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MEDAP WISTA SP 1070, Руководство по эксплуатации

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Introduction

Basic requirements

12

GA 5752 1555 DE 28

1

Contraindications:

The TWISTA SP 1070 may not be used for the following purposes:
•  Outside the medical sector
•  In the home care sector
•  Being operated directly by the patient
•  For vacuum extraction
•  For smoke evacuation
•  Without smoke evacuation filter, when aggressive vapours are 

also generated during the suction of liquids due to easily volatile 

components (e.g. when using iodine as disinfectant)

•  For the aspiration of flammable or explosive liquids
•  In areas prone to explosion risks (AP-M, APG areas)
•  For drainages in the low vacuum range (e.g. thoracic and wound 

drainage)

•  In the standard equipment version in heart surgery and in op-

erations on the central nervous system. This requires separate 

equipment providing reliable protection against equipotential 

bonding between the patient and contacting, fluid-filled metal 

parts.

The product is:

Active

Sterility:

No sterile product

Single-use product / 

reprocessing:

The device and parts of the accessories are reusable. For 

information on reprocessing, cleaning and disinfection, please see 

the operating instructions.

1.4.3.1 

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. The unit must be configured to 

be CF-proof in order to be used for cardiac or CNS applications.
The following guidelines are therefore imperative:
•  A hydrophobic bacterial filter must be fitted between the septic fluid jar and the pump inlet 

(REF 5752 1783).

•  All touchable components of the septic fluid jar must be made of non-conductive materi-

al (plastic), for example, cap plug (REF 5752 0184), Serres

®

 disposable suction liner 3 l 

(REF 310.0401.0) and Serres

®

 outer container 3 l (REF 310.0403.0).

•  Only CF-proof suction lances made of a plastic that does not conduct electricity may be used.
•  All other equipment parts and accessories must also be CF-proof.

1.4.4 

Versions

These operating instructions apply to the versions listed below:

TWISTA SP 1070 230 V; 50 Hz / 60 Hz (REF 5752 1554)

•  Basic equipment
•  Mains cable
•  Foot switch
•  Filter papers (10 pieces)
•  Allen key (REF 5750 4687)

Содержание WISTA SP 1070

Страница 1: ...OPERATING INSTRUCTIONS SURGICAL ASPIRATOR MEDAP TWISTA SP 1070 GA 5752 1555 DE 28...

Страница 2: ...1555 DE 28 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 V28 20...

Страница 3: ...s 11 1 4 1 Use in accordance with the intended purpose 11 1 4 2 Applicable standards 11 1 4 3 Intended purpose 11 1 4 3 1 For use in cardiac surgery and surgery of the central nervous system CNS 12 1...

Страница 4: ...of overflow protection device with septic fluid jar cap REF 5750 0390 29 3 9 4 Tube connection of overflow protection device with septic fluid jar cap REF 5750 5362 29 3 9 5 Tube connection of overflo...

Страница 5: ...ecifications 51 8 1 General 51 8 2 Ambient conditions 51 8 3 Technical specifications 51 8 3 1 TWISTA SP 1070 230 V 50 60 Hz 51 8 3 2 TWISTA SP 1070 127 V 60 Hz 52 8 4 Dimensions and weight 52 8 5 Vac...

Страница 6: ...nstructions carefully and completely before using the product for the first time Always proceed in accordance with the information contained herein Store these operating instructions in a location nea...

Страница 7: ...ersonal injury or property damage are structured as follows Pictogram Descriptor Reference to NOTE Supplementary assistance or further useful information without potential injury to persons or propert...

Страница 8: ...ective 2002 96 EC Directive on Waste Electrical and Electronic Equipment Symbol for Do not dispose of at the municipal collection points for used electrical equipment Labelling as per IEC 60529 standa...

Страница 9: ...ing materials upon request 1 2 5 2 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 1 2...

Страница 10: ...4 4 1 15 5 7 7 9 9 1 13 3 1 12 2 5 5 8 8 1 10 0 1 11 1 1 1 6 6 1 14 4 Fig 1 Overview of TWISTA SP 1070 1 Aspirator basic equipment 2 Control panel 3 Vacuum gauge 4 Control light foot switch 5 ON swit...

Страница 11: ...es and the Medical Products Act in Germany This has also been demonstrated through the application of the corresponding standards which have been harmonised with Directive 93 42 EEC 1 4 3 Intended pur...

Страница 12: ...ng The device and parts of the accessories are reusable For information on reprocessing cleaning and disinfection please see the operating instructions 1 4 3 1 For use in cardiac surgery and surgery o...

Страница 13: ...terial and viral filter with a pore size of 0 2 m Prerequisites Pore size 1 0 m Use a bacterial and viral filters suitable for the particular application The tube connector must match the tube being u...

Страница 14: ...Pa Prerequisites The suction tube must comply with the hospital s standards for hygiene The suction tube may not collapse The outer diameter of the tube connector on the patient side of the septic flu...

Страница 15: ...t be selected The interface descriptions for the aspirator must be observed 1 4 5 9 Switch valve The switch valve is used to switch between two septic fluid jars Prerequisites The tube connector must...

Страница 16: ...nd have it repaired by a service technician authorised by ATMOS to do so DANGER Danger to life For open heart operations and those to the central nervous system there may be equipotential bonding betw...

Страница 17: ...lectrical devices that may interfere with the functionality of the product in the vicinity of the product Observe the specifications in the technical data of the OR table with regard to electromagneti...

Страница 18: ...tects the inside of the aspiration from bacterial and viruses CAUTION Observe ambient conditions If the ambient conditions are undercut or exceeded during transportation storage or operation functiona...

Страница 19: ...tion device CAUTION Property damage due to material failure Do not exceed the permissible overall load of 10 kg of each of the equipment rails of the trolley NOTE Different septic fluid jar holders an...

Страница 20: ...erly 1 1 Fig 2 Assembly position Position for installation _ Remove stands installation material and accessories from the packing _ Place the basic equipment 1 on the ground with the top face down on...

Страница 21: ...equipment 2 9 The longer part of the stand 3 must point to the floor _ Screw in screw joints with Allen key 4 and tighten slightly 2 2 3 3 1 1 Fig 5 Securing the stands Mounting the second stand _ Pla...

Страница 22: ...stands Aligning and fixing stands _ Position the aspirator 1 on an even surface 9 The longer parts of the stand 2 are located on the front of the equipment 9 Stands are aligned _ Hand tighten screws t...

Страница 23: ...to the threaded holes _ Tighten tube holder using a screwdriver 3 5 Mounting the foot switch 1 2 3 Fig 9 Mounting the foot switch _ Insert the cable end 1 into the cap nut 2 _ Insert the cable end int...

Страница 24: ...low protection device REF 5752 1775 1 1 2 2 3 3 Fig 10 Mounting the overflow protection device Mounting the overflow protection device _ Engage float cage 1 with float into the lid 2 of the overflow p...

Страница 25: ...e mechanical overflow protection This gives rise to the risk of secretions entering and damaging the aspirator Always use a hydrophobic bacterial and viral filter and a commercially available foam inh...

Страница 26: ...sert the tube connector 1 into the opening 2 on the equipment 3 7 Mounting point for rail clamp REF 5752 2048 Containers with an equipment mount may be attached to the rail clamp mount 1 1 2 2 3 3 Fig...

Страница 27: ...switch valve to rail clamp 2 3 9 Mounting the tubes Mounting the tubes will be described in the following examples Tube connector 8 Page 28 Overflow protection device 8 Page 29 Tube connection of over...

Страница 28: ...e overflow protection device 1 1 2 2 Fig 16 Overflow protection device _ Attach the connection tube 1 to the tube connector 2 of the overflow protection device 3 9 2 Mounting the tube to the tube conn...

Страница 29: ...ht tube connector 2 of the cap plug _ Attach the suction tube 3 to the second tube connector 4 of the cap plug 3 9 4 Tube connection of overflow protection device with septic fluid jar cap REF 5750 53...

Страница 30: ...3 _ Attach the suction tube 4 to the patient side tube connector 5 on the septic fluid jar cap 3 9 6 Tube connection for vacuum shift REF 5752 2049 The mounting of the tubes is described using the se...

Страница 31: ...nection tube to the black tube connector 9 on the septic fluid jar cap 9 Vacuum shift is mounted 3 10 Connecting disconnecting the mains cable NOTE The plug must always be accessible to ensure that th...

Страница 32: ...cket Securing mains cable _ Secure the mains cable with the bracket 4 on the aspirator _ Connect the potential equalisation cable to the equalisation pin 5 Disconnecting the mains cable _ Pull the bra...

Страница 33: ...ination are present Tube connectors and septic fluid jar cap are tightly seated and do not leak No mechanical forces are acting on the tubes Tubes may not be kinked Maximum vacuum of approximately 90...

Страница 34: ...les in the gaseous phase may clog the hydrophobic filter Use a bacterial and viral filter which also protects the inside of the aspirator from bacteria and viruses CAUTION Property damage due to foami...

Страница 35: ...troubleshooting guide if there is insufficient vacuum or no vacuum at all 1 2 Fig 26 Setting the vacuum level Setting the vacuum level _ Kink the suction tube on the patient side and hold it closed Se...

Страница 36: ...f the vacuum shift points to the right Suction material will be conducted into the septic fluid jar on the right Arrow 1 on the rotary switch 2 of the vacuum shift points to the left Suction ma terial...

Страница 37: ...acement of the bacterial filter paper 1 1 2 2 Fig 29 Replacing the bacterial filter paper _ Screw off cap 1 _ Remove used bacterial filter paper 2 _ Clean and wipe disinfect the cap _ Insert new bacte...

Страница 38: ...r might be contaminated Always wear gloves when emptying the septic fluid jar and be absolutely sure to follow the hygiene rules CAUTION Property damage If the septic fluid jar is held by the septic f...

Страница 39: ...be 1 from the black connection of the septic fluid jar cap _ Remove the suction tube 2 from the light chromed tube connector on the patient side 5 3 2 Removing the overflow protection device NOTE Avoi...

Страница 40: ...lways wear gloves for cleaning and disinfection DANGER Infection hazard Particles of grime may become encapsulated and lead to the product not reaching the desired germ reduction after disinfection Be...

Страница 41: ...ue to tension cracks Acids or bases may cause tension cracks Do not treat polysulphone containers with strong acids or alkaline solutions NOTE To clean the operating foil rotate the regulation button...

Страница 42: ...t is free of detergent residues _ Dry the product with a dry absorbent and lint free cloth 9 This will help to reduce pathogen growth on the product s surface _ Wipe disinfect the product after every...

Страница 43: ...l ammonium chloride didecyl methyl oxyethyl ammonium propionate mecetronium ethyl sulfate methyl benzethonium chloride n octyl dimethyl benzyl ammonium chloride Guanidine derivatives Alkyl biguanide c...

Страница 44: ...ions rinse components thoroughly with water and dry them afterwards 2 After exposure as prescribed in the manufacturer s instructions remove disinfectant residues from the components using a moist clo...

Страница 45: ...to returning the aspirator for inspection or repair remove the bacterial and viral filter and all tubes and clean and disinfect the equipment 7 2 Period tests At least every 12 months a repeat test of...

Страница 46: ...s not start operation operating status display is not illuminated Aspirator is in standby mode Switch off standby mode using the foot switch The aspirator starts operating If the foot switch is operat...

Страница 47: ...icates vacuum Empty the septic fluid jar and clean or replace septic fluid jar and mechanical overflow protection Mechanical overflow protection is contaminated with exudate Clean overflow protection...

Страница 48: ...V AC REF 5752 1554 2 x T 2 5 A H 250 V for nominal voltage 127 V AC REF 5752 1559 1 1 1 1 Fig 32 Replacing fuses _ Disconnect equipment plug _ Unscrew fuse carriers 1 using a screwdriver or a coin 2...

Страница 49: ...REF number on the data plate and inform the responsible ATMOS Service Inform the appropriate foreign representative outside Germany Observe the information in chapter Sending in the device page 50 7...

Страница 50: ...he form QD 434 Delivery complaint return shipment and the respective decontamination certificate in a envelope This form is enclosed with each delivery and can be found at www atmosmed com _ The devic...

Страница 51: ...Ambient conditions Temperature Shipping storage 15 C to 50 C Temperature Operation 15 C to 40 C Relative humidity Transport storage 10 to 95 Relative humidity Operation 30 to 75 Atmospheric pressure S...

Страница 52: ...kPa 1 bar 1000 mbar 8 4 Dimensions and weight Length 560 mm Width 500 mm Altitude 1000 mm Weight Approximately 26 kg 8 5 Vacuum depending on altitude Altitude Final pump vacuum Final pump vacuum 2000...

Страница 53: ...a terial then the relative hu midity has to be at least 30 Electrical fast tran sient disturbances burst IEC 61000 4 4 2 kV for mains cables 1 kV for input and output cables 2 kV for mains cables 1 kV...

Страница 54: ...pment should be used no closer to the product incl cables than the recommended separation distance calculated using the equation for the particular transmission frequency Recommended separation distan...

Страница 55: ...unctioning properly If unexpected actions are found then additional measures may be required such as for example re orienting or relocating the product b The field strength should be less than 3 V m a...

Страница 56: ...ic and medical applications between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequenc...

Страница 57: ...5752 5657 Septic fluid jar cap 4 l PC 5750 0396 Cap plug 9 12 chrome plated 5752 0184 Cap plug 9 12 plastic 5750 3474 Equipotential bonding cable 5752 2048 Rail clamp for equipment mount metal 5752 25...

Страница 58: ...lso be considered Individual selection requires to comply with the interface description of the basic equipment NOTE A detailed description of the individual application set will be found in the curre...

Страница 59: ...Notes...

Страница 60: ...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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