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Page 32 

 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use    

Vapotherm Inc. 
100 Domain Drive 
Exeter, NH 03833
USA
Phone: 603-658-0011
Fax: 603-658-0181

RMS – UK Limited

28 Trinity Road

Nailsea, North Somerset BS48 4NU 

United Kingdom

Phone: +44-1275-85-88-91

Fax: +44-1275-85-88-91

0297

May be patented. www.vapotherm.com/patents

Summary of Contents for Oxygen Assist Module

Page 1: ...Oxygen Assist Module for use with Vapotherm Precision Flow Instructions for Use...

Page 2: ...ection 7 Patient Admission 12 Section 8 Alarm Setup 13 Section 9 SpO2 Setup 13 Section 10 O2 Setup 16 Section 11 System Shutdown 17 Section 12 Graphical Trend Display 17 Section 13 Logging of Variable...

Page 3: ...osed as an unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment De...

Page 4: ...y Therapy Equipment and Guidelines for Prevention of Nosocomial Pneumonia For more information see the Precision Flow Instructions for Use General Warnings Federal Law U S restricts the use of this de...

Page 5: ...rous oxide To ensure safety avoid stacking multiple devices or placing anything on the device during operation To protect against injury follow the directions below Avoid placing the device on surface...

Page 6: ...lly calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin COHb and methemoglobin MetHb Do not adjust repair open disassemble or modify the Oxygen Assist Module or accessories...

Page 7: ...her use Injury to personnel could occur Disposal of product Comply with local laws in the disposal of the device and or its accessories To minimize radio interference other electrical equipment that e...

Page 8: ...sis of real time measurements and trending to choose the appropriate O2 delivery The use of smart averaging and hysteresis algorithms by the Masimo SET SpO2 monitor protects the system from artifacts...

Page 9: ...ssist Module and provides 12VDC to the Oxygen Assist Module Contact Vapotherm if you believe your power adapter to not be functional or you need a replacement Only use power adapter as provided by Vap...

Page 10: ...w s interface port 6 Plug the Oxygen Assist Module Power Supply into the Oxygen Assist Module and into an electrical outlet marked Hospital Grade or Hospital Only NOTE Ensure proper orientation on Pow...

Page 11: ...oxygen Using Menus To call up a menu press the desired menu tab Alternately parameter boxes will redirect to the associated menu Notes Unless otherwise stated the change to settings takes effect when...

Page 12: ...tely place the Oxygen Assist Module in Manual O2 Mode A manual change in O2 on the Precision Flow with 120 90 60 30 15 5 seconds selected will suppress Auto Mode O2 titration for that period of time b...

Page 13: ...rm is generated stating No Sensor Connected Alarm messages cycle in the message area For a list of alarm messages and required action please see the section Alarm and Status Messages For alarm indicat...

Page 14: ...ors may cause incorrect SpO2 readings Before using the sensor carefully read the sensor documentation including all warnings cautions and instructions The accuracy of pulse oximetry readings can be ad...

Page 15: ...es Signal IQ values of less than 0 3 The SpO2 display range is from 1 100 A value of indicates that no measurement is available The pulse rate display range is from 1 240 bpm A value of indicates that...

Page 16: ...trol knob Note See description of Fallback O2 Functionality on the following page for more information 3 Insert Oxygen Assist Module Time Card and Press Start Case When the patient is stable press the...

Page 17: ...s If the Oxygen Assist Module has exited the Auto mode check the patient sensor placement connections and settings When clinically indicated place the Oxygen Assist Module back into Auto mode in the P...

Page 18: ...ng and disinfecting instructions for the SpO2 sensor and patient cable see the instructions provided with the sensor Section 14 Cleaning and Disinfecting Section 17 Referenced Documentation Precision...

Page 19: ...Clinical patient condition Check patient Sensor not connected Check sensor and cable connections Sensor off patient Check sensor application Sensor or cables damaged Check sensor and cables Replace i...

Page 20: ...yperbaric cond Storage and Shipping Ambient Temperature 10 50 C Ambient Relative Humidity 20 90 RH Contact with Patient Indirectly via SpO2 sensor and Precision Flow O2 cannula Liquid Ingress Protecti...

Page 21: ...trical Equipment Part 1 6 General requirements for basic safety and essential performance Collateral Standard Usability IEC 60601 1 8 2006 Second Edition Am 1 2012 for use in conjunction with IEC 6060...

Page 22: ...female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion bet...

Page 23: ...Case Check SpO2 Defective Cable Replace cable enter MANUAL Mode or End Case Check SpO2 Defective Sensor Replace sensor enter MANUAL Mode or End Case Check SpO2 Incompatible Adhesive Sensor Replace se...

Page 24: ...Demo Mode Reconnect sensor with good signal Check SpO2 Interference Detected Reconnect sensor with good signal Check SpO2 Low Perfusion Index Reconnect sensor with good signal Check SpO2 Low Signal I...

Page 25: ...target and sets the FiO2 delivery rate accordingly The algorithm makes near immediate adjustments within 10 seconds to changes in SpO2 readings learns from past changes and anticipates short term cha...

Page 26: ...s declaration electromagnetic emissions The Oxygen Assist Module is intended for use in the electromagnetic environment specified below The customer or the user of the Oxygen Assist Module should ass...

Page 27: ...y should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5 1 and 2 kV Line s to Ground 1 kV line s to Line s 0 5 1 and 2 kV 1 kV Mains power quality should be that of a t...

Page 28: ...paration distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interferenc...

Page 29: ...ed maximum output power of transmitter W Separation distance according to frequency of transmitter m 50 kHz to 80 MHz outside ISM bands d 1 2 P 150 kHz to 80 MHz in ISM bands d 1 2 P 800 MHz to 2 5 GH...

Page 30: ...Page 30 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use This Page Intentionally Blank...

Page 31: ...3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 31 This Page Intentionally Blank...

Page 32: ...for Use Vapotherm Inc 100 Domain Drive Exeter NH 03833 USA Phone 603 658 0011 Fax 603 658 0181 RMS UK Limited 28 Trinity Road Nailsea North Somerset BS48 4NU United Kingdom Phone 44 1275 85 88 91 Fax...

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