Instructions for Use
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INSTRUCTIONS FOR USE 1009.69A0/F0 SENSOR DRIVE
GA 1009.69 EN 07
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.
V07 04 26-10-2017
1009.69A0/F0 GA 1009.69 EN 07
Contents
Contents 1
Introduction...
1
1.1
Foreword...
1
1.2
How to use these instructions for use... 1.2.1 Abbreviations... 1.2.2 Symbols... 1.2.2.1 Order number... 1.2.2.2 References... 1.2.2.3 Action and reaction... 1.2.3 Definitions... 1.2.3.1 Design of safety notes... 1.2.3.2 Structure of notes... 1.2.3.3 Definition for 3-dimensional coordinate system... 1.2.3.4 Definition of inclination and tilt... 1.2.3.5 Definition of hazardous location, Zone AP-M... 1.2.3.6 Definition of NORMAL/REVERSE mounting point... 1.2.3.7 Definition of direction of travel...
1 1 1 1 1 2 2 2 2 3 3 4 4 5
1.3
Symbols used...
6
1.4
Disposal... 1.4.1 General... 1.4.2 Packaging... 1.4.3 Batteries and rechargeable batteries... 1.4.4 Maquet products... 1.4.5 Used electrical devices...
8 8 8 8 8 8
1.5
Overview...
9
1.6
Basic requirements... 1.6.1 Use in accordance with the intended purpose... 1.6.2 Applicable standards... 1.6.3 Intended purpose... 1.6.3.1 SENSOR DRIVE... 1.6.3.2 Charging unit (1009.70A0) / Charging station (1009.71A0/B0)... 1.6.4 Product features... 1.6.4.1 Key performance characteristics...
10 10 10 10 10 11 11 11
2
Safety notes...
12
2.1
General safety notes...
12
2.2
Safety notes for the product...
14
2.3
Safety notes EMC... 14
3
Initial operation... 16
3.1
Recharging the battery... 3.1.1 General... 3.1.2 Mobile charging unit (1009.70A0)... 3.1.3 Stationary charging unit (1009.71A0/B0)...
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I
Contents
4
Operation and use...
19
4.1
General... 19
4.2
Acoustic signals... 19
4.3
Charge SENSOR DRIVE... 20
4.4
Mounting and removing the SENSOR DRIVE... 21
4.5
User interface...
4.6
Assign SENSOR DRIVE to an OR table... 23 4.6.1 Synchronise SENSOR DRIVE with OR table/ TEACH mode... 24
4.7
Operating functions... 4.7.1 Adjust the travel direction... 4.7.2 Check button lights and LEDs / activate SENSOR DRIVE... 4.7.3 Moving the OR table... 4.7.3.1 Immobilise (LOCK) / release [UNLOCK] the OR table... 4.7.3.2 Move the OR table forward... 4.7.3.3 Move OR table backwards... 4.7.4 Adjust the table top... 4.7.4.1 Inclining the table top... 4.7.4.2 Raising / lowering the table top...
5
Cleaning and disinfection... 31
5.1
General... 5.1.1 Basic notes... 5.1.2 Stainless steel surfaces... 5.1.3 No mechanical decontamination...
31 31 32 32
5.2
Cleaning... 5.2.1 General... 5.2.2 Cleaning procedure... 5.2.3 Cleaning the release button and groove...
33 33 33 34
5.3
Disinfection... 5.3.1 General... 5.3.2 Suitable disinfectants... 5.3.3 Disinfection procedure...
35 35 35 35
6
Maintenance... 36
6.1
Visual and functional inspections...
36
6.2
Maintenance...
37
6.3
Malfunctions and troubleshooting... 37
6.4
Repair...
6.5
Type plate... 38
7
Technical specifications...
39
7.1
General specifications...
39
7.2
Ambient conditions...
39
7.3
Electrical specifications...
40
7.4
Dimensions... 40
II
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25 25 26 26 28 28 29 30 30 30
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Contents
7.5
Weight...
7.6
Electromagnetic compatibility (EMC)... 41 7.6.1 Electromagnetic emissions... 41 7.6.2 Resistance to electromagnetic interference... 41 Index...
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III
Contents
IV
1009.69A0/F0 GA 1009.69 EN 07
Introduction Foreword
1
Introduction
1.1
Foreword
1
Your facility has selected the leading-edge medical technology made by Maquet. We sincerely appreciate the trust you have placed in us. Maquet is a member of the GETINGE Group, which consistently aims for pace-setting solutions in medical technology. Maquet is regarded, around the world, as one of the leading suppliers of equipment for emergency rooms, operating theatres and intensive care units. Ever since the company was founded in 1838, Maquet has been synonymous with innovations and technical progress in medical technology. Solutions relevant to the needs of practice and customer-oriented services optimise work processes and boost economy in hospitals all to the benefit of the patient. 1.2
How to use these instructions for use These instructions for use are provided to familiarise you with the features of this Maquet product. The instructions for use are divided into separate chapters. Please note: • Read these instructions for use through carefully and completely before using the product for the first time. • Always proceed in accordance with the information provided in these instructions for use. • Store these instructions for use in the vicinity of the product.
1.2.1
Abbreviations EC EMC EN IR INT IPS OR OR table SELV SN VDE
1.2.2
Symbols
1.2.2.1
Order number
European Community Electromagnetic compatibility European standard Infrared Intermittent Internal Power Source Operating room Operating table Safety Extra Low Voltage Serial no. Verband der Elektrotechnik Elektronik Informationstechnik
An "X" in the order number (e.g. 1122.33X4) is a placeholder for a number of variants. 1.2.2.2
References References to other pages in this manual are identified with a double arrow symbol " ".
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Introduction How to use these instructions for use
1.2.2.3
Action and reaction The symbol " " identifies an action taken by the user, whereas the "✓" symbol identifies the reaction which this will induce in the system. Example: x Turn on the light switch. ü Lamp lights up.
1.2.3
Definitions
1.2.3.1
Design of safety notes Pictogram
Descriptor
Text
DANGER!
The text for the safety note describes the type of risk and how to prevent it.
Indicates a direct and immediate risk to persons, which may be fatal or result in most serious injury. WARNING! Indicates a potential risk to persons or property which may result in health hazard or grave property damage. CAUTION! Indicates a potential risk to property which may result in property damage. Tab. 1:
1.2.3.2
Design of safety notes
Structure of notes Notes not referring to personal injury or property damage are structured as follows: Pictogram
Tab. 2:
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Structure of notes
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.
Introduction How to use these instructions for use
1.2.3.3
1
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:
Definition of terms for the 3-dimensional coordinate system
1 Frontal plane (horizontal plane)
3 Transverse plane
2 Sagittal plane
1.2.3.4
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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Introduction How to use these instructions for use
1.2.3.5
Definition of hazardous location, Zone AP-M The medical environment is designated as "Zone AP-M" (1).
1
Fig. 3:
1.2.3.6
Hazardous location, Zone AP-M
Definition of NORMAL/REVERSE mounting point The mounting points on mobile operating tables are determined as follows: • NORMAL mounting point (1) • REVERSE mounting point (2)
1
Fig. 4:
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Definition of NORMAL/REVERSE mounting point
2
Introduction How to use these instructions for use
1.2.3.7
1
Definition of direction of travel
1
Fig. 5:
2
The direction of travel depends on the position of the SENSOR DRIVE in relation to the table top. • (1) Definition of forwards travel in the direction of the REVERSE mounting point: SENSOR DRIVE is mounted to the front end of the NORMAL mounting point. • (2) Definition of forwards travel in the direction of the NORMAL mounting point: SENSOR DRIVE is mounted to the front end of the REVERSE mounting point.
Definition of direction of travel
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1 1.3
Introduction Symbols used
Symbols used Symbols
Identification Labelling of products of Class I that have been developed and distributed in accordance with directive 93/42/EEC regarding medical products.
Labelling for UL-Recognized Components
Labelling in compliance with the ISO 15223-1 standard. Symbol for "Product number".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Serial number".
Designation in accordance with the ISO 15223-1 standard. Symbol for "Name and address of the manufacturer as well as date of manufacture".
Identification of devices incorporating a Type B applied part as defined in the IEC 60601-1 standard. Degree of protection against electrical shock.
Symbol for "Follow Instructions for use"
Labelling in accordance with the ISO 15223-1 standard. Symbol für "Observe the instructions for use".
Marking according to the standard ISO 15223-1. Symbol for "Pay attention to the supplied documents".
Labelling as per 2002/96/EU Directive (Directive on Waste Electrical and Electronic Equipment). Symbol for "Do not dispose of at municipal collection points for used electrical equipment". Tab. 3:
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Symbols
Introduction Symbols used
Symbols
1
Identification Internal Power Source
Labelling in compliance with the IEC 60529 standard. Symbol for "Splash protection".
Packaging label. Symbol for "Keep dry".
Labelling of packaging material. Symbol for "Breakable! Handle with care".
