Related Manuals for MEDAP MEDAP-BORA UP 2080
Summary of Contents for MEDAP MEDAP-BORA UP 2080
- Page 1 OPERATING INSTRUCTIONS UNIVERSAL ASPIRATOR MEDAP-BORA UP 2080 MEDAP-BORA UP 2080 OP GA 5752 2300 GB 26...
- 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. V26 2020-02 GA 5752 2300 GB 26...
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Page 3: Table Of Contents
Table of contents Table of contents Introduction .............................. 6 Foreword ..............................6 How to use these operating instructions ....................6 1.2.1 Abbreviations ..........................6 1.2.2 Symbols ............................6 1.2.2.1 Cross-references ....................... 6 1.2.2.2 Actions and responses ....................6 1.2.3 Definitions ............................ 7 1.2.3.1 Design of safety notes .................... - Page 4 Table of contents Product safety notes ..........................19 Initial operation ............................22 General ..............................22 Variations in use ............................22 3.2.1 Portable variation ........................22 3.2.2 Aspirator on trolley ........................23 3.2.2.1 Inserting the catheter holder (REF 5750 8002) ............24 3.2.3 Aspirator on equipment rail ......................
- Page 5 Table of contents Cleaning and disinfection ........................42 General ..............................42 Cleaning ..............................43 6.2.1 General ............................43 6.2.2 Cleaning procedure ........................44 Disinfection ............................... 44 6.3.1 General ............................44 6.3.2 Suitable disinfectants ......................... 44 6.3.3 Disinfection procedure ....................... 45 6.3.4 Disinfection procedures ......................
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Page 6: 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 7: 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 8 Introduction How to use these operating instructions Symbols Identification Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Product number’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Name and address of the manufacturer as well as date of manufacture’.
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Page 9: Disposal
Introduction Disposal Symbols Identification Packaging label. Symbol for ‘Fragile! Handle with care’. Packaging label. Symbol for ‘Top’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Temperature limitations’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Relative humidity’. Labelling in compliance with the ISO 15223-1 standard. -
Page 10: Übersicht
Introduction Übersicht Übersicht 1.4.1 BORA UP 2080 OP 1 1 0 0 1 1 0 0 1 1 3 3 1 1 3 3 1 1 1 1 1 1 1 1 1 1 2 2 1 1 2 2 1 1 4 4 1 1 4 4 1 1 5 5... -
Page 11: Bora Up 2080
Introduction Übersicht 1.4.2 BORA UP 2080 1 1 1 1 1 1 0 0 1 1 2 2 1 1 3 3 Fig. 2: Overview BORA UP 2080 1 Aspirator 8 Mains cable 2 Handle 9 ON switch 3 Equipment mount interface 10 Power control light 4 Rail clamp 11 OFF switch... -
Page 12: Trolley
Introduction Basic requirements 1.4.3 Trolley Fig. 3: Overview of trolley (REF 5752 5320) 1 Handle screw 3 Double castors with locking brake 2 Equipment rail 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. Gemäß... -
Page 13: Intended Purpose
Introduction Basic requirements through the application of the corresponding standards which have been harmonised with Directive 93/42/EEC. 1.5.3 Intended purpose Name: BORA UP 2080 BORA UP 2080 OP Main function: Aspiration of secretion, blood, serous fluids, vomiting and rinsing fluids along with any contained particles and temporary collection of these fluids Medical indications / For all applications which require aspiration, such as general... -
Page 14: For Use In Cardiac Surgery And Surgery Of The Central Nervous System (Cns)
Introduction Basic requirements Sterility: No sterile product Single-use product / The device and parts of the accessories are reusable. For reprocessing: information on reprocessing, cleaning and disinfection, please see the operating instructions. 1.5.3.1 For use in cardiac surgery and surgery of the central nervous system (CNS) The basic version of the product is a BF protection class device. -
