BETASTAR 1131.12 Operating Instructions V09.03 May 2011

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. V09.03 05-05-2011

1131.12 GA 1131.12 EN 09

Table of contents

1 1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.5.1 1.2.5.2 1.3 1.3.1 1.3.2 1.3.3 1.3.3.1 1.3.3.2 1.3.3.3 1.3.3.4 1.3.4 1.3.4.1 1.3.4.2 1.3.4.3 1.3.4.4 1.3.5 1.4 1.4.1 1.4.2 1.4.3 1.4.4 1.4.4.1 1.4.4.2 1.4.4.3

Introduction Foreword... 1 Environmental protection... 1 Packaging... 1 Rechargeable cells / Batteries... 1 Upholstery... 1 MAQUET products... 1 Disposal... 1 Within the European Economic Community... 1 Outside the European Economic Community... 1 How to use these operating instructions... 2 General... 2 Abbreviations... 2 Symbols... 3 Order number... 3 Cross-references... 3 Actions and responses... 3 Buttons and menus... 3 Definitions... 4 Design of safety notes... 4 Design for other notes... 4 Definition for 3-dimensional coordinate system... 5 Definition of slope and tilt... 5 Symbols used... 6 Operating table 1131.12... 8 Pictorial guide... 8 Use in accordance with the intended purpose... 9 Applicable standards... 9 Intended purposes... 10 Mobile operating table... 10 Control units... 10 Side rails... 10

2 2.1 2.1.1 2.2 2.3

Basic safety instructions Personal safety notes... 11 Mains operation... 13 Safety notes for the operating table... 14 Safety notes on the use of accessories... 15

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Table of contents

3 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.4.1 3.2.4.2 3.2.4.3 3.2.5 3.3 3.3.1 3.3.2 3.3.3 3.4 3.4.1 3.4.1.1 3.4.1.2 3.4.1.3 3.4.2 3.4.3 3.4.4 3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 3.6 3.7

Operation General... 16 Potential equalisation... 16 Mains operation / Charging the mobile operating table batteries... 17 Battery operation... 18 Acoustic signals... 18 Hand controls... 19 Connections for corded hand control and foot switch... 19 Corded hand control 1131.90A0 (optional)... 20 Override panel... 21 IR remote control 1131.91A0 (optional)... 22 Transmission power... 23 IR code... 23 Mobile charging station for IR remote control... 24 Foot switch (optional)... 25 Displace / immobilise the operating table... 26 Lock the operating table... 26 Move the operating table with directional stability... 27 Move the operating table laterally... 27 Mechanical adjustments... 28 Mounting / removing the head rest... 28 Mounting the head rest using the head rest adapter (1130.81A0)... 28 Mounting / removing the joint adapters (1131.82A0)... 30 Change out accessories at the joint adapter 1131.82A0... 32 Extension plate (1131.31B0)... 33 Seat plate extension (1131.55B0)... 34 X-ray top (1131.80A0) (optional)... 35 Column functions... 37 "Neurolock" function... 37 Move the table top into the horizontal position... 37 Raise / lower the table top... 39 Slope the table top... 39 Tilt the table top... 39 Raise / lower the the back plate... 39 Raise / lower the the leg plate... 39 Set the V-position... 40 Set the flex position... 40 Padding... 41 Explanation of instructions for use... 42

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Table of contents

4 4.1 4.1.1 4.1.1.1 4.1.1.2 4.1.2 4.1.2.1 4.1.2.2 4.2 4.2.1 4.2.2 4.2.2.1 4.2.2.2 4.2.3 4.2.3.1 4.2.3.2

Patient positioning Patient orientation... 43 Definition of patient orientation... 43 NORMAL patient orientation... 43 REVERSE patient orientation... 44 Set the patient orientation... 44 NORMAL patient orientation... 44 REVERSE patient orientation... 44 Patient positioning... 45 Patient positioning with a maximum patient weight of up to 454 kg... 45 Patient position with a maximum patient weight of 225 kg... 46 NORMAL patient orientation... 46 REVERSE patient orientation... 47 Patient position with a maximum patient weight of 135 kg... 48 NORMAL patient orientation... 48 REVERSE patient orientation... 49

5 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.2 5.2.1 5.2.2 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5

Cleaning and disinfection General... 50 Basic notes... 50 No mechanical cleaning and disinfection... 51 Stainless steel surfaces... 51 Padding... 51 Cleaning... 52 General... 52 Cleaning procedure... 52 Disinfection... 53 General... 53 Suitable disinfectants... 53 Disinfection procedure... 54 Cleaning / Wipe-disinfection of operating table... 54 Cleaning and manual disinfection of the swivel castors... 54

6 6.1 6.2 6.3

Inspections Visual and functional inspections... 55 Inspection and Maintenance... 56 Repair... 56

7 7.1

Malfunctions and troubleshooting General... 57

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Table of contents

8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 8.10.1 8.10.2 8.11 8.11.1 8.11.2

Technical specifications General specifications... 58 Ambient conditions... 58 Electrical specifications... 58 Dimensions... 59 Weights... 59 Slope... 60 Tilt... 60 Back plate... 61 Motor-powered joint... 61 NORMAL patient orientation... 62 Flex position... 62 Reflex position... 62 REVERSE patient orientation... 63 Flex position... 63 Reflex position... 63

9 9.1 9.1.1 9.1.2 9.1.3 9.2 9.2.1 9.2.2 9.2.3 9.3 9.3.1 9.4 9.4.1 9.4.2 9.4.3 9.4.4 9.4.5 9.5 9.5.1 9.5.2 9.5.3 9.6 9.6.1 9.6.2 9.6.3 9.7 9.7.1 9.7.2 9.7.3 9.8 9.9 9.10

Accessories and spare parts Accessories for head rest mounting point... 64 Head rests with pins (max. patient weight 454 kg)... 64 Head plates with pins (max. patient weight 225 kg)... 64 Head plates with central square tube (max. patient weight 135 kg)... 64 Accessories for leg plate mounting point... 66 Leg plates (max. patient weight 454 kg)... 66 Leg plates (max. patient weight 225 kg... 66 Leg plates and devices (max. patient weight 135 kg (300 lb))... 66 Accessories for mounting point at the joint (NORMAL / REVERSE)... 67 Back plates (max. patient weight 225 kg)... 67 Accessories for NORMAL and REVERSE mounting point... 68 Leg rests for NORMAL and REVERSE mounting point (max. patient weight 454 kg)... 68 Leg rests for NORMAL and REVERSE mounting point (max. patient weight 225 kg)... 69 Leg rests for NORMAL and REVERSE mounting point (max. patient weight 135 kg)... 70 Head rests for NORMAL and REVERSE mounting point (max. patient weight 454 kg)... 71 Head rests for NORMAL and REVERSE mounting point (max. patient weight 225 kg)... 72 Accessories for NORMAL mounting point... 73 Accessories for NORMAL mounting point (max. patient weight 454 kg)... 73 Accessories for NORMAL mounting point (max. patient weight 225 kg)... 73 Accessories for NORMAL mounting point (max. patient weight 135 kg)... 74 Accessories for REVERSE mounting point... 75 Accessories for REVERSE mounting point (max. patient weight 454 kg)... 75 Accessories for REVERSE mounting point (patient weight up to 225 kg)... 75 Accessories for REVERSE mounting point (patient weight up to 135 kg)... 76 Accessories for mounting on the side rails... 77 Accessories for side rail up to max. 454 kg (1000 lb)... 77 Accessories for side rail up to max. 270 kg... 77 Accessories for mounting on the side rails (max. patient weight 225 kg (500 lb))... 78 Control units... 79 Special-purpose accessories... 79 Spare parts... 80

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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

Environmental protection

1.2.1

Packaging

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.

