1 year

Record the number of operating hours.

Replace the reusable sensor cables (RSCs).

1 year or 4000 hours

Microstream CO2 gas calibration – Check that there are no technical conditions like Sample line
disconnected, Warming up, Purging, Sample line blocked or Check Flow present as those might prevent
calibration check and calibration.

Microstream CO2 gas calibration – Check that the calibration is completed when the message
Calibration OK appears and the following information is updated: Operating hours to next calibration.

Microstream CO2 gas calibration – Check that the calibration is completed when the message
Calibration OK appears and the following information is updated: Date for next calibration.

Microstream CO2 gas calibration – Check that the calibration is completed when the message
Calibration OK appears and the following information is updated: Date and time of last calibration.

30 000 hours

Replace internal pump and IR sensor.

5 years

Replace the CARESCAPE rSO2 — INVOS parameter module.

2 years

Visual inspection – Check that all product labeling, markings and symbols are intact and readable.

Visual inspection – Check the monitor, connected devices, and device cables have no cracks or breaks,
dirt, loose connectors, corroded or bent pins, fluid contamination, or other visible damage.

Visual inspection – Check that the monitor and the connected devices are properly mounted with
specified mounting solutions.

Visual inspection – Check that all mounting solution fasteners are intact, properly tightened, and
correctly secured.

Visual inspection – Check that the power cord and power supply are properly secured.

Visual inspection – Check CARESCAPE Parameter cables and cable strain reliefs for abrasion and damage.

Visual inspection – Check that the CARESCAPE Parameters are properly connected.
Verifying power outlets – Verify that the power outlet is wired correctly according to the country’s
electrical code standard before starting the following electrical safety tests.

Verifying power cords and plugs – Verify that the power cords being used with the CARESCAPE Dock F0
are undamaged: Inspect the power cord for wear or damage.

Testing ground leakage current – (Set the NEUTRAL switch CLOSED and record the current with NORMAL
and REVERSE polarity) Verify that the recorded current is less than 1000µ.

Testing ground leakage current – (Set the polarity switch to NORMAL and the NEUTRAL switch OPEN)
Verify that the recorded current is less than 1000µ.

Testing chassis leakage current to the ePort connection – (Set the NEUTRAL switch CLOSED and record
the current with NORMAL and REVERSE polarity) Verify that the recorded current is less than 100µ.

Testing chassis leakage current to the ePort connection – (Set the GND switch OPEN) Verify that the
recorded current is less than 100µ.

Testing chassis leakage current to the ePort connection – (Set the polarity switch to NORMAL and the
NEUTRAL switch OPEN) Verify that the recorded current is less than 500µ.

Testing chassis leakage current to the Ethernet connection – (Set the NEUTRAL switch CLOSED and
record the current with NORMAL and REVERSE polarity) Verify that the recorded current is less than
100µ.

Testing chassis leakage current to the Ethernet connection – (Set the GND switch OPEN) Verify that the
recorded current is less than 100µ.

Testing chassis leakage current to the Ethernet connection – (Set the polarity switch to NORMAL and the
NEUTRAL switch OPEN) Verify that the recorded current is less than 500µ.

Testing patient source leakage current – (Set the NEUTRAL switch CLOSED and record the current with
NORMAL and REVERSE polarity) Verify that the recorded current is less than 10µ.

Testing patient source leakage current – (Set the polarity switch to NORMAL and the NEUTRAL switch
OPEN) Verify that the recorded current is less than 50µ.

Testing patient sink leakage current — system test – (Set the NEUTRAL switch CLOSED and NORMAL
polarity) Verify that the recorded current is less than 50µ.

Testing patient sink leakage current — system test – (Set the NEUTRAL switch CLOSED and REVERSE
polarity) Verify that the recorded current is less than 50µ.

Testing patient sink leakage current — system test – (Set the polarity switch to NORMAL and the
NEUTRAL switch OPEN) Verify that the recorded current is less than 50µ.

Testing patient sink leakage current — single CARESCAPE Parameter test – (Set the NEUTRAL switch
CLOSED and the OUTLET OFF) Verify that the recorded current is less than 50µ.

