SAVe II+ OPERATOR’S MANUAL > 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
Page 1: ...SAVe II Operator s Manual INSTRUCTIONS FOR USE...
Page 2: ...the COVID 19 situation evolves Please go to www automedx com support to find current product literature The information contained in this manual is applicable to the product with which it was shipped...
Page 3: ...protected by U S and international copyright and other intellectual property laws and treaties Your rights to use the Software are subject to such laws and treaties and the following terms Your purcha...
Page 4: ...the ventilator in the instructions for use of the ventilator or accessory as the ventilator might not function correctly leading to the risk of patient death or additional serious deterioration of hea...
Page 5: ...AMINATED ENVIRONMENT Take appropriate precautions The debris filter is designed to stop particulates not chemical or biological agents IMMEDIATELY PRIOR TO USE PRE USE CHECK Verify functionality of th...
Page 6: ...E VENTILATOR or place in a position that affects proper operation for example by placing the ventilator under a blanket or in a position where tension is placed on the Patient Circuit that may cause i...
Page 7: ...void 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 AUTOCLAV...
Page 8: ...Front Panel 13 Alarm Dashboard 15 Back Panel 16 Port and DC Jack 16 DEVICE ACCESSORIES ACCOMPANYING DOCUMENTS 17 Patient Breathing Circuit 18 AC Power Supply Battery Charger 18 Hard Carrying Case 19...
Page 9: ...OCEDURES 33 How to Change the HMEF 33 How To Clear Debris or excess fluid From Breathing Circuit 34 RESPONDING TO ALARMS 35 Alarm Overview 35 Audible Alarm Indicator 36 DISCONNECT ALARM 37 PIP REACHED...
Page 10: ...CO2 and O2 levels also increases This is especially true for patients over 6 9 Spontaneously breathing patients may not synchronize with ventilator If spontaneously breathing patient has difficulty sy...
Page 11: ...tion the SAVe II unlike a BVM frees up the responder to address other injuries attend to other patients or further assist in transporting the patient The SAVe II at the 5 9 preset values will provide...
Page 12: ...ice Overview VISUAL INDICATORS Green LED indicators communicate the current normal operating status of the device Green numerical parameter displays communicate device parameter settings and measured...
Page 13: ...es require confirmation to prevent inadvertent changes to device settings Parameter adjustments require operators to select press the appropriate HEIGHT PRESET or the parameter control buttons until t...
Page 14: ...toff 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 P...
Page 15: ...has been reached Possible causes include blockage of Breathing Circuit or airway low lung compliance stiff lungs excessive tidal volume and tension pneumothorax BATTERY Low battery alarm Audible prior...
Page 16: ...e that lists the tidal volumes for males and females based on height The Quick Alarm Troubleshooting label lists the most common conditions associated with each alarm PORT AND DC JACK The SAVe II has...
Page 17: ...icles and water AC Power Supply PN M42090 1 EA Supplies device and battery with external power Cord type based on customer location Hard Carrying Case PN F20065 1 EA Water and dust proof case that pro...
Page 18: ...R S MANUAL Page 18 PATIENT BREATHING CIRCUIT Figure 8 Patient Breathing Circuit Diagram Oxygen Reservoir Tube Figure 9 Oxygen Reservoir Tube AC POWER SUPPLY BATTERY CHARGER Figure 10 AC Power Supply B...
Page 19: ...SAVe II OPERATOR S MANUAL Page 19 HARD CARRYING CASE Figure 11 Hard Carrying Case...
Page 20: ...erify the Breathing Circuit PN F20066 is new and packaged with original labeling Confirm there are no visible signs of damage Verify shelf life has not expired STEP 4 VERIFY DEBRIS FILTER INSTALLATION...
Page 21: ...of the SAVe II 2 Verify charge indicator light lightning bolt icon is illuminated 3 Monitor charge status using the Battery Level Indicator WARNING DELIVERED TIDAL VOLUME MAY DECREASE SIGNIFICANTLY WI...
Page 22: ...hed protocols to establish and confirm airway placement and seal STEP 2 OPTIONAL INSTALL HMEF INTO BREATHING CIRCUIT A heat and moisture exchanger filter HMEF may be added to the SAVe II patient circu...
Page 23: ...sets default to 6 ml kg of ideal body weight for a male There is a look up chart in the Quick Start Guide and on the bottom of the device that lists the tidal volume for male and females which can be...
Page 24: ...PROCEDURE PASS CRITERIA Completely block patient connection port with your hand PIP REACHED visual alarm indicator begins blinking within 1 breath Pump turns off for a few seconds and then turns on br...
Page 25: ...set the desired FIO2 calculate the minute ventilation by multiplying the set tidal volume by the respiratory rate and find the column below that reflects the liters per minute being delivered See A Sl...
Page 26: ...oir tube Place end of oxygen reservoir tube in a location that will prevent sand or dust from entering The oxygen supply must be shut off when ventilation is interrupted The line connecting the ventil...
Page 27: ...t particulates getting into the pump Attach the attenuator by 1 Remove the black Intake Cap from air intake port See Figure 12 2 Attach the attenuator to air intake port Leave the debris filter in pla...
Page 28: ...breath when the operator provides one The breath assist function see breath assist section is disabled when in MANUAL CPR Mode to prevent false triggering caused by chest compressions TIDAL VOLUME TV...
Page 29: ...tings from 600 ml at 20 BPM to 400 ml at 30 BPM both of which are permitted the user would first decrease the TIDAL VOLUME to 400 ml before increasing the RESPIRATORY RATE to 30 BPM Trying to increase...
