Recorder for Ambulatory blood pressure monitor INSTRUCTION
Contents
1. 31 Cuffs and Other Accessories 32 Maintenance Checking Accuracy 33 Cleaning the Cuff and Recorder 34 Periodical inspection 34 Problem Solving 34 Error Codes n nnn nnn nn nnn nnn nnn nnn nnn nnn nnn nnn nnn nnn nnn nnn nn mnenennmanmnnnn 35 INACX 37 Y compliance uaaa Compliance with European Directive 93 42 EEC for Medical Products The device conforms to the following requirements European Directive 93 42 EEC for Medical Products Medical Products Act European Standards for Electrical Medical Equipment EN60601 1 General Safety Provisions EN60601 2 30 Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment EN60601 1 2 and EN55011 Electromagnetic Compatibility European Standards pertaining to Non Invasive Blood Pressure Instruments EN1060 1 General Requirements EN1060 3 Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems The above is evidenced by2. Example Pass the belt to the ring Step 5 Thread the belt through the front hole and the rear hole of the hook Insert the belt to the ring again Insert the band to the buckle Pass the belt to the ring Thread the belt through the buckle like right illustration Page 26 C3 Automatic Measurement Caution L Automatic measurement uses the internal clock and parameters of automatic measurement Refer to section Parameters for the Display and Clock and Selection for the automatic measurement for setting these parameters L Press and hold the AUTO ON OFF key for approx 3 seconds so as to turn off A sign when the patient stops the automatic measurement or detaches the cuff If A sign is leaved when the next automatic measurement starts it damages the cuff Starting or re starting automatic measurement Step 1 Confirm the parameters for automatic measurement Refer to Selection for the automatic measurement Step 2 Press and hold the AUTO ON OFF key for about 3 seconds Then the A is displayed and the recorder starts an automatic measurement based on the internal clock and the parameters for automatic measurement Operation using mode Il Step 1 Press the AUTO ON OFF key turning off the S when the patient wakes up Step 2 Press the
3. 12 stop of a measurement _ 10 Storage 5 storage environment _ 12 SYS 2 systolic 8 Systolic Blood Pressure 2 T Transmission 28 V velcro 24 W weight 12 X X parameter 12 Y yellow mark 7 25 Page 38 MEMO Page 39 MEMO Page 40
4. 31 32 low battery 8 Page 37 M M ww nnn nn anna nn nn nana nnn nanan 8 10 management _ 9 manual measurement 9 Measurement 11 memory 10 11 mode 18 mode I 18 27 mode I 18 19 N Ni Cd 5 11 O operating environment 12 P Po aeee 29 parity 12 patient 23 portability 9 power switch 7 printer 28 pulse 8 R recorder 6 23 recordering sheet 32 Repair 3 reset key 7 22 right arm 31 INQ 24 RS 232C _ 7 12 28 S Sa n 8 18 selecting mode 18 Shoulder band 6 7 sleep 8 slit 25 small cuff 31 32 SN nennnnnnnn nnn enn nnn nen nnn en nn nenene 8 START STOP key _ 7 start time 2 18 19 20 stop bits _
5. 15 The State of Turning on the Recorder 16 Parameters for the Display and Clock 16 Selection for the Automatic Measurement 18 Deleting Old Data 22 Resetting the Recorder 22 Preparing the patient Patient Instructions 23 Use of the Cuff Cover 24 Attaching the Cuff and Recorder 24 Preparation of the Carrying Case _ 26 Operation Automatic Measurement by Programed Time Intervals 27 Manual Measurement 27 To Stop a Current Measurement 27 Data transfer Data Transmission to a Printer 28 Data Transmission to a Computer Using Analysis Software 30 Options and accessories Analysis Software and Communication Cables
6. When the automatic measurement sequence is finished turned off A sign Refer to Automatic Measurement Detach the cuff and recorder from the patient Transfer the patient s data and save it to other media Refer to Data transfer Clean the cuff and recorder and place in storage Refer to the sections Before use and Maintenance Page 14 Step 8 Step 9 Step 10 Step 11 Step 12 Step 13 Step 14 Step 15 Step 16 End Initializing the recorder W Replacing Batteries Caution L When B is displayed before a measurement the recorder can not make a measurement Please replace the new batteries before using O If B is displayed during the measurement stop the measurement and replace the new batteries at once O Use alkaline batteries or the specified rechargeable batteries for the recorder O Do not use new and used batteries at the same time Steps for replacing the batteries Step 1 Open the battery cover Step 2 Turn off the power switch Step 3 Replace with new batteries note the direction and Step 4 Turn on the power switch Step 5 Close the battery cover Battery cover Step 1 Step 5 Power switch Used batteries Page 15 C3 The State of Turning on the Recorder There are three types of state when the recorder is turned on
7. AUTO ON OFF i I Li START STOP cm Adl 7 START STOP c l Pa y gt Cc o re lt O 9 ma a y 4 3S A o n Ho oO v y gt fon o O O O Q ma START STOP ri Lt Lt AUTO ON OFF Do n T tt START STOP J ri 1 LI e AUTO ON OFF mo I i co pt START STOP e er a W Selection for the Automatic Measurement This setting initializes measurement intervals that is based on the internal 24 hour clock Mode mode 07 00 21 59 The measurement is performed every quarter hour 22 00 06 59 The measurement is performed every half hour mode II The AUTO ON OFF key is pressed at rising and going to bed so that the measurement intervals are changed and the time during sleep can be distinguished on the data When the S is off the measurement is performed every quarter hour When the S is displayed the measurement is performed every half hour mode Ill The measurement interval can change six times within a maximum of 24 hours The recorder can store six measurement intervals blocks in 24 hours A block consists of a start time and frequency Display amp key Mode m Selecting a mode 37 RO Ae Sign of setting parameters Saving a mode for automatic measurement Steps for selecting a mode ex Mode II is sel
