HoverTech International | Elevate Your Standard Of Care
Medical Device CE marking - CEpartner4U
HoverTech International | Elevate Your Standard Of Care
TapMed Swiss AG - TapMed Swiss AG
Standard Product Warranty - HoverTech International
User Manual for HOVERTECH models including: T-Burg Trendelenburg Patient Stabilization and Air Transfer Mattress, T-Burg, Trendelenburg Patient Stabilization and Air Transfer Mattress, Patient Stabilization and Air Transfer Mattress, Stabilization and Air Transfer Mattress, Air Transfer Mattress, Transfer Transfer Mattress, Transfer Mattress, Mattress
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DocumentDocumentTrendelenburg Patient Stabilization & Air-Transfer Mattress User Manual Visit www.HoverTechInternational.com for other languages TABLE OF CONTENTS Symbol Reference ..........................................................2 Intended Use and Precautions........................................3 Part Identification - HoverMatt® T-BurgTM.........................4 Product Specifications/Required Accessories..................4 Transfer from PACU to (O.R.) Table.................................5 Attaching to Operating Room (OR) Table ...................5-9 Part Identification - HT-Air® Air Supply..........................10 HT-Air® Keypad Functions ............................................10 Air200G/Air400G Air Supplies......................................10 Cleaning and Preventive Maintenance .........................11 Returns and Repairs......................................................12 Symbol Reference T-BurgTM User Manual CE MARKING OF CONFORMITY UK MARKING OF CONFORMITY AUTHORIZED REPRESENTATIVE UK RESPONSIBLE PERSON SWITZERLAND AUTHORIZED REPRESENTATIVE CAUTION / WARNING IMPORTER DISPOSAL OPERATING INSTRUCTIONS CENTER PATIENT FASTEN PATIENT SAFETY STRAP STAY CLOSE APPROACH LATEX FREE LOT NUMBER MANUFACTURER DATE OF MANUFACTURE MEDICAL DEVICE MODEL NUMBER MR CONDITIONAL MR UNSAFE SERIAL NUMBER SINGLE PATIENT - MULTIPLE USE DO NOT LAUNDER UNIQUE DEVICE IDENTIFIER PATIENT WEIGHT LIMIT 2 | HoverTech T-BurgManual, Rev.F T-BurgTM User Manual DECLARATION OF CONFORMITY This product conforms to the requirements of Medical Devices Regulation (2017/745). Intended Use and Precautions INTENDED USE The HoverMatt® T-BurgTM is intended for all surgical procedures where a patient may be placed in Trendelenburg (or Reverse Trendelenburg) up to 40 degrees, including with use of robotics. Patient transfer / repositioning / boosting can be facilitated before and / or after the procedure where the patient's weight might place staff at risk for injury. The HoverMatt T-Burg is designed to securely hold a patient in varying degrees of Trendelenburg, up to 40 degrees. The HoverTech Air Supply inflates the HoverMatt T-Burg to cushion and cradle the patient, while air simultaneously escapes from the holes on the underside, reducing the force needed to transfer and move a patient by 80-90% to a stretcher or hospital bed. This can ease the patient transfer from pre-op to the O.R. Table, and following the procedure from the O.R. Table to PACU. The HoverMatt T-Burg is a highly breathable, open cell design that supports an ideal microclimate allowing the Mat to stay under a patient following surgery. It is recommended that the HoverCoverTM Disposable Absorbent Cover (or equivalent) be placed under the patient after surgery if the Mat is soiled. I N D I C AT I O N S · Patients who will be put into the Trendelenburg (or Reverse Trendelenburg) position with or without Lithotomy or Tilt. · Patients who are unable to assist in lateral transfer, repositioning and / or boosting. · Patients whose weight or girth poses a potential health risk for the caregiver(s) responsible for re/positioning and/or laterally transferring said patient. C O N T R A I N D I C AT I O N S · Patients over 400 lbs (182 kgs). Patients that have unstable thoracic, cervical or lumbar fractures should not use the HoverMatt T-Burg unless a clinical decision has been made by your facility. INTENDED CARE SETTINGS · Hospitals, Acute