Rossmax AC701k Instruction Manual

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 Na-
tional 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.
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.
Blood pressure measurements determined with AC701k 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. AC701k is protected against manufacturing defects by an established International Warranty Program. For warranty information, you can contact the manufacturer, Rossmax International Ltd.
1. Introduction
3. Digital Korotkoff Sound (DK) Technology
4. Preliminary Remarks
Digital Korotkoff Sound (DK) Technology is a combination of the Oscil­lometric Method and Korotkoff Sound Method. Supported with an ad­vanced dual-sensor cuff system (built-in pressure sensor plus sound sen­sor), the Rossmax DK Technology offers accurate analysis to the oscillation and K-sound, which perfectly integrates the convenience of Oscillometric Method and the expertise of the clinically trusted Korotkoff Sound Meth­od.
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 dated 14 June 1993 concerning medical devices: 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 auto-
mated non-invasive sphygmomanometers. This blood pressure monitor was designed for long service time. To ensure continued accuracy, it’s recommended that all digital blood pressure mon­itors require re-calibration. This monitor (under normal usage with approx.
3 measurements a day) does not require re-calibration for 2 years. Once
the unit should be re-calibrated the device will display
. The unit should also be re-calibrated if the monitor sustains damage due to blunt force (such as dropping) or exposure to uids and / or extreme hot or cold temperature / humid­ity changes. When appears, simply return to your nearest dealer for re-calibration service.
7. Display Explanations
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.
5. Blood Pressure Standard
6. Blood Pressure Fluctuation
11. 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 START/STOP 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.
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2. Name/Function of Each Part
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 mate-
rial 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.
The National High Blood Pressure Education Program Coordinating Com­mittee has developed a blood pres­sure standard, classifying blood pressure ranges into 4 stages. This unit is equipped with innova­tive blood pressure risk indicator, which visually indicates the as­sumed risk level (prehypertension / stage 1 hypertension / stage 2 hy­pertension) of the result after each measurement.
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.
12. Applying the Cuff
8. Hypertension Risk Indicator
9. Irregular Heartbeat Detector (IHB)
1.
Hypertension Risk Indicator
2.
Memory Zones
3.
Weak Battery Mark
4.
Memory Average
5.
Date/Time Indicator
6. Irregular Heartbeat Detector (IHB)
7. Systolic Pressure
8. Diastolic Pressure
9. Pulse Rate
10. Pulse Mark
Fig.1
Fig.3
Fig.2
Fig.4
Fig.5
Fig.7
Fig.6
1. Connect the AC adapter with the AC adapter jack in the
back of the unit.
2. Plug the AC adapter into the socket. (AC adapters with re­quired voltage and current indicated near the AC adapter
jack.)
Caution: 1. Please unload the batteries when operating
with the AC mode for a longer period of time Leaving the batteries in the compart­ment for a long time may cause leak­age, which may lead to damage of the unit.
2. No batteries are needed when
operating with the AC mode.
3. AC adapters are optional. Please contact the distributor for the
compatible AC adapters.
4. Use only the authorized AC Adaptor with this blood pressure
monitor.
10. Using the AC Adapter (Optional)
AC Adapter
(Ø3.8/Ø1.3)
Arm Cuff
Date/Time Set Key
LCD Display
User­Switching key
START/STOP key
Memory key
Air Tube and Connector
Battery Cover (Located on back of unit)
4“AA”(R06) size,
1.5V batteries.
Data Link Socket
AC Adapter Jack
1
2
3 4
5
6
7
8
9
10
Instruction Manual
Model: AC701 k
EN
CIRCLIFE
1. The monitor has two memory zones (1 and 2). Each zone can store up to
60 measurements.
2. To read memory values from a selected memory zone, use the User-Switch­ing key to select a memory zone (1 or 2) from which you want to recall
values. Press the Memory key. The first reading displayed is the average of the last 3 measurements stored in memory.
3. Continue to press the Memory key to view the last previously stored meas­urement. Every measurement comes with an assigned memory sequence number.
Note: The memory bank can store up to 60 readings per memory zone. When
the number of readings exceeds 60, the oldest data will be replaced with the new record.
14. Recalling Values from Memory
15. Clearing Values from Memory
16. Time Adjustment
17. Data Transfer to PC Ready
1. Press the User-Switching key to select memory zone 1 or memory zone 2.
2. Continue to press and hold the Memory key for approximately 5 seconds,
then the data in the pre-designated memory zone can be erased automati-
cally.
