Camino Model CAM01 Technical Manual Issue 2

Camino Adanced Monitor Model CAM01 Technical Manual 1

Introduction 1.1 1.2 1.3 1.4 1.5

2

Operation 2.1 2.2

3

Operational Testing... 3-2 Battery Replacement... 3-26 Bedside Monitor Calibration... 3-27

Troubleshooting 4.1 4.2 4.3 4.4 4.5

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General Operation... 2-2 Principles of Operation ... 2-9

Testing and Preventive Maintenance 3.1 3.2 3.3

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Disclaimer and Warnings... 1-2 System Overview ... 1-4 Technical Specifications ... 1-7 Limited Warranty... 1-10 Contact Information ... 1-11

Introduction... 4-2 Power Supply Malfunctions... 4-3 LCD Malfunctions ... 4-4 Error Messages... 4-5 Cabling and Interfacing Problems ... 4-7

Technical Notes

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1 Introduction 1.1

Disclaimer and Warnings... 1-2

1.2

System Overview ... 1-4

1.3

Technical Specifications ... 1-7

1.4

Limited Warranty... 1-10

1.5

Contact Information ... 1-11

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1.1 Disclaimer and Warnings PROPRIETARY INFORMATION INFORMATION CONTAINED IN THIS TECHNICAL MANUAL IS PROPRIETARY TO INTEGRA NEUROSCIENCES AND MAY BE USED ONLY FOR THE PURPOSE OF PERFORMING OPERATIONAL CHECKS. THE PURCHASE OR POSSESSION OF THIS MANUAL DOES NOT CONFER, TRANSFER OR LICENSE ANY OTHER RIGHTS TO THIS INFORMATION. ANY OTHER USE OR DISCLOSURE AND/OR REPRODUCTION (BY ANY METHOD) OF THE INFORMATION CONTAINED HEREIN IS STRICTLY PROHIBITED UNLESS WRITTEN PERMISSION IS OBTAINED FROM INTEGRA NEUROSCIENCES. AUTHORIZED SERVICE This manual is intended for use by biomedical personnel to perform operational checks. Any adjustments or procedures that exceed the scope of this manual should be referred to Integra NeuroSciences. Integra NeuroSciences does not condone or approve of service activity on its products by anyone other than Integra NeuroSciences personnel; and Integra NeuroSciences is not responsible for any unauthorized repairs. DEFINITION OF DANGER, CAUTION AND NOTE Danger – means there is the possibility of injury or death to you or others. Caution – means there is the possibility of damage to the unit or other property. Note – indicates points of particular interest for more efficient and convenient operation. SAFETY CONSIDERATIONS Danger – Risk of explosion if used in the presence of flammable anesthetics. Caution – Do not autoclave or immerse the Camino Advanced Monitor as damage may occur. If the Camino Monitor is exposed to liquids, turn off the unit, remove the power cord and thoroughly dry the unit before reapplying power. Caution – Do not use solvents or cleaning agents as they could damage the plastic exterior of the Camino Advanced Monitor. Caution – To reduce the risk of electric shock do not remove the cover. Refer servicing to qualified personnel. Caution – Read Directions for Use before connecting to bedside patient monitors. Caution – Grounding reliability can only be achieved when connected to Hospital Grade Receptacle.

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Caution – 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). Caution – This equipment should not be used with high frequency surgical equipment. Caution – Integra NeuroSciences Catheters are for single use only. Do not attempt to re-sterilize or reuse. Integra NeuroSciences cannot assume any responsibility for damage caused by re-sterilized 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. Caution – The Camino Advanced Monitor contains Static Sensitive Devices. Observe proper ESD precautions when working with Static Sensitive Devices. SHIPPING INSTRUCTIONS A shipping container is available. To insure proper preparation and shipping, contact Integra NeuroSciences for instructions. APPLICABILITY This Technical Manual is applicable to the Camino Advanced Monitor with waveform display, Model CAM01. Contact Integra NeuroSciences for information for equipment not covered in this manual. Integra NeuroSciences reserves the right to change specifications and procedures without notice.

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1.2 System Overview

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Figure 1-1. Front Panel 1. 2. 3. 4.

START/STOP – Press to turn Camino on or off. SCALE – Press to change scale of pressure waveform on Camino Display. CAL STEP - Used to calibrate or check correlation of external bedside monitor. SYS/DIAS – Press to toggle between the CPP-ICP-ICT display and the SYSTOLICICP-DIASTOLIC display. 5. TREND – Press to graphically display the last 12 or 24 hours of ICP and/or CPP values. 6. LCD DISPLAY – Displays ICP waveform, numerical values and trend data. 7. UP and DOWN – Press the button(s) to set the desired alarm limit value. 8. SILENCE ALARM – Press to silence the alarm for 3 minutes. 9. ALARM DISABLED INDICATOR – Illuminates whenever the ICP alarm limit is set to OFF. Flashes when alarm is temporarily silenced. 10. LOW BATTERY INDICATOR – Illuminates when Camino is operating on Battery power and less than fifteen minutes battery life remains. 11. AC POWER INDICATOR - Illuminates when Camino is connected to ~AC power. The battery will charge whenever this indicator is illuminated.

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14 15 16 17 19

18

Figure 1-2. Rear Panel

12. 13. 14. 15. 16. 17. 18.

19.

COMBINATION CORD WRAP and BED RAIL MOUNT DFU POCKET – Storage location for the Directions for Use booklet. BEDSIDE MONITOR CONNECTOR – Used for connection to the bedside monitor. EQUIPOTENTIAL CONNECTOR – Used as the connection point for equipotential systems. ICP ISOLATED ANALOG CONNECTOR – Used for data acquisition needs. Provides 1V/100 mmHg output suitable for computer ADC’s or a strip chart recorder. RS232 CONNECTOR – Used for data acquisition needs. Please contact Integra NeuroSciences for details on use of this digital data. AC CONNECTOR – Attachment point for the ~AC power cord. Automatically selects 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. POLE CLAMP – Used to secure the Camino to an equipment pole.

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20a 20c 20b

Figure 1-3 Bedside Monitor Cable

20. BEDSIDE MONITOR CONNECTOR – Used for connection to the bedside monitor. 20a. ICT data to Bedside Monitor (Standard Phone Plug) 20b. ICP Waveform to Bedside Monitor (6-Pin Cannon Connector) 20c. Arterial Pressure Data to Camino (Miniature Phone Plug)

22a

21a

22 21

Figure 1-4 ICP & ICT Connectors

Figure 1-5 Preamp Cable

21. ICP CONNECTION – Attachment point for the Preamp Cable Connector. 21.a ICP Catheter to Preamp connection. 22. TEMPERATURE CONNECTION – Attachment point for the Temperature Cable Connector. 22.a ICT Catheter temperature connection.

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1.3 Technical Specifications INTRACRANIAL PRESSURE (ICP) Sensor Type:

Fiber-optic pressure transducer

Range:

-10 to +250 mmHg

Resolution:

1mmHg for LCD display 0.125 mmHg for Patient Monitoring Systems

Linearity:

See individual catheter specifications.

Hysteresis:

See individual catheter specifications.

Freq. Response:

120 Hz nominal, 100 Hz minimum (3dB down) 1.32 mSec for analog output

Accuracy:

± 1 mmHg

Reference Pressure:

Atmospheric

INTRACRANIAL TEMPERATURE (ICT) Sensor Type:

Thermistor transducer

Display Range:

16.7°C to 42.2°C (65°F to 108°F)

Accuracy:

± 0.3°C (0.5°F) [30ºC - 40ºC]

MEAN CEREBRAL PERFUSION PRESSURE (CPP) Type:

Calculated

Range:

0 to 200 mmHg

Resolution:

1 mmHg

Accuracy:

± 1 mmHg

ALARMS Audible:

2kHz ± 1kHz signal, ON 0.5 seconds and OFF 0.5 seconds at full amplitude

High ICP Alarm:

0 to 250 mmHg, 1 mmHg increments

Low CPP Alarm:

0 to 150 mmHg, 1 mmHg increments

Alarm Silence:

3 minutes

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MONITOR INPUTS “Trapezoidal” pre-amplifier input connection for Integra NeuroSciences ICP catheters Isolated 3-wire thermistor based TDC input for Integra NeuroSciences ICP/ICT catheters. Isolated Arterial Pressure (AP) for bed side patient monitoring systems. (1V/100 mmHg) MONITOR OUTPUTS Analog ICP for patient monitoring systems. (5μV/V/mmHg) (6-Pin CANNON WK6 connector) Analog ICT for patient monitoring systems. (Standard 3-wire YSI 400 interface) (Switchcraft™ ¼” Plug connector) Analog ICP for data recording. (1V/100 mmHg) (Switchcraft™ Model 750 connector) RS-232 Serial data port. Contact Integra NeuroSciences for details. (9 pin DB9 male connector) DISPLAY Type:

Backlit TFT active matrix LCD panel

Parameters displayed:

Pressure Waveform CPP, ICP, ICT (Main Screen) Systolic, ICP, Diastolic (Systolic/Diastolic Screen) 12 and 24 hour Trend Information (ICP and CPP)

BATTERY Type:

Rechargeable, sealed lead acid

Charge Time:

8-10 hours to full charge

Operation Time:

1-2 hour from full charge

POWER REQUIREMENTS 100-230 V, 50/60 Hz, 50 VA MONITOR OPERATING LIMITS Temperature:

15°C to 40°C (59°F to 104°F)

Pressure:

700 hPa to 1060 hPa (20.67 inHg to 31.30 inHg)

Humidity:

20% to 95% RH

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SHIPPING/STORAGE LIMITS Temperature:

0°C to 50°C (32°F to 122°F)

Pressure:

500 hPa to 1060 hPa (14.76 inHg to 31.30 inHg)

Humidity:

20% RH to 95% RH non-condensing

PHYSICAL DIMENSIONS Size:

335 mm H x 240 mm W x 115 mm D (12.9” x 9.4” x 4.5”)

Weight:

4.4 kg (9.8 lbs.)

IEC-60601-1 Class of Equipment:

Class 1

Protection Against Fluids:

Ordinary

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1.4 Limited Warranty 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. Any covered product which is placed by INTEGRA NEUROSCIENCES under a lease, rental or installment purchase agreement and which requires repair service 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' expense, 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 be 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 NEUROSCIENCES products. 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. The foregoing shall not relieve INTEGRA NEUROSCIENCES from strict tort liability, if otherwise applicable under governing law, for damages for personal injury caused by a product defect that made the product unreasonably dangerous at the time it was sold or placed.

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1.5 Contact Information Customer Service Department Integra NeuroSciences 105 Morgan Lane Plainsboro, New Jersey 08536 (800) 997-4868 (USA/Canada) (609) 275-0500 (International) (609) 275-5363 (FAX) Technical Service Department Integra NeuroSciences 5955 Pacific Center Blvd San Diego CA 92121 (858) 455-1115 (USA/Canada) (858) 455-8298 (FAX) EMEA Service Centre Integra NeuroSciences GmbH Halskestrasse 25 Ratingen 40880 Germany +49 2102 5535 6150 +49 2102 942 4872 (FAX)

CE Mark obtained in 1998

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2 Operation 2.1

General Operation... 2-2

2.2

Principles of Operation ... 2-9 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5

The Camino Catheter... 2-10 Board 1 – Digital Board ... 2-12 Board 2 – Analog Board... 2-13 Board 3 – Power Supply, AC Input... 2-18 Board 4 – Power Supply, DC Output ... 2-19

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2.1 General Operation 1. Turn on the Camino by pressing the START/STOP button on the front panel. The screen will display the “Camino Logo”(Figure 2-1).

Figure 2-1 Camino Logo

2. Connect the Preamp Cable to the Camino by inserting the two cable connectors in the appropriate receptacle (Figure 2-2). Note the red alignment marks on the cable connectors and the side panel.

Temperature Transducer

Pressure Transducer Figure 2-2 Preamp Cable to Camino

3. Select the desired Camino Pressure Monitoring kit. Specific Directions For Use may be found in the User information insert provided with each Pressure Monitoring Kit.

Figure 2-3 Catheter to Preamp Cable

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4. Remove the Catheter from the kit tray, and firmly connect the Transducer Connector(s) into the Preamp Connector(s) (Figure 2-3). (If a pressure only catheter is used, then the temperature connector will remain unconnected). After a short system test, the display will change to the ICP/ICT display (Figure 2-4). Figure 2-4 CPP/ICP/ICT Display

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 (Figure 2-5) on the bottom side of the Transducer Connector until the ICP Pressure indicates “0 mmHg”. Also, ensure that the temperature is a reasonable value, such as room temperature, before insertion of the Catheter into the 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 Camino front panel (Figure 2-6).

Zero Adjustment

Figure 2-5 ICP Catheter Transducer

Scale Button

Figure 2-6 Scale Button

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8.

If the Camino is connected to an external bedside monitor, the CAL STEP button (Figure 2-7) 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 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, 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.

Cal Step Button

Figure 2-7 CAL STEP Button

Press the SYS/DIAS button to toggle between CPP, ICP, ICT and SYS, ICP, DIAS displays (Figure 2-8).

Figure 2-8 SYS/DIAS Display

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9.

Press the TREND button to display the mean ICP and CPP value recorded during the preceding 12 hours (Figure 2-9). With the next press of the trend button, the mean ICP and CPP for the preceding 24 hours will be displayed (Figure 2-10). Press again to return to the pressure display. To clear trend, turn the Camino off momentarily.

Figure 2-9 12 Hour Trend

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. NOTE - ICT and CPP values will ONLY be displayed 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.

Figure 2-10 24 Hour Trend

TO DISPLAY THE CAMINO SOFTWARE VERSION • Make sure that the Camino is powered off. • Connect the Pre-Amp cable. • Insert a catheter to Pre-Amp cable. • Press and hold the DOWN button. • While keeping the DOWN button depressed, power on the Camino by pressing the START/STOP button. • Hold the DOWN button until the SOFTWARE VERSION appears on the screen (Figure 2-11). • Wait approximately 5 seconds for the graph screen to appear.

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Figure 2-11- Software Version Display

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TO CHANGE THE GRAPH MODE This feature is available on software version 1.29 and later. •

The graph mode can be either LINE or FILL (Figure 2-12). • The initial default graph mode is FILL. • The graph mode is saved every time Directions: • Make sure the Camino is powered off. • Press and hold 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.

Figure 2-12 Line Graph Mode Display

TO SET HIGH ICP ALARM •

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: • 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 (Figure 2-13). • 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 (Figure 2-14).

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Figure 2-13 High ICP Alarm

Figure 2-14 High ICP Alarm, OFF Mode

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TO SET LOW CPP ALARM This feature is available on software version 1.31 and later. •

•

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.

Figure 2-15 Low CPP Alarm

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 (Figure 215). • 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 (Figure 2-16).

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Figure 2-16 Low CPP Alarm, OFF Mode

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