Basic 30 Instructions for Use Jan 2011

EN

Instructions for use

2

DE

Gebrauchsanweisung

16

FR

Mode d'emploi

30

IT

Istruzioni per l’uso

44

NL

Gebruiksaanwijzing

58

SV

Bruksanvisning

72

FI

Käyttöohjeet

86

NO

Bruksanvisninger

100

ES

Instrucciones de Uso

114

PT

Instruções de utilização

128

A

Technical Documentation (EMC)

142

B

Safety-related checks

146

Caution: Federal US law restricts this device to sale by or on the order of a health professional.

Subject to change

1

l

Congratulations

The Basic 30 is a high-quality secretion aspirator. Its well-proven piston / cylinder system guarantees maximum suction performance and quiet, dependable operation. The simple handling and cleaning as well as the safety features are additional advantages of the Medela secretion aspirators. A comprehensive range of accessories makes the Basic 30 ideally suited to a wide range of medical applications. Contact us – we will be pleased to advise you!

ll

Intended use

The Basic 30 is indicated for the vacuum extraction, aspiration and removal of surgical fluids, tissues (including bones), gases, bodily fluids or infectious materials from wounds or from the airways of the patient eitherduring surgery or on the ward. Applications • General surgery • Vacuum extraction For vacuum extraction, the Basic 30 must be used in combination with Medela accessories (suction cups and tubes). Otherwise, Medela can not guarantee the safe functioning of the system. • Wound drainage When the Basic 30 is used for wound drainage, it must be ensured that the wound does not dry out and that the dressing is applied tightly. If an unusually high amount of fluids collects in the secretion container (high blood loss), the wound drainage must be interrupted. • ENT A replacement device must always be available for patients for whom a breakdown of the device can lead to a critical situation (e.g. patients with dyspnoea or heavy mucous congestion). Contraindications Currently no contraindications are known to us. 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.

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EN

lII Warnings / Safety instructions The Basic 30 is approved exclusively for the use as described in these instructions. Medela can only guarantee the safe functioning of the system when the Basic 30 is used in combination with the original Medela accessories (collection system, tubes, filter etc.). 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 fulfill the requirements as outlined in the IEC 60601-1-2 standard. Untested HF sources, radio networks or the like can imapir the function of the device and should not be operated in combination with the Basic 30.

Please read and observe these warnings and safety instructions before putting into operation. Warnings • For use only by medically trained persons who have been adequately trained in suction procedures and in the use of aspirators. Caution: incorrect use can cause pain and injury to the patient. • Before you plug in the device, please check that your local power supply is the same as the voltage given on the specification plate. • 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. • Before cleaning the device, pull the plug out of the mains socket.

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 information. • Portable and mobile RF communications equipment can affect medical devices. • 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 cord away from hot surfaces. • The plug and the ON / OFF switch must not come into contact with moisture. • Separation from the mains is only assured through the disconnection of the plug and socket connection. • Never pull the plug out of the mains socket by pulling on the power cord! • Never leave the device unattended when it is switched on.

These instructions for use must be kept for later reference. EN

3

lV Safety tests For safety tests (STK), it is assumed that the device is serviced and repaired throughout its service life in accordance with the service manual. Because the Basic 30 is a device of safety class II (EN IEC 60601-1, A1, A2:1995), the safety tests (STK) are confined to visual inspection of the housing and power cord. This test must be carried out before each use. Devices of protection class II do not have a protective earth conductor, therefore a check of the earth leakage current is not necessary! The housing of the Basic 30 is made entirely of insulating material. Tests of the housing leakage current using common measuring instruments will therefore not reveal measurable values. The applied parts of the Basic 30 are connected to the Basic 30 with non-conductive hoses, containers and intermediate hoses. Even when suctioning a conductive fluid until the overflow protection device activates (9 g / L NaCl; EN ISO 10079-1;1999), measurements of the patient leakage current using common measuring instruments will not reveal measurable values The Basic 30 does not have patient leakage current, signal input and output parts and functional earth leakage current.

