natus Camino ICP User manual

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Camino
®
ICP Monitor
Intracranial Pressure and Temperature Monitor
User’s Manual
025870 Rev 00 (01/2019)

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Caution
Federal (USA) law restricts this device tosale by or on the order of a physician.
Caution
Trademark Acknowledgements
Natus, Natus Neuro, the Natus Neuro logo, and Camino are registered trademarks of Natus Medical Incorporated or i t s subsidiaries in the
United
S t a t es and/or other countries. Delta-Cal is a trademark of Utah Medical P r oducts, Inc. S a ni-Cloth is a registered trademark of
Professional Disposables International, Inc. Aptimax, Sealsure, and S t e rr a d are registered tr a d ema r ks of J ohn son and J ohn son . Tyvec is a
registered trademark of E.I. du P o nt. Kimguard and One - S t ep are registered trademarks of Kimberly-Clark Worldwide, In c .
Copyright Information
©2018 Natus Medical Incorporated. All rights reserved.
No p a r t of thi s docu men t may be reproduced, stored in a retrieval s yst e m , or tr ansmit t e d, in any form or by any means—electronic,
mechanical, photocopying, recording, or otherwise—without the expressed, writ t e n c o nsen t of Natus Medical Incorporated. Additional
copies
of this document can be ordered from Natus Medical Incorporated .
Natus Medical Incorporated
5955 Pacific Center Blvd
San Diego, CA 92121 – USA
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
Printed 01-2019

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Contact Information
If the Camino ICP Monitor fails to perform as specified, and the c a u se c a nno t be determined, do not use or a t te mp t to repair i t . Instead,
c
on t a c t Natus Neuro for t e chnic a l servic e:
Domestic
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
1-800-356-0007
[e-mail]
International
Natus Europe GmbH
Phone: [phone]
Fax: [phone]
[e-mail]
For service and repairs outside the United
S t at e s , c on t act your local a u thoriz e d Natus Neuro r e pr esentativ e.

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Contents
Trademark Acknowledgements ..................................................................................................................................................................3
Copyright Information .................................................................................................................................................................................3
Contact Information ........................................................................................................................................................................................4
List of Symbols and Abbreviations ...........................................................................................................................................................12
Packaging and Label Symbols .............................................................................................................................................................13
Software Symbols.................................................................................................................................................................................14
List of Abbreviations .............................................................................................................................................................................15
CHAPTER 1 - System Overview ............................................................................................................................................................17
Indications for Use / Intended Use............................................................................................................................................................17
Contraindications......................................................................................................................................................................................17
Intended User ...........................................................................................................................................................................................17
Intended Patient Population......................................................................................................................................................................17
Description of the Camino ICP Monitor.....................................................................................................................................................18
Key Functions of Monitor ..........................................................................................................................................................................18
Reviewing the User’s Manual ...................................................................................................................................................................18
List of Warnings for Using the Monitor ......................................................................................................................................................19
Parts of the Monitor ..................................................................................................................................................................................22
About the Front Panel...........................................................................................................................................................................22
About the Rear Panel ...........................................................................................................................................................................23
About the Right Panel...........................................................................................................................................................................24
About the Bottom Panel........................................................................................................................................................................25
About the Left Panel .............................................................................................................................................................................26

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CHAPTER 2 – Setting up the system for the first time .......................................................................................................................27
Procedures for Initial Setup ......................................................................................................................................................................27
Step 1: Unpack the System (REF # CAM02) ..................................................................................................................................27
Step 2: Install the Battery ................................................................................................................................................................29
Step 3: Prepare the AC Power Adapter with Region-Specific Plug .................................................................................................30
Step 4: Plug the Monitor into AC Power..........................................................................................................................................32
Step 5: Set the Time and Date........................................................................................................................................................33
Step 6: Specify the Language.........................................................................................................................................................33
Step 7: Use AC Power to Charge the Battery to Full Capacity ........................................................................................................34
CHAPTER 3 – Setting up the system for clinical use 35
Setting Up the System for Clinical Use.................................................................................................................................................35
Positioning the Monitor .........................................................................................................................................................................35
Attaching to Equipment Pole (if applicable)......................................................................................................................................36
Powering the System On and Off .........................................................................................................................................................37
Turning On the System ....................................................................................................................................................................37
Turning Off the System ....................................................................................................................................................................38
Using the Battery for Power..................................................................................................................................................................38
Battery Power Indicator ........................................................................................................................................................................39
Storing the Battery................................................................................................................................................................................40
About the Natus Neuro Catheters ............................................................................................................................................................41
Connecting the CaminoFiber Optic Catheters (110-4 Series)..................................................................................................................42
Connecting the Camino Flex Catheters....................................................................................................................................................46
Transient Pressure Changes During Implantation or Removal of Catheter May Trigger Alarm .......................................................49
Connecting to a Patient Bedside Monitor (if applicable)............................................................................................................................50
Procedures for Synchronizing the Two Monitors...................................................................................................................................51
About Pressure and Temperature Measurements on the Patient Bedside Monitor ...............................................................................54
Storing the System....................................................................................................................................................................................55
Using the Cable Strap to Wrap the AC Power Adapter....................................................................................................................55

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CHAPTER 4 – Monitoring the patient’s ICP and Temperature ...........................................................................................................57
About the Touch Screen............................................................................................................................................................................57
About the Synchronize to Monitor Button .............................................................................................................................................58
Reviewing the Status Bar......................................................................................................................................................................58
Verifying Status of Battery and AC Power.............................................................................................................................................58
Verifying Amount of Battery Charge Available ......................................................................................................................................59
About the Alarms ......................................................................................................................................................................................59
Monitoring the Patient’s ICP and Temperature..........................................................................................................................................60
About the Numerical Display of Mean ICP Values ...........................................................................................................................61
Scaling the ICP Waveform Ranges..................................................................................................................................................61
Monitoring Trend Data...............................................................................................................................................................................62
Scaling Time Ranges for Trend Data ...............................................................................................................................................63
Scaling the ICP Ranges for Trend Data ...........................................................................................................................................63
Conditions that Reset Trend Data.........................................................................................................................................................63
Setting the High ICP Alarm Limit ..............................................................................................................................................................64
About the High ICP Alarm Limit Calculation.....................................................................................................................................65
Specifying the High ICP Alarm Limit .....................................................................................................................................................66
Touch Screen Labels Indicating High ICP Alarm Limit.....................................................................................................................67
Disabling the High ICP Alarm ...............................................................................................................................................................68
Silencing the High ICP Alarm Temporarily............................................................................................................................................68
Restoring Default High ICP Alarm Limit Values ....................................................................................................................................68
Customizing the User Settings..................................................................................................................................................................69
Specifying Waveform Type ...................................................................................................................................................................70
Specifying Time and Date.....................................................................................................................................................................71
Specifying Languages ..........................................................................................................................................................................72
Determining System Information ..........................................................................................................................................................73
About Extract Log and Service Mode Buttons......................................................................................................................................73

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CHAPTER 5 – Responding to physiological and technical alarms ...................................................................................................75
About the two alarm types.........................................................................................................................................................................75
About the Technical Messages .................................................................................................................................................................75
Understanding the Alarm Symbols ...........................................................................................................................................................76
How the Monitor Prioritizes the Alarms.....................................................................................................................................................77
Audio and Visual Indicators for Medium and Low Priority Alarms .........................................................................................................77
Priorities of Physiological and Technical Alarms...................................................................................................................................78
How the Monitor Prioritizes Between Two Technical Alarms............................................................................................................78
List of Priorities for Each Alarm ............................................................................................................................................................79
Responding to the Physiological Alarm (ICP above alarm limit) ...............................................................................................................80
Responding to Technical Alarms...............................................................................................................................................................81
Responding to Irreversible System Failure Alarms ...............................................................................................................................81
Responding to ICP Catheter Failure Alarm...........................................................................................................................................81
Silencing the Catheter Failure Alarm Temporarily............................................................................................................................81
Responding to Temperature Sensor Failure Alarm ...............................................................................................................................82
Silencing the Catheter Failure Alarm Temporarily............................................................................................................................82
Responding to Low Battery Alarm ........................................................................................................................................................82
15 Minutes or Less of Remaining Power..........................................................................................................................................82
5 Minutes or Less of Remaining Power............................................................................................................................................83
Silencing the Low Battery Alarm Temporarily ..................................................................................................................................83
Responding to Monitor Overheating Alarm...........................................................................................................................................84
Silencing the Monitor Overheating Alarm Temporarily .....................................................................................................................84
Responding to Cooling Fan Failure Alarm ............................................................................................................................................84
Silencing the Cooling Fan Alarm Temporarily ..................................................................................................................................84
Responding to Accuracy Range Alarm .................................................................................................................................................85
Silencing the ICP and Temperature Accuracy Range Alarm Temporarily........................................................................................85
Responding to Battery Failure Alarm ....................................................................................................................................................86
Silencing the Battery Failure Alarm Temporarily ..................................................................................................................................86

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CHAPTER 6 – Extracting trend data for remote evaluation ...............................................................................................................87
About Data Extraction...............................................................................................................................................................................87
Extracting Data to USB Drive ...................................................................................................................................................................88
How the Monitor Stores Trend Data for Up to 5 Days ...........................................................................................................................89
Extract Data via Digital Streaming ............................................................................................................................................................90
Conditions That Reset Trend Data During Recording ...............................................................................................................................91
CHAPTER 7 – Cleaning and Sterilizing the System............................................................................................................................93
Cleaning the System and Components.....................................................................................................................................................93
Cleaning Guidelines .............................................................................................................................................................................94
Sterilizing the Camino Fiber Optic Catheter Cable ...................................................................................................................................96
Limits on Sterilization............................................................................................................................................................................96
Sterilization Parameters .......................................................................................................................................................................96
Sterilization cycle parameters for the fiber optic cable.........................................................................................................................97
Following Sterilization ......................................................................................................................................................................97
Sterilizing the Camino Flex Extension Cable ............................................................................................................................................97
Limits on Sterilization............................................................................................................................................................................97
Sterilization Parameters .......................................................................................................................................................................97
Steam Pre-Vacuum Sterilization Parameters ...................................................................................................................................98
Following Sterilization...........................................................................................................................................................................98
Containment and Transportation of Sterilized Cables.......................................................................................................................98
Storage of Sterilized Cables.............................................................................................................................................................98
About Single-Use Only Catheters .............................................................................................................................................................99
Disposal of the Monitor System and Components ....................................................................................................................................99

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CHAPTER 8 – Troubleshooting the system.......................................................................................................................................101
About the Troubleshooting Process ........................................................................................................................................................101
Responding to System Status Messages ...............................................................................................................................................101
Responding to Problems During Use......................................................................................................................................................104
Responding to System Failure Messages ..............................................................................................................................................109
CHAPTER 9 – Testing and Preventative Maintenance......................................................................................................................111
About These Procedures........................................................................................................................................................................111
Use Fiber Optic Catheters for Each Test ............................................................................................................................................111
Testing Pressure Input ............................................................................................................................................................................112
Using a Graduated Drainage Bag.......................................................................................................................................................112
Using a Pressure Simulator (preferred method) .................................................................................................................................116
Testing Pressure Output .........................................................................................................................................................................118
Testing Temperature Input ......................................................................................................................................................................119
Temperature Transducer Connector Test Circuit Diagram..................................................................................................................120
Testing Temperature Output ...................................................................................................................................................................121
Testing High ICP Alarm Limit ..................................................................................................................................................................124
Testing AC Power and Battery Charge ...................................................................................................................................................126
AC Power ...........................................................................................................................................................................................126
Low Battery Alarm ..............................................................................................................................................................................127
Battery Charge ...................................................................................................................................................................................128
Inserting a New Battery ..........................................................................................................................................................................129
Determining Software Version.................................................................................................................................................................130
Testing Synchronizing to Patient Bedside Monitor ..................................................................................................................................130
CHAPTER 10 – Contacting Natus Neuro for Technical Support and Annual Maintenance ..........................................................131
About Technical Support .........................................................................................................................................................................131
About Annual Maintenance.....................................................................................................................................................................132

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APPENDIX A – Technical Specifications ...........................................................................................................................................133
List of Technical Specifications ...............................................................................................................................................................133
Classifications and Standards.................................................................................................................................................................135
Manufacturer’s Declaration Table ...........................................................................................................................................................136
General Notes ....................................................................................................................................................................................136
APPENDIX B - Natus Medical Incorporated Warranty ......................................................................................................................143

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List of Symbols and Abbreviations
Packaging and Label Symbols
Symbol Definition Symbol Definition
F o llow instructions for use Defibrillation-proof t y pe CF applied part
Catalog number Direct current
Cau t ion: Federal (USA) law restricts this device to
sale by or on the order of a ph ysician .
Class II equipment
Serial number Waste Electronics and Ele c trical
E q uipment
B a t c h cod e USB conn e c t i on
Manufacturer S af e t y information for tr ansporting lithium
ion
b a tt eries.
D a t e of manuf a ct ur e
C A LI B R A T IO N
VERIFIED .
NEXT SCHEDULED
MAINTENANCE DUE
72903759 Rev 1
Due date for annual main t e nanc e
Temperature limitation ETL Certification
INMETRO Ce rtificat ion
Do not reuse.
European Authorized Representative Not made with natural rubber latex
Consult Instructions for Use

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Software Symbols
Symbol Description
Symbol Definition
Active alarm On/Off power
Audio paused AC power not being used/ a v a ilable
Inactive alarm B a tt e ry charge indicator
Alarm Off No bat t ery connected or faulty battery
High ICP alarm limit B at t e ry being charged
AC power being used System information panel

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List of Abbreviations
Abbreviation
Definition
A C
Alternating C u rr ent
º
C
Ce l s i u s
CAMCABL
P r e amplification cable used with Natus fiber optic c a t h e t e r s
CS V
Comma-separated values
CT
Computer tomography
dB
Decibels
DC
Direct C u rr ent
DMM
Digital Multimeter
E t O
E th ylene o x id e
º
F
F ah r e nheit
FLEX
Flex Ca thet er
F L EXEX T
Flex E x t e ns io n Cable
hPA
Hectopascal pressure unit
ICP
In t r a cr anial p r ess ur e
ICT
Intracranial t e mper atur e
IP A
Isopropyl alcohol
LED
Light E m mi t ti ng Diode
mm
M ill imeter s
mmHg
Millimeters of mercury
MR
Magne t ic resonance
O R
Operating R oom
PMIO
P a tient Monitor Input Output
TBI
Traumatic brain injury
USB
Universal Serial Bus
V
V o l t
W
W a tt

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CHAPTER 1 - System Overview
Indications for Use / Intended Use
The Camino ICP Monitor is indicated foruse by qualified neur os ur geons or ne uroin t en sivists for me a s ur e m en t of
intracranial pressure and t e mper a t ur e.
Contraindications
The Camino ICP Monitor and i t s accessories are con t r a i nd i c a te d foruse in a Magnetic Resonance (MR)
environment.
Intended User
The Camino ICP Monitor is intended to be used by t h e following qu a li f i e d medical and biomedical pr of es sionals:
• A qualified physician should perform the placement and handling of the ca thet er s.
• Designated qualified hospital staff (e.g. neurosurgeon, nurse, int e n sivis t , trauma physician, or physician’s
assistant) should perform the operation
of the monit o r .
Chapter 9 provides instructions for t e sti ng and maintaining the monitor. The procedures in thi s chapter are
i n t e nded to be performed by the hospital’ s biomedical engineering staff .
Intended Patient Population
Patients undergoing t r eatm en t with this monitor under the cranial applications ar e 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 t e mper atur e.

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Description of the Camino ICP Monitor
The Camino ICP Monitor is a compact, por t able device that provides tools for continuously determining and
moni t oring intracranial pressure (ICP) and intracranial t e mper a t ur e (ICT) directly in the brain, depending on which
cathe t er s are connected to the system. This monitor supports t h e following ca the t er s:
• S e r i e s of Ca m i no Fiber Optic Catheters ( 1 10- 4 series) for measuring both ICP and t e mper atur e.
• Camino Flex Catheter for measuring ICP v a lues.
All Natus Neuro catheters measure their respective values at the tip of the catheter. This design elimina t es the
need
for a fluid-filled system to communicate pressure (a nd carry pressure waves) to an external tr ansduc e r .
Key Functions of Monitor
During clinical use, the Camino ICP Monitor provides several key functions to fa c ili t a te t h e process for mon i t o ring
and analyzing patient data:
• Touch screen interface for evaluating patient ICP / ICT data and set t ing patient parameters.
• Physiological alarm that activates if the patient’s Mean ICP value exceeds a user-specified limit for more than 5
seconds.
• Rechargeable lithium ion bat t ery that supplies power to monitor during patient transport .
• S t or age of patient’s ICP trend data for up to 5 days.
• Outputs for transferring patient data to a patient bedside monitor .
• Outputs for extracting patient data to remote media t ypes via USB drive or digital streaming .
For instructions on using the Natus Neuro catheters, see the directions foruse s upplied with each r e spe c t i v e
ca
the t er .
Reviewing the User’s Manual
Natus Neuro recommends that all physicians, nurses, and t e chnici ans who will be using, operating, and
maintaining the
Camino ICP Monitor review this user ’ s manual prior to using the system. If there are
additional questions after
r ea ding this manual, c on t ac t Natus Neuro .

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List of Warnings for Using the Monitor
Failure to observe one or more of the following warnings could c ompr omise patient saf e t y or result in
measurement erro r s .
Warnings
•Use ofthe Camino ICP Monitor is restricted to one patient at a time.
•
The Camino ICP Monitor and its accessories are contraindicated for use in a Magne t ic Resonance (MR)
environment.
•Always verify the high ICP alarm limit
is set appropriately for each patient prior t o tr eatment .
•
S electing the Alarm Off feature on the Alarm panel will disable t h e high ICP alarm limit indefinitely. Use caution if
t h is feature is selected. To re-enable this alarm, pr ess the Alarm On and Accept buttons.
•
No modification of the Camino ICP Monitor is allowed.
•The Camino ICP
Monitor is a sensitive electronic device. When using the monitor, always handle with care. If
damage is suspected, contact Natus Neuro .
•Read the user’s manual from the patient bedside monitor’s manufacturer b e f o r e connecting the Camino ICP
Monitor to a patient bedside monit o r .
•
To p r even t injury to the p a ti en t , user, or o t her persons, or damage to the monitor, always verify that the monitor
is clamped securely
to the equipment pole.
•
To p r even t injury to the p a ti en t , user, or o t her persons, or damage to the monitor, make sure to position the cables
so that they are free from all foot traffic.
•
Care should be taken if the equipment is used adjacent to or stacked with other equipment; if adjacent or stacked
use is inevitable, the equipment should be
obser v e d to verify normal operation in the c o nfigur a t io n in which it will
be used.
• Do not block the alarm speaker with any materials that might muffle the alarm sound.
•
To reduce t h e risk of electric shock, do notdisassemble the Camino I C P Monitor. R e f e r all servicing to qualified
service personnel at
Natus Neuro .

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• To prevent electrical shock, only use the AC power adapter supplied by Natus Neuro (REF # 025430). Using a
different AC power adapter may not provide protection against electric shock.
•
To reduce t h e risk of electric shock, only connect to IEC 6060 1 certified bedside monit o r s .
•
Danger - Possible explosion hazard if used in the presence of flammable anesthe tics. Not suitable for use in the
presence
of flammable anesthetics mix t ur ewith air, oxygen, or nitrous o x id e.
•
Only use Natus Neuro supplied accessories on the Camino ICP Monitor. This applie s in particular to catheters,
catheter cables,
bat t e r y , AC power adapter, and USB-to-R232 adapter cable.
•If
the Camino ICP Monit o r loses power and shu t s down while it is connected t o a patient bedside mo ni t o r , do not
use the ICP values on
t h e p a tie n t bedside monitor for patient measurements; the ICP values on the patient
bedside monitor
will be in v a lid.
• Connect the monitor to an AC power supply immediately if the low bat t e r y alarm is activ a t e d.
•
When using the bat t e r y:
- Do not heat above 80 °C.
-
Do not open bat t ery .
-
Do not dispose of in fir e.
-
Do not sho r t ci r c ui t as bat t ery may ignite, explode, leak, or g e t hot caus ing personal injury .
-
Replace b a tt ery with same part number only (REF # 026950 ).
-
Use of another bat t ery may pr esen t a risk of fire or explosion.
• To prevent injury to the patient, useror other persons, make sure that the battery cover is closed securely during
monitor
use.
•
Do not connect a Camino Fiber Optic Catheter and an Camino Flex Catheter simultaneously to the mon i t o r .
The 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 t ogether .
• To prevent possible patient injury resulting from incorrect ICP measurements, alw a ys perform the steps in
Chapter 3 before implanting
a new 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 at t e mpt to re-zero a catheter while the catheter is inside the patient.