ScvO2 measurement CARESCAPE Users Manual Addendum

Addendum

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File Name: GE Healthcare - ScvO2 measurement CARESCAPE Users Manual Addendum.pdf

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ScvO₂ measurement Addendum for CARESCAPE Modular Monitors user documentation

Due to continuing product innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc. and GE Healthcare Finland Oy.

ScvO₂ measurement

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Contents Intended use of this addendum ... 5 ScvO₂ safety precautions ... 5 ScvO2 warnings ... 5 ScvO2 measurement limitations... 5 ScvO2 points to note ... 5 ScvO2 measurement description ... 6 ScvO₂ measurement setup... 6 ScvO2 equipment to patient connection... 6 Checking the ScvO2 measurement ... 6 Using the ScvO₂ measurement ... 7 ScvO2 calibration procedure... 7 Selecting the ScvO2 measurement ... 7 Setting the ScvO2 alarms ... 7 ScvO2 troubleshooting ... 7 ScvO2 cleaning and care instructions... 8 Messages related to ScvO2 measurement ... 8 ScvO2 broadcast only alarms ... 9 ScvO₂ alarm specifications... 9 ScvO2 physiological alarm specifications ... 9 ScvO2 technical alarm delays... 9 ScvO2 alarm priorities and escalation times ... 10 ScvO2 abbreviations... 10 ScvO2 default settings... 10 ScvO₂ specifications ... 11 E-COPSv performance specifications ... 11 ScvO2 performance specifications... 11 ScvO2 compatibility... 11 ScvO2 accessories... 12 ScvO2 skills checklist ... 12

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Intended use of this addendum This addendum must be used in conjunction with the CARESCAPE Modular Monitors User's Manual for important safety information regarding the whole system, for information regarding cleaning and care, and for information regarding the SvO2 measurement. The addendum must also be used in conjunction with the CARESCAPE Modular Monitors Supplemental Information Manual for information regarding the module performance specifications. Make sure the addendum is stored with these manuals. Before using the ScvO2 measurement, familiarize yourself with the mixed venous oxygen saturation (SvO2 ) instructions in the CARESCAPE Modular Monitors User's Manual, as this addendum only contains ScvO2–specific information. This addendum is to be used with the following products: ●

E-COP-00

●

E-COPSv-00

●

E-COPSv-01

ScvO₂ safety precautions ScvO2 warnings Before using this measurement also familiarize yourself with all safety precautions related to SvO2 measurement. WARNING

- MISSED ALARM - Do not rely on receipt of the following alarm conditions at a central station, remote bedside, or alarm notification device when connected to the CARESCAPE Network. Notification of any of these alarms will only be given when it is the most recent, highest priority active alarm coming from the bedside monitor. This applies to the following alarms: ● ScvO2 high ScvO2 low ● ScvO2 signal poor ●

ScvO2 cable off ● ScvO2 measurement removed

●

ScvO2 measurement limitations ●

The ScvO2 measurement is not intended for neonatal patients.

ScvO2 points to note

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●

This equipment is suitable for use in the presence of electrosurgery, as tested according to IEC 60601-2-49 clause 202.6.2.101 Electrosurgery interference.

●

Follow the catheter manufacturer's instructions for inserting the catheter.

●

Follow your care unit’s policy and procedures for obtaining the ScvO2 measurements and performing the calibration.

ScvO₂ measurement

●

Correct ScvO2 measurements depend on the Hb values. Therefore, re-calibration should be performed regularly in such clinical circumstances where the Hb values change rapidly (e.g. due to bleeding).

●

Monitor software version 2.0.8 or later: You can measure CCO and ScvO2 simultaneously when CCO is measured with the E-PiCCO and ScvO2 with the E-COPSv-01. Only the optical module should be connected to the E-COPSv-01 during this monitoring combination.

ScvO2 measurement description Central venous oxygen saturation (ScvO2) is a continuous measurement of venous oxygen saturation in central venous blood. ScvO2 measures the percentage of hemoglobin carrying oxygen in the venous blood compared to the total binding capacity measured in central venous blood. It reflects how much oxygen was consumed by body tissues. In contrast, SpO2 reflects the oxygen content of arterial blood, which has not yet given up its oxygen to body tissues (reflects the amount of O2 available to tissues). For more information, see the measurement description for SvO2 in the user manual.

ScvO₂ measurement setup ScvO2 equipment to patient connection

Module E-COPSv-01

Optical module

Optical connector

Central venous oximetry catheter

Checking the ScvO2 measurement 1.

Check that the ScvO2 value is displayed when the catheter is inserted in the patient (always perform in vitro calibration first), the measurement has been started and the Warming up message has disappeared.

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Check the position of the catheter regularly.

Calibrate in vivo and update the Hb value at least every 24 hours. Correct ScvO2 measurements depend on the Hb values. Therefore, re-calibration should be performed regularly in such clinical circumstances where the Hb values change rapidly (e.g. due to bleeding).

