stryker 1806 IsoFlex SE Support Surface User Manual

IsoFlex SET™ supports surface
Operations Manual
REFI 1806

Symbols

| Refer to the instruction manual/booklet
---|---
| Consult instructions for use
| General warning
| Caution
| Catalog number
| Serial number
| For US Patents see www.stryker.com/patents
| Authorized representative in the European Community
| European medical device
****| Manufacturer
| Date of manufacture
| Importer
| CE mark
| Safe working load
| Type B applied part
| Mass of product
| Wash by hand
Do not tumble dry
Do not dry clean
Do not iron
Allow to completely air dry
| Chlorinated bleach
| Keep dry
| Stacking limit by number
| Do not use sharp objects to open the package.

Warning/Caution/Note Definition

The words WARNING, CAUTION, and NOTE carry special meanings and should be carefully reviewed.

WARNING
Alerts the reader about a situation that, 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 that, 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.

Summary of safety precautions

Always read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.

WARNING

• Always use a minimum of two people to move the support surface.
• Always check the 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 side rail coverage may be compromised with the use of an overlay.
• Always consider the use of side rails. The safe use of the support surface is maximized when used in conjunction with side rails and there may be an increased risk of falls when side rails are not present. Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Consider local policies regarding the use of side rails. The physician operator or responsible parties should determine whether and how to use side rails 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.
• Do not use the support surface on a larger or smaller frame width or length. This product is intended to match the stretcher litter deck. This is to avoid the risk of support surface sliding and patient injury.
• Always inspect for foreign objects between the support surface and support platform. Foreign objects may cause the support surface to slide on the support platform.
• Do not use the support surface when gaps are present. The risk of entrapment can develop when the support surface is placed on frames that leave gaps of even a few inches between the support surface and the headboard, footboard, and side rails.
• 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.
• Do not use the support surface as a transfer device.
• Do not exceed the safe working load of 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. (7.6 cm), use a transfer bridge to fill the gap. A transfer bridge is meant to ease the transfer of a patient from one patient support platform to another.
• Always make sure that the opposite side rail is raised when placing a patient on the support surface to reduce the risk of patient falls.
• Always monitor the patient’s condition at regular intervals for patient safety.
• Do not wash the internal components of this support surface. Discard the support surface if contamination is found inside.
• Do not immerse the support surface.
• 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 before each use. If compromised immediately remove the support surface from service.
• Always make sure that you wipe each product with clean water and thoroughly dry each product after any application of chemical solutions. Some chemical solutions 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 may cause premature degradation of critical components. Failure to follow these instructions may void your warranty.

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 operations resulting in injury to the patient or operator. Modifying the product also voids its warranty.

•  Always be aware of devices or equipment that are placed on 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 put overlays or accessories inside the cover to avoid the risk of reducing pressure redistribution performance.

• Always evaluate the appropriate CPR protocol to be used with this product before operating.

• Do not allow liquid to seep into the zipper area or watershed cover barrier when washing the underside of the support surface. Fluids allowed to come in contact with the zipper may leak into the support surface.

• Do not iron, dry-clean, or tumble dry the support surface covers.

• Do not power wash the support surface as this may damage the product.

• 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.

• Do not over-expose the covers to higher concentration chemical solutions as these may degrade the covers.

• Do not use accelerated hydrogen peroxides or quaternary that contain glycol ethers as they may damage the cover and reduce the legibility of the graphics.

• Failure to follow manufacturing instructions may also affect the useful life of the support surface cover.

• The fire barrier may cause skin irritation.

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 operations resulting in injury to the patient or operator. Modifying the product also voids its warranty.

Note

• 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
IsoFlex SE™ is a non-powered support surface that assists in improving human patient outcomes through redistribution of pressure, shear management, and comfort enhancement.

Indications for use
IsoFlex SE assists in the prevention and treatment of all pressure injury stages (including stages 1, 2,3, 4, Unstageable Pressure Injury, and Deep Tissue Pressure 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 injuries. The sloped heel section of the product assists in off-loading pressure on the heels.
The dimensions of IsoFlex SE are intended to match the stretcher litter deck. The stretcher support surface is intended to be used for short-term stays (treatment and recovery). This product is not intended to be used for long- term patient stays.
Additionally, this product is not intended to be used within a home healthcare setting.
IsoFlex SE shall be used with a support surface cover at all times. The support surface cover can interact with all external skin.
Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors).
This support surface is for use by patients in an acute care setting. This may include emergency department, Pre-operative, Transport, Endoscopy, GI, critical care, step down, progressive care, med/Surg, sub-acute care, and post-anesthesia care unit (PACU), operating room, or other locations as prescribed.