Care, or Surgery Centers PRECAUTIONS TRENDELENBURG (REVERSE) POSITION (WITH OR WITHOUT TILT) · Caregivers must verify that all connecting straps are tightly connected to the O.R. table to ensure the HoldFastTM Strip is in contact with the O.R. Table. · Attach patient safety (body) straps across the patient. THE PATIENT'S SKIN MUST MAKE DIRECT CONTACT WITH THE HOLDFASTTM SURFACE. PRECAUTIONS O.R. TO PACU TRANSFERS · Caregivers must verify that all caster brakes have been engaged prior to transfer. · Use a minimum of three caregivers during air-assisted lateral patient transfers. · Never leave the patient unattended when the device is inflated. · Use this product only for its intended purposes, as described in this manual. · Only use attachments and/or accessories that are authorized by HoverTech. · When transferring to a low air loss bed, set the bed mattress air flow to the highest level for a firm transfer surface. · Never attempt to transfer a patient on an uninflated HoverMatt T-Burg. Prior to moving a patient into a Trendelenburg (or Reverse Trendelenburg) position, ensure (i) that the Mat is deflated and (ii) the Mat is secured to the O.R. table per instructions on pg.5, and (iii) that the patient is secured to the Mat and O.R. Table itself per hospital guidelines and (iv) ensure the instructions are followed and in accordance with hospital knowledge, practices and guidelines for placing patients safely in Trendelenburg. PRECAUTIONS AIR SUPPLY · Not for use in the presence of flammable anesthetics or in a hyperbaric chamber or oxygen tent. · Route the power cord in a manner to ensure freedom from hazard. · Avoid blocking the air intakes of the HT-Air® Air Supply. · When using the HoverMatt T-Burg in an MRI environment, a 25 ft. specialty MRI hose is required (purchased separately). Avoid electric shock. Do not open Air Supply container. Reference your Air Supply's product-specific user manual for operating instructions. PRECAUTIONS MRI · The HoverMatt T-Burg is MR conditional by rationale. The device is made from all non-ferrous materials. As a result, MR safety testing was not performed. Based on rationale, the HoverMatt T-Burg is electronically non-conductive and non-magnetic. · When using a HoverMatt T-Burg in an MRI environment a 25 ft. specialty MRI hose is required, thus making these products MRI conditional. The HoverTech air supply and regular hose are conductive and magnetic and are MR Unsafe. Do not exceed a 40° angle. T-BurgManual, Rev.F www.HoverTechInternational.com | 3 T-BurgTM User Manual Part Identification HoverMatt® T-BurgTM Foot-end Perineum Cut-out Rail Fasteners (3 per side) Foot-end Straps (1 per side) Lift Sheet Transfer Handles (2 per side) HoldFastTM Strip (1 per side) Product Specifications/Required Accessories HOVERMATT® T-BURGTM AIR TRANSFER MATTRESS Material: Construction: Top: breathable open celled, elastomeric foam Bottom: High MVTR Nylon twill Sewn Width: 34" (86 cm) Length: 45" (114 cm) HoverMatt T-Burg Model #: HM-TBURG-34" W x 45" L (5 per box)* Model #: HM-TBURG-34-KIT -" W x 45" L (5 + 5 pair arm protectors per box)* HoldFastTM surface Head end Patient Safety (Body) Strap (2 parts) Fastening Strip (1 per side) WEIGHT LIMIT 400 LBS/ 181 KG *Breathable model REQUIRED ACCESSORY: Model #: HTAIR1200 (North American Version) 120V~, 60Hz, 10A Model #: AIR200G (800 W) 120V~, 60Hz, 10A Model #: AIR400G (1100 W) 120V~, 60Hz, 10A 4 | HoverTech T-BurgManual, Rev.F T-BurgTM User Manual Transfer from PACU to Operating Room (O.R.) Table 1. Patient should preferably be in a supine position. 2. Place patient centered on the HoverMatt T-Burg with buttocks aligned with the perineum cutout. 3. Ensure the transfer surfaces (stretcher / bed to O.R. Table) are as close as possible (lock all wheels). 4. Plug the HoverTech Air Supply power cord into an electrical outlet. 5. Insert hose nozzle into a hose port at foot-end of HoverMatt T-Burg (snap into place). 6. Turn on HoverTech Air Supply. 