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Basic
Service manual
13 pgs640.22 Kb0
User manual
33 pgs1.09 Mb0

Medela Basic User manual

Basic
SURGICAL SUCTION PUMP
EN
Instructions for use
Table of Contents
Congratulations ............................................................................................................................4
1 Warnings and safety instructions .......................................................................................5
Safety instructions ................................................................................................................... 8
2 Power supply .........................................................................................................................9
Plugging in the pump ..............................................................................................................9
3 Description ...........................................................................................................................10
4 Overview .............................................................................................................................. 11
Definition of vacuum .............................................................................................................. 11
Versions and main elements of the pump ............................................................................ 11
Back of device ....................................................................................................................... 12
Operating elements and indicators ........................................................................................12
Safety Set .............................................................................................................................. 12
5 Installation ............................................................................................................................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 equipotential bonding .................................................................................................17
7 Operating instructions ........................................................................................................ 18
Connect Basic to mains power .............................................................................................18
Check maximal vacuum for functional check ........................................................................ 18
Changing vacuum level..........................................................................................................19
Placing out of operation after use.......................................................................................... 19
8 Vacuum Assisted Delivery setup .......................................................................................20
9 Changing reusable jar .........................................................................................................21
2 | Table of Contents
10 Changing disposable liner ..................................................................................................22
11 Troubleshooting ..................................................................................................................24
No LED lit .............................................................................................................................. 24
Yellow LED indicator lit .......................................................................................................... 24
Motor not running .................................................................................................................. 24
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
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 accessories ............................................................................................................330
EN
Table of Contents | 3
Congratulations
By choosing the Basic, you have acquired a high-quality suction pump which is adaptable to your needs. As all Medela suction 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.
4 | Congratulations
1 Warnings and safety instructions
WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTIONS
Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.
Safety related tip
Indicating useful information about the safe use of the device.
The Basic is approved exclusively for the use as described in these instructions for use. Medela can only guarantee the safe functioning of the system when the Basic is used in combination with the original Medela accessories (collection system, tubings, filters etc. – see annex “II List of accessories”).
The Basic is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and IEC 60601-1-2:2014 4th Edition according to clause 7 and 8.9 and can be used in the vicinity of other EMC-tested devices that fulfil the requirements as outlined in the IEC 60601-1-2 standard. HF (high-frequency) surgical equipment, radio networks or the like can influence the operation 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.
EN
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.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
Subject to change.
Warnings and safety instructions | 5
WARNINGS
– For use only by medically trained persons who have been adequately trained in
suction procedures and in the use of aspirators.
– To avoid risk of electric shock, this equipment must only be connected to a fixed mains
socket with protective earth.
– The device must not be used for suctioning explosive, easily flammable or corrosive
liquids.
– The connecting tubing supplied with the device must never come into direct
contact with the suction area. A sterile suction catheter must always be used
(risk of infection). – Before cleaning the device, pull the plug out of the fixed mains socket. – 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. – Do not connect this device to a passive drainage tube. – Not suitable for setting at a low vacuum, as needed for example 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 network devices, mobile
phones, cordless telephones and their base stations, walki-talkie can affect the Basic
pump and should be kept at least a distance 1ft (30 cm) away from the equipment. – The rack version requires a minimum distance of 5 cm to the enclosure to prevent
overheating of the device. – The patient should be monitored regularly according to the physicians’ instructions and
facility guidelines. Objective indications or signs of a possible infection or complication
must be met immediately (e.g. fever, pain, redness, increased warmth, swelling or
purulent discharge).
Non-observance can lead to con si de rable danger of the patient. Monitor the Basic
frequently for opera ting status. – To prevent the device from overheating, the exhaust at the bottom of the unit must be
unobstructed when the unit is operational.
6 | Warnings and safety instructions
Safety related tip
– The Basic Suction Pump is Magnetic Resonance (MR) Unsafe. Do not take the pump
into the MR environment.
– 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.
– 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 voltage given on the specification plate.
EN
Warnings and safety instructions | 7
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 infor­mation in annex “I Technical documentation (EMC).”
– In the case of overflow, inform the internal technical service immediately and
perform the tasks in the service manual.
– In each of the following cases, the device must not be used and it must be
repaired by Medela Customer Service: – if the power cord or the plug are damaged – if the device is not functioning perfectly – if the device is damaged – if the device shows clear safety defects. – Keep the power 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 where there is a risk of explosion. – Never place the device in water or other liquids. – When using single use, sterile products, please note that they are not intended to be
reprocessed. Reprocessing could cause loss of mechanical, chemical and / or biologi-
cal characteristics. Reuse could cause cross contamination. – Contact your local Medela customer service representative for assistance with product
operations.
These instructions for use must be kept for later reference.
8 | Warnings and safety instructions
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.
Use the mounting bracket to secure the cord in the inlet port.
EN
Power supply | 9
3 Description
Introduction
The Basic is a high-quality suction pump. It is powered by a piston/cylinder system and pro­vides maximum suction performance for many suctioning needs. It ideally combines easy handling and cleaning with safety features to ensure optimal operation. You can choose from a comprehensive range of accessories from Medela to configure the pump to many medical applications. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal opera­tion in the configuration in which it will be used.
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 practice which require a vacuum in this setting such as: general surgery, liposuction, endos­copy, epicardial ablation, nasopharyngeal suction, neurosurgery, OPCAB, vacuum assisted cesarian/delivery and wound drainage.
Intended user
The Basic should only be operated by properly trained staff. These persons must not be hard of hearing or deaf and must have adequate visual faculty. The training should be refreshed at least once a year.
Intended patient population
The Basic is intended to be used on patients only exhibiting conditions as described in the indications for use.
Important note
Compliance with proper surgical procedures and techniques is the responsibility of the physi­cian. Each physician must evaluate the appropriateness of the treatment based on his own knowledge and experience.
10 | Description
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