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

Rechargeable cells / Batteries These can be turned in to your local disposal system for proper handling.

1.2.3

Upholstery Upholstery can be disposed of with normal household wastes.

1.2.4

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

1.2.5

Disposal

1.2.5.1

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

1.2.5.2

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 the correct and legal disposal.

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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1

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 familiarise you with the features of this MAQUET product. They are subdivided into several chapters.

1.3.2

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

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

Introduction How to use these operating instructions

1.3.3

Symbols

1.3.3.1

Order number

1

An "X" in the order number (e.g. 1122.33X4) is a placeholder for a number of variants. 1.3.3.2

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

1.3.3.3

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.

1.3.3.4

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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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 note describes the type result in most serious injury. of risk and how to avert it.

W ARNING!

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

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

Descriptor

Reference to

N OTE

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

1.3.4.3

1

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

1.3.4.4

3 Transverse plane

Definition of slope and tilt

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

3 Tilt 4 Slope

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1 1.3.5

Introduction How to use these operating instructions

Symbols used Symbols

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

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 in compliance with the EN 980 standard. Symbol for "Serial number".

Labelling as per IEC 60529 standard. Symbol for "splash protection".

Labelling in compliance with the EN 980 standard. Symbol for "Manufacturing date".

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

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

Packaging label. Symbol for "Keep dry".

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

Packaging label. Symbol for "Top".

Fig. 5: Symbols (Part 1 of 2)

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Introduction How to use these operating instructions

Symbols

1

Identification Transportation label. Symbol for "Temperature limitations".

Transportation label. Symbol for "Relative humidity".

Transportation label. Symbol for "Atmospheric pressure".

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". Fig. 5: Symbols (Part 2 of 2)

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1

Introduction Operating table 1131.12

1.4

Operating table 1131.12

1.4.1

Pictorial guide

1

2

3

4

5

6

9 10

7

11

8

10 12 15

14

15 13 16

14 15

19

18

17

Fig. 6: Pictorial guide - Operating table 1131.12 1 Head rest 1130.64XX (optional) 2 Head rest mounting point 3 Extension plate 1131.31XX (optional) 4 NORMAL mounting point (back plate mounting point) 5 Back plate 6 Seat plate 7 Motor-powered joint 8 REVERSE mounting point (leg plate mounting point) 9 Leg plate 1133.58XX (optional)

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10 Infrared receiver 11 Override panel 12 Connections for corded hand control and foot switch 13 Connection for mains cable 14 Locking pedal 15 Swivel castor 16 Swivel castor with directional locking device 17 Corded hand control 1131.90A0 (optional) 18 IR remote control 1131.91A0 (optional) 19 Foot switch (optional)

Introduction Operating table 1131.12

1.4.2

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.

1.4.3

1

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

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.

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1

Introduction Operating table 1131.12

1.4.4

Intended purposes

1.4.4.1

Mobile operating table The operating table (1131.12B0) serves to support and position patients for surgical procedures immediately before, during and after the surgical phase. The design of the table top makes the operating table suitable for every surgical discipline. The operating table can be used without restrictions for a maximum patient weight of 135 kg. The operating table can be used for patient weights of between 135 kg and 270 kg with some limitations. Under the application of fur-

1.4.4.2

Control units The control units are used to set the operating table.

1.4.4.3

ther limitations, patient weights of up to 454 kg are also permitted. The operating table (1131.12B0) may not be used: • if the patient weight exceeds 454 kg, • if the patient weight exceeds 135 kg, without taking the limitations into consideration, • with accessories which are not approved by MAQUET, • in rooms where MR tomographs are employed.

Side rails Side rails are used to mount approved accessories, in accordance with the manufacturer's instructions.

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Distinction is made as follows: • 1131.90A0, Corded hand control • 1131.91A0, IR remote control • 1009.81E0/E1/E2, Foot switch • Override panel (emergency use)

Basic safety instructions Personal safety notes

2

Basic safety instructions

2.1

Personal safety notes

2

D ANGER! Potentially fatal! Vital functions can be impaired through incorrect positioning. Position the patient correctly and maintain continuous observation.

