Harvard Apparatus Inspira ASV MA1 55-7058 User Manual

Advanced safety ventilator

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Advanced Safety Ventilator
Inspira Advanced Safety Ventilator,
Volume Controlled
Inspira Advanced Safety Ventilator,
Pressure Controlled
Harvard Inspira
User's Manual
MA1 55-7058
MA1 55-7059
Publication 5404-001-REV-C

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Summary of Contents for Harvard Apparatus Inspira ASV MA1 55-7058

  • Page 1 Harvard Inspira Advanced Safety Ventilator User's Manual Inspira Advanced Safety Ventilator, Volume Controlled MA1 55-7058 Inspira Advanced Safety Ventilator, Pressure Controlled MA1 55-7059 Publication 5404-001-REV-C...
  • Page 2 WEEE/RoHS Compliance Statement EU Directives WEEE and RoHS To Our Valued Customers: We are committed to being a good corporate citizen. As part of that commitment, we strive to maintain an environmentally conscious manufacturing operation. The European Union (EU) has enacted two Directives, the first on product recycling (Waste Electrical and Electronic Equipment, WEEE) and the second limiting the use of certain substances (Restriction on the use of Hazardous Substances, RoHS).
  • Page 3: Table Of Contents

    Table of Contents SUBJECT PAGE NO. Warranty and Repair Information ............3 General Safety Summary ..............4 Introduction: Theory of Operation ..............5 Features ..................5 Installation: Initial Setup and Location Requirements ........7 Typical Operation ................7 Ventilator Connections: Airway Tubing Connections: Front Panel ......8 Electrical Connections: Front Panel ........9 Electrical Connections: Rear Panel........10 Air Cylinder Installation ..............11...
  • Page 4 Table of Contents SUBJECT PAGE NO. PEEP Pressure ................29 Sigh Pressure ................30 Modes of Operation: Volume Mode ................31 Pressure Mode ................31 Assist Mode................31 Operation: Advanced: User Override................32 Using Digital and Analog I/O Ports ..........32 Remote Control/Monitoring (Serial Communications)....33 Changing Air Cylinders ............36 Hardware Setup................37 Diagnostics ..................39 Power Failure ................44...
  • Page 5: Warranty And Repair Information

    Harvard Apparatus warranties this instrument for a period of two years from date of purchase.At its option, Harvard Apparatus will repair or replace the unit if it is found to be defective as to workmanship or materials.This warranty does not extend to dam- age resulting from misuse, neglect or abuse, normal wear and tear, or accident.
  • Page 6: General Safety Summary

    General Safety Summary Please read the following safety precautions to ensure proper use of your Inspira ven- tilator. To avoid potential hazards and product damage, use this product only as instructed in this manual. TO PREVENT HAZARD OR INJURY: Use Proper Line Cord Use only the specified line cord for this product and make sure line cord is certified for country of use.
  • Page 7: Introduction

    Introduction Figure 1. Front view of Figure 2. Rear view of Inspira Advanced Safety Ventilator Inspira Advanced Safety Ventilator Theory of Operation The Inspira is Harvard’s first ventilator that can ventilate animals from mice to cats using the same machine. Its versatility and ease of use allow safer and superior ven- tilation.The Inspira Ventilator uses an advanced piston/cylinder assembly and a micro- processor controlled actuation mechanism to precisely control respiration profiles.
  • Page 8 Introduction Pressure Control Mode (Inspira ASVp Only) The ventilator delivers gas to the patient until the user-selected pressure limit is reached. Flow rate is automatically adjusted by the machine so that the pressure limit is reached near the end of the inspiration time. Respiration frequency and I:E Ratio determine the amount of time for inspiration and expiration phases.
  • Page 9: Installation

    Installation Initial Setup 1. Remove unit from box. 2. Remove foam-packing inserts from both ends of the ventilator. 3. Locate and carefully remove air cylinders and power cord from shipping material. 4. Visually inspect both the ventilator and the air cylinders for any damage that might have occurred in the shipping process.
  • Page 10: Ventilator Connections

    Installation VENTILATOR CONNECTIONS The Inspira ASV comes with connection ports located on the front and rear panels of the ventilator. These connections are shown on the following pages. Airway Tubing Connections: Front Panel The Inspira ASV provides four airway-tub- ing connections at the front of the machine.
  • Page 11: Electrical Connections: Front Panel

    Installation Figure 4. Front Panel Electrical Connections: Front Panel Inspira provides four BNC type connectors at the front of the machine. Their func- tions are as follows: Sync Out Produces a digital pulse at the start of the respiration cycle allowing synchronization of other electronic equipment with Inspira’s respiration cycle.
  • Page 12: Electrical Connections: Rear Panel

