ZOLL Medical Israel UCOR100 uCOR System Monitor, uCOR v1.0.0 User Manual IFU USA FCCx
Kyma Medical Technologies Ltd. uCOR System Monitor, uCOR v1.0.0 IFU USA FCCx
Contents
- 1. Users Manual
- 2. User Manual
User Manual
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 2351806 |
| Application ID | qGH574u5Q8Gb+riSe9ORSw== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 132.75kB (1659401 bits) |
| Date Submitted | 2014-08-08 00:00:00 |
| Date Available | 2014-08-13 00:00:00 |
| Creation Date | 2014-01-19 15:50:21 |
| Producing Software | PDF Printer / www.bullzip.com / CP / Freeware Edition |
| Document Lastmod | 2014-01-23 16:05:22 |
| Document Title | Microsoft Word - IFU USA FCC.docx |
| Document Creator | UnknownApplication |
| Document Author: | moshik |
User Guide
Kyma Medical Technologies Ltd.
µCor
Non-Invasive Fluid Status Monitor
Kyma µCor
User Guide
Important
This User Guide is subject to periodic review, update and revision.
Do not use a defective product. Do not repair this product or any of its parts other than in
accordance with written instructions provided by Kyma.
The user of this product has sole responsibility for any malfunction that results from improper use,
faulty maintenance, improper repair, unauthorized service, damage, or alteration by anyone other
than Kyma.
The safety, reliability, and performance of this device can only be assured under the following
conditions:
1. The device has been used according to the accompanying operating instructions.
2. All fittings, extensions, readjustments, changes, or repairs have been carried out by Kyma's
authorized representatives.
© Copyright 2012 Kyma Medical Technologies Ltd. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photo reproductive, recording or otherwise without
the express prior written permission of Kyma Medical Technologies Ltd.
Kyma Medical Technologies Ltd. reserves the right to change or improve its products and
accompanying technical literature without specific notice of changes or improvements.
This product is patent protected.
User Guide RA-72-002-008
Revision 3 ∙ May 2013
Kyma Medical Technologies
Atir-Yeda Industry park
17th Atir-Yeda St.
Kfar-Sava 44643, ISRAEL
2nd floor, East Entrance
Tel: +972.72.2119301
Fax: +972.72.2119304
http://www.kyma-
E-mail: info@Kyma-med.com
med.com
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 2
Kyma µCor
User Guide
The symbol CE 0344 indicates compliance of this device with the Medical Device Directives
93/42/ EEC, 2007/47/CE.
MedNet GmbH
Borkstrasse 10,
48163 Münster, Germany;
Tel.: 49-2506-8644-0
Fax: 49-2506-8644-22
Disclaimer
Information provided by Kyma Medical Technologies Ltd. is believed to be accurate and
reliable. However, Kyma Medical Technologies Ltd. assumes no responsibility for the use of
such information, nor for any infringements of patents or other rights of third parties, that may
result from its use.
