Corometrics 115 User manual

COROMETR
115 FETAL MO
OPERATOR'S MANUAL
1

CONTENTS
INTRODUCTION ........................................... 1
SAFETY
................................................... 2
CONTROLS
AND INDICATORS ............................. 5
Front Panel Controls
........................................ 5
Front Panel Connectors ...................................... 7
........................................
Front Panel Displays 7
Tie and Date Set Pushbuttons ............................... 8
........................................
Strip Chart Recorder 9
................................................. Rear Panel 10
Rear Panel Connectors ...................................... 10
OPERATION
............................................... 12
Selecting Monitoring Modes
.................................. 12
Fetal
Heart Rate Monitoring ....................... : ......... 12
.............................................
Uterine Activity 12
Preparing Monitor For Use
.................................. 13
Mounting Strain Gauge ...................................... 14
Chart Paper Installation
..................................... 16
Monitor
Self Test Routines ................................... 18
Application of Monitor
to Patient ............................. 19
FHR Recording . Ultrasound ............................... 19
...................................
F,H R Recording . Phono
22
FHR Rmrding . Internal Direct FECG ...................... 25
Uterine Activity Recording . Tocodynamometer ............... 27
Uterine Activity Recording . Catheter and Strain Gauge ........ 29
Flushing and Calibration of the Strain Gauge ................. 31
Dual Heart Rate Monitoring .................................. 35
......................................
Alphanumeric Messages 38
.....................................
SET TIME AND DATE 40
CARE AND CLEANING .................................... 43
......................................
TROUBLESHOOTING 46
SPECIFICATIONS .......................................... 48
.............................................
ACCESSORIES 50

Features
-
* Quiet, easy-to-load recorder with high-resolution dot
matrix printhead.
Prints out continuous trends and
alphanumeric data on one strip chart in single or dual
heart rate modes.
* Automatic mode selection. The desired monitoring
mode is selected simply by inserting the appropriate
transducer plug into the front panel connector.
* Easy-to-use durable transducer connectors.
* All functions controlled by pushbuttons-including
audio volume, UA reference, time/date set, and paper
advance.
* Cleaner more accurate traces with fewer "dropouts"
using ultrasound or phono because of patented autocor-
relation processing.
* U.S. Patent No. 3,982,528

Section 1
INTRODUCTION
The CorometricsB Model 115 Fetal Monitor is capable of
monitoring two heart rates (maternal and
fetal or twins)
and maternal uterine contractions. Simultaneous trends of
' beat-to-beat heart rate and uterine activity (UA) are plotted
continuously on the built-in
dual channel strip chart
recorder. Fetal heart rate
(FHR) and UA are displayed
continuously on the front-panel numeric display. The
Model
115 is capable of monitoring heart rate and uterine
activity using the following external or internal clinical
methods.
External
Monitoring Modes
1) Continuous-Wave Doppler Ultrasound: A transducer
placed on the abdomen is used to direct
an ultrasonic beam
toward the fetal heart and to sense Doppler-shied echoes
created by moving cardiac structures.
A patented
autocorrelationprocess is used to determine the timing of
successive cardiac cycles.
2) Phono: An acoustically sensitive transducer placed on
the maternal abdomen senses fetal heart -sounds which are
used to compute the fetal heart rate. The patented
autocorrelationprocessing is
also used in the Phono Mode
to improve measurement accuracy.
3) Tocodynamometer: Relative Pressure within the uterus
is measured using a tocotransducer strapped to the
abdomen in the area of the uterine fundus. The readings
are recorded on the strip chart paper
in a relative scale
from
0 to 100.
Internal Monitoring Modes
1) Direct Fetal ECG: FECG waveforms are obtained via a
spiral electrode attached to the fetal presenting part. FHR
is computed on a beat-to-beat basis using the time interval
between R-wave peaks. The instantaneous FHR pattern is
printed on the strip chart paper and the FHR appears on
the numeric display.
2) Intrauterine Catheter and Strain Gauge: Amniotic fluid
pressure is measured using
a transcervical intrauterine
catheter and externally mounted strain gauge. Pressure
trends are plotted over the range of
0 to 100 rnrnHg.
Maternal Monitoring Mode
MECG waveforms are obtained via electrodes placed on
the maternal chest and abdomen. MHR is computed on a
beat-to-beat basis using the time interval between R-wave
peaks. The instantaneous MHR pattern is printed on the
strip chart paper and the MHR appears on the numeric
display.

Section 2
SAFETY
GENERAL USE AND POWER PRECAUTIONS
IMPORTANT: Read this manual before operating the
monitor. Keep this
manual available for future reference
and orientation of new personnel.
Refer to supplementary "Guide to Fetal
Heart Rate
Monitoring" for limitations of internal and external
monitoring techniques.
This monitor is ordinarily shipped with provisions to
operate from a hospital grade three-wire 117-volt electrical
outlet. The monitor
can be changed to operate from other
types of outlets and voltages with appropriate modifications
performed by personnel authorized by Corometrics Medical
Systems, Inc.
Do not defeat the three-wire grounding feature in the
power cord by means of adapters, plug modifications or
other methods.
A dangerous shock hazard to both patient
' and operator may result.
Monitors should be plugged into the same circuit
as other
equipment in use on
the same patient. Your hospital
engineering staff should identify outlets that are on the
same circuit in patient
areas.
This equipment is not designed for use in an explosive
atmosphere, in
the presence of flammable anaesthetics, or
inside an oxygen tent. Use under these conditions may
present an explosion hazard.
LEAKAGE CURRENT
Corometrics monitors are equipped with isolated inputs
(ECG) and isolated transducers (Phono
, ultrasound, strain
gauge, and tocodynamometer). Leakcase current is limited
to a few microamperes even if full power-line vcltage is
applied to the patient leads. However, for maximum patient
safety, the following procedures are recommended.
Keep equipment clean and free of transducer gel, electrode
cream, and other substances.
Do not operate if unit is wet because of spills or
condensation. Condensation could occur
if a monitor is
moved from building to building such as from a cold
environment to a warm and humid location.

DIRECT MEASURING PRECAUTIONS
Because the tip of the spiral electrode is designed to
penetrate the fetal epidermis, the possibility of trauma,
hemorrhage and infection exists.
Direct monitoring should be used only under aseptic
conditions.
Membranes must be ruptured prior to the introduction of
either the spiral electrode or the intrauterine catheter.
When inserting
an intrauterine catheter, do not force the
catheter guide or catheter since it is possible to perforate
the uterus.
Contraindications: The electrode should NOT be applied to
the fetal face, fontanels or genitalia or when it is not
possible to identify the portion of
the fetal body where-
application is contemplated. Direct monitoring should NOT
be used when placenta previa or bleeding from the uterine
cavity
is present; when genital infections (e.g., herpes,
Group
B streptococcus, gonorrhea) or other infections
exist.
-
-

Section 3

Section 3
CONTROLS AND INDICATORS
FRONT PANEL CONTROLS
Volume
Two pushbuttons used to change the volume of sound emitted by the rear-panel speaker. Depressing the button
with the arrow pointing up causes the volume to increase. Depressing
the button with the arrow pointing down
causes the volume to decrease. Volume control has no effect on the processing used to compute heart
rate.
UA Reference
Pushbutton which sets the pressure reference level on the UA recorder channel at 0-mmHg for the strain gauge
or at
10 for the tocodynamometer. To activate, depress and hold for 1 second.
Test
Pushbutton used to initiate a monitor self-test routine. To activate, depress and hold for 1 second.
Mark
,Depressingthe Mark button causes an arrow-shaped mark to be printed on heart rate channel of the strip chart
paper-
Record
Depressing pushbutton activates the recorder, provided paper has been installed. Once the recorder is activated,
- --
* s
depressing Record again turns it off.
An amber light next to the Record pushbutton will be on when the recorder is activated and off when the recorder
is deactivated or if paper has run out. It
will flash when the end of the paper is approaching. When the recorder
is out of paper, the recorder
will automatically stop and cannot be restarted until chart paper is inserted.
Paper Advance
Pressure on pushbutton causes the recorder to advance chart paper at the speed of 25 crnlminute for as long as
the pushbutton is depressed. The recorder will print the monitoring modes, time, date and chart speed informa-
tion
20 seconds after the pushbutton is released, if the recorder is activated.
Power
Pushbutton switch that turns the monitor on and off. A green light next to the Power pushbutton is illuminated
when the Power switch is activated.
Automatic ~aseline 'Zeroing" in External UA Monitoring Mode.
If pressure falls below 0, automatic UA reference wiU occur and new baseline reference is set at 0. The center
margin for the strip chart will automatically
be annotated with "UA REF".

FRONT PANEL DISPLAYS
Heart Rate Display
Heart rate in beats-per-minute will be displayed in the left portion of the window.
Heartbeat Indicator
A heart-shaped symbol flashes with each detected valid heartbeat.
Uterine Activity Display
Uterine activity values displayed in the right portion of the window will represent mmHg for internal uterine ac-
tivity monitoring and relative
units for the external monitoring (Tm).
FRONTPANELCONNECTORS
Ochre colored 12-pin connector mechanically keyed to accept only the Model 115's phono or ultrasound
transducer plugs. The input connector is electrically
keyed to recognize which transducer plug has been inserted.
ECG
Gray colored 12-pin connector which is mechanically and electrically keyed to accept only the ECG transducer
.
plugs.
UA
rg.
White 12-pin connector which is mechaniay keyed to accept either the tocotransducer or strain gauge. The con-
nector is electrically keyed to recognize which transducer plug
has been inserted.

Section 3
TIME AND DATE SET PUSHBUTTONS
Three pushbuttons located under the lip of the front panel. Only active when the rear panel -/DATE SET
switch is in the ENABLE postion. The function of each pushbutton is indicated by a title or an arrow located im-
mediately above the row of pushbuttons.
SELECT T/D
Successive depression of SELECT T/D permits selection of the time or date parameter to be changed.
(Upwards Pointing Arrow)
Activation of the "increase value" pushbutton increases the value of the selected timeldate parameter.
Continuous activation of the pushbutton causes the front panel display to cycle from the lowest value of the
selected parameter to its highest possible value and then to "wrap around" to the lowest value.
(Downwards Pointing Arrow)
Activation of the "decrease value" pushbutton is similar to "increase value" except that decreasing of the
selected parameters occurs.

STRIP CHART RECORDER
The dual-channel strip chart recorder is located on the right side of the front panel. The lever on the left side of
the recorder opens the paper drawer.
Heart Rate Channel
The heart rate channel is located on the left side of the recorder.
Uterine Activity Channel
The uterine activity channel is located on the right side of the recorder.
Alphanumeric Print-Out
When the recorder is activated, time, date, modes of monitoring and paper speed are printed automatically on the
margin between the fetal and uterine activity channels. Various messages relating to functions and parameter
changes wil be printed as the latter occur.
In addition, if the optional 2115 keypad or 2116 keyboard is being
used, messages keyed in by
the operator appear in this margin.

