Stryker Altrix Operation Manual
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Stryker Altrix Operation Manual

Precision temperature management system
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A A l l t t r r i i x x ® ® P P r r e e c c i i s s i i o o n n T T e e m m p p e e r r a a t t u u r r e e M M a a n n a a g g e e m m e e n n t t S S y y s s t t e e m m
O O p p e e r r a a t t i i o o n n s s M M a a n n u u a a l l
8001
EN
8001-109-001 Rev C.0
2019/09

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  • Page 1 A A l l t t r r i i x x ® ® P P r r e e c c i i s s i i o o n n T T e e m m p p e e r r a a t t u u r r e e M M a a n n a a g g e e m m e e n n t t S S y y s s t t e e m m O O p p e e r r a a t t i i o o n n s s M M a a n n u u a a l l 8001 8001-109-001 Rev C.0...
  • Page 3 Consult instructions for use General warning Caution Warning; electricity Catalogue number / model Serial number For US Patents see www.stryker.com/patents Manufacturer Mass of equipment Direct current Alternating current Product provides terminal for connection of a potential equalization conductor. The potential equalization conductor provides direct connection between the product and potential equalization busbar of the electrical installation.
  • Page 4 In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended, this symbol indicates that the product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling. Medical Equipment Classified by Underwriters Laboratories Inc.
  • Page 5 T T a a b b l l e e o o f f C C o o n n t t e e n n t t s s Warning/Caution/Note Definition ..........................3 Summary of safety precautions ..........................4 Introduction ................................6 Product description ..............................6 Indications for use..............................6 Intended users................................7...
  • Page 6 Storing the controller .............................34 Transporting the product............................34 Cleaning ..................................36 Cleaning the external surfaces ..........................36 Disinfecting ................................37 Disinfecting external surfaces ..........................37 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 and parts...
  • Page 7 W W a a r r n n i i n n g g / / C C a a u u t t i i o o n n / / N N o o t t e e D D e e f f i i n n i i t t i i o o n n The words W W A A R R N N I I N N G G , C C A A U U T T I I O O N N , and N N O O T T E E carry special meanings and should be carefully reviewed.
  • Page 8 W W A A R R N N I I N N G G • 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.
  • Page 9 • Always remove the product from use before servicing any components. Contact qualified service personnel for service. N N o o t t e e - - Disinfection of the Altrix internal water system was validated using M. mucogenicum. 8001-109-001 Rev C.0...
  • Page 10 P P r r o o d d u u c c t t d d e e s s c c r r i i p p t t i i o o n n The Stryker model 8001A A l l t t r r i i x x ® Precision Temperature Management System can supply water to an individual or multiple thermal transfer devices simultaneously with each of these circuits monitored separately.
  • Page 11 • 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 I I n n t t e e n n d d e e d d u u s s e e r r s s •...
  • Page 12 N N o o t t e e - - The controller takes approximately 9 minutes to heat from 23.0±2° C (73.4° F) to 37.0° C (98.6° F) when not connected to a patient. Time will vary when connected to a patient. Stryker reserves the right to change specifications without notice. For more information about thermal transfer devices, cables, or probes, see the manufacturer’s instructions for use.
  • Page 13 E E n n v v i i r r o o n n m m e e n n t t a a l l S S t t o o r r a a g g e e T T r r a a n n s s p p o o r r t t a a t t i i o o n n O O p p e e r r a a t t i i o o n n c c o o n n d d i i t t i i o o n n s s...
  • Page 14 P P r r o o d d u u c c t t s s y y s s t t e e m m F F i i g g u u r r e e 3 3 – – A A l l t t r r i i x x s s y y s s t t e e m m - - c c o o n n t t r r o o l l l l e e r r w w i i t t h h t t h h e e r r m m a a l l t t r r a a n n s s f f e e r r d d e e v v i i c c e e s s F F i i g g u u r r e e 4 4 –...
  • Page 15 P P r r o o d d u u c c t t f f u u n n c c t t i i o o n n s s 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.
  • Page 16 I I c c o o n n N N a a m m e e F F u u n n c c t t i i o o n n Increase Increases the water or patient temperature by 0.1° for cooling or warming temperature N N o o t t e e - - Press and hold the increase button to move the temperature up faster.
  • Page 17 I I c c o o n n , , g g r r e e e e n n N N a a m m e e 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 solid green when active...
  • Page 18 I I c c o o n n N N a a m m e e Total duration Visual and audible tests Target patient or water temperature 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°...
  • Page 19 I I c c o o n n , , y y e e l l l l o o w w N N a a m m e e A A l l a a r r m m p p r r i i o o r r i i t t y y M M e e s s s s a a g g e e T T h h e e r r a a p p y y C C h h e e c c k k...
  • Page 20 Competent authority of the European Member State where the user and/or patient is established. 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.
  • Page 21 S S e e r r i i a a l l n n u u m m b b e e r r l l o o c c a a t t i i o o n n D D a a t t e e o o f f m m a a n n u u f f a a c c t t u u r r e e The year of manufacture is the first four digits of the serial number.
  • Page 22 S S e e t t u u p p Unpack the cartons and check all items. Make sure that the product is free from visual damage before putting into service. C C A A U U T T I I O O N N •...
  • Page 23 4. Tap Confirm. N N o o t t e e • 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.
  • Page 24 S S e e l l e e c c t t i i n n g g a a n n d d c c o o n n n n e e c c t t i i n n g g a a t t e e m m p p e e r r a a t t u u r r e e p p r r o o b b e e W W A A R R N N I I N N G G - - Always use Stryker accessories. Only IEC 60601-1 equipment shall be hooked to the patient temperature ports.
  • Page 25 400 series compatible external device for temperature accuracy. W W A A R R N N I I N N G G - - Always use Stryker accessories. Only IEC 60601-1 equipment shall be hooked to the patient temperature ports.
  • Page 26 W W A A R R N N I I N N G G • 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.
  • Page 27 C C A A U U T T I I O O N N • Avoid the use of materials of good thermal conductivity, such as water, gel, or similar substances, with the A A l l t t r r i i x x system not powered on.
  • Page 28 N N o o t t e e - - The term “thermal transfer devices” is used throughout this manual and is interchangeable with blankets and wraps, unless indicated otherwise. P P o o w w e e r r i i n n g g o o n n t t h h e e p p r r o o d d u u c c t t The operator should stand in front of the controller within arm’s reach.
  • Page 29 R R e e m m o o v v i i n n g g a a n n d d r r e e p p l l a a c c i i n n g g t t h h e e r r e e s s e e r r v v o o i i r r The removable reservoir enables you to fill or drain the reservoir away from the controller without interrupting therapy.
  • Page 30 F F i i g g u u r r e e 1 1 7 7 – – R R e e s s e e r r v v o o i i r r f f i i l l l l l l i i n n e e s s S S e e l l e e c c t t i i n n g g a a n n d d s s e e t t t t i i n n g g t t h h e e p p r r i i m m a a r r y y p p r r o o b b e e A patient probe displays when present, stable, and confirmed.
  • Page 31 • Always check the integrity of the patients skin and temperature according to hospital protocol when using the A A l l t t r r i i x x system. • 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.
  • Page 32 N N o o t t e e • The controller determines W W a a r r m m i i n n g g or C C o o o o l l i i n n g g therapy based on the selected water target temperature and the current water temperature.
  • Page 33 F F i i g g u u r r e e 1 1 8 8 – – S S e e t t c c u u s s t t o o m m w w a a r r m m i i n n g g r r a a t t e e 3.
  • Page 34 S S w w i i t t c c h h i i n n g g m m o o d d e e s s Tap Edit and select a different therapy mode. P P a a u u s s i i n n g g a a n n d d r r e e s s u u m m i i n n g g t t h h e e r r a a p p y y To pause therapy, press and hold the Pause Therapy button for two seconds.
  • Page 35 O O p p e e n n i i n n g g a a n n d d s s e e c c u u r r i i n n g g i i t t e e m m s s i i n n t t h h e e s s t t o o r r a a g g e e c c o o m m p p a a r r t t m m e e n n t t The storage compartment holds a maximum of 3 lb (1.36 kg).
  • Page 36 9. Discard the disposable thermal transfer devices based on your local waste management protocol. a. Discard the disposable thermal transfer devices based on your local waste management protocol, if applicable. D D r r a a i i n n i i n n g g w w a a t t e e r r f f r r o o m m t t h h e e r r e e s s e e r r v v o o i i r r To drain the water from the reservoir: 1.
  • Page 37 F F i i g g u u r r e e 2 2 2 2 – – C C l l i i k k - - T T i i t t e e o o p p e e n n 4.
  • Page 38 F F i i g g u u r r e e 2 2 3 3 – – M M a a n n a a g g e e m m e e n n t t s s t t r r a a p p s s S S t t o o r r i i n n g g t t h h e e c c o o n n t t r r o o l l l l e e r r Storage is equal to or greater than 7 days without use.
  • Page 39 3. Make sure to place the product with the ports facing the front (Figure 24). F F i i g g u u r r e e 2 2 4 4 – – T T r r a a n n s s p p o o r r t t p p o o s s i i t t i i o o n n 4.
  • Page 40 C C l l e e a a n n i i n n g g C C l l e e a a n n i i n n g g t t h h e e e e x x t t e e r r n n a a l l s s u u r r f f a a c c e e s s Clean the external surfaces of the controller and system components before each use.
  • Page 41 D D i i s s i i n n f f e e c c t t i i n n g g D D i i s s i i n n f f e e c c t t i i n n g g e e x x t t e e r r n n a a l l s s u u r r f f a a c c e e s s Disinfect the external surfaces of the controller and system components before each use.
  • Page 42 • Power cord • Hose and power cord management straps • Storage compartment door • Inside storage compartment • Graphical user interface display • Handle 14. Follow specified contact time in accordance with the disinfectants manufacturer’s instructions for use. 15. To rinse, wipe the hoses and patient temperature probe cables, with a soft, lint free cloth moistened with sterile distilled water.
  • Page 43 D D i i s s i i n n f f e e c c t t t t h h e e i i n n t t e e r r n n a a l l w w a a t t e e r r c c i i r r c c u u i i t t a a n n d d h h o o s s e e s s e e v v e e r r y y 1 1 4 4 d d a a y y s s Use the B B r r u u C C l l e e a a n n T T b b C C disinfectant tablets manufactured by B B r r u u l l i i n n (EPA registration number 71847-2-106) before first use, at least every 14 days, and before storage.
  • Page 44 F F i i g g u u r r e e 2 2 5 5 – – D D r r a a i i n n p p l l u u g g 4. Connect a hose to each port (Figure 26). F F i i g g u u r r e e 2 2 6 6 –...
  • Page 45 F F i i g g u u r r e e 2 2 8 8 – – C C l l i i k k - - T T i i t t e e h h o o s s e e e e n n d d s s a a r r e e c c l l o o s s e e d d a a n n d d c c l l a a m m p p s s a a r r e e o o p p e e n n 6.
  • Page 46 F F i i g g u u r r e e 3 3 0 0 – – D D i i s s c c o o n n n n e e c c t t e e d d h h o o s s e e 6.
  • Page 47 21. Pull up on the controller drain plug (Figure 32) to open the drain. F F i i g g u u r r e e 3 3 2 2 – – D D r r a a i i n n p p l l u u g g 22.
  • Page 48 9. Tap Confirm. 10. Allow the controller to run for 2 minutes to purge air from the system. 11. Allow the controller to run for 5 minutes. N N o o t t e e - - The timer will run on the main display, follow the current therapy duration timer. 12.
  • Page 49 T T h h e e r r m m a a l l t t r r a a n n s s f f e e r r d d e e v v i i c c e e s s These accessories are currently available for purchase. Not all accessories are available for all regions. Call Stryker Customer Service at 1-800-327-0770 for availability and pricing.
  • Page 50 K K i i t t p p a a r r t t n n u u m m b b e e r r C C o o n n t t e e n n t t s s Q Q u u a a n n t t i i t t y y T T y y p p e e o o f f C C o o n n n n e e c c t t o o r r 8001-061-650...
  • Page 51 Insulated C C o o l l d d e e r r C C o o n n n n e e c c t t o o r r Hose 8001-064-135 Altrix® Temperature Management Hose™ 8003-002-007 8001-109-001 Rev C.0...
  • Page 52 T T r r o o u u b b l l e e s s h h o o o o t t i i n n g g P P r r o o b b l l e e m m P P o o s s s s i i b b l l e e c c a a u u s s e e A A c c t t i i o o n n R R e e m m o o v v e e f f r r o o m m u u s s e e...
  • Page 53 P P r r o o b b l l e e m m P P o o s s s s i i b b l l e e c c a a u u s s e e A A c c t t i i o o n n R R e e m m o o v v e e f f r r o o m m u u s s e e Patient temperature...
  • Page 54 Remove the product from service before you perform the preventive maintenance inspection. Check all items listed during annual preventive maintenance for all Stryker Medical products. You may need to perform preventive maintenance checks more often based on your level of product usage. Service only by qualified service technician.
  • Page 55 C C l l e e a a n n i i n n g g t t o o o o l l s s D D e e s s c c r r i i p p t t i i o o n n P P a a r r t t N N u u m m b b e e r r B B r r u u C C l l e e a a n n T T b b C C tablets 8001-999-228...
  • Page 56 A A l l a a r r m m c c o o n n d d i i t t i i o o n n s s The alarm rank establishes the order of presentation of the alarm on-screen message. The D in the table indicates the alarm is deactivated during that mode.
  • Page 57 C C h h e e c c k k p p a a t t i i e e n n t t p p r r o o b b e e a a l l a a r r m m This alarm notifies the operator that data provided by the probe is not normal or appears removed.
  • Page 58 P P a a t t i i e e n n t t t t e e m m p p e e r r a a t t u u r r e e d d e e v v i i a a t t i i o o n n l l o o w w a a l l a a r r m m This alarm notifies the operator that the patient is not responding as expected in the active therapy.
  • Page 59 • You have selected an outlet port and the flow is lower than 0.8l /min for a period of 10 minutes or more. The product will display a Check Water Flow Alarm for the given port. • Good flow is reduced to Low flow for > 10 minutes or reduced to No flow for > 15 seconds. N N o o t t e e •...
  • Page 60 T T h h e e r r a a p p y y p p a a u u s s e e d d t t i i m m e e o o u u t t a a l l a a r r m m This alarm converts a therapy pause into an alarm if the duration of the pause is too long.
  • Page 61 E E M M C C I I n n f f o o r r m m a a t t i i o o n n G G u u i i d d a a n n c c e e a a n n d d m m a a n n u u f f a a c c t t u u r r e e r r ’ ’ s s d d e e c c l l a a r r a a t t i i o o n n - - e e l l e e c c t t r r o o m m a a g g n n e e t t i i c c e e m m i i s s s s i i o o n n s s The A A l l t t r r i i x x system is intended for use in the electromagnetic environment specified below.
  • Page 62 R R e e c c o o m m m m e e n n d d e e d d s s e e p p a a r r a a t t i i o o n n s s d d i i s s t t a a n n c c e e s s b b e e t t w w e e e e n n p p o o r r t t a a b b l l e e a a n n d d m m o o b b i i l l e e R R F F c c o o m m m m u u n n i i c c a a t t i i o o n n s s e e q q u u i i p p m m e e n n t t a a n n d d t t h h e e A A l l t t r r i i x x s s y y s s t t e e m m 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...
  • Page 63 G G u u i i d d a a n n c c e e a a n n d d m m a a n n u u f f a a c c t t u u r r e e r r ’ ’ s s d d e e c c l l a a r r a a t t i i o o n n - - e e l l e e c c t t r r o o m m a a g g n n e e t t i i c c i i m m m m u u n n i i t t y y Portable and mobile RF communications equipment should be used no closer to...
  • Page 64 G G u u i i d d a a n n c c e e a a n n d d m m a a n n u u f f a a c c t t u u r r e e r r ’ ’ s s d d e e c c l l a a r r a a t t i i o o n n - - e e l l e e c c t t r r o o m m a a g g n n e e t t i i c c i i m m m m u u n n i i t t y y N N o o t t e e - - 1- At 80 MHz and 800 MHz, the higher frequency range applies.
  • Page 65 8 8 0 0 0 0 1 1 - - 0 0 0 0 0 0 - - 4 4 6 6 0 0 Rev F 0058-372-000 8001-109-001 Rev C.0...
  • Page 66 8 8 0 0 0 0 1 1 - - 1 1 2 2 3 3 - - 4 4 1 1 0 0 Rev AA 8001-500-810 8001-109-001 Rev C.0...
  • Page 67 8 8 0 0 0 0 1 1 - - 1 1 0 0 0 0 - - 4 4 2 2 0 0 Rev AA 8001-400-800 (MCB) 8001-109-001 Rev C.0...
  • Page 68 8 8 0 0 0 0 1 1 - - 0 0 0 0 0 0 - - 5 5 1 1 0 0 Rev AA 8001-300-830 (CCB) 8001-000-500 (UIB) 8001-109-001 Rev C.0...
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  • Page 74 0 0 0 0 5 5 9 9 - - 4 4 2 2 6 6 - - 0 0 0 0 0 0 Rev F 0059-789-000 0059-788-000 8001-109-001 Rev C.0...
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  • Page 77 0 0 0 0 3 3 9 9 - - 2 2 3 3 2 2 - - 0 0 0 0 0 0 Rev E 0039-232-000 8001-109-001 Rev C.0...
  • Page 78 8 8 0 0 0 0 1 1 - - 1 1 2 2 3 3 - - 1 1 2 2 5 5 Rev J 8001-120-310 8001-109-001 Rev C.0...
  • Page 80 Stryker Medical 3800 E. Centre Avenue Portage, MI 49002 8001-109-001 Rev C.0 2019/09 WCR: AB.7...

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