8. Step 4 Wrap the cuff so that the ring is within the slide range it is flat and does not slip down but has room to insert two fingers If the ring is not within the slide range you need a proper cuff Step 5 Position the air hose over the shoulder and affix it on the patient using adhesive tape Step 6 Assemble the belt and carrying case Step 7 Position the belt so that the carrying case is on the right left side of the patient when a patient attaches left right arm cuff Step 8 Connect the air hose plug to the air socket Step 9 Place the recorder into the carrying case Caution Do not disturb the cuff or air hose during the measurement because the recorder measures small pressure variations Ring Yellow mark Appox 3 cm Sof Air hose plug Approx 1in 2ins Air socket _A Main body Sy Carrying case o ISL Page 25 W Preparation of the Carrying Case m O Use the belt or shoulder band to attach the carrying case We recommend the belt so that the carrying case is not worn out of shape on the patient Using the Belt Step 1 Step 2 Step 5 Using the Shoulder Band Step 1 Step 2 Step 3 Insert the belt to the hole of the Carrying case carrying case Pull the belt from the hole of the carrying case
9. 72 W x 100 D x 27 H mm 2 8 W x 3 9 D x 1 0 H in Weight Approx 215 g 0 47Ib excluding cuff TO lt 72 SUP AY mM i oes 100 S E _ 7 oul a UNIT mm Page 12 v Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 The complete procedure for use A Step by Step Procedure Battery replacement Replace with new alkaline batteries note direction Refer to page 14 Replacing Batteries Turn on the recorder using the power switch Step 2 With the recorder turned on select any operation to set the lt Step 3 gt state Case 1 Normal state The buzzer is sounded once and the clock is displayed You can use this recorder at once The recorder stores parameters for display and clock and automatic measurement Please proceed to Step 5 Case 2_ Error state When the recorder displays the tii error code it is necessary to set up parameters for display and clock and automatic measurement Please proceed to the next step Set up parameters for display and clock When you use automatic measurement set up parameters for automatic measurement Refer to Parameters for the Display and Clock and
10. E S gt F wh A amp D Company Limited 1WMPD4000136A Note This manual and or the TM 2430 may be changed at any time to improve the product without notice Before use Compliance nnn nnn nnn nnn nnn nnn nn nnn enema nnn nnn nn nnn nnn nnnnnnnnnnnnnan 2 Definitions nn newman nnn nnn nnn nn nn rene nn nnn nn nn en nn nnnn nnn nnnanmnns 2 Precautions for Use 3 Notes on the Blood Pressure Recorder 5 Welcome Welcome and Intention mmm 6 Product overview Packing List and Component Names 6 Display 8 Symbols 8 Specifications Features 9 Functions and Specifications 9 The complete procedure for use Step by Step Procedure 13 Initializing the recorder Replacing Batteries
11. Select a operation Refer to the section The complete procedure for use about use Action when the State of recorder Treatment recorder is turned on Operation The buzzer sounds The recorder storage You can use the recorder once and the clock is parameters of display at once displayed Normal and clock and automatic state measurement The buzzer is sounded Set up parameters of once and i is All parameters are lost display and clock and displayed blinking Automatic measurement The buzzer sounds The state after reset All four times and Li is parameters are lost displayed blinking CJ Parameters for the Display and Clock This setting selects the display during automatic measurement sequence and adjusts the clock parameters The sequence number tells you which parameter you are adjusting Display amp key Sequence number Selecting a sequence roo number 5 97 soL onor Parameter _ f L Selecting a parameter Sign of setting up parameters for display and clock Items Sequence Value amp Meaning of parameters number range 0 Displaying clock only in automatic measurement 1 1 Displaying pressure and result in automatic i e measurement 5 00 99 Years 1997 2096 iin 6 01 12 Month G in 7 01 31 Day ar 8 00 23 Hour Ht 9 00 59 Minute J uue Page 16 Steps for setting the display a
12. cuff sleeve for right arm 2 sleeves AX 133003461 S Cuff cover Name Order code Large cuff cover 10 sheets AX 133002066 S Adult cuff cover 10 sheets AX 133002018 S Small cuff cover 10 sheets AX 13A37410 S Others Name Order code TM 2430 Accuracy Diagnostic Kit TM2430 90 Recording sheet 10 sheets AX PP155 S Carrying case AX 003001955 Page 32 CJ Checking Accuracy Required equipment E U U Accurate office mercury sohygmomanometer or aneroid gauge with inflation system TM 2430 Accuracy Diagnostic Kit TM2430 90 A rigid cylinder sized to fit the cuff pressured Steps for checking accuracy Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Power switch TM 2430 Accuracy Diagnostic Kit Turn off the TM 2430 and remove the air hose from the unit Construct the check system as this drawing Mercury sphyg momanometer Keep the pressure at the air socket to atmospheric pressure Turn on the power switch when you press and hold the START STOP key The TM 2430 blinks the 0 of measurement value Squeeze the inflator bulb until cuff pressure reaches to 50 mmHg Check the difference between the blinking display of TM 2430 and mercury sphygmomanometer that is within 3 mmHg Squeeze the inflator bulb until cuff pressure reaches to 150 mmHg Check this difference t
13. deleted Page 7 Display Sleep sign ne ign AS py mem iy P SYS INTERVAL ie ee Bm mi u a H PULSE TIME P pa SYS mb grate Full memory sign Sign Oe Roe A nerva Setup sign of D Diastolic Blood an automatic measurement Ltt Pressure display Setup sign of er a l TIME a a clock om H pl PG display Error displ E i the clock ose Clock display Sign Name Functions Arrow The arrow points to the kind of current display in the measurement result and function mode Automatic A is displayed when the automatic measurement is selected A measurement When you press and hold the AUTO ON OFF key this sign is turned on or off alternately Sleep When you press the key while in mode II of the S automatic measurement S is displayed or turned off alternately With the S turned off the time interval is 15 minutes With the S turned on the time interval is 30 minutes Low battery When the recorder can not operate all functions due to low battery B this sign is displayed The clock is still displayed Please replace the batteries at once Full memory When data memory is at full capacity this sign is displayed In this M case you can not perform another measurement Transfer the data save in other media and delete Then the M turns off Y Symbols Turning on the recorder Turning off the recorder Direction guide to install batteries Di
