Omron HBP-1300 User's Manual
Contents
1. If using an antiseptic solution for cleaning follow the instructions of the manufacturer Accessory Care Non Invasive Blood Pressure Measurement NIBP Cuff Wipe clean on the surface of the cuff with a cloth moistened with a 70 v v dilution of isopropyl alcohol or a 76 9 to 81 4 v v dilution of disinfection ethanol ethyl alcohol Do not allow any liquids inside the cuff If a liquid gets in the cuff dry the inside well 24 Check before Use Before conducting safety checks be sure to implement the items in the Device Maintenance and Accessory Care sections page 24 Before turning on the power Before turning on the power check for the following External appearance E The device or accessories are not deformed due to falling or other impact The device is not dirty E The device is not wet AC adapter E The AC adapter is firmly connected to the connector on the device E There are no heavy objects lying on the AC adapter cable E The AC adapter cable is not damaged core wire exposure breaks etc When turning on the power When turning on the power check the following Display lamp When the START STOP button is pressed to turn on the power the screen below appears and the alarm lamp lights ee The alarm lamp is lit up sys LI i via LOL nm A A L TAER p C CO itm is Bs BS After turning on the power After turning on the power check for the following Extern2. Indicates the matters in which death or severe bodily damage may arise as a result A Warning of incorrect handling A Indicates the matters in which bodily harm or material damage may arise as a result A Caution of incorrect handling General Information Note Indicates general information to keep in mind when using the unit and other useful information Warnings and Cautions Usage warnings and cautions Setup A Warning Do not use the cuff or AC adapter to lift the unit it can also cause the unit to malfunction If the unit has broken down contact OMRON HEALTHCARE Customer Service Do not use in combination with a hyperbaric oxygen therapy device or in an environment where combustible gas may be generated Do not use in combination with magnetic resonance imaging MRI equipment If MRI is to be performed remove cuff connected to the unit from the patient Do not install the unit in the following locations Locations subject to vibration such as ambulances and emergency helicopters A location where there is gas or flame A location where there is water or steam A location where chemicals are stored Do not use at extremely high temperature high humidity or high altitude Use only within the required ambient conditions Do not subject the unit to intense shock Do not place heavy objects on the AC adapter cable or allow the unit to sit on the cord Clinical testing
3. ceceeeee 24 Device Maintenance sas Accessory Calre ccecccceeceeeteetesteeteeees Check before Use c ccecseeeeeeeees Troubleshooting List of Error Codes oe DISPOSAL sissi sirenas Limited Waranty iseanan Specifications Factory Default Settings 0 00000000000 31 Specifications aio Manufacturer s Declaration 0 33 Caution Federal USA law restricts this device to sale by or on the order of a physician or licensed healthcare practitioner Introduction Intended Use Medical Purpose The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult and pediatric patient population with arm circumference ranging from 5 inches to 20 inches from 12 cm to 50 cm Intended User This device should be used by a medical professional Patient Population This device is intended for use on adults and children of age 3 years and older Environment The instrument is designed for use in physicians offices hospitals clinics and other medical facilities Measurement Parameter E Non Invasive Blood Pressure E Pulse rate Precautions for Use Warnings and cautions described in the instruction manual should be observed at all times Exemptions Liability and Warranty OMRON HEALTHCARE does not accept liability and the warranty becomes void under the following circumstances 1 Failures damage or injuries due to mainten
4. 5 SEC Comparison between the auscultatory oscillometric and palpatory methods of measuring blood pressure L A Geddes The Direct and Indirect Measurement of Blood Pressure Year Book Medical Publishers Inc 1970 18 Cuff Selection and Connection Selecting the cuff A Warning Treat a cuff used on a patient with an infection as medical waste or sufficiently sterilize the cuff before reuse A Caution Do not use the cuff if it is damaged or has holes e Use the appropriate cuff size to ensure correct measurements If too large a cuff is used the measured blood pressure value tends to be lower than the actual blood pressure If too small a cuff is used the measured blood pressure value tends to be higher Note It is important to use the correct sized cuff for a patient in order to get an accurate reading Measure the circumference of the patient s arm and select the cuff size that is appropriate for the circumference Select the cuff that is suitable for the patient from the cuffs below Arm circumference Cuff name inch cm GS CUFF XL GCUFF XL 17 20 42 50 GS CUFF L GCUFF L 13 17 32 42 GS CUFF M GCUFF M 9 13 22 32 GS CUFF S GCUFF S 7 9 17 22 GS CUFF SS GCUFF SS 5 7 12 18 Available as an optional accessory Connecting the cuff Connect the cuff tube to the NIBP connector on the unit and turn clockwise to lock A Caution Only OMRON
5. address phone number and description of the specific problem Pack the product carefully to prevent damage in transit Because of possible loss in transit we recommend insuring the product with return receipt requested THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS PRODUCT AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING IMPLIED 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 OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL INCIDENTAL CONSEQUENTIAL OR INDIRECT COSTS EXPENSES OR DAMAGES This warranty provides you with specific legal rights and you may have other rights that vary by jurisdiction Because of special local requirements some of the above limitations and exclusions may not apply to you FOR CUSTOMER SERVICE Call toll free 1 877 216 1336 30 Specifications Factory Default Settings Factory default settings and backup are as shown below Backup O Setting is retained even if the power is interrupted Z Reverts to factory default setting if the power is turned off Setting Pressure Value Settings Factory Setting Backup Initial Inflation Pressure Value AUTO 220 250 280 AUTO A Auscultation Mode ON OFF OFF A Auto Power Off 5 min 10 min 5 min O S
