Sizewise Sapphire 1100 User manual

Sapphire 1100™/1100 EC™
User Manual
Doc. #: ________ Rev. Date: _________ Rev.: _______
MFG-0021T-0921
1
1100, 1100EC User Manual
11.0
3/10/2022
8085

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 ................................................................................................. 7
Unpacking / Parts Breakdown ...................................................................................................... 7
Operating Instructions ...................................................................................................................... 9
Modes of Operation ...................................................................................................................... 9
Static Mode ................................................................................................................................... 9
Alternating Mode ......................................................................................................................... 9
Optional Expandable .................................................................................................................. 10
Fowler Mode .............................................................................................................................. 11
Auto Fowler attachment ............................................................................................................. 11
Lock-out Feature ........................................................................................................................ 11
Patient Care Functions .................................................................................................................... 12
Placing the Patient on the Mattress Surface ............................................................................... 12
Positioning the Patient ................................................................................................................ 12
Backrest Up or Fowler Position ................................................................................................. 12
Prone Position ............................................................................................................................. 13
Bedpan Placement & Removal ................................................................................................... 13
Removing the Patient from the Mattress Surface ....................................................................... 13
Keypad Quick Reference ................................................................................................................ 14
Maintenance ................................................................................................................................... 16
HEPA Filter ................................................................................................................................ 17
Mattress Cleaning Instructions ....................................................................................................... 19
Mattress Top Cover: ................................................................................................................... 20
Laundry Instructions: ................................................................................................................. 20
Mattress Base: ............................................................................................................................ 21
Air Therapy Internal Mattress Components: .............................................................................. 21
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1100, 1100EC User Manual

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 .............................................................................................................................. 30
Frequently Ordered Parts ................................................................................................................ 31
Warranty Information ..................................................................................................................... 32
Return/Exchange Goods Policy: .................................................................................................... 32
Warranty Provisions: ...................................................................................................................... 32
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1100, 1100EC User Manual

Definitions and Symbols
Definitions
Throughout this manual different type fonts and symbols 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.
Symbols
Electrical Shock Hazard Warning: This symbol is intended to alert the user to the presence of electrical
shock hazards. It’s important to follow all instructions and special procedures to avoid electrical shock to the
operator, care provider and/or patient.
Warnings/Cautions: This symbol is intended to alert the user to the presence of important operating,
maintenance or servicing instructions. Disregarding a warning could result in patient and/or user injury as
well as damage to equipment.
Manufacturer’s Label
UDI Information on separate label located on product near this label.
Indoor Use Only
MADE IN USA
3101425
Type B
Class I
Electrical
Equipment
Medical Electrical Equipment
Conforms to: AAMI Std. ES60601-1, IEC Std. 60601-1-6
Certified to: CSA std. C22.2 No. 60601-1
Legal Manufacturer:
Raye’s, Inc. d/b/a Sizewise Manufacturing
206 Jefferson Street Ellis, KS 67637
Model:
Serial #:
Manufacture Date:
Duty Cycle:
Electrical Rating:
27510711 Rev. 5.0
Lisez et comprenez entièrement
le manuel avant utilisation. Le
non-respect des instructions
d’utilisation peut entraîner la
mort ou des blessures graves.
Read and fully understand
manual before operating.
Failure to follow operating
instructions could result in
death or serious injury.
27008710, Rev. 1.0
Warning/Attention
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1100, 1100EC User Manual

Power Cord Label
Do not open case.
Risk of electrical shock
and bodily harm from
moving parts.
Ne pas le boîtier ouvert.
Risque de choc
électrique et de lésions
corporelles des pièces
en mouvement.
Read operator’s manual
before use. Important
safety and use
instructions provided.
Lire le manuel avant
utilisation opérateurs.
Consignes de sécurité
importantes et
l’utilisation prévue.
WARNING/ATTENTION
27509004, Rev. 4.0
ELECTRICAL SHOCK HAZARD WARNING:
Do not open case for risk of electrical shock.
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1100, 1100EC User Manual

