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Instructions for Use
DVT Compression System
No Tubes
or Cords
Model No. 08-0042, 08-0043, 08-0044, 07-0013-01 • ©2021 Ortho8 Inc.
Document #IFU - VenaOne 04-0019 Rev D June 2022
Customer Support: (800) 604-2487 • info@Ortho8.com • www.Ortho8.com •
Ortho8 Inc., 2217 Plaza Drive, Rocklin, CA 95765
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner
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Table of Contents
Related Manuals for Ortho8 vera one 08-0042
Summary of Contents for Ortho8 vera one 08-0042
- Page 1 DVT Compression System No Tubes or Cords Model No. 08-0042, 08-0043, 08-0044, 07-0013-01 • ©2021 Ortho8 Inc. Document #IFU - VenaOne 04-0019 Rev D June 2022 Customer Support: (800) 604-2487 • info@Ortho8.com • www.Ortho8.com • Ortho8 Inc., 2217 Plaza Drive, Rocklin, CA 95765...
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Page 2: Table Of Contents
Table of Contents VENAONE OVERVIEW CONTRAINDICATIONS FEATURES AND BENEFITS SYMBOLS SYSTEM CONTENTS BATTERY INDICATOR & CHARGING APPLICATION INSTRUCTIONS PUMP ALARM LEGEND DEVICE HANDLING CLEANING AND DISINFECTING DISPOSAL USER MAINTENANCE STORAGE ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES TECHNICAL DATA WARNINGS CAUTIONS... -
Page 3: Venaone Overview
VENAONE OVERVIEW Pneumatic compression is a clinically proven modality for reducing the risks associated with deep vein thrombosis. VenaOne is a tubeless, portable, lightweight and battery-operated DVT compression system designed specifically for the acute-care setting. VenaOne aids in the prevention of DVT by helping to stimulate blood flow in the legs. -
Page 4: Features And Benefits
Features & Benefits Lightweight Portable Fully ambulatory and simple design. Weighs less than a pound. Easy One-Touch Operation Battery Operated Controls all functions with just the power button. ~24 hour battery life allows for ease of use and patient compliance. Infection Control Compression Device is designed to help reduce bacterial... -
Page 5: System Contents
System Contents VenaOne Single Device (No AC adapter/ 08-0042 08-0044 VenaOne, Replacement Device charger included. 08-0043 07-0013-01 VenaOne, Bulk Pack, Case of 20 Charging Station (2) Warning: ONLY USE WRAP(S) PROVIDED BY PRECISION MEDICAL PRODUCTS Systems are packaged in singles Data Port or cases of 20. -
Page 6: Battery Indicator & Charging
Battery Indicator & Charging Battery icon: Remains illuminated at all times during operation Solid Green all three Bars: 100% battery life remaining Solid Green Two Bars: 31% to 60% battery life remaining, third bar pulses until fully charged. Solid Green One Bar: 30% battery life remaining, second and third bar pulses alternately until 31% charged. -
Page 7: Application Instructions
Application Instructions REMOVE THE DEVICES PLACE THE DEVICE IN THE WRAP Remove the devices from the plastic The device and bladder will slide to the packaging. Note: the devices will come in bottom of the wrap. separate packaging. SEALING THE WRAP(S) CALF WRAP APPLICATION Once the device is placed inside the cuff, Apply the wrap around the calf and secure the... -
Page 8: Pump Alarm Legend
Pump Alarm Legend If the device is turned on after an alarm event, the LED displays the previous alarm. High Pressure “HP” In the unlikely event the device applies higher pressures than normal, a high pressure (HP) alarm will display. Power off and restart the system. If alarm persists, remove from service and replace. -
Page 9: Device Handling
Device Handling DO NOT DISPOSE OF THE DEVICE DISPOSE OF THE WRAP ONLY All contaminated products or accessories should be disposed of appropriately according to hospital policy and state law, taking environmental factors into consideration. When use is completed, or the patient is discharged, remove the device, and discard only the wraps. -
Page 10: Storage
Do not handle the leg cuffs with any sharp objects. If a bladder is punctured or you notice a leak, do not attempt to repair the device or cuffs. Replacement devices will be made available to you by your local sales representative. Avoid folding or creasing the bladder during the use and transportation of the devices. - Page 11 EMC GUIDANCE Warning: Don’t use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
- Page 12 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY The VenaOne is intended for use in the electromagnetic environment specified below. The customer or the user of the VenaOne should assure that it is used in such an environment. Immunity Test IEC 60601 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE TEST LEVEL...
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Page 13: Warnings
WARNINGS • The VenaOne wraps are designed for single radio frequency energy and, if not installed and used patient use only. in accordance with instructions, may cause harmful interference to other devices in the vicinity. However, • The device is to be used only by the patient there is no guarantee that interference will not occur prescribed, and only for its intended use. - Page 14 TOLERANCES: VenaOne for use in hospital settings. Pressure 10% Model No. 08-0042, 08-0043, 08-0044, 07-0013-01 • ©2021 Ortho8 Inc. Document #IFU - VenaOne 04-0019 Rev D June 2022 Customer Support: (800) 604-2487 • info@Ortho8.com • www.Ortho8.com • Ortho8 Inc., 2217 Plaza Drive, Rocklin, CA 95765...
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