Medline MDS3003 User manual

MDS3003 MDS3003P
AUTOMATIC WRIST BLOOD
PRESSURE UNIT
(ELECTRONIC SPHYGMOMANOMETER)
OPERATION GUIDE
Read all of the information in the operation guide and
any other literature in the box before operating the unit.
V3 RE22AXA

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Important Information 3
Contents And Display Indicators 4
Intended Use 5
Contraindication 5
Product Description 6
Specifications 7
Notice 8
Setup And Operating
Procedures 14
1. Battery Loading 14
2. Clock And Date Adjustment 14
3. Connecting The Cuff To The Monitor 16
4. Applying The Cuff 16
5. Body Posture During Measurement 17
6. Taking Your Blood
Pressure Reading 18
7. Displaying Stored Results 19
8. Deleting Measurements
From The Memory 21
9. Assessing High Blood Pressure
For Adults 21
Troubleshooting (1) 23
Troubleshooting (2) 24
Maintenance 26
Explanation Of Symbols On Unit 28
Warranty Information 29
Service Center 29
Electromagnetic
Compatibility Information 30
CONTENTS

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IMPORTANT INFORMATION
NORMAL BLOOD PRESSURE FLUCTUATION
All physical activity, excitement, stress, eating, drinking, smoking, body posture and
many other activities or factors (including taking a blood pressure measurement) will
influence blood pressure value. Because of this, it is mostly unusual to obtain identical
multiple blood pressure readings.
Blood pressure fluctuates continually day and night. The highest value usually appears
in the daytime and the lowest one usually at midnight. Typically, the value begins to
increase at around 3:00 AM, and reaches the highest level in the daytime while most
people are awake and active.
Considering the above information, it is recommended that you measure your blood
pressure at approximately the same time each day.
Please always relax a minimum of 1 to 15 minutes between measurements to allow the
blood circulation in your arm to recover. It is rare that you obtain identical blood pressure
readings each time.

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CONTENTS AND DISPLAY INDICATORS
•1 Blood Pressure Monitor with Attached Wrist Cuff •1 Operation Guide •1 Soft Storage Case

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Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or
at home and is a non-invasive blood pressure measurement system intended to measure
the diastolic and systolic blood pressures and pulse rate of an adult individual by using a
non-invasive technique in which an inflatable cuff is wrapped around the wrist.
It is inappropriate for people with serious arrhythmia to use this Electronic
Sphygmomanometer.
INTENDED USE
CONTRAINDICATION
•1 Blood Pressure Monitor with Attached Wrist Cuff •1 Operation Guide •1 Soft Storage Case

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Based on Oscillometric methodology and silicon integrated pressure sensor, blood
pressure and pulse rate can be measured automatically and non-invasively. The LCD
display will show blood pressure and pulse rate. The most recent 1 X 60 measurements
can be stored in the memory with date and time stamp. The monitor can also show the
average reading of the last three measurements. The Electronic Sphygmomanometer
corresponds to the below standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/
A1:2013 (Medical electrical equipment -- Part 1: General requirements for basic safety
and essential performance), IEC60601-1-2:2014/EN 60601-1-2:2015(Medical electrical
equipment -- Part 1-2: General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC80601-
2-30:2009+AMD1:2013/EN 80601-2-30:2010/A1:2015(Medical electrical equipment
–Part 2-30: Particular requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers)EN 1060-1: 1995 + A2: 2009 (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);ISO81060-2:2013(Non-Invasive
Sphygmomanometers - Part 2:Clinical Validation Of Automated Measurement Type).
PRODUCT DESCRIPTION

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1. Product name: Blood Pressure Monitor
2. Model: MDS3003/MDS3003P
3. Classification: Internally powered,Type BF applied part, IP22, No AP or APG,
Continuous operation
4. Machine size: 83mm x 64mm x 28mm (3 1/4” x 2 17/32” x 1 3/32”)
5. Cuff circumference: 14cm - 19.5cm (5 1/2” - 7 11/16”),
6. Weight: approx. 110g (3 7/8oz.) (excludes batteries)
7. Measuring method: oscillometric method, automatic air inflation and measurement
8. Memory volume: 60 times with time and date stamp
9. Power source: 2 × 1.5V ⎓ SIZE AAA batteries
10. Cuff pressure: 0-300mmHg
11. Range of measurement:
Systolic: 60-260mmHg
Diastolic: 40-199mmHg
Pulse rate: 40-180 beats/minute
12. Measuring accuracy: ±3mmHg
13. Pulse rate range: ±5% precision of the displayed values: 1mmHg
SPECIFICATIONS

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NOTICE
14. Environmental temperature for operation: 5ºC~40ºC (41ºF~104ºF)
15. Environmental humidity for operation: ≤90% RH
16. Environmental temperature for storage and transport: -20ºC~55ºC (-4ºF~131ºF)
17. Environmental humidity for storage and transport: ≤90% RH
18. Environmental pressure: 80KPa-105KPa
19. Battery life: Approx. 270 measurements.
20. List of all components belonging to the pressure measuring system, including
accessories: Pump, Valve, LCD, Cuff, Sensor
1. The patient is an intended operator.
2. The blood pressure monitor is not intended to exposed to the Electromagnetic
Interference (EMI)environment, please do not use the blood pressure monitor
within the environment of the following device: Magnetic Resonance Imaging (MRI),
computerized axial tomography (CT), diathermy, Radio Frequency Identification
(RFID), and electromagnetic security systems such as metal detectors.
MR

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3. This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
4. Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the
batteries and the unit out of the reach of children and disabled persons.
5. If you are allergic to plastic/rubber, please don’t use this device.
6. Do not use this unit in a moving vehicle. This may result in erroneous measurement.
7. Too frequent measurements may cause injury due to blood flow interference.
8. —Motion, trembling, shivering may affect the measurement reading.
—Consult your physician before using the device for any of the following conditions:
common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
arterial sclerosis, poor perfusion, diabetes, pre-eclampsia, renal diseases.
9. The device is not intended for use on neonates, children or pregnant women. (Clinical
testing has not been conducted on neonates, children or pregnant women.)
10. Keep still, calm and rest for 5 minutes before blood pressure measurement.
11. The cuff should be placed at the same level as your heart.

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12. During measurement, neither speak nor move your body and arm.
13. Measure on the same wrist each measurement.
14. Consult with your physician for any of the instances below:
—This device does not measure circulation or blood flow.
—The application of the cuff is over a wound or inflammation.
—The application limb shares intravascular access or therapy, or an arteriovenous
(A-V) shunt.
—The application arm is on the same side as a mastectomy or lymph node
clearance.
—The application limb shares monitoring equipment.
15. Please always relax a minimum of 1 to 15 minutes between measurements to allow
the blood circulation in your arm to recover. Prolonged over-inflation (cuff pressure
exceeding 300 mmHg or maintained above 15 mmHg for longer than 3 minutes) of
the bladder may cause ecchymoma of your arm.
16. Remove the batteries if the monitor will not be used for a month or more to avoid
damage caused by battery leakage.
17. This Electronic Sphygmomanometer is designed for adults and should never be