Impact 731 User manual

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Table of Contents

INTRODUCTION ............................................................................................................................................. 3

Conventions ................................................................................................................................................... 3

Terminology and Abbreviations..................................................................................................................... 3

General Warnings .......................................................................................................................................... 4

Cautionary Note ............................................................................................................................................. 4

Helpful Hints .................................................................................................................................................. 4

Limited Copyright Release ............................................................................................................................ 4

Warranty ........................................................................................................................................................ 5

Masimo Pulse Oximeter ................................................................................................................................. 5

WARNINGS AND CAUTIONS REGARDING USE....................................................................................... 6

731Series and Pulse Oximeter ....................................................................................................................... 6

Pulse Oximeter Specific Warnings And Cautions.......................................................................................... 7

MAINTENANCE .............................................................................................................................................. 9

Routine Inspections ........................................................................................................................................ 9

Cleaning ..................................................................................................................................................... 9

Storage Information ..................................................................................................................................10

Post-Contaminated Environment Cleaning ...............................................................................................10

Removable Foam Filter Replacement .......................................................................................................11

Fresh Gas/Emergency Air Intake Disk Filter Replacement ......................................................................11

Battery Capacity, Care and Recharging ....................................................................................................12

Preventive Maintenance (PM) .......................................................................................................................13

Periodic Maintenance Check (PMC) .........................................................................................................13

Troubleshooting and Repairs ............................................................................................................................15

Service Kits ...................................................................................................................................................15

Service Kit Listing ....................................................................................................................................16

Replacement Instructions ..........................................................................................................................17

Membrane Panel Kit 712-0731-01 / 712-EGL2-01 ...............................................................................17

SPM Kit 712-0731-02 / 712-EGL2-02 ..................................................................................................21

Battery Compartment Kit 712-0731-03 / 712-EGL2-03 .......................................................................25

Outer Air Intake Kit 712-0731-04 / 712-EGL2-04 ...............................................................................26

Bezel Assembly Kit 712-0731-05 / 712-EGL2-05 / 712-AEV1-01 ......................................................27

Power Knob Kit 712-0731-06 / 712-EGL2-06 ......................................................................................29

USB Connector Plate Kit 712-0731-07 / 712-EGL2-07 .......................................................................31

Front Case Assembly Kit 712-0731-08 / 712-EGL2-08 / 712-AEV1-02 ..............................................34

Battery Case Bottom Cover Kit 712-0731-09 / 712-EGL2-09 ..............................................................36

EMV Chassis Kit 712-0731-10 / 712-EGL2-10 ....................................................................................37

Connector Panel Kit 712-0731-11 / 712-EGL2-11 ...............................................................................41

Back Case Kit 712-0731-12 / 712-EGL2-12 .........................................................................................45

PIM Board Kit 702-0731-02 .................................................................................................................46

CPU/UIM & SPO2 Stack Kit 712-0731-14 ..........................................................................................49

USB Connector Kit 712-0731-15 ..........................................................................................................52

Gas Output Kit 712-0731-16 .................................................................................................................54

Power Input Kit 712-0731-17 ...............................................................................................................55

Oxygen Inlet Fitting Kit 712-0731-18...................................................................................................59

Selector Knob Kit 712-0731-19 / 392-0066-00.....................................................................................60

Troubleshooting ............................................................................................................................................62

Alarm Category .........................................................................................................................................62

Service Codes ............................................................................................................................................63

HiPot Testing ....................................................................................................................................................68

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INTRODUCTION

A/C- Assist/Control

LED - Light Emitting Diode

ACLS- Advanced Cardiac Life Support

LPM - Liters per Minute

ALS- Advanced Life Support

ml - Milliliters

ATLS- Advanced Trauma Life Support

mm - Millimeter

ACV- Assist-Control Ventilation

NPPV – Noninvasive Positive Pressure

Ventilation

ATPD - Atmospheric Temperature and Pressure, Dry

O2 - Oxygen

BPM - Breaths per Minute

Paw - Airway Pressure

B/V - Bacterial/Viral Filter

PEEP - Positive End Expiratory Pressure

cm H2O - Centimeters of Water

PIP - Peak Inspiratory Pressure

CPR - Cardiopulmonary Resuscitation

psig - Pounds per Square Inch Gage

DISS - Diameter Index Safety System

USP - United States Pharmacopeia

FIO

2 -

Fraction of Inspired Oxygen

VAC - Volts AC

HME - Heat and Moisture Exchanger

VDC - Volts DC

HME/BV - Heat and Moisture Exchanger/Bacterial

Viral filter combined

VT - Tidal Volume Hz – Hertz (as in frequency, cycles per second)

WOB – Work of Breathing

ID - Internal Diameter

L - Liters

Conventions

WARNING!

