How the Diasys Integra II functions
Contents
1. systematically when new batteries are used for the first time at least once a year if the batteries are not in regular use If the battery has been stored out of the charger for more than two weeks since last being charged 5 1 4 End of charge When the green light is on the battery is ready to be used and can be removed for storage or left in the charger until required Caution if a charged battery is removed from the charger and not used for more than two weeks we recommend that it be recharged again in case it has discharged itself Ss Do not leave a battery in the charger if it is not plugged into the mains it will quickly lose its charge Do not leave the charger plugged into the mains unnecessarily Do not leave a charged battery in a charger plugged into the mains for a long period of time Do not start a recording using a battery only part charged the unit may stop during the recording BEN 18 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring 9 2 Inserting the batteries into the recorder 5 2 1 Insertion Slide the battery cover off and if there is already a battery in the unit remove it Insert a recharged battery into the unit taking care not to invert the polarities E Slide the cover towards the outside The arrow on the battery should be pointing towards the bottom of the compartment as shown below If it is difficult to insert the batte2. The Diasys Integra II unit weighs about 195g and contains the electronic system and pneumatic inflation module It is linked to the patient s cuff with a tubing system The measurements made by the Diasys Integra II can be printed out directly in report form by a dedicated printer connected to the unit If a computer is used recording conditions and criteria can be fixed and the results of the procedure can be selected organised stored and printed out in a fully customised report BEN 4 Diasys Integra II Manual GB Revision 4 2 Guarantee 2 Guarantee NOVACOR undertakes to deliver merchandise in compliance with the technical specifications mentioned and to replace any merchandise recognised as being defective 2 1 Specific guarantees concerning units Each unit possesses its own specific serial number which identifies it NOVACOR guarantees the unit for a period of one year from the date of delivery against any defect resulting in an abnormal function of the unit 2 2 Specific guarantees concerning accessories Equipment which is not an integral part of the unit in particular the accessories and cables are not covered by the guarantee Cables with serial numbers are guaranteed for three months 2 3 Restrictions of the guarantee The guarantee does not apply to 1 units repaired or opened up outside our workshop 2 units damaged by negligence by accident or because the instructions
3. customers if required A Warning Only devices complying with IEC950 standards can be connected 8 9 Others precautions of use e Some particular physiological characteristics of the patient such as ausculatory gaps severe arrhythmia mainly Atrial Fibrillation pregnancy could influence the reliability of the measurement For specific limitations in ECG Gated Auscultatory Mode please refer to 5 4 4 However in presence of common arrythmia such as Atrial or Ventricular Premature beats or runs the device is able to operate properly The BP recording could also be influenced by the position of the patient 48 Diasys Integra II Manual GB Revision 4 8 Precautions of use q This equipment must be used by qualified medical personnel trained in its use The patient should be informed about possible malfunctions of the unit particularly regarding the cuff inflation excessive or frequent inflations permanent pressure in the cuff their resulting potential hazards ecchymosis haematoma arm pain and how to avoid them by either stopping the current measurement by briefly pressing on the green key stop or stopping the recording holding the green keydown The device is not intended to be used on children under 12 years old particularly not on neonates Additional precautions of use can be found in this manual about use of the battery charger and NimH batteries 5 1 1 5 1
4. pacemakers functioning in the AAI DDD or associated modes Only VVI VVIR or VDD pacemaker patients would benefit from ECG gating 5 4 4 1 Index of arterial distensibility QKd Using the ECG cable also enables the QKd interval a true index of arterial distensibility to be measured The QKd interval is the time between the onset of the QRS complex and detection of the last Korotkoff sound at the level of the humeral artery during indirect measurement of the blood pressure This interval is dependant mainly on the pulse wave velocity Measuring the QKd interval rather than pulse wave velocity has the advantage of being automatic rapid simple and reproducible 30 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring The QKd interval is significantly reduced in hypertensive patients compared to normotensive patients of the same age and is therefore a simple method for estimating their arterial distensibility Measurement of the QKd interval and its clinical analysis can only be carried out if the QKd option of the DiasySoft or HolterSoft software has been installed 5 4 5 Position sensor An optional feature of the Diasys is a system enabling the unit to detect the patient s position at any given time vertical awake or horizontal resting in particular during measurements The patient s position is indicated next to each measurement both on the Diasys display screen and on the printed rep
