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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

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/

INSTRUCTIONS

FOR USE

Monitor

Device

: DeltaScan Monitor

Doc. Type : Instructions for Use

(English)

System Ver : R2
Date

: 2019-12-12

: 006.201.D

Содержание DeltaScan

Страница 1: ...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 com...

Страница 2: ...ND OFF 9 4 PREPARATION FOR USE 10 5 USE 19 6 AFTER USE 24 7 CHARGING 25 8 MENU 27 8 1 Last 5 Valid Results 27 8 2 Set Language 27 8 3 Start Demo 27 8 4 Exit Menu 27 9 MOUNTING TO A ROLL STAND 26 10 CL...

Страница 3: ...nts not being able to follow measurement instructions see section 1 3 1 2 INTENDED USER USER PROFILE AND USE ENVIRONMENT Intended user is a licensed healthcare physician or other medical professional...

Страница 4: ...1 4 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 M...

Страница 5: ...for Monitor 4 The DeltaScan Monitor should only be used in combination with a DeltaScan Patch See Figure 1 nr 5 and Figure 2 nr 5 To improve fixation of the DeltaScan Patch electrode on the crown of t...

Страница 6: ...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...

Страница 7: ...nical interpretation of DeltaScan s 5 point scale It is recommended to write the Delirium probability or DeltaScan score in the patient file Especially for scores 4 and 5 it is recommended to consult...

Страница 8: ...tached to the rollstand in case the DeltaScan Monitor is mounted to a rollstand 2 2 MEANING OF THE SYMBOLS USED Please note If the label on the Monitor or Patch connector cable or Recording button cab...

Страница 9: ...eltaScan 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 To turn it OFF press either one of the two keys on the Monitor fo...

Страница 10: ...r 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 measureme...

Страница 11: ...uch that a hair free strip of skin is exposed If the patient has hair on the crown of the head to improve electrode contact with the skin it is advised to prepare the crown Make a vertical parting lin...

Страница 12: ...Lock Part 1 and 2 correctly applied Figure 10 a Parting in hair with HairLock correctly applied a strip of skin is exposed in the Hairlock slot Figure 10 b HairLock not correctly applied there is no p...

Страница 13: ...od adhesion on the skin Prolira advises the use of a Dynarex Electrode Skin Prep Pad see Figure 11 a Use this Dynarex wipe to scrub and wipe the skin in the HairLock slot and the skin on the patients...

Страница 14: ...s not past the expiry date Warning Keep DeltaScan Patch dry once removed from its packaging Warning Use DeltaScan Patch on dry skin only Please note In case of wet skin for example caused by sweating...

Страница 15: ...een stripe automatically is at the right position too above the eyebrow See Figure 16 Step 6 Press the 3 electrodes the 3 green stripes and the green logo firmly to the patient s skin for five seconds...

Страница 16: ...ys the screen of Figure 17 Step 8 When the device test was successful the Monitor screen will automatically ask the user to apply and connect the DeltaScan Patch as is displayed in Figure 18 Figure 17...

Страница 17: ...kin Slide the Patch connector over the 3 green triangles up to the line until a hard stop is felt and the Patch cannot advance further See Figure 19 Figure 19 A Point 3 on the DeltaScan Patch position...

Страница 18: ...well attached see Figure 21 Please note In case of repeated mal connection remove the DeltaScan Patch from the patient s head Then start again at step 3 re prepare the skin and apply a new Patch to t...

Страница 19: ...ing the right key on the Monitor close to the word confirm on the screen Step 2 Figure 23 displays the screen that provides the instructions for the start of the measurement The user must hold down th...

Страница 20: ...immediately if the patient does not comply to the instructions Releasing the Recording button means that the EEG measurement is interrupted paused Reasons for releasing the recording button and pausin...

Страница 21: ...y pressing the Recording button again Suggestion The user may be able to support the patient to comply it might help to talk to the patient to provide comfort and encouragement but remember that the p...

Страница 22: ...ce checks every minute whether there is enough progress in gathering good data If at one of these moments max 4 minutes it was not possible to acquire enough useable EEG data from the patient the meas...

Страница 23: ...pressed as 1 2 3 4 or 5 See section 1 5 for an explanation of the scores See Figure 30 for an example of a score It is strongly advised to write the score down in the patient record Do not rely solely...

Страница 24: ...arex 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 S...

Страница 25: ...outlet at the back of the Monitor as indicated in Figure 31 and connect the power plug in the power socket Warning Use the DeltaScan Monitor only in combination with the supplied charger see section 1...

Страница 26: ...ed 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 resta...

Страница 27: ...en will show the next result If less than 5 valid results are stored in the DeltaScan Monitor only the available results are presented 8 2 SET LANGUAGE The DeltaScan Monitor can be set to three differ...

Страница 28: ...ts see Figure 38 that fit into the 2 screw holes in the back of the DeltaScan Monitor Warning Only attach the Monitor to the pole clamp with the right bolt size DIN 912 M4x8 bolts and only use the scr...

Страница 29: ...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 Ha...

Страница 30: ...taScan Patch make a good parting in the hair and use HairLock part 1 and 2 correctly wipe the skin with Dynarex apply Ten20 in the HairLock slot and apply a new DeltaScan Patch Electrode 1 is stretche...

Страница 31: ...or could not get enough useable EEG data in 4 minutes Patient is not relaxed but restless Make sure the patient is calm and in a comfortable position Try another measurement Patient tenses muscles for...

Страница 32: ...ion 11 1 for possible causes and resolutions 5 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 e...

Страница 33: ...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 When the problem remains please contact Proli...

Страница 34: ...SM25E12 P1J REF 006 004 A Monitor Dimensions 111 x 156 x 51 5 mm length x width x height Weight 721 g Protection against Electrical shock Internally powered ME equipment Type BF applied part IP classi...

Страница 35: ...50 60 Hz 0 7 0 35A Output 12V DC 2 08A 25W max Electrical isolation Technical information of the medical adapter SUPPLY MEANS state The circuitry design meets the international medical standard 2x MO...

Страница 36: ...rning Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromag...

Страница 37: ...ight Prolira 13 REFERENCES 1 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 2 T Numan et al Delirium detection using relative delta power...

Страница 38: ...Page 38 14 ANNEX A FULL LABELLING OF DELTASCAN PATCH AND BOX ELECTRODE ELECTRODE P R O L I R A D E L T A S C A N 1 Front label of DeltaScan Patch...

Страница 39: ...oint 2 between thumb and index finger Remove liner Position the electrodes stripe at the center of the forehead above the nose one finger above the eyebrow Hold point 3 and place the cable connector u...

Страница 40: ...Prolira BV Padualaan 8 3584 CH Utrecht The Netherlands support prolira com www prolira com Copyright Prolira BV...

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