A WARNING statement identifies conditions or information that could have an adverse effect upon the patient or operator which if not avoided, could result in death or serious injury.

CAUTION!

A CAUTION statement provides important information about a potentially hazardous situation which if not avoided may result in minor or moderate injury to the patient, operator or damage to the equipment or other property.

NOTE:

A NOTE provides additional information intended to avoid inconvenience during operation.

Terminology and Abbreviations

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General Warnings

The design and intended use of 731 series ventilators requires that the operation of the product be restricted to trained medical professionals. US federal law restricts this device for sale by or on the order of a physician.

The information contained herein is restricted for use by personnel certified by Impact Instrumentation, Inc. in the care and servicing of this product. Impact does not authorize or assume any obligations resulting from unauthorized servicing of its products nor will it be held liable for any injuries or damages incurred therefrom.

This device has been classified "life supporting" and "life sustaining" by the United States Food & Drug Administration. If you have not been trained and certified by Impact Instrumentation, Inc in the care and servicing of this product, DO NOT attempt to service this device. Should factory based servicing become necessary, or technical assistance is required, please have the device’s Model and Serial Number available and contact the Impact service team. All service requests, including requests to schedule service training, may be addressed to the Service Manager, Impact Instrumentation, Inc., 19 Fairfield Place, West Caldwell, New Jersey 07006, 973/882-1212 or email: service@impactii.com .

Cautionary Note

Prior to servicing this device, be aware of the presence of potentially dangerous operating voltages.

Disconnect power supply and the internal battery prior to performing any service.

Internal components are susceptible to damage from static discharge. All servicing operations MUST be done in an ESD controlled environment.

Please review all warnings and cautions in this manual, the device’s Operation manual and the RCS Operation manual prior to servicing the 731 series ventilator.

Helpful Hints

Before attempting to service this instrument, please take a few moments to ensure that the problem is not accessory-related. Always check the integrity of all tubing and fittings and verify that tubing is not crimped or cracked.

Always safeguard your personal well being when troubleshooting electronic circuitry. Keep jewelry and liquids from the vicinity of active circuitry.

Limited Copyright Release

Permission is hereby granted to any United States Military or Governmental agency to reproduce all materials furnished herein for use in a United States Military or Governmental service training program. No other individual, company or agency are granted the permission to copy or reproduce any materials furnished herein without the written permission of Impact®.

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Warranty

Impact Instrumentation, Inc. warrants 731 series devices and their replacement service part kits to be free from all defects in material and workmanship for a period of one (1) year from the date of delivery to the final purchaser

During the warranty period, Impact will repair or replace the device or any part which upon examination is shown to be defective. At its sole discretion, Impact may choose to supply a new or equivalent replacement product or refund the amount of the purchase price. To qualify for such repair, replacement, or refund, the defective device must be returned to Impact or Impact’s authorized service provider within thirty (30) days from the date that the defect is discovered. This warranty does not apply if the device has been repaired or modified without the authorization of Impact or if the damage was caused by incorrect storage, failure to perform recommended maintenance, use of the product in applications not described in the intended use statement, negligence or an accident.

Batteries, which by their nature are consumable and subjected to environmental extremes, will be warranted for a period of ninety (90) days. Accessories, also consumable in usage, such as connecting hose and breathing circuits, are not warranted.

DISCLAIMER OF IMPLIED & OTHER WARRANTIES:

THE PRECEDING WARRANTY IS THE EXCLUSIVE WARRANTY AND IMPACT INTRUMENTATION, INC. MAKES NO OTHER WARRANTY OR REPRESENTATION OF ANY KIND WHATSOEVER, EXPRESSED OR IMPLIED, WITH RESPECT TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER. THE REMEDIES STATED IN THIS DOCUMENT WILL BE THE EXCLUSIVE REMEDIES AVAILABLE FOR ANY DEFECTS OR FOR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER AND WIHOUT LIMITATION.

IMPACT INSTRUMENTATION, INC. WILL NOT IN ANY EVENT BE LIABLE FOR CONSEQUENTIAL OR INCEDENTAL DAMAGES OF ANY KIND, WHETHER FROM DEFECTIVE OR NONCONFORMING PRODUCTS, BREACH OR REPUDIATION OF ANY TERM OR CONTTION OF THE DOCUMENT, NEGLIGENCE, OR ANY OTHER REASON

THE WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, WHICH ARE HEREBY DISCLAIMED AND EXCLUDED BY SELLER, INCLUDING WITHOUT LIMITATION ANY WARRANY OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE OR USE.

Masimo Pulse Oximeter

This device uses Masimo SET® technology to provide continuous pulse oximeter and heart rate monitoring and is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975 and other applicable patents listed at www.masimo.com/patents.htm.

