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P/N: 7000717 Rev A, CO-148, Released Date: 2021-01-28; 

©2021, IRRAS USA, Inc., All rights reserved   

 

 

 Page 

2

 of 

38 

Table of Contents 

LIST OF SYMBOLS AND ABBREVIATIONS ......................................................................... 4

 

SYSTEM OVERVIEW ............................................................................................................... 5

 

D

ESCRIPTION

 ........................................................................................................................... 5

 

Indications For Use .............................................................................................................. 6

 

Contraindications ................................................................................................................. 6

 

I

NTENDED 

U

SER

 ....................................................................................................................... 6

 

COMPONENTS OF THE HUMMINGBIRD ICP CONTROL MODULE ................................... 6

 

F

RONT 

V

IEW

 ............................................................................................................................ 7

 

R

EAR

/S

IDE

/T

OP 

V

IEW

 ............................................................................................................... 8

 

HUMMINGBIRD ICP CONTROL MODULE: SETTING UP THE SYSTEM FOR THE FIRST 
TIME .......................................................................................................................................... 8

 

S

TEP 

1:

 

U

NPACK THE 

S

YSTEM 

(REF:

 

HICP200) ........................................................................ 8

 

S

TEP 

2:

 

A

TTACH THE 

AC

 

P

OWER 

S

UPPLY

 .................................................................................. 9

 

S

TEP 

3:

 

U

SE 

AC

 

P

OWER TO 

C

HARGE THE 

B

ATTERY TO 

F

ULL 

C

APACITY

 .....................................10

 

S

TEP 

4:

 

C

ONNECT THE 

M

ONITOR 

C

ABLE TO THE 

H

UMMINGBIRD 

ICP

 

C

ONTROL 

M

ODULE

 .............10

 

SETTING UP SYSTEM FOR CLINICAL USE ........................................................................11

 

P

OSITIONING THE 

H

UMMINGBIRD 

ICP

 

C

ONTROL 

M

ODULE

 ..........................................................11

 

A

TTACHING TO 

E

QUIPMENT 

P

OLE

 .............................................................................................12

 

HUMMINGBIRD ICP CONTROL MODULE SETUP ..............................................................13

 

S

TEP 

1:

 

I

NSERT AND 

Z

ERO

 .......................................................................................................13

 

S

TEP 

2:

 

C

ONNECT

 ...................................................................................................................15

 

S

TEP 

3:

 

P

RIME

 ........................................................................................................................16

 

R

UN 

M

ODE

 ..............................................................................................................................17

 

P

ATIENT 

T

RANSPORTATION

 ......................................................................................................17

 

S

WITCHING

/S

ETTING UP A NEW PATIENT MONITOR

 .....................................................................18

 

S

HUTDOWN 

/

 

S

TORAGE OF THE 

H

UMMINGBIRD 

ICP

 

C

ONTROL 

M

ODULE

 ......................................18

 

BATTERY MANAGEMENT .....................................................................................................18

 

STORING THE HUMMINGBIRD ICP CONTROL MODULE ..................................................19

 

ABOUT THE ALARMS............................................................................................................20

 

S

ILENCING 

A

UDIO 

A

LARMS 

T

EMPORARILY

 .................................................................................21

 

CLEANING THE SYSTEM ......................................................................................................21

 

C

LEANING THE 

S

YSTEM AND 

C

OMPONENTS

...............................................................................21

 

C

LEANING 

G

UIDELINES

 ............................................................................................................21

 

C

LEANING 

P

ATIENT 

C

ABLE 

M

ODULE

 .........................................................................................22

 

N

OTE 

A

BOUT 

H

UMMINGBIRD 

N

EUROMONITORING 

C

ATHETERS

 ...................................................22

 

TROUBLE SHOOTING THE SYSTEM ...................................................................................23

 

T

ROUBLE 

S

HOOTING 

E

RROR 

C

ODES

 ........................................................................................23

 

CONTACTING IRRAS USA, INC. FOR TECHNICAL SUPPORT .........................................25

 

A

BOUT 

T

ECHNICAL 

S

UPPORT

 ...................................................................................................25

 

P

RIOR TO EACH USE

: ...............................................................................................................26

 

D

URING 

O

PERATION

: ...............................................................................................................26

 

A

NNUALLY OR AFTER 

6

 MONTHS OR LONGER IN STORAGE

: .........................................................26

 

R

EPLACEMENT 

P

ARTS

 .............................................................................................................27

 

Содержание HICP200

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

Страница 2: ...ING 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 TRANSPO...

Страница 3: ...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 WARR...

Страница 4: ...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 Mo...

Страница 5: ...back 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...

Страница 6: ...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...

Страница 7: ...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...

Страница 8: ...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 I...

Страница 9: ...ing 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...

Страница 10: ...ress 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 Su...

