Upper Arm Electronic

BLOOD PRESSURE MONITOR

Model:U8OM

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.
♦ Intelligent inflation will reduce the uncomfortable feeling by incorrect inflation, and shorten the measurement time. prolong the cuffs usage lifetime.

♦ 2×90 sets memory function each measurement result will be displayed on the screen, and automatically stored This unit has blood classificaton index, could easy to died< your 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.

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.

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.

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
Class II equipment
Manufacturer
SN 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.
Direct current
Follow instructions for use

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. Sell 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 authorisation 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 neck may cause the suffocation.

The swallowing of small park like packing bag. battery. battery cover and on may cause the suffocation. a,

Please don’t use a dilution agent. alcohol or petrol to clean the unit. Please don’t hit heavily or tall down the product prom a high place. Use the right cutl. 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.

Do not mix the old and new batteries.

Do not use a cellular phone near the unit. It may result on 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 anestheticgas. oxygen or hydrogen) or flammable liquid such as alcohol) are present.

Do not touch the output of AC adapter and the patient simultaneously.

Do not touch the live and of battery and the patient simultaneously when change the batteries.

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 Of dumps. hazardous substances can leak into the groundwater                                and gat into the food chain, damaging your health and wellbeing.

Classification

1. Internally powered equipment:
2. Type 5IF 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

Body

Display

Cuff size and connection

The accessories cuff is L size. for upper-arm circumference 8.66′ to 16.5″ use. The cuff is treated as the applied part.

(Only provided cuff can be used. can not change to any other branded cuff.)

Battery installation

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

• Remove the battery cover as picture showed.
• lnsert 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 in accordance with 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 el IEC 60601-1-2005. Furthermore all configurations Shall Comply with the requirements for medical °leanest systems (see IEC 60601.1-1 or clause 16 of the 3Ed el IEC 6060-1-1. 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 Ian that localizes take priority over the above mentioned requirements. II in doubt. consult your focal representative or the technical service department.
2. When using AC power to ovoid possible damage to the monitor , use only thou exclusive AC adapter can be purchased from authorised dealer  Other adapter may very in output wattage and Polarities
3. Insert the adapter plug into the hob on the backside or the unit as picture.
4. Insert the other side of the Wept.* into the Outlet with 100.240V.
5. To remove the AC adapter. disconnect Pm adaptor plug from the collet fast and then disconnect the cord I COT the units Socket

Adapter technical features:

Output votlage:6v +5% Max. Output current atleast 600 mA.

Output plug polarity: <+> inner

External diameter 4.5mm 0.1mm

Internal diameter 1.6mm 0.1 mm

Setting mode

Note

• Men use AC adapter. the power of battery won’t be consumed.

• When suddenly stop Owing measurement( like the plug off from the outlet by carelessness). It must be Smarted the plug Into the unit. and restart the measurement.

How to set

User setting:

Press button SET when power oil . the screen will display    . press button MEM .it will be changed between . press button  SET when you confirm the user. Men it will enter into the year selling made.

Year setting:

Cc venue to above step. the screen will Meekly and Rash 20XX. the last digit al the year will increase I when press button MEM each Wee. you Ceuta Choose from 2001102099. Pens butler. SET when you confirm the year. then II will enter kilo the month and date setting mode.

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 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.

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 each time, you could choose from 0 to 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.

