Altrix Operations Manual Rev G.1 Dec 2016

sample text

Symbols

Refer to instruction manual/booklet

General mandatory action sign

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. Protective earth ground

IPX1

Protection from dripping water from above the device

Defibrillation proof type BF applied part

CAUTION ONLY

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Federal law (USA) restricts this device to sale by or on the order of a physician.

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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 60601-187VL Medical Electrical Equipment 10:2008, 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

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Table of Contents Warning/Caution/Note Definition...4 Summary of safety precautions ...5 Introduction ...7 Product description ...7 Indications for use ...7 Intended users ...8 Expected service life ...8 Contraindications...8 Specifications...8 Product illustration ... 10 Product system ... 11 Product functions ... 12 Buttons ... 12 Visual indicators... 13 Graphical user interface icons... 14 Product alarms ... 15 Alarm priority and description ... 15 Contact information... 18 Serial number location... 18 Date of manufacture ... 18 Setup... 19 Inspecting ... 19 Selecting a language... 19 Testing visual and audible alarms ... 19 Operation ... 21 Placing the product ... 21 Applying or releasing the wheel locks... 21 Selecting and connecting a temperature probe ... 22 Connecting the reusable patient temperature output cable ... 22 Connecting the insulated hoses ... 23 Disconnecting the insulated hoses ... 24 Connecting and disconnecting thermal transfer devices ... 24 Powering on the product ... 25 Removing and replacing the reservoir ... 26 Filling the reservoir with sterile distilled water ... 26 Selecting and setting the primary probe... 27 Filling a thermal transfer device ... 28 Selecting a therapy mode... 28 Starting Automatic therapy mode ... 29 Setting or editing the cooling rates. ... 29 Setting or editing the warming rates ... 30 Starting Manual mode ... 30 Starting Monitor mode ... 31

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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

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

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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° 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.

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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 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

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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

120VAC, 60Hz 12A

Physical dimensions Height Width Depth Empty weight Filled weight Reservoir capacity

42.5 in. 15.0 in. 23.0 in. 150.0 lb 160.5 lb 1.3 gal

107.9 cm 38.1 cm 58.4 cm 68.0 kg 72.8 kg 5.0 L

Control setting range

39.2° - 104.0° F

4.0° - 40.0° 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° F

Water temperature

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40.0° C

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Introduction Specifications (Continued) Patient temperature Control setting range

89.6° - 100.4° F

Control accuracy

±0.1° C (32° - 38° C)

Measurement accuracy

±0.3° C (25.0° - 45.0° C)

32.0° - 38.0° C

±0.4° C (0.0° C - 24.9° C, 45.1° C - 50.0° C) Display / resolution setting

0.1° C

Display range

32.0° - 122.0° F

0.0° - 50.0° C

Default setting

98.6° F

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

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

Clinical thermometer

Direct mode

Equipment Class

Class I

4.2 - 4.5 meters

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

Ambient temperature

Storage 89.9°F (32.2°C)

59°F (15°C)

Relative humidity (noncondensing)

-40°F (-40°C)

30 %

140 °F (60 °C) -20°F (-29°C)

95 % 10 %

1060 hPa 700 hPa

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140 °F (60 °C)

75 %

Atmospheric pressure

Transporta tion

95 % 25 %

1060 hPa

Not applicable

500 hPa

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Introduction Product illustration

G A

H

D E

I

F J B

L

C M

K

Figure 1: Controller, patient front Figure 2: Controller, patient back

A

Storage compartment

G

Graphical user interface display

B

Removable water reservoir

H

Handle

C

Front wheels

I

Power cord

D

Patient probe ports

J

Hose and power cord management straps

E

Patient temperature output port

K

Swivel casters

F

Hose connection ports

L

Wheel locks

M

Ground chain

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Introduction Product system

Figure 3: Altrix system - controller with thermal transfer devices

Figure 4: Closed loop system 1

Human machine interface (HMI) system

6

Controls

2

Physical boundary

7

Flow system

3

Patient system

8

Energy transfer system

4

Patient temperature port

9

Water flow

5

Fluid delivery system

10

Signals

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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

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Name

Function

Stand-by

Press and hold the button for two seconds to stop therapy or power off

Therapy paused

Press and hold the button for two seconds to pause or resume therapy

View temperature

Select temperature degree in Celsius or Fahrenheit

Lock / unlock screen

Press and hold the button for two seconds to lock or unlock the graphical user interface

Audio paused

Pause or resume the audible indicator when an alarm is active. 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.

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)

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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

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.

Back

Returns to the previous screen or cancel an operation

Edit settings, Exit, or Cancel

Edit current settings, exit, or cancel

Confirm selection

Accepts the selected settings

Next or More

Changes to the next screen, option, or setting

Page indicators (may also appear vertical)

Indicates that there is more than one page associated with the screen topic for the page that is currently displayed

Settings

Displays the summary of the current, visual / audible, language, or primary probe settings

Graph

Graphical display of the selected items such as patient temperature, target temperature, water temperature, and power level

Help

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)

, dims or brightens the LCD based on the amount of light in the room.

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.

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Introduction 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 Stand-by

Water flow detected, ports 1, 2, or 3 are active, solid green when active, does not breathe 1

2

3

Graphical user interface icons Icon

Name Cooling therapy

Warming therapy

1

     

2

     

Current therapy duration Total duration Visual and audible tests

   |

14

Target patient or water temperature

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Introduction Product functions (Continued) Icon

Name Medium: patient temperature increases at a rate of 4.0° C in 12 hours (0.33° C/ hour). Med

Maximum: water temperature approaches water target as fast as possible Max

Minimum: patient temperature increases at a rate of 4.0° C in 24 hours (0.17° C/hour). Min

Set Custom

Max

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

Med

Medium: water is cooled to target, with a max of 15.0° C difference between the patient and the water temperature

Min

Minimum: water is cooled to target, with a max of 10.0° C difference between the patient and the water temperature

Product alarms Audible alarms work in conjunction with the display.

Alarm priority and description Priority alarm

Audible reminder

Icon flashes

Medium

Repetitive burst of three beeps every 25 seconds

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.

Low

Single burst of two beeps

The icon does not flash when there is a low priority alarm.

Audio pause

Button breathes as a reminder

Pausing the alarm will not stop the icon from flashing.

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.

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Introduction Product alarms (Continued) Icon, yellow

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Name

Alarm priority and delay

Message

Therapy interrupted

Check

Water temperature deviation

Medium

Water temperature is ±0.8° C (1.4° F) outside of target temperature

No

Temporary condition upon startup, addition of thermal transfer device, or addition of water

No water

Medium, 20 second delay

No water

Yes

Check for leaks Add a minimum of 2 liters of water

No water flow

Medium, 20 second delay

No flow detected

Yes

Check for leaks and obstructions at connections, hoses, and thermal transfer devices

Check water flow on any port

Medium, 60 second delay

Reduced flow detected

No

Tap Confirm, if the water port was removed intentionally Check for leaks and obstructions at connections, hoses, and thermal transfer devices

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