JUNIOR POWER -LIFT STIRRUPS Instructions for Use ver A

INSTRUCTIONS FOR USE 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

Document Number: 80028206 Version: A

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INSTRUCTIONS FOR USE IMPORTANT NOTICES 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.

•

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.

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INSTRUCTIONS FOR USE

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 Document Number: 80028206 Version: A

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INSTRUCTIONS FOR USE 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 4.4 Cleaning and Disinfection Instruction: ...17 5. List of Applicable Standards: ...18

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INSTRUCTIONS FOR USE 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/termsconditions. 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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INSTRUCTIONS FOR USE 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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INSTRUCTIONS FOR USE 1.5

Operating the system: 1.5.1

Applicable Symbols:

Symbol used

Description 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

Document Number: 80028206 Version: A

Reference

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INSTRUCTIONS FOR USE

1.5.2

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

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 CEmarked 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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INSTRUCTIONS FOR USE 1.7

EC authorized representative: HILL-ROM SAS B.P. 14 - Z.I. DU TALHOUET 56330 PLUVIGNER FRANCE TEL: +33 (0)2 97 50 92 12

1.8

Manufacturing Information: ALLEN MEDICAL SYSTEMS, INC. 100 DISCOVERY WAY ACTON, MA 01720 USA 800-433-5774 (NORTH AMERICA) +1 978-266-4200 (INTERNATIONAL)

2. System 2.1

System components Identification:

Clamshell Pad Release Handle Boot

Boot Locking Mechanism

Blade Mount

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INSTRUCTIONS FOR USE 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

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)

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.

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INSTRUCTIONS FOR USE 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. Blade

Rail Clamp

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.

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INSTRUCTIONS FOR USE 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. Document Number: 80028206 Version: A

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INSTRUCTIONS FOR USE

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 a.

Removal Instruction:

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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INSTRUCTIONS FOR USE

b.

3.5

recommends the lowering and staging process take two full minutes. Gently remove patient’s legs from Stirrups. Stirrups should be in horizontal position for removal from Rail Clamp slot. 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.

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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INSTRUCTIONS FOR USE i. j. k. l.

The patient's toes may extend beyond the end of the stirrup boot. The product must be used with compatible clamps. Check for patient contact pressure points and consult the physician before use. 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

-29ᵒ C to +60ᵒ C

Storage Relative humidity range

15% to 85%

Operating temperature

This device is intended to be used in a controlled Operating Room environment.

Operating Relative humidity range Electrical Specifications Not Applicable. Software Specifications Document Number: 80028206 Version: A

Description Not Applicable. Description

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INSTRUCTIONS FOR USE Not Applicable.

Not Applicable.

Compatibility Specifications

Description a. Clip-On™ Blade Clamp F-40040 (US), F-40041 (EU), F-40042 (UK), F-40043 (Japan)

The Junior Stirrups are compatible with:

b. Rail Clamp F-RC2 (US), F-RC2XUK (EU/UK), F-RC2XD (Denyer), F-RC29X32MM (Japan), F-RCS (Swiss)

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

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INSTRUCTIONS FOR USE 5. List of Applicable Standards: Sl. no

Standards

1.

EN 62366-1

2.

EN ISO 14971

3.

EN 1041

4.

EN ISO 15223-1

5.

EN ISO 10993-1

6.

IEC 60601-2-46

7.

ISTA

Document Number: 80028206 Version: A

Description Medical devices - Part 1: Application of usability engineering to medical devices Medical devices- Application of risk management to medical devices. Information supplied by the manufacturer of medical devices Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables International Safe Transit Association standards for package testing

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BRUKSANVISNING 5. Oversikt over anvendbare standarder: Serienr.

Standarder

1.

EN 62366-1

2.

EN ISO 14971

3.

EN 1041-1

4.

EN ISO 15223-1

5.

EN ISO 10993-1

6.

IEC 60601-2-46

7.

ISTA

Document Number: 80028206 Version: A

Beskrivelse Medical devices - Part 1: Application of usability engineering to medical devices Medical devices- Application of risk management to medical devices. Information supplied by the manufacturer of medical devices Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables International Safe Transit Association standards for package testing

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