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Summary of Contents for Sizewise Sapphire 1100
- Page 1 Sapphire 1100™/1100 EC™ User Manual Doc. #: ________ Rev. Date: _________ Rev.: _______ 8085 3/10/2022 11.0 1100, 1100EC User Manual MFG-0021T-0921...
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Page 2: Table Of Contents
Table of Contents Definition of Symbols ........................3 Manual Definitions ........................3 Warnings and Cautions ........................ 3 Device Information ........................... 5 Description of the Device ......................5 Purpose of the Device ........................5 Indications for Use ........................5 Specifications ........................... 6 Unpacking and Set-Up Instructions .................... - Page 3 Cleaning Blood and Other Excretions: ..................21 Control Unit Cleaning Instructions: ................... 22 Safety Tips ............................23 Seven Zones of Bed Rail Entrapment ..................23 Storage and Disposal ........................24 Important Safety Instructions ......................24 Electromagnetic Compatibility (EMC) ..................25 Troubleshooting ..........................
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Page 4: Definition Of Symbols
MADE IN USA Equipment Type B 3101425 Legal Manufacturer: Medical Electrical Equipment Raye’s, Inc. d/b/a Sizewise Manufacturing Conforms to: AAMI Std. ES60601-1, IEC Std. 60601-1-6 206 Jefferson Street Ellis, KS 67637 Certified to: CSA std. C22.2 No. 60601-1 Model: Serial #:... - Page 5 Power Cord Label WARNING/ATTENTION ELECTRICAL SHOCK HAZARD WARNING: Ne pas le boîtier ouvert. Do not open case. Do not open case for risk of electrical shock. Risque de choc Risk of electrical shock électrique et de lésions and bodily harm from corporelles des pièces moving parts.
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Page 6: Device Information
Device Information Description of the Device Clinically Effective Low Air Loss Mattress System is SAPPHIRE SERIES® 1100 & 1100EC comprised of a specialized inflatable air bladder (air mattress) and an electrically powered Control/Blower Unit. Purpose of the Device The purpose of the Clinically Effective Low Air Loss SAPPHIRE SERIES®... -
Page 7: Specifications
Specifications SAPPHIRE SERIES® 1100 & 1100EC Control Unit 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 8: Unpacking And Set-Up Instructions
Unpacking and Set-Up Instructions The two principle components of the Sapphire Series 1100 & 1100EC Mattress Replacement ® System are a specialized air inflatable bladder (Air Mattress) and an electrically powered, Air Control Unit. Unpacking / Parts Breakdown: Parts: Control Unit Detachable Power Cord (Hospital Grade) Clinically Effective Low Air Loss Mattress Replacement Mattress Cover... - Page 9 Beware of Electromagnetic Interference from Radio Wave Sources such as: Hand-held portable transceivers with the antenna mounted directly to the transmitting unit including citizen band (CB) radios, “walkie-talkies, security, fire and police transceivers, cellular telephones and other personal communication devices. NOTE: Some cellular telephones and similar devices transmit signals while they are ON, even when not being used.
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Page 10: Operating Instructions
Operating Instructions The Sapphire Series 1100, 1100EC & the Optional 39/48 Expandable Mattress Replacement ® System can be placed on any conventional bed used in hospitals, nursing homes or a home medical bed. The original bed mattress should be removed and stored in an appropriate place. The following steps should be completed in installing the system: 1. -
Page 11: Optional Expandable
Optional Expandable By attaching the connectors within the tubing connecting to the control unit the mattress expands from 39” (100cm) to 48” (120cm). 1100, 1100EC User Manual... -
Page 12: Fowler Mode
Fowler Mode g. When elevating the head section of the mattress, press the Fowler button to increase airflow for seat inflation. Auto Fowler attachment (Optional) h. When elevating the head section of the mattress, Fowler mode will automatically turn on. Auto Fowler attachment This is where the Auto Fowler attachment connects to the control unit. -
Page 13: 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 14: Prone Position
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 &... -
Page 15: Keypad Quick Reference
Keypad Quick Reference 1100, 1100EC User Manual... - Page 16 This chart is to be used as a reference ONLY. Final patient settings must be completed by the patient’s caregiver. 1100, 1100EC User Manual...
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Page 17: 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 and extend product life. -
Page 18: 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 19 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 filter must be replaced monthly.
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Page 20: 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 21: Mattress Top Cover
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 22: Mattress Base
After washing, the mattress top cover is to be air dried or dried in a dryer at very low or no heat to protect it from heat related damage. Mattress Base: 1. Prepare the disinfectant according to the manufacturer’s recommendations. 2. -
Page 23: Control Unit Cleaning Instructions
Control Unit Cleaning Instructions: NOTE: Hand clean only. DO NOT place in sterilization room or chamber. 1. Personal Protective Equipment should be used as directed by the Material Safety Data Sheet for the disinfectant. 2. Prepare the disinfectant according to the manufacturer’s recommendations. 3. -
Page 24: Safety Tips
WARNING: 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 25: Storage And Disposal
Storage and Disposal Keep the mattress in a clean dry area, away from heat or flames. Store the unit and mattress in a temperature range between 0°F (-18°C) and 95°F (35°C). Always store the surface flat on a clean, level surface. Avoid storage of other equipment on top of the support surface. DO NOT expose the control unit to humidity greater than 95%. -
Page 26: Electromagnetic Compatibility (Emc)
Electromagnetic Compatibility (EMC) The Sapphire Series 1100 & 1100EC has been tested for compliance with the EMC ® requirements. The guidelines in this section will help to ensure the medical equipment will meet the requirements of the standard WARNING: Medical equipment should not be used, stacked, or located on or around equipment that may create electromagnetic inferences Emissions This blower has been type tested and has passed the requirements of CISPR 11. - Page 27 Table 201 Guidance and Manufacturer's Declaration - Emissions All Equipment and Systems The blower is intended for use in the electromagnetic environment specified below. The customer or user of this blower should ensure that it is used in such an environment. Emissions Compliance Electromagnetic Environment Guidance...
- Page 28 Table 202 Guidance and Manufacturer's Declaration - Immunity All Equipment and Systems The 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 IEC 60601 Compliance Electromagnetic Environment...
- Page 29 Table 204 Guidance and Manufacturer's Declaration - Immunity Equipment and Systems which are NOT Life-supporting The 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 IEC 60601 Test Compliance...
- Page 30 Table 206 Recommended Separation Distances between portable and mobile RF Communications equipment and the blower. Equipment and Systems which are NOT Life-supporting Recommended Separation Distances for the blower The blower is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
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Page 31: Troubleshooting
Troubleshooting CAUTION: Only authorized personnel should engage in the troubleshooting process. Troubleshooting by unauthorized persons could result in personal injury or equipment damage. WARNING: To avoid electrical shock, DO NOT open the control unit. Refer servicing to qualified personnel only. If mattress is not inflating: ... -
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: Warranty Information
Product No. 61350005 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. THE WARRANTY GIVES BUYER SPECIFIC LEGAL RIGHTS, AND BUYER MAY ALSO HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE WARRANTY PERIOD AND COVERAGE. - Page 34 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 35 (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 36 1100 & 1100 EC Sizewise Mattress System Product No. 61350005 Limited Product Warranty To make a warranty claim, contact: Complete this portion and keep for your records. Limited Product Warranty D-L00-001 1100, 1100EC User Manual...
- Page 37 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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