UM DKI-N-11 (EN, 2024)

DEFIBRILLATOR MONITOR
DKI-N-11 AXION
as per TU 9444-162-07530936-2008
User Manual
TABLE OF CONTENTS
1 DESCRIPTION AND OPERATION .......................................................................... 4
1.1 Symbols ................................................................................................................ 4
1.2 Purpose ................................................................................................................. 7
1.3 Technical Parameters .......................................................................................... 10
1.4 Design and Principle of Operation ..................................................................... 21
2 DELIVERY SET ....................................................................................................... 29
3 SAFETY PRECAUTIONS ....................................................................................... 41
4 INTENDED USE ...................................................................................................... 43
4.1 Operation Modes ................................................................................................ 43
4.2 Screen Views ...................................................................................................... 43
4.3 Pre-Starting Procedures ...................................................................................... 46
4.4 Turning the Device On and Off .......................................................................... 46
5 MANUAL DEFIBRILLATION ................................................................................ 56
5.1 Selecting the Energy Level ................................................................................. 57
5.2 Energy Gain ........................................................................................................ 58
5.3 Applying the Defibrillation Electrodes .............................................................. 59
5.4 Discharging ......................................................................................................... 60
5.5 Paediatric Electrodes .......................................................................................... 62
5.6 Synchronized and Asynchronous Defibrillation Modes .................................... 63
5.7 Automatic External Defibrillation ...................................................................... 66
6 OPERATION PROCEDURE .................................................................................... 70
6.1 ECG Path Operation Procedure .......................................................................... 70
6.2 Recorder Operation Procedure ........................................................................... 77
6.3 Using the Device in the MONITOR Mode ........................................................ 80
6.4 Pacing Channel Operation Procedure ................................................................. 87
7 MAINTENANCE ...................................................................................................... 97
8 TYPICAL FAULTS AND TROUBLESHOOTING .............................................. 102
9 STORAGE AND TRANSPORTATION ................................................................ 104
10 ACCEPTANCE CERTIFICATE .......................................................................... 105
11 MANUFACTURER'S WARRANTY ................................................................... 106
12 DISPOSAL DETAILS .......................................................................................... 108
13 DECLARATION OF ELECTROMAGNETIC COMPATIBILITY LEVELS .... 109
14 LIST OF APPLICABLE STANDARDS .............................................................. 115
2
This User Manual covers the design of the Defibrillator Monitor DKI-N-11
AXION as per TU 9444-162-075309362008 (hereinafter referred to as the device),
rules of its application and maintenance procedures.
Due to the constant technical improvement of the device, there may be non-
principal changes in its components that are not reflected herein and do not affect quality
and performance of the device.
CAUTION!
The device is not intended for at-home use and must be used only by a physician.
Do not start working with the device without having studied the User Manual.
Manufacturer's address:
Concern Axion Ltd.
426000, the Udmurt Republic, Russia
90 Gorkogo street, Izhevsk Phone: 7(3412) 51-24-20,
Fax: 7(3412) 51-24-23
3
1 DESCRIPTION AND OPERATION
1.1 Symbols
- manufacturer’s trademark
Defibrillator Monitor DKI- - product name

N-11
- manufacturer's address
- serial number
- date of manufacture
- Eurasian Conformity mark
12.0 to 16.8 V 9.8 A - DC voltage (12.0 to 16.8) V, 9.8 A DC (input);

10.5 to 15.3 V 9.8 A - DC voltage (10.5 to 15.3) V, 9.8 A DC (output);
- input;
- output;
- safety class II
~ 190-250V - supply voltage
50-60 Hz - AC frequency
210VA - power consumption
- warning (Danger! Read and understand the supporting
documentation)
- warning (Caution! Read and understand the supporting
documentation)
- User Manual
- type CF, the input is protected from defibrillation
- type CF
4
- type BF
- type BF, the input is protected from defibrillation
- subject to disposal according to applicable regulations
- dangerous electrical voltage (high voltage)
IP44 - degree of protection against foreign bodies and water ingress

Li-Ion 14.8 V, - battery type
4,400 mA h
- protect the battery against strong heating or open flame, do not
burn the battery off
- do not deform the battery or open its case
SW version 0.0.7 - software version

- avoid exposure to sunlight
- latex free
- not reusable
- non-sterile
5
- certified by a notified body
- lot No.
- best before (usage end date)
- temperature limit (operating temperature)
- humidity range
6
1.2 Purpose
The Defibrillator Monitor DKI-N-11 AXION (hereinafter referred to as the
device) is designed for therapeutic intervention on the heart with a single bidirectional
(biphasic) electric pulse through a pair of electrodes, transthoracic, as well as to monitor
and record the electrocardiogram (ECG) of the patient, both from defibrillation
electrodes, and separate ECG electrodes. The device allows you to determine the arterial
oxygen saturation (SPO2), monitor arterial blood pressure (ABP) as well as perform
external (ECP), intra-esophageal (IECP), and endocardial cardiac pacing (ENDO). The
device has manual defibrillation and automatic external defibrillation (AED) modes and
allows connection of disposable flexible or reusable defibrillation electrodes.
It can be used in medical hospitals, cardiology dispensaries, for equipping
ambulance and emergency medical teams.
Intended users:
The device shall be used only by medical staff having appropriate qualification. It
shall be used only by those who have completed training on its use.
Persons who are not authorized for this or who have not completed appropriate
training must not use it.
Indications for use:
1 The defibrillator shall be used for emergency defibrillation for patients having
cardiac arrest defined by the following signs:
- losing consciousness;
- no normal breathing;
- other signs of circulatory arrest.
2 The indications for cardiac pacing are
- bradycardia;
- tachycardia control;
- prophylactic fitting.
3 The indications for endocardial cardiac pacing are
- emergency treatment of arrhythmias and heart block;
- emergency cardiac pacing;
7
- stabilization of hemodynamic parameters in bradycardia occurring in the acute
myocardial infarction;
- resuscitation measures;
- transportation of a patient with hemodynamically significant bradycardia.
4 The indications for intra-esophageal cardiac pacing are
- heart pounding attacks that are not recorded during 24-hour ECG monitoring;
- slow pulse events, followed by heart pounding attacks;
- continuous slow pulse;
- fainting fits and dizziness, especially in young people;
- WPW syndrome;
- study of various characteristics of paroxysmal supraventricular arrhythmia for
diagnosed patients;
- efficacy evaluation of antiarrhythmic treatment, including surgical treatment;
- in some cases, diagnostics of coronary heart disease.
Contraindications for use:

1 The device shall not be used for emergency defibrillation if a patient:
- is conscious;
- breathes normally;
- has a detectable pulse and other signs of adequate blood circulation.
2 The contraindications for endocardial cardiac pacing are
- Paget syndrome: a central venous access is used on the unaffected side;
- low blood coagulation after thrombolytic therapy. High-level mastery of central
vein catheterization technique avoids bleeding;
- artificial tricuspid valve. Careful manipulations avoid mechanical trauma to the
valve;
- cardiac arrest for more than 20 minutes. Low probability of successful
resuscitation.
3 The contraindications for intra-esophageal cardiac pacing are
- the patient's refusal or intense neurotic reaction to the electrode introduction;
8
- esophageal diseases (tumours, esophagostenosis, esophagitis in the acute stage,
esophageal polyps);
- acute conditions, including those accompanied by fever;
- difficulty of nasal breathing;
- atrial fibrillation at the time of the test;
- type II and III atrioventricular heart block (diagnosed using ECG);
- an intracardial clot (detected using heart ultrasound).
The device allows you to monitor with the built-in TFT-display and record on a
paper tape:
- the patient's ECG, both from defibrillation electrodes, and separate patient-cable
electrodes, heart rate, rhythmograms and scattergrams of R-R intervals;
- preset and gained discharge energy;
- current time and date;
- arterial oxygen saturation SpO2, pulse rate;
- arterial blood pressure (ABP).
The device allows you to perform external, intra-esophageal, and endocardial
cardiac pacing.
It gives an alarm when heart rate, pulse rate, or SpO2 exceeds the pre-set limits.
The device is classified as a portable device designed for operation in mobile
medical equipment, resistant to vibrations within the frequency range of 10 to 55 Hz at
the displacement amplitude of 0.35 mm and to shock at the peak shock acceleration of
10 g and duration of shock acceleration of 16 ms. The device is manufactured as a class
II device with an internal power source and working parts of the following type:
- BF for defibrillation electrodes;
- CF with defibrillation discharge protection for the individual electrodes of the
monitor;
- BF with defibrillation discharge protection via the ABP control channel;
- BF for the SpO2 control channel;
- CF for pacing channel. Operating conditions:
- ambient temperature: 0 ˚С to plus 40 ˚С;
9
- relative air humidity: up to 98 % at plus 25 ˚С;
- atmospheric pressure: 630 to 800 mm Hg (83.9 to 106.6 kPa).
The device can be used in medical hospitals, cardiology dispensaries, to provide
medical care at home and in an ambulance car.
1.3 Technical Parameters

1.3.1 Device components:
a) a defibrillator monitor unit with reusable electrodes for external defibrillation
of paediatric patients and adults, ECG, SPO2, ABP, pacing channels, a recorder, and a
152х91-mm colour display with resolution of (800х480) pixels;
b) a plug-in Li-Ion battery;
c) a power cord;
d) an ECG cable to take ECG;
e) disposable and reusable ECG electrodes;
f) a cuff for the ABP channel;
g) a cuff-type SPO2 sensor for adults;
h) multifunctional electrodes, for adults and paediatric patients, designed for
resuscitation measures. The multifunctional electrodes are non-sterile and
recommended for single use. The multifunctional electrodes are not intended to be re-
used; i) a power adapter.
1.3.2 A defibrillation pulse is a bidirectional trapezoidal asymmetrical time-
limited (BTTL) pulse with the negative-to-positive half-wave current amplitude ratio of
(0.5±0.1) at the load of 50 Ohm.
The pulse parameters within the load range of 25 to 175 Ohm:
a) length of each half-wave for energy of 250, 300, and 360 J: (6±1) ms;
length of positive and negative half-waves for energy of up to 250 J: (4±1) ms and
(4±0.3) ms, respectively;
b) build-up time for both half-waves: (8 to 400) µs;
c) distance between the half-wave pulses: (0.3 to 1.0) ms.
10
The use of the pulse waveform showed in Figure 1 allows you to conduct effective
defibrillation and cardioversion in case of atrial fibrillation with less energy as
compared to that expended when unidirectional pulses are used.
The bidirectional trapezoidal asymmetrical pulse provides high survival in
patients after the circulatory arrest due to ventricular fibrillation or ventricular
tachycardia, through the use of highly-effective pulse energy that has more sparing
effect on the heart tissues.
Figure 1
1.3.3 The maximum energy at the load of 50 Ohm is (360±54) J.
11
1.3.4 The device provides the following energy values set discretely:
Table 1
Pre-set Load energy, J
energy Load resistance, Ohm Allowable
25 50 75 100 125 150 175 deviation
2 2 2 2 2 2 2 2 ±2 J
5 5 5 5 5 5 4 4 ±3 J
10 10 10 10 10 10 9 8
25 25 25 25 25 25 20 18 ±15 %
50 50 50 50 50 50 45 40
75 75 75 75 75 75 65 60
100 100 100 100 100 100 90 80
150 100 150 150 150 150 135 120
200 100 200 200 200 200 180 160
250 100 250 250 250 230 210 190
300 100 300 300 280 250 230 210
360 100 360 320 300 270 250 225
1.3.5 Energy gain time with a new, fully charged battery or the mains voltage of
(190 to 250) V:
- no more than 6 s for 200 J;
- no more than 10 s for 360 J.
The time of 360-J energy gain with a battery after 15 discharges with the energy
of 360 J is no more than 15 s.
The time from initial turning on of the device to full charge of 360 J at the mains
voltage of (190 to 250) V or with a battery after five discharges with the energy of 360 J
is no more than 25 s.
1.3.6 The device limits the defibrillation current at the patient's resistance of less
than 25 Ohm to (30±10) A.
1.3.7 The device blocks the energy gain and output at the patient's resistance of
less than 12 Ohm or over 200 Ohm as well as when the electrodes are open or closed,
with a relevant information displayed and a voice message delivered.
1.3.8 The defibrillation pulse is delivered by pressing the "DISCHARGE" buttons
or in synch with R-wave.
12
1.3.9 The accumulated energy is automatically discharged to the internal load in
30 s after it is gained.
1.3.10 To discharge the accumulated energy to the internal load forcefully when
you refuse to defibrillate, press the "CANCEL" button.
1.3.11 Visual and audible signalling of the energy gain and storage processes is
provided. Voice prompting is provided as well.
1.3.12 A ALARM signal is generated in case of failure of high-voltage part of the
device.
1.3.13 When powered by a fully charged battery, the device provides, on the OR
basis:
a) at least 5 hours of operation in the monitoring mode;
b) at least 100 energy discharges of 200 J;
c) at least 70 energy discharges of 360 J.
The time of continuous AC mains operation is at least 168 hours.
1.3.14 A built-in artificial load with an output energy indicator is provided.
1.3.15 Power supply of the device:
a) AC mains with the voltage of (190-250) V and the frequency of (50-60) Hz.
The mains power consumption is no more than 210 VA;
b) the device can be powered by an external DC power supply with the voltage of
(12.0-16.8) V, such as a car battery not connected to the on-board electric system of the
car or other DC power supply complying with requirements of GOST R IEC 60601-1.
Herewith, the device provides the current consumption of no more than 9.8 A;
c) a plug-in Li-Ion battery of 14.8 V, 4,400 mAh;
d) a built-in battery charger with automatic cut-out. The battery charging time is
no more than 5 hours.
1.3.16 The device has two channels for receiving ECG from the defibrillation
electrodes and from the cardiographic electrodes of the monitor, combined on the OR
basis, with the sensitivity of 5, 10, 20 mm/mV.
The ECG monitoring is provided via a 4-channel ECG cable (aVR...aVF leads)
and via a 10-channel ECG cable (aVR...aVF, V1...V6 leads).
The rate of the waveform scanning on the display screen is 12.5, 25, 50 mm/s.
13
The heart rate measurement range is 30 to 300 beats/min, whereas the heart rate
alarm limits are set to 30 to 240 beats/min.
An anti-tremor filter and a power filter that can be disabled are provided. The pulse
rhythmograms and scattergrams are generated.
1.3.17 Pulse oximetry channel
The range of SpO2 readings is (0 to 100) %. The absolute error is ±3 % within the
reading range of (75 to 100) %.
The pulse rate is monitored within the range of (30 to 240) beats/min.
The SpO2 setting time is no more than 10 s.
The alarm limit setting range is (30 to 240) beats/min for pulse rate and (75 to
99) % for SpO2 (lower).
1.3.18 NIBP channel
The cuff pressure measurement range is (20 to 280) mm Hg with the absolute error
of ±3 mm Hg.
The average speed of drop in the cuff pressure in the measurement mode is (2 to
5) mm Hg/s.
The operating level of the emergency release channel is 300 to 330 (150 to 165)*
mm Hg.
The maximum time of the cuff pressure exceeding 15 (5)* mm Hg is no more than
180 (90)* s.
Note. The values with an asterisk (*) are specified for the paediatric mode.
1.3.19 The following data are displayed at the screen: pre-set energy, one of the
ECG channels, status of the replaceable battery (four levels), number of the selected
lead, upper and lower alarm limits for heart rate and the current value, energy
accumulation process, current time and date, the recorder mode, the current output, and
resistance of the patient's chest. When the pulse oximetry channel is used, a
photoplethysmogram, the pulse rate, and SpO2 value are additionally displayed.
When the NIBP channel is used, the values of systolic, diastolic, and mean blood
pressure are additionally displayed.
When the pacing channel is used, the pre-set mode and parameters of the pacing
pulses are displayed.
14
1.3.20 Electric cardial pacemaker channel
The channel supports three types of cardiac pacing:
- external cardiac pacing (ECP);
- intra-esophageal cardiac pacing (IECP); and
- endocardial cardiac pacing (ENDO).
The mode is set automatically as a relevant pacing cable is connected.
A pacing mode can be selected on the screen menu:
- Fixed;
- Overdrive;
- Demand.
The pulse repetition rate for all pacing types in the Fixed and Demand modes is
(40 to 180) pulses/min with the setting increment of 10 pulses/min. The relative rate
error in the entire range shall be within ±3 %.
The pulse repetition rate in the Overdrive mode is
a) (40 to 250) pulses/min with the setting increment of 10 pulses/min for ECP.
The relative rate error in the entire range shall be within ±3 %;
b) (40 to 900) pulses/min with the following setting increments, for IECP and
ENDO:
- 10 pulses/min within the range of (40 to 200) pulses/min;
- 40 pulses/min within the range of (200 to 400) pulses/min;
- 100 pulses/min within the range of (400 to 900) pulses/min.
The relative rate error in the entire range shall be within ±3 %.
The pulse parameters are as follows:
a) for ECP:
- duration: (20 to 40) ms, with the setting increment of 5 ms. The relative error in
the entire range of the pulse duration shall be within ±5 %;
- amplitude of the pre-set current in the pulse: (10, 20, 40, 80, 120, 160, 180) mA
at the load of 500 Ohm±0.5 %. The relative error within the entire current range is
±10 %;
- authorized load range: (100 to 500) Ohm.
b) for IECP:
15
- duration: (5, 10) ms. The relative error within the entire range of the pulse
duration is ±5 %;
- amplitude of the pre-set current in the pulse: (4 to 50) mA at the load of
1 kOhm±0.5 % with the setting increment of 2 mA. The relative error within the entire
current range is ±10 %;
- authorized load range: (700 to 1,300) Ohm.
c) for ENDO:
- duration: 0.5, 1 ms. The relative error within the entire range of the pulse duration
is ±10 %;
- amplitude of the pre-set current in the pulse: (4 to 20) mA at the load of
500 Ohm±0.5 % with the setting increment of 2 mA. The relative error within the entire
current range is ±10 %;
- authorized load range: (400 to 600) Ohm.
For all modes, the pulses are rectangular, with the overshoot and ripple on the top
equal to no more than ±10 % and the build-up time of no more than 0.2 ms.
1.3.21 AED mode

The defibrillation energy for the first and the subsequent discharges is as follows:
- 100 J, 150 J, and 200 J for the adult mode;
- 50 J, 75 J, and 100 J for the paediatric mode.
The values above can be changed by the operator. The time to discharge with the
energy of 360 J shall not exceed:
- 30 s from the activation of the rhythm detector;
- 40 s from the time of turning on or any other moment within the operator-
programmed mode, under the following conditions:
- when powered by the mains with the voltage of 90 % of the rated value; - when
the battery is discharged by 15 discharges of 360 J.
The sensitivity of the rhythm detector is over 75 % for detection of ventricular
tachycardia with different amplitude values and QRS width and over 90 % for detection
of rhythm of ventricular fibrillation with different amplitude values.
16
The detector specificity for correct detection of rhythms not subject to
defibrillation is over 95 %.
1.3.22 The recorder allows you to print the screen information on paper. The paper
feed rate of the recorder is 12.5, 25, 50 mm/s. The paper width is (57 to 58) mm, the
roll diameter is no more than 50 mm. Thermal paper with or without the grid can be
used.
1.3.23 The weight of the portable part (a defibrillation and monitor unit) of the
device is no more than 7 kg, with the battery installed.
1.3.24 The overall dimensions of the portable part of the device are no more than
(345х230х345) mm.
1.3.25 The ambient conditions are provided in Table 4.
Table 4 – Ambient conditions
Characteristics of Operational
Operating Transportation Storage
ambient transportation
conditions conditions conditions
conditions conditions
0 °C to plus minus 50 °C to plus 5 °C to
Temperature 0 °C to plus 40 °C
40 °C plus 50 °C plus 40 °C
no more than no more than no more than no more than
Relative humidity
98 % at plus 98 % at plus 98 % at plus 80 % at plus
(non-condensing)
25 °C 25 °C 25 °C 25 °C
Atmospheric
630 to 800 mmHg (84 to 106.7 kPa)
pressure
1.3.26 The software version is at least 0.0.7.

1.3.27 The average service life of the device is at least 5 years.
1.3.28 Marking
1.3.28.1 The device is marked in compliance with requirements of GOST
R 50444, GOST R IEC 60601-1, GOST R IEC 60601-2-4, GOST R ISO 15223-1.
1.3.28.2 The defibrillator monitor unit is marked with
- manufacturer’s trademark;
- device name;
- designation of the Technical Specifications;
- symbol 5.1.1 "Manufacturer" according to GOST R ISO 15223-1 with the
manufacturer's name and address next to it;
- "Made in Russia" lettering;
17
- "Defibrillator Monitor Unit" lettering;
- symbol 5.1.7 "Serial No." according to GOST R ISO 15223-1, with the serial
No. under the manufacturer's numbering system next to it;
- symbol 5.1.3 "Date of manufacturer" according to GOST R ISO 15223-1, with
the date of manufacture according to GOST R 7.0.64 next to it;
- Eurasian Conformity mark "ЕАС";
- degree of protection against foreign bodies and water ingress: IP44;
- type BF;
- symbol 5.4.4 "Warning" according to GOST R ISO 15223-1;
- a symbol for class II devices according to GOST R IEC 60601-1;
- symbol "User Manual" according to GOST R ISO 15223-1;
- symbol "Special disposal";
- the following data are marked near the AC mains connector:
- symbol "AC" according to GOST R IEC 60601-1;
- input voltage range;
- AC frequency range;
- power consumption;
- battery type, rated voltage, and capacity;
- software version No. and release date;
- the following symbols are applied near the defibrillation electrode connector:
- type BF, the input is protected from defibrillation;
- dangerous electrical voltage (high voltage);
- the front and side panels of the defibrillator monitor unit as well as electrodes
have labelling of the controls and indicators, safety signs.
1.3.28.3 The battery is marked with
- "Battery" lettering;
- seq. No. under the manufacturer's numbering system;
- date of manufacture;
- battery type, rated voltage, and capacity;
18
- symbol "Warning" according to GOST R ISO 15223-1;
- brief operating instructions;
- a symbol of the battery protection against strong heating or open flame;
- a symbol of the battery protection against deformation.
1.3.28.4 The power adapter is marked with
- "Power Adapter" lettering;
- symbols of input and output parameters, specifying the input and output voltage
range, input and output current;
- symbol "DC" according to GOST R IEC 60601-1;
- symbol 5.4.4 "Warning" according to GOST R ISO 15223-1;
- brief operating instructions.
1.3.28.5 The disposable multifunctional defibrillation electrodes for adults
PG10S/RU7959 and paediatric patients PG10S/RU7959P shall be marked with
- "Disposable Multifunctional Defibrillation Electrodes" lettering;
- electrode model and type: for adult or paediatric patients;
- type of the defibrillator connector;
- dimensions;
- storage conditions;
- symbol "Lot No." according to GOST R ISO 15223-1, with the serial No. under
the manufacturer's numbering system next to it;
- symbol "Date of manufacturer" according to GOST R ISO 15223-1, with the
date of manufacture according to GOST R 7.0.64 next to it;
19
- symbol "Best before" according to GOST R ISO 15223-1, with the usage end
date next to it;
- a complete list of the electrode functions;
- a warning to open the package immediately before use;
- brief instructions for use;
- symbol "Temperature limit" according to GOST R ISO 15223-1;
- symbol "Humidity range" according to GOST R ISO 15223-1;
- symbol "Warning" according to GOST R ISO 15223-1;
- symbol "Avoid exposure to sunlight" according to GOST R ISO 15223-1;
- symbol "Latex free" according to GOST R ISO 15223-1;
- symbol "Not reusable" according to GOST R ISO 15223-1;
- symbol "Non-sterile" according to GOST R ISO 15223-1;
- CE mark.
1.3.28.6 The other components are marked with
- name;
1.3.28.7 The consumer package is marked with
- device name;
- designation of the Technical Specifications;
- serial number of the device;
- date of the device manufacture;
- year and month of packaging;
- transportation and storage conditions;
- guaranteed shelf life;
- manufacturer's address;
20
- handling symbols: "Fragile. Handle with care", "Up", "Protect from moisture",
"Stacking limited: 15 kg max" according to GOST 14192.
The marking is applied by printing on labels.
1.3.29 Packaging
1.3.29.1 The device packaging corresponds to protection option B3-10 as per
GOST 9.014.
1.3.29.2 The device is packed in a consumer package.
1.3.29.3 Cardboard boxes are used as the consumer package.
The device is put inside a PE bag as per GOST 10354, at least 0.1 mm thick, and
the bag is sealed. The device packed in a bag is placed in the consumer package.
The operational documentation is put inside a PE bag as per GOST 10354, at least
0.1 mm thick, and the bag is sealed. It may be put inside a ZIP-LOCK bag.
The box with the packed device inside is covered with a PE tape with an adhesive
layer as per GOST 20477.
1.4 Design and Principle of Operation

1.4.1 A structural diagram of the device is shown in Figure 2.
Voltage from the mains converter (1) or a battery (3) is supplied for power supply
to a charger of the energy storage capacitors (7) and via the ON switch to a DC-DC
voltage-source converter (6) to generate supply voltage for all components of the
device. A control unit (5) is built based on microcontrollers and designed to control
operation of all device components. It receives control commands from the front panel
(4) of the device.
21
1 - Network converter;
2 - Battery charger;
3 - Battery;
4 - Control pannel;
5 - Apparatus control device;
6 - DC-DC converter;
7 - Power capacitors charger;
8 - Display;
9 - Recorder;
10 - Voice communication recorder;
11 - Biopotential amplifier;
12 - Pulse oximetry channel;
13 -NIBP channel;
14 - High-voltage commutator;
15 - ECS channel.
Figure 2 – Structure scheme of defibrillator
22
1.4.2 General view of the device and its controls is shown in Figures 3 (a, b, c, d,
e).
a)
b) c)
d)
23
e)
1 - device on/off button;

2 - energy gain button;
3 - energy delivery button;
4 - forced energy discharge button;
5 - indicator of energy discharged to the internal load;
6 - energy increase button;
7 - energy decrease button;
8 - print control button;
9 - micro SD memory card;
10 - battery charge indicator;
11 - mains supply switching-on indicator;
12 - operating mode selection button;
13 - five on-screen menu buttons;
14 - display;
15 - ECG cable connector;
16 - pulseoxymetry sensor connector;
17 - pacing electrode connector;
18 - cuff sleeve;
19 - defibrillation electrode connector;
20 - sternum electrode;
21 - apex electrode;
22 - power cable connector;
23 - switch
Figure 3 – General view of the device and its controls
24
1.4.3 Micro SD memory card
1.4.3.1 A micro SD memory card is not included in the product package and shall
be purchased by users at their discretion, with a capacity of 4 GB or more.
The memory card shall be inserted in the device before turning it on, since the card
is detected and initialized during the initial testing of the device after it is turned on. The
availability of the memory card is indicated in the upper right area of the screen.
To insert the micro SD memory card, open a plug on the front panel of
the device.
Then insert the memory card into the slot, with the contacts upwards, and close
the plug (Figure 4).
Figure 4
The defibrillator data are recorded to the memory card upon the following events:
- automatically, after defibrillation;
- automatically, upon actuation of heart/pulse rate or
SpO2 alarm;
- manually, by pressing the "Save" menu button in the rhythmogram and
scattergram view mode.
The following data is stored on the memory card:
- date and time;
25
- discharge energy;
- patient impedance and discharge current;
- values of heart rate, pulse rate, SpO2, ADC, ADD;
- waveforms (ECG, PPG) with the duration of 4 s before and 5 s after the event;
- rhythmogram and scattergram;
- battery status.
1.4.3.2 Desktop computer operation procedure

The desktop computer operation procedure is stated in the Operator's Manual,
which is stored in electronic format on a CD together with the software.
To install the software and create a data archive, the desktop computer shall be
compatible with the IBM PC.
Minimum desktop computer requirements:
- operating system: Windows 2000 or higher;
- RAM: 512 Mbyte;
- hard disk memory: at least 200 Mbyte.
26
1.4.4 Battery status monitoring The battery status is indicated in the right upper
portion of the screen, as shown in Figure 5.
There are four battery status levels:
- four bars mean 100 % of the battery charge;
- three bars (green) mean 75 % of the battery charge;
- two bars (yellow) mean 50 % of the battery charge;
- one bar (red) means 25 % of the battery charge;
When the "CHARGE THE BATTERY" message appears for the first time, you
can still perform three discharges with the maximum energy. If the message appears,
charge or replace the battery. If the battery charge drops below 25 %, the "CHARGE
THE BATTERY" message will appear, followed by the
"THE DEVICE WILL TURN OFF IN 20 SECONDS" voice message; herewith,
the energy gain is blocked, and the device with automatically turn off in 20 s.
CAUTION! Constantly monitor the battery status and keep it charged. When the
battery charge is 50 %, it is guaranteed that energy of 200 J can be gained at least
30 times.
1.4.5 Battery charging
1.4.5.1 The batteries shall be charged at the temperature of 0 to plus 40 °C. The
optimum battery charge is provided at the ambient temperature of plus 15 to plus 25 °C,
when a fully discharged battery is charged. The battery charging time is no more than
5 hours from the time when the following indicator lights up:
1.4.5.2 Place the battery into the compartment in the lower part of the front panel
of the device (Figures 6 a, b, c). Connect the mains cable to a connector on the rear
panel of the device (Figure 9) and the cable plug to a ~220 V power socket. Set the
switch on the rear panel of the device to the On position
(Figure 10) and check that the switch indicator and the indicator on the
front panel light up as well as the battery status indicator turns on in 5-6 s. The
27
battery charging time is no more than 5 hours. When you turn the device on by pressing
the ON/OFF button, the charging stops.
When the charging time is up, the indicator turns off. If the charger is
faulty, the indicator switches to the intermittent flashing mode (error code) with
the interval of approximately 2 s.

1.4.5.3 After long-term storage of the device (over 6 months), perform several
successive charging-discharge cycles to restore full capacity of the battery according to
7.3.
1.4.5.4 The device uses Li-Ion batteries with the voltage of 14.8 V and capacity
of at least 4,400 mA h.
CAUTION! Remove the battery pack from the device during its transportation or
long-term storage.
28
2 DELIVERY SET
2.1 The device versions and designations in the design documentation are
provided in Table 2.
Table 2
Seq. Defibrillator Monitor DKI-N-11 AXION NIBP SPO2 Cardiac AED
No. (Defibrillator Monitor Unit) pacing
1 UMGI.941135.009-12 + + + -
(UMGI.941135.013-04)
2 UMGI.941135.009-20 + + - -
(UMGI.941135.013-07)
3 UMGI.941135.009-21 - - - -
(UMGI.941135.013-09)
4 UMGI.941135.009-16 + + + +
(UMGI.941135.020-03)
5 UMGI.941135.009-19 + + - +
(UMGI.941135.020-05)
6 UMGI.941135.009-18 - - - +
(UMGI.941135.020-04)
CAUTION!
If your Defibrillator Monitor DKI-N-11 does not have additional SpO2, pacing,
NIBP, or AED data monitoring features, ignore the relevant controls and information
stated in the applicable chapters hereof.
29
2.2 The delivery set of the device in version UMGI.941135.009-12 matches that
provided in Table 3.1.
Table 3.1
Description Document designation Q-ty, pcs Remark
1. Defibrillator monitor unit UMGI.941135.013-04 1
2. Battery UMGI.687291.010-01 1
3. Power cord UMGI.685622.048-01 1
4. ECG cable 4/12 UMGI.685622.033-01 1 to take ECG
5. Disposable ECG - 50 for the ECG channel
electrodes: a disposable
electrode made of elastic
textile plaster (for active
patients), 43x45 mm
РУ No. ФСЗ 2010/07536
6. Disposable ECG electrode 50*) for the ECG channel
by NIKA MEDICAL as per
TU 26.60.12-001-07539541-
2016
РУ No. РЗН 2018/7070
7. Paper recording tape 1 roll 57 mm-wide, 23 m-
long
8. Cuff UMGI.943133.007-01 1 for the ABP channel
9. Cuff-type SPO2 sensor for UMGI.685612.098-01 1 for the SPO2 channel
adults
10. ECP adapter cable UMGI.685622.028-02 1 for ECP
11. Disposable multi- 1 set for the ECP channel
functional defibrillation -
electrodes for adults
PG10S/RU7959
12. Power adapter UMGI.468824.018 1*)
13. Adapter cable for UMGI.685622.029-02 1*)
endocardial cardiac pacing
30
Table 3.1 (continued)
14. Temporary endocardial 1*)
electrodes for external
electric cardial pacemakers
ELVI and peel-away
introducers with accessories
as per TU 9444-014-
45934527-2006: ELVI model
214-100 РУ No. РЗН
2013/467
15. Adapter cable for intra- UMGI.685622.030-02 1*)
esophageal cardiac pacing
16. Electrodes for intra- 1*)
EP-01-DM-S-PT, version:
bipolar electrode EP2-01-
"DMS-PT" as per TU 9444-
001-46816787-2004 РУ
No. РЗН 2015/2784
17. Patient cable UMGI.685622.034-01 1*) 10 leads
18. Reusable ECG electrode 6*)
made of "silver-silver
chloride" alloy, model:
F9009SSC РУ No. ФСЗ
2010/07536
made of "silver-silver
chloride" alloy, model:
2010/07536
20. User Manual 1
21. DKI-N-11 carry bag UMGI.323369.022 GCh 1
22. Defibrillator DKI-N-11 UMGI.323382.002 GCh 1*)
pouch
*) - supplied on an as-needed basis
31
Table 3.2
1. Defibrillator monitor UMGI.941135.013-07 1
unit
2. Battery UMGI.687291.010-01 1
3. Power cord UMGI.685622.048-01 1
5. Disposable ECG 50 for the ECG channel
patients), 43х45 mm РУ
No. ФСЗ 2010/07536
6. Disposable ECG 50*) for the ECG channel
electrode by NIKA
MEDICAL as per
TU 26.60.12-001-
07539541-2016
РУ No. РЗН 2018/7070
long
9. Cuff-type SPO2 sensor UMGI.685612.098-01 1 for the SPO2 channel
for adults
12. Reusable ECG 6*)
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9009SSC
РУ No. ФСЗ 2010/07536
32
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9024SSC РУ
No. ФСЗ 2010/07536
14. User Manual 1
pouch
Table 3.3
unit
2. Battery UMGI.687291.010-01 1
3. Power cord UMGI.685622.048-01 1
textile plaster (for active -
No. ФСЗ 2010/07536
33
electrode by NIKA
MEDICAL as per
TU 26.60.12-001-
07539541-2016
РУ No. РЗН 2018/7070
long
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9009SSC
РУ No. ФСЗ 2010/07536
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9024SSC
РУ No. ФСЗ 2010/07536
12. User Manual 1
14. Defibrillator DKI-N- UMGI.323382.002 GCh 1*)
11 pouch
34
Table 3.4
unit
2. Battery UMGI.687291.010-01 1
3. Power cord UMGI.685622.048-01 1
textile plaster (for active -
No. ФСЗ 2010/07536
electrode by NIKA
MEDICAL as per
TU 26.60.12-001-
07539541-2016
РУ No. РЗН 2018/7070
long
9. Cuff-type SPO2 sensor UMGI.685612.098-01 1 for the SPO2 channel
for adults
10. ECP adapter cable UMGI.685622.028-02 1 for ECP
11. Disposable multi- 1 set for the ECP, AED
functional defibrillation channel
PG10S/RU7959
12. Disposable multi- 1 set*) for the AED channel
functional defibrillation
electrodes for paediatric
patients PG10S/RU7959Р
35
14. Adapter cable for UMGI.685622.029-02 1*)
endocardial cardiac pacing
15. Temporary endocardial 1*)
electrodes for external
electric cardial pacemakers
ELVI and peel-away
introducers with
accessories as per
TU 9444-01445934527-
2006: ELVI model 214-
100 РУ No. РЗН 2013/467
16. Adapter cable for intra- UMGI.685622.030-02 1*)
17. Electrodes for intra- 1*)
EP-01-DMS-PT, version:
bipolar electrode EP2-01-
"DMS-PT" as per
TU 9444-001-46816787-
2004 РУ No. РЗН
2015/2784
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9009SSC
РУ No. ФСЗ 2010/07536
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9024SSC
РУ No. ФСЗ 2010/07536
21. User Manual 1
36
22. DKI-N-11 carry UMGI.323369.022 GCh 1
bag
pouch
Table 3.5
1. Defibrillator monitor unit UMGI.941135.020-05 1
2. Battery UMGI.687291.010-01 1
3. Power cord UMGI.685622.048-01 1
patients), 43х45 mm
РУ No. ФСЗ 2010/07536
6. Disposable ECG electrode 50*) for the ECG channel
by NIKA MEDICAL as per
TU 26.60.12-001-07539541-
2016 РУ No. РЗН 2018/7070
long
9. Cuff-type SPO2 sensor for UMGI.685612.098-01 1 for the SPO2 channel
adults
37
10. Disposable 1 set for the AED channel
multifunctional defibrillation
PG10S/RU7959
made of "SILVER-SILVER
CHLORIDE" alloy, model:
2010/07536
made of "SILVER-SILVER
CHLORIDE" alloy, model:
2010/07536
16. User Manual 1
pouch
38
Table 3.6
unit
2. Battery UMGI.687291.010-01 1
3. Power cord UMGI.685622.048-01 1
No. ФСЗ 2010/07536
electrode by NIKA
MEDICAL as per
TU 26.60.12-001-
07539541-2016
РУ No. РЗН 2018/7070
long
8. Disposable multi- 1 set for the AED channel
PG10S/RU7959
39
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9009SSC
РУ No. ФСЗ 2010/07536
electrode made of
"SILVER-SILVER
CHLORIDE" alloy,
model: F9024SSC
РУ No. ФСЗ 2010/07536
14. User Manual 1
16. Defibrillator DKI-N- UMGI.323382.002 GCh 1*)
11 pouch
40
3 SAFETY PRECAUTIONS
Safety Requirements
Do not start working with the device without having studied the User Manual.
Improper use of the device can lead to significant injuries and death.
The device must not be used in an explosive atmosphere, in the presence of

flammable gas or high oxygen concentration.
The device cannot be used in water or in the rain.
The device may only be used in the configuration provided by the

manufacturer. It is forbidden to use unsuitable accessories.
The device modification is not allowed!
When using the device, all devices that do not have defibrillator discharge
protection shall be disconnected from the patient.
The device shall be used at a distance of more than 2 meters from strong
sources of electromagnetic radiation to exclude the interference effect during
the rhythm analysis.
Do not touch or move the patient during the heart rhythm analysis and
defibrillation in order to avoid incorrect diagnosis of the analyzed rhythm and
electric shock.
3.1 To ensure safety and eliminate the possibility of electrical shock to operators,
the patient, or maintenance personnel,
NEVER
- open the device outside specialized repair shops;
- use the device with mechanical damage to the housing, electrodes, or cables;
- discharge with short-circuited electrodes;
- install or remove the fuses with the device on;
- connect the pacing cable in the defibrillation mode.
41
3.2 The defibrillator is not intended for at-home use and is permitted to be operated
only by the personnel familiarized with the safety regulations for operation of electrical
installations and electronic medical devices. Its use by unauthorized personnel may
result in damages or death of the patient.
3.3 When powered by a DC power supply unit, a car battery not connected to
electrical equipment of the car or a mains supply source complying with the safety
requirements of safety class I or II can be used as an external power supply.
3.4 During defibrillation, avoid any contact between the patient's body parts (bare
scalp or bare skin of limbs), as well as conductive fluids (gel, blood, saline) and metal
objects around the patient (a bed or a stretcher) that are unwanted paths for the
defibrillation current.
3.5 The reusable electrodes are non-sterile and not subject to sterilization. The
electrodes shall be treated as described in 7.2.
42
4 INTENDED USE
4.1 Operation Modes
The defibrillator monitor has four operation modes, each with a configurable
screen view. The operation modes are described in Table 4.
Table 4
Operation mode Screen view Description
Manual defibrillation Manual defibrillation Used for asynchronous and
screen synchronized defibrillation
(cardioversion)
* Automatic external Automatic defibrillation Used for ECG analysis and, if
defibrillation screen required, semi-automatic
defibrillation
Monitoring Monitoring screen Used for monitoring of ECG (6 or
12 leads), SpO2, and non-invasive
blood pressure
* Cardiac pacing Cardiac pacing screen Used for cardiac pacing on
demand or continuously
* - depending on the version, these modes may be unavailable
4.2 Screen Views

The defibrillator monitor's screen is divided into individual sections, which
contents vary according to the operation mode and the function performed (Figure 5).
43
Status section
Parameter section 1
Parameter section 2
Date section
Curve section
Program buttons
Figure 5
Status section
The operation mode, type of the power supply or the battery status, and availability
of a micro SD memory card are displayed in this area.
Parameter section 1
Heart rate (HR), pulse rate (PR), HR and PR alarm limits and status, a metronome
counter are displayed in this area, depending on the operation mode.
44
Parameter section 2
In the monitoring mode, the current and measured systolic, diastolic, and mean
pressure, SpO2 value, SpO2 alarm limits and status are displayed.
In the manual defibrillation mode, an available energy scale, selected energy level,
the patient impedance and current values, the energy gain process scale are displayed.
In the AED mode, pre-set energy values for the first and the subsequent
discharges, the current energy level, the discharge counter, the energy gain process
scale, and text instructions for the operator are displayed.
Date section
The current date and time, text messages are displayed in this area.
Curve section
One or three curves (ECG from the defibrillation electrodes, leads from the patient
cable, a photoplethysmogram) are displayed in this area, depending on the operation
mode.
Program buttons
The program buttons perform the functions shown on the screen above them. The
designations and functions vary according to the operation mode.
45
4.3 Pre-Starting Procedures
4.3.1 In case of long-term discontinuity in the operation, over two weeks, check
the battery status and, if required, charge the battery according to the instructions in
1.4.5.
4.3.2 After a long (over 8 hours) storage of the device at a temperature below
minus 10 °С, keep it at least for 3 hours at normal temperature before using it.
4.3.3 The device is supplied to the customer with the discharged battery; therefore,
charge the battery according to the instructions in 1.4.5.
4.3.4 The fully charged battery retains its capacity for three weeks; its capacity
drops by half after storing the fully charged battery for 1.5 months.
4.4 Turning the Device On and Off

To turn on the device in the battery mode, place the battery into the compartment
on the front panel of the device, according to Figure 6 (a, b, c).
Press the ON/OFF switch on the front panel to turn on the device. When
the device is started, an internal self-test is performed and its result is displayed on the
screen shown in Figure 7, for (3 to 6) s if the test is successful or until any button is
pressed if an error is found.
46
a) b)
c)
Figure 6
47
Testing...
UNK...
RTC ...
UBP ...
NIBP...
SPO2...
SD card...
Figure 7
N o t e s:
1 The version number of the software installed on the device is displayed in the
top line.
2 If there are any faults, the ERROR message appears next to one of the test lines.
In this case, the device can be further operated only after the faults are repaired.
The "Incorrect Date and Time" message that might appear on the screen after the
device is started does not affect its operation. The date and time shall be set manually
(as described in 6.1.3). To fix the error, replace the button cell CR14250BL-AX.
48
The successful test is additionally accompanied by a short sound signal, music,
and the "THE DEFIBRILLATOR IS READY FOR OPERATION" voice message.
Then, the information shown in Figure 8 is displayed.
Figure 8
For operation from the mains, connect the power cable to the connector on the rear
panel of the device (Figure 9) and the cable plug to a ~220 V power socket, set the
switch on the rear panel to the On position (Figure 10), and check that the switch
indicator and the indicator on the front panel light up.
The general view of the power cable is shown in Figure 11.
49
Figure 9
Figure 10
Figure 11
Press the ON/OFF button on the front panel to turn on the device and then
proceed in a similar way as in the battery mode.
50
To turn on the device in the external DC power supply mode (from a car battery),
insert the power adapter UMGI.468824.018 in the place of the battery and connect the
device to 12 V mains.
The power adapter is shown in Figure 12.
Figure 12
Press the ON/OFF button. After the self-test is completed, the display
screen will turn on as in the battery mode, while the " DC" sign rather than the
battery status indicator will appear in the right upper portion.
Note. Monitor status of the external car battery. Its output voltage shall be at least
12 V.
Press the ON/OFF button to turn on the device. Disconnect the cable from
the external battery.
After the defibrillator is turned on, the main menu the functions of which are most
often used during the operation will appear on the screen.
Several menu levels are used to fulfil the required functions. To get to the required
level, press the relevant menu buttons according to Figures 13, 14, 15. To return back,
press the "Exit" menu button.
Additional functions of the on-screen menu buttons that become available when
the button is pressed and held for 2-3 s (until a long sound signal appears):
- the "Volume" button (Settings)–to disable the voice messages; press again to
enable the messages;
51
- the energy level selection button–to authorize selection of the higher
energy levels (250, 300, 360 J);
- the "Filter" button (Settings – ECG)–to turn on and off the 50 Hz band-
elimination filter;
- the button (Settings – Alarms)–to return to the factory HR (120/40) and
SpO2 (85) alarm limit settings.
52
Main menu
Filter*
Synch.
Exit
Pause ECG
Settings Alarms Select
Screen On/Off
Volume 2*
Exit
Exit
Start
Date
Printer Auto
Manu
Exit al
Grid
Exit
The buttons marked with an asterisk (*) have an additional function when pressed
and held.
Figure 13 – Functions of the on-screen menu buttons in the DEFIBRILLATOR mode
53
Main menu
Filter*
Start Graph Save
Exit Rhyth
m.
Pause ECG Scatt.
Settings Alarms On/Off Reset
Screen Select Exit
Volume 2*
Exit
Exit
Start
Auto
Manua
l
Date Grid
Printer
NIBP Exit
Exit
Pressure Gauge
Filter
Paediatr
ic
Start
Exit
and held.
Figure 14 – Functions of the on-screen menu buttons in the MONITOR mode
54
Mode
Pulse/min Filter*
On
Exit
Exit
Select
Main menu On/Off
Cardi
ac Exit Start
pacin
Pause
g
Settings ECG Auto
Alarms Manual
Screen Grid
Volume 2* Date
Exit Printer Exit
Exit
and held.
Figure 15 – Functions of the on-screen menu buttons in the CARDIAC PACING
mode
55
5 MANUAL DEFIBRILLATION
The initial settings of the defibrillator when turned on are

- energy level: 100 J (25 J for the paediatric electrodes);
- asynchronous defibrillation mode;
- medium volume (Volume 3);
- HR sound (memory setting);
- the automatic printing mode is activated (AUTO);
- the HR alarm is disabled.
CAUTION!
Before starting manual defibrillation, make sure that the defibrillation electrodes
are correctly connected (Figure 16 a, b).
a) b)
Figure 16
56
5.1 Selecting the Energy Level
To set the required energy level, press the (decrease) or (increase)
buttons on the front panel of the device or on the electrode. The value will be displayed
on the screen. The energy levels of 5, 10, 25, 50, 75, 100, 150, 200, 250, 360 J are
displayed in the parameter section 2 of the screen.
To go to the area with the higher energy levels of 250 J and more, press and hold
the button (confirmed by a voice message).

To help determine the energy level, you can enable indication of the patient
impedance (Ohm) and the exposure dose (A) in the middle portion of the screen (press
the "Settings – Screen – Ω – A" buttons).
To display the actual values before the energy gain and when discharging, press
the "CHARGE" and the "DISCHARGE" buttons, respectively.
Pressing any of the , , or "CANCEL" buttons clears the
indication of these values. Pressing the "- - Ω - - А" button again disables this indication
mode.
N o t e s:
1 The energy value required for defibrillation or cardioversion depends on height,
weight, and condition of the patient and shall be established by the physician.
2 The device generates a bidirectional asymmetrical defibrillation pulse and, in
this case, no more than 200 J is required.
57
5.2 Energy Gain
The energy gain starts after the "CHARGE" button is pressed on the
electrode or the front panel.

The defibrillation electrodes shall be located in the device compartments (during
a test discharge) or applied to the patient if defibrillation or cardioversion is performed.
When the "CHARGE" button in the middle portion of the screen is

pressed, the "ENERGY GAIN" message appear, accompanied by a tone up beep and a
voice message.
At the time that the "CHARGE" button is pressed, the device measures
the patient's resistance. If the measured resistance is 25 to 200 Ohm, the energy gain is
authorized, and a message confirming that the energy gained is consistent with the pre-
set value appears.
If the measured value is 12 to 25 Ohm, the gained energy will be less than the
value required to provide the patient discharge current of no more than 40 A.
In this case, the gained energy value will be displayed on the screen.
If the measured resistance is less than 12 Ohm, the "SHORT CIRCUIT" message
will be displayed in the middle portion of the screen, and the energy gain will be
blocked. If the measured resistance is over 200 Ohm, the "NO CONTACT" message
will be displayed in the middle portion of the screen; herewith, the energy gain will be
blocked. In this case, check that the electrodes are adequately pressed to the patient.
The duration of the defibrillation pulses remains the same within the entire load
range.
58
The accumulated energy cannot be changed. If the energy has already been gained,
then in order to change the energy level, it shall be discharged to the internal load; to do
so, press the "CANCEL" button and gain the energy again.
If the battery is partially discharged, the energy gain time will somewhat increase.
The device retains the accumulated energy for 30 s. At the same time, the
remaining time is displayed on the screen. When the time is up, an internal discharge is
performed in 5 s, with a voice warning.
CAUTION!
In the event that the high-voltage part of the defibrillator is faulty or the energy
gain time exceeds 15 s, the device generates the ALARM signal and discharges the
accumulated energy to the internal load.
To exit the ALARM mode, turn the device off, turn it on again, and repeat the
energy gain. If the device changes to the ALARM mode again, it shall be repaired.
5.3 Applying the Defibrillation Electrodes

The electrodes shall be applied along the axis of heart. The sternum electrode shall
be applied to the right area of the chest, below the collarbone. The apex electrode shall
be applied to the left area of the chest, along the axillary line, above the apex of heart
(Figure 17).
59
Sternum
electrode
Apex electrode
Figure 17
5.4 Discharging
To discharge, simultaneously press the "DISCHARGE" buttons on the electrodes
(Figure 18) or the "DISCHARGE" button on the front panel.
Figure 18
In the asynchronous mode, the discharge takes place immediately after the buttons
are pressed.
60
In the synchronized mode, the discharge takes place upon the first R wave after
the buttons are pressed. If there is no R wave more than for 3 s, the device displays the
"NO QRS" message in the parameter section 2 of the screen and generates a voice
message.
CAUTION! To ensure safe energy transfer and prevent damage to the patient's
skin, both electrodes shall be pressed to the chest with a force of 8 kg for adults (4 kg
for paediatric patients).
CAUTION! Make sure that the electrodes do not contact each other and there is
no current-conducting objects between them.
CAUTION! Do not touch the patient or the current-conducting equipment during
the defibrillation. All devices that do not have defibrillation protection shall be
disconnected from the patient.
In the event that you refuse to defibrillate, the accumulated energy can be
discharged to the internal load; to do so, press the "CANCEL" button.

