beijing pins medical co., ltd. patient manual manual.pdf · for deep brain stimulation beijing pins...

for Deep Brain Stimulation

Beijing PINS Medical Co., Ltd.

Patient Manual

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Beijing PINS Medical Co., Ltd.

Building No.19 YunguPark,No.79 Shuangying West Road, Technology Park,Changping District,Beijing, China

102200

Address:

Postcode:www.pinsmedical.com

[email protected]:E-mail:

Welcome to use Deep Brain Stimulation(DBS) therapy. Brain pacemaker, developed by Tsinghua University and produced by Beijing PINS Medical Co., Ltd. will be more suited to you. Wish you pace a better life after using PINS brain pacemaker.

Your patient manual, which includes some important information such as guide for postoperative recovery, daily life and so on, is designed to learn about PINS deep brain stimulation system.

2.Postoperative Precautions

1.1.Safety of DBS therapy

1.2.Reliable brain pacemaker1.3.Multiple therapy regimens

2.1.Healing of surgical incision

2.2.Avoid infection of incision

2.3.Signs of infection

2.4.Medication

3.1.Efficacy of PINS DBS

3.2.Turn on DBS therapy

3.3.Program precatuions

3.4.Regular follow-up

3.5.Side effects

4.1.Routine medical examinations

5.1.Introduction to patients’ identification card

5.2.Complications

4.2.Medical contraindication

2.5.Other considerations needing attention

1.Introduction to PINS DBS

3.Efficacy and Improvement of PINS DBS

4.PINS DBS and Medical Examinations

5.Daily Life Guide for PINS DBS

CONTENTS

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9.1.What is the maximum value of brain pacemaker parameters?

9.2.Which factors will affect the battery status of brain pacemaker?9.3.Why are patients with DBS prevented from electromagnetic fields?

9.4.Can I use domestic appliances?

9.5.Which equipment may have EMI? How can I prevent EMI?

9.6.Which equipment or environment should I keep away from?9.7.Can I have a perm or dye hair?

9.8.Can I have MRI examination?

9.9.Can I have X-ray imaging examination?

9.10.Can I have diagnostic ultrasound?

9.11.Can I have routine imaging examination?

9.12.Can I have dental check-up and use dental bur?9.13.Can I have radiation therapy?9.14.Can I have high intensity ultrasound or lithotripsy?

9.15.Can I have laser therapy?9.16.Can I have general surgery?

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5.3.Considerations

6.1.Battery life expectancy

6.2.Replacement of neurostimulator

6.2.Replacement of neurostimulator

5.4.Electromagnetic interference (EMI)

6.Battery Replacement and Wireless Charging of PINS DBS

7.Brain Pacemaker and Patient Controller

9.Frequently Asked Questions about PINS DBS

8.Troubleshooting

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10.Glossary of Terms

11.Parkinson Disease Diary

12.Multifunctional Dag

9.17.Can I implant other medical devices?

9.20.Can I have radiofrequency ablation or microwave ablation?

9.21.Can I use bone growth stimulators?

9.22.Can I use eranscuataneous electrical nerve stimulation (TENS)?

9.23.Can I take a flight for a long duration?

9.24.Will security doors or metal detectors interfere with my DBS system?

9.25.Can I drive a automobile?

9.26.Can I have hot shower, spa or sauna?

9.27.Can I use sunbathing?

9.28.What kind of exercise I should avoid?

9.29.What should I pay attention to before travelling?

9.30.Can I dive or use hyperbaric oxygen chamber?

9.31.Can I have parachute jumping?

9.32.Can I ski or hike?

9.33.Can I be near electric substations or power lines?

9.34.Can I weld?

9.35.Can I work on an automobile?

12.1.Diagram of bag

12.2.Diagram of rain cover

9.19.Can I have electrical stimulation(or magneticstimulation) to treat mental diseases?

9.18.Can I use external defibrillation if I have atrial fibrillation or ventricular fibrillation?

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Information for Patients

Welcome to receive PINS Deep Brain Stimulation (DBS) therapy. Please read this manual and follow the instructions.

Read this manual with your family is recommended.

Deep brain stimulation system implanted in your body mainly includes the neurostimulator (pulse generator), the lead and the extension.

Pay attention to the post-operative recovery and abnormal signs.

Contact your doctor for turn on or off and program your neurostimulatior for further treatment according to your needs.

Tell your doctor in advance that you have implanted neurostimulator when visiting your doctor.

Keep calm and away from electromagnetic interference environment which may cause your discomfort in daily life.

Keep regular follow-up to ensure long-term optimal therapy.

Pay attention to the battery status of your neurostimulator and contact your doctor to perform a replacement surgery before the battery is completely discharged.

Programming and medications management:proper stimulation parameters and medication selection is the key for long-term optimal efficacy of DBS;

Proper psychological counseling and rehabilitation therapy: positive mentality is beneficial to delay the development of PD.

2. Family support and patients’determination are effective weapons to fight disease.

Positive mentality;

Good communication with your doctor about your condition;

Adhere to treatment;

Help patients restore confidence and do rehabilitation

exercise;

Spiritual comfort and good care of daily life from family

will relieve PD patients’ mental pressure and restore

confidence to life.

Thanks for your good care to patients and choose the most advanced therapy to relieve patients’ pain and improve their quality of life.

