Camino Model CAM01 Directions for Use Issue 2

INTEGRA STANDARD WARRANTY

diastolic values) display. 5. TREND - Press to graphically display the last 12 hours of ICP, CPP values on the Camino display. Press again to display the last 24 hours of ICP, CPP values. Press again to return to the pressure display. 6. LCD Display - Displays ICP waveform (in mmHg), cerebral perfusion pressure (CPP in mmHg), mean intracranial pressure (ICP in mmHg), intracranial temperature (ICT in degrees C), systolic and diastolic values and trend data. 7. SILENCE ALARM - Press to silence the physiologic alarms for 3 minutes. 8. UP and DOWN - Press the UP or DOWN arrows to set or disable the ICP and/or CPP alarms. 9. AC Power Indicator - Illuminates when the Camino is connected to AC power. The battery will charge whenever this indicator is illuminated.

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SERVICE / RETURNS WARRANTY

FRONT PANEL (See Figure 1) 1. START/STOP - Press to turn the Camino on or off. 2. SCALE - Press to change scale of pressure waveform on the Camino display. Each press advances the scale through a range of -10 to 200 mmHg. 3. CAL STEP - 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 Camino display and on the external bedside monitor. Each press advances to the next mmHg value in the following series: 0, 20, 40, 100, 200 and back to 0. 4. SYS/DIAS - Press to toggle between the CPP, ICP, ICT (cerebral perfusion pressure, intracranial pressure, intracranial temperature) display and the SYSTOLIC, ICP, DIASTOLIC (cranial systolic, mean intracranial pressure and cranial 1

INTEGRA LIFESCIENCES CORPORATION and its wholly owned subsidiaries ("INTEGRA") warrant to INTEGRA authorized distributors and the original purchaser only that each new INTEGRA product is free from manufacturing 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 (or its authorised distributor) to the original purchaser, but in no event beyond the expiration date stated on any product labeling. For purposes of products sold by INTEGRA through an authorised distributor of INTEGRA, "original purchaser" shall include the purchaser of INTEGRA products to whom the distributor first sells the product.
Surgical instruments are guaranteed to be free from defects in material and workmanship when maintained and cleaned properly and used normally for their intended purpose.
Any covered product that is placed by INTEGRA under a lease, rental or installment purchase agreement and that requires repair service during the term of such placement agreement shall be repaired in accordance with the terms of such agreement. If any covered defect occurs during the warranty period or term of such placement agreement, the purchaser or distributor should communicate directly with INTEGRA. If purchaser or distributor seeks to invoke the terms of this warranty, the product must be returned to INTEGRA. The defective product should be returned promptly, properly packaged and postage prepaid. Loss or damage in return shipment to INTEGRA shall be at senders risk. INTEGRA's sale responsibility under this warranty shall be repair or replacement, at INTEGRA's sole discretion at INTEGRA's expense, subject to the terms of this warranty and applicable agreements. IN NO EVENT SHALL INTEGRA BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE ACQUISITION OR USE OF ANY INTEGRA PRODUCT. Further, this warranty shall not apply to, and INTEGRA shall not be responsible for, any loss arising in connection with the purchase or use of any INTEGRA product that has been repaired by anyone other than an authorised INTEGRA service representative or altered in any way so as, in INTEGRA's 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. THIS INTEGRA LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON INTEGRA'S PART OR THE PART OF ITS DISTRIBUTORS, AND INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE OR OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA'S PRODUCTS. INTEGRA 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 AS WELL AS ANY EXPRESS OR IMPLIED WARRANTY TO PATIENTS. No warranty or guarantee may be created by any act or statement nor may this Standard Warranty be modified in my way, except as a result of a writing signed by an officer of INTEGRA. These limitations on the creation or modification of this warranty may not be waived or modified orally or by any conduct. IN NO EVENT SHALL INTEGRA authorised DISTRIBUTORS BE LIABLE TOWARDS THE ORIGINAL PURCHASER FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH TIlE ACQUISITION OR USE OF ANY INTEGRA PRODUCT. Further, this warranty shall not apply to, and INTEGRA authorised distributors shall not be responsible towards the original purchaser for, any loss, arising in connection with the purchase or use of any INTEGRA product that has been repaired by anyone other than an authorised INTEGRA service representative or altered in any way so as 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. THIS INTEGRA DISTRIBUTOR LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES TOWARDS THE ORIGINAL PURCHASER, EXPRESS OR IMPLIED, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES TOWARDS THE ORIGINAL PURCHASER ON INTEGRA authorised DISTRIBUTOR'S PART. INTEGRA AUTHORISED DISTRIBUTORS DISCLAIM ALL OTHER WARRANTIES TOWARDS THE ORIGINAL PURCHASER, EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY AS WELL AS ANY EXPRESS OR IMPLIED WARRANTY TO PATIENTS.

CUSTOMER SERVICE/RETURNS Periodic preventive maintenance, performed by qualified technical personnel, as trained by Integra NeuroSciences, is necessary to ensure proper functioning and calibration of the Camino Monitor and the 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 Camino Monitor 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 Camino 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) Fax: (609) 275-5363 Customer Service/Technical Service Andover, Hampshire, England Phone: +44 (0) 1264 345 700 Fax: +44 (0) 1264 332 113 Integra NeuroSciences cannot assume responsibility for loss or damage to returned equipment while in transit.

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10. Low BATTERY Indicator - Illuminates when the Camino is operating on Battery power and less than fifteen minutes battery life remains. NOTE: Connect to AC power as soon as possible to prevent loss of trend data and to maintain battery charge. 11. ALARM DISABLED Indicator Illuminates when both the ICP and CPP alarms are set to OFF. Flashes when either alarm is temporarily silenced. BACK PANEL (See Figure 2) 12. COMBINATION CORD WRAP 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 monitor. 14a. ICT data to Bedside Monitor Standard Phone Plug 14b. ICP Waveform to Bedside Monitor 6-Pin Cannon Connector 14c. Arterial Pressure Data from Bedside Monitor Mini Phone Plug 15. EQUIPOTENTIAL CONNECTOR Used as the connection point for equipotential systems. 16. ICP ISOLATED ANALOG CONNECTOR- Used for data acquisition needs. Requires 0.141" miniature audio male plug (Switchcraft“ Model 750), tip positive, shank negative. Output is the standard 1V/100 mmHg. 17. 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-1-

SDC to view the data. 18. AC CONNECTOR - Attachment point for the AC power cord. Automatically select input AC voltage of 100, 115 or 230 Volts. Must be plugged into an AC source whenever it is desired to maintain a charge on the internal battery. Power cord can be used as mains disconnect. 19. POLE CLAMP - Used to secure the Camino to an equipment pole. SIDE PANEL (See Figure 3) 20. ICP CONNECTION - Attachment point for the Preamp Cable Connector. 20a. ICP Catheter to Preamp connection. 21. TEMPERATURE CONNECTION Attachment point for the Temperature Cable Connector. 21a. ICT Catheter temperature 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 Alarm Disabled, when illuminated. Flashing during temporary disable period. Increase ICP Alarm Limit Value (adjustment to a maximum). Decrease ICP Alarm Limit Value (adjustment to a minimum). Silence Alarm Equipotential Terminal

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CAMINO SYSTEM DESCRIPTION

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CAMINO SET-UP 1. Carefully unpack the Camino, Power Cord, and Cables. Check prior to each use to be sure each item is undamaged. 2. The Camino 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 tightened using the POLE CLAMP (See Figure 2). NOTE: The POLE CLAMP can accommodate equipment poles up to 1.2" O.D. Make sure the Camino is properly attached to equipment pole and securely tightened. The BED RAIL HOOK will accommodate a bed rail up to 2" O.D. 3. If desired, connect the Camino to an external bedside monitor system, using connectors 14a, 14b, 14c as required (Figure 2). Ensure that the necessary connectors and modules are available prior to patient usage. Call Integra NeuroSciences Customer Service or your Neuro Specialist with questions. 4. Connect the Camino equipotential connector to the equipotential system, if required. 5. Insert the Power Cord into the AC CONNECTOR on the back panel of the Camino (Figure 2). Then insert the Plug into a grounded AC outlet.

CLEANING AND STERILIZING The Camino Preamp Cable can be sterilized with ethylene oxide. It is a good practice to periodically clean the Camino outer surfaces by wiping with a soft, clean cloth that has been dampened with warm water, or a general non-staining chemical disinfectant. 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. CAUTIONS

Disconnect catheter from the PAC-1 cable before defibrillating patient. Physician must use caution when simultaneously using other medical electrical equipment connected to patient.
Do not autoclave or immerse the Camino as damage may occur. If the Camino 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 plastic exterior of the Camino.
To reduce the risk of electric shock do not remove cover. Refer servicing to qualified service personnel.
Read Directions for Use before connecting to bedside patient monitors.
Grounding reliability can only be achieved when connected to Hospital Grade Receptacle.
Where the integrity of the external PROTECTIVE EARTH CONDUCTOR arrangement is in doubt, the equipment shall be operated from its internal electrical power source (battery).
This equipment should not be used with high frequency surgical equipment
Use of this equipment is restricted to one patient at a time.
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. 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. 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.

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BATTERY REPLACEMENT CLEANING & STERILIZING

The Integra NeuroSciences Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure/Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP=mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analog output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a noninvasive blood pressure cuff. Although the Camino is intended to be a stand alone system, it also conveniently connects to hospital bedside monitoring systems. A built-in rechargeable battery permits monitoring during patient transport.

PLEASE READ DANGER AND CAUTION SECTIONS ON PAGE 12 BEFORE PROCEEDING WITH CAMINO SET-UP AND OPERATION

CAMINO OPERATION

This procedure is to be performed by a qualified person.

1. Turn on the Camino by pressing the START/STOP button on the front panel. The device will display the "Integra NeuroSciences, Camino" logo (Figure 4). 2. Connect the Preamp Cable to the Camino by inserting the two cable connectors in the appropriate receptacle (Figure 5). 3. Select the desired Camino Pressure Monitoring Kit. Specific Directions for Use may be found with each Pressure Monitoring Kit. 4. Remove the Catheter from the Kit tray and firmly connect the Transducer Connector(s) into the Preamp Connector(s) (Figure 6). (If a pressure only catheter is used, then the temperature input connector will remain unconnected). After a short system test, the Camino display will change to the CPP, ICP, ICT display (Figure 7).

CAUTION Ensure that the unit is turned off and the power cord has been removed from the unit before attempting this procedure. 1. Using a screwdriver, loosen the retaining screw on the battery compartment door and remove the door from its location. 2. Move the metal battery compartment slide in the direction indicated to open (Figure 20). 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 21). 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 (Figure 20). 8. Replace the battery compartment door and fully tighten the retaining screw. 9. Dispose of old battery properly, per applicable federal and local regulations.

FIGURE 20 POSITIVE & COMPARTMENT NEGATIVE TERMINALS

SYSTEM DESCRIPTION / SET-UP / OPERATION

CAMINO BATTERY REPLACEMENT PROCEDURE

FIGURE 4

FIGURE 5

FIGURE 6

FIGURE 21

SLIDE

FIGURE 7 BATTERY SPADE LUG CONNECTOR

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4

5

FIGURE 8

CAMINO TROUBLESHOOTING (continued) SYMPTOM ICT reads: "- - -"

FIGURE 9

CPP reads: "- - -"

REMEDY

ICP only catheter in use (No ICT signal)

Check connection between Catheter Temperature Connector, Preamp Cable and Camino

Replace Preamp Cable

Replace Camino

Replace Catheter with a new ICP/ICT Catheter

Value outside operating range (16.7¡C to 42.2¡C)

No Arterial Pressure signal

Check connection between Bedside Monitor and Camino

Check connection between Catheter, Preamp Cable and Camino

Replace Bedside Monitor Cable

Replace Preamp Cable

Replace Camino

Replace Bedside Monitor

FIGURE 10

Replace Catheter

MAP reading cannot be acquired from a non-invasive blood pressure cuff

Value outside operating range 0 mmHg to 210 mmHg

TROUBLESHOOTING

5. Before inserting the Catheter into the patient, ensure that the Camino 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 8). Also ensure that the temperature is a reasonable value, such as room temperature, before insertion of the Catheter into patient. 6. After the Catheter has been inserted into the patient (see the Catheter Directions for Use for proper insertion technique), select the appropriate scale by repeatedly pressing the SCALE button on the front panel (Figure 9). 7. If the Camino is connected to an external bedside monitor, the CAL STEP button (Figure 10) may be used to calibrate or balance the bedside monitor. Each press advances to the next mmHg value in the following series: 0, 20, 40, 100, 200 and back to 0. The CAL STEP momentarily interrupts normal pressure display and substitutes a calibration pressure signal on both the Camino and on the external bedside monitor. Press the CAL STEP button repeatedly until 0 mmHg is displayed on the Camino. 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 Camino will return to the pressure display. Note that the CAL STEP button may be used at any time, and does not affect the transducer calibration.

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CAMINO TROUBLESHOOTING SYMPTOM

REMEDY

Display will not turn on.

Verify power cord is plugged into a live AC power source.

Will not operate on battery.

Connect to AC power for approximately 8 to 10 hours to fully charge battery. The Camino may be used on AC power while charging.

Waveform off screen or too small.

Press SCALE button to change scale.

Camino Display reads: "CHECK CATHETER CONNECTION"

Low BATTERY Indicator illuminated.

ICP, Systolic or Diastolic reads: "- - -"

Check connection between Catheter, Preamp Cable and Camino
Replace Preamp Cable

Replace Camino

Replace Catheter

Check connection between Catheter and Preamp Cable

Check connection between Preamp Cable and Camino

Replace Preamp Cable

Replace Camino

Replace Catheter

Value outside operating range -50 mmHg to 300 mmHg

8. Press the SYS/DIAS button to toggle between CPP, ICP, ICT and SYS, ICP, DIAS displays. 9. Press the TREND button to display the mean ICP and CPP values recorded during the preceding 12 hours (Figure 11 or 12). With the next press of the trend button, the mean ICP and CPP for the preceding 24 hours will be displayed. Press again to return to the pressure display. To clear trend, turn the Camino off momentarily. NOTE: The trend information will be lost if the Camino is turned off or if the battery discharges completely and the Camino turns itself off, or if the catheter is disconnected from the monitor. NOTE: ICT and CPP values will be displayed ONLY when using the appropriate Catheter and/or bedside monitor input connections. NOTE: When not in use, the Camino must be connected to AC power to maintain battery charge. TO DISPLAY THE SOFTWARE VERSION (Figure 13) Example of Software version display:

Hold the DOWN button until the SOFTWARE VERSION appears on the screen.
Wait approximately 5 seconds for the graph screen to appear.

FIGURE 11 NO CPP SIGNAL APPLIED

FIGURE 12 CPP SIGNAL APPLIED

PA 1.31 Pressure Version Minor Rev. A Major Rev. 1.31

FIGURE 13 SOFTWARE VERSION SCREEN

VG 1.31 Video Session Minor Rev. G Major Rev. 1.31

Make sure the Camino is powered off. Press and hold the DOWN button.
While keeping the DOWN button depressed, power on the Camino by pressing the START/STOP button.

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While the Camino is on, press the UP or DOWN button, view the Alarm Select Screen.
Press the UP button to select the High ICP ALARM.
Press the UP or DOWN button to set the ICP ALARM to the desired level.
Wait approximately 5 seconds for ICP ALARM to be set.
Pressing the DOWN button until the word "OFF" appears disables this alarm. 7

FIGURE 14 FILL GRAPH MODE

FIGURE 15 LINE GRAPH MODE

FIGURE 16 ALARM SELECT SCREEN

FIGURE 17 HIGH ICP ALARM SCREEN(with default)

TO SET LOW CPP ALARM (Figure 18, 19)
The initial default CPP ALARM level is OFF. After that, the CPP ALARM level is saved every time it is set.
Reminder: The alarm sounds and the CPP parameter blinks when CPP goes lower than the set point. Directions:
While the Camino is on, press the UP or DOWN button, view the Alarm Select Screen.
Press the DOWN button to select the Low CPP ALARM.
Press the UP or DOWN button to set the CPP ALARM to the desired level.
Wait approximately 5 seconds for CPP ALARM to be set.
Pressing the DOWN button until the word "OFF" appears disables this alarm. TO SILENCE THE ALARM
The initial default CPP ALARM and ICP ALARM levels are OFF. After that, the CPP ALARM and ICP ALARM levels are saved in memory every time they are set. Directions
Press the SILENCE ALARM button. The ALARM DISABLED INDICATOR will flash and whichever parameter, ICP or CPP, was in alarm mode will now be silenced for 3 minutes and that parameter will flash on the screen. NOTE: The parameter that is in alarm mode will blink (even if it has been silenced). If both alarms were in alarm mode when the SILENCE ALARM button was pressed, both alarms will be silenced. If one parameter (ICP or

CPP) has been silenced and the other parameter goes into its alarm mode during the 3 minute silence period, the silence alarm mode is disabled (the alarm sounds). BOTH ALARMS OFF
As a warning, the ALARM DISABLED INDICATOR will be ON (and the alarms will be disabled) when both of the alarms have been set to OFF. LOW BATTERY AUDIBLE ALARM
When the Camino is operating on battery power and has less than 15 minutes of life remaining, a continuous audible alarm will sound and the low battery LED will illuminate. This audible alarm will override audible physiologic alarms, whether active or silenced. The SILENCE ALARM button does not disable this alarm. FIGURE 18 ALARM SELECT SCREEN

FIGURE 19 LOW CPP ALARM SCREEN(with default)

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ALARM FUNCTIONS

TO CHANGE THE GRAPH MODE (Figure 14, 15) This feature is available on software version 1.29 and later.
The graph mode can be either LINE or FILL.
The initial default graph mode is FILL. The graph mode is saved every time it is changed. Directions:
Make sure the Camino is powered off.
Press and hold the SYS/DIAS button.
While keeping the SYS/DIAS button depressed, power on the Camino by pressing the START/STOP button.
Hold the SYS/DIAS button until the graph screen appears.
Repeat the above to revert to the FILL Graph Mode. TO SET HIGH ICP ALARM (Figure 16, 17)
The initial default ICP ALARM is set to OFF. After that, the level is saved every time it is set.
Reminder: The alarm sounds and the ICP parameter blinks when ICP goes higher than the set point. Directions: