Hillrom A-60003 Instrucțiuni de utilizare

HUG-U-VAC

Instructions for Use

Product No. A-60003, A-60002

80028181

Version B

INSTRUCTIONS FOR USE 
Document Number: 80028181 Page 2  Issue Date: 27 MAR 2020 
 
Version: B    Ref Blank Template: 80025117 Ver. F 
 
ENGLISH .......................................................................................................................................... 3 
中文简体 ........................................................................................................................................ 23 
NEDERLANDS ................................................................................................................................ 43 
FRANÇAIS ..................................................................................................................................... 65 
DEUTSCH ....................................................................................................................................... 86 
ΕΛΛΗΝΙΚΑ ................................................................................................................................... 106 
ITALIANO ..................................................................................................................................... 127 
LATVISKI ....................................................................................................................................... 147 
POLSKI ......................................................................................................................................... 167 
PORTUGUÊS ................................................................................................................................ 188 
ROMÂNESC ................................................................................................................................ 208 
SRPSKI .......................................................................................................................................... 231 
SLOVENSKY ................................................................................................................................. 252 
SLOVENŠČINA ............................................................................................................................ 273 
ESPAÑOL ..................................................................................................................................... 293 
 
   

INSTRUCTIONS FOR USE

Document Number: 80028181 Page 3 Issue Date: 27 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

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.

INSTRUCTIONS FOR USE 
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Version: B    Ref Blank Template: 80025117 Ver. F 
Table of Contents 
HUG-U-VAC Lateral Positioner (A-60003, A-60002) 
1. General Information: ........................................................................................................... 6 
 Copyright Notice: ........................................................................................................ 6 
 Trademarks: .................................................................................................................. 6 
 Contact Details: ........................................................................................................... 7 
 Safety Considerations: ................................................................................................ 7 
1.4.1 Safety hazard symbol notice: ........................................................................... 7 
1.4.2 Equipment misuse notice: ................................................................................. 7 
1.4.3 Notice to users and/or patients: ...................................................................... 7 
1.4.4 Safe disposal: ...................................................................................................... 8 
 Operating the system: ................................................................................................ 8 
1.5.1 Applicable Symbols: .......................................................................................... 8 
1.5.2 Intended User and Patient Population: .......................................................... 9 
1.5.3 Compliance with medical device regulations: ........................................... 10 
 EMC considerations: .................................................................................................. 10 
 EC authorized representative: ................................................................................. 10 
 Manufacturing Information: ..................................................................................... 10 
 EU Importer Information: ........................................................................................... 10 
 Australian sponsor Information: ............................................................................... 10 
2. System .................................................................................................................................. 11 
 System components Identification: ........................................................................ 11 
 Product Code and Description: .............................................................................. 11 
 List of Accessories and Consumable Components Table: .................................. 12 
 Indication for use: ...................................................................................................... 12 
 Intended use: ............................................................................................................. 12 
 Residual Risk: ............................................................................................................... 12 
3. Equipment Setup and Use: ............................................................................................... 13 
 Prior to use: ................................................................................................................. 13 
 Setup: .......................................................................................................................... 13 
 Device controls and indicators: .............................................................................. 17 
 Storage, Handling and Removal Instructions: ....................................................... 18 

INSTRUCTIONS FOR USE 
Document Number: 80028181 Page 5  Issue Date: 27 MAR 2020 
 
Version: B    Ref Blank Template: 80025117 Ver. F 
3.4.1 Storage and Handling: .................................................................................... 18 
3.4.2 Removal Instruction: ........................................................................................ 18 
 Troubleshooting Guide: ............................................................................................ 18 
 Device Maintenance: ............................................................................................... 18 
4. Safety Precautions and General Information: ............................................................... 18 
 General Safety Warnings and Cautions: ................................................................ 18 
 Product Specifications: ............................................................................................. 19 
 Sterilization Instruction: .............................................................................................. 20 
 Cleaning and Disinfection Instruction: .................................................................... 21 
5. List of Applicable Standards: ............................................................................................ 21 
 
   

INSTRUCTIONS FOR USE

Document Number: 80028181 Page 6 Issue Date: 27 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

1. General Information:

Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc., (NYSE: HRC), a leading

worldwide manufacturer and provider of medical technologies and related services

for the health care industry. As an industry leader in patient positioning, our passion is

improving patient outcomes and caregiver safety, while enhancing our customers'

efficiency. Our inspiration comes from providing innovative solutions to address our

customers' most pressing needs. We immerse ourselves in our customers' world, to

better address these needs and the daily challenges of their environment. Whether

developing a solution to address patient positioning challenges or creating a system

to offer safe and effective surgical site access for the surgical team, we are committed

to providing products of exceptional value and quality.

