drive 14360-P Low Air Loss Mattress Replacement System User Manual

14360-P Low Air Loss Mattress Replacement System

USER MANUAL

Med-Aire Edge
Alternating Pressure & Low Air Loss
Mattress Replacement System

www.drivemedical.com
https://manual-hub.com/

This manual should be used for the initial set up of the system and for future reference.

DOCUMENT SYMBOLS

OPERATING INSTRUCTIONS
Indicates correct operating or maintenance procedure in order to prevent damage to or destruction of the equipment.
Note
Indicates tips or information users should be aware of.
Caution
Indicates a potentially hazardous situation which, if not avoided, could result in property damage or minor injury or both.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

IMPORTANT PRECAUTIONS

The Med Aire Edge System is a Class 2 medical device and that must be installed and operated in the manner for which it was intended. The user is responsible for reading and understanding the product user manual. Drive DeVilbiss Healthcare is not responsible for any injuries resulting from failure to comply with the instructions and precautions in this manual.
Danger
Do not use in the presence of flammable anesthetics. Do not use in the presence of smoking materials or open flames. Air flowing through the mattress will support combustion.
Danger
To reduce the risk of electrocution, adhere to the following instructions. Failure to do so could result in personal injury or equipment damage.

• Immediately after using the Med Aire Edge System, unplug this product from its power source.
• Do not place or store product where it can fall or be pulled into a tub or sink.
• Do not place in or drop into water or other liquids.
• Do not open the control unit without referring to Drive DeVilbiss technical service department first.

Warning
Do not strap the mattress to the bed frame at the head and foot ends. Secure mattress straps to the bed deck at the head and foot ends and to the bed frame at the center of the bed.
Warning
To reduce the risk of burns, electrocution, fire, or injury, adhere to the following instructions. Failure to do so could result in personal injury or equipment damage.

• This product should only be used for its intended purpose as described in this manual.
• Only use attachments and /or accessories that are recommended by the manufacturer.
• Do not use this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped, damaged, or immersed in water. Return to your provider for a warranty claim..
• Keep the cord away from heated surfaces, i.e. heat spacers.
• Never block the air openings of the product or place it on a soft surface, such as a bed or couch, where the air openings may be blocked. Keep the air openings free of debris such as lint and hair.
• Never drop or insert any object into any opening or hose.
• Do not use outdoors or operate where aerosol (spray) products are used.
• Connect this product to a properly grounded outlet only.
• Do not spill food or liquids onto the control unit. If a spillage does occur, turn off the unit, disconnect it from its power supply and allow at least 24 hours for drying.

Warning
Drive DeVilbiss Healthcare support surfaces are designed as mattress replacement systems. The risk of entrapment may occur when mattresses are placed on bed frames that do not properly fit and leave gaps between the mattress and head panel, foot panel and bed or side rails. This system is NOT to be used when such gaps are present.
User/Facility staff are responsible for ensuring that all mattresses properly fit the bed frames. Drive DeVilbiss is not responsible for the improper placement of its systems on ill-fitting bed frames. Health care professionals assigned to each patient should make the final determination whether side or assist rails are warranted after assessing patient risks based on the individual’s needs and condition.
An optimal bed system assessment should be conducted on each patient by a qualified clinician or medical provider to ensure maximum safety. The assessment should be conducted in compliance with the state and federal guidelines related to the uses of restraints and bed system entrapment guidance including but not limited to the below:

1. US FDA Entrapment Guidelines. “A Guide to Bed Safety,” https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/ucm123676.htm.
2. US FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Bed Entrapment, https://www.fda.gov/RegulatoryInformation/Guidances/ucm072662.htm.

