GIMA ARM-30E+ Digital Blood Pressure Monitor

Product Information

Model: ARM-30E+

Manual Version: A4A3

Publication Date: 2024-03

Table of Contents

1. Checks upon opening the package
2. Package contents
3. Safety precautions
4. Product composition
5. Intended use / Instructions for use
6. Contraindications
7. Product components
8. Preparation
9. Function settings
10. Procedure for correct measurement execution
11. Warnings and precautions
12. Frequently asked questions about blood pressure
13. Anomaly management
14. Cleaning and disinfection
15. Care and maintenance
16. Specifications
17. Appendix 1 EMC Information

1. Checks upon opening the package

Before use, carefully open the package and verify that all parts listed in the following table of package contents are present and have not been damaged during transport. Proceed with installation and use strictly following the manual.

2. Package contents

3. Safety precautions

The warnings and illustrations in this manual are intended to allow the user to operate the device safely and correctly, avoiding harm to themselves and others. The specific meaning of each symbol is as follows:

• Symbol: ⚠️ Meaning: Attention: Read and carefully follow the instructions (warnings) for use.
• Symbol: ? Meaning: Fragile, handle with care.
• Symbol: ☀️ Meaning: Store away from sunlight.
• Symbol: ? Meaning: Manufacturer.
• Symbol: ? Meaning: Date of manufacture.
• Symbol: IP21 Meaning: Degree of protection of the enclosure.
• Symbol: ? Meaning: Low voltage notification.
• Symbol: ℹ️ Meaning: Follow the instructions for use.
• Symbol: SN Meaning: Serial number.
• Symbol: BF Meaning: Type BF applied part.
• Symbol: ? Meaning: Lot number.
• Symbol: ?? Meaning: Authorized representative in the European Community.
• Symbol: ♻️ Meaning: WEEE disposal.
• Symbol: MD Meaning: Medical device.
• Symbol: ?? Meaning: Imported by.
• Symbol: CE0123 Meaning: Medical device compliant with Regulation (EU) 2017/745.
• Symbol: UDI Meaning: Unique device identifier.
• Symbol: REF Meaning: Product code.
• Symbol: ❄️ Meaning: Store in a cool, dry place.
• Symbol: % Meaning: Humidity limit.
• Symbol: ⬆️ Meaning: Atmospheric pressure limit.
• Symbol: ?️ Meaning: Temperature limit.
• Symbol: RoHS Meaning: RoHS Mark.

4. Product composition

This product consists of a main unit and a cuff.

5. Intended use / Instructions for use

The Sphygmomanometer is intended for use in a domestic environment or in healthcare facilities for measuring systolic and diastolic blood pressure and pulse rate in adults using a non-invasive oscillometric technique.

Intended users

1. Healthcare professional or lay user.
2. Who has read and understood the user manual.

Clinical benefits

The device allows patients to monitor their systolic blood pressure, diastolic blood pressure, and pulse rate at any time in their own home. This allows for a significant reduction in hospital visits, and the consequent risks associated with travel, improving patients' quality of life.

6. Contraindications

To avoid inaccurate measurements or injuries, do not use this device in the presence of any of the following contraindications:

1. This device is not suitable for patients with implanted electronic devices, such as pacemakers and defibrillators.
2. Avoid measuring on the same side of the arm as a mastectomy or lymph node dissection.
3. The device measures blood pressure using a pressurized cuff. Do not use the device if the limb chosen for measurement has lesions (e.g., open wounds), is affected by ongoing pathologies, or is used for administering therapy (e.g., phlebolysis); these conditions make it unsuitable for contact with or exposure to the pressure exerted by the cuff and may worsen the lesions or pathologies.
4. Avoid taking measurements on patients with disorders, diseases, and sensitivity to certain environmental conditions that may render them unable to control their movements (e.g., tremors or shivers) and on patients unable to communicate clearly (e.g., infants and unconscious patients).
5. To determine blood pressure, the device uses the oscillometric method. The arm subjected to measurement must have normal perfusion.

The device is not intended for use on limbs where blood circulation is limited or altered. If you suffer from perfusion or blood disorders, consult your doctor before using the device.

