Medical Device CE marking - CEpartner4U
TapMed Swiss AG - TapMed Swiss AG
User Manual for HOVERTECH models including: Q2Roller Lateral Turning Device, Q2Roller, Lateral Turning Device, Turning Device
Use as a Post-Prone Positioning Device in leu of pillows, foam, or gel positioners. • Assist patients to sit on the edge of the bed. CONTRAINDICATIONS.
File Info : application/pdf, 8 Pages, 1.75MB
DocumentDocumentLateral Turning Device User Manual Visit www.HoverMatt.com for other languages TABLE OF CONTENTS Symbol Reference ..........................................................2 Intended Use and Precautions........................................3 Part Identification - Q2Roller ..........................................3 Part Identification - Air Supply ........................................3 Air Supply Keypad Functions..........................................4 Instructions for Use ........................................................4 Product Specifications/Required Accessories..................5 Cleaning & Maintenance ...............................................6 Returns and Repairs........................................................7 User Manual Symbol Reference CE MARKING OF CONFORMITY UK MARKING OF CONFORMITY AUTHORIZED REPRESENTATIVE UK responsible person Switzerland AUTHORIZED REPRESENTATIVE CAUTION / WARNING IMPORTER DISPOSAL OPERATING INSTRUCTIONS USE TWO CAREGIVERS LOCK ALL WHEELS LATEX FREE LOT NUMBER MANUFACTURER DATE OF MANUFACTURE MEDICAL DEVICE SINGLE PATIENT - MULTIPLE USE Do not launder UNIQUE DEVICE IDENTIFIER PATIENT WEIGHT LIMIT 2 | HoverTech Q2RollerManual Rev. I User Manual Intended Use and Precautions INDICATIONS FOR USE · Assist patients who are unable to turn or laterally position themselves. · Patients that need Q2 turning for off-loading pressure. · Use as a Post-Prone Positioning Device in leu of pillows, foam, or gel positioners. · Assist patients to sit on the edge of the bed. C O N T R A I N D I C AT I O N S Patients who are experiencing thoracic, cervical or lumbar fractures that are deemed unstable. INTENDED CARE SETTINGS Hospitals, long-term or extended care facilities. PRECAUTIONS · Ensure the Q2Roller meets the patient's needs and use clinical judgement in using the Q2Roller. · It is recommended to use a minimum of two caregivers when operating the Q2Roller. However, one caregiver may operate the Q2Roller if side rails are raised. · Ensure valves are not in contact with the patient while on the Q2Roller. · Product is single-patient use and should only be used by trained personnel. · Only use attachments and/or accessories that are authorized by HoverTech. · Use the Q2Roller according to instructions. · Make sure patient is centered on the Q2Roller before inflating using the Reference Center Line Indicator on the Q2Roller. · Caregivers must ensure patient is attended and stabilized during Q2Roller inflation, deflation, or when inflated at angles greater than 30 degrees. · Do not launder. · Reference product-specific user manuals for additional operating instructions. Only for use with the HT-Air air supply adjustable button. PRECAUTIONS HOVERTECH AIR SUPPLY · Route the power cord in a manner to ensure freedom from hazard. · Avoid blocking the air intakes of the air supply. · Use this product only for its intended purpose as described in this manual. Avoid electric shock. Do not open air supply. Q2RollerManual Rev. I www.HoverMatt.com | 3 User Manual Part Identification - Q2Roller Center Line Indicator Securing Apron Turning Chambers Red Deflation Valve (2) Black Inflation Valve (2) 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 Intake Filter Cover WARNING: The HT-Air is not compatible with DC power supplies. The HT-Air is not for use with the HoverJack Battery Cart. Adjustable/ Pressure Setting Standby (Amber LED) Transfer Speed Low Transfer Speed High The ADJUSTABLE keypad function has 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). STANDBY: Used to stop inflation/air flow (Amber LED indicates STANDBY mode). 4 | HoverTech Q2RollerManual Rev. I User Manual Instructions for Use To Laterally Turn a Patient: 1. Ensure the red deflation valves are capped tightly before beginning inflation. 2. Place the Q2Roller on the bed mattress and center using the Center Line Indictor. 3. Tuck the securing apron of the Q2Roller under the bed mattress to keep it in place during use. 4. Center an absorbent pad on top of the Q2Roller (if the patient is already on the mattress, place the device and pad under the patient using a log-rolling technique). 5. With the patient centered on the device, ensure all bed/stretcher rails are up, or follow your facility's protocol. 