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WARNING! Electric shock hazard: Do not remove equipment covers except to replace batteries! An operator may only perform maintenance procedures specifically described in this manual. Refer servicing to Impact or an authorized Impact Service Center in the repair of this equipment.

WARNING! The device is intended for use by qualified personnel only! The operator should read this manual, all precautionary information, and specifications before using the device!

WARNING! Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments or nitrous oxide!

WARNING! During operation the device should not be stacked on top of or under other medical equipment due to the possibility of electromagnetic interference between the device and other equipment. (The device was subjected to EMC testing in accordance with Military Mil-STD-461F and Commercial IEC 606011-2 and FDA Reviewers Guidance specifications.)

WARNING! Grounding:

Connect the device only to a three-wire, grounded, hospital-grade receptacle! The three-conductor

plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code.

Do not under any circumstances remove the grounding conductor from the power plug! Do not use extension cords or adapters of any type! The power cord and plug must be intact and

undamaged.

If there is any doubt about the integrity of the protective earth conductor arrangement, operate the

oximeter on internal battery power until the AC power supply protective conductor is fully functional!

WARNING! To ensure patient electrical isolation, connect only to other equipment with electronically isolated circuits!

WARNING! Do not use antistatic or conductive hoses or tubing with this device! WARNING! Do not connect to an electrical outlet controlled by a wall switch or dimmer!

WARNING! As with all medical equipment, carefully route the ventilator circuit hose and tubing, patient

cabling, and external power cables to reduce the possibility of patient entanglement or strangulation!

WARNING! Do not place the device or external power supply in any position that might cause it to fall on the patient! Do not lift the device by the power supply cord, ventilator circuit or pulse oximeter patient cable!

WARNING! Do not use the device, its pulse oximeter or pulse oximetry sensors during magnetic resonance imaging (MRI) scanning! Induced current could potentially cause burns. The device and/or its pulse oximeter may affect the MRI image and the MRI unit may affect device operation or the accuracy of the oximetry measurements.

WARNING! The device must be connected to a grounded AC power supply when connected to AC power. The device and its integrated pulse oximeter are referred to as an IEC 601/F device in the summary situation table contained in IEC-601-1-1.

WARNING! USB Interconnection: Do not operate the device on a patient when the USB is connected to any other device.

NOTE: The USB interconnection does not support automatic record keeping.

WARNING! The Impact supplied ventilator circuit’s labeling provides the resistance and compliance values

for the circuits under normal operating conditions. If added accessories are used (e.g. humidification, filters etc.), the operator should assure they do not degrade the performance of the device. If non-Impact circuits are used, the operator should assure these circuits do not affect the performance of the device.

CAUTION! Federal law restricts this device to sale by or on the order of a physician.

CAUTION! Service is to be performed by qualified biomedical equipment technicians only.

WARNINGS AND CAUTIONS REGARDING USE

731Series and Pulse Oximeter

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CAUTION! Internal components are susceptible to damage from static discharge. Do not remove device covers.

NOTE: This Operation Manual is not meant to supersede any controlling standard operating procedure regarding the safe use of assisted ventilation.

NOTE: Follow all governing regulations regarding the disposal of any part of this medical device.

NOTE: Follow all governing regulations regarding the handling of materials contaminated by body fluids.

NOTE: Follow all governing regulations regarding shipment of the Li batteries.

WARNING! A pulse oximeter should not be used as an apnea monitor.

WARNING! A pulse oximeter should be considered an early warning device. As a trend towards patient

deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely

understand the patient’s condition.

WARNING! MEASUREMENTS If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper functioning. Inaccurate measurements may be caused by:

Incorrect sensor application or use Significant levels of dysfunctional hemoglobin (e.g., carboxyhemoglobin or methemoglobin) Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source),

bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material)

Excessive patient movement Venous pulsations Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular

line

The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a short

time.

WARNING! Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.

WARNING! ALARMS Check alarm limits each time the pulse oximeter is used to ensure that they are appropriate for the patient being monitored.

WARNING! Loss of pulse signal can occur in any of the following situations:

The sensor is too tight There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight A blood pressure cuff is inflated on the same extremity as the one with a SpO

sensor attached

The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia There is arterial occlusion proximal to the sensor

The patient is in cardiac arrest or is in shock

Pulse Oximeter Specific Warnings And Cautions

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WARNING! Sensors:

Before use, carefully read the LNCS

sensor directions for use.

Use only Masimo oximetry sensors for SpO

measurements. Other oxygen transducers (sensors)

may cause improper performance.

Tissue damage can be caused by incorrect application or use of an LNCS

sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.

Do not damage LNCS

sensors. Do not use an LNCS® sensor with exposed optical components. Do not immerse the sensor in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo LNCS® sensors.

