Rossmax AV151 User Manual

Model: AV151 f
EN
Instruction Manual
www.rossmaxhealth.com
1. Introduction
Blood pressure measurements determined with AV151f are equiva­lent to those obtained by a trained observer using cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers. This unit is to be used by adult consumers in a home environment. Do not use this device on infants or neonates. AV151f is protected against manufacturing defects by an established International War­ranty Program. For warranty information, you can contact the manu­facturer, Rossmax International Ltd.
Attention: Consult the accompanying documents. Please read this
manual carefully before use. For specic information on
your own blood pressure, contact your physician. Please be sure to keep this manual.
2. Name/Function of Each Part
Arm Cuff
Air Tube and Connector
4“AA”(R06) size,
1.5V batteries.
LCD Display
ON/OFF/START key
Memory Key
Battery Cover (Located on back of unit)
3. Real Fuzzy Measuring Technology
This unit uses the oscillometric method to detect your blood pressure.
Before the cuff starts inating, the device will establish a baseline cuff
pressure equivalent to the air pressure. This unit will determine the
appropriate ination level based on pressure oscillations, followed by cuff deation. During the deation, the device will detect the amplitude and slope
of the pressure oscillations and thereby determine for you the systolic blood pressure, diastolic blood pressure, and pulse.
4. Preliminary Remarks
This Blood Pressure Monitor complies with the European regulations and bears the CE mark “CE 0366”. The quality of the device has been
veried and conforms to the provisions of the EC council directive
93/42/EEC (Medical Device Directive), Annex I essential requirements and applied harmonized standards. EN 1060-1: 1995/A1: 2002 Non-invasive sphygmomanometers - Part 1 - General requirements EN 1060-3: 1997/A2: 2009 Non-invasive sphygmomanometers - Part 3 - Supplementary requirements for electro-mechanical blood pres­sure measuring systems EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test Procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. This blood pressure monitor was designed for long service time. To ensure accurate measurements, this monitor is recommended to be re-calibrated every two years.
5. Blood Pressure Standard
The National High Blood Pressure Education Program Coor­dinating Committee has developed a blood pressure standard,
classifying blood pressure ranges into 4 stages. (Ref. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure-Complete Report JNC-7, 2004).
This blood pressure classification are based on historical data, and may not be directly applicable to any particular patient. 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. For reliable monitoring and reference of blood pressure, keeping long- term re­cords is recommended. Please download the blood pressure log at www.rossmaxhealth.com.
6. Blood Pressure Fluctuation
Blood pressure uctu­ates all the time!
You should not be overly worried if you encoun­tered two or three meas­urements at high levels. Blood pressure changes over the month and even throughout the day. It is
also inuenced by season
and temperature.
7. Display Explanations
1. Memory Mark
2. Weak Battery Mark
3. Pulse Mark
4. Pulse Rate
5. Systolic Pressure
6. Diastolic Pressure
7. Irregular Heartbeat Detector (IHB)
1
2 3
4
5
6
7
8. Irregular Heartbeat Detector (IHB)
This unit is equipped with an Irregular Heartbeat Detector (IHB) which allows those who have an ir­regular heartbeat to obtain accurate measurements alerting the user of the presence of an irregular heart beat during the measurement.
Note: It is strongly recommended that you consult
your physician if the IHB icon ( ) appears often.
9. Installing Batteries
1. Press down and lift the battery cover in the direction of the arrow to open the battery compartment.
2. Install or replace 4 “AA” sized batteries in the battery compartment according to the indications inside the compartment.
3. Replace the battery cover by clicking in the bottom hooks rst, then
push in the top end of the battery cover.
4. Replace the batteries in pairs. Remove batteries when unit is not in use for extended periods of time.
You need to replace the batteries when
1. low battery icon appears on display.
2. the ON/OFF/START key is pressed and nothing appears on
display.
Caution
1. Batteries are hazardous waste. Do not dispose them together with the household garbage.
2. There are no user serviceable parts inside. Batteries or damage from old batteries are not covered by warranty.
3. Use exclusively brand batteries. Always replace with new batteries to­gether. Use batteries of the same brand and same type.
10. Applying the Cuff
1. Unwrap the arm cuff, leaving the end of the cuff through the
D-ring of the cuff.
2. Put your left arm through the cuff loop. The color strip indication
should be positioned closer to you with the tube pointing in the direction of your arm (Fig. 1). Turn your left palm upward and place the edge of the arm cuff at approximately 1.5 to 2.5 cm above the inner side of the elbow joint (Fig. 2). Tighten the cuff by pulling the end of the cuff.
3. Center the tube over the middle of the arm. Press the hook
and loop material together securely. Allow room for 2 fingers to fit between the cuff and your arm. Position the artery mark (Ø) over the main artery (on the inside of your arm) (Fig. 3,4).
Note: Locate the main artery by pressing with 2 fingers approxi­mately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.
4. Plug in the cuff connecting tube into the unit (Fig. 5).
5. Lay your arm on a table (palm upward) so the cuff is at the same height as your heart. Make sure the tube is not kinked (Fig. 6).
6. This cuff is suitable for your use if the arrow falls within the solid color line as shown on the right (Fig. 7). If the arrow falls outside the solid color line, you will need a cuff with other circumferences. Contact your local dealer for additional size cuffs.
Fig.1
Fig.5
Fig.2
Fig.4
Fig.6
Fig.3
Fig.7
11. Measurement Procedures
Here are a few helpful tips to help you obtain more accurate readings:
• Blood pressure changes with every heartbeat and is in constant
fluctuation throughout the day.
• Blood pressure recording can be affected by the position of the user,
his or her physiological condition and other factors. For greatest accuracy, wait one hour after exercising, bathing, eating, drinking beverages with alcohol or caffeine, or smoking to measure blood pressure.
• Before measurement, it’s suggested that you sit quietly for at least
5 minutes as measurement taken during a relaxed state will have greater accuracy. You should not be physically tired or exhausted while taking a measurement.
• Do not take measurements if you are under stress or tension.
• During measurement, do not talk or move your arm or hand
muscles.
• 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 5 minutes before taking the next measurement.
1. Press the ON/OFF/START key. All displays will appear for approxi­mately one second before returning to “0”.
2. The unit will automatically inflate to the appropriate inflation level based on the user’s pulse oscillations. Measurement will then be­gin. It is important to remain still and quiet during measurement. Any significant movement may affect measurment results.
3. When the measurement is completed, systolic, diastolic and pulse will be shown simultaneously and be saved automatically in memory system. Up to 90 memories can be saved.
4. Measurement is now completed. Press the ON/OFF/START key to turn off the power. If no key is pressed, the unit will shut off automatically in 1 minute.
This monitor will re-inflate automatically to approximately 220 mmHg if the system detects that your body needs more pressure to measure your blood pressure. Note: 1. This monitor automatically switches off approximately 1
minute after last key operation.
2. To interrupt the measurement, simply press the Memory or
ON/OFF/START key; the cuff will deflate immediately.
3. During the measurement, do not talk or move your arm or
hand muscles.
12. Recalling Values from Memory
1. To recall stored blood pressure readings from memory, simply press the Memory key. The last set of memorized readings will be displayed.
2. Another press of the Memory key will recall the previous set of readings.
3. All readings stored in memory will be displayed with its sequence number.
13. Clearing Values from Memory
Press and hold the Memory key for approximately 5 seconds, then the data in the memory zone can be erased automatically.
14. Troubleshooting
If any abnormality should arise during use, please check the following points.
EE / Measurement Error:
Make sure the L-plug is securely connected to the air socket and measure again. Wrap the cuff correctly and keep arm steady during measurement. If the error keeps occurring, return the device to your local distributor or service center.
E1 / Air Circuit Abnormality:
Make sure the L-Plug is securely connected to the air socket on the side of the unit and measure again. Another possible cause can be due to the short circuit of the microphone embedded in the cuff. If the errors still occur, return the device to your local distributor or service center for help.
E2 / Pressure Exceeding 300 mmHg:
Switch the unit off and measure again. If the error keeps occurring, return the device to your local distributor or service center.
E3 / Data Error:
Remove the batteries, wait for 60 seconds, and reload. If the error keeps occurring, return the device to your local distributor or service center.
Er / Exceeding Measurement Range:
Measure again. If the error keeps occurring, return the device to your local distributor or service center.
No display when the ON/OFF key is pressed:
Re-insert the
batteries in the correct positions.
Note:
If the unit still does not work, return it to your dealer. Under no circumstance should you disassemble and repair the unit by your­self.
15. Cautionary Notes
1. 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.
2. Clean the blood pressure monitor body and the cuff carefully with a slightly
damp, soft cloth. Do not press. Do not wash the cuff or use chemical cleaner on it. Never use thinner, alcohol or petrol (gasoline) as cleaner.
3. Leaky batteries can damage the unit. Remove the batteries when the unit is
not used for a long time.
4. The unit should not be operated by children so to avoid hazardous situations.
5. If the unit is stored near freezing, allow it to acclimate at room temperature
before use.
6. This unit is not field serviceable. You should not use any tool to open the
device nor should you attempt to adjust anything inside the device. If you have any problems, please contact the store or the doctor from whom you purchased this unit or please contact Rossmax International Ltd.
7. As a common issue for all blood pressure monitors using the oscillometric
measurement function, the device may have difficulty in determining the proper blood pressure 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.
8. To stop operation at any time, press the ON/OFF/START key, and the air in the
cuff will be rapidly exhausted.
