Ama Tech BF855 User manual

JUNIOR POWER-LIFT STIRRUPS
Instructions for Use
Product No. BF855
80028206
Version A

INSTRUCTIONS FOR USE
Document Number: 80028206 Page 2 Issue Date: 18 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 3
БЪЛГАРСКИ................................................................................................................................. 20
ČESKÝ ........................................................................................................................................... 39
DANSK .......................................................................................................................................... 56
NEDERLANDS ............................................................................................................................... 73
EESTI .............................................................................................................................................. 90
SUOMI......................................................................................................................................... 107
FRANÇAIS................................................................................................................................... 124
DEUTSCH..................................................................................................................................... 141
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 159
MAGYAR .................................................................................................................................... 178
ITALIANO .................................................................................................................................... 195
LATVISKI ...................................................................................................................................... 213
NORSK ........................................................................................................................................ 230
POLSKI......................................................................................................................................... 247
PORTUGUÊS................................................................................................................................ 265
ROMÂNESC................................................................................................................................ 282
SRPSKI ......................................................................................................................................... 300
SLOVENSKY ................................................................................................................................ 317
SLOVENŠČINA ........................................................................................................................... 334
ESPAÑOL .................................................................................................................................... 351
SVENSKA..................................................................................................................................... 368

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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.

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Table of Contents
JUNIOR POWER-LIFT STIRRUPS (PAIR) (BF855)
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:...................................................................................10
1.8 Manufacturing Information:........................................................................................10
2. System.............................................................................................................................10
2.1 System components Identification:............................................................................10
2.2 Product Code and Description:..................................................................................11
2.3 List of Accessories and Consumable Components Table:.........................................11
2.4 Indication for use:......................................................................................................11
2.5 Intended use:............................................................................................................11
2.6 Residual risk: ............................................................................................................12
3. Equipment Setup and Use:...............................................................................................12
3.1 Prior to use:...............................................................................................................12
3.2 Setup: .......................................................................................................................12
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:.............................................................................................15

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3.6 Device Maintenance:.................................................................................................15
4. Safety Precautions and General Information:...................................................................15
4.1 General Safety Warnings and Cautions: ...................................................................15
4.2 Product Specifications:..............................................................................................16
4.3 Sterilization Instruction:.............................................................................................17
4.4Cleaning and Disinfection Instruction: .......................................................................17
5. List of Applicable Standards:............................................................................................18

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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.
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 heir 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
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

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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)
1.6 EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.

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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)
[phone] (INTERNATIONAL)
2. System
2.1 System components Identification:
Clamshell Pad
Boot
Blade Mount
Boot Locking Mechanism
Release Handle

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2.2 Product Code and Description:
BF855 - JUNIOR POWER-LIFT STIRRUPS (PAIR)
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
Junior Clamshell Pad
F-10058
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 Junior Stirrup is used in a variety of surgical procedures including, but not limited
to gynecology, urology, laparoscopy, general and robotic surgery. These devices
are appropriate for most pediatric patients ages 7-11, as determined appropriate by
the caregiver or institution.
2.5 Intended use:
The Junior 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
F-UC4 (US), F-UC4E (EU),
F-UC4UK (UK), F-UCAJ (Japan),
F-UC4DEN (Denyer)

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2.6 Residual risk:
This product complies with relevant performance, safety standards. However,
patient harm from misuse, device, function or mechanical hazards cannot be
completely excluded.
3. Equipment 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.
3.2 Setup:
Prior to setting up the Stirrups, assess the patient for any pre-existing conditions that
might contraindicate the use of leg positioning devices.
1. Position the Rail Clamps adjacent to the patient’s hip.
2. Attach the Stirrup to the table rail by sliding the Stirrup Blade Mount into the
slot on the top of the Rail Clamp. Left and Right Stirrups must be in the exact
same location on opposite sides of the OR table.
NOTE: Ensure Left and Right Stirrups are on the proper side; the Boots are
marked (on the bottom of the Boot) for the patient’s left and right.
CAUTION: Avoid pinching fingers between rail and clamp body.
WARNING: Once the stirrup is placed on the rail, the Rail Clamp must be
tightened securely before use.
Blade
Rail Clamp

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3. Pre-position the Stirrup Boots by loosening the Boot Locking Mechanism and
sliding the Boot along the post until the top end (calf portion) of the Boot is
located approximately at the patient’s mid-calf. Tighten the Boot Locking
Mechanism securely. Repeat above procedure for the other Stirrup.
4. Position Stirrup to be level with the table by squeezing the Release Handle and
moving the Stirrup downward.
To Position the Patients onto the Stirrups:
5. Ensure the patient is positioned on the table in accordance with procedure &
surgeon requirements.
6. Positioning should be performed by 2 staff members. Support each of the
patient’s legs by grasping the heel in one hand and the under-side of the knee
with the other. Gently flex the knees and simultaneously transfer both legs into
the Boots.
7. Ensure the patient’s heels are securely seated in the heels of the Boots.
8. Observe the following general guidelines regarding proper initial leg flexion:
i. When using LOW LITHOTOMY, take care not to hyperextend the leg, while
achieving desired abduction.
ii. When using MEDIUM or HIGH LITHOTOMY, use minimal initial
leg flexion and abduction as both will increase as legs are raised.
iii. 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.
9. To fine tune the Boot position and flexion, support the Boot heel with one hand
and, with the other hand, loosen Boot Locking Mechanism. Use both hands to
support and adjust Boot to desired position. Tighten clamping mechanism
securely.

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10. 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 clinical benefit and
can cause damage to the strap/pad. Gently secure the strap to the boot,
never pulling it at an angle.
11. Grasp and squeeze Release Handles and simultaneously move legs slowly to
desired height, maintaining leg symmetry.
12. Once lithotomy level has been achieved, check for pressure points and, if
necessary, make appropriate adjustments.
NOTE: Patient leg position symmetry can be documented using leg length
indicator markings on the Stirrup posts.
3.3 Device controls and indicators:
The indicators below are placed on the sole of each boot.
This Symbol represent the patient‘s right foot.
This Symbol represent the Patient’s left foot
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. Lower Stirrups by grasping and squeezing the Release Handles and
simultaneously down staging the legs slowly to the desired level. A.O.R.N.

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recommends the lowering and staging process take two full minutes. Gently
remove patient’s legs from Stirrups.
b. Stirrups should be in horizontal position for removal from Rail Clamp slot. Loosen
clamp and remove 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).
4. Safety 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. 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. Once the Stirrup is placed on the rail, the Rail Clamp must be tightened securely
before use.

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i. The patient's toes may extend beyond the end of the stirrup boot.
j. The product must be used with compatible clamps.
k. Check for patient contact pressure points and consult the physician before use.
l. Ensure the patient's legs are secure in the boot 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. Avoid pinching fingers between rail and clamp body.
c. Do not exceed 250 lbs. patient weight.
d. Do not raise patient thigh closer than 90 degrees to torso as patient may
experience nerve damage.
e. To prevent 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.
f. Do not exceed safe working load shown in the product specification table.
Equipment care: When stirrup is being handled, it should be held with two hands. It
should not be held by the Boot or Boot Locking Mechanism.
4.2 Product Specifications:
Mechanical Specifications
Description
Product Dimensions
26” x 14 ½” x 10 ¼” (66cm x 36,8cm x 26cm)
Material
Aluminum, Stainless Steel, Alloy Steel,
Bronze, Engineering polymers
Safe Working Load on the device
250 lbs (113 kg)
Overall Weight of Complete Device
<44 lbs. (<20 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

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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
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Junior Stirrups are compatible with:
a. Clip-On™ Blade Clamp
F-40040 (US), F-40041 (EU),
F-40042 (UK), F-40043 (Japan)
b. Rail Clamp
F-RC2 (US), F-RC2XUK (EU/UK),
F-RC2XD (Denyer), F-RC29X32MM
(Japan), F-RCS (Swiss)

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5. List 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

JUNIOR POWER-LIFT STIRRUPS
Инструкции за употреба
Продуктов № BF855
80028206
Version A

ИНСТРУКЦИИ ЗА УПОТРЕБА
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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.