Do not use damaged patient cables. Do not immerse the patient cables in water, solvents or

cleaning solutions (the patient cables are not waterproof). Do not sterilize by irradiation, steam or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo patient cables.

CAUTION! Possession or purchase of this device does not convey any expressed or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device fall within the scope of one or more of the patents relating to this device. Impact cannot assure the proper functioning of this device if it is used with unauthorized sensors or cables.

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MAINTENANCE

Operational inspection – after every 1,000 hours of use or more frequently if the ventilator has been used in austere environments, confirm that that device functions properly by power cycling the ventilator while it is connected to a ventilator circuit and test lung. Operate the ventilator at its default settings and exercise the membrane buttons and the rotary optical encoder to ensure they operate as intended.

Accessory inspection – replace power supply if there is damaged or cracked casing, plugs, or cut/frayed or exposed wiring.

Filter inspection – check the foam and disk filter for dust/dirt build up and/or physical damage. Replace if dirt is visible or filter is damaged.

Battery inspection – check the battery icon to ensure battery is charging and that the ventilator operates correctly.

Breathing circuit inspection – check on a daily basis the breathing circuit for damage or wear including but not limited to cracking, discoloration or disfigurement. If there is any sign of physical degradation or the unit is indicating breathing circuit problems, replace with a new breathing circuit.

High Pressure Hoses inspection: Examine hoses for cracking, discoloration and disfigurement. Wipe the exterior wall with a damp, soapy cloth. Dry with a lint-free cloth. Examine end connection fittings for damaged threads and sharp edges. Replace if defective, DO NOT attempt to repair.

This device should be incorporated into a regular maintenance program to ensure safe and effective operation. Electro-mechanical and pneumatic components are subject to wear and fatigue over time and components will deteriorate more quickly when used continuously. To maintain safe operation, it is the user's responsibility to ensure that periodic inspections and maintenance is performed and that recommended maintenance is performed by Impact or a certified Impact trained technician.

Routine Inspections

Routine inspections should be performed on this ventilator at regular intervals and prior to its being placed into service. Routine inspections consist of the following:

Cleaning

1. The ventilator’s outer case should be cleaned with a damp soapy cloth and thoroughly dried with a

lint-free cloth. Make sure that all exposed surfaces are cleaned and dried.

2. For general decontamination/cleaning situations, a 10% bleach solution applied with a damp cloth

is an effective decontaminant that can be used. Since the potential amount of contaminants that our ventilators might be exposed to is so large, it is difficult to provide an appropriate cleaning method for each type of exposure. An effective cleaning agent for one type of exposure may not be effective with another and cleaning and sterilizing practices may vary between institutions. Impact Instrumentation, Inc. suggests that each facility have in place a procedure for the cleaning and disinfection of its medical equipment and that these procedures be consulted for further guidance.

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3. Care must be taken to prevent liquids from entering the ventilator. Never submerge the ventilator

WARNING! Never use oil or grease of any kind with O2 or compressed gas equipment.

CAUTION! DO NOT store batteries in a discharged condition.

and avoid using excessive amounts of water that might enter the unit.

4. Never use abrasives or chlorinated hydrocarbon based cleansers when cleaning the ventilator, they

will damage the plastic and interface lens.

Storage Information

For optimal prolonged storage periods, the device should be stored indoors. The environment should be clean and out of direct sunlight. Storage in non-controlled environments is permissible if batteries are removed.

For long-term storage, the optimum storage temperature range is -15 C to 21 C (5 F to 71 F). Battery life is diminished at temperatures above 35 C (95 F). It is recommended that batteries be discharged to 50% capacity if long term storage above 35 C (95 F) is expected. DO NOT store batteries in a discharged condition. Short-term, less than 10 days, storage temperatures should range between -15 C to 49 C (5 F and 120 F) with no degradation to the device.

When batteries are in extended storage, it is recommended that they receive a refresh charge at recommended intervals when not continuously connected to an external power source:

STORAGE AMBIENT RECHARGE INTERVAL

Below 68 F (20 C) 12-months 68 F to 86 F (20 C to 30 C) 6-months 86 F to 104 F (30 C to 40 C) 3-months

Following periods of extended storage in non-controlled environments, allow the device sufficient time to stabilize to a temperature within its specified operating range (see section entitled BATTERY CARE AND RECHARGING).

If the device is subject to 6-months of continuous storage/non-use, or longer, this device should be powered

on to initiate the device’s self test routine. The user should confirm that the batteries are sufficiently

charged before patient-use is attempted.

Post-Contaminated Environment Cleaning

If the ventilator is operated in an environment where it may have been exposed to contamination from a hazardous materials accident, mass epidemic or weapon of mass destruction, Impact recommends that the guidelines below be followed.