1. Key factor for successful DBS surgery

Differing from surgeries for the treatment of tumor and cerebrovascular diseases, DBS is mainly used for the treatment of movement disorders, such as Parkinson disease (PD). DBS is a newly comprehensive therapy in order to ameliorate patients’ motor function and improve their quality of life. For PD patients who choose DBS, whether the surgery will be successful or not is determined by the following factors:

Correct preoperative evaluation and diagnosis: it’s aprerequisite for successful DBS surgery. Incorrect diagnosis of disease type will decrease therapeutic effect;

Accurate surgical positioning and operation: accurate target positioning is the foundation of successful DBS surgery;

Good postoperative recovery: poor postoperative recovery may result in the failure of surgery and delay to turn on DBS therapy;

Information for Family Members or Caregivers

Programming and medications management:proper stimulation parameters and medication selection is the key for long-term optimal efficacy of DBS;

Proper psychological counseling and rehabilitation therapy: positive mentality is beneficial to delay the development of PD.

2. Family support and patients’determination are effective weapons to fight disease.

Positive mentality;

Good communication with your doctor about your condition;

Adhere to treatment;

Help patients restore confidence and do rehabilitation

exercise;

Spiritual comfort and good care of daily life from family

will relieve PD patients’ mental pressure and restore

confidence to life.

Thanks for your good care to patients and choose the most advanced therapy to relieve patients’ pain and improve their quality of life.

1. Key factor for successful DBS surgery

Differing from surgeries for the treatment of tumor and cerebrovascular diseases, DBS is mainly used for the treatment of movement disorders, such as Parkinson disease (PD). DBS is a newly comprehensive therapy in order to ameliorate patients’ motor function and improve their quality of life. For PD patients who choose DBS, whether the surgery will be successful or not is determined by the following factors:

Correct preoperative evaluation and diagnosis: it’s aprerequisite for successful DBS surgery. Incorrect diagnosis of disease type will decrease therapeutic effect;

Accurate surgical positioning and operation: accurate target positioning is the foundation of successful DBS surgery;

Good postoperative recovery: poor postoperative recovery may result in the failure of surgery and delay to turn on DBS therapy;

1. Introduction to PINS Deep Brain Stimulation (DBS)

1.1 Safety of DBS therapy

Differing from ablation procedure and medication treatment, Deep Brain Stimulation (DBS) has the advantages of reversibility, no drug resistance and little side effects.

PINS DBS sends electrical pulses, to specific parts of the brain (subthalamic nucleus) through implanted electrodes to modulate and control abnormal cerebral neural activities with the aim to relieve and/or control symptoms and improve patients’ quality of life.

Patients with Parkinson’s disease (PD) often have difficulty controlling their symptoms with medication.PINS DBS has proven very effective in helping PD patients gain control of their symptoms and improve their quality of life. If you have behaviors that may affect efficacy of PINS DBS, you may come back to preoperative condition once you stop using PINS DBS.

1.2 Reliable brain pacemaker

PINS DBS is developed by a research team from National Engineering Laboratory for neuromodulation technology,

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Tshinghua University.Each of brain pacemaker has received reliability test for hundreds of times. The DBS system consists of three components: the implanted neurostimulator (pulse generator), the lead and the extension.

Neurostimulator--a battery-powered neurostimulator encased in a titanium housing, which can be programmed with optimal parameters for you to perform electrical stimulation. Neurostimulator is placed subcutaneously below the clavicle during the surgery.

Lead--The lead is a coiled wire insulated in polyurethane with fourtiny platinumiridium electrodes and is placed in the optimal target site for brain stimulation.

Extension--The extension, connected with the neurostimulator and the lead, is placed below subcutaneous fatty layer of neck. The extension can conduct the electrical pluses produced by neurostimulator to electrodes.

Lead

Extension

Neurostimulator Neurostimulator

Extension

Lead

Bilateral implantation of single-channel brain pacemaker

Implantation of dual-channels brain pacemaker

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1.3 Multiple therapy regimens

Unilateral implantation of single-channel brain pacemaker -- low cost, simple and effective, with an average life expectancy of 5-9 years.

Bilateral implantation of single-channel brain pacemaker -- phase implantation according to disease progression, with an average life expectancy of 5-9 years.

Implantation of dual-channels and non-rechargeable brain pacemaker -- Comprehensively modulations, with an average life expectancy of 4-6 years.

Implantation of dual-channels and rechargeable brain pacemaker -- permanent efficacy and convenient maintenance, with an average life expectancy of 10 years.

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2. Postoperative Precautions

2.1 Healing of surgical incision

For the difference of therapy regimens and physical condition, you will have different number of incisions:

One to two incisions in head for the implantation of the lead;

One to two vertical incisions behind the ear for the implantation of the extension;

One to two transverse incisions near the clavicle for the implantation of the neurostimulator.

Within one week after surgery, discomfort of skin will occur near the surgical incision. Under normal circumstances, redness and swelling of skin may occur and a little tissue fluid may spill.

Following one to two weeks after surgery, the suture will be removed with the incision healing well. Your doctor will check

The potential risks of PINS DBS during the surgery is different for according to patients’ age, physical condition and health condition. If you want to know details, please contact your doctor.

and evaluate whether you have complications. You can leave the hospital and return home if being in good recovery condition.

Following two to six weeks after surgery,the site where the neurostimulator implanted may have sense of pain which will disappear gradually.

