Sizewise Evolution User Manual
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Sizewise Evolution User Manual

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Evolution®
User Manual
Doc. #8034, Rev. 12.0, Rev. Date: 3/01/2021
MFG-0020I-1219

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Summary of Contents for Sizewise Evolution

  • Page 1 Evolution® User Manual Doc. #8034, Rev. 12.0, Rev. Date: 3/01/2021 MFG-0020I-1219...

  • Page 2: Table Of Contents

    Warnings and Cautions ....................... 4 Important Safety Instructions ...................... 6 Device Information ........................11 Description of the SW Evolution™ ..................11 Description of the optional SW Rest Secure System™ (RSS) ..........11 Specifications ..........................12 SW Evolution™ Specifications ....................12 SW Rest Secure System™...
  • Page 3 Bed Exit Alarm: Use Alarm ....................32 Scale System: Use Scale and Access Weight History ............33 Protocol Timer: Using the Timer ..................34 Bed Exit Alarm: Set Alert Tones ..................35 Bed Exit Alarm: Record Message..................35 Scale System: Adjust Weight....................36 Scale System: Change LBS/KGS Setting ................
  • Page 4 Troubleshooting ..........................64 SW Evolution™ Troubleshooting .................... 64 SW Rest Secure System™ Troubleshooting ................65 Warranty Information ........................66 Sizewise Rentals™, LLC (Sizewise) Limited Warranty ............66 Manufacturer Disclaimer ......................68 User Assistance Information ......................69...

  • Page 5: Definition Of Symbols

    Definition of Symbols Manual Definitions Throughout this manual different type fonts and icons are used to aid user readability and understanding of the content. Below are some examples. Standard Text Used for regular information. Bold Face Text Emphasizes a word or phrase. NOTE SETS APART SPECIAL INFORMATION OR IMPORTANT INSTRUCTION CLARIFICATION.
  • Page 6 Symbol for Type B applied parts indicating protection provided against electric shock. The pinch point is spacing between movable parts of the device which, in positions of normal use fail to maintain a clearance of ≤ 8mm or ≥ 25mm. The hazards and warnings indicated shipping container by this...

  • Page 7: Important Safety Instructions

    For user and patient safety, read and follow all warnings and instructions that apply to use of the SW Evolution™. Before using this bed, the user must know what to do to ensure safety. Put the patient at ease. The care provider should communicate with the patient by telling them what they are planning to do.
  • Page 8  A fall may occur if side rail bolts are not secured properly or not in place causing harm to the patient and/or care provider.  Electric shock may occur when plugging the SW Rest Secure System™ into the wall outlet.
  • Page 9 Bed rail entrapment is a serious health risk that can result in serious injury or even death. Sizewise recommends the care provider be mindful of the FDA guidelines relevant to bed rail entrapment, as serious injury can result. These guidelines can be found on the FDA website.
  • Page 10  It is very important to read the information regarding the possible effects of electromagnetic interference on the SW Evolution™ and Rest Secure System™.  The bed is to be used in accordance with each facility’s policies and procedures.
  • Page 11  Many of the screws and bolts used in the bed are special high-strength fasteners. Contact an authorized Sizewise technician to assist if finding the correct fasteners. If improper fasteners are used, they could result in patient and/or user injury as well as damage to equipment or other property.

  • Page 12: Device Information

    Device Information Description of the SW Evolution™ The SW Evolution™ is an electric bed. Its purpose is to assist the care provider by reducing the chance or fall or serious injury without the use of physical or chemical restraints. positioning nature of this bed also provides care providers the convenience in attending to the patients.

  • Page 13: Specifications

    Specifications SW Evolution™ Specifications Quality Assurance Standards ............. CSA C22.2 No. 601.1 IEC/EN 60601-2-38 IEC/EN 60601-1 IEC 60601-1-2 Degree of Protection Against Electric Shock ............Type B Degree of Protection Against Ingress of Water ............IPX4 Electrical Rating............120VAC 60Hz, 4 amps (US model) 230VAC 50/60Hz, 4 amps (non-US models) Duty Cycle ............
  • Page 14 Weight Capacity -Bed ................. 850 lbs. / 385 kg Optional IV Pole ..............50 lbs. / 22 kg Optional Trapeze ............850 lbs. / 385 kg (Exceeding these limits will void the warranty) With Optional Trapeze Attached to Bed Height from Floor ............... 67.5” – 90.5” / 95 cm – 230 cm WARNING: Exceeding the weight capacity and/or working load listed in the specifications could result in patient or user injury as well as damage to equipment or other property.