6. Locate the inflation valve on the OPPOSITE side of the turn direction, and place the air supply hose over the valve. Press the ADJUSTABLE button on the HT-Air keypad to initiate air flow. If necessary, press this button up to 3 more times to increase air flow and rate of inflation. 7. When the turn is complete, remove the hose from the valve and press the STANDBY button on the air supply keypad to stop air flow. Chamber may not need to be fully inflated to achieve desired position. 8. To quickly deflate the Q2Roller, remove the red cap from the deflation valve. To slowly deflate or adjust the chamber, depress the center of the black inflation valve. To Use as a Post-Prone Positioning Device: 1. Follow steps 1-4 above. 2. Prepare the patient for proning. 3. Prone patient onto the Q2Roller and ensure patient is centered. 4. Inflate and adjust chambers to fully offload pressure and place patient in proper prone position per your facility's protocol. Do not use Q2Roller to prone. Use other measures to prone patient - For Post-Prone Positioning only. To Sit a Patient Up on the Edge of the Bed: Use a minimum of 2 caregivers. Use clinical judgement to determine if the patient is capable and ready to sit on the edge of the bed. 1. Follow steps 1-4 to laterally turning a patient. 2. With 1 caregiver on each side of the patient, fully inflate the chamber on the opposite side of where patient will ultimately be seated to completely turn the patient. Bend the patient's knees for comfort. 3. Raise the head of the bed as high as it will go then lower the bed so that the patient's feet will touch the floor when seated at the edge of the bed. Both caregivers can now attend to the patient on the same side as the fully inflated chamber is supporting the patient's back. 4. One caregiver will assist with sliding the patient's legs to the side of the bed while the other is fully inflating the deflated chamber to ensure the patient does not slide off the edge of the bed. 5. Once the chamber is fully inflated and the patient is sitting upright, stabilize the patient and then open the deflate valve. As the chamber deflates, ensure the patient is still sitting upright. The leg caregiver will continue to guide the legs to the edge of the bed as the chamber is fully deflated. Stabilize the patient. Q2RollerManual Rev. I www.HoverMatt.com | 5 User Manual Product Specifications/Required Accessories Q2ROLLER® L ATERAL TURNING DEVICE HoverCover Half Size Material: Construction: Width: Length: Polyurethane Laminated Non-Woven, Nylon Non-Woven RF Welded Chambers: 46.5" (118 cm) (combined chamber width) Apron: 72" (183cm) Chambers: 44.5" (113 cm) Apron: 44" (112 cm) Material: Construction: Width: Length: Non-Woven, Breathable PE Thermal Bonding 40" (101 cm) 40" (101 cm) Model #: HTR-CHX-CASE (50 ea.) Model #: HTR-200 LIMIT 600 LBS/ 272 KG Single-Patient Use Latex Free REQUIRED ACCESSORY: Model #: HTAIR1200 (North American Version) 120V~, 60 Hz, 10A Model #: HTAIR2300 (European Version) 230V~, 50 Hz, 6A Model #: HTAIR1000 (Japanese Version) 100V~, 50/60 Hz, 12.5A Model #: HTAIR2356 (Korean Version) 230V~, 50/60 Hz, 6A Cleaning & Maintenance CLEANING The Q2Roller is a single-patient use device. If the device becomes soiled, completely wipe it down using a germicidal cleaner (phenolic disinfectant, quaternary solution or other intermediate level disinfectant according to facility procedure) to disinfect. For best results, follow the cleaner manufacturer's recommended dwell time and instructions for use. Apply germicidal cleaner directly into hard-to-reach areas. Let air dry. Do not launder. INFECTION CONTROL The HoverCover Half Size is recommended to cover the Q2Roller to keep the device from getting soiled (also available for separate purchase). Other materials, such as pads or linens, may also be placed on top of the Q2Roller to keep it clean. If the Q2Roller is used on an isolation patient, the hospital should employ the same protocols/procedures it utilizes for the bed mattress and/or for the linen in that patient room. AIR SUPPLY CLEANING AND MAINTENANCE See air supply manual for reference. NOTE: CHECK YOUR LOCAL/STATE/FEDERAL/INTERNATIONAL GUIDELINES BEFORE DISPOSAL. PREVENTIVE MAINTENANCE Prior to use, a visual inspection should be performed on the Q2Roller to ensure that there is no visible damage that would render the Q2Roller unusable. The Q2Roller should be periodically inspected to ensure the following: · All inflation valves are self-sealing with no evidence of leakage · There are no punctures or tears in the Q2Roller If any damage is found that would cause the Q2Roller not to function as intended, the Q2Roller should be discarded. 6 | HoverTech Q2RollerManual Rev. I 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. Q2RollerManual Rev. I www.HoverMatt.com | 7 4482 Innovation Way Allentown, PA 18109 800.471.2776 Fax 610.694.9601 www.HoverMatt.com Info@HoverMatt.com