Etekcity TMB-1583-BS Smart Blood Pressure Monitor User Manual

Etekcity TMB-1583-BS Smart Blood Pressure Monitor User Manual

Package Contents

1. 1 x Smart Blood Pressure Monitor
2. 1 x AC Adapter
3. 1 x Arm Cuff
4. 4 x 1.5V AAA Batteries
5. 1 x User Manual
6. 1 x Quick Start Guide

Specifications

• Power Supply 4 x 1.5V AAA batteries
• DC Output: 6V, 1A
• AC Adapter
• Model: TRANSTEK
• BLJ06L060100P-U
• Input: AC 100–240V 50/60Hz 0.2A Max
• Output: DC 6V, 1A
  Note: Please use the AC adapter authorized by the manufacturer.
• Display Mode Digital LCD, V. A. 3.3 x 2.9 in / 8.4 x 7.3 cm
• Measurement
• Mode
• Oscillographic
• Testing Mode
• Measurement
• Range
• Rated Cuff Pressure:
• 0–299 mmHg / 0–39.9 kPa
• Measurement Pressure:
• SYS: 60–230 mmHg / 8.0–30.7 kPa
• DIA: 40–130 mmHg / 5.3–17.3 kPa
• Pulse: 40–199 beats/minute
• Accuracy
• Pressure: 5°–40°C within ±3 mmHg / 0.4 kPa
• Pulse: ±5%
• Units mmHg / kPa
• Operating
• Environment
• Temperature: 41°–104°F / 5°–40°C
• Relative Humidity: 15–90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa
• Atmospheric Pressure Range: 700–1060 hPa
• Transport and Storage Environment
• Temperature: -4°–140°F / -20°–60°C
• Relative Humidity: ≤ 93% noncondensing, at a water vapour pressure up to 50 hPa
• Dimensions
• Monitor: 4.2 x 4.1 x 4.6 in / 10.7 x 10.3 x 11.8 cm
• Cuff Circumference: 8.6–16.5 in / 22–42 cm
• Weight 0.55 lb / 0.25 kg (excluding batteries and cuff)
• Mode of Operation Continuous Operation
• Degree of Protection (Arm Cuff)
• Type BF Applied Part Water Protection Level
• IP21 (It means the device could be protected against solid foreign objects of 12.5mm Ф and greater, and against vertically falling water drops.)
• Device
• Classification
• Battery Powered Mode: Internally
• Powered ME Equipment
• AC Adapter Powered Mode:
• Class II ME Equipment
• Software Version A01
• Automatic Shutoff 120 seconds
  Note: Can be customized in the VeSync app

Features

• Blood pressure measurement
• Pulse rate measurement
• Result storage
• 90 records per user (unlimited records in the VeSync app)
• Measurement during inflation
• Readings taken by this monitor are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method
• Smart Bluetooth® connection
• Access to smart functions through the free VeSync app

Safety Information

Please read and follow all instructions and safety guidelines in this manual.

CAUTION

• This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument such as a pacemaker or defibrillator.
• This device is not intended to be a diagnostic device. Contract your physician if hypertensive values are indicated.

Indications for Use: 

• This Blood Pressure Monitor TMB-1583-BS is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 42 cm. The device can be used to detect irregular heartbeat.
• It is intended for adult, home use.
• If the arm cuff causes any discomfort, immediately press to turn off the monitor.
• This monitor is intended for adult use in homes only. Do not use the monitor on babies or younger children. Consult your doctor before using this monitor on older children.
• This monitor is not suitable for use on neonatal patients, pregnant women, patients with implanted electronic devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, or peripheral arterial disease, patients undergoing intravascular therapy or arterio-venous shunt, or patients who received a mastectomy. Please consult your doctor prior to using the monitor if you suffer from any illnesses.
• This monitor is not intended for patient transport outside a healthcare facility.
• This monitor is not intended for public use. Household use only.
• This monitor is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
• The monitor is not intended to be a diagnostic device. The results are for reference only and cannot substitute for a doctor’s diagnosis. Only a healthcare professional is qualified to interpret blood pressure measurements.
• If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician. Do not begin or end medical treatment without asking a physician for treatment advice.
• Do not take any therapeutic measures on the basis of a self-measurement. Consult your physician if you have any questions about your blood pressure.
• When this monitor is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best results may still be inaccurate. Please consult your physician about the results.
• Do not kink the connection tube during use. This may cause the cuff pressure to continuously increase, which can prevent blood flow and result in harmful injury to the patient.
• When using this monitor, the following situations may interrupt blood flow and influence blood circulation, resulting in harmful injury to the patient:
• Measuring with a kinked connection tube too frequently or for multiple consecutive measurements
• Using the cuff on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present
• Inflating the cuff on the side of a mastectomy
• WARNING: Do not apply the cuff over a wound, as it can cause further injury.
• If a limb has other monitoring ME equipment applied to it, do not inflate the cuff on that limb. This could cause the other monitoring ME equipment to temporarily lose function.
• Rarely, a fault may cause the cuff to remain fully inflated during measurement. In this case, open the cuff immediately. Prolonged high pressure (cuff pressure > 300 mmHg or constant pressure > 15 mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis (bruising).
• Always check to make sure that operating this monitor does not result in prolonged impairment of patient blood circulation.
• When measuring, please avoid compression or restriction of the connection tubing.
• The monitor cannot be used with HF surgical equipment.
• To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
• Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
• This monitor is not suitable for continuous monitoring of blood pressure during medical emergencies or operations. The patient’s arm and fingers will become anaesthetic, swollen, and even purple due to a lack of blood.
• When not in use, store the monitor with the adapter in a dry room and protect it against extreme moisture, heat, lint, dust, and direct sunlight. Never place any heavy objects on the storage case.
• This monitor may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
• This monitor contains sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
• This monitor is not AP/APG equipment and is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• WARNING: No servicing/maintenance while the ME equipment is in use.
• The patient is an intended operator of this monitor. The patient can measure, transmit data, and change batteries under normal circumstances and maintain the monitor and its accessories according to the user manual.
• To avoid measurement errors, please avoid using in the presence of a strong electromagnetic field radiated interference signal or an electrical fast transient/burst signal.
• The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don’t use this monitor or cuff.
• During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5 and ISO 10993-10. It will not cause any potential sensitization or irritation reaction.
• The included adapter is specified as ME EQUIPMENT.
• If you experience discomfort during a measurement, such as pain in the arm or other complaints, press to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
• If the cuff pressure reaches 40 kPa / 300 mmHg, the cuff will automatically deflate. Should the cuff not deflate when pressure reaches 40 kPa / 300 mmHg, detach the cuff from the arm and press to stop inflation.
• Before use, make sure the monitor and accessories function safely and are in proper working condition. Do not use the monitor or accessories if they are damaged in any way. The continuous use of a damaged monitor or damaged accessories may cause injury, improper results, or serious danger.
• Do not wash the cuff in a washing machine or dishwasher.
• The service life of the cuff may vary based on the frequency of washing, skin condition, and storage state. The typical service life is 10,000 times used.
• We recommend that the performance of the monitor and cuff should be checked every 2 years and after maintenance and repair,
• Be careful to avoid strangulation due 12 to cables and hoses, particularly due to excessive length.
• At least 30 min are required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 min are required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.
• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect this monitor and should be kept at least a distance “d” away from theequipment. Distance “d” is calculated by  MANUFACTURER from the 80MHz to 5.8GHz column of Table 4 and Table 9 of IEC 60601-1-2, as appropriate.
• Only use ACCESSORIES and detachable parts specified/authorized by the MANUFACTURER. Using other parts or accessories may cause damage to the monitor or danger to the users/patients.
• There are no luer lock connectors used in the construction of tubing. If there were, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
• Please use the monitor in the environment which is provided in the user manual. Otherwise, the performance and lifetime of the monitor will be impacted and reduced.
• This monitor is not intended for public use. Household use only.

