Cardioline DELTA 1 Plus User manual

CARDIOLINE®
DELTA 1 Plus
USER MANUAL
ENGLISH VERSION

Number
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4.1
4.2
5.1
5.2
6.1
6.2
6.3
. 6.4
48
M
and
name of chapters
General notices
The electrocardiographic examination
Preparing the patient
Electrode application
Interferences and artefacts
A.C. interference
Muscolar tremor
Base line drift
Unit parts
Control keyboard
Text entry: | version
Liguid crystal display
Base version
| version
Error messages
Base version
| version
Preliminary procedure
A.C. operation
Battery operation
Battery charge
Paper loading
Performing an ECG
Connecting the patient
Operative instructions: base version
Auxiliary programs
Menu: base version
Setup
Charge battery
Autotest
Set heading
Set clock
Index
Page
50
91
51
51
52
52
53
54
55
97
58
59
59
60
62
62
63
64
64
64
64
65
66
66
67
69
70
71
72
73
74
74

Number and
10.
11.
11.1
11.2
11.3
11.4
11.5
12.
12.1
12.2
12.3
13.
12.1
14.
15.
title of chapters
Operative instructions: | version
Menu: | version
System setup
Functions
Test menu
Service setup
СРЛ
The serial & I/O interface
Analogical! signal input
Analogical signal output
Digital communication
Special notices
Use with defibrillator
Specifications
Standard accessories
Page
75
78
80
82
83
84
84
86
86
86
87
41
41
89
90
49

CAUTION: Federal law restricts this device to
sale by or on the order of a physician.
This manual is an integral part of the instrument and describes its normal
use. It should always be kept close to the equipment. Observance of the
manual is a prerequisite for proper instrument performance and correct
operation and ensures patient and operator safety depending on these
factors.
The symbol (1) denotes : observe the operating instructions ! It serves
as an indicator for basically important facts to be noted when operating
the instrument.
According to the prescribed International Regulations (see chapter 14.
Specifications) the equipment described in this manual is not to be used
in presence of an flammable anestetic solution with air or oxygen. The
equipment case io not protected against water infiltration. The equipment
has been developed, according to the conditions of use, for a continuous
operation.
The instrument is not designed for operation in oxygen-enriched
atmospheres and/or in zones of risk where explosion hazards may exist.
The prospective measures of class | are effective only if such instruments
are connected to power outlet sockets with grounding contact. Cables
and plugs which are damaged must be replaces immediately. Extension
cords, in particular those with multiple connectors, should not be used.
Instruments into which liquids have penetrated must be immediately
cleaned and checked by an authorized service technician.
Patient safety, maintenance of the specified measuring accuracy, and
interference-free operation can only be guaranteed when the patient
cables, electrodes, transducers, and probes described in this manual are
used.
For cleaning and disinfection, line power operated instruments must be
separated from the power line.
In the case that the equipment described in this manual could provide
suggestions for interpretation or diagnosis, these suggestions must
always be checked and validated by a specialist physician. Remco Italia
S.p.A. cannot be responsible for the accuracy of the automatic diagnosis
or interpretation given by the unit.
Remco Italia considers itself responsible for the effect on safety,
reliability, and performance of the equipment only if:
+
assembly operations, extensions, readjustments, modifications or
repairs are carried out by Remco Italia or by personnell authorized by
Remco Italia;
。 the electrical installation of the relevant room complies with the
applicable international and local requirements;
* the instrument is used in accordance with the instructions for use.
Further details and information, please contact:
REMCO ITALIA SPA
Strada Rivoltana Nuova 53
S. Pedrino di Vignate (MI)
Tel. [phone] Fax [phone]
50
General notices

1. The electrocardiographic examination
1.1 Preparing the patient
1.2 Electrode application
M
[
This chapter will not deal with clinical or scientific subjects, which are not
within our competence, but it will just give some practical and useful
suggestions to shorten the execution times and make the most of the
technical characteristic of the instruments.
Patient must be lying relaxedly on a comfortable bed that does not force
him/her into unnatural position, likely to cause disturbances such as
“muscular tremors”.
Patient’s chest, legs and forearms must be uncovered ad ail metal objects
such as watches, bracelets and so on, must be removed.
Patient must not be cold, as this too may cause “muscolar tremors”.
All possible contacts with any metallic obiect (i.e. bed frame) must be
avoided, to prevent A.C. interferences.
Skin at electrode application points must be throughly cleaned with
detergent hypo allergic solution.
Reassure the patient as to the harmlessness of the examination.
Most of the disturbances which may influence the ECG trace (base line
stability, A.C. interference, tremors due to poor electrode/skin contacts)
depend on the accuracy of this operation.
Patient’s skin must be, therefore, prepared as carefully as possible, as
mentioned in the previous paragraph : a sufficient quantity of “conductive
gel” should be laid on both the inside surface of the electrode and the
application points.
Rub patient’s skin throughly (particularly if it is thick or dry) so that
conductive gel may be fully absorbed in order to ensure a good electrical
conduction between subcutaneous tissues and electrode.
Limb electrodes must be secured to patient’s legs and arms via the rubber
straps, which should be tightened sufficiently but not excessively, to
prevent electrodes from moving too easily.
As far as precordial (or chest) electrodes are concerned, we recommend
the suction type.
Care must be taken that the patient nor any of the conductive parts
connected with the patient (connectors, electrodes) come in contact with
other conductive parts.
Wash electrodes with water after every application to ensure good
conductivity and long lasting performances.
Avoid the use of alcohol or other liquids as conductors instead of
conductive gel as they tend to evaporate and dry off quickly, originating
unstable ECG traces and/or artifacts .
51

1.3 Disturbances and artifacts
Picture no. 1 shows an electrocardiogram recorded under normal
conditions.
(Picture 1)
The main alterations you may meet with, are the following :
- A.C. interfereces
- muscolar tremor
- base line drift.
1.3.1 A.C. Interference
This disturbance (picture 2) is distinguished by a saw-toothed vibration
of constant width and frequency (typically the A.C. 50-60 Hz frequency)
superimposed on the recording.
{Picture 2)
Causes can be schematically identified as follows :
a) presence of strong eleciro-magnetic fields caused by instruments
operating in the vicinity (i.e. : X-rays, radar therapy, and so on)
b) presence of electro-magnetic fields caused by neon lamps, electrical
transmission lines, etc.
c) poor earth connection
d) power supply cable and patient cable crossing each other
e) breaking of one of patient cable leads. In this case A.C. interference
is of 10 mm or more and it appears exclusively in that part of the trace
regarding the broken lead.
The cause of trouble should be identified and removed quickly; if this
should not be possible, insert the special filter to eliminate ail 50 or 60 Hz
52

1.3.2 Muscolar tremor
In this case (picture 3) an irregular and unsteady saw-toothed line is
superimposed on the electrocardiographic recording.
OVO UN
(Picture 3)
Causes can be schematically identified as follows :
a) restless patient: either cold or uncomfortable, or unwillinglcontracting
muscles
b) pathologies (i.e. Parkinson's disease)
c) poor electrode/skin contact, typically caused by a mechanical friction
of the electrode on the skin.
The phenomenon general'y appears together with shiftings of the
base line.
The cause of troubles should be quickly identified and removed; if this
should not be possible, insert the special low-pass filter to attenuate
muscular tremors. See, for inserting the filter, “Control keyboard”.
53

1.3.3 Base line drift
This disturbance (picture 4) features notable trace shiftings with respect
to paper central line.
|
CARDIOLINE
DELTAL
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(Picture 4)
Causes can be schematically identified as follows :
poor electrode/skin contact (conductive gel, or other)
loose rubber straps
presence of metal particles between electrode and skin
false contact between patient cable and electrode : this normally
appears as violent trace oscillations from one end of the writing space
to the other.
осо
=
+
Q
==
Insert the DRIFT filter to reduce the baseline drift. See for the filter insert
"Menu"
To reset base line position, in Manual mode, press shortly the INST key.
Should disturbances persist even after you have checked and/or removed
the above listed causes, we recommend that you call our authorized after
sale service.
See the chapters about MENU for the filter insertion.
54

