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P/N 490206 Rev E

2008T Hemodialysis Machine with CLiC Device User’s Guide

2008T Hemodialysis Machine
with CLiC Device Overview

CLiC

Verification

Filter

USB

Connector

Red

Light

Optical
Sensor

Disposable

Crit-Line

Blood

Chamber

Crit-Line in a Clip

(CLiC)

2008T Hemodialysis Machine

“Crit-Line” screen

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Summary of Contents for 2008T

Page 1: ...2008T Hemodialysis Machine with CLiC Device User s Guide ...

Page 2: ......

Page 3: ...parameters of treatment are to be determined by the prescribing physician Note Not all features are available in all regions Indications for Use 2008T Hemodialysis Machine The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy Crit Line Clip Monitor CLiC Optional The Crit Line Clip Monitor is used with the 2008T Hemodialysis Machine to non invasively measure hematocrit ...

Page 4: ...d Volume BV Graph 14 The Oxygen O2 Saturation Graph 16 The Hematocrit Graph 18 The Blood Pressure Graph 20 Ending a CLiC Device Monitored Treatment 22 CLiC Device Care 24 Cleaning and Disinfecting the CLiC Device 24 CLiC Device Disposal 24 Troubleshooting 25 Service Mode 30 Enabling the CLiC device in Service Mode 30 Selecting the Crit Line Graph Type 30 Calibrating the CLiC device 30 Appendix 31 ...

Page 5: ...evice is only a tool used to complement a treatment on the 2008T hemodialysis machine Operators must rely on their own clinical assessment of the patient to administer the treatment as per the standard of care Note If the 2008T hemodialysis machine displays the message Crit Line needs verification the CLiC device must be verified for accuracy before using it to monitor the treatment To verify the ...

Page 6: ...ith CLiC Device User s Guide 2008T Hemodialysis Machine with CLiC Device Overview CLiC Verification Filter USB Connector Red Light Optical Sensor Disposable Crit Line Blood Chamber Crit Line in a Clip CLiC 2008T Hemodialysis Machine Crit Line screen ...

Page 7: ...ration and percent change in blood volume during dialysis The CLiC device clips onto the Crit Line Blood Chamber which is positioned between the arterial bloodline and the inlet port of the dialyzer The CLiC device shines a red light through the lens of the Crit Line Blood Chamber and onto a sensor on the opposite side of the blood chamber This sensor detects the level of absorption and scattering...

Page 8: ...6 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide Connecting the Crit Line Blood Chamber 1 2 3 ...

Page 9: ... blood chamber should be kept clean and free of obstruction 2 Connect Crit Line Blood Chamber to dialyzer Remove the blood chamber from its sterile package and aseptically attach it to the arterial port of the dialyzer as shown on the facing page Make sure the connection is tight 3 Continue setting up the bloodlines Continue to set up the bloodlines as described in Chapter 2 Connecting the Extraco...

Page 10: ...8 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide Connecting the CLiC Device to the Blood Chamber 1 2 3 ...

Page 11: ...the right side of the 2008T hemodialysis machine display screen 1 Place the CLiC device over the Crit Line Blood Chamber so that the optical sensor covers the lens of the Crit Line Blood Chamber 2 Release the clip to allow the optical sensor to seat on the viewing area of the Crit Line Blood Chamber 3 Make certain that the CLiC device has locked securely into place on the Crit Line Blood Chamber b...

Page 12: ...10 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide Monitoring the Treatment from the Crit Line Screen The Crit Line screen showing BV and O2 Sat graphs ...

Page 13: ...ialysate Flow The dialysate flow rate selected for the treatment and set on the Home screen ml min The dialysate flow rate can also be turned on or off from the Dialysate screen Temp Temperature The temperature of the dialysate as displayed on the Home screen C Cond Conductivity The conductivity of the dialysate as displayed on the Home screen mS cm Blood Flow Blood Flow Rate The current blood pum...

Page 14: ...E 2008T Hemodialysis Machine with CLiC Device User s Guide Reading Graphs on the Crit Line Screen The Crit Line screen showing BV and O2 Sat graphs with markers The Crit Line screen showing Hct and BP graphs with markers ...

Page 15: ...then the Elapsed Time is paused along with CLiC device data collection Initial Hct The initial hematocrit Hct value is recorded along with the first data point when graphing begins Initial est Hb The estimated initial hemoglobin Hb value is recorded along with the first data point when graphing begins It is calculated based on the hematocrit reading Markers button Selecting this button displays a ...

Page 16: ...14 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide The Blood Volume BV Graph The Crit Line screen showing BV and O2 Sat graphs ...

Page 17: ...ange is more than 3 and less than or equal to 6 5 per hour C BV change exceeds 6 5 per hour Current Hematocrit value Current estimated Hemoglobin value calculated from the current Hematocrit Hb Hct 2 94 Blood Volume Change The percent change in blood volume since the start of the treatment The BV change value is calculated from the following equation BV Hct initial Hct current 1 x 100 BV Alert Lev...

Page 18: ...16 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide The Oxygen O2 Saturation Graph The Crit Line screen showing BV and O2 Sat graphs ...

Page 19: ...ine across the Oxygen Saturation graph The following is displayed to the right of the Oxygen Saturation graph Feature Function Current Oxygen Saturation value Minimum Oxygen Saturation The minimum oxygen saturation value over all data points O2 Alert Level button This button sets the oxygen saturation alert level When the current O2 Sat value drops below the O2 Alert Level the alert message Oxygen...

Page 20: ...18 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide The Hematocrit Graph The Crit Line screen showing Hct and O2 Sat graphs ...

