Stryker altrix Operation Manual
Altrix™ Precision Temperature Management System
8001
Operations Manual
2016/12 G.1 8001-009-001 REV G
www.stryker.com
sample text
Symbols
~
ONLY
Refer to instruction manual/booklet
General mandatory action sign
Consult instructions for use
General warning
Caution
Warning; electricity
Catalogue number / model
IPX1
Serial number
For US Patents see www.stryker.com/patents
Manufacturer
Mass of equipment
Direct current
Alternating current
Product provides terminal for connection of a potential equalization conductor. The potential
equalization conductor provides direct connection between the product and potential
equalization busbar of the electrical installation.
Protective earth ground
Protection from dripping water from above the device
Defibrillation proof type BF applied part
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
www.stryker.com 8001-009-0 01 REV G
87VL Medical
Electrical Equipment
Symbols
CAUTION
Always use sterile distilled water or water that has been passed through a filter less than or
equal to 0.22 microns with this product.
In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic
Equipment, this symbol indicates that the product must not be disposed of as unsorted
municipal waste, but should be collected separately. Contact your local distributor for disposal
information.
Medical Equipment Classified by Underwriters Laboratories Inc. with Respect to Electric Shock,
Fire, Mechanical and Other Specified Hazards Only in Accordance with IEC 60601-1:20 05 (3rd
edition), ANSI/AAMI ES60601-1 (2005, 3rd edition), CAN/CSA C22.2 No. 60601-1:20 08, IEC
80601-2-35:2009, CAN/CSA C22.2 NO 80601-2-35:12, ISO 80601-2-56:2009, CAN/CSA C22.2
NO 80601-2-56:12, IEC 60601-1-8:2007, CAN/CSA C22.2 NO 60601-1-8-08, IEC 60601-110:2008, CAN/CSA C22.2 NO 60601-1-1 0-09, IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-16:11
Liquid level indicator
Fragile, handle with care
Keep dry
Do not stack
This way up
8001-009-0 01 REV G www.stryker.com
Table of Contents
Warning/Caution/Note Definition...................................................................................................................4
Summary of safety precautions ....................................................................................................................5
Introduction..............................................................................................................................................7
Product description..............................................................................................................................7
Indications for use ...............................................................................................................................7
Intended users.................................................................................................................................... 8
Expected service life ............................................................................................................................ 8
Contraindications................................................................................................................................. 8
Specifications..................................................................................................................................... 8
Product illustration ............................................................................................................................. 10
Product system ................................................................................................................................. 11
Product functions .............................................................................................................................. 12
Buttons ..................................................................................................................................... 12
Visual indicators.......................................................................................................................... 13
Graphical user interface icons........................................................................................................ 14
Product alarms ................................................................................................................................. 15
Alarm priority and description ......................................................................................................... 15
Contact information............................................................................................................................ 18
Serial number location........................................................................................................................ 18
Date of manufacture .......................................................................................................................... 18
Setup.................................................................................................................................................... 19
Inspecting........................................................................................................................................ 19
Selecting a language.......................................................................................................................... 19
Testing visual and audible alarms ......................................................................................................... 19
Operation .............................................................................................................................................. 21
Placing the product............................................................................................................................ 21
Applying or releasing the wheel locks..................................................................................................... 21
Selecting and connecting a temperature probe ........................................................................................ 22
Connecting the reusable patient temperature output cable ......................................................................... 22
Connecting the insulated hoses............................................................................................................ 23
Disconnecting the insulated hoses ........................................................................................................ 24
Connecting and disconnecting thermal transfer devices............................................................................. 24
Powering on the product ..................................................................................................................... 25
Removing and replacing the reservoir .................................................................................................... 26
Filling the reservoir with sterile distilled water........................................................................................... 26
Selecting and setting the primary probe.................................................................................................. 27
Filling a thermal transfer device............................................................................................................ 28
Selecting a therapy mode.................................................................................................................... 28
Starting Automatic therapy mode .......................................................................................................... 29
Setting or editing the cooling rates......................................................................................................... 29
Setting or editing the warming rates.......................................................................................................30
Starting Manual mode ........................................................................................................................ 30
Starting Monitor mode ........................................................................................................................ 31
www.stryker.com 8001-009-0 01 REV G 1
Table of Contents
Switching modes............................................................................................................................... 31
