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Concordia HIC-4000I, Instructions For Use And Cleaning

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Concordia HIC-4000I Instructions For Use And Cleaning Download Page 2

PC-POD-CP-006-v01 

PC-POD-CP-006-v01 

Printed copies are not controlled. 

Page 

2

 of 

35

 

 

 

Table of Contents

 

SUMMARY ------------------------------------------------------------------------------- 1

 

1.  DEFINITION OF TERMS ---------------------------------------------------------- 3

 

2.  RELEVANT DOCUMENTS ------------------------------------------------------- 3

 

3. INTRODUCTION ------------------------------------------------------------------ 3

 

3.1

 

B

ACKGROUND

 --------------------------------------------------------------------------------------------- 3

 

3.2

 

P

URPOSE

 ---------------------------------------------------------------------------------------------------- 4

 

3.3

 

S

COPE

 ------------------------------------------------------------------------------------------------------- 4

 

3.4

 

R

ESPONSIBILITY

 ---------------------------------------------------------------------------------------------  4

 

4.  MAIN COMPONENTS ------------------------------------------------------------ 4

 

5.  ACRONYMS ------------------------------------------------------------------------- 5

 

5.1

 

H

ARDWARE

 -------------------------------------------------------------------------------------------------  5

 

5.2

 

S

OFTWARE

 --------------------------------------------------------------------------------------------------  6

 

6. HARDWARE AND SOFTWARE SETUP --------------------------------------- 6

 

7.  TEST SETUP ------------------------------------------------------------------------- 8

 

7.1

 

ECG

 

S

ETUP

 ------------------------------------------------------------------------------------------- 8

 

7.2

 

S

UN

T

ECH

 

T

ANGO

+

 

B

LOOD 

P

RESSURE 

S

ETUP

 ------------------------------------------------- 12

 

7.3

 

S

OFTWARE 

S

ETUP

 ----------------------------------------------------------------------------------- 14

 

8.

 

CALIBRATION ------------------------------------------------------------------ 15

 

9.

 

DATA ACQUISITION --------------------------------------------------------- 18

 

9.1

 

O

PENING 

A

CQUISITION 

W

INDOW

 --------------------------------------------------------------- 18

 

9.2

 

OPTION

 

1

 

–

 

C

OLLECT DATA INTERMITTENTLY USING INTER

-

SAMPLE PAUSES

 ------------- 18

 

9.3

 

OPTION

 

2

 

–

 

C

OLLECT DATA CONTINUOUSLY

 ------------------------------------------------ 24

 

9.4

 

OPTION

 

3

 

–

 

C

OLLECT A SINGLE SAMPLE AT A TIME

 ------------------------------------------- 29

 

9.5

 

D

ATA 

A

CQUISITION 

W

INDOW

 ------------------------------------------------------------------- 33

 

9.6

 

D

ATA 

A

CQUISITION 

W

INDOW WITH 

RRI

 

D

ATA

 ---------------------------------------------- 34

 

10.

 

REPORTING --------------------------------------------------------------------- 35

 

11.

 

CLEANING/DISINFECTING --------------------------------------------------  35

 

APPENDIX I: POD TRAINING RECORD FORM

 

 

 

Summary of Contents for HIC-4000I

Page 1: ...pedance Cardiograph PC POD CP 006 v01 Revision History Version Reason for Revision Date 01 New POD August 19 2015 Summary The content of this PERFORM Operating Document POD provides guidelines for the...

Page 2: ...RE AND SOFTWARE SETUP 6 7 TEST SETUP 8 7 1 ECG SETUP 8 7 2 SUNTECH TANGO BLOOD PRESSURE SETUP 12 7 3 SOFTWARE SETUP 14 8 CALIBRATION 15 9 DATA ACQUISITION 18 9 1 OPENING ACQUISITION WINDOW 18 9 2 OPTI...

Page 3: ...olicies SOPs and PODs PC POD GA 001 PERFORM Centre Booking System for Facilities and Equipment PC SOP GA 002 Handling of Biological Materials at PERFORM PC SOP GA 007 General Access to PERFORM Centre...

Page 4: ...This POD applies to all users and supervisors using the HIC 4000I Impedance Cardiograph at the PERFORM Centre Concordia University Any other document other than this POD is out of scope for this oper...

Page 5: ...e CAL Calibrate dZ Change in Basal Thoracic Impedance PWR Power on when light on RESP GAIN Adjust level of Respiration Signal between 0 and max RESP IN Inlet for Respiration Transducer HS GAIN Adjust...

Page 6: ...dt peak Avg Zo 1000 Value 1000sec TFC Total Fluid Content 1000 Avg Zo Value K Ohm Zo Basal Thoracic Impedance This is the base impedance of the thorax displayed in Ohms in the software 6 Hardware and...

Page 7: ...electrodes to measure impendence connect the 3 electrode ECG cable to the electrode input connector labeled ECG IN 6 5 Connect appropriately sized blood pressure cuff to the end of the grey cable mak...

Page 8: ...quired by placing it around the upper limit of the participant s neck leaving an extra 3 4 inches at each end of the electrode tape and cut accordingly 7 1 1 2 Place the tape on a flat surface with th...

Page 9: ...m from the lower edge of the conductive part of electrode band 1 metallic colored band and mark the location 7 1 1 7 Using the electrode tape measure the quantity required by placing the upper edge of...

Page 10: ...electrode band is not in contact with the participant s bra 7 1 1 14 Measure at least 3cm from lower edge of the conductive part of electrode band 3 metallic band and mark the location 7 1 1 15 Place...

