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10.

Optional Items (requiring order)

Cuffs

Name

Description

Order code

Small cuff

for left arm

Arm circumference
15 to 22 cm

5.9" to 8.7"

TM-CF202B

Adult cuff

for left arm

Arm circumference
20 to 31 cm

7.8" to 12.2" TM-CF302B

Large cuff

for left arm

Arm circumference

28 to 38 cm

11.0" to 15.0" TM-CF402B

Extra-large cuff

for left arm

Arm circumference
36 to 50 cm

14.2" to 19.7" TM-CF502B

Adult cuff

for right arm

Arm circumference
20 to 31 cm

7.8" to 12.2" TM-CF802B

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 cuff cloth

for left arm

2 sheets

AX-133024487-S

Large cuff cloth

for left arm

2 sheets

AX-133025102-S

Extra-large cloth

for left arm

2 sheets

AX-133025103-S

Adult cuff cloth

for right arm 2 sheets

AX-133025104-S

Air hose adaptor

TM-CT200-110A

Содержание TM-2441

Страница 1: ...Recorder for Ambulatory Blood Pressure Monitor Ambulatory Blood Pressure Monitor 1WMPD4003500H 2201 English Original...

Страница 2: ...en permission of A D Company Limited The contents of this manual and the specifications for the instrument covered by this manual are subject to change for improvement without notice The Bluetooth wor...

Страница 3: ...rt 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interfere...

Страница 4: ...equipment has very low levels of RF energy that are deemed to comply without testing the specific absorption ratio SAR Compliance with the Australian EMD Framework The device conforms to the following...

Страница 5: ...actice 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 s...

Страница 6: ...flammable gases are present high pressure oxygen chambers and oxygen tents Using the recorder in these areas may cause an explosion Do not use the recorder together with a magnetic resonance imaging...

Страница 7: ...ected safely Check for mutual interference with other medical devices Confirm that the recorder can be used correctly Use accessories options and consumables specified by A D Carefully read the instru...

Страница 8: ...em occurs Take care when using around babies and infants as there is a danger of accidental suffocation with the air hose 3 Precautions for Batteries Used for Blood Pressure Measurement Install the ba...

Страница 9: ...ion of the body or arms when operating the vehicle etc This medical device can be only operated by a doctor or a legally authorized person Explain the correct usage to the patient and ensure they can...

Страница 10: ...the AUTO switch to OFF If you leave the AUTO switch at ON pressurization for automatic measurement is started at the next measurement start time and the cuff or other parts may be broken by the infla...

Страница 11: ...the Life of the Backup Battery When first using after purchase or after storing for a month or more replace the batteries and charge the backup battery It is enough if the backup battery is charged fo...

Страница 12: ...7 Precautions for Maintenance Confirm the correct performance and safety of the recorder when it has not been used for a long period of time To maintain correct measurement and safety perform an insp...

Страница 13: ...tooth connection within the range of a wireless LAN or other wireless devices near devices that emit radio waves such as microwaves in locations where there are many obstructions or in other locations...

Страница 14: ...the room Use close to an IEEE802 11g b n wireless LAN device may cause mutual interference to occur which may result in reduced communication speeds or prevent connection In this case switch off the p...

Страница 15: ...ease on an arm 2 An arm receiving an intravenous drip or blood transfusion 3 A limb that is shunted for artificial dialysis 4 The patient has been bedridden for a long time Where there is a possibilit...

Страница 16: ...eding is temporary and disappears with time If the patient uses a heart lung machine blood pressure cannot be measured due to the absence of a heartbeat Blood pressure cannot be measured correctly if...

Страница 17: ...omy Cuff Dispose of cuffs contaminated by blood to prevent infectious disease from spreading Avoid storing the cuff folded or with a tightly twisted air hose for extended periods of time Such treatmen...

Страница 18: ...s 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 cu...

Страница 19: ...cuff for left arm Blood pressure Recorder Large cuff for left arm Carry holder Clip Adult cuff cover Large cuff cover Belt Activity record sheet 10 sheets ABPM Data Manager CD USB cable This instruct...

Страница 20: ......

Страница 21: ...s iii Precautions for Use iv Precautions For Safe Measurement xiii Blood Pressure Measurement xiii Cuff xv Measurement of Pulse Rate xv Packing List xvi 1 Introduction 5 2 Features 5 3 Abbreviations S...

Страница 22: ...Pressure Measurement S BPM 31 6 2 1 S BPM Programs 32 6 2 2 S BPM Waiting Mode 36 6 2 3 Stopping and Suspending Measurement 37 6 3 Measurement Results 38 6 3 1 Displaying Measurement Results 38 6 3 2...