5. after direct transmission to a printer EN Connecting the Diasys to a printer or a computer requires different cable links Ask your distributor for details 7 2 Modem Transmission This function allows the automatic transmission of the whole test in progress to a remote computer via a modem To continue with the recording restart the unit cf chapter 6 1 This requires a Diasys Integra II the number to be called reception modem entered in the DiasySoft communication window version 4 5 or above during programming a modem that can call out must be given to the patient with the Diasys a Diasys modem cable a Computer with a reception modem the reception computer must be on and the NovaModem tele reception module open and waiting reception 42 Diasys Integra II Manual GB Revision 4 7 Reading the recordings The modem must be plugged into the mains and the telephone socket before transmission Simply connect the Diasys to the modem using the specific cable to automatically initiate transmission MOD is displayed during transmission replaced by GOOD at the end of a successful transmission If COMM is displayed check that the modem is plugged in and switched on If the messages Er26 Er27 or COMM are displayed disconnect the Diasys from the modem turn off and switch back on the modem reconnect the Diasys to the modem to trigger a new transmiss
6. side of the slot into which the battery is placed The RED light indicates that the charger is working correctly when it is plugged into the mains outlet fixed light low brightness that the battery is being discharged when discharge prior to charge has been programmed see chapter 5 1 3 blinking light normal brightness that the battery is being charged fixed light normal brightness The GREEN light indicates that the operation is finished and the battery is charged Oo O Diasys Integra II Manual GB Revision 4 15 The back panel base A selector 2 red switches determines the charge mode It is advisable not to change the position of these switches It is however possible to implement an immediate charge by changing the position of Switch 1 SWITCH 1 ON Discharges the battery before recharging it factory setting SWITCH 1 OFF Immediate charge Whichever mode is chosen the green light comes on when the battery is charged indicating that it is ready to be used The position of switch 2 should never be changed and should always remain in the position shown above Never use the charger with any batteries other than those supplied by NOVACOR External power sources must comply with electrical safety EN 60 601 standards 16 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring 5 1 2 The battery The Diasys Integra II is delivered with two re
7. 2 5 1 3 5 1 4 and 5 2 1 use and positionning of the cuff 5 4 2 and 5 4 3 use of ECG gated auscultatory mode on patients with pacemaker 5 4 4 recommandations to the patients 6 2 8 10 Physical specifications 93 mm 63 mm 27 mm Weight with batteries 195 g approx Storage temperature 20 C 50 C Functioning temperature 0 C 50C 0 C 50C Do not store the batteries at over 45 Diasys Integra II Manual GB Revision 4 49 8 11 Technical specifications recorder type pressure holter measurement mode auscultatory ECG gated auscultatory oscillometric recording length up to 48 hrs maximum measurements 200 measurement precision 3 mmHg deflation levels auscultatory 3 to 7 or mmHg oscillometric 8 mmHg Signal input output type type RS 232 measurement ranges systole 50 260 mmHg diastole 30 180 mmHg mean 40 220 mmHg heart rate 240 30 min in ausculatory mode 240 40 min in oscillometric mode Complies with EIA 232 E standard 50 Diasys Integra II Manual GB Revision 4 Diasys Integra Il English gt Accessories Accessory Part number Diasys Integra Il DII 0001 00 Battery ACC 0750 00 Battery charger CHG 0001 00 UK battery charger CHG 0002 01 ECG cable with position sensor ACC 0101 00 Orthostati
8. 8 100 109 28 83 20 15 A nc IK 96 60 72 36 80 20 30 Osc XK 81 62 68 19 81 20 45 A nc mK 92 62 72 30 75 21 00 osc X4 96 64 75 32 78 21 15 A nc mK 89 64 72 25 83 Conclusions Conclusions SchluBfolgerungen Conclusioni Conclusiones Conclus es Example of a report using the position sensor M Diasys Integra II Manual GB Revision 4 Preparing for monitoring jeb uoz puna ejeb euoz puna __ gt OH AT OM _ ac ang ISLIP ye punos 1101010 e Jo uonoejeg 9A9 otjojseip ye punos JJ0X1010M e JO uonoejeq xejduioo SHH e Jo uonoejeg xe jduioo SHO e Jo uonoejeq Jeuueuo lojeynosny jeuueuo 5253 Diasys Integra II Manual GB Revision 4 33 DIASYS How the unit functions 6 1 Startu M P Mode selector in Measurement position Before putting the Diasys in its pouch check that the mode selector is in the MEASUREMENT position and that the unit is not connected to a terminal which would be indicated by COMM on the display To start up the unit keep the pink key pressed down and release it after the 4th beep One of the following messages will be displayed for 10 seconds Battery replaced since previous start up Battery not replaced since previous start up battery should be changed 6 How the unit functions Press the pink key brief
9. Kd option are used T ccu 38 Diasys Integra II Manual GB Revision 4 IS 6 How the unit functions Display of measurements can be cancelled using the DiasySoft ou HolterSoft software 6 8 Stopping measurements For safety and comfort reasons it is possible to interrupt a measurement or the monitoring as follows To stop an ongoing measurement TS press the green key briefly Stop Z 1 7 Rec Error 17 will be displayed Q C r l see the display table overleaf Select m all Monitoring can be stopped at any time by holding the green key down u Ca nm Ree you will hear a series of beeps NM a n Q STOP will be displayed Select she all No more measurements can be made until the pink key has been pressed Pressing the pink key will trigger two test measurements and the recording will continue normally 6 9 Display codes As well as the display of the functioning mode any problems occurring during a measurement are indicated by the display of an error code see overleaf which is also noted as such on the printed report if the software is not used If the DiasySoft or HolterSoft software is used these problems will be detailed both on the computer screen and on the report Diasys Integra II Manual GB Revision 4 39 Display Meaning Comment AUSC X Auscultatory mode OSCI Oscillometric mode AUTO Automatic mode COMM Communication established with print