Page 11: ...pe lightly scratch an X pattern into the skin taking care to avoid excess abrading 7 1 2 4 Dry the skin vigorously with a gauze pad 7 1 2 5 Place electrodes on the skin 7 1 2 6 Press the contour of el...

Page 12: ...sembly to the electrodes at the appropriate locations 7 2 SunTech Tango Blood Pressure Setup 7 2 1 Explain measurement procedure to participant Instruct participant to relax arm and to not talk during...

Page 13: ...eeve and cuff sleeve up the participant s left arm ensuring the ARTERY marker points down the arm and is over the participants brachial artery As well ensure the lower border of the cuff is placed 3 5...

Page 14: ...NOTE It is recommended that a project folder be created for each participant 7 3 1 5 Select Yes in the Patient Folder Creation Option window 7 3 1 6 Enter subject s general information in the top half...

Page 15: ...indow update information if necessary 7 3 2 9 In the bottom half of the window more specifically in the Posture box select 1 and assign a posture label e g seated standing or reclining In the red boxe...

Page 16: ...ed Page 16 of 35 8 6 On the ICG machine press the CAL key on the keypad 8 7 Wait two or three cycles of the dZ Dt calibration signal a square wave to appear then click the CALIBRATE button 8 8 Click O...

Page 17: ...es are not controlled Page 17 of 35 8 9 If calibration is successful window will show statement COP WIN Calibration Complete as shown below If calibration is unsuccessful click REDO 8 10 Click OK 8 11...

Page 18: ...then Data Acquisition and Setup This window will allow for operational parameters to be specified 9 1 2 Under Acquisition Mode select the desired mode of data acquisition Options are the following 9...

Page 19: ...s shown 9 2 3 Click the Apply button that appears 9 2 4 If you like to manually start and stop data acquisition under the Total Run Time For Continuous Non Stop EA Acquisition Mode select No limit 9 2...

Page 20: ...selection of a specific ID Code NOTE If there are any parameters left to change in the prior screen do so prior to clicking OK as data acquisition will begin as soon as OK is selected 9 2 5 2 Under th...

Page 21: ...t Continuous RRI Mode to enable RRI data acquisition during pre selected time intervals OR select With Each EA Sample using HRV frequency Note that the latter option can only be selected if the inter...

Page 22: ...ct Cancel to make no change to the current settings Select No and another Dialogue Box will appear 9 2 11 Enter a time limit in minutes in the blank area 9 2 12 Select OK 9 2 12 1 If With Each EA Samp...

Page 23: ...anual Mode in order to collect COP HRV data and BP data that is independent of each other NOTE If Manual Mode is selected make sure to program the SunTech Tango To do so press on the main menu button...

Page 24: ...options selected These will be retained through all subsequent executions of the software until changed by the user 9 2 21 The Data Acquisition Window will appear 9 3 OPTION 2 Collect data continuous...

Page 25: ...its the user to acquire and label data samples with an ID Code To turn this option on select Limit to then check BLOCK MODE under Block Run Time For Continuous Non Stop EA Acquisition Mode When this o...

Page 26: ...I data acquisition OR select Continuous RRI Mode to enable RRI data acquisition during pre selected time intervals OR select With Each EA Sample using HRV frequency Note that the latter option can onl...

Page 27: ...to make no change to the current settings Select No and another Dialogue Box will appear 9 3 10 Enter a time limit in minutes in the blank area 9 3 11 Select OK 9 3 11 1 If With Each EA Sample using...

Page 28: ...terval times and or clicking the READ BP control button 9 3 15 Select Manual Mode in order to collect COP HRV data and BP data that is independent of each other NOTE If Manual Mode is selected make su...

Page 29: ...ged by the user 9 3 20 The Data Acquisition Window will appear 9 4 OPTION 3 Collect a single sample at a time 9 4 1 For acquisition of impedance data upon user command according to specifications on t...

Page 30: ...rs acquisition will be continuous from the time the user starts data acquisition until the user stops the acquisition 9 4 6 In order to set a time limit click the No Limit button and a Dialogue Box wi...

Page 31: ...e RRI sample by using the spin control The options for the number of seconds for these samples are limited to resultants obtained from raising 2 to the power of 7 8 9 or 10 NOTE The minimum time is 12...

Page 32: ...NOTE In this mode BP will only be collected when the READ button is clicked in the Acquisition Window or when another reading is initiated by the monitor s internal timer 9 4 14 Under BP Value Valid F...

Page 33: ...tinuous mode if continuous data is required until the pre set time limit is reached 9 5 5 Select Auto Save if you want data collected to be saved automatically 9 5 6 Under the Posture frame ensure tha...

Page 34: ...n mode is Continuous with No Time Limit 9 6 2 1 1 To start RRI data acquisition click Start RRI Acquisition 9 6 2 1 2 To stop RRI data acquisition click Stop RRI Acquisition 9 6 2 2 If the RRI acquisi...

Page 35: ...red from drop down menu 10 2 Should Select Parameters for Printing be selected a wide range of parameters could be selected for printing 11 Cleaning Disinfecting 11 1 Clean blood pressure cuff accordi...

Page 36: ...PC POD CP 006 v01 PC POD CP 006 v01 Printed copies are not controlled APPENDIX I APPENDIX I PODTraining Record Form...

Page 37: ...itle Use and Cleaning of HIC4000I Impedance Cardiograph SOP Code Ownership Document type Area SOP Number Version PC POD CP 006 V01 Training Record Full Name Institution Contact email or phone number S...

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