Vario 18 Instructions for Use Dec 2014

EN 10 Troubleshooting... 20 Motor not running... 20 Insufficient vacuum... 20 No LED lit (AC / DC version only)... 20 LED lit up (AC / DC version only)... 20 LED blinks slowly (AC / DC version only)... 20 LED blinks rapidly (AC / DC version only)... 20 11 Replacing defective fuse... 21 12 Setting interval times... 22 13 Replacing the QuatroFlex... 23 14 Replacing the rechargeable battery... 24 15 Battery data and test... 25 Duration of pumping...25 Charging time (charged up to 100 %)...25 Testing the rechargeable battery...25 16 Battery calibration... 26 Calibrating NiMH rechargeable battery...26 Storage of the rechargeable battery...26 17 Filter test... 27 18 Cleaning guidelines... 28 General notes...28 Medela recommended surface cleaning agents for pump housing...28 Water...28 Cleaning / disinfection machines ...28 Disposable products...28 19 Accessories overview... 30 20 Accessories legend... 31 21 Technical specifications... 33 22 Signs and symbols... 34 23 Warranty and maintenance... 36 Warranty... 36 Maintenance / routine check... 36 24 Disposal ... 36 25 Technical documentation... 37 Technical documentation / EMC... 366

Table of contents

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Congratulations By choosing the Vario, you have acquired a high-quality suction pump which is adaptable to your needs. The QuatroFlex suction aggregate is the innovative continuation of the proven Medela piston / cylinder system. 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 Vario ideally suited to a wide range of medical a ­ pplications and can be used for continuous operation. Contact us – we will be ­pleased 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 Vario 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 Vario is used in combination with the original Medela accessories (collection system, tubings, filters etc. – see chapters 19 / 20). The Vario 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 Vario. 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 Vario 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. – For patients for whom a breakdown of the device can lead to a critical situation (e.g. patients with acute dyspnoea or severe catarrhal congestion), a replacement device must always be available. – 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 Vario. Failure to read and follow all instructions in this manual prior to use may result in s­ erious 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 Vario pump. A safety distance of min. 3.3 ft (1 m) to the Vario 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 Vario frequently for opera­ting status. Safety related tip – The Vario suction pump is Magnetic Resonance (MR) unsafe. Do not take the pump into the MR environment. – For safety tests, it is assumed that the device is serviced and repaired throughout its service life in accordance with the service manual. Because the Vario is a device of safety class lI (EN IEC 60601-1, A1, A2:1995), the safety tests 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 Vario 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.

6 | Warnings and safety instructions

EN Safety instructions – The Medela Vario 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. – 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 place the power supply cord around your neck. – 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. – Do not place a 2 l suction jar in the lateral adaptor. – The overflow protection / bacteria filter protects the pump against overflow. Caution: Suctioning is interrupted when the filter is wet / moist or clogged. Test the filter before each use and during use periodically (see chapter 17). These instructions for use must be kept for later reference.

Warnings and safety instructions

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2 Power supply and battery operation The Vario 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. If the Vario AC / DC versions are running continuously, a maximum of 30 minutes of battery time is expected before it is necessare to recharge. If the Vario AC / DC version is not in use, the battery must be calibrated every 60–90 days. Battery low (only AC / DC versions) During battery operation a slow blinking of the LED indicator and an acoustic signal (beep - beep - beep) indicates, that the rechargeable battery is soon discharged. The function of the Vario is maintained for 10 minutes (20 minutes Vario low vacuum versions), but the battery must be recharged as soon as possible. Battery empty (only AC / DC versions) As soon as the rechargeable battery is empty, the pump comes to a stop. The proper function of the pump is no longer maintained. The rechargeable battery must be recharged.

3 Description Introduction The Vario is a high-quality suction pump. It is powered by the well-proven QuatroFlex system and guarantees 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 The Vario 8 / 18 / ci suction pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient’s airway or respiratory support system, either during surgery or at the patient’s bedside. Generally the Vario 8 / 18 / ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal suctioning either in «constant» or «intermittent» mode. Please make sure you have a correct Vario version for the required application.

8 | Power supply and battery operation | Description

EN Indications Gastric suction: Only with Vario 18 c / i: When the device is used for gastric suction, the patient’s condition and correct functioning of the pump (on the basis of acoustic and visual signs) must be checked at least once every four hours. ENT indications: For patients for whom a breakdown of the device can lead to a critical situation (e.g. patients with acute dyspnoea or severe catarrhal congestion), a replacement device must always be available. Contraindications Not suitable for setting at a low vacuum, as needed for example for thoracic drainage without specialized accessories. Intended user The Vario 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 Vario 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 three years.

