ALPHAMAXX 1133.22 Operating Instructions Ver 05.05 May 2010

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. V05.01 10-05-2012

1133.22 GA 1133.22 EN 05

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 1.3.4.5 1.3.4.6 1.3.4.7 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... 2 Within the European Economic Community... 2 Outside the European Economic Community... 2 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 Definition of permissible overall load... 6 Definition of CENTRAL position... 6 Definition of hazardous location, Zone AP-M... 6 Symbols used... 7 Operating table 1133.22... 9 Pictorial guide... 9 Use in accordance with the intended purpose... 10 Applicable standards... 10 Intended purposes... 11 Mobile operating table... 11 Control units... 11 Side rails... 11

2 2.1 2.2 2.3

Basic safety instructions Personal safety notes... 12 Safety notes for the operating table... 16 Safety notes on the use of accessories... 16

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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 3.2.5 3.2.5.1 3.2.5.2 3.2.5.3 3.2.5.4 3.2.6 3.2.6.1 3.2.6.2 3.2.6.3 3.2.6.4 3.2.6.5 3.2.6.6 3.2.7 3.2.8 3.3 3.3.1 3.3.1.1 3.3.1.2 3.3.2 3.3.2.1 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 3.4.5 3.4.6 3.4.7 3.4.8 3.4.9 3.4.10 3.4.11 3.4.12 3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.4.1 3.5.4.2 3.5.4.3 3.5.5

Operation General... 18 Potential equalisation... 18 Mains operation / Charging the mobile operating table battery... 19 Battery operation... 20 Acoustic signals... 21 Hand controls... 22 General... 22 Override control panel... 22 Connections for corded hand control / foot switch / service interface... 24 Attaching the hand control to the side rail... 25 Corded hand control 1133.90R0... 26 General... 26 Connecting the corded hand control... 26 Control buttons and functions... 27 Switching on / off... 28 IR remote control 1133.91R0 (optional)... 29 General... 29 Control buttons and functions... 30 Transmission power... 31 IR code... 31 Mobile charging station for IR remote control... 32 Switching on / off... 33 IR wall control panel (optional)... 33 Foot switch (optional)... 34 Patient orientation... 35 Definition of patient orientation... 35 NORMAL patient orientation... 35 REVERSE patient orientation... 36 Setting the patient orientation... 36 Change the patient orientation... 36 Adjustment functions... 37 Move / immobilise the operating table... 37 General... 37 Displace the operating table using the (UNLOCK)... 38 Leave the operating table in a fixed position (LOCK)... 38 Moving the table top to the horizontal position... 39 Raising / lowering the table top... 40 Slope the table top... 40 Tilting the table top... 40 Shifting the table top longitudinally... 40 Raising / lowering the back plate... 41 Raising / lowering the the leg plate... 41 Adjusting the leg plate individually... 42 Setting the FLEX position... 43 Setting the BEACH CHAIR position... 43 "Neurolock" function... 44 Mechanical adjustments... 44 Accessory recognition feature... 44 Collision protection for leg plate adjustment... 45 Table width extension 1001.75A0/76A0... 46 Mounting / removing the head rest... 47 Mounting the head rest using the head rest adapter 1130.81A0... 47 Mounting / removing the joint adapters 1131.82A0... 49 Changing the accessories at the joint adapter 1131.82A0... 51 Extension plate 1131.31B0... 52

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Table of contents

3.5.6 3.5.6.1 3.5.6.2 3.5.7 3.5.7.1 3.5.7.2 3.6 3.7 3.7.1 3.7.2

Seat plate extension... 53 Seat plate extension 1131.55B0... 53 Seat plate extension 1133.55BC... 54 Leg plates... 55 Pair of leg plates 1133.53BC... 55 Leg plate 1133.58BC... 56 Padding... 57 Explanation of instructions for use... 58 CENTRAL position... 58 Height for operating table locking with an overall load of up to 135 kg... 58

4 4.1 4.1.1 4.1.2 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 4.3 4.3.1 4.3.2 4.3.2.1 4.3.2.2 4.3.3 4.3.3.1 4.3.3.2

Patient positioning Patient positioning at an overall load between 250 kg and 450 kg... 59 General... 59 Pictorial view of patient positions (overall load 250 kg - 450 kg)... 60 Patient positioning at an overall load between 135 kg and 250 kg... 61 General... 61 Operating table not immobilised (UNLOCK)... 61 NORMAL patient orientation / operating table not immobilised (UNLOCK)... 62 REVERSE patient orientation / operating table not immobilised (UNLOCK)... 63 Operating table immobilised (LOCK)... 64 NORMAL patient orientation / operating table immobilised (LOCK)... 64 REVERSE patient orientation / operating table immobilised (LOCK)... 65 Patient positioning with an overall load of up to 135 kg... 66 General... 66 Operating table not immobilised (UNLOCK)... 67 NORMAL patient orientation / operating table not immobilised (UNLOCK)... 68 REVERSE patient orientation / operating table not immobilised (UNLOCK)... 69 Operating table immobilised (LOCK)... 70 NORMAL patient orientation / operating table immobilised (LOCK)... 70 REVERSE patient orientation / operating table immobilised (LOCK)... 71

