Trionara 06 UM Pac T3 E211128

Trionara Technologies AB.
User Manual
Pac T3
Wearable Patient Care Monitor
TD000330-06
1984
TRIONARA TECHNOLOGIES AB
Trionara Technologies AB
Polygonvägen 21.
18766. Täby. Sweden.
Tel: +46-31-135514
Web site: www.trionara.com
Email: info@trionara.com
This manual is an integral part of the product and describes its intended use. Observance of the
manual is a prerequisite for proper product performance and correct operation and ensures patient
and operator safety.
Note:
 The warranty does not cover damages resulting from the use of accessories and consumables
from other manufacturers.
 Trionara Technologies AB. is responsible for the effects on safety, reliability, and performance
of the product, only if:
 Assembly, operations, extensions, readjustments, modifications, or repairs are carried out
by persons authorized by Trionara Technologies AB.
 The device is used in accordance with the instructions for use
 Due to continuing product innovation, specifications in this manual are subject to change
without notice.
Manual Purpose
This manual contains the instructions necessary to operate the Pac T3 Wearable Patient Care
Monitor safely and in accordance with its functions and intended use.
Intended Audience
This manual is provided for the clinical medical professionals. Clinical medical professionals are
expected to have working knowledge of medical terminology and procedures as required for
patient monitoring.
Caution
For continued safe use of this equipment, it is necessary that the listed instructions be followed.
However, instructions listed in this manual in no way supersede established medical practices
concerning patient care.
Conventions
 Warning: Directions that warn of conditions that put the patient or the caregiver at risk.
 Caution: Directions that help to avoid damaging the monitor or losing data.
 Note: Directions that make it easier to use the monitor, something not readily apparent.
 Figures: All illustrations in this manual are provided as examples only. They may not
necessarily reflect your monitoring setup or data displayed on your monitor.
Version Information
This manual has a version number. The version number changes whenever the manual is updated
due to software or technical specification changes. The version information of this manual is as
follows.
Release date Version number
November 2021 TD000330-06
Read this manual carefully before patient use of the monitor.
Trionara Technologies AB. reserves the right to make changes to this manual and improvements
to the product it describes at any time without notice or obligation.
All rights reserved. No part of this manual may be reproduced without the written permission of
Trionara Technologies AB.
Contents
Chapter 1 General Information ................................................................................................ 1-1
Safety........................................................................................................................................ 1-1
Intended Use of Product ........................................................................................................... 1-1
Symbols used in Pac T3 Monitor ............................................................................................. 1-3
Installation and Setup ............................................................................................................... 1-4
General Warnings ..................................................................................................................... 1-4
Environmental conditions ........................................................................................................ 1-6
Chapter 2 System Configuration .............................................................................................. 2-1
Introduction .............................................................................................................................. 2-1
Getting Started.......................................................................................................................... 2-3
Turn On ................................................................................................................................ 2-3
Turn Off ................................................................................................................................ 2-3
Lock Mode ............................................................................................................................... 2-4
Front Panel Functional keys ..................................................................................................... 2-5
Main Page................................................................................................................................. 2-7
Connecting the Accessories ..................................................................................................... 2-8
Battery Operation ..................................................................................................................... 2-8
Battery Status ........................................................................................................................... 2-9
Charger ..................................................................................................................................... 2-9
Connecting to Wi-Fi Status ................................................................................................ 2-10
Chapter 3 Alarms ....................................................................................................................... 3-1
Introduction .............................................................................................................................. 3-1

Physiological alarms ................................................................................................................ 3-1
Manifestation of Patient Alarms........................................................................................... 3-1
Technical alarms ...................................................................................................................... 3-2
Manifestation of Equipment Alarms .................................................................................... 3-2
Messages .................................................................................................................................. 3-2
Manifestation of Messages ................................................................................................... 3-2
Alarm Level and Setup ............................................................................................................. 3-3
Alarm Modes ........................................................................................................................ 3-3
Display Screen ...................................................................................................................... 3-3
Alarm Indicator ........................................................................................................................ 3-3
Audio Alarm ......................................................................................................................... 3-4
Alarm verification ................................................................................................................ 3-4
Alarm Silence Button Function ................................................................................................ 3-4
Chapter 4 ECG ........................................................................................................................... 4-1
Introduction .............................................................................................................................. 4-1
Safety........................................................................................................................................ 4-3
Preparations .............................................................................................................................. 4-3
Skin Preparation ................................................................................................................... 4-4
ECG 3-lead electrode placement .......................................................................................... 4-5
ECG 6-lead electrode placement .......................................................................................... 4-6
Normal QRS waveform ........................................................................................................ 4-7
ECG Appearance ...................................................................................................................... 4-7
Freeze ................................................................................................................................... 4-8
ECG MENU ............................................................................................................................. 4-8
ECG Lead ........................................................................................................................... 4-10

Lead Type ........................................................................................................................... 4-11
HR Source .......................................................................................................................... 4-12
HR Alarm ........................................................................................................................... 4-13
HR Alarm Level ................................................................................................................. 4-14
HR Alarm Limit ................................................................................................................. 4-14
ECG Filter .......................................................................................................................... 4-15
Pace Detect ......................................................................................................................... 4-16
Sweep ................................................................................................................................. 4-17
Chapter 5 Respiration ............................................................................................................... 5-1
Respiration Monitoring ............................................................................................................ 5-1
Electrode Placement for Respiration .................................................................................... 5-1
Checklist for RESP Monitoring ........................................................................................... 5-1
Respiration Appearance ........................................................................................................... 5-1
RESP MENU............................................................................................................................ 5-2
Resp Lead ............................................................................................................................. 5-3
RR Alarm ............................................................................................................................. 5-3
RR Alarm Level ................................................................................................................... 5-4
RR Alarm Limit.................................................................................................................... 5-4
Apnea.................................................................................................................................... 5-5
Chapter 6 SpO2 .......................................................................................................................... 6-1
Introduction .............................................................................................................................. 6-1
Signal Extraction Technology (SET) ....................................................................................... 6-5
SPO2 Measurement .................................................................................................................. 6-6
SPO2 Signal and Parameter Area............................................................................................. 6-7
General Description for pulse oximetry measurement: ........................................................ 6-7

% SPO2 ................................................................................................................................ 6-7
Pulse rate .............................................................................................................................. 6-8
Perfusion Index..................................................................................................................... 6-8
Pleth Variability Index ......................................................................................................... 6-9
SPO2 Appearance .................................................................................................................... 6-9
SPO2 MENU ............................................................................................................................ 6-9
Average Time ..................................................................................................................... 6-10
Sensitivity ........................................................................................................................... 6-11
Fast SAT ............................................................................................................................. 6-12
SPO2 Alarm ....................................................................................................................... 6-13
SPO2 Alarm Level ............................................................................................................. 6-14
SPO2 Alarm Limit.............................................................................................................. 6-15
SPO2 page .............................................................................................................................. 6-15
PULSE RATE MENU ........................................................................................................... 6-16
PR Alarm ............................................................................................................................ 6-17
PR Alarm Level .................................................................................................................. 6-18
PR Alarm Limit .................................................................................................................. 6-19
Chapter 7 Setting Menu ............................................................................................................ 7-1
Access to Setting Menu ............................................................................................................ 7-1
Mode......................................................................................................................................... 7-2
Factory Settings ........................................................................................................................ 7-3
Alarm........................................................................................................................................ 7-3
Alarm Buzzer ....................................................................................................................... 7-3
Alarm LED ........................................................................................................................... 7-4
Alarm Review....................................................................................................................... 7-5

Display ..................................................................................................................................... 7-5
Display Time Out ................................................................................................................. 7-6
Lock Time Out ..................................................................................................................... 7-7
Brightness ............................................................................................................................. 7-8
Display Off ........................................................................................................................... 7-9
Display Lock ........................................................................................................................ 7-9
Patient ....................................................................................................................................... 7-9
Gender ................................................................................................................................ 7-10
Age Cat ............................................................................................................................... 7-11
Blood .................................................................................................................................. 7-11
Patient Discharge ................................................................................................................ 7-12
Setup ....................................................................................................................................... 7-13
Time.................................................................................................................................... 7-13
Date .................................................................................................................................... 7-14
Factory Reset ...................................................................................................................... 7-15
About .................................................................................................................................. 7-15
Param Trend ....................................................................................................................... 7-16
Chapter 8 Archive ...................................................................................................................... 8-1
Alarm Review .......................................................................................................................... 8-1
Param Trend ............................................................................................................................. 8-2
Chapter 9 Mobile Application .................................................................................................. 9-3
Introduction .............................................................................................................................. 9-3
Setup and Initial settings .......................................................................................................... 9-3
Connecting the Monitor to Application ................................................................................... 9-4
Application User Manual ......................................................................................................... 9-6

Chapter 10 Accessories .......................................................................................................... 10-14
ECG Accessories .................................................................................................................. 10-14
SPO2 (MASIMO) Accessories ............................................................................................ 10-14
Battery .................................................................................................................................. 10-15
Chapter 11 Care and Cleaning ............................................................................................... 11-1
System Check ......................................................................................................................... 11-1
Cleaning and disinfection ....................................................................................................... 11-2
External surfaces ................................................................................................................ 11-2
Display screen .................................................................................................................... 11-3
Accessories ......................................................................................................................... 11-3
Preventive Maintenance (PM) ................................................................................................ 11-6
Chapter 12 Troubleshooting ................................................................................................... 12-1
Chapter 13 Technical Specifications ...................................................................................... 13-1
Chapter 14 Messages and Alarms .......................................................................................... 14-1
Physiological Alarms ............................................................................................................. 14-1
Technical Alarms ................................................................................................................... 14-3
Appendix I EMC
Chapter 1 General Information
Safety
The following Warnings, Cautions and Notes have to be obeyed to guaranty a safe operation of
the monitor. Additional Warnings, Cautions and Notes, which apply to specific parameters, are
listed in the related sections for each parameter.
The Patient Monitor is designed to comply with the international safety standard requirements for
medical electrical equipment. This device has floating inputs and is protected against the effects
of defibrillation and ESU. If the correct electrodes are used and applied in accordance with the
manufacturer instructions, the screen display will recover within 10 seconds after defibrillation.
Intended Use of Product
Pac T3 which is defined as a wearable healthcare device, plays a portable vital sign monitoring
device roles for vast range of users. For example, post ICU patients, after hospital patient, high
risk person at home or their work place can use the Pac T3 to monitor their real time vital sign
situations.
Pac T3 is able to work in 3-wire or 6-wire state to measurement and continuously monitor a
patient’s ECG, heartrate (HR), functional arterial oxygen saturation (SPO2) and respiration rate
(RR).
The purpose of Pac T3 patient monitors is monitoring of patient vital signs and they are intended
to be in continuous use for long term.
These active medical devices are not invasive and implantable.
Patient monitor is intended for clinical monitoring application with operation only granted to the
competent medical staff.
 Target Population (intended user)

Pac T3 wearable patient care monitor is intended for use on adult (over twelve), pediatric
(from three to twelve) and neonatal (from birth to age three) patients in the care of health
care professionals
1-1
 Intended Use Environment (use place)
Pac T3 wearable patient care monitors can be used in medical care centers such as ER,
recovery wards, Post CCU and NICU.
 Indications, Contraindications
There is not any Indications, Contraindications for patient, but:
 ECG electrodes are contraindicated for use on patients with limited skin access or
allergic reaction to electrode adhesive or application gel.
 Reusable ECG electrodes are contraindicated for use for prolonged periods of use. It
is not intended for long term monitoring. Electrodes must be removed and
repositioned if indicated by skin integrity, and reapplied to a different monitoring
site.
 Respiration monitoring is contraindicated for patients who are receiving high
frequency ventilation assistance.
 Reusable SPO2 sensors are contraindicated for use for prolonged periods of use. It is
not intended for long term monitoring. It must be removed and repositioned every
four (4) hours and if indicated by circulatory condition or skin integrity, reapplied to
a different monitoring site.
 Disposable SPO2 sensors are contraindicated for patients that exhibit allergic
reactions to adhesive tape. The sensors must be removed and repositioned every
eight (8) hours and if indicated by circulatory condition or skin integrity, reapplied to
a different monitoring site.
 No other contraindications are known at this time
 Side Effects
There are not any side effects.
1-2
Symbols used in Pac T3 Monitor
Protected from tools and wires greater than 2.5 millimeters.

