Shenzhen 121 Aram Blood Pressure Monitor User Manual

June 15, 2024
Shenzhen

Shenzhen 121 Aram Blood Pressure Monitor User Manual
Shenzhen 121 Aram Blood Pressure Monitor

INSTRUCTION AND INTENDED USE

The 121 is a fully automatic digital blood pressure monitor for measuring blood pressure and pulse rate in adults at home or in medical facilties.

Itis designed for use on the upper arm with arm circumferences ranging from 22-42cm. The oscillometric technology enables quick and reliable measurement of systolic pressure, diastolic pressure, and pulse rate.

The 121 can detect irregular heart rhythms during measurement. It provides dinically accurate results in a user-friendly device.

This monitor is intended for adult users to measure their own blood pressure and pulse rate. The user can safely operate monitoring functions, clean the device, and replace batteries.

Please read these instructions thoroughly prior to use and keep them for reference. Consult your physician if you have any questions regarding blood pressure measurement.

CONTRAINDICATIONS:

Do not use this blood pressure monitor on patients undergoing dialysis therapy or taking anticoagulants, antiplatelet agents, or steroids, as this could lead to internal bleeding.

INTENDED PATIENT POPULATION:

‘This blood pressure monitor is only intended for use on adult patients. Consult with a physician before using this device on children.

INTENDED CUFF PLACEMENT:

Place the cuff on your bare upper arm, one inch above the elbow bend. Position the cuff so the tubing falls over the front center of your arm, ensuring the sensor aligns correctly. Pull the end of the cuff evenly to ensure it is snug but not too tight.

WARNINGS :

  • The patient is considered the operator when using this device bindependently.
  • Do not service or maintain this device while it is in use.
  • Al functions can be safely used by the patient.
  • The patient can perform maintenance like changing batteries and cleaning. = DO NOT use this monitor on infants, toddlers, children or persons unable t0 express themselves.
  • DO NOT use on injured arms or arms undergoing medical treatment.
  • DO NOT apply arm cuff over intravenous drips or blood transfusions.
  • Do NOT use this blood pressure monitor near high frequency (HF) surgical ‘equipment, magnetic resonance imaging (MRI) equipment, or computerized tomography (CT) scanners.

These environments may interfere with the monitor’s operation and cause inaccurate readings.

  • Consult your physician before using this device if you have arrhythmias, arterial sclerosis, poor perfusion, diabetes, pregnancy, preeclampsia, renal disease or other conditions that could affect measurement accuracy due to motion, trembling or shivering.
  • NEVER diagnose or treat yourself based only on your readings. ALWAYS consult your  physician.
  • Small parts may pose a choking hazard for infants, toddlers and children.
  • Stop use and consult your physician if skin iritation or discomfort occurs.
  • Consult your physician before use on wrists with vascular access, shunts or grafts, which could impact blood flow.
  • Consult your physician before use if you have had a mastectomy.
  • Consult your physician if you have severe blood flow problems or disorders, as cuff infiation can cause bruising.
  • Take measurements only as needed, as blood flow interference may cause bruising.
  • ONLY inflate the arm cuff when applied on your arm.
  • Remove the cuff If it does not start defiating during measurement.
  • Use this device ONLY for measuring blood pressure.
  • Keep electronic devices at least 12 inches away during measurement, as they may interfere with accuracy.
  • DO NOT disassemble o attempt to repair this blood pressure monitor or  any components. Doing so may cause inaccurate readings.
  • DO NOT use where exposed to moisture or water splashes. This may damage the monitor.
  • DO NOT use in moving vehicles.
  • DO NOT drop or subject the monitor to shocks or vibrations.
  • Only use within specified temperature and humidity ranges.
  • Check that cuff is not impairing circulation during measurement.
  • DO NOT use in high traffic medical settings.
  • DO NOT use simultaneously with other medical electrical equipment.
  • This may affect readings.
  • Avoid stimulants, exercise, and eating for 30 minutes before measurement.
  • Rest 5 minutes before taking a measurement.
  • Remove tight clothing and accessories from wrist during measurement.
  • Remain still and silent while measuring.
  • ONLY use monitor on wrists within specified cuff size range.
  • Allow the monitor to acclimate to room temperature for at least 2 hours before use f It has been exposed to extreme temperature changes, Taking a measurement too soon can lead to inaccurate resuits. This bration time is recommended when the monitor is used within the specified operating temperature range, after being + Do NOT bend or crease the arm cuff excessively.
  • Do NOT use past indicated durable period.
  • Never apply cuff over wounds as it may cause further injury.
  • Do NOT modify this device without manufacturer authorization.
  • If modifications are made, appropriate Inspection and testing must be conducted to ensure safety.
  • Allow [specified time] before use for the device to warm from the minimum storage temperature to 20°C ambient.
  • Allow [specified time] before use for the device to cool from the maximum storage temperature to 20°C ambient.

