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1 2 | manual1 | Users Manual | 1.21 MiB |
2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 2/49 Manual 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 IntelliCap Drug Delivery and Monitoring System P P r r i i n n t t i i e e d d c c o o p p e e s s a a r r e e u u n n c c o o n n t t r r o o l l l l e e d d l l u u n n e e s s s s a a u u h h e e n n t t t t i i c c a a e e d d t t Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 3/49 Manual P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d User Manual November 2010 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics Table of Contents IntelliCap User Manual page 4/49 Manual 1. General Information ....................................................................... 6 Trademarks ........................................................................................ 6 2. Software License Agreement ........................................................... 7 Software Licence Agreement ................................................................. 7 3. Intended Use ................................................................................ 8 4. Contraindications ........................................................................... 8 5. Restrictions ................................................................................... 9 6. Product Description ........................................................................ 9 P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 7. IntelliCap System Components ...................................................... 13 7.1 Control Center PC ........................................................................ 13 Software .......................................................................................... 13 7.2 Start Up Unit ............................................................................... 14 7.3 Portable Unit ............................................................................... 15 Amber Module .................................................................................. 16 7.4 IntelliCap Capsule ........................................................................ 16 8. Data security and privacy ............................................................. 18 9. Warnings .................................................................................... 18 10. Cautions ..................................................................................... 19 11. Safety ........................................................................................ 19 11.1 Portable Unit Indicators ............................................................. 19 11.2 Control Center Indicators ........................................................... 19 12. Utilization of IntelliCap ................................................................. 21 13. Recovery and Disposal of the IntelliCap Capsule ............................... 22 14. Data Viewing Software ................................................................. 23 Starting the IntelliCap Software .......................................................... 23 15. Parts & Supplies .......................................................................... 25 16. Capsule Preparation ..................................................................... 26 17. Entering the pH Calibration Data .................................................... 27 18. IntelliCap Capsule Initialization ...................................................... 27 19. Pairing the Control Center to a PU .................................................. 30 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 5/49 Manual 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 20. Activating an IntelliCap Capsule ..................................................... 30 21. Pairing the Control Center to an IntelliCap Capsule ........................... 32 21.1 Manual Pairing of IntelliCap Capsule / Portable Unit / Control Center 32 21.2 Automatic Pairing on Activation ................................................... 33 22. Data Storage and Review .............................................................. 34 22.1 Changing the Data Log File ......................................................... 34 22.2 Exporting Current Data to an Excel File ........................................ 35 23. Commands to the IntelliCap Capsule .............................................. 35 23.1 Setting the Pill ID ...................................................................... 36 23.2 Shutdown an IntelliCap Capsule .................................................. 36 23.3 Advance to next program segment .............................................. 36 23.4 Cancel command to the PU ......................................................... 37 24. Maintenance of PU / CCU / SU unit ................................................. 37 Cleaning After Every Use .................................................................... 37 25. General Inspection Every Use ........................................................ 38 26. Service ....................................................................................... 38 27. Product Changes ......................................................................... 38 28. Technical Information ................................................................... 38 29. Label ......................................................................................... 39 29.1 Capsule ................................................................................... 39 29.2 Storage Vial ............................................................................. 40 29.3 Portable Unit ............................................................................ 41 29.4 Control Center Unit ................................................................... 42 29.5 Start-Up Unit ............................................................................ 43 29.6 Symbols .................................................................................. 44 30. IntelliCap Capsule Specifications .................................................... 46 31. Portable Unit Specifications ........................................................... 47 32. Start Up Unit Specifications ........................................................... 48 33. Document history ........................................................................ 49 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 6/49 Manual 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 1. General Information This user manual describes the constituent components and basic operation of the IntelliCap Drug Delivery and Monitoring System, alternatively referred to as the IntelliCap System. Trademarks IntelliCap is a trademark of Philips Microsoft Windows is a trademark of Microsoft Corporation Core2 is a trademark of Intel The IntelliCap System is manufactured by Koninklijke Philips Electronics Nederland BV acting through Philips Research acting through Medimetrics. Medimetrics Philips Research High Tech Campus 34 (WB.2-043) 5656 AE Eindhoven The Netherlands Telephone:
+31 40 27 49268
-------------------------------------------
Medimetrics Philips Research 345 Scarborough Road Briarcliff Manor, NY 10510 Telephone:
+1 914 945 6628 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 7/49 Manual 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 2. Software License Agreement Carefully read this SOFTWARE LICENCE AGREEMENT before continuing. By opening/using the Software you accept and agree to comply with the terms and conditions of this Agreement. If you do not agree with these terms and conditions, contact Medimetrics for directions on how to return your software package. Software Licence Agreement 1. Software: As used herein SOFTWARE shall mean the IntelliCap Data viewing software supplied with and designed for use with IntelliCap System products. 2. Grant of License: Medimetrics grants you the right to use its software, which may include online or electronic documents. 3. Upgrades: If the SOFTWARE is an upgrade, the same GRANT OF LICENCE rules apply as if the SOFTWARE were an original installation. 4. Copyright: the SOFTWARE (including any images, configuration files, documents, text, resource files, photographs, animations, video, audio, or music incorporated into the SOFTWARE) is owned by Medimetrics and is protected by European Copyright laws and international treaty provisions. Therefore, you must treat the SOFTWARE like any other copyrighted material (e.g., a book or musical recording) except that you may either (a) make one copy of the SOFTWARE solely for backup or archival purposes, or (b) transfer the SOFTWARE to a single hard disk provided you keep the original solely for backup or archival purposes. You may only copy the printed materials accompanying the SOFTWARE after obtaining written permission exclusively from Medimetrics. 5. Other restrictions: You may not rent or lease the SOFTWARE, but you may transfer the SOFTWARE and user documentation on a permanent basis provided you retain no copies and the recipient agrees to the terms of the AGREEMENT. You may not reverse engineer, decompile, disassemble, or otherwise reduce the SOFTWARE to a human-
