Operator`s Manual
Contents
1. 0 00 eee eee 15 Section 7 0 Maintenance 000 ccc eee eee eee 16 Section 8 0 Storage ais ote a ed eke eee et eed or eds 16 Section 9 0 Return Policy 0 cece eee eee eee 16 Section 10 0 Troubleshooting Guide 1 2 22 eee eee 19 Section 11 0 Technical Data lt seesi sersut sari mae eee 20 Section 11 1 Environmental Conditions that Affect Use 20 Section 11 2 Classification orase sdn in r eee 20 Section 11 3 Accessories 0 0 06 eects 20 Section 11 4 Electromagnetic Emissions Immunity 20 Figures amp Tables Figure 1 Wire in Sheath 00 cece eee eee eee eae 4 Figure 2 TubeClear Component Locations s ssas seser eee ee eee 6 Figure 3 Collar and Stem Lock Locations 0 00 0eeeeeeeeee 7 Figure 4 Removal of Plastic Cap from Magnet Adapter 8 Figure 5 Attachment of Magnet Adapter to Diaphragm 9 Figure 6A Correct Placement of Stem Lock in Bracket Adapter 10 Figure 6B Incorrect Placement of Stem Lock in Bracket Adapter 10 Figure 7A Correct Handling of Clearing Stem 0 eee eee eee ee 10 Figure 7B Incorrect Handling of Clearing Stem 0 00 eee eee 10 Figure 8 Insertion of Clearing Stem into Nasogastric Tube 12 Figure 9 Collar Limits Insertion of Clearing Stem 0 002 00 eee 14 Flow Diagram Part A Diagram for Operation of TubeC2. 1 Power Cord Plugs into a standard three prong outlet and into the Power Supply Power Supply Cord Plugs into the Jack on the Control Box Control Box Contains the Motor and drive electronics Green Indicator Light Indicates power is available and is ready to start Yellow Indicator Indicates an electrical fault TubeClear Light will not operate when the yellow light is on i i l Diaphragm Clearing Stem attachment point tdk Stem Lock Fits within the Bracket Adapter secures the Clearing Stem Bracket Adapter Holds and positions the Clearing Stem during use Feature limits insertion depth of the Clearing Stem Plastic Cap Covers and protects Magnet Adapter during storage Diaphragm Ring Feature to secure Diaphragm to Control Box Stem Label Describes Model and intended nasogastric tube 5 ActuatedMedical com FIGURE 2 TubeClear Component Locations 5 CONTROL BOX 6 ON OFF POWER SWITCH 4 JACK 3 POWER SUPPLY CORD 2 POWER SUPPLY 8 START STOP BUTTON 6 ON OFF POWER SWITCH 21 DIAPHRAGM RING 10 DIAPHRAGM COVER not shown 11 DIAPHRAGM 15 BRACKET ADAPTER S 23 STEM LABEL i 22 STRAIN RELIEF not shown 13 STEM LOCK 7 9 INDICATOR LIGHTS 14 MAGNET ADAPTER 24 MAGNET not shown refer to Fig 4 16 SHEATH 19 PLASTIC CAP not shown refer to Fig 4 TubeClear Operator s Manual 6 4 0 Set up Instructions 4 1 4
3. AN Turn off and unplug the Control Box 5 prior to cleaning AN Thoroughly clean the Control Box 5 after each use 6 1 To clean the Control Box 5 use 1 a nonabrasive cloth dampened with isopropyl alcohol or 2 disinfectant wipes Wipe over exterior surfaces 6 2 To clean the Diaphragm 11 use 1 a nonabrasive cloth dampened with isopropyl alcohol or 2 disinfectant wipes Carefully wipe over the surface 6 3 Do NOT clean the Clearing Stem 12 The Clearing Stem is designed for SINGLE USE It should not be reused under ANY condition Dispose of the Clearing Stem in the Packaging as regulated medical waste in accordance with applicable government regulations and your Institution s Protocol 15 ActuatedMedical com 7 0 Maintenance Other than careful cleaning of the Control Box after each use TubeClear does not require maintenance 8 0 Storage Store the Control Box 5 and any unused Clearing Stems in a clean dry area It is recommended that the Control Box and Clearing Stems be stored at temperatures between 32 F to 95 F 0 C to 35 C and at a relative humidity less than 60 9 0 Return Policy Actuated Medical Inc AMI takes pride in the quality of our products If you are not satisfied with our products or if the TubeClear Control Box stops working within twelve 12 months from the initial date of shipment contact our Customer Service Department at 814 355 0003 ext 100 for a prompt repla
