Instructions for Use
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Instructions for use 1003.80A0 Leg holder
IFU 1003.80 EN 01 2021-09-07
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.
V01 09 07-09-2021
1003.80A0 IFU 1003.80 EN 01
Contents
Contents 1
Introduction ...
5
1.1
How to use these instructions for use... 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 of maximum permitted weight load...
5 5 5 6 6 6 6
1.2
Symbols used ...
7
1.3
Disposal ... 1.3.1 Old products... 1.3.2 Packaging ...
8 8 8
1.4
Basic requirements ... 1.4.1 Use in accordance with the intended purpose ... 1.4.2 Applicable standards... 1.4.3 Intended use of the leg holder (1003.80A0)... 1.4.4 Interfaces ... 1.4.5 Variants... 1.4.6 Product features... 1.4.6.1 Essential performance... 1.4.6.2 Latex-free materials... 1.4.7 Reportable event...
9 9 9 9 9 9 10 10 10 10
2
Safety notes... 11
2.1
General safety notes ...
11
2.2
Safety notes for the product ...
12
2.3
Safety notes regarding the use of accessories...
13
3
Operation and use... 14
3.1
General ...
14
3.2
Pictorial guide ...
14
3.3
Mounting the clamps ...
15
3.4
Mounting / removing the leg holder ...
16
3.5
Attach the knee crutch to the leg holder ...
16
3.6
Adjusting the leg holder ...
17
3.7
Positioning the patient's leg ...
18
4
Cleaning and disinfection ... 19
4.1
General information ... 19 4.1.1 No mechanical preparation ... 20
4.2
Cleaning agents and disinfectants... 4.2.1 Suitable cleaning agents... 4.2.2 Suitable disinfectants ... 4.2.3 Non-usable products / substances...
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21 21 21 21
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Contents
4.3
Manual preparation... 4.3.1 Pre-cleaning... 4.3.2 Disinfection ... 4.3.3 Drying... 4.3.4 Inspections...
5
Maintenance ... 23
5.1
Visual and functional inspections ...
23
5.2
Maintenance ...
24
5.3
Repair ...
24
5.4
Type plate ...
24
6
Technical specifications... 25
6.1
Ambient conditions ...
25
6.2
Dimensions ...
25
6.3
Weight ...
25
6.4
Adjustment angle ...
26
6.5
Abduction...
27
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1003.80A0 IFU 1003.80 EN 01
Introduction How to use these instructions for use
1
Introduction
1.1
How to use these instructions for use
1
These instructions for use are provided to familiarise you with the features of this 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.
1.1.1
Abbreviations EN IEC ISO SFC SN
1.1.2
European standard International Electrotechnical Commission International Organization for Standardization Soft Foam Core (special foam core) Serial no.
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:
1003.80A0 IFU 1003.80 EN 01
Symbols and formatting
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1
Introduction How to use these instructions for use
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:
1.1.3.3
Descriptor
Descriptor
Text
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.
Structure of notes
Definition of maximum permitted weight load The maximum permitted weight load is calculated using the proportional load of the weight of the patient, plus the additional load posed by side rail accessories, mounted accessories and/or OR personnel.
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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 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 "Consult instructions for use".
Labelling in accordance with the IEC 60601-1 standard. Symbol for "Follow Instructions for use".
Labelling in accordance with the ISO 15223-1 standard. Labelling of packaging materials. Symbol for "Keep dry". Labelling in accordance with the ISO 15223-1 standard. Symbol for "Fragile! Handle with care".
Labelling in accordance with the ISO 7000 standard. Symbol for "Top".
Tab. 4:
1003.80A0 IFU 1003.80 EN 01
Symbols
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1
Introduction Disposal
Symbols
Labelling Labelling in accordance with the ISO 15223-1 standard. Symbol for "Temperature limit".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Atmospheric pressure limitation".
Labelling in accordance with the ISO 15223-1 standard. Symbol for "Humidity 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 avoid potential infection risks, 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.
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Introduction
1
Basic requirements
1.4
Basic requirements
1.4.1
Use in accordance with the intended purpose This product is a medical device. The product is designed solely for the purpose of human medicine. The patient may only be placed and positioned under medical supervision. 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 of the leg holder (1003.80A0) The leg holder with single-handed operation (1003.80A0) is designed for use in combination with the knee crutches (1003.81A0 / 1003.82A0) and the block with latch seat (1003.24A0) for the placement and positioning of the patient immediately prior to, during and after surgical interventions, as well as for examination and treatment. The maximum load placed on the product may not exceed the appropriate proportional weight of a 250 kg patient. 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
Interfaces The leg holder may be mounted to all Maquet OR tables with side rails designed for the maximum permitted overall load of the leg holder.
