Spacelabs Healthcare Eclipse PRO - User Manual

Eclipse
PRO
™
Model 98700
Sensor Application Guide
Ambulatory ECG and Patch Recorder
For the Clinician
1 2 3
Congure the recorder for the paent.
See the Eclipse PRO User's Manual for
further informaon.
Also complete the paent informaon
page in the Paent Diary being supplied
to the paent.
Remove patch electrode from outer
packaging (do not discard packaging) and
place face down on a at surface.
Open the patch pocket door, insert the
Recorder (face down) into the patch,
and connect the USB connector into the
recorder socket.
4
1
3a
3b
5 6
Remove the 1st release liner (3a) to
expose the pocket adhesive seal and
close the pocket door (3b).
Apply pressure over the back of the
patch to ensure a good seal. Place the
patch and recorder assembly back in the
outer packaging ready for shipping.
Press the right buon unl the recorder
displays the 'Recording' screen.
7
Package the assembled Sensor Patch along
with Part 2 of these instrucons, and a
Paent Diary (enter paent and contact
details on page 3), and ship to the paent.
The following instrucons are divided into two parts. The rst part are instrucons for the clinician when preparing an Eclipse PRO recorder
for shipment to a paent who will be self applying the recorder patch. The second part is instrucons for the paent as to how to apply the
patch, and should accompany the recorder when sent to the paent.
Items to supply to paent:
1. Eclipse PRO Recorder - congured and ed into Sensor Patch
2. Paent Diary
3. Part 2 of these instrucons.

Summary

Clinician Preparation and Shipment

Clinician Workflow Steps

Step-by-step instructions for clinicians to prepare the Eclipse PRO recorder and patch for patient shipment.

Eclipse PRO ECG Sensor Precautions

General Sensor Usage Warnings

Important safety and usage guidelines for the Eclipse PRO ECG Sensor, including single-use and disposal information.

Patient Self-Hook-Up Guide

Patient Application Steps

Instructions for patients on how to apply the Eclipse PRO Sensor Patch and record symptoms in the Patient Diary.

Patient Precautions and Support

Patient Care and Activity Guidance

Guidance for patients regarding showering, activity avoidance, and seeking help for questions or problems.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
   1. For Clinicians
   2. For Patients (Self-Hook-Up)
4. Maintenance Features
   1. Disposal
   2. Skin Care
   3. Device Integrity
   4. Defibrillation
   5. Extended Recording

The Spacelabs Healthcare Eclipse PRO Ambulatory ECG and Patch Recorder, Model 98700, is a medical device designed for extended cardiac monitoring. It is intended for use with either pediatric patients (weighing over 10 kg) or adult patients suspected of cardiac arrhythmias, in both clinical and home settings.

Function Description

The Eclipse PRO system consists of an ambulatory ECG recorder and a disposable Sensor Patch. The recorder captures the electrical patterns of the heart, providing an Ambulatory ECG recording. The Sensor Patch, which houses the recorder, is applied to the patient's chest and automatically initiates recording once it detects the heart rhythm. This allows for continuous monitoring of cardiac activity over an extended period. The system is designed to be water-resistant, allowing patients to shower while wearing it, though excessive water exposure should be minimized.

Important Technical Specifications

The Eclipse PRO ECG Sensor is a single-use, disposable device. It is constructed from an adhesive, spunlace, nonwoven medical tape, supporting four multilayer, sensing ECG hydrogel electrodes. To optimize sensing capabilities, the sensor is available in one size: 195.5 mm by 90 mm. The recorder itself is pre-configured and fitted into the Sensor Patch prior to patient application. The device is not designed for use in proximity to high-frequency surgical equipment or near an MRI machine, and must be removed before treatments involving such equipment. No modification of the equipment is allowed.

Usage Features

For Clinicians:

1. Configuration and Assembly: Clinicians must configure the Eclipse PRO recorder for the patient according to the Eclipse PRO User's Manual.
2. Patient Information: Complete the patient information page in the Patient Diary.
3. Patch Preparation:
   • Remove the patch electrode from its outer packaging and place it face down on a flat surface.
   • Open the patch pocket door.
   • Insert the recorder (face down) into the patch.
   • Connect the USB connector into the recorder socket.
   • Remove the first release liner (3a) to expose the pocket adhesive seal.
   • Close the pocket door (3b).
   • Apply pressure over the back of the patch to ensure a good seal.
   • Press the right button on the recorder until it displays the 'Recording' screen.
4. Packaging for Shipment: Place the assembled patch and recorder back into the outer packaging. Package the assembled Sensor Patch, Part 2 of the instructions (for the patient), and a Patient Diary (with patient and contact details entered on page 3), then ship to the patient.

For Patients (Self-Hook-Up):

1. Preparation: The patient receives a pre-configured Eclipse PRO Recorder fitted into a Sensor Patch, a Patient Diary, and patient instructions.
2. Application: The recording starts automatically once the patch is applied to the chest and picks up the heart rhythm.
3. Water Resistance: The Sensor Patch Electrode is water-resistant, allowing for showering, but not bathing. Patients should minimize water exposure to the patch and gently pat it dry with a towel after showering.
4. Activity Restrictions: Patients should avoid activities that cause excessive sweating, as this may cause the patch or electrodes to detach.
5. Symptom Recording: Patients are instructed to record any symptoms experienced during daily activities in the provided Patient Diary. For each event, the activity being performed at that time should be noted. Patients can also press either button on the recorder to mark an event and then make an entry in the diary.
6. Support: For questions or problems, patients should contact the hospital or caregiver using the details provided in the Patient Diary.

Maintenance Features

Disposal:

The Eclipse PRO ECG Sensor is a single-use, disposable device. After use, it must be treated as bio-hazard waste and disposed of according to local waste disposal regulations.

Skin Care:

Prolonged wear of the Eclipse PRO ECG Sensor may cause temporary itchiness, irritation, or redness of the skin. It is contraindicated for patients with known allergic reactions or hypersensitivity to adhesives or hydrogels. The sensor may not be suitable for patients with sensitive or fragile skin. The use of appropriate medical adhesive removal wipes can help reduce skin irritation post-removal.

Device Integrity:

• The Eclipse PRO ECG Sensor or the Eclipse PRO recorder should not get excessively wet.
• Never attempt to connect any other device or instrument to the internal connections or circuitry of the Eclipse PRO recorder while it is connected to a patient.
• The electrodes of the Eclipse PRO ECG Sensor must not be allowed to contact other conductive parts, even if they are at ground potential.

Defibrillation:

If defibrillation is required, the Eclipse PRO ECG Sensor must be removed prior to de-fibrillating a patient, as its presence may reduce the effectiveness of the defibrillator.

Extended Recording:

For extended recording periods, multiple Eclipse PRO ECG Sensors might be required, implying a need for replacement of the disposable sensor.

Spacelabs Healthcare Eclipse PRO Specifications

General

Brand	Spacelabs Healthcare
Model	Eclipse PRO
Category	Medical Equipment
Language	English