For performance check, the device is provided with a built-in artificial load with
an output energy indicator on the front panel.
To check the device performance, place the electrodes in the transportation

position, gain the energy of 200 J, and simultaneously press the "DISCHARGE" buttons
on the electrodes (Figure 18).
Herewith, the output energy indicator will light up for a short period of time, and
the recorder with automatically turn on (in the AUTO mode). Repeat the actions with
the energy of 100 J and make sure that the indicator does not light up during the
discharge.
61
5.5 Paediatric Electrodes
For defibrillation of paediatric patients, the electrodes with the smaller surface
area (Figure 19) shall be used. The paediatric electrodes are inserted in the electrodes
for adults. Remove the big electrodes; to do so, apply a turning force to them along the
axis (Figures 20 a, b, c). Herewith, the relevant indication and the "OPERATION WITH
THE PAEDIATRIC ELECTRODES" voice message appear, the initial energy of 25 J
is set, and the energy levels of over 100 J are blocked.
Figure 19
62
a) b)
c)
Figure 20
5.6 Synchronized and Asynchronous Defibrillation Modes
In the asynchronous mode, the device delivers an electric pulse when the
"DISCHARGE" buttons on the electrodes are simultaneously pressed (rather than in
synch with the R wave of the QRS complex).
The synchronized mode can be operated only when the ECG is received from the
monitor lead cable.
63
To provide the synchronized mode, connect the lead cable to the ECG connector
of the device (6.1).
Then press the I... on-screen menu button to set the required lead. Press the
"Synch." on-screen menu button. If there is the QRS complex, the screen will have the
view shown in Figure 21.
Figure 21
In the synchronized mode, the device delivers an electric pulse upon the first R
wave of the QRS complex after the "DISCHARGE" buttons on the electrodes are
simultaneously pressed. The delay time t between the R wave peak (cardioversion mark)
and start of the defibrillation pulse (discharge mark) is no more than 60 s and is
calculated based on the ECG printout in the automatic printing mode (Figure 22)
according to the following formula (1):
64
S
t= --------- s (1)
V
where
S is the distance between the cardioversion and discharge marks, mm; V is the
paper feed rate, mm/s.
Cardioversion mark
Discharge mark
Figure 22
65
CAUTION!
When you perform cardioversion (synchronized delivery of an electric pulse),
check the screen to make sure that the cardioversion marks clearly relate to R waves of
the QRS complex.
If the patient has developed ventricular fibrillation, remember to disable
synchronization with the QRS complex, since there is none, and the device will not
deliver the electric pulse (discharge).
The synchronized mode turns off after the discharge and when switching to
reception of the ECG signal from the defibrillation electrodes.
5.7 Automatic External Defibrillation

5.7.1 Automatic external defibrillation shall be performed only using flexible
defibrillation electrodes. The general view of the electrodes is shown in Figure 23.
Figure 23
66
CAUTION! To perform automatic external defibrillation, connect the flexible
defibrillation electrodes (Figure 24).
CAUTION! Make sure that the package of the flexible defibrillation electrodes
is intact and that the shelf life specified thereon is not up.
CAUTION! Do not re-use the flexible defibrillation electrodes.
CAUTION! In the AED mode, the device is intended for use only by professional
physicians or personnel of non-medical institutions who have received pre-training in
the use of the defibrillator on courses for performing basic or advanced (qualified) CPR
or other educational courses officially approved and including first aid training from
the point of view of critical care medicine, in accordance with the local legislation.
Figure 24
67
When powered on, the device switches to the AED mode if the reusable electrodes
are deactivated. The screen view is shown in Figure 25.
Figure 25
68
To switch the defibrillator between the automatic and manual modes, press the
"DEFIBRILLATOR AUTO/MANUAL" button.
The connected reusable electrodes block switching to the AED mode, which is
accompanied by the "CHECK THE ELECTRODES" voice warning. The type of the
disposable flexible electrodes (for adults, paediatric patients) shall be selected by the
operator using a function key of the menu.
When the "CHARGE" button is pressed and held, the device switches to
the mode of setting the energy for the first and the subsequent discharges.
Pressing the "CHARGE" button shortly allows you to select the energy position
with the marker on the screen.
The and keys are used to set the energy value.
Pressing the button again and holding it cancel this mode.

When a CPR is performed, a metronome with the rate of 100 compressions a
minute and a compression counter are activated.
5.7.2 AED procedure
Make sure that the patient is unconscious and has no pulse or breathing.
1 Turn the device on.
When switched to the AED mode, the device checks that the defibrillation
electrodes (reusable or flexible electrodes, the patient's impedance) are connected
correctly. Should any non-conformity be found, the device will be in standby mode,
with the voice and visual messages generated.
2 Expose the patient's chest and apply disposable flexible electrodes according to
the instructions on the electrode package.
3 Follow the voice instructions and messages on the screen:
- if a rhythm requiring defibrillation is detected, the device will automatically start
gaining energy and the "DISCHARGE IS RECOMMENDED. DO NOT TOUCH THE
PATIENT" prompt will appear.
After the energy is gained, the device prompts to press the "DISCHARGE"
button. The energy is retained for 30 s. If the "DISCHARGE" button is not
69
pressed during this period or the shockable rhythm has disappeared ("THE
SHOCKABLE RHYTHM HAS DISAPPEARED"), the energy is discharged to the
internal load.
To deliver the discharge, press the "DISCHARGE" button, and the

discharge counter on the screen will be updated. After the discharge, the ECG analysis
stops, and the device switches to the CPR mode with the metronome and compression
counter features. After 2 minutes (200 compressions) of the CPR, the rhythm analysis
resumes;
- if no shockable rhythm can be found, the "No Shockable Rhythm" message
appears, and the device prompts to start CPR (2 minutes).
After the CPR is completed, the rhythm analysis resumes. Notes:
1 A movement artefact can delay the analysis or affect the ECG signal, leading to
an inappropriate discharge or missing message to deliver a discharge. Make sure that
the patient does not move during the ECG analysis.
2 To deliver the discharge, press the "DISCHARGE" button. The device does not
make discharge automatically.
CAUTION!
For safety reasons, some low-amplitude or low-rate heart rhythms, as well as
some ventricular tachycardia, may not be interpreted as suitable for defibrillation.
6 OPERATION PROCEDURE
6.1 ECG Path Operation Procedure
6.1.1 There are two ways to take an ECG:
- through the defibrillation electrodes;
- through the ECG cable (4 or 10 leads).
CAUTION!
Do not use the ECG cable made by other manufacturers.
The cable has defibrillation protection.
70
WARNING!
Make sure that the electrodes do not touch any current-conducting materials,
particularly, at the time of connecting/disconnecting the electrodes to/from the patient.
To take a patient's ECG with the ECG cable, connect the cable to the ECG
connector of the device (Figure 26 b) and connect disposable ECG electrodes supplied
together with the device to the cable (Figure 26 c).
CAUTION! The disposable electrodes are not intended to be re-used. Re-use
affects the measurement accuracy and could cause contamination and spread of
infections.
The general view of a four-lead ECG cable is shown in Figure 26 a.
a) b)
c)
Figure 26
71
The arrangement of the ECG electrodes on the patient's body is determined by the
method of obtaining ECG leads. The recommended arrangement of the electrodes is
shown in Figure 27 (the black (neutral) electrode is not involved in the lead formation
and may be applied in any place considered suitable).
Red Black
Yellow
Green
Figure 27
When using a ten-lead patient cable, the same connector on the side panel of the
device shall be used as when using the four-lead ECG cable. The ECG limb electrodes
(4 pcs) and the chest electrodes (6 pcs) shall be connected to the patient cable. In this
case, the ECG electrodes shall be arranged as shown below (Figure 28):
72
Figure 28
Initial settings of the ECG channel (* - values stored in the memory):

- sensitivity (*), mm/mV;
- scanning rate (*), mm/s;
- the filters (band-elimination (50 Hz) and anti-tremor (T)) are turned on;
- the HR alarm is disabled;
- HR sound (*).
To switch between the leads, press the "I, II, ..." on-screen menu button, after
which a relevant message appears on the screen.
In the MONITOR mode, VR..VF, V1...V6 leads are additionally displayed.
To switch the sensitivity between 10 mm/mV, 20 mm/mV, and 5 mm/mV, press
the "Settings - ECG - mm/mV" on-screen menu buttons (stored in the memory). To
switch the scanning rate between 25 mm/s, 50 mm/s, and 12.5 mm/s, press the "Settings
- ECG - mm/s" on-screen menu buttons (stored in the memory).
73
If required, the ECG scanning can be stopped; to do so, press the "Pause" on-
screen menu button ("Pause" lettering in the middle portion of the screen). Pressing the
"Pause" button again will resume the scanning.
To turn the anti-tremor filter on and off, press the "Settings - ECG - Filter" on-
screen menu buttons. Herewith, a letter T appears or disappears on the screen.
During the ECG monitoring, the device counts and indicates the HR. Each
detected R wave is accompanied by a symbol on the screen and a sound signal.
To enable and disable the HR sound, press the button.

Herewith, a symbol X appears and disappears on the screen. To set volume of the
HR sound (four levels: 1-2-3-4), press the "Settings - Volume*" buttons.
6.1.2 Setting the alarm limits
To change the limits, press the "Settings - Alarms" on-screen menu buttons. An
image as shown in Figure 29 will appear on the screen. The pointer highlights the upper
HR limit. To select the limit to be set, press the "Select" button. To set the limit, press
the or button to increase or decrease the value, respectively, with the

increment of 5 beats/minute.
When the device is de-energized, the set limits are stored in the RAM.
74
Figure 29
6.1.3 Setting the date and current time
Press the "Settings - Screen - Date" buttons in succession. Use the and
buttons to place the pointer next to the first number of the date. Use the and
buttons to change the number. Repeat, moving the pointer to all numbers of the date
and current time until you reach seconds (they are not subject to adjustment).
According to the standard time signal, press "Start"; the seconds will be reset to
zero, and the clock will start.
75
6.1.4 Changing the screen brightness
To change the image brightness, press the "Settings - Screen - " buttons in
succession. The button is used to set five brightness levels: 1-2-3-4-5.
6.1.5 To switch the device to display messages on the screen and print with a
thermal printer in English, press the "Settings - Screen" buttons in succession, then press
and hold the "Screen" button.
Repeat to return the device to the Russian language. When the device is de-
energized, the selected language is stored in the RAM.
6.1.6 Displaying the rhythmograms and scattergrams (only in the MONITOR
mode)
Press the "Settings - ECG - Graph" buttons in succession.
An image as shown in Figure 30 will appear in the bottom line of the screen.
Save Rhythm Scatt. Reset Exit
Figure 30
Press the relevant button to select the required mode.

A rhythmogram is a display of a complete set of the RR intervals: Y-coordinates
equal to the relevant values of the RR intervals are successively marked with vertical
segments along the X-axis with a uniform spacing.
A scattergram (a correlative rhythmogram according to E. A. Bereznoy) is a two-
dimensional display of a cardiointervalogramm.
76
To plot a scattergram, points with coordinates (х, у) defined by the following
series shall be plotted in succession on the X, Y plane:
(RR1, RR2); (RR2, RR3); ... ; (RRi ,RRi+1); ... ; (RRN-1, RRN), where RRi is the value of
the I-th RR interval; N is the number of the RR intervals in the set under study.
You can print the graphs with a thermal printer.
To delete and resume a rhythmogram (scattergram), press the "Reset" button.
To exit the mode, press the "Exit" button.
6.2 Recorder Operation Procedure
6.2.1 The paper feed rate of the recorder is 12.5, 25, 50 mm/s.
Thermal paper with or without a grid, 57-58 mm wide, in rolls with the diameter
of no more than 50 mm shall be used for the recorder.
6.2.2 Papering
Turn the device on and open the recorder panel (Figure 31 a). Put the paper roll
into the tray and feed the paper tape to the roller, with the heat-sensitive layer down
(Figure 31 b). The recorder will automatically take and feed the paper (Figure 31 c).
Close the panel.
77
a) b)
c)
Figure 31
78
6.2.3 Setting the paper type
It is recommended to use gridded paper. This provides lower power consumption
from the battery.
If thermal paper without a grid is used, the recorder can automatically grid itself.
To switch to this mode, press the "Settings - Screen - Printer - Grid" on-screen
menu buttons in succession, and the device with switch to the grid printing mode.
Pressing the "Grid" button again deactivates the mode.
When the device is de-energized, the selected mode is stored in the RAM.
6.2.4 Starting and Stopping the Recorder
Use the button to turn the recorder on.
To stop the recorder, press the button again. If the button is not pressed again, it
will stop automatically after 20 s of operation.
The recorder can automatically start in two cases: upon defibrillation and upon
generation of an alarm when the parameters (HR, PR, SPO2) go beyond the pre-set
limits.
When the recorder starts automatically, the information of 4 s before the start and
5 s after the start is printed out on the paper tape, and the recorder automatically stops.
79
6.2.5 Setting the paper feed rate
Press the "Settings - ECG - mm/s" buttons in succession and set the rate to 12.5,
25, or 50 mm/s (corresponds to the screen scanning rate).
6.3 Using the Device in the MONITOR Mode
Press the "MONITOR" button to switch the device into the MONITOR
mode.
An image as shown in Figure 32 will appear on the screen. The pulse sound is
generated based on the HR or, if there is no HR, the PR.
Figure 80
80
6.3.1 Pulse oximetry channel operation procedure
Pulse oximetry is a noninvasive method of continuous measurement of arterial
oxygen saturation (SpO2). The resultant SpO2 is a percentage of oxygenated
haemoglobin molecules from the total number of molecules in arterial blood.
The pulseoxymetry sensor transilluminates the patient's tissue towards its
receiving end. Red and infrared LED light passes through peripheral body parts, such
as a finger (Figure 33).
LED
Photodetector
Figure 33
A photodetector located on the opposite side from the LEDs compares the light
absorption values before and after the pulsation. The amount of the transmitted light
represents the level of blood flow in small arteries. The measured light absorption
during the pulsations is converted into a percentage of arterial oxygen saturation, and
the SpO2 value is displayed on the screen.
81
The general view of the pulseoxymetry sensor is shown in Figure 82.
Figure 34
Connect the pulseoxymetry sensor to the SpO2 connector of the device
(Figure 35). The "NO SрO2 SENSOR" message on the screen will be replaced with the
"NO PATIENT" one.
Figure 35
82
CAUTION!
Do not use SpO2 sensors made by other manufacturers.
Put the pulseoxymetry sensor on the index finger of the patient. The "NO
PATIENT" message on the screen will be replaced with the "SETTING" message and
then PPG and measured PR and SрO2 values will be displayed.
If the measured parameters are to be recorded, follow the instructions in 6.2.4.
To set the PR and SрO2 alarm limits and enable the alarm, follow the instructions
in 6.1.2.
The pulse oximeter determines the SрO2 value (arterial oxygen saturation) using
the optical measurement methods. With this method, tissues and vessels are
transilluminated by light with various wavelength, and the measurement result might
be affected by
- direct exposure to sunlight;
- intense ambient light (operating lamps);
- IR source;
- UV source;
- contaminated measurement point or sensor;
- opacity or change of colour in the measurement point (nail polish).
Due to a number of affecting factors, the SрO2 measurement cannot be used as an
exclusive method of monitoring of a vital function. Other parameters (ECG, pressure,
breathing) shall be constantly monitored as well.
WARNING!
Do not rely only on SpO2 readings; monitor the patient's condition at all times. An
inaccurate measurement result may be due to
- incorrect setting or use of the sensor;
- significant levels of dysfunctional haemoglobin (e. g., carboxyhaemoglobin or
methaemoglobin);
- introduced dyes, such as methylene blue, or intravascular dyshaemoglobins, such
as methaemoglobin and carboxyhaemoglobin;
83
- powerful external light sources, such as surgical lamps (especially those fitted
with xenon sources), bilirubin, fluorescent, IR lamps or direct sunlight.
6.3.2 NIBP channel operation procedure