PLEASE READ THIS USER GUIDE BEFORE
OPERATING THE SYSTEM
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 3
User Guide
Kyma µCor
TABLE OF CONTENTS
Contents
1. Introduction .....................................................................................6
1.1. ABOUT THIS USER GUIDE..................................................................................................................... 6
1.2. GLOSSARY AND ABBREVIATIONS ............................................................................................................ 6
1.3. THE KYMA µCOR SYSTEM..................................................................................................................... 6
2. Conditions for Use ............................................................................7
2.1. INTENDED USE ................................................................................................................................... 7
2.2. INDICATIONS...................................................................................................................................... 7
2.3. CONTRAINDICATIONS .......................................................................................................................... 7
3. Safety ...............................................................................................8
3.1. TYPES OF WARNINGS, CAUTIONS AND NOTES .......................................................................................... 8
3.2. GENERAL SAFETY INSTRUCTIONS ........................................................................................................... 8
3.3. ELECTRICAL SAFETY ............................................................................................................................. 9
3.4. EMC COMPLIANCE............................................................................................................................. 9
4. Overview of System components.................................................... 11
4.1. DEVICE DESCRIPTION ........................................................................................................................ 11
4.2. DIAGRAM OF SYSTEM MAIN COMPONENTS AND COMMUNICATION ............................................................ 11
4.3. CARTRIDGE ..................................................................................................................................... 11
4.4. CHARGER ........................................................................................................................................ 13
4.5. MEDICAL PATCH .............................................................................................................................. 13
4.6. COMPONENTS: SERVER ..................................................................................................................... 15
5. Using the uCor Device ..................................................................... 16
5.1. DETERMINING THE CORRECT LOCATION FOR THE MEDICAL PATCH .............................................................. 16
5.2. APPLYING THE MEDICAL PATCH .......................................................................................................... 16
5.3. REPLACING THE MEDICAL PATCH ......................................................................................................... 17
5.4. CONNECTING THE CARTRIDGE TO THE MEDICAL PATCH ............................................................................ 18
5.5. CHARGING THE CARTRIDGE ................................................................................................................ 18
5.6. REMOVING THE DEVICE CONNECTIONS FROM THE PATIENT ...................................................................... 20
5.7 CLEANING THE CARTRIDGE .................................................................................................................. 20
6. Troubleshooting ............................................................................. 21
7. Cleaning and Maintenance ............................................................. 22
7.1. NOTES ON CLEANING AND MAINTENANCE ............................................................................................ 22
7.2. GENERAL CLEANING PROCEDURES ....................................................................................................... 22
8. Repair policy ................................................................................... 23
9. Storage ........................................................................................... 24
10. System Labels and Symbols .......................................................... 25
10.1. SYSTEM LABELS .............................................................................................................................. 25
10.2. EXPLANATION OF SYMBOLS .............................................................................................................. 27
11. Specifications................................................................................ 28
11.1. SYSTEM ACCURACY ......................................................................................................................... 28
11.2. ENVIRONMENTAL INFORMATION ....................................................................................................... 28
11.3. ELECTRICAL ................................................................................................................................... 28
11.4. CARTRIDGE DIMENSIONS ................................................................................................................. 28
User Guide
Kyma µCor
12. Warranty ...................................................................................... 29
Appendix A: LED Indicator Lights on the Cartridge .............................. 30
Appendix B: Cartridge Battery Maintenance and Care ........................ 31
Appendix C: Hospital Protocol ............................................................ 31
DESCRIPTION: ........................................................................................................................................ 31
TERMS .................................................................................................................................................. 32
PATIENT RECRUITMENT ............................................................................................................................ 32
PATIENT FOLLOW-UP ............................................................................................................................... 33
PATIENT RELEASE .................................................................................................................................... 34
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 5
Kyma µCor
User Guide
1. INTRODUCTION
1.1. ABOUT THIS USER GUIDE
This User Guide provides the information necessary to operate the Kyma µCor
System.
PLEASE READ THIS USER GUIDE BEFORE OPERATING THE SYSTEM. If any part of this
User Guide is not clear, contact Customer Support for assistance.
1.2. GLOSSARY AND ABBREVIATIONS
BT:
Blue Tooth
CHF:
Congestive Heart Failure
ESS:
Electronic Synchronization Signal
GUI:
Graphic User Interface
RF:
Radio Frequency
FS:
Fluid Status
UCID:
Identification number of the
Medical Cartridge
CLOUD: BT TO TCP/IP COMMUNICATION
1.3. THE KYMA µCOR SYSTEM
µCor is a non-invasive, impedance-based device that assesses a patient's Fluid Status
(FS) by measuring the electromagnetic properties of the thorax. The µCor system
consists of the following main parts:
1. Disposable Medical Patch – An adhesive patch with a plastic anchoring frame
and two ESS electrodes. The Cartridge clicks into the plastic frame.
2. Reusable Cartridge – A plastic box which includes the RF bio-impedance sensor,
communication unit, and two additional sensors: Electronic synchronization
signal (ESS) leads and accelerometer. The Cartridge has also a green/amber LED
light indicator.
3. Charger – A charging cradle for recharging the Cartridge battery.
4. Server – Data base application software, used to collect the data, analyze it and
present the data to the user.
