Gaumard NOELLE S554.100 User manual

NOELLE®S554.100
Maternal Birthing Simulator
User Guide
NOELLE is an interactive educational system developed to assist a certified
instructor. It is not a substitute for a comprehensive understanding of
the subject matter and not intended for clinical decision making.
User Guide 22.5.1
©2022 Gaumard Scientific
All Rights Reserved
www.gaumard.com

NOELLE® S554.100 | User Manual
Table of Contents | iii
Contents
End User License Agreement viii
1. Introduction 1
1.1 Specifications 1
NOELLE 1
Newborn 1
1.2 Care and Maintenance 2
General 2
IV Arm 2
Operating Conditions 3
Storage Conditions 3
Procedures 3
Cleaning 3
Birth Canal Maintenance 4
Post-Partum Hemorrhage Check List and Warnings
4
Labor 4
2. Getting Started 5
2.1 Overview 5
Highlights 5
Noelle Simulator 5
Newborn 5
Simulated Vital Signs Monitor 6
2.2 Terminology 6
UNI 6
Facilitator 6
Provider 6
Palette Item 6
Profile 6
Scenario 7
Scenario Item 7
2.3 Birthing Package 7
Check List 7
3. Equipment Setup 8
3.1 Overview 8

NOELLE S554.100 | User Manual
iv | NOELLE S554.100
Leg Assembly 8
Power Supply 8
Newborn Power Supply 9
3.2 Control Computer 9
Communications Module 9
3.3 Virtual Monitor 10
Virtual Monitor Wireless Connectivity 10
Gaumard Monitors 11
MICRO + (Optional) 11
4. Working with UNI 12
4.1 Initializing the Simulator 12
4.2 UNI Interface 13
Connection Status 13
Back-Up Battery Indicator 13
Power/Stand By 14
4.3 Quick Launch 14
Clinical Condition 14
Selecting the Scenario 15
Favorites 17
4.4 Status/Details Controls 17
Changing Vital Signs 18
Applying Changes 19
Creating Palette Items 20
4.5 Model (Newborn) 22
Physiological Modeling State 22
Cyanosis Levels 22
5. Working with NOELLE 24
5.1 Cephalic 24
Seizures 24
5.2 Airway 24
Nasal and Oral Intubation 24
5.3 Artificial Respirations 25
Ventilation 25
Calibration 25

NOELLE® S554.100 | User Manual
Table of Contents | v
5.4 Circulation 27
Compression 27
Calibration 27
Bilateral Pulses 28
Injection Site 29
Bilateral IV Arm 29
Instructions for Use 30
5.5 Obstetrics 31
Normal Labor and Delivery 31
Placenta Delivery 37
Vacuum-Assisted Delivery 38
Leopold Maneuver 39
Optional Leopold Maneuvers 40
Dilating Cervix 41
Shoulder Dystocia 42
Cesarean Delivery 43
Optional Cesarean Delivery 44
Prolapse of the Umbilical Cord 44
Placenta Previa 44
Breech Birth 45
5.6 Postpartum Activity 46
Filling the PPH Reservoir 46
Fundal Massage and Postpartum Hemorrhage 47
Cleaning the PPH System 48
Episiotomy Repair 49
6. Working with Newborn 51
6.1 Airway 51
6.2 Breathing 51
6.3 Cardiac 52
6.4 Circulation 52
6.5 Cephalic 52
6.6 Systemic 53
6.7 Other 53
Vital Signs Monitor 53

NOELLE S554.100 | User Manual
End User License Agreement | vii
7.Other 53
53
7.1 Selected Parts List
7.2 Replacing the Veins 54
Replacement Instructions 54
7.3 Troubleshooting 56
8.Wireless Network 60
8.1 For Windows 8 and 10 60
Configure the Vital Signs Broadcast 61
9.Warranty 63
9.1 Exclusive One-Year Limited Warranty 63
9.2 Extended Warranty 63
10.Contact Gaumard 64
64
10.1 Contacting Technical Support
10.2 General Information 64

