Invivo Precess 3160 series User manual

Invivo Corporation
3160 MRI PHYSIOLOGICAL MONITORING SYSTEM
OPERATIONS MANUAL

i
TABLE OF CONTENTS
Paragraph Number Page Number
List of Figures ........................................................................................................................................... iv
List of Tables.............................................................................................................................................. v
Equipment Classification ........................................................................................................................ v
Precautions ................................................................................................................................................ vi
User Responsibility ................................................................................................................................xiv
3160 MRI Physiological Monitor Accessories.................................................................................. xv
1.0 INTRODUCTION ......................................................................................................... 1-1
1.1 Product Description ......................................................................................................... 1-1
1.1.1 System Mounting................................................................................................. 1-1
1.1.2 System Parameters............................................................................................... 1-1
1.1.3 User Interface....................................................................................................... 1-2
1.1.4 Versatility............................................................................................................. 1-2
1.2 Wireless Processor Unit (WPU) ...................................................................................... 1-2
1.2.1 Operating Environment........................................................................................ 1-2
1.2.2 Power Supply....................................................................................................... 1-2
1.2.3 Battery Operation................................................................................................. 1-2
1.3 Patient Connections ......................................................................................................... 1-2
1.3.1 NIBP and Agent Monitoring................................................................................ 1-2
1.3.2 ECG Monitoring .................................................................................................. 1-3
1.3.3 SpO2 Monitoring ................................................................................................. 1-3
1.4 Display Control Unit (DCU)............................................................................................ 1-3
1.4.1 DCU Controls ...................................................................................................... 1-3
1.4.2 DCU Display........................................................................................................ 1-8
1.5 Cleaning ......................................................................................................................... 1-12
1.5.1 Cleaning Accessories......................................................................................... 1-12
2.0 INSTALLATION........................................................................................................... 2-1
2.1 Introduction...................................................................................................................... 2-1
2.2 Monitor Installation ......................................................................................................... 2-1
2.2.1 Monitor Mounting................................................................................................ 2-1
2.2.2 Preparing the 3160 MRI Physiological Monitoring System for Use................... 2-1
2.2.3 Monitor Start Up.................................................................................................. 2-1
3.0 PREPARATION FOR USE.......................................................................................... 3-1
3.1 Introduction...................................................................................................................... 3-1
3.2 SETUPS Menu................................................................................................................. 3-1
3.3 Store/Recall Setups ........................................................................................................ 3-20
3.4 Monitor Initialization..................................................................................................... 3-21
3.4.1 Default Initialization .......................................................................................... 3-21
3.4.2 Pre-Configured Initialization ............................................................................. 3-21
4.0 PATIENT PARAMETERS........................................................................................... 4-1
4.1 ECG Monitoring .............................................................................................................. 4-1
4.1.1 Patient and Lead Preparation ............................................................................... 4-1
4.1.2 Associated Waveforms and Displays .................................................................. 4-2
4.1.3 The ECG Menu.................................................................................................... 4-2
4.1.4 Alarm Limits........................................................................................................ 4-5
4.1.5 Trended Data........................................................................................................ 4-5
4.1.6 ECG Messages..................................................................................................... 4-5

