User Manual
Contents
1. 1 4 1 6 Labels 1 5 1 6 1 ALLON 2001 Device Labels 1 5 CHAPTER 2 2 1 System 2 1 2 1 General 2 1 2 2 22 5 ALLON 2008 Device 2 2 2 32 External Features eee 2 3 23 AFYON tern ete 2 3 2 3 2 Side View eese 2 4 2 3 3 Rear Pabel 2 5 2 5 2 949 ACCESS OLICS 2 5 0 3 5 Incl 3 5 3 1 Pre installation Requirements 3 5 3 1 1 Space and Environmental Requirements 3 5 3 1 2 Electrical 3 5 3 1 3 Unpacking and Inspection 3 5 3 1 4 Assembling the Handle 2 2 3 5 3 152 Equipment List 3 5 3 2 Moving 3 5 3 5 32 3 2 2 Locking and Unlocking the Trolley Wheels 3 5 3 3 Storage Conditions and 3 5 3 3 Li SOTR Beine seen EH HE HR MSN Ete 3 5 TABLE OF CONTENTS CHAPTER 4 4 5 Operating Instructions 0 2 4 5 Ae General extent ete ted tette D 4 5 4 2 Controls Indicators and 606010 4 5 4 2 1 Main Power 5 4 5 4 2 2 QCC Quick Coupling Connector2. 4 5 4 2 3 Sensor Sockets 4 5 4 3 Control Panel atitem e RODA 4 5 4 4 Preparing the System for 4 5 4 5 Procedures for Turning on the System 4 5 4 6 ENS TR 4 5 4 6 1 Self test Messages 4 5 4 7 Operating In Operation mode 0 4 5 4 8 Changing the Set Point 4 5 4 8 1 Exceeding the Normothermia 4 5 4 9 Selecting 4 4 5 4 10 astare CO E i Ra nes 4 5 4 10 1 Operation Mode sse 4 5 4 10 2 Temp Graph 4 5 2 4 5 4 10 4 Preference 4 5 4 11 Inserting and Attaching Human Sensors 4 5 4 11 1 Insert Core Sensor into 10 4 5 4 11 2 Attaching Surface 2 4 5 4 12 Fastening the Universal ThermoWrap to 4 5 4 13 Fastening Cardiac ThermoWrap to 4 5 4 14 Fastening Infant ThermoWrap to 4 5 4 15 Procedures for Turning Off the System and Moving the Patient to ICU with the 7 4 5 CHAPTER S svvsccenscccvaveseveresuaessvesdcveneversatecetaveseuevesasebenlaverenecsesnsesssaserkesdsavesdc
3. LIST OF FIGURES Figure 1 1 Label Placement for ALLON 2001 Device eere 1 5 Figure 2 1 23 1 6 2 2 51016 RAIL AD 2 4 2 5 2 5 2 5 25 25 Figure 3 1 3 5 Figure 4 1 Control Panel 0 4 5 Figure 4 2 Initial Self Test Screen 1 11 4 5 Figure 4 3 Self Test Preheating 4 5 Figure 4 4 Operation Mode 4 5 Figure 4 5 Out of Normothermia Message 4 5 Figure 4 6 Mode Selection Screen 4 5 Figure 4 7 Temp 4 5 asses 4 5 Figure 4 9 Preference Mode Screen 1 4 5 Figure 6 1 Filter Orientation 6 5 6 5 Figure 7 1 Connecting Tubes and Special Male Connector 1 eeeeeeeeeeeee 7 5 LIST OF TABLES Table 1 1 Key to Label 1 6 Table 2 5 Table 2 2 Universal 2 5 Table 2 3 2 5 Table 2 4 Sensor and Data Provider Input Specifications 2 5 Table 4 1 Key to Control Panel Symbols cete
4. THIS PAGE INTENTIONALLY LEFT BLANK 4 18 5 1 Equipment and Accessories Ordering Information 5 2 Equipment and Accessories Inventory 5 2 1 Available ThermoWraps CHAPTER 5 Ordering Information This section outlines information for ordering shipping and replacing parts of the ALLON 2001 system All equipment and accessories may be ordered directly from your local MTRE representative When ordering parts specify the model number as listed in this chapter as well as the serial number of your ALLON 2001 device ThermoWraps for adult models are packed in a twelve unit package that contains two six unit boxes each The minimum order for any model ThermoWrap is twelve units or any multiplication of twelve ThermoWraps for infant models are packed in a twenty four unit package The minimum order for any infant model ThermoWrap is twenty four units or any multiplication of twenty four 5 1 Ordering Information ALLON 2001 Table 5 1 Cardiac ThermoWraps Table of Cardiac ThermoWrap Sizes Model No Patient Height Range Quantity per box Models 3365 and 3368 may still be used Table 5 2 Universal ThermoWraps Table of Universal ThermoWrap Sizes Inches Feet amp Inches Centimeters 48 53 4 0 4 5 122 135 3153 53 60 4 5 5 0 135 152 3160 60 66 50 56 152 168 3166 66 71 56 511 168 180 ALLON 2001 Ordering Information Table 5 3 Infant ThermoWraps Tabl
5. 2001 device end and with two female Quick Coupling Connectors at the ThermoWrap end 2 13 System Description ALLON 2001 2 14 Male Connector for Draining Water Tank model no 4101 Refer to Section Table 7 1 on page 7 5 Spare Water Filter model no 4102 For annual filter replacement packed in the accessory box Handle model no 2100 ALLON 2001 System Description THIS PAGE INTENTIONALLY LEFT BLANK 2 15 3 1 Pre installation Requirements 3 1 1 Space and Environmental Requirements 3 1 2 Electrical Requirements CAUTION CHAPTER 3 Installation The ALLON 2001 device is supplied on a trolley as a mobile unit for user convenience It must be located no less than 5 cm 2 from other objects to avoid impairing ventilation to the ALLON 2001 device The following dimensions should be considered when placing the ALLON 2001 device 260 mm W 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H 120 230 VAC 500W Verify that the voltage switch is set for the local voltage Installation ALLON 2001 3 1 3 Unpacking and Inspection NOTE The ALLON 2001 device has undergone full quality assurance testing before shipment and should be operational upon delivery The unit should be unpacked installed and tested only by MTRE s authorized personnel No attempt should be made by the purchaser to unpack or assemble the unit alone Report any container dam
6. 7 Operating In Operation mode 4 8 After completing the self test the ALLON 2001 device shifts into operation mode A buzzer is sounded and an ATTENTION CORE READOUT TOO LOW message appears see Figure 4 4 Operation Mode The sensors read the room temperature until you position them on the patient and therefore the message appears When the core sensor is inserted in the patient the sensors read the patient s body temperature and the message clears Allon 2001 Figure 4 4 Operation Mode Screen ALLON 2001 Operating Instructions 4 8 Changing the Set Point Temperature The desired set point temperature should only be set by the physician or under the order of a physician WARNING Press the arrow key to decrease or increase the set point temperature The default temperature is 37 C 98 6 F When there is a difference between the set point temperature and the core temperature a further increase in the set point temperature will not affect the water temperature in the ThermoWrap For example if the core temperature is 36 C 96 8 F and the set point temperature is 37 C 98 6 F raising the set point temperature will not accelerate the heating of the water in the Allon 2001 system The Allon 2001 device automatically operates at the optimal level to obtain the desired set point temperature The default setting is intended to maintain normothermia However the system provides the physician wit
