Ama Tech F-LHPBMAQNP User manual

Maquet Legholder
Instructions for Use
Product No. F-LHPBMAQNP
80028205
Version B

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 2 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ................................................................................................................................. 3
БЪЛГАРСКИ......................................................................................................................... 18
中文简体............................................................................................................................... 34
HRVATSKI.............................................................................................................................. 50
ČESKÝ................................................................................................................................... 65
DANSK.................................................................................................................................. 80
NEDERLANDS ....................................................................................................................... 95
DEUTSCH............................................................................................................................ 110
EESTI ................................................................................................................................... 126
SUOMI................................................................................................................................ 141
FRANÇAIS .......................................................................................................................... 156
ΕΛΛΗΝΙΚΑ .......................................................................................................................... 172
MAGYAR............................................................................................................................ 189
ITALIANO............................................................................................................................ 204
日本語版 ............................................................................................................................. 219
한국어................................................................................................................................. 234
LATVISKI.............................................................................................................................. 249
LIETUVIŲ.............................................................................................................................. 264
NORSK................................................................................................................................ 279
POLSKI................................................................................................................................ 294
PORTUGUÊS (PORTUGAL).................................................................................................. 310
ROMÂNESC ....................................................................................................................... 325
РУССКИЙ .......................................................................................................................... 341
SRPSKI................................................................................................................................. 358
SLOVENSKY........................................................................................................................ 374
SLOVENŠČINA.................................................................................................................... 390
ESPAÑOL............................................................................................................................ 405
SVENSKA ............................................................................................................................ 421
TÜRK................................................................................................................................... 437

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 3 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
IMPORTANT NOTICES
•Read and understand all warnings in this manual and on the device itself
prior to use with a patient.
•The symbol is intended to alert the user to important procedures or
safety instructions regarding the use of this device.
The symbol on the labels is intended to show when the IFU should be
referenced for use.
•The techniques detailed in this manual are only manufacturer’s suggestions.
The final responsibility for patient care with respect to this device remains
with the attending physician.
•Device function should be checked prior to each usage.
•This device should only be operated by trained personnel.
•All modifications, upgrades, or repairs must be performed by an authorized
specialist.
•Keep this manual available for future reference.
•Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority listed in this
document.
Prior to using this or any other type of medical apparatus with a
patient, it is recommended that you read the Instructions for Use and
familiarize yourself with the product.

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 4 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
Table of Contents
Maquet Legholder (F-LHPBMAQNP)
1. General Information..................................................................................................... 6
1.1 Copyright Notice:..................................................................................................6
1.2 Trademarks:............................................................................................................ 6
1.3 Contact Details:..................................................................................................... 7
1.4 Safety Considerations:........................................................................................... 7
1.4.1 Safety hazard symbol notice:...................................................................... 7
1.4.2 Equipment misuse notice: ........................................................................... 7
1.4.3 Notice to users and/or patients:..................................................................7
1.4.4 Safe disposal: ............................................................................................... 7
1.5 Operating the system:........................................................................................... 8
1.5.1 Applicable Symbols:.................................................................................... 8
1.5.2 Intended User and Patient Population: ...................................................... 9
1.5.3 Compliance with medical device regulations:.......................................... 9
1.6 EMC considerations:.............................................................................................. 9
1.7 EC authorized representative: .............................................................................. 9
1.8 Manufacturing Information:................................................................................ 10
2System......................................................................................................................... 10
2.1 System components Identification:....................................................................10
2.2 Product Code and Description:..........................................................................10
2.3 List of Accessories and Consumable Components Table: ................................ 10
2.4 Indication for use:................................................................................................ 11
2.5 Intended use:....................................................................................................... 11
2.6 Residual risk:......................................................................................................... 11
3Equipment Setup and Use:......................................................................................... 12
3.1 Prior to use:........................................................................................................... 12
3.2 Setup:................................................................................................................... 12
3.3 Device controls and indicators:..........................................................................12
3.4 Storage, Handling and Removal Instructions:.................................................... 13
3.4.1 Storage and Handling:..............................................................................13
3.4.2 Removal Instruction: .................................................................................. 13