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For the difference of therapy regimens and physical condition, you will have different number of incisions:

One to two incisions in head for the implantation of the lead;

One to two vertical incisions behind the ear for the implantation of the extension;

One to two transverse incisions near the clavicle for the implantation of the neurostimulator.

Within one week after surgery, discomfort of skin will occur near the surgical incision. Under normal circumstances, redness and swelling of skin may occur and a little tissue fluid may spill.

Following one to two weeks after surgery, the suture will be removed with the incision healing well. Your doctor will check

without your doctor’s permission;

Keep your incision dry;

Wash hands frequently;

Be sure pillows, sheets, and bedding are clean and keep away pets.

If your pain gets worse, please contact your doctor immediately.

2.2 Avoid infection of incision

During the healing of surgical incision, itch of skin may occur. Other precautions that you can take to prevent an infection include:

Never scratch, touch, or put any pressure on the incision;

Never push the skin near the incision;

Never massage the skin of your head;

Never use lotion or ointment near the incision except the medication prescribed by your doctor;

Never clean the skin near the incision or have a shower

and evaluate whether you have complications. You can leave the hospital and return home if being in good recovery condition.

Following two to six weeks after surgery,the site where the neurostimulator implanted may have sense of pain which will disappear gradually.

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2.3 Signs of infection

2.4 Medication

Medication before, during and after surgery should be taken under the supervision of your doctor. Be cautious if you take other medication not prescribed by your doctor.

If you have following signs, you may have infection of incision and should contact your physician immediately:

Crack at the incision;

Peculiar smell at the incision;

Blood, or oozing at the incision;

A fever of 38 degrees Celsius or higher;

Redness, swelling, or warmth at the incision.

without your doctor’s permission;

Keep your incision dry;

Wash hands frequently;

Be sure pillows, sheets, and bedding are clean and keep away pets.

During the healing of surgical incision, itch of skin may occur. Other precautions that you can take to prevent an infection include:

Never scratch, touch, or put any pressure on the incision;

Never push the skin near the incision;

Never massage the skin of your head;

Never use lotion or ointment near the incision except the medication prescribed by your doctor;

Never clean the skin near the incision or have a shower

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2.5 Other matters needing attention

At the recovery period after surgery, you should avoid:

Strenuous exercise;

Arm upward over your head;

Suddenly or strenuously stretch or tilt your neck;

Suddenly increase the intensity of exercise.

You should call your doctor if you experience any of the following:

Head injury or falling cause damage to the implanted brain pacemaker;

Continuing sensation of burning or tingling, or shock or movement of the implanted brain pacemaker;

Suddenlly change in mood, especially depression;

Feel dizzy or dazzling;

Numbness of face, arms and foot, especially on one side of the body;

Sudden talking and thinking disability problem;

Visual impairment of one or both eyes;

Sudden severe headache;

Change of personality;

Extreme excitement;

Abnormal behavior and speech.

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At the recovery period after surgery, you should avoid:

Strenuous exercise;

Arm upward over your head;

Suddenly or strenuously stretch or tilt your neck;

Suddenly increase the intensity of exercise.

You should call your doctor if you experience any of the following:

Head injury or falling cause damage to the implanted brain pacemaker;

Continuing sensation of burning or tingling, or shock or movement of the implanted brain pacemaker;

Suddenlly change in mood, especially depression;

Feel dizzy or dazzling;

Numbness of face, arms and foot, especially on one side of the body;

Sudden talking and thinking disability problem;

Visual impairment of one or both eyes;

Sudden severe headache;

Change of personality;

Extreme excitement;

Abnormal behavior and speech.

3.2 Turn on DBS therapy

3. Efficacy and Improvement of PINS DBS

3.1 Efficacy of PINS DBS

Patients' responses to electrical stimulation are different. DBS therapy may alleviate some symptoms quickly and improve some symptoms gradually. When the neurostimulator is turned on, most patients may feel alleviated symptoms in a short time, while some patients need treatment for several months.DBS therapy improves symptoms of some diseases by regulating abnormal brain neuronal activities through electrical stimulation and fails curing disease or delaying the progression of disease. You should return to hospital to adjust the optimal parameters as the symptoms will change with the development of diseases.

Under the condition of good recovery after surgery, physicians responsible for programing will turn on your implanted neurostimulator and set stimulus parameters. We call this process as "first startup".

The physician determine the data of first startup according to the following factors:

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Surgery planBased on your selected therapy regimen and physical condition, implantation surgery will be divided in several times, which will delay the data of first startup.

Micro-damage effectClinical symptoms of some patients improve after surgery while restore to preoperative status after several days, which is called micro-damage effect. In order to ensure the accuracy and effectiveness of stimulus parameters, the physician-in-charge will monitor your clinical symptoms and start up at the first time when the micro-damage effect disappears.

Health conditionThe physician-in-charge will evaluate your health condition and need comprehensively to determine the data of startup.

In order to evaluate the efficacy of stimulus parameters of each group and eliminate the interference of medication to optimal stimulus parameters, the physician responsible for programing will ask you to stop partly or all medication before 12-24 hour for first startup. For serious patients who can't stop medication, the physician will reduce the dosage based on patients' actual condition.

Some PD patients may have dyskinesia or dystonia for the regulation of stimulus parameters after first startup. Please

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You can ask your physician to record the treatment parameters on your "program control record" so that you can look up it easily.

3.3 Matters needing attention in programing

When you receive programing at hospital, please bring a recent medication taking record with details of dosage (if taking medication). This record will help your physician to adjust your stimulus parameters and prescription of medicine.