1.4.5
Variants The product is available in the following versions: • 1003.80A0 Leg holder with single-handed operation
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1
Introduction Basic requirements
1.4.6
Product features
1.4.6.1
Essential performance The product corresponds to IEC 60601-1 and its collateral standards with the following essential performance features: • Provision of adjustment functions • Ensure positioning quality and comfort using sufficient table top surface and appropriate positioning geometry • Ensure positioning quality and comfort using pads • Placement of the patient (or the patient’s body parts) without unwanted movement in case of an initial error.
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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Safety notes General safety notes
2
Safety notes
2.1
General safety notes
2
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 caused by unauthorised modifications. Modifications at the product are not permitted.
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.
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 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! When transporting, when transferring table tops, when adjusting/moving the OR table or transporter, as well as when positioning a patient, there is a risk of crushing and shearing of the personnel, patient and accessories, especially in the vicinity of the positioning modules. Make sure that no one is crushed, sheared or injured in any way, and that accessories do not collide with their surroundings.
WARN ING ! Risk of injury! When adjusting and moving the OR table, the transporter, the table top or the accessories, as well as when carrying out a table top transfer, collisions may occur between the patient and individual products or parts that are pointing downwards. During adjustments, observe the OR table, the transporter, the table top and accessories constantly and avoid collisions. Ensure that tubes, cables and drapes are not trapped.
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2
Safety notes Safety notes for the product
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.
WARN IN G ! 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 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 locking elements (eccentric levers, handle screws, locks etc.) are open, the product/accessory can be moved. Before opening the locking elements, hold the individual items firmly. After every adjustment procedure, ensure that all locking elements are closed.
2.2
Safety notes for the product WARN IN G ! Risk of injury due to material failure! The maximum load placed on the product may not exceed the appropriate proportion of a patient weighing 250 kg.
WARN IN G ! Risk of injury! Loose or loosened securing elements may cause injuries. When mounting, and after every adjustment, tighten all of the locking elements (handle screw, locks, levers, etc.) of the product. Check the firm seating of the locking elements.
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Safety notes Safety notes regarding the use of accessories
2
WARN ING ! 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.
WARN ING ! Risk of OR table tipping! The product influences the centre of gravity of mobile operating tables and mobile/independently manoeuvrable columns of operating table systems. When positioning the patient, observe the instructions for use of the operating table used.
2.3
Safety notes regarding the use of accessories 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! Accessories that are not approved by Maquet for this product, as well as accessories from other manufacturers, may cause injuries. Only use Maquet accessories that have been approved for the product. Accessories made by other manufacturers may only be used after obtaining written permission from Maquet.
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3
Operation and use General
3
Operation and use
3.1
General WARN IN G ! Risk of injury due to overloading! The permitted load of the product depends on the combination of accessories used. The product with the lowest permissible load determines the maximum load in the event that it is combined with other accessories. Refer to the instructions for use of each accessory for the permissible load.
WARN IN G ! Risk of injury! Loose or loosened securing elements may cause injuries. When mounting, and after every adjustment, tighten all of the locking elements (handle screw, locks, levers, etc.) of the product. Check the firm seating of the locking elements.
CA UTIO N ! Property damage! Do not force the leg holder without activating the turning handles.
3.2
Pictorial guide The leg holder is made up of the following components: 1
3 4 Fig. 1:
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1
Knee crutch interface
2
Clamp
3
Closure handle
4
Rotary handle
2
Overview of leg holder
1003.80A0 IFU 1003.80 EN 01
Operation and use Mounting the clamps
3.3
3
Mounting the clamps Mounting the clamps 2
1. Open the drop toggle screw 1 . 4
2. Fit the block 2 to the side rail 3 in such a way that the two upper hooks 4 of the block grip behind the side rail. 3. Move clamp downwards. Ø The clamp is seated fully on the side rail.
1
4. Check for firm seating. 3
Fig. 2:
Mounting the clamps
Fixing the clamp 1
1. Push the clamp 1 against the side rail 2 . 2. Tighten the drop toggle screw 3 firmly. 2
Ø The clamp is locked. 3. Check for firm seating.
3 Fig. 3:
1003.80A0 IFU 1003.80 EN 01
Fixing the clamp
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3
Operation and use Mounting / removing the leg holder
3.4
Mounting / removing the leg holder Mounting the leg holder 1. Open the latch mount 1 by turning the tommy screw 2 .
