HBP-1100 Instruction Manual
Contents
1. appear Stopping the Measurement To stop measurement while measurement is in progress press START STOP button 21 Non Invasive Pressure Measurement Principles Oscillometric method The beat in the pulsation generated by the contraction of the heart is captured as the pressure inside the cuff to measure the blood pressure If the cuff wrappe 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 are i 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 pecilaton 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 w2. Maintenance Maintenance Inspection and Safety Management 00 0 23 Device Maintenance ccccccceecsceeeeeeeeeceeneeeeesaeeeseaeeeeteeeeeteaeees 23 Accessory Cale minnir sri ea ei Se eee 23 Managing Supplies cccccccecceeeeeeeeeeeeeeeeeseneeeeeeaeeesecaeeeseaeees 23 Check before US rsiegorrarenii ninaa ariaa a waive reste 24 Checking pressure ACCUACY eccceeeeeeeeeeeeeeeeeneeeeeneeeeeeneeeteaes 25 Troubleshooting i io en irdena rae aa niles 26 Listiof Error CodeS an a eee a a eA 29 Disposal sst heid A a a 31 Specifications Specification Siaran a Ge A See eee eee 32 Manufacturer s Declaration ccccccceeeeeceeeeeeeeeeeneeeeteseeeeeaeees 36 Optional Accessories Optional Medical Accessories cccceeeeeeeeeeeeeeeeeneeeeeeteeeteaes 40 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 12 cm to 50 cm from 5 inches to 20 inches 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 Precauti
3. ae establishments including domestic PN Class A establishments and those directly connected to the public low voltage power supply network Voltage fluctuations that supplies buildings used for domestic flicker Complies purposes IEC 61000 3 3 36 Electromagnetic Immunity IEC60601 1 2 Electric fast transient burst IEC 61000 4 4 power supply lines 1 kV for Immunity test IEC60601 1 2 Compliance Electromagnetic test level level environment guidance Floors should be wood A concrete or ceramic tile e ESD 6 kV contact 6 kV contact If floors are covered with IEC e1001 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 2 kV for 2 kV for power supply lines 1 kV for Mains power quality should be that of a ypical commercial or for 25 cycles input output lines input output lines hospital environment 1 kV 1 kV Mains power quality Surge differential mode differential mode should be that of a IEC 61000 4 5 2 kV 2 kV ypical commercial or common mode common mode hospital environment lt 5 Ur lt 5 Ur Mains power quality Voltage dips short for 0 5 cycle for 0 5 cycle should be that of a interruptions and ypical commercial or voltage variations 40 Uy 40 Ur hospital environment If on power supply for 5 cycles for 5 cycles he user of the HBP input lines 1100 requires continued IEC 61000 4 11 70 Ur 70 Ur operation during
4. mode In auscultation mode this device does not measure blood pressure Measurement should be performed by a health care professional using a stethoscope The healthcare professional uses a stethoscope to determine SYS and DIA by means of the auscultation method 1 Make sure the power is on 0 is displayed 2 Press the Auscultation button m The auscultation icon appears and the us device enters auscultation mode 1P 3 Press the START STOP button GL Inflation starts When the cuff is n sufficiently inflated deflation automatically starts 4 At the SYS point that you determine by auscultation press the Auscultation button The first time you press the Auscultation button the SYS value appears 5 At the DIA point that you determine by auscultation press the Auscultation button The second time you press the Auscultation button the DIA value appears and the cuff rapidly deflates m wy y IL Manual inflation in auscultation mode If the cuff is not inflated sufficiently or you want to re inflate you can inflate the cuff manually Hold down the START STOP button during inflation or deflation to inflate continuously appears below the value to indicate that manual inflation is in progress 05 atd zaJ OQ IN 20 NOTE e The body movement detection function is disabled while Auscultation Mode is in use e In auscultation mode the pulse rate is not measured and does not
5. than cleaning and visually checking the cuffs tubing etc A Caution e Do not sterilize by autoclave or gas sterilization EOG formaldehyde gas high concentration ozone etc e If using an antiseptic solution for cleaning follow the instructions of the manufacturer Accessory Care Non Invasive Blood Pressure Measurement NIBP Cuff Cuf tube 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 in Managing Supplies Keep the following supplies on hand e GS CUFF All sizes Battery 23 Check before Use Before turning on the power Before turning on the power check for the following E External appearance The device or accessories are not deformed due to falling or other impact e The device is not dirty The device is not wet E AC adapter The AC adapter is firmly connected to the connector on the device There are no heavy objects lying on the AC adapter cable The AC adapter cable is not damaged core wire exposure breaks etc When turning on the power When you turn on the power check the LCD display When the START STOP button is pressed to turn on the power the screen sys below appears and the alarm lamp mms lights DIA mmHg PULSE Imin After tur
