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Zalviso
(sufentanil sublingual tablet system) Instructions for Use AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 1 1. Table of Contents 1. 2. 3. 4. 5. 6. 7. 8. Table of Contents ............................................................................ 2 Explanation of Symbols................................................................... 5 Introduction and Product Features.................................................. 6 Intended System Use............................................................................................... 6 3.1. About the Sufentanil Sublingual Tablet System ........................................................ 6 3.2. Operating Features and Definitions .......................................................................... 7 3.3. 3.4. Warnings and Cautions.......................................................................................... 10 System Components .....................................................................12 Controller............................................................................................................... 15 4.1. Dispenser .............................................................................................................. 18 4.2. Cap........................................................................................................................ 18 4.3. Drug Cartridge ....................................................................................................... 19 4.4. Patient Identification (ID) Thumb Tag ..................................................................... 19 4.5. Authorized Access Card......................................................................................... 20 4.6. Holster ................................................................................................................... 21 4.7. Security Tether....................................................................................................... 22 4.8. 4.9. Cleaning Plug ........................................................................................................ 22 4.10. Charger and Data Cable ........................................................................................ 23 4.11. Cartridge Label RFID Reader................................................................................. 24 How to Set Up the System for a New Patient ...............................25 Patient Training .............................................................................44 Patient Use....................................................................................54 How to Take a Dose (Dose Available) .................................................................... 54 7.1. Understanding Dose not Available (Lockout Mode) ................................................ 57 7.2. Cleaning the System During Patient Use................................................................ 59 7.3. Storing the System During Patient Use................................................................... 60 7.4. Use of the System.................................................................................................. 60 7.5. Replacing the Patient ID Thumb Tag............................................61 AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 2 8.1. 8.2. If the Patient ID Thumb Tag is Loose...................................................................... 61 If the Patient ID Thumb Tag is Either Lost, Dropped, Defective or Becomes Non-
Functional.............................................................................................................. 61 Changing a Cartridge ....................................................................63 Tether Unlock ................................................................................66 Basic Dose History and Detailed History ......................................68 11.1. Basic Dose History................................................................................................. 68 11.2. Detailed History...................................................................................................... 71 Resetting Shift Total ......................................................................73 Cleaning During Patient Use.........................................................74 Discontinuation of Therapy, Disposition of Used Components and Accounting of Remaining Tablets .................................................75 14.1. Discontinuation of Therapy and Disposition of Used Components .......................... 75 14.2. Accounting of Remaining Tablets........................................................................... 79 Replacing the System ...................................................................82 Notifications, Alerts, Alarms and Errors ........................................83 16.1. Notifications ........................................................................................................... 83 16.2. Alerts and Errors.................................................................................................... 90 16.3. Alarm..................................................................................................................... 93 Reprocessing Instructions.............................................................95 17.1. Reprocessing of Reusable Components................................................................. 95 17.2. Reprocessing the Controller................................................................................... 99 17.3. Reprocessing the Controllers Cleaning Plug........................................................ 106 17.4. Reprocessing the Tether...................................................................................... 108 17.5. Reprocessing the Holster ..................................................................................... 110 Recharging the Controller ...........................................................112 Transferring Patient Use Data.....................................................115 Reviewing Former Patient Data ..................................................122 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 3 21. 22. Device Information Screen..........................................................125 Troubleshooting...........................................................................126 Patient Cannot Dose, but System Appears Normal............................................... 126 Patient Cannot Dose, System Appears Unresponsive .......................................... 127 22.1. 22.2. 22.3. Cartridge is not Recognized during Setup or Replacing Cartridge (Receive No 22.4. Cartridge Notification) ......................................................................................... 127 Authorized Access Card (AAC) or Technician Access Badge (TAB) is not Recognized by System......................................................................................... 127 22.5. During Change Cartridge or Initial Set Up, the Priming Cap is not observed as being ejected from the System....................................................................................... 128 System Does Not Power On................................................................................. 128 22.6. 22.7. System screen is on but System appears unresponsive ....................................... 128 22.8. Controller cannot be powered off when not in Patient Use .................................... 129 22.9. Dispenser cannot be removed after System is Discontinued................................. 129 22.10. Controller powers on then powers off ................................................................... 129 General Information.....................................................................130 23.1. System Information.............................................................................................. 130 23.2. Inspect Packaging and Components .................................................................... 137 23.3. Storage and Handling .......................................................................................... 137 Use of Cartridge Label RFID Reader..........................................138 Biomedical Technician Utility Menu ............................................141 25.1. Accessing the Technician Utility Menu.................................................................. 142 Diagnostics ..................................................................................144 26.1. Accessing the Diagnostics Screen........................................................................ 144 26.2. Diagnostic Test Descriptions................................................................................ 145 Power Down from Utility Menu....................................................153 Set Time and Date ......................................................................154 Use Life .......................................................................................156 23. 24. 25. 26. 27. 28. 29. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 4 2. Explanation of Symbols On the packaging and on the sufentanil sublingual tablet system (System) you may encounter the following symbols shown here with their meanings. Please consult instructions for use System contains a non-ionizing RF transmitter Do not reuse Keep away from MRI exposure and equipment Keep away from X-ray exposure and equipment Date of manufacture Manufacturers batch or lot code Class II equipment Type BF equipment Identifies switch to power on system System alert or alarm condition AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 5 3. Introduction and Product Features 3.1. Intended System Use The Zalviso sufentanil sublingual tablet system (also referred to as sufentanil sublingual tablet system or System) is for the management of moderate-to-severe acute pain in adult patients in a hospital setting. Important Safety Message! Due to the risk of accidental exposure and/or overdose, Zalviso must only be used in acute care inpatient hospitals. The device must never be dispensed for outpatient pain management or continued after the patient is discharged from the hospital. 3.2. About the Sufentanil Sublingual Tablet System The sufentanil sublingual tablet system is a handheld, battery-operated, patient-controlled analgesia (PCA) System that allows patients to administer tablets to manage post-operative pain during their in-hospital stay. The tablets contain 15 mcg of sufentanil, a potent opioid and a controlled substance, so the System functions as a dispensing device as well as an electronically controlled System for dosing an opioid. Additionally, patient dosing data is captured by the System and is reviewable by the Healthcare Professional during or after patient use. The maximum amount of time permitted by a single System for patient use is 72 hours. If additional therapy is required past 72 hours, a new System has to be set up for the patient. Refer to Section 15, Replacing the System, and Section 16, Notifications, Alerts, Alarms and Errors, for details on the Systems 72 hour limit. The Healthcare Professional should set up the System for each new patient. The setup process includes:
Installing a new Cartridge into the Dispenser Powering on the System Attaching the Dispenser to the Controller Priming the System Attaching the Patient ID Thumb Tag to the patients thumbnail Attaching the Security Tether to a stationary object and then to the bottom of the Controller Training the patient on how to take a dose and when the dose is in lockout (unavailable) through the Patient Training Screens and demonstration Provide the patient with the Patient Reference Sheet to supplement patient training Storing the System in the Holster which is attached to the patients bedrail AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 6 Following the initial setup and during patient use, the Healthcare Professional may need to perform additional tasks such as:
Replacing the Patient ID Thumb Tag Changing a Cartridge (up to 3 Cartridges can be used in 72 hours) Cleaning the System Reviewing the Basic Dose History and Detailed History Unlocking the Tether to adjust the Location of the System Resetting the Shift Total Addressing Alarms, Alerts and Notifications Replacing the System After patient use:
The System should be discontinued and components handled according to instructions provided in subsequent sections of this document. 3.3. Operating Features and Definitions The following are important System features and definitions. Lockout The time period when the System is not available for dosing by the patient. This period has been factory programmed to 20 minutes. The patient will not be able to dose until 20 minutes have elapsed since the last dose. Refer to Section 7, Patient Use, for more information regarding lockout. Authorized Access Card (AAC) or Access Card The System requires the Healthcare Professional to present an AAC to access the System. The AAC is a Radio Frequency Identification (RFID)-embedded card that communicates with the System and may be stored in a medication inventory management system or according to Institution procedures. Refer to Section 4, System Components, for more information on the AAC. Adhesive Thumb Tag with RFID (Patient ID Thumb Tag) The patient requires a Patient ID Thumb Tag (also referred to as Thumb Tag) to access the System and dose themselves with medication. This Thumb Tag is an RFID-embedded adhesive band that communicates with the System and is secured to the patients thumb during initiation of therapy. The Patient ID Thumb Tag must be placed on the thumb that the patient will use for pressing the dose button. Refer to Sections 4, 5, 6, 7 and 8 for more information on the Patient ID Thumb Tag. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 7 Priming Cap Each Cartridge contains a green plastic Priming Cap that must be ejected
(primed) from the Cartridge through the System before a patient can use the System. This action enables diagnostics within the System to ensure that it is performing normally before patient use. Refer to Section 5, How to Set Up the System for a New Patient, for more information on the Priming Cap. The System will recognize the Drug Cartridge contents and display:
Drug name Dosage strength Number of tablets present Patient Training Screens (Section 6) During new patient setup, the System displays a brief set of training screens that provide cues to the Healthcare Professional to train the patient on certain features of the System. This includes an interactive demonstration of the Green Dose Available and Blue No Dose Available (System in lockout) indicator lights. These screens also allow the demonstration of the flashing green light indicator within the dose button when the patient places the thumb with the Patient ID Thumb Tag near it, as well as the tones that the System provides as feedback to the patient if dosing was successful or not. The screens also provide the Healthcare Professional cues to train the patient to remove the Cap before dosing, to hold the System upright during dosing, and to place the System in the Holster after use. Refer to Section 7, Patient Use, for more information. Discontinuing Therapy After the patient is done receiving their therapy, the System is discontinued according to instructions in Section 14, Discontinuation of Therapy and Disposition of Used Components. Cartridge Access and Changing During patient use, the Cartridge containing the medication is locked in the System. When medication is running low, the System will issue notifications through light indicators and tones. The Healthcare Professional can access the System with the AAC and select options for replacing the Cartridge. Refer to Section 9, Changing a Cartridge, for more information on changing the Cartridge. Dispenser Removal During patient use, there may be a need to remove the Dispenser and replace it with a new one. To do this, the Healthcare Professional can access the System with the AAC and select the option for replacing the Cartridge (see Section 9, Changing a Cartridge). Replacing the Dispenser must be accompanied by replacing the Cartridge with a new Cartridge. If the same Cartridge is used with the new Dispenser, the System will alert the Healthcare Professional that a used Cartridge is detected. This will cue the Healthcare Professional to retrieve a new Cartridge for patient use. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 8 Replacing a Patient ID Thumb Tag If the Patient ID Thumb Tag either ceases to operate or becomes lost or otherwise rendered unusable, the Healthcare Professional can access the System with the AAC and select the option to replace Thumb Tag. Refer to Section 8, Replacing the Patient ID Thumb Tag, for more information. Resetting Shift Total The Healthcare Professional can reset the Shift Total by accessing the System with the AAC and selecting the option for Shift Reset. Refer to Section 12, Resetting Shift Total, for more information on the Shift Total reset function. Removing the Security Tether If the System needs to be moved from the patients bedside, it needs to be un-tethered and then re-tethered securely to an object (e.g., chair, wheelchair, gurney, walker). To do this, the Healthcare Professional can access the System with the AAC and select the option for Tether Unlock. Refer to Section 10, Tether Unlock, for more information on securing the Tether. Reviewing current patient detailed use history The detailed history contains the event log of the current patients System which can be accessed by the Healthcare Professional by accessing the System with the AAC and selecting Detailed History from the menu. This history will provide a chronological sequence of all events that occurred within the System since initiation of therapy. Refer to Section 11, Basic Dose History and Detailed History, for more information on the detailed history. Silencing Alerts/Alarms Alerts may be temporarily silenced by the Healthcare Professional. Alarms may only be silenced by Discontinuing the System. Refer to Section 16, Notifications, Alerts, Alarms and Errors, for more information on how to silence an Alert and address Alarms and Errors. Biomedical Technician Utility features When the System is not in patient use, the System Controller has biomedical technician utility features accessible by the biomedical technician when a Technician Access Badge (TAB) is presented to the Controller. The TAB is a Radio Frequency Identification (RFID)-embedded card that communicates with the System Controller and may be stored in Biomedical or according to Institution procedures. Refer to Section 25, Biomedical Technician Utility Menu, for more information on the biomedical technician utility features. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 9 3.4. Warnings and Cautions Warning: Operation is Limited to Trained Operators The sufentanil sublingual tablet system operation is strictly limited to patients and Healthcare Professionals trained in the use of the System. Warning: Disposal When discarding disposable sufentanil sublingual tablet system components, adhere to local, state, federal and/or other governing regulation. Warning: System components are not serviceable. Tampering with, modification to, or opening of the System or its components may lead to hazardous conditions and will void manufacturers warranty. Warning: Increased electromagnetic emissions or decrease electromagnetic immunity. Warning: Proximity to portable RF communications equipment Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the sufentanil sublingual tablet system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Caution: Be Cautious Near MRI and X-ray Equipment Keep the sufentanil sublingual tablet system away from MRI and X-ray equipment. Caution: Be Cautious of Electrostatic Discharge To avoid electrostatic discharge, do not use the System in a very dry environment, especially one in which synthetic materials are present. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 10 Caution: Be Cautious of Condensation Sudden changes in temperatures can cause condensation to form in or on the Controller. If this has occurred, do not turn on the Controller. Allow the Controller to return slowly to room temperature. Never keep the Controller or System in a room that is likely to harbor condensation (e.g. a bathroom). Caution: Do Not Improperly Clean System Only follow cleaning procedures stated in Section 13, Cleaning During Patient Use, and Section 17, Reprocessing Instructions, in this manual. Use only specified cleaning agents. Caution: Do Not Disassemble Controller There are no serviceable parts. Do not tamper with or open the System Controllers case. Caution: Never Immerse the Controller in Water or Other Liquids Caution: Never Autoclave The System is not waterproof. Never sterilize the Controller in a steam autoclave or gas sterilizer. Using autoclave or gas sterilization can seriously damage the Controller and void the warranty. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 11 4. System Components The sufentanil sublingual tablet system is comprised of the following components as shown below. Refer to the following sections for details of each component. Controller
(Section 4.1) Dispenser
(Section 4.2) Cap
(Section 4.3) Drug Cartridge Patient ID Thumb Tag
(Section 4.4)
(Section 4.5) Authorized Access Card (AAC)
(Section 4.6) Holster
(Section 4.7) Security Tether
(Section 4.8) Cleaning Plug
(Section 4.9) AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 12 Charger
(Section 4.10) Data Cable
(Section 4.10) Technician Access Badge
(Section 25) Cartridge Label RFID Reader
(Section 4.11) The following System components are re-usable:
1. Controller 2. Holster 3. Security Tether 4. Authorized Access Card 5. Technician Access Badge 6. Charger 7. Data Cable 8. Cleaning Plug AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 13 The following System components are for single-patient use and disposable:
1. Dispenser and Cap 2. Drug Cartridge 3. Patient ID Thumb Tag The following component is provided as an optional accessory for use in the hospital pharmacy
(following patient use) and is re-usable:
1. Cartridge Label RFID Reader AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 14 4.1. Controller The reusable Controller contains the rechargeable battery, drive mechanism for the System, and all the electronic control elements needed to track and control dosing of the tablets. Front View of Controller The Controller is locked to the Dispenser and Tether while in use. The Controller should be appropriately cleaned and reprocessed according to the instructions in Section 17, Reprocessing Instructions. The front side of the Controller, comprising five buttons and the display screen that the Healthcare Professional will interact with while setting up and using the System, is shown below:
AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 15 Power Button - Press and hold the Power Button for a few seconds until the Controller turns on. If the Controller is powered on and not setup for patient use, press and hold the Power Button for a few seconds to power off the Controller. During power down, a power down audible tone is generated followed by the display and indicators turning off. If the System is in use, the power button alone cannot be used to power off the System. Turning the System off is accomplished by accessing the System Menu and selecting Discontinue. Follow the displayed instructions to Discontinue and power off the System. Display Screen - The Controller screen will display the current status (e.g., Dose Available, Dose Not Available and number of tablets remaining) and allow a Healthcare Professional access to the System Menu. The display has a screen timeout if there is no activity after 30 seconds. Press the Enter/Select or Menu button to wake up the Systems screen and resume viewing the screen content. Left/Right Buttons - Use the Left and Right Buttons, located below the display screen, to scroll through screen content as indicated on the screen. Enter/Select Button - This is the blue circular button located in the center below the Left/Right Buttons. Use this button to select an item in the Menu. This button can also be used to access the basic dosing history that is available at any time during patient use, which does not require the Authorized Access Card. Pressing the Enter/Select button will also wake up the Systems screen. Menu Button - Press this button to access the System Menu. You will be prompted to scan your Authorized Access Card in order to access this menu. Pressing the Menu button will also wake up the Systems screen. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 16 The back of the Controller has three main features that the patient will use on a regular basis:
Back View of Controller with Dose Button and Dose Indicators No Dose Available Indicator (Upper Left Side) - A blue light will illuminate above the lock icon to indicate that the System is in lockout and a patient cannot receive a dose. Dose Available Indicator (Upper Right Side) - A green light will illuminate above the unlock icon to indicate that a dose is available for the patient. Blue Dose Button (Center) - Healthcare Professionals will touch the Authorized Access Card to this area to access the Menu and activate functions of the System. Patients will touch their Patient ID Thumb Tag on the Blue Dose Button when the System is available for dosing. This causes the green light indicator within the Dose Button to flash indicating to the patient that the System is ready to dose and will dispense a tablet if the button is pressed. Upon actuation of the Dose Button, a tablet is dispensed to the patient. Refer to the New Patient Setup instructions in Section 5, How to Set Up the System for a New Patient, for more details on using the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 17 4.2. Dispenser The single-use Dispenser has a specially designed tip to facilitate the sublingual placement of tablets. The Cartridge is placed inside the Dispenser and then the Dispenser is attached to the Controller. The patient should always place the Dispenser tip under their tongue when dispensing a tablet. The Dispenser should be cleaned as needed during patient use. Refer to instructions in Section 7, Patient Use. The Dispenser should be disposed of at the end of a patients use according to institutional procedures for Biohazards. Never re-use a Dispenser for another patient. Refer to Section 5, How to Set Up the System for a New Patient, for more details on assembling the Cartridge, Dispenser, and Controller. 4.3. Cap The Cap protects and covers the tip of the Dispenser and should always be placed over the tip when the System is not being used by the patient for dosing. Additionally, the Healthcare Professional should ensure the Cap is in place during setup and other Healthcare Professional handling of the System. The Cap may be cleaned during patient use. Refer to instructions in Section 7, Patient Use. The Cap should be disposed of at the discontinuation of therapy according to institutional procedures for Biohazards. Never re-use the Cap for another patient. Refer to Section 5, How to Set Up the System for a New Patient, for more details on using the Cap. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 18 4.4. Drug Cartridge Each new Cartridge is intended for single-patient use and contains forty 15 mcg tablets and 1 green plastic Priming Cap. The Cartridge has a white tab and green plastic tail that need to be removed before the Cartridge is inserted into the Dispenser. The green Priming Cap will be ejected by the System during the setup process. Never attempt to re-use a Cartridge, either for the same patient or another patient (the System will not allow it). Never re-use remaining tablets from a used Cartridge for another patient. Always dispose of used Cartridges according to institutional procedures pertaining to Controlled Substance opioids. Refer to Section 5, How to Set Up the System for a New Patient, for more details on preparing a new Cartridge, inserting the Cartridge into the Dispenser, and priming the System. 4.5. Patient Identification (ID) Thumb Tag The Patient ID Thumb Tag allows secure access by the patient to the System. The Patient ID Thumb Tag contains Radio Frequency Identification (RFID) and acts as a single-patient identification key to limit the use of the System to only the patient. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 19 About the Patient ID Thumb Tag:
Must be worn by the patient as it is needed to identify the patient to the System to permit dosing. Should only be placed on the patients thumb and the center of the Patient ID Thumb Tag should be placed over the thumbnail. Should be placed onto the patients thumb on the hand that is most accessible for System use. Should not be exposed to X-rays, MRIs, or other strong electromagnetic fields. Should be disposed of at the discontinuation of therapy according to institutional procedures. Refer to Section 5, How to Set Up the System for a New Patient, for more details on attaching the Patient ID Thumb Tag and Section 8, Replacing the Patient ID Thumb Tag, for replacing or re-
attaching the Patient ID Thumb Tag. 4.6. Authorized Access Card The Authorized Access Card (AAC) allows the Healthcare Professional access to set up and manage the System. The Healthcare Professional will use this card to gain access to the System to operate and manage it. The System prompts the Healthcare Professional to touch the blue circle of the AAC to the Blue Dose Button located on the back of the Controller. The AAC should not be exposed to X-rays, MRI, or other strong electromagnetic fields. Refer to the New Patient Setup instructions in Section 5, How to Set Up the System for a New Patient, for more details on when and how to use the Authorized Access Card. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 20 4.7. Holster A Holster is provided for the System to be stored in when it is not in use by the patient. The Holster is composed of a holder and a clamp. Rotate the knob on the clamp to tighten or loosen the holder to the patients bedrail. The clamp can be rotated to assist with positioning. The Holster should be clamped to the patients bedside within easy access to the patients hand with the Patient ID Thumb Tag. Refer to Section 5, How to Set Up the System for a New Patient. When patient is not in bed and the System is moved with the patient, the Holster should be attached to an object near the patient (e.g., chair, table, walker, wheelchair or gurney) so that the System is within easy reach. The Holster should always be used to prevent inadvertent dispensing of tablets by the patient when not dosing. The Holster should be appropriately cleaned and reprocessed according to the instructions in Section 17, Reprocessing Instructions. Refer to the New Patient Setup instructions in Section 5, How to Set Up the System for a New Patient, for more details on attaching the Holster. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 21 4.8. Security Tether The reusable Tether is a cable assembly that will secure the System to the patients bedside to prevent theft. One end should be attached (by creating a secure loop) to the patients bedrail (as illustrated above) and the other end should then be placed into the bottom of the Controller. When patient is not in bed, the Tether should be attached securely to an object near the patient
(e.g., chair, wheelchair, walker or gurney). The Tether should be reprocessed. Refer to the New Patient Setup instructions in Section 5, How to Set Up the System for a New Patient, for more details on securing the Tether. Also refer to instructions in Section 17, Reprocessing Instructions. 4.9. Cleaning Plug The reusable Cleaning Plug is provided to cover the Controllers Charging/Data connector when the Controller is reprocessed. Refer to Section 17, Reprocessing Instructions, where the Cleaning Plug is utilized during reprocessing of the Controller then the Cleaning Plug is reprocessed after use. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 22 4.10. Charger and Data Cable A Charger is provided to charge the Controller. The Controller must be charged for at least 8 hours or until the Charging Complete message is displayed on the screen. While the Controller is being charged the blue No Dose Available Light flashes to indicate status and the Battery Charging message is displayed on the screen. At the completion of charging, the blue light stops flashing and the display screen shows a Charging Completed message. Refer to Section 18, Recharging the Controller, for more details about charging the Controller. Warning: Use only the Charger specified for the Controller. Use of any other power supply adapter may damage the Controller or cause personal injury. WARNING A Data Cable is provided to transfer Patient Use data from the Controller to a computer. Refer to Section 19, Transferring Patient Use Data, for details. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 23 4.11. Cartridge Label RFID Reader A Cartridge Label RFID Reader is available for use in the hospital pharmacy to assist with the auditing of used Drug Cartridges. The Reader enables the user to read the Cartridge RFID Label which indicates the remaining tablet count recorded by the System when the Cartridge was removed from the System. Refer to Section 24, Use of Cartridge Label RFID Reader, for details on use of the Cartridge Label RFID Reader. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 24 5. How to Set Up the System for a New Patient To set up the sufentanil sublingual tablet system for a new patient, please follow the steps below:
STEP 1 Gather Components Inspect individual packages for damage. 1. Obtain the components listed below. 2. 3. DO NOT remove Cartridges from pouches until ready for use. 4. Make sure the components are all new or cleaned according to the recommended procedure. Controller Authorized Access Card (AAC) Dispenser with Cap and Patient ID Thumb Tag and Patient Reference Sheet Dispenser Kit Contains:
AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 25 Patient ID Thumb Tag Zalviso Pouched Drug Cartridge Security Tether Holster Once all the components have been gathered, unpack all the components from their packaging and inspect for any damage. If damage is noted, replace with a newly inspected component. If setting up more than one System at the same time, avoid set up of the Systems in close proximity (i.e. within 4 to 5 feet) to each other. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 26 STEP 2 Prepare Device Remove the Controller from its storage bag. Remove the Dispenser with Cap and Patient ID Thumb Tag from its box and individual packaging. Ensure that the Cap stays on the Dispenser tip during handling. Do not touch the tip of the Dispenser during handling to avoid contamination. Remove the Dispenser with Cap and Patient ID Thumb Tag from the Dispenser Kit and individual packaging. Ensure that the Cap stays on the Dispenser tip during handling. Do not touch the tip of the Dispenser during handling to avoid contamination. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 27 STEP 3 Power-On Device Turn on the Controller by pressing and holding the Power button for approximately 3 to 5 seconds until the System turns on. The AcelRx screen will appear (see screen display below) and walk you through the setup process. Ensure that the Controllers battery is fully charged. If the Controller generates 3 audible beeps and then powers off, this indicates the Controller has failed the Power-On Self-Test, and should not be used. Return the Controller to Biomedical Engineering to perform diagnostics. During System use, if the System doesnt receive any inputs (button presses or movement), the screen will turn off after 30 seconds. To wake the screen, press the Enter/Select Button or the Menu Button. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 28 STEP 4 Touch Authorized Access Card The screen will prompt you to touch the blue circle of the Authorized Access Card to the Blue Dose Button on the BACK of the Controller. The System will announce a tone to confirm that the System has successfully read the card. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 29 STEP 5 Select Setup for New Patient Function The System Menu will be displayed on the Controller screen on the front of the Controller. Select the Setup for New Patient function by pressing the Enter/Select Button. Patient is not highlighted then use the Left/Right buttons to scroll to this function. If Setup for New AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 30 STEP 6 Prepare Drug Cartridge Obtain a new Drug Cartridge and prepare it for use as prompted by the screens. Remove the Drug Cartridge from its pouch. NOTE: Only a new Drug Cartridge can be used or the System will display an error or notification. Do not remove Cartridge from the pouch until you are ready to use. Grasp the white tab and pull up and away from the clear Cartridge body. DO NOT GRASP THE GREEN TAIL. Pull the white tab attached to the green plastic tail (do not twist), ensuring that the entire white tab and green tail are disconnected and removed from the Cartridge as shown below. This will leave a small green Priming Cap inside the top of the Cartridge that will be ejected by the System before patient use. The white tab and tail can be discarded. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 31 Confirm this step on the Screen by pressing the Enter/Select Button. STEP 7 Insert Cartridge Insert the Cartridge into the bottom of the Dispenser (green arrow on Cartridge label points up). Confirm this step on the screen by pressing the Enter/Select Button on the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 32 STEP 8 Connect Dispenser Snap the Dispenser (with Cartridge attached) onto the Controller. Did you receive a No Cartridge or Used Cartridge notification message?
INFO If you received a No Cartridge message, the System was assembled without a Cartridge. If you received a Used Cartridge message, the Cartridge that was inserted was either previously used or may have been tampered with. Refer to Section 16, Notifications, Alerts, Alarms and Errors, for further guidance on these notifications. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 33 STEP 9 Remove Cap Remove the gray protective Cap from the Dispenser. STEP 10 Eject Priming Cap Orient the System so that it is upright, and hold your hand directly below the Dispenser tip then press the Enter/Select Button to eject the green Priming Cap. Note: Priming Cap is very small so attempt to dispense into your hand. The System will then eject the Priming Cap out of the Dispenser. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 34 Select YES if you saw the green Priming Cap eject. If you did not see the green Priming Cap eject, examine the Dispenser Tip and the surrounding area. If you find the green Priming Cap in the Dispenser Tip remove it and select YES. If you find it in the surrounding area select YES. Select NO (Right Button) if the green Priming Cap failed to eject and then follow the screen instructions to exit setup and discontinue the System. The next screen Prime Failed Screen, as shown below, will instruct you to discontinue the System. Start over with a new Controller, Dispenser and Cartridge. The Priming Cap is not for patient use and should be discarded. WARNING Did you hear a negative tone and receive the Dispenser loose, press down message?
When the Dispenser loose, press down screen is displayed, the System has detected the Dispenser may not be fully seated in the Controller. Press down on the Dispenser. Confirm the Dispenser is fully seated in the Controller then press the Enter/Select Button to retry ejecting the Priming Cap. A total of 3 attempts to eject the Priming Cap is allowed. After the 3rd attempt, the System will proceed with a prime failure and the Error - System Cannot Be Used screen will be displayed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 35
| 1 | Manual 2/4 | Users Manual | 4.81 MiB |
If you confirm the Error - System Cannot Be Used, follow instructions on the next screen to discontinue the System (see Discontinuation of Therapy, Section 14) and start over with a new Controller, Dispenser and Cartridge. Did you receive the Prime Failed error message?
If any error occurs at this point, follow the on-screen instructions and discontinue the System (see Discontinuation of Therapy, Section 14) and start over with a new Controller, Dispenser and Cartridge. If you confirm the prime failure, follow instructions on the next screen to discontinue the System and start over with a new Controller, Dispenser and Cartridge. Refer to Section 16, Notifications, Alerts, Alarms and Errors, for further guidance on these notifications. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 36 STEP 11 Re-Cap The System Place the Cap back on the Dispenser before continuing. STEP 12 Scan Patient ID Thumb Tag Scan the new Patient ID Thumb Tag by touching it to Blue Dose Button on the back side of the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 37 Did you receive the Wrong Scan or Invalid Thumb Tag Detected notification message?
