CellAegis autoRIC User Manual Download Page 1

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Summary of Contents for autoRIC

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Page 3: ...contained herein is subject to change without notice All brand and product names mentioned herein are used for identification purposes only and are trademarks or registered trademarks of their respec...

Page 4: ...Electrical Safety Warnings 6 Product Features 7 Control Unit 7 Applicator Cuff 8 Charging Cradle 9 Device Parts 10 Control Unit 10 Charging Cradle Components 11 Applicator Cuff Components 12 Product...

Page 5: ...ing Problems 30 General Instructions for Safety 31 Care Maintenance and Disposal 32 Cleaning the Control Unit 32 System and Accessories Maintenance 32 Disposal Instructions for Device and Applicator C...

Page 6: ...e 8 International Power Adaptors 11 Figure 9 Wall Mount Attachment for Charging Cradle 12 Figure 10 Applicator Components 12 Figure 11 Applicator Showing Red Size Indicator Marks 13 Figure 12 The auto...

Page 7: ...and Error Indicators 28 Table 3 Applicator Problems 30 Table 4 Charging Problems 30 Table 5 Replacement Parts 34 Table 6 Specifications 35 Table 7 Manufacturer s Emissions Declaration 37 Table 8 Manuf...

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Page 9: ...edure Intended Use of the autoRICTM Device The autoRICTM device is intended to provide remote ischemic conditioning to adult patients over 18 years of age undergoing cardiothoracic surgery or interven...

Page 10: ...is a new portable automated conditioning device autoRICTM CellAegis Devices Canada that consists of a cuff into which a one button battery driven actuator system inserts This provides for a mobile poi...

Page 11: ...are not followed can cause fatal or serious injuries to a user engineer patient or any other person or can lead to a mistreatment Device and Label Symbols The following table lists the symbols used o...

Page 12: ...Limitation Humidity Limitation Single Use Only Not Suitable for Regular Trash Disposal Type BF Device Equipment providing a particular degree of protection against electric shock particularly regardi...

Page 13: ...SINGLE USE DISPOSABLE ACCESSORY AND MUST BE DISCARDED AFTER USE ON AN INDIVIDUAL PATIENT CAUTION PERFORMANCE MAY BE AFFECTED IF DEVICE IS USED OR STORED OUTSIDE OF THE TEMPERATURE AND HUMIDITY RANGES...

Page 14: ...FIED WITH THE EXCEPTION OF ACCESSORIES AND CABLES QUALIFIED AND SOLD BY CELLAEGIS DEVICES INC MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE PRODUCT CAUTION USE ONLY CELLAEGIS DEVICES...

Page 15: ...ree 3 components which are detailed and shown in the following sections Control Unit The Control Unit is a stand alone reusable controller that clicks into the disposable applicator cuff when it is re...

Page 16: ...terial It is fastened using Velcro There is an integral plastic holder where the control unit is attached The Applicator cuffs are available in three 3 adult sizes and will accommodate the following a...

Page 17: ...r Supply Model GTM41060 1809 and consists of a simple release button to release the control unit when ready for use Note the position of the blue release button in the two photos without and with the...

Page 18: ...CellAegis Devices Inc The autoRICTM Device User s Manual 10 www cellaegisdevices com Device Parts Control Unit Figure 6 Control Unit Components...

Page 19: ...CellAegis Devices Inc The autoRICTM Device User s Manual www cellaegisdevices com 11 Charging Cradle Components Figure 7 Charging Cradle Components Figure 8 International Power Adaptors...

Page 20: ...CellAegis Devices Inc The autoRICTM Device User s Manual 12 www cellaegisdevices com Applicator Cuff Components Figure 9 Wall Mount Attachment for Charging Cradle Figure 10 Applicator Components...

Page 21: ...nual www cellaegisdevices com 13 ADVICE When the Applicator Cuff is positioned on the arm the Vertical red line MUST be within the area defined by the Horizontal red line as shown in the photo below F...

Page 22: ...M device and packaging The majority of the labels are not shown in actual size Packaging Labels Note that the figure shown in solid view as opposed to outline on the label indicates the Applicator Cuf...

Page 23: ...on Label Image Medium Applicator Cuff packaging label Large Applicator Cuff packaging label APM 001 IPC 098 RevB 139 Mulock Ave Toronto ON Canada M6N 1G9 www cellaegisdevices com NON STERILE 0473 APL...

Page 24: ...om Device Labels The following labels are or may be depending on global location mounted on the autoRICTM Control Device or its auxiliary components i e charging cradle and wall mount Name Description...

Page 25: ...back label Control Unit investigational device label Control Unit investigational device label USA Control Unit investigational device label Europe Control Unit commercial device label Europe Connect...

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Page 27: ...fter unpacking ensure that you have the following components o Control Unit o Charging Cradle o Wall Mount for Charging Cradle with wall plugs and screws o Power Adaptor for Charging Cradle 2 Decide w...