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 5 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
3.5 Troubleshooting Guide:....................................................................................... 13
3.6 Device Maintenance:......................................................................................... 13
4Safety Precautions and General Information:........................................................... 13
4.1 General Safety Warnings and Cautions:............................................................ 13
4.2 Product Specifications: ....................................................................................... 14
4.3 Sterilization Instruction:......................................................................................... 15
4.4 Cleaning and Disinfection Instruction:................................................................ 15
5List of Applicable Standards:...................................................................................... 16

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 6 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
1. General Information
AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which is a
subsidiary of Hill-Rom, Inc. (NYSE: HRC), a leading worldwide manufacturer and
provider of medical technologies and related services for the health care industry. As
an industry leader in patient positioning, our passion is improving patient outcomes
and caregiver safety, while enhancing our customers' efficiency. Our inspiration
comes from providing innovative solutions to address our customers' most pressing
needs. We immerse ourselves in our customers' world, to better address these needs
and the daily challenges of their environment. Whether developing a solution to
addresspatient positioningchallengesorcreatinga systemtooffer safe and effective
surgical site access for the surgical team, we are committed to providing products of
exceptional value and quality.
1.1 Copyright Notice:
Revision
© 2019 Allen Medical Systems Inc. ALL RIGHTS RESERVED.
No part of this text shall be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, recording, or by any
information or retrieval system without written permission from Allen Medical
Systems, Inc. (Allen Medical).
The information in this manual is confidential and may not be disclosed to third
parties without the prior written consent of Allen Medical.
1.2 Trademarks:
Trademark information can be found in www.allenmedical.com/pages/terms-
conditions.
Product may be covered by one or more patents. Please consult listing at
www.hill-rom.com/patents for any patent(s).

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 7 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
1.3 Contact Details:
For complains or ordering information, please contact your supplier and refer to
the catalog. All modifications, upgrades, or repairs must be performed by an
authorized specialist.
1.4 Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL
DEGRADATION.
1.4.2 Equipment misuse notice:
Do not use product if package is damaged or unintentionally opened before use.
All modifications, upgrades, orrepairsmust be performed by an authorizedspecialist.
1.4.3 Notice to users and/or patients:
Any serious incident that has occurred in relation to the device should be reported
using the contact details provided in section 1.3 of this Instruction for Use and to the
competent authority of the Member State in which the user and/or patient is
established.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer’s weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
1.4.4 Safe disposal:
Customers should adhere to all federal, state, regional, and/or local laws and
regulations as it pertains to the safe disposal of medical devices and accessories.
If in doubt, theuserof the deviceshall first contact theirsupplierforguidanceon safe
disposal protocols.

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 8 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
1.5 Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Description
Reference
Indicates the device is a medical device
MDR 2017/745
Indicates the medical device manufacturer
EN ISO 15223-1
Indicates the manufacturer’s serial number.
The device serial number is encoded as
1YYWWSSSSSSS.
•YY indicates the year of manufacture. i.e.
118WWSSSSSSS where 18 represents the
year 2018.
•WW indicates the number of the
manufacturing week per a standard shop
calendar. (Leading zeros included.)
•SSSSSSS is a sequential unique number.
EN ISO 15223-1
Indicates the medical device Global Trade
Item Number
21 CFR 830
MDR 2017/745
Indicates the date when the medical device
was manufactured
EN ISO 15223-1
Indicates the manufacturer’s lot code using
the Julian Date yyddd, where yy indicates the
last two digits of the year and ddd indicates
the day of the year. i.e. April 4th, 2019 would
be represented as 19094.
EN ISO 15223-1
Indicates the manufacturer’s catalogue
number
EN ISO 15223-1
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
EN ISO 15223-1
Indicates the device do not contain natural
rubber or dry natural rubber latex
EN ISO 15223-1

