Instructions for Use
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Instructions for use 1133.90R0 Corded control device
IFU 1133.90 EN 05 2019-12-06
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.
V05 04 06-12-2019
1133.90R0 IFU 1133.90 EN 05
Contents
Contents 1
Introduction ...
5
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 patient orientation...
5 5 5 6 6 6 7 7 8
1.2
Symbols used ...
9
1.3
Disposal ... 1.3.1 Old products... 1.3.2 Packaging ... 1.3.3 Used electrical devices ...
11 11 11 11
1.4
Basic requirements ... 1.4.1 Use in accordance with the intended purpose ... 1.4.2 Applicable standards... 1.4.3 Intended use ... 1.4.4 Mounting points... 1.4.5 Variants... 1.4.6 Product features... 1.4.6.1 Essential performance features... 1.4.6.2 Latex-free materials... 1.4.7 Reportable event...
12 12 12 12 12 13 13 13 13 13
2
Safety notes... 14
2.1
General safety notes ...
14
2.2
Safety notes for the product ...
16
2.3
Safety notes EMC...
16
3
Operation and use... 17
3.1
Notes on use ...
17
3.2
Connecting corded hand controls ...
17
3.3
Attaching the hand control to the side rail ...
18
3.4
Acoustic signals of the control device...
19
3.5
Buttons and functions ... 20 3.5.1 Switching the corded control device on ... 21
3.6
Adjustment functions ... 3.6.1 Set the patient orientation ... 3.6.2 Displace/lock the OR table... 3.6.2.1 Moving/locking the OR table with autodrive ... 3.6.2.2 Moving/locking the OR table without autodrive ...
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Contents
3.6.3 3.6.4 3.6.5 3.6.6 3.6.7 3.6.8 3.6.9 3.6.10 3.6.11 3.6.12 3.6.13
Moving the table top to the horizontal position... Raising / lowering the table top... Incline the table top... Tilting the table top laterally ... Raising / lowering the back plate ... Raising / lowering the leg plate ... Shifting the table top longitudinally ... Adjusting the leg plate individually ... Setting the FLEX position ... Setting the BEACH CHAIR position... Activating and deactivating the operating table lock ...
24 25 25 25 26 26 27 27 28 29 29
4
Cleaning and disinfection ... 30
4.1
General information ... 30 4.1.1 No mechanical preparation ... 31
4.2
Cleaning agents and disinfectants... 4.2.1 Suitable cleaning agents... 4.2.2 Suitable disinfectants ... 4.2.3 Non-usable products / substances...
32 32 32 32
4.3
Manual preparation... 4.3.1 Pre-cleaning... 4.3.2 Disinfection ... 4.3.3 Drying... 4.3.4 Inspections...
33 33 33 33 33
5
Maintenance ... 34
5.1
Visual and functional inspections ...
34
5.2
Maintenance ...
35
5.3
Repair ...
35
5.4
Type plate ...
35
6
Technical specifications... 36
6.1
Ambient conditions ...
36
6.2
Electrical specifications ...
36
6.3
Dimensions ...
36
6.4
Weight ...
36
6.5
Electromagnetic compatibility (EMC)... 37 6.5.1 Disruptive electromagnetic emissions... 37 6.5.2 Resistance to electromagnetic interference... 37
Index... 39
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1133.90R0 IFU 1133.90 EN 05
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 EEC IEC HD INT IPS IR ISO LED OR table SELV SN VDE
1.1.2
Electromagnetic compatibility European standard European Economic Community International Electrotechnical Commission Harmonization document Intermittent Internal Power Source Infrared International Organization for Standardization Light-Emitting Diode Operating table Safety Extra Low Voltage Serial no. Verband der Elektrotechnik Elektronik Informationstechnik
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:
1133.90R0 IFU 1133.90 EN 05
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
1133.90R0 IFU 1133.90 EN 05
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 1.1.3.5
Introduction How to use these operating instructions
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. 3:
NORMAL patient orientation
REVERSE patient orientation The legs are located above the longer section of the OR table base 1 .
1
Fig. 4:
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REVERSE patient orientation
1133.90R0 IFU 1133.90 EN 05
Introduction
1
Symbols used
1.2
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.
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 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. 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".
Labelling in accordance with the ISO 15223-1 standard. Symbol für "Consult instructions for use".
Tab. 4:
1133.90R0 IFU 1133.90 EN 05
Symbols
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1
Introduction Symbols used
Symbols
Labelling Labelling in compliance with the IEC 60529 standard. Symbol for "Splash protection".
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".
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".
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". Tab. 4:
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Symbols
1133.90R0 IFU 1133.90 EN 05
Introduction Disposal
1.3
Disposal
1.3.1
Old products
1
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
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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1
Introduction Basic requirements
1.4
Basic requirements
1.4.1
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. The test levels use conform to those used for professional medical equipment. Operation The operator must ensure that the product is fully functional and in good working order prior to use. 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.
