Diasys Integra Access English
Contents
1. 20 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt 5 3 2 Programming the date Press Select to choose the date format Stop e ec dd mm or mm dd Q i O asi LIL cipet On Valid Press Valid to confirm The first digit will flash Stop Rec y erent TS On Valid Press Select to obtain the correct digit P D Stop_ vam e OD s Select TT si OnWalid Press Valid to confirm The second Rec a digit will flash Stop hare 7 DU tc 0 D LU GIC Select a On Valid Adjust the other digits as above Press 1 Stop Le Rec Valid to confirm Vem om O tHg Select ZUTE On Valid When the last digit has been oe NN PUS Rec confirmed all four digits will flash Press Valid to confirm the date The year will be diplayed Select ss a Press Select to adjust the last digit of P ree ee the year and press valid to confirm O Ta merc O 4 n O Select TA On Valid Press Valid again and the interval Stop programming will appear or press CS m m Z P y Select year 2000 onwards i am Select s l W2 On Valid Invalid date If a year is incompatible with the month and date previously selected the year and the date will flash alternately Press For the year 2000 onwards adjust the digits one by one as above and press Stop_ Valid to confirm The interval program2. Should not be used if the casing is damaged broken or cracked to avoid any electrical contact e Complies with the EN 1041 standard in force The Diasys Integra Access 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 customers if required Warning Only devices complying with IEC 950 standards can be connected 40 Diasys Integra Access Manual GB REV04 12 2010 8 Annexe Diasys Integra Access is meant to be used in an electromagnetic environment only as specified below The clinician should make sure the device is used in such an environment Fran ais Electromagnetic transmissions Transmission trials Conformity Warnings regarding the electromagnetic environment RF CISPR 11 transmissions Group 1 DIASYS uses RF energy for internal use only As a consequence RF transmissions are very weak and are not likely to cause any interference with a nearby electronic device RF CISPR 11 transmissions B Class DIASYS can be used in all institutions including in domestic buildings Harmonics transmission N A
3. CEI 61000 3 2 Tension fluctuation transmission CEI 61000 3 3 Electromagnetic immunity Immunity trials Trial levels Conformity Warning regarding the electromagnetic CEI 60601 environment Electrostatic 6kV in contact Congruent It is appropriate that shock 8kV in air That floors be made with wood concrete or tiles If floors are covered with synthetic materials relative humidity should be of at least 30 Immunity trials Trial levels Conformity Warning regarding the electromagnetic CEI 60601 environment Magnetic field at 3 A m Congruent Magnetic field at electric network s frequency electric network s should be at levels that characterize frequency a representative place located in a typical 50 60 Hertz hospital environment CEI 61000 4 8 RF conduct 3 Veff 3V Portable and RF mobile communication devices should not be located too close to any CEI 61000 4 6 From 150 kHz part of DIASYS including cables the to 80 MHz recommended separation distance should be outside the respected computed from the equation ISM brackets applicable to the transmitter frequency Recommended separation distance d 1 16 Vp d recommended separation distance in m p maximum power of transmitter output in W Ex See the following table Interferences can occur near devices marqued with the following symbol p Diasys Integra Access Manual GB REV04 12 2010 41 RF radiated 3 V
4. LL NOvVACOR Diasys Integra Access English NOVACOR SA 4 passage Saint Antoine 92508 Rueil Malmaison cedex France Manual Diasys Integra Access 1999 NOVACOR SA CE All rights reserved Introduction 4 2 Guarantee 5 2 1 Specific Guarantees concerning units 5 2 2 Accessories 5 2 3 Restrictions of the Guarantee 5 2 4 Responsibilities 5 2 5 User Information 6 2 6 Rights 6 3 How the Diasys Integra Access Functions 7 4 Description of the equipment 8 Diasys Integra Access and Standard Accessories 8 Optional accessories 8 4 1 The Diasys Integra Access recorder 9 4 2 The battery charger 10 4 3 The cuff and the connecting tube to the Diasys Integra Access Il 5 Preparing the Diasys Integra Access for monitoring 12 5 1 Preparing the battery 13 5 1 1 The battery charger 13 5 1 2 The battery 15 5 1 3 Charging the battery 15 5 1 4 End of charge 16 5 2 Inserting the battery into the recorder 17 5 2 1 Insertion 17 5 2 2 Safeguard battery non rechargeable lithium 18 5 3 Programming the Diasys Integra Access 18 5 3 1 Programming the time 20 5 3 2 Programming the date 21 5 3 3 Programming the intervals 22 5 4 Placing the unit on the patient 23 5 4 1 Positioning 23 5 4 2 Recommendations for placing the cuff 25 5 4 3 Changing arms 26 5 4 4 Positioning the Diasys Integra Access with the integrated position sensor optional 27 2 Diasys Integra Access Manual GB REV04 12 2010 Su
