User guide for Meditech ABPM-05
Contents
1. Note It is recommended that the cuff be applied as tightly as acceptable for the patient A loose cuff will 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 latest after the monitoring session Meditech ABPM 05 recognizes and functions with three different cuff sizes Name Bladder Sleeve Arm circumference dimensions dimensions range Normal adult 12 5 x 22 5 cm 16x 52 cm 24 32 cm Small adult child 6 x 28 5 cm 9x 41 cm under 24 cm Large adult 14 5 x 32 cm 16x 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 11 Meditech ABPM 05 The ABPM 05 device is a compact lightweight monitoring unit typically worn by the patient for 24 hours It has a battery compartment and a rating label on its back housi2. 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 Care and maintenance Protection and cleaning 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 including a shower bath or swimming pool 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 Meditech 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 accident theft or use of the device
3. Cancel a blood pressure measurement The patient can interrupt a blood pressure measurement by pressing either button at any time while the cuff is pressurized 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 The EVENT button is in the middle marked with a heart Its function 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 waking up going to sleep taking medicine The patient should be instructed to record the reason for setting an event marker in a diary The DAY NIGHT button is farthest from the LCD marked with a moon Its function Mark time of going to bed and rising from bed If this function is enabled 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 13 Displays ABPM 05 will show important status information as well as the process and 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 pr
4. 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 d 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 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 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 esp
5. 0 to 95 humidity non condensing 70 to 106 kPa atmospheric pressure Storage conditions 20 to 50 C of temperature 10 to 95 humidity non condensing Size 70 x 99 x 30 mm 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 Blood pressure measurement accuracy the BP measuring algorithm has been BHS validated in Meditech ABPM 04 device 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 15 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 b 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
6. Automated Sphygmomanometers The algorithm also fulfils the requirements of the British Hypertension Society Validation Protocol for Automated Blood Pressure Measuring Devices algorithm used in all Meditech ABP recorders is identical to that used in the Meditech ABPM 04 device which received grade B for both systolic and diastolic accuracy validation study published in Blood Pressure Monitoring 1998 3 6 363 8 by I Barna amp al M Blood pressure measurements determined with the algorithm of a For information on cuffs and their application see page 11 a Take care to avoid blocking the air flow in the tube of the cuff 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 o 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 BP5B2210 This page is intentionally left blank Table of Contents PADIS OL Contado 5 Recommended use of ambulatory blood pressure recorderS oooooonoccnnoccnocaconccconccconccnn 6 Care ANd AAI A TE 6 Safety COMC ETS oo E bac ate sell a sued aed a 7 Working with ABP MO A AA 8 Rules of monitoring ienn E
7. Meditech 000 eet ambulatory blood pressure monitor UK Distributor P M S Instruments Ltd Tel 01628 773233 www pmsinstruments co uk Important information precautions for use read carefully A Meditech 009 ee o a a 0120 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 hu fax 36 1 282 9388 e mail meditech meditech hu 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 Western super Mare BS22 OWA www sgs com Meditech ABPM 05 recorders should not be used if any of the following cases apply e patients without an indication for ambulatory blood pressure monitoring non cooperative patients e patients in any way unable to operate a recorder as intended e patients requiring urgency emergency cardiac care e unconscious or otherwise incapable patients e patients with serious mobility impairments without supervision e patients with coagulation disturbances e children without supervision e children under the age of 8 years Though the blood pressure measurement algorithm used in Meditech ABP recorder
8. a a a a 8 Monitoring Step DY SD n aaa aaea e Ae E EE EERE AE E aA EEA 9 A 10 Cutts and their APPMCAU OM edi tiroides 11 Meditech ABPM 05 ii A A a 12 PRICES SENS S es oases sate sone S cyte a A teas an T sates 12 Usme th buttons caneiro A A 13 A O 14 Technical Parametros 15 Meditech product warranty information ss seseseesseeeseessressressressressressressresssesseessers 16 DN LCS E no 5 E E O 17 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 m Suspected white coat hypertension m Suspected nocturnal hypertension m To establish dipper status m Resistant hypertension m Elderly patient m As a guide to antihypertensive drug treatment m Type 1 diabetes m Hypertension of pregnancy m Evaluation of hypotension m 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
9. atteries since they may run down due to the constant small power consumption of the integrated circuits of the device Data in the recorder is not lost even if batteries run down 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 recorder 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 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 main batteries in the recorder for at least one day this will recharge the backup cell It is possible to use the recorder normally in the meantime 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 P
10. 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 l 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 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 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 should mark event
11. ecially 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 a 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 16 Notes 17
12. lease refer to the relevant product descriptions when charging batteries A set of properly charged high capacity batteries will enable an ABPM 05 recorder to perform 250 300 blood pressure measurements during a 24 48 hour long monitoring session 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 rechargeables or two new long life AA alkaline batteries into the compartment as shown in the polarity drawing Close the compartment 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 10 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 shirt or blouse 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
13. ng The serial number is placed on the rating label It is also stored electronically in the solid state memory of the device On the front housing there is the memos LCD the buttons of the device and a sticker displaying the name of the device The cuff connector is located on the side ABPM 05 operates with two AA size accumulators or batteries The device can be connected to the serial port of an IBM compatible PC with an optoelectronic interface whose socket is positioned on the opposite side from the cuff connector The recorder is easily initialized connected to a personal computer using an optical cable link Patients can start extra blood pressure readings or mark symptomatic events Meditech Sa le Accessories m set one 1 alucase or carton packaging depending on order one 1 recorder unit one 1 serial 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 1 battery charger one 1 CardioVisions software CD one 1 user guide m recorder package one 1 carton packaging one 1 recorder unit one l pouch for recorder with shoulder and waist straps one 1 normal adult size cuff Accessories may vary from place to place 12 Using the buttons The START button is marked with a triangle closest to the LCD Its functions Manual blood pressure measurement If it seems necessar
14. ogram This helps service personnel to identify causes of an unexpected behavior result or error Two dashes y 3 LCD check o recorder switched off ll Be E all segments are displayed _ _ Normal status 2 _ 2 Night mode Hh ec 4 time is displayed e Hts El time is displayed moon sign is lit p r A L Communication with dd personal computer _ Setting zero pressure 4 Pumping for Lt HH level for blood pressure m ta f measurement measurement a current pressure mmHg v _ _ Heart symbol blinking E _ Systolic value of just ta a in tune with pulse tof ta completed measurement Z measurement in progress mmHg _ _ Diastolic value of just een sia Pulse rate value of just a e completed measurement p El E completed measurement E mmHg beats per minute Blood pressure Battery voltage display mee a a Lie pr measurement cancelled est 2 37 V by pressing a button Error code display Event marker set with E e buton 14 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 optical cable 115200Baud PC interface special optoelectronic serial interface with 9 pin Canon RS232 connector Operating environment 10 to 45 C of temperature 1
15. outside operating environmental 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 Meditech recorders may include an internal NiCd coin cell which may fall under the category of hazardous waste and should be disposed of properly All other parts of should be handled at roll out as normal electronic waste Safety concerns Electric shock hazard protection Meditech 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 pa
16. r Create a monitoring plan Send the monitoring plan from the computer to the recorder unit 9 Give detailed instructions to the patient who has to wear the recorder Monitoring session typically 24 hours 10 Check if the plan is completed 11 Remove the unit and cuff from the returned patient 12 Ask for the patient diary and ask the patient for any events symptoms observations or complaints 13 Start the CardioVisions program and select the ABPM 05 recorder type for use 14 Transfer collected data from the recorder to your database 15 Analyze blood pressure profile 16 Create and print a report 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 lithtum 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 for they may contain acidic electrolytes which may leak and corrode electronic components Never use batteries damaged in any way Should the batteries still 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 b
17. s has been tested and 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 Always consult a physician for the interpretation blood pressure measurements Note that any blood pressure recording may be affected by body position the physiological condition of the patient and other factors Meditech ABPM 05 described in this manual complies with the requirements of the EU Medical Devices Directive 93 42 EEC 0120 is the identifier of Notified Body SGS Yarsley MDD Ila MDD classification lla EMC class A EMC group not applicable Protection vs ingress of water ordinary Y Meditech ABPM 0S is an internally powered type CF device Mode of operation continuous The first four digits of the serial number of a recorder show the year of 2006 5nnnnn production The number 5 following the slash serves as device type identifier The rest is the actual serial number This symbol shows that according to regulations ABPM 05 should be handled as electronic waste during rollout Meditech ABP recorder on adults are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method Korotkoff phase V within the limits prescribed by the American National Standard for Electronic or
18. s such as taking medication waking up or going to sleep with the EVENT button marked with a heart They should 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 Monitoring step by step Before you begin you must have the CardioVisions program 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 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 1 Inform your patient about monitoring rules well in advance 2 Insert two fully charged AA size batteries into the battery compartment and check their voltage Start the CardioVisions program select the ABPM 05 recorder type for use Enter new patient data or select patient from the database Apply the cuff to the patient Connect the recorder to the compute
19. tient and computer Meditech 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 may 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 or energy hazardous to humans Risk of incorrect diagnosis The basic intended use of Meditech 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 Working with ABPM 05 The recorder must be programmed from the CardioVisions software installed on the
20. y 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 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 While the recorder is switched off normal functions are not available The recorder can only be switched on manually 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 device 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 The voltage display lasts until you release the button but not more than 5 seconds 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
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