7. consequential damages Use of Manual The Allon 2001 system described in this manual has been designed to meet international safety and performance standards Only qualified personnel may operate the system and these operators must first have a full understanding of the proper operation of the system The purpose of this manual is to help qualified personnel understand and operate the system It is important that you read this manual and familiarize yourself thoroughly with its contents before you attempt to operate the system If you do not understand any part of this manual or if anything is unclear or ambiguous in any way please contact your MTRE representative for further clarification The information provided in this manual is not intended to replace regular medical training procedures This manual should always accompany the system qualified personnel operating the system should know the location of the manual For additional copies of this manual please contact your MTRE representative TABLE OF CONTENTS CHAPTER ecc 1 1 Safety Precautions DD E 1 1 ee ostii deti 1 1 1 2 Intended 1 1 sra d etse reete hat erae db eae e 1 1 1 4 01 2 1 3 1 92 Improper Use
8. eene ee eene eee enano 4 5 Table 5 1 Cardiac ThermoWraps 1 1 1 1 1 2 5 5 5 5 Table 5 3 Infant 5 5 Table 5 5 Table 6 1 Inspection and Maintenance 002 6 5 Table 7 1 Allon 2001 System Undisplayed Malfunction Troubleshooting Guide 7 5 Table 7 2 Allon 2001 System Message Troubleshooting Guide 7 5 vii 1 1 Definitions 1 2 Intended Use 1 3 Warnings CHAPTER 1 Safety Precautions WARNING indicates a condition that may endanger the patient or the system operator CAUTION indicates a condition that may damage the equipment NOTE indicates ways in which the system s operation can be made more efficient The ALLON 2001 system is designed to regulate body temperature as determined by the physician 1 physician must be notified if the patient s temperature does not respond properly does not reach the prescribed temperature or if there is any change in the prescribed temperature range Failure to inform the physician may result in injury to the patient The patient should be constantly attended by a physician 3 The misuse of the temperature regulation equipment can be potentially harmful to the patient 4 Donot plug wet PL plugs of the human sensors into the sensor sockets of the ALLON 2001 device 5 The use
9. see Table 7 1 on page 7 5 4 Insert the reusable core and surface sensors or the disposable core and surface adapters into the ALLON 2001 device sockets as described in section 2 3 5 on page 2 5 5 Connect the connecting tubes to the ALLON 2001 device 6 Choose the appropriate model and size ThermoWrap as described in section ThermoWrap Designs on page 2 5 Place it on the operating table as described in the leaflet enclosed with the ThermoWrap sections 1 and 2 7 Make sure to lie out the ThermoWrap evenly and avoid twisting or bending the tubes 8 Connect the ALLON 2001 device to the power source 4 4 ALLON 2001 Operating Instructions 4 5 Procedures for Turning on the System The patient must be under constant supervision The misuse of temperature regulation equipment can potentially injure a patient WARNING Turn the main switch located in the rear of the unit upwards to the ON position Once power is supplied to the ALLON 2001 device the unit performs a self test see section 4 6 Self Test 4 6 Self Test The self test is performed in order to ensure the proper functioning of the ALLON 2001 device see Figure 4 2 on page 4 5 A self test is conducted every time the system is restarted In the event of a power failure of less than 10 seconds the self test will not be performed and the ALLON 2001 device will remain in operation mode During the self test the PERFORMING SELFTEST PLEASE WAIT
10. to the parameters listed above If the patient s overall height or overall weight matches the minimum value of a specific model use the next smaller size XXX XXXcm x x Infant Weight Adult Height 2 9 System Description ALLON 2001 Table 2 1 Cardiac ThermoWraps Table of Cardiac ThermoWrap Sizes Model No Patient Height Range Quantity per box Models 3365 and 3368 may still be used Table 2 2 Universal ThermoWraps Table of Universal ThermoWrap Sizes Inches Feet amp Inches Centimeters 31 36 2 7 3 0 3148 48 53 4 0 4 5 122 135 53 60 4 5 5 0 135 152 3160 60 66 50 56 152 168 3166 66 71 56 511 168 180 2 10 ALLON 2001 System Description Table 2 3 Infant ThermoWraps Table of Infant ThermoWrap Sizes Model No Weight Range in kg Weight Range in Ib 3118 2 5 4 0 5 5 8 8 3121 4 0 7 0 8 8 15 4 3125 7 0 11 15 4 24 2 2 3 5 Accessories operate the ALLON 2001 system the following accessories needed 1 Human Temperature Sensors a Reusable Sensors There are three color coded sensors Core gray Surface green and Infant Core gray Both core and surface sensors must be plugged into the ALLON 2001 device The core sensor must be inserted and the surface sensor must be attached to the patient for the device to function properly b Disposable Sensors Disposable sensors are attached to two color coded ad
11. 2001 4 15 Procedures for Turning Off the System and Moving the Patient to ICU with the ThermoWrap 10 11 12 13 Operating Instructions Turn off the ALLON 2001 device by pressing the ON OFF switch downwards to the OFF position and disconnecting the power cord from the power source Close the clamps on the connecting tubes to avoid returning water overflow Disconnect the connecting tubes from the ALLON 2001 device and from the ThermoWrap Disconnect the core and surface sensors from the ALLON 2001 device If the patient is not transferred to the ICU with the ALLON 2001 system proceed to step 9 Place the sensors beside the patient Upon arrival to the ICU reconnect the sensors to the ALLON 2001 device Reconnect the connecting tubes to the ALLON 2001 device and the ThermoWrap Turn on the ALLON 2001 device to resume treatment At the end of treatment repeat steps 1 4 Remove the ThermoWrap and the sensors from the patient Dispose of the ThermoWrap in accordance with national regulations governing non toxic plastic waste discharge Disinfect the surface of the connecting tubes and the exterior of the ALLON 2001 device with a wet cloth soaked in 70 alcohol Dispose of disposable sensors or disinfect the reusable sensors and disposable sensor adapters as required by hospital clinic protocol Store the ALLON 2001 device and its accessories in a safe place Operating Instructions ALLON 2001
12. 4 Prior to moving the unit 1 Ensure that the ALLON 2001 device is off by pressing the ON OFF switch 2 Ensure that all electrical connections are disconnected The ALLON 2001 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 wheels lift the lever When the unit is stationary the brakes must be in the locked position Release the brakes only when transporting the unit Use protective means to avoid excessive vibration during device transport Store the ALLON 2001 device in a clean and dry area with a Anambient temperature of 40 C to 70 C 40 F to 158 F b Arelative humidity range of 10 to 100 c An atmospheric pressure range of 500 hPa to 1060 hPa The ALLON 2001 device features a utility bracket in the rear for storage of the connecting tubes and sensors when not in use 4 1 General 4 2 Controls Indicators and Connections 4 2 1 Power Switch 4 2 2 OCC Quick Coupling Connector CHAPTER 4 Operating Instructions This chapter contains description of the controls indicators and connections for the ALLON 2001 device e Detailed operating instructions for the ALLON 2001 system Included in this section is a short description of the following e Main power switch e QCC Quick Coupling Connectors e Sensor sockets e Control panel e I
13. 5900 Figure 1 1 Label Placement for the ALLON 2001 Device 1 5 Safety Precautions ALLON 2001 Table 1 1 Key to Label Symbols Symbol Description Location of core sensor socket Location of surface sensor socket AC Voltage Fuse CE mark of conformity indicates that the product has received the European approval for MDD 93 42 EEC Equipment not suitable in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Refer to user manual Type BF equipment Recycle Date of manufacture CSA symbol indicates that the product has received the approval of the Canadian Standards Association Machine Version Machine serial number 2 1 General Description CHAPTER 2 System Description The ALLON 2001 system maintains desired patient body temperature before during and after surgery The desired patient temperature is set by the surgeon and covers the normothermia to hypothermia range Most regular operations require normothermia This is achieved by heating to compensate for body heat losses resulting from redistribution due to the general anesthesia and from reduced metabolic rate and exposure of body organs and skin to the cold operating theatre environment The system is designed to maintain normothermia induce hypothermia and precise re warming The system is composed of two elements the A
14. ALLON 2001 THERMOREGULATION SYSTEM US ER 6 MANUAL Revised February 2010 cen Vi 6 6 0473 Conformity according to the Council Directive 93 42 EEC concerning Medical Devices Manufacturer s Name MTRE Advanced Technologies Ltd 4 Hayarden Street Yavne 8122804 P O Box 102 Rehovot 7610002 Israel Tel 972 8 9323333 Fax 972 8 93285 10 European Representative Charter Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes 1DT England Tel 01908 646070 Fax 01908 646030 US Representative Mennen Medical Corp 290 Andrews Road Feasterville Trevose PA 19053 3480 Phone 215 259 1020 Fax 215 357 2010 Publication No DDT 063 000 Rev A Revision February 2010 Copyright 2010 by MTRE All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders All rights reserved No part of this manual may be reproduced or copied in any form by any graphic electronic or mechanical means including photocopying scanning typing or information retrieval systems without advanced written permission from MTRE 0 5 Patent No 6 500 200 BI Disclaimer MTRE is not responsible for any consequential or incidental damages or expenses of any kind impairment of or damage to other goods or to any third party resulting from loss of use of the system caused by or due to the following a Installed operated maintain
15. E Allon 2001 Figure 4 9 Preference Mode Screen 4 14 ALLON 2001 Operating Instructions 4 11 Inserting and Attaching Human Sensors For proper use of the ALLON 2001 device the core sensor must be inserted and the surface sensor must be attached CAUTION 4 11 1 Insert Insert the reusable core sensor or the disposable core sensor as soon Core Sensor as possible into the patient prior to fastening the ThermoWrap into Patient Immediately connect the disposable core sensor to its adapter If core temperature reads less then 35 5 C the PATIENT TEMPERATURE BELOW 35 5C 95 9F message appears 4 11 2 Attaching Attach the reusable surface sensor or the disposable surface sensor Surface Sensor toan exposed area of skin with adhesive tape Immediately connect the disposable surface sensor to its adapter When using disposable sensors and adapters make sure to connect the appropriate sensor to its adapter note the labeling on the adapter WARNING Operating Instructions ALLON 2001 4 12 Fastening the Universal ThermoWrap to Patient 4 13 Fastening Cardiac ThermoWrap to Patient 4 14 Fastening Infant ThermoWrap to Patient 4 16 Refer to the Instructions for Use leaflet supplied with each ThermoWrap Refer to the Instructions for Use leaflet supplied with each ThermoWrap Refer to the Instructions for Use leaflet supplied with each ThermoWrap ALLON
16. LLON 2001 device and the ThermoWrap disposable garment The ALLON 2001 device performs the functions of heat pump water circulating pump and control unit The control unit constantly monitors the patient s core temperature through specific sensors and using its on board body temperature control algorithm decides on the optimum water temperature to reach the desired set point The heat pump brings the water to the required temperature and the pump circulates it to the garment The ThermoWrap garment is a flexible heat exchanger through which the water circulates It is designed to be in close contact with a large area of the body thus effecting good heat transfer with the body The garment designed to be disposable comes in a variety of styles and sizes to suit various types of operations and ages Access to virtually any part of the body for surgical procedure without seriously interrupting heat transfer is made possible by various flaps that are built into the design 2 1 System Description ALLON 2001 2 2 ALLON 2001 The ALLON 2001 system consists of the following elements e ALLON 2001 device e ThermoWrap e Accessories 2 2 1 ALLON 2001The ALLON 2001 device has a microprocessor that controls the Device water temperature flowing into the ThermoWrap worn by the patient The decision as to the correct water temperature is based on the desired set point temperature and the actual measured patient temperature core and su
17. N 2001 3 ThermoWrap Designs MTRE Advanced Technologies Ltd offers disposable ThermoWraps in a wide range of sizes There are three different ThermoWrap designs e Cardiac ThermoWrap used for e Universal ThermoWrap used for open heart surgery See Table 2 1 any typical surgery other than open on page 2 5 heart surgery For available sizes see Table 2 2 on page 2 5 Figure 2 4 Cardiac ThermoWrap Figure 2 5 Universal ThermoWrap e Universal Pediatric ThermoWrap e Infant ThermoWrap used for used for pediatric surgery For infant surgery For available sizes available sizes see Table 2 2 on page see Table 2 3 on page 2 5 2 5 Figure 2 6 Universal Pediatric ThermoWrap Figure 2 7 Infant ThermoWrap 2 8 ALLON 2001 System Description To determine the most suitable type of ThermoWrap for the procedure the following information is required Adult or infant e Adult height or infant weight see figures below e For adult type of operation to be performed cardiac or other A full range infant to adult is available with different models The model type model number and sizes are listed on the label on each package Choose the appropriate model and size according
18. N 2001 Device on page 1 5 When communicating regarding ThermoWraps refer to the label on the ThermoWrap package for lot number details The ALLON 2001 device should be periodically inspected and maintained to make sure that it remains in optimum condition A recommended routine inspection and maintenance schedule is provided in Table 6 1 Inspection and Maintenance Schedule on page 6 5 6 1 Maintenance ALLON 2001 6 4 Sterilization Use the Ethylene Oxide Method E T O to sterilize reusable sensors of Reusable and disposable sensor adapters as required by hospital clinic Sensors and protocol Disposable Sensor Adapters Do not use the steam autoclave method to sterilize reusable sensors and disposable sensor adapters CAUTION 6 5 Filter Replacement fm An additional filter is supplied the accessory box NOTE The filter must be replaced every twelve months Replacement is done by the hospital personnel as follows Drain the water tank see Table 7 1 on page 7 3 2 Remove the rear cover a Unscrew the thumb captive screws at the bottom of the cover b Pull the bottom part of the cover towards you and then down to release the lip from the chassis 3 Unscrew the filter clamp screw and remove the filter clamp see Figure 6 2 4 Release both the water in and water out tubes from the filter assembly by pressing the release ring of each end of the filter and pulling the t
19. RE e Reusable Surface Sensor model 4201 The surface sensor green measures body surface temperature when attached to the patient s skin The PL plug of the sensor cable is plugged into the green surface sensor socket at the front of the ALLON 2001 device The other end is attached with adhesives to the patient s skin 2 12 ALLON 2001 System Description e Disposable Surface Sensor Adapter model no 4203 The disposable sensor is attached to the surface sensor adapter green The PL plug of the adapter is plugged into the green surface sensor socket at the front of the ALLON 2001 device The sensor is attached with adhesives to the patient s skin and measures surface body temperature Table 2 4 Sensor and Data Provider Input Specifications Model Name Description Accuracy Resolution Type No 4200 Core Inner body 0 3 C 0 1 C Medical Grade temp Thermistor 4201 Surface Skin temp 0 3 0 1 Medical Grade Thermistor 4204 Core Infant Inner 0 3 C gt Medical Grade Infant body temp Thermistor 2 Detachable Electric Power Cable amp Plug See Table 5 4 Accessories Inventory on page 5 5 3 Connecting Tubes model no 4100 Two flexible 2 5m long connecting tubes connect the ThermoWrap with the ALLON 2001 device to enable the flow of water between them The tubes are supplied as a paired unit with two male Quick Coupling Connectors at the ALLON
20. TAND BY mode is used only to monitor body temperature see Mode Figure 4 8 The ALLON 2001 Device circulates the water internally and maintains the water temperature at the appropriate level to be ready when returning to OPERATION mode Allon 2001 Figure 4 8 Stand by Mode Screen fm ge During Stand by mode there is no temperature regulation NOTE fm When entering Temp Graph mode from Stand by mode the pP ALLON 2001 device returns to Stand by mode when pressing BACK To return to Operation mode press the MODE button again NOTE 4 13 Operating Instructions ALLON 2001 4 10 4 Preference PREFERENCE mode see Figure 4 9 enables the operator to Mode Select a language The Language preference allows you to change the language of the control panel interface Select temperature unit readout The Degrees preference allows you to select control panel units from either Centigrade or Fahrenheit The active settings are indicated with a star Selected items are highlighted 1 Select the desired preference language or temperature with the Arrow down button 2 Select the desired item with the Arrow right button When you move from one preference to the next the last item selected is the active setting and a star appears 3 Press EXIT at any time to return to OPERATION mode gt Access to Thermal Verification is for MTRE authorized NOT
21. TIONALLY LEFT BLANK 7 8 8 1 Physical 8 2 Control System CHAPTER 8 Specifications Dimensions 260 mm W 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H Net Weight 33 kg 77 lb Micro controller Operating icons Set point switch and mode switch Displays Surface Temperature Core Temperature Graphic display of core temperature Set point temperature Alarm displays Controller range Water Temperature outflow 13 40 8 C 55 105 4 F Set Point Temperature 30 40 86 104 F Sensors accuracy Patient Temperature 0 3 C 0 4 F Specifications ALLON 2001 8 3 Auxiliary Systems 8 4 Warranty 8 5 Operation 8 6 Storage and Transport 8 7 Electricity Water accuracy Water Temperature 0 3 C 0 4 F Water tank Maximum Volume 6 liters 1 6 gal One year Ambient Temperature 1090 4090 50 104 Control ALLON 2001 Device Maximum storage time is 26 weeks An ambient temperature range of 40 C to 70 C 40 F to 158 F Arelative humidity range of 10 to 100 An atmospheric pressure range of 500 hPa to 1060 hPa Temp range without water 40 C to 70 C 40 F to 158 F Input power 120 230 VAC with isolation transformer 50 60 Hz Maximum Current 120 230 VAC 6 3 amp Transformer Medical multiple isolation transformer 120 230 ALLON 2001 8 8 Safety Specificat
22. age prior to opening the container or any unit damage prior to unpacking installation or testing to your MTRE distributor 3 1 4 Assembling the Handle Assemble the handle as follows Release the four thumb captive 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 in the handle until the handle is inserted all the way in see Figure 3 1 3 Press in and screw the four thumb captive screws by hand do not use force when screwing to secure the handle and the top cover Thumb Screws Figure 3 1 Handle Assembly ALLON 2001 Installation 3 1 5 Equipment The ALLON 2001 system includes the following List e Allon 2001 device e Universal Cardiac Infant ThermoWraps ordered separately e Connecting tubes e Special connector for draining the water tank e Reusable core sensor for 230V system e Reusable surface sensor for 230V system e Reusable infant core sensor ordered separately for 230V system e Disposable core sensor adapter for 120V system e Disposable surface sensor adapter for 120V system e Handle e Spare Filter e Power cable e User manual e Quick Reference Guide 3 3 Installation ALLON 2001 3 2 Moving the Unit 3 2 1 Preparation 3 2 2 Locking and Unlocking the Trolley Wheels 3 3 Storage Conditions and Transport 3 3 1 Storage CAUTION 3
23. aining Water Tank gt Figure 7 1 Connecting Tubes and Special Male Connector A muted alarm is activated when a subsequent message appears 7 3 Troubleshooting ALLON 2001 The Halt Please Restart message indicates an error that can have numerous causes You must restart the ALLON 2001 device Table 7 2 Allon 2001 System Message Troubleshooting Guide Message Probable Cause Action to be Taken HALT PLEASE Error during normal Turn OFF the system for 3 seconds RESTART function and then turn it ON again If the problem persists turn OFF the c XX ALLON 2001 device and contact your local service representative Note the number that appears on the screen 1 16 ATTENTION No water in tank Refill water to maximum level NO WATER PLEASE ADD WATER Water tank float is Open water tank cap and insert a jammed long object to release the float ATTENTION Desired set point is set to e Approve the action OUT OF be out 061 0 NORMOTHERMIA e Disapprove the action PRESS OK TO CONFIRM Indicates alarm activated ALLON 2001 Troubleshooting Table 7 2 Allon 2001 System Message Troubleshooting Guide cont Message Probable Cause Action to be Taken ATTENTION Connecting tubes are not Connect connecting tubes CHECK connected THERMOWRAP 10 ThermoWrap is blocked due to improper wrapping ThermoWrap clamps are
24. apters Core gray and Surface green The core sensor must be inserted and the surface sensor must be attached to the patient for the device to function properly Sensors and adapters are guaranteed for one year Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400 compatible sensors WARNING System Description ALLON 2001 e Reusable Core Sensor model no 4200 The core sensor gray measures core body temperature when inserted into the patient s body The PL plug of the sensor cable is plugged into the gray core sensor socket at the front of the ALLON 2001 device The other end is inserted into the patient and measures core body temperature e Disposable Core Sensor Adapter model no 4202 The disposable sensor is attached to the core sensor adapter gray The PL plug of the adapter is plugged into the gray core sensor socket at the front of the ALLON 2001 Device The sensor is inserted into the patient and measures core body temperature e Reusable Infant Core Sensor model 4204 The infant core sensor gray measures infant core body temperature when inserted into the patient s body The PL plug of the sensor cable is plugged into the gray core sensor socket at the front of the ALLON 2001 device The other end is inserted into the patient and measures core body temperature Use only reusable surface sensors or disposable surface sensor adapters supplied by MT
25. ce garment with a one inflow and a one return water connection It is designed to facilitate the wrapping of individual parts of the body chest arms thighs etc to maximize surface coverage 2 Description and Intended Use e The ThermoWrap is Biocompatible Inflatable Adjustable Disposable Antistatic D D DO O DO Latex free e section of the ThermoWrap is separately wrapped around the appropriate area of the patient e g chest arms and thighs to ensure maximum body surface coverage water s exit and entrance points are short sections of tubing integrated with a Quick Coupling Connector QCC and welded to convenient locations on the edges of the ThermoWrap ThermoWrap design allows the physician to bare different body parts as dictated by surgical procedure e The ThermoWrap is available in a range of sizes and designs depending on surgery type to optimize body coverage e The ThermoWrap is secured to the patient via pressure sensitive adhesive strips that adhere to the garment The ThermoWrap can be secured to the patient s skin with medically approved peelable adhesive strips 2 6 ALLON 2001 System Description The Garments are defined for single patient use only Reusing may cause cross contamination and or irritation The Garments performances were validated only to defined WARNING usage time as defined in subsection 3 2 7 System Description ALLO
26. closed Check for snarls folds or objects that obstruct the water flow in the ThermoWrap Check clamps ATTENTION CHECK CORE SENSOR 1 Misplacement of sensor in core socket Connect the core sensor to the appropriate socket Core adapter is connected to the Allon2001 device without the disposable temperature sensor Connect disposable sensor ATTENTION Misplacement of sensor Connect the appropriate surface CHECK SURFACE in surface socket sensor to its socket SENSOR Surface adapter is Connect disposable sensor 12 connected to the Allon2001 device without the disposable temperature sensor ATTENTION No core sensor inserted in Connect core sensor CONNECT CORE its socket SENSOR Note In operation mode the water 0 temperature default setting is 38 5 C if the core sensor has not been inserted yet ED ndicates alarm activated The alarm is activated again after 30 minutes if no action is taken 7 5 Troubleshooting ALLON 2001 Table 7 2 Allon 2001 System Message Troubleshooting Guide cont 8 96 8 F e Core temperature is less then 32 C 89 6 F if set Message Probable Cause Action to be Taken ATTENTION Water Temperature Turn OFF the system for 3 WATER TEMP TOO lt 10 C seconds and then turn it ON LOW again If the problem persists turn OFF the ALLON 2001 16 device contact your local servic