4. 1 0 3689 0 3689 0 7383 1 1 1666 1 1666 2 3333 10 3 6893 3 6893 7 3786 100 11 6666 11 6666 23 3333 TubeClear Control Box Model 101 is intended for use in the electromagnetic environment in which radiated disturbances are controlled The Operator of TubeClear Control Box Model 101 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and TubeClear Control Box Model 101 as recommended above according to the maximum output power of the communications equipment TubeClear Operator s Manual 24
5. 5 13 5 30 The clog may be particularly difficult to clear or functioning of TubeClear and increased emissions or there may be multiple clogs throughout the nasogastric tube decreased immunity of TubeClear If movement of the Wire is blocked due to clog material a being in the Sheath replace the Clearing Stem with a new 11 4 Electromagnetic Emissions Immunity Stem and repeat from Section 5 0 Steps 5 14 5 37 Guidance regarding electromagnetic emissions and The Clearing Stem Sheath may have become packed with EE EA Hele ui in Table 3 clog materials If the Clearing Stem appears to be damaged able 4 lable 9 and lable 0 replace with a new Clearing Stem and try again Use less force and allow the Clearing Stem to do the work 19 ActuatedMedical com TubeClear Operator s Manual 20 TABLE 3 Guidance amp Manufacturer s Declaration Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 TubeClear Control Box Model 101 uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions Class A IEC 61000 3 2 TubeClear Control Box Model 101 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used fo
6. the Clearing Stem or any de clogged contents from the nasogastric tube with ordinary waste Dispose as regulated medical waste in accordance with applicable government regulations and your Institution s Protocol The TubeClear Clearing Stems are SINGLE USE 3 0 Device Description Operator Profile TubeClear is intended for use by licensed practical nurses LPNs registered nurses RNs or physicians TubeClear is a device for clearing clogs in nasogastric NG tubes while the tube REMAINS in the Patient TubeClear consists of a reusable Control Box and a single use Clearing Stem The Clearing Stem magnetically attaches to the Control Box Clogs are occlusions blockages or obstructions of feeding formula medications supplements or aspirated contents in the nasogastric tube The Clearing Stem consists of an 80 in 203 cm long flexible Wire encased in a flexible Sheath The outer diameter of the Wire is approximately 1 32 in 0 07 cm and the outer diameter of the Sheath is approximately 1 16 in 0 17 cm The tip of the Wire is rounded and smooth The tip extends approximately 1 in 2 54 cm beyond the Sheath The Control Box contains a Motor that activates the Clearing Stem Wire The Motor causes the Wire to move quickly forward and backward inside the Sheath The Wire moves approximately 1 8 3 ActuatedMedical com FIGURE 1 Wire in Sheath The Wire moves forward and backward insid
7. 1 test level Conducted EN IEC 61000 4 6 Radiated RF EN IEC 61000 4 3 1 3Vms 150 kHz 80 MHz 3V m 80 MHz 2 5 GHz Compliance level 3 Vms 3 V m Electromagnetic Environment Guidance Portable and mobile communications equipment should be separated from TubeClear Control Box Model 101 by no less than the distances calculated listed below D 3 5 V 1 Sqrt P D 3 5 E1 Sqrt P 80 800 MHz D 7 E1 Sqrt P 800 MHz 2 5 GHz Where P is the max power in watts and D is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels V1 and E1 Interference may occur in the vicinity of equipment containing a transmitter TubeClear Control Box Model 107 is intended for use in the electromagnetic environment specified above The Operator of TubeClear Control Box Model 101 should assure that it is used in such an environment ActuatedMedical com TABLE 6 Recommended Separation Distances for TubeClear Control Box Model 101 Separation m p Separation i Separation m 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz D 3 5 V1 Sqrt P D 3 5 E1 Sqrt P D 7 E1 Sqrt P 0 01 0 1166 0 1166 0 2333 0
