Hillrom A-70715 Manuale utente

Instructions for Use

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A Page 1

C-Flex Prone Face Mask Head Module

A-70715

80028551

Version A

 
Instructions for Use 
 
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B 
Document Number: 80028551 Issue Date: 20 MAY 2020 
Version: A Page 2 
 
ENGLISH......................................................................................................................................3 
中文简体........................................................................................................................................9 
DANSK........................................................................................................................................15 
NEDERLANDS ...........................................................................................................................21 
SUOMI........................................................................................................................................27 
FRANÇAIS..................................................................................................................................33 
DEUTSCH...................................................................................................................................39 
ΕΛΛΗΝΙΚΑ..................................................................................................................................45 
ITALIANO....................................................................................................................................51 
LATVISKI....................................................................................................................................57 
NORSK.......................................................................................................................................63 
POLSKI.......................................................................................................................................69 
PORTUGUÊS.............................................................................................................................75 
ROMÂNESC...............................................................................................................................81 
SRPSKI.......................................................................................................................................87 
SLOVENSKY..............................................................................................................................93 
SLOVENŠČINA ..........................................................................................................................99 
ESPAÑOL.................................................................................................................................105 
SVENSKA.................................................................................................................................111 
 

Instructions for Use

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A Page 3

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: 80028551 Issue Date: 20 MAY 2020

Version: A Page 4

TABLE OF CONTENTS

1. Contact Details

2. General Safety Warnings and Cautions:

3. Equipment set up and use

4. Cleaning and Maintenance

Instructions for Use

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A Page 5

International

North America

1. Contact Details

For ordering information please see catalog.

Allen Customer Service Contact Information:

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.

d. To prevent patient and/or user injury and/or equipment damage, verify the

device attaching clamps completely touch the table-side rails and are firmly in

place. Test the locking mechanism to ensure no movement when elevated or

pushed.

CAUTION:

Do not exceed the device safe working load.

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

Instructions for Use

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A Page 6

3. Equipment set up and use

This product is meant for use with the Allen C-Flex Polar Head Positioning System.

Refer to the Allen C-Flex User Guide for further instructions.

CONE ADAPTOR

SUPPORT SURFACE

FOR USE WITH:

CHIN SUPPORT

ALLEN COMFORT MASK

A-70302

(SOLD SEPARATELY)

Use with the Allen Comfort Mask.

Not intended for rigid fixation.

Instructions for Use

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A Page 7

4. 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.

•This device is not intended to be sterilized. Equipment damage may occur.

使用说明

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A 页码 8

C-Flex Prone Face Mask Head Module

A-70715

80028551

Version A

使用说明

Document Number: 80028551 Issue Date: 20 MAY 2020

Version: A 页码 9

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: 80028551 Issue Date: 20 MAY 2020

Version: A 页码 10

1. 详细联系方式

2. 一般安全警告和警示：

3. 设备设置和使用

4. 清洁和维护

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