1
Protected from water spray less than 15 degrees from vertical. IP32
2 Manufacturer address
Consult operator’s manual: Refer to the operator’s manual for

complete information. This label on the device points the user to the
3 operator’s manual for complete information. In the operator’s manual,
this symbol cross-references the label.
Dispose according to Council Directive 2012/19/EUor WEEE (Waste

Electrical and Electronic Equipment):
4
This symbol indicates that the equipment shall be disposed of in an
environmentally-friendly manner.
5 Manufacture Date
6 Serial Number SN
7 CE sign & NB identification number
DEFIBRILLATION-PROOF TYPE BF APPLIED PART:

This symbol indicates that the monitor has CF type and Defibrillation
Proof applied part according to IEC60601-1. The modules with this
8
symbol contain a CF-Type isolated (Cardiac Float) patient applied
part providing a high degree of protection against shock, and is usable
during defibrillation.
Caution sign: This symbol beside the patient connector indicates that
a part of protection against effects of defibrillator is provided by the
9
accessory connected to patient. Therefore, use only accessories
approved by the manufacturer.
Wireless connection
10
1-3
Installation and Setup
The Pac T3 monitor is used as a portable monitor that provides the possibility of monitoring the
patient vital signs in the different places and situations. This monitor is hanged to the patient's neck
with a neck strap along with the device and after connecting the corresponding electrodes, monitors
his vital signs. Data transmission on the central system at the nurse station or on the tablet is
possible with the Wi-Fi network.
Since the Pac T3 monitor continuously monitors the patient vital signs, it is hanged to the patient
neck and transferred with him during the awaking time and placed next to him during the sleep
and rest time.
General Warnings
 Warning: The monitor is not intended for diagnostic use. The health care professional should
seek a full capability ECG system for diagnostic purposes.
 Warning: The Pac T3 Monitor is intended only as an adjunct in patient assessment. It must be
used in conjunction with clinical signs and symptoms.
 Warning: Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level during patient monitoring may result in a hazard to
1-4
the patient. Remember that the most reliable method of patient monitoring combines close
personal surveillance with correct operation of monitoring equipment.
 Warning: Do not use the Pac T3 monitor for any purpose other than specified in this
manual. Doing so will invalidate the monitor’s warranty.
 Warning: Do not connect more than one patient to a monitor. Do not connect more than one
monitor to a patient.
 Warning: Do not use the Pac T3 monitor for Open Heart Applications (Intra-cardiac
Application).
 Warning: The Pac T3 monitor is not intended to be used in Oxygen Enriched Atmospheres.
 Warning: Do not use the monitor in the presence of Magnetic Resonance Imaging (MRI)
equipment.
 Warning: Explosion Hazard - Do not use the monitor in the presence of a flammable
Anesthetic Mixture with Air or with Oxygen or Nitrous Oxide.
 Warning: Explosion Hazard - Do not use this equipment in the presence of flammable
anesthetics, vapors or liquids.
 Warning: Electromagnetic Compatibility (EMC) - The equipment needs special precautions
if it is placed close to a strong transmitter such as X-ray equipment, MRI devices, TV, AM/FM
radios, police/fire stations, a HAM radio operator, an airport, or cellular phone. Their Signals
could interfere with the monitor, which may result in disruption of performance of this device
or prevents the clear reception of signals by the monitor.
 Warning: There will be some risks of polluting the environment associated with the disposal
of the device and cables at the end of their useful lives. The device and accessories shall be
disposed in accordance with national laws after their useful lives. Contact your municipality
to check where you can safely dispose of old batteries.
 Caution: Qualified biomedical engineering personnel only must interface monitoring
equipment with other types of medical equipment. Be certain to consult manufacturers’
specifications to maintain safe operation.
 Caution: Measurements may be affected in the presence of strong electromagnetic sources
such as electro surgery equipment.
 Note: The Pac T3 monitor is designed for continuous operation.
1-5
 Note: The monitor has been designed to promote patient safety. All equipment parts are
protected against the effects of the discharge of a defibrillator. No separate actions are required
when using this equipment with a defibrillator.
 Warning: When using a defibrillator, parameters and signals will be temporarily interrupted
until electroshock is finished.
 Warning: To avoid device malfunction, liquids must not be allowed to enter the device. If
liquids have entered a device, take it out of service and have it checked by a service technician
before it is used again.
 Warning: Do not gas sterilize or autoclave the monitor.
 Warning: Route all cables away from patient’s throat to avoid possible strangulation.
 Warning: There could be hazard of electrical shock by the monitor casing. To avoid risk of
electric shock, this equipment must only be connected to a mains supply with protective earth.
 Caution: Pressing the touch or membrane keys with a sharp or pointed instrument may
permanently damage the switch membrane. Press the keys using only your finger.
Environmental conditions
Magnetic and electric fields may interfere with the monitor, so make sure the electric devices
around the monitor meet relevant EMC requirements. Listed below are some warnings but
not limited to:
 The Pac T3 is intended for use in the electromagnetic environment specified in Appendix
I, in the EMC Declaration section. The customer or the user of the Pac T3, should assure
that it is used in the mentioned environment.
 Keep the monitor and the pulse oximeter away from the presence of Magnetic Resonance
Imaging (MRI) equipment.
 Keep the monitor away from the presence of a flammable Anesthetic Mixture with Air or
with Oxygen or Nitrous Oxide.
 Do not use this equipment in the presence of flammable anesthetics, vapors or liquids.
1-6
 Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic
radiation emitted from such devices may result in strong interference with the monitor
performance.
 Electromagnetic Compatibility (EMC) - The equipment needs special precautions if it is
placed close to a strong transmitter such as X-ray equipment, MRI devices, TV, AM/FM
radios, police/fire stations, a HAM radio operator, an airport, or cellular phone. Their
Signals could interfere with the monitor, which may result in disruption of performance of
this device or prevents the clear reception of signals by the monitor.
 To access information about operating and storage and transport temperature and humidity,
refer to technical specification chapter.
1-7
Chapter 2 System Configuration
Introduction
The Pac T3 Wearable Patient Care Monitor is a pre-configured monitor that will provide you with
the following vital signals and parameters:
 ECG Heart Rate (HR), Arrhythmias, ECG waveforms

 RESP Respiratory Rate (RR), Respiration Waveform
 SPO2 Saturation pulse oximetery (SpO2), Pulse Rate (PR), SpO2 Plethysmogram
Both, the ECG signal and the respiratory signal (based on the thorax impedance change) are
measured through the same set of ECG electrodes. The user can select ECG lead related to a 3-
wire or a 6-wire (optional) patient cable. The following figures demonstrate the monitor’s
appearance from different views.
Figure 2-1: PAC T3 monitor front view
2-1
Figure 2-2: Pac T3 monitor rear view
Figure 2-3: Pac T3 monitor top view
Figure 2-4: Pac T3 monitor side view
2-2
Getting Started
Turn On
Press and hold the POWER key on the side panel for 5 seconds to turn the monitor on (Figure
2-5).
Turn Off
When the monitor is not being used, by pressing the POWER key for 5 seconds the message
“Device will be ShutDown, Are You Sure?” will be shown. If selected YES, the display will turn
blank and the unit is no longer monitoring the patient.
Figure 2-5: Side panel keys
2-3
Figure 2-6: Power off
Lock Mode
The touch screen of Pac T3 monitor will be locked and inactive by selecting the “Display Lock”
option in the display section of the setting. When “Display Lock” option is selected, the Lock
indicator is shown in the upper-right corner of display page. For canceling the lock mode, power
key should be pressed once, and the Lock indicator will be disappeared from the screen. For further
information about the “Display Lock” option, refer to chapter 7.
Figure 2-7: Lock Mode
2-4
Front Panel Functional keys
The monitor can be operated via the front panel touch buttons (Figure 2-8) and touch screen.
Figure 2-8: Front panel
 Page Key : The Page Key is used for switching between the pages.
Note: At the moment the Pac T3 monitor has three pages that the first page is portrait and the
second and third pages are landscape. The third page is SPO2 page.
2-5
Figure 2-9: Portrait page
Figure 2-10: Landscape page
Figure 2-11: SPO2 page
2-6
 Setting Key: The Setting key is used for entering to the device Setting Menu.
 Back Key: The Back key is used for returning to the last menu.
Main Page
The main display contains the following sections:
1. Status Bar
Time, bed number, Battery indicator, Alarm Silence indicator, Wi-Fi indicator, Frozen indicator
and Lock indicator can be observed in the status bar.
 Note: When the Alarm Silence key is pressed, (figure 2-5) the alarm silence indicator
appears in this section.
 Note: By touching the left-end of ECG signal for 5 second, the FROZEN message appears
in this section and all waveforms will be frozen.
2. Technical Alarm Bar
3. Physiological Alarm Bar
4. Parameters area
 The upper-left parameter is HR. (Heart Rate)
 The upper-right parameter is SPO2.
 The lower-left parameter is RR. (Respiration Rate)
 The lower-right parameter is Temp. (This parameter will be active in the future.)
5. Waveforms
 ECG wave form
 SPO2 wave form
 Respiration wave form
2-7
Connecting the Accessories
The various accessories are connected to the appropriate input connectors in the upper part of the
monitor.
In the upper part of the monitor, the ECG/Respiration, SPO2 and USB connectors are placed from
left to right respectively.
 ECG/Respiration connector: Is used for ECG cable connection
 SPO2 connector: Is used for the connection of Masimo pulse oximetry probe and extension
 USB connector: At the moment this connector is placed only to the authorized trained
personnel of Trionara Technologies AB. and used to upgrading the device software or
saving the device information on the computer.
Battery Operation
The Pac T3 monitor is working with 2 AA Disposable or Rechargeable Batteries. The

Manufacturer suggests using of 2 NI-MH batteries which have high capacity, and are
environmentally friendly.
The device is working about 24 continues hours in telemetry mode, which sends ECG signals to
the central device and with turned off monitor, by means of 2 AA, 2400 mAh batteries. Working
time is different according to device setting and selected battery types.
To insert the batteries into the monitor, follow these steps.
1- Open the Battery Container by pulling its handle back (Figure 2-12).
2- Bring the container out of the monitor's case.
3- Insert the batteries into the container by being concerned about the "+" and "-" signs, which
show the right direction of each battery.
4-Put the batteries' container back into its location in monitor and make sure that it has been locked
correctly.
2-8
 Warning: The device will not work, if the batteries are not inserted correctly; however, this
fault will not harm the monitor.
Figure 2-12: Battery Operation
Battery Status
The battery level is displayed using the battery indicator .
This indicator informs the user about the amount of battery charge in 5 levels include full charge,
%75, %50, %25 and under %5. In two levels %25 and under %5, the Low Battery alarm is issued.
Charger
A USB charger (charging head and USB cable) is included with the device for charging the battery.
For charging the battery using the charger, follow the instructions below.
1. Connect the USB cable to the charging head, and then plug the charging head into a
standard outlet.
2. Insert the USB cable into the charger port of the device.
3. The green LED near the charging port indicates that the device is being charged.
4. Unplug the charging head from the outlet and remove the USB cable from the device when
charging is complete.
2-9
Figure 2-13: Charger
 Caution: Use only charging devices and batteries approved by Trionara Technologies AB.
Connecting to Wi-Fi Status
If the device is set on Central or Tablet mode, the Wi-Fi indicator is shown in white and after
connecting the Wearable Patient Care Monitor to the network, the indicator color changes from
white to green.
2-10
Chapter 3 Alarms
Introduction
Alarms can be classified into three categories: Physiological alarms, Technical alarms and
messages.
The Pac T3 Monitor distinguishes between physiological and technical alarms and messages.
 Warning: Always verify the audible and visible alarms when monitor is powered on.
 Warning: Alarm settings including priority, limits and volume should be done with regard to
the patient and environment conditions in a way that the patient life is not threatened and
reoccurrence of alarms is prevented.
Physiological alarms
Physiological alarms also called patient alarms are triggered by a parameter value that violates
adjusted alarm limits or an abnormal patient condition.
 Warning: Before each use, verify that the alarm limits are appropriate for the patient being
monitored.
 Note: All patient alarms, based on continuously monitored parameters (e.g. Heart Rate, SpO2,
etc.) will clear automatically when the alarm cause is no longer persistent.
 Note: To access physiological alarm list, refer to chapter 13.
Manifestation of Patient Alarms
 Numeric display of the alarming parameter flashes.

 Alarm LED’s are activated.
 Audible tone is generated. (The tone is appropriate to the alarm level.)
 Flashing text in physiological alarm’s bar explains the cause.
 Note: When an ongoing patient alarm is acknowledged by pressing the ALARM SILENCE
key, all alarms, except the alarm label on display, will be suspended for 2 minutes or until
the time of happening a new alarm.
3-1
 Note: The delay time from an alarm occurrence to alarm manifestation (parameter blinking,
alarm message, alarm sound) is less than 1 second. (Delay time of APNEA alarm is
corresponding to APNEA LIMIT setting in RESP menu.)
Technical alarms
Technical alarms also called equipment alarms are triggered by a device malfunction or a patient
data distortion due to improper operation or mechanical problems.
 Note: All equipment alarms will clear automatically when the alarm cause is no longer
persistent.
 Note: To access technical alarm list, refer to chapter 13.
Manifestation of Equipment Alarms
 Alarming parameter display flashes.

 Alarm LED’s are activated.
 Audible tone is generated. (The tone is appropriate to the alarm level.)
 Flashing text in technical alarm’s bar explains the cause.
 Note: When an ongoing patient alarm is acknowledged by pressing the ALARMSILENCE

key, all alarms, except the alarm label on display, will be suspended for 2 minutes or until the
time of happening a new alarm.
Messages
In fact, prompt messages are not alarm messages. In addition to physiological and technical alarm
messages, the patient monitor displays some messages indicating the system status. All messages
are displayed in the Message Area.
 Note: To access Message list, refer to chapter 13.
Manifestation of Messages
 Flashing text in the message area explains the cause.
3-2
Alarm Level and Setup
PAC T3 Monitor has three levels of alarm.
 Level I: alarm indicates the patient's life is in danger or the monitor under use has serious
problems. It is the most serious alarm.
 Level II: alarm means serious warning.
 Level III: alarm is a general warning.
Pac T3 monitor has preset the alarm level for the parameters. You can also modify alarm level of
each module in its own window. Refer to the settings section for each parameter to learn how to
configure settings.
Alarm Modes
Alarm messages, LEDs and sounds are designed in such a manner that can be recognizable by the
operator from a distance of 1 m.
Display Screen
When an alarm is triggered by a parameter, the parameter value will blink on the screen and alarm
message with regard to its level will be displayed in different backgrounds.
 Level I alarm message: Red background – White text

 Level II alarm message: Yellow background – Black text
 Level III alarm message: Cyan background – Black text
 Note: If the monitor displays an informative message, the background will change to gray.
Alarm Indicator
Alarm indicator flashes red for Level I alarm and yellow for Level II alarm and lights yellow for
Level III alarm.
3-3
Audio Alarm
Corresponding alarm sound will be activated, if the alarm is not silent (i.e., the ALARM SILENCE
button has not been pressed).
The audio alarms are activated with three levels.
 Level I alarm sounds "DO-DO-DO--DO-DO" every 10 seconds;

