Datascope cs100 Ballon Pump Service Manual PDF
Datascope cs100 Ballon Pump Service Manual PDF
VAULT COPY
Copyright © Datascope Corp., 2003. Printed in U.S.A. All rights reserved. Contents of this publication may not be repro-
duced in any form without permission of Datascope Corp.
1. Establish power and verify the MAINS ON/OFF and the IABP ON/OFF switches
are on.
6. Attach the IAB, with the appropriate catheter extender, to the safety disk
pneumatic connection labeled IAB Catheter Extender Input.
Foreword ........................................................................................................................................................ v
Warnings, Precautions and Notes...................................................................................................................... v
Warnings ....................................................................................................................................................... vi
Precautions ..................................................................................................................................................... xi
Indications for Use ........................................................................................................................................... xiv
Contraindications............................................................................................................................................. xiv
Brief Description of Intra-Aortic Balloon Therapy .................................................................................................. xv
Overview of Clinical Features............................................................................................................................ xvi
CS100 User Interface ....................................................................................................................................... xvii
CS100i Conversion Kit ..................................................................................................................................... xvii
Physical Description of the CS100 ..................................................................................................................... xviii
Mechanical and Transport Features.................................................................................................................... xviii
IABs Supported................................................................................................................................................ xix
Major Accessories ........................................................................................................................................... xix
How To Get Help............................................................................................................................................. xx
Unpacking Information ..................................................................................................................................... xxi
Symbols and Descriptions ................................................................................................................................. xxii
Controls and Indicators ..................................................................................................... 1 - 1
Introduction .................................................................................................................................................... 1 - 1
Operation Mode Keys ..................................................................................................................................... 1 - 2
Trigger Source Keys and Indicators ................................................................................................................... 1 - 5
IABP Control Keys ........................................................................................................................................... 1 - 8
Help Keys ...................................................................................................................................................... 1 - 12
Menu Guide................................................................................................................................................... 1 - 13
Menu Group Keys........................................................................................................................................... 1 - 14
Menu Navigation ........................................................................................................................................... 1 - 22
Opening a Submenu................................................................................................................................ 1 - 23
Changing a Setting.................................................................................................................................. 1 - 24
Changing a Numeric Parameter ................................................................................................................ 1 - 25
Immediate Action Keys .................................................................................................................................... 1 - 26
Display Screen ............................................................................................................................................... 1 - 28
Front Panel..................................................................................................................................................... 1 - 38
Rear Panel ..................................................................................................................................................... 1 - 39
Special Mode Activation.................................................................................................................................. 1 - 42
Detailed Operation ........................................................................................................... 2 - 1
Introduction .................................................................................................................................................... 2 - 1
Operation Instructions ..................................................................................................................................... 2 - 2
Safety Disk Leak Test ................................................................................................................................ 2 - 2
Power Up Procedure (Without Safety Disk Leak Test) .................................................................................... 2 - 3
Open Helium Tank Valve and Confirm Helium Pressure ................................................................................ 2 - 3
Connect IAB and IAB Catheter Extender to IABP Console.............................................................................. 2 - 4
ECG Acquisition...................................................................................................................................... 2 - 4
Arterial Pressure Acquisition...................................................................................................................... 2 - 6
Selection of Trigger Source ....................................................................................................................... 2 - 7
Selection of IAB Frequency ....................................................................................................................... 2 - 11
Timing of Intra-Aortic Balloon .................................................................................................................... 2 - 12
Verify Arterial Pressure Delay .................................................................................................................... 2 - 13
Initiation of Assist .................................................................................................................................... 2 - 14
IAB Fill / Autofill / Manual Fill .................................................................................................................. 2 - 15
Troubleshooting................................................................................................................ 3 - 1
Introduction .................................................................................................................................................... 3 - 1
ECG Troubleshooting ............................................................................................................................... 3 - 2
Trigger Troubleshooting............................................................................................................................ 3 - 2
Balloon Troubleshooting ........................................................................................................................... 3 - 3
Power-up Troubleshooting ......................................................................................................................... 3 - 3
Alarms, Alerts and Advisories........................................................................................................................... 3 - 4
Alarm and Advisory Table ........................................................................................................................ 3 - 4
Help Screens .................................................................................................................................................. 3 - 13
Clinical.......................................................................................................................................................... 3 - 27
Water Condensation................................................................................................................................ 3 - 27
Clinical Considerations During Operation .................................................................................................. 3 - 28
Use in Electro-surgical Environment ............................................................................................................ 3 - 29
Use During Cardiopulmonary Bypass ......................................................................................................... 3 - 30
Weaning a Patient from IABP Support ........................................................................................................ 3 - 30
Doppler Information ................................................................................................................................. 3 - 31
Manual Fill Mode ........................................................................................................................................... 3 - 32
Printer .............................................................................................................................. 4 - 1
Printer Operation ............................................................................................................................................ 4 - 1
Printer Formats................................................................................................................................................ 4 - 2
Trailer Annotations .......................................................................................................................................... 4 - 4
Portable/Transport Operation........................................................................................... 5 - 1
Hospital Cart.................................................................................................................................................. 5 - 1
Portable Operation ......................................................................................................................................... 5 - 2
Battery Operation .................................................................................................................................... 5 - 2
Battery Charging ..................................................................................................................................... 5 - 3
Switching from AC to Battery Operation..................................................................................................... 5 - 3
Operation From External DC Source (CS100i only) ..................................................................................... 5 - 3
Operation from DC-to-AC Inverter .............................................................................................................. 5 - 4
Effects of Altitude Changes During Air Transportation................................................................................... 5 - 4
Portable Operation Emergency Battery Back Up Recommendations................................................................ 5 - 5
Removing Pump Console from the Cart....................................................................................................... 5 - 5
Universal Transport Systems (UTS) ..................................................................................................................... 5 - 8
Use of the Light Weight Docking Station (P/N 0436-00-0110) and Mobilizer ................................................ 5 - 9
Pediatrics.......................................................................................................................... 6 - 1
Pediatric Balloon Pumping ............................................................................................................................... 6 - 1
Pediatric Adapter Installation .................................................................................................................... 6 - 1
Safety Chamber Leak Test (Pediatric).......................................................................................................... 6 - 3
Normal Power Up Procedure .................................................................................................................... 6 - 3
Establish Fill Gas Pressure......................................................................................................................... 6 - 3
Initial Set-up for Pediatric Balloon Pumping ................................................................................................. 6 - 4
Timing of Pediatric Balloon Pumping .......................................................................................................... 6 - 4
Filling Pediatric Catheters ......................................................................................................................... 6 - 5
Initiation of Assist (Pediatric) ..................................................................................................................... 6 - 7
User Maintenance ............................................................................................................. 7 - 1
Introduction .................................................................................................................................................... 7 - 1
Chart Paper Loading ....................................................................................................................................... 7 - 2
Installation and Replacement of Helium Cylinder................................................................................................. 7 - 3
Installation of Helium Cylinder Strap.................................................................................................................. 7 - 5
Standard Helium Cylinder Strap ................................................................................................................ 7 - 5
Helium Cylinder Strap with Bracket Adapter ............................................................................................... 7 - 6
Helium Cylinder Refilling Information................................................................................................................. 7 - 7
Safety Disk/Condensate Removal Module.......................................................................................................... 7 - 8
User Maintenance Between Pumping Procedures ................................................................................................ 7 - 10
Cleaning ................................................................................................................................................ 7 - 10
Printer ......................................................................................................................................................... 11 - 6
Power.......................................................................................................................................................... 11 - 7
Power Requirements............................................................................................................................... 11 - 7
Internal Battery ...................................................................................................................................... 11 - 7
External Battery Pack (CS100i only)......................................................................................................... 11 - 7
Physical Characteristics ................................................................................................................................. 11 - 8
Weight................................................................................................................................................. 11 - 8
Mechanical Dimensions.......................................................................................................................... 11 - 9
Environment (CS100) .................................................................................................................................... 11 - 10
Operating Ambient................................................................................................................................ 11 - 10
Storage Ambient ................................................................................................................................... 11 - 10
Shipping .............................................................................................................................................. 11 - 10
Vibration/Shock .................................................................................................................................... 11 - 10
Environment (CS100i) ................................................................................................................................... 11 - 13
Operating Ambient................................................................................................................................ 11 - 13
Storage Ambient ................................................................................................................................... 11 - 13
Shipping .............................................................................................................................................. 11 - 13
Vibration/Shock .................................................................................................................................... 11 - 13
Electro-Magnetic Compatibility (CS100/CS100i) ............................................................................................. 11 - 15
ESU Rejection........................................................................................................................................ 11 - 20
Safety Characteristics .................................................................................................................................... 11 - 21
Risk (Leakage) Currents .......................................................................................................................... 11 - 21
Dielectric Withstand............................................................................................................................... 11 - 21
Ground Resistance................................................................................................................................. 11 - 21
Agency Compliance...................................................................................................................................... 11 - 22
Safety Designations....................................................................................................................................... 11 - 23
Safety designations per IEC 60601-1 Standard......................................................................................... 11 - 23
Foreword
This manual is intended to provide information required to properly operate the Datascope
CS100 Intra-Aortic Balloon Pump. For additional information and assistance, please contact
the Datascope Cardiac Assist Representative in your area.
General knowledge of balloon pumping and an understanding of the features and functions
of the CS100 are prerequisites for the proper use of this equipment. Therefore, DO NOT
OPERATE THE EQUIPMENT BEFORE READING THESE INSTRUCTIONS AND THE
WARNINGS, PRECAUTIONS AND NOTES WHICH FOLLOW.
Datascope maintains a policy of continual product improvement and reserves the right to
change materials and specifications without notice.
A NOTE is provided when extra general information is applicable. Notes appear in the
appropriate areas throughout the manual.
Warnings
WARNING: Do not operate this system before thoroughly reading this
manual and the associated warnings and precautions. Only
use the Abbreviated Operating Guide if you are already
familiar with this product. If not, please continue with the
remainder of this manual.
WARNING: Do not use the CS100 IABP during or near a MRI (Magnetic
Resonance Imaging) scanner.
WARNING: Safety Disk Leak Test MUST NOT be performed when the
system IAB is connected to the patient.
WARNING: Never leave the system set in the Internal Trigger Mode
when the patient is generating a cardiac output.
WARNING: In the manual timing mode, if the heart rate varies by more
than 10 bpm, readjustment of timing may be required.
WARNING: Do not inflate the IAB using a syringe or any other means if
a balloon leak is suspected.
WARNING: The patient balloon should not remain inactive in the patient
(i.e., no inflating and deflating) for more than 30 minutes,
due to the potential for thrombus formation.
WARNING: Route cables neatly. Ensure cables, hoses and wires are
away from patient's neck to avoid strangulation. Keep
floors and walkways free of cables to reduce risk to
hospital personnel, patients and visitors.
WARNING: This unit uses a common isolation path for the ECG leads
and the Invasive Pressure Channels. Ensure that conductive
parts of the ECG electrodes do not contact other conductive
parts including earth ground. Do not connect any non-
isolated accessories to the CS100 or to the ECG or invasive
pressure channel inputs when connected to a patient. Insure
that the total chassis leakage currents of all connected units
does not exceed 300µA. Use an IEC 60601-1 approved
isolation/separation transformer if required. Do not
simultaneously touch the patient and any piece of electrical
equipment if any cover has been removed from the
equipment.
WARNING: Do not connect other equipment to the same MPSO with the
CS100, as it may increase system leakage current.
WARNING: When the CS100 is operated in the Manual Fill mode, the
IAB Catheter and Gas Loss Alarms are disabled. The
message “Gas Loss and Catheter Alarms Disabled” will be
displayed in the Advisory section of the display. The IAB
status bar will not be active. Therefore, use of the Low
Augmentation Alarm is essential in pediatric IAB patient
care. By setting the Low Augmentation Alarm, the system
monitors the level of assist and alerts the user in the event
that diastolic augmentation has dropped below the alarm
limit.
WARNING: The Autofill mode should be used during air transport. If the
Autofill mode cannot be used and the Manual Fill mode is
required, ensure that a manual fill is performed at each
interval and altitude that an Autofill would occur.
WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB FILL mode. Consequently, the
use of the augmentation alarm is essential when caring for
patients while operating in this mode.
WARNING: Do not remain in the internal trigger mode when the patient
is generating a cardiac output.
WARNING: Never use a glass syringe for the Manual Fill Procedure.
Possible injury may occur if glass breaks. Hold your hand
over the syringe plunger.
Precautions
CAUTION: Blood pressure transducers used with the CS100 shall meet
the standard for interchange ability and performance as
defined by AAMI Spec BP-22-1994 “Blood Pressure
Transducers”.
CAUTION: The internal batteries are charging only when the AC Mains
plug is connected to an active AC Mains source, the AC
Mains switch is ON, and the battery charging status LED is
illuminated. This charging condition must be maintained
even when the system is not in use. Note that 18 hours of
charging is required to fully charge the batteries.
CAUTION: When power cycling the unit, power off for a minimum of
10 seconds before powering on again.
CAUTION: When the optional Protective Cover is on, do not leave the
CS100 on and powered-up (i.e., with the IABP On/Off
switch in the ON position).
CAUTION: Never place fluids on top of this unit. Make sure that the
saline container and tubing do not hang directly over the
IABP. In case of accidental spillage, wipe clean immediately
and have the unit serviced to ensure no hazard exists.
CAUTION: Do not operate the unit with the ventilation or speaker vents
obstructed.
CAUTION: If the contents of the syringe are not drawn into the safety
disk DO NOT resume balloon pumping. Return to step 5 in
the Manual Fill Procedure, paying careful attention to
syringe fill volume. If second attempt fails, there most likely
is a leak at one of the safety disk ports or stopcock and they
should be checked.
CAUTION: When the system is not in use, close the cylinder valve fully
clockwise to prevent a potential leak and the depletion of
the Helium supply.
CAUTION: Insure that the wheels of the cart are in the locked position
when removing the pump console from the cart or returning
the pump console to the cart.
CAUTION: Lifting the IABP by the Lower Lift Handles requires two
people. While lifting, the IABP must be steadied by placing a
free hand near the top of the unit to provide stability.
CAUTION: When in Manual Fill Mode, the IAB should be re-filled every
2 hours when using adult IABs and every 45 minutes when
using pediatric IABs.
The target populations are adult and pediatric. The balloon pump is intended for use in the
health care facility setting.
Contraindications
• Severe aortic insufficiency
• Abdominal or aortic aneurysm
• Severe calcific aorta-iliac disease or peripheral vascular disease
• Introduction of the IAB catheter without the use of an introducer sheath is not
recommended for patients with severe obesity, scarring of the groin or other
contraindications to percutaneous insertion
Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of
the cardiac cycle. This increase in aortic pressure forces more blood flow through the
coronary arteries.
Left ventricular work is reduced by reducing the amplitude of blood pressure during the
systolic phase of the cardiac cycle.
These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon
(IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly
synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the
dicrotic notch. The IAB is held inflated through diastole and is deflated at, or just prior to, the
onset of systole. The balloon is held in the deflated state throughout systole.(Hence, the
therapy is also called counter-pulsation).
The CS100 has three operation modes: AUTO, Semi Auto and Manual. The AUTO
operation mode provides simplicity and minimizes operator intervention. The Semi Auto
and Manual operation modes provide operators with flexibility for difficult clinical cases.
When the AUTO operation mode is selected, all aspects of IABP operation are automated.