  • Page 15: Sw Rest Secure System™ Specifications

    SW Rest Secure System™ Specifications Control Module The Control Module is located under the bed. Housing Material ....................ABS, UL94-V0 rated Width......................7.25” / 18.5 cm Length ......................3.25” / 8.5 cm Thickness ......................2.00” / 5 cm Connectors Power ....................2.1 mm Center Positive Load Cell ......................

  • Page 16: Hand Control

    Hand Control The Hand Control is located on the footboard. Housing Material ....................ABS, UL94-V0 rated Width....................... 3.00” / 7.5 cm Length ......................7.00” / 18 cm Thickness ......................1.75” / 4.5 cm Connectors CAN Network ...................... 6 pin RJ11 Operating Current Normal ........................

  • Page 17: Unpacking And Set-Up Instructions

    Unpacking and Set-Up Instructions SW Evolution™ Unpacking and Set-Up Unpacking/Parts Breakdown Inspect for any signs of freight damage. If obvious damage is detected, contact the freight company and file a damage complaint. It may be necessary to take pictures of the damage.

  • Page 18: Bed Set-Up

    Bed Set-Up 1. Remove side rails from under the bed. Remove packaging wrapped around the side rails and inspect for damages. The head section is placed upside down on the foot section. The headboard and footboard are placed between the two sections.
  • Page 19 5. Plug in power cord, foot control, hand control and battery cord into the appropriate outlets. 6. Plug in actuator cable to the appropriate marked outlets on the control box. 7. Attach the two sections with a 3/16” Allen wrench. Put the bolts in through the sections with...

  • Page 20: Headboard And Footboard Set-Up

    9. Plug the bed into a 120V AC grounded outlet. At this point, the bed should be fully functional. Using the hand control, check the function of each button to make sure the bed is functioning correctly. If for some reason the bed is not working, review these steps while...

  • Page 21: Side Rail Set-Up

    Bed rail entrapment is a serious health risk that can result in serious injury or even death. Sizewise recommends the care provider be mindful of the FDA guidelines relevant to bed rail entrapment, as serious injury can result.

  • Page 22: Sw Rest Secure System™ Set-Up

    SW Rest Secure System™ Set-Up Basic Set-Up WARNING: Electric shock may occur when plugging the SW Rest Secure System™ into the wall outlet. Use ONLY grounded or hospital grade outlets. DO NOT use the SW Rest Secure System™ if the power cord is cut, frayed or loosely connected to the bed.

  • Page 23: Bed Exit Alarm: Alert Type

    Bed Exit Alarm: Alert Type The nurse call is always active no matter what selection is made. When selecting nurse call only, the audio alert will be disabled in the room. This unit will chime on an alarm if a voice message has not been recorded and the unit is set to Voice Recording.

  • Page 24: Scale System: Adding/Removing Items

    Scale System: Adding/Removing Items The feature will allow items to be added and removed such as blankets or pillows from the bed without affecting the current weight reading of a patient. 1. Access the Menu by pressing the UP or DOWN arrow until ADD/REMOVE ITEMS is highlighted and then press ENTER.

  • Page 25: Protocol: Set Alert Reminder

    Protocol: Set Alert Reminder The protocol reminder is a timer that can be set for 1, 2 or 4 hours as a reminder that the patient needs to be attended to or checked on. There are three alert settings for the protocol alarm. 1.

  • Page 26: Setting The Time/Date

    Setting the Time/Date 1. Access the Menu by pressing the UP or DOWN arrow until SYSTEM SETTINGS is highlighted and then press ENTER. 2. Select SET TIME/DATE and then press ENTER. 3. Using the UP or DOWN arrow, the user can set the hours and then press ENTER.

  • Page 27: Resetting To Factory Variables

    SW Rest Secure System™ Default Settings: Resetting to Factory Variables It is important to reset to the factory defaults, before placing a different patient in the bed. This routine is typically performed during quality control checks or during routine service. Resetting defaults should also be performed, if the PC board in either the RSS control box or the RSS hand control has been replaced, or if the firmware has been updated (see the section SW Rest Secure System Updating Firmware on page 170 in the Technical Manual for SD card location).
  • Page 28 4. Using the UP or DOWN arrows on the keypad, select Y for Yes and then press ENTER. If you select N for No, you will be returned to the Home Screen without resetting the defaults. 5. The unit is now resetting the defaults and will return to the Home Screen when complete.

  • Page 29: Operating Instructions

    Operating Instructions SW Evolution™ Operating Instructions Foot Controls The foot controls are located at the foot end of the bed. The controls have individual lock out functions as well as a master lock out switch. Locking out the specific function or all functions will disable the function on the hand control and foot controls.

  • Page 30: Operation Of Bed

    The buttons perform the following operations: A. Raises the head section B. Lowers the head section C. Raises the bed D. Lowers the bed E. Gatches the knees F. Lowers the knees G. Trendelenburg (feet higher than head) H. Reverse Trendelenburg (head higher than feet) Operation of Bed WARNING: Failure to heed the warnings pertaining to the operation of the bed...
  • Page 31 This bed is not intended for use in high moisture areas (e.g. showers, pool therapy), or extreme temperature environments. Use only parts, accessories and adapters authorized by the manufacturer. DO NOT use the bed with any unintentionally missing or abnormal parts. Remove the hand control when the patient is unattended.

  • Page 32: Rest Secure System Operating Instructions

    Rest Secure System Operating Instructions Hand Control The hand control has glow-in-the-dark features; in case of power outages operation is not impaired. A. LCD Display – Lighted display shows the weight and allows the navigation of on-screen menus. B. Microphone – Use to record a message for the voice alarm. C.

  • Page 33: Bed Exit Alarm: Use Alarm

    Bed Exit Alarm: Use Alarm The bed exit alarm function on the SW Rest Secure System™ alerts the care provider that a patient is attempting to exit the bed or is in an immediate risk of falling. This is especially important in settings where continuous surveillance of the patient is not feasible.

  • Page 34: Scale System: Use Scale And Access Weight History

    NOTE: The bed exit indicator light will blink for 10 seconds before the alarm will activate. Upon activation, the indicator will stay on. The bed exit alarm can only be activated with a minimum of 35 lbs. (16 kg) on the bed. Scale System: Use Scale and Access Weight History The Rest Secure System’s integrated scale helps reduce the risk of care provider or patient injury by allowing care providers to accurately record the weight of the patient without having to...

  • Page 35: Protocol Timer: Using The Timer

    Protocol Timer: Using the Timer The SW Rest Secure System™ protocol timer can be utilized to alert the care provider that the patient needs to be attended to or checked on at intervals of 1, 2 or 4 hours. The protocol timer has the capability to alert the care provider by an audible tone on the unit and, if connected to the Nurse Call Interface, can activate the nurse call signal.

  • Page 36: Bed Exit Alarm: Set Alert Tones

    Bed Exit Alarm: Set Alert Tones There are 5 different audible alarm tones for the bed exit alarm. The user will hear each of the different tones as they scroll through the 5 selections. 1. Access the Menu by pressing the UP or DOWN arrow until Bed EXIT SETTINGS is highlighted and then press ENTER.

  • Page 37: Scale System: Adjust Weight

    Scale System: Adjust Weight This feature is designed to manually adjust the weight if items were added to the bed without using the Add/Remove option. The user will need to make sure the patient’s weight is known before using this option. 1.

  • Page 38: Scale System: Locking/Unlocking The Unit In Lbs/Kgs

    Scale System: Locking/Unlocking the Unit in LBS/KGS As part of a safety feature, this unit has the ability to lock the unit of measure in lbs. or kgs. This will prevent accidently changing the units in the Scale Settings menu. 1.

  • Page 39: Proper Use Of The Bed

    Proper Use of the Bed WARNING: Follow the instructions for assisting patients in and out of the bed to avoid a fall or injury to the patient and/or care provider. To get in the bed, position the bed at the proper height by following these steps: 1.

  • Page 40: Side Rails

    Bed rail entrapment is a serious health risk that can result in serious injury or even death. Sizewise recommends the care provider be mindful of the FDA guidelines relevant to bed rail entrapment, as serious injury can result.

  • Page 41: Transfers

    The side rails are not designed to bear the full weight of the patient. The safe working load for each side rail has been determined to be 150 lbs. (68 kg). The side rails were tested to 60601-2-38 (28.4.102 and 28.4.103). These rails also have been tested and comply with patient entrapment rules and regulations (23.101).

  • Page 42: Features

    Features Casters Steer Casters At the foot section there are lock and steer casters. When locked the bed can still maneuver but the casters will not swivel, this makes them the steering casters. Press down on the pedal to lock and lift up on the pedal to unlock. When one pedal on the head section caster is pressed or lifted both head section casters will be activated.

  • Page 43: Emergency Battery Backup

    Emergency Battery Backup In case of power failure the emergency battery backup will operate the bed. Use only in emergency situations, the battery backup is not designed for continuous use. The battery will recharge itself while the bed is plugged into a hospital grade or grounded outlet. This bed is equipped with two 5 amp 12V sealed lead-acid (gel) batteries (total 24V).

  • Page 44: Serial Number Location

    Serial Number Location The bed has a manufacturer serial number, and a Sizewise Rentals LLC serial number. The serial numbers are located at the foot of the bed.
  • Page 45 Tools required for assembly: 2-9/16” wrenches 1. Attach the end posts into the appropriate brackets on the head and foot sections of the bed. 2. Place the overhead beam into the slots on top of each end post. NOTE: Be sure to place the holes facing upward on the overhead beam. 3.

  • Page 46: Seven Zones Of Bed Rail Entrapment

    If the patient would have any clinical conditions that could result in risk of falling or improperly lying in bed, the bed should be left at its lowest setting and in flat position when not attended. Sizewise recommends the use of bed rails if they are available. There are seven zones of bed rail entrapment.
  • Page 47 This bed complies with IEC 60601-2-38 standard for bed rail entrapment. Below are the specifications of that standard. This was taken from the 60601-2-38 Amend. 1 IEC 1999. DESIGNATOR DESCRIPTION DIMENSION ≤ 120 mm Smallest dimension between elements inside the perimeter of the SIDE RAIL in its raised/locked positions or perimeters created between the SIDE RAIL and fixed parts of the BED.

  • Page 48: Safety Tips

    WARNING: Medical equipment should not be used, stacked or located on or around equipment that may create electromagnetic interferences. Emissions The SW Evolution™ and SW Rest Secure System™ have been type tested and have passed the requirements of CISPR 11. Observe the following recommendations to minimize radio frequency emissions in this section and the Electromagnetic Interference section.
  • Page 49 RoHS Compliant Electromagnetic Interference (EMI) The SW Evolution™ and SW Rest Secure System™ have been tested and are intended for safe use with other components compliant to IEC 601 standards for medical devices. The SW Evolution™ and SW Rest Secure System™ can cause interference with non-601 regulated equipment and/or other non-601 regulated equipment can cause interference with the SW Evolution™...

  • Page 50: Electromagnetic Interference (Emi) From Radio Wave Sources

    System™. Electromagnetic Interference (EMI) from Radio Wave Sources The SW Evolution™ and SW Rest Secure System™ have been tested and are intended for safe use with other components compliant to IEC 601 standards for medical devices. The SW Evolution™ and SW Rest Secure System™ may be susceptible to electromagnetic interference...
  • Page 51 Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that are NOT Life-Supporting The SW Evolution™ and SW Rest Secure System™ are intended for use in the electromagnetic environment specified below. The customer, or user, of the bed should ensure that it is used in such an environment.
  • Page 52 Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems The SW Evolution™ and SW Rest Secure System™ are intended for use in the electromagnetic environment specified below. The customer, or user, of the SW Evolution™ and SW Rest Secure System™ should ensure that it is used in such an environment.
  • Page 53 Guidance and Manufacturer’s Declaration – Immunity Equipment and Systems that are NOT Life-Supporting The SW Evolution™ and SW Rest Secure System™ are intended for use in the electromagnetic environment specified below. The customer, or user, of the bed should ensure that it is used in such an environment.

  • Page 54: General Safety

    Recommended Separations Distances for the SW Evolution™ and Rest Secure System™: The SW Evolution™ and SW Rest Secure System™ are intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer, or user, of the SW Evolution™...

  • Page 55: Pinch Point

    Pinch Point Watch for pinch points on the bed, which are indicated by the pinch point label. HAZARD: Pay close attention to pinch points on the bed to avoid injury to the patient and/or care provider. Pinch points have minimal clearances between two moving parts that fail to maintain a clearance of ≤...

  • Page 56: Transport

    Transport WARNING: During transport, use caution so the bed does not tip or overbalance. Failure to do so could result in patient and/or user injury as well as damage to equipment or other property. CAUTION: The bed needs to be stored, transported and operated in a temperature range of -5°C to 45°C (23°F to 113°F).

  • Page 57: Cleaning Instructions

    Cleaning Instructions WARNING: Before cleaning the bed, be sure to disconnect it from the wall outlet (power source). Failure to do so could result in electrical shock and could result in patient and/or user injury as well as damage to equipment or other property.
  • Page 58 General Patient Room Cleaning/Disinfecting Personal Protective Equipment should always be used as directed by the Material Safety Data Sheet for the disinfectant. Prepare the disinfectant according to the manufacturer’s recommendations. Prepare a separate bucket of warm, fresh water to be used for rinsing the equipment after cleaning/disinfecting procedures are completed as instructed.
  • Page 59 Steam Cleaning This product may be steam cleaned to eliminate bacteria and/or bed bug infestations, if desired. When applying steam, avoid areas such as electrical connections and components including scale meters, scale system components, hand and/or footboard controls that may be damaged by being exposed to excessive moisture and/or heat.
  • Page 60 Sleep Surfaces (Including Mattress Bases and Top Covers) NOTE: The use of bleach-based products/solutions will provide a higher concentration of the agent than is required to eliminate the bacteria and will increase the potential for damage to the fabric and the built-in protective barrier to fluid of the sleep surface. NOTE: To reduce the discoloration of the sleep surface lining, surfaces must be thoroughly rinsed with clean, fresh water to remove chemical residues immediately after the required “wet contact time”...

  • Page 61: Laundry Instructions

    7. Rinse all surfaces of the control unit with fresh water and use a clean cloth to remove chemical and organic residue. 8. After cleaning, all surfaces are to be dried with a clean, dry cloth. Control unit air filters must be cleaned weekly. Replacement of the control unit air filter is recommended every 6 months.

  • Page 62: Optional Accessories

    Optional Accessories Battery Backup Units Turn OFF and disconnect the battery backup unit from all electrical power to avoid electrical shock. All surfaces of the battery backup unit and the power cord are to be wiped using a coarse cloth, dampened with the disinfectant solution, prepared as directed by the manufacturer’s recommendations, to remove organic material and visible soil.

  • Page 63: Maintenance

    Check the items on this chart at the indicated intervals. If any of the items are loose, worn, bent or distorted, immediately have them checked and/or repaired by an authorized Sizewise Technician. Frequent maintenance and servicing will improve performance between each use and extend bed life.

  • Page 64: Fasteners

    If improper fasteners are used, they could result in patient and/or user injury as well as damage to equipment or other property. Improper fasteners may fail. Use only screws and bolts provided by an authorized Sizewise representative.

  • Page 65: Troubleshooting

     If the bed will not operate off of battery power, plug the bed into a power source and let charge for 24 hours.  Ensure all cables to the Electronic Control Module are properly connected and secure. NOTE: If the troubleshooting process does not solve the problem please contact a Sizewise representative for service.

  • Page 66: Sw Rest Secure System™ Troubleshooting

    SW Rest Secure System™ Troubleshooting CAUTION: Only authorized personnel should engage in the troubleshooting process. Troubleshooting by unauthorized persons could result in personal injury or equipment damage. Display on handheld shows Load Cell Error or yellow light flashing on CPU box under the bed: ...

  • Page 67: Warranty Information

    Product No. 33060400 35" & 33060450 39" Limited Product Warranty PLEASE READ THESE WARRANTY TERMS AND CONDITIONS CAREFULLY BEFORE USING YOUR SIZEWISE PRODUCT. BY USING THE PRODUCT, YOU ARE CONSENTING TO BE BOUND BY THE FOLLOWING WARRANTY TERMS AND CONDITIONS. LIMITED WARRANTY.
  • Page 68 This Limited Product Warranty shall not apply to, and Sizewise shall have no obligation to make repairs, replace or correct products including any part or parts of the product as the result of Sizewise’s determination of any of the following:...

  • Page 69: Manufacturer Disclaimer

    (A) ANY OBLIGATION, LIABILITY, RIGHT, CLAIM OR REMEDY IN TORT, WHETHER OR NOT ARISING FROM THE NEGLIGENCE OF SIZEWISE OR ITS SUPPLIERS (WHETHER ACTIVE, PASSIVE OR IMPUTED); AND (B) ANY OBLIGATION, LIABILITY, RIGHT, CLAIM OR REMEDY FOR LOSS OF OR DAMAGE TO ANY PRODUCT OR PART(S). THIS DISCLAIMER AND RELEASE SHALL APPLY EVEN IF THE EXPRESS WARRANTY SET FORTH ABOVE FAILS OF ITS ESSENTIAL PURPOSE.

  • Page 70: User Assistance Information

    Sizewise Evolution Bed Product No. 33060400 35" & 33060450 39" Limited Product Warranty To make a warranty claim, contact: Complete this portion and keep for your records. Limited Product Warranty D-L00-001...
  • Page 71 Lenexa, KS 66215 800-814-9389 sizewise.com Sizewise is a registered trademark of Sizewise Rentals, LLC. All specifications, equipment, and prices are subject to change without notice. Photos and drawings are representative of the products and may vary slightly from actual production models.

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