Nissei DS-10 - Digital Blood Pressure Monitor Manual

PARTS NAME AND PRODUCT COMPONENTS

1. MAIN UNIT

1. DISPLAY

2. MEMORY BUTTON

3. START/STOP BUTTON

4. AC ADAPTOR JACK

5. AIR CONNECTOR

2. CUFF

6. BATTERY COMPARTMENT
7. METAL RING
8. AIR HOSE i AIR PLUG

3. POUCH
4. AA (LR6) BATTERIES
5. INSTRUCTIONS
6. AC ADAPTOR (DS-10a only)

DISPLAYS

1. MEMORY BANK SYMBOL
2. BATTERY REPLACEMENT INDICATION
3. PULSE RATE MARK
4. BODY MOTION SYMBOL
5. IRREGULAR PULSE RHYTHM SYMBOL
6. INFLATION SYMBOL
7. DEFLATION SYMBOL
8. SYSTOLIC
9. DIASTOLIC
10. PULSE RATE

GENERAL INFORMATION

This manual is intended to assist you in the safe and efficient operation of BLOOD PRESSURE MONITOR DS-10/DS10a. The product must be used in accordance with the procedures contained in this manual and must not be used for purposes other than those described herein. It is important to read and understand the entire manual. In particular, please read carefully and become familiar with the section entitled "TIPS ON TAKING YOUR BLOOD PRESSURE".

INDICATIONS FOR USE

This product is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adults in a home healthcare environment. The product is not designed for neonatal use. Please consult with your doctor or physician to use this product to take blood pressure of child or person in pregnancy or under pre-eclamptic condition.

METHOD OF MEASUREMENT

This product employs the oscillometric method for measurement of blood pressure and pulse rate. The cuff is connected to the main unit and wrapped around the arm. Circuits within the cuff sense the small oscillations in pressure against the cuff produced by the expansion and contraction of the arteries in the arm in response to each heart beat. The amplitude of each pressure waves is measured, converted to millimeters of mercury, and displayed on the LCD as a digital value.

PRODUCT SPECIFICATIONS

*Accuracy is guaranteed with the measured values that are within the measuring range.

• This device complies with EN1060-1:1995+A2:2009 Non-invasive sphygmomanometers Part 1: General requirements and EN1060-3:1997+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring system.
• The measurement accuracy of the product has been proven according to ISO 81060-2 protocol. In the clinical study, K5 was used for the determination of diastolic pressure values at all auscultatory measurements.
• This product is intended for use in the environment with one atmospheric pressure.

Specifications are subject to change without notice due to improvements in performance.

PRECAUTIONS AND CONTRAINDICATIONS

• Do not use this product without consultation with your doctor if you are under dialysis therapy or on anticoagulants, antiplatelets or steroids. Use of this instrument under such conditions could cause internal bleeding.
• For specific information on your blood pressure, contact your physician. Never make any judgment on your own regarding measurement results.
• Do not use this product along with implantable and wearable medical electrical equipment such as pacemaker, defibrillator, or electrocardiographic monitor. This product is not also intended to be used with HF surgical equipment.
• Do not use this product in an explosive environment such as near flammable anesthetics or inside oxygen chamber.
• The system may fail to yield specified measurement accuracy if operated or stored in temperature or humidity conditions outside the limits stated in the specifications section of this manual.
• Do not use cuffs or accessories other than those specified by the manufacturer. Otherwise, correct measurement readings cannot be obtained.
• Use of this product in areas near mobile phones, microwave ovens or other devices with strong electromagnetic field may cause malfunctions.
• Do not apply the cuff over wounded arm, arm under an intravascular access or therapy or an arterio-venous shunt, or arm on the side of a mastectomy or lymph node clearance. Otherwise injury may be resulted.
• Make sure that inflation of the cuff is not causing prolonged impairment of blood circulation. Also, be cautious about temporary loss of the functions of any other medical equipment if any monitoring equipment is used on the same limb with the blood pressure measuring cuff.
• To avoid harmful injury due to interfered blood flow from cuff inflation,
  • Make sure that AIR HOSE is not kinking before measurement. Otherwise, cuff inflation may not be conducted properly and prolonged, and
  • Do not make measurements repeatedly.
• To avoid any possibility of accidental strangulation, keep this product away from children and do not drape AIR HOSE around your neck.
• The unit contains small parts and batteries which could be swallowed by children or pets. They should therefore be kept out of the reach of children and pets at all times.
• Because the product includes precision parts, avoid extreme temperature variations, humidity, shock, dust, lint, and direct sunlight. Do not drop or strike the product. Make sure not to expose it to moisture. This product is not water resistant.
• Do not press the display or place the unit with display face down.
• Do not take out batteries or unplug the AC adaptor when the unit is turned on. Make sure to switch off the unit before removing batteries or AC adaptor.
• Do not touch the output plug of AC adaptor during measurement.
• Do not disassemble or modify the product.
• Do not inflate the cuff when it is not wrapped around your arm.
• This product is not designed for self-use by unspecified persons in public areas.
• Do not apply the cuff on the limb which the intravenous drip infusion is implemented.
• Any serious incident occurred in relation to the device should be reported to the manufacturer and the competent authority in your country/area. If you have no contact information of such authority, please contact the manufacturer or EU authorized representative whose contact information is indicated in this instruction manual.

