Direct Supply ZERO OPENING ASSIST User manual

Direct Supply®
ZERO OPENING
ASSIST DEVICE
Please keep and refer to this Owner’s Manual.
Owner’s Manual
1-800-634-7328 DirectSupply.com
Thank you for purchasing a Direct Supply®Zero Opening Assist Device from Direct Supply Equipment & Furnishings®.
Please read this entire guide carefully and keep it for future reference. This guide provides instructions, warnings, warranty
information and other important information about your zero opening assist. Share this information with your housekeeping,
nursing and maintenance staff to help ensure the zero opening assist device is cared for properly.

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Table of Contents,
Description & Intended Use, Capacity
Table of Contents
Description & Intended Use ...............................................................................................2
Capacity..............................................................................................................................2
Warnings ............................................................................................................................3
Installation .....................................................................................................................4 - 7
Operation............................................................................................................................8
Maintenance.......................................................................................................................9
Limited Warranty .............................................................................................................. 10
Customer Service............................................................................................................. 11
Description & Intended Use
This assist device is designed to fit multiple brands and models of beds. This device is only
compatible with beds that are designed to accept assist devices which are mounted via holes
in the bed’s head deck. See the installation section of this manual for information about device
setup and ensuring compatibility and safety. This device is not a bedrail and is not intended to
function as a bedrail.
Capacity
The assist device has been designed and tested to meet or exceed the application of forces
specified by the International Safety Standard IEC60601-2-52, ”Particular requirements for the safety
of electrically operated hospital beds” figure 113. Do not exceed the weight or force limitations
associated with your bed and/or assist devices manufactured for use with your bed.

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Important Warnings
• WARNING: Risk of serious injury or death.This
product is intended only for use with beds that are
capable of supporting assist devices via mounting holes
in the bed’s head deck.This assist device is designed for
use only on beds with assist device mounting holes which
align with the slots provided on the assist’s mounting
plate. Do not modify the assist device or your bed if the
holes do not align. Do not use this device with any other
model or brand of bed. Use of this product on any bed
it was not designed for could result in an unproven or
unsafe configuration, potentially resulting in serious injury
or death. For questions regarding compatibility, contact
your Direct Supply account manager.
• WARNING:This assist device is designed to fit
multiple models of beds and can be configured to pivot to
various positions. It may be possible to install this device
in a manner which could result in entrapment concerns,
resident injury and/or damage to your bed.
• WARNING: This assist device is designed to pivot to
four positions, enabling the device to be mounted to either
side of a bed. Failure to use the pivot-lock system will allow
the device to pivot toward the floor, potentially creating a
crush hazard and/or a risk of damage to your bed.
• WARNING: This manual covers the Direct Supply
Zero Opening Assist Device. For warnings and
instructions related to the bed itself, please see your
bed’s Owner’s Manual. Be sure to read and follow all
instructions and warnings in both manuals.
Bed System Entrapment Information
In April 1999, the U.S. Food and Drug Administration
(FDA) in partnership with representatives from the
hospital and Post-Acute bed industry, national healthcare
organizations, resident and patient advocacy groups, and
other federal agencies formed the Hospital Bed Safety
Workgroup (HBSW).The workgroup’s goal is to improve
the safety of bed frames for residents and patients
in all healthcare settings who are most vulnerable to
the risk of entrapment.The efforts of the FDA and the
HBSW culminated in the FDA’s release of recommended
guidelines intended to reduce the risk of entrapment,
including dimensional limits for critical gaps and spaces
between bed system components and clinical guidance
for assessment and implementation of bed assist rails in
various healthcare settings. Entrapment zones involve the
relationship of bed components often directly assembled
by the healthcare facility rather than the manufacturer.
Therefore, compliance is the responsibility of the facility.
• WARNING: Only use the included hardware to attach
this assist device to a bed. Do not substitute hardware.
• WARNING: Risk of serious injury or death. Use
a properly sized mattress in order to minimize the
gap between the side of the mattress and the assist
device.This gap must be small enough to prevent a
resident from getting his or her head or neck caught
in this location. Make sure raising or lowering the
bed, or articulating the sleep surface, does not create
hazardous gaps. Failure to do so could result in serious
injury or death.
• WARNING: Risk of serious injury or death. Do not
use this assist device if any openings within the assist
device body will allow a resident to get his or her head
or neck lodged within these openings. Failure to do so
could result in serious injury or death.
• WARNING: Risk of serious injury or death. Do not
use this assist device until you have verified it is locked
in place. Injury to resident or caregiver may result if
this procedure is not followed.
• WARNING: An optimal bed system assessment
should be conducted on each resident by a qualified
clinician or medical provider to ensure maximum safety
of the resident. The assessment should be conducted
within the context of, and in compliance with, the
state and federal guidelines related to the use of
restraints and bed system entrapment guidance,
including the Clinical Guidance for the Assessment
and Implementation of Side Rails published by the
Hospital Bed Safety Workgroup of the U.S. Food and
Drug Administration.
• WARNING: In the event worn or broken parts
are identified, remove the device from service until
repairs are made. Do not use substitute parts. Use
only approved replacement parts. Non-approved
replacement parts could cause entrapment, personal
injury and damage to assist devices.
NOTE:The assist device is intended for use as an
aid in entering or exiting the bed sleep area, as well
as a stable handhold during self-positioning within
the bed sleep area. The devices may deform or
break when subjected to excessive side pressure.
Do not exert excessive side pressure on the assist
devices. Do not use them as push handles for
moving the bed. These activities could result in
personal injury and damage to the assist devices
and/or your bed.
This assist device is only one part of your healthcare bed
system. Proper combinations of bed, mattress, head/
foot panels and assist rails are needed to minimize the
risk of entrapment. For more information, contact your
Direct Supply account manager.
• WARNING: Do not permit residents to climb over
the device.
• WARNING: Some states may prohibit assist devices
or consider assist devices to be resident restraints in all
or some instances. Always assess whether this assist
device may meet the definition of a restraint on a
case-by-case basis and document the need for any
resident restraint. Contact your state surveyor for
further guidance regarding assist devices and restraints.
Warnings

