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Inogen TAV Скачать руководство пользователя страница 35

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The information contained in this document is proprietary and confidential nature. No part of

this manual may be reproduced or transmitted for any purpose without the express written

permission of Inogen, Inc.
An electronic version of the Instructions for Use is available for download at www.tidalassist.com
96-09781-00-01 A User Manual TAV Trademarks and registered trademarks of Inogen, Inc.

Copyright Inogen, Inc. 2019. All rights reserved.

Index

Adverse Effects, 2
Alarms, 15
Altitude Compensation, 31
Battery – instructions, insertion, 5, 6
Battery Life, 21
Bypass Valve, 1, 14, 20
Cautions, 2
Cleaning, 16
Constant Flow Mode, 1, 13
Contraindications, 2
Customer Support, 17
Electromagnetic Emissions, 27
EMC Information, 27-30
Enclosure Rating, 21
Glossary, 1
Icons, 26
Intended Use, 2
Introduction, 1
Low Battery Indicator, 15
Maintenance, 16
Malfunction, 17
Model Number, 21
Nasal Pillow Interface – putting on, 9
Operating Temperature, 21
Oxygen Cylinder Duration

•

Pulse Mode, 23

•

Tidal Assist Mode, 24

•

Constant Mode, 25

Oxygen Delivery Performance

•

Pulse Mode, 22

•

Tidal Assist Mode, 22

•

Constant Mode, 22

Pulse Mode, 1, 11
RF Emissions, 27
Service Life, 21
Storage Temperature, 21
TAV® Regulator Adapter, 4, 7
TAV® System

•

Basic Device Operation, 10

•

Connecting to nasal pillow interface, 8

•

Connecting to oxygen, 7, 8

•

Controls and Indicators, 5

•

Major Components, 4

•

Using Pulse Mode, 11

•

Using Constant Mode, 13

•

Using the Bypass Valve, 14

•

Using Tidal Assist Mode, 12

Technical Specifications, 21
Technical Support, 17
Tidal Assist Mode, 1, 12
Tidal Volume, 1
Troubleshooting

•

Alarms, 19

•

General, 17

Warnings, 2
Weight and Dimensions, 21

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Содержание TAV

Страница 1: ...1 INSTRUCTIONS FOR USE ...

Страница 2: ...2 ...

Страница 3: ...on 10 Using Pulse Mode 11 Using Tidal Assist Mode 12 Using Constant Flow Mode 13 Using the Bypass Valve 14 Alarms and Low Battery Indicator 15 Cleaning and Maintenance 16 Device Cleaning and Maintenance 16 Nasal Pillow Interface Cleaning and Maintenance 16 General Troubleshooting 17 Alarm Troubleshooting 19 Technical Specifications 21 Oxygen Delivery Performance 22 Air Delivery Performance 23 Oxyg...

Страница 4: ...t EMC Electromagnetic compatibility see Appendix A Nasal Pillow Interface The TAV System uses a custom designed nasal pillow interface This special interface allows proper delivery of the special delivery modes available on the TAV Only the Inogen brand nasal pillow interface should be used with the TAV System Pulse Mode This mode is similar to the pulsed dose mode on other devices It provides a s...

Страница 5: ...s Not intended for use by patients who breathe more than 40 breaths per minute or patients who consistently fail to trigger the device The Tidal Assist flow setting 4 does not support a breath rate higher than 25 bpm and Tidal Assist flow setting 5 does not support a breath rate higher than 20 bpm The use of the Tidal Assist ventilation system requires moderate patient participation therefore you ...

Страница 6: ...s communications equipment such as wireless home network devices mobile phones cordless telephones and their base stations and walkie talkies can affect this equipment and should be kept a minimum distance away from the equipment per the separation distances indicated in the EMC section of this manual Appendix A Medical electrical equipment such as this device needs special precautions regarding e...

Страница 7: ...AA Battery Supply Tubing Regulator Adaptor sold separately Note The TAV System and battery contain electronic waste that requires appropriate disposal according to your local ordinances For use when connecting to DISS connectors or to hospital wall outlets ...

Страница 8: ...tery indicator Flow Alarm Nasal Pillow Interface Connector 2 lpm Bypass Valve Supply Tubing Connector Inserting the Battery Note Only AA alkaline batteries should be used Other battery types will not damage the system however the operating life may be less and the low battery indicator will be inaccurate Batteries with a voltage 2 5V should never be used as they may affect the accuracy of the elec...

Страница 9: ...both thumbs on the battery cover door Slide the battery door back until a slight click is felt Device Connections When looking at the front of the device the small connector on the bottom left side A is for connecting your nasal pillow interface The large connector on the bottom right side B is for connecting the supply tubing from the gas source see page 8 Connecting the Nasal Pillow Interface At...

Страница 10: ...o the gas source The TAV device is connected to standard DISS fittings using the Regulator Adapter accessory The Regulator Adapter must be used when connecting the TAV device to hospital wall oxygen Attach the TAV Regulator Adapter to the threaded DISS outlet of the gas source Hand tighten the connector until it is snug Always ensure the Regulator Adapter is connected to the TAV device before conn...

