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8001-009-001 REV G

55

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.

Emissions test

Compliance

Electromagnetic environment

RF Emissions

CISPR 11

Group 1

The

Altrix

system uses RF energy only for its

internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

RF Emissions

CISPR 11

Class A

The

Altrix

system is suitable for use in all

establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.

Harmonic Emissions

IEC 61000-3-2

Class A

220-240V/50Hz

220V/60Hz

Does not apply to 100V

50/60Hz or 120V/60Hz

Voltage Fluctuations

Flicker Emissions

IEC 61000-3-3

Complies

220-240V/50Hz only

Recommended separations distances between portable and mobile RF communications equipment and the

Altrix system

The

Altrix

system is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of

Altrix

can help prevent electromagnetic interference s by maintaining a

minimum distance between portable and mobile RF communications equipment (transmitters) and the

Altrix

system as

recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

D=(1.2) (√

P

)

80 MHz to 800 MHz

D=(0.35) (√

P

)

800 MHz to 2.5 GHz

D=(0.70) (√

P

)

0.01

0.12

0.035

0.07

0.1

0.38

0.11

0.22

1

1.2

0.35

0.7

10

3.8

1.1

2.2

100

12

3.5

7

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters

(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output

power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz,
the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Содержание altrix

Страница 1: ...2016 12 G 1 8001 009 001 REV G www stryker com Operations Manual Altrix Precision Temperature Management System 8001 ...

Страница 2: ...sample text ...

Страница 3: ...uipment 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 ONLY ...

Страница 4: ...disposal information 87VL Medical Electrical Equipment 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 N...

Страница 5: ...guage 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 r...

Страница 6: ...ining 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 ...

Страница 7: ...www stryker com 8001 009 001 REV G 3 Table of Contents To obtain parts and service 59 Return authorization 59 Damaged product 59 International warranty clause 59 ...

Страница 8: ...ous 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 ...

Страница 9: ...ter 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 inval...

Страница 10: ... 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 Al...

Страница 11: ...nitoring The controller alarms visual and audible indications for when safety parameters are exceeded or it detects system function or performance irregularities The Altrix system is able to provide a patient temperature output reference signal to be connected to a non specific third party device or system The controller regulates water temperatures between 4 0 C 39 2 F and 40 0 C 104 0 F and circ...

Страница 12: ...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...

Страница 13: ...ow rate in each hose port Typical 1 2 lpm Refrigerant type R134a Power cord length 14 to 15 feet 4 2 4 5 meters Clinical thermometer Direct mode Equipment Class Class I 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...

Страница 14: ... J L M 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 ...

Страница 15: ...trix 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 ...

Страница 16: ...ress 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...

Страница 17: ...pic 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 vi...

Страница 18: ...t probe A port stabilized Patient probe B port stabilized External device patient probe A External device patient probe B Stand by 3 2 1 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 1 Current therapy duration 2 Total duration Visual and audible tests Target patient or water temperatur...

Страница 19: ...nd 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 indicat...

Страница 20: ... 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 remove...

Страница 21: ...t temperature is 0 5 C 0 9 F outside of target temperature Only will appear after the initial target is reached No Check patient condition placement of thermal transfer devices and all connections Normothermia deviation Low Patient temperature is outside of 36 0 C 96 8 F to 38 0 C 100 4 F No Check patient condition placement of thermal transfer devices and all connections Therapy pause Medium Ther...

Страница 22: ...ppear on the alarm screen there are multiple active alarms The highest alarm is displayed Tap Next or Back to view the active alarms 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 S...

Страница 23: ...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...

Страница 24: ...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 ...

Страница 25: ... 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...

Страница 26: ... the Reusable Adapter Cable B to the controller A with the red dot on the patient probe port A or port B A B C 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 b...

Страница 27: ...o 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 co...

Страница 28: ...sult 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 Al...

Страница 29: ...truments 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...

Страница 30: ... you to fill or drain the reservoir away from the controller without interrupting therapy You will need to have the reservoir installed before starting a therapy CAUTION Do not place your fingers in between the reservoir and the sides of the controller to avoid the risk of pinching your fingers To remove the reservoir pull forward at an angle and lift out the reservoir Figure 15 on page 26 A B C F...

Страница 31: ...y probe A patient probe displays when present stable and confirmed The choice of Probe A or Probe B is highlighted when you insert the cable into port A and port B If you only insert one cable the active port displays 1 Tap the Settings button a In the standby mode tap the Back button to display the edit settings screen b In an active therapy mode tap the Next button 2 Tap Select Probe to display ...

Страница 32: ...mode You can select from one of three therapy modes and tap Confirm Automatic therapy Manual therapy 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 mixtu...

Страница 33: ...ient temperature 8 Tap the Automatic therapy mode button 9 Select the target patient temperature 10 See Setting or editing the cooling rates on page 29 or Setting or editing the warming rates on page 30 Notes The controller determines Warming or Cooling therapy based on the selected water target temperature and the current water temperature Do not place additional heat sources between the patient ...