6. tube to the NIBP connector on the unit and turn clockwise to lock 14 Applying the Cuff to the Patient The device can be used on either the right or left arm Y x Wrap the cuff on a bare arm or over thin clothing Thick clothing or a rolled up sleeve will cause A inaccurate blood pressure measurements 1 Make sure the cuff tube is not bent The cuff tube should be on the peripheral side 2 Wrap the cuff so that the INDEX ARTERY W is directly over the brachial artery The brachial artery is on the inner side of the patient s upper arm Make s sure re that the INDEX ARTERY W is within the range If outside the range there will be areater e error in the blood pressure value In this case use the appropriate cuff size Attach the cuff so that the bottom edge is 1 to 2 cm from the inner side of the elbow joint The cuff should be wrapped to a tightness that roughly allows two fingers to be inserted under the cuff 3 During measurement keep the brachial artery on which the cuff is wrapped at the same height as the right atrium of the heart 15 A Caution Make sure the cuff is wrapped in the correct arm position and is at the same height as the heart NOTE e If measurement is difficult due to arrhythmia use a different blood pressure measurement method lf the patient has acute inflammation a pyogenic ailment or an external wound at the location where the cuff is to be wrapped foll
7. HBP 1100 E A M6 120810 pdf oOmRon Professional Blood Pressure Monitor HBP 1100 Instruction Manual Thank you for purchasing this OMRON Professional Blood Pressure Monitor Please completely 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 All for Healthcare XXXXXXX X A Exemptions OMRON will not bear any responsibilities on the following matters 1 When a problem or damage occurs caused by the maintenance and or repair conducted by a person other than OMRON or the dealer specified by OMRON 2 The problem or damage of OMRON product caused by the product of other manufacturer not delivered by OMRON 3 The problem and damage caused by the maintenance and or repair using the repair parts not specified by OMRON 4 The problem and damage caused by the results not observing the Notes on Safety or the operational method mentioned in this Instruction Manual 5 Under the circumstances not within the operating conditions of this unit including the power source or the setting environment mentioned in this Instruction Manual 6 The problem and damage caused by the result s of remodeling or improper repair of this product 7 The problem and damage caused by act of god such as fire earthquake flood or lightning 1 The contents of this Instruction Manual may be changed without prior notice 2 We have thoroughly
8. IA Displays diastolic blood pressure 3 Pulse Displays the pulse rate wave icon Irregular pulse Lights in the measurement result display if the pulse wave interval was irregular or there was body movement during measurement 5 Qo Auscultation icon Lights when Auscultation Mode is ON 6 M A PUSS oaio Flashes in synchronization with the pulse yr ls during measurement 7 Battery When this icon lights an E40 error also ex replacement icon appears Replace the batteries page 13 Lights when zero calibration is being 8 Zero indicator performed prior to blood pressure icon measurement When calibration finishes OK appears Only when the batteries are installed 12 Installing the Batteries A Warning If battery fluid comes in contact with the eye immediately flush with copious amounts of water Do not rub Seek medical attention immediately Do not throw into flame disassemble or heat Do not attempt to disassemble or modify the battery Do not use the AC adapter and battery at the same time A Caution 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 battery cover from the bottom of the unit 3 Insert the batteries in the correct orientation 4 Replace the battery cover Battery replacement icon When this icon lights an E40 error also appears Replac
9. XA GCUFF Manual SLB SSLB Manufacturer tad OMRON HEALTHCARE Co Ltd 53 Kunotsubo Terado cho Muko Kyoto 617 0002 JAPAN EU representative Ea OMRON HEALTHCARE EUROPE B V Scorpius 33 2132 LR Hoofddorp THE NETHERLANDS www omron healthcare com Asia Pacific HQ OMRON HEALTHACARE SINGAPORE PTE LTD 438A Alexandra Road 05 05 08 Alexandra Technopark Singapore 119967 www omron healthcare com sg Production facility OMRON DALIAN CO LTD Dalian CHINA Made in China
10. arning 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 A 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 lf 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 start ing work Unauthorized modification is prohibited by law Do not attempt to disas semble or modify the unit Dry cell battery A Warning If battery fluid comes in contact with the eye immediately flush with copious amounts of water Do not rub Seek medical attention immediately 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 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 p
11. e the batteries Connecting the AC Adapter 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 power connector on the unit and the power outlet 13 Cuff Selection and Connection A Warning e Treat a cuff used on a patient with an infection as medical waste or sufficiently sterilize the cuff before reuse A Caution e Do not use the cuff if it is damaged or has holes 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 e Only an OMRON GS CUFF can be used with this device The use of any other cuff may result in incorrect measurement Note e It is important to use the correct sized cuff for a patient in order to get an accurate reading Selecting the cuff 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 cm inch GS CUFF XL 42 50 17 20 GS CUFF L 32 42 13 17 GS CUFF M 22 32 9 13 GS CUFF S 17 22 7 9 GS CUFF SS 12 18 5 7 Available as an optional accessory Connecting the cuff Connect the cuff
