Sage Products Safety information

Oral Care for Non-Ventilator Patients

INDICATIONS FOR USE Aids in the removal of oral secretions, oral solutions, and debris from the teeth and mouth.

WARNINGS Always use a bite block if patient is not alert or cannot follow directions.

CAUTIONS Ensure foam is intact before and after use. Remove any foam particles from mouth.

Oral Care for Ventilator Patients

INDICATIONS FOR USE Aids in the removal of oral secretions, oral solutions, and debris from the teeth and mouth.

WARNINGS Always use a bite block if patient is not alert or cannot follow directions.

CAUTIONS Ensure foam is intact before and after use. Remove any foam particles from mouth.

Formulated Products

Antiplaque

INDICATIONS FOR USE Aids in the removal and prevention of plaque that leads to gingivitis

WARNINGS Stop and ask a dentist if: Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Antiseptic Oral Rinse

INDICATIONS FOR USE Helps reduce chance of infection in minor oral irritation

WARNINGS Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash, or fever develops. Irritation, pain or redness persists or worsens. Keep out of reach of children. If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Chlorhexidine Gluconate Oral Rinse

Rx only. For complete list of warnings, precautions, and adverse reactions, refer to product labeling.

INDICATIONS FOR USE Chlorhexidine Gluconate Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae. Chlorhexidine Gluconate Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG)

CONTRAINDICATIONS Chlorhexidine Gluconate Oral Rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

WARNINGS Keep out of reach of children. The effect of Chlorhexidine Gluconate. Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Chlorhexidine Gluconate Oral Rinse users compared with control users. It is not known if Chlorhexidine Gluconate Oral Rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine, see CONTRAINDICATIONS.

CoRinz

INDICATIONS FOR USE Helps reduce chance of infection in minor oral irritation

WARNINGS Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash, or fever develops. Irritation, pain or redness persists or worsens. Keep out of reach of children. If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Perox-A-Mint

INDICATIONS FOR USE Aids in the removal of secretions associated with sore mouth

WARNINGS Do not use: For more than 7 days unless told to do so by a doctor. Avoid swallowing. Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists or worsens. Keep out of reach of children. If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Comfort Bath / Shampoo Cap

INDICATIONS FOR USE Full-body washcloths / Cleanses and conditions

CAUTIONS Closely monitor heat level, especially with infants or unresponsive or skin-sensitive individuals. Gloves diminish sensitivity to heat. Do not flush.

Comfort Shield

INDICATIONS FOR USE Helps seal out wetness. Helps treat and prevent perineal dermatitis. Protects from minor skin irritation associated with perineal dermatitis

WARNINGS For external perineal use only. Avoid eye contact. Stop use and consult a doctor if condition worsens or does not improve within 7 days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on deep or puncture wound, animal bites and serious burns. Do

CAUTIONS Caution: if there is any induction barrier cloth are excessively hot, do not use. Gloves diminish sensitivity to heat. Closely monitor heat level, especially with infants or unresponsive or skin-sensitive adults.

PrimaFit

INDICATIONS FOR USE For the non-invasive external collection of urine for adolescent through adult patients with female anatomy who require urine management.

CONTRAINDICATIONS Do not use on patients with urinary retention.

WARNINGS Do not place internally

CAUTIONS Not intended for use on patients in the prone position. Not intended for use on patients with the non-retracted male anatomy. Not intended for stool collection. Use caution if using on patients with altered mental status

PrimoFit+

INDICATIONS FOR USE For the non-invasive external collection of urine for adolescent through adult patients with male anatomy who require urine management

CONTRAINDICATIONS Do not use on patients with urinary retention

CAUTIONS Not intended for use on patients in the prone position. Not intended for use on patients with female anatomy. Not intended for use for stool collection. Use caution if using on patients with altered mental status

Warmers

INDICATIONS FOR USE For warming premoistened cloth and hair care products.