Please cooperate with your physician to diagnose main symptoms.

Please choose optimal stimulus parameters according to the alleviation of main symptoms.

With the improvement of main symptoms, you will find the slight symptoms that are neglected before become more severe.

consult your physician whether you need further observation.

Due to the difference of patients' disease progression and medication taking, after the stimulation start up, programing will be adjusted for several times for optimal efficacy.

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3.4 Regular follow-up

During the process of stimulus parameters adjustment, clinical symptoms may be improved or disappear with the occurrence of side effects. Your physician will adjust your stimulus parameters for an optimal efficacy based on your clinical symptoms.

Please return to hospital for follow-up per six months or one year based on your health condition.

Following the development of disease and tolerance of electrical stimulation, you should visit your physician regularly to adjust stimulus parameters (amplitude, pulse width, frequency, stimulus contact and stimulus mode) for a optimal efficacy. Any changes in your medication regimen should be reviewed with your doctor.

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3.5 Side effects

Some of patients may have side effects during of DBS therapy. Most of side effects caused by electrical stimulationcan be minimized by programming. Side effects caused by medication can be minimized by adjusting stimulus parameters and dosage of medication. Please contact your physician if you have any following symptoms:

Tingling in the head, neck and chest;

Transientdeterioration of the disease;

Slurred speech;

Vision problems (double vision);

Dizziness;

Face and limb weakness or local numbness;

Abnormal or involuntary movement (chorea, dystonia or dyskinesia);

Balance difficulties;

Shock-like sensations;

Limb numbness.

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4.2 Medical contraindications

4.1 Routine medical examinations

4. PINS DBS and Medical Examinations

Routine medical examinations, such as X-ray imaging and ultrasound imaging, have no effects on the normal operation of PINS brain pacemaker.

Ultrasound examinations for diagnosis may not affect your implanted neurostimulator.Ultrasound treatment with high output energy is not recommended. If you need this kind of examination, please get the permission of your doctor.

Electrocardiogram (ECG) and electroencephalogram (EEG) monitoring have no effects on the normal operation of DBS system. However, implanted DBS system may affect the recording waveform of EEG and ECG. Please turn off your neurostimulator before having examinations.

Before you receive any examination or treatment, please tell your doctors your implanted DBS system.

Please pay attention to those following medical contraindications. If you refuse to follow the recommendations, you should take responsibility for the consequences.

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Ultrasound treatmentUltrasound treatment with high energy is not recommended, such as extracorporeal lithotripsy. Ultrasound treatment may damage the neurostimulator. If ultrasound treatment is needed, please tell your doctor the position of implanted neurostimulator and to avoid focusing near the site of neurostimulator.

DiathermyYou can’t have diathermy, such as short-wave diathermy, microwave diathermy and ultrasound diathermy. The energy of diathermy devices can be transmitted to electrodes and cause severe tissue damage, even threatening patients’ life. Whether the stimulation turns on or off, diathermy may damage the implanted brain pacemaker and you must to replace it. Diathermy shouldn’t be used for patients with DBS system.

You shouldn’t have diathermy if you have implanted any parts of implantations (lead, extension or neurostimulator).

Magneticresonance imaging (MRI) scanMRI examination may cause the movement, heating and even damage of the implanted brain pacemaker. Induced current from neurostimulator and electrodes may cause discomfort (shock-like sensations). Meanwhile, the images around the electrodes may twist or show shadow.

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5.2 Complications

5. Daily Life Guide to PINS DBS

Each patient implanted PINS DBS system will have an ID card. This ID card records relevant information about DBS system. Bring your ID card with yourself at all times and show it to your doctors at emergency.Show your neurostimulator ID card or form to ask for assistance in security-checking.

5.1 Introduction to patient’s identification card (ID card)

In daily life, you may have following complications:

Pain at the implanted site of brain pacemaker;

Skin erosion caused by infection or scar;

The lead, the extension or the connecting wire is fractured or disconnected, or moved. A repeat surgery may be needed to adjust placement or replace devices.

Excessive stimulation caused by improper stimulus parameters may lead to cerebral tissue injury.

If you have any above complication, please contact your doctor immediately.

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5.3 Matters needing attention

Please have follow-up regularly and attend the appointment on time.

Tell your dental and health-care providers that you have an implanted neurostimulation system, show them your ID card and point out the site of neurostimulator.

At least one family or nursing staff should know how to operate the controller. If you implanted rechargeable neurostimulator, at least one family or nursing staff should know how to charge.

Please avoid push the implanted brain pacemaker system. Suddenly or repeatedly lowing the head, twisting the neck, jumping or stretching may make the brain pacemaker system displacement or damage which will cause the decrease, suspension and discontinuity of stimulation or stimulious sensation at the damaged part. A repeat surgery may be needed to adjust placement or replace devices.

Please avoid touching or pushing the implanted DBS system (neurostimulator, lead, extension and bone hole cover) and prevent the damage of the brain pacemaker or skin erosion.

Please check the battery status regularly and avoid sudden turn-off because of exhausted battery.

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5.4 EMI

Please contact your doctor in time if any clinical symptoms change.

In daily life, please keep away from equipment that may produce strong electromagnetic field. Strong electromagnetic interference (EMI) may turn on/off the stimulator suddenly.

Some equipment in your home, work place, hospital, super market or other public places (electrical equipment, strong magnetic, equipment electromagnetic equipment) can generate strong electromagnetic field that could prevent the neurostimulator from functioning properly (called EMI). PINS brain pacemaker can prevent EMI to some extent. Common electrical equipment or electromagnetic field may not affect the function of brain pacemaker.

But, strong electromagnetic field may cause following problems:

Severe body damage or death—implanted brain pacemaker generates heat and causes surrounding tissue injury;

Damage of neurostimulator—fail to control clinical symptoms and a surgery is needed to replace neurostimulator;

Change of stimulus parameters—sudden turn-on/off of stimulator, and the neurostimulator even resets itself to factory settings. In this case, you can’t turn on the stimulator and change stimulus parameters. You need contact your doctor to reactivate the neurostimulator.

Shock-like sensations—suddenly increased electric pulse may cause shock-like sensations which only cause discomfort but not tissue injury. In a few cases, patients may fall down due to shock-like sensations to cause injury.

Magnetic bank card is safe for you.

If taking proper prevention measures, the following EMI is safety:

Freezer, refrigerator and magnetic wind-proof door--never lean against those objects, otherwise, your stimulator may be turned off;

Radio frequency interference--mobile phone or cordless telephone may interfere with the output of pulse. Never use those objects near your neurostimulator (at adistance of 10 cm);

Loudspeakers--stereo-speaker, AM/FM radio and or telephone handset has permanent magnetic field, please make the neurostimulator keep away from those devices;

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Some equipment in your home, work place, hospital, super market or other public places (electrical equipment, strong magnetic, equipment electromagnetic equipment) can generate strong electromagnetic field that could prevent the neurostimulator from functioning properly (called EMI). PINS brain pacemaker can prevent EMI to some extent. Common electrical equipment or electromagnetic field may not affect the function of brain pacemaker.

But, strong electromagnetic field may cause following problems:




Shock-like sensations—suddenly increased electric pulse may cause shock-like sensations which only cause discomfort but not tissue injury. In a few cases, patients may fall down due to shock-like sensations to cause injury.

Magnetic bank card is safe for you.

If taking proper prevention measures, the following EMI is safety:




High-voltage power (Outside protection zone is safety);

Radio and television transmission tower (Outside protection zone is safety);

Microwave communication relay station (Outside protection zone is safety);

Linear power amplifier;

High-power supply;

High power amateur radio transmitter;

Electrophoresis equipment;

Magnet and other equipment that can generate strong electromagnetic field;

Degaussing apparatus;

Transcranial magnetic stimulation (TMS) apparatus;

Electric massage chair.

Theft detectors in public library, malls and super markets and security checkpoints in airport, railway station may cause temporary discomfort to some patients, even turning on/off the stimulator suddenly or damaging the neurostimulator.

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Electric sewer or hair drier--household electrical appliances with motor should be kept a distance from neurostimulator;

Disk driver of computer--make your neurostimulator away from disk driver when repairing computer or adding new components;

Electromagnetic oven--keep yourself a distance away from the electromagnetic oven;

Power tool--make the neurostimulator, the lead and the extension be kept a distance away from power tools;

Tablet computer--electronic product with magnetic shell, such as ipad, should be kept a distance away from the neurostimulator.

In daily life, please keep yourself away from those equipments or environment:

Radio antenna;

Welding equipment;

Thermal resistance welding equipment;

Glue gun;

Electric steelmaking furnace;





High-power supply;








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Electromagnetic oven--keep yourself a distance away from the electromagnetic oven;

Power tool--make the neurostimulator, the lead and the extension be kept a distance away from power tools;

Tablet computer--electronic product with magnetic shell, such as ipad, should be kept a distance away from the neurostimulator.


Radio antenna;

Welding equipment;


Glue gun;


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Keep yourself away from environment with EMI when you have discomfort.

Please show your neurostimulator ID card or form and ask for assistance in security checking.

If needed, pass those equipments slowly and avoid staying or leaning against them.

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6.1 Battery life expectancy

6.Battery Replacement and Wireless Charging of PINS DBS

The brain pacemaker works normally depending on the battery in stimulator.The battery life varies depending on the settings needed to control your symptoms. Your physician will set the stimulation mode and parameters based on symptoms alleviation, side effects and energy conservation. The average battery life expectancy of rechargeable neurostimulator is 10 years.

If you see the battery replacement alarm (near depleted) on the screen of controller when you check the battery status of non-rechargeable neurostimulator, contact your doctors and tell them the model of your brain pacemaker to, and ask them arrange the time to replace battery. If you receive the alarm of depleted battery, please contact your doctors immediately to replace battery. When you check the battery status of rechargeable

If you have C701 controller or R801charger, please check the battery status regularly. If you don’t have them, please consult your doctor.

neurostimulator, if you see low battery level or depletion alarm on the screen of controller or charger, charge your battery immediately. If the battery remains in a discharged state, it will become over discharged and cause damage to battery. Over discharging too long may make the battery failed to be charged only to replace battery.

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If you see the battery replacement alarm (near depleted) on the screen of controller when you check the battery status of non-rechargeable neurostimulator, contact your doctors and tell them the model of your brain pacemaker to, and ask them arrange the time to replace battery. If you receive the alarm of depleted battery, please contact your doctors immediately to replace battery. When you check the battery status of rechargeable

6.3 Advice for rechargeable neurostimulator

6.2 Replacement of neurostimulator

Surgery for the replacement of neurostimulator only need to replace the neurostimulator but the lead and the extension. The replacement of neurostimulator refers to the replacement of brain pacemaker battery.