The CS100 automatically selects the best available trigger source and automatically sets IAB
timing. In the event of a loss of trigger source (e.g., a lost ECG lead), the CS100 will
sequentially search for the next best available trigger source and then reset timing
accordingly. Timing is also reset on a periodic basis or if the patient's heart rate or rhythm
changes significantly.
As the name indicates, when in the Semi Auto operation mode, IABP operation is partially
automated. The operator is responsible for both selection of the trigger source and for initial
timing of the IAB. Thereafter, the IABP's timing algorithms will adjust timing in response to
changes in heart rate or rhythm. If the trigger source is lost the IABP alarms. This operation
mode provides the most flexibility for difficult clinical cases.
In the Manual operation mode, the operator is responsible for selection of a trigger source
and setting IAB timing. The operator is also responsible for maintaining correct timing in the
event of a change in patient heart rate and rhythm. This mode is used only in exceptional
cases, such as pediatrics, where a large range of timing settings must be accommodated.
Loss of trigger will result in an alarm.
In all operation modes, the processes of Helium purge and replacement, and condensate
removal are fully automatic. Operator intervention is not required for these functions.
For emergency use, the CS100 has a rapid startup feature. This feature is active at power
up. The rapid start up feature performs the following steps:
For operator convenience, and to facilitate its use in emergencies, the CS100 is highly
automated. Dedicated keys are used for functions that are frequently used or for functions
which must be accessed rapidly.
A context sensitive help system is available to assist users with alarms and common tasks. The
help system presents probable causes for alarms and recommended corrective action.
In order to provide flexibility, the CS100 operates via a menu driven system. The menu
system provides a logical and consistent method for accessing system controls and functions.
The CS100i differs from a factory CS100 in that it retains the environmental specifications of
the original host System. Hence, a CS100i has the environmental, shock and vibration, and
external DC power specifications of a System 98/98XT. Hereafter, areas of difference in
specification or function are noted by the reference to CS100i.
The display/control module consists of a keypad which is attached to a color flat panel
display via a hinge. Therefore the display can be tilted and rotated to achieve the best
viewing angle. The module receives power and exchanges data with the console via a cable
(coil cord). Functionally, the module centralizes all key aspects of the operator interface with
the system. It integrates the functions of the patient monitor and the control panel. Remote
operation of the IABP is possible by detaching the control/display module.
The console houses the following: Patient Interface Electronics (Electrically Isolated), Patient
Pneumatic Isolator (Safety Disk), Drive Pneumatics, Shuttle Gas Supply, Condensate Removal
System, Printer, Control Electronics, Power System (Battery and AC Mains) and Data
Communications Interface.
Due to its small footprint, the CS100 can be used in ambulances, helicopters, and fixed
wing aircraft. The CS100 automatically refills the IAB on ascent and descent in order to
acclimate IAB pressure to ambient pressure changes. It is rated for an altitude of 12,000
feet.
The System can be powered from either AC Power (115/230 VAC, 50/60 Hz) or built-in
batteries. If AC power is not available, the CS100 automatically utilizes internal battery
power.
IABs Supported
The CS100 is designed for use with the Adult Safety Disk which interfaces with all
Datascope adult intra-aortic balloons (25, 34, 40, and 50 cc).
The CS100 is also designed for use with Pediatric IABs. Two large pediatric intra-aortic
balloon sizes (12 and 20 cc) require the use of an optional Pediatric Adapter Hose and
Adult Safety Chamber to be used in place of the Adult Safety Disk. Smaller Pediatric IABs
(2.5, 5, and 7 cc) require the use of the optional Pediatric Adapter Hose and a small
Pediatric Safety Chamber to be used in place of the Adult Safety Disk.
Major Accessories
An ultrasonic doppler is included in the top compartment of the hospital cart. The doppler
is used to verify arterial blood flow in a non-invasive manner.
A two compartment accessory case allows storage of a trainer, a manual and IAB
supplies. A protective cover is also available for the system. A remote monitor mount and
extension cable are available for mounting the monitor/keypad module in the operating
room.
Domestic Service
For Datascope U.S., Canada, and Latin America Service, please contact:
Unpacking Information
The CS100 is shipped as a complete unit in a single shipping container.
Accessories and gas cylinders are shipped separately. Please contact an authorized
Datascope representative prior to placing the CS100 into service.
Dangerous Voltage
Standby
1.1 Introduction
This section of the Operating Instructions identifies and describes each feature and control of
the CS100. See “Detailed Operation” on page 2-1, for more specific instructions.
OPERATION MODE
Zero
Semi START STANDBY
AUTO Manual Pressure
Auto
Hold 2 Sec.
Pediatric Only
User Print
Preferences Strip
Hold for continuous
Back
The CS100 has three operating modes, AUTO, Semi Auto and Manual. The AUTO
operation mode provides simplicity, and the Semi Auto and Manual operation modes
provide versatility. The default operation mode is AUTO.
The choice of operation mode strongly effects the system’s behavior and the user interface.
For example, when the system is in AUTO, many of its controls are not required and are
therefore disabled. Conversely, when in the Semi Auto or Manual operation mode, these
controls are enabled.
Each operation mode key has an LED indicator which illuminates to indicate that the mode is
selected. Operation mode keys are used to select the automation and control used by the
IABP in its application of therapy to the patient. Selection of any operation mode key cancels
the previous selection. Any transition between operation modes stops assist and places the
system in STANDBY mode. Assist may be resumed by pressing the START key.
1. AUTO Key
Pressing this key places IABP operation in the AUTO operation mode. When the IABP is
operating in AUTO operation mode, operation is completely automatic. The IABP
automatically selects the most appropriate Trigger Source. Then the IABP automatically
sets inflate and deflate timing. No operator intervention is required. For flexibility, deflation
timing can be fine tuned via use of the IAB DEFLATION keys.
In this fully automatic mode, there is no operator selection or override of the trigger source. In
the event that the trigger source is lost, the IABP automatically selects the next best available
trigger and re-times the IABP, if appropriate. Similarly, if a superior trigger source is made
available, it is automatically selected and timing is reset.
The system's software algorithms automatically track changes in patient heart rate or rhythm
and adjust the inflation and deflation points accordingly. When the patient's rhythm is not
adequately predictable, and a valid ECG trigger is available, R-Wave deflation is
automatically selected. This surveillance is continuous. It continually monitors the patient's
rhythm and selects R-Wave deflation when it is the most appropriate. This is indicated via the
Deflation Timing Indicator and the Auto R-wave Deflate advisory message on the
display.
Assist is automatically suspended when making the transition to AUTO operation mode from
another operation mode. Resume assist by pressing the START key.
In this operation mode, the operator selects the most appropriate TRIGGER SOURCE. Then
the operator sets IAB INFLATION and DEFLATION (See Figure 1-3). Software algorithms
automatically track changes in patient heart rate or rhythm and adjust the inflation and
deflation points accordingly.
When the patient's rhythm is not adequately predictable, and a valid ECG trigger is
available, R-Wave deflation is automatically selected. This surveillance is continuous. It
continually monitors the patient's rhythm and selects R-Wave deflation when it is the most
appropriate. On the display, the status message Auto R-Wave Deflate is shown when R-
Wave Deflation has been selected.
In this operation mode, loss of the trigger source will result in a No Trigger alarm. Trigger
source selection is not automated, it is the responsibility of the operator.
When this timing mode is selected, the system will immediately stop assist and enter
STANDBY mode. This is done to emphasize the need for operator intervention when
entering this operation mode. The operator should re-assess timing when the trigger source is
changed. Assist may be resumed by pressing the START key.
Similarly, when a new trigger source is selected, and timing has not been set by the operator,
the system will immediately stop assist and enter STANDBY mode. This is done to
emphasize the need for initial operator intervention when changing trigger sources. The
operator should re-assess timing when trigger sources are changed. Assist may be resumed
by pressing the START key.
3. Manual Key
When the Manual operation mode is selected, the timing of IAB Deflation and Inflation
is exclusively determined by operator selection, using the IAB INFLATION and IAB
DEFLATION timing keys.
In this mode, the inflate and deflate points do NOT automatically change to match changes
in patient rate or rhythm. Consequently, increased operator vigilance is required to assure
that the proper timing is maintained. Typically, this mode is used for pediatric cases or other
cases where additional timing range is needed. See “Pediatric Balloon Pumping” on page 6-
1, for a detailed description of the Manual operation mode.
When this timing mode is selected, the system will immediately stop assist and enter
STANDBY mode. This is done to emphasize the need for operator intervention when
entering this operation mode. Assist may be resumed by pressing the START key.
OPERATION MODE
Semi Zero
AUTO Manual START STANDBY
Pressure
4 Auto
Hold 2 Sec.
Pediatric Only
5
TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION
6 ECG 1:1
MAX Earlier Later Earlier Later
Pressure
1:2
7 Pacer V / AV
Pacer A 1:3
Internal OFF
8
9
Ref ECG / AP Inflation
Alarm
Help Line Interval
Mute Sources
User Print
Preferences Strip
Back
The trigger signal source selections are ECG, Pressure, Pacer V/AV, Pacer A and
Internal.
Irrespective of the operation mode, the active trigger source is indicated by illumination of
the appropriate LED on the keypad. The active trigger source is also shown in the in the
upper right hand corner of the display in the Trigger Source field.
5. ECG Trigger
This indicates that the patient's ECG is currently selected as the active trigger source for the
IABP. The system will trigger on the patient's R-Wave. The ECG signal source can be from
either patient electrodes or an external ECG signal from a patient monitor.
If a pacemaker is detected while in ECG trigger mode, it will be ignored and the system will
trigger on the patient's QRS complex. Detected pacer pulse signals are enhanced on the
display. They are shown as spikes.
In the AUTO operation mode, the best available skin lead (I, II, III) or External ECG
source is automatically selected. If these sources are exhausted, then Pressure Trigger
mode may be automatically selected. An automatic change in trigger source can be
provoked by electro-surgical noise, motion artifact or loss of electrodes.
In the Semi Auto and Manual operation modes, the operator can change the ECG trigger
source (I, II, III, aVR, aVL, aVF, V or External) via the ECG/AP Source menu.
In all cases, the Trigger field on display shows the currently active ECG source and lead.
Similarly, the ECG waveform on the display reflects the currently active ECG trigger source.
6. Pressure Trigger
This indicates that the patient's arterial blood pressure is currently selected as the trigger
source for the IABP. The system will trigger on the systolic upstroke of the patient's arterial
pressure waveform. The signal source can be either the direct pressure transducer (e.g., IAB
inner lumen) or an external pressure signal.
To facilitate rapid startup while in Pressure Trigger, assist can be initiated without zeroing
the transducer. However, zeroing is necessary to support the numeric display of patient
parameters.
In the AUTO operation mode, the best available source for arterial pressure is selected.
Preference is given to the IAB's pressure transducer. If it is unavailable, then the external
arterial pressure source is automatically selected. If all potential valid signal sources are lost,
then a No Trigger alarm will sound. An automatic change to this trigger mode can be
provoked by electro-surgical noise, motion artifact or loss of electrodes.
In the AUTO operation mode, the operator can manually change the pressure source. If
however the pressure source, selected by the operator, becomes unavailable or its trigger
was lost, the CS100 will automatically select the alternate pressure source, if available.
In the Semi Auto and Manual operation modes, the operator selects the source for arterial
pressure trigger (Direct vs. External) via the ECG/AP Source menu.
Use of this mode requires that the patient is 100% paced and captured (i.e., no demand
pacing). The ECG signal source can be from patient skin electrodes or an external ECG
signal from a patient monitor.
This trigger mode is often selected when the patient is paced and the resultant QRS response
is too weak to be a reliable trigger source (e.g., operating room usage.)
8. Pacer A Trigger
This trigger mode is available in the Semi Auto and Manual operation modes and must
be selected by the operator.
This mode is recommended for use only when the tails of an atrial pacer interfere with
R-Wave detection. Either fixed or demand atrial pacers can be used in this trigger mode.
In this trigger mode, patient's ECG is used as the trigger source for the IABP. The system will
trigger on the patient's R-Wave and reject interference from atrial pacer artifact. The ECG
signal source can be either patient electrodes or an external ECG signal.
9. Internal Trigger
This trigger mode is available in the Semi Auto and Manual operation modes and must
be selected by the operator.
This indicates that the IABP's Internal trigger source is selected as the trigger source for the
IABP. The system will trigger at a fixed rate, as defined by internal rate in the PUMP
OPTIONS menu.
This trigger mode should not be used when a viable QRS is present. When in this mode, the
system automatically deflates the IAB when an R-Wave is detected, to prevent asynchronous
assist. Also, an alert message that reads ECG Detected and a tone, are generated.
This mode is typically used in the OR during CABG procedures. It is used when the patient is
on bypass and no QRS is present. Assist is recommended when in full bypass to prevent clot
formation on the IAB membrane.
OPERATION MODE
Semi Zero
AUTO Manual START STANDBY
Auto Pressure
15
Hold 2 Sec.
Pediatric Only
Alarm
Mute
Help
Ref
Line
ECG / AP
Sources Inflation 16
Interval
User Print
Preferences Strip
17
Hold for continuous
Back
The selected IAB frequency is indicated by an illuminated LED. When either 1:2 or 1:3 is
selected, both the assisted and unassisted systolic and diastolic pressures are numerically
displayed and may be printed. They are labeled accordingly.
Changes in IAB FREQUENCY are commonly made by operators to assess timing or reduce
assist (wean patients from IAB therapy).
This control is often used during the weaning process, where the amount of augmentation is
reduced over a course of time to wean the patient from IAB therapy.
Press and hold this key for two (2) seconds to zero the direct pressure transducer. (The
zeroing function accommodates pressure transducers with offsets of up to ±120 mmHg.)
The displayed patient blood pressure parameters are only valid if the transducer has been
properly zeroed. If the transducer has not been zeroed or if the process is unsuccessful, then
the message NO ZERO is displayed in the systolic field of the patient’s blood pressure
parameter on the display.
If the offset of the transducer exceeds the valid limit of ±120 mmHg then the advisory
message NO ZERO will be posted in the systolic field of the display. (This might occur in
cases where the transducer is defective or if the transducer is not vented to atmosphere when
Zero Pressure is pressed.)
Pressing the START key at power-up automatically initiates the IABP's rapid start feature. This
feature expedites the start of IAB assist. The rapid start feature automatically performs the
following steps:
These keys are used to adjust the time duration between the trigger event and the beginning
of the IAB inflation. Each time a key is pressed, the inflation point is moved one increment.
The keys repeat their function if held.
The inflation timing indicator (displayed directly under the Blood Pressure Waveform) moves
in response to inflation changes. Also, the highlighted area on the blood pressure waveform
will move in response to changes in the inflate setting.
Deflation is automatically set in the AUTO operation mode. The IAB DEFLATION keys are
disabled in AUTO operation mode, except when ECG triggering is active. In this case, user
modification of the automatically established deflation point is permitted but NOT required.
Unlike inflation, deflation timing practices can vary considerably and this option allows users
the flexibility to tailor deflation to personal or institutional preference.
Detecting the early occurrence of a cardiac cycle will produce an immediate start to
deflation, overriding the scheduled deflation point.
Each time a key is pressed, the deflation point is moved one increment. The keys repeat their
function if held.
The deflation timing indicator (displayed directly under the Blood Pressure Waveform) moves
in response to deflation changes. Also, the highlighted area on the blood pressure waveform
will move in response to changes in the deflate setting.
