Instructions for Use
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Instructions for use 1133.22XX ALPHAMAXX mobile operating table
IFU 1133.22 EN 14 2019-10-02
Copyright notice All rights reserved. Any duplication, adaptation or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws. © Copyright MAQUET GmbH
Subject to technical modification! Due to further development of the product, the figures used and technical specifications given in these Instructions for Use may slightly differ from the current state of the product.
V14 12 02-10-2019
1133.22XX IFU 1133.22 EN 14
Contents
Contents 1
Introduction ...
9
1.1
How to use these operating instructions... 1.1.1 Abbreviations ... 1.1.2 Symbols and formatting ... 1.1.3 Definitions ... 1.1.3.1 Design of safety notes... 1.1.3.2 Structure of notes ... 1.1.3.3 Definition for 3-dimensional coordinate system... 1.1.3.4 Definition of inclination and tilt... 1.1.3.5 Definition of permitted overall load ... 1.1.3.6 Definition of protrusion ... 1.1.3.7 Definition of hazardous location, Zone AP-M ... 1.1.3.8 Definition Positioning- / Transporting ... 1.1.3.9 Definition of patient orientation...
9 9 10 10 10 11 12 12 13 13 13 13 14
1.2
Symbols used ...
15
1.3
Disposal ... 1.3.1 Old products... 1.3.2 Packaging ... 1.3.3 Batteries and rechargeable batteries ... 1.3.4 Pads and covers ... 1.3.5 Used electrical devices ...
18 18 18 18 18 18
1.4
Overview...
19
1.5
Basic requirements ... 1.5.1 Use in accordance with the intended purpose ... 1.5.2 Applicable standards... 1.5.3 Intended uses ... 1.5.3.1 Intended use mobile operating table ALPHAMAXX ... 1.5.3.2 Variants ... 1.5.4 Hand controls... 1.5.5 Corded control device (1133.90R0) ... 1.5.5.1 Intended use corded control device (1133.90R0) ... 1.5.5.2 Mounting points ... 1.5.5.3 Variants ... 1.5.6 Product features... 1.5.6.1 Significant features of ALPHAMAXX mobile operating table ... 1.5.6.2 Latex-free materials... 1.5.7 Reportable event...
20 20 20 20 20 21 21 21 21 21 21 22 22 22 22
2
Safety notes... 23
2.1
General safety notes ...
23
2.2
Safety notes for the OR table ...
25
2.3
Safety notes regarding service ...
27
2.4
Safety notes regarding the use of accessories...
28
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Contents
2.5
Safety notes regarding padding...
29
2.6
Safety notes EMC...
30
3
Initial operation ... 31
3.1
Storage ...
31
3.2
Ambient conditions ...
31
3.3
Power supply ...
31
3.4
IR code ... 3.4.1 Grouping of IR codes according to product groups ... 3.4.2 Determining / specifying the IR code ... 3.4.3 Clearing / blocking the IR reception ... 3.4.4 Setting the IR code on the IR remote control... 3.4.5 Setting the IR code on the mobile operating table ...
32 32 32 33 34 35
3.5
Venting the hydraulic oil ...
36
3.6
Setting the mains voltage ...
36
4
Hand controls and functions ... 39
4.1
General ...
39
4.2
Attaching the hand control to the side rail ...
40
4.3
Override control panel ... 40 4.3.1 Button occupation and functions of override control panel ... 41
4.4
Corded hand controls ... 4.4.1 Connecting corded hand controls ... 4.4.2 Corded hand control (1133.90R0) ... 4.4.2.1 Buttons and functions... 4.4.2.2 Switching the corded control device on... 4.4.3 Foot switch (1009.81F0/F1/F3)...
42 42 42 43 44 44
4.5
IR remote control (1133.91R0) ... 4.5.1 Control buttons and functions ... 4.5.2 Special feature of the IR remote control ... 4.5.2.1 IR code ... 4.5.2.2 Transmission power ... 4.5.2.3 Recharging the IR remote control ...
45 46 47 47 48 48
4.6
Adjustment functions ... 4.6.1 Set the patient orientation ... 4.6.2 Moving the table top to the horizontal position... 4.6.3 Raising / lowering the table top... 4.6.4 Incline the table top... 4.6.5 Tilting the table top laterally ... 4.6.6 Raising / lowering the back plate ... 4.6.7 Raising / lowering the leg plate ... 4.6.8 Shifting the table top longitudinally ... 4.6.9 Adjusting the leg plate individually ... 4.6.10 Setting the FLEX position ... 4.6.11 Setting the BEACH CHAIR position...
49 49 49 50 50 51 51 51 52 53 54 54
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Contents
4.6.12
Activating and deactivating the operating table lock ... 54
5
Operation and use... 56
5.1
General ...
56
5.2
OR table ... 5.2.1 Acoustic signals issued by the OR table... 5.2.2 Setting up equipotential bonding... 5.2.3 Charge batteries (mains operation) ... 5.2.4 Battery operation... 5.2.5 Connecting the service interface... 5.2.6 Displace / immobilise the OR table ... 5.2.6.1 Moving/locking the OR table with autodrive ... 5.2.6.2 Moving/locking the OR table without autodrive ...
56 56 57 59 60 60 61 62 63
5.3
Table tops and accessories ... 5.3.1 Accessory recognition... 5.3.2 Collision warning... 5.3.3 Mounting table width extensions (1001.75A0 / 76A0)... 5.3.4 Mounting/removing the head rest ... 5.3.4.1 Mounting and removing the head rest using the head rest adapter (1130.81A0) 5.3.4.2 Mounting / removing the joint adapters (1131.82A0) ... 5.3.4.3 Exchanging the accessories at the joint adapter (1131.82A0) ... 5.3.5 Mounting and removing the extension plate (1131.31BC)... 5.3.6 Mounting and removing the seat plate extension (1131.55BC ) ... 5.3.7 Mounting / removing the leg plates ... 5.3.7.1 Mounting and removing the pair of leg plates (1133.53BC) ... 5.3.7.2 Mounting and removing the leg plate (1133.58BC)... 5.3.8 Removing / mounting pads ...
64 64 64 65 66 66 68 70 71 72 73 73 74 75
5.4
Explanation of instructions for use... 5.4.1 Releasing the SENSOR DRIVE (1009.69A0/F0)... 5.4.2 CENTRAL position... 5.4.3 Height restrictions when moving the OR table with an overall load of up to 155 kg ...
76 76 77 77
6
Approved accessories and table top configuration ... 78
6.1
Table top configuration for an overall load up to 155 kg... 6.1.1 NORMAL patient orientation, OR table can be moved [UNLOCK] ... 6.1.2 REVERSE patient orientation, OR table can be moved [UNLOCK] ... 6.1.3 NORMAL patient orientation, OR table locked [LOCK]... 6.1.4 REVERSE patient orientation, OR table locked [LOCK]...
80 80 82 84 86
6.2
Table top configuration with an overall load of 155-250 kg ... 6.2.1 NORMAL patient orientation, OR table can be moved [UNLOCK] ... 6.2.2 REVERSE patient orientation, OR table can be moved [UNLOCK] ... 6.2.3 NORMAL patient orientation, OR table locked [LOCK]... 6.2.4 REVERSE patient orientation, OR table locked [LOCK]...
88 88 90 91 93
6.3
Table top configuration with an overall load of 250–450 kg ... 95 6.3.1 NORMAL patient orientation, OR table locked [LOCK]... 95
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Contents
6.4
Approved accessories ... 96 6.4.1 Side rail accessories ... 96 6.4.2 Hand controls... 96 6.4.3 Maximum overall load up to 155 kg ... 96 6.4.3.1 Accessories for NORMAL mounting point up to 155 kg ... 96 6.4.3.2 Accessories for the NORMAL mounting point up to 155 kg, OR table locked (LOCK) ... 97 6.4.3.3 Accessories for REVERSE mounting point up to 155 kg ... 98 6.4.3.4 Accessories for REVERSE mounting point up to 155 kg, OR table locked (LOCK) ... 99 6.4.4 Maximum overall load 155–250 kg ... 99 6.4.4.1 Accessories for NORMAL mounting point 155–250 kg ... 99 6.4.4.2 Accessories for REVERSE mounting point 155–250 kg ... 100 6.4.4.3 Accessories for the REVERSE mounting point up to 250 kg, OR table locked (LOCK) ... 101 6.4.5 Maximum overall load 250–454 kg ... 101 6.4.5.1 Accessories for NORMAL mounting point 250–450 kg ... 101 6.4.5.2 Accessories for REVERSE mounting point 250–454 kg ... 102
6.5
Projection... 102 6.5.1 Protrusion with a NORMAL patient orientation ... 102 6.5.2 Protrusion with a REVERSE patient orientation ... 104 6.5.3 Maximum height with moveable OR table (UNLOCK) ... 104
7
Cleaning and disinfection ... 105
7.1
General information ... 105 7.1.1 No mechanical preparation ... 106 7.1.2 Padding... 107
7.2
Cleaning agents and disinfectants... 108 7.2.1 Suitable cleaning agents... 108 7.2.2 Suitable disinfectants ... 108 7.2.3 Non-usable products / substances... 108
7.3
Prepare the OR table for cleaning ... 109
7.4
Preparation ... 109 7.4.1 Pre-cleaning... 109 7.4.2 Disinfection ... 109 7.4.3 Drying... 110 7.4.4 Inspections... 110
7.5
Clean and disinfect the swivel castors... 110
8
Maintenance ... 111
8.1
Visual and functional inspections ... 111
8.2
Malfunctions and troubleshooting ... 113
8.3
Inspection and Maintenance... 114
8.4
Maintenance of corded hand controls ... 114
8.5
Repair ... 115
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Contents
8.6
Type plate position ... 115
8.7
Exchanging the fuse ... 116
9
Technical specifications... 118
9.1
General specifications ... 118
9.2
Ambient conditions ... 118
9.3
Electrical specifications ... 118
9.4
Noise level ... 118
9.5
Weight ... 119
9.6
Dimensions ... 119
9.7
Inclination ... 120
9.8
Tilt ... 120
9.9
Longitudinal shift... 121
9.10 Back plate ... 121 9.11 Motorised joint module ... 122 9.12 OR table positions ... 122 9.12.1 FLEX position... 122 9.12.2 BEACH CHAIR position ... 123 9.13 Electromagnetic compatibility (EMC)... 124 9.13.1 Electromagnetic emissions ... 124 9.13.2 Resistance to electromagnetic interference... 125 9.13.3 Cable lengths ... 126
Index... 127
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Contents
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1133.22XX IFU 1133.22 EN 14
Introduction How to use these operating instructions
1
Introduction
1.1
How to use these operating instructions
1
These operating instructions are provided to familiarise you with the features of this product. The operating instructions are divided into separate chapters. Please note: • Read these operating instructions through 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 the vicinity of the product.
1.1.1
Abbreviations EC EMC EN EEC HD HF IEC INT IP IPS IR ISO LED MDD OR table PUR RF SELV SFC SN UL UPS
1133.22XX IFU 1133.22 EN 14
European Community Electromagnetic compatibility European standard European Economic Community Harmonization document High Frequency International Electrotechnical Commission Intermittent International Protection (type of protection against ingress of solid bodies and liquids) Internal Power Source Infrared International Organization for Standardization Light-Emitting Diode Medical Devices Act Operating table Polyurethane integral foam Radio frequency Safety Extra Low Voltage Soft Foam Core (special foam core) Serial no. Underwriters Laboratories Inc. Uninterrupted Power Supply
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1
Introduction How to use these operating instructions
1.1.2
Symbols and formatting Symbol
Meaning
1. 2.
Instructions to follow / list with numbered steps Result of an action
●
Numbered steps / List entry / precondition Reference to other pages within this document
[...]
Key / Module / Mode
bold
Menu / on-screen button
[italics]
Field to be filled in
1122.33XX
Order number with different variants (XX)
Tab. 1:
Symbols and formatting
1.1.3
Definitions
1.1.3.1
Design of safety notes Pictogram
Tab. 2:
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Descriptor
Text
DANGER!
Identifies an immediate danger to people, which may result in death or serious injuries.
WARNING!
Identifies a potential danger to people or property, which may result in damage to health or serious property damages.
CAUTION!
Identifies a potential danger to property, which may result in property damages.
Design of safety notes
1133.22XX IFU 1133.22 EN 14
Introduction How to use these operating instructions
1.1.3.2
1
Structure of notes Pictogram
Tab. 3:
1133.22XX IFU 1133.22 EN 14
Descriptor
Explanation
NOTE
Supplementary assistance or further useful information which does not indicate a risk of injury to persons or a risk of property damage are described in the text of the note.
ENVIRONMENT
Information regarding proper disposal.
Structure of notes
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1
Introduction How to use these operating instructions
1.1.3.3
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. 1:
1.1.3.4
1
Frontal plane (horizontal plane)
2
Sagittal plane
3
Transverse plane
Definition of inclination and tilt
Fig. 2:
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Definition of terms for the 3-dimensional coordinate system
Definition of inclination and tilt
1
Reverse Trendelenburg
3
Lateral tilt
2
Trendelenburg (head down)
4
Inclination
1133.22XX IFU 1133.22 EN 14
Introduction How to use these operating instructions
1.1.3.5
1
Definition of permitted overall load The maximum permitted overall load is derived by adding the patient weight, side rail accessory weights and weight of positioning aids. The maximum permitted overall load is the maximum load that may be placed on the table top. Restrictions may result from the components, table top and transporter, special patient positioning devices or the accessories used for which other overall loads or weight loads apply.
1.1.3.6
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. The maximum protrusion of a table top may not be exceeded.
1.1.3.7
Definition of hazardous location, Zone AP-M The term "AP-M zone" 1 is used to refer to the medical environment.
1
Fig. 3:
1.1.3.8
Area with a risk of explosions, AP-M zone
Definition Positioning- / Transporting When moving, a distinction is made between moving the mobile operating table with a patient and without a patient. Positioning Positioning refers to the process of moving the mobile operating table with a patient and within the operating room. Transporting Transporting refers to the process of moving the mobile operating table without a patient in the operating room.
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1
Introduction How to use these operating instructions
1.1.3.9
Definition of patient orientation
WARN IN G ! Risk of injury! If the selected patient orientation is not correct, this may result in OR table adjustments in an undesired direction. Check the correct patient orientation before every adjustment. The patient orientation is indicated by the NORMAL or REVERSE LEDs on the control device. The patient orientation is based on the position of the patient on the table compared to the OR table base. NORMAL patient orientation The upper part of the patient's body is located above the longer section of the OR table base 1.
1
Fig. 4:
NORMAL patient orientation
REVERSE patient orientation The legs are located above the longer section of the OR table base 1 .
1
Fig. 5:
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REVERSE patient orientation
1133.22XX IFU 1133.22 EN 14
Introduction Symbols used
1.2
1
Symbols used Symbols are attached to products, type plates and packaging. Symbols
Labelling Labelling of products developed and marketed in accordance with relevant European legal provisions.
UL classification mark from Underwriters Laboratories as proof that the product has been assessed by Underwriters Laboratories for specific properties in order to exclude risks and to confirm the usability under certain circumstances. This labelling signifies compliance with the requirements both for the USA and for Canada. Labelling in accordance with the standard ISO 15223-1. Symbol for "Catalogue number / product number".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Serial number".
Symbol for the labelling of medical devices
Labelling in accordance with the standard ISO 15223-1. Symbol for "Name and address of the manufacturer". The date of manufacturing can be combined with this symbol. Labelling in accordance with the ISO 15223-1 standard. Symbol für "Consult instructions for use".
Marking according to the standard ISO 15223-1. Symbol for "Pay attention to the supplied documents".
Labelling in accordance with the IEC 60601-1 standard. Symbol for "Follow Instructions for use".
Tab. 4:
1133.22XX IFU 1133.22 EN 14
Symbols
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1
Introduction Symbols used
Symbols
Labelling Labelling of devices with an applied part of Type B in accordance with the IEC 60601-1 standard. Level of protection against electric shock. Labelling in accordance with the IEC 60601-1 standard. Symbol for "Class II Equipment"
Labelling in accordance with the 2012/19/EU directive (on used electrical equipment and electronics). Symbol for "Do not dispose of product via the municipal collection points for used electrical equipment". Labelling in compliance with the IEC 60529 standard. Symbol for "Splash protection".
Labelling in compliance with the IEC 60601-1 standard. Symbol for "Equipotentiality".
Labelling of devices in the AP class in accordance with the IEC 60601-1 standard. Explosion protection ensured by the avoidance of ignition sources when using flammable blends of anaesthetics that are mixed with air, oxygen or nitrous oxide. Marking in compliance with the standard ISO 7010 Symbol for “warning concerning injury to hands e.g. Hazard of crushing, shearing Labelling in accordance with the ISO 15223-1 standard. Labelling of packaging materials. Symbol for "Keep dry". Labelling in accordance with the ISO 15223-1 standard. Symbol for "Fragile! Handle with care".
Labelling in accordance with the ISO 7000 standard. Symbol for "Top".
Tab. 4:
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Symbols
1133.22XX IFU 1133.22 EN 14
Introduction Symbols used
Symbols
1
Labelling Labelling in accordance with the ISO 15223-1 standard. Symbol for "Temperature limit".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Humidity limitation".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Atmospheric pressure limitation".
