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Summary of Contents for Humminbird HICP200
- Page 1 Instructions for Use Hummingbird ICP Control Module Picture for Reference Only HICP200 P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved Page 1 of 38...
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Page 2: Table Of Contents
COMPONENTS OF THE HUMMINGBIRD ICP CONTROL MODULE ........6 ..........................7 RONT ....................... 8 HUMMINGBIRD ICP CONTROL MODULE: SETTING UP THE SYSTEM FOR THE FIRST TIME ............................8 1: U (REF: HICP200) ................ 8 NPACK THE YSTEM 2: A AC P .................. 9 TTACH THE... - Page 3 TECHNICAL SPECIFICATIONS .....................27 ..................27 IST OF ECHNICAL PECIFICATIONS OPERATION MODES ......................29 CLASSIFICATION AND STANDARDS ..................29 MANUFACTURER’S DECLARATION TABLE ..............29 ........................29 ENERAL OTES WARNINGS ........................34 CAUTIONS ..........................36 WARRANTY ..........................37 LIMITATIONS OF LIABILITY ....................37 RETURN GOODS POLICY ....................37 ........................37 UPPLIED ORDERING INFORMATION ....................37 P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28;...
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Page 4: List Of Symbols And Abbreviations
IST OF YMBOLS AND BBREVIATIONS 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. -
Page 5: System Overview
VERVIEW 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... -
Page 6: Indications For Use
The Hummingbird ICP Control Module only supports the following Hummingbird Devices: Table 2: Compatible Hummingbird ICP Control Module Catheters IRRAS Model Parenchymal Bolt Ventricular 2-probe (REF#) Access Drainage 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. -
Page 7: Front View
Front View Zero Patient Monitor Button Zero Patient Monitor Indicator Light Connect Catheter Indicator Light Prime System Indicator Light Hummingbird, Run Mode Indicator Light Prime System Button Battery Status Lights/Error Codes Battery Status Button HUMMINGBIRD ICP CONTROL MODULE Pause Alarm Indicator Light PATIENT CABLE MODULE Pause Alarm Button MONITOR CABLE... -
Page 8: Rear/Side/Top View
ETTING YSTEM FOR THE IRST 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. P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; ©2021, IRRAS USA, Inc., All rights reserved... -
Page 9: Step 2: Attach The Ac Power Supply
ICP Control Module Qty. 1 Patient Cable Module Qty. 1 Monitor Cable Qty. 1 AC Power Supply Qty. 1 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. -
Page 10: Step 3: Use Ac Power To Charge The Battery To Full Capacity
Step 3: Use AC Power to Charge the Battery to Full Capacity 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;... -
Page 11: Setting Up System For Clinical Use
ETTING YSTEM FOR LINICAL The following section contains instructions for positioning the monitor, powering the monitor, and connecting catheters to the monitor. Positioning the Hummingbird ICP Control Module The Hummingbird ICP Control Module is intended to be securely clamped to an equipment pole or bed support next to the patient. -
Page 12: Attaching To Equipment Pole
Attaching to Equipment Pole The Hummingbird ICP Control Module includes a clamp to attach it to an equipment pole. To attach: 1. Position thumbs on the front panel of the ICP Control Module and the fingers on the spring-loaded tabs (Fig. 4) on the back panel of the Hummingbird ICP Control Module. -
Page 13: Hummingbird Icp Control Module Setup
ICP C UMMINGBIRD ONTROL ODULE ETUP The Hummingbird ICP Control Module Monitor Cable is designed to connect directly to the patient monitor with Invasive Blood Pressure (IBP) measurement capability. Turn the patient monitor on. To operate: THINK I.C.P. Step 1: Insert and Zero a. - Page 14 The Patient Cable Module must communicate with atmospheric pressure when zeroing the patient monitor. Failure to remove the catheter and/or HICP200 Plug from the Patient Cable Module prior to re-zeroing may result in inaccuracy. d. Press ‘Zero Monitor’ button on the ICP Control Module.