ii
TABLE OF CONTENTS
Paragraph Number Page Number
4.2 Non-Invasive Blood Pressure (NIBP) Monitoring .......................................................... 4-5
4.2.1 Theory of Oscillometric Measurement ................................................................ 4-6
4.2.2 Patient and Cuff Preparation................................................................................ 4-7
4.2.3 Associated Displays............................................................................................. 4-7
4.2.4 The NIBP Menu................................................................................................... 4-9
4.2.5 NIBP Menu Options ............................................................................................ 4-9
4.2.6 Using the Automatic Interval Mode .................................................................. 4-11
4.2.7 Manually Starting/Stopping a Reading Cycle ................................................... 4-11
4.2.8 Stat Mode Operation.......................................................................................... 4-11
4.2.9 Alarm Limits...................................................................................................... 4-11
4.2.10 Adult vs. Neonatal Mode Operation .................................................................. 4-11
4.2.11 Trended Data...................................................................................................... 4-11
4.2.12 NIBP Messages.................................................................................................. 4-12
4.3 SpO2 Monitoring ........................................................................................................... 4-12
4.3.1 Sensor Positioning ............................................................................................. 4-12
4.3.2 Associated Waveforms and Displays ................................................................ 4-13
4.3.3 SpO2 Menu ........................................................................................................ 4-13
4.3.4 Alarm Limits...................................................................................................... 4-14
4.3.5 Trended Data...................................................................................................... 4-14
4.3.6 SpO2 Messages.................................................................................................. 4-14
4.4 End-tidal CO2 (EtCO2) Monitoring .............................................................................. 4-15
4.4.1 Patient and Sampling Line Preparation ............................................................. 4-15
4.4.2 Water Trap Replacement ................................................................................... 4-17
4.4.3 Associated Waveforms and Displays ................................................................ 4-17
4.4.4 EtCO2 Menu ...................................................................................................... 4-18
4.4.5 Calibration of CO2/N2O Measurement System ................................................ 4-18
4.4.6 Alarm Limits...................................................................................................... 4-19
4.4.7 Trended Data...................................................................................................... 4-19
4.4.8 EtCO2 Messages................................................................................................ 4-19
4.5 Anesthetic Agent/Oxygen Monitoring........................................................................... 4-20
4.5.1 Patient and Tubing Preparation.......................................................................... 4-20
4.5.2 Associated Displays........................................................................................... 4-21
4.5.3 Agent Menu ....................................................................................................... 4-23
4.5.4 Gas Calibration .................................................................................................. 4-23
4.5.5 Alarm Limits...................................................................................................... 4-24
4.5.6 Trended Data...................................................................................................... 4-24
4.5.7 Agent/O2 Messages ........................................................................................... 4-24
4.5.8 Oxygen Monitoring............................................................................................ 4-25
5.0 RECORDING AND TRENDING ................................................................................ 5-1
5.1 Introduction...................................................................................................................... 5-1
5.1.1 Record Key .......................................................................................................... 5-1
5.2 The RECORDER Menu................................................................................................... 5-1

iii
TABLE OF CONTENTS
Paragraph Number Page Number
5.3 Recording Charts ............................................................................................................. 5-3
5.3.1 Strip Chart Record ............................................................................................... 5-4
5.3.2 Tabular Chart Record........................................................................................... 5-4
5.3.3 Trend Chart .......................................................................................................... 5-5
5.3.4 System Data Report ............................................................................................. 5-5
5.4 Loading Recorder Paper .................................................................................................. 5-5
5.5 Trending Feature.............................................................................................................. 5-5
5.5.1 HISTORY Menu Options .................................................................................... 5-6
6.0 ALARMS ........................................................................................................................ 6-1
6.1 Introduction...................................................................................................................... 6-1
6.2 Alarm Limits.................................................................................................................... 6-1
6.2.1 Default (Pre-Set) Alarm Limits ........................................................................... 6-1
6.2.2 Range of High and Low Alarm Limits ................................................................ 6-1
6.3 Alarm Setup ..................................................................................................................... 6-1
6.3.1 Parameter Alarms Status Screen.......................................................................... 6-4
6.4 Turning Alarms Off on Individual Parameters ................................................................ 6-4
6.5 Alarm Violations.............................................................................................................. 6-4
6.6 Adjusting the Alarm Tone Volume ................................................................................. 6-5
6.6.1 Disabling the Alarm Tone.................................................................................... 6-5
6.7 Standby Mode .................................................................................................................. 6-6
7.0 BATTERY OPERATION............................................................................................. 7-1
7.1 Introduction...................................................................................................................... 7-1
7.2 Battery Location and Access ........................................................................................... 7-1
7.3 Loading and Unloading Battery(s) .................................................................................. 7-1
7.4 Battery Charging.............................................................................................................. 7-1
7.5 Battery Operation Time ................................................................................................... 7-1
7.5.1 Battery Low Indication ........................................................................................ 7-1
7.6 Battery Replacement........................................................................................................ 7-1
Specifications............................................................................................................................. A-1
Repair..........................................................................................................................................B-1
Warranty ....................................................................................................................................C-1
Declaration of Conformity ....................................................................................................... D-1
kPa to mmHg Conversion Chart ..............................................................................................E-1
List of Symbols ........................................................................................................................... F-1