Device Information
Description of the Device
The SAPPHIRE SERIES® 1100 & 1100EC Clinically Effective Low Air Loss Mattress System is
comprised of a specialized inflatable air bladder (air mattress) and an electrically powered
Control/Blower Unit.
Purpose of the Device
The purpose of the SAPPHIRE SERIES® 1100 & 1100EC Clinically Effective Low Air Loss
Mattress System is to provide therapeutic benefit to patients at risk, or suffering from pressure
ulcers.
The active component that has contact with the patient is a specialized, multi-cell air mattress
sized to fit a standard hospital bed frame. The air mattress serves as a replacement to the original
mattress and is equipped with 4 air tubes with connectors that mate with the Control Unit. The
Control Unit is a self-contained, totally enclosed module that hangs by hinged hooks on the
footboard of the bed. If the footboard is too wide, hang a control unit hanger bar on the footboard.
If no hanger bar is available, use best judgment on blower placement.
NOTE: Do not place control unit under bed.
The Control Unit is provided with a detachable hospital grade electrical cord and has a control
panel with selector switches and indicator lights. The switches and indicators are protected under
a flexible membrane to keep out liquid spills and enhance cleanup and sanitation. Inside the
Control Unit is a variable output blower and manifold that allow the air mattress to operate in a
static mode or provide alternating pressure variations within the mattress. There is also a printed
circuit board which operates the electrical controls.
Indications for Use
The SAPPHIRE SERIES® 1100 & 1100EC is a therapeutic mattress that provides either active or
reactive pressure redistribution and clinically effective low air loss therapy. When mobility,
moisture and/or inactivity are healthcare concerns, it is indicated for the prevention and treatment
of pressure ulcers and other skin related injuries.
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1100, 1100EC User Manual

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)
Alternating Low Air Loss……………………………………………………………………… 3 minutes-20 minutes
Alarms…………………………………………………………………………………..Power Failure and Low Pressure
Electrical
Rated Voltage/s…………………………………………………………………………………110 Volts and 220 Volts
Rated Frequency 110 Volts/Input Power……………………………………………………..…60Hz/120 Volts
Rated Frequency 220 Volts/Input Power……………………………………………………..…50Hz/230 Volts
Degree of Shock Protection………………………………………………………………………………………….Type B
Maximum Relative Humidity................................................................................................95%
Storage Temperature……………………………………………….……………………-18°C to 35°C (0°F to 95°F)
Environmental Conditions…Product must be stored and transported in packaging free of
moisture and dust
Power Cord…………………………………………….16’ (5 meters) detachable with hospital grade plug
Fuses 110 Volt………………………………………………………………………………...T300mA 250V…T5A 250V
Fuses 220 Volt……………………………………………………………………………………………………….T2.5A 250V
Mattresses
1100 Standard Dimensions 35”………..…..….(LxWxH) 80”(203.2cm) x 35”(88.9cm) x 8”(20.3cm)
1100 Standard Weight Capacity 35”………………………………….…………..….up to 600 lbs (272.35 kg)
1100EC Standard Dimensions ………...….(LxWxH) 80”(203.2cm) x (see note below x 8”(20.3cm)
1100EC Standard Weight Capacity ………………………………….……….………….up to 1000lbs (453 Kg)
Top Cover Material: 70 Denier Polyurethane Coated Nylon Taffeta
NOTE: The 1100EC offers several options for widths. 39”, 42”,48”, and 60”.
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1100, 1100EC User Manual

Control Unit
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
- Optional Expandable
Unpacking Instructions: Remove the products from the packing material and examine for
shipping damage. If damage is detected in shipping, contact the freight company and file a
damage complaint immediately.
Environmental Conditions:
CAUTION: Keep out of direct sunlight.
DO NOT expose to temperatures below 0°F (-18°C) or above 95°F (35°C).
DO NOT expose to moisture or areas of humidity greater than 95%.
Clinically Effective
Low Air Loss
Mattress with
Cover
Detachable 16’
Hospital Grade
Power Cord
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1100, 1100EC User Manual

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.
Directions for Mattress Placement: Replace the existing bed mattress with Clinically Effective
Low Air Loss Mattress. Secure Air Mattress to the bed frame with straps provided.
Warning or Safety Instructions relating to setup: WARNING: (120V unit ONLY)
Make sure the power cord is plugged into a properly grounded hospital grade 120V A/C
outlet.
Warning or Safety Instructions relating to setup: WARNING: (220V unit ONLY)
Make sure the power cord is plugged into a properly grounded hospital grade 220V A/C
outlet.
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1100, 1100EC User Manual