Description

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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).

Versions of the pump

Vario 8 AC

Vario 8 AC / DC

Vario 8 c/i AC / DC

Vario 18 AC

Vario 18 AC / DC

Vario 18 c/i AC / DC

Front of the pump

Handle Suction port

Tubing holder

Jar adaptors

12 V DC connector socket (AC / DC versions only)

Exhaust

10 | Overview

EN Bottom of device

Specification plate

Fuse

Operating elements and battery status

Vacuum gauge Vacuum regulator Rechargeable battery indicator (only AC / DC versions)

Acoustic indicator

On/off switch not c/i versions

not lit

Battery is fully charged

lit up

– Battery is being charged – Pump is connected to the mains

blinks slowly

Battery is soon empty

blinks rapidly

Battery is defective

During battery operation an acoustic signal (beep - beep beep) indicates that the rechargeable battery is soon discharged.

On: pump is running Off: pump is switched off Constant: pump is running in constant mode

On/off switch c/i versions Off: pump is switched off Intermittent: pump is running in intermittent mode

Overview

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5 Installation Check initial delivery

Check the delivery package of the Vario for completeness and general condition. Vario portable version Vario 8 AC Vario 8 AC / DC Vario 8 c/i AC / DC Vario 18 AC Vario 18 AC / DC Vario 18 c/i AC / DC

026.XXXX 026.XXXX 026.XXXX 026.XXXX 026.XXXX 026.XXXX

Silicone Tubing ø 7 x 12 mm, 25 cm with 2 coupling pieces 077.0931

5 x Disposable overflow protection / bacteria filter with Medela connections 077.0571

Instructions for use 177.2604

12 | Installation

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 Vario 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).

before use 6.1 Checks – Check the Vario 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 Vario delivery package. – Only for AC / DC versions: make sure that the rechargeable battery is calibrated according to chapter 16. – 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 several times before actual use.

of the 6.2 Assembly basic configuration

1.

1.1 Attach the overflow protection bacteria filter to the Vario 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.

2. Attach all necessary accessories according to your needs. See the system overview for more details.

Preparation for use

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of 6.3 Assembly the REUSABLE

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

collection system 2.

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

positions for jars: 2.1 2.2

3.

3.1 Attach the lid to the jar. 3.2 Lock with the two lid clamps.

3.1

3.2

3.2

4.

4.1 Attach the jar to the Vario. 4.2 Connect tubing to the filter. 4.3 Connect tubing to the lid of the jar (marked with «vacuum»).

4.2 4.3

4.1

5.

14 | Preparation for use

5.1 Connect patient tubing to the lid of the jar (marked with «patient»).

EN of 6.4 Assembly the DISPOSABLE

1. If you use a REUSABLE collection system proceed with step 6.3.

collection system 2.

2.1 Attach the Vario jar adapter to the Vario.

3.

3.1 Choose the 1.5 l size (yellow code) for the Vario. 3.2 Prepare and insert corresponding liner size (yellow) 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.

4.2

4.3

4.1 Attach the jar to the Vario. 4.2 Connect tubing to the filter. 4.3 Connect tubing to the jar. The tubing connector is on top of the jar.

4.1

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).

Preparation for use

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7 Operating instructions CAUTIONS The Vario is to be set up in such a way, that a separation from the mains supply can be easily managed. Vario to 7.1 Connect mains power

1. Check the pump before use following the instruction in chapter 6.1. 2. All versions: if the pump is connected to a fixed mains socket: or AC / DC versions: if the pump is operated with a 12 V DC power source:

Plug in the mains plug of the power cord to a fixed mains socket. Connect the optional 12 V DC connection cable to the socket on the side of the pump and connect it to the 12 V DC power source.

or AC / DC versions: if the No connection to a power pump is operated with the source is needed. Make rechargeable battery: sure that the battery was charged for five hours.

maximal 7.2 Check vacuum for

1.

functional check

16 | Operating instructions

or

1.1 Switch on the Vario. The pump will start running. Caution: c / i versions must be switched on in «constant» mode.

2.

2.1 Press and 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. See chapter 10 if the maximum vacuum is not reached.

EN Specifications: Altitude above sea level:

Vario 8 / Vario 8 c/i Max. Vacuum: low vacuum

Vario 18 c/i Max. Vacuum: medium vacuum

Vario 18 Max. Vacuum: high vacuum

+ 2000 m + 1000 m + 500 m 0m

– 7.0 kPa – 7.9 kPa – 8.5 kPa – 9.0 kPa

– 43 kPa – 48 kPa – 51 kPa – 55 kPa

– 59 kPa – 66 kPa – 70 kPa – 75 kPa

(Tolerance +/- 10 %)

vacuum 7.3 Changing level

1.

out of 7.4 Placing operation after use

1.

1.1 Clamp patient tubing 1.2 Push and turn vacuum regulator to select the correct vacuum according to the particular application. 1.3 Check vacuum gauge for setting.

or

1.1 Switch the on / off switch of the Vario to position «0» (c/i - versions: «Off»).

2. If the pump is connected Disconnect the mains plug to a fixed mains socket: from the fixed mains socket. or If the pump is connected Disconnect the 12 V DC to a 12 V DC power source: plug from the 12 V DC power source. 3. Clean and desinfect the Vario. See chapter 18.

Operating instructions

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8 Changing reusable jar 1.

or

1.1 Switch the on / off switch of the Vario to position «0» (c/i - versions: «Off»). 1.2 Remove patient and vacuum tubings from the lid.

2.

2.1 Remove full jar from the Vario.

3.

3.1 Prepare new jar and unpack it. 3.2 Secure new jar to the Vario 3.3 Reconnect vacuum tubing and new patient tubing firmly.

4. Empty jar and dispose of patient tubing in accordance with local guidelines and inhouse guidelines. 5. Switch on the Vario. The pump will start running. 6. Set vacuum according to the particular application. See chapter 7.3.

18 | Changing reusable jar

EN

9 Changing disposable liner WARNINGS Disposable liners are not intended to be reprocessed. Reprocessing could cause loss of mechanical, chemical and / or biological characteristics. 1.

1.1 Remove patient tubing with colored angle piece from lid. 1.2 Plug patient port.

1.5 l 2.

3.

or

2.1 Switch the on / off switch of the Vario to position «0» (c/i - versions: «Off»). Reduce vacuum to minimum by pressing and turning vacuum regulator to the left. 3.1 Remove full liner from the jar.

4. Dispose of the liner and patient tubing in accordance with local guidelines and inhouse guidelines. 5. Prepare new liner, unpack it and insert it in the jar. Press down lid. 6.

6.1 Connect new patient tubing firmly.

7. Switch on the Vario. The pump will start running. 8. Set vacuum according to the particular application. See chapter 7.3. Changing disposable liner

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10 Troubleshooting Motor not running Check if: – the Vario is switched on. – the mains voltage is correct and if the mains plug is inserted correctly into the fixed mains socket. – the internal battery is charged (only AC / DC version under battery operation) – the fuse on the bottom of the Vario is not defective. For replacing the defective fuse see chapter 11. Insufficient vacuum Check if: – the vacuum regulator is set correctly. – the tubings are 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 as shown under 6.3a/2.2. – the suction jar / lid have no cracks, brittle areas, discolouration. Replace if necessary. – the disposable system has no cracks, brittle areas, discolouration. Replace if necessary. – filter is not clogged. To test if the filter is clogged see chapter 17. – the QuatroFlex is defective. To replace the QuatroFlex see chapter 13. No LED lit (AC / DC version only) The rechargeable battery is fully charged. LED lit up (AC / DC version only) – The rechargeable battery is being charged. – The pump is connected to the mains. LED blinks slowly (AC / DC version only) The rechargeable battery is soon empty. LED blinks rapidly (AC / DC version only) The rechargeable battery is defective. For replacing the defective battery see chapter 14.

20 | Troubleshooting

EN

11 Replacing defective fuse WARNINGS Before replacing the fuse, pull the mains plug from Vario out of the fixed mains socket.

1. Disconnect the Vario from the mains. 2.

2.1 Open (turn left) the fuse holder on the bottom of the Vario.

3. Replace the defective fuse(s). Make sure that the technical specification are corresponding. AC-versions: AC / DC-versions:

T 0.8 AL, 5 x 20, 230–240 V T 1.25 AL, 6.3 x 20, 120 V T 1.0 AL, 5 x 20, 100–240 V

4.

4.1 Close (push back and turn right) the fuse holder.

5. Reconnect the Vario to the mains again. 6. Switch on the Vario again.

Replacing defective fuse

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