User Manual. Patient Programmer Recharger for Deep Brain Stimulation. Beijing PINS Medical Co., Ltd. MODEL R801. Beijing PINS Medical Co., Ltd.

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1 Beijing PINS Medical Co., Ltd. 1st Floor and 5th Floor Building 1,No.1,Xingchang Road Changping Science Park Beijing P. R. China Patient Programmer Recharger for Deep Brain Stimulation User Manual MODEL R Beijing PINS Medical Co., Ltd.

2 A Disclaimer Welcome to use PINSTM products manufactured by Beijing PINS Medical Co., Ltd. Prior to implanting and using the PINSTM deep brain stimulation (DBS) system, read and understand all instructions in the implantable pulse generator, controller, programmer, test stimulator, test extension kit, lead and extension kit instructions for use. Failure to properly follow the instructions, warnings, and precautions may lead to adverse complications with this device. In no event will Beijing PINS Medical Co., Ltd. (PINS Medical) be liable to you for any incidental or consequential damages resulting from your mishandling or misuse of this product. PINS Medical is dedicated to continuous improvement of our services and product performance. We reserve the rights to change or modify the contents of instructions for use for all products without prior notice. This Instruction for use is copyright protected by PINS Medical. PINSTM is the trademark of Beijing PINS Medical Co., Ltd. Other trademarks that may appear in this Instruction for use are the property of their respective owners. Please contact PINS Medical for the most up-to-date information, your suggestions and comments.

3 Beijing PINS Medical Co., Ltd. 1st Floor and 5th Floor Building 1,No.1,Xingchang Road Changping Science Park Beijing P. R. China EC REP Clifton MedTech Consulting Ltd. 4 Royal York Crescent Bristol, BS8 4JZ United Kingdom Telephone: Year of Authorization: 2016 Release Record Jan 2015 Version 1.0 Sep 2016 Version 2.0 Feb 2017 Version 3.0 Beijing PINS Medical Co., Ltd All rights reserved.

4 Description of Symbols Caution, Consult Accompanying Documents Manufacturer Serial Number Lot Number Type BF applied parts Table of Contents 1 General Information Device Description Radio Frequency Characteristics Power Supply Package Contents Sterilization Conditions for Storage and Transport 05 2 Indication for Use 06 Consult Instructions for Use 3 Contraindications, Potential Adverse Effects, Warnings 07 Date of Manufacture 4 Components 08 Temperature Limitations Humidity Limitations Atmospheric Pressure Limitations Authorized Representative in the European Community 4.1 The Charge Controller The Charge Coil The Power Adapter 10 5 LCD Display Symbol Descriptions 11 6 Instruction for Use Installation Align the Charge Coil Turn on the Charge Controller 16

5 6.4 Turn on/off IPG Stimulus Output Start Communication/Charging the IPG Re-adjust the Coil Position Charging Completed Turn off the Charge Controller Charge the Charge Controller Delayed Backlight and Key Lock Automatic Shutdown Turn on/off Buzzer Cancel Communication Pause the IPG Charging 24 7 Charging Cycle and Duration 26 8 Troubleshooting Service Declaration of Conformity 39 Appendix 1 Electromagnetic Emission and Immunity Failure Message: Communication Error Failure Message: Charging Error Failure Message: The IPG Battery is Low Failure Message: The Charge Controller Battery is Low Failure Message: The IPG Temperature too High Burning Sensation at IPG Implant Site 33 List of Tables 8.7 Failure Message: The Charge Coil Temperature too High 34 Table 4.1 The charge controller buttons Wrong Power Adapter 36 Table 5.1 LCD display symbol descriptions 11 Table 5.2 Symbols in the main menu 12 9 Maintenance 37

