BD4601 - Blood pressure monitor TOPCOM - Free user manual and instructions

USER MANUAL BD4601 TOPCOM

REP Keep dry.This Blood Pressure Monitor complies with the EC Directives and bears the CE Mark "CE 0197". This blood pressure monitor also complies with mainly following standards, (including but not limited). Safety standards EN 60601-1 - Medical electrical equipment part 1:General requirements for safety EMC Standard EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety- Collateral standard: Electromagnetic compatibility - Requirements and tests Performance standards: EN 1060-1 Non-invasive sphygmomanometers - General requirements EN 1060-3 Non-invasive sphygmomanometers - Supplementary requirements for electromechanical blood pressure measuring systems. EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. The declaration of conformity can be found on: www.tristar.eu Puede encontrarse la Declaración de conformidad en: www.tristar.eu4 BD-4601 (BPM Arm 1500) Dear customer, We request that you read this information in order to quickly become familiar with this equipment and learn how to use its functions. 1 Information Regarding This User Guide This user guide contains information on the BD-4601 (referred to as ‘the equipment’ in the following) and provides important instructions on the initial use, safety, proper use and maintenance of this equipment. Always keep the user guide available near the equipment. Every person responsible for operating, repairing or cleaning the equipment must read and/or consult the user guide. Keep this user guide in a safe place and give it to the next owner of the equipment. 2 Copyright This document is protected by copyright legislation. All rights are reserved, including rights of photo mechanical reproduction, copying or distribution using specific means such as data processing, data storage media or data networks, either in full or in part, as well as technical changes and changes to the contents. 3Warnings CAUTION This warning points out a potentially hazardous situation. Injuries and/or material damage may result if the hazardous situation cannot be avoided. Follow instructions for use. 4 General rules when using the equipment This device uses the oscillometric method to measure systolic and diastolic blood pressure as well as your heart rate. This product is for household use only. This product is recommended for users over the age of 18, and should not be used by children. It is not intended as a substitute for consultation with your doctor. All other forms of use are improper and can lead to hazards. Always follow the instructions provided in this user guide. No liability is accepted for any loss or damage resulting from improper use. The user of the equipment is exclusively responsible for all risks. CAUTION

• The unit should not be operated by children so to avoid hazardous situations.

• For users diagnosed with common arrhythmia (atrial or ventricular premature beats or atrial fibrillation), diabetes, poor circulation of blood, kidney problems, or for users suffered from stroke, or for unconscious users, the device might not be suitable for use. Consult your doctor in case of any doubt.

• The unit contains high-precision assemblies. Therefore, avoid extreme temperatures, humidity, and direct sunlight. Avoid dropping or strongly shocking the main unit, and protect it from dust.

• Do not press the start key when the cuff is not placed around the arm.

• Do not disassemble the main unit or cuff To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipment, do not use the device near a cell phone or microwave oven.At least keep a maximum output power of 2 W yields and a distance 3.3m away from this equipment.5 ENGLISH BD-4601 (BPM Arm 1500) 5 Blood pressure

5.1 What is Blood Pressure?

Blood pressure is the pressure exerted on the artery tube while blood flows through the arteries. The pressure measured when the heart contracts and sends blood out of the heart is systolic (highest). The pressure measured when the heart dilates with blood flowing back into the heart is called diastolic (lowest) blood pressure.

5.2 Why Measure Your Blood Pressure?

Among the various health problems afflicting modern people, problems associated with high blood pressure are by far the most common. High blood pressure's dangerously strong correlation with cardiovascular diseases and high morbidity has made measuring blood pressures a necessity of identifying those at risk.

• If the unit is stored in a cold place, allow it to acclimatize at room temperature before use.

• Do not take a measurement in a low (less than 41 °F/5 °C) or high (more than 104 °F/40 °C) temperature or you may get the inaccurate readings.

• Wait 30 ~ 45 minutes before measurement if you’ve just consumed beverages containing caffeine or smoked cigarettes.

• Rest at least 5 ~ 10 minutes before taking a measurement.

• Relax at least 3 ~ 5 minutes in between measurements.

• Make sure the cuff plug is attached to the monitor.

• We recommend you using the same arm (preferably the left arm) and measuring around the same time each day.

• Perform measurements in a quiet and relaxed environment at room temperature.

• Sit down comfortably and place your arm on the table with your feet flat on the floor.

• Wrap the cuff snugly around your exposed upper arm and lay your arm on a table or a flat surface at the same level as your heart. Your feet should be flat on the floor.

• Do not move or shake the device during a measurement.

• Blood pressure measurements should be interpreted by a physician or a trained health professional who is familiar with your medical history.

• Using the unit and recording the results regularly for your physician to interpret, you will keep your physician informed of the continuing changes in your blood pressure.

• If you have one of the circulatory problems as arteriosclerosis, diabetes, liver disease, kidney disease, severe hypertension, peripheral circulation......, please consult your healthcare professional before using the device.

• This product is not suitable for people with arrhythmia and pregnant women..

• Blood pressure measurements taken with this device are equivalent to those obtained by a trained observer using the cuff / stethoscope auscultation method and are within the accuracy limits prescribed by the Standard of EN 1060-4..

• This product is not a toy. Don’t let children play with it.

• To avoid accidental strangulation, keep this product away from children. Don’t let them wrap the tube around their neck.6 BD-4601 (BPM Arm 1500)

5.3 Blood Pressure Standard

This device is equipped with a WHO Blood Pressure Indicator which classifies your blood pressure measurements into six stages (Optimal to Severe hypertension) based on WHO classification on blood pressure levels as shown in below chart. After each measurement is completed, the LCD display will show your position automatically on the six segments of the bar indicator which corresponds to WHO Blood Pressure Indicator

The symbol will appear on the display, indicating a certain heartbeat irregularity was detected during measurement. The heartbeat rhythm that is more than or less than 25% from the average rhythm is usually defined as an irregular heartbeat rhythm. Talking, moving, shaking or an irregular pulse during the measurement can result in the appearance of this symbol. Usually this is not a cause for concern, however if the symbol appears often, we recommend you seek medical advice.And please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. Stages of blood pressure levels Indicator Systolic in mmHg Diastolic in mmHg Our recommendation Grade 3- Severe hypertension Red

Take medical treatment at once Grade 2 - Moderate hypertension Orange 160 ~ 179 100 ~109 Seek medical advice Grade 1 - Mild hypertension Yellow 140 ~ 159 90 ~ 99 Check it regularly by doctor High - normal Green 3 130 ~ 139 85 ~ 89 Check it regularly by doctor Normal Green 2 120 ~ 129 80 ~ 84 Check it yourself Optimal Green 1 < 120 < 80 Check it yourself

• No Irregular Heartbeat Detector measurement will be stored in memory.

• The pulse display is not suitable for checking the frequency of heart pacemarkes. If a certain pulse irregularity is detected during measurement often, we recommend you seek medical advice.

• However, as a safeguard, we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial fibrillation or any other special conditions you should check with your physician before using your device.

• The IHB function is not designed for use by people with arrhythmias nor for diagnosing or treating an arrhythmic problem. In order to filter the unstable status of user and avoid affecting the detection of heart rate from any movement, shaking or talking in the beginning of measurement, the method of averaging heart beat intervals for subject device is calculated with the three proper heart beat pulses detected in the beginning of measurement and that is different from a strict mathematical averaging of all recorded intervals.

• At least 3 beats with at least 25% difference from the average heart beat interval will generate the IHB icon on the screen.7 ENGLISH BD-4601 (BPM Arm 1500) 6 Product description

BD-4601 (BPM Arm 1500) 8 Installing batteries CAUTION Failure to use batteries according to instructions can be hazardous.

• Always use Alkaline batteries of the same type.

• Ensure that batteries are installed with correct polarity. Damage to the batteries and the equipment can result from installation with incorrect polarity.

• Never toss batteries into a fire, due to the risk of explosion.

• Never allow battery terminals to come into contact with each other or with metal objects, either intentionally or accidentally. This can cause overheating, fire or explosion.

• Keep batteries out of the reach of children. Consult a doctor immediately in case of swallowing.

• Fluid from leaking batteries can cause permanent damage to the equipment. Take particular care when handling damaged or leaking batteries, due to the risk of corrosion. Wear safety gloves.

• Remove the batteries if the equipment will not be used for an extended period.

• Open the battery compartment by pulling the cover away on the bottom of the unit.

• Insert 4 AAA Alkaline batteries. Follow the polarity as indicated in the battery compartment. When the batteries are low, is displayed. Low batteries must be replaced. 9 Setting date and time To adjust the date and time:

to activate the display. The memory zone will be displayed.

, the year will blink on the display.

successively to change the year.

to confirm the year. The month will blink on the display.

• Change the month, day, hours and minutes as described above, using the mode button

to change and the set button

to confirm every setting.

• After setting the minutes, the device is ready to use.9 ENGLISH BD-4601 (BPM Arm 1500)

1. Remove all watches, jewellery, etc. prior to attaching

2. Press your brachial artery by two fingers

approximately 2,5 cm above the elbow on the inside of your left arm to determine where your strongest pulse is.

3. Slide the end of arm cuff furthest from the tube through

the metal ring to a loop. The smooth cloth should be on the inside of the cuff. The Velcro will be on the outside of the cuff.

4. Put the left arm through the cuff loop. The bottom of

the cuff should be approx. 1,5 cm above the elbow. The cuff should lie over the brachial artery on the inside of the arm.

5. Pull the cuff so that the top and bottom edges are

tightened around your arm.

6. When the cuff is positioned properly, press the Velcro

firmly against the pile side of the cuff. The metal ring will not touch your skin.

7. Relax your entire body, especially the area between

your elbow and fingers. Place your elbow on a table so that the cuff is at the same level as your heart. Avoid leaning back while the measurement is being taken. Applying the cuff 11 Taking measurement When the batteries are installed.

to activate the display. The memory zone is displayed.

repeatedly to select the desired memory zone.

to start measurement. After all segments are displayed, the cuff will inflate to a level that is right for you. To interrupt the measurement, you may press the START/ STOP button. The cuff will deflate immediately after a button is pressed.10 BD-4601 (BPM Arm 1500) 12 Memory function

After each measurement, the systolic and diastolic pressure, heart rate with the time and date will be automatically stored. The monitor features a 3 zone memory capability. Each memory zone holds the last 40 measurements, replacing the oldest data with new one.

repeatedly to select the desired memory zone.

to enter memory mode.

again to see the last measurement result.

repeatedly for prior records stored.

switch back to stand-by. To erase all data from one memory zone:

repeatedly to select the desired memory zone.

to see the last measurement result.

simultaneously to erase all data from the selected memory zone.

• After the initial inflation of the cuff, the pressure will slowly decrease and when a pulse is detected, the heart rate symbol will start flashing.

• When the measurement is finished, the systolic pressure , diastolic pressure , heart rate and WHO indicator will be displayed for 1 minute.

• The monitor will automatically shut off after 1 minute if no button is pressed. – If there is no data in the selected memory zone, nothing (except month, date, time and memory zone number) will appear on the display. – If there’s 1 record, the first reading will be the only measurement records, indicates with the average symbol

– If there are multiple records, the first reading will be the average of the last 3 records, indicated with the average symbol .

