0% found this document useful (0 votes)
13 views24 pages

ST Ezo-01-Tourniquet-Control-Unit 30.0025.000 en 500B

Uploaded by

Darijo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
13 views24 pages

ST Ezo-01-Tourniquet-Control-Unit 30.0025.000 en 500B

Uploaded by

Darijo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 24

ST/500B

SINGLE ELECTRONIC
TOURNIQUET CONTROL UNIT
EZO-01 TYPE
Cat. No. 30.0025.000

www.chm.eu
EN

All comments should be addressed to

ChM sp. z o.o. Lewickie 3b,16-061 Juchnowiec K., Poland


tel. +48 85 86 86 100, fax: +48 85 86 86 101
www.chm.eu e-mail: [email protected]

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

6. USE OF EZO-01 CONTROL UNIT DURING THE PROCEDURE 12


7. GRAPHIC AND SOUND MESSAGES 13
8. ELECTROMAGNETIC COMPATIBILITY 14
8.1. ELECTROMAGNETIC EMISSIONS 14
8.2. ELECTROMAGNETIC IMMUNITY 14
8.3. SEPARATION DISTANCES 15

9. CLEANING AND DISINFECTION 16


10. STORAGE 16
11. WARRANTY AND SERVICE 17
12. THE LIFETIME AND DISPOSAL 17
13. LABELS AND WARNINGS 18
14. TROUBLESHOOTING19
EN

Read the Instructions for Use prior to the first use.

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.

2. SPECIFICATIONS AND EQUIPMENT


Power supply 230 V ± 10 %, 50 Hz ± 2 %
Battery life 90min
Power consumption 60W
Work factor Compressed air (compressed by built-in compressor)
Output pressure (in tourniquet) 100÷550mmHg with 5mmHg increments
Setting range of time 1÷99min. with 1min. increments
Dimensions (H/W/D) 20.5cm x 21cm x 22.5cm
Weight 4kg
Ingress Protection Rating IP20, EN 60529

The manufacturer reserves the right to structural changes.

Equipment supplied with the device.


name Pcs

Power cord AC 230V, 5m 1

Tourniquet control unit air hose - blue


1
cat. No. 30.0035.010

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


4 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

3. ACCESSORIES

EZO-01 unit should only be used with original accessories provided by ChM sp. z o.o.

3.1. TOURNIQUETS

The range of use


No Product name Dimensions Cat. No
(limb circumference in cm)
1 Single arm tourniquet 25÷40 64x13 30.0009
2 Single tourniquet for children 14÷20 50x6 30.0010
3 Single femoral tourniquet 38÷58 85x14 30.0012
4 Single femoral tourniquet 38÷58 120x13.5 30.0013
5 Single femoral tourniquet 38÷58 140x13.5 30.0008
6 Conical single femoral tourniquet 40÷60 110x11 30.0014
7 Single arm tourniquet long 38÷58 82x8 30.0015
8 Single arm tourniquet 25÷40 62x7 30.0016
9 Single tourniquet for babies 10÷17 30x3 30.0017

3.2. MOBILE STAND FOR TOURNIQUET CONTROL UNITS


[30.0040.000]
The stand is used as a mobile platform for the tourniquet control unit, as
well as the accessories needed to be used with the device, such as tour-
niquets, skin protection padding, power cords and other accessories.

Technical parameters

Dimensions (H/W/D) 900 x 570 x 570 mm

The height with the control unit 1100 mm

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.

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
5
EN

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

4.1. CONTROL PANEL

5
10

1 6

2 7

3 8

4
9

1. ENTER button 5. STAND BY button 9. Tourniquet connec-


2. PRESSURE button 6. MENU button tion port
3. TIMER button 7. INFLATE button 10. LCD Display.
4. Control knob 8. DEFLATE button

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


6 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

Control panel elements

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).

Pressing the control knob equals pressing the ENTER button.

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.

