GE Novii User guide

1
Novii™Wireless
Patch System
Clinical Application Guide
gehealthcare.com

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Contents
Introduction .......................................................................4
Device Description...........................................................4
Indications for Use...........................................................4
Contraindications ...........................................................4
Expectations ................................................................4
Device Components ...............................................................5
Novii Pod ....................................................................5
Novii Interface...............................................................5
Novii Patch ..................................................................6
How Novii Works ..................................................................7
Applying the Novii Patch...........................................................8
Before Placing Novii Patch ...................................................8
Placement of Patch ..........................................................8
Applying 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 Troubleshooting ...............................................................20–21
Timing.............................................................................22
Mixed Modality Monitoring ........................................................22
Cleaning...........................................................................23

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Introduction
GE Healthcare aims to provide you with the best training available and support you in the
clinical use of your Monica Novii Wireless Patch System. This application guide is designed
to provide an overview of Novii as well as provide clinical guidelines of how and when to use
Novii. This application guide is not a substitute for clinical on-site training offered by
GE Healthcare and its representatives. Additional training resources are available at
www.gehealthcare.com/noviitraining
Novii Description
The Monica Novii Pod Fetal-Maternal Monitor is designed as an ambulatory device for the
monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological
signal to be picked up from three different positions on the maternal abdomen using
the 5 electrodes on the Monica Novii Patch. The monitor filters the abdominal signals,
converts the abdominal electrophysiological data into a digital format and then processes
it in real time to extract the fetal heart rate, maternal heart rate and uterine activity.
The result of the processing is transmitted via the Bluetooth connection to the Monica
Novii CTG Interface device that is a Monica Approved accessory to the Monica Novii Pod.
Indications for Use
The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively
measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart
rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface
electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes,
the Pod also acquires and displays the UA tracing from the uterine electromyography
(EMG) signal and the MHR tracing from the maternal 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 means of interfacing the wireless output of the Novii Pod to
the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected
by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a
central network, if connected. The Novii Pod maternal-fetal monitor and its accessories
are intended for use by healthcare professionals in a clinical setting
Contraindications
The Novii should not be used with antepartum, preterm (≤36 completed weeks)
and multiple pregnancies. In addition, the Novii should not be used with equipment
that introduces electrical energy in to the body i.e., Transcutaneous Electrical Nerve
Stimulation (TENS), cardiac pacemakers, cardiac defibrillators, MRI scanners, CT scanners
and diathermy/electro surgery equipment. Recommend only using Novii with monitoring
systems that have been certified for compatibility for use with Novii by GE Healthcare.
Expectations
Novii provides advanced monitoring for the majority of laboring women, however like
other forms of fetal monitoring, in a small number of women, there may be the need to
switch to a different monitoring method if the FHR signal quality is indicated as poor or
bad. Novii enables in room ambulation and potentially beyond – up to 100ft/30m.
The actual distance of ambulation my vary. Most women are able to walk with good FHR
signal quality, while others may find they will need to modify their activity or position to
allow Novii to work best for them.
Novii Interface
and Pods
Novii Patch

5
Novii Device Components
The Novii Pod processes the fECG, mECG & EMG signals and
communicates via Bluetooth with the Novii Interface.
Novii Pod Features
• Up to 11 hours battery life*
• 2 Hour charge time
• Monitors FHR, MHR & UA
• Communicates signals to Novii Interface via Bluetooth
• Bluetooth wireless range 100 ft / 30 m
• Attached by magnets to Novii Interface charging bay or Patch**
while in use
• Waterproof only when Pod is attached to Patch
1. Two blue LED lights located on the Novii Pod indicate:
• Charging: Single LED flashes slowly
• Fully Charged: Single LED on constant, then turns off in
stand-by mode
• Pod On/Active: Both LEDs flash, alternately
• Connected to Patch: Both LEDs on constant
• Monitoring: Both LEDs flash slowly in unison
2. Connection 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 a central network, if connected.
Interface Features
1. Touch Screen Display
2. Wireless Charging Bays (x2)
3. Power Supply Connection
4. UA/TOCO Cable Connection
5. mECG Cable Connection
6. fECG Cable Connection
7. COM Port [Service Use Only]
1
2
1
2
UA/TOCOPSU MECG FECG COM
3 4 5 6 7
Novii Pod
Side view
Novii Interface
Rear panel view
*Varies per use depending on Bluetooth range
**Disclaimer: Novii works well in shower with splashing, but Bluetooth signal cannot transmit and all signals will be lost if
Pod is submerged under water in a tub.