Measurement

Pre-measurement

Proper use of the unit

• Please keep quiet for 5. 10 minutes. and avoid eating, drinking alcohol. smoking. exercising and bathing before taking measurement. All these factors will influence the measurement Inuit
• Remove any garment that fits closely to your upper arm.
• Always measure on the same armjnorrnally left).
• Take measurement 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 comfrotable. relax position and do not activate any of Me muscles In the measurement arm during measurement. Use a cushion for support if necessary.
• If the arm artery lies lower or higher than the hearts false reading will be Obtained. Note.
• Only use clinically approved cuffs!
• Moose cuff or a exposed bladder causes false reading.
• With repealed measurements blood accumulates in Me arm which can lead to false reading. Consecutive blood pressure measurements should be repealed after I 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 be velcro side down. pass the end of the cuff  through the metal loop so that  Circle is formed. The velcro closer will now be facing  outward (ignore this Step d the cuff has already been vectored)
2. Push the cuff over me left upper arm.
3. ‘wrap the cuff on the arm as illustrated Make certain that the lower edge of the cuff, lies  approximately 2 M 3 cm  (about 1 inch). above the elbow
4. Tighten the free end of the cuff end close the Cuff by affixing the velcro
5.  The cull should be snug on your upper arm so That you can fit 2 fingers between the sun and your upper arm Any piece of cloth restricts the arm which must be taken off
6. Secure the cuff wan the velcro closer in such a way that it lies comfortably and not too bight, lay your arm on a table. (palm upwards)’ so that the cuff is at the same height as the heart

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

Measuring procedure:

After the cuff he. been appropriately positioned. the measurement can begin.

1. Press the STARTISTOP sullen. all symbols appear on the display. than 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 that the inflation is not sufficient. the device automatically re-Inflates to a higher pressure.
3. When the device detects the signal. the been symbol on the display starts to flash.
4. When the measurement bee been completed. the systolic. diastolic and pulse rate will appear on the &splay
5. The measurement readings remain on the display un till you switch on the device. If no button is pressed for a period of 3 minutes. the device switches of itself in order to save the power

Discontinuing a measurement

If it is necessary to interrupt a brood pressure measurement or any reason (eg. the patient feels unwell) the START/STOP button can be messed al any time. The device immediately decrease the cuff pressure automatically.

Memory-recall of measurements

This blood pressure monitor automatically stores 2×90 sets measurements value, 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 off. the latest 3 limes average value will be shown, press the button MEM again. the last measurement value will be shown set  as wall as subsequent measurements can be display 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,  M and “no” will be shown on the display which mean that no memory in store.

About blood pressure

Blood pressure is 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.

• According to the blood pressure classification by the WHO/ISH.

• SYS lower than 100mmHg is considered as hypotension.

• B lood pressure type

Exceptional Situation

Error indicators

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

E- I

| Weak signal or pressure change Suddenly| Wrap the cuff properly
Remeasure with correct way

E-2

| External strong disturbance| When near cell phone or other high radiant device . the measurement will be failed.
Keep quite and no chatting when measure.

E-3

| 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.

E-5

| Abnormal blood pressure| Repeat the measurement after relax for 30 mins . if get unusual readings for 3 times. please contact your doctor

| Low battery| Replace all the worn batteries with new ones.

Trouble removal

batteries 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 working| 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

• Keep the unit In the storage case when no use.
• Clean the unit with soft dry cloth. Do not use any abrasive or volatile cleaners.
• Never immerse the unit or any component in water.

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• Make sure the monitor is off prior to clean ng, a mixture of distilled water and 10 percent bleach could be used.
• Using a spray bottle, moisten a soft cloth towel with the bleach or detergent mix until it is fully saturated. Squeeze any excess moisture from the cloth to avoid any dripping or potential oversaturation of the cuff.
• Wipe all surfaces of the blood pressure monitor cuff thoroughly, making sure to clean the inside and outside of the cuff. Be cautious not to get any moisture In the main unit.
• Using a dry cloth, gently wipe away any excess moisture that may remain on the blood pressure cuff. Lay the cuff flat in an unrolled position and allow the cuff to air dry.

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Maintenance

• Do not clean the body and cuff with naphtha, thinner or gasoline etc.

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• Store the unit in a clean and dry location .