7. Product components

(1) Main unit

Display

User selection and date/time setting button

Power on/off button

Memory access button

Speaker (audio version only)

USB-C input for DC power

(2) Display screen

Date and time

User icon

Inflation icon

Deflation icon

Memory icon

Correct cuff placement indicator

Registration number

Movement detection indicator

Heartbeat icon

Blood pressure icon

Average blood pressure icon

Pulse rate value

Battery charge status indicator

Irregular heartbeat indicator

Pressure unit

8. Preparation

(1) Battery installation

1. Open the battery compartment cover as illustrated in the figure.
2. Insert 4 AAA batteries into the battery compartment, paying attention to the battery polarity indication. Refer to the image below for correct battery installation.

Warning: If you do not plan to use the device for a prolonged period (over 3 months), remove the batteries.

(3) USB-C power supply (cable not included in the package)

The product can be powered by connecting an external DC power adapter (5V, 1A) via the USB-C connector.

NOTE:

• The DC adapter power supply is indicated for a limited period when AAA batteries are not available. The adapter must comply with IEC 60601-1 standards and its specifications must meet the following requirements: input: AC 100~240 V 50/60 Hz, output: DC 5V 1.0 A. Other AC adapters may have different output voltages and polarities, which could pose a risk to life and damage the device.

9. Function settings

(1) User selection

When the device is in standby, press the "?" button to access the user group selection interface. Then press the "?" button again to switch to other user groups.

[Image showing user selection]

(2) Date and time setting

When the device is in standby, press the "?" button for approximately 3 seconds to access the date setting; the "year" will flash. Press the "▶️" button to set the desired year, then use the "?" button to confirm the selection. Once the "year" is set, the month setting will be accessed automatically. At this point, the "month" icon will flash. Use the "▶️" button to scroll to the desired setting. Proceed analogously to set "day", "hour", and "minute".

[Image showing date and time setting progression]

(3) Display unit setting

When the device is in standby, press and hold the "⚙️" button for about 5 seconds to access the unit setting. Press the "⚖️" button to switch from mmHg to kPa. Press the "✅" button to confirm the selected unit. The default unit is mmHg.

10. Procedure for correct measurement execution

(1) Preparation for measurement

• Remove any clothing covering the arm.
• Always take measurements on the same arm (generally the left arm). During measurement, remain still and quiet.
• Try to relax as much as possible and avoid talking while the measurement is IN PROGRESS.
• Take blood pressure measurements every day at the same time.
• Do not take measurements immediately after physical activity or bathing. Rest for about 20-30 minutes before repeating a measurement.
• The readings may be influenced by the following conditions: Consumption of food, wine, coffee, tea, physical activity within one hour before measurement; talking, being agitated, being in an unstable mood, bending forward, moving, sudden changes in ambient temperature during measurement; being inside a moving vehicle, taking repeated and consecutive measurements.

(2) Wearing the cuff correctly

1. Connect the cuff to the device by firmly inserting the air tube plug into the designated port.

[Image showing cuff connection]

Cuff

Air tube plug

Air tube

Port for air tube

2. Insert your hand inside the cuff. Pull the free end of the cuff until it reaches the upper left part of your arm.

[Image showing cuff application]

Note: The lower edge of the cuff should be about 2 - 3 cm (0.8-1.2 inches) above the inner elbow. The air tube should be positioned on the inside of the arm and aligned with the middle finger.

[Diagram showing cuff placement relative to the elbow]

Lower edge: 2 - 3 cm (0.8-1.2 inches)

Ensure that the air tube is positioned on the inner side of the arm and that the cuff is wrapped snugly so that it cannot move around the arm.

Note: Repeated measurements can cause blood congestion in the arm, which will affect the measurement results. Be careful not to rest your arm on the air tube.

To avoid potential blood congestion and ensure measurement accuracy, it is recommended to raise your left hand, open and close your fist several times, or remove the cuff and rest for at least 2-3 minutes before taking the measurement.

(3) Sitting correctly

Take the measurement when relaxed and comfortably seated in a comfortable environment with a comfortable temperature. Rest your arm on a flat surface, such as a table.

• Sit on a comfortable chair with your back and arms supported.
• Keep your feet flat on the floor and do not cross your legs.
• When the arm is resting comfortably on a table, the cuff should be level with the heart.

Warning: Be careful not to twist the connection tube, as the pressure exerted by the cuff could disturb blood flow and cause patient injury.