6 List of Figures Figure 1.1 The patient programmer recharger model R Figure 4.1 The charge controller 08 Figure 4.2 The charge coil 10 Figure 4.3 Power adapter 10 Figure 5.1 The charge controller display 11 Figure 6.1 Charging the charge controller 13 Figure 6.2 Charging the IPG battery 13 Figure 6.3 Align the charge coil 16 Figure 6.4 Charge controller boot screen 17 Figure 6.5 [Initializing] interface 17 Figure 6.6 <IPG current battery status> bar is rolling when charging 18 Figure 6.7 <IPG charging efficiency indicator> bar appears when charging 19 Figure 6.8 [Charging completed] interface 20 Figure 6.9 [Shutting down] interface 21 Figure 6.10 Pause the IPG charging 25 Figure 8.1 Failure message: communication failure 28 Figure 8.2 Failure message: charging error 29 Figure 8.3 The coil centre aligns with the IPG centre 29 Figure 8.4 Failure message: IPG battery low 30 Figure 8.5 Failure message: low battery in the charge controller 32 Figure 8.6 Failure message: the IPG temperature is too high 33 Figure 8.7 Failure message: the charge coil temperature is too high 35 1 General Information This manual contains information about the PINSTM patient programmer recharger for deep brain stimulation (referred thereafter as the recharger) Model R801 manufactured by PINS Medical. 1.1 Device Description The patient programmer recharger model R801 is one of the external devices of the PINSTM deep brain stimulation system. It is used to charge the implantable pulse generator (IPG) model G102R. The model G102R is a dual channel rechargeable implantable pulse generator. The model R801 consists of three components: a charge controller, a charge coil and a power adapter. The charge controller and the charge coil are permanently connected, while the power adapter can be unplugged from the charge controller

7 Buzzer Monitor and warn the battery status in the IPG and in the controller BF type applied part Degree of protection from ingress of liquids: IP Radio Frequency Characteristics Figure 1.1 The patient programmer recharger model R801 Features of the Model R801 recharger include: Equipment Name: General micropower (short distance) radio transmission equipment Handheld Equipment Type: R801 Telemetry communication between the charge coil and the IPG Main Function: Data transmission Recharge the IPG battery via inductive link Control of start/stop of the stimulus output of the IPG High temperature protection mechanism Automatic shutdown function Screen backlight Radio transmission equipment type approval certificate (China): CMIIT ID: 2014DP1170 Modulation Mode: FSK PPM Frequency Range: 9-12kHz, khz Transmitting Power 72dBμA/m (field of 10 meters, quasi-peak value ) 69dBμA/m (field of 10 meters, quasi-peak value ) Spurious Emission Limit: 27dBμA/m (10 meters, quasi-peak value) 03 44

8 1.3 Power Supply 1.5 Sterilization The charge controller is powered by a rechargeable battery (GRP C-2500mAh 7.4V, manufactured by GRP ltd, China) The product is not sterilized. A standard power adapter is used for charging the battery in the recharger. (Input: V, 47-63Hz, 0.58A MAX. Output: 9V, 2.5A, 22.5W MAX) 1.4 Package Contents The following items are included in the recharger package: 1- Charge controller 1- Charge coil 1- Power adapter 1- User manual 1.6 Conditions for Storage and Transport The product shall be stored in a cool, dry and well ventilated place, away from strong electromagnetic field and corrosive environment. Storage Temperature: store at room temperature. Excursions permitted during transportation between -20 C to + 55 C Relative Humidity Range: 0 to 80% WARNING Do not expose the package in wet condition and avoid direct sunlight. Avoid excessive vibration when transporting the device. 1- Product qualification certificate The charge controller is permanently connected with the charge coil. The power adapter can be detached from the charge controller

9 2 Indication for Use The PINSTM recharger is for use to recharge the battery in the deep brain stimulation implantable pulse generator model G102R Contraindications, Potential Adverse Effects, Warnings Refer to user manuals of the lead, the extension or the implantable pulse generators for contraindications, potential adverse effects, warnings for PINSTM DBS system

10 4 Components Table 4.1 The charge controller buttons Name 4.1 The Charge Controller Function Power button Turn on/off the charge controller LCD screen Display and monitor Charge button Start the communication and charging Pause button Pause the communication and charging Buzzer Start and stop the buzzer Start/Stop Stimulus Control the start and stop of the stimulus output 4.2 The Charge Coil The charge coil is connected with the charge controller and used for wireless charging and communication via inductive links. Figure 4.1 The charge controller 1. Power button 2. LCD screen 4. Pause button 5. Buzzer Charge button 6. Start/Stop Stimulus 09 44

