Gaumard S552.250 User Manual

NOELLE® S552.250

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 17.7.1

©2017 Gaumard Scientific

All Rights Reserved

www.gaumard.com

Contents

End User License Agreement vi

1. Introduction 1

1.1 Specifications 1

NOELLE 1

1.2 Care and Maintenance 1

General 1
Operating Conditions 2
Storage Conditions 2
Procedures 2
Cleaning 2
Birth Canal Maintenance 3

NOELLE S552.250 | User Guide

2. Getting Started 4

2.1 Overview 4

Appearance 4
Simulator 4
Options 4

2.2 Terminology 4

Facilitator 4
Provider 4

2.3 Birthing Package 5

Check List 5

3. Equipment Setup 6

3.1 Overview 6

Fetal Heart Rate Speaker 6
Power Supply 6
OMNI® 2 Connection Setup 6

4. Using OMNI® 2 9

4.1 Main Screen 9

4.2 Perinatal Parameters 9

ii | Table of Contents

NOELLE S552.250 | User Guide

4.3 Labor Page 11

Actions 11
Feedback Graphics 12
Dystocia Menu 12

5. Working with NOELLE 14

5.1 Obstetrics 14

Automatic Birthing Mechanism and the OMNI® 2 14
Leopold Maneuvers 14
Optional Palpation Abdominal Cover 15
Dilating Cervix 16
Normal Labor and Delivery 16
Vacuum-Assisted Delivery 22
Shoulder Dystocia 23
Optional Cesarean Delivery 24
Prolapse of the Umbilical Cord 24
Placenta Previa 25
Breech Birth 25
Placenta Delivery 26
Episiotomy Repair 27

6. Virtual Monitor Setup (Optional) 28

7. OMNI® Link Setup 31

8. Appendix 33

8.1 Consumables and Replacements 33

Selected Parts List 33

8.2 Troubleshooting 34

Communication/Power Issues 34
Labor Motor 34

9. Warranty 35

9.1 Exclusive One-Year Limited Warranty 35

10. Contact Gaumard 36

10.1 Contacting Technical Support 36

10.2 General Information 36

Table of Contents | iii

NOELLE S552.250 | User Guide

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 OMNI 2 (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.

iv | End User License Agreement

NOELLE® S552.250 | User Guide

1. Introduction

1.1 Specifications

NOELLE

·  Noelle Weight: 18.7 lbs (8.48 kg)

·  Noelle Length: 33 in (83.82 cm)

·  Power Supply:

›  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)

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

Introduction | 1

Operating Conditions

  · The simulator will only power on when connected to the 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 de-

grees 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.

NOELLE S552.250 | User Guide

Procedures

·  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.

·  Remove all traces of any lubricant.

·  Do not clean with harsh abrasives.

·  Do not use povidone iodine on the simulator.

·  Dry thoroughly.

·  The simulator is “splash-proof” but not water-proof. Do not submerge

or allow water to enter the interior of the simulator.

2 | Introduction

NOELLE S552.250 | User Guide

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 mild solution of soap and

water. After cleaning, dust with talcum powder.

·  Store the spare birth canal in a cool, dry location.

·  Always lubricate the birth canal with silicone oil lubricant prior to

delivery.

  · Do not store the fetus inside the abdomen.

Introduction | 3

2. Getting Started

2.1 Overview

The NOELLE S552.250 teaching system permits students to appreciate

the complete birthing experience from the onset of labor, to delivery, and

treatment of the mother.

Appearance

  · Light skin tone is the standard simulator color; medium or dark is avail-

able at no extra cost.

Simulator

NOELLE S552.250 | User Guide

  · Delivering mechanism

  · Manage vertex, breech, dystocia, and instrument assisted deliveries

  · Soft and flexible birth canal

  · Multiple placenta positions

  · Practice postpartum suturing on vulval inserts

  · Practice Leopold Maneuvers

Options

  · C-section abdominal cover

  · Palpation abdominal cover

2.2 Terminology

Facilitator

The person conducting the simulation; an instructor or lab sta member.

Provider

A person participating in the simulation as a healthcare provider.

4 | Getting Started

NOELLE S552.250 | User Guide

2.3 Birthing Package

Check List

  · Abdomen cover with speaker attached

  · Articulating birthing fetus

  · Automatic birthing mechanism (installed)

  · Birthing fetus face skin

  · Birth canal (installed)

  · Inflatable cushion for Leopold Maneuvers

  · OMNI ® 2 Tablet (tablet, charger, USB cable, Quick Start Guide)

  · Power supply

  · One Silicone lubricant

  · Talcum powder

  · Two mechanical adaptors

  · Two episiotomy suture trainer

  · One placenta with fragments

  · Two umbilical cords

  · One umbilicus

  · One Umbilical clamp

  · User Guide

Getting Started | 5

3. Equipment Setup

3.1 Overview

NOELLE is shipped assembled. The birthing fetus is fully assembled.

Perform the following steps as part of the first install process.

Fetal Heart Rate Speaker

Connect the speaker cable, exiting

NOELLE’s abdominal cover, to the

right side of the birthing mecha-

nism.

NOELLE S552.250 | User Guide

Power Supply

Connect the power supply to the

power input located on NOELLE’s

right side, and then connect the

power supply to the wall outlet.

Always operate NOELLE with the power supply connected.

OMNI® 2 Connection Setup

OMNI® 2 controls Noelle’s responses with the touch of a button.

The tablet operates Noelle wirelessly.

Noelle can be operated using a wired connection. Please refer to the

OMNI 2 user guide to set up a wired connection.

6 | Equipment Setup

NOELLE S552.250 | User Guide

Follow the steps below to connect to OMNI® 2:

1. Connect the power supply to

Noelle

2. Turn on OMNI® 2 by pressing and holding the ON button on the right

side of the tablet.

3. Select “Allow” to turn on

Bluetooth for the tablet.

4. A startup screen is shown

while OMNI® 2 is detecting

the simulator features.

Equipment Setup | 7

5. Follow the on-screen tuto-

rial for a brief overview of

OMNI® 2’s features.

6. Move onto the next steps

in the tutorial by selecting

“GOT IT”.

7. Exit the tutorial at any time

by selecting “HOME”.

Complete the tutorial

one time to avoid it from

appearing at start-up in

the future.

NOELLE S552.250 | User Guide

After the tutorial, OMNI® 2 will

proceed automatically to the

Favorites Page and establish a

connection to NOELLE.

WARNING: Do not connect

NOELLE or OMNI® 2 to a

computer. LAN network

or unathorized diagnostic

equipment. Doing so will

cause serious damage to the

equipment.

8 | Equipment Setup

4. Using OMNI® 2

4.1 Main Screen

OMNI® 2 opens at the Favorites

Page upon start up.

NOELLE S552.250 | User Guide

4.2 Perinatal Parameters

Change the fetal vital signs in

the Vitals Page. Observe the

changes on the optional Virtual

Monitor. Find all the parameters

in the Vitals Page.

For more information on how to use

the Virtual Monitor, please refer to

the OMNI® 2 User Guide.

Using OMNI® 2 | 9