Instructions for Use
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Instructions for use 1118.06B0/F0/F1/K0 Mobile operating table ALPHACLASSIC PRO
IFU 1118.06 EN 10 2020-06-05
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 (Suzhou) Co., Ltd
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 03 05-06-2020
1118.06B0/F0/F1/K0 IFU 1118.06 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 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 usage-related restrictions ... 1.1.3.10 Definition of patient orientation... 1.1.3.11 CENTRAL position ...
9 9 9 10 10 10 11 11 12 12 12 12 12 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 ...
17 17 17 17 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 ALPHACLASSIC PRO (1118.06XX) ... 1.5.3.1 Intended use... 1.5.3.2 Variants ... 1.5.3.3 Product features ... 1.5.3.4 Reportable event ... 1.5.4 Hand controls... 1.5.5 Corded control device (1118.90J0)... 1.5.5.1 Corded control device (1118.90J0) ... 1.5.5.2 Mounting points ... 1.5.5.3 Variants ... 1.5.6 Side rails ...
20 20 20 21 21 21 21 22 22 22 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
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Contents
2.4
Safety notes regarding the use of accessories...
28
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 Clearing / blocking the IR reception ... 3.4.3 Setting the IR code on the mobile operating table ... 3.4.4 Setting the IR code on the IR remote control... 3.4.5 Activating the [IR code] menu ... 3.4.6 Setting the value of the IR code... 3.4.7 Terminating the [IR code] menu... 3.4.8 Checking adjustment functions ...
31 31 32 33 34 36 36 37 38
3.5
Venting the hydraulic oil ...
39
4
Hand controls and functions ... 40
4.1
General ...
40
4.2
Mounting the control device to the side rail ...
41
4.3
Override control panel ... 41 4.3.1 Button occupation and functions... 42
4.4
Corded hand controls ... 4.4.1 Acoustic signals at the corded hand control (1118.90J0) ... 4.4.2 Connecting/disconnecting the control device... 4.4.3 Corded control device ... 4.4.3.1 Control buttons and functions... 4.4.3.2 Switching the corded control device on/off... 4.4.4 Foot switch (1009.81E0/E1), optional ...
43 43 43 44 45 46 46
4.5
IR remote control 1118.91J0 (optional) ... 4.5.1 Button occupation and functions... 4.5.2 Switching on the IR remote control ... 4.5.3 Transmission power... 4.5.4 Charging unit (1009.70A0) / Charging station (1009.71A0/B0) ... 4.5.5 Mobile charging unit (1009.70A0) ... 4.5.6 Stationary charging unit (1009.71A0/B0) ... 4.5.7 Recharging the IR remote control ...
47 48 48 49 49 49 51 51
4.6
Adjustment functions ... 4.6.1 Set the patient orientation ... 4.6.2 Aligning the table top in the horizontal position... 4.6.3 Lowering/raising the table top ... 4.6.4 Inclining the table top ... 4.6.5 Tilting the table top laterally ...
52 52 52 54 54 55
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Contents
4.6.6 4.6.7
Setting the FLEX position ... 55 Setting the REFLEX position ... 56
5
Operation and use... 57
5.1
General ...
57
5.2
OR table ... 5.2.1 Acoustic signals ... 5.2.2 Setting up equipotential bonding... 5.2.3 Status indicators mains connection / battery charge state... 5.2.3.1 Charging batteries (mains operation) ... 5.2.3.2 Battery operation ... 5.2.4 Displace/lock the OR table...
57 57 58 58 59 60 61
5.3
Table tops and accessories ... 5.3.1 Table width extension (1001.75A0/76A0) ... 5.3.2 Moving the table top longitudinally... 5.3.3 Mounting/removing the extension plate (1131.31B0) ... 5.3.4 Head rest (1130.64G0) ... 5.3.4.1 Mounting the head rest to/removing it from the extension plate (1131.31B0)... 5.3.4.2 Positioning the head rest... 5.3.4.3 Mounting the head rest to/removing it from the back plate or leg plate mounting point... 5.3.5 Pair of leg plates (1133.53BC)... 5.3.5.1 Mounting/removing the pair of leg plates ... 5.3.5.2 Abducting the pair of leg plates ... 5.3.6 Mounting/removing pads...
61 61 63 64 64 65 66 66 69 69 70 70
5.4
Explanation of instructions for use... 71 5.4.1 CENTRAL position... 71 5.4.2 Transport position ... 71
6
Table top configurations ... 72
6.1
Table top configuration with overall load of up to 135 kg ... 6.1.1 Usage-related restrictions for up to 135 kg ... 6.1.2 NORMAL patient orientation ... 6.1.3 REVERSE patient orientation ...
73 73 74 76
6.2
Table top configuration for an overall load of 135 kg to 250 kg... 6.2.1 Usage-related restrictions for 135-250 kg... 6.2.2 NORMAL patient orientation ... 6.2.3 REVERSE patient orientation ...
77 77 78 79
6.3
Table top configuration for an overall load of 250 kg to 360 kg... 80 6.3.1 Usage-related restrictions for 250-360 kg... 80 6.3.2 NORMAL and REVERSE patient orientation... 81
7
Cleaning and disinfection ... 82
7.1
General information ... 82 7.1.1 No mechanical preparation ... 83 7.1.2 Padding... 83
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Contents
7.2
Prepare the OR table for cleaning ...
84
7.3
Clean and disinfect the swivel castors...
84
7.4
Cleaning agents and disinfectants... 7.4.1 Suitable cleaning agents... 7.4.2 Suitable disinfectants ... 7.4.3 Non-usable products / substances...
85 85 85 85
7.5
Manual preparation... 7.5.1 Pre-cleaning... 7.5.2 Disinfection ... 7.5.3 Drying... 7.5.4 Inspections...
86 86 86 86 86
8
Maintenance ... 87
8.1
Visual and functional inspections ...
87
8.2
Faults and troubleshooting ...
89
8.3
Inspection and Maintenance...
89
8.4
Maintenance of corded hand controls ...
90
8.5
Repair ...
90
8.6
Type plate position ...
90
8.7
Spare parts ...
91
8.8
Setting the mains voltage ...
92
8.9
Exchanging the fuse ...
93
9
Technical specifications... 95
9.1
General specifications ...
95
9.2
Ambient conditions ...
95
9.3
Electrical specifications ...
95
9.4
Weights...
96
9.5
Dimensions ...
96
9.6
Slope and lateral tilt ...
97
9.7
Back plate ...
97
9.8
Longitudinal shift...
98
9.9
FLEX position ...
98
9.10 REFLEX position ...
99
9.11 Abduction of leg plate mounting point ...
99
9.12 Abduction of a pair of leg plates (1133.53BC)... 100 9.13 Electromagnetic compatibility (EMC)... 101 9.13.1 Electromagnetic emissions ... 101 9.13.2 Resistance to electromagnetic interference... 101 9.13.3 Resistance to electromagnetic interference, non-life-sustaining equipment... 103 9.13.4 Recommended separation distances... 104
10
Approved accessories... 105
10.1 Table structure... 105
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Contents
10.2 Maximum overall load 135 kg ... 106 10.2.1 Protrusion with a NORMAL patient orientation ... 106 10.2.1.1 Overall load up to a maximum of 135 kg, NORMAL mounting point... 106 10.2.1.2 Overall load up to a maximum of 135 kg, REVERSE mounting point ... 108 10.2.2 Protrusion with a REVERSE patient orientation ... 111 10.2.2.1 Overall load up to a maximum of 135 kg, NORMAL mounting point... 111 10.2.2.2 Overall load up to a maximum of 135 kg, REVERSE mounting point ... 112 10.3 Maximum overall load 155–250 kg ... 114 10.3.1 Protrusion with a NORMAL patient orientation ... 114 10.3.1.1 Overall load maximum of 250 kg, NORMAL mounting point... 115 10.3.1.2 Overall load up to a maximum of 250 kg, REVERSE mounting point ... 117 10.3.2 Protrusion with a REVERSE patient orientation ... 120 10.3.2.1 Overall load up to a maximum of 250 kg, NORMAL mounting point... 120 10.3.2.2 Overall load up to a maximum of 250 kg, REVERSE mounting point ... 123 10.4 Maximum overall load 360 kg ... 126 10.4.1 Protrusion with a NORMAL patient orientation ... 126 10.4.2 Overall load up to a maximum of 360 kg, NORMAL mounting point ... 126 10.4.3 Overall load up to a maximum of 360 kg, REVERSE mounting point... 126 10.5 Control devices ... 126 10.6 Side rail accessories... 127
Index... 128
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Contents
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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 EMC EN SN EEC IR INT IPS LED OR table PUR SELV SFC UL
1.1.2
Electromagnetic compatibility European standard Serial no. European Economic Community Infrared Intermittent Internal Power Source Light-Emitting Diode Operating table Polyurethane integral foam Safety Extra Low Voltage Soft Foam Core (special foam core) Underwriters Laboratories Inc.
