GIMA Talking Automatic Blood Pressure Monitor

Important Information

Normal Blood Pressure Fluctuation: Blood pressure fluctuates continually day and night. Factors such as physical activity, excitement, stress, eating, drinking, smoking, and body posture influence blood pressure values. It is unusual to obtain identical multiple readings. Typically, the highest value appears in the daytime, and the lowest at midnight. Values tend to increase around 3:00 AM and reach their peak during active daytime hours. It is recommended to measure blood pressure at approximately the same time each day. Allow 1 to 1.5 minutes between measurements for arm circulation to recover.

Contents and Display Indicators

The LCD display shows systolic pressure, diastolic pressure, and pulse rate.

[LCD display showing example readings: Systolic, Diastolic, Pulse. Also shows symbols for irregular heartbeat, low battery, unstable cuff pressure/air in cuff, and error.]

Components: Cuff, Cuff tube plug, Rubber tube.

Display Indicators:

• ♥: Irregular heartbeat symbol
• ?: Low battery
• ❗: Cuff pressure is unstable, or there is remnant air in the cuff.
• ❗: Find an error, please re-inflate.

Other Indicators: Memory, Start, LCD, Blood pressure level classification indicator.

Intended Use

This Fully Automatic Blood Pressure Monitor is designed for use by medical professionals or at home. It is a non-invasive system for measuring diastolic and systolic blood pressures and pulse rate in adult individuals. It uses an inflatable cuff wrapped around the upper arm. The cuff circumference range is 22cm-48cm (approx. 8 21/32"-18 29/32").

Contraindication

⚠️ It is inappropriate for people with serious arrhythmia to use this electronic blood pressure monitor.

Product Description

The monitor utilizes Oscillometric methodology and a silicon integrated pressure sensor for automatic, non-invasive measurement of blood pressure and pulse rate. The LCD displays these values. It stores the most recent 60 measurements with date and time stamps. The voice function enhances operation. The Electronic Blood Pressure Monitor complies with the following standards:

• IEC 60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2:2007/EN 60601-1-2:2007/AC:2010 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
• EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements)
• EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems)
• ANSI/AAMI SP-10:2002+A1:2003+A2:2006

Specifications

1. Product name: Blood Pressure Monitor
2. Model: KD-595
3. Classification: Internally powered, Type BF applied part, IPX0, No AP or APG, Continuous operation
4. Machine size: approx. 135mm x 108mm x 60mm (6 1/32" x 4 1/4" x 2 3/8")
5. Cuff circumference: 22-30 cm (8 21/32" -11 13/16"); 30-42cm (11 13/16"-16 17/32") (optional); 42-48 cm(16 17/32"-18 29/32") (optional)
6. Weight: approx. 290g (10 7/32 oz.) (excluding batteries)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 60 times with time and date stamp
9. Power source: DC 6V 600mA, batteries: 4 ×1.5V SIZE AA
10. Measurement range:
    • Cuff pressure: 0-300 mmHg
    • Systolic: 60-260 mmHg
    • Diastolic: 40-199 mmHg
    • Pulse rate: 40-180 beats/minute
11. Accuracy:
    • Pressure: ±3 mmHg
    • Pulse rate: ±5%
12. Environmental temperature for operation: 5°C~40°C (41°F~104°F)
13. Environmental humidity for operation: ≤90%RH
14. Environmental temperature for storage and transport: -20°C~55°C (-4°F~131°F)
15. Environmental humidity for storage and transport: ≤90% RH
16. Environmental pressure: 80kPa-105kPa
17. Battery life: Approx 180 times
18. Components: Pump, Valve, LCD, Cuff, Sensor

Note: These specifications are subject to change without notice.

Notice

1. Read all information in the operation guide and any other literature before operating.
2. Stay quiet, calm, and rest for 5 minutes before measurement.
3. Place the cuff at the same level as your heart.
4. During measurement, do not speak, move your body, or arm.
5. Measure on the same arm for each reading.
6. Relax at least 1 or 1.5 minutes between measurements for arm circulation recovery. Prolonged over-inflation (cuff pressure >300 mmHg or maintained above 15 mmHg for >3 minutes) may cause ecchymoma.
7. This monitor is designed for adults and should not be used on infants or young children. Consult a physician for use on older children.
8. Do not use in a moving vehicle, as this may result in erroneous measurements.
9. Measurements are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within ANSI limits.
10. For information on potential electromagnetic or other interference, see ELECTROMAGNETIC COMPATIBILITY INFORMATION.
11. If an Irregular Heartbeat (IHB) is detected, a ♥ symbol will be displayed. The monitor may continue to function, but results might be less accurate. Consult your physician for assessment. IHB is indicated by: 1) Coefficient of variation (CV) of pulse period >25%, or 2) Difference of adjacent pulse period ≥0.14s, and such pulses constitute >53% of the total.
12. Use only the supplied cuff to avoid biocompatible hazards and measurement errors.
13. The monitor may not meet performance specifications or cause safety hazards if stored or used outside specified environmental ranges.
14. Do not share the cuff with infective persons to avoid cross-infection.
15. Medical AC adapter output must be DC 6.0V 600mA and comply with IEC 60601-1/EN 60601-1/UL 60601-1 and IEC 60601-1-2/EN 60601-1-2/UL 60601-1-2. Monitor jack size: hole Ø 5.5mm, center pin Ø 2.0mm. Pay attention to polarity.
16. This equipment has been tested and found to comply with Class B digital device limits per FCC Rules Part 15. These limits provide reasonable protection against harmful interference in residential installations. The equipment generates, uses, and can radiate RF energy. If interference occurs, try correcting it by: reorienting/relocating the receiving antenna, increasing separation between equipment and receiver, connecting to a different circuit, or consulting a dealer/technician.
17. This blood pressure monitor is verified by auscultatory method. Refer to ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details.

