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AutoMedx SAVe II+ Instructions For Use Manual

Ventilator operator’s guide
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SAVe II+ Ventilator Operator's
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I​
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N STRUCTION​
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  • Page 1 SAVe II+ Ventilator Operator’s Guide ​ I​ U​ N STRUCTION​ F OR​...
  • Page 2 U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners of this ventilator are required to register the device and to inform AutoMedx if the device is sold or given to another organization or destroyed. This allows AutoMedx to notify you of safety updates, a recall or software updates.

  • Page 3: Notice To Operators

    Please contact AutoMedx if the instructions in this manual conflict with your protocols. Federal law (U.S.A) restricts this device to sale by or on the order of a licensed medical practitioner.

  • Page 4: Table Of Contents

    ​ T​ C​ A BLE​ O F​ O NTENTS Preamble Notice to Operators FDA Tracking Requirements Safety Information General Warning Statements Caution Statements Use of Symbols INTRODUCTION Device Overview Indications for Use Contra-Indications Use Environment Training Requirements Features Risks & Benefits DEVICE DESCRIPTION User Interface Description of Controls, Indicators and Displays...
  • Page 5 A​ D - R​ - O​ I​ P PENDIX​ E ​ R DER​ N FORMATION ​ A​ E – S​ R​ P PENDIX​ O FTWARE​ E LEASE​ H ISTORY SAVe II+ OPERATION MANUAL ​ > ​ P age 5...

  • Page 6: Safety Information

    Safety Information Operators ​ M UST ​ r ead and understand the following information about Warning and Caution and statements ​ B EFORE ​ o perating the SAVe II+™. General warnings and cautions are listed below. Specific warnings appear throughout the manual where pertinent.

  • Page 7: General Warning Statements

    Discontinue use and immediately contact an authorized service technician or AutoMedx. If equipment is damaged or behaves in a way that is inconsistent with normal operation, stop...
  • Page 8 Personal Injury and Electrical Shock​ - To avoid electric shock hazard, do not open the enclosure casing and do not use batteries, AC adapters, cables, or external power supplies with visible signs of damage. Only use power supplies approved by AutoMedx. Refer to http://automedx.com/accessories​...

  • Page 9: Caution Statements

    IEC 60601-1-2. Service Personnel Qualifications ​ - All servicing and repair of the SAVe II+ must be performed by a service technician qualified by AutoMedx. To request a SAVe II+ SERVICE MANUAL...
  • Page 10 SAVe II+ OPERATION MANUAL ​ > ​ P age 10...
  • Page 11 Symbols Glossary Symb Title & Usage Symbol Title & Usage ’ ​ R​ O​ M​ E AD​ P ERATOR​ S ​ A NUAL O​ / O​ P​ B​ N ​ F F​ O WER​ U TTON C​ A UTION C​ I​...

  • Page 12: Introduction

    - S​ C​ R​ NON​ T ERILE O MPRESSION​ A TE ​ F​ , H​ C​ D​ P​ R AGILE​ A NDLE​ W ITH​ A RE E CREASE​ A RAMETER T​ L​ I​ P​ E MPERATURE​ I MIT N CREASE​ A RAMETER IP24 E​...
  • Page 13 The SAVe II+ uses a battery-powered compressor to deliver air to a patient for up to 8.5 hours on a single charge. To support use in austere environments, where compressed oxygen is unavailable or ill advised, the device does not require compressed oxygen. However, FiO​...

  • Page 14: Indications For Use

    Indications for Use The SAVe II+ series are intended to provide ventilatory support for adults during CPR or when positive-pressure ventilation (PPV) is required to manage acute respiratory failure (ARF) or other situations where mechanical ventilation is needed. The SAVe II+ series are appropriate for adults that weigh at least 45 kg (99lb).

  • Page 15: Training Requirements

    specified extreme operating environments. This may result in ventilator failure and/or harm to the patient. Training Requirements: The device is intended for use by and under the supervision of trained healthcare professionals, e.g., doctors, nurses, emergency medical technicians, respiratory therapists, paramedics and those certified to perform CPR. All operators regardless of experience or training must be familiar with the contents of this manual and be prepared to provide primary response to a respiratory emergency.

