Hillrom A-70715 User manual

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 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
©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 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
©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 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
©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 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.
[phone]
[phone] ext.4286
[phone]
[phone]

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 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
©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 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
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
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
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
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
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A 页码 10
目录
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

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A 页码 11
国际
北美洲
1. 详细联系方式
有关订购信息，请参阅目录。
Allen 客户服务联系信息：
2. 一般安全警告和警示：
警告：
a. 如果产品出现明显损坏，请勿使用。
b. 使用该设备前，请阅读设备安装和使用说明。 应用于患者前，请让自己熟悉产品。
c. 为避免患者和/或用户受伤和/或设备损坏，请在使用前检查设备和手术台侧轨道是否存
在可能的损坏或磨损。 如发现设备明显损坏、部件缺失或无法正常工作，请勿使用。
d. 为避免患者和/或用户受伤和/或设备损坏，请确保设备连接夹完全触碰手术台侧轨道并
牢固就位。 测试锁定机械装置，确保升高或按下时不会移动。
小心：
切勿超过设备安全工作负载。
[phone]
[phone] 转4286
[phone]
[phone]

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A 页码 12
3. 设备设置和使用
本产品应与 Allen C-Flex Polar Head Positioning System 配合使用。
有关详细说明，请参阅 Allen C-Flex 用户指南。
锥形接头
支撑床垫
用于配合：
下巴支撑架
ALLEN COMFORT MASK
A-70302
（单独出售）
配合 Allen Comfort Mask 使用。
不适用于刚性固定。

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A 页码 13
4. 清洁和维护
警告：
•请勿使用漂白剂或含漂白剂的产品清洁设备。可能会导致人员受伤或设备损坏。
•每次使用后，使用酒精拭巾清洁设备。
•请勿将设备放入水中。否则可能会导致设备损坏。
•请使用布和季铵盐类消毒/清洁液清洁和消毒设备。
•请阅读并遵循制造商建议进行基本消毒。
•阅读并遵循清洁用品说明。在液体可能进入机械装置的区域，请小心操作。
•请使用一块干净的干布擦拭设备。
•在存储或再次使用设备之前，请确认其干燥。
•该设备并非无菌。可能导致设备损坏。

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Side 14
C-Flex Prone Face Mask Head Module
A-70715
80028551
Version A

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Side 15
VIGTIGE BEMÆRKNINGER
•Læs og forstå alle advarsler i denne manual og på selve enheden, før
denne anvendes til en patient.
•Symbolet er beregnet til at advare brugeren om vigtige procedurer eller
sikkerhedsanvisninger vedr. brugen af denne enhed.
Symbolet på mærkaterne er beregnet til at vise, når
brugsanvisningen skal anvendes.
•De teknikker, der beskrives i manualen, er udelukkende producentens
anbefalinger. Det endelige ansvar for patientplejen med hensyn til
enheden ligger hos den behandlende læge.
•Før hver anvendelse skal det kontrolleres, at enheden fungerer.
•Enheden skal altid betjenes af uddannet personale.
•Alle ændringer, opgraderinger og reparationer skal udføres af en
autoriseret specialist.
•Sørg for, at denne manual er til rådighed til fremtidig reference.
•Enhver alvorlig hændelse, der er opstået i forhold til enheden, skal
meddeles til producenten og den ansvarlige myndighed, der er angivet i
dette dokument.
Denne enhed er en komponent i et medicinsk apparat på et højere
niveau. Inden brug af dette og andre former for medicinsk udstyr
med en patient anbefales det, at man læser brugsanvisningen og
sætter sig ind i produktet.

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Side 16
INDHOLDSFORTEGNELSE
1. Kontaktoplysninger
2. Generelle sikkerhedsadvarsler og forholdsregler:
3. Opsætning og brug af udstyret
4. Rengøring og vedligeholdelse

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Side 17
International
North America
1. Kontaktoplysninger
Se venligst kataloget vedrørende bestillingsoplysninger.
Allen kundeservice, kontaktoplysninger:
2. Generelle sikkerhedsadvarsler og forholdsregler:
ADVARSEL:
a. Produktet må ikke anvendes, hvis det viser tegn på beskadigelse.
b. Før brug af enheden bedes du læse anvisningerne til opsætning og brug af
udstyret. Gør dig bekendt med produktet, før du anvender det på en patient.
c. For at forhindre skader på patienten og/eller brugeren og/eller beskadigelse af
udstyr skal enheden og skinnerne i siden på det kirurgiske leje undersøges for
mulig beskadigelse eller slitage før brug. Enheden må ikke anvendes, hvis der er
synlige skader, der mangler dele eller hvis enheden ikke fungerer som forventet.
d. For at forhindre skader på patient og/eller bruger og/eller beskadigelse af udstyr
skal det kontrolleres, at enhedens fastgørelsesklamper er komplet i berøring med
skinnerne i siden på lejet og sidder korrekt. Test låsemekanismen for at sikre, at
lejet ikke bevæger sig, når det hæves eller skubbes.
FORSIGTIG:
Overskrid ikke enhedens sikre arbejdsbelastning
[phone]
[phone] ext.4286
[phone]
[phone]

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Side 18
3. Opsætning og brug af udstyret
Dette produkt er beregnet til brug med Allen C-Flex Polar Head Positioning System.
Se brugervejledningen til Allen C-Flex for at få yderligere vejledning.
KEGLEADAPTER
STØTTEOVERFLADE
TIL BRUG MED:
HAGESTØTTE
ALLEN COMFORT MASK A-70302
(SÆLGES SEPARAT)
Bruges sammen med Allen Comfort Mask.
Ikke beregnet til fast fiksering.

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Side 19
4. Rengøring og vedligeholdelse
ADVARSEL:
•Brug ikke blegemiddel eller produkter, der indeholder blegemiddel, til at rengøre
enheden. Der kan ske personskade og/eller materiel skade.
•Efter hver brug skal du rengøre enheden med alkoholbaserede vådservietter.
•Undlad at nedsænke enheden i vand. Udstyret kan blive beskadiget.
•Brug en klud og et desinfektions-/rengøringsmiddel med kvaternær ammonium til
rengøring og desinfektion af enheden.
•Læs og følg producentens anbefalinger vedrørende lavniveaudesinfektion.
•Læs og følg anvisningerne for rengøringsproduktet. Vær forsigtig i områder, hvor der
kan trænge væske ind i mekanismen.
•Aftør enheden med en ren, tør klud.
•Kontroller, at enheden er tør, før du opmagasinerer den eller bruger den igen.
•Denne enhed er ikke beregnet til at blive steriliseret. Dette kan forårsage materiel
skade.

Gebruiksaanwijzing
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028551 Issue Date: 20 MAY 2020
Version: A Pagina 20
C-Flex Prone Face Mask Head Module
A-70715
80028551
Version A