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Compliance

Compliance with European Directive

The device conforms to Medical Devices Directive 93/42/EEC.

This is evidenced by the CE mark of conformity accompanied by the
reference number of a designated authority.

The device conforms to RoHS Directive 2011/65/EU.

Compliance with the Australian EMC Framework

The device conforms to the following requirements:

EMC Emission standard for industrial, Scientific & Medical equipment
AS/ NZS 2064:1997, EMC Generic Immunity standard AS/ NZS 4252.
1:1994. The above is evidenced by the C-Tick label.

Содержание TM-2440

Страница 1: ...Recorder for Ambulatory Blood Pressure Monitor Ambulatory Blood Pressure Monitor 1WMPD4003473B 1811 English Original 2440 2440 ...

Страница 2: ...r translated into any language in any form by any means without the written permission of A D Company Limited The contents of this manual and the specifications of the instrument covered by this manual are subject to change for improvement without notice Trademarks and trade names are those of their respective owners ...

Страница 3: ...by the reference number of a designated authority The device conforms to RoHS Directive 2011 65 EU Compliance with the Australian EMC Framework The device conforms to the following requirements EMC Emission standard for industrial Scientific Medical equipment AS NZS 2064 1997 EMC Generic Immunity standardAS NZS 4252 1 1994 The above is evidenced by the C Tick label ...

Страница 4: ...inst unsafe practice Symbol Examples The symbol indicates Caution The nature of the caution required is described inside or near the symbol using text or a picture The example indicates caution against electrical shock The symbol indicates Do not The prohibited action is described inside or near the symbol using text or a picture The example indicates Do not disassemble The symbol indicates Mandat...

Страница 5: ...sthetics or flammable gases are present high pressure oxygen chambers and oxygen tents Using the recorder in these areas may cause an explosion To preserve capabilities of the device consider the following environmental conditions when using and storing the recorder Performance of the recorder may be affected by excessive temperature humidity and altitude Avoid locations where the recorder may be ...

Страница 6: ...y Use accessories options and consumables specified byA D Carefully read the instruction manuals provided with optional items Cautions and warnings are not described in this manual For safe and correct use of the recorder perform inspections before use Leave the recorder one hour in normal operation condition before use and turn on it Connect only dedicated peripheral to the USB connector Do not c...

Страница 7: ...ance with polarity signs and shown on the inside of the battery cover Caution for polarities Replace consumed batteries to new ones at the same time Remove batteries if the recorder is not to be used for a long period of time The battery may leak and cause a malfunction Use two alkaline batteries sizeAA or specified re chargeable batteries sizeAA Ni MH Push and hold the spring terminal with the ba...

Страница 8: ...sure they can stop measurement when trouble occurs Do not use a mobile phone near the recorder It may cause a malfunction Stop the use of the recorder and suspend automatic blood pressure measurement if the patient feels pain in his arm or the measurement is incorrect Do not use the recorder in a strong magnetic or electric field Do not use the recorder on patient using a heart lung machine Note I...

Страница 9: ...if it is not used for a long period of time Batteries may leak and break the recorder Avoid using the recorder by a child oneself Do not put the recorder in a place within reach of an infant Doing so may cause accidents or damage Hold the connector housing when connecting and removing the cable Do not pull the cable Note Precautions After Using the Recorder TM 2440 Be sure to process measurement d...

Страница 10: ...ement and data communication cannot be performed Replace two newAAbatteries Remove batteries to prevent the recorder from liquid leakage of battery if the recorder is not used for a month or more 6 The Countermeasures When the Device Has an Error Stop the operation and removeAA batteries If battery terminals are shorted battery may be hot In a failure the cuff may get hot during measurement please...

Страница 11: ...Do not use volatile agents like a thinner benzine Do not use wet cloth Do not disassemble or modify the recorder medical electronic device It may cause damage 8 Precautions and Countermeasures of Malfunction Due to Strong Electromagnetic Wave The recorder complies with EMC standard IEC60601 1 2 2007 However to prevent electromagnetic interference with other devices do not use mobile phones near th...