Warning :

  • Use of power adapters
  • Adapter: input 100-240v, 50/60hz output DC 5V 1A
  • Do not to pasition the device to make it difficult to operate the disconnection device while using adaptor.
  • Only use the cuffs, adapters and batteries included or replacements from the manufacturer.
  • Avoid water, high heat, sunlight or corrosive gas exposure which can damage components.
  • Remove batteries if not using for a prolonged period. Do not use batteries and adapter at the same time.
  • The AC adapter has not been evaluated per safety standards when connected to a separate USB Interface.
  • Do not bend or kink tubing during use as this can restrict blood flow.
  • Avoid compressing or restricting the connection tubing.
  • Stop use and contact the distributor or manufacturer if performance changes.
  • Only use approved accesseries and parts.
  • When display’ 1″ . please replace batteries immediately.
  • Batteries support approximately 10 measurements.
  • Allow 2 hours for the monitor to adjust to room temperature before use if it was stored in very hot or cold temperatures. This helps provide accurate readings.
  • Keep the monitor away from strong electrical or electromagnetic fields. (like cell phones and microwaves) during use. These can interfere with results.
  • Do not try to repair the device yourself f issues occur. Contact the manufacturer or local distributor for 0service support.
  • This device can interfere with other electrical medical equipment during certain treatments.

Note: For best results, use this monitor in the specified temperature and humidity ranges. Check the user manual for the details. The right conditions prevent incorrect readings. Just a minute to confirm the temperature and humidity can make readings more reliable. Accurate readings help you monitor health over time.

Note: The cuff touches your arm when in use. It is made of latex-free materials. If help is needed with setup, usage, or maintenance, please contact our support team.We are ready to assist you with any questions about the monitor and cuff. Reach out anytime.

Attention: Tracking your health data is helpful for discussions with your doctor. Do not diagnose or treat yourself based on these readings. Always consult your physician if any values seem abnormal. Never change medication dosages without medical advice. Also note this device cannot accurately measure pacemaker heart rates. For any concerns, contact your healthcare provider.

Note: For Accurate Readings, use this monitor in the temperature and humidity ranges listed in the user manual. Checking the Technical Specifications ensures correct conditions. The right environment helps get precise blood pressure values. Just taking a minute to confirm the temperature and humidity can improve reliability. Accurate readings allow better health tracking over time. Please contact us if any questions arise while using this device.

Note: The cuff has direct contact with your arm. If help is needed with setup, usage, or maintenance, please reach out to us.
Our support team s ready to assist with any questions about the monitor and cuff. We want to ensure this device works smoothly for you

IMPORTANT INFORMATION ON BLOOD PRESSURE AND ITS MEASUREMENT

What Causes High or Low Blood Pressure?

Your brain’s circulation center regulates blood pressure. It adjusts to different situations through the nervous system feedback. To shift blood pressure, the heart rate strength and speed change. Blood vessel width also varies as fine muscles in vessel walls contract or relax.

Pressure rises and falls in cycles with your heartbeat. It peaks when the heart contracts to pump blood out (systolic pressure). It dips when the heart relaxes between beats (diastolic pressure).

Normal ranges exist to prevent health issues. High or low values may. signal problems. Monitoring at home  aids diagnosis and guides treatment.

Discuss your results with your doctor. Together you can understand causes and find solutions to optimize your blood pressure.

WHICH VALUES ARE NORMAL

Please refer to the diagram below(Picture-01)
WHICH VALUES

The monitor screen shows six blood pressure levels. Check picture 01-01 in the user manual for the key.

Blood pressure value WHO grids in device WHO Classification
DIA<80 & SYS<120 1 Optimal blood pressure
DIA <85 & SYS<130 2 Optimal blood pressure
DIA<90 & SYS<140 3 High normal value
DIA<100 & SYS <160 4 Mild hypertension
DIA<110 & SYS<180 5 Moderate hypertension
DIA>=110 or SYS>=180 6 Severe hypertension

Contact your doctor right away if your blood pressure is 0/160 mmHg or higher when resting.

