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Summary of Contents for Impulse Dynamics Vesta Charger
- Page 1 Vesta Charger for OPTIMIZER Smart Mini ™ System INSTRUCTIONS FOR USE Part No.: 13-290-034-EU Rev. 00...
- Page 2 OPTIMIZER is a US registered trademark property of Impulse Dynamics. ® The Vesta Charger conforms to the essential requirements of the Radio Equipment Directive (RED) 2014/53/EU. The information provided in this document may change without prior notice. No part of this manual may be reproduced or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Impulse Dynamics.
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Page 3: Table Of Contents
Screens Displayed After the Detection of an Alert Condition ......... 8 1.6.5 Info Screens ......................10 Pairing the Vesta Charger with the OPTIMIZER Smart Mini IPG ........11 Charging the Vesta Charger ....................12 Charging the OPTIMIZER Smart Mini IPG ................ 13 1.9.1... - Page 4 Electromagnetic Emissions from the Vesta Charger ............28 APPENDIX II ............................... 31 Wireless Technology ........................31 Vesta Charger Wireless Nominal Specifications ............... 31 Quality of Service (QoS) for Wireless Technology ............32 Wireless Security Measures ....................33 Troubleshooting for Wireless Coexistence Issues ............33...
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Page 5: Explanation Of Symbols On Labels
EXPLANATION OF SYMBOLS ON LABELS Symbol Description CE Conformity marking, 0344 - Notified Body Number 0344 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Consult instructions for use Do not use if package is damaged Storage and transport temperature limits Date of manufacture Manufacturer... - Page 6 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 7: The Vesta Charger System
THE VESTA CHARGER SYSTEM Description The Vesta Charger is designed to charge the battery of the OPTIMIZER Smart Mini IPG with only minimal patient intervention while ensuring patient safety and maintaining proper operation of the IPG during the charging process. -
Page 8: Charging Method
Charging Method The charging method utilized by the Vesta Charger to charge the battery of the OPTIMIZER Smart Mini IPG is called inductive energy transfer. Since magnetic fields can penetrate human tissues with nearly no attenuation, inductive energy transfer is the only practical transcutaneous recharging method. -
Page 9: Features
Buzzer: An internal buzzer that produces beeping tones to inform the patient of a • condition that requires action Charging Wand: Wand containing a coil and circuitry used by the Vesta Charger for • charging as well as short-range communications with the OPTIMIZER Smart Mini IPG Radio Transceiver: Device used by the Vesta Charger for long-range communications •... - Page 10 Vesta Charger, when the AC Adapter is connected to the Vesta Charger and the battery charge level of the Vesta Charger is above 75%, or when the AC Adapter is charging the Vesta Charger and the AC Adapter current is less than 50 mA.
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Page 11: Screens Displayed When Paring With The Optimizer Smart Mini Ipg
1.6.2 Screens Displayed When Paring with the OPTIMIZER Smart Mini IPG 1.6.2.1 Charger/IPG Pairing Screen This screen is displayed whenever the Vesta Charger is actively pairing with the OPTIMIZER Smart Mini IPG. Figure 7: Charger/IPG Pairing Screen 1.6.2.2 Charger/IPG Pairing Success Screen This screen is displayed whenever the Vesta Charger has successfully paired with the OPTIMIZER Smart Mini IPG. - Page 12 IPG, this is the third screen displayed after pressing the Power Button on the Vesta Charger. The number of bars shown on the Vesta Charger Battery icon (on the left) and the IPG Battery icon (on the right) will vary depending on the current level of charge in each battery (see Tables 3 and 4).
- Page 13 OPTIMIZER Smart Mini IPG. The display of this screen is accompanied by 3 long beeping tones. If your Vesta Charger is unable to establish coupling with the OPTIMIZER Smart Mini IPG, this is the third screen that is displayed after pressing the Power Button on the Vesta Charger.
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Page 14: Screens Displayed After The Detection Of An Alert Condition
1.6.3.8 Charging IPG Temperature Error Screen This screen is displayed by the Vesta Charger whenever one of the following conditions occurs: • The reported temperature of the OPTIMIZER Smart Mini IPG at the beginning of the charging session is outside the accepted range. - Page 15 Abnormal Condition Error Screen This screen is displayed whenever an abnormal condition is detected in the OPTIMIZER Smart Mini IPG or the Vesta Charger. The display of this screen is accompanied by 3 long beeping tones. Figure 23: Abnormal Condition Error Screen 1.6.4.5...
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Page 16: Info Screens
1.6.4.6 Snooze Buzzer Alert Screen This screen instructs the patient to press the button on the Vesta Charger to silence the beeping tone associated with the activated alert. It is the screen that is displayed after the alert screen of a newly activated alert. -
Page 17: Pairing The Vesta Charger With The Optimizer Smart Mini Ipg
2. Place a pairing magnet (or a standard pacemaker magnet) to the left of the Power Button on the Vesta Charger. See Figure 29. Note: A Vesta Charger being used for the first time does not require the use of a magnet during the pairing process. -
Page 18: Charging The Vesta Charger
AC Adapter and the AC Adapter plugged into the wall outlet. This keeps the battery of the Vesta Charger fully charged and ready to be used the next time they need to charge their implanted OPTIMIZER Smart Mini IPG. -
Page 19: Charging The Optimizer Smart Mini Ipg
Warning: Failure to recharge the OPTIMIZER Smart Mini IPG as required may cause it to shut down when the battery is depleted, suspending CCM therapy delivery. Note: The Vesta Charger cannot be used to charge the OPTIMIZER Smart Mini IPG until the AC Adapter is disconnected from the Vesta Charger. - Page 20 (at least daily) until their implanted device is fully charged. 8. When the battery of the OPTIMIZER Smart Mini IPG is fully charged, the Vesta Charger will emit three short beeping tones and display the IPG Charging Successfully Completed screen (see Figure 37).
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Page 21: Early Termination Of Charging Session
Alternatively, the patient can remove the charging wand of the Vesta Charger from the implant site, which will cause the Vesta Charger to time out and shut off automatically. Note: During the charging process, the Vesta Charger monitors the temperature of the OPTIMIZER Smart Mini IPG. -
Page 22: Vesta Charger Placement When Not Being Used For Device Charging
If the Vesta Charger is not used to perform a charging session on the OPTIMIZER Smart Mini IPG within the time period set by the Optimizer Smart Mini Programmer application, the patient may see the Long Time Without Charging IPG alert screen (see Figure 41) displayed by the Vesta Charger. -
Page 23: Communications
Impulse Dynamics representative. 1.14 Call Doctor Alert Codes In addition to charging the OPTIMIZER Smart Mini IPG, the Vesta Charger is also able to notify the patient of an alert condition in the OPTIMIZER Smart Mini IPG that requires action. -
Page 24: Call Doctor Alert Code Attributes
When Alert Code 23 is displayed, it means that the battery voltage level in the OPTIMIZER Smart Mini IPG is less than 3.6 V. If the Vesta Charger displays this Alert Code, please charge the OPTIMIZER Smart Mini IPG battery as soon as possible to prevent CCM therapy from becoming suspended. -
Page 25: Fce Charger
Note: FCE Chargers are for clinical use only and are not to be assigned to patients. To obtain an FCE Charger, please contact your Impulse Dynamics representative. The FCE Charger is intended to be used in a clinical setting to charge a patient’s implanted... - Page 26 20 seconds, the Vesta Charger will emit 3 long beeping tones, display the Charging IPG Coupling Error screen, and then shut off. If this occurs, press the Power Button again to initiate a new charging session.
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Page 27: Charging The Optimizer Smart Mini Ipg In Unpaired Charge Mode
8. When the battery of the OPTIMIZER Smart Mini IPG is fully charged, the Vesta Charger will emit three short beeping tones and display the IPG Charging Successfully Completed screen (see Figure 48). The Vesta Charger will then shut off automatically. -
Page 28: Cleaning
Warning: DO NOT attempt to clean the electrical connector of your Vesta Charger. Warning: DO NOT submerge any part of the Vesta Charger in water. Damage to the unit may result. The Vesta Charger has limited protection against the ingress of water or humidity (ingress protection rating IP22). -
Page 29: Maintenance
Warning: No modification of this equipment is allowed. The battery inside the Vesta Charger is expected to have a service life of at least 5 years. If the Vesta Charger cannot fully charge an OPTIMIZER Smart Mini IPG after the charger battery has been fully charged, please contact your Impulse Dynamics representative to obtain a replacement charger. - Page 30 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 31: Electromagnetic Immunity
If essential performance is lost due to electromagnetic disturbances, the Vesta Charger shall not be able to charge any IPG. The Vesta Charger, part of the OPTIMIZER Smart Mini System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment. - Page 32 RF transmitters. If the measured field strength in the location where the Vesta Charger is used exceeds the applicable RF compliance level above, the Vesta Charger should be monitored to ensure normal operation. If an abnormal function is observed, additional measures may be necessary, such as relocating the Vesta Charger.
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Page 33: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Vesta Charger
Recommended separation distances between portable and mobile RF communications equipment and the Vesta Charger The Vesta Charger should be used in an electromagnetic environment with limited radiated RF noise. The customer or user of the Vesta Charger can help prevent electromagnetic interference by... -
Page 34: Electromagnetic Emissions
Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU The Vesta Charger, part of the OPTIMIZER Smart Mini System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment. - Page 35 Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU The Vesta Charger, part of the OPTIMIZER Smart Mini System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
- Page 36 - Collateral Standard: Electromagnetic disturbances – Requirements and tests The Vesta Charger, part of the OPTIMIZER Smart Mini System, is intended for use in an electromagnetic environment as specified below. The customer or user of the Vesta Charger must ensure that it is used within the specified environment.
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Page 37: Wireless Technology
APPENDIX II Wireless Technology RF wireless technology is used to transcutaneously transmit energy from the Vesta Charger to recharge the OPTIMIZER Smart Mini IPG at the 13.56 MHz ISM frequency. The transmission range is specified at a maximum of 4 cm (1.5 in) between the Charger’s coil and the IPG’s receiving coil. -
Page 38: Quality Of Service (Qos) For Wireless Technology
The requirements for the Quality of Service (QoS) vary depending on the use environment (operating room, recovery room, clinic, and home environment). The Vesta Charger will begin by displaying the IPG Data Download and IPG Data Download Success screens: After the data download has been completed, the Charging IPG Status screen is... -
Page 39: Wireless Security Measures
In this case, instruct the patient to attempt to charge their OPTIMIZER Smart Mini IPG with their Vesta Charger. If the patient is able to charge their implanted device successfully, then the alert screen should no longer be displayed by the Vesta Charger.
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