W ARNING! Risk of injury! MAQUET products may be used only when properly lubricated and fully functional. Lubricate MAQUET products at regular intervals. Check to ensure that this MAQUET product is fully functional and in good working order prior to use.

W ARNING! Injury hazard! Before every use, put the operating table in the horizontal position and lock the castors by means of the locking pedal.

W ARNING! Risk of injury due to material failure! The total weight may not exceed 454 kg (1000 lb). In the event of greater loads being necessary, please consult MAQUET.

W ARNING! Injury hazard! Operating table may be tipping! The accessories mounted may not exceed the maximum permissible length.

W ARNING! Injury hazard resulting from the operating table tipping! Observe the prescribed orientation for the patient. Do not lay the patient's upper part of the body on the leg plates.

W ARNING! Injury hazard! If the patient is not secured during transportation, when adjusting the table top or when positioning the patient (particularly when the slope feature is used), then the patient could slip, uncontrolled, off the table top. Always secure the patient and maintain continuous observation.

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2

Basic safety instructions Personal safety notes

W ARNING! Injury hazard! When adjusting or moving the operating table or table top, the staff, the patient and the accessories are exposed to pinching and shearing hazards, particularly in the area around the joints at the head, back and leg plates. Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and the accessories do not collide with any nearby objects.

W ARNING! Health hazard! In the interests of hygiene the padding must be covered with sterile drapes.

W ARNING! Injury hazard! Electrical devices (e. g. cellphones, radios, magnetic resonance tomographs) can interfere with the functioning of the product when used near the product. Electrical devices which can interfere with the functioning of the product may not be used near the product. Please observe the information concerning electromagnetic compatibility (EMC) (radiation and resistance to interference) contained in the Technical Description. Adhere to those specifications when using electrical devices and respond properly in the event of effects on the device or the product.

W ARNING! Risk of burning! Using high-frequency devices, defibrillators and defibrillator monitors exposes the patient to burn hazard due to contact with metal components in the device or accessories and/or if resting on wet drapes or electrically conductive padding. Avoid any contact between the patient and metallic components; never use moist of wet surgical drapes. Be absolutely sure to comply with the manufacturers operating instructions!

W ARNING! Risk of injury! Improper positioning can be detrimental to patient health (causing bedsores, for instance). Always position the patient correctly and maintain continuous observation.

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Basic safety instructions Personal safety notes

2

W ARNING! Risk of injury due to material breakage or tipping of the operating table! The accessories attached to the operating table may not exceed the maximum reach (maximum distance to the accessory mounting point of the operating table). Accessories can be used without restrictions within the permitted load of the operating table with its share of the load imposed by a patient weighing 135 kg. For patients up to 454 kg, the operating table and all accessories used must be approved for the respective patient weight in addition to the permitted protrusion. Please observe these specifications for positioning the patient. 2.1.1

Mains operation

D ANGER! Risk of explosion! The operating table may not be used in hazardous locations (AP-M) during mains operation. An explosion could occur when using disinfectants or cleaning agents containing alcohol, or flammable anaesthetics which are blended with air, oxygen or nitrous oxide. When operating on the mains supply, never use disinfectants or cleaning agents containing alcohol, or flammable anaesthetics which are blended with air, oxygen or nitrous oxide!

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2 2.2

Basic safety instructions Safety notes for the operating table

Safety notes for the operating table

C AUTION! Property damage! Eliminate all potential hindrances and obstacles before moving the operating table and avoid collisions.

C AUTION! Property damage! When tilting or sloping the table top or when articulating the leg plate ensure that the table top does not collide with the column or the operating table base.

C AUTION! Property damage! Any objects left on the operating table base will damage the cladding as it moves. Do not put any objects on the operating table base.

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