Страница 12: ...pes of communication devices can affect the recorder Therefore they are necessary to keep a minimum distance of 33 m or more from the recorder If there is static electricity in the usage environment discharges from devices or the surrounding area Before using the recorder ensure that the operator and patient have discharged static electricity Humidify the room 9 Environmental Protection Before dis...

Страница 13: ...eiving an intravenous drip for blood transfusion This may cause an accident Do not wear the cuff above an external injury It may cause damage the wound or lead to infection Confirm the condition of the patient if there is measurement trouble It guesses that the condition worsens over the limit of measurement or the bending air hose is stopped air flow Measuring blood pressure too frequently may ca...

Страница 14: ...annot be measured due to absence of heartbeat Blood pressure cannot be measured correctly if thick cloth is worn Blood pressure cannot be measured correctly if the cloth is rolled up and arm is squeezed Blood pressure cannot be measured correctly if peripheral circulation is insufficient blood pressure is excessively low or if the patient has hypothermia blood flow is insufficient Blood pressure c...

Страница 15: ... the folded cuff or twisted air hose in a tightly for extended periods of time Such treatment may shorten the life of the components Measurement of Pulse Rate Do not use the displayed pulse rate for the diagnosis of the irregular heartbeat Note The recorder measures the pulse rate when measuring the blood pressure ...

Страница 16: ... on the packing list If you have any questions contact your local dealer or the nearest A D dealer We recommend keeping the special packing box Refer to 10 Optional Items requiring order for options Blood pressure recorder 1 Accessories Adult cuff 20 to 31 cm 7 8 to 12 2 for left arm TM CF302A 1 Adult cuff cover 2 Carrying holder AX 133025995 1 Belt AX 00U44189 1 Clip 1 Activity record sheet 10 sh...

Страница 17: ...xv Blood pressure Recorder Adult cuff for left arm Carrying holder Clip Adult cuff cover Belt Activity record sheet 10 sheets Analysis software CD USB cable This instruction manual ...

Страница 18: ......

Страница 19: ...easurement xi Cuff xiii Measurement of Pulse Rate xiii Packing List xiv 1 Introduction 4 2 Features 4 3 Abbreviations Symbols 6 4 Specifications 11 4 1 Recorder 11 4 2 Dimensions 14 5 Component Names 15 5 1 Recorder 15 5 2 OLED Display 16 5 3 Principal Switch Operations 17 5 3 1 A BPM Operations 17 5 3 2 Other Operations 20 ...

Страница 20: ... 27 7 Preparing the Recorder 28 7 1 Installing Batteries Replacing Batteries 28 7 1 1 How to Replace Batteries 30 7 2 Preparing the Carrying Holder 31 7 3 Inspection for Use 32 7 3 1 Battery Pre installation Checklists 32 7 3 2 Battery Post installation Checklists 33 8 Operations 33 8 1 Operation Flowchart 33 8 2 Initial Settings 35 8 2 1 Factory Settings 35 8 2 2 The Clock and the Monitor Functio...

Страница 21: ...ending Measurements 54 8 7 Connecting the Recorder to Dedicated Peripheral 55 8 7 1 Connecting with USB cable 55 9 Maintenance 57 9 1 Product Storage Inspection and Safety Management 57 9 2 Cleaning the Product 57 9 3 Periodic Inspection 59 9 3 1 Battery Pre installation Inspection 59 9 3 2 Battery Post installation Inspection 60 9 4 Disposal 61 9 5 Troubleshooting 62 9 6 Error Codes 63 10 Optiona...

Страница 22: ... is an ambulatory blood pressure monitor equipped for portability analytical performance and simple operation The recorder can measure and store blood pressure data of patients during their daily life Blood pressure measurement target This recorder is designed for adults above 12 years old Purpose of use The recorder enables automatic blood pressure measurement and manual blood pressure measuremen...

Страница 23: ...e configured easily using analysis software installed in the computer dedicated peripheral Extensive analytical performance Measurement interval time can be set for the automatic blood pressure measurement Blood pressure can be measured immediately using manual measurement anytime The analysis can be done effectively using analysis software installed in the computer dedicated peripheral Shorter me...