5 5.1 5.2 5.2.1 5.2.2 5.3 5.3.1 5.3.2 5.3.3 5.4 5.5 5.6

Cleaning and disinfection General... 72 Cleaning... 74 General... 74 Cleaning procedure... 75 Disinfection... 75 General... 75 Suitable disinfectants... 76 Disinfection procedure... 77 Stainless steel surfaces... 77 Padding... 77 Cleaning and manual disinfection of the swivel castors... 77

6 6.1 6.2 6.3

Inspections Visual and functional inspections... 78 Inspection and Maintenance... 79 Repair... 80

7 7.1

Malfunctions and troubleshooting General... 81

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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... 82 Ambient conditions... 82 Electrical specifications... 82 Weights... 82 Dimensions... 83 Slope... 84 Tilt... 84 Back plate... 85 Motor-powered joint... 85 NORMAL patient orientation... 86 FLEX position... 86 BEACH CHAIR position... 86 REVERSE patient orientation... 87 FLEX position... 87 BEACH CHAIR position... 87

9 9.1 9.2 9.2.1 9.2.2 9.2.3 9.3 9.3.1 9.3.2 9.3.3 9.4 9.4.1 9.4.2 9.4.3 9.5 9.6 9.7 9.8

Accessories and spare parts General... 88 Accessories for head-end mounting point... 88 Overall load of up to 450 kg (1000 Ib)... 88 Overall load of up to 250 kg (550 Ib)... 88 Overall load of up to 135 kg (300 Ib)... 90 Accessories for NORMAL mounting point (back plate mounting point)... 91 Overall load of up to 450 kg (1000 Ib)... 91 Maximum overall load of 250 kg (550 Ib)... 92 Overall load of up to a maximum of 135 kg (300 Ib)... 98 Accessories for REVERSE mounting plate (leg plate mounting point... 106 Maximum overall load of 450 kg (1000 lb)... 106 Maximum overall load of 250 kg (550 Ib)... 106 Overall load of up to a maximum of 135 kg (300 Ib)... 109 Accessories for side rails... 113 Positioning aids... 115 Hand controls... 115 Spare parts... 116

IV 1133.22 GA 1133.22 EN 05

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. Please contact your MAQUET representative for more detailed information.

1133.22 GA 1133.22 EN 05

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1

Introduction How to use these operating instructions

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

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.

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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Introduction How to use these operating instructions

1.3.4.5

Definition of permissible overall load Restrictions might result from the components or accessories for which other overall loads may be valid, or from special patient positions.

The "permissible overall load" results from adding up patient weight and side rail accessory weight. The "permissible overall load" is the load which can be put on the table top. 1.3.4.6

Definition of CENTRAL position The signal for reaching the CENTRAL position is when the table top adjustment stops during longitudinal shift of the table top.

A table top exceeding an overall load of 250 kg may only be operated if the longitudinal shift of the operating table is in the CENTRAL position. The operating table is in the CENTRAL position, when the centre table top bar (1) is above the column (2).

1

2

Fig. 5: CENTRAL position

1.3.4.7

Definition of hazardous location, Zone AP-M

N OTE The medical environment is designated as "Zone AP-M" (1).

1

Fig. 6: Hazardous location, Zone AP-M

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Introduction How to use these operating instructions

1.3.5

1

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. 7: Symbols (Part 1 of 2)

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Introduction How to use these operating instructions

Symbols

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. 7: Symbols (Part 2 of 2)

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Introduction Operating table 1133.22

1.4

Operating table 1133.22

1.4.1

Pictorial guide

1

20

2

21

3

4

22

5

6

7

23 14 15

8

9

1

10

13 14

12

11

15 16 17

19 18

25

26

24

Fig. 8: Pictorial guide - Operating table 1133.22 1 Head plate 1130.64XX (optional) 2 Head plate mounting point 3 Extension plate 1131.31XX (optional) 4 Mounting point: extension plate 5 Seat plate extension 1131.55XX (optional) 6 Mounting point: NORMAL (back plate mounting point) 7 Lower back plate 8 Seat plate 9 REVERSE mounting point (leg plate mounting point) 10 Leg plate 1133.58XX (optional) 11 Offset lever for abducting the leg plate 12 Release button for the leg plate 13 Bellows

14 Infrared receiver 15 Connections for corded hand control and foot switch 16 Override control panel 17 Service mounting point 18 Potential equalisation pin 19 Connection for mains cable 20 Release handle for head plate adjustment 21 Clamping bolt for head plate 22 Release lever for extension plate 23 Release lever for seat plate extension 24 Foot switch (optional) 25 IR remote control 1133.91R0 (optional) 26 Corded hand control 1133.90R0 (optional)

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1 1.4.2

Introduction Operating table 1133.22

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. Rooms used for medical purposes and in which the product is used shall comply with

1.4.3

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

10 1133.22 GA 1133.22 EN 05

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.

Introduction Operating table 1133.22

1.4.4

Intended purposes

1.4.4.1

Mobile operating table The operating table (1133.22XX) is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment. The design of the table top makes the operating table suitable for every surgical discipline. The operating table is designed for unlimited use with a maximum overall load of 135 kg. The operating table can be used unrestrictedly with a overall table top load between 135 kg and 450 kg. This overall load consists of the patient weight and the weight of the accessories which are mounted on the side rails.

1.4.4.2

The operating table (1133.22XX) may not be used: • if the overall load exceeds 450 kg, • if the overall load exceeds 135 kg, without taking restrictions into account, • with accessories which are not approved by MAQUET. • in rooms where MR tomographs are employed. The following distinctions are made: • mobile operating table (1133.22B4), with SFC pad, mounting point for 80°/-90° REVERSE slope and side rails in EUROPE format (10 x25 mm) • mobile operating table (1133.22B5), with SFC pad, mounting point for 80°/-90° REVERSE slope, side rails in EUROPE format (10 x25 mm) and autodrive • mobile operating table (1133.22F4), with SFC pad, mounting point for 80°/-90° REVERSE slope and side rails in US format (9.54 x28.6 mm) • mobile operating table (1133.22F5), with SFC pad, mounting point for 80°/-90° REVERSE slope, side rails in US format (9.54 x28.6 mm) and autodrive.

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

1.4.4.3

1

Distinction is made as follows: • 1133.90R0, corded hand control • 1133.91R0, IR remote control • 1009.81F0/F1/F2/F3, Foot switch • Override control panel (emergency use)

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

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2

Basic safety instructions Personal safety notes

2

Basic safety instructions

2.1

Personal safety notes

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

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

W ARNING! Risk of injury! Before every use, ensure that the mobile operating table is on a flat and level section of the floor and use the [LOCK] function to set the brakes.

W ARNING! Risk of injury due to material failure! The permissible overall load may not exceed 450 kg.

W ARNING! Risk of injury! If the patient's centre of gravity is not located in the middle of the table top then the table can tip over. Place the patient on the table top so that his/her navel is located above the column.

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Basic safety instructions Personal safety notes

W ARNING! Risk of injury due to material break or tipping over of the operating table! The accessories attached to the operating table must not exceed the maximum load (maximum distance to the accessory mounting point of the operating table). Accessory can be used without restriction within the permitted load of the operating table with its share of the load imposed by a patient weighing 135 kg. For an overall load up to 450 kg, the operating table and all accessories used must be approved for the respective patient weight in addition to the permitted load. Always consider maximum load, overall load, accessories used as well as possible restrictions for adjustment.

W ARNING! Risk of injury if the operating table tips during movement! With an overall load of up to 135 kg the mobile operating table may be set for maximum height of 940 mm, permitting it to be moved. (Function [UNLOCK]). The height marker (Page 58) is concealed when the table is within this permissible range.

W ARNING! Risk of injury due to the operating table tipping! In case of an overall load between 135 kg and 250 kg the swivel castors of the mobile operating table may only be extended in the lowest position of the table top (Function [UNLOCK]).

W ARNING! Risk of injury due to the operating table tipping! Never extend the swivel castors of the mobile operating table if the overall load exceeds 250 kg ([UNLOCK] function is prohibited).

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! Risk of injury due to the operating table tipping! If the patient is transferred to the operating table over the head end of the operating table, the operating table may tip. The patient may be transferred only from the side of the operating table.

W ARNING! Risk of injury due to the operating table tipping! If the operating table is not locked during patient transfer, the operating table may tip. The operating table must be locked on the floor before transferring the patient.

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2

Basic safety instructions Personal safety notes

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.

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! Injury hazard! When putting down the column, the operator's feet or objects standing or lying on the floor may get pinched or crushed. Before putting down the column, be sure to observe that there are neither the operator's feet nor any objects underneath the column.

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!

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