iv
LIST OF FIGURES
Figure Number Page Number
1-1 Patient Connection Unit (PCU) ....................................................................................... 1-2
1-2 The Front Panel................................................................................................................ 1-3
1-3 The Top Keypad Set ........................................................................................................ 1-4
1-4 The Middle Keypad Set ................................................................................................... 1-5
1-5 The Bottom Keypad Set................................................................................................... 1-6
1-6 The Normal Screen .......................................................................................................... 1-8
1-7 The Informational Display............................................................................................... 1-8
1-8 The Vital Signs Trace Display......................................................................................... 1-9
1-9 The Vital Signs Numeric Display.................................................................................. 1-10
3-1 The DCU SETUPS Menu ................................................................................................ 3-1
3-2 The RECALL SETUPS Menu......................................................................................... 3-2
3-3 The STORE SETUPS Menu............................................................................................ 3-3
3-4 The PARAMETER SELECTION Menu......................................................................... 3-4
3-5 The SOUND ADJUST Menu .......................................................................................... 3-5
3-6 The SET TIME Menu ...................................................................................................... 3-7
3-7 NETWORK Menu ........................................................................................................... 3-8
3-8 The DCU SERVICE (BIO-MED) Menu ......................................................................... 3-8
3-9 The SYSTEM CONFIG Menu ........................................................................................ 3-9
3-10 WPU SETUPS Menu..................................................................................................... 3-11
3-11 The PARAMETER SELECTION Menu....................................................................... 3-11
3-12 The SOUND ADJUST Menu ........................................................................................ 3-13
3-13 The SET TIME Menu .................................................................................................... 3-14
3-14 The WPU SERVICE (BIO-MED) Menu....................................................................... 3-15
3-15 NIBP TESTS Menu ....................................................................................................... 3-16
3-16 GAS CAL Menu ............................................................................................................ 3-17
3-17 Monitor Calibration YES/NO Menu.............................................................................. 3-18
3-18 Monitor Calibration Information Screen ....................................................................... 3-18
3-19 System Configuration Menu.......................................................................................... 3-19
4-1 ECG Trace and Numerical Displays................................................................................ 4-1
4-2 The ECG Menu................................................................................................................ 4-2
4-3 The ECG SCALE Sub-Menu........................................................................................... 4-3
4-4 The ECG HR SOURCE Sub-Menu ................................................................................. 4-4
4-5 Oscillometric Measurement Method ............................................................................... 4-6
4-6 The NIBP Display............................................................................................................ 4-7
4-7 The NIBP Menu............................................................................................................... 4-8
4-8 The NIBP INTERVAL Menu.......................................................................................... 4-9
4-9 The HISTORY Menu..................................................................................................... 4-10
4-10 SpO2 Display................................................................................................................. 4-13
4-11 The SpO2 Menu............................................................................................................. 4-13
4-12 The SpO2 SIZE Menu ................................................................................................... 4-14
4-13 The Patient Sampling Circuit......................................................................................... 4-16
4-14 Water Trap Installation Diagram ................................................................................... 4-16
4-15 The EtCO2 Display........................................................................................................ 4-17
4-16 The EtCO2 Menu........................................................................................................... 4-18
4-17 Anesthetic Agents Display............................................................................................. 4-20
5-1 The RECORDER Menu................................................................................................... 5-2

v
LIST OF FIGURES
Figure Number Page Number
5-2 Sample Strip Chart........................................................................................................... 5-4
5-3 Sample Tabular Chart ...................................................................................................... 5-4
5-4 System Data Report ......................................................................................................... 5-5
5-5 Loading the Recorder Paper ............................................................................................ 5-5
5-6 The HISTORY Menu....................................................................................................... 5-6
5-7 The MULTI TRENDS Menu........................................................................................... 5-7
5-8 The Trend SELECT Menu............................................................................................... 5-7
5-9 Sample Multi Trends Printout.......................................................................................... 5-8
6-1 The ALARMS Menu ....................................................................................................... 6-1
6-2 GAS ALARMS (Anesthetic Agents Alarm Limit) Menu ............................................... 6-3
LIST OF TABLES
Table Number Page Number
4-1 Agent Display During Mixed Agent Conditions ........................................................... 4-22
4-2 Agent Display During Mixed Agent Conditions .......................................................... 4-23
6-1 Alarm Limit Factory Default Settings ............................................................................. 6-7
6-2 Range of Alarm Limits .................................................................................................... 6-8
EQUIPMENT CLASSIFICATION
Classification according to IEC-60601-1
According to the type of protection against
electrical shock:
Class I equipment.
According to the degree of protection against
electrical shock:
Type CF (defibrillator-proof) equipment.
According to the degree of protection against
harmful ingress of water:
Ordinary equipment (enclosed equipment
without protection against ingress of water).
According to the methods of sterilization or
disinfection:
Non-sterilizable. Use of liquid surface
disinfectants only.
According to the mode of operation: Continuous operation.
Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with
oxygen or nitrous oxide.

vi
Precautions
General
Federal law in the USA or Canada restricts this device to sale by, or on, the order of a physician.
The accuracy of the measurements can be affected by the position of the patient, the patient’s
physiological condition, and other factors. Always consult a physician for interpretation of
measurements made by this monitor.
To avoid monitor fall, secure monitor on the shelf or bracket prior to use.
An explosion hazard exists if this monitor is used in the presence of flammable anesthetics.
The operator should read and thoroughly understand this manual completely before attempting to
operate the 3160 MRI Physiological Monitoring System.
If any system failure occurs (e.g. an unexplained continuous audible alarm) remove the monitor
from use, and refer it to qualified service personnel.
When an “X” appears in the Alarm Bell symbol, the audible alarm tone will not sound for any
reason.
Perform operational checkout before each use. If monitor fails to function properly, refer to
qualified service personnel.
For safe and accurate operation, use only recommended Invivo patient cable, lead wires, cuffs,
hoses, sensors, tubing, etc. A listing of these can be found in the Accessory Listing within this
manual, or by contacting Invivo directly.
For continued operation, always connect the monitor to AC Main Power when a Low Battery
indication occurs. Failure to do this can lead to interruption of monitoring and/or damage to the
monitor’s battery(s).
The system may not conform to all performance specifications if stored or used outside the
environmental specifications identified in Appendix A in the rear of this manual.
Do not apply any unnecessary pressure to the screen area of the monitor. Severe pressure applied
to this portion of the monitor could result in damage or failure of this screen.
All equipment not complying with IEC 60601-1 should be placed outside the patient
environment. Only connect IEC 60601-1 compliant equipment to this monitor. To avoid
potentially hazardous leakage currents, always check the summation of leakage currents when
several items of equipment are interconnected.
For proper equipment maintenance, perform the service procedures at the recommended intervals
as described in the monitor’s service manual.
Single use devices should never be reused.
Organic vapors (e.g. from cleaning agents) in sampling line or room air may alter anesthetic agent
readings.
Alcohol in patient's breath may modify the anesthetic agent readings.

vii
Precautions
Electrical Safety
To avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it with liquid
cleaning agents. Always disconnect monitor from AC Main Power before performing cleaning or
maintenance.
If monitor becomes accidentally wet during use, discontinue operation of the monitor until all
affected components have been cleaned and permitted to dry completely. Contact your local
Invivo representative if additional information is required.
Shock hazard exists if operated without chassis cover. Refer servicing to qualified service
personnel only.
For continued protection against fire hazard, replace fuses with same type and rating only.
Connect the monitor 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.
Avoid use of electrical power extension cords. Electrical power extension cords may create a
safety hazard by compromising the grounding integrity of the monitor.
None of the monitor interconnection ports on the rear of the monitor (e.g. Communication Ports,
Auxiliary Input/Output port [AUX I/O], ECG Sync Input [ECG SYNC IN], Keyboard or Video
Input) are intended for direct patient connection. An electric shock hazard can exist if the patient
is electrically connected to any of these connections.
This monitor and its listed accessories may be safely powered by the voltages 110-120/220-240
VAC having a frequency of 50 or 60 Hz.
If the integrity of the earth ground conductor of the AC mains power cable is in doubt, operate the
monitor on internal battery power until proper earth ground connection is confirmed.
Patient Safety
Constant attention by a qualified individual is needed whenever a patient is under anesthesia or
connected to a ventilator. Some equipment malfunctions may occur in spite of equipment or
monitor alarms.
Always test sampling line adapter for a tight connection and proper operation before attaching to
a patient.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
Occupational Safety
Connect the sample gas outlet on the monitor's rear panel to a scavenging system to prevent
pollution of room air.
Handle the Patient Sampling Line and its contents as you would any body fluid. Infectious hazard
may be present.
MRI Use Precautions
Certain components of this device will be affected by the magnetic and radio frequency fields present
in your MRI System. Confer with your MRI physicist and/or Radiology staff to identify the proper
placement and use areas for the monitor and its accessories, as defined on the monitor or accessory
labeling. Failure to properly place the monitor and its accessories in the Magnet Room will result in
monitor failure, and possible patient or user injury. Always position the 3160 MRI Physiological
Monitoring System at, or outside, the 5000 Gauss (0.5T) field line of the MRI system. A slight
distortion of the MRI magnetic field homogeneity or possible damage to either the monitor's NIBP or
EtCO2 pump could occur.