Страница 24: ...dicator When the level 1 is displayed replace batteries to use the recorder Symbol printed in the battery compartment Direction polarity to install battery Memory full Delete data to start the measurement A BPM sleep mark The mark is displayed during configuration SMALL Symbol for small cuff Arm circumference 15 to 22 cm 5 9 to 8 7 ADULT Symbol for adult cuff Arm circumference 20 to 31 cm 7 8 to 1...

Страница 25: ...erial number Alert mark Exx Error codes xx 00 to 99 OLED Organic light emitting diode EMC Electromagnetic compatibility Degree of protection against electric shocks Equipment type BF Manufacturer of the CE Marking Date of manufacture Refer to the instruction manual or booklet Symbol for Keep dry and Keep away from rain Symbol for Handle with care The symbol of waste electrical and electronic equip...

Страница 26: ...s and ensure correct polarity Do not mix new used or different branded batteries Firmly secure cuff air hose to main body Cautions on battery cover Use alkaline batteries or specified rechargeable batteries and ensure correct polarity Do not mix new used or different branded batteries Firmly secure cuff air hose to main body 1 Refer to 6 1 Automatic Blood Pressure Measurement A BPM and 8 3 A BPM P...

Страница 27: ...include body motion an increase in body temperature aging physiological properties and emotional changes I H B may be detected when a very slight vibration like trembling or shaking occurs Carry out analysis using a dedicated peripheral to know whether I H B has been detected or not Refer to the instruction manual of analysis software for details Pulse rate is faster 25 than average value or more ...

Страница 28: ...sured during the interval time T Interval time Dedicated peripheral Dedicated peripheral means the computer principally that analysis software is installed Analysis software is stored in accessory CD Time T T T T T Section Section Start time Start time Blood pressure measurement T T ...

Страница 29: ...280 mmHg Diastolic pressure 30 to 160 mmHg Pulse rate 30 to 200 beat minute Depressurization Constant exhaust with controlled leakage valve for safety mechanism Exhaust Electromagnetic valve Pressurization method Micro pump Automatic pressurization 85 to 299 mmHg Interval time ofA BPM Intervals at each section which divides 24 hours to six parts at the maximum Interval OFF 5 10 15 20 30 60 120 min...

Страница 30: ...ature 10 to 40 C Humidity 30 to 85 RH no condensation Transport and storage conditions Temperature 20 to 60 C Humidity 10 to 95 RH no condensation Atmospheric pressure both for operation and storage condition 700 to 1060 hPa Type of protection against electric shock Internally powered ME equipment Type of protection against electric shock Type BF The recorder cuff and tubing are designed to provid...

Страница 31: ...s measurement Restart time after defibrillation Immediately EMC IEC 60601 1 2 2007 Note Specifications are subject to change for improvement without prior notice Clinical trial for this device is performed in based on ISO 81060 2 2013 The recorder is not medical device for monitoring patient We don t recommend the way of use that has to monitor patient in real time at place like intensive care uni...

Страница 32: ...14 4 2 Dimensions 95 Unit mm 24 5 ...

Страница 33: ... Air plug Air socket EVENT switch OLED display START and STOP switch Battery compartment and 2 LR6 AAsize batteries for measurement Micro USB port at bottom Data communication terminal Artery position mark Adult cuff for left arm Battery cover ...

Страница 34: ...te of settings and operation The measurement value of A BPM SYS Systolic blood pressure DIA Diastolic blood pressure PUL Pulse rate mmHg Unit for blood pressure value min Unit for the pulse rate Refer to 3 Abbreviations Symbols for the meanings of symbols on the OLED display Symbols Meaning The mark is displayed during configuration Displaying A BPM is performing Memory full A BPM sleep mark Batte...

