Medivance ARCTIC SUN Simply Advanced 5000, Руководство оператора

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TEMPERATURE MANAGEMENT SYSTEM
O P E R A T O R ’ S M A N U A L
• Do not place ArcticGel
™
Pads over an electrosurgical grounding pad.
The combination of heat sources may result in skin burns.
• If needed, place defibrillation pads between the ArcticGel
™
Pads and the
patient’s skin.
• Carefully remove ArcticGel
™
Pads from the patient’s skin at the completion
of use. Discard used ArcticGel
™
Pads in accordance with hospital
procedures for medical waste.
• The USB data port is to be used only with a standalone USB flash drive.
Do not connect to another mains powered device during patient treatment.
• Users should not use cleaning or decontamination methods different from
those recommended by the manufacturer without first checking with the
manufacturer that the proposed methods will not damage the equipment.
Do not use bleach (sodium hypochlorite) as it may damage the system.
• Medivance will not be responsible for patient safety or equipment
performance if the procedures to operate, maintain, modify or service the
Medivance Arctic Sun
®
Temperature Management System are other than
those specified by Medivance. Anyone performing the procedures must be
appropriately trained and qualified.
System Setup
Unpack
1) Unpack the Arctic Sun
®
Temperature Management System Control
Module and accessories.
2) Allow the control module to remain upright for at least 2 hours prior to
completing the installation and setup procedure in order to allow the chiller
oil to settle. Damage to the chiller compressor may result otherwise.
Connections
1) Use only Medivance approved cables and accessories with the
Arctic Sun
®
Temperature Management System Control Module.
Connect the Fluid Delivery Line, Patient Temp 1 cable, Patient Temp 2
cable (optional) and Fill Tube to the back of the control module.
2) Plug the Power Cord into the wall outlet. Position Arctic Sun
®
Temperature Management System so that access to the power
cord is not restricted.
Power On
1) Turn the power ON by activating the Power Switch.
2) The control module will automatically go through a brief self-test of the
independent safety alarm.
3) A New User Training module option is available from the start up screen.
4) When the self-test is complete, the Patient Therapy Selection screen
will appear on the control panel.
Fill Reservoir
1) Fill the reservoir with sterile water only.
2) Four liters of water will be required to fill the reservoir at
initial installation.
3) Add one vial of Arctic Sun
®
Temperature Management System Cleaning
Solution to the sterile water.
4) From the Patient Therapy Selection screen, press either the
Normothermia or Hypothermia button, under the New Patient heading.
5) From the
Hypothermia
or
Normothermia
therapy screen, press the
Fill Reservoir button.
6) The Fill Reservoir screen will appear. Follow the directions on
the screen.
Functional Verification
Perform the following functional verification procedure after initial setup
and installation of the control module.
1) Power
On
the control module
2) From the Patient Therapy Selection screen, press the Hypothermia
button to display the Hypothermia therapy screen.
3) From the Hypothermia therapy screen, press the Manual Control
button to open the Manual Control window.
4) Use the Up and Down arrows to set the
Manual Control
water target
temperature to 40°C and the duration to 30 minutes.
5) Press the Start button to initiate Manual Control . Allow at least
3 minutes for the system to stabilize.
6) Monitor the flow rate and water temperature in the System status area
on the
Hypothermia
therapy screen.
7) Verify that the flow rate reaches at least 1.5 liters/minute.
8) Verify that the water temperature increases to 30°C.
9) Press the Stop button.
10) Set the Manual Control water target temperature to 4°C and the duration
to 30 minutes.
11) Press the Start button to initiate Manual Control .
12) Monitor the flow rate and water temperature in the System status area
of the Hypothermia therapy screen. Verify that the water temperature
drops to 6°C.
13) Press the
Stop
button to stop
Manual Control
14) Press the Cancel button to close the Manual Control window
15) Power Off the control module.
Chapter 2 – Patient Therapy
Place ArcticGel
™
Pads
Read the Instructions for Use that accompany the ArcticGel
™
Pads.
Examine each pad for damage prior to placement.
Connect ArcticGel
™
Pads
Orient the blue and white colors on the pad line connector and Fluid
Delivery Line. While holding the pad line tubing, insert the clear pad line
connector into the Fluid Delivery Line manifold. Do not press or squeeze
the wings when connecting. The connector will click into place. Check the
surface of the device for mechanical damage prior to use.
Temperature Probe Placement
Patient temperature control with the Arctic Sun
®
Temperature Management
System requires patient temperature feedback provided by an indwelling
patient temperature probe connected to the Patient Temperature 1
connector on the back of the Control Module. Any commercially-available
Yellow Springs Instrument 400 Series (YSI 400) compatible patient
temperature probe can be connected to the Arctic Sun
®
Temperature
Management System. Refer to the manufacturer’s Instructions for Use
for the specific indications and temperature probe placement.
Power Switch
Patient
Temp
Out
Fluid
Delivery
Line
Power Cord
Equipotential
Stud
Patient
Temp 1
Strain Relief
Patient
Temp 2
Patient
Temp Cable
Fill Tube
Storage
Fill Tube/
Port
Drain Ports
Air Filter