TOURNIQUET CONNECTION PORT


9
Place where the ChM tourniquet is connected to the EZO-01 control unit.

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
7
EN

4.2. THE DISPLAY MAIN WINDOW


The main window is displayed when the control unit is turned on and when the control unit cooperates with
the tourniquet.

4
1

2 5

6
3

1. The value of the pressure in the tourniquet


2. The value of the time of occlusion
3. Counting down / Counting up
4. The control unit in edit mode of tourniquet pressure
5. The control unit in edit mode of occlusion time
6. Mains power / Battery power (with information on the battery charge level)

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


8 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

5. USAGE

5.1. EZO-01 CONTROL UNIT ACTIVATION


Use AC power cord (supplied with the device) to connect the EZO-01 to 230V/50Hz network with a protective
grounding. Turn the switch located on the back panel of the device ON. Press the STAND BY button located
on the control panel. The internal auto-test will be activated. Afterwards, the main window will be displayed.

If the internal auto-test result is negative, an error message


will appear on the screen.

Further work with the device will not be possible.


Contact the device manufacturer.

Connect the tourniquet (using a spiral hose supplied with the control unit) to the slot located on the control panel.

5.2. USE OF THE DEVICE WHEN BATTERY POWERED


In the case of: power failure, when the control unit is not plugged in or the switch on the back panel is OFF,
the EZO-01 automatically switches into battery power mode. The battery power icon ,will be displayed as
well as information on the battery charge level (tab. 1).
Icon Battery charge level
Operating time of the EZO-01 on battery power is dependent
on many factors. When the battery charge level goes below 30%, 100÷70%
initiate battery charging by connecting the control unit to AC
70÷50%
230V power network (the display shows the mains power icon ).
50÷30%
5.3. OCCLUSION PRESSURE
Push the PRESSURE button. The display will show the value 30÷10%
of the required pressure and the icon indicating that the unit
10÷0%
is in pressure edit mode. By turning control knob, set the desired
pressure (in the range from 100 to 550 mmHg). Confirm the selected Tab.1. Battery charge level
value pressing ENTER button or control knob. If the pressure se-
lection is performed before inflating the tourniquet, once approved, the displayed value returns to the value
of 000 (the actual pressure in the tourniquet). If the pressure is edited after inflating the tourniquet, pressure ap-
proval automatically changes the pressure in the tourniquet to the selected one.

5.4. OCCLUSION TIME


Push the TIMER button. The display will show the value of the required time and the icon indicating that
the unit is in time edit mode. By turning control knob, set the desired time [in the range from 1 to 99 min]. Con-
firm the selected value pressing ENTER button or control knob. Time edit mode is completed. The time can be
changed both, before and after inflating the tourniquet.
The clock is activated automatically when the tourniquet is being inflated. When the selected time has been
reached, a beep sound will be emitted. If the tourniquet is not deflated or new time is not set, the timer will
start to count up from the 00.

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
9
EN

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.

5.5. TOURNIQUET INFLATION


Press and hold pressed for minimum 2s INFLATE button. The control unit will start to fill in the tourniquet, what
will be shown on the display as an increasing pressure level up to the selected one. Automatically, the occlu-
sion time measurement will be activated.

Inflating loose, not applied on a limb or rolled into a tight roll tourniquet can cause its damage.

5.6. TOURNIQUET DEFLATING


Press and hold pressed for minimum 2s DEFLATE button. The control unit will start to empty the tourniquet,
what will be shown on the display as an decreasing pressure level down to 000 value. Automatically, the oc-
clusion time measurement will be stopped.

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).

Fig. 2. The menu window

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


10 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

ICON DESCRIPTION WINDOW VIEW

Timer settings.
Two options:
• Count down (from the specified value down to zero);
• Count up (from zero up to specified value)

Settings of the system clock.


Two options:
• Show (show the date and time settings)
• Settings (set the date and time)

Language options.
Three possible options:
• Polish
• English
• Russian

Display settings.
Six levels of brightness.

Speaker. Key Tone.


Two options:
• ON
• OFF
No option to mute the alarm.

