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Prolira DeltaScan Instructions For Use Manual

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INSTRUCTIONS
FOR USE
Monitor
Disclaimer
The DeltaScan Monitor is intended for use by healthcare professionals in a clinical setting,
who are fully responsible to use the device in accordance with these Instructions for Use.
The manufacturer Prolira BV can in no way be held liable if the DeltaScan Monitor is
incorrectly used, is not maintained, is poorly maintained, is incorrectly set, or is used by
unqualified persons.
These Instructions for Use may not be reproduced or used in any way without the prior written
permission of Prolira BV. All rights reserved. Subject to alteration.
The compatible hardware and software versions for the DeltaScan Monitor that are subject
of this Instructions for Use can be found in the compatibility Matrix on the Prolira website
location http://prolira.com/ifu-prolira-deltascan/
Device
: DeltaScan Monitor
Doc. Type : Instructions for Use
(English)
System Ver : R2
Date
: 2019-12-12
: 006.201.D

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Summary of Contents for Prolira DeltaScan

  • Page 1 Instructions for Use. The manufacturer Prolira BV can in no way be held liable if the DeltaScan Monitor is incorrectly used, is not maintained, is poorly maintained, is incorrectly set, or is used by unqualified persons.

  • Page 2: Table Of Contents

    Transport And Storage 10.3 Maintenance POSSIBLE PROBLEMS DURING USE 11.1 Problems, Causes And Solutions 11.2 Errors And Warnings That Can Be Presented On the Monitor Screen TECHNICAL AND REGULATORY INFORMATION REFERENCES ANNEX A: FULL LABELLING OF DELTASCAN PATCH AND BOX Page 2...

  • Page 3: Introduction To The Deltascan Monitor

    This implies that the patient is to be screened with the DeltaScan Monitor, meaning detection and monitoring for delirium is applied.

  • Page 4: The Deltascan Monitor Components

    THE DELTASCAN MONITOR COMPONENTS 1) Monitor 2) Patch connector 3) Recording button 4) Charger for Monitor 5) The DeltaScan Monitor should exclusively be used with a DeltaScan Patch. Figure 1: DeltaScan Monitor Components. Page 4...
  • Page 5 HairLock from the dispenser-box (see Figure 2: nr 7) The DeltaScan Monitor can be mounted to a GCX Rollstand (see Figure 2: nr 6), (see also section 9). Figure 2: DeltaScan Monitor complete set-up. Copyright: Prolira Page 5...

  • Page 6: Operating Principle And Delirium Probability Score

    The acquired EEG signals are amplified, digitized, and processed by the software algorithms of the DeltaScan Monitor, to present a Delirium Probability or DeltaScan Score to the user. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.
  • Page 7 These patterns differ from healthy EEG recordings. The DeltaScan Monitor provides the user with the DeltaScan Score on a scale of 1 to 5. Table1 explains the technical meaning and clinical interpretation of DeltaScan’s 5-point scale.

  • Page 8: How To Use These Instructions For Use

    In the event of problems, please consult section 11 ‘Problems during use’. Please note! Always keep a copy of the Instructions for Use near the DeltaScan Monitor (for example attached to the rollstand, in case the DeltaScan Monitor is mounted to a rollstand).

  • Page 9: Turning On And Off

    Doc. Type : Instructions for Use Date : 2019-12-12 (English) : 006.201.D TURNING ON AND OFF The DeltaScan Monitor does not have an ON/OFF switch. It turns ON by briefly pressing either one of the two keys on the Monitor (see Figure 5). right...