Страница 23: ...ters 59 8 4 2 S BPM Display Examples 60 8 5 Deleting Measurement Data 63 8 6 Attaching the Product to the Patient 64 8 6 1 Information for Patients 64 8 6 2 Cuff Cover 66 8 6 3 Attaching the Cuff Carr...

Страница 24: ...2 9 3 Periodic Inspection 84 9 3 1 Battery Pre installation Inspection 84 9 3 2 Battery Post installation Inspection 85 9 4 Disposal 86 9 5 Troubleshooting 87 9 6 Error Codes 88 10 Optional Items requ...

Страница 25: ...ifications and warnings Read this manual for proper use and keep it in an accessible place 2 Features Summary The recorder is an ambulatory blood pressure monitor that can non invasively measure the b...

Страница 26: ...M The use of this mode assumes that a patient measures their own blood pressure at home or in hospital This mode can use five types of programs in accordance depending on use Portability The weight of...

Страница 27: ...ms for varying conditions The analysis can be carried out effectively using the ABPM Data Manager installed on the computer dedicated peripheral Shorter measurement time The deflation speed is control...

Страница 28: ...ng Interval time of 1 scope is performed The IHB AFib indicator Mute Memory full delete data to start measurement Battery indicator If the level 1 is displayed blood pressure measurement and data comm...

Страница 29: ...2 to 19 7 Large cuff 28 38cm 11 15 Symbol printed on packing Large cuff is included in accessories Adult cuff 20 31cm 7 8 12 2 Symbol printed on packing The adult cuff is included in the accessories...

Страница 30: ...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 the rechargeable batteries specified and ensure correct...

Страница 31: ...isplay with the measurement values S BPM only 1 scope 1 scope in S BPM consists of a set of blood pressure measurements and interval times which are repeated for the number of the measurement count Th...

Страница 32: ...n which the ABPM Data Manager is installed The ABPM Data Manager is stored on an accessory CD Use a peripheral device that complies with the requirements for medical electrical equipment IEC60601 1 wh...

Страница 33: ...ic pressure 30 to 160 mmHg Pulse rate 30 to 200 beats minute Depressurization Constant exhaust with a controlled leakage valve for safety Exhaust Electromagnetic valve Pressurization method Micro pump...

Страница 34: ...nditions Rated voltage DC 3 0 V Alkaline battery LR6 DC 2 4 V Nickel hydrogen battery AAsize Interface USB USB1 1 compliant Cable length 1 5 m or shorter Micro USB B type terminal can connect to dedic...

Страница 35: ...ns Durability varies with usage conditions Ingress protection Device IP22 Default mode Continuous measurement Restart time after defibrillation Immediately EMD IEC 60601 1 2 2014 Wireless communicatio...

Страница 36: ...16 4 2 Dimensions 66 24 5 95 Unit mm...

Страница 37: ...START and STOP switch for A BPM LCD START and STOP switch for S BPM Battery compartment and 2 LR6 AAsize batteries for measurement Micro USB port at bottom Data communication terminal Artery position...

Страница 38: ...Upper figures Middle figures Lower figures The following values can be displayed in each mode Measurement Result A BPM S BPM Upper figures Systolic blood pressure Interval time Program Middle figures...

Страница 39: ...ssure 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 Symbols Meanin...

Страница 40: ...preset A BPM program OFF A BPM is suspended and the mark is hidden Blood pressure measurement can be performed using the preset S BPM programs To lock A BPM to ON Keep the AUTO switch to ON using the...

Страница 41: ...e pressing and holding the START STOP switch press and hold the EVENT switch until Sleep is displayed on the OLED Step 4 The operation switches are as follows Refer to 8 3 1 A BPM Items and Parameters...

Страница 42: ...rn to the waiting mode display Step 3 While pressing and holding the START STOP switch press and hold the EVENT switch until Display after Sleep is displayed on the OLED Step 4 Operation switches are...

Страница 43: ...start time or start time of alarm Automated self blood pressure ASBP To stop S BPM Operations are as follows S BPM Programs Operations Office blood pressure OBP Press the switch to stop blood pressur...

Страница 44: ...nual blood pressure measurement of S BPM Step 1 If the LCD is hidden press the START STOP or EVENT switch to return to the S BPM waiting mode display Step 2 Press the switch during the S BPM waiting m...

Страница 45: ...to the waiting mode display Step 3 While pressing and holding the START STOP switch press and hold the EVENT switch until DataClear after Sleep and Display is displayed on the OLED Step 4 Select an o...

