Hillrom A-70500 User manual

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Page 1
Armboard Rail
Product No. A-70500, A-70500-UK, A-70500-EU,
A-70500-DEN, A-70500-JP
80028526
Version A

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Page 2
ENGLISH......................................................................................................................................3
中文简体........................................................................................................................................9
HRVATSKI..................................................................................................................................15
DANSK........................................................................................................................................21
NEDERLANDS ...........................................................................................................................27
SUOMI........................................................................................................................................33
FRANÇAIS..................................................................................................................................39
DEUTSCH...................................................................................................................................45
ΕΛΛΗΝΙΚΑ..................................................................................................................................51
ITALIANO....................................................................................................................................57
LATVISKI....................................................................................................................................63
NORSK.......................................................................................................................................69
POLSKI.......................................................................................................................................75
PORTUGUÊS ............................................................................................................................81
ROMÂNESC...............................................................................................................................87
SLOVENSKY..............................................................................................................................94
SLOVENŠČINA ........................................................................................................................100
ESPAÑOL.................................................................................................................................106
SVENSKA.................................................................................................................................113

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 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: 80028526 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: 80028526 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.
e. For use with ARMBOARDS ONLY.
f. Do not use if product shows visible damage. Do not exceed 400 lbs (181 kg)
patient’s arm weight.
g. To avoid injury to patient, ensure Armboard Rails are properly latched and locked
prior to supporting patient.
h. Remove while transporting Flex Frame through doorways and while loading
patient
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: 80028526 Issue Date: 20 MAY 2020
Version: A Page 6
3. Equipment set up and use
PRODUCT DESCRIPTION
This product is a rail attachment to a spine frame to support the patient’s arm during
surgery. This product is used in combination with an armboard.
SPECIFICATIONS
•400 lbs (181 kg) patient’s arm weight
capacity
•Standard OR rail sizes
•Compatible with Allen Flex Frame
and most competitor spinal tables
with 1 ¼” (3.2 cm) W x 1 ½” (3.8 cm)
H x 17” (43 cm) spaced rails.
SET-UP AND USE
Installation
•Place the Armboard Rails on the Allen Flex Frame.
•Pull down firmly on the clamp latch to lock into place.
•Pull outward on the clamp latch to ensure the clamp
is locked.
Removal
•Push the white clamp locks down to unlock.
•Push up firmly on the clamp latch to release.
•Remove.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 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.
•Clean and disinfect using a quaternary ammonium disinfecting/cleaning solution
following the manufacturers recommendation for achieving low-level disinfection.
•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.
•Do not Autoclave
•Damage may result if product is cleaned with bleach.

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A 页码 8
Armboard Rail
产品编号 A-70500、A-70500-UK、A-70500-EU、
A-70500-DEN、A-70500-JP
80028526
Version A

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 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: 80028526 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: 80028526 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。
e. 仅适用于 Armboard。
f. 如果产品出现明显损坏，请勿使用。请勿超过 181 kg (400 lbs) 患者手臂重量。
g. 为避免对患者造成伤害，承载患者之前，确保 Armboard Rails 已正确锁定。
h. 在Flex Frame 通过门口和承载患者时将其移除
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: 80028526 Issue Date: 20 MAY 2020
Version: A 页码 12
3. 设备设置和使用
产品描述
本产品是脊柱框架的一个导轨附件，用于在手术期间支撑患者的手臂。本产品与臂夹板结合
使用。
规格
•181 kg (400 lbs) 的患者手臂载重量
•标准手术室导轨尺寸
•与Allen Flex Frame 和大多数导轨尺
寸为 3.2 cm (1 ¼”) 宽x 3.8 cm
(1 ½”) 高x 43 cm (17”) 长的脊柱手
术台兼容
设置和使用
安装
•将Armboard Rails 放在 Allen Flex Frame 上。
•用力向下按压夹具闩锁，以锁定就位。
•向外拉动夹锁确保夹锁已锁定。
拆卸
•按下白色夹锁以解锁。
•向上用力推动夹具闩锁，以进行释放。
•拆卸。

使用说明
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 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。
•遵照制造商建议，使用季铵消毒/清洁溶液进行清洁和消毒，实现基本消毒。
•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。
•请勿进行高压灭菌
•使用漂白剂清洁本产品可能会造成损坏。

Upute za upotrebu
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Stranica 14
Armboard Rail
Proizvod br. A-70500, A-70500-UK, A-70500-EU,
A-70500-DEN, A-70500-JP
80028526
Version A

Upute za upotrebu
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Stranica 15
VAŽNE NAPOMENE
•Prije upotrebe na pacijentu s razumijevanjem pročitajte sva upozorenja
navedena u ovom priručniku i na samom uređaju.
•Simbol služi kao upozorenje korisniku na važne postupke ili sigurnosne
upute o upotrebi ovog uređaja.
Simbol na naljepnicama pokazuje kada treba pročitati upute za
upotrebu.
•Tehnike opisane u ovom priručniku samo su preporuke proizvođača. Za
brigu o pacijentu u vezi s ovim uređajem u konačnici je odgovoran
zaduženi liječnik.
•Prije svake uporabe treba provjeriti funkciju uređaja.
•Ovim uređajem smije rukovati samo obučeno osoblje.
•Sve izmjene, nadogradnje ili popravke mora obaviti ovlašteni stručnjak.
•Čuvajte ovaj priručnik pri ruci za kasniju upotrebu.
•Svaki ozbiljan incident koji se dogodi, a vezan je uz uređaj, treba prijaviti
proizvođaču i nadležnom tijelu navedenom u ovom dokumentu.
Ovaj je uređaj dio medicinskog uređaja visoke razine. Prije upotrebe
ovog ili bilo kojeg drugog medicinskog uređaja na pacijentu
preporučuje se da pročitate Upute za upotrebu i upoznate se s
proizvodom.

Upute za upotrebu
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Stranica 16
SADRŽAJ
1. Pojedinosti o kontaktu
2. Opća sigurnosna upozorenja i mjere opreza:
3. Postavljanje i upotreba opreme
4. Čišćenje i održavanje

Upute za upotrebu
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Stranica 17
Pozivi iz
inozemstva
Sjeverna
Amerika
1. Pojedinosti o kontaktu
Informacije o naručivanju potražite u katalogu.
Informacije o kontaktu službe za kupce tvrtke Allen:
2. Opća sigurnosna upozorenja i mjere opreza:
UPOZORENJE:
a. Nemojte upotrebljavati proizvod ako pokazuje vidljivo oštećenje.
b. Prije upotrebe ovog uređaja pročitajte upute za postavljanje i upotrebu opreme.
Prije korištenja na pacijentu upoznajte se s proizvodom.
c. Kako biste spriječili ozljedu pacijenta i/ili korisnika i/ili oštećenje opreme, prije
upotrebe provjerite ima li eventualnih oštećenja ili znakova istrošenosti na uređaju
i bočnim vodilicama kirurškog stola. Nemojte upotrebljavati uređaj ako su prisutna
vidljiva oštećenja, ako nedostaju dijelovi ili uređaj ne funkcionira u skladu s
očekivanjima.
d. Kako biste spriječili ozljedu pacijenta i/ili korisnika i/ili oštećenje opreme, provjerite
leže li stezaljke za pričvršćivanje uređaja u potpunosti na bočnim šipkama stola i
jesu li dobro učvršćene. Provjerite blokirni mehanizam kako biste se uvjerili da ne
dolazi do pomicanja pri podizanju ili guranju.
e. Za upotrebu ISKLJUČIVO S OSLONCIMA ZA RUKU.
f. Nemojte upotrebljavati proizvod ako pokazuje vidljivo oštećenje. Nemojte
prekoračiti ograničenje u pogledu težine ruke pacijenta od 181 kg (400 lb).
g. Kako bi se izbjegla ozljeda pacijenta, pobrinite se da su vodilice za oslonac za
ruku pravilno zakvačene i zaključane prije držanja pacijenta.
h. Uklonite ih pri nošenju okvira Flex Frame kroz vrata i pri postavljanju pacijenta
OPREZ:
Nemojte prekoračiti sigurno radno opterećenje uređaja.
[phone]
[phone], izravna linija 4286
[phone]
[phone]

Upute za upotrebu
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Stranica 18
3. Postavljanje i upotreba opreme
OPIS PROIZVODA
Ovaj se proizvod sastoji od vodilice pričvršćene na okvir za držanje ruke pacijenta tijekom
operacije. Proizvod se upotrebljava u kombinaciji s osloncem za ruku.
SPECIFIKACIJE
•Kapacitet težine ruke pacijenta od
181 kg (400 lb)
•Standardne veličine vodilica za
operacijski stol
•Kompatibilno s okvirom Allen Flex
Frame i većinom konkurentskih
stolova za kralježnicu s vodilicama
razmaknutima za 3,2 cm (1¼”) Š x
3,8 cm (1½”) V x 43 cm (17”)
POSTAVLJANJE I UPOTREBA
Postavljanje
•Postavite vodilice za oslonac za ruku na okvir Allen
Flex Frame.
•Čvrsto povucite hvatač stezaljke kako bi sjeo na
mjesto.
•Povucite hvatač stezaljke prema van kako biste se
pobrinuli da je stezaljka zaključana.
Uklanjanje
•Pritisnite bijele blokade stezaljke za otključavanje.
•Snažno pritisnite hvatač stezaljke kako biste ga otpustili.
•Uklonite.

Upute za upotrebu
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Stranica 19
4. Čišćenje i održavanje
UPOZORENJE:
•Za čišćenje uređaja nemojte upotrebljavati izbjeljivač ili proizvode koji ga sadrže.
Može doći do ozljede ili oštećenja opreme.
•Nakon svake upotrebe očistite uređaj maramicama na bazi alkohola.
•Čišćenje i dezinfekciju obavljajte otopinom za dezinfekciju/čišćenje s kvaternim
amonijevim spojevima, pridržavajući se preporuka proizvođača za dezinfekciju niske
razine.
•Uređaj nemojte stavljati u vodu. Može doći do oštećenja opreme.
•Krpom i otopinom za dezinfekciju/čišćenje na bazi kvaternog amonijevog klorida
očistite i dezinficirajte uređaj.
•Pročitajte i slijedite proizvođačeve preporuke za dezinfekciju niske razine.
•Pročitajte i slijedite upute za sredstvo za čišćenje. Budite oprezni na područjima gdje
tekućina može dospjeti u mehanizam.
•Obrišite uređaj čistom i suhom krpom.
•Uvjerite se da je uređaj suh prije nego što ga spremite ili ponovno upotrijebite.
•Nemojte sterilizirati u autoklavu
•Ako proizvod čistite izbjeljivačem, može doći do oštećenja.

Brugsanvisning
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028526 Issue Date: 20 MAY 2020
Version: A Side 20
Armboard Rail
Varenr. A-70500, A-70500-UK, A-70500-EU,
A-70500-DEN, A-70500-JP
80028526
Version A