Page 15: Interface Description
Introduction Basic requirements 1.5.4 Interface description 1.5.4.1 Hydrophobic bacterial and viral filter NOTE The use of a hydrophobic bacterial and viral filter is not necessary if a suitable hydrophobic bacterial and viral filter is integrated for a specific purpose in the septic fluid jar of a disposal aspiration system. -
Page 16: Suction Tube
Introduction Basic requirements Prerequisites • Must be equipped with an overflow protection device or must be connected to an external overflow protection system. • Low leakage • Capacity of 1 l to 5 l. • Always fasten the septic fluid jar securely. •... -
Page 17: Application Sets
Introduction Basic requirements Prerequisites • Der Spülbehälter muss ein Fassungsvolumen von mindestens 250 ml haben. • The rinsing fluid jar shall be easy to clean and disinfect. 1.5.4.9 Application sets Application sets augment the basic unit. Application sets can be configured as required, using individual accessories. -
Page 18: Safety Notes
Safety notes General safety notes Safety notes General safety notes DANGER! Danger to life! For open heart operations and those to the central nervous system, there may be equipotential bonding between the user and the patient. The product may not be used with components for aspiration that are metal and conductive. -
Page 19: Product Safety Notes
Safety notes Product safety notes DANGER! Infection hazard! The bacterial filter paper provides additional protection against contamination of the ambient air. Do not operate the aspirator without a bacterial filter paper. WARNING! Risk of injury! ATMOS-Produkte dürfen nur in voll funktionsfähigem Zustand eingesetzt werden. Check to ensure that the ATMOS product is fully functional and in good working order prior to use. - Page 20 Safety notes Product safety notes WARNING! Risk of injury! Aggressive vapours may be generated during the aspiration of liquids. Use appropriate smoke filter for the aspiration of liquids with highly volatile agents (e.g. when using iodine as disinfectant). CAUTION! Property damage due to oversuction! The product may only be operated with the overflow protection in place as otherwise oversuction could occur.
- Page 21 Safety notes Product safety notes CAUTION! Property damage due to material failure! Do not exceed the permissible overall load of 8 kg of each of the equipment rails of the trolley. CAUTION! ATMOS recommends always having an alternative suction option ready. This way you can perform aspiration even in the event of product failure.
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Page 22: Initial Operation
Initial operation General Initial operation General WARNING! Infection hazard! Contaminated components may endanger the health of staff and patients. Ensure the product is prepared as per hygiene standards before using it for the first time. NOTE Various septic fluid jar caps may be used. Refer to the respective manufacturer's instructions for information on the mounting procedure. -
Page 23: Aspirator On Trolley
Initial operation Variations in use 3.2.2 Aspirator on trolley A trolley is available to make it easier to transport the aspirator and to mount additional accessories. Locking the castor brakes Lock the brakes (2) of the castors on the trolley (1). -
Page 24: Inserting The Catheter Holder (Ref 5750 8002)
Initial operation Variations in use 3.2.2.1 Inserting the catheter holder (REF 5750 8002) NOTE The catheter holder can only be mounted if the aspirator is not mounted on the trolley. To secure the catheter holder, remove the aspirator from the trolley. ... -
Page 25: Overflow Protection Device
Initial operation Overflow protection device Overflow protection device NOTE If the float is not correctly seated in the overflow protection device, or no float is used, liquid may exit in the event of oversuction. NOTE It is not necessary to use a hydrophobic bacterial and viral filter if a hydrophobic bacterial and viral filter is integrated in the septic fluid jar of a disposable extraction system. -
Page 26: Mounting The Hydrophobic Bacterial And Viral Filter
Initial operation Overflow protection device 3.3.1.1 Mounting the hydrophobic bacterial and viral filter NOTE When mounting the aspirator to an equipment rail, attach a tube with an 8 mm inner diameter (e.g. REF 5750 5483) using the tube adapter (REF 5752 2295) between the hydrophobic bacterial and viral filter (1) and the opening (2) on the back of the aspirator in order to prevent the hydrophobic filter from colliding with the wall / equipment rail. -
Page 27: Mounting Septic Fluid Jar Caps With Integrated Overflow Protection
Initial operation Rail clamp mounting point 3.3.3 Mounting septic fluid jar caps with integrated overflow protection NOTE When mounting the aspirator to an equipment rail, attach a tube with an 8 mm internal diameter (e.g. REF 5750 5483) using the tube adapter (REF 5752 2295) between the hydrophobic bacterial and viral filter (1) and the opening (2) on the back of the aspirator in order to prevent the hydrophobic filter from colliding with the wall/equipment rail. -
Page 28: Equipment Mount Interface
Initial operation Equipment mount interface Mounting the switch valve Attaching rail clamp [ Page 27]. Attach equipment mount (1) of switch valve to rail clamp (2). Fig. 13: Attaching the vacuum shift Equipment mount interface CAUTION! Property damage due to material failure! Do not exceed the permissible overall load of 2 kg at the equipment mount interface. -
Page 29: Mounting The Septic Fluid Jar
Initial operation Mounting the tubes 3.5.1 Mounting the septic fluid jar Mounting of the tubes is described using the septic fluid jar (REF 5752 5431) as an example. Removing the cap Pull off cap (1) upwards. Connection of equipment mount is ready for use. -
Page 30: Tube Connections Of Universal Overflow Protection
Initial operation Mounting the tubes 3.6.1 Tube connections of universal overflow protection Attach the connection tube (1) to the hydrophobic filter (3). Attach the other end of the connection tube (1) to the universal overflow protection device (2). Fig. -
Page 31: Tube Connection Of Overflow Protection Device With Septic Fluid Jar Cap (Ref 5750 0390)
Initial operation Mounting the tubes 3.6.3 Tube connection of overflow protection device with septic fluid jar cap (REF 5750 0390) Mounting is described using the surgical overflow protection as an example. Attach connection tube (1) to overflow protection device (2). ... -
Page 32: Tube Connection For Vacuum Shift (Ref 5752 2049)
Initial operation Mounting the tubes 3.6.5 Tube connection for vacuum shift (REF 5752 2049) The mounting of the tubes is described using the septic fluid jar cap (REF 5750 5362) as an example. Connect the connection tube (1) to the lower adapter (2) of the vacuum shift. -
Page 33: Foot Switch (Only For Bora Up 2080 Op)
Initial operation Foot switch (only for BORA UP 2080 OP) Foot switch (only for BORA UP 2080 OP) Attaching the foot switch Insert the tube (1) of the foot switch into the opening (2) on the rear of the device. ... -
Page 34: Operation
Operation Functional test Operation Functional test NOTE Connecting several septic fluid jars in series can cause delayed suction effect and reduced suction power. Prior to each use, carry out the following functionality checks: • All components are properly attached. • The mains cable is undamaged. •... -
Page 35: Switching On The Aspirator
Operation Suction NOTE In the event that the overflow protection device has been tripped, switch off the aspirator. Empty and clean or replace all parts. NOTE Replace the hydrophobic bacterial and viral filter immediately if it is discoloured, contaminated or oversucked. Furthermore, the filter must be exchanged if the vacuum displayed is above −0.3 bar / 30 kPa when the vacuum controller is in the ‘max’... -
Page 36: Operating The Foot Switch (Only For Bora Up 2080 Op)
Operation Suction Setting the vacuum level Kink the suction tube on the patient side and hold it closed. Set the vacuum with the regulating knob (1) and check. Increasing vacuum Turn the regulator knob (1) to the right. ... -
Page 37: Setting The Vacuum Shift
Operation Utensil 4.2.4 Setting the vacuum shift The vacuum shift can be set in four different ways • Pfeil (1) auf dem Drehschalter (2) des Umschaltventils zeigt nach rechts: Absauggut wird in rechten Sekretbehälter gesaugt. • Pfeil (1) auf dem Drehschalter (2) des Umschaltventils zeigt nach links: Absauggut wird in linken Sekretbehälter gesaugt. -
