Medical Device CE marking - CEpartner4U
TapMed Swiss AG - TapMed Swiss AG
User Manual for HOVERTECH models including: PROS-WT Patient Repositioning Off Loading System, PROS-WT, Patient Repositioning Off Loading System, Repositioning Off Loading System, Loading System, System
English HoverMatt PROSWedge Manual - HoverTech International
8 mar 2024 — HoverMatt PROSWedge is a component of the HoverMatt PROS™ (Patient. Repositioning Off-Loading System) to assist caregivers with patient positioning.8 pagine
File Info : application/pdf, 8 Pages, 1.32MB
DocumentDocumentPatient Repositioning Off-Loading System User Manual Visit www.HoverMatt.com for other languages TABLE OF CONTENTS Symbol Reference ..........................................................2 Intended Use and Precautions........................................3 Part Identification - HoverMatt PROSWedge ..................4 HoverMatt PROSWedge Product Specifications .............4 Instructions for Use .....................................................5-6 Cleaning and Preventive Maintenance ...........................6 Returns and Repairs........................................................7 Symbol Reference PROSWedgeTM User Manual CE MARKING OF CONFORMITY UK MARKING OF CONFORMITY AUTHORIZED REPRESENTATIVE UK RESPONSIBLE PERSON SWITZERLAND AUTHORIZED REPRESENTATIVE CAUTION / WARNING DISPOSAL FOOT END OPERATING INSTRUCTIONS LATEX FREE LOT NUMBER MANUFACTURER DATE OF MANUFACTURE MEDICAL DEVICE SERIAL NUMBER SINGLE PATIENT - MULTIPLE USE DO NOT LAUNDER UNIQUE DEVICE IDENTIFIER 2 | HoverTech HMPROSWedgeManual, Rev. B PROSWedgeTM User Manual Intended Use and Precautions INTENDED USE HoverMatt PROSWedge is a component of the HoverMatt® PROSTM (Patient Repositioning Off-Loading System) to assist caregivers with patient positioning. Patient turning and wedge placement relieves pressure on bony prominences aiding Q2 compliance. The wedge delivers a 30 degree turning angle for patients at risk for pressure injuries. The HoldFastTM foam keeps the wedge properly placed under the patient and in place with the bed to reduce patient sliding. HoverMatt PROSWedge may also be used with any HoverMatt® Single Patient Use Mattress or HoverSling® Repositioning Sheet. I N D I C AT I O N S · Patients that need Q2 turning for pressure off-loading of bony prominences. · Patients with compromised skin breakdown. C O N T R A I N D I C AT I O N S · Do not use with patients whose medical condition contraindicates turning. INTENDED CARE SETTINGS · Hospitals, long-term or extended care facilities. PRECAUTIONS HOVERMATT PROSWEDGE · For in-bed positioning tasks, more than one caregiver may need to be used. · Use this product only for its intended purpose as described in this manual. Side rails must be raised with one caregiver. Do not place HoverMatt PROSWedge into a pillowcase in order to maintain the non-slip benefit of HoldFastTM. HMPROSWedgeManual, Rev. B www.HoverMatt.com | 3 PROSWedgeTM User Manual Part Identification HoverMatt PROSWedge Artwork shows proper wedge orientation. Immersive foam comfortably conforms to the patient while maintaining a turned position. 30 degree angle supports proper offloading. Wipeable, nylon material - compatible with hospital disinfectants. HoldFast® Foam located on top 30° and bottom for slip resistance. Product Specifications HOVERMATT PROSWEDGE Material: 70D Calendared Polyester HoldFastTM high friction foam Construction: Sewn Width: Length: 16" (40.6 cm) 29.75" (75.6 cm) with tail. 11.75" (29.8 cm) without tail. Model #: PROS-W (Pair of Wedges W/O Tail, Compressed) 5 pairs per box Model #: PROS-WT (Pair of Wedges W/ & W/O Tail, Compressed) 5 pairs per box Artwork shows proper wedge orientation. Tail keeps wedge secured under patient and reduces patient migration. 4 | HoverTech HMPROSWedgeManual, Rev. B PROSWedgeTM User Manual Instructions for Use with HoverMatt® PROSTM, HoverMatt®, or HoverSling® WEDGE INSERTION TO TURN PATIENT AIR-ASSISTED (SINGLE CAREGIVER) 1. Center patient on the HoverMatt or HoverSling, with strap(s) unconnected. Raise the side rails on the opposite side of the bed the patient will be turned toward. The bed should be in a flat position. 2. Place the air supply nearby for convenience. Insert the hose into the foot-end of the mattress and initiate air flow by selecting the appropriate button for the size of the product being used. 3. Once fully inflated, slide the patient in the opposite direction of the turn. Slide them as close to the edge of the bed as possible to ensure that when the patient is repositioned they will be centered on the bed. 4. Place the HoverMatt PROSWedge with the up arrows pointing in the proper direction between the HoverMatt or HoverSling and the bed surface. Identify the location of the sacrum and use clinical judgement to position the wedge(s). Ensure the back part of the wedge is elevated until the position is set, then lower the wedge down to secure in place with the HoldFastTM foam. Place one wedge below the sacrum and the other wedge one hand's width above the lower wedge. 