TIPS ON TAKING YOUR BLOOD PRESSURE

Blood pressure is the force exerted by the heart in pumping the blood through the arteries and the resistance by the veins in this flow.

Blood pressure varies all the time, influenced by mental and physical factors, and is never constant.

In general, blood pressure is highest during the working hours and gradually decreases during the afternoon and evening hours. It is low during sleep and increases at a relatively fast rate after arising from bed.

Causes for Changes in Blood Pressure

• Body movement
• Mental Tension
• Emotions
• Drinking Alcohol
• Recent Urination or Bowel Movement
• Conversation
• Nervousness
• Eating
• Smoking
• Room temperature
• Changes in the surroundings such as movement or noise, etc.

Blood pressure measured at home tends to be lower than when measured in a hospital, clinic or doctor's office. This is because you are tense at the hospital and relaxed at home. It is important to know your stable normal blood pressure at home.

Let a qualified physician interpret your blood pressure readings.

Depending on your age, weight and general condition, blood pressure can be slightly different. Consult with your doctor on determining what blood pressure is normal for you.

Before taking blood pressure, rest for approximately five minutes and take your blood pressure while relaxed in a quiet environment.
Measure blood pressure using the correct posture and do not move or speak during measurement.
Avoid exercise, eating, drinking alcohol, smoking and other activities that affect your blood pressure right before a measurement.
Take your blood pressure at the same time every day.
The ambient temperature should be approximately 20°C when you take your blood pressure. Reading may vary slightly, depending on posture, whether sitting or lying.

INSTALLING BATTERIES

1. OPENING THE BATTERY COMPARTMENT

Remove the cover of the battery compartment on the underside of the unit.

2. INSERTING BATTERIES

Install four "AA" type batteries into the compartment, observing proper polarity (marking in battery compartment).

3. CLOSING THE BATTERY COMPARTMENT

Close the battery compartment by clipping the battery cover back into the unit.

4. OPERATION WITH AC ADAPTOR

Connect the designated AC adaptor to the AC ADAPTOR JACK located at the right side of the unit. It is suggested to take out the batteries when using the adapter.

CONNECTING THE CUFF

Connect the AIR PLUG to the AIR CONNECTOR at the left side of the unit.

Accurate measurement is not possible if the AIR PLUG is unplugged or loose. Make sure that the AIR PLUG is inserted firmly.

WRAPPING THE CUFF

1. Place the cuff on your left arm with the air hose positioned toward your hand.
   
2. Wrap the cuff around your arm with the edge of the cuff approximately 2~3 cm above the elbow. AIR HOSE should be on the palm side of the arm.
   
3. Press the surface of the cuff to make sure that the hook & loop fastens securely.
   

When wrapping the cuff, wrap it loosely enough around the arm so that two fingers can be placed between the cuff and the arm. If the cuff is wrapped more tightly or loosely than this, inaccurate blood pressure readings may result.

If you are wearing a shirt that might restrict circulation in your upper arm or you roll your sleeve up over the upper arm, the blood flow will be restricted, preventing accurate measurement.

CORRECT MEASURING POSTURE

Sit at the table, let the chair and table support your back and arm, and keep your feet flat on the floor as you take the blood pressure measurement.

Make sure that the measurement location on the upper arm is at approximately the same height as the heart, and that the forearm is extended naturally on the table and does not move.

You may lie on your back and take the measurement. Look at the ceiling, stay calm, and do not move your neck or body during the measurement. Again, make sure that the measurement location on the arm is at approximately the same height as the heart.

Measured data may vary slightly depending on the posture during measurement. If the cuff is lower (higher) than the heart, the measured reading tends to become larger (smaller).

MAKING A MEASUREMENT

1. Press START/ STOP BUTTON.
   
2. After the full display appears and disappears, deflation mark flashes and the calibration is adjusted to the ambient air pressure.
   
3. Automatic inflation starts and inflation mark flashes.
   
4. Inflation mark disappears and measurement begins.
   
5. Heart mark flashes as pulse is detected.
   The unit automatically exhausts the air from the cuff as the measurement is complete.
   
