Hillrom A-20750 取扱説明書

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取扱説明書
Schlein Hand Positioner
Instructions for Use
Product No. A-20750
80028196
Version C
INSTRUCTIONS FOR USE
Document Number: 80028196 Page 2 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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
TING VIT .................................................................................................................................... 311
INSTRUCTIONS FOR USE
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Version C Ref Blank Template: 80025117 Ver. F
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
© 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).
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
Reference
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
21 CFR 830
MDR 2017/745
EN ISO 15223-1
INSTRUCTIONS FOR USE
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EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
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
INSTRUCTIONS FOR USE
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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
-29 C to +60 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)
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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Hillrom A-20750 取扱説明書

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取扱説明書