AutoMedx SAVe II User manual

SAVe II Operation Manual

SAVe II OPERATION MANUAL  Page 3
Preamble
TrademarkInformation
SAVe II™ is a trademark belonging to AutoMedx, Inc. Copyright© 2015 All Rights Reserved.
The SAVe II™ logo and the names and marks associated with AutoMedx’s products are trademarks and/or
service marks of AutoMedx, Inc. and are registered and/or common law marks in the United States and
various other countries. No portion hereof may be reproduced or transmitted in any form or by any means,
for any purpose other than the recipient’s personal use, without the express written permission of
AutoMedx, Inc.
ContactInformation
Manufactured By:
AutoMedx, Inc.
440 Wrangler Dr. Ste 200
Coppell, TX 75019
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.AutoMedx.com
Authorized Representative in Europe:
(Regulatory Affairs Only)
Emergo Europe
Molenstraat 15
2513 BH The Hague,
The Netherlands
Tel: (31) (0) 70 345-8570
Fax: (31) (0) 70 346-7299
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 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.
It is important that this manual is read and understood in its entirety before operating the ventilator.
Operating or servicing this device without a complete understanding of its characteristics may cause harm
to the patient or user and may permanently damage the device.
The SAVe II is designed for use by trained personnel under the direction of a physician and in accordance
with applicable laws and regulations. This manual describes how to operate and respond to the ventilator,
but does not include instructions on how to respond to the patient. 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. Outside the United States check local laws for any
restrictions that may apply.
Service procedures, including annual calibration verification tests, routine and non-routine maintenance
operations are described separately in the SAVe II™ SERVICE MANUAL (P/N: M40101). For service
information contact: [e-mail]
FDA Tracking Requirements
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.
Please send the following information to [e-mail]:
Contact name
Title
Organization name
Street address
City, State, Zip
Contact phone number
Email address
Model Number and Serial Number
Disposition of the device

SAVe II OPERATION MANUAL  Page 5
TABLE OF CONTENTS
Preamble........................................................................................................................................3
Notice to Operators ................................................................................................................................ 4
FDA Tracking Requirements .................................................................................................................... 4
Safety Information.................................................................................................................................. 6
General Warning Statements .................................................................................................................. 7
Caution Statements ................................................................................................................................ 8
Use of Symbols ....................................................................................................................................... 9
INTRODUCTION............................................................................................................................10
Device Overview................................................................................................................................... 10
Indications for Use ................................................................................................................................ 11
Contra-Indications ................................................................................................................................ 11
Use Environment .................................................................................................................................. 11
Training Requirements.......................................................................................................................... 11
Features ............................................................................................................................................... 12
Risks & Benefits .................................................................................................................................... 12
DEVICE DESCRIPTION ...................................................................................................................13
User Interface....................................................................................................................................... 13
Description of Controls, Indicators and Displays..................................................................................... 14
Device Labeling..................................................................................................................................... 15
Alarm Dashboard.................................................................................................................................. 17
Device Disposables & Accessories.......................................................................................................... 18
PREPARE FOR USE ........................................................................................................................19
USING THE SAVE II ........................................................................................................................22
Setup for Use ........................................................................................................................................ 22
Manually Triggered Breaths .................................................................................................................. 31
Clearing Debris from Breathing Circuit................................................................................................... 33
Alarm Overview.................................................................................................................................... 34
Alarm Quick Reference Guide................................................................................................................ 35
RESPONDING TO ALARMS .......................................................................................................................... 37
MAINTENANCE .............................................................................................................................42
REPLACE CONSUMABLES ............................................................................................................................ 44
STORAGE ................................................................................................................................................ 45
SCHEDULED MAINTENANCE ......................................................................................................................... 46
APPENDIX A– SPECIFICATIONS1.............................................................................................................47
APPENDIX B–REGULATORY INFO/CLASSIFICATION/LIMITED WARRANTY .....................................................48
APPENDIX C–PRINCIPLES OF OPERATION .............................................................................................51
APPENDIX D-RE-ORDER INFORMATION .................................................................................................53
APPENDIX E–SOFTWARE RELEASE HISTORY .............................................................................................54

SAVe II OPERATION MANUAL  Page 6
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.
CAUTION
“CAUTION” statements alert the reader to potentially hazardous situations, which, if not avoided, could
result in equipment damage. These situations could indirectly cause death or serious injury if the
equipment damage causes the ventilator to operate improperly.

