Stryker Altrix 8001 User manual

0086
2016/08 D.2 8001-009-005 REV D www.stryker.com
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Operations Manual
Altrix™ Precision Temperature Management System
8001

sample text

www.stryker.com 8001-009-005 REV D
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EENN
Symbols
Refer to instruction manual/booklet
General mandatory action sign
Consult instructions for use
General warning
Caution
Warning; electricity
Catalogue number / model

Serial number
      
or 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
IP 1 Protection from dripping water from above the device
Defibrillation proof type B applied part
ONLY
CAUTION
ederal law (USA) restricts this device to sale by or on the order of a physician.

8001-009-005 REV D www.stryker.com
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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.
Please recycle waste batteries
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.
87VL Medical
Electrical Equipment
Medical Equipment Classified by Underwriters Laboratories Inc. with Respect to Electric Shock,
ire, 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 60601-1-
10:2008, CAN/CSA C22.2 NO 60601-1-1 0-09, IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1-
6:11
Liquid level indicator
0086
CE Mark
European authorized representative
ragile, handle with care
Keep dry
Do not stack
This way up
Export only

0086
2016/08 D.2 8001-009-005 REV D www.stryker.com
Altrix™ Precision Temperature Management System
8001
Operations Manual

sample text

www.stryker.com 8001-009-005 REV D
EEnngglliisshh
EENN
Symbols
Refer to instruction manual/booklet
General mandatory action sign
Consult instructions for use
General warning
Caution
Warning; electricity
Catalogue number / model

Serial number
      
or 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
IP 1 Protection from dripping water from above the device
Defibrillation proof type B applied part
ONLY
CAUTION
ederal law (USA) restricts this device to sale by or on the order of a physician.

8001-009-005 REV D www.stryker.com
EEnngglliisshh
EENN
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.
Please recycle waste batteries
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.
87VL Medical
Electrical Equipment
Medical Equipment Classified by Underwriters Laboratories Inc. with Respect to Electric Shock,
ire, 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 60601-1-
10:2008, CAN/CSA C22.2 NO 60601-1-1 0-09, IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1-
6:11
Liquid level indicator
0086
CE Mark
European authorized representative
ragile, handle with care
Keep dry
Do not stack
This way up
Export only

www.stryker.com 8001-009-005 REV D 1-1
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Table of Contents
Warning/Caution/Note Definition................................................................................................................1-4
Summary of safety precautions .................................................................................................................1-5
Introduction...........................................................................................................................................1-7
Product description...........................................................................................................................1-7
Intended use ...................................................................................................................................1-7
Intended users.................................................................................................................................1-8
Expected service life.........................................................................................................................1-8
Contraindications..............................................................................................................................1-8
Specifications..................................................................................................................................1-9
Product illustration.......................................................................................................................... 1-11
Product system.............................................................................................................................. 1-12
Product functions ........................................................................................................................... 1-13
Buttons .................................................................................................................................. 1-13
Visual indicators....................................................................................................................... 1-14
Graphical user interface icons..................................................................................................... 1-15
Product alarms .............................................................................................................................. 1-16
Alarm priority and description...................................................................................................... 1-16
Contact information......................................................................................................................... 1-19
Serial number location..................................................................................................................... 1-19
Date of manufacture ....................................................................................................................... 1-19
Setup................................................................................................................................................. 1-20
Inspecting..................................................................................................................................... 1-20
Selecting a language....................................................................................................................... 1-20
Testing visual and audible alarms ...................................................................................................... 1-20
Operation ........................................................................................................................................... 1-22
Placing the product......................................................................................................................... 1-22
Applying or releasing the wheel locks.................................................................................................. 1-22
Selecting and connecting a temperature probe ..................................................................................... 1-23
Connecting the reusable patient temperature output cable ...................................................................... 1-23
Connecting the insulated hoses......................................................................................................... 1-24
Disconnecting the insulated hoses ..................................................................................................... 1-25
Connecting and disconnecting thermal transfer devices.......................................................................... 1-25
Powering on the product .................................................................................................................. 1-26
Removing and replacing the reservoir ................................................................................................. 1-27
illing the reservoir with sterile distilled water........................................................................................ 1-27
Selecting and setting the primary probe............................................................................................... 1-28
illing a thermal transfer device......................................................................................................... 1-29
Selecting a therapy mode................................................................................................................. 1-29
Starting Automatic therapy mode ....................................................................................................... 1-30
Setting or editing the warming rates.................................................................................................... 1-30
Setting or editing the cooling rates...................................................................................................... 1-31
Starting Manual mode ..................................................................................................................... 1-31
Starting Monitor mode ..................................................................................................................... 1-32