Страница 11: ...ntrol Module The Hummingbird ICP Control Module is intended to be securely clamped to an equipment pole or bed support next to the patient The distance between the patient and the Hummingbird ICP Cont...

Страница 12: ...4 on the back panel of the Hummingbird ICP Control Module Squeeze the tabs to open the equipment pole securement feature 2 Gradually release the squeeze tabs on the pole clamp Fig 5 to secure the Hum...

Страница 13: ...to the patient monitor s IBP receptacle will power up the Hummingbird ICP Control Module b Check functionality of the LEDs the audible chimes and the audible beeps During power up of the Hummingbird...

Страница 14: ...Module or the patient monitor check all connections If you still do not see the expected results do NOT use the Hummingbird ICP Control Module Contact IRRAS USA Inc for assistance c Zero patient moni...

Страница 15: ...aced Please refer to the appropriate Hummingbird H110 and H610 IFU for the catheter placement procedure Note Indicator The arrow marking on the ICP Catheter Connector should align with the flat keyway...

Страница 16: ...This provides real time verification of proper sequencing During the priming sequence the ICP waveform on the patient monitor will be a flat line reading approximately 0 mmHg Do not zero the patient...

Страница 17: ...will automatically perform a priming sequence three times within the first two hours at 5 minutes at 30 minutes and at 90 minutes and 60 minutes thereafter This is designed to check the integrity of...

Страница 18: ...onnecting the Monitor Cable will place the Hummingbird ICP Control Module in standby state Ensure that the ICP Control Module is plugged into an AC outlet when stored Store the cables with the Humming...

Страница 19: ...Green 20 to 40 Green Less than 20 The Hummingbird ICP Control Module displays the following symbols on the status bar to indicate battery charge levels when not plugged into AC power outlet Symbol Co...

Страница 20: ...200 Technical alarms are alarms originating in the device due to faults or scenarios that require user intervention The Hummingbird ICP Control Module activates one technical alarm for exceeding the o...

Страница 21: ...dule is designed for surface cleaning only do NOT immerse Never spray cleaning agents or other fluids directly onto the ICP Control Module Use particular care when cleaning around the connectors Be su...

Страница 22: ...pe soaked with 70 IPA and continue wiping the surfaces until they are visibly free of residues Recommended Disinfection Agents Hummingbird ICP Control Module has been tested and shown to withstand exp...

Страница 23: ...Module has no light indication ensure the Monitor Cable is properly connected to the patient monitor and the monitor is turned on If the Hummingbird ICP Control Module is plugged into the patient moni...

Страница 24: ...ound Clear fault and re prime the system Monitor the condition Priming Fault restricted flow flow rate too low Check the Cable to ensure that it is not kinked Clear fault and re prime the system Monit...

Страница 25: ...em leak or pneumatic line kink disconnect the ICP Catheter Connector from the Patient Cable Module and follow THINK I C P Zero patient monitor Press Zero Patient Monitor button on ICP Control Module C...

Страница 26: ...system pressure sensor and must be handled with care Do not kink puncture or drop the Hummingbird ICP Control Module Patient Cable A Hummingbird ICP Control Module patient cable that is kinked or dam...

Страница 27: ...number Hummingbird ICP Control Module AC Power Supply contact IRRAS USA Inc for specific model number To maintain the safe and accurate operation of the Hummingbird ICP Control Module use only IRRAS...

Страница 28: ...nt drift does not exceed 15 mmHg per 24 hour period Re zeroing the transducer can be performed in situ and is recommended if the user operates the system outside of the manufacturer s recommendations...

Страница 29: ...his section such as separation distances is in general specifically written with regards to the IRRAS USA Inc Hummingbird ICP Control Module General Notes In the event this device interferes with othe...

Страница 30: ...east 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that...

Страница 31: ...Hz Level 0 Duration cycles 25 50 Hz Level 70 Duration cycles 30 60 Hz Level 70 Duration cycles 250 50 Hz Level 0 Duration cycles 300 60 Hz Level 70 Device shall meet manufacturer s performance criteri...

Страница 32: ...distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may oc...

Страница 33: ...ers and the Hummingbird ICP Control Module as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance acco...

Страница 34: ...RH or greater change Failure to re prime may result in pressure readings higher or lower than the stated accuracy claims such as in the case of transport from one location to another The Hummingbird I...

Страница 35: ...ated To ensure safe operation 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 On...

Страница 36: ...or similar environment It may be used during intra hospital transport The IV Pole securement feature has been designed to secure the Hummingbird ICP Control Module to IV pole diameters in the range o...

Страница 37: ...ectly affect this device and the results obtained from its use IRRAS USA Inc will not be liable for INCIDENTAL or CONSEQUENTIAL LOSS DAMAGE or EXPENSE directly or indirectly arising from the use of th...

Страница 38: ...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 opene...

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