CYMEDICA Orthopedics IntelliHab User manual

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CyMedica Orthopedics®
IntelliHab™ System User’s Manual
Read this manual carefully before operating the IntelliHab System
Customer Service 1-844-CYM-2014
Please visit www.cymedicaortho.com for more information on the IntelliHab System.
IH-0090-001
Rev. L

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Contents
1. INTRODUCTION ...................................................................................5
2INTENDED USE AND INDICATIONS FOR USE .........................................5
3. SAFETY INFORMATION ........................................................................7
3.1 EXPLANATION OF SYMBOLS ......................................................7
3.2 DEFINITIONS............................................................................10
3.3 CONTRAINDICATION ...............................................................11
3.4 WARNINGS..............................................................................11
3.5 PRECAUTIONS .........................................................................13
3.6 ADVERSE REACTIONS ..............................................................15
4. IntelliHab SYSTEM COMPONENTS......................................................15
4.1 IntelliHab Controller................................................................16
4.2 Range of Motion Sensor Pod...................................................18
4.3 Conductive Garment ...............................................................18
4.4 Electrodes and Covers .............................................................18
4.5 Electrode Gel...........................................................................19
4.6 IntelliHab System Replacement Part Numbers........................20
4.7 Conductive Garment Electrodes: Placement Instructions........20
5. IntelliHab OPERATING INSTRUCTIONS ...............................................22
5.1 Charging and Storing the IntelliHab Controller ........................22
5.2 Wearing the IntelliHab Conductive Garment...........................23
5.3 Operating the IntelliHab Device for NMES Treatment .............25
5.4 Operating the IntelliHab device as a bilateral system (2
garments and one controller)........................................................31

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5.5 Performing a Range of Motion Test.........................................31
6. WHEN TO USE YOUR IntelliHab SYSTEM ............................................34
7. IntelliHab SYSTEM TROUBLESHOOTING: ............................................34
8. LIST OF ERROR MESSAGES .................................................................37
9. CUSTOMER SERVICE & MAINTENANCE ..............................................37
9.1 Customer Service ....................................................................37
9.2 Repair......................................................................................38
9.3 Cleaning and Maintenance......................................................38
9.4 Operating Conditions ..............................................................39
9.5 Transportation and Storage Conditions...................................39
9.6 Shelf Life or Use By Date Information......................................39
9.7 Expected Service L i fe and Disposal Information ....................39
9.8 Replacement Parts Ordering Information................................40
9.9 Limited warranty.....................................................................40
10. YOUR IntelliHab MOBILE APP AND DATA SECURITY
PRECAUTIONS....................................................................................40
10.1 Required mobile device characteristics & internet..................40
10.2 Mobile app updates ................................................................42
10.3 Additional IntelliHab mobile app security measures ...............42
10.4 Your healthcare provider viewing of your IntelliHab app data
42
10.5 Data security precautions........................................................43
PHYSICIAN INFORMATION......................................................................44
11. CLINICAL STUDY SUMMARY Pivotal USA Trial....................................45

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12.TECHNICAL SPECIFICATIONS ..............................................................54
12.1 Waveform Information ...........................................................54
12.2 Compliance Declaration ..........................................................56
12.3 Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions ......................................................................................56
12.4 FCC and IC ...............................................................................62
12.5 Wireless Quality of Service and Coexistence ...........................63
12.6 Recommendations for Safe Wireless Connections...................64
12.7 Wireless Connections Troubleshooting ...................................64
12.8 Measurements Accuracy .........................................................65
12.9 Materials Specifications...........................................................65

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1 INTRODUCTION
The CyMedica Orthopedics IntelliHab System is a remote patient
monitoring muscle stimulator (or Neuromuscular Electrical
Stimulation/NMES therapy) and digital goniometer device for knee
osteoarthritis pain relief and joint function improvements. The IntelliHab
System is a prescription device in the USA and is intended for use under
the direction of a medical provider. The device may be used in a health
care facility setting or by a patient at home.
Read this User’s Manual carefully before using the device. Pay attention
to the Safety Information and Warnings throughout the manual.
Caution: Federal law restricts this device to sale by or on the order of a
practitionerlicensed bythelaw oftheState in which he/shepractices touse
or order the use of the device.
This productis covered byoneor moreU.S.Patents, see
www.cymedicaortho.com for details.
2INTENDED USE AND INDICATIONS FOR USE
Intended Use:
The IntelliHab system is intended for strengthening of the muscles by
application of neuromuscular electrical stimulation (NMES) therapy.
Indications for Use:
The IntelliHab system is intended to strengthen the quadricep muscle
using powered muscle stimulation to provide symptomatic temporary
pain relief associated with knee osteoarthritis and improvement of the
knee joint mobility when the recommended treatment regimens are
followed.
In addition, the IntelliHab System is indicated for the following:
1. Retardation or prevention of disuse atrophy
2. Evaluation of joint mobility by measuring and recording rangeof
motion
The IntelliHab System is indicated for adults of 22 years of age and older.

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Use environment
The IntelliHab system is a prescription device in the USA and is intended
for use in accordance with the directions of a healthcare provider. The
device may be used in a healthcare facility setting or by a patient or lay
operator in a home environment.

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3SAFETY INFORMATION
3.1 EXPLANATION OF SYMBOLS
The following symbols are used in this user’s manual, and on the device
packaging, or on the device or accessory labeling.
Symbol
Description
Reference Number for
Symbol
Reference number; part number
ISO 15223-1:2012(E)
5.1.6
Lot number
ISO 15223-1:2012(E)
5.1.5
Serial Number
ISO 7000:2014-2498
Manufacturing date
ISO 15223-1:2012(E)
5.1.3
Legal Manufacturer nameand address
ISO 15223-1:2012(E)
5.1.1
Follow instructions for use
ISO 7010:2011-M002
Consult instructions for use
ISO 7000 Reg No. 1641
Expiration date
ISO 15223-1:2012(E)
5.1.4
The system is provided Non Sterile
ISO 15223-1:2012(E)
5.2.7
Prescription only (USA)
FDA General Guidance
Device Labeling
– FDA 89-4203
Minimum and maximum operating
range temperature range
ISO 15223-1:2012(E)
5.3.7
Humidity Limitation
ISO 7000:2014-2620

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Temperature Limitation
ISO 7000:2014-0632
Pressure Limitation
ISO 7000:2014-2621
Keep the device away from sunlight
ISO 15223-1:2012(E)
5.3.2
Keep the device dry
ISO 15223-1:2012(E)
5.3.4
Do not iron device
ISO 7000:2014-3113
Do not machine wash device
ISO 7000:2014-3123
Do not use bleach to clean device
ISO 7000:2014-3124
Do not tumble dry device
ISO 7000:2014-3109
Do not dry clean
ISO 7000:2014-3114
ETC Classified C US, 9900900, Electronic Testing
Lab, indicates product meets US and Canadian
product safety standards. This device conforms
to AAMI Std. ES60601-1. Certified to CAN/CSA
Std. C22.2#60601-1
ISO 60601-1:2005(E)
Attention – consult instructions for
use
ISO 15223-1:2012(E)
Caution
ISO 15223-1:2012(E)
5.4.4
IP20
Protection against medium-sized
foreign bodies with a diameter > 12
mm
IEC 60529
Edition 2.1 2001-
02
IP02
Protection against vertically falling
water drops when enclosure tilted up
to 15°
IEC 60529 Edition 2.1
2001-02

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IP22
Protection against medium-sized
foreign bodies with a diameter > 12
mm; Protection against vertically falling
water drops when enclosure tilted up
to 15
°
IEC 60529 Edition 2.1
2001-02
Type BF applied parts
IEC 60417.1-2004-5333
Lead wires comply with the
performance standard for electrode
lead wires (21 CFR part 898)
IEC 60417.1-2004-5035
Product contains electrical and
electronic equipment. User should
not discard this product along with
other household waste; it must be
collected and treated separately.
Directive 2016/19/EU
Wireless
ISO 7000:2014-3600
Bluetooth Low Energy
IEEE 802.15.1-2005

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3.2 DEFINITIONS
• Applied Parts – Part of the medical equipment, which is
designed to come into physical contact with the patient, or parts
that are likely to be brought into contact with the patient. For
example, the electrodes are an example of an applied part.
• Chronic – persisting for a long time or constantly recurring.
• Carotid sinus nerves - a small but richly innervated arterial
enlargement that is located near the point in the neck where
either carotid artery divides to form its main branches and that
functions in the regulation of heart rate and blood pressure.
• Carotid sinus reflex - is defined by a slowing in heart rate ofmore
than 50 percent or a decline in systolic pressure by more than 40
mmHg during carotid sinus massage.
• Laryngeal muscles – muscles of the larynx
• Pharyngeal muscles – group of muscles that form the pharynx,
which is posterior to the oral cavity.
• Phlebitis – inflammation of the walls of a vein
• Thrombophlebitis - is an inflammatory process that causes a
blood clot to form and block one or more veins, usually in your
legs.