Novii - FHR Gaps Troubleshooting Guide 107-PT-008-USRev1

FCC ID: YOM-6961-MON

Users Manual

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                                                   FHR Gaps Troubleshooting Guide
               POSSIBLE CAUSE                                                             ACTION & SOLUTION1

           1                                          l Return patient to bed
                                                      l Consider using a maternity belt to support pannus during
                                                        ambulation or upright position
                                                                                                            2.4"/6cm
                                                        HELP/TIP
                                                        a) Allow 10-15 minutes of monitoring before starting ambulation.                                       1"/2-3cm
                                                                                                                                                              1"/2-3cm
                                                        b) The patient should not be encouraged to ambulate unless the FHR
                                                           trace is good and the signal indicator on the Novii Interface shows
                                                                                                                          2.4"/6cm
                                                           3 green squares.                                              2.4"/6cm      Signal
                                                                                                                                                             1"/2-3cm
           The patient is ambulating

                                                      l Use a pillow behind back or head                              2.4"/6cm
           2
                                                        to make patient more comfortable
                                                      l Return patient to a position where                                                                       1"/2-3cm
                                                        Novii worked well                                                                                       1"/2-3cm

                                                      l Encourage patient to lie on left or right
                                                      l If patient on side, support abdomen with                                                              1"/2-3cm
                                                        a pillow/rolled blanket to re-position
                                                        abdomen so that the Patch is centred                                                                      SKIN PREP
           Patient position/posture
                                                        over the uterus                                                                      SKIN PREPARATION GOOD
                                                                                                                                            SKIN PREPARATION GOODREPEAT SK
                                                                                                                                             REPEAT SKIN PREP
                                                                                                                                            REPEAT SKIN PREP     REPEAT SK
           3                                          l Check electrodes and move or stick back down                                         REPEAT SKIN PREP    DO NOT BY
                                                                                                                                            REPEAT  SKIN PREP
                                                                                                                                             DO NOT BYPASSGOOD
                                                                                                                                          SKIN
                                                                                                                                            DOPREPARATION
                                                      l Re-position Patch or electrode to avoid the skin problem                               NOT BYPASS
                                                                                                                                          REPEAT SKIN PREP
                                                        HELP/TIP
                                                                                                                                          REPEAT SKIN PREP
                                                        a) The Interface will alert user with a visual message, but only when electrode isDOfully
                                                                                                                                             NOT detached.
                                                                                                                                                  BYPASS
                                                        b) Check electrodes after a shower, clinical procedure, ambulation or position change.
                                                        c) Electrode(s) should not be placed over a skin lesion, skin fold, umbilicus, stretch mark,
                                                           pronounced linea nigra.
                                                        d) If necessary use a strip of micropore tape to prevent electrode lifting or detachment.
   Electrode ‘detached’ or makes
       poor contact with skin

           4                              FHR         l Check Interface for help message
                                          FHR                                                             FHR
                                          MHR         l Interface is off
                                        FHR
                                          MHR                                                             MHR
                                          UA            HELP/TIP
                                         FHR
                                          UA                                                              UA
                                        MHR             a) If Interface has lost power Bluetooth pairing with POD is lost.
                                             MHR          Remove POD from Patch, place in charging bay and start new monitoring
                                        UA                episode when power is returned.
                                             UA
                                  1"/2-3cm              b) Interface does not have a battery back-up.

2.4"/6cm
               Lost MHR and UA                        l Start-Screen is displayed
                      as well as FHR                    HELP/TIP
                                                        POD has switched off – remove POD from Patch and place in charging well.
                                                        Start new monitoring session with other POD.
                                   1"/2-3cm
                                                      l Faulty ‘Y’ Connector - replace

           5
                                                      l Exfoliate skin under ‘bad’ electrode
                                                        HELP/TIP
               SKIN PREPARATION GOOD

               REPEAT SKIN PREP
                                                        a) Peel the X electrode back, remove excess gel from skin and finish with alcohol wipe.
               REPEAT SKIN PREP
                                                           Wait until skin is dry then exfoliate skin and reapply electrode.
               DO NOT BYPASS
                                                        b) May need to use micropore tape to hold in place.

                                                      l Restart the monitoring session if location of ‘bad’ electrode not known
                                                        HELP/TIP
          Bypassed red X on                             Remove POD from Patch, place in charging bay and start new monitoring episode.
     electrode/skin checkscreen


                     POSSIBLE CAUSE                                                                                  ACTION & SOLUTION1

               6                                                       l Re-position electrode
                                                                               1"/2-3cm
                                                                           HELP/TIP                1"/2-3cm
                                           2.4"/6cm                        a) Peel the electrode back, remove excess gel from skin and finish with alcohol wipe.
                                                                              Wait until skin is dry then exfoliate skin again and reapply electrode in correct position.
                                                         2.4"/6cm
                                                                           b) May need to use micropore tape to hold in place.




                 Lower electrode is not                                            1"/2-3cm
                  2.4"/6cm above the                                                                1"/2-3cm
                   symphysis pubis

                                                                       Pannus covering Symphysis Pubis
               7                   1"/2-3cm
                                                                       l Remove electrode and place it lower or higher on the abdomen
                                                            SKIN PREPARATION GOOD
2.4"/6cm                                                    REPEAT SKIN PREP
                                                                       l Alternatively         place electrode just below the point where
                                                                           SKIN PREPARATION GOOD
                                                            REPEAT SKIN PREP
                                                            DO NOT BYPASSthe surface curves back on itself ensuring that the electrode
                                                                             REPEAT SKIN PREP
                                                                         isREPEAT
                                                                             notSKIN
                                                                                   folded
                                                                                      PREP
                                                                               DO NOT BYPASS
                                       1"/2-3cm


               Lower electrode may not
                 be optimally placed2
                SKIN PREPARATION GOOD

               8REPEAT SKIN PREP                                       l Plug in US transducer for short                                     l Swap back to conventional
                REPEAT SKIN PREP                                         FHR ‘filling’ and reassurance                                         monitoring modalityNovii FHR
                                                                                                                                                                  (10 sec delay)
                DO NOT BYPASS
                                                                                                                                                                                 US FHR
                                                                          HELP/TIP
                                                                                     WARNING: Novii UA/MHR delayed
                                                                               !     10 seconds (5mm) from US FHR - see panels below              10 sec
                                                                                                                                                                                 Novii MHR
                                                                                                                                                                                 (10 sec delay)


                                                                                                                                                                                 Novii UA
                                                                                      Using US FHR with Novii UA could                            Using TOCO UA with Novii FHR(10could
                                                                                                                                                                                  sec delay)

                                                                                     make a late deceleration appear early                       make an early deceleration appear late
                                                                                                                                                                               Novii FHR
                                                                                                                       Novii FHR
                    None of the above                                                                                  (10 sec delay)
                                                                                                                       US FHR
                                                                                                                                                                               (6 sec delay)




                                                                                                                                                                               Novii MHR
                                                                                                                       Novii MHR                                               (6 sec delay)
                                                                                     10 sec
                                                                                                                       (10 sec delay)             10 sec
                                                                                                                                                                               TOCO/IUPC UA –
                                                                                                                                                                               real-time
                                                                                                                       Novii UA                                                Novii UA
                                                                                                                       (10 sec delay)                                          (6 sec delay)

                                                                                    Novii FHR/MHR/UA are synchronised                              Novii FHR/MHR/UA are synchronised
                                                                                but all trace 5mm (10 sec) behind Novii
                                                                                                                  US FHRFHR trace.            but all trace 3 mm (6 sec) behind TOCO UA trace.
                                                                                                                     (6 sec delay)

                                                                                              10 Second Trace Example                                      6 Second Trace Example
                                                                                                                     Novii MHR
                                                                                                                     (6 sec delay)
           High/Low UA Sensitivity Explained                                         10 sec
                                                                                                                     TOCO/IUPC UA –
                                                                                                                     real-time
                                                                                                                     Novii UA
                                                                                                                     (6 sec delay)


                                       UA High         UA Low




           8                       9              10              11                   12               13                14            15                 16            17                 18
                                                                                                    Data (minutes)

           Selecting UA Low sensitivity from the Novii display will decrease the UA trace amplitude, suppressing unwanted low amplitude
           UA, but it will also reduce the contraction duration. There will be no change to the location of the peak.
           Low amplitude UA is considered to be due to artefact from fetal/maternal movement and unsynchronised myometrial activity.


           Notes:
           This troubleshooting guide assumes that the patient is supine or semi-supine during Patch placement and Novii set-up.
           1. ! CAUTION: any intervention will take 10 seconds before its impact will be seen on the trace.
           2. The user is familiar with the placement of Patch and lower mid-line electrode in high BMI patients with a pannus.                                                 107-PT-008-USRev1



Document Created: 2016-02-08 16:08:55
Document Modified: 2016-02-08 16:08:55

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