(4) Taking a measurement

1. Fasten the cuff following the instructions in point 2 and start the measurement only after correctly wearing the cuff.
2. Press the "▶️" button. All icons will be displayed, then the device will start inflating the cuff and "00" will be displayed on the screen.

[Image sequence showing measurement process]

Check the measured values at the end of the measurement.

Note: If you feel unwell during the measurement, press the "▶️" button immediately to stop the measurement.

When the correct inflation pressure is reached, the value displayed on the screen will gradually decrease, and the heartbeat symbol will flash. At the end of the measurement, the results of systolic blood pressure, diastolic blood pressure, and pulse will be displayed on the screen.

Note: In case of unexpected results, consult your doctor.

(5) Memory function

1. Each measured value is automatically stored in the appropriate user group. This device can store up to 99 sets of measurements for each user. When the memory is full, older values will be replaced by new ones.

When the device is in standby mode, press the "?" button once to view the average value of the last 2 or 3 blood pressure measurements. Pressing the "?" button again will display the last measured value.

Pressing the "?" button again will allow you to scroll through the other results in memory.

(6) Memory deletion

When the device is in standby mode, press the "?" button to select the user group for which you want to delete the measured values.

Press the "▶️" button to turn off the device, then press the "▶️" button once to activate the screen. Repeatedly press the "❌" button for 3 seconds to delete the results in the selected user's memory; finally, the "✅" icon will be displayed on the screen.

(7) Correct cuff placement indication

When the cuff is worn correctly, the "✅ (OK)" icon is always displayed on the screen. If the cuff is not tight enough, the "⚠️ o)" icon will flash to indicate this. If the "⚠️ o)" icon flashes, press the "▶️" button to stop the measurement.

(8) Movement detection indication

If the user moves their body or arms during measurement, incorrect results may be obtained. In this case, the "?" icon will flash, and it will be necessary to correct the posture and repeat the measurement.

(9) Device shutdown

To turn off the sphygmomanometer, simply press the "▶️" button. The device will automatically turn off after 1 minute.

11. Warnings and precautions

Warnings

• No maintenance or repair operations can be performed while the device is in use.
• Too frequent measurements can interfere with blood flow and cause subsequent injuries to the PATIENT.
• Before using the device on an arm with an intravascular access or for administering therapy or an arteriovenous shunt (A-V), consult a doctor, as temporary interference with blood flow could cause injury.
• If you have undergone a mastectomy or lymph node dissection, consult your doctor before using this device.
• Do not use ME monitoring EQUIPMENT simultaneously on the same limb. This could cause temporary loss of function or inaccurate measurements.
• Monitor the limb being measured to ensure that the operation of the Sphygmomanometer does not cause long-term impairment of the patient's blood circulation.
• Use components (e.g., cuff) supplied by the manufacturer. Otherwise, measurement accuracy may be compromised.
• Modifications to this device are not permitted.
• To avoid the risk of suffocation, keep the air tube and USB-C charging cable out of the reach of newborns, infants, and children.
• Keep small parts out of the reach of children as they may ingest them. If a child accidentally ingests small parts, such as the battery cover, contact a doctor immediately.
• The cuff complies with ISO 10993-5, ISO 10993-10, ISO 10993-23 requirements. However, some particularly sensitive individuals may experience allergic reactions.
• DO NOT use this device on an injured arm or an arm undergoing medical treatment.