Pausing and resuming therapy .............................................................................................................31
Displaying the data storage.................................................................................................................. 31
Opening and securing items in the storage compartment ........................................................................... 32
Stopping therapy or powering off the product........................................................................................... 33
Draining the thermal transfer devices..................................................................................................... 33
Draining water from the reservoir .......................................................................................................... 33
Draining water from the controller and hoses........................................................................................... 34
Storing the power cord and hoses......................................................................................................... 35
Storing the controller .......................................................................................................................... 35
Transporting the product..................................................................................................................... 36
Cleaning................................................................................................................................................ 37
Cleaning the external surfaces............................................................................................................. 37
Disinfecting ............................................................................................................................................ 38
Disinfecting external surfaces .............................................................................................................. 38
Disinfect the internal water circuit and hoses every 14 days........................................................................ 39
Draining the internal water circuit and hoses for disinfection ....................................................................... 39
Disinfecting the internal water circuit and hoses ....................................................................................... 41
Rinsing the internal water circuit and hoses............................................................................................. 43
Accessories ........................................................................................................................................... 45
Thermal transfer devices .................................................................................................................... 45
Thermal transfer device kits................................................................................................................. 45
Patient temperature probes ................................................................................................................. 46
Cables ............................................................................................................................................ 46
Hoses ............................................................................................................................................. 46
Troubleshooting ...................................................................................................................................... 47
Preventive maintenance............................................................................................................................ 49
Cleaning tools......................................................................................................................................... 50
Alarm conditions...................................................................................................................................... 51
Check patient probe alarm .................................................................................................................. 51
Patient probe malfunction alarm ........................................................................................................... 52
Patient probe disconnect alarm ............................................................................................................ 52
Patient temperature deviation medium alarm ........................................................................................... 52
Patient temperature output deviation alarm ............................................................................................. 52
Normothermia deviation alarm.............................................................................................................. 52
Water temperature deviation alarm group ............................................................................................... 52
Check water flow alarm ...................................................................................................................... 53
Power backup level alarm ................................................................................................................... 53
Therapy paused time out alarm ............................................................................................................ 53
Remove from use mode...................................................................................................................... 54
EMC Information ..................................................................................................................................... 55
Warranty ............................................................................................................................................... 59
Warranty exclusion and damage limitations............................................................................................. 59
2 8001-009-001 REV G www.stryker.com
Table of Contents
To obtain parts and service.................................................................................................................. 59
Return authorization........................................................................................................................... 59
Damaged product.............................................................................................................................. 59
International warranty clause ............................................................................................................... 59
www.stryker.com 8001-009-0 01 REV G 3
Warning/Caution/Note Definition
The words WARNING, CAUTION , and NOTE carry special meanings and should be carefully reviewed.
WARNING
Alerts the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe
potential serious adverse reactions and safety hazards.
CAUTION
Alerts the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the
user or patient or damage to the product or other property. This includes special care necessary for the safe and
effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or
misuse.
Note: Provides special information to make maintenance easier or important instructions clearer.
4 8001-009-001 REV G www.stryker.com
Summary of safety precautions
Always read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.
WARNING
• Always turn or re-position the patient over the duration of therapy, if possible, to reduce the risk of pressure ulcers.
Follow your hospital protocol.
• Always check the integrity of the patients skin and temperature according to hospital protocol when using the Altrix
system.
CAUTION
• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in
this manual.
• Do not modify the product or any components of the product. Modifying the product can cause unpredictable
operation resulting in injury to patient or operator. Modifying the product also voids its warranty.
• Shock Hazard - Improper handling of the power cord may damage the power cord and cause potential shock
hazards. If damage has occurred to the power cord, immediately remove the temperature management system from
service to avoid the risk of serious injury or death. Contact the appropriate maintenance personnel.
• Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment
like Altrix. Install and place Altrix into service according to the EMC information located in the EMC section of this
manual. Portable and mobile RF communications equipment can affect the function of Altrix.
• Shock Hazard. If the internal electrical components are exposed, because the side panel or cover are compromised,
remove the product from use.
• Always make sure that the product reaches room temperature before you setup or operate the product.
• Before first use, disinfect the internal water circuit.
• Do not use Altrix located near or stacked with other medical equipment. If it is necessary to locate Altrix near other
medical equipment, make sure it operates as intended.
• Always apply the wheel locks to prevent unintended movement.
• Always use Stryker accessories. Only IEC 60601-1 equipment shall be hooked to the patient temperature ports.
Failure to comply with these instructions may invalidate any or all warranties and may negatively affect the products
EMC performance. This also protects the product from cardiac defibrillation.
• Avoid the use of materials of good thermal conductivity, such as water, gel, or similar substances, with the Altrix
system not powered on. This can decrease the temperature of the body of a patient.
• Do not apply thermal transfer devices to patients with ischemic limbs. This may result in harm to the patient.
• Do not use this product if the patient has a transdermal medication (patch) as this can result in increased drug
delivery.
• Always pre-fill the thermal transfer device with sterile distilled water before you apply it to the patient. This is to
reduce the risk of pressure ulcers.
• Electric shock. This equipment must only be connected to a supply mains with protective earth.
• Always plug this product directly into a properly grounded hospital-grade or medical-grade wall outlet to achieve
grounding reliability.
• Do not use high frequency surgical instruments or endocardial catheters while the Altrix system is in use. This is to
avoid the risk of electrical shock, burns, or electromagnetic interference.
• Explosion risk. This product is not suitable for use in the presence of flammable anesthetic mixture with air or with
oxygen or nitrous oxide other than nasal or mask type.
• Do not place cables, hoses, or power cord in walkways to avoid the risk of trip hazards.
• Avoid reduction in water flow. Do not connect two or more thermal transfer devices in a series on a single port.
www.stryker.com 8001-009-0 01 REV G 5
Summary of safety precautions
CAUTION (CONTINUED)
• Do not use three or more adult Mul-T-Blanket’s at the same time to avoid the risk of water overflow when you power
off the controller.
• When you operate the product near ambient temperature limitations of 15.0° C (59.0° F) or 32.0° C (89.6° F), you
may experience a reduction in product performance.
• Do not place your fingers in between the reservoir and the sides of the controller, to avoid the risk of pinching your
fingers.
• Always use sterile distilled water or water that has been passed through a filter less than or equal to 0.22 microns
with this product.
• Always fill the reservoir with room temperature sterile distilled water to reduce the risk of burn.
• Do not overfill the reservoir to avoid the risk of water spillage and fall.
• Always make sure that there are no water leaks before starting a defibrillation.
• When using the temperature controlled Automatic therapy mode for warming (min, med, or custom), switching to
other modes, changing the target patient temperature, or changing the therapy selection may impact the overall
benefit of therapy.
• Always monitor the patient for shivering, temperature, signs of intolerance, and skin condition when using this
product.
• Always store the power cord, cables, and hoses before you transport the product to reduce the risk of trip hazard.
• Do not store the product with water in the device.
• Always store the product within the specified environmental condition values.
• Always use extra care when you transport the product long distances and on inclines greater than five degrees. Ask
for help, if necessary, to avoid the risk of tipping.
• Always use the handle to move the product. Do not attempt to move the product by pulling on cables, hoses, or by
any other means.
• Avoid ramps that are steeper than ten degrees to avoid tipping the product.
• Do not hang items on the controller handle to avoid the risk of tipping the product.
• Do not power wash this product.
• Do not use quaternaries that contain glycol ethers as they may damage the reusable accessories.
• Do not disinfect the internal water system with a thermal transfer device attached as this may cause a leak.
• Do not use bleach or any other cleaning or disinfectant agents for internal circuits. This could result in damage to the
product. Only use approved disinfectant tablets.