Allen products are backed by responsive and reliable service and complimentary on-

site product demonstrations.

Copyright Notice:

Revision

No part of this text shall be reproduced or transmitted in any form or by any means,

electronic or mechanical, including photocopying, recording, or by any information

or retrieval system without written permission from Allen Medical Systems, Inc. (Allen

Medical).

The information in this manual is confidential and may not be disclosed to third

parties without the prior written consent of Allen Medical.

Trademarks:

Trademark information can be found at Allenmedical.com/pages/terms-conditions.

Products may be covered by one or more patents. Please consult listing at

Hill-rom.com/patents for any patent(s).

INSTRUCTIONS FOR USE

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Contact Details:

For ordering information please see catalog.

Allen Customer Service Contact Information:

Safety Considerations:

1.4.1 Safety hazard symbol notice:

DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL

DEGRADATION.

1.4.2 Equipment misuse notice:

Do not use the product if package is damaged or unintentionally opened before use.

All modifications, upgrades, or repairs must be performed by an authorized specialist.

1.4.3 Notice to users and/or patients:

Any serious incident that has occurred in relation to the device should be reported to

the manufacturer and the competent authority of the Member State in which the

user and/or patient is established.

Note: Refer to the surgical table manufacturer's user guide for instructions on use.

Always refer to the surgical table manufacturer’s weight limits.

NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE

North America

International

(800) 433-5774

+1 978 266 4200 ext. 4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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1.4.4 Safe disposal:

Customers should adhere to all federal, state, regional, and/or local laws and

regulations as it pertains to the safe disposal of medical devices and accessories.

If in doubt, the user of the device shall first contact Hill-Rom Technical Support for

guidance on safe disposal protocols.

Operating the system:

1.5.1 Applicable Symbols:

Symbol used

Description

Reference

Indicates the device is a medical

device

MDR 2017/745

Indicates the medical device

manufacturer

EN ISO 15223-1

Indicates the manufacturer’s serial

number. The device serial number is

encoded as 1YYWWSSSSSSS.

 YY indicates the year of

manufacture. i.e. 118WWSSSSSSS

where 18 represents the year 2018.

 WW indicates the number of the

manufacturing week per a

standard shop calendar. (Leading

zeros included.)

 SSSSSSS is a sequential unique

number.

EN ISO 15223-1

Indicates the medical device Global

Trade Item Number

21 CFR 830

MDR 2017/745

Indicates the manufacturer’s lot code

using the Julian Date yyddd, where yy

indicates the last two digits of the year

and ddd indicates the day of the year.

i.e. April 4th, 2019 would be represented

as 19094.

EN ISO 15223-1

INSTRUCTIONS FOR USE

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Indicates the date when the medical

device was manufactured

EN ISO 15223-1

Indicates the manufacturer’s

catalogue number

EN ISO 15223-1

Indicates the need for the user to

consult the instructions for use for

important cautionary information such

as warnings and precautions.

EN ISO 15223-1

Indicates the device do not contain

natural rubber or dry natural rubber

latex

EN ISO 15223-1

Indicates the authorized representative

in the European Community

EN ISO 15223-1

Indicates the Medical Device complies

to REGULATION (EU) 2017/745

MDR 2017/745

Indicates a Warning

IEC 60601-1

Indicates the need for the user to

consult the instruction for use

EN ISO 15223-1

1.5.2 Intended User and Patient Population:

Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare

professionals involved in the device intended procedure. Not intended for Lay

persons.

Intended Populations:

This device is intended to be used with patients that do not exceed the weight in the

safe working load field specified in the product specification section 4.2

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

1.5.3 Compliance with medical device regulations:

This Product is a non-invasive, Class I Medical Device. This system is CE-

marked according to Annex VIII, Rule 1, of the Medical Device

Regulations (REGULATION (EU) 2017/745)

EMC considerations:

This is not an electromechanical device. Therefore, EMC Declarations are not

applicable.

EC authorized representative:

HILL-ROM SAS

B.P. 14 - Z.I. DU TALHOUET

56330 PLUVIGNER

FRANCE

TEL: +33 (0)2 97 50 92 12

Manufacturing Information:

ALLEN MEDICAL SYSTEMS, INC.