1. The ventilator’s outer case should be cleaned with a damp soapy cloth and thoroughly dried

with a lint-free cloth. Make sure that all exposed surfaces are cleaned and dried.

2. For general decontamination/cleaning situations, a 10% bleach solution applied with a damp

cloth is an effective decontaminant that can be used. Since the potential amount of contaminants that our ventilators might be exposed to is so large, it is difficult to provide an appropriate cleaning method for each type of exposure. An effective cleaning agent for one type of exposure may not be effective with another and cleaning and sterilizing practices may vary between institutions. Impact Instrumentation, Inc. suggests that each facility have in place

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a procedure for the cleaning and disinfection of its medical equipment and that these

CAUTION! Do not operate the compressor without a filter in place.

CAUTION! There are no user serviceable parts except the filter components described above.

CAUTION! When used in dusty/dirty environments the foam and disk filters should be checked, and

replaced as needed. This will prevent particle build up on the transducer screen and the need to take the unit out of service for maintenance by a biomedical technician.

procedures be consulted for further guidance.

3. Care must be taken to prevent liquids from entering the ventilator. Never submerge the

ventilator and avoid using excessive amounts of water that might enter the unit.

4. Never use abrasives or chlorinated hydrocarbon based cleansers when cleaning the ventilator,

they will damage the plastic and interface lens.

5. Always follow the decontamination procedures specified by the local Incident Command Safety

Officer.

6. Equipment should be cleaned and decontaminated as soon as possible after use. Personnel

should always wear the appropriate Personal Protective Equipment while decontaminating equipment.

7. The ventilator’s outer case should be cleaned with a damp soapy cloth and thoroughly dried

with a lint-free cloth. Make sure that all exposed surfaces are cleaned and dried.

8. For general decontamination/cleaning situations, a 10% bleach solution applied with a damp

9. Care must be taken to prevent liquids from entering the ventilator. Never submerge the

ventilator and avoid using excessive amounts of water that might enter the unit.

10. Never use abrasives or chlorinated hydrocarbon based cleansers when cleaning the ventilator,

they will damage the plastic and interface lens.

Removable Foam Filter Replacement

Removable Foam Filter: The Removable Foam Filter is located on the right side of the ventilator. It should be inspected and replaced if needed every 1,000 hours of operation or more frequently if used in dusty environments. Remove the filter using a pair of tweezers or similar tool. Examine the filter for dirt, lint, or general wear. Replace if necessary (Part # 465-0028-00). DO NOT attempt to clean this filter.

Fresh Gas/Emergency Air Intake Disk Filter Replacement

Fresh Gas/Emergency Air Intake Disk Filter: The Fresh Gas/Emergency Air Intake Disk Filter (Part #4650027-00) is located behind the Removable Foam Filter. This filter provides a second level of filtration to the ambient air that is delivered to the patient. This filter must be checked periodically and replaced when necessary. The device triggers an alarm when the combination of Removable Foam Filter and Fresh Gas/Emergency Air Intake Disk Filter become dirty. This alarm signifies that the device is still able to deliver the correct tidal volume but one or more of its filters need replacement. The Fresh Gas/Emergency Air Intake Disk Filter can be visually inspected after the Removable Foam Filter is removed. If the filter appears discolored it must be replaced. See Appendix 5 in the Operation Manual: Internal Filter Change/Insertion.

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CAUTION! If filters have been exposed to biological matter dispose of them following Universal Precaution procedures for your facility.

NOTE: Do not attempt to clean this filter and do not operate internal compressor without filter in place.

CAUTION! Only use the Power Supply provided with the unit. Use of any other power supply could cause

damage or create a fire and/or destroy the battery and unit.

CAUTION! If you witness a battery or the battery compartment starting to balloon, swell up, smoke or feel excessively hot, turn off the unit, disconnect external power and observe it in a safe place for approximately 15 minutes and send the unit for service. Never puncture or disassemble the battery packs or cells.

CAUTION! Never attempt to completely discharge the battery by shorting or some other method and never ship the battery in a completely discharged state.

CAUTION! During continuous, uninterrupted use (>100 hours) it is recommended that the ventilator be disconnected from AC power for 30 seconds to allow the battery to run diagnostics while the battery is discharging.

NOTE: The ventilator continuously monitors the available power sources; occasionally a false low priority power alarm can be triggered for ~1 second. These false alarms immediately clear themselves.

Battery Capacity, Care and Recharging

While the unit is operating on battery power, users can best determine the relative amount of charge in the internal battery by looking at the BATTERY Icon/Indicator. The BATTERY icon appears in outline form and is filled with horizontal rows of lines indicating its current capacity. Each line represents approximately 5% of battery capacity.

