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Omron HEM-9210T, Instruction Manual

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Omron HEM-9210T Instruction Manual Download Page 39

39

Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipment type
HEM-9210T is in compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet
address: www.omron-healthcare.com

Summary of Contents for HEM-9210T

Page 1: ...INSTRUCTION MANUAL Automatic Upper Arm Blood Pressure Monitor Model HEM 9210T 2800028 0I Issue Date 2021 06 21 ENGLISH ...

Page 2: ...ion 4 1 Know Your Device 8 2 Preparation 12 3 Using the Device 15 4 Error Messages and Troubleshooting 22 5 Maintenance and Storage 27 6 Specifications 32 7 FCC IC RE Statement and Trademarks 38 8 Limited Warranty 40 9 Guidance and Manufacturer s Declaration 41 ...

Page 3: ...r own blood pressure CONSULT WITH YOUR PHYSICIAN Intended Use The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings Environment of Use Home Patient Population Adult ...

Page 4: ...m under medical treatment Stop using the device and consult your physician if you experience skin irritation or other troubles Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion Consult your physician before using the device on the arm with an arterio venous A V shunt Do not use the device with other medical electrical ME equipment simultaneously This may ...

Page 5: ...sage Keep the battery out of reach of children toddlers or infants Caution Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury to the user or patient or damage to the equipment or other property General Usage Always consult your physician Self diagnosis of measurement results and self treatment are dangerous Consult your physician before using th...

Page 6: ... cuff is applied Data Transmission Do not replace the battery or unplug the AC adapter when in use for wireless communications This may result in incorrect operation of the device or damage to the data Do not place integrated circuit cards magnets metal objects or other devices that emit electromagnetic fields near the device when in use for wireless communications This may result in incorrect ope...

Page 7: ...d your arm Do not use the device outside the specified environment It may cause an inaccurate reading Use only an AC adapter arm cuff batteries and etc specified for this device Use of unsupported adapters arm cuff and batteries may damage and or may be hazardous to the device Dispose of the device components and optional accessories according to applicable local regulations Unlawful disposal may ...

Page 8: ...attery set instruction manual quick start guide Monitor Arm cuff Arm circumference 22 42 cm 9 17 A Display B START STOP button C Battery compartment D Air jack E AC adapter jack for optional AC adapter C D E A B F H G F Arm cuff G Air plug H Air tube ...

Page 9: ...K symbol L Systolic blood pressure M Diastolic blood pressure N Battery symbol low depleted O Heartbeat symbol Flashes during measurement P Movement error symbol Q Irregular heartbeat symbol R Deflation symbol S Pulse display L M N L O K Q P R S I J ...

Page 10: ...ays with your measurement results we recommend you consult your physician Follow the directions of your physician Movement Error Symbol The movement error symbol is displayed if you move your body during the measurement Please remove the arm cuff and wait 2 3 minutes Take another measurement remain still during measurement SYNC Symbol The SYNC symbol is displayed if the device is not connected to ...

Page 11: ...nsmission range to successfully transfer data This Omron blood pressure monitor is designed to connect to specific Bluetooth receivers and is not guaranteed to connect to all Bluetooth compatible devices and Telehealth service receivers OMRON HEALTHCARE Co Ltd cannot accept liability for any damages incurred due to impaired operation or data loss etc that occur through the use of this product 1 3 ...

Page 12: ...d battery symbol appears on the display turn the monitor off and remove all the batteries Replace with 4 new batteries at the same time Long life alkaline batteries are recommended The measurement values continue to be stored in memory even after the batteries are replaced The supplied batteries may have a shorter life than new batteries Disposal of used batteries should be carried out in accordan...

Page 13: ...not appear refer to Connection failure Data is not being transmitted in section 4 2 To retry connecting the Telehealth service receiver remove batteries and press START STOP button for 2 3 times Then start with step 2 again Note If your Telehealth service receiver asks for a PIN code enter the digits of the PIN code located on the rating label at the bottom of the device XXXXXX PIN code XXXXXXXXXX...

Page 14: ... appears refer to Connection failure Data is not being transmitted in section 4 2 for more detail Notes We recommend keeping batteries in the device at all times even if you choose to use the AC adapter If only the AC adapter is used without keeping the batteries in the device the device connection process steps 4 and 5 is necessary each time you unplug and plug back the AC adapter ...

