Lothar MedTec Treatment Optimiser Ambulatory Lung Diagnose System Instruction Manual

Lothar MedTec Treatment Optimiser Ambulatory Lung Diagnose System

Product Information

The Treatment Optimiser
The Treatment Optimiser is a version 1.0 product designed to provide optimized treatment solutions. Its release date is September 2023.

Indications for Use
The Treatment Optimiser is intended for use in various medical treatments.

Intended Purpose and Usability
The Treatment Optimiser is designed to assist medical professionals in optimizing treatment plans and providing the best possible outcomes for patients.

Pictograms and Safety Instructions in the Instruction Manual
The instruction manual contains pictograms and safety instructions to ensure safe and proper usage of the Treatment Optimiser.

Data Protection
Data protection measures are implemented to safeguard the privacy and confidentiality of user data.

Declaration of Conformity
A declaration of conformity is provided to certify that the Treatment Optimiser complies with relevant regulations and standards.

Practical Hints
The instruction manual includes practical hints to help users effectively utilize the Treatment Optimiser.

Minimum Requirements
The Treatment Optimiser has certain minimum requirements, which are detailed in the instruction manual.

Access to the Software
Instructions on how to access the software of the Treatment Optimiser are provided in the instruction manual.

Product Information and Settings
Detailed information about the product and its settings can be found in the instruction manual.

Operating Instructions
Step-by-step operating instructions for the Treatment Optimiser are outlined in the instruction manual.

Possible Sources of Error and Remedies
The instruction manual identifies possible sources of error and provides remedies to address them.

Safety and Operating Instructions
Safety and operating instructions are provided to ensure safe and effective usage of the Treatment Optimiser.

Deviation from the Intended Purpose
The instruction manual discusses the potential consequences and risks of deviating from the intended purpose of the Treatment Optimiser.

Medical Responsibility
Medical professionals using the Treatment Optimiser bear the responsibility for the medical decisions made based on its recommendations.

CE Notice
The Treatment Optimiser complies with applicable CE regulations and standards.

Maintenance
The instruction manual provides guidance on the maintenance of the Treatment Optimiser to ensure its optimal performance.

Literature
Additional literature resources related to the Treatment Optimiser are referenced in the instruction manual.

The Treatment Optimiser

The Treatment Optimiser is a medical device (software as a medical device; class IIa) consisting of a cloudbased software. It is a tool intended to quickly identify patients with a diagnosed respiratory disease who may benefit from a specialist review. The product provides a set of forms to collect information about a patient’s current health status related to a respiratory disease. This information is analyzed according to recognized guidelines (e.g., GINA) and aggregated.

Indications for Use

• Indications: Diagnosed asthma.
• Contraindications: There are no contraindications.

Intended Purpose and Usability

The Treatment Optimiser is used to collect information about a patient’s current health status related to a pre-diagnosed respiratory disease. The product then uses this information to provide decision support for general practitioners and their staff whether a patient would benefit from a specialist review. The Treatment Optimiser is used by general practitioners and their staff in the doctor’s office. The Treatment Optimiser decision support is based on recognized guidelines for respiratory disease management.
The system is suitable for patients age 12 and older.

Pictograms and Safety Instructions in the Instruction Manual
Following the ANSI (American National Standards Institute) recommendations for safety instructions, the following pictograms have been used in this instruction manual:

not avoided, could result in extremely serious injury or death. This signal word is reserved for extreme situations.
Warning| WARNING indicates a potentially hazardous situation which, if not avoided, could result in extremely serious injury or death.
Caution| CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Also used to indicate unsafe procedures.

Additional pictograms shown in the instruction manual and/or in the user interface:

| Observe the instruction manual and accompanying documents.
---|---
Attention| Important operating instructions and useful information. No information that warns of a dangerous or critical situation.
Note| Tips, info, and operating instructions.

Attention: Please also observe the safety and operating instructions in section 13.

Data protection

For data protection please refer to the Data Privacy Policy available on the landing page of the Treatment Optimiser (e.g., www.asthma- optimiser.com)

Declaration of Conformity
LOTHAR MEDTEC declares that the product described herein has been designed and manufactured in accordance with the following specifications and standards: Medical Device Directive 2017/745.
This device, which complies with class IIa for continuous operation according to Annex IX of the Directive, also complies with the essential requirements according to EN ISO 13485:2016. medical devices – quality management systems – requirements for regulatory purposes.
Certification authority: TUEV SUED (CE0123)
Certificate numbers: G10 102194 0002 Rev. 1

Practical Hints
Before initial operation, you should make yourself familiar with safe handling of the medical application and with the examination procedure.
Warning: Modifications to the product endanger product safety and lead to the loss of the operating license! LOTHAR MEDTEC assumes no liability for modifications made by the customer.

Minimum Requirements

To use the Treatment Optimiser, you need computer system with internet access and a current common browser software application. The internet connectivity requires availability and bandwidth typical for medical care.
Internet access to the URL of the Treatment Optimiser must not be blocked or otherwise restricted by the configuration of the local IT infrastructure.

Access to the Software

Access to the Treatment Optimiser is restricted, credentials can be received from an administrator.

Product Information and Settings
The product information (Unique Device Identifier (UDI), product and software version, manufacturer’s contact etc.) and settings page (settings and profile details) are accessible after logging into the application.

