Nissei DS-10a - User Manual

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Overview

Function Description
Important Technical Specifications
Usage Features
Maintenance Features
Warranty

The NISSEI DS-10/DS-10a is a digital blood pressure monitor designed for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adults within a home healthcare environment. It employs the oscillometric method for measurement.

Function Description:

The device measures blood pressure by sensing small oscillations in pressure against the cuff, produced by the expansion and contraction of arteries in the arm with each heartbeat. The amplitude of these pressure waves is measured, converted to millimeters of mercury, and displayed digitally on an LCD. Key features include "Measurement on inflation" technology, which defines pressure during cuff inflation, an "Irregular Pulse Rhythm indicator" to inform of irregular heartbeats while ensuring correct measurement results, and a "Body motion indicator" that adapts the measurement algorithm based on previous results. The device automatically inflates the cuff and displays systolic pressure, diastolic pressure, and pulse rate. Readings are automatically saved.

Important Technical Specifications:

Operating Principle: Oscillometric method.
Indicator: 9 digits liquid crystal display.
Pressure Indicating Range: 0 to 300 mmHg (cuff pressure).
Measuring Range:
- Cuff pressure: 40 to 250 mmHg.
- Pulse rate: 40 to 180 mmHg.
Accuracy:
- Cuff pressure: ±3 mmHg.
- Pulse rate: ±5%.
Cuff: Cuff DS-10.
Cuff size: 22-32 cm.
Operation Conditions:
- Temperature: 10 to 40 °C.
- Relative humidity: 15 to 85 % Rh.
Storage and Transportation Conditions:
- Temperature: -20 to 60 °C.
- Relative humidity: 15 to 85 % Rh.
Power Supply: 6 V.
Inflation: Automatic (air pump, Measurement on Inflation).
Deflation: Automatic.
Type of Power Supply: 4 "AA" size batteries (LR6) or adapter not less than 600 mA.
AC Adaptor ADP-W5 (included in DS-10A):
- Output voltage: 6 V.
- Max load current: 0.5 A.
- Input voltage: 100-240/50 V/Hz.
Dimension: 120x125x70 mm.
Weight (without batteries and adapter): 345 g.
Protection Class IP: IP20 (Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against water).
Protection against electric shock: Internally powered equipment/Class II equipment, Type BF applied part.
Mode of Operation: Continuous operation.
Classification: Class II / Internally powered equipment.
Compliance: EN1060-1:1995+A2:2009, EN1060-3:1997+A2:2009, ISO 81060-2 protocol, IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, Directive 93/42/EEC.

Usage Features:

Power Supply: Can be powered by four "AA" batteries or an AC Adaptor (ADP-W5 for DS-10a). When the battery replacement indicator flashes, all batteries should be replaced. If the indicator steadily flashes upon turning on, measurement is not possible until batteries are replaced. Alkaline batteries are recommended for longer operation.
Cuff Application: Apply the cuff to the left upper arm (or right if necessary, noting potential reading differences) so the air hose points to the palm. The bottom of the cuff should be 2-3 cm above the elbow. Ensure the cuff fits tightly but not overtight, and is not too loose, to avoid inaccurate readings. For cone-shaped arms, apply the cuff spirally. Rolled-up sleeves should not squeeze the arm, as this can interfere with blood flow and lead to inaccurate readings.
Measurement Position: Sit with your back supported and feet flat on the floor. The cuff on the upper arm should be at approximately the same level as the heart. The forearm and hand should rest freely on the table without moving. Measurements can also be taken while lying on your back, ensuring the cuff is at heart level. Movement or talking during measurement can affect accuracy.
Measurement Procedure:
1. Insert the Air Plug into the Air connector.
2. Press the START/STOP button. The screen will briefly display all characters, then the previous measurement result, and release any remaining air from the cuff. If batteries were just installed, only the release symbol will appear.
3. Rapid air injection into the cuff will begin, indicated by a flashing "▲" symbol and increasing pressure value.
4. The "▲" symbol will disappear, and measurement will start as cuff pressure slowly increases.
5. A heart mark will flash as pulse is detected.
6. The unit automatically exhausts air from the cuff once measurement is complete.
7. Blood pressure and pulse rate are displayed and automatically saved.
8. Press the START/STOP button to turn off the device. It will automatically turn off after 3 minutes if forgotten.
Recommendations for Correct Measurements:
- Consult a doctor if undergoing hemodialysis, or taking anticoagulants, antiplatelets, or steroids.
- Avoid using the device near mobile phones, microwave ovens, or other electromagnetic radiation-generating equipment.
- Blood pressure fluctuates; measure at room temperature (about 20°C). If stored outside operational temperature range, allow 2 hours to acclimatize.
- Remain quiet and still during measurement. Avoid meals an hour before, and smoking, soft drinks, or alcohol 1.5-2 hours before.
- Ensure the cuff size matches your arm.
- Allow 5-minute intervals between repeated measurements (10-15 minutes for severe atherosclerosis or long-term diabetes). Take three consecutive measurements and average the results for accuracy.
- Do not use in explosive environments or near flammable anesthetics/oxygen chambers.
- Do not operate or store outside specified temperature/humidity limits.
- Use only manufacturer-specified cuffs and accessories.
- Do not apply the cuff over wounded arms, intravascular access, arterio-venous shunts, or on the side of a mastectomy/lymph node clearance.
- Ensure cuff inflation does not cause prolonged impairment of blood circulation or temporary loss of function of other medical equipment on the same limb.
- Ensure the air hose is not kinked.
- Do not remove batteries or unplug the AC adaptor while the device is on.
- Do not touch the AC adaptor output plug during measurement.
- Do not inflate the cuff if not wrapped around the arm.
- Do not apply the cuff on a limb with intravenous drip infusion.
- Do not perform several measurements in a row; allow at least 5 minutes between measurements to prevent arm numbing and inaccurate results.
- Do not press the display or place the device face down.
- Keep small parts and batteries out of reach of children and pets.
- Not designed for self-use by unspecified persons in public areas.
- Report any serious incidents to the manufacturer and competent authority.

Maintenance Features:

Protection: Protect from excessive moisture, extreme temperature variations, direct sunlight, strokes, dust, lint, and vibration. The device is not waterproof.
Storage: Do not keep or use near heaters or open flame. If stored outside 10-40°C, allow 2 hours to acclimatize before use.
Battery Removal: Remove batteries if the device will not be used for a long time to prevent damage from leakage.
Cleaning: Clean with a dry, soft cloth. Do not use water, solvents, alcohol, gasoline, or paint thinner. The cuff's internal fabric surface can be treated with a cotton swab moistened in a 3% hydrogen peroxide solution. Partial discoloration of the cuff may occur over time. Do not wash the cuff or treat it with a hot iron.
Cuff Care: Keep the cuff away from sharp objects and do not try to pull it out.
Handling: Do not expose the device to strong strokes or throw it.
Repair: The device contains no user-adjustable controls. Unauthorized opening of the electronic device is forbidden. Repairs should only be performed by specialized organizations.
Disposal: Follow national/local regulations for waste recycling for both the device and batteries.
Periodic Check: Refer to specialists periodically to check the technical condition of the device.
Unattended Use: Do not leave the device plugged into the network unattended.
Damage: Stop using immediately and contact the dealer or manufacturer if any visible damage is found.
Strangulation Hazard: Keep away from children and do not drape the air hose around the neck.

Warranty:

The manufacturer provides a 5-year warranty for the device, provided operation, transportation, and storage requirements are met. The cuff and AC Adaptor have a 12-month warranty. Warranty liabilities are documented with a certificate upon sale and are valid if the device has not been opened or damaged by the buyer.