WARNINGS Improper use of the grounding plug can result in a risk of electric shock. Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “hospital only” or “hospital grade.” • Install this warmer only in accordance with the installation instructions found in this manual. • Do not cover or block any openings on this appliance. • Do not tamper with or make any adjustments to the control panel, housings, safety switches, or any other part of the warmer. Repairs should only be done by a qualified service person. Contact Stryker for authorized service. • Do not remove any panel or cover. • Do not store or use this appliance outdoors. Do not use this product near water—for example, near a kitchen sink, in a wet basement, or near a swimming pool. • Do not use this warmer for any material other than premoistened cloth and hair care products manufactured by Sage Products/Comfort Personal Cleansing products, in accordance with instructions on the label. • Do not let the cord hang over edge of a table or counter. • This warmer is to be used by adults familiar with its operation and these safety instructions. • Do not operate this warmer if it has a damaged cord or plug, if it is not working properly, or if it has been damaged or dropped. • Do not immerse cord or plug in water. • Do not operate this warmer if any component is broken. Contact Stryker for repair or replacement. • Keep cord away from heated surfaces. • The warmer is to be serviced only by qualified service personnel. If there are no external or user-serviceable fuses, contact Stryker for repair or adjustment. For external or user-serviceable fuses, check them and replace if necessary. If new fuses do not correct the condition, or if fuses continue to blow, contact Stryker for repair or adjustment. • Use this appliance only for its intended purpose as described in this manual. Do not use corrosive chemicals or vapors in this appliance. This type of warmer is specifically designed to warm premoistened cloth and hair care products manufactured by Sage Products LLC/Comfort Personal Cleansing products. It is not designed for industrial or laboratory use. The use of corrosive chemicals in heating or cleaning will damage the appliance and may result in product failure. • Warm only premoistened cloth and hair care products manufactured by Sage Products LLC/Comfort Personal Cleansing products. • Do not use to heat or store any other material or products. • If materials inside the warmer should ignite, keep the door(s) closed, turn the warmer off, and disconnect the power cord, or shut off power at the fuse or circuit breaker panel. • Do not store flammable materials in the proximity of the warmer. It could be a fire hazard. • Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, or with oxygen or nitrous oxide. • This warmer uses conduction heating. • The warmer should not be adjusted outside of menu driven options by anyone except properly qualified personnel. Contact Stryker for authorized service. • Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to these instructions. The end user of this product should assure it is used in such an environment that the power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

CAUTIONS This warmer is to be used solely with premoistened cloth and hair care products manufactured by Sage Products LLC/Comfort Personal Cleansing products. The warmer has been designed and safety tested to be used exclusively with these products only. Any other use of this warmer by the facility including, but not limited to, use with other brands of products, can result in overheating, fire or other hazardous conditions. • Do not tamper with or make any adjustments to the control panel, housings, safety switches, or any other part of the warmer. Repairs should only be done by a qualified service person. Contact Stryker for authorized service. • Do not use warmer if door/window is shattered/cracked, broken or has sharp edges. Repairs should only be done by a qualified service person. Contact Stryker for authorized service. • If a fire occurs in the warmer, leave door(s) closed. Disconnect the power cord, or shut off power at the fuse or circuit breaker panel. • Do not store flammable materials next to, on top of, in or near the warmer. • Your warmer is equipped with a protective device designed to turn the unit off in the event of overheating. The warmer will remain inoperable until it has cooled • No preventative maintenance is recommended except routine cleaning as described in this manual. • If there is any indication that the premoistened cloth and/or hair care products are excessively hot, do not use. • Remember, gloves diminish your sensitivity to heat. Closely monitor heat level with infants, unresponsive or skin sensitive individuals. • Products are for individual use only.

AirTAP

INDICATIONS FOR USE To assist and maintain proper patient positioning to offload the sacrum and control body heat and moisture. To assist with the repositioning of a patient.

CONTRAINDICATIONS Patients who have thoracic, cervical, or lumbar fractures should not use the Prevalon AirTAP System (the “System”) unless a clinical decision has been made by your facility. The equipment should not be used for patients that exceed the 550 lb / 250 kg weight limit.

