Posey Bed 8060 User Manual

User Manual
8060
U.S. Pat. No. 7,047,991 & 7,383,849
Rx ONLY
Posey Company • 5635 Peck Road, Arcadia, CA 91006-0020 USA Phone: 1.800.447.6739 or 1.626.443.3143 • Fax: 1.800.767.3933 or 1.626.443.5014 • www.posey.com
How to Use this Manual
Introduction
Symbols
Definitions
In addition to this manual, you should also review:
• The Assembly Instructions
• The In-Service Training Manual
The symbols below are used throughout this manual and should be carefully read.
A Warning alerts you to a safety hazard or unsafe practice, which, if not avoided, could result in serious injury or death.
A Caution alerts you to a hazard, which, if not avoided, may result in minor or moderate injury to you or the patient, or damage to the Posey Bed 8060.
NOTE
A Note provides helpful information to make bed use easier and more efficient.
The following words have special meaning when used in this Manual:
BIOHAZARDOUS – matter that is contaminated with human blood; tissues; certain body fluids. Check with the patient’s doctor if you have any questions about this hazard.
CARE PLAN – the patient’s Individualized Care Plan (ICP) as written by the IDHT (see below).
INTERDISCIPLINARY HEALTHCARE TEAM (IDHT) – writes the Care Plan and supervises patient
care. The team may include, among others, Doctors, Nurses, Occupational Therapy, Physical Therapy and Social Services.
ENTRAPMENT – an event in which a patient is caught, trapped, or entangled in a confined space. This can result in serious injury or death from suffocation, compressions, or lack of proper blood flow.
Need help?
If you need help or have any questions, please call Posey Customer Support at 1.800.447.6739 between 6:00 am PST, and 5:00 pm PST. You can also contact your authorized bed dealer.
2 Posey Bed 8060
Table of Contents
Topic See Page
Welcome to the Posey Bed 8060 ......................................................................................................................... 4
About the Posey Bed 8060 .......................................................................................................................................5
When the Bed Should Not Be Used (Contraindications) .......................................................................6
A Special Note .................................................................................................................................................................7
Patient Reassessment .................................................................................................................................................8
Description of the Posey Bed 8060 ....................................................................................................................9
Parts of the Posey Bed 8060 System ................................................................................................................. 9
Choosing the Right Bed for use with the Posey Bed 8060 .............................................................10-11
Warnings and Precautions ................................................................................................................................12-14
Basic Bed Operation .............................................................................................................................................15-18
Install or Replace Mattress ............................................................................................................................15
Zip and Unzip the Access Panels ..........................................................................................................16-17
Use the Tube and Drainage Ports ...............................................................................................................18
Before First Time Use .........................................................................................................................................19-20
Check for Proper Bed Assembly .................................................................................................................19
Guidelines for Proper Bed Location ........................................................................................................20
Guidelines for Training ...................................................................................................................................20
New Patient Selection and Monitoring ..........................................................................................................21
Emergency Patient Access and Exit ..................................................................................................................22
Regular Daily Patient Care ...............................................................................................................................23-27
Moving the Patient Into the Bed ............................................................................................................... 24
Access and Care for the Patient in the Bed ......................................................................................... 25
Moving the Patient Out of the Bed .........................................................................................................26
A Special Considerations for Home Care Enviroments ................................................................. 27-28
Quick-Check 10 ............................................................................................................................................................29
When Not to Use the Posey Bed ................................................................................................................... 30-31
Quick Clean the Posey Bed 8060 .......................................................................................................................32
Separate Mattress Compartment from Patient Compartment ...................................................... 32
Machine Washing the Posey Bed 8060 .......................................................................................................... 33
Posey Accessories ....................................................................................................................................................... 34
Troubleshooting and Frequently Asked Questions ................................................................................ 35
Posey Limited Warranty ......................................................................................................................................... 36
Posey Technical Service ..........................................................................................................................................36
Posey Bed 8060 3
Welcome to the Posey Bed 8060
Introduction
Prescription Only and Required Training
Benefits
Risks
The Posey Bed 8060 is an A-Frame canopy system. When attached to a compatible hospital bed (not included), the 8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit.