NOELLE S554.100 | User Manual
viii | End User License Agreement
This is a legal agreement between you, the end user, and Gaumard® scientific company, inc. (“Gaumard”). This software is protected by copyright
laws and remains the sole property of Gaumard. By installing the UNI™ (the “software”) media, you agree to be bound by the terms of this agreement.
If you do not agree to the terms of this agreement, promptly return the uninstalled media and accompanying items to Gaumard at the address
indicated below.
1. Grant of License: Gaumard hereby grants to you (an individual or institution) the right to install and activate the software on one computer for use
with one interactive patient simulator system. The software may also be installed on any number of other computers at the same institution so that
students may access the learning resources. One copy of the software may be made for backup purposes. You may not network this software, or
allow multiple users unless you purchased a multi-user workstation license. Sharing this software with other individuals or allowing other individuals
to view the contents of this software is in violation of this license.
2. Copyright: The software is owned by Gaumard and protected by United States copyright laws and international treaty provisions. Therefore, you
must treat this software like any other copyrighted material. You may not make this software or copies thereof available in any manner or form or
use, copy or transfer the software, in whole or in part, except as provided herein.
3. Other Restrictions: You may not rent or lease this software to any other party. You may not alter, merge, modify, adapt, reverse engineer, decompile
or disassemble the software, or disclose the contents of this software to any other party.
4. Electronic Transmission of Software: If you received the software by electronic transmission or by internet delivery, by installation of the software,
you acknowledge that you have read and understand this license agreement and agree to be bound by its terms and conditions.
5. Term of Agreement: The term of this agreement and the license granted to you pursuant hereto shall commence upon installation of this software.
This agreement and the license granted herein may otherwise be terminated by Gaumard in the event that you are in breach of any provision of this
agreement. In the event of termination, you agree to immediately return this software, accompanying items, and any copies thereof to Gaumard.
6. Limited Warranty:
(A) The cd-rom media (the “media”) which contains this software is warranted, for a period of 30 days from the date of purchase, to be free from
defects in material and workmanship. Electronic transmission is warranted to be free from defects at the moment of transmission. Your sole and
exclusive remedy, and Gaumard’s sole liability, is to replace the defective media or to repeat the electronic transmission provided that you notify
Gaumard in writing of such defect or defective transmission and return the defective media, if any, during the 30-day warranty period.
(B) Except and to the extent expressly provided in paragraph (a), the software and accompanying written materials are provided on an “as is” basis,
without any warranties of any kind, including, but not limited to, any implied warranties of merchantability or fitness for any particular purpose. No oral
or written information or advice given by Gaumard, its dealers, distributors, agents or employees shall create a warranty or in any way increase the
scope of this warranty, and you may not rely on any such information or advice. Gaumard does not warrant, guarantee, or make any representations
regarding the use or the results of use, of the software or written materials in terms of correctness, accuracy, reliability, currentness, or otherwise, and
the entire risk as to the results and performance of the software is assumed by you. If the software or written materials are defective, you and not
Gaumard or its dealers, distributors, agents, or employees, assume the entire cost of all necessary servicing, repair or correction other than expressly
described above.
(C) Neither Gaumard nor anyone else who has been involved in the creation, production or delivery of this product shall be liable for any direct,
indirect, consequential or incidental damages (including damages for loss of business profits, business interruption, loss of business information,
and the like) arising out of the use or inability to use such product or related to this agreement even if Gaumard has been advised of the possibility
of such damages. Gaumard shall not be liable to you for any indirect, special, incidental, or consequential damages or lost profits arising out of or
related to this agreement or your use of the software and/or the related documentation, even if Gaumard has been advised of the possibility of such
damages. In no event shall Gaumard’s liability here under, if any, exceed the purchase price paid by you for the software.
All rights not expressly granted in this license agreement are reserved by Gaumard.
ACKNOWLEDGMENT
By installation of this software, you acknowledge that you have read and understand the foregoing and that you agree to be bound by its terms
and conditions. You also agree that this agreement is the complete and exclusive statement of agreement between the parties and supersedes all
proposed or prior agreements, oral or written, and any other communications between the parties relating to the license described herein.
End User License Agreement

NOELLE® S554.100 | User Manual
Introduction | 1
1. Introduction
1.1 Specifications
NOELLE
· Weight:
› NOELLE: 54 lbs (24.5 kg) with abdominal cover
· Length: 5’8” inches (172 cm)
· Wired connectivity: Gaumard USB Communication Module (RJ45)
· Battery Charger:
› Power input: 100-240 VAC, 50/60 Hz, 500 ma/ 50 VA
› Power output: 12 VDC/ 2 A/ 24VA
· Weight:
› Birthing baby: 2 lbs (0.9 kg)
· Length:
› Birthing baby: 16.5” (41.91 cm)
Newborn
• Weight: 4.6 lbs (2.09 kg)
• Height: 22” (55.88 cm)