WARNINGS Failure to comply with this Manual could result in injury or equipment malfunction. Alterations or modifications to the System can affect the safety and functionality of the System and are strictly prohibited. To reduce the risk of fire or injury: • Always follow your facility’s safe patient handling policies and procedures.• Never leave the patient unattended while the Air Pump / Booster Pump is powered on or the Glide Sheet is inflated. • Always use at least two caregivers when Positioning and Boosting. • Always use at least two caregivers while performing the Lateral Transfer. • Exterior bed rails on both surfaces should be raised prior to transfer to prevent the patient from falling. If there are no bed rails used, the caregivers are responsible for making sure the patient does not reach outside the boundaries of either support surface. • DO NOT use the Glide Sheet to lift patients. • To avoid potential skin injury, ensure the patient’s head and feet are supported to prevent them from dragging across the bed. • To prevent injury or accidental inflation, ensure patient is not in contact with the Quick Connect Valve or Quick Connect Hose. • Ensure the support surface is wide enough to roll the patient from a supine to a prone position. • Always use at least seven (7) caregivers when placing the patient in the prone position. • Do not inflate the Glide Sheet during prone positioning. • To avoid potential injury, ensure the patient’s head and feet are supported during prone positioning. • DO NOT use the Air Pump / Booster Pump in the presence of flammable anesthetics or other flammable gases or vapors. • Ensure lines and tubing are free to move with the patient and that nothing obstructs the turn. Follow your hospital’s Prone Positioning protocol for correctly handling lines and tubing. • Follow your hospital protocol if the patient is ventilated. If the patient is connected to a ventilator, the patient should be rolled toward the ventilator. • Follow your facility inclusion criteria for patient prone positioning. • To avoid injury, route the Air Pump / Booster Pump power cord out of the patient’s reach and away from bed wheels so that it will not be pinched or damaged and does not cause a tripping hazard. • Before inflating, ensure lines and tubing are free to move with the patient and that nothing obstructs the area over which the Glide Sheet will pass. Ensure that the Hose will move freely with the Glide Sheet. • Ensure the Glide Sheet is fully inflated prior to transfer. If the Glide Sheet is not fully inflated, injury to the patient or caregiver could occur or the Glide Sheet may not perform as expected. • DO NOT store or use the Air Pump / Booster Pump outdoors. • DO NOT use the Air Pump / Booster Pump near water. • DO NOT cover or block any openings on the Air Pump / Booster Pump. • DO NOT tamper with or make any adjustments to any part of the Air Pump / Booster Pump. • DO NOT let the Air Pump / Booster Pump cord hang over the edge of a table or counter. • DO NOT operate the Air Pump / Booster Pump if it has a damaged cord or plug, if it is not working properly, or if it has been damaged or dropped. Contact Sage Products at 800.323.2220 for repair or replacement. • DO NOT immerse the Air Pump / Booster Pump cord or plug in water. • Keep cord away from heated surfaces. • The Air Pump / Booster Pump has been designed for use exclusively with the Sage air assisted technology products. • DO NOT use the Air Pump / Booster Pump during transport. • The Glide Sheet is not intended to secure a patient to a support surface. Follow facility policies and procedures for securing patients to a support surface.

CAUTIONS • Periodically check product for signs of wear. Replace if product is damaged.• DO NOT launder any component of the System. • DO NOT plug the Air Pump / Booster Pump into the outlet on the bed. • Glide Sheet for single patient use only.

AirTAP LC

INDICATIONS FOR USE Indicated for use for lifting and transferring adult patients that are unable to bear weight or have limited mobility. The device can be used for adult patients who are dependent or partially-dependent and unable to participate in their own turning, positioning, or lateral transfer.

CONTRAINDICATIONS The AirTAP LC System should not be used for patients with thoracic, cervical, or lumbar fractures without a clinical assessment of the risks of using the device. This device should not be used on patients with an altered mental status. The equipment should not be used for patients that exceed the 600 lb / 272 kg weight limit.