Testing patient sink leakage current — single CARESCAPE Parameter test – (Set the NEUTRAL switch
CLOSED and REVERSE polarity) Verify that the recorded current is less than 50µ.
Functional check – Testing the alarm light – Check the following: The power status indicator is lit.

Functional check – Testing the alarm light – Check the following: The blue, yellow and red alarm light
blinks.

Functional check – Testing the alarm light – Check the following: The blue pause audio alarm indicator
blinks.

Functional check – Checking the startup – Check that the monitor starts up normally: The green
on/standby button is lit.

Functional check – Checking the startup – Check that the monitor starts up normally: The start-up screen
briefly displays.

Functional check – Checking the startup – Check that the monitor starts up normally: The software
package and software version indicated in the welcoming screen are correct.

Functional check – Checking the startup – Check that the monitor starts up normally: The speaker gives
an audible beep.

Functional check – Checking the startup – Check that the monitor starts up normally: The normal
monitoring screen appears and there are no error messages on the screen.

Functional check – Checking the startup – Check that the monitor starts up normally: The language of
the clinical user interface is correct.

Functional check – Checking the startup – Check that the monitor starts up normally: The correct time
appears on the normal monitoring screen.

Functional check – Checking the startup – Check that the battery is fully charged.

Functional check – Checking picture quality – Check that all text is readable and all images are clear

Functional check – Checking picture quality – Check that the display brightness is adequate in the use
environment.

Functional check – Testing touchscreen control – Check the touchscreen operation, touch a corner of an
active parameter window.

Functional check – Testing touchscreen control – Check that the related menu is opened.

Functional check – Check the CARESCAPE Parameters identification.

Functional check – Checking the status of connected devices – Check that the power line frequency is
correctly configured according to the line frequency used in your country.

Functional check – Checking CARESCAPE SpO2 — Masimo identification and connection status – Check
for the SpO2 parameter identification: Confirm that at least one Pi/PVi or SpHb Masimo rainbow SET
parameter displays on the host monitor.

Functional check – Checking CARESCAPE SpO2 — Masimo identification and connection status – Check
the connected SpO2 device status: Check that the connected SpO2 device is correctly identified.
Functional check – Checking CARESCAPE rSO2 — INVOS identification and connection status – Check for
the rSO2 parameter identification: Confirm that the rSO2 parameter(s) display on the host monitor.

Functional check – Checking CARESCAPE rSO2 — INVOS identification and connection status – Check the
connected rSO2 device status: Check that the connected rSO2 device(s) are correctly identified.

Functional check – Checking that the CARESCAPE Dock F0 is charging a battery – Check that the battery
icon displayed in the upper right corner of the monitor’s screen indicates that the installed battery is
charging.

Functional check – Perform the making of connections for CARESCAPE ONE parameters functional check.

Functional check – Checking the battery status of the INVOS Field Test Device – Check that the LEDs next
to the Channel 1 and 2 illuminate.

Functional check – Perform the Configuring of the monitor for CARESCAPE parameters functional check.

Functional check – Perform the Configuring of simulator/manometer for CARESCAPE ONE parameters
functional check.

Functional check – Testing ECG measurement – Test for a normal sinus rhythm: Check that the monitor
displays the selected ECG leads and the waveforms are noise-free.

Functional check – Testing ECG measurement – Test for a normal sinus rhythm: Check that the monitor
displays a 80± 5 bpm heart rate and an audible QRS tone sounds with each QRS complex.

Functional check – Testing ECG measurement – Test for a normal sinus rhythm: (Flex the ECG cable near
the connectors) Verify no irregularities.

Functional check – Testing ECG measurement – Test for a normal sinus rhythm: Check that the selected
waveform displays and that it is noise free.

Functional check – Testing ECG measurement – Test for a normal sinus rhythm: (Repeat to display)
Check each of the remaining ECG leads: II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6.

Functional check – Testing ECG measurement – Check pacemaker detection: Check that pacemaker
spikes are shown on the ECG waveform.

Functional check – Testing ECG measurement – Check pacemaker detection: Check that the heart rate
value is 80± 5 beats per minute.