Setup and Operating Procedures

1. Battery Loading

a. Open the battery cover at the back of the monitor.

b. Load four "AA" size batteries, observing polarity.

c. Close the battery cover.

?: When the LCD shows the battery symbol, replace all batteries with new ones.

Rechargeable batteries are not suitable. Remove batteries if the monitor will not be used for a month or more to prevent leakage damage.

⚠️ Avoid battery fluid contact with eyes. If contact occurs, rinse immediately with plenty of clean water and consult a physician.

The monitor, batteries, and cuff must be disposed of according to local regulations.

[Diagram showing the back of the monitor with the battery compartment open, illustrating the placement of four AA batteries.]

2. Clock and Date Adjustment

a. After installing batteries or turning off the monitor, it enters Clock Mode, displaying time and date.

b. In Clock Mode, press "START" and "MEM" simultaneously for two seconds. The month blinks first. Press "START" repeatedly to cycle through day, hour, and minute. Press "MEM" to increase the blinking number. Holding "MEM" increases the number faster.

[Diagrams showing the LCD display changing during the clock setting process, highlighting blinking month, day, hour, and minute.]

c. Press "START" when the minute is blinking to confirm time and date and turn off the monitor.

d. The monitor turns off automatically after 1 minute of inactivity, retaining the set time and date.

e. Readjust the time and date after changing batteries.

3. Voice Setting

a. In clock mode, press and hold the "MEM" button to select the voice language. The LCD will cycle through language codes (e.g., "LO" for voice off, "L1" for language 1, "L2" for language 2, etc.). Release "MEM" when the desired language code is displayed.

b. If only one language is available, the LCD will twinkle "ON" (voice on) and "--" (voice off).

c. To set voice volume, press and hold "MEM" again after selecting a language. A column of bars on the left of the LCD indicates volume level. Release "MEM" at the desired volume.

[Diagrams showing the LCD display during voice language selection and volume adjustment.]

4. Connecting the Cuff to the Monitor

Insert the cuff tubing connector into the socket on the left side of the monitor. Ensure it is fully inserted to prevent air leakage during measurements.

[Diagram showing the cuff tubing connector being inserted into the monitor's side socket.]

5. Applying the Cuff

a. Thread the cuff end through the metal loop, turn it outward (away from your body), tighten, and secure with the Velcro fastener.

b. Place the cuff around a bare arm, 1-2 cm above the elbow joint.

c. While seated, place your palm facing up on a flat surface like a desk or table. Position the air tube in the middle of your arm, aligned with your middle finger.

d. The cuff should fit comfortably but snugly. You should be able to insert one finger between your arm and the cuff.

[Diagram showing the correct placement of the cuff on the arm, indicating 1-2 cm above the elbow and the air tube position.]

6. Body Posture During Measurement

Sitting Comfortably Measurement:

• Sit with feet flat on the floor, legs uncrossed.
• Place palm facing up on a flat surface (desk or table).
• The middle of the cuff should be level with the right atrium of the heart.

Lying Down Measurement:

• Lie on your back.
• Place your arm straight along your side with your palm facing up.
• The cuff should be placed at the same level as your heart.

[Diagrams illustrating correct sitting and lying down postures for measurement, showing arm position and cuff height relative to the heart.]

7. Taking Your Blood Pressure Reading

a. After applying the cuff and assuming a comfortable posture, press the "START" button. A beep indicates a self-test, and all display characters appear. Check the LCD display.

[Diagram showing the LCD display during the self-test phase, with all segments illuminated.]

b. If results are stored, the most recent one is displayed momentarily. If no results are stored, "0" appears.

c. If the voice function is on, the monitor will provide measurement tips.

d. The monitor inflates the cuff until sufficient pressure is built up for measurement.

e. The monitor slowly releases air and performs the measurement.

f. Finally, blood pressure and pulse rate are calculated and displayed. The blood pressure classification indicator and irregular heartbeat symbol (if any) will blink. The voice function announces the result if enabled. The result is automatically stored.

g. After measurement, the monitor turns off automatically after 1 minute of inactivity. You can press "START" to turn it off manually.

h. During measurement, you can press "START" to turn off the monitor manually.