Page 15: ...15 3 Using the Device 3 1 Applying the Arm Cuff Remove tight fitting clothing from your left upper arm Do not place the arm cuff over thick clothing 1 Connect the air plug to the unit ...

Page 16: ...The bottom edge of the arm cuff should be 1 2 inch 1 to 2 cm above the elbow The air tube is on the inside of your arm and aligned with your middle finger Note Please refer to the operating instruction of the HEM RXL31 for applying the extra large cuff 1 2 cm 1 2 inch ...

Page 17: ...l not to rest your arm on the air tube The blood pressure can differ between the right arm and the left arm and the measured blood pressure values can be different Omron recommends to always use the same arm for measurement If the values between both arms differ substantially please check with your physician as to which arm to use for your measurements ...

Page 18: ... feet flat on the floor Sit with your back and arm being supported The arm cuff should be placed on your arm at the same level as your heart 3 3 Taking a Measurement Notes To stop the measurement press the START STOP button once to deflate the arm cuff Remain still and do not talk while taking a measurement The reading is stored in the memory and cannot be viewed on the display ...

Page 19: ... pressure is more than 210 mmHg After the arm cuff starts to inflate press and hold the START STOP button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure Notes The monitor will not inflate above 299 mmHg Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied ...

Page 20: ...to Connection failure Data is not being transmitted in section 4 2 for more detail 3 After data transfer is completed press the START STOP button to turn the monitor off It will automatically turn off after 2 minutes Note Wait 2 3 minutes before taking another measurement Waiting between measurements allows the arteries to return to their prior condition to taking a measurement ...

Page 21: ...iagnose and treat high blood pressure Always consult your physician Self diagnosis of measurement results and self treatment are dangerous Read What to do if your systolic pressure is more than 210 mmHg of this instruction manual if your systolic pressure is known to be more than 210 mmHg Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied ...

Page 22: ...ontinues to appear contact your physician Movement during measurement Carefully read and repeat the steps in section 3 3 Connection failure Data is not being transmitted Refer to Connection failure Data is not being transmitted in section 4 2 The batteries are low Recommend to replace 4 batteries with new ones at this time Refer to chapter 2 The batteries are depleted Immediately replace the 4 bat...

Page 23: ...tion 5 3 Movement during measurement and the arm cuff has not been inflated sufficiently Repeat measurement Remain still and do not talk during measurement Refer to section 3 3 If E2 appears repeatedly inflate the arm cuff manually until it is 30 to 40 mmHg above your previous measurement result Refer to section 3 3 The arm cuff was inflated exceeding the maximum allowable pressure and then deflat...

Page 24: ... any clothing interfering with the arm cuff Refer to section 3 1 The cuff may not be the correct size for your arm Measure your arm circumference to make sure that you are using the correct size cuff Refer to section 5 3 Communication failed Refer to Connection failure Data is not being transmitted in section 4 2 Device error Contact your Telehealth service provider Error Display Cause Solution ...

Page 25: ...oblem Cause and Solution No power No display appears on the monitor Replace all batteries with new ones Check the battery installation for proper placement of the battery polarities Refer to chapter 2 Measurement values appear too high or too low Blood pressure varies constantly Many factors including stress time of day and how you wrap the cuff may affect your blood pressure Review the section 1 ...

Page 26: ...is turned off Turn on the Bluetooth feature on the receiver To retry connecting the Telehealth service receiver remove batteries and press START STOP button for 2 3 times Then reinstall batteries The blood pressure monitor did not pair successfully to the receiver Try to pair the devices again Refer to chapter 2 The application on the receiver or destination device is not ready Check the applicati...

Page 27: ...e and the components in a clean safe location Do not use any abrasive or volatile cleaners Do not wash the device and any components or immerse them in water Do not use gasoline thinners or similar solvents to clean the device Use a soft dry cloth or a soft cloth moistened with neutral soap to clean on the monitor and the arm cuff ...

Page 28: ...he air plug from the air jack 2 Gently fold the air tube into the arm cuff Note Do not bend or crease the air tube excessively Do not store the device in the following situations If the device is wet Locations exposed to extreme temperatures humidity direct sunlight dust or corrosive vapors such as bleach Locations exposed to vibrations shocks or where it will be at an angle ...

Page 29: ...struction of the HEM RXL31 for applying the extra large cuff Arm cuff Arm circumference 42 50 cm 17 20 Arm circumference 22 42 cm 9 17 Arm circumference 17 22 cm 7 9 Extra Large Cuff Wide Range Cuff Same as the arm cuff provided with the product Small Cuff AC Adapter ...