5. m of 80MHz 3 V m Recommended separation distance CEI 61000 4 3 at 2 5GHz D 1 16 Vp from 80MHZ to 800 Mhz d 2 3 Vp of 800Mhz at 2 5Ghz d Recommended separation distance in m p maximum power of transmitter output in W Field intensity of RF transmitters should be set determined by an electromagnetic investigation on location and should be lower than the level of conformity in each frequency range Ex See the following table Note 1 At SOMHz and at 800 MHz the highest frequency range applies Note 2 These guides cannot apply in all situations The electromagnetic spread is affected by the absoption and by the reflexions of structures objects and people a Field intensities of the transmitters that are set such as base stations for radiotelephones cellular wireless and land mobile radios amateur radio radio broadcasting AM and FM and TV broadcasting cannot be theoretically forecasted with accuracy In order to evaluate the electromagnetic environment due to set RF transmitters an electromagnetic investigation on location must be considered If the field intensity measured at the location where the DIASYS including the cables is used exceeds the level of RF conformity applicable above the DIASYS must be observed including the cables to check if it is running normally If abnormal performances are observed extra measures may be necessary in order to reorient or reposition the DIASYS inc
6. previous start up battery should be charged Press the pink key briefly during this 10 second display and monitoring will be initiated in the oscillometric mode 6 2 Test measurements M DS P Mode selector in measurement position At the start of the monitoring the Diasys Integra Access automatically carries out two test measurements in oscillometric mode separated by a two minute interval with a minimum of 30 seconds between the end of the first and the beginning of the second These measurements allow the Diasys to adapt the monitoring parameters 28 Diasys Integra Access Manual GB REV04 12 2010 6 How the units functions lt At the start of the monitoring the inflation level is 220mmHg the following levels being situated at about 40mmHg above the previous systole 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 e The two test measurements are never included in the statistical analysis They are however printed on the report and identified as being test measurements e If there is no specific programming the standard deflation steps 6 3 Manually activated measurements The pink key On enables manual measurements to be triggered whenever required Measurements activated manually are carried out in the unit s operating mo
7. units under guarantee Ifthe unit is examined outside the guarantee period there will be a minimum charge for the administrative and testing costs Upon receipt of the unit after the diagnostic tests a quote will be sent by mail or by fax No intervention can be carried out without an order from the client 36 Diasys Integra Access Manual GB REV04 12 2010 8 Maintenance 8 4 Calibration test The user can check that the Diasys is properly calibrated Put the mode selector in the Programming position M P Press the On Valid to display Time Stop Rec g test e Select TR On Valid Press both keys simultaneously Rec ll The unit displays TEST irre Select On Valid then Zero after about 5 seconds Stop Reg L Q Select On Valid e Connect the Diasys a mercury column and an inflation bulb together using a Y shaped tube see below Check that the two measurements match e Press one of the keys or switch the mode selector to the Measurement position to end the test phase Calibration test Diasys Integra Access Manual GB REV04 12 2010 37 When the test is finished the unit will not function for ten seconds Any attempt to use the functions will result in a beep If the fault Auto calibration impossible Er 02 occurs during the calibration test restart the operation However if the pressure exce
8. ack in the cuff making sure it is flat with the tube coming out opposite the stabilising flap Close the cuff 26 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt Fig 7 Changing the bladder over Do not forget to reposition the tube under the stabilising flap when going back to using the left arm 5 4 4 Positioning the Diasys Integra Access with integrated osition sensor optional Standing position patient sitting or standing up the unit must be vertical it should be positioned as normal on the belt fig 1 Lying position patient laying down the unit must be horizontal The patient can therefore keep it attached to the belt if lying down He can also take the belt off but must keep the unit down flat fig 8 Fig 8 Recommended Diasys position when patient lying down Diasys Integra Access Manual GB REV04 12 2010 27 6 How the unit functions 6 1 Start up M DS 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 indicated by COMM or MOD on the display To start up the unit keep the pink key pressed down and release it after the fourth beep One of the following messages will be displayed for 10 seconds Battery replaced since previous start up Battery not replaced since
