Control - Blood pressure monitor Medel - Free user manual and instructions

USER MANUAL Control Medel

model c.20 c.25 c.30 c.35 c.40 c.45 ±100 120 80 ±100 +100

CONTROL

EN Blood pressure monitor Instructions for use....27-37

Illustration of a wristwatch with a bandage and wrist, no text or symbols present

Illustration of a person's leg with a medical device attached, showing a curved line and foot (no text or symbols)

Illustration of a hand holding a medical or electrical device with a curved cable (no text or symbols visible)

Illustration showing three different positions of a person performing a task: seated, holding a device, and lying on the floor.

11. Customer Service

Illustration of a hand holding a cable with a circular component, no text or symbols present

Illustration showing three different positions of a person's leg and arm, with one leg highlighted by an X symbol.

Quelle: WHO, 1999 (World Health Organization)

1. Getting to know your device 27
2. Important notes.... 28
3. Device description.... 31
4. Preparing the measurement 32
5. Measuring blood pressure.... 32
6. Evaluating results ...... 34
7. Saving, displaying and deleting measured values ..... 35
8. Error messages/troubleshooting 36
9. Cleaning and storing the unit 36
10. Technical specifications .... 36

Dear customer,

Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products. Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.

With kind regards,

Your Medel team

1. Getting to know your device

Check that the packaging of the Medel Control blood pressure monitor has not been tampered with and make sure that all the required contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.

The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults.

This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing cardiac arrhythmia. The recorded values are classified and evaluated graphically. Store these instructions for use for future reference and make them accessible to other users.

2. Important notes

Signs and symbols

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and the accessories:

	Attention
	NoteNote on important information
	Observe the instructions for use
	Application part, type BF
	Direct current
	Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE
	Manufacturer

-20°C	Permissible storage temperature and humidity
10°C	Permissible operating temperature and humidity
	Protect from moisture
	Serial number
CE0123	The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.

Notes on use

• In order to ensure comparable values, always measure your blood pressure at the same time of day.
• Before every measurement, relax for about five minutes.
• If you want to perform several measurements on the same person, wait five minutes between each measurement.
• Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.
• Repeat the measurement if you are unsure of the measured value.

• The measured values taken by you are for your information only – they are no substitute for a medical examination. Discuss the measured values with your doctor and never base any medical decisions on them (e.g. medicines and their administration).
• Do not use the blood pressure monitor on newborns or patients with pre-eclampsia. We recommend consulting a doctor before using the blood pressure monitor during pregnancy.
• Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills or shaking.
• The blood pressure monitor must not be used in connection with a high-frequency surgical unit.
• Only use the device on people who have the specified upper arm measurement for the device.
• Please note that when inflating, the functions of the limb in question may be impaired.
• During the blood pressure measurement, the blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions remove the cuff from the arm.

• Avoid any mechanical restriction, compression or bending of the cuff line.

• Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.

• Make sure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular or therapy, or an arteriovenous (AV) shunt.
• Do not use the cuff on people who have undergone a mastectomy.
• Do not place the cuff over wounds as this may cause further injury.
• The blood pressure monitor can only be operated with batteries.
• To conserve the batteries, the blood pressure monitor switches off automatically if you do not press any buttons for 30 seconds.
• The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or careless use.

Instructions for storage and maintenance

- The blood pressure monitor is made from precision and electronic components. The accuracy of the measured values and service life of the device depend on its careful handling:

• Protect the device from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight.
• Do not drop the device.
• Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.
• Only use the cuff included with the delivery or original replacement parts. Otherwise incorrect measured values will be recorded.
• Do not press the buttons before the cuff is placed on the arm.
• We recommend that the batteries be removed if the device will not be used for a prolonged period of time.

Notes on handling batteries

- If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.

Choking hazard! Small children may swallow and woke on batteries. Store the batteries out of the reach of small children.

• Observe the plus (+) and minus (-) polarity signs.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• Protect batteries from excessive heat.

Risk of explosion! Never throw batteries into a fire.

• Do not charge or short-circuit batteries.
• If the device is not to be used for a relatively long period, take the batteries out of the battery compartment.
• Use identical or equivalent battery types only.
• Always replace all batteries at the same time.
• Do not use rechargeable batteries.
• Do not disassemble, split or crush the batteries.

Instructions for repairs and disposal

• Batteries do not belong in household waste. Please dispose of empty batteries at the collection points intended for this purpose.
• Do not open the device. Failure to comply will result in voiding of the warranty.
• Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.
• Repairs must only be carried out by Customer Services or authorised suppliers. Before making a claim, please check the batteries first and replace them if necessary.
• For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic

Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.3.

Device description

1 2 3 5 4 6 7 10 9 8

1. Cuff
2. Cuff line
3. Cuff connector
4. Display
5. Connection for cuff connector
6. Scale for classifying the measurements
7. Function buttons -/+
8. START/STOPbutton①
9. Memory button M
10. Setting button SET

Information on the display:

< 38:88 38/38 OK 10 9 1 2 3 4 8 7 6 5 88 M -188

1. Time and date
2. Systolic pressure
3. Diastolic pressure
4. Calculated pulse value
5. Cardiac arrhythmia symbol
6. Memory display: average value (R), morning (A), evening (P), memory space number
7. Release air
8. User memory
9. Battery replacement symbol
10. Classification of measurements
11. Cuff position control

4. Preparing the measurement Inserting the batteries

• Open the battery compartment lid.
• Insert four 1.5V AA (alkaline type LR6) batteries. Make sure that the batteries are inserted the correct way round. Do not use rechargeable batteries. 4 × 1.5V AA (LR6).

- Close the battery compartment lid again carefully.

- All display elements are briefly displayed, 24 h flashes in the display. Now set the date and time as described below.

4 x 1,5V AA (LR6)

If the low battery indicator is permanently displayed, you can no longer perform any measurements and must replace the batteries. Once the batteries have been removed from the device, the time must be set again.

Battery disposal

- The empty, completely flat batteries must be disposed

of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.

- The codes below are printed on batteries containing harmful substances:

Pb = Battery contains lead,

Cd = Battery contains cadmium,

Hg = Battery contains mercury

Setting the hour format, date and time

It is essential to set the date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later.

To set the date and time, proceed as follows:

• Insert the batteries, or press and hold the setting button SET for at least 5 seconds if the batteries have already been inserted.
• Select 12h or 24h mode using the function buttons -/+. Press SET to confirm. The year display will start to flash. Set the year with the function buttons -/+ and confirm with SET.
• Set the month, day, hour and minute and confirm each with the setting button SET.
• The blood pressure monitor switches itself off automatically.

5. Measuring blood pressure

Ensure the device is at room temperature before measuring.

Attaching the cuff

Place the cuff on to the bare left upper arm. The circulation of the arm must not be hindered by tight clothing or similar.

The cuff must be placed on the upper arm so that the bottom edge is positioned 2 - 3 cm above the elbow and over the artery. The line should point to the centre of the palm.

Now tighten the free end of the cuff, but make sure that it is not too tight around the arm and close the hook-and-loop fastener. The cuff should be fastened so that two fingers can fit under the cuff.

Now insert the cuff line into the connection for the cuff connector.

Important: The unit may only be operated with the original cuff. The cuff is suitable for an arm circumference of 22 to 42 cm.

Adopting the correct posture

• Before every measurement, relax for about five minutes. Otherwise deviations can occur.
• You can take the measurement while sitting or lying. Always make sure that the cuff is at heart level.
• To carry out a blood pressure measurement, make sure you are sitting comfortably with your arms and back leaning on something. Do not cross your legs. Place your feet flat on the ground.
• To avoid falsifying the measurement, it is important to remain still during the measurement and not to speak.

Performing the blood pressure measurement

• As described above, attach the cuff and adopt the posture in which you want to perform the measurement.
• Start the blood pressure monitor with the START/STOP button Ⓙ
• The cuff automatically inflates. The cuff's air pressure is slowly released. If you already recognise a tendency for high blood pressure, you should reinflate the cuff and

increase the cuff's pressure again. As soon as a pulse is found, the pulse symbol 🤊will be displayed.

• The cuff position control symbol is displayed throughout the entire measurement. If the cuff is applied too tightly or too loosely, then and " " are displayed. In such cases, the measurement is cancelled after approx. 30 seconds and the device switches itself off. Apply the cuff correctly and take a new measurement.
• The systolic pressure, diastolic pressure and pulse rate measurements are displayed.
• You can cancel the measurement at any time by pressing the START/STOP button ^1
• E_- appears if the measurement has not been performed properly. Observe the chapter on error messages/troubleshooting in these instructions for use and repeat the measurement.
• Now select the desired user memory by pressing the memory button M. If you do not select a user memory, the measurement is stored in the most recently used user memory. The relevant symbol appears on the display.
• To switch off, press the START/STOP button Ⓓ. If you forget to turn off the device, it will switch itself off automatically after approx. 3 minutes.

Wait at least 5 minutes before taking another measurement.

6. Evaluating results

Cardiac arrhythmia:

This device can identify potential disruptions of the heart rhythm when measuring and if necessary, indicates this after the measurement with the symbol 🚫This can be an indicator for arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnormal because of flaws in the bioelectrical system that regulates the heartbeat. The symptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical make-up, excess stimulants, stress or lack of sleep. Arrhythmia can only be determined through an examination by your doctor. If the symbol 🚫s shown on the display after the measurement has been taken, repeat the measurement. Please ensure that you rest for 5 minutes beforehand and do not speak or move during the measurement. If the symbol 🚫pears frequently, please consult your doctor. Self-diagnosis and treatment based on the measurements can be dangerous. Always follow your GP's instructions.

Classification of measurements:

The measurements can be classified and evaluated in accordance with the following table.

However, these standard values serve only as a general guideline, as the individual blood pressure varies in different people and different age groups etc.

It is important to consult your doctor regularly for advice.

Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous.

The bar chart on the display and the scale on the unit show which category the recorded blood pressure values fall into. If the values of systole and diastole fall into two different categories (e.g. systole in the High normal category and diastole in the Normal category), the graphical classification on the device always shows the higher category; for the example given this would be High normal.

Blood pressure value category	Systole (in mmHg)	Diastole (in mmHg)	Action
Setting 3: severe hypertension	≥180≥110		seek medical attention
Setting 2: moderate hypertension	160–179	00–109	seek medical attention
Setting 1: mild hypertension	140–159	0–99	regular monitoring by doctor

Blood pressure value category	Systole (in mmHg)	Diastole (in mmHg)	Action
High normal 130–	13985–89		regular monitoring by doctor
Normal 120–129	80–84 self-monitoring
Optimal <120<80	self-monitoring

Source: WHO, 1999 (World Health Organization)

7. Saving, displaying and deleting measured values

The results of every successful measurement are stored together with the date and time. If there are more than 30 measurements, the oldest measurements are lost.

• Press the memory button M. Select the desired user memory (☐) by pressing the memory button M again.
• If you press the function button +, the average value R of all the stored measured values in the user memory will be displayed. If you press the function button + again, the average value of the morning measurements for the last 7 days will be displayed (morning: 5 a.m. - 9 a.m., display R). If you press the function button + again, the average value of the evening measurements for the last 7 days will be displayed (evening: 6 p.m. - 8 p.m., display P). If you continue to press the function button +, the most recent

individual measured values are displayed in turn with the date and time.

• To switch off, press the START/STOP button①.
• If you forget to switch off the device, it will switch itself off automatically after 30 seconds.
• If you want to delete the whole memory for a specific user, press the memory button M. Press and hold down the memory button M and the setting button SET simultaneously for 5 seconds.

8. Error messages/troubleshooting

In the event of errors, the error message E_ appears on the screen.

Error messages may appear if:

• It was not possible to correctly record the pulse: E1;
• No measurement could be taken: E 2;
• The cuff is fastened too tightly or loosely: E3;
• Errors occur during the measurement: E 4;
• The pump pressure is higher than 300 mmHg: E 5;
• There is a system error. If this error message appears, please contact Customer Services: E6.
• The batteries are almost empty:

In such cases, repeat the measurement. Ensure that you do not move or speak.

If necessary, reinsert or replace the batteries.

9. Cleaning and storing the unit

• Clean your blood pressure monitor carefully using a slightly damp cloth only.
• Do not use any cleaning agents or solvents.
• Under no circumstances should you hold the device under water, as this can cause liquid to enter and damage the device.
• If you store the unit, no heavy objects should be placed on top of it. Remove the batteries. The cuff line should not be bent sharply.

10. Technical specifications

Model No. Medel Control

Measurement method	Oscillometric, non-invasive blood pressure measurement on the upper arm
Measurement range	Cuff pressure 0-300 mmHg,Systolic 50-280 mmHg,Diastolic 30-200 mmHg,Pulse 40-180 beats/minute

Display accuracy Systolic ± 3 mmHg, Diastolic ± 3 mmHg, Pulse ± 5% of the value shown

Measurement inaccuracy	Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg
Memory 4 x 30 memory spaces
Dimensions L 112 mm x W 110 mm x H 58 mm
Weight Approximately 219 g (without batteries and cuff)
Cuff size	22 to 42 cm
Permissible operating conditions	+10°C to +40°C, 15 to 85% relative humidity (non-condensing)
Permissible storage conditions	-20°C to +55°C, 10-90% relative humidity, 800-1050 hPa ambient pressure
Power supply 4 x 1.5 V AA batteries
Battery life For approx. 300 measurements, depending on levels of blood pressure and pump pressure
Accessories Instructions for use, 4 x 1.5V AA batteries, storage bag
Classification Internal supply, IPX0, no AP or APG, continuous operation, application part type BF

Technical information is subject to change without notification to allow for updates.

• This device complies with European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Services address or found at the end of the instructions for use.
• The device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN1060-1 (Non-invasive sphygmomanometers – Part 1: General requirements), EN1060-3 (Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC80601-2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).
• The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.

FRANÇAIS

Sommaire

Illustration of a wristwatch with a bandage and wrist, no text or symbols present

Illustration of a person's leg with a medical device attached to the ankle (no text or symbols present)

Illustration of a hand holding a cable with a circular component, no text or symbols present

Medical illustration showing three different positions of a person's leg and arm, with one leg highlighted by a cross symbol.

Illustration of a hand performing a blood pressure measurement on a forearm (no text or symbols present)

Illustration of a human wrist with a bandage and wrist, no text or symbols present

Illustration of a person receiving a medical or therapeutic procedure on a leg, with no visible text or symbols.

Diagram showing a pipe fitting with an arrow pointing to a curved structure (no text or symbols)

Illustration of a hand holding a medical device with a circular component (no text or symbols visible)

Illustration of a wristwatch with a bandage and wrist, no text or symbols present

Illustration of a wristwatch with a bandage and wrist, no text or symbols present

Illustration of a person's leg with a medical instrument inserted, showing a curved line and foot (no text or symbols)

Diagram showing a pipe fitting with an arrow pointing to a curved structure (no text or symbols)

Illustration of a hand holding a medical device with a circular component (no text or symbols)

Illustration of a wristwatch with a bandage and wrist, no text or symbols present

Illustration of a person's leg with a medical device attached, showing a force or pressure application (no text or symbols present)

Illustration of a hand holding a medical device with a circular component (no text or symbols visible)

Electromagnetic emissions

Guidance and manufacturer's declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS

The Blood pressure monitor Medel Control is intended for use in the electromagnetic environment specified below. The customer of the user of the Blood pressure monitor Medel Control should assure that it is used in such and environment.

Emission test	Compliance	Electromagnetic environment-guidance
RF emissions CISPR 11	Group 1 The B	blood pressure monitor Medel Control uses RF energy only for its internal func-tion.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11	Class B The B	blood pressure monitor Medel Control is suitable for use in all establishments, includingdomestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electromagnetic immunity

Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS

The Blood pressure monitor Medel Control is intended for use in the electromagnetic environment specified below. The customer of the user of the Blood pressure monitor Medel Control should assure that it is used in such and environment.

Immunity test IEC 60601test level		Compliance level	Electromagnetic environment–guidance
Electrostatic discharge (ESD)IEC 61000-4-2	±6 kV contact ±8 kV air	±6 kV contact ±8 kV air	Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency (50Hz) magnetic fieldIEC 61000-4-8	3A/m	3A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer's declaration – electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

The Blood pressure monitor Medel Control is intended for use in the electromagnetic environment specified below. The customer

or the user of Blood pressure monitor Medel Control should assure that it is used in such an environment.

Immunity test IEC 60601test level		Compliancelevel	Electromagnetic environment–guidance
			Portable and mobile RF communications equipment should be usedno closer to any part of the Blood pressure monitor Medel Control,including cables, than the recommended separation distancecalculated from the equation applicable to the frequency of thetransmitter.Recommended separation distance.
Conducted RFIEC 61000-4-6	3 V _rms 150 kHz to80 MHz	3 V _rms
Radiated RFIEC 61000-4-3	3 V/m80 MHz to2.5 GHz	3 V/m	80 MHz to 800 MHz
			800 MHz to 2.5 GHz

			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 transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:[IMAGE]
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 Blood pressure monitor Medel Control is used exceeds the applicable RF compliance level above, the Blood pressure monitor Medel Control should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Blood pressure monitor Medel Control. ^b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFESUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the Blood pressure monitor Medel Control.

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

Rated maximum output power of transmitter (W)	Separation distance according to frequency of transmitter (m)
	80 MHz to 800 MHz d = [ 3.5E_1 ]	800 MHz to 2.5 GHz d = [ 7E_1 ]
0,01 0.1167 0.2334
0,1 0.3689 0.7378
1 1.1667 2.3334
10 3.6893 7.3786
100 11.6667 23.3334

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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.

Manufacturer:

Globalcare Medical Technology Co., Ltd 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town 528415 Zhongshan City, Guangdong Province PEOPLE'S REPUBLIC OF CHINA

EC-EP EC- Representative:

Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome / Italy

Distributed by:

Medel International Srl Via Villapizzone 26 - 20156 Milano / Italy

CE0123