Clinical benefits
Assists in the prevention and treatment of all pressure ulcers or pressure injuries

Contraindications
None known.
Expected life
The IsoFlex SE internal components have a three-year expected life under normal use, and conditions, and with appropriate periodic maintenance for the support surface.
The IsoFlex SE cover and fire barrier have a one-year expected service life under normal use, and conditions, and with appropriate periodic maintenance for the support surface.
Disposal/recycle
Always follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life.

Specifications

Dry polymer gel 70%
Product compliance reference| EN 597-1
EN 597-2
CAL TB 117, 129
USA 16 CFR 1632, 1633| BS 6807:2006, Clause 9
Boston BFD1X-11| Method 27.7-1979 of CAN 2-4.2 M77
UNI-9175 Italy
Environmental conditions| Operation| Storage and transportation
---|---|---
Ambient temperature| |
Relative humidity (non-condensing)
Atmospheric pressure

Stryker reserves the right to change specifications without notice.

Contact information
Contact Stryker Customer Service or Technical Support at 1-800-327-0770.
Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002
USA
Note – The user and/or the patient should report any serious product- related incident to both the manufacturer and the Competent authority of the European Member State where the user and/or patient is established.
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.
Serial number location

Setup

WARNING

• Always use a minimum of two people to move the support surface.
• Always check the 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 side rail coverage may be compromised with the use of an overlay.
• Always consider the use of side rails. The safe use of the support surface is maximized when used in conjunction with side rails and there may be an increased risk of falls when side rails are not present. Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Consider local policies regarding the use of side rails. The physician operator or responsible parties should determine whether and how to use side rails 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.
• Do not use the support surface on a larger or smaller frame width or length. This product is intended to match the stretcher litter deck. This is to avoid the risk of support surface sliding and patient injury.
• Always inspect for foreign objects between the support surface and support platform. Foreign objects may cause the support surface to slide on the support platform.
• Do not use the support surface when gaps are present. The risk of entrapment can develop when the support surface is placed on frames that leave gaps of even a few inches between the support surface and the headboard, footboard, and side rails.
• 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.

CAUTION

• Always be aware of devices or equipment that are placed on 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 put overlays or accessories inside the cover to avoid the risk of reducing pressure redistribution performance.
  Note – 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.

To set up the support surface:

1. Make sure that the support surface fits the frame on which the product is being placed.
2. Make sure that the dedicated sloped heel section is installed at the foot end of the frame.
3. Place linens on the support surface per hospital protocols.

Operation

Transferring a patient from one patient support platform to another
WARNING

• Do not use the support surface as a transfer device.
• 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.
• Do not exceed the safe working load of 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. (7.6 cm), use a transfer bridge to fill the gap. A transfer bridge is meant to ease the transfer of a patient from one patient support platform to another.
• Always make sure that the opposite side rail 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 support surface 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 on 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.

Managing incontinence and drainage
WARNING – Always monitor the patient’s 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.
Selecting the appropriate Cardiopulmonary Resuscitation (CPR) protocol
CAUTION – Always evaluate the appropriate Cardiopulmonary Resuscitation (CPR) protocol to be used with this product before operating.

Accessories and parts

These parts are currently available for purchase. Call Stryker Customer Service: at 1-800-327-0770 for availability and pricing.

Preventive maintenance

Remove the product from service before performing preventive maintenance. At a minimum, check all items listed during annual preventive maintenance for all Stryker Medical products. You may need to perform preventive maintenance checks more frequently based on your level of product usage.
Note – Wash the exterior of the support surface before inspection, if applicable.
Inspect the following items:
Zipper and covers (top and bottom) are free of tears, cracks, cuts, holes, or other openings Internal components for signs of staining from fluid ingress or contamination by fully unzipping the covers Labels for legibility, proper adherence, and integrity
Foam and gel components have not degraded or come apart
Fire barrier for rips or other visible signs of damage (If excessive wear of the fire barrier is observed, replacement is recommended)

Product serial number:

Completed by:| Date:

Cleaning and disinfecting with wipes

For the United States only. Confirm availability for your configuration or region. Call Stryker Customer Service: 1-800-327-0770.
Stryker’s preferred wipes (2060-000-001 6” x 10” or 2060-000-002 9” x 12”) include the following active ingredients:

• n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium chloride – 0.154%
• n-Alkyl (68% C12, 32% C14) dimethyl ethyl benzyl ammonium chloride – 0.154%
• Isopropanol – 21.000%

Non-active ingredient: Ethylene Glycol Monobutyl Ether – < 3%
Note – For safety information, read the product label.
To clean or disinfect the external product surface:

1. To clean, wipe external surfaces with a fresh, clean wipe to remove all visible soils. Repeat as necessary until the product is clean.
   Note
   • Use as many wipes as necessary.
   • Complete step 1 before you disinfect.

2. To disinfect, wipe external surfaces with a fresh, clean wipe until wet. Allow the external surface to remain wet for two minutes at room temperature.

3. Allow the product to dry before you return it to service.

Support surface care

WARNING

• Do not wash the internal components of this support surface. Discard the support surface if contamination is found inside.
• Do not immerse the support surface.
• 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 before each use. If compromised immediately remove the support surface from service.
• Always make sure that you wipe each product with clean water and thoroughly dry each product after any application of chemical solutions. Some chemical solutions 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 may cause premature degradation of critical components. Failure to follow these instructions may void your warranty.

CAUTION

• Do not allow liquid to seep into the zipper area or watershed cover barrier when washing the underside of the support surface. Fluids allowed to come in contact with the zipper may leak into the support surface.

• Do not iron, dry-clean, or tumble dry the support surface covers.

• Do not power wash the support surface as this may damage the product.

• 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.

• Do not over-expose the covers to higher concentration chemical solutions as these may degrade the covers.

• Do not use accelerated hydrogen peroxides or quaternary that contain glycol ethers as they may damage the cover and reduce the legibility of the graphics.

• Failure to follow manufacturing instructions may also affect the useful life of the support surface cover.
  The support surface cover is resistant to the following chemical solutions:

• Quaternary (active ingredient – ammonium chloride) that contains less than 3% glycol ether

• Phenols (active ingredient – o-phenyl phenol)

• Chlorinated bleach solution (use 1 part bleach (5.25% sodium hypochlorite) to 10 parts of water which equal 4773 ppm of available chlorine (400 mL of a 5.25% bleach solution per 4000 mL water))

• 70% isopropyl alcohol
  Follow hospital protocol for support surface care in between patients to avoid the risk of cross-contamination and infection.

Cover replacement

WARNING – Do not wash the internal components of this support surface. Discard the support surface if contamination is found inside.
Tools required:

• None

Procedure:

1. Unzip the cover.
2. Fold the top of the cover to the patient’s right side and then remove the foam crib assembly from the stretcher and set it aside.
3. Discard the old cover.
4. Place the new cover, unzipped and open, on the frame with the grey bottom cover on the litter and the top cover folded over the patient’s right side of the stretcher.
5. Carefully place the foam crib assembly on top of the bottom part of the cover to make sure that the foam crib is aligned with the cover.
6. Fold the top cover over the top of the foam crib assembly. Make sure that the top cover is aligned with the foam crib assembly.
7. Zip the cover to close.

Fire barrier replacement

WARNING – Do not wash the internal components of this support surface. Discard the support surface if contamination is found inside.
CAUTION – The fire barrier may cause skin irritation.
Tools Required:

• None

Procedure:

1. Unzip the cover.

2. Fold the top of the cover to the patient’s right side.

3. Starting at the foot end, roll up the fire barrier on the foam crib assembly.
   Note – Work from side to side, a little at a time, to move the fire barrier to the top of the support surface.

4. Discard the old fire barrier.

5. Starting at the head end, roll the new fire barrier down and slide over the foam crib assembly.
   Note – Slide the fire barrier down the foam crib assembly, working from side to side, to make sure that the fire barrier is tight on the foam crib assembly.

6. Align the foam crib assembly on top of the bottom part of the cover.
   Note – Spread the excess fire barrier material equally below the foam crib assembly at the foot end.

7. Make sure that the fire barrier covers all of the internal components.

8. Fold and align the top cover over the top of the foam crib assembly.

9. Zip the cover to close.

**** Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002
USA
1806-009-001 Rev AA.0
WCR: AD.4
2021-11

References

• Patents | Stryker
• Stryker Medical - Tech Web

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