8. 1 2 Contraindications TubeClear is NOT intended for use in jejunostomy tubes J tubes percutaneous endoscopic gastronomy tubes PEG tubes gastrostomy jejunostomy tubes GJ tubes or nasojejunal tubes NJ tubes Do NOT use TubeClear if You are NOT certain that the Patient has a nasogastric NG tube You do NOT know for certain the size and length of the Patient s nasogastric tube The TubeClear Clearing Stem model is NOT available for the size and length of the Patient s nasogastric tube The nasogastric tube has been removed from the Patient The Patient is less than 18 years old The nasogastric tube requires placement or repositioning 1 ActuatedMedical com 2 0 Cautions Read the entire manual before using TubeClear Disregarding the cautions and instructions presented in this manual constitutes ABNORMAL USE Over insertion of the TubeClear Clearing Stem may cause harm to the Patient s stomach lining Take care to make certain that the correct Clearing Stem model has been selected for the size and length of the Patient s nasogastric tube Refer to Section 5 0 Operating Instructions for guidance on verifying correct selection of the Clearing Stem If the nasogastric tube is removed do NOT clear and re insert the same nasogastric tube TubeClear is intended to be used with the nasogastric tube residing IN THE PATIENT If the nasogastric tube has been removed from the Patient follo
9. 2 4 3 4 4 4 5 4 6 4 7 4 8 Verify that you have the correct TubeClear Clearing Stem model for the size of nasogastric tube Refer to Table 1 in Section 5 0 for model selection Place the Control Box on a level table to reduce the risk of the Control Box falling NOTE It may be helpful to reference Figure 2 when reading through the Set up Instructions Verify that the Power Cord 1 is securely plugged into the Power Supply 2 Plug the Power Cord 1 into a standard 100 240 V 50 60 Hz three prong outlet Plug the Power Supply Cord 3 into the Jack 4 on the Control Box 5 Verify that the Control Box 5 is operational by turning the On Off Power Switch 6 to the ON position The Green Indicator Light 7 will illuminate when the Control Box 5 is operational NOTE The Control Box Motor will not start at this time The Start Stop Button 8 needs to be pushed down before the Control Box Motor will operate FIGURE 3 The Collar and Stem Lock Locations 13 STEM LOCK ActuatedMedical com 4 9 If the Yellow Indicator Light 9 illuminates do NOT use the Control Box 5 Turn the power off and then back on cycle the power If the Yellow Indicator Light remains on see Section 9 0 Return Policy 4 10 Remove the Diaphragm Cover 10 from the Diaphragm 11 4 11 Remove the Clearing Stem 12 from its Packaging Do NOT discard the Packaging 4 12 Veri
10. 3 Tube Operator s Manual Read this Manual before using TubeClear Failure to follow the cautions and instructions in this Manual constitutes abnormal use and can result in injury For use with TubeClear Control Box Model 101 and Clearing Stem Models NG 1043 and NG 1036 ACTUATED Innovative motion Positive outcomes KIMAL PLC EC REP Arundel Road Uxbridge Middlesex UB8 2SA U K 2012 Actuated Medical Inc 310 Rolling Ridge Drive Bellefonte PA 16823 USA DOC ECO1219 PATENT PENDING Operator Assistance Information If you have questions regarding the use of TubeClear please contact Customer Service Department at Actuated Medical Inc 310 Rolling Ridge Drive Bellefonte PA 16823 Phone 814 355 0003 ext 100 Fax 814 355 1532 Monday through Friday 8 00am 5 00 pm U S A Eastern Standard Time Training Materials Training materials are accessible on our website at TubeClear com Table of Contents Section 1 0 intended Use sec cc cciereseegeuadeed i ie i arenas 1 Section 1 1 Indications for Use 00 0 eee eee 1 Section 1 2 Contraindications 0 0 eee 1 Section 2 0 Cautions scccec e see eei eee esd eee ede eee 2 Section 3 0 Device Description 0 eee cee eee 3 Section 4 0 Set up Instructions 2 0 0 0 000 cece eee 7 Section 5 0 Operating Instructions 00 0 eee eee 11 Section 6 0 Control Box Cleaning Instructions
11. ause this will slow the Wire motion inside the Sheath and decrease efficacy A B TubeClear Operator s Manual 10 5 0 Operating Instructions 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 Read the Operating Instructions and review Flow Diagrams A and B before operating TubeClear TubeClear is to be used while the nasogastric tube is in the Patient Do NOT remove the nasogastric tube to use TubeClear It is recommended that Operators wear eye protection and gloves when operating TubeClear It is recommended that a disposable pad be placed over the Patient s chest and stomach area during use of TubeClear If the Control Box 5 appears to be damaged do NOT use TubeClear If damaged replace the Control Box with a new Control Box See Section 9 0 Return Policy If you do NOT know that the tube is nasogastric distal end resides in the stomach do NOT use TubeClear Verify the length of the Patient s nasogastric tube If you do NOT know the length of the Patient s nasogastric tube do NOT use TubeClear If a TubeClear Clearing Stem model is not available for the size and length of the nasogastric tube to be cleared do NOT use TubeClear Refer to Table 1 for a listing and description of TubeClear models TABLE 1 TubeClear Clearing Stem Models Nasogastric NG Tube Measurements Proper Product Selection Tube Length Tu
12. be Length Feeding Tube 10 14 36 42 91 108 NG 1036 Clear Feeding Tube 10 14 43 50 109 127 AA Sump Tube 10 18 43 50 109 127 AA Levin Tube 10 14 43 50 109 127 GUART ActuatedMedical com Examples f the Patient has a nasogastric tube 10 Fr 36 in 91 cm long select Model Number NG 1036 Clear Color If the Patient has a nasogastric tube 12 Fr 45 in 114 cm long select Model Number NG 1043 Green Color If the Patient has a Sump Tube 18 Fr 48 in 122 cm long select Model Number NG 1043 Green Color 5 11 Verify that the model selected is correct for the Tube Type French Size and Length to be cleared Failure to use the correct Clearing Stem 12 could result in over insertion of the Clearing Stem The label on the Clearing Stem Packaging will identify the Model and indicate the nasogastric tube size s and length s that the Clearing Stem will unclog 5 12 lt Set up TubeClear and attach the Clearing Stem 12 as directed in Section 4 0 Set up Instructions 5 13 Do NOT press down the Start Stop Button 8 until Step 5 17 5 14 Hold the Patient s naso gastric tube in one hand and the Clearing Stem 12 in your other hand illustrated in Figure 8 5 15 Insert the Clearing Stem 12 into the nasogastric tube only a few inches centimeters at this time TubeClear Operator s Manual FIGURE 8 Insertion of the TubeClear Clearing Stem into Nas
13. cement You will be provided with a Return Authorization RA number and return shipping information All returns must be accompanied by a RA number and reason s for return TubeClear Operator s Manual 16 FLOW DIAGRAM PART A Flow Diagram for Operation of TubeClear Nasogastric tube is clogged DO NOT USE TubeClear DO NOT USE TubeClear DO NOT USE TubeClear Have you verified the correct Clearing Stem model was selected Have you verified the size and length of Patient s nasogastric tube Have you verified the Patient s tube is a nasogastric tube YES i Are both a Obtain a new Collar and Clearing Stem that has a Collar and Stem attached YES A The Clearing Stem has a Magnet on the end Connect this end to the gt Set up Control Box immediately TubeClear Read the Set Up Do NOT place the Magnet which is inside the Instructions in the User s Manual Magnet Adapter on or within 6 in 15 cm of pacemakers defibrillators and other electronic devices including but not limited to credit cards video tapes televisions computer monitors and other CRT displays because the magnets may Go To interfere with the operation of those devices Part B 17 ActuatedMedical com FLOW DIAGRAM PART B Flow Diagram for Operation of TubeClear Continued from Part A Yellow Indicator Light Refer to Step 4 9 Adva
14. d of time may depend on the amount of compacted material It movement may be necessary to clear clogged material may also help to move the Clearing Stem backward approximately 4 in 10 cm then forward 4 in 10 cm Repeat the backward and 5 25 With the Control Box 5 ON slowly remove the Clearing Stem forward movement several times IT IS IMPORTANT TO NOTE 12 from the nasogastric tube THAT THE CLEARING STEM NEEDS TO DO THE WORK ANY SIGN OF WIRE KINKING DUE TO OPERATOR FORCE 5 26 Turn off the Control Box 5 by pressing down the Start Stop WILL DECREASE THE CLEARING EFFICACY Button 8 Switching the On Off Power Switch 6 to the OFF position and unplugging the Power Cord 1 will also turn off 5 21 Continue in this manner until the Collar 17 reaches the TubeClear nasogastric tube s external port 20 as illustrated in Figure 9 If this does not occur within five 5 minutes refer to Section 5 27 Do NOT detach the Clearing Stem 12 from the Control 10 Troubleshooting Guide Box 5 until you reach Step 5 32 5 22 NOTE The TubeClear Control Box 5 will automatically turn 5 28 With the Magnet Adapter 14 attached to the Control Box 5 off after operating for ten 10 minutes The Control Box may be loosely coil the Clearing Stem 12 and place it back into the re started by pushing down the Start Stop Button 8 Packaging until Step 5 31 is completed 5 23 After the Collar 17 reaches the nasogastric tube s exte
15. e the Sheath por peses E 1 2 in 0 4 1 1 cm as illustrated in Figure 1 This backward and forward movement of the Wire allows it to break up and clear clogs within nasogastric tubes while the tube remains in the Patient Each Clearing Stem has a Collar permanently attached The Collar limits insertion depth of the Clearing Stem so that the Tip of the Wire does not extend beyond the end of the nasogastric tube s distal ports into the Patient s stomach Because nasogastric tubes come in different sizes and lengths two 2 models of TubeClear Clearing Stems are available The TubeClear Clearing Stem models currently available are listed in Table 1 TABLE 1 TubeClear Clearing Stem Models Nasogastric NG Tube Measurements Proper Product Selection Tube Length Tube Length Feeding Tube 10 14 36 42 91 108 NG 1036 Clear Feeding Tube 10 14 43 50 109 17 O Sump Tube 10 18 43 50 109 127 OE Levin Tube 10 14 43 50 109 127 GUURTHE TubeClear is externally powered A Power Cord and a Power Supply are included with TubeClear The Power Cord plugs into a standard wall outlet 100 240 V 50 60 Hz The Power Supply reduces the voltage to 25 VDC TubeClear components are listed and numbered in Table 2 see page 5 and are shown with corresponding item numbers in Figure 2 see page 6 TubeClear Operator s Manual 4 TABLE 2 TubeClear Component List Item No Name Description
16. fy that both the Collar 17 and the Stem Lock 13 are 4 13 attached as illustrated in Figure 3 If they are not securely attached obtain a new Clearing Stem 12 Do NOT use a Clearing Stem without a Collar because the Collar limits insertion depth lt Pull the Plastic Cap 19 from the Magnet Adapter 14 at the end of the Clearing Stem 12 as illustrated in Figure 4 Place the Plastic Cap inside the Packaging Immediately place the Magnet Adapter of the Clearing Stem to the center of the Diaphragm 11 of the Control Box 5 as shown in Figure 5 see page 9 Do NOT attach the Magnet Adapter to other metal surfaces 4 14 The Magnet Adapter 14 will adhere magnetically to the center of the Diaphragm 11 as shown in Figure 5 Pull gently on the Magnet Adapter to confirm that it is securely attached There TubeClear Operator s Manual FIGURE 4 Removal of the Plastic Cap from the Magnet Adapter 19 PLASTIC CAP will be resistance if the Magnet Adapter is properly attached If the Magnet Adapter is not attached securely reposition the Magnet Adapter onto the Diaphragm center FIGURE 5 Attachment of the Magnet Adapter to the Diaphragm Position the Magnet Adapter in the center of the Diaphragm Pull slightly to confirm the Magnet Adapter is attached securely 11 DIAPHRAGM 14 MAGNET ADAPTER 4 15 4 16 4 17 Firmly place the Stem Lock 13 into the B
17. lear 17 Flow Diagram Part B Diagram for Operation of TubeClear 18 Table 1 TubeClear Clearing Stem Models 0000 cece eens 4 11 Table 2 TubeClear Component List 0000000 cece ee eee 5 Table 3 Guidance amp Manufacturer s Declaration Electromagnetic Emissions 21 Table 4 Guidance amp Manufacturer s Declaration Electromagnetic Immunity 22 Table 5 Guidance and Manufacturer s Declaration Emissions Equipment amp Systems that are NOT Life Supporting 23 Table 6 Recommended Separation Distances for TubeClear Control Box Model 101 s c 5 4 sini biwade aes eeeee au spas 24 TubeClear Operator s Manual 1 0 Intended Use TubeClear is intended to clear occlusions clogs in nasogastric feeding and decompression tubes TubeClear consists of a reusable Control Box Model 101 and single use Clearing Stem Models NG 1036 and NG 1043 1 1 Indications for Use TubeClear is indicated for use only and soley in clearing occlusions clogs in nasogastric NG tubes i e tubes that are placed through the nose and reside in the stomach of adult patients Clearing Stem Model NG 1036 is intended for use in nasogastric tubes that are labeled 10 14 French and have a length of 36 42 in 91 108 cm Clearing Stem Model NG 1043 is intended for use in nasogastric tubes that are labeled 10 18 French and have a length of 43 50 in 109 127 cm
18. nce Does the Clearing Stem advance until the Collar prevents Insert the Turn on Press Clearing Stem the the a few inches Start Stop Clearing centimeters Button Stem further into the i Indicator slowly and movements nasogastric Light gently tube illuminates Move the Remove the Apply slight Clearing Stem Press down Clearing Stem gentle pressure backward and the Start coil loosely to the Clearing forward Stop Button and place into Stem Slight approximately Packaging Do backward 4 in 10 cm NOT disconnect and forward several times the Clearing Stem movements from the Control may be helpful Box at this time If the occlusion Verify that the does not clear i Verify proper after 5 minutes nasogastric tube is placement of the read Section 10 unclogged as per your Troubleshootin Institution s Protocol nasogastric tube Guide Have you Disconnect Dispose of confirmed Turn off the the Clearing Clearing that the Patient s Control Box Stem from the Stem as nasogastric tube Control Box per your is clear Institution s Protocol TubeClear Operator s Manual 18 10 0 Troubleshooting Guide 11 0 Technical Data l 11 1 Environmental Conditions that Affect Use Solution Options Operating conditions From 32 F to 95 F 0 C to 35 C j idi o O If the Wire is not moving The Clearing Stem may be bent or curled near the Control Relati
