beurer BC 54 Wrist Blood Pressure Monitor Instruction Manual

beurer BC 54 Wrist Blood Pressure Monitor

Product Information

The BC 54 Wrist Blood Pressure Monitor is distributed by Beurer North America LP. It is a high-quality and thoroughly tested product designed for measuring blood pressure on the wrist. Beurer is known for producing reliable products in various areas such as heating, weight management, blood pressure, body temperature, pulse, gentle therapy, massage, and beauty.

Product Usage Instructions

1. Before using the BC 54 Wrist Blood Pressure Monitor, it is important to read the entire user manual carefully and completely.
2. Keep the user manual in a safe location for future reference.
3. To access instructions in Spanish, refer to page 22 of the manual.
4. If you have any questions or comments, you can contact the US-based customer service toll-free at 1-800-536-0366.
5. Displaying and Deleting Measurements: Refer to page 14 for instructions on how to view and delete measurements.
6. Care and Maintenance: Follow the guidelines provided on page 15 to ensure proper care and maintenance of the blood pressure monitor.
7. Troubleshooting Guide: If you encounter any issues with the product, consult the troubleshooting guide on page 16 for possible solutions.
8. Technical Specifications: Detailed technical specifications can be found on page 17.
9. FCC Compliance Information: For information regarding FCC compliance, refer to page 18.
10. Warranty: Details about the warranty can be found on page 19.
11. If the instruction manual is damaged or lost, contact customer service for a replacement. See the warranty section for service contact details.
    It is important to observe all safety instructions and warnings provided in the manual to avoid hazardous situations and ensure= correct use of the BC 54 Wrist Blood Pressure Monitor.

SAVE THESE INSTRUCTIONS FOR FUTURE REFERENCE
If the instruction manual is damaged or if you no longer have the instruction manual in your possession, please contact customer service. See warranty for service contact.

Dear Valued Customer,
Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for application in the areas of heating, weight management, blood pressure, body temperature, pulse, gentle therapy, massage, and beauty.

Register your product today to receive further benefits:

• added protection for your purchase
• health and wellness tips
• new product information
• continual outstanding customer service and support.

CONTACT

• Visit www.registerbeurer.com or contact customer service at 1-800-536-0366.
• Please read these instructions for use carefully and keep them for later use. Make them accessible to other users and observe the information they contain.
• With kind regards,
• Your Beurer team

IMPORTANT SAFETY NOTES

Signs and symbols
Whenever used, the following signs identify safety and property damage messages and designate a level of hazard or seriousness.
READ THIS ENTIRE MANUAL, THE SAFETY SECTION AND ALL INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY INSTRUCTIONS AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT.

WARNING – To reduce the risk of fire, electric shock, or serious personal injury:

• For consistency, always measure your blood pressure at the same time each day.
• Before each measurement, relax for about five minutes.
• When performing multiple measurements on an individual, wait at least 5 minute between each measurement.
• Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.
• The time (30 min) required for the ME EQUIPMENT to warm from the minimum storage temperature -20°C between uses until the ME EQUIPMENT is ready for its INTENDED USE when the ambient temperature is 20 °C .
• The time (30 min) required for the ME EQUIPMENT to cool from the maximum storage temperature +60°C between uses until the ME EQUIPMENT is ready for its INTENDED USE when the ambient temperature is 20 °C.
• Repeat the measurement if you are unsure of the results.
• Measurements are for your information only – they are no substitute for a medical examination. Discuss the measurements 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. Consult your doctor before using the blood pressure monitor during pregnancy.
• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Supervise children around the device to ensure they do not play with it.
• Cardiovascular diseases may lead to incorrect 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.
• 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 cuffs. Otherwise incorrect measured values will be recorded.
• 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.
• People with pacemakers or other electrical implants should consult their doctor before using the device.
• 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 or therapy, or an arteriovenous (AV) shunt.
• 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.
• Do not perform measurements more frequently than necessary. The resulting restriction of the blood flow may cause injury.
• Place the cuff on your wrist only. Do not place the cuff on other parts of the body.
• 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.