Страница 35: ... performed in accordance with preset A BPM program OFF A BPM is suspended and the mark turns off Manual blood pressure measurement can be performed by pressing the START switch though To expand A BPM interval time Step 1 Set the sleep mode to ON before the measurement Step 2 Start A BPM by pressing and holding the EVENT switch for 3 seconds or more The mark is shown Step 3 When the EVENT switch is...

Страница 36: ... suspendA BPM Step 3 While pressing and holding the START STOP switch press and hold the EVENT switch for 3 seconds or more Sleep is displayed on the OLED display Step 4 Operation switches are as follows Refer to 8 3 1 A BPM Items and Parameters EVENT switch Change the current parameter START STOP switch Decision next item end of settings To measure blood pressure during A BPM immediately Manual b...

Страница 37: ...ess and hold the EVENT switch for 3 seconds or more to suspendA BPM Step 3 While pressing and holding the START STOP switch press and hold the EVENT switch for 6 seconds or more Display is displayed on the OLED display Step 4 Operation switches are as follows Refer to 8 2 2 The Clock and the Monitor Function of Measurement EVENT switch Change the current parameter START STOP switch Decision next i...

Страница 38: ...n of the display is hidden press the START STOP or EVENT switch to return to the display of waiting mode Step 2 If the mark is shown press and hold the EVENT switch for 3 seconds or more to suspendA BPM Step 3 While holding the START STOP switch and hold the EVENT switch for 9 seconds or more DataClear is displayed on the OLED display Step 4 Press and hold the START STOP switch for 3 seconds Data ...

Страница 39: ...recorder and dedicated peripheral Step 2 The buzzer will sound and the following symbol appears on the OLED display The state of data communication enters standby mode Standby mode Step 3 Carry out analysis using the dedicated peripheral The state of data communication only enters active online mode during USB communication ...

Страница 40: ...blood pressure at preset intervals using the built in clock and stores the measurement result in the memory A BPM can be started and suspended by pressing and holding the EVENT switch 3 seconds or more The mark is displayed on the OLED display whileA BPM is used Blood pressure is measured automatically at theA BPM start time The initial pressurization value is set to 180 mmHg at the factory If the...

Страница 41: ... press and hold the EVENT switch for 3 seconds or more 6 1 1 A BPM Waiting Mode In the A BPM waiting mode the OLED display shows the current time together with the mark as follows In waiting mode the indicators are automatically hidden Press any switch to show items A BPM waiting mode is a state that blood pressure is not measured during the interval time Current time ...

Страница 42: ...the interval time doubles When the EVENT switch is pressed again in A BPM the interval time returns to original length Refer to 8 3 A BPM Preset Programs for information on how to set the sleep mode T Interval time Blood pressure measurement Start A BPM EVENT switch EVENT switch T T 2T 2T 2T T T Store parameters of the sleep mode Time ...

Страница 43: ...rement the air is exhausted immediately and the current measurement is stopped However A BPM is continued The next blood pressure measurement is performed in accordance with A BPM settings Note When measurement is stopped the stop code E07 is displayed on the OLED display and is stored in the memory ...

Страница 44: ... 8 2 2 The Clock and the Monitor Function of Measurement 6 2 2 Storing Measurement Results Data processing of the measurement result Do not use in a strong electromagnetic field The memory capacity for the measurement result is 600 data set When the memory is filled the mark is displayed and the recorder cannot perform measurement until data is deleted from the memory Note Delete data in the memor...

Страница 45: ... Connecting the Recorder to Dedicated Peripheral Note When the battery indicator displays data transfer cannot be used Replace batteries to use data transfer 6 2 4 ID numbers The factory default ID number is 1 Configure ID numbers using dedicated peripheral Note ID numbers cannot be configured with the recorder and require use of dedicated peripheral ...

Страница 46: ...attery compartment first push the spring terminal using the terminal of the battery Next insert the terminal If the battery is installed from the terminal the coating of the battery may be damaged by the spring terminal Do not mix and use different kinds of batteries or used batteries and new batteries It may cause a leak heating or damage Note When the level 1 of the battery level is displayed re...