WARNINGS • Do not use on patients with thoracic, cervical, or lumbar fractures that are deemed unstable unless stabilization is used or a clinical assessment of the risks has been performed. • Do not use Air Pump / Booster Pump while connected to a lift.• Never leave a patient unattended while the Glide Sheet is inflated or the Air Pump / Booster Pump is powered on. • To reduce the risk of electric shock, do not use outdoors or on wet surfaces. • Always ensure the patient is centered on the Glide Sheet before inflating. • Always ensure the bed rails are raised and the bed brakes are locked. • Always use more than one trained healthcare provider to laterally transfer, vertical lift transfer, or reposition a patient to avoid the risk of healthcare provider injury. Note: Exterior bed rails on both surfaces should be raised prior to transfer to prevent the patient from falling. If there are no bed rails used, the caregivers are responsible for making sure the patient does not reach outside the boundaries of either support surface. • Ensure the Glide Sheet is fully inflated prior to transfer. If the Glide Sheet is not fully inflated, injury to the patient or caregiver could occur or the Glide Sheet may not perform as expected. • Always follow your facility’s safe patient handling and mobility policies and procedures.• To avoid potential skin injury, prevent patient’s heels and head from dragging across the bed during repositioning. Refer to your facility’s skin injury and prevention protocol and the National Pressure Injury Advisory Panel (NPIAP) Guidelines.• To prevent injury or accidental inflation, ensure the patient is not in contact with the Quick Connect Hose Nozzle or Flexible Inflation Hose.• Do not use the product in an oxygen-rich environment, such as an oxygen tent. • Do not use the Air Pump / Booster Pump in the presence of flammable anesthetics or other flammable gases or vapors. • Do not tamper with or make any adjustments to any part of the Air Pump / Booster Pump.• Do not let the Air Pump / Booster Pump cord hang over the edge of a table or counter. • Do not operate the Air Pump / Booster Pump if it has a damaged cord or plug, if it is not working properly, or if it has been damaged or dropped. Contact Stryker at 800 323 2220 for repair or replacement. • Do not immerse the Air Pump / Booster Pump cord or plug in water. • Keep Air Pump / Booster Pump cord away from heated surfaces. • Do not use the Air Pump / Booster Pump during patient transport within the care setting. • The Glide Sheet is not intended to secure a patient to a support surface. Follow facility policies and procedures for securing patients to a support surface (e.g. Trendelenburg). • Always ensure straps are untucked before transferring or turning a patient. • Always ensure the Sling Straps are not twisted and are properly attached to the lift(s). • Do not use the Glide Sheet with a hanger bar that is designed for a clip attachment. • Do not hold or support a patient’s weight while the Glide Sheet is attached to a lift since this may cause straps to detach from lift. • Never leave a patient unattended while the Glide Sheet is attached to a lift. • Before inflating, ensure lines and tubing are free to move with the patient and that nothing obstructs the area over which the Glide Sheet will pass. Ensure that the Hose will move freely with the Glide Sheet. • Ensure walkways are clear of straps to avoid tripping hazard. • Ensure straps are out of the patient’s reach to avoid entanglement and pressure related injury. • Do not lift in prone position.

CAUTIONS • Improper usage of the product can cause injury to the patient or healthcare provider. • Do not modify the product or any components of the product. Modifying the product can cause unpredictable operation resulting in injury to the patient or healthcare provider. • Do not allow any part of the lift to contact the patient. • Always position the patient’s arms inside the Sling Straps. • Always properly handle the Air Pump / Booster Pump power cord to avoid the risk of entanglement, tripping, damage to the power cord, or potential shock hazards. If the power cord is damaged, immediately remove the product from service and contact the appropriate maintenance personnel. • Always plug the Air Pump / Booster Pump directly into a properly grounded hospital-grade or medical-grade wall outlet to achieve grounding reliability. Do not plug the product directly into a hospital bed. • Electric shock risk. The Air Pump / Booster Pump must only be connected to a supply main with protective earth. • Always store the Air Pump / Booster Pump power cord before you transport the product to avoid a trip hazard. • Do not overload the Glide Sheet above the safe working load of 600 lbs (272 kg). Ensure patient fits entirely within the edges of the Glide Sheet. • The AirTAP LC Glide Sheet and M2 Microclimate Body Pad are made from non-metal materials and have been determined to be MR safe; however, the Air Pump / Booster Pump are made from metal materials and are not MR safe. Follow your facility’s protocol for use of the product in an MR environment. • Do not cover or block any openings on the Air Pump / Booster Pump. • The Air Pump / Booster Pump is not to be used with other manufacturers’ air-assisted products. • The Glide Sheet is not to be used with other manufacturers’ air pump units. • Do not hang the Air Pump / Booster Pump from the bed rails to avoid Air Pump / Booster Pump instability. • Do not launder the product or any components of the product. Laundering the product can cause unpredictable operation resulting in injury to the patient or healthcare provider. • Periodically check product for signs of wear. Replace if product is damaged. • Glide Sheet for single patient multiple use.

