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Allon

User Manual

DDT-063-000 Rev C Belmont Medical Technologies

Page 4 of 106

Disclaimer

Belmont Medical Technologies is not responsible for any consequential or incidental

damages or expenses of any kind, impairment of or damage to other goods caused

by the following:
a. Installed, operated, maintained contrary to Belmont Medical Technologies

instructions, notes, or warnings under this manual.

b. Ignoring any of the warnings, precautions and safety measures indicated in this

manual.

c. Replacement, repair or alteration not performed by Belmont Medical

Technologies or authorized personnel.

d. The use of accessories and other parts or equipment made by other

manufacturers, whether or not warranted by such manufacturers, which have

been attached or connected to the System after installation, unless such

accessories and other parts have been supplied and attached or installed by

Belmont Medical Technologies.

e. Using the system in a contrary manner than indicated in this manual or using the

system for any purpose other than indicated in the manual.

Содержание 200-00263

Страница 1: ...Allon User Manual DDT 063 000 Rev C English...

Страница 2: ...s 780 Boston Road Billerica MA 01821 USA Technical Service 885 397 4547 USA 1 978 663 0212 WORLDWIDE www BelmontMedTech com European Representative Emergo Europe BV Prinsessegracht 20 2514 Ap The Hagu...

Страница 3: ...ways accompany the system All qualified personnel operating the system should know the location of the manual For additional copies of this manual please contact your Belmont Medical Technologies repr...

Страница 4: ...precautions and safety measures indicated in this manual c Replacement repair or alteration not performed by Belmont Medical Technologies or authorized personnel d The use of accessories and other pa...

Страница 5: ...MATION 62 Equipment and Accessories 62 CHAPTER 6 MAINTENANCE 65 Introduction 65 Service Information 65 Routine Maintenance 65 Cleaning and Disinfection 66 Routine Maintenance 67 Cleaning Disinfecting...

Страница 6: ...63 Table 8 Accessories Individual Replacement 64 Table 9 Inspection and Maintenance Schedule 66 Table 10 Allon System No Message Troubleshooting Guide 75 Table 11 Water Tank Overfilled Draining the W...

Страница 7: ...mp Graph Mode 50 Figure 25 Settings Screen 52 Figure 26 All Temp Sensors Alarm Off Indicator 53 Figure 27 Adjustable Alarm Limits 54 Figure 28 Set Date and Time 55 Figure 29 Services Screen 56 Figure...

Страница 8: ...2 The patient should be under constant supervision of the medical staff 3 The misuse of the temperature regulation equipment can be potentially harmful to the patient 4 Do not plug wet probes into the...

Страница 9: ...s 17 Wrap should not come in contact with open wounds 18 Do not touch the ribbon cable behind the display and the patient simultaneously Precautions 1 Follow the warning notes listed in the various se...

Страница 10: ...ent and the Wrap 12 Storage of Wraps is recommended at temperatures 10 C to 27 C and 10 90 humidity EMC Safety For safe use of the Allon it is required to keep the Allon at a safe distance from device...

Страница 11: ...in body temperature WARNING The technical principles clinical applications and risks associated with circulatory support must be thoroughly understood before using this product Read the entire manual...

Страница 12: ...chnologies Page 12 of 106 Label Symbols Table 1 Label Symbols Description Symbol AC Voltage Fuse CE mark of conformity indicates that the product has received the European approval for MDD 93 42 EEC R...

Страница 13: ...2 Label Symbols Description Symbol Date of manufacture XX XX XXXX Manufacturer Name Do not push Refer to Instruction manual booklet Restricts the sale and use of this instrument to qualified medical p...

Страница 14: ...ontrol unit The control unit constantly monitors the patient s core temperature every 133 milliseconds through specific sensors and using its on board body temperature control algorithm adjusts water...

Страница 15: ...ased on the desired set point temperature and the actual measured patient temperature Core and Surface Water pressure and flow in the wrap is regulated by timed pauses of the flow during clinical oper...

Страница 16: ...Page 16 of 106 External Features Front View Water Level Indicator Water out Quick Coupling Connector Core Sensor Socket Adjustable Control Panel Handle Surface Sensor Socket Water In Quick Coupling C...

Страница 17: ...Allon User Manual DDT 063 000 Rev C Belmont Medical Technologies Page 17 of 106 Side View Figure 3 Side View...