14. key turning on the S when the patient goes to bed Stopping or canceling automatic measurement Step 1 Press and hold the AUTO ON OFF key for about 3 seconds A is not displayed and the recorder stops automatic measurement W Manual Measurement Step 1 Press the START STOP key The recorder starts a measurement at once The results are displayed and stored in memory iv To stop a Current Measurement Step 1 Press the START STOP key during measurement The recorder will stop the measurement at once and releases the air from the cuff Page 27 Data Transfer L The recorder transfers data to a printer or computer using the RS 232C terminal We recommend analysis of the data using the optional analysis software Caution L Cap the RS 232C terminal to prevent dust and foreign matter from entering when this terminal is not in use L Remove the recorder and cuff from the patient when the recorder is connected to a printer or computer Data Transmission to a Printer Caution CO The recorder intensely consumes the battery power while connected to the RS 232C cable Disconnect the cable when not actually transferring data Q Maintain the power on state while transmitting the data so that the data is not damaged L The optional RS 232C cable is required when connecting to a printer O The printer to print the data must have a serial inter f
15. the CE mark of conformity accompanied by the reference number of a designated authority This device is designed for adults only Compliance with FCC Rules Please note that this equipment generates uses and can radiate radio frequency energy This equipment has been tested and has been found to comply with the limits of a Class A computing device pursuant to Subpart J of Part 15 of FCC rules These rules are designed to provide reasonable protection against interference when this equipment is operated in a commercial environment If this unit is operated in a residential area it might cause some interference and under these circumstances the user would be required to take at his own expense whatever measures are necessary to eliminate the interference FCC Federal Communications Commission in the U S A Compliance with the Australian EMC Framework The device conforms to the following requirements EMC Emission standard for industrial Scientific amp Medical equipment AS NZS 2064 1997 EMC Generic Immunity standard AS NZS 4252 1 1994 The above is evidenced by the C Tick label Definitions SYS Systolic Blood Pressure DIA Diastolic Blood Pressure DSD The Difference between Systolic Blood Pressure and Diastolic Blood Pressure Exhaust This means releasing the cuff air as soon as possible Constant exhaust This means releasing the cuff air in a constant depressurization rate Exhaust velocity This means the rate of depressurizing t
16. the START STOP key once more until the buzzer becomes silent W Resetting the Recorder If the recorder does not work correctly press the reset key The recorder deletes all data and parameters The internal system is initialized Caution All data and parameters are deleted and preset initial parameters by the reset Do not press the reset switch to intensely Press this key gently so as not to damage the components inside Keep foreign matter away from the reset switch hole Steps for reset Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Reset key Open the battery cover Turn off the power switch Remove the batteries from the recorder Press the reset key gently Place new batteries in the recorder Turn on the power switch The recorder sounds the buzzer four times and Fil is displayed blinking Set the parameters for the display and clock Also adjust the parameters for automatic measurement Page 22 Preparing the patient C3 Patient instructions Advise the patient on how to cope with mis operation and contingencies Cautions during automatic measurement E Relax and be quiet when the recorder starts inflating the cuff Check the patient s blood pressure in the same posture as the measurement Minimize noise and movement for the measurements The recorder measures the pa
17. the retry is saved The recorder automatically adjusts the proper pressure exhaust velocity and end of measurement Refer to Selection for the automatic measurement and Automatic measurement by programed time intervals about operation and entering parameters Stopping a measurement O If you press the key during a measurement the recorder exhausts the air and stops the measurement Concealing the measurement value This function works only while using automatic measurement This function does not display the SYS DIA or pulse rate for the automatic measurement but the data is saved in memory This function can select reveal or conceal at Parameters for the display and clock Refer to this section If you select conceal the recorder displays the clock during a measurement If you reset the recorder this parameter is set to reveal Pressurization The pressure is automatically selected by the recorder while in the automatic measurement mode The first pressure is set to approx 185 mmHg This value automatically varies to the proper value after first measurement If the first inflation is not successful the recorder retries twice If you reset the recorder the first inflation value is set to 185 mmHg Memory The recorder can store 300 sets of data the memory capacity is 300 A data set consists of a SYS a DIA and a pulse rat
18. 7 7 43 103 65 55 97 5 17 8 00 119 79 65 97 5 17 8 30 125 88 132 97 5 17 9 00 122 84 116 97 5 17 9 30 115 87 63 cJ Data Transmission to a Computer Using Analysis Software Caution Steps for data transmission H i Step 1 Step 2 Step 3 The recorder intensely consumes the battery power while connected to the RS 232C cable Disconnect the cable when not actually transferring data Maintain the power on state while transmitting the data so that the data is not damaged Connect the cable to both the recorder and printer The Connection recorder displays _ Refer to Analysis Software m and Communication Cable about the cable Read the data using the optional analysis software Reading data Refer to the software instruction manual with software Remove the cable at once The clock is displayed Remove the cable Page 30 Options and accessories CJ Analysis Software and Communication Cables The analysis software has functions as follows LI Maximum value minimum value and average is calculated in an arbitrary period of time Partial analysis LI Correlation graph trend graphis and histogram is displayed LI The patient s data and information is managed L Data can be saved LQ Itis able to delete and copy a data LI A saved data file can export to CSV format that EXECL able to open LI D
