Table of Contents
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Table of Contents
Related Manuals for AutoMedx SAVe II+ Series
Summary of Contents for AutoMedx SAVe II+ Series
- Page 1 SAVe II+ Operator’s Manual NSTRUCTIONS FOR...
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Page 2: Notice To Operators
AutoMedx, LLC. Under the law, reproducing includes translating into another language or format. The SAVe II+™ logo and the names and marks associated with AutoMedx’s products are trademarks and/or service marks of AutoMedx, LLC and are registered and/or common law marks in the United States and various other countries. -
Page 3: Tracking Requirements
Your purchase and/or use of the Product signifies your agreement to these terms. 1) Ownership: All rights to the Software are owned by AutoMedx. The Software is licensed and not sold. AutoMedx reserves all rights not expressly granted by these terms. -
Page 4: Device Warnings
For more information refer to www.automedx.com/accessories PREVENTATIVE MAINTENANCE - Failure to follow preventative maintenance procedures could result in device malfunction. -
Page 5: Prior To & After Each Deployment
BATTERY - If you suspect the internal battery is damaged, take the unit out of service immediately. Contact AutoMedx for disposition instruction. DO NOT SHIP DAMAGED LITHIUM-ION BATTERIES. RISK OF INFECTION - A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. -
Page 6: Maintaining And Servicing
AINTAINING ERVICING 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 (P/N: M42147) and for qualification requirements visit www.automedx.com/service BATTERY REPLACEMENT & DISPOSAL - The SAVe II+ battery should only be replaced by qualified service personnel. - Page 7 . Only use power supplies approved by AutoMedx. Refer WITH VISIBLE SIGNS OF DAMAGE to http://automedx.com/accessories for more information. 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.
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Page 8: Table Of Contents
TABLE OF CONTENTS NOTICE TO OPERATORS ..................... 2 Document Version ............................2 Tracking Requirements ..........................3 Software/Firmware License ........................... 3 DEVICE WARNINGS ...................... 4 General ................................4 Prior To & After Each Deployment ........................ 5 Immediately Prior to Use ..........................5 During Use .............................. - Page 9 Step 5: Verify Disconnect Alarm ........................24 Step 6: Verify PIP Reached Alarm ......................24 Step 7: Connect Breathing Circuit to Airway ....................24 Supplemental Oxygen ..........................25 Noise Attenuator ............................26 REFINING VENTILATOR PARAMETERS ..............28 Respiratory Rate (RR) ..........................28 Tidal Volume (TV) ............................
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Page 10: Overview
Overview NDICATIONS FOR 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 (99 lbs). -
Page 11: Training Requirements
The most up to date information related to training for operating the SAVe II+ is available at www.automedx.com. & B... -
Page 12: Save Ii+ Ventilator
45 kg. SAVe II+ Ventilator The AutoMedx SAVe II+ ventilator is a small, extremely durable, portable mechanical ventilator designed to provide lifesaving mechanical ventilation in prehospital, aeromedical, field hospital and hospital settings. The SAVe II+ is not a full featured ICU ventilator, but can play a significant role in extending a hospital’s surge capabilities... -
Page 13: Front Panel
RONT ANEL Device controls, indicators and displays are located on the front panel of the device and are organized based on task for rapid setup and troubleshooting. The device is controlled using membrane buttons. Except for POWER ON/OFF, MUTE and MANUAL TRIGGER, control changes require confirmation to prevent inadvertent changes to device settings. - Page 14 Table 1: User Interface Overview Name Description POWER ON/OFF Control used to turn device On and Off. Press for 1 second to turn on. Hold for 3 seconds to turn off. The high priority audible alarm indicator will activate 1 second prior to shut down.
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Page 15: Alarm Dashboard
LARM ASHBOARD The alarm dashboard identifies alarm conditions. Figure 3: Alarm Dashboard WARNING: . The operator must always have a clear O NOT BLOCK VIEW OF THE LARM ASHBOARD view of the alarm dashboard when the device is connected to the patient, especially in noisy environments where caregiver may not hear alarms. -
Page 16: Back Panel
ANEL 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 Basic Setup label lists the steps to setup the device and includes a table that lists the tidal volumes for males and females based on height. -
Page 17: Device Accessories & Accompanying Documents
For information on device accessories refer to www.automedx.com SAVe II+ OPERATOR’S MANUAL > Page 17... -
Page 18: Patient Breathing Circuit
ATIENT REATHING IRCUIT Figure 8: Patient Breathing Circuit Diagram Oxygen Reservoir Tube Figure 9: Oxygen Reservoir Tube AC P OWER UPPLY ATTERY HARGER Figure 10: AC Power Supply / Battery Charger SAVe II+ OPERATOR’S MANUAL > Page 18... -
Page 19: Hard Carrying Case
ARRYING Figure 11: Hard Carrying Case SAVe II+ OPERATOR’S MANUAL > Page 19... -
Page 20: Prepare For Use
Prepare for Use To prepare the SAVe II+ for deployment the operator must: 1) Unpack device 2) Verify required contents are packaged in kit 3) Verify Patient Circuit 4) Verify Debris Filter Installation 5) Verify battery has adequate charge and charge as necessary 1: U NPACK EVICE... -
Page 21: Step 5: Charge Battery
WARNING: ELIVERED IDAL OLUME MAY DECREASE SIGNIFICANTLY WITHOUT ALARMING IF FINE PARTICULATES SAND ENTERS THE DEVICE MANIFOLD . The debris filter is not designed to filter EVER USE A WET OR MOIST DEBRIS FILTER chemical or biological agents and will not protect the patient from contaminated environments. -
Page 22: Setup For Use
WARNING: Inserting an HME or HMEF will increase the resistance and dead space of the Patient Circuit. Only use HMEs and HMEFs approved by AutoMedx. Nebulizers can increase the resistance of the HME / HMEF. SAVe II+ OPERATOR’S MANUAL > Page 22... -
Page 23: Step 3: Connect Patient Breathing Circuit
3: C ONNECT ATIENT REATHING IRCUIT Locate an unused SAVe II+ Patient Breathing Circuit in its original packaging. Remove patient circuit from packaging and connect to the appropriate SAVe II+ Manifold Port. Figure 15: Air/ O Intake Port and Breathing Circuit Connection Ports Figure 16: Breathing Circuit Connected 4: T URN ON... -
Page 24: Step 5: Verify Disconnect Alarm
Table 3: Adult Height Preset Values Height Rate Tidal volume Minute PIP Limit PEEP (BPM) (ml) Ventilation (LPM) (cmH2O) (cmH2O) 4’ 3” (129 cm) 4’ 6” (137 cm) 4’ 9” (145 cm) 5’ 0” (152 cm) 5’ 3” (160 cm) 5’... -
Page 25: Supplemental Oxygen
UPPLEMENTAL XYGEN If medically indicated, connect supplemental oxygen. To titrate supplemental oxygen to the patient, remove the black Intake Cap covering the Air/O Intake. See figure 12 and 14. Leave the debris filters in place. Fully expand the reusable Oxygen Reservoir tube and connect as pictured. -
Page 26: Noise Attenuator
NOTE: 1) FIO values assume the O tank or concentrator is delivering 100% oxygen 2) Setting the oxygen source flow rate higher than the minute ventilation of the ventilator will unnecessarily deplete oxygen supply faster. 3) Specified FIO values require a fully expanded oxygen reservoir tube. Failing to fully extend the tube may materially decrease FIO values for a given O flow rate. - Page 27 well so that it is not easily occluded. If the nipple becomes occluded, air will not be delivered to the patient and a disconnect alarm will trigger. If the attenuator is exposed to sand or dust wash it with water between uses. Make sure it is dry before reusing. In a dust or sandstorm, the black air intake port cap will do a better job than an attenuator at guarding against particulates getting into the pump.
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Page 28: Refining Ventilator Parameters
Refining Ventilator Parameters Once the SAVe II+ is setup and running refine the parameters as necessary based on ventilation protocols of your facility. Table 4: Ventilator Settings PARAMETER RANGE INCREMENTS RESPIRATORY RATE (RR) 0, 8 - 30 1 breath / min TIDAL VOLUME (TV) 200 - 800 10 ml... -
Page 29: Rr & Tv Combinations
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 30: Peak Inspiratory Pressure (Pip)
Table 6: Max Tidal Volume supported for each respiratory rate BPM Max TV BPM Max TV 0-15 12.0 12.2 12.5 12.2 12.4 12.3 12.4 12.2 12.4 12.2 12.4 12.0 12.4 12.2 12.3 12.0 (PIP) NSPIRATORY RESSURE The PIP limit controls the maximum pressure during the inspiratory phase before the pump shuts off and the PIP REACHED alarm activates. -
Page 31: Displaying Measured Pip And Peep
PEEP ISPLAYING EASURED To view the measured Peak Inspiratory Pressure (PIP) or measured Peak End Expiratory Pressure “PEEP”, press the Confirm button during normal operation when no changes are pending (i.e. indicators are not blinking). The most recent measured PIP and PEEP values to be displayed for 3 seconds. During this time, the RR and TV displays are cleared to help indicate that the device is displaying measured values. - Page 32 stomach (gastric insufflation) during use with a mask or other unprotected airway. Heart Icon LED blinks at compression rate of 100 per minute. If the MANUAL TRIGGER button is not pressed for 30 seconds “Breath” alarm will trigger indicating a breath needs to be delivered. To exit MANUAL / CPR Mode, the user can select and CONFIRM a HEIGHT PRESET or non-zero RESPIRATORY RATE.
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Page 33: Special Procedures
HANGE THE AutoMedx recommends placing the HMEF between the exhalation control valve and the patient connection port. See Figure 14 on page 22. AutoMedx recommends using the procedure outlined below when the HME filter needs to be changed while the patient requires PEEP. -
Page 34: How To Clear Debris Or Excess Fluid From Breathing Circuit
LEAR EBRIS OR EXCESS FLUID REATHING IRCUIT 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, follow steps below. 1) Disconnect circuit from patient airway. 2) Replace the active circuit with a new circuit if one is available. -
Page 35: Responding To Alarms
Responding to Alarms LARM VERVIEW The SAVe II+ has 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 36: Audible Alarm Indicator
UDIBLE LARM NDICATOR To help operators prioritize multiple simultaneous alarms, the audible alarm indicator of the SAVe II+ is divided into three levels of priority. The easiest way to distinguish between the priorities is how quickly the alarm repeats. Table 7: Audible Alarm Indicator Priority Audible Description Alarms Conditions... -
Page 37: Disconnect Alarm
DISCONNECT ALARM The DISCONNECT alarm triggers when the minimum pressure threshold has not been reached during the inspiratory phase of the ventilator. The ventilator will continue to cycle and alarm until the condition is resolved. Triggered when airway pressure is < 1.0 cmH O/110 ml of TV at end of inhalation or pressure increase during last 250ms of inhale is <... - Page 38 Device response: 1) Activate “PIP REACHED” visual alarm and high priority audible alarm. 2) End the inhalation cycle and enter the exhalation phase. 3) After exhalation attempts to deliver next breath cycle. NOTE: If the next breath is delivered without hitting the PIP limit then the alarm is resolved.
