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Nalu Medical Nalu Neurostimulation System, Инструкция пользователя по применению

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Nalu User’s Kit Instructions for Use  PN: MA-000007 Rev C 

 

Page 

30

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44

 

 

Adhesive Clip Pack (H200)– # 34005-001 

 

Description:  Clip 

Material:  Polypropylene 

Diameter:  3”/ 76 mm 

 

 

Description:  Adhesive 

Material:  Hydrocolloid 

Weight:  9 g 

   

Adhesive Clip Pack (H300)– # 34005-003

 

Adhesive Clip Pack (H100)– # 34005-002

 

Description:

 

Clip 

Description:  Clip 

Material:  Polypropylene 

Material:  Polypropylene 

Diameter:  3”/ 76 mm 

Diameter:  3”/ 76 mm 

   

   

Description:  Adhesive 

Description:  Adhesive 

Material:  Hydrocolloid 

Material:  Hydrocolloid 

Weight:  9 g 

Weight:  9 g 

   

 

 

 

Relief Belt – # 34007

 

Description:  Belt 

 

Description:  Buckle 

Material:  Neoprene 

 

Material:  Acetal 

Length:  48”/ 122 cm 

 

Weight:  69 g 

   

 

 

 

 

Содержание Nalu Neurostimulation System

Страница 1: ...Nalu Medical Inc Nalu User s Kit Instructions for Use PN MA 000007 Rev C NALU NEUROSTIMULATION SYSTEM USER INSTRUCTIONS FOR USE...

Страница 2: ...urces ISO 15223 1 5 3 2 Keep dry A medical device that needs to be protected from moisture ISO 15223 1 5 3 4 Temperature limit The temperature limits to which the medical device can be safely exposed...

Страница 3: ...nded for continuous operation IEC 60417 5333 Protected against access to certain hazardous parts Protected against solid objects over 12 5mm e g a finger and protected against falling drops of water i...

Страница 4: ...ndications 7 Warnings 8 Precautions 11 Adverse Event Summary 13 Therapy Disc 16 Description 16 Therapy Disc Features 16 Powering ON the Therapy Disc 17 Connecting the Therapy Disc with the Nalu Implan...

Страница 5: ...rger 25 Troubleshooting 25 Safety and Technical Checks 26 Cleaning Your Device 26 Cleaning the Therapy Disc 26 Cleaning the Trial Therapy Disc 26 Therapy Disc Charger and Clip Disposal 26 Environmenta...

Страница 6: ...d medical professionals The Therapy Disc is designed to be worn when stimulation is needed Stimulation programs can be selected and adjusted from the Therapy Disc or a remote control application A Nal...

Страница 7: ...rms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth Low Energy connection Charger The Nalu charger recharges the batteries inside both the Therapy Discs SAFETY I...

Страница 8: ...ury to the user In rare cases as a result of the unexpected changes in stimulation users have fallen down and been injured If you suspect that your Nalu Neurostimulation System is being affected by EM...

Страница 9: ...he Nalu Neurostimulation System with other active implantable or body worn medical devices Malfunction and or damage could occur to either system that could result in harm to the user or other people...

Страница 10: ...off or may cause permanent damage to the Nalu Implantable Pulse Generator particularly if used in close proximity to the device Lithotripsy Electrocautery Do not use monopolar cautery External defibri...

Страница 11: ...elt may cause a fall or strangulation Tampering Do not modify or tamper with any component of the Nalu Neurostimulation System Tampering with the device could result in harm If the device is not worki...

Страница 12: ...Therapy Disc may become more susceptible to damage by immersion Clean the Therapy Disc When needed clean the outside of the Therapy Disc with a damp cloth to prevent dust and dirt Storage Temperatures...

Страница 13: ...location with or without user movement Persistent post surgical pain at hardware implantation sites Seroma or hematoma at surgery sites Spinal cord injury and or compression with subsequent neurologi...

Страница 14: ...n hyperesthesia Change in stimulation that are possibly related to tissue changes around the electrodes shifts in electrode position loose electrical connections and lead or extension fractures which...

Страница 15: ...Nalu User s Kit Instructions for Use PN MA 000007 Rev C Page 15 of 44...

Страница 16: ...s for Use for details Battery life is optimal when the Therapy Disc is placed directly over the implant You are provided with two Therapy Discs in the initial Nalu User s Kit one to be used while the...

Страница 17: ...e the Therapy Disc over the implant 2 Three 3 short beeps will sound when the Therapy Disc connects to the implant NOTE The Therapy Disc starts stimulation at the most recently used program and stimul...

Страница 18: ...cted the green LED will blink four 4 times NOTE The Therapy Disc cycles through the programs in order When the last program is reached the next program will be Program 1 NOTE The maximum number of pro...

Страница 19: ...Short Press on the Down Button 1 green blink per press Stimulation decreased 2 short orange blinks 2 short beeps Minimum stimulation level reached Long Press on the Down Button Dismiss reactivate ale...

Страница 20: ...ions from the H100 Adhesive Clip switch to the H300 Adhesive Clip 34005 003 If the H100 Adhesive Clip is not sticky enough switch to the H200 Adhesive Clip 34005 001 for easier clip removals Preparing...

