Direct Supply Panacea 6300, Panacea 6300 3-Function, Panacea 6300 5-Function Owner's Manual

Panacea

6300 Bariatric Bed

For Panacea 6300 3-Function and Panacea 6300 5-Function beds

Owner’s Manual

Please keep and refer to this Owner’s Manual.

Thank you for purchasing a Panacea® 6300 Bariatric Bed from Direct Supply® Equipment & Furnishings™. Please read this entire guide carefully and keep it for future reference. This guide will provide you with instructions, warnings, warranty information and other important information about your Panacea bed. Share this information with your housekeeping, nursing and maintenance staff to help ensure the bed is cared for properly.

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Table of Contents

Introduction .....................................................................................................................................3

Definitions and Symbols ..................................................................................................................3

Device Description ..........................................................................................................................3

Warnings ....................................................................................................................................4-11

Mattress Specifications ................................................................................................................. 12

Environmental and

Electrical Specifications ................................................................................................................. 13

Directions for Use .........................................................................................................................14

Mattress Retainer Adjustment ...................................................................................................... 15

Headboard and Footboard

Installation and Adjustment ........................................................................................................... 16

Assist Device Assembly ................................................................................................................ 17

3-Position Assist Device ................................................................................................................ 18

Width Extension ............................................................................................................................ 19

Wall Guard ..................................................................................................................................... 20

Bed Functions ...............................................................................................................................21

Bed Mobilization

and Stabilization .............................................................................................................................22

Battery Backup ......................................................................................................................... 23-24

Care and Maintenance .............................................................................................................25-26

Servicing ................................................................................................................................... 27-28

End of Life Disposal ......................................................................................................................29

Troubleshooting ........................................................................................................................ 30-31

Electromagnetic Emission

and Immunity ...........................................................................................................................32-33

Limited Warranty ........................................................................................................................... 34

Customer Service .......................................................................................................................... 35

Introduction

The Panacea® 6300 Bariatric Bed features quiet and smooth multiposition actuation with full battery backup for reliable operation. Its steel rib-style bed frame has heavy-duty, lockable casters for maneuverability. The push-button expandable deck adjusts the bed width from 37" to 39", 42" or 48" to accommodate any body type. The bed arrives fully assembled and IV pole ready; just attach assist devices, wall guard, and amber cherry headboards and footboards. Mattress retainers, wall guard and assist rails included – optional bariatric free-standing trapeze available.

Definitions and Symbols

NOTE: Indicates a helpful tip. CAUTION: Indicates correct operating or maintenance procedures in order to prevent damage to or

destruction of the equipment or other property. WARNING: Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury.

: Attention! Read the instructions. Device: Your Panacea 6300 Bariatric Bed. YOU and YOUR: The facility, community, or other person or entity that has purchased the product. WE, US and OUR: Direct Supply Manufacturing, Inc.

Device Description

Panacea bariatric beds are designed for bariatric residents. These beds are designed for use in clinics, hospitals and rehabilitation centers and for use in long-term healthcare centers. Beds are intended for adults with varying medical and physical conditions.

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Warnings

Read and follow all directions and warnings before using this device. Do not operate this device without ﬁrst reading and understanding this user manual. Damage or injury may result from improper use of this device. The information contained in this document is subject to change without notice.

WARNINGS

1. Failure to comply with all directions and warnings may result in injury or death; use only as directed.

2. This device is not suitable for all individuals. Other devices may be required.

3. Inspect the device for damage before each use, and do not use it if it appears to be damaged or not

functioning properly.

4. Never alter the device in any way.

5. This device is designed for indoor use only within close proximity to skilled caregivers.

6. This device is not designed to operate with residents and accessories weighing more than

750 lbs. combined.

WARNING: DO NOT use near explosive gases.

WARNING: Possible ﬁre hazard if used in conjunction with a nasal mask in ½ bed tent of oxygen- administering equipment. If O2 tent is being used, it should not fall below mattress deck. The pendant should not be placed in an oxygen-enriched environment, such as an O2 tent.

• Possible re hazard when used with oxygen-administering equipment other than nasal or masked type.