Page 30: ...will cut the inspiratory phase short and less TV than indicated will be delivered to the patient Before increasing the PIP Limit consider increasing respiratory rate and decreasing tidal volume Do not...
Page 31: ...e the device to show the pending ventilator settings The SAVe II does not have an inspiratory hold feature so plateau pressure cannot be measured The peak inspiratory pressure will be slightly higher...
Page 32: ...ill only deliver breaths when MANUAL TRIGGER button is pressed ACTION EXPECTED DEVICE RESPONSE 1 Set TIDAL VOLUME TV indicator blinks 2 Decrease RESPIRATORY RATE to zero 0 MANUAL TRIGGER and RR indica...
Page 33: ...alarm for the time being c Reconnect the HME to the breathing circuit less abruptly d Repeat as needed so that the HIGH PEEP alarm is not flashing solidly illuminated is permissible 6 If the HIGH PEE...
Page 34: ...t as necessary to empty contents then reassemble Make sure there is not debris or fluid in the control or pressure line 4 Verify if proper operation of the circuit by blocking the patient connection p...
Page 35: ...sounds except the HIGH MV Alarm which is strictly a visual alarm and Low PEEP which is an audible alarm 2 Depending on the alarm the SAVe II may take other actions such as terminating an inspiration...
Page 36: ...e 7 Audible Alarm Indicator Priority Audible Description Alarms Conditions High Three closely spaced beeps with a short pause followed by two closely spaced beeps Repeats every 2 5 seconds Disconnect...
Page 37: ...e prepared to ventilate with alternative method What to do 1 Verify all three patient circuit tubes are firmly connected to the ventilator 2 Verify breathing circuit is firmly attached to airway 3 Ver...
Page 38: ...or narrow bends in breathing circuit b Verify correct placement of the airway and that it is clear of obstructions c Check to see if patient has tension pneumothorax 2 Low Lung Compliance If the alar...
Page 39: ...breaths Open exhalation valve Therapy control indicators are cleared Alarm continues to sound All button presses except MUTE and POWER are disabled What to do 1 Connect to an external power source usi...
Page 40: ...the device off then on to clear transient alarms If this does not address the problem begin ventilating using another method See if the error code corresponds to one of the following potentially field...
Page 41: ...ratory Rate This may resolve the alarm by providing the patient more time to fully exhale 4 Note Verify Minute Volume requirements are still being met If patient is asynchronous with ventilator consid...
Page 42: ...ctivating the BREATH visual alarm and high priority audible alarm What to do 1 Press MANUAL TRIGGER if a breath is indicated 2 Increase RR above 0 to exit MANUAL CPR mode if indicated BREATH ASSIST AL...
Page 43: ...00mAh battery is used the SAVe II will run for 9 25 hours when set to 5 9 Adult Preset Table 8 Charge Retention by Storage Temperature 21 C 70 F 45 C 113 F 1 Month 97 92 3 Months 94 87 6 Months 93 83...
Page 44: ...ontaining ammonium chloride other chloride compounds more than 2 glutaraldehyde phenols or abrasive cleaners Under no circumstances should the SAVe II or its accessories be immersed in liquid If the S...
Page 45: ...2 to 104 F For extended storage periods the SAVe II should be stored indoors out of direct sunlight and in a clean environment The best storage temperature is between 10 and 30 C 50 to 80 F The relati...
Page 46: ...41 to 113 F Transient 20 to 50 C 4 to 122 F Storage Temperature4 Short Term 0 to 40 C 32 to 104 F Long Term 0 to 30 C 32 to 86 F PARAMETERS RANGE RESOLUTION TOLERANCE Inspiratory Time Seconds 0 667 to...
Page 47: ...specified at ambient temperatures and pressure ATP Critical care ventilators often quote the volume of the gas as it is in the patient s lungs BTPS where the higher temperature and more humid environm...
Page 48: ...ized Representative appears next to this symbol This is the official contact for complaints when manufacturer is located outside EU XXXX CE Mark 4 digits after the CE or underneath the CE refer to Not...
Page 49: ...OPERATOR S MANUAL 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...
Page 50: ...e II OPERATOR S MANUAL Page 50 Non sterile Fragile Temperature Limit IP24 Ingress Protection Latex Free Mute Battery Level Charge Compression Rate CPR Decrease Parameter Increase Parameter Patient Hei...
Page 51: ...HMEF Case of 10 E32113 10 10 Resupply Kit Intake Filter x2 and cap Pack of 5 M41113 5 5 Intake Filter Pack of 50 F20053 50 50 Extendable O2 Reservoir Tube Pack of 5 F20072 5 5 Noise Attenuator Pack of...
Page 52: ...SURE PEEP CMH2O and PEAK INSPIRATORY PRESSURE PIP limit CMH2O in the User Defined section of the user interface In certain situations like during CPR the user may desire to control when a breath is de...
Page 53: ...he SAVe II also accepts supplemental oxygen to increase the FIO2 to the patient This is done using a low flow oxygen source up to 12 5 L min and an extendable oxygen reservoir tube that connects betwe...
Page 54: ...hip of the SAVe II or the battery or any other component of the SAVe II shall be at AutoMedx s sole and exclusive discretion repair or replacement of the defective SAVe II or component thereof as the...
Page 55: ...II product Valid proof of purchase required Disclaimer Some countries states or provinces do not allow the exclusion or limitation of implied warranties or the limitation of incidental or consequentia...
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