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Related Manuals for MEDAP TWISTA SP 1070
Summary of Contents for MEDAP TWISTA SP 1070
- Page 1 OPERATING INSTRUCTIONS SURGICAL ASPIRATOR MEDAP-TWISTA SP 1070 GA 5752 1555 GB 30...
- 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. V30 2024-06 GA 5752 1555 GB 30...
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Page 3: Table Of Contents
ATMOS products ....................... 9 1.2.7 Used electrical devices ........................ 9 Overview ..............................10 1.3.1 Overview of TWISTA SP 1070 ....................10 Basic requirements ........................... 11 1.4.1 Use in accordance with the intended purpose ................11 1.4.2 Applicable standards ........................11 1.4.3... - Page 4 Table of contents Initial operation ............................20 General ..............................20 Scope of delivery ............................20 Mounting the stand ........................... 21 Mounting the tube holder.......................... 24 Mounting the foot switch ........................... 24 Overflow protection device/tube connector ....................24 3.6.1 Mounting the mechanical overflow protection device (REF HM57521775) ....... 25 3.6.1.1 Inserting the overflow protection device ..............
- Page 5 Sending in the device ..........................50 Technical specifications ........................51 Device ..............................51 Approved accessories ........................... 53 Accessories .............................. 53 TWISTA SP 1070 ............................. 54 Application sets ............................54 Consumables ............................54 Notes on EMC ............................55 GA 5752 1555 GB 30...
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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 Identification Symbols Date of manufacture Country of manufacture: Germany Reference number Unique Device Identifier of a medical device Medical device Serial number Specification of the degree of protection against the ingress of solids and moisture Symbol for foot switch —>...
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Page 9: Udi Code
Introduction How to use these operating instructions 1.2.5 UDI code UDI-DI: Identification of the manufacturer and the device (01) Date of manufacture (11) Packing date (13) Serial number (21) Tab. 4: UDI code 1.2.6 Disposal 1.2.6.1 Packing The packing is made of materials compatible with the environment. ATMOS will dispose of the packing materials upon request. -
Page 10: Overview
Introduction Overview Overview 1.3.1 Overview of TWISTA SP 1070 Fig. 1: Overview of TWISTA SP 1070 1 Aspirator basic equipment 9 Push bar 2 Control panel 10 Tube holder 3 Vacuum gauge 11 Equipment rail 4 Control light foot switch... -
Page 11: Basic Requirements
Directive 93/42/EEC. 1.4.3 Intended purpose Product name: TWISTA SP 1070 Main functions: Aspiration of secretion, blood, serous fluids and rinsing fluids along with any contained particles and temporary collection of these fluids Intended use: Drainage and temporary collection of body fluids. -
Page 12: Versions
1.4.3.1 Versions These operating instructions apply to the versions listed below: TWISTA SP 1070 230 V; 50 Hz / 60 Hz (REF HM57521554) • Basic equipment • Mains cable • Foot switch •... -
Page 13: Interface Description
• Always fix septic fluid jars firmly and ensure safe connection to the equipment rail 25 x 10 mm of the TWISTA SP 1070. • The outer diameter of the tube connector on the patient side should match the inner diameter of the suction tube. -
Page 14: Suction Tube
Introduction Basic requirements 1.4.4.4 Suction tube The suction tube is used to connect the tube connector on the septic fluid jar cap on the patient side and the utensil. Technical specifications: • Shore hardness of 60 • Internal diameter of 6-8 mm •... -
Page 15: Equipotential Bonding Cable
Introduction Basic requirements 1.4.4.10 Equipotential bonding cable Equipotential bonding cable acts as the connection between the aspirator and the equipotential bonding pin with equipotential bonding rail for protection against electric shock. GA 5752 1555 GB 30... -
Page 16: Safety Notes
Safety notes General safety notes Safety notes General safety notes DANGER! Danger to life! Danger due to unauthorised modifications. The product may not be modified. DANGER! Explosion hazard! The product does not have explosion protection and is not approved for use in Class AP-M hazardous locations. - Page 17 Safety notes General safety notes DANGER! Danger to life! Electric shock resulting from an object being inserted from the outside into the case and its making contact with live components. Never insert any objects into the case. DANGER! Potentially fatal due to electrical shock! The product may only be connected to voltage supplies with protected earth connections.
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Page 18: Product Safety Notes
Safety notes Product safety notes WARNING! Tripping hazard due to cables! Injuries and fractures are possible. Lay connecting cables properly. Product safety notes DANGER! Infection hazard! Risk of bacteria and viruses entering the aspirator. A bacterial and viral filter protects the inside of the aspirator against contamination by bacteria and viruses. - Page 19 Safety notes Product safety notes CAUTION! Property damage! The aspirator may not be lifted or carried using the push bar. CAUTION! Property damage due to overheating! Ventilation slots on the rear side of the device. The ventilation slots must always remain open.