• When using nasal or masked type administering equipment, oxygen or air tubing MUST be routed

and secured properly to ensure tubing does not become entangled, kinked or severed during normal operation of the bed.

WARNING: This device includes assist devices. Some states may prohibit assist devices or consider assist devices to be resident restraints. Always assess whether restraints are necessary 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.

WARNING: To reduce the risk of electrocution:

1. Do not operate near water.

2. Do not allow any part of this device to be placed into or dropped into water or other liquid.

3. Do not reach for a device part that has fallen into water. Unplug immediately.

4. Do not remove control unit cover.

5. Always clean this device in a manner consistent with the cleaning instructions in this manual (see Care

and Maintenance section).

WARNING: To reduce the risk of burns, ﬁre or injury to persons:

1. Use this device only for its intended use, as described in the operating instructions.

2. Never operate this device if it has a damaged cord or plug, if it is not working properly, if it has been

dropped or damaged, or if it has dropped into water. Return the unit for examination and repair.

3. Keep the cord away from heated surfaces.

4. Never drop or insert any object into any opening or hose.

5. Do not use outdoors.

WARNING: This bed may require other equipment which may include, but is not limited to:

1. Bedrails for repositioning and fall prevention.

2. Resident monitoring devices for elopement prevention.

3. Other devices as speciﬁed by the caregiver.

WARNING

This device is only a tool as part of an overall care plan. Failure to comply with all instructions, warnings and precautions, or using the device for a purpose other than the recommended use, could result in bodily injury or death. This device is not designed to replace good caregiving practices, including, but not limited to:

• Direct patient and resident supervision.

• Adequate care plans and training for staff personnel for entrapment and fall prevention.

• Inspection and testing before use.

No part or component of a Panacea bed should be used with non-Panacea bed parts or components.

Possible entrapment hazard may occur if you do not use an appropriate mattress. Resident entrapment may lead to injury or death. You should consult with a healthcare professional to determine the appropriate mattress and accessories for the speciﬁc resident.

WARNING: Any cords or tubing used on or with this bed MUST be routed and secured properly to ensure they do not become entangled, kinked or severed during normal operation of the bed.

WARNING: Do not plug anything into housing components of bed (pendants or actuators) while power cord is plugged into the wall outlet.

WARNINGS – General

• When using liquids in or around the bed, caution should be taken to ensure liquids of any kind are not

spilled. If a liquid is spilled in or around the bed, UNPLUG the bed immediately. Clean up spill and allow bed and area around bed to dry thoroughly before using the electric controls again.

• After installation and before use, make sure all attaching hardware is securely tightened.

• Pendant cord must be routed and secured properly to ensure cord does not become entangled or

damaged during normal operation of the bed.

• Keep all moving parts free from obstruction, e.g., blankets/sheets, heating blankets/pads, tubing,

wiring, etc. which may get tangled around the bed, assist devices or legs during operation of the bed.

• Beds are equipped with locking casters. Casters should be locked at all times, except when moving the

bed or when operating subacute care features.

• The assist devices are not intended for and may NOT be used as a restraint. If necessary, a physician or

healthcare professional should be consulted for other means of safe restraint.

• When using assist devices, if excessive side pressure is exerted on them, they can be deformed or

broken. Do not use assist devices as handles to move the bed.

• Never permit more than one person in/on the bed at any time.

• Body weight should be evenly distributed over the surface of the bed. The bed weight capacity is 750

lbs. This is the total weight of the resident, mattress, bedding, headboard and footboard, assist devices, and any other accessories. Exceeding weight limit may cause bed to fail.

• Do not allow resident to lie, sit or lean in such a way that the entire body weight is placed only on

raised head or foot sections of the bed. This includes while assisting the resident in repositioning or transferring in or out of bed.

• The bed is provided with an additional safety feature of a protective earth ground to help protect against

possible shock hazard. The electrical cord should only be plugged into a grounded 110/120V outlet. DO

NOT ALTER THE PROVIDED PLUG. Do not, under any circumstances, cut or remove the grounding prong. If the plug does not ﬁt the existing outlet, a licensed electrician should install a correct outlet. Never operate the bed if it has a damaged cord or plug.