10. TM NOVACOR Diasys Integra Il Manual English NOVACOR SA 4 passage Saint Antoine 92508 Rueil Malmaison Cedex France CC Diasys Integra II Manual 2005 NOVACOR SA All rights reserved 1 Introduction 4 2 Guarantee 5 2 1 Specific guarantees concerning units 5 2 2 Specific guarantees concerning accessories 5 2 3 Restrictions of the guarantee 5 2 4 Responsibilities 5 2 5 Upgrades 6 2 6 Copyrights 6 3 How the Diasys Integra Il functions 7 3 1 Auscultatory mode 8 3 2 Oscillometric mode 8 3 3 Automatic mode 8 3 4 BP Measurement accuracy 9 4 Description of the equipment 10 Diasys and standard accessories 10 Main optional accessories 10 4 1 The Diasys Integra Il recorder 11 4 2 The battery charger 12 4 83 The cuff and the air electric double tubing for connection to the Diasys Integra ll 13 5 Preparing Diasys Integra Il for monitoring 14 5 1 Preparing the battery 15 5 1 1 The battery charger 15 5 1 2 The battery 17 5 1 3 Charging the battery 17 5 1 4 End of charge 18 5 2 Inserting the battery into the recorder 19 5 2 1 Insertion 19 5 2 2 Safeguard battery non rechargeable lithium 20 5 3 Programming the Diasys Integra II 20 5 3 1 Programming the time 21 5 3 2 Programming the date 22 5 8 3 Programming intervals 23 5 4 Placing the cuff on the patient 24 5 4 1 The standard cuff 24 5 4 2 Recommandations for positionning the cuff 26 2 Diasys Integra II M
11. anual GB Revision 4 Summary 5 4 3 Changing arm 28 5 4 4 Setting up the ECG system 28 5 4 4 1 Index of arterial distensibility QKd 30 5 4 5 Position sensor 31 5 4 5 1 The ECG cable integrated position sensor 31 5 4 5 2 The orthostatism cable integrated position sensor 31 6 How the unit functions 34 6 1 Startup 34 6 2 Test measurements 35 6 3 Manually activated measurements 37 6 4 Palliative measurements 37 6 5 Suspend mode 37 6 6 Measurements which are not memorised 38 6 7 Display of measurements 38 6 8 Stopping measurements 39 6 9 Display codes 39 7 Reading the recordings 41 7 1 Transmission to a PC or a printer 41 7 2 Modem transmission 42 8 Precautions of use 44 8 1 Handling the equipment 44 8 2 Cleaning the equipment 44 8 3 Maintenance 45 8 4 Calibration test 45 8 5 Replacing the safeguard battery 46 8 6 Storage and dispatching 47 8 7 Preventative maintenance 47 8 8 Electrical safety standards 47 8 9 Others precautions of use 48 8 10 Physical specifications 49 8 11 Technical specifications 50 Oo O Diasys Integra II Manual GB Revision 4 3 1 Introduction The Diasys Integra II is a non invasive ambulatory system for measuring and recording blood pressure As well as measuring the systolic diastolic mean blood pressure and heart rate it can also in its most advanced version indicate patient position and calculate the index of arterial distensibility QKd
12. asys protective pouch and belt Main optional accessories battery charger ECG cable with position sensor single use cuff protectors DiasySoft or HolterSoft software customised according to the programming options required and the user s language and access key printer Diasys Printer or Diasys Computer link cable Diasys Modem link cable 4 Description of the equipment a 4 1 The Diasys Integra Il recorder Mode selector M measurement P program P mode display switched on On and validation of options Valid M mode monitoring started and activation of a manual recording Rec Electric connector Air connector L_ ECG cable and position sensor connection RS232 connector for printer ordinateur or modem P mode next choice Select M mode stop measurements Stop Ooo O Diasys Integra II Manual GB Revision 4 11 Battery cover 42 The battery charger 12 V direct current Red light power low brightness charging normal brightness discharge blinking Green light end of charge batteries ready to use Battery slot The Diasys functions exclusively with a high capacity rechargeable battery NiMH making it economical and environmentally friendly Batteries are recharged with a fast battery charger specially designed for the Diasys to ensure optimum performance and long life The charger is connected to the mains out
13. chargeable Nickel Metal Hydride NiMH batteries ref D10 1000 These batteries have been specially developed for the Diasys series and can be recharged about 500 times if used according to the recommendations in this manual A Precautions to be taken with the batteries Take care not to invert the polarities Do not store over 45 C Do not exceed the recommended recharge time otherwise the unit risks stopping during a recording Do not store charged or discharged batteries in the unit 5 1 3 Charging the batter Plug the charger into a compatible mains outlet check carefully that the voltage marked on the charger transformer corresponds to the voltage of your mains supply The red light will come on immediately with O low brightness Place the battery in the charger taking care to match the and signs on the battery with the same signs on the 2 charger Insert the battery into its slot Oo O Diasys Integra II Manual GB Revision 4 17 When the battery is placed in the charger the red light will become brighter and will either be fixed immediate charge mode or blinking discharge before recharge mode Duration of charge cycle without prior discharge about 1 hour maximum with prior discharge discharge up to 1h30 charge about 1h Sy Do not use any charger other than the one supplied by Novacor to recharge Diasys batteries Go through the charge cycle