 Level II alarm sounds "DO- DO-DO" every 20 seconds;
 Level III alarm sounds "DO-" every 30 seconds.
The alarm sound pressure in front of the monitor and at the distance of 1m is 54 dB(A).
 Note: When alarms of different levels occur at the same time, the alarm LED prompts the
alarm of the highest level (red color) and the other alarms are displayed alternately in a
background color corresponding to their levels.
 Note: If two or more alarms of the same level occur simultaneously, the alarm messages will
be displayed alternately.
Alarm verification
Every time the monitor turns on, a buzz sound is heard and blue, orange and red indicators light
respectively. The indicators turn off after the monitor powers on completely. If no buzzer sound
is heard or no alarm indicator lights, do not use the monitoring system on any patient and notify
After Sales Service.
Alarm Silence Button Function
ALARM SILENCE feature provides a distinct advantage of suspending all alarms, except the
alarm label on display, for 2 minutes or until the time of happening a new alarm. If within the 2
minutes of alarm suspension the operator presses "Alarm Silence" button, the alarm suspension
status will be ended and the normal alarm status resumed immediately.
3-4
Chapter 4 ECG
Introduction
Both, the ECG signal and the respiratory signal (based on the thorax impedance change) are
measured through the same set of ECG electrodes. The user can select ECG lead related to a 3-
wire or a 6-wire (optional) patient cable.
The Pac T3 monitor determines respiration by impedance pneumography. The monitor detects
changes in thoracic impedance that occur as a result in chest movements. Impedance normally
increases with inspiration and decreases with expiration. Respiration detection is based on an
inspiration and an expiration.
Through ECG monitoring you can see a continuous waveform of the patient's cardiac electric
activity which enables physician to perform a precise assessment of patient current physiological
condition. The process of depolarization and repolarization of the myocardium generates an
electric potential that are sensed by ECG electrodes on the skin.
These electrodes are typically attached to the patient's right arm, left arm and left leg. The monitor
processes and amplifies this signal and displays it as ECG waveform on the screen. Proper
connection of the ECG cables and electrodes can ensure accurate assessment.
 In order to calculate HR Average, heart rate is sent to averaging section every second and
based on the user setting the calculated average value is displayed.
 The time of changing or updating the heart rate in the PAC T3monitor with regard to HR
Average in every eight seconds is as below.
 To change HR from 80 to 120 bpm: 4 sec
 To change HR from 80 to 40 bpm: 10 sec
The above results are for lead II.
 When Tachycardia (HR>120 bpm) happens, it takes 6 seconds to activate alarm sound by
the system. (If low alarm limit is adjusted 60 bpm and high alarm limit 100 bpm).
4-1
 It takes 10 seconds to activate alarm sound by the system when a cardiac arrest happens.
(from 80 bpm to 0 bpm)
 The ECG module is able to reject 1.2 mV TALL-T.
 The current that is applied to the patient for lead-sensing is 90nA.
 Noise suppression circuit: A noise signal of 10 µA is given reversely to the reference lead.
 According to IEC60601-2-27:2011 standard, the measured heart rates for irregular signals
are as follows.
Irregular rhythm HR (bpm)- adult HR (bpm)- pediatric HR (bpm)- neonate

ventricular bigeminy 70-80 70-80 70-80
slow alternating 30 30 67
ventricular bigeminy
rapid alternating 126 126 126

ventricular bigeminy
bidirectional systoles 60-97 60-97 93-117
normal, Gain: 1, Sweep speed: 25, Lead II
 The ECG patient cable consists of 2 parts: The cable that is connected to the monitor and
the lead set that is connected to the patient.
 Warning: When you connect the cables and electrodes, make sure that no metal part of
electrodes is in contact with the safety ground. Check that all ECG electrodes are correctly
attached to the patient.
 Warning: Before monitoring check ECG cable to ensure that there are no signs of damage.
Do not use scratched or ripped cables or the cables with flexed lead wires.
 Note: Interference from devices near the patient like electrosurgical units can cause
inaccurate ECG waveform.
 Warning: Make sure that ECG cable is not under tension during monitoring.
 Warning: Select the patient mode carefully, because QRS detection thresholds and HR
measurement algorithm are different in Neonatal and Adult modes.
 Warning: Do not touch patient, monitor and bed during defibrillation.
4-2
 Warning: Use only manufacturer recommended ECG cable for monitoring. Other ECG
cables and leads may cause improper system performance and decrease safety during
defibrillation.
 Warning: ECG cable may be damaged if it is connected to the patient during defibrillation.
Cables which have been connected to the patient during defibrillation should be checked
functionally before being used again.
 Note: If ECG waveform is not accurate while the electrodes are properly attached, try to
change the lead.
Safety
 Warning: If uncertain about the accuracy of any measurement, check the patient’s vital
signs by alternate means and then make sure the monitor is functioning correctly.
 Warning: The monitor is not detecting arrhythmias and is not alarming on irregular ECG
rhythms.
 Caution: ECG electrodes are contraindicated for use on patients with limited skin access or
allergic reaction to electrode adhesive or application gel.
 Caution: Reusable ECG electrodes are contraindicated for use for prolonged periods of use.
It is not intended for long term monitoring. Electrodes must be removed and repositioned if
indicated by skin integrity, and reapplied to a different monitoring site.
 Caution: Do not rely on the ECG waveforms for any diagnostic purposes.
 Warning: Verify the cable fault detection prior to monitoring. Unplug the ECG cable from
the socket, the monitor will display the error message "ECG NO CABLE" on the screen.
 Warning: When using Electrosurgery equipment, leads should be placed in a long distance
from the grounding plate and electrosurgical pencil to prevent unwanted burns.
 Warning: Patient burning is possible due to improper connection of the grounding plate of
the electrosurgical unit.
Preparations
 Caution: Prior to patient monitoring, ensure the monitor is configured to the appropriate
patient mode (Neonate, Pediatric or Adult). Refer to paragraph “Age Cat” in chapter 7.
4-3
 Note: The quality of ECG information is a direct result of the quality of the electrical signal
received at the electrode.
 Note: Proper skin preparation is necessary for good signal quality at the electrode. A good
signal at the electrode provides the monitor with valid information for processing the ECG
data.
 Note: Always check the Date Code of the electrodes prior to applying them to the patient.
 Note: Do not use the 6-Lead Patient Cable for 3-Lead monitoring. A “Leads OFF” message
would be displayed.
Skin Preparation
The following is a suggested guideline for skin preparation and should be followed for all electrode
types.
 Choose flat, non-muscular areas to place electrodes.

 Make sure the skin area where the electrodes are to be placed is clean, dry, intact and free
of powder, oil or lotion.
 If necessary, shave hair from skin at chosen sites.
 Place chest leads on the proper place on the patient. If your chest lead has not conductive
gel, apply some conductive gel on intended site of the skin.
 Attach the clips or snaps to the chest leads before placing them.
 Warning: Use only one type of electrode on the same patient to avoid variations in electrical
resistance. For ECG monitoring, it is recommended to use silver/silver chloride electrode.
When dissimilar metals are used for different electrodes, the electrodes may cause large
offset potentials due to polarization which it can cause problems with ECG waveform. Using
dissimilar metals may also increase recovery time after defibrillation.
 Warning: Do not touch the patient, bed, table nearby or the monitor during defibrillation.
 Warning: Use only the recommended manufacturer ECG cable for monitoring. Other ECG
cables and leads may cause improper performance and/or reduce protection during
defibrillation.
4-4
Figure 4-1:ECG 3-lead electrode placement
ECG 3-lead electrode placement
 Right arm (RA): red electrode, near the right shoulder, directly below the clavicle.
 Left Arm (LA): yellow electrode, near the left shoulder, directly below the clavicle.
 Left Leg (LL): green electrode, on the left hypogastrium.
Figure 4-2: ECG 6-lead electrode placement
4-5
ECG 6-lead electrode placement
 Right arm (RA): red electrode, near the right shoulder, directly below the clavicle.
 Left Arm (LA): yellow electrode, near the left shoulder, directly below the clavicle.
 Left Leg (LL): green electrode, on the left hypogastrium.
 Right Leg (RL): black electrode, on the right hypogastrium.
 Chest (Vx): The placements are shown in the figure 4-2.
For ECG 6-lead set, the Vx electrode can be placed on one of the following positions on the
chest:
 V1 on the fourth intercostal space at the right sternal border.

 V2 on the fourth intercostal space at the left sternal border.
 V3 midway between V2 and V4 electrode positions.
 V4 on the fifth intercostal space at the left midclavicular line.
 V5 on the left anterior axillary line, horizontal with V4 electrode.
 V6 on the left middle axillary line, horizontal with V4 electrode.
 V3R-V6R on the right side of the chest in positions corresponding to those on the left.
 VE over the xiphoid position.
For posterior lead placement, place the Vx electrode at one of the following positions:
 V7 on posterior chest at the left posterior axillary line in the fifth

intercostal space.
 V7R on posterior chest at the right posterior axillary line in the fifth
intercostal space.
 Note: To ensure the patient safety, all leads must be attached to the patient.
 Note: The lead which is used for Pace and HR is the main lead.
 Note: The voltage of signal amplitude in leads II and V is higher than other leads.
4-6
Depending on lead type (3-lead wire or 6-lead wire), you can choose different leads including I,
II, III, aVR, aVL, aVF and Vx.
Figure 4-3: ECG leads
Normal QRS waveform
 Tall R-wave completely above or below the baseline.

 T -wave less than one-third of the R-wave height.
 P-wave much smaller than the T -wave.
Figure 4-4: Standard ECG waveform
ECG Appearance
 ECG waveform is displayed in green.

 The main lead name is displayed in green on the left side of the signal.
 The selected ECG filter is displayed in green at the top of the signal.
 The pacemaker detection is displayed at the top right of the signal. If pacemaker is enabled,
“PaceOn” will be shown in white, and if disabled, “PaceOff” will be shown in green.
4-7
 The gain index is displayed in the right corner of the signal in white (or red). Touching the
bar will change the gain among x/8, x/4, x/2, x, 2x values. When the bar color turns to red,
it means that gain selector is in automatic status and it will choose the best signal to display.
 Gain is in automatic mode when the device turns on.
Freeze
To prevent from signal movement (in order to have a fixed signal) press on the left corner of the
signal; the area which the main lead name of ECG signal is displayed. The “Frozen” message
will be shown in Status Bar. For leaving this mode press on the main lead name of ECG signal
again.
Figure 4-6: Frozen
ECG MENU
By pressing on the HR parameter area (Figure 4-7), ECG MENU will pop up (Figure 4-8) and you
can reach following items:
4-8
Figure 4-7: HR parameter area
 ECG Lead
 Lead Type
 HR Source
 HR Alarm
 ECG Filter
 Notch Filter
 Pace Detect
 Sweep
Figure 4-8: ECG MENU
4-9
ECG Lead
To adjust ECG Lead, follow the instruction below:
Note: This menu is inactivated, if the ECG cable is not connected to the device.
 Press the HR parameter area (Figure 4-7) and select ECG Lead.
 Available options are Lead I, Lead II, Lead III, Lead V2, Lead V5, Lead AVR, Lead
AVL, Lead AVF. Default setting for this item is Lead II.
 Choose the item you wish.
 By pressing OK, the changes will be saved and the main page is shown.
Available options for adjusting the ECG Leads are:
"І" to count the heart rate and show RA-LA waveform
"ІІ" to count the heart rate and show RA-LL waveform
"ІІІ" to count the heart rate and show LA-LL waveform
LA  LL
"aVR" to count the heart rate and show RA- waveform
2
4-10
RA  LL
"aVL"to count the heart rate and show LA- waveform
2
RA  LA
"aVF" to count the heart rate and show LL- waveform
2
RA  LA  LL
"Vx" to count the heart rate and show Vx- waveform
3
 Depending on the lead type (3-Wires or 6-Wires), you can choose different leads I, II, III,
aVR, aVL, aVF and V2 and V5.
 Lead I, lead II, lead III are selectable for 3-Wires lead type.
 Lead I, lead II, lead III, lead V2, lead V5, lead AVR, lead AVL, lead AVF are
selectable for 6-Wires lead type.
Lead Type
To adjust Lead Type, follow the instruction below:
 Press the HR parameter area (Figure 4-7) and select Lead Type.
 Available options are 3-Wires and 6-Wires. Default setting for this item is 3-Wires.
 By pressing OK, the changes will be saved.
4-11
HR Source
To adjust HR source, follow the instruction below:
 Press the HR parameter area (Figure 4-7) and select HR source.

 Available options are Auto, ECG and SPO2. Default setting for this item is Auto.
Available options for adjusting the heart rate source (HR Source) are:
4-12
 ECG: By selecting this item, the heart rate is derived from ECG signal and it will be shown
in green.
 SPO2: By selecting this item, the heart rate is derived from SPO2 signal and it will be
shown in purple.
 Auto: By selecting this item, the heart rate may be derived from “ECG” or “SpO2” signals.
 Note: If two or more signals are being monitored simultaneously, the heart rate derivation
will be done based on the signals priority, i.e. the heart rate will be derived respectively
from ECG and then SpO2.
HR Alarm
To adjust HR Alarm, follow the instruction below:
 Press the HR parameter area (Figure 4-7) and select HR Alarm.

Available options are On and Off. Pick "ON" to enable alarm functions such as
parameters blinking, audio alarm and light indicator. Pick "OFF" to disable the HR alarm
functions and there will be a " " symbol in the HR Parameter Area. Default setting for
this item is Off.
4-13
HR Alarm Level
To adjust HR Alarm Level, follow the instruction below:
 Press the HR parameter area (Figure 4-7) and select HR Alarm Level.
 Available options are 1,2 and 3. Default setting for this item is 1. Level 1 represents the
most serious case.
HR Alarm Limit
ECG alarm is activated when the heart rate exceeds adjusted MAX value or falls below adjusted
MIN value. To adjust HR Alarm Limit, follow the instruction below:
 Press the HR parameter area (Figure 4-7), and select HR Alarm Limit.
 Min and Max values are selectable from 30 to 300. Default setting for this item is 50-120.
4-14
ECG Filter
To adjust ECG Filter, follow the instruction below:
 Press the HR parameter area (Figure 4-7) and select ECG Filter.
 Available options are Monitor, Normal, Extended. Default setting for this item is Extended.
 Use the following table for clearer and more detailed waveform.
4-15
FILTER TYPE FREQUENCY RANGES APPLICATION
NORMAL 0.5-40HZ In normal use.
In diagnostic application. but the ECG
EXTENDED 0.05-100HZ waveform might have some noises
This mode may reduce interference from

Electrosurgery equipment or can be used
MONITOR 0.5-24HZ
when the system has high noises or doesn't
have equipotential earth.
Also, The Notch filter by default has been set on 50 Hz and it’s not possible to change it. Notch
filter is automatically deactivated when the Pace Detection is ON.
Pace Detect
To adjust Pace Detect, follow the instruction below:
 Press the HR parameter area (Figure 4-7) and select Pace Detect.
 Available options are On and Off. Default setting for this item is Off.
4-16
 When the Pacemaker Detection is enabled and a pacemaker impulse is detected, an artificial
spike is added to the ECG waveform.
 The Pace Detect item should be "ON" for patient with Pacemaker and" OFF" for patient
without Pacemaker. When PACE DETECT is "ON", the ECG monitoring system detects
and rejects Pacemaker-generated signals from ECG signal so that they will be ignored in
determining heart rate. Detected Pacemaker signals will be marked on the ECG waveform
as 1 centimeter spike. Monitoring of patients with Pacemaker is not generally affected when
PACE DETECT is enabled. However, in some instances if the patient does not have a
Pacemaker, it may be desirable to turn the detection function OFF so that artifacts in the
waveform will not be mistaken for a Pacemaker signal.
 NOTE: ECG signals with the slope of up to 1 V/s will not be counted as Pace signal.
 NOTE: Ineffectively Paced QRS beside atrial Pace pulses which precede ventricular Paces
by 150 ms to 250 ms will be rejected in addition to normal Pace pulses.
 Warning: For patients with Pacemaker, PACE DETECT must be switched "ON", otherwise,
the Pace pulses may affect HR counting and result in low precision of HR value.
 For the patients with Pacemaker, the monitor may continue to count the Pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon monitor alarms.
Keep the patients with Pacemaker under close surveillance.
Sweep
In this section, making change in the sweep (the recording speed) of the SPO2 and ECG signals
between "12.5 mm/s" and "25 mm/s" is possible. To adjust Sweep follow the instruction below:
 Press the Setting option enter the password, press Ok and select Sweep.
 Available options are 12.5 and 25(mm/sec). Default setting for this item is 12.5.
4-17
4-18
Chapter 5 Respiration
Respiration Monitoring
Several considerations have to be made when the patient’s respiration is monitored:
Electrode Placement for Respiration
Electrode placement is crucial to monitoring respiration by the impedance method. The sensitivity
of the monitor and its ability to accurately detect respiration is greatly enhanced or impeded by the
quality of the electrodes and optimal electrode placement.
 Note: The respiration signal is received from the LA/L and RA/R electrodes. These leads are
available on 3-lead and 5-lead cables.
Observe the patient and place the electrodes where the greatest breathing movement occurs on the
chest.
Checklist for RESP Monitoring
1. Prepare the patient's skin prior to placing the electrodes.
2. Attach the electrodes to the patient and attach snap or clip to the electrodes.
3. Switch on the monitor.
Note: Place the red and green electrodes diagonally to optimize the respiration waveform. Avoid
the liver area and the ventricles of the heart in the line between the RESP electrodes to prevent
cardiac overlay or artifacts from pulsating blood flow. This is particularly important for neonates.
Respiration Appearance
 Respiration waveform is displayed in yellow.

 The main lead name is displayed in yellow on the left side of the signal.
5-1
 The Respiration rate parameter (RR) is also displayed in yellow.
RESP MENU
By pressing on the RR parameter area, (Figure 5-1) RESP MENU will pop up (Figure 5-2) and
you can reach following items:
Figure 5-1: RR parameter area
 Resp Lead
 RR Alarm
 RR Alarm Level
 RR Alarm Limit
 Apnea
Figure 5-2: RESP MENU
5-2
Resp Lead
To adjust Resp Lead, follow the instruction below:

Note: in 3-wire mode the Resp lead will be chosen automatically.
 Press the RR parameter area (Figure 5-1) and select Resp Lead.
 Available options are RA-LA and RA-LL. Default setting for this item is RA-LA.
RR Alarm
To adjust RR Alarm, follow the instruction below:
 Press the RR parameter area (Figure 5-1) and select RR Alarm.

 Available options are On and Off. Default setting for this item is Off. Pick "ON" to enable
RR alarm functions such as parameters blinking, audio alarm, and light indicator. Pick
"OFF" to disable the alarm functions and there will be a " " symbol in the RR
Parameter Area. Default setting for this item is Off.
5-3
RR Alarm Level
To adjust RR Alarm Level, follow the instruction below:
 Press the RR parameter area (Figure 5-1) and select RR Alarm Level.
 Available options are 1,2 and 3. Default setting for this item is 1. Level 1 represents the
most serious case.
RR Alarm Limit
Respiration alarm is activated when the respiration rate exceeds adjusted MAX value or falls
below adjusted MIN value. To adjust RR Alarm Limit, follow the instruction below:
5-4
 Press the RR parameter area (Figure 5-1) and select RR Alarm Limit.
Apnea
Apnea alarm is activated to set the standard of judging an apnea case. To adjust Apnea, follow
the instruction below:
 Press the RR parameter area (Figure 5-1) and select Apnea.

 Available options are Off, 10sec, 15sec, 20sec, 25sec, 30sec, 35sec and 40sec. Default
setting for this item is 10sec.
5-5
 Note: Apnea alarm is always enabled with level 1 and ON/OFF status of RR alarm has not
any effect on it.
5-6
Chapter 6 SpO2
Introduction
Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial
oxygen saturation in blood. The pulse oximetry system of this monitor has been design as an
external module and includes the following:
1. uSPO2 cable
2. Sensor
3. Pac T3 monitoring system
The external SPO2 cable is a patient cable with an integrated pulse oximetry board. The sensor is
connected to the uSPO2 cable due to collecting signal data from the patient and sending it to the
board for calculating parameters. Finally, the Pac T3 monitor just displays signal waveform and
parameters. This module is designed and provide by Masimo Company and submitted to its
approved companies.
 Note: For Masimo patent information, please refer to the following address:
“https://www.masimo.com/patents/”
 Note: No Implied License Statement: “Possession or purchase of this device does not convey
any express 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.”
 Warning: The pulse oximeter is to be operated by, or under the supervision of, qualified
personnel only. The manual, accessories, directions for use, all precautionary information, and
specifications should be read before use.
 Warning: The pulse oximeter should not be used as the sole basis for medical decisions. It
must be used in conjunction with clinical signs and symptoms.
 Warning: Use only the recommended manufacturer SPO2 sensor for monitoring. Other SPO2
sensors may cause monitor malfunction, thus operator is responsible to select an appropriate
sensor before use.
 Warning: Do not use the pulse oximeter if it appears or is suspected to be damaged.
6-1
 Warning: Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an
MRI environment.
 Warning: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
 Warning: Do not place the pulse oximeter or accessories in any position that might cause it to
fall on the patient.
 Warning: Do not start or operate the pulse oximeter unless the setup was verified to be correct.
 Warning: To ensure safety, avoid stacking multiple devices or placing anything on the device
during operation.
 Warning: To protect against injury, follow the directions below:
 Avoid placing the device on surfaces with visible liquid spills.
 Do not soak or immerse the device in liquids.
 Do not attempt to sterilize the device.
 Use cleaning solutions only as instructed in this operator's manual.
 Do not attempt to clean the device while monitoring a patient.
 Warning: To protect from electric shock, always remove the sensor and completely disconnect
the pulse oximeter before bathing the patient.
 Warning: The pulse oximeter is not an apnea monitor.
 Warning: The pulse oximeter should not be used for arrhythmia analysis.
 Warning: The pulse oximeter may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
 Warning: The pulse oximeter may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
 Warning: Explosion hazard: Do not use the pulse oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
 Warning: Do not adjust, repair, open, disassemble, or modify the pulse oximeter or
accessories. Injury to personnel or equipment damage could occur. Return the pulse oximeter
for servicing if necessary. Changes or modifications shall void the guaranty for the pulse co-
oximeter accessories.
6-2
 Warning: If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check the pulse oximeter for proper functioning.
 Warning: Prolonged and continuous monitoring may increase jeopardy of unexpected change
of dermal condition such as abnormal sensitivity, vesicle, repressive putrescence, and so on. It
is especially important to check the sensor placement of neonate and patient of poor perfusion.
Check per 2-3 hours the sensor placement and move it when the skin deteriorates. More
frequent examinations may be required for different patients.
 Warning: Tissue damage or inaccurate measurement can be caused by incorrect application
or use of an SPO2 sensor, for example by wrapping the sensor too tightly or by applying
supplemental tape.
 Warning: Loss of pulse signal can occur when
 The patient is in cardiac arrest or in shock.
 The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
 There is arterial occlusion proximal to the sensor.
 Warning: Inaccurate SPO2 readings may be caused by:
 Improper sensor application and placement
 Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a
seemingly normal SPO2. When elevated levels of COHb or MetHb are suspected,
laboratory analysis (CO-Oximetry) of a blood sample should be performed.
 Elevated levels of bilirubin
 Elevated levels of dyshemoglobin
 Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
 Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle
cell, etc.
 Hypocapnic or hypercapnic conditions
 Severe anemia
 Very low arterial perfusion
 Extreme motion artifact
 Abnormal venous pulsation or venous constriction
 Severe vasoconstriction or hypothermia
6-3
 Arterial catheters and intra-aortic balloon
 Intravascular dyes, such as indocyanine green or methylene blue
 Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.
 Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal
fingers. etc.
 Skin color disorders
 Warning: Interfering Substances: Dyes or any substance containing dyes that change usual
blood pigmentation may cause erroneous readings.
 Warning: SPO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
 Caution: If SPO2 values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
 Caution: Do not place the pulse oximeter where the controls can be changed by the patient.
 Caution: Electrical shock and flammability hazard: Before cleaning, always turn off the device
and disconnect from any power source.
 Caution: Do not place the pulse oximeter on electrical equipment that may affect the device,
preventing it from working properly.
 Caution: When patients are undergoing photodynamic therapy they may be sensitive to light
sources. Pulse oximetry may be used only under careful clinical supervision for short time
periods to minimize interference with photodynamic therapy.
 Caution: If “SPO2 LOW PERFUSION” message is frequently displayed, find a better
perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation
status through other means.
 Caution: Change the application site or replace the sensor when a “Replace Sensor”, or a
persistent poor signal quality message (such as “Low SIQ”) is displayed on the monitor. These
messages may indicate that patient monitoring time is exhausted on the patient sensor.
 Caution: If SPO2 values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
 Caution: If using pulse oximetry during full body irradiation, keep the sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the
instrument might read zero for the duration of the active irradiation period.
6-4
 Caution: Variation in measurements may be profound and may be affected by sampling
technique as well as the patient's physiological conditions. Any results exhibiting inconsistency
with the patient’s clinical status should be repeated and/or supplemented with additional test
data. Blood samples should be analyzed by laboratory instruments prior to clinical decision
making to completely understand the patient’s condition.
 Caution: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of
patient applied circuits and the system are within acceptable limits as specified by the
applicable safety standards. The summation of leakage currents must be checked and in
compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked
when connecting external equipment to the system. When an event such as a component drop
of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before
further use. Injury to personnel could occur.
 Caution: Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
 Caution: To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse oximeter.
 Caution: Replace the cable or sensor when a replace sensor or when a low SIQ message is
consistently displayed while monitoring consecutive patients after completing troubleshooting
steps listed in this manual.
 Note: A functional tester cannot be used to assess the accuracy of the pulse oximeter.
 Note: Do not loop the patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
 Note: Materials used in our SPO2 sensors are innoxious.
Signal Extraction Technology (SET)
Masimo (SET) signal processing differs from conventional pulse oximeters. Conventional pulse
oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site.
During patient motion, however, the venous blood also moves, causing conventional pulse
oximeters to read low values, because they cannot distinguish between the arterial and venous
blood movement (sometimes referred to as noise).
6-5
Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters
are powerful because they are able to adapt to the varying physiologic signals and/or separate them
by looking at the whole signal and breaking it down to its fundamental components. The Masimo
SET signal processing algorithm, Discrete Saturation Transform (DST), readily identifies the
noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen
saturation for display on the monitor.
SPO2 Measurement
Applying the sensor is as follows.

1. Turn on the monitor.
2. Attach the sensor to the appropriate site of the patient finger (Refer to Figure 6-1 for the proper
method).
3. Plug the connector of the sensor extension cable into the SPO2 socket on the top side of the
device.
Figure 6-1: SpO2 sensor placement
 Note: Make sure the nail covers the light window.

 Note: The wire should be on the backside of the hand.
 Note: Do not use the sensor on extremities with arterial catheter or venous syringe.
 Note: Do not perform SpO2 and NIBP measuring in same arm simultaneously; because
obstruction of blood flow during NIBP measuring may adversely affect the SpO2 value.
 Note: High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the pulse oximeter to obtain vital sign readings.
6-6
 Note: Additional information specific to the Masimo sensors compatible with the pulse
oximeter, including information about parameter/measurement performance during motion
and low perfusion, may be found in the sensor's directions for use (DFU).
 Note: sensors are provided with X-Cal™ technology to minimize the risk of inaccurate
readings and unanticipated loss of patient monitoring. Refer to the Sensor DFU for the
specified duration of the patient monitoring time.
SPO2 Signal and Parameter Area
The following items are displayed in SPO2 parameter area:
 The SPO2% value can be displayed on the main screen (main page) and SPO2%, PR, PI
and PVI values are displayed on the SPO2 page. The pleth waveform is displayed as
normalized waveform and its amplitude does not comply with real blood volume
variations.
 if "HR Source" is set to "SPO2", PR value will be displayed in purple color, otherwise it
will be displayed in green.
 User can be informed of inadequacy of signal and physiological parameters values by
various messages and alarms in necessary situations.
General Description for pulse oximetry measurement:
Pulse oximetry is governed by the following principles:

1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood) species
differ in their absorption of visible and infrared light.
2. The amount of arterial blood in tissue changes with your pulse (photoplethysography).
Therefore, the amount of light absorbed by the varying quantities of arterial blood changes
as well.
% SPO2
Extent of oxygen saturation in hemoglobin of arterial blood can be detected from the SPO2
waveform. For example, if 97% hemoglobin molecules in the red blood cells of the arterial
6-7
blood combine with oxygen, then the blood has an oxygen saturation of 97%. The SPO2
value on the monitor will be 97%. The SPO2 value shows the percentage of hemoglobin
molecules which have combined with oxygen molecules to form oxyhemoglobin.
O2 Hb
SPO2   100
O2 Hb  HHb
Pulse rate
PR indicates the Heart Rate per minute which SPO2 module extracts from the pulse
oximetry signal.
Perfusion Index
Perfusion index (PI) indicates arterial pulse signal strength as a ratio of pulsatile blood flow
to the non-pulsatile blood.
Perfusion Index enables you to choose the best position for sensor placement and value
greater than 1% is preferable.
AC
PI   100
DC
Figure 6-2: PI definition
6-8
Pleth Variability Index
This parameter is to measure dynamic changes in PI during the respiratory cycle which can
be extremely associated with intrathoracic pressure changes.
PVI can be a useful noninvasive monitoring method or an advanced indicator to detect
physiological changes of intrathoracic pressure. During one or two complete respiratory
cycle, PVI is calculated as follows:
𝑃𝐼𝑀𝑎𝑥 − 𝑃𝐼𝑀𝑖𝑛
𝑃𝑉𝐼 = × 100%
𝑃𝐼𝑀𝑎𝑥
PVI can help clinicians predict fluid responsiveness in patients.
SPO2 Appearance
 Pleth waveform is displayed in purple.