V

Occupational health and safety

Guidelines for Medela and agency workshops. We recommend a hepatitis B vaccination for all persons who have to deal with potentially contaminated devices. Further safety measures with regard to further vaccinations or other safety precautions are to be observed individually depending on the region. When devices are returned to workshops for repair, the devices / components have to be considered as being dangerous and potentially infectious. Such devices must be stored separately, specially marked and at an isolated location until they are disinfected.

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EN

VI Important Notes 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 -10 kPa for example always refers to a pressure range in kPa below atmospheric ambient pressure.

Vll Guarantee 5 year guarantee after date of delivery for the device. Medela assumes no liability for modified devices, damage or consequential damage caused by improper handling, inappropriate use as well as manipulation by unauthorised persons. Routine checks and service work are only to be carried out by positions authorised by Medela.

VllI Maintenance / Routine check Routine checks and service work are only to be carried out by positions authorised by Medela. The routine check is to be carried out 1x per year. (see service manual).

EN

5

IX Overview of Basic 30

Silicone tube Vacuum gauge class 2.5 DIN 16005

Safety device

Vacuum regulator

Standard rail

Reusable jar (Optional) Foot switch (Optional)

Mobile stand (Optional)

ON / OFF switch

Castors with brakes

6

EN

X

Accessories

Correct and safe functioning can only be guaranteed with Medela accessories.

Reusable system

Fluid Management System 1L

077.0110

2L

077.0120

3L

077.0130

5L

077.0150

077.0420 Size standard for all jars

1.5 L 077.0082 2.5 L 077.0085

1.5 L 077.0083 2.5 L 077.0086

Disposable system

Without solidifier

1.5 L 077.0084 2.5 L 077.0087 With solidifier

Further accessories

077.0563

077.0571

077.0922

077.0951

077.0012

077.0531

077.0723

077.0731

077.0762

EN

7

XI Initial Setup Use only after instruction by qualified personnel.

1

Preparation for use Check required parts. • Basic 30

• Tubing set

• Safety device

2

Assembly • Decision: disposable or reusable system.

For reusable system: • Mechanical overflow protection must be open. Pull downwards. • Position jar in clamp holder. • Connect tubing.

3

Power • Plug in.

8

EN

4

Functional check Ensure that sufficient vacuum is produced. • Switch device on.

• Set maximum vacuum.

• Seal the end of the patient tubing with your thumb.

• Compare the vacuum.

Max. vacuum according to technical specifications

OK?

+ 2,000 m

– 66 kPa

– 495 mmHg

+ 1,000 m

– 75 kPa

– 563 mmHg

+ 500 m

– 80 kPa

– 600 mmHg

0m

– 85 kPa

– 638 mmHg

not OK, see Troubleshooting.

OK

5

Use • Select correct vacuum according to the particular application.

EN

9

XII Change disposable liner / reusable jar - on the basis of a visual check

Reusable system

Disposable system

1

Prepare jar.

Prepare liner.

2

a. Remove tubing. b. Switch pump off. c. Remove jar.

a. Remove patient tubing. b. Plug liner ports. c. Switch pump off. d. Remove liner.

d. Unpack new jar, secure in clamp holder. e. Reconnect tubing.

e. Unpack new liner, place in jar. f. Reconnect patient tubing.

f. Empty jar.

g. Dispose of liner in accordance with local guidelines.

3

a. Switch on. Vacuum is built up. b. Check vacuum.

10

EN

XlII Troubleshooting Motor not running

Check • Mains voltage • Switched on • Fuse

Insufficient vacuum

Check • Regulator setting • Tubing • Plug-in connections • Overflow protection • Suction jar and lid (cracks, brittle areas, discolouration) • Disposable system (cracks, brittle areas, discolouration)

If the fault cannot be rectified, please contact the internal technical department.

