Ama tech F-90022 User manual

Instructions for Use

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

Document Number: 80028549 Issue Date:

Version: A Page 3

Product Component Overview

Orientation Label

Correct

Orientation

Incorrect

Orientation

Instructions for Use

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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

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

Document Number: 80028549 Issue Date:

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TABLE OF CONTENTS

1. Contact Details

2. General Safety Warnings and Cautions:

Cleaning and Maintenance

Instructions for Use

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.

(978) 263-5401

001 978 263 5401

(978) 266-4426

001 978 466 4426

International

North America

Instructions for Use

Document Number: 80028549 Issue Date:

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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

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Equipment Set-Up & Use

4. Center chin strap on patient.

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

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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

Instructions for Use

Document Number: 80028549 Issue Date:

Version: A Page 11

Equipment Set-Up & Use

8. Lift and hold the patients head

while removing the intubation

pad.

Intubation Pad

9. Press button to slide and attach

Universal Head Positioner to Beach

Chair or Table Adaptor.

Press Button

10. Align top edge of Head

Restraint with top edge of

Universal Head Positioner.

Instructions for Use

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Equipment Set-Up & Use

11. Overlap Velcro® straps

across the forehead of the Head

Restraint.

Velcro® Strap

12. Lift patient with Beach Chair or

OR table using the Table Adaptor. Be

sure that the Head Positioner slides

properly along the slide rails.

Slide Rail

Raise Patient

Instructions for Use

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Equipment Set-Up & Use

13. Make any necessary adjustments to the patient’s

neck and head using the handles and adjustment

knob. Be sure to hold the handle while making

adjustments.

Adjustment

Handle

Adjustment

Knob

14. Be sure that the patient’s

ears are not bent or folded, and

eyes are not covered.

Instructions for Use

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Equipment Set-Up & Use

Finished Set-up

Instructions for Use

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Cleaning and Maintenance

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 TO CLEAN PAD

使用说明

Document Number: 80028549 Issue Date:

Version: A 页码 16

Universal Head Positioner

F-90022

80028549

Version A

使用说明

Document Number: 80028549 Issue Date:

Version: A 页码 17

产品组件概述

方向标签

正确的方向

不正确的方向

滑动支架

滑轨

调节旋钮

手柄

下巴绑带

方向标签

使用说明

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产品规格

与以下产品兼容：

•Lift-AssistBeach Chair

•Table-Powered Beach Chair

•Manual Lift Beach Chair

产品规格：

•设备重量：1.8 kg (4 lbs)

•最大患者体重 226 kg (500 lbs)

适用于以下手术：

•肩袖修复术

•Bankart 修复术

•SLAP 病变修复

•肩关节囊释放术

•全肩关节置换术

•逆向肩关节置换术

•肩峰下减压术

•胸锁骨重建术

•肘部骨折修复术

产品规格：尺寸

203 mm

(8”)

254 mm

(10”)

使用说明

Document Number: 80028549 Issue Date:

Version: A 页码 19

重要通知

•将设备用于患者之前，请先阅读并了解本手册中以及设备上的所有警告。

•符号用于提醒用户注意有关使用本设备的一些重要操作规程或安全说明。

•标签上的符号旨在提示使用中何时应参考 IFU。

•本手册中详细介绍的技术仅作为制造商的建议。使用本设备进行患者治疗的最终责

任仍由主治医师承担。

•每次使用之前，应检查设备功能。

•本设备只应由接受过培训的人员操作。

•任何修改、升级或维修都必须由经过授权的专业人员执行。

•请务必保存好本手册，以备日后参考。

•如果出现与设备相关的严重事故，应立即报告制造商和本文档所列的主管机构。

本设备为高级医疗设备的一个组件。将本设备或其他类型的医疗设备用于患

者前，建议阅读

使用说明

并熟悉产品。

使用说明

Document Number: 80028549 Issue Date:

Version: A 页码 20

1. 详细联系方式

2. 一般安全警告和警示：

清洁和维护

Ama Tech F-90022 User manual

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