This device is intended for use under the direction of a physician, for the non-invasive
monitoring and management of patients with fluid management problems in a
variety of medically accepted clinical applications.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 6
Kyma µCor
User Guide
2. CONDITIONS FOR USE
2.1. INTENDED USE AND INDICATIONS FOR USE
The µCor System is indicated for patients:
•
•
•
•
•
•
•
•
With fluid management problems
Taking diuretic medication
Living with heart failure
Living with end-stage renal disease
Recovering from an event related to coronary artery disease
Suffering from recurrent dehydration
With severe infection (such as sepsis)
With hypertension.
2.2.CONTRAINDICATIONS
The system is not for use by patients:
•
with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive
•
with implanted Neurostimulators
•
with skin breakdown in areas on the chest where electrode device placement is
required.
•
Pregnant women.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 7
Kyma µCor
User Guide
3. SAFETY
3.1. TYPES OF WARNINGS, CAUTIONS AND NOTES
Three types of special message appear in this User Guide:
Warning: A warning indicates precautions to avoid the possibility of
personal injury or death.
Caution: A caution indicates a condition that may lead to damage to
equipment, or a lower quality of treatment.
Note: A note provides other important information.
3.2. GENERAL SAFETY INSTRUCTIONS
Warnings:
DO NOT USE BEFORE READING THIS USER GUIDE.
Remove Cartridge and Medical Patch before external defibrillation or
any emergency medical procedure.
Changes or modifications not expressly approved by Kyma Medical
Technologies Ltd. can affect the safety and effectiveness of the system
and will void the system's warranty.
The system contains no user-serviceable components.
Electrical shock and flammability hazard – Cleaning the device should
be limited to the simple procedure discussed on page 22. For any
additional cleaning or servicing, always consult Kyma Medical
Technologies Ltd.
Electrical shock hazard – Do not remove the cover from any
components of the system. An operator may only perform
maintenance procedures specifically described in this User Guide.
Refer servicing to qualified service personnel trained in the repair of
this equipment.
Electrical shock hazard – Connect this equipment only to a hospitalgrade AC electrical socket.
Electrical shock hazard –Keep any kind of liquid or food away from
the charger
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 8
Kyma µCor
User Guide
Cautions:
Disposal of this device should be performed in accordance with local
regulations.
If the device is not working correctly, discontinue use and contact
Customer Support for assistance.
Do not use this device in the presence of MRI or when entering
extreme heat conditions. (over 50°C)
Do not disassemble any part of the system components. This system is
not user-serviceable.
3.3. ELECTRICAL SAFETY
The device complies with IEC/EN 60601-1 for general requirements of medical electrical
equipment safety:
•
•
•
•
•
Type BF applied part
Mode of operation: spot measurement
Degree of mobility: portable
Compatibility with implanted defibrillators
Compatibility with pacemaker.
3.4. EMC COMPLIANCE
The unit has IEC 60601-1-2 Class B compliance.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 9
Kyma µCor
User Guide
3.5. FCC COMPLIANCE STATEMENT
The FCC Wants You to Know
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
a) Reorient or relocate the receiving antenna.
b) Increase the separation between the equipment and receiver.
c) Connect the equipment to an outlet on a circuit different from that to which
the receiver is connected.
d) Consult the dealer or an experienced radio/TV technician.
FCC Warning
Modifications not expressly approved by the manufacturer could
void the user authority to operate the equipment under FCC Rules.
THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY
UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID
THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 10
Kyma µCor
User Guide
4. OVERVIEW OF SYSTEM COMPONENTS
4.1. DEVICE DESCRIPTION
The Kyma µCor system is an RF-based non-invasive device that assesses and displays a
patient's Fluid Status (FS) trends. The system is intended for use under the direction of a
physician, for the non-invasive monitoring and management of patients with fluid
management problems in a variety of medically accepted clinical applications.
The system can monitor heart rate, respiratory rate and motion level on top of FS.
4.2. DIAGRAM OF SYSTEM MAIN COMPONENTS AND COMMUNICATION
The main components of the Kyma µCor System and their connections are illustrated in the
diagram below:
BT communication
TCP/IP
Communication between device main components
The description of system components is provided in the following sections.
