BPM ARM 6331 - Uncategorized TOPCOM - Free user manual and instructions

USER MANUAL BPM ARM 6331 TOPCOM

REP This Blood Pressure Monitor complies with the EC Directives and bears the CE Mark "CE 0197". This blood pressure monitor als complies with mainly the following standards, (including but not limited) Safety standards EN 60601-1 - Medical electrical equipment part 1:General requirements for safety EN 60601-1-2 - Medical electrical equipment part 1-2: 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: http://www.topcom.net/support/cedeclarations.php HL_BPMArm6331.book Page 2 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 3

ENGLISH TOPCOM BPM Arm 6331 1 Introduction Congratulations with your purchase of the Topcom BPM Arm 6331. This fully automatic, arm mounted blood pressure monitor is both easy to use and ideally suited for daily measurements. The large display includes systolic, diastolic and pulse, all clearly shown at the completion of each reading. In addition, you can store up to 30 measurements per Memory Zone, ideal for users who want to monitor and track their blood pressure on a regular basis. The BPM Arm 6331 is compact and portable, making it ideal for home use and travel. 2 Safety instructions

1. This product is for household use only. It is not intended as a substitute for

consultation with your doctor.

2. 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.

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

4. 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.

5. Leaky batteries can damage the unit. Remove the batteries when the unit is not

used for a long time.

6. Do not press the START key when the cuff is not placed around the arm.

7. Do not disassemble the main unit or cuff.

8. If the unit is stored in a cold place, allow it to acclimate at room temperature before

9. Clean the blood pressure monitor body and the cuff carefully with a slightly damp,

soft cloth. Do not press. Do not bend the pre-formed cuff inside out. Do not wash the cuff or use chemical cleaner on it. Never use thinner, alcohol or petrol (gasoline) as cleaner. Please read this manual carefully before use. For specific information on your own blood pressure, contact your physician. Put the user guide away in a safe place for future reference. To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipments, do not use the device near a cell phone or microwave oven. HL_BPMArm6331.book Page 3 Thursday, December 17, 2009 10:39 AM4 REV 1.1 - U8006182

TOPCOM BPM Arm 6331 3Helpful tips Here are a few helpful tips to help you obtain more accurate readings:

• Do not measure your blood pressure immediately after consuming a large meal. To obtain more accurate readings, please wait one hour before measuring.

• Do not smoke or drink alcohol before measuring your blood pressure.

• You should not be physically tired or exhausted while taking a measurement.

• It is important that you relax during measurement. Try to take 15-minutes rest before a reading.

• Do not take measurements if you are under stress or under tension.

• Take your blood pressure at normal body temperature. If you are feeling cold or hot, wait a while before taking a measurement.

• If the monitor is stored at very low temperature (near freezing), have it placed at a warm location for at least one hour before using it.

• Wait about 5 minutes before taking the next pressure measurement. 4 Disposal of the device At the end of the product lifecycle, you should not throw this product into the normal household garbage but bring the product to a collection point for the recycling of electrical and electronic equipments. The symbol on the product, user guide and/or box indicate this. Some of the product materials can be re-used if you bring them to a recycling point. By re-using some parts or raw materials from used products you make an important contribution to the protection of the environment. Please contact your local authorities in case you need more information on the collection points in your area. 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. HL_BPMArm6331.book Page 4 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 5

The World Health Organization (WHO) and National High Blood Pressure Education Program has developed a Blood pressure standard, according to which areas of low and high-risk blood pressure are identified. This standard however, is a general guideline as individual's blood pressure varies among different people and different groups, etc. It is important that you consult with your physician regularly. Your physician will tell you your normal blood pressure range as well as the point at which you will be considered at risk.

5.4 Blood Pressure Fluctuation

Blood pressure fluctuates all the time! You should not be worried if you encountered two or three measurements at high levels. Blood pressure changes over the month and even throughout the day depending on circumstances (state of mind, temperature, ...) Ex. Fluctuation within the day for a Male, 35 years old. Systolic >= 160 Diastolic >= 100 Stage 2 Hypertension Systolic 140 - 159 Diastolic

Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 5 Thursday, December 17, 2009 10:39 AM6 REV 1.1 - U8006182

TOPCOM BPM Arm 6331 6 Battery installation

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

• Insert 4 AA non - rechargeable batteries. Follow the polarity as indicated in the battery compartment. 7 Buttons

When the Battery Low Indicator is displayed, the batteries needs to be replaced. Do not shortcircuit & dispose of in fire. Remove the battery if this device is not going to be used for a long period.

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2. Diastolic pressure

1. Remove all watches, jewelry, etc.

prior to attaching the Arm cuff.

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 brachialartery on the inside of the arm.

5. Pull the cuff so that the top and

bottom edges are tightened around your arm. mmHg

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1. This monitor automatically switches off 1 minute after the last key operation.

2. To interrupt the measurement, simply press any key. The cuff will deflate

immediately after a key is pressed.

3. During the measurement, do not talk or move your arm or hand muscles.

4. After each measurement, the result will be automatically stored. The BPM ARM

6331 has 3 memory zones with each 30 location. Select the desired Memory Zone before measurement (see §11)

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.

1. Press the SET button repeatedly to

select the desired memory zone.

2. Press the START/STOP button to

start measurement. The cuff will inflate to the level that is right for you.

3. When the right level is reached, the

cuff will deflate. mmHg mmHg HL_BPMArm6331.book Page 8 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 9

4. When the measurement is

completed, systolic, diastolic and pulse will be shown simultaneously on the LCD screen. When a mistake was detected dur- ing measurement the Error mark appears on the display The BPM 6331 has 3 Memory zones. Each can store up to 30 measurements including the date and time The result will be stored automatically in the selected Memory Zone after the measurement. Select the desired Memory Zone before measurement, by pressing the SET button repeatedly. To recall measurement results:

• Press the SET button repeatedly to select the desired memory zone.