  • Page 16: Device Description

    Unlike pneumatic resuscitators, the SAVe II+ does not require compressed air to operate, however it will accept low-pressure supplemental oxygen when a higher FiO2 is needed. If in a combat zone, relying on high-pressure oxygen tanks poses a fire and explosion hazard.
  • Page 17 button (see above) is pressed when all of the parameter displays are solid then measured pressures (PIP & PEEP) will be displayed for 3 seconds. SECTION DESCRIPTION UPPER UI PANEL Primary indicators, displays and controls generally used (Gray) during initial setup. LOWER UI PANE Secondary indicators, displays and controls generally used (Black)

  • Page 18: Description Of Controls, Indicators And Displays

    Description of Controls, Indicators and Displays REFERENCE & NAME DESCRIPTION Control used to turn the device on and off. Press for 1 second ​ to turn on. Hold for 3 seconds to turn off.​ T he high priority POWER ON/OFF audible alarm indicator will activate 1 second prior to shut down.

  • Page 19: Feature Available In Devices Programmed With Firmware Release R1.0.4 Or Later

    1 ​ Feature available in devices programmed with firmware release R1.0.4 or later SAVe II+ OPERATION MANUAL ​ > ​ P age 19...

  • Page 20: Device Labeling

    Device Labeling F​ P​ L​ / U​ I​ R ONT​ A NEL​ A BEL​ S ER​ N TERFACE FIGURE 2: USER INTERFACE SAVe II+ OPERATION MANUAL ​ > ​ P age 20...
  • Page 21 B​ P​ L​ A CK​ A NEL​ A BELS The SAVe II back panel has two labels. These labels are intended as a reference to users who have read this manual and the Quick Start Guide. The back panel device labels include information concerning: Basic setup instructions Tidal volume reference table...

  • Page 22: Alarm Dashboard

    Side Panel Labels Alarm Dashboard The alarm dashboard is located at the bottom of the user interface. Alarm codes will illuminate in red to alert the operator of various conditions: Warning: ​ N ever cover or obstruct the alarm panel. The operator must have a clear view of the panel at all times when the device is connected to the patient, especially in noisy environments where caregiver may not hear alarms.

  • Page 23: Device Disposables & Accessories

    Alarm Code Device The device is outside its temperature range or a software, mechanical or electrical issue has been detected. DISCONNE The minimum pressure threshold has not been reached during an inhalation. Most likely caused by a disconnection of the breathing circuit tubing or patient airway.
  • Page 24 power. Power Cable (Type Connects the AC power supply to external E11021 power. Protects the system during transport and Hard Carrying Case F20065 storage. Head Harness​ E11001 Assists user in securing mask to patient. Basic non-invasive interface between Mask​ E11000 breathing circuit and patient.

  • Page 25: Prepare For Use

    Consult your medical director. Only use accessories approved by AutoMedx for use with the SAVe II+. To verify if an airway is approved for use with the SAVe II+, visit http://automedx.com/accessories​...
  • Page 26 The above list describes the configuration of the Standard,70110H-US, Kit. The specifics of your configuration may vary based on the country or region of use and the specific requirements of your organization. Step 3A: Verify Debris Filter Installation The DEBRIS FILTER (P/N: F20053) is intended to protect the internal components of the SAVe II+ system from dust, dirt and other particles.
  • Page 27 SAVe II+ OPERATION MANUAL ​ > ​ P age 27...
  • Page 28 Then reconnect the circuit with the HME filter in place. AutoMedx recommends the following procedure when the HME filter needs to be changed if the patient requires PEEP. This procedure is intended to limit the amount of PEEP lost by the patient when the HME filter needs to be exchanged, removed, or added.
  • Page 29 v. The DISCONNECT alarm will trigger when delivering the manual breath, this is ok. 6. If the HIGH PEEP alarm is not flashing, open the patient airway per healthcare center protocol. 7. Administer one manual breath to provide immediate respiration. 8.
  • Page 30 The battery should only be replaced by qualified biomedical equipment technicians. Only use AC power supplies from AutoMedx or its authorized distributors. The SAVe II+ AC power supply has been carefully selected to meet all required standards for a medical device as well as for safely charging the SAVe II+ lithium ion battery.

  • Page 31: Using The Save Ii

    USING THE SAVe II+ Setup for Use ✔ Manual Trigger Breaths ✔ Clear breathing circuit of Debris ✔ Alarms ✔ SAVe II+ OPERATION MANUAL ​ > ​ P age 31...

  • Page 32: Setup For Use

    CONNECT THE SAVe II+ PATIENT BREATHING CIRCUIT BY: 1 Locate an unused SAVe II+ patient breathing circuit (P/N: F20066) in its original packaging. See​ ​ h ttp://automedx.com/ ​ for compatible patient breathing circuits. 2 Remove patient breathing circuit from packaging.
  • Page 33 The demand valve’s two internal one-way valves must be oriented in the direction of airflow. Failure to properly connect the breathing circuit and accessories may materially impact device performance. Only use breathing circuits expressly approved by AutoMedx for use with the SAVe II+ Ventilator. See ​ w ww.automedx.com​ for compatible breathing circuits.
  • Page 34 WARNING: ​ If the device fails the checkout, do not use and have it serviced immediately. SAVe II+ OPERATION MANUAL ​ > ​ P age 34...
  • Page 35 Step 3: Select Adult Patient Height HEIGHT PRESETS allow minimally trained providers to deliver a more targeted and consistent therapy than can be achieved with a BVM and allows trained providers to quickly provide ventilation without consultation of external resources. The provider simply selects the patient's height.
  • Page 36 Table 1. Adult HEIGHT PRESET Values HEIGHT HEIGHT TV​ Minute PEEP (FT’ IN”) (cm) (BPM) (ml) Volume (cmH​ (cmH​ 2 ​ 2 ​ (LPM) 4’ 3” 4’ 6” 4’ 9” 5’ 0” 5’ 3” 5’ 6” 5’ 9” 6’ 0” 6’...
  • Page 37 to a flow-regulated oxygen tank, a low-flow wall source or an oxygen concentrator capable of delivering between 0 and 12 LPM. Given the max minute ventilation of the SAVe II+ is 12 LPM any additional oxygen flow would spill out of the reservoir tube into the ambient air. The Extendable oxygen reservoir tube will also dampen the noise produced by the ventilator.
  • Page 38 user modify the low pressure O2 line. In addition, the line must be attached without the use of lubricants. Take required precautions when using oxygen. Do not use in explosive atmospheres or near open flame. Do not use flow rates greater than 12 LPM. The desired FIO2 is achieved by regulating the amount of O2​...
  • Page 39 airway. Attach patient breathing circuit to airway by connecting patient connection port to airway. Verify the rise and fall of the chest and breath sounds as well as the absence of alarms. FIGURE 6: PATIENT BREATHING CIRCUIT WARNING: ​ R efer to the Instruction for Use of the airway used for further instruction SAVe II+ OPERATION MANUAL ​...
  • Page 40 Step 6A – Refine Parameters While the HEIGHT PRESETS enable providers the ability to deliver a more targeted and consistent therapy than is possible with BVMs, a user can adjust the settings as necessary if clinically indicated., OPERATOR ACTION EXPECTED DEVICE RESPONSE Setup based on patient height See previous section (step 3) adjusted settings blink until the...
  • Page 41 >12 LPMIf +/- controls appear to not work, it is likely that the operator has attempted to select a RR/TV combination that is not supported. AutoMedx recommends that the operators experiment with this during training so that it does not come as a surprise during actual use.
  • Page 42 SAVe II+ OPERATION MANUAL ​ > ​ P age 42...
  • Page 43 Peak Inspiratory Pressure (PIP) The PIP limit controls the maximum acceptable pressure during the Inspiratory Phase before the pump shuts off and the PIP REACHED alarm activates. When the PIP limit is reached, the pump will cut-off to prevent over inflation and the unit will enter the exhalation phase.
  • Page 44 SAVe II+ OPERATION MANUAL ​ > ​ P age 44...
  • Page 45 Step 6B: Connect Noise Attenuator (Optional) The reusable ATTENUATOR (P/N: M41112) is a U shaped tube designed to mitigate the noise of the device. The attenuator is connected to the air intake port as shown in Figure 8. The attenuator is meant to be 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.

  • Page 46: Manually Triggered Breaths

    WARNING: ​ I n particularly sandy or dusty conditions use the air intake port cap instead of the attenuator. Step 7: Monitor Patient and Respond to Alarms Monitor the patient and verify adequate chest rise and breath sounds. Refer to information on page 37 for information on how to respond to alarms.
  • Page 47 Operator Action Expected Device Response Set TIDAL VOLUME TV indicator blinks MANUAL TRIGGER and RR indicators blink Decrease RESPIRATORY RATE PEEP disabled (set to zero) to zero (0) PIP defaults to 20 cmH​ 2 ​ TV, RR and MANUAL TRIGGER lights stop blinking Press CONFIRM Compression rate light (heart icon) flashes at...

  • Page 48: 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 the active circuit with a new circuit.

  • Page 49: 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 50 Beep ​ , Pause 200ms, ​ B eep ​ , Pause 200ms…. Breath Assist Medium Battery <10% capacity Repeats every 7.5 seconds Beep ​ , Pause 200ms… Battery <15% capacity Repeats every 20 seconds   SAVe II+ OPERATION MANUAL ​ > ​ P age 50...
  • Page 51   R​ ​ A​ E SPONDING​ T O​ L ARMS   DISCONNECT ALARM The DISCONNECT alarm indicates the minimum pressure threshold has not been reached during the inspiratory phase​ o f the ventilator. The ventilator will continue to ​ operate and alarm until the condition is resolved. Triggered when airway pressure is <1cmH​...
  • Page 52 flow rate is > 14Lpm and end inspiratory pressure is < 5cmH​ 2​   PIP REACHED ALARM The PIP REACHED alarm will activate if the pressure measured at the patient airway exceeds the PIP Limit setting. When this alarm occurs, any inspiration in progress is terminated and the Exhalation Valve i s opened.
  • Page 53 SAVe II+ OPERATION MANUAL ​ > ​ P age 53...
  • Page 54   BATTERY ALARM The BATTERY low-priority alarm activates when less than 15% of battery capacity remains. To resolve the alarm connect to an appropriate external power source. Device response: At 15% of capacity: o Low Priority audible indicator activates for 30 seconds o Last battery LED begins to flash At 8% of capacity: o Medium Priority audible indicator activates for 30 seconds...
  • Page 55 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: Activating DEVICE visual alarm indicator and high priority audible alarm indicator. Stops ventilating (cycling) Opens the exhaust valve to allow patient to spontaneously breath with minimal resistance...
  • Page 56 service. SAVe II+ OPERATION MANUAL ​ > ​ P age 56...
  • Page 57   MV HIGH ALARM Triggers when combination of TV/RR requires a minute ventilation (MV) that exceeds the device’s ability to maintain an I:E ratio of 1:2. The device will not permit the operator to select these TV/RR combinations. Refer to information on page 27. Device responds by: Activating MV HIGH visual alarm (no audio alarm) Not allowing the TV/RR combination...

  • Page 58: Maintenance

    1. If patient is not synchronizing with Patient inspiratory effort was ventilator, consider removing detected (spontaneous breathing) patient from ventilator if patient is and triggered breath assist able to breathe adequately. CPR chest compressions have 2. If performing chest compressions, triggered breath assist consider putting the ventilator into MANUAL/CPR Mode.
  • Page 59 charge/discharge cycles, previous storage conditions, depth of discharge and age of battery. 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 21°C (70°F) 45°C RETENTION (113°F) 1 Month...
  • Page 60 All batteries degrade over time. The below chart shows you how much of the battery’s potential can be recovered after a period of storage. If the battery will be stored at high temperatures store with 50% charge. Clipboard functionality has been disabled while a protected document is open. Please close this document to restore clipboard usage.
  • Page 61 Clean the port well and port cover prior to removing the debris filter. It is recommended the SAVe II+ be stored in its carrying case when not in use. SAVe II+ OPERATION MANUAL ​ > ​ P age 61...
  • Page 62 ● Patient breathing circuit ● Debris filter ● Mask ● Heat and moisture exchanger (HME or HME-F) ● Reordering information is available in Appendix D or at http://www.automedx.com ● SAVe II+ OPERATION MANUAL ​ > ​ P age 62...