Packaging label. Symbol for "Top".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Temperature limitations".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Relative humidity".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Atmospheric pressure".
Tab. 3:
Symbols
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Introduction Disposal
1.4
Disposal
1.4.1
General Used products or parts thereof may be contaminated. To prevent potential infection, please clean and disinfect the product prior to return/disposal.
1.4.2
Packaging The packing is made of materials compatible with the environment. The packing material may be disposed of by Maquet on request.
1.4.3
Batteries and rechargeable batteries Rechargeable batteries/batteries can be submitted to your regional disposal system.
E NV IRONMEN T Defective rechargeable batteries shall be recycled as per 91/157/EEC. Defective rechargeable batteries may not be opened, disposed of in household waste, burned or thrown in water. Defective rechargeable batteries must be disposed of at local collection points.
1.4.4
Maquet products Maquet will take back used products or those which are no longer in service. Please contact your Maquet representative for more detailed information.
1.4.5
Used electrical devices Within the European Economic Community This product is governed by the 2002/96/EU Directive (Directive on Waste Electrical and Electronic Equipment). This product has not been registered for use in private households. Disposal at municipal collection points for used electrical equipment is not authorised. Please contact your Maquet representative for more detailed information on correct and legal disposal. Outside the European Economic Community When disposing of this product, ensure compliance with the applicable national regulations on the handling and disposal of used electrical equipment.
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Introduction
1
Overview
1.5
Overview
1
2
3
6
Fig. 6:
4 5
Overview SENSOR DRIVE (1009.69X0)
1 Control panel
4 Side rail mounting point
2 Throttle grip
5 Locking tab
3 Release key
6 Locking screw
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1
Introduction Basic requirements
1.6
Basic requirements
1.6.1
Use in accordance with the intended purpose This product is an active Class I medical device according to the Medical Device Directive 93/42/ ECC, which will have to be entered in the medical device log. In accordance with the above-mentioned directive, the only persons who may operate this product are those who have been instructed, by authorized personnel, in the use of the product. This product is to be used exclusively in human medicine. Patients may be placed on the device and brought into position only under the supervision of medical personnel. Rooms used for medical purposes where surgical procedures are carried out on this product shall comply with VDE Regulation 0100 Part 710 and/or the corresponding local codes. 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.
1.6.2
Applicable standards The product satisfies the basic requirements set forth in Annex I of the 93/42/EEC Directive as drafted by the Medical Devices Council (Medical Devices Directive) as well as the applicable national (German) codes and the Medical Devices Act in Germany. This has also been demonstrated through the application of the corresponding standards, which have been harmonised with the 93/42/EEC Directive.
1.6.3
Intended purpose
1.6.3.1
SENSOR DRIVE The SENSOR DRIVE (1009.69X0) is an optional cordless operating device for the control of the autodrive and for adjusting mobile OR tables with or without patient, immediately prior to, during and after surgical interventions. The SENSOR DRIVE is mounted to the head or foot end of the OR table on the side rail ends. It is preferably operated using the right hand, and a throttle grip is used to regulate the speed of the autodrive, simplifying the forwards and backwards adjustments of the OR table and also supporting manual steering and the various adjustment functions of the OR table. The SENSOR DRIVE is supplied with voltage via rechargeable batteries that must be recharged at regular intervals. 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.
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Introduction Basic requirements
1
Interfaces The SENSOR DRIVE can be used with the following OR tables if the restrictions are taken into consideration: • ALPHAMAXX OR table (1133.12B3), as of SN 01230 with modification kit (3115.3169) • ALPHAMAXX OR table (1133.12F3), as of SN 00196 with modification kit (3115.3169) • ALPHAMAXX OR table (1133.22B3), as of SN 00043 with modification kit (3115.3179) • ALPHAMAXX OR table (1133.22F3), as of SN 00064 with modification kit (3115.3179) • ALPHAMAXX OR table (1133.22B5), up to SN 00481 with modification kit (3115.3189) • ALPHAMAXX OR table (1133.22B5), as of SN 00482 • ALPHAMAXX OR table (1133.22F5), up to SN 00171 with modification kit (3115.3189) • ALPHAMAXX OR table (1133.22F5), as of SN 00172 • YUNO II OR table (1433.02B0/F0) • MEERA OR table (7200.01B2/B0/F2/F0) Variants The product is available in the following versions: • 1009.69A0 with side rail, EU version • 1009.69F0 with side rail, US version 1.6.3.2
Charging unit (1009.70A0) / Charging station (1009.71A0/B0) The batteries for the product are recharged in the charging unit or the charging station. The following versions are available: • Mobile charging unit (1009.70A0) for AC voltages from 100–240 V • Stationary charging unit (1009.71A0) for 24 V AC; wall-mounted • Stationary charging unit (1009.71B0) for AC voltage of 100–240 V
1.6.4
Product features
1.6.4.1
Key performance characteristics The product corresponds to IEC 60601-1 and its collateral standards with the following key performance characteristics: • This product has no essential performance Note: For the use of HF surgery devices in conjunction with the product, the requirements must be met in accordance with IEC 60601-1-2 and IEC 60601-2-46. During the use of HF surgery devices in the vicinity of the product, due to electro magnetic radiation, the essential electrical performance characteristics (adjustment functions) of the system may not be executed or may only be executed at intervals.