Page 21: ...emodialysis machine stops the UF pump and displays the alert message Rel Blood Volume Low The alert can be cleared by lowering the alert level or by setting the BV Alert Level to OFF After clearing the alert the UF pump will automatically turn back on to the UF Rate set on the Home screen To set the BV Alert Level select the BV Alert Level button and enter the desired value using the or up or down...

Page 22: ...20 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide The Blood Pressure Graph The Crit Line screen showing BV and Blood Pressure graphs ...

Page 23: ...M key to confirm the selection Reading the blood pressure graph on the Crit Line screen Similar to the Blood Pressure graph on the Trends and Blood Pressure screens the BP Blood Pressure graph is drawn as a series of black dumbbells between the systolic and diastolic blood pressures On the Crit Line screen the systolic upper and diastolic lower numbers are also displayed If the value is out of ran...

Page 24: ...22 P N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User s Guide Ending a CLiC Device Monitored Treatment ...

Page 25: ... S N The CLiC device s four digit serial number printed on the device s verification filter Patient ID The first 6 digits of the Test Options screen Patient ID number This is the unique identifier for this report Note If the Patient ID is fewer than 6 digits long or if there is no Patient ID this field will display six ones 111111 Hct start The initial hematocrit Hct value is recorded along with t...

Page 26: ...oth dampened with the cleaning solution do not spray the solution on the device Do not immerse the CLiC device in any type of liquid If liquids infiltrate the device they will damage it Caution Do not use abrasive materials or solvents to clean the CLiC device Doing so may damage the sensor Caution Be careful not to scratch or damage the verification filter If the verification filter is scratched ...

Page 27: ...events related to the use of the CLiC device that occur in the machine during operation The messages will reset when the condition causing them is corrected In some cases you must reset them yourself Warning Performing the recommended action may or may not clear the alert warning or advisory messages displayed An alert warning or advisory message may stop the UF Pump until the conditions causing t...

Page 28: ...the treatment starts Place the CLiC device on the verification filter which is attached to its USB cable Wait up to one minute for the message to clear If the message clears the CLiC device is verified If verification fails select the Test Options screen button and select the Verify Crit Line button to initiate the verification process manually If the message is still not cleared the CLiC device c...

Page 29: ... cable Make sure the cable is securely connected to the 2008T hemodialysis machine s USB port Wait up to one minute for the message to clear If the message is not cleared the CLiC device cannot be used for the dialysis treatment Disconnect the CLiC device cable from the USB port Press the Y key on the Keyboard to disable the CLiC device Contact a qualified service technician Crit Line Obstruction ...

Page 30: ... physiologic state The alert can be cleared by setting the O 2 Alert Level button on the Crit Line screen to OFF To turn the O 2 Alert level OFF select the O 2 Alert Level button enter 0 zero on the keyboard and press the CONFIRM key Note At the direction of a physician a new O 2 Alert Level can be selected To change the O 2 Alert Level select the O 2 Alert Level button enter the desired value usi...

Page 31: ...Alert Level can be selected To change the BV Alert Level select the BV Alert Level button enter the desired value using the keyboard and press the CONFIRM key Verify Failed The verification test shows that the CLiC device is not ready for use during treatment Advisory message Verify the CLiC device Place the CLiC device on the CLiC Verification Filter which is attached to its USB cable Wait up to ...

Page 32: ...e The CLiC device only needs calibration if verification fails in Dialysis Mode Calibration may extend the usable life of the CLiC device To calibrate the CLiC device plug the CLiC device USB cable into the USB port on the right side of the 2008T hemodialysis machine display screen located under the flap Power on the 2008T hemodialysis machine into Service Mode and go to the Options Calibrate Moni...

Page 33: ...official of the Company located in Waltham Massachusetts LIMITED WARRANTY The Company warrants to the Purchaser that the equipment delivered is free from defects in material or workmanship for the periods specified below provided the equipment is used and maintained in accordance with the original manufacturer s operating instructions The Crit Line in a Clip CLiC device shall be warranted for thre...

Page 34: ...HE EQUIPMENT AND ITS PARTS AS DESCRIBED ABOVE AND NO OTHER REMEDY INCLUDING WITHOUT LIMITATION CONSEQUENTIAL DAMAGES SHALL BE AVAILABLE TO THE PURCHASER The Company shall have no further obligation or liability with respect to the equipment or its sale operation and use and the Company neither assumes nor authorizes the assumption of any obligation or liability in connection with such equipment CL...

Page 35: ... 40 F to 257 F 40 C to 125 C Oxygen Saturation Instrument Range Accuracy Hct Accurate within 3 Accurate within 5 45 60 60 100 50 100 20 45 50 100 30 100 10 20 Not Specified 40 100 Hematocrit Instrument Range Accuracy 10 Hct 60 Hct 1 Hct SD Power 5 VDC MAX 0 36A USB bus powered Water Ingress Protection IPX0 CLiC device IPX1 2008T hemodialysis machine Anesthetic Suitability Not suitable Modes of Ope...

Page 36: ...uch an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air Level 3 6 kV contact 8 kV air Level 3 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV fo...

Page 37: ...mmended separation 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 occur in the vicinity of High Frequency Surgical Equipment such as electrocautery devices or other intentional radio frequency emitting equipment typically marked with the following s...

Page 38: ...3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the high...

Page 39: ......

Page 40: ... in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea cramping and vomiting The CLiC blood chamber is a sterile single use disposable optical cuvette designed for use with the CLiC monitor s sensor clip during acute and chronic hemodialysis therapy to non invasively measure hematocrit per...

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