Tab. 4:
1133.22XX IFU 1133.22 EN 14
Symbols
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1
Introduction Disposal
1.3
Disposal
1.3.1
Old products Getinge will take back used products or those which are no longer in service. For further information, please contact your personal Getinge representative. Used products or parts thereof may be contaminated. In order to prevent a potential infection, the product must be cleaned and disinfected prior to its return/disposal. The national regulations and disposal regulations must be observed for all disposal measures.
1.3.2
Packaging The packing materials are made of materials compatible with the environment. The packing material may be disposed of by Getinge on request.
1.3.3
Batteries and rechargeable batteries Rechargeable batteries/batteries can be submitted to your regional disposal system.
ENVI RO NMEN T Defective rechargeable batteries must be recycled in accordance with guideline 2006/66/EC. Defective rechargeable batteries may not be opened, disposed of in household waste, burned or thrown in water. Defective rechargeable batteries should be returned to local collection points.
1.3.4
Pads and covers Pads and covers may be disposed of via the household waste.
1.3.5
Used electrical devices Within the European Economic Community This product is within the scope of the validity of guideline 2012/19/EU (waste electrical and electronic equipment). This product is not registered for use in private households, it may also not be disposed of disposal via municipal collection points for waste electrical and electronic equipment. For further information on legally compliant disposal, please contact the assigned Getinge representative. Outside the European Economic Community When disposing of this product, ensure compliance with the applicable national regulations on the handling and disposal of used electrical equipment.
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Introduction
1
Overview
1.4
Overview 1
2
20
21
3
4
5
6
7
8
10
9
13 22
23
14
14
12
11
15
15
16 17
18 19
25
26
24
Fig. 6:
Overview of OR table (1133.22B4/B5/F4/F5)
1
Head rest (1130.64A0/C0/D0/F0/G0), optional
14 Infrared receiver
2
Head rest mounting point
3
Extension plate (1131.31BC), optional
15 Connections for the corded control devices and foot switch
4
Extension plate mounting point
16 Override control panel
5
Seat plate extension (1131.55BC), optional
17 Service mounting point
6
NORMAL mounting point (back plate mounting point)
18 Equipotential bonding pin
7
Lower back plate
20 Tommy screw for head rest adjustment
8
Seat plate
21 Head rest fixation screw
9
Mounting point REVERSE (Leg plate mounting point)
22 Release lever extension plate
19 Socket for mains cable
23 Release lever seat plate extension
10 Leg plate (1133.53BC/FC), optional
24 Foot switch, optional
11 Offset lever for abducting leg plates
25 IR remote control (1133.91R0), optional
12 Release button leg plate
26 Corded control device (1133.90R0), optional
13 Bellows
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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 a medical device. The product may only be operated by persons who have been instructed in the use of the product by an authorised person. The product is designed solely for the purpose of human medicine. The patient may only be placed and positioned under medical supervision. Rooms used for medical purposes in which the product is operated must comply with HD 60364-7-710 or equivalent national regulations. The EMC characteristics of this product allow its use in industrial and hospital environments (CISPR 11, Class A). This product may not provide adequate protection against radio services when used in a residential environment (which typically requires Class B according to CISPR 11). If necessary, the user must take corrective measures such as conversion or reorientation of the product. Accessories Accessories or combinations of accessories may only be used as and when indicated in these instructions for use. Other accessories, combinations of accessories or consumables may only be used if they are designed specifically for the use in question and will not adversely affect either performance features or safety requirements.
1.5.2
Applicable standards The product meets the basic safety and performance requirements in accordance with the local applicable legal specifications for medical devices.
1.5.3
Intended uses
1.5.3.1
Intended use mobile operating table ALPHAMAXX The ALPHAMAXX (1133.22XX) mobile operating table is designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment. Thanks to the design of the table top, the OR table is suitable for all surgical disciplines. The table top is suitable for imaging procedures that use x-rays. The OR table may be used without restrictions on the patient positions and adjustment functions with an overall load of up to 155 kg. With an overall load between 155-450 kg, the OR table may be used with restrictions. The product may only be operated by medically trained staff within the OR environment. Any use other than those described above is deemed not to be in compliance with the intended purpose. The OR table may not be used for the following purposes, or under the following conditions: • With a maximum overall load exceeding 450 kg • With accessories which are not approved by MAQUET • In rooms where magnetic resonance tomographs are employed
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