    Installation Electrical Connections: Rear Panel Inspira provides power entry, RS232 com- munications, and User I/O (Optional) con- nections at the rear of the machine. Their functions are as follows: User I/O Not used in this model. RS232 In For use with a host computer to establish a communication connection between the Figure 5.
  • Page 13: Air Cylinder Installation

    Figure 7.Air Cylinder Installation Air Cylinder Installation Key Information 1. Use ONLY Harvard Apparatus approved air cylinders. Any other non- approved cylinders may damage the Inspira unit. 2. Do not oil or grease the air cylinders. Inspira’s special air cylinders are self- lubricating, requiring no additional lubrication.Applying oil or grease may...
  • Page 14: Fuse Replacement

    2. Use only Type 3AG, 1/4” x 11/4”, 1 amp, 250 volt,Type T (time delay) fuses (Harvard Apparatus part number 5113-033 or equivalent). Turn off power and remove power cord from power module. Use a straight blade screwdriver to pry open the access door.
  • Page 15: Turning Ventilator On

    Operation: Getting Started Figure 9. Main Operating Screen, Volume-Control Mode Turning Ventilator On Power must be properly supplied to the ventilator, according to the power specifica- tions. Locate the power switch on the rear of the ventilator. Toggle the switch so that the “I”...
  • Page 16: Main Operating Screens

    Operation: Getting Started Main Operating Screens The main operating screen is the default display. This screen displays the operating 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 –...
  • Page 17: Key Functions

    Operation: Getting Started Set Keys Toggle Keys Data Entry Keys Figure 10. Front Panel Set Keys Toggle Keys Pressing these keys toggle through the successive states of the key’s function. Allows modification of a data item. To modify a data item, press the relevant key Run/Stop after pressing the [Set] key.
  • Page 18: Safe Range Respiratory Profiles

    Operation: Getting Started Safe Range ™ Respiratory Profiles Setting up the ASV ventilator is both easy and safe thanks to the Safe Range ™ software. Once the animal’s body weight has been entered the software computes the median settings for tidal volume and respiratory rate.These same equations are used to cal- culate a Safe Range ™...
  • Page 19 Operation: Getting 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.) Figure 11.Ventilator Graph Ventilation Parameters Mammals with < 70g Body Mass Body Mass (g) Vt (ml) Rate (BPM)
  • Page 20: Entering Animal Weight

    Operation: Getting Started Entering Animal Weight Key Information • The Inspira can handle animal weights ranging from 0.015 to 10.00 kilo- grams. • The large cylinder can handle masses between 0.160 and 10.00 kilograms and the small cylinder can handle masses between 0.015 and 0.59 kilograms. •...
  • Page 21: Starting And Stopping Ventilation

    Operation: Getting Started Starting and Stopping Ventilation To start and stop ventilation simply press the [Run/Stop] key. When 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.
  • Page 22: Warnings And Faults

    Operation: Getting Started Warnings and Faults Pump Stall This fault indicates that the expected motion of the piston axis does not match the actual motion. This is a critical fault and requires operator intervention.The valve is set to the expiration position and the machine is commanded to STOP. The user is always notified via a visual alarm and also by an audible alarm (if enabled).
  • Page 23 Operation: Getting Started Occlusion Alarm (Inspira ASV p Only) If the peak pressure limit is reached within the first 40% of the inspiration stroke, an occlusion alarm is reported. This indicates that a restriction may be present in the air- way or that the airway resistance may be too high for the flow rate.
  • Page 24: Entering Respiration Rate

    Operation: Respiration Profiles 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 numbers will be accepted as valid rates. Press the [Enter] key to enter the selected rate.
  • Page 25: Entering Sigh Breath

    Operation: Respiration Profiles Entering Sigh Breath (Volume-control Mode) • A sigh tidal volume (STv) and a sigh frequency must be set in order to acti- vate the sigh breath function in volume-control mode. To enter a sigh tidal volume and a sigh frequency press the [Set] key followed by the [Sigh] key.
  • Page 26 Operation: Respiration Profiles Sigh Pressure (Pressure-Control Mode Only) Step Display Publication 5404-001-REV-C...
  • Page 27: Entering I:e Ratio

    Operation: Respiration Profiles Entering I:E Ratio • The I:E ratio is the ratio of the time needed for inhalation compared to time needed for exhalation.The volume of the inhalation breath is always the same as the volume of the exhalation breath. •...
  • Page 28: Entering Pressure Settings (Inspira Asvv)