Glossary of Symbols

These symbols might be in the user manual, labelling, or other components.

It means the device could be protected against solid foreign objects of 12,5mm Ф and greater, and against vertically falling water drops.

Caution

Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.

MR Unsafe

This device is not intended to operate in Magnetic Resonance environment. Do not take the device into MR environments.

Getting to Know Your Blood Pressure Monitor

• The Etekcity Smart Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with an arm circumference of 8.6–16.5 inch / 22–42 cm.
• Blood pressure monitors use the oscillometric method of measuring blood pressure. Before every measurement, the monitor establishes a “zero pressure” equivalent to the atmospheric pressure.
• It then starts inflating the arm cuff while detecting pressure oscillations generated by beat-to-beat pulsations, which is used to determine the patient’s systolic and diastolic blood pressure and pulse rate.

Function Diagram

1. A. Display
2. B. Cuff
3. C. Adapter
4. D. Air Plug
5. E. Air Hose
6. F. Set Button
7. G. Lock Button
8. H. Start/Stop Button
9. I. Memory Button
10. J. Battery Compartment
11. K. DC Power Socket
12. L. Air Connector Plug

LCD Display

1. A. User 1 / User 2
2. B. Memory
3. C. Average Value (Last 3 Records)
4. D. Current Time
5. E. Bluetooth Icon
6. F. Bluetooth Connection
7. G. Low Battery
8. H. Systolic Blood Pressure (High Blood Pressure)
9. I. mmHg Measurement Unit
10. J. kPa Measurement Unit
11. K. Diastolic Blood Pressure (Low Blood Pressure)
12. L. Pulse (Beats Per Minute)
13. M. Irregular Heartbeat
14. N. Motion Indicator
15. O. Blood Pressure Level

Power Supply Information

Batteries: 4 x 1.5V DC AAA Batteries
AC Adapter: 6V DC 1A

• Please use the AC adapter authorized by the manufacturer.
• Unplug your adapter to use battery power.

Caution: For best results and to protect your monitor, use the correct batteries and correct power adapter which complies with local safety standards.

Installing and Replacing the Batteries

Note: Turn the monitor off before replacing the batteries.

• Open the battery compartment cover.
• Install the batteries by matching the correct polarity [Figure 1]

Replace the batteries when:

• + appears on the display.
• The display is dim.
• The display does not light up.

Caution:

• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose of the batteries in fire. Batteries may explode or leak.
• Remove batteries if the monitor is not likely to be used for some time.
• Worn batteries are harmful to the environment.
• Do not dispose with daily garbage. Dispose of the old batteries following your local recycling guidelines.

Before First Use

Setting Date, Time, and Measurement Unit

• Set the clock before using your blood pressure monitor so that your blood pressure records will have correct time stamps. The clock will automatically be set to the correct time when you pair the monitor with the VeSync App. Year Setting Range: 2020–2060 Time Format: 24 Hours
• When the monitor is off, press and hold the button to change settings.
• Press the button to change the year.

• When you have selected the right year, press to confirm and continue to setting the month and day.
• Repeat steps 2 and 3 to set the month and day.

• Repeat steps 2 and 3 to set the hour and minute. 6. Repeat steps 2 and 3 to set the measurement unit.

• Repeat steps 2 and 3 to choose whether the monitor will beep.
• After the beep is set, the display will show , then show all the settings you have selected, and then turn off.

REFRENCE LINK