• Unplug the power cord when performing any maintenance on the bed.

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Warnings (cont.)

• Do not open any actuators, control boxes or pendants. Service is only to be performed by authorized

service personnel. If unauthorized service is performed on any components, the warranty is void.

• Never allow anyone under the bed at any time.

• Supervision is required when this device is operated by or near children or people with disabilities.

• Ensure the individual using this bed is properly positioned, particularly when the bed is being operated or

moved. Do not let any body parts protrude over the side or between parts, especially when the bed is being operated or moved.

• Possible injury may occur if bed is not kept in the lowest position, except when care is being provided.

Bed should be at lowest suitable height for entry and exit.

• Possible injury or death may occur due to pendant cord being a source for entangling resident.

Residents with decreased mental acuity should NOT have access to pendant.

• Possible injury or death may occur if the bed is pushed over abrupt thresholds while occupied. This

bed was not designed to transport residents. Do not roll the bed over any power or pendant controls.

CAUTION: This bed frame complies with EMC requirements of IEC 60601-1-2. Radio transmitting equipment, cell phones or similar electronic devices used in proximity of the bed may affect the bed’s performance.

Emergency Evacuation

• If your mattress has Velcro side bolsters, remove them.

• Push in extension buttons.

• Slide extensions in toward the center of the bed.

• Adjust mattress retainers inward.

• Perform this procedure on both sides of the bed.

• The bed is now at 37" wide and can be used to evacuate resident out of the facility.

WARNING: The device should ONLY be used to transport residents in the event of an emergency.

WARNING: Reducing the Risk of Entrapment

The Hospital Bed Safety Workgroup (HBSW) in partnership with the FDA has recognized potential entrapment zones in hospital bed systems and has developed dimensional guidance to reduce the risk of entrapment. The FDA considers the term “hospital bed system” to encompass the bed frame and its components, including the mattress, bed assist devices, headboards and footboards, and any accessories to the bed.

The entrapment zones involve the relationship of components controlled by the healthcare facility or individual user. Compliance to the dimensional guidelines for reducing the risk of entrapment is primarily the responsibility of the healthcare facility or the individual user. Anyone having any involvement with hospital bed systems should review and understand the FDA guidelines. These guidelines, titled “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment – Guidance for Industry and FDA Staff,” are available on the FDA website.

WARNING: Steps to Reduce the Risk of Fires

• Inspect all cords for damage including the power cord and hand pendant.

• Connect the power cord directly into a wall-mounted outlet that is in good working order, with no

cracks or chips. The plug should ﬁt tightly into the outlet. The ground pin should be intact and secure.

• Do not use power strips, extension cords or multiple-outlet strips. Connect directly to a grounded wall-

mounted outlet.

• Do not cover any power cord with rugs, linens, cloths or other products that may cause heat to

build up. Heat may build up or the cord may be damaged.

• Check surrounding equipment for signs of excessive heat or physical damage.

• Inspect the oor beneath the bed for buildup of dust and lint. Ask housekeeping to clean, if necessary.

• Inspect the resident’s bed controls, looking for signs of damage where liquids could leak in.

• Test the bed and its controls, including resident lockout features, to ensure the bed can move freely in

both directions without damaging any cords.

• Keep linens and clothes away from power sources.

• Tell maintenance staff about any unusual sounds, burning odors or unusual movement of bed.

• If you suspect overheating, follow your facility’s policy for re safety and move the resident to a safe

area, if necessary.

Warning Labels

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Warnings (cont.)

NOTE: Information that appears under the NOTE text gives added information, which helps in understanding the item being described.

Product Symbols

Symbol Description Symbol Description

According to IEC 60417-5840. Type B applied part equipment

According to IEC 60529. Rating for dust protection and identiﬁed as equipment that is protected against splashing water.

According to ISO 7000-1641. Operating instructions

Recycle the item in accordance with local regulations.

Intertek’s ETL listed mark for U.S. and Canada. A product bearing the ETL listed mark is determined to have met the minimum requirements of prescribed product safety standards.

