Instructions for Use
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Instructions for use 7200.01XX MEERA mobile operating table
IFU 7200.01 EN 10 2019-10-10
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.
V10 07 10-10-2019
7200.01XX IFU 7200.01 EN 10
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 hazardous location, Zone AP-M ... 1.1.3.6 Definition of permitted overall load ... 1.1.3.7 Definition of protrusion ... 1.1.3.8 Definition Positioning- / Transporting ... 1.1.3.9 Definition of usage-related restrictions ... 1.1.3.10 Definition of patient orientation... 1.1.3.11 Definition of CENTRAL position ... 1.1.3.12 Definition of applied part...
9 9 10 11 11 11 12 12 13 13 13 13 14 14 15 16
1.2
Symbols used ...
17
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 ...
20 20 20 20 20 20
1.4
Overview...
21
1.5
Basic requirements ... 1.5.1 Use in accordance with the intended purpose ... 1.5.2 Applicable standards... 1.5.3 MEERA OR table (7200.01XX)... 1.5.3.1 Intended purpose MEERA operating table (7200.01XX)... 1.5.3.2 Variants ... 1.5.4 Corded control device (7200.90A0) ... 1.5.4.1 Intended purpose corded control device (7200.90A0) ... 1.5.4.2 Mounting points ... 1.5.4.3 Variants ... 1.5.5 Control devices, optional... 1.5.6 Product features... 1.5.6.1 Essential performance... 1.5.6.2 Latex-free materials... 1.5.7 Reportable event...
22 22 22 22 22 23 23 23 23 23 23 24 24 24 24
2
Safety notes... 25
2.1
General safety notes ...
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Contents
2.2
Safety notes for the OR table ...
27
2.3
Safety notes regarding the use of accessories...
29
2.4
Safety notes regarding service ...
30
2.5
Safety notes regarding padding...
31
2.6
Safety notes EMC...
32
3
Initial operation ... 33
3.1
Storage ...
33
3.2
Ambient conditions ...
33
3.3
Power supply ...
33
3.4
Connecting the service interface ...
34
3.5
IR code ... 3.5.1 Grouping of IR codes according to product groups ... 3.5.2 Determining / specifying the IR code ... 3.5.3 Carrying out a functional test ...
36 36 37 37
3.6
Venting the hydraulic oil ...
37
4
Hand controls and functions ... 38
4.1
General ...
38
4.2
Acoustic signals of the IR remote control ...
38
4.3
Mounting the control device to the side rail ...
39
4.4
Override control panel ... 39 4.4.1 Control buttons and functions ... 40
4.5
Corded hand controls ... 4.5.1 Connecting/removing corded control devices ... 4.5.2 Corded hand control (7200.90A0)... 4.5.2.1 Control buttons and functions... 4.5.2.2 Switching the corded hand control on and off ... 4.5.3 Foot switch (1009.81J0/J1/J2) ...
41 41 42 42 43 44
4.6
IR remote control (7200.91A0) ... 4.6.1 Special features of the IR remote control (7200.91A0)... 4.6.1.1 IR code ... 4.6.1.2 Transmission power ... 4.6.2 Recharging the IR remote control ...
44 45 45 45 45
4.7
Adjustment functions ... 4.7.1 Adjusting the height of the OR table ... 4.7.2 Adjusting accessories using the motor ... 4.7.3 Balancing the leg plate... 4.7.4 Inclining the table top ... 4.7.5 Tilting the table top laterally ... 4.7.6 Moving the table top longitudinally... 4.7.7 Moving the table top to the horizontal position... 4.7.8 Deactivating the lock function temporarily ...
46 46 47 48 49 50 50 51 53
4.8
Operating menu ...
54
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Contents
4.8.1 4.8.2 4.8.3 4.8.4 4.8.5
4.8.6 4.8.7
4.8.8
4.8.9
4.8.10
General ... Display design... Symbols for status bar ... Symbols for navigation bar ... Standard patient positions ... 4.8.5.1 FLEX / REFLEX position ... 4.8.5.2 BEACH CHAIR / BACK HORIZONTAL position ... 4.8.5.3 NORMAL / REVERSE patient orientation ... Menu item [System information] ... Menu [Patient positions]... 4.8.7.1 Select patient position ... 4.8.7.2 Moving into patient position... 4.8.7.3 Saving the patient position ... 4.8.7.4 Editing names for patient position ... Menu [Settings] ... 4.8.8.1 Select the menu item in the [Settings] menu... 4.8.8.2 Activating / deactivating the operating table lock ... 4.8.8.3 Activating / deactivating the table top lock ... 4.8.8.4 Switching the illumination on and off ... 4.8.8.5 Switching the signal tone of the OR table on and off ... 4.8.8.6 Displaying the maintenance date ... 4.8.8.7 Displaying the adjustment angle ... 4.8.8.8 Switching the selective button illumination on and off ... [Service] menu ... 4.8.9.1 Select the menu items in the [Service] menu ... 4.8.9.2 Setting the IR code... 4.8.9.3 Set the language ... 4.8.9.4 Display system information ... 4.8.9.5 Set the display contrast ... 4.8.9.6 Reset to the factory settings... Menu [Fast memory] ... 4.8.10.1 Selecting the function in the [Fast memory] menu ... 4.8.10.2 Moving into patient position... 4.8.10.3 Saving the patient position ...