9. alid 6 7 Display of measurements After each measurement the unit displays successively Standard function TT Measurement mode Z SYS mmHg 1 Systolic pressure Diastolyc pressure DIA mmhe co wt Heart rate 2 wc ict 30 Diasys Integra Access Manual GB REV04 12 2010 6 How the units functions lt Options Diasys Integra Access with position sensor option Patient s position or ER 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 Stop Rec press the green key briefly Error 17 f will be displayed see the display table overleaf Select On Valid Monitoring can be stopped at any time Stop Rec by holding the green key down you will hear a series of beeps STOP will Q be displayed Select On Valid 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 Diasys Integra Access Manual GB REV04 12 2010 31 6 9 Display codes As well as the display of the functioning mode any problems occuring during a measurement are indicated by the display of an error code see below which is also noted as such on the printed report if the software is not used If the DiasySoft software is used these problems w
10. atteries ready to use Battery slot The Diasys Integra Access 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 outlet via a transformer and has two lights on the front panel 10 Diasys Integra Access Manual GB REV04 12 2010 4 Description of the equipment 4 3 The cuff and the connection tube to the Diasys Integra Access The Diasys Integra Access cuff offers features specially designed for ambulatory recording e Cone shaped for better ergonomics e Stabilising flap for optimal positioning to be used with adhesive pads e Easy handling e Washable material by D Diasys Integra Access Manual GB REV04 12 2010 11 5 Preparing the Diasys Integra Access for monitoring To prepare the unit follow the instructions below e Charge the battery e Insert the battery e Program the unit e Place the unit on the patient e Start up the unit and carry out the test measurements 12 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt 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 normal brightness blinking discharg
11. back on the modem reconnect the Diasys to the modem to trigger a new transmission 34 Diasys Integra Access Manual GB REV04 12 2010 7 Reading the recordings lt 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 Diasys Integra Access Manual GB REV04 12 2010 35 8 Maintenance 8 1 Handling the equipment Do not use your nails or a sharp object when pressing the programming keys The design of the Diasys Integra Access 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 Clean the Diasys Integra Access regularly with a soft cloth lightly moistened with alcohol or a cleaning product not containing solvents or detergents Avoid all contact with liquids For hygiene clean the cuff cover in soapy water after each patient by hand or in a washing machine on delicate cycle 30 40 8 3 Maintenance Maintenance is carried out in our workshop as rapidly as possible We are unable however to provide a loan unit during the repair period or to provide compensation of any kind Transport costs are the customer s liability including
12. cess Manual GB REV04 12 2010 5 Preparing for monitoring lt 5 1 2 The battery The Diasys Integra Access is delivered with two rechargeable Nickel Metal Hydride NiMH batteries These batteries have been specially developed for the Diasys series and can be recharged about 300 times if used according to the recommendations in this manual Precautions to be taken with the batteries e Take care not to invert the polarities Do not store at over 45 C e Do not exceed the recommended recharge time otherwise the unit risks stopping during a recording 5 1 3 Charging the Battery e 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 low brightness e Place the battery in the charger taking care to match the and signs with those on the charger e Insert the battery into its slot Ooo O Diasys Integra Access Manual GB REV04 12 2010 15 e When the battery is placed in the charger the red light will become brighter and will be either fixed immediate charge flashing discharge before recharge Duration of charge cycle Without prior discharge about a maximum of 1 hour With prior discharge discharge up to 1 hrs plus charge about 1 hr Do not use a different non Novacor charger to recharge Diasys Integra Access bat
13. cting the Diasys This is not possible after direct transmission to a printer Connecting the Diasys to a printer or a computer requires different cable links Ask your distributor for details oo Diasys Integra Access Manual GB REV04 12 2010 33 7 2 Modem Transmission optional This option 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 an M series Diasys integra Access M for Modem Transmission 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 number to be called reception modem entered in the DiasySoft communication window version V4 5 or a above during programming the reception computer must be on and the NovaModem tele reception module open and waiting reception The modem must be plugged into the mains and the telephone socket and switched on 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 or Er27 or COMM are displayed disconnect the Diasys from the modem turn off and switch
