Harvard Apparatus Inspira ASV MA1 55-7058 User Manual Download Page 1

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Harvard Inspira

Advanced Safety Ventilator

User's Manual

Publication 5404-001-REV-C

Inspira Advanced Safety Ventilator,
Volume Controlled

MA1 55-7058

Inspira Advanced Safety Ventilator,
Pressure Controlled

MA1 55-7059

Summary of Contents for Inspira ASV MA1 55-7058

Page 1: ... Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Inspira Advanced Safety Ventilator Volume Controlled MA1 55 7058 Inspira Advanced Safety Ventilator Pressure Controlled MA1 55 7059 ...

Page 2: ...ng will be offered for our products which are within the scope of the WEEE Directive Products falling under the scope of the WEEE Directive available for sale after August 13 2005 will be identified with a wheelie bin symbol Two Categories of products covered by the WEEE Directive are currently exempt from the RoHS Directive Category 8 medical devices with the exception of implanted or infected pr...

Page 3: ...ear Panel 10 Air Cylinder Installation 11 Fuse Replacement 12 Operation Getting Started Turning Ventilator On 13 Main Operating Screens 14 Key Functions 15 Safe Range Respiratory Profiles 16 Entering Animal Weight 18 Starting and Stopping Ventilation 19 Displaying Ventilation Parameters 19 Warnings and Faults 20 Operation Respiration Profiles Entering Respiration Rate 22 Entering Tidal Volume 22 E...

Page 4: ...Remote Control Monitoring Serial Communications 33 Changing Air Cylinders 36 Hardware Setup 37 Diagnostics 39 Power Failure 44 General Maintenance and Cleaning 44 Appendices A General Specifications 45 B I O Specifications 46 C Serial Commands Queries and Responses 47 48 D Glossary of Terms 49 E Sample Waveforms 50 F Frequently Asked Questions 51 52 G Recommended Cylinder Size 53 H Recommended Por...

Page 5: ...ILITY OR FITNESS FOR A PARTICULAR USE OR OF ANY OTHER NATURE Some states do not allow this limitation on an implied warranty so the above limitation may not apply to you If a defect arises within the two year warranty period promptly contact Harvard Apparatus Inc 84 October Hill Road Building 7 Holliston Massachusetts 01746 1388 using our toll free number 1 800 272 2775 Goods will not be accepted ...

Page 6: ... Connections Make sure all connections are made properly and securely Any signal wire connec tions to the Inspira unit must be no longer than 3 meters Observe all Terminal Ratings Review the operating manual to learn the ratings on all Inspira connections Do Not Operate Without Cover Make sure that the top cover is securely in place before connecting to power source to avoid injury to body and dam...

Page 7: ...sly monitors the airway pressure to prevent over pressure conditions Most vol ume controlled ventilators presently available do not support sigh breaths and do not provide any pressure monitoring as a safety feature The Inspira ASVp pressure controlled ventilator adds pressure control capability to the ASVv volume controlled platform Inspiration pressure is limited to the user entered pressure set...

Page 8: ...olled mode the fre quency and pressure of the sigh breaths are selectable Respiratory Assist The Inspira ventilator supports Respiratory Assist in both volume and pressure con trolled modes This feature is used to wean an animal off the ventilator When the ani mal attempts to initiate a breath on its own a pressure sensor detects the drop in air way pressure This drop initiates a ventilation cycle...

Page 9: ...e Only connect to ground ed power receptacles to help ensure proper grounding do not use adapter plugs 6 Read the manual to become familiar with all features and functions of the Inspira Location Requirements A sturdy level clean nonflammable and dry surface Minimum of 1 inch 2 5 cm clearance around the pump Adequate power supply Room temperature 4 to 40 C 40 to 104 F Relative humidity of 20 to 80...

Page 10: ...ventilator Exhaust Flow of expired air from ventilator This gas may be vented to room recirculated for rebreathing collected and or filtered if chemicals are present in the expired air Figure 3 Airway Tubing Connections CAUTION Do not vent anesthesia gases to room air Source Flow of gas used by Inspira for inspira tion Connect to the source of inspira tion gas or leave disconnected to use room air...