54 54 55 56 57 57 58 58 59 59 60 61 61 62 63 63 63 64 65 65 66 66 67 67 67 68 68 69 69 69 70 70 71 71
5
Operation and use... 72
5.1
General ...
72
5.2
OR table ... 5.2.1 Acoustic signals issued by the OR table... 5.2.2 Setting up equipotential bonding... 5.2.3 Status indicators mains connection / battery charge state... 5.2.3.1 Overview of status display for mains connection ... 5.2.3.2 Overview of status display for battery charge state... 5.2.4 Battery operation... 5.2.5 Deep discharge protection ...
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Contents
5.2.5.1 Automatic deep discharge... 5.2.5.2 Activate deep discharge protection manually... Charge batteries (mains operation) ... Displacing / locking the OR table ... 5.2.7.1 Status display [LOCK] / [UNLOCK] ... 5.2.7.2 Moving the OR table without autodrive [UNLOCK] ... 5.2.7.3 Moving the OR table using autodrive [UNLOCK] ... 5.2.7.4 Locking the OR table [LOCK] ...
76 76 77 79 80 80 81 82
5.3
Table tops and accessories ... 5.3.1 Mounting the table width extensions (1001.75A0 / 76A0)... 5.3.2 Mounting / removing the head rest ... 5.3.2.1 Mounting and removing the head rest using the head rest adapter (1130.81A0) 5.3.3 Extension plate (1131.31BC) ... 5.3.4 Mounting and removing the seat plate extension (1131.55BC ) ... 5.3.5 Mounting / removing the leg plates ... 5.3.5.1 Mounting / removing the pair of leg plates (1133.53BC) ... 5.3.5.2 Mounting / removing the leg plate (1133.58BC)... 5.3.6 Attaching the X-ray top (1131.80A0), optional ... 5.3.6.1 Mounting / removing the X-ray top ... 5.3.7 Removing / mounting pads ...
83 83 84 84 86 86 87 88 89 89 91 92
5.4
Explanation of instructions for use... 93 5.4.1 CENTRAL position... 93 5.4.2 Maximum height when moving the OR table with an overall load of up to 250 kg... 93
6
Approved accessories and table top configuration ... 94
6.1
Table top configuration for an overall load up to 155 kg... 96 6.1.1 NORMAL patient orientation / OR table can be moved (UNLOCK)... 96 6.1.2 REVERSE patient orientation/ OR table can be moved (UNLOCK) ... 98 6.1.3 NORMAL patient orientation/OR table locked (LOCK) ... 100 6.1.4 REVERSE patient orientation/OR table locked (LOCK) ... 102
6.2
Table top configuration with an overall load of 155-250 kg ... 104 6.2.1 NORMAL patient orientation / OR table can be moved (UNLOCK)... 104 6.2.2 REVERSE patient orientation / OR table can be moved (UNLOCK) ... 106 6.2.3 NORMAL patient orientation/OR table locked (LOCK) ... 107 6.2.4 REVERSE patient orientation/OR table locked (LOCK) ... 109
6.3
Table top configuration with an overall load of 250–450 kg ... 111 6.3.1 Usage-related restrictions for 250-454 kg... 111 6.3.2 NORMAL patient orientation/OR table locked (LOCK) ... 112
6.4
Approved accessories ... 113 6.4.1 Side rail accessories ... 113 6.4.2 Hand controls... 113 6.4.3 Maximum overall load up to 155 kg ... 113 6.4.3.1 Accessories for NORMAL mounting point up to 155 kg ... 113 6.4.3.2 Accessories for the NORMAL mounting point up to 155 kg, OR table locked (LOCK) ... 114
5.2.6 5.2.7
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Contents
6.4.3.3 6.4.3.4 6.4.4
6.4.5
Accessories for REVERSE mounting point up to 155 kg ... 115 Accessories for the REVERSE mounting point up to 155 kg, OR table locked (LOCK) ... 116 Maximum overall load 155–250 kg ... 116 6.4.4.1 Accessories for NORMAL interface from 155–250 kg... 116 6.4.4.2 Accessories for REVERSE mounting point 155–250 kg ... 117 6.4.4.3 Accessories for the REVERSE mounting point up to 250 kg, OR table locked (LOCK) ... 118 Maximum overall load 250–454 kg ... 119 6.4.5.1 Accessories for NORMAL interface from 250-454 kg ... 119 6.4.5.2 Accessories for REVERSE mounting point 250–454 kg ... 119
6.5
Projection... 119 6.5.1 Protrusion with a NORMAL patient orientation ... 119 6.5.2 Protrusion with a REVERSE patient orientation ... 120 6.5.3 Maximum height with moveable OR table (UNLOCK) ... 121
7
Display notes... 122
7.1
Structure of display notes ... 122
7.2
Notes on use ... 122
7.3
Warning notes / Status messages ... 124
8
Cleaning and disinfection ... 126
8.1
General information ... 126 8.1.1 No mechanical preparation ... 127 8.1.2 Padding... 128
8.2
Cleaning agents and disinfectants... 129 8.2.1 Suitable cleaning agents... 129 8.2.2 Suitable disinfectants ... 129 8.2.3 Non-usable products / substances... 129
8.3
Prepare the OR table for cleaning ... 130
8.4
Preparation ... 130 8.4.1 Pre-cleaning... 130 8.4.2 Disinfection ... 130 8.4.3 Drying... 130 8.4.4 Inspections... 130