Страница 47: ...ing the terminal Step 5 Insert the second battery using the same method Step 6 Close the battery cover Keep batteries and the battery cover away from infants and children with reach to prevent accidental swallowing or other accidents Use standard AA batteries Do not use an inflated battery rechargeable battery or one that wrapped in tape It may become difficult to open the cover Step 1 Open Step 6...

Страница 48: ...ameters are saved when batteries are removed When the built in battery runs out charge the date is reset to 01 01 2017 00 00 Check and adjust the current time when batteries are replaced Refer to 8 2 2 The Clock and the Monitor Function of Measurement to adjust the clock ...

Страница 49: ...hed use the accessory belt We recommend to use a belt to fit the recorder to the patient Use accessory carrying holder when the recorder is used To attach the carrying holder put the carrying holder through accessory belt or the belt of the clothes wearing Carrying holder Belt ...

Страница 50: ...o Item Description No damage and deformation due to drop 1 Exterior No damage and shaky fixation to switches and etc 2 Battery Check batteries not to be consumed Replace with two new batteries before the patient is used 3 Cuff Check that the cuff has not frayed If the cuff is frayed it may cause burst due to internal pressure Check that there are no kinks and folding of the air hose 4 Cuff connect...

Страница 51: ...ed correctly Attachment cuff measurement display and result are correct 8 Operations 8 1 Operation Flowchart Note The initial settings of the built in clock monitor function and initial pressurization value and preset program for A BPM do not need to be performed every time Perform the settings when the recorder is used for the first time when the settings have been lost or when the settings shoul...

Страница 52: ...ilt in clock measurement monitor function and pressurization value Attach the recorder and cuff A BPM For 24 hours A BPM SuspendA BPM by pressing and holding the EVENT switch for 3 seconds or more again Connect the recorder to dedicated peripheral Data processing Start A BPM by pressing and holding the EVENT switch for 3 seconds or more ...

Страница 53: ...me of the section 1 30 minutes Start time of the section 2 0 hour 1 Start time of the automated measurement OFF Operation time of the automated measurement OFF The content of the factory settings When the EVENT switch is pressed and held for 3 seconds or more A BPM is started Blood pressure is measured every 30 minutes until A BPM is suspended by pressing and holding the EVENT switch for 3 seconds...

Страница 54: ...hold the EVENT switch for 3 seconds or more to suspendA BPM The mark turns off Step 3 While holding the START STOP switch press and hold the EVENT switch for 6 seconds or more Display will display on the OLED display Step 4 Operation switches are as follows EVENT switch Change of the current parameter START STOP switch Decision next item end of settings Thereafter use these switches in another ite...

Страница 55: ...es on the recorder The method to use dedicated peripheral that is connected to the recorder using the USB cable A BPM can use only while the automated measurement can be performed Procedure of operation using switches Step 1 If the indication of the display is hidden press the START STOP or EVENT switch to return to the display of waiting mode Step 2 If the mark is shown press and hold the EVENT s...

Страница 56: ...witches EVENT switch Change of the current parameter START STOP switch Decision next item Step 6 Specify the start time and operation time of the automated measurement using the following switches EVENT switch Change of the current parameter START STOP switch Decision next item end of the settings Step 7 After completing settings the recorder returns to waiting mode Do not remove batteries while c...

Страница 57: ... 120minutes Start time Hour 3 xx xx 0 to 23 hour Section 3 Interval time Cycle 3 xx xx OFF 5 10 15 20 30 60 120minutes Start time Hour 4 xx xx 0 to 23 hour Section 4 Interval time Cycle 4 xx xx OFF 5 10 15 20 30 60 120minutes Start time Hour 5 xx xx 0 to 23 hour Section 5 Interval time Cycle 5 xx xx OFF 5 10 15 20 30 60 120minutes Start time Hour 6 xx xx 0 to 23 hour Section 6 Interval time Cycle ...

Страница 58: ...rement Start time Set to OFF Operation time Stores time to be continued 1 to 27 hours Response A BPM starts blood pressure measurement and stops after the Operation time The content of the item Sleep mode The Interval time for the automated measurement can be specified The Interval time of section 1 to 6 cannot use Refer to 6 1 2 Sleep Function and Interval time Section 24 hours can be separated t...

