MEDAP VENTA Multi Care 16 Operating Instructions V13.01.03.23 May 2006

Copyright notice All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws. © Copyright MAQUET GmbH & Co. KG Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development. V13.01.03.23-05-2006

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

Table of contents

1 Introduction 1.1 Foreword... 1 1.2 Environment protection... 1 1.2.1 Packaging... 1 1.2.2 MAQUET products... 1 1.2.3 Disposal... 2 1.2.3.1 Within the European Trade Area... 2 1.2.3.2 Outside the European Trade Area... 2 1.3 How to use these Operating Instructions... 3 1.3.1 General... 3 1.3.2 Abbreviations... 3 1.3.3 Symbols... 3 1.3.3.1 Cross-references... 3 1.3.3.2 Actions and responses... 3 1.3.4 Definitions... 4 1.3.4.1 Design of safety notes... 4 1.3.4.2 Definition for other notes... 4 1.3.5 Symbols used... 5 1.4 VENTA MC 16 septic fluid suction pump... 7 1.4.1 VENTA MC 16 septic fluid suction pump / complete unit (REF 5752 2764)... 7 1.4.2 VENTA MC 16 septic fluid suction pump / basic equipment (REF 5752 2345)... 8 1.4.3 Pictorial view, septic fluid jar with hydrophobic bacteria filter... 9 1.4.4 Pictorial view, trolley... 10 1.4.5 Pictorial view, VENTA pump shelf for wall rail... 11 1.4.6 Pictorial view, VENTA carry bag... 12 1.4.7 Use in accordance with the intended purpose... 13 1.4.8 Applicable standards... 13 1.4.9 Intended purpose... 14 1.4.10 Connection description... 15 1.4.10.1 Vacuum connection tube... 15 1.4.10.2 Hydrophobic bacteria filter... 15 1.4.10.3 Septic fluid jar... 15 1.4.10.4 Suction tube... 16 1.4.10.5 Fingertip... 16 1.4.10.6 Utensil... 16 1.4.10.7 Equipment carrier interface... 16 1.4.10.8 Rinsing jar... 16 1.4.10.9 Application sets... 17 1.4.10.10Trolley... 17 1.4.10.11Pump shelf... 17 1.4.10.12Carry Bag... 17 1.4.11 Septic fluid suction pump variants... 18 2 2.1 2.2

Basic safety notes Personal safety notes... 19 Safety notes for the product... 21

3 3.1

Product description Mains operation... 22

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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Table of contents

4 4.1 4.2 4.3 4.4 4.5 4.6 4.6.1 4.6.2 4.6.3 4.7 4.8 4.8.1 4.8.2 4.8.3

First-time use General... 23 Mounting the overflow protection device... 24 Mount the septic fluid jar cap... 25 Lock the septic fluid jar in the septic fluid suction pump... 25 Mount the tubes and hydrophobic bacteria filter... 26 Equipment carrier interface... 27 Mount the septic fluid jar / rinsing jar (REF 5752 2312, REF 5752 2313)... 27 Attach holder (REF 5752 0187) for the Medi-Vac 1 / 1.5 l outer container... 27 Attach Serres outer container (REF 5752 2537)... 28 Connecting mains cable... 28 Mounting accessories... 29 Mount septic fluid suction pump on trolley... 29 Mount septic fluid suction pump on pump shelf... 30 Pack the septic fluid suction pump in the carry bag... 31

5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.3 5.4 5.5

Operation Functional check... 33 Extraction... 33 Operation... 35 Set the vacuum level... 36 Utensil... 37 Terminating the extraction process... 38 Empty the septic fluid jar... 38 Operation in the carry bag... 40

6 6.1 6.2

Malfunctions and troubleshooting General... 41 Replace mains fuses... 43

7 7.1 7.2 7.3 7.3.1 7.3.1.1 7.4 7.5

Cleaning and disinfection General... 44 Removing the septic fluid jar... 44 Cleaning... 46 General... 46 Cleaning... 47 Disinfection... 48 Disinfection procedures... 51

8 8.1 8.2 8.3 8.4

Maintenance and repairs General... 52 Maintenance... 52 Repairs... 52 Service hotline (inside Germany only):... 52

instructions VENTA Multi Care 16_ 5752 2434 ii Operating GA 5752 2434 EN 13

Table of contents

9 9.1 9.2 9.3 9.4 9.5 9.6 9.6.1 9.6.2 9.6.3 9.6.4

Technical specifications General... 53 Ambient conditions... 53 Dimensions and weight... 53 Technical specifications... 54 Vacuum in dependency on altitude... 54 Electromagnetic compatibility (EMC)... 55 Electromagnetic emission... 55 Electromagnetic interference resistance... 55 Electromagnetic interference resistance, non-vital equipment... 57 Recommended protective distances... 58

10 10.1 10.2

Approved accessories General accessories... 59 Application sets... 60

11 11.1 11.2 11.2.1 11.2.2

Spare parts General... 61 Spare parts... 61 Spare parts, septic fluid suction pump... 61 Spare parts, accessories... 61

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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instructions VENTA Multi Care 16_ 5752 2434 iv Operating GA 5752 2434 EN 13

Introduction Foreword

1

Introduction

1.1

Foreword Your facility has selected the leading-edge medical technology made by MAQUET. We sincerely appreciate the trust you have placed in us. MAQUET a member of the GETINGE Group, which consistently aims for pace-setting solutions in medical technology. MAQUET is regarded, around the world, as one of the leading suppliers of equipment for emergency rooms, operating theaters and intensive care units. Ever since the company was founded in 1838, MAQUET has been synonymous

1.2

Environment protection

1.2.1

Packaging

1

with innovations and technical progress in medical technology. The MEDAP septic fluid suction pumps made for OR and all-purpose use are high in performance and thus convincing in function. MEDAP septic fluid suction and drainage pumps are the basis for superior patient care at home, too. – Competence growing out of a sense of responsibility for patients, physicians and care givers.

The packaging is made of materials compatible with the environment. MAQUET will dispose of the packaging materials upon request. 1.2.2

MAQUET products MAQUET will take back used products or those which are no longer in service. Please contact your MAQUET factory representative for more detailed information.

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

1

1

Introduction Environment protection

1.2.3

Disposal

WARNING! Infection hazard This product is used in the treatment of patients. The product or some of its components may be contaminated after use. Clean and disinfect the product before disposal. 1.2.3.1

Within the European Trade Area This product is governed by the 2002/96/EEC Directive (Directive on Waste Electrical and Electronic Equipment). As a result of its registration pursuant to that Directive, disposal using the municipal collection

1.2.3.2

Outside the European Trade Area When disposing of this product, be sure to comply with the applicable national regulations on the handling and disposal of used equipment.

instructions VENTA Multi Care 16_ 5752 2434 2 Operating GA 5752 2434 EN 13

points for electrical equipment is not permitted. Please contact your MAQUET factory representative for more detailed information on correct and legal disposal.

Introduction How to use these Operating Instructions

1.3

How to use these Operating Instructions

1.3.1

General These operating instructions are provided to familiarize you with the features of this MAQUET product. They are subdivided into several chapters.

1.3.2

1

Please note: • Please read these operating instructions carefully and completely before using the product for the first time. • Always proceed in accordance with the information provided in these operating instructions. • Store these operating instructions in a location near the product.

Abbreviations EN EEC VDE

1.3.3

Symbols

1.3.3.1

Cross-references

European standard European Economic Community Verband der Elektrotechnik Elektronik Informationstechnik (Association for Electrical, Electronic & Information Technologies)

References to other pages in these Operating Instructions are identified with a double arrow symbol "". 1.3.3.2

Actions and responses The "⌧" symbol identifies an action taken by the user while the " " symbol identifies the reaction which this will induce in the system.

Example: ⌧ Turn on the light switch. Lamp lights up.

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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1

Introduction How to use these Operating Instructions

1.3.4

Definitions

1.3.4.1

Design of safety notes Pictogram

Descriptor

Text

DANGER!

Indicates a direct and immediate risk The text for the safety to persons, which may be fatal or re- note describes the type sult in most serious injury. of risk and how to avert it.

WARNING!

Indicates a potential risk to persons or property which may result in health hazard or grave property damage.

CAUTION!

Indicates a potential risk to property which may result in property damage.

Fig. 1: Design of safety notes

1.3.4.2

Definition for other notes Notes not referring to personal injury or property damage are used as follows: Pictogram

Descriptor

Reference to

NOTE

Supplementary assistance or further useful information.

ENVIRONMENT

Proper disposal.

Fig. 2: Definition for other notes

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Introduction How to use these Operating Instructions

1.3.5

1

Symbols used Symbol

Designation Marking for products which were developed and are marketed in compliance with the 93/42/EEC Medial Products Directive. Class IIa, IIb and III products are also marked with the identifying number for the notified body. Identification of devices incorporating a Type B applied part as defined in the IEC 60601-1 standard. Degree of protection against electrical shock. Labelling in compliance with the EN 980 standard. Symbol for "Serial number".

Marking in compliance with the IEC 60601-1 standard. Symbol for "Follow Operating Instructions".

Labelling as per the 2002/96/EC Directive (Directive on Waste Electrical and Electronic Equipment). Symbol for "Do not dispose of at the municipal collection points for used electrical equipment". Marking in compliance with the IEC 60601-1 standard. Symbol for ""Protection against dripping water"".

Labelling as per IEC 60601-1 standard. Symbol for "Alternating current".

Marking in compliance with the IEC 601-1. standard. Symbol for "ON".

Marking in compliance with the IEC 601-1. standard. Symbol for "OFF".

Labelling as per the IEC 60417-1 standard. Symbol for "Fuse".

Material designation for ABS plastic (Acrylonitrile-butadiene-styrene copolymer).

Fig. 3: Symbols (Part 1 of 2)

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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1

Introduction How to use these Operating Instructions

Symbol

Designation Packaging label. Symbol for "Keep dry".

Packaging label. Symbol for "Fragile! Handle with care".

Packaging label. Symbol for "Top".

Transportation label. Symbol for "Temperature limitations".

Transportation label. Symbol for "Relative humidity".

Transportation label. Symbol for "Atmospheric pressure".

Fig. 3: Symbols (Part 2 of 2)

instructions VENTA Multi Care 16_ 5752 2434 6 Operating GA 5752 2434 EN 13

Introduction VENTA MC 16 septic fluid suction pump

1.4

VENTA MC 16 septic fluid suction pump

1.4.1

VENTA MC 16 septic fluid suction pump / complete unit (REF 5752 2764)

1

2

1

4 3 5

6 9

11

10

12 13

7

14

8

18

15

17

16

Fig. 4: VENTA MC 16 septic fluid suction pump / complete unit (REF 5752 2764) 1 Operating panel 2 OFF switch 3 Operating status display 4 ON switch 5 Septic fluid jar with cap 6 VENTA MC 16 septic fluid suction pump 7 Regulating knob 8 Vacuum gauge 9 Connection of equipment mount

10 Mains cable 11 Fingertip 12 Hydrophobic bacterial filter 13 Suction tube 14 Connection tube 15 Connector nipple on the pump side 16 Equipment socket 17 Type plate 18 Rinsing fluid container

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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1 1.4.2

Introduction VENTA MC 16 septic fluid suction pump

VENTA MC 16 septic fluid suction pump / basic equipment (REF 5752 2345)

1

2

3

4

5

8

6

7

9 10

14

12

11

13

Fig. 5: VENTA MC 16 septic fluid suction pump / basic unit (REF 5752 2764) 1 Operating panel 2 OFF switch 3 Operating status display 4 ON switch 5 VENTA MC 16 septic fluid suction pump 6 Vacuum gauge 7 Regulating knob

instructions VENTA Multi Care 16_ 5752 2434 8 Operating GA 5752 2434 EN 13

8 Connection of equipment mount 9 Hydrophobic bacterial filter 10 Connector nipple on the pump side 11 Equipment socket 12 Type plate 13 Connection tube 14 Mains cable

Introduction VENTA MC 16 septic fluid suction pump

1.4.3

1

Pictorial view, septic fluid jar with hydrophobic bacteria filter

1

7

2 3 4

6 5

Fig. 6: Pictorial view, septic fluid jar 1 Connector nipple on the patient side 2 Septic fluid jar cap 3 Float cage (mechanical overflow protection) 4 Float (mechanical overflow protection)

5 Septic fluid jar 6 Fingertip recess (for removing the septic fluid jar cap) 7 Hydrophobic bacteria filter

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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1 1.4.4

Introduction VENTA MC 16 septic fluid suction pump

Pictorial view, trolley 1 2

3

4

5

Fig. 7: Pictorial view, trolley 1 Locating pin 2 Screw with star knob 3 Tube holder

instructions VENTA Multi Care 16_ 5752 2434 10 Operating GA 5752 2434 EN 13

4 Equipment rail 5 Castor brake

Introduction VENTA MC 16 septic fluid suction pump

1.4.5

1

Pictorial view, VENTA pump shelf for wall rail

1 2

3

Fig. 8: Pictorial view, pump shelf for wall rail 1 Locating pin 2 Screw with star knob

3 Mounting screw

The VENTA pump shelf for the wall rail will be referred to below simply as "pump shelf".

Operating instructions VENTA Multi Care 16_ 5752 2434 GA 5752 2434 EN 13

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1 1.4.6

Introduction VENTA MC 16 septic fluid suction pump

Pictorial view, VENTA carry bag

1

2

3 3 4 5

6 13

7 8 9

5

12

6

8 10 11

Fig. 9: Pictorial view, carry bag 1 Opening for septic fluid suction pump handle 2 Upper section 3 Tab 4 Side panel 5 Shoulder strap 6 Reflector strip 7 Opening for septic fluid suction pump ventilation grille

The VENTA carry bag will be referred to only as carry bag below.

instructions VENTA Multi Care 16_ 5752 2434 12 Operating GA 5752 2434 EN 13

8 Front zipper 9 Inside front pocket 10 Front side 11 Inside front pocket zipper 12 Opening for septic fluid suction pump power supply 13 Shoulder strap attachment ring

Introduction VENTA MC 16 septic fluid suction pump

1.4.7

Use in accordance with the intended purpose Product As per Annex IX of the 93/42/EEC Medical Products Directive, this unit is a Class IIa item. As prescribed by that directive, only persons skilled in the use of the product and medical personnel may use this product, provided that they have been instructed by an authorised individual on the use of the product. This product is to be used exclusively for human medicine. When employed in a commercial or business use this product shall be entered in the inventory.

1.4.8

1

Accessories Accessories or combinations of accessories may be utilised only when and as indicated in these Operating Instructions. Other accessories, combinations of accessories and consumable items may be used only if they have a valid certification, are intended expressly for the particular use and will not adversely affect performance, the prescribed ambient conditions or safety requirements.

Applicable standards The product satisfies the basic requirements set forth in Annex I to the 93/42/EEC Directive drafted by the Medical Products Council (Medi-

cal Products Directive) as well as the applicable national (German) codes and the Medical Products Act in Germany.

The applicable standards include the following: • EN 837-1: 1997-02 Pressure measurement devices Part 1: Bourdon tube pressure gauges – dimensions, metrology, requirements and testing • EN ISO 10079-1: 2000-03 Medical suction equipment Part 1: Electrically powered suction equipment • EN 60601-1: 1996-03 Medical electrical equipment Part 1: General requirements for safety • EN 60601-1-2: 2002-10 Medical electrical equipment 2. Collateral standard: Electromagnetic compatibility – Requirements and tests • EN 12218: 2002- 07 Rail systems for supporting medical equipment • EN ISO 14971: 2001-03 Medical devices – Application of risk management to medical devices

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1 1.4.9

Introduction VENTA MC 16 septic fluid suction pump

Intended purpose The VENTA MC 16 septic fluid suction pump is a portable, electrically powered suction pump. The product is designed for temporary duty of maximum 30 minutes and suitable for low flow and high vacuum. The VENTA MC 16 septic fluid suction pump is powered by 230 V / 50 Hz. The product is an active medical product for therapeutic treatment. The VENTA MC 16 septic fluid suction pump is intended for the aspiration of patient secretion, blood, vomit or serous fluids from natural and artificial orifices and is particularly suited for bronchoaspiration (nasal and oral aspiration). The VENTA MC 16 septic fluid suction pump is not invasive and cannot be implanted. Is has no direct application at human organs. The VENTA MC 16 septic fluid suction pump may only be used in combination with a septic fluid jar, an overflow protection device and a hydrophobic bacterial filter. A sterile extraction catheter and fingertip are always to be used for extractions. The VENTA MC 16 septic fluid suction pump has applications in the hospital environment, in general medical practices, in old people's and nursing homes as well as in military ambulance service. The unit is used by medical personnel who, on the basis of their professional experience and instruction in safety matters, are able to evaluate their activities and recognize potential hazards associated with the work. The VENTA MC 16 septic fluid suction pump may be used in home care by patients and their relatives only after appropriate instructions by medical experts.

The VENTA MC 16 septic fluid suction pump may only be used with accessories which has MAQUET approval for the combination according to accessory list or comply with the requirements of the connection description. The VENTA MC 16 septic fluid suction pump may not be used for the following purposes or under the following conditions: • • • • • • • • • • • • • • • • •

•

during surgery, for drainage, in pediatrics, in neonatology, by rescue services for operation without overflow protection device, for operation without a hydrophobic bacterial filter, for extraction without a fingertip, for operation without a septic fluid jar, for extraction of flammable, caustic or explosive liquids or gases, outside the intended ambient conditions (Page 53), in areas subject to explosion hazard (anesthesia gases ), in a areas subject to splashed water, with accessories which have not been approved by MAQUET, by unsupervised children, while the unit is being carried, after rinsing the VENTA MC 16 septic fluid suction pump with water or dipping it in water, if the septic fluid jar or its cap has come into contact with strong acids or bases.

In the following the VENTA MC 16 septic fluid suction pump is referred to as septic fluid suction pump.

instructions VENTA Multi Care 16_ 5752 2434 14 Operating GA 5752 2434 EN 13