Michigan Instruments LIFE-STAT 1008MII Instructions For Use Manual
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Michigan Instruments LIFE-STAT 1008MII Instructions For Use Manual

Mechanical cpr system
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Model 1008
MII
Mechanical CPR System
Instructions for Use (IFU) Manual
h
(Part Number
16005)
Manufactured in the USA by:
4717 Talon Court SE
Grand Rapids, MI 49512 USA
Tel: (800) 530-9939 or (616) 554-9696
Fax: (616) 554-3067
e-mail:
mii@michiganinstruments.com
website:
www.life-stat.com
REV: 2019-04
1

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  • Page 1 Model 1008 Mechanical CPR System Instructions for Use (IFU) Manual (Part Number 16005) Manufactured in the USA by: 4717 Talon Court SE Grand Rapids, MI 49512 USA Tel: (800) 530-9939 or (616) 554-9696 Fax: (616) 554-3067 e-mail: mii@michiganinstruments.com website: www.life-stat.com REV: 2019-04...
  • Page 2 Copyright PROTECTED UNDER ONE Copyright © OR MORE OF THE FOLLOWING U.S. PATENTS: 6,171,267 5,743,864 Michigan Instruments 4717 Talon Court SE Grand Rapids, MI 49512 All rights reserved Symbols used on the device and in this IFU: Symbol Meaning Symbol Meaning Manufacturer –...

  • Page 3: Table Of Contents

    Contents 1-Introduction ..................................5 ® 1.1 The Life-Stat Model 1008 Instructions for Use (IFU) ....................5 1.2 Use of Warnings, Cautions, and Notes .......................... 5 1.3 Indication for Use ................................6 1.4 Contraindication................................6 1.5 Benefits of Mechanical CPR ............................6 1.6 General Warnings and Cautions ............................
  • Page 4 5.6 Mobile Oxygen Carrier (MOC) ........................... 31 5.7 Periodic Preventive Maintenance..........................31 5.8 Shift Check .................................. 33 5.9 Functional Check ................................. 35 5.10 Troubleshooting Guide: ............................. 37 ® 5.11 Life-Stat Model 1008 Detailed Specifications ...................... 38 5.12 Electromagnetic Environmental Declaration......................39 ®...

  • Page 5: 1-Introduction

    1-Introduction Federal law restricts this device to sales to, or on the order of, a licensed medical practitioner. ® 1.1 The Life-Stat Model 1008 Instructions for Use (IFU) NOTE: The purpose of this manual is to explain the use, care, and user maintenance of the device, not to teach cardiopulmonary resuscitation.

  • Page 6: Indication For Use

    1.3 Indication for Use ® The Life-Stat CPR System is used to perform Cardiopulmonary Resuscitation (CPR) on adult patients only in cases of clinical death, as defined by a lack of spontaneous breathing and pulse. ® WARNING: The Life-Stat is to be used solely for the purpose of delivering mechanical cardiopulmonary resuscitation (CPR) in accordance with established American Heart Association (AHA) guidelines.

  • Page 7: General Warnings And Cautions

    1.6 General Warnings and Cautions WARNING: Improper application of this equipment can cause serious injury. This manual must be thoroughly understood in order to use this device correctly and to avoid possible serious injury. WARNING: Federal law restricts this device to sales to, or on the order of, a licensed medical practitioner.
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  • Page 9: 2-Product Description

    2-Product Description ® 2.1 Life-Stat Cardiopulmonary Resuscitator ® The Michigan Instruments Life-Stat is the latest model of our portable, automatic cardiopulmonary resuscitation (CPR) medical devices which have been in use since 1964. 2.2 General Description ® The Life-Stat system provides consistent CPR support for cardiac arrest patients under conditions ®...

  • Page 10: Life-Stat ® System

    ® 2.3.1 Life-Stat System The Arm and Column positions the Piston and Massager Pad correctly over the patient’s sternum. It is designed to provide a sternal deflection percentage based on the patient A-P chest diameter. Sternal deflection is nominally set to 20% of the A-P diameter. The depth of each chest compression is easily monitored using the markings on the Dome surrounding the Piston.

