Ama Tech F-10001-F User manual

Basic Stirrup
Instructions for Use
Product No. F-10001-F
80028249
Version B

INSTRUCTIONS FOR USE
Document Number: 80028249 Page 2 Issue Date: 20 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ........................................................................................................................................ 3
中文简体 ...................................................................................................................................... 19
DANSK ........................................................................................................................................ 34
NEDERLANDS ............................................................................................................................. 50
SUOMI ......................................................................................................................................... 67
FRANÇAIS ................................................................................................................................... 83
DEUTSCH ................................................................................................................................... 100
ΕΛΛΗΝΙΚΑ ................................................................................................................................ 117
ITALIANO .................................................................................................................................. 135
日本語版 .................................................................................................................................... 151
한국어 ........................................................................................................................................ 166
NORSK ...................................................................................................................................... 181
POLSKI ....................................................................................................................................... 197
PORTUGUÊS .............................................................................................................................. 214
ROMÂNESC .............................................................................................................................. 231
РУССКИЙ ................................................................................................................................ 248
SRPSKI ....................................................................................................................................... 266
SLOVENSKY .............................................................................................................................. 281
SLOVENŠČINA ......................................................................................................................... 297
ESPAÑOL .................................................................................................................................. 313
SVENSKA ................................................................................................................................... 330
TÜRK .......................................................................................................................................... 346

INSTRUCTIONS FOR USE
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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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Table of Contents
Basic Stirrup (F-10001-F)
1General 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:.................................................................................................10
1.7 EC authorized representative:...................................................................................10
1.8 Manufacturing Information:........................................................................................10
2System.............................................................................................................................11
2.1 System components Identification:............................................................................11
2.2 Product Code and Description:..................................................................................11
2.3 List of Accessories and Consumable Components Table:.........................................12
2.4 Indication for use:......................................................................................................12
2.5 Intended use:............................................................................................................12
2.6 Residual risk: ............................................................................................................13
3Equipment Setup and Use:...............................................................................................13
3.1 Prior to use:...............................................................................................................13
3.2 Setup: .......................................................................................................................13
3.3 Device controls and indicators:..................................................................................14
3.4 Storage, Handling and Removal Instructions:............................................................14
3.4.1 Storage and Handling: ....................................................................................14
3.4.2 Removal Instruction: .......................................................................................14
3.5 Troubleshooting Guide:.............................................................................................14

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3.6 Device Maintenance:.................................................................................................14
4Safety Precautions and General Information:...................................................................15
4.1 General Safety Warnings and Cautions: ...................................................................15
4.2 Product Specifications:..............................................................................................16
4.3 Sterilization Instruction:.............................................................................................16
4.4 Cleaning and Disinfection Instruction: .......................................................................16
5List of Applicable Standards:............................................................................................17

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
1General 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.
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).

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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, 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.

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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

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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
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)

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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]
1.8 Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)

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2System
2.1 System components Identification:
2.2 Product Code and Description:
F-10001-F - BASIC STIRRUP
Support Rod
Table Socket
Leg Positioning Handle

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2.3 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
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.
Name of Consumable
Product Number
Urology/ Gyn Fluid Collection System Drapes
F-UC31, F-UC32
Egg Crate foam
F-10150

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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.
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 boot until the top 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.

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3.3 Device controls and indicators:
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 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).
This Symbol represent the patient‘s Left foot
This Symbol Represent the Patient’s Right foot.

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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.
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. 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.

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4.2 Product Specifications:
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.
Mechanical Specifications
Description
Product Dimensions
30” x 13” x 21 3/4" (76.2cm x 33cm x 55cm)
Material
Stainless Steel, Alloy Steel, Aluminum,
Engineering Polymers, Bronze & Low Density
Polyethylene
Safe Working Load on the device
500 lbs. Patient (226 kg)
Overall Weight of Complete Device
6.7 lbs. Each (3 kg)
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
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-On TM Socket: F-40023(EU),
F-40024(UK), F-ELS(US)
b. Or equivalent clamps.

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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
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

Basic Stirrup
使用说明
产品编号 F-10001-F
80028249
Version B

使用说明
Document Number: 80028249 第19 页Issue Date: 20 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
重要声明
•将设备用于患者之前，请先阅读并了解本手册中以及设备上的所有警告。
•符号用于提醒用户注意有关使用本设备的一些重要操作规程或安全说明。
标签上的 符号旨在提示使用中何时应参考 IFU。
•本手册中详细介绍的技术仅作为制造商的建议。使用本设备进行患者治疗的最终责
任仍由主治医师承担。
•每次使用之前，应检查设备功能。
•本设备仅能由经过培训的人员操作。
•任何修改、升级或维修都必须由经过授权的专业人员执行。
•请保管本手册供日后参考。
•发生与本设备有关的任何严重事故，应报告制造商和此文档所列主管当局。
将本设备或其他类型的医疗仪器用于患者之前，建议您先阅读本 《使用说明》
并熟悉该产品。

使用说明
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Version: B Ref Blank Template: 80025118 Ver. E
目录
Basic Stirrup (F-10001-F)
1一般信息...........................................................................................................................22
1.1 版权声明：................................................................................................................22
1.2 商标：.......................................................................................................................22
1.3 联系信息：................................................................................................................23
1.4 安全注意事项：.........................................................................................................23
1.4.1 安全危险标志说明：........................................................................................23
1.4.2 设备误用说明：...............................................................................................23
1.4.3 用户和/或患者通知：.......................................................................................23
1.4.4 安全弃置：......................................................................................................23
1.5 操作系统：................................................................................................................24
1.5.1 适用符号：......................................................................................................24
1.5.2 适用用户和患者人群： ....................................................................................25
1.5.3 医疗设备法规符合性： ....................................................................................25
1.6 EMC 注意事项： .......................................................................................................25
1.7 EC 授权代表：..........................................................................................................25
1.8 制造信息：................................................................................................................26
2系统..................................................................................................................................26
2.1 系统组件标识：.........................................................................................................26
2.2 产品代码和描述： .....................................................................................................26
2.3 附件列表和耗材组件表：...........................................................................................27
2.4 适用范围：................................................................................................................27
2.5 预期用途：................................................................................................................27
2.6 残留风险：................................................................................................................28