Страница 11: ... Supply Tubing TAV Logo 3 Turn the flow meter knob max counter clockwise when connected to the TAV See the concentrator s Instructions For Use IFU for operating instructions Note To ensure proper operation the TAV device must be connected to a TAV compatible oxygen concentrators Compatible concentrators are labeled with the TAV logo Turn the flow meter to Max when the TAV device is connected or th...

Страница 12: ... the interface tubing This step identifies the left side of the pillows interface 2 Hold the interface tubing limb with the offset in your left hand The openings of the nasal pillow interface will be facing you 3 Insert the pillows into your nose making sure each pillow is securely inside each nostril It may help to check and adjust the fit using a mirror 4 Use one hand to hold the pillows in your...

Страница 13: ...d flow setting 1 5 The green light for the selected flow rate will blink Each press on the buttons decreases or increases the flow setting by 1 unit 4 Turn the device OFF Press and hold the power button for 3 full seconds until the lights turn off and the device beeps twice The TAV system provides 3 modes of operation and 5 flow settings for each mode The mode and flow settings can be changed base...

Страница 14: ...etting 1 5 The green light for the selected flow rate will blink Each press on the buttons decreases or increases the flow rate setting by 1 unit Pulse Mode provides oxygen therapy similar to pulse dose or conserver type oxygen devices In Pulse Mode the TAV device provides a measured dose of oxygen at the start of each breath The amount of oxygen depends on the selected flow setting Before turning...

Страница 15: ...llow interface are connected Also make sure that the gas supply is turned on 1 Turn the device ON if off Press and hold the power button for 1 full second until the lights turn on and the device beeps 2 Select the breathing mode Press the top mode button to select the Tidal Assist mode The Tidal Assist mode light will blink 3 Select the flow setting Use the buttons to select the prescribed flow ra...

Страница 16: ...lect the flow setting Use the buttons to select the prescribed oxygen flow rate 1 5 The green light for the selected flow rate will blink Each press on the buttons decreases or increases the flow rate setting by 1 unit Using Constant Flow Mode Constant Mode provides a steady flow of oxygen all the time Before turning on the device make sure that the supply tubing and the nasal pillow interface are...

Страница 17: ... the valve is open Note Use the bypass valve only if the device does not operate Standard TAV modes will not work properly when the bypass valve is opened If your TAV device stops working e g because of a dead battery the Bypass Valve may be used to deliver a constant flow of oxygen at about 2 lpm Do not use the Bypass Valve for normal operation ...

Страница 18: ...sal pillow interface fit 3 Check tubing for kinks and leaks 4 Check that all tubing connections are securely attached 5 Turn the device OFF and then back ON 6 If the problem persists turn off the device and contact customer support for assistance Use Bypass Valve if needed What to do 1 Check tubing for kinks and leaks 2 Check that all tubing connections are securely attached 3 Check gas source 4 I...

Страница 19: ...ge e g tears loose parts etc Replace the nasal pillow interface with a new one if you see any damage Periodically or as needed Clean your nasal pillow interface using warm water and liquid dish soap º Submerge the nasal pillow interface in a pan of lukewarm clean drinking water with a small amount of liquid dish soap e g Dawn Agitate and wipe gently to remove any debris º Rinse the pillows thoroug...

Страница 20: ... damage the nasal pillow interface and impair oxygen delivery General Troubleshooting Problem Possible Causes What To Do Device won t turn on No battery installed Install battery as shown on page 6 Battery installed backwards Check to make sure spring contact is against flat side of battery Remove and flip battery if necessary Power button was not held down long enough Hold power button down for o...

Страница 21: ... interface from device Turn device off and then back on After beep is heard reconnect the interface to the device Mouth breathing Make sure the user is inhaling through their nose Device triggers un expectedly Pulse and Tidal Assist modes Trigger threshold was not calculated correctly by system Disconnect interface from device Turn device off and then back on After beep is heard reconnect the inte...

Страница 22: ...ng The device detects that the flow output is not the same as the set flow 1 Check tubing for kinks and leaks 2 Check that all tubing connections are securely attached 3 Check gas source 4 If using a cylinder regulator wall source or air source make sure the Regulator Adaptor is used and is connected to a DISS connector 5 If using an oxygen concentrator ensure that the concentrator is TAV compatib...

Страница 23: ... has detected a fault preventing it from operating correctly 1 Make sure the Bypass Valve is closed fully pushed in 2 Turn the device OFF and then back ON 3 If problem persists stop using the system and contact Customer Support at 888 599 1105 4 If needed open the bypass by pulling out the stem page 14 The TAV will deliver a constant flow at 2 LPM ...

Страница 24: ...0 feet Enclosure Rating IP22 ingress protection IP22 means that the TAV device is designed to not allow touching of any hazardous parts of the device for objects 12 5mm e g fingers In addition the TAV enclosure provides protection against dripping water up to an angle of 15 degrees Alarm Volume 65 80 dBA measured at 1 m Weight and Dimensions Approximately 3 8 ounces with battery 108 grams Approxim...

