Rossmax MS 400i User manual

Automatic Upper Arm Blood Pressure Monitor
Model: MS 400 i
Superior Accuracy
2 Users Up to
120 Memories
with Date/ Time Stamp
Irregular Heartbeat
Detector
Latex-Free Patented
Cone Cu
Hypertension
Risk Indicator
EN Instruction Manual. ..............2-12
UA Instruction Manual. ...........13-20
RU Instruction Manual. ...........21-28
RO Instruction Manual. ...........29-36
LT Instruction Manual. ...........37-44
LV Instruction Manual. ...........45-52
EE Instruction Manual. ...........53-60
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EN - 2
Introduction
Blood pressure measurements determined with this unit are equivalent to those obtained by
a trained observer using cu/stethoscope auscultation method, within the limits prescribed
by the American National Standard Manual, 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.
This unit is protected against manufacturing defects by an established International War-
ranty Program. For warranty information, you can contact the manufacturer, Rossmax Inter-
national Ltd. or your local distributors.
Attention: Consult the accompanying documents.
Please read this manual carefully before use, for specific information on your own blood
pressure, contact your physician. Please be sure to keep this manual.
Arm Cu
Date/Time Set Key LCD Display
User-Switching 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
Name/Function of Each Part
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 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 automated non-invasive
sphygmomanometers.
This blood pressure monitor was designed for long service time. To ensure continued
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accuracy, it's recommended that all digital blood pressure monitors require re-calibration.
This monitor does not require re-calibration for 2 years under normal usage with
approximately 3 times a day, until, at which time your monitor displays CA . The unit should
also be re-calibrated if the monitor sustains damange due to blunt force (such as dropping)
or exposure to uids and / or extreme hot or cold temperature / humidity changes. When CA
appears, simply return to your nearest dealer for re-calibration service.
Blood Pressure Standard
The National High Blood Pressure Education Program Coordinating Committee has de-
veloped 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 dif-
ferent people and different age groups...etc.
(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 regu-
larly. Your physician will tell you your normal blood pressure
range as well as the point at which you will be considered at
risk.
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 hyper-
tension) of the result after each measurement. (Please note below.)
Display Explanations
1. Date/Time Indicator
2. Hypertension Risk Indicator
3. Memory Zones
4. Memory Average
5. Memory Sequence Number
6. Weak Battery Mark
7. Irregular Heartbeat (IHB) Detector
8. Systolic Pressure
9. Diastolic Pressure
10. Pulse Rate
11. Pulse Mark
2
3
6
18
9
10
11
7
4
5
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Irregular Heartbeat (IHB) Detector
This unit is equipped with an Irregular Heartbeat (IHB) Detector which allows those who
have an irregular heartbeat to obtain accurate measurements alerting the user of the pres-
ence of an irregular heart beat during the measurement.
Note: It is strongly recommended that you consult your physician if the IHB icon (IHB) appears
often.
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 compart-
ment 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. As the supplied batteries are for test only, they may be discharged earlier than batteries you
buy in stores. 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.
Using the AC Adapter
1. Connect the AC adapter with the AC adapter jack in the back of the unit.
2. Plug the AC adapter into the socket. Please use the compatible AC adapters. (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.
2. AC adapters are optional. Please contact the distributor for the compatible AC adapters.
3. Use only the authorized AC Adaptor with this blood pressure monitor. Information for the
authorized AC adaptor, please refer to APPENDIX 1.
Applying the Cu
1. Unwrap the arm cu, leaving the end of the cu through the D-ring of the cu.
2. Put your left arm through the cu loop. The color strip indication should be positioned
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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 cu at approximately 1.5 to 2.5 cm above the inner
side of the elbow joint. Tighten the cu by pulling the end of the cu.
Fig.1
Fig.2
Fig.3
Fig.4
Fig.6 Fig.7
Fig.5
3. Center the tube over the middle of the arm. Press the hook and loop material together
securely. Allow room for 2 ngers to t between the cu 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 ngers 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 cu 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 cu 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 cu with other
circumferences. Contact your local dealer for additional size cus.
Measurement Procedures
Important Notes:
Here are a few helpful tips to help you obtain more accurate readings:
• Blood pressure changes with every heartbeat and is in constant uctuation throughout the
day.
• Blood pressure recording can be aected 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 caeine, or smoking to measure blood pressure.
• Before measurement, it’s suggested that you sit quietly for 15 minutes as measurement
taken during a relaxed state will have greater accuracy. You should not be physically tired or
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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 about 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 inate the cu slowly to start measurement.
4. When the measurement is completed, the cu 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-inate 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 o approximately 1 minute after last key opera-
tion.
2. To interrupt the measurement, simply press the START/STOP or Memory key; the cu
will deate immediately.
3. During the measurement, do not talk or move your arm or hand muscles.
Recalling Values from Memory
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
rst 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.
Clearing Values from Memory
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
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the pre-designated memory zone can be erased automatically.
Time Adjustment
1. To adjust the date/ time in the monitor, press the Time-set key. The display will show a
blinking number showing the month.
2. Change the month by pressing the“+”key. Each press will increase the number by one in a
cycling manner. Press the Time-set key again to conrm the entry, and the screen will show
a blinking number representing the date.
3. Change the date, the hour, and the minute as described in Step 2 above, using the“+” key
to change and the Time-set key to conrm the entries.
4.“0” will reappear as the Blood Pressure Monitor is ready for measurement again.
Data Transfer to PC Ready (Optional)
Accessories for data transfer to PC including:
1. BP MANAGER software CD-ROM
2. connecting cable (USB)
3. instruction manual
are packaged and sold separately from the blood pressure monitor.
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 cu 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 cu. 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 o 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 oc-
curring, 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 po-
sitions.
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.
Cautionary Notes
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1. The unit contains high-precision assemblies. Therefore, avoid extreme temperatures, hu-
midity, 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 cu carefully with a slightly damp, soft
cloth. Do not press. Do not wash the cu 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 eld 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 In-
ternational Ltd.
7. For users diagnosed with common arrhythmia (atrial or ventricular premature beats or
atrial brillation), diabetes, poor circulation of blood, kidney problems, or for users suered
from stroke, or for unconscious users, the device may have diculty in determining the
proper blood pressure.
8. To stop operation at any time, press the START/STOP key, and the air in the cu will be rap-
idly exhausted.
9. Once the ination reaches 300 mmHg, the unit will start deating rapidly for safety rea-
sons.
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. Meas-
urement 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 health-
care professional.
12. Electromagnetic interference: The device contains sensitive electronic components. Avoid
strong electrical or electromagnetic elds 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 specication if stored or used outside tem-
perature and humidity ranges specied in Specications.
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Specications
Measurement Method : Oscillometric
Measurement Range : Pressure: 40~250mmHg; Pulse: 40~199 beats/ minute
Pressure Sensor : Semi conductor
Accuracy : Pressure: ±3mmHg; Pulse: ±5% of reading
Ination : Pump Driven
Deation : Automatic Pressure Release Valve
Memory capacity : 60 memories for each zone x 2 zones
Auto-shut-o : 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 : DC 12V, ≥ 600mA (Plug size: outer(-) is Ø3.8, inner(+) is Ø1.3)
Dimensions : 155 (L) X 110 (W) X 75 (H) mm
Weight : 430g (G.W.) (w/o Batteries)
Arm circumference : 24~36 cm (9.4”~14.2”)
Limited users : Adult users
: Type BF : Device and cu are designed to provide special protec-
tion against electrical shocks.
*Specications are subject to change without notice.
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EMC guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration-electromagnetic emissions
The MS400i is intended for use in the electromagnetic environment specied below.
The customer or the user of the MS400i should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions CISPR 11 Group 1 The MS400i 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 MS400i 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 pur-
poses.
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 MS400i is intended for use in the electromagnetic environment specied below.
The customer or the user of the MS400i should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guid-
ance
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 tran-
sient/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 environ-
ment.
Surge IEC 61000-4-5 ± 1kV line(s) to line(s)
± 2kV line(s) to earth
± 1kV dierential mode
Not applicable Mains power quality should be that of a typical commercial or hospital environ-
ment.
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 environ-
ment. If the user of the MS400i requires
continued operation during power mains
interruptions, it is recommended that the
MS400i be powered from an uninterrupt-
ible power supply or a battery.
Power frequency
(50/60 Hz) mag-netic
eld IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should
be at levels characteristics of a typical lo-
cation in a typical commercial or hospital
environment
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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