perceivable form, nor permit anyone else to do so. You may not modify, distribute of create derivate works based upon the SOFTWARE in whole or in part without the written permission of Medimetrics. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 8/49 Manual 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 3. Intended Use The IntelliCap system is an in-vivo measurement system of pH and temperature in the gastrointestinal (GI) tract of humans and mammals, in order to facilitate delivery of a compatible compound in sections of GI tract, as a tool for premarket drug research. The IntelliCap system is used as a tool for premarket drug research. The IntelliCap system is to be operated by trained physicians and personnel. All persons using or operating the equipment shall receive instruction and training from a member of Medimetrics. This manual serves as a reference for operation, technical information, and standardization of procedures. 4. Contraindications The IntelliCap Capsule is an indigestible capsule-shaped object measuring 11 mm in diameter and 26.7 mm in length. Subjects who are unable to swallow the capsule or who present risk for retention of the capsule should be excluded for use. Further as the system operates with wireless RF communication the possibility for interference with implanted electro-medical devices should be avoided. The following contraindications apply:
Subjects with known or suspected gastrointestinal strictures, including (suspected) Crohns disease Subjects with swallowing disorders Subjects using acid reducing medication Subjects using NSAID s Subject with known cardiopulmonary or any other gastrointestinal disorders Subjects with ASA > 1 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 9/49 Manual 255 5. Restrictions 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 The IntelliCap Capsule shall not be loaded with toxic or poisonous substances The IntelliCap Capsule shall only be loaded with substances positively tested for compatibility and stability The IntelliCap Capsule shall not be ingested by subjects with pacemakers or other implanted electro-medical devices Subjects shall not be allowed to undergo MRI studies while the IntelliCap Capsule is in the body 6. Product Description Each IntelliCap system consists of one Control Center, one or more portable units and one or more (up to 8 connected on one frequency channel) IntelliCap capsules. The Control Center is a personal computer that manages the environment. It provides the user interface for programming, initialization, interactive control, monitoring and evaluation of IntelliCap operation. The system structure is shown in Figure 1. The Control Center communicates with each IntelliCap via a portable unit, which is placed in close proximity to the test subject. The portable units relay communication between IntelliCaps and the Control Center during the operation. The Control Center can communicate with multiple portable units. Nominally each portable unit addresses only one assigned pill. It is possible that more than one pill can be assigned to a given portable unit. This allows a single portable unit to handle more than one capsule in the body of a test subject. Additionally one capsule may communicate to more than one portable unit. This allows redundancy of receivers to reduce the chances of missed data packets. The IntelliCap itself is an ingestible compound-delivery capsule containing a medication compartment, actuator, sensors, and wireless communication under control of a microprocessor. The IntelliCap consists of an electronic compartment and a drug medication compartment. The electronic compartment consists of a pH sensor, an integrated programmable microprocessor with a wireless transceiver, an antenna and a temperature sensor, an electrical stepper motor and batteries. The medication compartment consists of a 275 l (nominal volume) drug Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 10/49 Manual 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 reservoir and a dispensing hole. The contents of the drug reservoir can be expelled by actuation of the stepper motor. Figure 1: Schematic diagram of the IntelliCap system and communication channels. A diagram of the IntelliCap capsule is shown in Figure 2. The diagram illustrates the mechanical layout of the capsule and identifies the main elements. The capsule house is made of a biocompatible polyethylene shell. A medication compartment is defined by the outer shell and flexible foil seal. An electrical motor pushes a piston forward thereby displacing the liquid drug out from an exit hole. The capsule is powered by a pair of primary cell silver oxide batteries. The batteries are not rechargeable and each IntelliCap capsule is a single use device. The capsule contains a pH sensor and a temperature sensor. A wireless transceiver is included for data communication between the IntelliCap inside the body and a portable unit (PU) which the patient carries outside the body. The IntelliCap can be programmed to deliver a specific volume of drugs in a pre-set time frame, triggered by a change in pH. This change of pH presumably reflects transit of the IntelliCap from stomach (pH 1-4) to Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 11/49 Manual 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 duodenum (pH 7-8) and further on transit form ileum (pH 7-8) to cecum
(pH 4-5). The IntelliCap can be programmed to expel its contents triggered by a change in pH, after a given programmable time at a given programmable rate. The IntelliCaps status (time, temperature, pH, expulsion status, battery voltage) can be monitored on a control station that is wirelessly connected to the IntelliCap through a portable unit worn by the test subject. The IntelliCap can be programmed to perform various release profiles such as single burst profile, dual burst profile or sustained release profile, triggered by a change of pH of >2 units. Figure 2: Diagram of the IntelliCap capsule showing mechanical layout and the main components. The portable unit is the means for communication with the IntelliCap during an experiment. Communication between an IntelliCap and a portable unit uses RF frequencies nominally around 400-440 MHz (MICS band 402-405MHz or ISM band 432-434MHz). This range is chosen to limit attenuation of high frequency RF signals in the body. Since RF signals are strongly attenuated through the body, the portable unit must be in close proximity to the test subject. The portable unit has on-board recording memory so that all data can be retrieved even if real-time data transmission is interrupted. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 12/49 Manual 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 The IntelliCap and the portable unit are battery powered devices and are designed in such a way that the operational lifetime is at least 48 Hours. In order to have an optimal power savings the communication links (Pill Portable Unit and Portable Unit Control Center) are not continuously present. In a normal operational situation the Pill measures data once in 10 seconds and sends it to the portable unit, and eventually receives commands back. The portable unit exchanges data with the Control Center also once in 10 seconds. In normal operation commands from the control center are transmitted via the portable unit to the Pill. Due to substantial signal loss of RF signals propagating in body tissue, the signal strength is weak and pushes detection limits. Thus there exists the possibility for lost transmissions. Experimental design and software operation are made such that the loss of occasional transmissions shall not compromise the validity of the experiment (e.g. one out of six data packets received i.e. one reliable data packet per minute). Communication between the Control Center and a portable unit is accomplished by an AMBER module, which uses a well accepted wireless communication protocols in ISM (free bands). Separate modules are available operating at 868MHz or at 2.4 GHz. The used Amber module is a commercially one that works in a so-called transparent mode (all communication firmware already build in) and has a CE certification. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 13/49 Manual 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 7. IntelliCap System Components 7.1 Control Center PC The system is primarily controlled and operated from a notebook PC called the Control Center (CC). Software will be pre-installed by Medimetrics personnel who will check the specifications of the commercial notebook PC for compatibility. A notebook PC shall meet the following minimum requirement:
CPU 1.6GHz, RAM 2GB, Com ports: 4 USB, Operation System Microsoft Windows XP Professional Service Pack 3, with Microsoft .NET Framework 3.5 installed. For example, control Center operation has been verified on a commercial notebook PC with the following characteristics:
Processor:
RAM:
Com ports:
Intel Core2 Duo CPU P8700 @ 2.53GHz 3.45 GB 4 USB ports Operating System: Microsoft Windows XP Professional, Service Pack 3 Software The Data viewing software application is specifically designed to be used with the IntelliCap System. Additional information concerning detailed operation of the software may be found in separate documentation not included with this system user manual. Basic operation of the IntelliCap System is covered here. With the Data viewing software the user is able to:
Initialize an IntelliCap Capsule with the behavior profile Establish a data communication link with a Portable Unit Activate an IntelliCap Capsule Enter pH calibration data for a given IntelliCap Capsule Continuously present the following parameters graphically and/or numerically on screen:
- pH Data: ADC reading and calibrated value
- Temperature of IntelliCap Capsule
- Battery reading of IntelliCap Capsule Command an IntelliCap Capsule to advance to the next program segment Shut down an IntelliCap Capsule Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 14/49 Manual 424 425 426 Import experiment data from previous data log files Export experiment data for analysis in external programs 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 7.2 Start Up Unit The IntelliCap Capsules are initialized and activated by a Start Up Unit
(SUU). The SUU is connected to the Control Center PC by a USB cable. The SUU incorporates a start up coil for inductively coupling energy to an IntelliCap capsule. Upon start up the IntelliCap Capsule closes a switch for connection to its internal battery power. The SUU is able to communicate wirelessly to an IntelliCap capsule. This communication link is also used to P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d initialize the capsule. Initialization is the process of loading the capsule with the desired behavior profile. A photograph of a Start Up Unit is shown in Figure 3. Figure 3: Photograph of a Start Up Unit used to activate and initialize Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved IntelliCap Capsules. 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 15/49 Manual 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 7.3 Portable Unit The Portable Unit (PU) is the main means for communication with an IntelliCap capsule during the execution of an experiment. The PU can communicate with both the IntelliCap capsule and the Control Center. As the communication range of the IntelliCap Capsule is limited a transceiver unit must be placed near the test subject. A photograph of a Portable Unit is shown in Figure 4. Figure 4: Photograph of a Portable Unit used for communication between an IntelliCap Capsule and the Control Center PC. An Amber USB Adapter is used for wireless communication between the Control Center PC and a Portable Unit. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 16/49 Manual 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 The PU is a relatively small and lightweight unit that may be worn by a test subject on a belt or specially designed holder. The holder may be fit comfortably about the waist of a person and contains a pocket for housing a PU. Data is stored locally on the PU and is additionally relayed to the Control Center for immediate visualization and analysis. Data stored in the PU memory is primarily for redundancy and to collect data when the subject exits the test environment. The data can be downloaded by direct connection via USB cable between the PU and Control Center. This operation is intended to occur after the end of an experiment as the PU cannot receive data from an IntelliCap capsule while downloading data via the wired connection. Amber Module An Amber Wireless M-Bus USB Adapter AMB8465 (868 MHz) or AMB2560 (2.4 GHz) is connected to the Control Center PC. The purpose of the Amber module is for low power wireless communication to the Portable Unit. The Portable Unit is configured with a matching module for wireless communication with the Control Center PC. The USB Adapter is a product of Amber Wireless GmbH, Colonge, Germany. The Amber USB Adapter and Control Center PC have been pre-configured for operation with the IntelliCap System. A photograph of an Amber USB Adapter is shown in Figure 4 as well. 7.4 IntelliCap Capsule The purpose of the IntelliCap Capsule is to measure conditions of its local environment and to deliver the contents of a medicine reservoir. The IntelliCap Capsule is prepared by loading the medicine reservoir with the target medication and initializing it with the desired behavior profile. The IntelliCap Capsule is also calibrated for accuracy of the pH readings. The capsule is activated at a Start Up Unit and then used for an experiment. The capsule is swallowed by a test subject and passes naturally through the digestive tract. It is excreted. As needed the IntelliCap capsule will be recovered after excretion by the test subject. The recovered capsule can be cleaned and observed for properties such as condition of the medicine Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 17/49 Manual 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 reservoir or post-recovery calibration of the pH sensor. A photograph of an IntelliCap Capsule is shown in Figure 5. Figure 5: Photograph of an IntelliCap Capsule used for drug delivery and monitoring in a test subject. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 18/49 Manual 556 557 558 559 560 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 8. Data security and privacy The IntelliCap System provides a secure repository for your information. The Control Center PC contains an encrypted hard drive and can only be accessed by an authorized user through password entry. The Data viewing Software stores data in a log file and can output data to a formatted Excel file. Collected data relates specifically to an individual test subject. Local laws governing the privacy and handling of data shall be followed. Data files should be noted by subject number only and should never contain direct information on the name or other personal information of the test person. 9. Warnings Clinical use of the IntelliCap System is restricted to trained personnel. Components and software of the IntelliCap System are optimized for use together. DO NOT CONNECT OTHER MACHINES, DEVICES TO THE START UP UNIT, PORTABLE UNIT, CONTROL CENTER PC OR ITS ACCESSORIES because damage to IntelliCap system, devices, the user or the patient may occur. NEVER USE THE PORTABLE UNIT ON A PATIENT WHEN CONNECTED TO THE MAINS FOR CHARGING OR ANY OTHER REASON. SERIOUS INJURY TO THE PATIENT MAY OCCUR. Safe and effective use of this device requires proper set-up and operation by trained personnel. The use of other cables and/or power supplies can cause damage to the IntelliCap System, the devices, the user or the patient. The IntelliCap System should only be used by trained personnel. Risk of electrical shock; do not attempt to service electrical components; refer servicing to qualified personnel. When handling the IntelliCap Capsule the operator shall put on a fresh pair of gloves. Failure to observe this procedure risks transmission of microbial contaminants to the patient who swallows the IntelliCap Capsule. After its use the IntelliCap Capsule shall not be reused. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 19/49 Manual 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 10. Cautions Read all instructions prior to use. Physicians responsible for using the IntelliCap System must be trained in the system and be aware of the inherent risks of misinterpretation of the collected and displayed parameters. Do not use if any of the components is visibly opened or damaged. Check all parts prior to use. 11. Safety P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d Safety features for the IntelliCap System are monitored and controlled by internal hardware and software checks. These features provide an independent mechanism to monitor and react to system faults. Indications of system status are provided both at the Portable Unit and from the Software operating on the Control Center PC. 11.1 Portable Unit Indicators The Portable Unit has LED indicator lights to monitor status and display to the subject or system operator. The Portable Unit may have the following indications:
Power On/Off;
- When power is switched on and the Portable Unit operating, the Power LED will be will be constantly lit.
- When power is switched off, the Power LED will be off. WARNING: NEVER USE THE PORTABLE UNIT ON A PATIENT WHEN CONNECTED TO THE MAINS FOR CHARGING OR ANY OTHER REASON. SERIOUS INJURY TO THE PATIENT MAY OCCUR. 11.2 Control Center Indicators Software running on the Control Center provides indicator messages to the operator to inform of system status and operation. The following messages should be monitored:
Status Portable Unit;
Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 20/49 Manual 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646
- The main Data viewing form shows the status of the portable unit in a line in the top grouping see for example Figure 6.
- DestinationNetworkUnreachable: Communication with the network device cannot be established. The operator should check the Amber Unit and/or settings in the Config dialog box.
- TimedOut: Communication with the Portable Unit cannot be established. The operator should check the Portable Unit and/or settings in the Config dialog box.
- NotAvailable: Communication with the Portable Unit cannot be established. The operator should check the Portable Unit and/or settings in the Config dialog box.
- Available: Communication with the Portable Unit is operating normally. Pill Activated message box;
- When an IntelliCap is successfully activated at the Start Up Unit a message box pops up on the screen. The operator should click the OK button to dismiss. P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 21/49 Manual 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 12. Utilization of IntelliCap The IntelliCap system is used for investigative studies with test subjects. The test subjects are evaluated for inclusion in the study. An attending physician nurse or other medical personnel trained in the use of the IntelliCap system directs the subjects for their use and interaction with the IntelliCap system components: the capsule, the portable unit, the belt, and any other ancillary equipment. Additionally the attending medical personnel are assisted by Medimetrics personnel with the set-up and operation of the IntelliCap system. The exact procedures will vary with each study as described in the protocol. Typical actions for use of the system are described below. Medimetrics personnel set up the IntelliCap system in the study environment Medimetrics personnel prepare the capsules for use including initialization, pH-sensor calibration, and activation of capsules A portable unit is prepared by Medimetrics personnel and placed into a belt The belt is given to the test subject for fitting around the abdomen Activated capsules are handed to the attending medical personnel Attending medical personnel provides the capsule to the test subject Test subjects swallow the capsule along with a glass of water Data is recorded at the control center PC The subject remains in a defined area near the control center PC Manual commands may be given from the control center PC to control action of the capsule if called for in the study design Depending on the study design the test subject may be allowed to leave the test area after a certain period of time. While the capsule is still in the body the belt with portable unit shall still be worn. The subject may remove the belt with portable unit for short periods of time for clothing change, bathing, etc. The belt and portable unit should not be submerged in water or worn in the shower. The belt with portable unit may be removed for sleeping and placed close to the subjects bed The subject may be requested to recover the capsule from feces after a bowel movement After the capsule is recovered from feces the belt may be removed Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 22/49 Manual 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 The subject will report back to attending study personnel to confirm exit of the capsule from the body. At this time the belt and portable unit are returned. WARNING:
THE INTELLICAP SYSTEM IS EXCLUSIVELY FOR INVESTIGATION PURPOSES FOR USE IN A RESEARCH SETTING UNDER A PROPERLY APPROVED PROTOCOL. ALL SYSTEM COMPONENTS MUST BE RETURNED TO MEDIMETRICS PERSONNEL AT THE CONCLUSION OF THE STUDY. 13. Recovery and Disposal of the IntelliCap Capsule In most cases the study protocol aims to recover the used IntelliCap capsule from the feces after excretion. As part of instruction test subjects will be taught how to recover capsules from the feces. In case the subject is allowed to leave the study premises ancillary equipment will be provided along with instructions on how to recover, isolate, and package the capsule for return to attendant personnel. A clean sealable container will be provided to house the recovered capsule. Any recovered capsule must be returned to attendant personnel. Medimetrics will take possession of used capsules and will process and dispose of the capsule in compliance to applicable regulations. WARNING: THE INTELLICAP CAPSULE IS A SINGLE USE DEVICE. NO REUSE IS POSSIBLE. THE RECOVERED CAPSULE REPRESENTS A HAZARD AS BIOLOGICAL MATERIAL MAY BE ETRAINED. FURTHER THE CAPSULE MAY HOLD NON-EXPELLED DRUG SUBSTANCE THAT MAY POSE ADDITIONAL HAZARDS. MEDIMETRICS WILL TAKE POSSESSION OF PROCESS AND DISPOSE OF ALL USED CAPSULES. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 23/49 Manual 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 14. Data Viewing Software The IntelliCap system is designed to work with execution and control managed by a Control Center Personal Computer. A software application designed for the IntelliCap System is pre-installed on the Control Center. The software application is named PCApplications.exe. A shortcut to directory is provided on the desktop. Further details concerning the software are included in a separate IntelliCap Software manual. Instructions in this user manual cover the primary operations used in an IntelliCap System experiment. Starting the IntelliCap Software 1. Locate the shortcut on the desktop named for example PCApplications 2.0.0.NN, where NN is the current version number of the software. In case multiple versions exist and no other instructions are present use the latest version with the largest revision number. Open the folder by double clicking the icon. 2. Locate the file named PCApplications.exe. 3. Launch the IntelliCap Software by double clicking the application icon. 4. A window opens titled for example Data viewing [PUnit aa][Local bb] where aa is the assigned IP address of the Portable Unit and bb is the assigned IP address of the current window. In most cases connection is made to the Portable Unit with the Amber module operating on a serial COM port. When configured for this operation the window title is for example Data viewing [PUnit serial COMn]
where n is the assigned COM port of the Amber USB adapter. The current software limits the maximum COM port number to 9. 5. Configuring and operating the IntelliCap System through the software interface is described in below. Note: Multiple instances of the IntelliCap data viewing software can be opened simultaneously. This allows control of more than one portable unit from one PC. There is a one to one correspondence between an open Data viewing window and an active Portable Unit. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 24/49 Manual 752 753 754 755 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 The main window for the IntelliCap System software is the Data viewing form. An example of this form and location of the main elements are illustrated in Figure 6. This main Data viewing form is groups into the following main areas:
Title Bar: Windows title bar. Configuration Control: Grouping of information and control buttons to configure the Control Center for pairing with external equipment, storing data, calibrating pH, and controlling Experiment Events. Graphical Data Display: Current data is presented in graphical form. One data type at a time is displayed as selected from the check boxes. User Annotation Box: The use may add a text line annotation into the log file. Reporting Text Box: Actions and received data are reported in this text box with a time stamp. Command Buttons: Actions that may be commanded from the Control Center. Title bar Configuration Control Graphic Data Control User Annotation Box Reporting Text Box Commands line Figure 6. Example of the Data viewing form that is the main window for the IntelliCap System software. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 25/49 Manual 789 790 791 792 793 794 795 15. Parts & Supplies The IntelliCap System consists of several parts. Additionally, different accessories are available. These accessories are OPTIONAL. PRODUCT CODE AND UNIT DESCRIPTION Part number Description Number used per set up PARTS Control Center PC Personal Computer with installed 1 IntelliCap Software Amber adapter USB dongle for communication to the 1 per PU Portable Unit(s) Start Up Unit Electronic unit for initialization and 1 activation of IntelliCap capsules Portable Unit (PU) Electronic unit for communication with Up to 4 the IntelliCap Capsule and Control Center IntelliCap Capsule Swallowable capsule for monitoring and Up to 4 User Manual IntelliCap System printed manual drug delivery ACCESSORIES 1 Calibration buffers Fluids for calibration of the pH sensor 1 to 3 Gloves Gloves for handling of IntelliCap Capsules Holster for PU Wearable holster for holding the PU 1 per subject near the body of a subject Tweezers Tweezers to for handling of IntelliCap 70% IPA wetted Capsules wipes Wipes for cleaning capsule body after 796 calibration Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 26/49 Manual 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 16. Capsule Preparation The IntelliCap Capsule is manufactured, calibrated, and prepared for use in an experimental study. The initial pH calibration and loading of the medicine reservoir with the target payload are outside the scope of this user manual. The corresponding procedures are covered in separate standard operations procedure technical documents. A data sheet
(produced within the calibration process) accompanies each IntelliCap capsule. The IntelliCap Capsule data sheet contains information including:
IntelliCap Capsule serial number IntelliCap Capsule ID number used for programming and reporting Behaviour profile and communications frequency (or channel) Initial pH calibration Medicine payload information including type and weight Capsules are delivered in dedicated storage vials as shown in Figure 7. Figure 7: IntelliCap capsule and the storage vial. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 27/49 Manual 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 853 854 855 856 857 858 859 860 861 862 863 864 865 866 867 868 869 17. Entering the pH Calibration Data The pH calibration data can be entered at any time through the Data viewing application installed on the Control Center PC. The Control Center does not have to be connected to external equipment such as the Start Up Unit or a Portable Unit. Nor does the given IntelliCap Capsule need to be active. The pH calibration data is stored in the directory containing Data viewing software PCApplication.exe in a file named pHCalibration.csv. The pH calibration data is applied to all data displayed or exported according to ID of capsules. Data from the calibration file is read every time the Data viewing application is launched. So the calibration data does not have to be entered each time a Data viewing application window is opened. To enter or override the pH calibration data execute the following:
1. Open the directory PCApplications and launch the Data viewing application titled PCApplications.exe 2. Open the pH Calibration form by clicking the Calibrate button located in the upper control group. 3. Enter the ID of the IntelliCap Capsule. The ID number is given on the data sheet accompanying the IntelliCap Capsule. It is an integer between 0 and 255. 4. The pH data may be calibrated by 1, 2, or 3 points. Start entering data for Point 1 by clicking the check box and entering data for the pH DAC value and pH value. 5. Proceed to enter data for Points 2 and 3 if available. The order in which the data is entered does not matter. That is, for example, there is no assumption that Point 1 is the smallest value. 6. Click Ok. 18. IntelliCap Capsule Initialization The IntelliCap Capsule comes loaded with a pre-determined behaviour profile and operating communication channel. This behaviour profile may be changed if desired by the operator. The process of changing or programming the IntelliCap Capsule behaviour profile is called Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 28/49 Manual 870 871 872 873 874 875 876 877 878 879 880 881 882 883 884 885 886 887 888 889 890 891 892 893 894 895 896 897 898 899 900 901 902 903 904 905 906 Initialization. To initialize an IntelliCap Capsule the system must be configured with the following components:
Control Center PC with IntelliCap data viewing application, PCApplications.exe pre-installed Start Up Unit connected to the Control Center PC by USB cable USB cable connected between the Control Center and Start Up Unit IntelliCap capsule The procedure to initialize the IntelliCap Capsule and change the behaviour profile is as follows:
1. Open the directory PCApplications and launch the Data viewing application titled PCApplications.exe 2. Open the communications Configuration form by clicking the Config button located in the upper control group. 3. In the Portable Unit control group click the radio button titled Portable Unit Serial. Select the appropriate COM port from the drop down list, for example COM8. 4. Click Ok. 5. In the upper control group Status Portable Unit changes to Available. 6. Open the start up unit by removing the cover. 7. Place the IntelliCap Capsule while in the storage vial into the Start Up Unit. The pH sensor window (ISFET) of the IntelliCap Capsule should face towards the center of the start up coil as shown in Figure 8. Place the cover back on the Start Up Unit. 8. The command button group is at the bottom of the window. Click Initialize Pill. 9. Choose the desired behaviour segments from the drop down lists in the InitializationForm. 10. 11. Click Initialize. After a few seconds the IntelliCap Capsule starts up. Capsule activation is reported in the text box of the Data viewing form with a message such as: Activation packet: [Id: 147, Frequency 402.45
(MICS), Battery level: 3, Initialized: True, Profile segments: 1 0 1 0]
12. Next an acknowledgement of initialization is reported in a message box that pops up with a message such as: Pill initialized. Id: 147, Freq: 402.45 (MICS). Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 29/49 Manual 13. 14. Click Ok to dismiss the message box. Initialization is also reported in the text box of the Data viewing form with a message such as: InitializeAck Packet:
[segments: 1, 0, 1, 0, frequency 402.45 (MICS)]
15. Next the IntelliCap Capsule shuts down and is reported in the text box with a message such as: Deactivation packet: [Id: 147, Motor Steps: 0, Temperature 10, Battery Level 3]
16. The IntelliCap capsule was successfully initialized
(programmed for the behaviour profile). 17. If the messages were not reported successfully or as desired the process may be repeated. Note: After shut down the IntelliCap Capsule cannot be immediately restarted. Wait 10 minutes after shut down before attempting to Initialize or Activate an IntelliCap Capsule after shut down. P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d Figure 8: Picture of IntelliCap Capsule in a storage vial on the SUU properly placed for capsule Initialization or Activation. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 30/49 Manual 944 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 973 974 975 976 977 978 19. Pairing the Control Center to a PU The basic set up of the IntelliCap system is shown in Figure 1. Typically there is a one-to-one pairing of a Portable Unit (PU) with an IntelliCap Capsule. Further there must be a one-to-one pairing of an active application window at the Control Center with a PU. So for example if the Control Center is controlling 3 PUs then 3 instanced of the Data viewing application, PCApplications.exe, will be running. The application window is paired to PU as follows:
1. Open the directory PCApplications and launch the Data viewing application titled PCApplications.exe 2. Connect an Amber USB dongle to the Control Center PC by inserting it into an available USB port. 3. Open the communications Configuration form by clicking the Config button located in the upper control group. 4. In the Portable Unit control group click the radio button titled Portable Unit Serial. Select the appropriate COM port from the drop down list, for example COM5. 5. Click Ok. 6. In the upper control group Status Portable Unit shows Not Available when the Portable Unit is not turned on. 7. Turn on the power to the Portable Unit that is matched to the Amber USB Adapter connected to the COM port selected in step 4. 8. In the upper control group Status Portable Unit changes to Available. 9. Repeat steps 1-8 for all desired Portable Units. Do not close the Data viewing application window for the previous application/PU pair. 20. Activating an IntelliCap Capsule The IntelliCap Capsule is shipped in an inactive state consuming no power. The process of starting up an IntelliCap Capsule and connecting it to its internal power source is called Activation. To activate an IntelliCap Capsule the system must be configured with the following components:
Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 31/49 Manual 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 Control Center PC with IntelliCap data viewing application, PCApplications.exe pre-installed Start Up Unit connected to the Control Center PC by USB cable USB cable connected between the Control Center and Start Up Unit IntelliCap capsule The procedure to activate the IntelliCap Capsule and change the behavior profile is as follows:
1. Open the directory PCApplications and launch the Data viewing application titled PCApplications.exe 2. Open the communications Configuration form by clicking the Config button located in the upper control group. 3. In the Portable Unit control group click the radio button titled Portable Unit Serial. Select the appropriate COM port from the drop down list, for example COM8. 4. Click Ok. 5. In the upper control group Status Portable Unit changes to Available. 6. Open the start up unit by removing the cover. 7. Place the IntelliCap Capsule while in the storage vial into the Start Up Unit. The pH sensor window (ISFET) of the IntelliCap Capsule should face towards the center of the startup coil. Place the cover back on the Start Up Unit. 8. The command button group is at the bottom of the window. Click Activate Pill. 9. After a few seconds the IntelliCap Capsule starts up. Capsule activation is reported in a message box that pops up with a message such as: Pill activated. (id: 147) 10. 11. Click Ok to dismiss the message box. In addition the activation packet is reported in the text box of the Data viewing form with a message such as: Activation packet:
[Id: 147, Frequency 402.45 (MICS), Battery level: 3, Initialized:
True, Profile segments: 1 0 1 0]
12. Note the Frequency and Pill ID of the IntelliCap Capsule. This information should match the data sheet provided with the capsule. This information is needed to pair the IntelliCap Capsule to the Control Center through a Portable Unit. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 32/49 Manual 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 13. Receipt of the activation packet automatically causes the Start Up Unit to switch to the proper channel for communication with the IntelliCap Capsule. 14. Depending on the behavior profile programmed onto the capsule, there will be a delay and then monitor packets will be received at the Control Center. The data will be reported in the text window and the graph updated every time a packet is received. 15. The IntelliCap Capsule is activated and continues to operate according to the programmed behavior profile. Note: After shut down the IntelliCap Capsule can not be immediately 1027 restarted. Wait 10 minutes after shut down before attempting to Initialize 1028 or Active an IntelliCap Capsule after shut down. 1029 1030 1031 1032 1033 21. Pairing the Control Center to an IntelliCap Capsule The basic set up of the IntelliCap system is shown in Figure 1. Typically 1034 there is a one-to-one pairing of a Portable Unit (PU) with an IntelliCap 1035 Capsule. Further there must be a one-to-one pairing of an active 1036 application window at the Control Center with a PU. In order to view data 1037 from a given IntelliCap Capsule it must be paired with both the PU and 1038 the Data viewing application on the Control Center. This pairing is 1039 typically done manually where the Frequency and Pill ID of the IntelliCap 1040 Capsule is known. 1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 21.1 Manual Pairing of IntelliCap Capsule / Portable Unit / Control Center 1. Pair the Control Center Data viewing application to desired Portable Unit as described above. Leave this Data viewing window open. 2. Activate an IntelliCap Capsule with the Start Up Unit as described above. Note the channel and Pill ID of the IntelliCap Capsule. 3. Switch focus to the Data viewing window paired with the desired Portable Unit. 4. Open the communications Configuration form by clicking the Config button located in the upper control group. 5. On top of the form enter the Pill ID. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 33/49 Manual 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 1063 1064 6. In the Portable Unit field grouping click the check box at Change PU frequency. 7. Choose the frequency from the drop down list. 8. Click Ok. 9. After a delay of up to 20 sec confirmation of the frequency selection is reported in a message box with a message such as Set frequency of Portable Unit. Ack received. Frequency: n, where n is the channel number selected. 10. 11. Click Ok to dismiss the message box. Data packets from sent from the IntelliCap Capsule will be reported in the text box and the graph updated. Note: The Pill ID is used to filter the data displayed in the Data 1065 viewing window. Alternatively the Pill ID may be set to Any. In this case 1066 data from any IntelliCap Capsule received by the PU will be reported in 1067 the application. The IntelliCap Capsule must be operating at the same 1068 frequency the PU is set to be received. 1069 1070 It is possible to automatically pair the Control Center and Portable Unit 1071 to an IntelliCap Capsule. To do this the Portable Unit must be able to 1072 receive wireless data from the IntelliCap Capsule while it is on the Start 1073 Up Unit. 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 21.2 Automatic Pairing on Activation 1. Link the Control Center PC to a Portable Unit as described above. 2. Pair a Control Center Data viewing window to the Portable Unit as described above. 3. Place focus on the Data viewing window associated with the Portable Unit. 4. Click Activate Pill. 5. Acknowledgment of the packet is confirmed in the text box with a data line such as [date time]: Portable unit Ack packet: 5. 6. Leave the Data viewing window associated with the PU open. 7. Launch another Data viewing window for the Start Up Unit and Activate the IntelliCap Capsule as described above. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 34/49 Manual 1087 1088 1089 1090 1091 1092 1093 8. The activation packet should be received and reported in both the Data viewing window paired with the Start Up Unit and the Data viewing window paired with the Portable Unit. 9. Data packets sent by the IntelliCap Capsule are recorded and reported in both Data viewing windows. Note: When the Activate Pill command is sent to the Portable Unit that 1094 Portable Unit changes to Channel 0 and waits for an activation packet. 1095 The Portable Unit continues to wait for the activation packet until another 1096 command is sent including for example the Cancel PU command. 1097 1098 1099 1100 22. Data Storage and Review All data received or actions commanded are reported in the Data 1101 viewing application on the Control Center PC in the text box near the 1102 bottom of the window. The last several lines of data are displayed and 1103 earlier data can be examined by control of the scroll bar. Further all 1104 messages displayed in the text box are recorded in a log file. The log file 1105 is a text file stored on the PC. By default the log file is named 1106 receivedPackets.txt and is stored in the same directory that contains the 1107 application file PCApplications.exe. The operator has the option of 1108 changing the name and location of the log file. Further the operator may 1109 export data to an Excel file for further analysis and data processing. 1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 22.1 Changing the Data Log File 1. Place focus on an open Data viewing application window. 2. Near the top of the window click the Switch button. 3. A file selection form opens. Enter or select the desired file name. 4. Click Open. 5. The location and name of the experiment log file is updated in the text box after Experiment: near the top of the Data viewing form. Note: Changing the name of the data log files clears any past data 1120 from active memory and display. If an existing log file is chosen data from 1121 that file is read and displayed in the graph. In this manner past Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 35/49 Manual 1122 experiment data may be reviewed and additional data may be appended 1123 to the log file. 1124 1125 1126 1127 1128 1129 1130 1131 1132 22.2 Exporting Current Data to an Excel File 1. Place focus on an open Data viewing application window. 2. Near the top of the window click the Export to Excel button. 3. A file selection form opens. Enter or select the desired file name. 4. Click Save. 5. The current data is saved in *.csv file. Note: The current pH calibration values are applied to the pH data. 1133 New calibration or drift values can be applied to data in current memory. 1134 The new calibration and drift values are applied to data displayed on the 1135 pH-value (pH) graph but do not change data in the log file. They are 1136 applied to the data exported to the Excel *.csv file. 1137 1138 1139 1140 23. Commands to the IntelliCap Capsule There are few of commands that can be sent to the IntelliCap Capsule 1141 from the Control Center. In order to send a command to an IntelliCap 1142 Capsule the Data viewing window must be paired to the capsule through a 1143 Portable Unit. Pairing the Control Center to an IntelliCap Capsule is 1144 described above. In order to send a command to an IntelliCap Capsule 1145 the correct Pill ID must be set. After setting the Pill ID the command may 1146 be issued from the Data viewing form. Available commands are grouped 1147 with the action buttons at the bottom of the window. Due to the power 1148 saving communications protocol a command is sent to the Portable Unit 1149 only after a monitor data packet is received or after a maximum wait 1150 period of about 20 sec. Further the command is held by the Portable Unit 1151 and send to the IntelliCap Capsule only after the capsule reports a data 1152 packet. Thus there is a built-in delay between sending the command from 1153 the Control Center and execution by the IntelliCap Capsule. 1154 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 36/49 Manual 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 23.1 Setting the Pill ID 1. Place focus on the Data viewing application window paired with the desired Portable Unit. 2. Open the communications Configuration form by clicking the Config button located in the upper control group. 3. On top of the form enter the Pill ID. 4. Click Ok. 5. The active Pill ID number is displayed in the top group on the right side. 23.2 Shutdown an IntelliCap Capsule Shutdown of an IntelliCap Capsule disconnects the power source from 1167 the capsule electronics. The IntelliCap Capsule becomes inactive. 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 1. Place focus on the Data viewing application window paired with the desired Portable Unit. 2. Confirm or set the Pill ID for the desired IntelliCap Capsule. 3. At the bottom of the Data viewing form Click Shutdown Pill. 4. Acknowledgement of command receipt at the Portable Unit is reported in the text box with a message such as [date time]:
Portable unit Ack packet: 4. 5. A data monitor packet is received and displayed in the text box. 6. A deactivation packet is received and displayed in the text box. 7. The IntelliCap Capsule is inactive. 23.3 Advance to next program segment The IntelliCap Capsule executes a behavior profile as programmed 1181 during Initialization. At any time the user may advance execution to the 1182 next program segment. 1183 1184 1185 1186 1187 1188 1189 1190 1. Place focus on the Data viewing application window paired with the desired Portable Unit. 2. Confirm or set the Pill ID for the desired IntelliCap Capsule. 3. At the bottom of the Data viewing form Click Advance next segment. 4. Acknowledgement of command receipt at the Portable Unit is reported in the text box with a message such as [date time]:
Portable unit Ack packet: 8. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 37/49 Manual 1191 1192 1193 1194 1195 1196 1197 5. A data monitor packet is received and displayed in the text box. 6. After a pause acknowledgement of program advance is reported in the text box with a message such as: MonitorAdvanceSegment packet: [Id: 147, CurrentSegmentCounter: 1, AutoAdvance: False]
23.4 Cancel command to the PU Commands are first held at the Control Center and later at the Portable 1198 Unit before execution by the IntelliCap Capsule as described above. This 1199 command caching gives opportunity to cancel a command before it is sent 1200 to the IntelliCap Capsule. P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 1211 1. Place focus on the Data viewing application window paired with the desired Portable Unit. 2. Confirm or set the Pill ID for the desired IntelliCap Capsule. 3. At the bottom of the Data viewing form Click Cancel PU. 4. If the cached command is successfully canceled, a confirmation message is reported in a pup-up window. Otherwise, Nothing canceled is reported. 24. Maintenance of PU / CCU / SU unit The following lists the recommended maintenance procedures should 1212 be followed:
1213 1214 1215 Cleaning After Every Use The IntelliCap System and its accessories should be cleaned after each 1216 use and/or after any spill of liquids. For routine cleaning, use only mild 1217 detergents and a humid soft cloth. The Portable Units should be 1218 disinfected after every use. For disinfecting wipe the equipment with an 1219 isopropyl alcohol solution or other proper surface disinfectant. 1220 1221 CAUTION: Ensure electrical power is OFF and line cord is disconnected 1222 from power source prior to cleaning. Do not use abrasive cleaning agents. 1223 Do not use solvents or strong alcohol solutions. Do not immerse any part 1224 of the interface or the accessories in liquids. 1225 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 38/49 Manual 1226 1227 25. General Inspection Every Use Visually check the condition of the all parts and the accessories before 1228 every use. Remove from service any unit and/or accessories that shows 1229 signs of physical damage. 1230 1231 1232 26. Service All service must be performed by Medimetrics or its authorized agents. 1233 For service, contact Medimetrics. 1234 1235 1236 1237 1238 1239 1240 1241 1242 1243 1244 1245 1246 1247 1248 1249 Medimetrics Philips Research High Tech Campus 34 (WB.2-043) 5656 AE Eindhoven The Netherlands Telephone:
+31 40 27 49268
-------------------------------------------
Medimetrics Philips Research 345 Scarborough Road Briarcliff Manor, NY 10510 Telephone:
+1 914 945 6628 27. Product Changes All products and product specifications are based upon information 1250 available at the time of publication. The right is reserved to discontinue 1251 any of these products or to change any such specifications without prior 1252 notice. 1253 1254 1255 28. Technical Information The IntelliCap System and its accessories are designed in accordance 1256 with the applicable harmonized international standards for medical 1257 1258 devices. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 39/49 Manual 1259 1260 1261 29. Label 29.1 Capsule Note: The IntelliCap serial number is formed by two numbers: the one 1262 on the electronic body (white part in the Figure 9) + the one on the 1263 medicine reservoir ring (black part in the Figure 9). 1264 1265 1266 1267 1268 1269 1270 1271 1272 1273 1274 1275 1276 1277 1278 1279 1280 1281 1282 1283 1284 1285 1286 1287 1288 1289 1290 1291 1292 1293 1294 1295 Figure 9: Laser engraving of the IntelliCap capsule Laser engraving electronic body:
where Medimetrics INTELLICAP iPSYYMXXXW YY indicates the year (i.e. 00, , 99) M indicates the month (i.e. 1, 2, , 9, A, B, C) XXX indicates the serial number (i.e. 001, , 999) W indicates capsule type:
-
-
M test, PROTO, DEMO, mockup F fully functional capsule Laser engraving reservoir ring:
where Medimetrics INTELLICAP YYMXXXW YY indicates the year (i.e. 00, , 99) M indicates the month (i.e. 1, 2, , 9, A, B, C) XXX indicates the serial number (i.e. 001, , 999) W indicates capsule type:
-
-
M test, PROTO, DEMO, mockup F fully functional capsule Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 40/49 Manual 1296 1297 1298 1299 1300 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1317 29.2 Storage Vial Medimetrics Controlled release solutions IntelliCap Capsule Philips Electronics Nederland B.V. acting through Philips Research acting through Philips Medimetrics HTC 34 (WB.2-043) 5656 AE Eindhoven, The Netherlands iPSYYMXXXW YYMXXXW 0344 xx-xxxx FCC ID: xxxxxxxx Property of Medimetrics Note: The vial is labeled with the same number as indicated on the 1318 capsule electronic body (first number). The medicine ring number (second 1319 number in the serial number line) is represented by the second number. 1320 1321 1322 Note: The barcodes are optional and might not be present. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 41/49 Manual 1323 1324 1325 1326 1327 1328 1329 1330 1331 1332 1333 1334 1335 1336 1337 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 29.3 Portable Unit Medimetrics Controlled release solutions 0344 IntelliCap Portable Unit iPS-PU2k-xxx Philips Electronics Nederland B.V. acting through Philips Research acting through Philips Medimetrics High Tech Campus 34 (WB.2-043) 5656 AE Eindhoven, The Netherlands
+31 40 27 49268 The Netherlands
+1 914 945 6628 USA FCC ID: xxxxxxxx Return to Medimetrics after use The letter k in the label indicates the difference on operational 1352 frequency:
1353 1354 1355 k = V The module operates at 868MHz k = W The module operates at 2.4GHz Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 42/49 Manual 29.4 Control Center Unit 1356 1357 1358 1359 1360 1361 1362 1363 1364 1365 1366 1367 1368 1369 1370 1371 1372 1373 1374 1375 1376 1377 1378 0344 Medimetrics Controlled release solutions Control Center Unit P r i n t iPS-CCU-xx Philips Electronics Nederland B.V. acting through Philips Research acting through Philips Medimetrics High Tech Campus 34 (WB.2-043) 5656 AE Eindhoven, The Netherlands
+31 40 27 49268 The Netherlands