The device uses a rechargeable lithium-ion battery which offers a wide temperature operating range, does not exhibit "memory" characteristics (reduced capacity) or vent hydrogen gas. The life of this battery depends, to a great extent, upon the care it receives. Avoid exposing it to direct sunlight or heat sources and never store the battery at temperatures above 76 °C (170 °F) for more than 2 hours. Following these simple guidelines will prevent premature charge depletion and reduction of battery life.

If the unit was supplied without the battery installed or battery replacement is required see Appendix 4: Internal Battery Change/Insertion.

1. Battery charging is controlled by ventilator in the temperature range of 0 C to 45 C (32F to 113 F)

to provide the best life time for the battery

2. The battery has a discharge (operational) temperature range of -25° to 49° C (-13 F to 120 F) (as

validated by Impact Instrumentation).

3. DO NOT store the ventilator with the batteries discharged. Always store with the battery fully

charged.

4. For long-term storage, the optimum storage temperature range is -15 C to 21 C (5 F to 71 F).

Lithium-ion batteries exhibit excellent charge retention characteristics. Prolonged periods of disuse will not substantially reduce operating capability. If long-term storage/non-use is common, recharge the unit every six months; this will insure that battery charge is maintained at 80% capacity or better. The 731 series devices’ battery rapidly recharges to 90% of its capacity in approximately 2 hours. It will take approximately another 2 hours of trickle-charging to top off the battery to 100% of its capacity. Continuous charging is permissible with the supplied 12 VDC Power Cable or AC/DC Power Supply.

Operating power will always default to the external power source to preserve the internal battery charge. This assures that power is available for transport use or emergency back-up. If the EXTERNAL POWER LOW/ FAIL alarm occurs, the device will automatically revert to its internal batteries for operating power.

The BATTERY Icon/Indicator – indicates (1) the presence of a functional battery, (2) when the battery is charging and (3) what its current capacity is. The BATTERY icon appears in outline form and is filled with

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horizontal rows of lines indicating its current capacity. When the battery is charging, these horizontal rows

Maintenance Activity

Year after initial purchase of ventilator

1 2 3 4 5 6 7

Replace inlet oxygen and compressor foam

and disk filters

* * * * * * *

Perform a Periodic Maintenance Check

(PMC)

* * * * * * *

Replace the main battery

Replace the real time clock battery (RTC)

Inspect and replace if needed any internal

tubing, gaskets, or O-Rings that show signs of

wear

Inspect internal pneumatic & electro-

mechanical components

of lines cyclically scroll vertically, one row at a time, from the bottom row to the top. When the battery is fully charged, the icon is completely filled with lines and scrolling stops. Each line represents approximately 5% of battery capacity. During internal battery operation a horizontal line “disappears” as battery capacity is reduced by a 5% increment. The BATTERY icon will flash off/on when a BATTERY POWER LOW alarm occurs. The icon will flash off/on and present with a diagonal line when no battery is connected.

Preventive Maintenance (PM)

Scheduled replacement of filters, batteries, seals and mechanical/pneumatic moving parts will ensure the device is always operating at peak performance. The table below describes the scheduled interval for routine parts replacement, calibration and functional testing. Ventilators used in extreme environments may warrant earlier or more frequent maintenance scheduling.

Table 1 Maintenance Schedule.

Periodic Maintenance Check (PMC)

At start up, the device performs a self check that includes a check for pre-existing alarm conditions. Following start up, the presence of alarm conditions is checked continuously. When in operation the ventilator circuit connects to a pressure transducer in the ventilator. Periodically, the transducer recalibrates itself using the ambient air pressure as a reference. This process maintains a consistent transducer baseline over a wide temperature and altitude range to assure display, monitoring and triggering accuracy.

The ventilator also automatically performs an AUTO CAL procedure that affects 3 transducer systems: Compressor Flow, Oxygen Flow and Airway Pressure. The purpose of AUTO CAL is to compensate for small temperature related drifts in the transducer offset (zeroing). The AUTO CAL is performed at start up during the self check and then every 5 minutes thereafter. However, if a temperature change emceeing +/-1.5oC is sensed, the AUTO CAL time interval is reduced automatically to assure a stable pressure measurement baseline. This continuous correction for variations in ambient temperature and pressure enable the ventilator to deliver targeted volumes and pressure over the entire operating altitude and temperature ranges described in the operations manual.

