CellAegis autoRIC User manual

CellAegis Devices Inc. The autoRICTM Device User’s Manual
www.cellaegisdevices.com | i
Notices
Copyright Statement
No part of this publication may be reproduced, translated into another
language, stored in a retrieval system or transmitted, in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise without
the prior written consent of CellAegis Devices Inc. The information contained
herein is subject to change without notice.
All brand and product names mentioned herein are used for identication
purposes only and are trademarks or registered trademarks of their respective
holders. CellAegis™ and autoRIC™ are trademarks of CellAegis Devices Inc.
Patent Information
Protected by US Patent # US 7,717,855 B2. Additional patents pending.
See www.cellaegisdevices.com/contact.html for current patent information.
CellAegis Devices Inc.
139 Mulock Avenue
Toronto, Ontario
M6N 1G9 Canada
www.cellaegisdevices.com
[email protected]
Phone: [phone]
Fax: [phone]

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Table of Contents
Intentions and Introduction .................................................................................1
Intent of Manual ..............................................................................................1
Introduction .....................................................................................................1
Intended Use of the autoRICTM Device ...........................................................1
Contraindications ............................................................................................1
Target Population............................................................................................2
Operating Principle / Theory of Operation ......................................................2
Symbols and Messages .....................................................................................3
Advice, Cautions and Warnings......................................................................3
Device and Label Symbols .............................................................................3
Warnings and Cautions ......................................................................................5
Risks ...............................................................................................................5
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 Labeling...............................................................................................14
Packaging Labels..........................................................................................14
Device Labels ...............................................................................................16
Instructions .......................................................................................................18
Prior to Use...................................................................................................18
Unpacking .................................................................................................18
Charging Cradle Wall Mounting Instructions .............................................19
Selecting the Correct International Power Adaptor ...................................20
Once the Unit Is Set Up.............................................................................22
Use Instructions ............................................................................................23
Patient Instructions .......................................................................................25
Device Operation and Duration of Procedure...............................................25
Procedure Complete.....................................................................................26
Charging After Use........................................................................................26
Errors ............................................................................................................27
Turning Off the autoRICTM Device.................................................................27

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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
Disposal Instructions for Device and Applicator Cuff ....................................33
Replacement Parts...........................................................................................34
Specifications ...................................................................................................35
Electrical Safety and EMC Declarations...........................................................37
Warranty and Service.......................................................................................41
For the Control Unit.......................................................................................41
For the Applicators........................................................................................41
Servicing Address .........................................................................................41
Index.................................................................................................................42

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Table of Figures
Figure 1: The autoRICTM Controller................................................................7
Figure 2: Applicator Cuff Unfolded.................................................................8
Figure 3: Applicator Cuff Folded ....................................................................8
Figure 4: Charging Cradle..............................................................................9
Figure 5: Control Unit in Charging Cradle.....................................................9
Figure 6: Control Unit Components .............................................................10
Figure 7: Charging Cradle Components ..................................................... 11
Figure 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 autoRICTM 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
Figure 17: Adapter in Place ...........................................................................22
Figure 18: Applicator Cuff ..............................................................................23
Figure 19: Device on Patient’s Arm................................................................23
Figure 20: Start Button on Control Unit..........................................................24
Figure 21: Error Indicator...............................................................................27

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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: Specications......................................................................................35
Table 7: Manufacturer’s Emissions Declaration ...............................................37
Table 8: Manufacturer’s Immunity Declaration .................................................38
Table 9: Manufacturer’s Immunity Test Declaration..........................................39
Table 10: Manufacturer’s Seperation Distances Declaration............................40

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Intentions and Introduction
Intent of Manual
This manual is intended to assist the user in the safe and effective operation of
the Automated Remote Ischemic Conditioner (autoRICTM). The product must be
used in accordance with the procedures contained in this manual and must not
be used for purposes other than those described herein. It is essential to read
and understand the entire manual.
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. CellAegis has developed the world’s only patented automated ischemic
conditioning device, which prepares the heart to better cope with an acute
cardiac event or a planned interventional cardiac procedure.
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 interventional cardiothoracic procedures or patients with evolving
myocardial infarction. The autoRICTM device is intended for use in the hospital
setting, ambulance setting or in a home setting as directed by a healthcare
professional.
Contraindications
The autoRICTM device is contraindicated for patients with a systolic blood
pressure above 200 mmHg, patients treated with hemodialysis, or patients
treated with anticoagulants, antiplatelet therapy, steroids, or with a known
bleeding disorder or known abnormality of blood ow to the limb. It is also
contraindicated for patients with osteoporosis or other bone disorders,
peripheral nerve injury, abnormal nerve supply, peripheral neuropathy, or pre-
existing traumatic injury to the limb.
Using the autoRICTM device on patients with the listed contraindications may
cause nerve and bone damage. Using the autoRICTM device on hypertensive
patients with a systolic pressure of over 180 mmHg may result in reduced
effectiveness of ischemic conditioning.