Page 11: ...n cycle allowing synchronization of other electronic equipment with Inspira s respiration cycle Trigger In For use with equipment which uses a digital signal to start and stop respiration An example of this type of equipment would be a footswitch Analog Out 1 An analog signal representing the airway pressure within the ventilator This signal may be monitored with an oscilloscope Analog Out 2 Not u...

Page 12: ... 5 Signal Ground GND 6 No Connection 7 Request to Send Input RTS 2 8 No Connection 9 No Connection 1 Used for Vpp Enable in optional flash programming configuration disabled in hardware 2 Used as Serial Reset in optional flash programming configuration disabled in hardware RS232 Out Used to establish a daisy chain serial connection with other devices Future models will support a serial printer con...

Page 13: ...scharge ESD can damage compo nents on the circuit boards Avoid contact with the circuit boards when changing cylinders Figure 7 Air Cylinder Installation Procedure Before the Inspira can be used for the first time one of the two provided air cylinders 10 cc and 100 cc must be installed Choose the proper cylinder depending on the size of the animal to be ventilated Remove the top cover of the venti...

Page 14: ...e screwdriver to pry open the access door Remove the fuse holder and then remove the fuses from this holder as shown in figure 8 below Replace fuses using only 1 amp 250 volts Type T fuses Then replace the fuse holder Note A fuse which is not operator replaceable is located on the power supply This fuse is rated 5 amps 250 volts lead screw to the motor shaft Turn the lead screw until the flag pin ...

Page 15: ...old parameter keys in order to verify respiration parameters If any parameters need to be changed press the SET key and the appropriate parameter key and enter the value to set Press and release the RUN STOP key to start ventilation Pressure Controlled Ventilation Inspira ASVp Only With machine powered ON press and release the SELECT MODE key until PRES mode is selected Press SET andWEIGHT and ent...

Page 16: ...ing mode current operating variables such as tidal volume and respiration rate and the status of the ventilator stopped or running Main Operating Screen Pressure Control Mode Main Operating Screen Pressure Assist Control Mode Main Operating Screen Volume Control Mode Main Operating Screen Volume Assist Control Mode Paw Average Peak Pressure in cmH2O Vt Tidal Volume in cc Rate Respiration Rate in B...

Page 17: ...atio Pressure Displays Sets pressure limits RS232 Displays Sets current RS232 device s attached Set Keys Toggle Keys Data Entry Keys Figure 10 Front Panel Toggle Keys Pressing these keys toggle through the successive states of the key s function Run Stop Starts Stops the ventilator When stop ping the ventilator will finish its current stroke before ceasing ventilation Select Mode Toggles through a...

Page 18: ...d by the equation 0 0062 x Mb 1 01 where Mb is the animal mass in kilograms The respiratory rate in min 1 is determined by the equation 53 5 x Mb 0 26 The Safe Range is established by computing a range of acceptable values which are less than or equal to 10 of the calculated tidal volume and respiratory rate All the default parameter settings can be overridden If you enter a setting outside of the...

Page 19: ...g Started Ventilator Graph The graph labeled as figure 11 below shows tidal volume vs body mass and rate for labo ratory mammals in a resting state Apparatus dead space must be added Ventilation Parameters Mammals with 70g Body Mass Body Mass g Vt ml Rate BPM 15 0 1 159 20 0 12 148 30 0 18 133 40 0 24 123 50 0 30 117 60 0 36 111 70 0 42 107 ...

Page 20: ...et key The display should now read Press parameter key Press the Weight key The display will now read EnterWeight Kg Simply use the numeric keypad and decimal point key to enter the proper weight between 15 g and 10 kg The weight must be entered in kilograms Inspira will allow for the entry of up to three decimal places After entering the weight press the Enter key The display should read Change S...

Page 21: ...stopping Inspira will finish its current stroke before stopping completely The valve will always be in the expiration position when a STOP has been commanded Displaying Ventilator Parameters Inspira allows you to easily check the current ventilation parameters by using one key commands To display a specific parameter simply press and hold the appropriate key Key Display Operation Getting Started ...

Page 22: ... fault indicates that an overpressure condition has been detected in the airway The user is always notified via a visual alarm and also by an audible alarm if enabled An overpressure inVolume Control mode is defined as a pressure greater than the aver age measured peak pressure averaged over 10 samples not counting sigh breaths plus 10 cmH2O or 67cmH2O whichever is smaller This limit is adjusted d...

Page 23: ...rway For Volume Control mode an under pressure condition is defined as a pressure less than 25 of the average measured peak pressure averaged over 10 samples not count ing sigh breaths checked at a time approximately halfway into the inspiration stroke This could indicate that the airway is not connected or is leaking This is a critical fault and requires operator intervention The machine shall co...

Page 24: ...Enter key to enter the selected volume If the selected volume is not within the Safe Range a prompt will ask if you would like to override the Safe Range value see page 32 Entering Respiration Rate To enter a custom respiration rate press the Set key followed by the Rate key The dis play should now read Enter Resp Rate Enter the rate in breaths per minute BPM using the numeric keypad Only whole nu...

Page 25: ... read Enter Sigh Freq 1sigh __ breaths Again use the numeric keypad to enter the ratio of sigh breaths to regular breaths Note Inspira will only accept whole numbers for this ratio Press the Enter key to enter the selected ratio If the selected values are out of the Safe Range a prompt will ask you if you would like to override the Safe Range value see page 32 Operation Respiration Profiles Enteri...

Page 26: ...24 Harvard Apparatus Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Operation Respiration Profiles Sigh Pressure Pressure Control Mode Only Step Key Display ...

Page 27: ... I E ratio press the SET key followed by the I E RATIO key The dis play should now read Enter Inspiration 20 80 Use the numeric keypad to enter the whole number percentage of inspiration which must be between 20 and 80 The percent of expiration is determined from the value for inspiration Note Due to electro mechanical system limitations Inspira might not accept some I E Ratio values for certain r...

Page 28: ... the animal s lungs and user intervention is required immediately Ventilation will still occur after this threshold has been broken The default Inspiration Pressure is 35 cmH2O To set the inspiration pressure press the Set key followed by the Pressure key The display should now display a list of options Press 1 Insp 2 Asst Press the 1 on the numeric keypad to select the inspi ration pressure The d...

Page 29: ...will always use a negative assist pressure To set the assist pressure press the Set key followed by the Pressure key The display should now show a list of options Press 1 Insp 2 Asst Press 2 on the numeric key pad to select the assist pressure Now the display should read EnterAssist Pressure and also show the current assist pressure setting Use the numeric keypad to enter the vacu um pressure the ...

Page 30: ...d Safety Ventilator User s Manual Publication 5404 001 REV C Operation Respiration Profiles Step Key Display Entering Pressure Settings Inspira ASVp Inspiration Pressure Note 1 Sigh pressure setting only available in pressure control mode ...

Page 31: ...anual Publication 5404 001 REV C Operation Respiration Profiles Step Key Display Step Key Display PEEP Pressure Note 1 Sigh pressure setting only available in pressure control mode Note 1 Sigh pressure setting only available in pressure control mode Assist Pressure ...

Page 32: ...30 Harvard Apparatus Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Operation Respiration Profiles Step Key Display Sigh Pressure Pressure Control Mode Only ...

Page 33: ...cycle has occurred If the airway pressure is not reached within the inspiration time the machine will automatically adjust the inspira tory flow rate by incrementally increasing the tidal volume until the pressure limit is achieved If the pressure limit is reached early in the inspiratory cycle the machine will automatically decrease the flow rate so that the limit is reached toward the end of the...

Page 34: ...ptional signal is input by the user through the use of a footswitch or other device connected to the front panel BNC connector Minimum input pulse width 1 ms Sync Out Inspira ASVv version 1 13 and earlier This is an active low open collector digital signal generated at the start of each inspi ration stroke This signal is available at the front panel through a BNC connector The pulse width equals 2...

Page 35: ...e recommended cable length is 3 meters maximum Turn power off to Inspira and to the external device before connecting the cable into the connectors Check that the Inspira signal ground pin 5 is connected to the external device signal ground Use shielded cabling to connect Inspira s chassis ground to the chassis ground of the external device Serial Communication Setup To configure Inspira for seria...

Page 36: ...ud rates 38400 19200 9600 2400 and 1200 Pressing the Enter key will accept the valve and return Inspira to the main screen Default baud rate is 9600 Start Word and Stop Bit Configuration To change the bit configuration enter the port configuration menu by pressing 2 The display should read Define Serial Bits STRT WD STP and display the current bit settings respectively The start bit is fixed at 1 ...

Page 37: ...settings con nect the Inspira to the external device using the proper cable Send theVER command from the external device to Inspira If the RS232 connection is working properly the Inspira will return its version number If nothing is returned check the cable con nection and the port settings to verify that they are configured correctly Address Configuration Future Feature To assign an address to th...

Page 38: ...tracted cylinder back into the mounting groove which is found on the valve block Note When installing the air cylinder do not change the bends of the cylinder detection switches or else the correct cylinder will not be detected Now insert the new cylinder by placing the plunger portion of the air cylinder on the end of Inspira s white plunger Carefully slide the air cylinder back on the white plun...

Page 39: ...e hardware settings menu which is accessed by pressing the Set key followed by the Enter key Press Enter again to enter the hardware configuration menu Audible Alarm On Off To toggle the audible alarm on or off enter the hardware configuration menu Press 1 to enter the alarm setup The display should read Press Select Mode toToggle Alarm and display whether the alarm is currently on or off Pressing...

Page 40: ... indicates that the airway pressure ana log signal is connected to Analog Out 1 This is the only analog signal available in this model Inspira then returns to the main display screen Display Brightness Level To change the display brightness level enter the hardware configuration menu Press 3 to enter the display configuration The display should now read Set Brightness Level 100 default setting The...

Page 41: ... to perform the display test The display should read Display Test then illuminate all pixels and return to the diagnostics menu Keypad Diagnostics To run the keypad diagnostic enter the diagnostics menu Press 2 to start the key pad diagnostic The display should momentarily read KeypadTest Press Enter to Exit Then the display will show a cursor in its upper left hand corner This test echoes key str...

Page 42: ...The fault code is a hexadecimal code indicating faults and warnings detected since the fault log was last cleared The error count tracks the number of events which have occurred and caused the machine to re initialize The machine will re initialize automat ically three times before requiring user intervention Events such as valve stalls and end of travel faults trigger the automatic re initializat...

Page 43: ...tests Pressing 5 will return to the pre vious menu of tests Operation Advanced Step Key Display Clearing Fault Log To clear the information in the fault log press 2 The fault log will be cleared to 0x0000 but the error count will be retained Step Key Display Pressure Test Future Feature A pressure test for testing the internal pressure transducer is planned for future ver sions It is not yet imple...

Page 44: ...test The display should read Pump Test Once the test has completed suc cessfully the display will read Piston Test Success and return to the diagnostic menu Valve Diagnostics To check the respiration valve s functionality enter the diagnostics menu Press 4 and press 4 again to advance to the next menu of tests Press 2 to perform the valve test The display should read Valve Test Once the test has c...

Page 45: ...n Non Volatile Memory Diagnostics To check the non volatile memory NVRAM for errors enter the diagnostics menu Press 4 and press 4 again to advance to the next menu of tests Press 3 to per form the memory test The display should read No errors yet When done the dis play should read NVRAM test done and return to the diagnostic menu Step Key Display Step Key Display Returning to Previous Diagnostic ...

Page 46: ... will continue ventilation with the last entered respiratory parameters Harvard Apparatus recommends use of a UPS device or other backup power source when performing unmonitored ventilation Note There are many manufacturers of UPS devices Some examples are American Power Conversion www apc com and Belkin www belkin com Contact the UPS manufacturer for help in choosing the right sized unit General ...