Страница 46: ...ed on the LCD If you cancel the current pairing press the EVENT switch The recorder proceeds to the waiting mode display To suspend Bluetooth communication Airplane mode Step 1 Set the AUTO switch to...

Страница 47: ...O switch is left ON the measurement will start at the next start time and the cuff may burst Use the LOCK switch to prevent the AUTO switch from moving to OFF accidentally while A BPM is used AUTO swi...

Страница 48: ...surizations are performed automatically up to two times When you delete data from the memory or move the AUTO switch to OFF the pressurization value is reset to the initial pressurization value When a...

Страница 49: ...p Function and Interval time Set the sleep mode to ON in the preset program When the EVENT switch is pressed during A BPM the interval time doubles When the EVENT switch is pressed again in A BPM the...

Страница 50: ...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 and is stored in the memory 6 1 4 Storing Env...

Страница 51: ...time Count Interval HBP Home blood pressure 1 Program for blood pressure measurement at home 1 scope Measurement is performed using the measurement count and interval time Count Interval ANBP Automate...

Страница 52: ...scope consists of a set of blood pressure measurements and interval times which are repeated for the number of times of the measurement count The last interval time is omitted When the switch is pres...

Страница 53: ...mes which are repeated to the number of the measurement count The last interval time is omitted When the switch is pressed during the 1 scope the 1 scope is stopped T Interval time Press the switch to...

Страница 54: ...last interval time is omitted Note Manual blood pressure measurement of the ANBP When the switch is pressed in S BPM waiting mode a 1 scope is performed T Interval time 1 scope T Time T T T TheANBP i...

Страница 55: ...f the measurement count The last interval time is omitted Note Manual blood pressure measurement for theASBP When the switch is pressed in waiting mode between the last 1 scope and the next 1 scope Th...

Страница 56: ...esumes A 1 scope consists of a set of blood pressure measurements and interval times which are repeated up to the number of times of the measurement count The last interval time is omitted Clock mark...

Страница 57: ...d pressure measurement Automated office blood pressure AOBP Home blood pressure HBP Automated night blood pressure ANBP Press the switch to stop blood pressure measurement At the next start time blood...

Страница 58: ...efer to 8 2 2 The Clock and the Monitor Function of Measurement 6 3 2 Storing Measurement Results Data processing of the measurement result Do not use in a strong electromagnetic field The memory capa...

Страница 59: ...o not remove the cable while using USB communication It may cause damage to the data Note When the battery indicator displays data transfer cannot be used Replace the batteries to use data transfer 6...

Страница 60: ...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 sp...

Страница 61: ...n Push the spring terminal using the terminal of the battery Step 4 Insert the battery by pushing the terminal Step 5 Insert the second battery using the same method Step 6 Close the battery cover Kee...

Страница 62: ...eries are replaced Refer to 8 2 2 The Clock and the Monitor Function for Measurement to adjust the clock 7 2 PreparingtheCarryHolder Note When the carry holder is attached use the accessory belt We re...

Страница 63: ...ists No Item Description 1 Exterior No damage and deformation from dropping No damage and looseness of switches etc 2 Battery Check that the batteries are not flat Replace with two new batteries befor...

Страница 64: ...and strong smells Check that there is no strange sound 2 Display Check that there is no strange display 3 Operation Check that the recorder operates correctly 4 Measurement Check that the measurement...

Страница 65: ...ettings of the recorder can be stored using a dedicated peripheral Refer to the instruction manual for the ABPM Data Manager Measurement procedures forA BPM and S BPM are different A BPM can specify s...

Страница 66: ...and pressurization value Attach the recorder and cuff A BPM Attach the recorder and cuff A BPM Move the AUTO switch to OFF Office blood pressure OBP Automated office blood pressure AOBP Home blood pre...

Страница 67: ...s Start time for section 1 0 hours Interval time for section 1 30 minutes Start time for section 2 0 hours 1 Start time for the automated measurement OFF Operation time of the automated measurement OF...

Страница 68: ...te Automated self blood pressure ASBP Start time of alarm 7 hours 22 hours Measurement count 2 counts Interval time 1 minute The content of the factory settings When the switch is pressed after the AU...

Страница 69: ...T switch Change the current parameter START STOP switch Decision next item end of settings Then use these switches in another items Step 5 After configuring settings press the START STOP switch to ret...

Страница 70: ...ode display Step 3 Select a pressurization value using the START STOP switch 8 3 A BPMPresetPrograms The initial settings can be configured using the following methods Using the switches on the record...

