Hillrom A-71502 User manual

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 1
Adjustable Accessory Rail Clamp
Product No. A-71502, A-71501-US, A-71501-UK,
A-71501-EU, A-71501-JP, A-71501-DEN
80028534
Version A

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 2
ENGLISH........................................................................................................................................3
中文简体......................................................................................................................................14
NEDERLANDS .............................................................................................................................27
FRANÇAIS...................................................................................................................................38
DEUTSCH ....................................................................................................................................49
ITALIANO ....................................................................................................................................61
POLSKI ........................................................................................................................................72
ESPAÑOL ....................................................................................................................................83
SVENSKA.....................................................................................................................................94

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 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.
•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.
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: 80028534 Issue Date: 21 MAY 2020
Version A Page 4
TABLE OF CONTENTS
1Contact Details
2General Safety Warnings and Cautions:
3Equipment set up and use
3.1 Table Compatibility
3.2 Product Specifications
3.3 Adjustable Accessory Rail
3.4 Clamp for Adjustable Accessory Rail
3.5 Prior to use
3.6 Set-Up
3.7 Device Controls and Indicators
3.8 Removal and Storage after use
4Cleaning and Maintenance

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 5
International
North America
1Contact Details
For ordering information please see catalog.
Allen Customer Service Contact Information:
2General 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.
e. All modifications, upgrades, or repairs must be performed by an authorized
specialist.
f. Do not exceed the weight capacity (15.5 lbs, 7.0 kg) of the device. This could
cause injury or damage to the equipment.
g. Do not autoclave.
h. Do not use excessive force when tightening handles. This could cause damage
to the clamp or other equipment.
i. Be aware of potential pinch points when performing the following functions:
•Attaching the clamp to the surgical platform
•Adjusting the position of the rail
•Attaching an accessory to the rail
•Tightening handles
[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: 80028534 Issue Date: 21 MAY 2020
Version A Page 6
j. This product is only intended to be used with surgical retractors, not arm boards
or other accessories, even though they might fit on the rail.
k. The label on the clamp (pictured below) is meant to serve as a reminder that this
Instructions for Use document must be followed for safe operation.
CAUTION:
Do not exceed the device safe working load.
3Equipment set up and use
3.1 Table Compatibility
The Clamp for Adjustable Accessory Rail is compatible for use with the Allen
Advance Rail Top, Allen Advance Flat Top, and Allen Flex Frame. It may also fit on
other surgical platforms with a 1 ½” X 1 ¼” (3.8 cm x 3.2 cm) rail size, but has not
been tested for compatibility with all surgical platforms.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer’s weight limits.
The Adjustable Accessory Rails use industry standard rail sizing for operating room
table rails. Third party retractor clamps that contain appropriately sized clamp jaws
may fit onto the Adjustable Accessory Rail Clamps, but have not been tested for
compatibility. This product is only intended to be used with surgical retractors, not
arm boards or other accessories, even though they might fit on the rail.
3.2 Product Specifications
•Weight limit: Use with retractors weighing 15.5 lbs (7.0 kg) or less.
•Lifetime: The Adjustable Accessory Rail and Clamp have a 5 year useable lifetime.
•Overall Dimensions
A-71502
[53 mm]
2 1/8”
[102 mm]
4”
[39 mm]
1 1/2”
[107 mm]
4 ¼”

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 7
Rail Sizing:
P/N
Width
Height
A-71501-US
3/8” (9.53 mm)
1 1/8” (28.58 mm)
A-71501-EU
0.39" (10 mm)
0.98" (25 mm)
A-71501-UK
1/4" (6.35 mm)
1 1/4" (31.75 mm)
A-71501-DEN
1/4" (6.35 mm)
1 1/2" (38.1 mm)
A-71501-JP
0.35" (9 mm)
1.26" (32 mm)
A-71501-US
A-71501-UK
A-71501-JP
A-71501-DEN
A-71501-EU
(Only difference with EU version is smaller adaptor section as shown.)
NEVER EXCEED THE WEIGHT CAPACITY OF THE
O.R. TABLE
[100 mm]
3 7/8”
[19 mm]
3/4”
[156 mm]
6 1/8”
[19 mm]
3/4”
[203 mm]
8”
[203 mm]
8”

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 8
3.3 Adjustable Accessory Rail
A-71501-US
A-71501-UK
A-71501-EU
A-71501-JP
A-71501-DEN
3.4 Clamp for Adjustable Accessory Rail
A-71502
Accessory
Rail
Table
Clamp
Accessory
Rail Lock
Wedge
Table
Lock
Warning
Label
Serial
Number

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 9
3.5 Prior to use
1. Inspect clamp, accessory rail, and surgical platform for damage prior to each
use. If devices show visible damage do not use.
2. Prior to use, ensure clamp and rails are free of any fluids, residue, or other
contaminants.
3.6 Set-Up
a. Slide Accessory Rail into corresponding hole in clamp and tighten Accessory Rail
Lock. Ensure rail is held tightly and cannot move or slide.
WARNING: Avoid tightening on the very end of the Accessory Rail. Make sure
Accessory Rail is secured to clamp and does not slide prior to use. Failure to do
either could result in sudden retractor movement and patient injury.
b. Fully loosen Table Lock until Wedge is all the way down

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 10
c. Slide the Table Clamp onto the carbon fiber rail of the surgical platform. Ensure
there are no foreign objects between the clamp and the carbon fiber such as
drapes, lines, liquid, etc.
d. Secure by tightening Table Lock Handle. Ensure clamp is held tightly onto the
carbon fiber rail and cannot move or slide.
WARNING: Make sure clamp is secured to surgical platform and does not slide or
rotate prior to use. Failure to do so could result in sudden retractor movement
and patient injury.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 11
3.7 Device Controls and Indicators
Adjusting Depth of Accessory Rail
a. Loosen handle of Accessory Rail Lock.
b. Slide Accessory Rail to desired depth and re-tighten with Accessory Rail Lock.
Ensure rail is held tightly and cannot move or slide.
c. When rail is adjusted as needed, attach desired retractor per manufacturer’s
instructions and ensure that is it securely in place and cannot move or slide on
the Accessory Rail.
WARNING:
•Make sure the patient is not in direct contact with any part of the device
•Make sure retractors are compatible with the Accessory Rail size being used
and are properly secured prior to use. Failure to do so could result in sudden
retractor movement and patient injury

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A Page 12
3.8 Removal and Storage after use
a. Remove retractor per manufacturer’s instructions.
b. Loosen Table Lock and slide device off of carbon fiber rails (reverse steps 3-4 of
Section 3.0.
c. Store device with related equipment per facility protocols.
d. Ensure Accessory Rail Lock handle is tightened securely before storage and
transport to prevent unwanted sliding and potential injury or equipment damage
It is recommended that the device is removed from the surgical platform prior to
moving the surgical platform. The Accessory Rail may reduce doorway
clearance and could be damaged if subject to impact.
4Cleaning and Maintenance
WARNING:
•After each use, clean the device.
•The Adjustable Accessory Rail and Clamp are compatible with the following
cleaning solutions:
oquaternary ammonium disinfecting/cleaning solution
obleach and water solution (1:1 ratio or less)
oWexcide
•Follow the manufacturers recommendation for achieving low-level disinfection.
•Read the cleaning product’s directions and follow the instructions on the label.
•Use caution in areas where fluid migration may occur.
•Wipe device with a clean, dry cloth.
•Make certain the product is dry prior to reinstalling to avoid damage.
•When the product has reached the end of its useful life (5 years), discontinue use
and discard it in accordance with local and federal standards. Recycle as much
as possible.

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A 页码 13
Adjustable Accessory Rail Clamp
产品编号 A-71502、A-71501-US、A-71501-UK、
A-71501-EU、A-71501-JP、A-71501-DEN
80028534
Version A

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A 页码 14
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。
•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。
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: 80028534 Issue Date: 21 MAY 2020
Version A 页码 15
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 手术台兼容性
3.2 产品规格
3.3 可调节附件导轨
3.4 可调节附件导轨夹具
3.5 使用前
3.6 设置
3.7 设备控件和指示灯
3.8 使用后拆卸和存放
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: 80028534 Issue Date: 21 MAY 2020
Version A 页码 16
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。
e. 任何修改、升级或维修都必须由经过授权的专业人员执行。
f. 请勿超过设备的载重量（7.0 kg，15.5 lbs）。这可能导致受伤或设备损坏。
g. 请勿进行高压灭菌。
h. 拧紧手柄时不要过度用力。这可能导致夹具或其他设备损坏。
i. 在执行以下功能时，请注意潜在的夹点：
•将夹具安装到手术平台上
•调整导轨的位置
•将附件安装到导轨上
•紧固手柄
[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: 80028534 Issue Date: 21 MAY 2020
Version A 页码 17
j. 本产品只适用于手术牵开器，而不是臂夹板或其他附件，尽管它们可能适合在导轨上使
用。
k. 夹具上的标签（如下图）是为了提醒大家必须遵守本使用说明文档，以保证安全操作。
小心：
切勿超过设备安全工作负载。
3设备设置和使用
3.1 手术台兼容性
用于可调节附件导轨的夹具可与 Allen Advance Rail 床面、Allen Advance Flat 床面和
Allen Flex Frame 兼容使用。其也可能适用于其他具有 3.8 cm x 3.2 cm (1 ½” X 1 ¼”)
导轨尺寸的手术台，但尚未测试与所有手术平台的兼容性。
注意 : 有关使用说明，请参阅手术台制造商用户指南。请始终遵循手术台制造商的体重限
制。
可调节附件导轨使用行业标准的手术室床面导轨尺寸。包含适当大小夹钳的第三方牵开器夹
具可以安装到可调节附件导轨夹具，但尚未经过兼容性测试。本产品只适用于手术牵开器，
而不是臂夹板或其他附件，尽管它们可能适合在导轨上使用。

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A 页码 18
3.2 产品规格
•重量限制：与重量为 7.0 kg (15.5 lbs) 或以下的牵开器一起使用。
•使用期限：可调节附件导轨和夹具的使用期限为 5 年。
•总体尺寸
A-71501-US
A-71501-UK
A-71501-JP
A-71501-DEN
A-71502
2 1/8”
[53 mm]
3 7/8”
[100 mm]
4”
[102 mm]
1 1/2”
[39 mm]
4 ¼”
[107 mm]
3/4”
[19 mm]
6 1/8”
[156 mm]
3/4”
[19 mm]
8”
[203 mm]

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A 页码 19
导轨尺寸：
P/N
宽度 高度
A-71501-US
9.53 mm (3/8”) 28.58 mm (1 1/8”)
A-71501-EU
10 mm (0.39”) 25 mm (0.98”)
A-71501-UK
6.35 mm (1/4”) 31.75 mm (1 1/4”)
A-71501-DEN
6.35 mm (1/4”) 38.1 mm (1 1/2”)
A-71501-JP
9 mm (0.35”) 32 mm (1.26”)
A-71501-EU
（与欧盟版本的唯一区别是适配器部分较小，如图所示。）
切勿超过手术台的承重能力
8”
[203 mm]

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028534 Issue Date: 21 MAY 2020
Version A 页码 20
3.3 可调节附件导轨
A-71501-US
A-71501-UK
A-71501-EU
A-71501-JP
A-71501-DEN
3.4 可调节附件导轨夹具
A-71502
附件导轨
手术台夹具
附件导轨锁
楔形物
手术台锁
警告标签
序列号