Hillrom A-20750 Schlein Hand Positioner Instructions

Schlein Hand Positioner
Instructions for Use
Product No. A-20750

80028196 Version C

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.

General Information:

Allen Medical Systems, Inc. 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.
Allen products are backed by responsive and reliable service and complimentary onsite product demonstrations.

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 at Allenmedical.com/pages/terms- conditions.
Products may be covered by one or more patents. Please consult listing at Hill-rom.com/patents for any patent(s).

Contact Details:

For ordering information please see catalog.
Allen Customer Service Contact Information:

Safety Considerations:

Safety hazard symbol notice:

DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.

Note: Autoclave steam sterilization of the Hand Positioner may cause the polycarbonate plates to change in appearance and/or texture. These changes, e.g. cloudiness, crazing, etc. will not affect the functionality of this product.

Equipment misuse notice:

Do not use the product if package is damaged or unintentionally opened before use. All modifications, upgrades, or repairs must be performed by an authorized specialist.

Notice to users and/or patients:

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and 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

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 user of the device shall first contact Hill-Rom Technical Support for guidance on safe disposal protocols.

Operating the system:

Applicable Symbols:

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 manufacturer’s lot code using the Julian Date yyddd, where yy indicates the last two digits of the year and ddd (2 digests) indicates the ate of the year (3 digits) i.e. April 4 th , 2019 would be represented as 19094| EN ISO 15223-1
| Indicates the date when the medical device was manufactured| 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 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 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 Medical Device complies to REGULATION (EU) 2017/745| MDR 2017/745
| Indicates a Warning| IEC 60601-1
| Indicates the need for the user toconsult the instruction 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.

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).

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: +33 (0)2 97 50 92 12

Manufacturing Information:

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

EU Importer Information:

TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss Straße 7-9 07318 Saalfeld/Saale Germany

Australian sponsor Information:

Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083

System

System components Identification:

Rail Attachment: Rail attachment is used as a bridge between OR table and simple clamp.
Guide plate: Guide plate is made up of acrylic material and used to guide the finger rope to provide traction.
Cleats: Cleats are attached with guide plate and used to secure the finger trap ropes to hold tension.
Rope: Rope is attached to the finger trap which is used to fix the finger traps to provide a proper traction to the patient fingers.

Finger traps (Consumable parts):
a. Finger Traps are latex free and made from a double layer woven fabric which distributes gripping forces over the entire finger, eliminating painful ischemic pressure points. Finger trap is a sterile, disposable device intended to grip one or two fingers to support the arm while in traction.
b. Finger Traps are intended for the distraction of the arm and wrist during arthroscopic surgery.
c. The finger trap may also be used for finger traction. Finger Traps may be used in conjunction with the Equalizer, Tower Extremity System and Weightless Shoulder Suspension System.
d. Finger Traps are available in five color coded sizes and in single or double configuration. Finger Traps are double packaged; the contents are sterilized. The inner package may be placed into the sterile field and then opened for use.

CAUTION: Do not re-sterilize.
CAUTION: Inspect sterile package before opening. If seal is broken, contents may not be sterile.

Finger traps Directions for Use:

• When using the finger trap system, it is highly recommended to use the double finger trap system. This eliminates putting all the strain on one finger.
• Ensure that the finger traps completely cover the entire length of fingers.
• Confirm that the finger traps are not slipping by gently pulling on the loop before putting in traction.
• If the finger trap fits loosely over the patient’s finger, try a different size to ensure a snug fit for maximum gripping force.
• The amount of traction will vary depending on the patient and type of surgery. Thus, traction limits should be specified by the physician.

Disposable Finger traps

Product Code and Description:

A-20750 – Schlein Hand Positioner

List of Accessories and Consumable Components Table:

The following list are accessories and components that may be used with this device.

A-30522-2 Single, Large
A-30522-4 Single, Medium
A-30522-5 Single, Small
A-30522-8 Single, Extra Large
A-30522-9 Single Paediatric Trap
Doubles:
A-30522-1 Double, Large
A-30522-3 Double, Medium
A-30522-6 Double, Small
A-30522-7 Double, Extra Large

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 Schlein Hand Positioner is used in a variety of surgical procedures including, but not limited to arthroscopic or open Orthopedic surgery. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

Intended use:

The Schlein Hand Positioner is designed to position, support and/or distract the patient’s hand, wrist, forearm and arm in a variety of surgical procedures including, but not limited to arthroscopic or open Orthopedic surgery. These devices are intended to be used by healthcare professionals within the Operating Room setting.

Equipment 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:

1. Install the Schlein Rail attachment assembly prior to proceeding. Ensure that the knobs attaching the Rail Assembly to the table and rail surface are secure and there are no failures or indications of damage to the knobs.
2. Check the rail surface for areas of damage or impact which could cause interference with the Schlein Positioner. Discontinue use if the Rail Assembly is damaged and will not allow the Positioner to be loaded.
3. Loosen the locking knob on the mounted Rail Assembly, allowing the Schlein Positioner to slide on to the Rail Assembly.
4. Tighten the locking knob on the Rail Assembly once the Schlein Positioner is in the desired location. Make sure it is stable and secure before proceeding.
5. Place the finger traps on the patient’s fingers and insert the finger trap ropes through the holes in the Positioner. Hole selection will be determined by factors such as the number of finger traps being used and the finger position desired by the surgeon.
6. For procedures using the vertical hand position, it is recommended that the top and middle finger trap finger trap ropes be passed through the top and middle holes in the vertical row of holes. These two ropes must be inserted into the Hand Positioner cleats with the closed tops. The center rope goes into the center cleat.
7. To use the cleat, pull the finger trap rope through the cleat and down until the cleat catches the rope. Ropes may be shortened for convenience.
8. For procedures using weights, attach the weights to the finger trap ropes and position the ropes in the Hand Positioner guide grooves located between the cleats on the distal end of the positioner. Adjust weights and finger positions as needed.

Device controls and indicators:

Controls and indicators of this device are described within the Setup instructions.

Storage, Handling and Removal Instructions:

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.

Removal Instruction:

• Lift the finger trap ropes out of the cleat grooves and pass them back through the holes in the Schlein Hand Positioner.
• Loosen the locking knob on the mounted Rail Assembly, allowing the Schlein Positioner to slide out of the Rail Assembly.
• Loosen the knobs attaching the Rail Assembly to the table and rail surface to remove the Rail Assembly.
• Always follow the cleaning and sterilization steps for this product.

Troubleshooting Guide:

This device does not have a troubleshooting guide. For technical support user of the device shall first contact Hill-Rom Technical Support.

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 Allen Medical Systems, Inc. if you need to repair or replace the device contact us using the information from the contact details section (1.3).

Safety 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. Product will be damaged, if it is cleaned with bleach.
e. Prior to using this or any other type of medical apparatus with a patient, it is highly
recommended that you read the Instructions for Use and familiarize yourself with the product.
f. Do not use if product shows visible damage.
g. Read and understand all warnings in this manual and on the device itself prior to use for patient.
h. Device function should be checked prior to each usage.
i. This device should only be operated by medically trained personnel.

WARNING:

a. Do not exceed safe working load shown in the product specification table.
b. Do not use product if the sterile package is damaged or unintentionally opened before use.
c. Do not reuse the Consumables such as Allen Finger Traps.
d. Do not re-sterilize the Consumables such as Allen Finger Traps.

Product Specifications:

Steel.
Safe Working Load on the device| 16 lbs (7.25 kg)
Overall Weight of Complete Device| 5 lbs (2.3 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| Description
Not Applicable.| Not Applicable.
Software Specifications| Description
Not Applicable.| Not Applicable.
Compatibility Specifications| Description
The Schlein Hand Positioner is compatible with:| • Carbon LightsTM Rectangular Table (A-30450-C)
• Carbon LightsTM Hourglass Table (A-30650-C)
• Carbon LightsTM Minor Procedure Table (A-30410-C) B4:C18

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

Sterilization Instruction:

Following are the parts which will undergo sterilization process:

• Allen® Schlein Hand Positioner: Autoclave Sterilization
  Note: Device will be supplied as NON-STERILE, but user responsibility to sterilize the device before use.

Full Cycle Instructions:
Cycle Type: Pre-vacuum Sterilization
Temperature: 132.2°C -1°C +3°C
Sterilization Time: 4.0 minutes
Minimum Dry Time: 30 minutes
Packaging: Two (2) layers non-woven CSR wrap
Cool-Down Time: 60 Minutes

Note: Autoclave steam sterilization of the Hand Positioner may cause the polycarbonate plates to change in appearance and/or texture. These changes, e.g. cloudiness, crazing etc. will not affect the functionality of this product.

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.

List of Applicable Standards:

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

Hillrom Technical Support
hillrom.com/en-us/about-us/locations/
Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc.

References

• allenmedical.com - allenmedical Resources and Information.
• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom
• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom

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