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3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use

Page 31

REPLACE OXYGEN

SENSOR

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Содержание Oxygen Assist Module

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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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