Stryker IsoFlex LAL 2860 Manual

2016/03 C.12860-109-005 REV C www.stryker.com
International - EN FR DE ES PT IT NL
DA SV FI PL NN JA
Operations/Maintenance Manual
IsoFlex LAL™ Support Surface
2860

sample text

2016/03 C.0 2860-109-005 REV C www.stryker.com
IsoFlex LAL™ Support Surface
2860
Operations/Maintenance Manual

sample text

www.stryker.com 2860-109-005 REV C
English
EN
Symbols
Operating instructions / Consult instructions for use
General warning
Caution
Catalogue number
Serial number
Batch code
Manufacturer
CE mark
Safe working load
Mass of product
Class II with the powered low air loss (LAL)
Wash by hand
Do not tumble dry
Do not dry clean
Do not iron
Allow to completely air dry
Chlorinated bleach
Keep dry

2860-109-005 REV C www.stryker.com
English
EN
Symbols
Do not stack more than 10 high
Do not use sharp object to cut open the package

www.stryker.com 2860-109-005 REV C 1-1
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EN
Table of Contents
Warning/Caution/Note Definition ...............................................................................................................1-2
Summary of safety precautions.................................................................................................................1-3
Introduction...........................................................................................................................................1-5
Product description...........................................................................................................................1-5
Intended use ...................................................................................................................................1-5
Expected service life.........................................................................................................................1-5
Contraindications .............................................................................................................................1-6
Specifications..................................................................................................................................1-6
Contact information ..........................................................................................................................1-7
Serial number location ......................................................................................................................1-8
Date of manufacture.........................................................................................................................1-8
Serial number key ............................................................................................................................1-8
Product illustration............................................................................................................................1-9
Product features ............................................................................................................................ 1-10
Operation ........................................................................................................................................... 1-11
Installing the support surface............................................................................................................ 1-11
Applying the linens ......................................................................................................................... 1-11
Transferring a patient from one patient support platform to another .......................................................... 1-12
Managing incontinence and drainage ................................................................................................. 1-13
Cleaning............................................................................................................................................. 1-14
Disinfecting......................................................................................................................................... 1-15
Preventive maintenance ........................................................................................................................ 1-16
Checking the tolerance of the gel compression set ............................................................................... 1-16
Quick reference replacement parts.......................................................................................................... 1-18
Service .............................................................................................................................................. 1-20
Top 360 cover replacement.............................................................................................................. 1-20
Bottom 360 cover replacement ......................................................................................................... 1-20
Fire barrier replacement .................................................................................................................. 1-21
Cap with tether replacement............................................................................................................. 1-22
Warranty ............................................................................................................................................ 1-23
Warranty exclusion and damage limitations ......................................................................................... 1-23
To obtain parts and service .............................................................................................................. 1-24
Return authorization........................................................................................................................ 1-24
Damaged product........................................................................................................................... 1-24
International warranty clause............................................................................................................ 1-24
Patent information.......................................................................................................................... 1-24

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Warning/Caution/Note efinition
The words WARNING,CAUTION, and NOTE carry special meanings and should be carefully reviewed.
WARNING
Alerts the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe
potential serious adverse reactions and safety hazards.
CAUTION
Alerts the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the
user or patient or damage to the product or other property. This includes special care necessary for the safe and
effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or
misuse.
Note: Provides special information to make maintenance easier or important instructions clearer.

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Summary of safety precautions
Always read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.
WARNING
• Always check patient’s skin regularly. Consult a physician if erythema or skin breakdown occurs. Serious injury
could result if the patient’s skin condition is left untreated.
• Always use extra caution and supervision to help reduce the risk of a patient fall. Patient stability and siderail
coverage may be compromised with the use of an overlay.
• Always leave the bed frame in the lowest position when the patient is unattended to help reduce the number and
severity of falls.
• Always consider the use of siderails. The safe use of the support surface is maximized when used in conjunction
with siderails and there may be an increased risk of falls when siderails are not present. Serious injury or death can
result from the use (potential entrapment) or non-use (potential patient falls) of siderails or other restraints.
Consider local policies regarding the use of siderails. The physician, operator, or responsible parties should
determine whether and how to use siderails based on each patient’s individual needs.
• Always use extra caution with a patient at risk of a fall (such as agitated or confused) to help reduce the likelihood
of a fall.
• Always use extra caution when reading radiology images taken of a patient on this support surface as internal
components can cause artifacts and distort readings.
• Always install the IsoFlex LAL support surface on Stryker bed frames. See compatible frames in the specification
table. This is to avoid the risk of a safety hazard including but not limited to bodily injury.
• Do not use the support surface when gaps are present. The risk of entrapment can develop when the support
surface is placed on bed frames that leave gaps of even a few inches. between the support surface and the
headboard, footboard, and siderails.
• Do not stick needles into a support surface through the support surface cover. Holes may allow body fluids to enter
the inside (inner core) of the support surface and could cause cross-contamination, product damage, or product
malfunction.
• Always evaluate the appropriate CPR protocol to use with this product.
• Always be aware of devices or equipment that are placed on the top of the support surface. Damage to the surface
may occur due to the weight of the equipment, heat generated by the equipment, or sharp edges on the equipment.
• Do not use the support surface as a transfer device.
• Do not use the support surface handles to lift or move the support surface with a patient on board.
• Do not transfer patient from one bed to another using the support surface with a patient on it.
• Do not exceed the safe working load of the hospital bed frame when supporting both the patient and the support
surface. Excess weight could cause unpredictable safety and performance of this product.
• Always make sure that the patient support platforms and their respective transfer gaps are adequate to support the
patient. If the space between the two patient support platforms is greater than 3 in. (7,62 cm), use the transfer
bridge to fill the gap. The transfer bridge is meant to ease transfer of a patient from one patient support platform to
another.
• Always make sure that the opposite siderail is raised when placing a patient on the support surface to reduce the
risk of patient fall.
• Always monitor the patient condition at regular intervals for patient safety.
• Do not immerse the support surface in cleaning or disinfectant solutions.
• Always inspect support surface covers (top and bottom) for tears, punctures, excessive wear, and misaligned
zippers each time the covers are cleaned. If compromised immediately remove the support surface covers from
service and replace the covers to prevent cross-contamination.
• Do not iron, dry-clean, or tumble dry the support surface covers.
• Always disinfect the support surface between patients to avoid the risk of cross-contamination and infection.

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Summary of safety precautions
WARNING (CONTINUE )
• Always make sure that you wipe each product with clean water and thoroughly dry each product after cleaning.
Some cleaning agents are corrosive in nature and may cause damage to the product if you use them improperly. If
you do not properly rinse and dry the product, a corrosive residue may be left on the surface of the product that
could cause premature degradation of critical components. Failure to follow these cleaning instructions may void
your warranty.
• Do not allow liquids to pool on the support surface.
• Always completely dry the support surface covers before storing, adding linens, or placing a patient on the surface.
Drying the product helps to prevent the performance of the product from being impaired.
CAUTION
• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in
this manual.
• Do not modify the product or any components of the product. Modifying the product can cause unpredictable
operation resulting in injury to patient or operator. Modifying the product also voids its warranty.
• Do not put overlays or accessories inside the cover to avoid the risk of reducing pressure redistribution
performance.
• Do not allow liquid to seep into the zipper area or watershed cover barrier when cleaning the underside of the
support surface. Fluids allowed to come in contact with the zipper may leak into the support surface.
• Do not over expose the covers to higher concentration disinfectant solutions as these may degrade the covers.
• Do not use accelerated hydrogen peroxides or quaternaries that contain glycol ethers as they may damage the
cover and reduce the legibility of the artwork.

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Introduction
This manual assists you with the operation or maintenance of your Stryker product. Read this manual before operating
or maintaining this product. Set methods and procedures to educate and train your staff on the safe operation or
maintenance of this product.
CAUTION
• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in
this manual.
• Do not modify the product or any components of the product. Modifying the product can cause unpredictable
operation resulting in injury to patient or operator. Modifying the product also voids its warranty.
Notes
• This manual is a permanent part of the product and should remain with the product even if the product is sold.
• Stryker continually seeks advancements in product design and quality. This manual contains the most current
product information available at the time of printing. There may be minor discrepancies between your product and
this manual. If you have any questions, contact Stryker Customer Service or Technical Support at 1-800-327-0770.
Product description
The non-powered Stryker model 2860 IsoFlex LAL™ support surface assists in improving human patient outcomes by
equalizing pressure and enhancing comfort. IsoFlex LAL is available in different dimensions see the specifications
table. IsoFlex LAL has a breathable cover to assist in moisture management of the skin. There is an optional low air loss
(LAL) pump.
Intended use
The IsoFlex LAL support surface assists in the prevention and treatment of all pressure ulcers stages (including stages
I, II, III, IV, unstageable, and deep tissue injury) and is recommended to be implemented in combination with clinical
evaluation of risk factors and skin assessments made by a health care professional.
This support surface is for use with human patients with existing or at risk of incurring pressure ulcers. The patient must
not exceed the safe working load as specified by the support surface. A healthcare professional should determine the
use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement
for this support surface is two years.
IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all
external skin.
This support surface is for use by patients in an acute care setting. This may include critical care, step down,
progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a
physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors).
Expected service life
The IsoFlex LAL support surface has a ten year expected service life under normal use, conditions, and with
appropriate periodic maintenance.
The IsoFlex LAL covers have a three year expected service life under normal use, conditions, and with appropriate
periodic maintenance.

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Introduction
Contraindications
Stryker promotes the clinical assessment of each patient and appropriate usage by the operator.
IsoFlex LAL support surface is not intended to:
• be used in a home health environment setting
• be used as a sterile product
• include a measuring function
• be used with a patient less than two years of age
Specifications
Model mattress with Equilibrium cover by
artex®¹
2860-000-016 2860-000-018
Model mattress with alternative END406
cover by artex®
2860-000-024 2860-000-026
Length 84 in 213,4 cm 80 in. 203,2 cm
Width 35 in. 88,9 cm 35 in. 88,9 cm
Thickness 6 in. 15,2 cm 6 in. 15,2 cm
Weight 57 lb 25,9 kg 56 lb 25,4 kg
Compatible frames InTouch®, GoBed® II, 3002 S3,
3005 S3, and the Epic® II
Bed frames that support 84 in. x 35
in. (213,4 cm x 88,9 cm) support
surface
An assessment by the healthcare facility or end user is to be completed
if the support surface is used with other flat deck (35” x 84” or 35”x
80”) bed frames. The combination of the support surface installed on a
flat deck bed frame must meet the applicable IEC bed standards.
Safe working load 500 lb (226,8 kg)
Therapeutic weight 50 lb - 350 lb (22,7 kg - 158,7 kg)
Stryker AIR™ Pump compatible with IsoFlex LAL support surface
Part number Voltage Cord type
2862-000-006 230 D
2862-000-008 230 E
2862-000-010 230 F
2862-000-012 230 G
2862-000-014 230 I black label
2862-000-016 230 J
2862-000-018 230 K
2862-000-020 230 L
2862-000-022 230 M

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Introduction
Specifications (Continued)
Stryker AIR™ Pump compatible with IsoFlex LAL support surface
Part number Voltage Cord type
2862-000-024 230 N
2861-000-027 115 B
2862-000-030 230 I transparent label
Stryker reserves the right to change specifications without notice.
¹artex is a registered trademark of Dartex Coatings, Ltd.
For more information about Stryker AIR™ pump, see the manufacturer’s instructions for use.
Environmental conditions Operation Storage and transportation
Ambient temperature
Relative humidity (non-condensing)
Atmospheric pressure
Contact information
Contact Stryker Customer Service or Technical Support at: 1-800-327-0770.
Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002
USA
To view your operations or maintenance manual online, see https://techweb.stryker.com/.
Have the serial number (A) of your Stryker product available when calling Stryker Customer Service or Technical
Support. Include the serial number in all written communication.

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Introduction
Serial number location
ate of manufacture
The year of manufacture is the first four digits of the serial number.
Serial number key
YYYYMMZZZZXXNNNNN
YYYY Year
MM Month
ZZZZ First four digits of Stryker part number
XX Last two digits of Stryker part number
NNNNN Sequential numbering (00001-99999)

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Introduction
Product illustration
A Head end D Strap handles (located at the head end
and the foot end)
B Foot end E D-ring (located on each corner of the
bottom cover)
CSupport surface FPump air attachment

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Introduction
Product features
1Pressure redistribution Redistributes pressure in the sacral region with its CoreGel™ technology by
allowing immersion and envelopment to occur
2Shear management Moves freely with the patient to assist in the reduction of shear forces at the
interface between the surface and the patient with ShearGel™ support layer
3 Moisture management Provides air flow with the LAL system to assist managing the heat and humidity
of the patient’s skin

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Operation
Installing the support surface
WARNING
• Always check patient’s skin regularly. Consult a physician if erythema or skin breakdown occurs. Serious injury
could result if the patient’s skin condition is left untreated.
• Always use extra caution and supervision to help reduce the risk of a patient fall. Patient stability and siderail
coverage may be compromised with the use of an overlay.
• Always leave the bed frame in the lowest position when the patient is unattended to help reduce the number and
severity of falls.
• Always consider the use of siderails. The safe use of the support surface is maximized when used in conjunction
with siderails and there may be an increased risk of falls when siderails are not present. Serious injury or death can
result from the use (potential entrapment) or non-use (potential patient falls) of siderails or other restraints.
Consider local policies regarding the use of siderails. The physician, operator, or responsible parties should
determine whether and how to use siderails based on each patient’s individual needs.
• Always use extra caution with a patient at risk of a fall (such as agitated or confused) to help reduce the likelihood
of a fall.
• Always use extra caution when reading radiology images taken of a patient on this support surface as internal
components can cause artifacts and distort readings.
• Always install the IsoFlex LAL support surface on Stryker bed frames. See compatible frames in the specification
table. This is to avoid the risk of a safety hazard including but not limited to bodily injury.
• Do not use the support surface when gaps are present. The risk of entrapment can develop when the support
surface is placed on bed frames that leave gaps of even a few inches. between the support surface and the
headboard, footboard, and siderails.
• Do not stick needles into a support surface through the support surface cover. Holes may allow body fluids to enter
the inside (inner core) of the support surface and could cause cross-contamination, product damage, or product
malfunction.
• Always evaluate the appropriate CPR protocol to use with this product.
• Always be aware of devices or equipment that are placed on the top of the support surface. Damage to the surface
may occur due to the weight of the equipment, heat generated by the equipment, or sharp edges on the equipment.
CAUTION
• Do not put overlays or accessories inside the cover to avoid the risk of reducing pressure redistribution
performance.
Prerequisite: A minimum of two operators is required for this task.
To install the support surface:
1. Make sure that the support surface properly fits on the bed frame where you are placing the product.
2. Make sure that you install the dedicated sloped heel section at the foot end of the bed frame.
3. Place the linens on the support surface per hospital protocol.
Applying the linens
To apply the linens:
1. Apply the linens using the “D” rings for a flat sheet.

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Operation
Applying the linens (Continued)
2. Thread the four linen corners through the “D” rings (C) on the bottom cover to secure the linens (A) to the support
surface (B).
Figure 1-1: Apply linens
Transferring a patient from one patient support platform to another
WARNING
• Always check patient’s skin regularly. Consult a physician if erythema or skin breakdown occurs. Serious injury
could result if the patient’s skin condition is left untreated.
• Do not use the support surface as a transfer device.
• Do not use the support surface handles to lift or move the support surface with a patient on board.
• Do not transfer patient from one bed to another using the support surface with a patient on it.
• Do not exceed the safe working load of the hospital bed frame when supporting both the patient and the support
surface. Excess weight could cause unpredictable safety and performance of this product.
• Always make sure that the patient support platforms and their respective transfer gaps are adequate to support the
patient. If the space between the two patient support platforms is greater than 3 in. (7,62 cm), use the transfer
bridge to fill the gap. The transfer bridge is meant to ease transfer of a patient from one patient support platform to
another.
• Always make sure that the opposite siderail is raised when placing a patient on the support surface to reduce the
risk of patient fall.
To transfer the patient from one patient support surface to another:
Prerequisite: Follow hospital protocols required to transfer a patient from one patient support platform to another.
1. Position one patient support platform alongside the other patient support platform while minimizing the gap between
the two platforms.
2. Set the brakes for both patient support platforms.
3. Adjust the patient support platform heights so that they are level with one another.
4. Transfer the patient following all applicable safety rules and institution protocols for patient and operator safety.
Note: Do not use the IsoFlex LAL support surface to transfer the patient to other surfaces.
5. Center the patient on the support surface (Figure 1-2 on page 1-13).

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Operation
Transferring a patient from one patient support platform to another (Continued)
Figure 1-2: Center patient
Managing incontinence and drainage
WARNING
Always monitor the patient condition at regular intervals for patient safety.
You can use disposable diapers or incontinence pads to manage incontinence. Always provide appropriate skin care
after each incontinence episode.

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Cleaning
WARNING
• Do not immerse the support surface in cleaning or disinfectant solutions.
• Do not allow liquid to pool on the support surface.
• Always inspect support surface covers (top and bottom) for tears, punctures, excessive wear, and misaligned
zippers each time the covers are cleaned. If compromised immediately remove the support surface covers from
service and replace the covers to prevent cross-contamination.
• Always make sure that you wipe each product with clean water and thoroughly dry each product after cleaning.
Some cleaning agents are corrosive in nature and may cause damage to the product if you use them improperly. If
you do not properly rinse and dry the product, a corrosive residue may be left on the surface of the product that
could cause premature degradation of critical components. Failure to follow these cleaning instructions may void
your warranty.
• Do not iron, dry-clean, or tumble dry the support surface covers.
• Always completely dry the support surface covers before storing, adding linens, or placing a patient on the surface.
Drying the product helps to prevent the performance of the product from being impaired.
CAUTION
• Do not allow liquid to seep into the zipper area or watershed cover barrier when cleaning the underside of the
support surface. Fluids allowed to come in contact with the zipper may leak into the support surface.
Note: If the optional pump is installed, unplug the product before cleaning.
Always follow hospital protocol for cleaning and disinfecting.
To clean the support surface covers between patient uses, follow these steps in order:
1. Using a clean, soft, damp cloth, wipe the support surface covers with a mild soap and water solution to remove
foreign material.
2. Wipe the support surface covers with a clean, dry cloth to remove any excess liquid or cleaning agent.
3. Dry thoroughly.