CWWfElCS FETnl UOV~TO~ MOM< 2 7% ZIMSERIES
ccawnalcs UEOI(PL SVSTEY uc
DATA ~mm SYSTEM
ECG ARTIFACT ELlMlNlTlON
@
CHART SPEED ECG
l -8Ddb l
1 CM MlN
3 CM MIN
TIME OATE SET
DISABLE [IID ENABLE
1 50 AMF
CAUTlON A COROLAN
SLOW BLOW FUSE
6 isi
WTIMI ELECTRIC SHOCK HAZARD DO
NOT REMOVE COVER OR BACK REFER SER
ncE ONLY TO QUIUF~ED PERSONNEL
WARNING TO REWCE FIRE HAZARDREPLACE
111111111
FUSES AS MARKED
117 VOLTS
€4 HZ
1CU WATT5
Jt02
CONNECT TOCOROMETRICS
SERIES 400 MONITORS ONLY
REAR PANEL
ECG ARTIFACT ELIMINATION
A two position slide switch is locked in place by means of a plate and two screws. In order to change the switch
position, the plate must
be removed, the switch changed adthe plate reversed to lock it in the new position.
In the ON position, any new HEART RATE value which differs by more than +25 BPM from the previously
calculated heart rate will not be printed.
In the
OFF position, all HEART RATE values will be printed without regard to previous rates. This switch
affects
onl~ the direct ECG mode.
CHART SPEED
Chart paper speed may be set at 1 or 3 cdrnin. (1 or 2 cmlmin.) with this switch.
TIMEIDATE SET
The ENABLE position is used when setting the time and date. The DISABLE position is used at all other times.
REAR PANEL CONNECTORS
ECG (+80dB)
Permits recording of Direct FECG signals on an external recorder. Output level is compatible with standard adult
ECG recorders.
Connector for optional Corometrics
21 15 Keypad or 2116 Keyboard.
b
w
NOTE: Data Entry Keypad should be plugged into J103 connector prior to turning on the monitor's power.

LEG PLATE TESTER
Connector from internal ECG simulator used to test 115 leg plate.
REMOTE MARK
Connector for remote event marker.
HEADSET
Connector for Corometrics headset. Insertion of the headset into this connector will inhibit sounds from speaker.
Connector for use with Corometrics Model
400 Central System Monitors.
GROUND LUG
POTENTIAL EQUALIZATION POINT
Terminal which can be used to provide an additional ground for the monitor.
AC-linecord connector.
MONITOR FUSE HOLDERS
FlOl
Fuseholder for 1.50-ampere SLOW-BLOW fuse.
SPARE
Fuseholder containing spare fuse.
5108 (optional)
COROLAN/RS-232C Input/Output Connector
NOTE: If your Model 115 has an option for connection to a data communications system, the connector for this
option
is located on the rear panel and is labeled (5108). It is also identified by the symbol (A).
Do not attempt to connect a cable to this connector without contacting your Biomedical Engineering Department
or Corornetrics Service. This is to insure the connection complies with leakage-current requirements of one of the
following applicable standards: Underwriters Laboratories U.L.
544, Canadian Standards Association CSA 22.2
No. 125, or International Electrotechnical Commission IEC 601 - 1 .
The maximum nondestructive voltage that may be applied to the rear panel connectors is 0 volts.

Section 4
OPERATION
SELECTING MONITORING MODES UTERIh'E ACTIVITY
The Corometrics Model 115 Fetal Monitor can monitor the Internal Method:
fetal heart rate
in three modes and the uterine activity in
two modes. For maternal heart rate monitoring
see page Intrauterine Pressure Catheter and Strain Gauge
35. A catheter inserted transcervically into the uterine cavity
FETAL HEART
RATE MONITORING transmits intrauterine pressure to the strain gauge. This
pressure is recorded in mrnHg. The membranes must be
Internal Method: ruptured in order to use this method.
Fetal ECG External Method:
This method uses an electrode attached directly to the fetal Tocodynamometer
presenting part and connected to a leg plate on the
maternal thigh. The heart rate is computed based upon the A tocotransducer placed on the maternal abdomen will
- ' interval between successive R-Wave peaks of the fetal record changes in abdominal tension. The resulting tracings
:
ECG. This provides the most accurate FHR patterns. The will reflect uterine contractions.
.$
membranes must be ruptured and the cervix dilated to
t
utilize this technique. Uterine Activity Display
External Methods:
Ultrasound
An ultrasound transducer placed on the maternal abdomen
senses heart motion utilizing the Doppler principle. The
rate is determined using the patented autocorrelation
processing to determine the time interval between
successive heart beats.
Phono
Phonocardiography utilizes a sensitive transducer similar
to a microphone to pick up heart sounds. The patented
autocorrelation processing is used to compute cardiac
intervals. Both the mother and baby need to be relatively
inactive to utilize this method; therefore, this technique is
most useful during the antepartum period or early labor.
Fetal
Heart Rate Displays
The fetal heart rate is displayed in several ways.
A heart
beat indicator (amber backlit heart symbol) flashes for each
detected valid heart beat after the circuits have settled. It
does not flash for event triggers which are rejected by the
monitor's editing.
A three digit amber numeric display
indicates FHR
in beats per minute. This display will be
blanked (except during 3 second warm up and TEST) if no
front panel FHR connector is inserted into the monitor.
FHR trends will be plotted on the fetal channel of the strip
chart. There is
a few seconds delay from printing until the
tracing appears on the moving chart paper. The rear panel
speaker will emit an audible tone for each detected heart
beat.
Uterine activity will be continuously plotted on the
UA
channel of the stripchart paper. Pressure will be plotted
on a scale of 0-100 mmHg for internal pressure and 0-100
relative units for toco signals. If the recorder is turned
on, the message "TOCO" or "IUP" will be printed
20 seconds after connector insertion. Pressure exceeding
100mmHg will be printed as a straight line at 100 mmHg.
The uterine activity numeric values on the front panel dis-
play represent changes in pressure in either mmHg or
relative units. Depression of the UA reference pushbutton
for one second will reset the display to 0 mmHg (strain
gauge) or 10 (toco). Pushbutton should be activated for
internal monitoring when the strain gauge is open to air
and activated for external monitoring (toco) between
contractions.
If the relative pressure is greater than 100,
3
a " + " sign will flash continuously. Should the pressure
s
value exceed the monitoring range when the UA reference
button is depressed
- i.e. damaged toco or belt too tight -
the display will continuously flash " + 199". The message
"BASELINE PRESSURE OFF SCALE" will be printed on
the lower portion of the recorder's
UA channel after 20
seconds of baseline pressure less than 0 mmHg (or relative
units).

PREPmNG MOMTOR FOR USE
1) Plug power cord into rear panel connector (J101) and
into a hospital grade grounded electrical wall outlet.
2) Select a method of monitoring the fetus using either
FECG, ultrasound, or phono. Connect the appropriate
transducer plug to the corresponding colorcoded connector
on the front panel of the monitor.
3) Select a method of monitoring uterine activity using
either the tocotransducer or the
strain gauge. Connect
appropriate color-coded plug to the UA connector.

MOUNTING THE STWIN GAUGE
A) Place the rod of the strain gauge mount through
holes of the strain gauge clip.
B) Attach the strain gauge mount to the side of the
monitor by placing the lip of the top bracket into the
groove between the chassis and top cover of the monitor.
Place the bottom bracket in the groove
irm the bottom of
the monitor.
C) Tighten thumb screw enough to seat mount firmly.
D) Gently snap the strain gauge into the plastic clip.
E) Plug adapter end of
nector on monitor. cable into color-coded
UA con-

4) Set chart speed with slide switch on rear panel (3
cm/min is the generally accepted standard in the United
States).
5) Depress Power pushbutton on front panel.
When the power is first turned on, the following will occur:
A) The green "Power On" indicator will be lit.
B) The front panel heart rate numeric display will read,
"888" for three seconds.
C) The front panel UA display will read " + 188" for
three seconds.
D) All other front panel displays will light for three
seconds.
After the three second test period, the monitor
will be
ready to receive and display the
FNR and UA signals by
the chosen modes.
6) Insure an adequate supply of paper is in the recorder.
The recorder will automatically stop when paper runs out.
CAUTION: Use only recorder paper designed for use in the
Model
115 Monitor (CorometricsCatalog Number
4305AAO). Attempts to use paper suitable for other
recorders can damage the recorder's print head. (Cor-
ometrics Catalog Number 4303AAO is designed for other
Corometrics monitors and should not be used in the Model
115). Use of such papers may void the warranty.
CHART SPEED EGG (+80db)