Information concerning general EZO-01 parameters:


• Last pressure value
• Last time value
• Speaker (on/off )
• Battery level

Autotest.
Defining the efficiency of the unit control - tourniquet system.
See p. 5.7.1 of these instructions.

Data Transfer Mode.


Repairs can only be performed by qualified service personnel.

Tab. 2. Description of available options of the menu window

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
11
EN

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

6. USE OF EZO-01 CONTROL UNIT DURING THE PROCEDURE

Prior to use, read p. 5 USAGE of these instructions.

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.

Prior to each use:


• perform a visual inspection of the product,
• verify the basic functioning of the unit control (inflating, deflating, etc.),
• verify the battery charge (use control unit only with fully charged battery),
• perform the testing in accordance with section 5.7.1 of these instructions,
• prepare a replacement unit.

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

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


12 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

after inflating the tourniquet.


When the occlusion time is reached, a beep sound will be emitted. If the tourniquet is not deflated or new time
is not set, the timer will start to count from the 00.

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.

7. GRAPHIC AND SOUND MESSAGES


EZO-01 single tourniquet control unit is equipped with a range of graphic and sound messages that inform
the user about relevant parameters or irregularities during the operation. The table (Tab. 3.) lists the causes
of the messages, types of messages and the actions to be taken.

Cause Message Action

- begin the process of charging the battery,


- graphic information
Low battery level connect the control unit to AC 230V 50Hz network,
- sound signal
switch on the rear panel must be in ON position

- verify the tightness of cords, tourniquets


and all connections between the tourniquet
Leakage in control unit - - graphic information and the control unit. Remove the leakage.
tourniquet system. - sound signal If the leakage cannot be removed, depending
on its place, replace the tourniquet or the control
unit.

- action depends on a surgeon’s decision (deflating


Occlusion time limit reached - sound signal
the tourniquet, continuation of occlusion)

Tab. 3.

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
13
EN

8. ELECTROMAGNETIC COMPATIBILITY

8.1. ELECTROMAGNETIC EMISSIONS


Emission test Compliance Electromagnetic environment – guidance
The device uses RF energy only for its internal
RF emissions, function. Therefore, its RF emission is very low
Group 1, Class B
CISPR 11 and it is not likely to cause any interference
in nearby electronic equipment.
The device is suitable for use in all establishments,
including domestic establishments and those
Harmonic emissions
Class A directly connected to the public low-voltage
IEC 61000-3-2
power supply network that supplies buildings used
for domestic purposes.
Voltage fluctuations /
flicker emissions, Comply
IEC 61000-3-3

8.2. ELECTROMAGNETIC IMMUNITY


Immunity test IEC 60601-1-2
Compliance level Electromagnetic environment – guidance
standard test level
Electrostatic ±6kV contact ±6kV contact Floors should be made from wood, concrete
discharge (ESD) ±8kV air ±8kV air or ceramic tile. If floors are covered with a synthetic
IEC 61000-4-2 material, the relative humidity should be at least 30%.
Electrical fast ±2kV for power ±2kV for power Mains power quality should be that of a typical
transient / burst supply lines supply lines commercial or hospital environment.
IEC 61000-4-4 ±1kV for in/ out lines
Surge ±1kV line to line ±1kV line to line Mains power quality should be that of a typical
IEC 61000-4-5 ±2kV line to earth ±2kV line to earth commercial or hospital environment.
Voltage dips, <5% Ut (0.5 cycle) <5% Ut (0.5 cycle) Mains power quality should be that of a typical
short interruptions commercial or hospital environment.
and voltage variations 40% Ut (5 cycles) 40% Ut (5 cycles)
on power supply lines If the user of the device requires its continuous use
IEC 61000-4-11 70% Ut (25 cycles) 70% Ut (25 cycles) even during power outages, it is recommended
that the device be connected to an emergency
<5% Ut (5 seconds) <5% Ut (5 seconds) power supply.

Ut - mains supply voltage


Power frequency 3A/m 3A/m Power frequency magnetic fields should be at levels
(50/60 Hz) characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
IEC 61000-4-8

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


14 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

Immunity test IEC 60601-1-2


Compliance level Electromagnetic environment – guidance
standard test level
Conducted RF 3 Vrms V1 = 3V/m Portable and mobile RF communications equipment
IEC 61000-4-6 150 kHz to 800 MHz should be used no closer to any part of the device,
including cables, than the recommended separation
Radiated RF 3 V/m E1 = 3V/m distance calculated from the equation applicable
IEC 61000-4-3 80 kHz to 2500 MHz to the frequency of the transmitter.
Recommended separation distance
d = 1.17 √P
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and d is
the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a),
should be less than the compliance level in each
frequency range b).
Interference may occur in the vicinity of equipment
marked with the following symbol:

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.

8.3. SEPARATION DISTANCES


For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Rated maximum output Separation distance according to frequency of transmitter [m]


power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W) d = 1.17 √P[m] d = 1.17 √P[m] d = 2.33 √P[m]
0.01 0.12 0.04 0.1
0.1 0.37 0.11 0.32
1 1.2 0.35 1.0
10 3.7 1.1 3.2
100 12 3.5 10

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
15
EN

9. CLEANING AND DISINFECTION

Before cleaning or disinfection, disconnect the device from 230V network!

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.

The EZO-01 control unit should NOT be sterilized

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%.

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


16 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

11. WARRANTY AND SERVICE


When servicing, warranty and post-warranty repairing is concerned, please contact the manufacturer’s repre-
sentative or contact ChM directly
ChM sp. z o.o.
Lewickie 3b
16-061 Juchnowiec Kościelny, POLAND
tel: +48 85 86 86 100
fax: +48 85 86 86 101
e-mail: [email protected]
www.chm.eu

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.

12. THE LIFETIME AND DISPOSAL


The ChM sp. z o.o. does not define the maximum number of uses for the EZO-01 control unit. The useful life
of the device depends on many factors including the method and duration of each use, applied cleaning and dis-
infection and the handling between uses. Nontheless, the lifetime of the EZO-01 control unit is assumed for 10
years. After this period, the product should be sent to the manufacturer in order to: determine the device fur-
ther suitability for use, perform maintenance works, repairs or to recommend the user to purchase a new unit.
The device should be disposed of in accordance with the applicable electrical and electronic equipment law.
It is recommended that the battery be replaced at least once a year.

Worn-out lithium-ion battery must be disposed of in accordance with the current law on waste
electrical and electronic equipment.

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
17
EN

13. LABELS AND WARNINGS


Electronic single tourniquet control unit

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

Fig. 3. Data plate

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.

Fig. 4. Warnings marked on the casing.

SYMBOL CONCEPT, MEANING EXPLANATION

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.

Class II The product with double or reinforced insulation.

BF Type of Application The degree of protection against electric shock.

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.

Tab. 4. Explanation of the symbols on the date plate

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


18 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

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.

Problem Possible causes Solution

Leave to dry
The device driver wet due to improper
clearing
Send to ChM service

System error Send to ChM service


System failure Send to ChM service
Accidental or unintended Incomplete information provided
Report to the manufacturer
operations of the device in the safety instructions
Overheating of the device Send to ChM service
Turn off all electrical equipment not in use;
Change the location of electrical equipment;
Strong electromagnetic interference
Plug in electrical equipment to other
available outlets
Exceeding the declared lifetime of the device Send to ChM service for checking the further
(10 years) usefulness of the product
System failure Send to ChM service
No response of the device
System hand up Turn the device off and then back on
to the set parameters
Overheating of the device Send to ChM service
The air hose may be bent or incorrectly
Check the hose and the connection
connected
Damaged tourniquet Replace the tourniquet for a new one
Tourniquet does not inflate
Send to ChM service
Damaged pneumatic air hose
Replace the air hose
System failure Send to ChM service
The air hose may be bent or incorrectly
Check the hose and the connection
connected
Tourniquet does not Damaged tourniquet Replace the tourniquet for a new one
deflate Send to ChM service
Damaged pneumatic circuit
Replace the air hose
System failure Send to ChM service
System failure Send to ChM service
Display damage Send to ChM service
Battery damage Send to ChM service
Dropping of the device Appearance of dangerous voltage
Send to ChM service
on the device housing
Damage to the power cord Replace the power cord for the new one
Damage to the air hose Replace the air hose for the new one

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
19
EN

Problem Possible causes Solution


Unit not plugged in and battery fully
Plug in the unit
depleted
The unit is plugged in but the switch is OFF
Turn the switch ON
Unit does not turn ON. and battery is fully depleted
Damaged power cord Replace the power cord for the new one
Battery failure Send to ChM service
System failure Send to ChM service
The air hose may be bent or incorrectly
Check the hose and the connection
connected
Damaged tourniquet Replace the tourniquet for a new one
The device does not Replace the air hose for the new one
Damaged air hose
maintain the set pressure Send to ChM service
System error Send to ChM service
Exceeding the declared lifetime of the device Send to ChM service for checking the further
(10 years) usefulness of the product
Replace the air hose for the new one
Tourniquet cannot be Damaged air hose
Send to ChM service
connected to the unit
Using tourniquets other than ChM’s Use ChM tourniquets
Use of detergents other than those
Consult the Instructions for Use of the unit
recommended by the manufacturer
Discoloration and scratches
Overheating of the device Send to ChM service
on the surface of the device
Exceeding the declared lifetime of the device Send to ChM service for checking the further
(10 years) usefulness of the product
Charge the battery
Battery fully depleted Replace the battery for the new one
in the manufacture’s service
System error Send to ChM service
Unit switches off System failure Send to ChM service
Turn off all electrical equipment not in use;
Change the location of electrical equipment;
Strong electromagnetic interference
Plug in electrical equipment to other
available outlets
Send to ChM service
End of battery life
Consult the Instructions for Use of the unit
Too short battery life Failure to follow manufacturer’s instructions Consult the Instructions for Use of the unit
Exceeding the declared lifetime of the device Send to ChM service for checking the further
(10 years) usefulness of the product

Information cannot be Display failure Send to ChM service


read from the device System failure Send to ChM service
display System error Send to ChM service

Unit cannot be set Pressure sensed in tourniquet Deflate the tourniquet


to STANDBY System failure Send to ChM service
The air hose may be bent or incorrectly
Check the hose and the connection
connected
Alarm indicating a leaking Damaged tourniquet Replace the tourniquet for a new one
system Send to ChM service
Damaged pneumatic air hose
Replace the air hose for a new one
System failure Send to ChM service

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


20 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
EN

Problem Possible causes Solution


Battery fully depleted Charge the battery
Alarm indicating
Battery failure Send to ChM service
discharged battery
System failure Send to ChM service
The device is not plugged in Plug in the device
No external power supply Damaged power cord Replace the power cord for the new one
icon when the device is The switch is OFF Switch ON
plugged in No mains voltage Check the voltage In the mains
System failure Send to ChM service
The device is not plugged in Plug in the device
The unit is plugged in but the switch is OFF
The battery does not Turn the switch ON
and battery is fully depleted
charge
Battery failure Send to ChM service
System failure Send to ChM service
Possible electrical shock Damage to the power cord Send to ChM service
Turn off all electrical equipment not in use
Change the location of electrical equipment
Electrical interference Occurrence of electrical noise
Plug in electrical equipment to other
available outlets
Staff negligence
The unit has been sterilized Negligence of Instructions for Use supplied Send to ChM service
with the product

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
21
EN

ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec K., POLAND


22 tel. +48 85 86 86 100 fax +48 85 86 86 101 e-mail: [email protected]
ChM sp. z o.o.
Lewickie 3b
16-061 Juchnowiec Kościelny
Poland
tel. +48 85 86 86 100
fax +48 85 86 86 101
[email protected]
www.chm.eu

0197
ISO 9001
ISO 13485

You might also like