100 DISCOVERY WAY

ACTON, MA 01720 USA

800-433-5774 (NORTH AMERICA)

978-266-4200 (INTERNATIONAL)

EU Importer Information:

TRUMPF Medizin Systeme GmbH + Co. KG

Carl-Zeiss Straße 7-9

07318 Saalfeld/Saale

Germany

Australian sponsor Information:

Welch Allyn Australia Pty. Ltd.

Unit 4.01, 2-4 Lyonpark Road

Macquarie Park, NSW 2113

Phone 1800 650 083

INSTRUCTIONS FOR USE

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2. System

System components Identification:

Product Code and Description:

A-60003 - Hug-U-Vac Standard Lateral Positioner

A-60002 - Hug-U-Vac Large Lateral Positioner

Vacuum Valve

Axillary Pillow

Pump

Straps to Secure to OR Table

(2 per side)

Tether

Lock

INSTRUCTIONS FOR USE

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List of Accessories and Consumable Components Table:

The following list are accessories and components that may be used with this

device.

Name of Accessory

Product Number

Not Applicable

Note: Consult the corresponding IFU for the products mentioned in the above table.

CAUTION: Reuse of disposables will lead to patient cross contamination and/or

device failure.

Indication for use:

The Hug-U-Vac Lateral Positioner is used in a variety of surgical procedures including,

but not limited to arthroscopic or open Orthopedic surgery. These devices are

capable of being used with a broad patient population as determined appropriate

by the caregiver or institution.

Intended use:

The Hug-U-Vac Lateral Positioner is designed to Stabilize patient on OR table in a

variety of surgical procedures including, but not limited to arthroscopic or open

Orthopedic surgery. These devices are intended to be used by healthcare

professionals within the Operating Room setting.

Residual Risk:

This product complies with relevant performance, safety standards. However,

patient, user or device harm from misuse, device damage or malfunction, device,

function or mechanical hazards cannot be completely excluded.

Name of Consumable

Product Number

Standard Allen Hug-U-Vac

Lateral Disposable Covers

A-60103

Large Allen Hug-U-Vac

Lateral Disposable Covers

A-60102

INSTRUCTIONS FOR USE

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3. Equipment Setup and Use:

Prior to use:

a. Inspect the product looking for any visible damage or sharp edges that could be

caused by a drop or impact during storage.

b. Make sure product has been properly cleaned and disinfected and wiped dry

prior to each use.

Setup:

a. Place the Hug-U-Vac® on the Operating Room (OR) table for final patient position.

 Align the positioner longitudinally on the OR table with the bottom edge

approximately aligned with the perineal cut-out.

b. Secure the Hug-U-Vac® straps to the side rails of the OR table in such a way that

the positioner is centered on the OR table.

A) Thread free end

of strap behind side

rail of OR table.

B) Thread end up

through bottom of

top buckle slot.

C) Thread end

down through

remaining slot in

buckle.

D) Grab hold of

free end and

cinch tight.

INSTRUCTIONS FOR USE

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c. Smooth out the Hug-U-Vac® so that the internal microbeads are evenly

distributed throughout the positioner.

d. Evacuate a small amount of air from the Hug-U-Vac® so that the beads do not

redistribute when patient is moved onto the positioner. Then close the valve.

e. Fit the disposable slipcover onto the Hug-U-Vac® per the disposable instructions.

INSTRUCTIONS FOR USE

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f. Transfer the patient onto the positioner.

g. Open the valve and allow the Hug-U-Vac® to relax.

Position the patient in the lateral position, with their torso centered along the

length of the Hug-U-Vac® ensuring the Axillary Pillow is inferior to the axilla.

h. Using the hand bulb, inflate the Axillary Pillow to remove pressure from the

dependant arm and shoulder.

INSTRUCTIONS FOR USE

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i. For procedures inferior to the thorax (i.e.

nephrectomy, hip) use the Axillary Pillow

in the standard position. For procedures

including the thorax and superior (i.e.

thoracotomy, shoulder) flip the Axillary

Pillow forward to provide greater upper

body support.

j. With the valve open, approximate the

sides of the Hug-U-Vac® to the anterior

and posterior aspects of the patient

making certain that the Hug-U-Vac®

does not impinge on the surgical field.

k. Evacuate the air from the

Hug-U-Vac® by attaching

surgical suction to the barbed

end of the open valve.

l. When sufficiently firm

close and lock the

valve and remove

the suction hose.

WARNING!

Once the desired form is obtained around the patient, DO NOT

leave suction applied to the device. Close the Hug-U-Vac valve and stop

suction during the procedure. After the procedure is completed, release

the Hug-U-Vac valve and allow air to return into the device.