XlV Cleaning and sterilisation After each use, the parts that had been in contact with the aspirated secretions are to be cleaned, disinfected, sterilised or disposed of. Before cleaning the device, pull the plug out of the mains socket. General notes • The internal hospital guidelines take precedence. • Disconnect the Basic 30 from the mains before cleaning / disinfection. • Clean the device with a moist cloth and non-abrasive agents. • Suction jar, lid, disposable liner and other accessories are to be treated in accordance with the supplied instruction sheets. • 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. • Empty the jar or dispose of liner regularly. • Detailed information according to Medela cleaning instructions 200.2391. Medela recommends the following surface cleaning agents Disinfecting agent

Active ingredients

Hexaquart plus (aldehyde-free) [concentrate]

Didecyldimethylammonium chloride 6 g Lauryl dipropylene triamine 5.5 g Biguanidine acetate 4.2 g

B. Braun Medical AG www.bbraun.ch

Perform [concentrate]

Potassium peroxomonosulphate Sodium benzoate Tartaric acid Non-anionic surfactants Soap phosphate Perfumes

Schülke & Mayr www.schuelkemayr.com

Amount in Manufacturer 100g

20 g 15 g 10 g 5 – 15% 5 – 15% < 5%

EN

11

Pump housing, Mains cable

Disposable products (e.g. disposable liner)

Cleaning

Disinfection

Sterilisation

✔

✔

✘

Wipe off with a damp cloth.

With disinfecting agent (see above)

Can not be autoclaved

These are disposable items and must not be reused. Replace after every use! Reprocessing could cause loss of mechanical, chemical and / or biological characteristics.

Cleaning the reusable jar and lid (PSU and PC) For optimum user safety, we recommend checking the reusable jar and lid before each use as natural damage can occur with time. This check consists of a visual check and evacuation of the jar at maximum vacuum. Faulty jars and lids should be replaced. Polysulfone (PSU) jar Disinfect and sterilise for 10 minutes at 134° C / 273° F. Remove all residues from chemical disinfection agents before autoclaving. Do not stack when autoclaving. Do not use any phenol-based cleaning agents. With proper use, reusable jars (PSU) and lids have a service life of 2 years or 200 autoclaving cycles. After this time, jars and lids must be replaced for safety reasons. Polycarbonate (PC) jars Do not autoclave. The maximum disinfection temperature is 100° C / 212° F. Information from the manufacturer regarding concentration, soaking times or temperature must be observed. Silicone tubing Can be autoclaved for 10 minutes at 134° C / 273° F.

XV Disposal The Basic 30 comprises metals and plastics and should be disposed of in accordance with the European directives 2002 / 95 / EC and 2002 / 96 / EC. Additional, local guidelines must also be observed.

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EN

XVl Article numbers and descriptions Correct and safe functioning can only be guaranteed with Medela accessories. Optional accessories - not included in the scope of delivery

Reusable system

Disposable system

077.0110

1 L PSU jar

077.0082

1.5 L PC jar

077.0120

2 L PSU jar

077.0085

2.5 L PC jar

077.0130

3 L PSU jar

077.0083

1.5 L disposable liner

077.0150

5 L PSU jar

077.0086

2.5 L disposable liner

077.0420

Lid large, conical patient connection

077.0084

1.5L disposable liner with solidifier

077.0125

0.25 L PSU jar

077.0087

2.5 L disposable liner with solidifier

077.0155

0.5 L PSU jar

077.0440

Lid small, conical patient connection

EN

13

Further accessories

14

EN

077.0563

Change-over-valve

077.0571

Overflow protection / bacteria filter

077.0922

Silicone tubing ∅ 7 x 12 mm, 60 cm with 2 coupling pieces

077.0951

Disposable tubing (PVC), 180 cm with fingertip, sterile

077.0762

Suction cup SilcCup, ∅ 60 mm

017.0012

Apgar Timer

077.0531

Quiver with holder

077.0723

Foot On / Off switch

077.0731

Foot vacuum regulator

A

Index

A Accessories 2, 3, 7, 11, 13, 14 Ambient pressure 5 Applications 2 Article numbers 13

P Patient tubing 9, 10 Plug 3, 8, 11 Pressure 5 Putting into operation 3

C Check 3, 4, 5, 9, 10, 12 Cleaning 2, 3, 11, 12 Consequential damage 5 Contraindications 2

R Range of accessories 2 Reusable jar 6, 10 Reusable system 7, 8, 10, 13 Routine check 5