1.4.2
Applicable standards The product meets the basic safety and performance requirements in accordance with the local applicable legal specifications for medical devices.
1.4.3
Intended use The corded hand control (1133.90R0) is an optional corded operating unit for the setting and motorised adjustment of the OR table. The design of the control panel enables individual functions to be implemented during surgical interventions. 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.
1.4.4
Mounting points The corded control device may be used in conjunction with the following OR tables: • OR table ALPHAMAXX (1133.12B1/B3/F1/F3 / 1133.22B1/B3/B4/B5/F1/F3/F4/F5)
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1133.90R0 IFU 1133.90 EN 05
Introduction Basic requirements
1.4.5
1
Variants The product is available in the following versions: • 1133.90R0 with adjustable patient orientation
1.4.6
Product features
1.4.6.1
Essential performance features The product corresponds to IEC 60601-1 and its collateral standards with the following key performance characteristics: • This product has no essential performance Note: The function of the product could be impacted by disruptive electromagnetic emissions from other electrical equipment such that they cannot be carried out or can only be carried out at intervals. This may occur, in particular, when using HF surgical equipment near the product.
1.4.6.2
Latex-free materials All used materials (e.g. materials for pads and straps) are latex free.
1.4.7
Reportable event Any serious incident involving this product must be reported to MAQUET GmbH and, if necessary, to the local competent authority.
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2
Safety notes General safety notes
2
Safety notes
2.1
General safety notes DA NG ER ! Potentially fatal! Risk caused by unauthorised modifications. Modifications at the product are not permitted.
DA NG ER ! Potentially fatal! Danger resulting from improper handling. Always observe the instructions for use for the OR table.
DA NG ER ! Potentially fatal! Risk posed to the patient's vital functions due to incorrect positioning. Position the patient correctly and keep under permanent observation.
DA NG ER ! Potentially fatal! Patient may be endangered as a result of incorrect use. Follow the instructions for use for all accessories.
WARN IN G ! Risk of injury! Improper patient positioning may cause health damage (e. g. decubitus). Position the patient correctly and keep under constant observation.
WARN IN G ! Risk of injury! When adjusting, moving or storing the OR table / 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 rest, back and leg plates. Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.
WARN IN G ! Risk of injury! When adjusting and moving the OR table, the table top or the accessories, collisions may occur with the patient, between the individual products or parts pointing downwards. During the adjustment procedures, always pay attention to the OR table and accessories and avoid collisions. Ensure that tubes, cables and drapes are not trapped.
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Safety notes General safety notes
2
WARN ING ! Risk of burns! The use of high-frequency devices, defibrillators and defibrillator monitors exposes the patient to burn risks due to contact with the metal components in the product or accessories and/or as a result of resting on wet drapes or electrically conductive padding. Avoid any contact between the patient and metal components; never use damp or wet surgical drapes. Be absolutely sure to comply with the manufacturers instructions for use!
WARN ING ! Risk of injury! Faulty or defective products may result in injuries. • Before use, check the proper working order and fully functional state of the product. • Stop using faulty or defective products and inform the Getinge representative.
WARN ING ! Risk of injury! Products / accessories not attached properly may loosen and cause injuries. Ensure that products / accessories are mounted correctly and that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened, also ensure that moving parts are correctly secured.
WARN ING ! Risk of injury! If the patient is not secured, particularly when adjusting/moving, the patient and/or their extremities may slip in an uncontrolled manner. Always secure the patient using suitable aids (e.g. straps) and maintain continuous observation.
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2
Safety notes Safety notes for the product
2.2
Safety notes for the product WARN IN G ! Risk of injury! Magnetic fields with a magnitude greater than 0.5 mT may influence the functionality of the product. Never use the product within the 0.5 mT field.
WARN IN G ! Risk of injury! Whenever the product is mounted and adjusted, there is a danger of pinching and shearing to the staff, patient and accessories. Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.
CA UTIO N ! Property damage! The cable of the control device may be damaged during adjustment procedures. Make sure that the cable is not crushed, trapped or damaged in any other way.
2.3
Safety notes EMC WARN IN G ! Risk of injury! Electromagnetic radiation from electrical devices that are in the vicinity of the product, or directly at/on the product may affect the functions of the product. • Do not place any electrical devices nearby or on the product. • If this is not possible, monitor the product and electrical devices and check for any potential functional faults.
WARN IN G ! Risk of injury! Electromagnetic radiation caused by the use of wireless HF communication devices (e.g. mobile telephones and radios) located in the vicinity of the product may influence the functions of the product. Ensure that the distance between the product and HF communication devices (including the connected control devices and cables) is at least 30 cm.
WARN IN G ! Risk of injury! Using accessories, cables or replacement parts not specified by Getinge may result in increased disruptions or a reduced interference immunity for the product, or may impact the safety of the product. Only use Getinge specified accessories, cables or spare parts.
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Operation and use Notes on use
3
Operation and use
3.1
Notes on use
3
WARN ING ! Risk of injury! Position the mobile OR table on a horizontal floor and lock the castors, both prior to each use and after moving it. •
• • • • •
3.2
As a general principle, do not perform adjustments with two control devices at the same time. In the event that multiple control devices are accidentally used simultaneously, the override control panel and corded controls (e.g. corded control device) take priority over the infrared devices (IR remote control). If equally ranked control devices are used at the same time, adjustment may be interrupted or stopped. Approximately 8 seconds after pressing a button, the corded control device and mobile operating table switch themselves off. If the OR table can be is mobile, only the orientation and inclination of the patient can be set. All the LEDs will flash after the corded control device is switched on (self-test). To execute an adjustment, press the appropriate adjustment button, and hold down until the desired position has been reached. It is recommended to switch on the corded control device by briefly pressing the [RIGHT] or [LEFT] buttons in order to avoid unintentional operating table movements.
Connecting corded hand controls CA UTI ON ! Property damage! The cable of the control device may be damaged during adjustment procedures. Make sure that the cable is not crushed, trapped or damaged in any other way.
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3
Operation and use Attaching the hand control to the side rail
The sockets 1 for the corded control devices and foot switch are located on the left and right sides beside the override operating panel. Connecting a corded control device
1
1. Open the cover 2 of the socket for control devices. 1 1
2
3. Ensure that the plug is properly seated. Ø The corded control device is ready for use.
3
Fig. 5:
3.3
2. Insert the plug 3 into the socket for control devices.
Connecting corded hand controls
Attaching the hand control to the side rail CA UTIO N ! Property damage! Hand controls attached to the side rails may slide when the table top is adjusted and fall down as a result or even trap the cables (in the event of corded hand controls). Remove hand controls from the side rail before adjusting the table top.
1. Attach the bracket 1 to the side rail 2 .
1 2
Fig. 6:
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Mounting the hand control to the side rail
1133.90R0 IFU 1133.90 EN 05
Operation and use Acoustic signals of the control device
3.4
3
Acoustic signals of the control device Acoustic signal
Description Acknowledgement tone ▪ The acknowledgement tone is emitted once, when a button is pressed. Repeated intermittent tone ▪ The repeated intermittent tone will sound when a button is pressed and while the appropriate function is carried out. Continuous tone ▪ The continuous tone is sounded if a button is not pressed correctly.
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3
Operation and use Buttons and functions
3.5
Buttons and functions 1 NORMAL display LED lights in green, setting for NORMAL patient orientation
1
2 NOR./REV. Switch between NORMAL and REVERSE patient orientation
2
3 BACKW. Move OR table backwards
3
4 Press the LOCK key longer than 1 second: Swivel castors are retracted, OR table is immobilised. 5 LEFT Individual adjustment of the left leg plate in conjunction with the buttons [LEG DN.] or [LEG UP] 6 L. FOOT Longitudinal shift of table top towards the foot end 7 BACK DN. Adjustment of the back plate downwards 8 LEG DN. Adjustment of the leg plate downwards 9 FLEX The [Back plate] and [Inclination] functions are executed alternately until the FLEX position is reached.
13 REVERSE display LED lights in orange, setting for 13 REVERSE patient orientation 14 LEVEL Table top is horizontally aligned 14 until the zero-position is reached. 15 15 FORW.
The OR table will be moved for16 wards
4 5 6 7 8
16 Press UNLOCK 17 key longer than 1 second: 18
17 RIGHT 19 Individual adjustment of the right leg plate in conjunction with the buttons [LEG DN.] or 20 [LEG UP]
9
21
10
22
11 12
Swivel castors are extended, OR table can be moved.
18 L. HEAD Longitudinal shift of table top towards the head end
19 BACK UP Adjustment of back plate up23 wards 20 LEG UP 24 Adjustment of leg plate up-
wards
10 TREND. Trendelenburg adjustment (inclination, head down)
21 BEACH. The [Inclination] and [Back plate] functions are executed alternately and then the leg plate is lowered.
11 TILT L. Adjustment of lateral tilt to the left
22 REV. Reverse Trendelenburg (inclination, foot down)
12 DOWN Adjustment of table top downwards
23 TILT R. Adjustment of lateral tilt to the right 24 UP Adjustment of table top upwards
Tab. 5:
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Button occupation and functions of corded control device
1133.90R0 IFU 1133.90 EN 05