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

USER MANUAL Sense Medel

Illustration of a human forearm with a bandage device attached to the wrist (no text or symbols visible)

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 cable with a circular component, no text or symbols present

MIN OK MAX

Pure diagram of a pipe fitting with an arrow indicating direction, no text or symbols present

Side profile illustration of a person using a pressure monitor (no text or symbols)

Illustration of a person sitting at a desk with crossed-out lines indicating pressure or stress (no text or symbols)

Quelle: WHO, 1999 (World Health Organization)

Illustration of a hand holding a wrist-mounted device (no text or symbols visible)

Medical illustration showing a hand holding a medical instrument with a catheter inserted, no text or symbols present

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

MIN OK MAX

Pure diagram of a pipe fitting with an arrow indicating direction, no text or symbols present

Side profile illustration of a person sitting at a desk using a pressure monitor (no text or symbols)

Simple line drawing of a person sitting at a desk with two crossed lines indicating no change or restriction (no text or symbols)

Fonte: WHO, 1999 (World Health Organization)

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.

Dear customer,

Thank you for choosing a product from our range. Our name is synonymous with high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, electrostimulation, beauty, baby and air.

With kind regards,

Your Medel team

Contents

1. Included in delivery.... 46
2. Signs and symbols.... 46
3. Intended use.... 47
4. Warnings and safety notes.... 48
5. Device description 51
6. Initial use 52

7. Usage 53

8. Cleaning and maintenance.... 59

9. Accessories and replacement parts.... 59
10. What if there are problems? 60
11. Disposal 60
12. Technical specifications ...... 61
13. Warranty/service 63

1. Included in delivery

Check that the exterior of the cardboard delivery packaging is intact and make sure that all 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 contents and contact your retailer or the specified Customer Service address.

1x blood pressure monitor

1x upper arm cuff (22-42 cm)

1x instructions for use

4x 1.5V AA LR6 batteries

1x storage bag

2. Signs and symbols

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

	WarningWarning notice indicating a risk of injury or damage to health
	ImportantSafety note indicating possible damage to the device/accessory

	Product informationNote on important information
	Observe the instructionsRead the instructions before starting work and/or operating devices or machines
	Isolation of applied parts, type BFGalvanically isolated application part (F stands for “floating”); meets the requirements for leakage currents for type BF
	Direct currentThe device is suitable for use with direct current only
	Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE
	Do not dispose of batteries containing hazardous substances with household waste
	Separate the packaging elements and dispose of them in accordance with local regulations.
[wZ68]A	Marking to identify the packaging material.A = Material code, B = Material number:1-7 = Plastics, 20-22 = Paper and card-board
	Separate the product and packaging elements and dispose of them in accordance with local regulations.
	Manufacturer
	Authorised Representative in the European Community
Storage/Transport	Permissible storage and transport temperature, humidity and ambient pressure
Operating	Permissible operating temperature, humidity and ambient pressure
IP21	Protected against solid foreign objects12.5 mm in diameter and larger, and against vertically falling drops of water
SN	Serial number

CE0123	CE labellingThis product satisfies the requirements of the applicable European and national directives
	Medical device
	Distributor
	Date of manufacturing
REF	Article number

3. Intended use

Intended use

The Medel SENSE automatic blood pressure monitor is indicated for home use for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.

Patient population: adults with upper arm size 22-42 cm.

Intended users: the use of the device does not require a specific knowledge or professional ability.

The patient is the intended operator, except in case of patients that require special assistance.

Indication/clinical benefits

The user can record their blood pressure and pulse values quickly and easily using the device. The recorded values are classified according to internationally applicable guidelines and evaluated graphically. Furthermore, the device can detect any irregular heart beats that occur during measurement and inform the user via a symbol in the display. The device saves the recorded measurements and can also output average values of previous measurements.

The recorded data can provide healthcare service providers with support during the diagnosis and treatment of blood pressure problems, and therefore plays a part in the long-term monitoring of the user's health.

4. Warnings and safety notes

Contraindications

• Do not use the blood pressure monitor on newborns, children or pets.

• People with restricted physical, sensory or mental skills should be supervised by a person responsible for their safety and receive instructions from this person on how to use the device.

• If you have any of the following conditions, it is essential you consult your doctor before using the device: cardiac arrhythmia, circulatory problems, diabetes, pregnancy, pre-eclampsia, hypotension, chills, shaking.

• People with pacemakers or other electrical implants should consult their doctor before using the device.
• The blood pressure monitor must not be used in connection with a high-frequency surgical unit.
• 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.
• 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 therapy, or an arteriovenous (AV) shunt.

General warnings

- 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 make your own medical decisions based on them (e.g. regarding dosages of medicines).

- 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 incorrect use.

• Using the blood pressure monitor outside your home environment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physical activity such as playing sport) can influence the measurement accuracy and cause incorrect measurements.
• Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy.
• Do not use the device at the same time as other medical electrical devices (ME equipment). This could lead to a malfunction of the device and/or an inaccurate measurement.
• Do not use the device outside of the specified storage and operating conditions. This could lead to incorrect measurements.
• Only use the cuffs included in delivery or cuffs described in these instructions for use for the device. Using another cuff may lead to measurement inaccuracies.
• Please note that when inflating the cuff, the functions of the limb in question may be impaired.
• Do not perform measurements more frequently than necessary. Due to the restriction of blood flow, some bruising may occur.

• 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.

• Place the cuff on your upper arm only. Do not place the cuff on other parts of the body.

• The air line poses a risk of strangulation for small children. Furthermore, included small parts pose a risk of suffocation for small children if swallowed. They should therefore always be supervised.

General precautions

• The blood pressure monitor is made from precision and electronic components. The accuracy of the measurements and service life of the device depend on its careful handling.
• Protect the device from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight.
• Ensure the device is at room temperature before measuring. If the measuring device has been stored close to the maximum or minimum storage and transport temperatures and is placed in an environment with a temperature of 20 °C, it is recommended that you wait approx. 2 hours before using the measuring device.
• 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.
• We recommend that the batteries be removed if the device is not to be used for a prolonged period of time.

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

Measures for 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 choke on batteries. Therefore, store batteries out of the reach of small children.
• Risk of explosion! Do not throw batteries into a fire.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• Do not disassemble, open or crush the batteries.

- Observe the plus (+) and minus (-) polarity signs.

- Protect the batteries from excessive heat.

- 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!

Notes on electromagnetic compatibility

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
• The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device's electromagnetic immunity; this can result in faulty operation.
• Failure to comply with the above can impair the performance of the device.

5. Device description

Blood pressure monitor and cuff

1 2 3 4 5 6 7 8 91011

1. Cuff
2. Cuff line
3. Cuff connector
4. Display

5. Connection for cuff connector

6. Risk indicator

7. Connection for mains part
8. Function buttons -/+
9. START/STOP button①
10. M memory button
11. SET button

Display

1. Time and date
2. Systolic pressure
3. Diastolic pressure
4. Calculated pulse rate
5. Cardiac arrhythmia symbol 🙏️ Pulse symbol ♥
6. Release air
7. Memory display: averagevalue (R), morning (RN), evening (PN), memory space number
8. Battery replacement symbol
9. Alarm function
10. Risk indicator
11. User memory
12. Cuff position control
13. Resting indicator display

13 12 11 10 9 8 7 6 5 4 3 2 1 AM 38:88 38/38 900 900 88 188

6. Initialuse

Inserting the battery

• Open the battery compartment lid.
• Insert four 1.5 V AA (alkaline type LR6) batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings.

Do not use rechargeable batteries.

• Carefully close the battery compartment lid again.
• 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. Any saved measured values are retained.

Operation with the mains part

You can also operate this device with a mains part. However, before connecting the device with the mains part, please ensure that you have removed the batteries from the device. During mains operation, there must not be any batteries in the battery compartment, as this could damage the device.

• To avoid any potential damage, the device may only be operated with a mains part that meets the specifications described in the chapter “Technical specifications”.
• Furthermore, the mains part must only be connected to the mains voltage that is specified on the type plate.
• Insert the mains part into the connection provided for this purpose on the right-hand side of the blood pressure monitor.
• Then insert the mains plug of the mains part into the mains socket.
• After using the blood pressure monitor, unplug the mains part from the mains socket first and then disconnect it from the blood pressure monitor. As soon as you unplug the mains part, the blood pressure monitor loses the date and time setting but the saved measured values are retained.

Setting the hour format, date and time

It is essential that you 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.

There are two different ways to access the menu from which you can adjust the settings:
- Before initial use and after each time you replace the battery:

When inserting batteries into the device, you will be taken to the relevant menu automatically.

- If the batteries have already been inserted: With the device switched off, press and hold the SET button for approx. 5 seconds.

To set the date and time, proceed as follows:

• 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 SET button.
• The blood pressure monitor switches itself off automatically.

Setting the alarm

You can set 2 different alarm times to remind yourself to take the measurement. To set the alarm, proceed as follows:

• Press and hold the function buttons - and + simultaneously for 5 seconds.

• Alarm 1 📄 shown in the display; “on” or “off” flashes at the same time. With the function buttons -/+ , choose whether alarm 1 🔊 should be activated (“on” flashes) or deactivated (“off” flashes) and confirm with the SET button.

• If alarm 1 deactivated ("off") you automatically switch to setting alarm 2

• If alarm 1 is activated, the hours flash on the display. Select the desired hour using the function buttons - / + and confirm with SET. The minutes flash on the display. Select the desired minute using the function buttons - / + and confirm with SET.
• Alarm 2 shown in the display, "on" or "off" flashes at the same time. To set, proceed as for alarm 1 The blood pressure monitor switches itself off automatically.

7. Usage

General rules when measuring blood pressure yourself

• In order to generate as informative a profile of the progression of your blood pressure as possible and ensure that the measured values can be compared, you should measure your blood pressure regularly and always at the same times of day. It is recommended that you measure your blood pressure twice a day: once in the morning after getting up and once in the evening.
• You should always carry out the measurement when you are sufficiently physically rested. You should therefore avoid taking measurements during stressful periods.

• Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.

• Before the initial blood pressure measurement, make sure always to rest for 5 minutes.

• Furthermore, if you want to take several measurements in succession, make sure always to wait for at least 1 minute between the individual measurements.
• Repeat the measurement if you are unsure of the measured value.

Attaching the cuff

• Fundamentally, blood pressure can be measured on both arms. Certain deviations between the measured blood pressure on the right arm and left arm are due to physiological causes and completely normal. You should always perform the measurement on the arm with the highest blood pressure values. Before starting self-measurement, consult your doctor in this regard. From this point on, always take measurements on the same arm.
• The device may only be operated with one of the following cuffs. This should be selected in accordance with your upper arm circumference. The fit should be checked before measurement using the index mark described below.

Ref. no. Designation Arm	circumference
164.324* Universal cuff 22-42 cm

* Included in standard delivery

• Place the cuff onto the bare 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 here.

- Guide the end of the cuff that is sticking out through the metal ring, fold it back over the arm and close the cuff using the hook-and-loop fastener. The cuff should be fastened tightly, but not too tightly, so that two fingers can still fit under the closed cuff.

- The cuff is suitable for you if the index mark (▼) is within the OK range after fitting the cuff.

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

Illustration of a person using a medical or surgical instrument to interact with a leg (no text or symbols visible)

Illustration of a hand holding a cable or wire inserted into a circular component (no text or symbols visible)

MIN OK MAX

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

Pure diagram of a pipe fitting with an arrow indicating direction, no text or symbols present

Adopting the correct posture

• To carry out a blood pressure measurement, make sure you are sitting upright and comfortably. Lean back and place your arm on a surface. Do not cross your legs. Place your feet next to each other flat on the floor.
  • Always make sure that the cuff is at heart level.
• To avoid distorting the measurement, you should remain as still as possible during the measurement and not speak.

Side profile illustration of a person sitting at a desk using a pressure monitor (no text or symbols)

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 ① After the full-screen display, the respective alarm symbols are displayed if alarm 1 is activated.

• The cuff automatically inflates. The cuff's air pressure is slowly released. If a tendency for high blood pressure is detected, the cuff re-inflates and the cuff's pressure is increased 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 “Erate displayed. In such cases, the measurement is cancelled after approx. 5 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. A symbol in the display also appears which shows you whether you were sufficiently relaxed during the blood pressure measurement or not (symbol = sufficiently at rest; symbol = not at rest). Observe the chapter “evaluating the results/resting indicator measurement” in these instructions for use.

• 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/trouble-shooting 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 ① If you forget to turn off the device, it will switch itself off automatically after approx. 3 minutes.

Wait for at least 1 minute before taking another measurement.

Evaluating the results

General information about blood pressure

• Blood pressure is the force with which the bloodstream presses against the arterial walls. Arterial blood pressure constantly changes in the course of a cardiac cycle.
• Blood pressure is always stated in the form of two values:
• The highest pressure in the cycle is called systolic blood pressure. This arises when the heart muscle contracts and blood is pumped into the blood vessels.
• The lowest is diastolic blood pressure, which is when the heart muscle has completely stretched back out and the heart fills with blood.
• Fluctuations in blood pressure are normal. Even during repeat measurements, considerable differences between the measured values may occur. One-off or irregular measurements therefore do not provide reliable information about the actual blood pressure. Reliable assessment

is only possible when you perform the measurement regularly under comparable conditions.

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 🤨 appears frequently, please consult your doctor. Only they are able to determine any arrhythmia during an examination.

Risk indicator

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 device 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
Level 3: severe hypertension	red ≥18	0≥110		Seek medical attention
Level 2: moderate hypertension	orange	160–179100	-109	Seek medical attention
Level 1: mild hypertension	yellow	40–15990	-99	Regular monitoring by doctor
High normal	green	30–13985	-89	Regular monitoring by doctor
Normal green	120–1	2980–84	Self-monitoring
Optimal green	<120	<80		Self-monitoring

Source: WHO, 1999 (World Health Organization)

Resting indicator measurement (using HSD diagnostics)

The most frequent error made when measuring blood pressure is taking the measurement when not at rest (haemodynamic stability), which means that both the systolic and the diastolic blood pressures are incorrect in this case. While measuring the blood pressure, the device automatically determines whether you are at rest or not. If there is no indication that the circulatory system is not sufficiently at rest, the

symbol (haemodynamic stability) appears in the display and the measurement can be recorded as a reliable blood pressure at rest value.

Haemodynamically stable

The systolic and diastolic pressure measurements have been recorded when the circulatory system is sufficiently at rest and are a very reliable indicator of resting blood pressure.

However, if there is an indication that the circulatory system is not sufficiently at rest (haemodynamic instability), the symbol appears in the display. In this case, the measurement should be repeated after a period of physical and mental rest. The blood pressure measurement must be taken when the patient is physically and mentally rested, as it will be the basis for diagnosing the blood pressure level and therefore regulating the patient's medical treatment.

Lack of haemodynamic stability

It is very probable that the systolic and diastolic blood pressures have been measured whilst the patient was not at rest and the measurements therefore deviate from the blood pressure at rest. Repeat the measurement after a minimum period of 5 minutes' rest and relaxation. Go to a sufficiently quiet and comfortable spot and remain there calmly; close your eyes, breathe deeply and evenly and try to relax. If the next measurement also shows insufficient stability, you can repeat the measurement after another resting period. If the measurements continue to show some instability, identify these blood pressure measurements as having been taken when the circulatory system had not been sufficiently rested. In this case, nervousness or inner anxiety may be the cause and this cannot be cured by brief periods of rest. Existing cardiac arrhythmias may also prevent a stable blood pressure measurement. A lack of resting blood pressure can have various causes, such as physical or mental strain or distraction, speaking or experiencing cardiac arrhythmias during the blood pressure measurement. In an overwhelming number of cases, the HSD diagnosis will give a very good guide as to whether the circulatory system is rested when taking the measurement. Certain patients suffering from cardiac arrhythmia or chronic mental conditions can remain haemodynamically unstable in the long term, something which persists even after repeated periods of rest. The accuracy of the blood pressure at rest results is reduced in these users. Like any medical measurement method, the precision of the HSD diagnosis is limited and can lead to incorrect results in some cases. The blood pressure measurements taken when the circulatory system was at rest represent particularly reliable results.

Saving, accessing 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 am – 9 am, 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 pm – 8 pm, 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 button ①.

• 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 the memory button M and the SET button simultaneously for 5 seconds.

8. Cleaning and maintenance

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

9. Accessories and replacement parts

Accessories and replacement parts are available from the corresponding service address (according to the service address list). Please state the corresponding order number.

Designation Item number and/	or order number
Universal cuff (22-42 cm)(Material: Polyester)	164.324
Mains part (EU) 071.95
Mains part (UK) 072.05

1. What if there are problems?

Error mes-sage	Possible cause	Solution
E1	Unable to re-cord a pulse.	Please wait one minute and repeat the measurement.Ensure that you do not speak or move during the measure-ment.
E2	You moved or spoke during the measure-ment.
E3	The cuff was not attached correctly.	Please observe the information in chapter “Attaching the cuff”.
E4	An error oc-curred during the measure-ment.	Please wait one minute and repeat the measurement.Ensure that you do not speak or move during the measure-ment.
E5	The inflation pressure is higher than 300 mmHg.	Please take another meas-urement to check whether the cuff can be correctly inflated.Make sure that neither your arm nor other heavy objects are pressing on the line, and that the line is not bent.
E6	There is a sys-tem error.	If this error message ap-pears, please contact Cus-tomer Services.
	The batteries are almost empty.	Insert new batteries into the device.

11. Disposal

i Repairing and disposing of the device

• Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.
• Do not open the device. Failure to comply will invalidate the warranty.
• Repairs must only be carried out by Customer Services or authorised retailers. Before making a claim, please check the batteries first and replace them if necessary.
• For environmental reasons, do not dispose of the device in household waste at the end of its service life. Dispose of the device at a suitable local collection or recycling point in your country. Dispos the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you any questions, please contact the local authorities responsible for waste disposal.

⚠ Disposing of the batteries

- 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.

12. Technical specifications

Model Medel SENSE

Type GCE602
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 uncertainty	Max. permissible standard deviationaccording to clinical testing:systolic 8 mmHg /diastolic 8 mmHg
Memory 4 x 30 memory spaces
Dimensions L 134 mm x W 103 mm x H 60 mm

Weight Approximately 367 g (without batteries, with cuff)
Cuff size 22 to 42 cm
Noise ≤54dBA
Current ≤450mA
Service life 20.000 measurements
Permissible operating conditions	+10 °C to +40 °C, 10 to 85% relative humidity (non-condensing), 800-1050 hPa ambient pressure
Permissible storage conditions	-20 °C to +55 °C, 10 to 90% relative humidity, 800-1050 hPa ambient pressure
Power supply	4 x 1.5V —— AA batteries
Battery life	For approx. 300 measurements, depending on levels of blood pressure and pump pressure
Classification	Internal supply, IP21, no AP or APG, continuous operation, application part type BF

The batch number is located on the device or in the battery compartment.

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

• This device conforms with the European standard EN 60601-1-2 (in accordance with CISPR 11, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-7, IEC 61000-4-8, IEC 61000-4-11, EN 55024) and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device.
• This device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and IEC 80601-2-30 (Medical electrical equipment – Part 230: 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 the device is used 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.

Mainspart

Model no. LXCP12-006060BEH

Input 100–240 V, 50–60 Hz, 0.5 A max

Output 6 V DC, 600 mA, in conjunction with Medel blood pressure monitors only
Manufacturer	Shenzhen longxc power supply co., Ltd.
Protection	This device is double protected and has a primary-side cutout switch which disconnects the device from the mains in case of malfunction.Ensure that you have removed the batteries from the battery compartment before you use the mains part.
	Polarity of the DC voltage connection
	Insulated/protection class 2
Housing and protective covers	The housing of the mains part protects users from touching live parts or parts that could be live (for example with their fingers, or with a needle or checking hook).The user must not touch the patient and the output connector of the AC/DC mains part at the same time.

13. Warranty/service

Medel International, via Villapizzone 26 / 20156, Milan (referred to as "Medel") provides a warranty for this prod-

uct, subject to the requirements below and to the extent described as follows.

The warranty conditions below shall not affect the seller's statutory warranty obligations which ensue from the sales agreement with the buyer.

The warranty shall apply without prejudice to any mandatory statutory provisions on liability. Medel guarantees the perfect functionality and completeness of this product.

The worldwide warranty period is 5 years, commencing from the purchase of the new, unused product from the seller. The warranty only applies to products purchased by the buyer as a consumer and used exclusively for personal purposes in the context of domestic use.

German law shall apply.

During the warranty period, should this product prove to be incomplete or defective in functionality in accordance with the following provisions, Medel shall carry out a repair or a replacement delivery free of charge, in accordance with these warranty conditions

If the buyer wishes to make a warranty claim, they should approach their local retailer in the first instance: see the attached “International Service” list of service addresses.

The buyer will then receive further information about the processing of the warranty claim, e.g. where they can send the product and what documentation is required. A warranty claim shall only be considered if the buyer can provide Medel, or an authorised Medel partner, with

- a copy of the invoice/purchase receipt, and

- the original product.

The following are explicitly excluded from this warranty:

- deterioration due to normal use or consumption of the product;

- accessories supplied with this product which are worn out or used up through proper use (e.g. batteries, rechargeable batteries, cuffs, seals, electrodes, light sources, attachments and nebuliser accessories);

- products that are used, cleaned, stored or maintained improperly and/or contrary to the provisions of the instructions for use, as well as products that have been opened, repaired or modified by the buyer or by a service centre not authorised by Medel;

- damage that arises during transport between manufacturer and customer, or between service centre and customer;

- products purchased as seconds or as used goods;

- consequential damage arising from a fault in this product (however, in this case, claims may exist arising from product liability or other compulsory statutory liability provisions).

Repairs or an exchange in full do not extend the warranty period under any circumstances.

Please report any serious incident that has occurred in relation to the device injury or adverse event to the local competent authority and to the Manufacturer or to the European Authorised Representative (EC REP)

Vigilance contact point: https://ec.europa.eu/growth/sectors/medical-devices/contacts/

Subject to errors and changes

FRANÇAIS

Mesures relatives aux piles

Illustration of a human hand holding a wristwatch (no text or symbols visible)

Medical illustration showing a hand holding a medical device near a human leg (no text or symbols visible)

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

MIN OK MAX

Pure diagram of a pipe fitting with an arrow indicating direction, no text or symbols present

Side profile illustration of a person using a pressure monitor (no text or symbols)

Illustration of a person sitting at a desk with crossed-out lines indicating no text or symbols (no text or symbols present)

Mesurer la tension artérielle

Source : WHO, 1999 (World Health Organization)

Point de contact vigilance: https://ec.europa.eu/growth/sectors/medical-devices/contacts/

Illustration of a human wrist with a bandage device attached (no text or symbols)

Illustration of a medical procedure showing a hand holding a tool near a human leg, with no visible text or symbols.

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

MIN OK MAX

Pure diagram of a pipe fitting with an arrow indicating direction, no text or symbols present

Side profile illustration of a person using a pressure monitor (no text or symbols)

Illustration of a person sitting at a desk with arms crossed out, no text or symbols present

Fuente: WHO, 1999 (World Health Organization)

IEC 60601-1-2-2014 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for Class B product

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.

Warning: Don't near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation."

Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MEDEL SENSE including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

If any: a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).

If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term "ESSENTIAL PERFORMANCE" need not be used).

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.

2. Guidance and manufacturer's declaration -electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test Compliance
RF emissionsCISPR 11	Group 1
RF emissionsCISPR 11	Class B
Harmonic emissionsIEC 61000-3-2	Class A
Voltage fluctuations/ flicker emissionsIEC 61000-3-3	Compliance

Table 2

Guidance and manufacturer's declaration - electromagnetic Immunity
Immunity test IEC 60601-1-2	Test level Compliance level
Electrostatic discharge (ESD) ±8 kV contact	±2 kV, ±4 kV, ±8 kV, ±15 kV air	±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transient/burst Power supply lines: ±2 kV100 kHz repetition frequency		Power supply lines: ±2 kV
SurgeIEC 61000-4-5	line(s) to line(s): ±1 kV. line(s) to line(s): ±1 kV.	100 kHz repetition frequency
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11	0% 0.5 cycleAt 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315°0% 1 cycleAnd70% 25/30 cyclesSingle phase: at 00% 250 cycle	0% 0.5 cycleAt 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°0% 1 cycleAnd70% 25/30 cyclesSingle phase: at 00% 250 cycle
Power frequency magnetic fieldIEC 61000-4-8	30 A/m50Hz/60Hz	30 A/m50Hz/60Hz
Conduced RFIEC61000-4-6	150KHz to 80MHz: 3Vrms6Vrms (in ISM and amateur radio bands)80% Am at 1kHz	150KHz to 80MHz: 3Vrms6Vrms (in ISM and amateur radio bands)80% Am at 1kHz
Radiated RFIEC61000-4-3	10 V/m80 MHz – 2,7 GHz80 % AM at 1 kHz	10 V/m80 MHz – 2,7 GHz80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.

Table 3

Guidance and manufacturer's declaration - electromagnetic Immunity
Radiated RFIEC61000-4-3(Test specifications forENCLOSURE PORTIMMUNITY toRF wireless communications equipment)	TestFrequency(MHz)	Band(MHz)	Service Modulation Modulation		(W)	Distance(m)	IMMUNITYTEST LEVEL(V/m)
	385 380 -	390	TETRA 400 Pulse modulation18 Hz		1.8 0.3 27
	450 430 -	470	GMRS 460,FRS 460		± 5kHz deviation1 kHz sine	2 0.3 28
	710 704 -	787	LTE Band13,17		Pulse modulation217 Hz	0.2 0.3 9
	745
	780
	810 800 -	960	GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5	Pulse modulation 18 Hz	2 0.3 28
	870
	930
	1720 1700	1990	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS	Pulse modulation 217 Hz	2 0.3 28
	1845
	1970
	2450 2400	2570	Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7	Pulse modulation 217 Hz	2 0.3 28
	5240 5100	5800	WLAN 802.11 a/n	Pulse modulation 217 Hz	0.2 0.3 9
	5500
	5785

Manufacturer:

Globalcare Medical Technology Co., Ltd.

7th Building, 39 Middle Industrial Main Road

European Industrial Zone, Xiaolan Town

528415 Zhongshan City, Guangdong Province P.R.C.

Phone : [phone]

http://www.globalcare.com.hk/contact/

EC REP

EC-Representative:

Donawa Lifescience Consulting Srl

Piazza Albania, 10

00153 Rome / Italy

https://www.donawa.com/wli/main/contatti.index

Distributed by:

Beurer GmbH

Söflinger Str. 218

89077 Ulm, Germany