D Disinfecting agent 11 Disinfection 11, 12 Disposable system 7, 8, 10, 11, 13 Disposal 12

S Safety features 2 Safety instructions 3 Safety measures 4 Safety set 6, 8 Scope of delivery 13 Silicone tube 6 Silicone tubing 12, 14 Standard rail 6 Sterilisation 11, 12 Suction area 3

E ENT 2 F Foot switch 6 Functional check 9 Functioning 2, 3, 7, 13 Fuse 11 G Guarantee 5 Guidelines 4, 10, 11, 12 H Handling 2, 5 I Indication 5 Initial setup 8 J Jar 8, 10, 11, 12, 13 K Kilopascal 5

T Troubleshooting 9, 11 Tubes 2, 3 Tubing 3, 8, 9, 10, 12, 14, 34 Tubing set 8 U Use 2, 3, 5 V Vacuum 2, 5, 9, 10, 12, 14 Vacuum gauge 6 Vacuum regulator 6, 14 Voltage 3, 11 W Warnings 3 Wound drainage 2

L Liability 5 Liner 10, 11, 12, 13 M Mains 3, 11 Maintenance 5 Mobile stand 6 O ON / OFF switch 3, 6 Overflow protection 11, 14 EN

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A

Technical Documentation (EMC)

IEC 60601-1-2, Table 201

Electromagnetic Emissions Basic 30 is intended for use in the electromagnetic environment specified below. The customer or the user of Basic 30 should assure that they are used in such environment. Emission Tests

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

Basic 30 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Basic 30 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctutions / flicker emissions IEC 60000-3-3

Complies

Warning – Basic 30 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, Basic 30 should be observed to verify normal operation in the configuration in which it will be used.

142

A

Technical Documentation (Con't)

IEC 60601-1-2, Table 202

Electromagnetic Immunity Basic 30 is intended for use in the electromagnetic environment specified below. The customer or the user of Basic 30 should assure that they are used in such environment. Immunity Tests

IEC 60601 test level

± 6 kV contact Electrostatic Discharge (ESD) ± 8 kV air IEC 61000-4-2

Compliance level

Electromagnetic environment - guidance

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input / output lines

± 2 kV for power supply lines ± 1 kV for input / output lines

Surge IEC 61000-4-5

± 1 kV differential mode ± 2 kV common mode

± 1 kV Mains power quality should be that differential mode of a typical commercial or hospital ± 2 kV environment. common mode

<5 % UT Voltage dips, (>95 % dip in UT) short interruptions and voltage for 0.5 cycle variations on 40 % UT power supply (60 % dip in UT) input lines IEC 61000-4-11 for 5 cycles

<5 % UT Mains power quality should be that (>95 % dip in UT) of a typical commercial or hospital for 0.5 cycle environment. If the user of Basic 30 requires continued 40 % UT operation during power mains (60 % dip in UT) interruptions, it is recommended for 5 cycles that Basic 30 be powered from an uninterruptible power supply or a 70 % UT battery. (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) for 5 sec for 5 sec Power frequency 3 A/m (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

Power frequency magnetic fields should be at levels of a typical commercial or hospital environment.

143

A

Technical Documentation (Con't)

IEC 60601-1-2, Table 204

Electromagnetic Immunity Basic 30 is intended for use in the electromagnetic environment specified below. The customer or the user of Basic 30 should assure that Basic 30 is used in such environment. Immunity Tests

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of Basic 30, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4

3 Vrms 150 kHz to 80 MHz

3 Vrms

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.2 √ P d = 1.2 √ P 80 MHz to 800 MHz d = 2.3 √ P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

144

a

Field strengths from fixed RF transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Basic 30 are used exceeds the applicable RF compliance level above, Basic 30 should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating Basic 30.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

A

Technical Documentation (Con't)

IEC 60601-1-2, Table 206

Recommended separation distance between portable and mobile RF communications equipment and Basic 30

Basic 30 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Basic 30 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Basic 30 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

W

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 √ P

d = 1.2 √ P

d = 2.3 √ P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

145