User guide for Meditech ABPM-05
Contents
1. d This warranty is valid at the representative address of Meditech Ltd unless otherwise displayed upon a commercial invoice or any other valid business document duly signed by the supplier and the recipient of the Meditech product If such business document displaying a certain site for warranty validity cannot be presented this warranty is valid at Meditech HQ office in Budapest Hungary This warranty does not cover any malfunction or defects of the recorder unit or any of its accessories arising from improper use the use of inadequate accessories accident theft or use of the recorder unit outside its operating environmental specifications and intended measurement range Removing the closing label from the back side of the recorder unit or opening the unit any other way voids this warranty EXCLUSION OF BIOHAZARD Meditech will not accept for repair potentially infectious products or accessories especially pouches and cuffs that might have been in direct contact with the patient and could not be or potentially were not properly disinfected even within the warranty period If a problem occurs within the warranty period such accessories will be replaced without any physical inspection reserving the rights to hold an inspection when found necessary NO OTHER WARRANTIES Meditech disclaims all other warranties either expressed or implied including but not limited to implied warranties of merchantability and fitness for a2. Cancel a blood pressure measurement The patient can interrupt a blood pressure measurement by pressing a button at any time while the cuff is inflated This will result in immediate fast cuff deflation Such interruption is limited to the measurement in progress only and has no effect on further operation This function is available with all three buttons Manual blood pressure measurement If it seems necessary the patient can start an additional manual blood pressure measurement by pressing the START button shortly The result with a manual measurement marker will be stored in the memory of the device Typical causes for this use dizziness pain angina pectoris or headache palpitation Switching the device off Press and hold the START button for more than 10 seconds then release it when two horizontal segments appear on the LCD this way ABPM 05 will be switched off If you do not release the button in 2 seconds after the two horizontal segments appeared the recorder will return to normal operation This feature helps to avoid unintended power off The device can only be switched on manually While the recorder is switched off normal functions are not available even prescheduled measurements will not be triggered Therefore switching off the device is only necessary in case of valid reasons Switching the device on ABPM 05 is switched on to normal operation if the START button is pressed and held for more than 3 seconds If the d
3. Monitoring session typically 24 hours 10 Remove the unit and cuff from the returned patient 11 Ask for the patient diary and ask the patient for any events symptoms observations or complaints 12 Start the CardioVisions program and select the ABPM 05 recorder type 13 Connect the device to the PC and then transfer collected data from the recorder to your database 14 Analyze the blood pressure profile 15 Create and print a report 14 Batteries ABPM 05 ambulatory blood pressure recorders operate with two 1 5V AA batteries or two 1 2V AA rechargeable batteries Use only standard long life alkaline batteries or standard NiCd or NiMH rechargeable batteries of the proper size Do not use lithium batteries Do not mix different battery types do not mix new and old batteries Never use batteries of low or unknown quality or pre used batteries as they may not cover the power needs of the recorder and they may damage the recorder or they may contain acidic electrolytes which may leak and corrode electronic components Never use batteries damaged in any way Should the batteries run down during a monitoring session they can be replaced Monitoring will continue and data will not be lost If you do not use the recorder it is advisable to remove batteries since they may run down due to the constant small power consumption of the integrated circuits of the device Data in the recorder are not lost even if batteries run dow
4. a B a m Elderly patient a E E Autonomic failure Contraindications Non cooperative patients unconscious or otherwise incapable patients Patients requiring urgency emergency cardiac care Patients with coagulation disturbances for ABP monitoring Patients with serious mobility or other impairments without supervision Children without supervision children younger than 8 years Though the blood pressure measurement algorithm used in ABPM 05 has been found to function properly on patients with atrial fibrillation or other common arrhythmias the oscillometric blood pressure measurement method is generally recommended for use only with special caution in patients with arrhythmias Parkinson s disease or other diseases with tremor Meditech ABPM 05 The ABPM 05 device i is a compact lightweight monitoring unit typically worn by the LCD START button EVENT button DAY NIGHT button Cuff connection O Interface connection ABPM 05 patient for 24 hours ABPM 05 is a compact lightweight device which operates with two AA size accumulators or batteries The memory is capable of storing 600 measurements Stepwise pressure deflation ensures quality measurements even if disturbing environmental factors occur You may find the battery compartment and the rating label on the backside housing The serial number is placed on the rating l