Страница 59: ...s the same as section 1 When the start time of section 2 3 4 5 or 6 is the same as section 1 these start times and intervals are not displayed Example 1 Automatic measurement The start time of the automated measurement OFF The operation time of the automated measurement OFF AfterA BPM is started blood pressure measurement is performed according to the start time and interval of each section until ...

Страница 60: ...it is suspended Example 3 Automatic measurement The start time of the automated measurement OFF The operation time of the automated measurement 26 hours After A BPM is started blood pressure measurement is performed according to the start time and interval of each section for 26 hours A BPM is started Blood pressure measurement Time Section 1 After 26 hours Section 2 Not measured A BPM is started ...

Страница 61: ...te data Keep no operation to delete data correctly Procedure of operation using switches Step 1 If the indication of the display is hidden press the START STOP or EVENT switch to return to the display of waiting mode Step 2 If the mark is shown press and hold the EVENT switch for 3 seconds or more to suspendA BPM The mark turns off Step 3 While holding the START STOP switch press and hold the EVEN...

Страница 62: ...e after pressurization Be quiet until measurement finishes The measurement process between inflating the cuff to releasing the air requires up to 170 seconds The recorder may re inflate to measure the blood pressure again after the end of pressurization This may be caused by body motion etc The recorder may start the blood pressure measurement after approximately 120 seconds when measurement data ...

Страница 63: ...stopped using the START STOP switch Press the START STOP switch to stop blood pressure measurement An error code is stored in the memory During A BPM only the current blood pressure measurement is stopped and measurement will be performed at the next start time When a pain of the arm or unexpected condition occur stop the measurement remove the cuff and consult the doctor Suspend A BPM by pressing...

Страница 64: ...s when wearing the recorder The recorder is precision instrument Do not drop or shock the recorder The recorder and cuff are not waterproof water resistant Prevent the product from contacting rain sweat and water Do not put anything on the product When the cuff is moved by excessive motion and exercise attach the cuff again Arrange the air hose so that kinks do not form and so that it does not wra...

Страница 65: ...7 8 5 2 Cuff Cover Note Keep the cuff and cuff cover clean Change the cuff cover for each person Use the cuff cover appropriate optional cuffs The cuff cover can be used to on the right arm and left arm ...

Страница 66: ...and measurement error Note Attach the cuff at the right position and wrap around the arm to measure the blood pressure correctly Prevent the cuff and air hose from vibrating during measurement The recorder measures delicate change of the air pressure inside the cuff The accessory cuff is an adult cuff for the left arm If cuff size does not fit purchase optional cuff Arm circumference Small cuff 15...

Страница 67: ...ainst the skin so that the white mark is directly over the brachial artery and the lower edge of the cuff is put on approximately 1 2 cm above the inside of the elbow Step 4 Wrap the cuff so that the ring is within the range it is flat and does not slip down but has room to insert two fingers Step 5 Fix the air hose using adhesive tape so as to pass over the shoulder Step 6 Pass the belt through t...

Страница 68: ...50 Step 5 Air hose Step 5 Tape Air hose Step 5 Clip Step 8 Air plug Step 8 Air socket Step 9 Insert Carrying holder Step 6 Belt Step 7 Carrying holder Step 7 Belt Step 5 Cuff ...

Страница 69: ...nds or more If the recorder is removed during A BPM the inflation of the cuff is started next start time the cuff may break To resume A BPM press and hold the EVENT switch for 3 seconds or more again The mark is displayed whileA BPM is activated Manual blood pressure measurement can be performed during A BPM waiting mode The measurement result of the manual blood pressure measurement can be stored...

Страница 70: ... in accordance with A BPM settings To measure blood pressure during A BPM immediately Manual blood pressure measurement of A BPM Step 1 If the indication of the OLED display is hidden press the START STOP or EVENT switch to return to the display of A BPM waiting mode A BPM waiting mode is a state that blood pressure is not measured during the interval time Step 2 Press the START STOP switch during...

