impact Uni-Vent 731 Series 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
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

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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: 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®.

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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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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.

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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.
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

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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.

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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.

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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