Page 47: ...gh Sigh Pressure Full Range Insp Pressure to 50 cmH2O Safe Range Insp Pressure to Insp Pressure 10cmH2O or 35cmH2O whichever is less Respiratory Assist Available Assist Trigger 1 to 10 cmH2O Default 5 cmH2O Signal Inputs External Trigger Input 0 to 5 V digital pulse active low Signal Outputs Sync Out ASVv 0 to 5 V digital pulse 20 10 ms wide active low Sync Out ASVp V0H for Inspiration Duration V0...

Page 48: ...e Width 20 ms 10 ms Inspira ASVv Only Pulse Width Inspira ASVp V0H for Inspiration Duration V0L for Expiration Duration Protection Short Circuit Duration Indefinite ESD Protected Connector Type BNC Cable Length 3 m max Trigger In Signal Type Digital Input Input pulled up to 5 V through a 330 Ω resistor Drive with open collector or switch closure VIH min 2 4 V VIH max 7 V VIL max 0 8 V IIL typical ...

Page 49: ...d control exit remote mode RUN Start ventilation STP Stop ventilation SIGH Commands SIGH Breath OVRD Override Safe Range checking SAFE Enable Safe Range checking Commands with Input Data Format command data cr Response cr lf prompt SETRAT nnn Sets respiration rate in BPM breaths per min SETVOL nnn nn Sets tidal volume in cc SETIE nn Sets I E Ratio as inspiration SETSTV nnn nn Sets sigh tidal volum...

Page 50: ... of precision VER Return model ASVv ASVp ARV and firmware version number AIRPRS Returns airway pressure in cmH2O FLT Returns a 2 digit fault code xx defined as follows 00 No Fault 01 Overpressure 02 Under pressure 03 Motor Drive Fault 04 Pump Stall 05 Valve Stall Queries Inspira ASVp Only Format query cr Response cr lf value cr lf prompt Value is a string of characters of varying length PRS Return...

Page 51: ...tio of 1 1 is equivalent to 50 inspiration time An I E Ratio of 1 4 is equivalent to 20 inspi ration time Inspiration The process of breathing in inhaling a gas or gases Inspiration Pressure The pressure to which the subject s lungs are inflated during inspiration PEEP Positive End Expiratory Pressure Residual Volume The smallest volume to which the subject s lungs can slowly be deflated Respirati...

Page 52: ...s Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Appendix E Sample Waveforms Figure 13 Sample Waveforms A Patient triggered breath B Machine triggered breath due to no detected patient effort ...

Page 53: ...cc cylinder is not being detected first make sure that the rear most actuator arm is resting against the side of the cylinder If it isn t just reposition the actuator arm Next make sure that the switches are actu ating Gently pull back on the actuator arm s contacting the installed cylinder and listen for a click If the switch clicks it had not been actuated This indicates that the actuator arm s ...

Page 54: ...h a vaporizer and pressurized gasses When using anesthetic gasses keep in mind that total system volume will impact delay times in getting a change in gas mixtures to the animal Vent or scrub expired gasses do not vent to room air WARNING Do not vent anesthetic gasses to room air 7 How do I use the Inspira with MRI equipment Since the Inspira has a ferrous metal chassis and components it will be a...

Page 55: ...53 Harvard Apparatus Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Appendix G ...

Page 56: ...54 Harvard Apparatus Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Appendix H ...

Page 57: ...S Notes 1 Set flow rate into vaporizer per manufacturer s specification 2 Flow into breathing bag should be equal to or slightly greater than flow out of bag Gas pressure must be equalized with atmospheric pressure before drawing into ventilator An optional bleed circuit may be used to prevent pressurization of breathing bag Anesthesia Connection Kit Catalog No 73 3076 ...

Page 58: ...56 Harvard Apparatus Inspira Advanced Safety Ventilator User s Manual Publication 5404 001 REV C Appendix J Generating PEEP with Inspira ASVv ...

Page 59: ...is declared EN61010 EN61326 1998 Class B Manufacturer s Name Harvard Apparatus Inc Manufacturer s Address 84 October Hill Road Holliston Massachusetts 01746 U S A Type of Equipment Animal Ventilator Model No Inspira ASV I the undersigned hereby declare that the equipment specified above conforms to the above Directive s and Standard s Place United States of America Date July 11 2000 ...

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