12. ent Note Setup Read and understand the manual for each optional accessory This manual does not contain cautionary information for optional accessory 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 measurement error is within the tolerance value 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 For cleaning see page 23 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 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 fro
13. eric pressure 700 to 1060hPa Storage and Temperature range 20 to 60 C 4 to 140 F Humidity range 10 to 95 RH not condensed transportation Atmospheric pressure 500 to 1060hPa IEC60601 1 2 2007 Medical electrical equipment EMC Part 1 2 General requirements for basic safety and Reference standard essential performance Collateral standard Electromagnetic compatibility Requirements and tests 33 Non Invasive Blood Pressure NIBP Measurement technology Pulse rate accuracy Measurement method Dynamic Linear Deflation method Pressure display range 0 to 300 mmHg Pressure display Within 3 mmHg or 2 accuracy NIBP SYS 60 to 250 mmHg measurement DIA 40 to 200 mmHg range Pulse rate 40 to 200 min NIBP Maximum mean error within 5 mmHg accuracy Maximum standard deviation within 8 mmHg Pulse rate within 5 of reading accuracy Reference ANSI AAMI SP 10 2002 A1 2003 A2 2006 R 2008 Standard 1SO81060 2 2009 Comparison with auscultation method performed by a trained professional DIA determined by the auscultation method is K5 34 Important information regarding Electro Magnetic Compatibility EMC With the increased number of electronic devices such as PC s and mobile cellular telephones medical devices in use may be susceptible to electromagnetic interference from other devices Electroma
14. essure is displayed the cuff tube Make sure no part of the cuff tube is is bent bent 26 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 29 for Non Invasive Blood Pressure NIBP measurement Abnormal measurement value Cause solution The causes below are possible Check the patient by palpation and then repeat measurement e Body movement chills or other trembling e Arrhythmia e Noise in the cuff Anearby person touched the patient Cardiac massage was being performed 27 The measurement value is questionable Cause Solution Deflates quickly Check for a loose cuff connection Measure circumference or patient s Incorrect cuff size used arm and ensure correct sized cuff is used Ensure cuff is applied to a bare arm Cuff wrapped over thick clothing or very thin clothing Ensure patient is seated feet flat on Patient not seated prop rly the floor cuff at heart level Ensure before measurement taken Patient ate drank or exerted patient has not had food caffeinated themselves recently or alcohol beverages or exerted exercised in the last 30 minutes Simultaneously perform measurement with a stethoscope Stethoscope Place the stethoscope and listen while viewing the pressure display of the manomete
15. f Cuff tube Tube PVC Connector Nickel Enclosure PC AC adapter Code PVC Internal parts General electronic components 31 Specifications Specifications Main unit Measurement NIBP PR Parameter Main unit 120 x 190 x 110 mm 4 72 x 7 48 x 4 33 Dimension inch W x H x D AC adapter 46 x 66 x 37 mm 1 81 x 2 60 x 1 46 inch W x H x D Main unit Approx 0 6 kg not including accessories Weight and options AC adapter Approx 0 2 kg Display 7 segment LCD IEC 60601 1 1988 A1 1993 A2 1995 Safety g Medical electrical equipment Part1 General Standards requirements for safety Protection Class II Class Internal powered equipment Degree of p Protection reer MDD Classification Class Ila Power supply AC adapter Input voltage range AC 100 V to 240 V Rated Current 0 5 A Frequency 50 60 Hz Output voltage range DC 6 V 5 32 Dry cell battery Type AA batteries x4 Number of operation cycles when fully charged 250 e Measurement conditions New battery fully charged AA high performance manganese Ambient temperature of 23 C 73 4 F Using M size cuff SYS120 DIA80 PR60 One 5 minute cycle consisting of cuff measurement time wait time Environmental Conditions Environmental Conditions Temperature range 5 to 40 C 41 to 104 F Humidity range 15 to 85 RH not condensed Atmosph
16. f 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 Before use during use A Warning e 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 not place objects or liquids on top of this unit e 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 m
17. ge below the value will flash SYS 59 mmHg or less or 251 mmHg or higher DIA 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 5881 HB EI BBB 123 9 o ve y Manual inflation in normal mode If the cuff is not sufficiently inflated it can be inflated manually During inflation hold down the START STOP button to inflate continuously appears below the value to indicate that manual inflation is in progress 18 A Caution e 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 e If inflation is insufficient inflation may restart automatically while measurement is in progress 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 Motion stop function If body movement is detected during measurement deflation stops for 5 seconds and blink below the value eA eR rut 2 FaN A After 5 seconds measurement resumes and an attempt is made to complete measurement in one cycle NOTE When the motion stop function has activated the irregular pulse wave icon appears in the measurement result 19 Measurement in auscultation
18. gnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation Medical devices should also not interfere with other devices In order to regulate the requirements for EMC Electro Magnetic Compatibility with the aim to prevent unsafe product situations the EN60601 1 2 2007 standard has been implemented This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices This medical device manufactured by your local OMRON representative conforms to this EN60601 1 2 2007 standard for both immunity and emissions Nevertheless special precautions need to be observed Do not use mobile cellular telephones and other devices which generate strong electrical or electromagnetic fields near the medical device This may result in incorrect operation of the unit and create a potentially unsafe situation Recommendation is to keep a minimum distance of 7 m Verify correct operation of the device in case the distance is shorter Further documentation in accordance with EN60601 1 2 2007 is available within this manual refer to section Manufacturer s Declaration Correct Disposal of This Product Waste Electrical amp Electronic Equipment This marking shown on the product or its literature indicates that it should not be disposed with other household wastes at the end of its working life To p
19. ith 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 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 22 Maintenance Maintenance Inspection and Safety Management The HBP 1100 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 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 Device Maintenance Cleaning and disinfecting should be performed in accordance with your facility s infection control practice 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 Power connector or allow it to become wet Use a moistened cotton bud to remove dust that has accumulated on the vent ports The device requires no routine service other
20. l 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 4 Turn off the power and exit utility mode 25 Troubleshooting The power does not turn on Cause Solution If the unit is being powered by the batteries the batteries are not installed or depleted Insert batteries or replace with new batteries page 13 The AC adapter is disconnected Connect the AC adapter page 13 If the power does not turn on and the above is not the cause turn off the unit power disconnect the AC adapter remove the batteries and contact your local OMRON representative The unit display does not operate Cause solution Stop using the unit and contact your local OMRON representative The unit becomes hot Cause Solution An object is on top of the unit or right Keep the area around the unit free of next to the unit 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 batteries and contact your local OMRON representative 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 pr
21. m measurement To measure correctly it is recommended that the patient relax and not talk during measurement To measure correctly it is recommended that the patient rest quietly for 5 minutes before measurement 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 your local OMRON representative Main unit AC adapter GS CUFF M Instruction Manual A Caution Only an OMRON GS CUFF can be used with this device The use of any other cuff may result in incorrect measurement 10 Features Functions of Unit Front and bottom of unit 1 Power ON OFF Turns the power ON OFF 2 Auscultation button as eet auscultation mode Press to start blood pressure measurement 3 ala While the cuff is inflating hold sTOP unon down to continuously inflate page 18 NIBP connector Connects the cuff tube 5 Power connector Connects the AC adapter 6 Battery cover Hpen 10 install or replace the Other symbols Symbol Description Symbol Description Type BF A Caution Class II o Internal powered equipment 11 LCD Display co co co co CO o Oo m 100 A w CE o z SYS Displays systolic blood pressure 2 D
22. ning on the power After turning on the power check for the following E External appearance There is no smoke or odor coming from the device The device is not making any unusual noises E Buttons e Press each button and check that it works E Non invasive blood pressure NIBP 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 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 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 24 Checking pressure accuracy You can check the pressure accuracy of the device Power ON OFF __ oe STARTO START STOP button power Op sTOP button Auscultation es button 1 Make sure the power is on 2 Hold down the Auscultation button for 3 seconds Zero calibration is performed When calibration is finished the pressure accuracy verification screen appears 3 Check the 0 display and perform the pressure accuracy check 0 Apply the external pressure n nge Compare with the displayed value and make sure uu there is no problem Example 1 Connect the blood pressure monitor the standard pressure gauge and the cuff and rubber bal
23. o keep in mind when using the unit and other useful information 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 your local OMRON representative 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 use with a defibrillator 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 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 o
24. oisture 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 4 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 unit 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 Cleaning A W
25. omfort There is a possibility that measurement is being repeated over and over due to air leaking from the cuff 29 Other problems Error code Description Points to check E3 Cuff inflated to 300 mmHg or higher during manual inflation in auscultation mode When inflating manually in auscultation mode release the button when the pressure reaches the desired value Over inflation occurs If this occurs during measurement repeat measurement If this occurs when not performing measurement contact your local OMRON representative E40 The batteries are depleted Replace with new batteries page 13 E42 Battery voltage error Replace the batteries with new batteries If the error continues contact your local OMRON representative 30 Disposal As there is a risk of environmental pollution follow your applicable national 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 recycle 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 Maile Enclosure ABS PC SR Intererna General electronic components Battery AA battery ae Cuff C3604B Cuf
26. ons for Use Warnings and cautions described in the instruction manual should be observed at all times Features of the Product The blood pressure accuracy of the HBP 1100 is clinically proven Easy to use the HBP 1100 is intended for use by medical professionals E Zero indicator function page 14 Before each measurement this device indicates that zero calibration was successful E Auscultation mode E 5 cuffs available XL 42 to 50 cm L 32 to 42 cm M 22 to 32 cm S 17 to 22 cm SS 12 to 18 cm E This device and cuff can be cleaned with a soft cloth moistened with alcohol E Compact can be stored in a drawer E Motion stop function When body movement is detected this device stops deflation for 5 seconds E Irregular pulse icon Helps identify changes in heart rate rhythm and pulse that may be caused by heart disease or other serious health problems 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 z Indicates the matters in which death or severe bodily A Warning damage may arise as a result of incorrect handling Cauti Indicates the matters in which bodily harm or material A aution damage may arise as a result of incorrect handling General Information Note Indicates general information t
27. ositive negative polarity Do not insert batteries with their polarities reversed Do not connect the positive and negative terminals of the battery with a wire or other metal object Do not use the AC adapter and battery at the same time AN Caution If battery fluid comes in contact with skin or clothing rinse immediately with water Do not use new and old batteries together or use different types of batteries together Non Invasive Blood Pressure NIBP measurement A Warning If a cuff is used on a patient with an infection 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 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 AN Caution NIBP measurement should be perfo
28. ow the instructions of the doctor 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 lf the patient moves or the cuff is touched this may be falsely detected as a pulse and over inflation will occur e Do not inflate the cuff when it is not wrapped on the upper arm This may damage the cuff 16 Zero indicator function Before each measurement this device indicates that zero calibration was successful E When the power is turned on zero calibration starts after the entire indicator blinks When completed QK appears ANEN E When the power is already on zero calibration takes place from the ready screen which shows 0 When completed OK appears 17 Non Invasive Blood Pressure NIBP Measurement Measurement in normal 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 ran
29. power for 25 cycles mains interruptions it is recommended that the HBP 1100 be powered Ur Rated voltage of lt 5 Ur lt 5 Ur from an uninterruptible test unit for 5 sec for 5 sec power supply or batteries Power frequency Power frequency magnetic fields should 50 60 Hz 3 Al ZA pe at levels PEE magnetic field m r m s m r m s characteristic of a typica IEC 61000 4 8 location in a typical commercial or hospital environment Note Uy is the a c mains voltage prior o application of the test level 37 Immunity test IEC60601 1 2 IEC60601 1 2 test level test level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 3 Vrms MHz 80 AM 2Hz 3 Vrms 80 MHz to 2 5 3 V m GHz 80 AM 2Hz Portable and mobile RF communications equipment should be used no closer to any part of the HBP 1100 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommend separation distance d 1 2 d 1 2 80 MHz 800 MHz d 2 3 800 MHz 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to he transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic si