  • Page 11: Controls And Labeling

    2.3.2 Controls and Labeling ® The Life-Stat controls are located on the back of the Arm. Control Panel ® 1. SYSTEM CONTROL (Control#1): This membrane keypad is used to control the Life-Stat . It is comprised of 5 electronic buttons, described below. START/ON button.
  • Page 12 2. COMPRESSION DEPTH (Control #2): This control is used for setting the depth of compression on the patient. The depth is set to correspond to the measured A-P diameter shown on the scale located on the back of the Column. As indicated by the arrow, turn the knob clockwise to increase the compression depth and counterclockwise to decrease compression depth.

  • Page 13: Battery Power Supply

    2.3.3 Battery Power Supply ® The Life-Stat electronic control module is powered by two (2) 9V alkaline batteries. CAUTION: Do NOT use excessive force to install the battery in the tray. Ensure the polarity is oriented per the label and to the diagram embossed on the bottom of the tray (+ on left, - on right).

  • Page 14: Important Safety Features

    • If stored for extended periods with batteries installed, inspect both batteries prior to use to ensure they have not corroded. • Dispose of used batteries properly. 2.4 Important Safety Features Changing a battery during operation -- Should a low battery level occur during resuscitation efforts, either battery may be removed and replaced, (one at a time), from its compartment and a fresh battery can be “hot swapped’...

  • Page 15: The Backboard

    2.5 The BackBoard The BackBoard is intended for either manual or mechanical CPR. It is designed to provide a firm, non-rebounding surface upon which CPR can be performed, and introduces a slight hyperextension of the patient’s neck to facilitate upper airway management. It allows use of the Life-Stat ®...

  • Page 16: The Carrying/Storage Case

    Single tank carrier for “DD” carbon fiber cylinder (Regulator available separately) Dual tank carrier for “D” or “E” aluminum cylinders (Cylinders not included) Mobile Oxygen Carrier (MOC) 2.7 The Carrying/Storage Case ® The Carrying/Storage Case is constructed of a durable nylon. The Life-Stat Supply Hose and code-related supplies are stored in the Case in a manner which permits immediate access to the device and facilitates easy setup at an emergency site.

  • Page 17: 3-Setup And Operation

    3-Setup and Operation 3.1 Precautions ® Before setting up and using the Life-Stat , there are several important precautions that must be observed at all times. ® 1. The Life-Stat must only be used in cases of clinical death as defined by lack of spontaneous breathing and pulse.

  • Page 18: Recommendations

    3.2 Recommendations ® It is recommended that the Arm/Column of the Life-Stat be attached to the Base while stored in the Carrying/Storage Case. Additionally, the Arm should be positioned over the Base so that it is perpendicular to the O Supply Connector located at the bottom of the Column.

  • Page 19: Positioning The Patient

    3.3 Positioning the Patient The following steps are provided as a recommendation. 1. When applying the BackBoard, “Log roll” the patient into position, taking care to keep the cervical spine immobilized. WARNING: When moving a patient in cases of suspected C-spine injury, always support the patient’s head in a neutral position.

  • Page 20: Life-Stat Deployment

    ® 3.4 Life-Stat Deployment ® 3.4.1 Life-Stat Setup: ® A. Remove the Life-Stat from the Case. Press for B. Ensure the System C. Ensure Controls (#2) & Control (#1) is OFF. (#3) are both turned fully counterclockwise. D. Attach the Breathing Hose/Non Re-breathing valve (and mask, if used) to the PDV.

  • Page 21: Life-Stat ® Application To The Patient

    ® CAUTION: The Life-Stat requires a medical grade Oxygen source capable of delivering pressure from 50 to 90 psi (3.515 to 6.327 kgf/cm ), with a minimum flow rate of at least 45 LPM. Always follow safe Oxygen handling practices with Oxygen cylinders and regulators.