14. described here Software programming operations are fully explained in the corresponding DiasySoft or HolterSoft manual We recommend that a recharged battery be inserted before each new programming operation If the battery is run down the Diasys will display the message Er 14 If it is dead the unit s keys will be blocked safeguard mode EN During programming if the selector or the two programming keys are not used for a certain time the screen will switch itself off to save battery power Press one of these two keys to retrieve the time screen 20 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring 5 3 1 Programming the time Press Valid to display the time Press Select and the first digit will flash Press Select to obtain the correct digit Press Valid to confirm The second digit will flash Adjust the second digit and press Valid to confirm The AM PM setting will flash Press Valid to make AM flash If PM is required press Select then Valid Adjust the two minute digits as above Stop TO On Select Valid When the last digit has been validated si all four digits will flash Press Valid to 77 MAL Reg confirm the time The date will be m 11 mt 7 m Q displayed Select s gt On FLT Valid Note that the AM PM setting is only proposed if the time is programmed before midday Diasys Integra II Manua
15. e a year in order to avoid any loss in performance 8 5 Replacing the safeguard batter The lithium safeguard battery is indispensable to the proper functioning of the Diasys Integra II When it is completely run down the message LITH is displayed see chapter 5 2 2 It can only be replaced in an authorised workshop Should this message be displayed contact your distributor who will know the procedure to follow 46 Diasys Integra II Manual GB Revision 4 8 Precautions of use q 8 6 Storage and dispatching Remove the battery if the Diasys is to be stored for several days without being used The Diasys Integra II and the battery charger are delivered in a protective packaging Check that the unit is intact before use bad transport conditions could damage unit performance Keep all packaging should the unit need to be transported at a later date Store the recorder and all its accessories in the recommended storage conditions 20 C 50 C otherwise its performances could be degraded 8 7 Preventative maintenance A preventative check up of the unit and cuffs is recommended every two years This check up will reduce the number of potential break downs and prolong its useful life The unit will be checked for correct functioning in particular the pressure measurement circuit The check up must be carried out in our workshop or by an approved distributor The invoicing covers the tests only the quote fo
16. egra II Manual GB Revision 4 re E How the Diasys Integra Il functions The Diasys Integra II is a non invasive automatic ambulatory blood pressure recorder It has two standard modes of operating the Auscultatory mode and the Oscillometric mode The required mode is selected with the DiasySoft or HolterSoft software If neither of these modes has been specifically programmed the Diasys Integra II will choose the most appropriate mode for the patient according to its own criteria this is the Automatic mode 3 1 Auscultatory mode The auscultatory method is based on detection of the appearance and disappearance of Korotkoff sounds using a microphone which is usually placed over the humeral artery of the patient s left arm When the Diasys Integra II is in the auscultatory mode it can benefit from ECG gating which by opening a gate after detection of the QRS complex increases the accuracy of measurements made in an artefacted environment very active patient for example The R wave of the cardiac systole QRS is detected in board in a single channel ECG cable ECG gating enables the QKd interval a true index of arterial distensibility to be calculated The QKd is defined as the interval between the onset of the R wave and detection of the associated Korotkoff sound corresponding to the last Korotkoff sounds before diastolic pressure 3 2 Oscillometric mode The oscillometric mode is based on analysis
17. ents are never included in the statistical analysis They are however printed on the report and identified as being test measurements 36 Diasys Integra II Manual GB Revision 4 6 How the unit functions If there is no specific programming the standard increments are 5 of pressure in the cuff in the auscultatory mode and 8 mmHg in the oscillometric mode It is important to tell the patient that his cuff arm must remain still during measurement This will reduce the measurement time for extra comfort It will also reduce the risk of errors due to artefacts 6 3 Manually activated measurements The pink key enables manual measurements to be triggered whenever required Measurements activated by pressing the red key are carried out in the unit s operating mode The next pre programmed measurement will be cancelled if it is due to occur less than 2 minutes later 6 4 Palliative measurements If a measurement is defective a palliative measurement will be triggered 2 minutes after the beginning of this defective measurement and at least 30 seconds after the end A palliative measurement will not however be made if the interval between 2 pre programmed measurements is less than 5 minutes Manual and palliative measurements do not disrupt the sequence of the pre programmed measurement intervals iS Palliative measurements are systematically carried out in the oscillometric mode If 5 consecutive measu
18. er or computer MOD Communication established with modem GOOD Modem transmission successful STOP Manual stopping of monitoring Stop key held down TEST Calibration test Er 01 Defective solenoid valve Transitory electrical problem If problem continues contact your distributor Er 02 Auto Calibration impossible Residual pressure in cuff Check air tubing If problem continues contact your distributor Er 03 Abnormal inflation Tubing disconnected bent pierced or blocked or cuff too loose Check the air tubing and connector and that the cuff is properly wound around patient s arm Er 04 Measurement not validated Diastole lt 50 mmHg not confirmed Er 05 Abnormal pressure variation Muscular contraction or excessive exercise Bladder or air tube leakage Er 07 Excessive measurement time Measurement time 120 s Er 09 Excessive cuff pressure gt 205mmHg Er 10 Excessive noise or artefacts Interference on signal measurement impossible Er 11 Systolic pressure lt 50 mmHg No Konotkoff sounds Check the position of the microphone in the cuff and on the arm Er 12 Diastolic 30mmHg Er 13 Microphone not detected Not connected or wire broken Er 14 Battery run down Er 16 Stopped by connection Recording stopped because cable link connected to Diasys Er 17 Measurement stopped manually Stop key pressed during measurement Er 18 Stopped by switching mode select
19. he date and the year Or press Select to reprogram just the year 22 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring 5 3 3 Programming intervals The daytime sun and night time 4 Stop moon images are displayed alternately next to the corresponding intervals Select Press Select and the daytime interval Stop will flash Q Select Press Select to adjust the daytime Stop interval Q Press Valid to confirm the daytime interval The night time interval will p flash O Select Press Select to adjust the night time Gin interval Q Select Press Valid and the new intervals will flash alternately Press Valid to end the programming The time screen will be displayed Select Stop The following intervals are available Intervals in minutes A s Py ue daytime 2 3 4 5 6 10 15 20 30 45 60 night time 10 15 20 30 45 60 Sy When the selector is in the programming mode press the pink key On Valid if you wish to scan the unit s program Time Date Year Measurement intervals Diasys Integra II Manual GB Revision 4 23 5 4 Placing the cuff on the patient Fig 1 Patient equipped with Diasys and cuff 5 4 1 The standard cuff Locate the path of the humeral artery ideally with a stethoscope about 2 cm above the crease of the elbow Clean the inside of the arm and apply a
20. in the user manual have not been correctly followed If necessary contact your distributor or our maintenance service We do not accept units which have been returned without prior agreement 2 4 Responsibilities NOVACOR will not under any circumstances be held responsible for physical or material damage of whatever nature arising either directly or indirectly from improper use of the unit or from failure to follow the instructions in the user manual Although NOVACOR manufactures products to the highest standards it cannot guarantee or be held responsible for the validity or accuracy of the measurements made by its units Therefore connection of the unit interpretation of the ensuing clinical results and the diagnosis established from them are the entire responsibility of the physician Diasys Integra II Manual GB Revision 4 5 2 5 Upgrades All customers duly registered with NOVACOR or where applicable with one of its distributors will be kept informed to the best of NOVACOR s ability of any upgrades to the Diasys Integra II as they become available 2 6 Copyrights Diasys Integra II manual 2005 NOVACOR S A All rights reserved Diasys Integra II DiasySoft HolterSoft and their respective logos are registered trademarks of NOVACOR S A Macintosh is a registered trademark of Apple Computer International Windows is a registered trademark of Microsoft Corporation BEN 6 Diasys Int
21. ion If the problem continues the caller should check with the receiver that everything is in order at his end computer with modem and NovaModem open awaiting reception After transmission the monitoring can continue by simply pressing the pink key the unit carries out two test measurements BEND Diasys Integra II Manual GB Revision 4 43 DIASY gt Precautions of use 8 1 Handling the equipment Do not use your nails or a sharp object when pressing the programming keys The design of the Diasys exterior air connector is such that it cannot be made waterproof The unit should not be exposed to dust or humidity and great care must be taken to ensure that it is never sprayed with or immersed in water 8 2 Cleaning the equipment Clean the Diasys the cuff s air electric tube and the ECG cable regularly with a soft cloth lightly moistened with alcohol or a cleaning product not containing solvents or detergents Avoid all contact with liquids To ensure optimal hygiene clean the cuff cover in soapy water after each patient by hand or in a washing machine delicate cycle 30 40 C 8 Precautions of use 8 3 Maintenance Maintenance is carried out in our workshop as rapidly as possible We are unable however to provide a unit on loan during the repair period or to provide compensation of any Sort In all cases including units under guarantee transport costs are the cus
22. l GB Revision 4 21 5 3 2 Programming the date Press Select to choose the date format dd mm or mm dd PUE i ot 7 Reg Q Bu On Select Valid Press Valid to confirm The first digit will flash stop v Rec de e On Select 1 Valid Press Select to obtain the correct digit Stop Vom Rec wheres Q Select ya Y I c On Ce Valid Press Valid to confirm The second digit will flash 961 LE IC y e On Select 1 Valid Adjust the other digits as above Sl z 3 i i an oe ec Press Valid to confirm O Li s cm amo a On Select D Valid When the last digit has been si AER Faz confirmed all four digits will flash y NON 7 Rec Press Valid to confirm the date O m 11 W 1 1 4 The year will be displayed Select sa a o em a On CCl nu y Valid Press Select until the year is correct and press Valid to confirm Stop m mJ Rec 2000 O emp On Select T ME Press Valid again to confirm and move si vers 1 FFF Bad onto programming the intervals or y l1 r1 l1 s press Select to adjust the other digits HN C ng gl al then confirm by pressing Valid Select ww cm as On Valid gt Invalid date If a year is incompatible with the month and date previously selected the year and the date will be displayed alternately rapidly blinking Press Valid to reprogram t
23. let via a transformer and has 2 lights on its front panel BEN 12 Diasys Integra II Manual GB Revision 4 4 Description of the equipment 4 3 The cuff and the air electric double tubing for connection to the Diasys Integra Il The Diasys Integra II cuff offers features which have been specially designed for ambulatory recording cone shaped for better ergonomics stabilising flap for optimal positioning washable material Itis made up of a bladder a fabric cuff cover a double air electric tubing for connection to the Diasys These items can be changed separately if necessary Oo O Diasys Integra II Manual GB Revision 4 13 DIASYS Preparing Diasys Integra II for monitoring To prepare the unit follow the instructions below Charge the battery Insert the battery into the unit Program the unit Place the unit and cuff on the patient e Start up the unit and carry out the test measurements If any problem occurs please contact your local representative for assistance 5 Preparing for monitoring 5 1 Preparing the battery 5 1 1 The battery charger The Diasys charger is fast fully automatic and easy to use Red light low brightness power on normal brightness blinking discharging normal brightness fixed charging 9M E A Green light end of charge The front panel There is an indicator light LED on each
24. ly during this 10 second display and monitoring begins in the AUSCULTATORY mode if the Diasys Integra II was programmed for this by the DiasySoft or HolterSoft software AUSC will be displayed before each measurement the OSCILLOMETRIC mode if the Diasys Integra II was programmed for this by the DiasySoft or HolterSoft software OSCI will be displayed before each measurement the AUTOMATIC mode if neither of the above modes was specifically programmed AUTO will be displayed before the two test measurements and thereafter either AUSC or OSCI will be displayed before each measurement as appropriate If COMM is displayed this means the Diasys contains an un read recording The procedure must be read cf 7 1 before another recording can be started 6 2 Test measurements Atthe start of monitoring the Diasys Integra II automatically carries out 2 test measurements separated by a 2 minute interval with a minimum of 30 seconds between the end of the first and the beginning of the second in the AUSCULTATORY or OSCILLOMETRIC mode depending on which has been chosen In the AUTOMATIC mode these first two measurements are always carried out in the AUSCULTATORY mode unless a problem occurs The first test is made with a standard band pass The second is made after optimisation of the band pass according to the signal detected during the first measurement BEND Diasys Integra II Manual GB Revision 4 35 Cau
25. n anti perspirant if necessary We recommend you place a single use cuff protector on the inside of the cuff for hygiene reasons take the protections off the adhesive strips apply the adhesive strips on the inside of the cuff lining the cuff connector up to the edge of the pouch Fig 2 Fig 2 Positioning the cuff protector 24 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring Position the markings on the cuff arrow and ART opposite the artery and wind the cuff evenly around the arm Fig 3 Fig 3 Positioning the cuff Pass the tubing behind the patient s neck and connect first the microphone then the air tubing to the Diasys Fig 4 with the diasys already in its pouch Fig 4 Connecting the cuff to the Diasys Diasys shown without its pouch for better illustration Diasys Integra II Manual GB Revision 4 25 When the test measurements have confirmed that the microphone is working correctly click an adhesive patch ref D10 8073 onto the stabilising flap behind the air tubing and place it on the patient s arm to ensure that the cuff stays in place during the whole of the monitoring Fig 5 Fig 5 Clicking an adhesive pad onto the stabilising flap and placing it on the patient s arm This precaution is strongly recommended if the auscultatory mode has been chosen 5 4 2 Recommendations for positioning the cuff Cuff size It is esse
26. ntial to choose the appropriate size of cuff for the circumference of the patient s arm to avoid any discomfort or measurement errors The maximum arm circumference for the cuff is given by lining up the two vertical lines where MAX is printed Above this limit a larger cuff should be used The minimum arm circumference for the cuff is given by lining up the two vertical lines where MIN is printed on the cover 26 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring Correct Maximum Cuff too small Fig 6 Position of the cuff Arm circumference 18 24 cm Small 24 32 cm Standard 32 40 cm Large Table recommended cuff size for arm circumference Cuff shape The Diasys cuff is conical and thus perfectly adapted to the anatomy of the arm However to avoid any risk of discomfort for the patient positioning still requires particular attention The two areas of velcro must be lined up and opposing The cuff must be wound evenly amp 8 amp The cuff should be neither too loose this could increase the inflation time and result in a malfunction in which case the relevant error code would be displayed nor too tightly wound around the patient s arm uncomfortable Diasys Integra II Manual GB Revision 4 27 5 4 3 Changing arm The cuff has been designed so that it can if necessary be worn on the right arm This is done as follows Disconnect the air t
27. of the shape of the oscillometric curve of the cuff pressure of which the maximum point represents the mean pressure In this mode the patient must stay still during the measurement 3 3 Automatic mode This is the standard operating mode if no other mode has been specifically programmed In this mode the two test measurements made at the beginning of monitoring are carried out as follows the first measurement tests the quality of the K2 component of the Korotkoff sounds so that monitoring can be adapted accordingly the second measurement tests this component having adjusted the numerical filter If after this double test the K2 component is sufficiently consistent the Diasys Integra II will choose to function in the auscultatory mode If not the unit will opt for the oscillometric mode 8 Diasys Integra II Manual GB Revision 4 3 Functions a 3 4 BP Measurement accuracy Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultatory method within the limits prescribed by the American National Standard Manual Electronic or automated sphygmomanometers oo Diasys Integra II Manual GB Revision 4 9 DIASYS Description of the equipment Diasys and standard accessories Diasys Integra II recorder 2 rechargeable NiMH batteries cuff with double air electric tubing for connection to the Di
28. or Mode selector switched from measurement position to programming position Er 19 Impossible to process oscillometric shapes Er 26 Error during modem transmission cf chapter 7 2 Er 27 Connection to number called impossible during transmission cf chapter 7 2 40 Diasys Integra II Manual GB Revision 4 DIASY gt Reading the recordings 7 1 Transmission to a PC or a printer Connect the Diasys to a printer or a computer equipped with DiasySoft or HolterSoft software with the cable link This connection will automatically interrupt the ongoing recording and the unit will display COMM Communication This message is displayed during the whole time that the Diasys is connected If COMM is not displayed this probably means that the unit is in the safeguard mode in which case the battery should be changed If the problem continues check that the cable link is properly connected The report is printed as soon as the printer is ready If the battery is dead keys blocked and blank display or run down Er14 disconnect the cable and change the battery to resume printing Wait until 8888 is no longer displayed before connecting the Diasys Note that it is always possible to make a print out as long as a new recording has not been initiated Also a recording can be continued after data transmission to a PC press the pink key after disconnecting the Diasys This is not possible
29. ort XX vertical position horizontal position 5 4 5 1 The ECG cable integrated position sensor This sensor is positioned at the thorax and differentiates between a lying position and all other positions It can also be used to automatically change the measurement interval from daytime to night time and vice versa and trigger measurements should the position change 5 4 5 2 The orthostatism cable integrated position sensor This sensor is positioned on the thigh and differentiates between a standing position and all other positions It can also automatically trigger measurements should the position change To benefit from the features associated with the position sensors other than position identification the POSITION option of the DiasySoft or HolterSoft software must be installed Diasys Integra II Manual GB Revision 4 31 DIASYS INTEGRA Dr 08 07 95 1 31 1 12 Patient Paziente Paciente Blondin T 07 20 Age Alter Et Edad Idade 65 22h35 Sexe Sex Geschlecht Sesso Sexo M 64 80 80 Mesures Measurements Messungen Misurazioni Medidas a 2 sys pra X A v 18 34 A nc MK 102 70 81 32 80 18 40 osc IK 89 72 78 17 81 18 45 A nc MK 90 72 78 18 75 19 00 osc IK 104 72 83 32 72 19 15 A nc mo 108 70 83 38 71 19 30 osc Ix 109 69 82 36 75 19 45 A nc EK 112 94 100 18 75 20 00 osc IK 12
30. r any necessary repair will be sent by mail or by fax The repair can only be carried out upon reception of a customer order 6 8 Electrical safety standards The Diasys Integra II complies with standards of protection against type B electrical shocks works exclusively with an internal power source is not protected against water penetration is designed to work on an irregular basis can not be used in the presence of an inflammable anaesthetic and air mix oxygen or nitrous oxide should not be used if the casing is damaged broken or cracked to avoid any electrical contact Diasys Integra II Manual GB Revision 4 47 complies to the EN NF 60 601 1 electrical safety standards complies to the EN 60 601 1 2 electromagnetic compatibility standard in force However use in particular conditions could be disturbed by interference complies with the EN1041 standard in force PES complies to the 93 42 CEE Directive applicable to Medical Devices The Diasys Integra II recorder requires a high performance power supply NOVACOR has therefore developed a special NiMH battery Using any other batteries in the Diasys could seriously damage the unit NOVACOR recommends the exclusive use of its own batteries The batteries should be disposed of in specific containers The destruction of the unit must respect the rules in force for the elimination of waste NOVACOR will provide electrical circuit diagrams for
31. rements in the auscultatory mode have failed and the 5 corresponding palliative measurements have been carried out successfully then the unit will switch to the oscillometric mode and will stay in this mode for the rest of the monitoring period 6 5 Suspend mode If the measurement and the corresponding palliative measurement fail four times consecutively the Diasys Integra II goes into suspend mode Diasys Integra II Manual GB Revision 4 37 The measurements will be carried out according to the programmed cycle but without the palliative measurements Also the inflation level will be 150mmHg As soon as a valid measurement is recorded the unit comes out of suspend mode and the recording continues as programmed 6 6 Measurements which are not memorised By pressing the 2 keys simultaneously the physician can trigger at any time a measurement which will not be memorised measurements are displayed only without affecting the ongoing program Press Valid and Select simultaneously to trigger a measurement which will Stop Rec not be memorized On Select Valid 6 7 Display of measurements After each measurement the unit displays successively Standard function Measurement mode Hu 5L or use SYS mm Systolic pressure pa 493 H perl DN ai Diastolic pressure DIA mmHg Oy a Heart rate 98 Patient s position e if sensor is used As or pa QKd value 33m if ECG and Q