6. Blood pressures and pulse rate are displayed.
   The reading is automatically saved in the bank.
   

Press START/STOP BUTTON to turn off the power.

If you forget to turn off the unit, it will be automatically turned off after 3 minutes.

To stop measurement
Press START/STOP BUTTON and inflation stops, air is exhausted, and unit turns off.

BODY MOTION SYMBOL

Blood pressure value taken while moving cannot be said to be the correct value because body movement can affect blood pressure.

This product analyzes pulse wave and displays [ ] when body motion is detected.

[] indicates the results might be affected by body movement.

IRREGULAR PULSE RHYTHM INDICATION

Pulse rhythm can be disturbed from talking, moving or regular pulse rhythm arrhythmias.

This product displays [], indicating irregular pulse rhythm.

Although continuous appearance of the indication under quiet An example of irregular pulse rhythm measurements may suggest arrhythmias, do not make any compared to regular pulse rhythm judgment on your own before consulting with your doctor.

Do not execute repeated measurements for congestion of blood could result in false measurement. Let your arm rest for at least 5 minutes.

CARE AND MAINTENANCE

Keep the product clean. Inspect its cleanliness after use. To clean, use only a soft dry cloth. Do not use gasoline, paint thinner, or other strong solvents. Since the cuff may absorb perspiration and other fluids, inspect it for stain and discoloration after each use.

When cleaning the cuff, use a synthetic detergent and gently rub the surface. Air dry thoroughly. Make sure fluid never gets in AIR HOSE. Do not machine wash or scrub it.

When storing the product, do not place heavy objects on it. Do not fold or bend the cuff forcibly. To disconnect the cuff from the main unit, do not pull AIR HOSE but hold AIR PLUG and unplug it. Do not coil AIR HOSE too tightly. In case the product is stored in the environment with ambient temperature above 40°C or below 10°C, please leave it for at least 2 hours before taking a measurement. Remove the batteries if the product is to be stored for an extended period of time. Keep the batteries out of reach of children.

Stop using the product immediately and contact your dealer or the manufacturer in case any visible damage is found on the unit.

We suggest that you have your blood pressure monitor checked every 2 years. This operation may only be performed by the manufacturer or by firms authorized by the manufacturer.

TROUBLESHOOTING

Blood pressure is extremely high or low.
Measurement is not taken with correct posture or the cuff is wrapped incorrectly.
Reconfirm the measurement procedures.
The reading was effected from moving or talking. Remain still and quiet during measurement.
Measurement was taken right after exercise or other activities influencing the reading. Measure again after resting for more than 5 minutes. See TIPS ON TAKING YOUR BLOOD PRESSURE.

Measured values vary all the time.
Mental and physical condition or measurement condition is influencing blood pressure. Make measurement under the same condition.

Measured value is different from that taken at a hospital.
Mental condition such as nervousness at a hospital or relaxed feeling at home is influencing blood pressure. Take records of blood pressure taken at home and consult with your doctor.

Blood pressure is changing 24 hours a day in relation with mental and physical conditions. Eating, drinking, smoking, exercising or bathing will alter blood pressure. Blood pressure will be also influenced by mental condition such as feeling tensed or relieved and health condition It is important to know the tendency of blood pressure by making measurement regularly. Make your own rules including conditions and time to make measurement and take blood pressure everyday.

[Err 300] is displayed.
Over pressure: blood pressure could not be taken due to moving or speaking although the cuff was inflated to the maximum pressure. Do not move or speak during measurement.

[Err -1] is displayed.
Blood pressure could not be taken due to moving or speaking. Do not move or speak during measurement.

[Err -2] is displayed.
The cuff is not securely connected to the unit. Secure the air connector.
The cuff is not wrapped appropriately. Reconfirm how to put the cuff on your arm.

[ ] is displayed.
Batteries are weak. Replace all batteries with new ones.

Nothing is displayed.
Batteries are depleted. Replace all batteries with new ones.
Batteries are inserted incorrectly. Reinsert the batteries correctly.
Battery terminals are not clean. Clean the terminals with dry cloth. AC adaptor is not connected. Connect AC adaptor.

[0 0] is displayed.
"START/STOP" BUTTON was being pressed when batteries are being installed or when AC adaptor is being plugged in. Turn off the unit once with "START/STOP" BUTTON.

Cuff end is loosened.
Put the cuff with its hook and loop fastener side down. Put the cuff end through the metal ring. Fold back the cuff at the metal ring.

If you cannot get correct measurement with the methods above, contact your dealer. Do not disassemble or tamper with the internal mechanism.

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