6. displayed the measured data is cleared without being stored When the monitor is left idle for one minute the backlight will disappear 23 Non Invasive Blood Pressure NIBP Measurement Maintenance Maintenance Inspection and Safety Management The HBP 1300 must be maintained to ensure functionality and to secure the safety of patients and operators Daily checks and maintenance should be performed by the operator page 25 In addition qualified personnel are necessary to maintain the performance and the safety and to conduct periodic inspections We recommend that the verification test be performed at least once a year page 17 Managing Supplies Keep the following supplies on hand e GS CUFF All sizes Device Maintenance Cleaning and disinfecting should be performed in accordance with your facility s infection control practice and OSHA regulations Surface cleaning Wipe with a cloth that has been moistened with isopropyl alcohol diluted to 50 v v or ethyl alcohol disinfection alcohol diluted to 76 9 81 4 v v and wrung out Do not wipe the DC jack or allow it to become wet Removing dust Use a moistened cotton bud to remove dust that has accumulated on the vent ports Service The device requires no routine service other than cleaning and visually checking the cuffs tubing etc AN Caution e Do not sterilize by autoclave or gas sterilization EOG formaldehyde gas high concentration ozone etc
7. 39 mmHg or less or 201 mmHg or higher PULSE 39 bpm or less or 201 bpm or higher E Normal measurement E Measurement error failure ib E Con A Caution The accuracy of a flashing measurement value that is outside the measurement range is not guaranteed Always check the patient s condition before deciding what steps to take Note If inflation is insufficient inflation may restart while measurement is in progress 21 Non Invasive Blood Pressure NIBP Measurement Irregular pulse wave detection function If the pulse wave interval becomes irregular during measurement the irregular pulse wave detection icon will light to notify you Body movement detection function If body movement is detected during measurement deflation stops for 5 seconds The irregular pulse wave icon appears in the measurement result display E Deflation stopped After 5 seconds measurement resumes and an attempt is made to complete measurement in one cycle Taking the Measurement in Auscultation Mode Use a stethoscope to perform measurement When set to ON SYS and DIA can be recorded using auscultation measurement To determine SYS and DIA during measurement press the MODE button SYS is registered the first time and DIA is registered the second time you press the MODE button during deflation After DIA is determined the cuff rapidly deflates and SYS and DIA are displayed as the measurement results The pulse ra
8. The measurement time exceeds the expected time so the measurement was ended in order to avoid patient discomfort There is a possibility that measurement is being repeated over and over due to air leaking from the cuff Measurement time has exceeded specified time Specified time 165 seconds 28 Other problems Error Priority Cause Solution code Inflated the cuff to 300 mmHg or more When inflating in Auscultation Mode weak whens akg s 7 release the button when the pressure during inflation in Auscultation Mode reaches the desired value E3 L w If this occurs during measurement repeat measurement Over inflation occurs If this occurs when not performing measurement contact OMRON HEALTHCARE Customer Service E40 Medium The battery is depleted Recharge the battery or replace with a new battery page 14 r Try charging again If continues to fail E41 Medium Battery failed to charge replace with a new battery page 14 Replace the battery with a new battery If the E42 Medium Battery voltage error error continues contact OMRON HEALTHCARE Customer Service Disposal Description As there is a risk of environmental pollution follow your applicable Federal state and local legal regulations regarding disposal or recycling of this equipment and batteries The main constituents of each part are listed in the table below As there is a risk of infection do not r
9. When the unit is powered by the battery pack and is not used for the set time 5 min or 10 min the power automatically turns off to save battery power If an alarm has occurred the power does not turn off automatically 4 When you have completed the Auto Power Off setting press the MODE button The Pressure Accuracy Confirmation screen appears 0 appears m 5 Check the Pressure Accuracy LJ Change the pressure externally m 0 appears Compare with the displayed value and verify that there is no problem LJ 6 When you have completed Pressure Accuracy Confirmation press the START STOP button The power turns off Example 1 Connect the blood pressure monitor the standard pressure gauge and the cuff and rubber ball For details on the standard pressure gauge contact OMRON HEALTHCARE Customer Service 2 Check the blood pressure value of the blood pressure monitor and the blood pressure value of the standard pressure gauge Note e The standard is within 3 mmHg or 2 of manometer reading To rapidly deflate the cuff press the lt q button To repeat Pressure Accuracy Confirmation turn off the power and repeat the procedure from step 1 of Utility Mode 17 System Settings Non Invasive Blood Pressure NIBP Measurement Non Invasive Pressure Measurement Principles Oscillometric method The beat in the pulsation generated by the contraction of the heart is captured as the pres
10. has not been conducted on newborn infants and pregnant women Do not use on newborn infants and pregnant women Do not plug in or unplug the AC adapter with wet hands A Caution Do not install the unit in the following locations Locations with dust salt or sulfur Locations directly exposed to sunlight for extended periods of time in particular do not leave in direct sunlight or near a source of ultraviolet light for extended periods as ultraviolet light will cause deterioration of the LCD Locations subject to vibration or shock Near heaters Do not use the unit near large equipment that uses a switching relay for power ON OFF Introduction Before use during use A Warning The unit complies with the EMC standard IEC60601 1 2 As such it can be used simultaneously with multiple medical instruments However if instruments that generate noise such as an electric scalpel or a microwave therapy device are near the unit check the operation of the unit during and after use of these instruments If an error occurs or a measurement result is questionable check the vital signs of the patient by auscultation or palpation Avoid relying solely on the measurement results of the unit when judging the patient s condition Only trained healthcare providers should use this device Do not allow patients to operate this device Properly connect the connectors and AC adapter cable Do n
