Related Manuals for SUNFLOWER Static Sapphire Series
Summary of Contents for SUNFLOWER Static Sapphire Series
- Page 1 User Manual Sapphire Series® Static™ Low-Air-Loss Mattress Replacement System #8083 Rev. 8.0 03.04.2021 User Manual...
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Page 2: Table Of Contents
Table of Contents Definition of Symbols ........................3 Manual Definitions ........................3 Warnings and Cautions ....................... 3 General Warnings and Precautions ....................5 Device Information ......................... 6 Description of the Device ......................6 Purpose of the Device ......................... 6 Indications for Use ........................6 Specifications .......................... - Page 3 Warranty Information ........................32 Return/Exchange Goods Policy: ....................32 Warranty Provisions: ........................ 32 User Assistance Information ......................33...
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Page 4: Definition Of Symbols
It is important to follow all instructions and special procedures to avoid electrical shock to the operator, care provider and/or patient. Manufacture Edison Testing European CE Manufacture Address Laboratories Logo Marking Date Ratings Federal Unit Grounding Sunflower Communications Specifications Medical Logo Commission... - Page 5 This symbol marks the location and specification of the fuse. Replace fuse as marked This symbol signifies that the device is properly protected from electrical shock. This symbol marks the location of the leakage test point screw. Power Cord Label The hazards and warnings indicated shipping container by this...
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Page 6: General Warnings And Precautions
General Warnings and Precautions WARNINGS WARNING: DO NOT use this device if the power cord is cut, frayed or loosely connected to the device. WARNING: (110V unit) Electrically Powered Mechanism. Electrical Hazard may occur if device is plugged into inadequate electrical outlet. To avoid electrical shock hazard, make sure unit is plugged into a grounded A/C 110V outlet. -
Page 7: Device Information
Device Information Description of the Device The two principle components of the SAPPHIRE SERIES® Static Low-Air-Loss Mattress Replacement System are a specialized air inflatable bladder (air mattress) and an electrically powered Blower / Control Unit. Purpose of the Device The purpose of the Sapphire Series® Static Low-Air-Loss Mattress Replacement System is to provide therapeutic benefit to patients at risk or suffering from pressure ulcers. -
Page 8: Specifications
Specifications Control Unit/Blower Mode of Use……………………………………………………………………………………….…. For Indoor Use Only Duty Cycle....…………………………………………………………………………………………..Continuous Controller Dimensions…………………….…….…..… (LxWxH) 6”(15 cm) x 16”(41 cm) x 10.5”(27cm) Controller Weight…………………………………………………………….…………………………… 11 lbs. (4.98 kg) Operating Temperature……………………………………………………………….. -18°C to 35°C (0°F to 95°F) ... -
Page 9: Unpacking And Set-Up Instructions
Unpacking and Set-Up Instructions Unpacking/Parts Breakdown The Sapphire Series® Static Low-Air-Loss Mattress Replacement System consists of a control unit, power cord, a clinically effective low air loss mattress and a waterproof, vapor permeable, easy-to-clean cover. Parts: Air Blower / Control Unit ... - Page 10 NOTE: Some cellular telephones, and similar devices, transmit signals while they are ON, even when not being used. Directions for Mattress Placement: Replace the existing bed mattress with the Sapphire Series® Static Low-Air-Loss Mattress Replacement System. Secure air mattress to the bed frame with straps provided. Warning or Safety Instructions Relating to Set-Up: WARNING: (110V unit ONLY) Ensure the power cord is plugged into a properly grounded AC 110V outlet.
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Page 11: Operating Instructions
Operating Instructions 1. Remove standard mattress from the frame. 2. Replace standard mattress with the Sapphire Series® Static Low-Air-Loss Mattress Replacement System. (Be sure air tubing is at the foot end of the frame.) 3. Strap air support mattress to the bed frame on all four sides. 4. - Page 12 3. Auto Fowler Attachment (optional) a. When elevating the head section of the mattress, Fowler mode will automatically turn on. Auto Fowler This is where the Auto Fowler attachment connects to the attachment control unit. 4. Lockout Feature a. After 3 minutes, if there are no changes to the blower settings, the lockout feature will activate.
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Page 13: Keypad Quick Reference
Keypad Quick Reference Alarm Silence – Lockout – Mutes the audible alarm. Locks all functions (Visual light will not turn off automatically after 3 mins. until failure is resolved.) To disable, press and hold lockout button for 3 sec. Firm – Soft –... -
Page 14: Patient Care Functions
Patient Care Functions Placing the Patient on the Mattress Surface Place the patient on the mattress surface from a bed or stretcher with a transfer device. The mattress should be set in the Auto Firm mode. In order to ensure proper immersion and envelopment of the patient, the user should: 1. -
Page 15: Prone Position
DO NOT leave a prone patient on the mattress surface. If the patient is unable to move without help, the patient’s airway may be compromised. If the patient is to be kept prone for an extended period of time, consult a Sunflower representative for assistance. Bedpan Placement & Removal Position the patient’s hips over the center of the mattress. -
Page 16: Mattress Cleaning Instructions
Mattress Cleaning Instructions WARNING and CAUTION: It is recommended that gloves and protective clothing be worn at all times during cleaning and disinfecting. DO NOT autoclave. NOTE: Improper cleaning, rinsing or the incorrect use of cleaning agents can lead to premature fabric discoloration and breakdown of the fabric’s fluid-resistance, stain-resistance and fabric strength. -
Page 17: Laundry Instructions
Clostridium difficile (C. diff) Prevention: Clorox Germicidal Wipes (Clorox Professional Products Company), EPA Reg. #67619-12 These pre-moistened wipes meet the CDC’s recommendations for Clostridium difficile (C.diff) bacteria, after the manufacturer’s recommended “wet contact time”. 1. Perform hand hygiene using soap and warm water, or hand sanitizer, and then put on disposable gloves and eye protection. - Page 18 Mattress Base: 1. Prepare the disinfectant according to the manufacturer’s recommendations. 2. Prepare a separate bucket of warm, fresh water to be used for rinsing the equipment after cleaning/disinfecting procedures are completed as instructed. 3. All surfaces of the mattress are to be wiped using a coarse cloth dampened with the disinfectant, prepared as directed by the manufacturer’s recommendations, to remove organic material and visible soil.
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Page 19: Cleaning Instructions: Control Unit/Blower
Cleaning Instructions: Control Unit/Blower NOTE: Hand clean only. DO NOT place in sterilization room or chamber. 1. Personal Protective Equipment should be used as directed by the Safety Data Sheet for the disinfectant. 2. Prepare the disinfectant according to the manufacturer’s recommendations. 3. -
Page 20: Maintenance
Maintenance CAUTION: The mattress requires regular maintenance to ensure performance and avoid premature wear, damage and injury. 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. -
Page 21: Hepa Filter
HEPA Filter HEPA: (High Efficiency Particulate Air) filter. NOTE: HEPA filters aid in contamination control for facilities. HEPA filters do not filter out gases and odor molecules such as chemical vapors and cigarette smoke. NOTE: HEPA filter must be used in conjunction with the manufacturer supplied foam filter. DO NOT attempt to install HEPA filter without the original equipment foam filter. - Page 22 HEPA Filter Maintenance NOTE: DO NOT MODIFY HEPA filter for installation. Order filter from Sizewise to receive filter with correct dimensions. NOTE: DO NOT attempt to clean HEPA filters, as they are to be removed and replaced only. − HEPA filters must be replaced monthly. −...
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Page 23: Storage And Disposal
DO NOT expose the blower unit to humidity greater than 95%. End-of life Sunflower Medical L.L.C products must be disposed of properly according to Local, State and Federal laws and regulations. If your product contains a battery and / or electronics components, disposal of those components must be completed separate from standard waste disposal. -
Page 24: Safety Tips
Safety Tips Important Safety Instructions Unpacking and Set-Up Instructions Keep out of direct sunlight. DO NOT expose to temperatures greater than 35°C (95°F) or below -18°C (0°F). DO NOT expose the Control Unit/Blower to humidity greater than 95%. ... -
Page 25: Electromagnetic Compatibility (Emc)
All pins of connectors have passed ESD testing. List of Cables and Accessories Replacement parts, such as cables and accessories, must be purchased through Sunflower Medical L.L.C. to ensure proper compliance requirements. WARNING: Using other manufacturers’ cables and accessories may affect EMC performance. - Page 26 Table 201 Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems This blower is intended for use in the electromagnetic environment specified below. The customer or user of the blower should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions...
- Page 27 Table 202 Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems This blower is intended for use in the electromagnetic environment specified below. The customer or user of the blower should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
- Page 28 Table 204 Guidance and Manufacturer’s Declaration – Immunity Equipment and Systems that are NOT Life-Supporting This blower is intended for use in the electromagnetic environment specified below. The customer or user of the blower should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
- Page 29 Table 206 Recommended Separation Distances between portable and mobile RF Communications equipment and blower. Equipment and Systems that are NOT Life-Supporting Recommended Separations Distances for the blower: The blower is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the blower can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the blower, as recommended below, according to the maximum output power of the communications...
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Page 30: Seven Zones Of Bed Rail Entrapment
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. -
Page 31: Troubleshooting
Check to be sure that unit is plugged in correctly. Unplug the control/blower Unit and check fuses located near the main ON/OFF switch. Replace as necessary. NOTE: If the troubleshooting process does not solve the problem please contact a Sunflower representative for service. -
Page 32: Frequently Ordered Parts
Frequently Ordered Parts The following is a list of parts that are frequently ordered for self-replacement and repairs. To aid in ordering parts, please use the provided product numbers given below for each part. The replacement of some parts not listed here may require sending in the unit to the manufacturer for repairs. - Page 33 Customer Service Department. Once RMA is issued, customer must return all item(s) placed on the RMA within five working days from the date of the RMA to Sunflower Medical LLC. Without an Authorized RMA, all item(s) will be returned to the customer at the customer’s expense.
- Page 34 User Assistance Information For questions or assistance with this product, contact Sunflower Medical L.L.C. at: Sunflower Medical L.L.C. 206 Jefferson Street PO Box 276 Ellis, Kansas 67637 Phone: 1-888-321-3382...
- Page 35 Phone: 1-888-321-3382 www.sunflowermedical.com Sunflower Medical L.L.C. and Sunflower Medical L.L.C. Rentals are trademarks of Sunflower Medical L.L.C. Rentals, L.L.C. All specifications, equipment and prices are subject to change without notice. Photos and drawings are representative of the products and may vary slightly...
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