Страница 21: ...9 Adhesive Wear Time 1 The wear time for the Adhesive Clip varies per activity level and skin type 2 Wear the clip until it feels like it is coming loose or starts to feel uncomfortable Removing the...

Страница 22: ...nger and pull out the device as shown in Figure 13 Wearing the Relief Belt 1 Wear the belt over a thin layer of clothing at your waist Ensure that the belt is positioned so that the Therapy Disc butto...

Страница 23: ...et location 1 Place the device over the implant location over a thin layer of clothing and wrap the strap around your limb 2 Place the strap through the loop and pull the strap to tighten the limb cuf...

Страница 24: ...ring Up the Charger 1 Use only the provided AC DC power supply Plug the power supply in easily accessible socket so that it is easy to disconnect when necessary 2 Connect the USB C cable from the Powe...

Страница 25: ...The stimulation amplitude is set too low Increase the amplitude The Therapy Disc is Unresponsive The Therapy Disc is not powered ON Turn the power ON The Therapy Disc is Unresponsive The Therapy Disc...

Страница 26: ...odic safety checks or maintenance of the Therapy Disc are not required The Therapy Disc contains no user serviceable parts If repair or service is needed contact your clinician or a Nalu representativ...

Страница 27: ...evices Carry this card with you at all times If you move change doctors or lose your card contact Nalu for a replacement card Refer to the contact information at the end of this manual WHEN TO CALL YO...

Страница 28: ...stimulation ID Card 1 MA 000007 Nalu Neurostimulation User Instructions for Use 1 53002 001 Remote App 74002 Nalu Neurostimulation Trial User s Kit 34002 Trial Therapy Disc 2 34007 Relief Belt 1 43001...

Страница 29: ...Weight 100g Trial Therapy Disc 34002 Description Case Material Polycarbonate Acrylonitrile Butadiene Styrene Diameter 3 76 mm Thickness 0 6 15 mm Weight 100g Description Cable Material Polyvinyl Chlo...

Страница 30: ...9 g Adhesive Clip Pack H300 34005 003 Adhesive Clip Pack H100 34005 002 Description Clip Description Clip Material Polypropylene Material Polypropylene Diameter 3 76 mm Diameter 3 76 mm Description Ad...

Страница 31: ...ption Velcro Material Neoprene Material Acetal Length 18 46 cm Weight 33 g Limb Cuff Large 34011 Description Cuff Description Velcro Material Neoprene Material Acetal Length 25 64 cm Weight 40 g Thera...

Страница 32: ...FCC ID 2AAQS ISP1507 Trail Therapy Disc Contains FCC ID 2AAQS ISP1507 Classification per IEC 60601 1 Therapy Disc and Trial Therapy Disc In use Type BF Charging Class II Quality of Service for Wireles...

Страница 33: ...le and cordless telephones and tablets can affect the device Statement of FCC Compliance This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to par...

Страница 34: ...ity Test IEC 60601 Test Level Compliance Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 V Portable and mobile RF communications equipment should be used no...

Страница 35: ...Generators Dual Integrated Model 11002 040 Single Integrated Model 11001 040 Nalu Implantable Pulse Generators Dual Ported Model 11004 002 connected to two 40 cm Nalu Lead Model 12001 040 Single Porte...

Страница 36: ...ve RF coil that includes a knee foot ankle or wrist transmit receive RF coil No part of the implanted Nalu Neurostimulation System may be within one of these transmit receive RF coils Under the scan c...

Страница 37: ...ive transmit receive RF coil Head Brain MRI Examination Figure 1 Head brain MRI examinations are permitted using a 1 5 T or 3 T MRI system and a transmit receive RF head coil No part of the implanted...

Страница 38: ...ser s Kit Instructions for Use PN MA 000007 Rev C Page 38 of 44 Extremity MRI Examinations Patient implanted with Nalu Neurostimulation System Figure 2a 1 5 T or 3 T MR system Transmit receive RF knee...

Страница 39: ...Nalu User s Kit Instructions for Use PN MA 000007 Rev C Page 39 of 44 Transmit receive RF foot ankle coil 1 5 T or 3 T MR system Patient Implanted with Nalu Neurostimulation System Figure 2b...

Страница 40: ...facturer attached to the Nalu Implantable Pulse Generator The risk of performing an MRI examination under those circumstances has not been evaluated and thus may cause harm to the patient and or the c...

Страница 41: ...impedance check Do not perform an MRI if the impedance is greater than 10 k Remove the Therapy Disc from the patient before entering the MRI system room Do not conduct an MRI examination if the 40 cm...

Страница 42: ...coil at 1 5 T or 3 T For head brain MRI examinations only the transmit receive RF head coil is permitted for use No parts of the implanted Nalu Neurostimulation System may be within the transmit recei...

Страница 43: ...ulation System may be within the transmit receive RF head coil Preparation of the Patient Prior to the MRI Examination Inform the patient of the risks associated with undergoing an MRI examination an...

Страница 44: ...ort nalumed com www nalumed com This product can expose you to chemicals including ethylene oxide which is known to the State of California to cause cancer and birth defect or other reproductive harm...

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