NOELLE S554.100 | User Manual
2 | Introduction
1.2 Care and Maintenance
WARNING: Damage caused by misuse is not covered by your warranty.
It is critical to understand and comply with the following guidelines.
WARNING: The lubricants and other accessories provided are for use
with the accompanying patient simulator only. The lubricants and oth-
er accessories are not suitable for human use or medical treatment/
diagnosis and should never be used for such purposes.
General
· Ball point pens, ink, and markers permanently stain the skin.
· Do not wrap this or any other Gaumard product in newsprint.
· Marks made with ballpoint pens, ink or marker cannot be removed.
· Replacement parts are available from Gaumard Scientific or from your
Distributor
IV Arm
WARNING: Vein tubing contains latex which may cause allergic reac-
tions. Users allergic or sensitive to latex should avoid contact. Dis-
continue use of this product and seek medical attention if an allergic
reaction occurs.
· Only use liquid colorant for simulated blood. Simulated blood contain-
ing sugar or any additive may cause blockage and/or interruption of
the vasculature system.
· The use of needles larger than 22 gauge will reduce the lifetime
of the lower arms’ skin and veins.
· Always purge with clean water and then drain the vein reservoirs at the
end of the simulation session. Doing so will retard the formation of
mold and prevent clogging of the system.
· We recommend flushing veins with 70:30 solution of clean water to
isopropyl alcohol (IPA) at least once per month to prolong the life of
the vasculature.
· When the arm skin and/or veins require replacement, refer to the
“Consumables” section of this guide. For more information regarding
the replacement of veins and other consumable items please contact
customer service.

NOELLE S554.100 | User Manual
Introduction | 3
Operating Conditions
· The simulator will only power on when connected to the AC power supply.
· Operating temperature: 50°-95° F (10°-35° C)
· Humidity: 5%-95% (non-condensing)
WARNING: To avoid damage to the simulator, please store and ship it
in the clear poly bag provided.
Storage Conditions
· Store Simulator in a cool, dry place. Extended storage above 85 degrees
Fahrenheit (29 Celsius) will cause the simulator to soften and slowly warp
· Humidity: 40%-60% (non-condensing)
· Do not stack or store heavy materials on top of the carton.
Procedures
· Do not attempt to intubate without lubricating the airway adjunct with
silicone oil lubricant. Failure to lubricate the device will make intubation very
difficult and is likely to result in damage to the simulator.
· When simulating drug administration via endotracheal tube, providers must
use an empty syringe. Passing liquids into the trachea or esophagus may
cause internal damage.
· Mouth to mouth resuscitation without a barrier device is not recommended,
as it will contaminate the airway.
· Treat the simulator with the same precautions that would be used with a real
patient.
· Always keep clear of the birthing mechanism while the system is on.
· Never operate the birthing mechanism without the tummy cover in place.
Cleaning
· The simulator should be cleaned with a cloth dampened with diluted liquid
dish washing soap. Then, dry thoroughly.
· Remove all traces of any lubricant.
· Do not clean with harsh abrasives.
· Do not use povidone iodine on the simulator.
· Do not use “GOO GONE” as the citric acid in the formula will cause pitting of
the various materials.
· The simulator is “splash-proof” but not water-proof. Do not submerge or
allow water to enter the interior of the simulator.

NOELLE S554.100 | User Manual
4 | Getting Started
Birth Canal Maintenance
·Ball point pens, ink and markers permanently stain the birth canal insert.
· Do not wrap this or any other Gaumard product in newsprint.
· The birth canal insert can be cleaned with a small amount of silicone
lubricant. After cleaning, dust with baby powder.
· Store the spare birth canal in a cool, dry location.
· Always lubricate the birth canal with silicone oil lubricant prior to
delivery
WARNING: Do not store fetus in abdomen. Damage results to the birth
canal and fetal head.
Post-Partum Hemorrhage Check List and Warnings
· Only use Gaumard’s simulated blood. Any other simulated blood
containing sugar or any additive may cause blockage and/or interrup-
tion of the vasculature system.
· Always ensure that the distal end of the uterus is inserted through the
cervical opening of the birth canal until the cervix closes around the
built in recess. Failure to do so could result in liquid accumulating in the
pelvic cavity and damage to the birthing mechanism.
· Always position the simulator so post- partum hemorrhage fluid flows
away from the birth canal and the simulator itself.
· Do not allow post-partum hemorrhage fluid to puddle beneath the
simulator or reach the lower back.
· At the end of every simulation, always flush the system with distilled
water to prevent clogging. At the end of every simulation, always flush
the system with distilled water to prevent clogging.
· To prevent staining or molding, always clean NOELLE using diluted
soap and water. Remove the birth canal and clean thoroughly.
Labor
· Always lubricate the fetus and the birth canal before every delivery.
Failure to do so will result in damage to the birthing mechanism and
the birth canal.
· Do not pull the baby upward in contrast to the birthing mechanism’s
linear trajectory. Doing so can bend the motor arm and cause damage
to the birthing mechanism.