The LATER key can be used to manually select R-Wave Deflation mode. In this mode, IAB
deflation is initiated upon detection of the R-Wave. This mode is only active when the trigger
source is ECG or PACER A. To select this deflation mode, the LATER key must be held down
until the IAB deflation indicator moves to the extreme right (this movement is facilitated by the
repeating action of the key). The deflation indicator should now display “4.0” and this
timing selection will be confirmed by the advisory message R-Wave Deflate.
Since the CS100 automatically purges and replaces the shuttle gas every two hours,
operator intervention is not normally required. Consequently, this key is used infrequently.
Typically, it is used in conjunction with an alarm. The help screens suggest corrective action
for alarms. In some cases, a manually initiated fill process is suggested.
This key has a secondary function which is active solely at power-up. It can be used to select
the Safety Disk Leak Test. This is done by pressing and holding the key while simultaneously
turning the power switch to ON. A prompt on the display will confirm that the test has been
selected. See “Safety Disk Leak Test” on page 2-2, for additional information.
Zero
Semi START STANDBY
AUTO Manual Pressure
Auto
Hold 2 Sec.
Pediatric Only
18
User Print
Preferences Strip
19
Hold for continuous
Back
Help text information is available upon initial setup and during alarm conditions. A message
on the display states either Help available for initial setup upon power-up or Help
available for Alarm/Advisory during assist.
Ref. ECG/AP
Line Sources
Pump
Options
Display Preferences
Sweep Speed
Balloon Waveform
Brightness
ECG Inflation Markers
Flash Alarms
Audio Preferences
Alarm Volume
Standby Advisory Tone
Beep Volume
Printer Preferences
First Waveform
Second Waveform
Strip Length
Menu Guide Timed Print
24hr. Emergency Helpline Print on Alarm
Print Trigger &
1.800.777.4222 (U.S.)
Alarm Log
1.201.995.8000 (INTL.) Set Time and Date
Zero
Semi START STANDBY
AUTO Manual Pressure
Auto
Hold 2 Sec.
Pediatric Only
MAX
21
ECG 1:1 Earlier Later Earlier Later
Pressure
1:2
Pacer V / AV
Pacer A 1:3
Internal OFF
26 23
Alarm
Mute
Help
Ref
Line
ECG / AP
Sources
Inflation
Interval 24
Back
22 20
Default Settings: If the system is switched OFF for less than 15 minutes, trend data and
the user settings, accessible via the Menu Group keys, are retained. If the system is OFF for
more than 15 minutes, default settings are restored. Default settings are listed in the tables in
this section. To adopt default settings without waiting for 15 minutes of power OFF, press and
hold the Open Menu key while switching the system ON.
The menu items in ECG/AP Sources are effected by the operation mode and are described
in the following table.
ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
ECG Lead Defines ECG lead used No Operator Automation will seek to use
Source for triggering and Selectable Items ECG trigger when possible
waveform display (Lead I,II, III or Ext. Loss of ECG Lead will
are selected by
result in search for an
Automation)
alternative ECG Lead
If no skin ECG is valid, Ext.
will be used, if available
Pressure Defines source of Direct, External Pressure trigger will be
Source pressure signal used for used if no valid ECG is
triggering and available
AUTO OPERATION MODE
waveform display
Automation will seek best
available pressure source
if no ECG and both
pressure sources are
present. If both Direct and
External pressure sources
are available, and both the
ECG and preferred
pressure sources are lost,
then the system will ignore
the selected preference
and trigger on the
alternative pressure source
(if valid). If all trigger
sources are found to be
invalid, it will alarm "NO
TRIGGER." Restoration of a
valid ECG source will
result in a return to ECG
trigger
ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
ECG Lead Defines ECG lead used I, II, III, aVR, aVL, If the selected ECG Lead is
ITEM
NAME DESCRIPTION OPTIONS COMMENTS
ECG Gain Defines the gain applied No operator Manual Gain settings are
to ECG signal used for selectable items unavailable
triggering and ECG Gain is automatically
waveform display
set
Pressure Defines trigger threshold No operator Manual Threshold settings
Threshold on systolic upstroke. selectable items are unavailable
Triggering occurs when Pressure threshold is
the systolic pulse height
automatically set
(Height = Peak systole -
End Diastole) exceeds
the trigger threshold.
Internal Sets rate used when No operator This function is unavailable
AUTO OPERATION MODE
ITEM
NAME DESCRIPTION OPTIONS COMMENTS
ECG Gain Defines the gain applied Normal (1X), Manual Trigger Source must be:
to ECG signal used for (0.15X to 3.0X) ECG, Pacer V/AV or
triggering and Pacer A to access
waveform display Default: 1X Manual Gain Settings
Pressure Defines trigger threshold Automatic, Manual Trigger Source must be
Threshold on systolic upstroke. (7 to 30 mmHg) Pressure to access
Triggering occurs when Manual Threshold Settings
the systolic pulse height Default: Automatic
(Height = Peak systole -
End Diastole) exceeds
the trigger threshold.
SEMI AUTO AND MANUAL OPERATION MODES
Internal Sets rate used when Internal Rate = Trigger Source must be
Rate Internal trigger is 40 to 120 bpm Internal to access
selected Manual Rate Settings
Default: 80
The advisory ECG
Detected will be displayed
if ECG is detected while in
this mode
SLOW Enables or Disables the On, Off Unaffected by operation
GAS Slow Gas Loss Alarm. mode
ALARM This alarm is used to Default: On
detect the slow loss of
shuttle gas from the
IAB's pneumatic circuit.
IAB FILL Defines if the IAB's AUTO, Manual Autofill mode is preferred
MODE shuttle gas is purged Manual fill mode is
and filled Automatically Default: AUTO
typically used for pediatric
by the CS100 every 2
cases, or in the event of a
hrs., or manually by the failure of the automatic fill
Operator system.
Arterial Displays the currently Automatic, Manual Automatic measurement of
Pressure measured APD and Manual adjustment APD occurs as needed
Delay provides for manual range is 0 to 180 An additional
setting measurement of APD can
Default: 40 ms, then
be initiated by pressing the
automatic adjustment
Inflation Interval key
while assisting
Manual entry of APD is
used in pediatric cases
R-Trac Enables or disables the On, Off R-Trac is not available in
automatic activation of Manual operation mode.
R-Wave Deflation for Default:
tracking unpredictable On (Semi-Auto)
rhythm patterns. Off (Manual)
ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
Sweep Sets the sweep speed of 25 mm/sec, 50 mm/
Speed the display's waveforms sec
and printer
Default: 25 mm/sec
DISPLAY PREFERENCES SUBMENU
Default: High
Balloon Enables or disables On, Off See “Display Screen” on
Waveform display of the Balloon page 1-28, for information
Pressure Waveform Default: As Last Set on the Balloon Pressure
Waveform
ECG Enable or disables On, Off See “Display Screen” on
Inflation display of the ECG page 1-28, for information
Markers markers Default: As Last Set on the ECG Inflation
Markers
Flash Enables or disables On, Off In noisy environments, it
Alarms flashing of the display may be helpful to flash
when an alarm Default: Off alarm messages. If this is
condition is active. the case, set to ON
ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
Alarm Adjustment of Alarm 1 to 8 When this option is
ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
First Defines which waveform ECG, Arterial, See “Printer” on page 4-1,
Waveform at the top of printout Balloon for a discussion of printer
formats
Default: ECG
Second Defines which waveform Off, ECG, Arterial, See “Printer” on page 4-1,
Waveform is printed at the bottom Balloon for a discussion of printer
of the printout, or formats
disables printout of a Default: Arterial
second waveform
Strip Defines the length of a 6, 8,15,30,
PRINTER PREFERENCES SUBMENU
ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
Set Time Sets Time and Date used Set Time and Date via
Press the Ref Line key to activate the reference line. When activated, this function closes
any open menu. The reference line position becomes controlled by the UP and DOWN
arrow keys located in the Navigation Circle.
The Augmentation Alarm limit is automatically set at the initiation of assist (the pressure
transducer must be zeroed). The automatic augmentation alarm limit is determined by an
adaptive process which sets the alarm to 10 mmHg below the patient's augmented diastolic
pressure.
To reset or change the augmentation alarm limit, press the Aug Alarm key. Once activated,
this function closes any open menu. The augmentation alarm limit becomes controlled by the
UP and DOWN arrow keys in the Navigation Circle. These keys increment/decrement the
augmentation alarm limit by 2 mmHg. The alarm limit is displayed in the Aug. Alarm field of
the CS100 Display. The available alarm settings range from 60 to 200 mmHg.
To disable (turn off) the Augmentation alarm, use the UP or DOWN arrow keys to set the
alarm limit to OFF.
Pressing either the Aug Alarm key (while active), or any other function/menu key will
cause the indicator to be extinguished, indicating that the Navigation Circle arrow keys no
longer control the augmentation alarm limit.
The highlighted bar is always used as a pointer (cursor) to select menu entries. Only one item
can be selected at a time. Where applicable, the highlighted bar is also used to identify the
current setting associated with a selected item.
The arrow keys in the menu navigation circle control the movement of the highlighted bar.
Therefore, they define which item in a list is selected.
To select an alternative item, use the UP and DOWN arrow keys, located in the navigation
circle, to move vertically within the list.
To reverse the effect of a setting selection, use the navigation keys to re-select the original
setting.
In cases where numeric entries are needed (e.g., setting the date or time) the navigation
circle's LEFT or RIGHT arrow keys are used to select the digit of interest, and the UP and
DOWN arrow keys are used to increment or decrement the value.
Submenus are shown as a single string of text. They do not expand when highlighted. To
open a submenu, use the navigation circle's UP and DOWN arrow keys to highlight the
name of the menu. Then press the Open Menu key to open the submenu.
To close a menu or submenu, press the Back key. This will move back to the parent menu. If
a parent menu does not exist, then the menu is closed and the display is returned to its
normal state. Therefore, successive depressions of the Back key will result in a quick exit
from the menu system.
Menus can also be exited by a second press of the active menu key or by selecting a
different menu family key.
USER PREFERENCES
By default when opened the first menu
DISPLAY PREFERENCES item is selected.
AUDIO PREFERENCES To close this menu, press either the Back
key in the menu navigation circle, or press
PRINTER PREFERENCES any menu key, (e.g., ECG/AP, Pump
SET TIME AND DATE Options or User Preferences.)
Navigation Reminders
USER PREFERENCES
Vertical movement has selected this sub-
DISPLAY PREFERENCES menu. To open it, press the Open Menu.
AUDIO PREFERENCES To close this menu, press the Back key
or any menu key.
PRINTER PREFERENCES
SET TIME AND DATE
Navigation Reminders
Open
Menu
OPEN MENU Key - Menu Navigation
AUDIO PREFERENCES
The sub-menu is now open. Functions
ALARM VOLUME 1/2/3/4/5/6/7/8 and the current settings are listed.
By default, the first function is selected.
STANDBY ADVISORY TONE Off The listing expands to show the current
BEEP VOLUME Off setting and alternatives.
The remaining functions are listed with
their current settings.
Navigation Reminders To completely exit this menu system,
either:
- Press the BACK key twice or
- Press the parent MENU key
(User Preferences) to toggle it Off
Navigation Reminders
AUDIO PREFERENCES
Moving down the list collapses the
ALARM VOLUME 8 de-selected function’s listing.
STANDBY ADVISORY TONE Off/On The new selected function listing expands
to show its alternative choices and active
BEEP VOLUME Off setting.
Navigation Reminders
AUDIO PREFERENCES
PUMP OPTIONS
Manual
Pressing the Menu Key (PUMP OPTIONS)
ECG Gain Normal
opens the menu.
Pressure Threshold * The first menu item is highlighted, and its
Internal Rate * listing is expanded.
Slow Gas Alarm ON
IAB Fill Mode AUTO Unavailable selections are marked with an
Arterial Pressure Delay asterisk (*).
R-Trac ON
Navigation Reminders
Adjustment Reminders
Pressing the OPEN MENU key opens
this adjustment menu.
UP ARROW Key - Menu Navigation
To change the parameter, Arterial
ARTERIAL PRESSURE DELAY Pressure Delay, use the menu
navigation UP and DOWN arrow keys.
Each activation increments or
decrements the parameter’s value.
Arterial Pressure 26 MSec When the desired value is reached,
Delay press the BACK key to close the
Initial Value on Opening = 22 MSec
menu and retain the setting.
For reference, the initial value of the
Adjustment Reminders parameter is recorded in the lower left
corner of the menu. This is done so
that it can be re-entered, if desired.
Semi Zero
AUTO Manual START STANDBY
Auto Pressure
Hold 2 Sec.
Pediatric Only
28 Alarm Help
Ref ECG / AP Inflation
Interval
29
Mute Line Sources
IAB
Fill Aug Open
Pump
Options
Freeze
Display
30
Alarm Menu
Hold 2 Sec.
User
Print
Preferences
Strip 31
Hold for continuous
Back
In Semi Auto and Manual Operation Mode, when the key is quickly pressed and released,
the arterial pressure delay (APD) is recalculated.
To print continuously, press and hold the key for two (2) seconds.
To stop printing, press the key again. Printing will stop after the strip has been annotated.
NOTE: Pressing the PRINT STRIP key will unfreeze the display, if
frozen.
Intelligent Counterpulsation
32
ALARM Check IAB Catheter Pressure TRIGGER
MESSAGES
20 mm Auto
0.5 mV
Threshold
ADVISORIES
Prolonged Time in Standby
33 H E A R T R AT E
Battery In Use bpm
ECG 120
34 • LEAD
II SYSTOLIC
94 mmHg
• GAIN
Normal
80 99
35 Unassisted
DIASTOLIC
PRESSURE
SOURCE
External mmHg
36 40
Unassisted 51
AUTO
0.0
IAB FILL MODE Infl. Defl.
Auto MEAN
mmHg
37
SLOW GAS
On AUG.
38
ALARM
15 mmHg
O P E R AT I O N
MODE
Auto 104 AUG. ALARM
39 mmHg
22 min in
Standby
40 I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery
NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.
33. ADVISORIES
This section of the screen displays alert, status, and prompt messages. There are two (2)
available advisory lines in this section. If more than one message is displayed, the advisories
are posted in priority order. See “Alarms, Alerts and Advisories” on page 3-4, for more
information regarding priority.
When skin leads are selected and a lead fault occurs, then the selected lead is alternately
displayed with the text Lead Fault.
When an External source is selected and a cable is not present, then the text No Cable is
displayed.
In the AUTOFILL mode, the CS100 will provide rapid start of IAB assist following a power-
up. See “Initiation of Assist” on page 2-14. Thereafter, it will automatically purge and refill
the IAB's shuttle gas at two (2) hour intervals or upon activation of the IAB Fill key.
The Manual Fill mode must be selected for Pediatric IABs. The selection of the fill mode is
made in the PUMP OPTIONS menu.
When Manual Fill is selected, automation of the fill process is inhibited. See “Manual Fill
Mode” on page 3-31. The IAB must be purged and filled manually. See “Filling Pediatric
Catheters” on page 6-5. Similarly, the automated sequence of steps, affiliated with the rapid
start feature, is not supported.
When the displayed text is Off, the advisory message Slow Gas Alarm Off is displayed
in the Advisory area. If a slow gas loss is detected while in this override state, the CS100
will continue to assist and the gas loss alarm message will be displayed along with its
associated alarm tone.
NOTE: When in the Manual Fill Mode, the Slow Gas Alarm status
display is OFF and all catheter and leak detect alarms are
suspended.
Intelligent Counterpulsation
ECG 120
• LEAD
42
II 94
SYSTOLIC
• GAIN mmHg
Normal
80 Unassisted 99
DIASTOLIC
43
PRESSURE
SOURCE
External mmHg
40
0.0
Unassisted 51
IAB FILL MODE Infl.
