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Medela Basic, Инструкция по эксплуатации

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EN

Installation

  |  13

Check initial delivery

5  Installation

Check the delivery package of the Basic for completeness 
and general condition.

Basic portable version

071.0000

Basic rack version

071.0001

Mains plug

See service manual

Safety Set

077.0711

Silicone Tubing  ø 7 x 12 mm  with   

2 coupling pieces

077.0922

Instructions for use

Basic

SURG

ICAL S

UCTION

 PUMP

EN

  Instructions for use

DE

  Gebrauchsanweisung

FR

  Mode d’emploi

IT

  Istruzioni per l’uso

NL

  Gebruiksaanwijzing

SV

  Bruksanvisning

FI

  Käyttöohjeet

NO

  Bruksanvisning

ES

  Instrucciones de uso

PT

  Instruções de utilização

200.5524

or

5.1

Содержание Basic

Страница 1: ...Basic SURGICAL SUCTION PUMP EN Instructions for use ...

Страница 2: ...ion 13 Check initial delivery 13 Remove transport lock 14 Set up mobile version if available 14 Assembly of the optional clampholder 14 Set up the Safety Set 14 6 Preparation for use 15 Checks before use 15 Assembly of the basic configuration 15 Assembly of the optional foot switch 16 Assembly of the REUSABLE collection system 16 Assembly of the DISPOSABLE collection system 17 Install equipotentia...

Страница 3: ...test 26 14 Cleaning guidelines 27 General notes 27 Medela recommended surface cleaning agents for pump housing 27 Water 27 Cleaning disinfection machines 27 Disposable products 27 15 Warranty and servicing 29 Warranty 29 Servicing Routine check 29 16 Disposal 29 17 Accessories overview 30 18 Technical specifications 31 19 Signs and symbols 32 I Technical documentation EMC 326 II List of accessorie...

Страница 4: ...ction pumps this pump provides reliable and simple suction Its simple handling and cleaning as well as the safety features are additional advantages you receive A comprehensive range of accessories makes the Basic ideally suited to a wide range of medical applications and can be used for continuous operation Contact us we will be pleased to advise you ...

Страница 5: ...of the device and may not be operated in combination with the Basic pump Please read and observe these warning and safety instructions before operation These Instructions for Use must be kept with the device for later reference Please note that these instructions for use are a general guide for the use of the product Medical matters must be addressed by a physician Medela is only responsible for t...

Страница 6: ...e for thoracic drainage without specialized accessories Not approved for outdoor use or transport applications The Basic pump may shortly shut down with electrostatic discharge ESD events at the DC port of 15kV CAUTIONS Incorrect use can cause pain and injury to the patient Do not use sterile accessories when the sterile packaging is damaged Wireless communications equipment such as wireless home ...

Страница 7: ...e life in accordance with the service manual The protection of the Medela Basic against the effects of the discharge of a cardiac defibrillator is dependent upon the use of appropriate cables Separation from the mains is only assured through the disconnection of the mains plug and the fixed mains socket Before you plug in the device please check that your local power supply is the same as the volt...

Страница 8: ...wer supply cord away from hot surfaces The mains plug must not come into contact with moisture Never pull the mains plug out of the fixed mains socket by pulling on the power supply cord Never leave the device unattended when it is switched on The pump must stand upright during use Never use the device at high room temperatures while bathing or showering if you are very tired or in an environment ...

Страница 9: ... in the device please check that your local power supply is the same as the voltage given on the specification plate Plugging in the pump Take the power supply cord and plug into the appliance inlet port at the back of the device Use the mounting bracket to secure the cord in the inlet port ...

Страница 10: ...a constant vacuum in the range of 0 to 90 kPa This vacuum can be used for all applications in the hospital clinic and doctors practice which require a vacuum in this setting such as general surgery liposuction endos copy epicardial ablation nasopharyngeal suction neurosurgery OPCAB vacuum assisted cesarian delivery and wound drainage Intended user The Basic should only be operated by properly trai...

Страница 11: ...pascal kPa In this document the indication of 10 kPa for example always refers to a pressure range in kPa below atmospheric ambient pressure according to EN ISO 10079 1999 Vacuum gauge Vacuum regulator On off button Safety Set Handle with two holders for jars Standard rail Mobile trolley optional accessory Foot on off switch trolley All castors with brakes Portable version Rack version Versions an...