  • Page 22: Determine Compression Depth

    WARNING: Injury to patient may occur if Arm is adjusted too low, as indicated by the top of the Piston moving up beyond “-” on the Dome. WARNING: Patient chest compressions may be insufficient to be effective if Arm is adjusted too high as indicated by the top of the Piston not moving up to “-”...
  • Page 23 WARNING: Failure to ensure that the VENTILATION VOLUME knob (Control #3) is turned fully counterclockwise upon initial application to the patient and prior to selecting a CPR mode via the SYSTEM CONTROL #1 will deliver ventilations to the patient (if the breathing hose is applied to the patient) at the tidal volume last set by Control #3.

  • Page 24: Life-Stat ® Ventilator- Patient Demand Valve (Pdv) Activation

    ® 3.4.5 Life-Stat Ventilator- Patient Demand Valve (PDV) Activation: A. Rotate the VENTILATION VOLUME knob (#3) clockwise in accordance with AHA guidelines, and/or local protocol to desired volume (mL). B. Apply the Breathing Hose/Non Re-breathing Valve to the patient via mask or ET tube. C.

  • Page 25: Procedure To Interrupt (Suspend) Compressions

    3.4.6 Procedure to Interrupt (Suspend) Compressions: To perform pulse checks or perform analysis with an AED (and/or defibrillate manually), simply press the PAUSE button. This will interrupt compressions only, while ventilations continue at the previous rate and volume setting. To resume compressions, press the desired mode button (30:2 or CCV). The same depth of compression previously set by the COMPRESSION DEPTH knob will be delivered.
  • Page 26 F. Loosen the Arm Lock Lever and raise the Arm on the Column high enough to clear the patient. Tighten the Arm Lock Lever. ® G. Remove the Life-Stat from the BackBoard. ® H. Clean and inspect the Life-Stat per the recommended Shift Check (Daily or after each use). WARNING: The Breathing Hose (h 14669) and Non Re- breathing Valve (h 14384) supplied with the device is intended for single use only.

  • Page 27: 4-Storage And Shipping

    ® If the Life-Stat must be shipped for any reason, a factory carton with protective foam inserts is recommended to protect the device. Replacement cartons are available from Michigan Instruments. ® CAUTION: Do not ship the Life-Stat in the Carrying/...
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  • Page 29: 5-Care, Cleaning, And Disinfection

    5-Care, Cleaning, and Disinfection ® NOTE: This section comprises the extent of serviceable items for the Life-Stat NO SERVICE, REPAIR or MAINTENANCE other than what is explained in this section should be performed by the user. Any service, repair or maintenance not listed in this section is to be PERFORMED ONLY by FACTORY AUTHORIZED SERVICE PERSONNEL.
  • Page 30 5.5 Cleaning and Disinfecting the Patient Demand Valve A. Remove the Hose Adaptor, Lip Valve and Pressure Hose Limit Alarm from the Patient Demand Valve (PDV). Adaptor B. Using a small soft bristle brush, clean all foreign matter from the components with a mild soap solution. Rinse the parts thoroughly in clean water.

  • Page 31: Mobile Oxygen Carrier (Moc)

    5.6 Mobile Oxygen Carrier (MOC) • Should you require maintenance of the regulator(s) used in the MOC, contact the manufacturer of the regulator to arrange for service. Vendor information is provided with the MOC regulator at the time of purchase. •...
  • Page 32 Factory-Recommended Maintenance/Service Intervals Factory ® Life-Stat Shift Check Functional Check Service Heavy use: Daily After each use Monthly Every 2 years Frequent use: 10 - 15 times per month After each use Quarterly Every 3 - 4 years Infrequent use: < 10 times per month After each use Semi annually Every 5...

  • Page 33: Shift Check

    5.8 Shift Check Procedure: A. Visual inspection Make sure that the device and all accessories are clean and free of any contaminants. Check the device and all accessories for any worn, loose or damaged parts. Discard any used Breathing Hose (and Non Re-breathing Valve, if single use). Clean and disinfect the PDV components if necessary.
  • Page 34 ® Shift Check of Life-Stat (Daily, or after each use) Date: ____/____/____ Shift: ___________ Location: __________ Serial Number:__________ At the beginning of each shift, inspect the device. Indicate whether all requirements have been met. Note any corrective actions taken. Sign the form. Requirement Acceptable Corrective Action/Remarks...

  • Page 35: Functional Check

    5.9 Functional Check Procedure: A. Visual and Mechanical Inspection Appearance (Check the overall appearance and condition of the device.) Make sure the device and all accessories are clean and free of any contaminants. Check the device and all accessories for any worn, loose or damaged parts (refer to Cautions: listed in the Shift Check section). ®...
  • Page 36 ® Functional Check of Life-Stat (Weekly, monthly, or per determined schedule) Date: ____/____/____ Shift: ___________ Location: __________ Serial Number:__________ Per the determined schedule, inspect the device. Indicate whether all requirements have been met. Note any corrective actions taken. Sign the form. Acceptable Requirement Corrective Action/Remarks...

  • Page 37: Troubleshooting Guide

    Should the device fail to operate properly at any time refer to the following Troubleshooting Guide. Disconnect the ventilator from the patient any time the unit does not appear to be operating properly. If unable to determine the cause of problem, contact Michigan Instruments for service. Indication...

  • Page 38: Life-Stat Model 1008 Detailed Specifications

    ® 5.11 Life-Stat Model 1008 Detailed Specifications Input: - Compressed O at 50 to 90 psi (3.515 to 6.327 kgf/cm - Gas Consumption (average)*: in 30:2 mode- 34 L/min (8.98 gal/min) @100 CPM**, 70 L/min (11.62 gal/min) @120 CPM*** in CCV mode- 44 L/min (11.62 gal/min) @100 CPM**, 134 L/min (35.4 gal/min) @120 CPM*** - Indicator to show adequate input pressure: 50 ...

  • Page 39: Electromagnetic Environmental Declaration

    5.12 Electromagnetic Environmental Declaration NOTE: The Life-Stat is powered by 9V DC batteries and does not use a Public Mains Power Network. Guidance and manufacturer’s declaration- electromagnetic emissions The Life-Stat is intended for use in the electromagnetic environment specified below. The customer or the user of the Life-Stat should assure that it is used in such an environment.
  • Page 40 Guidance and manufacturer’s declaration- electromagnetic immunity The Life-Stat is intended for use in the electromagnetic environment specified below. The customer or the user of the Life-Stat should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment-guidance level...
  • Page 41 Recommended separation distances between portable and mobile RF communications equipment and the Life-Stat The Life-Stat is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Life-Stat can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Life-Stat as recommended below, according to the maximum output power of the communications equipment.

  • Page 42: Parts List (Life-Stat ® )

    ® 5.13 Parts List (Life-Stat Part No. Description Resuscitation ® 16000Y Life-Stat Model 1008 (Yellow) 14790-01 BackBoard 15450 CPR Carrying Case- Backpack Replacement Parts 16005 Life-Stat ® Instructions for Use (IFU) Manual BackBoard Replacement “H” Strap Kit 15440 14910 Supply Hose 10 Ft. 14950 Supply Hose 15 Ft.

  • Page 43: 6-Warranty And Factory Service Information

    All repairs necessitated by malfunction of this equipment during the warranty period when in normal use in accordance with instructions provided will be accomplished at the Michigan Instruments factory, or authorized service facility, without charge other than the cost of transportation to the factory or authorized service facility.

  • Page 44: Factory Service Policy

    MUST be serviced at the factory. B. If you find that factory service is required, call the Michigan Instruments Service Department at (800) 530-9939 between the hours of 9:00am and 5:00pm EST. Please have available the model number, serial number, and a description of the problem.

  • Page 45: Additional Terms

    6.3.2 Additional Terms: All non-warranty devices returned to Michigan Instruments must be evaluated and require an evaluation fee plus return shipping charges. This fee will be charged ONLY if repairs are not authorized and the device must be returned unrepaired.
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  • Page 47: Glossary

    GLOSSARY TERMS USED IN MANUAL ACLS Advanced Cardiac Life Support. AED Automatic external defibrillator AHA American Heart Association. A-P Diameter Anterior-Posterior dimension of the chest. Thickness of chest over the sternum measured front to back. CPR (Cardiopulmonary Resuscitation) Resuscitation, combining both artificial circulation of the blood and artificial breathing.
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