14. de The next pre programmed measurement will be cancelled if it is due to occur in less than two minutes 6 4 Palliative measurements If a measurement is defective a palliative measurement will be triggered two 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 two pre programmed measurements is less than five minutes Manual and palliative measurements do not disrupt the sequence of the pre programmed measurement intervals oo Diasys Integra Access Manual GB REV04 12 2010 29 6 5 Suspend mode If the measurement and the corresponding palliative measurement fail four times consecutively the Diasys Integra Access goes into suspend mode 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 initially programmed 6 6 Measurements which are not memorised By pressing the two 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 Stores Reo not be memorised Q Select On V
15. e selector switched from measurement position to programming position Er 19 Impossible to process oscillometric shapes Er 25 Heart rate unstable during measurement Er 26 Error during modem transmission cf chapter 7 2 Er 27 Connection to number called impossible during transmission cf chapter 7 2 32 Diasys Integra Access Manual GB REV04 12 2010 7 Reading the recordings lt 7 Reading the recordings 7 1 Transmission to a PC or a printer Connect the Diasys to a printer or a computer equipped with DiasySoft 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 Er 14 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 disconne
16. eds the maximum limit Excessive cuff pressure Er 09 the test will not be affected We recommend carrying out the calibration test at least once a year in order to avoid any loss in performance 8 5 Replacing the safeguard batter The lithium safeguard battery is indispensable to the correct functioning of the Diasys Integra Access 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 tell you where to send the unit 8 6 Storage and dispatching Remove the battery if the Diasys is to be stored for more than a few days The Diasys Integra Access 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 38 Diasys Integra Access Manual GB REV04 12 2010 gt s Ne vis Qa 8 Maintenance 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 T
17. egrated position sensor enabling the unit to detect whether the patient is vertical awake or horizontal resting Ooo O Diasys Integra Access Manual GB REV04 12 2010 7 4 Description of the equipment Diasys Integra Access and standard accessories e Diasys Integra Access recorder e Two rechargeable NiMH batteries same as Diasys Integra batteries Standard adult sized cuff e Protective pouch and belt Optional accessories e Battery charger e DiasySoft software customised according to the programming options required and the user s language and access key Printer e Diasys Printer or Diasys Computer linking cabl e e Diasys Modem linking cable 8 Diasys Integra Access Manual GB REV04 12 2010 4 Description of the equipment lt 4 1 The Diasys Integra Access recorder Mode selector M measurement P program P mode display switched on On and validation of options Valid M mode monitoring started On and activation of a manual recording Rec Air connector On Valid DIASYS INT Ee Ra Aes s RS232 connector for printer or modem P mode next choice Select M mode stop measurements Stop Ooo O Diasys Integra Access Manual GB REV04 12 2010 9 Battery cover 4 2 The battery charger 12 v direct current Red light power low brightness charging normal brightness discharge blinking Green light end of charge b
18. ement precision 3 mmHg deflation levels 8 12 mmHg Signal input output type type RS 232 measurement ranges systole 295 50 mmHg diastole 180 30 mmHg mean 295 30 mmHg heart rate 240 40 min Complies to the EIA 232 E standard 8 12 Accessories Accessory Reference Diasys Integra Access D11 8125 Battery D10 1000 Charger D10 8122 Printer According to model Diasys Printer Cable D10 4000 DiasySoft for PC D10 7000 PC DiasySoft for Mac D10 7000 Mac Diasys PC cable D10 5000 00 Diasys Mac cable D10 5000 01 PC access key D10 7400 Mac access key RTE 8120 01 Diasys Integra Access Manual D11 7100 Diasysoft manual D10 7200 Diasys Integra Access DiasySoft quick reference guide D11 7200 Standard adult cuff bladder included D11 3000 00 Standard large adult cuff bladder included D11 3002 00 Adhesive pads for stabilising flap D10 8073 Diasys Integra Access protective pouch D11 8126 Adult cuff protectors 50 D10 3000 06 44 Diasys Integra Access Manual GB REV04 12 2010
