1. The Basics This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observing this manual is a prerequisite for proper product performance and correct operations, which ensures patient and operator safety. 1.1 Safety Warnings and Tips Before using the device, please ensure that you have...
Page 4
Do not place this device in pressure vessels or gas ⚫ sterilization devices. This device is not intended for use by people (including ⚫ children) with restricted physical, sensory, or mental acumen or a lack of experience and/or a lack of knowledge unless they are supervised by someone responsible for their safety, or they receive instructions from this person on how to use the device.
Page 5
consult your doctor immediately if you experience symptoms that could indicate a serious disease. Do not self-diagnose or self-medicate based on this ⚫ device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
Page 6
To measure blood pressure, the arm must be squeezed ⚫ by the cuff hard enough to temporarily stop blood flow through the artery. This may cause pain, numbness, or a temporary red mark on the arm. This condition will appear especially when measurements are repeatedly taken.
operation of the device. The device shall only be maintained by qualified ⚫ professionals. The manufacturer shall provide the service personnel ⚫ with circuit diagrams, component part lists, descriptions, calibration instructions, or other information. 2. Introduction 2.1 Intended Use The Blood pressure monitor is intended to record, store, display and transfer single-channel electrocardiogram (ECG), blood pressure and pulse rate in adult population.
Product Features Model BP2B BP2V BP2W Software NIBP and NIBP and NIBP and NIBP and function Wireless Bluetooth Bluetooth Bluetooth Bluetooth mode and wifi and wifi Enclosure Dark White White Black colour green 2.2 Contraindications This device is contraindicated for use in ambulatory ⚫...
2. Function button Press to start the ECG measurement. ⚫ Press and hold for 2 seconds to review historical data. ⚫ 3. Display screen 4. LED indicator Blue light is on: the battery is charging. ⚫ Blue light is off: the battery is fully charged. ⚫...
Page 10
MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials. IP22 Resistant to liquid ingress Medical device CE marking Authorized representative in the European community UKCA marking Authorized Representative in the United Kingdom This product complies with the rules and regulations of the Federal Communication Commission.
Page 11
Find where to drop them off on the www.quefairedemesdechets.fr site (Only applicable for French market). Heartbeat symbol Battery symbol Bluetooth symbol Data transmission symbol ECG waveform ECG measurement progress bar Press to display next record Press to return to home screen Current record / Total records Low signal amplitude or noise Lead off when ECG is measuring...
3. Using the Monitor 3.1 Charging the Battery Use the USB cable to charge the monitor. Connect the USB cable to a USB charger or to the PC. It takes 2 hours to fully charge. When the battery is fully charged, the indicator will be off.
Page 13
Place the cuff directly against the skin, as clothing may cause a faint pulse and result in measurement errors. Constriction of the upper arm, caused by rolling up a shirtsleeve, may prevent accurate readings. Confirm that the artery position mark is lined up with the artery.
takes about 30s. 4. The readings will be displayed when the measurement is finished. You can press Start/Stop button again to stop the blood pressure measurement. Note: While taking measurements, you should remain still and not squeeze the cuff 3.2.5 After Taking Measurements The monitor will automatically release the gas in the cuff once finished taking measurements.
Page 15
While taking measurements, do not touch your body ⚫ with the hand with which you are taking measurements. Please note that there must be no skin to skin contact ⚫ between your right and left hand. Otherwise, the measurements cannot be taken correctly. Stay still while taking measurements, do not speak and ⚫...
To start an ECG Recording: 1.Put your right palm on the right side electrodes of the monitor. 2.Place the left side electrodes to the body position that you desired to measure. 3.Once the body parts are placed on the electrodes, press the Function button to start EKG recording.
For ECG recordings, the Heart Rate will be displayed first and then replayed over the 30-second ECG waveform. To view the next records, press the NEXT button. To exit the History screen, press the HOME button. 4.Troubleshooting Problem Possible Cause Solution No power.
Remove any measuring blood pressure on a clothing pressure. bare arm. interfering with the cuff. Error x (x>4) Contact Contact The device has customer customer malfunctioned. service. service. The ECG cable is off, or Check the ECG the body parts are not cable, or place Check the placed on the...
5.2 Cleaning Do not use any abrasive or volatile cleaners. ⚫ Use a soft dry cloth or a soft cloth moistened with mild ⚫ (neutral) detergent to clean your monitor and the arm cuff and then wipe them with a dry cloth. When electrodes are dirty, use a soft cloth or cotton ⚫...
6. Specifications Classifications EU Regulation MDR, EU 2017/745 EC Directive RED, 2014/53/EU Degree of protection against electrical Type BF shock Environmental Item Operating Storage Temperature 5 to 45°C -25 to 70°C Relative humidity 10% to 95% 10% to 95% (non-condensing) 700 to 1060 700 to 1060 Barometric...
Page 21
Rechargeable lithium-polymer Battery type battery Battery run time 500 measurements Charge time 2 hours Blood Pressure Measurements Technology Oscillometric Method Pressure 0 – 300mmHg measurement range Pressure ±3mmHg or 2%, measurement whichever is greater accuracy Pulse rate range 40 to 200 /bpm Pulse rate accuracy ±2 /bpm Clinical accuracy...
Frequency range 2.402 – 2.480 GHz Max RF power -10 dBm WI-FI Frequency range 2412-2484 MHz Durable period Useful life 5 years Note: The useful life here is calculated from the first use, n ot including storage time, not the shelf life! 7.
with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving antenna.
user's authority to operate the equipment. 9. Electromagnetic Compatibility The device meets the requirements of EN 60601-1-2. Warnings and Tips Using accessories other than those specified in this ⚫ manual may result in increased electromagnetic emissions or decreased electromagnetic immunity for the device.
Page 25
tests guidance The Blood Pressure Monitor uses RF energy only for its internal function. RF emissions Therefore, its RF emissions are very Group 1 CISPR 11 low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 The Blood Pressure Monitor is...
Page 26
should be at least 30%. ± 2kV for power Electrical supply lines fast 100kHz repetition transient/ frequency burst ± 1kV for input/output 61000-4-4 lines Surge ± 0.5kV, ±1kV differential 61000-4-5 mode line-line 0% U (100% dip in U for 0.5 cycle at 0°, 45°, 90°, 135°,180°, 225°, Voltage...
Page 27
(50/60 HZ) 50/60Hz should be at magnetic levels field IEC characteristic of a 61000-4-8 typical location in a typical commercial or hospital environment. Note: U is the AC mains voltage prior to application of the test level. Guidance and Declaration - Electromagnetic Immunity The Blood Pressure Monitor is intended for use in the specified electromagnetic environment.
Page 28
80MHz to 800MHz 800MHz to 2.7GHz Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Page 29
13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Page 30
electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment.
Need help?
Do you have a question about the Viatom BP2 and is the answer not in the manual?
Questions and answers
come collegare al telefono IOS