9. Once the inflation reaches 300 mmHg, the unit will start deflating rapidly for safety reasons.
10. Please note that this is a home healthcare product only and it is not intended
to serve as a substitute for the advice of a physician or medical professional.
11. Do not use this device for diagnosis or treatment of any health problem or
disease. Measurement results are for reference only. Consult a healthcare professional for interpretation of pressure measurements. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or healthcare professional.
12. Electromagnetic interference: The device contains sensitive electronic
components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens). These may lead to temporary impairment of measurement accuracy.
13. Dispose of device, batteries, components and accessories according to local
regulations.
14. This monitor may not meet its performance specification if stored or used
outside temperature and humidity ranges specified in Specifications.
16. Specications
Measurement Method Oscillometric Measurement Range Pressure: 40~250 mmHg; Pulse: 40~199 beats/ minute Pressure Sensor Semi conductor Accuracy Pressure: ± 3mmHg; Pulse: ± 5% of reading Inflation Pump Driven Deflation Automatic Air Release Valve Memory capacity 90 memories Auto-shut-off 1 minute after last key operation Operation Environment 10°C~40°C (50°F~104°F); 40%~85% RH Storage Environment -10°C~60°C (14°F~140°F); 10%~90% RH DC Power Source DC 6V four R06 (AA) Batteries Dimensions 145 (L) X 105 (W) X 75 (H) mm Weight 384.5g (G.W.) (w/o Batteries) Arm circumference Adult: 24~36 cm (9.4”~14.2”) Limited Users Adult users
: Type BF :Device and cuff are designed to provide special
*Specifications are subject to change without notice.
protection against electrical shocks.
17. EMC guidance and manufacturer’s declaration
The AV151f is intended for use in the electromagnetic environment specied below. The customer or the user of the AV151f should assure that it is used in such an environment.
RF emissions CISPR 11 Group 1 The AV151f uses RF energy only for its internal function. Therefore, its
RF emissions CISPR 11 Class B The AV151f is suitable for use in all establishments, including domestic Harmonic emissions IEC 61000-3-2
Voltage uctuations/icker
emissions IEC 61000-3-3
Guidance and manufacturer’s declaration-electromagnetic emissions
Emission test Compliance Electromagnetic environment-guidance
RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
establishments and those directly connected to the public low-voltage
Not applicable
power supply network that supplies buildings used for domestic purposes.
Not applicable
Guidance and manufacturer’s declaration-electromagnetic immunity
The AV151f is intended for use in the electromagnetic environment specied below.
The customer or the user of the AV151f should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast
transient/burst
IEC 61000-4-4 Surge IEC 61000­4-5
Voltage Dips,
short interruptions and voltage vari-
ations on power
supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) mag­netic eld IEC
61000-4-8
The AV151f is intended for use in the electromagnetic environment specied below. The customer or the user of the AV151f should assure that is used in such and environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from
a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be les than 3 V/m.
± 6 kV contact ± 8 kV air
± 2kV for power supply lines ± 1kV for input/output lines
± 1kV line(s) to line(s) ± 2kV line(s) to earth
<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s
3 A/m 3 A/m Power frequency maganetic elds should be at
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration-electromagnetic immunity
3 Vrms
150 KHz to 80 MHz
3 V/m 80MHz to 2,5 GHz
structures, objects and people.
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the AV151f is u sed exceeds the applicable RF compliance level above, the AV151f should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AV151f.
Not applicable
3 V/m
± 6 kV contact ± 8 kV air
Not applicable Not applicable
Not applicable Not applicable Not applicable
Not applicable
Not applicable
Not applicable
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the rela­tive humidity should be at least 30% Mains power quality should be that of a typical com­mercial or hospital environment.
Mains power quality should be that of a typical com­mercial or hospital environment. Mains power quality should be that of a typical com­mercial or hospital environment. If the user of the AV151f requires continued operation during power mains interruptions, it is recommended that the AV151f be powered from an uninterruptible power supply or a battery.
levels characteristics of a typical loction in a typical
commerical or hospital enviroment.
Portable and mobile RF communications equipment should be used no closer to any part of the AV151f, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 800MHz to 2,5 GHz
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 xed RF transmitters, as determined by an electro­magnetic site survey, frequency range. Interference may occur in the vicinity of equipment marked with the fol­lowing symbol:
a
should be less than the compliance level in each
vv
Recommended separation distance between
The AV151f is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AV151f can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AV151f as recommended below, according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. NOTE1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from
portable and mobile RF communications equipment and the AV151f
Rated maximum output
power of transmitter (W)
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
structures, objects and people.
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz / d=1,2√P 80MHz to 800MHz / d=1,2√P 800MHz to 2,5GHz / d=2,3√P
www.rossmaxhealth.com
IN0AV151f000000XX
Issue date: 2011/05/03
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