Summary of Contents for AutoMedx SAVe 600x10
- Page 1 SAVe Ventilator Simplified Automated Ventilator Operator’s Manual Model 600x10 REF 70000...
- Page 3 This product is protected by issued and pending US and PCT patents. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). AutoMedx Inc. 1420 Lakeside Parkway Suite 102 Flower Mound, TX 75028 (T) 972.586.7500 (F) 972.408.4177 www.automedx.biz...
-
Page 5: Table Of Contents
ET-T ........................21 SE OF ETCO ....................21 SE WITH ETECTOR ....................22 SE WITH UPPLEMENTAL ..................23 ECURING THE E TO THE ATIENT AutoMedx Inc. 1420 Lakeside Parkway Suite 102 Flower Mound, TX 75028 (T) 972.586.7500 (F) 972.408.4177 www.automedx.biz... - Page 7 ELECTROMAGNETIC EMISSIONS AND IMMUNITY ..31 TECHNICAL OVERVIEW ........... 33 PRODUCT SPECIFICATION ..........35 ACCESSORY ORDER INFORMATION ......36 REGISTERING THE SAVE ..........36 AutoMedx Inc. 1420 Lakeside Parkway Suite 102 Flower Mound, TX 75028 (T) 972.586.7500 (F) 972.408.4177 www.automedx.biz...
-
Page 9: Glossary
Glossary Carbon Dioxide ET-Tube Endotracheal Tube Oxygen PEEP Positive End Expiratory Pressure SAVe Simplified Automated Ventilator Peak Inspiratory Pressure Bag Valve Mask Apneic Patient – Patient that is not breathing. Automatic Time-Cycle Resuscitator – Resuscitator in which the cycling between the inspiratory phase and expiratory phase is controlled automatically at time intervals determined by the control setting. -
Page 10: Specification Overview
SPECIFICATION OVERVIEW Model 600x10 BATTERY LIFE: up to 5.5 hours UNIT WEIGHT: 3.1 lbs (1.4 kg) UNIT SIZE: 6.75” x 6.25” x 2.5” (17 x 16 x 6 cm) TIDAL VOLUME: 600 mL/breath RESPIRATORY RATE: 10 BPM PIP LIMIT: 38 cmH FEATURES ... -
Page 11: Introduction & Background
Introduction & Background Properly ventilating a patient is a difficult task, even under ideal conditions. The need for an easy-to-use reliable automated ventilatory device is highlighted by the fact that the first time many medics ventilate a human patient will be on the battlefield. The SAVe was built to save lives by improving the triage capabilities of medics and elevating the standard of care in the far forward environment by replacing bag valve masks (BVM) with a simplified automated ventilation device. -
Page 12: Save Overview
Equipment that improves a medic’s remote triage capabilities, mitigates the potential for additional injury, reduces operator error and requires very little training is critically needed. To that end, AutoMedx developed the SAVe for combat medics. SAVe Overview The SAVe is a time cycled, constant flow, volume-targeted device with a peak inspiratory pressure limit of 38 cmH O designed as a safety measure to prevent barotrauma. -
Page 13: When The Save Should Not Be Used
When the SAVe Should Not be Used The SAVe is not intended for long-term use. The SAVe is not intended for children or adults weighing less than 45 kilograms (approximately 100 lbs.). Extreme care should be practiced when using the SAVe on patients that have non-compliant lungs as the pressure cut off may be reached before the targeted tidal volume is delivered. -
Page 14: General Warnings And Cautions
General Warnings and Cautions Failure to adhere to the WARNINGs and CAUTIONS below as well as to all of the instructions given in the manual could lead to death or serious injury to the user and/or to the patient. WARNING: Read the instructions contained within this manual BEFORE operating the SAVe. - Page 15 WARNING: If a mask is being used, a less than stated tidal volume may be delivered to the patient if an adequate seal is not maintained or if patient airway is compromised. WARNING: The use of accessories not approved for use by AutoMedx could result in unsatisfactory performance.