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Safety notes General safety notes
2
Safety notes
2.1
General safety notes
D AN GE R ! Danger to life! Hazard caused by inappropriate handling. Strictly observe the user manual(s) of the O.R. table.
D AN GE R ! Potentially fatal! Hazard caused by unauthorized modifications. Modifications at the product are not permitted.
D AN GE R ! Potentially fatal! Risk posed to the patient's vital functions due to incorrect positioning. Position the patient correctly and keep under permanent observation.
W ARNING ! Risk of injury! Improper patient positioning may cause health damage (e. g. decubitus). Position the patient correctly and keep under constant observation.
W ARNING ! Hazard of injury! Only operate Maquet products which are in fully functioning condition. Before usage check to see that the Maquet product is fully functional and in good working order.
W ARNING ! Risk of injury! If the patient is not secured during positioning, when adjusting the OR table or when positioning the patient (particularly when the inclination and/or tilt features are used), then the patient could slip off the table top in an uncontrolled manner or their legs and arms may hang down. Always secure the patient using suitable aids (e.g. straps) and maintain continuous observation.
W ARNING ! 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.
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Safety notes General safety notes
2
W ARNING ! 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.
W ARNING ! 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.
W ARNING ! Risk of injury due to the operating table tipping! If the OR table is not locked during patient transfer, the OR table may tip. Lock the OR table on the ground prior to transferring the patient!
W ARNING ! Risk of infection! If the operating table is used in areas with varying hygienic requirements, there is a risk of infection. Treat the operating table in accordance with the hygiene guideline and the instructions given in the chapter "Cleaning and disinfection".
W ARNING ! Risk of injury! Electrical devices (e. g. mobile phones, radios, magnetic resonance tomographs) may interfere with the functioning of the product when used near the product. Do not use electrical devices that may interfere with the functionality of the product in the vicinity of the product. Observe the specifications in the technical data of the OR table with regard to electromagnetic compatibility (transmission and resistance). Observe the specifications from the technical data for the use of electrical devices and respond to any effects on the device or the product.
W ARNING ! Risk of injury! Magnetic fields with a strength of more than 0,5 mT may impair the function of the product. Do not use the product within the 0,5 mT line.
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2 2.2
Safety notes Safety notes for the product
Safety notes for the product
W ARNING ! Risk of injury caused by unintentional movement! Tubes or cables may wrap around the throttle grip and parts pointing downwards (accessories) may fall on the throttle grip when inclining and thus operate the release button. Do not mount cables, tubes and parts pointing downwards in the immediate vicinity of the throttle grip of the SENSOR DRIVE.
W ARNING ! Risk of injury! Accidental adjustment of the OR table as a result of an unintentional setting to the SENSOR DRIVE. Prior to each operation, remove the SENSOR DRIVE from the side rail and dispose of it at a secure location in order to prevent the unintentional adjustment of the OR table.
W ARNING ! Risk of injury! When setting down the OR table, there is a risk of crushing and shearing to the feet or objects. Before putting down the OR table, make sure there are no objects located under the OR table base. When lowering the OR table, keep sufficient distance to the OR table base.
2.3
Safety notes EMC
W ARNING ! Hazard of injury! Emission of electromagnetic signals of electrical units that are located near the product or directly attached to the product may have a negative impact on the functions of the product. Do not place other electrical units near the product or directly at or on the product. If this cannot be avoided, the product and the electrical units must be monitored and checked for functional problems.
W ARNING ! Risk of injury! In the vicinity of the product, accessories or cables that have not been specified or supplied by Maquet may by way of reinforced electromagnetic radiation or reduced electromagnetic resistance influence the functions of the product. Do not use any other accessories or cables not specified by Maquet.
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