HOLOGY HBP10 Upper Arm Electronic Blood Pressure Monitor User Manual

HOLOGY HBP10 Upper Arm Electronic Blood Pressure Monitor User Manual

Please kindiy comply with English manual and other language manuals are only for reference

Introduction

• This new digital blood pressure monitor uses the oscillometric method of blood pressure measurement. Which means that 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.
• This automatic blood pressure monitor could measure the systolic pressure, diastolic pressure and pulse, the components are included the body, cuff and printed instruction manual. Batteries and adapter are optional. This unit is intended for adult 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 classification index.
• 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.

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.

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. Please follow the instructions of your physician.
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 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 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 equipment.
Use the right cuff, otherwise it can not measurement correctly.
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 in operational failure.
Please avoid using in high radiation 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 facillities.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

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 AA 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 AA 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 longtime.

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

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 -I-I or claus 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 over the above mentioned requirements.
   If in doubt, consult your local representative or the technical service department.

2. 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.

3. Insert the adapter plug into the hole on the backside of the unit as picture.

4. Insert the other side of the adapter into the outlet with 100-240V.

5. To remove the AC adapter, disconnect the adapter plug from the outlet first and then disconnect the cord from the unit’s socket.

Note:
When use AC adapter, please remove the battery.
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.

Adapter technical features:
Output voltage: Micro USB 5Vt5%
Output current: At least 600 mA

Setting mode

Proper use of the unit

Measurement
Preparation before 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 error factors
All efforts by the patient to support their arm will affect measurement reading. Please make sure you are in a comfortable, relax position and do not strain your the muscles in the measu-rement arm during measurement. Use a cushion for support if necessary. If the arm artery lies lower or higher than the height of the heart will affect measurement reading.

Note:
Please use clinically approved cuffs only.
A loose cuff or a exposed bladder will causes false reading.
With repeated measurements , blood accumulates in the arm which will lead to false reading.
Please do not repeat the measurement for a short time, blood will accumulate in the arm,
which will cause false readings. The measurement should be made after a 3 minute pause or raising your arm to allow the accumulated blood to drain.

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 ilustrated. 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 end of the cuff and close the cuff by affixing the velcro.
5. The cuff should be snug on your upper arm and also can fit 2 fingers between the cuff and your upper arm. Any piece of clothing will affect measurement results so need to be removed.
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) and make 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. Please make sure use the same arm for every measurement

About blood pressure

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.

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 I 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 like 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 no calibration required.
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 equipment(detail model name), 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. 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

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