Precautions

• Do not perform measurements more frequently than necessary. Possible interference with blood flow could cause hematomas.
• Maintenance should be performed by the manufacturer in accordance with the instructions.
• If the device has been stored in a place where the temperature was below 5°C, before use it must be left in a place where the ambient temperature is between 5°C and 40°C for at least 1 hour; if the device has been stored in a place where the temperature was above 40°C, before use it must be left in a place where the ambient temperature is between 5°C~40°C for at least 2 hours.
• DO NOT use this device on newborns, infants, children, or people who cannot express themselves.
• DO NOT take medication based on the device's results. Consult your doctor for specific information about your blood pressure. Patients should not make diagnoses or take medication based on measurement results. Follow the instructions of your doctor or healthcare provider.
• DO NOT use the device when a phlebolysis or blood transfusion is in progress.
• DO NOT use this device in areas with high-frequency surgical equipment (HF), magnetic resonance imaging (MRI) equipment, and computed tomography (CT) scanners. In such circumstances, the device may malfunction and/or produce inaccurate results.
• Ensure that the cuff is not placed on a limb where medical treatments, such as access devices or arteriovenous shunts (AV), are in progress.
• If you suffer from common cardiac arrhythmias, such as atrial or ventricular, premature beats or atrial fibrillation, atherosclerosis, poor perfusion, diabetes mellitus, preeclampsia, kidney disease, or are pregnant, consult your doctor before using this device.
• In case of skin irritation or discomfort, discontinue use of the device and consult your doctor.
• If you suffer from severe blood circulation problems or blood disorders, consult your doctor before using the device, as cuff inflation may cause hematomas.
• DO NOT use this device for purposes other than measuring blood pressure and pulse rate. DO NOT disassemble or attempt to repair the device or other components, as this may lead to inaccurate results.
• DO NOT use the device in humid places or where it may be exposed to water splashes, as this could damage the device.
• DO NOT use the device in moving vehicles, for example in cars.
• DO NOT drop the device or subject it to strong impacts or vibrations.
• DO NOT use or store the device outside the conditions specified by the manufacturer (particularly high or low temperatures and humidity), as this could affect performance or cause inaccurate measurements.
• If you notice a change in performance (e.g., inaccurate measurement or abnormal display), stop using it immediately and contact the assistance service personnel as soon as possible.

12. Frequently asked questions about blood pressure

Q1: Why can blood pressure readings taken at home be lower than those taken at the hospital?

• The difference in blood pressure between home measurement and hospital measurement is about 20 mmHg - 30 mmHg (2.7 kPa - 4.0 kPa). This is because people tend to be more relaxed at home than in the hospital.
• Furthermore, when the device is positioned above the heart, blood pressure values tend to be much lower than actual values. Therefore, it is important to ensure that the device is positioned at heart level.

Q2: Why can blood pressure readings taken at home be higher than those taken at the hospital?

• If the patient is using antihypertensive medication, it is possible that it has lost its effectiveness. Always follow your doctor's instructions.
• The cuff may not have been positioned correctly. If the cuff is not positioned correctly, no blood pressure reading will be obtained, while the blood pressure value may be much higher than the actual value. Therefore, pay attention to the correct positioning of the cuff.
• The cuff may not be tight enough. If the cuff is not tight enough, the compression force may not be transmitted to the artery and, consequently, the blood pressure value may be much higher than the actual value. In this case, it is necessary to readjust the cuff and tighten it properly.
• The patient is not sitting correctly during the measurement. During blood pressure measurement, it is not advisable to maintain a hunched, tilted, or cross-legged posture, as in these positions abdominal pressure increases or the arm is positioned below the heart. During measurements, it is necessary to maintain a correct posture.

Q3: What is the best time to take measurements?

• It is preferable to take measurements in the morning immediately after urination or when the body and mind are stable. It is recommended to take measurements at the same time of day.

Q4. Why is the blood pressure value different each time?

1. Blood pressure varies slightly with each contraction. For example, in a subject with a pulse of 70 beats per minute, blood pressure will vary 100,800 times a day. Since blood pressure changes continuously, it is difficult to obtain the correct value by measuring it only once. It is advisable to repeat the measurement 2-3 times. Normally, the first measurement result is higher due to agitation or inadequate preparation, as in the second measurement you are more relaxed, the measurement result is usually 5-10 mmHg (0.7-1.3 kPa) lower than the first. This difference is more evident in subjects with higher blood pressure.

--When taking consecutive measurements, keep in mind that: Due to cuff compression, blood extravasation may occur, resulting in poor blood flow to the fingertips. Subsequent measurements after blood extravasation will not produce correct results. Loosen the cuff, raise your hand above your head, grasp and extend your palms 5 times. This will help drain the extravasated blood, and you can proceed with blood pressure measurement.

13. Anomaly management

* If the measurement does not occur correctly, one of the following symbols will be displayed. Use the correct measurement method.

* Troubleshooting

If, after applying the solutions described above, it is still not possible to measure blood pressure, contact the retailer. DO NOT attempt to disassemble the device yourself.

14. Cleaning and disinfection

(1) Cleaning

The device can be cleaned with a soft, clean cloth dampened with a small amount of neutral detergent or water. It is recommended to clean the device before and after each use. Each cleaning should not last more than 3 minutes. Do not clean more than 3 times consecutively.

⚠️ Do not use corrosive detergents. During cleaning, be careful not to immerse any part of the device to prevent liquid from entering the instrument.

(2) Disinfection

Recommended disinfectant: 75% alcohol for medical use

Steps:

1. Thoroughly clean the device with a soft, clean cloth dampened with a small amount of the disinfectant indicated above and immediately dry with a soft, clean, and dry cloth.
2. The device body can also be cleaned and disinfected with a soft, clean cloth dampened with a small amount of 75% medical alcohol.

⚠️ Do not use steam disinfection, high temperature, or UV rays. These methods could damage the device and shorten its lifespan.

It is recommended to disinfect the device before and after use. Disinfection should not last more than 1 minute. Do not disinfect more than 2 times consecutively.

(3) Disposal

The disposal of the device, other components, and optional accessories must be carried out according to local regulations. Improper disposal can pollute the environment.

Notes:

• Do not bend or excessively fold the air tube.
• Do not store the device or its components:
• if they are wet.
• by storing them in places where temperature and humidity reach extreme levels; in a spot exposed to direct sunlight, or in the presence of dust and corrosive gases.
• by storing them in areas prone to vibrations or shocks.

15. Care and maintenance

[Image of cleaning supplies and device]

Water or neutral detergent

Keeping the device surface clean and tidy contributes to prolonging the life of the sphygmomanometer.

• If the main unit is dirty, clean it with a soft, dry cloth.
• If dirt cannot be easily removed, rub with a soft cloth dampened with water or neutral detergent, then dry with a dry cloth.
• It is recommended to calibrate the device at least once a year. If necessary, contact the manufacturer or agent.

Warning: Do not allow water or other liquids to penetrate the device. If this happens, the device and cuff will be damaged, and the sphygmomanometer will no longer be usable.

16. Specifications

The product has been clinically tested according to the requirements of the ISO 81060-2 standard.

Note: The specified power supply must meet the following conditions: Output voltage: 5V DC, Output current: 1000mA, Compliance with IEC 60601-1 standard, Class II. At least two MOPP isolations between the AC input and DC output. Compliance with US and Canadian deviation requirements.

Essential Functionality

1. Measurement Range (Blood Pressure): SYS: 57 - 255 mmHg, DIA: 25 - 195 mmHg Pulse Rate: 40 - 199 bpm
2. Cuff Pressure Accuracy: ±3 mmHg (±0.4 kPa)
3. Pulse Rate Accuracy: ±5%

17. Appendix 1 EMC Information

Manufacturer's guidelines and declaration - Electromagnetic Emissions

The Sphygmomanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Sphygmomanometer must ensure that it is used in such an environment.

Manufacturer's guidelines and declaration - Electromagnetic Immunity

The Sphygmomanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Sphygmomanometer must ensure that it is used in such an environment.

NOTE: UT is equivalent to the AC mains voltage before the test level is applied.

Manufacturer's guidelines and declaration - Electromagnetic Immunity

The Sphygmomanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Sphygmomanometer must ensure that it is used in such an environment.

Manufacturer's guidelines and declaration - Electromagnetic Immunity

Warning:

• The use of this product in proximity to other equipment or superimposed on it should be avoided, as it may cause improper operation. In cases where it is necessary to use the product in this configuration, the device itself and other equipment must be monitored to verify that they are functioning normally.
• The use of accessories, transducers, and cables other than those supplied or specified by the device manufacturer may cause an increase in electromagnetic emissions or a decrease in the device's electromagnetic immunity, causing it to malfunction.
• Do not use near HF surgical equipment and RF shielded rooms of an ME system for magnetic resonance imaging where EM interference intensity is high.
• Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should be used at a distance of at least 30 cm (12 inches) from any part of the equipment, including manufacturer-specified cables. Otherwise, the equipment's performance may be compromised.

Note: Any serious incident that occurs in relation to the use of the device must be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient are located.

GIMA WARRANTY CONDITIONS

The standard Gima B2B warranty of 12 months applies.

Disposal: The product must not be disposed of with other household waste. Users must ensure the disposal of obsolete equipment by taking it to the designated collection point for the recycling of electrical and electronic equipment.