ST Ezo-01-Tourniquet-Control-Unit 30.0025.000 en 500B
ST Ezo-01-Tourniquet-Control-Unit 30.0025.000 en 500B
SINGLE ELECTRONIC
TOURNIQUET CONTROL UNIT
EZO-01 TYPE
Cat. No. 30.0025.000
www.chm.eu
EN
Document No ST/500B
Date of issue 02.06.2013
Review date P-003-20.04.2018
The manufacturer reserves the right to introduce design changes.
CONTENTS EN
1. INDICATIONS 4
2. SPECIFICATIONS AND EQUIPMENT 4
3. ACCESSORIES 5
3.1. TOURNIQUETS 5
OBILE STAND FOR TOURNIQUET CONTROL UNITS [30.0040.000]5
3.2. M
4. CONSTRUCTION 6
4.1. CONTROL PANEL 6
4.2. THE DISPLAY MAIN WINDOW 8
5. USAGE 9
5.1. EZO-01 CONTROL UNIT ACTIVATION 9
5.2. USE OF THE DEVICE WHEN BATTERY POWERED 9
5.3. OCCLUSION PRESSURE 9
5.4. OCCLUSION TIME 9
5.5. TOURNIQUET INFLATION 10
5.6. TOURNIQUET DEFLATING 10
5.7. MENU 10
5.7.1. TESTING 12
1. INDICATIONS
EZO-01 electronic single tourniquet control unit is used to supply compressed air to tourniquets used to control
the blood flow in the extremities in order to produce bloodless surgical field.
The built-in compressor and DC battery allow the functioning of the device without its connection to the com-
pressed air and electrical AC 230V network. Thanks to that, EZO-01 can be used during patient’s transportation,
power supply AC 230V failure and when there is lack of compressed air network in the facility.
DO NOT use the unit in the presence of oxygen, nitrous oxide or a mixture consisting of flam-
mable anesthetics and air.
3. ACCESSORIES
EZO-01 unit should only be used with original accessories provided by ChM sp. z o.o.
3.1. TOURNIQUETS
Technical parameters
Weight 9 kg
Tourniquets and stand are additional accessories of the control unit and are offered as a sepa-
rate accessory. Prior to use, consult Instructions for Use supplied with these products.
4. CONSTRUCTION
1
4
3 5
1. Control panel
2. Handle
3. USB port (for use only by service personnel)
4. ON/OFF AC power switch
5. AC power connection socket
6. Fuse drawer
7. Holes for mounting the control unit on the mobile stand
30.0040.000
5
10
1 6
2 7
3 8
4
9
ENTER
1 It approves changes introduced to: time, pressure, and in the menu
options.
PRESSURE
2
Entry into the pressure settings.
TIMER
3
Entry into the time settings.
CONTROL KNOB
Turn of the control knob:
changes the time and pressure (after entering the pressure or time settings).
4
navigates the menu options (after entering the MENU window).
STAND BY
5
It turns on/off the EZO-01
MENU
6
Entry into the EZO-01 settings window.
INFLATE
7 It activates the process of filling up the tourniquet and the work of EZO-01 control
unit.
DEFLATE
8 It activates the process of emptying the tourniquet and finishes the work of EZO-01
control unit.
4
1
2 5
6
3
5. USAGE
Connect the tourniquet (using a spiral hose supplied with the control unit) to the slot located on the control panel.
The tourniquet does not get deflated when the selected occlusion time is reached.
The occlusion time (after inflating the tourniquet) may be displayed as:
• the increasing value from zero to the set value,the arrow facing up will be displayed
• the decreasing value from the set value to zero, the arrow facing down will be displayed
One of the abovementioned options is selected acc. to p.5.7 of these instructions.
Inflating loose, not applied on a limb or rolled into a tight roll tourniquet can cause its damage.
5.7. MENU
Changes in other parameters of the EZO-01 unit are introduced from the settings window when pressing
the MENU button. For navigation in the settings window and changes introduction, use the control knob. Press
MENU button to leave the (Options) settings window.
Initiation of settings window is not possible during the operation of the control unit with
the tourniquet (after its inflating).
Timer settings.
Two options:
• Count down (from the specified value down to zero);
• Count up (from zero up to specified value)
Language options.
Three possible options:
• Polish
• English
• Russian
Display settings.
Six levels of brightness.
Autotest.
Defining the efficiency of the unit control - tourniquet system.
See p. 5.7.1 of these instructions.
5.7.1. TESTING
For testing, use tourniquet that will be used during the procedure. When replacing the tour-
niquet, the testing should be repeated.
Connect the ChM tourniquet using the spiral air hose supplied with the EZO-01 control unit to the tourniquet
connection port located on the control panel. Roll up the tourniquet tightly and secure against unrolling. Then
enter the Menu and select Autotest. During the testing, the tourniquet will be inflated and the device will check
the tightness of the system: control unit – tourniquet. If the system is tight, the testing will end with a PASS
sign - the control unit and tourniquet can be used during the procedure. Displayed FAILD sign indicates that
the system is not tight. Check the condition of the tourniquet, air hoses, pneumatic connectors and their con-
nection. Eliminate leaks if possible (e.g. replace defective tourniquet or air hose). Run the test again.