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. Remove standard mattress from the bed.
2. Replace standard mattress with the Sapphire Series® 1100, 1100EC & the Optional 39/48
Expandable Mattress Replacement System ™. (Be sure air tubing is at the foot end of the
bed).
3. Strap air support mattress to bed frame on all four sides with straps provided.
4. Place Control Unit on the footboard of the frame using the two hinged hooks located on the
back of the unit.
5. Attach the air tubing to the Control Unit, being sure it snaps in tight. (Be sure air tubing is
not kinked and is unobstructed).
6. Plug the control unit into a grounded hospital grade A/C outlet.
7. Turn the master power switch ON, located on the side of the unit.
8. Press the AUTO FIRM button for quick inflation. (see keypad quick reference section)
9. Place the patient on the bed AFTER inflation to ensure the air cells do not become twisted
or kinked.
10. After inflation, press the AUTO FIRM button again to exit Auto Firm mode. (If the Control
Unit is left in Auto Firm mode for 10 minutes then it will automatically return to the previous
mode of operation).
Modes of Operation
NOTE: See Keypad Quick Reference (table of contents) for further illustration.
Static Mode
a. Press the Mode button until the Static option light comes on.
b. Set the desired comfort level with the Soft/Firm buttons
Alternating Mode
c. Press the Mode button until the Alternate option light comes on.
d. Set the desired cycle time with Cycle Time buttons (3-20 minutes)
e. Set the desired comfort level with the Soft/Firm buttons.
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1100, 1100EC User Manual

Optional Expandable
f. By attaching the connectors within the tubing connecting to the control unit the mattress
expands from 39” (100cm) to 48” (120cm).
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1100, 1100EC User Manual

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.
Lock-out Feature
i. After 3 minutes, if there are no changes to the control unit settings, the lockout feature will
activate.
j. Press and hold the lock-out button for 3 seconds to disengage the lock-out feature.
2) For quick deflation or for CPR use:
a. Turn power off
b. Twist CPR plug on the mattress to open.
c. Remove the hoses from the control unit.
Auto Fowler
attachment
This is where the Auto Fowler attachment connects to the control unit.
Notice: The mattress is equipped with a 2-inch foam pad in the mattress base for patient support and transport.
For Inquiries Call 1-800-814-9389
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1100, 1100EC User Manual

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. Position patient on surface in center of bed.
2. Initialize soft/firm settings on control unit.
3. Wait a moment to allow internal sensors to activate pressure redistribution. Generally,
depending on patient body makeup, initial pressure redistribution is complete in
approximately 2-3 minutes.
4. Elevate the head of the bed to at least 30 degrees.
5. Unzip the mattress and visually inspect the height of the cells for sufficient inflation.
There should be several inches between the patient and the frame of the bed. Adjust the
air flow accordingly. Ask the patient if they can feel the bed frame beneath them. If yes,
add air incrementally. Repeat until patient no longer feels the frame beneath them.
6. If the patient cannot reply verbally, unzip the mattress and visually inspect the height of
the cells for sufficient air inflation. There should be several inches between the patient
and the frame of the bed. Adjust the air flow accordingly.
7. CPR: The standards for life support recommended by the American Heart Association for
performing CardioPulmonary Resuscitation (CPR) recommend a hard level surface for
performing CPR, moving the person to the floor if possible. For performing CPR, place the
CPR board, lower the head of the bed, position the patient on their back and follow standard
CPR procedures of the facility.
Positioning the Patient
When moving a patient the control unit should be in the Auto Firm Mode.
To reposition the patient, change the control unit to Auto Firm Mode. This makes the mattress
surface firm and facilitates the repositioning of the patient with less strain on the care provider.
When the patient has been repositioned, press auto firm to return to the previous setting.
NOTE: DO NOT leave a patient unattended on the mattress surface with the safety side rails in
the down position. When leaving a patient, secure the safety side rails in the up position. Make
sure the safety side rails are high enough to properly protect the patient when the mattress is fully
inflated, while continuing to be mindful of the FDA guidelines on bed rail entrapment.
Backrest Up or Fowler Position
When the patient’s backrest is elevated, it may be necessary to manually increase the mattress
firmness to compensate for the additional weight placed in the center portion of the mattress.
Observe the patient for a short time after raising the backrest to make sure the buttocks and thigh
areas are not “bottomed-out”.
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1100, 1100EC User Manual

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. Using Static Mode, lower the pressure
setting with the Firm/Soft button. Turn the patient into the side-lying position and place the bedpan.
The pressure in the center section of the mattress will lower to make inserting the bedpan easier.
The firmness setting may be adjusted to increase the firmness of the center section after the pan is
placed in position.
When the bedpan is to be removed, logroll the patient off the bedpan and remove it. Readjust the
firmness level to the appropriate setting. Select Static mode and wait for the mattress to completely
re-inflate before activating Alternate Pressure mode again.
NOTE: Always remove the bedpan before entering the Alternate mode.
Removing the Patient from the Mattress Surface
If the patient is to be removed with a transfer lift, set the control unit into Auto Firm mode. Allow
the mattress to firm and position the patient into the lift. When the patient has exited the bed, the
controller can be turned off.
If the patient can sit up and is mobile, lower the firmness level to the lowest setting and wait for the
mattress to soften in the middle. The patient can sit up and the mattress will conform to the body
making a more stable platform for patient egress. When the patient has exited the bed, the controller
can be turned off.
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1100, 1100EC User Manual