The frequency and time for rechargeable neurostimulator is depend on the parameters setting. If the parameters set high, the cycle of charging will be short and the time will be long.

The time of charging and the remaining battery level of neurostimulator is related with the charging efficacy. The more the remaining battery level is and the higher the efficacy is, the

Stop using when the R801 charger plugs in the adapter for charging.

neurostimulator, if you see low battery level or depletion alarm on the screen of controller or charger, charge your battery immediately. If the battery remains in a discharged state, it will become over discharged and cause damage to battery. Over discharging too long may make the battery failed to be charged only to replace battery.

shorter the time of charging take. In addition, the charger has the function of thermal protection. Too high temperature will stop charging until the temperature become low.

Check the battery status of neurostimulator regularly, if you see depletion alarm (charger shows ), charge your battery immediately. If the battery depletes and you don’t charge it in time, the stimulator will be turned off. If the battery remains in a discharged state for a long time, it will become overdischarged and cause damage to battery. Overdischarge too long may make the battery failed to be charged only to replace battery. Patients should take responsibility for the damage of battery caused by overdischarge.

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The frequency and time for rechargeable neurostimulator is depend on the parameters setting. If the parameters set high, the cycle of charging will be short and the time will be long.

The time of charging and the remaining battery level of neurostimulator is related with the charging efficacy. The more the remaining battery level is and the higher the efficacy is, the

shorter the time of charging take. In addition, the charger has the function of thermal protection. Too high temperature will stop charging until the temperature become low.

Check the battery status of neurostimulator regularly, if you see depletion alarm (charger shows ), charge your battery immediately. If the battery depletes and you don’t charge it in time, the stimulator will be turned off. If the battery remains in a discharged state for a long time, it will become overdischarged and cause damage to battery. Overdischarge too long may make the battery failed to be charged only to replace battery. Patients should take responsibility for the damage of battery caused by overdischarge.

9.2 影响脑起搏器电池电

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7. Brain Pacemaker and Patient Controller

Patient controller is a device to check and manage your brain pacemaker. Before you use it, please read the instruction carefully with your family.

Patient controller is mainly used to check the status of neurostimulator, and allows the patients to adjust within parameters provided by the DBS programmer. Before you pause deep brain the stimulation, use controller to turn off the neurostimulator. Turn the stimulator back on until the process is finished.

Bring your patient controller when you travel.

Do not frequently use patient controller to check whether the brain pacemaker is needed to replace which will decrease the life expectancy of brain pacemaker.

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8. Troubleshooting

DBS therapy may have some complications, including displacement of electrode, system disconnection or short circuit and depletion of battery.

Please pay attention to those changes:

Treatment effect disappears suddenly or discontinuously;

Not common side effects, such as double vision and hallucination;

Shock-like sensations surrounding the head, under the scalp, behind the ear and the lead of the neck;

Tingling sensation, periodic shock or burning sensations near the neurostimulator (called pocket stimulation).

Please use patient controller to check whether the stimulator be turned on and the stimulus parameters be changed.

If you have above symptoms with the stimulator turn-on and parameters not changed, please contact your doctor.

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9.2 Which factors will affect the battery level of brain pacemaker?

9.1 What is the maximum value of brain pacemaker parameters?

9. Frequently Consulting Questions about PINS DBS

We list the frequently consulting questions about PINS DBS as following. If you have other confusion, please contact your doctor.

For your health condition and the normal function of PINS DBS system, please pay attention to the following contents and use this system according to the following suggestions and your doctor’s advice. You should take responsibility for the consequence if you don’t comply with the advice.

The parameters range is different for the difference of product type. Please consult your doctor for details.

You can check the battery statue by using C701 patient controller

For the need of safety, the range of parameters used in clinic is less than the actual range of neurostimulator.

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9.3 Why are electromagnetic fields a problem?

PINS brain pacemaker can prevent EMI to some extent. Common electrical equipmentor electromagnetic field may not affect the function of brain pacemaker. But, strong electromagnetic field may cause following problems:


and R801 charger. Factors may affect the battery level of brain pacemaker includes:

The time of turning on the stimulator;

The number of electrode contact used;

Monopolar or bipolar stimulation mode;

The size of treatment resistance;

The selection of stimulation target;

The times of programming;

The times of telemetering;

The times of charging.

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9.4 Can I use everyday household appliances?

Most electrical appliances will not affect your DBS system. If patients doubt the neurostimulator is interfered by the electro- magnetism of some electrical appliances, please conduct to check according to the following process:

Keep away from the electrical appliance;

If possible, ask others turn off the electrical appliance;

If needed, turn on/off stimulator by using patient controller;



Shock-like sensations—suddenly increased electric pulse may cause shock-like sensations which only cause discomfort but not tissue injury. In a few cases, patients may fall down due to shock-like sensations and cause injury.

Tell your symptoms to the host or operator of this electrical appliance.

If the above can’t eliminate the existence of EMI, or patients doubt that EMI interrupt the treatment, please contact your DBS physician.