Page 28: ...the wall through the three 3 mounting holes 4 Drill three 3 6 35 mm holes 5 Insert the wall plugs into the drilled holes 6 Position the Wall Mount plastic attachment over the holes 7 Screw the three...

Page 29: ...Adaptor The autoRICTM system is shipped with three 3 international adaptors 1 Decide on the correct international adaptor for your location see Figure below 2 Remove the protective cover from the powe...

Page 30: ...ces Inc The autoRICTM Device User s Manual 21 www cellaegisdevices com 3 Select the appropriate adaptor 4 Snap the adaptor into place Figure 15 North American Adaptor Selected Figure 16 Snapping Adapt...

Page 31: ...venient wall outlet Avoid positioning the charging cradle so that access to the wall outlet and plug is blocked or limited 6 Insert the Control Unit into the Charging Cradle and leave it until the Bat...

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Page 33: ...TED PATIENTS MAY CAUSE NERVE AND BONE DAMAGE 1 Determine if patient meets the criteria for RIC treatment by measuring the patient s upper arm for appropriate size 2 Select the appropriate cuff size by...

Page 34: ...rks see Figure 18 on the previous page should be over the inner part of the arm The Applicator Cuff should be placed so that the Control Unit is on the outside of the patient s arm and facing away fro...

Page 35: ...lease allow adequate time for entire procedure The autoRICTM device delivers four 4 RIC cycles of five 5 minutes of pressure at approximately 200 mm Hg followed by five 5 minutes of no pressure The Ap...

Page 36: ...o your institution s medical waste policy 3 Clean the Control Unit with isopropyl alcohol and place it back into the charging cradle Charging After Use It is recommended that after each use the autoRI...

Page 37: ...ndicator shown in Figure 21 below is lit To reset after correcting an error press the Stop Reset button shown lit at top right in Figure 21 Turning Off the autoRICTM Device The autoRICTM device will a...

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Page 39: ...Visual indicator blinks blue Indicates that battery is low but can still perform at least one complete procedure Can still perform at least one complete RIC procedure Complete procedure and return con...

Page 40: ...ove control unit from applicator and make sure control unit applicator connection is free from debris 4 Replace applicator by obtaining a new unused applicator Remove packaging and insert control unit...

Page 41: ...rovides steps to correct them Problem Correction Charging indicator light does not appear 1 Confirm that the unit is fully engaged in the charging cradle and that the applicator eject lever is in the...

Page 42: ...afety If device does not operate as intended after making any of the corrections detailed above DO NOT TAMPER WITH THE INTERNAL MECHANISMS OR REPLACE THE BATTERY Contact your distributor or the manufa...

Page 43: ...rviceable components inside the autoRICTM Control Unit or Charging Cradle CAUTION DO NOT DROP THE autoRICTM DEVICE OR EXPOSE TO HIGH TEMPERATURES HUMIDITY SHOCK DUST OR DIRECT SUNLIGHT If the autoRICT...

Page 44: ...ispose of disposable applicator cuff as per your institution s biomedical waste disposal policies DO NOT return used applicators to manufacturer or distributor If assistance is desired in the proper d...

Page 45: ...laegisdevices com 34 Replacement Parts Part Name Part Number Control Unit RIC 0001 Small Applicator APS 001 Medium Applicator APM 001 Large Applicator APL 001 Charging Cradle CRG 0001 Power Supply Ada...

Page 46: ...sion Pressure Range 200 mmHg for 5 minutes Inflation 5 minutes Deflation 5 minutes Power Supply Control Unit 9V DC Charging Cradle AC 9V DC Power Consumption 100 240 VAC 50 60 Hz 0 6A Operating Enviro...

Page 47: ...g Width 3 4 in 87 mm Height 5 in 127 mm Depth 1 4 in 35 mm IP Rating IPX4 Electrical Safety Rating This device complies with the electrical safety and EMC standards of IEC 60601 Type of Protection Cl...

Page 48: ...lectronic equipment RF emissions CISPR 11 Class A The equipment is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to...

Page 49: ...line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage v...

Page 50: ...veya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of known RF transmitting devices and equipment marked with the following symbol NOTE 1 At...

Page 51: ...M device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the autoRICTM device as recommended be...

Page 52: ...udes parts and labour costs for one 1 year from date of manufacture For the Applicators Replacement of applicator cuffs for up to six 6 months from date of manufacture Servicing Address Products requi...

Page 53: ...ons 1 Control Unit about 7 components 10 Copyright statement of i Disposal instructions for 33 Electrical Safety Warnings list of 6 Errors indication of correcting 27 Indicators of battery and error 2...

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Page 56: ...ISO 13485 2003 CMDCAS www cellaegisdevices com IPC 101 Rev B January 2013 CellAegis Devices Inc 139 Mulock Avenue Toronto Ontario M6N 1G9 Canada www cellaegisdevices com info cellaegisdevices com Pho...

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