Ama Tech F-90022 User manual

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 1
Universal Head Positioner
F-90022
80028549
Version A

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 2
ENGLISH......................................................................................................................................5
中文简体......................................................................................................................................19
ČESKÝ........................................................................................................................................33
DANSK........................................................................................................................................47
NEDERLANDS ...........................................................................................................................61
FRANÇAIS..................................................................................................................................75
DEUTSCH...................................................................................................................................89
ΕΛΛΗΝΙΚΑ................................................................................................................................103
ITALIANO..................................................................................................................................117
LATVISKI..................................................................................................................................131
NORSK.....................................................................................................................................145
POLSKI.....................................................................................................................................159
PORTUGUÊS (PORTUGAL)....................................................................................................173
ESPAÑOL.................................................................................................................................187
SVENSKA.................................................................................................................................201

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 3
Product Component Overview
Orientation Label
Correct
Orientation
Incorrect
Orientation

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 4
Product Specifications
Compatible with the follwing products:
•Lift-AssistBeach Chair
•Table-Powered Beach Chair
•Maunal Lift Beach Chair
Product Spcifications:
•Device Weight: 4 lbs (1.8 kg)
•226 kg (500 lbs) maximum patient weight
Ideal For Use With the Following Procedures:
•Rotator Cuff repair
•Bankart Repair
•SLAP Lesion Repair
•Capsular Release
•Total Shoulder Replacement
•Reverse Shoulder Replacement
•Subacrimial Decompression
•Sternoclavicular Reconstruction
•Elbow Fracture Repair
Product Specifications: Size

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 5
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.
This device is a component of a higher-level medical apparatus.
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
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 6
TABLE OF CONTENTS
1. Contact Details
2. General Safety Warnings and Cautions:
Cleaning and Maintenance

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 7
1. Contact Details
For ordering information please see catalog.
customer service Information:
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.
2. 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.
[phone]
001 978 263 5401
[phone]
001 978 466 4426
International
North America

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 8
Equipment Set-Up & Use
Head Restraint
Intubation Pad
2. Intubate patient in position as
shown.
3. Fold restraint over forehead
as shown.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 9
Equipment Set-Up & Use
4. Center chin strap on patient.
Sewn Point
Sewn Point
Align patients chin
between sewn points
5. Secure first strap over patient’s
head with Velcro®.
6. Secure second strap over
patient’s head with Velcro®.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028549 Issue Date:
Version: A Page 10
Equipment Set-Up & Use
7. Tighten knobs. Be sure that the adjustment knob is on the
nonoperative side of the patient. Adjust by flipping Slide Bracket.
Slide Bracket
Height Orientation
Knob
Adjustment Knob
Typical Orientation
Smaller Patients and Table
Adaptor Orientation