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Diasys Integra II Manual
English
NOVACOR SA.
4, passage Saint-Antoine
92508 Rueil-Malmaison Cedex - France
Diasys Integra II Manual ©2005 NOVACOR SA. - All rights reserved.

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  • Page 1 Diasys Integra II Manual English NOVACOR SA. 4, passage Saint-Antoine 92508 Rueil-Malmaison Cedex - France Diasys Integra II Manual ©2005 NOVACOR SA. - All rights reserved.
  • Page 2: Table Of Contents

    Main optional accessories 4.1. The Diasys Integra II recorder 4.2. The battery charger 4.3. The cuff and the air/electric double tubing for connection to the Diasys Integra II 5. Preparing Diasys Integra II for monitoring 5.1. Preparing the battery 5.1.1. The battery charger 5.1.2.
  • Page 3 8.4. Calibration test 8.5. Replacing the safeguard battery 8.6. Storage and dispatching 8.7. Preventative maintenance 8.8. Electrical safety standards 8.9. Others precautions of use 8.10. Physical specifications 8.11. Technical specifications • Diasys Integra II Manual - GB - Revision 4...
  • Page 4: Introduction

    (QKd). 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.
  • Page 5: Guarantee

    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.
  • Page 6: 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.
  • Page 7: How The Diasys Integra Ii Functions

    How the Diasys Integra II 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.
  • Page 8: Auscultatory Mode

    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).
  • Page 9: 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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 10: Description Of The Equipment

    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 Diasys, • protective pouch and belt. Main optional accessories • battery charger, •...
  • Page 11: The Diasys Integra Ii Recorder

    Air connector On/Valid Stop Select ECG cable and position sensor connection RS232 connector for printer, ordinateur or modem P mode: next choice (Select) Battery cover M mode: stop measurements (Stop) • Diasys Integra II Manual - GB - Revision 4...
  • Page 12: The Battery Charger

    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 2 lights on its front panel. • Diasys Integra II Manual - GB - Revision 4...
  • Page 13: The Cuff And The Air/Electric Double Tubing For Connection To The Diasys Integra

    4 . D e s c r i p t i o n o f t h e e q u i p m e n t 4.3. The cuff and the air/electric double tubing for connection to the Diasys Integra II The Diasys Integra II cuff offers features which have been specially designed for ambulatory recording: • cone-shaped for better ergonomics, •...
  • Page 14: Preparing Diasys Integra Ii For Monitoring

    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 • Start up the unit and carry out the test...
  • Page 15: Preparing The Battery

    - 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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 16 • 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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 17: The Battery

    5 . P r e p a r i n g f o r m o n i t o r i n g 5.1.2. The battery The Diasys Integra II is delivered with two rechargeable Nickel-Metal Hydride (NiMH) batteries (ref. D10-1000).
  • Page 18: End Of Charge

    • 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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 19: Inserting The Battery Into The Recorder

    • 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...
  • Page 20: Safeguard Battery (Non-Rechargeable Lithium)

    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.
  • Page 21: Programming The Time

    Press Valid to confirm the time. The date will be displayed. Select Valid Note that the AM/PM setting is only proposed if the time is programmed before midday. • Diasys Integra II Manual - GB - Revision 4...
  • Page 22: Programming The Date

    • Press Valid to reprogram the date and the year. • Or press Select to reprogram just the year. • Diasys Integra II Manual - GB - Revision 4...
  • Page 23: Programming Intervals

    10 - 15 - 20 - 30 - 45 - 60 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...
  • Page 24: Placing The Cuff On The Patient

    - 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 • Diasys Integra II Manual - GB - Revision 4...
  • Page 25 Diasys (Fig. 4), with the diasys already in its pouch. Stop Stop Select Select Fig 4 - Connecting the cuff to the Diasys Diasys shown without its pouch for better illustration • Diasys Integra II Manual - GB - Revision 4...
  • Page 26: Recommandations For Positionning The Cuff

    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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 27 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...
  • Page 28: Changing Arm

    CM5 position using 3 solid gel electrodes: - Click the three gel electrodes onto the snap fasteners on the cable. • Diasys Integra II Manual - GB - Revision 4...
  • Page 29 Fig 3 Placing the ECG cable Position sensor On/Valid Stop Select Diasys Integra II - Insert the connector fully (the red arrow face up). - Then click on the fixing head. • Diasys Integra II Manual - GB - Revision 4...
  • Page 30: Index Of Arterial Distensibility (Qkd)

    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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 31: Position Sensor

    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...
  • Page 32 19:45 A.nc 20:00 20:15 A.nc 20:30 20:45 A.nc 21:00 21:15 A.nc Conclusions / Conclusions / Schlußfolgerungen / Conclusioni / Conclusiones / Conclusões Example of a report using the position sensor. • Diasys Integra II Manual - GB - Revision 4...
  • Page 33 5 . P r e p a r i n g f o r m o n i t o r i n g • Diasys Integra II Manual - GB - Revision 4...
  • Page 34: How The Unit Functions

    How the unit functions 6.1. Start up (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”...
  • Page 35: Test Measurements

    6 . H o w t h e u n i t f u n c t i o n s Press the pink key briefly 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;...
  • Page 36 40 mm Hg in the oscillometric mode. • The two test measurements are never included in the statistical analysis. They are, however, printed on the report and identified as being test measurements. • Diasys Integra II Manual - GB - Revision 4...
  • Page 37: Manually Activated Measurements

    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...
  • Page 38: Measurements Which Are Not Memorised

    After each measurement the unit displays successively: Standard function: Measurement mode Systolic pressure Diastolic pressure Heart rate Options: Patient's position (if sensor is used) QKd value (if ECG and QKd option are used) • Diasys Integra II Manual - GB - Revision 4...
  • Page 39: Stopping Measurements

    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...
  • Page 40 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). • Diasys Integra II Manual - GB - Revision 4...
  • Page 41: Reading The Recordings

    Reading the recordings 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.
  • Page 42: Modem Transmission

    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. • Diasys Integra II Manual - GB - Revision 4...
  • Page 43 (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). • Diasys Integra II Manual - GB - Revision 4...
  • Page 44: Precautions Of Use

    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...
  • Page 45: Maintenance

    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...
  • Page 46: Replacing The Safeguard Battery

    8.5. Replacing the safeguard battery 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.
  • Page 47: 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).
  • Page 48: Others Precautions Of Use

    • complies with the EN1041 standard in force • 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.
  • Page 49: Physical Specifications

    130 g Storage temperature -20˚C — + 50˚C -20˚C — + 50˚C Functioning temperature +0˚C — + 50˚C +0˚C — + 50˚C Do not store the batteries at over 45°C. • Diasys Integra II Manual - GB - Revision 4...
  • Page 50: Technical Specifications

    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 • Diasys Integra II Manual - GB - Revision 4...
  • Page 51 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 II protective pouch ACC-0506-00 Standard cuff protectors (50) ACC-0450-00...

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