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Inspiration Tecotherm Neo User Manual

Inspiration Tecotherm Neo
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IfU TECOTHERM NEO TN300 EN - 01.doc
TEC COM GmbH
TECOTHERM NEO
MEDICAL EQUIPMENT for HYPOTHERMIA
of NEONATE and INFANTS
Instructions for Use

Table of Contents

Other manuals for Inspiration Tecotherm Neo

Questions and Answers:

Inspiration Tecotherm Neo Specifications

General IconGeneral
Cooling MethodWater-based
ConnectivityUSB, Ethernet
Patient PopulationNeonates
Temperature Range4°C to 42°C
Weight15 kg
Power Supply100-240V, 50/60Hz
DisplayTouchscreen

Summary

Preface

Intended Use

Details the intended use of the TECOTHERM NEO system for controlled cold & heat treatment procedures.

Contraindications for Use

Lists known contraindications and adverse effects for the TECOTHERM NEO system.

Operator Profile

Defines the required qualifications and training for personnel operating the TECOTHERM NEO.

Informations for Customers Service & Technical Support

Short Description of the Equipment

Symbols, Indications

Warnings, Precaution Guidelines

Precaution Notes for Placement

Provides essential guidelines on how and where to safely place the TECOTHERM NEO device to ensure optimal operation and safety.

TECOTHERM NEO Hypothermia System

Description of the System

Details the TECOTHERM NEO system components and accessories, including the main device and application parts like mattresses and probes.

Treatment and Operation Modes

Explains the three distinct treatment modes: Programmable Complete, Constant Rectal, and Constant Mattress Temperature, and their operational aspects.

Indicators and Operation Key Elements

Identifies and describes the front panel indicators, buttons, and display screen layout of the TECOTHERM NEO.

Application Part, External Temperature Probes

Details the types and usage of Rectal and Skin Temperature Probes for accurate patient temperature monitoring.

Hoses, Fluid Circulation Line

Describes the hose set, its material, and how it connects the TECOTHERM NEO device to mattresses and cool pads.

Fill-up Set for Filling/Refilling TECOmed Thermalizing Fluid

Explains the fill-up set used for adding or replenishing TECOmed fluid into the system's internal fluid tank.

TECOmed Thermalizing Fluid

Details the composition and supply of TECOmed, the circulating fluid used for patient thermal regulation.

Mattresses, Cool Wraps, Pads, Cool parts and Foil layer

Describes the various application parts like mattresses and cool wraps used for patient thermal regulation, including their specifications.

MENU and the User Interface / USB Connection

Covers the device's menu system, user interface elements, and USB port functionality for data transfer and updates.

TECOTHERM NEO Hypothermia System Putting into Operation

Initial Set Up / Initial Operation

Outlines the initial setup and operator training required before using the TECOTHERM NEO system for the first time.

Initial Operation by the Customer: Pre-operation Check Up

Details the critical pre-operation checks the customer must perform to ensure safe and proper system operation.

Initial Operation by the Customer

Guides the customer through the initial operational steps, including connecting probes, starting the system, and performing self-tests.

Stop Operation/ Turn Off Device

Explains the procedure for safely stopping or turning off the TECOTHERM NEO system to prevent data loss.

Filling / Refilling Procedures

Provides step-by-step instructions for filling or refilling the TECOTHERM NEO with TECOmed fluid, including alarm handling.

Preparation of Empty or Partially Filled Mattress

Details how to prepare mattresses, including filling them with the correct amount of TECOmed fluid.

Application of Mattresses

Provides guidelines on how to correctly apply mattresses and cool wraps to the patient, avoiding kinks and ensuring proper fluid circulation.

Hygienic Requirements

Cleaning and Disinfecting TECOTHERM NEO

Outlines the procedures for cleaning and disinfecting the TECOTHERM NEO device, hoses, and QDC connectors, ensuring hygiene.

Mattresses, Thermally Insulated Hoses, Tubing

Specifies the cleaning and disinfection requirements for reusable mattresses, hoses, and tubing to maintain sanitary conditions.

Temperature Probes

Covers the disinfection and sterilization procedures for rectal and skin temperature probes before they are applied to the patient.

Storage

Storage of the TECOTHERM Device

Provides instructions on how to store the TECOTHERM NEO basic unit, mains cable, fill-up set, and hoses to protect them from damage and dust.

Storage of Mattresses

Details the proper storage conditions for mattresses, including temperature and environmental requirements for both empty and filled mattresses.

Storage of TECOmed

Gives guidelines for storing TECOmed fluid containers, emphasizing sealing, temperature, and safety precautions.

Transport

Offers advice on the safe transport of the lightweight TECOTHERM NEO system over short distances or with a trolley.

Alarms, Malfunctions, Failures, Signals and Troubleshooting

System Alarm, System Failure

Explains the 'System Alarm' and 'System Failure' indicators, their causes, and troubleshooting steps for internal system issues.

Temperature Alarm

Describes the 'Temperature Alarm', its causes like probe issues or deviations, and troubleshooting steps to resolve it.

Alarm No Flow

Covers the 'No Flow' alarm, its causes related to circulation issues like kinks or pump failure, and management steps.

Alarm Fluid Level Too Low

Details the 'Fluid Level Too Low' alarm, its causes like leakage, and troubleshooting procedures for refilling or inspecting the system.

Alarm No Mains Power

Explains the 'No Mains Power' alarm, its causes related to power supply issues, and troubleshooting steps for fuses or internal defects.

Fluid Escapes from the TECOTHERM NEO System

Addresses situations where fluid escapes from the system, differentiating between device leaks and mattress/hose leaks, with management steps.

Fault Software Update Error

Describes errors encountered during software updates and provides guidance on how to proceed or seek assistance.

Training & Qualification of Personnel

Service, Preventive Maintenance, Software Update

Service & Maintenance

Emphasizes the importance of regular system inspection and calibration by authorized service providers for long-term safe operation.

Cleaning the Ventilation Hole Structure (Device Bottom)

Provides instructions for cleaning the ventilation holes on the device bottom, recommending periodic inspection and hygienic cleaning.

Substitution of TECOmed Fluid

Details the procedure and frequency for substituting the TECOmed fluid in the TECOTHERM NEO system, recommending replacement every 3 months.

Substitution of TECOmed Fluid in Mattresses and Cool Wraps

Explains the need for TECOmed fluid substitution in mattresses and cool wraps if stored for a longer time.

Software Update

Informs customers about software updates, stating they will be notified by the manufacturer or service provider.

Check/ Calibration of Temperature Probes

Recommends periodic checking and calibration of temperature probes every 2 years for accurate patient temperature measurements.

Safety, Reliability

Highlights the importance of using original components, parts, and accessories for safe and reliable operation of the TECOTHERM NEO system.

Technical Data / TECOTHERM NEO Specification

CE Conformity Declaration

Disposal

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