INTRODUCTION

Pressure injuries are defined as localized injuries of the skin and/or underlying tissue over a bony prominence as a result of pressure or pressure in combination with shear.1 Support surfaces or specialized mattress systems are used as part of an overall, multi-disciplinary, multi-dimensional care plan intended to prevent and treat pressure injuries.
The Med Aire Edge Mattress Replacement System is a high quality powered air support surface that is specifically designed for the prevention and treatment of pressure injuries while optimizing patient comfort.
Indications for Use
Note
Effective pressure redistribution therapy, wound management and device selection should be based on the patient’s specific clinical condition and complete assessment of needs, recognizing that pressure prevention devices are only one component of a comprehensive pressure injury management program.
Support surfaces are not substitutes for turning, repositioning or functional weight shifts.
The Med Aire Edge system is intended for:

1. Pressure redistribution for individuals with but not limited to the following conditions:
   • At risk or present pressure injuries
   • Neurological conditions
   • Amputations
   • Grafts
   • Burns
   • Dermatological conditions
   • Flaps
   • Rehabilitation needs
   • Pain management as prescribed by a physician.

2. Shear & Friction Reduction
   Friction is defined as the resistance of motion in a parallel direction relative to the common boundary of two surfaces. For patients this can occur when the skin rubs against another surface.
   1 European Pressure Ulcer Advisory Panel and United States National Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guidelines. National Pressure Ulcer Advisory Panel; 2009.
   Shear strain occurs when tissue is deformed or damaged due to shear stress or force exerted parallel to the plane of interest. The Med Aire Edge’s cover is constructed of a smooth, stretch, polyurethane material with low shear and low friction properties to protect skin integrity.

3. Spinal Cord Injury
   The Med Aire Edge system can be used for patient’s with spinal cord injury once the acute injury has been stabilized and these patients have been assessed and cleared by the appropriate clinician.

Contraindications
Patient conditions for which the application of pressure relieving therapy on an alternation system is contraindicated are as follows:

1. Cervical or skeletal traction
2. Unstable spinal cord injuries

UNPACKING YOUR MED AIRE EDGE

1. Carefully remove all components from packaging.
2. Confirm that you have received the control unit intended.
3. Check all components for damages. Contact your medical provider if any components are damaged. DO NOT use damaged components.

PRODUCT FEATURES

The Med Aire Edge mattress replacement system is comprised of two components:

1. Therapy air cell mattress replacement with 360 degree foam perimeter
2. Therapy control unit

The Med Aire Edge control unit is available in two configurations:

1. Control Unit 14530P: Analog system
2. Control Unit 14360XP: Digital system

Control Unit 14530P (Figure 1)

• This analog control unit includes an easy to use pressure dial that is adjustable to the patient’s weight and comfort.
• Static button is available to discontinue alternation therapy for patient transfers, caregiving, comfort, or preference.
• Low pressure and normal pressure indicators allow the user to be aware of any air pressure changes with a corresponding mute button to silence.

Control Unit 14360XP (Figure 2)

• This digital control unit includes intuitive controls for adjusting the air pressure based on the patient’s weight and comfort levels.
• Static button is available to discontinue alternation therapy for patient transfers, caregiving, comfort, or preference.
• Low pressure, power failure and system failure indicators allow the user to be aware of any air pressure changes, power outages or system malfunctions, respectively.
• Mute button available for silencing information signal.
• Seat inflate increases air pressure for additional sacral support during head of bed (HOB) elevation.
• Cycle times are available to customize the therapy duration.
• Max firm is available for patient transfers or other patient care procedures.

Mattress
Warning
When using a therapy mattress system, always ensure that the patient is positioned properly within the confines of the bed. The patient’s head should be positioned in the center of the top section of the therapy mattress. Do not let any extremities protrude over the side or between the bed rails when the therapy mattress is being used.

• 20 individual air cells offer pressure redistribution and low air loss.
• Firm foam perimeter provides support during patient ingress and egress as well as providing power outage protection in the event of a power failure.
• Breathable, moisture vapor permeable fabric cover allows air to circulate beneath the patient and wicks away heat and moisture.
• Able to accommodate patients up to 450lbs.
• CPR valve available for rapid deflation (deflation time varies depending on patient weight and profile).

Note
Please be sure to read this manual in its entirety before attempting to set up and operate this system.

PRODUCT FUNCTION

Control Unit 14530P
Power switch is located on the side of the control unit. Use the power switch to turn the system off and on.

| Analog Pressure Dial
• Adjust the dial to correspond to the patients’ appropriate weight setting or comfort level.
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| Static Pressure switch
• Press the static pressure switch to discontinue alternating therapy.
| Mute button
• Silences the audible portion of the low pressure information signal.

Control Unit 14360XP
Power switch is located on the side of the control unit. Use the power switch to turn the system off and on.

| Power Button (1)
• Press the Power button on the panel, the pump will start/stop operation.
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| Cycle Time (2)
• The cycle time can be selected from the panel to choose the appropriate cycle time of the inflation modes.
• The cycle time value options are: 10, 15, 20, or 25 minutes.
| Weight Settings (3)
• Weight settings range from 80-450 lbs and can be used to adjust the pressure of the inflated cells based on the patient’s weight and comfort level.
| Mute Button(4)
• The audible/visible information signal turns on when low pressure, power failure or system failure occur.
• To mute the audible information signal, press the Mute button. The visible information signal indicator will continue flashing until the issue is resolved.
• Re-press the Mute button to reactivate the information signal.
| Alternate mode (5)
• Press to set the system to alternation therapy mode.
| Static mode (6)
• Press to set the system to static therapy mode. The system will revert to the previously set alternation mode after 120 minutes.
| Auto Firm (7)
• Press to set the air mattress to quick inflation mode, which facilitates nursing and caring.
The system will revert to the previously set therapy mode after 30 minutes.
| Seat Inflate (8)
• Press to set the air mattress to seat (fowler) mode. The pressure value will increase by 5mmHg to facilitate more comfortable seating.
| Lock button (9)
• Auto: control unit panel automatically locks in 5 minutes without operation.
• Manual: press lock button for 3 seconds to lock the panel, press again for 3 seconds to unlock the panel.

Mattress
The Med Aire Edge Mattress Replacement comes with a hose connection at the foot end of the mattress and 20 individual air cells encapsulated in a high- density foam shell. The cell material, polyurethane and nylon blend, provides a specialty surface that conforms to the specific shape of the patient, minimizing soft tissue distortion, reducing bone penetration into muscle fascia, and promoting improved blow flow compared to traditional surfaces.
CPRdeflationvalve
Pull the red CPR strap to release the air immediately from the mattress for rapid deflation. Deflation time varies depending on patient weight and profile.
Quick Connector
Used to connect the therapy mattress to the control units.

Warning
For important precautions, see pages three and four
Caution
Do not place the control unit on the floor. Position the power cord to prevent tripping hazards

1. Remove all existing covers, sheets and mattress from the bed.
2. Unpack the Med Aire Edge system and inspect all components for damage. Do NOT use the system if any component is damaged.
3. Confirm there are no sharp objects in the immediate area which may risk damage to the Mattress Replacement.
4. Position the Med Aire Edge Mattress Replacement on top of bed, printed top cover facing upwards and air hoses towards the foot end of the bed.
5. Secure the therapy mattress to the movable parts of the bed frame or bed deck. Ensure buckles are securely fastened and straps are pulled tightly.

DO NOT SECURE TO THE SIDE RAILS – STRAPS WILL TEAR OFF.

a) Position the control unit by hanging hooks over foot board of the bed.
b) Attach the air hoses to the therapy mattress securely using the quick connector. When properly installed, the quick connector will audibly click into place. Ensure air hoses do not kink between mattress, bed frame and control unit.
c) Plug the power cord into an electrical outlet with grounded AC power. Note
Before inserting the plug into the outlet, make sure the voltageis compatible and the product is well grounded.
d) Switch the power switch on the side of the control unit on. The mattress replacement system may take up to 40 minutes for full inflation regardless of the control unit being used. If using the digital control unit, press the AUTOFIRM button to speed up the process. The mattress system is fully inflated when the low pressure indicator goes out.

OPERATION

Note
Always read the operating instructions in this manual before use.
General
This product is designed to provide pressure redistribution while maximizing comfort to patients. Please be sure to operate this equipment as instructed to optimize its value. Please be sure to follow the instructions corresponding to the control unit being used.
Note
Please follow instructions below for detailed operating procedure of each type.
Operation using the 14530P (Analog Control Unit)
Step 1 Turn on the power switch located on the side of the control unit.
Step 2 The control unit will automatically default to a static mode of therapy and begin inflating to reach 30-60 mmHg. It may take up to 40 minutes to reach full inflation. If full inflation is not reached within 40 minutes, the low pressure information signal will illuminate.
Press the Mute button to mute the information signal. The information signal LED will continue flashing.
Press the Mute button again to re-enable the audible information signal.
Step 3 Press the static button to engage alternating therapy mode. Adjust the comfort knob to obtain the desired level of pressure to the patients’ specific requirements.
Note
For suitable pressure, please refer to page 14 for the hand check procedure.
Operation using the 14360XP (Digital Control Unit)
Step 1 Turn on the power switch located on the side of the control unit. Next press the power button on the front of the control power. A beep will sound to alert that the system is on.
Step 2 The control unit will automatically default to a static mode of therapy and begin inflating to reach 10-15mmHg. It may take up to 40 minutes to reach full inflation. If full inflation is not reached within 40 minutes, the low pressure information signal will illuminate.
Press the Mute button to mute the information signal. The information signal LED will continue flashing.
Press the Mute button again to re-enable the audible information signal.
Step 3 Press the Auto Firm button to automatically inflate the mattress to the maximum level (55mmHg) for about 20 minutes. The pressure will return to a previously set level after 20 minutes.
Step 4 Once fully inflated, the control unit will switch into alternating therapy mode at the default setting of 10 min and 30mmHg. Select desired settings from the touch panel to adjust the cycle time and pressure level to the patients’ specific requirements.
Note
Press the Autofirm mode button from the touch panel to provide a firm surface that makes it easier for the patient to transfer or reposition. The system will revert back to the previously selected therapy mode after 20 mins.
Note
During normal operation, the unit will monitor pressure. If the mattress pressure is lower than the set pressure, the pump will automatically inflate the mattress to readjust to the set level. The alarm will beep and its LED will come on to alert a low pressure condition.
Press the Mute button to mute the information signal. The information signal LED will continue flashing.
Press the Mute button again to re-enable the audible information signal.
Note
For suitable pressure, please refer to page 14 for the hand check procedure.
CPR function
When there is an emergency requirement to perform CPR on the patient, pull the CPR strap at the head section of the mattress to release the air quickly from the mattress.
Pressure range selection (+/-)
Users can adjust the pressure level of the air mattress, using the (+) and (-) buttons, to a desired firmness based on personal comfort or weight setting.
** Note
It is recommended to press Auto Firm on the panel when the mattress is first inflated. Users can then easily adjust the air mattress to a desired firmness according to the patient’s weight and comfort.
Low pressure indicator
When the air pressure in the system falls below the selected pressure range, a low pressure condition will signal the low pressure indicator. Check if the connections are secure and correctly installed according to the relevant instructions.
Note**
If the pressure is consistently low, open the zipper and confirm that all the hoses are properly connected.
Then check for any noticeable leakage in any of the tubes. If necessary, contact your local dealer to replace any damaged tubes or hoses.

PATIENT POSITIONING AND COMFORT

General Repositioning
Patients should be turned or repositioned based on their individually planned treatment schedule or per facility policy. Support surfaces are not substitutes for turning/repositioning or functional weight shifts.
Hand Check Procedure:
A suitable way to verify that the patient is not bottoming out is to perform a hand check as described below:

1. Ensure that the patient is lying supine (on his/her back) in the middle of the mattress.
2. Place a hand with four (4) fingers stacked vertically beneath the air cell directly underneath the sacral region.
3. Ensure that the 4 fingers can slide with minimal resistance between the patients’ sacral region and the lower portion of the mattress.
4. Adjust the comfort setting as needs.
5. Wait for the mattress to adjust to the selected range.
6. Revaluate with the hand check and adjust to patients’ comfort level.

Recommended Linen:
Drive DeVilbiss Healthcare bed support surfaces are designed to be used with appropriate linens. Deep pocketed fitted or flat sheets are recommended. Multiple layering of linens or underpads beneath the patient should be avoided, when possible, for the prevention and treatment of pressure injuries.
Incontinence
Moisture against the skin surface is an extrinsic risk factor for acquiring a pressure injury as it weakens the skin tissue leading to maceration. To protect skin integrity, incontinence barrier pads may be used to absorb excess moisture.

CLEANING & MAINTENANCE

Warning
Specialty active and reactive support surfaces are designed to redistribute pressure and reduce shearing/friction forces against the patients’skin. Patient migration is possible due to the nature of these products.
Always ensure the patient is positioned properly within the confines of the bed and specialty system.
Note
It is important to follow these procedures before using the system or between patient use.
Control Unit (14530P or 14360XP)
Caution
DO NOT immerse or soak the control unit in any water or fluids.
DO NOT spray any cleaning solution directly on the surface of the control unit.
DO NOT use a Phenolic based cleaning solution as this may cause damage to the case.

1. UNPLUG the control unit from its power source prior to cleaning.

2. Check for external damage and move the control unit to the cleaning area.

3. Place the control unit on a work surface and wipe the outside of the case with a clean cloth to remove any dust or particles. Make sure all areas are clean (top and bottom, both sides).

4. Spray cloth with cleaning solution and clean faceplate and control unit casing. DO NOT allow excess cleaning solution on faceplate or control panel. (If solution gets inside, damage will occur.)
   a. quaternary ammonium solution may be used.

5. After the control unit is thoroughly cleaned and dried, proceed to plug in the control unit and test for normal functioning.

6. Unplug the control unit and store with proper identification tag until needed for use.

7. Avoid long exposure to sunlight.
   Mattress

8. Remove any soiled or used bedding.

9. Examine the mattress for visible soilage of bodily fluids.

10. If no disinfection is required, brush off or wipe down all surfaces of the cover sheet with soap and water before wetting with any liquid disinfectant.

11. If disinfection is required, follow the procedure below:
    a. Use rubber gloves and eye protection.
    b. Unzip the top cover from the mattress.
    c. Prepare detergent/disinfectant solution (registered by the EPA recommended) according to the preparation recommended for correct use-dilution.
    d. 1:9 Bleach and water dilution may be used.
    e. With the mattress fully deflated, wipe down all surfaces around and in between the air cells, including the cells.
    f. Covers may be immersed and soaked in disinfectant for the required incubation period. After presoaking, the cover may be rinsed through a regular cycle in a washer with no soap then laundered with mild detergent (wash temperature 93°F/34°C, rinse temperature 78°F/26°C or on the coldest setting).
    g. Allow all covers and parts to aerate until they are fully dry.

12. Repeat the process with the tubing set: spray/wipe, incubate, and air dry.

13. Dry the mattress on a flat surface area after cleaning, away from exposure to the sun.

14. Avoid long exposure to sunlight.

HANDLING AND STORAGE

• Lay the mattress out flat and upside down.
• oll from the foot end towards the head end; the foot-end strap can then be stretched around the rolled mattress to prevent unrolling.
• Do not fold, crease or stack the mattress.

MAINTENANCE
General

• Check the power cord and plug to see if there are abrasions or excessive wear.
• Check the mattress cover for signs of wear or damage. Ensure the mattress cover and tubes are connected correctly.
• Plug in the control unit and check the airflow from the hose connection port. The airflow should alternate between ports every half-cycle time.
• Check the air hoses to see if there are any kinks or breaks. For replacement, please contact your local agent or dealer.
• Make sure the mattress tube is well connected.
• Check the control unit and make sure both power indicators are off when the switch is turned off.

Low pressure
Examine if there is any air leakage between the control unit and the mattress connections or from the air mattress tubes:

1. Check connectors between the air mattress and control unit. If there is any disconnection, please reconnect it.
2. Check the CPR Valves. Ensure their outlets are sealed.
3. Check the air-connecting tubes. Ensure each single cell is properly functioning.
4. Set the pressure at Auto Firm. Keep the tubes fully inflated and inspect for air leakage.
5. Check if there is any air leakage from cells. Ensure no leakage occurs. If any leakage occurs, please contact your local agent or dealer.

TROUBLESHOOTING

on. If not, please check the below issues:
1.1  Check if power cord is plugged into appropriate voltage AC outlet.
1.2  Contact your provider for possible warranty claim.
2. Air pressure from pump is too low.| 1.  Contact your provider for possible warranty claim.
Mattress issue| 1.  Quick connector on mattress does not connect well with pump.
2. Air tube connected to T/L connector and air valve is loose, CPR connector is not capped.
3.  One way valve is broken.
4. Air cell is leaking.| 1.  Make sure quick connector on mattress is connected well with pump.
2.  Make sure T/L connector and air valve is connected well, CPR connector is capped well.
3.  Change air cell.
4.  Contact your provider for possible warranty claim.
Mattress has pillow function, but air cells fail to inflate.| 1.  One way valve is assembled reversely.| 1. Assemble the one way valve in correct direction.
Pump is working but syn- chronous motor does not work; thus mattress does not alternate, and alternate failure alarm is activated.| 1.  Synchronous motor is out of order.
2.  Wires inside synchronous motor not connect well.
3.  Lower PCB is out of order.| 1.  Contact your provider for possible warranty claim.
Pump and motor keep working, but cycle time is incorrect. The alternate failure alarm is activated.| 1.  Micro switch on the exchanger is out of order.
2.  Lower PCB is out of order.| 1.  Contact your provider for possible warranty claim.
When powered on, compres- sor stop after working some time; but the exchanger keep rotary.| 1.   Pressure detector is out of order.| 1.  Contact your provider for possible warranty claim.
Mattress pressure is low but alarm is not activated.| 1.   Pressure detector is out of order.| 1.  Contact your provider for possible warranty claim.
Push button on panel is not operated well, and LED indicator does not light up.| 1.  Push button is not operated well.
2.  LED is out of order.| 1.  Contact your provider for possible warranty claim.
Mattress pressure is too high or too low.| 1.  Pressure sensor is out of order.| 1.  Contact your provider for possible warranty claim.
Power failure alarm can’t be activated after power failure.| 1.  Battery is out of order.| 1.  Contact your provider for possible warranty claim.

SPECIFICATION

function and low air loss
Alternate/Static/Seat inflate mode| Quick connectors
Size: 31cm (L) x 12.5cm (W) x 21cm (H)| Maximum Weight Capacity: 450 lbs
Weight: 2.5 kg|
FUSE: T1AL 250V|

Note
The above specifications are also applicable to those areas operating with the same power supply range.
The Med Aire Edge Mattress Replacement system has been tested and certified for the following standards:

• CE
• UL

WARRANTY

14360-B: 18 months for control unit and mattress
Your Drive brand product is warranted to be free of defects in materials and workmanship for 18 months of the original consumer purchaser.
This device was built to exacting standards and carefully inspected prior to shipment. This 18 month Limited Warranty is an expression of our confidence in the materials and workmanship of our products and our assurance to the consumer of years of dependable service.
This warranty does not cover device failure due to owner misuse or negligence, or normal wear and tear.
The warranty does not extend to non-durable components, such as rubber accessories, casters, and grips, which are subject to normal wear and need periodic replacement.
If you have a question about your Drive device or this warranty, please contact an authorized Drive dealer.
14360-P: 18 months for control unit and mattress.
Your Drive brand product is warranted to be free of defects in materials and workmanship for 18 months of the original consumer purchaser.
This device was built to exacting standards and carefully inspected prior to shipment. This 18 month Limited Warranty is an expression of our confidence in the materials and workmanship of our products and our assurance to the consumer of years of dependable service.
This warranty does not cover device failure due to owner misuse or negligence, or normal wear and tear.
The warranty does not extend to non-durable components, such as rubber accessories, casters, and grips, which are subject to normal wear and need periodic replacement.
If you have a question about your Drive device or this warranty, please contact an authorized Drive dealer.

99 Seaview Boulevard
Port Washington, NY 11050
Phone:516-998-4600
Fax:516-998-4601
www.drivemedical.com
REV 0.02.20

Documents / Resources

| drive 14360-P Low Air Loss Mattress Replacement System [pdf] User Manual
14360-P Low Air Loss Mattress Replacement System, 14360-P, Low Air Loss Mattress Replacement System, Loss Mattress Replacement System, Mattress Replacement System
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References

• Drive DeVilbiss Healthcare | Home Page for Businesses
• Manual-Hub.com – Free PDF manuals!
• Medical Devices | FDA

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