  • Page 10: Preparation For Use

    Recording button cable (REF: 006.902.A) plugged in. • a Charger (REF: 006.004.A) for the DeltaScan Monitor, to be used in case the battery level is too low to take a measurement. Figure 6 below indicates the location of the user, the patient, and the DeltaScan Monitor during a measurement on a patient in bed.
  • Page 11 For a correct measurement with DeltaScan, carry out the following preparation steps, to apply a single use DeltaScan electrode Patch correctly to the patient’s head. Please note! The labelling of the DeltaScan Patch is included in full in Annex A. Step 1: Determine the crown on the head •...
  • Page 12 HairLock part 2 • Slide Hairlock part 2 over part 1 align and press for fixation. Figure 9: HairLock Part 1 and 2 correctly applied. Figure 10.a: Parting in hair, with HairLock correctly applied: Figure 10.b: HairLock not correctly applied, a strip of skin is exposed in the Hairlock slot.
  • Page 13 Step 3: Prepare the skin of the patient for a good EEG • To ensure a good EEG with DeltaScan, it is important to ensure good electrode contact with (good adhesion on) the skin. Prolira advises the use of a Dynarex Electrode Skin Prep Pad (see Figure 11.a.).
  • Page 14 Please note! The DeltaScan Patch must not yet be connected to the DeltaScan Patch connector. • Hold point 1 of the DeltaScan Patch between thumb and index fi nger. Remove the liner from the back of point 1, as indicated in Figure 13. •...
  • Page 15 Figure 15: Remove the liner while holding one finger above the eyebrow. point 2 of the DeltaScan Patch. The triangle shape of the DeltaScan Patch (under the green stripe) points towards the nose. The other electrode (green stripe) automatically is at the right position too, above the eyebrow.
  • Page 16 Step 7 Turn the DeltaScan Monitor ON. Wait until the ‘device test’ is completely run. While running the ‘device test’, the Monitor displays the screen of Figure 17. Step 8 When the device test was successful, the Monitor screen will automatically ask...
  • Page 17 See Figure 19. Figure 19: Point 3 on the DeltaScan Patch (positioned on the right cheek of the patient) with indication for inserting the Patch into the Patch connector. Hold the Patch connector between thumb and index fi nger.
  • Page 18 Patch to the patient. Then reattach the Patch connector, until the Connection-LED turns green. Please note! It may require a little force to insert the DeltaScan Patch into the Patch connector. Figure 21: Monitor screen when Patch and electrodes are well connected.

  • Page 19: Use

    Device : DeltaScan Monitor System Ver : R2 Doc. Type : Instructions for Use Date : 2019-12-12 (English) : 006.201.D Step 1 Once all preparation steps have been carried out properly, the Monitor displays the screen of Figure 22. The user is asked to read the instructions “Hold down the recording button...
  • Page 20 Step 3 IMPORTANT: measure only if the patient complies to the instructions! A successful DeltaScan measurement takes about 2 minutes, but sometimes a measurement may take longer. It is very important that the patient follows the instructions during the entire measurement. Following the instructions means that the patient: •...
  • Page 21 Device : DeltaScan Monitor System Ver : R2 Doc. Type : Instructions for Use Date : 2019-12-12 (English) : 006.201.D When the user releases the recording button, the measurement is PAUSED. This is made clear by: • The strip of LEDs in the Patch connector, that blinks orange (see Figure 25.a)
  • Page 22 Please note! The user can stop a measurement anytime during a recording, by pressing the left key on the DeltaScan Monitor. In this case, it is not possible to continue the measurement. Page 22...
  • Page 23 In relation to defi brillation Warning! Remove the DeltaScan Patch and the DeltaScan Monitor from the patient before applying defi brillation Warning! Replace the DeltaScan Patch if it has been on the patient during Warning! defi brillation. Copyright: Prolira...

  • Page 24: After Use

    Dynarex wipe. Warning! Remove the DeltaScan Patch immediately from the patient’s head, after measurement. Please note! The DeltaScan Monitor switches OFF automatically if is it not used for 5 minutes. Step 2 Store the DeltaScan Monitor on a convenient location.

  • Page 25: Charging

    : 2019-12-12 (English) : 006.201.D CHARGING The DeltaScan Monitor is designed such that is can operate for 48 hours without charging under normal clinical conditions (i.e. about 60 measurements can be taken). It is, however, advised to charge the battery daily, to make Power outlet sure that the device is always ready for use.
  • Page 26 When the charger is unplugged, the device needs a restart. Instructions are displayed on the screen (see Figure 34). If the battery is not full enough to take a measurement, the following screen is displayed (see Figure 35). Figure 34: Monitor screen displaying that the device needs a restart after charging.

  • Page 27: Menu

    ). By pressing the right key, the user can go to the next demo screen. EXIT MENU When the option “Exit menu” is activated by the user, the DeltaScan Monitor will return to Step 7 (Preparations for use, device test when starting the device up). Copyright: Prolira...

  • Page 28: Mounting To A Roll Stand

    MOUNTING TO A ROLL STAND It is advised to mount the DeltaScan Monitor to a rollstand. The proper way of doing this is to use a GCX pole-clamp type PH 0062 82B and two DIN 912 M4x8 bolts (see Figure 38), that fi t into the 2 screw holes in the back of the DeltaScan Monitor.

  • Page 29: Cleaning, Storage, And Maintenance

    10.2 TRANSPORT AND STORAGE Store the DeltaScan Monitor in a dry room. For practical reasons, it is advised to mount the DeltaScan Monitor on a roll stand. The recommended GCX lightweight roll stand with 2 baskets can not only accommodate the DeltaScan Monitor on the pole clamp, but also the DeltaScan Patches, the Charger and accessories like HairLocks.

  • Page 30: Possible Problems During Use

    Excessive sweating of patient detaches from the the skin, use a Dynarex wipe again patient’s skin (the and apply a new DeltaScan Patch. Connection-LED on The use date of the DeltaScan Apply a new DeltaScan Patch with the Patch connector is Patch is passed the expiry date a valid expiry date.
  • Page 31 Solution(s) The DeltaScan Monitor The charger is not plugged in in Check charging procedure in is not being charged the DeltaScan Monitor and/or wall chapter 7 ‘Charging’. power socket The charger is defective Use another DeltaScan charger, or contact Prolira.

  • Page 32: Errors And Warnings That Can Be Presented On The Monitor Screen

    If after three attempts, the device was still not able to acquire enough useable EEG data in 4 minutes of measuring. Please contact Prolira to share your experience. Prolira can learn from it, and improve the device. Possible hardware failure.
  • Page 33 DeltaScan Monitor. In that case please contact support@prolira.com When the DeltaScan Monitor is turned ON, it automatically runs a device test. A failing device test may have several causes. First, try pressing any button to reboot the monitor.

  • Page 34: Technical And Regulatory Information

    Use only with DeltaScan Patch (REF: 001.000.A) The compatible hardware and software versions for the DeltaScan Monitor that are subject of this Instructions for Use can be found in the compatibility Matrix on the Prolira website location http://prolira.com/ifu-prolira-deltascan/ Charger AC/DC Medical Adapter Type: Mean Well, GSM25E12-P1J (REF: 006.004.A)
  • Page 35 (2x MOPP), having an ultralow leakage current (<50µA), fitting the medical devices in direct electrical contact with the patients.” In addition, the design of the DeltaScan Monitor electronics prevent operation of the device when the charger is connected. Copyright: Prolira...
  • Page 36 EMC compliance The DeltaScan Monitor has an essential performance according to EN 60601-1-2:2015. Under infl uence of EMC disturbance, DeltaScan will not provide a wrong result. It might present no result at all. The DeltaScan Monitor is compliant with EN 60601-1-2:2015 for immunity in professional healthcare facility and residential environments.

  • Page 37: References

    Device : DeltaScan Monitor System Ver : R2 Doc. Type : Instructions for Use Date : 2019-12-12 (English) : 006.201.D REFERENCES A. W. Van Der Kooi et al., “Delirium detection using EEG: What and how to measure,” Chest, vol. 147, no. 1, pp. 94–101, 2015.

  • Page 38: Annex A: Full Labelling Of Deltascan Patch And Box

    ANNEX A: FULL LABELLING OF DELTASCAN PATCH AND BOX 1) Front label of DeltaScan Patch Page 38...
  • Page 39 Device : DeltaScan Monitor System Ver : R2 Doc. Type : Instructions for Use Date : 2019-12-12 (English) : 006.201.D 2) Back label of DeltaScan Patch Copyright: Prolira Page 39...
  • Page 40 Prolira BV Padualaan 8, 3584 CH, Utrecht, The Netherlands support@prolira.com Copyright: Prolira BV www.prolira.com...

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