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Most electrical appliances will not affect your DBS system. If patients doubt the neurostimulator is interfered by the electro- magnetism of some electrical appliances, please conduct to check according to the following process:

Keep away from the electrical appliance;

If possible, ask others turn off the electrical appliance;

If needed, turn on/off stimulator by using patient controller;

9.5 Which equipment may have EMI? How can I prevent EMI?

If proper prevention measures taken, the following EMI is safety:





Tell your symptoms to the host or operator of this electrical appliance.

If the above can’t eliminate the existence of EMI, or patients doubt that EMI interrupt the treatment, please contact your DBS physician.

9.13 我可以接受放射线

9.14 我可以进行高能超

9.15 我可以使用激光治

9.16 我可以接受普通外

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9.6 Which equipment or environment I should keep away from?


Radio antenna;

Welding equipment;


Glue gun;




Electromagnetic oven--keep a distance from the electromagnetic oven;

Power tool--make the neurostimulator, the lead and the extension kept a distance away from power tools;

Tablet computer--electronic product with magnetic shell, such as ipad, should be kept a distance from the neurostimulator.

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High-power supply;








Always show your neurostimulator ID card or form and ask for assistance in security checking.

If needed, pass those equipment slowly and avoid staying or leaning against them.

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9.9 Can I have X-ray imaging examination?

9.7 Can I have a perm or dye hair?

9.8 Can I have MRI examination?

Perming or dying hair is not recommended. The high temperature during the process of perming will cause the breakdown of pacemaker. The dye will penetrate into the scalp through hair follicle and cause electrode infection.

MRI examination may cause the displacement, heaing and even damage of the implanted brain pacemaker. Induced current from neurostimulator and electrodes may cause discomfort (shock-like sensations). Meanwhile, the images around the electrodes may twist or show shadow.

Yes. X-ray imaging will not affect brain pacemaker. Only when breast radiography or X-ray imaging with tightness is performed, the overpressure may damage neurostimulator and cause disconnection between components. A surgery is needed to repair or replace the components. Please ask the medical staff to adjust the X-ray imaging equipment and limit the pressure.

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9.13 Can I have radiation therapy?

9.12 Can I have dental check-up and use dental bur?

9.11 Can I have routine imaging examination?

9.10 Can I have diagnostic ultrasound (carotid Doppler)?

Diagnostic ultrasound (carotid Doppler) will not interfere brain pacemaker. Please turn off the stimulator and make detector 15cm distant from the DBS system.

Yes. Please turn off the stimulator and make sure the detector kept 15cm distant from the DBS system.

Yes. Please tell the medical staffs not to make Cobalt 60 or Gamma ray directly on brain pacemaker. If the treatment site is near the brain pacemaker, place a leadshield on the implanted site. After the radiation therapy, check the statue of neurostimulator.

CT, CAT, MEG and PET will not interfere brain pacemaker. Please turn off the stimulator.

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9.16 Can I have general surgery?

9.15 Can I have laser therapy?

9.14 Can I have high intensity ultrasound or lithotripsy?

High intensity ultrasound or lithotripsy is not recommended. If needed, please tell the medical staffs not to focus on the energy beam within 15cm distant from the neurostimulator. If not prevented well, the neurostimulator may be damaged only to replace.

Yes. Please turn off the stimulator and tell the medical staffs do not aim the laser at the brain pacemaker.

Yes. Please tell the medical staffs that you have an implanted neurostimulation system and show them your ID card.

Please consult your physician-in-charge that, whether electrocoagulation could be used during the surgery. If used, tell the medical staffs to use electrocoagulation based on the following procedures:

Turn off the stimulator before using electrocoagulation;

Only bipolar coagulation is recommended;

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9.17 Can I implant other medical devices?

If you need implant other medical devices (such as heart pacemaker, implantable cardioverter defibrillator and electrical cochlea), care must be taken with their placement and programming so as not to interfere with the DBS system. Please tell your physician-in-charge to pay attention to the following principles:

Neurostimulator and other implanted devices should not be placed in one side;

Neurostimulator should use bipolar stimulation mode;

Check the implanted devices and make sure them work independently;

Never use patient controller to control other devices (such as heart pacemaker).

Never use high voltage mode;

Set the minimum value of energy;

Make the ground plane away from the neurostimulator, the lead and the extension;

Shorten the time of operation;

Check the neurostimulator after electrocoagulation.

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9.19 Can I have electrical stimulation (or magnetic stimulation) to treat mental diseases?

9.18 Can I use external defibrillation if I have atrial fibrillation or ventricular fibrillation?

When patients have atrial fibrillation or ventricular fibrillation, consider the life firstly. External defibrillation may damage neurostimulator. The emergency workers should make the electrode plate away from neurostimulatoras far as possible. If external defibrillation or electrical conversion is needed, please comply with the following procedures:

Make the electrode plate away from neurostimulatoras far as possible;

Make the connection of electrode plates and the component of brain pacemaker vertical;

Use the minimal energy output mode (watt/sec);

Check the functions of PINS devices after defibrillation.

For patients receiving DBS therapy, the safety of electromagnetic equipment (such as electrical shock and TMS) used to treat mental diseases is not determined.

9.23 Can I take flight a long duration?

9.22 Can I use transcuataneous electrical nerve stimulation (TENS)?

9.21 Can I use bone growth stimulators?

9.20 Can I have radiofrequency ablation or microwave ablation?

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Never place the electrode of stimulator on any site that can transmit the current to brain pacemaker. If patients feel that the TENS may interfere with the implanted system, please consult your doctor.

For patients receiving DBS therapy, the safety of radiofrequency ablation or microwave ablation is not determined.