Operating Instructions

After logging into the Treatment Optimiser, in a “Quick Tour” the main functions of the software are explained. The “Quick Tour” is also accessible from the settings page. To use the software, follow the explanations in the “Quick Tour” and the instructions on screen.
If you suspect malfunction, please contact LOTHAR MEDTEC immediately:
LOTHAR MEDTEC GmbH, Magdalene-Schoch-Str. 5, 97074 Wuerzburg, Germany,
Phone.: +49 931 6193816-0, E-Mail: support@lothar-medtec.de

Possible Sources of Error and Remedies

| Error| Error source| Remedy
---|---|---|---
1| User interface cannot be loaded or refreshed| No adequate internet connection available| Make sure the computer system you are using is connected to the internet.

Restart the browser software.

Safety and Operating Instructions

This instruction manual describes the currently valid status of the product considering the essential requirements of MDR 2017/745. Strict adherence to the operating instructions is a prerequisite for the intended use of the Treatment Optimiser. Please follow the manufacturer’s specifications (technical data, explanation and compliance with the pictograms and other information).

Deviation from the Intended Purpose
Any non-compliance of the procedures described in this instruction manual will result in a deviation from the intended purpose. In this case, the operator/user must provide proof of compliance with all applicable essential requirements. This is possible with the implementation of a corresponding conformity assessment procedure within the scope of in-house-manufacture (compare § 12, section 1, last sentence,Medical Product Law). The operator/user is responsible for the proper performance of the conformity assessment, and he also assumes the complete product liability – not only the liability for the application/use of the medical device changed by him.

LOTHAR MEDTEC guarantees the safety, reliability, and function only if the product is used in compliance with the instruction manual.
This instruction manual is considered part of the product and must be always kept accessible.
If any potentially serious harm to a patient occurs during use of the product, such an occurrence must be reported immediately to the manufacturer and to the appropriate national competent authorities.

Medical Responsibility
The Treatment Optimiser is not intended to give professional or medical advice. General practitioners and their staff who use this tool should exercise their own clinical judgement and take into account applicable guidelines when making treatment decisions for their patients.

CE notice
The 0123 symbol indicates that the Treatment Optimiser complies with the provisions of the Medical Device Regulation 2017/745 of the European Commission. It also indicates that the Treatment Optimiser meets or exceeds the requirements of the applicable technical standards.

Maintenance

In the event of malfunctions, LOTHAR MEDTEC support team will be happy to advise you and to take care for remedy.

Literature
The Treatment Optimiser implements applicable parts of the following published recogniszed guidelines:
Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2023.

Available from www.ginasthma.org.
The Treatment Optimiser implements the following published reference models for calculation of patientspecific reference values:

Spirometry
Philip H. Quanjer, Sanja Stanojevic, Tim J. Cole, Xaver Baur, Graham L. Hall, Bruce H. Culver, Paul L. Enright, John L. Hankinson,Mary S.M. Ip, Jinping Zheng, Janet Stocks and the ERS Global Lung Function Initiative, Multi-ethnic reference values for spirometry for the 3–95-yr age range: the global lung function 2012 equations, Eur Respir J, 2012; 40.

Peak flow
Sterk PJ, Fabbri LM, Quanjer PH, Cockcroft DW, O’Byrne PM, Anderson SD, Juniper EF, Malo JL., Airway responsiveness.
Standardized challenge testing with pharmacological, physical and sensitizing stimuli in adults. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993; 16.

Contact
LOTHAR MEDTEC GmbH
Magdalene-Schoch-Str. 5
97074 Wuerzburg, Germany
Tel.: +49 931 6193816-0
E-Mail: info@lothar-medtec.de

These instructions for use were created using Microsoft Word. Adobe Acrobat Reader is required to open the PDF file.

Trademarks
Microsoft Word is a registered trademark of Microsoft Corporation. Adobe and Acrobat are registered trademarks of Adobe Systems Incorporated.

Contact
LOTHAR MEDTEC GmbH
Magdalene-Schoch-Str. 5
97074 Wuerzburg, Germany
Tel.: +49 931 6193816-0
E-mail: info@lothar-medtec.de

Copyright
All rights reserved, including in translation. No part of this manual may be reproduced in any form (print, photocopy or any other process) or processed, duplicated or distributed using electronic systems without written permission by LOTHAR MEDTEC.

Caution
Federal law restricts this device to sale by or on the order of a physician.

Note
This document contains proprietary information. All rights reserved. No part of this document may be copied, reproduced or translated into another language without the prior written permission of LOTHAR MEDTEC. LOTHAR MEDTEC reserves the right to change the information contained in this document without prior notice.
Names of persons appearing in examples of the operating instructions are fictitious. Any resemblance to living or deceased persons is therefore purely coincidental and not intended.
This document is available electronically at: https://www.lothar-medtec.de /instructions-for-use/
Release date: September 2023
Copyright © 2023 LOTHAR MEDTEC GmbH

References

• MEDTEC - your professional partner for medical equipment
• Global Initiative for Asthma - Global Initiative for Asthma - GINA
• Global Initiative for Asthma - Global Initiative for Asthma - GINA
• Instructions for Use – ALDS by LOTHAR MEDTEC GmbH

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