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Summary of Contents for MEDAP FINA RV O2/AIR
- Page 1 OPERATING INSTRUCTIONS MEDAP FINA FINE REGULATOR VAC GA 5752 3125 GB 10...
- 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. V10 2020-07 GA 5752 3125 GB 10...
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Page 3: Table Of Contents
Table of contents Table of contents Introduction .............................. 5 Foreword ..............................5 How to use these operating instructions ....................5 1.2.1 Abbreviations ..........................5 1.2.2 Symbols ............................5 1.2.2.1 Cross-references ....................... 5 1.2.2.2 Actions and responses ....................5 1.2.3 Definitions ............................ 6 1.2.3.1 Design of safety notes .................... - Page 4 Table of contents 3.2.1 General ............................17 3.2.2 Version A ............................ 17 3.2.3 Version B ............................ 18 Mounting accessories ..........................18 3.3.1 General ............................18 3.3.2 Connection of the mechanical overflow protection ..............19 3.3.3 Connection of the hydrophobic bacterial and viral filter ............. 19 3.3.4 Connection of the septic fluid jar with integrated overflow protection ........
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Page 5: Introduction
Introduction Foreword Introduction Foreword 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. -
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: Disposal
Introduction Disposal Symbols Identification Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Serial number’. Labelling in compliance with the IEC 60601-1 standard. Symbol for ‘Follow operating instructions’. Material designation for the plastic PA (polyamide). Packaging label. Symbol for ‘Keep dry’. Packaging label. -
Page 8: Atmos Products
Introduction Overview 1.3.3 ATMOS products ATMOS will take back used products or those which are no longer in service. Please contact your ATMOS representative for more detailed information. Overview 1.4.1 FINA Fine regulator VAC Fig. 1: Overview of FINA fine regulator VAC 1 Adjusting screw 5 Vacuum connection tube B Inner diameter 6 mm... -
Page 9: Versions Of Fina Fine Regulator Vac
Introduction Basic requirements 1.4.2 Versions of FINA fine regulator VAC 1 1 0 0 1 1 1 1 1 1 2 2 Fig. 2: Overview of FINA fine regulator VAC versions 1 Version A 6 Equipment rail Tapping unit with integrated gas pin 7 Rail clamp 2 Terminal unit VAC 8 Locking lever... -
Page 10: Applicable Standards
Introduction Basic requirements 1.5.2 Applicable standards The product satisfies the basic requirements set forth in Annex I to Council Directive 93/42/EEC concerning medical devices (Medical Devices Directive) as well as the applicable national (German) codes and the Medical Products Act (MPG) in Germany. This is certified by compliance with harmonised standards such as IEC 60601-1 and related standards and the respective special sections. -
Page 11: Versions Of Fina Fine Regulator Vac
The product is available in the following versions: • FINA fine regulator VAC Wall MEDAP (REF 5752 3712) • FINA fine regulator VAC Wall DIN (REF 5752 3713) • FINA fine regulator VAC equipment rail (REF 5752 3714) 1.5.5... -
Page 12: Hydrophobic Bacterial And Viral Filter
Introduction Basic requirements Prerequisites • The vacuum connection tube must comply with the hospital's standards for hygiene. • The inner diameter of the vacuum connection tube must match the outer diameter of the hy- drophobic bacterial and viral filter. • The inner diameter of the vacuum connection tube must match the outer diameter of the tube connector on the bacterial and viral filter. -
Page 13: Utensil
Introduction Basic requirements 1.5.5.7 Utensil The suction catheter, lance, etc., are referred to as utensils. The utensils are used to extract septic fluids. Prerequisites • The inner diameter of the utensil's connector must match the outer diameter of the fingertip. •... -
Page 14: Safety Notes
Safety notes General safety notes Safety notes General safety notes WARNING! Risk of injury! ATMOS products may be used only when fully functional. Ensure that the ATMOS product is fully functional and in good working order prior to use. WARNING! Risk of injury! Hazard resulting from incorrect handling. - Page 15 Safety notes Product safety notes DANGER! Risk of injury to mucous membranes! Endobronchial aspiration in paediatrics and neonatology requires particularly careful limitation of the vacuum. For the regular endobronchial aspiration in paediatrics and neonatology, ATMOS also offers paediatric versions with a higher level of setting convenience.
