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P80 SIMone Product Manual

P80 SIMone Product Manual
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P80 SIMone Product Manual

Product catalog summary
Overview
The SIMone™ birth simulator is an interactive tool designed for simulating birth processes, allowing users to practice decision-making and the use of instruments in operative vaginal delivery and childbirth complication management.
General Information
Operating instructions are crucial for safe and efficient use, highlighting the importance of adhering to safety regulations and recognizing hazard symbols.
Safety
The simulator's intended use, operator responsibilities, and safety procedures for transport and emergencies are outlined, including environmental protection and replacement parts.
Technical Data
Includes dimensions, connection values, operating conditions, and installation requirements, with a nameplate for identification and compliance.
Layout and Function
The simulator features a female abdomen torso and a mobile base with height adjustment, controlled via a PC with a touchscreen interface.
Transport, Packaging, Storage
Guidelines for safe transport and storage, including inspection and packaging symbols, to maintain simulator integrity.
Installation and Initial Start-up
Details on safe installation, space requirements, and connection procedures to ensure proper setup and operation.
Operation
Discusses operational safety, personal protective equipment, and simulator controls, including starting, scenario selection, and debriefing procedures.
Birth Scenarios
Includes scenarios like multipara, hyperactive labor, and complications such as fever and infections, each designed to simulate specific conditions.
Maintenance
Outlines maintenance schedules and tasks, including cleaning and fuse replacement, to ensure longevity and functionality.
Errors and Disposal
Provides guidance on troubleshooting errors and proper disposal of the simulator.
Accessories and Replacement Parts
Information on available accessories and replacement parts to support operation and maintenance.
Safety Precautions
Emphasizes keeping work areas clean, ensuring functional safety equipment, using emergency stops, and securing the simulator during transport.
Technical Specifications
Details dimensions, operating conditions, and electrical requirements.
Installation and Operation
Highlights installation location requirements, simulator functions, and scope of delivery.
Transport and Storage
Includes transport inspection, safety, and packaging disposal guidelines.
Specifications and Procedures
Covers transport and handling, packaging disposal, and storage conditions.
Installation and Initial Start-up
Safety requirements, electrical safety, and personal protective equipment guidelines.
Operation
Core safety requirements, personal protective equipment, and simulator starting procedures.
Device Operation
Allows adjustments and controls, including pausing, fast-forwarding, and changing views, with access to case histories and virtual diagnoses.
Simulation Application
Interactive features for displaying case histories, conducting diagnoses, and accessing intervention menus.
Intervention Menu
Details medicinal and operative interventions available during simulations.
Emergency Procedures
Instructions for emergency stops and safety measures before restarting.
Debriefing and Results
Post-simulation review through cardiotocograms, partograms, and 3D images.
Birth Scenarios
Guidance on recognizing and responding to different childbirth situations.
Maintenance and Shutdown
Post-use cleaning and shutdown instructions to prevent damage.
Emergency Tocolysis and Caesarean Section
Procedure for emergency tocolysis and caesarean section in cases of uterine tetany.
Contractile Dystocia
Management of inefficient contraction activity using oxytocin.
Intra-Uterine Asphyxia
Focuses on vaginal-operative delivery using forceps or vacuum extractor.
Fever and Infection Complications
Management of fever and infection complications during pregnancy.
Preeclampsia and HELLP Syndrome
Management of preeclampsia and HELLP syndrome, including emergency procedures.
Overdue Scenarios
Management of overdue pregnancies with or without labor induction.
Maintenance Procedures
Cleaning, interval maintenance, and fuse replacement guidelines.
Error Handling and Disposal
Instructions for error handling and proper disposal of components.
Accessories and Replacement Parts
List of available parts and accessories for maintenance and operation.
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Catalog excerpts

P80 SIMone Product Manual-1

SIMone™ BIRTH SIMULATOR OPERATING INSTRUCTIONS

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P80 SIMone Product Manual-2

© 2016 3B Scientific GmbH [email protected] This document and its parts are protected by copyright. Any use for purposes other than those legally authorized therefore requires the prior written consent of 3B Scientific GmbH. www.birthsimulation.com

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P80 SIMone Product Manual-3

Table of Contents I SIMone™

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SIMone™ › 1. OVERVIEW 1.1 Summary The SIMone™ birth simulator is used to simulate birth processes interactively. During a birth scenario, the user assesses the birth process, makes decisions and implements measures, and discusses them with a trainer at the end of the process. During a simulation, the participants practice – depending on the scenario – the correct use of the instruments used for an operative vaginal delivery and the management of complications during childbirth. 1.2 Overview of the birth simulator PC with touchscreen interface Torso of the female abdomen Mobile base with height...

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P80 SIMone Product Manual-5

› 2. GENERAL INFORMATION 2.1 Information on the operating instructions These operating instructions contain important information on the safe and efficient use of the simulator. They are an integral part of the simulator and must be kept in its immediate vicinity and accessible at all times for staff working on or with it. Staff must have carefully read and understood these operating instructions before beginning any work. A basic prerequisite for safe operation is compliance with all instructions concerning safety and use. In addition, the l ocal accident prevention regulations and general safety...

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P80 SIMone Product Manual-6

2.7 Definition of terms These operating instructions contain technical terms associated with obstetrics and birth assistance, explained as follows:

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P80 SIMone Product Manual-7

3bscientific.com General Information I SIMone'

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SIMone™ › 3. SAFETY This section provides an overview of all important safety aspects for optimum protection of staff as well as safe and trouble-free operation. Failure to follow the handling instructions set out in these operating instruction can result in significant hazards. The operator is also responsible for ensuring that the simulator is: • Always in perfect technical condition. • Maintained in accordance with the specified maintenance intervals. • egularly checked to ensure that all safety equipment is complete R and working properly. 3.1 Intended use The simulator is designed and constructed...

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P80 SIMone Product Manual-9

Teachers For the operation of the simulator, a person trained in obstetric and operation of the simulator is required. Students Students may work on the simulator only after training and in compliance with the safety instructions. Electrician Allowed to carry out all work on the electrical system of this simulator. With technical training, knowledge and experience and familiarity with the relevant standards and provisions, the electrician is qualified to carry out work on electrical systems properly, independently recognize potential hazards and prevent the occurrence of injury or damage to property...

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SIMone™ Moving components WARNING! Risk of injury from moving components! Moving parts can cause injury. To avoid this risk during operation: • Do not insert body parts or objects into the birth canal that are not used for the simulation of a determination of position or operative vaginal delivery. • Use only medical devices commonly used for childbirth. • Never operate the simulator with the cover/housing re moved. • Before opening the simulator, switch off the device at the main switch and secure it against being switched back on by pressing the emergency stop button and unplugging the power...

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P80 SIMone Product Manual-11

Main switch The main switch is also designed as an emergency stop button. Switching the main switch to the “0” position shuts off the power supply immediately, triggering an emergency stop. 3.7 Securing against restart WARNING! Risk of injury due to unauthorized restart! When working on individual assemblies or components, there is a risk of the power supply being switched on by an unauthorized person, causing injury to those in the danger zone. Therefore: • efore all work, use the following procedure to secure the B device against a restart: 1. Switch off the device at the main switch. 2. Press...

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SIMone™ 3.10 Procedure in the event of danger or accident If not already defined in the in-house accident prevention regulations, always ensure the following in the event of danger or accident: Preventive measures • Always be prepared for accident or fire. • eep first aid equipment (first aid kit, blankets etc.) and fire extinK guishers close at hand. • amiliarize staff with accident reporting, first aid and rescue faciliF ties. • Keep access routes for emergency services free. Just in case: Do the right thing • Trigger an emergency stop immediately. • Initiate first aid measures. • Rescue people...

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P80 SIMone Product Manual-13

4.4 Nameplate Specification Weight Weight (with packaging) Table top height adjustment Length Width Height Length packaged Width packaged Height packaged & 3Q Scientific GmbH GERMANY 4.2 Connection valuesElectrical Specification Supply voltage Frequency Power consumption, maximum Phase protection Power cord with safety plug type E/F and adapter for connector types B, D, E, F, G/BS1363, I, J, L and M (150 countries). 4.3 Operating conditions The device may only be operated indoors and in compliance with the following operating conditions: Work area Specification Temperature range Relative humidity...

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P80 SIMone Product Manual-14

5.1 Summary The SIMone™ birth simulator is used to simulate birth processes and procedures. Selectable scenarios show a range of complex birth processes. SIMone™ supports the work process for case history, examination, diagnosis and intervention. It is also used to practice the proper handling of medical devices as they are used in actual births with realistic haptics. 5.2 Scope of delivery 5.2.1 Main device A simulator with a haptic, visual and audio interface as a training module for use of the instruments used for operative vaginal delivery. SIMone™ is supplied with: • Simulator mechanics...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.