7. Push HoverMatt T-Burg at an angle, either headfirst or feetfirst, across the surfaces. Once half-way across, caregiver on the receiving side should grasp closest handles and pull to desired location. Ensure caregiver at the foot-end guide the patient's feet during the transfer. 8. Ensure patient is centered on the O.R Table with the HoverMatt T-Burg and patient aligned with the O.R. Table perineum cutout prior to deflation. 9. Turn off HoverTech Air Supply. 10. Follow instructions for Attaching to O.R. Table below. ALWAYS USE A MINIMUM OF THREE CAREGIVERS WHEN USING THE HOVERMATT T-BURG. Attaching to Operating Room Table 1. Start with table flat and without tilt. 2. Ensure O.R. Table pad is properly attached to O.R. Table. 3. Place HoverMatt T-Burg on O.R. table. 4. Lift sheet may be used for patient repositioning and/or to keep the arms adducted against the patient's body. 5. Ensure that the HoldFast (grey) foam and the perineum cutout are centered on the O.R. Table. The perineum cutout will be slightly above the cutout of the O.R. Table. 6. Tuck the sides of the Matt under the O.R. Table Pad, ensuring that the bottom HoldFastTM Strip is flat against the O.R. Table. T-BurgManual, Rev.F www.HoverTechInternational.com | 5 T-BurgTM User Manual Attaching to Operating Room (O.R.) Table (Cont.) 7. Select one of the following two methods to attach the HoverMatt T-Burg to the O.R. table: Method 1 Loop the rail fasteners (3 per side) behind the nearest rail post and attach to the fastening strip for Trendelenburg (for Reverse Trendelenburg in front of the closest rail post). Rail Post The rail strap can be placed directly to the fastening strip or double looped around the rail post before attaching to the fastening strip to accommodate varying O.R. Table configurations. OR Method 2 Loop the rail fasteners (3 per side before or after the rail post and attach to the fastening strip for Trendelenburg (or Reverse Trendelenburg). The rail strap can be placed directly to the fastening strip or double looped around the rail post before attaching to the fastening strip to accommodate varying O.R. Table configurations. 6 | HoverTech T-BurgManual, Rev.F T-BurgTM User Manual Attaching to Operating Room (O.R.) Table (Cont.) 8. Loop the foot-end straps around the footboard post, stirrups or other point on the O.R. Table for both methods. Note: Footboard post is shown in up position to visualize the attached strap. 9. Ensure Matt lies flat (no wrinkles) prior to placing patient on the HoverMatt T-Burg. T-BurgManual, Rev.F www.HoverTechInternational.com | 7 T-BurgTM User Manual Attaching to Operating Room (O.R.) Table (Cont.) WARNINGS: Ensure the HoverMatt T-Burg is firmly attached to the O.R. table before patient is positioned for surgery. Ensure hospital protocols are followed for patients being placed in Trendelenburg position. Before using HoverMatt T-Burg , ensure the O.R. table pad is securely affixed to the O.R. table. Be sure to follow your facility's policies and guidelines for frequency of patient monitoring. Check for skin integrity and proper circulation. Product is to be used by a licensed medical professional only. 10. Ensure patient's buttocks region is as close as possible to the perineum cutout at the bottom of the Matt. 11. Ensure that as much of the patient's skin as possible is in direct contact with the HoldFastTM foam. 12. Loop one of the patient safety (body) straps behind the O.R. Table rail and back onto the strap per the label. Repeat on the other side. 13. Bring straps across patient's chest and attach securely to each other to secure patient to table and Matt. 8 | HoverTech T-BurgManual, Rev.F T-BurgTM User Manual Attaching to Operating Room (O.R.) Table (Cont.) 14. Place arm protectors (purchased separately) around each arm. Ensure that arms are securely positioned against the patient's body per hospital procedures/protocols. 14a. The lift sheet may be placed over or under the patients arm and back under the body to keep the arm adducted against the patient's body. 15. Position table and patient for the procedure. 