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Target Population
The target population is adult patients over 18 years of age undergoing,
cardiovascular surgical or interventional cardiologic procedures and patients
with evolving myocardial infarction.
Operating Principle / Theory of Operation
Remote Ischemic Conditioning (RIC) is a powerful, innate, mechanism of
protection against ischemia-reperfusion injury1. This simple, non-invasive
stimulus is induced in patients by four (4) cycles of ination (ischemia) and
deation (reperfusion) administered by the autoRICTM device when placed on
the upper arm.
The autoRICTM 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 ‘point-of-care’
delivery of RIC that will not impose on other care delivery, and requires no
special expertise for its use.
The active device is programmed to inate the cuff to a pressure of 200
mmHg for ve (5) minutes (ischemia). The cuff will then be deated for ve (5)
minutes (reperfusion) completing one cycle of ischemia-reperfusion. A total of
four (4) ination and deation cycles is applied. At the end of this automated
process, the Procedure Complete indicator is illuminated and an audible tone is
heard/sounded.
1. Kharbanda RK, Nielsen TT, Redington AN. Translation of remote ischemic
preconditioning into clinical practice. Lancet 2009; 374: 1557–65

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Symbols and Messages
Advice, Cautions and Warnings
ADVICE Refer to instruction manual/ booklet.
CAUTION
Cautions are directions which, if they are not followed, can
cause damage to the system described in this manual.
WARNING
Warnings are directions which, if they 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 on the autoRICTM device and labels
and explains their meaning and / or signicance.
Symbol Meaning / Signicance
Manufacturer’s Address
Device Restricted to Sale by or on the Order of a
Licensed Medical Practitioner
Product Reference Number
Product Serial Number
Consult Accompanying Documents
DC Power
AC Power
Double Insulation
Expiration Date

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Symbol Meaning / Signicance
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. Isolated or oating applied part or parts.

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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.
WARNING! MINOR DISCOMFORT DURING THE PROCEDURE IS
EXPECTED.
WARNING! TEMPORARY DISCOLORATION OF THE LIMB WILL OCCUR
DURING BOTH THE INFLATE AND DEFLATE CYCLES.
WARNING! MINOR BRUISING AND ABRASIONS MAY BE EXPERIENCED
ON THE UPPER ARM FOLLOWING THE PROCEDURE. THESE ARE
EXPECTED TO RESOLVE WITHOUT MEDICAL INTERVENTION.
CAUTION! THE APPLICATOR CUFF IS A 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
LISTED IN THE SPECIFICATIONS SECTION OF THIS MANUAL.
WARNING! THIS DEVICE IS INTENDED FOR ADULTS AND IS NOT
INTENDED FOR USE ON CHILDREN.
CAUTION! DO NOT USE APPLICATOR CUFF, AC ADAPTORS OR
BATTERIES OTHER THAN THOSE INCLUDED WITH THE PRODUCT
OR REPLACEMENT PARTS SUPPLIED BY THE MANUFACTURER.
SUBSTITUTION OF A COMPONENT DIFFERENT FROM THAT SUPPLIED
MAY RESULT IN PERFORMANCE ERROR
CAUTION! APPLICATOR CUFF MUST BE PLACED DIRECTLY ON THE
PATIENT WITHOUT ANY ANY TUBING OR OTHER FOREIGN OBJECTS
BETWEEN THE APPLICATOR CUFF AND THE PATIENT.
CAUTION! APPLICATOR CUFF SHOULD NOT BE PLACED OVER THE
ELBOW JOINT.
WARNING! IF THE STOP BUTTON DOES NOT FUNCTION AS
DESCRIBED, REMOVE THE APPLICATOR CUFF FROM THE
PATIENT’S ARM.

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Electrical Safety Warnings
WARNING! DO NOT USE IN AN EXPLOSIVE ENVIRONMENT SUCH AS
ONE WHERE FLAMMABLE ANESTHETICS EXIST, OR INSIDE AN OXYGEN
CHAMBER WITH STRONG ELECTROSTATIC AND ELECTROMAGNETIC
FIELDS.
WARNING: NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.
CAUTION! CONTROL UNIT IS NOT TO BE OPENED EXCEPT BY
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. POWER SUPPLY MODEL:
GTM41060-1809 ONLY.
CAUTION! DO NOT PLUG ANY DEVICES OTHER THAN CELLAEGIS
autoRICTM CONTROL UNIT INTO THE CHARGING CRADLE.
CAUTION! INTERFERENCE MAY OCCUR IN THE VICINITY OF KNOWN
RADIO FREQUENCY (RF) TRANSMITTING DEVICES AND EQUIPMENT
MARKED WITH THE FOLLOWING SYMBOL:
CAUTION! THERE MAY BE A POSSIBLE SAFETY HAZARD DUE TO
SIMULTANEOUS USE OF THE autoRICTM AND OTHER
PATIENT-CONNECTED MEDICAL ELECTRICAL EQUIPMENT.

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Product Features
The autoRICTM system consists of three (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 ready for use.
CAUTION! USE ONLY CELLAEGIS DEVICES INC. CHARGING CRADLE
(REF: CRG-0001) TO CHARGE THE CONTROL UNIT.
Figure 1: autoRICTM Controller

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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.
The Applicator cuffs are available
in three (3) adult sizes and will
accommodate the following arm
circumferences:
• Adult Small:
8.7–10.3 in (22–26 cm)
• Adult Medium:
10.6–13.9 in (27–34 cm)
• Adult Large:
13.8–17.3 in (35–44 cm)
Figure 2: Applicator Cuff Unfolded
Figure 3: Applicator Cuff Folded

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Charging Cradle
The Charging Cradle is a stand-
alone charger for the control unit.
It uses a standard medical-grade
AC adaptor (Globtek Inc. Power
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 Control Unit inserted into
the Charging Cradle – at right.)
CAUTION! DO NOT PLUG ANY DEVICES OTHER THAN THE CELLAEGIS
autoRICTM CONTROL UNIT INTO THE CHARGING CRADLE.
Figure 4: Charging Cradle
Figure 5: Control Unit in Charging Cradle

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Device Parts
Control Unit
Figure 6: Control Unit Components

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Charging Cradle Components
Figure 7: Charging Cradle Components
Figure 8: International Power Adaptors

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Applicator Cuff Components
Figure 9: Wall-Mount Attachment for Charging Cradle
Figure 10: Applicator Components