5. If using a tail wedge, insert the tail under the patient's thighs placing the wedge below the sacrum. Pull the tail through to the other side of the patient to secure the wedge in place. Place the other non-tail wedge one hand's width above the lower wedge to support the patient's upper body. 6. Once the patient is repositioned, press the STANDBY button to stop air flow. Check wedge placement by placing your hand between the wedges, confirming the sacrum is not touching the bed. Raise the head of the bed as desired and recheck the sacrum. Raise the siderails or follow your facility's protocol. NOTE: Raise both siderails prior to transitioning to the opposite side of the bed while the mattress is inflated. Siderails may be lowered again when performing additional tasks. WEDGE PL ACEMENT WITH AIR-ASSISTED MATTRESSES PUSH DOWN METHOD (2 CAREGIVERS) 1. Center patient on the HoverMatt or HoverSling, with strap(s) unconnected. The bed should be in a flat position. 2. Place the air supply next to the caregiver on the opposite side of the turn direction. Insert the hose into the foot-end of the mattress and initiate air flow by selecting the appropriate button for the size of the product being used. 3. Once fully inflated, slide the patient in the opposite direction of the turn, slide them as close to the edge of the bed as possible to ensure that when the patient is repositioned they will be centered on the bed. 4. To turn the patient on their side, the caregiver on the side patient will turn towards will gently push down on the HoverMatt or HoverSling at the patient's shoulder and hip, while the turning caregiver gently pulls up on the handles. Once the patient is turned on their side, the caregiver the patient is turned towards will stay with the patient while the turning caregiver presses the STANDBY button to stop air flow. The caregiver supporting the patient may hold the handles of the HoverMatt or HoverSling while the other caregiver places the wedges. 5. Place the HoverMatt PROSWedge between the HoverMatt or HoverSling and the bed surface with the patient side facing up. Clinical judgment should be used when positioning wedges. Ensure the back part of the wedge is elevated until the position is set, then lower the wedge down to secure in place with the HoldFastTM foam. Locate the sacrum and place one wedge below the sacrum. Position the other wedge, one hand's width above the lower wedge to support the patient's upper body. If using the tail wedge, slide the tail under the patient's thighs to secure the wedge below the sacrum. 6. Lower the patient onto the wedges, ensure straps are not underneath the HoverMatt or HoverSling. If utilizing the tail wedge, pull the tail through to the patient's other side until taut. Check wedge placement by placing your hand between the wedges, confirming the sacrum is not touching the bed. Raise the head of the bed as desired and recheck the sacrum. Raise the siderails or follow your facility's protocol. WEDGE PL ACEMENT WITH A CEILING OR PORTABLE LIFT (SINGLE CAREGIVER) 1. For use with any HoverMatt or HoverSling products, a ceiling or portable lift can be utilized for patient turns to place the HoverMatt PROSWedge. 2. Raise the siderails on the opposite side of the bed the patient will be turned toward. Ensure the patient is centered and slide the patient in the opposite direction of the turn using either a supine lift (see the HoverSling User Manual) technique or air-assisted technique as detailed above. This will allow the patient to be centered on the bed when repositioned on the wedges. 3. Attach the shoulder and hip loop straps (HoverSling) or the shoulder and hip handles (HoverMatt) to the hanger bar which should be parallel to the bed. Raise the lift to initiate the turn. 4. Place the HoverMatt PROSWedge between the HoverMatt (or HoverSling) and the bed surface with the patient side facing up. Clinical judgment should be used when positioning wedges. Ensure the back part of the wedge is elevated until the position is set, then lower the wedge down to secure in place with the HoldFastTM foam. Locate the sacrum and place one wedge below the sacrum. Position the other wedge, one hand's width above the lower wedge, to support the patient's upper body. If using the tail wedge, slide the tail under the patient's thighs to secure the wedge below the sacrum. 