Eitan Sapphire Multi-Therapy - User Manual

Intended use, delivery routes, and types of solutions the pump can deliver.

How pump types are preconfigured for specific delivery modes for safety and convenience.

Key features designed to simplify treatment and ensure patient safety.

Overview of labeling, safety, and compliance information.

Important safety information and precautions for operating the Sapphire pump.

Items included with the Sapphire pump and steps for inspection.

Identification and description of the pump's hardware and software components.

Explanation of the pump's touch screen areas and their functions.

Instructions on setting up various pump accessories like cradles and lockboxes.

Purpose and workflow for using PCA Lockboxes of different capacities.

Functionality and connection of the remote bolus handle for patient-controlled boluses.

Specifications and charging procedures for the pump's power supply.

Critical warnings and safety precautions for using the External Battery Pack (EBP).

System designed to facilitate the use of multiple pumps and provide power consolidation.

Information on using Q Core approved administration sets and alternatives.

List of administration sets approved by Q Core Medical Ltd. for use with the Sapphire pump.

Explanation of the pump's main display, its function as a work area, and its components.

Details on using the numeric and alphanumeric keypads for data entry and navigation.

Explanation of function keys in the toolbar and their actions on different screens.

Description of frequently appearing icons on the Indicators Bar and Main Display.

Explanation of different delivery modes the pump can operate in and how to select them.

How to enable or disable special functions requiring an authorization code.

Recommended sequence of steps to prepare the pump and administration set for an infusion.

Procedure for powering on the Sapphire pump and system checks.

Steps for powering off the pump, including emergency shutdown.

Steps for connecting the infusion container to the administration set, including safety precautions.

Procedure for opening the pump's safety door to access the administration set.

Step-by-step instructions for inserting the Q Core administration cassette into the pump.

Procedure for safely removing the Q Core administration cassette from the pump.

Procedure for priming the administration set using the pump's automatic function.

Instructions for manually priming the administration set using gravity or the AFFV.

Operating the pump in Continuous Mode, including parameters and mid-infusion actions.

Operating the pump in Multi-step Mode, including parameters and mid-infusion actions.

Operating the pump in TPN Mode, including parameters and mid-infusion actions.

Operating the pump in Intermittent Mode, including parameters and mid-infusion actions.

Operating the pump in PCA Mode, including parameters and mid-infusion actions.

Operating the pump in Epidural Mode, including PCEA and Epidural Intermittent sub-modes.

Shortcut operations to begin an infusion without re-entering parameters.

Procedure for resuming an infusion after the pump has been turned off.

Common procedures performed during an infusion, such as pausing or aborting.

Overview of the Options screen for accessing configurable pump settings, testing, and system data.

How to change the pump's delivery mode using the Options menu.

Viewing and updating pump configuration settings like alarms and audio.

Testing basic system functionalities of the pump, accessible by High or Technician users.

Accessing current pump settings and lists of audited events.

Viewing current system settings and infusion parameters, and updating selected settings.

Viewing a record of all events audited by the system, by date or all events.

Summary of medication delivery and bolus events for PCA, PCEA, and PIEB modes.

Viewing and updating PCA-specific parameters like bolus rate and infusion type.

Setting authorization levels to control access to pump programming options.

Requirement to re-enter password for specific actions to prevent inadvertent changes.

Creating, editing, and deleting infusion programs with predefined parameters.

Programming an infusion to start in advance or to set it to Standby.

Associating infusions with a specific patient to track data.

Monitoring the cumulative volume infused for a specific patient.

Information about customized drug groups and Clinical Care Areas (CCAs) for safer practice.

Information about CCAs, drug profiles, and their accommodation capacity.

Procedures for selecting or changing the CCA, and how it applies during operation.

Steps for programming infusions using the Drug Library, including drug name entry and profile selection.

Understanding soft limits and how the pump alerts users to exceed recommended parameter ranges.

Description of different types of alarms and their effects on the infusion.

Highest severity alarm category where the pump shuts down and infusion stops.

High severity alarm category where infusion stops and requires technician reactivation.

Medium severity alarm category requiring attention; infusion stops but may be resumed.

Indicates medium severity conditions requiring attention; infusion continues.

Common programming issues and solutions for the Sapphire pump.

Procedures for cleaning and disinfecting the pump and its components.

Procedures for cleaning and disinfecting the pump for single patient, multiple use.

Guidelines for routine inspection, maintenance tasks, and alarm testing.

Information on battery charge levels, operation time, and replacement recommendations.

Procedure for charging the pump's battery before initial use and during storage.

Procedures to promote maximum battery life through regular maintenance.

Conditions and guidelines for transporting and storing the pump and its components.

Graphs and conditions for testing pump accuracy according to IEC standards.

Detailed table listing pump dimensions, weight, mechanism, modes, KVO rate, accuracy, etc.

Graphs representing startup flow, stability, and flow rate deviation over time.

Operating and storage conditions related to temperature, humidity, and pressure.

Information about testing and recommendations for electromagnetic emission and immunity.

Specifies that the warranty extends only to the Initial Buyer of the Sapphire.

Procedure for making a defect claim, including contact information and return authorization.

Conditions that void the warranty, such as unauthorized repair or misuse.

Exclusions, disclaimers, and limitations of the manufacturer's warranty obligations.

Guidelines for service and repair, including return authorization and packing instructions.

Contact information for technical assistance and support.