Lateral Transfer

HalfMATs

INDICATIONS FOR USE The system is intended to reduce the friction between the patient and the supporting surface to allow the operator to move the patient with less effort. The System is intended to be used in hospitals, healthcare facilities, and other environments where the horizontal lateral transfer of patients is required, and where repositioning of patients is desired. The system is to be used on patients weighing up to 500 lbs / 227 kg. The HalfMATS Mat is intended for single patient use. The Microclimate Management Pad is intended for single use.

CONTRAINDICATIONS Patients who have thoracic, cervical, or lumbar fractures that are deemed unstable should not use HalfMATS unless a clinical decision has been made by your facility. HalfMATS should not be used for patients that either exceed the 500 lbs / 227 kg weight capacity or for patients whose shape does not comfortably fit within the edges of the pad.

WARNINGS To reduce the risk of fire or injury: 1. Do not launder the Mat or the Microclimate Management Pad. 2. Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “hospital only” or “hospital grade.” 3. Do not cover or block any openings on the Air Pump / Blower Cart. 4. Do not tamper with or make any adjustments to the control panel, housings, safety switches, or any other parts of the Air Pump / Blower. 5. Do not remove any panel or cover. 6. Do not store or use the Air Pump / Blower outdoors or near water. 7. The Air Pump / Blower has been designed for use exclusively with Sage air assisted technology products. 8. Do not operate the Air Pump / Blower if it has a damaged cord or plug, if it is not working properly, or if it has been damaged or dropped. Contact Stryker at 800 323 2220 for repair or replacement. 9. Always store the Air Pump / Blower power cord before you transport the product to avoid a trip hazard. 10. Do not immerse the Air Pump / Blower cord or plug in water. 11. Keep cord away from heated surfaces. 12. Do not use in the presence of flammable anesthetics and other flammable solvents and materials. 13. Do not hang Air Pump / Blower from the bed rails. 14. To reduce the risk of fire, electrical shock, or injury, unplug Air Pump / Blower from electrical outlet before servicing. 15. If overtightened, the filter will not properly function. 16. If your hospital protocol directs that the Mat is to be tucked underneath a surgical table pad, ensure the Mat does not inhibit the function of the surgical table pad. 17. When transferring or repositioning a patient on a Support Surface without rails, ensure the Mat and patient are centered on the Support Surface. 18. Do not use to lift patients. 19. The Mat is not intended to secure a patient to a Support Surface. 20. Follow facility policies and procedures for securing patients to a Support Surface. Do not use for Trendelenburg positioning. 21. Patient repositioning should always be performed using at least three caregivers. 22. Do not inflate the Mat during surgery. 23. Never leave a patient unattended while the Mat is inflated or the Air Pump / Blower is powered on. 24. The Mat is not to be used with other manufacturer’s Air Pump / Blower units. 25. Always ensure patient is centered left to right on the Mat before inflating. 26. Ensure the Mat / Microclimate Management pad is not pinched between Support Surfaces before inflation. 27. To prevent the patient from falling, before every transfer,make sure that the patient is positioned correctly on the Mat and the Mat is centered on the Support Surface. 28. Do not place the Mat beneath a patient who is already on the OR table. 29. Always use at least three caregivers to perform a lateral transfer. Exterior bed rails on both surfaces should be raised prior to transfer to prevent the patient from falling. If there are no bed rails used, the caregivers are responsible for making sure the patient does not reach outside the boundaries of either Support Surface. 30. Ensure the patient is centered on the Receiving Surface prior to deflating the Mat. 31. To avoid caregiver or patient injury, make sure the bed rails are raised and the bed brakes are locked. 32. To prevent injury or accidental inflation, ensure patient is not in contact with the Quick Connect valve or Flexible inflation hose at all times. 33. If the Mat is not fully inflated, injury to the patient or caregiver could occur, or the Mat may not perform as expected. 34. Always ensure buttocks are placed above the Break line. 35. Before inflating, ensure lines and tubing are free to move with the patient and that nothing obstructs the area over which the Mat or linen will pass. Ensure that the hose will move freely with the Mat.

CAUTIONS • Touching patient during transfer could result in minor static electric shock. • Improper use of the product can cause injury to the patient or healthcare provider. Operate the product only as described in this manual. • Do not overload the Mat above the safe working load of 500 lbs. Ensure patient fits entirely within the edge of the Mat. • Periodically check System for signs of wear, debris, or damage. If damaged, do not use.

MP-MATS

INDICATION FOR USE The System is intended to provide physical and frictional securement for a patient in Trendelenburg, Reverse Trendelenburg, Lithotomy, and the Lateral Tilt positions to help prevent sliding. It is also intended to reduce the friction between the patientand the supporting surface by helping the operator move the patient with less effort. The System is intended to be used in hospitals and healthcare facility environments where the horizontal lateral transfer of patients is required and where the positioning of patients in Trendelenburg, Reverse Trendelenburg, Lithotomy, and Lateral Tilt positions is required. The System may be used on patients weighing up to 400 lbs / 181 kg and whose torso fits within the confines of the per forated foam pad from top of the shoulder to the bottom of the buttocks. The chest strap, perforated foam pad, and M2 Microclimate Body Pad are intended for single use only. The Mat is intended for single patient - multiple use

CAUTIONS Do not modify the product or any components of the product. Modifying the product can cause unpredictable operation resulting in injury to the patient or healthcare provider. Periodically check System for signs of wear, debris, or damage. If damaged, do not use. Improper use of the product can cause injury to the patient or healthcare provider. Operate the product only as described. Touching patient during transfer could result in minor static electric shock. Improper use of the product can cause injury to the patient or healthcare provider. 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 the patient or healthcare provider. The Mat, when used without the foam pad, is not intended to secure a patient to a support surface. Periodically check System for signs of wear, debris, or damage. If damaged, do not use. Be sure to follow your facility’s policies and guidelines for frequency of patient monitoring. Check skin for integrity and proper circulation. Do not use on patients with compromised skin which will be in contact with the foam pad. Product is to be used by healthcare professionals only. Before using the System, ensure that the OR table pad is securely affixed to the OR table and is clean and free of residue.

CONTRAINDICATIONS Patients who have thoracic, cervical, or lumbar fractures that are deemed unstable should not use the Mat / System unless a clinical decision has been made by your facility. Patients who have high intraocular pressure should not use the Mat / System unless a clinical decision has been made by your facility. The System should not be used for patients who exceed the 400 lbs / 181 kg weight capacity. The Mat / System should not be used for patients whose torso does not fit within the confines of the perforated foam pad from top of the shoulder to the bottom of the buttocks. Do not use on patients with compromised skin which will be in contact with foam.

WARNINGS – SYSTEM • Ensure the surface is horizontal prior to placing the patient on the System. • Do not use the System in conjunction with sheets or covers on an OR table. The System must be in direct contact with the OR table. • Always ensure buttocks are placed above the break line. • To avoid caregiver or patient injury, make sure the bed brakes are locked. • Always ensure the patient is centered on the Mat / System and the Mat / System is centered on the support surface. • Do not place the System beneath a patient who is already on the OR table. • If your hospital protocol directs that the System is to be tucked underneath an OR table pad, ensure the System does not inhibit the function of the OR table pad. • Do not overload the System above the safe working load of 400 lbs / 181 kg. Ensure that the patient’s torso fits within the confines of the perforated foam pad from top of the shoulder to the bottom of the buttocks. • Do not tighten the chest strap such that it impedes patient breathing. Ensure chest strap is only used on intact skin. • Do not inflate the System during surgery. • Ensure the arm wraps and chest strap are used. • If patient sliding is observed during a surgical procedure, follow your facility’s protocol for patient securement. • Do not use bed pillows between patient and Mat. • Follow your facility’s protocol for use of a lap belt. • Always use at least three caregivers to perform a lateral transfer or repositioning. Exterior bed rails and brakes on both surfaces should be raised and locked prior to transfer or repositioning to prevent the patient from falling. If there are no bed rails, the caregivers are responsible for making sure the patient does not reach outside the boundaries of either support surface. • Ensure the Mat / System / the white underpad is not pinched between support surfaces before inflation. • Ensure the rail straps are not secured to the support surface during a lateral transfer. • Ensure the chest strap is not secured to the support surface during a lateral transfer. • To prevent injury or accidental inflation, ensure patient is not in contact with the quick connect valve or flexible inflation hose at all times. • Do not use in the presence of flammable anesthetics and other flammable solvents and materials. • The Mat / System is not to be used with other manufacturer’s air pump units. • Before inflating, ensure lines and tubing are free to move with the patient and that nothing obstructs the area over which the Mat / System or linen will pass. Ensure that the hose will move freely with the Mat / System. • Never leave a patient unattended while the Mat / System is inflated, or the Air Pump is powered on. • If the Mat / System is not fully inflated, injury to the patient or caregiver could occur, or the Mat / System may not perform as expected. • Do not launder the product or any components of the product. Laundering the product can cause unpredictable operation resulting in injury to the patient or healthcare provider. • Do not use to lift patients.

WARNINGS – AIR PUMP Electric shock risk. The Air Pump must only be connected to a supply with protective earth. • Do not cover or block any openings on the Air Pump. • Do not tamper with or make any adjustments to the control panel, housings, safety switches, or any other parts of the Air Pump. • Do not store or use the Air Pump outdoors or near water. • Always properly handle the Air Pump power cord to avoid the risk of entanglement, tripping, damage to the power cord, or potential shock hazards. If the power cord is damaged, immediately remove the product from service and contact the appropriate maintenance personnel. • Do not immerse the Air Pump cord or plug in water. • Keep cord away from heated surfaces. • Do not hang Air Pump from the bed rails. • To reduce the risk of fire, electrical shock, or injury, unplug Air Pump from electrical outlet before servicing. • If overtightened, the filter will not properly function. • Do not operate the Air Pump if it has a damaged cord or plug, if it is not working properly, or if it has been damaged or dropped. Contact Stryker at 800 323 2220 for repair or replacement.

Heel Protection

INDICATIONS FOR USE To offload heel

CAUTIONS For use on patient while in bed. DO NOT stand or walk while wearing due to fall risk. Periodically remove heel protector to assess skin according to protocol. For single patient use.

Seated Positioning

INDICATIONS FOR USE Assists and maintains proper patient positioning and redistributes pressure associated with sitting in a bedside chair.

CAUTIONS • DO NOT use to lift patients • Only use with standard hospital chair, or rolling chair with brakes. • Not recommended for use with a wheelchair.• Patient positioning should always be performed following your facility’s safe patient handling policies and procedures. • Periodically check product for signs of wear. Replace if product is damaged. • DO NOT launder. Wipe clean with a damp cloth. • Single patient - multiple use, Patient unique - usage multiple. • Weight limit: 350 lbs/160 kg

2% Chlorhexidine Gluconate Cloths

INDICATIONS FOR USE Helps reduce bacteria that can potentially cause skin infection. For preparation of skin prior to surgery.

WARNINGS For external use only. Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing / difficulty breathing, shock, facial swelling, hives, rash. If an allergic reaction occurs, stop use and seek medical help right away. Do not use. On patients allergic to chlorhexidine gluconate or any other ingredient in this product. For lumbar punctures or in contact with the meninges. On open skin wounds or as a general skin cleanser. When using this product. Keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reactions occurs. These may be signs of a serious condition. Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away. Do not flush

Nose to Toes

INDICATIONS FOR USE Skin antisepsis, oral cleansing, and nasal antisepsis system

WARNINGS Reference Warnings as listed under Oral Hygiene and Pre-Op Prep: CHG Cloths