Page 30: ... 42 50 cm 17 20 HEM RXL31 North America Asia Wide Range Cuff 22 42 cm 9 17 CD WR17 North America HEM RML31 Asia Small Cuff 17 22 cm 7 9 CD CS9 North America HEM CS24 Asia AC Adapter HEM ADPTW5 North America HHP CM01 Asia HHP OH01 Australia and New Zealand HHP BH01 India Omron representative in North America Omron representative in Asia Call 1 800 634 4350 Visit OmronHealthcare com Visit www omronh...

Page 31: ...nect and disconnect the AC adapter 1 Insert the AC adapter plug into the AC adapter jack on the rear side of the monitor 2 Plug the AC adapter into an electrical outlet To disconnect the AC adapter unplug the AC adapter from the electrical outlet first and then remove the AC adapter plug from the monitor ...

Page 32: ...ower 20 dBm Operation mode Continuous operation IP classification Monitor IP20 Optional AC adapter HEM ADPTW5 HHP CM01 IP21 HHP OH01 HHP BH01 IP22 Rating DC6 V 4 W Power source 4 AA batteries 1 5V or optional AC adapter INPUT AC100 240V 50 60Hz 0 12 0 065A Battery life Approximately 1000 measurements using new alkaline batteries Durable period Service life Monitor 5 years Cuff 1 year Optional AC a...

Page 33: ...f 12 mm diameter and greater such as a finger The AC adapters HEM ADPTW5 HHP CM01 are protected against vertically falling water drops which may cause issues during a normal operation Other AC adapters HHP OH01 and HHP BH01 are protected against oblique falling water drops which may cause issues during a normal operation Dimensions Monitor Approximately 107 w mm 79 h mm 141 l mm 4 1 4 3 1 8 5 1 2 ...

Page 34: ...ch is the Pressure Sensor is produced in Japan Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device Symbols description Consult instructions for use Refer to instruction manual Applied part Type BF Degree of protection against electric shock leakage current Class II equ...

Page 35: ... cuffs compatible for the device Cuff positioning indicator for the left arm Artery mark Range pointer and brachial artery alignment position Range indicator of arm circumferences to help selection of the correct cuff size Manufacturer Authorized representative in the European Community Symbols description or or ...

Page 36: ...ower supply unit Medical device Date of manufacture About a wireless communication interference This product operates in an unlicensed ISM band at 2 4 GHz In the event this product is used near other wireless devices such as microwave and wireless LAN which operate on the same frequency band as this product there is a possibility that interference may occur If interference occurs stop the operatio...

Page 37: ...please separate this product from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources Household users should contact either the retailer where they purchased this product or their local government office for details of where and how they can return this item for environmentally safe recycling Business users should contact their supplier and check...

Page 38: ...ipment off and on the user is 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 This trans...

Page 39: ...ARE Co Ltd declares that the radio equipment type HEM 9210T is in compliance with Directive 2014 53 EU The full text of the EU declaration of conformity is available at the following internet address www omron healthcare com ...

Page 40: ... WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW IF ANY ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL INCIDENTAL C...

Page 41: ...d result in improper operation During measurement the use of the device adjacent to or stacked with other device should be avoided because it could result in improper operation In case such use is necessary the device and other device should be observed to verify that they are operating normally During measurement Portable RF communications device including peripherals such as antenna cables and e...

Page 42: ...ges Line to line IEC 61000 4 5 0 5kV 1 kV for Input a c power port Conducted disturbances induced by RF fields IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM and amateur radio bands between 150 kHz and 80 MHz 80 AM at 1 kHz for Input a c power port Rated power frequency magnetic fields IEC 61000 4 8 30 A m 50 Hz and 60Hz for enclosure port Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 9...

Page 43: ...iation 1 kHz sine 2 0 3 28 710 704 to 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 to 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 to 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 to 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modul...

Page 44: ...INC 2895 Greenspoint Pkwy Hoffman Estates IL 60169 USA OmronHealthcare com Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE LTD www omronhealthcare ap com OMRON HEALTHCARE EUROPE B V Scorpius 33 2132 LR Hoofddorp THE NETHERLANDS www omron healthcare com Importer in EU 2021 OmronHealthcare Inc Made in Japan ...

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