• Always drain the product before disinfecting the internal water circuit. Failure to drain the product may reduce the
effectiveness of the disinfection process.
• Always remove the product from use before servicing any components. Contact qualified service personnel for
service.
Notes
• Disinfection of the Altrix internal water system was validated using M. mucogenicum.
6 8001-009-001 REV G www.stryker.com
Introduction
This manual assists you with the operation or maintenance of your Stryker product. Read this manual before operating or
maintaining this product. Set methods and procedures to educate and train your staff on the safe operation or
maintenance of this product.
CAUTION
• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in
this manual.
• Do not modify the product or any components of the product. Modifying the product can cause unpredictable
operation resulting in injury to patient or operator. Modifying the product also voids its warranty.
Notes
• This manual is a permanent part of the product and should remain with the product even if the product is sold.
• Stryker continually seeks advancements in product design and quality. This manual contains the most current
product information available at the time of printing. There may be minor discrepancies between your product and
this manual. If you have any questions, contact Stryker Customer Service or Technical Support at 1-800-327-0770.
Product description
The Stryker model 8001Altrix™ Precision Temperature Management System can supply water to an individual or multiple
thermal transfer devices simultaneously with each of these circuits monitored separately. Three operating modes are
available to ease patient care: Automatic, Manual, and Monitor. The controller uses the patient temperature probe to
provide closed loop feedback for automatic patient temperature management and monitoring. The controller alarms
visual and audible indications for when safety parameters are exceeded or it detects system function or performance
irregularities. The Altrix system is able to provide a patient temperature output reference signal to be connected to a nonspecific third party device or system.
The controller regulates water temperatures between 4.0° C (39.2° F) and 40.0° C (104.0° F) and circulates the heated or
cooled water via hose sets through the thermal transfer devices. A graphical display provides the user an interface for
selecting desired water or patient temperature settings, operating modes, help menus, and other key parameters. Visual
indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The
system’s water temperature and flow outputs can be monitored with 400 series compatible devices to optimize system
operation.
The Altrix system includes the following components:
• controller
• reusable hose sets
• thermal transfer devices (blankets, vests, and leg wraps)
• patient temperature probes
• reusable adapter cables
• reusable patient temperature output cable
Note: The blankets, vests, leg wraps, and patient temperature probes are type BF applied parts.
Indications for use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal
transfer devices for the application of regulating human body temperature in situations where a physician or clinician with
prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
• Maintain pre-set body temperature as determined by the physician
• Maintain normal body temperature during surgical procedures
www.stryker.com 8001-009-0 01 REV G 7
Introduction
Indications for use (Continued)
• For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn
units, and medical/surgical units
• Adult and pediatric patients
• Monitoring and controlling patient temperature
• Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Intended users
• Physicians
• Advanced Practice Registered Nurses
• Nurses
Expected service life
The Altrix controller has a five year expected service life under normal use, conditions, and with appropriate periodic
maintenance. See the maintenance manual for preventive maintenance and service information.
Contraindications
For core body temperature regulation:
• Raynaud’s Phenomenon (primary or secondary)
• Application to lower extremities distal to aortic cross-clamping
Specifications
Model 8001-000-001
Electrical Requirements - AC Voltage Input Current and Voltage
Ratings
Physical dimensions
Height 42.5 in. 107.9 cm
Width 15.0 in. 38.1 cm
Depth 23.0 in. 58.4 cm
Empty weight 150.0 lb 68.0 kg
Filled weight 160.5 lb 72.8 kg
Reservoir capacity 1.3 gal 5.0 L
Water temperature
Control setting range
39.2° - 104.0° F
120VAC, 60Hz 12A
4.0° - 40.0° C
Control accuracy ±0.3° C (4.0° - 40.0° C)
Display measurement accuracy
Display / resolution setting
Default setting 104.0° F 40.0° C
8 8001-009-001 REV G www.stryker.com
±0.2° C (4.0° - 40.0° C)
0.1° C
Specifications (Continued)
89.9°F
(32.2°C)
59°F
(15°C)
140 °F
(60 °C)
-40°F
(-40°C)
140 °F
(60 °C)
-20°F
(-29°C)
75 %
30 %
95 %
10 %
95 %
25 %
1060 hPa
700 hPa
1060 hPa
500 hPa
Patient temperature
Introduction
Control setting range
89.6° - 100.4° F
32.0° - 38.0° C
Control accuracy ±0.1° C (32° - 38° C)
Measurement accuracy
±0.3° C (25.0° - 45.0° C)
±0.4° C (0.0° C - 24.9° C, 45.1° C - 50.0° C)
Display / resolution setting
Display range 32.0° - 122.0° F
Default setting
0.1° C
98.6° F
0.0° - 50.0° C
37.0° C
Controller
Heater capacity, maximum 500 watts
Circulating fluid Sterile distilled water or water that has been passed through a filter less than or
equal to 0.22 microns with this product
Battery 9V Lithium
Alarm tone range
Water flow rate in each hose port
Refrigerant type
Power cord length
Clinical thermometer
75 - 85 dBA per standard IEC 60601-1-8
Typical 1.2 lpm
R134a
14 to 15 feet
Direct mode
4.2 - 4.5 meters
Equipment Class Class I
Rated for continuous operation
Note: The controller takes approximately 9 minutes to heat from 23.0±2° C (73.4° F) to 37.0° C (98.6° F) when not
connected to a patient. Time will vary when connected to a patient.
Stryker reserves the right to change specifications without notice.
For more information about thermal transfer devices, cables, or probes, see the manufacturer’s instructions for use.
Environmental
conditions
Operation Storage Transporta tion
Ambient temperature
Relative humidity (noncondensing)
Atmospheric pressure
www.stryker.com 8001-009-0 01 REV G 9
Not applicable
Product illustration
B
C
D
E
F
G
H
I
K
J
L
M
Introduction
Figure 1: Controller, patient front
Figure 2: Controller, patient back
A Storage compartment G Graphical user interface display
B Removable water reservoir H Handle
Front wheels I Power cord
C
D Patient probe ports J Hose and power cord management straps
E Patient temperature output port K
F Hose connection ports L Wheel locks
Swivel casters
M
Ground chain
10 8001-009-0 01 REV G www.stryker.com
Product system
Introduction
Figure 3: Altrix system - controller with thermal transfer devices
Figure 4: Closed loop system
1
Human machine interface (HMI) system
2 Physical boundary
3 Patient system 8
6
Controls
7
Flow system
Energy transfer system
4
Patient temperature port 9
5
Fluid delivery system 10
www.stryker.com 8001-009-0 01 REV G 11
Water flow
Signals
Introduction
Product functions
The graphical user interface shown is for reference only. The image shows where you will see the icons and buttons
illuminate when they are active. At no time will you see all of these icons at the same time.
Buttons
The buttons are located on the outside of the graphical user interface. They are visible when available.
Icon Name Function
Stand-by Press and hold the button for two seconds to stop therapy or
power off
Therapy paused
View temperature
Lock / unlock screen
Audio paused Pause or resume the audible indicator when an alarm is active.
Automatic therapy mode
Press and hold the button for two seconds to pause or resume
therapy
Select temperature degree in Celsius or Fahrenheit
Press and hold the button for two seconds to lock or unlock the
graphical user interface
Silences each alarm for five or ten minutes depending on the
alarm condition. This button breathes¹ to indicate that it is in a
paused state.
Cools or warms the patient to a selected patient target
temperature
Manual therapy mode
Monitor only mode Displays the current patient temperature (no therapy)
12 8001-009-0 01 REV G www.stryker.com
Cools or warms the water to a selected water target temperature
Introduction
Product functions (Continued)
Icon Name Function
Increase
Increases the water or patient temperature by 0.1° for cooling or
warming temperature
Note: Press and hold the increase button to move the
temperature up faster.
Decrease
Back Returns to the previous screen or cancel an operation
Edit settings, Exit, or Cancel
Confirm selection
Next or More Changes to the next screen, option, or setting
Page indicators (may also
appear vertical)
Settings Displays the summary of the current, visual / audible, language,
Graph Graphical display of the selected items such as patient
Help
Decreases the water or patient temperature by 0.1° for cooling or
warming temperature
Note: Press and hold the decrease button to move the
temperature down faster.
Edit current settings, exit, or cancel
Accepts the selected settings
Indicates that there is more than one page associated with the
screen topic for the page that is currently displayed
or primary probe settings
temperature, target temperature, water temperature, and power
level
Displays contextual help screens for therapies, navigation,
buttons, and alarm screens. This button breathes to allow the
user to view the alarm screen.
Note: If not specified above, make sure that you tap and release the buttons or icons for you selection to register with the
system.
Note: The Light sensor (non selectable)
Note: ¹Breathe: The brightness of the button or icon will go to a low light and then increase to a bright light. This cycle
repeats.
, dims or brightens the LCD based on the amount of light in the room.
Visual indicators
When the visual indicators are solid green, this indicates that the function is stabilized. The visual indicators breathe to
indicate that the controller is at the intermediate target.
www.stryker.com 8001-009-0 01 REV G 13
Product functions (Continued)
3
2
1
1
2
|
|
Icon, green Name
Water temperature on target, solid green when active, does not breathe
Patient temperature on target
Patient probe A port, stabilized
Patient probe B port, stabilized
External device, patient probe A
External device, patient probe B
Introduction
Stand-by
Water flow detected, ports 1, 2, or 3 are active, solid green when active, does not breathe
Graphical user interface icons
Icon Name
Cooling therapy
Warming therapy
Current therapy duration
Total duration
14 8001-009-0 01 REV G www.stryker.com
Visual and audible tests
Target patient or water temperature
Product functions (Continued)
Med
Max
Min
Set Custom
Max
Med
Min
Icon Name
Medium: patient temperature increases at a rate of 4.0° C in 12 hours (0.33° C/ hour).
Maximum: water temperature approaches water target as fast as possible
Minimum: patient temperature increases at a rate of 4.0° C in 24 hours (0.17° C/hour).
Set Custom: patient temperature increases at a customized temperature and time period the
operator selects. The temperature increases 0.05° C/hour to 0.5° C/hour
Maximum: water temperature approaches water target as fast as possible
Medium: water is cooled to target, with a max of 15.0° C difference between the patient and
the water temperature
Minimum: water is cooled to target, with a max of 10.0° C difference between the patient and
the water temperature
Introduction
Product alarms
Audible alarms work in conjunction with the display.
Alarm priority and description
Priority alarm Audible reminder Icon flashes
Medium
Low
Audio pause Button breathes as a reminder
Note: You can pause the audio alarm. The alarm will resume within five to ten minutes or sooner, if not resolved. The
alarm will resume depending on when the alarms became active and the number of active alarms.
Repetitive burst of three beeps every 25
seconds
Single burst of two beeps The icon does not flash when there is a low
When a medium priority alarms, the icon will
flash to indicate there is an alarm. It will
continue to flash until the alarm is resolved.
priority alarm.
Pausing the alarm will not stop the icon from
flashing.
www.stryker.com 8001-009-0 01 REV G 15
Product alarms (Continued)
Introduction
Icon, yellow Name Alarm priority
and delay
Water
temperature
deviation
No water Medium, 20
No water flow
Check water flow
on any port
Medium Water
second delay
Medium, 20
second delay
Medium, 60
second delay
Message Therapy
interrupted
No Temporary
temperature is
±0.8° C (1.4° F)
outside of target
temperature
No water Yes
No flow detected
Reduced flow
detected
Yes
No
Check
condition upon
startup, addition
of thermal
transfer device,
or addition of
water
Check for leaks
Add a minimum
of 2 liters of
water
Check for leaks
and obstructions
at connections,
hoses, and
thermal transfer
devices
Tap Confirm, if
the water port
was removed
intentionally
Check for leaks
and obstructions
at connections,
hoses, and
thermal transfer
devices
16 8001-009-0 01 REV G www.stryker.com
Loading...