KaWe 136104 QM-1-025O Dual Head Educational Stethoscope User Manual

: June 12, 2024
: KaWe

KaWe 136104 QM-1-025O Dual Head Educational Stethoscope

Product Information

The QM-1-025O is a stethoscope manufactured by KaWe. It is a diagnostic tool used for auscultation of heart sounds/murmurs, lung murmurs, and other audible parameters. The stethoscope consists of a headset, sound tube, and chest piece. It is designed to meet the requirements of Regulation (EC) 2017/745 and is classified as a medical device class I. The stethoscope is available in different models, including Schwestern-Lehr Plano, Petiphon, Pinard klein, Schwestern-Lehr Duo, Profi-Kardiology, Prestige-Standard, Prestige-Standard light, Top-Kardiology, Prestige-Child, Prestige-Child light, Planet, Prestige- Baby, Prestige-Baby light, Planet Air, KaWe COLORSCOP Duo, Double, Rapport/Rapport Black-Line KaWe COLORSCOP Plano, and Single. Color options for the stethoscope can be found in the general catalog of KaWe’s company website.

Product Usage Instructions

Before using the QM-1-025O stethoscope, please read the User’s Manual thoroughly and carefully. Adhere to the instructions provided in the manual and keep it for future reference if necessary. If you have any questions, contact the service department whose address is indicated on the back of the manual.

Symbols Used

Attention symbol: Indicates the need to follow the User’s Manual
Article number: Identifies the product
Batch number: Identifies the manufacturing batch
Serial number: Uniquely identifies each individual product
Manufacturer: The company responsible for manufacturing the stethoscope
CE mark: Indicates compliance with European regulations
GOST-R certification: Certification for export to Russia
Latex free: Indicates that the stethoscope does not contain latex
Disposal as household waste: Instructions for proper disposal
Store in a dry place: Guidelines for storage
Medical products: Indicates that the stethoscope is classified as a medical device

Purpose and Intended Use

The purpose of the QM-1-025O stethoscope is to facilitate medical examinations by allowing healthcare professionals to listen to various bodily sounds. The intended use is to comply with all instructions provided in the User’s Manual and adhere to basic rules and directives. It is important to note that any other use of the stethoscope may result in damage, and the manufacturer does not accept liability for such damage.

Hygienic Preparation

To ensure proper hygiene, the stethoscope should be cleaned and disinfected. After cleaning, make sure all parts are dry before reassembling the stethoscope. Sterilization may also be required in certain situations.

Safety Instructions and Contraindications

The User’s Manual provides safety instructions and contraindications that should be followed to ensure safe usage of the stethoscope.
Please refer to pages 4-5 of the application manual or the company’s general catalog for images of different stethoscope models and visit the company’s website for color options.
Please read this User‘s Manual thoroughly and carefully before attempting to use this product and heed the given care instructions.

WORKING GRAPH

ACCESSORIES

INTRODUCTION

We would like to thank our valued customers for their decision to purchase a KaWe product. Our stethoscopes are characterized by high quality and durability. Our products meet the require-ments of Regulation (EC) 2017/745 (European Regulation on Medical Devices) and are classifi ed as medical devices class I.
Please read this manual carefully, adhere to it strictly, and keep it for future reference if necessary.
Before using the product, carefully study operation rules, especi-ally care requirements.
If you have any questions, please contact the service depart-ment (the manufacturer’s address is indicated on the back).
Images of the diff erent stethoscope models are shown on pages 4-5 of this application manual. Color options can be found in the general catalog of our company at
https://www.kawemed.com/download/broschueren/ or can also be viewed at your specialist dealer.

Symbols used in the application manual and on packaging

Purpose and intended use

The stethoscope is a diagnostic tool and consists of a headset, sound tube and chest piece. It is used for auscultation of heart sounds/murmurs, lung murmurs, and other audible parame-ters.
Depending on the type of examination, the stethoscope is applied to the appropriate area of the body and used at low pressure. On double-sided stethoscopes, you can choose one or another input channel (funnel or membrane).
Intended use is the compliance with all instructions in this ap-plication manual as well as basic rules and directives. The ma-nufacturer does not accept any liability for damage resulting from any other use.
Target patient groups: adults, children and infants.
The products must only be used by authorized specialized per-sonnel.