19. g 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 4 Diasys Integra Access Manual GB REV04 12 2010 2 Guarantee lt 2 Guarantee NOVACOR undertakes to deliver merchandise conforming to the technical specifications mentioned and to replace any merchandise recognised as being defective 2 1 Specific guarantees concerning units Each unit is identifiable by a specific serial number NOVACOR guarantees the unit Diasys Integra Access and charger for one year from the date of delivery against any defect resulting in abnormal functioning of the unit 2 2 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 outside our workshop 2 units damaged by negligence by accident or if the user instructions have not been followed correctly If necessary contact your distributor or our after sales service We do not accept units 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
20. he invoicing covers the tests only the quote for any necessary repair will be sent by mail or by fax The repair can only be carried out upon reception of a customer order 8 8 Norms and safety standards Diasys Integra Access work exclusively with an internal power source and comply with class BF device protection standards This sign on a device indicates to the user that complementary information is to be consulted in the accompanying documents Diasys Integra Access complies to the EN 60 601 1 2 electromagnetic compatibility standard However use under certain specific conditions may be effected by disturbances CE mark conform to the 93 42 CEE European Directive applied to medical devices The product should be disposed in an appropriate recovery and recycling structure The device does not possess any specific protection against humidity as a consequence it is recommended to store it in a dry place Storage Temperature Limits Keep away from sunlight Humidity Storage Limits Pressure Storage Limits Ooo O Diasys Integra Access Manual GB REV04 12 2010 39 The Diasys Integra Access e Complies with standards of protection against low frequency electrical shocks e Works exclusively with an internal power source e Is not protected against water penetration e Is designed to work on an irregular basis e Can not be used in the presence of an inflammable anaesthetic and air mix oxygen or nitrous oxide
21. ill be detailed both on the computer screen and on the report Display Meaning Comment OSCI Oscillometric mode COMM Communication established with printer or computer MOD Communication established with modem GOOD Modem transmission successful TEST Calibration test STOP Manual stopping of monitoring Stop key held down 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 50mm not confirmed Er 05 Abnormal pressure variation Muscular contraction or excessive exercise Er 07 Excessive measurement time Measurement time gt 120 s Er 09 Excessive cuff pressure Er 10 Excessive noise or artefacts Interference on signal measurement impossible Er 11 Systolic pressure lt 50mmHg Er 12 Diastolic pressure lt 30mmHg Er 14 Battery run down Er 15 Not used 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 selector Mod
22. ing CHARGER Green light end of charge The front panel There is an indicator light LED on each 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 e That the battery is being charged fixed light normal brightness ee Diasys Integra Access Manual GB REV04 12 2010 13 The green light indicates that the operation is finished and the battery is charged The back panel base A selector 2 red switches determines the charge mode to ensure a long life of the batteries 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 e Whichever mode is chosen the green light comes on when the battery is charged indicating that it is ready to be used e The position of switch 2 should never be changed and should always remain in the position shown above e Never use the charger with any batteries other than those supplied by NOVACOR External power sources must comply with EN 60 601 standards 14 Diasys Integra Ac
23. lly with a stethoscope about 2cm above the crease of the elbow e Clean the inside of the arm and apply an antiperspirant 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 Diasys Integra Access Manual GB REV04 12 2010 23 Fig 2 Positioning the cuff protector e 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 e Pass the tubing behind the patient s neck and connect the cuff connector to the Diasys preferably already in the protective pouch fig 4 Fig 4 Connection of the cuff to the Diasys Diasys is shown without pouch for better illustration 24 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt e Once the test measurements have confirmed that the Diasys is working properly click an adhesive patch 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 patch onto the stabilising flap and placing it on the patient s arm 5 4 2 Recommendations for positioning the cuff Cuff size It is essen