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Table of Contents
Switching modes............................................................................................................................ 1-32
Pausing and resuming therapy .......................................................................................................... 1-32
Displaying the data storage............................................................................................................... 1-32
Opening and securing items in the storage compartment ........................................................................ 1-33
Stopping therapy or powering off the product........................................................................................ 1-34
Draining the thermal transfer devices.................................................................................................. 1-34
Draining water from the reservoir ....................................................................................................... 1-34
Draining water from the controller and hoses........................................................................................ 1-35
Storing the power cord and hoses...................................................................................................... 1-36
Storing the controller....................................................................................................................... 1-36
Transporting the product.................................................................................................................. 1-37
Cleaning............................................................................................................................................. 1-38
Cleaning the external surfaces.......................................................................................................... 1-38
Disinfecting......................................................................................................................................... 1-39
Disinfecting external surfaces ........................................................................................................... 1-39
Disinfect the internal water circuit and hoses every 14 days..................................................................... 1-40
Draining the internal water circuit and hoses for disinfection .................................................................... 1-40
Disinfecting the internal water circuit and hoses .................................................................................... 1-42
Rinsing the internal water circuit and hoses.......................................................................................... 1-44
Accessories ........................................................................................................................................ 1-46
Thermal transfer devices ................................................................................................................. 1-46
Thermal transfer device kits.............................................................................................................. 1-46
Patient temperature probes .............................................................................................................. 1-47
Cables ......................................................................................................................................... 1-47
Hoses .......................................................................................................................................... 1-47
Troubleshooting ................................................................................................................................... 1-48
Preventive maintenance......................................................................................................................... 1-50
Cleaning tools................................................................................................................................ 1-50
Alarm conditions................................................................................................................................... 1-51
Check patient probe alarm ............................................................................................................... 1-51
Patient probe malfunction alarm ........................................................................................................ 1-52
Patient probe disconnect alarm ......................................................................................................... 1-52
Patient temperature deviation medium alarm ........................................................................................ 1-52
Patient temperature output deviation alarm .......................................................................................... 1-52
Normothermia deviation alarm........................................................................................................... 1-52
Water temperature deviation alarm group ............................................................................................ 1-52
Check water flow alarm ................................................................................................................... 1-53
Power backup level alarm ................................................................................................................ 1-53
Therapy paused time out alarm ......................................................................................................... 1-53
Remove from use mode................................................................................................................... 1-54
EMC Information .................................................................................................................................. 1-55
Warranty ............................................................................................................................................ 1-59
Warranty exclusion and damage limitations.......................................................................................... 1-59

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Table of Contents
To obtain parts and service............................................................................................................... 1-59
Return authorization........................................................................................................................ 1-59
Damaged product........................................................................................................................... 1-59
International warranty clause ............................................................................................................ 1-59

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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.

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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.
ollow 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 R 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.
ailure 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.

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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° ) or 32.0° C (89.6° ), 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. ailure 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.

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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 non-
specific third party device or system.
The controller regulates water temperatures between 4.0° C (39.2° ) and 40.0° C (104.0° ) 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 B applied parts.
Intended 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

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Introduction
Intended use (Continued)
• or 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
• Mild therapeutic hypothermia for post cardiac arrest
• Mild therapeutic hypothermia Neonatal hypoxic ischemic encephalopathy (HIE)
• Mild therapeutic hypothermia post traumatic brain injury (TBI)
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
or core body temperature regulation:
• Raynaud’s Phenomenon (primary or secondary)
• Application to lower extremities distal to aortic cross-clamping
or inducing mild hypothermia
Absolute
• Hemorrhagic stroke
• Cardiac arrest due to trauma
• Glasgow Coma Scale (GCS) >=eight
• Cardiac arrest due to drug overdose
• Pre-existing hypothermia (<34.0° C; 93.2° )
• Uncontrolled active bleeding
• Uncontrolled hemodynamically unstable arrhythmias
Relative
• Thrombocytopenia (platelet count <50x109/L) or baseline coagulopathy
• Severe refractory hypotension (mean arterial pressure <60mmHg) not corrected by fluid infusion, vasopressors or
invasive hemodynamic support
• Prolonged cardiac arrest (>60 minutes)
• Pregnancy
• Terminal condition
• Valid Do Not Resuscitate (DNR) directives
• ROSC greater than six hours

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Introduction
Contraindications (Continued)
• Severe arrhythmia
• Advanced malignancy
Specifications
Model 8001-000-002 8001-000-003,
8001-000-006
8001-000-008,
8001-000-009,
8001-000-011
8001-000-013,
8001-000-015,
8001-000-016,
8001-000-017,
8001-000-018,
8001-000-019,
8001-000-021,
8001-000-022,
8001-000-023
Electrical Requirements -
AC Voltage Input Current
and Voltage Ratings
100VAC, 50/60Hz
12A
120V, 60Hz 12A 220V, 60Hz 6A 220-240V, 50Hz 6A
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
illed weight 160.5 lb 72.8 kg
Reservoir capacity 1.3 gal 5.0 L
Water temperature
Control setting range 39.2° - 104.0° 4.0° - 40° C
Control accuracy ±0.3° C (4.0° - 40.0° C)
Display measurement accuracy ±0.2° C (4.0° - 40.0° C)
Display / resolution setting 0.1° C
Default setting 104.0° 40.0° C
Patient temperature
Control setting range 89.6° - 100.4° 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° C - 24.9° C, 45.1° C - 50° C)
Display / resolution setting 0.1° C
Display range 32.0° - 122° 0.0° - 50° C
Default setting 98.6° 37.0° C

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Introduction
Specifications (Continued)
Controller
Heater capacity, maximum 500 watts
Circulating fluid Sterile distilled water
Battery 9V Lithium
Alarm tone range 75 - 85 dBA per standard IEC 60601-1-8
Water flow rate in each hose port Typical 1.2 lpm
Refrigerant type R134a
Power cord length 14 to 15 feet 4.2 - 4.5 meters
Clinical thermometer Direct mode
Equipment Class Class I
Rate for continuous operation
Note: The controller takes approximately 9 minutes to heat from 23.0±2° C (73.4° ) to 37.0° C (98.6° ) when not
connected to a patient. Time will vary when connected to a patient.
Stryker reserves the right to change specifications without notice.
or more information about thermal transfer devices, cables, or probes, see the manufacturer’s instructions for use.
Environmental
conditions Operation Storage Transporta tion
Ambient temperature
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)
Relative humidity (non-
condensing)
75 %
30 %
95 %
10 %
95 %
25 %
Atmospheric pressure
1060 hPa
700 hPa
1060 hPa
500 hPa
Not applicable

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Introduction
Product illustration
A
B
C
D
E
F
Figure 1-1: Controller, patient front
G
H
I
K
J
L
M
Figure 1-2: Controller, patient back
A Storage compartment G Graphical user interface display
B Removable water reservoir H Handle
Cront wheels I Power cord
D Patient probe ports J Hose and power cord management straps
E Patient temperature output port K Swivel casters
Hose connection ports L Wheel locks
MGround chain

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Introduction
Product system
Figure 1-3: Altrix system - controller with thermal transfer devices
Figure 1-4: Closed loop system
1Human machine interface (HMI) system 6Controls
2 Physical boundary 7low system
3 Patient system 8 Energy transfer system
4Patient temperature port 9 Water flow
5luid delivery system 10 Signals