Summary of Contents for Atmos MEDAP FINA FLOW
- Page 1 OPERATING INSTRUCTIONS FLOWMETER MEDAP-FINA FLOW MEDAP-FINA DFLOW GA 5752 2804 GB 18...
- Page 2 Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these operating instructions as a result of ongoing product development. V18 2020-07 GA 5752 2804 GB 18...
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Page 3: Table Of Contents
1.2.4 Symbols used ..........................6 Disposal ..............................8 1.3.1 Packaging ............................ 8 1.3.2 ATMOS products .......................... 8 Overview of FINA FLOW flowmeter ......................9 Basic requirements ........................... 10 1.5.1 Use in accordance with the intended purpose ................10 1.5.2 Applicable standards / directives ....................10 1.5.3... - Page 4 Table of contents Operation ..............................19 Function test ............................. 19 Setting the flow for treatment ........................19 Taking the unit out of operation ......................21 Cleaning and disinfection ........................22 General ..............................22 Cleaning ..............................23 6.2.1 General ............................23 6.2.2 Cleaning procedure ........................
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Page 5: Introduction
Your facility has selected the leading-edge medical technology made by ATMOS. We sincerely appreciate the trust you have placed in us. How to use these operating instructions These operating instructions are provided to familiarise you with the features of this ATMOS product. They are subdivided into several chapters. Please note: •... -
Page 6: Definitions
Introduction How to use these operating instructions 1.2.3 Definitions 1.2.3.1 Design of safety notes Pictogram Descriptor Text The text for the safety note DANGER! describes the type of risk and Indicates a direct and immediate risk to how to avert it. persons which may be fatal or result in most serious injury. - Page 7 Introduction How to use these operating instructions Symbols Identification Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Name and address of the manufacturer as well as date of manufacture’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Date of manufacture’. Labelling in compliance with the ISO 15223-1 standard.
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Page 8: Disposal
The product or some of its components may be contaminated after use. Clean and disinfect the product before disposal. 1.3.1 Packaging The packaging is made of materials compatible with the environment. ATMOS will dispose of the packaging materials upon request. 1.3.2 ATMOS products ATMOS will take back used products or those which are no longer in service. -
Page 9: Overview Of Fina Flow Flowmeter
Introduction Overview of FINA FLOW flowmeter Overview of FINA FLOW flowmeter Fig. 1: Overview of FINA FLOW flowmeter 1 Flowmeter viewing tube 9 Version A Tapping unit with integrated gas pin 2 Control valve 3 Flowmeter outlet (UNF 9/16") 10 Plug 4 Adapter for humidifier (UNF 9/16”... -
Page 10: Basic Requirements
Introduction Basic requirements Basic requirements 1.5.1 Use in accordance with the intended purpose Product As per Annex IX to the Medical Devices Directive 93/42/EEC, this product belongs to class IIa. In accordance with this directive, the product may only be used by persons who have been instructed how to use this product by an authorised person. -
Page 11: Versions Of Fina Flow / Dflow Flowmeter
Introduction Basic requirements Patient groups: Patients of all ages Application organ: Lung Application time: For continuous operation; in practice, short-term use on the patient (< 30 days) Application site: The application site is the clinical environment and doctor’s practices which have a central oxygen / compressed air system. The application of the product may only be performed by medically trained and instructed staff. -
Page 12: Possible Applications
Introduction Basic requirements The product is available in the following versions: • FINA FLOW O 15 Wall DIN (REF 5752 3681) • FINA FLOW O 15 NIST connection, equipment rail (REF 5752 3682) • FINA FLOW O 15 Wall MEDAP (REF 5752 3680) •... -
Page 13: Tube Adapter For Air And O2
Introduction Basic requirements 1.5.6.4 Tube adapter for AIR and O2 The tube adapter is used to connect the tapping unit and the connection tube. The internal thread of the tube adapter must match the external thread of the tube connector of the flowmeter outlet (UNF 9/16"). -
Page 14: Safety Notes
Safety notes General safety notes Safety notes General safety notes DANGER! Incorrect use can result in fatalities! Instructions for using components made by other manufacturers are not part of these operating instructions. Ensure that the manufacturer's instructions are followed. DANGER! Observe hygiene guidelines! Contaminated components may be hazardous to the patient's health. - Page 15 Safety notes Product safety notes CAUTION! Property damage! Exposure to UV rays can cause material fatigue. The stability would no longer be ensured. Do not expose the product to strong UV light. CAUTION! Observe ambient conditions! The precision, operation, mechanical stability and tightness of the product cannot be guaranteed if the ambient temperature range is undercut or exceeded.