    Operation: Respiration Profiles Entering Pressure Settings (Inspira ASV v ) Inspiration Pressure The Inspiration pressure is a pressure threshold, which is used to detect airway over- pressure conditions. If the average airway pressure rises above this pressure thresh- old, an alarm is sounded (if enabled) and the display shows the fault.This indicates that the residual volume may be increasing in the animal’s lungs and user intervention is required immediately.
  • Page 29: Assist Pressure

    Operation: Respiration Profiles Assist Pressure The assist pressure is a sub-baseline pressure threshold which is used to trigger an inspi- ration stroke. Inspira looks for this trigger within the first 10% of the calculated inspira- tion time, which is determined by the inspiration rate. The default Assist Pressure is -5 cmH 2 O.
  • Page 30: Entering Pressure Settings (Inspira Asvp): Inspiration Pressure

    Operation: Respiration Profiles Entering Pressure Settings (Inspira ASVp) Inspiration Pressure Step Display Note 1: Sigh pressure setting only available in pressure-control mode. Publication 5404-001-REV-C...
  • Page 31: Assist Pressure

    Operation: Respiration Profiles Assist Pressure Step Display Note 1: Sigh pressure setting only available in pressure-control mode. PEEP Pressure Step Display Note 1: Sigh pressure setting only available in pressure-control mode. Publication 5404-001-REV-C...
  • Page 32: Sigh Pressure

    Operation: Respiration Profiles Sigh Pressure (Pressure-Control Mode Only) Step Display Publication 5404-001-REV-C...
  • Page 33: Volume Mode

    Operation: Respiration Profiles Operating Modes The Inspira ASV has two operating modes, Volume Mode and Assist Mode.To toggle between the modes press the [Select Mode] key. The upper right hand corner of the display will show which mode the ventilator is currently in, either VOL or ASST. The Inspira ASVp has four operating modes –...
  • Page 34: User Override

    Operation: Advanced User Override The user has the option of overriding the machine’s “Safe Range ™ ” limits to allow for more advanced respiratory control. The Safe Range™ is defined as ±10% of the machine's recommended tidal volume and ±10% of the machine’s recommended respi- ration rate.
  • Page 35: Remote Control/Monitoring (Serial Communications)

    Remote Control / Monitoring (Serial Communication) The Inspira is equipped for serial communication through two RS232 ports. Inspira uses a Harvard Apparatus Command Line protocol as the basis of its serial commands. These serial commands can be found in Appendix C.
  • Page 36 Operation: Advanced Data Transfer Rate Configuration To configure the data transfer rate, enter the port configuration menu. Press [1] to enter the Baud rate setup screen. The display should read “Press Select Mode to tog- gle baud”and display current baud rate. Press the [Select Mode] key to toggle through the baud rates (38400, 19200, 9600, 2400, and 1200).
  • Page 37 Operation: Advanced Parity Configuration To configure the port parity settings, enter the port configuration menu. Press [3] to enter the parity configuration menu. The display should read “Define Parity: 1= Even, 2= Odd, 3= None”. Choose the desired parity by pressing the corresponding numer- ic key.
  • Page 38: Changing Air Cylinders

    Operation: Advanced Changing Air Cylinders The Inspira ventilators use two easily interchangeable piston/cylinder assemblies. These assemblies are available to provide 0.1 to 10 ml and 1 to 100 ml tidal volumes. Changing the piston/cylinder assembly is simple. Remove the top cover of the venti- lator by removing the seven phillips head screws which hold the top cover in place.
  • Page 39: Hardware Setup

    Operation: Advanced Hardware Setup Inspira’s microprocessor based system provides hardware setup options and diagnos- tic tests to be run on the ventilator. Hardware setup menus allow the user to config- ure specific hardware in the ventilator, while the diagnostics provide some tests to help in troubleshooting faults.
  • Page 40 Operation: Advanced I/O Setup To review or modify the I/O settings, enter the hardware configuration menu. Press [2] to enter the I/O setup. The display should now read “Set I/O: Press 1= Digital, 2= Analog”. Pressing [1] selects Digital I/O configuration. This feature is a future option and is not presently available.
  • Page 41: Diagnostics

    Operation: Advanced Diagnostics To enter the Inspira diagnostic menu, first enter the hardware configuration menu and press [4] to advance to the next menu. The display should read “Press 5= Diagnostics”. Press [5] to enter the diagnostics menu. The display should read “Press 1= Dsply, 2=Key, 3=Alarm, 4=Next”.
  • Page 42 Operation: Advanced Audible Alarm Diagnostics To test the audible alarm, enter the diagnostics menu. Press [3] to perform the alarm test. The display should read “Press set to test, Press enter to exit”. Press the [Set] key to sound the alarm. When finished press the [Enter] key to return to the diagnostics menu.
  • Page 43 Operation: Advanced 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* Display Pressure Test (Future Feature) A pressure test for testing the internal pressure transducer is planned for future ver- sions.
  • Page 44 Operation: Advanced Pump Diagnostics To check the pumping mechanism functionality,enter the diagnostics menu. Press [4] and press [4] again to advance to the next menu of tests. Press [1] to perform the pump 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.
  • Page 45 Operation: Advanced 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.
  • Page 46: Power Failure

    When the power is restored,the machine will power up in its last commanded state. If that state was RUN, it 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.
  • Page 47: General Specifications

    Appendix A General Specifications Specifications Animal Size 15 g to 10 kg Volume 0.1 to 100 ml Port Sizes 1/8”-27 NPT threaded nylon barbed ports, accommodates 1/16”, 1/8”, 3/16” ID Tubing (Default = 1/8” ID Tubing) Control Modes Volume or Assist Breathing Rate 5 to 200 bpm Resolution...
  • Page 48: I/O Specifications

    Appendix B I/O Specifications Specifications Analog Out 1, Analog Out 2: Signal Type Analog Output V OH (max) +10.5 V @ R L = 1 M V OL (typical) V OL (max) 50 mV @ I OL = 0 I OUT 0.5 mA @ V O = 5V, R L = 10 K I OUT (max) 30 mA...
  • Page 49: Serial Commands, Queries And Responses

    Appendix C SERIAL COMMANDS, QUERIES, AND RESPONSES Each command sent to the Inspira is a string of ASCII characters. Commands are not case sensitive and spaces are optional. After a transmission to the Inspira terminating with a <cr> character, the Inspira enters remote mode and responds with the three character sequence: <cr><lf>prompt <cr>...
  • Page 50 Appendix C SETPEEP Sets PEEP pressure in cmH 2 O SELMOD mode Selects operation mode (mode = VOL,VOLASST, PRES, or PRESASST) Queries Format: query<cr> Response: <cr><lf>value<cr><lf>prompt Return respiration rate in BPM (breaths per min) as integer value Return tidal volume in cc to 2 decimal places Return I:E Ratio as % inspiration Return Sigh Tidal Volume in cc to 2 decimal places SFREQ...
  • Page 51: Glossary Of Terms

    Appendix D Glossary of Terms Assist Respiratory assist mode, whereby a subject is aided in regaining normal breathing after artificial respiration (weaning), or for respiration of a non-paralyzed, anesthetized sub- ject. Ventilation is triggered when the device detects a slight vacuum in the airway. Expiration The process of breathing out (exhaling) a gas or gasses.
  • Page 52: Sample Waveforms

    Appendix E Sample Waveforms A Patient-triggered breath B Machine-triggered breath due to no detected patient effort Figure 13. Sample Waveforms Publication 5404-001-REV-C...
  • Page 53: Frequently Asked Questions

    Appendix F Frequently Asked Questions 1. When I start ventilation, why is underpressure constantly displayed? If no connection is made to the "To Animal" port, this is the proper indication. The fault will clear when airway pressure is detected. If proper connections have been made, there is most likely a leak in the system. Make sure that the O-ring has been installed properly before installing the glass cylinder.
  • Page 54 Appendix F ratory parameters. 4. How do I create a PEEP pressure with the Inspira ASVv? To create a PEEP pressure when using the Inspira ASVv, simply connect a length of tubing to the "Exhaust" port and submerge the other end in a column of water. The depth of the end of the tubing (in cm) below the water surface will give the PEEP pressure in cmH 2 O.
  • Page 55: Recommended Cylinder Size

    Appendix G Publication 5404-001-REV-C...
  • Page 56: Recommended Port Size

    Appendix H Publication 5404-001-REV-C...
  • Page 57: Using Inspira With Pressurized And Anesthetic Gasses

    Appendix I Using Inspira with Pressurized and/or Anesthetic Gasses GASSES 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.
  • Page 58: Generating Peep With Inspira Asvv

    Appendix J Generating PEEP with Inspira ASV v Publication 5404-001-REV-C...
  • Page 59 Declaration of Conformity Application of Council Directive(s): 73/23/EEC, 89/336/EEC Standard(s) to which conformity 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.:...

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