32. ry into its compartment do not try to force it in Check that the above instructions have been carefully followed before trying again Holding the battery in place in its compartment slot the battery cover back into its grooves and slide it back into place The battery must be replaced before each new clinical procedure Do not store the Diasys with a discharged battery in it Do not leave a recharged battery in the Diasys for more than a month without using it Diasys Integra II Manual GB Revision 4 19 5 2 2 Safeguard battery non rechargeable lithium The Diasys Integra II is equipped with a safeguard battery enabling programming settings and data in memory to be protected if the main battery fails or is missing thus providing the user with maximum security The safeguard battery has a lifetime of 3 to 5 years It is not accessible from the exterior of the unit Its status is systematically tested every time an NiMH battery is placed in the unit as follows when the battery is inserted the Diasys automatically tests the safeguard battery and displays one of the following messages for 3 seconds either indicating that the lithium battery is functioning correctly or indicating that the lithium battery is not functioning see chapter 8 Replacing the safeguard battery 5 3 Programming the Diasys Integra Il Mode selector in Programming position Only manual programming operations are
33. sm cable ACC 0100 00 Printer Diasys Printer cable ACC 0153 00 Diasys Modem cable ACC 0154 00 Diasysoft for PC parallel access key LOG 0100 00 Diasysoft for PC USB access key LOG 0100 10 Diasys PC cable ACC 0150 01 Diasys Integra Il manual on CD Rom Standard cuff including bladder ACC 0200 01 Large cuff including bladder ACC 0201 01 Small cuff including bladder ACC 0202 01 Air electric tubing standard with microphone ACC 0250 00 Air electric tubing large with microphone ACC 0251 00 Air electric tubing small with microphone ACC 0252 00 Standard bladder ACC 0300 00 Large bladder ACC 0301 00 Small bladder ACC 0302 00 Adhesive pads for stabilizing flap ACC 0600 00 Diasys Integra ll protective pouch ACC 0506 00 Standard cuff protectors 50 ACC 0450 00 M NOVACOR
34. tion In the AUTOMATIC mode the first two measurements are preceded by the display of AUTO even though they are made in the AUSCULTATORY mode unless a problem occurs If during the first measurement the microphone is not detected not connected electrical failure of the cable etc the unit will display Er 13 and carry out the second measurement in the OSCILLOMETRIC mode After these 2 measurements the unit will choose to function in priority in the auscultatory mode However if one of the following conditions occurs during these 2 measurements it will opt for the oscillometric mode Systol 50 mmHg Diastol 30 mmHg Measurement time 2 mn Time between 2 decrements 16 s Inflation pressure 295 mmHg In any case the Diasys will always display its elected mode until the first programmed measurement ause B5 1 enabling the physician to give the appropriate recommendations to his patient Mode Recommended patient behaviour at time of measurement AUSCULTATORY ECG gating Continue normal activity AUSCULTATORY without gating Activity should be restricted OSCILLOMETRIC Stay absolutely still At the start of monitoring the inflation level is 180 mmHg in the auscultatory mode and 220 mmHg in the oscillometric mode The following inflation levels are situated at about 20 mmHg above the previous systole in the auscultatory mode and 40 mm Hg in the oscillometric mode The two test measurem
35. tomer s responsibility If the unit is examined outside the guarantee period there will be at least a charge for administrative and testing costs 84 Calibration test The Diasys has a special function enabling the user to check that it is properly calibrated Put the mode selector in the Programming position i v Press the On Valid to display time Stop Rec E O 42 4C i l e l l On Select Valid Press both keys simultaneously A The unit displays TEST oP O LOC LL IL Select ons ld then Zero after about 5 seconds Stop Rec 0 JO Select a t Connect the Diasys a mercury column and an inflation bulb together using a Y shaped tube see overleaf Check that the two measurements match each other Press one of the keys or switch the mode selector to the Measurement position to end the test phase Diasys Integra II Manual GB Revision 4 45 Calibration test Ss When the test is finished the unit s functions are inhibited for 10 seconds Any attempt to use them during this period will result in a beep sound If the fault Auto calibration impossible Er 02 occurs during the calibration test the operation will have to be started again However if pressure goes above the maximum limit Cuff pressure gt 295 mmHg Er 09 the test will not be effected Sy We recommend carrying out the calibration test at least onc
36. ubing from the Diasys Open the cuff cover and the velcro remove the bladder and the tube Turn the bladder over Put the bladder back in the cuff making sure it is flat with the tube coming out opposite the stabilising flap Close the cuff Changing the bladder over The active side of the microphone without the sticker must always be against the arm 5 4 4 Setting up the ECG system The ECG gating system which can only be used in the auscultatory mode requires the use of an optional single channel ECG cable namely the ECG Cable with position sensor which is placed on the patient s chest in the CMS position using 3 solid gel electrodes Click the three gel electrodes onto the snap fasteners on the cable 28 Diasys Integra II Manual GB Revision 4 5 Preparing for monitoring Place the electrodes as in figure 3 Fig 3 Placing the ECG cable Diasys Integra II Insert the connector fully the red arrow face up Diasys Integra II Manual GB Revision 4 29 To disconnect the cable Remove the fixing head by pushing on the sides Then take out the cable by pressing on the top of the connector This system gates the Korotkoff sounds which occur after each QRS complex thus filtering artefacts more efficiently and significantly reducing measurement time Sy As ECG gating is based on detection of QRS complexes it is not suitable for patients with
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