Functional check – Testing ECG measurement – Check Asystole detection: Check that the Asystole alarm
appears on the monitor screen.

Functional check – Testing ECG measurement – Check Asystole detection: Check that the heart rate
value is 80± 1 beats per minute.

Functional check – Testing ECG measurement – Check leads off detection: Check that the Lead II
waveform disappears from the ECG1 waveform field, followed by an RA/R lead off message.

Functional check – Testing ECG measurement – Check leads off detection: Check that Lead II is replaced
by Lead III in the ECG1 waveform field after a while.
Functional check – Testing ECG measurement – Check leads off detection: Check that Lead III is replaced
with Lead II in the ECG waveform field.

Functional check – Testing impedance respiration measurement – Check the respiration rate: Check that
the RESP waveform is shown.

Functional check – Testing impedance respiration measurement – Check the respiration rate: Check that
the RR value is 20 (±5) breaths per minute.

Functional check – Testing impedance respiration measurement – Check the apnea detection: Check
that the monitor activates an Apnea alarm.

Functional check – Testing impedance respiration measurement – Check the apnea detection: Check
that the RR value is 20 (±5) breaths per minute.

Functional check – Testing invasive pressure measurement – Zero the tested pressure channel: Ensure
that the simulator’s invasive pressure output channel is configured to 0 mmHg/0 kPa static.

Functional check – Testing invasive pressure measurement – Zero the tested pressure channel: Check
that a Zeroing message followed by a Zeroed message is shown in the related parameter windows.

Functional check – Testing invasive pressure measurement – Test a static pressure: Check that a flat
pressure line appears on the related waveform field.

Functional check – Testing invasive pressure measurement – Test a static pressure: Check that the
reading in the parameter window is 200 ± 4 mmHg/26.7 ± 0.5 kPa.

Functional check – Testing invasive pressure measurement – Check the pressure waveform: Check that
the pressure waveform for the tested invasive pressure channel appears in the waveform window.

Functional check – Testing invasive pressure measurement – Check the pressure waveform: Check that
the Art X Sys/Dia (Mean) pressure values 120/80 mmHg / 16/10.7 kPa are shown in the related
parameter window.

Functional check – Testing temperature measurement – Check that: Tx temperature matches the
configured simulator value chosen earlier ± 0.1 °C/ ± 0.2 °F.

Functional check – Testing temperature measurement – Check that: There are no error messages on the
screen.

Functional check – Testing SpO2 measurement – (For SpO2 with GE TruSignal, Masimo SET, and Nellcor
technologies) Check that: The SpO2 reading appears in the parameter window.

Functional check – Testing SpO2 measurement – (For SpO2 with GE TruSignal, Masimo SET, and Nellcor
technologies) Check that: The plethysmographic waveform appears on the screen.

Functional check – Testing SpO2 measurement – (For SpO2 with Masimo SET technology, flex the SpO2
cable near the connectors) Verify no irregularities.

Functional check – Testing SpO2 measurement – (For SpO2 with Masimo SET technology where some
features, such as Pi/PVi, or SpHb are licensed features of a host monitor that can only be measured on a
host monitor when the CARESCAPE ONE is used as an acquisition platform with a host monitor) Confirm
that the host monitor displays the following parameter data values: SpO2 = 81% +/- 0.3%.

Functional check – Testing SpO2 measurement – (For SpO2 with Masimo SET technology where some
features, such as Pi/PVi, or SpHb are licensed features of a host monitor that can only be measured on a
host monitor when the CARESCAPE ONE is used as an acquisition platform with a host monitor) Confirm
that the host monitor displays the following parameter data values: Pulse Rate = 61 bpm +/- 1 bpm.

Functional check – Testing SpO2 measurement – (For SpO2 with Masimo SET technology where some
features, such as Pi/PVi, or SpHb are licensed features of a host monitor that can only be measured on a
host monitor when the CARESCAPE ONE is used as an acquisition platform with a host monitor) Confirm
that the host monitor displays the following parameter data values: SpHb = 14g/dl +/- 1 g/dl.