19. ogastric Tube Hold the Patient s nasogastric tube in one hand and the Clearing Stem in your other hand lt PATIENT S NASOGASTRIC TUBE lt 12 CLEARING 5 16 Switch the On Off Power Switch 6 to the ON position and verify that the Green Indicator Light 7 turns on FIGURE 9 The Collar Limits Insertion of the Clearing Stem The Collar limits further insertion into the nasogastric tube 5 17 Hold both the nasogastric tube and the Clearing Stem 12 with one hand and press down the Start Stop Button 8 with your other hand until Control Box 6 beeps approximately 2 seconds 5 18 Hold the Patient s nasogastric tube in one hand and slowly advance the Clearing Stem 12 with your other hand into the nasogastric tube 5 19 Continue advancing the Clearing Stem 12 until it no longer moves forward 5 20 If the Clearing Stem 12 stops progressing forward before the Collar 17 reaches the nasogastric tube s external port apply 5 24 With the Control Box 5 ON slowly remove the Clearing Stem slight gentle pressure to the Clearing Stem Do NOT force the 12 and repeat Steps 5 15 5 23 at least two 2 times This Clearing Stem The Wire 18 should remain in contact with the will help to clear any material that remains near the stomach clog using gentle pressure for up to five 5 minutes The length end of the nasogastric tube Additional backward and forwar
20. r domestic purposes TubeClear Control Box Model 101 is intended for use in the electromagnetic environment specified above The Operator of TubeClear Control Box Model 101 should assure that it is used in such an environment 21 ActuatedMedical com TABLE 4 Guidance amp Manufacturer s Declaration Electromagnetic Immunity Immunity test IEC 60601 Compliance Electromagnetic Environment test level level Guidance Electrostatic 6KV contact 6kV contact Floors should be wood concrete discharge ESD 8kV air 8KV air or ceramic tile If floors are EN IEC covered with synthetic material 61000 4 2 the relative humidity should be at least 30 Surge 1kV 1kV Mains power quality should be EN IEC differential differential that of a typical commercial or 61000 4 5 2kVcommon 2kV common hospital environment Power frequency 3 A m Power frequency magnetic 50 60 Hz fields should be at levels Magnetic Field characteristic of a typical EN IEC location in a typical commercial 61000 4 8 or hospital environment TubeClear Control Box Model 101 is intended for use in the electromagnetic environment specified above The Operator of TubeClear Control Box Model 101 should assure that it is used in such an environment TubeClear Operator s Manual 22 TABLE 5 Guidance amp Manufacturer s Declaration Emissions Equipment and Systems that are NOT Life Supporting Immunity test IEC 6060
21. racket Adapter 15 and verify the connection is secure Figure 6A shows the correct Stem Lock placement Proper placement of the Stem Lock is necessary for effective operation Do NOT operate TubeClear if Stem Lock 13 is not securely placed in Bracket Adapter 15 Incorrect placement of Stem Lock as shown in Figure 6B will cause TubeClear to operate inefficiently You may loosely coil the Clearing Stem 12 around your hand to help control the Clearing Stem length while inserting it into the nasogastric tube See Figure 7A ActuatedMedical com FIGURE 6 A Correct Placement of the Stem Lock in the Bracket Adapter Place the Stem Lock securely in the Bracket Adapter for optimum performance B Incorrect Placement of the Stem Lock in the Bracket Adapter Do NOT operate the Control Box if the Stem Lock is not seated correctly on the Bracket Adapter 4 18 Do NOT tightly coil the Clearing Stem 12 around your hand as shown in Figure 7B before or during use because this will slow the Wire 18 motion inside the Sheath 16 and decrease efficacy Refer to Figure 7 for guidance on how to hold the Clearing Stem FIGURE 7 A Correct Handling of the Clearing Stem Loosely wrap the Clearing Stem around your hand as the Clearing Stem is inserted into the nasogastric tube B Incorrect Handling of the Clearing Stem Do NOT tightly coil the Clearing Stem around your hand before or during use bec
