CYMEDICA Orthopedics QB1 User manual

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CyMedica QB1®SYSTEM USER’S MANUAL
Read this manual carefully before operating the CyMedica QB1
®
System
Customer Service 1-844-CYM-2014
www.cymedicaortho.com
Please log onto www.cymedicaortho.com for instructional videos related to the
proper use of QB1 system.
QB-0090-016
Rev. D

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Contents
1INTRODUCTION.............................................................................................................4
2INTENDED USE ..............................................................................................................5
3EXPLANATION OF SYMBOLS ..........................................................................................5
3.1 CONTRAINDICATION ........................................................................ 8
3.2 WARNINGS ....................................................................................... 8
3.3 PRECAUTIONS ..................................................................................9
3.4 ADDITIONAL PRECAUTIONS FOR TENS .............................................11
3.5 ADVERSE REACTIONS .....................................................................11
4QB1 SYSTEM COMPONENTS ........................................................................................ 11
4.1 User Interface (UI).......................................................................... 12
4.2 Conductive Garment (NMES mode only)....................................... 13
4.3 Electrodes and Covers.................................................................... 14
4.4 Electrode Gel (Both NMES & TENS modes) ...................................15
4.5 TENS Pod (TENS mode only) ..........................................................15
4.6 QB1 System Replacement Parts..................................................... 16
4.7 NMES Garment Electrodes Replacement Instructions ..................16
5QB1 OPERATING INSTRUCTIONS.................................................................................. 18
5.1 Charging the User Interface (UI) .................................................... 18
5.2 Wearing the Conductive Garment- NMES Treatment ...................19
5.3 Operating the QB1 Device- NMES Treatment................................21
5.4 Operating the QB1 Device- TENS Treatment .................................23
5.4.1 Wearing the TENS Electrodes ........................................................23
5.4.2 Operating QB1 Device for TENS Treatment...................................24
6QB1 SYSTEM TROUBLESHOOTING ............................................................................... 24
7CUSTOMER SERVICE & MAINTENANCE ........................................................................ 28
7.1 Customer Service ...........................................................................28
7.2 Repair .............................................................................................28
7.3 Cleaning and Maintenance ............................................................28
7.4 Operating Conditions .....................................................................29
7.5 Transportation and Storage conditions .........................................29

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7.6 Shelf life or Use By Date information.............................................29
7.7 Expected service life and disposal information .............................30
7.8 Replacement parts ordering information ......................................30
7.9 Limited warranty............................................................................30
8TECHNICAL SPECIFICATIONS ........................................................................................ 31
8.1 Waveform Information ..................................................................31
8.2 Compliance Declaration.................................................................35
8.3 Guidance and Manufacturer’s
Declaration – Electromagnetic
Emissions .........................................................................................36
8.4 Measurements Accuracy................................................................40
8.5 Materials Specifications .................................................................40

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1INTRODUCTION
The CyMedica QB1®system is an electrotherapy device with two treatment modes:
neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve
stimulation (TENS). The QB1 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.
The QB1 closed loop system provides strong yet comfortable muscle activation. In
NMES mode, pulses stimulate motor points of target muscles causing a contraction. The
QB1 has two different NMES treatment programs: Post-Operative treatment and
Strength Building. Each program treats atrophy and re-educates muscles.
The QB1 TENS treatment is a safe and effective method of pain relief. In TENS mode,
the system blocks the pain signal sent from nerves in the treated area. This is called the
“Gate Theory” of pain control. Patients with chronic knee discomfort can use the QB1
TENS program for immediate and long-term pain relief.
In NMES mode, the QB1 system consists of a User Interface, universal USB charging
cord, Conductive Garment, NMES electrodes, and electrode gel.
In TENS mode, the QB1 system consists of a User Interface, universal USB charging cord,
TENS pod, and TENS electrodes, and electrode gel.
Read this User 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 practitioner licensed
by the law of the State in which he/she practices to use or order the use of the device.
This product is covered by one or more U.S. Patents, see www.cymedicaortho.com for
details.

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2INTENDED USE
The QB1 System is a multifunctional electrotherapy device with two treatment modes
that allow for neuromuscular electrical stimulation (NMES) and transcutaneous
electrical nerve stimulation (TENS).
The intended use of QB1 NMES device, including any indications for use, is limited to
use in rehabilitation, including providing adjunctive therapy in rehabilitation for medical
purposes.
Indications for Use:
As an NMES device, indications are for the following conditions:
−Relaxation of muscle spasms
−Retardation or prevention of disuse atrophy
−Increasing local blood circulation
−Re-educating muscles
−Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
−Maintaining or increasing range of motion
The QB1 TENS device is intended for pain relief.
As a TENS device, indications are for the following conditions:
−Symptomatic relief and management of chronic intractable pain
−Adjunctive treatment for post-surgical and post-trauma acute pain
.
Use environment
The QB1 system is a prescription device in the USA and is intended for use in accordance
with the directions of a health care provider. The device should be used indoors and may be
used in a health care facility setting or by a patient or lay operator in a home environment.
3EXPLANATION OF SYMBOLS
The following symbols are used in this user manual, and on the device packaging, or on
the device or accessory labeling.

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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
Manufacturing date
ISO 15223-1:2012(E)
5.1.3
Legal Manufacturer name and
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
Temperature Limitation
ISO 7000:2014-0632
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

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Do not tumble dry device
ISO 7000:2014-3109
CE Marking
Medical Device Directive 93/42/EEC
Authorized Representative
ISO 15223-1:2012(E)
5.1.2
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
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
Power ON
IEC 60417.1-2004-5007
Power OFF
IEC 60417.1-2004-5008
Battery charge port
CyMedica Symbol

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Low battery; recharge
battery
CyMedica Symbol
Charged battery
CyMedica Symbol
Electrical stimulation is
being delivered
CyMedica Symbol
Electrical stimulation is OFF
CyMedica Symbol
Information
CyMedica Symbol
SAFETY INFORMATION
3.1 CONTRAINDICATION
•Powered muscle stimulators should not be used on patients with cardiac
demand pacemakers.
3.2 WARNINGS
1. Inspect electrodes before each use. Replace electrodes frequently, when they
begin to get dry, deteriorate, or lose adhesion. Electrodes dryness or poor
contact between the electrodes and the patient’s skin increases the risk of
skin irritation or burns. Electrodes will turn dry after a few weeks of use or
sometimes sooner. Dry electrodes could increase the risk of skin irritation and
burn. In addition, dry electrodes reduce stimulation comfort. Apply the
supplied electrode gel on the treatment area of the skin for reducing skin
irritation and providing more comfort. When the device is not in use, cover
the electrodes with the provided electrode covers to reduce the time before
the electrodes turn dry.
2. The long-term effects of chronic electrical stimulation are unknown.
3. Stimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reflex.
4. Stimulation should not be applied over the neck or mouth. Severe spasm of
the laryngeal and pharyngeal muscles may occur and the contractions may be
strong enough to close the airway or cause difficulty in breathing.
5. Stimulation should not be applied transthoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
6. Stimulation should not be applied transcerebrally.
7. Stimulation should not be applied over swollen, infected, or inflamed areas or
skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
8. Stimulation should not be applied over, or in proximity to, cancerous lesions.

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9. Do not apply stimulation in the presence of electronic monitoring equipment
(e.g., cardiac monitors, ECG alarms), which may not operate properly when
the electrical stimulation device is in use.
10. No modification of this device is allowed.
11. Use this device only with the leads, electrodes, electrode gel, and accessories
recommended by CyMedica Orthopedics indicated in this User’s Manual
document.
12. Do not connect this device to equipment not supplied by CyMedica
Orthopedics.
13. Do not use this device while connected to high frequency surgical equipment.
The simultaneous connection may result in burns at the site of the electrodes
and possible damage to the device.
14. Do not use this device in close proximity (e.g. 1 m) of a shortwave or
microwave equipment. The close proximity may produce instability in device
performance.
3.3 PRECAUTIONS
1. Safety of powered muscle stimulators for use during pregnancy has not been
established.
2. Caution should be used for patients with suspected or diagnosed heart
problems.
3. Caution should be used for patients with suspected or diagnosed epilepsy.
4. Caution should be used in the presence of the following:
a- When there is a tendency to hemorrhage following acute trauma
or fracture;
b- Following recent surgical procedures when muscle contraction
may disrupt the healing process;
c- Over the menstruating or pregnant uterus; and
d- Over areas of the skin which lack normal sensation.
5. Some patients may experience skin irritation or hypersensitivity due to
the electrical stimulation or electrical conductive medium. The
irritation can usually be reduced by using an alternate conductive
medium, or alternate electrode placement.
6. Electrode placement and stimulation settings should be based on the
guidance of the prescribing practitioner.
7. Powered muscle stimulators should be kept out of the reach of
children.
8. Powered muscle stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer.
9. Portable powered muscle stimulators such as QB1 device should not be used
while driving, operating machinery, or during any activity in which involuntary
muscle contractions may put the user at undue risk of injury.

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10. Use of electrodes with an active area less than 16 cm
2
will risk suffering a burn
injury. Caution should always be exercised with current densities more
than 2
mA/cm
2
.
11.
Do not wrap electrode lead wires around your neck and keep them out of the
reach of children. Strangulation may result from entanglement in the electrode
lead wires.
12. Keep this device out of the reach of children.
13. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the
QB1
device and the battery compartment.
14. Do not use the QB1 Conductive Garment in proximity of fire or excessive heat
sources due to the risk of fire. Make sure that the electrodes cover the
connectors on the garment before use to avoid shocking, skin irritation, and
burns.
15. Care should be used to avoid tripping on lead wires.
16. Do not operate this device while charging.
17. Do not disconnect any stimulation cables during a session while the
stimulator is switched on. Switch the stimulator off first. Always turn off the
stimulator before moving or removing any electrodes during a session.
18. Do not apply stimulation in the vicinity of metal. Remove jewelry, body
piercings, buckles or any other removable metallic product or device in the
area of stimulation.
19. Never use the electrodes contra-laterally; i.e., do not use two pins connected
to the same channel on opposite segments of the body.
20. For an effective stimulation and maximum comfort, follow your clinician
instructions or the following guideline for placing the electrodes on the
Conductive Garment (NMES) and Knee Joint (TENS).
21. Hair may be trimmed in vicinity of electrodes for additional comfort.
22. Apply electrode gel on the treatment area of the skin for maximum treatment
effectiveness and comfort.
23. The following equipment or environments could generate enough
electromagnetic interference to potentially create unwanted activation of
your QB1 system. Avoid them if possible.
a. Antennas of citizen band (CB) or ham radios.
b. Electric arc welding equipment.
c. Electric induction heaters.
d. Electric steel furnaces.
e. High-voltage areas (safe if outside the fenced area).
f. Large stereo speakers.
g. Magnets or other equipment that generate strong magnetic
fields.

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h. Microwave communication transmitters (safe if outside the
fenced area).
i. Power lines or power generators.
j. Television and radio transmitting towers (safe if outside the
fenced area).
24. If you suspect that equipment is interfering with the QB1 system, do the
following:
a. Move away from the equipment or object.
b. If possible, turn off the equipment or object,
25. The presence of lint, dust, pets, pests, and children in the operating
environment can impact the performance of the QB1 system. Prior to use,
the system should be inspected for the following:
a. Dust, dirt, lint, or pet hair on the face of the electrode(s). Should
the electrodes pick up small amounts of debris you may use a drop
of water or the electrode gel on your finger to gently rub the debris
off the electrode. Electrodes are reusable as long as they are clean
without any sign of visible damage and still tacky. Replace the
electrodes if they no longer adhere to the skin properly.
b. Damage to User Interface, User Interface cable, or electrode wires
by pests, pets, or children. If there is evidence of damage, the
system should be returned to CyMedica Orthopedics for repair.
3.4 ADDITIONAL PRECAUTIONS FOR TENS
• TENS is not effective for pain of central origin, including headache.
• TENS is not a substitute for pain medications and other pain management
therapies.
• TENS devices have no curative value.
• TENS is a symptomatic treatment and, as such, suppresses the sensation of pain
that would otherwise serve as a protective mechanism.
• Effectiveness of TENS is highly dependent upon patient selection by a practitioner
qualified in the management of pain patients.
3.5 ADVERSE REACTIONS
•Skin irritation and burns beneath the electrodes have been reported with the
use of powered muscle stimulators.
4QB1 SYSTEM COMPONENTS
The QB1 system provides NMES and TENS treatments to prevent or reduce quadriceps
atrophy and to provide pain relief.

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The QB1 NMES system consists of user interface, universal USB charging cord,
conductive garment, extra NMES electrodes set, and electrode gel.
The QB1 TENS system consists of user interface, universal USB charging cord, TENS pod,
TENS electrodes set, and electrode gel.
Note: the QB1 TENS Pod is not included and must be ordered separately from the QB1
NMES system.
4.1 User Interface (UI)
The QB1 UI is the stimulation generator and the control device for the QB1 system. It
sends the selected therapeutic program to the electrodes on the body. The UI utilizes
a touchscreen and tactile buttons for user control.
Battery Charge Port
The universal USB charging cord plugs into the UI Battery Charge Port to
recharge the UI.
In the ON position (I), the Touchscreen will turn on and allow you to
interact with it. In the OFF position (O), the UI will be off and will not
deliver treatment.
On/Off Switch
Battery Charge Port

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Universal USB Charging Cord
The Universal USB Charging Cord should be plugged into a standard 5V USB wall
adapter to charge the UI. A power supply is not provided with the QB1 System.
4.2 Conductive Garment (NMES mode only)
The QB1 Conductive Garment is used to secure the electrodes against
your leg during NMES treatment.
Electrodes with
Electrode Covers