If one of these notifications occurs at this point, the Patient ID Thumb Tag scanned is defective or cannot be used by the System. Obtain a new Patient ID Thumb Tag then press the Enter/Select button and follow the on-screen instructions to scan the new Patient ID Thumb Tag. Refer to Section 16, Notifications, Alerts, Alarms and Errors, for further guidance on these notifications. When the Patient ID Thumb Tag is successfully scanned, you will hear an audible confirmation tone, and the System will transition to the next screen. NOTE STEP 13 Attach Patient ID Thumb Tag In preparation for the application of the Patient ID Thumb Tag, you may clean the thumb and nail with alcohol wipes and allow to dry. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 38 Attach the Patient ID Thumb Tag to the patients thumb. Make sure the center of the Patient ID Thumb Tag is over the patients thumbnail. Wrap the Thumb Tag around the thumb making sure both ends of the Thumb Tag are adhered to the thumb and not to the Patient ID Thumb Tag itself. Confirm the Patient ID Thumb Tag is on the patient by pressing the Enter/Select Button on the front of the Controller. If the Patient ID Thumb Tag is dropped or is damaged while applying it onto the patients thumb, discard it and continue to complete the setup of the System for the patient. After setup is complete, obtain a new Patient ID Thumb Tag then follow the instructions in Section 8, Replacing the Patient ID Thumb Tag. Attach the System Holster with its clamp to the patients bedrail (recommended) or any other secure object near the patient such that the System is easily accessible to the patient. STEP 14 Attach Holster Example Holster Mounting Position 1 AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 39 Example Holster Mounting Position 2 Attach the Security Tether securely to the patients bedrail. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 40 WARNING DO NOT attempt to add an extension to the supplied Tether as this may result in an unsecured System or may present a strangulation hazard. Additionally, proper use of the Tether requires passing it through the end loop as shown above. Do not attempt to tie the Tether or use the end loop as a means to loop it over an object; this may result in an unsecure System. DO NOT attach the Tether to the patient. Ensure that the Tether does not get tangled with any equipment lines that may be near the patient, since this could interfere with patient access to therapy. STEP 15 Attach Tether Attach the other end of the Tether to the System as shown on the screen; push the end of the Tether into the Controller until it stops (a magnet will assist with pulling the Tether into the System). The System will sense the Tether and automatically move to the next sequence in the setup. DO NOT place anything other than the Tether into the Tether port. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 41 STEP 16 Proceed to Patient Training Screens After the initial setup, the System will ask if you want to view the Patient Training Screens. These are a brief set of screens that provide cues to the Healthcare Professional to train the patient on certain System features. It is recommended that the Healthcare Professional always educate and train patients on the content of these screens before leaving them with the System to use on their own. These screens are accessible anytime during patient use as well, by using the AAC to access the menu. NOTE: No tablets will be dispensed during the Patient Training Screens demonstration. There will be a flashing DEMO indicator in the top right hand corner of the screen throughout the use of the screens to indicate that the System is not in Patient mode. The topics covered in these Training Screens include:
Place the Cap on the System and store the System in the Holster during use How to identify when a dose is available Removing the protective Cap before dosing Holding the System upright during dosing Placing the Dispenser tip under their tongue An interactive demonstration of the green Dose Available and blue No Dose Available indicator lights. It also demonstrates the flashing green light indicator within the Blue Dose Button when the patient places the thumb with the Patient ID Thumb Tag near it, as well as the tones that the System provides as feedback to the patient if dosing was successful or not. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 42 Not chewing or swallowing the tablet. Not eating or drinking for 10 minutes after dosing. Minimize talking for 10 minutes. How to identify when a dose is not available Call the nurse if the System is continuously beeping and flashing during use Provide the patient with the Patient Reference Sheet to supplement patient training Select YES (Right Button) to continue onto the next screen to review the Patient Training Screens. Select NO (Left Button) to skip these screens and continue to the next screen which instructs to provide the patient with the Patient Reference Sheet (Refer to Attachment 1). If NO is selected, this screen will appear. Educate the patient to refer to the Patient Reference Sheet for basic information on how to use the System. Refer to Section 7, Patient Use for further instructions on patient use. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 43 6. Patient Training Patient Training Screens The following screens are cues for the Healthcare Professional to train the patient on proper System use. The screens are not intended to be shown to the patient; rather they are prompts to the Healthcare Professional to demonstrate System features and train the patient. Some of the screens enable lights or tone demonstrations, as described below. No tablets will be dispensed during the Patient Training Screens demonstration. There will be a flashing DEMO indicator in the top right hand corner of the screen throughout the use of the screens to indicate that the System is not in Patient mode. NOTE In demonstration mode, if the System is left inactive for more than 30 seconds, it will go into sleep mode. To return to demo mode, use the AAC to access MENU and return to Demo Mode. NOTE Use the Left and Right Buttons to navigate between the screens. You can repeat any Patient Training Screen as needed by pressing the Left Button. The Patient Training Screens are also accessible through the System Menu any time after the initial setup as needed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 44 Patient Training Screens STEP 1 Cap and Store System Remind the patient to place the Cap on the System after dosing and store the System in the Holster when not in use. When the patient is ready to use the System, remove the System from the Holster. It is important to remind the patient to store the System in the Holster when not in use to minimize the chance of inadvertently dispensing a tablet by accidently pressing the Dose Button. If this occurs, the patient should call the Healthcare Professional to ensure the loose tablet is found and disposed of properly. NOTE STEP 2 Check Dose Availability Train the patient that the green Dose Available Light will illuminate when a dose is available and stay illuminated until a dose is taken. Show the patient the green light, located above the unlock icon. Inform the patient that this light indicates the System is available for the patient to take a dose. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 45 STEP 3 Thumb Tag Required to Dose Train the patient that only the thumb with the Patient ID Thumb Tag can be used to press on the Blue Dose Button to receive a dose of medication. STEP 4 Remove Cap Before Dosing The patient should be reminded that they must remove the Cap before dosing, otherwise the tablet will be dispensed into the Cap and the patient will not receive their dose. Should this occur accidently, the patient should call the Healthcare Professional to retrieve and properly dispose of the loose tablet in the Cap. The patient should request a new Cap if it is dropped or contaminated. STEP 5 Keep System Upright The patient should be instructed to KEEP THE SYSTEM UPRIGHT when dosing. Note: System will still permit dosing if it not perfectly upright. However, the System will not permit dosing in extreme orientations
(for example inverted), as the tablet may not be delivered to patient
. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 46 STEP 6 Place Dispenser Tip Under Tongue The patient should be reminded to first place the Dispenser Tip UNDER their tongue and THEN press the Blue Dose Button with their thumb. Do not apply downward pressure on the Dispenser tip when dosing. STEP 7 Do Not Touch Dose Button Until the Dispenser tip is under the Tongue The patient should be reminded not to touch or press the Blue Dose Button with their thumb until the dispenser tip is under the tongue. STEP 8 Do Not Pull Down When Dosing The patient should be reminded not to pull down on the dispenser tip when in the mouth when dosing. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 47 STEP 9 Simulate Dosing This demonstration can be repeated multiple times as needed, the System will not dispense any tablets during this demonstration. The patient should be reminded not to press the button until the Dispenser tip is under their tongue, and they should only remove it after they hear the dose confirmation tone, which will be heard after pressing the Blue Dose Button, and feel the motor vibration stop. Have the patient press the Blue Dose Button to simulate receiving a dose so the patient can hear the tone that the System produces to confirm the dose was dispensed. Have the patient place the System in their mouth and under their tongue and press the Blue Dose Button to get a feel for dosing. Tell the patient that the System will not dispense any tablets during this demonstration. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 48 STEP 10 Do Not Chew or Swallow the Tablet, Do Not Eat or Drink for 10 min. Educate the patient that the tablet should not be chewed or swallowed, and to not eat or drink for 10 minutes after dosing. Minimize talking for 10 minutes. STEP 11 Call a nurse if you drop or find a tablet The patient should be reminded to call the nurse if they drop a tablet when dosing or if they find a tablet. STEP 12 Simulate Dose Lockout Train the patient on what the System will do when in lockout and they cannot dispense a dose. The No Dose Available Light will be illuminated (blue) above the lock icon on the left side of the System. Train the patient that while the Dose Button can be pressed, a dose will not be dispensed. This demonstration can be repeated multiple times as needed. Educate the patient that the blue light indicates when a dose is not AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 49 available. Have the patient press the Blue Dose Button on the back of the Controller to hear the no dose tone that the System produces to communicate that the patient cannot receive a dose and the System is in lockout. STEP 13 Call Nurse Remind the patient to call the nurse when the System is continuously beeping and flashing between doses. The System will continuously beep and flash indicators when this screen is shown. STEP 14 Patient Reference Sheet Provide the patient with the Patient Reference Sheet to supplement patient training. Educate the patient to refer to the Patient Reference Sheet for basic information on how to use the System. Please refer to Attachment 1. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 50 STEP 15 Confirm Patient Training Complete After completion of the demonstration with the patient, the System will confirm that the patient training is complete on the screen with a message Training Complete Press OK to continue. Press the Enter/Select Button. STEP 16 Confirm Setup The System will confirm that the setup is complete on the screen with a message System Ready - Press OK and give to patient. Press the Enter/Select Button. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 51 STEP 17 Dose Available You will then see a green screen with the message Dose Available, with the drug name, dosage strength and number of tablets remaining. Hand the System to the patient and guide them through the process of taking their first dose. You should watch the patient take their first dose to ensure they understand proper System use. STEP 18 Provide Additional Verbal Instructions to the Patient 1. Use the System as needed for pain relief. 2. The System is only for the patient to use, not family or friends. 3. The System screen information is for the Healthcare Professional and should not be used 4. by the patient to determine when to dose. In the event that the System appears to be damaged, the patient should notify the Healthcare Professional. The Healthcare Professional should replace the damaged System with a new System as required. 5. The System should not be submerged in liquid, taken into shower, or placed in sink. For instructions on cleaning the System during patient use, see Section 7, Patient Use. WARNING The patient should only dose with a single tablet at the time it is dispensed by the System. The patient should never dispense tablets into their hands and take multiple tablets at a later time as this may cause serious injury or death. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 52 STEP 19 Store System Before leaving the patients room, make sure the System is stored back in the Holster within easy reach for the patient. The System should always be stored in the Holster when not in use by the patient or the Healthcare Professional. Discontinuation Once the patient is finished using the System and has completed their therapy, you will need to Discontinue the System and handle used components according to Section 14, Discontinuation of Therapy and Disposition of Used Components. NOTE System Messages Refer to Section 7, Patient Use, for a review of tasks and System messages to be dealt with during the 72-hour use period (or Patient Use). AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 53 7. Patient Use While the patient is using the System the following situations and screens may be encountered:
7.1. How to Take a Dose (Dose Available) The System has two ways to communicate that a dose is available:
Dose Available Light Dose Available Display A green light will be visible on the back side of the Controller (see example above). If the Enter/Select Button is pressed to wake up the screen, the front side of the Controller will display a green screen with the message Dose Available and list the drug name, dosage strength and number of tablets remaining. In the example above, the drug is sufentanil, dosage strength is 15 mcg and there are 40 tablets remaining. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 54 STEP 1 Position Device When the patient wants to take a dose they should:
Remove the gray Cap. Hold the System with the same hand as the Patient ID Thumb Tag. First place the Dispenser Tip UNDER your tongue. The patient should then place their thumb (with Patient ID Thumb Tag) on the Blue Dose Button. The Blue Dose Button will flash green, indicating that the System has detected the valid Patient ID Thumb Tag and is ready to dose when the Patient presses the Blue Dose Button with the thumb.. Press the Blue Dose Button with your thumb (with Patient ID Thumb Tag). to dispense the tablet under their tongue. Do not apply downward pressure on the Dispenser tip when dosing. STEP 2 Dispense Tablet The patient will feel the motor vibration start. The System will dispense the tablet. The motor vibration will stop and an audible tone will communicate that the tablet was successfully dispensed. Once the audible tone is heard, the patient can remove the System from their mouth. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 55 Tablet The patient should not chew or swallow the tablet and should not eat or drink for 10 minutes. The patient should minimize talking for 10 minutes. NOTE STEP 3 Administer Additional Doses (if necessary) A blue light will be visible on the back side of the Controller to communicate that the System is locked (for 20 minutes), after which time the patient can receive another dose if needed. The number of tablets will update to reflect the total number remaining. In the example on the left there are now 39 tablets remaining. Place the Cap back on the Dispenser and return to the Holster. Refer to the next page for more information on understanding dose not available (lockout mode). The Systems display will go to sleep (i.e. display turns off) after 30 seconds of System inactivity, but the No Dose Available or Dose Available Light will be lit. To wake up the display (i.e. turn on the display) from sleep, press the Enter/Select or Menu button. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 56 7.2. Understanding Dose not Available (Lockout Mode) During the 20-minute lockout, the System has two ways to communicate that a dose is not available:
Controller Light On-Screen Display A blue light will be visible on the back side of the Controller (see example above). If the Enter/Select Button is pressed to wake up the screen, the front of the Controller will display a blue screen with the message Dose Not Available and list the drug name, dosage strength and number of tablets remaining. example below there are now 39 tablets remaining. In the Refer to the next page for what happens if the patient presses the Blue Dose Button during the lockout period. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 57 What happens if the patient presses the Blue Dose Button during the lockout period?
INFO If the patient were to press the dose button during the 20-minute lockout, the System will announce a negative error tone to communicate no dose is available and the System will record the total number of requests the patient made during the lockout in the Dose History. The total number of requests can be reviewed Section 11, Basic Dose History and Detailed History. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 58 7.3. Cleaning the System During Patient Use If a patient or Healthcare Professional desires to clean any part of the System during use, alcohol wipes should be used. Since the Dispenser is inserted into the patients mouth for dosing, the patient may desire more frequent cleaning of the Dispenser than other portions of the System, possibly after each dose (though this is not required; frequency of cleaning is primarily a personal choice by the patient). Use of the Cap will protect the Dispenser tip from inadvertent contact by patient guests and Healthcare Professionals. If for any reason the patient or Healthcare Professional notices visible contamination, clean the System as follows:
Wipe as necessary with fresh alcohol wipes until the System appears visually clean. Do not saturate any part of the System. Wipes should not be excessively wet; squeeze out excessive liquid from the wipes before use. Let System dry before next patient use. The Dispenser, or entire System, should be replaced if the patient or Healthcare Professional is concerned about severe contamination. DO NOT soak or immerse System in water. WARNING WARNING DO NOT clean the interior portion of the tip. If interior of tip is visibly contaminated, replace the Dispenser. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 59 7.4. Storing the System During Patient Use The System should be stored in the Holster between doses. Use of the Cap is recommended to avoid inadvertent contact between uses. Holster Storage Location Examples It is important to remind the patient to store the System in the Holster when not in use to minimize the chance of inadvertently dispensing a tablet by accidently pressing the Dose Button. If this occurs, the patient should call the Healthcare Professional to retrieve and properly dispose of the loose tablet. NOTE 7.5. Use of the System Patients who do not appear to be able to appropriately use Zalviso should be switched to another form of pain management. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 60 8. Replacing the Patient ID Thumb Tag 8.1. If the Patient ID Thumb Tag is Loose Secure the Patient ID Thumb Tag in place as needed by readjusting it and making sure the ends of the Patient ID Thumb Tag are adhered to the thumb and not to itself. If the Patient ID Thumb Tag continues to be loose, secure it in place by wrapping some medical tape around the thumb on top of the Patient ID Thumb Tag, keeping the same orientation. 8.2. If the Patient ID Thumb Tag is Either Lost, Dropped, Defective or Becomes Non-Functional Remove and discard used Thumb Tag as needed Retrieve a new Patient ID Thumb Tag and an AAC Press the Menu button to access the System Menu, scan the AAC when prompted, then scroll up or down the menu to Thumb Tag Change Select the Thumb Tag Change function from the menu by pressing the Enter/Select button. Follow the screen prompts and affix the new Patient ID Thumb Tag on the patients thumb. NOTE: When the replacement Patient ID Thumb Tag is successfully scanned, you will hear an audible confirmation tone, and the System will transition to the next screen. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 61 Invalid Patient ID Thumb Tag Prompt If a previously used Patient ID Thumb Tag was presented to the System during setup or Patient ID Thumb Tag change, a new Patient ID Thumb Tag is required 1. Obtain a new Patient ID Thumb Tag. 2. Press the Enter/Select Button. 3. Scan the new Patient ID Thumb Tag. NOTE During System use, if the System doesnt receive any inputs (button presses or movement), the screen will turn off (sleep) after 30 seconds. To wake the screen, press the Enter/Select Button or the Menu Button. Upon the screen waking up, the System will have exited the Thumb Tag Change menu and be in Patient mode. To return to the Thumb Tag Menu, press the Menu button to access the System Menu with an AAC, then scroll up or down the menu to Thumb Tag Change, then select the Thumb Tag Change function from the menu by pressing the Enter/Select button. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 62 9. Changing a Cartridge The Cartridge may be changed if the number of tablets is depleted or if the Cartridge is empty. Follow the screen instructions for changing the Cartridge as shown in the first screen below. Refer to Section 5, How to Set Up the System for a New Patient, for instructions on how to prepare the new Cartridge for use with the System. Changing a Cartridge 1. Retrieve a new Cartridge from the medication storage system. 2. Retrieve an AAC. 3. Press the MENU button, access the System Menu with the AAC, and scroll to the Change Cartridge function. Note: The System does not allow the re-use of a partially used Cartridge. 4. Select YES (Left button) if you are sure you want to change the Cartridge. Selecting YES will unlock the Dispenser to initiate changing the Cartridge. Select NO
(Right Button) if you do not want to change the Cartridge and return to the dose status screen. 5. After YES is selected to change the Cartridge, remove the Dispenser by pulling up on the Dispenser. Remove and properly dispose of used Cartridge. 6. Obtain a new Drug Cartridge and prepare it for use as prompted by the screens. Refer to Section 5, Step 6:
Prepare Drug Cartridge. Once Drug Cartridge is prepared, confirm this step on the screen by pressing the Enter/Select Button on the Controller. NOTE: Only a new Drug Cartridge can be used or the System will display an error or notification. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 63 7. Insert the Cartridge into the bottom of the Dispenser
(green arrow on Cartridge label points up). Refer to Section 5, Step 7: Insert Cartridge. Confirm this step on the screen by pressing the Enter/Select Button on the Controller. 8. Snap the Dispenser (with Cartridge attached) onto the Controller. Refer to Section 5, Step 8: Connect Dispenser. 9. Remove Cap (refer to Section 5, Step 9). 10. Eject the Priming Cap (refer to Section 5, Step 10). 11. Re-Cap the System (refer to Section 5, Step 11), to complete the Cartridge change. Cartridge Empty Prompt If the last tablet has been dispensed from the Cartridge, the System will show the Cartridge Empty screen. Used Cartridge Prompt If the Used Cartridge screen is displayed after the Dispenser and Cartridge are snapped into the Controller, the System has detected a used or defective Cartridge. Retrieve a new Cartridge, press the Enter/Select button and follow the instructions to prepare and install the new Cartridge. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 64 Basic History Prompt If the Enter/Select button is pressed instead of the Menu button, the display will transition to the Basic History screens. want to change the Cartridge press the Menu button to go to the Main menu and access the System with the AAC. From here you can change the Cartridge, Discontinue or perform other actions in the Menu. If you There is a three Cartridge limit that can be used in a 72-hour period with one System. Additional Cartridge use beyond three Cartridges within 72 hours will require a new System to be set up. NOTE 3 Cartridge Limit Reached If the 3 Cartridge Limit Reached screen is displayed after Change Cartridge is selected, the third Cartridge is in use in the System and changing the Cartridge will not be permitted. Refer to Note above. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 65 10. Tether Unlock STEP 1 Access Tether Unlock Prompt If for any reason the System needs to be repositioned during patient use, unlock the Tether from the bottom of the Controller. Examples include moving the patient to a wheelchair, bedside chair, walker or gurney, in which case the System can be re-tethered to be in close proximity to the patient. Ensure that the Tether does not get tangled with any equipment lines that may be near the patient, since this could interfere with patient access to therapy. When the patient is being transported, ensure that the Tether does not get tangled in the wheels which may damage the System or jam the wheelchair or gurney. Note: The Security Tether must be reattached in order to continue therapy and the System will not dispense tablets while the Tether is disconnected. STEP 2 Remove Tether 1. Press the Menu button on the Controller. 2. Touch the Authorized Access Card to the Blue Dose Button on the back of the Controller to access the System Menu. 3. Highlight and select the Tether Unlock function by pressing the Enter/Select Button. 4. The System will release the Tether from the bottom of the Controller and display that it is unlocked. Pull down on the Tether to release it and adjust the location of the System. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 66 STEP 3 Securely Attach Tether and Attach Holster to New Location When you are ready to re-secure the Tether, first loop the Tether around the bedrail or another object such as a chair, wheelchair, walker or gurney. Reattach the Tether into the bottom of the Controller. The Controller will sense that the Tether has been inserted and lock automatically. The Holster should be attached to an object near the patient to hold the tethered System
(Refer to Section 5, Step 14). NOTE If the patient is being transported, the System should be tethered to the wheelchair or gurney and the System should be placed in the attached Holster. The patient should only self-administer doses from the System when not in motion. If the patient attempts to dose while in motion, jostling may cause the tablet to miss the patients sublingual space causing a loose tablet. Should this occur, the patient should inform the Healthcare Professional so that the loose tablet can be retrieved and disposed of properly. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 67 11. Basic Dose History and Detailed History 11.1. Basic Dose History The Healthcare Professional can query the System for the basic Dose History of the patient. This review can be done without the use of the Authorized Access Card. Press the Enter/Select Button to access the six basic Dose History screens. STEP 1 Current Status Screen When you first access the Dose History screen it displays the current status. Use the right arrow (press the Right Button) to review other details, such as the dosing totals for the last hour, dosing totals since the last shift reset, dosing totals since the System was setup, and the date/time the shift dosing total was reset. The first screen displays the drug dosage strength, drug type and the tablets remaining in the Drug Cartridge. STEP 2 Last Hour Total Screen The next screen displays the total number of doses dispensed and total requests in lockout by the patient in the last hour. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 68 STEP 3 Activity Each Hour Screen The next screen displays a graphical representation of the dosing history in the last 3 hours. Each row represents an hour of time. The current (most recent) hour is at the top (Row 1). The blinking black cursor is an active indicator of the current hour. In the example at left, Row 1 at the top indicates dosing history in the current hour, or 12:10 to 13:09. Within each row is a representation of the doses dispensed
(represented by a green icon
) and requests made during lock out
(represented by a white icon
). If the number of requests made during lockout exceeds 3, the graph will display as a block which contains the total number of requests during lockout for that time period (see the white block with 4 in the example above). NOTE Using the example screen above, assuming it is 13:09 (1:09PM), the patients dose history is:
Hour 1 (current hour), 12:10 13:09: 2 doses given, 1 request during lockout Hour 2, 11:10 12:09: 3 doses given, 1 request during lockout Hour 3, 10:10 11:09: 3 doses given, 7 request during lockout The nurse should review the dosing history to look for excessive requests during lockout and determine the cause. If a patient does not possess the cognitive ability or manual dexterity to properly use Zalviso, alternative analgesic therapy should be considered. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 69
| 1 | Manual 3/4 | Users Manual | 4.88 MiB |
STEP 4 Shift Total Screen The next screen displays the total number of doses dispensed and requests made by the patient since the last shift reset. STEP 5 Last Shift Reset Screen The next screen displays the date and time the shift dosing total was last reset. STEP 6 Use Total Screen The final screen displays the total number of doses dispensed and requests made by the patient since the therapy was initiated (since first dose). The Use Total time displayed is the elapsed time since the first tablet dosed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 70 11.2. Detailed History The System stores detailed history as an event log that includes data on:
Tether lock and unlock System power on and power off Access using the AAC Patient ID Thumb Tag activation, Drug Cartridge information System setup Access to patient training screens Quantity of successful doses, total doses delivered, patient attempted doses Dispenser removed Cartridge changes Shift reset System Discontinue Remaining battery capacity, battery charger connected or disconnected System alarm and errors The event log is stored in the Systems non-volatile memory; therefore, the event log data is maintained in the System when the System is powered off or if the System experiences an unexpected power loss. The event log cannot be deleted from the System. When the event log reaches its storage capacity, the oldest event is erased to create space for new events in a first-
in-first-out process. Detailed History Access The Healthcare Professional uses the Authorized Access Card (AAC) to review all events that have occurred during System use. STEP 1 Access Detailed History 1. Press the Menu button on the Controller. 2. Touch the AAC to the Blue Dose Button on the back of the Controller to access the System Menu. 3. Highlight and select the Detailed History function by pressing the Enter/Select Button. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 71 STEP 2 View Detailed History Each item displays a time stamp and a message of what event occurred at that time. If a dose was dispensed this is communicated as Dose Given in green text followed by the Patient ID Thumb Tag unique ID number. If a dose was requested during the lockout period this is communicated as Requested in Lockout in blue text. Tether Locked/Unlocked (Tether Connected) AAC access Cartridge changed Shift Reset Patient Training Screens Used (Demo Used) Shift Total and the cumulative dose values associated with that shift The full history is presented as a scrollable list. There is a white scroll bar on the right of the screen to indicate how much content is available before or after the current page of content being viewed. The history is presented with the most recent event on top of the list. As shown in the above example, doses dispensed are shown as Dispensed in green text and dose requests are displayed as Requested in blue text. When you are done reviewing the history, select the Enter/Select Button to return to the System Menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 72 12. Resetting Shift Total The Healthcare Professional can reset the cumulative dose count for the shift. STEP 1 Access Reset Shift with AAC 1. Press the Menu button on the Controller. 2. Touch the AAC to the back of the Controller to access the System Menu. 3. Highlight and select the Reset Shift Total function and press the Enter/Select Button. STEP 2 Press Reset Shift 1. The screen will display the cumulative number of tablets dispensed, the cumulative dose and the total number of requests since the last total reset. 2. Select YES (Right Button) to reset the shift total. NOTE: This function cannot be cancelled. Make sure you want to reset the shift total before selecting Yes. STEP 3 Confirm Reset Shift 1. Select NO (Left Button) to return to the previous screen. 2. Once you have selected YES, the shift totals will display 0. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 73 13. Cleaning During Patient Use The System may need to be cleaned as needed during patient use as described below. The System including all of its components may be cleaned by the patient or Healthcare Professional as needed. When cleaning the System, only alcohol wipes should be used. Wipe as necessary until the System appears visually clean. DO NOT saturate any part of the System. Wipes should not be excessively wet; squeeze out excessive liquid from the wipes before use. The System should be replaced if the patient or Healthcare Professional is concerned about severe contamination. DO NOT soak or immerse System in water. DO NOT clean the interior portion of the Dispenser tip. WARNING WARNING AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 74 14. Discontinuation of Therapy, Disposition of Used Components and Accounting of Remaining Tablets When a patient is finished using the System, the Healthcare Professional will need to Discontinue the System to shut it down and disassemble the used components for disposition. The System will retain the use history for five patients. Refer to Section 20, Reviewing Former Patient Data, for details. Important Safety Message! Due to the risk of accidental exposure and/or overdose, Zalviso must never be dispensed for outpatient pain management or continued after the patient is discharged from the hospital. Do not send any Zalviso tablets, Cartridges, or system components home with any patient upon discharge. 14.1. Discontinuation of Therapy and Disposition of Used Components To Discontinue, perform the following:
STEP 1 Access Discontinue Menu 1. Press the Menu Button near the bottom of the Controller and the System will prompt you to touch the Authorized Access Card to the Blue Dose Button on the back of the Controller to access the System Menu. 2. Scroll to the Discontinue function and select it by pressing the Enter/Select Button. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 75 STEP 2 Confirm Discontinue 1. The screen will ask if you want to discontinue treatment. 2. Record the number of tablets remaining per hospital procedures, including any double signatures or witnessing by a second Healthcare Professional. 3. Press No (Left Button) to return to the previous screen. 4. Press Yes (Right Button) to acknowledge that you would like to Discontinue the System. NOTE: You will not be able to cancel this function. Make sure you want to shut down before selecting Yes. STEP 3 Dispenser Unlocked The System automatically unlocks the Dispenser and Tether. Remove the Dispenser with Cartridge from the System. Press the Enter/Select button to continue. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 76 STEP 4 Dispose of Cartridge to CII Waste Remove the Cartridge from the Dispenser by pulling the Cartridge down. The screen will show a reminder to dispose of the used Cartridge in CII waste. Alternatively, the used Drug Cartridge may be returned to the hospital pharmacy for disposal. Press the Enter/Select button to continue. Tools to aid sufentanil tablet accountability include:
The Controller will display the number of tablets remaining in the Cartridge at the time of System Discontinuation of therapy. The Cartridge Label RFID Reader (see Section 24, Use of Cartridge RFID Label Reader) enables the Healthcare Professional to scan and display the number of remaining tablets in used Cartridges, at the time of System Discontinuation of therapy, as electronically recorded on the Cartridge RFID Label. Manual counting of tablets may be performed on used Cartridges after removal from the System (see Section 14.2, below). This method can be used if discrepancies or diversion is suspected to have occurred. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 77 STEP 5 Dispose Dispenser to Biohazard Waste Reminder to dispose the used Dispenser and Cap into biohazard waste according to institutional procedures. Press the Enter/Select button to continue. STEP 6 Remove Tether, Send Reusable Components to Reprocessing Remove the Tether from the bottom of the Controller. Screen shows reminder to send reusable System components (i.e. Controller, Tether and Holster) to reprocessing. Press the Enter/Select button to continue. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 78 STEP 7 Power Off Device Press the Power Button briefly to shut the System down (screen turns off). Send reusable System components (Controller, Tether and Holster) to reprocessing. Never re-use the Dispenser or Cap with another patient. WARNINGS Never attempt to re-use a Cartridge, either for the same patient or another patient (the System will not allow it). Never remove remaining tablets from a used Cartridge to dose a patient. Remove the used Patient ID Thumb Tag and dispose according to institutional procedures. Reprocess the Controller, Tether and Holster for use with the next patient using the instructions described in Section 17, Reprocessing Instructions. 14.2. Accounting of Remaining Tablets Since the drug tablets are a Schedule II (CII) substance, accounting of tablets is very important after Discontinuation of Therapy. There are three methods for remaining tablet accounting:
1. Electronic - Controller Display During Discontinuation of Therapy 2. Electronic - Cartridge Label RFID Reader 3. Manual Counting Tablets While Still in Cartridge Method 1 can be used when the Cartridge is still contained within the Controller during discontinuation. Method 2 can be used with a stand-alone Cartridge. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 79 Method 3 can be used with a stand-alone Cartridge to count the number of tablets remaining in the Drug Cartridge and confirm the amount of tablets remaining from Methods 1 and 2 above. METHOD 1 Electronic System Display During Discontinuation of Therapy During Discontinuation of Therapy (Section 14.1) the System displays the number of tablets remaining. In the example at left, 12 tablets are remaining. This is the primary method for accounting of remaining tablets. NOTE: as is typical with CII drug, it is recommended to get a witness at this point to verify and document the number of remaining tablets. METHOD 2 Electronic Cartridge Label RFID Reader The Cartridge Label RFID Reader (see Section 24, Use of Cartridge RFID Label Reader) enables the Healthcare Professional to read and display the number of remaining tablets in used Cartridges, at the time of System Discontinuation of therapy, as electronically recorded on the Cartridge Label RFID. In the example at left, 12 tablets should be remaining in the used Cartridge. NOTE: as is typical with CII drug, it is recommended to get a witness at this point to verify and document the number of remaining tablets. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 80 METHOD 3 Manual Counting Tablets While Still In Cartridge All remaining tablets are visible through the clear plastic cartridge. The example shown at left has 12 tablets remaining. To aid counting, magnification is recommended. The tablets can be magnified using reading glasses, or enlarging a photo image taken by a smartphone. A suggested alternative method (when over 10 tablets are remaining), is to print an enlarged image of the tablets using the zoom feature on a photocopier. The tablets can then be counted off on the paper copy with a pen in sets of 5 to facilitate counting the tablets, as shown in the example at left. In this example, there are 12 tablets remaining. NOTE: Regardless of the enlargement method used, be sure to count the 1st tablet as the one in the rectangular slot at the top of the cartridge; this slot is where tablets exit the dispenser during use. NOTE: as is typical with CII drug, it is recommended to get a witness at this point to verify and document the number of remaining tablets. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 81 15. Replacing the System The System will need to be replaced if the 72-hour limit for the System has been reached or when a low battery condition is observed and the patient still requires therapy. Replacement of the System may also need to be done by the Healthcare Professional in the event that the System has become non-functional or experiences an Error that precludes further use. To replace the System:
Follow the steps for Discontinuing the System in Section 14, Discontinuation of Therapy and Disposition of Used Components. The used System should be removed after the discontinuation process. Follow the instructions for setting up a new System as described in Section 5, How to Set Up the System for a New Patient. To return a non-functional or System with an Error that precludes use:
The used System should be returned to biomedical engineering for reprocessing (Section 17, Reprocessing Instructions) and diagnostics (Section 26, Diagnostics). AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 82 16. Notifications, Alerts, Alarms and Errors In addition to dosing information, the System will notify the patient and Healthcare Professional of certain situations:
Notifications (Section 16.1) Alerts (Section16.2) Alarms (Section 16.3) Errors (Section16.2) Refer to each section below for more details. For more information, please refer to Section 26, Diagnostics, for Diagnostic test screens and errors. 16.1. Notifications Notifications are a visual and/or audio signal indicating operating status or a message that may require action, though there is not an unsafe condition. Notifications are indicated with a yellow screen without the ! symbol, and are accompanied by the low level notification tone. The tone and screen will repeat based on the type of message. Review the types of notifications below. For each notification the meaning, example of the screen and the action(s) to take are listed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 83 Notification Type Meaning Action(s) to Take Low Battery 72 Hour Limit Approaching If this screen appears, the battery capacity is getting low to the point where it will soon not be able to continue functioning to delivery therapy (approximately 2 hours) Four green bars mean the battery is fully charged. Two yellow bars means the battery is running low. One red bar means the battery is critically low and the Controller should be discontinued. The 72 hour time limit is approaching. The screen will count down starting at 2 hours, 1 hour and 30 minutes left. This message will re-appear at set intervals if the System is not discontinued. If in patient use, System must be removed and sent for reprocessing and recharging. Do not connect the Charger to the sufentanil sublingual tablet system while it is being used by a patient. Battery charging is only active when the Controller is discontinued. Replace with a new System as needed. If System is being charged, continue charging until battery is completely charged. Press the Menu Button. Scan the AAC (notification is silenced at this point). Proceed to System Menu. Proceed to Discontinue and replace with a new System if required. Reprocess and charge the Controller
(Sections 17 and 18, respectively). The System must be removed from patient use before the time period has expired and replaced as needed for continued therapy. Press the Menu Button. Scan the AAC (notification is silenced at this point). Proceed to System Menu. Scroll to Discontinue and replace with a new System if required. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 84 Notification Type Meaning Action(s) to Take Low Tablet Count Tablet count is getting low. This screen will start notifying of this condition when there are 2 tablets remaining and will re-appear at 1 and 0 tablets remaining. The Cartridge will need to be replaced once empty. If the 3 Cartridge limit has been reached, the System will not permit use of additional Cartridges. A new System will be required to continue therapy. Press the Menu Button. Scan the AAC (notification is silenced at this point). Proceed to System Menu. Scroll to Replace Cartridge option and follow directions. If 3 Cartridge limit has been reached, refer to 3 Cartridge Limit Reached notification below. The System must be removed from use. Press the Enter/Select Button to return to the System Menu. Scroll to Discontinue and replace with a new System if required. Dosing Not Available The System cannot be returned to the patient for dosing. This screen appears when another condition occurred that prompted menu access, but returning to patient mode is not an option, such as 3 Cartridge limit, low battery alarm, etc. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 85 Notification Type Meaning Action(s) to Take Wrong ID Depending on the stage of setup, either the Patient ID Thumb Tag was scanned instead of the AAC, or the AAC was scanned instead of the Patient ID Thumb Tag. During initial power-up, the AAC must be scanned. If this Error message is received at this point, the Patient ID Thumb Tag was scanned accidentally. Scan the AAC to correct this problem. Once in setup, on the Patient ID activation step, if the AAC was scanned accidentally this Error message will appear. Scan the Patient ID Thumb Tag to correct this problem. Invalid Patient ID Thumb Tag A previously used Patient ID Thumb Tag was presented to the System during setup or Patient ID Thumb Tag change. A new Patient ID Thumb Tag is required. 1. Obtain a new Patient ID Thumb 2. Press the Enter/Select Button. 3. Scan the new Patient ID Thumb Tag. Tag. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 86 Notification Type Meaning Action(s) to Take No Cartridge The System was assembled without a Cartridge. If the Healthcare Professional determines that there is no Cartridge in the Dispenser, a Cartridge should be inserted into the Dispenser. If the Healthcare Professional determines that there is a Cartridge present in the System and yet the error message shows up on the System, a new Cartridge should be retrieved and inserted into the System. 1. Press the Enter/Select Button. 2. Follow the screen prompts to remove the Dispenser. 3. Insert a new Cartridge, then proceed with the normal setup outlined in Section 5. 4. Retain the unused Cartridge for reconciliation per institutional procedures governing controlled substances. If this condition persists, notify Biomedical Engineering and set up a new System as needed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 87 Notification Type Meaning Action(s) to Take Used Cartridge The Cartridge that was inserted has been used or tampered with. Remove the Cartridge from the Dispenser and replace with a new Cartridge to continue or begin therapy. 1. Press the Enter/Select Button. 2. Follow the screen prompts to 1. remove the Dispenser. Insert a new Cartridge, and then proceed with the normal setup outlined in Section 5. Retain the used Cartridge for reconciliation per institutional procedures governing CII opioids. 1. Press the Menu button to return to the System Menu. 2. Proceed to Discontinue and replace with a new System if required. 3-Cartridge Limit Reached This screen only appears if a Cartridge change is attempted while on the 3rd Cartridge or if the 3rd Cartridge is empty. Transfer Failed Data transfer from the System to a computer has failed. Repeat steps for Data Transfer. 2. Disconnect the Data Cable from the System. 3. Press the menu button to return to the System Menu. 4. Retry Transfer Data (refer to Section 19). If the error continues after replacing the Data Cable, contact the biomedical technician or contact the manufacturer to arrange for the return of the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 88 Notification Type Meaning Action(s) to Take Pulled Dispenser Detected Patient is pulling down on Dispenser when attempting to dose. End of Use Life Approaching End of Use Life Reached The End of Use Life Approaching screen is displayed only when the Controller is connected to a Charger and the cummulative dose count of the Controller exceeds 27,000 doses, or 90% of the Controller 30,000 dose use life. This alert indicates that the hospital should consider ordering a new Controller within the next several months. The End of Use Life Reached screen is displayed when the cummulative dose count exceeds 29,880 doses, or there are less than 120 doses (3 40-count cartridges) left until the 30,000 dose limit is reached. The Controller cannot be used to setup a new patient, avoiding the possibility of the end of use life occuroing during patient use (up to 3 cartridges). 1. Press the Enter/Select Button. 2. Follow the screen prompts to remind the patient not to pull down on the Dispenser when dosing and observe patient dosing. 3. Two attempts are allowed to retrain the patient on proper dosing. After the second attempt, the System will proceed to Error System Cannot Be Used. (refer to Section 16.2) 1. Press the Enter/Select Button to continue charging the Controller. 1. Press the Enter/Select Button. 2. Follow the screen prompts to power off the Controller. 3. Get another Controller to setup a new patient. 4. Dispose of the old Controller per hospital procedures for battery and electronic waste. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 89 16.2. Alerts and Errors Alerts are a visual and audio signal indicating the need for immediate action, though there is not an unsafe condition. These are represented by a yellow screen with an Alert symbol
(see left) in the in the upper-left corner coupled with a repetitive audible alert tone. System alerts are reviewed below. For each alert; the meaning, example of the screen, and the action(s) to take are listed. A System error is displayed as an alert. Alert Type Meaning Action(s) to Take Low Battery If this screen appears with the ! warning, the battery capacity is too low to continue therapy. If in patient use, System must be removed, reprocessed and charged. If System is being charged, continue charging until battery is completely charged. Do not connect the Charger to the sufentanil sublingual tablet system while it is being used by a patient. Battery charging is only active when the Controller is discontinued. If System is being charged, continue charging until battery is completely charged 1. Press the Enter/Select Button. 2. Scan the AAC (Alert is silenced at this point). 3. Record the tablet count if applicable. 4. Scroll to Discontinue the System. 5. Remove both the Dispenser and Cartridge. 6. Set up a new System as needed. 7. Reprocess and charge the Controller
(Sections 17 and 18, respectively). AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 90 Alert Type Meaning Action(s) to Take Insufficient Battery Power for Use 3 Cartridge Limit Reached During setup, the System checks to see if there is enough power for 72 hours of therapy. If the System does not have enough battery power to be used for therapy, this alert will be displayed. The System must be replaced and charged. 1. Press the Enter/Select Button to exit the setup mode and proceed to the System Menu or 2. Depending on the stage of setup, press the Enter/Select Button and proceed to the Discontinue process. 3. Reprocess and charge the Controller
(Sections 17 and 18, respectively). The System is factory programmed to only allow 3 Cartridges to be used during the 72 hours of therapy with a single Controller. This alert indicates that three Cartridges have been used and no more are allowed with this System. The System must be removed from use. 1. Press the Menu Button. 2. Scan the AAC (Alert is silenced at this point). 3. Press the Right Button below the screen to proceed to the Discontinue process or press the Left button to proceed to the System Menu. Going to the System Menu does not allow exit to patient dosing mode. Select Discontinue from the System Menu and proceed to discontinue the System. 4. Set up a new System as needed. Empty Cartridge All 40 tablets have been dispensed from the Cartridge. A new Cartridge must be loaded if continuation of therapy is desired. 1. Press the Menu Button. 2. Scan the AAC (Alert is silenced at this point). If the 3 Cartridge limit has not been reached, press the Enter/Select Button and proceed to setup with a new Cartridge as prompted. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 91 Alert Type Meaning Action(s) to Take 72 Hour Limit Reached The System is designed for 72 hours of use and the 72 hour time limit has been reached. The System must be removed from use. Press the Menu Button. Scan the AAC (Alert is silenced at this point). Error System Cannot Be Used A System error has occurred. System Errors are accompanied by Error Codes- eg, Error 301, Error 302 etc. In the example at left, the error code is 1234 Press the Right Button below the screen to proceed to the Discontinue process OR press the Left Button to proceed to the System Menu. If you proceed to the System Menu, you will not be able to exit to patient dosing mode, as further patient dosing is not permitted. Select Discontinue from the System Menu and proceed to discontinue the System. Proceed to Discontinue and replace with a new System if additional therapy is needed. The System must be removed from current patient use:
1. Press the Enter/Select Button. 2. Scan the AAC (Alert silenced at this point). 3. Record the tablet count if applicable. 4. Press the Enter/Select Button to discontinue, or, if the System is unresponsive, press and hold the Power Button to power-off the System. 5. Remove both the Dispenser and Cartridge and dispose according to Section 14. 6. Do not reuse the Controller, Dispenser or Cartridge for a new setup. Return the Controller to Biomed for follow up with the manufacturer as described in the note below. 7. Set up a new System as needed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 92 If any System error occurs, the Biomedical Engineering staff (or HCP) should call 1-855-ZALVISO to report the error. Based on the type of error and other system details, the user will be instructed to either reprocess the Controller and return it to use, or return the Controller to the manufacturer. NOTE Alert Type Meaning Action(s) to Take Prime Failed The Priming Cap failed to dispense due to functional error or tampered Cartridge. The System must be removed from use. 1. Press the Enter/Select Button to continue and follow instructions on the screen to discontinue the System. Remove both the Dispenser and Cartridge and dispose according to Section 14. Return the Controller for reprocessing and charging. DO NOT reuse the Controller, Dispenser or Cartridge for a new setup. Set up a new System as needed. 16.3. Alarm Alarms are situations where immediate action is required and a potentially unsafe condition exists. Alarms are indicated by a flashing red screen with an alarm symbol
(see left) in the upper-left corner and a flashing alarm message accompanied by flashing indicator lights and a repetitive audible high-level alarm tone produced by the System which repeats until the Healthcare Professional confirms and responds to the alarm. The audio alarm cannot be silenced and will stop only when System Discontinue is completed. The System has only one alarm condition. This high priority alarm condition will occur only when the Dispenser has been disconnected or pried from the Controller once the System has been set up. If this alarm situation were to occur during patient use, the Healthcare Professional should make an assessment as to whether intentional misuse is AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 93 suspected or if this condition was caused by an accidental dislodging of the Dispenser. If an alarm was to occur, the Healthcare Professional should press the Enter/Select Button and follow the on-screen instructions to Discontinue the System. Alarm Type Meaning Action(s) to Take High Priority Alarm Dispenser Disconnected The Dispenser has become disconnected. Press the Enter/Select button to proceed to Discontinue and replace with a new System
(Replace the Dispenser, Controller and Cartridge). Investigate for cause of alarm to determine if caused intentionally or accidentally. Note: The Dispenser Disconnected alarm screen flashes five times then the Replace Dispenser, Controller, & Cartridge alarm screen flashes five times at a periodic rate. The audio alarm will stop only when Discontinue is completed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 94 17. Reprocessing Instructions 17.1. Reprocessing of Reusable Components Reprocessing is required for the reusable, patient contacting parts of the sufentanil sublingual tablet system, which are the:
Controller Security Tether (Tether) Holster These three reusable parts must be reprocessed before the next patient may use the System. Reprocessing greatly decreases the chance of passing on pathogens from one patient to the next. Reprocessing the Cleaning Plug The Cleaning Plug, used to protect the Charging/Data port during reprocessing of the Controller, must itself be reprocessed after use to avoid potentially transmitting contamination from one Controller to the next. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 95 Reprocessing Instructions Reprocessing consists of two distinct and important steps:
Cleaning cleaning prevents passing contaminants (e.g., food, human waste, bacteria) from one patient to the next. More importantly, it removes dirt and contaminants from the device so that the next step, disinfection, is effective. Disinfection disinfection kills pathogens that may come from the patient (e.g., through touch, blood or other bodily fluids, coughing or sneezing on the device), or may come from Healthcare Professionals or visitors that may handle the device with unclean hands. Effective disinfection helps prevent the spread of disease to the next user of the System. Cleaning and Disinfection Supplies Sani-Cloth Plus Germicidal Disposal Cloths
(Sani-Cloth Plus Wipes) are recommended for both cleaning and disinfecting the Controller, Tether and Holster before use by the next patient, and also for reprocessing the Cleaning Plug. Sani-Cloth Plus Wipes have been shown to effectively clean and disinfect these reusable parts. Sani-Cloth Plus Wipes are manufactured by PDI, and are available through hospital supply stores. These wipes are EPA Registered (Reg. No. 9480-6) and approved for use on hard patient-contacting surfaces in many hospitals in the US. These wipes have been proven to be effective, when the label directions are followed, in killing a broad range of bacteria and viruses typically found in hospital settings. NOTE: If an alternative germicidal wipe is used, the hospital must confirm that the germicidal effectiveness, per the manufacturer, is equivalent to Sani-Cloth Plus Wipes. WARNING It is very important to follow the Sani-Cloth Plus Wipes label instructions for cleaning and disinfecting, which have been incorporated into these reprocessing instructions. Especially important for disinfection of pathogens is to keep the component wet for the full recommended Contact Time of 5 minutes. Anything less than 5 minutes will not assure effective disinfection of the System for the next patient. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 96 Pointed Disposable Cleaning Swabs These should be available for cleaning and disinfecting hard to reach areas on the Controller, Tether and Holster that may accumulate dirt and debris during patient use. As described in the reprocessing instructions below, the swab may be used as a stiffener for a wipe to dig into small crevices, or may be wetted with a wipe and used alone to clean tight areas.
(An example of an effective pointed swab is Qosmedix 10222, Point/Point Cotton Swab, Paper Handle, 3in, manufactured and distributed by Qosina, Edgewood, NY.) Custom Cleaning Plug This is provided to protect the Charging/Data port on the bottom of the Controller during the cleaning step of reprocessing. The Charging/Data port has metal contacts near the opening that may be damaged by germicidal solutions, as are in Sani-Cloth Plus wipes. Only the Cleaning Plug should be used to cover the Charging/Data port during cleaning, otherwise the Controller port contacts may be damaged. Clean Gloves Gloves (Non-latex recommended) should be worn when reprocessing the Controller, Tether, Holster and Cleaning Plug, as recommended by the Sani-Cloth Wipe manufacturer. Gloves not only protect hospital personnel from prolonged contact with the germicidal chemicals in the wipes, but also protect the device from possible contamination from the personnel. Cleaning Brush A soft bristled brush (e.g., Graham Field Adult Toothbrush, Cat. No. 3395-1, available from Fisher Scientific, Cat. No. 19027438) should be used. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 97 Pre-Treatment of the Reusable Part of the System at Point-of-Use, Prior to Reprocessing After discontinuation of patient treatment and the System has been disassembled per the instructions, the reusable parts of the System (Controller, Tether and Holster) should be sent to the appropriate reprocessing center within the hospital. If hospital procedures allow, any part that has excessive contamination at the point-of-use (e.g., has been bled or vomited upon), should be pre-treated by cleaning at the point of use prior to delivery to the reprocessing area. Pre-