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
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1
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
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:
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Descriptor
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
1118.06B0/F0/F1/K0 IFU 1118.06 EN 10
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
Definition of terms for the 3-dimensional coordinate system
1
Frontal plane (horizontal plane)
2
Sagittal plane
3
Transverse plane
Definition of inclination and tilt
Fig. 2:
Definition of inclination and tilt
1
Reverse Trendelenburg
3
Lateral tilt
2
Trendelenburg (head down)
4
Inclination
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1
Introduction How to use these operating instructions
1.1.3.5
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.
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
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Introduction How to use these operating instructions
1
The specific usage-related restrictions are listed in the chapter on tabletop configurations [8 Page 72] in the appropriate sub-chapters. 1.1.3.10
Definition of patient orientation
WARN ING ! 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:
1118.06B0/F0/F1/K0 IFU 1118.06 EN 10
NORMAL patient orientation
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1
Introduction How to use these operating instructions
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
CENTRAL position As of an overall load of 180 kg, the OR table may only be operated if the longitudinal shift of the OR table is in the CENTRAL position. The OR table is in the CENTRAL position if the seat plate 1 is located centrally above the column 2 .
1 2
Fig. 6:
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CENTRAL position
1118.06B0/F0/F1/K0 IFU 1118.06 EN 10
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 ISO 15223-1 standard. Symbol for "Name and address of the authorised representative within the European Community". Symbol for "Name and address of the importer".
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 for "Caution".
Tab. 4:
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Symbols
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1
Introduction Symbols used
Symbols
Labelling Labelling in accordance with the IEC 60601-1 standard. Symbol for "Follow Instructions for use".
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. Labelling in accordance with the EN ISO 15223-1 standard. Symbol for "Date of manufacture".
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".
Tab. 4:
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Symbols
1118.06B0/F0/F1/K0 IFU 1118.06 EN 10
Introduction Disposal
Symbols
1
Labelling Labelling in accordance with the ISO 7000 standard. Symbol for "Top".
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:
Symbols
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.
EN VI RON MENT 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.
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1
Introduction Disposal
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 Overview
1.4
1
Overview 4
3
5
2
1
6 7
9
15 16
8
10 11
12
14
13
13
19 17
Fig. 7:
18
Overview of the OR table (1118.06)
1
Head rest (1130.64G0) (optional)
11 Locking catch for longitudinal shift
2
Extension plate 1131.31B0 (optional)
12 Override control panel
3
Lower back plate
13 Swivel castor
4
Seat plate
14 Locking pedal
5
Pair of leg plates (1133.53BC) (optional)
15 Release bracket for head rest
6
Eccentric lever (for abducting leg plates)
7
Release button (leg plate)
16 Handle screw for securing the head rest (on both sides)
8
Handle screw (for abducting leg plate)
17 Foot switch (1009.81E0/E1) (optional)
9
Connection for equipotential bonding
18 IR remote control (1118.91J0) (optional)
10 IR receiver
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19 Corded control device (1118.90J0) (optional)
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1
Introduction Basic requirements
1.5
Basic requirements
1.5.1
Use in accordance with the intended purpose This product is 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.
NO TE Basic safety aspects for North America market only: CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH BASE STANDARDS: ANSI/AAMI ES60601-1 (2005/(R)2012 + A1:2012, C1:2009/ (R)2012 + A2:2010/(R)2012) - Amendment 1 - Revision Date 2012/08/21; CAN/ CSA-C22.2 No. 60601-1:14 - Edition 3 - Revision Date 2014/03 ADDITIONAL STANDARDS: IEC 60601-2-46: 2016 (Third Edition) CSA CAN/CSAC22.2 No. 60601-2-46:12 (Second Edition) .
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