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 9 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
Indicates the authorized representative in the
European Community
EN ISO 15223-1
Indicates the Medical Device complies to
REGULATION (EU) 2017/745
MDR 2017/745
Indicates a Warning
IEC 60601-1
Intended to show when the IFU should be
referenced for use
EN ISO 15223-1
1.5.2 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare
professionals involved in the deviceintended procedure. Not intended for Lay
persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight in the
safe working load field specified in the product specification section 4.2
1.5.3 Compliance with medical device regulations:
This product is a non-invasive, Class I Medical Device. This system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device
Regulations (REGULATION (EU) 2017/745)
1.6 EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
1.7 EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 10 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
1.8 Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
[phone] (INTERNATIONAL)
2System
2.1 System components Identification:
2.2 Product Code and Description:
F-LHPBMAQNP- Legholder, Maquet(1005.06B0)
2.3 List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this
device.
Support Rod
Table Socket
Leg Positioning Handle

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 11 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
Name of Accessory
Product Number
Nissen Thigh Straps
F-NTS
Shoulder Supports
F-63500
Urology/ Gyn Fluid Collection System
F-UC4 (US), F-UC4E (EU), F-UC4UK (UK),
F-UC4DEN (Denyer), F-UC4J (Japan)
Polymer Gel Boot Pads
F-10026
Stirrup Cart
F-30015
Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.
2.4 Indication for use:
The Stirrup is used in a variety of surgical procedures including, but not limited to
gynecology, urology, laparoscopy, general and robotic surgery. These devices are
capable of being used with a broad patient population as determined appropriate
by the caregiver or institution.
2.5 Intended use:
The Stirrup is designed to position and support the patient’s foot, lower leg and upper
leg in a variety of surgical procedures including, but not limited to gynecology,
urology, laparoscopy, general and robotic surgery. These devices are intended to
be used by healthcare professionals within the Operating Room setting.
2.6 Residual risk:
This product complies with relevant performance, safety standards. However,
patient or device harm from misuse, device damage, function or mechanical
hazards cannot be completely excluded.
Name of Consumable
Product Number
Urology/ Gyn Fluid Collection System Drapes
F-UC31, F-UC32
Egg Crate foam
F-10150

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 12 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
3Equipment Setup and Use:
3.1 Prior to use:
a. Inspect the product looking for any visible damage or sharp edges that could
be caused by a drop or impact during storage.
b. Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
c. Assess the patient for pre-existing conditions that might preclude the use of
stirrups, such as recent hip surgery.
3.2 Setup:
1. Place the table socket clamps on the surgical table side rails next to the
patient's hip. Insert the lower portion of the mount bar into the clamp. Rotate
the clamp for the degree of lithotomy desired for the stirrup. Tighten the clamp
knob securely.
2. Loosen the boot locking handle one half turn and slide the bootuntil thetop of
the calf portion of the boot is at the patient's midcalf. Tighten the boot locking
handle. Place a foam or gel type pad into the boot.
3. Place the patient's legs into the stirrups by holding the heel with one hand and
lifting underneath the knee with the other. It is recommended that the legs be
placed into the stirrups simultaneously.
4. If repositioning is necessary once the patient is in the stirrups, grasp the heel of
the boot with one hand and loosen the boot locking handle with the other.
Move the boot as required and lock the handle.
5. For maximum patient comfort, align the foot, the knee and the hip with the
opposite shoulder. If possible, place the patient into the stirrups prior to
anesthesia. This will allow the patient to bring any discomfort to your attention.
Post-operative pain can result from improper positioning.
6. Monitoring of the legs during the procedure can be made easier by the use of
see through drapes such as Safety Drapes.
3.3 Device controls and indicators:
This Symbol represent the patient‘s Left foot