Страница 18: ...Allon User Manual DDT 063 000 Rev C Belmont Medical Technologies Page 18 of 106 Rear Panel Figure 4 Rear View...

Страница 19: ...wrapped around the appropriate area of the patient e g chest arms and thighs to ensure maximum body surface coverage The water s exit and entrance points are short sections of tubing integrated with...

Страница 20: ...Belmont Medical Technologies Page 20 of 106 Wrap Material Patient side Non Woven Polypropylene Exterior Brushed Loop Fabric Usage Duration The wrap is durable for up to 28 hours It is recommended to r...

Страница 21: ...ss to the torso and legs Universal ThermoWrap is used for any typical surgery other than open heart surgery For available sizes see Table 3 Universal Pediatric ThermoWrap is used for pediatric surgery...

Страница 22: ...ight or infant weight see Figure 9 For adult type of operation to be performed cardiac or other The model type model number and sizes are listed on the label on each package Choose the appropriate mod...

Страница 23: ...oWrap Universal 512 03166 12 Box 168 180cm 1 904 1 321 512 03160 12 Box 152 168cm 1 934 1 295 512 03153 12 Box 135 152cm 1 744 1 212 ThermoWrap Universal Pediatric 512 03148 12 Box 122 135cm 1 582 1 1...

Страница 24: ...60 seconds 1 Reusable Temperature Probes There are three color coded temperature probes Core gray Surface green and Infant Core gray Both core and surface temperature probes must be plugged into the...

Страница 25: ...ble probes supplied by Belmont Medical Technologies CAUTION The sterilization of the disposable temperature probes are guaranteed by the manufacturer only CAUTION Before use check the packaging and ex...

Страница 26: ...00028 Adaptor Cable for Disposable Core Temperature Probe Gray 014 00322 Disposable Core Temperature Probe 20 pack Table 5 Reusable Sensor and Data Provider Input Specifications Part No Name Descripti...

Страница 27: ...moWrap end 5 Male Connector for Draining Water Tank See Table 8 Accessories Inventory 6 Spare Water Filter For annual filter replacement refer to Service Manual for instructions 7 Handle The handle is...

Страница 28: ...Allon User Manual DDT 063 000 Rev C Belmont Medical Technologies Page 28 of 106 System Specifications See the following page for system specifications Figure 11 Temperature Splitter...

Страница 29: ...tmosphere with flammable anesthetic mixtures Environmental Storage Conditions Temperature 15 C to 68 C 5 154 F Humidity 10 to 93 non condensing Hardware Electricity Input Power 230 115 VAC Switchable...

Страница 30: ...mperature High Water Temperature Displayed Information Mode of Operation Care Time System Status and alarms Set Point Temperature Normothermia Mode Water Out Temperature Manual Mode Patient Core Tempe...

Страница 31: ...ze 35 x 65 mm Controller MSP4301611 Micro controller with the following features Built in Flash and RAM Built in UART SPI Built in DMA controller Memory Flash memory capacity 2 MB Power Requirement 5...

Страница 32: ...m D x 940 mm H 10 23 W x 24 6 D x 37 H Electrical Requirements 115 230 VAC 690 Watts CAUTION Verify that the voltage switch is set for the local voltage Unpacking and Inspection The Allon device has u...

Страница 33: ...e Assembling the Handle 1 To assemble the handle 1 Release the four thumb screws by hand 2 Slide the two ends of the handle into the holes in the top cover pay attention to the direction of the curve...

Страница 34: ...evice Spare Filter Power Cable User Manual Quick Reference Guide Accessories Kit for Allon one of the following o 200 00400 Adult Accessory Kit with Reusable Temperature Probes o 200 00410 Accessory K...

Страница 35: ...Trolley Wheels The Allon device trolley has four wheels The front wheels are fitted with a brake The brake lever is located over the wheel To lock the wheels firmly press the lever To release the whee...

Страница 36: ...The silver push button to the right of the main power switch on the back of the unit turns off the yellow LED on the front of the unit This LED will flash each time the machine is powered down loses p...

Страница 37: ...ble control panel is located at the top of the Allon device Once the Allon device is turned on all operating functions are controlled through the control panel Allon has a touch screen with the follow...

Страница 38: ...the operating table or the patient s bed 2 Press the brake pedals and lock the wheels to secure the Allon device 3 Remove the water tank feeder cover and pour in sterile water or 0 22 filtered water...

Страница 39: ...er to ensure the proper functioning of the Allon device A self test is conducted every time the system is restarted In the event of a power failure of less than 10 minutes the self test will not be pe...

Страница 40: ...ails NOTE Some of the messages will halt the Allon device Other messages allow the completion of the self test but display the actions you need to take to correct the message state Pre heating Water A...

Страница 41: ...e sure that no electrical device or outlet is located under the device s water inlet or wrap tubes When disconnecting wraps confirm that the clamps are tight to prevent water leakage from thewrap 9 Co...

Страница 42: ...e attached to the patient NOTE Reusable temperature probes are not applicable for US market or other select markets To connect the temperature probes 1 Insert the core and surface temperature probes o...

Страница 43: ...n Screen After the Preheating Water step is completed the system automatically enters the main screen default Normothermia Mode Use the Setting screen to configure your default settings see Settings F...

Страница 44: ...if there is an Alarm condition This icon is informative only and not an action button It is not a touch button the soft key alarm button must be pressed to silence alarms Menu Options Touch the Menu i...

Страница 45: ...ture at the appropriate level to be ready when returning to operational mode NOTE During Standby Mode there is no temperature regulation and therefore the patient temperature is not being controlled b...

Страница 46: ...063 000 Rev C Belmont Medical Technologies Page 46 of 106 Mode Select Mode Select allows you to choose between Normothermia mode and Manual mode Select the mode you want to use and touch OK to confirm...

Страница 47: ...ION The desired set point temperature should only be set by the physician or under the order of a physician The Normothermia range is between 36 C and 38 C Lower or higher temperatures are indicated o...

Страница 48: ...n the desired set point temperature NOTE The default setting is intended to maintain normothermia However the system provides the physician with the option of selecting a body temperature in the range...

Страница 49: ...water temperature selection range is 36 C 40 C 96 8 F 105 8 F NOTE Alarms and warnings are the same as in Normothermia mode Temperature Graph This option displays up to 11 days of a graphic readout of...

Страница 50: ...d at the top of the graph The time from the beginning of the procedure is displayed on the X axis The temperature is shown on the Y axis Use the arrows on the screen to scroll back to beginning of the...

Страница 51: ...ting section in the Menu 2 To enter the Settings screen you need to enter a 4 digit password known only to trained authorized personnel Password write in the box After entering the correct password th...

Страница 52: ...he Language setting allows you to change the language of the control panel interface Temp Sensor Alarms This setting allows you to disable the following alarms o Patient temperature too high o Patient...

Страница 53: ...nce setting the Temperature Sensor Alarms to Off a constant blue message appears on the main screen Degree Select temperature unit presentation Centigrade or Fahrenheit Start up mode Select the defaul...

Страница 54: ...e adjustable alarms are High Patient Temperature o Range from 38 C to 40 C in 0 5 C steps Low Patient Temperature o Range from 30 C to 35 C in 0 5 C steps High Water Temperature o Range from 36 C to 4...

Страница 55: ...on User Manual DDT 063 000 Rev C Belmont Medical Technologies Page 55 of 106 Section 3 Set Date and Time This section allows you to adjust the date and the time of the system Figure 28 Set Date and Ti...

Страница 56: ...the system of the remaining water prior to storage of the Allon system To empty the water tank 1 Switch to Standby Mode see Standby 2 Disconnect the wrap Dispose of the wrap 3 Connect the Special Mal...

Страница 57: ...re 30 Empty Mode 5 When ready for the process to begin touch Start Emptying starts and the following screen appears 6 Wait for all the water to drain from the system NOTE If Stop is touched the ESC ic...

Страница 58: ...procedure NOTE The recommendations for emptying the water tank depend on the frequency of usage For frequent usage 3 4 times a week drain the water at least once a week For infrequent usage drain the...

Страница 59: ...ile or 0 22 filtered water Do NOT use bleach or any other cleaning and disinfectant agent for the internal circulation except sodium dichloroisocyanurate NaDCC These agents may harm the system and res...

Страница 60: ...the power cord from the power source 2 Once the machine is powered off press the Power Loss Alarm Disable next to the power switch to disable the yellow power loss indicator on the front of the machin...

Страница 61: ...ic plastic waste 13 Disinfect the surface of the connecting tubes and the exterior of the Allon device see instructions in Chapter 6 14 Dispose of disposable temperature probes in accordance with hosp...

Страница 62: ...el ThermoWrap is twelve units or any multiplication of twelve ThermoWraps for infant models are packed in a twenty four unit packages The minimum order for any infant model ThermoWrap is twenty four u...

Страница 63: ...uage 1 200 00410 Accessory Kit with Adaptor Cables for Disposable Sensors 014 00028 Adaptor Cable for Disposable Core Temperature Probe Gray 1 014 00129 Adaptor Cable for Disposable Surface Temperatur...

Страница 64: ...usable Core Temperature Probe Adult Gray 014 00005 Reusable Core Temperature Probe Infant Gray 014 00021 Reusable Surface Temperature Probe Green 014 00322 Disposable Core Temperature Probe 20 pack 01...

Страница 65: ...ith authorized Belmont Medical Technologies representatives regarding the Allon system always state the model and serial numbers on the identification label located on the rear panel of the Allon devi...

Страница 66: ...ons through Allon Device for 30 minutes Staff As required by hospital clinic protocol Routine external cleaning and disinfecting Empty Allon For Frequent Use 3 4 times a week drain once a week For Inf...

Страница 67: ...ny saline or irrigated fluids Do not use any aggressive compound such as NaOH H2O2 Do not use any organic or ester solvents Always check the temperature probes for scratches frayed wires tears before...

Страница 68: ...residue removal use a new lint free cloth moistened with sterile water Use the cloth on the exterior of the system the LCD screen the power cord the reusable temperature probes1 and the hoses CAUTION...

Страница 69: ...manufacturer 8 Using a lint free cloth with the disinfectant disinfect the exterior of the machine the LCD screen the hoses the power cord and the reusable temperature probes1 NOTE Allow disinfectant...

Страница 70: ...The cleaning disinfecting and sterilization of the reusable temperature probes are according to the manufacturer s instruction WARNING Disposable probes are not to be reused Improper use can lead to c...

Страница 71: ...echnologies biomedical authorized personnel if needed more frequently than once a year according to water quality Annual checks should be performed every 12 months as described in the Service Manual S...

Страница 72: ...rming System Check verify that the water tank is full 1 In the Main menu select Services The following window appears 2 In the Services screen select System Check then click OK to confirm A message ap...

Страница 73: ...m Check is initiated The bar that appears on the screen indicates the progress System Check takes about 10 minutes When the process is complete a message appears on the screen SYSTEM CHECK COMPLETED 4...

Страница 74: ...ion is detected a fault message appears on the message display Should a malfunction occur consult the Troubleshooting Guide in Table 10 Table 11 and Table 12 Troubleshooting Guide Table 10 lists some...

Страница 75: ...ourse of the operation Turn off the Allon device and allow the water to return to the reservoir Replace the ThermoWrap if possible Water leaks from the connector between ThermoWrap and the connecting...

Страница 76: ...onnecting tube to the right Quick Coupling Connector under the Core Sensor socket The ThermoWrap cannot be connected when emptying 2 Connect the special male connector to the connecting tube See Figur...

Страница 77: ...s are not connected Connect connecting tubes Check for snarls folds or objects that obstruct the water flow in the wrap Check clamps The alarm can be muted for 10 minutes Connect Core Sensor No core t...

Страница 78: ...arls folds or objects that obstruct the water flow in the wrap Check clamps The alarm can be muted for 10 minutes Check Core Sensor Misplacement of core temperature probe in core socket Core temperatu...

Страница 79: ...ed for 10 minutes If the Surface temperature probe was incorrectly connected during operation the alarm can be muted for 10 minutes Low Core Temperature This message appears when Set Point Temperature...

Страница 80: ...is above XX X C The alarm for High patient s temperature can be configured in Settings The alarm and message are activated according to the selected alarm limit The available values range from 38 41 i...

Страница 81: ...shooting Guide Con t Message Cause of Problem Action to be taken Comments Out of Normothermia Range This appears when the operator chooses Set Point temperature for Normothermia 36 C or 38 0 C Touchin...

Страница 82: ...dditional user action If any of the above conditions is not fulfilled the operation panel message area displays technical and or clinical alarm messages with a sign NOTE Clinical Alarms represent Medi...

Страница 83: ...Technical Messages and Alarms Con t Message Message window Connect Core Sensor Check Water Tubes Check Core Sensor Check Surface Sensor Follow the instruction of the technical messages to solve the p...

