2×90 sets 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 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 ensure 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.

• 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 that 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 suffocation.
• The swallowing of small parts like packaging bags, batteries, battery covers 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 the product from a high place. Use the right cuff, otherwise it can not work.
• Never leave any low batteries 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 displays a low battery symbol.
• Consecutive blood pressure measurements should be repeated after a 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’t kink 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 PATI ENT due to blood flow interference.
• Don’t apply CUFF over a wound, it can cause further injury to the PATI ENT.
• The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronic 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 if you suffer from illnesses.
• 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 h armful 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 not inflate 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 the 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.

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: intermittent operation.

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

Product structure

Battery installation

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

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

Low battery and replacement
When power on, the low battery symbol 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 by all federal, state and local laws. To avoid fire and explosion hazard, 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 addilional 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 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 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: 6V ± 5%
• Max. output current: At least 600 mA
• Output plug polarity: <+> inner
• External diameter: 5.5mm 0.1 mm
• Internal diameter: 2.1mm 0.1 mm

Setting mode

Note:

• When use AC adapter, the power of the battery won’t be consumed.
• When suddenly stops 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 between  and , press button SET when you confirm the user, then it will enter into the year setting mode.

2. Year setting:
   Continue to above step, the screen will display and flash 20XX, the last digit of the year will increase 1 when press button MEM each time, you could choose from 2001 to 2099. Press 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 slap, the screen will display xxMxxD and xxxx. and keep Hashing on month. the digit will increase 1 when press button MEM each time, you could choose from 1 to 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 to 31. Press 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 xxMxxD and xx:xx, and keep flashing on the digits of hour, the digit will increase 1 when press button MEM each time, you could choose from Oto 23. Press button SET when you confirm the hour, then the digits of minute start to 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 measurements regularly at the same time of every day as blood pressure changes even during the day.

• Common factors of wrong measurement

  • All efforts 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’t have legs 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 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 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

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 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 button, all symbols appear on the display, then the pump begins to inflate the cuff. 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 rate will appear on the display.
5. The measurement readings remain on the display until you switch off the device. If no button is pressed for a period of 3 minutes, the device switches off itself in order to save the power.  

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 decrease the cuff pressure automatically.

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

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 off, press the START/STOP button, CL will flash for 3 times to clear all the memories. After this press button MEM,  and ‘no” will be shown on the display which means that no memory 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

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 81 060-1 Part 1 Noninvasive sphygmomanometers, EN 1 060-3:1997+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.

Warranty Information

• The unit is guaranteed to be free of defects in workmanship and materials under normal use for Two Years from the dale 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 by 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 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 it could result in improper operation. If such use is necessary, his 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 OPERA TOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due lo EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).

Technical description

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

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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, Guang Ming New District, 518106 Shenzhen, PEOPLE’S
REPUBLIC OF CHINA
Tel: ( 86) -755-29231308
E-mail:urion@urion.com.cn
MADE IN CHINA

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

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