Stryker altrix Operation Manual
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Stryker altrix Operation Manual

Precision temperature management system
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Altrix™ Precision Temperature Management System
8001
Operations Manual
2016/12 G.1
8001-009-001 REV G
www.stryker.com

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  • Page 1 Altrix™ Precision Temperature Management System 8001 Operations Manual 2016/12 G.1 8001-009-001 REV G www.stryker.com...
  • Page 2 sample text...
  • Page 3 Consult instructions for use General warning Caution Warning; electricity Catalogue number / model 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.
  • Page 4 NO 80601-2-56: 12, IEC 60601-1-8:2007, CAN/CSA C22.2 NO 60601-1-8-08, IEC 60601-1- 87VL Medical 10:2008, CAN/CSA C22.2 NO 60601-1-1 0-09, IEC 60601-1-6, CAN/CSA-C22.2 No. 60601-1- Electrical Equipment 6:11 Liquid level indicator Fragile, handle with care Keep dry Do not stack This way up 8001-009-001 REV G www.stryker.com...

  • Page 5: Table Of Contents

    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 8001-009-001 REV G...
  • Page 6 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 8001-009-001 REV G www.stryker.com...
  • Page 7 Table of Contents To obtain parts and service........................59 Return authorization........................... 59 Damaged product ..........................59 International warranty clause ....................... 59 www.stryker.com 8001-009-001 REV G...

  • Page 8: Warning/Caution/Note Definition

    Note: Provides special information to make maintenance easier or important instructions clearer. 8001-009-001 REV G www.stryker.com...

  • Page 9: Summary Of Safety Precautions

    • 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. •...
  • Page 10 • 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. 8001-009-001 REV G www.stryker.com...

  • Page 11: Introduction

    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.

  • Page 12: Intended Users

    • 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: •...
  • Page 13 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.

  • Page 14: Product Illustration

    Storage compartment Graphical user interface display Removable water reservoir Handle Front wheels Power cord Patient probe ports Hose and power cord management straps Patient temperature output port Swivel casters Hose connection ports Wheel locks Ground chain 8001-009-001 REV G www.stryker.com...

  • Page 15: Product System

    Introduction Product system Figure 3: Altrix system - controller with thermal transfer devices Figure 4: Closed loop system Human machine interface (HMI) system Controls Physical boundary Flow system Patient system Energy transfer system Patient temperature port Water flow Fluid delivery system Signals www.stryker.com...

  • Page 16: Product Functions

    Automatic therapy mode Cools or warms the patient to a selected patient target temperature Manual therapy mode Cools or warms the water to a selected water target temperature Monitor only mode Displays the current patient temperature (no therapy) 8001-009-001 REV G www.stryker.com...

  • Page 17: Visual Indicators

    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. 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 8001-009-001 REV G...

  • Page 18: Graphical User Interface Icons

    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 Visual and audible tests Target patient or water temperature 8001-009-001 REV G www.stryker.com...

  • Page 19: Product Alarms

    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. www.stryker.com 8001-009-001 REV G...
  • Page 20 Check water flow Medium, 60 Reduced flow Tap Confirm, if on any port second delay detected the water port was removed intentionally Check for leaks and obstructions at connections, hoses, and thermal transfer devices 8001-009-001 REV G www.stryker.com...
  • Page 21 Patient Patient Check output temperature temperature adapter cable output (A or B) output is connection. Tap inaccurate on the Confirm to external device, reactivate the or outside output port. supported range www.stryker.com 8001-009-001 REV G...

  • Page 22: Contact Information

    Portage, MI 49002 To view your operations or maintenance manual online, see https://techweb.stryker.com/. Have the serial number (A) of your Stryker product available when calling Stryker Customer Service or Technical Support. Include the serial number in all written communication. Serial number location Date of manufacture The year of manufacture is the first four digits of the serial number.

  • Page 23: Setup

    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.
  • Page 24 The system runs through visual tests of the Green Indicators, Yellow Indicators, White Indicators, and Fluid Controller Light tests, and audible alarms. • The test will continue until you stop it. To stop the Visual / Audible test, tap the Back button. To exit settings, tap the Exit button. 8001-009-001 REV G www.stryker.com...

  • Page 25: Operation

    When placing the product, do not block access to the hospital-grade plug or medical-grade wall outlet. CAUTION 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.

  • Page 26: Selecting And Connecting A Temperature Probe

    Selecting and connecting a temperature probe CAUTION • 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. • Always use Stryker accessories. Only IEC 60601-1 equipment shall be hooked to the patient temperature ports.

  • Page 27: Connecting The Insulated Hoses

    Connect the other end of the reusable patient temperature output cable to the external device. Note: When Altrix is powered, the calibration of the patient temperature output is completed. Note: If you need to calibrate the patient temperature output cable, power cycle the product by removing the plug from the wall.

  • Page 28: Disconnecting The Insulated Hoses

    CAUTION • 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. •...

