Ama Tech I-CLKSMNS User manual

Siemens Cysto Lift Knee Crutch
Instructions for Use
Product No. I-CLKSMNS
80028306
Version B

INSTRUCTIONS FOR USE
Document Number: 80028306 Page 2 Issue Date: 19 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ......................................................................................................................................... 3
FRANÇAIS .................................................................................................................................... 19
DEUTSCH ...................................................................................................................................... 36
ITALIANO ..................................................................................................................................... 53
ROMÂNESC ................................................................................................................................. 69
SRPSKI .......................................................................................................................................... 86
SLOVENSKY ............................................................................................................................... 102
SLOVENŠČINA .......................................................................................................................... 119
ESPAÑOL ................................................................................................................................... 135
SVENSKA .................................................................................................................................... 152

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
Cysto Knee Crutch (I-CLKSMNS)
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: ................................................................................................................ 11
3Equipment Setup and Use:............................................................................................... 12
Prior to use:.................................................................................................................. 12
Setup:........................................................................................................................... 12
Device controls and indicators:............................................................................... 13
Storage, Handling and Removal Instructions:........................................................ 14
3.4.1 Storage and Handling: ................................................................................... 14
3.4.2 Removal Instruction:........................................................................................ 14

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Troubleshooting Guide:............................................................................................. 14
Device Maintenance: ............................................................................................... 14
4Safety Precautions and General Information:............................................................... 14
General Safety Warnings and Cautions: ................................................................ 14
Product Specifications: ............................................................................................. 15
Sterilization Instruction: .............................................................................................. 16
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
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).

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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.

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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]

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Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
[phone] (INTERNATIONAL)
2System
System components Identification:
Product Code and Description:
I-CLKSMNS - Siemens Cysto Lift Knee Crutch
Boot System
Gas Spring
Knob 1
Knob 2
Release Handle

INSTRUCTIONS FOR USE
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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
Nissen Thigh Straps
F-NTS
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 Knee Crutch is used in a variety of short surgical procedures including, but not
limited to cystoscopy surgery. These devices are capable of being used with a
broad patient population as determined appropriate by the caregiver or
institution.
Intended use:
The Knee Crutch is designed to position and support the patient’s lower leg and
upper leg in a variety of short surgical procedures including, but not limited to
cystoscopy 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, user
or patient harm from misuse, device damage, function or mechanical hazards
cannot be completely excluded.
Name of Consumable
Product Number
Urology/ Gyn Fluid Collection System Drapes
F-UC31, F-UC32
Egg Crate foam
F-10150

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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:
a. Place patient on table in a comfortable position.
b. Mount the Cysto-Lift Knee Crutch into the supplied clamps. Locate these
clamps adjacent to the patient’s hip joint.
c. Mount the Knee Crutch into the clamps. Locate these clamps adjacent to the
patient’s hip joint.
d. Place Knee Crutch into the desired amount of abduction and then lock clamps
securely into place, by tightening knob 1.
e. Once the Knee Crutches are located approximately to the desired position of
the patient’s calves, tighten knob 2.
f. Ensure that the Knee Crutch pads are in place and arranged properly. The Knee
Crutch straps should be out of the way.

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g. If the patient is anesthetized, obtain adequate help to place both legs into the
Knee Crutch boots simultaneously; this significantly reduces risk of patient injury.
h. Adjust the boot position by placing a supporting hand near the mount
underneath the boot. Loosen knob 2. Align the toe, knee, hip and opposing
shoulder. Retighten knob 2.
i. Ensure that all clamps are securely locked.
j. Secure the Knee Crutch straps. Avoid tightening these straps against the leg.
You should be able to slip your finger between. the leg and strap at the tightest
point. If it is necessary to restrain the leg more securely, adequate padding
should be applied between the straps and the leg.
k. Check to ensure that no undue pressure is being applied to the leg. Do not
permit anyone or anything to lean on the patient’s leg at any time.
IMPORTANT NOTE:
Whenever practical, patients should be placed in the Knee Crutches prior to
anesthesia. An alert patient can communicate normal range of motion limitations
and, to some extent, such patients opposing muscles will guard against abnormal
joint movement and stretching. Once the patient’s pain and pressure receptors
have been neutralized by anesthesia, the patient is much more vulnerable to over
stretching of muscles and ligaments as well as pressure related injury. Knee
Crutches are not recommended for extended procedures where pressure on the
Popliteal Fossa could be of concern.
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. Remove the Cysto Knee Crutch straps over the foot pad.
b. Gently remove patient’s legs from Stirrups.
c. loosen the Clamp handle and remove the Knee crutch from it.
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.