Keypad Quick Reference
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1100, 1100EC User Manual

This chart is to be used as a reference ONLY. Final patient settings must be completed by the
patient’s caregiver.
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1100, 1100EC User Manual

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. Frequent maintenance and servicing will improve performance and extend product
life.
Weekly One Month Three Months
Foam Filter X
Top Cover
X
Mattress Base
X
Mattress Connections
X
Control Unit Operation
X
Power Cord
X
The following is an equipment safety checklist that can be used with the maintenance chart to
maintain and service this product:
Inspect top cover for punctures, rips, tears or damage.
Inspect mattress base for punctures, rips, tears or damage.
Connect the control unit and verify proper operation (if installed).
Ensure air filter is clean and properly installed into control unit (if installed).
Ensure mattress is clean/disinfected and patient ready.
All power cords are fastened in a manner to keep them free from moving or pinching parts. At
any time parts are replaced, all cords should be secured into proper position to prevent damage.
Air Filter (Open cell foam filter)
The foam air filter on the back of the control unit must be
cleaned weekly with disinfectant solution (see cleaning section).
Replacement of the foam filter is recommended every 6 months.
The filter is easily removed and
reinserted through the gap in the
back housing.
HEPA Filter
X
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1100, 1100EC User Manual

−Locate and remove factory filter on the top and back of the case.
−Filter is easily removed and reinserted through the gap in the back of the case.
−Ensure HEPA filter is clean.
−Place HEPA filter on front of factory foam filter.
−Re-install filters in blower case.
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.
NOTE: Ensure factory open cell foam filter is completely dry before placing HEPA filter in
unit.
NOTE: The HEPA filter is to be installed in applicable models and pumps in conjunction
with the next factory filter cleaning procedure.
Installation
NOTE: Installation and/or handling of HEPA filter requires PPE. Service personnel
should wear a mask, gloves, and protective clothing to avoid exposure to possible
contaminants.
NOTE: Tools are not required for installation of filter.
NOTE: Ensure unit is off and/or removed from power source prior to servicing or
replacement of filter or HEPA filter.
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1100, 1100EC User Manual

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.
−Follow Installation procedure for monthly replacement of HEPA filter.
Troubleshooting
Storage
If you store your product for more than 30 days, we recommend:
−Remove HEPA filter.
−Place HEPA filter in an air-tight plastic bag or plastic wrap ensuring filter is sealed
to prevent exposure to outside contaminants.
−When you wish to operate product, reinstall HEPA filter.
Problem Cause Solution
Reduced Air flow Possible clogged filter Replace HEPA filter
Excessive noise Possible obstruction
Clogged filter
Ensure no
obstructions
Replace HEPA filter
Odor Excessive contaminants in
HEPA filter
Replace HEPA filter
HEPA Filter
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1100, 1100EC User Manual

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. Properly rinsing all cleaning agents and disinfecting chemicals is a critical step in
extending the life of covers on medical mattresses and support surfaces.
Over time, cleaning solutions may cause damage to the integrity of the fabrics used for support
surfaces. Cleaning agents that are strong enough to be efficacious cleaners and disinfectants may
cause degradation of the same fabrics on which they are being used.
To minimize the negative impact of cleaning agents:
Contact time must be monitored and kept to the required time identified on the
manufacturer’s instructions.
All cleaning solutions must be diluted in accordance with manufacturer’s instructions.
All covers must be rinsed after every cleaning cycle. Rinsing of the support surface covers
with clean water as the immediate step after the disinfection process is fundamental to
extending the usable life of the covers.
NOTE: Only the outer cover of the mattress requires cleaning and maintenance. Disassembly of
the support surface for maintenance of internal components is not recommended. DO NOT use
harsh solvents or cleaners. Special care should be used to not puncture the mattress with needles
or sharp instruments. This may result in loss of integrity of the mattress cover or internal
components.
Recommended EPA Registered Disinfectants:
Wex-Cide 128 (Wexford Labs), EPA Reg. #34810-31
Equipment must be disinfected using an EPA registered, hospital-grade disinfectant, according to
the manufacturer’s recommendations for use.
Recommended Stain Remover(s):
Stain Away (ABC Compounding)
This stain remover is effective in removing most difficult stains and is intended to be used in its
original concentration.
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1100, 1100EC User Manual