 The word “PLETH” is displayed in the bottom left of the signal in purple.
 The SPO2% value can be displayed on the main screen (main page) and SPO2%, PR, PI
and PVI values are displayed on the SpO2 page.
SPO2 MENU
By pressing on the SpO2% parameter area, (Figure 6-3) SPO2 MENU will pop up (Figure 6-4)
and you can reach following items:
Figure 6-3: SPO2 parameter area
6-9
 Average Time
 Sensitivity
 Fast SAT
 SPO2 Alarm
 SPO2 Alarm Level
 SPO2 Alarm Limit
Figure 6-4: SPO2 menu
Average Time
To adjust Average Time, follow the instruction below:
 Press the SPO2% parameter area, (Figure 6-3) and select Average Time.
 Available options are 2-4 sec, 4-6 sec, 8 sec, 10 sec, 12 sec, 14 sec and 16 sec. Default
setting for this item is 8sec.
6-10
Sensitivity
The sensitivity mode setting allows the clinician to adapt the SPO2 measurement sensitivity to the
patient’s level of SPO2 signal strength and quality at the measurement site. To adjust Sensitivity,
follow the instruction below:
 Press the SPO2% parameter area, (Figure 6-3) and select Sensitivity.
 Available options are Normal, APOD and MAX. Default setting for this item is Normal.
6-11
Available options for Sensitivity are as follows:
 Normal Sensitivity :The perfusion threshold has different limits as the perfusion calculation
is data dependent. Specially; there is an intelligent algorithm which adjusts the low perfusion
limit in accordance with the quality of the incoming plethysmography waveform between
0.5% and 0.02%. This mode provides the best combination of sensitivity and probe-off
detection performance. This mode is recommended for the majority of patients.
 Maximum Sensitivity (MAX) :Recognizing that some clinicians may want the absolute low
perfusion performance (0.02%) all of the time and may be willing to sacrifice sensor off
detection, Masimo provides a maximized sensitivity mode. This mode should be used for the
sickest patients, where obtaining a reading is most difficult. Maximum Sensitivity is
designed to interpret and display data for even the weakest of signals. This mode is
recommended during procedures and when clinician and patient contact is continuous. In
MAX mode, the message "SPO2 MAX SENS." displays on the screen with yellow color.
 Note: When using the Maximum Sensitivity setting, performance of the “Sensor Off”
detection may be compromised. If the instrument is in the setting and the sensor become
dislodged from the patient, the potential for false reading may occur due to environmental
“noise” such as light, vibration, and excessive air movement.
 Adaptive Probe Off Detection (APOD): This mode is not advisable for patients with low
perfusion because the system has the least sensitivity to signal changes in this mode. It is
used in situations having risk of probe detachment (e.g. children or uneasy patients). By
selecting this mode, “SPO2 APOD MODE” appears on the screen with yellow color.
Fast SAT
Fast SAT enables rapid response to, and display of, fast changes in SPO2 by giving priority to
the most recent data. This aids the clinician in clinical settings requiring fast response time such
as those seen with induction, intubation, sleep studies and resuscitation. To adjust Fast SAT,
 Press the SPO2% parameter area, (Figure 6-3) and select Fast SAT.
 Available options are Off and On. Default setting for this item is Off.
6-12
 Note: As a result of the increased fidelity of this mode, Fast Sat is not recommended for
routine use as there may be an increase of the frequency of alarms caused by rapid, transitory
SpO2 changes. When the Miniature III is set to Fast Sat On, the averaging algorithm
evaluates all the saturation values providing an averaged saturation value that is a better
representation of the patient’s current oxygenation status. With Fast Sat, the averaging time
is dependent on the input signal. Fast Sat is always on for 2-4 and 4-6 averaging modes, but
there is no message displayed that Fast Sat is on.
SPO2 Alarm
To adjust SPO2 Alarm, follow the instruction below:
 Press the SPO2% parameter area, (Figure 6-3) and select SPO2 Alarm.
 Available options are Off and On. Pick "ON" to enable SPO2 alarm functions such as
parameters blinking, audio alarm, and light indicator. Pick "OFF" to disable the alarm
functions and there will be a " " symbol in the SPO2% Parameter Area. Default
setting for this item is Off.
6-13
SPO2 Alarm Level
To adjust SPO2 Alarm Level, follow the instruction below:
 Press the SPO2% parameter area, (Figure 6-3) and select SPO2 Alarm.
Available options are 1 and 2. Default setting for this item is 1. Level 1 represents the
most serious case.
6-14
SPO2 Alarm Limit
SPO2 alarm is activated when the SPO2% exceeds adjusted MAX limit or falls below adjusted
MIN limit. To adjust SPO2 Alarm Limit, follow the instruction below:
 Press the SPO2% parameter area, (Figure 6-3) and select SPO2 Alarm Limit.
 Min and Max values are selectable from 1 to 99. Default setting for this item is 85.
SPO2 page
SPO2 page is available in Page 3 as Figure 6-5. In this page, PR is always extracted from SPO2
signal without considering selected HR source.
6-15
Figure 6-5: SPO2 Page
 Caution: To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time the pulse oximeter is used.
 Note: SPO2 module updates SPO2 and pulse rate values every 1 sec.
PULSE RATE MENU
By pressing on the PR parameter area (Figure 6-6) on SPO2 page, PULSE RATE MENU will pop
up (Figure 6-7) and you can reach following items:
Figure 6-6: SPO2 Page
 PR Alarm
 PR Alarm Level
 PR Alarm Limit
6-16
Figure 6-7: PULSE RATE MENU
PR Alarm
To adjust PR Alarm, follow the instruction below:

 Press the PR parameter area (Figure 6-6) on SPO2 page and select PR Alarm.
 Available options are Off and On. Pick "ON" to enable PR alarm functions such as
parameters blinking, audio alarm, and light indicator. Pick "OFF" to disable the alarm
functions and there will be a " " symbol in the PR Parameter Area. Default setting
for this item is Off.
By pressing OK, the changes will be saved.
6-17
PR Alarm Level
To adjust PR Alarm Level, follow the instruction below:
 Press the PR parameter area (Figure 6-6) on SPO2 page and select PR Alarm.
Available options are 1 and 2. Default setting for this item is 1. Level 1 represents the
most serious case.
6-18
PR Alarm Limit
PR alarm is activated when the PR exceeds adjusted MAX limit or falls below adjusted MIN limit.
To adjust PR Alarm Limit, follow the instruction below:
 Press the PR parameter area (Figure 6-6) on SPO2 page and select PR Alarm Limit.
6-19
Chapter 7 Setting Menu
Access to Setting Menu
For accessing to Setting Menu, follow the instruction bellow.
 While the device is on, press this indicator .

 Enter the password and press Ok. If you enter a wrong password the message “Invalid
Password: Try Again “will show up.
o Note: The required password for this section is “2020”.
 After entering the password, the Setting Menu shows up (Figure 7-1).
 Select and adjust the item you wish.
 Note: Battery run out or system turning off will not change device settings.
 The following items can be set through this menu:

 Mode
 Factory Settings
 Alarm
 Display
 Patient
 Setup
7-1
 Param Trend
 About
Figure 7-1: SETTING MENU
Mode
This option is used to set the monitoring mode on Monitor, Central or Tablet. To adjust Mode,
 Press the Setting option enter the password, press Ok and select Mode.
 Available options are Monitor, Central and Tablet. Default setting for this item is Monitor.
7-2
Factory Settings
 Note: At the moment, only manufacturer’s authorized personnel have access to this window
and it is used for the adjustments related to AP Name, AP Password, Bed Number and Demo.
Alarm
This section is to enable or disable the alarm notifications and having access to alarm review. To
adjust Alarm, follow the instruction below:
 Press the Setting option enter the password, press Ok and select Alarm.
 Available options are Alarm Buzzer, Alarm LED, Alarm Review.
Alarm Buzzer
This section is to enable or disable the audio alarm. To adjust Alarm Buzzer, follow the
instruction below:
 Press the Alarm Buzzer option.
7-3
 Available options are On and Off. Pick "ON" to enable the audio alarm. Pick "OFF" to
disable the audio alarm. Default setting for this item is On.
Alarm LED
This section is to enable or disable the LED light indicator. To adjust Alarm LED, follow the
instruction below:
 Press the Alarm LED.
 Available options are On and Off. Pick "ON" to enable the LED light indicator. Pick
"OFF" to disable the LED light indicator. Default setting for this item is On.
7-4
Alarm Review
By selecting Alarm Review, all the alarms related to HR, SPO2 and RR parameters and the date
and the time of alarm occurrence will be shown. Further information is accessible in chapter 8.
Display
This option is for adjusting the display brightness, enabling lock, turning off the display, adjusting
the time duration before display goes off and adjusting the time duration before lock goes off when
the device is idle. To adjust Display, follow the instruction below:
 Press the Setting option enter the password, press Ok and select Display.
 Available options are Display Time Out, Lock TimeOut, Brightness, Display Off and
Display Lock.
7-5
Display Time Out
The Pac T3 Monitor incorporates a display time out feature that, when enabled by user, turns
the display’s backlight automatically off after some minutes (based on the user-defined time).
To exit this mode, press the power button once. To adjust Display TimeOut, follow the
instruction below:
 Press the Display TimeOut option.
 Available options are Always On, 1 minute, 2 minute, 5 minute, 10 minute and 30
minute. Default setting for this item is 10 minute.
 When the display goes off, if “Alarm LED” is activated, the LED lights at the top of the
front panel, will notify ongoing alarms. Furthermore, if the “Alarm Silence” is activated, a
blue flashing LED at the top of the front panel, will be enabled for 120 seconds showing that
the monitor is On.
7-6
Lock Time Out
The Pac T3 Monitor incorporates a lock time out feature that, when enabled by user, the touch
screen of the monitor will be automatically locked and inactive after some minutes (based on the
user-defined time). The lock indicator is shown in the upper-right corner of display page. To adjust
Lock TimeOut, follow the instruction below:
 Press the Lock TimeOut option.
 Available options are Deactive, 15 Second, 1 minute, 3 minute, 10 minute and 30 minute.
Default setting for this item is Deactive.
 For canceling the lock mode, the power key should be pressed once, and the lock indicator
will be disappeared from the screen.
7-7
Brightness
To adjust Brightness, follow the instruction below:
 Press the Brightness option.
 The Brightness value is selectable from 5 to 99. Default setting for this item is 25.
 By scrolling, choose the proper brightness for the device.
7-8
Display Off
To turn off the display manually, follow the instruction below:
 Press the Display Off option so that the display turns off.
 To exit this mode, press the power button once.
 When the display goes off, if “Alarm LED” is activated, the LED lights at the top of the
front panel, will notify ongoing alarms. Furthermore, if the “Alarm Silence” is activated,
a blue flashing LED at the top of the front panel, will be enabled for 120 seconds showing
that the monitor is On.
Display Lock
When this option is selected, the touch screen of Pac T3 monitor will be locked and inactive
and the lock indicator will be shown in the upper-right corner of display page. To enable lock
option manually, follow the instruction below:
 Press the Display Lock option.
 The device will be on the lock mode.
 For canceling the lock mode, power key should be pressed once, and the lock indicator will
be disappeared from the screen.
Patient
In this section, patient information, including gender, age category and blood type can be set.
Furthermore, patient’s information can be erased. To adjust Patient, follow the instruction
below:
 Press the Setting option enter the password, press Ok and select Patient.
7-9
 Available options are Gender, Age Cat, Blood and Patient Discharge.
Gender
To adjust Gender, follow the instruction below:
 Press the Gender option.
 Available options are Male and Female (Default: Female).
7-10
Age Cat
To adjust Age Cat, follow the instruction below:
 Press the Age Cat option.
 Available options are Adult, Pediatric (Default) and Neonate.
Blood
To adjust Blood, follow the instruction below:
 Press the Blood option.
 Available options are A+, A-, B+, B-, AB+, AB-, O+, O- and Unknown. Default setting
for this item is UNKNOWN.
7-11
Patient Discharge
This option is to erase the patient’s information. To reach to the Patient Discharge option, follow
 Press the Patient Discharge option.
 By opening Patient Discharge window, the message “system will be completely erased,
Are You Sure?” will be shown. If selected YES, the settings will return to their default
values.
7-12
Setup
In this menu, time and date could be set and the Factory Reset is accessible here. By enabling
Factory Reset, all of the settings will change to their default value. To adjust Setup, follow
 Press the Setting option enter the password, press Ok and select Setup.
 Available options are Time, Date and Factory Setting.
Time
To set the time, follow the instruction below:
 Press the Time option.
 Select the proper hour and minute.
7-13
Date
To set the date, follow the instruction below:
 Press the Date option.
 Select the proper day, month and year.
7-14
Factory Reset
To reach to the Factory Reset option, follow the instruction below:
 Press the Factory Reset option.
 By opening Factory Reset window, the message “system will be completely erased, Are
You Sure?” will be shown. If selected YES, the settings will return to their default values.
About
In this section, some information regarding the device and the manufacturer. To observe the
About option, follow the instruction below:
 Press the Setting option enter the password, press Ok and select About.
 The following information will be displayed.
 Name of the product: Pac T3
 Name of manufacturer: TRIONARA CO
 Company Fax Number
 Support line
 Release Date
 Version of software
 Company email address
7-15
Param Trend
In Param Trend page, all the HR, SPO2, RR and TEMP values are saved every one minute and
can be observed. Further information is accessible in chapter 8.
7-16
Chapter 8 Archive
In this chapter, further information related to the Alarm Review section and Param Trend page are
accessible. By selecting Alarm Review, all the alarms related to HR, SPO2 and RR parameters,
and the date and the time of alarm occurrence will be shown. Furthermore, in Param Trend page
all the HR, SPO2, RR and TEMP values of the patient are saved every one minute and can be
observed.
Alarm Review
By selecting Alarm Review, all the alarms related to HR, SPO2 and RR parameters and the date
and the time of alarm occurrence will be shown. To observe Alarm Review, follow the instruction
below:
 Press the Alarm Review.
 By pressing <PRV and NEXT> alarms can be observed.
Figure 8-1: Alarm Review
8-1
Param Trend
The history of the recorded parameters for the admitted patient (HR, Spo2, RR) can be seen
through this menu. To observe the Trend page, follow the instruction below:
 Press the Setting option enter the password, press Ok and select Param Trend.
 All the HR, SPO2, RR and TEMP values are saved every one minute and can be observed
in Param Trend. Press <<1hour, <5min, 5min> and 1hour>> options for observing
parameters. All the data for the last two months are accessible.
 To leave this page, press back.
Figure 8-2: Param Trend
8-2
Chapter 9 Mobile Application
Introduction
Trionara wearable application is designed to communicate with the Trionara wearable patient
care monitor (Pac T3) and can connect to the monitor simultaneously via Wi-Fi connection and
display all of the parameters and signals. One of the advantages of the application is the
possibility of making 12 leads of ECG out of 4 leads sent from the monitor and the ability to
display Multi-lead ECG signals. The application is also capable of communicating with the
Trionara internet based server to archive the records, 10 seconds of signals, and to receive the
sophisticated interpretation of ECG analyzed by Glasgow software on the server side; also, the
resulted report will be sent to any predefined email automatically for further evaluation.
Setup and Initial settings
1- Hold down the hotspot icon for a few seconds, enter the mobile hotspot settings, and set the
Network Name and Password values to “Saadatap01” and “12345678”, respectively.
2- turn on the mobile’s hotspot.
3- Set the monitor to Smart Phone mode. If the hotspot is set correctly, you can see the name of
the Wearable monitor, “XXXXX-mysimplelink" , in the Hotspot settings section as Connected
Devices.
4- Download the installable version of the application from the reference introduced by the
manufacturer and install it on your mobile phone.
9-3
Figure 9-1 Indicator of connection between Mobile and Monitor
Connecting the Monitor to Application
1- Put the monitor in “Smart Phone” mode
2- Turn on your mobile hotspot.
Note:
- Make sure that no VPN is active on the mobile phone.

- Before using the hotspot, if you use the Wi-Fi module to access the Internet, be sure to
turn off the Wi-Fi module and turn Mobile Data on to use the SIM card Internet.
- Some of the phones have 2 Wi-Fi modules and it is possible to use 2 modules
simultaneously, one in the form of a hotspot and the other to connect to the Internet;
But in order to use the Trionara application, in any case, it is necessary to turn off the
Wi-Fi before using the hotspot.
- If you run the app before the hotspot is turned on, the mobile IP will not be registered
in the app and the connection will not be established. Therefore, be sure the hotspot is
turned on before running the App.
- When turning on the hotspot, the mobile phone uses the WiFi module to communicate
with other devices. In this case, if others know the Network Name and Password of the
phone, they can connect to the Internet through your phone and use it. Therefore, be
careful in maintaining the confidentiality of this information.
3- Launch the Wearable app and wait for the signals and parameters to be displayed. After
connecting, the monitor connection indicator will turn green and you will see the bed number
(BED No) set on the monitor at the top of the main page of the application (refer to the user
guide section for more information.).
9-4
4- By pressing the “Record and Send” button, you can record and send the data to the server and
receive the email containing the report at the defined email address. Also, immediately after
sending the signal and receiving the interpretation from the server, the report summary will be
displayed in the signal panel for 1-minute blinking, and you can also view the signals and reports
by referring to the Records menu.
Note:
- Report email will be sent by the server as soon as possible and it may take a few minutes
to receive it.
- Receiving the results of interpretation and reviewing the submitted records is subject
to communication with the Internet and the server.
9-5
Application User Manual
Main page introduction
Figure 9-2 Application’s main page
1- Menu: Use this key to enter the main Menu
2- Bed no & Status Message indicator: The bed number is received and displayed when
connected to the monitor. Messages indicating the successful start, completion and sending of
the record and etc., are also displayed here.
9-6
Status Messages
Message Definition
Start Record Start data recording for 10 seconds
Stop Record End of Data Recording
The percentage of recording progress
Recording x% proportional to the registration progress
bar
Data has been sent to the server
Send File OK
successfully
The number of files, waiting to be sent to
File Remain: --
the server
Waiting for result Waiting for the report to be received
Phone’s IP that is used with monitor to
IP: xx.xx.xx.xx
make connection
Downloading Pdf Downloading the PDF Report
PDF report is downloaded and ready to be
Download Pdf End
checked
3- Patient Information Panel: Patient information including national identity number (shown at the
top of the report), age and gender that must be entered correctly at the time of registration
(information in this section could be modified from the USER tab in the main menu).
Note: The Glasgow software uses information about the patient's age and gender, in order
to interpret the ECG signals accurately.
4- Record Progress Bar: Displays the progress of the recording process; the application will record
and send 10 seconds of ECG signals per each record.
5- Signal Panel: In this section, ECG, Plethysmograph (SPO2), and Respiration signals are
displayed in different arrangements. To view the available layouts, click anywhere on the Signal
panel.
9-7
- Swipe from bottom to top or vice versa in the Signal panel to view the available layouts.
This way you can see other ECG leads.
- Moreover, to view the ECG multi-lead view, swipe from right to left or vice versa in
the Signal panel. On this page, the 12 leads of ECG are displayed simultaneously in the
signal panel (Leads V1, V3, V4, V6 are computationally generated using the data of
other leads and displayed in light blue.).
Figure 9-3 ECG Multi-Lead view
6- Record & Send key: Pressing this key will start the recording process, and after that the data
will be sent to the server automatically.
Note:
- Before pressing the record key, make sure about the quality of the signals as well as
the connection to the Internet, via mobile data. If you do not have an internet access,
the data will be recorded, and the transmission will be postponed until the internet
connection is established.
9-8
- Before pressing the key, make sure that the signals are of good quality, and for this
purpose it is necessary for the patient to be in a relaxed and motionless state for 15
seconds before the start of the recording and during the recording (for 10 seconds).
- The application is capable of adjusting the gain of display signals automatically based
on the amplitude of the input signals.
7- Parameter Panel: The parameters sent by the monitor are displayed here with a fixed layout.
8- Server Connection Indicator: After recording the signals and in case of internet connection, this
symbol will turn green that means establishing a connection with the server and sending the data.
In this case, the message “Send File OK” is also displayed in the status messages area.
Note: In case of no internet connection, the number of records that are in the sending queue
will be displayed status messages area as “File Remain: --“.
Communicating with the Absence of data Lack of Internet access
server and sending data submission requests and requests to send data
Figure 9-4 Server Connection Indicator states
Note: After sending the data to the server and seeing the “Send File OK” message,
displaying the message “Waiting for result”, means that the report is being prepared and
you can soon see the results under the Records menu. The summary of the interpretation is
also displayed in the signal panel for 1-minute blinking.
9- Monitor Connection Indicator: This symbol turns green in case of establishing a stable
connection with monitor
9-9
Figure 9-5 The interpretation summary displayed in the signal panel for 1
minute after sending data to the server
Disconnected from Monitor Connected to Monitor
Figure 9-6 Monitor Connection Indicator states
10- Heart Rate Detection Symbol: Appears on the screen when receiving the HR parameter, which
is calculated via ECG signals or the SPO2 sensor.
11- Data & Time: The date and time that is automatically received from the mobile phone and is
also specified in each recorded data.
9-10
Main Menu introduction
Figure 9-7 Trionara application main menu
By pressing the menu key, you will enter the main menu of the application and you will have
access to the following options:
User Tab
Device ID which can be the name / nickname

Device Code of the mobile phone owner or preferably his /
her national identity number.
Personal ID Unique Patient Identifier (Patient National

identity Number)
Age Patient Age
Sex Patient Sex
Physician Email The email address in which the report will be

received
9-11
Figure 9-8 User Tab
Setting Tab
The necessary settings for this section are included in the software by default and there is no need
to make changes. If it is necessary to change, the new settings are applied by the authorized experts
of the manufacturer.
Records Tab
At the top of this page, all recorded data can be seen. A green checkmark next to each record means
that the record has been sent to the server and the report has been prepared.
keys function
1- SIGNAL VIEW: By clicking on each record and pressing this key, the signals related to that
record are displayed on a separate page.
2- INTERPRETATION: By selecting each record and pressing this key, the interpretations and
measured parameters related to that record can be seen (signals without a green tick are un-
interpreted due to not being sent to the server).
9-12
3-PDF VIEW: Touch to see the PDF report contains signals, measurements and interpretations.
4- RESEND: By selecting each record and pressing this key, the selected record will be sent to the
server once again. If there is no green checkmark next to the record or you do not receive an email
containing the report within 5 minutes after sending the signal (if connected to the Internet), it is
recommended to use the RESEND key to resend the record.
5- DELETE: Use this key to delete the selected record.
6-DELETE ALL: Use this key to delete the whole archive.
Figure 9-9 Archive of recorded Figure 9-10 Interpretation (Left figure) & signal view pages (Right figure)
signals
9-13
Chapter 10 Accessories
ECG Accessories
Part Name Part Code Picture

ECG Cable
ECG patient cable, 3 leads P33048
ECG patient cable, 6 leads P33049
Recommended ECG Electrode

Adults ECG Disposable Electrodes, FIAB Manufacturer REF: F9060
Pediatric ECG Disposable Electrodes, FIAB Manufacturer REF: F9060P
Arbo H124SG, COVIDIEN Manufacturer REF: 31.1245.21
SPO2 (MASIMO) Accessories
The following accessories are recommended:

Masimo Adult Reusable Sensor, Weight > 30 Kg, (LNCS DCI) 1863
Masimo Neonatal SPO2 Disposable Sensor, Weight <1 Kg, (LNCS 2330
NeoPt)
Masimo Neonatal SPO2 Disposable Sensor, Weight <3 Kg or >40 Kg, 2329
(LNCS Neo)
10-14
Masimo SpO2 Extension (Red LNC-10) 2056
Masimo SPO2 Reusable Y- Sensor, (Adult, Neonate), Weight > 1 Kg 2258

(LNCS)
Masimo USpO2 Cable, (LNCS) 3315
Battery

Battery, Ansmann Manufacturer - 1.2V 2500 mA 5035431
Charger
 Note: Other SpO2 accessories may not compatible with your device.
 Caution: Before using accessories, pay attention to its expiry date.
10-15
Chapter 11 Care and Cleaning
System Check
Before using the monitor,
 Check if there is any mechanical damage in the system and accessories.

 Check if all the accessories are firmly connected.
 Check all the functions of keys, touch and modules to make sure that the monitor is in
proper condition.
 Warning: If you find any damage on the monitor, stop using the monitor on patient, and
contact the biomedical engineer of the hospital or local After Sale Service.
 Warning: The overall check of the monitor, including the safety check, should be performed
only by qualified personnel. All checks which need the monitor to be opened and safety and
maintenance checks should be performed by After Sales Service.
 Warning: If user does not follow a satisfactory maintenance schedule, the monitor may
become invalid, and human health may be endangered.
 Note: It is recommended that the system is calibrated by manufacturer every year, but it has to
be calibrated once every 2 years. The medical center can request the system calibration
whenever the system accuracy is in doubt.
 Note: The system lifetime is 5 years.
 Note: Use only the substances approved by us and methods listed in this chapter to clean
or disinfect your equipment. Manufacturer makes no claims regarding the efficacy of the
listed chemicals or methods as a means for controlling infection. For the method to
control infection, consult your hospital’s Infection Control Officer or Epidemiologist.
Also observe any local policies that apply within your hospital.
11-1
Cleaning and disinfection
 Warning: Before cleaning the monitor or the sensors, make sure that the equipment is
switched off and disconnected from the power line.
 Warning: Sterilization may cause damage to the device and is therefore not
recommended for this patient monitor otherwise indicated in the instructions delivered
with accessories or your hospital’s servicing schedule.
 Warning: If you see any signs of damage or deterioration in the device and its
accessories, do not use it, and if necessary, contact the after-sales service company.
 Warning: Allow the monitoring system to dry completely before making connections.
And please make sure all connectors tightly connected to the system before using the
system.
Please pay special attention to the following items:
1. The Pac T3 monitor and its belongings shall be kept dust-free.

2. Do not use strong solvents such as acetone or ammonia.
3. Most cleaning agents must be diluted before use.
4. Don't use rough or sharp material or your fingernail to remove stubborn stains.
5. Do not let the cleaning agent enter into the chassis of the system.
6. Do not leave the cleaning agents on any part of the equipment.
 Warning: Do not use EtO gas to disinfect the monitor.
External surfaces
In-between patients and as required:
For cleaning: wipe gently using a moist cloth and warm soapy water or mild detergent and for
disinfection use the following recommended agents:
■ Alcohol 70%
■ Isopropyl alcohol
■ N-propanol
11-2
Display screen
In-between patients and as required use clean and soft cloth with screen cleaner or mild soapy
water and with Isopropyl alcohol may be used for cleaning and disinfection.
 Note: Take extra care when cleaning the screen of the monitor because it is more
sensitive to rough cleaning methods than the housing.
 Note: Don't spray a liquid directly on the screen.
Accessories
Please observe the following cautions for cleaning and disinfecting the accessories.
 Warning: To avoid damaging of the cable, probe, sensor or connector, do not immerse it in
any liquid.
 Warning: Disposable accessories shall not be sterilized or reused.
 Warning: To prevent environmental pollution, the disposal of single-use accessories shall be
done in accordance with the policies of the hospital.
 Warning: Manufacturer has no responsibility for the effectiveness of controlling infectious
disease using these chemical agents. Please contact infectious disease experts in your hospital
for details.
 Note: Daily check of the accessories intactness (no mechanical damage) and accessories
function is recommended.
ECG Cable
Use soft cloth moistened with mild soap liquid or cleaning agent containing 70% ethanol to clean
the ECG cable. To avoid extended damage to the equipment, disinfection is only recommended
when stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities
should be cleaned first.
 Warning: Do not immerse ECG cable completely in water, solvents, or cleaning solutions
since it is not waterproof.
11-3
 Caution: Do not submerge the ECG cable in any cleaning solution or do not attempt to
sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method.
 Caution: If there is any sign indicating that the ECG cable may be damaged or deteriorated,
replace it with a new one instead of continuing its application on the patient.
SPO2 Probe
To clean, disinfect and sterilize reusable SPO2 accessories, refer to the instructions delivered with
the accessories.
 Warning: Do not immerse sensor and patient cable completely in water, solvents, or cleaning
solutions because the sensor and patient cable are not waterproof.
The following table summarizes the methods of cleaning, disinfecting and sterilizing different
parts of the device:
Device parts Single-use Cleaning Disinfection Sterilization
In-between patients
In-between patients and
and as required wipe To avoid extended
as required use
gently using a moist
External surface of device - ■ Alcohol 70% damage to the
cloth and warm
■ Isopropyl alcohol equipment, sterilization
soapy water or mild
■ N-propanol is not recommended for
detergent. this monitor, related
products, accessories or
supplies unless
otherwise indicated in
the Instructions for Use
that accompany the
accessories and
In-between patients supplies or when
and as required: In-between patients and stipulated as necessary
Display screen - Clean and soft cloth as required use in the Hospital
with screen cleaner ■ Isopropyl alcohol Maintenance Schedule.
or mild soapy water
11-4
disposable
- - -
electrodes
To avoid extended
damage to the
equipment, sterilization
is not recommended for
Disinfection is only
Use soft cloth this monitor, related
ECG Accessory recommended when
moistened with mild products, accessories or
stipulated as necessary in
soap liquid or supplies unless
the Hospital
ECG cable cleaning agent otherwise indicated in
Maintenance Schedule.
containing 70% the Instructions for Use
Disinfection facilities
ethanol to clean the that accompany the
should be cleaned first.
ECG cable. accessories and
supplies or when
stipulated as necessary
in the Hospital
Maintenance Schedule
disposable
-- -- --
sensor
SpO2 Accessory According to the instructions delivered with the reusable SPO2
accessories
SPO2 Probe To clean, disinfect and sterilize reusable SPO2 accessories, refer to
the instructions delivered with the accessory.
11-5
Preventive Maintenance (PM)
To ensure that the device is kept in the best condition, it shall be kept clean and all points related
to the maintenance of the system shall be observed. There are no repairable parts in the system
and all repairs shall be done by the manufacturer.
Storage
The storage environment shall be clean and dry. If possible, use the original packaging of the
device.
 Note: If the monitor or equipment falls from a height and is damaged or in the vicinity of
a very high temperature and high humidity, contact the company's after-sales service at
the earliest opportunity to ensure the correct operation.
 Note: Thoroughly clean the system before and after the system is not used for a while.
Weekly check of the following items is recommended: Monthly check of the following items is recommended:
1. Device cleanness 1. Calibration label (Sending the device to the

manufacturer for calibration at the specified date).
2. Visual inspection of device (case, screen, keys
and indicators) in terms of mechanical damage 2. Visual inspection of device in terms of
3. Visual inspection of accessories in terms of mechanical damage
mechanical damage
3. Device cleanness
4. Function of accessories
4. Function of keys and indicators
5. Disposable accessories and accessories with
5. Visual inspection of accessories in terms of
limited time of use.
mechanical damage
The preventive maintenance (PM) checklist should be completed by responsible individuals of

healthcare center. It should be noted that PM checklist only is used to perform systematic
inspection of the equipment and will not guarantee their correct function.
11-6
Chapter 12 Troubleshooting
Repairing the internal parts of the monitor must be only done by trained and authorized
personnel of After Sale Service; otherwise manufacturer will not take any responsibility for any
possible hazard to the patient and the monitor.
Troubleshooting guide is intended to help users to solve minor problems caused by incorrect use
of the monitor or failure of accessories.
When you face any problem, please be sure that you have followed all procedure mentioned in
Correct Action column before you contact with After Sale Service.
Fault Symptoms Possible Cause Correct Action

 Press the power button
for 5 seconds and a little
more to turn the monitor
on.
 Make sure that the
batteries are inserted
correctly into battery
container according to the
signs.
 Make sure that current
batteries are charged and
The monitor does
check the change the
not turn on
batteries with two un-
used ones.
 Check if the device is
turned on while the
charger is connected. If
so, call the after sales
service to make them
aware that device is not
working on batteries.
 Check POWER AC path
 Call for service
 Make sure that the
The monitor is  Battery is discharged batteries are inserted
unable to run on  Fuse of the battery is faulty correctly into battery
battery  etc. container according to the
signs.
12-1
 Change the batteries with
two unused ones which
are approved by
manufacturer.
 Connect ECG cable
correctly
 Check leads and
 ECG cable is notconnected electrodes.
correctly  Short-circuit all the leads,
NO ECG
 Bad placement of leads and if the cable is perfect, no
waveform
electrodes error message will be
 etc. displayed.
 Don’t use old and faulty
electrodes
 Check electrodes and
leads
 Check applied gel on the
chest lead or change the
 Loose connection of
chest lead, if necessary.
Noisy ECG electrodes
 Make the other sources of
waveform  Wrong ECG filter
noises such as cell phones
 etc. and etc. far from the
device.
 Set filter mode correctly
 If "PACE ON" is activated
for patient without Pace
Spike on ECG  Turn “Paced detection”
marker, ECG noise will be
waveform OFF in ECG menu
received as PACE.
 etc.
 Check leads and
electrodes.
 Select the patient age
 ECG signal is noisy or isn’t category (Adult,
Unstable HR suitable Paediatric and Neonate)
 etc. according to patient age.
 Change lead to display
the best ECG signal
No “RESP” signal  Check leads and
 Electrodes are not
No good waveform electrodes.
connected correctly
Unstable RR  Change RESP lead
12-2
 Patient moves during  Calm patient
measurement  Call for service
 etc.
 Change the place of
probe on patient
 Unplug and plug the
SPO2 socket
No SPO2  SPO2 probe in an  Change the probe and
waveform unsuitable place. check the waveform.
noisy  Faulty sensor Contact the
SPO2waveform  etc. manufacturer to
replace the probe with
a new one, if
necessary.
 Calm patient
 Change the place of
probe
 Patient movement during  Pay attention to
measurement technical alarms
Invalid SPO2 value  Probe is placed in an which are related to
unsuitable position. SPO2; Such as, Low
 etc. perfusion and etc. to
do the correct
modification.
 Check if the alarm
indicators are working
once during the
device initialization, it
Alarm Indicators demonstrates the
are not working accuracy of
indicators. Alarms
settings should be
changed to On mode.
 Check the Access
Point setting (SSID,
Password)
No connection
 Check the bed number
between device and
and make sure it is
central system.
not conflicting with
another device.
12-3
 Batteries should be
charged or replaced
 The inserted batteries are
with full charged
not suitable for the device
ones.
Device resets and they are not approved
 Reduce the display
repeatedly by manufacturer.
brightness and turn
 The batteries are going to
the WIFI off, if it is
be depleted
not required.
Some advices to reduce measurement errors:
 If patient is walking or moving, connect the device to the patient's body by means of
designed belt in order to prevent from device's excessive movements.
 In lying position, put the device in a proper distance beside the patient's bed, in order to
prevent the patient from falling on device.
 When the device is connected to AC supply to charge the batteries, it is more probable to
get noisy signals.
12-4
Chapter 13 Technical Specifications
CLASSIFICATION
INTERNALLY POWERED MEE, Type CF for
Protection against electroshock
all modules (based on IEC 60601-1).
Mode of operation Continues operation equipment
Harmful Liquid Proof Degree IP32
DISPLAY
Pac T3 TFT COLOR 480 × 320, 3.5”
Waveforms ECG, SPO2, RESP
Numeric Parameters HR, SPO2, PR, RR, Alarm Limits
Operation Method Membrane/Keys, Touch Screen
ECG
Selectable 3 or 6 Wires
Lead and wire options For 3 wire: I, II, III
For 6 wire :I, II, III, V2, V5, aVR, aVF, aVL
Dynamic Range +-5mv
Lead Off Current 70 nA
Gain 2, 1, 1/2, 1/4, 1/8, Auto
Calibration 1mV, 0.5 sec
“MONITOR” (0.5 - 24 Hz)
Filters “NORMAL” (0.5 - 40 Hz)
“EXTENDED” (0.05-100 Hz)
CMRR 110 dB
Internal Noise < 22 uV
Input Impedance 0.94 GΩ @ 10 Hz
Duration: 40 to 120 msec

QRS Detection Amplitude: 0.25 to 5 mV for Adult/Pediatric
0.2 to 5 mV for Neonate
15 - 300 BPM for adult/pediatric
Heart Rate Range
15 - 350 BPM for neonate
Accuracy ±1% or 2 BPM
Tall T-Wave Reject up to 1.2 mV Amp
Pacer Detection/Rejection Duration : 0.1 - 2 msec
13-1
Amp: ±2 to ± 700 mV (Without over/undershoot)
Reject from heart rate counter
Re-insert into ECG to display on screen
Ineffective pace rejection:
HR:0, Pace: 60
HR:60, Pace:60
HR:30, Pace:80
Beside rejection of atrial paces precede
ventricular paces by 150 or 250 ms
Protection Defibrillator and Electro surgery
Standards ANSI/AAMI EC-13, EN 60601-2-27
SPO2 (Masimo Set)

Method 2 Wave length pulse wave type
SpO2 0 – 100 %
Range PR 25 – 240 bpm
PI 0 – 20.0 %
Oxygen Saturation
No motion conditions: Adult/Pediatric: ±2% (SPO2

70 ~ 100%), Neonate: ±3% (SPO2 70 ~ 100%)
During motion conditions: Adult/Pediatric/Neonate:

±3% (SPO2 70 ~ 100%)
During low perfusion conditions:

Adult/Pediatric/Neonate: ±2% (SPO2 70 ~ 100%)
Accuracy
Pulse Rate
During no motion conditions:

Adult/Pediatric/Neonate: ±3bpm (PR 25 ~ 240)
During motion conditions: Adult/Pediatric/Neonate:

±5bpm (PR 25 ~ 240)
During low perfusion conditions:
Adult/Pediatric/Neonate: ±5bpm (PR 25 ~ 240)
SpO2 1%
Resolution PI 0.1 %
PR 1 BPM
RESPIRATION
Method Impedance
13-2
Base Resistance 250 -1250 Ohm
Dynamic Range 0.2 - 2 Ohm
Breath Rate Range 0 - 253 BrPM
Accuracy ±2% or 2 BrPM
ALARM
Sources Error messages, All other parameter limits
Alarm On/Off Selectable for all parameters
Blinking on Display, Volume Selectable Audio
Alert
Alarms, Light indicator
TREND
Sources HR, SPO2, RR ()
Trend Time Save 96 Hours
Trend Time Interval 1 sec
INPUT/OUTPUT PROTOCOL
Reliable TCP/IP Protocol over WIFI standard
Network
802.11 b/g/n @ 2.4 GHz
GENERAL
Safety Based on IEC 60601-1, Class I
Protection Against Electro surgery and Defibrillator
Rechargeable: 1.2 V, 2400 mAh
Internal Battery Charge Time: Around 3 Hours
Usage: More than 18 Hours
Physical Specification
With Battery: 218 gr
Weight (approximately)
Without Battery: 152 g
Dimension (Cm) 135(W) × 65(H) × 30(D)
ENVIROMENTAL
Operating: 5 to 40 ◦C (41 ~ 104 ◦F)
Temperature
Storage & Transport: -25 to 60 ◦C (-13 ~ 140 ◦F)
Operating: 20-90 % (Noncondensing)
Humidity
Storage & Transport: 10-100 % (Noncondensing)
Altitude -200 to 3000 m
13-3
Chapter 14 Messages and Alarms
Physiological Alarms
Alarm Situation Visual Alarm Audio Alarm

ECG Alarms
 HR is "0" and blinks.
Heart beat is not  Alarm indicator flashes.
ECG Asystole detected in last 10  Message "ECG Activated
ASYSTOLE" is
seconds. displayed in red
background.
 HR value blinks.
 Alarm indicator flashes.
Heart rate violates  Alarm message is
HR High displayed in a Activated
adjusted high limit.
background
corresponding to its
level.
 HR value blinks.
Heart rate violates  Alarm message is
HR Low displayed in a Activated
adjusted low limit.
background
level.
Respiration Alarms
Non-respiration  Alarm indicator flashes
Apnea condition overruns  "RESP APNEA" is Activated
displayed in red
adjusted time. background.
 RESP value blinks
Respiration rate  Alarm indicator flashes.
 Alarm message is
RR High violates adjusted high displayed in a Activated
limit. background
level.
14-1
 RESP value blinks
Respiration rate  Alarm indicator flashes.
 Alarm message is
RR Low violates adjusted low displayed in a Activated
limit. background
level.
SPO2 Alarms
 SPO2 value blinks.
SPO2 violates  Alarm message is
%SPO2 HIGH displayed in a Activated
adjusted high limit
background
level.
 SPO2 value blinks.
SPO2 violates  Alarm message is
%SPO2 LOW displayed in a Activated
adjusted low limit
background
level.
 PR value blinks.
PR value violates  Alarm message is
PR High displayed in a Activated
adjusted high limit.
background
level.
 PR value blinks.
PR value violates  Alarm message is
PR Low displayed in a Activated
adjusted low limit.
background
level.
14-2
Technical Alarms
Alarm Cause Solution Explanation

System Alarms
Alarm level 3- the message
is displayed in cyan
Change the batteries
Battery charge is background. By pressing
LOW BATTERY with full charge
less than %25. ALARM SILENCE, alarm
batteries.
is disabled and ignores this
fault.
ECG Alarms
background. By pressing
ECG NO CABLE ECG cable is not
connected to the Connect ECG cable. ALARM SILENCE, alarm
system. is disabled and ignores this
fault until reconnecting the
cable.
Check for any possible
sources of signal noise
in the area around the
ECG signal is background. By pressing
ECG_NOISE cable and electrode, and
noisy or saturated. ALARM SILENCE, alarm
check the patient for
great motion and also
fault.
check the lead wires.
Power off and then on Alarm level 2- the message
the system .If this is displayed in yellow
ECG module message is displayed background. By pressing
ECG DEFECT
failure again the user should ALARM SILENCE, alarm
contact local After Sale is disabled and ignores this
Service. fault.
14-3
Mentioned lead is Make sure that is displayed in yellow
not properly mentioned electrode is background. By pressing
ECG CHECK LL
connected to the properly connected to ALARM SILENCE, alarm
patient. the patient. is disabled and ignores this
fault.
ECG CHECK LA
fault.
ECG CHECK RA
fault.
Mentioned lead is Make sure that all is displayed in yellow
not properly electrodes esp. C and background. By pressing
ECG CHECK C
connected to the ECG cable are properly ALARM SILENCE, alarm
patient. connected to the patient. is disabled and ignores this
fault.
RL or other leads Alarm level 2- the message
are not properly Make sure that all is displayed in yellow
ECG CHECK RL connected to the electrodes esp. RL and background. By pressing
OR ALL patient when ECG ECG cable are properly ALARM SILENCE, alarm
lead is V, aVR, connected. is disabled and ignores this
aVF or aVL. fault.
14-4
The ECG leads are Make sure that all is displayed in yellow
ECG CHECK not properly electrodes, lead are background. By pressing
LEAD
fault.
Respiration Alarms
The RESP leads Make sure that all
RESP CHECK are not properly electrodes, lead are
ALARM SILENCE, alarm
LEADS connected to the properly connected to
patient. the patient.
fault .Alarm is activated
when RR ALARM is "ON".
SPO2 Alarms
SPO2 external Make sure that the is displayed in cyan
SPO2 NO module is not external module is background. By pressing
MODULE connected to the firmly connected to the ALARM SILENCE, alarm
device. device. is disabled and ignores this
fault.
SPO2 sensor is Make sure that the
SPO2 NO SENSOR disconnected from sensor is firmly
the cable. connected to the cable.
fault.
Alarm level 2- The message
SPO2 sensor may Make sure that SPO2
SPO2 SENSOR is displayed in yellow
be detached from sensor is properly
OFF background. By pressing
the patient. attached to the patient
14-5
fault.
Make sure that the SpO2 is displayed in cyan
SPO2 cable is not
cable is correctly background. By pressing
SPO2 NO CABLE fully inserted to
connected into the ALARM SILENCE, alarm
the module.
module. is disabled and ignores this
fault.
The SPO2 sensor is displayed in yellow
SPO2 REPLACE is damaged or the Change the SPO2 background. By pressing
SENSOR proper sensor is sensor. ALARM SILENCE, alarm
not used is disabled and ignores this
fault.
is displayed in yellow
Incompatible
SPO2 INCOMP Change the SPO2 background. By pressing
SpO2 sensor is
SENSOR sensor. ALARM SILENCE, alarm
used
fault.
SPO2 SENSOR The patient sensor Replace the SPO2 background. By pressing
EXPIRED life has expired. sensor. ALARM SILENCE, alarm
fault.
SPO2 sensor is Make sure that the Alarm level 2- The message
SPO2 CHECK damaged or sensor is firmly is displayed in yellow
SENSOR disconnected from connected to the cable/ background. By pressing
the cable. Replace the sensor ALARM SILENCE, alarm
14-6
fault.
When a single-
patient use sensor Make sure that the
is used, the adhesive portion is
SPO2 NO TAPE ALARM SILENCE,
adhesive portion of firmly connected to the
background becomes gray
the sensor is not sensor.
and alarm is disabled and
connected.
ignores this fault.
The adhesive
SPO2 TAPE Replace the adhesive background. By pressing
patient sensor life
EXPIRED SPO2 sensor. ALARM SILENCE, alarm
has expired.
fault.
Incompatible
SPO2 INCOMP Change the SPO2 background. By pressing
SpO2 adhesive
TAPE adhesive sensor. ALARM SILENCE, alarm
sensor is used
fault.
The adhesive
SPO2 sensor is
SPO2 REPLACE Change the adhesive background. By pressing
damaged or the
TAPE SPO2 sensor. ALARM SILENCE, alarm
proper sensor is
not used
fault.
The SPO2 signal Alarm level 2- The message
SPO2 LOW amplitude is too Change the sensor is displayed in yellow
PERFUSION weak or position. background. By Pressing
undetectable. ALARM SILENCE, alarm
14-7
fault.
is displayed by yellow
This may be
caused by entering Make sure that SPO2
SPO2 AMBIENT ALARM SILENCE, alarm
environmental sensor is properly
LIGHT is suspended for at least
light into the connected to the patient.
120s. Alarm is activated
sensor.
when SPO2 ALARM is
"ON".
High intensity
light such as Alarm level 2- The message
pulsating strobe is displayed by yellow
lights, excessive background. By pressing
Place a Masimo Optical
SPO2 ambient light ALARM SILENCE, alarm
Light Shield over the
INTERFERENCE sources such as is suspended for at least
sensor.
surgical lights or 120s. Alarm is activated
direct sunlight, or when SPO2 ALARM is
other monitor "ON".
displays.
SPO2 CABLE The patient cable background. By pressing
Replace the SPO2 cable.
EXPIRED life has expired. ALARM SILENCE, alarm
fault.
The SPO2 cable is Alarm level 2- The message
SPO2 REPLACE damaged or the is displayed in yellow
Change the SPO2 cable.
CABLE proper cable is not background. By pressing
used ALARM SILENCE, alarm
14-8
fault.
SPO2 INCOMP Incompatible background. By pressing
Change the SPO2 cable.
CABLE SpO2 cable is used ALARM SILENCE, alarm
fault.
cable or/and sensor
SPO2 CHECK background. By pressing
is not working Check cable and sensor
PROBE ALARM SILENCE, alarm
properly.
fault.
Power off and then on
the system. If this
SPO2 BOARD background. By pressing
SPO2 board failure message is displayed
FAILURE ALARM SILENCE, alarm
again, Change the
uSPO2 cable.
fault.
14-9
Messages
Message Cause Solution Explanation

SPO2 Messages
If instrument fails to
display within 30
seconds, disconnect
In this condition
SPO2 PULSE Instrument is and reconnect. If
SPO2 value is
SEARCH searching for pulse. pulse search
displayed blank.
continues, move
sensor to better
perfused site.
Provide a new sensor In this condition
SPO2 SENSOR The patient sensor
to replace it if SPO2 value is
NEAR EXP life is near expired.
necessary. displayed.
The patient adhesive Provide a new sensor In this condition
SPO2 TAPE NEAR
sensor life is near to replace it if SPO2 value is
EXP
expired. necessary. displayed.
Provide a new cable In this condition
SPO2 CABLE The patient cable life
to replace it if SPO2 value is
NEAR EXP is near expired.
necessary. displayed.
Ensure proper sensor
In this condition
SPO2 LOW application. Move
Low signal quality. SPO2 value is
SIGNAL IQ sensor to a better
displayed.
perfused site.
A Demonstration tool
SPO2 DEMO Replace with a
is currently connected patient cable and -
MODE sensor (if necessary)
to the sensor
14-10
Occurs during an See the accessory
unsuccessful sensor directions for use. In this condition
SPO2 ONLY Use a Masimo light
initialization/pulse SPO2 value is
MODE shield to cover the
search routine or sensor and adjust the displayed.
during monitoring. sensor.
If values are not

displayed within 30
seconds,
Device is checking In this condition
SPO2 SENSOR disconnect and
the sensor for proper reconnect sensor. If SPO2 value is not
INIT
functioning values are displayed.
still not displayed,
replace with a new
sensor.
14-11
Appendix I EMC
 Warning: Use only the recommended manufacturer accessory. Using the accessory other than
in relevant chapter may cause to increase the EMISSION or decrease the IMMUNITY of
system.
 Warning: Measurements can be affected by mobile and RF communications equipment. It
should be assured that the wearable patient care monitor is used in the electromagnetic
environment specified.
 Warning: To prevent EMC effect on the monitor, the system should not be used adjacent to
or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment
should be observed to verify correct performance in the configuration in which it will be used.
 Warning: Do not use cellular phone in the vicinity of this equipment. High level of
electromagnetic radiation emitted from such devices may result in strong interference with the
monitor performance.
EMC Declaration for Pac T3
Guidance and manufacturer's declaration – Pac T3 emissions
The Pac T3 is intended for use in the electromagnetic environment specified below. The customer or
the user of the Pac T3, should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
The Pac T3 must emit electromagnetic

RF emissions energy in order to perform its intended
Group 2
CISPR 11 function. Nearby electronic equipment may
be affected.
RF emissions
Class B
CISPR 11
Harmonic emissions
N.A The Pac T3 is suitable for use in all
IEC 61000-3-2
establishments.
Voltage fluctuations/ flicker
emissions N.A
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
the user of the Pac T3 should assure that it is used in such an environment.
Electromagnetic
Immunity test Port Compliance level
environment - guidance
±8 kV contact
Enclosure ±2 kV, ± 4kV, ± 8kV,
± 15 kV air Floors should be wood,
concrete or ceramic tile. If
Electrostatic discharge floors are covered with
(ESD) IEC 61000-4-2 Patient coupling N.A synthetic material, the
relative humidity should
be at least 30%.
Signal input/output
N.A
parts
Electrical fast Input a.c. power N.A

transient/burst Signal input/output
IEC 61000-4-4 N.A
parts
Input a.c. power N.A
Surge
Signal input/output
IEC 61000-4-5 N.A
parts
Voltage dips, N.A
Input a.c. power
IEC 61000-4-11 N.A
Voltage interruptions
Input a.c. power N.A
IEC 61000-4-11
Power frequency magnetic
Power frequency fields should be at levels
(50/60 Hz) magnetic 30 A/m characteristic of a typical
Enclosure
field 50 Hz or 60 Hz location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of test level.

Guidance and manufacturer's declaration – electromagnetic immunity
the user of the Pac T3 should assures that it is used in such an environment.
Electromagnetic
Immunity test Port Compliance level environment –
guidance
Input a.c. power
Conducted RF N.A
PATIENT coupling
IEC 61000-4-6
Signal input/output
parts
Radiated RF 3 V/m, 80 MHz - 2,7 GHz,

ENCLOSURE
IEC 61000-4-3 80% AM at 1 kHz
Proximity fields from RF

wireless Refer to the following table
communications ENCLOSURE (table 9 of EN 60601-1-2:
equipment 2015)
IEC 61000-4-3
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment
IMMUNITY
Test Maximum
Band a) a) b) Distance TEST
frequency Service Modulation power
(MHz) (m) LEVEL
(MHz) (W)
(V/m)
Pulse
385 380- 390 TETRA 400 modulation b) 1.8 0.3 27
18 Hz
FM C)
GMRS 460, ±5 KHz
450 430- 470 2 0.3 28
FRS 460 deviation
1 KHz sine
710 Pulse
LTE Band 13,
745 704- 787 modulation b) 0.2 0.3 9
17
780 217 Hz
810 GSM 800/900,
TETRA 800, Pulse
870 800- 960 iDEN 820, modulation b) 2 0.3 28
CDMA 850, 18 Hz
930 LTE Band 5
1720 GSM 1800;

CDMA 1900;
Pulse
GSM 1900;
1845 1700- 1990 modulation b) 2 0.3 28
DECT; LTE
217 Hz
Band 1, 3, 4 25;
1970 UMTS
Bluetooth,
WLAN, 802.11 Pulse
2450 2400- 2570 b/g/n, RFID modulation b) 2 0.3 28
2450, LTE 217 Hz
Band 7
5240 Pulse
WLAN 802.11
5500 5100- 5800 modulation b) 0.2 0.3 9
a/n
5785 217 Hz
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.

Trionara 06 UM Pac T3 E211128

Uploaded by

Copyright:

Available Formats

Trionara 06 UM Pac T3 E211128

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Trionara 06 UM Pac T3 E211128

Uploaded by

Copyright:

Available Formats

Trionara Technologies AB.

18766. Täby. Sweden.

Web site: www.trionara.com

Release date Version number

November 2021 TD000330-06

Read this manual carefully before patient use of the monitor.

Intended Use of Product ........................................................................................................... 1-1

Symbols used in Pac T3 Monitor ............................................................................................. 1-3

Installation and Setup ............................................................................................................... 1-4

General Warnings ..................................................................................................................... 1-4

Environmental conditions ........................................................................................................ 1-6

Chapter 2 System Configuration .............................................................................................. 2-1

Introduction .............................................................................................................................. 2-1

Getting Started.......................................................................................................................... 2-3

Turn On ................................................................................................................................ 2-3

Turn Off ................................................................................................................................ 2-3

Lock Mode ............................................................................................................................... 2-4

Front Panel Functional keys ..................................................................................................... 2-5

Main Page................................................................................................................................. 2-7

Connecting the Accessories ..................................................................................................... 2-8

Battery Operation ..................................................................................................................... 2-8

Battery Status ........................................................................................................................... 2-9

Charger ..................................................................................................................................... 2-9

Connecting to Wi-Fi Status ................................................................................................ 2-10

Chapter 3 Alarms ....................................................................................................................... 3-1

Introduction .............................................................................................................................. 3-1

Manifestation of Patient Alarms........................................................................................... 3-1

Technical alarms ...................................................................................................................... 3-2

Manifestation of Equipment Alarms .................................................................................... 3-2

Messages .................................................................................................................................. 3-2

Manifestation of Messages ................................................................................................... 3-2

Alarm Level and Setup ............................................................................................................. 3-3

Alarm Modes ........................................................................................................................ 3-3

Display Screen ...................................................................................................................... 3-3

Alarm Indicator ........................................................................................................................ 3-3

Audio Alarm ......................................................................................................................... 3-4

Alarm verification ................................................................................................................ 3-4

Alarm Silence Button Function ................................................................................................ 3-4

Chapter 4 ECG ........................................................................................................................... 4-1

Introduction .............................................................................................................................. 4-1

Preparations .............................................................................................................................. 4-3

Skin Preparation ................................................................................................................... 4-4

ECG 3-lead electrode placement .......................................................................................... 4-5

ECG 6-lead electrode placement .......................................................................................... 4-6

Normal QRS waveform ........................................................................................................ 4-7

ECG Appearance ...................................................................................................................... 4-7

Freeze ................................................................................................................................... 4-8

ECG MENU ............................................................................................................................. 4-8

ECG Lead ........................................................................................................................... 4-10

HR Source .......................................................................................................................... 4-12

HR Alarm ........................................................................................................................... 4-13

HR Alarm Level ................................................................................................................. 4-14

HR Alarm Limit ................................................................................................................. 4-14

ECG Filter .......................................................................................................................... 4-15

Pace Detect ......................................................................................................................... 4-16

Sweep ................................................................................................................................. 4-17

Chapter 5 Respiration ............................................................................................................... 5-1

Respiration Monitoring ............................................................................................................ 5-1

Electrode Placement for Respiration .................................................................................... 5-1

Checklist for RESP Monitoring ........................................................................................... 5-1