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e. Additional positioning devices should be used when using the stirrup in
Trendelenburg or reverse Trendelenburg.
f. 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.
g. The patient's toes may extend beyond the end of the stirrup boot.
h. The product must be used with compatible clamps.
i. Check for patient contact pressure points and consult the physician before use.
j. Warn the user against using non-approved padding.
k. To secure the patient's legs in the boots prior to making adjustments.
l. The device shall include a 2year warranty for the stirrup.
m. The boot pad shall include a 1year warranty for the stirrup padding.
CAUTION:
a. Do not raise the 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 the warranty.
c. Do not clean stirrup by immersing it in liquid or using high-pressure spray. Such
action may damage product.
d. Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
26 ¼” X 13 3/8” X 15 5/8”(66.6cm x 34cm x
39.5cm)
Material
Stainless Steel, Alloy Steel, Aluminum,
Engineering Polymers, Bronze
Safe Working Load on the device
350 lbs (159 kg)
Overall Weight of Complete Device
16.5 lbs (7.4 kg) Each
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC
Storage Relative humidity range
15% to 85%
Operating temperature
This device is intended to be used in a
controlled Operating Room environment.
Operating Relative humidity range
Electrical Specifications
Description
Not Applicable.
Not Applicable.

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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
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Cysto Lift Knee Crutch is
compatible with:
a. Clip-On TM Blade Clam
F-40040(US), F-40041(EU),
F-40042(UK), F-40043(JP)
b. Rail Clamps: F-RC2, F-RC29X32MM,
F-RC2XD(Denyer), F-RC2XUK (UK/Euro)
c. 3 Way Adjustment Clamp:
F-TCP2, F-TCP2(EU)

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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

Siemens Cysto Lift Knee Crutch
Instructions d'utilisation
Nº de produit I-CLKSMNS
80028306
Version B

INSTRUCTIONS D'UTILISATION
Document Number: 80028306 Page 19 Issue Date: 19 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
INFORMATIONS IMPORTANTES
•Assurez-vous de 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.
•Conservez 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.

INSTRUCTIONS D'UTILISATION
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Table des matières
Cysto Knee Crutch (I-CLKSMNS)
1Informations générales ..................................................................................................... 22
Avis de droits d'auteur :............................................................................................. 22
Marques de commerce :.......................................................................................... 22
Coordonnées :............................................................................................................ 23
Consignes de sécurité :............................................................................................. 23
1.4.1 Avis relatif au symbole de danger pour la sécurité :.................................. 23
1.4.2 Avis de mauvaise utilisation de l'équipement :........................................... 23
1.4.3 Avis aux utilisateurs et/ou aux patients : ...................................................... 23
1.4.4 Mise au rebut en toute sécurité : .................................................................. 23
Utilisation du système :............................................................................................... 24
1.5.1 Symboles applicables :................................................................................... 24
1.5.2 Population de patients et utilisateurs prévus :............................................. 25
1.5.3 Conformité au règlement relatif aux dispositifs médicaux :...................... 25
Considérations relatives à la CEM :......................................................................... 25
Représentant autorisé dans la CE : ......................................................................... 25
Informations de fabrication :.................................................................................... 26
2Système............................................................................................................................... 26
Identification des composants du système : ......................................................... 26
Code produit et description :................................................................................... 26
Tableau de la liste des accessoires et des consommables :............................... 27
Indication d'utilisation :.............................................................................................. 27
Usage prévu :.............................................................................................................. 27
Risque résiduel :.......................................................................................................... 28
3Mise en place et utilisation du dispositif :....................................................................... 28
Avant l'emploi :........................................................................................................... 28
Mise en place :........................................................................................................... 28
Commandes et indicateurs du dispositif :.............................................................. 29
Instructions de stockage, de manipulation et de retrait :.................................... 30
3.4.1 Stockage et manipulation : ........................................................................... 30
3.4.2 Instructions de retrait :..................................................................................... 30