These levels indicate dangerously high blood pressure. Prolonged high values severely damage blood vessels, posing serious health risks. Work closely with your physician to lower your blood pressure into a healthy range.

Lifestyle changes and medications can help control high blood pressure before complications develop.

Consult your doctor if systolic readings range 140-159 mmHg or diastolic 90~ 99 mmHg. Regular self-checks are important with these borderline high values.

Contact your physician also if systolic dips under 90 mmHg or diastolic under 60 mmHg, as this indicates low blood pressure.

Even with normal results, consistently self-monitoring with this easy device s recommended. You can spot changes early and take appropriate action.

1f managing blood pressure medically, keep detalled records of results, times and dates. Review with your doctor – never adjust medications without quidance.

Calibrating Your Blood Pressure Monitor

Follow these steps to verify calibration:

Step 1. From time mode, press and hold the settings key, then press memory to enter pressure test mode.

Step 2. Connect the special plug to tubing attached to a pressure source and gauge. Insert into the arm cuff port.

Step 3. The monitor now shows the static pressure reading. Compare this value to the gauge.

If the difference is less than 3 mmHg, the device is properly calibrated.

Further information

  • Contact your physician if values are normal at rest but spike under stress.
    This  signals potentially unstable or “labile” hypertension.

  • Diastol Diastolic readings . consistently y over 120 mmHg require urgent s usys Sy E B medical care.

What Should You Do If Blood Pressure Readings Are o+~ ” =dif X Regularly Too High or Too Low?

  1. Consult your doctor. 98788 [ B @& d
  2. Over time, increased blood pressure values (various forms of T T ? hypertension) are associated with considerable health risks. High blood ’ I cT pressure can lead to arteriosclerosis, which is hardening of the arterial blood vessel walls. Arteriosclerosis can result n Inadequate blood supply tovital organs like the heart, brain, and muscles.

Components of Your Blood Pressure Monitor

Blood Pressure Monitor
Blood Pressure Monitor

Led Display

The symbols on the Picture-05

  1. Blood pressure monitor indicator
  2. Battery symbol
  3. Mute symbol
  4. Date/Time display
  5. Memory symbol
  6. Average value symbol
  7. USER symbol
  8. Heartbeat symbol
  9. Systolic blood pressure
  10. Diastolic blood pressure
  11. Pulse display
  12. Number of group symbol
  13. Irregular heartbeat symbol
  14. Systolic
  15. Diastolic

First Use of Your Blood Pressure Monitor

Activate the pre-installed batteries before first use.

Battery Installation Use only 1.5V alkaline AAA batteries in this device.

To install batteries:

  1. Press the hook on the battery cover and lift off in the direction of the
    amow.

  2. Insert 4 AAA batteries matching + and – to the polarities in the
    compartment. Replace the cover securely. When the low battery indicator appears

  3. Tum off and remove all batteries. Replace all 4 with new alkaline batteries at once.

  4. Remove batteries if unused for over 3 months to prevent damage from leakage. Rinse eyes immediately with water if fluid gets in eyes. See a doctor right away.

  5. The attached battery is for testing only. Use alkaline batteries for regular monitoring.

  6. Dispose of device, parts, and accessaries according to local regulations. Improper disposal can cause pollution.

  7. Batteries are hazardous waste. Do not mix with other rubbish.

System Settings

After loading batteries or connecting power:

Press and hold the SET button for over 5 seconds until flashing numbers ‘appear to start setup.

Note: Hold the button while powered off instead of turning on the screen first.

ASetting the User:

Press A or B to switch between user A and B. The screen displays the selected user.

B.Setting the Year:

With device off, press and hold SET for over 5 seconds until YEAR flashes.

Press MEM continuously to increase the year to 2099, Press SET to confirm the year.

C.Setting the Month/Date:

After setting the year, MONTH/DATE flashes. Press MEM to increase the month by

  1. Press SET to confirm. Follow the same steps to set the date.

Press SET to confirm.

D.Setting the Time:

After setting the month/date, TIME flashes. Press MEM to increase the hour by

  1. Press SET to confirm. Follow the same steps to set the minutes.

Press SET to confirm.