Ensure that the valve is held

securely by the nozzle when

removing suction tubing or valve

damage may occur.

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

Device controls and indicators:

Controls and indicators of this device are described within the Setup instructions.

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE

ALWAYS LOCK VALVE CLOSE AND REMOVE SUCTION TUBE

When NO space is visible

between the couplings, the

valve is in the Open position.

Push two couplings of

valve together until an

audible click is heard.

To Open Valve

When space is visible between

couplings, the valve is in the

Closed position.

Press the metal thumb latch on top

of valve to CLOSE the valve, an

audible click should be heard.

To Close Valve

To Lock Valve

Press the plastic

lock clip into the

gap of the closed

valve until it clicks

into place.

INSTRUCTIONS FOR USE

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Storage, Handling and Removal Instructions:

3.4.1 Storage and Handling:

The product should be stored in a clean and safe environment to prevent product

damage. See storage Specifications under Product Specification section.

3.4.2 Removal Instruction:

Removal is the reverse of installation.

Troubleshooting Guide:

This device does not have a troubleshooting guide. For technical support user of the

device shall first contact Hill-Rom Technical Support.

Device Maintenance:

Make sure that all labels are installed and can be read. Replace labels as necessary

by using a plastic scraper to remove the label. Use an alcohol wipe to remove any

adhesive residue.

Contact Allen Medical Systems, Inc. if you need to repair or replace the device

contact us using the information from the contact details section (1.3).

4. Safety Precautions and General Information:

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. Ensure that the valve is held securely by the nozzle when removing suction tubing

or valve damage may occur.

DO NOT

leave the Hug-U-Vac valve closed with suction still applied in

between procedures or in storage. Leaving the suction connected will lead

to collapsing and damage of the internal beads and thus, greatly reduce

the life of the product.

INSTRUCTIONS FOR USE

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e. It is recommended that this positioner be is used in conjunction with a rigid lateral

support in order to prevent patient injury or death in the event the product loses

vacuum.

f. Always ensure product is properly and securely fastened to the operating table

prior to use.

g. Secure positioners straps only to the operating table’s accessory rails.

h. Never secure positioners straps to table width extenders or any secondary

accessory rails.

i. Always ensure the vacuum valves are securely closed and locked, and that the

positioner maintains vacuum prior to draping the patient or beginning any surgical

procedure.

j. Do not exceed the maximum patient weight limit or width as specified by the

manufacturer.

k. Not for use with K-Thermal heating pads or similar.

l. Once the desired form is obtained around the patient, DO NOT leave suction

applied to the device. Close the Hug-U-Vac valve and stop suction during the

procedure. After the procedure is completed, release the Hug-U-Vac valve and

allow air to return into the device.

m. Do not leave the Hug-U-Vac valve closed with suction still applied in between

procedures or in storage. Leaving the suction connected will lead to collapsing

and damage of the internal beads and thus, greatly reduce the life of the product.

n. Never exceed the weight capacity of the OR table.

o. Always lock valve close and remove suction tube.

CAUTION:

Do not exceed safe working load shown in the product specification table

Product Specifications:

Mechanical Specifications

Description

Product Dimensions

Hug-U-Vac® Standard Lateral Positioner:

35”X 48” (89 cm x 122 cm)

Hug-U-Vac® Large Lateral Positioner:

32”X 36” (81.3 cm x 91.5 cm)

Material

Devices are constructed from traditional

engineering materials including stainless steel,

aluminum, and padding is made from high and

low temperature polymers.

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

Note: Consult the corresponding IFU for the products mentioned in the above table.

Sterilization Instruction:

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

Safe Working Load on the device

Hug-U-Vac® Standard Lateral Positioner:

500 lbs. (226 kg) patient

Hug-U-Vac® Large Lateral Positioner:

800 lbs. (362.8 kg)

Overall Weight of Complete Device

Hug-U-Vac® Standard Lateral Positioner:

8lbs. (3.6 kg)

Hug-U-Vac® Large Lateral Positioner:

10lbs. (4.5 kg)

Storage Specifications

Description

Storage temperature

-29 °C to +60 °C

Storage Relative humidity range

15% to 85%

Operating temperature

This device is intended to be used in a

controlled Operating Room environment.

Operating Relative humidity range

Electrical Specifications

Description

Not Applicable.

Software Specifications

Description

Not Applicable.

Compatibility Specifications

Description

Operating Room Table Compatibility

The Hug-U-Vac is compatible with the following

surgical table rail styles: US, UK, EU, DEN, JP,

SWISS

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