Страница 71: ...he current parameter START STOP switch Decision next item Step 5 Specify the start time and interval in up to six sections using the following switches EVENT switch Change the current parameter START...

Страница 72: ...0minutes Section 3 Start time Hour 3 xx xx 0 to 23 hours Interval time Cycle 3 xx xx OFF 5 10 15 20 30 60 120minutes Section 4 Start time Hour 4 xx xx 0 to 23 hours Interval time Cycle 4 xx xx OFF 5 1...

Страница 73: ...If the AUTO switch is set to ON again the automated measurement starts at the preset start time Note When the operation time is specified even if the AUTO switch is operated during the automated measu...

Страница 74: ...or the automated measurement can be specified The interval time of sections 1 to 6 cannot be used Refer to 6 1 2 Sleep Function and Interval time Section 24 hours can be divided into six sections at m...

Страница 75: ...tart time of section 3 is the same as for section 1 When the start time for sections 2 3 4 5 or 6 is the same as for section 1 these start times and intervals are not displayed Example 1 Automatic mea...

Страница 76: ...nd to ON again during the automated measurement the automated measurement continues Example 3 Automatic measurement The start time for the automated measurement OFF The operation time for the automate...

Страница 77: ...start time of the automated measurement is specified and the AUTO switch is set to ON and the automated measurement is started the following message is displayed If the start time is earlier than the...

Страница 78: ...l is displayed on the LCD Step 3 Select S BPM program using the following switches Program OBP AOBP HBP ANBP ASBP switch Change the current parameter START STOP switch Decision next item Step 4 Specif...

Страница 79: ...ressure ANBP Start time 2 0 to 23 hours 1 Measurement count 2 1 to 5 counts Interval time 1 1 to 5 minutes Automated self blood pressure ASBP Start time of alarm 7 22 0 to 23 hours 2 Measurement count...

Страница 80: ...the measurement count and interval time AOBP performs a 1 scope after a waiting mode to relax Refer to 6 2 1 S BPM Programs for the 1 scope Measurement count Interval time Home blood pressure display...

Страница 81: ...or start time finish Next specify the measurement count and interval time for the 1 scope First start time 2nd start time 3rd start time Measurement count Interval time Example Settings and simplified...

Страница 82: ...me the settings for start time finish Next specify the measurement count and interval time for the 1 scope Measurement count Interval time Example Settings and simplified input The buzzer sounds at 22...

Страница 83: ...ot operate the device whlie the data is being deleted to ensure that it is deleted correctly Procedure of operation using switches Step 1 Set the AUTO switch to OFF Step 2 If the indication is hidden...

Страница 84: ...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 reco...

Страница 85: ...e measurement remove the cuff and consult a doctor Set the AUTO switch to OFF to suspend A BPM Set the AUTO switch to ON to resume A BPM automated measurement The mark is shown on the LCD and OLED The...

Страница 86: ...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 wrap around your neck at bedtime Replacing Batteries When the ma...

Страница 87: ...a measurement error Note Attach the cuff in the correct position and wrap around the arm to measureblood pressure correctly Prevent the cuff and air hose from vibrating during measurement The recorder...

Страница 88: ...at 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 r...

Страница 89: ...69 Air hose Air hose Cuff Belt Carry holder Air plug Air socket Insert Carry holder Belt Tape Clip...

Страница 90: ...O switch to OFF If the recorder is removed during A BPM the inflation of the cuff starts at the next start time and the cuff may burst When A BPM is resumed set the AUTO switch to ON The mark is displ...

Страница 91: ...dance with A BPM settings To measure blood pressure during A BPM immediately Manual blood pressure measurement of A BPM Step 1 If the OLED display is hidden press the START STOP or EVENT switch to ret...

Страница 92: ...insert the batteries and press the switch Manual blood pressure measurement can be performed during S BPM waiting mode The measurement result for the manual blood pressure measurement can be stored i...

Страница 93: ...or Suspend S BPM Operations are as follows S BPM Programs Operations Office blood pressure OBP Press the switch to stop blood pressure measurement Automated office blood pressure AOBP Home blood pres...

Страница 94: ...ED display is hidden press the START STOP or EVENT switch to return to theA BPM waiting mode display TheA BPM waiting mode is a state that blood pressure is not measured during the interval time Step...

Страница 95: ...splayed on the OLED and is stored in the memory To suspend A BPM Step 1 Set the AUTO switch to OFF Step 2 The mark is hidden A BPM is suspended To stop during A BPM When the START STOP switch is press...

