SBM 50 - Blood pressure monitor SANITAS - Free user manual and instructions

Frequently Asked Questions - SBM 50 SANITAS

USER MANUAL SBM 50 SANITAS

Electromagnetic Compatibility Information....74–77

Serviceadresse:

Hans Dinslage GmbH

Riedlinger Straße 28

88524 Uttenweiler, GERMANY

Simple line drawing of a mechanical component with two upward arrows indicating motion (no text or symbols)

4 x 1,5V AA (LR6)

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

Illustration of a person's arm with a medical device attached, showing body and leg anatomy (no text or symbols)

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

Pure technical line drawing of a mechanical component without any text, numbers, or symbols

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.

1. Getting to know your instrument

The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure.

You can use it to measure your blood pressure quickly and easily, storing the results and displaying the progression of readings together with the average.

A warning is issued for anyone suffering from cardiac arrhythmia.

The values determined are classified and graphically evaluated according to WHO guidelines.

Keep these instructions carefully for further use and also let other users have access to them.

2. Important information

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 accessories:

	Caution
	NoteNote on important information
	Follow instructions for use
	Type BF applied part
—	Direct current
	Disposal in accordance with EC Directive 2002/96/EC – WEEE (Waste Electrical and Electronic Equipment).
	Manufacturer
Storage	Temperature limitation
	Permissible storage humidity
	Keep dry
SN Serial	number
	The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.

Advice 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 after eating, drinking, smoking or exercising.

• Repeat the measurement if you are unsure of the measured value.

• The measurements taken by you are for your information only – they are not a 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 preeclampsia. 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, 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.
• Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access 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.
• You can either use the blood pressure monitor with batteries or with a mains part. Please note that data transfer and data storage is only possible when your blood pressure monitor is supplied with power. As soon as the batteries are empty or the mains part is disconnected from the power supply, the blood pressure monitor loses the date and time.
• To conserve the batteries, the monitor switches off automatically if no buttons are pressed for one minute.
• 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.

Storage and Care

• The blood pressure monitor is made up of precision electronic components. Accuracy of readings and the instrument's service life depend on careful handling.
• You should protect the device from impact, moisture, dirt, major temperature fluctuations and direct exposure to the sun's rays.
• Never drop the device.
• Do not use near strong electromagnetic fields, i.e. keep it away from any radio systems and mobile phones.
• Only ever use the cuffs provided with the monitor or original replacement cuffs. Otherwise erroneous results will be recorded.
• Do not press any buttons until the cuff is in position.
• If the instrument is not used for any length of time, we recommend removing the batteries.

Advice on batteries

• Batteries can be fatal if swallowed. You should therefore store the batteries and products where they are inaccessible to small children. If a battery has been swallowed, call a doctor immediately.

• Batteries should not be charged or reactivated with any other means, nor should they be taken apart, thrown in the fire or short-circuited.

• Remove the batteries from the instrument if they are worn out or if you are not going to use the instrument for any length of time. This prevents any damage as a result of leakage. Always replace all the batteries at the same time.

• Never use different types of battery, battery brands or batteries with different capacities. You should preferably use alkaline batteries.

i Repair and disposal

• Batteries do not belong in domestic refuse. Used batteries should be disposed of at the collection points provided.
• Never open the instrument. If these instructions are not heeded, the warranty will be null and void.
• Never attempt to repair the instrument or adjust it yourself. We can no longer guarantee perfect functioning if you do.
• Repairs may only be performed by Customer Service or authorized dealers. However, always check the batteries and replace them if necessary prior to making any complaint.
• The appliance should be disposed of according to Regulation 2002/96/EC – WEEE (Waste Electrical and Electronic Equipment). In case of queries, please contact the municipal authorities responsible for waste disposal in your area.