4.3. CARTRIDGE
The Cartridge is a thin, waterproof, reusable plastic housing. It
contains two ESS leads and a LED light. Note that while wearing
the Cartridge the patient can do everyday activities such as
walking or taking a shower. The Cartridge clicks into a disposable
Medical Patch (page 13).
Cartridge
There is a wireless link between the Cartridge and the server.
The Cartridge transmits the data to the Cloud, where the data is sent to the server.
A Bi-Color LED (amber/green) is located close to the center of the Cartridge for status
indications. See Appendix A for a description of the LED indicator light on the Cartridge and
its meaning.
Note: The Cartridge contains a button for technician use only.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 11
Kyma µCor
User Guide
4.3.1. CARTRIDGE FRONT PANEL
The Cartridge front panel contains most of the components that are relevant for the
user. The components are shown below.
Cartridge Front Panel Components
Number
Description
ESS leads (Left and Right)
LED light (Amber/Green)
Technician button
Upper snap in clip
Lower snap in joints
Cartridge front view
Caution: if you experience a problem with the Cartridge, do not use the device.
Call customer support.
Caution: When not in use, the Cartridge must be stored in the Charger.
4.3.2. CARTRIDGE BACK PANEL
The Cartridge back panel contains the following:
Cartridge Back Panel Components
Number
Description
ESS leads (Left and Right)
Upper snap in clip
Lower snap in joint
Cartridge Serial Number
and FCC ID
Cartridge back panel
Caution: Avoid spilling food or liquids on the Cartridge.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 12
Kyma µCor
User Guide
Note: The Cartridge Serial Number (S/N) and FCC ID can be found on the back of the
Cartridge:
S/N DG3212-000-001
FCC ID 2ABHFUCOR100
The cartridge ID
4.4. CHARGER
A dedicated Charger is supplied along with the Cartridge. The Charger is a charging cradle for
recharging the Cartridge battery.
The charger does not contain any LED lights, as battery status is shown on the Cartridge. The
charger is supplied with an AC adapter.
Caution: The Charger has its own AC adapter. Be sure to use only the adapter that is
supplied with the charger.
4.5. MEDICAL PATCH
The adhesive Medical Patch is disposable and intended for one-time use. Although the
Medical Patch is normally worn by the patient continuously, from patient admission to
discharge, it may require replacement under certain circumstances (see page 17).
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 13
Kyma µCor
User Guide
The Medical Patch
consists of a plastic
Frame for the Cartridge
and two ESS electrodes
embedded on each
side of the Frame.
Attachment of the
Cartridge to the Medical
Patch is performed using
a snap-in mechanism,
while attachment of the
ESS leads is done by
clicking in the ESS
electrodes.
Snap-in mechanism
ESS
Electrode
ESS
Electrode
Patch Frame
Medical Patch
The Cartridge is connected to the Frame part of the Medical Patch when patient is admitted,
and disconnected after the patient is released from hospitalization.
Cartridge and Patch, showing Patch Frame
Cartridge attached to the Medical Patch
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 14
Kyma µCor
User Guide
Caution: If you suspect that the Medical Patch may be damaged,
discontinue use and replace with a new Medical Patch. See page 17
for detailed Medical Patch replacement instructions.
Caution: If you are experiencing a problem with the Cartridge or
components, contact Kyma Medical Technologies customer support.
Caution: Monitor the patch location for any irritation or inflammation.
4.6. COMPONENTS: SERVER
The server manages the data received from the Cartridge, using specialized database
software. The server:
•
•
•
Notes changes in the Cartridge status
Downloads data from the Cartridge on a scheduled basis, and
Processes the measured data.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 15
Kyma µCor
User Guide
5. USING THE UCOR DEVICE
Before using the Kyma µCor system, first read the system Contraindications on page 7. If the
patient presents any of the Contraindications, do not use the system.
After you have verified that the Contraindications allow use of the system, prepare the
patient by describing the system and procedure.
5.1. DETERMINING THE CORRECT LOCATION FOR THE MEDICAL PATCH
The Medical Patch should be located at or near the
following desired anatomical location:
• Left (patient side) mid-axillar line at the fifth
intercostal space.
Caution: The Medical Patch should be aligned
with the mid-axillary line.
Location of the Medical Patch
5.2. APPLYING THE MEDICAL PATCH
Cartridge and Medical Patch
Proper attachment of the Patch to the left side
of the patient's chest
Once the correct anatomical location for the Medical Patch is found, proceed as follows to
attach the Medical Patch to the patient:
[1] Turn the Medical Patch so that the word "Kyma" that is printed on the bottom is
pointing in the direction of the patient's legs:
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 16
Kyma µCor
User Guide
[2] Remove the Medical Patch's paper backing.
[3] Attach the Medical Patch. The woven part of the Medical Patch should be flat and
even.
Please note that the Medical Patch is normally worn by the patient from admission until
discharge.
Note: When attaching the medical patch please ensure minimal air bubbles
5.3. REPLACING THE MEDICAL PATCH
After the initial attachment, the Medical Patch should remain in place on the left side of the
patient's body, unless it requires replacement.
It is advised to use water to assist in removing the patch.
The patch should be removed gently. It is recommended to hold the skin with one hand
while using the other hand to detach the patch from the patient's body.
Caution: Replace the old Medical Patch if one of the following conditions occurs:
• Medical Patch is causing discomfort to the patient.
• Medical Patch appears to be soiled.
• Medical Patch is not securely attached to the patient.
• Medical Patch is not smooth and even, or shows other signs of wear.
• The patch Frame part of the Medical Patch is worn, broken or otherwise
unsuitable to providing a secure connection for the Cartridge.
It is recommended to replace the Medical Patch at least every 5 days.
Caution: In order to ensure accuracy in the measurements, the Cartridge (and
therefore the Medical Patch) must be in the same location for all measurements. If
the old Medical Patch requires replacement make sure to relocate the new
Medical Patch at the same location as the old Medical Patch.
Warning: Be careful that removal of the Medical Patch does not harm the skin,
especially for elderly patients.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 17
Kyma µCor
User Guide
5.4. CONNECTING THE CARTRIDGE TO THE MEDICAL PATCH
The Cartridge is attached to the Medical Patch during patient hospitalization for the TFC
measurements. The Cartridge is attached to the patch Frame area of the Medical Patch, as
shown below:
Cartridge and Medical Patch,
showing the patch Frame area of the
Medical Patch
Cartridge attached to the
Medical Patch
Proceed as follows to connect the Cartridge to the Medical
Patch:
1. Place the lower snap in joints of the Cartridge on
the lower part of the patch Frame, pressing first
on the bottom of the Cartridge. Make sure the
lower snap-in joints are between the Frame and
the woven part.
Cartridge located at final
2. While pressing the upper snap in clip, press the
position
rest of the Cartridge onto the Medical Patch.
3. The Cartridge should be firmly attached, and should stay
connected to the Medical Patch without any effort on the part of the patient.
4. Attach the two ESS leads to the two ESS electrodes and make sure they are well
attached.
It is preferable to charge the Cartridge when it is not assigned to a patient, unless it is
assigned and the battery power is low.
Note: When applying the cartridge to a new patient, make sure the previous
patient was released from the GUI application and that a flashing green LED light is
on the Cartridge.
5.5. CHARGING THE CARTRIDGE
It is recommended that the Cartridge will be charged every two days for one hour in order to
maintain adequate battery status.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 18
User Guide
Kyma µCor
In order to charge the Cartridge, remove the device and its connections from the patient.
The Cartridge should be removed from the Medical Patch as follows:
1. Disconnect the two µCor ESS leads from the Medical Patch.
2. Tilt and remove the Cartridge from the Medical Patch while pressing the upper
snap in clip.
3. Place the Cartridge in the charger and
wait for a steady amber LED light.
4. The steady amber light should change to
a steady green light within around one
hour, indicating the device is fully
charged.
Steady amber light
Steady green light
5. Reconnect the Cartridge to the Medical
Patch as described at page 23.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 19
Kyma µCor
User Guide
5.6. REMOVING THE DEVICE CONNECTIONS FROM THE PATIENT
The Cartridge should be removed from the Medical Patch as follows:
1. Disconnect the two µCor ESS leads from the Medical Patch.
2. Tilt and remove the Cartridge from the Medical Patch while pressing the upper
snap in clip.
