Sunrise Medical Jay Dermafloat LAL 1000 Series, Jay Dermafloat 360220-LAL 1000, Jay Dermafloat 360260-LAL 1100HC, Jay Dermafloat 360200-LAL 1100 User Instruction

Jay™Dermafloat™LAL 1000 Series

User Instruction Manual & Warranty

Model 360200 – LAL 1100 – 10" Standard Low Air Loss System Model 360260 – LAL 1100HC – 10" Homecare Low Air Loss System Model 360220 – LAL 1000 – Control Unit

Série Jay™Dermafloat™LAL 1000

Manuel Et Garantie D'Instruction D'Utilisateur

Modèle 360200 – LAL 1100 – 10” Système Institutionnel à Faible Perte d’Air Continue Modèle 360260 – LAL 1100HC – 10” Système Pour Soins à Domiciles à Faible Perte d’Air Continue Modèle 360220 – LAL 1000 - Unité De Commande

Jay™Dermafloat™LAL 1000 Series

Manual Y Garantía De Instrucción Del Utilizador

Modelo 360200 - LAL 1100 – 10” Sistema Estándar de Pérdida Variable de Aire Modelo 360260 - LAL 1100HC – 10” Sistema de Cuidados Terapéuticos Domésticos de Pérdida Variable de Aire Modelo 360220 – LAL 1000 – Unidad De Control

™

Introduction 2 General Product Description 2

Control Unit 3

Standard Low Air Loss Mattress 3 Homecare Low Air Loss Mattress 4

System Specifications 4

Electrical Mechanical

Agency Approvals Safety Instructions & WARNINGS 5 Instructions for Proper Use 7 System Diagram 9 Cleaning Procedures 10

General Cleaning 11

Routine In-Use Cleaning 13 Approved Washing and Drying Procedures 14 Storage and Care 15 Troubleshooting Guide 15 Maintenance 16 Warranty 17

Instructions en Français 18

Instrucciones d’Español 37

INTRODUCTION

This Owner’s Manual was designed to assist both caregivers and patients when using the JAY Dermafloat Low Air Loss Therapy System. It can be used as a continual information resource and we suggest that you keep it handy to answer most of the questions that you may have regarding the set up, cleaning and routine maintenance of the system.

GENERAL PRODUCT DESCRIPTION

The Jay LAL 1000 Series is a portable low air loss mattress replacement designed to economically provide therapeutic benefit to patients suffering from, or at risk of, developing pressure ulcers. The system, consisting of a Master Control Unit, an Air Flotation Mattress and a Therapeutic Comforter, is designed to provide unsurpassed wound care therapy and patient comfort.

The controller is as simple to use, as it is compact. Plug it in and dial the appropriate pressure level. Simple! With a side mounted Quick Disconnect for CPR, the Jay LAL 1000 Series offers basic reliable “true low air loss” therapy previously available in only more complicated and more expensive systems.

The Standard Low Air Loss Mattress base consists of twenty transverse air cushions. Each is over eight inches tall inflated height and spatially oriented above a two inch convoluted foam base. The air cushion material is a low shear nylon, which aids in reducing the chance of skin breakdown. The air cushions are designed with orifices to provide continuous low air loss therapy to aid in the prevention of skin maceration.

The Homecare Low Air Loss Mattress consists of five independent zones connected by a single top membrane. The membrane is perforated to provide continuous low air loss therapy to aid in the prevention of skin maceration.

Covering the entire mattress assembly is a low friction (i.e. low shear producing) 70-denier nylon comforter. The bottom surface of the comforter is coated with a vapor permeable polyurethane film. This coating creates a monolithic, osmotic membrane impermeable to liquids, air, and bacteria though still permeable to water vapor.

Quilted onto the base of the comforter is a spun bonded polyester fiberfill, which exhibits less frictional resistance to nylon than that of the patient’s skin. The significance of this is that when the patient moves, the comforter tends to move relative to the air cushions rather than relative to the patient. Wounds, which can be exacerbated by shearing are in this manner significantly minimized, if not prevented. A secondary feature of this quilting is that it acts to provide a diffusion layer by with the water vapor can be drawn away from the patient. Concentrations of moisture will diffuse throughout, the comforter thus resulting in more efficient evaporation and subsequent reduced skin maceration.

Jay Dermafloat LAL 1000 Series

MASTER CONTROL UNIT FEATURES

· Compact, lightweight, and easy to use.

· Sleek and durable ABS plastic housing with bedside bracket for easy

placement on the footboard of bed.

· Push button connector for quick disconnection and rapid deflation as

needed for CPR.

· Dialed Soft/Firm Comfort Control.

Jay Dermafloat LAL 1100

STANDARD LOW AIR LOSS MATTRESS FEATURES

· Horizontal, tubular cell construction.

· Individual air cushions designed for maximum support area and pressure

distribution.

· Mattress Replacement System, eliminating the compromising effects of

an existing mattress.

· Dimensions 80” x 35” x 10” (2 m x 89 cm, x 25 cm) when fully inflated

(20 - 8” (20 cm) air cells plus a 2” (5 cm) foam base).

Jay Dermafloat LAL 1100HC

HOMECARE LOW AIR LOSS MATTRESS FEATURES

· Single piece top construction makes mattress easy to clean.

· Full mattress replacement consists of 8” (20 cm) air cell height plus

2” (5 cm) convoluted foam base.

SYSTEM SPECIFICATIONS

ELECTRICAL SPECIFICATIONS:

Domestic European Power: 120V 230V Frequency: 60Hz 50 Hz Current: 5A 2.5A Mode of Operation: Continuous Circuit Protection: Fused; 5A, 2500 Slow Blow Fuse or

(2.5A 250V Slow Blow Fuse – 230V Model)

Protection Against Harmful Ingress of Liquids:

Ordinary Protection (IPXO)

MECHANICAL SPECIFICATIONS – Control Unit:

DIMENSIONS: 10" x 9" x 5" (25 cm x 30 cm x 13 cm) WEIGHT: 8 lbs. (3.63 kg.)

5A 120V

AGENCY APPROVALS:

UL 544 & CE Certification

SAFETY INSTRUCTIONS &WARNINGS

1. To avoid damaging your system, be sure the power available at your

location matches the power call out on the rear of the Master Control Unit (i.e. 110V Domestic; 230V European).

2. To avoid electric shock, always plug the Master Control Unit into a

properly ground power source.

3. Do not spill food or liquids into the Master 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.

4. Do not insert items into any openings of the Master Control Unit.

Doing so may cause fire or electrical shock by shorting internal components.

5. Do not block the pump intake on the enclosure. Keep unit away from

radiators or other heat sources.

6. Be sure nothing is placed on the power cable and ensure it is not located

where it can be stepped on or tripped over.

7. Do not attempt to service the Master Control Unit except as explained in

this guide. Always follow installation and servicing instructions closely.

WARNING: The Master Control Unit housing, should only be

opened by qualified technical personnel. Before opening the housing, make sure the unit is turned off and unplugged from its power source.

WARNING: The patient should never be unsupervised when the

bedrails are in the down position. Leaving the patient unsupervised with the bed rails in the down position may increase the likelihood of falls, which may result in patient injury or death.

WARNING: Careful consideration should be made to combine Bed,

Bed Rails and Mattress configuration to account for patient factors including: cognitive abilities, locomotive abilities and any other such circumstances. Failure to consider these factors, in light of an institution’s antientrapment and restraint-free policies, may result in patient injury or death.

WARNING: When using Bed Rails, ensure that gaps and potential

entrapment hazards are adequately reduced. Failure to do so may result in patient injury or death.

DANGER

--EXPLOSION HAZARD--

DO NOT USE IN THE PRESENCE OF FLAMMABLE

ANESTHETICS

Caution: Do not use in the presence of smoking materials or open

flame. Air flowing through the air mattress will support combustion.

Risk of electric shock, do not remove back. Refer servicing to qualified service personnel.

Warning: Never drop or insert any object into any

opening of the master control unit.

INSTRUCTIONS FOR PROPER USE

(Numbers in parentheses refer to Mattress and Bed Diagrams on page 9.)

1. Remove mattress from bed frame (1).

2. Replace mattress with the Jay LAL 1100 Series Standard Low Air

Loss (2) or Homecare Low Air Loss Mattress. Make sure to orient mattress so the air tubing (3) exits the mattress at the foot of the bed.

3. Loop each of the four black nylon straps (4) to the bed frame and secure

with the D-Rings provided.

4. Suspend control unit from the footboard using the two hooks located on

the back of the unit as shown (5). If no footboard exists, place unit on a flat surface near the foot end of the bed. (Be careful not to position the unit on the floor in such a manner that it may become a hazard to foot traffic.)

5. Connect the free end of the tubing (3) to the respective mating connector

located on the side of the pump (6). This “quick connect” fitting can be secured by simply mating the two ends together in a linear but opposing direction. The connector tube for the Homecare Low Air Loss Mattress must be attached to the mattress manifold. Simply join the tube onto the clear tube receptacle.

6. Check that the hose is secure by gently pulling. Ensure the air hose is

not kinked or tucked under the mattress.

7. Cover Jay LAL 1100 Series Standard Low Air Loss Mattress with

the Therapeutic Low-Shear comforter and attach to the mattress D-rings provided. (Verify comforter is loosely fitting so as not to "hammock" patient above the mattress. If comforter appears tight verify ICU size sheet is not covering a standard sized mattress).

8. Carefully plug power cord into a properly grounded outlet. Unit will

enter “STANDBY” mode when dial is set to 0. Settings greater than 1 will automatically initiate the blower operation.

9. Place patient on the Low Air Loss Mattress. (NOTE: The control unit

can inflate the mattress with the patient laying on it.) To assist inpatient ingress/egress as well as normal nursing procedure, the Low Air Loss Mattress can be inflated to maximum by fully rotating the comfort adjust dial in a clockwise direction.

NOTE: To reduce the risk of skin break down, MAX Inflate should not be maintained for greater than 30 minutes. At MAX, the inflation pressure will not exceed 32 mmHg.

10. For proper inflation and patient comfort, adjust pressure by rotating dial

initially to MAX. After maximum inflation has been attained, sequentially reduce the pressure setting by turning knob counterclockwise until approximately four-finger clearance exists between the underlying foam and the patient’s sacral area.

11. For mattress deflation when CPR is needed, disconnect the hose

connector from the controller. Mattress will be fully deflated in less than 15 seconds.

*PLEASE READ ALL SAFETY INSTRUCTIONS &

WARNINGS ON PAGES 5 & 6 BEFORE USE.

JAY DERMAFLOAT LAL 1100 SERIES

STANDARD LOW AIR LOSS MATTRESS DIAGRAM

CLEANING PROCEDURES

Jay LAL 1000 Series Standard Low Air Loss System

1. Control Unit:

WARNING: Disconnect the AC power cord from the wall

outlet before attempting to clean the unit.

Wipe off dust. If necessary, clean the housing exterior with

a disinfectant solution or a mild detergent and a damp cloth.

Then wipe dry.

DO NOT HEAT OR STEAM AUTOCLAVE THE CONTROL

UNIT. NOT EVALUATED AS A STERILE PRODUCT.

NOTE (for 120 volt version): This product incorporates fusing only in the

ungrounded phase conductor. This product must not be used in countries other

than the United States and Canada and must be used only in health care

facilities on grounded systems where conditions of maintenance and supervision

ensure that only qualified persons will service the electrical distribution system.

2. Low Air Loss Mattress:

The Standard Low Air Loss Mattress can be wiped down with a

disinfectant solution or a mild detergent with a damp cloth. Wipe

dry before remaking the bed. When washing by machine,

disassemble mattress soft goods before placing in machine.

Machine washing of the manifold is not recommended, refer to #8

in the general cleaning procedures.

3. Low Shear Comforter:

Comforters are to be laundered between patient uses and/or as

required for patient hygiene. Fill the washing machine with warm

water 70-140°F (21-60°C). Use laundry detergent and/or standard

hospital disinfectants in recommended concentrations. Start the

washer and let the detergent and disinfectant mix fully. Place no

more than four comforters in a single extra large load capacity

washing machine. When wash cycle is complete, remove promptly

from machine and ensure all excess water is drained from load.

Place dryer on LOWEST heat setting, or AIR FLUFF setting if

available, until dry, not to exceed temperatures of 148°F (50°C).

Verify comforter is completely dry before placing under patient,

refer to instructions on page 14.

GENERAL CLEANING PROCEDURES

Jay LAL 1000 Series Standard Low Air Loss System

WARNING: Disconnect the AC power cord from the wall outlet before

attempting to clean the Master Control Unit. Do not heat or steam autoclave any component of the Jay Dermafloat LAL 1000 System.

1. Use rubber gloves and eye protection.

2. Patient care equipment that does not come in contact with mucous membranes or non-contact skin requires low-level disinfections. Wiping surfaces with a detergent/disinfectant in its proper usedilution carries out low-level disinfections.

3. Processing of dirty patient care equipment should take place in a designated area away from clean or sterile supplies and food preparation areas.

4. Detergent/disinfectants should not be mixed with other germicides or detergents. Using the proper dilution insures the most effective killing power of the disinfectant.

5. Wash hands often and well, including after removal of gloves, paying particular attention to around and under fingernails and between fingers.

6. Prepare detergent/disinfectant (reg. by EPA as hospital disinfectant; see page 13) solution according to instructions on label for correct use-dilution. A basin or spray bottle (with product label) can be used. Use a pump to dispense concentrate and fill receptacle with tap water. If using a spray bottle, empty and rinse out spray bottle at end of each day. A fresh preparation of detergent/disinfectant must be prepared daily since the stability of the solution at greater than 24 hours is unknown.

7. With mattress air cushions deflated, thoroughly wipe down individual air cushions on both sides. Allow to air dry.

8. Thoroughly wipe down entire mattress and tubing. If dust or other soilage has accumulated along air manifold, remove using swabs moistened with detergent/disinfectant as necessary. Allow all components to air dry. Wrap mattress in plastic and return to storage area.

9. Thoroughly wipe down outside of control unit and allow to air dry. Cover with plastic and return to storage area.

10. Remove gloves and dispose; wash hands.

ROUTINE IN-USE CLEANING PROCEDURE

Jay LAL 1100 Series Standard Low Air Loss Mattress

1. If comforter becomes soiled (such as with food, medication, or other non-human waste materials) and can be easily cleaned, wear clean gloves, wipe soilage using detergent/disinfectant and dry with a clean cloth or towel.

2. If comforter becomes grossly soiled, or becomes soiled with body substances, wear clean gloves, a plastic apron or gown, and eye protection before removing comforter and disposing according to standard hospital procedures for contaminated waste. Remove and dispose of gloves and apron. Wash hands well. Replace with clean comforter.

3. Comforters may also be laundered between patient uses or as required to maintain good patient hygiene. (See page 14 for complete washing instructions.)

4. If individual air cushions become soiled, wipe down with detergent/disinfectant and either allow to air dry or dry with a clean cloth towel or simply replace air sack with a clean replacement. (Note: Single air cell replacement can be successfully achieved with patient remaining on the mattress).

*The following two recommended products are registered by the EPA as hospital disinfectants. They are both quaternary ammonium compounds; they clean disinfect, and deodorize in one step, and are commonly used in ordinary environmental sanitation of non-critical surfaces.

1. Quaternary Detergent-Disinfectant is manufactured by Airkem

Professional Products, Div. of Ecolab, Inc., Ecolab Center, St. Paul, Minnesota. The EPA registration number for A-33 Liquid is 42964-5.

2. Hi-Tor Germicidal Detergent is manufactured by Huntington

Laboratories, Inc., Huntington, Indiana. The EPA registration number for Hi-Tor Plus is 303-91.

APPROVED WASHING AND DRYING

PROCEDURES FOR

Jay LAL 1100 Series Standard Low Air Loss Mattress

Washing Procedure:

*Please refer to the Cleaning Procedures on page 10 for instructions & do not use bleach or detergents that contain bleach.

Total time for wash cycle = 61 Minutes

Washing Machine

Detergent* Commercial Liquid

Disinfectant LP H SE

Standard Commercial Washer (18 lbs or larger)

40 grams for main wash

(Calgon-Vestal Laboratories). 40 grams for main wash

PreWash

Main Wash

First Rinse

Second Rinse

Final Rinse

Fill up with cold water 1 minute

Pre wash at approx. 86°F

16°C) with normal

(

washing action. Drain 1 minute

Feed water for main wash and add detergent Raise to temperature of

70-140°F (21-60 normal washing action.

Main wash at 70-140°F (21-60°C) Cool Down 2 minutes Drain 1 minute Feed water 1 minute

Rinsing 2 minutes Drain/Spin 3 minutes Feed water 1 minute

Rinse 3 minutes Drain 1 minute Feed water 2 minutes

Rinse 5 minutes Drain and spin (530 rpm) 4 minutes

°C) with

4 minutes

1 minute

21 minutes

8 minutes

DRYING PROCEDURE

After washing, drying can be carried out in a standard commercial dryer at FLUFF or DELICATE setting at temperatures not to exceed 148°F (50°C).

STORAGE AND CARE

Control Unit:

Before use check the power cord and plug for abrasions or excessive wear. Plug in the unit and verify air flows from the unit hose connection port. The power cord may be wrapped around the unit for convenience. Wrap the unit in a plastic bag for dust resistance, then store the unit in an area that is appropriate for an electronic medical device.

Homecare Low Air Loss Mattress:

Gently fold over the deflated air mattress in half or thirds (head and foot section toward the middle) for temporary storage.

Standard Low Air Loss Mattress:

Before use check the air manifold for kinks or breaks. Replace if necessary. Coil the hose loosely and roll the deflated mattress starting at the head end. Use the base mounted straps for containment. Place in a plastic bag for temporary storage.

TROUBLESHOOTING GUIDE

Problem: Loss of power.

Solution: Make certain the power receptacle has power, and the

power ON/OFF switch is in the illuminated “ON” position. Periodic testing will verify proper system operation. Inflation pressures lower than specified can result in poor or reduced patient support.

Problem: Mattress does not inflate or is too soft.

Solution: Make certain the air hose is not kinked, cracked, or split.

Verify the power switch is illuminated, signifying the master control unit has power. Verify the hose quick connect is fully inserted. Verify that all 20 air cushions are connected to the air manifold. Inspect and/or clean intake air filter.

For Technical Support call 1-800-685-5600.

MAINTENANCE

Routine maintenance includes cleaning or replacing the filter as needed. The Filter is located under the top of the housing in the back. A finger bolt and plate keep the filter in place. Visually inspect filter for dirt or heavy debris buildup such as hair and dirt. The Filter can be washed with hand soap and air-dried. Make certain the filter is dry before replacing it. A brittle or damaged filter MUST always be replaced.

Periodic testing will verify proper Jay Dermafloat LAL System operation. Inflation pressures lower than specified can result in poor or reduced patient support.

NOTE: All tests or service should be performed only by qualified

Technical Personnel.

Maintenance Test Schedule:

The following test should be performed every 6 to 9 months. Keep written records of each test.

Electrical Leakage Current Test:

To perform an electrical leakage current test, an electrical leakage analyzer such as those manufactured by "Bio-Tec" or "Cam-Safe" should be used. Follow the manufacturer's instructions for setting up and performing the tests required to determine ground resistance and current leakage.

For safe performance, the unit should not be used if the impedance or leakage current values exceed the maximum allowable values. The maximum ground impedance allowable by UL is 0.1 Ohms with a maximum leakage current of 100 micro amperes (500 micro amperes for 230V Model).

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