ABPM 05 User Manual

Important information – precautions for use – read carefully! 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 fax: +36 1 282 9388

www.meditech.hu e-mail: [email protected]

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 Unit 202b, Worle Parkway Western-super-Mare, BS22 0WA

SGS Yarsley fax: +44 1934 522 137 www.sgs.com

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Meditech 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

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Though the blood pressure measurement algorithm used in Meditech ABP recorders 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.

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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)

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MDD IIa

MDD classification IIa. EMC class A. EMC group not applicable. Meditech ABPM-05 is an internally powered type CF device. Protection vs. ingress of water: ordinary. Mode of operation: continuous.

2006/5nnnnn

The first four digits of the serial number of a recorder show the year of 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.

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Blood pressure measurements determined with the algorithm of a 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 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 & al). For information on cuffs and their application, see page 11. 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. 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.

File ID: BP5B2210

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Table of Contents Table of Contents...5 Recommended use of ambulatory blood pressure recorders...6 Care and maintenance...6 Safety concerns...7 Working with ABPM-05...8 Rules of monitoring...8 Monitoring step by step...9 Batteries...10 Cuffs and their application...11 Meditech ABPM-05...12 Accessories...12 Using the buttons...13 Displays...14 Technical parameters...15 Meditech product warranty information...16 Notes...17

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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  Elderly patient  As a guide to antihypertensive drug treatment  Type 1 diabetes  Hypertension of pregnancy  Evaluation of hypotension  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 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.

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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 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 patient 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.

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Working with ABPM-05 The recorder must be programmed from the CardioVisions software installed 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. Inform the patient about the goal and expected results of the monitoring. Provide an event diary and rules to observe. 2. Patients can fit the recorder comfortably with the adjustable straps. 3. 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 longtime wear of the cuff (sweat, itching, soreness, etc.). 4. The cuff should be properly placed and connected. 5. Patients should avoid excess movement during blood pressure measurements. They should hold their arm loose, slightly away from their chest. 6. 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. 7. 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. 8. Patients may start extra blood pressure measurements with the START button of the ABPM-05 recorder, marked with a triangle. They should mark events 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. 9. Should the batteries run down during a monitoring session, they can be simply replaced. Monitoring will continue, and data will not be lost. 10. Patients should never measure anybody else’s blood pressure with an ABP recorder during an ambulatory blood pressure monitoring session.

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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. 3. Start the CardioVisions program, select the ABPM-05 recorder type for use. 4. Enter new patient data or select patient from the database. 5. Apply the cuff to the patient. 6. Connect the recorder to the computer. 7. Create a monitoring plan. 8. 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.

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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, 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 batteries 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. Please 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, longlife products to enable reliable operation. A small crossed battery sign on the LCD shows low battery voltage.

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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. 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 Normal adult Small adult (child) Large adult

Bladder dimensions 12.5 x 22.5 cm 6 x 28.5 cm 14.5 x 32 cm

Sleeve dimensions 16 x 52 cm 9 x 41 cm 16 x 70 cm

Arm circumference range* 24-32 cm under 24 cm 32-42 cm

* When properly applied, the end of the sleeve (the one closer to the tube) should fall in the indicated range.

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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 housing. 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 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. Accessories  set

one one one one one four one one one

(1) (1) (1) (1) (1) (4) (1) (1) (1)

alucase or carton packaging (depending on order) recorder unit serial interface unit with twin optical cable pouch for recorder, with shoulder and waist straps normal adult size cuff AA rechargeable batteries battery charger CardioVisions software CD user guide

 recorder package

one one one one

(1) (1) (1) (1)

carton packaging recorder unit pouch for recorder, with shoulder and waist straps normal adult size cuff

Accessories may vary from place to place.

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Using the buttons The START button is marked with a triangle, closest to the LCD. Its functions: 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. 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. 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).

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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 program. This helps service personnel to identify causes of an unexpected behavior, result or error. Two dashes: recorder switched off

LCD check: all segments are displayed

Normal status: time is displayed

Night mode: time is displayed, moon sign is lit

Communication with personal computer

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Setting zero pressure level for blood pressure measurement

Pumping for measurement current pressure [mmHg]

Heart symbol blinking in tune with pulse: measurement in progress

Systolic value of just completed measurement [mmHg]

Diastolic value of just completed measurement [mmHg]

Pulse rate value of just completed measurement [beats per minute]

Blood pressure measurement cancelled by pressing a button

Battery voltage display (2.37 V)

Error code display

Event marker set with buton

Technical parameters Power supply: Blood pressure measurement method: 2 AA rechargeable NiCd or NiMH batteries oscillometric or 2 AA alkaline batteries Blood pressure maximum storage: Display: over 600 measurements liquid-crystal Pressure measurement range: Data storage: 0-300 mmHg internal solid state memory Static accuracy: Data transmission: ± 3 mmHg or ± 2% of measured value on serial optical cable, 115200Baud (stability: 2 years) PC interface: Blood pressure measurement range: special optoelectronic serial interface 30-260 mmHg with 9 pin Canon RS232 connector Blood pressure measurement accuracy: Operating environment: the BP measuring algorithm has been BHS+10 to +45 °C of temperature validated in Meditech ABPM-04 device 10 to 95 % humidity, non condensing Pressure sensor: 70 to 106 kPa atmospheric pressure piezo-resistive Storage conditions: Inflation: -20 to +50 °C of temperature automatically controlled pump 10 to 95 % humidity, non condensing Safety: Size: maximum inflation 300 mmHg; 70 x 99 x 30 mm independent safety release valve Weight: Deflation and rapid air release: app. 240 g (batteries included) automatic pressure release valve

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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, 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, 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 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.

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Notes

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