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 13 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
3.4 Storage, Handling and Removal Instructions:
3.4.1 Storage and Handling:
The product should be stored in a clean and safe environment to prevent product
damage. See storage Specifications under Product Specification section.
3.4.2 Removal Instruction:
a. Remove the boot straps over the foot pad.
b. Gently remove patient’s legs from Stirrups.
c. Loosen the table socket knobs and remove the stirrups.
3.5 Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of
the device shall first contact his or her supplier.
3.6 Device Maintenance:
Make sure that all labels are installed and can be read. Replace labels as
necessary by using a plastic scraper to remove the label. Use an alcoholwipe to
remove any adhesive residue.
Contact us if you need to repair or replace the device by using the information
from the contact details section (1.3).
4Safety Precautions and General Information:
4.1 General Safety Warnings and Cautions:
WARNING:
a. Do not use if product shows visible damage.
b. Prior to using this device, please read the instructions for equipment set up and
use. Familiarize yourself with the product before application on a patient.
This Symbol Represent the Patient’s Right foot.

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 14 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
c. To prevent patient and/or user injury and/or equipment damage, examinethe
device and surgical-table side rails for potential damage or wear prior to use. Do
not use the device if damage is visible, if parts are missing or if it does not function
as expected.
d. Read and understand all warnings in this manual and on the device itself prior to
use for patient.
e. To prevent patient and/or user injury and/or equipment damage, verify the
device attaching clamps completely touch the table-side rails and are
firmly in place. Apply device only to U.S. standard side rails. Test the locking
mechanism to ensure no movement when elevated or pushed.
f. The patient's toes may extend beyond the end of the stirrup boot.
g. Use product with compatible clamps.
h. Check for patient contact pressure points and consult the physician before use.
i. Secure the patient's legs in the boots prior to making adjustments.
CAUTION:
a. Do not clean stirrup by immersing it in liquid or using high-pressure spray. Such
action may damage product.
b. To avoid patient and/or user injury and/or equipment damage all modifications,
upgrades, or repairs must be performed by an authorized specialist. Failure to
comply may void warranty.
c. Do not exceed safe working load shown in the product specification table.
4.2 Product Specifications:
Mechanical Specifications
Description
Product Dimensions
30” x 13” x 21 3/4" (76,2 cm x 33 cm x 55 cm)
Material
Stainless Steel, Alloy Steel, Aluminum,
Engineering Polymers, Bronze & Low Density
Polyethylene
Safe Working Load on the device
500 lbs. (226 kg pPatient
Overall Weight of Complete Device
6.7 lbs. (3 kg) each
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC
Storage Relative humidity range
15% to 85%
Operating temperature
This device is intended to be used in a controlled
Operating Room environment.
Operating Relative humidity range

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 15 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
Note: Consult the corresponding IFU for the products mentioned in the above table.
4.3 Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
4.4 Cleaning and Disinfection Instruction:
WARNING:
•Do not use bleach or products that contain bleach to clean the device. Injury or
equipment damage can occur.
•After each use, clean the device with alcohol-based wipes.
•Do not put the device into water. Equipment damage can occur.
•Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean
and disinfect the device.
•Read and follow the manufacturer’s recommendation for low-level disinfection.
•Read and follow the cleaning product’s instructions. Use caution in areas where
liquid can get into the mechanism.
•Wipe the device with a clean, dry cloth.
•Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
Electrical Specifications
Description
Not Applicable.
Not Applicable.
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Basic Stirrup is compatible with:
a. Click-OnTM Socket: F-40023(EU),
F-40024(UK), F-ELS(US)
b. Or equivalent clamps.

INSTRUCTIONSFORUSE
Document Number: 80028205 Page 16 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
5List of Applicable Standards:
Sl. no
Standards
Description
1.
EN 62366-1
Medical devices - Part 1: Application of
usability engineering to medical devices
2.
EN ISO 14971
Medical devices- Application of risk
management to medical devices.
3.
EN 1041
Information supplied by the manufacturer of
medical devices
4.
EN ISO 15223-1
Medical devices - Symbols to be used with
medical device labels, labelling and
information to be supplied - Part 1: General
requirements
5.
EN ISO 10993-1
Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk
management process
6.
IEC 60601-2-46
Medical electrical equipment - Part 2-46:
Particular requirements for the basic safety
and essential performance of operating tables
7.
ISTA
International Safe Transit Association standards
for package testing

