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
Introduction ...........................................................................................................................10
Intended use / indications .......................................................................................................10
Intended user.........................................................................................................................10
Intended patient population ...................................................................................................10
Important note ....................................................................................................................... 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
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).
Handle with two
holders for jars
Versions and main
elements of the pump
Portable version:
Rack version:
Mobile version:
EN
Vacuum gauge
Vacuum regulator
Mobile trolley
(optional accessory)
Safety Set
On/off button
Standard rail
Foot on/off
switch (trolley)
All castors
with brakes
Overview | 11
Back of device
Operating elements and
indicators
Fuses
Appliance inlet
Equipotential conductor
green light Pump is plugged in
Cable holder
(with optional
trolley)
Port for
optional
foot on/off
switch
Medela
077.0723
On/off button
Safety Set
12 | Overview
yellow light Pump has an error. Refer to
white light Pump is running
Mechanical overflow protection
activated:
deactivated:
(ready for use)
cha p ter 11
Tubing port
Lid with clamps
Jar
0.25 l
5 Installation
Basic
SURGICAL SUCTION 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
EN
Check initial delivery
5.1
Check the delivery package of the Basic for completeness
and general condition.
Basic portable version
071.0000
or
Basic rack version
071.0001
Mains plug
See service manual
Safety Set
077.0711
Silicone Tubing ø 7 x 12 mm wit h
2 coupling pieces
077. 0 92 2
Instructions for use
200.5524
Installation | 13
Remove transport
5.2
lock
1. 1.1 Remove the red note
1.2 Remove 3 screws and
store them for later use.
Set up mobile version
5.3
(if available)
Assembly of the
5.4
optional clampholder
(when using the
trolley)
Set up the Safety Set 1. 1.1 Attach the mechanical
5.5
1. 1.1 Position top part of trolley
2. 2.1 Position pump on trolley.
1. 1.1 Press and hold the blue
1.3
1.1
1.2
on bottom part, making
sure the tubing fits as
shown.
1.2 Connect parts with
4 screws.
Make sure that the front
of the pump and the
standard rail point
forward.
2.2 Connect pump with
4 screws.
2.3 Attach the cable holder
with the two screws to the
pump.
release knob.
1.2 Attach the clampholder to
the standard rail by
releasing the blue knob.
overflow protection to
the lid. Pull gently downwards to make sure it is
open / de activated.
1.2 Attach the lid to the jar.
1.3 Close the two lid clamps.
14 | Installation
2. 2.1 Attach the Safety Set to
the pump.
6 Preparation for use
WARNINGS
For use only by medically trained persons who have been adequately trained in suction
procedures and in the use of aspirators.
CAUTIONS
– The Basic must remain in an upright position during use.
– The rack version requires a minimum distance of 5 cm to the enclosure to prevent from
overheating of the device. The back of the enclosure must be open.
– Sterile accessories must be checked to ensure the integrity of the packaging before
use.
– Non sterile and reusable accessories must be cleaned, disinfected and / or sterilized
according to the Medela cleaning guide (product code 200.2391).
Checks before use
6.1
– 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.
– Check all accessories prior to use:
– suction jars, lids and liners for cracks, brittle and flawed spots. Replace if
necessary.
– tubing for cracks, brittle areas and that connectors are firmly attached.
Replace if necessary.
– as an additional safety test, evacuate the system (including jars) to maximum
vacuum before actual use.
EN
Assembly of the
6.2
basic configuration
1. 1.1 Make sure that the Safety
Set is attached to the
Basic. See chapter 5.5.
2. 2.1 Attach a filter (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”.
Preparation for use | 15
6.3
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 functionning of the foot switch.
6.4a
Assembly of the
REUSABLE
collection system
positions for jars:
1. If you use a DISPOSABLE collection system proceed
with step 6.4b
2. 2.1 Attach mechanical
2.1
2.2
3. 3.1 Attach the lid to the jar and
3.2
3.1 3.1
4. 4.1 Connect tubing from the
5. 5.1 Connect patient tubing to
overflow protection to lid.