Should it be impossible to remove or detect the leaks, it is strictly forbidden to use the set:
control unit-tourniquet for surgery. Only the set with positive test results (PASS displayed) can
be used for surgery
Before using the EZO-01 control unit in surgical procedure for the first time, the device should
be cleaned in accordance with section 9 of this manual.
The EZO-01 control unit can only be used by qualified medical personnel familiar with the op-
eration of the device, such as anesthetists, who control the device outside the operating field.
Should any defect appear, do not use the device until the defect is removed or until the defect
is deemed to have no negative effect on the proper functioning of the device.
Connect the device to the AC 230V network during the procedure. The device functioning on the battery
power during the procedure is allowed only in the case of failure of AC power (for more information about work-
ing on battery power - see p.5.2 of these instructions). Set the occlusion pressure and time. Apply the tourniquet
on the operated limb. Make sure that the pneumatic hose has not been bent. Inflate the tourniquet by pressing
INFLATE button. If it is necessary to regulate the occlusion pressure or time, these changes can be introduced
The tourniquet does not get deflated when the selected occlusion time is reached.
Press and hold for minimum 2 sec. DEFLATE button to empty the tourniquet. After emptying the tourniquet
(the display shows the 000 pressure value), remove the tourniquet from the limb, then disconnect it from the unit
control. The EZO-01 may be switched off by pressing STAND BY button.
The surgeon decides about the: setting values of the control unit (pressure, occlusion time, etc.),
the place the tourniquet is applied, the moment the tourniquet is inflated, deflated and other
parameters.
Tab. 3.
8. ELECTROMAGNETIC COMPATIBILITY
a) F ield strengths from fixed transmitters, such as base stations for radio telephones (cellular/ cordless) and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreti-
cally with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromag-
netic site survey should be considered. If the measured field strength in the location in which the device
is used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the device.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
The outer surfaces of the device should be cleaned with a soft, moistened (not dripping) cloth with a mild de-
tergent solution then wiped dry. In the case of contaminating the housing of the device with infectious agents
(blood, body fluids, etc.), disinfection using disinfectants with a neutral pH is recommended. In such cases, soak
a soft cloth in disinfectant, wipe the housing and allow it to dry.
Do not allow the detergents or disinfectants to enter inside the device housing. Should the de-
tergents or disinfectants enter inside the device housing, switch the device off, disconnect from
230V network and send it to the manufacturer for cleaning processes.
10. STORAGE
The device should be stored in a clean and dry room, off the direct sun, at the temperature of 15 ÷ 30°C and hu-
midity of 20 to 70%.
Do not repair or replace parts of the EZO-01 electronic single tourniquet control unit by your-
self! The changes made will render the warranty void.
he warranty does not include product damage due to:negligence, inappropriate usage, usage not in ac-
T
cordance with the intended purpose, mechanical damage.
Accessories and spare parts are presented in ChM’s catalogues.
Warranty and non-warranty services are to be handled solely by the manufacturer - ChM.
It is recommended to perform technical inspection and calibration of the device at the manu-
facturer’s site at least once every 12 months.
Worn-out lithium-ion battery must be disposed of in accordance with the current law on waste
electrical and electronic equipment.
type EZO-01
Cat. No. 30.0025.000
Serial No. SN:115
ChM Sp. z o.o. power 100÷240VAC 50/60Hz 65W
Lewickie 3b
16-061 Juchnowiec K.
POLAND
www.chm.eu
2015-09
0197
Made in EU
Warnings
Danger!
Risk of electric shock.
Do not remove the cover.
Repairs may be performed by qualified
service personnel only.
Danger! Caution!
Explosion hazard. Use in the safe place
Do not use in the presence and avoid any accidental
of flammable gases. damage.
Caution!
For use by trained
personnel only.
Power input: 230V/50Hz.
Battery only for use
during power outage
or patient's transportation.
It is forbidden to dispose The waste devices and other electronic and electrical products
of the product into unsorted should be collected separately and disposed of in accordance with
municipal waste. the applicable law on waste electrical and electronic equipment.
European conformity mark with Certifies compliance of the unit structure with the guidelines
0197 the number of the notified body of the European Community
Instructions For Use Before the first use, refer to the instructions for use.
14. TROUBLESHOOTING
The following table lists some potential problems that may occur while using the device. For each problem,
the most likely causes are provided.
If any other problems than the ones listed below have occurred or if the suggested actions
have not solved the problem, please contact the manufacturer.
DO NOT perform repairs on your own unless otherwise stated in this manual.
Leave to dry
The device driver wet due to improper
clearing
Send to ChM service
0197
ISO 9001
ISO 13485