3. unit description

1 2 3 4 5 7 8 MEM 9 10

1. Cuff tube
2. Cuff
3. Cuff connector
4. USB interface
5. Touch screen activation switch
6. Cuff holder
7. Cuff connector port (left side)
8. Memory button MEM
9. START/STOP button①
10. Mains part port
11. Display

5 4 6

Touch screen activation switch

The device features a touch screen display. To prevent the screen from being activated accidentally, keep the touch screen activation switch set to OFF when the device is not in use. To operate the device, move the touch screen activation switch to ON. When the touch screen display is touched (START/STOP button or MEM button), a beep is output.

You can switch off the device at any time by setting the touch screen activation switch to the OFF position.

Cuff holder

Thanks to the cuff holder on the underside of the device, you have the option of conveniently storing the cuff. To do so, push out the cuff holder with both thumbs until it locks into place (see also Chapter: Inserting battery).

Icons in the display:

1. Time and date
2. Systolic pressure
3. Diastolic pressure
4. Measured pulse
5. Pump up, release air (arrow)
6. Memory display, average value, morning, evening, Number of memory space
7. WHO classification

8 9 1 3 1 2 1 7 N 188 188 3 2 4 6 5

1. "Change battery" icon

2. Arrhythmia recognition

PC interface

The blood pressure monitor also allows you to transfer your measured values to the PC.

To do this, you need a regular USB 2.0 cable [USB type A to USB Mini-B] and the "HealthCoach" PC software.

The software can be downloaded free of charge from the download area under Service at www.sanitas-online.de.

System requirements for the "HealthCoach" PC software

1. Supported operating systems:

2. Windows XP SP3
   • Windows Vista SP1 or later

3. Windows 7
4. Windows 7 SP1

5. Windows 8

6. Supported architectures:

7. x86 (32 bit)

8. x64 (64 bit)

9. Hardware requirements:

10. Recommended: at least Pentium 1 GHz or faster with at least 1 GB RAM

11. Free memory on the primary partition of at least: - x86 - 600 MB

- x64 - 1.5 GB

• Graphic resolution from: 1024 x 768 pixels
- USB port 1.0 or later

4. Prepare measurement

Inserting battery

• Push the cuff holder upwards at the rear of the device until it locks into place.
• Open the battery compartment lid.
• Insert four AA 1.5 V alkaline batteries. mak-

Simple line drawing of a mechanical component with two upward arrows and a base (no text or symbols)

4 x 1,5V AA (LR6)

ing absolutely sure that you insert them with the correct polarity as marked. Never use rechargeable batteries.

- Replace the battery cover carefully.

If the battery change continuously illuminated, measurement is no longer possible and you must replace all the batteries. Once batteries have been removed from the device, the time must be reset.

Used batteries do not belong in the household waste. You are legally obliged to dispose of the batteries. Dispose of them via your specialist electrical supplier or local collecting point for recyclable waste.

Batteries containing pollutant substances are marked as follows: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury.

Setting date and time

You should set the date and time without fail. Otherwise, you will not be able to save your measured values correctly with a date and time and to access them again later.

Tip: If you press and hold the MEM button, you can set the values more quickly.

To set the date and time, proceed as follows:

- Move the touch screen activation switch to the ON position.

- Press the START/STOP and MEM buttons simultaneously, 24h begins to flash. Select 12h or 24h mode using the MEM button. Press START/STOP to confirm your selection. The year display will start to flash. Set the year with the MEM button and confirm with START/STOP ⏻

- Then set the month, day, hour and minutes and confirm each setting with START/STOP ①

- Pressing the START/STOP button 📋 again will switch the display off.

Note: In 24h mode, the date is displayed as day/month. In 12h mode, as month/day.

Operation with the mains part

You can also operate this device with a mains part.

When doing so, there must not be any batteries in the battery compartment. The mains part can be obtained from specialist retailers or from the service address using order number 071.19.

• To prevent possible damage to the device, the blood pressure monitor must only be used with the mains part described here.
• Insert the mains part into the connection provided for this purpose on the right-hand side of the blood pressure monitor. The mains part must only be connected to the mains voltage that is specified on the type plate.
• 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 measurements are retained.

5. Measuring blood pressure

Please ensure the device is at room temperature before measuring.

Positioning cuff

Fit the cuff round your bare left upper arm. Blood circulation in the arm should not be restricted by tight clothing or other objects.

The cuff should be placed on the upper arm so that the lower edge is 2 to 3 cm above the bend of the elbow and above the artery. The tube should be in line with the centre of the palm.

Now place the free end of the cuff snugly, but not too tightly, around the arm, and fix it with the Velcro fastener. The cuff should be fitted tight enough to allow just two fingers to fit beneath the cuff.

Insert the cuff tubing into the socket for the cuff attachment.

Important: The instrument should only be operated with the original cuff. The cuff is suitable for an arm circumference of 22 to 30 cm. A larger cuff for upper arm circumferences from 30 to 42 cm is available from retailers or the service address under order no. 162.796.

Illustration showing two-step medical procedure: one of a hand using an arm buffer, the other of a person holding a medical device with tubing (no text or symbols present)

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

Pure technical line drawing of a mechanical component without any text, numbers, or symbols

Correct posture

• Rest for approx. 5 minutes before each measurement. Otherwise there may be divergences.
• You can perform the measurement either sitting or lying down. Always make sure that the cuff is on a level with your heart.
• 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.
• In order not to distort the result, it is important to keep still during the measurement and not talk.

Measuring blood pressure

• Move the touch screen activation switch to the ON position.
• Put on the cuff as described previously and assume the position in which you want to carry out the measurement.
• Switch on the blood pressure monitor with the START/STOP button. After the full-screen display, the most re-

cently used user memory appears (UI or UP) To change the user memory, press the MEM button and confirm your selection with the START/STOP button. If no button is pressed, the most recently used user memory is automatically used after 5 seconds.

• Before the measurement, the last saved test result is briefly displayed. If there is no measurement in the memory, the instrument always displays the value 0
• The cuff automatically inflates. Cuff air pressure is released slowly. If a tendency towards high blood pressure is already detectable, the cuff is pumped up again and cuff pressure increased further. As soon as a heart rate is detected, the heart rate symbol is displayed.
• Heart rate, systolic and diastolic blood pressure are displayed.
• You can cancel the measurement at any time by pressing the START/STOP button or by pushing the touch screen activation button to OFF.
• Erappears if it has not been possible to perform the measurement properly. Observe the section in these instructions on error messages/troubleshooting and repeat the measurement.
• The test result is saved automatically.
• To switch off the device, press the START/STOP button or push the touch screen activation switch to OFF. If you

forget to switch off the device, it switches off automatically after approx. 1 minute.

Wait at least 5 minutes before taking another measurement!

6. Evaluating results

Cardiac arrhythmia:

This instrument can identify possible cardiac arrhythmia disorders during measurement and if necessary indicates the measurement with the flashing icon 🤨. This may be an indicator for arrhythmia. Arrhythmia is a condition where the heart rhythm is abnormal as a result of defects in the bioelectrical system controlling the heart beat. The symptoms (omitted or premature heart beats, 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. Arrhythmia can only be ascertained through examination by your doctor. Repeat the measurement if the flashing icon 🤨 displayed after the measurement. Please note that you should rest for 5 minutes between measurements and not talk or move during the measurement. If the icon 🤨 appears often, please contact your doctor. Any self-diagnosis and treatment based on the test results may be dangerous. It is vital to follow your doctor's instructions.

WHO classification:

In accordance with the guidelines/definitions of the World Health Organization and the latest findings, the measurements can be classified and assessed according to 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.

Range of blood pressure values	Systolic (in mmHg)	Diastolic (in mmHg)	Measure
Grade 3: Severe hypertension	≥ 180 ≥ 110	Seek medical advice
Grade 2: Moderate hypertension	160–179 100–109	Seek medical advice
Grade 1: Mild hypertension	140–159 90–99	Have it checked regularly by doctor
High-normal 130–	139 85–89	Have it checked regularly by doctor
Normal 120–129	80–84	Check it yourself
Optimal <120<80	Check it yourself

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 WHO classification in the display shows the range of the measured blood pressure.