Страница 71: ... measurement result is stored in the memory To measure blood pressure during A BPM immediately Manual blood pressure measurement of A BPM Step 1 If the indication of the OLED display is hidden press the START STOP or EVENT switch to return to the display of A BPM waiting mode A BPM waiting mode is a state that blood pressure is not measured during the interval time Step 2 Press the START STOP swit...

Страница 72: ...y and is stored in the memory To suspend A BPM Step 1 Press and hold the EVENT switch for 3 seconds or more Step 2 The mark is hidden A BPM is suspended To stop ongoing blood pressure measurement When the START STOP switch is pressed during blood pressure measurement the air is exhausted immediately and the current measurement is stopped However duringA BPM this function is not suspended The next ...

Страница 73: ...minal cable is properly connected Do not measure blood pressure while connecting a cable Cable may become wrapped around the body or neck Preparation of dedicated peripheral Remove the recorder and cuff from the patient before connecting the recorder TM 2440 to dedicated peripheral 1 We recommend to use the product that is complied with the IEC60601 1 2 2007 2 Use a USB cable shorter than 1 5 m 4 ...

Страница 74: ...he following symbol appears on the OLED display The state of data communication enters standby mode Step 3 Carry out analysis using the dedicated peripheral The state of data communication only enters active online mode during USB communication To stop data communication with dedicated peripheral Step 1 Remove the cable in the standby mode Standby mode Active online mode ...

Страница 75: ...n before use is necessary to maintain the performance safety and effectiveness of the recorder We recommend to a periodic inspection the recorder every year Note Medical institution must perform the maintenance management to ensure the safe use of the medical instrument 9 2 Cleaning the Product When cleaning the recorder do not splash water or submerge the device in water Do not use the autoclave ...

Страница 76: ...edicines etc using a cloth moistened with mild detergent Cleaning the cuff Do not squeeze the cuff and cuff cover when washing Submerge the cuff and cuff cover in a mild detergent and wash so that the cloth avoids damage Rinse with water Note The cuff and cuff cover are consumable goods When measurement error occurs frequently and measurement cannot be performed replace the cuff and cuff cover wit...

Страница 77: ...crack or adhesive matter in the connection between the cuff and cuff bladder If the air hose loses its flexibility and becomes hard When the surface of the air hose becomes glossy or feels oily When the air bladder has cracks 1 We recommend to replace cuffs every three years regardless of frequency of use The air hose is not to be folded If air remains in the cuff it may cause peripheral dysfuncti...

Страница 78: ...Exterior No strange sounds Operation No trouble with functioning of switches and buttons Measurement values are closely in usual value Measurement Cuff No strange sounds or actions during measurement Inspection of blood pressure value If blood pressure values are incorrect contact your local dealer ...

Страница 79: ... built in battery Remove and properly dispose of the lithium battery inside the recorder when the recorder is disposed Others Name Part Material Case Cardboard Cushion Air cushion special case Package Bag Vinyl Case ABS PC resin Internal parts General parts Chassis Iron Backup battery on the board Lithium rechargeable coin cell battery ML2016 Inside the recorder Battery Alkaline battery 1 5V LR6 o...

Страница 80: ...tteries No pressurization Cuff is not exactly connected Check the cuff and air hose concerning folding kink and connection No communication 2 Communication cable is removed Confirm the cable to be connected correctly Battery cover cannot be opened Non standard size batteries were used Contact your local dealer 1 Users unauthorized maintenance personnel cannot replace the backup battery lithium bat...

Страница 81: ...essure exceeds 299 mmHg Body motion may be occurred in the pressurization Relax and keep the silence during measurement If the treatment is not enough inspect the recorder Force stop using START STOP switch Press the START STOP switch only when necessary Blood pressure cannot be measured The heartbeat cannot be detected due to body motion or noise from clothes Relax and do not move Confirm the pos...

