CYMEDICA Orthopedics QB1 User Manual
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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
10/2021
QB-0090-016, Rev. D, Page 1 of 40

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Summary of Contents for CYMEDICA Orthopedics QB1

  • Page 1 ® 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 10/2021...

  • Page 2: Table Of Contents

    Operating the QB1 Device- NMES Treatment........ 21 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 6 QB1 SYSTEM TROUBLESHOOTING ................24 7 CUSTOMER SERVICE & MAINTENANCE ................ 28 Customer Service ................
  • Page 3 Shelf life or Use By Date information..........29 Expected service life and disposal information ......30 Replacement parts ordering information ........30 Limited warranty ................30 8 TECHNICAL SPECIFICATIONS ..................31 Waveform Information ..............31 Compliance Declaration ..............35 Guidance and Manufacturer’ s Declaration – Electromagnetic Emissions ..................

  • Page 4: Introduction

    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”...

  • Page 5: Intended Use

    − 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.
  • Page 6 Symbol Description Reference Number for Symbol Reference number; part ISO 15223-1:2012(E) number 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 ISO 15223-1:2012(E) address 5.1.1 Follow instructions for use ISO 7010:2011-M002 Consult instructions for use ISO 7000 Reg No.
  • Page 7 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 Classified ISO 60601-1:2005(E) 9900900, Electronic Testing Lab, indicates product meets US and Canadian product safety standards. This device conforms to AAMI Std. ES60601-1.

  • Page 8: Contraindication

    battery; recharge CyMedica Symbol battery Charged battery CyMedica Symbol Electrical stimulation CyMedica Symbol being delivered Electrical stimulation is OFF CyMedica Symbol Information CyMedica Symbol SAFETY INFORMATION 3. 1 C O N T R A I N D I C A T I O N Powered muscle stimulators should not be used on patients with cardiac •...

  • Page 9: Precautions

    Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. 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.
  • Page 10 12. Keep this device out of the reach of children. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the QB1 device and the battery compartment. Do not use the QB1 Conductive Garment in proximity of fire or excessive heat sources due to the risk of fire.

  • Page 11: Additional Precautions For Tens

    Power lines or power generators. 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: Move away from the equipment or object. If possible, turn off the equipment or object, 25.

  • Page 12: User Interface (Ui)

    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 U s e r I n t e r f a c e ( U I ) The QB1 UI is the stimulation generator and the control device for the QB1 system.

  • Page 13: Conductive Garment (Nmes Mode Only)

    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 C o n d u c t i v e G a r m e n t ( N M E S m o d e o n l y ) The QB1 Conductive Garment is used to secure the electrodes against your leg during NMES treatment.

  • Page 14: Electrodes And Covers

    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.

  • Page 15: Electrode Gel (Both Nmes & Tens Modes)

    T E N S P o d ( T E N S m o d e o n l y ) : N o t i n c l u d e d – o r d e r e d s e p a r a t e l y The QB1 TENS Pod is used for delivery of TENS pain management therapy.

  • Page 16: 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 N M E S G ar m en t El ec tr o d es R ep lac em en t In str u c tio n s Your garment is provided with pre-installed electrode wires with protective caps covering the metal conductive pins.
  • Page 17 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.

  • Page 18: Qb1 Operating Instructions

    Repeat the above steps for the other two electrodes. QB1 OPERATING INSTRUCTIONS 5. 1 C h a r g i n g t h e U s e r I n t e r f a c e ( U I ) When fully charged, the UI can deliver at least three 20-minute treatments.

  • Page 19: Wearing The Conductive Garment- Nmes Treatment

    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.
  • Page 20 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. 10/2021 QB-0090-016, Rev. D, Page 20 of 40...

  • Page 21: Operating The Qb1 Device- Nmes Treatment

    5. 3 O p e r a t i n g t h e Q B 1 D e v i c e - N M E S T r e a t m e n t All electrodes should be in direct contact with the patient skin.
  • Page 22 On the Stimulation Level screen, you set the intensity levels. Each level begins with a setting of 0 and has a maximum setting of 100. Press “+” to increase knee treatment intensity Press “-” to decrease knee treatment intensity NOTE: It is common to have different desired intensity levels for the KNEE AREA and THIGH AREA.

  • Page 23: Operating The Qb1 Device- Tens Treatment

    O p e r a t i n g t h e Q B 1 D e v i c e - T E N S T r e a t m e n t 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.

  • Page 24: Operating Qb1 Device For Tens Treatment

    5.4.2 Operating QB1 Device for TENS Treatment Note: The QB1 TENS Pod must be ordered separately for operation of TENS mode. Connect the User Interface to the TENS Pod by connecting the UI cable to the socket on the TENS Pod.
  • Page 25 Attention: See Instructions for Use. The UI will display this screen when an error within the QB1 System exists. Should this screen appear, all stimulation will halt immediately. To receive additional treatment, the error must be addressed and the UI power switch must be turned off and on.
  • Page 26 Troubleshooting Table Problem Possible cause Solution Check the UI Cable Loose connection connection to NMES or TENS receptacle Battery discharged Recharge UI The User Interface (UI) is not responding Verify the connection of Bad connection lead wires to electrodes Replace the defective Defective electrode electrodes UI display does not...
  • Page 27 Reposition electrodes. Improper electrode placement Ensure all electrodes are at Stimulation is least 1 inch apart. ineffective Electrode covers are in place over Remove all electrode electrode(s) covers prior to treatment. Reposition electrodes. Improper electrode placement Ensure all electrodes are at least 1 inch apart.

  • Page 28: Customer Service & Maintenance

    Do not attempt to repair any part of the CyMedica QB1 System. Never dismantle the QB1 UI due to risk of electric shock. CyMedica Orthopedics, Inc. declines all responsibilities for any damages or consequences resulting from unauthorized attempts to open, modify, or repair the stimulator.

  • Page 29: Operating Conditions

    S h e l f l i f e o r U s e B y D a t e i n f o r m a t i o n The shelf life or Use By Date requirement applies only to the electrodes and electrode gel. The shelf life of the electrodes and electrode gel are specified on the QB1 system package label.

  • Page 30: Expected Service Life And Disposal Information

    E x p e c t e d s e r v i c e l i f e a n d d i s p o s a l i n f o r m a t i o n The QB1 UI, NMES Conductive Garment, and TENS are expected to provide at least one year of normal use.

  • Page 31: Technical Specifications

    TECHNICAL SPECIFICATIONS 8. 1 W a v e f o r m I n f o r m a t i o n NMES Waveforms POST-OP Treatment Program Name POST-OP Pulse shape Monophasic Treatment duration 20 minutes Frequency 50 pps Pulse width 5 ms Duty cycle...
  • Page 32 TENS Waveforms Treatment Program Name TENS Pulse Shape Biphasic, Symmetrical Treatment Duration 30 minutes Frequency 100 pps Pulse width 1 ms per phase Duty cycle Work cycle Continuous Interphase interval time 4 ms NMES Waveforms TENS Waveforms Full output, Voltage across 500Ω load Full output, Voltage across 500Ω...
  • Page 33 Full output, Voltage across 10,000Ω load Full output, Voltage across 10,000Ω load Rated Outputs – POST-OP NMES Parameter 500 Ω 2 kΩ 10 kΩ Output Voltage (V 9.2 V 16.4 V 21.3 V Output Voltage (V 64 V 96 V 111 V PEAK Output Current (I...
  • Page 34 Rated Outputs – TENS Parameter 500 Ω 2 kΩ 10 kΩ Output Voltage (V 10.9 V 17.9 V 21.7 V Output Voltage (V 37 V 52 V 59 V PEAK Output Current (I 21.9 mA 9.0 mA 2.2 mA Output Current (I 75 mA 26 mA 6 mA...

  • Page 35: Compliance Declaration

    8. 2 C o m p l i a n c e D e c l a r a t i o n IEC 60601-1:2012, 3rd Edition Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2: 2014, 4th Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and...

  • Page 36: Guidance And Manufacturer' S Declaration - Electromagnetic Emissions

    GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS QB1 is intended for use in the electromagnetic environment specified below. The customer or user of the QB1 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guide Group 1 The QB1 uses RF energy only for its internal function.
  • Page 37 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY QB1 is intended for use in the electromagnetic environment specified below. The customer or user of the QB1 should assure that it is used in such an environment Test level Compliance level Electromagnetic...
  • Page 38 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The QB1 is intended for use in the electromagnetic environment specified below. The customer or the user of the QB1 should assure that it is used in such an environment. IEC 60601 test...
  • Page 39 If the measured field strength in the location in which the QB1 device is used exceeds the applicable RF compliance level above, the QB1 device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re orienting or relocating the QB1 device.

  • Page 40: Measurements Accuracy

    Conductive Garment: Inner fabric laminate: Spandex, foam, and silicone. NMES and TENS electrodes: Conductive silicon rubber layer (skin contact) and a conductive hydrogel layer (fabric contact) NOTE: The QB1 Conductive Garment and NMES / TENS electrodes are “not made with natural rubber latex”. CyMedica Orthopedics...

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