Medela Basic Instructions For Use Manual

Medela Basic Instructions For Use Manual

Surgical suction pump

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Basic
SURGICAL SUCTION PUMP
Instructions for use
EN

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Summary of Contents for Medela Basic

  • Page 1 Basic SURGICAL SUCTION PUMP Instructions for use...
  • Page 2: Table Of Contents

    Set up the Safety Set ......................14 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 ..............
  • Page 3 Insufficient vacuum ........................ 24 12 Replacing defective fuse ....................25 13 Filter 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...
  • Page 4: Congratulations

    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.
  • Page 5: Warnings And Safety Instructions

    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 the effect on BASIC SAFETY, reliability and performance of the Basic if it is used in accordance with the Instructions for Use.
  • Page 6 – No modification of this equipment is allowed. – Consult the indications for use and consider risk factors and contraindications before using the Basic. Failure to read and follow all instructions in this manual prior to use may result in serious or fatal injury of the patient.
  • Page 7 – For safety tests, the device requires service and repair throughout its service 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.
  • Page 8: Safety Instructions

    Safety instructions – The Medela Basic is a medical device that requires special safety measures in regard to EMC. It must be installed and put into operation in accordance with the EMC infor- mation in annex “I Technical documentation (EMC).”...
  • Page 9: Power Supply

    2 Power supply The Basic is a mains-powered suction pump. Before you plug 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.
  • Page 10: Description

    Intended use / indications Intended Use of the Basic suction pump is the creation of 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...
  • Page 11: Overview

    4 Overview Definition of vacuum By the application of medical aspiration devices, vacuum is normally given as the difference (in absolute figures) between absolute pressure and atmospheric pressure or as negative val- ues in Kilopascal (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).
  • Page 12: Back Of Device

    Back of device Cable holder (with optional trolley) Port for optional foot on/off switch Fuses Medela 077.0723 Appliance inlet Equipotential conductor Operating elements and indicators On/off button green light Pump is plugged in Pump has an error. Refer to yellow light...
  • Page 13: Installation

    5 Installation Check initial delivery 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...
  • Page 14: Remove Transport Lock

    Remove transport 1.1 Remove the red note 1.2 Remove 3 screws and lock store them for later use. 1.1 Position top part of trolley Set up mobile version on bottom part, making (if available) sure the tubing fits as shown. 1.2 Connect parts with 4 screws.
  • Page 15: Preparation For Use

    Medela cleaning guide (product code 200.2391). 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 delivery package.
  • Page 16: Assembly Of The Optional Foot Switch

    Assembly of the 1.1 Connect the optional foot switch to the pump by optional foot switch plugging in the plug. 1.2 Test the correct function- ning of the foot switch. 6.4a Assembly of the 1. If you use a DISPOSABLE collection system proceed with step 6.4b REUSABLE collection system...
  • Page 17: Assembly Of The Disposable Collection System

    (depending on tubing size). Install equipotential 1.1 Connect the equipotential conductor at the back of bonding the Basic with the bus bar as advised by your techni- cian and according to to bus bar inhouse directives. The respective cable is not supplied from Medela.
  • Page 18: Operating Instructions

    7 Operating instructions CAUTIONS The Basic is to be set up in such a way, that a separation from the mains supply can be easily managed. Connect Basic to Check the pump before use following the instruction in chapter 6.1.
  • Page 19: Changing Vacuum Level

    CAUTIONS When the Basic is used for wound drainage, the negative pressure should be set according to instruction of the specialist and not cause any wound damage. Changing vacuum 1.1 Clamp patient tubing 1.2 Turn vacuum regulator to level select the correct vacuum according to the particular application.
  • Page 20: Vacuum Assisted Delivery Setup

    8 Vacuum Assisted Delivery setup CAUTIONS The Basic is to be set up in such a way, that a separation from the mains supply can be easily managed. 1. Set up pump and accessories according to chapter 6. 2.1 Connect the foot vacuum...
  • Page 21: Changing Reusable Jar

    2.1 Prepare new jar and unpack it. 2.2 Secure new jar in the clampholder or directly to the Basic carrying handle. 2.3 Reconnect vacuum tubing and new patient tubing firmly. 3. Empty jar and dispose of patient tubing according in accordance with local guidelines and inhouse guidelines.
  • Page 22: Changing Disposable Liner

    10 Changing disposable liner WARNINGS Disposable liners are not intended to be reprocessed. Reprocessing could cause loss of mechanical, chemical and / or biological characteristics. 1.1 Remove patient tubing with coloured angle piece from lid. 1.2 Plug patient port. 1.5 l 2.5 l 2.1 Switch pump off by touch- ing the on/off button.
  • Page 23 6.1 Prepare new liner and unpack it. 6.2 Insert new liner in the jar and press down lid. 7.1 Connect tubing from the jar to the Safety Set. 7.2 Connect new patient tub- ing firmly. 8.1 Switch pump on by touch- ing the on/off button.
  • Page 24: Troubleshooting

    – the Basic is switched on. The standby LED must be illuminated. – the mains plug is inserted correctly into the fixed mains socket and into the appliance inlet. – the fuse on the back of the Basic is not defective. For replacing the defective fuse see chapter 12.
  • Page 25: Replacing Defective Fuse

    12 Replacing defective fuse WARNINGS Before replacing the fuse, pull the mains plug from Basic out of the fixed mains socket. 1.1 Disconnect the Basic from the mains. 1.2 If attached, remove the cable holder (2 screws on bottom). 2.1 Open (pull out) the fuse holder on the back of the Basic.
  • Page 26: Filter Test

    13 Filter test 1.1 Remove tubing from filter. 2.1 Select maximum vacuum. 3.1 Switch on Basic by press- ing the on/off button. 4.1 Read the vacuum. 4.2 Replace the filter if the vacuum exceeds - 20 kPa. 26 | Filter test...
  • Page 27: Cleaning Guidelines

    – These are general recommendations only that may be adjusted individually, based on the hospital’s specific directives and cleaning practices and policies. – Also refer to detailed information according to Medela cleaning instructions (product code 200.2391). – Wear protective gloves for cleaning/disinfection.
  • Page 28 Legend: * Polysulfone ** Polycarbonate 1. Disassembly Separate all individual parts before cleaning, disinfecting and steri- lising. 2. Cleaning Clean components in hot water (60–70 °C) containing a detergent with a pH range between 6.0 and 8.0 only, in order to avoid dam- aging the instruments and containment devices.
  • Page 29: Warranty And Servicing

    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 guidelines must also be observed.
  • Page 30: Accessories Overview

    17 Accessories overview WARNINGS Basic was verified in combination with the accessories listed in annex “II List of accesso- ries”. For correct and safe operation, use Basic with these accessories only. Further infor- mation is supplied on the instruction sheet of the individual accessory.
  • Page 31: Technical Specifications

    18 Technical specifications high vacuum Measured at 0 m, atmospheric - 90 kPa / - 675 mmHg pressure: 1013.25 hPa Please Tolerance: +/- 15 % note: vacuum levels may vary depending on location (meters above sea level, atmospheric pressure and temperature). high flow 30 l/min.
  • Page 32: Signs And Symbols

    19 Signs and symbols This symbol This symbol indicates This symbol indicates indicates the the class of the pump. the date of manufac- compliance with ture. the essential requirements This symbol indicates This symbol indicates of the Council protective earth that the device should Directive 93/42/ (ground).
  • Page 33 This symbol indicates This symbol indicates This symbol indicates the humidity limitation to handle the fragile the fuse for operation, trans- device with care. port and storage. This symbol indicates This symbol indicates to keep the device the atmospheric dry. pressure limitation for operation, transport This symbol indicates...

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