5. of the relevant standard is protected against a defibrillator discharge Caution Substitution of a cuff different from that supplied might result in measurement error and or in certain cases cause damage to the main recorder unit 16 Meditech product warranty information a RECORDER WARRANTY The main recorder unit will be free from defects in materials and workmanship under normal use and service for a period of two 2 years from the date of receipt This warranty covers the recorder unit only This warranty does not cover any accessories that might come with the recorder unit ACCESSORIES WARRANTY The non disposable accessories delivered with the recorder unit will be free from defects in materials and workmanship under normal use and service for a period of one 1 year from the date of receipt This warranty does not cover disposable accessories packaging materials accumulators and batteries cuffs or any of their components c CUFF WARRANTY The cuff s if delivered with a recorder unit will be free from defects in materials and workmanship under normal use and service for a period of six 6 months from the date of receipt This warranty covers the cuff s delivered with a recorder unit exclusively SOFTWARE WARRANTY The CardioVisions software under normal use will perform substantially in accordance with the accompanying written electronic documents for a period of ninety 90 days from the date of receipt b
6. particular purpose with regard to the recorder unit any accessory or other accompanying hardware and the CardioVisions software NO LIABILITY FOR CONSEQUENTIAL DAMAGES In no event shall Meditech be liable for any special incidental indirect or consequential damages whatsoever including without limitation damages for loss of business profits business interruption loss of business information loss of data or any other pecuniary loss arising out of the use of or inability to use the recorder unit its accessories and or the CardioVisions software even if Meditech has been advised of the possibility of such damages 17 EMC information Medical electrical equipment should be used with precautions according to EMC and must be installed according to the EMC notices disclosed in this manual as mobile RF transceivers could adversely affect it Directive and declaration of manufacturer Electromagnetic Emission ABPM 05 is suitable for use in the specified electromagnetic environment The purchaser or user of Meditech ABPM 05 should assure that it is used in an electromagnetic environment as described below Emission test Compliance Electromagnetic Environment Radiated and conducted Group 1 ABPM 05 uses RF energy only for its RF emission internal function Therefore the emission CISPR 11 is very low and not likely to cause any interference in nearby electronic equipment Radiated and conducted Class B ABPM 05 is su
7. result of individual readings on its LCD The most important displays are listed here In addition to these most important displays a lot of extraordinary situations and errors have their own code displayed on the LCD These codes are stored together with recorded data and they are listed in the CardioVisions program This helps service personnel to identify causes of an unexpected behavior result or error ube 3 m us Li or rok Z ia Normal status time is displayed Blood pressure measurement initiated Deflation during blood pressure measurement the current pressure is displayed mmHg Systolic value of just completed measurement mmHg Pulse rate value of just completed measurement beats per minute Event marker set due to button push Communication with personal computer Error code display The recorder is switched off Li res on mos fp ts tons oo Pam Zoo mo hot af Night mode time is displayed moon sign is lit Pumping for measurement current pressure mmHg Heart symbol blinking in tune with pulse measurement in progress Diastolic value of just completed measurement mmHg Blood pressure measurement cancelled by pressing a button The crossed battery symbol warns about low battery LCD check all segments are displayed Battery voltage display 2 37 V
8. 3 5 V VP Radiated RF IEC 61000 4 3 3V m 80MHz 2 5GHz 3V m d 3 5 3V m VP 80MHz 800MHz d 7 3V m P 800MHz 2 5GHz where P is the highest radiated power disclosed by the manufacturer of transmitter W d is the recommended separation distance m 1 note in case of frequency 80MHz or 800 MHz the formula for the higher range is applicable 2 note These are guidelines Actual conditions may vary 20 Recommended separation distance ABPM 05 is intended to be used in electromagnetic environment with controlled RF disturbances The purchaser or user of ABPM 05 may help to reduce electromagnetic disturbances by defining the separation distance between the transportable or mobile RF telecommunication equipment transmitters and ABPM 05 depending on the highest output power of the telecommunication equipment Separation distance in function of the frequency of the transmitter m The highest 150KHz 80MHz 80MHz 800MHz 2 5GHz PE rA d 3 5 VJNP SOME d 7 E NP w d 3 5 E1 NP 0 01 Not applicable 0 12 0 23 0 1 Not applicable 0 38 0 73 1 Not applicable 1 2 2 3 10 Not applicable 3 8 7 3 100 Not applicable 12 23 If this table does not contain the highest output power of the transmitter the d separation distance m can be calculated by the formula depending on the frequency of the transmitter where P is the rated highes