The automated self check at start up and the AUTO CAL tests confirm that the device is operating within its specifications when in use. If the start up or AUTO CAL tests fail, the unit will not operate. Because the automated tests do not confirm that flow and pressure outputs from the device are verified against a controlled external pressure, flow and temperature measurement device, the PMC procedure should be done every 12 months or after 1,500 hours of use, or to reset the ‘performance maintenance check’ low

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priority alarm, to document that the ventilator has been maintained and is operating properly. The PMC

Picture

Description

Kit #

Annual Preventive Maintenance Kit

712-0731-20

4-Year Preventive Maintenance Kit

712-0731-21

should also be performed whenever the operator suspects that the device is not functioning properly or following mass deployment and before the device is returned to storage. If the device fails the PMC it should be maintained by a certified Impact service technician in the field or at Impact authorized service locations. A secure record of PMC results should be maintained for devices not returned to Impact for maintenance.

Impact’s 731 series service tool the RCS is needed to perform the PMC and reset the ‘performance maintenance check’ low priority alarm. This tool includes can be purchased from Impact for use by Impact

trained and certified biomedical technicians. Alternatively, 731 series can be sent to an Impact authorized service center for PMC or other service requirements.

In addition to automating and documenting the PMC process, the RCS is also capable of calibrating the device and installing and verifying software upgrades and updates to the 731 series of devices.

If you would like to return the ventilator to Impact for service please contact Impact prior to returning this instrument. (Telephone 973.882.1212, email service@impactii.com). A Returned-Goods-Authorization number (RGA #) will be issued. The RGA # must appear on both the packing slip and address label. This will facilitate better tracking of the returned item and result in improved scheduling and handling.

Annual and 4-Year PM Kits are available to trained personnel and service centers.

906-0731-04 Rev. B Sept. 2012 Page 14 of 68

Troubleshooting and Repairs

The device uses a comprehensive suite of alarms to alert the operator and guide their actions to resolve the alarm condition and assure patient safety. At the onset of an alarm, the screen displays the alarm name and then a series of context-sensitive help messages (see Figure 2 example). These messages serve to guide the operator by presenting suggestions as to the cause and resolution of a particular alarm. When multiple alarms occur they are prioritized and displayed based on the risk to the patient. Should the operator not be able to correct the problem, the ventilator should be taken out of use and sent to an authorized Impact repair facility.

Trained bio-med technicians are encouraged to use a systematic approach to solving issues with the ventilator. Use the Alarm Category and Service Code matrices listed in Appendix to resolve the problem or to identify the suggested replacement service kit. Check on-hand availability or order the kit(s) from Impact, then follow the detailed instructions listed to replace the kit. Trained repair facilities can contact Impact’s technical service department via email: service @impactii.com or by telephone toll free: 800-969-0750 or 973-882-1212 for troubleshooting and repair recommendations.

ALARM & PLOT LIST: FIGURE 2

Service Kits

Service kits, which are preassembled and factory tested subassemblies, are available should physical damage or problems of an unforeseen nature arise. Service kits are available only to qualified trained biomedical personnel or authorized Impact service centers. Each kit replacement must be followed by a HiPot test (See section titled HiPot Testing ), then either by a functional test or a calibration and functional test using the Remote Calibration System (RCS).The following table lists the kits for each 731 series model.

906-0731-04 Rev. B Sept. 2012 Page 15 of 68

Service Kit Listing

Description

EMVP

Eagle II

Picture

Kit #

Picture

Kit#

Membrane Panel Kit

712-0731-01

712-EGL2-01

SPM/Vent Assembly Kit

712-0731-02

712-EGL2-02

Battery Compartment Kit

712-0731-03

712-EGL2-03

712-EGL2-13 (MR)

Outer Air Intake Kit

712-0731-04

712-EGL2-04

Bezel Assembly Kit

712-0731-05 (EMVP)

712-AEV1-01 (AEV)

712-EGL2-05

Power Knob Kit

712-0731-06

712-EGL2-06

USB Connector Plate Kit

712-0731-07

712-EGL2-07

Front Case Assembly Kit

712-0731-08 (EMVP)

712-AEV1-02 (AEV)

712-EGL2-08

Battery Case Bottom Cover Kit

712-0731-09

712-EGL2-08

EMV Chassis Kit

712-0731-10

712-EGL2-10

Connector Panel Kit

712-0731-11

712-EGL2-11

Back Case Kit

712-0731-12

712-EGL2-12

PIM Board Kit

702-0731-02

CPU/UIM & SPO2 Stack Kit

712-0731-14

USB Connector Kit

712-0731-15

Gas Output Kit

712-0731-16

Power Input Kit

712-0731-17

Oxygen Inlet Fitting Kit

712-0731-18

Selector Knob Kit

712-0731-19

392-0066-00

906-0731-04 Rev. B Sept. 2012 Page 16 of 68

Replacement Instructions

STEP NO.

DIRECTIONS

Loosen but do not remove the

(4) 8-32 X 3 screws on the outer air

intake.

Loosen and remove the (2) 10-32

Keps nuts and the (4) 6-32 X 2

screws. Remove the back case by

lifting from the ventilator.