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Page 20: Initial Operation
Initial operation General Initial operation General WARNING! Risk of injury! ATMOS products may be used only when fully functional. Check to ensure that the ATMOS product is fully functional and in good working order prior to use. ATMOS recommends always having an alternative suction option ready. -
Page 21: Mounting The Stand
Initial operation Mounting the stand Mounting the stand CAUTION! Property damage! Improperly mounted stands cause danger of tipping over. Make sure that you have a right and a left stand and that the stands are mounted properly. Position for installation ... - Page 22 Initial operation Mounting the stand Mounting the first stand Place the red point of the stand (1) on the red point of the basic equipment (2). The longer part of the stand (3) must point to the floor. ...
- Page 23 Initial operation Mounting the stand Aligning and fixing stands Position the aspirator (1) on an even surface. The longer parts of the stand (2) are located on the front of the equipment. Stands are aligned. Hand tighten screws to maximum with Allen key (3).
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Page 24: Mounting The Tube Holder
Initial operation Mounting the tube holder Mounting the tube holder The tube holders are screwed into place on the right and left sides of the equipment rail. Press the tube holder (1) onto the device (2). Threaded hole (3) of the tube holder. ... -
Page 25: Mounting The Mechanical Overflow Protection Device (Ref Hm57521775)
Initial operation Overflow protection device/tube connector WARNING! Infection hazard due to oversuction! To protect the aspirator from oversuction, the aspirator may only be operated with the overflow protection in place. CAUTION! Property damage! If the float of the overflow protection device is not fitted properly or if it is not used, liquid may enter the aspirator and damage it. -
Page 26: Mounting The Hydrophobic Bacterial And Viral Filter (Ref Hm57521783) In The Mechanical Overflow Protection (Ref Hm57521775)
Initial operation Overflow protection device/tube connector 3.6.2 Mounting the hydrophobic bacterial and viral filter (REF HM57521783) in the mechanical overflow protection (REF HM57521775) The overflow protection device offers the possibility to subsequently connect a hydrophobic bacterial and viral filter to the mechanical overflow protection. It is required, if the aspirated gas contains aerosols. -
Page 27: Mounting Point For Rail Clamp (Ref Hm57522048)
Initial operation Mounting point for rail clamp (REF HM57522048) Insert the tube connector (1) into the opening (2) on the equipment. Fig. 13: Inserting the tube connector Mounting point for rail clamp (REF HM57522048) Containers with an equipment mount may be attached to the rail clamp mount. Attaching the rail clamp ... -
Page 28: Mounting The Vacuum Shift (Ref Hm57522049)
Initial operation Mounting the vacuum shift (REF HM57522049) Mounting the vacuum shift (REF HM57522049) The vacuum shift is used to switch between two septic fluid jars. Mounting the vacuum shift Attaching rail clamp [ Page 27]. Attach equipment mount (1) of vacuum shift to rail clamp (2). -
Page 29: Mounting The Tube To The Tube Connector Of The Atmos Disposable Suction System
Initial operation Mounting the tubes 3.9.1 Mounting the tube to the tube connector of the ATMOS disposable suction system Attach the connection tube (1) to the tube connector (2). Attach the free end of the connection tube (3) to the conical connection (4) of the hydrophobic bacterial and viral filter (5) (REF HM57524514). -
Page 30: Tube Connection Of Overflow Protection Device With Septic Fluid Jar Cap (Ref Hm57500390)
Initial operation Mounting the tubes 3.9.3 Tube connection of overflow protection device with septic fluid jar cap (REF HM57500390) Attach the connection tube (1) to the straight tube connector (2) of the cap plug. Attach the suction tube (3) to the second tube connector (4) of the cap plug. -
Page 31: Tube Connection Of Overflow Protection Device With Septic Fluid Jar Cap (Ref Hm57525432)
Initial operation Mounting the tubes 3.9.5 Tube connection of overflow protection device with septic fluid jar cap (REF HM57525432) Plug adapter (REF HM57522295) (1) onto the connection tube (2). Insert the adapter with the connection tube into the septic fluid jar cap (3). ... -
Page 32: Connecting/Disconnecting The Mains Cable
Initial operation Connecting/disconnecting the mains cable Attach the connection tube (4) to the left tube connector (5) of the vacuum shift. Attach the other end of the connection tube in the middle of the left septic fluid jar cap (6) (marked with "Vacuum"). - Page 33 Initial operation Connecting/disconnecting the mains cable Connecting the mains cable Check to ensure that the mains voltage is identical to the specifications given on the type plate (1). Plug the mains cable (2) into the equipment socket (3) and connect to the mains socket. Fig.
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Page 34: Operation
Operation Functional test Operation Functional test Prior to using the system, the operator should check that the product is fully functional and in good condition. 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 check: •... - Page 35 Operation Suction WARNING! Risk of infection due to using no or a defective hydrophobic bacterial and viral filter! Secretions enter the aspirator during aspiration. Stop using the aspirator. Clean and disinfect the aspirator and have it repaired by a service technician authorised by ATMOS to do so. WARNING! Backflow of aspirated secretion! In the event of oversuction, the aspirated secretion may flow back to the patient if...
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Page 36: Switching On The Aspirator
Operation Suction NOTE Rinse the suction tube briefly with clean water after each extraction cycle. 4.2.1 Switching on the aspirator Switch on the aspirator (1). The green power control light (2) is illuminated. Fig. 25: Switching on the aspirator 4.2.2 Setting the vacuum level NOTE... -
Page 37: Operating The Footswitch
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 38: Setting The Vacuum Shift
Operation Replacing the bacterial filter paper 4.2.4 Setting the vacuum shift The vacuum shift can be set in four different ways • Arrow (1) on the rotary switch (2) of the vacuum shift points to the right: Suction material will be conducted into the septic fluid jar on the right. -
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 HM57525655) as an example. Remove the suction tube (1) from the tube connector (2) on the patient side. ... -
Page 41: Cleaning And Disinfection
Cleaning and disinfection Cleaning Cleaning and disinfection Cleaning 6.1.1 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 42: General
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 43: Cleaning Procedure
Cleaning and disinfection Disinfection NOTE Use only all-purpose cleaners which are slightly alkaline (soap solution) and which contain surfactants and phosphates as the active cleaning agents. In the event of heavily contaminated surfaces, use concentrated multi-purpose detergent. 6.1.3 Cleaning procedure ... -
Page 44: Suitable Disinfectants
Cleaning and disinfection Disinfection 6.2.2 Suitable disinfectants Only surface disinfectants based on the following combinations of active ingredients may be used for disinfection: • Aldehydes • Quaternary compounds • Guanidine derivatives Ingredient group Active ingredients Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal, o-phthaldialdehyde, succinaldehyde Quaternary compounds Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl-... - Page 45 Cleaning and disinfection Disinfection Components In solution Wipe / spray disinfection Housing of overflow protection device Disposable Hydrophobic bacterial and viral filter (REF HM57521783) Bacterial filter paper When in use, must be replaced daily After exposure (as prescribed in the manufacturer's instructions), rinse components thoroughly with water and dry them afterwards.
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Page 46: 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 47: Malfunctions And Troubleshooting
Maintenance Malfunctions and troubleshooting Suggestion: Inspection Defects are present No defects Has the product been cleaned Do not use the product any and disinfected according to longer. the hygiene guideline? Clean and disinfect the product according to the guidelines. Comment: Are there cracks in the ... -
Page 48: Replace Mains Fuse
Maintenance Replace mains fuse No. Malfunction Cause Remedy Aspirator working but The vacuum gauge is Have the equipment repaired by vacuum gauge indicates defective. a service technician authorised no vacuum. by ATMOS. Reduced / no flow rate Septic fluid jar cap is not in Position septic fluid jar cap the correct position. -
Page 49: Repairs
Maintenance Repairs CAUTION! Property damage! You may only use fuses of the following type: • 2 x T 1.6 A H / 250 V for nominal voltage 230 V AC (REF HM57521554) • 2 x T 2.5 A H / 250 V for nominal voltage 127 V AC (REF HM57521559) ... -
Page 50: Type Plate
Maintenance Type plate Type plate Position of the type plate (1) on the product. Fig. 33: Type plate Spare parts Spare parts may be replaced by the end user. We will supply suitably trained and qualified staff with a complete list of spare parts on request. HM57524982 Foot switch HM57523082... -
Page 51: Technical Specifications
Technical specifications Device Technical specifications Device Input voltage 230 V~ ± 10%; 50/60 Hz Special voltage: 127 V~ ± 10 %; 60 Hz Current consumption max. 1.1 A (at 230 V~, 50/60 Hz) max. 1.6 A (at 127 V~, 60 Hz) Power consumption max. - Page 52 Technical specifications Device Environmental conditions: Operation • Temperature +15...+40 °C • Air humidity without condensation 30...75 % • Air pressure 700...1060 hPa Max. operating altitude (NN) 2,000 m Contamination level Overvoltage category Dimensions (H x W x D) 1000 mm x 500 mm x 560 mm Weight Approx.
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Page 53: Approved Accessories
Approved accessories Accessories Approved accessories Accessories HM5752 1775 Mechanical overflow protection device with chamber for hydrophobic bacterial and virus filter HM57505228 Septic fluid glass jar 5.0 I HM57505227 Septic fluid glass jar 2.5 I HM57505297 Septic fluid jar 3.0 I PSU HM57525656 Septic fluid jar, 4 l, PSU with equipment mount HM57525658... -
Page 54: Twista Sp 1070
TWISTA SP 1070 Application sets The TWISTA SP 1070 basic equipment must be fitted out with one of the following application sets (AS) as required for the intended use or application. Application sets can also be equipped with additional accessories according to individual requirements. -
Page 55: Notes On Emc
Notes on EMC Consumables Notes on EMC WARNING! Medical electrical equipment is subject to special precautions with regard to EMC and must be installed according to the following EMC notes. Guidance and manufacturer’s declaration – ambient conditions The product is suitable for use in the following environments: •... - Page 56 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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