Medela Basic 30 User manual
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2 | Table of contents
EN
Table of contents | 3
11 Troubleshooting ............................................................................................................... 22
Motor not running ............................................................................................................... 22
Insufficient vacuum............................................................................................................. 22
No LED lit............................................................................................................................ 22
12 Replacing defective fuse ................................................................................................. 23
13 Filter test............................................................................................................................ 24
14 Cleaning guidelines.......................................................................................................... 25
General notes ..................................................................................................................... 25
Water .................................................................................................................................. 25
Cleaning/Disinfection machines ......................................................................................... 25
Medela recommended surface cleaning agents
for pump housing................................................................................................................ 25
Disposable products........................................................................................................... 25
15 Warranty & Maintenance ................................................................................................. 27
Warranty ............................................................................................................................. 27
Maintenance/Routine check .............................................................................................. 27
16 Disposal ............................................................................................................................ 27
17a Accessories overview (rack/mobile) .............................................................................. 28
17b Accessories overview (portable)..................................................................................... 30
18 Accessories legend.......................................................................................................... 32
19 Technical specifications .................................................................................................. 35
20 Signs & Symbols............................................................................................................... 36
21 Index .................................................................................................................................. 38
22 Technical documentation (EMC) ................................................................................... 382
4 | Congratulations
Congratulations
By choosing the Basic 30, 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 30 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 & Safety instructions | 5
1 Warnings & Safety instructions
The Basic 30 is approved exclusively for the use as described in these instructions for use.
Medela can only Warranty the safe functioning of the system when the Basic 30 is used in
combination with the original Medela accessories (collection system, tubings, filters etc. – see
chapter 17).
The Basic 30 is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 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. Untested HF sources, radio networks or the like can impair the function
of the device and should not be operated in combination with the Basic 30.
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 considers herself only responsible for the effect on BASIC SAFETY, reliability and
performance of the Basic 30 if it is used in accordance with the Instructions for Use.
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.
Caution
Federal US law restricts this device to sale by or on the order of a health professional.
Subject to change.
6 | Warnings & Safety instructions
WARNINGS
– For use only by medically trained persons who have been adequately trained in
suction procedures and in the use of aspirators.
– 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.
– Do not connect this device to a passive drainage tube.
– Consult the indications for use and consider risk factors and contraindications before
using the Basic 30. Failure to read and follow all instructions in this manual prior to use
may result in serious or fatal injury of the patient.
CAUTIONS
– Incorrect use can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– The use of mobile telephones. LAN/WLAN, walkie-talkies (two-way radios) and
cordless telephones sets can affect the Basic 30 pump. A safety distance of min. 3.3ft
(1m) to the Basic 30 pump is recommended.
– Portable and mobile RF communications equipment can affect medical devices.
– 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 30 frequently for operating status
Safety related tip
– For safety tests (STC), it is assumed that the device is serviced and repaired through-
out its service life in accordance with the service manual. Because the Basic 30 is a
device of safety class lI (EN IEC 60601-1, A1, A2:1995), the safety tests (STC) are
confined to visual inspection of the housing and power cord. This test must be carried
out before each use.
– Testing the patient leakage current: Please see service manual for details.
– The protection of the Basic 30 against the effects of the discharge of a cardiac defibril-
lator 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 & Safety instructions | 7
Safety instructions
– The Medela Basic 30 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 attached EMC infor-
mation.
– 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
Customer Services:
– 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 and the on /off switch 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 repro-
cessed. Reprocessing could cause loss of mechanical, chemical and/or biological character-
istics. Reuse could cause cross contamination.
– Contact your local Medela customer service representative for assistance with product oper-
ations.
These instructions for use must be kept for later reference.
8 | Power supply
2 Power supply
The Basic 30 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.
EN
Description | 9
3 Description
Introduction
The Basic 30 is a high-quality suction pump. It is powered by the well-proven piston/cylinder
system and guarantees maximum suction performance for many suctioning needs.
It ideally combines easy handling and cleaning with safety features to ensure optimal opera-
tion. 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
The Basic 30 is a powered high flow, high vacuum suction pump intended to be used either
for vacuum assisted
delivery, aspiration/removal of secretions, surgical irrigation fluids, tissue (including bone),
gases, body fluids (incl. vomit) and non-/infectious fluids and materials. It is designed for
continuous use in the hospital, the clinic setting or in doctors’ practices.
Contraindications
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.
Intended user
The Basic 30 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 has to be
refreshed at least once a year.
Intended patient population
The Basic 30 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.
Service life
The service life of the device is seven years.
10 | Overview
4 Overview
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
values 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).
Definition of vacuum
Rack version:
Mobile version:
Handle with two
holders for jars
Portable version:Versions and main
elements of the pump
Safety Set
Vacuum regulator On/off switch
Vacuum gauge
class 2.5 DIN 16005
Standard rail
Equipotential conductor
Mobile trolley Foot on/off
switch (trolley)
Two castors
without brakes
Two castors
with brakes
Port for optional
foot on/off switch
Medela
077.0723
EN
Overview | 11
On/off switch
Standby LED
Indicators
green
light
green
light
Pump is running
Pump is plugged in and in
standby mode
activated:
deactivated:
(ready for use)
Mechanical overflow protection
Tubing port
Lid with clamps
Safety Set
Jar 0,25l
Cable holder
Fuse
Mains cable
Back of device
12 | Installation
Check initial
delivery
5 Installation
Check the delivery package of the Basic 30 for completeness
and general condition.
Silicone Tubing ø 7 x12 mm with
2 coupling pieces
077.0 922
Instructions for use
200.2738
5.1
Safety Set
077.0711
Basic 30 rack version
037.XXXX
or
Basic 30 mobile version
037.XXXX
or
Basic 30 portable version
037.XXXX
EN
Installation | 13
Set up mobile
version
(if available)
5.3 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.
2. 2.1 Position pump on trolley.
Make sure that the front of
the pump and the stan-
dard rail point forwards.
2.2 Connect pump with
4 screws.
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 releas-
ing 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.
2. 2.1 Attach the Safety Set to
the pump.
5.5
1.1
1.2
1.3
Remove
transport lock
5.2 1. 1.1 Remove the red note
1.2 Remove 4 screws and
store them for later use.
14 | Preparation for use
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 30 must remain in an upright position during use.
– Sterile accessories must be checked on 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).
– Check the Basic 30 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 30 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.
Checks before use
6.1
3. Attach all necessary accessories according to your needs.
See chapters 17/ 18 for more details.
2. 2.1 Attach a filter (if required)
to the safety set with the
arrow pointing in the flow
direction. The filter must
be exchanged after an
overflow and after each
patient, but latest after a
week.
Assembly of the
basic configuration
1. 1.1 Make sure that the Safety
Set is attached to the
Basic 30. See chapter 5.5.
6.2
EN
Preparation for use | 15
Assembly of
the REUSABLE
collection system
1. If you use a DISPOSABLE collection system proceed
with step 6.4b
6.4a
Assembly of the
optional foot switch
1. 1.1 Connect the optional foot
switch to the pump by
plugging in the plug.
1.2 Test the correct function-
ning of the foot switch.
6.3
4. 4.1 Connect tubing from the
Safety Set to the lid of the
jar (vacuum port).
3. 3.1 Attach the lid to the jar and
lock with the two lid
clamps.
3.2 Attach the jar to the carry-
ing 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 over-
flow protection to lid.
2.2 Pull gently downwards to
make sure it is
open/ deactivated.
2.1
2.2
positions for jars
(depending on the
configuration):
5. 5.1 Connect patient tubing to
the lid of the jar (patient
port).
16 | Preparation for use
positions for jars
(depending on the
configuration):
Install equipotential
bonding
1. 1.1 Connect the equipotential
conductor at the back of
the Basic 30 with the bus
bar as advised by your
technician and according
to inhouse directives. The
respective cable is not
supplied from Medela.
6.5
to bus bar
Assembly of
the DISPOSABLE
collection system
6.4b 1. If you use a REUSABLE collection system proceed with
step 6.4a
2. 2.1 Choose the size neces-
sary for the application.
Orange colour code: 2.5l,
yellow colour code: 1.5l
2.2 Attach the jar to the carry-
ing handle (portable
version only) or to the
optional clampholder on
the trolley (see step 5.4).
3. 3.1 Prepare and insert corre-
sponding 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. 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).
4. 4.1 Connect tubing from the
jar (A) to the Safety Set
(B).
A B
EN
Operating instructions | 17
7 Operating instructions
CAUTIONS
The Basic 30 is to be set up in such a way, that a separation from the mains supply
can be easily managed.
Connect Basic 30
to mains power
Check the pump before use following the instruction in
chapter 6.1.
1.
7.1
2. 2.1 Plug in the mains plug of
the power cord to a fixed
mains socket.
3. 3.1 The LED on the housing
will light up to indicate
standby mode.
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.
+2000 m –66kPa
–495 mmHg
+1000m –75kPa
–562 mmHg
+500m –80kPa
–600mmHg
0m –85 kPa
–638 mmHg
Check maximal
vacuum for
functional check
1. 1.1 Switch on the Basic 30.
The pump will start
running.
7.2
2. 2.1 Turn the vacuum regulator
to the right to set
maximum vacuum
Altitude
above
sea level:
(Tolerance: +/- 10%)
Specifications:
Max. Vacuum:
18 | Operating instructions
CAUTIONS
When the Basic 30 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.
7.3
2. 2.1 Disconnect the mains plug
from the fixed mains
socket.
3. Clean and desinfect the Basic 30. See chapter 14.
Placing out of
operation after use
1. 1.1 Press on/off switch to
switch off the Basic 30.
7.4
EN
Vacuum Assisted Delivery setup | 19
2. 2.1 Connect the foot vacuum
regulator: the silver adapter
must be fully seeded in the
Safety Set (overflow jar) of
the suction pump.
2.2 Attach tubing to top of
metal adapter.
4. 4.1 Switch on pump, turn to
max. vacuum, clamp tubing
from suction cup and fully
depress the vacuum regula-
tor (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 30 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 Preparation
for use (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 port on
suction jar of the reusable
collection system.
or
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.
+2000 m –66kPa
–495 mmHg
+1000m –75kPa
–562 mmHg
+500m –80kPa
–600mmHg
0m –85 kPa
–638 mmHg
Altitude
above
sea level:
Specifications:
Max. Vacuum:
(Tolerance: +/- 10%)
20 | Changing reusable jar | Changing disposable liner
9 Changing reusable jar
WARNINGS
Disposable liners are not intended to be reprocessed. Reprocessing could cause loss
of mechanical, chemical and/or biological characteristics.
10 Changing disposable liner
3. Empty jar and dispose of patient tubing according in accor-
dance with local guidelines and inhouse guidelines.
2. 2.1 Prepare new jar and
unpack it.
2.2 Secure new jar in the
clampholder or directly to
the Basic 30
2.3 Reconnect vacuum tubing
and new patient tubing
firmly.
1. 1.1 Switch pump off by
pressing the on/off switch.
1.2 Remove patient and
vacuum tubings from
the lid.
1.3 Remove full jar from the
Basic 30.
1. 1.1 Remove patient tubing
with coloured angle piece
from lid.
1.2 Plug patient port.
4. 4.1 Switch pump on by
pressing the on/off switch.
Vacuum is built up.
4.2 Set vacuum according to
the particular application.
See chapter 7.3.
1.5 l 2.5 l
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