30. r Blood pressure may vary widely due to physiological effects The causes below are possible e Emotional excitement or agitation Pain due to cuff wrapping White coat hypertension e Cuff size or wrapping method not correct e 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 28 List of Error Codes E Example E2 E SYSTEM Z Error code Description Points to check e Sensor failure Contact your local OMRON E9 e EEPROM failure rabrecentalive e Switch error P i NIBP Error Description Points to check code The cuff tube is not connected Firmly connect the cuff tube E1 7 f Replace with an OMRON GS Air is leaking from the cuff CUFF that does not leak Did not inflate properly because Have the patient not move the the arm or body moved during arm or body and repeat measurement measurement Moved body or arm during Have the patient not talk or measurement or talked move and repeat measurement The cuff is not applied correctly Correctly apply the cuff The sleeve is rolled up andis Remove the garment and re E2 compressing the arm wrap the cuff Measurement time has exceeded specified time Specified time 165 seconds The measurement time exceeds the expected time so the measurement was ended in order to avoid patient disc
31. revent possible harm to the environment or human health from uncontrolled waste disposal please separate this product from other types of wastes and recycle it responsibly to Si 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 take this item for environmentally safe recycling Business users should contact their supplier and check the terms and conditions of the purchase contract This product should not be mixed with other commercial wastes for disposal This product does not contain any hazardous substances Disposal of used batteries should be carried out in accordance with the national regulations for the disposal of batteries 35 Manufacturer s Declaration The HBP 1100 is intended for use in the electromagnetic environment specified below The customer or the user of the HBP 1100 should assure that it is used in such an environment Electromagnetic Emissions IEC60601 1 2 Emission Test Compliance Electromagnetic Environment The HBP 1100 uses RF energy only for internal functions Therefore this RF emission BE emission Group 1 is extremely weak and there is little chance of it creating any kind of interference whatsoever with nearby electronic equipment RF emissions Class B CISPR 11 The HBP 1100 is suitable for use in all 7
32. reviewed the contents of this Instruction Manual However if an inadequate description or error is found please let us know 3 It is prohibited to copy a part of or the entire Instruction Manual without getting OMRON s permission Unless this Instruction Manual is used by an individual company it cannot be used without getting OMRON s permission from the standpoint of the Copyright Law Table of Contents Introduction Intended Wse wninshans aia tien aceite cee ile ietasaias Features of the Product Notes on Safety cece coe i aed un oe ween Using the Unit Components of the ProduCt c ccccecceeeeeeeeeeeeeeeeeeaeeetenteeeeeaes 10 Features Functions of Unit 0 ccccscceeeeeeeeeneeeeeeeeeseeeeeeeeeeess 11 Installing the Batteries cccceccceceeeeeeeeeeeeeeeeeeeeeeeeteeeeeteneeeeees Connecting the AC Adapter a Cuff Selection and Connection cccceeeeceeeeeeeeeeeeteeeeeeteeeteeaes 14 Applying the Cuff to the Patient cccccceceeeeeeeeeeeeeeeeteeeeeeee 15 Zero indicator FUNCTION ccceeeeeeeeeeeeeeeeeteeeeeseeeeeeeeeeeeesaeeeeees 17 Non Invasive Blood Pressure NIBP Measurement Measurement in normal MOC cccseeceeeeeeeeeeeteeeeteteeeeeneeees Measurement in auscultation mode 28 Stopping the Measurement c ccceeeeeeeeeeeeeeeeeeeteneeeeteneeeteaees Non Invasive Pressure Measurement Principles 00 22
33. rmed 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 measurement 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 eart A difference of 10 cm 4 inches 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 an OMRON GS CUFF can be used with this device The use of any other cuff may result in incorrect measurem
34. te 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 o Note1 At 80 MHz and 800 MHz tl he 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 1100 is used exceeds the applicable RF compliance level above the HBP 1100 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the HBP 1100 Over the frequency range 150 kHz to 80MHz field strengths should be less than 3 V m 38 Recommended Separation Distances Recommended separation distance between portable and mobile RF communications equipment and the HBP 1100 The HBP 1100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The c
35. ustomer or the user of the HBP 1100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the HBP 1100 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output powerof 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 transmitter W d 12 MHz GHz d 1 2 d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 i 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 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 39 Optional Accessories Optional Medical Accessories 40 AC adapter GS CUFF XL GS CUFF L GS CUFF M 60240HW5SSW HXA GCUFF HXA GCUFF HXA GCUFF XLLB LLB MLB GS CUFF S GS CUFF SS Instruction HXA GCUFF H
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