2.2 Pull gently downwards to
make sure it is
open / de activated.
lock with the two lid
clamps.
3.2 Attach the jar to the
carrying handle (portable
version only) or to the
optional clampholder on
the rail (see step 5.4).
Safety Set to the lid of the
jar (vacuum port).
the lid of the jar (patient
port).
16 | Preparation for use
EN
6.4b
Assembly of the
DISPOSABLE
collection system
positions for jars:
1. If you use a REUSABLE collection system proceed with
step 6.4a
2. 2.1 Choose the size neces-
3.
4.
A B
5.
sary for the application.
Yellow colour code: 1.5 l,
Orange colour code: 2.5 l.
2.2 Attach the jar to the
carrying handle (portable
version only) or to the
optional clampholder on
the trolley (see step 5.4).
3.1 Prepare and insert
corresponding liner size
according to instructions
delivered with liners. The
disposable liner has an
integrated overflow protection filter. No action is
necessary to activate it.
4.1 Connect tubing from the
jar (A) to the Safety Set
(B).
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).
6.5
Install equipotential
bonding
to bus bar
1. 1.1 Connect the equipotential
and
The equipotential conductor and connecting cables are
used to equalise the potential between equipment placed
in the hospital environment.
conductor at the back of
the Basic with the bus bar
as advised by your technician and according to
inhouse directives. The
respective cable is not
supplied from Medela.
Preparation for use | 17
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
7.1
mains power
Check maximal
7.2
vacuum for functional
check
Specifications:
Altitude
above
sea level:
+ 2000 m – 70 kPa
– 525 mmHg
+ 1000 m – 79 k Pa
– 592 mmHg
+ 500 m – 85 kPa
– 6 38 mmHg
0 m – 90 kPa
– 675 mmHg
(Tolerance: +/- 15 %)
18 | Operating instructions
Max. Vacuum:
Check the pump before use following the instruction in
1.
cha pte r 6.1.
2.
3. 3.1 An internal self-test is
1. 1.1 Switch on the Basic.
2. 2.1 Turn the vacuum regulator
3. 3.1 Seal the end of the patient
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.
performed. When the
green LED lights up, the
device is ready for use.
to the right to set
maximum vacuum
tubing with your thumb.
3.2 Compare the maximum
vacuum according to the
specification (on left). See
chapter 11 if the maximum
vacuum is not reached.
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.
EN
Changing vacuum
7.3
level
Placing out of
7.4
operation after use
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.
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.
Operating instructions | 19
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.
Specifications:
Altitude
above
sea level:
+ 2000 m – 70 kPa
– 525 mmHg
+ 1000 m – 79 kPa
– 592 mmHg
+ 500 m – 85 k Pa
– 6 38 mmHg
0 m – 90 kPa
– 675 mmHg
(Tolerance: +/- 15 %)
20 | Vacuum Assisted Delivery setup
Max. Vacuum:
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.
3a 3.1 Attach tubing from suction
cup to patient connection
on the lid of the liner.
or
3b 3.1 Attach tubing from suction
cup to patient connector
on suction jar of the reusable collection system.
4. 4.1 Switch on pump, turn to
max. vacuum, clamp tubing
from suction cup and fully
depress the vacuum
regulator (forward and
down, using ball of foot).
4.2 Compare maximum
vacuum according to
specification (on left).
5. 5.1 If OK, release vacuum by
returning foot vacuum
regulator to resting «zero
pressure» state (rear and
down using heel of foot).
5.2 The pump is now ready
for use.
9 Changing reusable jar
EN
1. 1.1 Switch pump off by
2. 2.1 Prepare new jar and
3. Empty jar and dispose of patient tubing according in
accordance with local guidelines and inhouse guidelines.
4. 4.1 Switch pump on by
touching the on/off button.
1.2 Remove patient and
vacuum tubings from the
lid.
1.3 Remove full jar from the
Basic.
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.
touching the on/off button.
Vacuum is built up.
4.2 Set vacuum according to
the particular application.
