Instructions for Use
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Instructions for use
1975.91A0/B0 IR remote control
IFU 1975.91 EN 01 2019-11-22
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.
V01 03 22-11-2019
1975.91A0/B0 IFU 1975.91 EN 01
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...
5 5 5 6 6 6 7 7
1.2
Symbols used ...
8
1.3
Disposal ... 1.3.1 Old products... 1.3.2 Packaging ... 1.3.3 Batteries and rechargeable batteries ... 1.3.4 Used electrical devices ...
10 10 10 10 10
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...
11 11 11 11 11 12 12 12 12 12
2
Safety notes... 13
2.1
General safety notes ...
13
2.2
Safety notes for the product ...
14
2.3
Safety notes EMC...
15
3
Initial operation ... 16
3.1
Charging of IR remote control ... 16 3.1.1 Recharging the battery in the IR remote control ... 16
3.2
IR code ...
4
Operation and use... 17
4.1
General ...
17
4.2
Notes on use ...
17
4.3
Transmission power ...
17
4.4
Acoustic signals of the control device...
17
4.5
Button assignment and functions ... 18 4.5.1 Special functions: Shorten the automated transfer procedure... 19
1975.91A0/B0 IFU 1975.91 EN 01
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Contents
4.5.2
Special functions: Accelerate belt and plate movements... 20
5
Cleaning and disinfection ... 21
5.1
General information ... 21 5.1.1 No mechanical preparation ... 22
5.2
Cleaning agents and disinfectants... 5.2.1 Suitable cleaning agents... 5.2.2 Suitable disinfectants ... 5.2.3 Non-usable products / substances...
23 23 23 23
5.3
Manual preparation... 5.3.1 Pre-cleaning... 5.3.2 Disinfection ... 5.3.3 Drying... 5.3.4 Inspections...
24 24 24 24 24
6
Maintenance ... 25
6.1
Visual and functional inspections ...
25
6.2
Maintenance ...
26
6.3
Malfunctions and troubleshooting ... 26 6.3.1 IR remote control ... 26
6.4
Repair ...
26
6.5
Type plate ...
27
7
Technical specifications... 28
7.1
Ambient conditions ...
28
7.2
Electrical specifications ...
28
7.3
Dimensions ...
28
7.4
Weight ...
28
7.5
Electromagnetic compatibility (EMC)... 29 7.5.1 Disruptive electromagnetic emissions... 29 7.5.2 Resistance to electromagnetic interference... 29
Index... 31
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1975.91A0/B0 IFU 1975.91 EN 01
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 INT IPS IR ISO LED OR table SELV SN VDE
1.1.2
Electromagnetic compatibility European standard European Economic Community International Electrotechnical Commission 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:
1975.91A0/B0 IFU 1975.91 EN 01
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
1975.91A0/B0 IFU 1975.91 EN 01
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 1.2
Introduction Symbols used
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:
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Symbols
1975.91A0/B0 IFU 1975.91 EN 01
Introduction
1
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:
1975.91A0/B0 IFU 1975.91 EN 01
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
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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1975.91A0/B0 IFU 1975.91 EN 01
Introduction Basic requirements
1.4
Basic requirements
1.4.1
Use in accordance with the intended purpose
1
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 IR remote control (1975.91X0) is an optional cordless operating method for the motorised adjustment of the TRANSMAQUET when transferring patients. The design of the control panel enables individual functions to be implemented during transfer. The product may only be operated by medically trained staff within the OR environment. Any use other than described above is deemed not to be in accordance with the intended use.
1.4.4
Mounting points The IR remote control may be used in conjunction with the following products: • TRANSMAQUET transfer unit (1955.00A0/B0) • TRANSMAQUET transfer unit (1975.00A0/B0/C0/D0)
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1
Introduction Basic requirements
1.4.5
Variants The product is available in the following versions: • 1975.91A0 IR transmitter EU/USA without charging station • 1975.91B0 IR transmitter EU/USA without charging station, 455 kHz
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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1975.91A0/B0 IFU 1975.91 EN 01
Safety notes General safety notes
2
Safety notes
2.1
General safety notes
2
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 operating instructions of the patient transfer unit.
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 ING ! Risk of injury! Improper patient positioning may cause health damage (e. g. decubitus). Position the patient correctly and keep under constant observation.
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.
1975.91A0/B0 IFU 1975.91 EN 01
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2
Safety notes Safety notes for the product
WARN IN G ! 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 IN G ! 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.
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.
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1975.91A0/B0 IFU 1975.91 EN 01
Safety notes Safety notes EMC
2.3
2
Safety notes EMC WARN ING ! 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 ING ! 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 ING ! 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.
1975.91A0/B0 IFU 1975.91 EN 01
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3
Initial operation Charging of IR remote control
3
Initial operation
3.1
Charging of IR remote control NO TE Fully charge the rechargeable batteries of the IR remote control before initial operation.
3.1.1
Recharging the battery in the IR remote control Prerequisite • The supply voltage display 1 is illuminated. 1. Place the IR remote control 2 into the mount on the control panel. Ø The charge controller 3 is illuminated. The battery will be recharged.
3 2
1
Fig. 3:
3.2
Charging the battery in the IR remote control
IR code The IR remote control is assigned specifically to the transfer plate via an electronic code. Authorised personnel carry out the coding and release of the IR remote control and transfer plate. The IR remote control and associated transfer plate are marked with adhesive labels where the set IR code can be read off. The left side of the IR code consists of the code number 0, while the right side consists of the code numbers 1-8.
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1975.91A0/B0 IFU 1975.91 EN 01
Operation and use General
4
Operation and use
4.1
General
4
In order to ensure trouble-free transfers, the transfer unit (1975.00X0, 1955.00X0) is fitted with an automated transfer procedure that can only be started via the IR remote control. This transfer procedure supports the operating personnel with automated functional processes and interrupts the transfer process at certain points. These interruptions are not faults, but instead a fixed component of the transfer procedures and will be shown on the display. The transfer process may also be carried out manually without the procedure. In the event that the IR remote control fails, the transfer procedure may also be carried out manually using the operating panel.
4.2
Notes on use • •
•
4.3
The capacity of the fully charged rechargeable battery is sufficient for several days of OR operation. The IR remote control is charged in the charging unit . In order to prevent the rechargeable battery from running out during OR operation, it is recommended to store the IR remote control in the charger or charging unit when it is not in use. If the rechargeable battery is low, a signal tone will sound whenever a button is pressed.
Transmission power The transmission performance of the IR remote control is sufficient to adjust the draped OR table from a greater distance. When the desired adjustment of the OR table is not executed when the button is pressed (status icon for signal exchange between OR table and IR remote control does not appear), the direction in which the IR remote control is pointing or the position of such should be modified slightly. In this case, the infrared receiver on the column is shielded (e.g. by a person).
4.4
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.
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4
Operation and use Button assignment and functions
Acoustic signal
Description Intermittent tone ▪ Intermittent tone is sounded when a button is pressure and the rechargeable battery of the IR remote control only has very little charging capacity left. Continuous tone ▪ The continuous tone is sounded if a button is not pressed correctly.
4.5
Button assignment and functions
1
10
2 3
11
4
12
5
1
[Patient to OR] button, automated transfer procedure
2
[Shorten transfer procedure]] button
3
[Belt towards bed] button
4
[Pick up patient from bed] button
5
[Patient to OR] button
6
[Patient to bed] button
7
[Place patient on bed] button
8
[Transfer plate down] button
9
IR code, 1. Position
10 [Patient to bed] button, automated transfer procedure 11 [Belt to OR] button
6 7
13
8
14
12 [Place patient on OR table] button 13 [Pick-up patient from OR table] button 14 [Transfer plate up] button 15 [Faster] button
15
9
16 IR code, 2. Position
16
1 Fig. 4:
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Button assignment for the IR remote control (1975.91A0/B0)
1975.91A0/B0 IFU 1975.91 EN 01
Operation and use Button assignment and functions
4.5.1
4
Special functions: Shorten the automated transfer procedure Shorten the automated transfer procedure In order to further accelerate the automated transfer procedure, individual steps may be shortened. 3
2
1
1. Simultaneously press [Shorten transfer procedure]] 1 and the [Patient to OR] 2 , automated transfer procedure button or [Shorten transfer procedure]] 1 and [Patient to bed] 3 , automated transfer procedure buttons. Ø The relevant movement is stopped if the procedure program permits. Ø The system moves immediately to the next movement. Ø The process is acknowledged with an acousticsignal.
1
Fig. 5:
1975.91A0/B0 IFU 1975.91 EN 01
Special functions
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4
Operation and use Button assignment and functions
4.5.2
Special functions: Accelerate belt and plate movements NO TE The adjustment speed cannot be increased in conjunction with the [Transfer plate down] and [Transfer plate up] buttons.
Accelerate belt and plate movements To further accelerate the transfer procedure, the transfer plate and the transport belt may be operated at a higher speed. 1. Press one of the adjustment buttons 1 and the [Faster] 2 button simultaneously and hold down. Ø The transfer plate or belt will be moved at a higher speed (as long as the buttons remain pressed). 1
2
1 Fig. 6:
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Special functions
1975.91A0/B0 IFU 1975.91 EN 01