For patients receiving DBS therapy, the safety of bone growth stimulators is not determined.

Yes. Your implanted DBS system will not be affected by long duration flight.

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9.27 Can I use sunbeds?

9.26 Can I have hot shower, spa or sauna?

9.25 Can I drive an automobile?

9.24 Will other security systems interfere with my DBS system?

Avoid the theft detectors and security checkpoints in public library, super markets and airport as far as possible. Please show your neurostimulator ID card or form and ask for assistance in security checking. If needed, pass those equipments slowly and avoid staying or leaning against them.

The decision about driving is a complex one. Talk with your health-care team and your family.

Hot shower, spa or sauna is not recommended, because those activities may expose the brain pacemaker to higher than normal levels of heat.

Sunbed is not recommended, because the sunbed may expose the brain pacemaker to higher than normal levels of heat.

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9.30 Can I dive or use hyperbaric oxygen chamber?

9.29 What should I pay attention to before travel?

9.28 What kind of exercise I should avoid?

Please avoid pushing the implanted brain pacemaker system. Suddenly or repeatedly lowering the head, twisting the neck, jumping or stretching may make the brain pacemaker system displacement or damage which will cause the decrease, suspension and discontinuity of stimulation or stimulation sensation at the damaged part. A repeat surgery may be needed to adjust placement or replace devices.

Please avoid touching or pushing the implanted DBS system (neurostimulator, lead, extension and bone hole cover) and prevent the damage of the brain pacemaker or skin erosion.

Bring your ID card and patient controller at any time. If you implanted rechargeable neurostimulator, please bring your charger.

The depth of diving should less than 10 meters. The pressure of hyperbaric oxygen chamber should less than 2.0 atmosphere

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9.33 Can I be near electric substations or power lines?

9.32 Can I ski or hike?

9.31 Can I skydive?

Skydiving is not recommended. While high altitudes should not affect the neurostimulator, skydiving involves movement and impact that could easily damage your DBS system.

Skiing or hiking may have potential risk of brain pacemaker damage caused by falling down, suddenly twisting or stretching. Please consult your physician-in-charge before skiing or hiking.

Yes. Just stay outside of the protective fence around these installations.

absolute (ATA) or 29.4 pound/square feet (psia). If beyond this range, the neurostimulator may be damaged. Please consult your physician-in-charge before diving or using hyperbaric oxygen chamber.

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9.34 Can I weld?

No! welding has potential risks to patients with DBS system.

9.35 Can I work on an automobile?

Yes, but you may experience discomfort if you engage in excessive bending or twisting, which may dislodge or fracture your neurostimulator. Avoid leaning directly on your battery implants.

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10. Glossary of Terms

AmplitudeThe strength or intensity of an electrical pulse (V, mA). Amplitude is one of the parameters of brain pacemaker.

LevodopaA kind of medication for the treatment of PD. Madopar and Sinomet is commonly used.

Pulse widthThe length or duration of an electrical pulse (uS). Pulse width is one of the parameters of brain pacemaker.

FrequencyThe time of electrical pulse per sec (Hz).Frequency is one of the parameters of brain pacemaker.

BatteryA important component of neurostimulator and provide energy for brain pacemaker.

Physician programmerA computer used to program the DBS system. Your health-care team can change the therapy settings using this programmer.

Electromagnetic interference (EMI)Electrical or magnetic energy that is strong enough to interfere with or disrupt medical therapy.

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ContraindicationsIndicates that a procedure, device or drug should always be avoided because of the health risks.

Parkinson disease (PD)PD is a long-term degenerative disorder of the central nervous system that mainly affects the motor system. Four motor symptoms are considered cardinal in PD: tremor, rigidity, slowness of movement, and postural instability.

Electrical stimulationLow energy electrical pulses that transmit to brain and prevent the conduction of incorrect information.

Temporary stimulusTo evaluate and determine the symptoms controlling methods during the process of electrode implantation.

ProgrammingProgrammer places the programming device on the skin above the neurostimulator to send stimulation order to neurostimulator so as to control the electric pulse signal.

Stimulation turn-onturn on

Stimulation turn-offturn off

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5:00AM

Name Date

11. Parkinson Disease Diary

6:00AM

2:00PM

10:00AM

6:00PM

1:00AM

7:00AM

3:00PM

10:00PM

11:00AM

7:00PM

2:00AM

8:00AM

4:00PM

11:00PM

12:00PM

8:00PM

3:00AM

9:00AM

5:00PM

12:00AM

1:00PM

9:00PM

4:00AM

time point

start time

finish time

medication taking time,

name and dosage

dyskinesia with

influence

dyskinesia without influence

sleep

Notes: the time of taking medicine, starting and finishing should be right to the minute.

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Medication treatmentName of medicine: Dosage:

Name of medicine:

Start time (h/d)

Finish time (h/d)

Dosage:

Name of medicine: Dosage:

Name of medicine: Dosage:

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Charging coil

Communication coil Patient controller Rain cover and strap

External charger, holster

12. Multifunctional Bag

B E

CDA

12.1 Diagram of bag

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Remove the strap and use rain cover to cover the bag and connect ① and ②

take ② through ①, repeat it on the other side

connect the strap and ②

12.2 Diagram of rain cover

√

12

1

2

beijing pins medical co., ltd. patient manual manual.pdf · for deep brain stimulation beijing pins...

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