305078 - Sphygmomanometer Medicinalis - Free user manual and instructions

Product Type	Blood pressure monitor
Model	305078
Brand	Medicinalis
Measurement Method	Oscillometric
Display	LCD digital display
Memory	2 x 90 readings (2 users)
Power Supply	4 x AA batteries (1.5V) or AC adapter (optional)
Battery Life	Approximately 300 measurements
Dimensions	150 x 100 x 50 mm
Weight	300 g (without batteries)
Cuff Size	Standard 22-32 cm, optional large 32-42 cm
Clinical Validation	Yes (CE, FDA approved)
Irregular Heartbeat Detection	Yes
Arrhythmia Detection	Yes
Average of Last 3 Readings	Yes
Date and Time Display	Yes
WHO Blood Pressure Classification Indicator	Yes (color-coded)
Auto Shut-Off	Yes (after 1 minute of inactivity)
Cleaning and Maintenance	Wipe with a soft dry cloth; do not immerse in water
Safety Features	Auto-cuff deflation, error detection, low battery indicator

Frequently Asked Questions - 305078 Medicinalis

How do I set the date and time on the Medicinalis 305078?

Press and hold the SET button for 3 seconds. Then use the MEM button to adjust year, month, day, hour, and minute. Press SET to confirm each entry.

What should I do if the cuff does not inflate properly?

Ensure the cuff is securely wrapped around your upper arm and the air plug is fully inserted into the monitor. Check that the batteries are fresh or the AC adapter is connected. If the problem persists, contact customer support.

How can I switch between users?

Press the USER button to toggle between User 1 and User 2. Each user has their own memory storage for 90 readings.

What does the irregular heartbeat symbol mean?

If an irregular heartbeat is detected during measurement, a symbol (usually a heart with an arrow) will appear on the display. This indicates that the reading may not be accurate; it is recommended to repeat the measurement after resting.

How do I clean the blood pressure monitor?

Use a soft, dry cloth to wipe the monitor and cuff. Do not use any abrasive cleaners or immerse the device in water. Avoid getting the cuff wet.

What is the correct way to position the cuff?

Wrap the cuff around your bare upper arm, about 2-3 cm above the elbow. The air tube should be centered over your brachial artery. The cuff should be snug but not tight.

Why does the monitor show an error code?

Common error codes include E1 (cuff pressure too low), E2 (movement during measurement), or E3 (air leak). Refer to the manual for specific codes. Most errors can be resolved by repeating the measurement correctly.

Can I use the monitor while charging?

If using an AC adapter, you can operate the monitor while plugged in. However, battery-powered operation is also possible without the adapter.

How often should I replace the batteries?

Replace all four AA batteries when the low battery indicator appears. Using alkaline batteries is recommended for longer life.

Is the Medicinalis 305078 suitable for pregnant women?

This monitor is not specifically validated for use during pregnancy. Consult your healthcare provider for appropriate monitoring options.

USER MANUAL 305078 Medicinalis

Do not use this equipment in the MRI scan room

Table of contents

1. Deutsch 9
2. English 30

ENG: Latest information, drivers, user manuals and data sheets can be found at www.ganzeinfach.de in our download area.

Authorized representative: WellKang ltd

Address: The Black Church, St. Mary's Place, Dublin 7, D07 P4AX, Ireland

Important safety instructions

• Read the user manual carefully. Use this device only if you have completely read and understood the user manual.
• Do not use the device near flammable or explosive gas mixes.
• This product is intended for personal use only!
• The device is not suitable for constant monitoring of blood pressure.
• Keep your body, hands and fingers calm during the measurement.
• The device is just a tool for evaluating a patient's condition. A full evaluation of the health condition is only possible if further clinical and professional tests are carried out by a doctor.

• The device is neither suitable for cleaning with liquids nor for sterilisation.

• It should not be operated directly next to or in combination with other devices.

• The product should not be used with additional parts or attachments, accessories, or other devices which are not described in this manual.
• Never repair the device by yourself in case of malfunction or device error. Stop using the device and contact our customer service.
• The materials used that come in contact with the skin have been tested for compatibility. If you still notice skin irritation or something similar, stop using the device and contact your doctor.

• The device should not be opened nor repaired, as the proper functioning cannot be guaranteed otherwise. Non-compliance will result in lapse of warranty.

• Swallowing small parts such as packaging material, battery, battery cover, etc. can lead to suffocation.

• Do not allow children or infants to play with the device!
• Protect it from dust, vibration, moisture and extreme heat.
• The patient has to follow the instructions of the doctor and should not carry out the treatment.
  Self-assessment and self-treatment using the measured result, self-diagnosis of measured results and self-treatment are dangerous.
• The device should neither be used to evaluate diseases nor for first aid and continuous use.

• This product can not be used for transporting patients and for surgical treatments.

• Please press the "ON / OFF" button to end the process, if your arm feels uncomfortable or if the air continues to inflate without stopping.

• Children under the age of 12 should not use the device. If it is used by people aged between 12 and 18, it should be done under the supervision of an adult. Failure to follow the instructions may lead to accidents or problems.
• Use the device only for measuring the blood pressure.
• Do not use mobile phones near the device. Do not use it near magnetic fields.
• Do not use the device during movement.

• Do not use the device outdoors or in shower rooms!

• Ensure that the connecting hose is not kinked.

• Do not measure more than two times in a row. Take a break of at least 5 minutes between any two measurements. Otherwise, this can lead to blood extravasation
• Do not measure your blood pressure more than 6 times in a day.
• Do not place the cuff over a wound, since it can result in further injury.
• Do not measure not on the arm, which is on the side of a mastectomy. This could result in injuries.

• Monitor the air pressure value on the LCD display. During measurement, this should not exceed 280 mmHg, otherwise you should switch off the device by pressing the "ON / OFF" button.

• Do not bend the arm cuff or the air hose using force.

• The main unit should not be bumped or dropped.
• Do not carry out any service and maintenance during operation!
• Switch off the device immediately if it comes into contact with water.
• Use the product only on the upper arm.
• Do not use the device with / or near an MRI, CT or MRI equipment.

MR Unsafe

Do not use this equipment in the MRI scan room

Thank you for choosing a MEDICINALIS product. Please read the following user manual carefully so as to get the most from the product you have purchased.

1. Scope of delivery

• Upper arm blood pressure monitor
- Upper arm cuff
- microUSB charging cable
- User manual

2. Technical data

Power supply 5V DC via charging cable (130 mAh battery)
Charging time every 2 hours
Measurement method	Oscillometric measurement
Frequency range	2402 - 2480 Mhz
Max. transmission power 4 dBm
Measurement range	Blood pressure: 0-300 mmHgPulse 40-200 Beats/min
Accuracy	Static pressure: ±3 mmHgPulse ± 2 %
Operating conditions	+5°C~+ 40°C. 10 % RH - 95 % RHAmospheric pressure: 700 hPa-1060 hPa
Storage conditions	-25°C~+70°C. 10% RH - 95% RHAmospheric pressure: 700 hPa-1060 hPa
Classification	Type BF
Water / dust-resistance IP-22
Circumference of upper arm approx 22-42 cm
Features	Automatic shut off after 1 min of inactivityApp controlLarge memory capacityCardiac arrhythmia detection

The technical data may be changed without notice in case of any improvements.

3. Introduction

The device uses the oscillometric method for measuring blood pressure.

The automatic electronic blood pressure monitor is intended for use by medical professionals or at home for monitoring and display of diastolic, systolic blood pressure and pulse rate in adults. This is done by placing an arm cuff around the left upper arm.

The estimated service life of the product is 5 years.

The product meets the requirements of the electromagnetic compatibility of EN60601-1-2 and safety standards of EN60601-1-1 and performance of IEC 80601-2-30 as defined in the EEC Directive 93/42 / EEC.

4. About blood pressure

4.1. What is blood pressure?

Blood pressure is the pressure of blood in a blood vessel. Systolic pressure is generated when the heart contracts. Diastolic pressure is generated when the heart expands.

A high blood pressure has an adverse effect on your health and life expectancy.

Blood pressure is measured in millimetres of mercury (mmHg).

4.2. What is high blood pressure and how is it controlled?

An unusually high arterial blood pressure, if left uncontrolled, can cause many health problems including stroke and heart attack.

High blood pressure can be controlled by changing the lifestyle, avoiding stress, and using medication under medical supervision.

To prevent high blood pressure or keep it under control, we recommend the following:

• Do not smoke
  • Exercise regularly
• Reduce intake of salt and fats
  • Undergo regular physical checkups
• Maintain correct weight (ideal weight)

4.3. Why should you measure the blood pressure at home?

The blood pressure measured in a hospital or doctor's clinic can cause anxiety and result in readings which are 25 to 30 mmHg higher than those measured at home. Measurement at home reduces the effect of external influences on the blood.

The values measured by the doctor and, in addition, those measured at home, provide more safety and a more accurate and complete blood pressure history.

4.4. WHO (World Health Organization) -Blood pressure classification

Standards for assessing high blood pressure, without considering the age, have been established by the World Health Organization (WHO), and are shown in the following diagram.

4.5. Blood pressure variations

The blood pressure of a person varies a lot daily and seasonally.

It may vary by as much as 30 to 50mmHg during the day due to various conditions. The variations are even more pronounced in hypertensive individuals.

Normally the blood pressure increases when working or playing and drops to the lowest level during sleep. Hence do not let yourself be overly influenced by the results of a single measurement.

Take the readings every day at the same time following the procedure described in this manual and know your normal blood pressure.

Many measurements provide a more complete picture of the history of blood pressure.

Make sure that you always note the date and time when measuring your blood pressure. Consult your doctor to interpret your blood pressure data.

5. Precautions before each use

1. If you are taking medication, consult your doctor to determine the best time to measure your blood pressure. Never change a prescribed medication without first consulting your doctor.
2. For individuals having irregular or unstable peripheral circulation problems cause by diabetes, liver disease, hardening of the arteries, etc., the blood pressure may vary at the upper arm and the wrist.

3. The measurements can be affected if the device is used near televisions, microwave ovens, X-ray machines, mobile phones or other devices that emit strong electrical fields. To avoid such interferences, use the blood pressure monitor at an adequate distance from such devices or switch off those devices.

4. You should wash your hands before using the device.

5. Do not measure on the arm that is using ME devices at the same time for monitoring, as this may lead to loss of function.
6. Consult your doctor if the readings are unexpected.
7. The readings when measuring at home is probably lower than in the hospital because the mood is usually more relaxed.
8. Cuff pressure range 0 - 299 mmHg

6. Charging the batteries

Charge the monitor by connecting the USB cable to a USB charger or the USB port of the PC. The battery requires about 2 hours to charge completely.

During the charging process, the red LED glows. Once the device is charged fully, it switches off automatically.

The red indicator flashes if the battery is weak.

You can check the battery level in the app.

Note: The device cannot be used when charging.

7. Status LEDs

8. Initial use and operation

LED Meaning
Blue light flashing Switched	on, Bluetooth is not connected
Blue light on	Bluetooth is connected
Red red flashing Battery is low
Red light on Charging in process
Blue and red light flashing	Blood pressure is too high (over 300mmHg)

8.1 Installing the app

Search for the "AirBP" app in the Appstore of your smartphone and install it.

Connecting

1. Switch on the Bluetooth on your phone.
2. Press the button on the blood pressure monitor to switch it on. The blue indicator flashes and shows that the Bluetooth connection is ready.
3. Run the "AirBP" app on your Smartphone. The app will scan and locate the device. Select your device "AirBP" in the app.

Note: Keep the distance between the blood pressure monitor and phone within a maximum of 1.5 meters. Do not carry out Pairing in your phone settings.

The app can be downloaded from the Google Playstore or the Apple Appstore under the name "AirBP" and requires a smart phone or tablet.

8.3 Placing the cuff on the upper arm

1. Make sure that the upper arm cuff fits your upper arm circumference.

1. Wrap the upper arm cuff as shown around the upper arm, about 2-3 cm above the elbow. Place the cuff directly on the skin, as clothing may cause weak pulse and result in measurement errors.

2. Constricting the upper arm, caused by rolling up a sleeve, can also lead to measurement errors.

3. Wrap the upper-arm cuff so that it is comfortable and not too tight. Place the arm on the table (palm facing upward) so the cuff is at the same level as the heart. Ensure that the hose is not kinked.

9. Carrying out the measurement

9.1 Carrying out the measurements correctly

The following figure shows the optimal positioning of the cuff:

To make the surroundings optimum for the measurement, consider the following points:

1. Sit comfortably.
2. Make sure that your legs are not crossed.
3. Keep your feet flat on the floor.
4. Your back and arms should always be supported.
5. The centre of the cuff should always be at the same level as your heart. Relax as much as possible and do not talk during the measurement.

Measure your blood pressure every day at about the same time.

Do not measure immediately after physical exertion or a bath. Take a break of 20 to 30 minutes before carrying out the measurement.

The readings can be affected under the following conditions:

Within an hour after dinner, after drinking wine, coffee or tea, for example red tea. Or after sport activity and after bathing.

Talking, nervousness, restless mood, bending forward, moving around, and changes in the room temperature during measurement, can also change the readings.

9.2 Measuring the blood pressure

Navigate to the "MEASURE" button using the bottom bar in the app and click the "START" button on the screen of the app to start the measurement and follow the instructions for inflating the cuff by squeezing the pump with a speed controlled by the app.

Stop pumping once you are instructed to do so, keep the pump without pressing and wait for the next instruction. In some cases, if the app determines that the pressure in the cuff is not high enough for the measurement, then a "pump again" instruction is displayed.

Note: You should remain calm during the measurement. Otherwise, the blood pressure readings may be inaccurate. Stop pumping once the indicator flashes in blue and red (pressure is too high).

After the measurement

The blood pressure readings are displayed on the app interface once the measurement is completed. You have to press the release valve manually to deflate the cuff. If you forget to deflate the cuff manually after the measurement, the device releases the air slowly from the cuff automatically.

You can change the user name or add the ID (helps in managing data of multiple users), add a note, share or delete the results on the results page.

If the monitor detects an irregular heartbeat, the corresponding icon is displayed below the PR value.

Note: The device automatically switches off after two minutes if no action is taken.

10. Memory function (memory)

The device automatically stores the last measured readings. You can retrieve the values by pressing the "History" button.

11. Cleaning, care and maintenance

Follow the instructions given below to keep the blood pressure monitor in proper condition and to protect it from damage:

• Store the device always in the packaging when it is not being used.
• Do not fold the upper arm cuff too tightly. The lock may come into contact with the inside of the arm cuff and damage it.
• Clean the monitor and cuff with a soft, dry cloth.
• Do not use any abrasive or aggressive cleaning agents.

Caution!

• Never immerse the device or the components in water.
• Do not expose the monitor to very high or low temperatures. Keep it away from moisture or direct sunlight.
• Keep the device and the components in a clean, safe place.

• Protect the device from strong impact, such as when the device is dropped on the floor.

• Remove the batteries if the device is not being used for three months or longer. Always replace all the batteries simultaneously with new ones.

• This product is designed for use over a long period. However, it is generally advisable to check the device once in two years and calibrate it to ensure proper functioning and performance.

(* Pressure calibration is done by EU officials)

12. Troubleshooting

Error Possible causes	Troubleshooting
The device can not be connected to the smartphone	The Bluetooth connection of the smartphone is switched off	Switch on the Bluetooth connection on your smartphone.
	The phone does not support Bluetooth version 4.0 BLE	Use a compatible smartphone
The blood pressure monitor does not respond when the buttons are pressed	The device is in the wrong mode	Rest the device by pressing and holding the button for 5 seconds.
Blood pressure measurements are not being performed or are faulty.	The measurement is interrupted by arm movement or unexpected pressure on the pump.	Keep the arm still and do not press the plunger during the discharge measurement phase.
	An overflow is present in the press.	Check if the hose connection is loose.

13. Safety instructions and disclaimer

Never try to open the device to repair or make modifications. Avoid contact with the mains voltage. The device does not carry current only when it is disconnected. Do not short-circuit the product. Please disconnect the power cord when not in use or during storms.

The device is not approved for outdoor use. Therefore please use it only in dry surroundings. Protect it from high humidity, water and snow. Keep the device away from high temperatures. Do not expose the device to sudden changes in temperature or strong vibrations, as this could damage the electronic components. Check the device for any damage before using it. The device should not be used if it was subject to impact or has been damaged in some other manner. Please comply with the local regulations and restrictions. Do not use the device for purposes other than those described in the user manual.

This product is not a toy. Keep it out of the reach of children or mentally disabled persons. Any repair or modification to the device, which is not carried out by the original supplier, will void any warranty and guarantee claims. The device should only be used by those who have read and understood this user manual. The specifications of the device may be changed without any special prior notification.

14. Disposal instructions

In line with the European WEEE directive, electrical and electronic devices should not be disposed of along with domestic waste. Their components have to be separately sent for recycling or disposal, because improper disposal of toxic and dangerous components may permanently damage the environment.

According to the electrical and electronic equipment act (ElektroG), you are obliged (as a consumer) to return (free of charge) electrical and electronic devices to the manufacturer, the point of sale or public collection points at the end of their service life. The relevant local laws regulate the details in this regard. The symbol displayed on the product, in the user manual or/and on the packaging refers to these regulations. With this manner of sorting, recycling and disposal of used devices, you make an important contribution towards protecting our environment.

15. Instructions for battery disposal

In conjunction with the sale of batteries along with the supply of devices that include batteries, the supplier is obliged to point out the following to the customer: The customer is legally obliged to return used batteries. He can return used batteries which the supplier offers or has offered as new batteries in his assortment free of charge to the supplier's dispatch warehouse (shipping address). The symbols shown on the batteries indicate the following: Pb = battery contains more than 0.004 percent lead by weight, Cd = battery contains more than 0.002 percent cadmium by weight, Hg = battery contains more than 0.0005 percent mercury by weight.

Authorized representative: WellKang ltd

Address: The Black Church, St. Mary's Place, Dublin 7, D07 P4AX, Ireland

The symbol of the crossed-out dustbin means that the battery should not be disposed of in household waste.

0197

WEEE directive 2012/19/EU WEEE Register no.: DE 67896761

The company WD Plus GmbH hereby certifies that the device 305078 complies with the fundamental requirements and all other relevant stipulations of the directive 93/42/EEC. A complete conformity statement can be obtained from: WD Plus GmbH, Wohlenbergstraße 16, 30179 Hannover, http://downloads.ganzeinfach.de/search/model/305078

NOTE 2 The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 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.

NOTE 3 An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Radiated RF IEC 61000-4-3

10 V/m 80 MHz to 2.7 GHz

10 V/m

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 metres(m). Field strengths from fixed RF trans-mitters, as determined by an electromagnetic site survey, a should be less than the com- pliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol:

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 The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 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.

b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.

c 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 Model WDP-305078 is used exceeds the applicable RF compliance level above, the Model WDP-305078 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model WDP-305078. d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Frequency MHz	Maximum Power W	Distance	IEC 60601 Test Level	Com- pliance Level	Electromagnetic Environment - Guidance
2450	20.3		28 28		Where P is the maximum output power rating of the ransmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitter, as determined by an electromagnetic site survey, should be less than the com- pliance level in each frequency range.Interference may oc- cur in the vicinity of equipment marked with the following symbol:
5240	0.2 0.3 9 9
5500
5785
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Notes