5. Lower the patient onto the wedges, ensure straps are not underneath the HoverMatt or HoverSling. If utilizing the tail wedge, pull the tail through to the patient's other side until taut. Check wedge placement by placing your hand between the wedges, confirming the sacrum is not touching the bed. Raise the head of the bed as desired and recheck the sacrum. HMPROSWedgeManual, Rev. B www.HoverMatt.com | 5 PROSWedgeTM User Manual WEDGES PLACEMENT NON-AIR (2 CAREGIVERS) 1. For use with the non-air HoverMatt® PROSTM or HoverMatt® PROSTM Sling, ensure patient is centered and slide the patient in the opposite direction of the turn to ensure there is room for the turn with the patient centered in the bed when repositioned. Using good ergonomic stature, manually turn the patient using the turning handles or the sling straps. 2. Place the HoverMatt PROSWedge between the HoverMatt PROS or HoverMatt PROS Sling and the bed surface with the patient side facing up. Clinical judgment should be used when positioning wedges. Ensure the back part of the wedge is elevated until the position is set, then lower the wedge down to secure in place with the HoldFastTM foam. Locate the sacrum and place one wedge below the sacrum. Position the other wedge, one hand's width above the lower wedge, to support the upper body of the patient. If using the tail wedge, slide the tail under the patient's thighs to secure the wedge in place. 3. Lower the patient onto the wedges, ensure straps are not underneath the HoverMatt PROS or HoverMatt PROS Sling. If utilizing the tail wedge, pull the tail through to the patient's other side until taut. Check wedge placement by placing your hand between the wedges, confirming the sacrum is not touching the bed. Raise the head of the bed as desired and recheck the sacrum. Raise the siderails or follow your facility's protocol. Cleaning and Preventive Maintenance HOVERMATT PROSWEDGE CLEANING INSTRUCTIONS Disposable. When soiled, the HoverMatt PROSWedge should be wiped down with disinfecting wipes or a cleaning solution used by your hospital for medical equipment disinfection. Allow to air dry before using. Do not launder or place it in a dryer. PREVENTIVE MAINTENANCE Prior to use, a visual inspection should be performed on the HoverMatt PROSWedge to ensure that there is no visible damage that would render the it unusable. If any damage is found that would cause the system not to function as intended, the HoverMatt PROSWedge should be removed from use and discarded. INFECTION CONTROL The single-patient use HoverMatt PROSWedge eliminates the possibility of cross-contamination and the need for laundering. When a product reaches the end of its lifetime, it should be separated by material type so that the parts can be recycled or disposed of properly in accordance with local requirements. Transportation and Storage This product does not require any special storage conditions. 6 | HoverTech HMPROSWedgeManual, Rev. B PROSWedgeTM User Manual Returns and Repairs All products being returned to HoverTech must have a Returned Goods Authorization (RGA) number issued by the company. Please call (800) 471-2776 and ask for a member of the RGA Team who will issue you an RGA number. Any product returned without an RGA number will cause a delay in the repair time. Returned products should be sent to: HoverTech Attn: RGA # ___________ 4482 Innovation Way Allentown, PA 18109 For European companies, send returned products to: Attn: RGA #____________ Kista Science Tower SE-164 51 Kista, Sweden For product warranties, visit our website: https://hovermatt.com/standard-product-warranty/ HoverTech 4482 Innovation Way Allentown, PA 18109 www.HoverMatt.com Info@HoverMatt.com These products comply with the standards applicable for Class 1 products in the Medical Device Regulation (EU) 2017/745 on medical devices. CEpartner4U, ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS. www.cepartner4u.com Etac Ltd. Unit 60, Hartlebury Trading Estate, Hartlebury, Kidderminster, Worcestershire, DY10 4JB +44 121 561 2222 www.etac.com/uk TapMed Swiss AG Gumprechtstrasse 33 CH-6376 Emmetten CHRN-AR-20003070 www.tapmed-swiss.ch In case an adverse event in relation to the device, incidents should be reported to our authorized representative. Our authorized representative will forward information to the manufacturer. HMPROSWedgeManual, Rev. B www.HoverMatt.com | 7 4482 Innovation Way Allentown, PA 18109 800.471.2776 Fax 610.694.9601 www.HoverMatt.com Info@HoverMatt.com