NOELLE S554.100 | User Manual
Getting Started | 5
2. Getting Started
2.1 Overview
The NOELLE S554.100 is a comprehensive package of simulator technol-
ogy, scenario-based training, and performance measurement and debrief-
ing tools designed to build competencies needed to help manage OB
emergencies.
Highlights
• Prepare for OB emergencies; evaluate and report on training and
clinical outcomes
• Full size NOELLE maternal and neonatal birthing simulator with ec-
lampsia and hemorrhage capabilities
• Mobility allows training to be in L+D and postpartum units
• Build team and technical competencies
• Maternal vital signs monitor
• Fetal heart tones and neonatal vital signs monitor
• Set up and run OB emergency simulations for shoulder dystocia,
postpartum hemorrhage, eclampsia, umbilical cord prolapse, breech
vaginal delivery, operative vaginal delivery, neonatal resuscitation
Noelle Simulator
• IV arms for meds/fluids
• Intubatable airway with chest rise
• Removable stomach cover
• Chest compressions and ventilations are measured and logged
• Programmable eclampsia
• Advanced birthing mechanism
• Programmable postpartum hemorrhage
• Birthing fetus with placenta and umbilical cords
Newborn
• Full term intubatable newborn with cyanosis and umbilical pulse
• Chest compressions and ventilations are measured and logged
• Realistic heart and lung sounds
• Realistic crying

NOELLE S554.100 | User Manual
6 | Getting Started
Simulated Vital Signs Monitor
• Single large 23 inch touchscreen monitor with desktop controller and
wireless communication to laptop
• Display up to 8 numeric values including HR, ABP, RR, CO2, SpO2,
temperature, NIBP, and time
• Select up to 5 dynamic waveforms including ECG II, ABP, respiration,
CO2, and pulse oximetry
• Fetal Heart Rate monitor
2.2 Terminology
UNI
The Gaumard User Interface software application, used to control the
simulator and evaluate care providers.
Facilitator
The person conducting the simulation; an instructor or lab staff member.
Provider
A person participating in the simulation as a healthcare provider.
Palette Item
Any full or partial set of physiological parameters saved together under a
single name.
Profile
A unique configuration, including custom palettes, scenarios, and options.
Each profile acts as a separate program whereby changes made to one
profile have no effect on the others.

NOELLE S554.100 | User Manual
Overview | 7
Scenario
A saved sequence of physiological states, which flow like a “play list.”
Scenarios provide a level of automation that unburdens the facilitator and
allows standardized presentation of symptoms.
Scenario Item
A Palette Item that is part of a scenario. Scenario Items may also repre-
sent a fixed delay period (“Wait”) or a pause (“Wait Indefinitely”).
2.3 Birthing Package
Check List
• 48 hour postpartum uterine assembly
• Abdomen cover
• Articulating birthing fetus
• Automatic birthing mechanism
• Carrying bag for neonate
• Inflatable cushion for Leopold Maneuvers
• NOELLE head and torso assembly
• Postpartum hemorrhage kit
• Power supply
• Replacement Veins Set
• Two Silicone lubricant
• Talcum powder
• Two vulva insert for episiotomy repair
• One birth canal
• One placenta with fragments
• Two umbilical cords
• One umbilical cord stud
• Two Umbilical clamps
• User Guide

NOELLE S554.100 | User Manual
8 | Equipment Setup
3. Equipment Setup
3.1 Overview
NOELLE is shipped partially assembled. The birthing fetus and neonate
are fully assembled. Perform the following steps as part of the first install
process.
Leg Assembly
1. Remove the fixed bolts from
the knee joints using the hex-
agonal wrench provided.
2. Position the lower legs and
re-insert the knee joint bolt.
Then, secure the knee bolts
without over tightening.
Power Supply
Connect the power supply to the
wall outlet, and then connect to the
power input located on NOELLE’s
right side.
Always operate NOELLE with
the power supply connected.
NOELLE is equipped with an internal backup battery to maintain func-
tionality in the event the power adapter is unplugged, or the simulator is
requires transportation from one room to another.
WARNING: Do not store the simulator with a discharged battery.
Re-charge the system at least once every 3 months if the simulator
is not being used; otherwise permanent loss of capacity will occur.

NOELLE S554.100 | User Manual
Equipment Setup | 9
Newborn Power Supply
Connect the power adapter labeled Newborn to the power input located
on Newborn’s right side.
Always operate Newborn with the power supply connected.
3.2 Control Computer
The laptop computer is the simu-
lator’s control center. Startup and
control commands are sent from
the Gaumard control software (UNI)
to the simulator using the wired
communication module shown in
the next section.
Review all manufacturer warnings and procedural information included
with the laptop’s documentation before continuing.
Communications Module
Follow the steps below to connect the communication module to the
simulator and the laptop computer.
UNI controls only one simulator at a time. To switch between NOELLE
and Newborn, first exit the UNI software and reconnect the communi-
cations cable to the simulator you wish to control.
WARNING: Do not connect the simulator to Ethernet cards, LAN
networks or unauthorized diagnostic equipment. Doing so may cause
damage to the system.
1. Connect the communication
cable to the USB communica-
tion module.

NOELLE S554.100 | User Manual
2. Connect the USB communica-
tion module to an available USB
port and power on the laptop
computer.
3. Connect the communication
cable to the communications
port located on the simulator’s
right side.
3.3 Virtual Monitor
The mobile virtual monitor system works
with UNI to display the vital signs of NO-
ELLE, birthing baby and Newborn.
Refer to the manufacturer’s documen-
tation included with the virtual monitor
system components for important safety,
installation and start-up information be-
fore turning on the computer for the first
time.
Please find assembly instructions in
booklet included.
Virtual Monitor Wireless Connectivity
The control laptop and the virtual mon-
itor computer automatically establish
a wireless connection at startup. The
wireless connection allows the UNI con-
trol software to send vital signs infor-
mation to the Gaumard Monitors soft-
ware. To verify the wireless connection,
click on the wireless icon located on the
task tray. To troubleshoot connection
issues, please refer to section 10.
10 | Equipment Setup

NOELLE S554.100 | User Manual
Equipment Setup | 11
Gaumard Monitors
After the wireless connection is estab-
lished, double click or tap the Gaumard
Monitors icon on the virtual monitor’s
home screen.
The Gaumard Monitors software
is now ready to receive vital signs
information generated by the UNI
control software.
MICRO + (Optional)
The Micro+ system is an all-in-one
debriefing and simulator control
solution for facilitators working in
a lab or mobile environment. The
system combines UNI and powerful
audio/video recording software in
one control laptop.

Initializing the Simulator with UNI & OMNI Link
Noelle also has the capability to connect to its USB tablet/PC via a
Bluetooth connection provided by an OMNI Link Wireless Adapter Kit.
It is strongly recommended to connect to the simulator using the
OMNI Link for optimal audio quality when using the simulator's
streaming audio features.
The OMNI Link Wireless Adapter Kit began shipping as standard with
Noelle serial number M2107588 and above. Simulators with serial
numbers lower than M2107588 will need to have the RJ45 port
modified.
For simulators without the OMNI Link Wireless Adapter Kit, refer to
the instructions above on connecting to Noelle using the USB RF
module.
To initialize Noelle using the OMNI Link:
1. Remove the OMNI Link from its package.
3.Press the power button on the OMNI Link to enable Bluetooth.
NOTE: It will flash green when ready.
2. Plug the OMNI Link into the RJ45
port on the simulator's side.
NOELLE S554.100 | User Manual
11a | Equipment Setup

NOELLE S554.100 | User Manual
Turning on the Simulator with OMNI Link
1. Disconnect the RF module
from the UNI tablet/PC.
2. Double click the UNI icon and
select the correct simulator
profile. Ensure you are using UNI
version 2.46.2 or newer.
3. Upon software startup, a warning message will
appear stating that the RF Module was not found.
Click OK.
NOTE: This is the warning message that appears
for the first time use of the OMNI Link with the
simulator.
Equipment Setup | 11b