AutoMedx SAVe II Operation Manual
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AutoMedx SAVe II Operation Manual

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  • Page 1 SAVe II Operation Manual...

  • Page 3: Preamble

    Document Version M40100 Rev 4.0 (07/16); Firmware Version R1.0.4 If more than 1 year has elapsed since the date above contact AutoMedx to determine if there have been any updates to the product or to this manual. SAVe II OPERATION MANUAL  Page 3...

  • Page 4: Notice To Operators

    The detailed information and instructions contained within this Operation Manual are designed to ensure the safe and effective setup, use, and field maintenance of the SAVe II™. The SAVe II must be setup, operated, maintained and repaired in accordance with the instructions provided in this manual, accompanying labels and inserts.

  • Page 5: Table Of Contents

    B – R ............. 48 PPENDIX EGULATORY LASSIFICATION IMITED ARRANTY C – P ..................... 51 PPENDIX RINCIPLES PERATION D - R ....................53 PPENDIX RDER NFORMATION E – S ..................... 54 PPENDIX OFTWARE ELEASE HISTORY SAVe II OPERATION MANUAL  Page 5...

  • Page 6: Safety Information

    Safety Information Operators MUST read and understand the following information about Warning and Caution and statements BEFORE operating the SAVe II™. General warnings and cautions are listed below. Specific warnings appear throughout the manual where pertinent. WARNING “WARNING” statements alert the reader to potentially hazardous situations, which, if not avoided, could result in death or serious injury.

  • Page 7: General Warning Statements

    General Warning Statements Restricted Use - The SAVe II is a restricted device that must be used according to its intended use by properly trained and qualified personnel under the direction of a physician and in accordance with applicable laws and regulations.

  • Page 8: Caution Statements

    SAVe II and its accessories are shipped clean, but not sterile. Liquids – To avoid inadvertent damage, do not pour or spray liquids directly on the SAVe II. If liquid cleaners are used, spray on a lint free cloth, then use the cloth to clean the SAVe II and its accessories.

  • Page 9: Use Of Symbols

    UMBER ATEX CE M ATCH ARKED RODUCT ATTERY EVEL OT USE IF PACKAGE IS DAMAGED HARGE TERILE OMPRESSION RAGILE ANDLE WITH ECREASE ARAMETER EMPERATURE IMIT NCREASE ARAMETER IP24 NCLOSURE ROTECTION ATING ATIENT EIGHT SAVe II OPERATION MANUAL  Page 9...

  • Page 10: Introduction

    INTRODUCTION Device Overview The SAVe II is designed to be used in lieu of a Bag Valve Mask (BVM) in the pre-hospital environment or during inter-and intra-hospital transport. It is meant to remove the guesswork and reduce the operator error associated with BVMs and overly sophisticated transport ventilators.

  • Page 11: Indications For Use

    WARNING: The performance of the SAVe II may be materially affected if it is used outside of the specified NORMAL OPERATING CONDITIONS. If at the discretion of the medical director, the device is used outside of the specified NORMAL OPERATING CONDITIONS, but within specified EXTREME OPERATING CONDITIONS, the Operator must practice extra patient vigilance.

  • Page 12: Features

    Second, the SAVe II, unlike a BVM, frees up the responder to address other injuries, attend to other patients or further assist in the evacuation. Third, the SAVe II will provide up to 10 hours of ventilation on a full charge (time varies depending on settings). It is impractical to expect a medic to manually ventilate a patient for that duration with a BVM.

  • Page 13: Device Description

    Secondary indicators, displays and controls generally used to monitor and LOWER UI PANEL fine tune ventilator parameters. (Black) ALARM PANEL (Black – Bottom Alerts operator to potential issues with operation of device. of UI Panel) SAVe II OPERATION MANUAL  Page 13...

  • Page 14: Description Of Controls, Indicators And Displays

    Silences an active audible alarm for 120 seconds. New alarm will override. If 15 Mute alarm condition still presents after 120 seconds the audible alarm will resume. Feature available in devices programmed with firmware release R1.0.4 or later SAVe II OPERATION MANUAL  Page 14...

  • Page 15: Device Labeling

    Device Labeling RONT ANEL ABEL NTERFACE FIGURE 2: USER INTERFACE SAVe II OPERATION MANUAL  Page 15...
  • Page 16 ANEL ABELS The SAVe II back panel has two labels. These labels are intended as a reference to users who have read this manual. The back panel device labels include information concerning:  Basic setup instructions  Tidal volume reference table for advanced users ...

  • Page 17: Alarm Dashboard

    Indicates a patient inspiratory effort has been detected BREATH ASSIST Page 41 and a patient triggered breath has been delivered. Refer to information on page 37 for instructions detailing how to respond to alarms. SAVe II OPERATION MANUAL  Page 17...

  • Page 18: Device Disposables & Accessories

    Mask E11000 and patient. Mask Inflation E10996 Used to re-inflate mask if necessary. Syringe Items provided for convenience of user and may not be included in all kits. Please check with your distributor. SAVe II OPERATION MANUAL  Page 18...

  • Page 19: Prepare For Use

    Note: An airway is required for use but may not be included with kit. Operators must identify an airway appropriate for the situation and have it ready for use. The SAVe II should always be packaged with an airway that is appropriate based on the training of the provider and needs of the patient. Consult your medical director.
  • Page 20 AutoMedx recommends replacing the debris filter after each patient use due to the austere environments in which the SAVe II is often used. The debris filter may require replacement less often if the device is not being used in particularly dirty or dusty environments.
  • Page 21 The SAVe II is primarily powered by an internal lithium-ion battery. The battery is re-charged by connecting the SAVe II to external power (100 – 240 VAC, 50 – 60 Hz) via the AC POWER SUPPLY (P/N: E52240). When the SAVe II is connected to external power by the AC Power Supply it can simultaneously run and charge the internal lithium-ion battery.

  • Page 22: Using The Save Ii

    Demand Valve is meant to allow a patient to draw in ambient air if they begin to breath spontaneously. CONNECT THE SAVe II PATIENT BREATHING CIRCUIT BY: Locate an unused SAVE II PATIENT BREATHING CIRCUIT (P/N: M40105) in its original packaging. Remove Patient Breathing Circuit from packaging.
  • Page 23 Step 2: Verify Proper Operation Verify basic functionality and safety of the SAVe II prior to each mission or immediately prior to use. Test Procedure...
  • Page 24 Circuit can be connected to a variety of airways using the standard 22mm O.D. / 15mm I.D. patient connection port. The SAVe II should always be packaged with an airway (Mask, King-LT, ET Tube, etc.) that is appropriate based on the training of the provider and needs of the patient. Read and follow separate airway Instructions for Use.
  • Page 25 Refer to the specifications on page 47 for the tolerances of each parameter. There is a look up table on the back of the device to help provider make further adjustments. This label is also included on page 16 of this manual. SAVe II OPERATION MANUAL  Page 25...
  • Page 26 The Respiratory Rate controls the number of breaths delivered to the patient in a minute. When the RR is set to 0 and confirmed, this will place the SAVe II into MASK CPR Mode. While in this mode, the operator is in full control of when a breath is delivered to the patient. The operator controls the respiratory rate by pressing the Manual Trigger button.
  • Page 27 RR & TV Combinations The SAVe II supports minute volumes of up to 8 LPM at an I:E ratio of 1:2. The cells marked with an “X” are combinations that exceed the pump’s capabilities and therefore are not permitted. If an operator...
  • Page 28 The SAVe II has the internal capability to maintain a set Positive End Expiratory Pressure (PEEP). The device may take up to 1 minute to reach the desired PEEP level after a confirmed change. The SAVe II is designed to safely reach targeted PEEP value by slowly incrementing PEEP with each breath. The SAVe II may take up to a minute to reach targeted PEEP value.
  • Page 29 0 and 10 LPM. Given the max minute volume of the SAVe II is 8 LPM any additional oxygen flow would spill out of the reservoir tube into the ambient air. The Oxygen Reservoir will also dampen the noise produced by the ventilator.
  • Page 30 U shaped. Do not cut the fastener that holds the shape. In order to keep the SAVe II small the attenuator which mitigates the sound of the ventilator has been developed as an external reusable accessory rather than an internal component. It is not required for operation but can be used to significantly dampen the noise.