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Page 16: Initial Operation
Initial operation Product testing Initial operation Product testing DANGER! Imprecise display in the event of deviations in system pressure! If the system pressure of 500 kPa ± 10% is undercut or exceeded, it will no longer be possible to accurately display the measured values of the flowmeter. DANGER! Fluctuations in flow rate! Flow accuracy may be influenced by the following factors:... -
Page 17: Version A
Initial operation Mounting accessories 3.2.2 Version A Tapping unit with integrated gas pin The tapping unit (1) is plugged directly into the terminal unit (2). Fig. 2: Version A 3.2.3 Version B Tapping units with rail clamp and NIST connection ... -
Page 18: Connection Of The Bubble Humidifier (Ref 5752 5315)
Initial operation Mounting accessories WARNING! Tensile forces! Hold the basic unit with one hand when installing or removing accessories in order to compensate for the tensile forces which are created. 3.3.2 Connection of the bubble humidifier (REF 5752 5315) Connecting the bubble humidifier ... -
Page 19: Operation
Operation Function test Operation Function test DANGER! Function check! The product is used in the treatment of patients. Any restriction in the unit's performance can result in serious complications in treatment. Perform a complete function check every time before using the unit. Perform a complete function check of the tapping unit prior to use. - Page 20 Operation Setting the flow for treatment NOTE When applying oxygen in its function as a medication as per the monograph in the European Pharmaceuticals Reference, it is absolutely necessary to measure the flow rate. NOTE The product only provides the patient with additional oxygen. The monitoring of the patient is the responsibility of the user.
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Page 21: Taking The Unit Out Of Operation
Taking the unit out of operation Setting the flow for treatment Taking the unit out of operation WARNING! Disengage! When the product is disengaged (removed) from the terminal unit, the pressure energy may cause recoil. Use the terminal unit in parking position or support when disengaging. NOTE To protect the product from damages, cover with cloths when storing. -
Page 22: Cleaning And Disinfection
Cleaning and disinfection General Cleaning and disinfection General The product must be wipe or spray disinfected after every use. DANGER! Risk due to incorrect use of detergents and disinfectants! It is strictly advised to observe the manufacturer’s instructions regarding how to use the detergents and disinfectants as well as to observe the valid hospital hygiene rules. -
Page 23: Cleaning
Cleaning and disinfection Cleaning CAUTION! Improper cleaning and disinfection can cause property damage! Perform visual and functional inspections after each cleaning and disinfection process. Cleaning 6.2.1 General NOTE In the event that product surfaces are very dirty, carry out an additional cleaning procedure before disinfecting the product. -
Page 24: Disinfection
Cleaning and disinfection Disinfection Disinfection 6.3.1 General NOTE In the event that product surfaces are very dirty, carry out an additional cleaning procedure before disinfecting. CAUTION! Material damage due to excessive exposure times! Exceeding the specified exposure time of the disinfectant may damage the surfaces. -
Page 25: Disinfection Procedure
Cleaning and disinfection Special safety notes 6.3.3 Disinfection procedure After each cleaning process, wipe or spray disinfect the product in accordance with the instructions of the disinfectant manufacturer. Ensure that the product is free of disinfectant residue. Perform visual and functional inspections. Special safety notes DANGER! Tension cracks! -
Page 26: Maintenance
ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected. -
Page 27: Repairs
[ page 26]. If defects are detected, the product may not be used any longer. Make a note of the defects and the REF number on the type plate and inform your ATMOS representative. Observe the information in chapter Sending in the device [ page 27]. - Page 28 Place form QD 434 ‘Delivery complaint / return shipment’ and the respective decontamination certificate in an envelope. Affix the envelope to the outside of the package. Send the product to ATMOS or to your dealer. GA 5752 2804 GB 18...
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Page 29: Technical Specifications
Technical specifications General Technical specifications General Classification as per Annex IX to Directive 93/42/EEC Class IIa Ambient conditions Temperature: Shipping / storage −15 °C to +50 °C Temperature: Operation +15 °C to +40 °C Relative humidity: Shipping / storage 10% to 95% Relative humidity: Operation 30% to 75% Atmospheric pressure: Shipping / storage... -
Page 30: Approved Accessories
Approved accessories Accessories Approved accessories The following accessories are not part of the scope of delivery and must be ordered separately. Accessories 5752 2746 Tube adapter, metal 4 mm, 6 mm, 8 mm 5752 5316 Tube adapter, plastic 4 mm, 6 mm, 8 mm 5752 5315 Bubble humidifier 5752 5707... - Page 31 Notes...
- Page 32 Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch GERMANY Phone: +49 7653 689-0 www.atmosmed.com...
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