  • Page 63: S T Orage

    S​ T ORAGE 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: F20065) is designed to protect the SAVe II+ and its accessories during transport, shipping overseas and storage especially in sandy, dusty or wet environments.

  • Page 64: S C Heduled M A Intenance

    C HEDULED​ A INTENANCE 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.

  • Page 65: A P Pendix A- S P Ecifications

      A​ A– S​ P PENDIX​ P ECIFICATIONS​ Operating Modes: Continuous Mandatory Ventilation (CMV) tilat Control Primary Control: Time Secondary Control: Pressure Breath Target: Volume eter Flow Rate (LPM): Up to 36 Rate ​ 8 – 30 Breath Rate​ (BPM): Peak Inspiratory Pressure (PIP) Limit 10 - 60 Positive End Expiratory Pressure (PEEP)

  • Page 66: A P Pendixb - R E Gulatory

    Other Accessories See accessory labeling Device 3 years Battery 1 year Warranty: 1 ​ All specifications include a tolerance of ±10% of nominal value unless stated otherwise. Test conditions available upon Foot note request. 2 ​ Delivered Tidal Volume may be materially affected by very low lung compliance (< 0.01 L/cmH​ 2​...
  • Page 67 Voltage Fluctuations / Complies Flicker Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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. IEC60601 Test Complianc Electromagnetic Environment -...
  • Page 68 Voltage dips, Complies Mains power quality should be that of >95% dip short interrupts a typical commercial or hospital 0.5 cycle and voltage environment. If the user of the SAVe 60% dip variations on II+ requires continued operation during 5 cycles power supply power mains interruptions, it is 70% dip...

  • Page 69: I N Fo / L I Mited W A Rranty

    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...
  • Page 70 CONTRACT, TORT, OR ANY OTHER LEGAL THEORY. Limited Liability To the maximum extent permitted by applicable law, in no event shall AutoMedx or its Suppliers be liable for any special, incidental, indirect, physical or consequential damages whatsoever arising out of the use or inability to use the SAVe II+ product and or accessories.

  • Page 71: A P Pendixc - P R Incipleso

    A​ C – P​ O​ O​ P PENDIX​ R INCIPLES​ F ​ P ERATION The SAVe II+ is a completely self-contained, small, light-weight, rechargeable battery powered device intended to provide controlled, positive pressure ventilation to a patient. It is a time-cycled pressure-limited volume-targeted ventilator. The SAVe II+ will monitor the patient’s airway pressure and provide alarms for key events such as but not limited to: disconnect, high inspiratory pressure, and device malfunction.
  • Page 72 compression rate by the American Heart Association for CPR. In this mode the PIP Limit will automatically be set to 20 cmH​ O (as opposed to 30 cmH​ O in “Ventilation” mode), as 2​ 2​ in the event that a mask is used as the airway of choice, this setting will decrease the likelihood of gastric insufflation.
  • Page 73 A​ D - R​ - O​ I​ E ​ P PENDIX​ R DER​ N FORMATION Item Part Number Package SAVe II+ Kits​ 1​ SAVe II+ Kit with Hard Case, English, Type A Plug (USA) 70110H-US SAVe II+ Kit with Hard Case, Metric, English, Type A Plug 70110H-CA (Canada/Mexico) SAVe II+ Kit with Hard Case, Metric, English, Type C Plug (Europe)
  • Page 74 4 ​ Mask labelling indicates alternative manufacturer part number 1055 5 ​ The mask and syringe are only resupplied as a set 6 ​ Item provided for convenience of user and may not be available in certain markets 7 ​ Includes battery and required replacement hardware 8 ​...

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