Remove the (2) 4-40 X ¼ screws on the Dovetail Mounting Bracket and disconnect the ribbon cable on the

PIM PCB by simultaneously applying

pressure on the two locking “ears”.

ITEM

QTY

DESCRIPTION

Membrane Panel Assembly

Screw, Phillips, Pan Head, Zinc Plated, 4-40 X 1/4

Power Select Knob with Set screw

Selector Knob

CAUTION! Internal components are susceptible to damage from static discharge. All servicing

operations MUST be done in an ESD controlled environment. CAUTION! Disconnect external power and battery pack prior to performing any service.

Membrane Panel Kit 712-0731-01 / 712-EGL2-01

Contents:

Instructions:

906-0731-04 Rev. B Sept. 2012 Page 17 of 68

Flip the ventilator over and remove

the front case assembly by lifting it

straight up away from the ventilator

module.

Remove the bezel by loosening and

removing the (7) 4-40 X ¼ screws

that hold the bezel to the front case.

Using a sharp knife, carefully cut the

RTV sealant around the USB Printed

Circuit Board and around the SPO2

Connector. Be careful not to cut

either cable.

Loosen and remove the two 4-40 X

3/16 screws holding the Mini USB

Cable Assembly to the front case.

Loosen and remove the two M2.5 X

5mm screws holding the SPO2 cable

to the front case.

Loosen and remove the two (2)

6-32 X 5/16 screws that hold the

CPU/UIM & SPO2 Stack to the front

case.

Lift the CPU/UIM & SPO2 Stack up

from the front case. Handle the

SPO2 cable with extreme care. Do

not pull on the cable.

Loosen and remove the two 4-40 X

5/16 screws holding the USB

Connector Plate to the front case.

906-0731-04 Rev. B Sept. 2012 Page 18 of 68

Tighten the two 4-40 X 5/16 screws

holding the USB Connector Plate to

the replacement front case. Tighten

the two (2) 6-32 X 5/16 screws that hold the CPU/UIM & SPO2 Stack to

the front case. Make sure that all the

pins on the header mate correctly.

Make sure the SPO2 Flex Cable lays

flat against the front case and is

assembled correctly into the UIM

Bracket and SPO2 Isolation Shield.

Insert and tighten the two M2.5 X

5mm screws holding the SPO2 cable

to the front case.

Remove any excess RTV sealant from

the SPO2 flex cable and USB PCB.

Tighten the two 4-40 X 3/16 screws

holding the USB PCB to the front

case. Apply RTV sealant to USB PCB

and SPO2 flex cable. Allow to

dry/cure.

Dress the USB Connector cable along

the case and over the SPO2 flex

cable.

Place the included power knob on the new membrane panel switch -

align with flat on switch – insert the

included 6-32 X ¼ set screw and

tighten. Push the included selector

knob on the membrane panel switch

- align with flat on switch .

Place the front case assembly on to

the bezel and tighten the included

(7) 4-40 X ¼ screws.

906-0731-04 Rev. B Sept. 2012 Page 19 of 68

Place the front case assembly over

the vent module and tighten the (2)

4-40 X ¼ screws unto the dovetail

mounting bracket. Reconnect the

ribbon cable unto the PIM PCB.

Make sure the two locking “ears”

lock into position.

Attach the back case to the vent

module and align cover with handle,

air intake housing and dovetail

mounting studs. Insert and tighten

the included (2) 10-32 Keps nuts and

the (4) 6-32 X 2” screws.

Tighten the (4) 8-32 X 3 screws on

the outer air intake.

Perform HiPot Testing then perform

Calibration and Functional Test using

the RCS.

906-0731-04 Rev. B Sept. 2012 Page 20 of 68

SPM Kit 712-0731-02 / 712-EGL2-02

STEP NO.

DIRECTIONS

Loosen but do not remove the

(4) 8-32 X 3 screws on the outer air

intake.

Loosen and remove the (2) 10-32

Keps nuts and the (4) 6-32 X 2

screws. Remove the back case by

lifting from the ventilator.

Remove the (2) 4-40 X ¼ screws on the Dovetail Mounting Bracket and disconnect the ribbon cable on the

PIM PCB by simultaneously applying

pressure on the two locking “ears”.

Flip the ventilator over and remove

the front case assembly by lifting it

straight up away from the ventilator

module.

Remove the battery compartment cover by unscrewing the (4) 6-32 X

5/16 screws.

Remove the battery by unscrewing

the (4) 6-32 X 2 ¼ screws and

detaching the plug from its locking

latch.

ITEM

QTY

DESCRIPTION

SPM/Vent Assembly

Contents:

Instructions:

906-0731-04 Rev. B Sept. 2012 Page 21 of 68

+ 47 hidden pages

Impact 731 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual