SINGLE-PARAMETER MONITOR , Model SPM-1
Pressure Sensor Type
Pressure Measurement Range
High ICP Alarm
Linearity and Hysteresis
External Monitor Output
Class of Equipment (IEC 60601-1)
Protection Against Fluids (IEC 60601-1)
Mode of Operation
Fiberoptic pressure transducer
-10 to +125 mmHg pressure, Resolution of 1 mmHg
0 to 75 mmHg, 1 mmHg increments
See individual catheter specifications
3 Digit, 7 Segment LED Numerical Display
Data acquisition may be accomplished using the SERIAL
DATA CAPTURE program, PN MPM-1-SDC.
For details contact Integra NeuroSciences.
5 µV/V/ mmHg
Rechargeable, sealed lead acid
8-10 hours to full charge
2-4 hours from full charge
15°C to 40°C
700 hPa to 1060 hPa
20% to 95% RH
-20°C to 50°C
500 hPa to 1060 hPa
20% RH to 95% RH non-condensing
100-230 V, 50/60 Hz, 50 VA
282 mm H x 216 mm W x 163 mm D (11.1" x 8.5" x 6.4")
4.1 kg (9.2 lbs.)
DIRECTIONS FOR USE
CE Mark obtained 2002
INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 USA
(800) 654-2873, (609) 275-0500, FAX (609) 275-5363
Hampshire SP10 4DR England
Phone: +44 (0) 1264 345 700
Fax: +44 (0) 1264 332 113
A40369 REV A
FOR EXPORT ONLY
Read carefully prior to use
INTEGRA NEUROSCIENCES LIMITED WARRANTY
Illuminates when the mean ICP is greater
than the ICP alarm limit setting.
5. ALARM LIMIT SET MODE INDICATOR - Illuminates to indicate the SPM-1
is in the ALARM LIMIT SET MODE. In
this mode the displayed value is the ICP
alarm limit setting. This occurs whenever
the UP or DOWN button is pressed.
6. CAL STEP MODE INDICATOR Illuminates to indicate the SPM-1 is in the
CAL STEP MODE. In this mode the displayed value is an artificially generated
pressure signal. This occurs whenever
the CAL STEP BUTTON is pressed.
7. SILENCE ALARM BUTTON - Press
to silence the alarm for 3 minutes.
8. UP and DOWN BUTTONS - Press
the UP or DOWN buttons to initiate the
ALARM LIMIT SET MODE. In this mode
the ICP alarm limit may be set to values
between 1 to 75 mmHg, or off.
9. ALARM DISABLED INDICATOR Illuminates when the ICP alarm is set to
OFF. Flashes when the audible alarm
has been temporarily silenced.
SERVICE / RETURNS
FRONT PANEL (See Figure 1-2)
1. START/STOP BUTTON - Press to
turn SPM-1 on or off.
2. CAL STEP BUTTON - Press to initiate the CAL STEP MODE. Used to calibrate or check correlation of external
bedside monitor. Press and hold to
momentarily interrupt normal pressure
display and substitute an artificially generated pressure signal, which will appear
on both the SPM-1 display and the external bedside monitor. Each press
advances to the next pressure value in
the following series: 0, 20, 40, 100, 125
and back to 0.
3. LED DISPLAY - Normally displays
mean intracranial pressure (ICP in
mmHg). Displays the ICP alarm limit set
point when pressing the UP or DOWN
button to initiate the ALARM LIMIT SET
MODE. Displays an artificially generated
pressure value when pressing the CAL
STEP button to initiate the CAL STEP
4. HIGH ICP ALARM INDICATOR 1
INTEGRA NEUROSCIENCES, warrants that each new INTEGRA NEUROSCIENCES
product is free from defects in material and workmanship under normal use and service
for a period of two (2) years (except as otherwise expressly provided as to accessory
items) from the date of delivery by INTEGRA NEUROSCIENCES to the first purchaser
but not beyond the "Expiration" date stated on any product labeling. Surgical instruments
are guaranteed to be free from defects in material and workmanship when used normally for their intended purpose and in accordance with instructions. Any covered product which is placed by INTEGRA NEUROSCIENCES under a lease, rental or installment
purchase agreement and which requires repair services during the term of such placement agreement shall be repaired in accordance with the terms of such agreement. If
any such defect occurs during the warranty period or term of such placement agreement, the purchaser should communicate directly with the INTEGRA
NEUROSCIENCES’ home office. If returned to INTEGRA NEUROSCIENCES at its
home office, repair or replacement will be carried out at INTEGRA NEUROSCIENCES’
sole discretion, at INTEGRA NEUROSCIENCES subject to the terms of this warranty
and applicable agreements. The defective product should be returned promptly, properly packaged and postage prepaid. Loss or damage in return shipment to INTEGRA
NEUROSCIENCES shall be at CUSTOMER's risk.
IN NO EVENT SHALL INTEGRA NEUROSCIENCES BE LIABLE FOR ANY INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THE
ACQUISITION OR USE OF ANY INTEGRA NEUROSCIENCES PRODUCT. Further,
this warranty shall not apply to, and INTEGRA NEUROSCIENCES shall not be responsible for, any loss arising in connection with the purchase or use of any INTEGRA
NEUROSCIENCES product which has been repaired by anyone other than an authorized INTEGRA NEUROSCIENCES service representative or altered in any way so as,
in INTEGRA NEUROSCIENCES judgment, to affect its stability or reliability, or which
has been subject to misuse, negligence or accident, or which has been used otherwise
than in accordance with the instructions furnished by INTEGRA NEUROSCIENCES.
This limited warranty is exclusive and in lieu of all other warranties, express or implied,
and of all other obligations or liabilities on INTEGRA NEUROSCIENCES part and
INTEGRA NEUROSCIENCES neither assumes nor authorizes any representative or
other person to assume for it any other liability in connection with INTEGRA
INTEGRA NEUROSCIENCES DISCLAIMS ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY
OF QUALITY, OTHER THAN THOSE EXPRESSLY SET FORTH IN THE PRODUCT
LABELING, INCLUDING THE APPLICABLE USER INFORMATION.
This equipment has been tested and found to comply with the limits for medical devices
under EN 60601-1-2. However, there is no guarantee that interference will not occur in a
given situation. If this equipment causes harmful interference or is subject to harmful interference, the user may be able to correct the situation using the following measures:
- Reorient or relocate the device and other devices in the vicinity.
- Connect the device to an outlet on a circuit different from other devices.
- Consult the manufacturer or distributor for further assistance.
Periodic preventive maintenance, performed by qualified technical personnel, as trained
by Integra NeuroSciences, is necessary to ensure proper functioning and calibration of
the Model SPM-1 and the PAC-2 Preamp cable. The recommended maintenance cycle
is 18 months. The date on which the next maintenance is due can be found on the back
panel of the unit. It is important that the user review the next maintenance date on the
back panel at least every 6 months to verify that the monitor is still within the recommended maintenance period. Contact Integra NeuroSciences Customer Service or your
local distributor to make arrangements for the return of the unit. Follow local governing
ordinances and recycling plans regarding disposal or recycling of device or components.
If the SPM-1 fails to perform as specified, and the cause cannot be determined, do not
use or attempt to repair it. For technical assistance, monitor and accessory exchanges,
contract information, and other ordering information, contact your Neurospecialist, local
distributor, or Integra NeuroSciences Customer Service. Should it be necessary to return
your SPM-1 Monitor, contact Customer Service for return authorization and instructions.
Please include a description of the type of information desired, and details of any difficulties you may have experienced.
Direct all inquiries to Integra NeuroSciences at:
Customer Service, Technical Service
Plainsboro, New Jersey, USA
Phone: (800) 654-2873 USA/Canada
(609) 275-0500 (Outside USA)
Customer Service, Technical Service
Andover, Hampshire, England
Phone: +44 (0) 1264 345 700
+44 (0) 1264 332 113
Integra NeuroSciences cannot assume responsibility for loss or damage to returned
equipment while in transit.
10. LOW BATTERY INDICATOR Illuminates when the SPM-1 is operating
on battery power and approximately fifteen minutes battery life remains.
NOTE: Connect to AC power as soon as
possible to maintain battery charge.
11. AC POWER INDICATOR Illuminates when SPM-1 is connected to
AC power. The battery will charge whenever this indicator is illuminated.
BACK PANEL (See Figure 1-3)
12. COMBINATION CORD WRAP,
HANDLE, and BED RAIL HOOK
13. DFU POCKET - Storage location
for the Directions for Use booklet.
14. BEDSIDE MONITOR CONNECTOR - Used for connection to the bedside
14a. ICP Waveform to Bedside Monitor
6-Pin Cannon Connector
15. EQUIPOTENTIAL CONNECTOR Used as the connection point for equipotential systems.
16. RS232 CONNECTOR - Data
Acquisition Port may be connected to a
personal computer running WINDOWS
95 (or compatible) operating system
which uses the application program
SERIAL DATA CAPTURE, PN MPM-1SDC to view the data.
17. AC CONNECTOR - Attachment
point for the AC power cord. Automatically accepts input AC voltages from
100 to 230 Volts, 50 to 60Hz. Must be
plugged into an AC source whenever it is
desired to maintain a charge on the internal battery.
18. POLE CLAMP - Used to secure
the SPM-1 to an equipment pole.
SIDE PANEL (See Figure 1-1)
19. ICP CONNECTION - Attachment
point for the PAC-2 Preamp Cable
19a. ICP Catheter to Preamp connection.
EXPLANATION OF SYMBOLS
Low Battery, when illuminated
Caution, refer to Directions for Use
Type BF Equipment
Stand-by Mode (Start/Stop)
AC Power, when illuminated
Alarms Disabled, when illuminated.
Audible alarm temporarily silenced
Increase ICP Alarm Limit Setting
(adjustment to a maximum).
Decrease ICP Alarm Limit Setting
(adjustment to a minimum).
PLEASE READ DANGER AND
CAUTION SECTIONS ON
PAGE 8 BEFORE PROCEEDING WITH SPM-1 SET-UP AND
CLEANING AND STERILIZING
1. Prior to each use carefully inspect the
SPM-1 power cord and cables to assure
each item is undamaged.
2. The SPM-1 may be placed on an
appropriate table, or, if desired, the unit
may be hung on a bed rail, or mounted
on an equipment pole and secured using
the POLE CLAMP (See Figure 1-3).
NOTE: The SPM-1 POLE CLAMP can
accommodate equipment poles up to
1.2" O.D. Make sure SPM-1 is properly
attached to equipment pole and securely
tightened. The SPM-1 BED RAIL HOOK
will accommodate a bed rail up to 2" O.D.
3. If desired, connect the SPM-1 to an
external bedside monitor system, using
connector 14a (Figure 1-3). Ensure that
the PMIO-SPM cable and the appropriate adapter cable are available prior to
patient usage. Call Integra NeuroSciences Customer Service or your
Neurospecialist for additional information.
4. Connect the SPM-1 equipotential
connector to the equipotential system, if
5. Insert the Power Cord into the AC
CONNECTOR on the back panel of the
SPM-1 (Figure 1-3). Then insert the Plug
into a grounded AC outlet.
The PAC-2 Preamp Cable can be sterilized with ethylene oxide.
It is a good practice to periodically clean the SPM-1 outer surfaces by wiping with a soft,
clean cloth that is slightly moist but not dripping with warm water, or a general non-staining chemical disinfectant.
• Always unplug the SPM-1 from AC power before any major cleaning.
• Never use spraying fluids or fluid jets to clean the SPM-1.
• Do not allow liquid of any type to enter the system.
Refer to the Housekeeping, Central Services, or Infection Control departments in your
facility for further information.
DANGER - Risk of explosion if used in the presence of flammable anesthetics.
• Do not autoclave or immerse the SPM-1 as damage may occur. If the SPM-1 is
exposed to liquids, turn off the unit, remove the power cord and thoroughly dry the
unit before reapplying power.
• Do not use solvents or cleaning agents as they could damage the exterior of the
• To reduce the risk of electric shock do not remove cover. Refer servicing to qualified
• Read Directions for Use before connecting to bedside patient monitors.
• Grounding reliability can only be achieved when connected to Hospital Grade
• Where the integrity of the external PROTECTIVE EARTH CONDUCTOR arrangement is in doubt, the equipment shall be operated from its internal electrical power
• This equipment should not be used with high frequency surgical equipment.
• Integra NeuroSciences Catheters are for single use only. Do not attempt to resterilize
or reuse. Integra NeuroSciences cannot assume any responsibility for damage
caused by resterilized Catheters. Used catheters should be considered as a potential
biohazard. Follow all established laws and regulations pertaining to the handling and
disposal of biohazardous materials.
• The SPM-1 does not measure temperature parameters, and is not appropriate for
use with temperature catheters.
• The SPM-1 measurement range is -10 mmHg to +125 mmHg.
Accessory equipment connected to the analog and digital interfaces must be certified to
the respective IEC standards (i.e. EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the system standard EN 60601-1-1. Anyone who connects additional equipment to the signal input part or signal output part configures a
medical system, and is therefore responsible that the system complies with the requirements of the system standard EN 60601-1-1. If in doubt, consult the technical service
department or your local representative.
CLEANING & STERILIZING
The Integra NeuroSciences SingleParameter Monitor SPM-1 is a compact,
portable device for use with Camino®
Pressure Transducer-Tipped Catheters.
Pressure is measured at the Catheter tip,
eliminating the need for external transducers, fluid, pressure tubing, and flush
The SPM-1 provides a continuous display of mean ICP values in the range of
-10 mmHg to +125 mmHg.
Although the SPM-1 is intended to be a
stand alone system, it also conveniently
connects to hospital bedside monitoring
systems. The PMIO-SPM cable and
appropriate adapter cable may be
ordered seperately to interface the SPM1 to a hospital bedside monitor. A built-in
rechargeable battery permits monitoring
during patient transport.
This procedure is to be performed by a qualified person.
Ensure that the unit is turned off and the power cord has been removed from the
unit before attempting this procedure.
1. Using a flat bladed screwdriver, carefully lift off the battery compartment door, by inserting the screwdriver into the battery compartment notch and twisting.
2. Move the metal battery compartment slide in the direction indicated to open
3. Carefully remove the spade lug connectors from the positive and negative terminals by
grasping only the spade lug connectors, not the attached wire.
4. Gently slide the battery out of the battery compartment.
5. Replace the battery in the battery compartment.
6. Ensure that the terminal side of the battery is on the right hand side (Figure 5). While
observing polarity, reconnect the spade lug connectors to the battery terminals. The "+"
wire to the positive terminal and the "-" wire to the negative terminal.
7. Move the metal battery compartment slide in the direction indicated until it is closed
8. Replace the battery compartment door and snap into place.
9. Dispose of old battery properly, per applicable federal and local regulations.
FIGURE 4 POSITIVE & COMPARTMENT
BATTERY SPADE LUG
1. Turn on the SPM-1 by pressing the
START/STOP button on the front
panel. An audible tone will sound and
the LED DISPLAY will momentarily
indicate 888. The red HIGH ICP
ALARM INDICATOR, green ALARM
LIMIT SET MODE INDICATOR, and
green CAL STEP MODE INDICATOR
will also be momentarily illuminated
permitting verification of these indicators.
2. The SPM-1 software version is displayed, followed by the blinking Check
Catheter Connection message “CCC”.
Zeroing the Catheter
7. Before inserting the catheter into the
patient, ensure that the SPM-1 display
indicates an ICP pressure of “0
mmHg”. If not, use the tool from the
Catheter Kit to turn the zero adjustment on the bottom side of the transducer connector until the ICP pressure
indicates “0 mmHg” (Figure 3).
8. Refer to the Catheter Directions for
Use for proper insertion technique.
Connecting the Preamp
3. Connect the Preamp Cable to the
SPM-1 by inserting the cable connector into the appropriate receptacle
Connecting the Catheter
4. Select the desired Camino Pressure
Monitoring Kit. Specific Directions for
Use may be found with each Pressure
5. Remove the catheter from the kit tray
and firmly connect the catheter connector into the preamp connector
(Figure 3). After a short system test,
indicated by “-” moving across the display, the SPM-1 will display a pressure
6. The LED DISPLAY’s right-most decimal point will blink each time the display is updated with a new measurement. This permits verification of continual data updates.
SYSTEM DESCRIPTION /
SET-UP / OPERATION
SPM-1 BATTERY REPLACEMENT PROCEDURE
the current ICP Alarm Limit setting
on the display. The ALARM LIMIT
SET MODE INDICATOR is continually illuminated while in this
mode. To adjust the ICP Alarm limit
press and hold the UP or DOWN
buttons. To view the current ICP
Alarm limit press the UP or DOWN
button once. Within a few seconds
the SPM-1 willl exit the ALARM
LIMIT SET MODE and return to
normal pressure display. The ICP
Alarm limit may be turned off by
continually pressing the DOWN
button. The ALARM DISABLED
INDICATOR is continually illuminated when the ICP Alarm limit is
11. If the mean ICP exceeds the ICP
Alarm limit the following alarms are
Display will not turn on.
• Verify power cord is plugged into a live AC
Will not operate on battery.
• Connect to AC power for approximately 8
Low BATTERY Indicator
SPM-1 Display reads:
Zeroing a Patient Monitor
9. If the SPM-1 is connected to an external bedside monitor, the CAL STEP
BUTTON may be used to calibrate or
balance the bedside monitor. Pressing
the CAL STEP BUTTON causes the
SPM-1 to enter the CAL STEP
MODE. The CAL STEP MODE temporarily interrupts normal pressure
display and substitutes a calibration
pressure signal on both the SPM-1
and on the external bedside monitor.
The CAL STEP MODE INDICATOR
is illuminated while in this mode. Each
press of the CAL STEP BUTTON
advances the calibration pressure signal to the next value in the following
series: 0, 20, 40, 100, 125 and back to
0. Press the CAL STEP BUTTON
repeatedly until 0 mmHg is displayed
on the SPM-1. While keeping the button depressed to maintain 0, simultaneously zero the bedside monitor, wait
until the bedside monitor responds,
then release the CAL STEP BUTTON. Within a few seconds the SPM1 will exit the CAL STEP MODE and
return to normal pressure display.
Note that the CAL STEP BUTTON
may be used at any time, and does
not affect the transducer calibration.
Setting the ICP Alarm
10. The ICP Alarm limit may be set from
1 to 75 mmHg or off. If the mean ICP
exceeds the ICP Alarm limit the
SPM-1 will initiate audible and visual
alarm indicators as described below.
Pressing the UP or DOWN buttons
causes the SPM-1 to enter the
ALARM LIMIT SET MODE. The
ALARM LIMIT SET MODE
momentarily interrupts the normal
pressure display and substitutes
to 10 hours to fully charge battery. The SPM-1
may be used on AC power while charging.
• Check connection between Catheter,
Preamp Cable and SPM-1
• Replace Preamp Cable
• Replace SPM-1
• Replace Catheter
SPM-1 Display reads:
"- - -"
• Check connection between Catheter and
• An audible alarm is cycled on and
off twice per second.
• Check connection between Preamp Cable
• The HIGH ICP ALARM INDICATOR is continually illuminated.
• Replace Preamp Cable
• Replace SPM-1
• Replace Catheter
• Value outside operating range -10 mmHg to
• The mean ICP value blinks.
Silencing the Alarm
12. The audible alarm may be silenced
for three minutes by pressing the
SILENCE ALARM BUTTON. This
will result in the ALARM DISABLED
INDICATOR blinking on and off. After
three minutes have elapsed the audible alarm will automatically re-activate and the ALARM DISABLED
INDICATOR will stop blinking.