Hummingbird H110 User manual

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
Instructions for Use
H110
DESCRIPTION:
Hummingbird Parenchymal IntraCranial
Pressure Monitoring Catheter Kit
KIT CONTENTS:
1 Bolted Parenchymal ICP Catheter Kit:
- Parenchymal ICP Monitoring
Catheter
- Bolt with Dilator
- Drill Bit with Collar and Hex
Wrench
1 Skull Thickness Caliper
1 Stab Incision Knife

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
Table of Contents
LIST OF SYMBOLS AND TERMINOLOGY ............................................................................................3
List of Symbols.............................................................................................................................3
SYSTEM OVERVIEW.............................................................................................................................4
Description....................................................................................................................................4
Indications ....................................................................................................................................4
Contraindications.........................................................................................................................5
Intended User ...............................................................................................................................5
Sterility..........................................................................................................................................5
MR Compatibility..........................................................................................................................5
Shipping........................................................................................................................................5
Storage..........................................................................................................................................5
Procedure Preparation.................................................................................................................8
Step 1 –Estimate Skull Thickness and Prepare the Access Site..............................................8
Step 2 –Prepare the Drill Bit Assembly and Drill........................................................................8
Step 3 –Irrigate the Twist Drill Hole............................................................................................9
Step 4 –Incise the Dura ...............................................................................................................9
Step 5 –Measure Skull Thickness.............................................................................................10
Step 6 - Fixation of Bolt..............................................................................................................10
Step 7 –Ensure Incision is Large Enough for Catheter...........................................................10
Step 8a –Aligning the Catheter to the Bolt ..............................................................................11
Step 8b - Insertion of the Catheter into the Bolt.......................................................................11
Step 9 –Access Completed, Zeroing the ICP Monitoring System and Connecting the
Catheter.......................................................................................................................................11
MAINTENANCE OF THE H110 AND BOLT INSERTION SITE.............................................................13
ICP Lumen Connector Maintenance: ........................................................................................13
CATHETER REMOVAL PROCEDURE.................................................................................................13
Step 1 –Disconnect the Patient Cable Module: .......................................................................13
Step 2 –Removal of the Catheter from the Bolt.......................................................................13
Step 3–Removal of the Bolt ......................................................................................................13
Step 4 –Close surgical site .......................................................................................................14
Recommended Manual Cleaning Method.................................................................................14
Recommended Disinfection Agents..........................................................................................14
TROUBLESHOOTING THE SYSTEM ..................................................................................................14
CONTACTING TECHNICAL SUPPORT...............................................................................................15
MR CONDITIONAL INFORMATION.....................................................................................................17
SKULL THICKNESS CALIPER QUICK GUIDE.....................................................................................18
WARNINGS..........................................................................................................................................19
CAUTIONS...........................................................................................................................................20
WARRANTY............................................................................................................................................20
LIMITATIONS OF LIABILITY ..................................................................................................................20
RETURN GOODS POLICY...................................................................................................................21
ORDERING INFORMATION.................................................................................................................21
IRRAS USA, Inc...........................................................................................................................21

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
LIST OF SYMBOLS AND TERMINOLOGY
List of Symbols
Symbol
Meaning
Manufacturer
Refer to the Instructions for Use
Expiration Date expressed as year-month-day (yyyy-mm-dd).
Non-Pyrogenic
Do not reuse after opening
Model number
Lot Number
Sterile unless package is open. Method of sterilization –ethylene oxide.
Temperature limits
Relative humidity limits
Keep dry
General Warning
Federal (USA) law restricts this device to sale by or on the order of a physician.
MR Unsafe
MR Conditional (refer to MR Conditional Information section):
•1.5 Tesla
•3.0 Tesla

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
Terminology
ICP
Intracranial Pressure
ICP Monitoring
System
The system is comprised of the HICP200 and a Hummingbird Catheter (in
the case of this IFU, the Hummingbird Parenchymal ICP Monitoring
Catheter.)
HICP200
The HICP200 is comprised of the Control Module, Patient Cable Module,
Monitor Cable and AC Power Supply.
ICP Lumen
The air lumen that connects the pressure-sensing air bladder to the
pressure transducer located in the Patient Cable Module and provides
communication between the parenchymal ICP monitoring site and the
pressure transducer.
SYSTEM OVERVIEW
Description
The Hummingbird Solo ICP Monitoring device (H110), is an advanced bolted parenchymal ICP
monitoring technology that is designed for accuracy and ease of use. The H110, when used with
HICP200 comprises a system whose principle of operation is based on air-coupled pressure
transduction. The H110 measures ICP with a pressure sensing air bladder located in the
parenchyma. The HICP200 employs air rather than liquid to transduce pressure waves to the
reusable pressure sensor housed in the Patient Cable Module, thus providing for ICP waveform
display and calculation of mean ICP pressure. Refer to the HICP200 Quick Reference Guide
and Instructions For Use (IFU) for operating instructions. The Patient Cable Module requires no
leveling and can be zeroed in-situ. The H110 is packaged in a kit that kit consists of the
following items:
•Parenchymal ICP Monitoring Catheter
•Drill Bit Assembly (consisting of Depth Limiting Collar and 4 mm diameter drill bit) and
hex wrench
•Bolt with Dilator
•Skull Thickness Caliper
•Stab Incision Knife
NOTE: The following required items are not provided by this kit and must be obtained
separately in order to place the H110 and measure ICP:
•A cranial access kit that includes a hand drill
•HICP200 ICP Control Module with the appropriate Monitor Cable for
connection to the patientmonitor
Indications
The H110 is designed for use with HICP200. Together, they comprise a system that is indicated
for use in those conditions where continuous monitoring of ICP is required. The device should
be utilized by a qualified healthcare professional in clinical conditions that warrant direct
measurement of intracranial pressure is clinically important.

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
Contraindications
Invasive ICP monitoring should not be performed where components of the monitoring
system will come into direct contact with any infected tissue. The H110 is contraindicated:
•When the patient is receiving anticoagulants
•When the patient is known to have a bleeding diathesis
•If trained personnel are not available to continuously supervise ICPmonitoring
Intended User
The H110 is intended to be used by trained and experienced medical and biomedical
professionals:
•A qualified healthcare professional should perform the placement and handling
of the ICP catheter.
•Qualified hospital staff (e.g. neurosurgeon, nurse, intensivist, trauma physician, or
physician’s assistant) should oversee ICP monitoring.
f
IRRAS USA, Inc. recommends that all physicians, nurses, and technicians who will be
using, operating, and maintaining the H110, review the IFU prior to
using the system. If there are additional questions after reading this IFU, contact In
IRRAS USA, Inc.
.
Sterility
This product is provided sterile and is for SINGLE USE ONLY. DO NOT RESTERILIZE.
Kit contents are sterile and non-pyrogenic if package is undamaged and unopened. Do
not re-sterilize. For single-use only—Do not reuse. If opened and unused, discard
immediately.
The H110 has not been designed to undergo or withstand any form of alteration, such as
disassembly, cleaning or re-sterilization, after a single patient use. These devices are
intended to come into contact with the central nervous system and the ability does not
currently exist to destroy possible contaminants such as Creutzfeldt-Jakob Disease
agents. Reuse can also compromise device performance characteristics and any usage
beyond the design intent of this single-use device can result in unpredictable use hazards
or loss of functionality.
MR Compatibility
The Hummingbird H10 has been found to be MR conditional at:
• 1.5 Tesla
• 3.0 Tesla
The HICP200 is MR Unsafe and must not enter the MRI field.
Shipping
Refer to H110 Technical Specifications for shipping conditions.
Storage
Store this product in a cool, dry location, away from direct sunlight. Do not remove the
product from the packaging until it will be used. Refer to H110 Technical Specifications for
storage condition.

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
COMPONENTS OF THE H110
Depth Limiting
Collar

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
H110 INSERTION PROCEDURE SUMMARY FIGURES

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
H110 INSERTION PROCEDURE INSTRUCTIONS
Procedure Preparation
•The following supplies are required:
−H110 Solo ICP Monitoring device
−A cranial access kit that includes a hand drill
−HICP200 with the correct monitor cable for connection to the patient monitor
•Ensure the HICP200 has been properly prepared for the procedure. (For details see the
Maintenance and Care section for the HICP200.)
•Connect the HICP200 to the patient monitor a minimum 15 minutes before beginning the
procedure to allow the transducer to rise to an equilibrium temperature.
•Open the H110 kit using aseptic technique.
Step 1 –Estimate Skull Thickness and Prepare the Access Site
•Select the catheter insertion site for access to the parenchyma.
•Estimate skull thickness using CT scan(s).
•The operative site should be aseptically cleaned and draped.
NOTE: To minimize risk of surgical site infections, it is recommended to prepare the
surgical area in accordance with evidenced-based guidelines, such as Mangram
et al. Guideline for Prevention of Surgical Site Infection, 1999. Infection Control
and Hospital Epidemiology, 20(4), pp. 257-258 and Nichols RL. Preventing
Surgical Site Infections: A Surgeon’s Perspective. Emerging Infectious
Diseases. 7(2), Mar-Apr 2001.
•Make an incision in the scalp and expose the bone with a self-retaining type retractor, or
similar device.
Step 2 –Prepare the Drill Bit Assembly and Drill
•Adjust the Drill Bit Assembly by loosening the set screw on the Depth Limiting Collar with
the provided hex wrench.
•Position the Depth Limiting Collar, exposing the tip of the drill just enough to completely
drill through the skull’s inner table according to the CT scan estimated skull thickness.
Ensure that the set screw is tight enough to prevent movement of the Depth
Limiting Collar on the Drill Bit. However, do not over-torque the set screw.
•Drill a hole in skull using drill bit provided within the kit.

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
Do not change the angle of the drill while drilling, as this could cause the hole to
become too wide or conical.
Care should be exercised to prevent excessive penetration and/or damage to
the dura, cortex, and cortical vessels.
Step 3 –Irrigate the Twist Drill Hole
•Irrigate the drill hole with sterile saline, ensuring that it is cleared of any debris and/or
bone shards.
Bone shards must be removed prior to catheter insertion. Failure to remove
bone shards may damage the catheter’s pressure-sensing bladder.
Step 4 –Incise the Dura
•Open the dura by making a cruciate incision, using the stab incision knife (provided in
the Hummingbird Solo ICP Monitoring or equivalent). Recommended: use the Dilator
provided within the kit, to ensure the incision is large enough to accommodate the
catheter.
Failure to properly incise the dura could cause the catheter’s pressure-sensing
bladder tear during insertion of the H110 and performance to be compromised.

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P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
Step 5 –Measure Skull Thickness
Refer to the Skull Thickness Caliper Quick Guide section of this IFU to. Measure the skull thickness.
Step 6 - Fixation of Bolt
•Position the Bolt in the drill hole.
•To advance the Bolt, screw the Bolt clockwise in skull to the depth of the measured skull
thickness.
If the bolt is loose, the insertion procedure must be repeated at a new site.
NOTE: One full turn (360°) of the bolt advances the bolt 1mm into the skull.
Step 7 –Ensure Incision is Large Enough for Catheter
•Advance the dilator through the bolt to ensure the incision is large enoughto
accommodate the catheter.