Safety rules/contraindications

To avoid injury, do not use a stethoscope without ear tips! If the rubber is damaged or has come off, the ear tips must be replaced before the next use.
The rotatable ear tips have the rubber cover attached. Always make sure that it is correctly positioned before use.
Do not touch water with stethoscope.
Loud sound can interfere with the perception of noise.
Do not sterilize in autoclaves.
Keep the stethoscope away from heat, solvents, and oils.
Before each use, please check whether the stethoscope is operating properly. Do not use the device in case any damage is detected.
Only original spare parts and accessories from KaWe may be used.

Application

The basic principle of auscultating with a stethoscope is the “fluctuating air column”. For sound transmission, a closed air column must be formed.

When putting on a stethoscope with a headset, the bows are applied so that the ear tips are directed slightly forward, towards the examiner’s nose, so that the anatomical structure of the ear contributes to their close contact with the acoustic meatus.
Apply the membrane or funnel to the examined place. The following models have a double function of membrane/funnel:
- Planet & Planet Air
- Prestige & Prestige light
- Double
- Rapport
- Profi Cardiology
- KaWe COLORSCOP Duo
- Duo Stethoscope for nurse training
Funnel or membrane can be selected with a double movement of the stethoscope head. If the membrane is open, the funnel closes and vice versa.
Turn left or right
on Planet & Planet Air model (red point = membrane open)
180° rotation
- other double head models
- Prestige & Prestige light model (ear symbol = open side)
Membrane-head stethoscopes are used either for auscultation of anatomically curved places and/or in cases where the low frequency ranges of the auscultation signal are of little or no importance for the diagnosis.
The funnel on the chest is used for low frequency diagnostics. In particular, this is required for cardiac auscultation. The edges of the funnel must adhere tightly to the entire examined part of the body.

Preparing for operation

Check the stethoscope for damage and contamination (especially diaphragm, hoses and headset incl. ear-tips). The system must be closed.
Check that the ear-tips are properly seated.
Individually adjust the headset.
After successful completion of the inspection and after appro-priate hygienic preparation, the stethoscope can be used to ex-amine patients.

Hygienic preparation

Clean and disinfect the stethoscope periodically to prevent cross contamination.

Cleaning and disinfection

After examining each patient, the stethoscope is to be cleaned and disinfected with a 70% alcohol solution (for example, a soaked tissue). The duration of exposure of the agent used must be taken into account.
Besides, perform a thorough cleaning of the individual compo-nents of the stethoscope periodically. Use a 70% alcohol soluti-on or a mild soap solution. For thorough cleaning the ear tips and membrane may be removed. Remove the corresponding retaining ring on the diaphragm. Handle the diaphragm with care to prevent damage.
Reassemble the stethoscope components only after they are completely dry.
Automatic cleaning is not allowed.

Sterilization
Stethoscopes are not suitable for sterilization processes.

Transportation and storage

Stethoscopes are to be stored and transported protected from dust, moisture and contamination.

Ambient temperature

Room temperature.
Do not expose to extreme heat or cold.

Storage
Store the stethoscope in a separate container (for example, in a standard plastic bag). The bag is to be large enough to store the instrument to avoid bends after closing the bag.

Maintenance and Service

The end of the useful life is usually determined by wear and tear. Damaged parts are to be sorted out and replaced immediately. For repairs, contact your specialist dealer.

Accessories and Spare parts

Accessories and spare parts can be found in the general catalog of our company at https://www.kawemed.com/download/broschueren/ or can also be viewed at your specialist dealer.

Disposal

The product is to be disposed in accordance with local environ-mental regulations.

Annex

Warranty
In case of proper handling and adherence to the rules laid down in this application manual, as well as the use of original KaWe spare parts, the statutory warranty period of two years from the date of sale is valid. For other questions and if repair is required, contact your specialized dealer.

Contact information
Please contact your specialist dealer or directly the manu-facturer (see back for address).

Basic UDI-DI
4030155KaWe06SU

Instructions for service personnel and patients
In case of problems during the device use, it is necessary to immediately contact the manu-facturer and the competent authorities of the re-levant member state of the Union, in which the service personnel or the patient are located.