27. course of the operation Connecting tubes are not connected properly Damage to connecting tubes to return to the reservoir Replace the ThermoWrap if possible Close clamps on ThermoWrap Disconnect connecting tubes and re connect connecting tubes until the click sound is heard Replace connecting tubes Damage to Quick Coupling Connector Call BMD Water leaks between connecting tubes and the Allon 2001 device Connecting tubes are not connected properly Disconnect connecting tubes from the machine and re connect again Damage to connecting tubes Replace connecting tubes Damage to Quick coupling connector Call BMD 7 2 ALLON 2001 Troubleshooting Table 7 1 Allon 2001 System Undisplayed Malfunction Troubleshooting Guide cont Observation Action to be Taken Water tank If it is necessary to drain the water tank because of overfilling proceed overfilled as follows 1 Connect one connecting tube to the right Quick Coupling Connector under the Core Sensor socket but not to a ThermoWrap 2 Connect the special male connector model no 4101 to the connecting tube see Figure 7 1 in Step 1 Turn the Allon 2001 device ON Change into Operation mode Allow the excess water to drain into a receptacle pail or sink v De 19 When the desired water level has been reached turn the ALLON 2001 device OFF Special Male Connector for Dr
28. e of Infant ThermoWrap Sizes Model No Weight Range in kg Weight Range in Ib 3118 2 5 4 0 5 5 8 8 3121 4 0 7 0 8 8 15 4 3125 7 0 11 15 4 24 2 Table 5 4 Accessories Inventory Allon 2001 Unit Model No Description 2100 Handle 4100 Connecting tubes 4101 Male connector for draining water tank 4102 Spare water filter 4200 Core sensor Gray 4201 Surface sensor Green 4202 Core sensor adapter Gray 4203 Surface sensor adapter Green 4204 Infant Core sensor Gray 4300 Hospital Grade Power Cable European standard 4301 Hospital Grade Power Cable UK standard 4302 Hospital Grade Power Cable USA standard Ordering Information ALLON 2001 THIS PAGE INTENTIONALLY LEFT BLANK 5 4 6 1 Introduction WARNING 6 2 Service Information 6 3 Routine Maintenance CHAPTER 6 Maintenance This chapter outlines the maintenance instructions for the ALLON 2001 system Qualified hospital staff may perform routine maintenance unless otherwise specified The repair and servicing of the Allon 2001 system should be performed only by MTRE Advanced Technologies LTD or authorized agents of MTRE Advanced Technologies LTD When communicating with authorized MTRE representatives regarding the ALLON 2001 system always state the model and serial numbers on the identification label located on the rear panel of the ALLON 2001 device see Figure 1 1 Label Placement for the ALLO
29. e representative ATTENTION Water Temperature Turn OFF the system for 3 WATER TEMP gt 42 seconds and then turn it ON TOO HIGH again If the problem persists turn OFF the ALLON 2001 17 device and contact your local service representative ATTENTION e Core temperature is less Insert the core sensor into CORE READOUT then 27 0 C 80 6 F if patient TOO LOW set point above 36 C point is below 36 C 96 8 F PATIENT TEMP Core temperature reading Inform the physician ABOVE 38 5 C above 38 C 101 3 F 101 3 F PATIENT TEMP Core temperature is higher Inform the physician BELOW 35 5 C than 27 0 C 80 6 F 95 9 F ED Indicates alarm activated Pressing Alarm Mute silences the buzzer for this present condition and any reoccurrence of this condition for thirty minutes 7 6 ALLON 2001 Troubleshooting Table 7 2 Allon 2001 System Message Troubleshooting Guide cont CONNECT SURFACE into the socket Message Probable Cause Action to be Taken ATTENTION The ALLON 2001 device The message will disappear ELECTRO MAGNETIC detects an electromagnetic after ten seconds INTERFERENCE field greater than allowable standard If the message appears for 22 more then ten seconds replace the core sensor ATTENTION No surface sensor inserted Connect surface sensor to its socket SENSOR 7 7 Troubleshooting ALLON 2001 THIS PAGE INTEN
30. e training program prior to using the ALLON 2001 system is mandatory The repair calibration and servicing of the ALLON 2001 system should be performed only by MTRE Advanced Technologies LTD or authorized agents of MTRE Advanced Technologies LTD ALLON 2001 1 4 Precautions Safety Precautions Follow the warning notes listed in the various sections of this manual Only trained personnel familiar with all system operating procedures and certified only by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd are allowed to use the ALLON 2001 system All hospital personnel using the ALLON 2001 system must complete the ALLON 2001 training program The repair and servicing of the ALLON 2001 device should be performed only by qualified medical equipment service technicians certified by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd If moisture or leaks are discovered in the connecting hose and or ThermoWrap turn off the ALLON 2001 device disconnect the power cable from its power source and correct the problem before proceeding The desired set point temperature should be fixed only as prescribed by and under the order of a physician If the device sounds an alarm and or presents a display other than the standard MTRE display the operator should proceed according to the display message and or the troubleshooting instructions see Chapter 7 Trouble
31. eatessueresesta 5 5 Ordering MOP MAGO 5 5 5 1 Equipment and Accessories Ordering 1010111810 5 5 5 2 Equipment and Accessories 5 5 5 2 1 Available 5 5 TABLE OF CONTENTS CHAPTER 6 6 5 covecssedeueeteoseuteceeseossees csveneceereoueses 6 5 6 1 Introduction A aida 6 5 6 2 Service Information 1 nde iie P aea ded 6 5 6 5 6 4 Sterilization of Reusable Sensors and Disposable Sensor Adapters 6 5 6 5 Filter Replacement 6 5 M M 7 5 7 7 5 7 5 7 2 Trouble shooting 7 5 8 P M 8 5 2 8 5 8 5 8 2 Control api 8 5 8 3 Auxiliary Systems 8 5 844 i eE E EERE EEE ETE ere ore E ERER 8 5 8 5 9 8 5 827 100 0 8 5 8 5 Sadlety m oL UM E NP PUT Det 8 5 8 0 ACCESSOFIOS s RC e Pe e ee e ER a eee eee e e eed 8 5 52252555252 545 04 6666 60800066060 0 04600666668 8 10 0600 8 06 006040660666 a osas 5 A 5
32. ed contrary to MTRE s instructions notes or warnings under this manual b Misuse unauthorized use negligence accident including fire water explosion smoke vandalism etc c Ignoring any of the warnings precautions and safety measures indicated in this manual d Replace repair or alter not by MTRE s authorized personnel e Anyone other than MTRE s authorized and certified personnel removes casing and or attempts to make or makes any internal changes removals attachments or additions to the 2001 System or components thereof f The power supplied to the System or any part thereof differs from the rated value or any external device attached by user creates conditions exceeding the tolerance of the System g 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 the MTRE h 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 i Failure to replace the ThermoWrap in each procedure while operating the system Note that all ThermoWraps are one use disposable materials and should not be reused j Force Majeure In no event shall MTRE be liable for loss of use loss of profits or other collateral special or