9. Meditech 000 eet ambulatory blood pressure monitor Important information precautions for use read carefully AN Meditech eee ee o a o model BPS This symbol on a Meditech recorder is a warning that you should read the accompanying documentation this manual The ABPM 05 ambulatory blood pressure recorder is manufactured by Meditech Ltd 200 Ulloi ut Budapest Hungary www meditech eu fax 36 1 282 9388 e mail meditech meditech eu Contact us for further product and service information Meditech Ltd maintains a quality assurance system certified according to MSZ EN ISO 9001 2000 and MSZ EN ISO 13485 2003 Notified Body SGS Yarsley Unit 202b Worle Parkway fax 44 1934 522 137 Weston super Mare BS22 OWA www sgs com ABPM 05 recorders should not be used if any of the following cases apply patients without an indication for ambulatory blood pressure monitoring non cooperative patients patients in any way unable to operate a recorder as intended patients requiring urgency emergency cardiac care unconscious or otherwise incapable patients patients with serious mobility impairments without supervision patients with coagulation disturbances children without supervision children under the age of 8 years Though the blood pressure measurement algorithm used in ABPM 05 recorders has been tested and found to function properly on patients with atrial fibrillation or other common arrhythmi
10. N E A EA 9 Technical parameters ssoi care an a i cas berets E denote A A E E E E 10 Care and maintenance sesseeessesseesseesressresrressresrressesrtesseesrressessteesesrrsssessresseesseesse 11 Safety COnNCErNS areires in a EE E R OAE a AEO AEE aa aaa AEAEE 12 Working with ABPM QSaiesnesnioisiennenn iali aiiis 13 Rules f monitorning erered etine i E aane a SGE 13 Connecting the ABPM 05 recorder to the PC cece ceeccceesecesteceteceeteenteeeesaeees 13 Mo nitorin step by SRC seaas aces see teetdet sd Succ eae abn a a Meta tae ota a utes 14 PAULL LES oerni o a aaa anaa Aaaa E aR nde aa ia Ata eaaa 15 Cuffs and their application esssseseeesseeseeesssseesseeseressessetessessressessessressressessseesse 16 Meditech product warranty information cccccceeccceesecesteecesceceseeeeeeeenteeeeseeensaes 17 EMC information ces en ae ok ete eee ae ee aes 18 NODES scsi eieioetg td iaeaea peee idee aut eaaa ASA hedaman deeded dee ites 22 Recommended use of ambulatory blood pressure recorders Indications for ambulatory blood pressure monitoring The following indications are listed in the European Society of Hypertension recommendations for ambulatory blood pressure measurement 2003 Suspected white coat hypertension Suspected nocturnal hypertension To establish dipper status Resistant hypertension As a guide to antihypertensive drug treatment Type diabetes Hypertension of pregnancy Evaluation of hypotension a
11. Technical parameters Power supply 2 AA rechargeable NiCd or NiMH batteries or 2 AA alkaline batteries Display liquid crystal Data storage internal solid state memory Data transmission on serial or USB optical cable 115200Baud PC interface special optoelectronic serial or USB interface Operating environment Temperature 10 45 C Humidity 10 95 non condensing Atmospheric pressure 70 106 kPa Storage conditions Temperature 20 50 C Humidity 10 95 non condensing Size 70 x 99 x 30mm Weight app 240 g batteries included Blood pressure measurement method oscillometric Blood pressure maximum storage over 600 measurements Pressure measurement range 0 300 mmHg Static accuracy 3 mmHg or 2 of measured value stability 2 years Blood pressure measurement range 30 260 mmHg Pulse rate measurement range 40 200 beat per minute Blood pressure measurement accuracy same measuring algorithm as used in the ABPM 04 which has been validated according to the BHS protocoll Pressure sensor piezo resistive Inflation automatically controlled pump Safety maximum inflation 300 mmHg independent safety release valve Deflation and rapid air release automatic pressure release valve Please note that the ABPM 05 might not meet its performance specifications if stored or used outside the specified environmental conditions 10 Care and maintenance Protection and cl
12. a short interruptions dip for 0 5 cycle applicable typical commercial and or and voltage hospital environment If the user me 40 y variations on nae oe dip of Meditech ABPM 05 requires power supply CLINICAL UTILITY during input lines 70 Ur 30 dip power mains interruptions it is IEC 61000 4 11 for 25 cycles recommended that parts of the lt 5 Ux gt 95 Meditech ABPM 05 system dip for 5 sec where applicable be powered from an uninterruptible power supply Power frequency 3A m 3A m Power frequency magnetic fields 50 60Hz magnetic field IEC 61000 4 8 are at levels characteristic of a typical location in a typical commercial and or hospital environment Note Ur is the nominal voltage of mains 19 Directive and declaration of manufacturer Electromagnetic immunity Meditech ABPM 05 is suitable for use in the specified electromagnetic environment The purchaser or user of Meditech ABPM 05 should assure that it is used in an electromagnetic environment as described below Immunity test IEC601 1 2 test level Compliance level Electromagnetic environment Conducted RF IEC 6100 4 6 3 Ver 150KHz 80MHz Not applicable Portable and mobile RF communications equipment are used no closer to any part of Meditech ABPM 05 including cables than the Recommended Separation Distance calculated the formula written below Recommended Separation distance d
13. abel however it is also strored electronically in the solid state memory of the evice On the front side of the housing there is the LCD the buttons of the device and a sticker displaying the name of the device The device can be connected to the serial or USB port of an IBM compatible PC with an optoelectronic interface which has its socket positioned on the opposite side from the cuff connector Patients can start extra blood pressure readings or mark symptomatic events Accessories m set one 1 plastic or carton packaging depending on order one 1 ABPM 05 recorder unit one 1 serial or USB interface unit with twin optical cable one 1 pouch for recorder with shoulder and waist straps one 1 normal adult size cuff four 4 AA rechargeable batteries one l battery charger one l Cardio Visions software CD one 1 user manual one 1 declaration of conformity m recorder package one 1 carton packaging one 1 ABPM 05 recorder unit one l pouch for recorder with shoulder and waist straps one 1 normal adult size cuff one 1 declaration of conformity Accessories may vary from place to place Using the buttons On the front side of the housing below the LCD you may find three buttons the START button is marked with a triangle the EVENT button marked by a heart and the DAY NIGHT button indicated by a half moon If the device is turned on then every button press is accompanied by a short beeping sound
14. as the oscillometric blood pressure measurement method is generally recommended for use only with special caution in patients with arrhythmias Parkinson s disease or other diseases with tremor Always consult a physician for the interpretation of the blood pressure measurements Note that any blood pressure recording may be affected by the body position the physiological condition of the patient and other factors Device type ABPM 05 described in this manual complies with the requirements of the EU Medical Devices Directive 93 42 EEC 0120 is the identifier 0120 of Notified Body SGS UK MDD Ila MDD classification Ila EMC class B EMC group 1 MDR According to Canadian regulations the device classification is MDR II II Medical Device Regulation of Canada Rule 10 1 of MDR SOR 98 282 13Mar2007 ABPM 05 is an internally powered type CF device Protection vs RP ingress of water none Mode of operation continuous The device is not protected against defibrillators or other high frequency surgical equipments The first four digits of the serial number of a recorder show the year of YYYY nnnnnn i 5 production The rest is the serial number This symbol shows that according to regulations ABPM 05 should be handled as electronic waste during rollout Blood pressure measurements determined with the algorithm of an Vv ABPM 05 recorder on adults are equivalent to those obtained by a trained observer using the c
15. ble an ABPM 05 recorder to perform 250 blood pressure measurements during a 24 48 hours long monitoring session If you opt to use alkaline batteries choose high capacity long life products to enable reliable operation A small crossed battery sign on the LCD shows low battery voltage In order to change batteries take the recorder out of the holder pouch and remove the battery compartment cover on the back side Place two properly charged high capacity AA rechargeable or two new long life AA alkaline batteries into the compartment as shown in the polarity drawing Close the compartment 15 Cuffs and their application It is advisable to wear a thin shirt or blouse under the cuff This does not influence the accuracy of blood pressure measurements but it prevents possible problems caused by long time wear sweating itching etc Place the cuff on the upper arm so that the rubber tube points towards the patient s shoulder and the bladder is placed above the brachial artery if possible Contrary to the usual placement with the tube pointing downwards the advantage is that the patient can wear a loose jacket over the cuff Connect the rubber tube of the cuff into the air plug connector which you can find on the long edge closer to the buttons of the ABPM 05 recorder Connect the cuff turning it clockwise with slight pressure Note It is recommended that the cuff be applied as tightly as acceptable for the patient A too loose cuff wi
16. eaning ABPM 05 ambulatory blood pressure recorders are not specially protected against spills or ingression of water or other liquids Do not immerse the recorder in water or any cleaning fluid and protect it from spills and splashes Do not expose it to heavy rain or steam and do not wear it in a wet environment e g shower bath or swimming pool In case of minor effects of a wet environment wipe off water drops with a dry cloth Keep the recorder in a normal dry room for at least one hour before use if condensation is suspected In case of ingress of water in the recorder remove batteries from the unit and refer the unit to authorized service Never place a recorder unit in a disinfecting or sterilizing machine A recommended means of cleaning is to wipe the recorder with a disinfectant cleaning tissue e g Henkel Ecolab Incides or a similar product Alternatively wipe with a slightly damp cloth then dry it with an antistatic tissue Do not expose recorders to extreme heat or radiation including long exposure to direct strong sunlight Regular checks warranty service Verification of pressure measurement accuracy is recommended biannually ABPM 05 recorders are covered by a two year warranty under general warranty conditions of Meditech Ltd see relevant section This warranty does not cover any malfunction or defects arising from improper use the use of inadequate accessories accident theft or use of the device outside operating envi
17. evice is switched off no other functions are available LCD check Press and hold the START button to light up all segments of the LCD to check if they all work correctly Battery voltage check Press and hold the START button for more than 5 seconds to display battery voltage on the LCD e g 2_ 64 equal to 2 64 V After checking the voltage please release the button because after additional 5 seconds the device may turn off The unit will then return to displaying time The voltage for fully charged accumulators should be over 2 5 V and for fresh alkaline batteries over 3 V Set a patient event marker The patient can mark any event without starting a manual blood pressure measurement by pressing the EVENT button briefly Typical causes for this use is taking medicine The patient should be instructed to record the reason for setting an event marker in a diary Mark time of going to bed and rising from bed If this function is disabled during programming the patient can press the DAY NIGHT button to mark the times of going to bed in the evening and rising from bed in the morning Manual DAY NIGHT shift If this function is enabled during the programming then the patient can manually shift the measurement frequency period day or night by pressing the DAY NIGHT button The shift is available in the two hour period before the prescheduled shift Display ABPM 05 will show important status information as well as the process and
18. hould mark events such as taking medication with the EVENT button marked with a heart They should also mark the time of going to bed and rising from bed with the DAY NIGHT button marked with a crescent moon They may interrupt any single blood pressure measurement if necessary by pressing any button Should the batteries run down during a monitoring session they can be simply replaced Monitoring will continue and data will not be lost Patients should never measure anybody else s blood pressure with an ABP recorder during an ambulatory blood pressure monitoring session Connecting the ABPM 05 recorder to the PC Please connect the optical interface which was delivered with the device to the serial RS232 9 pin connection or USB port of the PC The other side of the interface cable which is a two point plastic connection should be connected to the socket of the ABPM 05 in a way that the red plastic ring is directed to the lower side of the device 13 Start the CardioVisions software and open the Options menu then click on the Communication tab on the left side of the screen On the appearing window select ABPM 05 on the right side and then click on the Meditech USB or on the Serial port options dependent upon your interface In case of a serial port please provide the ID of the serial port COM port to which you connected the device If you are unable to do so then tick the Auto search com port option In order to check the co
19. itable for use in domestic RF emission establishments and in establishments CISPR 11 directly connected to the low voltage power supply network which supplies buildings used for domestic purposes Harmonic emission Not applicable IEC61000 3 2 Voltage fluctuations Complies ABPM 0S is suitable for use in Flickers establishments directly connected to a TEC61000 3 3 public low voltage mains network 18 Directive and declaration of manufacturer Electromagnetic immunity ABPM 05 is suitable for use in the specified electromagnetic environment The purchaser or user of Meditech ABPM 05 should assure that it is used in an electromagnetic environment as described below Immunity test IEC601 1 2 test Compliance Electromagnetic environment level level Electrostatic 6KYV contact 8KV air Floors are wood concrete or discharge ESD 48KV air ceramic tile or floors are IEC 61000 4 2 covered with synthetic material and the relative humidity is at least 30 percent Electrical fast 2KV for power Not Mains power quality is that of a transient burst supply lines applicable typical commercial and or IEC 61000 4 4 IKV for hospital environment input output lines Surge 1KV differential Not Mains power quality is that of a IEC 61000 4 5 mode applicable typical commercial and or DI common hospital environment mode Voltage dips lt 5 Ur F95 Not Mains power quality is that of
20. ll cause much longer blood pressure measurement times and possibly aborted measurements With an overly loose cuff the recorder must pump to tighten the cuff on the arm and then it must reach the pressure necessary for measurement This causes considerable inconvenience for the patient and results in less data for evaluation If the patient removes the cuff for a period during the monitoring session it should be re applied with appropriate tightness with help from another person if necessary Should blood pressure measurements cause bloodshots torpidity or pain in the hand the cuff should be removed from the arm and disconnected from the recorder Such occurrence should be reported to the physician at once but latest after the monitoring session Meditech ABPM 05 recognizes and functions with three different cuff sizes Please set the appropriate cuff size to be used during the programming of the device Attention inappropriate setting of the cuff size may lead to device malfunctioning which is inconvenient for the patient and may lead to an unsuccessful measurement Name Bladder Sleeve Arm circumference dimensions dimensions range Normal adult 12 5 x 22 5 cm 16 x 52 cm 24 32 cm Small adult child 6 x 28 5 cm 9x41 cm under 24 cm Large adult 14 5 x 32 cm 16 x 70 cm 32 42 cm When properly applied the end of the sleeve the one closer to the tube should fall in the indicated range The cuff is the component which by definition
21. mmunication please connect the device to the PC charged batteries device switched on in the above mentioned way and then click on the Test button If the communication was successful then the software will display the serial number and the firmware version of the device Monitoring step by step Before you begin you must have the CardioVisions software properly installed and configured on your computer and the recorder correctly connected To program your recorder you will need a Meditech optical interface cable properly connected to your computer s serial or USB port or to a USB port using a standard USB to serial converter and the communication port correctly selected in the CardioVisions software A successful monitoring session consists of the following steps Inform your patient about monitoring rules well in advance Start the CardioVisions program select the ABPM 05 recorder type Enter new patient data or select patient from the database Create a monitoring plan with respect to the patient s lifestyle aA BW NY Insert two fully charged AA size batteries into the battery compartment and check their voltage Connect the recorder to the computer Send the monitoring plan from the computer to the recorder unit Apply the cuff to the patient with the device placed in the pouch Oo OND Give the patient diary to the patient along with detailed instructions about the rules and the usage of the device
22. n or are removed Used batteries may fall under the category of hazardous waste and should be disposed of properly Important It is strongly recommended to use freshly charged accumulators or new batteries with every patient so that batteries do not run down during monitoring even in case of very high blood pressure values and or a long monitoring session After inserting batteries in ABPM 05 recorders it is advised to check their voltage before programming the recorders Do not start a new monitoring session with low batteries The typical voltage for two fully charged rechargeable batteries should be over 2 5 V and for fresh alkaline batteries over 3 V It is possible to check battery voltage with the START button Please check the Using the buttons section for more details Important If a recorder is not used for a long period the in built backup cell ensuring the operation of the internal clock may get discharged In this case keep freshly charged batteries in the recorder for at least one day this will recharge the backup cell It is possible to use the recorder afterwards If the backup cell is not properly charged the internal clock may work incorrectly and the recorder may not start measurements in due time Two sets of rechargeable batteries and a charger are by default included in the complete set Please refer to the relevant product descriptions when charging batteries A set of properly charged high capacity batteries will ena
23. on the computer Once the pre programmed time is reached the recorder will commence operating automatically and perform blood pressure measurements based on the monitoring plan To obtain reliable BP readings certain rules must be observed Rules of monitoring 1 10 Inform the patient about the goal and expected results of the monitoring Provide an event diary and rules to observe Patients can fit the recorder comfortably with the adjustable straps It is advisable to wear a thin shirt under the ABP cuffs This does not influence the accuracy of blood pressure measurement but it prevents problems caused by long time wear of the cuff sweat itching soreness etc The cuff should be properly placed and connected Patients should avoid excess movement during blood pressure measurements They should hold their arm loose slightly away from their chest Should the blood pressure measurements cause bloodshots torpidity or pain in the hand the cuff should be removed from the arm immediately and disconnected from the recorder Such occurrence should be reported to the physician latest after the monitoring session Patients should not remove the recorder even at night By loosening the straps they can avoid problems when turning in their sleep The recorder does not disturb most patients at night Patients may start extra blood pressure measurements with the START button of the ABPM 05 recorder marked with a triangle They s
24. ronmental specifications or intended measurement range Removing the closing label from the back side of the device voids this warranty There are no user serviceable parts inside Meditech recorders they contain high complexity electronic and fine mechanical components If you have any problems please refer the recorder to qualified service personnel Contact Meditech or your distributor for service information Roll out ABPM 05 recorders include an internal NiCd coin cell which may fall under the category of hazardous waste and should be disposed of properly The device should be handled at roll out as normal electronic waste 11 Safety concerns Electric shock hazard protection ABPM 05 recorders meet relevant shock hazard protection standards ABPM 05 recorders operate with two 1 5V AA batteries or two 1 2V AA rechargeable batteries This excludes all electric shock hazards even in the unlikely case of multiple device errors Use only standard long life alkaline batteries or standard NiCd or NiMH rechargeable batteries of the proper size Do not use lithium batteries Do not mix different battery types do not mix new and old batteries do not use damaged batteries Many personal computers do not meet certain shock hazard protection standards or strict safety regulations applicable to medical devices Therefore during the computer based use of Meditech recorders keep at least a 2 meter distance between patient and computer This is
25. t output power of the transmitter W 1 note in case of frequency 80MHz or 800 MHz the formula for the higher range is applicable 2 note These are guidelines Actual conditions may vary 21 Notes 22
26. the required minimum safety distance ABPM 05 recorders communicate using a plastic optical cable whose 4 m standard and up to 10 m optional length allows for the required safety distance The plastic optical cable ensures perfect electric separation and reduces the effects of external electric noise It does not conduct electricity Biocompatibility To avoid infection risks and for general hygienic reasons the device cuff and tubing should never contact the patient s skin directly Hazardous materials Used batteries qualify as hazardous waste and should be disposed of properly Meditech recorders do not contain any materials qualified as pharmaceutical substance or tissue of animal origin They emit no material hazardous to humans Risk of incorrect diagnosis The basic intended use of ABPM 05 recorders is to record blood pressure and pulse rate values Patients should be informed about rules of cooperative behaviour proper handling of the recorder used and expected results of monitoring in advance ABPM 05 recorders only provide data to support diagnostic decisions of a qualified physician they do not automatically provide a diagnosis of any kind During the evaluation of recorded blood pressure values possible artefacts due to external disturbances motion artefacts and electrical noise should be observed and handled with caution 12 Working with ABPM 05 The recorder must be programmed with the CardioVisions software installed
27. uff stethoscope auscultation method Korotkoff phase V within the limits prescribed by the American National Standard for Electronic or Automated Sphygmomanometers The algorithm used in the ABPM 05 similarly to the ABPM 04 also fulfills the requirements of the British Hypertension Society Validation Protocol for Automated Blood Pressure Measuring Devices a For information on cuffs and their application see page 17 Take care to avoid blocking the air flow in the tube of the cuff and twisting the tube Make sure the cuff and its tubing or the lead wires do not cause strangulation or a circulation problem Should the patient experience arm numbness or pain remaining after any blood pressure reading is completed the cuff should be removed to avoid permanent vascular or neural injury a No user serviceable parts inside Meditech recorders contain high complexity electronic and fine mechanical components If you have any problems please refer your recorder to qualified service personnel a File ID BP5E2211 This page is intentionally left blank Table of Contents Table of Contents 23 ssieaisn ou a A saad nieren t anon aig a A AN ETOO AaS Ro ii 5 Recommended use of ambulatory blood pressure recorderS cccccceesseeeteeeeteeetseeees 6 Meditech ABPM Srn innnan a a a a a gies 6 ACCESSO E Sudene deat e orea AAE A a la EEE e EA N EN ea 7 Usine theb ttonsi ssn eannan ea E tine a a a es 7 Display nres in ian a AE E A
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