11 5 LCD Display Symbol Descriptions Status bar Main menu Figure 4.2 The charge coil 4.3 The Power Adapter The power adapter is for use to charge the battery in the charge controller. Figure 5.1 The charge controller display Table 5.1 LCD display symbol descriptions- Number Status The battery status for the charge controller: Battery is full 1 Battery is empty Filling of the battery bar corresponds to the current battery level Figure 4.3 Power adapter Please be noted that the real plug may vary with different standards among countries In battery charging process via power adapter. When in charging the battery bar is rolling, and when the charging completes/stops the battery bar stops rolling and shows the current battery level 11 44

12 -Table 5.1 LCD display symbol descriptions Number Status The buzzer status: 2 Buzzer is on 6 Instruction for Use 6.1 Installation Buzzer is off 3 4 Stimulus output status: Stimulus output is on Stimulus output is off IPG charging efficiency indicator: The bar indicates charging efficiency from minimum to maximum. Table 5.2 Symbols in the main menu Symbol Description Network Mains Figure 6.1 Charging the charge controller IPG current battery status Patient Programmer Recharger The IPG High temperature warning Charge coil The IPG Pause Figure 6.2 Charging the IPG battery 13 44

13 CAUTIONS Read instruction for use thoroughly before using the device. Electromagnetic interference may cause communication error. Do not use the device in the vicinity of electromagnetic fields. The apparatuses which may generate electromagnetic disturbance include magnetic resonance imaging system, computer display unit, mobile phone, power adapter, X-ray apparatus, etc. WARNINGS The recharger may generate electromagnetic interference when charging the IPG, affecting normal operations of the other implantable medical devices, such as implantable pacemakers/defibrillators, cochlear implants, etc. This recharger is used only for charging PINSTM rechargeable IPGs. Contact your clinician if the IPG type is uncertain. Do not use the device near chemical plant, gas station or other potentially explosive objects. Do not use the patient programmer recharger to charge the IPG when the recharger is being connected with the network mains. CAUTION Fully charge the patient programmer recharger via a power adapter before using it to charge an IPG. After use, the patient programmer recharger should be fully charged again before storing CAUTIONS Place the patient programmer recharger and the power adapter in a place easy to reach in case of an emergency situation. When in use, the charge controller should be kept apart from the charge coil for at least 50 mm. Ensure adequate ventilation when charging the IPG. Do not place objects between the charge coil and the skin on IPG implant site. The objects may prevent dissipation of the heat. 6.2 Align the Charge Coil CAUTIONS Do not place objects which could adversely affect dissipation of heat around the charging coil. The charge coil can contact the skin directly. Patient can also wear thin layers of cotton clothes under the coil for comfort. Never wear clothes with any filling metal or decorated with metal when charging the IPG. Never place metal, metal-containing products, or objects containing magnetic conductors near the charge coil (say less than 50 mm), or between the charge coil and skin when charging the IPG. Take off metal jewellery before using the device

14 1. Locate the implanted IPG. 2. Place the charge coil over the IPG. Let the side bearing PINS logo face outwards. Make sure the center of the coil is aligned with the center of the IPG (Figure 6.3). PINS Figure 6.4 Charge controller boot screen 2. Following the boot screen, the controller buzzes once (make sure to turn the buzzer on) and the [Initializing] interface appears ( Figure 6.5). Figure 6.3 Align the charge coil Figure 6.5 [Initializing] interface 6.3 Turn on the Charge Controller 6.4 Turn on/off IPG Stimulus Output 1. Shortly press on the power button appear ( Figure 6.4). 1. When the charge controller turns on and enters the [Initializing] interface, user can press the start/stop stimulus button for 10s to turn on/off the IPG stimulus output..the boot screen will The firmware version (xxxxx) is displayed on the right side. If a previous automatic shutdown was caused by a fault, the bottom left corner will display the code for the error If no display on the screen, press the power button briefly and then release. The [Initializing] interface will be displayed on the screen. Then proceed to turn on/off the stimulus output

