Ama Tech F-90016 User manual

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 1
Beach Chair Standard Headrest
F-90016
80028542
Version A

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 2
ENGLISH........................................................................................................................................ 3
中文简体...................................................................................................................................... 10
DANSK ........................................................................................................................................18
NEDERLANDS .............................................................................................................................25
SUOMI......................................................................................................................................... 33
FRANÇAIS...................................................................................................................................40
DEUTSCH ....................................................................................................................................48
ΕΛΛΗΝΙΚΑ ..................................................................................................................................56
ITALIANO ....................................................................................................................................64
日本語版...................................................................................................................................... 71
한국어 .........................................................................................................................................78
NORSK ........................................................................................................................................86
POLSKI ........................................................................................................................................93
PORTUGUÊS (PORTUGAL) ....................................................................................................... 100
ROMÂNESC .............................................................................................................................108
РУССКИЙ ................................................................................................................................116
ESPAÑOL ..................................................................................................................................124
SVENSKA...................................................................................................................................132
TÜRK..........................................................................................................................................139

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 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: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 4
TABLE OF CONTENTS
1. Contact Details
2. General Safety Warnings and Cautions:
3. Equipment set up and use
3.1. Product Specifications
3.2. Set up and use
3.3. Equipment Removal
4. Cleaning and Maintenance

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 5
1. Contact Details
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.
CAUTION: Do not exceed the device safe working load
3. Equipment set up and use
3.1. Product Specifications
Compatible with the following products:
•Lift-Assist Beach Chair
•Table-Powered Beach Chair
•Manual Lift Beach Chair
•OR Table Adaptor (attaches to any OR table)
Product Specifications:
•400 lbs (181 kg) maximum patient weight
Ideal For Use With The Following Procedures:
•Rotator Cuff Repair
•Bankart Repair
•SLAP Lesion Repair

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 6
•Capsular Release
•Total Shoulder Replacement
•Reverse Shoulder Replacement
•Subacromial Decompression
•Sternoclavicular Reconstruction
•Elbow Fracture Repair
3.2. Set up and use
a. Remove the Headrest by depressing the button and sliding the Headrest off the
support tubes (as shown). Retract the Headrest support tubes by depressing the two
buttons on the underside of the Headrest (as shown) and push in on the support tube
assembly until it stops.
b. If the surgical table has a perineal cutout, rotate the body section pad around so the
perineal cutout is facing the patient's feet and the back section of the pad is
completely covering the perineal cut out of the table. Ensure that the pad is butted
up against the beach chair pad.
c. Transfer the patient using standard hospital practice by placing patient’s hips where
the beach chair pad meets with the surgical table pad.

Instructions for Use
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Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 7
d. Intubate the patient and while holding patient’s head, pull out Headrest support
tube Assembly until you hear a “click”. Re-install the Headrest by depressing the
button and slide the Headrest Assembly onto the support tubes.
e. Loosen the Velcro straps and place patient’s head in the Headrest. Secure the
patient’s head by cinching forehead Velcro strap and then securing it back on top
of itself.
f. Perform the same function for the Velcro strap over the patient's head, ensuring that
it is not too tight. Ensure the forehead pad is properly positioned across the center of
the patient's forehead to provide added comfort. Also, care should be taken to
ensure the Headrest pad does not compress the patient’s ears.
•NOTE: In the event of a short patient, less than 1.5 m (5 feet) tall, where the headrest
does not fit securely over the patient's head, the Head Rest Assembly can be
removed from the Support Tubes (as described previously) and replaced upside
down. You can rotate the head assembly about the Headrest Positioning Post by
loosening the clamp and repositioning the Headrest Assembly. This will enable you to
lower the Headrest Assembly by approximately 15.25 cm (6 inches).
•NOTE: Remove and rotate the Headrest Assembly back to the normal orientation
once the procedure is complete to ensure that it will fit your normal to tall patients.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Page 8
3.3. Equipment Removal
To remove Standard Head Positioner: Undo Velcro® straps and detach Standard
Head Positioner from slide rails. Replace with Intubation Pad.
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.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS TO CLEAN PAD
Forehead Pad

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A 页码 9
Beach Chair Standard Headrest
F-90016
80028542
Version A

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A 页码 10
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: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A 页码 11
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
3.1. 产品规格
3.2. 设置和使用
3.3. 设备拆卸
4. 清洁和维护

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A 页码 12
1. 详细联系方式
有关投诉或订购信息，请与您的供应商联系并参考目录。任何修改、升级或维修都必须由
经过授权的专业人员执行。
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。
小心：切勿超过设备安全工作负载。
3. 设备设置和使用
3.1. 产品规格
与以下产品兼容：
•Lift-Assist Beach Chair
•Table-Powered Beach Chair
•Manual Lift Beach Chair
•OR Table Adaptor（可安装在任何手术台上）
产品规格：
•最大患者体重 181 kg (400 lbs)
适用于以下手术：

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
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•肩袖修复术
•肩关节脱臼修复术
•上肩盂唇剥离修复术
•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
3.2. 设置和使用
a. 按下按钮，将头枕从支撑管上滑下，取下头枕（如图所示）。按下头枕底侧的两个按钮，将头
枕支撑管缩回（如图所示），然后向内推支撑管组件，直到其停住。
头枕释放
按钮
支撑管缩
回按钮

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
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b. 如果手术台有会阴开口，请将身体部分的垫子旋转，使会阴开口面对患者双脚，垫子的后部完
全覆盖手术台的会阴开口。确保该垫子与 Beach Chair 垫子对接。
c. 使用医院的标准做法转移患者，将患者的臀部放在 Beach Chair 垫子与手术台垫子的交接
处。
d. 为患者插管，在托住患者头部的同时，拉出头枕支撑管组件，直到听到“咔哒”一声。按下按
钮，将头枕组件滑到支撑管上，以重新安装头枕。
e. 松开 Velcro 绑带，将患者的头部放入头枕。收紧前额的 Velcro 绑带，然后将其固定在设备
上方，以固定患者的头部。
f. 对患者头部的 Velcro 绑带进行同样的操作，确保其不会太紧。确保前额垫子正确位于患者的
前额中心，使患者感到更加舒适。此外，应注意确保头枕垫子不会压迫患者的耳朵。
•注意:如果是身高不足 1.5 米（5 英尺）的矮小患者，头枕不能牢牢地盖住患者的头部，可以
将头枕组件从支撑管上拆下来（如前所述），然后将其倒置。您可以通过松开夹子和调整头枕
组件的位置，围绕头枕定位柱旋转头枕组件。这将使您能够将头枕组件降低大约 15.25 cm（6
英寸）。

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A 页码 15
•注意:手术完成后，将头枕组件拆下并旋转回正常方向，以确保其适合正常身材的患者。
3.3. 设备拆卸
如要拆卸 Standard Head Positioner：解开 Velcro® 绑带，将 Standard Head Positioner
从滑轨上拆下。使用插管垫替换。
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。
前额垫子

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A 页码 16
小心： 请勿将衬垫浸入任何液体中
小心： 请勿使用漂白剂或酚类物质清洁垫子

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Side 17
Beach Chair Standard Headrest
F-90016
80028542
Version A

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Side 18
VIGTIGE BEMÆRKNINGER
•Alle advarsler i manualen og på selve enheden skal læses og være forstået
inden brug med 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 patientpleje, hvad angår denne
enhed, er stadig hos den behandlende læge.
•Før hver anvendelse skal det kontrolleres, at enheden fungerer.
•Denne enhed må kun bruges 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 fabrikanten 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: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
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INDHOLDSFORTEGNELSE
1. Kontaktoplysninger
2. Generelle sikkerhedsadvarsler og forholdsregler:
3. Opsætning og brug af udstyret
3.1. Produktspecifikationer
3.2. Opsætning og brug
3.3. Afmontering af udstyr
4. Rengøring og vedligeholdelse

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026387 Ver. B
Document Number: 80028542 Issue Date: 21 MAY 2020
Version: A Side 20
1. Kontaktoplysninger
For klager eller bestillingsoplysninger bedes du kontakte din leverandør og se
kataloget. Alle ændringer, opgraderinger og reparationer skal udføres af en
autoriseret specialist.
2. Generelle sikkerhedsadvarsler og forholdsregler:
ADVARSEL:
a. Undlad at anvende produktet, hvis det har synlige skader.
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 patient og/eller bruger 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, dele mangler, eller hvis enheden ikke fungerer som forventet.
FORSIGTIG: Overskrid ikke enhedens sikre arbejdsbelastning.
3. Opsætning og brug af udstyret
3.1. Produktspecifikationer
Kompatibel med følgende produkter:
•Lift-Assist Beach Chair
•Table-Powered Beach Chair
•Manual Lift Beach Chair
•OR Table Adaptor (kan fastgøres til ethvert kirurgisk leje)
Produktspecifikationer:
•Maksimal patientvægt på 181 kg (400 lbs)
Ideel til brug ved følgende indgreb:
•Reparation af styresene i skulder
•Reparation af skulderled
•Reparation af SLAP-læsion