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Page 39: Battery Alarm
BATTERY ALARM The BATTERY low-priority alarm activates when less than 15% of battery capacity remains. To resolve connect the SAVe II+ to an appropriate external power source. Device response: Less than 15% of capacity: Low priority audible indicator activates for 30 seconds Last battery LED begins to flash Less than 8% of capacity: Medium priority audible indicator activates for 30 seconds... -
Page 40: Device Alarm
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: 1) Activating “DEVICE”... -
Page 41: High Peep Alarm
HIGH PEEP ALARM Alarm is triggered when measured PEEP is 5.0 cmH2O above the SET PEEP. Potential Cause: 1) Patient is not synchronizing with the ventilator. 2) Exhalation valve port is blocked or occluded. 3) Patient is not completely exhaling during the expiratory phase of the breath. Device responds by: 1) Activating “HIGH PEEP”... -
Page 42: High Minute Ventilation
HIGH MINUTE VENTILATION A High Minute Ventilation alarm triggers when the TV/RR combination requires a minute ventilation that exceeds 12.5 LPM. The device will not permit the operator to select these TV/RR combinations. See Table 6 on page 30 to see the max tidal volume supported by each respiratory rate. -
Page 43: Maintenance
MAINTENANCE The SAVe II+ ventilator is designed to operate with minimal maintenance. However, the device should be annually calibrated by an authorized service representative. To learn more or to schedule your service please visit www.automedx.com/service. ATTERY AINTENANCE All batteries degrade over time. If the battery will be stored at elevated temperatures store with 50% charge. -
Page 44: Replace Consumables
Debris filter Mask Heat and moisture exchanger (HME or HMEF) Reordering information is available at http://www.automedx.com BREATHING CIRCUIT The SAVe II+ breathing circuit is single use. Examine the breathing circuit tubes for cracking, discoloration, sharp edges, or other signs of damage. DO NOT attempt to use or repair damaged breathing circuits. -
Page 45: Storage
If you have any reason to believe the device is not within specification send in for service. For more service information please visit www.automedx.com/service. SAVe II+ OPERATOR’S MANUAL > Page 45... -
Page 46: Appendix A: Specifications
Appendix A: Specifications ENERAL Mode Continuous Mandatory Ventilation Control Time-cycled, volume targeted, pressure-limited Power 100 – 240 VAC / 50-60 Hz Battery Duratio1 9.25 Hours Time to Full Charge 1.4 hours Dimensions Ventilator: 6.5" x 6.25" x 2.0" | Storage-case: 13.8” x 12.1” x 6.8” Weight Ventilator: 2.8 LBS (1.3 kg) | Storage-case: 9.9 LBS (4.5 kg) NVIRONMENTAL... - Page 47 Ventilators set to simulate 5’9” patient with moderate ARDs Operating the ventilator while it is charging will increase time to full charge If stored at room temperature (15 – 20C) prior to use the ventilator will continue normal operation for up to 1.5 hours at the lower temperature extreme of -20 C.
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Page 48: Appendix B: Symbols Glossary
Appendix B: Symbols Glossary Symbol Explanation of Symbol Manufactured By. The full name, address and phone number of the legal manufacturer appears next to this symbol. European Authorized Representative. The full name and address of the Authorized Representative appears next to this symbol. This is the official contact for complaints when manufacturer is located outside EU. - Page 49 Class II Equipment Type BF Applied Part Waste Container One-way Valve Alternating Current Direct Current Catalog Serial Number Lot Number Use-by Date Do Not use if package is damaged SAVe II+ OPERATOR’S MANUAL > Page 49...
- Page 50 Non-sterile Fragile Temperature Limit IP24 Ingress Protection Latex Free Mute Battery Level Charge Compression Rate (CPR) Decrease Parameter Increase Parameter Patient Height SAVe II+ OPERATOR’S MANUAL > Page 50...
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Page 51: Appendix C: Re-Order Information
Appendix C: Re-Order Information ITEM MFG PN QUANTITY Patient Circuit, Single-use, Adult F20066-10 Case of 10 Heat Moisture Exchanger Filter (HMEF), Case of 10 E32113-10 Resupply Kit, Intake Filter x2 and cap M41113-5 Pack of 5 Intake Filter, Pack of 50 F20053-50 F20072-5 Extendable... -
Page 52: Appendix D: Principles Of Operation
Appendix D: Principles of Operation The SAVe II+ is a completely self-contained, small, lightweight, 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 pressure and device malfunction. - Page 53 mode), as in the event that a mask is used as the airway of choice, this setting will decrease the likelihood of gastric insufflation. While the RR is set to zero an alarm will sound if more than 30 seconds elapse since the last breath. To keep the patient safe, in MANUAL / CPR mode, the PEEP option is disabled so that the patient airway pressure returns to 0 after the delivered breath.
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Page 54: Appendix E: Limited Warranty
AutoMedx warrants to the original purchaser (“Customer”) of the SAVe II+ that if there is a defect in material or workmanship in the SAVe II+ and AutoMedx is notified of such defect within three (3) years of Customer’s original purchase, AutoMedx shall, in its sole... -
Page 55: Appendix F: Software Release History
ON 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.
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