3. Remove the Medical Patch from the
patient.
4. Place the Cartridge in the charger and
wait for a steady amber LED light. (If no
light appears after 1-2 seconds check
Flashing green light
Steady amber light
troubleshooting table for required actions)
5. If patient is still active, the amber light will change to green after 1-2 hours,
indicating the device is fully charged.
6. If the patient has been discharged, the steady amber light should change to a
flashing green light within around two hours, indicating the device is charged
and ready for a new patient.
Note: A steady (non-flashing) green light means the µCor is still
referenced to the previous patient at the server.
The Cartridge is ready for a new patient only when there is a flashing
green LED light- DO NOT APPLY DEVICE TO A NEW PATIENT UNTIL THIS
INDICATION OCCURS.
The Cartridge should be cleaned and disinfected before using it for a new patient. Please see
cleaning and disinfecting instructions on page 22.
5.7 CLEANING THE CARTRIDGE
After disconnecting the Cartridge from the patient:
•
•
Clean and disinfect the Cartridge, as shown on page 22.
Place the Cartridge in the charger and make sure the LED light is on.
When the green LED light is flashing, the system is ready for a new patient.
(previous patient is released and the battery is fully charged)
Caution: If the green LED light is not flashing, the last active
patient was not yet released from the server.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 20
Kyma µCor
User Guide
6. TROUBLESHOOTING
The following table lists the recommend actions that assist in µCor System troubleshooting.
Condition
Improper
patch
attachment to
skin
Low battery
No LED light
while in
charger
Possible Cause
Recommended Action
Improper patch
attachment
Replace the Patch and re-attach according to
instructions(see page 22)
Disposable patch reuse
Attach only new Medical Patch. Re – using
patches may result in patient cross –
contamination and inaccurate measurements
Cartridge is not
charged
place the Cartridge in the charger
Charger is not
connected to AC
power
Make sure charger is connected to AC power and
amber LED light is on
Charger is not
connected to AC
power
Make sure charger is connected to AC power
System fault
Contact customer support
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 21
Kyma µCor
User Guide
7. CLEANING AND MAINTENANCE
7.1. NOTES ON CLEANING AND MAINTENANCE
The µCor System does not require maintenance or cleaning on a routine basis, except as
suggested in this User Guide. Any other service should only be provided by an authorized
Kyma Medical Technologies Ltd. representative. Failure to do so voids the warranty and may
cause user injury.
Please see Appendix B on page 41 for Cartridge battery maintenance and care.
7.2. GENERAL CLEANING PROCEDURES
Note: . The Medical Patch is normally worn by the patient from admission until
discharge. However, see page 17 for conditions that require replacement of the
Medical Patch.
Caution: The Medical Patch is for one-time use on one patient only. A Medical
Patch that has been used once must be discarded. It cannot be reused. Re – using
patches may result in patient cross – contamination and inaccurate measurements
If you replace the Medical Patch on a patient, please be sure to follow the directions on page
17.
Please observe the following cautions when cleaning the Cartridge:
Caution: Use cleaning solution sparingly. Excessive solution can cause
damage to internal components.
Caution: Contact with solvents can cause severe deterioration of plastic
parts and malfunctioning of the instrument and accessories.
7.2.1. CLEANING THE CARTRIDGE
The plastic and metal outer surface of the Cartridge may be cleaned with a soft, lintfree cloth dampened in a mild soap and water solution or ethyl alcohol (70-85%).
If disinfecting is required, wipe the surface with isopropyl alcohol (IPA), then wipe
with a water-moistened soft cloth.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 22
User Guide
Kyma µCor
8. REPAIR POLICY
When under warranty, repair and service must be performed by Kyma Medical Technologies
Ltd. When the Kyma warranty is not applicable, repairs may be made by Kyma or authorized
representatives.
Warning: Do not remove the covers of the device components. Only perform
procedures specifically described in this User Guide.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 23
Kyma µCor
User Guide
9. STORAGE
Environmental Conditions for Storage and Transportation
Temperature
-20°C to +60°C
Relative Humidity
5% to 93%, non-condensing
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 24
Kyma µCor
User Guide
10. SYSTEM LABELS AND SYMBOLS
10.1. SYSTEM LABELS
System Label
Serial Label
FCC Label
Cradle Label
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 25
Kyma µCor
User Guide
Patch Label
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 26
Kyma µCor
User Guide
10.2. EXPLANATION OF SYMBOLS
The following symbols may appear on the device or shipping materials.
Follow instructions for use
The serial number for this product
Dispose of this product according to local environmental
regulations
Type BF applied part
Date of Manufacture
Do not re-use
Manufacturer
Expiry date
Direct current
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 27
Kyma µCor
User Guide
11. SPECIFICATIONS
11.1. SYSTEM ACCURACY
The overall system accuracy presents an error of less than 25cc fluid at a confidence level of
90%.
11.2. ENVIRONMENTAL INFORMATION
Operating room
temperature
+10 to +35° C (+50 to +95° F)
Relative humidity
10% to 90% non-condensing
11.3. ELECTRICAL
11.3.1. POWER
Cartridge:
Max Power Consumption: 0.85W
Nominal Power Consumption: 0.65W
Max Rating: 4.2V, 0.2A
Nominal Rating: 3.7V, 0.18A
Battery Type: Li-Pol, 3.7V, 350mAh
Charger:
Consumption during charging: 1W
Input (plug): 5VDC, 0.4A
Adaptor:
Input: 100 to 240 VAC at 50/60Hz; 0.18A
Output: 5VDC; 0.6A
11.4. CARTRIDGE DIMENSIONS
• Height: 60.5 mm
• Width: 99 mm
• Depth: 15.9 mm
• Weight: maximum of 62 gram
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 28
User Guide
Kyma µCor
12. WARRANTY
Service Support
Repairs of the µCor System under warranty must be made by authorized repair centers. If
the device needs repair, contact Kyma Medical Technologies Ltd. service department or your
local distributor.
If you need to ship the device, pack the device and its accessories carefully to prevent
shipping damage.
Duration
Kyma Medical Technologies Ltd. will repair or replace, at its sole discretion, the product or
any defective part, provided it is returned to Kyma service within 30 days.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 29
Kyma µCor
User Guide
APPENDIX A: LED INDICATOR LIGHTS ON THE CARTRIDGE
The table below describes the Cartridge LED lights
indications. The LED is a two-color (green/amber), single
element light.
Cartridge, showing amber LED Light
GENERAL LED LIGHT NOTES:
•
•
•
•
When the Cartridge is out of the charger there is no light
When the Cartridge is placed in the charger the light will be on (see table below for
options)
Green light means battery is fully charged
Amber light means battery is being charged.
LED Constant/Flashing
LED Color
Green
Amber
Constant LED light
Active patient
(the Cartridge placed in
charger during patient
admission and is fully
charged)
Cartridge is being charged
Flashing LED light
Previous patient is released
and Cartridge is ready for a
new patient
(the Cartridge placed in
charger is fully charged)
Error, if repeats more than
once contact Kyma
Note: Only when the flashing green LED light is on, the battery is full and the
Cartridge is ready for a new patient.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 30
User Guide
Kyma µCor
APPENDIX B: CARTRIDGE BATTERY MAINTENANCE AND CARE
The Li-Pol battery used in the Cartridge will provide optimum life when the unit is fully
charged every two days and after each patient release.
With the battery fully charged, the device can operate for about four days assuming
measurement every two hours. Operation times may vary according to the measurement
schedule and battery retention.
A depleted battery requires up to 120 minutes of continuous charge time to fully charge.
Time between charging operations depends on measurement scheduling, for example:
If scheduling 4 measurements per day of 1 minute each, device should be charged
once a week.
If scheduling a 1 minute measurement every 2 hours, device should be charged
every 2-3 days.
Battery life varies depending on frequency of use and maintenance. For improved battery
life, keep the Cartridge in the charger when not in use. If the battery has been fully charged
and requires recharging after a few measurements, consider contacting customer service.