Do not subject the unit to extreme hot or cold temperature. humidity and direct sunlight

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

Specification

Temperature -20C – 55C , Humidity : 10% – 93%

Avoid crash  sun burn or rain during transportation

Expected service life| 5 year
Software| UA1.0
Note : the product cannot be operated at an attitude of 2000m

Warranty information

Statement

• The intended use: the unit is intended to be used by adult at home or medical  center to measure blood pressure pulse rate from the upper arm.
• The unit satisfies the requirements at EN ISO 81060-1 part 1 noninvasive sphygmomanometers.. EN 1060-3-1997+ A22009 Non-invasive sphygmomanometers IEC80601-2-30 Part 2  Non-invasive sphygmomanometers.
• Blood pressure, measurements determined with the device, or equivalent to those  Obtained by a trained observer using
• the cuff/stethoscope auscultatory method. within the limits prescribed by the American national standard manual. electric. or automated sphygmomanometers
• The risk of patient and user can be lowered  acceptable level

Warranty Information

• The unit is guaranteed to be free of defect of workmanship  and materials under normal use for a period of Two Yeas from the date list on the purchase record.
• For repair under this warranty”’. our authorized service agent must be advise of the fault with of the period warranty. This warranty cover part and labour only under normal operation. Any defect resulting form natural causes. eg  blood. hurricane e.t.c is not within  guarantee the guaranty dose not  cover damage incurred By use of the unit not  accordance with the instruction accidental damages or being tampered with or service by unauthorized service agent.
• 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 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 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 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. AII 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 IEC 61000-3-2|

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3|

Compliance

Table 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| ±8 kV contact ±2 kV, t4 kV, a kV, ±15 kV air| ±8 kV contact ±2 kV, t4 kV, t8 kV, -15 kV air
Electrical fast transient/burst IEC 61000-4-4| Power supply lines: ±2 kV 100 kHz repetition frequency| Power supply Ines: ±2 kV 100 kHz repetition frequency
Surge IEC 61000-4-5| line(s) to line(s): ±0.5kV ±1 kV.| Iine (s) to line(s): ±0.5kV ±1 kV.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| 0% 0.5 cycle At 0°, 45 0, 90 °, 135 °. 180 °. 225 0. 270 ° and 315 00% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 250 cycle (50Hz)| 0% 0.5 cycle At 0°. 45 °. 90 °. 135 °, 180 0, 225 °, 270 ° and 315 ° 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 250 cycle ( 50Hz)

Power frequency magnetic field IEC 61000-4-8| 30 Alm 50Hz/60Hz| 30 Alm 501-Iz/60Hz
Conduced RF IEC61000-4-6

| 150KHz to 80MHz: 3Vrms6Vrms (in ISM and amateur radio bands) 80%Am at 1kHz| 150KHz to 80MHz: 3Vrms6Vrms (in ISM and amateur radio bands) 80%Am at 1kHz
Radiated RF IEC61000-4-3

| 10 Vim 80 MHz — 2,7 GHz 80 % AM at 1 kHz| 10 Vim 80 MHz — 2.7 GHz 80 % AM at 1 kHz
NOTE Ur is the a.c. mians voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration -electromagnetic Immunity

Radiated RF IEC61000- 4-3 (Test specifications for ENCLOSU RE PORT IMMUNITY to RF wireless communications equipment| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Distante (m)| IMMUNI TY TEST LEVEL (V/m)
385| 380 —390| TETRA 400| Pulse modulation 18 Hz| 1,8| 0.3| 27
450| 430 —470| GMRS 460. FRS 460| FM ± 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, iDEN 820, CDMA 850, 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. WLN, 802.11 b/g/n. RFID 2450, LTE Band 7| Pulse modulation 217 Hz| 2| 0.3| 28
5240| 5100-5800| WLN, 802.11  a/n| Pulse modulation 217 Hz| 0,2| 0.3| 9
5500
5785

FCC Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user & aposes authority to operate the equipment.

Note: 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 protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off 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.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

FCC RF Exposure Information and Statement

When carrying the product or using it while worn on your body, either use an approved accessory such as a holster or otherwise maintain a distance of 5 mm from the body to ensure compliance with RF exposure requirements. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.

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 , Chuang Wei Road ,Heshuikou Community, Ma Tian

Street, Guang Ming New District, 518106 Shenzhen,

PEOPLE’S REPUBUC 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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