E.Setting the Speaker:

After setting the time, SP flashes. Press MEM to turn the speaker on or off. Press SET to confirm.

F.Setting the Unit:

The default unit is mmHg. After speaker setup, PA flashes. Press MEM to turn PA on and change the unit to kPa.

G. Record Delete:

To delete memories:

With machine off, press and hold MEM for 3 seconds. While still holding MEM, press and hold SET for 3 sec all memories have been deleted.

Note:

Deleting records erases all measurements at once. Before deleting, save needed records another way. Removing batteries does not erase records.

Measurement Procedure

Note: Always sit and stay calm before and during measurement.

Before measurement

  • Avoid eating, smoking, and exertion before measuring, as these influence results. Sit quietly for 10 minutes before measuring.
  • Remove any tight clothing from the upper arm.
  • Always measure the same arm, usually left.
  • Compare measurements taken at the same time of day, as blood pressure varies up to 20-40 mmHg during the day.

Common sources of error:

Note: For comparable blood pressure measurements, maintain the same conditions.

  • Always maintain quiet conditions.
  • Avoid muscle flexing in the arm being measured, as this can increase blood pressure. Use a relaxed, comfortable posture with arm support if needed.
  • If the arm is much higher or lower than heart level, measurement error Up to 10 mmHg per 25-30 cm height difference may occur.
  • Incorrect cuff size causes inaccurate readings. Match cuff to arm circumference as marked on cuff.
  • Cuff pressure range is 0-300 mmHg.
  • Wide range rigid cuff fits arm circumferences of 22-32 cm.

Note:

  • Only use approved cuffs.
  • Loose or misaligned cuffs cause inaccurate readings.
  • Consecutive measurements can accumulate blood in the arm and affect results. Wait 1 minute between measurements or raise am to allow blood flow before remeasuring.

Fitting the Cuff

Please refer to picture-06.
Fitting the Cuff

Applying the cuff:

  • a) Remove tight clothing from upper arm.
  • b) Wrap cuff around upper left arm with tube inside the arm extending downwards. Position cuff 1-2 cm above elbow. Important: Align artery mark on cuff edge over artery on inner arm.
  • c) Wrap and secure cuff with closure.
  • d) Leave space for 2 fingers between arm and cuff. Improper fit causes inaccurate readings. If unsure of proper fit, measure arm circumference.
  • e) Rest arm on table with palm up, keeping cuff at heart level. Ensure tube s not kinked.
    f) Sit quietly for 2 minutes before measuring.

Measure Procedure

Refer to picture-07

Taking a measurement:

  1. Sit comfortably with feet flat on floor.
  2. Select user ID A or 8.

Extend am forward on desk, palm up. Keep arm relaxed and still. Avoid moving or talking during measurement. Once cuff is positioned on arm properly:

  • a) Press START/STOP. Pump infiates cuff. Display shows increasing pressure.
  • b) Pump stops at individual pressure, then pressure slowly decreases. Display shows cuff pressure.
  • c) When pulse Is detected, heart symbol blinks.
  • d) When finished, display shows systolic and diastolic pressure and pulse rate.
  • e) Irreqular heartbeat symbol may appear, but stay relaxed and sl during measurement.
  • f) Results display until power off. Auto-off after 60 seconds idle.

NOTE:

Patient Position:

  1. Sit comfortably
  2. Legs uncrossed
  3. Feet flat on floor
  4. Back and arm supported
  5. Cuff at heart level

Recommended Use Methods

  1. Patient should relax and not talk during measurement.
  2. Wait § minutes before first reading.
  3. Readings can be affected by measurement site, patient position, exercise, or condition.
  4. Extremes of temperature, humidity and altitude can affect performance.
  5.  Press START/STOP to stop inflation or measurement.
  6. Cuff automatically deflates after detecting blood pressure and pulse. Displays readings.
  7. Automatically turns off after 1 minute.
    Displays readings.

Irregular Heartbeat Detector

  • This symbol indicates irregular pulse detected during measurement.
  • Result may deviate from normal blood pressure – repeat measurement.
  • If symbol appears frequently (e.g. several times per week or suddenly more often than usual), consult your doctor.
  • Device analyzes pulse and displays irregular heartbeat symbol if irregularities occur during measurement.
  • Instrument does not replace cardiac exam but helps detect puiseirreqularities early.

Error Indicates

Abnormal Measurement Symbols

SYMBOL CAUSE CORRECTION
Er 1 Sensor abnormal
  1. Remain still and quiet before measuring.
  2. Check that pump is working properly.

Er 2| Blood pressure can’t be measured| Check cuff position and remeasure using proper posture.
Er 3| Blood pressure is abnormal| Check cuff position and remeasure with proper posture.
Er 4| Blood pressure arm cuff cannot be pressurized|

  1. Check air path is not blocked.
  2. Check arm cuff Is not too loose.

Er 5| Arm cuff is pressurized too fast|

  1. Check for blockage in air path.
  2. Check if arm cuff is too tight.

Erb| Excessive pressure interference| Use proper posture when measuring. Remain still during measurement.
Er 7| The pressure exceeds the limit| Use proper posture when measuring. Remain still during measurement.

Trouble Removal

PROBLEM CHECK CAUSE AND SOLUTION
No power Check the battery power Replace new one
Check the polarity position Installation for proper placement of the

batteries polarities
Inset into the air socket tightlyz| Whether the plug insert| Inset into the air socket tightly
Whether the plug insert| Change a new cuff
Err and stop working| Whether move the arm when inflate| Keep the body peaceful
Check if chatting when measured| Keep quite when measure
Cuff leak| Whether the cuff wrap too loose| Wrap the cuff tightly
loose| Change a new cuff
If problem persists, contact distributor. Do not disassemble unit yourself.

SYMBOL DESCRIPTIONS

The fallowing symbols may appear in this manual, on the monitor, or accessories. Some symbols represent standards and compliance for the Ere |excessive pressure® | e proper posture when measuring. monitor and s use:

  • Authorized Representative in the European Community
  • CE Mark: conforms to essential requirements of the Medical Device Regulation 2017/745
  • Date of manufacture
  • Manufacturer
  • Specifies serial number
  • Direct current
  • DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
  • Follow instructions for use
  • Put up
  • Fragile
  • Keep dry
  • Avoid the sun
  • Temperature range
  • Follow instuction for use
  • Type BF Applied Part
  • **** Indicates separate collection for waste of electrical and electro-nic equipment(WEEE)
  • Use-by date, indicating the date after which the device is not to be use(i.e; the expiration date)
  • IP22: Degrees of protection provided by enclosure

Memory

At the end of a measurement, this monitor automatically stores each result with date and time. Each unit stores 99 sets measurements for 2 users, totally 198 sets (User A and 8)

Viewing the stored values

With the unit off, press the Memory button. The display first shows “A”, then shows an average of all measurements stored in the unit. Please note: Measurements for each user are averaged and stored separately. Be certain that you are viewing the measurements for the correct user. Pressing the Memory button again displays the previous value. To view a particular stored memory, press and hold the Memory button to scroll to that stored reading.

Discontinuing a Measurement

If it is necessary to interrupt a blood pressure measurement for any reason (2.q the patient feels unwell), the Start/Stop button can be pressed atany time. The device then immediately lowers the cuff pressure automatically.

Battery Change Indicator

Replace batteries – low battery

When batteries are low, the battery symbol will flash when turning on the device. No measurements can be taken until batteries are replaced.

Replacing Batteries

  • a)The battery compartment is on the back of the unit.
  • b)Remove the cover as shown in picture-08.
  • c)Insert 4 AAA batteries. Use alkaline or long life batteries.
  • d)The memory retains readings after battery change, but date and time must be reset. The year number wil flash after battery replacement.
  • e)Ta set date and time, follow the steps in Section 4.2
    Replacing Batteries

What batteries to use an

d how to replace them?

Use 4 new AAA 1.5V longlife batteries. Do not use expired batteries. Remove batteries if not using the monitor for a prolonged period.

Using rechargeable batteries

You can also operate this instrument using rechargeable batteries.

  • Only use “NIMH” reusable batteries!
  • If the battery symbol the batteries must be removed and recharged! They must not remain inside the instrument, as they may become damaged through total discharge even when switched off. The batteries must NOT be discharged in the blood pressure monitor! If you do not intend to use the Instrument for a week or more, always remove the rechargeable batteries!
  • Recharge these batteries using an external charger and follow manufacturer’s instructions carefully.