CAUTION – To reduce the risk of personal injury or product/ property damage:

• 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.

NOTICE:

• Do not wash the unit in a washing machine, dish washer or tumble dryer.
• Never immerse and or spill water or any other liquid onto the monitor or any components, otherwise liquid will enter it and cause damage.
• Never attempt to repair, open and/or disassemble the unit (including wrist cuff and optional accessory) or adjust it yourself. This may damage the unit and impair the functions. If you need to have the unit repaired, please contact our customer service. Please see warranty for service contact. Before submitting any complaint, first check the batteries and replace them if necessary.
• Changes or modifications to the device will nullify the user warranty.
• Do not press the buttons with excessive force or with pointed objects.
• Only use the device on people who have the specified wrist measurement for the device.
• We recommend that the batteries be removed if the device is not to be used for a prolonged period.

Battery Handling Safety Precautions

• Use only the size and type of batteries specified.
• Be sure to follow the correct polarity when installing the batteries. Reversed batteries may cause damage to the device.
• Do not mix different types of batteries together (e.g. Alkaline and Carbon-zinc or rechargeable batteries) or old batteries with fresh ones. Always replace batteries as a simultaneous set.
• If the batteries in the device are depleted or the device will not be used for a long period of time, remove the batteries to prevent damage or injury from possible battery leakage.
• Do not try to recharge batteries not intended to be recharged; they can overheat and rupture (follow battery manufacturer’s directions.)
• Do not dispose of batteries in fire, batteries may explode or leak.
• Clean the battery contacts and also those of the device prior to battery installation.
• Remove discharged batteries from the product and dispose/recycle in compliance with all applicable laws.
• Keep batteries away from children and pets. Batteries may be harmful if swallowed. Should a child or pet swallow a battery, seek medical assistance immediately.
• If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
• Do not disassemble, open or crush the batteries.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

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.

INDICATIONS FOR USE

This blood pressure monitor performs non-invasive measurement and monitoring of arterial blood pressure and heartbeat rate in adults with a wrist circumference raging from 5.3 – 8.5 in. You can use it to measure your blood pressure quickly and easily, store the results, and display stored readings and their average. This device also features an irregular heartbeat indicator and average blood pressure results classified and compared to industry guidelines.

PACKAGE CONTENTS

• 1 x Wrist blood pressure monitor with cuff
• 1 x Storage box
• 2 x 1.5 V Unnecessary AAA batteries
• 1 x Quick start guide
• 1 x Instruction manual

PARTS AND CONTROLS

1. LCD Display
2. START/STOP Button
3. M1 Button
4. M2 Button
5. Wrist Cuff
6. Battery Compartment (on rear)
7. Blood Pressure Classification Scale

LCD Display Information

1. Blood Pressure Classification Indicator
2. Bluetooth® Indicator
3. Time and Date
4. Systolic Pressure
5. Diastolic Pressure
6. Pulse Rate
7. Irregular Heartbeat Indicator/Pulse Rate Icon
8. Low Battery Indicator
9. Deflation Indicator
10. User Number Indicators
11. Memory Space Number/Memory Display of Average (A), Morning (M), or Evening (E)

PREPARING FOR MEASUREMENT

Inserting/changing batteries:

1. Remove the Battery Compartment Cover from the rear of the device.
2. Insert two “AAA” alkaline batteries (included) according to the polarity markings inside the compartment. NOTE: Do not use rechargeable batteries.
3. Reattach the Battery Compartment Cover.
4. Before first use, remove the clear plastic film from the LCD Display.

All LCD Display elements will briefly appear and “24h” will flash. Set the date and time as described below. Any saved measurements will be retained.

