Defibrillator

TEC-5601/TEC-5602
TEC-5611/TEC-5621
TEC-5631
TEC-5600 series
 Functions
Defibrillator
Manual mode: For charging to a user-specified energy level by using the
CHARGE/AED
button
Manual sync mode: For charging to a user-specified energy level by using the
CHARGE/AED
button, then discharging in synchronization with the R-wave of an ECG
after the SHOCK button is pressed
AED mode: For charging up to the automatically specified energy level when
defibrillation is required for the ECG. The energy level varies, depending
on the sequence defined in advance
AED mode (child mode): For charging up to the automatically specified energy
level for a child
when defibrillation is required for the ECG. The energy level varies,
depending on the sequence defined in advance. This mode is for preschool
children only
Output energy (with loading of 50 Ω)
External paddles: 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, or 270 J selectable
Internal paddles: 2, 3, 5, 7, 10, 15, 20, 30, or 50 J selectable
Disposal pads: 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, or 270 J selectable
AED mode: 1st: 150 J, 2nd: 200 J, 3rd: 200 J (default settings)
(The settings can be selected from among 50, 70, 100, 150, 200, and 270 J.)
AED mode (child mode):
1st: 50 J, 2nd: 70 J, 3rd: 70 J (default settings)
(The settings can be selected from among 50, 70, and 100 J.)
VF/VT analysis: Analysis is performed in the background or when the AED button is
pressed (depending on the setting). In AED mode, the requirement for
defibrillation is determined for ventricular fibrillation waveform of
amplitude more than 0.1 mV and a ventricular tachycardia more than
180 bpm.
Internal discharge: For discharging the charged energy to the internal
resistance in the
following cases:
• When power is turned off
• When the control dial is set to DISARM, AED, MONITOR, BASIC
CHECK, PACING, or SETUP
• When 40 seconds or more have elapsed from when a charge completed,
depending on the setting of “Charge Holding Time” (default setting:
40 seconds) in the system setup
• When a paddle is disconnected from the defibrillator
• When a disposal pad is disconnected from the patient
• When discharging with the released external or internal paddles
• When detecting an ECG that requires no defibrillation in AED mode
TTR detection: For measuring the transthoracic electric resistance of a patient
Discharged energy detection:
For measuring the discharged energy

Transcutaneous Pacing 1
Demand mode: For delivering pacing pulses at the specified pacing output current
when
there is no spontaneous QRS within the time calculated from the specified
pacing rate
Fixed mode: For delivering pacing pulses at the specified pacing rate and output
current for a patient having no spontaneous QRS

Note the following information when servicing the defibrillator.

Safety

• There is the possibility that the outside surface of the defibrillator, such as the
operation keys, could be
contaminated by contagious germs, so disinfect and clean the defibrillator before
servicing it.
When servicing the defibrillator, wear rubber gloves to protect yourself from
infection.
• There is the possibility that when the lithium battery is broken, a solvent inside the
lithium battery could
flow out or a toxic substance inside it could come out. If the solvent or toxic
substance touches your
skin or gets into your eye or mouth, immediately wash it with a lot of water and see a
physician.
Liquid ingress
• The defibrillator is not waterproof, so do not install the defibrillator where water or
liquid can get into
or fall on the defibrillator. If liquid accidentally gets into the defibrillator or the
defibrillator accidentally
drops into liquid, disassemble the defibrillator, clean it with clean water and dry it
completely.
After reassembling, verify that there is nothing wrong with the patient safety checks
and function/
performance checks. If there is something wrong with the defibrillator, contact your
Nihon Kohden
representative to repair.
Environmental safeguards
• Depending on the local laws in your community, it may be illegal to dispose of the
lithium battery in the
regular waste collection. Check with your local officials for proper disposal
procedures.
Disinfection and cleaning
• To disinfect the outside surface of the defibrillator, wipe it with a non-abrasive cloth
moistened with
neutral detergent.
Transport
• Use the specified shipment container and packing material to transport the
defibrillator. If necessary,
double pack the defibrillator. Also, put the defibrillator into the shipment container
after packing so that
the buffer material does not get into the inside of the defibrillator.
• When transporting a board or unit of the defibrillator, be sure to use a conductive
bag. Never use
an aluminum bag when transporting a board or unit which a lithium battery is
mounted. Also, never
use a styrene foam or plastic bag which generates static electricity to wrap the board
or unit of the
defibrillator.
Handling the defibrillator
• Because the outside surface of the defibrillator is made of resin, the outside surface
of the defibrillator
is easily damaged. So when handling the defibrillator, remove clutter from around the
system and be
careful to not damage the defibrillator or get it dirty.
• Because most of the boards in the defibrillator are multilayer boards with surface
mounted electrical
devices (SMD), when removing and soldering the electrical devices, a special tool is
required. To avoid
damaging other electrical components, do not remove and solder SMD components
yourself.
Measuring and test equipment
• Maintain the accuracy of the measuring and test equipment by checking and
calibrating it according to
the check and calibration procedures.
Preventing infection
• Follow the local laws or regulations to prevent infection.

Patient Safety Checks

Periodic maintenance procedures and diagnostic check procedures are provided
in this manual to ensure that the defibrillator is operating in accordance with its
design and production specifications. To verify that the defibrillator is working
in a safe manner with regard to patient safety, patient safety checks should
be performed on the defibrillator before it is first installed, periodically after
installation, and after any repair is made on the defibrillator.
For patient safety checks, perform the following checks as described in the
IEC60601-1 “Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance”:
• Protective earth resistance check
• Earth leakage current check

Touch current check

• Patient auxiliary current check
• Withstanding voltage check
NOTE: When using a delivery checker to input ECG to the defibrillator,
the ECG polarity depends on the delivery checker model and
connection of the pads/paddles. For details on a delivery checker,
refer to the manual of the delivery checker.

Monitor
Electrocardiogram (ECG)
Induction
Disposal pads: Pads
External or internal paddles:
Paddles
3 leads: I, II, III
6 leads: I, II, III, aVR, aVL, aVF, Va, Vb
External ECG input: AUX
Filter: “DIAGNOSIS”, “MONITOR”, or “MAXIMUM” selectable for ECG
Pacemaker pulse rejection:
Equipped with a function activated to prevent output waveforms of the
pacemaker installed in a patient from being detected as QRS
Hum filter: “ON” or “OFF” selectable for the hum noise (50 or 60 Hz)
ESU filter: Equipped with a filter for rejecting noise incorporated into the ECG when
an ESU is used
Electrode disconnection detection:
Equipped with a function to detect disconnection of an electrode
Abnormal polarization detection:
Equipped with a function to detect possible distortion of an ECG caused
by polarizing voltage
Arrhythmia analysis: When arrhythmia analysis is “ON” in monitor mode (with the
limb/
chest lead selected), the analysis is performed. Depending on the setting
for QRS detection type, the method of arrhythmia analysis is switched
between “CHILD” and “ADULT”.
SpO2
Pulse rate, pulse wave, and SpO2 value can be measured by connecting a
probe to the SpO2 socket.
CO2
ETCO2 value, CO2 waveform, and respiration rate can be measured by
connecting a CO2 sensor kit to the CO2 socket.

Character, Symbol, and Graphic Symbol Indications

Battery remaining: Indicates the battery remaining.
Recorder operation: Indicates operation statuses of the recorder.
SD card operation: Indicates operation statuses of an SD card.
Bluetooth® indication: Indicates connection statuses of a Bluetooth® module.
Defibrillation mode: Indicates manual mode, synchronized cardioversion mode,
AED mode, or
AED mode (child mode) for defibrillation.
Pacing mode: Indicates the selected mode, fixed or demand, with “PACING”.
Analysis/charging/charging complete messages:
Indicate “ANALYZING” in VF analysis, “CHARGING” in energy
charging, or “CHARGING COMPLETE” when charging is complete.
Number of discharges: Indicates the number of discharges after power-on.
Voice message indication: Displays the same messages as the voice messages in
AED mode.
Vital alarm: Displays an alarm message if any measured value of a parameter
exceeds
the upper or lower limit of an alarm or if an arrhythmia is detected.
Technical alarm: If an error for the defibrillator or for measurement environment is
detected, an alarm message is displayed.

Display language: Language selection is enabled by a setting. Installing the

software 1
program enables you to select the language.

Status Indicator
After a self test, the indicator shows “○” in green if the test ends normally.
During a self test or if any problem occurs in the defibrillator, the
indicator shows “×” in red.
Alarm Indicator
The indicator lights or blinks in cyan, yellow or red if vital information
exceeds the upper or lower limit of an alarm, or depending on the
measurement environment and defibrillator status such as a battery status.
LED Indications
AC power lamp: Lights when the power cord is connected and an AC power is
supplied to
the defibrillator.
Battery charging lamp: Lights when the power cord is connected and the installed
battery is in
charging. If the battery temperature is not suitable for charging, the lamp
blinks.
Battery charging completion lamp:
Lights when the power cord is connected and charging to the installed
battery is completed.
PACING PULSE lamp: Lights in synchronization with pacing pulse outputs.
SHOCK button lamp: The SHOCK button flashes when energy charging is
completed and
discharging is enabled.
Shock button lamps: The shock buttons on external paddles flash when energy
charging is
completed and discharging is enabled.
Paddle contact lamp: Lights in green, yellow or orange, depending on the
resistance (in
3 stages) between the external paddles.
Frozen Waveform Display
Pressing the [FREEZE] key in monitor mode freezes the displayed
waveform for 3 minutes.

For Defibrillation
Sound during charging: Continuous sound is heard during charging.
Sound at charge completion:
Continuous sound is heard when charging is complete.
Operation sounds: In manual mode, the function can be turned on/off by a user
setting. In
AED mode, continuous sound is heard except when analyzing an ECG.
For Alarms
Technical alarm sound: An alarm sound is generated when an error occurs in the
defibrillator or in
the measurement environment.
Vital alarm sound: An alarm sound is generated when vital information on any
parameter
exceeds the upper/lower limits of the allowable range.
Alarm sound priority: Alarm sounds have priority and vary in tone in accordance with
the
priority.
Voice
AED mode: Voice instructions are made for the sequence in AED mode.
AED mode (child mode): Voice output is made to announce child mode. Voice
instructions for the
sequence are the same as those in AED mode.
Microphone input: Ambient sounds are captured by the microphone and stored with
ECG,
SpO2, and CO2 on an SD card
Sound Volume Adjustment
Volumes of synchronization sounds, charging sounds, operation sounds,
alarm sounds, and voice instructions can be adjusted to the values in
accordance with the user settings in setup mode

Self Tests
The defibrillator automatically performs the self test at power on/off or
power cord connection/disconnection, every day or every month.
Operation when an abnormality is detected:
The status indicator is set to the disabled condition (red).
Basic Checks
This mode enables easy daily inspection.
SD card check: To check whether an SD card can be written and read. The remaining
capacity can also be checked.
System check: To check whether there is an error history.
Paddle check: To check the type of paddles connected to the paddle connector.
Defibrillation check: To check the capacity of the high-pressure condenser. By
discharging
to the external paddles or to the test load connected, the supplied
energy, TTR, and charge time are measured for normal or abnormal
determination.
Pacing check: To check a pacing output for normal or abnormal determination
(TEC-5631 only).
Status indicator check: To check whether indications of the status indicator change.
Voice check: To check whether voice instructions can be heard.
Alarm check: To check the alarm indicator and alarm sounds.
ECG check: To check whether communication is properly made with the lead ECG
section (except TEC-5601).
Multi-parameter check: To check whether communication is properly made with the
multi
parameter unit (only when QI-564V is connected).
Battery check: To check the battery remaining and expiration date.
Bluetooth® check: To check communication with an external device (only when QI-
832V is
connected).
Recorder check: To check whether data can be normally printed on papers (except
TEC-5601).

Messages
Defibrillation and Cardioversion
AED
Pacing
Monitoring
ECG
 Performing the Basic Checks

3 Press the [START] key to start the basic checks. The checks are started
from the SD card check, and performed in sequence. Proceed with the
checks by pressing the specified keys in accordance with the on-screen
guidance.
For details, refer to the corresponding items mentioned on the subsequent
pages.
From “SD Card Check” (p.4-11) to “Recorder Check (TEC-5602,
TEC-5611, TEC-5621, TEC-5631)” (p.4-24)
• The item being checked is highlighted on the screen and “CHECKING” is
displayed.
• When the current check is finished, the result is displayed in the right
column for the item and “CHECKING” appears for the next check item.
4 When the basic checks have been completed, the check result window is
displayed and the all results are recorded.
NOTE: Make sure that the date and time printed on the recording
paper are correct. The dates and times on the recording
paper are important parts of the medical records.

SD Card Check
The defibrillator performs writing/reading check to the SD card.
When “Basic Check Type” is set to “Detailed” on the SYSTEM SETUP screen,
the capacity (remaining) of the SD card is also checked.

Sd check
Out of paper check