FOR OPTIMAL BATTERY PERFORMANCE:
•
•
•
•
•
•
•
Always fully charge battery prior to assigning a new patient.
Put the Cartridge in the charger when not in use.
Connect the charger only to an AC power source that is supplied with the charger
and wait for the amber LED light to change to green.
Operate the Cartridge, charge batteries, and store at room temperature (25 °C / 77
°F).
If the µCor system is not in use for more than a week, fully charge the battery prior
to using the Cartridge.
Repeated undercharging of the battery will damage the battery and reduce battery
life.
A fully charged Cartridge battery stored outside the charger will need to be
recharged every six months. If the Cartridge battery is not charged every three
months it will be damaged. A depleted battery will not perform as expected after a
full recharge and will eventually require replacement.
APPENDIX C: STUDY PROTOCOL
DESCRIPTION:
uCor device is used supervised by Kyma field technician. Technician is responsible for all maintenance
operations: charging, adhesive patch replacement, device removal & attachment. For each patient
one uCor device is attached. Cellular Gateway (GW) is placed near patient bed. Server monitoring is
performed by experiment supervisor at Kyma, on a daily basis.
Experiment duration: from admission until discharge and no longer than two month.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 31
Kyma µCor
User Guide
TERMS
F.T – Field Technician
E.S. – Experiment Supervisor
PATIENT RECRUITMENT
Step
Title
Device
Attachment
E.S Action
F.T Action
Verify that LED is blinking green
when device is in charger ("ready for
new patient").
Attach the device to the patch.
Attach the Patch to the patient's
chest; Inform E.S by e-mail that a
new patient had been recruited
(report: time of patch attachment,
device Index).
Recruitment
Form
Website
patient
recruitment.
Fill-in Form A. Send to E.S
Assign a patient ID at
website.
Fill in the patient details
(uCor device Idxs,
patient Idx, GW idx) at
xls table (Use-athospital Device
status.xls).
Observe the first 2-3
measurements and
verify ESS and RF
signals are ok.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 32
Kyma µCor
User Guide
PATIENT FOLLOW-UP
Step
Title
E.S Action
F.T Action
E.S follow-up
Review error page and
measurement results per
patient twice a day and
instruct the technician
accordingly by mail.
(Performed twice a
day)
Fill in the relevant checks at
experiment log.
F.T pre follow-up
Check your mail for instructions
from E.S right before the visit. If
any special instructions appear,
act accordingly. If no special
instructions, proceed according
to next steps
Charging
Remove device from patient and
place in the charger.
Check patch condition- Replace
if not satisfactory (starting to
peel off) or 5 days from last
replacement.
Back to work
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
After LED has turned green,
place device back on patient
(~1-2 hours charging time).
Page 33
Kyma µCor
User Guide
PATIENT RELEASE
Step
Title
Device Removal
Server Release
E.S Action
F.T Action
Take off patch and Cartridge,
collect the GW.
Verify all measurement had
been downloaded from uCor
to server PRIOR to releasing
the patient.
Place cartridge in charger and
inform E.S of patient release by
e-mail.
Perform release procedure at
server.
Place device, charger & GW at
storing room, connected to
chargers.
© 2012 Kyma Medical Technologies Ltd. µCor V.1.0.0
Page 34
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : Yes Encryption : Standard V2.3 (128-bit) User Access : Print, Extract, Print high-res XMP Toolkit : Adobe XMP Core 4.0-c316 44.253921, Sun Oct 01 2006 17:14:39 Producer : PDF Printer / www.bullzip.com / CP / Freeware Edition Modify Date : 2014:01:23 16:05:22+02:00 Create Date : 2014:01:19 15:50:21+02:00 Creator Tool : UnknownApplication Metadata Date : 2014:01:23 16:05:22+02:00 Document ID : uuid:23278552-836c-11e3-0000-876cb2806987 Instance ID : uuid:cbc1b84a-398c-4420-8d39-9d84d965b027 Format : application/pdf Title : Microsoft Word - IFU USA FCC.docx Creator : moshik Page Count : 34 Author : moshikEXIF Metadata provided by EXIF.tools