33. er through each operational phase Heating Cooling Status _ System Function Status Heat transfer to from patient Temperature Set point Core Temperature Surface Temperature Figure 4 1 Control Panel Table 4 1 Key to Control Panel Symbols Symbol Description Explanation Heat transfer Graphical representation of the intensity of heat to from patient transferred between the patient and the Allon system Heating Cooling Indicates the direction of the heat transfer 21 Status e Sunicon Heat transferred to the patient Mc e Snowflake icon Heat transferred from the patient HH System Function Indicates the condition of the pump If the icon is not Status displayed the pump is not functioning and water does not flow to the ThermoWrap 4 3 Operating Instructions ALLON 2001 4 4 Preparing the 1 Place the unit in the desired position according to section System for 3 1 1 Space and Environmental Requirements Operation on page 3 5 Do not place the ALLON 2001 device under the operating table or patient s bed CAUTION 2 Press the brake pedals and lock the wheels to secure the ALLON 2001 device 3 Remove the water tank feeder cover and pour in tap water until the maximum allowable level is reached Observe the water level indicator to prevent overfilling the water tank Close the water tank feeder cover In case of overfilling
34. f the Allon 2001 system 6 4 7 1 General 7 2 Trouble shooting Guide WARNING CHAPTER 7 Troubleshooting The Allon 2001 device is equipped with self testing routines that continuously monitor system operation Ifa system fault or malfunction is detected a fault message appears on the message display Should a malfunction occur consult the Troubleshooting Guide in Table 7 1 and Table 7 2 of this chapter Table 7 1 lists some possible symptoms that indicate malfunctions that do not appear on the message display their cause and recommended actions Table 7 2 provides a list of fault messages that appear on the ALLON 2001 device screen The repair and servicing of the ALLON 2001 system should be performed only by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd Troubleshooting ALLON 2001 Table 7 1 Allon 2001 System Undisplayed Malfunction Troubleshooting Guide Observation Possible Problem Action to be Taken The power switch of the Allon 2001 device is set to ON but it is not activated ALLON 2001 device is unplugged Check the 120 230 VAC power cable connections and the control panel is No line voltage Call BMD blank ThermoWrap begins to The garment was Turn off the ALLON 2001 leak accidentally punctured device and allow the water Water leaks from the connector between ThermoWrap and the connecting tube during the
35. h the option of selecting a body temperature in the range of 30 C to 40 C 86 F 104 F WARNING 4 9 Operating Instructions ALLON 2001 4 8 1 Exceeding If the desired set point temperature is set to be out of the normothermia range 36 38 96 8 F 100 4 F the ATTENTION OUT OF NORMOTHERMIA PRESS OK TO CONFIRM message appears see Figure 4 5 Normothermia Range Press OK to confirm Allon 2001 Figure 4 5 Out of Normothermia Message 4 10 ALLON 2001 Operating Instructions 4 9 Selecting 1 Press the MODE key Modes 2 Use the Arrow keys to select the desired mode 3 Press the ENTER key to enter the desired mode Allon 2001 Figure 4 6 Mode Selection Screen Operating Instructions ALLON 2001 4 10 Modes 4 10 1 Operation OPERATION mode enables the operator to go directly to the Mode operation mode see Figure 4 4 on page 4 5 4 10 2 Temp TEMP GRAPH mode displays a graphic readout of the patient s Graph Mode Core temperature on an hourly scale see Figure 4 7 e Upto eleven hours are stored in memory and be viewed by pressing the arrow keys to scroll back or forward on the graph e Both Core and Surface temperatures are displayed in real time at the top of the screen e To return to OPERATION mode press BACK Allon 2001 Figure 4 7 Temp Graph Mode 4 12 ALLON 2001 Operating Instructions 4 10 3 Stand by S
36. ions Warning displays indicates audible alarm PRESS Oo CD oo ovo DO ATTEN ATTEN ATTEN ATTEN ATTEN ATTEN ATTEN ATTEN ATTEN ATTEN 101 3 F 95 9 F ATTEN SYSTEM HALT TION PLEASE ADD WATER TION OUT NORMOTHERMIA RANGE OK T O CONFIRM TION CHECK THERMOWRAP TION CHECK CORE SENSOR TION CHECK SURFACE SENSOR TION CONNECT CORE SENSOR TION WATER TEMP TOO LOW 2 TION WATER TEMP TOO HIGH TION CORE READOUT TOO LOW TION PATIENT TEMPERATURE ABOVE 38 5 C TION PATIENT TEMPERATURE BELOW 35 5 C TION ELECTROMAGNETIC INTERFERENCE ATTENTION CONNECT SURFACE SENSOR Protection against electric shock Type BF Degree of protection against electric shock Class 1 Specifications ALLON 2001 8 9 Accessories Special mechanism Prevents extremely high pressure and temperature Quick coupling connectors Prevent leakage Anti current overload system 6 3 amp fuse ALLON 2001 device shutdown mechanism Software failure 9 9 9 9 Connecting tubes Connector for draining the water tank Power cable Spare filter Sensors 14 PL Stereo Phone Plug 9 9 9 Reusable core Reusable surface Reusable infant core Disposable adapter core Disposable adapter surface ThermoWrap 9 9 9 Various ThermoWrap types Sizes
37. message appears until the system is ready see Figure 4 2 on page 4 5 Whenever the Allon 2001 device is activated complete self test must be performed Do not interrupt the self test and wait until the ALLON 2001 device shifts into operation mode NOTE 4 5 Operating Instructions ALLON 2001 The self test performs a complete check of the system and initiates heating The time required for the self test is indicated both by the progress bar and by the message on the control panel The self test checks the functionality of the following components Screen and buzzer Pump ThermoWrap connection Pressure meter Heating and Cooling unit Temperature of water inflow and water outflow Successful completion of the self test indicates that the ALLON 2001 device is operational Allon 2001 Figure 4 2 Initial Self Test Screen 4 6 ALLON 2001 Operating Instructions Allon 2001 Figure 4 3 Self Test Preheating Message 4 6 1 Self test If there is a failure during the self test messages appear and the Messages ALLON 2001 device does not proceed to operation mode See Chapter 7 Troubleshooting for details Some of the messages will halt the ALLON 2001 device Other messages allow the completion of the self test but display the actions you need to take to correct the error See Chapter 7 Troubleshooting 4 7 Operating Instructions ALLON 2001 4
