Glossary

Indicates the time available for patient monitoring in hours on the ‘Ready for Use’ screen, i.e., the time interval after removing the sensor from the Docking Station or applying the sensor to the patient until the ‘Preset Site Time’ or – if PCO2 is enabled – until the ‘Calibration Interval’ elapses (whichever occurs first).

• Built-in sensor calibration chamber in SDM for 1-point calibration

• Automatic calibration ensures that system is always ready for use when V-Sign™ Sensor is stored in calibration chamber

• Calibration Interval (after stabilization) is typically 12 hours for V-Sign™ Sensor 2

Calibration Interval (after stabilization) is typically 12 hours for V-Sign™ Sensor 2.

difference between current reading and reading 10 minutes ago (available for tcPCO2 and SpO2)

difference between current reading and reading at the time baseline was set (available for tcPCO2 and SpO2).

Conventionally, ventilation is monitored by arterial blood sampling (ABG) or by (sidestream) etCO2.

• ABG:
  • Intermittent, spot check measurements only, not continuous
  • Invasive

• etCO2:
  • Depends on healthy lungs, good lung perfusion/ventilation, gas sampling quality, and a regular/full breathing cycle

Important examples where etCO2 is difficult to use or cannot be used include monitoring of:

• spontaneously breathing patients and, in particular, patients undergoing surgical or therapeutic procedures that affect the upper airway (e.g. upper gastro-intestinal procedures)
• non-invasively ventilated patients (e.g. gas leaks at mask/patient interface)
• patients being ventilated with non-traditional techniques
• patients during and after weaning from mechanical ventilation
• neonatal patients

Transcutaneous pCO2 (tcpCO2) monitoring is continuous, noninvasive, and independent from the quality of the airway. This method provides accurate PaCO2 estimations and overcomes the drawbacks of etCO2 and the invasiveness of ABGs.

After downloading/importing measurement data V-STATS™ automatically analyzes the data, using the analysis criteria that are currently active.
Colored markers highlight the detected events on the graphs. User-defined event markers – set during measurement as many time as desired – are displayed as triangles above the graph window of the corresponding measurement curve. The following event types can be distinguished:

• PCO2-related events: upper/lower thresholds, fall/rise, baseline ranging
• SpO2-related events: desaturation, upper/lower threshold
• PR-related events: upper/lower thresholds, rise
• Invalid measurement periods (e.g. «Sensor off patient»)
• SDM (monitor) events (e.g. «Calibrate sensor», «SpO2 low signal», etc.)
• Artifacts (e.g. SpO2 below a predefined level)
• Operator marked (by Quick Access Menu on the SDM)

Feature which temporarily increases sensor temperature after sensor application (default setting: OFF; operator access requires institution’s permission [password protected]).

The temporary limited increase in sensor temperature does not increase the risk of skin irritations and yet is sufficient for many patients to stimulate and accelerate arterialization of the local capillary blood flow. Once local blood flow is stimulated it can often be maintained at a level sufficient to obtain a close correlation between PaCO2 and tcPCO2 at lower temperatures.

Please refer to the respective Table in the Quick Reference Guide.

Maximal Operator-Selectable Preset Site Time (MOS-PST):

• Institution-selectable (password protected) from 0.5 to 12.0 hours (in increments of 0.5 hours; factory default = 12.0 hours)
• Decreases with increasing Sensor SET Temperature

Operator-selectable: 0.5 hours to MOS-PST (in 0.5 hour increments)
Default Preset Site Time (after changing patient mode):