CE mark

Change head deck position

Change thigh/foot deck position

Change Auto Contour position

Change hi-lo position of mattress support platform

Change Reverse Trendelenburg angle

Change Trendelenburg angle

Safe working load Up

Maximum patient weight

Warning symbol Class II equipment

Danger: electricity, electrical hazard symbol

Warning: crushing of hands Warning: crushing of feet

Down

Flammable material symbol

Intended Use

The Panacea 6300 Bariatric Bed is intended for use within an institutional healthcare environment, Application Environment 3 (i.e. Skilled Nursing, Transitional Care, Rehabilitation Care, Assisted Living).

Compliance with the regulations and guidelines as speciﬁed by your facility is recommended.

This bed is NOT intended for patient/resident transport. Wheels are provided only to allow movement within the patient/resident room for cleaning or patient/resident access.

Contraindications

This bed should not be used by persons who do not have the cognitive skills to understand the information in the owner’s manual, operate the bed or control the movements of the bed through the control interfaces. This bed should not be used or operated by children.

General Safety

NOTE: In this manual, the terms patient and resident refer to a resident of a Nursing Home, Long Term

Care, Assisted Living or Rehabilitation facility.

Danger

• NEVER allow anyone under the bed at any time.

• DO NOT let any body parts protrude over the side or between parts, especially when the bed is

being operated.

Danger Shock Hazard

• DO NOT plug anything into the control box of bed (i.e. pendants and actuators) while mains cable

(power cord) is plugged into the wall outlet.

• Any cords or tubing used on or with this bed MUST be routed and secured properly to ensure they do

NOT become entangled, kinked or severed during normal operation of the bed.

• DO NOT roll the bed over any power or pendant cords.

• This bed is equipped with a three-prong grounding plug for protection against possible shock hazard.

DO NOT, under any circumstances, cut or remove the grounding prong.

• DO NOT open any actuators, control boxes or pendants. Service is only to be performed by authorized

service personnel. If unauthorized service is performed on any components, the warranty is void.

• Inappropriate handling of power supply cords can create a shock hazard.

• When routing cables from other equipment in the medical bed, precautions shall be taken to avoid

squeezing those between parts of the medical bed.

• DO NOT use an extension cord.

• DO NOT allow the cord, electrical outlets, and electrical control box or hand pendant to become

wet or submerged.

• DO NOT operate the bed if any electrical component, such as the power cord, electrical outlet,

connections, motor/actuator or mechanical component, has malfunctioned or has been damaged

in any way.

• To avoid risk of electric shock, this equipment must only be connected to a supply mains with

protective earth.

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Warnings (cont.)

Fire Hazard

• DO NOT use near open ame or explosive gases.

• Possible re hazard if used with nasal mask in ½ bed tent of oxygen-administering equipment. If O2

tent is being used, it should not fall below the mattress deck. The pendant should not be placed in an oxygen-enriched environment, such as an O2 tent.

• This bed should not be placed in an oxygen-enriched environment.

WARNING

• DO NOT operate this product without rst reading and understanding this user manual. Damage or

injury may result from improper use of this product.

• Possible injury or death may occur if accessories are not provided by Panacea. Please contact Direct

Supply Equipment & Furnishings for accessories that are compatible with this bed.

• Possible injury or death may occur if replacement/service parts are not provided by Direct Supply

Equipment & Furnishings. Please contact Direct Supply Equipment & Furnishings for replacement parts compatible with this bed.

• Possible injury or death may occur due to pendant cord being a source for entangling patient/resident.

Patients/residents with decreased mental acuity should NOT have access to pendant.

• Unplug bed or stop pressing pendant button when bed does not function as expected.

• NEVER permit more than one (1) person in/on the bed at any time. NEVER exceed the weight capacity

of this bed. The weight capacity of this bed is 750 lbs. (340kg) including accessories and options (not all accessories and options can be used at the same time).

Assumes: Max Patient/Resident Weight 582 lbs. (264kg)

Assist Rail (pair) 35 lbs. (16kg) Assist Rail (4) 70 lbs. (32kg)

Headboard/Footboard 41 lbs. (18.5kg)

Pendant 1.1 lbs. (0.5kg) Mattress Weight 55 lbs. (25kg)

• The medical bed should be left in its lowest position, except when care is being provided, in order to

reduce risk of injury due to falls.

• The bed MUST be connected to an appropriate power source. Unless equipped with the optional

battery backup, this bed will not operate when not plugged in. Mains cable and proper function must be checked regularly.

• Possible injury or death may occur if bed is pushed over abrupt thresholds while bed is occupied. This

bed is not intended for patient/resident transport. Please use an approved resident transport

device when moving a resident.

CAUTION

• This medical bed is not intended to work with patient lifts other than those specied by Direct Supply

Equipment & Furnishings as being compatible.

• DO NOT use assist rails as handles for moving the bed.

• Keep all moving parts, including the mattress deck (sleep surface), main frame, all drive actuators and

moving components, free of obstructions.

• Ensure the individual using this bed is properly positioned, particularly when the bed is being operated.

• Body weight should be evenly distributed over the sleeping surface of the bed. Avoid situations where

entire body weight is on a raised head or foot surface. This includes while assisting the resident in repositioning or transferring in or out of bed.

• Never allow anyone under the bed at any time.

• Supervision is required when this product is operated by or near children or people with disabilities.

• Do not let any limbs or body parts protrude over the side or between bed components, especially

when the bed is being moved or operated.

• Caster locks shall be used, except when bed is being moved. Bed is not intended for patient/

resident transport.

• Bed should be at lowest suitable height for entry and exit.

• Assembly of this bed and modications made during the actual service life require evaluation

to comply with the requirements of IEC 60601-1 and IEC 60601-2-52. No modiﬁcation of this equipment is allowed.

• Only items that have been specied as part of this bed or as being compatible with this bed shall be

connected to it.

• This bed frame complies with EMC requirements of IEC 60601-1-2. Radio transmitting equipment, cell

phones or similar electronic devices used in proximity of the bed may affect the beds performance.

Entrapment Warning

Accurate assessment of the resident and monitoring of correct maintenance and equipment use are required to prevent entrapment. For additional information on product and safety issues for bed frames and rails, refer to product manuals speciﬁc to the product or accessories you have or are planning to install. If bed frames have been serviced or any other adjustments have been made, you must ensure all parts are securely back in place before operating the bed. Other manufacturers’ assist rails may not be compatible and can lead to entrapment issues or harm to residents and staff. Make sure mattress is the correct size for bed frame and assist rails are secured to frame to decrease risk of entrapment.

On March 10, 2006, the U.S. Food and Drug Administration (FDA) released guidelines for reducing the risk of hospital bed entrapment, titled, “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.” This guidance document identiﬁes potential entrapment areas within the bed frame, rails and mattress and identiﬁes body parts most at risk for entrapment. It also provides

manufacturers with basic design criteria to consider when developing hospital/convalescent beds, recommends specic test methods to assess the conformance of existing hospital/convalescent bed

systems and answers frequently asked questions about entrapment issues. The FDA guidance document identiﬁes speciﬁc dimensional criteria on potentially injury-threatening

gaps and spaces that can occur between bed system components, such as assist devices when improperly installed. Panacea’s Long Term Care beds and approved accessories are manufactured to be in conformance with these guidelines.

Please be aware entrapment issues can still arise when components and accessories are not properly installed on the bed. It is important for the provider or facility staff to recognize they have an equal role in complying with the FDA guidelines to help ensure resident safety and avoid injuries.

Copies of this document can be obtained from the FDA website: http://www.fda.gov/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm072662.htm

Assist Rail Warning

Other manufacturers’ assist rails may not be compatible and can lead to entrapment issues or harm to

patients/residents. Only compatible assist rails may be used on this bed. Ensure mattress is the correct

size for bed frame and assist rails are secured to frame to decrease risk of entrapment.

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Direct Supply Panacea 6300, Panacea 6300 3-Function, Panacea 6300 5-Function Owner's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual