Stryker altrix Operation Manual

Download

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

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.

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

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

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

Human machine interface (HMI) system

2 Physical boundary

3 Patient system 8

Controls

Flow system

Energy transfer system

Patient temperature port 9

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)

       





|

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

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

Product alarms (Continued)

Introduction

Icon, yellow Name Alarm priority

and delay

Check patient probe (A or B)

Probe or adapter malfunction (A or B)

Adapter cable disconnected (A or B)

Patient temperature deviation

Medium Abnormal change

Medium, 30 second delay

Medium Patient

Message Therapy

interrupted

Yes in patient temperature

No temperature signal detected.

Adapter cable not detected

temperature is ±

0.5° C (0.9° F) outside of target temperature

(Only will appear

after the initial target is reached.)

Yes

Yes Reinsert the

No Check patient

Check

Check probe condition, location, and connections

Check probe or adapter cable condition, location, and connections

adapter cable. If damaged, replace the adapter cable

condition, placement of thermal transfer devices, and all connections

Normothermia deviation

Therapy pause Medium Therapy is

Battery low Low Battery is low No Maintenance is

Patient temperature output (A or B)

Low Patient

temperature is outside of 36.0° C

(96.8° F) to 38.0°

C (100.4° F)

currently paused

Low Patient

temperature output is inaccurate on the external device, or outside supported range

Yes To resume, press

Check patient condition, placement of thermal transfer devices, and all connections

and hold the play / pause for 2 seconds

recommended. If battery is not replaced, the product may not function on the next startup.

Check output adapter cable connection. Tap Confirm to reactivate the output port.

www.stryker.com 8001-009-0 01 REV G 17

Product alarms (Continued)

Introduction

Icon, yellow Name Alarm priority

and delay

Remove from use

(RFU)

Power loss Medium Not applicable Yes

Notes

• If any of the alarm conditions persist, call maintenance.

• If page indicators appear on the alarm screen, there are multiple active alarms. The highest alarm is displayed. Tap Next or Back to view the active alarms.

Medium The system has

Message Therapy

interrupted

Yes Remove the powered off due to a malfunction

Check

product from use immediately. Notify the appropriate personnel.

Check power cord connection

Contact information

Contact Stryker Customer Service or Technical Support at: 1-800-327-0770. Stryker Medical

3800 E. Centre Avenue Portage, MI 49002 USA

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.

18 8001-009-0 01 REV G www.stryker.com

Setup

Unpack the cartons and check all items. Make sure that the product is free from visual damage before putting into service.

CAUTION

• 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.

Inspecting

Before you place the product into service, make sure that the controller works.

1. Visually inspect the product for any signs of shipping damage.

2. Plug the product into a properly grounded, hospital grade wall receptacle. Make sure that the power indicator illuminates on the operator control panel.

3. Before first use, .Disinfect the internal water circuit and hoses every 14 days on page 39

Selecting a language

The Altrix controller has several language choices. English is the default language.

To select a language when in standby mode:

1. Tap the Settings button, to show the Select Language screen. a. Tap Next, if you are in therapy mode.

2. Tap More to view other languages.

3. Select a language. Tap on the Increase or Decrease buttons or tap the language, to highlight a language of your choice.

4. Tap Confirm.

Note: If you do not touch the screen for three minutes, the LCD will return to the previous menu.

Testing visual and audible alarms

Before placing the product into service, make sure that the visual and audible alarms are functioning.

1. Tap the Settings button.

2. Tap the Back button.

3. Tap the Visual/Audible icon.

www.stryker.com 8001-009-0 01 REV G 19

Setup

Testing visual and audible alarms (Continued)

4. Tap Confirm.

Notes

• 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.

5. To stop the Visual / Audible test, tap the Back button.

6. To exit settings, tap the Exit button.

20 8001-009-0 01 REV G www.stryker.com

Operation

Placing the product

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.

Place the Altrix controller outside of the patient environment by 1.5 m (4.9 ft) (Figure 5 on page 21).

Figure 5: Product placement

Applying or releasing the wheel locks

The wheel locks are to help keep the product in place. The wheel lock prevents the rear caster wheels from rotating but does not prevent the product from sliding on the floor surface.

CAUTION

Always apply the wheel locks to prevent unintended movement.

To apply the wheel locks, push down (A) (Figure 6 on page 21) with your foot.

To release the wheel locks, pull up (A) (Figure 6 on page 21) with your foot.

Figure 6: Wheel locks

www.stryker.com 8001-009-0 01 REV G 21

Operation

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.

Use only Stryker temperature probes. See Patient temperature probes on page 46.

To connect the temperature probe:

1. Inspect the temperature probe and reusable adapter cable for wear, breakage, or fraying. Replace, if necessary.

2. Align the red dot on the Reusable Adapter Cable (B) to the controller (A) with the red dot on the patient probe port A or port B.

Figure 7: Port selected

3. Connect the plug (C) to the patient temperature probe.

4. Apply the temperature probe to the patient. Follow your hospital protocol and the manufacturer’s directions for the selected temperature probe use.

5. Tap Confirm, if applicable.

Note: Temperature readings may vary between temperature measurement sites.

Connecting the reusable patient temperature output cable

This feature allows the operator to view the temperature on the Altrix system and on an external device. Always connect the reusable patient temperature output cable to a 400 series compatible external device for temperature accuracy.

CAUTION

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.

22 8001-009-0 01 REV G www.stryker.com

Operation

Connecting the reusable patient temperature output cable (Continued)

To connect the reusable patient temperature output cable:

1. Insert the reusable patient temperature output cable into the patient temperature port (Figure 8 on page 23).

Figure 8: Patient temperature output port

2. 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. Note: For the reusable patient temperature output cable to work properly, make sure that you insert a patient

temperature probe into port A or port B.

3. Tap Confirm.

Connecting the insulated hoses

To connect the insulated hoses:

1. To connect, push back on the retaining collar of the port on the controller (Figure 9 on page 23).

Figure 9: Pull back on the retaining collar

2. Push the hose into an upper or lower port (Figure 10 on page 23) and release the collar until the retaining collar clicks into place (Figure 11 on page 23).

Note: Connect a set of ports for proper water flow.

Figure 10: Connect the hoses

Figure 11: Hoses connected

www.stryker.com 8001-009-0 01 REV G 23

Operation

Disconnecting the insulated hoses

To disconnect the insulated hoses:

1. To disconnect, push back on the retaining collar of the port on the controller.

2. Pull the hose to disconnect.

Connecting and disconnecting thermal transfer devices

Read the operations manual for the individual thermal transfer devices for warnings, cautions, and safe operating instructions before use.

CAUTION

• 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 use Stryker accessories. 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.

• Do not use three or more adult Mul-T-Blanket products at the same time to avoid the risk of water overflow when the controller is powered off.

• 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.

• Avoid reduction in water flow. Do not connect two or more thermal transfer devices in series on a single port.

• Always clamp the hoses when disconnecting the thermal transfer devices.

To connect or disconnect the Clik-Tite® connectors (Figure 12 on page 24) to the insulated hoses.

Figure 12: Clik-Tite

To connect or disconnect the Colder style (Figure 13 on page 24) to the insulated hoses.

Figure 13: Colder style connectors

To close or open hose clamps (Figure 14 on page 25).

24 8001-009-0 01 REV G www.stryker.com

Operation

Connecting and disconnecting thermal transfer devices (Continued)

Figure 14: Hose clamps

Note: The term “thermal transfer devices” is used throughout this manual and is interchangeable with blankets and

wraps, unless indicated otherwise.

Always clamp the hoses before disconnecting. See Draining the thermal transfer devices on page 33.

Powering on the product

The operator should stand in front of the controller within arm’s reach. This allows the operator to see and respond to the display notifications.

CAUTION

• 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.