treatment helps prevent the spread of pathogens which may be present on the device as it is conveyed to the reprocessing area. In addition, pre-treatment will help remove heavy soil from the device which may otherwise dry, possibly requiring extra effort to thoroughly clean. If hospital procedures permit, pre-treat any heavily soiled, reusable part at point-of-use by carefully performing the cleaning as follows:
Pre-Treatment of Excessively Soiled Controller at Point-of-Use Follow the Cleaning the Controller instructions below. Pre-treatment cleaning only requires gloved hands and Sani-Cloth Plus wipes. If no swabs are available to get into crevices on device, remove as much contamination as possible at point of use; swabs can be used during actual reprocessing cleaning. WARNING If a Cleaning Plug is not available for pre-treatment, take extra care to avoid the charging/data port and Tether hole when cleaning the Controller. See other cautions in the cleaning instructions for the Controller. Pre-Treatment of Excessively Soiled Tether at Point-of-Use Follow the Cleaning the Tether instructions below. Pre-Treatment of Excessively Soiled Holster at Point-of-Use Follow the Cleaning the Holster instructions below. NOTE: In normal use, the Holster clamp metal parts (screw, spring, etc.) are not typically soiled. If the Holster Clamp becomes excessively soiled, dispose the entire Holster in biohazard waste per hospital instructions. After pre-treatment at point-of-use, transport components for reprocessing. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 98 17.2. Reprocessing the Controller WARNING The Controller contains electronic components. Never spray or submerge the Controller use only germicidal wipes. Avoid excessive liquid from the wipes around holes to avoid damage to internal components. WARNING DO NOT contact the Charging/Data port with germicidal wipes these have been found to corrode the metal terminals after successive reprocessing. Avoid wetting the metal contacts of the Charging/Data port, or excessive fluid around the Tether hole or Charging/Data port. Electronic components are exposed and just inside the device and may be damaged by excessive moisture. DO NOT insert a wipe, brush or swab into the Tether port; this may damage the Controller. WARNING Use of the Cleaning Plug is highly recommended. If a Cleaning Plug is not available, take extra care to avoid the Charging/Data port when cleaning the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 99 STEP 1 Insert Cleaning Plug 1. Put on a pair of clean gloves. 2. Insert a cleaned and disinfected Cleaning Plug into the Charging/Data port. The Cleaning Plug should snap into place, just like the charging and data cables. 3. There is no need to plug the Tether port. Use as many fresh wipes as necessary to reprocess the Controller. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 100 STEP 2 Clean the Controller Using a fresh Sani-Cloth Plus Wipe, thoroughly clean the outside surfaces of the Controller, starting with the Dose Button Side. Remove all visible contamination (soil). Use as many fresh wipes as necessary to clean the outside surfaces of the Controller. STEP 3 Clean Dose Button Area STEP 4 Clean Indicator Lights Disinfecting wipes can and should be used generously around the Dose Button since the Dose Button is mechanically sealed to the Controller cover to allow thorough cleaning. Be sure to thoroughly clean the Dose Button and the area between the shell and button. Use swabs, moistened with a Sani-Cloth Plus wipe, to get into crevice around Dose Button. Using a Sani-Cloth Plus wipe wrapped around a swab
(or a swab moistened with a wipe), clean the two lights on the Dose Button side. The black pocket in the top of the Controller (dotted arrow, at left) is covered by the Dispenser during use and need not be cleaned. However, if desired, the pocket may be cleaned with wipes or moistened swabs. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 101 STEP 5 Clean Recessed Area Using a Sani-Cloth Plus wipe wrapped around a swab
(or a swab moistened with a wipe), clean the recessed area as noted in the figure below on the Dose Button Side of the Controller. STEP 6 Clean Seam Using a swab moistened with a Sani-Cloth Plus Wipe, or a wipe held tightly over a gloved fingernail, thoroughly clean the seam that runs around the Controller. STEP 7 Clean Screen Side Using Sani-Cloth Plus Wipes and swabs, thoroughly clean the front side (the screen side) of the Controller. The front side of the Controller has several buttons and a display which are protected by a sealed plastic membrane. Use as many wipes and swabs as needed to thoroughly clean these areas, as well as the crevice between the Controller shell and plastic membrane. Remove all visible soil. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 102 STEP 8 Clean Recessed Areas on Controller Using a Sani-Cloth Plus wipe, wrapped around a swab (or a swab moistened with a wipe), clean the recessed areas as noted in the figure below on the front side of the Controller. STEP 9 Clean Bottom of Controller Thoroughly clean the bottom of the Controller, carefully cleaning around the Cleaning Plug and Tether port. DO NOT insert a wipe, brush or swab into the Tether port; this may damage the Controller. After the Controller has been thoroughly cleaned (all visible soil removed), remove the Cleaning Plug by squeezing on the sides. The Cleaning Plug may now be contaminated and should be set aside for reprocessing. STEP 10 Clean Area Under Cleaning Plug Using a swab moistened with a Sani-Cloth Plus wipe, carefully clean the Controller surface around the bottom of the Controller, avoiding the inside of the Tether port and Charging/Data Port. Thoroughly clean the areas exposed after removing the Cleaning Plug, and areas hard to reach on the outside of the Controller when the Cleaning Plug was in place. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 103 STEP 11 Disinfect the Controller WARNING All external surfaces of the Controller, especially crevices and seams should be thoroughly wetted (being careful to avoid wetting the Charging/Data port and Tether port). Most surfaces will dry within 2-3 minutes, so multiple applications of fresh wipes at each location will be necessary to keep the surfaces wetted for 5 minutes. STEP 12 Thoroughly Wet the Outside of Controller Using a fresh Sani-Cloth Plus Wipe, thoroughly and vigorously wet the entire outside surface of the Controller. Use swabs wrapped in germicidal wipes, or swabs wetted with the wipes to thoroughly wet the crevices and screw holes on the Controller. STEP 13 Use the Brush to Disinfect the Seams WARNING A soft bristled brush MUST be used on the seams of the Controller to ensure disinfection of the seams. Use a soft bristled brush (e.g., Graham Field Adult Toothbrush, Cat. No. 3395-1, available from Fisher Scientific, Cat. No. 19027438) to disinfect the seams on the sides of the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 104 KEEP WET 5 MINUTES Keep the surfaces of the Controller wet for a MINIMUM OF FIVE (5) MINUTES, as recommended by the wipe manufacturer. The full 5 minute wetting (contact) time is important to kill resistant pathogens. STEP 14
(Optional) Disinfect Controller in Two Stages In order to keep all of the surfaces of the Controller wet for the minimum 5 minute time, the Controller may be disinfected in two stages: one with the Dose Button side and left side seam held generally upward and horizontal, and a second stage with the Screen side and right side held generally upward and horizontal. For each stage, the Controller surfaces, crevices and seams should be wetted for 5 minutes. The seams and crevices of the Controller (except the Charging/Data port and Tether port) can withstand thorough wetting, therefore a Sani-Cloth Plus wipe may be wrung in order to allow liquid disinfectant from the wipe to pool in the recess and wick into the crevices. A soft-bristled brush should also be used in the seams and crevices to assure disinfectant penetrates sufficiently. DO NOT use this method around the Data/Charging Port or Tether hole. 1. After all Controller surfaces have been kept wetted for 5 minutes, set the Controller down on a clean dry surface (previously disinfected with Sani-Cloth Plus Wipes) and allow to air dry. 2. Controller reprocessing is now complete. After confirming that the Controller is completely dry, place the reprocessed Controller into a clean storage bag. STEP 15 Air-dry Controller AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 105 Confirm that the Controller is dry before storage. If not completely dry, condensation within the bag or container may harm internal electronic parts. WARNING 17.3. Reprocessing the Controllers Cleaning Plug The Cleaning Plug may be reused to reprocess the next Controller, but should first be cleaned and disinfected, to avoid possible transfer of contamination from one Controller to the next. STEP 1 Clean the Cleaning Plug 1. Put on a pair of fresh gloves. 2. Using a fresh Sani-Cloth Plus Wipe, clean off the outside surface and the inside lip, avoiding the metal contacts inside the Cleaning Plug. Use additional wipes as necessary to clean the plug AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 106 STEP 2 Disinfect the Plug KEEP WET 5 MINUTES 1. Using a fresh Sani-Cloth Plus Wipe, thoroughly and vigorously wet the entire outside surface and inside lip of the Cleaning Plug. 2. Keep the surfaces of the Cleaning Plug wet for a MINIMUM OF FIVE (5) MINUTES, as recommended by the wipe manufacturer. The full 5 minute wetting (contact) time is important to kill resistant pathogens. 3. Allow Cleaning Plug to air dry on a clean dry surface. After confirming the Cleaning Plug is completely dry, store in a clean storage bag. 4. Reprocessing of the Cleaning Plug is complete. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 107 17.4. Reprocessing the Tether STEP 1 Clean the Cable STEP 2 Clean the Tip STEP 3 Clean the Loop 1. Put on a pair of clean gloves. 2. Using a fresh Sani-Cloth Plus Wipe, thoroughly clean the cable portion of the Tether. Use as many fresh Sani-Cloth Plus Wipes as needed to remove all soil from the cable. Using additional wipes, clean the Tether Tip, the metal portion shown in the figure at left. Pay special attention to crevices at the cable-to-tip junction. A wipe wrapped around a swab, or a swab wetted with a wipe may be used to thoroughly clean the tip. 1. Using a fresh Sani-Cloth Plus Wipe clean the Tether loop. Remove all visible soil. 2. Now that the Tether has been thoroughly cleaned, it still needs to be disinfected. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 108 STEP 4 Disinfect the Tether Wet the Cable, the Tip, and the Loop KEEP WET 5 MINUTES STEP 5 Air Dry the Tether 1. Using a fresh Sani-Cloth Plus Wipe, thoroughly and vigorously wet the entire outside surface of the entire Tether, including the Tether tip, Tether cable and Tether loop. Use swabs wrapped in germicidal wipes, or swabs wetted with the wipes to thoroughly wet the crevices on the Tether tip, especially the cable-to-tip junction, and the Tether loop. 2. Allow the surfaces of the entire Tether to remain wet for a MINIMUM OF FIVE (5) MINUTES. 3. THE FULL 5 MINUTE WETTING TIME IS IMPORTANT TO KILL RESISTANT PATHOGENS. 4. If parts of the Tether dry off before 5 minutes have elapsed, use additional wipes to keep surfaces of the Tether wetted for the entire 5 minutes. 1. Set the Tether down on a clean surface
(previously disinfected with Sani-Cloth Plus Wipes) and allow to air dry. Store the reprocessed Tether in a clean storage bag. 2. Tether reprocessing is now complete. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 109 17.5. Reprocessing the Holster STEP 1 Clean the Holster 1. Put on a pair of clean gloves. 2. Using a fresh Sani-Cloth Plus Wipe, thoroughly clean the white plastic portion of the Holster. Use as many fresh Sani-Cloth Plus Wipes as needed to remove all soil from this area, both inside and outside the C of the Holster. 3. Use swabs wrapped in germicidal wipes, or swabs wetted with the wipes to thoroughly clean the crevices on the C of the Holster, especially at the bottom. 4. Using a fresh Sani-Cloth Plus Wipe, thoroughly clean the adjustment knob on the clamp. 5. Now that the Holster has been thoroughly cleaned, it still needs to be disinfected. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 110 STEP 2 Disinfect the Holster KEEP WET 5 MINUTES 1. Using a fresh Sani-Cloth Plus Wipe, thoroughly and vigorously wet all of the surfaces of the white plastic C part of the Holster and the Adjustment Knob on the Holster clamp. Use swabs wrapped in germicidal wipes, or swabs wetted with the wipes to thoroughly wet crevices on the surfaces of the white plastic C part of the Holster and the adjustment knob on the Holster clamp. Keep the surfaces of the entire Holster wet for a MINIMUM OF FIVE
(5) MINUTES. 2. THE FULL 5 MINUTE WETTING TIME IS 3. IMPORTANT TO KILL RESISTANT PATHOGENS. If parts of the Holster dry off before 5 minutes have elapsed, use additional wipes to keep all surfaces wetted for the entire 5 minutes. 4. After 5 minutes have elapsed, set the Holster down on a clean surface
(previously disinfected with Sani-Cloth Plus Wipes) and allow to air dry. After confirming the Holster is completely dry, store the reprocessed Holster in a clean storage bag. 5. Holster reprocessing is now complete. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 111 18. Recharging the Controller Use only the Charger specified for the Controller. Use of any other power supply adapter may damage the Controller or cause personal injury. WARNING WARNING Do not connect the Charger to the sufentanil sublingual tablet system while it is being used by a patient. Battery charging is only active when the Controller is discontinued. The Controllers rechargeable battery should be charged for at least 8 hours or until the Charging Complete message appears on the display screen. If the Controller has been used by a patient, it should always be reprocessed according to instructions in Section 17, Reprocessing Instructions, before following the charging instructions below. STEP 1 Connect Charger 1. Use the supplied Charger only or damage to the Controller may occur. 3. 2. Connect the Charger to a 110/120V 60Hz AC power outlet. The green indicator light on the Charger should light when charging. Insert the end of the Charger into the charging port on the Controller being careful not to insert it into the Tether port. The Charger has polarization keys and can only be inserted into the Controllers charging port in one orientation. The Charger should insert and lock into the Controllers charging port. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 112 STEP 2 Charge Battery Fully Charged Four green bars mean the battery is fully charged. Running Low Two yellow bars means the battery is running low. Fatally Low One red bar means the battery is fatally low and the Controller should be charged. STEP 3 Confirm Charge Complete 1. While the Controllers battery is charging, the display screen will show a Battery Charging message and the battery icon in the upper-
right corner of the screen will animate to show that its charging. On the back of the Controller the blue No Dose light will turn on and flash as a redundant indicator that the Controller is being charged. 2. A battery icon is displayed in the upper-right corner of the Controller screen and is composed of 4 bars. The battery icon will show 4 green bars when it is full and will display one red bar when its fatally low. 3. While charging, the Controller will turn off the display after 30-seconds of inactivity. Moving the Controller will turn on the display and show the charging status. When the battery is done charging the screen will display a message Charging Complete and 4 green bars will display in the upper-right corner of the screen to confirm that the battery is fully charged. The blue LED on the back of the unit will stop flashing and the green LED will be illuminated. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 113
| 1 | Manual 4/4 | Users Manual | 4.31 MiB |
STEP 4 Disconnect and Clean Controller 1. Squeeze the side release latches on the end of the Charger to unlock and remove the end of the Charger from the bottom of the Controller. 2. Power off the Controller by pressing the Power Button. 3. Wipe the Controller with alcohol wipes and allow to dry. 4. Place the Controller in a clean storage bag. 5. Disconnect the Charger from the AC power outlet. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 114 19. Transferring Patient Use Data The Data Cable is available for transferring data from the Controller to other electronic media, if desired. To conduct downloading of the patient use data, which may be performed after a System Discontinuation for each patient, the Healthcare Professional can access the Transfer Data feature via an AAC or TAB. No patient identification information is recorded in the Controller data. Patients usage history is recorded in the Controller data by date and time of use by the patient. NOTE STEP 1Access Transfer Data Screen System Menu
(AAC) Utility Menu
(TAB) STEP 2 Connect Cable 1. The Healthcare Professional must turn the System on by holding down the Power Button for 3 to 4 seconds. 2. The first screen they will see will ask them to touch the AAC or TAB to the Blue Dose Button. This action will present the System Menu or Utility Menu options. 3. Scroll to the Transfer Data option then select it by pressing the Enter/Select Button. 1. Follow the instructions on-screen. 2. Connect the custom Data Cable to the Controllers Charging/Data connector and Computers USB port (the Computer must be running Windows 7 operating system). Ensure the Data Cables connector snaps into the Controllers Charging/Data Port connector. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 115 STEP 3 Launch PC Application 1. To start or launch the PC application software that transfers the patient use data from the sufentanil sublingual tablet system, double click on the Zalviso (sufentanil tablet system) Event Log Download Utility icon on the desktop (present after software installation). If the Windows Open File - Security Warning window is displayed, select Run. 2. A similar Download Utility application window should be displayed, as shown above. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 116 STEP 4 Make New Folder or Select Folder on PC 1. The System should display Device ready to start transfer 2. Using the PC mouse, click on the PC applications Download Folder Location field to activate the Browse For Folder window to display, as shown at left. Make New Folder according to the institutions procedure or select a folder on the PC to transfer the Patient Use Data file to. Then click on OK tablet. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 117 STEP 5 Start Transfer on PC The PC applications Download Folder field should display the folder path selected, as shown below. Using the PC mouse, click on the PC applications Start Transfer button. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 118 STEP 6 Await Transfer The System will display Do NOT Disconnect, Transfer in progress.. DO NOT disconnect the System during the data transfer. The PC application will display Downloading event log and the download status by updating the green status bar. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 119 STEP 7 Confirm Transfer Complete 1. The System will display Transfer Complete once the Patient Use Data is successfully downloaded. 2. Disconnect the Data Cable (by squeezing on the sides) from the Controller. 3. The PC application should display a Transfer complete and 100% green status bar once the Patient Use Data is downloaded successfully. Click on the red X on the upper right-
hand corner of the PC application window to close the application. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 120 Did you receive a Transfer Failed error message?
If any error occurs at this point, follow the on screen instructions to disconnect the Data Cable and try again. Ensure the Data Cables connector snaps into the Controllers Charging/Data Port. If this error continues to occur, replace the Data Cable and try again. If the error continues after replacing the Data Cable, contact the biomedical technician or contact the manufacturer to arrange for the return of the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 121 20. Reviewing Former Patient Data Former patient data can only be accessed using an AAC or TAB before the System has been setup for the next planned patient. It must be selected from the display screen immediately after powering on. Former patient data cannot be accessed while in patient use mode. The System will retain use history for five patients. The System memory follows the first in first out principle for memory allocation, meaning that the first patients data is erased as the sixth patient starts to use the System. No patient identification information is recorded in the Controller data. Patients usage history is recorded in the Controller data by date and time of use by the patient. NOTE STEP 1 Access Former Patient Data Screen To view a former patients data, select the patient by their date and time of first dose. Scroll up or down using the Left or Right button, then pressing the Enter/Select button to select the patient. Press the menu button to return to the previous menu. System Menu (AAC) Utility Menu (TAB) STEP 2 View Patient Data Screen The patients first dose date and time is displayed in the header (e.g. 6/03/2013 11:14, shown in display below). The first display of the patient data initially summarizes the total quantity of tablets and cumulative doses for the selected patient below the header (e.g. 21 Tablets, 315 mcg taken, shown in display below). This summary is not displayed after scrolling up or down. However, the summary can be displayed again by pressing the Enter/Select button to exit, and then reselect the former patient from the Select Patient menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 122 STEP 3 Browse Patient Data The former patients data history is viewed by scrolling up or down using the Left or Right button, respectively. The former patients data displays an event time stamp and a description of the event. A summary of events displayed:
Priming Cap Dispensed Cartridge unique ID number Setup Complete New Pat ID: Patient ID Thumb Tag unique ID scanned at setup or at Change Thumb Tag Battery Level: battery level capacity percentage remaining and battery voltage in millivolts (mV) Tablet Sense Test Passed (or Failed) Doses Given: Displayed in green colored text when a dose is dispensed followed by Patient Thumb Tag ID number in black colored text Request in Lockout: Displayed in blue colored text when a dose was requested during the lockout period Summary of events (continued):
Tether Locked/Unlocked AAC Access followed by its unique card ID number Dispenser Unlatched/Removed Changed Cartridge: Displayed as Cartridge Changed followed by its unique ID number Shift Reset followed by shifts total tablets Error and error code: Displayed in red text as Error or Assert Training Screens Used: Patient training demo selected and corresponding error code or assert error information Power Down and Power Up Tablets Disp: Total quantity of tablets dispensed by patient when System is discontinued Discontinue AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 123 1. If the Controller goes to sleep when at viewing Former Patient Data, wake up the Controller by pressing the menu button and access using the AAC to return the Former Patient Data screen. 2. Press the Enter/Select button to return to the Former Patient data select menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 124 21. Device Information Screen In the event that it is necessary for the Healthcare Professional to retrieve the sufentanil sublingual tablet systems software version or the Controller Serial number, it can be accomplished by accessing the System Menu and selecting the Device Information. When the System is not in patient use, the biomedical technician can access the Utility Menu using the Technician Access Badge (TAB) and select Device Information. STEP 1 Access Device Information 1. Access the System Menu via the AAC or access the Utility Menu via the TAB. 2. The first screen they will see will ask them to touch their AAC or TAB to the Blue Dose Button. This action will present the Menu options. 3. Scroll to the Device Information option in the System Menu or Utility Menu then select it by pressing the Enter/Select Button. System Menu
(AAC) Utility menu (TAB) STEP 2 View Device Information The sufentanil sublingual tablet systems software version and the Controller serial number are displayed. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 125 22. Troubleshooting System components are not serviceable. Tampering, modifying or opening of the System or its components may lead to hazardous conditions. WARNING DO NOT attempt to service the Controller. Opening a System component to attempt troubleshooting or repair will void the manufacturers warranty. NOTE NOTE If any problems are encountered or questions arise during troubleshooting, please call: 1-855-ZALVISO (1-855-925-8476) for assistance. Refer to Section 16 for more information related to System Notifications, Alerts/Errors and Alarms. If the Controller displays a message Error System Cannot Be Used, along with a 3 or 4 digit error cod , please call: 1-855-ZALVISO (1-855-925-8476) for assistance. Depending on the error code and other system details provided to the Call Center, the Controller may be acceptable to return to service after reprocessing/recharging, or may need to be returned to the manufacturer. 22.1. Patient Cannot Dose, but System Appears Normal Check to see that the green light is illuminated indicating that dosing is available. Check basic Dose History screen to see if patient has been receiving doses. Refer to Section 11, Basic Dose History and Detailed History. Check to see that the patient is dosing in an upright orientation. Refer to Section 7, Patient Use. While the Systems dose available green light is illuminated and the System is in an upright orientation, have the patient place his thumb with the Thumb Tag on the Dose Button and observe if Dose Button light flashes. Refer to Section 7, Patient Use. If the patients System orientation during the dose attempt is appropriate and the Dose Button does not flash green, replace the Patient ID Thumb Tag. Refer to Section 8, Replacing the Patient ID Thumb Tag). o If replacing the patients Thumb Tag still does not result in the System permitting the patient to dose, Discontinue the System and set the patient up with a replacement System. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 126 22.2. Patient Cannot Dose, System Appears Unresponsive Press Enter/Select button to see if screen will wake-up. Check to see that the green or blue dosing indicator light is illuminated indicating that the System is on. If the System does not wake-up, or a dose light is not on, remove the System from the patient, and set up the patient with a replacement System. 22.3. Cartridge is not Recognized during Setup or Replacing Cartridge
(Receive No Cartridge Notification) Ensure that a Cartridge has indeed been inserted by removing the Dispenser. Re-insert Dispenser with Cartridge loaded. If the same notification appears, remove Dispenser and replace the Cartridge with a new one. 22.4. Authorized Access Card (AAC) or Technician Access Badge (TAB) is not Recognized by System Ensure that the Display is requesting to Touch access card for menu. Ensure that the AAC or TAB access card is being touched to the large Blue Dose Button on the back of the Controller and that roughly the middle of the access card is over the Dose Button. If the System still doesnt recognize the AAC or TAB, retry with a different AAC or TAB and set malfunctioning AAC or TAB aside. If any error or problem results in the System, AAC or TAB being replaced, please notify the biomedical technician. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 127 22.5. During Change Cartridge or Initial Set Up, the Priming Cap is not observed as being ejected from the System 1. If you did not see the green Priming Cap eject, examine the Dispenser Tip and the surrounding area. If you find the green Priming Cap in the Dispenser Tip remove it and select YES. If you find it in the surrounding area select YES. 2. 3. Select NO (Right Button) if the green Priming Cap failed to eject and then follow the screen instructions to exit setup and discontinue the System. 4. Start over with a new Controller, Dispenser and Cartridge. The Priming Cap is not for patient use, should not be ingested and should be discarded. WARNING 22.6. System Does Not Power On Check that the Controller is charged. Refer to Section 18, Recharging the Controller. Press and hold the Controllers Power Button for at least 5 seconds until the power on tone and display turns on. If the Controller powers on, then powers off and is followed by 3 audible beeps and the Controller powers down, this indicates the Controller has failed Power-On Self-Test. If this occurs, notify the biomedical technician. 22.7. System screen is on but System appears unresponsive Check to see if pressing the Menu button causes the Display to request to Touch access card for menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 128 If the System is unresponsive to accessing the Menu, contact Biomedical Engineering to arrange for removal of the System from the patients room. Place the System away from the patient until it is removed. 22.8. Controller cannot be powered off when not in Patient Use If the Controller is displaying the Touch access card screen or upon waking up, displays the Touch access card screen, scan the AAC to display the System menu. Press and hold the Power Button for about 5 seconds until the Controller powers off. If the Controller is unresponsive to accessing the System menu or does not power off after pressing the Power Button for 5 seconds, contact Biomedical Engineering for removal. 22.9. Dispenser cannot be removed after System is Discontinued Power on the Controller by pressing on the Power Button for about 5 seconds. A System Error should be displayed. Proceed to System Discontinue. Retry removing the Dispenser. If Dispenser cannot be removed, contact Biomedical Engineering for removal. 22.10.Controller powers on then powers off If during Controller power on, 3 audible beeps are generated then the Controller powers off, this indicates the Controller has failed the Power-On Self-Test. Contact Biomedical Engineering for removal of the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 129 23. General Information 23.1. System Information Manufacturing and System Use Manufacturer: AcelRx Pharmaceuticals Address: 351 Galveston Drive, Redwood City, California USA 94063 Phone: 855-ZALVISO (855-925-8476) Model: Zalviso Sufentanil Sublingual Tablet System Classification: Class II equipment, Type BF applied part Operating Conditions: 15C to 40C, 20% to 75% relative humidity System Use Period: Once set up for patient use, each System can be used for a maximum of 72 hours per patient. System notifications are generated when the 72-hour limit is approaching and when 72-hour limit is reached (refer to Section 16, Notifications, Alerts, Alarms and Errors). If additional therapy is required past 72 hours, a new System has to be set up for the patient. System Use Life: Each Controller has a minimum use life of 30,000 doses. Certifications The Zalviso sufentanil sublingual tablet system complies with the applicable requirements of IEC 60601-1: 2012 and its applicable collateral standards The Zalviso sufentanil sublingual tablet system complies with the applicable requirements of FCC Part 15 subpart C (15.225) System Power Source Rechargeable Li-Ion battery, 3.6Vdc, 0.5A peak, 2900mAh Not serviceable AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 130 Charger:
Input: 100-240VAC, 50-60Hz, single phase, nominal input current 0.15Amps @
max load Output: 5V DC 5%, 0.6A Approved for Medical application. Charger is compliant to the applicable requirements of IEC 60601-1, ES 60601-1 and EN 60601-1 Chargers Cord length: 1.8m (72 inches) Interfaces:
Display: 1.8-inch LCD, 176 x 220, TFT, color, white backlight Indicators: Green and blue indicators, Dose Available and No Dose Available indicators, respectively Data port: RS-232 (transmit and receive only) Audio notification tones, alerts and high priority alarm: Internal audio speaker RFID and RFID tags: 13.56 MHz, ISO 15693 Alarm:
One high priority alarm, refer to section 16.3 Sound pressure level (SPL) range at the operators position (0.3m (1-foot)):
50dB(A) to 60dB(A) Radiated Emissions Information Operating Frequency: single frequency, 13.56MHz Number of Channels: One Antenna Type: Multi-turn electrical small loop Type of Modulation: OOK modulation Field strength: 36.9 dB(uV/m) at 30 meters AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 131 Electromagnetic Compatibility Table 1 Guidance and Manufacturers Declaration Electromagnetic Emissions All ME Equipment and ME Systems Guidance and manufacturers declaration electromagnetic emissions The Zalviso sufentanil sublingual tablet system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zalviso sufentanil sublingual tablet system should assure that it is used in such an environment. Emissions Test Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage Fluctuations/
Flicker emissions Group 1 Class A Class A Complies Electromagnetic environment guidance The Zalviso sufentanil sublingual tablet system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Zalviso sufentanil sublingual tablet system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Table 2 Guidance and Manufacturers Declaration Electromagnetic Immunity All ME Equipment and ME Systems Guidance and manufacturers declaration electromagnetic immunity The Zalviso sufentanil sublingual tablet system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zalviso sufentanil sublingual tablet system should assure that it is used in such an environment. IEC 60601 test level Electromagnetic environment Compliance level Immunity test guidance Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 132 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
(50/60 Hz) magnetic field IEC 61000-4-8 1 kV differential mode 2 kV common mode Voltage Dips 30%
reduction, 25/30 periods At 0 Voltage Dips > 95%
reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%
reduction, 1 period At 0 Voltage Interruptions >
95% reduction, 250/300 periods 30 A/m 1 kV differential mode 2 kV common mode Voltage Dips 30%
reduction, 25/30 periods At 0 Voltage Dips > 95%
reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%
reduction, 1 period At 0 Voltage Interruptions >
95% reduction, 250/300 periods 30 A/m Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Zalviso sufentanil sublingual tablet system requires continued operation during power mains interruptions, it is recommended that the Zalviso sufentanil sublingual tablet system be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Caution: Be Cautious Near MRI and X-ray Equipment Keep the Zalviso sufentanil sublingual tablet system away from MRI and X-ray equipment. Strong magnetic fields
(those beyond the levels tested) may cause the device to operate improperly. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 133 Table 3 Guidance and Manufacturers Declaration Electromagnetic Immunity ME Equipment and ME Systems that are NOT Life-supporting Guidance and manufacturers declaration electromagnetic immunity The Zalviso sufentanil sublingual tablet system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zalviso sufentanil sublingual tablet system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000-4-6 3 Vrms 3 Vrms 150 kHz to 80 MHz
(6 Vrms in ISM radio Bands within 150kHz 80MHz) Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.7 GHz 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the Zalviso sufentanil sublingual tablet system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2P d = 1.2P 80 MHz to 800 MHz d = 2.3P 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Zalviso sufentanil sublingual tablet system is used exceeds the applicable RF compliance level above, the Zalviso sufentanil sublingual tablet system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Zalviso sufentanil sublingual tablet system. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 134 Table 4 Recommended Separation Distances between portable and mobile RF Communications equipment and the Zalviso sufentanil sublingual tablet system ME Equipment and ME Systems that are NOT Life-supporting Recommended separation distances between portable and mobile RF communications equipment and the Zalviso sufentanil sublingual tablet system The Zalviso sufentanil sublingual tablet system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Zalviso sufentanil sublingual tablet system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Zalviso sufentanil sublingual tablet system as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m 80 MHz to 800 MHz 800 MHz to 2.7 GHz 150 kHz to 80 MHz W 0.01 0.1 1 10 100 d = 1.2P d = 1.2P d = 2.3P 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 135 Table 5 Immunity to RF Wireless Communications Equipment Immunity to RF Wireless Communications Equipment Test Frequency
(MHz) Band a)
(MHz) Service a) Modulation b) Maximum Power
(W) 385 450 710 745 780 810 870 930 1720 1845 1970 380 390 TETRA 400 430 470 GMRS 460, FRS 460 704 787 LTE Band 13, 17 800 960 1700 1990 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine Pulse modulation b) 217 Hz modulation b) Pulse 18 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz 1.8 2 0.2 2 2 2 Distance
(m) 0.3 0.3 0.3 0.3 IMMUNITY TEST LEVEL
(V/m) 27 28 9 28 0.3 28 28 9 2450 2400 2570 0.3 5240 5500 5785 5100 5800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0.2 0.3 a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 136 FCC Compliance Statements This device is certified under FCC ID: 2AA4P-ARX2006 Part 15.19 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. Part 15.105 This device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device 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. However, there is no guarantee that interference will not occur in a particular installation. Part 15.21 Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 23.2. Inspect Packaging and Components Make sure to inspect the packaging and components as follows:
Inspect all shipping packages and individual packages for damage. Remove the primary packages from the shipping boxes. DO NOT remove components from their primary boxes or primary plastic bags until ready for use. DO NOT remove Cartridges from pouches until ready for use. WARNING 23.3. Storage and Handling All components should be stored at room temperature in a secure location per institutional guidelines. Access should be limited to authorized users. Drug Cartridges contain a Controlled Substance (CII Opioid) and should be stored in an appropriate secure location at controlled room temperature (15 - 30C). AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 137 24. Use of Cartridge Label RFID Reader The Cartridge Label RFID Reader enables the Healthcare Professional to read and display the number of remaining tablets in used Cartridges, as electronically recorded on the Cartridge RFID Label. If necessary, the Cartridge Label RFID Reader can also be used to display the Cartridges detailed information, such as drug name, dosage strength and Drug Cartridges unique RFID number. To read the RFID information on the Cartridge Label, refer to the instructions in this section. To use the Cartridge Label RFID Reader to display the tablets remaining recorded on the Cartridge RFID Label:
STEP 1 Connect to PC STEP 2 Launch PC Software 1. Connect the Cartridge Label RFID Reader to a computers (PC) USB port. The RFID Readers indicator should illuminate indicating power and connection to the USB port. 2. If not already completed, install the Cartridge Label RFID Reader application software that was provided with the Cartridge Label RFID Reader. 1. Execute the Cartridge Label RFID Reader application software. 2. The following screen appears on the computer screen, with Place the Zalviso Cartridge onto the Cartridge RFID Reader. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 138 STEP 3 Introduce Drug Cartridge to RFID Reader Place the used Drug Cartridge onto the Cartridge Label RFID Reader. STEP 4 View Tablets Remaining as recorded on Cartridge Label RFID 1. The number of tablets remaining, as recorded on the Cartridge RFID Label, is displayed on the Cartridge Label RFID Reader application. The sample screen above displays the RFID scan status from a detected Cartridge RFID Label and indicates 14 tablets remaining read from the Cartridge RFID Label. 2. If desired, print the information presented on the Cartridge Label RFID Reader AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 139 application screen by clicking the Print button located on the upper right of the application screen. WARNING If it appears that the tablets remaining as recorded on the Cartridge Label RFID is different than the number of tablets ACTUALLY REMAINING in the Cartridge, diversion may have occurred. See Section 14.2 for manual tablet accounting & reconciliation. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 140 25. Biomedical Technician Utility Menu When not in patient use, the biomedical technician can use a Technician Access Badge (TAB) to access the Controllers utility features consisting of:
Diagnostics (Refer to Section 26) Transfer Data (refer to Section 19) Power Down (Refer to Section 27) Set Time and Date (Refer to Section 28) Former Patient Data (Refer to Section 20) Device Information (Refer to Section 21) Use Life (Refer to Section 29) The utility menu is accessible by the biomedical technician with the use of a Technician Access Badge (TAB). The user will use the TAB to gain access to the System Controllers technician utility menu. The System Controller prompts the user to touch the gray circle of the TAB access card to the blue Dose Button located on the back of the Controller. The TAB does not allow the user to setup the System for its intended use. When the System is in patient use, menu access via the TAB is not allowed by the System. The TAB should not be exposed to X-rays, MRI, or other strong electromagnetic fields. If any problems are encountered or questions arise during use of the Biomedical Technician Utility Menu, diagnostics or troubleshooting, or if an Error has occurred, please call: 1-855-ZALVISO (1-855-925-8476) for assistance. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 141 25.1. Accessing the Technician Utility Menu STEP 1 Power-On Device Turn on the Controller by pressing and holding the Power button for approximately 3 to 5 seconds until the System turns on. The AcelRx startup screen will appear. Ensure that the Controllers battery is fully charged. Refer to Section 18, Recharging the Controller. If the AcelRx startup screen is not displayed and is followed by a 3 audible beeps or if the Controller powers off after the AcelRx startup screen appears, then followed by the display turning off and followed by a 3 audible beeps, this indicates the Controller has failed Power-On Self-Test. If Power-On Self-Test fails, proceed to the What To Do If a Diagnostics Test or Power-On Self-Test Fails section instructions described later in this section. STEP 2 Touch Access Card to Controller 1. The screen will prompt you to touch the circle of the Access Card to the blue Dose Button on the BACK of the Controller. 2. Touch the gray circle of the TAB access card to the Blue Dose button on the Controller. The System will announce a tone to confirm that the System has successfully read the card. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 142 STEP 3 View Utility Menu The Utility Menu will be displayed on the Controller screen on the front of the Controller. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 143 26. Diagnostics The Utility menu Diagnostics feature provides capabilities for the biomedical technician to check the Controllers functions if there is an operational issue during normal System use by the nurse or patient. 26.1. Accessing the Diagnostics Screen STEP 1 Navigate to the Diagnostics Screen 1. To access the Diagnostics menu from the Utility menu, scroll to Diagnostics then press the Enter/Select button. 2. The Diagnostics Menu will be displayed on the Controller screen on the front of the Controller. STEP 2 View the Diagnostics Screen The Diagnostics Menu displays a list of functional tests:
Tether motor test LED indicators Dispense motor test Sound test RFID check Accelerometer test Buttons When in the Diagnostics Menu, select a functional test by using the Left/Right button to scroll to a functional test until highlighted in bold then press the Enter/Select button. To return to the Utility Menu from the Diagnostics Menu, press the Menu button. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 144 26.2. Diagnostic Test Descriptions If any of the following diagnostic tests fail or do not operate as indicated please proceed to the What To Do If a Diagnostics Test or Power-On Self-Test Fails instructions described later in this section. NOTE TETHER MOTOR TEST Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Runs the Controllers tether motor to Tether latch position then returns to Tether unlatch position. Verify the Controllers Tether motor sound and feel as the motor runs to the Tether latch and Tether unlatch positions. The Controller is defective if theTether Motor Test fails. Do not install a Tether into the Controller during the Tether motor test. Press on the Enter/Select button to return to the Diagnostics Menu. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 145 LED INDICATORS Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Lights and flashes the Controllers Dose Available, No Dose Available and Blue Dose Button indicators in sequence. After pressing the Enter/Select button, look at the indicators on the back side of the Controller. Verify the Controllers Dose Available, No Dose Available and Blue Dose Button indicators light and flashes. Press on the Enter/Select button to return to the Diagnostics Menu. If the technician verifies the Controllers LED indicators do not light and flash, then the LED Indicators Test has failed. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 146 DISPENSE MOTOR TEST Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Runs the Controllers dispense motor to the Dispenser latch position then returns to Dispenser unlatch position. Verify the Controllers dispense motor sound and feel as the motor runs to the Dispenser latch to Dispenser unlatch positions. The Controller is defective if the Dispense Motor Test fails. DO NOT install a Dispenser into the Controller during the Dispenser motor test. Press on the Enter/Select button to return to the Diagnostics Menu. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 147 SOUND TEST Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Generates the Controllers six audible tones in sequence. Verify six audible tones are generated in sequence (i.e. Power On, Power Down, Confirmation, Negative, Low Level Alert and Dose tones). If the technician verifies the Controller does not generate all six audible tones, then the Sound Test has failed. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. Press on the Enter/Select button to return to the Diagnostics Menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 148 RFID CHECK Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Verify the System secure access component (i.e. AAC, TAB or Patient ID Thumb Tag) is found and displayed when placed against the Controllers Blue Dose Button. Scans for a System secure access component such as the AAC, TAB and Patient ID Thumb Tag. When Scan an ID is displayed, technician places System secure access component against the Controllers Blue Dose Button. Press on the Enter/Select button to return to the Diagnostics Menu. If the technician verifies the Controller does not detect and display the secure access component against the Controllers Blue Dose Button (i.e. AAC, TAB or Patient ID Thumb Tag), then the RFID Check has failed. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 149 ACCELEROMETER TEST Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Checks the Controllers orientation accelerometer is functional. Accelerometer test displays an orientation circle. When the Controller is in the proper dosing position (i.e. upright) the orientation cicle should be green. When the Controllers in the improper dosing position
(i.e. sideways) the orientation cicle should be blue. Technician starts with the Controllers orientation in the upright position and verify the orientation cicle is green. Rotate the Controller in a circular motion through various orientations and verify the orientation cicle changes from green to blue then back to green. Verifying the orientation circle color while rotating the Controller 360 in the vertical axis is one method to check the accelerometer functionality. Press on the Enter/Select button to return to the Diagnostics Menu. If the technician verifies one of the following:
The orientation circle does not change to green when the Controller is an upright position. When the Controller is rotated 360 in the vertical axis the orientation circle does not change color. Then the Accelerometer Test has failed. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 150 BUTTONS TEST Diagnostic Test Functional Test Description Technician Functional Check If Functional Check Fails Checks the Controllers buttons are functional. When the Push a button is displayed, press one of the Controllers Menu button, Power button, Left button, Right button, Blue Dose Button or the Enter/Select
(Center) button. While pressing the Controllers Menu button, Power button, Left button, Right button, Blue Dose Button or the Enter/Select button, verify the corresponding button name is displayed. If the technician verifies a Controllers button is not detected when pressed, then the Buttons Test has failed. Contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. Press on the Enter/Select button to return to the Diagnostics Menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 151 What To Do If a Diagnostics Test or Power-On Self-Test Fails If during Controller power on, 3 audible beeps are generated then the Controller powers off, this indicates the Controller has failed the Power-On Self-Test. If the biomedical technician verifies that a Controller repeatedly has a System Error, fails Diagnostics or fails Power-On Self-Test, contact the manufacturer to arrange the return of the Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturers contact information. WARNING System components are not serviceable. Tampering, modifying or opening of the System or its components may lead to a hazardous condition, and will void the manufacturers warranty. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 152 27. Power Down from Utility Menu The Utility menu Power Down feature provides capabilities for the biomedical technician to power off the Controller. Power Down To power off the Controller from the Utility menu, scroll to Power Down then press the Enter/Select button. The Controllers display and indicators should turn off, and the power down tone should be audible during power down. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 153 28. Set Time and Date The Utility menu Set Time and Date feature provides capabilities for the biomedical technician to set the Controllers time and date when not in normal use. Setting the Controllers 24-hour format time and date should be performed by the biomedical technician:
Upon receipt of Controller from the manufacturer, Upon applicable annual standard and daylight time changes, or When Controllers displayed time and/or date does not correspond to the institutions time and/or date STEP 1 Navigate to Time & Date Screen 1. To set the Controllers time and date from the Utility menu, scroll to Set Time & Date then press the Enter/Select button. STEP 2 Set Hours & Minutes 1. The Controllers time is displayed in a 24-hour format. An example of 24-hour time format compared to 12-hour time format is shown in the table below. To set the Controllers hour, use the right and left buttons to set the hour value. Then press the Enter/Select button. 12 Hour Time Format 24 hour Time Format 12:30 AM 4:14 AM 7:45 PM 11:59 PM 00:30 04:14 19:45 23:59 AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 154 2. To set the Controllers minutes, use the right and left buttons to set the minute value. Then press the Enter/Select button. STEP 3 Set Year, Month & Day 1. To set the Controllers year, use the right and left buttons to set the year. Then press the Enter/Select button. 2. To set the Controllers month, use the right and left buttons to set the month value. Then press the Enter/Select button. 3. To set the Controllers day, use the right and left buttons to set the day value. Then press the Enter/Select button. 4. Press the Enter/Select button to return to the Utility menu. If an error was made in setting any of the values, access the Utility Menu and select Set Time and Date and start over. NOTE AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 155 29. Use Life The Utility menu Use Life feature provides capabilities for the biomedical technician to display the cumulative dose count and total doses remaining until end of use life of the sufentanil sublingual tablet system Controller. A total count of 30,000 doses dispensed is the end of use life limit of the Controller. The Controller software will not allow the System to be set up for a new patient if the end of use life could possibly be reached during patient use, i.e., the end of use life of 30,000 doses could be reached in 3 cartridges of 40 tablets each. At the end of use life, the Controller should be disposed of according to hospital procedures for battery and electronic waste. Refer to End of Use Life Approaching and End of Use Life Reached notifications in Section 16.1. STEP 1 Navigate to Use Life Screen To view the Use Life from the Utility menu, scroll to Use Life then press the Enter/Select button. STEP 2 View Use Life 1. The Use Life screen displays the use life of the sufentanil sublingual tablet system. The example Use Life display indicates the sufentanil sublingual tablet system has 13,000 doses given and 17,000 doses remaining until end of use life of the Controller is reached. 2. Press the Enter/Select button to return to the Utility menu. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 156 ATTACHMENT 1:
Patient Reference Sheet PL-1752 Rev. E AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 157 Patient Reference Sheet Zalviso (sufentanil sublingual tablet system) Take a dose when needed for pain relief or before an activity that may increase your pain. For your safety, the System will make you wait at least 20 minutes between doses. DO NOT share this medication. DO NOT dispense tablets into your hand and take them later. DO NOT take into the shower or submerge in liquid. Call a nurse if you spill liquid on the System. When can I take a dose?
Dose Available
(Green Light) You may take a dose if needed. How do I take my dose?
Dose Unavailable
(Blue Light) You cannot take a dose. Remove the Cap and hold the System in your hand that has the Patient ID Thumb Tag. Do not touch or press the Blue Dose Button with your thumb until the Dispenser tip is under the tongue. Keep the System relatively upright to dose. First place the Dispenser tip UNDER your tongue and THEN press the Dose Button with your thumb. Do not apply downward pressure on the Dispenser tip when dosing. Keep the Dispenser tip under your tongue until you hear the dosing tone and feel the motor vibration stop. Store the System in its Holster in between doses to minimize the chance of inadvertent dispensing of a tablet. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 158 DO NOT chew or swallow the tablet. DO NOT eat or drink and minimize talking for 10 minutes after taking a dose. Call the nurse if the System is continuously beeping and flashing between doses. Call the nurse if you have any trouble taking a dose or keeping the tablet under your tongue. Call the nurse if you accidentally dispense a tablet when you are not taking a dose, or if you see one or more loose tablets. AcelRx Pharmaceuticals, Inc. Zalviso sufentanil sublingual tablet system Instructions for Use PL-1678 Rev. K 159 Signature Manifest Document Number: PL-1678 Title: PL-1678 ZALVISO sufentanil sublingual tablet system - Instructions For Use Revision: K All dates and times are in Pacific Standard Time. PL-1678 Rev J to K Zalviso IFU Change Request Name/Signature David Freed (DFREED) Sundaravel Ananthavel
(SANANTHAVEL) Kathy Wilson (KWILSON) Collaboration Name/Signature Tammy Le (TLE) Brandon Pe (BPE) Anil Dasu (ADASU) Bill Callahan (BCALLAHAN) Casidy Domingo (CDOMINGO) David Freed (DFREED) Kimberly Gaumer (KGAUMER) Lana Chin (LCHIN) Noel Singh (NSINGH) Sundaravel Ananthavel
(SANANTHAVEL) Angie Griffin (AGRIFFIN) Majella Dooley (MDOOLEY) Mark Curtiss (MCURTISS) Samir Shah (SSHAH) Al Landas (ALANDAS) Kathy Wilson (KWILSON) ENG-MGR Approval Title Executive Director, Quality Date Director, Quality Meaning/Reason Sr. Manager, Document Control 14 Jan 2019, 12:45:26 PM Approved Title Manager, Quality Manufacturing Buyer/Planner CHIEF ENGINEERING OFFICER Sr. Director Manufacturing Ops Director, Engineering Executive Director, Quality VP Regulatory & Quality Assura Assoc Dir Regulatory Affairs Director, Supply Chain Director, Quality Sr Director Project Management SENIOR DIRECTOR REGULATORY AFF Senior Manager, Quality Manager, Product Manufacturing Director, Elect., Software Eng Sr. Manager, Document Control Date Meaning/Reason In Process In Process Complete Complete Complete Complete Complete 16 Jan 2019, 11:30:11 AM 18 Jan 2019, 11:49:54 AM 04 Feb 2019, 09:48:42 AM 04 Feb 2019, 03:41:51 PM 05 Feb 2019, 11:06:02 AM Name/Signature Bill Callahan (BCALLAHAN) Casidy Domingo (CDOMINGO) Noel Singh (NSINGH) Angie Griffin (AGRIFFIN) Brandon Pe (BPE) Samir Shah (SSHAH) Anil Dasu (ADASU) Date Title Sr. Director Manufacturing Ops Director, Engineering Director, Supply Chain Sr Director Project Management Manufacturing Buyer/Planner Manager, Product Manufacturing CHIEF ENGINEERING OFFICER 13 Feb 2019, 12:48:19 PM Meaning/Reason Approved QA-MGR Approval Name/Signature Title Date Meaning/Reason Tammy Le (TLE) David Freed (DFREED) Kimberly Gaumer (KGAUMER) Sundaravel Ananthavel
(SANANTHAVEL) Mark Curtiss (MCURTISS) Originator Approval Manager, Quality Executive Director, Quality VP Regulatory & Quality Assura Director, Quality Senior Manager, Quality 06 Feb 2019, 09:22:22 AM Approved Name/Signature Al Landas (ALANDAS) Title Director, Elect., Software Eng Date 05 Feb 2019, 11:18:23 AM Meaning/Reason Approved DOC-MGR Approval Name/Signature David Freed (DFREED) Sundaravel Ananthavel
(SANANTHAVEL) Kathy Wilson (KWILSON) REG-MGR Approval Title Executive Director, Quality Date Director, Quality Meaning/Reason Sr. Manager, Document Control 05 Feb 2019, 11:06:28 AM Approved Name/Signature Kimberly Gaumer (KGAUMER) Lana Chin (LCHIN) Majella Dooley (MDOOLEY) Title VP Regulatory & Quality Assura Assoc Dir Regulatory Affairs SENIOR DIRECTOR REGULATORY AFF Doc Control Set Date Collaboration Step Date Meaning/Reason 05 Feb 2019, 08:14:20 PM Approved Name/Signature David Freed (DFREED) Sundaravel Ananthavel
(SANANTHAVEL) Kathy Wilson (KWILSON) DOC-MGR Final Approval Name/Signature David Freed (DFREED) Sundaravel Ananthavel
(SANANTHAVEL) Kathy Wilson (KWILSON) Notify Name/Signature Tammy Le (TLE) Brandon Pe (BPE) Samir Shah (SSHAH) Anil Dasu (ADASU) Angie Fuentes (AFUENTES) Al Landas (ALANDAS) Bill Callahan (BCALLAHAN) Ben Yaffe (BYAFFE) Casidy Domingo (CDOMINGO) David Freed (DFREED) Title Executive Director, Quality Date Director, Quality Meaning/Reason Sr. Manager, Document Control 13 Feb 2019, 01:51:57 PM Complete Title Executive Director, Quality Date Director, Quality Meaning/Reason Sr. Manager, Document Control 13 Feb 2019, 01:52:23 PM Approved Date Title 13 Feb 2019, 01:52:24 PM Manager, Quality 13 Feb 2019, 01:52:24 PM Manufacturing Buyer/Planner Manager, Product Manufacturing 13 Feb 2019, 01:52:24 PM CHIEF ENGINEERING OFFICER 13 Feb 2019, 01:52:24 PM Material's Testing Logistics 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM Director, Elect., Software Eng Sr. Director Manufacturing Ops 13 Feb 2019, 01:52:24 PM CONTRACTOR, ENGINEERING 13 Feb 2019, 01:52:24 PM Director, Engineering 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM Executive Director, Quality Meaning/Reason Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Kimberly Gaumer (KGAUMER) Kathy Wilson (KWILSON) Lana Chin (LCHIN) Mark Curtiss (MCURTISS) Majella Dooley (MDOOLEY) Noel Singh (NSINGH) Sundaravel Ananthavel
(SANANTHAVEL) Angie Griffin (AGRIFFIN) VP Regulatory & Quality Assura Sr. Manager, Document Control Assoc Dir Regulatory Affairs Senior Manager, Quality SENIOR DIRECTOR REGULATORY AFF Director, Supply Chain Director, Quality 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM 13 Feb 2019, 01:52:24 PM Sr Director Project Management 13 Feb 2019, 01:52:24 PM Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Email Sent Quick Approval Approve Now Name/Signature Kathy Wilson (KWILSON) Title Sr. Manager, Document Control Date 15 Feb 2019, 03:01:12 PM Meaning/Reason Approved
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2019-02-21 | 13.56 ~ 13.56 | DXT - Part 15 Low Power Transceiver, Rx Verified | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 | Effective |
2019-02-21
|
||||
| 1 | Applicant's complete, legal business name |
AcelRx Pharmaceuticals Inc.
|
||||
| 1 | FCC Registration Number (FRN) |
0017240185
|
||||
| 1 | Physical Address |
351 Galveston Drive
|
||||
| 1 |
Redwood City, California 94063
|
|||||
| 1 |
United States
|
|||||
| app s | TCB Information | |||||
| 1 | TCB Application Email Address |
t******@intertek.com
|
||||
| 1 | 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 | Grantee Code |
2AA4P
|
||||
| 1 | Equipment Product Code |
ARX2006
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 | Name |
A****** L********
|
||||
| 1 | Title |
Director, Electrical & Software Engineering
|
||||
| 1 | Telephone Number |
65021********
|
||||
| 1 | Fax Number |
65021********
|
||||
| 1 |
a******@acelrx.com
|
|||||
| app s | Technical Contact | |||||
| 1 | Firm Name |
AcelRx Pharmaceuticals Inc.
|
||||
| 1 | Name |
A**** L******
|
||||
| 1 | Physical Address |
351 Galveston Drive
|
||||
| 1 |
Redwood City, 94063
|
|||||
| 1 |
United States
|
|||||
| 1 | Telephone Number |
65021********
|
||||
| 1 |
a******@acelrx.com
|
|||||
| app s | Non Technical Contact | |||||
| 1 | Firm Name |
AcelRx Pharmaceuticals Inc.
|
||||
| 1 | Name |
A**** L******
|
||||
| 1 | Physical Address |
351 Galveston Drive
|
||||
| 1 |
Redwood City
|
|||||
| 1 |
United States
|
|||||
| 1 | Telephone Number |
65021********
|
||||
| 1 |
a******@acelrx.com
|
|||||
| app s | Confidentiality (long or short term) | |||||
| 1 | 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 | 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?: | No | ||||
| 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 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 | Equipment Class | DXT - Part 15 Low Power Transceiver, Rx Verified | ||||
| 1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Zalviso Sufentanil Sublingual Tablet System | ||||
| 1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 | Modular Equipment Type | Does not apply | ||||
| 1 | Purpose / Application is for | Original Equipment | ||||
| 1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 | 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 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 | 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 | Firm Name |
IntertekTesting Services NA Inc.
|
||||
| 1 | Name |
C**** P******
|
||||
| 1 | Telephone Number |
650-4********
|
||||
| 1 | Fax Number |
650 4********
|
||||
| 1 |
c******@intertek.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15C | 13.56000000 | 13.56000000 | |||||||||||||||||||||||||||||||||||||
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