2. Unit parts
A.C. inlet
Grounding
Mains ON/OFF switch
Paper housing
Liquid crystal display (LCD)
START/STOP key
Mains operation led
Control keyboard
Interface port RS 232 and auxiliary inputs-outputs (optional)
Input socket for patient cable
Mains and fuses data sticker
1
2
3
4
5
6
7
8
9
1
1 a o
BANGER
WARNING
For continued
fire hazard,
type and rar o:
PLUS

Legenda: ~@» Communication bidirectional connector (Input/Output)
= 2 ON/OFF switch
CV Alternate power supply indicator led
Eguipotentiality
19! Isolation according to safety regulations
Observe the operating instructions !
E
| $ © 0 O) “uke INPUT >
| DATA
K
10 3
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PATIENT CABLE CONNECTION i ON OFF
ELECTRICALLY ISOLATED \ i „E
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—
56

3. Control keyboard
B DIGITAL ECG
FILTER
Press this key to insert, sequentially, the three muscular filters of
increasing strength (MF1, MF2 & MF3); CAUTION: inserting MF2
and MF3 could cause changes in the tracing amplitude and shape.
Press again when reached MF3 to set muscular filters off.
SPEED
Press this key to change paper speed (6.25, 12.5, 25, 50 mm/sec.).
This key is active in the following modes :
a) always while not recording
b) in MANUAL mode even during recording
Please note, in AUTO mode, this key is not active during recording.
SENS
Press this key to change amplitude setting (5 - 10 - 20 mm/mV).
This key ts active in the following modes :
a) always while not recording
b) in MANUAL mode even while recording.
Please note, in AUTO mode, this key is not active during recording.
CALIB
Pressing this key will insert a calibration signal in manual mode
only (1 mV).
INST
Pressing this key in manual mode will speed up centering of the
traces if drift has occurred.
< LEAD
Press this key to change leads, in MANUAL mode, and passing to
the previous lead (or group of leads).
> LEAD
Press this key to change leads, in MANUAL mode, and passing to
the following lead (or group of leads).
FEED
Press this key to skip a page, when using Z-fold paper, or to make
the paper run free until the key is released, when using roll paper.
57

9 - TEXT
Disabled key in the base version of Delta 1 Plus. In the | version
this key allows the Patient Data entry before recording the ECG.
10- MODE
Press this key to select the operating modes AUTO 1, AUTO 2 or
MANUAL and AUTO ARRHYTHMIAS and AUTO CP/I in the |
version.
11- COPY
Pressing this key will print a copy of the stored ECG.
12- FREEZE
Disabled key in the base version of Delta 1 Plus. In the | version
this key is used to freeze and store the ECG in the memory without
recording it on paper, for a late analysis or printout.
13- MENU
With the printer not working, press this key to enter the MENU.
14- START/STOP
Press this key to start recording orto stop it. This same key is active
during MENU displaying as ENTER key.
There is a particular use of the keys in the situations of text entry, only in
the | version of Delta 1 Plus. The START/STOP key in this case gives an
‘Enter command if used alone, while used with the FEED key (which
becomes a Caps Letter key) confirms the present entry and passes to the
following one. For the other 12 keys there are indicated three letters’
each. This means that pressing once, the key wiil give the first letter, twice
the second and the third time the third one. There are some special
characters (such as DEL, SPACE, ', .,,,/,-), forselecting these ones keep
pressed the FEED key and press the desired key.
A little example.
Press TEXT for entering the patient data.
Select, with the >LEAD key to clear the present data.
The unit asks FIRST NAME. For entering EDWARD proceed as follows.
- Press the SPEED key twice, then the START/STOP key;
- Press the SPEED key once, then the START/STOP key;
- Press the TEXT key twice, then the START/STOP key;
- Press the FILTER key once, then the START/STOP key;
- Press the <LEAD key three times, then the START/STOP key;
- Press the SPEED key once, then the START/STOP key;
- Keep pressed the FEED key and press the START/STOP key for
confirming the first name.
The unit asks LAST NAME. For entering SMITH proceed as follows.
- Press the >LEAD key once, then the START/STOP key;
- Press the INST key once, then the START/STOP key;
- Press the SENS key three times, then the START/STOP key;
- Press the >LEAD key twice, then the START/STOP key;
- Press the SENS key twice, then the START/STOP key;
- Keep pressed the FEED key and press the START/STOP key for
confirming the last name.
The unit asks then ID (Identification Code), BIRTH DATE (to be entered
DD/MM/YYYY), AGE, WEIGHT, HEIGHT, SEX (to be selected only with
the START/STOP key).
58
3.1 Text entry: | version