-
Page 16: Importance Of The Need To Adhere To Instructions
Importance of the Need to Adhere to Instructions The SAVe is a life-supporting medical device. Improper use of the device could lead to harm of the patient. Suppressing, neglecting or otherwise not responding quickly to alarms may cause serious harm or death. Pre-Deployment Checkout Procedure The procedures outlined below should be performed prior to using the SAVe. - Page 17 Picture SAVe Kit with 70000H 6515-01-581-8155 Hard Case Item* Qty. Picture SAVe Unit M50000 Patient Circuit w/ Debris M40003 6515-01-580-0768 Filter External E10478 6515-01-580-3522 Power Supply Head Strap E11001 Patient Mask E11000 Syringe E10996 Supplemental E10365 6515-01-580-3532 Tubing Hard Case** F20020 6515-01-588-8198 *Configurations vary depending on kit type.
-
Page 18: Step 2 - Debris Filter
The debris filter should be cleaned or replaced whenever visible buildup of dirt is observed or it has been exposed to biomaterial such as blood or vomitus. AutoMedx recommends cleaning or replacing the debris filter after each patient use. STEP 3 – Battery Life The battery life of the SAVe should be verified prior to deployment. -
Page 19: Step 4 - High Pressure Alarm
If the SAVe unit has insufficient battery life remaining, refer to the Maintenance section for instruction on how to charge the battery. Please note that even if all charge indicator lights are illuminated the device may last as little as 3.5 hours. A fully depleted battery requires 14 hours to fully recharge. -
Page 20: Patient Circuit (Valve)
visual alarms and audible alarms will be suppressed. The following switch position to the right will activate audible alarms and suppress visual alarms. The final setting suppresses all audible and visual alarms. Alarms should only be fully suppressed when absolutely necessary. Icons at each position have been provided as a visual reminder. - Page 21 It may be necessary to remove the patient valve from the circuit and clear any debris which may be blocking the airway. Reconnect patient connection port to valve once cleared. Do NOT block valve ports. Airflow Direction Pressure Tubing Figure 8: Correctly Assembled Patient Circuit WARNING: Emergency Air Intake and Exhaust –...
-
Page 22: Using The Save
Using the SAVe Step Procedure Look, listen and feel for breathing and pulse. Do not connect the SAVe to spontaneously breathing patient who may become out of sync with, or “buck”, the ventilator. Verify the airway is not blocked. Clear any visible debris or excess fluids from the patient’s mouth. - Page 23 Procedure Connect the patient connection port to the airway device or mask. Only use masks approved by AutoMedx. Never use a mask with a pop-off valve or filter. Turn the SAVe ON by rotating the knob one position from (O) to (I).
- Page 24 Step Procedure Supplemental O may be connected to the patient if necessary. The use of supplemental O may slightly increase delivered volume. The FiO chart indicates the oxygen concentration delivered to the patient within ±10%. Secure SAVe to the patient. When operating the SAVe in wet environments, users should take...
-
Page 25: Importance Of The Need To Monitor The Activity Of The Device
Patient specific factors such as lung compliance and airway resistance (i.e. higher resistance decreases operation time as does lower lung compliance) For more detailed battery specifications, contact AutoMedx. Low Battery Alarm Once the bottom battery LED begins to blink, the ventilator has approximately 45-60... -
Page 26: High Temperature Alarm
prepared to replace the unit or ventilate the patient by other means. If the device alarm is engaged with the low battery alarm, little or no air is being delivered to the patient. Immediately plug in the device to external power or manually resuscitate. High Temperature Alarm The four battery lights will begin to blink when the internal temperature of the SAVe reaches 60°C. -
Page 27: Device (Non-Field Serviceable) Alarm
The SAVe has been kitted for immediate use situations; however, the mask, head strap and ETCO detector which may be included with the kit are not manufactured by AutoMedx. Please refer to their instructions for use. This manual includes instructions and information on accessories manufactured by AutoMedx and instructions for those accessories not manufactured by AutoMedx. - Page 28 Do not suppress the alarms unless absolutely necessary, especially while using a mask. Only use masks approved by AutoMedx. Under no circumstances should a mask equipped with any type of filter, one way valve, or open oxygen/air port be used.
-
Page 29: Use Of Et-Tube
Figure 13. To ensure compatibility and proper operation, only use ETCO detectors approved by AutoMedx. All instructions and directions included with the sensor should be followed. An ETCO2 detector can be used to confirm airway placement and detect approximate ranges of end-tidal CO Be aware that if using an ETCO detector, vomitus may obstruct the airway. -
Page 30: Use With Supplemental O 2
Use with Supplemental O The SAVe has the capability to accept low pressure supplemental air or oxygen. Standard medical grade tubing is connected from the air source’s flow-regulated output valve to the supplemental O port on the SAVe (see Figure 14). The O must be regulated at the source. -
Page 31: Securing The Save To The Patient
Securing the SAVe to the Patient During evacuation or transport, it is strongly recommended that the SAVe be secured to the patient or litter. AutoMedx recommends using rolled gauze (ex: Kerlix) to wrap the SAVe and patient together, generally using an arm. -
Page 32: Maintenance
The procedures contained within this manual are intended to be performed in the field by the end user. A Preventative Maintenance Manual containing complete maintenance information is available. To request this manual, please contact AutoMedx at 972-586-7500 or email at service@automedx.biz. -
Page 33: Cleaning
C) to 104 F (40 3 Months NOTE: The SAVe internal battery is not field replaceable. Please contact AutoMedx for further instructions if the battery must be replaced. Cleaning Keep the SAVe and its accessories clean at all times. Under no circumstances should the SAVe unit be disassembled. -
Page 34: Annual Maintenance
The medic should replace the unit immediately or begin ventilating by other means. Instructions on How to Safely Dispose of the Device If the SAVe unit is no longer in use, please return the unit to AutoMedx’s facilities for proper disposal. Please contact AutoMedx for packaging and mailing instructions. -
Page 35: Troubleshooting
Troubleshooting The SAVe has three alarm types as described below. Ensure that the light indicators are not suppressed while troubleshooting. Alarm Overview Figure 17: Alarm Overview Patient Alarms The patient alarm may be triggered by one of the events listed below. Please note once the problem that triggered the alarm is fixed, the alarm will cease and the ventilator will begin proper operation on its own. - Page 36 Situation The ventilator motor repeatedly attempts to start but quickly stops Likely Source Blockage Possible Begin troubleshooting with the patient and work towards the ventilator Solution 1. If the problem cannot be addressed quickly, consider ventilating by other means or begin rescue breathing. 2.
-
Page 37: Device Alarms
Situation The alarm is intermittent. The alarm sounds and the pump turns off for several seconds and as air is released, the alarm ceases and the pump resumes again, repeating every several breaths. Likely Source Breath stacking (insufficient amount of air is being exhaled from the lungs between breaths). -
Page 38: Limited Warranty
AutoMedx warrants to the original purchaser (“Customer”) of the SAVe that if there is a defect in material or workmanship in the SAVe 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 replacement of such defective part(s) at no charge to the Customer, provided that this warranty provision is not applicable to batteries or used consumables. -
Page 39: Electromagnetic Emissions And Immunity
Electromagnetic Emissions and Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The SAVe Portable Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SAVe Portable Ventilator should assure that it is used in such an environment. - Page 40 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The SAVe Portable Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SAVe Portable Ventilator should assure that it is used in such an environment. IEC60601 Compliance Immunity Test...
-
Page 41: Technical Overview
Technical Overview The SAVe’s pneumatic subsystem uses an internal air pump to deliver ambient air to the patient. During the inhalation cycle, ambient air is drawn into the pump through the air input port. If needed, supplemental O may be connected to an additional port. As air is pushed from the pump into the internal manifold, a pneumatically connected pressure sensor monitors the pressure of the air delivered to the patient. - Page 42 enters into an exhale cycle. If it reaches that limit quickly, it triggers an alarm suggesting there is a blockage. The audible alarm sounds at a minimum decibel level of 70 db. The SAVe is an FDA Class II device. The patient breathing circuit and accompanying accessories are all “Type B”...
-
Page 43: Product Specification
Product Specification Dual Control Continuous Mandatory Ventilation Operating Modes: (DC-CMV) Primary Control: Time Secondary Control: Pressure Breath Target: Volume Targeted Flow Rate: 18 LPM Breath Rate 10 BPM Minute Volume 6 LPM Lung Compliance = 600 mL/breath Tidal Volume 50 mL/cmH Airway Resistance = 5 Lung Compliance = O/L/sec... -
Page 44: Accessory Order Information
Accessory Order Information Please contact AutoMedx at 972-586-7500 to order any accessory. The SAVe is only to be used with accessories pre-approved by AutoMedx. Part # Description Weight Dimensions Ruggedized Patient Breathing M40003 6515-01-580-0768 2 oz 3.25’L x 2”W x 1”D... - Page 45 THIS PAGE INTENTIONALLY LEFT BLANK...
Need help?
Do you have a question about the SAVe 600x10 and is the answer not in the manual?
Questions and answers