viii
Precautions
MRI Use Precautions (Continued)
Always verify proper communicationof the 3160 MRI Physiological Monitoring System with
the Remote Monitor prior to patient use.
MRI Magnet Room Placement. The 3160 MRI Physiological Monitoring System is designed to be
used in conjunction with a remote monitor. The 3160 MRI Physiological Monitoring System is
specially designed not to interfere with MRI operations and may be used inside the MRI Magnet Room
in any location at or outside the 5000 Gauss (0.5T) Field Line of the MRI System. If brought closer
than the 5000 Gauss Field Line, the NIBP monitor pump and EtCO2 pump may fail to operate.
The Remote Monitor is also specifically designed not to interfere with MRI operations, and may be
used in the Magnet Room at or outside the 1000 Gauss (0.1T) Field Line of the MRI System. If
brought closer than the 1000 Gauss Field Line, monitor damage (failure to operate) may result.
Risk of RF current burn. Cables which become inadvertently looped during MRI act as conductive
lines for RF induced currents. When lead wires or other cables form a conductive loop in contact with
the patient's tissue, minor to severe burning can result.
Perform the following to minimize risk of RF current burn:
a. Place cables and lead wires neatly in straight alignment with no looping.
b. Keep the length of lead wires and patient cable within the bore to a minimum.
c. RF burn risk increases when multiple sensors/cables are in use. Such combinations are
not recommended.
d. The high radio frequency (RF) power used in MRI scanning poses an ever-present risk
of excessive heat at the monitoring sites and, therefore, the risk of RF current burn.
Should power levels greater than S.A.R. of 4 w/kg peak (0.4 w/kg average) be
used, the risk of patient burn greatly increases. As a result, monitoring of ECG at
power levels of greater than 4 w/kg peak (0.4 w/kg average) is not recommended for
the general patient population. Such monitoring should only be attempted on conscious
patients with good temperature reflex so they may warn the operator of excessive heat
at the monitoring sites.
e. High RF Power may cause patient heating or burns. For scans with average S.A.R. > 1
w/kg, limit scan time to 5 minutes and pause at least 3 minutes between scans to allow
ECG Cable to cool.
MRI Compatibility
The Quadtrode®MRI ECG Electrode Pad, and ECG Patient Lead Wires and Cable, are compatible
with Magnetic Resonance Imaging (MRI) Systems within the following guidelines:
• MRI systems with static magnetic field strengths up to 1.5 Tesla.
• Usable within the MRI system bore with Specific Absorption Ratios (S.A.R.'s) up to 4.0 w/kg
(peak). Use with higher S.A.R.'s greatly increases the risk of patient burns.
• Non-Magnetic materials are used in the construction of these assemblies.
• If scanned directly across the plane of the ECG electrode element, a slight image distortion may
be seen at the skin surface where the electrode element is positioned.

ix
Precautions
ECG
An inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneous
Lead Fail alarm.
For best ECG, Heart Rate, S-T Segment, and/or Respiration monitoring, always select the
optimum lead configuration which has the least artifact and largest waveform(s) being detected
for monitoring use.
Failure to respond to a Lead Fail alarm will cause a lapse in your patient’s monitoring. Always
respond promptly to this and any other alarms.
Heart rate values may be adversely affected by cardiac arrhythmia, or by operation of electrical
stimulators.
NIBP
Always use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuff
hose.
When using the NIBP portion of this instrument to measure blood pressure, remember that the
patient’s blood pressure readings are not continuous, but are updated each time a blood pressure
measurement is taken. Set a shorter interval for more frequent updating of the patient’s blood
pressure.
Do not attach the cuff to a limb being used for infusion. Cuff inflation can block infusion, possibly
causing harm to the patient.
Frequent NIBP measurements can cause pooling of the blood in the limb (hemostasis), and
peripheral tissue/nerve damage. Allow sufficient time between measurements for blood
recirculation to prevent pooling of the blood in the limb.
Arrhythmic and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions)
can result in inaccurate readings and/or prolonged measurements. If questionable readings are
obtained, re-check patient’s vital signs by alternate means before administering medication.
To prevent possible nerve damage to the limb, apply the NIBP cuff as recommended by current
American Heart Association (AHA) guidelines for blood pressure monitoring.
To ensure accurate and reliable measurements, use only recommended patient cuffs/hoses. For
best accuracy, use the appropriate cuff size for each patient as recommended by the current AHA
guidelines for blood pressure monitoring.
Always tighten the cuff air hose connections snugly into place for proper operation.
Some reusable NIBP cuffs contain a medical-grade latex rubber. Patients sensitized to latex
rubber can have an allergic reaction when exposed to this material. Avoid the use of cuffs which
contain latex rubber on patients who are allergic to this material.
Routinely inspect the cuff and hose assemblies for proper attachment and orientation. Replace
cuff and/or hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the
system. If cuff and/or hose assemblies with damage which could result in leaks are used,
prolonged and/or inaccurate patient readings could result.
To prevent skin abrasion, apply and remove cuff carefully. Keep Velcro®(hook and latch)
retention areas away from the skin.

x
Precautions
SpO2
Avoid placement of the SpO2 sensor on the same limb with an inflated blood pressure cuff. Cuff
inflation could result in inaccurate readings and false alarm violations.
SpO2 monitoring requires the detection of valid pulses to correctly determine SpO2 and Heart
Rate values. During conditions of gross artifact, or in the absence of valid pulses, the SpO2 /rate
values may not be correct.
The SpO2 monitoring portion of this monitor is intended to measure arterial hemoglobin oxygen
saturation of functional hemoglobin (saturation of hemoglobin functionally available for
transporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such as
carboxyhemoglobin or methemoglobin, may affect the accuracy of the measurement. Also,
Cardiogreen and other intravascular dyes may, depending on their concentration, affect the
accuracy of the SpO2 measurement.
Always shield the SpO2 sensor from extraneous incident light sources. Such extraneous light can
cause SpO2 reading or pulse detection errors.
Frequently inspect the SpO2 sensor site for possible pressure tissue necrosis during prolonged
monitoring. Reposition the sensor at least every four (4) hours. Special care should be exercised
when tape is used to secure the sensor, as the stretch memory properties of most tapes can easily
apply unintended pressure to the sensor site.
The numeric measurement values are updated every one (1) second on the monitor display.
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.
The pulse oximeter feature in this monitor is designed to display functional SpO2 values.
The pulse oximeter pulsatile waveform is not proportional to the pulse volume, but adjusts the
waveform amplitude as needed for proper viewing.
All monitor alarms are categorized as medium priority, unless otherwise specified.
Arrhythmic and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions)
can result in inaccurate readings and/or prolonged measurements. If questionable readings are
obtained, re-check patient’s vital signs by alternate means before administering medication.
Respiration
When setting up respiration monitoring, always observe and adjust the respiration gain of the
monitor while watching the patient’s breathing efforts before completing selection of the gain
setting. Failure to do this can result in inaccurate readings, or false respiration detection.
End-tidal CO2 (EtCO2)
Verify that the patient’s breathing efforts and timing coincide with the monitor’s waveform before
completion of the patient set-up.
The EtCO2/N2O measurements are automatically pressure compensated over an ambient pressure
range from 576 to 788 mmHg.
The EtCO2/N2O measurement displays the sampled value within 1 second of when the gas was
sampled.
The alarm tone volume exceeds 60 dBA at a distance of 1 meter when the alarm tone volume
adjustment is set above selection number 8.
Frequently inspect the EtCO2 patient tubing for proper gas flow. Avoid kinking of the EtCO2
patient tubing that can result in leaking, reduction, or cut-off of the sample gas flow. Inaccurate gas
measurements could result.

xi
Precautions
End-Tidal CO2 (Continued)
EtCO2 patient tubing and its associated components are intended for single-patient use only.
Avoid cleaning or disinfecting these items for reuse. Inaccurate gas measurements could result.
To prevent inaccurate or missed readings, keep the EtCO2 patient tubing clear of any moving
mechanisms which may kink, cut or dislodge the patient tubing.
Do not overtighten the patient gas sample line to the water trap connector. Overtightening this
connector can cause failure of the water trap assembly and resultant inaccurate (artificially low)
patient gas measurements.
Avoid connecting the EtCO2 calibration gas canister to the monitor by any method other than
with the designated calibration tubing. Connecting by any other method could invalidate the
calibration, and/or damage the monitor.
Respiration rate measurement errors could result during ventilation rates above 80 breaths per
minute.
Anesthetic Agents
Inadequate ventilation of the monitor may cause inaccurate readings or damage to electronic
components.
Ensure that the exhaust gas is not removed from the monitor under too strong a vacuum. To
prevent this condition, there must always be an opening to the room air. Too high a vacuum level
may change the operating pressure of the monitor and cause inaccurate readings or internal
damage.
Inspect waste gas line for deterioration on a regular basis. Replace as needed.
Remove sampling line from patient airway whenever nebulized medications are being delivered.
Use only Invivo sampling lines and accessories; other sampling lines may cause inaccurate
readings and malfunctions.
Some Hydrocarbons (e.g. Acetone, Methane) may cause a mixed agent alarm to occur.
Replace the sampling line and inspect water trap between each patient use.
Do not overtighten the patient gas sample line to the water trap connector. Overtightening this
connector can cause failure of the water trap assembly and resultant inaccurate (artificially low)
patient gas measurements.
Routinely inspect the hose assemblies for proper attachment and orientation. Replace hose
assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. If hose
assemblies with damage which could result in leaks are used, prolonged and/or inaccurate patient
readings could result.
If questionable anesthetic agent gas measurements are observed, recheck patient connections,
anesthesia gas machine and/or vaporizer before re-adjusting anesthesia delivery.
Routinely verify the monitor’s internal barometric pressure reading with local conditions during
the initial start-up period.

xii
Precautions
Anesthetic Agents (Continued)
With no gas reading (Agent Icon box with white X for agent identification and agent values of “--
-”) when Agent Vaporizer is first turned on, it may take 30 seconds to 1.5 minutes for agent
identification and reading to be displayed. Once identification is established, changes in
concentration are virtually immediate. With a 200% change in concentration, an auto Zero will
occur, and full accuracy of the changed concentration will be accomplished within approximately
30 seconds.
Whenever the 3160 MRI Physiological Monitoring System Agent sensor changes from steady state
condition, the 3160 MRI Physiological Monitoring System will perform an auto zero to restabilize
the sensor readings. During this time, 15 seconds to 1.5 minutes, it is possible for a false
identification and concentration value to occur. Examples are as follows:
a. No gas, during warm-up and when sample line is disconnected.
b. Applying sample line for the first time.
c. When switching from one Agent to another.
d. Applying N2O in concentrations of 70% or more.
e. Going from N2O of greater than 50% to 0%.
f. When going from high Agent concentrations to low or off.
Other
This product, or any of its parts, should not be repaired other than in accordance with written
instructions provided by Invivo, or altered without prior written approval of Invivo Corporation.
The user of this product shall have the sole responsibility for any malfunction which results from
improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than
Invivo, or its authorized service personnel.
This monitor is equipped with a demonstration mode which displays simulated electronic patient
data for training or demonstration purposes. Do not attach a patient to the monitor whenever this
simulation is present on the monitor display (“SIMULATION” can also be seen in the screen
center). Failure to properly monitor the patient could result.
The patient connector inputs for all parameters are protected against the use of a defibrillator by
internal circuitry, and when the recommended patient cables or accessories are used. The use of
this circuitry and these recommended cables and accessories also protects against the hazards
resulting from use of high frequency surgical equipment.
There are no known electromagnetic or other hazardous interference between the monitor and
other devices. However, care should be taken to avoid the use of cellular phones or other
unintended radio-frequency transmitters in the proximity of the monitoring system.
This monitor uses rechargeable batteries which contain hazardous material, which must be
recycled, or disposed of properly. For proper disposal methods, contact your local Invivo
representative or distributor.
Avoid ammonia, phenol or acetone based cleaners for they may damage the monitor surface.
Dispose of the monitor and parts thereof according to local regulations.

xiii
Precautions
Other (Continued)
Notes, Cautions and Warnings. In the body of the manual notes, cautions and warnings are as
shown below to make them stand out on the page. The following is a description of the format and
meaning of Notes, Cautions and Warnings:
a. Notes. Notes are presented as shown below. Notes contain supplemental information
which Invivo has deemed especially important.
b. Cautions. Cautions are presented as shown below. Cautions are used for the words
and/or terms which alert the user to the possibility of a problem with the device
associated with its use or misuse. Such problems may include device malfunctions,
device failure, damage to the device or damage to other property.
c. Warnings. Warnings are presented as shown below. Warnings are used for the words
and/or terms which alert the user to possible injury, death or other serious adverse
reactions associated with the use or misuse of the device.
NOTE
This is a sample note.
CAUTION
This is a sample caution.
WARNING
This is a sample warning.

xiv
USER RESPONSIBILITY
This product will perform in conformity with the description contained in this operators manual
and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in
accordance with the instructions provided. This product must be checked and calibrated
periodically. A malfunctioning product should not be used. Parts that are broken, missing, plainly
worn, distorted or contaminated should be replaced immediately. Should such repair or
replacement become necessary refer unit to qualified service personnel. This product or any of its
parts should not be repaired other than in accordance with written instructions provided by the
manufacturer, or altered without written approval of Invivo. The user of the product shall have the
sole responsibility for any malfunction which results from improper use, faulty maintenance,
improper repair, damage or alteration by anyone other than Invivo or Invivo authorized service
personnel.
Using this Manual. Whenever the various options are discussed, “XXX” is used to indicate a
variable setting. It is required that every operator read this manual completely, including any
patient information in sections about monitoring features the operators monitor does not have,
before attempting to operate the 3160 MRI Physiological Monitoring System.
The figures contained in this manual show a fully equipped monitor. Therefore, figures within
this manual may depict monitoring features that your monitor may not contain. For information
on features and enhancements that are not contained on your monitor, contact Invivo at (407) 275-
3220.
Precautions (listed earlier in this section) cover of wide ranges of information crucial to the safe
monitoring of patients. It is required that every operator read the PRECAUTIONS completely,
including the Precautions associated with monitoring features that the operators monitor does not
have, before attempting to operate the 3160 MRI Physiological Monitoring System.
This device is covered under one or more of the following U.S. Patents: 5,482,036; 5,490,505;
5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830;
6,157,850; 6,277,081 and international equivalents. U.S.A. and international patents pending.
Possession or purchase of this device does not convey any express or implied license to use the
device with replacement parts which would, alone, or in combination with this device, fall within
the scope of one or more of the patents relating to this device.
For further information or assistance with this product:
Invivo Corporation
407-275-3220 or 800-331-3220

xv
3160 MRI Physiological Monitor Accessories
ECG
Item Description Part Number
Quadtrode®MRI ECG Electrodes, 50/box .......................................................................................9303N
MRI ECG Patient Lead Wire Set..........................................................................................................9218
ECG/EEG Skin Prep Gel, 1 tube 4 ounce ............................................................................................9009
Non-Invasive Blood Pressure
Reusable BP Cuffs and Hoses
Twin-Lumen Adult Air Hose (18 ft. length) .................................................................................... 9010M
Single-Lumen Neonatal NIBP Air Hose (18 ft. length) ............................................................... 9010NM
Infant MRI BP Cuff......................................................................................................................9050MNL
Pediatric MRI BP Cuff .................................................................................................................9060MNL
Adult Standard MRI BP Cuff.......................................................................................................9070MNL
Adult Large Arm MRI BP Cuff ...................................................................................................9080MNL
Adult Thigh MRI BP Cuff ...........................................................................................................9090MNL
Disposable BP Cuffs
Neonatal NIBP Cuff, Disposable, Size A, Velcro........................................................................ AN01AV
Neonatal NIBP Cuff, Disposable, Size B, Velcro ........................................................................ AN02AV
Neonatal NIBP Cuff, Disposable, Size C, Velcro ........................................................................ AN03AV
End-Tidal CO2
EtCO2 Sampling Kit...........................................................................................................................9010D
Contains 20 foot co-extruded sampling tube polyethylene inner core with PVC jacket, Nafion®
tube, elbow adapter and 0.8 micron disk filter.
Adult EtCO2 Cannula ...........................................................................................................................9012
Pediatric EtCO2 Cannula ......................................................................................................................9013
SpO2
Spare Wireless Pulse Oximeter Module............................................................................................... 9311
SpO2 Grip Sensor............................................................................................................................... 9399B