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4.3 Electrodes and Covers
The QB1 uses hydrogel electrodes to deliver the stimulation program
to your leg. The NMES conductive garment employs three electrodes:
two 2" x 3.5" (5 cm x 9 cm) electrodes and one 2" x 2" (5 cm x 5 cm)
electrode. The QB1 TENS employs two 2” x 2” (5 cm x 5 cm)
electrodes.
Electrodes will turn dry after a few weeks of use or sometimes sooner.
Dry electrodes could increase the risk of skin irritation and burn. In
addition, dry electrodes reduce stimulation comfort.
Replace electrodes frequently. When utilizing stimulation at intensity
levels of 60 or higher, replace electrodes more frequently to minimize
risk of skin irritation or burn. Electrodes are reusable as long as they
are clean and without any sign of visible damage, dryness, and still
tacky.
The electrode covers protect the electrodes from debris and damage.
Before treatment, remove covers so the electrodes can contact the
skin. After treatment, place the plastic side of the cover over the
electrode.
NMES Electrodes
TENS Electrodes
Electrode Covers

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4.4 Electrode Gel (Both NMES & TENS modes)
4.5 TENS Pod (TENS mode only): Not included – ordered separately
Electrode gel must be used with each treatment session to maximize
treatment effectiveness and comfort, and minimize adverse effects.
Utilize a small amount of gel to hydrate the skin where the electrodes
will be placed on the leg.
The QB1 TENS Pod is used for delivery of TENS pain management therapy.

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4.6 QB1 System Replacement Parts
Please visit the CyMedica Orthopedics online store at
https://store.cymedicaortho.com/ to order replacement electrodes and supplies.
Contact CyMedica Orthopedics (1-844-CYM2014) if you have any questions about
online ordering.
4.7 NMES Garment Electrodes Replacement Instructions
Your garment is provided with pre-installed electrode wires with protective
caps covering the metal conductive pins. Follow these instructions to
initially place or change your electrodes with a new set. Acquire an
electrode set. If this is the first time you are placing electrodes on your
garment, remove the plastic electrode pin covers. If you are replacing
electrodes already on your garment, gently peel the existing electrodes from
the garment.

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Pull the white wire connected to the electrode out of garment until second
wire (blue, black, red) is exposed. Unplug the white electrode wire. Plug in a
new electrode of the same size (2" x 2" or 2" x 3.5") all of the way so that the
metal pin is completely covered.
Push electrode wire back into garment as far as possible. Rotate electrode so
the black sticky side of electrode is facing up, the hook side is facing down,
and firmly place within the electrode outlines on the garment.

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Remove clear plastic liner from top of electrode. After removing the clear
plastic liner, place the reusable black electrode cover from packaging or the
old electrode and place on the new electrode. Repeat the above steps for
the other two electrodes.
5QB1 OPERATING INSTRUCTIONS
5.1 Charging the User Interface (UI)
When fully charged, the UI can deliver at least three 20-minute treatments.
Caution: Do not operate this device while charging.
When not in use, disconnect the UI from the Conductive Garment and TENS
Pod.
To charge the UI, slide the ON / OFF Switch to the OFF position ( ). The UI
will not charge if the switch is not turned to the OFF position.
Attach the supplied universal USB charging cord to a standard 5V wall adapter
charger. Plug the small, micro USB end of the universal USB charging cord to
the UI Battery Charge Port ( ).

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The battery indicator light will be Blue while battery is charging. The UI and charger
should be positioned so that the AC plug of the charger is accessible.
The UI requires about five hours to fully recharge. Once the charge cycle is complete,
the battery indicator light will turn off. The charger should be only be disconnected
from its power source by removing the AC plug from the wall outlet.
5.2 Wearing the Conductive Garment- NMES Treatment
Note:
Wash and dry skin. Apply a small, pea-sized amount of electrode gel to
electrode area of skin.Remove electrode covers from all
three electrodes.
Sit down with the leg extended. Place the Conductive Garment under the
leg. The blue surface should be against the back of the thigh and the
round cut out behind the knee.
(Note- The pictures shown here are the right leg garment).
Note: Remove the
electrode covers to
expose the VMO, RF, and
Common electrodes.

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4
Wrap the inside flaps over the thigh and calf.
Pull Garment Strap 1 over the thigh flap and attach to the garment as shown.
Pull Garment Strap 2 over the calf flap and attach as shown. Verify the knee
opening fits comfortably around the knee.
Attach Garment Straps 3 and 4 around the leg ensuring a snug but
comfortable fit as shown.
Refer to CyMedica Orthopedics website,
www.cymedicaortho.com for instructions related to the
use of QB1 knee brace.
Electrode Flap
(Inside)
Blue surface (Place
against back of
thigh)
Circular cutout
(Place behind knee)