16. Following procedure, return patient to a supine (flat) position FOLLOWING SURGERY (PROCEDURE) 1. Disconnect HoverMatt T-Burg from O.R. Table by loosening rail fastener straps and foot-end straps. Reconnect footplate and headboard, if applicable. Take patient's legs out of stirrups, if applicable. 2. Ensure that any portion of the HoverMatt T-Burg that may be tucked under the OR Table pad is untucked 3. Plug the HoverTech Air Supply power cord into an electrical outlet. 4. Insert the hose nozzle into either of two hose ports at foot end of HoverMatt and snap into place. 5. Ensure that transfer surfaces are as close as possible and lock all wheels. 6. If possible, transfer from a higher surface to a lower surface. Turn on HoverTech Air Supply. 7. Push HoverMatt at an angle headfirst. Once half-way across, opposite caregiver should grasp closest handles and pull to desired location. Ensure caregiver at foot end guides patient's feet during the transfer. 8. Ensure patient is centered on receiving surface prior to deflation. 9. Turn off Air Supply and employ the bed/stretcher rails. T-BurgManual, Rev.F www.HoverTechInternational.com | 9 T-BurgTM User Manual Part Identification HT-Air® Air Supply HT-Air® Keypad Functions Adjustable Speed Indication (Green Flashing LED) Power Indication Green LEDs Power Cord Strap Hose Release Button Control Panel Label Power Cord (US/UK/Euro) Carrying Handle/ Attachment Hook Hose Nozzle Hose Air Filter Cover The HT-Air is not for use with the HJBSC-200 HoverJack Battery Cart. Adjustable/ Pressure Setting Transfer Speed High Standby (Amber LED) Transfer Speed Low ADJUSTABLE: For use with HoverTech air-assisted positioning devices. There are four different settings. Each press of the button increases the air pressure and rate of inflation. The Green Flashing LED will indicate the inflation speed by the number of flashes (i.e. two flashes equals the second inflation speed). All of the settings in the ADJUSTABLE range are substantially lower than the HoverMatt and HoverJack settings. The ADJUSTABLE function is not to be used for transferring. The ADJUSTABLE setting is a safety feature that can be used to ensure the patient is centered on HoverTech air-assisted devices and to gradually accustom a patient who is timid or in pain to both the sound and functionality of the inflated devices. STANDBY: Used to stop inflation/air flow (Amber LED indicates STANDBY mode). HOVERMATT 28/34: For use with 28" & 34" HoverMatts and HoverSlings. HOVERMATT 39/50 & HOVERJACK: For use with 39" & 50" HoverMatts and HoverSlings and 32" & 39" HoverJacks. Air200G/Air400G Air Supplies If using HoverTech's Air200G or Air400G Air Supplies, press the grey button on the top of the canister to initiate air flow. Press the button again to stop air flow. 10 | HoverTech T-BurgManual, Rev.F T-BurgTM User Manual Cleaning & Maintenance This is a disposable product. The HoverMatt T-Burg is a single-patient use device and should not be laundered. AIR SUPPLY CLEANING AND MAINTENANCE See air supply manual for reference. NOTE: CHECK YOUR LOCAL/STATE/FEDERAL/INTERNATIONAL GUIDELINES BEFORE DISPOSAL. HOVERMATT T-BURG CLEANING AND MAINTENANCE Prior to use, a visual inspection should be performed on the HoverMatt T-Burg to ensure that there is no visible damage that would render the Mat unusable. The HoverMatt T-Burg should have all of its patient safety straps and handles (reference the Part Identification section on pg. 3 for all appropriate parts). There should be no tears or holes that would prevent the Mat from inflating. If any damage is found that would cause the system not to function as intended, the Mat should be removed from use. T-BurgManual, Rev.F www.HoverTechInternational.com | 11 T-BurgTM 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://hovertechinternational.com/standard-product-warranty/ HoverTech 4482 Innovation Way Allentown, PA 18109 www.HoverTechInternational.com Info@HoverTechInternational.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. 12 | HoverTech T-BurgManual, Rev.F 4482 Innovation Way Allentown, PA 18109 800.471.2776 Fax 610.694.9601 HoverTechInternational.com Info@HoverTechInternational.com