SAVe II OPERATION MANUAL  Page 7
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.
Patient Monitoring - Qualified personnel must constantly monitor patients. Such personnel should be prepared to
troubleshoot alarms, address equipment malfunctions and circumstances where equipment becomes
inoperative.
Alternative ventilation - An alternative means of ventilating the patient should be available at all times.
Pre-Use Functional Check - The operator should perform a quick functional check to ensure proper operation before
connecting to a patient.
Ventilator Presets - Ventilator height presets may only be used on adult patients. Do not use presets when ventilating
children. Presets are intended to aid operators with the initial setup but may not be appropriate for extended periods
or in all situations. Operators should refer to appropriate guidelines or their medical director to determine the
suitability of these presets for a given situation.
Sand/Dust/Debris Inside Manifold – Do not operate the SAVe II if sand, dust or other debris have entered the ports.
Equipment Damage/Malfunction - Do not operate the SAVe II, any components, or accessories that appear to be
damaged, fail Checkout tests, or malfunction in any way. 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 use of the device immediately, unplug, power off the device, and disconnect external oxygen.
Preventative Maintenance - Failure to follow Preventative Maintenance procedures described in this manual
could result in device malfunction. Refer to information on page 42.
Battery - If you suspect the internal battery is damaged, take the unit out of service immediately.
Accessories - Serious harm to the patient may result from the use of unauthorized parts or accessories. Only use
accessories approved by AutoMedx. Refer to information on page 17.
Use with Oxygen Concentrator - Oxygen concentrators are not intended as a primary source of oxygen and a back-
up
oxygen source should always be available.
NOT MRI Compatible - Do not put the SAVe II, any components, or accessories inside an MRI machine.
Use Outside Specified Normal Operating Conditions - The performance of the SAVe II may be materially affected if it
is used outside of the specified NORMAL OPERATING CONDITIONS. Refer to information on page 11.
Contaminated Environment - Do not use the SAVe II in contaminated environments. The debris filter is designed
to
stop particulates, not chemical or biological agents.
Cross Contamination - Do not reuse the Breathing Circuit as it may cause cross contamination between patients. A
patient treated by mechanical ventilation is at risk of infection. Dirty or contaminated equipment is a potential
source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and
following any maintenance procedure to reduce the risk of infection.
Audible Indicators - Do not allow the ventilator’s Alarm Speaker Port to become covered or obstructed in any way by
stickers, labels, clothing, sand, mud, debris or other equipment.
Noisy Environments - Alarms may be difficult to hear in noisy environments. Take extra precautions to closely
monitor the patient and ventilator in these environments.
Visual Alarm Indicators - Do not cover or obstruct visual alarm indicators in any way. Always have the user
interface in view.
Airway Obstructions - Vomitus and other debris may obstruct the patient end of the Patient
Breathing Circuit.
Refer to instructions on clearing debris from the Patient Breathing Circuit Error! Bookmark not defined..
Unintentional Changes - In order to prevent accidental changes to the settings or inadvertently shutting off the
device, verify the user interface is protected from unintentional contact.

SAVe II OPERATION MANUAL  Page 8
Secure Device - During evacuation or transport, it is strongly recommended that the SAVe II be secured to the
patient or litter. Failure to properly secure the SAVe II could damage the device and could harm the patient by
dislodging the Breathing Circuit or airway.
Fire Hazard - If using supplemental oxygen, avoid smoking or open flames. Leaks at oxygen connections can cause
dangerous O2 levels in the vicinity of the leak. To avoid the risk of ignition, visually inspect oxygen connections
before and after connecting supplemental O2 and take measures to properly ventilate the area. Do not use oil, grease,
or combustible lubricants (only those approved for oxygen use) in contact with any part of
the ventilator, regulator,
or cylinder.
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 information on page 21.
Caution Statements
Risk of Equipment Interference - Potential electromagnetic interference may occur at levels greater than 20 V/m.
Avoid use of the device in environments that may have high electromagnetic levels. The AC Adapter (Battery
Charger) and its associated cables are in compliance with the requirements of 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. Contact AutoMedx at [e-mail] for a SAVE II SERVICE MANUAL
(P/N: M40101) and qualification requirements.
Charging Battery/External Power - Only use the Battery Charger specified for use with the SAVe II. The battery
should be charged in accordance with the instructions on page 21.
Wet Environments - If using the SAVe II in a wet environment take precautions and protect the device by covering
it with a protective barrier.
Storage Environment - Storage of the SAVe II outside the specified storage environment may materially impact
device performance and permanently damage and/or shorten the life of the device.
Battery Replacement & Disposal - The SAVe II battery should only be replaced by qualified service personnel
Batteries should be disposed of according to local environmental legislation. Refer to SAVE II SERVICE MANUAL
(P/N: M40101).
Transport of Lithium-Ion Batteries - Regulations govern the transportation of lithium ion batteries and devices that
have lithium ion batteries. Check the appropriate statutes to ensure compliance before
transporting the device
and / or the batteries.
Uncertain Power Sources / Automobile Power Outlets - Before connecting the SAVe II AC Power Supply to
uncertain power input sources, verify the SAVe II internal battery is in good condition and fully charged. Connecting
to an improperly rated power source may damage the AC Power Supply, preventing the SAVe II battery from charging.
Autoclave/Sterilization - Never place any part of the SAVe II or its accessories in an Autoclave. Unless otherwise
indicated, the 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.

