CellAegis autoRIC User Manual

Remote ischemic conditioning device

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Summary of Contents for CellAegis autoRIC

Page 3 CellAegis Devices Inc. The information contained herein is subject to change without notice.
Page 4: Table Of Contents
The autoRIC Device User’s Manual Table of Contents Intentions and Introduction .................1 Intent of Manual ....................1 Introduction .....................1 Intended Use of the autoRIC Device ............1 Contraindications ....................1 Target Population ....................2 Operating Principle / Theory of Operation ............2 Symbols and Messages ..................3 Advice, Cautions and Warnings ..............3...
Page 5 CellAegis Devices Inc. The autoRIC Device User’s Manual Error Displays and Troubleshooting ..............28 Battery and Error Indicators ................28 Applicator Cuff Problems ................30 Charging Problems ..................30 General Instructions for Safety ..............31 Care, Maintenance and Disposal ..............32 Cleaning the Control Unit ................32 System and Accessories Maintenance ............32...
Page 6 Wall-Mount Attachment for Charging Cradle ........12 Figure 10: Applicator Components ..............12 Figure 11: Applicator Showing Red Size Indicator Marks ......13 Figure 12: The autoRIC Package Components ..........18 Figure 13: Select Appropriate Adaptor ............20 Figure 14: Protective Cover Removed ............20 Figure 15: North American Adaptor Selected..........21 Figure 16: Snapping Adaptor into Place ............21...
Page 7 CellAegis Devices Inc. The autoRIC Device User’s Manual List of Tables Table 1: Cuff Size Selection ................23 Table 2: Battery 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...
Page 9: Intentions And Introduction
Introduction CellAegis Devices Inc (CDI) is a Toronto-based designer and manufacturer of safe, non-invasive and cost effective medical devices. CellAegis plans to build on market acceptance of remote ischemic conditioning through continued support of clinical research projects and development of the market world- wide.
Page 10: Target Population
The autoRIC is a new, portable, automated conditioning device (autoRIC CellAegis Devices, Canada) that consists of a cuff into which a ‘one button’ battery-driven actuator system inserts. This provides for a mobile ‘point-of-care’ delivery of RIC that will not impose on other care delivery, and requires no special expertise for its use.
Page 11: Symbols And Messages
WARNING Device and Label Symbols The following table lists the symbols used on the autoRIC device and labels and explains their meaning and / or significance. Symbol Meaning / Significance Manufacturer’s Address...
Page 12 CellAegis Devices Inc. The autoRIC Device User’s Manual Symbol Meaning / Significance Temperature 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 regarding allowable leakage currents and reliability of the protective earth connection.
Page 13: Warnings And Cautions
CellAegis Devices Inc. The autoRIC Device User’s Manual Warnings and Cautions Risks WARNING! USE OF THE DEVICE UNDER NORMAL OPERATING CONDITIONS MAY RESULT IN DAMAGE TO THE LIMB IF NOT USED ACCORDING TO INSTRUCTIONS. IT IS CRITICAL THAT THIS MANUAL BE READ AND UNDERSTOOD PRIOR TO USE BY A HEALTHCARE PROFESSIONAL OR TRAINED OPERATOR.
Page 14: Electrical Safety Warnings
AUTHORIZED SERVICE PERSONNEL. CAUTION! THE USE OF ACCESSORIES AND CABLES OTHER THAN THOSE SPECIFIED, 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 INC. CHARGING CRADLE (REF: CRG-0001) CONTAINING GLOBTEK INC.
Page 15: Product Features
The Control Unit is a stand-alone reusable controller that clicks into the disposable applicator cuff when it is ready for use. Figure 1: autoRIC Controller CAUTION! USE ONLY CELLAEGIS DEVICES INC. CHARGING CRADLE (REF: CRG-0001) TO CHARGE THE CONTROL UNIT. www.cellaegisdevices.com |...
Page 16: Applicator Cuff
CellAegis Devices Inc. The autoRIC Device User’s Manual Applicator Cuff The Applicator Cuff is a single- use, disposable cuff made of a comfortable polyester material. It is fastened using Velcro. There is an integral plastic holder where the control unit is attached.
Page 17: Charging Cradle
Control Unit inserted into the Charging Cradle – at right.) Figure 4: Charging Cradle Figure 5: Control Unit in Charging Cradle CAUTION! DO NOT PLUG ANY DEVICES OTHER THAN THE CELLAEGIS autoRIC CONTROL UNIT INTO THE CHARGING CRADLE. www.cellaegisdevices.com |...
Page 18: Device Parts
CellAegis Devices Inc. The autoRIC Device User’s Manual Device Parts Control Unit Figure 6: Control Unit Components | www.cellaegisdevices.com...
Page 19: Charging Cradle Components
CellAegis Devices Inc. The autoRIC Device User’s Manual Charging Cradle Components Figure 7: Charging Cradle Components Figure 8: International Power Adaptors www.cellaegisdevices.com |...
Page 20: Applicator Cuff Components
CellAegis Devices Inc. The autoRIC Device User’s Manual Figure 9: Wall-Mount Attachment for Charging Cradle Applicator Cuff Components Figure 10: Applicator Components | www.cellaegisdevices.com...
Page 21: Figure 11: Applicator Showing Red Size Indicator Marks
CellAegis Devices Inc. The autoRIC Device User’s Manual 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). Figure 11: Applicator Showing Red Size Indicator Marks...
Page 22: Product Labeling
The autoRIC Device User’s Manual Product Labeling The following tables illustrate the labels that are present on the autoRIC 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 Cuff size.
Page 23 CellAegis Devices Inc. The autoRIC Device User’s Manual Name / Description Label Image Medium - Applicator Cuff APM-001 packaging label STERILE 0473 139 Mulock Ave. Toronto, ON, Canada M6N 1G9 www.cellaegisdevices.com Large - Applicator Cuff APL-001 packaging label STERILE 0473 139 Mulock Ave.
Page 24: Device Labels
CellAegis Devices Inc. The autoRIC Device User’s Manual Device Labels The following labels are or may be (depending on global location) mounted on the autoRIC Control Device or its auxiliary components (i.e., charging cradle and wall mount). Name / Description...
Page 25 CellAegis Devices Inc. The autoRIC Device User’s Manual Name / Description Label Image Charging Cradle back label 0473 Connect to GLOBTEK INC. 139 Mulock Ave. Model: GTM41060-1809 PSU only Toronto, ON, Canada M6N 1G9 IPC-039-RevB www.cellaegisdevices.com Control Unit investigational device label...
Page 27: Instructions
Wall Mount for Charging Cradle (with wall plugs and screws) Power Adaptor for Charging Cradle Figure 12: autoRIC Package Components 2. Decide whether you want to use the autoRIC in the Table Top or the Wall Mount configuration. www.cellaegisdevices.com |...
Page 28: Charging Cradle Wall Mounting Instructions
CellAegis Devices Inc. The autoRIC Device User’s Manual Charging Cradle Wall Mounting Instructions ADVICE: If you decide to wall mount the Charging Cradle, securely attach the Charging Cradle to a flat surface using the wall plugs and screws provided. Be sure to use a level to ensure proper mounting.
Page 29: Selecting The Correct International Power Adaptor
CellAegis Devices Inc. The autoRIC Device User’s Manual Selecting the Correct International Power Adaptor The autoRIC system is shipped with three (3) international adaptors. 1. Decide on the correct international adaptor for your location (see Figure below). Figure 13: Select Appropriate Adaptor 2.
Page 30: Figure 15: North American Adaptor Selected
CellAegis Devices Inc. The autoRIC Device User’s Manual 3. Select the appropriate adaptor. Figure 15: North American Adaptor Selected 4. Snap the adaptor into place. Figure 16: Snapping Adaptor into Place | www.cellaegisdevices.com...
Page 31: Once The Unit Is Set Up
CellAegis Devices Inc. The autoRIC Device User’s Manual Figure 17: Adaptor in Place Once the Unit Is Set Up 5. Once the Charging Cradle is set up, plug into a convenient wall outlet. Avoid positioning the charging cradle, so that access to the wall outlet and plug is blocked or limited.
Page 33: Use Instructions
CellAegis Devices Inc. The autoRIC Device User’s Manual Use Instructions WARNING! BEFORE ATTEMPTING TO OPERATE THE autoRIC DEVICE, READ ALL CONTRAINDICATIONS LISTED ON PAGE 1. USING THE autoRIC DEVICE ON CONTRAINDICATED 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.
Page 34: Figure 20: Start Button On Control Unit
CellAegis Devices Inc. The autoRIC Device User’s Manual 3. Affix Applicator Cuff to patient arm. ADVICE: • The patient should be supine, sitting or reclining with arms extended by their side. • The Applicator Cuff must be placed on the upper arm above the elbow.
Page 35: Patient Instructions
CellAegis Devices Inc. The autoRIC Device User’s Manual Patient Instructions • Device is not to be applied over clothing. • Patient is to be relaxed and sitting or lying down. They should refrain from moving during the procedure – especially during the deflation cycle –...
Page 36: Procedure Complete
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 autoRIC device be returned to the Charging Cradle. • If required, the autoRIC device will run up to five(5) complete cycles without requiring charging.
Page 37: Errors
An error has occurred when the indicator (shown in Figure 21: below) is lit. Figure 21: Error Indicator To reset after correcting an error, press the Stop/Reset button (shown lit at top right in Figure 21.) Turning Off the autoRIC Device The autoRIC device will automatically enter “Sleep” mode (which saves energy) after approximately three (3) minutes of inactivity.
Page 39: Error Displays And Troubleshooting
CellAegis Devices Inc. The autoRIC Device User’s Manual Error Displays and Troubleshooting Battery and Error Indicators The following table details battery and error indicators and provides troubleshooting steps to correct them. Troubleshooting Warning/Error Indications Possible Cause Steps Battery Light Visual Indicates that •...
Page 40 Clear Error. 6. Press Start button to initiate a new procedure. NOTE: If the problem persists after replacing applicator, and following the above steps, contact CellAegis Servicing or your local distributor. Table 2: Battery and Error Indicators | www.cellaegisdevices.com...
Page 41: Applicator Cuff Problems
3. If the blue light continues to flash after more than three (3) hours, return the device to CellAegis Devices Inc. for servicing. Control unit will not engage in Confirm there is no debris in the charging cradle.
Page 42: General Instructions For Safety
CellAegis Devices Inc. The autoRIC Device User’s Manual General Instructions for Safety 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 manufacturer. If the device malfunctions, return to the dealer or manufacturer for servicing according to the warranty.
Page 43: Care, Maintenance And Disposal
Cleaning the Control Unit The exterior surfaces of the autoRIC can be cleaned with a isopropyl alcohol. DO NOT use cleaning agents that contain abrasives. The autoRIC is splash resistant, so spraying with cleaning solution should not affect performance. ADVICE: Refer to cleaning agents manufacturer’s instructions for use procedures.
Page 44: Disposal Instructions For Device And Applicator Cuff
Batteries are only to be disposed of and replaced by qualified service personnel. Batteries are not suitable for regular trash disposal and will be recycled by CellAegis Devices Inc., or the local distributor as per local municipal regulations. | www.cellaegisdevices.com...
Page 45: Replacement Parts
CellAegis Devices Inc. The autoRIC Device User’s Manual 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 Adaptor Kit ADP–0001 Wall Mount MNT–0001 Table 5: Replacement Parts...
Page 46: Specifications
CellAegis Devices Inc. The autoRIC Device User’s Manual Specifications Specification Parameters Theory of Operation Automates the process of protecting patients against ischemia-reperfusion injury by automating 4 cycles of ischemia and reperfusion stimulus. Each cycle consists of a 5-minute inflation period at 200 mmHg (ischemia) and a 5-minute deflation period (reperfusion).
Page 47 CellAegis Devices Inc. The autoRIC Device User’s Manual Specification Parameters Weight and Size of Control Unit • Weight: 10 oz (286 g) • Width: 3.4 in (87 mm) • Height: 5 in (127 mm) • Depth: 1.4 in (35 mm)
Page 48: Electrical Safety And Emc Declarations
Electrical Safety and EMC Declarations Manufacturer’s Declaration The autoRIC device is intended for use in the electromagnetic environment specified below. The customer or the user of the autoRIC device should assure that it is used in such an environment. Emissions Compliance Electromagnetic environment –...
Page 49: Table 8: Manufacturer's Immunity Declaration
The autoRIC Device User’s Manual The autoRIC device is intended for use in the electromagnetic environment specified below. The customer or the user of the autoRIC device should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment –...
Page 50: Table 9: Manufacturer's Immunity Test Declaration
The autoRIC Device User’s Manual The autoRIC device is intended for use in the electromagnetic environment specified below. The customer or the user of the autoRIC device should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment –...
Page 51: Table 10: Manufacturer's Seperation Distances Declaration
The autoRIC device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the autoRIC device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the autoRIC...
Page 52: Warranty And Service
CellAegis Devices Inc. The autoRIC Device User’s Manual Warranty and Service For the Control Unit Warranty includes 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.
Page 53: Index
Charging Cradle Specifications about, 9 of autoRIC device, 35 components, 11 Symbols wall mounting, 19 on device & labels, 3 Charging of autoRIC Warnings troubleshooting problems, 30 about, 5 Cleaning Warranty Control Unit, 32 description of, 41 Contraindications, 1 Control Unit...
Page 56 CellAegis Devices Inc. is certified to ISO 13485:2003, CMDCAS CellAegis Devices Inc. 139 Mulock Avenue Toronto, Ontario M6N 1G9 Canada www.cellaegisdevices.com info@cellaegisdevices.com Phone: 1-647-722-9601 Fax: 1-647-722-9553 IPC-101 Rev. B January 2013...