Edwards HemoSphere Instrucciones De Uso página 2

HemoSphere Oximetry Cable Setup
Refer to the HemoSphere advanced monitor
operator's manual, available at eifu.edwards.com,
for comprehensive monitoring procedures with
that monitor.
1. Connect the HemoSphere oximetry cable to a
compatible monitor at the end indicated by ①
in figure.
2. Setup and initiate the compatible monitor.
3. Remove a section of the catheter tray lid to expose
the optical connector of a compatible catheter.
4. Connect the oximetry catheter optics connector
to the oximetry cable matching "TOP" on both
connections and snap the enclosure shut
(indicated by ② in figure).
5. Follow all instructions found in oximetry
catheter IFU for catheter preparation and
insertion procedures. The HemoSphere oximetry
cable must be calibrated before monitoring.
Calibration
Follow oximetry calibration procedure shown on the
screen prompts using the calibration type specified
in oximetry catheter IFU. The HemoSphere oximetry
cable can be calibrated prior to catheter insertion by
performing an in vitro calibration. When performing
an in vitro calibration, do so before preparing the
catheter (i.e. while still in packaging with the
calibration cup).
Caution: The catheter tip or calibration cup must not
get wet before an in vitro calibration is performed.
An in vivo calibration is required if an in vitro
calibration is not done. In vivo calibration may be
used to periodically recalibrate the cable. Refer to
the compatible monitor operator's manual and the
catheter's specification sheet for detailed
calibration instructions.
MRI Information
MR Unsafe
Do not use the HemoSphere oximetry cable in an
MR environment. The oximetry cable is MR unsafe
since the device contains metallic components,
which can experience RF-induced heating in the
MRI environment.
Specifications
Physical Specifications
Cable Length: 3.05 m (10 ft)
Parameter Measurement Specifications
Parameter Specification
ScvO
/SvO
Range
0 to 99%
2 2
Oximetry
1
Precision ±2% at 30 to 99%
(Oxygen
Update Rate 2 seconds
Saturation)
1
Precision tested under laboratory conditions.
HemoSphere Oximetry Cable Available Parameters List
Abbreviation Description
SvO mixed venous oxygen saturation
2
ScvO central venous oxygen saturation
2
HemoSphere Oximetry Cable with Swan-Ganz Module Available Parameters List
Abbreviation Description
DO oxygen delivery
2
DO I oxygen delivery index
2
VO oxygen consumption
2
VO I oxygen consumption index
2
estimated oxygen consumption
VO e
2
when ScvO is being monitored
2
estimated oxygen consumption
VO Ie index when ScvO
2
monitored
Operating Conditions
Temperature: 10 to 32.5 °C
Humidity range: 20 to 90% non-condensing
Altitude (Atmospheric Pressure): 0 m/0 ft
(1013 hPa) to 3048 m/10,000 ft (697 hPa)
IP Rating: IPX4
Maintenance
When unplugging the HemoSphere oximetry cable
from a compatible monitor or catheters from the
oximetry cable, always pull at the connection site.
Do not pull from cables or use tools to disconnect.
It is recommended to inspect the HemoSphere
oximetry cable periodically for signs of damage.
Check the condition of the cable and replace if any
of the following are present: exposed wire, splits,
cracks, or signs of stress. In addition, check that the
enclosure door (indicated by ② in figure) moves
freely and latches properly. Do not use the
oximetry cable if the door is damaged, open, or
missing. If the door becomes damaged, contact
technical assistance.
The oximetry cable is a multi-use device and can be
surface cleaned using a cloth dampened with
cleaning agents containing 70% isopropyl alcohol,
2% glutaraldehyde, 10% bleach solution, or
quaternary ammonium solution. The fiber-optic
interface of the oximetry cable must be kept clean.
Moisten a lint-free, cotton-tipped applicator with
cleaning alcohol and apply gentle pressure to clean
the optical fibers recessed within the front of the
oximetry cable housing (within enclosure indicated
by ② in figure).
Cautions:
Do not use any other cleaning agents, spray, or pour
cleaning solution directly on the oximetry cable.
Do not steam, radiation or EO sterilize.
Do not immerse.
2
Sub-System
Technology Used
HemoSphere
oximetry cable
Sub-System
Technology Used
HemoSphere
oximetry cable
and HemoSphere
Swan-Ganz
module
is being
2
Storage
Store in a cool, dry place in original packaging
to prevent damage.
Caution: Do not coil the cable against its natural
orientation or coil the cable tightly.
Temperature: -18 to 45 °C
Relative humidity: 90% non-condensing at 45 °C
Altitude: 0 to 20,000 feet (6096 m)
Technical Assistance
For technical assistance, please call Edwards
Technical Support at the following telephone
numbers:
Inside the U.S. and Canada
(24 hours): . . . . . . . . . . . . . . . . . . . . . . 800.822.9837
Outside the U.S. and Canada
(24 hours): . . . . . . . . . . . . . . . . . . . . . . 949.250.2222
In the UK: . . . . . . . . . . . . . 0870 606 2040 - Option 4
In Ireland: . . . . . . . . . . . . . . . . . 01 8211012 Option 4
Notices
Caution: Federal (USA) law restricts this device
to sale by or on the order of a physician.
Users and/or patients should report any serious
incidents to the manufacturer and the Competent
Authority of the Member State in which the user
and/or patient is established.
Prices, specifications and model availability are
subject to change without notice.
Refer to the symbol legend at the end of this
document.
Patient Hospital
Population Environment
operating room,
adult and
intensive care unit,
pediatric
emergency room
Patient Hospital
Population Environment
operating room,
adult and
intensive care unit,
pediatric
emergency room