9
Maintenance ... 131
9.1
Visual and functional inspections ... 131
9.2
Malfunctions and troubleshooting ... 134 9.2.1 OR table... 134 9.2.2 IR remote control ... 136
9.3
Inspection and Maintenance... 137
9.4
Maintenance of corded hand controls ... 137
9.5
Repair ... 137
9.6
Type plate position ... 138
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Contents
9.7
Replacing fuse/setting the mains voltage ... 138
10
Technical specifications... 140
10.1 General specifications ... 140 10.2 Ambient conditions ... 140 10.3 Surface temperature of application set ... 140 10.4 Noise level ... 140 10.5 Electrical specifications ... 140 10.6 Weight ... 141 10.7 Dimensions ... 141 10.8 Adjustment ranges... 142 10.8.1 Longitudinal shift ... 142 10.8.2 Inclination... 142 10.8.3 Tilt ... 143 10.8.4 Back plate ... 143 10.8.5 Leg plate ... 144 10.9 Table top positions ... 145 10.9.1 FLEX position... 145 10.9.2 REFLEX position... 146 10.9.3 BEACH CHAIR position ... 147 10.10Electromagnetic compatibility (EMC)... 148 10.10.1 Cable lengths ... 148 10.10.2 Electromagnetic emissions ... 148 10.10.3 Resistance to electromagnetic interference... 148
Index... 150
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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
7200.01XX IFU 7200.01 EN 10
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:
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Symbols and formatting
7200.01XX IFU 7200.01 EN 10
Introduction How to use these operating instructions
1.1.3
Definitions
1.1.3.1
Design of safety notes Pictogram
Tab. 2:
1.1.3.2
1
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
Structure of notes Pictogram
Tab. 3:
7200.01XX IFU 7200.01 EN 10
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
7200.01XX IFU 7200.01 EN 10
Introduction How to use these operating instructions
1.1.3.5
1
Definition of hazardous location, Zone AP-M The term "AP-M zone" 1 is used to refer to the medical environment.
1
Fig. 3:
1.1.3.6
Area with a risk of explosions, AP-M zone
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 special patient positioning devices or the accessories used for which other weight loads may apply.
1.1.3.7
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.
1.1.3.8
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 usage-related restrictions As of certain overall load thresholds and when moving the mobile operating table, one or more of the following usage-related restrictions apply: • Use of accessories • Protrusion • Adjustment functions • Patient orientation • Moving the operating table The specific usage-related restrictions are listed in the chapter on tabletop configurations [8 Page 94] in the appropriate sub-chapters.
1.1.3.10
Definition of patient orientation
WARN IN G ! Risk of injury! Incorrectly adjusted patient orientation may cause adjustment of the OR 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 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:
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NORMAL patient orientation
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Introduction How to use these operating instructions
1
REVERSE patient orientation The legs are located above the longer section of the OR table base 1 .
1
Fig. 5:
1.1.3.11
REVERSE patient orientation
Definition of CENTRAL position 1
2
Fig. 6:
CENTRAL position
With an overall load of 250 kg, the OR table may only be used if the OR table is in the CENTRAL position: The longitudinal shift of the OR table is lifted and the centre table top bar 1 is above the column 2 . The table top stops at the CENTRAL position during a longitudinal shift. depending on the OR table used, the longitudinal shift is then automatically continued or must be continued by pressing the button once again.
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1
Introduction How to use these operating instructions
1.1.3.12
Definition of applied part
Fig. 7:
Applied part, OR table: Table top
The applied part of the OR table is the table top.
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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:
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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
7200.01XX IFU 7200.01 EN 10
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:
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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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