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Page 15: Step 2: Connect
THINK I.C.P. Step 2: Connect a. Connect the Hummingbird ICP Control Module Catheter connector to the Patient Cable Module. Push firmly, listening for an audible click. Note: Prior to connecting the ICP Catheter to the Patient Cable Module, the Hummingbird ICP Control Module Catheter will have been placed. -
Page 16: Step 3: Prime
THINK I.C.P. Step 3: Prime a. Press the “Prime System” button on the ICP Control Module to prime the catheter. Note: Indicator: Pressing the Prime System button will automatically prime the ICP system with the requisite volume of air to measure ICP. -
Page 17: Run Mode
2. Disconnect the ICP Catheter Connector from the Patient Cable Module. 3. Place the ICP Connector Cap onto ICP Catheter Connector 4. Insert the HICP200 Plug into the Patient Cable Module 5. Place the Patient Cable Module into cable hook at base of ICP Control Module. -
Page 18: Switching/Setting Up A New Patient Monitor
Note: The Hummingbird ICP Control Module can remain on the equipment pole or be placed on the bed for transport. Switching/Setting up a new patient monitor Repeat the Hummingbird ICP Control Module Setup procedure, including the I.C.P. sequence, whenever changing the patient monitor. Shutdown / Storage of the Hummingbird ICP Control Module Disconnect ICP Connector Press Stop... -
Page 19: Storing The Hummingbird Icp Control Module
Routinely check the performance of the battery prior to and during use. When the AC Power Supply is plugged into the outlet, the Battery Status Lights will be on and green. Each light that is on indicates 20% of battery life. When the unit is operating under battery power, the battery status lights will remain off until the Battery Status button is pressed or the battery is less than 40% charged. -
Page 20: About The Alarms
Velcro strap. Place the AC Power Supply into the frame. BOUT THE LARMS Physiological alarms are provided by the connected patient monitor and not the HICP200. Technical alarms are alarms originating in the device due to faults, or scenarios that require user intervention. -
Page 21: Silencing Audio Alarms Temporarily
Low Priority Fault Stuck Button Use Fault Low Battery Voltage Fault Failure to Vent Fault Failure to Evacuate Fault System Leak Fault Patient Monitor Pulsed / AC Excitation Fault Patient Monitor Excitation Range Fault Alarm Battery Charge Level Battery LED Alarm Speaker Output /Priority Indicator... -
Page 22: Cleaning Patient Cable Module
3. Insert the swab inside the Patient Cable Module connector. 4. Rotate the swab inside the connector. 5. Insert an HICP200 Plug into the Patient Cable Module Note About Hummingbird Neuromonitoring Catheters Hummingbird Neuromonitoring catheters are intended for single use only and cannot be resterilized. -
Page 23: Trouble Shooting The System
Zero Wait Mode and clear an error code. The patient monitor can be zeroed at any time by pressing the “STOP” button, disconnecting the catheter or HICP200 Plug (whichever is attached) from the Patient Cable Module and performing the standard protocol for zeroing the patient monitor. - Page 24 Fault LED Condition / Prompt Priming Fault – gross system leak / catheter not connected to HICP200: Check to make sure the catheter is connected. Visually check the catheter to make sure the catheter is connected to patient cable module.