11. of objects If the unit becomes too hot to be touched there may be a problem in the unit Turn off the unit power disconnect the AC adapter remove the battery and contact OMRON HEALTHCARE Customer Service at 1 877 216 1336 The unit is connected to a power outlet but it runs on the the battery pack Cause solution If AC power cannot be supplied the unit will operate by battery only e Check if the AC adapter is properly connected to the unit e Check if AC adapter is connected to a power outlet e Check that the electrical outlet is working by connecting a different device to the same power outlet The cuff does not inflate when the START STOP button is pressed Cause Solution Loose cuff tube connection Check the connection There is an air leak in the cuff Replace the cuff If pressure is displayed the cuff tube is bent Make sure no part of the cuff tube is bent Measurement was not possible Cause solution Check the patient by palpation or other method After checking the patient check the error code and see List of Error Codes page 28 for Non Invasive Blood Pressure NIBP measurement 26 Abnormal measurement value Cause solution The causes below are possible Check the patient by palpation and then repeat measurement Body movement chills or other trembling e Arrhythmia e Noise in the cuff A nearby person touched the pati
12. Charging automatically starts after the AC adapter is connected When a new battery pack or a battery pack that has not been used for a long time is used some time may elapse before charging starts e The ___ icon flashes during charging e Charging is completed in about 4 hours Low battery When the __ icon starts flashing promptly charge the battery pack When the icon changes to E the battery is too low for blood pressure measurement Charge the battery Auto Power Off When the unit is powered by the optional battery pack the power automatically turns off after the set time elapses if you forget to turn off the power When the unit is used with the AC adapter connected the Auto Power Off setting does not operate 14 Battery charging State LCD contents and operations Icon Charging The icon is flashed C_ Fully charged Charging completed Theicoi silit L Problem with the battery Error message is displayed 3 Battery level Battery level LCD contents and operations Icon Fully charged The icon is lit y 9 The unit can be used LEA The icon is flashed E40 error not displayed 0 Battery level 15 20 The unit can be used A The icon is flashed E40 error displayed The unit cannot be used i 9 Banery vel a If the unit is being continuously used the power will be tt automatically turned off in 30 seconds Connecting the AC Ad
13. GS CUFF can be used with this device Note e If the cuff tube is too short the optional 3 5 m or 1 5 m CUFF HOSE can be connected to lengthen the cuff tube Do not make the hose longer than 3 5 m as this will affect measurement accuracy e Make sure the connections are tight 19 Non Invasive Blood Pressure NIBP Measurement Applying the Cuff to the Patient 1 Wrap on a bare arm or over thin clothing Wrap the cuff on a bare arm or over thin clothing Thick clothing or a rolled up sleeve will cause inaccurate blood pressure measurements The device can be used on either the right or left arm lt 2 Align the artery mark INDEXWARTERY with the brachial artery INDEX Wy ARTERY N Run the cuff tube out the peripheral side with no bends the brachial artery is on the inner side of the patient s upper arm Make sure that INDEX W ARTERY is within the RANGE and the lower edge of the cuff is 1 2 1 inches from the inner side of the elbow joint If INDEX W ARTERY is outside the RANGE error in the blood pressure value will increase In this case use a different cuff size As a guideline for the tightness of the cuff It should be possible to insert about two fingers under the cuff 1 2 1 n 3 During measurement keep the brachial artery on which the cuff is wrapped at the same height as the right atrium of the heart 20 A Caution Make sure the cuff is wrapped in the correct arm posit
14. HBP 1300 Over the frequency range 150 kHz to 80MH2z field strengths should be less than 3 V m 34 Note POTENTIAL FOR RADIO TELEVISION INTERFERENCE for U S A only This product 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 The product 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 the product does cause harmful interference to radio or television reception which can be determined by turning the product on and off the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the product and the receiver e Connect the product into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help POTENTIAL FOR RADIO TELEVISION INTERFERENCE for Canada only This digital apparatus does not exceed the Class B limits for radio noise emissions from digital apparatus as set out in the interference causing equipment stand
15. OMRON Professional Blood Pressure Monitor HBP 1300 Instruction Manual Thank you for purchasing this OMRON Professional Blood Pressure Monitor Please competely read this Instruction Manual before using the monitor for the first time Read this manual to ensure the safe and accurate use of the monitor For Professional Use KEEP THIS INSTRUCTION MANUAL NEAR THE BLOOD PRESSURE MONITOR FOR FUTURE REFERENCE Table of Contents Introduction intended WSC arcera tenn eninin Exemptions Notes on Safety Pe Warnings and Cautions 3 Using the Unit Components of the Product 05 10 Optional Accessories lO Features of the Product ccceee 11 Features Functions of Unit Installing the Optional Battery Pack 14 Connecting the AC Adaptet 06 15 System Settings M n Moden scstesiencirties nidoni 16 Utility MOJE sien Anish enue cas 17 Non Invasive Blood Pressure NIBP Measurement Non Invasive Pressure Measurement Principles 18 Cuff Selection and Connection 19 Applying the Cuff to Patient 20 Taking the Measurement in Manual Mode 21 Taking the Measurement in Auscultation Mode 22 Stopping the Measurement 5 23 Displaying Last Reading 008 23 Maintenance Maintenance Inspection and Safety Management 24 Managing Supplies 0
16. al appearance E There is no smoke or odor coming from the device E The device is not making any unusual noises Buttons E Press each button and check that it works Non invasive blood pressure NIBP E Make sure that a suitable OMRON GS CUFF is attached one that fits the circumference of the patient s arm E The cuff tube is firmly connected E The person checking the cuff should wrap the cuff around arm perform cuff measurement and check to see that blood pressure is in the vicinity of normal measurements E While measurement is in progress bend the relevant arm and move body to halt discharge and during this halt check that cuff pressure does not drop 25 Maintenance Troubleshooting The power does not turn on Cause Solution If the unit is being powered by the battery the battery is not installed or the charge is depleted Insert battery or replace with a new battery page 14 Disconnect the AC adapter remove the battery and internal ipart failure contact OMRON HEALTHCARE Customer Service e Check if the AC adapter is disconnected or the connection is loose e Check if the AC adapter or battery has failed The unit display does not operate Cause solution Stop using the unit and contact OMRON HEALTHCARE Customer Service The unit becomes hot Cause Solution An object is on top of the unit or right next to the unit Keep the area around the unit free
17. al mode differential mode a typical commercial or hospital 2 kV 2 kV environment 50 60 Hz magnetic field IEC 61000 4 8 Voltage dips short lt 5 Uy lt 5 UT Mains power quality should be that of interruptions and for 0 5 cycle for 0 5 cycle a typical commercial or hospital voltage variations on 40 U 40 U environment If the user of the HBP power supply input lines pores Pome 1300 requires continued operation IEC 61000 4 11 for 5 cycles for 5 cycles during power mains interruptions it is 70 Ur 70 UT recommended that the HBP 1300 be for 25 cycles for 25 cycles powered from an uninterruptible power supply or a battery lt 5 Uy lt 5 Uy for 5 sec for 5 sec Power frequency 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 Uy is the a c mains voltage prior to application of the test level 33 Specifications 80 AM 2Hz 3 IEC60601 1 2 IEC60601 1 2 Electromagnetic Immunity test test level test level environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the HBP 1300 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommend separation distance d 1 2 VP 3 Vrms d 1 2 JP 80 MHz to 800 MHz Conducted RF 150 kHz t
18. ance or repair work performed by persons or a repair facility not authorized by OMRON HEALTHCARE 2 Failures damage or injuries when use and or operation of this device is adversely affected by a device not manufactured by OMRON HEALTHCARE 3 Failures damage or injuries caused by failure to odserve the safety instructions and operational procedures provided in this manual 4 Use and or operation of this unit in conditions that do not conform to the product usage conditions indicated in this manual 5 Failures damage or injuries due to natural catastrophes such as fire earthquake flooding or other natural disasters HBP 1300 Instruction Manual 1 The contents of this manual are subject to change without notice 2 Considerable care has been taken in the preparation of this manual If you suspect there may be an error in the instruction manual please contact OMRON HEALTHCARE by calling 1 877 216 1336 3 Unauthorized reproduction or copying any or this entire instruction manual without the permission of OMRON HEALTHCARE is prohibited by copyright 4 Product brand names shown in this maual are trademarks or registered trademarks of OMRON HEALTHCARE Introduction Notes on Safety The warning signs and symbol examples indicated below are intended to ensure safe use of the product and prevent damage and injury to you and others The signs and symbols are explained below Safety Symbols used in this Instruction Manual
19. apter AC power Verify that the power outlet supplies the specified voltage and frequency 100 240 V AC 50 60 Hz Connect the AC adapter to the DC jack on the unit and the power outlet Note When the optional battery pack is installed If there is no problem with the following AC adapter DC jack Power outlet Battery And the ___ icon does not flash contact OMRON HEALTHCARE Customer Service 15 Using the Unit System Settings The system settings are divided into two modes Menu Mode and Utility Mode Menu Mode Menu Mode allows you to configure the Initial Inflation Pressure Value and Auscultation Mode settings Initial Inflation Auscultation Mode Pressure Value MODE READING 1 Press the MODE button ni The Initial Inflation Pressure Value setting screen appears m 5 2 Press the lt q or p button to change the setting Press the 4q button to change the setting in the order 280 250 220 AUTO 280 e Press the gt button to change the setting in the order 220 250 280 AUTO 220 When the Initial Inflation Pressure Value is set inflation takes place at a fixed speed to the set value and thus is quicker AUTO estimates the systolic blood pressure during inflation and automatically inflates the cuff to a suitable value When using 220 250 or 280 mmHg select the value that is 30 to 40 mmHg higher than the e
20. ard entitled Digital Apparatus ICES 003 of the Canadian Department of Communications Cet appareil num rique respecte les limites de bruits radioel ctriques applicables aux appareils num riques de Clase B prescrites dans la norme sur le materiel brouilleur Appareils Num riques ICES 003 dict e par le minister des communications Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment 35 Specifications Recommended Separation Distances Recommended separation distance between portable and mobile RF communications equipment and the HBP 1300 The HBP 1300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the HBP 1300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the HBP 1300 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m Ay of transmitter 1450 kHz to 80 MHz 80 MHzto 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 12VP d 2 3VP 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 re
21. asurement verify that none of the following apply to the patient An inappropriate cuff size is used The part where the cuff is wrapped is at a different height than the heart A difference of 4 inches 10 cm in height may cause a variation in the blood pressure value of up to 7 or 8 mmHg Body movement or conversing during measurement Cuff wrapped over thick clothing Pressure on the arm due to a rolled up sleeve In the case of a cuff for adults the cuff should be wrapped to a tightness that allows two fingers to be inserted in between the cuff and the arm The accuracy of a flashing measurement value that is out of the measurement range cannot be guaranteed Always check the patient s condition before deciding what steps to take Do not use the cuff if it is damaged or has holes Only OMRON GS CUFF can be used with this device Note Setup e Read and understand the manual for each optional accessory This manual does not contain cautionary information for optional accessory e Exercise caution with the cables and arrange so that the patient does not become entangled or bound Before use during use e Check the following after turning on the power No smoke abnormal odor or abnormal sound is emitted Press each button and verify that it operates For functions that cause icons to light or flash verify that the icons light or flash Measurement can be performed normally and measure