  • Page 31: Manually Triggered Breaths

    Manual Trigger Button to deliver the set Tidal Volume. To avoid stacking breaths, the Manual Trigger button is only active during the expiratory phase of the breath cycle. If the operator wants to only deliver manual breaths set the respiratory rate to zero. SAVe II OPERATION MANUAL  Page 31...
  • Page 32  Operators must press MANUAL TRIGGER control button for ventilator to deliver breath.  Increasing PIP LIMIT to above 20 cmH2O when using an airway other than a properly placed ET Tube may result in gastric insufflation. SAVe II OPERATION MANUAL  Page 32...

  • Page 33: Clearing Debris From Breathing Circuit

    Clearing Debris from Breathing Circuit The SAVe II Breathing Circuit is for a single patient use. If the patient aspirates during use and the circuit needs to be cleared of debris then follow steps below. CLEAR DEBRIS FROM BREATHING CIRCUIT BY: If an appropriate replacement circuit is available then replace active circuit with new circuit.

  • Page 34: Alarm Overview

    Alarm Overview The SAVe II has a number of alarms to alert the operator to potentially unsafe conditions. These alarms trigger by monitoring internal device parameters and airway pressures. The device will continue delivering breaths during most alarms; however, if it detects a condition that may cause direct harm to the patient by delivering another breath, the device will enter a safe mode and stop delivering breaths until the problem is resolved.

  • Page 35: Alarm Quick Reference Guide

    At 0% of capacity (running on Reserve Capacity) device will go into Low Battery Mode: Discontinue breaths Open Exhalation Valve Therapy control indicators are cleared All button presses (except mute and power) are disabled SAVe II OPERATION MANUAL  Page 35...
  • Page 36 “Breath Assist” alarm indicator Assist activates. Pressure > 2 cmH 2 O below set PEEP (Patient is Patient’s inspiratory effort spontaneously breathing) immediately triggers breath Deliver set TV at max pump flow rate Resume normal ventilation SAVe II OPERATION MANUAL  Page 36...

  • Page 37: Responding To Alarms

    POSSIBLE CAUSE WHAT TO DO Verify Breathing Circuit tubing connections between SAVe II control unit and airway.  Inadequately connected circuit tubing Verify mask or airway is tightly sealed to patient.
  • Page 38  Entering exhalation phase (cycling) when set pressure limit is reached WARNING:  If PIP limit is reached, the SAVe II will cut the inspiratory phase short and less than the stated TV will be delivered to patient.  Failure to respond to alarms can result in serious harm or death. Alarms should always be monitored and the operator should be prepared to ventilate with alternative method of ventilation.
  • Page 39 POSSIBLE CAUSE WHAT TO DO Connect device to an external power  The battery charge has been source using SAVe II AC Power Supply. depleted Prepare to ventilate by alternative  Battery has been stored for means if an external power source is not extended periods at high available.
  • Page 40 DEVICE ALARM The SAVe II software monitors multiple components to ensure they are operating within expected parameters. The Device Alarm is triggered when device is outside of specified temperature range OR a non- field correctible malfunction is detected. Device responds by: ...
  • Page 41 (spontaneous breathing) and triggered from ventilator if patient is able to breath assist breathe adequately.  CPR chest compressions have triggered If performing chest compressions, breath assist consider putting the ventilator into MASK CPR Mode. SAVe II OPERATION MANUAL  Page 41...

  • Page 42: Maintenance

    When a new battery is fully charged, the SAVe II will run for 10 hours when set to 500 ml and 10 BPM. BATTERY CHARGE RETENTION 21°C (70°F)
  • Page 43 Carrying Case ONTROL All SAVe II external surfaces should be cleaned before and after each patient use and as may be required. Wipe the exterior surfaces of SAVe II (including the inside of the port cover) with a clean, damp cloth.

  • Page 44: Replace Consumables

    Immersion – Under no circumstances should the SAVe II or its accessories be immersed in liquid. If the SAVe II becomes wet, the unit should be dried using a lint-free cloth immediately, or once the unit is no longer in use. If the SAVe II becomes immersed, discontinue use and return to appropriate service facility for inspection.

  • Page 45: Storage

    M40101) TORAGE The SAVe II should be stored as a complete kit in a state of readiness. AutoMedx recommends storing in the device’s hard case which is water, dust and sand proof. The SAVe II CARRYING CASE (P/N: F20055) is designed to protect the SAVe II and its accessories during transport, shipping overseas and storage especially in sandy, dusty or wet environments.

  • Page 46: Scheduled Maintenance

    CHEDULED AINTENANCE Automedx recommends performing service annually to verify the device continues to operate within specification. If the device is used in Extreme Environments or is exposed to dust, sand or water then maintenance should be performed more frequently. SAVe II OPERATION MANUAL  Page 46...

  • Page 47: Ppendix A- Specifications

    Delivered Tidal Volume may be materially affected by very low lung compliance (< 0.01 L/cmH Change to higher capacity battery was made in July 2016. The 5’9” preset will run approximately 10 hours with the new battery. SAVe II OPERATION MANUAL  Page 47...

  • Page 48: Appendixb - Regulatory Info /Classification / Limited Warranty

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The SAVe II Portable Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SAVe II Portable Ventilator should assure that it is used in such an environment. Compliance...
  • Page 49 The life of the battery, as noted above, is materially affected by many factors. As such, AutoMedx warrants to the Customer of the SAVe II that, if there is a defect in material or workmanship in the battery contained in the SAVe II and AutoMedx is notified of such defect within one (1) year of Customer’s original purchase, AutoMedx shall, in its sole and absolute discretion, repair or provide a...
  • Page 50 SAVe II product and or accessories. In any case, AutoMedx’s entire liability shall be limited to the amount actually paid for the purchase of the SAVe II product. Valid proof of purchase required. Disclaimer...

  • Page 51: Appendixc - Principles O F Operation

    PERATION The SAVe II is a completely self-contained, small, light-weight, r e c h a r g e a b l e battery powered device intended to provide controlled, positive pressure ventilation to a patient. It is a time cycled pressure limited volume targeted ventilator.
  • Page 52 During an exhalation phase, the reservoir tube will begin to fill with oxygen from the oxygen source. During the inhalation phase, the SAVe II will draw from the reservoir tube, thus pulling in oxygen to deliver to the patient. The amount of oxygen delivered to the patient is dependent on the flow rate of the oxygen source, which is set by the user.

  • Page 53: Appendixd - R E -Order Information

    Air Intake Debris Filter, Disposable, Single-Use, SAVe II F20053 AC Power Supply / Battery Charger, SAVe II E52240 / M40090 Power Cord, Type A (USA, Canada, Mexico, Japan), SAVe II E11021 Hard Case, SAVe II F20055 Oxygen Reservoir, SAVe II...

  • Page 54: Appendixe - Software Release History

     PIP & PEEP Display by hitting Confirm  Improve fault tolerance R1.0.4 July 13, 2016  Chirp when powering off  Improve recovery from low battery  Improve “Charge Level” reporting of Battery Charger LED SAVe II OPERATION MANUAL  Page 54...

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