Page 38: Replacing The Bacterial Filter Paper
Operation Replacing the bacterial filter paper Replacing the bacterial filter paper WARNING! Infection hazard! Any and all the parts of the product could be contaminated. Wear gloves and be absolutely sure to follow the hygiene rules during all cleaning and reconditioning work. NOTE Using the aspirator requires daily replacement of the bacterial filter paper. -
Page 39: Taking The Unit Out Of Operation
Taking the unit out of operation Completing the aspiration process Taking the unit out of operation Completing the aspiration process Remove the tube from the patient. Switch off the aspirator. Empty the septic fluid jar. Clean the components. Emptying the septic fluid jar DANGER! Infection hazard! -
Page 40: Disassembly
Taking the unit out of operation Disassembly Disassembly 5.3.1 Detaching tubes The disassembly of the tubes is described using the septic fluid jar cap (REF 5750 5362) as an example. Switch off the aspirator. Remove the connection tube (1) from the black connection of the septic fluid jar cap. - Page 41 Taking the unit out of operation Disassembly Surgical overflow protection Remove the lid (1) from filter housing by lifting upwards. Remove the bacterial filter (2). Unscrew the lid of the overflow protection device (3). Detach float cage (4) and remove the float (5).
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Page 42: Cleaning And Disinfection
Cleaning and disinfection General Cleaning and disinfection General All the components in the aspirator which come into contact with septic fluid must be cleaned and disinfected after each use. DANGER! Danger to life! Electric shock! Remove the mains plug from the socket before cleaning / disinfection. DANGER! Danger to life! Electric shock! -
Page 43: Cleaning
Cleaning and disinfection Cleaning CAUTION! Improper cleaning and disinfection can cause property damage! Use only as much detergent and disinfectant as required. CAUTION! Improper cleaning and disinfection can cause property damage! Perform visual and functional inspections after each cleaning and disinfection process. -
Page 44: Cleaning Procedure
Cleaning and disinfection Disinfection CAUTION! Improper cleaning can cause property damage! Do not spray cleaning agent directly into the joints or gaps and never use a high- pressure cleaning unit! 6.2.2 Cleaning procedure Use the correct dose of multi-purpose detergent with water for the degree of surface contamination and in accordance with the instructions of the detergent manufacturer. -
Page 45: Disinfection Procedure
Cleaning and disinfection Disinfection Ingredient group Active ingredients Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal, o-phthaldialdehyde, succinaldehyde Quaternary ammonium Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl- compounds alkylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride, benzalkonium propionate, benzalkonium chloride (alkyl-dimethyl- benzyl ammonium chloride, coco-dimethyl-benzyl ammonium chloride, lauryl-dimethylbenzyl ammonium chloride, myristyl- dimethyl-benzyl ammonium chloride), benzethonium chloride, benzyl-dihydroxyethyl-coco-alkyl ammonium chloride, dialkyl-... - Page 46 Cleaning and disinfection Disinfection Components In solution Wipe, spray disinfection Aspirator basic equipment Trolley Catheter holder Mains cable Foot switch Cap to cover the Only spray disinfection equipment mount interface Bacterial filter cap Float / float cage Suction tube / connection tube Tube adapter Housing of overflow...
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Page 47: Maintenance
Maintenance General Maintenance General Maintenance, repairs and period 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 48 Maintenance Malfunctions and troubleshooting Malfunction Cause Remedy Aspirator does not start Equipment or mains plug is Check the equipment and operation, operating status not seated properly in the mains plugs for proper display is not illuminated. socket. contact. None or improper voltage. Check the building fuse, check the specifications on the type plate.