Страница 12: ...ents and indicators green light Pump is plugged in yellow light Pump has an error Refer to chapter 11 white light Pump is running Jar Cable holder with optional trolley Back of device Medela 077 0723 Port for optional foot on off switch Fuses Appliance inlet Equipotential conductor activated deactivated ready for use ...

Страница 13: ...0001 Mains plug See service manual Safety Set 077 0711 Silicone Tubing ø 7 x 12 mm with 2 coupling pieces 077 0922 Instructions for use Basic SURGICAL SUCTION PUMP EN Instructions for use DE Gebrauchsanweisung FR Mode d em ploi IT Istruzioni per l uso NL Gebruiksaanwijzing SV Bruksanvisning FI Käyttöohjeet NO Bruksanvisning ES Instrucciones de uso PT Instruções de utilização 200 5524 or 5 1 ...

Страница 14: ...Set up mobile version if available 1 1 1 Position top part of trolley on bottom part making sure the tubing fits as shown 1 2 Connect parts with 4 screws 5 3 Assembly of the optional clampholder when using the trolley 1 1 1 Press and hold the blue release knob 1 2 Attach the clampholder to the standard rail by releasing the blue knob 5 4 Set up the Safety Set 1 1 1 Attach the mechanical overflow p...

Страница 15: ...lter if required to the Safety Set with the arrow pointing in the flow direction 3 Attach all necessary accessories according to your needs See annex II List of accessories Checks before use Check the Basic system before use for damage of the power cord or plug obvious device damage or safety defects and proper functioning of the device Check for completeness and general condition of the Basic del...

Страница 16: ...1 Attach mechanical overflow protection to lid 2 2 Pull gently downwards to make sure it is open deactivated 2 1 2 2 4 4 1 Connect tubing from the Safety Set to the lid of the jar vacuum port 5 5 1 Connect patient tubing to the lid of the jar patient port Assembly of the optional foot switch 1 1 1 Connect the optional foot switch to the pump by plugging in the plug 1 2 Test the correct function ni...

Страница 17: ...ng to instructions delivered with liners The disposable liner has an integrated overflow pro tection filter No action is necessary to activate it 5 1 Connect patient tubing to the lid of the liner using either the coloured angle piece or the patient port directly depending on tubing size Install equipotential bonding 1 1 1 Connect the equipotential conductor at the back of the Basic with the bus b...

Страница 18: ...00m 85kPa 638mmHg 0m 90kPa 675mmHg Check maximal vacuum for functional check 1 1 1 Switch on the Basic 2 2 1 Turn the vacuum regulator to the right to set maximum vacuum Altitude above sea level Specifications Max Vacuum Connect Basic to mains power 2 1 Connect the power cord to the appliance inlet at the back of the Basic 2 2 Plug in the mains plug of the power cord to a fixed mains socket 2 3 3 ...

Страница 19: ...damage Changing vacuum level 1 1 1 Clamp patient tubing 1 2 Turn vacuum regulator to select the correct vacuum according to the particular application 1 3 Check vacuum gauge for setting Placing out of operation after use 1 1 1 Touch on off button to switch off the Basic 2 2 1 Disconnect the mains plug from the fixed mains socket 3 Clean and disinfect the Basic See chapter 14 7 3 7 4 ...

Страница 20: ...ttach tubing from suction cup to patient connection on the lid of the liner 3b 3 1 Attach tubing from suction cup to patient connector on suction jar of the reus able collection system or 2 2 1 Connect the foot vacuum regulator the silver adapter must be fully seated in the Safety Set of the suction pump 2 2 Attach tubing to top of metal adapter 5 5 1 If OK release vacuum by returning foot vacuum ...

Страница 21: ...ure new jar in the clampholder or directly to the Basic carrying handle 2 3 Reconnect vacuum tubing and new patient tubing firmly 1 1 1 Switch pump off by touching the on off button 1 2 Remove patient and vacuum tubings from the lid 1 3 Remove full jar from the Basic 4 4 1 Switch pump on by touching the on off button Vacuum is built up 4 2 Set vacuum according to the particular application See cha...

