Ama Tech F-LHPAD User manual

Power Assist Leg Holder
Instructions for Use
Product No. F-LHPAD
80028229
Version B

INSTRUCTIONS FOR USE
Document Number: 80028229 Page 2 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 3
FRANÇAIS..................................................................................................................................... 20
DEUTSCH....................................................................................................................................... 38
ITALIANO ...................................................................................................................................... 55
PORTUGUÊS.................................................................................................................................. 73
ROMÂNESC.................................................................................................................................. 90
SRPSKI ......................................................................................................................................... 108
SLOVENSKY ................................................................................................................................ 125
SLOVENŠČINA ........................................................................................................................... 143
ESPAÑOL .................................................................................................................................... 160

INSTRUCTIONS FOR USE
Document Number: 80028229 Page 3 Issue Date: 18 MAR 2020
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.

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
Table of Contents
Power Assist Leg Holder (I-LHPAD)
1. General Information........................................................................................................... 6
Copyright Notice:........................................................................................................ 6
Trademarks:............................................................................................................... 6
Contact Details:.......................................................................................................... 7
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
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
EMC considerations:.................................................................................................. 9
EC authorized representative:.................................................................................... 9
Manufacturing Information:........................................................................................10
2System.............................................................................................................................10
System components Identification:............................................................................10
Product Code and Description:..................................................................................10
List of Accessories and Consumable Components Table:.........................................11
Indication for use:......................................................................................................11
Intended use:............................................................................................................11
Residual risk: ............................................................................................................12
3Equipment Setup and Use:...............................................................................................12
Prior to use:...............................................................................................................12
Setup: .......................................................................................................................12
Device controls and indicators:..................................................................................14
Storage, Handling and Removal Instructions:............................................................14
3.4.1 Storage and Handling: ....................................................................................14
3.4.2 Removal Instruction: .......................................................................................15
Troubleshooting Guide:.............................................................................................15

INSTRUCTIONS FOR USE
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Device Maintenance:.................................................................................................15
4Safety Precautions and General Information:...................................................................15
General Safety Warnings and Cautions: ...................................................................15
Product Specifications:..............................................................................................16
Sterilization Instruction:.............................................................................................17
Cleaning and Disinfection Instruction: .......................................................................17
5List of Applicable Standards:............................................................................................17

INSTRUCTIONS FOR USE
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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
address patient positioning challenges or creating a system to offer safe and effective
surgical site access for the surgical team, we are committed to providing products of
exceptional value and quality.
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.
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).

INSTRUCTIONS FOR USE
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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.
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, or repairs must be performed by an authorized specialist.
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, the users of the device shall first contact their supplier for guidance on
safe disposal protocols.

INSTRUCTIONS FOR USE
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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

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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 device intended 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)
EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]

INSTRUCTIONS FOR USE
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Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
60601-1
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
2System
System components Identification:
Product Code and Description:
F-LHPAD - LEG HOLDER, PWR. ASSIST, DORNIER
Rail
Clamp
Boot Lock
Handle
Squeeze
Handle

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List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this
device.
Name of Accessory
Product Number
Replacement Pad
F-AMA620S0.6S
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.
Indication for use:
The Leg Holder 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.
Intended use:
The Leg Holder 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.
Name of Consumable
Product Number
Urology/ Gyn Fluid Collection System Drapes
F-UC31, F-UC32
Egg Crate foam
F-10150

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Residual risk:
This product complies with relevant performance, safety standards. However,
patient harm from misuse, device, function or mechanical hazards cannot be
completely excluded.
3Equipment Setup and Use:
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.
Setup:
1. Attach the Muranaka stirrups mount to the table rails using the rail clamps
supplied.
2. Position the rail clamps adjacent to the patient’s hip joint. The boots are marked
(on the bottom) for the patient’s left and right.

INSTRUCTIONS FOR USE
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3. Obtain adequate help to place both legs into the stirrups simultaneously, to
adjust for patient leg length, loosen boot lock handle and gently slide boot up
or down the bar, slightly flexing the knees. When satisfied with the position, re-
tighten the boot lock handle.
4. The ankle, knee, and opposing shoulder should be maintained in a relatively
straight-line during positioning. Notice that for a typical patient, the thigh and
foot are abducted at approximately the same angle.
5. To reposition the stirrups, squeeze the squeeze handle together. When you have
reached the desired degree of lithotomy and or abduction simply release the
handle.
6. Perform a final check to ensure that the patient’s heels are properly seated in
the heels of the Boots and that there are no pressure points on the calf. The leg
must be centered in the Boot to eliminate pressure on the peroneal nerve.
Secure the pad. Over tightening the Velcro strap serves no benefit and can
cause damages to the strap/ pad. Gently secure the strap to the boot, never
pulling it at an angle.

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Device controls and indicators:
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.
Attach Rail Clamp at
Patient Hip Joint and
Mount Stirrup. Handles
Should Mount on the
Outside. The Boot Should
Cradle the Upper Calf.
Squeezing the One-
Touch Control Handle
Counter-Clockwise
Unlocks and Controls
the Abduction,
Adduction and
Lithotomy Controls of
the Stirrup.
Loosen Control Handle
to Adjust Flexion,
Extension, Abduction,
Adduction and
Rotation.
Ensure Control
Handles Are Tight.
Ensure Rail Clamp with
Stirrup Mounted is
Aligned with Patient’s
Hip. Toe, Knee and
Opposing Shoulder
Should Be Aligned.
This Symbol Represents the Patient’s Right foot
This symbol represents the patient’s Left foot

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3.4.2 Removal Instruction:
a. Lower stirrups by squeezing the release handles, and simultaneously downstage
the legs slowly to the desired level.
b. Gently remove patient’s legs from stirrups.
c. Stirrups should be in vertical position for removal from sockets. Loosen
clamp/socket and remove stirrups.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of
the device shall first contact his or her supplier.
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 alcohol wipe 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:
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.
c. To prevent patient and/or user injury and/or equipment damage, examine the
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. 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. Test the locking mechanism to ensure no movement when elevated or
pushed.
e. Read and understand all warnings in this manual and on the device itself prior to
use for patient.
f. Device function should be checked prior to each usage.
g. This device should only be operated by medically trained personnel.
h. The patient's toes may extend beyond the end of the stirrup boot.

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i. The product must be used with compatible clamps.
j. Check for patient contact pressure points and consult the physician before use.
k. Ensure the patient's legs are secure in the boot prior to making adjustments.
l. Use only approved padding.
CAUTION:
a. Do not raise thigh closer to torso than 90º as patient may experience nerve
damage.
b. To prevent patient and/or user injury and/or equipment damage: all
modifications, upgrades, or repairs must be performed by an Allen authorized
specialist. Failure to comply may void warranty.
c. Do not exceed safe working load shown in the product specification table.
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
35 3/4" x 18" x 11 3/4" (91cm x 45.7cm x 30cm)
Material
Stainless Steel, Aluminum and Low
Temperature Polymers
Safe Working Load on the device
350 lbs.(159 kg)
Overall Weight of Complete Device
<44 lbs.(20 kg)
Storage Specifications
Description
Storage temperature
-29°C to +60°C
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
Electrical Specifications
Description
Not Applicable.
Not Applicable.
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Muranaka LegHolder is compatible
with:
a. Clip-On™ Blade Clamp: F-40040(US), F-
40041(EU), F-40042(UK), F-40043(JP)
b. 3-Way Adjustment Clamp: F-TCP2, F-
TCP2(EU)
c. RAIL CLAMP: F-RC2, F-RC29X32MM, F-
RC2XD(DEN), F-RC2X(UK)
d. Or equivalent clamp.

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Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
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
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

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Sl. no
Standards
Description
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

Power Assist Leg Holder
Instructions d'utilisation
Produit N° F-LHPAD
80028229
Version B

INSTRUCTIONS D'UTILISATION
Document Number: 80028229 Page 20 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
INFORMATIONS IMPORTANTES
•Lire et comprendre tous les avertissements dans ce manuel et sur le
dispositif avant de l'utiliser avec un patient.
•Le symbole sert à alerter l'utilisateur de procédures importantes ou
d'instructions de sécurité concernant l'utilisation de ce dispositif.
Le symbole sur les étiquettes sert à indiquer quand il est nécessaire
de se reporter aux instructions d'utilisation.
•Les techniques détaillées dans ce manuel sont uniquement des suggestions
du fabricant. La responsabilité finale des soins au patient en ce qui
concerne ce dispositif incombe au médecin traitant.
•Le fonctionnement du dispositif doit être contrôlé avant chaque utilisation.
•Le dispositif doit être utilisé uniquement par du personnel qualifié.
•Toutes les modifications, mises à jour ou réparations doivent être effectuées
par un spécialiste agréé.
•Garder ce manuel pour référence future.
•Tout incident grave qui survient en lien avec le dispositif doit être signalé au
fabricant et à l'autorité compétente figurant dans le présent document.
Avant d'utiliser ce dispositif ou tout autre dispositif médical avec un
patient, il est recommandé de lire les Instructions d'utilisation et de
se familiariser avec le produit avant son application.