If the values for systolic and diastolic pressure are in two different WHO ranges (e.g. systolic in the grade hypertension range and diastolic pressure in the normal range), the WHO classification on the unit always indicates the higher range (grade hypertension in the example described).

7. Saving, retrieving and deleting results

• The results of each successful measurement are stored together with date and time. With more than 60 items of measured data, the earliest items of data measured are lost.
• Move the touch screen activation switch to the ON position.
• Make a selection with the MEM button, and then confirm the desired user memory with the START/STOP button. If you press the MEM button again, the average value R of all the stored measured values in the user memory will be displayed. If you press the MEM button again, the average value of the last 7 days for the morning measurement will be displayed (Morning: 5 a.m. – 9 a.m., display RIf you press the MEM button again, the average value of the last 7 days for the evening measurement will be displayed (Evening: 6 p.m. – 8 p.m., display PIf you continue to

press the MEM button, the most recent individual measured values with date and time are displayed in turn.

• You can delete the memory by pressing and holding the MEM button for 3 seconds. All the values in the current user memory are deleted after three beeps are output.
• To switch off the device, press the MEM button again or the START/STOP button or push the touch screen activation switch to OFF.
• If you forget to switch off the device, it will switch off automatically after 2 minutes.

8. Transferring measurements

Connect the blood pressure monitor to your PC using the USB cable. Activate the device by pressing the MEM button and use the START/STOPP button to select the desired user memory. Start the data transfer using the PC software.

i After two minutes of not being in use or if communication with the PC is interrupted, the blood pressure monitor switches itself off automatically.

9. Error messages/trouble-shooting

In case of faults, the Ermessage appears in the display. Error messages may appear if:

- systolic or diastolic pressure could not be measured (Er I or E appears on the display)

• the cuff is fastened too tightly or loosely (Eor ap-4 pears on the display)
• the pump pressure is higher than 300 mmHg (ErE appears on the display)
• pumping up takes longer than 160 seconds (E appears on the display)
• there is a system or device error (ErA, EorD Er7 Er8 appears on the display)
• the batteries are almost empty

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

If necessary, re-insert or replace the batteries.

i Technical alarm – description

Should the recorded blood pressure (systolic or diastolic) lie outside the limits specified in the section "Technical specifications", the technical alarm will appear on the display indicating either "Hi" or "Lo". In such cases, you should seek medical assistance and check the accuracy of your procedure.

The limit values for the technical alarm are factory set and cannot be adjusted or deactivated. These alarm limit values are accorded second priority under the standard IEC 60601-1-8.

The technical alarm is a non-locking alarm and must not be reset. The signal shown on the display will disappear automatically after about 8 seconds.

10. Cleaning and storing the instrument

• Clean your blood pressure monitor carefully using a slightly damp cloth only.
• Do not use detergents or solvents.
• On no account must you immerse the computer in water, otherwise liquid can enter it and cause damage.
• When storing the device, make sure that no heavy objects are placed on top of it. Remove the batteries. The cuff tube should not have any sharp kinks.

11. Specifications

Model no. SBM 50

Type SBM 45

Measurement method Oscillometric, non-invasive blood pressure measurement on the upper arm

Measurement range Cuff pressure 0 – 300 mmHg, systolic 60–260 mmHg, diastolic 40–199 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 2 x 60 memory spaces

Dimensions L 100 mm x W 150 mm x H 58 mm

Weight Approx. 475 g (without batteries)

Cuff size 22 to 30 cm

Permissible operating conditions +5 °C to +40 °C, ≤90 % relative air humidity (non-condensing)

Permissible storage conditions	-20 °C to +55 °C, ≤95 % relative air humidity, 800 -1050 hPa ambient pressure
Power supply	4 x 1,5 V— — AA batteries
Battery life For approx.	500 measurements, depending on the blood pressure level and/or pump pressure
Accessories Instruction for use, 4 x 1.5 V AA batteries, storage pouch
Classification	Internal supply, IPX0, no AP or APG, continuous operation, type BF applied part

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

- This unit is in line with European Standard EN 60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Service address or found at the end of the instructions for use.

- This device is in line with the EU Medical Devices Directive 93/42/EC, the “Medizinproduktegesetz” (German Medical Devices Act) and the standards EN 1060-1 (non-

invasive sphygmomanometers, Part 1: General requirements), EN 1060-3 (non-invasive sphygmomanometers, Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC 80601-2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements for the safety and essential performance of automated non-invasive blood pressure monitors).

- 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.

12. Mains part

Model No. FW 7575M/EU/6/06

Input 100–240 V, 50–60 Hz

Output 6 V DC, 600 mA, only in connection

with Sanitas blood pressure monitor

Protection This device is double insulated andprotected against short circuit andoverload by a primary thermal fuse. Make sure to take the batteries out of the compartment before using the mains part.
	Double insulated /equipment class 2
	Polarity of the the DC voltage connection
Enclosures and Protective Covers	Equipment enclosed to protect against contact with live parts, and with parts which can become live (finger, pin, hook test). The operator shall not contact the patient and the output plug of AC mains part simultaneously.

FRANÇAIS

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

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

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

Pure technical line drawing of a mechanical component without any text, numbers, or symbols

Simple line drawing of a mechanical component with two upward arrows and a central base (no text or symbols)

4 x 1,5V AA (LR6)

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

Illustration of a person's leg with a medical device attached, showing no text or symbols

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

Pure technical line drawing of a mechanical component without any text, numbers, or symbols

Simple line drawing of a mechanical component with two upward arrows and a base (no text or symbols)

4 x 1,5V AA (LR6)

Illustration of a wristwatch with barometer and forearm (no text or symbols)

Illustration of a human leg with a medical device attached, showing body and leg positioning (no text or symbols)

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

Pure technical line drawing of a mechanical component without any text, numbers, or symbols

Table 1 For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture's declaration – electromagnetic emissions
The SBM 50 is intended for use in the electromagnetic environment specified below.The customer or the user of the SBM 50 should assure that it is used in such an environment.
Emissions test	Compliance	Electromagnetic environment – guidance
RF emissions CISPR 11	Group 1	The SBM 50 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class B	The SBM 50 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3	Complies

Table 2 For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer's declaration – electromagnetic immunity
The SBM 50 is intended for use in the electromagnetic environment specified below. The customer or the user of the SBM 50 should assure that it is used in such an environment.
IMMUNITY test	IEC 60601 test 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 floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burstIEC 61000-4-4	± 2 kV for power supply lines± 1 kV for input/output lines	± 2 kV for power supply lines M	Mains power quality should be that of a typical commercial or hospital environment.
SurgeIEC 61000-4-5	± 1 kV line(s) to line(s)± 2 kV line(s) to earth	± 1 kV line(s) to line(s)± 2 kV line(s) to earth	Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11	<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT (30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 s	<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT (30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 s	Mains power quality should be that of a typical commercial or hospital environment. If the user of the SBM 50 requires continued operation during power mains interruptions, it is recommended that the SBM 50 be powered from an uninterruptible power supply or a battery.
Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8	3 A/m 3 A/m		Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer's declaration – electromagnetic immunity
The SBM 50 is intended for use in the electromagnetic environment specified below. The customer or the user of the SBM 50 should assure that it is used in such an environment.
IMMUNITY test	IEC 60601 test level	Compliance level	Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6Radiated RF IEC 61000-4-3	3V_rms 150 kHz to80 MHz3V/m80 MHz to2.5 GHz	3V_rms 3V/m	Portable and mobile RF communications equipment should be used no closer to any part of the SBM 50, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance: d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz to 2.5 GHzWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, ^a should be less than the compliance level in each frequency range. ^b 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 SBM 50 is used exceeds the applicable RF compliance level above, the SBM 50 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SBM 50.
^b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the SBM 50
The SBM 50 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SBM 50 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SBM 50 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)
	150 kHz to 80 MHz d = 1.2	80 MHz to 800 MHz d = 1.2	800 MHz to 2.5 GHz d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100	12	12	23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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.