4. Display
4.1 Base version
Besides the usual messages appearing on the liquid crystal display
(LCD), i.e., speed, leads, filters, HR, etc.; the LCD will indicate other
messages which are explained below.
COVER OPEN
PAPER EMPTY
DELTA 1
CONNECTING
PATIENT
OL
VOL
SUPPLY FAILURE
The paper housing coveris not closed properly.
The unit will not operate.
There is no paper in the unit. The unit will not
operate.
The unit is mains operated and it has not been
used for approximately three minutes with the
STANDBY MODE option enabled (see 9.1
Setup); press START/STOP to restart the unit.
This message appears while the patient is
being connected; it will disappear after a few
seconds and the patient's heart rate willappear.
Overload signal; this warning will appear if the
patient cable is not connected or if periphera!
electrodes are disconnected.
V(chest leads)Overload; this warning will
appear if one or more chest electrodes are
disconnected. The ECG tracing will then follow
automatically.
This message indicates that the batteries are
recharging while the unit is operating with AC
line power.
This message appears when the power supply
has been lost during battery recharge (i.e. the
AC cable is disconnected).

4.1 | version
On the Delta 1 Plus | LCD are displayed contemporariy many
informations. For detecting and understanding these informations,
please refer to the following scheme.
1
2
MND STD Cha
[HD 25 10 ---
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A
/
!
へ
1. RECORDING PROGRAMS
In this zone the name of the recording mode is displayed, together
with its characteristics. Also in this zone are displayed the Status
messages of the printer (i.e. PAPER EMPTY, COVER OPEN, etc).
2. MEMORY STATUS
This zone is about the buffer memory status. This information may
be:
- blank space: memory is empty;
- E: an ECG 10 sec. trace is in memory;
- |: together with the ECG trace, also the
Measures and the Interpretation are in
memory.
3. BATTERY STATUS
This zone is about the accumulators status. This information may
be:
- blank space: the unitis working on mains;
- С: the unit is working on mains and is
automatically recharging the accumulators;
the unit is working on batteries, this symbol
shows that the battery is still well charged;
the unit is working on batteries, this symbol
shows that the battery is getting discharged;
the unit is working on batteries, this symbol
shows that the battery is going out of power.
+
E
분
60

4.
ECG TRACE
In this zone the indicated number, with connected patient,
indicates the Heart Rate, the presence of the flashing little heart
shows the detection of ECG signal; the absence of the input signal
is displayed with three lines. The OL message means saturation
on peripheral leads input circuits. The VOL message means
saturation on chest leads input circuits. The message INS means
that the unit is trying to center the trace on paper (selection made
by the user with the INST key, or automatically made at the end of
an OL situation).
AUTORANGE
Here is indicated, with a millivolt symbol, the activation, from
Setup, of the autorange on chest leads.
SENSITIVITY
Here is indicated the selected recording sensitivity.
SPEED
Here is indicated the selected recording speed.
FILTERS
In this zone the codes of the filters in use are displayed.
- H Notch Filter
- D Drift Filter
- MI Muscular Filter 40 Hz
- M2 Muscular Filter 30 Hz
- M3 Muscular Filter 25 Hz

BATTERY CHARGER
BATTERY OUT
OF ORDER
BATTERY LOW
BATTERY
ALREADY FULL
BATTERY
ALREADY CHARGED
This message appears when the battery is
being charged.
This message appears when the battery is
defective; call your Official Cardioline
Service represeniative.
This message appears when the battery is
low. To recharge batteries, see section 9.3.
This message appears when the battery has
reached full charge; it is therefore useless
to leave the unit on to recharge the battery
(tur? unit off).
This message appears when the battery
has already been recharged and has
reached fuil charge; itis therefore useless to
recharge the battery (turn unit off).
The following messages might appear under normal operating conditions
and are designed to aid in the servicing and maintenance of your unit;
when these messages appear, you should simply press START/STOP
and the unit will operate normally.
- CHECKING ROM
- STARTUP ERROR
- PRESS START
If the problem persists, call your Cardioline Service representative.
The following are all malfunction messages:
- INTERNAL ERROR 1
-
INTERNAL ERROR 2
- PRINTER ERROR 1
- BAD TEMPERATURE
- BAD SETUP MEMORY
- DS 1287 DON'T STORE SETUP
If pressing START/STOP does not solve the problem, try turning OFF the
unit for a few seconds. If the problem persists, call your Cardioline Service
representative.
62
5. Error messages
5.1 Base version

5.1 | version
In particular conditions of not perfect functioning, the unit informs the user
with a group of messages, Error or Notice messages. These messages
are composed by a description and a code.
Some of these messages are:
E0009: CLOCK BAD CHECK
E0011...0012: BATTERY DAMAGED
E0020: PARAMS BAD CHECK
E0021: BATTERY OUT
E0022: CPU MALFUNCTION
E0023: PRINTER ALARM 1
E0024: PRINTER ALARM 2
E1500...1599: APPL. ERROR
Press START/STOP and the unit will inform the user, with another
message, if itis possible to continue working. In case the message CALL
ASSISTANCE is displayed, take note of the code and the description of
the error and contact the closest Cardioline Authorised Technical Service
Center.
63

6. Preliminary procedure
6.1 AC operation
Before connecting the unit to AC power, please check that the voltage on
the back plate conforms with your local voltage. If not, contact your
Cardioline dealer immediately and do not attemptto connect the unitto AC
power. If the voltage matches, connect the unit using the AC cable provided
with the unit; the AC cable is a three pin connector with built-in grounding
for stable and correct grounding of the unit; your AC outlet, of course, must
have a grounded socket as described in the international safety regulations
CEI and/or IEC. Use witha non-grounded AC outletis not recomended and
may cause AC interference.
After connecting the unit to AC outlet, press the power switch to turn on
unit (see section 2. Unit parts): the unit will perform a self test. Once
completed the test, Delta 1 Plus is ready to use.
6.2 Battery operations
Turn on the power switch; the unit will perform a self test, once completed,
it is ready for use. With batteries at full charge, the unit will work for two
hours of continuous use without connection with mains.
6.3 Recharging the battery
There are two ways to recharge the battery :
1) Automatic recharge: the battery recharges during norma! operation.
However, we recomend on a monhly basic, recharging the battery
overnight or for eight hours without using it. Simply connect unit to AC
power and turn unit on.
2) Forced recharge: this operation is not necessary under normal
conditions and should be perfomed only when the battery is completely
discharged. For this operation, please refer to section 9.2 or 11.2
(according to the version in your possess).
Note :
Batteries can be charged approximately 500 times without loss in perfor-
mance.
IMPORTANT: (1)
Batteries are considered consommables therefore they are notcoveredby
warranty.
During battery operation the base version of Delta 1 Plus will switch off
automatically after about 3 minutes of non-use; while in the | version it is
possible to select to enable the automatic switch off after 5 or 10 minutes
of non-use, or to disable it (see chapter 11.1 System Setup).
64

6.4 Paper loading
To load the paper please follow these simple instructions :
1) open the paper holder cover until vertical;
2) place the pack of paper in the holder as in fig. 1; make sure that the
black cue mark (the little black square) on the edge of the paper,
is on the bottom side of the paper and that the printed side is not
showing.
3) Slide the paper under the printer roller and push it in, as Straight as
possible, for about an inch (2.5 cm.). The best way to do this is to
push on the paper edges with two fingers, (not in the middle). The
paper should now be completely around the roller.
4) Close the paper cover; the paper will advance to the first black cue
mark.
if the paper does not advance, it has not been pushed far enough around
the roller; repeat steps 3 and 4.
Fig. 1
Fig. 2
If the printed side is not showing, the paper has been inserted upside
down; repeat steps 1 through 4 making sure the paper has been flipped
to the correct side. If the black cue mark is not at the bottom, the unit will
not function properly; repeat steps 1 through 4 making sure the black cue
mark in the correct position.
Note :
for safe and problem-free use of the unit, use only Cardioline paper. Use
of any other paper will render the warranty void.
65