Camino ICP Monitor Users Manual Rev B Sept 2012

Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Publication Name

Integra Camino ICP Monitor User’s Manual Integra Part Number 60903733 Rev. B Effective Date September 2012 Trademark Acknowledgements

Integra, the Integra logo, and Camino are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Delta-Cal is a trademark of Utah Medical Products, Inc. Sani-Cloth is a registered trademark of Professional Disposables International, Inc. Aptimax, Sealsure, and Sterrad are registered trademarks of Johnson and Johnson. Tyvec is a registered trademark of E.I. duPont. Kimguard and One-Step are registered trademarks of Kimberly-Clark Worldwide, Inc.

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Copyright Information

©2012 Integra LifeSciences Corporation. All rights reserved.  No part of this document may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means-electronic, mechanical, photocopying, recording, or otherwise-without the expressed, written consent of Integra LifeSciences Corporation. Additional copies of this document can be ordered from Integra LifeSciences Corporation. Manufacturer:

Integra LifeSciences(Ireland) Limited IDA Business and Technology Park Sragh, Tullamore, County Offaly, Ireland Distributed by:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA Tel: 1-800-654-2873 (USA only) 1-(609) 275-0500 Fax: 1-609-275-5363 Internet Address: http://www.integralife.com Made in Ireland. Printed in Ireland.

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TABLE OF CONTENTS List of Symbols and Abbreviations Packaging and Label Symbols ...v Software Symbols ... vi List of Abbreviations ... vii

Chapter 1: System Overview Indications for Use / Intended Use ...1 Contraindications ...1 Intended User...1 Intended Patient Population ...1 Description of the Integra Camino ICP Monitor...2 Key Functions of Monitor...2 Reviewing the User’s Manual...2 List of Warnings for Using the Monitor ...3 Parts of the Monitor ...6 About the Front Panel...6 About the Rear Panel ...7 About the Right Panel...8 About the Bottom Panel...9 About the Left Panel ...9

Chapter 2: Setting Up System for the First Time Procedures for Initial Setup ...11

Chapter 3: Setting Up System for Clinical Use Setting Up System for Clinical Use ...19 Positioning the Monitor ...19 Attaching to Equipment Pole (if applicable) ...19 Powering the System On and Off ...20 Using the Battery for Power...21 Storing the Battery...22 About the Integra Catheters ...23 Connecting the Integra® Camino® Fiber Optic Catheters (110-4 Series) ...24 Connecting the Integra® Camino® Flex Catheters ...27 Connecting to a Patient Bedside Monitor (if applicable) ...30

i

Procedures for Synchronizing the Two Monitors ... 30 About Pressure and Temperature Measurements on the Patient Bedside Monitor... 33 Storing the System ... 33

Chapter 4: Monitoring the Patient’s ICP and Temperature About the Touch Screen... 35 About the Synchronize to Monitor Button ... 36 Reviewing the Status Bar... 36 Verifying Status of Battery and AC Power ... 36 Verifying Amount of Battery Charge Available... 37 About the Alarms ... 37 Monitoring the Patient’s ICP and Temperature ... 37 Monitoring Trend Data ... 39 Conditions that Reset Trend Data... 40 Setting the High ICP Alarm Limit ... 41 Specifying the High ICP Alarm Limit ... 42 Disabling the High ICP Alarm ... 43 Silencing the High ICP Alarm Temporarily... 43 Restoring Default High ICP Alarm Limit Values... 43 Customizing the User Settings ... 44

Chapter 5: Responding to Physiological and Technical Alarms About the Two Alarm Types ... 47 About the Technical Messages ... 47 Understanding the Alarm Symbols ... 48 How the Monitor Prioritizes the Alarms ... 48 Audio and Visual Indicators for Medium and Low Priority Alarms ... 49 Priorities of Physiological and Technical Alarms ... 49 List of Priorities for Each Alarm... 50 Responding to the Physiological Alarm (ICP above alarm limit) ... 51 Responding to Technical Alarms ... 51 Responding to Irreversible System Failure Alarms... 51 Responding to ICP Catheter Failure Alarm... 52 Responding to Temperature Sensor Failure Alarm ... 52 Responding to Low Battery Alarm ... 52 Responding to Monitor Overheating Alarm... 53 Responding to Cooling Fan Failure Alarm ... 53 Responding to Accuracy Range Alarm ... 54 Responding to Battery Failure Alarm ... 55

ii

Chapter 6: Extracting Trend Data for Remote Evaluation About Data Extraction ...57 Extracting Data to USB Drive ...57 How the Monitor Stores Trend Data for Up to 5 Days ...58 Extract Data via Digital Streaming ...59 Conditions That Reset Trend Data During Recording...59

Chapter 7: Cleaning and Sterilizing the System Cleaning the System and Components...61 Cleaning Guidelines ...61 Sterilizing the Integra® Camino® Fiber Optic Catheter Cable ...63 Sterilizing the Integra® Camino® Flex Extension Cable ...65 Sterilization Parameters ...65 About Single-Use Only Catheters ...66 Disposal of the Monitor System and Components ...66

Chapter 8: Troubleshooting the System About the Troubleshooting Process ...67 Responding to System Status Messages ...67 Responding to Problems During Use ...69 Responding to System Failure Messages...73

Chapter 9: Testing and Preventive Maintenance About These Procedures ...75 Use Fiber Optic Catheters for Each Test...75 Testing Pressure Input ...76 Using a Graduated Drainage Bag ...76 Using a Pressure Simulator (preferred method) ...78 Testing Pressure Output ...79 Testing Temperature Input ...80 Testing Temperature Output ...81 Testing High ICP Alarm Limit ...84 Testing AC Power and Battery Charge ...85 AC Power ...85 Low Battery Alarm ...85 Battery Charge ...86 Inserting A New Battery ...86 Determining Software Version ...87

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Testing Synchronizing to Patient Bedside Monitor ... 87

Chapter 10: Contacting Integra for Technical Support and Annual Maintenance About Technical Support ... 89 About Annual Maintenance ... 89

Appendix A: Technical Specifications List of Technical Specifications ... 91 Classifications and Standards ... 93 Manufacturer’s Declaration Table... 94 General Notes... 94

Appendix B: Integra Warranty Warranty ... 99

Index ... 103

iv

LIST OF SYMBOLS AND ABBREVIATIONS

Packaging and Label Symbols Symbol

Definition

Symbol

Definition

Follow instructions for use

Defibrillation-proof type CF applied part

Catalogue number

Direct current

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Class II equipment

Serial number

Waste Electronics and Electrical Equipment

Batch code

USB connection

Manufacturer

Safety information for transporting lithium ion batteries.

Date of manufacture

CALIBRATION VERIFIED. NEXT SCHEDULED MAINTENANCE DUE

Due date for annual maintenance

72903759 Rev 1

+50°C

l

Temperature limitation

-20°C

List of Symbols and Abbreviations • v

Software Symbols

Symbol

Description

Symbol

Definition

Active alarm

AC power not being used/available

Audio paused

Battery charge indicator

Inactive alarm

No battery connected or faulty battery

High ICP alarm limit

Battery being charged

AC power being used

System information panel

On/Off power

vi • List of Symbols and Abbreviations

List of Abbreviations Abbreviation

Definition

AC

Alternating Current

ºC

Celsius

CAMCABL

Preamplification cable used with Integra fiber optic catheters

CSV

Comma-separated values

CT

Computer tomography

dB

Decibels

DC

Direct Current

DMM

Digital Multimeter

EtO

Ethylene oxide

ºF

Fahrenheit

FLEX

Flex Catheter

FLEXEXT

Flex Extension Cable

hPA

Hectopascal pressure unit

ICP

Intracranial pressure

ICT

Intracranial temperature

IPA

Isopropyl alcohol

LED

Light Emmitting Diode

mm

Millimeters

mmHg

Millimeters of mercury

MR

Magnetic resonance

OR

Operating Room

PMIO

Patient Monitor Input Output

TBI

Traumatic brain injury

USB

Universal Serial Bus

V

Volt

W

Watt

List of Symbols and Abbreviations • vii

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viii • List of Symbols and Abbreviations

CHAPTER 1

SYSTEM OVERVIEW Indications for Use / Intended Use ... 1 Contraindications ... 1 Intended User... 1 Intended Patient Population ... 1 Description of the Integra Camino ICP Monitor ... 2 Reviewing the User’s Manual ... 2 List of Warnings for Using the Monitor ... 3 Parts of the Monitor ... 6

Indications for Use / Intended Use The Integra® Camino® ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.

Contraindications The Integra Camino ICP Monitor and its accessories are contraindicated for use in a Magnetic Resonance (MR) environment.

Intended User The Integra Camino ICP Monitor is intended to be used by the following qualified medical and biomedical professionals: •

A qualified neurosurgeon should perform the placement and handling of the catheters.

•

Designated qualified hospital staff (e.g. neurosurgeon, nurse, intensivist, trauma physician, or physician’s assistant) should perform the operation of the monitor.

Chapter 9 provides instructions for testing and maintaining the monitor. The procedures in this chapter are intended to be performed by the hospital’s biomedical engineering staff.

Intended Patient Population Patients undergoing treatment with this monitor under the cranial applications are expected to have had a TBI, undergone a major neurosurgical procedure, or some other traumatic, ischemic or hemorrhagic incident requiring controlled monitoring of ICP and brain temperature.

Chapter 1 • System Overview • 1

Description of the Integra Camino ICP Monitor The Integra Camino ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports the following catheters: •

Series of Integra® Camino® Fiber Optic Catheters (110-4 series) for measuring both ICP and temperature.

•

Integra® Camino® Flex Catheter for measuring ICP values.

All Integra catheters measure their respective values at the tip of the catheter. This design eliminates the need for a fluid-filled system to communicate pressure (and carry pressure waves) to an external transducer. Key Functions of Monitor During clinical use, the Integra Camino ICP Monitor provides several key functions to facilitate the process for monitoring and analyzing patient data: •

Touch screen interface for evaluating patient ICP/ICT data and setting patient parameters (see page 35)

•

Physiological alarm that activates if the patient’s Mean ICP value exceeds a user-specified limit for more than 5 seconds (see page 41)

•

Rechargeable lithium ion battery that supplies power to monitor during patient transport (see page 21)

•

Storage of patient’s ICP trend data for up to 5 days (see page 39)

•

Outputs for transferring patient data to a patient bedside monitor (see page 30)

•

Outputs for extracting patient data to remote media types via USB drive or digital streaming (see page 57)

For instructions on using the Integra catheters, see the directions for use supplied with each respective catheter.

Reviewing the User’s Manual Integra recommends that all physicians, nurses, and technicians who will be using, operating, and maintaining the Integra Camino ICP Monitor review this user’s manual prior to using the system. If there are additional questions after reading this manual, contact Integra.

2 • Chapter 1 • System Overview

List of Warnings for Using the Monitor Failure to observe one or more of the following warnings could compromise patient safety or result in measurement errors. Warnings • Use of the Integra Camino ICP Monitor is restricted to one patient at a time. • The Integra Camino ICP Monitor and its accessories are contraindicated for use in a Magnetic Resonance (MR) environment. • Always verify the high ICP alarm limit is set appropriately for each patient prior to treatment. • Selecting the Alarm Off feature on the Alarm panel will disable the high ICP alarm limit indefinitely. Use caution if this feature is selected. To re-enable this alarm, press the Alarm On and Accept buttons. • No modification of the Integra Camino ICP Monitor is allowed. • The Integra Camino ICP Monitor is a sensitive electronic device. When using the monitor, always handle with care. If damage is suspected, contact Integra. • Read the user’s manual from the patient bedside monitor’s manufacturer before connecting the Integra Camino ICP Monitor to a patient bedside monitor. • To prevent injury to the patient, user, or other persons, or damage to the monitor, always verify that the monitor is clamped securely to the equipment pole. • To reduce the risk of electric shock, do not disassemble the Integra Camino ICP Monitor. Refer all servicing to qualified service personnel at Integra. • To prevent electrical shock, only use the AC power adapter supplied by Integra (REF # MONPWR). Using a different AC power adapter may not provide protection against electric shock. • Danger - Possible explosion hazard if used in the presence of flammable anaesthetics. • Only use Integra supplied accessories on the Integra Camino ICP Monitor. This applies in particular to catheters, catheter cables, battery, AC power adapter, and USB-to-R232 adapter cable. • If the Integra Camino ICP Monitor loses power and shuts down while it is connected to a patient bedside monitor, do not use the ICP values on the patient bedside monitor for patient measurements; the ICP values on the patient bedside monitor will be invalid. • Connect the monitor to an AC power supply immediately if the low battery alarm is activated.

Chapter 1 • System Overview • 3

Warnings • When using the battery: -

Do not heat above 80 °C.

-

Do not open battery.

-

Do not dispose of in fire.

-

Do not short circuit as battery may ignite, explode, leak, or get hot causing personal injury.

-

Replace battery with same part number only (REF # BAT1001).

-

Use of another battery may present a risk of fire or explosion.

• To prevent injury to the patient, user, or other persons, make sure that the battery cover is closed securely during monitor use. • Do not connect an Integra Camino Fiber Optic Catheter and an Integra Camino Flex Catheter simultaneously to the monitor. The Integra Camino ICP Monitor is designed to report ICP measurements with either the Flex Catheter or Fiber Optic Catheter connected to the monitor, but not both together. • To prevent possible patient injury resulting from incorrect ICP measurements, always perform the steps listed on page 23 before implanting a new Integra Camino Fiber Optic Catheter into the patient. In particular, always make sure to adjust the new Fiber Optic Catheter’s ICP value to zero before implantation while the catheter is in the air. Never attempt to re-zero a catheter while the catheter is inside the patient. • Once the Integra Camino Fiber Optic Catheter has been zeroed to the Integra Camino ICP Monitor, do not replace the Fiber Optic Catheter Cable being used for patient measurement. Replacing the Fiber Optic Catheter Cable with another cable after the catheter has already been zeroed may result in inaccurate patient measurements. • Once the Integra Camino Fiber Optic Catheter has been zeroed to the Integra Camino ICP Monitor, do not transfer this zeroed catheter to any other monitor. Transferring a zeroed catheter to a different monitor may result in inaccurate ICP measurements. • To prevent possible patient injury resulting from incorrect ICP measurements, always perform each of the steps listed on page 26 before implanting a new Integra Camino Flex Catheter into the patient. In particular, always leave the Flex Catheter in the air until the monitor completes the autozero (i.e. initialization) process successfully. • Once the Integra Camino Flex Catheter has been initialized (autozeroed) by the Integra Camino ICP Monitor, do not replace the Integra Camino Flex Extension Cable being used for patient measurement. Replacing the Flex Extension Cable with another cable after the Flex Catheter has already been initialized may result in inaccurate ICP measurements. • Once the Integra Camino Flex Catheter has been initialized (i.e. autozeroed) by the Integra Camino ICP Monitor, do not transfer this initialized catheter to any other monitor. Transferring an initialized catheter to a different monitor may result in inaccurate ICP measurements.

4 • Chapter 1 • System Overview

Warnings • The Integra Camino ICP Monitor will only store the Mean ICP data from the most recent 5 days. All stored trend data older than 5 days will be lost. If monitoring is continued for more than 5 days, placement of a new catheter under sterile conditions is recommended. Note that replacing a catheter will reset the trend data. Please extract any data that you wish to retain prior to replacing the catheter. • Do not autoclave or immerse the Integra Camino ICP Monitor in liquid as damage may occur. If the monitor is exposed to liquids, turn off the unit, remove the AC power adapter, dry the unit thoroughly, and send to biomed staff for evaluation before reapplying power. • Only use the cleaning agents listed in Chapter 7 for cleaning and disinfecting the Integra Camino ICP Monitor system. Using solvents or cleaning agents not listed in Chapter 7 may damage the plastic exterior of the Integra Camino ICP Monitor.

Chapter 1 • System Overview • 5

Parts of the Monitor The Integra Camino ICP Monitor contains hardware, software, and electrical components that support specific Integra catheters for monitoring the patient’s ICP and temperature. The following section provides information on the different parts of the monitor. About the Front Panel

1

2 3

4

The front panel contains:

6 • Chapter 1 • System Overview

Number

Item

Description

1

Handle

Handle used for carrying the monitor.

2

Power Status

Green LED button that indicates the monitor is being powered by the AC power adapter. Note that this button does not illuminate if the monitor is being powered by the battery.

3

Power Button

Turns the monitor on and off. This button is illuminated when the power is on.

4

Touch Screen

Provides software tools for viewing data and controlling parameters for monitoring the patient’s ICP and ICT levels.

About the Rear Panel

1 5

2 6

3 4

The rear panel contains: Number

Item

Description

1

USB Port

Connection port for extracting trend data via USB transfer or digital streaming.

2

AC Power Adapter Port

Connection port for the AC power cord.

3

PMIO Port

Connection port for PMIO cable. This cable is used to connect the Integra Camino ICP Monitor to a patient bedside monitor.

4

Pole Clamp

Clamping system for securing monitor to an equipment pole.

5

Air Vent

Grated opening that allows air being circulated by the internal cooling fan to leave the monitor.

6

Cable Strap

Rubber strap used to secure AC power adapter during transport.

Chapter 1 • System Overview • 7

About the Right Panel

1 2

3

The right panel contains: Number

8 • Chapter 1 • System Overview

Item

Description

1

Temperature Port

Connection port for the temperature connector on the Fiber Optic Catheter Cable.

2

Pressure Port

Connection port for the ICP connector on the Integra Camino Flex Extension Cable (pressure only).

3

Pressure Port

Connection port for the ICP connector on the Fiber Optic Catheter Cable.

About the Bottom Panel

1

2

The bottom panel contains: Number

Item

Description

1

Battery Door Cover

Removable cover for accessing/replacing the 14.4V lithium ion battery.

2

Air Vent

Grated opening that allows air being circulated by the internal cooling fan to leave the monitor.

About the Left Panel The left panel does not contain any usable connector ports or buttons.

Chapter 1 • System Overview • 9