+1 914 945 6628 USA Property of Medimetrics Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 43/49 Manual 1379 1380 1381 1382 1383 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395 1396 1397 1398 1399 1400 1401 1402 1403 1404 1405 1406 29.5 Start-Up Unit 0344 Medimetrics Controlled Release Solutions Start Up Unit iPS-SSU-xx Philips Electronics Nederland B.V. acting through Philips Research acting through Philips Medimetrics High Tech Campus 34 (WB.2-043) 5656 AE Eindhoven, The Netherlands
+31 40 27 49268 The Netherlands
+1 914 945 6628 USA FCC ID: xxxxxxxx Property of Medimetrics Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 44/49 Manual 1407 29.6 Symbols 1408 Term Definition Consult Instructions for Use Do not Re-use Shock Protection Type = BF Not for General Waste Keep Dry Manufacturer Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 45/49 Manual Term Definition Serial Number Use By Federal Communications Commission Certification Notified Body Certified Medical Product 0344 1409 Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 46/49 Manual 1410 30. IntelliCap Capsule Specifications 1411 CATEGORY ITEM PROPERTY NOTE Size (mm) 11 x 26.7 Diameter x Length Weight of unloaded pill Physical
(g) 3.2 Nominal Specific density of loaded pill (g/cm^3) Between 1.5 1.6 1.5 Nominal, assuming medication at 1g/cm^3 Duration Up to 48 hour Depends on the program P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d Operational life Number of cycles
> 18000 Measure, transmit, and receive Medication capacity
(l) 275 Nominal Drug delivery Medication state suspension, or Liquid solution, emulsion Viscosity, maximum 1.0 Pa sec Minimum dispensing volume () 1.0 Profile specification User defined Discrete segments, executed sequentially Programmable Delivery Profile Dispense modes
(segments) 1) Burst release 1) Fastest dispense 2)Sustained release 2) Evenly distributed 3) No release 3) Measure and report Burst release duration <15 minutes Empty full reservoir pH accuracy calibrated 0.5 0.25 Absolute Resolution Sensors Temperature, range and accuracy IntelliCap to portable Communication unit 20-40 C, +/-1.0 C Temperature of outside environment (or better) Bi-directional 400-440 MHz MICS and ISM channels selectable at initialization Pill identification ID code assigned Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 47/49 Manual 1412 31. Portable Unit Specifications 1413 CATEGORY ITEM PROPERTY NOTE Size (mm) 117x79x24 Weight (g) 180 Nominal Nominal Physical Housing Plastic Enclosure Portability Power source Cable-less during normal operation Rechargeable battery Closed with no accessible switches or connectors. No operation by the test subject. Typical use is placement in a soft belt piece provided with the system Normal operation Battery lifetime
> 48 hours Full charged Power Charging source Indicator LEDs On/Off On/Off Optional IntelliCap to Portable Unit Control Center PC to Portable Unit Range Control Center PC to Communication Portable Unit Li-ion battery charger 1.3 A, 4.2 V output Switch located internal on the PCB Accessed by system operator. Torx driver required to open housing Green Continuous when on 2 additional LEDs Use not specified 400-440 MHz Bi-directional MICS and ISM via Amber module USB dongle at Control Center PC Up to 50m in open space Stand alone operation Wired communication All data packets are Data capture continues recorded in local when away from the control memory center area Optional USB connection for data download For after an experiment. Housing must be opened. Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 48/49 Manual 1414 32. Start Up Unit Specifications 1415 CATEGORY ITEM PROPERTY NOTE Physical Size (mm) Weight (g) 120x95x35 290 Nominal Nominal Housing Metal Enclosure Removable lid attached with screws Power Power source via USB cable Connector provided Power coupling via start-up coil Internally mounted RF frequency range 18.5 21.5 MHz, frequency sweep Nominal Pill Activation Capsule may remain Capsule interface Proximity to start up in the storage vial. coil ISFET window facing IntelliCap to Start Up Unit Control Center PC to Start Up Unit 400-440 MHz coil Bi-directional MICS and ISM USB cable Bi-directional Communication Service channel 401.25 MHz 1416 Used for activation reporting and initialization data exchange Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved P r i n t i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d 2010 Koninklijke Philips Electronics N.V. Philips Medimetrics IntelliCap User Manual page 49/49 Manual 1417 33. Document history Version Date Author Description of changes 0.1 2010-01-20 Jeff Shimizu First Draft - INCOMPLETE 0.2 2010-02-25 Jeff Shimizu Second Draft - INCOMPLETE 0.3 2010-04-09 Jeff Shimizu Draft Complete for review 0.4 2010-04-26 Ventzeslav Iordanov Reviewed version 1.0 2010-05-27 Jeff Shimizu Final (major) version CR N/A N/A N/A N/A N/A 1.1 2010-11-15 Ventzeslav Iordanov information added; new figures; new N/A Proposed new version
(label P r i n t 2.0 2010-11-22 Jeff Shimizu Final (major) version N/A structure) 1418 1419 END OF DOCUMENT. i e d c o p e s a r e u n c o n t r o l l e d l u n e s s a u t h e n t i c a t e d Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved
1 2 | manual2 | Users Manual | 7.01 KiB |
Regulatory Statement for FCC (FCC ID: YDVINTELLICAP-CI). FCC Information to User This product does not contain any user serviceable components and is to be used with approved antennas only. Any product changes or modifications will invalidate all applicable regulatory certifications and approvals FCC Guidelines for Human Exposure Pursuant to Part 2 of the FCC Rules, section 2.1093, this device is categorically excluded from routine environmental evaluation for RF exposure. FCC Electronic Emission Notices This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Radio Frequency Interference statement This equipment has been tested and found to comply with the limits for a class B device (all other receivers subject to Part 15), pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. Operation of this equipment in a residential area may cause harmful interference, in which case the user will be required to correct the interference at his own expense. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
. Reorient or relocate the receiving antenna
. Increase the separation between the equipment and receiver
. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
. Consult the dealer or an experienced radio/TV technician for help
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2012-06-22 | 433.2 ~ 434.6 | DSC - Part 15 Security/Remote Control Transmitter | Class II Permissive Change |
2 | 2011-09-05 | 433.2 ~ 434.6 | DSC - Part 15 Security/Remote Control Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2012-06-22
|
||||
1 2 |
2011-09-05
|
|||||
1 2 | Applicant's complete, legal business name |
Medimetrics Personalized Drug Delivery B.V.
|
||||
1 2 | FCC Registration Number (FRN) |
0019791185
|
||||
1 2 | Physical Address |
High Tech Campus 5 (HTC5.2-041)
|
||||
1 2 |
Eindhoven, N/A
|
|||||
1 2 |
Netherlands
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
c******@telefication.com
|
||||
1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
YDV
|
||||
1 2 | Equipment Product Code |
INTELLICAP-CI
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
V******** I******
|
||||
1 2 | Title |
Director Q&R, System Architect
|
||||
1 2 | Telephone Number |
+31 4********
|
||||
1 2 |
v******@medimetrics.com
|
|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
Medimetrics Personalized Drug Delivery B.V.
|
||||
1 2 |
Philips Research
|
|||||
1 2 | Name |
V**** I********
|
||||
1 2 | Physical Address |
Netherlands
|
||||
1 2 | Telephone Number |
+3140********
|
||||
1 2 |
v******@medimetrics.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/06/2012 | ||||
1 2 | 10/15/2011 | |||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DSC - Part 15 Security/Remote Control Transmitter | ||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | IntelliCap Capsule | ||||
1 2 | IntelliCap | |||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Class II Permissive Change | ||||
1 2 | Original Equipment | |||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Telefication B.V.
|
||||
1 2 | Name |
W**** J****
|
||||
1 2 | Telephone Number |
00318********
|
||||
1 2 | Fax Number |
31-31********
|
||||
1 2 |
w******@telefication.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15.231(e) | 433.20000000 | 434.60000000 | |||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15.231(e) | 433.20000000 | 434.60000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC