Basic Instructions for Use June 2014

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

Notes

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EN 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 & Maintenance...29 Warranty...29 Maintenance / Routine check...29 16 Disposal ...29 17 Accessories overview (rack / mobile)...30 18 Accessories overview (portable)...32 19 Accessories legend...34 20 Technical specifications...37 21 Signs and symbols...38 22 Technical documentation...386

Table of Contents

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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 a ­ pplications and can be used for continuous operation. Contact us – we will be p ­ leased to advise you.

4 | Congratulations

EN

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 chapter 17+18). The Basic 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. 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 Federal US law restricts this device to sale by or on the order of a health professional. Subject to change. Warnings and safety instructions

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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 s­ erious 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. 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 pump. A safety distance of min. 3.3 ft (1 m) to the Basic pump is recommended. – Portable and mobile RF communications equipment can affect medical devices. – 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 con­­si­de­rable danger of the patient. Monitor the Basic frequently for opera­ting status.

6 | Warnings and safety instructions

EN 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.

Warnings and safety instructions

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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 chapter 22. – 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 biological 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

EN

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.

Power supply

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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

EN

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 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 (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: Vacuum gauge Vacuum regulator

Safety Set

On/off button

Standard rail Mobile trolley (optional accessory)

Foot on/off switch (trolley)

All castors with brakes

Overview

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Back of device

Cable holder (with optional trolley) Port for optional foot on/off switch Medela 077.0723

Fuses Appliance inlet Equipotential conductor

Operating elements and indicators On/off button green light

Pump is plugged in

yellow light

Pump has an error. Refer to chapter 11

white light

Pump is running

Tubing port Lid with clamps

Safety Set

Mechanical overflow protection

activated: deactivated: (ready for use)

12 | Overview

Jar 0.25 l

EN

5 Installation 5.1 Check initial delivery

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 with 2 coupling pieces 077.0922

Instructions for use 200.5524

Installation

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transport 5.2 Remove lock

1.

1.1 Remove the red note 1.2 Remove 3 screws and store them for later use.

up mobile version 1. 5.3 Set (if available)

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 standard rail point forward. 2.2 Connect pump with 4 screws. 2.3 Attach the cable holder with the two screws to the pump.

1.

1.1 Press and hold the blue release knob. 1.2 Attach the clampholder to the standard rail by releasing the blue knob.

of the 5.4 Assembly optional clampholder

(when using the trolley)

5.5 Set up the Safety Set

1.

1.3

1.2 2.

14 | Installation

1.1

1.1 Attach the mechanical overflow protection to the lid. Pull gently downwards to make sure it is open / deactivated. 1.2 Attach the lid to the jar. 1.3 Close the two lid clamps. 2.1 Attach the Safety Set to the pump.

EN

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. – 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). before use 6.1 Checks – 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. of the 6.2 Assembly 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. The filter must be exchanged after an overflow and after each patient, but latest after a week.

3. Attach all necessary accessories according to your needs. See chapters 17 / 18. Preparation for use

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6.3

Assembly of the optional foot switch

of the 6.4a Assembly REUSABLE collection system

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.

1. If you use a DISPOSABLE collection system proceed with step 6.4b 2.

positions for jars:

2.1

2.1 Attach mechanical overflow protection to lid. 2.2 Pull gently downwards to make sure it is open / deactivated.

2.2 3. 3.2 3.1

16 | Preparation for use

3.1

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).

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).

EN of the 6.4b Assembly DISPOSABLE collection system

1. If you use a REUSABLE collection system proceed with step 6.4a 2.

2.1 Choose the size necessary 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.

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.

positions for jars:

4.

6.5

Install equipotential bonding to bus bar

A

B

4.1 Connect tubing from the jar (A) to the Safety Set (B).

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).

1.

1.1 Connect the equipotential 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.

and

The equipotential conductor and connecting cables are used to equalise the potential between equipment placed in the hospital environment. Preparation for use

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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. Basic to 7.1 Connect mains power

1. Check the pump before use following the instruction in chapter 6.1. 2.

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.

3.

3.1 An internal self-test is performed. When the green LED lights up, the device is ready for use.

maximal 1. 7.2 Check vacuum for functional

1.1 Switch on the Basic.

check

2.

2.1 Turn the vacuum regulator to the right to set maximum vacuum

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.

Specifications: Altitude above sea level:

Max. Vacuum:

+ 2000 m + 1000 m + 500 m 0 m

– 70 kPa – 525 mmHg – 79 kPa – 592 mmHg – 85 kPa – 638 mmHg – 90 kPa – 675 mmHg

(Tolerance: +/- 15 %)

18 | Operating instructions

EN 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. vacuum 7.3 Changing 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.

out of 7.4 Placing 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.

Operating instructions

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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. 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.

3b

or

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).

Specifications: Altitude above sea level:

Max. Vacuum:

+ 2000 m + 1000 m + 500 m 0 m

– 70 kPa – 525 mmHg – 79 kPa – 592 mmHg – 85 kPa – 638 mmHg – 90 kPa – 675 mmHg

5.

(Tolerance: +/- 15 %)

20 | Vacuum Assisted Delivery setup

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.