• Press the MEMORY button to see the average of all measurement results [A].

• Press the MEMORY button again to see the last measurement result.

• Press the MEMORY button repeatedly for prior values stored.

• To stop reading the data, press the START/STOP button to switch back to normal time. To erase all data from one memory zone:

• Press the SET button repeatedly to select the desired memory zone.

• Press the MEMORY button to see the last measurement result.

• Press the MODE and SET button simultaneously to erase all data from the selected memory zone. mmHg ERROR mmHg When the batteries are installed, the data in the memories will not be lost even when the Blood Pressure Monitor is switched off. HL_BPMArm6331.book Page 9 Thursday, December 17, 2009 10:39 AM10 REV 1.1 - U8006182

TOPCOM BPM Arm 6331 12 Time adjustment 13 Technical specifications *Specifications are subject to change without notice. To adjust the date and time:

• Press the SET button to activate the display. The memory zone will be displayed.

• Press the MODE button, the month will blink on the display.

• Press the SET button succesively to change the month.

• Press the MODE button to confirm the month. The day will blink on the display.

• Change the day, hours and minutes as described above, using the SET button to change and the MODE button to confirm every setting.

• After setting the minutes, the device is ready to use. Model Power source Measurement zone Accuracy Pressure sensor Inflation Deflation Memory capacity Auto-shut-off Operation environment Storage environment Weight Cuff Arm circumference Limited patient Classification BPM Arm 6331 6V DC: 4 x AA - 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 30 memories 1 minute after last key operation +10°C~+40°C 85% RH max. -20°C~+70°C 85% RH max. 265g (with batteries) 23~33 cm / 9~13 in Over 18 years old

• Internally powered equipment

• Classification of type BF

• Not suitable for use in presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide

• Continuous operation with short-time loading HL_BPMArm6331.book Page 10 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 11

ENGLISH TOPCOM BPM Arm 6331 The CE symbol indicates that the unit complies with the essential requirements of the directive 93/42/EEC. 14 Topcom Warranty

14.1 Warranty period

The Topcom units have a 24 - month warranty period. The warranty period starts on the day the new unit is purchased. The warranty on batteries is limited to 6 months after purchase. 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 purchase receipt, on which the date of purchase and the unit-model are indicated.

14.2 Warranty handling

A faulty unit needs to be returned to a Topcom service centre including a valid purchase note. If the unit develops a fault during the warranty period, Topcom or its officially appointed service centre will repair any defects caused by material or manufacturing faults free of charge. Topcom will at its discretion fulfill its warranty obligations by either repairing or exchanging the faulty units or parts of the faulty units. In case of replacement, colour and model can be different from the original purchased unit. The initial purchase date shall determine the start of the warranty period. The warranty period is not extended if the unit is exchanged or repaired by Topcom or its appointed service centres.

14.3 Warranty exclusions

Damage or defects caused by incorrect treatment or operation and damage resulting from use of non-original parts or accessories not recommended by Topcom are not covered by the warranty. The warranty does not cover damage caused by outside factors, such as lightning, water and fire, nor any damage caused during transportation. No warranty can be claimed if the serial number on the units has been changed, removed or rendered illegible. Any warranty claims will be invalid if the unit has been repaired, altered or modified by the buyer or by unqualified, non-officially appointed Topcom service centres. To ensure precise measurement reading, recalibration of the device is recommended after 2 years from the date of purchase. Shipping plus handling cost and recalibration service fee shall be charged accordingly. (www.topcom.net) HL_BPMArm6331.book Page 11 Thursday, December 17, 2009 10:39 AM12 REV 1.1 - U8006182

Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 14 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 15

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Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 23 Thursday, December 17, 2009 10:39 AM24 REV 1.1 - U8006182

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mmHg Systolic Diastolic HL_BPMArm6331.book Page 32 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 33

1.5cm HL_BPMArm6331.book Page 34 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 35

Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 41 Thursday, December 17, 2009 10:39 AM42 REV 1.1 - U8006182

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• Kontinuerlig drift tack vare kort starttid. HL_BPMArm6331.book Page 46 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 47

Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 50 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 51

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1.5cm HL_BPMArm6331.book Page 52 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 53

Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 59 Thursday, December 17, 2009 10:39 AM60 REV 1.1 - U8006182

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1.5cm HL_BPMArm6331.book Page 61 Thursday, December 17, 2009 10:39 AM62 REV 1.1 - U8006182

mansjetten tømmes for luft. mmHg mmHg HL_BPMArm6331.book Page 62 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 63

Stage 1 Hypertension

mmHg Systolic Diastolic HL_BPMArm6331.book Page 68 Thursday, December 17, 2009 10:39 AMTOPCOM TWINTALKER 3000 69

3. START / STOP painike

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mansetti tyhjentyy. mmHg mmHg HL_BPMArm6331.book Page 71 Thursday, December 17, 2009 10:39 AM72 REV 1.1 - U8006182

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 outputpower of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz d=1,2 80 MHz to 800 MHz d=1,2 800 MHz to 2,5 GHz d=2,3 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1,2 1,2 2,3 3,8 3,8 7,3

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. HL_BPMArm6331.book Page 75 Thursday, December 17, 2009 10:39 AM76 REV 1.1 - U8006182 NEDERLANDS BPM ARM 6331 visit our website www.topcom.net MD14300048-1 HL_BPMArm6331.book Page 76 Thursday, December 17, 2009 10:39 AM