Medela Vario User manual

Vario

SUCTION PUMP

Instructions for use Gebrauchsanweisung

Mode d’emploi

Istruzioni per l’uso

Gebruiksaanwijzing Bruksanvisning

Käyttöohjeet

Bruksanvisning

Instrucciones de uso

Instruções de utilização

Vario 18 AC / DC

Table of contents

Congratulations ........................................................................................................................... 4

1 Warnings and safety instructions ...................................................................................... 5

Safety instructions .................................................................................................................. 7

2 Power supply and battery operation .................................................................................. 8

Battery low (only AC / DC versions) ......................................................................................... 8

Battery empty (only AC / DC versions) .................................................................................... 8

3 Description ............................................................................................................................ 8

Introduction ............................................................................................................................8

Intended use ........................................................................................................................... 8

Indications .............................................................................................................................. 9

Contraindications ....................................................................................................................9

Intended user.......................................................................................................................... 9

Intended Patient Population ................................................................................................... 9

Important note ........................................................................................................................ 9

4 Overview ............................................................................................................................. 10

Definition of vacuum ............................................................................................................. 10

Versions of the pump ........................................................................................................... 10

Front of the pump ................................................................................................................. 10

Bottom of device ...................................................................................................................11

Operating elements and battery status ................................................................................. 11

Acoustic indicator ..................................................................................................................11

On/off switch not c/i versions ................................................................................................11

On/off switch c/i versions ......................................................................................................11

5 Installation ........................................................................................................................... 12

Check initial delivery ..............................................................................................................12

6 Preparation for use ............................................................................................................ 13

Checks before use ................................................................................................................13

Assembly of the basic configuration ......................................................................................13

Assembly of the REUSABLE collection system .....................................................................14

Assembly of the DISPOSABLE collection system .................................................................15

7 Operating instructions ....................................................................................................... 16

Connect Vario to mains power ............................................................................................. 16

Check maximal vacuum for functional check ....................................................................... 16

Changing vacuum level..........................................................................................................17

Placing out of operation after use..........................................................................................17

8 Changing reusable jar ........................................................................................................ 18

9 Changing disposable liner ................................................................................................. 19

2 | Table of contents

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 servicing ..................................................................................................... 36

Warranty ............................................................................................................................... 36

Servicing / routine check ....................................................................................................... 36

24 Disposal ............................................................................................................................. 36

25 Technical documentation .................................................................................................. 37

Technical documentation / EMC ...................................................................................... 366

Table of contents | 3

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 applications and can be used for continuous operation. Contact us – we will be pleased to advise you.

4 | Congratulations

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).

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: U.S. Federal law restricts this device to sale by or on the order of a physician.

Subject to change.

Warnings and safety instructions | 5

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.

– Gastric suction: 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.

–

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 serious or fatal injury of the patient. – The Vario 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 Vario

and should be kept at least a distance 1ft (30 cm) away from the equipment. – 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 con si de rable danger of the patient.

Monitor the Vario frequently for opera ting 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 safe-

ty class lI (EN IEC 60601-1, A1, A2:1995), the safety tests are confined to visual inspec-

tion 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.

6 | Warnings and safety instructions

– 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.

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 | 7

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 (o nly AC / DC ver sions) 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

Contraindications

None known.

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.

Description | 9

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

10 | Overview

Suction port

Jar adaptors

Handle

Tubing holder

12 V DC

connector socket

(AC / DC ve rsions on ly)

Exhaust

Bottom of device

Operating elements and battery status

Specification plate

Fuse

Vacuum gauge

Vacuum regulator

Rechargeable battery indicator (only AC / DC ver sions)

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

Acoustic indicator

On/off switch not c/i versions

On/off switch c/i versions

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

Off: pump is switched off Intermittent:

pump is running in intermittent mode

Overview | 11

5 Installation

Check initial delivery

Check the delivery package of the Vario for completeness and general condition.

Vario portable version

Vario 8 AC 026.XXXX Vario 8 AC / DC 026.XX XX Vario 8 c/i AC / DC 026.XXXX Vario 18 AC 026.XXXX Vario 18 AC / DC 026.XX XX Vario 18 c/i AC / DC 026.XXXX

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

077. 0 931

5 x Disposable overflow protection / bacteria filter with Medela connections

077. 0 571

12 | Installation

Instructions for use

17 7. 26 04

+ 25 hidden pages