Humminbird HICP200 User manual

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 1of 38
Instructions for Use
Hummingbird ICP Control Module
HICP200
Picture for Reference Only

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 2of 38
Table of Contents
LIST OF SYMBOLS AND ABBREVIATIONS ......................................................................... 4
SYSTEM OVERVIEW............................................................................................................... 5
DESCRIPTION........................................................................................................................... 5
Indications For Use.............................................................................................................. 6
Contraindications................................................................................................................. 6
INTENDED USER....................................................................................................................... 6
COMPONENTS OF THE HUMMINGBIRD ICP CONTROL MODULE ................................... 6
FRONT VIEW ............................................................................................................................ 7
REAR/SIDE/TOP VIEW............................................................................................................... 8
HUMMINGBIRD ICP CONTROL MODULE: SETTING UP THE SYSTEM FOR THE FIRST
TIME.......................................................................................................................................... 8
STEP 1: UNPACK THE SYSTEM (REF: HICP200)........................................................................ 8
STEP 2: ATTACH THE AC POWER SUPPLY.................................................................................. 9
STEP 3: USE AC POWER TO CHARGE THE BATTERY TO FULL CAPACITY .....................................10
STEP 4: CONNECT THE MONITOR CABLE TO THE HUMMINGBIRD ICP CONTROL MODULE .............10
SETTING UP SYSTEM FOR CLINICAL USE ........................................................................11
POSITIONING THE HUMMINGBIRD ICP CONTROL MODULE ..........................................................11
ATTACHING TO EQUIPMENT POLE.............................................................................................12
HUMMINGBIRD ICP CONTROL MODULE SETUP ..............................................................13
STEP 1: INSERT AND ZERO.......................................................................................................13
STEP 2: CONNECT...................................................................................................................15
STEP 3: PRIME ........................................................................................................................16
RUN MODE..............................................................................................................................17
PATIENT TRANSPORTATION......................................................................................................17
SWITCHING/SETTING UP A NEW PATIENT MONITOR.....................................................................18
SHUTDOWN /STORAGE OF THE HUMMINGBIRD ICP CONTROL MODULE ......................................18
BATTERY MANAGEMENT.....................................................................................................18
STORING THE HUMMINGBIRD ICP CONTROL MODULE..................................................19
ABOUT THE ALARMS............................................................................................................20
SILENCING AUDIO ALARMS TEMPORARILY.................................................................................21
CLEANING THE SYSTEM......................................................................................................21
CLEANING THE SYSTEM AND COMPONENTS...............................................................................21
CLEANING GUIDELINES ............................................................................................................21
CLEANING PATIENT CABLE MODULE .........................................................................................22
NOTE ABOUT HUMMINGBIRD NEUROMONITORING CATHETERS ...................................................22
TROUBLE SHOOTING THE SYSTEM...................................................................................23
TROUBLE SHOOTING ERROR CODES ........................................................................................23
CONTACTING IRRAS USA, INC. FOR TECHNICAL SUPPORT .........................................25
ABOUT TECHNICAL SUPPORT ...................................................................................................25
PRIOR TO EACH USE: ...............................................................................................................26
DURING OPERATION:...............................................................................................................26
ANNUALLY OR AFTER 6MONTHS OR LONGER IN STORAGE: .........................................................26
REPLACEMENT PARTS .............................................................................................................27

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 3of 38
TECHNICAL SPECIFICATIONS.............................................................................................27
LIST OF TECHNICAL SPECIFICATIONS ........................................................................................27
OPERATION MODES .............................................................................................................29
CLASSIFICATION AND STANDARDS..................................................................................29
MANUFACTURER’S DECLARATION TABLE ......................................................................29
GENERAL NOTES.....................................................................................................................29
WARNINGS.....................................................................................................................34
CAUTIONS ..............................................................................................................................36
WARRANTY.............................................................................................................................37
LIMITATIONS OF LIABILITY ...................................................................................................37
RETURN GOODS POLICY ...............................................................................................37
HOW SUPPLIED .......................................................................................................................37
ORDERING INFORMATION...................................................................................................37

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 4of 38
LIST OF SYMBOLS AND ABBREVIATIONS
Symbol
Meaning
Manufacturer
Date of manufacture expressed as year-month-day (yyyy-mm-dd).
Refer to the Instructions for Use
In the United States of America, federal law restricts this device to sale by or
on the order of a physician, physical therapist, occupational therapist, or
equivalent healthcare professional.
Monitor Interconnect Cable Port
Contents
Model number
Serial number
Type BF applied part (per IEC 60601-1)
Temperature limits
Relative humidity limits
Keep dry
Class II equipment per IEC 60601-1
Only use the Hummingbird ICP Control Module AC Power Supply with the
Hummingbird ICP Control Module device:
MR Unsafe
General Warning
CONT

