Monica Healthcare Novii User manual

Getting Started Guide:
The box should contain the following items, check that everything is present.
x1 Monica Novii™ Interface Device
x3 Monica Novii™ PODs
x1 Power Supply for Interface Device
x3 Cables to connect interface to fetal monitor*
x2 Monica Novii™ Patches
x1 Getting Started Guide; x1 Troubleshooting Guide
x1 CD containing IFU & other support/training materials
x1 3M Red Dot 2236 Skin Prep Tape
*FECG, TOCO and MECG input cables for Corometrics 259cx maternal/fetal monitor are supplied. Each cable will be clearly marked.
The monitor must be equipped with 1442AAO GEHC Y-adapter cable.
One of the x3 PODs should remain in its box and the box placed in a secure location that does not see extremes in temperature or
humidity, as a backup/replacement device for POD loss, damage or breakdown.
Connecting the Cables and Power Supply
For more information please refer to the User Manual on the CD, section 5.
1. The output sockets for the three cables speciic to the Corometrics 259cx Series fetal
monitor, are clearly labelled on the back of the Interface.
2. Connect the three cables, which are clearly marked, to the correct Interface socket.
3. The UA cable connects directly to the TOCO (white) port of the Coro 259cx Series
monitor, but you will need the ‘Y’ adapter to connect both the FHR (black) and MHR
(green) cables to the monitor.
4. The DC power input socket is on the rear of the Interface to the left of UA/TOCO
socket. There is no on/o switch.
5. Connect the power supply cord to the Interface and then plug into an AC power outlet
to power on.
6. The irst screen to be displayed is the SELECT LANGUAGE screen (1).
7. Press the forward arrow keys to save selection and restart Interface.
8. The Novii Registration Screen will now be displayed (2).
The Novii™Interface and PODs cannot be used until they have been registered
1. From the registration screen (2) make a note of the access code shown in red.
2. Go to www.monicahealthcare.com/support.
3. Log on or Register for a Monica account.
4. Once you have logged in, select ‘Register Novii Device’ from the menu and follow the on screen instructions.
5. On completion of the registration process you will be given a pass code to enter on the Interface display.
6. The pass code when entered (the back arrow can be used to delete the last number(s) entered if a mistake has been made)
will unlock.
7. Any un-registered POD placed in the Interface charging bay will bring up the Registration display and the process will need to
be repeated to unlock the POD(s).
8. To avoid any confusion register one POD at a time, by placing the POD in the left hand charging bay only.
(1) Press forward arrow key (2) To unlock the device, note the red access code
and go to www.monicahealthcare.com/support
SELECT LANGUAGE ENGLISH REGISTRATION REQUIRED
To obtain PASS CODE, visit
www.monicahealthcare.com/support
and enter access code below:
(case-sensitive)
TA002050X05G
ENTER PASS CODE:
7433
1 2 3
4 5 6
7 8 9
0

Patch Placement & Skin Prep
lRemove protector from back of Patch plastic clip.
lStick Patch down over umbilicus and follow picture instructions on Patch pouch. When umbilicus is displaced, see below.
Start/During Monitoring
lFollow instructions on Interface screen. Only select POD if battery status shown above POD is green.
lKeep patient rested for irst 1015 minutes in bed before ambulation.
lIf FHR gap: (1) Stop ambulation; (2) Place pillow behind patient’s back/head; (3) Re-position patient, turn to left or right side;
(4) Has Patch been displaced relative to the uterus? If yes, consider supporting abdomen with a pillow or maternity belt to ensure
Patch remains centered over uterus; and/or (5) reposition the lower electrode down or place on underside of pannus just after
turn; (6) ‘Fill’ gap for a short period with US transducer.
lIf UA is hypersensitive: Is there excessive fetal or maternal movement? Press UA High/Low button on Interface to reduce
sensitivity for 60 minutes.
Swap POD (low battery) or End Monitoring
lRemove POD from Patch, if time, clean with an approved cleaner, but must return to empty charging bay.
lTake other charged POD from charging bay and place in Patch clip.
lWhen done, keep Interface power on at all times with PODs docked to keep charged.
Caution
lNovii FHR/MHR/UA are synchronized but delayed 10 second with respect to US FHR and TOCO UA on trace. If Novii UA is
unplugged the Novii FHR is delayed 6 seconds with respect to US FHR and TOCO UA.
lThe Novii UA trace does not show patient pushing or UA baseline tone.
lAvoid placing electrode center over umbilicus, pronounced stretch marks, linea nigra & other skin defects.
lAfter removal of POD from Patch, clean if you can and return to charging bay; do not put it down anywhere else, the gold pins
may be damaged or you may lose it.
Displaced Uterus
In high BMI women the umbilicus can be displaced downwards with respect to the uterus, so the Patch clip should not be
positioned over the umbilicus. Two alternatives:
1. Position the Patch plastic clip on the midline on the center of the uterus i.e. midway between the fundus and symphysis pubis.
The lower electrode on the lexible tail should be placed on top of pannus, approximately 2.4/6 cm horizontally from the
symphysis pubis*.
2. Position the Patch plastic clip along the midline such that the edge of the top electrode, marked with the red arrow, is placed 4
to 5/10 to 13 cm (width of a hand), below the fundus. The lower electrode on the flexible tail should be placed on top of pannus,
approximately 2.4/6 cm horizontally from the symphysis pubis*.
Monica Novii Wireless Patch System Help Card
Before Monitoring
lCheck Patch expiration date & conirm the pouch has not been opened.
lWash abdomen to remove any cream/oil/gel from skin and dry.
lLocation of umbilicus. Is it at center of uterus? If yes, use aslandmark for Patch placement, If no, see ‘Displaced Umbilicus’ below.
*This can be difficult to estimate; if the FHR signal is poor, reposition this electrode lower down
on abdomen to maximize FHR signal and consider placing under pannus just below turn. Part Number; 107-PT-006-USrev2