GE Novii Clinical Application Manual Download | Manualshive

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Summary of Contents for Novii

Page 1: ...1 Novii Wireless Patch System Clinical Application Guide gehealthcare com ...

Page 2: ...2 ...

Page 3: ...ing Electrodes Skin Preparation 9 Avoiding Skin Redness Reaction 10 Novii Interface Connection 11 Interface Connection Test 11 Interface Pod Connection 12 Troubleshooting Skin Preparation 12 Trace Features 13 Monitoring Screens 14 Main Screen 14 Alerts 15 Ending Monitoring Swapping Pods 16 Patch Removal 16 Interface Troubleshooting 16 FHR Troubleshooting 17 18 FHR Artifact 19 Reassurance 19 UA Tro...

Page 4: ...ternal ECG signal mECG The Pod is indicated for use on women who are at 36 completed weeks in labor with singleton pregnancies using surface electrodes on the maternal abdomen The Novii Patch is an accessory to the Novii Pod that connects directly to the Novii Pod and contains the surface electrodes that attach to the abdomen The Novii Interface is an accessory to the Novii Pod which provides a me...

Page 5: ...n pins avoid contact to prevent damage or debris The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a compatible Maternal Fetal Monitor The Novii Interface enables signals collected and processed by the Novii Pod to be printed and displayed on a compatible Maternal Fetal Monitor and sent on to ...

Page 6: ...an 10 high at 10 C to 30 C 50 F to 86 F Hypoallergenic No latex used in manufacturing Can be worn for up to 48 hours Pod Clip magnetically holds Pod in place Waterproof only when Pod is attached May reinforce electrodes with medical tape or transparent adhesive dressing Pod Clip Novii Patch Pod positioned correctly in Pod Clip Disclaimer Novii works well in shower with splashing but Bluetooth sign...

Page 7: ...ill hide the very small fECG signal from being detected and the FHR will be lost Techniques to minimize electrical noise will improve FHR detection see FHR Troubleshooting Page 17 Novii processes the EMG signals from the myometrium and coverts them in to the typical bell shaped curve contractions Novii is able to distinguish between smooth and striated muscle activity therefore pushing coughing vo...

Page 8: ...ween fundus and pubic bone A general guideline is that the top edge of top electrode should be 4 10cm below the top of the fundus Umbilicus 2 4 6cm Center of uterus 3 If there is a large Pannus covering the pubic area place bottom electrode on top of pannus approximating to the point 2 4 6cm above the estimated pubic bone Wash the area where the Patch will be placed with mild soapy water rinse and...

Page 9: ...n technique using controlled gentle pressure do 3x vertical and 3x horizontal strokes creating a shape Keep exfoliation area to a minimum Hold skin taught if required To accurately place the electrode place the center of the black foam over the center of the exfoliated area Press on outer adhesive edge to secure in place 8 2 4 6cm 9 Repeat steps 4 7 for the remaining 3 electrodes around the clip R...

Page 10: ... increase susceptibility to reactions Correct Patch removal will help reduce skin irritation To remove gently peel each electrode back slowly at a low profile 45 while supporting the skin Do not leave the Patch on for 48 hours Redness caused by over preparation Good skin preparation when first applying the patch will help to avoid skin reactions due to excess exfoliation Do Apply controlled gentle...

Page 11: ...ference 10 15 or 20 is obtained then press 3 FHR MHR and UA test signals are sent from Novii Interface to Fetal Monitor TEST Novii Start Screen Zero UA Screen Fetal Monitor Display Check fetal monitor digital display FHR 120 1 BPM MHR 70 1 BPM and TOCO 105 10 Yes No 4 Check that all signals are displayed and parameters are in range Shake Interface cables to test for intermittent breaks in signal a...

Page 12: ...rface is connected to fetal monitor and Novii test is complete Follow on screen instructions Zero UA press the UA Reference on Fetal Monitor until desired baseline reference is obtained 10 15 or 20 Take a charged Pod If battery indicator is orange low then Pod will not turn on Place Pod on Patch Clip 2 minute count down to place Pod or alarm will sound and Pod will turn off SKIN PREPARTION GOOD WA...

Page 13: ... a new monitoring session 2 Monica Identifier every 5 minutes larger height indicates high UA Sensitivity see pg 20 3 Monica Identifier every 5 minutes smaller height indicates low UA Sensitivity see pg 20 4 Trace is thickened to indicate maternal movement such as ambulation or rocking caution with UA interpretation as UA artifact may be present See page 20 1 2 3 4 ...

Page 14: ... Consider troubleshooting if bad signal is frequent or continuous Increased noise or poor Patch placement may cause poor bad signal quality Foradditional information see How Novii Works page 7 and FHR Troubleshooting page 17 Battery status of active Pod consisting of 8 charge levels lasting 11 hours when full Icon will turn to single orange bar and alert with 60 minutes of charge remaining 4 1 2 3...

Page 15: ...range ask patient to return to room and Novii Pod will automatically reconnect Will also see this message if patient is in tub with Pod submerged 3 Electrode disconnection reattach the electrode indicated medical tape can be used to hold in place if needed If alert continues ensure Pod has good connection to Patch Final solution would be to place a new Patch 4 Multiple electrodes disconnected chec...

Page 16: ...Complete Patch Removal Correct removal will reduce skin irritation Gently peel electrode back slowly at a low profile 45 while supporting the skin Patch is single patient use Dispose of in general waste or in hazardous waste if soiled with blood or bodily fluids per hospital protocol Interface Troubleshooting End any active monitoring by returning the Pod to the Interface Remove the power supply t...

Page 17: ...kin lesion skin fold or umbilicus Avoid stretch marks scars or pronounced linea nigra when possible d If necessary use medical tape or transparent adhesive dressing for added adhesion to prevent electrode lifting or detachment e If electrode site is hairy preventing good contact adhesion it may be necessary to clip the hair SKIN PREPARATION GOOD WAIT REPEAT SKIN PREP REPEAT SKIN PREP ONLY ONCE 2 4...

Page 18: ...Peel the electrode back remove excess gel from skin ensure skin is dry then exfoliate skin and reapply electrode in alternate position b May need to use medical tape to hold in place once new position provides successful signal HELP TIP Remove Pod from Patch place in charging bay and start new monitoring episode HELP TIP Check for damaged Pod pins Carefully clean Pod pins with 70 isopropyl alcohol...

Page 19: ... switching from Novii to an alternative monitoring mode FHR Artifact Due to the challenges of monitoring the fetal heart all fetal monitors are prone to FHR artifact and signal loss Most of the time this artifact is easily identifiable from changes in FHR pattern It is important to view the signal quality on the Novii Interface screen Poor or bad signal quality is more likely to result in FHR arti...

Page 20: ...he uterus causing deflections and the appearance of excessive UA Palpate to confirm In early latent labor or induction myometrial activity is disorganized and preparing to produce pressure changing contractions The electrical signal from this uterine muscle activity may produce small false positive contractions on the Novii UA trace Verify UA with uterine palpation and maternal perception assessme...

Page 21: ...ectly Wiggle cable connector to ensure the monitor input connector is not loose or defective Run a Novii Test to confirm Was UA amplitude high but now low If so has patient changed position Check patch has not moved away from uterus i e high BMI loose skin If needed place pillow under abdomen to support patch back over uterus Confirm Patch is centered on uterus and the center of bottom electrode i...

Page 22: ...m a timing discrepancy of the recorded data Novii should never be mixed with a TOCO IUPC or Scalp fECG as this could lead to misinterpretation of FHR data US should also not be used continuously with or instead of Novii FHR Please see the graphs below for clarification of timing discrepancies that could occur with mixing modalities Using different sources for the MHR from the Corometrics fetal mon...

Page 23: ...d transmission of signals Inspect the Pod pins regularly for debris or damage especially if the Pod is dropped All of the pins should be the same length and feel bouncy when you gently touch them You may touch the pins for inspection purposes only otherwise avoid contact Debris collection around the Pod pins may not allow them to move freely Follow the cleaning instructions above to clean the Pod ...

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Page 25: ...ealthcare Ltd Notice The materials contained in this document are intended for educational purposes only Always refer to the Instructions for Use provided with the device for specifications operating procedures and maintenance requirements JB52979XXb 06 18 Monica Healthcare Limited E mail novii info ge com www monicahealthcare com www gehealthcare com 2017 General Electric Company All rights reser...

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