Because the Posey Bed 8060 is a restraint, its use must be prescribed by a licensed doctor. Anyone caring for a patient in the Posey Bed 8060 must be trained.
The Posey Bed 8060 was designed to help provide these benefits:
• A controlled patient environment,
• Reduce the risk of unassisted bed exit,
• Reduce the risk of patient falls,
• Avoid the risk of a patient being trapped under a mattress, and
• Eliminate the need for side rails when the patient is alone. This avoids the risk of the patient being trapped in the side rails, or between the mattress and side rails.
Improper use of the Posey Bed 8060 may lead to serious injury or death. Patient monitoring should be determined by hospital protocol, a doctor, and the patient’s care plan. As with any less restrictive restraint system, it is important to understand when the Posey Bed 8060 is needed, when it should not be used, and the dangers related to entrapment, suffocation, choking, and falls.
4 Posey Bed 8060
About the Posey Bed 8060
Indications for Use
(When the Posey Bed 8060 can be used)
Bed Use
Patients Who May Benefit
The Posey Bed 8060 is an A-Frame canopy system. When attached to compatible hospital bed (not included) the 8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit. The Posey Bed 8060 is a less restrictive alternative to physical restraints such as belts, vests, or jackets for patients at least 46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8060 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.
The Posey Bed 8060 must follow:
• All state regulations,
• Federal Center for Medicare & Medicaid Services (CMS) Regulations,
• The patient’s care plan (check with the doctor if you have any questions about whether a patient’s care plan is needed to help meet any special needs (if applicable) of the patient,
• The policies of your facility (if applicable).
Patients who may benefit from the use of the Posey Bed 8060 include patients who are at extreme risk for a fall and/or unassisted bed exit including those with:
• Severe osteoporosis, (brittle, fragile bones),
• Severe risk of broken bones due to clinical conditions,
• Lack of muscle, fat, and subcutaneous tissue to absorb the impact of a fall,
• Use of blood thinners,
• A history of falls in the past,
• Conditions that cause uncontrollable movement such as Huntington’s Disease.
Clinical Conditions
Falls
1
Dementia patients are at increased risk of falls. This may be due to impaired judgment, altered gait, and/or sensory deficits. Ellelt, Anne “Keeping Dementia Residents Safe” Assisted Living Consult, Sept/Oct 2007, page 20.
2
Hitcho, Eileen B. et al., “Characteristics and Circumstances of Falls in a Hospital Setting” JGIM, Volume 19, July 2004.
Certain patients at-risk for a serious injury from a fall may also benefit from the use of the Posey Bed 8060. This includes patients with behavioral, physical, mental or other symptoms identified by the IDHT such as:
• Musculoskeletal problems that cause an unsteady gait or impaired strength or biomechanics,
• Altered awareness due to medication or neural illnesses or conditions that impair alertness and balance, and/or dementing illnesses,
• Visual or peripheral numbness or weakness that impair positional sense.
Most falls occur in Neurology and Medical units, with the highest rate in Oncology units. Fall rates may be higher in units with higher patient to nurse ratios.
1
2
Posey Bed 8060 5
When the Bed Should Not be Used (Contraindications)
When Not to Use the Device
Possible Adverse Reactions
It is important to note that Posey Bed 8060 is not suitable for every patient because every patient’s diagnoses, or activity level are different, the Posey Bed 8060 is not suitable for every patient.
The Posey Bed 8060 is not intended for use with:
• Patients who weigh less than 46 pounds, or are shorter than 46 inches. – These patients are at risk of serious injury or death, and the Posey Bed 8060 has not been tested for use by such patients.
• Patients who weigh more than 300 pounds.
– This is the maximum load capacity of the Posey Bed 8060 canopy.
• Patients diagnosed with any condition that may cause violent or self-destructive behaviors.
