Skytron F-LHHDSKY User manual

Skytron Bariatric Leg Holders
Instructions for Use
Product No. F-LHHDSKY
80028208
Version A

INSTRUCTIONS FOR USE
Document Number: 80028208 Page 2 Issue Date: 18 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E

INSTRUCTIONS FOR USE
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Version: A Ref Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 4
EESTI .............................................................................................................................................. 20
FRANÇAIS..................................................................................................................................... 36
DEUTSCH....................................................................................................................................... 53
ITALIANO ...................................................................................................................................... 71
LATVISKI ........................................................................................................................................ 88
LIETUVIŲ ...................................................................................................................................... 104
POLSKI......................................................................................................................................... 120
ROMÂNESC................................................................................................................................ 136
SRPSKI ......................................................................................................................................... 154
SLOVENSKY ................................................................................................................................ 171
SLOVENŠČINA ........................................................................................................................... 188
ESPAÑOL .................................................................................................................................... 206

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.

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Table of Contents
Bariatric Leg Holders,Skytron (F-LHHDSKY)
1. General Information............................................................................................................ 7
Copyright Notice: ........................................................................................................ 7
Trademarks:................................................................................................................... 7
Contact Details: ........................................................................................................... 7
Safety Considerations:................................................................................................. 8
1.4.1 Safety hazard symbol notice: .......................................................................... 8
1.4.2 Equipment misuse notice: ................................................................................ 8
1.4.3 Notice to users and/or patients:...................................................................... 8
1.4.4 Safe disposal: ..................................................................................................... 8
Operating the system:................................................................................................. 8
1.5.1 Applicable Symbols:.......................................................................................... 8
1.5.2 Intended User and Patient Population:........................................................ 10
1.5.3 Compliance with medical device regulations: .......................................... 10
EMC considerations:.................................................................................................. 10
EC authorized representative: ................................................................................. 10
Manufacturing Information: ..................................................................................... 10
2System ................................................................................................................................. 11
System components Identification:......................................................................... 11
Product Code and Description:............................................................................... 11
List of Accessories and Consumable Components Table:................................... 11
Indication for use: ...................................................................................................... 12
Intended use:.............................................................................................................. 12
Residual risk: ................................................................................................................ 12
3Equipment Setup and Use:............................................................................................... 12
Prior to use:.................................................................................................................. 12
Setup:........................................................................................................................... 13
Device controls and indicators:............................................................................... 14
Storage, Handling and Removal Instructions:........................................................ 15
3.4.1 Storage and Handling: ................................................................................... 15
3.4.2 Removal Instruction:........................................................................................ 15

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Troubleshooting Guide:............................................................................................. 15
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

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1. General Information
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).
Contact Details:
For ordering information please see catalog.
Customer service Information:
Phone Number: Address:
1-800-759-8766 5000 36th Street SE
Grand Rapids, MI 49512

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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.
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

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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
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

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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]
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
System components Identification:
Product Code and Description:
F-LHHDSKY - Bariatric Leg Holders,Skytron
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
Urology/ Gyn Fluid Collection System
F-UC4 (US), F-UC4E (EU), f-UC4UK (UK),
F-UC4DEN (Denyer), F-UC4J (Japan)
Bariatric Nissen Thigh Straps
F-NTSHD
Polymer Gel Boot Pads
F-10026
Stirrup Cart
F-30015
Boot System
Boot Lock
Handle
Gas Spring
Clamp
Release
Handle
OR Table

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

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Setup:
a. The leg holders mount to the table rails using standard rail clamps.
b. Locate clamps adjacent to the patient’s hip joint. The boots are marked (on
the bottom) for the patient’s left and right.
c. Obtain adequate help to place both legs into the leg holders simultaneously.
d. To adjust for patient leg length, loosen boot lock handle and gently slide boot
up or down the bar, slightly flexing the knees.

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e. Then, when satisfied with the position, re-tighten the boot lock handle.
f. T.K.O. = The toe, knee and opposing shoulder should be maintained in relatively
straight-line during positioning. Notice that for a typical patient, the thigh and
foot are abducted at approximately the same angle.
g. Twist Handle: To reposition the leg holders grasp the handle palms down and
twist with your thumbs going up toward the ceiling. When you have reached
the desired degree of lithotomy and or abduction simply release the handle.
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

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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 Twisting the 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 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.

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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. Whenever practical, a patient should be placed in the leg holders prior to
anesthesia. An alert patient can communicate normal range of motion limitations
and, to some extent, such patient’s opposing muscles will guard against abnormal
joint moving and stretching.
f. The patient's toes may extend beyond the end of the stirrup boot.
g. The product must be used with compatible clamps.
h. check for patient contact pressure points and consult the physician before use.
i. Warn the user against using non-approved padding.
j. To secure the patient's legs in the boots prior to making adjustments.
CAUTION:
a. Keep patient and caregivers away from the area between the gas spring and the
main support tube. Possible pinch point hazard when in extreme high lithotomy.
b. Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
38" x 21" x 12" (96.5cm x 53cm x 30.5cm)
Material
Stainless Steel, Alloy Steel, Aluminum,
Engineering Polymers, Bronze
Safe Working Load on the device
720 lbs (326 kg)
Overall Weight of Complete Device
14.8 lbs. Each(6.7 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 Bariatric Power-Lift Stirrup is
compatible with:
Clip-on TM Blade Clamp:
F-40040(US), F-40041(EU), F-40042(UK),
F-40043(JP)

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Note: Consult the corresponding IFU for the products mentioned in the above table.
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

Skytron Bariatric Leg Holders
Kasutusjuhend
Toote nr F-LHHDSKY
80028208
Version A

KASUTUSJUHEND
Document Number: 80028208 Lehekülg 20 Issue Date: 18 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E
OLULISED MÄRKUSED
•Enne seadme patsiendil kasutamist lugege läbi kõik selles juhendis
ja seadmel endal olevad hoiatused ning tehke need endale selgeks.
•Sümbol teavitab kasutajat tähtsatest seadme kasutamisega seotud
tööjuhistest või ohutusjuhistest.
Märgistusel olev sümbol tuletab kasutajale meelde, et enne
kasutamist tuleb lugeda kasutusjuhendit.
•Selles juhendis toodud tehnikad on üksnes tootja soovitused. Lõplik vastutus
seadme patsientide ravis kasutamise eest on raviarstil.
•Enne igat kasutuskorda tuleb veenduda, et seade oleks töökorras.
•Seadet tohib kasutada ainult asjakohase väljaõppe saanud personal.
•Seadet tohib modifitseerida, täiendada ja remontida ainult volitatud
spetsialist.
•Hoidke juhend alles, et vajaduse korral saaks seda uuesti lugeda.
•Kui seadmega seoses leiab aset tõsine vahejuhtum, tuleb sellest teavitada
tootjat ning selles dokumendis nimetatud pädevat asutust.
Enne selle või muu meditsiiniseadme patsiendil kasutamist on
soovitatav lugeda läbi toote kasutusjuhend ning teha toote
kasutamine endale selgeks.