38. ndicators e Displays The main power switch located on the rear side of the unit switches the ALLON 2001 device ON and OFF The Quick Coupling Connectors are located at the front of the ALLON 2001 device and are connected to the ThermoWrap by means of the connecting tubes 1 Connecting the Connecting Tubes Lock the connecting tubes by pressing them against the connectors When locked a clicking sound is produced Verify that the tubes have been locked by lightly tugging them towards you 2 Disconnecting the Connecting Tubes Press the metal flange and pull out the connecting tubes 4 1 Operating Instructions ALLON 2001 4 2 3 Sensor There are two sensor sockets located in the front of the ALLON Sockets 2001 device 1 Connecting the Sensors Insert the appropriate reusable sensor or disposable sensor adapter into the designated socket When using disposable adapters you must connect the adapter to the disposable sensor before you insert the connector into the designated socket 2 Disconnecting the Sensor Pull the appropriate reusable sensor or disposable adapter out of its socket 4 2 ALLON 2001 Operating Instructions 4 3 Control Panel The adjustable control panel is located at the top of the ALLON 2001 device Once the ALLON 2001 device is turned on all operating functions are controlled through the control panel The control panel s simple soft touch keys and visual displays guide the us
39. r should verify that no fluids are present at the skin ThermoWrap interface during the operation Failure to do so can cause lesions on the patient s skin Following the procedure a pattern resembling the ThermoWrap may appear for a short period of time on the patient s skin 6 Inoperations that usually extend over two hours pressure sores may appear or develop when soft tissue is compressed between a bony prominence and external surface The use of the Allon 2001 system does not prevent this occurrence It is therefore recommended to use pressure sores protective means between the operating table and the ThermoWrap 1 1 Safety Precautions ALLON 2001 10 11 12 Before initiating maintenance procedures as described in Chapter 6 disconnect the power cord from the power source 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 of 30 C to 40 C 86 F 104 F Do not lift or move the patient by means of the ThermoWrap This may cause tearing and water leakage Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400 compatible sensors The technical principles clinical applications and risks associated with circulatory support must be thoroughly understood before using this product Read the entire manual before attempting to activate the system Completion of th
40. range from 40 cm 196 cm 1 4 6 5 Humidity level range 10 90 Maximum shelf lifetime of three years Appendix A MTRE Customer Service Representative Important The following details are necessary to contact your MTRE representative Keep this form with the User s Manual for easy access in case your Allon 2001 device is in need of service Representative Name Company Name Address Telephone No Fax E mail
41. rface Water pressure in the ThermoWrap is regulated by timed pauses of the flow during clinical operation The ALLON 2001 device is equipped with a handle for easy transport 2 2 ALLON 2001 2 3 External Features 2 3 1 Front View System Description Adjustable Control Panel Core Sensor Socket Socket BA 6 8 Water in Quick Coupling Connector Water Tank Cap Water out Quick Coupling Connector Water Level Indicator Bn Figure 2 1 Front View System Description ALLON 2001 2 3 2 Side View Top Cover with Air Outlet Grille Accessories Bracket Lower Side Cover Air Inlet Grille Figure 2 2 Side View ALLON 2001 2 3 3 Rear Panel Three prong Connector RS 232 Comm Connector System Description Thumb Screws 4 Air Outlet Grille 6mm Threaded Hole for Equipotentiality Location Figure 2 3 Rear View 2 5 System Description ALLON 2001 2 3 4 ThermoWrap 1 General The ThermoWrap is a one pie
42. shooting Avoid folds in the ThermoWrap these may obstruct water flow Do not block the ALLON 2001 device ventilation grilles Air must be able to flow freely in and out in order to keep the device cool Do not use de ionized or distilled water Use tap water only When X ray imaging is performed on a patient wearing a ThermoWrap shadows from the ThermoWrap may appear on the X ray film Avoid inserting any sharp object between the patient and the ThermoWrap 1 3 Safety Precautions ALLON 2001 1 5 Improper Use WARNING CAUTION Improper use of the ALLON 2001 system may lead to skin lesions electrical hazards and severe changes in body temperature The technical principles clinical applications and risks associated with circulatory support must be thoroughly understood before using this product Read the entire manual before attempting to activate the system Completion of the training program prior to using the ALLON 2001 system is mandatory U S Federal law restricts this device to sale by or on the order of a physician ALLON 2001 1 6 Labels 1 6 1 ALLON 2001 Device Labels Safety Precautions Allon 2001 MTRE Advanced Technologies Ltd 4 Ha Yarden st Yavne 81228 PO Box 102 Rehovot Israel www mire com P N 100 0000X Serial No XX XXXX 230V 115V 50 60Hz 500W 4 2x6 3A T 250V Mfg 2007 us COAT Complies With 21 CFR 870
43. ubes from the filter 5 Dispose of the old filter ALLON 2001 Maintenance To replace the filter assembly follow the procedure listed below The filter is marked with an arrow indicating the direction of water flow see Figure 6 1 You must assemble the filter in the manner indicated CAUTION 1 Connect the tubes to the new filter assembly Insert both tubes with suitable force to ensure that they are secure 2 Position the filter clamp in the chassis and tighten the filter clamp screw by hand see Figure 6 2 3 Close the rear cover and tighten the thumb captive screws by hand CI Filter Clamp Screw Figure 6 1 Filter Orientation Figure 6 2 Filter Assembly Maintenance ALLON 2001 Table 6 1 Inspection and Maintenance Schedule Frequency Inspection Service Performed By Before each treatment e Clean connecting tubes and Staff Quick Coupling Connector with a wet cloth e Perform a visual inspection for any mechanical failure in sensors connecting tubes and power cable e Perform a visual inspection of the exterior of the ALLON 2001 Device As required by Routine external cleaning and Staff hospital clinic protocol disinfection Annually Calibration check BMD Replace filter Staff The ThermoWrap contains chlorine tablets that prevent contamination of the hydraulic system o
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