Hillrom A-20750 Instrucțiuni de utilizare

Schlein Hand Positioner

Instructions for Use

Product No. A-20750

80028196

Version C

INSTRUCTIONS FOR USE         
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ENGLISH .......................................................................................................................................... 3 
中文简体 ........................................................................................................................................ 21 
中文繁體 ........................................................................................................................................ 39 
DANSK ........................................................................................................................................... 57 
FRANÇAIS ..................................................................................................................................... 74 
DEUTSCH ....................................................................................................................................... 92 
BAHASA INDONESIA .................................................................................................................. 110 
ITALIANO ..................................................................................................................................... 130 
日本語版 ...................................................................................................................................... 148 
한국어 .......................................................................................................................................... 166 
NORSK ......................................................................................................................................... 183 
ROMÂNESC ................................................................................................................................ 200 
SRPSKI .......................................................................................................................................... 219 
SLOVENSKY ................................................................................................................................. 237 
SLOVENŠČINA ............................................................................................................................ 255 
ESPAÑOL ..................................................................................................................................... 273 
SVENSKA ..................................................................................................................................... 293 
TIẾNG VIỆT .................................................................................................................................... 311 
 
 
  

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 
Schlein Hand Positioner (A-20750) 
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: ...................................................................................................... 8 
 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: ........................................... 10 
 EMC considerations: ................................................................................................ 10 
 EC authorized representative: ................................................................................ 10 
 Manufacturing Information: ................................................................................... 10 
 EU Importer Information: ......................................................................................... 10 
 Australian sponsor Information: .............................................................................. 10 
2 System .................................................................................................................................. 11 
 System components Identification: ....................................................................... 11 
 Product Code and Description: ............................................................................. 13 
 List of Accessories and Consumable Components Table: ................................. 13 
 Indication for use: ..................................................................................................... 14 
 Intended use: ............................................................................................................ 14 
3 Equipment Setup and Use: ............................................................................................... 14 
 Prior to use: ................................................................................................................ 14 
 Setup: ......................................................................................................................... 14 
 Device controls and indicators: ............................................................................. 15 
 Storage, Handling and Removal Instructions: ...................................................... 15 
3.4.1 Storage and Handling: .................................................................................... 15 

INSTRUCTIONS FOR USE         
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3.4.2 Removal Instruction: ........................................................................................ 15 
 Troubleshooting Guide: ........................................................................................... 15 
 Device Maintenance: ............................................................................................. 15 
4 Safety Precautions and General Information: ............................................................... 16 
 General Safety Warnings and Cautions: .............................................................. 16 
 Product Specifications: ........................................................................................... 16 
 Sterilization Instruction: ............................................................................................. 17 
 Cleaning and Disinfection Instruction: .................................................................. 18 
5 List of Applicable Standards: ............................................................................................ 18 
 
  

INSTRUCTIONS FOR USE

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1. 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 on-

site product demonstrations.

Copyright Notice:

Revision

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).

INSTRUCTIONS FOR USE

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International

North America

Contact Details:

For ordering information please see catalog.

Allen Customer Service Contact Information:

Safety Considerations:

1.4.1 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.

1.4.2 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.

1.4.3 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

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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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 user of the device shall first contact Hill-Rom Technical Support 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

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 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 date

of the year (3 digits) i.e. April 4th, 2019

would be represented as 19094

EN ISO 15223-1

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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 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

Indicates the need for the user to

consult the instruction 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.

INSTRUCTIONS FOR USE

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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: +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

INSTRUCTIONS FOR USE

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2 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.

Rail Attachment

Clamping Knob

Rope

Guide Groove

Cleat

Guide Plate

Finger trap

Locking knob

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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

INSTRUCTIONS FOR USE

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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.

Name of Accessory

Product Number

Carbon Minor Procedure Table

A-30410

Carbon lights Hourglass Table

A-30650

Carbon Light Rectangular Table

A-30450

30450-C Table Pad

A-30300-PAD

Pad Set for 30650

A-30502-1-B

Table Pad for 30410

A-30410

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.

Name of Consumable

Product Number

Finger Traps

Singles:

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

INSTRUCTIONS FOR USE

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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.

3 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.

INSTRUCTIONS FOR USE

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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:

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:

• 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).

INSTRUCTIONS FOR USE

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4 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.

CAUTION:

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:

Mechanical Specifications

Description

Product Dimensions

15" x 9.37" x 9.18"

(38 cm x 23.8 cm x 23.3 cm)

Material

303 Stainless Steel, 6061 T6 Aluminum, Nylon

Plastic, 18-8 Stainless Steel.

Safe Working Load on the device

16 lbs (7.25 kg)

Overall Weight of Complete Device

5 lbs (2.3 kg)

INSTRUCTIONS FOR USE

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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.

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.

Software Specifications

Description

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)

INSTRUCTIONS FOR USE

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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.

5 List of Applicable Standards:

Sl. no

Standards

Description

1

EN 62366-1

Medical devices - Part 1: Application of usability

engineering to medical devices

2

EN ISO 14971

Medical devices- Application of risk management to

medical devices.

3

EN 1041

Information supplied by the manufacturer of medical

devices

4

EN ISO 15223-1

Medical devices - Symbols to be used with medical

device labels, labelling and information to be supplied -

Part 1: General requirements

5

EN ISO 10993-1

Biological evaluation of medical devices - Part 1:

Evaluation and testing within a risk management process

6

IEC 60601-2-46

Medical electrical equipment - Part 2-46: Particular

requirements for the basic safety and essential

performance of operating tables

INSTRUCTIONS FOR USE

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Sl. no

Standards

Description

7

ISTA

International Safe Transit Association standards for

package testing

Schlein Hand Positioner

使用说明

产品编号 A-20750

80028196

Version C

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