Medela Basic User manual

Basic
SURGICAL SUCTION PUMP
EN Instructions for use

2 | Table of Contents
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

EN
Table of Contents | 3
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

4 | Congratulations
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.

EN
Warnings and safety instructions | 5
1 Warnings and safety instructions
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.
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.
Indicates a potentially hazardous situation which, if not avoided, could result in death or
serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in minor or
moderate injury.
Indicating useful information about the safe use of the device.
WARNINGS
CAUTIONS
Safety related tip

6 | Warnings and safety instructions
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 5cm 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 considerable danger of the patient. Monitor the Basic
frequently for operating status.
– To prevent the device from overheating, the exhaust at the bottom of the unit must be
unobstructed when the unit is operational.

EN
Warnings and safety instructions | 7
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.

8 | Warnings and 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).”
– 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.

EN
Power supply | 9
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.

10 | Description
3 Description
Introduction
The Basic is a high-quality suction pump. It is powered by a piston/cylinder system and pro-
vides 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 opera-
tion 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, 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 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 physi-
cian. Each physician must evaluate the appropriateness of the treatment based on his own
knowledge and experience.

EN
Overview | 11
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 -10kPa 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 and main
elements of the pump
Mobile version:

12 | Overview
Mechanical overflow protection
Tubing port
Lid with clamps
On/off button
Safety Set
0.25 l
Operating elements 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)

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 ø7x 12 mm with
2 coupling pieces
077.0922
Instructions for use
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
200.5524
or
5.1

14 | Installation
2. 2.1 Position pump on trolley.
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.
2. 2.1 Attach the Safety Set to
the pump.
Remove transport
lock
1. 1.1 Remove the red note
1.2 Remove 3 screws and
store them for later use.
5.2
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 protection to
the lid. Pull gently down-
wards to make sure it is
open/deactivated.
1.2 Attach the lid to the jar.
1.3 Close the two lid clamps.
1.1
1.2
1.3
5.5

EN
Preparation for use | 15
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 5cm 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).
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”.
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.
– 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.
6.1
Assembly of the
basic configuration
1. 1.1 Make sure that the Safety
Set is attached to the
Basic. See chapter 5.5.
6.2

16 | Preparation for use
1. If you use a DISPOSABLE collection system proceed
with step 6.4b
3. 3.1 Attach the lid to the jar and
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).
3.1 3.1
3.2
2. 2.1 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
11.1 Connect the optional foot
switch to the pump by
plugging in the plug.
1.2 Test the correct function-
ning of the foot switch.
6.3
Assembly of the
REUSABLE
collection system
positions for jars:
6.4a

EN
Preparation for use | 17
Assembly of the
DISPOSABLE
collection system
1. If you use a REUSABLE collection system proceed with
step 6.4a
2. 2.1 Choose the size neces-
sary for the application.
Yellow colour code: 1.5l,
Orange colour code: 2.5l.
2.2 Attach the jar to the
carrying handle (portable
version only) or to the
optional clampholder on
the trolley (see step 5.4).
positions for jars:
4.1 Connect tubing from the
jar (A) to the Safety Set
(B).
3.1 Prepare and insert
corresponding liner size
according 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 bar
as advised by your techni-
cian and according to
inhouse directives. The
respective cable is not
supplied from Medela.
to bus bar and
The equipotential conductor and connecting cables are
used to equalise the potential between equipment placed
in the hospital environment.
6.4b
6.5
4. A B
3.
5.

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.
3. 3.1 Seal the end of the patient
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.
+ 2000m – 70kPa
– 525mmHg
+ 1000m – 79kPa
– 592mmHg
+ 500m – 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. 3.1 An internal self-test is
performed. When the
green LED lights up, the
device is ready for use.
Check the pump before use following the instruction in
chapter 6.1.
1.
(Tolerance: +/- 15%)
7.1
7.2

EN
Operating instructions | 19
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
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

20 | Vacuum Assisted Delivery setup
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).

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.
3a 3.1 Attach 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
regulator to resting «zero
pressure» state (rear and
down using heel of foot).
5.2 The pump is now ready
for use.

+ 2000m – 70kPa
– 525mmHg
+ 1000m – 79kPa
– 592mmHg
+ 500m – 85kPa
– 638mmHg
0m – 90kPa
– 675mmHg
Altitude
above
sea level:
Specifications:
Max. Vacuum:
(Tolerance: +/- 15%)