Functional check – Testing rSO2 measurement – Check that the rSO2 parameter window is shown on the
host monitor screen.

Functional check – Testing rSO2 measurement – Check that a message L no sensor and R no sensor
message is shown on the parameter window.

Functional check – Testing rSO2 measurement – Check that the messages change from the Acquiring
signals messages to L sensor off and R sensor off messages.

Functional check – Testing rSO2 measurement – Check that for the channels L and R, the messages L
sensor off and R sensor off messages disappear from the parameter window, and the monitor indicates
the value 50 ± 2.

Functional check – Testing rSO2 measurement – Check that the values for the channels L and R change
to 70 ± 2 on the parameter window.

Functional check – Testing rSO2 measurement – Check that the blue LED starts blinking in the
CARESCAPE rSO2 — INVOS and on one of the reusable sensor cables.

Functional check – Testing rSO2 measurement – Check that the blue LED starts blinking in the
CARESCAPE rSO2 — INVOS and on the other reusable sensor cable.

Functional check – Testing LoFlo CO2 sample flow rate accuracy – Check that the flow rate is 50 ml/min
+/- 10 ml.

Functional check – Testing LoFlo CO2 accuracy – Check that the settings for CO2 are as follows: FiO2
level %: 21–40.

Functional check – Testing LoFlo CO2 accuracy – Check that the settings for CO2 are as follows: N20 level
%: 0–40.

Functional check – Testing LoFlo CO2 accuracy – Check the results: The CO2 value displayed should be
5.0 +/- 0.3%.

Functional check – Testing LoFlo CO2 accuracy – Check the results: If a waveform is present, the
waveform should appear as a straight line at approximately 5%.
Functional check – Testing Microstream CO2 measurement – Check the CARESCAPE CO2 — Microstream
startup: Check the following: The green LED on CARESCAPE CO2 – Microstream first starts blinking and
then remains lit.

Functional check – Testing Microstream CO2 measurement – Check the CARESCAPE CO2 — Microstream
startup: Check the following: The CARESCAPE CO2 – Microstream pump turns on for a moment.

Functional check – Testing Microstream CO2 measurement – Check the CARESCAPE CO2 — Microstream
startup: Check the following: The CO2 waveform field and the message Sample line disconnected
displays on the monitor screen.

Functional check – Testing Microstream CO2 measurement – Check the CARESCAPE CO2 — Microstream
startup: Check that the Sample line disconnected message disappears and the Microstream CO2 pump
turns on again.

Functional check – Testing Microstream CO2 measurement – Perform a CO2 accuracy check: Check that
the measured CO2 value is within the specified accuracy limits 4.7 – 5.3%.

Functional check – Testing NIBP measurement – Check that there is no leakage and NIBP is accurate.

Functional check – Testing NIBP measurement – Check that the pressure readings shown on the
Calibration Check menu and on the manometer are the same ± 1 mmHg.

Functional check – Testing NIBP measurement – Check that the pressure stabilizes and the readings
shown on the Calibration Check menu and does not drop at a rate of 1 mmHg or more for every five
seconds.

Functional check – Testing analog output and defibrillator synchronization marker out signals – Test
ECG: On the monitor, check that the V lead waveform resembles the primary ECG waveform.

Functional check – Testing analog output and defibrillator synchronization marker out signals – Test
invasive blood pressure: On the monitor, check that the V lead waveform resembles the BP waveform.

Functional check – Testing analog output and defibrillator synchronization marker out signals – Test
Marker Out: On the monitor, check that the V lead waveform has a marker pulse corresponding to the R
wave of the primary ECG waveform.

Functional check – Testing analog output and defibrillator synchronization marker out signals – Test
Marker In: On the monitor, check that the markers are present on the ECG waveform.

Functional check – Zeroing LoFlo CO2 to room air – Check that the CARESCAPE ONE is not displaying a
message indicating that the sensor is not ready to zero.

Functional check – Zeroing LoFlo CO2 to room air – Check that the maximum time for the LoFlo
Sidestream Module to zero is 40 seconds. The typical time for a zero is 15 to 20 seconds.