24. luding the cables on the range of frequencies 150kHz to 80MHz field intensities must be lower than 3 V m Recommended separation distances between portable devices and RF communication mobiles and the DIASYS The DIASYS is meant to be used in an electromagnetic environment in which RF disturbances are checked The DIASYS user can help prevent electromagnetic disturbances by maintaining a minimum distance between the portable device and the RF communication mobile transmitters and the DIASYS as it is recommended below according to the maximum transmission power of the communication device Maximum Separation distance in accordance with the tranmitter frequency m transmission From 150 kHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2 5 GHz power assigned d 3 5 3 Vp d 3 5 3 Vp d 7 3 Vp to the transmitter W 0 01 0 1 0 1 0 2 0 1 0 3 0 3 0 7 1 1 1 1 1 2 3 10 3 6 3 6 7 3 100 11 6 11 6 23 3 For transmitters for which the maximum transmission power assigne dis not displayed above the recommended separation distance d in meters m can be estimated bu using the equation applicable to the frequency of the tranmitter where P is the maximum power of output of the transmitter in watts W according to the manufacturer of that transmitter Note 1 At 80 MHz and at 800 MHz The separation distance for the highest frequency range applies Note 2 These guides may n
25. ming will appear Select is e valid to reprogram the date and the year or press e select to reprogram just the year Diasys Integra Access Manual GB REV04 12 2010 21 5 3 3 Programming the intervals The daytime sun and night time k i Stop moon images are displayed alternately next to the corresponding intervals Select Press Select and the daytime interval will flash Press Select to adjust the daytime interval Press Valid to confirm the daytime interval The night time interval will flash Press Select to adjust the night time interval Press Valid and the new intervals will flash alternately Press Valid to end the programming The time screen will be displayed On Valid The following intervals are available Intervals in minutes 1 ry O Daytime 2 3 4 5 6 10 15 20 30 45 60 Night time 10 15 20 30 45 60 When the selector is in the Programming mode press the pink key to scan the unit s program Time Date Year measurement Intervals 22 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt 5 4 _ Placing the cuff on the patient 5 4 1 Positioning Fig 1 patient with Diasys and cuff No particular precautions are necessary for positioning the cuff for the oscillometric mode however we recommend you follow these indications e Locate the path of the humeral artery idea
26. mmary lt 6 How the unit functions 28 6 1 Start up 28 6 2 Test measurements 28 6 3 Manually activated measurements 29 6 4 Palliative measurements 29 6 5 Suspend mode 30 6 6 Measurements which are not memorised 30 6 7 Display of measurements 30 6 8 Stopping measurements 31 6 9 Display codes 32 7 Reading the recordings 33 7 1 Transfer to a PC or a printer 33 7 2 Modem Data Transmission optional 34 8 Maintenance 36 8 1 Handling the equipment 36 8 2 Cleaning the equipment 36 8 3 Maintenance 36 8 4 Calibration test 37 8 5 Replacing the safeguard battery 38 8 6 Storing and dispatching 38 8 7 Preventative maintenance 39 8 8 Norms and safety standards 39 8 9 Precautions of use 43 8 10 Physical specifications 43 8 11 Technical specifications 44 8 12 Accessories 44 Diasys Integra Access Manual GB REV04 12 2010 3 1 Introduction The Diasys Integra Access is a non invasive ambulatory system for measuring and recording blood pressure in oscillometric mode It measures the systole the diastole mean blood pressure and the heart rate for up to 48 hours The Diasys Integra Access unit weighs about 200g 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 Access can be printed out directly in report form by a printer connected to the unit If a computer is used recordin
27. or from failure to follow the instructions in the user manual Although NOVACOR manufactures products to the highest standards it cannot be held responsible for the validity or the accuracy of the measurements made by its units Diasys Integra Access Manual GB REV04 12 2010 5 2 5 User information 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 and developments to the Diasys Integra Access as they become available 2 6 Copyrights Diasys Integra Access Manual 1999 Novacor S A All rights reserved Diasys Integra Access DiasySoft and their respective logos are registered trademarks of NOVACOR S A Macintosh is a registered trademark of Apple Computer International MS DOS and Windows are registered trademarks of Microsoft Corporation 6 Diasys Integra Access Manual GB REV04 12 2010 3 How the Diasys Integra Access functions 3 How the Diasys Integra Access functions The Diasys Integra Access is a non invasive automatic ambulatory blood pressure recorder operating in oscillometric mode The oscillometric measurement is based on analysis of the shape of the oscillometric curve of the cuff pressure of which the maximum point represents the mean pressure The patient s arm must stay still during measurement The Diasys Integra Access also has an optional int