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The Novii Patch is an accessory to the Novii Pod and contains the
surface electrodes that attach to the maternal abdomen. The Novii Pod
connects directly to the Novii Patch via the Pod Clip while in use.
Patch Features
• Single patient use
• Maximum 12 month shelf life. Store flat, no more than 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 signal cannot transmit and all signals will be lost
if Pod is submerged under water in a tub.

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How Novii Works
Novii electrodes work in pairs to create channels that detect the
Fetal ECG, Maternal ECG and electromyography (EMG) signals from
the uterine muscle.
• Electrode 4 is the ground electrode and important for reducing
electrical noise from the body
• Electrode 5 is most critical for FHR
• Electrode 3 is most critical for UA
Minimal Confusion – the mECG and fECG are simultaneously monitored
and their size and shape make them distinctly different allowing them to
be easily separated to avoid confusion.
Accuracy – Novii uses the R-R intervals of the ECG waveform to calculate
the FHR and MHR.
Noise – when electrophysiological noise from the body or electrical
noise from the environment becomes too big it will 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, vomiting, and fetal kicks will not be reflected
on Novii UA.
During labor, Novii accurately and reliably displays contraction frequency
and timing of contraction nadir. Novii does not display a measurable
contraction strength or resting tone. Contraction duration may differ
slightly as compared to TOCO & IUPC. Use uterine palpation to confirm,
as per standard practice with other UA monitoring devices.
2
13
5
ECG Channels (FHR/MHR)
2
4
1 3
5
EMG Channels (UA) EMG
Novii UA
IUP
TOCO
mECG
fECG
Noise
Maternal
R-R Fetal
R-R
4

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Applying the Novii Patch
Place the Novii Patch before
connecting Novii Interface
to fetal monitor, to allow
gel time to absorb in to
the skin.
1
2
Remove backing from Pod
Clip. Place the Pod Clip on the
midline over the umbilicus
(center of the uterus).
Arrow pointing towards
patient’s head.
Umbilicus
Center of uterus
2.4”
6cm
3
Center of bottom electrode
is placed 2.4” / 6cm above
(towards the patient’s head),
the top rim of pubic bone.
Typically, this is just above
the hairline.
Standard Patch Placement
Umbilicus
2.4”
6cm
Center
of uterus
2
Displaced Umbilicus – DO
NOT place Pod Clip on
umbilicus. Find center of the
uterus and place Pod Clip,
i.e. midway between 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 ensure
the area is dry. Do not use
hospital grade anti-microbial
soaps which may contribute to
adverse skin reactions.
Before Placing Novii Patch
The Novii Patch is Latex
Free, however ask if
the patient has any
other allergies or skin
sensitivities that might
prevent the Patch from
being used.
LATEX
Check Patch expiration date.
If Patch is opened but not
used, may reseal, date and
use within 30 days.
Patients with Displaced Umbilicus and/or PannusOR

9
Applying Electrodes/Skin Preparation
4 5
Lift up one of the electrodes
around Pod Clip and remove
the protective cover. (Do not
exfoliate skin under center
Pod Clip).
Focusing on the area of skin
below black foam, use skin
prep tape to exfoliate (remove
dead skin cells). Use one piece
of 1” / 2cm skin prep tape for
every 2–3 electrodes.
6 7
Exfoliation 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.
Repeat steps 4–7 for bottom
electrode, ensuring center of
electrode placement is 2.4” /
6cm above top rim of pubic
bone. (See pictures in steps 2
and 3).