1. To adjust the date / time in the monitor, press the
key . The display will
show a blinking number showing the hour.
2. Change the hour by pressing the
key. Each press will increase the
number by one in a cycling manner. Press the
key again to confirm the
entry and the screen will show a blinking number representing the minute.
3. Change the minute and date as described in Step 2 above, using the
key to change and the
key to confirm the entries.
4. “0” will reappear as the Blood Pressure Monitor is ready for measurement
again.
Rossmax provides a free, integrated and user-friendly blood pressure management software which can be downloaded and installed on your computer. You may purchase a special designed USB cable in order to connect Rossmax’s blood pressure monitor and your PC. Please visit the website at http://www.rossmaxhealth.com for proceeding the download­ing and installation process.
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.
18. Troubleshooting
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 START/STOP 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.
19. Cautionary Notes
20. Specications
21. EMC guidance and manufacturer’s declaration
IN0AC701k000000XX
Issue date: 2011/05/03
www.rossmaxhealth.com
Measurement Method
Digit Arithemetic Waveform of Korotkoff Method and 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 60 memories for each zone x 2 zones 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
AC Power Source
DC12V, >600mA(Plug size: outer(-) is Ø3.8, inner(+) is Ø1.3) Dimensions 117 (L) X 123 (W) X 165 (H) mm Weight 535g (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
protection against electrical shocks.
*Specifications are subject to change without notice.
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 START/STOP 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.
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 User-Switching key to select memory zone 1 or memory zone 2. After a memory zone is selected, press the START/STOP key to reset the
monitor so it can start measurement in the chosen memory zone.
2. Press the START/STOP key. All digits will light up, checking the display func­tions. The checking procedure will be completed in 2 seconds.
3. After all symbols appear, the display will show a blinking “0”. The monitor is ready to measure and will automatically inflate the cuff slowly to start measurement.
4. When the measurement is completed, the cuff will exhaust the pressure inside. Systolic pressure, diastolic pressure and pulse will be shown simulta­neously on the LCD screen. The measurement is then automatically stored
into the pre-designated memory zone.
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 START/STOP or
Memory key; the cuff will deflate immediately.
3. During the measurement, do not talk or move your arm or hand
muscles.
13. Measurement Procedures
Guidance and manufacturer’s declaration-electromagnetic emissions
The AC701k is intended for use in the electromagnetic environment specied below. The customer or the user of the AC701k should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions CISPR 11 Group 1 The AC701k 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 AC701k 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 IEC 61000-3-2
Class A
Voltage uctuations/icker
emissions IEC 61000-3-3
Compliance
Guidance and manufacturer’s declaration-electromagnetic immunity
The AC701k is intended for use in the electromagnetic environment specied below.
The customer or the user of the AC701k 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
± 6 kV contact ± 8 kV air
± 6 kV contact ± 8 kV air
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast
transient/burst IEC
61000-4-4
± 2kV for power supply
lines
± 1kV for input / output
lines
± 2kV for power sup­ply lines
Not applicable
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000­4-5
± 1kV line(s) to line(s)
± 2kV line(s) to earth
± 1kV differential mode
Not applicable
Mains power quality should be that of a typical commercial or hospital environment.
Voltage Dips, short
interruptions and voltage variations
on power supply
input lines IEC 61000-4-11
<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
<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
Mains power quality should be that of a typical commercial or hospital environment. If the user of the AC701k requires continued operation during power mains interruptions, it is recom­mended that the AC701k be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) mag­netic eld IEC
61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at
levels characteristics of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration-electromagnetic immunity
The AC701k is intended for use in the electromagnetic environment specied below. The customer or the user of the AC701k 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
3 Vrms
150 KHz to 80 MHz
3 V/m 80MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the AC701k 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, a should be less than the compliance level in each frequency range.
b 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
reection from structures, objects and people.
a: Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the AC701k is used exceeds the applicable RF com­pliance level above, the AC701k should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AC701k.
b: Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the AC701k The AC701k is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AC701k can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AC701k as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter / W
Separation distance according to frequency of transmitter / m
150 kHz to 80 MHz / d=1,2√P 80 MHz to 800 MHz / d=1,2√P 800 MHz to 2,5 GHz / d=2,3√P 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
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
reection from structures, objects and people.
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.
CIRCLIFE
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