  • Page 29: Powering On The Product

    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 Altrix system from service to avoid the risk of serious injury or death. Contact the appropriate maintenance personnel.

  • Page 30: Removing And Replacing The Reservoir

    Push the reservoir back into place. Make sure that the reservoir is secure to avoid water leakage. Filling the reservoir with sterile distilled water The removable reservoir is translucent for you to see the water levels. 8001-009-001 REV G www.stryker.com...

  • Page 31: Selecting And Setting The Primary Probe

    If the probe is not stabilized within three minutes, the message “Probe stabilization error” will appear. Tap the Help button for more detail. • You can select help at any time to display help with the current screen or icon descriptions. www.stryker.com 8001-009-001 REV G...

  • Page 32: Filling A Thermal Transfer Device

    • Monitor non-therapy For mode descriptions, tap the Help button. WARNING Always check the integrity of the patients skin and temperature according to hospital protocol when using the Altrix system. CAUTION • 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.

  • Page 33: Starting Automatic Therapy Mode

    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 Tap Confirm. Tap the Edit button to make changes. www.stryker.com 8001-009-001 REV G...

  • Page 34: Setting Or Editing The Warming Rates

    Tap Manual mode. The default water target temperature is 40.0° C (104.0° F) upon initial entry. Tap Confirm. To select the desired water temperature, tap the Increase or Decrease buttons or hold the button to go faster. To edit water temperature, tap the Edit button. Tap Confirm. 8001-009-001 REV G www.stryker.com...

  • Page 35: Starting Monitor Mode

    Displaying the data storage The system gathers data at five second intervals and is limited to 90 minutes of storage. The graphical display defaults to show data for all four variables in the Manual and Automatic modes. www.stryker.com 8001-009-001 REV G...

  • Page 36: Opening And Securing Items In The Storage Compartment

    To open the storage compartment door, lift up on the door (Figure 19 on page 33). The storage compartment secures the following items: • Two patient probes • Two reusable adapter cables • One reusable patient temperature output cable • Product operations manual 8001-009-001 REV G www.stryker.com...

  • Page 37: Stopping Therapy Or Powering Off The Product

    Discard the disposable thermal transfer devices based on your local waste management protocol, if applicable. Draining water from the reservoir To drain the water from the reservoir: Removing and replacing the reservoir on page Dispose of the water per hospital protocol. www.stryker.com 8001-009-001 REV G...

  • Page 38: Draining Water From The Controller And Hoses

    Raise all the hoses completely above the connection ports on the controller. Allow the product to drain for a minimum of two minutes. Push down on the drain plug to close the drain. Replace the reservoir. 8001-009-001 REV G www.stryker.com...

  • Page 39: Storing The Power Cord And Hoses

    Cleaning the external surfaces on page Disinfecting external surfaces on page Notes • Always bring the controller to room temperature after high or low temperature storage. • Always store the controller with the reservoir in place. www.stryker.com 8001-009-001 REV G...

  • Page 40: Transporting The Product

    Use two or more operators to move the system on inclines or long distances. Notes • Wheel chair ramps are usually less than five degrees. • The system weighs 150 lb (68.0 kg) when dry. Weight also depends on other items in the storage compartment. 8001-009-001 REV G www.stryker.com...

  • Page 41: Cleaning

    13. Wipe the controller, reservoir and reservoir lid surfaces, and system components with a clean, dry cloth to remove any excess liquid. 14. Replace the reservoir. 15. Allow the external surfaces of the controller and components to dry thoroughly. www.stryker.com 8001-009-001 REV G...

  • Page 42: Disinfecting

    Reapply disinfectant to the cloth as needed. Also wipe the following system components: • Hose connectors • Power cord • Hose and power cord management straps • Storage compartment door • Inside storage compartment 8001-009-001 REV G www.stryker.com...

  • Page 43: Disinfect The Internal Water Circuit And Hoses Every 14 Days

    • Always drain the product before disinfecting the internal water circuit. Failure to drain the product may reduce the effectiveness of the disinfection process. Note: Disinfection of the Altrix internal water system was validated using M. mucogenicum. Tools Required: •...
  • Page 44 Figure 26: Colder style connector hose connected to a tool adapter hose If you have Clik-Tite hoses, make sure that the connector ends are connected and closed (A), and clamps are open (B). Complete this for all three hoses. Figure 27 on page 41 8001-009-001 REV G www.stryker.com...

  • Page 45: Disinfecting The Internal Water Circuit And Hoses

    Using appropriate measuring equipment, fill the empty reservoir with 1 gallon (3.8 L) of sterile-distilled water. Note: Always allow the disinfectant tablets to completely dissolve before starting the 20 minute disinfection cycle. Place the reservoir into the controller. www.stryker.com 8001-009-001 REV G...
  • Page 46 17. Remove the reservoir. Pull forward at an angle, and lift out the reservoir. 18. Remove the bottom hose end from the hydraulic connector adapter in the reservoir lid by pushing down on the collar. 19. Empty water from the reservoir, dispose of the water per hospital protocol. 8001-009-001 REV G www.stryker.com...

  • Page 47: Rinsing The Internal Water Circuit And Hoses

    Connect the bottom hose end to the hydraulic connector in the lid of the reservoir. Figure 32: Bottom hose end in the lid of the reservoir Plug the power cord into a wall outlet. Press and hold the Stand-by button. Tap the Manual mode icon. www.stryker.com 8001-009-001 REV G...
  • Page 48 22. Place the reservoir into the controller. 23. Disconnect and store the service tool adapter hoses from all three of the hoses. (If applicable, when used with colder style hoses.) 24. Store the power cord, cables, and hoses. 8001-009-001 REV G www.stryker.com...

  • Page 49: Accessories

    Accessories Thermal transfer devices These accessories are currently available for purchase. Not all accessories are available for all regions. Call Stryker Customer Service at 1-800-327-0770 for availability and pricing. For more information, see the thermal transfer device instructions for use.

  • Page 50: Patient Temperature Probes

    16FR Foley catheter temperature 8001-063 -416 4466 sensing probe Cables Description Part Number Reusable adapter cable 8001-064-110 Reusable patient temperature output cable 8001-064-120 Hoses Description Part Number Insulated Clik-Tite Hose 8001-064-035 8001-064-135 Insulated Colder Connector Hose 8001-009-001 REV G www.stryker.com...

  • Page 51: Troubleshooting

    Quick disconnect not Secure the thermal transfer Not applicable seated properly device connection to the controller Replace the cable or thermal transfer device Water level alarm Water level too low Fill reservoir Not applicable www.stryker.com 8001-009-001 REV G...
  • Page 52 25° - 45°C). • Find the “Temperature Output Alarm” screen • Tap Confirm to restart calibration • Wait until the “Monitor” is solid • Connect the external device to the reusable adapter cable 8001-009-001 REV G www.stryker.com...

  • Page 53: Preventive Maintenance

    Preventive maintenance At a minimum, make sure that all items listed during annual preventive maintenance for all Stryker Medical products. Preventive maintenance is to be completed by a qualified service technician. Inspect all of the following items: Power cord and plug for fraying...

  • Page 54: Cleaning Tools

    Cleaning tools Description Part Number BruClean TbC 13.1g tablet, 52 count 8001-999-224 Service tool adapter hose 8001-999-017 8001-009-001 REV G www.stryker.com...

  • Page 55: Alarm Conditions

    The product only activates the Check Patient Probe Alarm when met during an Active Therapy. Otherwise, the alarm is disabled. Alarm generation: Primary patient temperature changes by more than 1.0° C within two minutes. Note: The product will deactivate the heat exchange and keep the pump activated as requested by the Active Therapy. www.stryker.com 8001-009-001 REV G...

  • Page 56: Patient Probe Malfunction Alarm

    This alarm notifies the operator that the water is not responding as expected to the therapy. The product is at full power, with the current mode and the temperature selection. The water temperature cannot remain within a range of ±0.8º C of the selected Water Target Temperature. 8001-009-001 REV G www.stryker.com...

  • Page 57: Check Water Flow Alarm

    This alarm converts a therapy pause into an alarm if the duration of the pause is too long. Alarm generation: When paused for five minutes, the product will display the Therapy Paused Time Out Alarm. After you resume the current therapy, the Therapy Paused Time Out Alarm is deactivated. www.stryker.com 8001-009-001 REV G...

  • Page 58: Remove From Use Mode

    Refrigerant control valve fault • Main DC power lost • CAN heart beat lost • Dual safety temperature sensors do not match readings • Dual safety temperature sensors are out of the allowed range • Hardware watchdog heartbeat failure 8001-009-001 REV G www.stryker.com...

  • Page 59: Emc Information

    EMC Information Guidance and manufacturer’s declaration - electromagnetic emissions The Altrix system is intended for use in the electromagnetic environment specified below. The customer or the user of Altrix should assure that it is used in such an environment. Compliance...
  • Page 60 EMC Information Guidance and manufacturer’s declaration - electromagnetic immunity The Altrix system is suitable for use in the electromagnetic environment specified below. The customer or the user of Altrix should assure that it is used in such an environment. Electromagnetic...
  • Page 61 EMC Information (Continued) Guidance and manufacturer’s declaration - electromagnetic immunity Portable and mobile RF communications equipment should be used no closer to any part of the Altrix system, including cables, than the recommended Conducted RF 3 Vrms separation distance 3 Vrms...
  • Page 62 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Altrix system is used exceeds the applicable RF compliance level above, the Altrix system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Altrix system.

  • Page 63: Warranty

    Stryker Medical temperature management products have a five year expected service life under normal use, conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. The above noted warranty periods apply only to the original purchaser of the Altrix and begin on the date of delivery to such original purchaser.
  • Page 66 Stryker Medical 3800 E. Centre Avenue Portage, MI 49002 2016/12 www.stryker.com 8001-009 -001 REV G...

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