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Avoiding Skin Redness/Reaction
Application of electrodes on patients may result in some skin irritation or redness upon removal, but usually subsides within
24 hours and will leave no permanent marks.
10 minutes after Patch removal
Assess patient for skin allergies and sensitivities. Inform her that redness can occur and there is a low risk for an
adverse skin reaction.
Patient may report a tingling sensation or itching when the Patch is first applied, but this should subside in 15-30 minutes.
If this worsens, assess for an allergic reaction by lifting an electrode. The electrode directly below the Patch Clip will have
minimal interference with monitoring if lifted. Remove Patch immediately if allergic reaction is noted. Avoid use of isopropyl
alcohol or strong soaps on the skin, which dries out the patient’s skin and may 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pressureduringexfoliation
•Keepexfoliatedareatoaminimum
•Ensureblackfoamareaofelectrodeisplacedaccuratelyovercenter
of exfoliated skin, which avoids having to repeat preparation
Do NOT:
•Applyexcesspressureduringexfoliation
•Applytoolittlepressureduringexfoliationasitwillleadtoneedingto
prepare the skin again
•Preparetheskinmorethantwice.Usebypassbutton ifneeded
(accuracy of the monitoring will be unaected)
6 hours after Patch removal 24 hours after Patch removalCorrect removal will reduce skin
irritation: Gently peel electrode
back slowly at a low profile
(<45°), while supporting the skin.

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Novii Interface Connection
Interface Connection Test
1. fECG Interface Connection Cable 2. mECG Interface Connection Cable 3. UA Interface Connection Cable 4. Power Supply Cable
5. Y Adapter Cable – needed for GE 259 monitors
UA/TOCOPSU MECG FECG COM
3 1 2
4 3 2 1
TEST
1. PLACE PATCH ON ABDOMEN
2. ZERO UA ON FETAL MONITOR
3. TAKE AN AVAILABLE POD
?
Midline
Umbilicus
AC power
Rear View
MECG
Print Freeze Alarms Setup VSHX
15:52:58
25 mm/s
2x
II
NIBP MECG MSpO2
US
FECG TOCO
HBC
98
70
120
4
Zero UA on fetal monitor
1. On Novii Interface start screen
press
2. Zero UA (press the UA Reference) on
Fetal Monitor until desired baseline
reference (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 and
replace cable if needed. If signals
are missing, check that connections
are secure.
Novii Test Screen
Press Settings icon to access
the settings
?
Settings Display Screen
Help Display Screen
Instructions For Use and
training videos are available from
www.monicahealthcare.com/training
SELECT LANGUAGE ENGLISH
ABOUT
DISPLAY MHR ON INTERFACE DISABLED
AUDIO ALERTS DISABLED
UPGRADE INTERFACE
UPGRADE POD
Press Help icon to access
?
5

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Monitoring screen will automatically appear once skin preparation
of all 5 electrodes is good.
Interface/Pod Connection
Troubleshooting Skin Preparation
SKIN PREPARATION GOOD
REPEAT SKIN PREP
REPEAT SKIN PREP
DO NOT BYPASS
Electrode Check Screen
indicates whether the
skin preparation has
been sucient – to
resolve a Xor Ofollow
steps on right:
Step 1 Press down on center of electrode
to ensure good skin contact – then wait
10–20 seconds for gel to absorb. If Xor O
remain proceed to Step 2.
Step 2 Lift problem electrode, wipe gel
from skin and repeat exfoliation with new
piece of prep tape. (See page 9)
Step 3 Only re-exfoliate the skin once and
if Xor Oremain then bypass.
TEST
1. PLACE PATCH ON ABDOMEN
2. ZERO UA ON FETAL MONITOR
3. TAKE AN AVAILABLE POD
?
Midline
Umbilicus
Ensure Novii Patch is placed, Interface 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
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
Signal
Battery
Patch 3458
UA
Monitoring
SKIN PREPARTION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
Signal
Battery
Patch 3458
UA
Monitoring
Be patient while awaiting signals to acquire and record. Signals may take anywhere from 5 seconds to 2 minutes to be detected
and displayed. FHR may take additional time. Use the ultrasound transducer as needed for reassurance while waiting. Attempt to
troubleshoot if no FHR or poor signal after approximately 5 minutes. Wait for 10-15 minutes worth of good FHR signal quality before
encouraging the patient to ambulate.

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Trace Features
Note: Trace is displayed with print speed at 1cm/minute or 3cm/minute. Slower speeds will compress appearance of images.
1. Monica Mark (at the start of a new monitoring session).
2. Monica Identier (every 5 minutes) – larger height indicates high UA Sensitivity (see pg.20).
3. Monica Identier (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
34

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Monitoring Screens
Main Screen
1. FHR signal performance during monitoring – indicates quality of fECG detection.
Note: this is NOT correlated to the Bluetooth signal.
Signal
Battery
Pod AA0098
UA
5
Good Signal Quality – Expect
continuous FHR tracing.
Poor Signal Quality – FHR extraction
may be compromised, with possible FHR
gapping and/or artifact. Be cautious in
interpretation and seek conrmation,
see FHR Artifact on page 19.
Bad Signal Quality – No fECG can be
extracted and FHR gapping or artifact
is to be expected. Use ultrasound
transducer to obtain/conrm
FHR for short durations. Consider
troubleshooting if bad signal is frequent
or continuous. Increased noise or poor
Patch placement may cause poor/bad
signal quality. For additional 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
6
Sound Alerts
Enabled
Sound Alerts
Disabled
High UA
Sensitivity
UA UA
Low UA
Sensitivity
or or
2. Pod battery status while in use
3. Serial number of Pod in use
4. Pod battery status when docked
5. MHR display (option in settings menu) / Alerts / Support Messages
6. User controls
(Enabled/disabled in Settings, see pg. 11) (For information, see pg. 20)
*Varies per use depending on Bluetooth range

15
Alerts
Signal
Battery
Pod AA0098
UA
Battery low: Remove POD
from Patch and dock
Signal
Battery
Pod AA0098
Patient Out of Range
Signal
Battery
Pod AA0098
UA Check Electrode(s)
Signal
Battery
Pod AA0098
UA Check Electrode(s)
Signal
Battery
Pod AA0098
UA Check Electrode(s)
Signal
Battery
Pod AA0098
UA Check Electrode(s)
Signal
Battery
Pod AA0098
UA MHR/FHR are coincident
MHR
89
Signal
Battery
Pod AA0098
UA MHR/FHR are coincident
MHR
89
Signal
Battery
Pod AA0098
PATCH NOT GENUINE
1. Return Pod to Interface
2. Replace with a Monica
branded Patch
1. Low battery - see instructions for swapping Pods (Page 16). 2. Patient out of 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 – check all electrodes to
ensure good connection to skin. See #3. If continues, check
Pod pins and the Patch connection at center of Pod Clip for
damage and dirt, or try a dierent Pod.
5. MHR and FHR are coincident (+/-10 BPM for more than 60
seconds). Only occurs when ‘Display MHR on Interface’ option is
enabled.
6. Non-genuine Patch used or connection problem. Try restarting
the monitoring with a dierent Pod or use a dierent Patch.

16
Ending Monitoring/Swapping Pods
1 2
Remove Pod
from Patch.
Return Pod to Interface,
then wait for battery icon
to be displayed above Pod
(Monitoring Ended).
3 4
Once battery icon of returned
Pod is displayed, zero the UA,
then take fully charged Pod
from Interface (if new Pod
taken too soon it will not
turn on).
Place a charged Pod
on Patch (Swapping
Pod Complete).
Patch Removal
Correct removal will reduce
skin irritation: Gently peel
electrode back slowly at
a low prole (<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 then reconnect it to restart
the Interface. Then run the Interface connection test (see page 11), to confirm the correct setup and function of the Interface.

17
FHR Troubleshooting; when signal quality is poor or bad
POSSIBLE CAUSE/PROBLEM ACTION & SOLUTION
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
2
Patient position/posture -
may cause muscle tension/
noise and/or displaced Patch
•Adjustpatient’sposition:headofbedup/down,right/lefttilt.
•Useapillowbehindbackorheadtomakepatientmore
comfortable, encouraging patient to relax abdominal muscles.
•ReturnpatienttoapositionwhereNoviiworkedwell.
•IfpatientishighFowler’sorinacurledsittingpositionfor
epidural placement, consider placing a rolled towel or
baby blanket under the abdomen for support to ensure
optimal position of the lowest electrode.
•Ifpatientisonside,supportabdomenwithapillow/rolledblankettosupportthe
abdomen so that the Patch remains centered over the uterus.
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
Electrode ‘detached’ or
has bad contact with skin -
electrode not able to
function properly
3•Checkallelectrodesandensuregoodskincontact/adhesion.
•Considerre-positionPatchorelectrodetoavoidanyskinanomalies.Restartthe
Novii system for monitoring.
HELP/TIP
a) The Interface will alert user with a visual message, but only when electrode is fully detached.
b) Check electrodes for adhesion after a shower, clinical procedure, ambulation or a position change.
c) Electrode(s) should not be placed over a skin 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"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
1
The patient is ambulating -
may cause increased muscle
noise and/or displaced Patch
•Returnpatienttobedand/orreducepatient’sactivity.
•Considerusingamaternitybelttosupportpannusduringambulationoruprightposition.
HELP/TIP
a) Allow 10-15 minutes of monitoring before starting ambulation.
b) The patient should not be encouraged to ambulate unless the FHR trace
is consistent and the signal indicator on the Novii Interface shows
3 green squares.
Signal
*A small number of patients will not be able to be monitored successfully with the Novii despite troubleshooting.
**During a FHR gap there is silence, and it is therefore advised to explain this to the patient and partners so they are aware and not distressed when there is no audio noise.
•WhiletheNoviidetectstheFHRcontinuouslyonmanypatients,somepatientswillrequiretroubleshootingtoreacquirethe
FHR signal.*
•InadequatePatch/electrodeplacementorincreasednoise(electricalinterference)maycausefrequentorpersistentFHR
gapping** and/or FHR artifact. Sources of noise may include electrophysiological noise from the patient or fetus and electrical
noise from the environment.

18
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
5
Center of lowest electrode is
not 2.4"/6 cm above the
symphysis pubis, or in optimal
location for individual
•Re-positionlowestelectrodeonexiblecable(electrode#5).
Pannus covering pubic bone;
lower electrode placement dif-
cult to estimate
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
6•Some trial and error with positioning of lowest electrode over pannus may be required to
achieve optimal fECG signal.
•Removelowestelectrodeandplaceitlowerorhigherontheabdomen.
•Alternativelyplaceelectrodejustbelowthepointwherethesurfacecurves
back on itself ensuring that the electrode is not folded.
HELP/TIP
a) 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.
POSSIBLE CAUSE/PROBLEM ACTION & SOLUTION
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
4
Poor skin prep - dead skin
reduces transmission of
fECG signal
•Re-exfoliateskinunder‘bad’electrode.(Seebottomofpg.12.)
•Restartthemonitoringsessioniflocationof‘bad’electrodenotknown.
•DoesaparticularPodconsistentlydisplayaXon same electrode?
HELP/TIP
a) 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, then re-try Pod.
Replace Pod if needed.
•CheckInterfaceforhelpmessages:
 •“PatientOutofRange”–HaspatientambulatedoutofrangeorsubmergedPodunderwater?Hasamobile
phone been placed on or near Pod?
 •“CheckElectrodes”–Areallelectrodesadheredwelltopatient’sskin?Hasanelectrodebeendamaged?
Is Pod connected securely to Patch, ensuring good Pod pin connection? Try removing and replacing Pod,
or swap Pods.
•HasInterfaceturnedo?Checkpowersupplyconnection.
HELP/TIP
a) If Interface has lost power Bluetooth pairing with Pod is lost.
Remove Pod from Patch, place in charging bay and start new monitoring session when power is returned.
b) Interface does not have a battery back-up.
•IstheInterfaceStart-ScreendisplayedinsteadoftheMonitoringScreen?
HELP/TIP
Pod has switched o
– remove Pod from Patch and place in charging bay. Start new monitoring session with other Pod.
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
All Novii signals are lost. Blue-
tooth communication or cable/
power connection problem
All Novii
Signals Lost
•Areallcablesandconnectionssecure?ConsiderreturningthePodtotheInterfaceand
completing a Novii Test.

19
Reassurance
During loss of the FHR or during suspected FHR artifact, if reassurance is required, plug
an US Transducer into the fetal monitor and hold on the patient’s abdomen to try to get
the FHR from a second source.
The FHR from Novii and US Transducer will be simultaneously printed on the trace,
as if you were monitoring Twins. However, the Novii FHR will appear slightly behind the
US FHR due to the Novii 10 second delay.
Caution: FHR Oset may be enabled on the fetal monitor.
Caution: Novii FHR, Novii MHR and Novii UA are delayed by 10 seconds. See page 22
for Novii timing explanation.
Using a US Transducer to ‘ll’ in FHR gaps should only be done for short periods.
If FHR gaps from Novii continue after trying the trouble shooting suggestions,
consider 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 identiable 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 artifact.
•UsethesametroubleshootingadvicelistedpreviouslytotrytoincreasethefECGsignalqualityandreducethenoise.
•UsetheUltrasound(US)transducerforFHRconrmation.
•FHRartifactismorelikelytobeseenduringambulationandpositionchangeswhenelectrophysiologicalnoiseincreases.
•IfFHRartifactisrecurrentandunresolvable,adierentmonitoringmodemaybenecessary.
•ContinuouslydisplayingtheNoviiMHRonthetraceimprovesartifactidenticationincasesofFHR/MHRconfusion.
Examples of FHR artifact from Novii, recorded at 3cm/min

20
UA Troubleshooting
3
5
1
2
4
Novii UA – Essential Information
•Noviimonitorsuterine(EMG)activityontwochannels,using3electrodes.Electrode#3is
most important for UA monitoring. Quality will be aected if detached or has bad skin prep
at start, or if Patch is not optimally positioned over uterus.
•TheinterpretationofNoviiUAissimilartointerpretationofaTOCOtracing,sodoesnot
provide a measurable contraction strength or measurable uterine baseline tone.
•NoviiUAdurationmaybesomewhatdierentfromTOCO/IUPC.
Note: Patient perception, palpation, TOCO, IUPC, and Novii may produce 5 dierent measurements of duration for the same contraction.
•Noviidataisdelayedby10seconds,sotakethisintoconsiderationifusingNoviiUAto
coach the patient to push.
•AnyassessmentofNoviiUAshouldbeveriedthroughpalpation,aswithother
monitoring modalities.
High UA (False Positives)
•Electrical(EMG)signalsfromothermusclesinthebodyduringpatientmovement
can produce a false contraction on the trace.
•ExcessmovementorpressingonthePatch(electrodes)canproducefalseUA.
•After20secondsofpatientmovementtheUAtracewillbecome‘thicker’.
Use caution in interpreting a ‘thickened’ UA trace. See page 13.
•Askpatienttoreturntothebedifambulationisthecauseoffalsepositives.
HELP/TIP
PatientmovementmayalsocausethePatchtoshiftbackandforthacrosstheuterus,causingdeectionsand
the appearance of excessive UA. Palpate to conrm.
•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 assessment).
•Solution:SelectthelowUAsettingfromtheNoviiInterfacetoremovethesesmallfalse
positive contractions (Note: Novii UA spike which occurs on trace every 5 minutes will be
at 50% height when low UA setting is enabled. See page 13.)
HELP/TIP
Low UA setting will continue for 60 minutes before defaulting back to high UA
setting, which is the default mode. The user can change the mode at anytime as indicated.
SKIN PREPARATION GOOD
WAIT/REPEAT SKIN PREP
REPEAT SKIN PREP
(ONLY ONCE)
2.4"/6cm
1"/2-3cm
1"/2-3cm
FHR
MHR
UA
1
The patient is ambulating or
the fetus is active
Signal
Battery
UA
MHR
MHR/FHR are coincident
2
UA
UA
Low
UA
UA High
UA High
8 9 10 11 18171615141312
UA Low
Data (minutes)
UA Sensitivity Modes High/Low UA Sensitivity Explained
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 artifact from fetal/maternal movement and unsynchronized
myometrial activity.
POSSIBLE CAUSE/PROBLEM ACTION & SOLUTION
The patient is in early (latent)
labor or induction