ENGLISH BD-4601 (BPM Arm 1500) 13 Symbol indication / Troubleshooting Display symbol Condition/Cause Corrective action The flashing heart will appear when the pulse is detected during a measurement. Measurements in process. Do not talk or move. Appears when the battery voltage is excessively low or the position of batteries is incorrect. Replace all batteries with new ones. Make sure the +/- polarity is correct. Appears for 1 minute when the user was talking, moving or shaking or an irregular heart beat was detected during measurement. Repeat the measurement. Note that you be relaxed for at least 5 minutes and sit comfortably and quietly before you restart a measurement. Indicates the average of last 3 measurements. Indicates the number of measurements stored in the memory. Appears when measurement error occurs or the blood pressure value is displayed excessively low or high. Replace all batteries with new ones. Make sure the +/- polarity is correct. Air circuit abnormality. Cuff tube may not be plugged into monitor correctly. Check the cuff connection. Measure again. Inflation pressure exceeding 300 mmHg. Turn the device off, then measure again. Error determining measurement data. Measure again. Note: If “EP” appears on the display, just return the devise to your local distributor or importer.12 BD-4601 (BPM Arm 1500) 14 Technical specifications Model Power source Measurement zone Accuracy Pressure sensor Inflation Deflation Memory capacity Auto-shut-off Operation environment Storage/transportation environment Weight Cuff Arm circumference Limited patient Classification BD-4601 (BPM Arm 1500) 4 x AAA (1,5V) - Alkaline batteries Pressure: 0~300 mmHg Pulse: 40~199 beats/minute Pressure: ±3 mmHg Pulse: within ±5% of reading Semi-conductor Automatic - Pump driven Automatic Pressure release valve 3 Memory zones for each 40 memories 1 minute after last key operation +5°C~+40°C (41°F ~ 104°F)- Humidity 15% ~ 93% R.H. -25°C ~ 70°C (-13°F ~ 158°F) Humidity ≤ 93% R.H. 212g (with batteries) 23~33 cm (9~13 inch) Over 18 years old Internally powered equipment Classification of type BF(applied part) IPX0 Not suitable for use in presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide Continuous operation with short-time loading 15 Maintenance

• Use a piece of cloth with water or mild cleansing agent to wipe the device and dry it immediately with a dry cloth.

• Do not use detergent or any strong chemicals to clean the device.

• Use only a dry cloth to wipe the cuff.

• If the device is not to be used for a long time, please remove the batteries from the device (leaking of battery acid can cause the device to malfunction).

• Do not twist the cuff.

• Do not drop the product and avoid any strong impacts.

• Do not attempt to disassemble or change any parts of the monitor, including arm cuff, due to substitution of a component different from that supplied might result in measurement error.

• Always store the unit in the pouch after use.

• Do not place the device directly under sunlight, in high temperature, or in humid or dusty places.

• Do not store the device in extremely low (less than -25°C/-13°F) or high (more than 70°C/158°F) temperature. 16 Disposal (environmental protection) Dispose of the device in accordance with EC Directive 2002/96/EC-WEEE (Waste Electrical and Electronic Equipment). If you have any queries, please contact your local body responsible for waste disposal. Batteries should be disposed of in an environmentally friendly manner in accordance with local regulations.13 ENGLISH BD-4601 (BPM Arm 1500) 17 Tristar Warranty

17.1 Warranty period

The Topcom units have a 24-month warranty period. The warranty period starts on the day the new unit is purchased. There is no warranty on Alkaline batteries (AA/AAA type). Consumables or defects causing a negligible effect on operation or value of the equipment are not covered. The warranty has to be proven by presentation of the original or copy of the purchase receipt, on which the date of purchase and the unit-model are indicated.

5. Start/stopp-knapp

The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

Voltage fluctuations/ flicker emissions

Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment

r8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Power frequency (50/60 Hz) magnetic field

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Compliance level Electromagnetic environment

3 Vrms 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the deivce should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the deivce as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.® BD-4601 visit our website www.tristar.eu MD14300343-1