Hillrom HUG-U-VAC User manual

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
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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
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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
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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
© 2019 Allen Medical Systems Inc. ALL RIGHTS RESERVED.
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).

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

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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

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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

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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: [phone]
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 [phone]

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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
Axillary Pillow
Pump
Straps to Secure to OR Table
(2 per side)
Tether
Lock

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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
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

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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.

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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.

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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.

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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.

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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.

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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.

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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.
Not Applicable.
Software Specifications
Description
Not Applicable.
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