Using the ScvO₂ measurement ScvO2 calibration procedure The ScvO2 calibration procedure is similar to the SvO2 calibration. Refer to the user’s manual for detailed instructions. Note that with the ScvO2 measurement some of the menu selections will refer to the ScvO2 instead of the SvO2.

Selecting the ScvO2 measurement To start the ScvO2 measurement, first select the measurement type accordingly. This will give you the correct label in the measurement values. The selection is available only if the E-COPSv module version supports the measurement. 1.

Select the ScvO2 parameter window.

Select the Calibration tab.

Select ScvO2 from the Measurement Type list.

Setting the ScvO2 alarms 1.

Select the ScvO2 parameter window.

Select the Alarms tab. If alarms have been set to Alarm Off, the alarm limits are greyed out. Select Alarm On to set the alarms.

Set the alarm limits.

ScvO2 troubleshooting Problem

Solution

ScvO2 measurement is not available

● Make sure that the module supports ScvO2 measurement (E-COPSv-01).

ScvO2 levels are too high

● Select the ScvO2 measurement type. ● Position the catheter correctly. ● Calibrate in vivo.

In vivo calibration fails

● Check the connections. ● Check that the optical cables have no sharp bends. ● If the in vivo calibration fails again, replace the catheter and/or the

optical module, and repeat the procedure.

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ScvO2 cleaning and care instructions Refer to the cleaning and care instructions given in the user’s manual.

Messages related to ScvO2 measurement Also check the SvO2 related messages in the user’s manual. Message

Location

Explanation

What to do

● Identical IP8 modules

● al. area

There is one E-PiCCO and one E-COP-01 or E-COPSv-01 module in the system with their IP8 cables connected.

● Remove one of the modules,

or disconnect one IP8 cable.

This message appears with monitor software version 2.0.8 or later only. ● Re-calibrate ScvO2

● al. area,

param. ● ScvO2 cable off ● ScvO2 faulty cable

● al. area ● al. area,

The calibration is over 24 hours old.

● Perform in vivo calibration.

The cable is disconnected from the module.

● Re-connect the cable to the

The optical module has failed.

● Check the optical module and

param.

module. connections. ● Replace the optical module.

● ScvO2 high / ScvO2

● al. area

low

Measurement values are equal to or outside the alarm limits.

● Check the patient status. ● Adjust alarm limits if

necessary. ● ScvO2 measurement

● al. area

removed ● ScvO2 not calibrated

● al. area,

param. ● ScvO2 out of range

● param.

Acquisition module has been removed.

● Connect the module if

The optical module is connected to the monitor and the catheter has not been calibrated.

● Perform in vivo calibration.

Values are above or below the range the monitor can process.

● Check cables and

you want to restart the measurement.

connections. ● Repeat in-vivo calibration. ● Change the optical module. ● If the catheter is faulty,

replace it. ● If the cable or module is

broken, contact authorized service personnel. ● ScvO2 signal poor

● al. area,

param.

There is signal pulsation, the catheter is touching the wall, or there is an intensity shift in signal quality level.

● Flush the catheter. ● Check the optical module and

connections. ● Check the catheter

placement.

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Message

Location

Explanation

What to do

● ScvO2 temp error

● al. area

The temperature of the optical module is out of range for more than 10 minutes.

● Check the optical module and

connections. ● Replace the optical module. ● Contact authorized service

personnel. ● param.

● Start ScvO2

Displays when the catheter has been inserted into the patient after in vitro calibration.

● Select the Start ScvO2 option

from the SvO2/ScvO2 menu.

ScvO2 broadcast only alarms Alarms are sent to the CARESCAPE Network and displayed on the central station or remote monitor according to the following mapping: Message on the bedside monitor

Message sent to the CARESCAPE Network and displayed on the central station/remote monitor

Identical IP8 modules

IDENTICAL IP

This message appears with monitor software version 2.0.8 or later only. ScvO2 cable off

SCVO2 CBL OFF

ScvO2 high

SCVO2 HIGH

ScvO2 low

SCVO2 LOW

ScvO2 measurement removed

SCVO2 REMOVED

ScvO2 signal poor

SCVO2 POOR SG

ScvO₂ alarm specifications ScvO2 physiological alarm specifications Alarm

Limit range

Limit increment

Alarm delay

ScvO2 high

21% to 98%

10 s

ScvO2 low

20% to 97%

10 s

ScvO2 technical alarm delays Alarm

Alarm delay

Identical IP8 modules

2.1 s

This message appears with monitor software version 2.0.8 or later only. Re-calibrate ScvO2

24 hours from the last calibration

ScvO2 cable off

7.1 s

ScvO2 faulty cable

<1 s

ScvO2 measurement removed

2.9 s

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Alarm

Alarm delay

ScvO2 not calibrated

120 s ±1 s

ScvO2 signal poor

36.7 s ±1 s

ScvO2 temp error

600 s ±1 s

ScvO2 alarm priorities and escalation times Also familiarize yourself with the alarm priorities and escalation times for SvO2. Alarm

Priorities and escalation times info

low

medium

high

Identical IP8 modules This message appears with monitor software version 2.0.8 or later only. Re-calibrate ScvO2

0s 5s

ScvO2 cable off ScvO2 faulty cable

0s 10 s if sensor not calibrated

ScvO2 high / ScvO2 low ScvO2 measurement removed

0 s if no patient case/ no admitted patient

10 s if sensor calibrated

72 s if sensor calibrated

0 s if active patient case / admitted patient 120 s

ScvO2 not calibrated ScvO2 out of range

ScvO2 signal poor

30 s

ScvO2 temp error Start ScvO2

30 s

120 s

600 s 0s

ScvO2 abbreviations Hb

hemoglobin

Lab

laboratory

ScvO2

central venous oxygen saturation

SvO2

mixed venous oxygen saturation

ScvO2 default settings Select Monitor Setup > Parameter Setup > SvO2/ScvO2 > Calibration to adjust the following factory default settings for the current patient. The following factory default settings are for the E-COPSv module. The E-COPSv–01 module is the default acquisition module for this parameter.

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ICU

NICU

PACU

Setting

Description

Measurement Type

Select the measurement type: ScvO2 or SvO2.

SvO2

Not applicable.

SvO2

Lab SvO2 %

Select the initial SvO2 value.

Not applicable

Lab Hb g/l1

Select the initial Hb value.

115

Not applicable

115

Update Hb g/l2

Select the initial Hb value.

115

Not applicable

115

Select Monitor Setup > Parameter Setup >SvO2/ScvO2 > Alarms to adjust the following factory default settings for the current patient. Setting

Description

ICU

NICU

PACU

ScvO2 alarm limits

Select the high/low alarm limits.

85/55

Not applicable

85/55

ScvO2 alarms on/off

Enable alarm when limits are violated.

Alarm On

Not applicable

Alarm On

ScvO₂ specifications E-COPSv performance specifications Refer to the E-COPSv performance specifications given in the supplemental information manual.

ScvO2 performance specifications NOTE

The ScvO2 measurement is not intended for neonatal patients.

ScvO2 saturation value range

E-COPSv–01 modules: 1 to 98%

ScvO2 saturation value accuracy

E-COPSv–01 modules: ±2% ScvO2 equals 1 standard deviation for range of 30% to 95% ScvO2 and 6.7 to 16.7 g/dl Hb when using in vivo calibration

ScvO2 saturation value display resolution

E-COPSv–01 modules: 1%

Supported ScvO2 catheters

E-COPSv–01 modules: Edward Lifesciences Corp. ScvO2 catheters and optical modules

ScvO2 compatibility The ScvO2 measurement is available with the following monitors and software versions: ● 1. 2.

CARESCAPE Monitor B850, software version 2

Depending on the unit of measure selected, this setting could also be Lab Hb g/dl or Lab Hb mmol/l. Depending on the unit of measure selected, this setting could also be Update Hb g/dl or Update Hb mmol/l.

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ScvO₂ measurement

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CARESCAPE Monitor B650, software version 2

●

CARESCAPE Monitor B450, software version 2

The ScvO2 measurement is available with the E-COPSv–01 module. E-COPSv–01 supports the catheters and accessories listed as ScvO2 supplies and accessories by GE.

ScvO2 accessories The following catheters can be used for the ScvO2 measurement. For more information regarding other possibly compatible catheters, please contact Edwards Lifesciences Corp. Part Number

ScvO2 Accessory Description

Approved for use with

165790

Optical Module Type: Edwards OM-2E

E-COPSv-00 and E-COPSv-01

Available from Edwards Lifesciences Corp

PreSep oximetry cather CDC kit, model X3820HKCDC

E-COPSv-01

Available from Edwards Lifesciences Corp

PreSep oximetry cather CDC kit, model X3816HKC

E-COPSv-01

Available from Edwards Lifesciences Corp

PediaSat oximetry cather kit, model XT245HK

E-COPSv-01

Available from Edwards Lifesciences Corp

PediaSat oximetry cather kit, model XT3515HS

E-COPSv-01

ScvO2 skills checklist To familiarize yourself with this parameter and its use with the CARESCAPE modular monitors, study the topics listed as the recommended reading in this addendum and also the topics listed for SvO2 in the user’s manual. The numbers in brackets refer to the page numbers in this addendum. As you proceed, mark your completed tasks in the table. Recommended reading

Completed

Not applicable

GENERAL MEASUREMENT OVERVIEW ● ScvO2 warnings (5) ● ScvO2 measurement

limitations (5) ● ScvO2 points to note (5) ● ScvO2 equipment to

patient connection (6)

ScvO₂ measurement

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GE Healthcare

CARESCAPE Monitors

ScvO2 measurement CARESCAPE Users Manual Addendum