Страница 22: ...ological characteristics 1 1 1 Remove patient tubing with coloured angle piece from lid 1 2 Plug patient port 1 5 l 2 5 l 5 Dispose of the liner and patient tubing in accordance with local guidelines and inhouse guidelines 3 3 1 Reduce vacuum to mini mum by turning vacuum regulator to the left 2 2 1 Switch pump off by touch ing the on off button 4 4 2 Remove full liner from the jar ...

Страница 23: ...ton Vacuum is built up 8 2 Set vacuum according to the particular application See chapter 7 3 6 6 1 Prepare new liner and unpack it 6 2 Insert new liner in the jar and press down lid 7 7 1 Connect tubing from the jar to the Safety Set 7 2 Connect new patient tub ing firmly 7 2 7 1 ...

Страница 24: ...n is activated deactivate it as shown under 6 4a 2 2 the suction jar lid have no cracks brittle areas discolouration If necessary replace the disposable system has no cracks brittle areas discolouration If necessary replace the filter is not clogged To test if the filter is clogged see chapter 13 If the fault cannot be rectified please contact the internal technical department No LED lit The Basic...

Страница 25: ...WARNINGS Before replacing the fuse pull the mains plug from Basic out of the fixed mains socket 4 4 1 Close push back the fuse holder 1 1 1 Disconnect the Basic from the mains 1 2 If attached remove the cable holder 2 screws on bottom 2 2 1 Open pull out the fuse holder on the back of the Basic 5 5 1 Reconnect the Basic to the mains again 5 2 Switch on the Basic again ...

Страница 26: ...er test 13 Filter test 4 4 1 Read the vacuum 4 2 Replace the filter if the vacuum exceeds 20kPa 2 2 1 Select maximum vacuum 1 1 1 Remove tubing from filter 3 3 1 Switch on Basic by press ing the on off button ...

Страница 27: ... to reduce this problem The final rinse water should be bacterial free and contains no endotoxins Medela recommended surface cleaning agents for pump housing Perform concentrate Schülke Mayr www schuelkemayr com Cleaning disinfection machines Can be used to desinfect parts from the table on the next page A hot water rinse maximum temperature 100 C may provide a medium to high level of disinfection...

Страница 28: ...rt and repeat these steps if necessary x x 3 Cleaning Wipe with detergent mentioned above Use clean cloth to dry x x x x x 4 Disinfect Soak at room temperature for 30minutes in a disinfection cleaning solution A After the reaction time use water to rinse the solution residue from the individual parts and rinse the tubing Rinse for at least 2minutes with the cleaning solution B A fluid aldehyde fre...

Страница 29: ...ne check Routine checks and service work are only to be carried out by positions authorised by Medela Medela recommends to carry out the routine check 1x per year see service manual The Medela service manual is available upon request 16 Disposal The Basic is made of metals and plastics and should be disposed of in accordance with the European directives 2011 65 EU and 2012 19 EU Additional local g...

Страница 30: ... 14mm Tubing connection on disposable liners Ø6 5 11mm Note when combining Medela parts and a new patient interfacing device you take over the responsibility of the entire system and should test the combination to ensure the vacuum levels are properly maintained 17 Accessories overview WARNINGS Basic was verified in combination with the accessories listed in annex II List of accesso ries For corre...

Страница 31: ...on 18 Technical specifications 100 240 V 50 60 Hz 50 W AC ISO 9001 ISO 13485 CE 93 42 EEC IIa high vacuum 90kPa 675mmHg Tolerance 15 Measured at 0 m atmospheric pressure 1013 25 hPa Please note vacuum levels may vary depending on location meters above sea level atmospheric pressure and temperature Transport Storage Conditions Operating Conditions IP21 ...

Страница 32: ... ductor connection This symbol indicates the class of the pump This symbol indicates the legal specifica tions of the pump This symbol indi cates a CAUTION or WARNING associated with the device This symbol indicates protective earth ground This symbol indicates the device is sterilized using ethylene oxide This symbol indicates manufacturer s catalogue number This symbol indicates manufacturer s s...

Страница 33: ...he pump This symbol indicates the flow levels of the pump This symbol indicates the weight of the pump This symbol indicates the electrical specifi cations of the pump This symbol indicates to not dispose the device together with unsorted municipal waste for EU only This symbol indicates do not use the device if package is dam aged This symbol indicates to keep the device dry This symbol indicates...

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