- Page 16 Safety notes Product safety notes WARNING! Risk of injury! The product may not be used for the following purposes or under the following conditions: • Never throw, hit or drop the unit. • The product is not suitable for vacuum extraction. •...
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Page 17: Initial Operation
Initial operation Equipment inspection Initial operation Equipment inspection DANGER! Equipment inspection! Only components which are in perfect condition can ensure proper functioning of the product. The components will thus have to be carefully inspected before using the unit. WARNING! Infection hazard! Contaminated components may endanger the health of staff and patients. -
Page 18: Version B
Initial operation Mounting accessories 3.2.3 Version B Tapping units with rail clamp and NIST connection With the upper edge of the guide groove at the front, position the rail clamp (1) at a slight angle on the equipment rail (2) and then press it against the equipment rail and allow it to click into place. -
Page 19: Connection Of The Mechanical Overflow Protection
Initial operation Mounting accessories 3.3.2 Connection of the mechanical overflow protection Connection of the mechanical overflow protection Plug the overflow protection device (1) directly onto the tube connector (2) on the housing of the tapping unit and press upwards until it stops. ... -
Page 20: Connection Of The Septic Fluid Jar With Integrated Overflow Protection
Initial operation Mounting accessories 3.3.4 Connection of the septic fluid jar with integrated overflow protection Connection of the septic fluid jar with integrated overflow protection Attach the connection tube (1) to the tube connector (2) on the housing of the tapping unit and connect it to the tube connector of the septic fluid jar. -
Page 21: 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. NOTE Connecting several septic fluid jars in series can cause delayed suction effect and reduced suction power. - Page 22 Operation Setting the flow NOTE Check the vacuum setting once again immediately before using the unit! Open the adjustment screw (1) by turning it anticlockwise. Use the adjustment screw to set the flow rate to the required value for the treatment. ...
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Page 23: Taking The Unit Out Of Operation
Taking the unit out of operation Setting the flow Taking the unit out of operation NOTE Please refer to the manufacturer’s instructions for the particular terminal unit for information on detaching the gas probe from the terminal unit. Remove the suction tube from the patient. ... -
Page 24: 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 25: Cleaning
Cleaning and disinfection Cleaning Cleaning 6.2.1 General NOTE Use only all-purpose cleaners which are slightly alkaline (soap solution) and contain surfactants and phosphates as the active cleaning agents. In the event of heavily contaminated surfaces, use concentrated all-purpose detergent. CAUTION! Improper cleaning can cause property damage! Residues of physiological saline solutions (e.g. -
Page 26: Suitable Disinfectants
Cleaning and disinfection Product-specific safety notes CAUTION! Material damage due to excessive exposure times! Exceeding the specified exposure time of the disinfectant may damage the surfaces. Observe the exposure time specified by the disinfectant manufacturer. 6.3.2 Suitable disinfectants Only surface disinfectants based on the following combinations of active ingredients may be used for disinfection: •... - Page 27 Cleaning and disinfection Product-specific safety notes DANGER! Risk to patient! Oversuction of products results in them no longer being functional. There is considerable risk to the patient if the tapping unit is not cleaned properly after being exposed to oversuction, as safety equipment could be clogged. After oversuction, products must be dismantled and cleaned thoroughly by authorised service staff.
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Page 28: Maintenance
Maintenance General Maintenance General Maintenance, repairs and periodic tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures, the person must have the necessary test devices and original spare parts. ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. -
Page 29: Repairs
Maintenance Repairs Defect Source of malfunction Troubleshooting Oversuction of device Tapping unit mounted at an Operate tapping unit in a vertical despite protective system angle position only Overflow protection device Clean overflow protection device contaminated No foam inhibitor used Use standard commercial foam inhibitor No hydrophobic filter used Use hydrophobic filter... -
Page 30: Technical Specifications
Technical specifications General Technical specifications General Classification as per Annex IX to Directive 93/42/EEC Class IIa Technical specifications Nominal pressure, gas supply -100 kPa to -60 kPa* Flow rate (freeflow)** Approximately 30 l/min Performance class HF/HV (High Flow / High Vac) * 100 kPa = 1 bar = 1000 mbar = 750 mmHg ** in accordance with EN 10079-3. -
Page 31: 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 1698 Mechanical overflow protection 5752 3330 Aspiration set for equipment rail / 1 l 5752 5669 Aspiration set for wall mount / 1 l Tab. - 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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