AUTO
Defl. 44
Auto MEAN
mmHg
SLOW GAS 45
On AUG.
ALARM
15 mmHg
O P E R AT I O N
Auto AUG. ALARM
46
MODE 104 mmHg
22 min in
Standby 47
I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery
49 48
NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.
41. TRIGGER
Trigger displays the selected trigger source used for both IABP synchronization and Heart
Rate determination. The possible display items for this field include: ECG, Pacer V, Pacer
A, Internal or Pressure. When a pressure trigger is selected, the pressure trigger
threshold (in mmHg) and threshold adjustment mode (Auto or Manual) will be displayed
along with the trigger source.
43. SYSTOLIC
Indicates peak systolic pressure in mmHg. When 1:2 or 1:3 is selected as the IAB
Frequency both the assisted and unassisted systolic pressures are displayed. They are
labeled accordingly. NO ZERO is displayed if the transducer requires zeroing. The display
is blanked if a pressure transducer is not connected or if an external source is selected and
the external cable plug is not inserted.
44. DIASTOLIC
Indicates end diastolic pressure in mmHg. When 1:2 or 1:3 is selected as the IAB
Frequency, both the assisted and unassisted diastolic pressures are displayed. They are
labeled accordingly. The display is blanked if the zero process has not been performed, if a
pressure transducer is not connected or if external source is selected and the external cable
plug is not inserted.
Pressure TRIGGER
20 mm Auto
Threshold
Assisted Systolic
H E A R T R AT E
bpm
Pressure
Unassisted
SYSTOLIC
mmHg Systolic Pressure
Unassisted 99
DIASTOLIC
mmHg
Assisted End
Unassisted 51
0.0 Diastolic Pressure
Defl.
MEAN
mmHg
Unassisted End
Diastolic Pressure
AUG.
15 mmHg
AUG. ALARM
104 mmHg
Augmented Diastolic
Pressure
NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.
45. MEAN
Indicates mean pressure in mmHg. The display is blanked if the zero process has not been
performed, if a pressure transducer is not connected or if External source is selected and
external cable plug is not inserted.
• IABP is in STANDBY
• The zero process for the transducer has not been performed
• A pressure transducer is not connected
• External source is selected and external cable plug is not inserted
52 53 54
Intelligent Counterpulsation
ADVISORIES
Prolonged Time in Standby H E A R T R AT E
Battery In Use bpm
ECG 120
51 • LEAD
II SYSTOLIC
94 mmHg
• GAIN
Normal
80 Unassisted 99
DIASTOLIC
PRESSURE
52 SOURCE
External mmHg
40
0.0
Unassisted 51
AUTO
IAB FILL MODE Infl. Defl.
Auto MEAN
mmHg
SLOW GAS
52 On AUG.
ALARM
15 mmHg
O P E R AT I O N
MODE
Auto 104 AUG. ALARM
mmHg
22 min in
Standby
55 I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery
NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.
Waveforms are plotted from left to right. The oldest data is erased and is replaced by new
data. To facilitate identification of the newest data a vertical erase bar is drawn. The newest
data is to the left of the bar and the oldest is to the right. Visually, the traces appear fixed as
a moving vertical bar moves through the traces and updates their appearance.
When in STANDBY mode, the approximate interval of assist is continuously estimated, and
shown on the display by highlighting the appropriate interval on the arterial pressure
waveform.
The assist interval is also displayed as a horizontal bar, with vertical dashed lines. The length
and placement of the horizontal line indicates the approximate timing of assist. The vertical
lines extend the interval upward, to the arterial pressure waveform.
During assist, display of Inflation Interval Highlighting is stopped. To view these markers
while assisting, continuously press the Inflation Interval key. (These markers are visible
only while the key is pressed).
Dicrotic Notch
Inflation Marker
Display of these markers is a user preference. Enable or disable display on the ECG
waveform via the USER PREFERENCES submenu.
Time in Standby (in minutes) is numerically displayed on the left side of the screen. This
display is active only when the system is in STANDBY. The timer display starts when the
system enters STANDBY mode for any reason. The timer display is cleared when assist is re-
initiated.
The audio tone affiliated with the alert will sound a double beep for 30 seconds. This audio
tone will be repeated at 15 to 20 minute intervals, and again at 2 minute intervals after the
20 minute mark (i.e., 22 minutes, 24 minutes, etc.) This will continue until the pump is
returned to assisting or the power is cycled.
60 Intelligent Counterpulsation
ADVISORIES
Prolonged Time in Standby H E A R T R AT E
Battery In Use bpm
ECG 120
LEAD
57 •
II 94
SYSTOLIC
• GAIN mmHg
Normal
80 Unassisted 99
DIASTOLIC
56 PRESSURE
SOURCE
External mmHg
40
0.0
Unassisted 51
AUTO
IAB FILL MODE Infl. Defl.
Auto MEAN
mmHg
58 SLOW GAS
On AUG.
ALARM
15 mmHg
O P E R AT I O N
Auto 104 AUG. ALARM
59 MODE mmHg
22 min in
Standby
I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery
NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.
To activate the line press the Ref Line key. Once activated, it will appear at the bottom of the
arterial pressure waveform. Use the Navigation Circle’s UP and DOWN arrow keys to
move the reference line to the desired measurement point on the waveform.
NOTE: The reference line may also be moved into the Balloon
Waveform Area. When used in the Balloon Waveform area,
the reference line color is blue and there is no pressure
annotation.
When in Semi Auto or Manual operation mode, the indicator is controlled by the IAB
INFLATION EARLIER and LATER keys. The Inflation Timing Indicator ranges from 0
to 5 for Manual operation mode, and from -4 to +4 for the Semi Auto operation mode.
When in the AUTO operational mode, the word AUTO appears at the center of the
indicator. This indicates that inflation timing is being automatically set and no operator
intervention is required.
In ECG trigger, while in the AUTO operational mode, user modification of the automatically
established deflation point is permitted but NOT required. Unlike inflation, deflation timing
practices can vary considerably and this option allows users to tailor deflation to personal or
institutional preference. The indicator is controlled by the IAB DEFLATION Earlier and
Later keys. The Deflation Timing Indicator ranges from 0 to 5 for Manual operation
mode and from -4 to +4 for the Semi Auto and AUTO operation modes.
The Deflation Timing Indicator also aids in distinguishing when the pump is operating in
R-Wave Deflation mode. This mode may be automatically activated by the pump
whenever atrial fibrillation or other unpredictable rhythm patterns are detected. Or, the
operator can manually activate R-Wave Deflation.
Manual R-Wave Deflation mode is activated by the operator moving the Deflation
Timing Indicator to its extreme right (late) position. The indicator will display “4.0” and
the advisory message R-Wave Deflate will also display. Manual activation of R-Wave
Deflation mode will always override automatic control of R-Wave Deflation.
CS100
Intelligent Counterpulsation
63
62
CAUTION: The internal batteries are charging only when the AC Mains
plug is connected to an active AC Mains source, the AC
Mains switch is ON, and the battery charging status LED is
illuminated. This charging condition must be maintained
even when the system is not in use. Note that 18 hours of
charging is required to fully charge the batteries.
63. Printer
See “Printer” on page 4-1, for detailed printing information.
64 81
80
79
65 78
66
77
67 76
75
68
74
69
73
72
82
CS100i
71
only
70
CAUTION: The internal batteries are charging only when the AC Mains
plug is connected to an active AC Mains source, the AC
Mains switch is ON, and the battery charging status LED is
illuminated. This charging condition must be maintained
even when the system is not in use. Note that 18 hours of
charging is required to fully charge the batteries.
71. RS-232
A 9-pin D-type connector provided for RS-232 serial data communication lines.
Press and hold the following key(s) while activating the power switch until the function or
mode is enabled.
2.1 Introduction
This section of the manual provides step-by-step instructions for properly operating the
CS100.
Prior to operating the equipment, the user must be familiar with the controls and functions of
the CS100 (See “Controls and Indicators” on page 1-1.) and have a thorough knowledge of
intra-aortic balloon pumping.
WARNING: Safety Disk Leak Test MUST NOT be performed when the
system IAB is connected to the patient.
1. Press and hold the IAB Fill key while switching IABP ON/OFF to ON. This switch is
located on the top right of console's front panel. Release the IAB Fill key when the
message LEAK TESTING SAFETY DISK appears in the advisory section of the screen.
NOTE: If the IAB Catheter Extender Input is not vented to air at the
start of the Safety Disk Leak Test, a double beep alarm tone
will sound and the message UNPLUG DISK OUTLET will be
displayed.
After approximately 10 seconds, a tone sounds and the message PLUG DISK OUTLET
is displayed in the advisory section of the screen.
2. Plug the IAB Catheter Extender Input on the safety disk with a dead end Luer plug
(supplied).
3. A double beep will sound at the end of the safety disk test. If the system passes the test,
the message SYSTEM TEST OK is displayed in the advisory section of the screen.
Remove dead end Luer plug.
If in doubt about the integrity of the safety disk, replace it. See “Safety Disk/Condensate
Removal Module” on page 7-8.
If the safety disk has been replaced and no leak is evident, but the screen still flashes the
message SAFETY DISK TEST FAILS, the IAB Autofill system may be malfunctioning and the
Manual fill procedure should be performed until a Service Representative can be contacted.
1. Attach the line cord, appropriate for the country of use, securely into the MAINS power
receptacle on the IABP console.
2. Plug the system line cord into a compatible grounded AC receptacle. In the U.S. use
only receptacles marked Hospital Grade. Do not use an adapter to eliminate the
plug's connection to ground. If auxiliary equipment is used with the CS100, insure that
the equipment is also properly grounded.
3. Verify the MAINS On/Off switch, located on the rear panel next to the receptacle, is
On. This switch may be left in the On position between IABP usages. This switch
enables power flow to system's power supply and battery charger circuitry.
4. Confirm AC operation by checking that the battery charging indicator is illuminated or
flashing.
See “Safety Disk Leak Test” on page 2-2, if a Safety Disk Leak Test is desired.
At power up, the system performs an electrical and pneumatic self test. When the self-check
is successful the SYSTEM TEST OK message appears in the advisory field of the display. In
the event that any electrical or pneumatic test fails, the message ELECTRICAL TEST FAILS
CODE #____ is displayed on the screen. The code number indicates which test has failed in
the system. Power cycle the system (power down for a minimum of 10 seconds) and if
message repeats, record the code # and call a Datascope Service Representative. See
“Troubleshooting” on page 3-1, for probable causes and recommended actions.
CAUTION: When the system is not in use, close the cylinder valve fully
clockwise to prevent a potential leak and the depletion of
the Helium supply.
3. Check that the message LOW HELIUM advisory is not displayed. If the LOW HELIUM
message is displayed, check Helium cylinder icon or gauge for adequate gas capacity
and check Helium cylinder attachment for leaks. Replace the cylinder if necessary. See
“Installation and Replacement of Helium Cylinder” on page 7-3.
In the case of pediatric IABs, the safety disk must be removed and replaced with an adapter.
In addition, other measures must be taken. See “Pediatrics” on page 6-1.
Direct ECG signal acquisition requires an ECG patient cable, lead wires and skin electrodes.
Use only the Datascope supplied patient cable and leads to minimize noise.
The type of skin electrode and application technique are major factors in determining the
quality of the signal obtained. Use of high quality electrodes is recommended. These are
designed to acquire an ECG with excellent baseline stability, recovery from defibrillation and
minimum artifact from patient movement.
RA LA RA LA
White Black Red Yellow
RA LA RA LA
(Chest) (Chest)
V C
Brown White
RL LL RL LL
RL LL RL LL
Green Red Black Green
FIGURE 2-1 Electrode Placement AHA FIGURE 2-2 Electrode Placement IEC
c. Plug ECG patient cable into the rear panel ECG INPUT connector.
d. Check that an ECG waveform is present on the system's display screen and that the
ECG field on the display indicates the desired lead and gain. Also confirm
triggering and that the heart rate read-out is now functional.
2. To change the ECG lead:
a. Confirm that the operation mode is either Semi Auto or Manual and confirm that
the trigger source is ECG.
b. Access the ECG/AP menu by pressing the ECG/AP Sources key. When the menu
is open, select the desired LEAD, then close the menu.
1. When acquiring the arterial pressure directly from a transducer, plug the pressure
transducer adapter cable into the rear panel pressure input connector. Verify that
DIRECT is indicated in the Pressure Source display field.
2. When using a high level pressure output from an external monitor, plug the interface
cable into the pressure monitor input jack and set the PRESSURE SOURCE to
EXTERNAL by pressing the ECG/AP Sources key. Verify pressure waveform display
and source display field.
3. To establish a monitoring site, utilize the inner lumen of the intra-aortic balloon or
introduce an arterial pressure catheter into the patient's radial artery in accordance with
standard hospital procedures. Aortic pressure monitoring is recommended for managing
patients on IABP therapy.
4. Connect catheter line, with a flushing device, to the pressure transducer.
All of the numeric pressure values at the right side of the display will show zero (±2
mmHg) when zeroing is successful.
6. Close pressure transducer vent to atmosphere. Check that the pressure waveform is
displayed and SYSTOLIC/DIASTOLIC and MEAN digital displays are functional at
this time.
NOTE: ECG gain can only be changed when the TRIGGER SOURCE is
set to ECG. In the menu, ECG gain is expressed as a
multiplier. It can be varied from 0.15 to 3.0, where 1.0 is
NORMAL.
For example, the 3.0 setting increases the trigger's sensitivity from its normal value of 120µV
to 40µV. When making changes to ECG GAIN, make sure QRS detection operates properly
by observing the flashing diamond and the Heart Rate display.
NOTE: Normal gain will handle most cases. Gain alteration should
be used ONLY if required.
See “Pump Options Menu Key” on page 1-17, for more information.
The threshold level and mode, Manual or Automatic, are posted just below the pressure
trigger source indication in the trigger source field of the display screen.
See “Pump Options Menu Key” on page 1-17, for more information.
Suspended assist is
indicated by the
intensified portion of
the displayed
waveform.
This automatic synchronization check can also be user initiated at any time by momentarily
pressing the START key while assist is active. This provides the capability to immediately re-
synchronize triggering and timing in the rare event that a loss of synchronization is observed.
When a synchronization check is initiated by pressing the START key, the timer for the next
check is automatically reset to 60 seconds.
An Irregular Trigger message is posted in the Advisory display field (upper left corner of
the screen) and an alert tone is briefly activated. This message indicates to users that the
system is compensating for an irregular rhythm by deflating somewhat earlier to avoid
interfering with systolic ejection. Consequently, users should NOT attempt to adjust the
deflation control if the patient is dysrhythmic and the Irregular Trigger advisory message
is posted. Adjustments to deflation timing could compromise trigger performance when the
patient finally resumes a regular rhythm and the system automatically reverts back to
standard timing.
If an AV sequential pacer is used, then the atrial pacing spike is ignored and the CS100
triggers on the Ventricular Spike. Subject to a heart rate limitation, the system automatically
recognizes and discriminates between V and AV pacer types. The trigger field on the display
screen will show V or AV as appropriate.
When using this setting, insure that the CS100 is reliably recognizing the pacemaker spikes.
If a ventricular pacer is used, be sure an enhanced ventricular pacer pulse is observed on
each cardiac cycle.
If an atrial-ventricular sequential pacer (AV Pacer) is in use, then two enhanced pacer pulses
must be observed. If this is not the case, select a different ECG Lead or increase ECG GAIN
until reliable detection is achieved.
