Inogen Rove 4 IS-401 User Manual

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Inogen Rove 4

™

PORTABLE OXYGEN

CONCENTRATOR

System Catalog: IS-401

Concentrator Catalog: IO-401

USER

MANUAL

ENGLISH

Caution: USA Federal law restricts this

device to sale by or on the order of a

physician. May also be applicable in

other countries.

96-11126-00-02 C | Page 1 of 40

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Page 1 Inogen Rove 4 ™ PORTABLE OXYGEN CONCENTRATOR System Catalog: IS-401 Concentrator Catalog: IO-401 USER MANUAL ENGLISH Caution: USA Federal law restricts this device to sale by or on the order of a physician. May also be applicable in other countries.
Page 2: Glossary Of Symbols
(operating) Contents Electrical Safety Agency Certificate Authorized Representative in Switzerland CH REP For icons displayed on the user interface panel Product Catalog Description refer to section 7. ©2023 Inogen, Inc. All rights reserved. Page 2 of 40 96-11126-00-02 C...
Page 3: Table Of Contents
1. PRODUCT CONTENT AND QUICK START GUIDE ............4 2. INTRODUCTION ......................... 5 3. INDICATIONS AND INTENDED USE ................. 5 4. SAFETY INSTRUCTIONS ....................6 5. INOGEN ROVE 4 DESCRIPTION..................9 6. GENERAL INSTRUCTIONS ....................10 7. ALARM INDICATORS & DEVICE ICON GLOSSARY ............18 8. TROUBLESHOOTING....................... 24 9.
Page 4: Product Content And Quick Start Guide
IMPORTANT: The Quick Start Guide is for reference ONLY. It is imperative to read the complete user manual before use. Before getting started, confirm that your Inogen Rove 4™ Portable Oxygen Concentrator system includes the following components: 1x DC Power Cable...
Page 5: Introduction
This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting. 3.2 INDICATIONS FOR USE AND CLINICAL BENEFIT The Inogen Rove 4™ is used on a prescriptive basis by patients requiring supplemental oxygen to increase blood oxygen saturation. 3.3 CONTRAINDICATIONS This device is to be used as an oxygen supplement and is NOT INTENDED to be life sustaining or life supporting.
Page 6: Safety Instructions
Use only water-based lotions or salves that are • The Inogen Rove 4™ is MR unsafe. Do not oxygen-compatible during setup or use during expose to MRI equipment or other devices that oxygen therapy.
Page 7 95% is expected to adversely affect the flow instructions for use are at the sole responsibility rate and the percentage of oxygen and for the patient. Inogen assumes no liability for consequently the quality of the oxygen therapy. use of parts and accessories not mentioned in Use of this device immediately after storage in these instructions for use.
Page 8 Doing so will minimize be able to consistently trigger the device to the risk of interrupting operation and will keep receive oxygen therapy. alarms functioning. ©2023 Inogen, Inc. All rights reserved. Page 8 of 40 96-11126-00-02 C...
Page 9: Inogen Rove 4 Description
AC power supply, DC power cable, rechargeable battery pack(s) and carry bag. This section is intended to help familiarize you with the device’s components and interface. Do not perform any actions on or with your POC until after reading Section 6.1, OPERATING Inogen Rove 4™. Display...
Page 10: General Instructions
DO NOT USE near pollutants, smoke, fumes, flammable anesthetics, cleaning agents or chemical vapors. DO NOT USE in environments where your concentrator could become submerged in water. DO NOT USE near oil grease or petroleum-based products. ©2023 Inogen, Inc. All rights reserved. Page 10 of 40 96-11126-00-02 C...
Page 11 • Connect the nasal cannula tubing by inserting it onto the metal cannula barb on the top of the device. IMPORTANT: Consult your physician if additional titration may be needed to ensure proper oxygen delivery when using a particular cannula. ©2023 Inogen, Inc. All rights reserved. Page 11 of 40 96-11126-00-02 C...
Page 12 • Press and hold the Power button until you hear a single short beep. The display will light up and the Inogen logo will appear on the display. IMPORTANT: If the display light immediately turns off after the Inogen logo appears, you have not held the power button long enough.
Page 13 Not all accessories are included with your system and can be purchased separately. The following optional accessories and replacement parts can be purchased from the manufacturer at www.inogen.com or by calling 1-877-466-4364. Description Item...
Page 14 If the battery is drained, charge the battery by plugging the device into external power or charging it with the external battery charger. ©2023 Inogen, Inc. All rights reserved. Page 14 of 40 96-11126-00-02 C...
Page 15: Nasal Cannula
Nasal cannula should be rated for 4 liters per minute to ensure proper oxygen delivery. Note that cannulas may be rated in “liters per minute” even though your prescribed pulse dose setting number does not represent a constant flow in liters per minute. ©2023 Inogen, Inc. All rights reserved. Page 15 of 40 96-11126-00-02 C...
Page 16 3. Connect the power charger by sliding it output plug into the onto the battery until it external battery audibly clicks and locks charger. onto the battery. ©2023 Inogen, Inc. All rights reserved. Page 16 of 40 96-11126-00-02 C...
Page 17 DO NOT store in temperatures less than 41˚F (5˚C) or higher than 95˚F (35˚C) for extended periods of time. DO NOT place objects on top of the concentrator or packaged concentrator. ©2023 Inogen, Inc. All rights reserved. Page 17 of 40...
Page 18: Responding To Alarms
(OFF). This is the default condition. 7.3 BLUETOOTH ICONS (FOR MODELS WITH BLUETOOTH) Bluetooth turned off. Bluetooth turned on. Pairing with Inogen Connect application. Concentrator unpaired from mobile device. ©2023 Inogen, Inc. All rights reserved. Page 18 of 40 96-11126-00-02 C...
Page 19 Data log transfer in progress or update in progress (app only): This icon is displayed during all data log transfers and software updates initiated through the Inogen Connect App. Data log transfer success (app only): This icon is displayed after data log transfers have been successfully completed through the Inogen Connect App.
Page 20: Alarm Log
To access the alarm log, ensure the concentrator is plugged and turned off. Then hold the plus (+) button for 5 seconds. Alternatively, the alarm log can be found in the advanced tab of the Inogen Connect App under error recall.
Page 21 What To Do Attach an external power supply turn Battery low, attach plug: Battery power is low with less off and insert a fully charged battery. than 10 minutes remaining. ©2023 Inogen, Inc. All rights reserved. Page 21 of 40 96-11126-00-02 C...
Page 22 Oxygen error: Oxygen output If condition persists, switch to your concentration has been below backup oxygen source and contact 50% for 10 minutes. your equipment provider to arrange for service. ©2023 Inogen, Inc. All rights reserved. Page 22 of 40 96-11126-00-02 C...
Page 23 System Error: The concentrator Switch to backup oxygen source will shut down and stop and contact your equipment producing oxygen. provider. ©2023 Inogen, Inc. All rights reserved. Page 23 of 40 96-11126-00-02 C...
Page 24: Troubleshooting
9.1 PAIRING YOUR DEVICE WITH THE MOBILE APPLICATION 1. Download the Inogen Connect App • On your smart phone or tablet, search for ‘Inogen Connect’ in the App Store (Apple) or Google Play (Android). 2. Put the device in standby mode •...
Page 25: Cleaning, Care And Maintenance
• Make sure to keep your app updated • Make sure to enable passwords • Turn off the concentrator’s Bluetooth when not paired with the Inogen Connect App 10. CLEANING, CARE AND MAINTENANCE Operator should perform periodic visual inspection of the device.
Page 26: Cannula Replacement
2. Remove the particle filters from both intake ends of the device. 3. Clean the particle filters with a mild liquid detergent and water, rinse in water and dry fully before reuse. To purchase additional particle filters, contact your equipment provider or Inogen. ©2023 Inogen, Inc. All rights reserved.
Page 27 7. Remove the columns completely from the device by pulling outward. 8. Both columns are removed as one piece. 9. To install new columns, first remove the four (4) dust caps from the new columns. ©2023 Inogen, Inc. All rights reserved. Page 27 of 40 96-11126-00-02 C...
Page 28: Battery Care And Maintenance
14. Turn clockwise until columns lock into place. Do not overtighten. IMPORTANT: You need to notify the device that you have replaced the columns. This can be done through the device itself or through the Inogen Connect App. 15. Resetting the columns through the device a.
Page 29: Device Repair And Disposal
11.1 REPAIR Do not attempt to repair the device unless otherwise specified in these instructions for use. Contact your equipment provider or Inogen for assistance. 11.2 DISPOSAL Follow your local governing ordinances for disposal and recycling of the device, accessories and packaging.
Page 30: Technical And Product Specifications
12. TECHNICAL AND PRODUCT SPECIFICATIONS 12.1 SPECIFICATIONS Inogen Rove 4™ Portable Oxygen Concentrator (Model # IO-401) Dimensions with BA-400 (4-cell) battery 5.9 x 2.7 x 7.5 in (15.0 x 6.8 x 19.0 cm) Dimensions with BA-404 (4-cell) battery 5.9 x 2.7 x 7.8 in (15.0 x 6.7 x 19.9 cm) Dimensions with BA-408 (8-cell) battery 5.9 x 2.7 x 8.1 in (15.0 x 6.8 x 20.6 cm)
Page 31 Type BF components Against Electrical Shock Not intended for cardiac application Degree of Protection IP22 12.2 PULSE VOLUME FLOW SETTINGS Inogen Rove 4™ Pulse Volumes per Flow Setting (mL/breath +/- 15% per ISO 80601-2-67) BREATHS PER MINUTE 21.0 42.0 63.0 84.0 14.0...
Page 32: Electromagnetic Compatibility (Emc) Information
The Concentrator is intended for use in the electromagnetic environment of home, institution and transport modalities. The user of the Concentrator should make sure it is used in such an environment. During the immunity testing specified below the Inogen Rove 4™ will continue to deliver oxygen within specification. ©2023 Inogen, Inc. All rights reserved.
Page 33: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
0 °, 45 °, 90 °, 135 °, institution and transportation and mobile environments. voltage variations 180 °, 225 °, 270 °, and If the user of the Inogen Rove 4™ requires continued on power supply 315 °. operation during power mains interruptions, it is...
Page 34: Wireless Communication, Specifications And Compliance
See FCC, Canada and Taiwan statements 13.2 TRANSMITTER APPROVAL INFORMATION Country Approval United States FCC ID: A8TBM71S2 Canada ISED: - IC: 12246A-BM71S2 - HVIN: BM71BLES1FC2 Europe Korea KCC: MSIP-CRM-mcp-BM71BLES1FC2 ©2023 Inogen, Inc. All rights reserved. Page 34 of 40 96-11126-00-02 C...
Page 35 • This device must accept any interference, including interference that may cause undesired operation of the device. Taiwan 注意 ! 依據低功率電波輻射性電機管理辦法第十二條經型式認證合格之低功率射頻電機，非經許可，公司、商號或使用者均不得擅自變更頻率、加大功率或變更原設計之特性及功能。第十四條低功率射頻電機之使用不得影響飛航安全及干擾合法通信；經發現有干擾現象時，應立即停用，並改善至無干擾時方得繼續使用。前項合法通信，指依電信規定作業之無線電信。低功率射頻電機須忍受合法通信或工業、科學及醫療用電波輻射性電機設備之干擾。 ©2023 Inogen, Inc. All rights reserved. Page 35 of 40 96-11126-00-02 C...
Page 36: Limited Warranty Statement
Inogen’s sole liability and Customer’s sole and exclusive remedy arising out of or relating to the Products, including for a breach of warranty, is limited to, at Inogen’s sole option, repair or replacement of the Product or part thereof which is returned at Customer’s expense to Inogen. This warranty shall apply only if Customer notifies Inogen in writing of the defective Product promptly after the discovery of the defect and within the warranty period.
Page 37: Contact Information
16. CONTACT INFORMATION If you have questions about the information in these instructions or about the safe operation of this device, contact your equipment provider or Inogen, Inc. 859 Ward Drive, Suite 200, Goleta, CA 93111, USA, 1-877-466-4362. Healthcare Professionals: To report an adverse experience with a specific Inogen product, please call the Inogen Customer Care Center at 1-877-466-4364.
Page 40 Inogen, Inc. 859 Ward Drive, Suite 200 Goleta, CA 93111, USA Toll Free: 877-466-4362 +1-805-562-0515 (Outside the USA) E-mail: info@inogen.net www.inogen.com USA United States NOVEMBER/2023 ©2023 Inogen, Inc. All rights reserved. Page 40 of 40 96-11126-00-02 C...

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Inogen Rove 4 IS-401 User Manual

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