22. commended separation distance d in metres 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 Note1 At 80MHz and 800MHz the separation distance for the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 36 For Customer Service Call Toll Free 1 877 216 1336 Manufactured by OMRON HEALTHCARE Co Ltd OMRON HEALTHCARE INC Distributed by 1925 West Field Court Lake Forest IL 60045 USA Made in China 2012 OMRON HEALTHCARE INC
23. dy movement is detected the device stops deflation for 5 seconds e Irregular pulse Indicator Helps identify changes in heart rate rhythm or pulse which may be caused by heart disease or other serious health issues Inflation Pressure Setting 4 options Auto 220 mmHg 250 mmHg 280 mmHg e Last reading display function e Auto Off e Custom Rechargeable battery e Large easy to read backlight display 11 Using the Unit Features Functions of Unit Front and back of unit START STOP button Power ON OFF Power ON Measure blood pressure Press when the power is off to turn on the power and start blood pressure measurement During inflation or measurement press to stop Power OFF Hold down at least 3 seconds to turn off the power MODE Press to enter Menu Mode and configure various settings If held down at least 3 seconds when a measurement result 2 MODE bution is displayed the measured data is cleared without being stored in memory ist Displays the system settings page 16 and the last reading 3 TAN lt q gt button page 23 When using Auscultation Mode inflates and deflates the cuff 4 Alarm lamp Lights up or flashes when an alarm occurs page 28 5 NIBP connector Connects the cuff tube 6 DC jack Connects the AC adapter 7 Battery cover Open to install or replace the battery Meaning of the Symbols Symbol Description Symbol Descri
24. ecycle patient attachments such as cuffs but dispose of them as instructed by your facility s procedures and applicable regulations Item Parts Material Box Cardboard Package Cushion Cardboard Bag PE Main unit and Enclosure ABS PC SR accessories Internal parts General electronic components Outer tube PVC Battery pack Cell batteries Nickel hydrogen battery Internal parts General electronic components 29 Maintenance Limited Warranty Your OMRON HBP 1300 Professional Blood Pressure Monitor excluding the arm cuffs is warranted to be free from defects in materials and workmanship appearing within 2 years from the date of purchase when used in accordance with the instructions provided with the unit The arm cuffs are warranted to be free from defects in materials and workmanship appearing within one year from the date of purchase when used in accordance with the instructions provided with the unit The above warranties extend only to the original retail purchaser We will at our option repair or replace without charge any unit or arm cuffs covered by the above warranties Repair or replacement is our only responsibility and your only remedy under the above warranties To obtain warranty service contact Customer Service by calling 1 877 216 1336 for the address of the repair location and the return shipping and handling fee Enclose the Proof of Purchase Include a letter with your name
25. ent Cardiac massage was being performed The measurement value is questionable Cause Solution Deflates quickly Check for a loose cuff connection Stethoscope Simultaneously perform measurement with a stethoscope Place the stethoscope and listen while viewing the pressure display of the manometer Blood pressure may vary widely due to physiological effects The causes below are possible Emotional excitement or agitation Pain due to cuff wrapping White coat hypertension Cuff size or wrapping method not correct Cuff wrapping position on upper arm not at the same height as the heart e Patient s blood pressure not stable due to pulsus alternans respiratory changes or other reason Measure circumference or patient s arm and ensure Incorrect cuff size used correct sized cuff is used Ensure cuff is applied to a bare arm or very thin Cuff wrapped over thick clothing clothing Ensure patient is seated feet flat on the floor cuff at Patient not seated properly heart level Ensure before measurement taken patient has not Patient ate drank or exerted themselves recently had food caffeinated or alcohol beverages or exerted exercised in the last 30 minutes 27 Maintenance List of Error Codes The alarm lamp flashes when a medium priority alarm occurs and lights steadily when a low priority alarm occurs To clear an alarm press any button E f al
26. ent Electromagnetic Emissions IEC60601 1 2 Emission Test Compliance Electromagnetic Environment RF emission Group 1 The HBP 1300 uses RF energy only for internal functions CISPR 11 Therefore this RF emission is extremely weak and there is little chance of it creating any kind of interference whatsoever with nearby electronic equipment RF emissions Class B The HBP 1300 is suitable for use in all establishments CISPR 11 including domestic establishments and those directly Harmonic emissions Class A alten to ee Se ae ae supply network IEC 61000 3 2 at supplies buildings used for domestic purposes Voltage fluctuations flicker Complies IEC 61000 3 3 Electromagnetic Immunity IEC60601 1 2 E IEC60601 1 2 Electromagnetic Immunity test Compliance level i test level environment guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ESD 8 kV air 8 kV air ceramic tile If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Electric fast transient 2 kV for 2 kV for Mains power quality should be that of common mode common mode burst power supply lines power supply lines a typical commercial or hospital IEC 61000 4 4 1 kV for 1 kV for environment input output lines input output lines Surge 1 kV 1 kV Mains power quality should be that of IEC 61000 4 5 differenti
27. ion and is at the same height as the heart A difference of 4 inches 10 cm in height may cause a variation in the blood pressure value of up to 7 8 mmHg Note e If measurement is difficult due to arrhythmia use a different blood pressure measurement method e If the patient has acute inflammation a pyogenic ailment or an external wound at the location where the cuff is to be wrapped follow the instructions of the doctor e Non Invasive Blood Pressure NIBP measurement is performed by compressing the upper arm Some people may experience intense pain or transient spotting caused by subcutaneous hemorrhaging may appear The spotting will disappear over time however if it is possible that this will disturb the patient try the following technique Wrap a thin towel or cloth one layer under the cuff If the towel or cloth is too thick there will be insufficient cuff compression and the blood pressure value will measure high e If the patient moves or the cuff is touched this may be falsely detected as a pulse and over inflation will occur Do not inflate the cuff when it is not wrapped on the upper arm This may damage the cuff Taking the Measurement in Manual Mode 1 Press the START STOP button Blood pressure measurement is performed once 2 The measurement results are displayed If a measurement value is outside the corresponding range below the value will flash SYS 59 mmHg or less or 251 mmHg or higher DIA
28. ment Introduction Using the Unit Components of the Product Before using the unit make sure that no accessories are missing and that the unit and accessories are not damaged If an accessory is missing or there is damage please contact OMRON HEALTHCARE Customer Service Main unit Standard accessories AC adapter GS CUFF L and M Instruction Manual Optional Accessories oc uuu Wall mount kit Battery pack AC adapter WMKIT 1300 BAT 2000 AC 1300Z HXA WMKIT 1300 HXA BAT 2000 60120H1040SW Z 10 GS CUFF XL GCUFF XL HXA GCUFF XLLB GS CUFF L GCUFF L HXA GCUFF LLB GS CUFF M GCUFF M HXA GCUFF MLB o GS CUFF S GCUFF S HXA GCUFF SLB GS CUFF SS GCUFF SS HXA GCUFF SSLB CUFF HOSE 3 5 m HOSE15ZZ A015ZZ CUFF HOSE 1 5m HOSE16ZZ A016ZZ A Caution Only OMRON GS CUFF can be used with this device Features of the Product The OMRON HBP 1300 is an affordable professional blood pressure unit that is clinically proven accurate and provides fast reliable results and is easy to use Key features benefits look e 5 cuffs available SS 5 to 7 inches S 7 to 9 inches M 9 to 13 inches L 13 to 17 inches XL 17 to 20 inches 5 to 20 inches arm circumference range e Designed to be used on a table or mounted on the wall e Motion stop function When bo
29. ment error is within the tolerance value e If the screen is not displayed normally do not use the unit e When recycling or disposing of parts including batteries of the unit follow local government rules and regulations Cleaning e For cleaning see page 24 Optional rechargeable battery e To prevent accidents keep batteries out of reach of infants and small children e If you sense that something is wrong with a battery immediately move it to a safe location and contact the administrator responsible for the unit or OMRON HEALTHCARE Customer Service e If the battery voltage is low operation by battery may not be possible Non Invasive Blood Pressure NIBP measurement If the patient has acute inflammation a pyogenic ailment or an external wound at the location where the cuff is to be wrapped follow the instructions of the doctor e Non Invasive Blood Pressure measurement NIBP is performed by compressing the upper arm Some people may experience intense pain or transient spotting caused by subcutaneous hemorrhaging bruising may appear The spotting will disappear with time however it may be appropriate to inform patients for whom this may be a concern that spotting sometimes occurs and if necessary refrain from measurement To measure correctly it is recommended that the patient relax and not talk during measurement e To measure correctly it is recommended that the patient rest quietly for 5 minutes before measure
30. n treat the cuff as medical waste or sterilize before reuse If frequently performing NIBP measurement using a cuff over an extended period of time periodically check the patient s circulation In addition wrap the cuff as indicated in the cautionary points in this manual Do not connect the NIBP cuff or cuff joint to a luer lock adapter Do not bend cuff tube during inflation and deflation particularly after a change of body position Do not wrap the cuff on the following parts An upper arm on which intravenous drip or a blood transfusion is being performed An upper arm on which an SpO sensor IBP catheter or other instrument is attached An upper arm with a shunt for hemodialysis If measuring blood pressure with the cuff wrapped on the arm on the side of the body where a mastectomy was performed check the patient s condition A Caution NIBP measurement should be performed on the upper arm During NIBP stop excessive body movement by the patient and minimize trembling If a doctor has indicated that the patient has hemorrhagic diathesis or hypercoagulability check the condition of the arm after measurement Use the appropriate cuff size to ensure correct measurements If too large a cuff is used the measured blood pressure value tends to be lower than the actual blood pressure If too small a cuff is used the measured blood pressure value tends to be higher Before and during me
31. o 80 3 Vrms d 2 3 VP 800 MHz to 2 5 GHz IEC 61000 4 6 MHz 80 AM 2Hz where P is the maximum output power rating of the transmitter in watts W according to he transmitter manufacturer and d is the recom mended separation distance in meters m 3 Vrms Radiated RF 80 MHz to 2 5 i i i IEC 61000 4 3 GHz 3 V m Field strengths from fixed RF transmitters as determined 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 Co Note1 At 80 MHz and 800 MHz the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 HBP 1300 is used exceeds the applicable RF compliance level above the HBP 1300 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the
32. ot place objects or liquids on top of this unit Check the following before using the unit Make sure the AC adapter cable is not damaged wires are not exposed or broken and the connections are firm For the AC adapter connected to the unit supplies and optional devices use only the standard accessories or OMRON specified products Do not use in a location with moisture or a location where water may splash on the unit This unit is intended for use in a physician s office Do not use the unit if it emits smoke an abnormal odor or abnormal noise Do not bring cellular telephones or transceivers into the room where the unit is installed or being used Do not connect multiple monitors to the same patient Do not connect the unit to a power outlet that is controlled by a wall switch A Caution Before using the unit verify that none of the following apply to the patient Poor peripheral circulation noticeably low blood pressure or low body temperature there will be low blood flow to the measurement position The patient uses an artificial heart and lung there will be no pulse An SpO sensor and the cuff are attached to the same arm The patient has an aneurysm The patient has frequent arrhythmia Body motions such as convulsions arterial pulsations or trembling cardiac massage in progress minute continuous vibrations rheumatism etc Before use visually inspect the uni
33. ow priority alarm and a medium priority alarm occur at the same time the medium priority alarm is displayed If the alarms are the same priority level the error code of the alarm that occurred first is displayed However to prevent battery consumption when powered by battery a low battery error E40 error is always given priority E Example E2 D1 gt ca LL SYSTEM Error ee SrA A Priority Description Points to check code Sensor failure Sensor range not stable Outside of sensor range Pressure gain lower limit value upper limit value Pressure sensor count upper limit lower Contact OMRON HEALTHCARE Customer EQ Medium limit error Service EEPROM failure Checksum error Read error Protect code error Switch error Error in switch on state NIBP Error or a P Priority Description Points to check code The cuff tube is not connected Firmly connect the cuff tube E1 Low i Air is leaking from the cuff Replace with an OMRON GS CUFF that does not leak Did not inflate properly because the arm Have the patient not move the arm or body or body moved during measurement and repeat measurement Moved body or arm during Have the patient not talk or move and measurement or talked repeat measurement The cuff is not applied correctly Correctly apply the cuff The sleeve is rolled up and is E2 Low compressing the arm Remove the garment and re wrap the cuff
34. pecifications Main unit Measurement Parameter NIBP Dimension Main unit 4 84 x 7 91 x 3 90 inch 123 x 201 x 99 mm W x H x D AC adapter 1 81 x 2 60 x 1 46 inch 46 x 66 x 37 mm W x H x D Battery 2 13 x 1 71 x 0 61 inch 54 x 43 5 x 15 4 mm W x H x D Weight Main unit Approx 18 34 oz 0 52 kg not including accessories and options AC adapter Approx 7 05 oz 0 2 kg Battery Approx 3 53 oz 0 1 kg optional accessory Display 7 segment LCD UL Classfield WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY Safety Standards IEC 60601 1 1988 A1 1993 A2 1995 UL60601 1 First Edition Medical electrical equipment Part1 General requirements for safety Protection Class Class II Internal powered equipment Degree of Protection Type BF MDD Classification Class Ila 31 Specifications Power supply AC adapter Input voltage range AC 100 V to 240 V Rated Current 1 6 A Frequency 50 60 Hz Output voltage range DC 6 V 5 Optional rechargeable battery Type 3 6 V 1900 mAh Number of operation cycles when fully charged 300 Measurement conditions e New battery fully charged Ambient temperature of 23 C 73 4 F e Using M size cuff e SYS 120 DIA 80 PR 60 Inflation setting AUTO One 5 minute cycle consisting of cuff measurement time wait time Environmental Conditions Operational temperature and humidit
35. ption e This shows the type BF device Ci Refer to manual MEDICAL EQUIPMENT o WITH RESPECT TO ELECTRICAL c US SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 and CAN CSA C22 2 No 601 1 12 LCD Display NO A 5 See dhh i jay oml mju pumy gO oo LIL nS Yas Oo 9 05 i 220 D D f 10 1 SYS Displays systolic blood pressure DIA Displays diastolic blood pressure Pulse Displays the pulse rate 4 IA Pulse Flashes in synchronization with the pulse during 1A synchronization icon measurement iir gular pulse wave Lights in the measurement result display and memory 5 9 ea P display if the pulse wave interval was irregular or there was body movement during measurement page 23 6 Memory icon Lights while the previous data are being displayed page 23 7 A Charge icon Flashes during charging Solid colored light displays when charging is finished Battery charge level 3 Zi icon Displays how much charge the battery has page 14 9 OF Auscultation icon Lights when Auscultation Mode is ON page 16 Inflation setting icon The set initial Inflation pressure value lights page 16 Only when the optional battery is installed 13 Using the Unit Installing the Optional Battery Pack A Warning e If battery fluid comes in contact with the eye immediatel
36. stimated systolic blood pressure 3 When you have completed the Initial Inflation Pressure Value setting press the MODE button m 5 LJ The Auscultation Mode settings screen appears ON or OFF m appears 4 Press the 4 or p button to set to ON or OFF When set to ON SYS and DIA can be recorded using auscultation measurement For information on auscultation measurement see page 22 5 When you have completed the Auscultation Mode setting press the MODE button 0 appears To start blood pressure measurement press the START STOP button Note The body movement detection function is disabled while Auscultation Mode is in use If the power is turned off the settings revert to the factory settings Initial Inflation Pressure Value changes to AUTO and Auscultation Mode changes to OFF 16 Utility Mode Utility Mode allows you to configure the Auto Power Off and Pressure Accuracy Confirmation setting Oo START STOP LAST MODE READING 000 1 Confirm that the device is switched off l p E 2 Hold down the MODE button until the mm Oo Auto Power Off setting screen appears r 5 5 The Initial Inflation Pressure Value setting screen appears and changes to the Auto Power Off setting screen appears 5 or 10 appears 3 Press the lt q or p gt button to change the auto power off setting The 5 min or 10 min setting is entered
37. sure inside the cuff to measure the blood pressure If the cuff wrapped around the upper arm is pressurized sufficiently the blood flow stops but the beat of the pulsation is present and the pressure inside the cuff receives this and oscillates Next as the pressure inside the cuff gradually decreases the oscillation of the pressure within the cuff gradually increases and reaches a peak As the pressure within the cuff decreases further the oscillation decreases from its peak The pressure within the cuff and the relationship with the increase and decrease of the oscillation within the cuff in this series of processes are stored into memory calculations are carried out and the blood pressure value is determined The pressure within the cuff when the oscillation increases drastically is the systolic pressure and the pressure within the cuff when the oscillation decreases drastically is the diastolic pressure Also the pressure within the cuff when the oscillation peaks is taken as the average pulsation pressure The oscillometric method does not determine the blood pressure value instantly like a microphone type automatic blood pressure gauge with the auscultation method but rather determines it from the series of change curves as explained above Therefore it is not easily affected by external noise an electric scalpel or other electro surgical instruments KOROTKOV SOUNDS CUFF PRESSURE OSCILLATIONS IN CUFF PRESSURE RADIAL PULSE
38. t to make sure there are no deformations due to falling and that there is no dirt or moisture on the unit When the unit has not been used for an extended period of time always verify that it operates normally and safely before use Do not use in a location where the unit may easily fall In the event that the unit falls verify that it operates normally and safely Introduction Cleaning A Warning When cleaning the unit turn off the power and disconnect the AC adapter from the unit After cleaning the unit make sure it is completely dry before connecting to a power outlet Do not spray pour or spill liquids into or onto the unit accessories connectors buttons or openings in the housing AN Caution Do not use thinner benzene or other solvents to clean the unit Do not sterilize by autoclave or gas sterilization EOG formaldehyde gas high concentration ozone etc If using an antiseptic solution for cleaning follow the instructions of the manufacturer Clean the unit regularly Maintenance and inspection A Warning To use the unity safely and correctly always inspect the unit when starting work Unauthorized modification is prohibited by law Do not attempt to disassemble or modify the unit Warnings and cautions for safe measurement Optional rechargeable battery A Warning If battery fluid comes in contact with the eye immediately flush with copio
39. te does not appear in the measurement result display During deflation the gt gt button can be held down to re inflate or the lt button can be held down to deflate faster Stored data that was measured in Auscultation Mode is displayed when the auscultation icon is lit E During re inflation ma Note The body movement detection function is disabled while Auscultation Mode is in use For Auscultation Mode settings see page 16 22 Stopping the Measurement To stop measurement while measurement is in progress press START STOP button Displaying Last Reading The previous measurement value systolic blood pressure diastolic blood pressure and pulse rate and whether or not an irregular pulse wave was detected can be displayed In the case of auscultation measurement the auscultation icon appears Press the lt q or gt button to display the previous data This function is also available when the device is switched off If an irregular pulse wave or body movement was detected the irregular pulse wave icon appears When the data was measured in Auscultation Mode the auscultation icon appears Note SYS mmHg DIA mmHg T purse RS Purse O E E MODE READING a ic B we 63 oe START STOP A ia Lights while the previous data are being displayed If held down at least 3 seconds when a measurement result is
40. us amounts of water Do not rub Seek medical attention immediately Do not use the optional battery pack in any other device besides this unit Do not throw into flame disassemble or heat Always disconnect the AC adapter from the unit before removing or installing a battery If the unit will not be used for a month or longer remove the battery from the unit and store Charge the battery once every 6 months Storage conditions for the battery are a temperature of 20 to 30 C 4 to 86 F and a humidity of 65 20 Before use always charge the battery Do not attempt to disassemble or modify the battery Do not apply pressure to and deform the battery Do not throw pound drop bend or hit the battery The battery has positive negative polarity If the battery does not connect well to the unit do not forcibly connect it Do not connect the positive and negative terminals of the battery with a wire or other metal object Do not carry or store a battery with metal necklaces hairpins or other metal objects Use only the specified type of battery A Caution Do not touch the positive and negative terminals of the optional battery pack with a wire or other metal object If battery fluid comes into contact with the skin or clothes immediately rinse with water Introduction Non Invasive Blood Pressure NIBP measurement A Warning If a cuff is used on a patient with an infectio
41. y Temperature range 5 to 40 C 41 to 104 F Humidity range 15 to 85 RH not condensed Atmospheric pressure 700 to 1060hPa Storage and transportation Temperature range 20 to 60 C 4 to 140 F Humidity range 10 to 95 RH not condensed Atmospheric pressure 500 to 1060hPa EMC Reference standard IEC60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests Non Invasive Blood Pressure NIBP Measurement technology Oscillometric Measurement method Dynamic Linear Deflation method Pressure display range 0 to 300 mmHg Pressure display accuracy Within 3 mmHg or 2 NIBP measurement range SYS 60 to 250 mmHg DIA 40 to 200 mmHg Pulse rate 40 to 200 min NIBP accuracy Maximum mean error within 5mmHg Maximum standard deviation within 8mmHg Pulse rate accuracy Within 5 of reading Reference standard IEC 80601 2 30 2009 ANSI AAMI SP 10 2002 A1 2003 A2 2006 R 2008 1S081060 2 2009 Comparison with auscultation method performed by a trained professional DIA determined by the auscultation method is K5 32 Manufacturer s Declaration The HBP 1300 is intended for use in the electromagnetic environment specified below The customer or the user of the HBP 1300 should assure that it is used in such an environm
42. y flush with copious amounts of water Do not rub Seek medical attention immediately Do not use the optional battery pack in any other device besides this unit Do not throw into flame disassemble or heat A Caution Do not short the positive and negative terminals of the optional battery pack with a wire or other metal object If battery fluid comes into contact with the skin or clothes immediately rinse with water 1 Make sure the AC adapter has been disconnected 2 Remove the two screws from the top of the rear unit cover and remove the battery cover 3 Connect the battery pack to the connector on the monitor and insert the battery pack into the compartment so that the triangle mark on the battery pack is aligned with the triangle mark on the monitor 4 Replace the battery cover and secure with screws Take care not to pinch the wires when replacing the cover 5 Connect the AC adapter to the unit and charge the battery pack When using the battery pack for the first time be sure to fully charge about 4 hours before using Battery life e About 300 measurements are possible with one charge A general guideline for replacement of the battery pack is about one year however the usage time per charge may grow shorter depending on usage conditions If you find that the usage time after each charge has grown shorter and the __ icon frequently appears replace the battery pack Charging time
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