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 5of 38
SYSTEM OVERVIEW
Description
The Hummingbird ICP Control Module (REF: HICP200) is a ICP Control Module with an
integrated Patient Cable Module and a Monitor Cable specific to the hospital’s monitor. The
Hummingbird ICP Control Module, when used with a Hummingbird H110 and H610 devices
and a cable compatible with the hospital’s monitor, comprises a system whose principle of
operation is based on air-coupled pressure transduction.
The Hummingbird Patient Cable Module houses the pressure transducer and provides a
high-reliability pneumatic connection to the Hummingbird H110 and H610 devices. The
connector provides for audible and tactile feedback indicating a secure connection. The
intracranial pressure (ICP)waveform is transduced in the Patient Cable Module and the
analog signal is transmitted to the patient monitor, according to AAMI BP-22 standard
protocol of 5µV/V/mmHg.
The Hummingbird ICP Control Module monitors the same ICP signal transmitted to the
hospital monitor to control and implement system air priming cycle requirements and user
interface audio/visual system status.
The Hummingbird ICP Control Module is reusable so long as the instructions contained
herein are followed, while the Hummingbird H110 and H610 devices are single-use devices
only. The Hummingbird ICPControl Module is compatible with the following patient monitors.
Table 1: Compatible Patient Monitors and
Corresponding Monitor-Specific Cable Model Number
Patient monitor
Monitor Cable Model
Number
Image
Spacelabs Scout 6-
Pin
7000332
HP / Philips 12-Pin
Veridia
7000334
GE / Marquette Tram
11-Pin
7000335

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 6of 38
The Hummingbird ICP Control Module only supports the following Hummingbird Devices:
Table 2:Compatible Hummingbird ICP Control Module Catheters
IRRAS Model
(REF#)
Parenchymal
ICP
Bolt
Access
Ventricular
Drainage
2-probe
ports
H110


H610




Note
Hummingbird Catheter Model #s H110 and H610 are MR Conditional at 1.5/3.0T.
The Hummingbird ICP Control Module with an integrated Patient Cable
Module and a Monitor Cable is contraindicated for use in a Magnetic
Resonance (MR) environment.
All Hummingbird devices measure ICP with a sensor that sits in the parenchyma. This design
eliminates the need for a fluid-filled system to communicate pressure (and carry waves) to
an external transducer.
Indications For Use
The Hummingbird ICP Control Module is designed for use with the Hummingbird H110 and
H610 devices. Together, they comprise a system that is indicated for use in those conditions
where continuous monitoring of ICP is required. As dictated by clinical judgment, direct
measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular
locations.
Contraindications
The Hummingbird ICP Control Module with an integrated Patient Cable
Module and a Monitor Cable is contraindicated for use in a Magnetic
Resonance (MR) environment.
Intended User
The Hummingbird ICP Control Module is intended to be used by the following qualified medical
and biomedical professionals:
•A qualified healthcare professional 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 operate the Hummingbird ICP Control
Module.
COMPONENTS OF THE HUMMINGBIRD ICP CONTROL MODULE
The following section provides information on the different components of the Hummingbird ICP
Control Module

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 7of 38
Front View
Figure 1 –Hummingbird ICP Control Module,
Patient Cable Module, and Monitor Cable
Figure 2 –Expanded view of Front Panel showing Indicator Lights and
Control Buttons
A
C
F
J
L
K
H
Zero Patient Monitor Button
A
B
C
D
E
F
G
Connect Catheter Indicator Light
Prime System Button
Battery Status Lights/Error Codes
Pause Alarm Indicator Light
Pause Alarm Button
Zero Patient Monitor Indicator Light
DB
HBattery Status Button
I
Hummingbird, Run Mode Indicator Light
G
J
Prime System Indicator Light
E
Stop Button
K
I
Alarm Indicator Light
L
IV
II
III
MONITOR CABLE
PATIENT CABLE MODULE
AC POWER SUPPLY CABLE
I
III
II
IV
I
HUMMINGBIRD ICP CONTROL MODULE

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 8of 38
Rear/Side/Top View
Rear View
Side View
Top View
HUMMINGBIRD ICP CONTROL MODULE: SETTING UP THE SYSTEM FOR THE
FIRST TIME
Step 1: Unpack the System (REF: HICP200)
Remove the contents from the Hummingbird ICP Control Module shipping box and
verify the following items are included.
Pole Clamp
AC Port AC Port

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 9of 38
After unpacking the contents, inspect the shipment for any signs of damage or loss. If
any damages are discovered, notify the carrier, the supplier, and retain all shipping
cartons for examination.
Step 2: Attach the AC Power Supply
a. Remove the AC Power Supply from the package and connect the AC Power Supply
to the Hummingbird ICP Control Module.
i. Insert the plug end of the AC Power Supply into a grounded AC wall outlet.
ii. On the back of the Hummingbird ICP Control Module, attach the connector
end of the AC Power Supply into the AC Port.
ICP Control Module
Qty. 1
Patient Cable Module
Qty. 1
Monitor Cable
Qty. 1
AC Power Supply
Qty. 1

P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved
Page 10 of 38
Step 3: Use AC Power to Charge the Battery to Full Capacity
a. Keep the Hummingbird ICP Control Module on AC power for at least 10 hours.
This will charge the battery to full capacity.
b. After 10 hours, depress battery status button on the main display to verify the display
shows five green bars; this indicates the battery has full charge.
c. Use only the provided Hummingbird ICP Control Module AC Power Supply with the
Hummingbird ICP Control Module. Plug the other end of the power cord into a
hospital, 100-240 V, 50/60 Hz, wall outlet.
Step 4: Connect the Monitor Cable to the Hummingbird ICP Control Module
a. Confirm the Monitor Cable has clicked into the Hummingbird ICP Control Module
cable port and is secure.