A-V Interval
The system triggers on the ventricular pulse for either type of pacer, provided there is 100%
paced rhythm (i.e., no demand pacing). If the conditions for either pacer type are not met, a
trigger alarm occurs and the message CHECK PACER TIMING is displayed.
NOTE: Pacer V/A-V trigger will not function in the presence of ESU
Interference. Assist will be suspended temporarily and will
resume automatically when interference disappears. The
"TRIGGER INTERFERENCE" status message is displayed when
ESU interference is detected in the Pacer V/A-V trigger
mode.
2.2.7.5 Pacer A
This mode is only applicable to patient with an atrial pacer. In Pacer A trigger, the CS100
triggers on the patient's QRS. This trigger is recommended only if atrial pacer tails interfere
with R-Wave detection when using the ECG trigger. Fixed or demand atrial pacing can be
used in this trigger.
The internal trigger rate can be adjusted from 40 to 120 bpm, in increments of 5 bpm. The
rate is adjusted by opening the PUMP OPTIONS menu, selecting Internal Rate, and then
using the UP and DOWN arrow keys to set the desired rate.
When using this trigger source, the system will display INTERNAL in the upper right corner
of the screen. When Internal Trigger is selected, the system continues to monitor for
R-Wave activity via the ECG patient cable. If valid R-Wave activity is detected, then the
system displays the message ECG DETECTED and sounds a double beep alarm. The system
deflates the IAB when an R-Wave is detected to prevent competitively pumping with the
patient. If reliable R-Wave activity has resumed then the system should be switched back to
the ECG Trigger mode for proper timing.
WARNING: Do not remain in the internal trigger mode when the patient
is generating a cardiac output.
NOTE: Internal trigger rate can only be changed when the trigger
source is set to internal.
The choice of IAB frequency determines the manner in which the arterial pressure indices are
computed and displayed. In 1:1 mode all beats are assisted and a single assisted value is
displayed for each pressure index.
When either 1:2 or 1:3 is selected, the CS100 will separately display the peak assisted
and unassisted systolic and diastolic pressures. Figure 2-6 on page 2-12, illustrates these
pressure indices.
Augmented
Unassisted Diastolic Pressure
Systolic Pressure Assisted Systolic
Pressure
If the recorder is activated during 1:2 or 1:3 frequency, the assisted and unassisted systolic
and diastolic pressure will also be annotated on the strip.
• Use the IAB Inflation arrows until the highlighted segment of the arterial pressure trace
begins at the dicrotic notch.
To Set Initial Deflate Timing (optional in AUTO operation mode):
• Use the IAB Deflation arrows to adjust the end of the highlighted segment prior to
ventricular ejection.
Dicrotic Notch
Inflation Marker
APD is a value used by the IABP to adjust the time position of the intensified segment of the
Arterial Pressure Waveform.
In Semi Auto and Manual operation modes, the APD only effects the position of the
intensified segment of the waveform. It does not effect timing.
The initial power-up APD default setting is 40 msec. After the first few assisted beats, the
value is recomputed and updated.
To Verify the APD current setting: While pumping, press and hold the Inflation
Interval key and confirm that the intensified segment of the arterial pressure trace begins
approximately at the dicrotic notch.
Manually Entering a Value for APD: If still incorrect, APD can be manually adjusted
via the PUMP OPTIONS menu.
5. Verify that after one minute of assist, the Aug Alarm Limit determination on the
display panel is approximately 10 mmHg below the patient's diastolic augmentation
pressure.
6. If adjustment to the alarm limit is desired, press the Aug Alarm key. Then press the
adjacent UP or DOWN arrow keys in the navigation circle to adjust the alarm limit.
WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB FILL mode. Consequently, the
use of the augmentation alarm is essential when caring for
patients while operating in this mode.
NOTE: If the Autofill procedure fails to purge and fill the safety disk
properly, the message “Autofill Failure” will be displayed
and an audible alarm will be activated. Corrective action
can be obtained by pressing the HELP key. Manual Fill help
screens, as well as detailed fill illustrations are provided
should Manual Fill become necessary. See “Manual Fill
Mode” on page 3-31.
3.1 Introduction
The tables below list a number of operational symptoms and provide guidelines for the
necessary corrective action.
In the event that service is required, please contact a Datascope Service Representative.
Internal servicing should only be performed by qualified personnel.
Messages
RECOMMENDED
SYMPTOM (MESSAGE) POSSIBLE CAUSES CORRECTIVE ACTION
SYSTEM FAILURE System computer failure Contact Datascope Service
LOW VACUUM Insufficient vacuum Make sure safety disk is leak
tight. Restart System
ELECTRICAL TEST FAILS Major system failure Turn the IABP off. After 10
CODE#__ seconds power back up. If
condition persists, note the
Code number displayed and
contact Datascope Service
MAINTENANCE REQUIRED System maintenance may be Note the code number
CODE#__ required displayed and contact
Datascope Service
When an alarm message is displayed, IAB assist is suspended and a steady tone is sounded.
Alarm messages are displayed in the Alarm Messages section of the display. This display
indicates the highest priority alarm. If more than one alarm condition is present, then the
highest priority alarm is displayed. When the first alarm condition has been corrected, then
the next highest priority alarm is displayed. See the “Alarm and Advisory Table, which
follows, for priority listing.
When alert messages are displayed, IAB assist is not suspended, but corrective action is
required. Alert conditions which require immediate action cause a continuous double beep
tone to sound. Alert, Prompt and Status messages are displayed in the advisory section of the
display. There are two lines in this display. If more than two messages are sent, the two
highest priority messages are displayed. When one alert or status/prompt condition is
corrected or eliminated, then the next highest priority message is displayed. See the “Alarm
and Advisory Table”, which follows, for priority listing.
AUX messages are displayed in the bottom right corner of the screen when initial Setup or
Help screens are available.
Gas loss alarms provide surveillance for leaks which can result in gas leaving or entering the
IAB circuit. IAB Catheter Alarms detect an occlusion of the IAB catheter or extender. Gas can
be trapped in the IAB and/or safety disk depending on the timing of the occlusion with
respect to the pump cycle.
Gas Loss, including IAB Disconnect and IAB Catheter alarm operation is maintained at heart
rates up to 140 BPM*. However, one component of the Catheter Alarms, detection of gas
trapped in the safety disk, is suspended at 112 BPM to minimize nuisance alarms.
WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB FILL mode. Consequently, the
use of the augmentation alarm is essential when caring for
patients while operating in this mode.
*The cited heart rates assume that the timing controls are at nominal mid-position.
All All Alarm Electrical Test Failure of one or more electrical System is held in VENT Steady, on Attempt to clear by cycling power OFF
Fails, Code sub-system tests during system power-up mode / IAB deflated. immediately and ON.*
#___ diagnostics.
All All Alarm System Solenoid driver watchdog detected System disabled and Steady, on Attempt to clear by cycling power OFF
Failure vacuum and/or pressure solenoid safety disk is vented to immediately and ON.*
energized for approx. 2 seconds or atmosphere / IAB
vacuum valve is not activated within 2 deflated.
sec. of pressure valve or IABP processor
failure.
0070-10-0527-01
inflation period >120 msec and the IAB Fill key is pressed for two sec-
deflation period >250 msec onds and START is pressed to resume
pumping.
All All Alarm Autofill Balloon could not be automatically filled Vent / IAB deflated Steady, on Replace the Helium Tank then retry the
Failure - No because of inadequate Helium gas immediately autofill by pressing the START key, or
Helium supply. by pressing the IAB Fill key for two sec-
onds.
All All Alarm Blood Patient leak in IAB catheter resulting in Vent / IAB deflated/ Steady, on Attempt to clear by cycling power OFF
Detected blood migration back to catheter tubing. Purge valves closed immediately and ON.* If alarm persists and no
blood is present, switch to MANUAL
FILL mode.
All All Alarm Autofill Balloon could not be automatically filled Vent / IAB deflated Steady, on Retry the autofill by pressing the START
Failure as defined in performance section but, immediately key, or by pressing the IAB Fill key for
Helium supply is adequate. two
seconds, or select MANUAL FILL
mode.
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
Alarms, Alerts and Advisories
3-5
3-6
OPERA-
TION TRIGGER MESSAGE MESSAGE AUDIBLE
MODE SOURCE TYPE DISPLAYED PROBABLE CAUSE SYSTEM RESPONSE ALARM RESET
All All Alarm Rapid Gas 5 cc’s loss over 2 consecutive cycles Vent / IAB deflated Steady, on Message and Tone cleared when:
Loss (i.e., 2.5 cc’s loss beat to beat) immediately the START key is pressed, Autofill has
been initiated and pumping resumes or
the IAB Fill key is pressed for two sec-
onds and START is pressed to resume
pumping.
Alarms, Alerts and Advisories
All All Alarm IAB Disconnection at IAB or extension Vent / IAB deflated Steady, on Message and Tone cleared when:
Disconnected catheter while in the assist mode. immediately the START key is pressed, Autofill has
been initiated and pumping resumes or
the IAB Fill key is pressed for two sec-
onds and START is pressed to resume
pumping.
All All Alarm High Drive Regulated pressure from compressor Standby / IAB deflated Steady, on Resume assist by pressing the START
Pressure exceeds acceptable operating range. immediately key.
Semi All Alarm Autofill Prompts the user to Autofill the IAB. This Standby / IAB deflated Steady, on Message and Tone cleared when:
Auto or Required prompt occurs while assisting and when immediately the START key is pressed, Autofill has
Manual the current IAB Fill is Manual and the been initiated and pumping resumes or
user has switched to the Autofill mode. the IAB Fill key is pressed for two sec-
onds and START is pressed to resume
pumping.
All All Alarm Check IAB Occlusion of IAB/ extension catheter or Standby / IAB deflated Steady, on Reset by resuming assist via the START
0070-10-0527-01
Catheter unwrapped balloon. immediately key. If un-wrapped IAB is suspected, use
syringe to inflate manually, see IAB's
manual.
All All Alarm Leak in IAB Cumulative shuttle gas loss exceeds the Standby / IAB deflated Steady, on Message and Tone cleared when:
Circuit 5 cc/hr. dynamic limit, or total loss immediately the START key is pressed or the IAB Fill
exceeds 12.5 cc, relative to last Autofill key is pressed for two seconds
volume. Active only in Autofill mode followed by the START key, to resume
with IAB inflation period >150 msec and pumping.
deflation period >200 msec.
All All Alarm Low Vacuum Insufficient or no compressor vacuum. Waiting to pump / IAB Steady, on Automatically, when vacuum is restored.
deflated immediately
Semi Pacer V/ Alarm Trigger Electro-Surgical Noise (ESU) detected Waiting to pump / IAB Steady, on Automatically, when ESU interference
Auto or AV Interference while the Pacer Trigger Source is deflated after 15 sec stops. Or Manually, by de-selection of
Manual selected. delay, time the Pacer Trigger Source.
out after 15
sec
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
Auto or AV Timing >25% or an A-V pacer rate is >125 deflated after 15 sec. are met. Or manually, by de-selecting
Manual bpm. delay Pacer Trigger Source.
AUTO ECG or Alarm No Trigger Valid ECG and Arterial Pressure trigger Waiting to pump / IAB On Steady Automatically, when trigger returns.
Press do not exist or are lost while in AUTO deflated after 15 sec.
operation mode. delay
Semi ECG or Alarm No Trigger Valid trigger, as defined in Specification Waiting to pump / IAB On steady Automatically, when trigger returns.
Auto or Pacer A Section, does not exist or is lost while in deflated after 15 sec.
Manual or Pacer ECG or Pacer Trigger mode. delay**
V/AV
0070-10-0527-01
Detected blood migration back to fill tubing while Purge valves closed immediately and ON.*
in Manual Fill.
AUTO All except Alert No Trigger No valid trigger has existed since the Standby / IAB is None Automatically, when a valid trigger is
Internal IABP was powered up in AUTO deflated detected.
operation mode.
Semi All except Alert No Trigger No valid trigger has existed since the Standby / IAB is None Automatically, when a valid trigger is
Auto or Internal IABP was powered up in Semi Auto or deflated detected.
Manual Manual operation mode.
Semi Internal Alert ECG ECG activity is detected persistently for Assisting / IAB is Continuous Automatically, when ECG activity
Auto or Detected 4-6 seconds while in the Internal immediately deflated double beep ceases. Manually, by de-selecting
Manual Trigger mode. on each R-wave Internal Trigger mode.
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
Alarms, Alerts and Advisories
3-7
3-8
OPERA-
TION TRIGGER MESSAGE MESSAGE AUDIBLE
MODE SOURCE TYPE DISPLAYED PROBABLE CAUSE SYSTEM RESPONSE ALARM RESET
Semi Pressure Alert Irregular While Pressure is the Trigger System automatically After 60 Automatically, when trigger interval is
Auto Pressure Source, erratic trigger is due to: bases deflation on second regular.
Trigger 1 Arrhythmic patient rhythm shorter cardiac delay,
2 Late deflation; inhibiting pressure intervals. double
pulse detection beep.
Sounds for
Alarms, Alerts and Advisories
2-3 seconds
and repeats
every 5 min.
AUTO ECG Alert Poor Signal Both ECG and Arterial Pressure signal System automatically Double Automatic upon detection of a good
Quality quality is poor while in ECG trigger. bases inflation on Beep for 3 input signal.
shorter cardiac seconds,
intervals. repeats
every
minute
AUTO ECG or Alert No Pressure Neither a direct or external blood System automatically Double Automatically, upon connection of a
Pressure Source pressure source was detected. bases inflation on Beep for 3 viable pressure source.
Available shorter cardiac seconds,
intervals. repeats
every
minute
0070-10-0527-01
AUTO ECG or Alert Unable to Waveform quality is poor. System increases Double Automatic upon completion of a
Pressure Update 1 One or more waveform features frequency of attempts Beep for 5 successful update.
Timing needed to update. Timing can not be to update seconds,
identified. repeats
2 The sustained heart rate is less than every
30 BPM or greater than150 BPM. minute
3 Poor Augmentation
All All Alert Augmenta- Diastolic augmentation has dropped Unaffected Continuous Automatically, when augmentation rises
tion Below below the user selected limit. double beep above alarm limit.
Limit Set
All All Alert Low Battery Battery reserve falls below 30 minutes of Unaffected Double Automatically removes message and
operating time. beep - times turns off tone when AC is restored.
out after 30
seconds.
Repeats
every 10
minutes.
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
(EXT) utes of operating time. beep - times off tone, transfer to internal battery
(CS100i out after 30 occurs.
only) seconds.
Repeats
every 10
minutes.
All All Alert Maintenance System maintenance may be required. Unaffected Double Attempt to clear by cycling power OFF
Required beep - times and ON.*
Code # ___ out after 30
0070-10-0527-01
out after 30
seconds,
repeats at
15 and 20
minutes,
and every 2
minutes
thereafter.
Manual All Alert Manual The operator selected Manual Unaffected None Automatically when the operator selects
Timing operation mode. another operation mode or presses the
selected - see START key.
Help
Semi All Alert Verify proper The operator selected Semi Auto Unaffected None Automatically when the operator selects
Auto Timing operation mode. another operation mode or presses the
START key.
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
Alarms, Alerts and Advisories
3-9
OPERA-
3 - 10
TION TRIGGER MESSAGE MESSAGE AUDIBLE
MODE SOURCE TYPE DISPLAYED PROBABLE CAUSE SYSTEM RESPONSE ALARM RESET
All All Prompt Low Vacuum There is no Safety Disk attached to the Waiting to pump / IAB Double Automatically when Safety Disk is
system. deflated beep, attached to the system.
immediately
All All Prompt Unplug Disk Prompts user at start of Safety Disk Leak Safety Disk Diagnostic Double Manual, press the IAB Fill key for two
Outlet Diagnostics to open the safety disk’s Mode / IAB is NOT beep, seconds to resume testing.
catheter connector so that atmospheric connected immediately
Alarms, Alerts and Advisories
0070-10-0527-01
Semi All Prompt Manual Fill Notifies the operator when to manually Fill Mode (Safety Disk None Press the IAB Fill key for two seconds.s
Auto or IAB fill the IAB catheter with shuttle gas. Drive Vented) / IAB
Manual Displayed in MANUAL FILL mode when deflated
the IAB Fill key is activated, venting the
safety disk.
All All Status Leak Testing Displayed during the safety Disk Leak Safety Disk Diagnostic None N/A
Safety Disk Diagnostic to indicate that testing is still Mode / IAB is not
in progress. connected
All All Status Autofilling Indicates that the System is in the process Autofill Mode / IAB None Message clears when autofill completes.
of Automatically purging and refilling the deflated
IAB with Helium.
Semi All Status Automatic System is set to Manual Fill mode and Unaffected. AUTO None Message clears after 30 seconds or
Auto or Operation the operator tries to select AUTO opera- operation mode is upon user selection of Autofill mode.
Manual Mode is tion mode. disabled.
disabled
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
Auto or Catheter abled when manual fill mode is selected Fill mode.
Manual Alarms (IAB catheter is manually filled).
Disabled
All All Status Slow Gas Slow gas loss alarm has been disabled Unaffected None Message clears when slow gas loss
Loss Alarm is by the user. NOTE: Rapid loss func- alarm is re-enabled.
Off tion is still active.
Auto All Status Function Displayed when the operator presses an Unaffected. No action None Message automatically clears after 3
unavailable unavailable key while in the AUTO in response to pressing seconds.
in AUTO operation mode. unavailable keys.
0070-10-0527-01
OK tics. seconds after completion of the tests.
All All Status System Displayed when the System Trainer is Unaffected None Message clears when System Trainer is
Trainer being used as ECG and Pressure source. removed.
Auto or ECG in Status Auto R-Wave R-Trac is ON and the patient’s rhythm is Pumping Unaffected - None Status automatically clears when patient
Semi Auto Deflate too random to predict the occurrence of The system is now rhythm becomes predictable.
Auto or the next beat. using R-wave deflation
ECG or A “R-Trac” in In response, the system has automatically instead of the current Disabled by setting R-Trac to OFF in the
Pacer in IAB Deflation selected R-Wave Deflation Mode. deflation setting. PUMP OPTIONS menu.
Semi Auto Indicator
Auto or ECG in Status R-Wave Operator has enabled Unaffected -Deflation None Move deflation slider away from
Semi Auto Deflate R-wave deflation by moving deflate begins on extreme right position.
Auto or slider to extreme right position. R-wave detection.
ECG or A “4.0” in
Pacer in IAB Deflation
Semi Auto Indicator
* When cycling power, turn unit OFF for 10 seconds before turning back on.
** The audible alarm will be suppressed if a valid heart rate has not been detected since the pump was turned on.
Alarms, Alerts and Advisories
3 - 11
OPERA-
3 - 12
TION TRIGGER MESSAGE MESSAGE AUDIBLE
MODE SOURCE TYPE DISPLAYED PROBABLE CAUSE SYSTEM RESPONSE ALARM RESET
All All Auxiliary Help Displayed at power-up until the first Unaffected None Automatically, message clears with first
Available for pump cycle. pump cycle.
Initial Setup
Semi All Auxiliary Help Displayed when the user selects Unaffected None Automatically, message clears when
Auto or Available for Manual Fill. There is no advisory autofill is selected.
Manual Manual Fill message displayed. Only an auxiliary
Alarms, Alerts and Advisories
0070-10-0527-01
CS100™/CS100i™ Operating Instructions
Troubleshooting
Troubleshooting Help Screens
1. Press the HELP key on the keypad. The key's LED illuminates. The HELP screen window
replaces the balloon waveform.
2. In the HELP window, use the NEXT PAGE or PREVIOUS PAGE keys to page through
the available screens. Pressing the NEXT PAGE key displays the next available page of
help screen information. Pressing the PREVIOUS PAGE key displays the previous page
of information. If the NEXT PAGE or PREVIOUS PAGE keys are pressed, and
additional pages are not available, then the same page is displayed again.
3. Press the HELP key again or the BACK key to return the screen to the normal waveform
display.
For reference, the following pages show all of the available alarm and set-up help screens.
The patient's pulse pressure 1. Attempt to restore A.P. pulse height by flushing
is inadequate for pressure the fluid circuit.
triggering.
R-wave voltage is very low. 1. Switch operation mode to SEMI AUTO and
increase ECG Gain setting in the PUMP
OPTIONS menu.
2. Use IAB Inflation and IAB Deflation controls to
adjust timing and resume pumping by
pressing the START key.
No Trigger An electrode is detached or 1. Reattach or reposition the electrodes.
malpositioned.
An incorrect trigger source 1. Select a different trigger source using the
has been selected. TRIGGER SOURCE arrow keys. Resume
pumping by pressing the START key.
There is inadequate signal 1. Try ECG lead selections via the ECG/AP
acquisition. Sources menu, or select EXT. ECG, if
appropriate.
2. Adjust the ECG Gain by accessing the PUMP
OPTIONS menu.
1. Remove the autofill tubing from the IAB Fill Port on the Safety Disk.
2. Attach a three-way stopcock to the IAB Fill Port on the Safety Disk.
4. If the IAB Fill LED is not illuminated then press and hold the IAB Fill key for two seconds to activate it
and relieve vacuum.
5. Open the stopcock between the disk and syringe. Evacuate the disk by pulling back on the syringe
plunger.
7. Repeat steps 5 and 6 until strong resistance is noted. A strong resistance should be noted within three
attempts. If a strong resistance is noted, proceed to step 9.
8. If a strong resistance is not noted within three attempts, remove the Drain port tubing and attach the
Drain port plug, located in the manual fill accessory kit, to the Drain port. Repeat steps 5 through 7.
NOTE: All Datascope adult size IAB Catheters have a manual fill pre-load of 80 cc.
When using catheters from another manufacturer consult manufacturer for
guidelines.
9. Attach the syringe to the manual fill port located below the Safety Disk.
12. Holding the syringe tip down, attach the syringe to the stopcock on the Safety Disk, and open the
stopcock to the disk.
13. Press the IAB Fill key for two seconds to allow the syringe contents to be drawn into the disk.
15. Refill the syringe with the remaining 40 cc pre-load of Helium from the manual fill port.
16. Holding the syringe tip down, attach the syringe to the stopcock on the Safety Disk.
17. Open the stopcock to the Safety Disk. The remaining 40 cc of gas is drawn into the disk.
1. Set the operation mode to Manual and then set IAB FILL MODE to Manual via the PUMP OPTIONS
menu.
2. Refer to the pediatric balloon catheter instructions for the correct Safety Chamber size, pre-load volume
and extender.
3. On the Safety Disk, remove the autofill tubing from the IAB Fill Port, the drain tubing from the Drain Port,
and the D.C. output cable.
4. Remove the Adult Safety Disk from the IABP. Install the pediatric adapter, drive hose and the appropriate
size Safety Chamber as directed in the Operator manual.
5. Attach a three way stopcock to the IAB Fill Port on the Safety Chamber.
8. If the IAB Fill LED is not illuminated then press and hold the IAB Fill key for two seconds to activate it
and relieve vacuum.
9. Open the stopcock between the chamber and syringe. Evacuate the chamber by pulling back on the
syringe plunger.
12. Attach a 20 cc syringe to the manual fill port located below the Safety Disk.
14. Fill the syringe with the correct pre-load volume of Helium as outlined in the catheter instructions. If the
pre-load volume exceeds 20 cc, fill the syringe with half of the appropriate pre-load volume.
15. Holding the syringe tip down, attach the syringe to the stopcock on the Safety Chamber, and open the
stopcock to the chamber.
16. Press the IAB Fill key for two seconds to allow the syringe contents to be drawn into the chamber. Close
the stopcock and remove the syringe.
17. If the pre-load volume exceeded 20 cc, add the remaining pre-load volume by repeating steps 14
through 15.
AUTO Operation AUTO Operation Mode 1. Open PUMP OPTIONS menu, and set the
Mode is Disabled requires that IAB FILL MODE IAB FILL MODE to AUTO.
be set to AUTO. 2. If the autofill mode is desired, then, press the
START key to refill the IAB and resume
pumping.
Battery In Use The IABP is being powered 1. Verify that it is necessary to operate from the
from the internal batteries. internal battery. If appropriate, switch to the
AC power source.
2. Verify MAINS power switch, located above
the AC power cord connector, is ON.
Battery In Use (EXT) The IABP is being powered 1. Verify that it is necessary to operate from an
(CS100i only) from an external (Battery or external power source. If appropriate, switch
to the AC power source.
DC) power source.
2. Verify MAINS power switch, located above
the AC power cord connector, is ON.
Auto R-Wave Deflate The patient's rhythm is too 1. DO NOT adjust the deflation setting. The
random to predict the next System will return to that setting once the
rhythm becomes predictable.
beat. The System is now
using R-wave deflation 2. If you do not want the System to override the
deflation setting, set R-Trac to OFF via the
instead of the current PUMP OPTIONS menu.
deflation setting.
INITIAL SET UP
6. Attach the IAB catheter and the appropriate extender to the safety disk.
7. To initiate pumping, press the START key. In response the IABP will Autofill. Once the Autofilling
message clears, pumping will begin. If desired, IAB DEFLATION timing can be fine tuned via the use of
the IAB DEFLATION controls.
• Verify that the AUG. Alarm setting is approximately 10 mmHg less than the patient's diastolic
augmented pressure
• If needed, adjust by pressing the Aug Alarm key and using the navigation arrow keys to change the
value displayed on the screen
3.4 Clinical
3.4.1 Water Condensation
During balloon pumping, a fine mist or small droplets of water may occasionally be
observed within the IAB extension catheter and/or fill and drain tubing. This mist is
condensed water. The CS100 has a condensate removal module which automatically
collects and removes condensate without operator intervention.
If desired, the following procedure may be used to manually check and purge any
condensate which may have collected in the IAB extension catheter.
1. In the Semi Auto operation mode, set the IAB FILL MODE to Manual, via the
PUMP OPTIONS menu.
2. Disconnect patient balloon catheter extender from patient IAB. Tip the catheter extender
downward.
3. Press the START key.
4. Pump for approximately 20 to 30 seconds. Water will be expelled.
5. Stop assist by pressing the STANDBY key. Reconnect the IAB catheter extender to
patient IAB.
6. Via the PUMP OPTIONS menu, set the IAB FILL MODE to Auto.
7. Return to AUTO operation, if appropriate.
8. Press the START key to autofill the IAB and resume assist.
NOTE: When in the Manual Fill mode or when the battery is low,
the condensate removal module is disabled to conserve
power.
Pressure: Flush arterial line at regular intervals per standard hospital procedure.
Adequate flushing to maintain pressure line patency and alignment of
stopcock in the proper position will prevent the majority of possible
pressure trace problems.
Atrial Ensure that the R-Trac option is not disabled. In AUTO operation mode,
Fibrillation: there are no special pump considerations for handling atrial fibrillation.
In Semi Auto operation mode, use ECG Trigger. This will track ran-
dom rhythm most consistently, by automatically holding the IAB inflated
until the detection of the next R-Wave. Pressure triggering is not recom-
mended in atrial fibrillation.
Triggering on Ectopics: The CS100 automatically deflates on and assists the ectopic beat, if
the ectopic R-wave is sensed. In Semi Auto operation mode, if the
ectopic beat is of small amplitude, reliable triggering can be maxi-
mized if an ECG Lead is selected which minimizes the amplitude differ-
ence between the normal QRS complex and that of the ectopic beat.
No special adjustments are necessary.
Cardiac Arrest- When defibrillating the patient, the CS100 has protection and is com-
Ventricular Fibrillation: pletely isolated from the patient and the defibrillator's electrodes. How-
ever, the operator should stand clear of the pump during defibrillation.
This is particularly important when the CS100 is operated while dis-
connected from an earth grounding point, such as the A.C. power
receptacle.
Ventricular Standstill If possible, use ECG or Arterial Pressure trigger during CPR. This
or Prolonged Cardiac facilitates synchronization of the assist to the rate and rhythm of chest
Arrest: compressions.
If neither the ECG nor the Arterial Pressure signals produce ade-
quate trigger reliability to allow for AUTO Operation, the IABP may be
triggered by its own internal clock. Select the Semi Auto operation
mode and set the Trigger Source to Internal. The default internal
rate is 80 bpm but can be varied between 40 and 120 bpm by access-
ing the PUMP OPTIONS menu and setting the Internal Rate.
Change in Pressure If patient's pressure monitoring site is changed while assisting in Semi
Monitoring Site: Auto or Manual operation mode, the Inflation Interval key can
be quickly pressed and released to recalculate arterial pressure trans-
mission delay (APD). This will assure accurate digital pressure display
values and arterial pressure trace inflation interval markers.
Patient Risk Currents: Simultaneous connection of several medical devices to the patient may
cause summation of leakage currents which can exceed the values
allowed by the Safety Agency Standards. See “Agency Compliance”
on page 11-22.
Limiting the power of this noise energy is desirable. The magnitude of interference is directly
related to the power setting of the ESU, which should be as low as possible for the intended
effect. Successful ECG triggering in the presence of ESU noise depends, to a large extent, on
proper patient preparation and ESU use.
Following the guidelines listed will minimize the amount of energy coupled from the ESU to
the ECG input of the CS100, generally resulting in stable ECG triggering. When the CS100
is in AUTO operation mode, it will automatically select Pressure Trigger when ESU
interference is detected and return to ECG a short interval after interference ceases. If the
clinician prefers to stay in Pressure Trigger during the operating room procedure, this can
be accomplished by selecting Semi Auto operation mode. Then select Pressure Trigger
Source. Return to AUTO operation mode when appropriate.
When the CS100 is used in an electrosurgical environment, the following techniques are
recommended to minimize interference from electrosurgical devices:
• Always use supplied Datascope Operating Room ECG patient cable and lead wire
option. See “ECG Patient Cables” on page 10-6, for more information. These cables are
shielded and incorporate ESU suppression components
• Keep the ECG cables at right angles to the electrosurgical cables to the greatest extent
possible
• Locate the ECG electrodes as far away from the surgical site as possible
• Locate the ECG electrodes approximately equidistant from the surgical site to minimize
any difference in potential between electrodes
• Place all ECG electrodes on the same plane (either anterior or posterior) to minimize any
difference in potential between electrodes
• Place the electrosurgical return plate directly under the surgical site
• Use the minimum required electrosurgical setting
While the patient is on full bypass, either Semi Auto or Manual operation mode can be
used. The Inflation and Deflation controls should be set to mid position.
If ECG activity is detected while in the internal trigger mode, the IAB will be immediately
deflated to avoid asynchronous pumping and resultant interference with systole.
WARNING: Do not remain in the internal trigger mode when the patient
is generating a cardiac output.
When weaning a patient from cardiopulmonary bypass, the IABP can be used to assist
cardiac function. If ECG is established it can be used to trigger the system. Check to see if a
reliable ECG trigger is present by noting a flashing diamond in the upper right corner of the
display. The diamond should flash one time for each R-Wave.
If the patient's ECG amplitude is insufficient to cause triggering, select the Semi Auto or
Manual operation mode. Then adjust ECG Gain to increase its amplitude, via the PUMP
OPTIONS menu. If a pacer is present, the appropriate pacer trigger mode can also be
used. Pressure triggering is also available if a 7 mmHg minimum pulse pressure is present.
As bypass flow rate is decreased and the heart begins to generate a cardiac output, check
that timing is correct. Frequent reassessment may be necessary as changes in patient
condition may alter the relationships between electromechanical events.
WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB FILL mode. Consequently, the
use of the augmentation alarm is essential when caring for
patients while operating in this mode.
OFF
three attempts. If a strong resistance is noted,
proceed to step 10. OFF
OPENED CLOSED
14. Press the IAB Fill key for 2 seconds to allow the
syringe contents to be drawn into the disk.
If desired, printing can be initiated automatically due to an alarm event or at a fixed interval
selected by the user. The initiation, format and length of the printout will adhere to the
settings in the PRINTER PREFERENCES submenu of the USER PREFERENCES menu.
The speed of printing (25 or 50 mm/sec) is controlled by the Sweep Speed setting in the
DISPLAY PREFERENCES submenu of the USER PREFERENCES menu. See “Menu Group
Keys” on page 1-14.
The dual trace chart recorder provides a hard copy record of patient waveforms. Printouts
follow the format defined by the settings in the PRINTER PREFERENCES submenu, located
in the USER PREFERENCES menu. Dual or single trace formats may be selected. Waveform
choices are: ECG, Arterial Pressure and Balloon Pressure Waveforms.
ECG: A delayed ECG waveform will be recorded for the length specified in the
printer configuration menu. Numeric information for Lead selection and
Size is printed at the beginning of the trace. If either are changed the
numeric information is reprinted.
Trigger
Markers
Inflation
Interval
Arterial Pressure: A delayed invasive arterial pressure waveform will be recorded for the
length specified in the printer configuration menu. Scale information is
annotated at the beginning of the trace. If the pressure scale changes the
annotation is automatically repeated.
Shows
Indica the
que la end of Congelar
función the graphpantalla se ha cancelado
Balloon Waveform: A delayed balloon pressure waveform will be recorded for the length
specified in the printer configuration menu.
Dual Waveforms: Two of the three possible waveforms, ECG, Arterial Pressure and Balloon
Waveform may be recorded simultaneously for the length specified in the
printer configuration menu. Waveforms will be printed as in the exam-
ples below. Annotations will be as described previously for single wave-
form recordings.
13
13
See FIGURE 4-7, for samples of these trailer formats. The date and time of the recording is
automatically printed by the CS100. The Patient I.D. is left blank and can be filled in
manually.
Alarm and Advisory Messages Alarm and Advisory Messages Alarm and Advisory Messages
Alarm and Advisory Messages Alarm and Advisory Messages Alarm and Advisory Messages
Alarm and Advisory Messages Alarm and Advisory Messages Alarm and Advisory Messages
OPERATION MODE: Auto OPERATION MODE: Semi Auto OPERATION MODE: Manual
UNASSISTED
Printout for IAB Frequency 1:1 Printout for Standby Mode
Syst/Dias: 117/52
MEAN: 79
It is recommended that all four casters are locked FIGURE 5-1 CS100 Console on
a Hospital Cart
for use on uneven surfaces or in transport
vehicles.
The Battery In Use status message and the Battery Indicator are displayed when the
CS100 is operating from the internal rechargeable battery. When the battery has
approximately 30 minutes of operating time remaining, the following occurs:
1. Leave the system power cord plugged in and set the MAINS On/Off to ON.
2. Check that the Battery Charging LED is illuminated (continuously or flashing depending
on state).
3. Allow a minimum of 18 hours to fully charge a low battery.
4. A fully-charged new internal battery will provide at least 135 minutes of portable
operation.
NOTE: A reduction in run time will occur over a battery's life due to
age, storage temperature and discharge depth. Batteries
which are continually subjected to complete discharge cycles
without the recommended immediate recharging, can incur
permanent damage. See “User Maintenance” on page 7-1,
for additional information.
4. When AC power is restored the system automatically reverts from internal battery
operation to AC Mains usage. The internal battery pack will resume charging while the
system operates from AC Mains power. Always verify that the Battery Charging LED is
continuously illuminated or flashing.
Specifications for DC Source and Inverter For Use with the CS100
Voltage Output: 100-120/220-240 VAC ±10%
Frequency: 50 Hz ±2 Hz, 60 Hz ±2 Hz
Output Capability: Minimum of 500 watts continuous power; 1000 watts surge power
See “Operation Instructions” on page 2-2. The operating sequence is the same as described
in this section, except that AC power is obtained from the inverter output connector.
For proper operation during air transport, the CS100 balloon pressure must adapt to local
atmospheric pressure. In the Autofill mode the system will automatically purge and fill the
IAB when local atmospheric pressure decreases or increases by 25 or 50 mmHg,
respectively. These pressure changes occur approximately every 1,000 feet of rise or 2,000
feet of drop in altitude.
WARNING: The Autofill mode should be used during air transport. If the
Autofill mode cannot be used and the Manual Fill mode is
required, ensure that a manual fill is performed at each
interval and altitude that an Autofill would occur.
CAUTION: Insure that the wheels of the cart are in the locked position
when removing the pump console from the cart or returning
the pump console to the cart.
Levers
4. To release the battery pack from the cart, pull the Lift from here
console release handle located just below the
battery pack (see figure 5-3). Use both hands to IABP OFF
CS100
ON
PUSH HERE
TO OPEN
Release
button
PUSH
TO HER
OPEN E
• The UTS IABP features larger wheels than the cart-configured IABP. This allows for ease of
movement over rough, uneven surfaces.
• The UTS IABP has a retractable handle, used for pulling the IABP while in transport
• The UTS IABP includes a soft-sided storage bag for accessories such as the Doppler, ECG
cables and lead wires.
• The UTS IABP has pockets and handles to ease lifting into vehicles, helicopters or fixed
wing aircraft.
Handles
CAUTION: Lifting the IABP by the Lower Lift Handles requires two
people. While lifting, the IABP must be steadied by placing a
free hand near the top of the unit to provide stability.
5.3.1 Use of the Light Weight Docking Station (P/N 0436-00-0110) and
Mobilizer
The UTS IABP mounts onto a docking station (Datascope accessory) for transport use in an
emergency vehicle, helicopter or fixed wing aircraft.
Ensure that the docking station has been properly secured to the transport vehicle deck. (see
instruction sheet enclosed with the docking station).
1. Position swing bolts as shown in figure below and red knobs are fully backed out (turn
the red knobs counter-clockwise).
FIGURE 5-9
2. Place the System in front of the docking station and center it. Roll the System into place
using the sides of the docking station as guides.
CS10
Inte 0
lligent
Co unt erp
ulsatio
n
Handle
SIDE VIEW
The UTS IABP mounts onto a docking station (Datascope accessory) for transport use in an
emergency vehicle, helicopter or fixed wing aircraft.
3. Without tilting the System, ensure the conical pins have been fully engaged by the
conical holes on the mobilizer.
IABP OFF ON
Gap
SIDE VIEW (PARTIAL CUT AWAY)
FIGURE 5-11
4. Move the swing bolts into position as shown in FIGURE 5-9. Turn the red knobs
clockwise until gaps are fully closed and a sudden increase in resistance is felt.
Red
Knobs
FIGURE 5-12
5. Check the function of the docking station by rocking the top of the System in all
directions. No motion between the mobilizer and the docking station should be
apparent.
The drive system of the CS100 is modified for pediatric use by replacing the safety disk with
the pediatric adapter assembly (P/N 0998-00-0110-01). This adapter extends the drive
pressure line allowing remote placement of the safety chamber isolator by the patient's side.
This is required to keep pediatric IAB catheter length short. Note that the 4 and 6 ft.
extension catheters are used only with adult balloons.
CAUTION: When the system is not in use, close the cylinder valve fully
clockwise to prevent a potential leak and the depletion of
the Helium supply.
2. Attach Pediatric IAB catheter to the safety chamber now or after acquisition of ECG and
pressure signals.
On the inflate control scale, 0 represents inflation at the trigger event with each increment
representing a 125 msec delay. On the deflate control scale, 0 represents deflation
immediately after inflation with each increment representing a 125 msec delay.
If inflation is adjusted, deflation is directly effected and will also require re-adjusting. If a
trigger event is detected prior to the IAB deflation point, a safeguard will automatically
deflate the IAB at the trigger event.
NOTE: If this is not the case, set the IAB FILL MODE to Manual via
the PUMP OPTIONS menu.
2. Attach a 3-way stopcock to the side port Luer fitting on the chamber.
3. Press the IAB FILL key for 2 seconds. Screen will display Manual Fill IAB message.
4. Check that the Helium gauge indicates sufficient gas pressure.
OPENED CLOSED
14. Hold the syringe tip down and/or cover with your
finger. Attach the filled syringe to the stopcock on
the safety chamber and open the stopcock
between the safety chamber and the syringe. OFF
CAUTION: When in Manual Fill Mode, the IAB should be re-filled every
2 hours when using adult IABs and every 45 minutes when
using pediatric IABs.
3. Use the IAB AUGMENTATION UP arrow key to slowly increase the level until IAB
augmentation is at maximum.
4. If necessary, adjust the IAB INFLATION and IAB DEFLATION controls to achieve
proper timing. Augmentation should begin at the dicrotic notch.
5. While pumping, press and hold the Inflation Interval key to confirm that the marked
and intensified segment of the arterial pressure trace begins approximately at the
dicrotic notch.
6. If not, the Arterial Pressure transmission delay (APD) can be automatically recalculated
by quickly pressing and releasing the Inflation Interval key.
7. Confirm proper intensification position on the AP waveform.
8. If still incorrect, APD can be manually adjusted by accessing the Arterial Pressure
Delay submenu in the PUMP OPTIONS menu.
9. Once APD is selected, the delay may be adjusted from 0 to 180 msec. in 4 msec.
increments using the UP and DOWN arrow keys. The marked and intensified segment
of the arterial pressure waveform will consequently move later on the trace. This delay is
adjusted to approximate the start of intensification at the dicrotic notch.
10. Confirm that the Aug Alarm is ON and the limit is set approximately 10 mmHg below
diastolic augmentation.
WARNING: When the CS100 is operated in the Manual Fill mode, the
IAB Catheter and Gas Loss Alarms are disabled. The
message “Gas Loss and Catheter Alarms Disabled” will be
displayed in the Advisory section of the display. The IAB
status bar will not be active. Therefore, use of the Low
Augmentation Alarm is essential in pediatric IAB patient
care. By setting the Low Augmentation Alarm, the system
monitors the level of assist and alerts the user in the event
that diastolic augmentation has dropped below the alarm
limit.
7.1 Introduction
This section of the manual outlines routine maintenance which should be performed by the
user or qualified personnel. Guidelines for correcting certain problems are also provided.
Some system problems may require the user to contact a Datascope Service Representative.
The Helium cylinder should be replaced when pressure drops below a preset level. This is
indicated when the LOW HELIUM message is displayed during operation and/or when the
Helium pressure gauge shows that the Helium supply is in the red zone. There is no need to
interrupt IABP. However, the cylinder should be replaced as soon as possible to avoid a
potential Autofill failure which can delay pumping.
To replace cylinder:
Cylinder
Valve
Cylinder
Yoke
Cylinder
Screw
If your usual medical supplier cannot refill cylinders with medical grade Helium, consult the
following suggested sources. Any phone or fax numbers that have been provided may have
changed. Please check your local directory for current phone numbers. Also, the Customer
Service Representative at the Regional Sales Office nearest your location can supply the
name of a local distributor who can provide this cylinder gas product.
The safety disk and condensate removal module are combined into one assembly. The
assembly is located on the rear of the CS100.
NOTE: This test should be performed when the system is not in use.
It may be necessary to fill the system more than once before
the “LOW HELIUM” message is displayed.
7.8 Batteries
This section of the manual provides information about the batteries used in the CS100. The
CS100 includes a battery pack which contains two sealed lead acid batteries. A basic
understanding of the proper care and handling of these batteries is essential for safe and
effective battery operation of the CS100.
The batteries are maintenance free. There is no need to add water or electrolyte. The
batteries are sealed to prevent leakage from the terminals or case. Batteries should be
replaced after 100 full discharge cycles, at no more than three (3) year intervals, or if run
time is less than 120 minutes. This recommendation is based upon general experience,
consideration of the typical number of charge/discharge cycles an average battery will be
subjected to over the period, and the number of charge/discharge cycles available from the
battery as well as its application.
This battery type may be subject to local regulations regarding disposal. At the end of the
battery life, dispose of the battery in accordance with any local regulations.
To obtain optimum battery performance and expected battery life the following guidelines
should be observed.
1. The batteries should be maintained at full charge when the CS100 is not in use. It is
required that the CS100 be plugged into an AC outlet when the system is not in use.
Verify the battery is charging by observing the charge indicator on the pump module. If
the unit must be stored for an extended time period (2 months or longer) and AC power
is not available to maintain the internal battery, disconnect the system battery pack from
the system console. Due to battery self-discharge the disconnected batteries must be fully
recharged at least every four months.
2. The battery contains a safety vent that will allow gases to be released should its rating
be exceeded. If this vent is actuated do not operate the unit and contact a qualified
service representative.
3. Over discharging, or draining the battery beyond its capacity, is generally not practical
and will shorten battery life or damage the battery. Therefore, when the IABP is not in
use and the system is not plugged into an AC source, avoid attachment of the battery
pack to the system console.
4. Do not short circuit the battery or battery pack terminals. Keep battery pack covers on at
all times to avoid objects or liquids falling on batteries. Excessive heat is very
detrimental to battery life. Avoid placing the battery or instrument containing the battery
in close proximity to heat sources of any kind.
5. DO NOT attempt to repair the battery. If the case is cracked or terminal leads are
broken replace with the same rate battery.
6. DO NOT disassemble battery. The battery contains an electrolyte which can injure skin
or damage clothing. In the event that electrolyte gets on skin or in eyes, immediately
flush with water for 15 minutes and get prompt medical attention.
7. Battery back up system should be checked before or after each use. Batteries should be
replaced after 100 full discharge cycles, at no more than 3 year intervals, or if run time
is less than 120 minutes.
Schedule A indicates which actions should be taken by either the Clinical User or by a
Biomedical Technician (BMET). These steps do not require the use of tools and may be
performed in a clinical setting.
Schedule B indicates the actions which should be performed only by a BMET or other
qualified service personnel. Tools are required and in some cases the instrument covers must
be removed.
Schedule A
To be performed by the clinical user or the BMET.
INTERVAL
Schedule B
To be performed by the BMET.
INTERVAL
7.10 Warranty
Datascope Corp. warrants that its products will be free from defects in workmanship and
materials for a period of one year from the date of purchase except that (1) disposable or
one-use products are warranted to be free from defects in workmanship and materials up to
a date one year from the date of purchase or the date of first use, whichever is sooner (2)
compressor pump heads, diaphragms, mufflers, motor brushes, and pneumatic filters are
consumed in the course of normal use and are not warranted.
The sealed lead-acid battery is also warranted to be free from defects in materials and
workmanship for a period of one year from the date of purchase.
Safety disks are warranted for two years from the date of installation, 1000 hours of use or
expiration date, whichever comes first.
Recommended preventive maintenance is the responsibility of the user, for which parts and
labor are not included under this warranty.
Datascope Corp. shall not be liable for any incidental, special, or consequential loss,
damage or expense directly or indirectly arising from the use of its products, liability under
this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or
replacing at Datascope Corp’s option at the factory or at an authorized Datascope
distributor, any product which shall under normal use and service appear to the Company to
have been defective in material or workmanship.
This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty of merchantability or fitness, and of any other obligation on the part of the
seller.
Damage to any product or parts through misuse, neglect, accident or by affixing any non-
standard accessory attachments or by any customer modification voids this warranty.
Datascope Corp. makes no warranty whatever in regard to trade accessories, such being
subject to the warranty of their respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Datascope, freight prepaid to Datascope
Corp., Mahwah, New Jersey. Datascope Corp. shall not have any responsibility in the event
of loss or damage in transit.
1. Connect the modem as shown. See “Connecting the Modem” on page 8-1.
2. All other work is performed through the PC. See the PC•IABP Operating Instructions
(P/N 0070-00-0291) for complete details.
Datascope supplies interface cables which can be custom wired for compatibility with any
monitor which meets the minimum requirements above. Wiring instructions for both ECG and
Arterial Pressure interface cables are provided (see figure 8-2).
1. The cable is supplied with a stereo phone plug to be connected to the CS100 rear
panel ECG Monitor Input jack.
2. The other end should be terminated with the appropriate connector for the external
monitor.
3. The following connections should be made to the external monitor connector:
1. The cable is supplied with a stereo phone plug to be connected to the CS100 rear
panel Pressure Monitor Input jack.
2. The other end should be terminated with the appropriate connector for the external
monitor.
3. The following connection should be made to the external monitor connector.
For assistance in interfacing the CS100 with external monitors, contact the Datascope
Technical Support Department.
* Datascope does not recommend the use of the P/N 0012-00-0467 cable with the CS100.
Language Selection
Date Format Selection
Modem Selection
Display Software Revision
50/60 Hertz Filter Selection
Language Selection
Current Selection English
Deutsch
Français
Español
Japanese
Italiano
Português
1. To enter the date format menu item, use the Navigation Circle's UP and DOWN arrow
keys to highlight the Date Format Selection submenu and then press the Open
Menu key
2. Use the UP and DOWN arrow keys to select the desired format.
3. To retain the selected format, press the Open Menu key.
4. Once the desired format is selected, press the BACK key to move up one menu. The
system restarts and returns to the normal monitoring mode.
1. To enter the modem selection menu item, use the Navigation Circle's UP and DOWN
arrow keys to highlight the Modem Selection submenu.
2. Press the Open Menu key to open the modem selection screen.
3. Use the UP and DOWN arrow keys to highlight the desired modem.
4. To retain the selected modem (e.g., United Kingdom) press the Open Menu key.
Modem Selection
North America
Central/South America, Asia, Far East
Japan
France
Germany
Current Selection United Kingdom
Netherlands
Australia
South Africa
New Zealand
Singapore
Taiwan
User Define/Country
5. Press the BACK key to exit and move up one menu. The system restarts and returns to
the normal monitoring mode.
When the User Define/Country submenu is opened, the following screen is displayed.
User Define/Country
Modem ID String TDK-Germany
InitializationString AT&F-I17Z
Reset String AT&F
Default DTE Baud Rate 9600
Override DTE Default Off
User Define/Country
Modem ID String MultiTech-Germany
InitializationString AT&GCI=FD
Reset String AT&F
Default DTE Baud Rate 9600
Override DTE Default Off
1. To set or modify the modem ID string, initialization the string or reset the string use the
Navigation Circle’s UP and DOWN arrow keys to highlight selection and press the
Open Menu key to open the submenu.
Key Input is displayed at the bottom of the menu screen along with the string to be
modified in square brackets [ ].
User Define/Country
Modem ID String TDK-Germany
InitializationString AT&F-I17Z
Reset String AT&F
Default DTE Baud Rate 9600
Override DTE Default Off
Key Input:
&/%\$-+=ABCDEFGHIJKLMNOPQRSTUVWXYZ
0123456789 SPACE - - SAVE
[ TDK - Germany ]
2. A highlighted cursor is placed on the first character within the square brackets. To
change that character, use the UP and DOWN arrow keys to highlight the desired
character in the key Input section and press the Open Menu key.
The cursor now moves over to the next character within the square brackets. To skip a
character or to go back to a character, highlight either the <- or -> in the Key Input
field and press the Open Menu key. Each time this is done the cursor will move one
space to the left or right.
3. The Initialization string must be set properly for the selected modem to function. The
string for the TDK is AT&F-I (country code) Z where the country code is replaced
with the appropriate number from the following table. The string for the MultiTech 5600
AT+GCI = (country code).
For example, in Austria, the string for the MultiTech modem will be: AT&GCI = FD and
in Brazil the string will be AT&GCI = 16.
MultiTech 5600
COUNTRY COUNTRY
COUNTRY CODE COUNTRY CODE
Argentina 07 Hungary FD
Austria FD Iceland FD
Belgium FD Italy FD
Brazil 16 Korea B5
Canada 99 Liechtenstein FD
Chile FD Luxembourg FD
China FD Malaysia 6C
Cyprus FD Mexico B5
Czech Republic FD Norway FD
Denmark FD Philippines B5
Estonia FD Poland 99
Finland FD Portugal FD
Greece FD Slovak Republic FD
Ireland FD Spain FD
Indonesia 99 Sweden FD
Israel B5 Switzerland FD
Hong Kong 99 Turkey FD
4. The modem selection list allows the TDK DF5660 to be configured for use in many
additional countries. Refer to the following table to find the selection corresponding to
the desired country setting.
COUNTRY SELECTION
Algeria France
Cameroon France
Central African Republic France
Congo France
Ghana United Kingdom
Ivory Coast France
Mali France
Niger France
Nigeria United Kingdom
Pakistan United Kingdom
Senegal France
Togo France
Tunisia France
Yemen United Kingdom
Zambia United Kingdom
European Countries Germany
(not previously listed)
All Other Countries North America
5. Press the BACK key when all initialization information has been entered.
6. Verify the Reset String is set to AT&F.
7. To change the Default DTE Baud Rate use the Navigation Circle’s UP and DOWN
arrows keys to highlight the submenu Default DTE Baud Rate, and then press the
Open Menu key. The open menu displays the available choices for baud rates.
8. To select a new rate, use the Navigation Circle’s LEFT and RIGHT arrow keys, and then
press the Open Menu key to retain the selected rate.
User Define/Country
Modem ID String TDK-Germany
InitializationString AT&F-I17Z
Reset String AT&F
Default DTE Baud Rate 1200 / 2400 / 4800 / 9600
Override DTE Default Off
9. To change the Override DTE Default, highlight that line and press the Open Menu key.
The choices of On and Off display on that line. Choose Off and press the Open
Menu key.
BACK To Exit
1. To enter the 50/60 Hertz Filter Selection submenu, use the Navigation Circle's UP
and DOWN arrow keys to highlight the 50/60 Hertz Filter Selection submenu,
and then press the Open Menu key.
2. Press the UP and DOWN arrow keys to select the desired format, and then press the
Open Menu key to retain it.
3. When the desired format is selected, press the BACK key to move up one menu. The
system restarts and returns to the normal monitoring mode.
10.1 Introduction
This section of the manual lists accessories used with the CS100. Please refer to the
appropriate sections of this manual for detailed instructions on how the accessories are used
in conjunction with the system.
Five different Helium cylinders are available. When either of the 90 liter refillable cylinders
or 99 liter refillable cylinders are ordered, a quantity of three (3) is shipped. When the 140
liter disposable cylinder is ordered, a quantity of one (1) is shipped.
* P/N 0075-02-0001-XX is BSI and APPAVE approved. P/N 0075-02-0002-XX is TUV approved.
Container
Specification: 7.06 cm x 23.19 cm (2.78" x 9.13") Overall Height
31.55 cm (12.42") aluminum cylinder pin-indexed
yoke-type Medical Valve connection per ISO 407:
1991 (E) para. 7.2.7/CGAV-1-1994 connection
No. 930.
CAUTION: Never place fluids on top of this unit. Make sure that the
saline container and tubing do not hang directly over the
IABP. In case of accidental spillage, wipe clean immediately
and have the unit serviced to ensure no hazard exists.
Different leadwire options are provided depending upon the environment in which the IABP
is used. (See below).
High performance (low noise), fully shielded ECG patient trunk cables and leadwires sets are
recommended for general non-operating room use. The fully shielded, low triboelectric effect
cables minimize the level of noise pick-up due to coupled noise sources and motion-induced
ECG artifact which can occur during patient transport and movement.
High performance (low noise), fully shielded ESIS (Electro-Surgical Interference Suppression)
ECG patient trunk cables and leadwire sets are recommended for operating room use. The
fully shielded ESIS leadwire set contains RF chokes to minimize the pick-up of interference
and the risk of ESU-induced patient burns at electrode sites.
The available trunk cable and shielded leadwire sets are as follows (Note that the trunk cable
indicated is the same for either leadwire set).
Power: 9V battery
10.4 Communications
For additional information refer to the CS100 Communications Specification.
The cover is placed on the system with the clear window panel over the battery charge
indicator. A velcro strap is provided to secure the cover.
11.1 Triggering
Trigger Threshold: In all operation modes (AUTO, Semi Auto, and
Manual) both the ECG and Pressure trigger thresholds
are automatically and dynamically adjusted by the
system to compensate for variations in trigger
signal amplitude.
ECG Trigger Threshold: 120 ±20 µV (default setting in all Operation Modes)
Pressure Trigger Threshold: User adjustable between 7 and 30 mmHg (±3 mmHg)
in Semi Auto or Manual Operation Modes
Pacer V / A-V: (This Trigger Source is user selectable in the Semi Auto
or Manual Operation Modes)
Tall T-Wave Rejection: Rejects all T-Waves where Q-T interval is <300 ms
(ECG and Pacer A and the amplitude is <70% of QRS input amplitude.
Trigger Mode)
NOTE: Pacer tail peak amplitudes shall not exceed 25% of the
pacer pulse amplitude per AAMI EC13-2002 paragraph
4.1.4.2. (Pacer and tail rejection performance may be
degraded in Manual timing and Variable ECG gain modes.)
Electro-Surgical Interference
Suppression (ESIS): The operation of an Electro-Surgical Unit in the
proximity of the IABP does not cause any
unrecoverable malfunction or require user
intervention.
Defibrillator Overload
Protection: Withstands up to 360 Joules for damped sinusoidal
(per IEC 60601-2-27:1994) and trapezoidal
(per AAMI DF2:1996) waveforms applied to
100 Ohm load and 50 Ohm electrode impedance
at 20 second intervals
Defibrillator Recovery
Time: 5 seconds maximum for trace to return to screen
from a defibrillator mono pulse
Lead Fault Detection: Guaranteed Lead fault detection when any active
electrode wire becomes open. Guarantee no lead
fault with electrode impedance ≤ 51 k Ohms and
with DC offsets ranging from -300 mV to +300 mV.
Common Mode
Rejection Ratio: 80 dB minimum, at 50/60 Hz with an imbalance
of up to 51 k Ohm in parallel with 47 nF and up
to ±300 mV DC offset.
Frequency Response
to ECG output 0.5 to 135 Hz, -3 dB maximum (with ESU
connector: detection disabled).
11.6 Display
Type: Color TFT Liquid Crystal Display (LCD)
11.7 Printer
Print Mechanism: Thermal Array
11.8 Power
11.8.1 Power Requirements
AC Mains Source: 100 - 120 VAC ± 10%, 50/60 Hz ±3 Hz
220 - 240 VAC ± 10%, 50/60 Hz ±3 Hz
(automatic range switching)
Power Consumption (AC Mains) 180 VA Nominal (90 bpm, low rate battery charge)
NOTE: A reduction in run time can occur over a battery’s life for
reasons such as age, storage temperature and discharge
depth.
* NOTE: A reduction in run time can occur over a battery’s life for
various reasons such as age, storage temperature and
discharge depth.
11.10.3 Shipping
International Safe Transit Association (ISTA) Pre-shipment Test Procedure, Procedure 1B,
June 1998
11.10.4 Vibration/Shock
Sinusoidal Vibration EN 1789:1999 “Medical vehicles and their equipment
-Road ambulances”. FDA “Reviewer Guidance for
Pre-Market Notification Submissions” section n.4 (ii)
specifies sinusoidal vibration test per IEC 68-2-6,
frequency range 10 to 500 Hz, with acceleration
amplitude 1g, 10 cycles in each axis. Non-
operational.
Rough Handling Test IEC 601-1 (1988), sub-clause 21.6, with Amendment 1
(1991) and Amendment 2 (1995)”.
Drop Test:
Steel Sphere Impact Test: ECRI* (AIII.3.3)
* U.S. Department of Commerce, National Technical Information Service, PB-296 892 “Development of Envi-
ronmental Test Methods for Non-Implantable Devices” by Emergency Care Research Institute (ECRI), Pre-
pared for Food and Drug Administration, April,1979.
11.11.3 Shipping
International Safe Transit Association (ISTA) Pre-shipment Test Procedures:, Test Procedure 1,
April 1996.
11.11.4 Vibration/Shock
Operational:
Random Vibration: MIL-STD 810E (Vibration method 514.4, using
Category 1 vibration amplitude for common
carrier transport).
Drop Test:
Steel Sphere Impact Test: ECRI* (AIII.3.3)
Tip-over Test: ECRI* (AIII.3.4)
* U.S. Department of Commerce, National Technical Information Service, PB-296 892 “Development of Envi-
ronmental Test Methods for Non-Implantable Devices” by Emergency Care Research Institute (ECRI), Pre-
pared for Food and Drug Administration, April,1979.
Table 1
The CS100/CS100i is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS100/CS100i should assure that it is used in such an environment.
Table 2
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic of a
magnetic field typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test
level.
Table 3
ELECTROMAGNETIC
IEC 60601 TEST COMPLIANCE ENVIRONMENT –
IMMUNITY TEST LEVEL LEVEL GUIDANCE
Portable and mobile RF
communications equipment
should be used no closer to any
part of the CS100/CS100i,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
Conducted RF 3 Vrms 3 Vrms frequency of the transmitter.
IEC 61000-4-6 150 kHz to 80 MHz
outside ISM bands a Recommended separation
distance
10 Vrms 10 Vrms d = 1.2 x P
150 kHz to 80 MHz
in ISM bands a d = 1.2 x P
Table 3
NOTE: At 80 MHz and 800 MHz, the higher frequency range
applies.
Table 4
NOTE: At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
Radiated Susceptibility: RTCA/DO- 160D, Sec.20, 100 MHz to 8 GHz 5V/m, >90%
Category T AM at 1 kHz
The CS100/CS100i meets the following requirements of Reviewer Guidance for Pre-Market
Notification Submissions, November 1993, Division of Cardiovascular, Respiratory, and
Neurological Devices; Anesthesiology and Respiratory Devices Branch, U.S. Food and Drug
Administration (related to EMC).
Quasi-Static Field
Susceptibility: FDA 11/93 7. ii.f 2 kV/m electric field modulated @
0.5 Hz
Slow Sags and Surges: FDA 11/93 Sec.m.ii.c.3 AC line slow sags to 90 Vrms and
surges to 150Vrms for 500 ms
duration
2
When tested with Baxter, Model PX 600 or Abbot, Model 42582-05 disposable pressure transducers.