3 1
2. Insert the leg holder 3 from above as far as it will go into the latch mount on the block. 3. Tighten the Tommy screw firmly.
2
4. Check for firm seating. Ø The leg holder cannot be moved. Removing the leg holder 1. Hold the leg holder in place. Fig. 4:
Mounting / removing the leg holder
2. Open the latch mount 1 by turning the tommy screw 2 . 3. Remove the leg holder 3 from the latch mount on the block by lifting up.
3.5
Attach the knee crutch to the leg holder 1. Press and hold both release buttons 1 at the same time. 2. Insert the pins 2 of the knee crutch in the mount 3 on the leg holder A . 3. Let go of the release button.
B A
2
1
3
4. Move the knee crutch back and forth slightly B . Ø The locking device engages with an audible click. Ø The knee crutch is attached to the leg holder. 5. Check for firm seating.
Fig. 5:
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Mounting the knee crutch
1003.80A0 IFU 1003.80 EN 01
Operation and use Adjusting the leg holder
3.6
3
Adjusting the leg holder CA UTI ON ! Risk of injury caused by uncontrolled movement! If the knee crutch is empty or if only a very low load is present, the leg holder will move up after the rotary handle is opened. Hold the knee crutch tight when opening if it is empty or if only a very low load is present so as to guide the movement. Adjusting the height and side spread
1
1. Pull the rotary handle 1 out, hold it and adjust the leg holder to the desired position. 2. Release the rotary handle at the desired position. Ø The leg holder locks itself to the position set. 3. Ensure that the leg holder is properly seated.
Fig. 6:
Adjusting the height and spread
Set the longitudinal direction and lateral inclination 1. Hold the leg holder 1 with one hand.
1
2. Open the locking handle 2 , hold and adjust the leg holder as required. 3. Close the locking handle. Ø The leg holder is secured in the desired position.
2
Fig. 7:
1003.80A0 IFU 1003.80 EN 01
4. Ensure that the leg holder is properly seated.
Set the longitudinal direction and inclination
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3
Operation and use Positioning the patient's leg
3.7
Positioning the patient's leg Prerequisites: • The knee crutch is attached. • The pad is fitted in the knee crutch and covered with drapes.
1
Positioning the patient's leg 1. Place the patient's leg in the leg holder shell on top of the pad 1 . Ø The heel is positioned correctly. 2
2. Place the upper part of the pad over the patient's leg. 3. Secure the leg of the patient using a retaining strap 2 .
Fig. 8:
Positioning the patient's leg
Ø The patient's leg is secured and not crushed. 4. Check for firm seating.
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Cleaning and disinfection General information
4
4
Cleaning and disinfection The product must be cleaned and disinfected after each use. The product can be wiped down to disinfect it. The product can be classified as a non-critical medical device without increased reprocessing requirements.
4.1
General information DA NG ER ! Risk due to mishandling of cleaning agents and disinfectants! • The entire cleaning process may only be completed by qualified technicians. • For information on concentration, temperature and contact and drying times, refer to the instructions of the detergent and disinfectant manufacturer. • Observe current national and international regulations for hygiene in the medical field. • Observe the cleaning and hygiene regulations of the hospital.
DA NG ER ! Risk of infection! Residues on the product (e.g. blood, secretions etc.) can prevent proper disinfection. • Remove coarse impurities from the product immediately with suitable non-fixing agents. • Adjust the cleaning agent to the disinfectant (using a combination agent if necessary) in order to avoid interactions.
DA NG ER ! Risk of infection! Product may be contaminated. • Always wear gloves when cleaning / disinfecting. • If necessary, take further protective measures.
DA NG ER ! Risk of explosion! Agents containing alcohol can form explosive vapour mixtures and ignite where high-frequency equipment is being used. The cleaning and disinfecting agents must be dried before use. Ensure that there are no alcoholic residues on the product during high frequency use.
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4
Cleaning and disinfection General information
WARN IN G ! Risk of injury! If unsuitable cleaning agents and disinfectants are used, the antistatic property and electrical conductivity of the product may be lost, which are required to prevent electrostatic charges as required by the standard. Only use detergents and disinfectants of the specified active ingredient groups.
CA UTIO N ! Improper cleaning and disinfection can cause property damage! • Observe the manufacturer's instructions for concentrations of cleaning agents and disinfectants • Perform visual and functional inspections after each cleaning and disinfection process.
4.1.1
No mechanical preparation CA UTIO N ! Property damage! Do not use any mechanical cleaning or disinfection processes.
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