Using the AC Adapter

Using AC Adapter

  • a)Use only the approved 5V DC/1A Type-C AC adapter to avoid damage
  • b)Ensure adapter and cable are not damaged.
  • c)Plug the cable into the adapter port on the right side.
  • d)Plug the adapter into the outlet. No battery power is used when connected.

Note:

  • No battery power is used when the AC adapter is connected.
  •  If power i interrupted, reset by unplugging and replugging the AC adapter.

Care and Maintenance

Wash hands after each use. If shared, wash before and after each use.

  • a)Avoid extreme temperatures, humidity, dust, and direct sunlight.
  • b)Handle the cuff gently. Avoid twisting or buckling.
  • c)Clean with a soft, dry clath. Do not use solvents.
  • d)Clean cuff spots gently with soapy damp cloth. Do not submerge cuff in water.
  • e)Handle tubing with care. Prevent kinking and keep away from sharp edges.
  • f)Avoid dropping or vibrating the monitor. Do not open the monitor. This Voids the warranty.
  • g)Dispose of batteries and electronics according to local regulations.

Accuracy Test

Sensitive measurement devices should be checked for accuracy periodically.
We recommend having an authorized dealer inspect this unit every 1 year.
Please contact your local distributor or the manufacturer.

Warranty

This blood pressure monitor has a 1 year warranty against manufacturer defects for the original purchaser from the purchase date. The warranty does not apply to damage from improper handling, accidents, professional.

‘The 1 year warranty only covers the blood pressure monitor itself. Accessories like the cuff are warranted for 1 year. The USB cable is excuded.

Internal parts are not user serviceable. Battery issues are not covered.

Note: Per international standards, the monitor should be checked annually for accuracy.

Certifications

Device standard:

‘This device is manufactured to meet the European blood pressure monitors:

EN [SO 81060-1 :2007 « IEC 80601-2-30 IEC60601-1-11 » IEC60601-1

Electromagnetic compatibility:

Device fulfills the stipulations of the International standard IEC60601-1-2

Technical Specifications

  • Model: 121 ‘Weight: 270g (Batteries and AC adapter are not included)
  • LED Digital Display Size : 76 (W) x 62 (L) x 2.8 (H) mm [ 3 (W)x2.44″(1)x0.11″(H)]
  • Accessories: 1xMain Device, 1xCuff, 1xUsers manual, 1xWarranty card ‘Operating Conditions:
  • Temperature: 5 to 40C;Humidity: 15% to 93% RH; ‘Storage And Shipping Condition: 25C to 70C;
  • Humidity: s 93% RH;
  • Operating Pressure Range : 70-106 kPa
  • Measurement Method : Oscillometric
  • Sensor: Resistive pressure sensor
  • Measurement Range: 0-280 mmHg
  • Blood Pressure Range : Systolic 55-255 mmHg, Diastolic 25-200 mmHg
  • Puise Rate Range: 40 – 199 bpm
  • Cuff Pressure Display: <300 mmHg
  • Memory: Stores last 99 measurements for 2 users (198 total)
  • Resolution: 1 mmHg
  • Accuracy: +3 mmHg pressure, £5% pulse reading
  • Power Supply: 4 x 1.5V AAA batteries or AC 100-240V 50/60Hz adapter
  • Accessories: Wide cuff fits 22-42 cm arms.
  • Auto Power Off: After 60 seconds of inactivity
  • Intended User: Adult
  • Expected Service Life: 5 years
  • Complies with ISO 81060-2: 2013

EMC Precautions

  1. Install and operate this product according to the provided EMC information. Portable and mobile RF devices may affect operation.
  2. Keep mobile phones and cther electromagnetic field emitting devices away to avoid incorrect operation.
  3. Caution: This unit has been thoroughly tested to ensure proper performance.
  4. Caution: Do not place this device adjacent to or stacked with other equipment. If unavoidable, observe normal operation when configured this way.