Страница 34: ...ming rate 3 Tap Confirm 4 Tap the Edit button to make changes Starting Manual mode In Manual mode the therapy will cool or warm the water to a selected water target temperature The operator must observe the patient s temperature and manually adjust the water temperature to obtain the desired patient temperature 1 If desired select and place the sensing end of the patient probe based on hospital pr...

Страница 35: ...ased on hospital protocol Secure the patient probe to reduce the risk of accidental dislodgment 3 Tap the Monitor button 4 Connect the patient temperature probe to the end of the reusable adapter cable See Selecting and connecting a temperature probe on page 22 Note If the product senses a patient probe temperature below 36 0 C 96 8 F or above 38 0 C 104 F the normothermia alarm displays and an au...

Страница 36: ... for each variable 4 To exit tap the Graph icon or the Exit button Notes In monitor mode only the patient temperature data is displayed A The graph icon is only available when a therapy is active The patient data remains until the product sleeps or you powered off the product During a power loss the data is lost and not retrievable Opening and securing items in the storage compartment The storage ...

Страница 37: ...ore use Make sure that you drain the hoses before you put them in storage 1 Unplug the product 2 Remove the thermal transfer device from the patient 3 Open the clamps on the hoses and thermal transfer devices if applicable See Figure 14 on page 25 4 Raise the thermal transfer devices attached to the hose above the ports on the controller Gravity helps to drain the water into the controller 5 Allow...

Страница 38: ... floor drain 2 Remove the reservoir and pull up on the controller drain plug A to open the drain Figure 20 on page 34 A Figure 20 Drain plug 3 Connect a hose to each port a If you have Colder style connector hoses attach the service tool adapter hose 8001 999 017 b If you have Clik Tite hoses make sure that the connectors and clamps are open Figure 21 on page 34 Figure 21 Clik Tite open 4 Raise al...

Страница 39: ... 35 3 Unplug the power cord from the wall outlet and store with the management straps Figure 22 on page 35 Figure 22 Management straps Storing the controller Storage is equal to or greater than 7 days without use CAUTION Do not store the product with water in the device Always store the product within the specified environmental condition values To store the controller 1 See Disinfect the internal...

Страница 40: ...ang items on the controller handle to avoid the risk of tipping the product Always store the power cord cables and hoses before you transport the product to reduce the risk of trip hazard 1 Make sure that the pathway is clear 2 Unplug the product from the hospital grade or medical grade wall outlet See Storing the power cord and hoses on page 35 3 Make sure to place the product with the ports faci...

Страница 41: ...to disconnect 6 Disconnect the patient temperature probe cable from the port 7 Remove the reservoir Pull forward at an angle and lift out the reservoir 8 If necessary empty the water from the reservoir Dispose of the water per your hospital protocol 9 Prepare a mild soap and water solution as described by the manufacture 10 Wipe the inside and outside of the reservoir and reservoir lid with a soft...

Страница 42: ...Germicidal Cleaner EPA registration number 56392 7 To disinfect the external surfaces of the controller and system components See Product illustration on page 10 for clarification of product component names and locations 1 Use PPE as recommended by the disinfectant manufacturer s instructions 2 Unplug the power cord from the wall outlet 3 Apply the wheel locks 4 Unfasten the power cord and hose st...

Страница 43: ...ION 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 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 disinfe...

Страница 44: ... drain open A Figure 24 Drain plug 4 Connect a hose to each port Figure 25 on page 40 Figure 25 Hoses connected 5 Close the connector ends of all three hoses a If you have Colder style connector hoses attach the service tool adapter hose 8001 999 017 Figure 26 on page 40 Complete this for all three hoses Figure 26 Colder style connector hose connected to a tool adapter hose b If you have Clik Tite...

Страница 45: ... process Figure 28 Raise the hoses 7 Allow the controller and hoses to drain for a minimum of two minutes 8 Push down on the drain plug to close the drain Disinfecting the internal water circuit and hoses 1 Use personal protection equipment as recommended by the BruClean TbC disinfectant manufacturer s instructions for use 2 Put 2 BruClean TbC tablets into the reservoir 3 Using appropriate measuri...

Страница 46: ...d the Stand by button 9 Tap the Manual mode icon 10 Tap Confirm 11 Set the water target temperature to 25 0 C 77 0 F 12 Tap Confirm 13 Run the controller for 20 minutes 1 14 After 20 minutes turn the controller off by pressing and holding the Stand by button for two seconds 15 Unplug the power cord from the wall outlet 16 Place the controller over a floor drain 17 Remove the reservoir Pull forward...

Страница 47: ... down on the controller drain plug to close the drain 24 When the controller and hoses are drained continue to Rinsing the internal water circuit and hoses on page 43 Rinsing the internal water circuit and hoses 1 Using appropriate measuring equipment fill the empty reservoir with 1 gallons 3 8 L of sterile distilled water 2 Place the reservoir into the controller 3 Connect the bottom hose end to ...

Страница 48: ...voir 15 Remove the bottom hose end from the hydraulic connector adapter in the reservoir lid by pushing down on the collar 16 Empty water from the reservoir dispose of the water per hospital protocol 17 Pull up on the controller drain plug to open the drain 18 Make sure that all 3 hoses remain raised above the connection ports for draining 19 Allow the controller and hoses to drain for a minimum o...

Страница 49: ...8 5 in 52 cm to 72 cm Mul T Blanket adult Colder 8001 061 610 25 in x 64 in 64 cm x 163 cm Mul T Blanket pediatric Colder 8001 061 612 22 in x 33 in 56 cm x 84 cm Rapr Round small medium vest chest Colder 8001 061 630 32 in to 46 in 81 cm to 117 cm Rapr Round large vest chest Colder 8001 061 635 46 in to 54 in 117 cm to 137 cm Rapr Round leg wrap one size for the left or right leg thigh circumfere...

Страница 50: ...ensing probe 8001 063 409 4491 12FR General purpose temperature sensing probe 8001 063 412 4492 14FR Foley catheter temperature sensing probe 8001 063 414 4464 16FR Foley catheter temperature sensing probe 8001 063 416 4466 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...

Страница 51: ...ect temperature outside of range Replace temperature probe Check connections If damaged RFU Controller will not heat Reservoir is empty Fill reservoir tap Confirm that water has been added restart If filling the reservoir does not resolve Controller will not cool Reservoir is empty Fill reservoir tap Confirm that water has been added restart If filling the reservoir does not resolve Thermal transf...

Страница 52: ...s out of range As a result of one of the following patient probe disconnected controller in standby sleep mode patient temperature outside the range of 25 45 C To resume calibration Disconnect the external device from the reusable adapter cable Tap the Help button to display the alarm screens Find the Temperature Output Alarm screen Tap Confirm to restart calibration Wait until the Monitor is soli...

Страница 53: ... caster wheels for free swivel action Both rear wheels lock securely when the brake is applied Front and rear wheels are not loose or wobbly Battery backup functional Alarm system visual and audible LCD functional Touch screen functional Water temperature and flow verification Probe resistance Clear RFU codes Ground impedance not more than 100mΩ millohms Current leakage not more than 300 microamps...

Страница 54: ...50 8001 009 001 REV G www stryker com Cleaning tools Description Part Number BruClean TbC 13 1g tablet 52 count 8001 999 224 Service tool adapter hose 8001 999 017 ...

Страница 55: ...D 11 D 6 D D No water flow alarm all ports D 4 D 4 D D No water D 2 D 2 D D Therapy paused timed out D D 3 D 3 D Normothermia deviation D D D D D 5 Power backup level 1 19 19 14 14 6 Patient output deviation D 22 22 17 17 7 Notes If more than one alarm is active at the same time the product maintains the active state for the individual alarm including the audio pause timer The screen alarms are di...

Страница 56: ...rm generation The product will display the Patient Temperature Deviation Medium Alarm if after the initial achievement of the current patient temperature target the actual primary patient temperature becomes 0 5 C or more above or below the Current Target Temperature Patient temperature output deviation alarm This alarm notifies the operator that the patient temperature output is out of range or t...

Страница 57: ...erator to confirm the addition The removal of a port requires the operator to confirm The Check Water Flow Alarm for the given outlet port stops if the operator confirms removal When none of 3 ports has a flow higher than or equal to 0 6l min the product deactivates the heater exchange and generates a no flow alarm Otherwise the heater exchange will remain active as indicated by the current mode P...

Страница 58: ...lified service personnel for service Depending on the remove from use RFU condition text may or may not be displayed For example if there is a power loss Water temperature probes are out of the allowed range Program and data checksum error High thermal cutout test failed Backup power product replacement required Low or over safety temperature Pump over current Compressor power fault Heater power f...

Страница 59: ...nt and the Altrix system The Altrix system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Altrix can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Altrix system as recommended below according to the maximum o...

Страница 60: ...00 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Main power quality should be that of a typical commercial or hospital environment Voltage dips voltage variations and short interruptions on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5...

Страница 61: ...e transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Conducted RF IEC 61000 4 6 3 Vrms...

Страница 62: ...ally with accuracy 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 ...

Страница 63: ...by Stryker In no event shall Stryker be liable for incidental or consequential damages To obtain parts and service Stryker products are supported by a nationwide network of dedicated Stryker Field Service Representatives These representatives are factory trained available locally and carry a substantial spare parts inventory to minimize repair time Simply call your local representative or call Str...

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Страница 66: ...2016 12 8001 009 001 REV G www stryker com Stryker Medical 3800 E Centre Avenue Portage MI 49002 USA ...

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