Страница 25: ...ed O2 Volume Breath ml Maximum breath rate BPM Accuracy 1 10 40 15 2 20 40 3 30 40 4 40 40 5 50 40 Tidal Assist Mode Setting Delivered O2 Volume Breath ml Maximum breath rate BPM Accuracy 1 50 40 10 2 100 40 3 150 33 4 200 25 5 250 20 Constant Mode 1 5 LPM 15 ...

Страница 26: ... 5 2 4 5 3 9 3 5 3 1 2 8 2 6 2 4 2 2 2 1 5 4 2 3 6 3 1 2 8 2 5 2 3 2 1 2 0 1 8 1 7 Table 2 Cylinder Size E M 24 616 liters when full Breaths per Minute 12 14 16 18 20 22 24 26 28 30 Flow Setting Tank duration in hours 1 85 6 73 3 64 2 57 0 51 3 46 7 42 8 39 5 36 7 34 2 2 42 8 36 7 32 1 28 5 25 7 23 3 21 4 19 7 18 3 17 1 3 28 5 24 4 21 4 19 0 17 1 15 6 14 3 13 2 12 2 11 4 4 21 4 18 3 16 0 14 3 12 8...

Страница 27: ...8 0 7 0 6 0 6 0 6 0 5 0 5 0 5 NA 5 0 8 0 7 0 6 0 6 0 5 NA NA NA NA NA NA Table 2 Cylinder Size E M 24 616 liters when full Breaths per Minute 12 14 16 18 20 21 22 23 24 25 30 Flow Setting Tank duration in hours 1 17 1 14 7 12 8 11 4 10 3 9 8 9 3 8 9 8 6 8 2 6 8 2 8 6 7 3 6 4 5 7 5 1 4 9 4 7 4 5 4 3 0 4 3 4 3 5 7 4 9 4 3 3 8 3 4 3 3 3 1 3 0 2 9 2 7 2 3 4 4 3 3 7 3 2 2 9 2 6 2 4 2 3 2 2 2 1 2 1 NA 5...

Страница 28: ...racy Table 1 Cylinder Size B M 6 150 liters when full Flow Setting Tank duration in hours 1 2 5 2 1 3 3 0 8 4 0 6 5 0 5 Table 2 Cylinder Size E M 24 616 liters when full Flow Setting Tank duration in hours 1 10 3 2 5 1 3 3 4 4 2 6 5 2 1 Example 1 M6 tank flow setting 3 Using table 1 find flow setting of 3 The approximate tank duration at 3 lpm 0 8 hours Exampe 2 E tank flow setting 2 Using table 2...

Страница 29: ... button Back of device label Product contains electronic waste and must be disposed of accordingly Cover of Instructions for Use Product is non sterile Back of device label Product provides Type BF electrical patient isolation Back of device label Manufactured by Cover of Instruc tions for Use Back of device label Prescription use only Back of device label Not for use in MRI environment Silence Al...

Страница 30: ...supply network that supplies buildings used for domestic purposes Harmonic Emissions IEC 61000 3 2 Not Applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not Applicable Guidance and manufacturer s declaration electromagnetic immunity The TAV system is intended for use in the electromagnetic environment specified below The user of this system should assure that it is used in such an en...

Страница 31: ...3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the A C mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity The TAV system is intended for use in the electromagnetic environment specified below The user of this system shou...

Страница 32: ... with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM r...

Страница 33: ...Separation distance according to frequency of transmitter meters 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 Not applicable 0 018 0 035 0 1 Not applicable 0 057 0 11 1 Not applicable 0 18 0 35 10 Not applicable 0 57 1 1 100 Not applicable 1 8 3 5 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated usin...

Страница 34: ...000 977 1 1 1 2000 942 2 1 3 4000 874 5 3 6 6000 810 7 4 10 8000 751 10 6 13 10000 695 12 7 16 12000 643 15 8 20 14000 595 18 10 23 Examples 1 The flow setting on your TAV device is set at 3 lpm and the altitude is 4 000 ft Find 4 000 feet on the table º Pulse Mode change 5 Volumes will be about 5 lower compared with sea level º Tidal Assist Mode change 3 Volumes will be about 3 lower compared wit...

Страница 35: ... 27 EMC Information 27 30 Enclosure Rating 21 Glossary 1 Icons 26 Intended Use 2 Introduction 1 Low Battery Indicator 15 Maintenance 16 Malfunction 17 Model Number 21 Nasal Pillow Interface putting on 9 Operating Temperature 21 Oxygen Cylinder Duration Pulse Mode 23 Tidal Assist Mode 24 Constant Mode 25 Oxygen Delivery Performance Pulse Mode 22 Tidal Assist Mode 22 Constant Mode 22 Pulse Mode 1 11...

Страница 36: ...33 Inogen Inc 326 Bollay Drive Goleta CA 93117 Phone 888 599 1105 Email info tidalassist com Web www tidalassist com 2020 Inogen All rights Reserved PN 96 09781 00 01 D ONLY ...

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