28. ot be applied in every situation The electromagnetic spread is affected by the absorption and by the reflexion of structures objects and people Ces guides peuvent ne pas s appliquer dans toutes les situations 42 Diasys Integra Access Manual GB REV04 12 2010 8 9 Precautions of use e Certain particular physiological characteristics of a patient ausculatory gapss arrhythmia could influence the reliability of the measurement We recommend checking the unit is working correctly by comparing a measurement with that of a stethoscope before beginning the monitoring 8 Annexe Fran ais e This equipment must be used by qualified medical personnel trained in its use The patient should be informed about possible malfunctions of the unit excessive or frequent inflations permanent pressure in the cuff and of the possibility to stop a measurement or the recording himself at any time 8 10 Physical specifications Length 93 mm 88 mm Width 63 mm 88 mm Height 27 mm 34 mm Weight with batteries 195g 130 g Storage temperature 40C 70C 40 C 70C Functioning temperature 0C 50C 0C 50C Ooo O Diasys Integra Access Manual GB REV04 12 2010 43 8 11 Technical specifications recorder type pressure holter measurement mode oscillometric recording length up to 48 hrs maximum measurements 200 measur
29. teries Go through the charge cycle 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 2 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 up to one week 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 e 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 for a long period of time 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 a measurement 16 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt 5 2 Inserting the batteries into the recorder 5 2 1 Insertion Slide off the battery cover 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 Slide off the battery cover The arrow on the battery should be pointing towards the bottom of the compartment as shown below If it is difficult to insert
30. the battery do not force it Check that the above instructions have been carefully followed before trying again Holding the battery in place slot the battery cover back into the grooves and slide it into place 5 The battery must be replaced before each new clinical procedure Do not store the Diasys with a discharged battery inside Do not leave a recharged battery in the Diasys for more than 2 weeks without using it Diasys Integra Access Manual GB REV04 12 2010 17 5 2 2 Safeguard battery non rechargeable lithium The Diasys Integra Access has a safeguard battery enabling program 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 will normally last for 3 to 5 years It is not accessible to the user Its status is systematically tested every time an NiMH battery is placed in the unit as follows When the battery is inserted the Diasys Integra Access automatically tests the safeguard battery and displays one of the following messages for 3 seconds either indicating that the lithium battery is functioning properly EEE indicating that the lithium battery is not functioning see chapter 8 replacing the safeguard battery 5 3 Programming the Diasys integra Access J sak mode selector in Programming position This manual only concerns manual programming Software programming is full
31. tial 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 MAXI is printed Above this limit a larger cuff should be used s m n Correct Maximum Cuff too small Fig 6 Position of the cuff Diasys Integra Access Manual GB REV04 12 2010 25 Arm circumference Cuff 18 24cm Paediatric 24 32 cm Adult 32 40 cm Large Table recommended cuff size for arm circumference Cuff shape The Diasys Integra Access 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 a a 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 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 tubing from the Diasys Open the cuff cover and remove the bladder passing the tube under the stabilising flap Turn the bladder over Put the bladder b
32. y explained in the DiasySoft manual We recommend that a recharged battery be inserted each time before programming If the battery is run down the Diasys Integra Access will display the message ER 14 if it is dead the unit s keys will be blocked safeguard mode 18 Diasys Integra Access Manual GB REV04 12 2010 5 Preparing for monitoring lt During programming if the selector or the two programming keys are not used for a certain time the screen will switch off to save battery power Press one of the keys to retrieve the time screen Diasys Integra Access Manual GB REV04 12 2010 19 5 3 1 Programming the time Press Valid to display the time Stop Rec i Select On Valid Press Select and the first digit will flash 6 Select Press Select to obtain the correct digit Stop d Select Press Valid to confirm The second R digit will flash Select Adjust the second digit and press valid Stop to confirm Select The AM PM setting will flash Press Stop Valid to make AM flash If PM is required press Select then Valid Select Adjust the two minute digits as above Si op Select When the last digit has been validated i Rec all four digits will flash Press Valid to confirm the time The date will be displayed Select On Valid Note that the AM PM setting is only proposed if the time is programmed before midday
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