Guidance and Manufacturor’s Declaration – Electromagnetic Immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of device 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| 8 kV contact 2 kV, 4 kV, ± 8 kV, 15 kV air| 8 kV contact1 2 kV, 4 kV, e 8kV, 15 kV air| Floors should be wood, concrete orceramic tile. If floors are covered withsynthetic material, the relative humidityshould be at least 30 %.
Electrostatic transient / burstEEC 61000-4-4| + 2 kV for power supply lines
1 kV for input /output lines| Not
applicable| Mains power qualityshould be that of a typical commercialor hospital environment.
SurgeIEC 61000-4-5| IlkV line(s) to line(s)±2kV line(s) to earth| Not
applicable| Mains power quality should be that of a typical commercial or hospital environment.
Guidance and manufacturer’s declaration—electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Immunity
test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Conducted RFIEC61000-4-6| 3 Vrms150 kHz to 80 MHz3 V RMS outside the ISM band, 6 V RMSin the ISM and amateur bands 80% AM at IkHz| | Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=0.35Vpd=1.2Vp
Radiated RFIEC61000-4-3| 10 V/m80 MHz to 2.7 GHz 80% AM at 1kHz| 10 V/m80 MHz to 2.7 GHz 80% AM at 1kHz| 80MHz to 800MHz: d=1.2Vp 800MHzto 2.7GHz: d=2.3Vp Where, Pis the maximum output power rating of theptransmitter in watts (W) according to the transmittermanufacture– and d is the recommended separation distance.Om))IField strengths from fixed RF transmitters, as determined
Test frequenc y (MHz)| Band (MHz)| Service (MHz)| Modulation| Maximum
power(w)| Distance (m)| IMMUNITY TEST|
---|---|---|---|---|---|---|---
385| 380-390| TETRA 400| PulseModulation18 Hz| 1.8| 0.3| 27|
|
450| 430-470| GMRS 460, FRS 460| FMe5kHz deviation1kHz sine| 2| 0.3| 28|
710| 704-787| LTE Band13, 17| PulseModulatio n217 Hz| 0.2| 0.3| 9|
745|
780|
810| 800-960| GSM800/900,TETRA 800, OEN 820, CDMA 850,LTE Band 5| PulseModulatlo n18 Hz| 2| 0.3| 28|
870|
930
|
1720| 1700-19| GSM 1800;CDMA 1900; GSM 1900;DES.LTE Band 1,34,25; UMTS| | 2| 0.3| 28|
PulseModulatio n217 Hz|
1845|
1970|
2450| 2400-257090| Bluetooth, WLAN802.11 b/g/n ,RFID 2450,
LTE Band 7| PulseModulate n217 Hz| 2| 0.3| 28|

by an electromagnetic site survey, should be less than the compliance level in each frequency range.  Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones  andland mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.

B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Guidance and manufacture’s declaration – electromagnetic emission

The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should assure that it is used in such an environment.

Ratedmaximum output power of transmitter (W)| Separation distance according to frequency of transmitter (m)
---|---
150 KHz to 80 MHz d = 1,21,T)| 80 MHz to 800 MHz d = 1,2ff)| 800 MHz to 2.7 GHz d = 2,3fi
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 metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Guidance and manufacture’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment.

Ratedmaximum output power of transmitter (W)| Separation distance according to frequency of transmitter (m)
---|---
150 KHz to 80 MHz d = 1,21,T)| 80 MHz to 800 MHz d = 1,2ff)| 800 MHz to 2.7 GHz d = 2,3fi
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

Recommended separation distances between portable and mobile RF communications equipment and the device.

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

5240 5100-5800 ELAN 802.11 a/n Pulse Modulation 217 Hz 0.2 0.3 9

5500
5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting
antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

  • a) For some services, only the uplink frequencies are included.
  • b) The carrier shall be modulated using a 50% duty cycle square wave signal.
  • c) As an alternative to FM modulation. 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

The MANUFACTURER should consider reducing the minimum separation distance, based on RISK

MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher

IMMUNITY TEST LEVELS

shall be
calculated using the following equation: 6
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the

IMMUNITY TEST LEVEL in V/m.

Warranty Card

The First Repair Faults Reasons What is Repaired

Date:``Repaired by:
The Second Repair| Faults| Reasons| What is Repaired
Date:``Repaired by:

High Blood Pressure

  • If diastolic pressure is above 90 mmHg or systolic pressure is over 160 mmHg at rest, consult your doctor immediately. Sustained high blood pressure can damage blood vessels.
  • If systolic pressure is 140-159 mmHg or diastolic is 90-99 mmHg, see your doctor. Regular monitoring is needed.

Low Blood Pressure

  • If systolic pressure is under 90 mmHg or diastolic is under 60 mmHg, consult your doctor.
  • Even with normal readings, regularly check blood pressure to detect changes early.
  • If taking medication, record values with time/date and share with your doctor. Do not adjust medication dose on your own.

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