Страница 84: ...irm the location of the core temperature probe and touch OK to continue The alarm can be muted for 10 minutes The alarm and message are activated according to the selected alarm limit Patient s temper...

Страница 85: ...ation stops during Safety Messages Safety messages indicate to the users that the system has either overcooled or overheated the circulating water Safety messages include WATER TEMP TOO LOW WATER TEMP...

Страница 86: ...indicate the status of the machine These messages are for information only and do not require any user action The message appears at the bottom of the Main Screen Informative messages include Out of...

Страница 87: ...flash This indicator will continue to flash for 10 minutes until power is restored or the Power Loss Alarm Disable button on the back of the unit is pressed Alarm Delay The following conditions genera...

Страница 88: ...ce to the Allon before the start of the medical procedure Belmont Medical Technologies recommends recording Allon device data for one patient at a time At the end of the procedure disconnect the Clini...

Страница 89: ...f 106 Figure 37 CliniLogger Initialization When initialization finishes the following screen appears 5 You can change the installation location by clicking Browse and selecting a new location Click Ne...

Страница 90: ...lmont Medical Technologies Page 90 of 106 Figure 39 CliniLogger Agreement 6 Select I accept the above 2 License Agreement s to accept the license agreements and click Next The Start Installation windo...

Страница 91: ...nologies Page 91 of 106 7 Click Next you can follow the installation progress in the progress bars until it finishes When the installation is finished the Installation Complete window appears Figure 4...

Страница 92: ...g Data You can download data from the CliniLogger Device to the CliniLogger Viewer Application on the PC To start the CliniLogger application 1 From the Windows Start menu click Programs CliniLogger 2...

Страница 93: ...pens 8 You can also click Convert to Excel to present the data in Excel format 9 Click Clear logger after saving the data to prepare the device for the next use NOTE You should erase the data on the C...

Страница 94: ...00 Rev C Belmont Medical Technologies Page 94 of 106 2 Click Load stored data and choose the file you would like to view When the data has been loaded the message appears Figure 45 CliniLogger Window...

Страница 95: ...cel CliniLogger Viewing Panel Start time and date SW Version The CliniLogger viewing panel includes the following data Start date and time received from the thermoregulation device Allon CritiCool Sof...

Страница 96: ...Graphic Display area consists of three parts Temperatures Graphs Set point Core and Surface as a function of time Modes and Error Area Thermoregulation modes Rewarming step and errors as a function of...

Страница 97: ...g between time zones and detailing the viewed data Temperature Graph Control Buttons These buttons define the shape of the curves in the temperature graphs area the water heat cool graph and the water...

Страница 98: ...e temperature graph area and grab the curve by pressing the mouse left button and moving the mouse Moving the mouse horizontally will move the graphs horizontally in time and moving the mouse vertical...

Страница 99: ...w limit line keep the left key pressed and pull horizontally to the end of the interesting time Once you release the mouse but ton the image is zoomed in Zoom in in the Y Temperature direction Use the...

Страница 100: ...at the cursor location appear inthe window adjacent to the curve color window 3 To bring cursor to the center of thegraph 1 Click Modes and Error Area This area provides the following information Sys...

Страница 101: ...Neonate P StandBy Q Select Mode Adult R Select Mode Neonate Functional Status Area Heat Cool and Pump On Power Off The graphs indicate the state of the wrap Heat Cool modes and the On Off of water cir...

Страница 102: ...to Excel 1 On the CliniLogger menu panel see in Figure 43 select Convert toExcel an Excel file opens with two options Measurement Table Sheet 1 Graphic Chart A second page in the Excel file shows a gr...

Страница 103: ...ech v1 6 3 from the CD to a location on the desired PC Run the CliniLogger tech exe application 28 28 5 29 29 5 30 30 5 31 31 5 32 32 5 33 33 5 34 34 5 35 35 5 36 36 5 37 37 5 2018 12 13 23 15 2 2018...

Страница 104: ...SERVICE REPRESENTATIVE WARNING The following details are necessary to contact your Belmont Medical Technologies representative Keep this form with the User s Manual for easy access for scheduling ann...

Страница 105: ...and CliniLogger are given in Table 17 Table 17 Separation Distances in Meters Separation Distance According to Frequency of Transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz...

Страница 106: ...ntended for use in the electromagnetic environment specified below The customer or the user of the Allon device should assure that it is used in such an environment Emissions test Compliance Electroma...

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