15 3. The stimulus output symbol on the display changes to the corresponding stimulus output status. The <IPG charging efficiency indicator>bar appears on the top-right corner. Three or more bars indicate that the charge coil is correctly positioned (Figure 6.7) 6.5 Start Communication/Charging the IPG Press the charge button for once, the controller then starts to communicate with the IPG. Press the charge button once, once the communication is successfully established it enters into the interface of pausing, displaying the current battery capacity of the pulse generator. Then press the charge button again to start the charging process. The <IPG current battery status> bar in the main menu starts rolling (Figure 6.6). Figure 6.7 <IPG charging efficiency indicator> bar appears when charging 6.6 Re-adjust the Coil Position 1. If <IPG charging efficiency indicator> bar shows less than three bars, repositioning of the coil is required. To reposition the coil: 1) Press the pause button the charging. to pause the communication and 2) Adjust the coil position. Figure 6.6 <IPG current battery status>bar is rolling when charging ) Press the charge button to restart the charging

16 4) When <IPG charging efficiency indicator> bar shows equal to or more than three bars,stabilise the coil position and continue the charging until completion. Shutting down 6.7 Charging Completed When the charging is completed, the <IPG current battery status> icon blinks and the battery status bar is fully filled (Figure 6.8). Figure 6.9 [Shutting down] interface. CAUTIONS The recharger can be switched off at any time. If the power button is released too soon, the controller will not be switched off. Instead the display will enter [Initializing] interface as shown in Figure 6.5. If the power button is pressed by mistake, release the button quickly. The display will enter [Initializing] interface to restart the controller. Figure 6.8 [Charging completed] interface CAUTION At the end of charging process, it is normal to observe a slight drop of charging efficacy. 6.8 Turn off the Charge Controller To turn off the controller, press the power button until the progress bar on the [Shutting down] interface finishes Charge the Charge Controller 1. The battery status for the charge controller is displayed on top-left corner. When the battery level is low, the icon blinks. 2. To charge the controller, connect the power adapter with the controller, then plug the adapter into the mains

17 3. When in charging the battery bar is rolling. When the charging completes/stops the battery bar stops rolling and shows the current battery level. 4. After it is fully charged, unplug the power adapter firstly before operating the charge controller. CAUTION When the charging controller is in power-off status, inserting the power adapter will turn on the charging controller automatically and start to charge the controller battery Delayed Backlight and Key Lock 1. The backlight on the display lasts for one minute once it turns on. Pressing on any button will extend the backlighting for one more minute. 2. When the backlight turns off, all controller buttons are locked. This is to prevent mis-operating of the buttons. Pressing on any controller button will turn on the backlight but will not execute the button function. 3. The button functions are enabled again only after the backlight has turned on Automatic Shutdown 1. Except in a stable charging process, the controller will turn off automatically one minute after the screen backlight is off CAUTION When charging the IPG, the charge controller is powered by the battery only. There is no connection to the mains. 2. When the charge controller is being charged via the power adapter, the automatic shutdown function is not in use unless there is a malfunction Turn on/off buzzer Press the buzzer button briefly to turn on/off the sound. There are three different sounds: 1) A short beep sound indicates a normal operation, such as starting communication by pressing the Charge button briefly. 2) A long beep sound indicates the completion of charging or automatic shutdown due to malfunctioning. 3) A short and constant beep sound indicates following issues: Communication error Charge error Temperature excursion of the IPG Low battery voltage of the IPG 23 44

18 Low battery voltage of the charge controller. (when the battery voltage drops below a certain value, the charge controller will shutdown automatically. It will be a long beep while it is shutting down). Temperature excursion of the charge coil, etc. This sound repeats every 30s to draw user attention to take care of the issues. Figure 6.10 Pause the IPG charging 6.13 Cancel Communication Pressing the pause button during the communication process between the patient programmer recharger and IPG will lead to the cancellation of the communication. The screen display returns to [Initializing] interface. The controller will shut down automatically if no further operation is taken within a period of time Pause the IPG Charging 1. Press the pause button during the charging process to suspend the charging. The Pause symbol will appear on the display. 2. To resume the charging, press the charge button The charging efficiency will be updated and displayed. briefly. 3. The controller will automatically shut down after a long period of pausing

19 7 Charging Cycle and Duration The required charging time is determined by several factors: Charging speed setting (grade 1, grade 2, grade 3, and grade 4) CAUTIONS The faster the charging speed, the greater the heat generated. Make sure to use the device in a well-ventilated environment. If ambient temperature is too high, adjust the charging speed to a lower grade so to reduce the amount of heat generated. The patient programmer recharger should be fully charged before storage. Charging interval IPG parameter settings Ambient temperature Clinical trials showed that most patients (about 83%) choose grade 2 for charging. The average charging interval is around 8 days, and average charging time is around 60 minutes. It is recommended to charge the IPG once every week, and to set the grade 2 as the default charging speed by the clinician programmer. Make sure to use the device in a well ventilated environment because the higher charging speed will generate greater amount of heat. CAUTION Ambient temperature will greatly affect the charging process. Using air cooling measures (using air conditioner or electric fan, etc.) is recommended when ambient temperature is too high

20 8 Troubleshooting Users may encounter the following messages when operating the recharger: 8.1 Failure Message: Communication Error If the communication cannot be established, the [communication failure] page will appear: 1) The failure symbol blinks on the display (Figure 8.1). 2) The backlight turns on. CAUTION If there is no operation for a long period, the controller will shut down automatically. 8.2 Failure Message: Charging Error Charging error may due to improper positioning of the charge coil or other causes. When it occurs following signals appear: 1) The display indicates user to adjust the coil position. 2) The backlight turns on. 3) The buzzer beeps. 3) The buzzer beeps. Figure 8.2 Failure message: Charging error Figure 8.1 Failure message: communication failure Trouble shooting: Align the coil to the correct position and press the charge button to re-start communication Figure 8.3 The coil centre aligns with the IPG centre 29 44

21 Troubleshooting: Align the coil to the correct position and press the charge button to re-start charging. CAUTION If there is no operation for a long period, the controller will shut down automatically. 8.3 Failure Message: The IPG Battery is Low When the battery level in the IPG is too low: 1. The battery status symbol blinks. 2. The battery bar is unfilled. 3. The backlight turns on. 4. The buzzer beeps. Troubleshooting: WARNINGS The IPG will stop the stimulus output when the battery level is too low. Low battery voltage of the IPG may lead to the excessive discharge of the battery and cause further damage to the battery. The excessive discharge may affect the lifespan of the battery and its capacity, and may even severely damage the battery. When the IPG low battery is indicated, charge the IPG immediately in order to protect the battery. 8.4 Failure Message: The Charge Controller Battery is Low When the battery level in the charge controller is too low: 1. The battery status symbol blinks. 2. The battery icon on the main menu blinks. 3. The battery bar is unfilled. 4. The backlight turns on. 5. The buzzer beeps. Figure 8.4 Failure message: IPG battery low

22 3. The backlight turns on. 4. The buzzer beeps. Figure 8.5 Failure message: low battery in the charge controller Troubleshooting: CAUTIONS The recharger will stop charging the IPG when the battery level in the charge controller is too low. The charge controller will turn off automatically when battery is depleted unless being connected with the power adaptor to start charging. Charge the charge controller immediately when low battery warning appears. Leave the battery in depleted status for long period will shorten the effective lifespan of the battery or cause permanent damage. Figure 8.6 Failure message: the IPG temperature is too high Troubleshooting: CAUTIONS Ensure to perform the charging process in a cool and well-ventilated place. If the charging stops due to temperature protection by the IPG, wait for the IPG to cool down and then press the Charge button to restart. If the recharging is not started after a period of time, the charge controller will shut down automatically. 8.5 Failure Message: The IPG Temperature too High When the IPG temperature is too high: 1. The charging process stops automatically. 2. IPG icon and high temperature warning icon on the main menu blink Burning Sensation at IPG Implant Site Take following actions if a patient experiences burning sensations at the IPG implant site during charging: 33 44

23 Stop charging and only restart after the patient feels better. 2. The controller icon and high temperature warning icon on the main menu blink. Check the charge coil position to make sure a good charging efficiency. 3. The backlight turns on. 4. The buzzer beeps. Reduce the charging duration each time. Opt for more frequent charging intervals and a lower charging speed. Patients may be prescribed with anaesthesia medicine to ease the burning sensations during charging. Charge the IPG during sleep may reduce sensations caused by charging. Drinking water may reduce sensations caused by charging. Contact your clinician or PINS Medical if the burning sensations persist and the above preventive actions are not effective. 8.7 Failure Message: The Charge Coil Temperature too High When the charge coil temperature is too high: Figure 8.7 Failure message: the charge coil temperature is too high Troubleshooting: CAUTIONS Ensure to perform the charging process in a cool and well-ventilated place. If the charging stops due to temperature protection by the controller, wait for the charge coil to cool down and then press the Charge button to restart. If the recharging is not started after a period of time, the charge controller will shut down automatically. 1. The charging process stops automatically