Страница 82: ...low an inspection is necessary Exhaust is above 90 seconds The exhaust speed may be slow an inspection is necessary Heartbeat cannot be detected Heartbeat cannot be detected because of body motion etc Measure the blood pressure while relaxed and do not moving The settings of the interval time are incorrect If the interval time is set to 120 minutes the difference between last start time and next s...

Страница 83: ... and do not move while the measurement If this error occurs even when relaxed and not moving contact your dealer for inspection Hardware error codes of the recorder Code Meaning Cause and treatment Memory error Malfunction of the built in memory Contact your dealer for inspection Note The error codes may be changed without any notice ...

Страница 84: ... 8 to 12 2 TM CF802A Disposable cuff 10 sheets TM CF306A Small cuff cover for left arm 10 sheets AX 133024667 S Adult cuff cover for left arm 10 sheets AX 133024500 S Large cuff cover for left arm 10 sheets AX 133024663 S Extra large cuff cover for left arm 10 sheets AX 133024503 S Adult cuff cover for right arm 10 sheets AX 133024353 S Small cuff cloth for left arm 2 sheets AX 133025101 S Adult c...

Страница 85: ...analysis Name Description Order code USB cable AX KOUSB4C Others Name Description Order code Activity record sheet 10 sheets AX PP181 S Carrying holder AX 133025995 Belt AX 00U44189 Clips 5 pieces AX 110B 20 S ...

Страница 86: ...is specified as the point where the amplitude reaches the highest the diastolic blood pressure is specified as the point where the amplitude decreases gradually and becomes small Actually the pressure sensor detects the subtle changes in the cuff pressure with time stores the pulse waveform in memory and evaluates the systolic and diastolic blood pressures according to the oscillometric measuremen...

Страница 87: ...r methods Cuff position at the same height as heart Wrap the cuff on the arm at the same level as the heart If the cuff position is incorrect a measurement error occurs For example if the cuff is 10 cm lower than the heart level the blood pressure is measured 7 mmHg higher Cuff pressure Left arm Direct method Left arm Cuff pressure Left arm Systolic blood pressure Average blood pressure Diastolic ...

Страница 88: ...easurement is guaranteed by the pressure accuracy of the pressure sensor exhaust characteristics and measurement algorithm so long as the proper cuff and air hose are used Inspect the pressure accuracy of the pressure sensor and exhaust characteristics periodically 11 2 EMC Information The requirements that apply to medical electronic instruments are described below Performance concerning of the E...

Страница 89: ...romagnetic environment RF emissions CISPR11 Group 1 The recorder uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR11 Class B Harmonic emissions IEC61000 3 2 N A Voltage fluctuations flicker emissions IEC61000 3 3 N A The recorder is suitable for use in all establishmen...

Страница 90: ...rical fast transient burst IEC61000 4 4 2 kV for power supply lines 1 kV for input output lines N A Surge IEC61000 4 5 1 kV differential mode 2 kV common mode N A Does not apply because the built in power supply unit is built in Power frequency 50 60 Hz magnetic field IEC61000 4 8 3A m 30A m Power frequency magnetic fields should become at levels characteristic of a typical location in a typical c...

Страница 91: ... 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycle 70 UT 30 dip in UT for 25 cycle 5 UT 95 dip in UT for 5 seconds N A Does not apply because the power supply unit is built in Note UT is theAC mains voltage prior to application of the test level ...

Страница 92: ...E2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the...

Страница 93: ...s equipment Rated maximum output power of transmitter W Recommended separation distance d according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m ...

Страница 94: ...76 MEMO ...

Страница 95: ......

Страница 96: ...arton South Australia 5031 AUSTRALIA Telephone 61 8 8301 8100 Fax 61 8 8352 7409 OOO A D RUS OOO ЭЙ энд ДИ РУС 121357 Российская Федерация г Москва ул Верейская дом 17 Business Center Vereyskaya Plaza 2 121357 Russian Federation Moscow Vereyskaya Street 17 http www and rus ru тел 7 495 937 33 44 факс 7 495 937 55 66 A D Technology Trading Shanghai Co Ltd 爱安德技研贸易上海有限公司 http www aanddtech cn 中国上海...

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