Note: Consult a healthcare professional for interpretation of pressure measurements.

[Diagrams showing example LCD displays during and after measurement, including BP values, pulse, and symbols.]

8. Displaying Stored Results

a. In Clock Mode, press the "MEM" button. The last result, with date and time, is displayed. The irregular heartbeat symbol and blood pressure classification indicator will blink. Press "MEM" repeatedly to review previous results.

b. If the voice function is on, each result in memory will be announced.

c. The monitor turns off automatically after 2 minutes of inactivity while displaying stored results. You can also press "START" to turn it off manually.

[Diagrams showing the LCD display when reviewing stored results.]

9. Deleting Measurements from the Memory

While a result is displayed, press and hold the "MEM" button for three seconds. All results will be deleted after three "beep" sounds. Press "MEM" or "START" to turn off the monitor.

[Diagrams showing the LCD display during the deletion process.]

Assessing High Blood Pressure for Adults

The following guidelines for assessing high blood pressure have been established by the World Health Organization (WHO). Other factors like diabetes, obesity, and smoking should also be considered. Consult your physician for accurate assessment and do not change treatment by yourself.

Classification of Blood Pressure for Adults

The table below shows WHO/ISH definitions and classification of blood pressure levels:

[Graph showing Systolic pressure on the Y-axis and Diastolic pressure on the X-axis, with shaded regions indicating different hypertension classifications: Normal BP, High-normal BP, Mild Hypertension, Moderate Hypertension, Severe Hypertension.]

Note: The color scheme is intended to discriminate between different levels of blood pressure and not as a basis for emergency diagnosis.

Troubleshooting

11. Troubleshooting (1)

12. Troubleshooting (2)

Maintenance

1. Do not drop the monitor or subject it to strong impact.
2. Avoid high temperature and solarization. Do not immerse the monitor in water.
3. If stored near freezing, allow it to acclimate to room temperature before use.
4. Do not attempt to disassemble the monitor.
5. If not using the monitor for a long time, remove the batteries.
6. Performance should be checked every 2 years or after repair. Contact the service center.
7. Clean the monitor with a dry, soft cloth or a soft cloth lightly moistened with water, diluted disinfectant alcohol, or diluted detergent.
8. No component can be maintained by the user. Technical information for repair is available to qualified personnel.
9. The monitor maintains safety and performance for a minimum of 10,000 measurements or three years. Cuff integrity is maintained after 1,000 open-close cycles.
10. It is recommended to disinfect the cuff 2 times weekly if needed (e.g., in a hospital). Wipe the inner side of the cuff with a soft cloth moistened with Ethyl alcohol (75-90%), then dry by airing.

Explanation of Symbols on Unit

• ?: THE OPERATION GUIDE MUST BE READ
• ⚠️: WARNING
• BF: TYPE BF APPLIED PARTS (The cuff is type BF applied part)
• ♻️: ENVIRONMENT PROTECTION - Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local Authority or retailer for recycling advice.
• [manufacturer]: MANUFACTURER
• CE0197: COMPLIES WITH MDD93/42/EEC REQUIREMENTS
• [date]: DATE OF MANUFACTURE
• [EU rep]: EUROPEAN REPRESENTATION
• [serial]: SERIAL NUMBER
• [keep dry]: KEEP DRY

Electromagnetic Compatibility Information

Table 1: For all ME EQUIPMENT and ME SYSTEMS - Electromagnetic Emissions

The KD-595 is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

Table 2: For all ME EQUIPMENT and ME SYSTEMS - Electromagnetic Immunity

The KD-595 is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

Table 3: For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING - Electromagnetic Immunity

The KD-595 is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

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 reflection from structures, objects and people.

a Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KD-595 is used exceeds the applicable RF compliance level above, the KD-595 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the KD-595.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 4: Recommended separation distances between portable and mobile RF communications equipment and the KD-595

The KD-595 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KD-595 as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d (in meters) can be determined 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 reflection from structures, objects and people.

Disposal

♻️ The product must not be disposed of with domestic waste. Users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. For information on recycling points, contact local authorities, recycling centers, or the place of purchase. Incorrect disposal may result in fines or penalties.

GIMA Warranty Conditions

Congratulations on purchasing a GIMA product. This product meets high qualitative standards. The warranty is valid for 12 months from the date of supply by GIMA. During this period, GIMA will repair or replace, free of charge, all defective parts due to production reasons. Labor costs, personnel travel expenses, and packaging are not included. Wearable components are not covered by the warranty.

Repair or replacement during the warranty period does not extend the warranty. The warranty is void in cases of: repairs by unauthorized personnel, use of non-original spare parts, defects caused by negligence or incorrect use. GIMA is not responsible for malfunctioning due to external factors such as voltage changes, electromagnetic fields, radio interference, or software issues.

The warranty is void if these regulations are not observed, or if the serial code has been removed, cancelled, or changed. Defective products must be returned only to the dealer from whom they were purchased. Products sent directly to GIMA will be rejected.