24 8.8 Wrong Power Adapter Using a power adapter that is not authorised by PINS Medical may damage the charge controller. Once a mismatched power adapter is detected, the charge controller will produce a long beep and then shut down automatically. When power-on the controller again an error code will appear on the lower-left corner on the display. Contact PINS Medical if the error code appears persistently. 9 Maintenance Keep the patient programmer recharger away from dust and water. If it will not be used for a long time, fully charge the controller battery and store in a cool and dry place. Wipe clean the recharger with a dry cloth before reuse. Contact PINS Medical service personnel if there are problems on the recharger. Do not dismantle the recharger. PINS Medical assume no responsibility for the product if they are dismantled by the users. Dispose the out of service recharger according to local regulations or send it back to PINS Medical. Contact PINS Medical service personnel if there is any doubt. CAUTIONS Do not place the recharger in humid and dusty environment. Humidity and dust will affect lifetime of the electronic products. Never spill liquid on the product

25 10 Service For technical issues or questions about the patient programmer recharger,please contact customer service at following address: Beijing PINS Medical Co., Ltd. 1st Floor and 5th Floor Building 1,No.1,Xingchang Road Changping Science Park Beijing P. R. China Declaration of Conformity PINS Medical declares that this product is in compliance with the essential requirements and other relevant provisions of Directive 90/385/EEC on Active Implantable Medical Devices and Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment. Please contact PINS Medical on the above address to obtain a full text of Declaration of Conformity

26 Appendix 1 Electromagnetic Immunity Electromagnetic Emission and Immunity The model R801 patient programmer recharger is intended for use in the electromagnetic environment specified below. The customer or the user of the model R801 patient programmer recharger should assure that it is used in such an environment. Electromagnetic Emissions The model R801 patient programmer recharger is intended for use in the electromagnetic environment specified below. The customer or the user of the model R801 should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 Compliance Electromagnetic environment guidance Group 2 The model R801 patient programmer recharger must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions CISPR 11 Class B Harmonic emissions IEC Class A Voltage fluctuations/ flicker emissions IEC Complies The model R801 patient programmer recharger is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Immunity test IEC test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC ±6 kv contact; ±8 kv air ±6 kv contact; ±8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC ±2 kv for power supply lines; ±1 kv for input/output lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge IEC ±1 kv line(s) to line(s); Not applicable ±2 kv line(s) to earth <5 % UT (>95 % dip in UT) Voltage dips, short for 0.5 cycle 40 % UT interruptions and (60 % dip in UT) voltage variations Not applicable for 5 cycles on power supply 70 % UT input lines (30 % dip in UT) IEC for 25 cycles <5 % UT (>95 % dip in UT) for 5 s Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m The device is connected to the Mains only when charging the battery to the patient programmer recharger. Mains power quality should be that of a typical commercial or hospital environment. The device is connected to the Mains only when charging the battery to the patient programmer recharger. The Model R801 Patient Programmer Recharger is powered from a battery when in operation of charging an implantable pulse generator. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low. NOTE UT is the a.c. mains voltage prior to application of the test level

27 Electromagnetic Immunity The model R801 patient programmer recharger is intended for use in the electromagnetic environment specified below.the customer or the user of the model R801 patient programmer recharger should assure that it is used in such an environment. Immunity test Conducted RF IEC IEC test level 3 Vrms 150 khz to 80 MHz Compliance level 3 Vrms NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Model R801 Patient Programmer Recharger, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model R801 is used exceeds the applicable RF compliance level above, the Model R801 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model R801. b: Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distance d = 1,2 P d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2.5 GHz 3V/m Radiated RF IEC V/m 80 MHz to 2.5 GHz 3V/m where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol: NEXT PAGE

28 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Model R801 Patient Programmer Recharger The model R801 patient programmer recharger is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model R801 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model R801 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 khz to 80 MHz 150 khz to 80 MHz 150 khz to 80 MHz d = 1,2 P d = 1,2 P d = 1,2 P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people