Setting the hour format, date, and time:
If date and time are not set, stored measurements will not have a valid timestamp associated with them.
NOTE: Press and hold the M1 or M2 Buttons to advance values rapidly.

1. If “24h” is not flashing in the LCD Display, press and hold the START/STOP Button for five seconds.

2. Select an hour format (12 or 24 hour display) with the M1 or M2 Button and press the START/STOP Button to confirm.

3. The year flashes on the LCD Display. Set the year with the M1 or M2 Button and press the START/STOP Button to confirm.

4. The month flashes on the LCD Display. Set the month with the M1 or M2 Button and press the START/STOP Button to confirm.

5. The day flashes on the LCD Display. Set the day with the M1 or M2 Button and press the START/STOP Button to confirm. NOTE: If the hour format is set to 12h, the day/month display sequence is reversed.

6. The hour flashes on the LCD Display. Set the hour with the M1 or M2 Button and press the START/STOP Button to confirm.

7. The minutes flash on the LCD Display. Set the minutes with the M1/M2 Buttons and press the START/STOP Button to confirm.

8. “bt” will appear on the LCD Display.Turn Bluetooth on or off using the M1/M2 Buttons; the Bluetooth symbol will appear in the upper left corner of the LCD Display when it is activated.
   NOTE: Battery drain is increased slightly when Bluetooth is on.

9. Press the START/STOP Button to confirm and exit; the LCD Display will shut off.

MEASURING BLOOD PRESSURE

The blood pressure monitor needs to be at room temperature when measuring. Measurements can be performed on the left or right wrist.

Attaching the Cuff:

1. With your palm up, place the cuff around your left wrist.
2. Position the cuff about half an inch (0.4 in) below the bottom of your hand.
3. Secure the cuff with the hook and loop strip so that it fits snugly but does not affect blood circulation.

Correct Posture:

1. Rest for at least five minutes before each measurement.

2. Perform the measurement either sitting or lying down. Always make sure that the cuff is level with your heart.

3. To perform a measurement, sit comfortably with your arms and back supported. Do not cross your legs and place your feet flat on the floor.

4. Keep still during the measurement and do not talk.

Performing a Measurement:

1. With the device shut off, press M1 or M2 to select a User Number and confirm by pressing the START/STOP Button.
2. With the cuff attached properly and in a correct posture, press the START/STOP Button. All LCD Display elements will briefly display and measurement will begin after about five seconds. To cancel a measurement at any time, press the START/STOP Button again.
3. As the measurement concludes, the cuff will deflate. The pulse symbol will display, along with systolic and diastolic pressure.
4. “Er_” will appear if the measurement was not performed properly. Refer to the “Troubleshooting Guide” section for details about specific error message numbers.
5. Press the START/STOP Button to shut off the blood pressure monitor. The measurement is now stored in the selected user memory. The device will also shut off automatically after about three minutes.
6. If the Bluetooth function is on, data will transfer after pressing the START/STOP Button; the Bluetooth icon will flash in the LCD Display and the unit will try to connect to the HealthManager app on your Bluetooth device for about 30 seconds.
7. When Bluetooth pairing is successful, the icon will display steadily and all measurement data is transferred. The unit will then shut off.
8. If a Bluetooth pairing is not found, the icon will disappear from the LCD Display and the unit will shut off after about three minutes.
9. Wait at least five minutes before taking another measurement.

EVALUATING RESULTS

• Irregular Heartbeat:
  This device can detect irregular heartbeat patterns during measurement and will indicate them by displaying the Irregular Heartbeat Indicator . This may be an indicator for arrhythmia, a condition where the heart rhythm is abnormal. These symptoms (omitted or premature heartbeats, slow or excessively fast heart rate) may be caused, among other things, by heart disease, age, physical predisposition, excessive use of stimulants, stress, or lack of sleep. Only your doctor can determine if you do have arrhythmia.

• Repeat the measurement if the Irregular Heartbeat Indicator displays after a measurement. Rest for at least five minutes between measurements and do not talk or move during measurement. If the Indicator appears often, contact your doctor, since self-diagnosis and treatment based solely on the test results may be dangerous. It is vital to follow your doctor‘s instructions.

Risk Classification
Measurements can be classified and assessed by the table below. However, these standard values are only a general guideline, since individual blood pressure varies in different people and different age groups, etc.

Hypertension Category| Systolic

(in mmHg)

| Diastolic

(in mmHg)

| LED Risk Indicator
---|---|---|---
Grade 3: Severe hypertension| ≥ 180| ≥ 110| Red
Grade 2: Moderate hypertension|

160 – 179

|

100 – 109

|

Orange

---|---|---|---
Grade 1: Mild hypertension| 140 – 159| 90 – 99| Yellow
High Normal| 130 – 139| 85 – 89| Green
Normal| 120 – 129| 80 – 84| Green
Optimal| < 120| < 80| Green

Source: WHO, 1999
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 classification on the display and the scale on the unit show which category the recorded blood pressure values fall into. If the systolic and diastolic values fall into two different categories, the Risk Classification Indicator on the device always shows the higher category.

DISPLAYING AND DELETING MEASUREMENTS

User Memory:

• Every successful measurement is stored along with its date and time. If there are more than 60 measurements, the oldest measurement is deleted.
• With the unit shut off, press the M1 or M2 Button to select a user memory and then confirm by pressing the Start/Stop Button. If Bluetooth is activated, the device will attempt to connect to the mobile app. If a connection is achieved, the buttons are deactivated, the Bluetooth icon disappears from the LCD Display, and data is transferred. To cancel Bluetooth transfer, press the M1 or M2 Button.

Average Values:

• AA flashes on the display. The average of all saved measurements in the selected user memory is displayed.

• Press the M1 Button again. AMAM flashes on the display. The average value of the morning measurements for the last seven days is displayed (morning: 5:00 AM – 9:00 AM).

• Press the M1 Button a third time. PMPM flashes on the display. The average value of the evening measurements for the last seven days is displayed (evening: 6:00 PM – 8:00 PM).

Individual Measured Values:

• Press the M1 Button again and the last individual measurement is displayed. Keep pressing the M Button to cycle through all the stored individual measurements.
• To shut the device off, press the START/STOP Button.
  You can exit the menu at any time by pressing the START/STOP Button.

Clearing Memory:

• To clear one of the user memories, you must first select it.
• Start individual measurement access as described above and select a user memory.
• Press and hold the M1 and M2 Buttons for five seconds. All values in the selected user memory will be deleted.

Transfer via Bluetooth®
In addition to displaying and saving measurements locally on the blood pressure monitor itself, you can also transfer measurements to your mobile device via Bluetooth®. To do so, you will need to install the “beurer HealthManager Pro” app. The app is freely available in either the Apple App Store or Google Play Store.

System requirements:

• iOS ≥ 14.0, Android ≥ 8.0
• Bluetooth® ≥ 4.0

FOR MORE INFO
For a list of compatible devices, scan the QR Code below:

To transfer the measured values, proceed as follows:

•  Start the app and follow the instructions.
• Select the blood pressure monitor in the app.
• Confirm the pairing request on your smartphone.
• Make sure the “beurer HealthManager Pro” app on your smartphone is always activated and open before you start data transfer from the blood pressure monitor.
• Data transfer is in progress when the Bluetooth® symbol flashes on the LCD Display.

CARE AND MAINTENANCE

• Clean the device and cuff with a slightly moistened cloth.
• Do not use detergents or solvents.
• Never immerse the device in water or other liquids.
• When storing the device, make sure no heavy objects are placed on top of it. Remove the batteries.

Disposal
Observe the local regulations for material disposal. Dispose of the device in accordance with local regulations. If you have any questions, please contact the local authorities responsible for waste disposal.

TROUBLESHOOTING GUIDE

In case of faults, “Er” appears in the LCD Display, where “” is a number from 1-8. Error messages may appear if:

TECHNICAL SPECIFICATIONS

the wrist
Measurement Range| Cuff pressure 0-299 mmHg, Systolic 60-230 mmHg,

Diastolic 40-130 mmHg,

Pulse 40-199 beats/minute

Display Accuracy| Pressure ± 3 mmHg, Pulse ± 5%
Dimensions| 3.16 in L x 2.73 in W x 0.98 in H (80.5 mm L x 69.5 mm W x

25 mm H)

Weight| 4 oz (116 g) without batteries
Cuff Size| 5.3 in – 8.5 in (135 – 215 mm)
Operating Range| 41 °F – 104 °F (5 °C – 40 °C),

≤ 90% relative humidity (non-condensing)

Storage Range

| -4° F – 140° F (-20° C – 60° C),

≤ 93% relative humidity at a water vapour pressure up to 50 hPa

An atmospheric pressure range of 500 hPa to 1060 hPa

---|---
Power Supply| Two AAA Batteries
Battery Life| Approx. 150 measurements
Amount of user| up to 2 users
Measurements per

user

| 60 memory spaces per user

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

FCC COMPLIANCE INFORMATION

• Wrist Blood Pressure Monitor BC 54
• Responsible Party – U.S. Contact Information
• Beurer North America LP
• 1 Oakwood Boulevard, Suite 255
• Hollywood, FL 33020
• United States
• 1-800-536-0366
• [email protected]

FCC Compliance Statement

• This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

  1. this device may not cause harmful interference
  2. this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

• NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be
  encouraged to try to correct the interference by one or more of the following measures:

  • Reorient or relocate the receiving antenna.
  • Increase the separation between the equipment and receiver.
  • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Consult the dealer or an experienced radio/TV technician for help.

WARRANTY

Limited Lifetime Warranty For Original Purchaser

• Your Beurer Wrist Blood Pressure Monitor, BC 54, is warranted to be free from defects in materials and workmanship for the life of the product under normal conditions of intended use and service. This warranty extends only to the original retail purchaser and does not extend to retailers or subsequent owners.

• We will, at our option, repair or replace the Beurer Wrist Blood Pressure Monitor, BC 54, without additional charge, for any part or parts covered by these written warranties. No refunds will be given. Repair or replacement is our only responsibility and your only remedy under this written warranty. If replacement parts for defective materials are not available, Beurer reserves the right to make product substitutions in lieu of repair or replacement.

• For warranty service contact our customer service department at 1-800-536-0366 or at [email protected] to provide a description of the problem. If the problem is deemed to be within the scope of the limited lifetime warranty, you will be asked to mail the product at your costs in its original package with proof of purchase, your name, address and phone number. If the problem is not deemed to be within the scope of the limited lifetime warranty, we will provide a quotation for repair respectively replacement and return shipping fee.

• This warranty does not cover damage caused by misuse or abuse; accident; the attachment of unauthorized accessory; alteration to the product; improper installation; misapplication; lack of reasonable care with respect to the product; unauthorized repairs or modifications; improper use of electrical/power supply; old worn batteries; normal wear; loss of power; dropped product; malfunction or damage of an operating part as a result of failure to comply with instructions for use or to provide manufacturer’s recommended maintenance; transit damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of Beurer. This warranty is void if the product is ever used in a commercial or business environment. The maximum liability of Beurer under this warranty is limited to the purchase price actually paid by the customer for the product covered by the warranty, as confirmed by proof of purchase, regardless of the amount of any other direct or indirect damage suffered by the customer.

• This warranty is effective only if the product is purchased and operated in the country in which the product is purchased. A product that requires modifications or adaptation to enable it to operate in any other country than the country for which it was designed, manufactured, approved and/or authorized, or repair of products damaged by these modifications is not covered under this warranty.

• THE WARRANTY PROVIDED HEREIN SHALL BE THE SOLE AND EXCLUSIVE WARRANTY. ANY IMPLIED WARRANTIES, OBLIGATIONS, OR LIABILITES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE DURATION OF THIS APPLICABLE WRITTEN WARRANTY. Some states do not allow limitations on how long an implied warranty lasts, so the above limitations may not apply to you.

• IN NO EVENT SHALL BEURER BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES FOR BREACH OF THIS OR ANY OTHER WARRANTY, EXPRESS, IMPLIED OR ANY OTHER THEORY OF LIABILITY, WHATSOEVER. Some states do not allow the exclusion or limitation of special, incidental, or consequential damages, so the above limitation may not apply to you.

• Beurer does not authorize anyone, including, but not limited to, retailers, the subsequent consumer purchaser of the product from a retailer or remote purchaser, to obligate Beurer in any way beyond the terms set forth herein.

• This warranty does not extend to the purchase of opened, used, repaired, repackaged and/or resealed products, including but not limited to sale of such products on Internet auction sites and/or products by surplus or
  bulk resellers. Any and all warranties or guarantees shall immediately cease and terminate in connection with any products or parts thereof which are repaired, replaced, altered, or modified, without the prior explicitly written consent of Beurer.

• This warranty gives you specific legal rights, and you may also have other rights which may vary from state to state.

For more information regarding our product line in the USA, please visit: www .shop-beurer.com

Distributed by:

• Beurer North America LP
• 1 Oakwood Boulevard, Suite 255
• Hollywood, FL 33020, USA
• www.shop-beurer.com
• Questions or comments? Call our US-based customer service toll free at 1-800-536-0366.
• Assembled in China

EMC Guidance

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments

• Warning: Don’t use 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 specfied 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 equipment, including cables specfied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description

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

Table 2
Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2

Test level

| Compliance level
---|---|---
Electrostatic discharge (ESD) IEC 61000-4-2| ±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 IEC 61000-4-4| Not applicable| Not applicable
Surge

IEC 61000-4-5

| Not applicable| Not applicable
Voltage dips, short interruptions and voltage variations on

power supply input lines

IEC 61000-4-11

| Not applicable| Not applicable
Power frequency magnetic field IEC 61000-4-8| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

Immunity Test| IEC 60601-1-2

Test level

| Compliance level
---|---|---
Conducted RF IEC61000-4-6| Not applicable| Not applicable
Radiated RF IEC61000-4-3| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/m

80 MHz – 2,7 GHz

80 % 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 RF IEC61000-4-3

(Test specifications for ENCLOSURE

PORT IMMUNITY

to RF wireless communications equipment)

| Test frequency (MHz)| Band (MHz)| ****

Service

| ****

Modulation

| Maximum Power (W)| Distance (m)| Test Level (V/m)| Compliance level

(V/m)

---|---|---|---|---|---|---|---|---

385

| ****

380-390

| ****

TETRA 400

| Pulse modulation 18 Hz| ****

1,8

| ****

0.3

| ****

27

| ****

27

450

| ****

430-470

| GMRS 460,

FRS 460

| FM ± 5 kHz

deviation 1 kHz sine

| ****

2

| ****

0.3

| ****

28

| ****

28

710| ****

704-787

| ****

LTE Band 13, 17

| Pulse modulation 217 Hz| ****

0.2

| ****

0.3

| ****

9

| ****

9

745
780
810| ****

900-960

| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| ****

Pulse modulation 18 Hz

| ****

2

| ****

0.3

| ****

28

| ****

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

| ****

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

| ****

28

5240| ****

5100-5800

| ****

WLAN 802.11

a/n

| Pulse modulation 217 Hz| ****

0.2

| ****

0.3

| ****

9

| ****

9

5500
5785

References

• Product Registration | Product Registration
• Beurer – Beurer North America

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