19. E31 is greater than 60 an error code is displayed slow constant exhaust seconds E32 Clock error An error code is displayed If you not clear this error the product needs repair Pressure offset error to An error code is displayed at Release the air from the cuff E50 measure pulsation restarting the product com pletely reset the product If you not clear this error repair is necessary E52 Memory error An error code is displayed at The product needs repair restarting the product Battery contact is The measurement is stopped air Replace batteries correctly If you E53 defective is released from the cuff and an can not clear this error the error code is displayed product needs repair E55 Exhaust error An error code is displayed at Relax and do not move during E56 measurement the measurement If this error E57 occurs many times repair is necessary Interval setting error Start time is not proper interval of Enter parameters for the interval E60 last block is not set in the unit of correctly 120 min E70 RS 232C error The error code is displayed during Re connect the communication E71 communications cable If you can not clear this E72 error the product needs repair E73 E74 Low battery for Replace batteries with new ones communication and restart communication Protocol error due to Re connect the communication E75 external equipment cable If you can not clear this error the product needs repair E90 Pressu
20. Selection for the Automatic Measurement Please proceed to Step 6l Set up new parameters for display and clock and automatic measurement if necessary Delete the old data stored in the recorder Refer to the section Deleting Old Data Explain the Patient Instructions and Notes on the Blood Pressure Recorder to the patient Case 1 Normal Case 2 Error Step 4 Step 5 Step 6 Step 7 Next page Page 13 Step 8 Step 9 Step10 Step11 Step12 Step13 Step14 Step15 Step16 Attach the cuff to the patient Refer to Attaching the Cuff and Recorder Attach the carrying case to patient and insert the recorder Refer to Attaching the Cuff and Recorder Start the automatic measurement The recorder displays an A Refer to Automatic Measurement The recorder starts the automatic measurement sequence Check the recorder using the manual measurement with relaxed but correct posture Refer to Manual Blood Pressure Measurement When using automatic measurement consider the following L Consider the sections Patient instructions and Notes on the Blood Pressure Recorder LI When the patient uses mode Il of automatic measurement press the AUTO ON OFF key with each rising and going to bed
21. TO ON OFF key so as to display 6 for 6 00 hours as AUTO ON OFF nme E a a To next page the start time of the third block Page 20 From previous page Step13 Press the START STOP key The current frequency of the third START STOP block is displayed Wo Step14 Press the AUTO ON OFF key so as to display 10 for 10 AUTO ON OFF minutes as the frequency of the third block uainn Step15 Press the START STOP key The current start time of the fourth START STOP block is displayed Hia Step16 Press the AUTO ON OFF key The recorder stores these START STOP parameters and displays the clock because the current start Me time of the fourth block is the same start time of the first block Page 21 Deleting Old Data Caution Confirm that the data has already been transferred and saved when the data is to be deleted It is not possible to recover data that was deleted It is not possible to delete data completely if the START STOP key is released while the buzzer sounds at Step 2 Steps for deleting old data Step 1 Step 2 Press and hold the START STOP key for approx 9 seconds is displayed If you want to cancel this process press the AUTO ON OFF key Press and hold
22. ace and adapt to the RS 232C protocol of the recorder Specifications for an adaptable printer Page 28 Transmission EIA RS 232C Asynchronous bi directional half duplex Baud rate 9600 bps Start bits 1 bit Data bits 8 bits Parity bit None Stop bits 2 bits X parameter Not used ETX ACK Not used DSR Not used Code ASCII Command Carriage return ODh Next line ODh OAh Next page OCh ODh Printer parameters Next page Automatic Characters per line 72 min Buffer size approx 32Kbytes Steps for data transmission Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Enter the parameters into the printer so that the data can be transmitted Connect the cable to both the recorder and printer Then the recorder displays Refer to Analysis Software and Communication Cable about the cable Set the printer to ON LINE Press the START STOP key Then is displayed and the data is transmitted When the transmission is finished is displayed Remove the cable at once The clock is displayed Print sample thie et tro e Setup for printer J Connection On line Ready START STOP co A Ea Remove the cable ABPM DATA TABLE Page 29 Date Time SYS mmHg DIA mmHg PUL bpm ERR 97 5 1
23. act your nearest A amp D office for this inspection Environmental protection If you disuse the recorder remove Ni Cd battery and built in Li battery from this recorder Disuse Ni Cd battery to its exclusive trash can because of recycling it Dispose of Li coin battery in the recorder as dangerous object properly Page 5 Kd Welcome Welcome and Intention nnnm Thank you for your Purchase The A amp D TM 2430 ambulatory blood pressure recorder enables you to accurately take a patient s blood pressure automatically at different preset times throughout a 24 hours period Recently in the treatment of patients with hypertension there has been an increasing need to prescribe medication according to the particular blood pressure fluctuation pattern of the patient These patterns can be made more evident by using the TM 2430 recorder and analysis by a physician This manual will explain in simple language how this recorder works Patient This blood pressure recorder is designed for an adult patient Environment This blood pressure recorder is used in a hospital and or patient s home iv Packing List and Component Names When you open this box make sure you have everything as shown here Instruction manual Blood pressure recorder Main unit Carrying case Shoulder band Belt Cuff covers for adult cuff Activity record sheets Adult cuff for left arm Battery cover Alkaline batteries ty
24. ata can be output as a report LI Data is input from the recorder and parameters are written to the recorder Name Order code Windows based analysis software TM2430 13 Communication cable D SUB 9pin socket type AX KO1502 Communication cable D SUB 25pin socket type AX KO1503 Communication cable D SUB 25pin plug type AX KO1504 Page 31 CJ Cuffs and Other Accessories Cuffs for serial no M0600001 to M0600500 Name Order code Large cuff for leftarm 28 36 cm 11 14 inches TM2430 02 Adult cuff for leftarm 20 31 cm 8 12 inches TM2430 06 Small cuff for leftarm 15 22cm 6 8inches TM2430 07 Adult cuff for right arm 20 31 cm 8 12 inches TM2430 09 Cuffs for serial no M0600501 or over Name Order code Large cuff forleftarm 28 36cm 11 14 inches TM2430 02A Adult cuff forleftarm 20 31 cm 8 12 inches TM2430 06A Small cuff for leftarm 15 22 cm 6 8inches TM2430 07A Adult cuff for right arm 20 31 cm 8 12 inches TM2430 09A Cuff sleeves Name Order code Large cuff sleeve for left arm 2 sleeves AX 133003299 S Adult cuff sleeve for left arm 2 sleeves AX 133003137 S Small cuff sleeve for left arm 2 sleeves AX 133003298 S Large cuff sleeve for right arm 2 sleeves AX 133003460 S Adult cuff sleeve for right arm 2 sleeves AX 133003300 S Small
25. atient moves and they will not slip off Prevent the air hose from breaking during sleep Affix the air hose to the patient s body only as shown on page 24 Replacing the batteries O Replace with new batteries quickly when B is displayed Page 23 W Use of the cuff cover Step 1 Pass the air hose through the slit Step 2 Place the cover on the cuff as shown Link them using the three velcro strips Velcro Cuff cover common use Left arm cuff iv Attaching the cuff and recorder Caution If the cuff is not attached at the right position the recorder may not measure the blood pressure correctly and an error may occur The cuff accessory is for use on the left arm of about 20cm 31cm If you need a different cuff purchase a cuff of the proper size and arm position Refer to Option and Accessories Do not use if the patient has dermatitis etc Keep the cuff clean Exchange the cuff cover for each patient The cuff cover may be used for both right or left Steps for attaching the cuff and recorder Step 1 Make a circle where the end of the cuff is passed through the ring Step 2 Search for the brachialis artery using palpation Page 24 Step 3 Attach the cuff directly against the skin so that the yellow mark is directly over the brachialis artery and space it one inch above the inside of the elbow and the lower edge of the cuff
26. e When memory becomes full the recorder displays an M Until you clear the data you can not measure blood pressure When the recorder saves data for more than one patient data management becomes complication We encourage that a patient s data is recorded transferred and is cleared from memory Page 10 ID number When a B is displayed the backup batteries that is preserving a patient s data are weak Please transfer the data and save it to other media as soon as possible If you reset the recorder the ID number is set to 1 LI The ID number can be set using the optional software Performance specifications Measurement method Oscillometric Pressurization micro pump Display range Automatic measurement Manual measurement 0 320 mmHg 85 300 mmHg Fitted 185 mmHg Fixed Measurement range Systolic Blood Pressure 60 280 mmHg Diastolic Blood Pressure 40 60 mmHg Pulse rate 30 200 bpm Accuracy Pressure 3 mmHg Blood pressure Conforming to 1992 AAMI standard Pulse rate 5 Minimum display division Pressure 1 mmHg Pulse rate 1 bpm Depressurization Constant exhaust Controlled ceramic valve Exhaust Ceramic valve Measurement Automatic measurement Manual measurement Number of measurement Apporx 200 times It may reduce this number due to environment and capacity of Ni Cd batteries Memory Up to 300 sets of data Display Normal Clock During a measureme
27. e and a defibrillator O Do not use this recorder on a person who is critical or is in an intensive care unit Saving power LI Turn off the power switch when not in use L Please transfer the data as soon as possible All measurement data clock parameters measurement parameters and internal system parameters are preserved by backup battery when turning the power switch off The backup battery life is few days Data in memory A built in backup battery keeps the important data in memory while replacing the main batteries However it works for a short period of time perform the battery replacement swiftly or you may lose measurement data the clock setting information and Page 3 automatic measurement condition data The period varies depending on the battery condition The backup battery may take 24 hours or more to be fully charged depending on the battery condition L The built in backup battery rechargeable as well as the primary battery not rechargeable will deteriorate along use which causes to decrease its capacity The built in backup battery will deteriorate due to repetitive backup operations To prevent the sudden drop of the built in battery life observe the following Before using the monitor for the first time after purchase or after an extended period of no use charge the battery fully It takes 24 hours or more with the power switch turned on C
28. ected Step 1 Press and hold the START STOP key for about 3 seconds The Lu STOP current mode is displayed Step 2 Press the AUTO ON OFF key so as to display 2 of AUTO ON OFF mode II 2 Step 3 Press the START STOP key The recorder stores the mode and START STOP displays the clock etal Page 18 Mode Ill Settings Set up procedure Before you enter into mode Ill read the procedure below Also refer to the example on the next page for the setting procedure LI Each blocks starting time must match the previous blocks finish time LI The end of block 6 automatically equalizes to start time of the block 1 O If you enter the block 1 start time in any other block these parameters are saved and this sequence is finished L When selecting 120 minutes for the current frequency you must adjust the start time of the next block so that the current block fits a multiple of 120 minutes If you do not fit to the next start time an error code is displayed O The recorder displays as 60 minutes and as 120 minutes LI When you enter the sequence of mode Ill settings the recorder initializes each start time to the start time of block 1 and each frequency to not used To read the current settings press the START STOP Display amp key Parameter moa o bit tet Sign of sett
29. elt 6 7 25 block 2 18 19 20 bpm 2 C Cable 31 ear eree eencncertor ee 22 clock _ 8 11 16 code 12 Constant exhaust 2 CSV 31 cuff 4 6 24 25 31 32 cuff cover 24 32 D D SUB __ 31 data bits _ 12 Depressurization _ 11 DIA 2 diastolic 8 Diastolic Blood Pressure 2 dimensions _ 12 Display 11 DSD __ 2 E at commen einen 16 22 35 EEC _ 2 Error state 13 EXECL 31 Exhaust 2 Exhaust velocity 2 F FCC 2 frequency 2 18 19 20 full memory _ 8 H hiding the measurement value 10 I ID number 11 interface 12 interval 2 18 L large cuff 31 32 leftarm
30. ervice from your supplier or from the A amp D service group A amp D service group will support authorized suppliers about technical information spare parts and units Problem Cause Treatment No display at turning Battery power has been Replace with new batteries on consumed Data lost while Unable to charge the Set for clock display for approx replacing batteries internal sub battery 24 hours This battery charges during clock display No pressure Air leakage at the Confirm the cuff and air hose connected correctly connector hose or cuff are not damaged and are Page 34 ww Error codes Caution The error code updates without announcement Ha Meaning Status Operation and Treatment code E00 No clock parameter All parameters are lost Enter clock parameters Refer Reset status to Setup of display and clock E03 Pressure zero error An error code is displayed Release the air from the cuff without cuff inflation completely Low battery Measurement is stopped Replace with new batteries E04 An error code is displayed Restart the auto mode if you use it Auto mode is quit Inflation error Inflation pressure does not Wrap the cuff and connect to main E05 reach the target pressure unit exactly If you can not clear the error there may be an air leak and repair is necessary Above 320mmHg An error code is displayed Do not move and tr
31. harging can be performed during measurement After measurement leave the battery inside and the power switch turned on Under this condition the built in battery will not deteriorate This is true with the B sign displayed When the monitor is not to be used for a month or longer turn the power switch off to prevent the main batteries from leaking During an extended period of no use the built in battery will deteriorate To prevent the situation use the monitor regularly When the power switch is tumed on and off after a short period of use the built in battery will not be fully charged and the battery life will decrease Avoid this situation Cuff Close the cuff fastener properly when attaching the cuff to a patient or replacing the cuff cloth If the fastener is closed incorrectly inflating cuff may damage this cuff The cuff contains dry natural rubber Page 4 CJ Notes on the Blood Pressure Recorder Storage Do not store the recorder in the following places L Where the recorder might be splashed with water or other liquids If the recorder soaked it needs a repair Do not use the recorder Where the temperature and humidity are high or in direct sunlight LI Where the recorder may be influenced by vibration or shock Where there is du
32. hat is within 3 mmHg Squeeze the inflator bulb until cuff pressure reaches to 250 mmHg Check this difference that is within 3 mmHg Release the cuff air turn off the TM 2430 and remove them This blood pressure recorder is a precision instrument Contact your nearest A amp D office for this inspection if you need repair Page 33 W Cleaning the cuff and recorder Before cleaning the recorder remove the battery cover and turn the power switch off Remove the batteries The recorder is not water resistant do not allow liquids to splash on or get into the case while cleaning After each use wipe the case of the recorder with a clean lint free cloth moistened with water and a mild detergent Do not use antiseptic solutions Alcohol etc to clean the recorder hose or cuff Clean the cuff cloth and cuff cover by washing in water with a mild detergent Do not scrub or wring them by hand If the cuff cloth and cuff cover become contaminated replace them with new covers W Periodical inspection O This blood pressure recorder is a precision instrument Please inspect the functions every year periodically Contact your nearest A amp D office for this inspection W Problem solving Caution Do not open the case of the recorder because it uses delicate electrical components and intricate air unit that could be damaged If you can not locate and fix the problem request s
33. he cuff air During a measurement This means a period between the start of cuff inflation and the end of exhausting the air Interval This is called block A block consists of a start time and frequency bpm beats per minute Page 2 W Precautions for Use Precautions Batteries L Use alkaline batteries LR6 type AA type Mignon or suitable Ni Cd batteries LI Do not mix new and used batteries in the recorder LI Remove the batteries from the recorder if it will not be used for a long period of time and unless there is no risk of a SAFETY HAZARD arising A malfunctioning recorder LI If the recorder malfunctions stop the operation attach a note Do not use this recorder and store in a safe place to avoid mis use Training LI Instruct the patient on how to stop the operation if there is an abnormal measurement and how to remove the cuff if there is excessive arm pain LI Advise the patient on how to cope with mis operation and contingencies Repair LI Do not open the recorder case Contact the nearest A amp D office if you have questions Blood pressure measurement O Use the recorder for adult LO The recorder may not make a measurement when a patient has continuous arrhythmia or the recorder senses noise due to the patients movement LI Please check measurement values by other methods if you suspect an value LI Do not use this recorder on a person who is using a heartlung machin
34. ing parameters Sequence number for automatic measurement START AUTO STOP La onor Selecting a sequence number Selecting a parameter key in this sequence Items Sequence Parameters monitor Meaning Initial value number 01 0 23 o clock Start time of first block sia 02 5 10 15 20 30 60 120 minutes Frequency of first block Heian 03 0 23 o clock Start time of second block noe 04 5 10 15 20 30 60 120 minutes Frequency of second block H 3it 7 05 0 23 o clock Start time of third block aa 17 06 5 10 15 20 30 60 120 minutes Frequency of third block Ha 7 07 0 23 o clock Start time of fourth block Hio 08 5 10 15 20 30 60 120 minutes Frequency of fourth block 54 7 09 0 23 o clock Start time of fifth block na 10 5 10 15 20 30 60 120 minutes Frequency of fifth block mo 11 0 23 o clock Start time of sixth block io 12 5 10 15 20 30 60 120 minutes Frequency of sixth block tea 13 0 23 o clock End of sixth block i The means not used Page 19 Steps for automatic measurement ex First block 08 00 21 59 frequency is 30 minutes Second block 22 00 05 59 frequency is 60 minutes Third block 06 00 07 59 frequency is 10 minutes O MER Step 1 Press and hold the START STOPI key for approx 3 seconds The START STOP cu
35. nd clock This explanation uses the following examples Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step10 Step11 Step12 ex After reset the measurement value is not displayed The clock is adjusted to 1997 05 27 14 28 Press and hold the recorder clock START STOP key for approx 6 seconds The displays i i for adjusting the display and Press the AUTO ON OFF key so as to display A selection where a clock is displayed only in automatic measurement Press the START STOP key The current year is displayed Press the START STOP key The current month is displayed Press the AUTO ON OFF key to display 5 for May Press the START STOP key The current day is displayed Press the AUTO ON OFF key to display 27 27th day Press the START STOP key The current hour is displayed Press the AUTO ON OFF key to display 14 14th hour Press the START STO key The current minute is displayed Press the key to display 28 28th minute Press the START STOP key to save these parameters Then the recorder displays the clock Page 17 START STOP
36. nt Pressure value After a measurement SYS DIA and pulse rate Error code function of concealing the measurement data Clock 24 hours 1997 2096year automatic leap year setting Batteries 3 x Alkaline battery type LR6 type AA Mignon or 3 x Ni Cd battery type AA Mignon Type of protecting Internally powered equipment type BF It against electric shock CE Marking The label of the medical device C 0366 by the EC directive C Tick Marking The certification trade mark registered to the ACA by the Trademark office no2 AAMI Association for the Advancement of Medical Instrumentation ACA the Australian Communications Authority CE marking and C Tick marking are labeled only where they are required Page 11 Interface Connected to a computer you can output the data and enter parameters Connected to a printer you can print the data EIA RS 232C Asynchronous bi directional half duplex Baud rate 9600 bps Data bits 8 bits Stop bits 2 bits X parameter Used for computer Not used for printer Parity None Code ASCII RS 232C ESER E WISE aa 1 5V 15V pe ee Lf 5V 15V SaN Di Data bits Stop bits Environment specifications Operating environment 10 C 40 C 50 F 104 F Less than 85 RH Transport and Storage 20 C 55 C 4 F 131 F Less than 95 RH Non Condensing Physical specifications
37. ocity adjustment is unnecessary because the constant exhaust is properly controlled In the automatic measurement these inflation value and stop value at exhaust is managed to reduce the measurement time Functions and Specifications Blood pressure measurement There are two ways of blood pressure measurement Automatic measurement This automatic measurement works in accordance with internal clock preset time intervals and preset mode The measurement data is saved in memory Manual measurement Any time you press the START STOP key a blood pressure measurement is performed immediately The measurement data is saved in the memory Page 9 Automatic measurement This measurement starts or stops using the AUTO ON OFF key When this measurement is started the recorder begins to work in accordance with preset time intervals from the preset time of the internal clock Refer to Selection for the automatic measurement In the automatic measurement an A appears in the upper left of the display The recorder automatically measures the patient s blood pressure at the time that is pointed out by the frequency and the start time by the programed time intervals When a measurement error occurs and there is 8 minutes until the next measurement the measurement is retried after approx 30 seconds If a measurement is retried only the data from
38. pe LR6 type AA Mignon The batteries are not included in this pack Auto ON OFF key Start Stop key Shoulder band Air hose Reset key Power switch a RS 232C terminal Name Functions Power switch This is the main power switch At the OFF state all data and parameters are preserved by an backup battery This backup battery life is approximately 10 days with the power off AUTO ON OFF key When you press and hold the AUTO ON OFF key the automatic measurement is started or stopped alternately When you press the key at mode II of the automatic measurement S is displayed or turned off alternately This sign changes the interval for sleep START STOP key When you press the START STOP key a blood pressure measurement is started at once When you press and hold the START STOP key for approx 3 seconds the recorder proceeds to Selection for the automatic measurement When you press and hold the START STOP key for approx 6 seconds the recorder proceeds to Parameters for the display and clock When you press and hold the START STOP key for approx 9 seconds the recorder proceeds to Deleting old data RS 232C terminal This terminal is used for data output to a printer or computer The optional RS 232C cable is necessary to output the data Reset key All data and parameters are
39. re zero error for This error code is displayed before Release the air from the cuff safety circuit the measurement completely Safety circuit detects Patient moved during the Relax and try to quiet during the E91 over load pressure measurement measurement If it occurs in quiet the recorder needs repair Oier Monitor code is displayed Reset Turn on power switch again Page 36 Symbols ese ka aa Sa eet 8 oe 8 E O a ee Se 8 Doa actin 8 1007 Ol eel eles as 8 7A See mR OPEN 8 BR ee 8 PR wane nn nn nnn nnn nana 8 16 18 i T 18 2 iS 18 i iS 19 19 29 30 SN 8 A A 8 10 27 AAMI _ 12 accuracy 11 adult cuff 31 32 air hose 7 24 air plug 7 25 alkaline battery 3 11 analysis 9 31 arrOoW _ 8 artery 24 AUTO ON OFF key 7 automatic measurement 7 8 10 27 B B 8 11 15 battery 3 15 battery cover 7 baud rate 12 b
40. rect current Serial number Date of manufacture Attention symbol See instruction for use Recorder Cuffs and tubings are designed to have special protection against electric shocks Page 8 Specifications y Features Portability The recorder weighs approx 215g including batteries and is palm top size because a micro pump is used The recorder is powered by LR6 type Mignon alkaline batteries It is possible to replace the LR6 type batteries with Ni Cd rechargeable batteries Operation amp management O Clock and automatic measurement parameters may be set as needed If you connect to a computer and use the optional software clock and automatic measurement parameters can be set easily There are three modes for automatic measurement The recorder can transmit data to a printer directly An adaptable printer is necessary to print the data Refer to Section Data Transmission to a Printer for specifications of the printer The recorder has the built in chargeable coin Li battery to keep the clock and automatic measurement parameters Analysis The time interval may be changed as needed The patient s blood pressure can be measured immediately at any time If you use the optional software you can analyze the data widely Smart measurement v The measurement time is shortened by proper exhaust velocity control The exhaust vel
41. rrent mode is displayed Step 2 Press the AUTO ON OFF key so as to display 4 for AUTO ON OFF mode Ill a Step 3 Press the START STOR key The mode is stored and the current start START STOP ss He time of the first block is displayed Step 4 Press the AUTO ON OFF key so as to display 8 for 8 00 hours as AUTO ON OFF mt D the start time of the first block sae eae Step 5 Press the START STOP key The current frequency for the first block SARTEN STOP is displayed LE Step 6 Press the AUTO ON OFF key so as to display 30 for 30 minutes AUTO ON OFF as the frequency for the first block Step 7 Press the START STOP key The current start time of the second START STOP block is displayed ami Step 8 Press the AUTO ON OFF key so as to display 22 for 22 00 hours as AUTO ON OFF the start time for the second block Uu Step 9 Press the key The current frequency for the second ey STOP block is displayed ap Step10 Press the AUTO ON OFF key so as to display for 60 minutes as AUTO ON OFF the frequency of the second block A ih Step11 Press the START STOP key The current start time of the third block START nF is displayed oc Step12 Press the AU
42. st salt or sulfur Where medicines are stored or medicines are evaporating Before use Cover the RS 232C terminal using the rubber cap to avoid dust Confirm that the recorder works correctly and measurement values are proper Confirm that the cuff and air house are connected properly Confirm parts of contact with patient directly Keep clean for these parts Use clean cuff cover because of contact with patient directly Clear the old data before starting a new measurement Avoid strong magnetic field and static electricity Do not use this recorder with a high frequency surgical equipment During use The recorder should be operated by a physician who knows it well Use the recorder only during the time of diagnosis or medical treatment Stop the use if the patient feels pain in his arm or the recorder does not measure properly It may reduced the measurement cycle due to environment When an inside part of the recorder has been soaked wetted turn off the power switch and request service to your supplier or the A amp D service group After use Clean the recorder cuff and accessories for the next use Do not pull or kink hoses Do not use organic solvent antiseptic solution etc Turn off the power switch after measurement Please use the original box for transportation Periodic maintenance The recorder is a precision instrument Please check all functions every year periodically Cont
43. tient s blood pressure within one minute after the measurement Also relax and be quiet during measurement The maximum measurement time is 90 seconds There is the case of re measuring the blood pressure during the last measurement This is in case the recorder did not acquire usable data and the frequency of the interval is above 8 minutes The patient should relax and not move during the measurement Stop the use if the patient feels pain in his arm Stopping or canceling an automatic measurement O When the patient is to stop a measurement press the START STOP key The recorder beeps releases the cuff air and an error is displayed The recorder will inflate the cuff for the next time period automatically When the AUTO ON OFF key is pressed and held for approx 3 seconds the recorder stops re starts automatic measurement and the A disappears appears This key operation can select alternately Manual measurement For the patient to start a measurement at once press the START STOP key For the patient to stop this measurement press the START STOP key Attention while attaching the cuff and recorder Do not drop or shock the recorder The recorder and cuff are not water resistant Prevent rain sweat and water from wetting the recorder and cuff Do not place anything on the recorder Re attach the cuff and recorder when p
44. y to relax E06 during the measurement If you can not clear the error the product will require repair E07 Controlled stop Air is exhausted An error Do not press the STOP key if using STOP key code is displayed you do not need to use it Pulsation can not be Measurable pulsation is Do not move and try to relax measured searched to 20mmHg in during the measurement The E08 constant exhaust An error error occurs when measurable code is displayed pulsations are not received due to thick cloth or quick motion Pulsations can not In the measurement Quick Do not move and try to relax E10 be detected exhaust is executed An during the measurement because the patient error code is displayed may have moved E20 Pulse rate lt 30 An error code is displayed Measure the blood pressure by 200 lt Pulse rate other methods E21 DIA lt 40 160 lt DIA DIA Diastolic Blood Pressure E22 ec SYS Systolic Blood Pressure 280 lt SYS DSD The Difference between Systolic Blood Pressure E23 oe and Diastolic Blood Pressure 150 lt DSD Page 35 Error Meaning Status Operation and Treatment code Measurement is Air is exhausted from the cuff and Repair is necessary because of E30 greater than 120 an error code is displayed slow inflation or slow constant seconds exhaust The constant exhaust Air is exhausted from the cuff and Repair is necessary because of
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