TPN Manager
Help Files
AMD
Table of
Contents
Introduction
Setup/Customization
Process Overview
Warnings & Cautions
Sign On Account
Patient File
Nutritional Assessment
TPN Order Entry
TPN Authorization
Ca/P Compatibility
Base Solutions
Additive Solutions
Schedule Queues
Printing Labels
Compounding
Reports
Backup & Restore
Shutting Down
Troubleshooting
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TPN Manager Software Warnings and Cautions

  The following Warnings and Cautions should be observed whenever using the TPN Manager Software:
Caution WARNINGS
  • The product help screens contain abbreviated instructions on the use of the Pinnacle TPN Management System.  Please read them completely prior to using this product.  They are is intended to reinforce the teaching given to the user by a trained health care professional or an authorized B. Braun representative.
  • User should exercise care and proper pharmacy procedures so as to avoid incompatible solution combinations when compounding.
  • Prior to initiating the compounding of a solution formula, it is recommended that the User follow careful labeling practices and to place label on the Pinnacle Compounder Final Container prior to compounding, including when using Standard Formulas.
  • Prior to initiating the compounding of a solution formula, it is recommended that the User follow careful labeling practices and to place label on any required source containers prior to compounding.
  • Pharmacy policies and procedures and use of proper aseptic technique should be followed at all times.
  • To avoid unauthorized access to critical Compounder data, it is strongly recommended that production distribution (default) access names be changed upon initial product use.  Critical compounding errors can thus occur under this scenario.  Changing the access names is also highly recommended to protect patient information for HIPPA compliance.
  • Following the entry of or changes to data in the system/solution information database, the User should perform an independent audit to ensure the accuracy of this data.
  • When using the TPN Manager Software, in conjunction with the Pinnacle Compounder, the User should:
    • Not manipulate program or database files other than to backup and restore database files.
    • Ensure only trained and authorized personnel are responsible for prescription input and other data entry.
    • Audit the entry of any database data after data changes or initial entry.
    • Should save data and/or exit the system as instructed so as to avoid unintentional data corruption.
  • When using Order Program Bar Codes generated by Third Party software systems, in conjunction with the Pinnacle Compounder:
    • It is strongly recommended that bar codes provided by other software providers to program the Pinnacle Compounder only be used when the software provider also provides a hard copy order sheet, order worksheet, or other order documentation that can be used by the pharmacist or pharmacy technician to ensure that the Pinnacle Compounder screen has been correctly programmed.
    • It is strongly recommended that prescription changes not be allowed at the Control Panel when using Third Party software generated bar codes (Locked Order Program Bar Code control option)
    • Prior to using bar codes provided by other software providers to program the Pinnacle Compounder, the user must ensure that:
    • When using bar codes provided by other software providers to program the Pinnacle Compounder, the user must ensure that:
      • The Solution Name that appears on the compounder screen corresponds to the Solution Name that appears on the software provider order sheet, order worksheet, or other order documentation.
      • The Third Party software system utilizes Pharmacy security layers during set up
      • The Third Party software system User Documentation instructs the user to audit the Third Party software system data after the entry of any database data, after data changes, or initial entry
      • The Third Party software system User Documentation instructs the user to ensure Solution Confirmation Bar Code Numbers and/or Order Program Bar Code Drug ID Numbers have been correctly entered in both the third party and Pinnacle solution databases
      • The Third Party software system should have selected solution data pre-entered in its marketed product
      • The Third Party software system User Documentation instructs that only trained and authorized personnel should be responsible for data and prescription input at the Third Party software system
      • The Third Party software system Operator logon should have security checks
      • The Third Party software system should restrict access to patient orders after order authorization
  • When using the Pinnacle Compounder, should the User encounter a situation where their input of information into or out of the Control Panel is unsuccessful or inconsistent with its expected response, the User should immediately discontinue use of the Pinnacle Compounder and contact B. Braun Medical Inc. Technical Product Support for further disposition instructions.
  • Should an unexpected adverse system state occur when compounding a solution formula, the indicated information on the Control Panel may be inaccurate and, as a result, the Final Container in the process of being filled should be immediately discarded and not provided for patient use.
  • The User should consider a filled Final Container as successfully compounded ONLY when indicated as such by the information provided on the Control Panel.
  • The Pinnacle Compounder should only be used with appropriately grounded electrical outlets.
  • Always disconnect the electrical power cord from the outlet before cleaning to prevent electrical shock.
  • When used with the Pinnacle Compounder:
    • User should visually verify correct source solutions on appropriate pump stations prior to the commencement of compounding.
    • When programming a formula to be compounded in the Pinnacle TPN Management System, the User should ensure the correct solution is selected at the Control Panel.
    • Prior to initiating the compounding of a solution formula, it is recommended that the User:
      • Visually inspect the Pinnacle Compounder Transfer Set for end protectors that are not in place, broken tubing, or breach in component integrity before installation.
        • The use of a Transfer Set should be discontinued and discarded if its protector tips are off when removed from packaging.
        • The use of a Final Container should be discontinued and discarded if its protector tip is off when removed from packaging.
        • The use of a Vented Spike or Vented Micro Spike should be discontinued and discarded if its protector tips are off when removed from packaging.
      • Visually inspect Source Container solutions for expiration dating, length of use, and particulate or other inappropriate materials before use.
        • Opened source solutions used in conjunction with the Pinnacle Compounder should be replaced in an appropriate time frame.
        • Expired Source Container solutions are not recommended for use with the Pinnacle Compounder.
  • Prior to initiating the compounding of a solution formula and following the successful completion of a compounded solution formula, the User should observe the state of the source solution containers and compare known/expected final fill volumes to delivered volumes.
  • Following the successful completion of a compounding operation, the User should visually inspect the filled Final Container for proper solution appearance.
  • Following the successful completion of a compounded solution formula, the User should observe and compare the known/expected final fill volume to the load cell reading.
  • When operating the Pinnacle Compounder Pump Module in a laminar flow hood, User should exercise care and use proper aseptic technique when connecting source solutions, final containers, or spike adapters to the transfer set.
  • The Pinnacle Compounder Pump Module should only be used in a properly functioning, calibrated and certified laminar flow hood.
  • When preparing the Pinnacle Compounder for use, the User should ensure that Transfer Set, Final Container, and Spike Adapter tip protectors are in place when its respective package is opened prior to use.
  • When preparing the Pinnacle Compounder for use, following installation of the Transfer Set and prior to use, the User should sterile swab the manifold outlet connector septum.
  • The Pinnacle Compounder Transfer Set should be flushed whenever a source solution is changed in accordance with provided operating instructions.
  • The Pinnacle Compounder Transfer Set should be installed into the Pump Module in accordance with instructions printed on set packaging.
  • The Pinnacle Compounder Transfer Set should be replaced in accordance with its stated maximum use period.
  • The Pinnacle Compounder Source Solution Containers, Transfer Set, Final Containers, and Spike Adapters must only be used in accordance with associated product documentation and use instructions.
  • The User should be aware and take into consideration when programming solutions for compounding that the Transfer Set manifold contains approximately 0.5 mL of common volume prior to solution exit to the Final Container spike (i.e., solution volume that is not separated by an individual fluid pathway).
  • The User should observe that Final Container does not interfere with Pump Module or other surfaces before or during a compounding cycle.
  • The Pinnacle Compounder provides an option to require bar-coding confirmation of source solutions prior to allowing compounding.  It is strongly recommended that this option be enabled.
  • The Pinnacle Compounder provides an option to require Pharmacist Approval of programmed source solutions and their respective volumes prior to allowing compounding.  It is strongly recommended that this option be enabled.
  • Should a No Flow or other alert or alarm condition be encountered when using the Pinnacle Compounder, the User should utilize the associated product help instructions (HELP(?)) for proper response actions.
  • It is intended that a successfully filled TPN Final Container solution only be administered to a patient via an infusion pump.
  • When using the Pinnacle Compounder, the User should:
    • Not manipulate program or database files other than to backup and restore database files.
    • Audit the entry of any database data after data changes or initial entry.
    • Should save data and/or exit the system as instructed so as to avoid unintentional data corruption.
  • The Pinnacle Compounder Control Panel has been designed for placement and use outside the laminar flow hood.  It has not been designed for protection against fluid spills.
  • The Pinnacle Compounder is not to be used in the presence of combustible solutions or vapors.

CAUTIONS
  • Before using the TPN Management System in a clinical setting, the User should become thoroughly familiar with the proper use of the TPN Management System as outlined in these Help Screens.
  • The Pinnacle Compounder utilizes state of the art electrical components which may be damaged if exposed to high levels of electrostatic discharge (ESD).  User should only use compounder in an environment with minimal ESD build up in working area.
  • The Pinnacle Compounder should only be serviced by service personnel trained and authorized by B. Braun Medical Inc.
  • Before making any cable connection, look at the pins on either side of the connection.  Ensure that one half of the connection consists of cable pins and the other half of the connection consists of a mating receptacle.  Ensure that the connection has been lined up properly.  If care is not exercised in ensuring the connection is lined up correctly or is correctly mated, you will break off the pins and will not be able to run the system.
  • Exit the Pinnacle Compounder program prior to power off or unplugging your Control Panel.  Otherwise information may not be saved or possible damage to the data files may occur.
  • When used with the Pinnacle Compounder:
    • The Pinnacle Compounder may have been damaged during shipping and handling.  Do not use the Control Panel or Pump Module if it appears physically damaged, fails its self test, or displays any unrecoverable error messages, as patient injury or device damage may occur.
    • It is recommended that the Pinnacle Compounder only be used with B. Braun supplied Final Containers, Transfer Sets, and associated B. Braun components.  It is the responsibility of the User to ensure other non-B. Braun Final Containers and associated components, when used, function in accordance with product specifications.
    • To maximize the delivery accuracy of the Pinnacle Compounder:
      • When using B. Braun supplied Final Containers, identify on the Main Programming screen the size and type of container being used.  The Pinnacle Compounder will then automatically apply corresponding additional fill controls that further enhance system delivery accuracy.
      • Suspend Final Containers from the Pinnacle Compounder Load Cell in accordance with the instructions provided.
      • Attach Final Containers to the Pinnacle Compounder Transfer Set Manifold in accordance with the instructions provided.
    • When utilizing both large and small source solution volumes as components in a formula to be compounded, for delivery accuracy in accordance with Pinnacle Compounder specifications, stations with larger programmed volumes should be delivered/compounded prior to delivering stations with smaller programmed volumes.
    • When utilized as a component in a formula to be compounded, Sterile Water for Injection should be utilized as the last solution to be added/compounded.
    • Following movement or significant jostling of the Pinnacle Compounder Pump Module, the User should perform a calibration of the load cell.
    • Should the “no weight” reading of the load cell at any time exceed +/- five (5) grams, the User should perform a calibration of the load cell.
    • It is recommended that the 1000 gram weight provided by B. Braun be used for calibration to ensure that the device calibration accuracy is adequate for delivery within the device specifications.  A generic 1000 gram weight should not be used.
    • The Pinnacle Compounder should only be used on a level surface.
    • Due to the nature of silicone tubing, particulate matter is generated from within the mechanical area of the Pinnacle Compounder Pump Module and residual particulates may be observed inside the cover.  Proper cleaning and aseptic technique should be followed, in accordance with institutional guidelines.
    • Do not use the Load Cell or Load Cell Arm when lifting and moving the Pinnacle Compounder Pump Module.  To protect the User and prevent damage to the Compounder, the User should use the handles built into the Compounder ends.
    • The lithium battery contained in the Pinnacle Compounder Pump Module should only be replaced by trained and authorized service personnel.
    • Pharmacy aseptic technique should be used at all times and any connections, whether set, solution, bag, etc., shall be made directly in line of the clean hood airflow.  No connections shall be made if an object is obstructing the clean hood airflow.

CAUTION - USER’S FAILURE TO VERIFY THE VALUES, CALCULATIONS, AND OTHER INFORMATION USED IN COMPOUNDING COULD CAUSE INJURY TO THE PATIENT
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