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Installation
Tools Required:
• 19 mm combination wrench or socket wrench
• 8 mm Allen wrench (hex wrench)
• 3 mm Allen wrench (hex wrench)
1. Verify your bed has ½" or 5⁄8" diameter assist
device mounting holes available.
• WARNING: Do not use the Direct Supply
Zero Opening Assist Device if your bed is not
designed to receive assist devices via the
required sized holes.
Note about hole placement:The mounting slots on your assist device are not evenly spaced,
and your assist device can be mounted with either set of slots facing either direction (right or left).
If setting up devices on both sides of a bed, align slots so assists on opposite sides of the bed
are oriented as mirror images of each other. Additionally, check the orientation of the assist when
installing the assist for the first time; the position of the assist can be adjusted 1" to 2" by rotating
the mounting plate 180 degrees before installation.
2. Align the assist device mounting plate with the
mounting holes in your bed deck. Ensure there
are two slots in the assist device mounting plate
which align with your bed’s mounting holes.
• WARNING: Do not use the Direct Supply Zero Opening Assist Device if the slots do not align
with your bed’s assist device mounting holes.
16" 18"

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4. Set the pivot lock by inserting one or two set screws into the pivot lock holes in the back of the assist
device mounting plate. See chart below for placement instructions:
To pivot to three positions: To pivot to two positions: To use as non-pivoting assist:
Insert one set screw into
hole A (right hole with handle
pointing up) using a 3 mm
Allen (hex) wrench. Fully insert
but do not tighten.
Insert one set screw into hole
A and one set screw into
either hole D or hole B (will
prevent pivoting in the opposite
direction of screw placement).
Fully insert but do not tighten.
Insert one set screw into hole
B and one set screw into hole
D using a 3 mm Allen (hex)
wrench. Fully insert but do
not tighten.
*NOTE – hole placement on
BACK of assist device *NOTE – hole placement on BACK of assist device *NOTE – hole placement on BACK of assist device
• WARNING: Do not allow the assist device to pivot in all four directions. Allowing the device to pivot
toward the floor may potentially create a crush hazard and/or damage to your bed.
3. Determine which direction(s) you want the
assist device to pivot (up, right, left).
or
D+A
B
C
D
B
A
D
and
B
A
C
D
B
D
C
B
A
A

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5. Mount the assist device mounting plate to your bed using the
provided bolts, nuts and washers.
• Correct order of hardware: Bolt ➔Assist Device ➔Bed Deck
➔Flat Washer ➔Nut
• Using a 19 mm combination wrench or socket wrench and an
8 mm Allen wrench, securely tighten both sets of hardware
• WARNING: Only use the included hardware to attach this
assist device to a bed. Do not substitute hardware. Safe
installation requires use of all provided attachment hardware.
Installation (cont.)
6.
To prevent rapid height adjustment or removal of the assist,
use the included nut and bolt to secure the assist handle to
the support tube.
Insert the assist handle into
the support tube on the assist
device mounting plate.
For quick-release adjustment
of handle height and quick
removal of the assist handle,
use the included retention pin.
Position the assist at the
desired height setting and
then secure the assist with the
included retention hardware.

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7. Before putting the assist device into use, review the installation and overall bed system for
functionality and safety:
a. Assist device should feel solid and stable. Ensure 50 lbs. of force can be exerted on the assist
in any direction without damage or permanent deflection.
b. Verify the device can be pivoted to the desired directions and that the pivot-lock system is
preventing pivoting in other directions.
NOTE – In some configurations, this assist may contact the bed’s headboard when pivoted
toward the head of the bed. If this occurs on your installation, you may be able to prevent the
contact by lowering the height of the assist handle. Alternatively, adjust the pivot-lock system
to prevent pivoting toward the head of the bed (see step #4 for guidance on how to set up your
pivot-lock system)
c. Review the overall bed system for compliance to FDA entrapment guidelines, state and local
regulations, and your company’s policies. Do not use the bed system until all entrapment
concerns have been addressed and resolved.
• WARNING: Prior to use, an optimal bed system assessment must be conducted for each
resident by a qualified clinician or medical provider to ensure maximum safety of the resident. The
assessment should be conducted within the context of, and in compliance with, the state and
federal guidelines related to the use of restraints and bed system entrapment guidance, including
the Clinical Guidance for the Assessment and Implementation of Side Rails published by the
Hospital Bed Safety Workgroup of the U.S. Food and Drug Administration.

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Operation
1. While pulling handle out, rotate assist device left or right 90 degrees.
NOTE: Do not rotate assist device more than 90 degrees.
2. Rotate handle to lock into position.
3. Adjust handle height by removing the release pin or bolt, moving the handle to the desired position,
and then reinserting pin or bolt.

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Routine Inspection
1. Review the “WARNINGS” listed in this manual and inspect for compliance.
2. Inspect all components for damage or excessive wear.
3. Visually examine all welds for cracks.
4. Tighten attachment bolts and center pivot screw.
5. Inspect all bolts and fasteners. (Do not overtighten bolts at pivot points.)
Cleaning
Clean with a mild solution of antiseptic cleaner and warm water. Read and follow all label instructions
on the cleaning products. DO NOT STEAM OR PRESSURE WASH.
Maintenance

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Limited Warranty
We offer to you, as the original purchaser, a warranty for the Direct Supply Zero Opening
Assist. Our warranty applies for the limited warranty period stated below. If any device or
device part listed below is defective in material or workmanship during the applicable limited
warranty period, we will repair or replace it at our cost. Please note that the decision to
repair or replace a device or device part will be at our discretion. Our warranty applies only if
the device is properly maintained by the original purchaser for normal, indoor use and does
not cover normal wear and tear, modification of the device, or damage caused by abuse,
improper use, failure to maintain, use which exceeds the published device limitations or the
combination of any device with another product. In addition, our warranty does not cover fading,
colorfastness, stains, spills or exposure to chemicals, odors, heat or light. In certain cases, we
may provide you repair or adjustment instructions and/or replacement parts, and ask you to
perform a repair or adjustment or replace a defective part.
Our warranty gives you specific legal rights, and you may also have other rights, which vary
from state to state. Please note that our limited warranty period begins when we ship the
device to you. The limited warranty period and our obligations under the warranty end once
you transfer the device to someone else or at the end of the applicable limited warranty period
identified below, whichever is earlier.
Warranty Period
(Parts Only)
Anticipated Usable
Device Life
Direct Supply®Zero Opening Assist Device 3 years 3 years
Anticipated Usable Device Life is based on normal use with proper maintenance, cleaning and
storage. You should still inspect, monitor and care for the device as described in this guide, as the
device may need to be replaced sooner than anticipated in particular situations.
DIRECT SUPPLY MANUFACTURING, INC. MAKES NO IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; THESE AND ALL OTHER
IMPLIED WARRANTIES ARE SPECIFICALLY DISCLAIMED. TO THE FULLEST EXTENT
ALLOWED BY LAW, DIRECT SUPPLY MANUFACTURING, INC. WILL NOT BE LIABLE FOR ANY
INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR LOST PROFITS THAT
MAY RESULT FROM THE DEVICE OR YOUR USE OF OR INABILITY TO USE THE DEVICE EVEN
IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. OUR TOTAL LIABILITY TO YOU, IF
ANY, IS LIMITED TO THE PRICE OF THE DEVICE OR SERVICE GIVING RISE TO YOUR CLAIM.
Some states do not allow an exclusion or limitation of incidental or consequential damages,
or how long an implied warranty lasts, so the above limitations or exclusions may not apply to
you. If implied warranties are not excluded, and to the extent allowed by law, we limit any and
all implied warranties to the applicable warranty period identified above. Except for rights under
any applicable state law, the remedies provided under this warranty are your sole and exclusive
remedy for any breach of our warranty and state the entire limit of our responsibilities.

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Our promise to you is that you will have a convenient and easy ordering experience, receive a
quality Zero Opening Assist and enjoy outrageous customer service. If you have any questions
about the zero opening assist you have purchased or would like to request warranty service,
please contact: Direct Supply Equipment & Furnishings at 1-800-634-7328, 7301 West
Champions Way, Milwaukee, WI 53223, [email protected].
Customer Service

Distributed by Direct Supply Manufacturing, Inc. 6635 West Champions Way, Milwaukee, WI 53223.
© 2020 Direct Supply Manufacturing, Inc. All Rights Reserved. Direct Supply®, Panacea®, and all associated logos are the registered
trademarks of Direct Supply, Inc., used under license.
15311Date of Printing: August 2020