Stryker ProForm 281505550007, ProForm 281505550003, ProForm 281505550010, ProForm 281505550009, ProForm 281505550020 Operation Manual

...
PPrrooFFoorrmm™™ nnoonn--ppoowweerreedd ssuuppppoorrtt ssuurrffaaccee
OOppeerraattiioonnss MMaannuuaall
2815
EN ES FR KO PT
2019/04
SSyymmbboollss


10
Refer to instruction manual/booklet
Operating instructions/Consult instructions for use
General warning
Caution
Catalogue number
Serial number
Manufacturer
Safe working load
Wash by hand
Do not tumble dry
Do not dry-clean
Do not iron
Allow to air dry
Chlorinated bleach
For US Patents see www.stryker.com/patents
Keep dry
Do not stack more than 10 high
2815-009-001 Rev D.1 EN
This side up
Fragile
Do not use sharp objects to open the package
Mass of equipment
EN 2815-009-001 Rev D.1
TTaabbllee ooff CCoonntteennttss
Symbols .............................................................................................................................................................1
Warning/Caution/Note Definition ....................................................................................................................2
Summary of safety precautions ...............................................................................................................2
Introduction ..................................................................................................................................................4
Product description ................................................................................................................................4
Intended use..........................................................................................................................................4
Expected service life - standard...............................................................................................................5
Expected life - behavioral health..............................................................................................................5
Contraindications ...................................................................................................................................5
Specifications ........................................................................................................................................5
Standard.........................................................................................................................................5
Behavioral health.............................................................................................................................6
Environmental conditions .................................................................................................................6
Contact information ................................................................................................................................6
Serial number location............................................................................................................................7
Date of manufacture...............................................................................................................................7
Setup...........................................................................................................................................................8
Operation.....................................................................................................................................................9
Transferring a patient from one patient support platform to another ............................................................9
Preventive maintenance ..............................................................................................................................10
Cleaning and disinfecting with wipes......................................................................................................10
Care and maintenance .........................................................................................................................11
Quick reference replacement parts...............................................................................................................12
Cover replacement - Standard model..................................................................................................... 12
2815-009-001 Rev D.1 1 EN
WWaarrnniinngg//CCaauuttiioonn//NNoottee DDeeffiinniittiioonn
The words WWAARRNNIINNGG, CCAAUUTTIIOONN, and NNOOTTEE carry special meanings and should be carefully reviewed.
WWAARRNNIINNGG -- 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.
CCAAUUTTIIOONN -- 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.
NNoottee -- Provides special information to make maintenance easier or important instructions clearer.
SSuummmmaarryy ooff ssaaffeettyy pprreeccaauuttiioonnss
Always read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.
WWAARRNNIINNGG
• Never use the standard model support surface in the behavioral health use environment. The zipper allows access to the internal components which could be used for harm.
• 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 inspect for foreign objects between the support surface and the bed frame. Foreign objects may cause the support surface to slide on the support platform.
• Always consider the use of siderails. The safe use of the support surface is maximized when used in conjunction with siderails. 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.
• Do not use the support surface on a larger or smaller bed frame that does not fit the width, length, or thickness. This is to avoid the risk of the support surface sliding, patient injury, or interference with moving parts of the bed.
• Do not use the support surface when gaps are present. The risk of entrapment can develop when the support surface is placed on non-compatible bed frames.
• 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 use the support surface handles to lift or move the support surface with a patient on board.
• 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. (7.6 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.
• Do not wash the internal components of this support surface. Discard the support surface if a contamination is found inside.
• Do not immerse the product in cleaning or disinfectant solutions.
• Do not allow liquid to pool on the product.
EN 2 2815-009-001 Rev D.1
• 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 dry each product after you clean. Some cleaning agents are corrosive in nature and may cause damage to the product. Failure to follow these cleaning instructions may void your warranty.
CCAAUUTTIIOONN
• 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.
• 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 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 you clean the underside of the support surface. Fluids allowed to come in contact with the zipper may leak into the support surface core.
• 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 dry the support surface covers before you store, add linens, or place a patient on the surface. A dry product helps to prevent impaired performance.
• Do not over expose the covers to higher concentration chemical solutions as these may degrade the covers.
• Do not use accelerated hydrogen peroxides or quaternaries that contain glcyol ether >3% as these chemicals may damage the support surface cover.
• Failure to follow manufacturing instructions may also affect useful life of the support surface cover.
• Always take caution when you replace the support surface cover. The internal fire barrier contains fiberglass fibers. Dust particles from the fibers may cause skin irritation.
2815-009-001 Rev D.1 3 EN
IInnttrroodduuccttiioonn
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.
CCAAUUTTIIOONN
• 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.
NNoottee
• 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.
PPrroodduucctt ddeessccrriippttiioonn
PPrrooFFoorrmm™™ is a 6” thick, non-powered foam support surface for the general patient population. There are articulation cuts on the mattress core. The mattress cover material options include nylon material or END406 by DDaarrtteexx® fabric. All configurations of the product include heel slope at the foot end of the support surface. The dimensions of this product are compatible with SSttrryykkeerr bed frames. See the compatible bed frame list in the specifications section of this manual.
IInntteennddeedd uussee
PPrrooFFoorrmm uses foam to help with pressure redistribution and immersion.
This product is a non-powered support surface that assists in the prevention and treatment of pressure injuries or pressure ulcers (all stages, Unstageable injury, and Deep Tissue injury). We recommend you implement this product in combination with clinical evaluation of risk factors and skin assessments made by a healthcare professional.
The standard Model (281505550001, 281505550003, 281505550005, 281505550007, 281505550020) is intended for the general hospital environment, specifically the acute care healthcare facilities.
The behavioral health Model (281505550009, 281505550010, 281505550011) are intended for use in behavioral care facilities.
PPrrooFFoorrmm shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. A top sheet should be used with this product.
The standard general hospital environment models and the behavioral health models are not intended for:
Patients that exceed the safe working load
Bariatric patients
Home health environment setting
Not a sterile product
Does not contain a measuring function
SSttrryykkeerr promotes the clinical assessment of each patient and appropriate usage by the operator.
EN 4 2815-009-001 Rev D.1
EExxppeecctteedd sseerrvviiccee lliiffee -- ssttaannddaarrdd
The PPrrooFFoorrmm support surface core and covers have a 3 year expected service life under normal use, conditions, and with appropriate periodic maintenance.
EExxppeecctteedd lliiffee -- bbeehhaavviioorraall hheeaalltthh
The PPrrooFFoorrmm support surface has a 3 year expected life under normal use, conditions, and with appropriate periodic maintenance. There are no serviceable parts for this product.
CCoonnttrraaiinnddiiccaattiioonnss
None known.
SSppeecciiffiiccaattiioonnss
500 lb 226.8 kg
Safe working load
Minimum patient weight 50 lb 26.8 kg
NNoottee -- The patient must not exceed safe working load specified by the support surface.
SSttaannddaarrdd
MMooddeell ggeenneerraall ppaattiieenntt
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
Product weight 30 lb 13.6 kg 29 lb 13.2 kg
Top cover material END406 by DDaarrtteexx®
MMooddeell ggeenneerraall ppaattiieenntt
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
Product weight 30 lb 13.6 kg 29 lb 13.2 kg
228811550055555500000011 oorr 228811550055555500002200 bbaaggggeedd 228811550055555500000033
228811550055555500000055 228811550055555500000077
Top cover material Nylon
Mattress material Polyurethane foam
Product compliance with fire barrier 16CFR1632, 16CFR1633, CGSB CAN 2-4.2 Method 27.7-
M77, CAL TB129, BFD IX-11
Compatible frames 3002 SS33™™, 3005 SS33™™, GGooBBeedd® II, SSppiirriitt SSeelleecctt™™with
high quad 4 zone siderails
2815-009-001 Rev D.1 5 EN
BBeehhaavviioorraall hheeaalltthh
MMooddeell 228811550055555500001100,, 228811550055555500001111 228811550055555500000099
Length 80 in. 203.2 cm 84 in. 213.4 cm
Width 35 in. 88.9 cm 35 in. 76 cm
Thickness 6 in. 15.2 cm 6 in. 7.6 cm
Product weight 29 lb 13.2 kg 30 lb 13.6 cm
Top cover material END406 by DDaarrtteexx®®
Mattress material Polyurethane foam
Product compliance with fire barrier 16CFR1632, 16CFR1633, CGSB
CAN 2-4.2 Method 27.7-M77, CAL TB129, BFD IX-11
Compatible frames 3002 SS33™™, 3005 SS33™™, GGooBBeedd®® II,
SSppiirriitt SSeelleecctt™™ with high quad 4 zone siderails, SSppiirriitt®® Behavioral Health Platform Bed
NNoottee -- The Behavioral health covers do not have zippers. The product is not serviceable.
EEnnvviirroonnmmeennttaall ccoonnddiittiioonnss
WWAARRNNIINNGG -- Never use the standard model support surface in the behavioral health use environment. The zipper allows access to the internal components which could be used for harm.
EEnnvviirroonnmmeennttaall ccoonnddiittiioonnss
Ambient temperature
Relative humidity (non-condensing)
Atmospheric pressure
Stryker reserves the right to change specifications without notice.
OOppeerraattiioonn SSttoorraaggee aanndd ttrraannssppoorrttaattiioonn
CCoonnttaacctt iinnffoorrmmaattiioonn
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/.
EN 6 2815-009-001 Rev D.1
Have the serial number (A) of your Stryker product available when calling Stryker Customer Service or Technical Support.
A
Include the serial number in all written communication.
SSeerriiaall nnuummbbeerr llooccaattiioonn
DDaattee ooff mmaannuuffaaccttuurree
The year of manufacture is the first four digits of the serial number.
2815-009-001 Rev D.1 7 EN
SSeettuupp
WWAARRNNIINNGG
• 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 inspect for foreign objects between the support surface and the bed frame. Foreign objects may cause the support surface to slide on the support platform.
• Always consider the use of siderails. The safe use of the support surface is maximized when used in conjunction with siderails. 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.
• Do not use the support surface on a larger or smaller bed frame that does not fit the width, length, or thickness. This is to avoid the risk of the support surface sliding, patient injury, or interference with moving parts of the bed.
• Do not use the support surface when gaps are present. The risk of entrapment can develop when the support surface is placed on non-compatible bed frames.
• 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.
CCAAUUTTIIOONN
• 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 put overlays or accessories inside the cover to avoid the risk of reducing pressure redistribution performance.
To setup the support surface:
1. Make sure that the support surface fits the bed frame.
2. Place the support surface with the artwork face up at the head end of the bed frame.
3. Make sure that the mattress is placed between the mattress retainers on the bed frame.
4. Place linens on the support surface per hospital protocols.
EN 8 2815-009-001 Rev D.1
OOppeerraattiioonn
TTrraannssffeerrrriinngg aa ppaattiieenntt ffrroomm oonnee ppaattiieenntt ssuuppppoorrtt ppllaattffoorrmm ttoo aannootthheerr
WWAARRNNIINNGG
• 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 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 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. (7.6 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:
PPrreerreeqquuiissiittee:: Follow hospital protocols required to transfer a patient from one 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 to 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.
2815-009-001 Rev D.1 9 EN
PPrreevveennttiivvee mmaaiinntteennaannccee
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 often based on your level of product usage.
Remove product from service before performing preventive maintenance.
NNoottee -- Clean and disinfect the exterior of the support surface before inspection, if applicable.
Inspect the following items for the standard models:
Zipper and covers (top and bottom) are free of tears, 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 Handles are free of rips or cracks and stitching is intact Foam has not degraded or come apart Fire barrier for rips, cracks, or other visible signs of damage
Inspect the following items for the behavioral health models:
Covers (top and bottom) are free of tears, cuts, holes, or other openings Labels for legibility, proper adherence, and integrity
Product serial number:
Completed by:
Date:
CClleeaanniinngg aanndd ddiissiinnffeeccttiinngg wwiitthh wwiippeess
For 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 ethylbenzyl ammonium chloride - 0.154%
Isopropanol - 21.000%
Non-active ingredient: Ethylene Glycol Monobutyl Ether – < 3%
NNoottee -- 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.
NNoottee
• 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.
EN 10 2815-009-001 Rev D.1
CCaarree aanndd mmaaiinntteennaannccee
WWAARRNNIINNGG
• Do not wash the internal components of this support surface. Discard the support surface if a contamination is found inside.
• Do not immerse the product in cleaning or disinfectant solutions.
• Do not allow liquid to pool on the product.
• 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 dry each product after you clean. Some cleaning agents are corrosive in nature and may cause damage to the product. Failure to follow these cleaning instructions may void your warranty.
CCAAUUTTIIOONN
• Do not allow liquid to seep into the zipper area or watershed cover barrier when you clean the underside of the support surface. Fluids allowed to come in contact with the zipper may leak into the support surface core.
• 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 dry the support surface covers before you store, add linens, or place a patient on the surface. A dry product helps to prevent impaired performance.
• Do not over expose the covers to higher concentration chemical solutions as these may degrade the covers.
• Do not use accelerated hydrogen peroxides or quaternaries that contain glcyol ether >3% as these chemicals may damage the support surface cover.
• Failure to follow manufacturing instructions may also affect useful life of the support surface cover.
The support surface cover is resistant to the following chemical solutions:
Quaternaries (active ingredient - ammonium chloride) that contain less than 3% glycol ether
Phenolic solution (Matar)
Chlorinated bleach solution (10000 ppm) for use with END406 mattress covers
Chlorinated bleach solution (1000 ppm) for use with Nylon mattress covers
70% isopropyl alcohol
Follow hospital protocol for support surface care between patients, to avoid the risk of cross-contamination and infection.
NNoottee -- Chlorinated bleach solution may cause discoloration of the Nylon mattress covers.
2815-009-001 Rev D.1 11 EN
QQuuiicckk rreeffeerreennccee rreeppllaacceemmeenntt ppaarrttss
These parts are available for purchase for the standard models, but subject to change. Call Stryker Customer Service: 1­800-327-0770 for available parts and prices.
NNaammee NNuummbbeerr
Cover assembly, heel slope, END406 80 in. 281505550012
Cover assembly, heel slope, END406, 84 in. 281505550014
Cover assembly, heel slope, Nylon 80 in. 281505550018
Cover assembly, heel slope, Nylon 84 in. 281505550016
CCoovveerr rreeppllaacceemmeenntt -- SSttaannddaarrdd mmooddeell
CCAAUUTTIIOONN -- Always take caution when you replace the support surface cover. The internal fire barrier contains fiberglass fibers. Dust particles from the fibers may cause skin irritation.
TToooollss rreeqquuiirreedd::
None
PPrroocceedduurree::
1. Raise the bed height to the full up position.
2. Lower the fowler and gatch sections to the full down positions.
3. Unzip the cover. Start at the foot end patient right corner of the support surface and stop at the head end patient right corner.
4. Fold the top of the cover to the patient’s right side and then remove the foam crib assembly from the bed and set aside.
5. Remove and discard the cover.
6. Place the replacement cover, unzipped and open, on the bed with the black bottom cover on the litter and the top cover folded over the patient’s right side of the bed.
7. 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.
8. Fold the top cover over the top of the foam crib assembly to make sure that the top cover is aligned with the foam crib assembly.
9. Zip the cover to close. Start at the head end patient right corner and stop at the foot end patient right corner.
10.Verify proper operation before you return the product to service.
EN 12 2815-009-001 Rev D.1
SSuuppeerrffiicciiee ddee ssooppoorrttee nnoo mmoottoorriizzaaddaa PPrrooFFoorrmm™
MMaannuuaall ddee uussoo
2815
2815-009-001 Rev D.1
ES
2019/04
SSíímmbboollooss


10
Consultar el manual/folleto de instrucciones
Instrucciones de utilización/Consultar las instrucciones de uso
Advertencia general
Precaución
Número de catálogo
Número de serie
Fabricante
Carga de trabajo segura
Lavar a mano
No secar en secadora
No limpiar a seco
No planchar
Dejar secar al aire
Lejía clorada
Para ver las patentes estadounidenses, visite www.stryker.com/patents
Mantener seco
No apilar más de 10 unidades
2815-009-001 Rev D.1 ES
Este lado hacia arriba
Frágil
No utilizar objetos afilados para abrir el paquete
Peso del equipo
ES 2815-009-001 Rev D.1
ÍÍnnddiiccee
Símbolos ..........................................................................................................................................................15
Definición de advertencia, precaución y nota ..................................................................................................2
Resumen de las precauciones de seguridad ............................................................................................2
Introducción .................................................................................................................................................4
Descripción del producto ........................................................................................................................4
Uso previsto ..........................................................................................................................................4
Vida útil prevista, estándar ......................................................................................................................5
Vida útil prevista, salud conductual..........................................................................................................5
Contraindicaciones.................................................................................................................................5
Especificaciones ....................................................................................................................................5
Estándar.........................................................................................................................................5
Salud conductual .............................................................................................................................6
Condiciones ambientales .................................................................................................................6
Información de contacto..........................................................................................................................7
Ubicación del número de serie ................................................................................................................7
Fecha de fabricación ..............................................................................................................................7
Instalación....................................................................................................................................................8
Funcionamiento............................................................................................................................................9
Transferencia de un paciente de una plataforma de soporte del paciente a otra ..........................................9
Mantenimiento preventivo............................................................................................................................10
Limpieza y desinfección con paños........................................................................................................10
Cuidado y mantenimiento .....................................................................................................................11
Referencia rápida a las piezas de repuesto................................................................................................... 12
Sustitución de la funda, modelo estándar ...............................................................................................12
2815-009-001 Rev D.1 1 ES
DDeeffiinniicciióónn ddee aaddvveerrtteenncciiaa,, pprreeccaauucciióónn yy nnoottaa
Las palabras AADDVVEERRTTEENNCCIIAA, PPRREECCAAUUCCIIÓÓNN y NNOOTTAA tienen un significado especial y deberán considerarse detenidamente.
AADDVVEERRTTEENNCCIIAA -- Advierten al lector sobre situaciones que, si no se evitan, podrían producir la muerte o lesiones graves. También pueden describir posibles reacciones adversas graves y peligros para la seguridad.
PPRREECCAAUUCCIIÓÓNN -- Advierten al lector sobre situaciones potencialmente peligrosas que, si no se evitan, pueden producir lesiones leves o moderadas al usuario o al paciente, o daños al equipo u otras propiedades. Incluyen cuidados especiales necesarios para el uso seguro y eficaz del dispositivo, y para evitar dañarlo con el uso o el mal uso.
NNoottaa -- Ofrecen información especial que facilita el mantenimiento o aclara instrucciones importantes.
RReessuummeenn ddee llaass pprreeccaauucciioonneess ddee sseegguurriiddaadd
Lea siempre las advertencias y precauciones indicadas en esta página, y sígalas escrupulosamente. Las reparaciones solo puede realizarlas personal cualificado.
AADDVVEERRTTEENNCCIIAA
• Nunca utilice la superficie de soporte del modelo estándar en entornos de salud conductual. La cremallera permite acceder a componentes internos que podrían utilizarse para producir daños.
• Compruebe siempre con regularidad la piel del paciente. Consulte a un médico si se produce un eritema o una lesión cutánea. Podrían producirse lesiones graves si no se trata la afección de la piel del paciente.
• Extreme las precauciones y la vigilancia para ayudar a reducir el riesgo de caída del paciente. La estabilidad del paciente y la protección que brindan las barras laterales pueden reducirse por el uso de un protector.
• Compruebe siempre si hay objetos extraños entre la superficie de soporte y el bastidor de la cama. Los objetos extraños pueden hacer que la superficie de soporte se deslice sobre la plataforma de soporte.
• Considere siempre el uso de las barras laterales. El uso seguro de la superficie de soporte se maximiza cuando se utiliza junto con las barras laterales. Cuando las barras laterales no están presentes, el riesgo de caída es mayor. Pueden producirse lesiones graves o la muerte debido al uso (posible atrapamiento) o al no uso (posibles caídas de pacientes) de las barras laterales o de otros elementos restrictivos. Tenga en cuenta las políticas locales sobre el uso de las barras laterales. El médico, el operador o las partes responsables deberán determinar si utilizar o no las barras laterales, y cómo hacerlo en función de las necesidades individuales de cada paciente.
• Tenga siempre más cuidado con los pacientes con riesgo de caer (como cuando están agitados o confusos) para reducir la probabilidad de una caída.
• No utilice la superficie de soporte sobre bastidores de cama más grandes o más pequeños que no coincidan en anchura, longitud o grosor. Esto es para evitar el riesgo de deslizamiento de la superficie de soporte, de lesiones en el paciente o de interferencia con las piezas móviles de la cama.
• No utilice la superficie de soporte cuando haya huecos. Cuando la superficie de soporte se coloque en bastidores de cama no compatibles, es posible que aumente el riesgo de atrapamiento.
• No pase agujas a través de la funda de la superficie de soporte. Los orificios pueden permitir el paso de líquidos corporales al interior (parte central interna) de la superficie de soporte, lo que podría causar contaminación cruzada y daños o mal funcionamiento del producto.
• No utilice la superficie de soporte como un dispositivo de transferencia.
• No utilice las agarraderas de la superficie de soporte para levantar o desplazar la superficie de soporte con un paciente encima.
• No supere la carga de trabajo segura del bastidor de la cama del hospital cuando sostenga al paciente y la superficie de soporte. El peso excesivo puede provocar resultados impredecibles en el funcionamiento y la seguridad de este producto.
• Asegúrese siempre de que las plataformas de soporte del paciente y sus correspondientes huecos de transferencia sean los adecuados para dar soporte al paciente. Si el hueco entre las dos plataformas de soporte del paciente es de más de 3 pulgadas (7,6 cm), utilice el puente de transferencia para rellenar el hueco. El puente de transferencia está diseñado para facilitar la transferencia de un paciente de una plataforma de soporte del paciente a otra.
• Para reducir el riesgo de caída del paciente, cuando coloque al paciente sobre la superficie de soporte, asegúrese siempre de que la barra lateral opuesta esté levantada.
ES 2 2815-009-001 Rev D.1
• No lave los componentes internos de esta superficie de soporte. Si encuentra contaminación en su interior, deseche la superficie de soporte.
• No sumerja el producto en soluciones de limpieza o desinfectantes.
• No deje que se acumule líquido sobre el producto.
• Antes de cada uso, inspeccione siempre las fundas (superior e inferior) de la superficie de soporte para detectar desgarros, perforaciones, desgaste excesivo y cremalleras mal alineadas. Si observa algún deterioro, retire del servicio de inmediato la superficie de soporte.
• Asegúrese siempre de limpiar todos los productos con agua limpia y de secarlos después de la limpieza. Algunos productos de limpieza son corrosivos por naturaleza y pueden provocar daños al producto. Si no se siguen estas instrucciones de limpieza, se podría anular la garantía del producto.
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• El uso inadecuado del producto puede provocar lesiones al paciente o al operador. Utilice el producto únicamente como se describe en este manual.
• No modifique el producto ni ninguno de sus componentes. La modificación del producto puede provocar un funcionamiento impredecible que, a su vez, cause lesiones al paciente o al operador. La modificación del producto también anula su garantía.
• Tenga siempre cuidado con los dispositivos o el equipo colocados sobre la superficie de soporte. La superficie podría dañarse debido al peso del equipo, el calor generado por este o sus bordes afilados.
• No coloque protectores ni accesorios dentro de la funda para evitar el riesgo de reducir el rendimiento de la redistribución de la presión.
• No permita que se filtre líquido por la zona de la cremallera ni por la barrera de la funda que protege a la cremallera de la entrada de líquidos cuando limpie la parte inferior de la superficie de soporte. Los líquidos que entren en contacto con la cremallera podrían pasar a la la parte central interna de la superficie de soporte.
• Las fundas de la superficie de soporte no pueden plancharse, limpiarse en seco ni secarse en una secadora de ropa.
• No lave a presión la superficie de soporte porque podría dañar el producto.
• Deje siempre que las fundas de la superficie de soporte se sequen antes de guardar la superficie de soporte, ponerle sábanas o colocar un paciente sobre ella. El secado del producto ayuda a evitar que su rendimiento disminuya.
• No exponga excesivamente las fundas a soluciones químicas muy concentradas, ya que estas pueden degradarlas.
• No utilice peróxidos de hidrógeno acelerados ni compuestos cuaternarias que contengan >3 % de éteres de glicol, ya que estos productos químicos podrían dañar la funda de la superficie de soporte.
• El incumplimiento de las instrucciones de fabricación también puede afectar a la vida útil de la funda de la superficie de soporte.
• Tenga cuidado siempre que sustituya la funda de la superficie de soporte. La barrera ignífuga interna contiene fibras de fibra de vidrio. Las partículas de polvo de las fibras pueden provocar irritación cutánea.
2815-009-001 Rev D.1 3 ES
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Este manual le ayudará a utilizar o mantener su producto de Stryker. Lea este manual antes de utilizar este producto o de realizar su mantenimiento. Establezca métodos y procedimientos para formar a su personal en el uso o el mantenimiento seguros de este producto.
PPRREECCAAUUCCIIÓÓNN
• El uso inadecuado del producto puede provocar lesiones al paciente o al operador. Utilice el producto únicamente como se describe en este manual.
• No modifique el producto ni ninguno de sus componentes. La modificación del producto puede provocar un funcionamiento impredecible que a su vez cause lesiones al paciente o al operador. La modificación del producto también anula su garantía.
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• Este manual es un componente permanente del producto y debe permanecer con él si se vende.
• Stryker busca continuamente el avance en el diseño y la calidad de sus productos. Este manual contiene la información sobre el producto más actualizada disponible en el momento de la impresión. Puede haber ligeras discrepancias entre su producto y este manual. Si tiene preguntas, póngase en contacto con el Servicio de Atención al Cliente o con el Servicio de Asistencia Técnica de Stryker, en el +1-800-327-0770 (llamada gratuita en EE. UU.).
DDeessccrriippcciióónn ddeell pprroodduuccttoo
PPrrooFFoorrmm™™ es una superficie de soporte de espuma no motorizada de 6 pulgadas (15,2 cm) de grosor para la población general de pacientes. La parte central interna del colchón tiene cortes de articulación. Las opciones del material de la funda del colchón incluyen material de nailon o tejido END406 de DDaarrtteexx®. Todas las configuraciones del producto incluyen inclinación de talón en el extremo de los pies de la superficie de soporte. Las dimensiones de este producto son compatibles con los bastidores de cama de SSttrryykkeerr. Consulte la lista de bastidores de cama compatibles en el apartado de especificaciones de este manual.
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PPrrooFFoorrmm utiliza espuma para facilitar la redistribución de la presión y la inmersión.
Este producto es una superficie de soporte no motorizada que ayuda a prevenir y tratar lesiones por presión o úlceras por presión (todas las fases, lesiones no clasificables y lesiones tisulares profundas). Le recomendamos que utilice este producto junto con la evaluación clínica de factores de riesgo y la evaluación cutánea realizadas por un profesional sanitario.
El modelo estándar (281505550001, 281505550003, 281505550005, 281505550007, 281505550020) está indicado para entornos hospitalarios generales, concretamente para los centros sanitarios de agudos.
El modelo de salud conductual (281505550009, 281505550010, 281505550011) está indicado para utilizarse en centros de salud conductual.
PPrrooFFoorrmm deberá utilizarse siempre con una funda para la superficie de soporte. La funda de la superficie de soporte puede interactuar con toda la piel externa. Este producto deberá utilizarse con una sábana encimera.
Los modelos estándar para entornos hospitalarios generales y los modelos de salud conductual no están indicados para:
Pacientes que superen la carga de trabajo segura
Pacientes bariátricos
Entornos sanitarios domésticos
No es un producto estéril
No incluye una función de medición
SSttrryykkeerr fomenta la evaluación clínica de cada paciente y el uso adecuado por parte del operador.
ES 4 2815-009-001 Rev D.1
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La parte central interna y las fundas de la superficie de soporte del PPrrooFFoorrmm tienen una vida útil prevista de 3 años en condiciones de uso normales y con el mantenimiento periódico adecuado.
VViiddaa úúttiill pprreevviissttaa,, ssaalluudd ccoonndduuccttuuaall
La superficie de soporte del PPrrooFFoorrmm tiene una vida útil prevista de 3 años en condiciones de uso normales y con el mantenimiento periódico adecuado. Este producto no tiene piezas que requieran servicio técnico.
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Ninguna conocida.
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500 libras 226,8 kg
Carga de trabajo segura
NNoottaa -- El paciente no deberá superar la carga de trabajo segura especificada para la superficie de soporte.
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MMooddeelloo ppaarraa ppaacciieennttee ggeenneerraall
Longitud 84 pulgadas 213,4 cm 80 pulgadas 203,2 cm
Anchura 35 pulgadas 88,9 cm 35 pulgadas 88,9 cm
Grosor 6 pulgadas 15,2 cm 6 pulgadas 15,2 cm
Peso del producto 30 libras 13,6 kg 29 libras 13,2 kg
Material de la funda superior
MMooddeelloo ppaarraa ppaacciieennttee ggeenneerraall
Longitud 84 pulgadas 213,4 cm 80 pulgadas 203,2 cm
Anchura 35 pulgadas 88,9 cm 35 pulgadas 88,9 cm
Grosor 6 pulgadas 15,2 cm 6 pulgadas 15,2 cm
Peso del producto 30 libras 13,6 kg 29 libras 13,2 kg
Material de la funda superior
228811550055555500000011 oo 228811550055555500002200 eenn bboollssaa 228811550055555500000033
END406 de DDaarrtteexx®
228811550055555500000055 228811550055555500000077
Nailon
2815-009-001 Rev D.1 5 ES
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