• 8.0 hours (or MOS-PST if MOS-PST < 8 hours) in Adult Mode at 42.0 °C or in Neonatal Mode at 41.0 °C
• Decreases with increasing Sensor SET Temperature

using V-STATS™ 3.01 within a password protected area

• all menu-parameters as well as all so-called special (safety relevant) parameters can be configured on an individual basis.
  • Note: Special (safety relevant) parameters cannot be changed in the menu of the SDM. Several of these parameters permit to disable or restrict operator-access to certain menu-parameters. Examples include the restriction of the ‘Maximal selectable Sensor Temperature’, restriction of the ‘Maximal selectable Site Time’ or enabling/disabling the possibility that the operator can switch-off the ‘AUDIO OFF Reminder’ in the menu of the SDM.
• the ‘Profile Mode’ of an SDM with firmware version SMB-SW V07.00 or higher can be selected:
• In ‘Basic Mode’ the SDM at power-up maintains the parameter settings from previous use and the SDM menu ‘Profile’ is not accessible.
• In ‘Institutional Mode’ the Responsible Organization can store up to 4 SDM Profiles in the connected SDM and select one of these profiles as ‘Standard Profile’. If modified the operator can at any time restore the ‘Standard Profile’ in the menu of the SDM. The profile name is shown on the display.
• Various preconfigured SDM Profiles are available within a password protected area of V-STATS™ (Sleep, NICU, ICU, HOME, V-CHECK, etc.)

• Maximal Operator-Selectable Sensor SET Temperature (MOS-SST):
  • Institution-selectable (password protected) from 39.0 °C to 43.5 °C (in increments of 0.5 °C; factory default = 42.0 °C)
  • In Neonatal Mode restricted to 43.0 °C by firmware

• Operator selectable: 39.0 °C – MOS-SST (in 0.5 °C increments)

• Default Sensor SET Temperature (after changing patient mode):
  • In Adult Mode: 42.0 °C or MOS-SST if MOS-SST < 42.0 °C
  • In Neonatal Mode: 41.0 °C or MOS-SST if MOS-SST < 41.0 °C

Safety feature which reduces sensor temperature once Preset Site Time has elapsed (default setting: ON; operator access requires institution’s permission [password protected]).

• Indicates remaining monitoring time
• Triggers an alarm once monitoring time has elapsed.
  
  

Feature which significantly reduces the number of required sensor calibrations. Calibration status maintains when sensor is disconnected for up to 30 minutes.

• SDM firmware redundantly controls temperature of connected sensor
• Restarts or switches OFF sensor in case of error

Pulse oximetry is an excellent means of continuously and noninvasively assessing patient oxygenation on the general care floor and helps avoid hypoxemia and tissue hypoxia. Furthermore, in patients who are breathing room air, pulse oximetry is – to a certain extent – an indirect indicator of hypoventilation. However, due to the physiology of the Hb-oxygen dissociation curve, pulse oximetry is NOT able to detect hypoventilation when supplemental oxygen is administered. In patients receiving supplemental oxygen and being monitored with pulse oximetry only, respiratory depression consequently may develop and deteriorate, remaining unnoticed until critical levels are reached.

using V-STATS™ 3.01 within a password protected area

• all menu-parameters as well as all so-called special (safety relevant) parameters can be configured on an individual basis.
  • Note: Special (safety relevant) parameters cannot be changed in the menu of the SDM. Several of these parameters permit to disable or restrict operator-access to certain menu-parameters. Examples include the restriction of the ‘Maximal selectable Sensor Temperature’, restriction of the ‘Maximal selectable Site Time’ or enabling/disabling the possibility that the operator can switch-off the ‘AUDIO OFF Reminder’ in the menu of the SDM.
• the ‘Profile Mode’ of an SDM with firmware version SMB-SW V07.00 or higher can be selected:
• In ‘Basic Mode’ the SDM at power-up maintains the parameter settings from previous use and the SDM menu ‘Profile’ is not accessible.
• In ‘Institutional Mode’ the Responsible Organization can store up to 4 SDM Profiles in the connected SDM and select one of these profiles as ‘Standard Profile’. If modified the operator can at any time restore the ‘Standard Profile’ in the menu of the SDM. The profile name is shown on the display.
• Various preconfigured SDM Profiles are available within a password protected area of V-STATS™ (Sleep, NICU, ICU, HOME, V-CHECK, etc.)