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Page 49: Replace Mains Fuse
Maintenance Malfunctions and troubleshooting Malfunction Cause Remedy Suction tip is clogged. Clean suction tip. The motor is defective. Have the equipment repaired by a service technician authorised by ATMOS. Aspirator has been exposed No mechanical overflow Aspirator may no longer be to oversuction. -
Page 50: Repairs
Maintenance Repairs Remove the fuse carriers (1). Remove the fuses (2) from the fuse carriers. Insert new fuses. Insert fuse holders and screw closed. Fig. 34: Replacing fuses Repairs The following issues may require repairs by the manufacturer or an authorised service partner: •... -
Page 51: Type Plate Position
Maintenance Type plate position Type plate position Position of the type plate (1) on the product. Fig. 35: Type plate Service hotline: +49 7653 689-0 Spare parts 5752 4982 Foot switch 5752 3082 Repair set, bacterial filter cap 5750 5384 Regulating knob 5750 3609 Mains cable 4.0 m... -
Page 52: Technical Specifications
Technical specifications General Technical specifications General Klassifizierung nach Anhang IX der Richtlinie Class IIa 93/42/EWG Type of protection against electric shock Class I (IEC 60601-1) Level of protection against electrical shock Type BF* (IEC 60601-1) Protection against ingress of liquids IP X1 (IEC 60601-1) Accuracy class of vacuum gauge Year of manufacture... -
Page 53: Weight
Technical specifications Weight Aspirator, mobile 550 x 570 x 1080 mm Mains cable 4000 mm Weight Aspirator basic equipment ca. 11 kg Trolley Approx. 9.6 kg Aspirator, mobile ca. 20.6 kg Vacuum depending on altitude Altitude Final pump vacuum Final pump vacuum 2000 m -68 kPa −510 mmHg... -
Page 54: Resistance To Electromagnetic Interference
Technical specifications Electromagnetic compatibility (EMC) 8.7.2 Resistance to electromagnetic interference Measurement / Test level Compliance level Electromagnetic Envi- Standard ronment / Guidelines Electrostatic dis- ± 6 kV Contact ± 6 kV Contact Floors should be made of charge (ESD) discharge discharge wood or concrete or cov- ered with ceramic tiles. -
Page 55: Resistance To Electromagnetic Interference, Non-Life-Sustaining Equipment
Technical specifications Electromagnetic compatibility (EMC) 8.7.3 Resistance to electromagnetic interference, non-life-sustaining equipment Measurement / Test level Compliance lev- Electromagnetic Environment / Standard Guidelines Conducted HF in- Portable and mobile RF communica- terference as per tion equipment should be used no 150 kHz to 150 kHz to IEC 61000-4-6... -
Page 56: Recommended Separation Distances
Technical specifications Electromagnetic compatibility (EMC) 8.7.4 Recommended separation distances The following is a table showing the recommended separation distance between portable and mobile RF telecommunication equipment and the product. The product is engineered for use in an electromagnetic environment in which RF interference is monitored and controlled. -
Page 57: 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 2391 Overflow protection device with equipment mount and jar PSU 5752 2392 Overflow protection device with chamber for hydrophobic bacterial and virus filter 5752 4514 Hydrophobic filter (for AS universal overflow protection) -
Page 58: Bora Up 2080
Approved accessories BORA UP 2080 5752 2295 Tube adapter Tab. 12: Accessories BORA UP 2080 5752 4856 BORA UP 2080 complete unit / septic fluid aspiration / portable / 1 x 1 l 5752 5511 BORA UP 2080 complete unit / septic fluid aspiration / mobile / 1 x 3 l 5752 5512 BORA UP 2080 OP complete unit / surgical aspiration / mobile / 2 x 3 l 5752 5673... - Page 59 Notes...
- Page 60 Hersteller: ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch DEUTSCHLAND Telefon: +49 7653 689-0 www.atmosmed.com...
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