SAVe II OPERATION MANUAL  Page 9
Use of Symbols
Symbol
Title & Usage
Symbol
Title & Usage
CAUTION ON/OFF POWER BUTTON
CONSULT INSTRUCTION FOR USE MUTE
DO NOT REUSE CLASS II EQUIPMENT
DATE OF MANUFACTURE TYPE BF APPLIED PART
MANUFACTURER ONE-WAY VALVE
AUTHORIZED REP (EUROPE)
ALTERNATING CURRENT
WASTE CONTAINER DIRECT CURRENT
CATALOGUE NUMBER
CONTAINS OR PRESENCE OF
PHTHALATE
SERIAL NUMBER
LATEX FREE
BATCH CODE CE MARKED PRODUCT
USE-BY DATE BATTERY LEVEL
DO NOT USE IF PACKAGE IS DAMAGED CHARGE
NON-STERILE COMPRESSION RATE
FRAGILE,HANDLE WITH CARE DECREASE PARAMETER
TEMPERATURE LIMIT INCREASE PARAMETER
IP24 ENCLOSURE PROTECTION RATING
PATIENT HEIGHT

SAVe II OPERATION MANUAL  Page 10
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.
The SAVe II uses a battery-powered compressor to deliver air to a patient for up to 10 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, FiO2can be increased if compressed oxygen or
an oxygen concentrator is available.
Responders can quickly deploy the SAVe II by selecting the patient’s height. The unit dials in a preliminary
tidal volume and respiratory rate appropriate for adults of that size. After initial setup, users with an
appropriate
level of training can fine-tune the settings. To mitigate the risk of patient injury, airway
pressure is monitored and users are alerted to potentially dangerous low and high pressure situations. In a
high pressure situation, the pump will stop if the pressure reaches the peak inspiratory pressure (PIP)
cutoff. The PIP setting is adjustable but defaults to 30 cmH2O. Visual alarm indicators located at the bottom
of the user interface help the user quickly troubleshoot issues.
FIGURE 1: MULTIPLE VIEWS OF SAVe II

SAVe II OPERATION MANUAL  Page 11
Indications for Use
The SAVe II series is intended to provide short-term ventilatory support to adults during CPR or when
Positive Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe II series
is appropriate for adults that weigh at least 45 kg (approximately 99 lbs.). It is intended to be used in the
pre-hospital, field hospitals and transport environments.
Federal law (U.S.A) restricts this device to sale by or on the order of a licensed medical practitioner. Outside the
U.S.A. check local laws for any restrictions that may apply.
Contra-Indications
ABSOLUTE CONTRA-INDICATIONS
The SAVe II should not be used in situations where Positive Pressure Ventilation (PPV) is contra-indicated.
RELATIVE CONTRA-INDICATIONS
Do not use the device for extended periods without monitoring blood gases. As duration of use increases,
the need for close monitoring of CO2 and O2 levels also increases.
Do not set PEEP above zero (0) when performing CPR.
Spontaneously breathing patients may not synchronize with ventilator. Consider discontinuing use if a
spontaneously breathing patient has difficulty synchronizing with the device.
Use Environment
NORMAL OPERATING ENVIRONMENT
The SAVe II is intended for use in pre-hospital and in-hospital settings. Performance specifications are
based on use
in environments with ambient temperatures of 0 to 50°C (32 to 122°F), relative humidity
from 15 to 95%, and atmospheric pressures from 70 to 110 kPa.
EXTREME OPERATING ENVIRONMENT
Attempting to operate the ventilator outside the temperatures range of -10 to 50°C (14 to 122°F) may result
in ventilator failure and harm to the patient.
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. Do NOT at any time operate
or store the Device in environments outside specified EXTREME OPERATING ENVIRONMENTS. This may
result in ventilator failure and/or harm to the patient.
Training Requirements
Operators must be familiar with the contents of this manual and trained to provide primary response to
a respiratory emergency.

SAVe II OPERATION MANUAL  Page 12
Features
Height based presets enable rapid setup
Presets dial in lung protective ARDSnet based parameters based on ideal body weight (6 ml/kg)
Small size and weight make it the most portable ventilator on the market
Ventilate a patient on the internal battery for 10 hours (runtime varies based on settings)
Adjustable tidal volume (TV), respiratory rate (RR), peak inspiratory pressure (PIP) and positive end
expiratory pressure (PEEP)
Alarm Dashboard simplifies troubleshooting
No compressed gas tank required
Deliver FiO2up to 100% using included oxygen reservoir and flow regulated oxygen source
Displays breath to breath PEEP and PIP measurements
Risks & Benefits
The SAVe II is designed to enable a medic or other first responder with limited training to provide life-
sustaining ventilation until the patient can be evacuated to a higher level of care. The device is easy to use,
lightweight, and intended to be used on the battlefield, in the pre-hospital environment or during
transport. The operator simply selects the height of the patient and the device dials in an ARDSnet Protocol
recommended tidal volume of 6 ml/kg of ideal body weight. These presets may not be appropriate for all
patients or all conditions. The operator must continue to monitor the patient and make adjustments as
necessary.
The SAVe II has a number of benefits over a bag-valve-mask (BVM). First, it offers a breath-to-breath
consistency not achievable with a BVM. This is especially important in high stress situations where studies
have demonstrated rescuers are prone to hyperventilating patients. The SAVe II delivers a consistent tidal
volume at a consistent rate. 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. The SAVe II will detect a patient’s inspiratory
effort and automatically trigger a breath.
Unlike Pneumatic Resuscitators, the SAVe II does not require compressed air to operate, however it will
accept low-pressure supplemental oxygen if a higher FiO2 is needed. Devices relying on high-pressure
oxygen tanks in a combat zone pose a fire and explosion hazard, tend to be large and only ventilate for a
short period of time.
The medic administering care must monitor the patient to ensure adequate gas exchange is occurring. The
SAVe II is designed with multiple system checks to monitor proper operation of the device and safety of
the patient. If an alarm condition occurs, the SAVe II will emit both a visual and audible alarm. In addition,
depending on what triggered the alarm, the SAVe II will limit functionality as necessary to avoid patient
injury. For example, the device will trigger an alarm and cutoff power to the pump when the delivery of
additional air exceeds the peak inspiratory pressure (PIP) limit. This safety feature is designed to prevent
over inflation and alerts the medic to fix the fault that triggered the alarm.

SAVe II OPERATION MANUAL  Page 13
DEVICE DESCRIPTION
 User Interface
 Device Labels
 Alarm Dashboard
 Device Disposables & Accessories
User Interface
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 buttons. With the exception of Power On/Off, Mute and Manual Trigger,
control changes require confirmation to prevent inadvertent changes. Controls requiring confirmation
are associated with adjusting ventilator parameters and require operators to select (press) the
appropriate Height Preset or +/- parameter control button until the desired setting is reached then
press Confirm. The parameter display will blink with the prospective setting for 10 seconds or until the
confirm button is pressed. If not confirmed, the device will revert back to the current device setting and
the numerical parameter displays will turn solid.
Green LED indicators communicate the current normal operating status of the device. Red alarm codes
and the audible alarm indicator signal an alarm condition. Solid indicators are intended to only
communicate information such as a current device settings or past alarm conditions. Blinking indicators
are intended to signal that operator intervention is needed due to a control change requiring
confirmation or an active alarm condition.
Green numerical parameter displays communicate device parameter settings and measured pressures.
Similar to blinking indicators, blinking parameter displays are intended to signal that operator action is
needed to confirm a setting. If the Confirm 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
(Gray) Primary indicators, displays and controls generally used during initial setup.
LOWER UI PANEL
(Black)
Secondary indicators, displays and controls generally used to monitor and
fine tune ventilator parameters.
ALARM PANEL
(Black – Bottom
of UI Panel)
Alerts operator to potential issues with operation of device.

SAVe II OPERATION MANUAL  Page 14
Description of Controls, Indicators and Displays
REFERENCE & NAME
DESCRIPTION
1 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.
2 Adult Height Presets Control and indicator used to set default ventilator parameters based on
patient height and monitor current setting.
3
Battery Life
Indicates remaining battery life.
4
Audible Alarm Indictor
Indicates an active alarm condition.
5
External Power
Indicates external power is connected.
6
Adult Height Presets
Indicates device set using preset patient height parameters.
7
User Defined
Indicates device set to user defined parameters.
8 Respiratory Rate
Control and display used to set the RESPIRATORY RATE (RR) and monitor the
set number of breaths delivered each minute.
9 Tidal Volume
Control and display used to set the TIDAL VOLUME (TV) and monitor the set
volume in milliliters of gas delivered each breath.
10 PIP
Control and display used to set the PEAK INSPIRATORY PRESSURE (PIP) limit
(Pressure Cutoff). Once the setting is confirmed the display stays fixed,
however, the device measures the peak pressure breath to breath. To see
the last measured Peak Inspiratory Pressure at the PATIENT CONNECTION
PORT press the confirm button
1
.
11 PEEP
Control and display used to set the POSITIVE END-EXPIRATORY PRESSURE
(PEEP) and display the set PEEP of each breath. By pressing the confirm
button during normal operation, the device will display the measured PEEP
maintained in the BREATHING CIRCUIT at the end of exhalation
1
.
12 Compression Rate Indicator blinks at a rate of 100/minute to aid users performing chest
compressions when device is in MASK CPR mode (RR set to zero (0).
13 Manual Trigger Control used to deliver a breath at the set tidal volume.
14 Confirm
Control and indicator used to prevent unintended changes. Blinking indicates
the ventilator parameter settings must be confirmed
to become active. When
all parameter settings are confirmed (solid) and no changes are pending,
pressing the Confirm button will cause the most recent measured PIP and
PEEP values to be displayed in the PIP and PEEP parameter displays for 3
seconds (Refer to instructions on page 28)
1
.
15 Mute
Silences an active audible alarm for 120 seconds. New alarm will override. If
alarm condition still presents after 120 seconds the audible alarm will
resume.
1 Feature available in devices programmed with firmware release R1.0.4 or later

SAVe II OPERATION MANUAL  Page 15
Device Labeling
FRONT PANEL LABEL /USER INTERFACE
FIGURE 2: USER INTERFACE

SAVe II OPERATION MANUAL  Page 16
BACK PANEL LABELS
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
Device Serial Number
Quick alarm troubleshooting information
Battery capacity reference

SAVe II OPERATION MANUAL  Page 17
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: Never cover or obstruct the alarm panel. 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.
ALARM CODE
DESCRIPTION AND LIKELY CAUSE
RESPONSE
DEVICE
The device is outside its temperature range or a
software, mechanical or electrical issue has been
detected.
Page 40
DISCONNECT
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 37
PIP REACHED
The set Peak Inspiratory Pressure Limit has been
reached. Possible causes include: blockage of Breathing
Circuit or airway, low lung compliance (stiff lungs),
excessive tidal volume, and tension pneumothorax.
Page 38
BATTERY
Less than 10% of battery capacity remains. The unit
must be connected to an appropriate external power
source.
Page 39
HIGH PEEP
The measured PEEP is 5 cmH
2
O above set PEEP. Most
likely causes are blockage of the exhalation port or the
patient actively exhaling during the exhalation phase.
Page 40
HIGH MV
(Minute Vol.)
The combination of TV/RR requires a flow rate that
exceeds the pumps ability to deliver at an I:E ratio of
1:2. The device will not permit operator to select these
TV/RR combinations. Refer to information on page 29.
Page 41
BREATH
(CPR Mode)
More than 30 seconds have passed since the last
manually triggered breath. Only active in MASK CPR
MODE (RR set to zero).
Page 41
BREATH ASSIST
Indicates a patient inspiratory effort has been detected
and a patient triggered breath has been delivered.
Page 41
Refer to information on page 37 for instructions detailing how to respond to alarms.

SAVe II OPERATION MANUAL  Page 18
Device Disposables & Accessories
ITEM
PART #
DESCRIPTION
Breathing Circuit
M40105
Channels air to and from the patient’s airway.
Air Intake Debris
Filter
F20053
Protects internal components from dust, dirt and other
particles.
Air Intake Cap F20059
Protects the Debris Filter from direct exposure to
particles and water during storage or use when the
Attenuator or Oxygen Reservoir is not being used.
Oxygen Reservoir M40092
Allows delivery of up to 100% FiO
2
using a flow
regulated oxygen source.
Noise Attenuator M41112
Mitigates device noise when the Oxygen Reservoir or Air
Intake Cap is not in use.
AC Power Supply
E52240 /
M40090
Supplies device and battery with external power.
Power Cable (Type A)
E11021
Connects the AC Power Supply to external power.
Hard Carrying Case
F20055
Protects the system during transport and storage.
Head Harness1
E11001
Assists user in securing mask to patient.
Mask1 E11000
Basic non-invasive interface between Breathing Circuit
and patient.
Mask Inflation
Syringe
1 E10996 Used to re-inflate mask if necessary.
1 Items provided for convenience of user and may not be included in all kits. Please check with your distributor.

SAVe II OPERATION MANUAL  Page 19
PREPARE FOR USE
To prepare the SAVe II for rapid deployment, operator must:
1. Unpack device
2. Verify required contents are packaged in kit
3. Verify debris filter is installed
4. Verify battery has adequate charge
Step 1: Unpack Device
Inspect the transport container for evidence of damage during transit. If damaged, notify the delivery
service immediately. Carefully remove the ventilator and all accessories from the transport container.
Confirm you have received all items listed on the packing slip. Notify an authorized sales representative or
AutoMedx of any discrepancies. Examine the ventilator and accessories for visible damage. If damaged,
notify AutoMedx. Unless otherwise indicated, the SAVe II and its accessories are provided clean, not sterile.
It is best to keep all accessories packaged until needed.
Step 2: Verify Contents
INCLUDED IN SAVE II KIT
QTY
DESCRIPTION
PART NUMBER
1 EA
Ventilator
M50012
1 EA
Breathing Circuit, Ruggedized, Disposable, Single- Use
M40105
1 EA
Air Intake Debris Filter, Disposable
F20053
1 EA
AC Power Supply
E52240
1 EA
Power Cable (Type A)
E11021
1 EA
Mask and Inflation Syringe (included in some kits)
M40106
1 EA
Head Harness (4 point) (included in some kits)
E11001
1 EA
Attenuator (Sound Dampening U Shaped Tube), Reusable
M41112
1 EA
Oxygen Reservoir
M40092
1 EA
Air Intake Cap
F20059
1 EA
Operator’s Manual
M40100
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 appro
priate based on the training of the provider and needs of the patient. 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, contact [email protected]

SAVe II OPERATION MANUAL  Page 20
Step 3: 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. Two debris filters must be placed inside the “Air/O2 Intake” port of the SAVe
II at all times.
The AIR INTAKE CAP (P/N: F20059) protects the Debris Filter from direct exposure to particles and water
during storage and use when the Attenuator or O2 Reservoir is not being used. The notched edges of the
air intake port allow air to flow to the patient even when the Air Intake Cap is in place. In particularly dusty
or sandy environments the air intake cap should be used instead of the Attenuator.
Inspect the Air Intake Debris Filter prior to each patient use and replace if there is any sign of exposure to
moisture, dust, sand or other debris. 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.
AIR INTAKE CAP AIR INTAKE PORT & DEBRIS FILTER
FIGURE 3: AIR INTAKE PORT, DEBRIS FILTER & PORT CAP
WARNING:
Failure to properly maintain the debris filter can decrease delivered tidal volumes to the patient as
well as lower the life expectancy of the unit due to increased workload on the pump motor.
Immediately take device out of service if dust, sand or other debris have entered the internal SAVe II
system. The delivered tidal volume may decrease significantly without alarming.
Never operate the unit without a filter in place. Two clean Debris Filters must be in place at all times
Never use a wet or moist Debris Filter.
The Debris Filter is not designed to filter chemical or biological agents and will not protect the patient
from contaminated environments.
Only use filters designed for the SAVe II. Using other filters may impact device performance.

The AIR INTAKE CAP should be used when the Attenuator or O2reservoir is not being used.