Страница 96: ...ood pressure AOBP Home blood pressure HBP Automated night blood pressure ANBP Press the switch to stop blood pressure measurement At next start time blood pressure is measured or the buzzer sounds 1 I...

Страница 97: ...e failure and malfunction Confirm that the terminal cable is properly connected Blood pressure cannot be measured during USB communication Do not attach to the patient when the recorder is connected t...

Страница 98: ...mmunication with a dedicated peripheral Step 1 Connect the micro USB cable between the recorder and the dedicated peripheral Step 2 The buzzer sounds and is displayed on the LCD The data communication...

Страница 99: ...he first device will be unpaired If devices cannot communicate after pairing try pairing once again Bluetooth Pairing Step 1 Set the AUTO switch to OFF Step 2 If the display is hidden press the START...

Страница 100: ...p 2 If the display is hidden press the START STOP or EVENT switch to return to the waiting mode display Step 3 Press and hold the EVENT switch until FlightMode is displayed on the OLED Step 4 Airplane...

Страница 101: ...operator As a basic rule the operator should inspect this instrument daily such as by following the Inspection before use Daily management such as inspection before use is necessary to maintain the p...

Страница 102: ...n Do not use a hair dryer etc to dry the recorder It may cause malfunction and damage Confirmation after Cleaning the Cuff Confirm that the cuff bladder is correctly inserted inside the cuff cloth If...

Страница 103: ...ient name when disinfecting Example useable antiseptic solution Ingredient name Component Name Product Name Benzalkonium chloride Benzalkonium chloride 10 solution Isopropanol 70 in 1 propanol Ethanol...

Страница 104: ...ff it may cause peripheral dysfunction from stopping the blood flow in the arm The cuff bladder is correctly inserted inside the cuff cloth No fraying of the cuff The cuff doesn t ravel Replace the cu...

Страница 105: ...ls No strange sounds Operation No trouble with the functioning of switches and buttons Measurement Cuff Measurement values are close to the usual value No strange sounds or actions during measurement...

Страница 106: ...th a backup battery inside When disposing of the recorder dispose of the battery properly in accordance with the local regulations for environmental protection Others Name Part Material Package Case C...

Страница 107: ...d correctly Check the cuff and air hose for folding kinks and connection No USB communication 2 The communication cable is removed Confirm that the cable is connected correctly Communication response...

Страница 108: ...ressure exceeds 299 mmHg Body motion may occur during pressurization Relax and keep still during measurement If this does not help inspect the recorder Force stop using START STOP or switch Press the...

Страница 109: ...ion speed or exhaust speed is slow 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 dete...

Страница 110: ...s even when relaxed and not moving contact your dealer for inspection Hardware error codes on the recorder Code Meaning Cause and treatment Memory error It may happen in case of a strong impact such a...

Страница 111: ...to 12 2 TM CF802B 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 sh...

Страница 112: ...analysis Name Description Order code USB cable AX KOUSB4C Others Name Description Order code Activity record sheet 10 sheets AX PP181 S Carry holder AX 133025995 Belt AX 00U44189 Clips 5 pieces AX 11...

Страница 113: ...ssure is specified as the point where the amplitude reaches its maximum and the diastolic blood pressure is specified as the point where the amplitude decreases gradually Actually the pressure sensor...

Страница 114: ...at the same height as heart Wrap the cuff around 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 he...

Страница 115: ...iosclerosis or have abnormal arterial valves The wrong cuff size is a cause of differences between the direct method and oscillometric measurement method The cuff has the range of the arm circumferenc...

Страница 116: ...tion equipment e g cell phones can affect medical electrical equipment Accessories compliant with EMD standards The accessories and options for this recorder meet the conditions of IEC60601 1 2 2014 I...

Страница 117: ...frequency magnetic fields IEC 61000 4 8 30A m 50 Hz 60 Hz IMMUNITY TEST LEVELS PATIENT COUPLING Port Phenomenon Immunity test levels Electrostatic discharge IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV...

Страница 118: ...kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTEBand 13 17 Pulsemodulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM800 900 TETRA800 iDEN820 CDMA850 LTEBand 5 Pulsemodulation 18 Hz 2 0 3 28 870 930 1...

Страница 119: ......

Страница 120: ...ia 95131 U S A Telephone 1 408 263 5333 Fax 1 408 263 0119 A D AUSTRALASIA PTY LTD http www andmedical com au 32 Dew Street Thebarton South Australia 5031 AUSTRALIA Telephone 61 8 8301 8100 Fax 61 8 8...

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