Impact Uni-Vent 731 Series User manual

906-0731-04 Rev. B Sept. 2012 Page 1 of 68

906-0731-04 Rev. B Sept. 2012 Page 2 of 68

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

906-0731-04 Rev. B Sept. 2012 Page 3 of 68

INTRODUCTION

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

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

FIO2 - 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

906-0731-04 Rev. B Sept. 2012 Page 4 of 68

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: ser[email protected] .

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®.

906-0731-04 Rev. B Sept. 2012 Page 5 of 68

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.

906-0731-04 Rev. B Sept. 2012 Page 6 of 68

WARNINGS AND CAUTIONS REGARDING USE

731Series and Pulse Oximeter

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 60601-

1-2 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.

906-0731-04 Rev. B Sept. 2012 Page 7 of 68

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.

Pulse Oximeter Specific Warnings And Cautions

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 SpO2sensor 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

906-0731-04 Rev. B Sept. 2012 Page 8 of 68

WARNING! Sensors:

Before use, carefully read the LNCS®sensor directions for use.

Use only Masimo oximetry sensors for SpO2measurements. 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.

906-0731-04 Rev. B Sept. 2012 Page 9 of 68

MAINTENANCE

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:

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.

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.

906-0731-04 Rev. B Sept. 2012 Page 10 of 68

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.

WARNING! Never use oil or grease of any kind with O2or compressed gas equipment.

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.

CAUTION! DO NOT store batteries in a discharged condition.

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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