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Page 25: Contacting Irras Usa, Inc. For Technical Support
Fault LED Condition / Prompt Priming Fault – pneumatic source or cable kinked Clear fault and re-prime the system. If fault does not clear, replace Hummingbird ICP Control Module. Incompatible patient monitor: Change patient monitors. Incompatible patient monitor: Change patient monitors. Stuck Button Press each button and attempt to release button. -
Page 26: Prior To Each Use
There are no serviceable parts within the Hummingbird ICP Control Module Device. Warning To reduce the risk of electric shock, do not disassemble the Hummingbird ICP Control Module. Refer all servicing to qualified service personnel at IRRAS USA, Inc. No modification of the Hummingbird ICP Control Module is allowed. -
Page 27: Replacement Parts
▪ Check leakage currents ▪ Check accuracy ▪ Set-up the Hummingbird ICP Control Module with a bedside monitor ▪ Apply a test pressure ▪ Confirm that the Hummingbird ICP Control Module provides the accuracy stated in the SPECIFICATIONS section of these instructions for use ▪... - Page 28 Item Specification ➢ Temperature = 15 °C to 39 °C Operation Limits ➢ Humidity = 15% to 95% relative humidity, non-condensing ➢ Temperature = 5 °C to 40 °C Shipping/Storage ➢ Humidity = Relative humidity ranging from 5% to 95% non- Limits condensing Rated ICP Accuracy...
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Page 29: Operation Modes
PERATION ODES Item Specification Standby Mode Initializes System Zero Wait Mode Entered by connecting Monitor Cable to patient monitor; prompts user to zero patient monitor Prime Wait System is ready to be primed Priming Mode System is being automatically primed Run Mode Allows measurement of ICP to display on patient monitor Fault Mode... - Page 30 During immunity testing, the Hummingbird ICP Control Module maintained its ability to monitor pressure within specification or issued an alarm to advise the user that the data was not reliable. Faults could be corrected by cycling the power. Warning Use of accessories and cables other than those specified by IRRAS USA, Inc. may result in increased emissions or decreased immunity of the Hummingbird ICP Control Module.
- Page 31 Guidance and manufacturer’s declaration – electromagnetic immunity Hummingbird ICP Control Module is intended for use in the electromagnetic environment Hummingbird ICP Control Module specified below. The customer or the user of the should assure that it is used in such an environment. IEC 60601 test Electromagnetic environment Immunity test...
- Page 32 Guidance and manufacturer’s declaration – electromagnetic immunity Hummingbird ICP Control Module is intended for use in the electromagnetic environment Hummingbird ICP Control Module specified below. The customer or the user of the should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic environment –...
- Page 33 Recommended separation distances between portable and mobile RF communications equipment and the Hummingbird ICP Control Module The Hummingbird ICP Control Module is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment.
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Page 34: Warnings
Monitor Cable is contraindicated for use in a Magnetic Resonance (MR) environment. During setup, remove the catheter or HICP200 Plug (whichever is attached) on the Hummingbird ICP Control Module Patient Cable Module prior to zeroing the patient monitor. Failure to remove the catheter and/or HICP200 Plug from the Patient Cable Module prior to re-zeroing may result in inaccuracy. - Page 35 To reduce the risk of electric shock, do not disassemble the Hummingbird ICP Control Module. Refer all servicing to qualified service personnel at IRRAS USA, Inc. To prevent damage to the precision equipment or personnel, only use the AC Power Supply provided by IRRAS USA, Inc. The AC Power Supply is identified and labeled to ensure proper identification.
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Page 36: Cautions
The Hummingbird ICP Control Module contains a Lithium Ion Battery. This battery is internal and is not user replaceable. If the battery needs replacement, refer servicing to qualified service personnel at IRRAS USA, Inc.” Repeat the Hummingbird ICP Control Module Setup procedure, including the I.C.P. sequence, whenever changing the patient monitor. -
Page 37: Warranty
WARRANTY All devices bearing the IRRAS USA, Inc. brand are guaranteed to be free of functional defects in workmanship and materials when used normally for their intended surgical use. Any IRRAS USA, Inc. device proving to be defective will be replaced. - Page 38 Manufacturer IRRAS USA, Inc. 11975 El Camino Real Suite 304 San Diego, CA 92130 TEL: 1(800) 213-4604 orders@hummingbirdneuromonitoring.com CAUTION: Federal law restricts this device to sale by or on the order of a physician (licensed healthcare practitioner). Do not use if the package has been opened or damaged.
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