YUNO OTN 1433.01XX Operating Instructions V08.05 Nov 2013

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 Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development. V08.05 22-11-2013

1433.01XX GA 1433.01 EN 08

Table of contents

1 Introduction 1.1 Foreword... 1 1.2 How to use these operating instructions... 1 1.2.1 General... 1 1.2.2 Abbreviations... 1 1.2.3 Symbols... 2 1.2.3.1 Order number... 2 1.2.3.2 Cross-references... 2 1.2.3.3 Actions and responses... 2 1.2.3.4 Buttons and menus... 2 1.2.4 Definitions... 3 1.2.4.1 Design of safety notes... 3 1.2.4.2 Design for other notes... 3 1.2.4.3 Definition for 3-dimensional coordinate system... 4 1.2.4.4 Definition of slope and tilt... 4 1.2.4.5 Definition of permissible overall load... 5 1.2.4.6 Definition of protrusion... 5 1.2.4.7 Definition of area prone to explosion, Zone AP-M... 5 1.2.4.8 Definition Positioning- / Transporting... 5 1.2.4.9 Definition of travelling forwards / backwards... 6 1.2.4.10 Definition of patient orientation... 7 1.2.5 Symbols used... 8 1.3 Disposal... 10 1.3.1 General... 10 1.3.2 Packing... 10 1.3.3 Padding... 10 1.3.4 Rechargeable batteries/ Batteries... 10 1.3.5 MAQUET products... 10 1.3.6 Used electrical equipment... 10 1.3.6.1 Within the European Economic Community... 10 1.3.6.2 Outside the European Economic Community... 10 1.4 Overview... 11 1.5 Basic requirements... 12 1.5.1 Use in accordance with the intended purpose... 12 1.5.2 Applicable standards... 12 1.5.3 Intended purposes... 13 1.5.3.1 Mobile operating table YUNO... 13 1.5.3.2 Variants... 13 1.5.3.3 Product features... 13 1.5.3.4 Hand controls... 14 1.5.3.5 Side rails... 14 2 2.1 2.2 2.3 2.4

Basic safety instructions Personal safety notes... 15 Safety notes for the OR table... 19 Safety notes regarding the use of accessories... 20 Safety notes regarding padding... 22

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Table of contents

3 3.1 3.2 3.3 3.4 3.4.1 3.4.2 3.5 3.6 3.7 3.7.1 3.7.2 3.7.3 3.7.3.1 3.7.4 3.7.5 3.7.5.1 3.7.6 3.7.6.1 3.7.6.2 3.7.7 3.7.7.1 3.7.7.2 3.7.8 3.8

Operation and use General... 23 Acoustic signals issued by the OR table... 23 Set up the equipotential bonding... 24 Mains operation / battery operation... 25 Charge batteries (mains operation)... 25 Battery operation... 26 Connecting the service mounting point... 27 Attaching the hand control to the side rail... 28 Mechanical adjustments... 29 Accessory recognition... 29 Mounting and removing table width extensions (1001.75A0/76A0)... 32 Mounting/removing the head rest... 33 Mounting and removing the head rest using the head rest adapter (1130.81A0)... 33 Mounting and removing the extension plate (1131.31XX)... 35 Seat plate extension... 36 Mounting and removing the seat plate extension (1131.55XX)... 36 Leg plates... 37 Mounting and removing the pair of leg plates (1133.53BC)... 37 Mounting and removing the leg plate (1133.58BC)... 38 Basic table top... 39 Mounting/removing the standard plate... 39 Mounting / removing the extension plate (1433.66XC)... 40 Mounting and removing the filler pieces for the pair of leg plates (1433.50AC)... 41 Padding... 42

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4 4.1 4.2 4.2.1 4.2.2 4.2.2.1 4.2.2.2 4.2.2.3 4.3 4.3.1 4.3.2 4.3.3 4.4 4.4.1 4.4.1.1 4.4.1.2 4.4.2 4.4.2.1 4.4.2.2 4.4.2.3 4.4.2.4 4.4.2.5 4.4.2.6 4.4.2.7 4.4.2.8 4.4.2.9 4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 4.5.5.1 4.5.5.2 4.5.5.3 4.5.6 4.5.7 4.5.7.1 4.5.7.2 4.5.7.3 4.5.7.4 4.5.8 4.5.8.1 4.5.8.2 4.5.8.3 4.5.8.4 4.5.8.5 4.5.9 4.5.9.1 4.5.9.2 4.5.9.3 4.6 4.6.1 4.6.1.1 4.6.1.2 4.6.2

Hand controls General... 43 Override control panel... 44 Overview of override control panel... 45 Overview of displays... 46 Overview of status display mains operation... 46 Overview of the status display for battery operation... 46 Overview of change display LOCK / UNLOCK... 47 Corded hand controls... 48 Foot switch (1009.81G0/G1/G2)... 48 Corded hand control (1433.90A0)... 48 Connecting corded hand controls... 49 IR remote control (1433.91A0)... 50 Control buttons and functions... 50 Switching on the illumination... 51 [Leg side] selector key... 52 Special features of the IR remote control (1433.91A0)... 53 General... 53 Acoustic signals... 53 IR code... 53 Transmission power... 53 Charging unit (1009.70A0) / Charging station (1009.71A0)... 54 Mobile charger (1009.70A0)... 54 Stationary charging station... 55 Inserting the IR remote control... 56 Removing the IR remote control... 56 Display... 57 General... 57 Display design... 57 Symbols for status bar... 58 Symbols for the navigation bar... 59 Standard patient positions... 60 FLEX / REFLEX position... 60 BEACH CHAIR / BACK HORIZONTAL position... 61 NORMAL/REVERSE patient orientation... 62 Menu item [System information]... 62 [Patient positions] menu... 63 Select the patient position function... 63 Moving into patient position... 64 Saving the patient position... 64 Editing names... 65 [Settings] menu... 66 Selecting the [Settings] menu... 66 Activating and deactivating the operating table lock... 66 Activating and deactivating the table top lock... 67 Switching illumination ON / OFF... 68 Switching the signal tone at the column ON / OFF... 68 [Fast memory] menu... 69 Selecting the function... 69 Move into patient position... 69 Saving patient position... 70 Adjustment functions... 71 Moving/immobilising the OR table... 71 Moving the OR table using(UNLOCK)... 72 Standing the OR table on the floor (LOCK)... 73 Lowering / raising the patient (table top)... 73 1433.01XX GA 1433.01 EN 08

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Table of contents

4.6.3 4.6.4 4.6.5 4.6.6 4.6.7 4.6.8 4.7 4.7.1 4.7.2

Motorised adjustment of the table top... 74 Aligning the patient horizontally... 75 Inclining the patient... 76 Tilting the patient... 77 Deactivating the lock function temporarily... 78 Aligning the leg plate horizontally... 78 Explanation of instructions for use... 79 Height for operating table lock... 79 Risk of collision with traction bars... 79

5 5.1 5.1.1 5.2 5.3

Display notes General... 80 Structure of display notes... 80 Notes on operation / special notes on operation... 80 Warning notes / Status messages... 82

6 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.1.8 6.1.9 6.2 6.2.1 6.2.2 6.2.3 6.3 6.3.1 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.4.9 6.4.10

Extension positioning Assembling the extension device... 85 Mounting the extension plate (1433.66XC)... 85 Mounting the traction bars... 85 Mounting the pair of leg plates (1433.50AC)... 86 Mounting the height adjustment... 86 Mounting the screw tension device... 87 Mounting the countertraction post... 87 Fixing patient's leg in the extension shoe... 88 Mounting the extension shoe (1003.67X0)... 88 Removing the pair of leg plates... 89 Setting the extension device... 89 General... 89 Adjusting the height of the extension device... 90 Abducting the extension device... 91 Setting the screw tension device... 92 Setting the internal / external rotation of the extension shoe... 93 Detaching the extension device... 94 Releasing the traction of the screw tension device... 94 Aligning the traction bars... 94 Mounting the pair of leg plates (1433.50AC)... 95 Removing the extension shoe (1003.67X0)... 95 Removing the countertraction post... 96 Removing the screw tension device... 96 Removing the gas strut assisted height adjustment... 97 Removing the traction bars... 97 Removing the leg plates... 98 Removing the extension plate... 98

7 7.1 7.1.1 7.1.2 7.2 7.2.1 7.2.2 7.3 7.4

Patient positioning Table top configuration for an overall load of up to 155 kg... 100 NORMAL patient orientation... 101 REVERSE patient orientation... 102 Table top configuration for an overall load of 155 kg to 250 kg... 103 NORMAL patient orientation... 104 REVERSE patient orientation... 105 Table top configuration for an overall load of 250 kg to 454 kg... 106 Special accessories YUNO OTN... 108

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8 8.1 8.2 8.2.1 8.2.2 8.3 8.3.1 8.3.2 8.3.3 8.4 8.5 8.6

Cleaning and disinfection General... 109 Cleaning... 111 General... 111 Cleaning procedure... 112 Disinfection... 112 General... 112 Suitable disinfectants... 113 Disinfection procedure... 114 Stainless steel surfaces... 114 Padding... 114 Cleaning and manual disinfection of the swivel castors... 114

9 9.1 9.2 9.2.1 9.2.2 9.3 9.4

Maintenance Visual and functional inspections... 115 Malfunctions and troubleshooting... 117 General... 117 Troubleshooting... 117 Inspection and Maintenance... 118 Repair... 118

10 10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.8.1 10.8.2 10.9 10.10

Technical specifications General specifications... 119 Ambient conditions... 119 Electrical specifications... 119 Weights... 120 Dimensions... 120 Inclination... 121 Tilt... 121 Motorised joint... 122 REVERSE mounting point... 122 NORMAL mounting point... 122 Radiolucent area... 123 Extension device... 124

11 11.1 11.2 11.2.1 11.2.2 11.2.3 11.3 11.3.1 11.3.2 11.3.3 11.4 11.4.1 11.4.2 11.5 11.5.1 11.5.2 11.5.3

Approved accessories General... 125 Accessories for head-end mounting point... 126 Maximum overall load of 155 kg... 126 Maximum overall load of 250 kg... 127 Maximum overall load of 454 kg... 128 Accessories for NORMAL mounting point (back plate mounting point)... 129 Maximum overall load of 155 kg... 129 Maximum overall load of 250 kg... 135 Maximum overall load of 454 kg... 140 Accessories for REVERSE mounting plate (leg plate mounting point)... 141 Maximum overall load of 155 kg... 141 Maximum overall load of 250 kg... 143 YUNO accessories... 145 YUNO accessories, overall load 250 kg... 145 Side rail accessories... 145 Hand controls... 146

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Table of contents

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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 is a member of the GETINGE group which is consistently directing its attention to pioneering medico-technical solutions.

1.2

How to use these operating instructions

1.2.1

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

1.2.2

1

MAQUET is one of the world’s leading suppliers for emergency rooms, operating rooms and intensive care units. MAQUET has been standing for innovation and advance in medical technology ever since it was founded in 1838. Solutions relevant to the needs of practice and customer-oriented services optimise working cycles and boost economy in hospitals – all to the benefit of the patient.

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 contained herein. • Store these operating instructions in a location near the product.

Abbreviations EMC EN EU IR INT IPS LED OR table PUR SELV SFC

Electromagnetic compatibility European standard European Economic Community Infrared Intermittent Internal Power Source Light Emitting Diode Operating table Polyurethane integral foam Safety Extra Low Voltage Soft Foam Core (special foam core)

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Introduction How to use these operating instructions

1.2.3

Symbols

1.2.3.1

Order number An "X" in the order number (e.g. 1122.33X4) is a placeholder for a number of variants.

1.2.3.2

Cross-references References to other pages in these operating instructions are identified with a double arrow symbol "".

1.2.3.3

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

1.2.3.4

Example:  Turn on the light switch.  Lamp lights up.

Buttons and menus Buttons and menus are enclosed in square brackets.

Example:  Press the [DOWN] button in the [Operation]

menu.

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Introduction How to use these operating instructions

1.2.4

Definitions

1.2.4.1

Design of safety notes Pictogram

Descriptor

1

Text

DANGER!

Indicates a direct and immediate risk The text for the safety to persons, which may be fatal or note describes the type result 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

1.2.4.2

Design 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: Design for other notes

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Introduction How to use these operating instructions

1.2.4.3

Definition for 3-dimensional coordinate system Reference

X axis

Y axis

Z axis

Product

Longitudinal direction

Lateral direction

Height

Patient

Longitudinal

Transverse

Sagittal

Neutral

Horizontal

Horizontal

Vertical

Fig. 3: Definition of terms for the 3-dimensional coordinate system 1 Frontal plane (horizontal plane) 2 Sagittal plane

1.2.4.4

3 Transverse plane

Definition of slope and tilt

Fig. 4: Definition of slope and tilt 1 Reverse Trendelenburg (foot down) 2 Trendelenburg (head down)

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3 Tilt 4 Slope

Introduction How to use these operating instructions

1.2.4.5

Definition of permissible overall load The "permissible overall load" results from adding up patient weight, side rail accessory weight and positioning aids. The "permissible overall load" is the load which may be put on the table top.

1.2.4.6

Restrictions might result from the components table top and transporter for which other overall loads may be valid, or from special patient positions.

Definition of protrusion Protrusion is the gap between the mounting point(s) of a table top to the relevant outer edge of the table top components (e.g. head rest, leg plates) applied to the front.

1.2.4.7

1

The maximum protrusion of a table top may not be exceeded.

Definition of area prone to explosion, Zone AP-M The medical environment is designated as "Zone AP-M" (1).

1

Fig. 5: Area prone to explosion, Zone AP-M

1.2.4.8

Definition Positioning- / Transporting When moving, a distinction is made between moving the mobile operating table with a patient and without a patient.

Transporting Transporting refers to the process of moving the mobile operating table without a patient in the operating room.

Positioning Positioning refers to the process of moving the mobile operating table with a patient within the operating room.

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Introduction How to use these operating instructions

1.2.4.9

Definition of travelling forwards / backwards The following definition applies to motor-powered motion: • forwards (1) • backwards (2)

2

Fig. 6: Travelling forwards / backwards

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Introduction How to use these operating instructions

1.2.4.10

1

Definition of patient orientation

WARNING! Risk of injury! Incorrectly adjusted patient orientation may cause adjustment of the operating table in a direction that was not intended. Check the correct patient orientation prior to making any adjustments. The patient orientation is indicated in the status bar on the display on the hand control. The patient orientation depends on the position of the patient on the table top with regard to the operating table base (1). NORMAL patient orientation The upper part of the patient's body is located above the longer section of the operating table base (1).

1

Fig. 7: NORMAL patient orientation

REVERSE patient orientation The legs are located above the longer section of the operating table base (1).

1

Fig. 8: REVERSE patient orientation

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1 1.2.5

Introduction How to use these operating instructions

Symbols used Symbols are attached to products, type plates and packaging. Symbols

Identification Labelling for Class I products, developed and marketed in compliance with Medical Device Directive 93/42/EU.

Labelling in compliance with the ISO 15223-1 standard. Symbol for "Product number"

Labelling in compliance with the ISO 15223 -1 standard. Symbol for "Serial number".

Designation in compliance with the ISO 15223-1 standard. Symbol for "Name and address of the manufacturer as well as date of manufacture". Labelling in compliance with the IEC 60601-1 standard. Symbol for "Follow Operating Instructions".

Labelling in compliance with the IEC 60601-1 standard. Symbol for "Observe the accompanying documents".

Symbol for "Observe operating instructions".

Labelling for devices incorporating a Type B applied part as defined in the IEC 60601-1 standard. Degree of protection against electric shock. Labelling in compliance with the IEC 60601-1 standard. Symbol for "Class II".

Labelling as per 2002/96/EU Directive (Directive on Waste Electrical and Electronic Equipment). Symbol for "Do not dispose of at the municipal collection points for used electrical equipment". Labelling as per IEC 60529 standard. Symbol for "splash protection".

Fig. 9: Symbols (Part 1 of 2)

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Introduction How to use these operating instructions

Symbols

1

Identification Labelling in compliance with the IEC 60601-1 standard. Symbol for "Potential equalisation".

Labelling of Category AP equipment as per the IEC 60601-1 standard. Explosion protection by avoiding sources of ignition when using flammable blends of anaesthetics which are mixed with air, oxygen or nitrous oxide. Labelling in compliance with the BGV A 8 Accident Prevention Regulations (previously VBG 125). Symbol for "Risk of pinching and crushing". Packaging label. Symbol for "Keep dry".

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

Packaging label. Symbol for "Top".

Labelling in compliance with the ISO 15223 -1 standard. Symbol for "Temperature range".

Labelling in compliance with the ISO 15223-1. Symbol for "Relative humidity".

Labelling in compliance with the ISO 15223-1. Symbol for "Air pressure".

Fig. 9: Symbols (Part 2 of 2)

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1

Introduction Disposal

1.3

Disposal

1.3.1

General Used products or parts thereof may be contaminated. To prevent potential infection, please clean and disinfect the product prior to return/disposal.

1.3.2

Packing The packing is made of materials compatible with the environment. MAQUET will dispose of the packing materials upon request.

1.3.3

Padding Padding can be disposed of as normal household waste.

1.3.4

Rechargeable batteries/ Batteries Rechargeable batteries/batteries can be turned in to your local disposal system.

1.3.5

MAQUET products MAQUET will take back used products or those which are no longer in service.

1.3.6

Used electrical equipment

1.3.6.1

Within the European Economic Community This product is governed by the 2002/96/EU Directive (Directive on Waste Electrical and Electronic Equipment). This product has not been registered for use in private households; disposal using municipal

1.3.6.2

Outside the European Economic Community When disposing of this product, ensure compliance with the applicable national regulations on the handling and disposal of used equipment.

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Please contact your MAQUET representative for more detailed information.

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

Introduction Overview

1.4

1

Overview

1

2

4

3

5

6

1a

15

7

15

14 13

1b

8

9

16

14

10

11

12

17 18

19 Fig. 10: Overview of OR table (1433.01XX) 1 Extension device (1433.62A1), optional: Screw tension device (1a) Gas strut assisted height adjustment (1b) 2 Extension shoe (1003.67C0), optional 3 Traction bar (1433.61AC), optional 4 Extension plate (1433.66AC), optional 5 Extension plate (1433.66BC), optional 6 Extension plate (1131.31BC), optional 7 NORMAL mounting point 8 Basic table top 9 Release button for traction bar

10 Connection for equipotential bonding 11 Connection for mains cable 12 Service mounting point 13 Override control panel 14 Connections for corded hand control / foot switch 15 Infrared receiver 16 REVERSE mounting point 17 IR remote control (1433.91A0), optional 18 Corded hand control (1433.90A0), optional 19 Foot switch (1009.81GX), optional

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1

Introduction Basic requirements

1.5

Basic requirements

1.5.1

Use in accordance with the intended purpose This product is an active Class I medical device according to the Medical Device Directive 93/42/EU, which will have to be entered in the medical device log. In accordance with the above-mentioned Directive, the only persons who may operate this product are those who have been instructed, by authorised personnel, in the use of the product. This product is to be used exclusively in human medicine. Patients may be placed on the device and brought into position only under the supervision of medical personnel.

1.5.2

Rooms used for medical purposes and in which the product is used shall comply with VDE Regulation 0100 Part 710 and/or the corresponding local codes. Accessories Accessories or combinations of accessories may be utilised only when and as indicated in these operating instructions. Use other accessories, combinations and parts subject to wear only if these are intended expressly for the application and will not adversely affect performance features or safety requirements.

Applicable standards The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted by the Medical Products Council (Medical Device Directive) as well as the applicable national codes and the Medical

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Products Act in Germany. This is certified by compliance with harmonised standards such as IEC 60601-1 and related standards and the respective special sections.