See chapter 7.3.
Changing reusable jar | 21
10 Changing disposable liner
WARNINGS
Disposable liners are not intended to be reprocessed. Reprocessing could cause loss
of mechanical, chemical and / or biological characteristics.
1.5 l 2.5 l
1. 1.1 Remove patient tubing
with coloured angle piece
from lid.
1.2 Plug patient port.
2. 2.1 Switch pump off by touching the on/off button.
3. 3.1 Reduce vacuum to minimum by turning vacuum
regulator to the left.
4. 4.2 Remove full liner from the
ja r.
22 | Changing disposable liner
5. Dispose of the liner and patient tubing in accordance with
local guidelines and inhouse guidelines.
EN
6. 6.1 Prepare new liner and
7. 7.1 Connect tubing from the
7.1
7.2
8. 8.1 Switch pump on by touch-
unpack it.
6.2 Insert new liner in the jar
and press down lid.
jar to the Safety Set.
7.2 Connect new patient tubing firmly.
ing the on/off button.
Vacuum is built up.
8.2 Set vacuum according to
the particular application.
See chapter 7.3.
Changing disposable liner | 23
11 Troubleshooting
No LED lit
The Basic is not connected to the mains or the fuse needs replacement.
Yellow LED indicator lit
Minor case
yellow LED indicator lit but the pump can be switched on and off:
– contact the internal technical department or your authorised service center at next possible
occasion.
Major case
yellow LED indicator lit and pump cannot be switched on and off:
– contact the internal technical department or your authorised service center for repairs /
maintenance.
Motor not running
Check to ensure:
– 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
ch apte r 12.
If the fault cannot be rectified, please contact the internal technical department.
Insufficient vacuum
Check if:
– the vacuum regulator is set correctly.
– the tubing is not defective or broken. If necessary, replace.
– all plug-in connections are tight.
– the overflow protection is deactivated / open. If the overflow protection 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.
24 | Troubleshooting
12 Replacing defective fuse
WARNINGS
Before replacing the fuse, pull the mains plug from Basic out of the fixed mains socket.
EN
1. 1.1 Disconnect the Basic from
2. 2.1 Open (pull out) the fuse
3. Replace the defective fuse(s). Make sure that the technical
specifications are correct.
T 1.6 AH, 250 VAC, 5 x 2 0 mm
4. 4.1 Close (push back) the fuse
the mains.
1.2 If attached, remove the
cable holder (2 screws on
bottom).
holder on the back of the
Basic.
holder.
5. 5.1 Reconnect the Basic to
the mains again.
5.2 Switch on the Basic again.
Replacing defective fuse | 25
13 Filter test
1. 1.1 Remove tubing from filte r.
2. 2.1 Select maximum vacuum.
3. 3.1 Switch on Basic by press-
4. 4.1 Read the vacuum.
ing the on/off button.
4.2 Replace the filter if the
vacuum exceeds - 20 kPa.
26 | Filter test
14 Cleaning guidelines
WARNINGS
After each use, the parts that have been in contact with the aspirated secretions are to be
cleaned, disinfected, sterilised or disposed of according to the table on the next page.
Before cleaning the device, pull the mains plug out of the fixed mains
socket.
Safety related tip
Avoid contact of fluids with the ends of the mains plug or appliance inlet port.
General notes
– 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.
– Dispose of fluids such as blood and secretions and the parts contaminated with them in
accordance with internal hospital guidelines.
Medela recommended surface cleaning agents for pump housing
– Perform [concentrate], Schülke & Mayr, www.schuelkemayr.com
Water
Use only the purest quality of water for cleaning. Water hardness is a serious consideration since
deposits left on medical products may not be properly decontaminated. Use deionised water in
order to reduce this problem. The final rinse water should be bacterial free and contains no
endotoxins.
EN
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. Every section of the
constituent parts must be accessible in order to ensure efficient cleaning. We recommend using
a cleaning/disinfecting machine that has been approved by the Robert Koch-Institute and
complies with ISO 15883. Recommended temperature for noncritical medical devices (i.e. those
that only come into contact with uninjured skin) is 90 °C for 1 minute. The time is increased to 5
minutes for all medical devices that are considered to be critical.
Disposable products
These are single use products not intended to be reprocessed. Reprocessing could
cause loss of mechanical, chemical and / or biological characteristics. Reuse could cause
cross contamination.
Cleaning guidelines | 27
PSU* jars, lids
PC** jars
Silicone
tubing
Reusable
suction cups
Pump housing
Mainscable
x x x x x x
x x x x
x x
x x x x x
Legend:
* Polysulfone
** Polycarbonate
Plastic
accessories
1. Disassembly
Separate all individual parts before cleaning, disinfecting and sterilising.
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 damaging the instruments and containment devices. Enzymatic detergents help with the removal of organic matter, such as blood.
Detergents should be used according to their manufacturer’s recommended concentration levels. Some alkaline detergents have
been formulated to be safe for reprocessing medical devices. The
manufacturers of these detergents should provide information
about specific materials that may be damaged by their detergents.
Soak all parts thoroughly with warm, soapy water or in enzymatic
detergent for 1–5 minutes.
1. Remove visible dirt with a cleaning tool – general purpose cleaning brushes, such as pipe cleaners or non-abrasive lint cloths.
Brushes and pipe cleaners should fit snugly but still be able to be
moved around easily within the area to be cleaned. Rinse thoroughly in clear water. Allow to dry.
2. Check the instruments for visible dirt and repeat these steps if
necessary.
3. Cleaning
Wipe with detergent mentioned above. Use clean cloth to dry.
4. Disinfect
Soak at room temperature for 30 minutes 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 2 minutes with the cleaning solution (B).
x x x
x x x x x
28 | Cleaning guidelines
(A) fluid aldehyde-free disinfection solution with cleaning effect for
use as a soaking bath, bactericide, fungicide, limited virucide, with
good material compatibility for stainless steel, non-ferrous material
and plastics including silicone, slightly alkalic. e.g. 2 % neodisher®
Septo MEDsolution
(B) Fluid, pH-neutral, enzymatic cleaning solution for the treatment
of instruments by machine or manually with very good material
compatibility for stainless steel, non-ferrous material and plastics
including silicone.
or use cleaning / desinfecting machine.
5. Sterilise
Remove any chemical disinfectant residue before autoclaving. Do
not stack during autoclaving. In the autoclave at 134 °C for 10 minutes. The sterilisation device must comply to ISO 17665:2003. The
following procedures are acceptable: In the autoclave with saturated steam at 132 °C, with triple pre-evacuation, sterilisation time of
6 minutes, or at 135–137 °C in an porous load vacuum autoclave
for 3 –3.5 min utes
6. Storing components
After disinfection/sterilising, store the components in sterile foil until
required for use.
15 Warranty and servicing
Warranty
Medela AG warrants the device will be free from defects in materials and workmanship for a
period of 5 years from the date of delivery. Faulty material will be replaced free of charge during
this period if not resulting from abuse or misapplication. This will not apply to parts subject to
wear and tear in use. To ensure compliance with this warranty as well as optimum service from
Medela products, we recommend the exclusive use of Medela accessories with our pumps.
In no event shall Medela AG be liable for claims which exceed the scope of warranty described
including liability for consequential damages, etc. The right to the replacement of faulty parts will
not be recognized by Medela if any work has been carried out on the pump by unauthorized
persons. This warranty is subject to the appliance being returned to a Medela service centre.
Servicing / Routine 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.
EN
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. Please take care that you dispose of the Basic and its accessories in accordance with
your local disposal guidelines.
User information for the disposal of electrical and electronic equipment
This symbol means that the electrical and electronic equipment must not be disposed
together with unsorted municipal waste. Correct disposal of this device protects and
prevents possible damage to the environment or human health. For more information
about the disposal contact the manufacturer, your local caregiver or healthcare provider. This
symbol is only valid in the European Union. Please respect the relevant state laws and rules in
your country for the disposal of electrical and electronic equipment.
Warranty & Maintenance | Disposal | 29
17 Accessories overview
WARNINGS
Basic was verified in combination with the accessories listed in annex “II List of accessories”. For correct and safe operation, use Basic with these accessories only. Further information is supplied on the instruction sheet of the individual accessory.
Safety related tip
If the pump is used together with third party patient interfacing devices (e.g. cannulas,
catheters), they must:
– have CE mark (within the European Union) and local registration
(outside the European Union)
– be able to be attached to Medela accessories safely without impacting the perfor-
mance of the pump.
Tubing connection on reusable lids of jars: Ø 6–10 mm, Ø 10–14 mm
Tubing connection on disposable liners: Ø 6.5–11 mm
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.
30 | Accessories overview
18 Technical specications
EN
high vacuum
- 90
kPa / - 675 mmHg
Tolerance: +/- 15
high flow
30 l/min.
+/- 5 l /min.
9.3 kg
20.5 lbs
Rack version
AC
100–240 V, 50 / 60 Hz
50 W
ISO 9001
ISO 13485
CE (93/42/EEC), IIa
H x W x D (rack versi on)
210 x 305 x 375 mm
8.2 x 12.0 x 14.8 inche s
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
Technical specifications | 31
19 Signs and symbols
This symbol
indicates the
compliance with
the essential
requirements
of the Council
Directive 93/42/
EEC of 14 June
1993 concerning
medical devices.
This symbol indicates the compliance with additional
USA and Canada
safety requirements
for medical electrical
equipment.
This symbol indicates
the legal specifications of the pump.
This symbol indicates
to follow instructions
for use.
This symbol indicates a CAUTION or
WARNING associated
with the device.
This symbol indicates
safety related tip.
This symbol indicates
earth (ground).
This symbol indicates
the class of the pump.
This symbol indicates
protective earth
(ground).
This Symbol indicates
the protection against
ingress of solid foreign
objects and against
harmful effects due to
the ingress of water.
This symbol indicates
a type CF applied
part.
This symbol indicates
MR
MR UNSAFE.
This symbol indicates
that interferences may
occur in the vicinity
of equipment marked
with this symbol.
This symbol indicates
the equipotential conductor connection.
This symbol indicates
the connection port
for the foot switch.
This symbol indicates
the date of manufacture.
This symbol indicates
that the device should
not be used after the
date shown.
This symbol indicates
a single use device.
Do not reuse the
device.
This symbol indicates
manufacturer’s
catalogue number.
This symbol indicates
manufacturer’s serial
number.
This symbol indicates
manufacturer’s batch
code.
This symbol
indicates the
device is
sterilized using
ethylene oxide.
This symbol indicates
the temperature limitation for operation,
transport and storage.
32 | Signs and symbols
This symbol indicates
the manufacturer.
EN
This symbol indicates
the humidity limitation
for operation, transport and storage.
This symbol indicates
the atmospheric
pressure limitation for
operation, transport
and storage.
This symbol indicates
do not use the device
if package is damaged.
This symbol indicates
∑
the number of items
n that the content is
sufficient for.
This symbol indicates
to not dispose the
device together with
unsorted municipal
waste (for EU only).
This symbol indicates
that the material is
part of a recovery/
recycling process.
This symbol indicates
a carton package.
This symbol indicates
to handle the fragile
device with care.
This symbol indicates
to keep the device
dry.
This symbol indicates
the maximum vacuum
level of the pump.
This symbol indicates
the flow levels of the
pump.
AC
This symbol indicates
the electrical specifications of the pump.
This symbol indicates
the weight of the
pump.
This symbol indicates
the dimensions
(h x w x d) of the pump.
This Symbol indicates
a Prescription Device.
U.S. Federal law
restricts this device to
sale by or on the order
of a physician (for US
only).
This symbol indicates
the fuse
This symbol indicates
to keep the device
away from sunlight.
This symbol indicates
pcs
number of items.
Signs and symbols | 33
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