22. rnal 5 29 Verify that the nasogastric tube is properly placed in the port 20 as illustrated in Figure 9 see page 14 move the stomach using your Institution s protocol Clearing Stem 12 backward approximately 4 in 10 cm then forward until the Collar reaches the nasogastric tube s external 5 30 Verify that the Patient s nasogastric tube is clear using your port again Institution s Protocol 13 ActuatedMedical com TubeClear Operator s Manual 14 5 31 If the nasogastric tube is still clogged repeat Steps 5 13 5 30 with TubeClear 5 32 After verifying the nasogastric tube is clear disconnect the Clearing Stem 12 from the Control Box 5 by gently lifting the Stem Lock 13 out of the Bracket Adapter 15 and then gently pulling upward on the Magnet Adapter 14 to separate it from the Diaphragm 11 5 33 Replace the Plastic Cap 19 on the Magnet Adapter 14 of the Clearing Stem 12 prior to disposal 5 34 Do NOT dispose of the Clearing Stem 12 with ordinary waste Dispose of the Clearing Stem as regulated medical waste in accordance with applicable government regulations and your Institution s Protocol 5 35 If any of the de clogged contents from the nasogastric tube come into contact with the Patient or any surfaces consider the de clogged contents to be similar to vomitus Clean the Patient and surfaces in accordance with your Institution s Protocol 6 0 Control Box Cleaning Instructions
23. ve humidity from 30 to 75 or is moving slowly Box Bracket Adapter If so straighten the Clearing Stem X Transport and storage conditions From 4 F to 140 F The Magnet Adapter may not be well attached to the 20 C to 60 C Relative humidity from 10 to 90 Control Box Diaphragm see Figure 5 The Stem Lock may not be firmly secured in the Control 11 2 Classification TubeClear is Box Bracket Adapter see Figure 6 classified as IEC Class II Equipment classified as Type B applied part an externally powered device type IPX4 non sterile NOT suitable for use in the presence of flammable anesthetics suitable for continuous operation The Clearing Stem may be too tightly wrapped around your hand see Figure 7 t eeet 11 3 Accessories Power Cord Hospital Grade Unshielded IEC320 Connector ROHS Compliant Power Supply Transformer Input 100 240 V 50 60 Hz Output 24VDC up to 2 71A 3 pin IEC 320 Inlet ROHS Compliant If the clog has not been Remove the Clearing Stem from the nasogastric tube and Cleared after 10 minutes verify the Wire is moving backward and forward If the Wire Use of Power Supplies and Power Cords other than of operation _ moves freely while the Clearing Stem is outside of the those specified in Section 3 0 may result in improper nasogastric tube repeat the procedure from Section 5 0 Steps P y P OR aa sy a
24. w your Institution s Protocol for insertion of a new nasogastric tube TubeClear may cause some discomfort to the nasal passage during use TubeClear contains magnets Magnets are inside the Control Box and at the end of the Clearing Stem that attaches to the Control Box Do NOT place the Control Box and the Magnet at the end of the Clearing Stem within 6 in 15 cm of pacemakers defibrillators and other electronic devices including but not limited to credit cards video tapes televisions computer monitors and other CRT displays because the magnets may interfere with the operation of those devices Pop Ensure that the Control Box is securely mounted to an IV pole or level table to reduce the risk of the Control Box falling TubeClear is non sterile It is intended for use with nasogastric NG tubes and does NOT require sterile conditions for its intended purpose Do NOT use TubeClear in any manner that would require sterile conditions TubeClear Operator s Manual 2 Federal law U S restricts TubeClear to sale by or on the order of a physician AN Attention read instructions before use Do NOT operate in the presence of flammable anesthetics Flammable anesthetics are gases or vapors including but not limited to fluroxene ethyl chloride ethyl ether and ethylene which may form flammable or explosive mixtures with air oxygen or reducing gases such as nitrous oxide K Do NOT dispose
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