– These could result in self-injury and/or damage to the Posey Bed 8060. – Violent moving of the body from side to side could cause the Posey Bed 8060 to tip over or move to a position where the patient is injured by contact with an object in the room. – Patients who rub excessively.
• Patients with an excessive Pica eating disorder.
– This refers to a person who may attempt to eat the canopy or padding of the Posey Bed 8060. – Patients who suffer from this disorder include adults, and it is the most common eating disorder among children who are developmentally disabled.
• Patients who are, or who become, claustrophobic while in the Posey Bed 8060.
Although it is a less restrictive restraint, the use of the Posey Bed 8060 could cause emotional, psychological, or physical problems in certain patients. These include:
• A significant change in mental status, such as claustrophobia or depression,
• Sudden mood changes which lead to a change in medical conditions,
• An increase in aggression or self-destructive behaviors.
Get help from the doctor or the IDHT if these symptoms appear and do not improve as the patient becomes used to the Posey Bed 8060. You may need to find a different method of treatment.
6 Posey Bed 8060
A Special Note
Background
At-Risk Patients
Reducing the Risk of Entrapment
All hospital beds pose safety and entrapment risks. The U.S. Food and Drug Administration (FDA) received approximately 803 entrapment reports in the U.S. for standard hospital beds over a period of 24 years from January 1, 1985 to January 1, 2009.
The FDA formed the Hospital Bed Safety Workgroup (HBSW) to develop solutions to reduce the risk of patient entrapment in hospital beds. The HBSW issued guidelines in 2006 describing seven potential zones of entrapment and recommendations to reduce life-threatening entrapments associated with hospital bed systems.
The Posey Bed 8060 was designed to help eliminate each of the seven entrapment zones when the canopy is used with a compatible hospital bed at the lowest acceptable height (16 or 17 inches from the floor to the deck of the bed) when the head of the bed is down and the mattress is flat.
• Patients who, because of mental or physical disability, cannot reposition or remove him or herself from a confined area in the bed.
• Any other patient identified by the doctor, the care plan, or Interdisciplinary Healthcare Team (IDHT) to be at risk of entrapment in the gaps created when the head of the Posey Bed 8060 is up.
To help reduce the risk of entrapment, do the following:
• Keep the mattress flat. – If you need to elevate the head or body of an at-risk patient, while the patient is alone, keep the mattress flat and use a Posey Torso Cushion (Cat. 8025) to position the patient. – If you must leave the head of the bed up for an at-risk patient (for example, while watching TV or if called for by the doctor’s order, or the patient’s care plan, use the Posey Filler Cushions (Cat. 8021) and provide extra monitoring.
• Provide extra monitoring. – Monitor patient per facility’s restraint protocol to ensure that the Posey Filler Cushions cannot be removed by an at-risk patient and that an at-risk patient cannot crawl under or around the Posey Filler Cushions.
• Avoid stretching the canopy material. – The canopy may stretch over time during normal use, or due to patients who try to escape. This could result in pocket areas on the inside of the canopy. Regular washing and drying should help reduce this condition. DO NOT use any canopy that has tears or damage and request a replacement.
4
3
Alternative Method of Treatment
3
This report can be found at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164366.htm
4
Guidance for Industry and FDA Staff – Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. March 10, 2006). This report can be found at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072662.htm
If necessary, consult the doctor or the IDHT to find a different method of treatment for any at-risk patient.
Posey Bed 8060 7
Patient Reassessment
If the patient’s physical or mental health changes, check with the doctor to make sure the Posey Bed 8060 is still a safe enviroment. Use the Posey Bed 8060 only if there is not a less restrictive alternative. ALWAYS use the least restrictive device available for the shortest time while you seek a less restrictive option.
Alternatives to Restraint Use
Review the patient’s mental and physical status often to be sure that the benefits of using the Posey Bed 8060 as a restraint outweigh the risks.
Safe use requires that:
• You define and remove, if possible, the cause of the symptoms that require a restraint. This may include catering to individual needs and routines; increased rehabilitation; restorative nursing; changing the environment; or increased supervision.
• You tailor interventions to the individual needs of the patient after weighing factors such as the patient’s condition; behaviors; history; and environment.
When possible, seek guidance from the patient’s family. Depending on the patient’s condition, alternatives to restraints may include one or more of these:
• A bedside companion,
• Fall alarms,
• Floor cushions,
• Lowering the volume on the TV,
• Adjusting window shades or dimming lights,
• Soft music, or
• Use of a Posey Activity Apron (Posey catalog 7400)
As with all restraints, the Posey Bed 8060 should NEVER be used for nursing convenience.
8 Posey Bed 8060
Description of the Posey Bed 8060
Bed Features and Benefits
• 6 INCH (15 CM) ENCLOSED MATTRESS COMPARTMENT
Helps avoid the risk of a patient being trapped under the mattress. The mattress compartment
can be expanded to ten inches (25 cm) to fit a ten inch (25 cm) air type mattress.
• NYLON CANOPY SYSTEM
An A-frame green canopy surrounds the bed. The nylon is biocompatible. The canopy has four
(4) access panels for easy access to the patient, and multiple ports for intravenous lines, the Nurse Call Button, or drainage line. Zippers are secured with Quick-Release Buckles.
Parts of the Posey Bed 8060 System
1. ENCLOSED EXPANDABLE MATTRESS COMPARTMENT. Designed to fit a 6 inch (15 cm) mattress or a ten inch (25 cm) air
mattress.
2. NYLON CANOPY. The nylon material is water-repellent.
3. A-FRAME. A sturdy “A” shaped metal frame supports the Nylon Canopy.
4. TWO “U” SIDE PANELS. One (1) panel on each side with a single zipper on each panel for easy patient access.
5. HEAD (5A) AND FOOT (5B) ACCESS PANELS. Helps provide easy access to the head and foot of the bed with a single
zipper on each panel.
6. QUICK-RELEASE BUCKLES. Clipped to zipper pull-tabs for added patient security.
7. FOAM CANOPY PADS. Six (6) pads fit around the canopy frame to help reduce the risk of injury from contact with the frame.
8. TUBE PORTS. Eight (8) ports, two on each of the four sides of the canopy to run tubes into the patient compartment.
9. DRAINAGE PORTS. Two (2) ports, one on each side of the “U” Side Panels.
10. IV POST MOUNT BRACKETS. Four (4) brackets, two on each side of the “A–Frame”, to firmly attach the frame to the IV socket on the hospital bed.
11. POSEY BED INSTRUCTION STORAGE POCKET. Stores all product Manuals and the “Quick-Check 10” for easy reference.
5a. Head
Access Panel
4. Nylon “U” Side Panel
3. A-Frame
2. Nylon Canopy
1. Mattress
Compartment
6. Quick-Release Buckle
11. Instruction
Storage Pocket
7. Foam
Padding
8. Side Panel
Tube Port
5b. Foot
Access
Panel
9. Drainage Port
10. IV Post
Mount Bracket
Posey Bed 8060 9
Choosing the Right Bed for use with the Posey Bed 8060
Compatible Hospital Beds
The Posey Bed 8060 is an A-Frame canopy that attaches to a compatible hospital bed. Because the canopy does not include a bed, it is very important to choose the correct hospital bed for proper and safe use. Using the wrong bed may result in serious injury or death to the patient. There are a number of hospital beds in use today, from many manufacturers, which are fully compatible with the Posey Bed 8060. Hospital beds come with either removable head and footboards, or non­removable head and footboards.
Compatible hospital beds must meet the following requirements:
• Length of bed frame must be ≤ 96” and does not retract < 76”
• Width of bed frame must be ≤ 36”
• The height of the bed platform (deck of the bed) from the floor must be able to adjust between 16 and 25 inches.
Depending on the features of the bed, operational limits must also be observed when a Posey Bed canopy is in use as described in the User Manual. For example, the head of bed angle can only be raised to ≤ 70°.
It is important to keep the bed platform in the lowest position to keep the canopy tight and avoid excess material in the patient area when the patient is alone.
NEVER use any of the features listed below while using the Posey Bed 8060 canopy:
NEVER lower the deck of the bed below sixteen inches (16”) from the floor to prevent suspending the mattress above the bed deck. The bottom of the canopy must be fully supported by the bed deck to prevent canopy damage; or
NEVER raise the hospital bed above twenty five inches (25”) from the floor to the deck of the bed; or
NEVER tilt the hospital bed surface head-to-foot or foot-to­ head (Trendelenburg feature); or
NEVER allow the hospital bed to transform into a “chair” shaped position, where the foot of the bed can be lowered to an angle greater than five degrees (5°).
Using these features will damage the canopy system and bed motors and will increase the risk of serious injury or death from entrapment, suffocation from excess material in the patient compartment, or from an unassisted bed exit, which could result in a fall.
Deck of Bed
16” - 25”
Deck of bed
16” or 17”
Fitting the Posey Bed 8060 through doorways
Beds with removable head and footboards
Beds with non­removable head and footboards
The Posey Bed 8060 may not always fit through doorways. In this situation, lower the top piece to the lowest position, push the silver metal detent pin into the bottom hole, then return it back to the top hole after transport.
ALWAYS put the top rail back into the higher position, with the silver metal detent pin in the top hole, to keep the canopy taut and avoid excess material in the patient compartment, which could pose an entrapment risk.
ALWAYS use the IV Post Mount Brackets (comes standard with the Posey Bed 8060) on a hospital bed with removable head and footboards. Mounting the IV Post Mount Bracket to the IV Post Socket will firmly attach the A-Frame to the bed.
ALWAYS use the Posey Bed Universal Straps (Cat. 8018, sold separately) for a hospital bed with non-removable head and footboards to firmly attach the frame to the bed. NEVER attach the Universal Straps to a bed with removable head and footboards. Doing so will cause the A-Frame to detach from the hospital bed when the bed is raised, and may result in serious injury or death from a fall or unassisted bed exit. ALWAYS use Posey Bed Headboard/Footboard Pads (Cat. 8002, Sold separately) to cover the head and footboards to help prevent injury from direct contact with solid head and footboards. Failure to do so may result in serious patient injury.
Bottom Hole
Corner
Pads
Top Hole
10 Posey Bed 8060
Choosing the Right Bed for use with the Posey Bed 8060 (Continued)
NEVER use the Posey Bed 8060 with:
Incompatible Beds
• Residential-type beds. The canopy system of the Posey Bed 8060 is not designed to securely attach to residential-type beds. A failure to heed this warning may result in serious injury or death from entrapment or suffocation, or from a fall or unassisted bed exit;
• Any hospital bed which cannot be lowered between sixteen (16”) and seventeen (17”) inches from the deck of the bed to the floor. It is necessary to lower the bed to at least seventeen to keep the canopy tight and avoid a “blousing” effect and excess material in the patient compartment, which will increase the risk of entrapment or suffocation;
• Any hospital bed that allows the head to be raised to an angle greater than seventy degrees (> 70°). Raising the head to a greater angle will damage the canopy and increase the risk of serious injury or death from a fall or unassisted bed exit; or
• Any hospital bed that does not securely attach to the Posey Bed 8060 with either (1) the four IV Post Mount Brackets or (2) the Posey Bed Universal Straps; as this may result in serious patient injury.
NEVER allow patient weight to exceed the maximum load of 300 lbs.
Allen Head Screws
Entrapment Risk (All Patients) - Use of Side Rails
Entrapment Risk
The Allen Head Screws on the bottom center piece of the Posey Bed 8060 must be secure, but loose enough so the A-Frame slides freely when raising or lowering the head or foot of the hospital bed. A failure to follow this warning may interfere with proper operation of the hospital bed.