Non-invasive blood pressure is measured with the use of a cuff as shown in
Figure 36.
Connect the tube tip of the adult or paediatric cuff to the CUFF sleeve of the
device, according to the selected operation mode (Figure 37). For operation in the
paediatric mode, press the "Settings - Screen - NIBP - Paediatric" buttons in succession.
Press the "Paediatric" button again to switch to the adult mode.
Figure 36
Figure 37
84
To measure the ABP, apply the cuff to the left or right hand of the patient
(Figure 38) and press the "Start" on-screen menu button.
Figure 38
The compressor shall start operating. During the inflation and decompression, the
current pressure is displayed in the ABP area. The compressor sets the cuff pressure to
180 mm Hg for the first measurement and to the value exceeding the measured systolic
pressure by 30 to 40 mm Hg for the subsequent measurements. When changing the
patient, press and hold the "Start" on-screen menu button to return to the first
measurement mode; herewith, the "NEW PATIENT" message will appear. Upon the
measurement, the pressure is released and the values of systolic, diastolic, and mean
blood pressure are displayed. The measured ABP values can be recorded according to
the procedure in 6.2.4. Pressing the "Start" on-screen menu button again at any time
will shut the compressor down; herewith, the measurement will be stopped, and the
pressure will be released.
If the measurement is not completed, the following message will be displayed:
- "No inflation", which indicates a leak in the pneumatic system or faulty pressure
sensor of the device (the device needs repair);
- "Low signal" or "No pulse found", which indicates weak pulsation, incorrectly
applied or loose cuff;
- "Decompression error", which means that the pressure release rate is not
supported (the device needs repair or a pinched hose);
85
- "Artefacts", which indicates a lot of artefacts during the measurement. The
patient shall not move during the measurements. It is possible that the demanding data
filter is disabled.
In this case, press the "Settings - Screen - NIBP - Filter" on-screen menu buttons
in succession and repeat the measurement (pressing the "Filter" button again deactivates
it).
- "Too high systolic ABP", which means that the mainline pressure is insufficient
to measure the systolic pressure. In this case, the automatic re-inflation and repeated
measurement are performed;
- "Emergency release", which means that the pressure in the pneumatic system is
over 300 (150*) mm Hg.
- "Exceeding 180 sec", which means that the pneumatic system is under pressure
of over 15 (5*) mm Hg for over 180 (90*) s;
- "Not responding NIBP unit", which indicates failure of communication with the
NIBP unit.
Note. The values with an asterisk (*) are specified for the paediatric mode.
WARNING!
Do not carry out noninvasive blood pressure measurements on patients with sickle
cell disease or if the patient's skin is or may be damaged.
Because of the risk of hematoma on the cuffed limb, the decision of whether or
not to perform automatic blood pressure measurements on patients with severe blood-
clotting disorder should be based on the clinical state assessment.
Do not apply the cuff to a limb with an inserted catheter or an IV line connected.
Doing so may cause damage to the tissue around the catheter by slowing or blocking
the infusion while the cuff is pressurized with air.
Use only tested cuffs and tubing to avoid inaccurate data, wounds and injuries. All
listed cuffs are protected against the defibrillator discharge effects.
Extended series of non-invasive blood pressure measurements may cause purpura,
ischemia and neuropathy of the cuffed limb.
86
When monitoring the patient, check the color, temperature and sensitivity of the
limb regularly. If any abnormality occurs, stop all blood pressure measurements
immediately.
The patient's position, physiologic condition, and other factors may affect the
blood pressure measurements.
To obtain accurate blood pressure readings, the cuff shall be of the proper size and
correctly placed on the patient's limb.
Incorrect cuff size or position may result in incorrect readings.
6.4 Pacing Channel Operation Procedure
Press "CARDIAC PACING" button The screen will display an image as

shown in Figure 39.
Figure 39
87
The channel operation mode will be set automatically when the corresponding
pacing cable is connected to the pacing connector (mode indication in the right middle
field of the screen).
The indications for cardiac pacing are:
1 Bradycardia
2 Tachycardia control
3 Prophylactic fitting
According to experts, the most accessible and safe methods are:
- external (transthoracic) cardiac pacing (ECP);
- endocardial cardiac pacing (ENDO);
- intra-esophageal cardiac pacing (IECP).
CAUTION!
Endocardial and intra-esophageal pacing shall only be carried out in medical
treatment facilities by professional medical personnel who have studied the pacing
techniques.
6.4.1 External (transthoracic) cardiac pacing (ECP) - pacemaker electrodes are

applied to the chest. It is applicable in emergencies as an intermediate step prior to
temporary or permanent endocardial pacing. It is also used as a prophylactic measure
in case of probable arrhythmogenic complications during manipulations in patients.
Since high-amplitude (up to 200 mA) and long (20-40 ms) pulses are used, the
procedure is accompanied by severe pain sensations, therefore, deep sedation and
analgesia is required if the patient's consciousness is preserved.
External pacing (ECP) procedure:
1 The patient lies on the back. Special adhesive electrodes are used for ECP. The
first electrode is placed on the left side of the chest, near the cardiac apex. The second
electrode is placed on the back, opposite to the first electrode or in the right
infraclavicular region;
2 Set up monitoring: ECG, non-invasive blood pressure, SpO2;
88
3 Switch the defibrillator to the pacing function and connect the electrodes. Set
the initial pacing rate to 80 ppm.
If circulatory arrest occurs, start pacing with the highest possible current. In other
cases, increase the current gradually until the pulses are captured by ventricles. Signs
of pulse capture: widening of the QRS complex and appearance of a wide T-wave on
the ECG, palpation of the arteries pulse of the appropriate frequency.
4 Conscious patients shall be sedated.
5 Determine further management of the patient. Where necessary, start preparation
for transvenous endocardial electrode fitting to continue cardiac pacing.
6.4.2 Endocardial cardiac pacing (ENDO) - pacemaker electrode is guided into

the cardiac cavity. It is the most versatile and effective method, though it requires time
and trained personnel to perform. When realizing this method, complications may occur
such as pneumothorax, cardiac perforation, infection, bleeding, thrombosis, etc.
ENDO allows the rhythm to be imposed over a longer period of time, causing less
discomfort to the patient.
Indications:
1 Emergency treatment of arrhythmias and heart block.
2 Emergency cardiac pacing.
3 Stabilization of hemodynamic parameters in bradycardia occurring in the acute
myocardial infarction.
4 Resuscitation measures.
5 Transportation of a patient with hemodynamically significant bradycardia.
Contraindications:
1 Paget syndrome: a central venous access is used on the unaffected side.
2 Low blood coagulation after thrombolytic therapy. High-level mastery of central
vein catheterization technique avoids bleeding.
3 Artificial tricuspid valve. Careful manipulations avoid mechanical trauma to the
valve.
4 Cardiac arrest for more than 20 minutes. Low probability of successful
resuscitation.
89
Endocardial cardiac pacing (ENDO) procedure:
A pacing electrode is guided into the heart cavity – usually in the right ventricle –
through a catheter inserted in one of the veins. Usually, the more convenient access is
through the right internal jugular or subclavian vein, where the electrode is easier to
manipulate during insertion, and thrombotic complications are less common (Figure
40). Femoral or peripheral veins are used to a limited extent. Depending on capabilities
of the medical treatment facility, the procedure is performed under visual control:
fluoroscopic, ECG, and rarely ultrasound guidance.
Figure 40
Preparation:
1 Check the equipment and ensure the defibrillator and other resuscitation
equipment are ready;
2 Position the patient as for central venous puncture. Provide venous access by
placing a catheter in a peripheral vein. Position the ECG electrodes so that they do not
interfere with manipulation of the pacing catheter. Connect the monitor (ECG, non-
invasive ABP, SpO2);
90
3 Treat the skin at the puncture site with antiseptic solution and isolate the
electrode insertion site with sterile material;
4 Check that the electrode passes through the catheter or special transducer that
you will insert into the patient. It is preferable that the temporary pacemaker electrode
and the transducer are of the same size. Typically, 5 or 6 French electrodes are used for
ECP in adult patients;
5 Perform central vein catheterization. The electrode is generally considered easier
to manipulate when accessed through the right internal jugular vein, however the access
through the right subclavian vein is less likely to dislodge the electrode with patient
movement. With coagulopathy, it is safer to use the internal jugular or femoral vein for
access.
Complications of endocardial pacing:
- electrode dislodgement;
- infection, thrombophlebitis;
- diaphragmatic stimulation;
- perforation of the right atrial or right ventricular wall.
CAUTION!
Endocardial pacing shall be performed with continuous ECG monitoring and a
defibrillator available!
Do not apply force when guiding the electrode to avoid myocardial perforation
and trauma to the central vein wall!
Observe sterility while performing the endocardial pacing!
91
6.4.3 Intra-esophageal cardiac pacing (IECP) - pacing electrode is placed in the
esophagus at the level of the left atrium. It is very rarely possible (~5% of cases) to
impose ventricular stimulation from the esophagus, which means the method will have
no effect with A-V blocks. Concerning the emergency care, the intra-esophageal cardiac
pacing has relatively limited indications: relief of type I atrial flutter, supra-ventricular
tachycardia involving AV node.
The IECP method is only effective in arrhythmias caused by the reentry
mechanism: intra-nodal, orthodromic and antidromic, atrial paroxysmal tachycardia,
type I atrial flutter.
Type II atrial flutter, atrial fibrillation and ectopic atrial tachycardia cannot be
eliminated by the IECP. Due to the low probability of success and severe pain in the
patient, do not attempt to use the intra-esophageal cardiac pacing in bradyarrhythmias:
complete atrioventricular block, second-degree atrioventricular block, sinus arrest.
The IECP is performed under outpatient treatment in the department of functional
diagnostics. The duration of the study is about 30 minutes, and the results are analyzed
by a functionalist at the end of the manipulation.
Examination procedure:
1 The patient shall be put on a couch without a pillow. In some cases, a local
anesthesia of the root of tongue and the posterior pharynx is carried out using lidocaine
or dicaine solution. However, anesthesia is most often not used because of the risk of
an allergic reaction to these drugs.
2 Usually, a sterile electrode is inserted into the patient's esophagus (Figure 41)
through the nose and nasopharynx, and less commonly through the mouth. The patient
is asked to make swallowing movements while inserting the electrode. The probe used
for IECP is thin, and in most cases it can be easily inserted. Electrodes are attached to
the chest to record an electrocardiogram.
92
Figure 41
3 The probe is inserted to a depth of about 40 cm to a point where the heart is

closest to the esophagus. After the electrode is inserted, a cardiogram is recorded and
then weak electrical pulses are delivered to the heart through the electrode to increase
its contraction rate. The patient may feel slight discomfort, retrosternal burning or
tingling. This is a normal reaction.
4 The physician observes the patient's electrocardiogram and concludes about the
condition of the cardiac conduction system and the presence of arrhythmias. During the
examination, rapid heartbeat episodes may be provoked, but they are fully controlled
by the physician and stopped immediately, where necessary.
5 At the end of examination, the electrode is retracted from the esophagus, and the
patient usually waits for the physician's report and goes to a cardiologist.
Indications for IECP:

- heart pounding attacks that are not recorded during 24-hour ECG monitoring;
- slow pulse events, followed by heart pounding attacks;
- continuous slow pulse;
- fainting fits and dizziness, especially in young people;
93
- WPW syndrome;
- study of various characteristics of paroxysmal supraventricular arrhythmia for
diagnosed patients;
- efficacy evaluation of antiarrhythmic treatment, including surgical;
- in some cases, diagnostics of coronary heart disease.
Contraindications:
- the patient's refusal or intense neurotic reaction to the electrode introduction;
- esophageal diseases (tumours, esophagostenosis, esophagitis in the acute stage,
esophageal polyps);
- acute conditions, including those accompanied by fever;
- difficulty of nasal breathing;
- atrial fibrillation at the time of the test;
- type II and III atrioventricular heart block (diagnosed using ECG);
- an intracardial clot (detected using heart ultrasound).
6.4.4 Initial settings when connecting the ECP cable (menu buttons are specified
in parentheses):
- Fixed ("Mode") — fixed stimulation mode;
- 70 pulses/minute ("Pulse/min") — pulse frequency;
- 20 ms (T, ms) — pulse duration;
- 40 mA — current amplitude selected with buttons ,

Pressing the "Mode" button will switch to the Overdrive mode. The initial
frequency setting is 200 pulses/min. The Overdrive mode differs from the Fixed mode
by a wider range of pulse frequency setting (up to 250 pulses/min for ECP and up to
900 pulses/min for IECP and ENDO).
94
To select the Demand mode, press the "Mode" button. The HR limits are displayed
in the upper middle section of the screen. In contrast to the modes above, in this mode,
the pulses are delivered to the patient after the patient's ECG is analyzed and the HR
parameters exceed the specified range.
This mode setting requires: - to receive ECG on the display screen via the
electrocardiographic cable according to the instructions of 6.1.1; - to set the required
HR limits according to the instructions of 6.1.2; - to set the Demand mode and the
required parameters of ECP pulses on the device.
Press the ON button. The message "HR ANALYSIS STIMULATOR" will appear
on the display screen.
Where the heart rate goes beyond the set limits, the "STIMULATOR ON"
message will appear on the display screen. In this case, a sequence of eight pulses (with
the preset parameters) is transmitted to the patient, whereafter the device will switch
again to the ECG analysis mode. If HR returns beyond the set values in the course of
analysis, the stimulator will send a sequence of pulses again until the HR is within the
set limits.
6.4.5 Initial settings when connecting the IECP or ENDO cable:
- Fixed ("Mode") — permanent stimulation mode;
- 70 pulses/minute ("Pulse/min") — pulse frequency;
- 10 ms (T,ms) — pulse duration for IECP (1 ms for ENDO);
- 10 mA — current amplitude.
In all modes, pressing the corresponding buttons will change the parameters,
where necessary (the "Mode" button is locked when the stimulator is on).
Press the ON button to turn on the pacemaker (ECP pulses delivery to the patient),
and the "STIMULATOR OFF" message will change to the "STIMULATOR ON"
message. Press the ON button again to turn off the stimulator (cancel the ECS pulses
delivery to the patient).
CAUTION! With the ECP cable connected, the defibrillator's energy gain and
discharge are blocked.
The cardiac pacing process can be interrupted at any time by pressing the OFF
button, and the "STIMULATOR OFF" message will appear on the display.
95
During the stimulation process, the presence of electrode contact ("NO
CONTACT" message) and functionality of the current supply circuits ("CURRENT
PROTECTION" message) are monitored.
6.4.6 The intensity of pacing is set using the buttons . The intensity of
cardiac pacing can be changed during stimulation as well.

The cardiac pacing degree depends on the patient's constitution. The selected
amperage should make the effects of pacing visible on the ECG. If the effects of cardiac
pacing are clearly visible on the ECG, the "maximum comfortable" intensity can be
determined by carefully reducing the intensity.
The "Mode" button is locked during pacing.
96
7 MAINTENANCE
7.1 Maintenance shall be carried out by medical personnel of a treatment and

preventive care facility.
7.2 The following activities shall be included in maintenance scope:
- use a clean, dry, lint-free soft cloth to wipe the outer surface of the device, power
cord, insulating parts of handles, electrodes and electrode cables, as well as the front
panel and the inner surface of the cover with electrode compartments at least once a
week;
- wipe the contact surfaces of the electrodes with a cloth wetted with 3% hydrogen
peroxide solution with 0.5% detergent solution or 1% chloramine solution after each
use;
- wipe the SpO2 sensor once with 70%
alcohol or 1:10 Sodium Hyoicho (diluted bleach) after each patient;
- check the cables and electrode handles for possible defects. Cables or electrodes
shall be replaced if cracks or chips are found on their plastic parts;
- plug the device in, set the energy to 50 J and press the "CHARGE" button. After
the energy is automatically reset, repeat the procedure twice more at energies of 50 and
200 J. Repeat the operation on a monthly basis;
- charge the battery (1.4.5) at least once every 6 months if the device is not used
for its intended purpose.
7.3 The service life of the replaceable battery is 3 to 5 years.
If the battery fails, it must be replaced. After replacement, the battery must be
trained according to the following procedure:
- charge the battery according to procedure as specified in 1.4.5;
- gain the energy of 100 J and discharge it to the built-in artificial load. After 1 to
1.5 minutes, repeat the 100 J energy gain and discharge. Perform 30 cycles of that kind;
- gain the energy of 200 J and discharge it to the built-in artificial load. After 1 to
1.5 minutes, repeat the 'gain-discharge' cycle until the battery is completely discharged;
- charge the battery according to procedure as specified in 1.4.5.
CAUTION!
97
1 Do not use various solvents (acetone, benzene) for maintenance.
2 Mechanical damage to the electrodes is strictly prohibited when working with
the electrodes.
3 Cleaning with the device turned on is not allowed.
4 Any faults down to the fuses and battery replacement should only be repaired in
specialized medical equipment repair facilities, and before the expiration of the
warranty period - at the manufacturer's plant.
7.4 SpO2 and NIBP channels should be checked at least once a year.
7.4.1 Pulseoxymetry channel monitoring Check the SpO2 scale range in
accordance with Figure 42.
Put the pulseoxymetry sensor on the optical finger of the simulator so that the
sensor LEDs are at the bottom of the optical finger.
Set the SpO2 monitoring mode on the defibrillator.
Successively change the SpO2 values from 0 to 100% according to the simulator's
Operation Manual and check the SpO2 readings on the defibrillator screen.
Use the defibrillator screen to check whether the SpO2 alarm limit can be set from
75% to 99%.
Check the range and absolute error when measuring modulation depth ratio of two
signals and in subsequent calculation of SpO2 according to Figure 42.
Set the SpO2 value to "95%" on the simulator.
Take SpO2 readings on the defibrillator screen once they are set.
Re-check with the SpO2 values of "85%" and "75%" set on the simulator.
Calculate the absolute error at each controlled point as the difference between the
readings of the monitor screen and the SpO2 values set at the simulator.
The absolute error shall be within the limits specified in 1.3.17.
Check the pulse rate measurement range and automatic start of the recorder in
accordance with Figure 42. Successively set the pulse rate values of 45, 120, 240 bpm
on the simulator and check the steady-state values of the pulse rate on the defibrillator
screen.
98
The pulse rate values shall be within the limits of 42-48 bpm, 117-123 bpm, and
237-243 bpm, respectively.
On the defibrillator, set the pulse rate upper limit to 230 bpm, activate the PR
alarm, and check that the recorder starts automatically.
Defibrillator to
be tested
SрO2 Simulator Pulseoxymetry sensor
Index 2XL
Figure 42
7.4.2 NIBP channel monitoring.

Check the pressure measurement range and absolute error of measurements in the
ABP channel (1.1.26a) in accordance with Figure 43.
For the ABP channel, set the PRESSURE GAUGE mode on the device.
Use the blower to set the pressure (while monitoring it on the device screen) to
290 mmHg. Slowly reduce the pressure using the blower valve down to 280 mmHg and
read the voltmeter. Recalculate the voltmeter reading in mmHg and determine the
absolute error of the ABP channel as the difference between the reading indicated on
the device screen and the pressure value determined by the IPDC digital pressure
measuring complex.
Recheck at a pressure of 230; 180; 120; 70; 40 mmHg. The initial pressure set by
the blower shall be exceed the pressure in the checkpoints by at least 10 mmHg.
Check the average rate of pressure drop in the pneumatic carrier in the measuring
and maximal pressure protection mode according to Figure 43.
Press the "START" button on the device, and after the compressor stops running,
manually pump up with the blower while monitoring the pressure on the screen. When
the pressure reaches 250 mmHg, start the stopwatch. When the pressure reaches 50
99
mmHg, switch off the stopwatch and calculate the average pressure drop rate using the
formula (2):
Vav= (P1-P2)/t (2)
where
P1 – pressure at the moment of the stopwatch start (250 mmHg);
P2 – pressure at the moment the stopwatch deactivation (50 mmHg);
t – time measured by the stopwatch, s.
Press the "START" button. After completing the compressor operation, slowly
increase pressure with the blower and verify that at (300-330) mmHg pressure is
released with an audible alarm and "EMERGENCY RESET" message on the screen.
Check the maximum time during which the pneumatic system is under pressure
exceeding 15 mmHg in accordance with Figure 43.
For the ABP channel, set the PRESSURE GAUGE mode on the device.
Use the blower to set pressure to 80-100 mmHg and start the stopwatch. After 180
seconds as maximum, a pressure release should occur accompanied by an audible alarm
and the "EXCEEDING 180 SEC" message on the screen .
100
T-
Defibrillator to connector
be tested
ABP
T-connector
А1 — IPDC digital pressure measuring complex series 89010;

Е1 — Receiver with volume of 500±25 cm3;
Е2 — Air blower with the pressure-relief valve and shutdown valve;
Р1 — Universal digital voltmeter В7-34А
Figure 43
101
8 TYPICAL FAULTS AND TROUBLESHOOTING
8.1 When using the device, failures may occur. Refer to Table 5 for the list of
possible failures and troubleshooting recommendations.
8.2 For minor repairs, the manufacturer will send a set of design documentation
to the repair facility under a separate contract.
CAUTION!
The defibrillator is a device of increased danger for the operator and the patient,
since it contains high voltage components and high energy storage containers. Thus,
the device should be repaired only in specialized medical equipment enterprises or at
the manufacturing plant.
102
Table 5
Failure description Potential cause Troubleshooting
recommendations
1 The device does not turn on when The battery is low. Charge the battery
operating in the battery mode (the according to 1.4.5.
display screen does not light up).
2 When gaining energy, the device The battery is low, time Charge the battery -
goes to the ALARM mode. to gain energy is according to 1.4.5. In
increased. case of repeated switch to
the ALARM mode, the
device is subject to
repair.
3 No battery charge The charger or the The device shall be -
battery pack is repaired
defective.
4 Power-on test error The watch battery is Replace the battery
RTC...ERROR low. This occurs at the CR14250BL-AX.
(It does not affect the instrument first power-on after the Set the date and time.
operation; date and time are not battery replacement
valid)
103
9 STORAGE AND TRANSPORTATION
9.1 Storage
The device shall be stored in heated (cooled) and ventilated premises under the
following conditions:
- ambient temperature from plus 5˚С to plus 40˚С;
- relative humidity shall not exceed 80 % at +25°C and lower. At higher
temperatures, the air humidity should be lower than specified above;
- storage facilities should be free from dust, acid and alkali fumes, and corrosive
gases.
Store the device in its carrying case or in the consumer packaging to protect it
from damage.
The battery should be charged at least once every 6 months during storage period.
9.2 Transportation
The device shall be transported in any transport package by covered vehicle at
ambient temperature from minus 50˚С to plus 50˚С.
Operational transportation should be performed in a carrying case within the
temperature range from 0 ˚С to plus 40 ˚С. When in use, the device is recommended to
handle in a carrying case and protect against shocks and impacts.
After transportation at a temperature below minus 10°С, the device shall be used
not earlier than after 4 hours of being in premises with a temperature of plus 10°С to
plus 35°С.
104
10 ACCEPTANCE CERTIFICATE
Defibrillator - Monitor DKI-N-11 "AXION"

as per TU 9444-162-07530936-2008
serial number_____________________
complies with Technical Specifications TU 9444-162-07530936-2008 and has
been deemed fit for operation.
Date of manufacture_____________________
L.S.
Representative of QCD _____________________
Signature_____________________
105
11 MANUFACTURER'S WARRANTY
The manufacturer guarantees that the defibrillator complies with the
specifications, provided that the customer observes the operation, transportation, and
storage conditions.
The warranty period shall be 24 months from the date of manufacture.
The warranty storage period shall be 6 months from the date of acceptance by the
QCD.
Repair during the warranty period shall be performed by the manufacturer.
The warranty shall be void if the device is ripped open, if there are mechanical
damages resulted from improper operation, or when the Operation Manual is not
available.
If the failure is not the result of non-compliance with the operation, transportation
and storage conditions, the device together with its Operation Manual shall be returned
to the manufacturer with an indication of the nature of the failure.
The package shall protect the device from mechanical damage, dust and moist
during transportation. Packaging should exclude the possibility of moving the device
inside it.
Shipping, repair or replacement of the device during the warranty period shall be
made at the expense of the manufacturer.
106
For repairs, consultations, spare parts purchasing, and in case of any information
about non-conforming events with the characteristics of an adverse event (incident),
please contact the After-Sales and Shipping Office by phone/fax:
(3412)51-12-97,
E-mail: bgomt271@mail.ru
Medical Equipment Sales Department of Axion Concern Ltd.:

tel.: (3412) 72-39-27;
fax: (3412) 72-43-29, (3412) 72-39-53;
E-mail: med@c.axion.ru
Details on the nearest authorized Axion service centre can be found at the website:
www.axion-med.ru.
107
12 DISPOSAL DETAILS
12.1 The device does not contain or emit toxic substances, heavy metals, or their
compounds to the environment during its operation or storage. At the end of its service
life, the device must be transferred to organizations engaged in disposal in accordance
with the requirements of SanPiN 2.1.3684-21 Sanitary and Epidemiological -
Requirements for the Maintenance of the Territories of Urban and Rural Settlements,
for Water Bodies, Drinking Water and Drinking Water Supply, Atmospheric Air, Soils,
Residential Premises, Operation of Industrial and Public Premises, Organization and
Conduct of Sanitary and Anti-Epidemic (Preventive) Measures (Section X), and the
state regulations on the disposal of medical products applicable at the time of disposal.
108
13 DECLARATION OF ELECTROMAGNETIC COMPATIBILITY
LEVELS
Manufacturer's guidelines and declaration: Emission

Defibrillator Monitor DKI-N-11 is intended for use in the electromagnetic environment
described below. The customer or user of the Defibrillator Monitor DKI-N-11 must ensure
that the equipment is used in this environment.
Emission test Conformity Guidelines for the electromagnetic environment
Radiofrequency emission Group 1 The Defibrillator Monitor DKI-N-11 uses the
as per CISPR 11 RF energy for its internal functions only. The RF
interference emission is low and unlikely to
cause malfunction of the nearby electronic
equipment.
Radiofrequency emission The Defibrillator Monitor DKI-N-11 is suitable
Class A
as per CISPR 11 for use in all locations except for the residential
Harmonic current as per premises and buildings directly connected to the
Class A
IEC 61000-3-2 electrical distribution network supplying the
Voltage fluctuation and residential buildings.
rapid voltage change as Conforming
per IEC 61000-3-3
109
Manufacturer's guidelines and declaration: interference immunity
that the equipment is used in this environment
Interference Test level as per IEC Compliance with the Guidelines for the
immunity test 60601 interference immunity electromagnetic
requirements environment
Electrostatic - ±8 kV at contact ±2, 4, ±8 kV at contact ±2, 4, Floors must be wooden,
discharge as per 8, 15 kV through air 8, 15 kV through air concrete or tiled. If
IEC 61000-4-2 floors are covered with a
synthetic material, the
relative air humidity
should be at least 30%.
Electrical fast ±2 kV for power supply ±2 kV for power Power quality of the
transient/burst as lines ±1 kV for I/O supply lines ±1 kV for building mains shall
per IEC 61000-4- lines I/O lines comply with standard
4 conditions of
commercial or hospital
environment
Microsecond - ±0.5; 1 kV for ±0.5; 1 kV for Power quality of the
high-energy interference with wire- interference with wire- building mains shall
impulsive noise as to-wire circuit ±±0.5; 1; to-wire circuit ±±0.5; comply with standard
per IEC 61000-4- 2 kV for interference 1; 2 kV for conditions of
5 with wire-to-ground interference with wire- commercial or hospital
circuit to-ground circuit environment
110
Dynamic changes 100 % UH (voltage dip) 100 % UH (voltage dip) Power quality of the
of power supply within 0.5 period (phase within 0.5 period (phase building mains shall
voltage as per IEC shift 0˚, 45˚, 90˚, 135˚, shift 0˚, 45˚, 90˚, 135˚, comply with
61000-4-11 180˚, 225˚, 270˚, 315˚) 180˚, 225˚, 270˚, 315˚) standard conditions
of commercial or
100 % UH (voltage dip) 100 % UH (voltage dip) hospital
within 1 period (phase within 1 period (phase environment. If the
shift 0˚) shift 0˚) user of Defibrillator-
Monitor DKI-N-11
30 % UH (voltage dip) 30 % UH (voltage dip) needs continuous
within 25 periods (phase within 25 periods (phase operation under -
shift 0˚) shift 0˚) conditions of
potential supply -
voltage
100 % UH (voltage dip) 100 % UH (voltage dip)
interruptions,
within 5 s within 5 s
Defibrillator-
Monitor DKI-N-11
is recommended to
power from a battery
or uninterrupted
power supply unit
Power frequency 3 A/m 30 A/m Characteristics of the
magnetic field as 10 minutes power-frequency
per IEC 61000-4- 50-60 Hz magnetic field
8 should match the
standard conditions
of commercial or
hospital
environment.
Note. UH is the AC mains voltage prior to application of the test level.
111
Manufacturer's guidelines and declaration: interference immunity
that the equipment is used in this environment.
Interference Test level as per Compliance with the Guidelines for the
immunity test IEC 60601 interference immunity electromagnetic
requirements environment
Conducted 3 V (root-mean- 3 V (root-mean-square The distance from means
disturbances induced square value) in value) of mobile radiotelephone
by radio-frequency the band of communications to any
electromagnetic 0.15 MHz to 80 6 V (root-mean-square part of the Defibrillator
fields as per IEC MHz value) Monitor DKI-N-11,
61000-4-6 including cables, should
6 V (root-mean- not be less than the
square value) in recommended separation
the ISM band of distance calculated in the
0.15 MHz to 80 following equation for the
MHz transmitter frequency.
where P is the maximum

output power in Watts
(W) determined by the
manufacturer, and d is the
recommended separation
distance in meters (m).
112
Radio-frequency 3 V/m, 3 V/m
electromagnetic field 80 MHz to
as per IEC 61000-4-3 2.5 GHz
(80 MHz to 800 MHz)
(800 MHz to 2.7 GHz)

For radio-wave
propagation from
stationary radio
transmitters, the field
strength determined
during the
electromagnetic
surveillance, should be
less than the conformity
level in each frequency
band. Interference may
occur near equipment
marked with the symbol
Note:
1 - at frequencies from 80 to 800 MHz, a higher frequency range is used.
2 - expressions are applicable not in all cases. Electromagnetic wave propagation is affected
by absorption or reflection from structures, objects, and people.
113
а
ISM frequency bands (for industrial, scientific and medical devices) in the range from 150
kHz to 80 MHz are as follows: 6.765-6.795 MHz; 13.553-13.567 MHz; 26.957-27.283 MHz;
40.66-40.70 MHz.
c
For radio-wave propagation from stationary transmitters, such as base stations of radio
telephone networks (cellular/cordless) and ground-based mobile radio stations, amateur radio
stations, broadcast transmitters in the AM and FM bands, and television transmitters, the field
strength cannot be calculated with adequate accuracy. This requires practical measurements
of the field strength. If the values measured at the installation site of the Defibrillator Monitor
DKI-N-11 exceed the applicable conformity levels, it is necessary to supervise the
Defibrillator Monitor DKI-N-11 operation to make sure that the device is functioning
properly. Where unstable operation is detected during supervision, additional measures may
be required (for example, redirection or relocation of the Defibrillator Monitor DKI-N-11).
d
In the frequency ranges from 150 kHz to 80 MHz outside the ISM band, the signal levels
should not exceed 3 V/m.
114
14 LIST OF APPLICABLE STANDARDS
Standard designation Standard description

Unified system of corrosion and ageing protection.
GOST 9.014-78 Temporary corrosion protection of products. General
requirements.
Aluminium foil for technical purposes.
GOST 618-2014
Specifications.
GOST 10354-82 Polyethylene film. Specifications.
GOST 14192-96 Marking of cargoes.
GOST 14254-2015 Degrees of protection provided by enclosures (IP
Code).
Machines, instruments and other industrial products.
Modifications for different climatic regions.
GOST 15150-69 Categories, operating, storage and transportation
conditions as to environment climatic aspects
influence.
GOST 18251-87 Gummed tape on paper substrate. Specifications.
Medical electrical equipment. Part 2. Particular
GOST 30324.30-2002 requirements for the safety of automatic cycling
indirect blood pressure monitoring equipment
Medical products. Classification in accordance with
GOST 31508-2012
potential risk of using. General requirements.
Medical electrical equipment. Part 1. General safety
GOST R 50267.0-92
requirements
Medical instruments, apparatus and equipment.
GOST R 50444-2020
General technical requirements.
GOST R ISO 15223-1-2023 Medical devices. Symbols to be used with information
to be supplied by the manufacturer. Part 1. General
requirements
115
Standard designation Standard description
GOST R IEC 60601-1-2022 Medical electrical equipment. Part 1. General
requirements for basic safety and essential
performance.
Medical electrical equipment. Part 1-2. General
requirements for basic safety and essential
GOST R IEC 60601-1-2-2014
performance. Collateral standard. Electromagnetic
compatibility. Requirements and tests
Medical electrical equipment. Part 1-8. General
requirements for safety. General requirements, tests
GOST IEC 60601-1-8-2022
and guidance for alarm systems in medical electrical
equipment and medical electrical systems.
Medical electrical equipment. Part 2-4. Particular
GOST R IEC 60601-2-4-2013 requirements for the basic safety and essential
performance of cardiac defibrillators.
GOST IEC 62304-2022 Medical devices. Software. Life cycle processes.
MU-287-113 Recommended practice for disinfection, pre-
sterilization cleaning and sterilization of medical
products.
Sanitary and epidemiological requirements for the -
maintenance of the territories of urban and rural -
settlements, for water bodies, drinking water and -
SanPiN 2.1.3684-21 drinking water supply, atmospheric air, soils,
residential premises, operation of industrial and
public premises, organization and conduct of sanitary
and anti-epidemic (preventive) measures
116

UM DKI-N-11 (EN, 2024)

Uploaded by

Copyright:

Available Formats

UM DKI-N-11 (EN, 2024)

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

UM DKI-N-11 (EN, 2024)

Uploaded by

Copyright:

Available Formats

DEFIBRILLATOR MONITOR

Defibrillator Monitor DKI- - product name

- Eurasian Conformity mark

12.0 to 16.8 V 9.8 A - DC voltage (12.0 to 16.8) V, 9.8 A DC (input);

- type BF, the input is protected from defibrillation

- subject to disposal according to applicable regulations

- dangerous electrical voltage (high voltage)

IP44 - degree of protection against foreign bodies and water ingress

SW version 0.0.7 - software version

- best before (usage end date)

- temperature limit (operating temperature)

Contraindications for use:

1.3 Technical Parameters

1.3.3 The maximum energy at the load of 50 Ohm is (360±54) J.

1.3.21 AED mode

1.3.26 The software version is at least 0.0.7.

1.4 Design and Principle of Operation

Figure 2 – Structure scheme of defibrillator

1 - device on/off button;

Figure 3 – General view of the device and its controls

1.4.3.2 Desktop computer operation procedure

- three bars (green) mean 75 % of the battery charge;

- two bars (yellow) mean 50 % of the battery charge;

- one bar (red) means 25 % of the battery charge;

the interval of approximately 2 s.

The device must not be used in an explosive atmosphere, in the presence of

The device cannot be used in water or in the rain.

The device may only be used in the configuration provided by the

The device modification is not allowed!

4.2 Screen Views

4.4 Turning the Device On and Off

indicator and the indicator on the front panel light up.

The general view of the power cable is shown in Figure 11.

Figure 13 – Functions of the on-screen menu buttons in the DEFIBRILLATOR mode

The initial settings of the defibrillator when turned on are

To set the required energy level, press the (decrease) or (increase)

the button (confirmed by a voice message).

the "CHARGE" and the "DISCHARGE" buttons, respectively.

Pressing any of the , , or "CANCEL" buttons clears the

electrode or the front panel.

When the "CHARGE" button in the middle portion of the screen is

5.3 Applying the Defibrillation Electrodes

(Figure 18) or the "DISCHARGE" button on the front panel.

discharged to the internal load; to do so, press the "CANCEL" button.

an output energy indicator on the front panel.

To check the device performance, place the electrodes in the transportation

5.7 Automatic External Defibrillation

"DEFIBRILLATOR AUTO/MANUAL" button.

Pressing the button again and holding it cancel this mode.

button. The energy is retained for 30 s. If the "DISCHARGE" button is not

To deliver the discharge, press the "DISCHARGE" button, and the

Initial settings of the ECG channel (* - values stored in the memory):

detected R wave is accompanied by a symbol on the screen and a sound signal.

To enable and disable the HR sound, press the button.

the or button to increase or decrease the value, respectively, with the

Press the relevant button to select the required mode.

6.2 Recorder Operation Procedure

Use the button to turn the recorder on.

6.3 Using the Device in the MONITOR Mode

6.3.2 NIBP channel operation procedure