Maquet Legholder
Инструкции за употреба
Продуктов № F-LHPBMAQNP
80028205

ИНСТРУКЦИИ ЗА УПОТРЕБА
Document Number: 80028205 Страница 18 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118Ver. E
ВАЖНИ СЪОБЩЕНИЯ
•Прочетете и разберете всички предупреждения в това ръководство и по
самото изделие, преди да го използвате с пациент.
•Символът е предназначен да сигнализира на потребителя за важни
процедури или инструкции за безопасност относно използването на
това изделие.
Символът на етикетите е предназначен да показва кога трябва
да се направи справка с инструкциите за употреба (IFU) за
употребата.
•Техниките, описани в това ръководство, са само предложения на
производителя. Окончателната отговорност за грижи за пациента по
отношение на това изделие остава при лекуващия лекар.
•Функцията на изделието трябва да се проверява преди всяка употреба.
•С това изделие трябва да работи единствено обучен персонал.
•Всички модификации, надстройки или ремонти трябва да се
извършват от упълномощен специалист.
•Дръжте това ръководство налично за бъдеща справка.
•Всеки един сериозен инцидент, възникнал във връзка с изделието,
трябва да се докладва на производителя и на компетентния орган,
посочен в този документ.
Преди използването на този или друг тип медицински апарат с
пациент се препоръчва да прочетете инструкциите за
употреба и да се запознаете с продукта.

ИНСТРУКЦИИ ЗА УПОТРЕБА
Document Number: 80028205 Страница 19 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118Ver. E
Съдържание
Maquet Legholder (F-LHPBMAQNP)
1Обща информация................................................................................................. 21
1.1 Съобщение за авторското право:................................................................... 21
1.2 Търговски марки: ............................................................................................... 21
1.3 Данни за контакт:............................................................................................... 22
1.4 Съображения за безопасност:........................................................................ 22
1.4.1 Съобщение за символа за риск за безопасността: .......................... 22
1.4.2 Съобщение за неправилно използване на оборудването: ............... 22
1.4.3 Съобщение за потребителите и/или пациентите:............................... 22
1.4.4 Безопасно изхвърляне: ............................................................................ 23
1.5 Работа със системата:..................................................................................... 23
1.5.1 Приложими символи:..............................................................................23
1.5.2 Целева потребителска и пациентска популация:............................... 24
1.5.3 Съответствие с регламентите за медицински изделия:...................... 24
1.6 Съображения за ЕМС:....................................................................................... 25
1.7 Упълномощен представител за ЕО:................................................................ 25
1.8 Производствена информация:........................................................................ 25
2Система..................................................................................................................... 25
2.1 Идентификация на компонентите на системата:........................................ 25
2.2 Код и описание на продукта:...........................................................................26
2.3Списък с аксесоарите и таблица с консумативи:....................................... 26
2.4 Показание за употреба: ................................................................................... 26
2.5 Предназначение:............................................................................................... 27
2.6 Остатъчен риск: ................................................................................................. 27
3Настройка и използване на оборудването:.......................................................... 27
3.1 Преди използване:............................................................................................. 27
3.2 Настройка:..........................................................................................................27
3.3 Контролни елементи и индикатори на изделието:........................................28
3.4 Инструкции за съхранение, боравене и отстраняване: .............................. 28
3.4.1 Съхранение и боравене:........................................................................ 28
3.4.2 Инструкция за отстраняване:..................................................................29

ИНСТРУКЦИИ ЗА УПОТРЕБА
Document Number: 80028205 Страница 20 Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118Ver. E
3.5 Ръководство за отстраняване на неизправности:.......................................... 29
3.6 Поддръжка на изделието:................................................................................. 29
4Предпазни мерки за безопасност и обща информация:................................. 29
4.1 Общи предупреждения за безопасност и сигнали за внимание: ............. 29
4.2 Спецификации на продукта:........................................................................... 30
4.3 Инструкция за стерилизиране:........................................................................ 31
4.4 Инструкция за почистване и дезинфекция:.................................................... 31
5Списък с приложимите стандарти:........................................................................32