NEVER leave side rails in the up position when the patient compartment is closed. A failure to follow this warning may result in serious injury or death from entrapment in the side rails, or between the mattress and the side rails. The risk of entrapment is even greater when the head of the bed is raised. These zones pose an extreme risk of serious injury or death from entrapment. An agitated or aggressive patient is also at risk of injury from contacting the side rails when they are in the UP position.
To help reduce the risk of entrapment, ALWAY S put side rails down when leaving a patient alone to reduce the risk of entrapment and serious patient injury or death. Side rails should ONLY be used as an aid to assist a patient in or out of bed, or to help prevent a patient fall while providing bedside care.
ALWAYS lower the bed deck to 16”-17” (41 - 43 cm) from the floor and make sure the top rail is in the highest position before leaving the patient alone. This will keep the canopy tight and help prevent gaps or folds.
Bottom Center Piece
Allen Head Screws
ALWAYS put the top rail back into the higher position, with the silver metal detent pin in the top hole, to keep the canopy taut and avoid excess material in the patient compartment, which could pose an entrapment risk.
Corner
Pads
Top Hole
Bottom Hole
Posey Bed 8060 11
Warnings and Precautions
Canopy Gaps
Risks Associated with Suffocation or Choking
Risk of Fall or Unassisted Bed Exit
Violent or Aggressive Patients
Filler Cushions
Entrapment
Entrapment risk for certain at-risk patients include canopy gaps. Raising the head of the Posey Bed 8060 will create “gaps” or “pockets” between the head of the bed and the canopy. These areas can cause extreme risk of serious injury or death from entrapment to certain at-risk patients. Keep the mattress flat with the head of the bed down, when an at-risk patient is alone. Use Posey Filler Cushions (Cat. 8021) if an at-risk patient’s head or body must be elevated (for example, while watching TV, or if called for by the doctor’s order or the patient’s care plan). In this case, provide extra monitoring per the facility’s restraint protocol to ensure that the Posey Filler Cushions (Cat. 8021) cannot be removed by an at-risk patient and that an at-risk patient cannot crawl under or around the Posey Filler Cushions. If filler cushions are not available, lower the bed to the flat position and use a Posey Torso Cushion (Cat. 8025).
To help reduce the risk of suffocation, do the following:
NEVER put a mattress inside the patient area,
ALWAYS keep the mattress in the mattress compartment, completely zipped,
• Keep tubes or monitoring lines and the Nurse Call Button inside the bed only if allowed by the care plan.
NEVER use the Posey Bed 8060 if there is damage to the canopy, access panels or zippers. A failure to follow this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall. ALWAYS check the canopy and the zippers before leaving the patient alone to help reduce the risk of a fall or unassisted bed exit. (See page 14)
NEVER leave a patient alone if the zippers do not close completely, there are holes in the canopy or netting, the foam padding covering the metal frame is damaged or missing, or the frame is damaged. (See page 30)
NEVER leave a patient in the Posey Bed 8060 if they have a risk of self-injury; injury to others; the bed tipping over; or if the patient tries to damage the bed.
• Be aware that a sudden mood swing may cause violent or aggressive behavior. Follow your facility’s security policy, the care plan or the doctor’s orders for such patients.
• A patient who may become violent or aggressive may require constant monitoring or different methods of restraint.
• No level of monitoring may avoid risk of serious injury to certain violent or aggressive patients, i.e. patients who flail from side to side attempting to tip over the bed or injure themselves against the frame.
• Use of the Posey Bed 8060 by an agitated patient or a patient who tries to escape must be approved by the doctor or the IDHT when tube(s) or line(s) are in use. There is a risk of serious injury or death if the patient becomes caught up, or disrupts the integrity of a tube or monitoring line.
• Watch for signs of claustrophobia, or a significant increase in stress or physical movement. Remove these patients from the Posey Bed 8060 immediately and notify the doctor. You may need to find a different method of treatment.
Torso
Cushion
12 Posey Bed 8060
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