HAMILTON-MR1 Installation Guide

Manufacturer Information

Hamilton Medical AG
Via Crusch 8
CH-7402 Bonaduz
Switzerland
Phone: (+41) 58 610 10 20
Email: info@hamilton-medical.com
Website: www.hamilton-medical.com

Copyright © 2021 Hamilton Medical AG. All rights reserved. Printed in Switzerland.

No part of this publication may be reproduced, stored in a database or retrieval system, or transmitted in any form or by any means, electronic, mechanical, or by photocopying, recording, or otherwise, without prior written permission of Hamilton Medical AG.

This document may be revised, replaced, or made obsolete by other documents by Hamilton Medical AG at any time and without notice. Ensure that you have the most current applicable version of this document; if in doubt, contact the technical support department of Hamilton Medical AG, Switzerland. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment.

Hamilton Medical AG reserves the right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Hamilton Medical AG has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including software) described herein.

The equipment must be operated, serviced, or upgraded only by trained professionals. Hamilton Medical AG's sole responsibility with respect to the equipment and its use is as stated in the limited warranty provided in the operator's manual.

Hamilton Medical AG shall not be liable for any loss, cost, expense, inconvenience, or damage that may arise out of misuse of the product, or if non-Hamilton Medical AG parts were used when replacing parts, or if serial numbers were amended, deleted, or removed.

If returning parts to Hamilton Medical AG, use the standard Hamilton Medical returned goods authorization (RGA) procedure. Disposal of parts shall follow all local, state, and federal regulations with respect to environmental protection.

Product and company names mentioned herein may be the trademarks and/or registered trademarks of their respective owners.

Hamilton Medical AG will make available, on request, circuit diagrams, component parts lists, descriptions, calibration instructions, or other information that will assist appropriately trained personnel to repair those parts of the equipment designated by Hamilton Medical AG to be repairable.

1. Document History

2. Notes, Cautions, and Warnings

Safety messages are displayed as follows:

A WARNING alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.

A CAUTION alerts the user to the possibility of a problem with the device associated with its use or misuse, such as device malfunction, device failure, damage to the device, or damage to other property.

A NOTICE emphasizes information of particular importance. For additional information, see the System Overview Chapter of the HAMILTON-MR1 Operator's Manual (PN 10101887).

3. Introduction

This guide describes how to set up the HAMILTON-MR1 ventilator and prepare it for operation. This includes instructions to install all its main components and optional accessories.

If you have questions, contact your Hamilton Medical technical support representative or write to techsupport@hamilton-medical.com.

Depending on the ordered configuration, some parts may not be available or already be installed on the ventilator.

4. Installation Requirements

Service engineers/technicians responsible for the installation must comply or fulfill the following requirements:

• Only trained service engineers authorized by Hamilton Medical are allowed to service, maintain, install, and replace parts/components of the ventilator.
• Always return defective parts, components, or assemblies to Hamilton Medical AG, Switzerland, with a completed Return Good Authorization (RGA) request.

5. Delivered Parts and Accessories

5.1. Required Parts

5.2. Basic Accessories

5.3. Optional Accessories

6. Packaging

Image: Packaging overview showing the HAMILTON-MR1 ventilator and accessories in an open cardboard box with protective foam.

• Store the original packaging, including the protective material for later use. This will protect the equipment if you have to move it.
• Breathing set not included for all countries.

7. Installing the Oxygen Connector

For 1610100 devices, the DISS or NIST oxygen connector is preassembled during production.

1. Remove the yellow protective cap (2) from the high-pressure oxygen inlet.
2. Use a Torx TX 10 screwdriver to remove the two screws (1).

Figure 7-1: Close-up view of the rear of the HAMILTON-MR1 ventilator, showing the high-pressure oxygen inlet with a yellow protective cap labeled '2' and two screw holes labeled '1'.

3. Position the DISS or NIST connector (3) in its housing and push it in position.

• Make sure the two holes for the screws in the connector (3) match the ones in the ventilator. Use the figure below as a reference.
• Make sure the connector (3) is correctly placed and fully inserted in its housing. For additional information, see the Oxygen Connectors Set Installation Guide (PN 612219).

4. Install the two screws (1). Use a Torx TX 10 screwdriver to tighten the two screws (1).

Figure 7-2: Close-up view of the rear of the HAMILTON-MR1 ventilator, showing the DISS/NIST oxygen connector labeled '3' being inserted into its housing.

8. Installing the O2 Sensor

1. Use a Torx TX 20 screwdriver to remove the seven screws (2) shown in the figure below.
2. Remove the filter cover (1).

Figure 8-1: Close-up view of the rear of the HAMILTON-MR1 ventilator, showing the filter cover labeled '1' and seven screws labeled '2'.

3. Check the presence of the O2 sensor (5).

Do not switch on the ventilator if the O2 sensor (5) is not correctly installed. Contact Hamilton Medical for assistance.

• If the O2 sensor (5) is already mounted to the ventilator, remove the cell plug (4) and check that the O2 sensor (5) is tightly mounted into its housing. In case of movement, tighten the O2 sensor (5) by turning it clockwise.
• Afterwards, reconnect the cell plug (4), reinstall the filter cover (1) and secure it in position with the screw (2).

Figure 8-2: Close-up view of the O2 sensor housing with a yellow protective cap labeled '3' removed.

5. Align the O2 sensor (5) with the screw thread in the housing. Then, turn the O2 sensor (5) clockwise to tighten it.
6. Insert the cell plug (4) into the O2 sensor (5).

Figure 8-3: Close-up view of the O2 sensor housing showing the O2 sensor labeled '5' and the cell plug labeled '4' being inserted.

Do not attach the filter cover yet. Check the batteries first.

9. Connecting the Power Sources

Before proceeding with the installation, see the Connecting to a power source Chapter of the HAMILTON-MR1 Operator's Manual (PN 10101887).

9.1. Checking the Batteries

• The two batteries are preassembled during production.
• The HAMILTON-MR1 ventilator is a class I device according to IEC 60601-1. Therefore, it requires protective earth grounding.
• Before installing the ventilator, always check the reliability of the AC power source.

1. Check that both batteries (1) are correctly installed and fully inserted.

Figure 9-1: Close-up view of the ventilator interior showing two battery compartments, each with a battery labeled '1'.

2. Attach the filter cover removed earlier. Use a Torx TX 20 screwdriver to reinstall the seven screws to secure the filter cover to the ventilator.

9.2. Connecting to AC Power

• The primary power supply for the HAMILTON-MR1 ventilator is AC between 100 and 240 V and between 50 and 60 Hz.
• Before installing the ventilator, check the location of the AC plugs and make sure to have enough free space to easily disconnect the power supply whenever needed.
• To avoid unintentional disconnections, always secure the AC power cord with the provided cable clamp.

1. Connect the DC power cord (2) from the power supply to the ventilator and secure it using the knurled ring (1) on the power cord connector.

Figure 9-3: Close-up view of the ventilator's power connector area, showing a knurled ring labeled '1' and a DC power cord labeled '2'.

2. Connect the AC power cable from the power supply to a suitable AC power supply.
3. After switching on the ventilator, the power symbol (3) will be displayed in the bottom right corner of the screen.

Figure 9-4: Screenshot of the HAMILTON-MR1 ventilator's touchscreen display. It shows various patient data (Modes, O2 sensor status, ventilation parameters like PEEP, Tidal Volume, Oxygen percentage, Patient Height, IBW) and status indicators (Standby mode, Power symbol).

10. Switching on the TeslaSpy

Always switch on the TeslaSpy before switching on the ventilator.

1. The TeslaSpy switch (1) is located on the underside of the MR1 ventilator. Use a pen or any other thin object to gently push the switch (1) and activate the TeslaSpy.

Figure 10-1: Underside view of the HAMILTON-MR1 ventilator, highlighting the TeslaSpy switch labeled '1'.

2. When the TeslaSpy is active, the green LED (2) on the front panel flashes.

Figure 10-2: Front panel of the HAMILTON-MR1 ventilator, showing the "HAMILTON-MR1" logo, "MR" symbol, and the TeslaSpy indicator with a green LED labeled '2' flashing.

11. Attaching the Icons

11.1. Feature Icons

1. Attach the feature icons positioning guide (2) to the front left corner of the ventilator.
2. Attach the required feature icons (1) to the ventilator in the spaces marked by the feature icons positioning guide (2).
3. Remove and discard the feature icons positioning guide (2).

Figure 10-1: Front left corner of the HAMILTON-MR1 ventilator. It shows a light blue feature icons positioning guide labeled '2' placed on the device, with feature icons labeled '1' being attached to the indicated positions.

12. Testing and Acceptance

12.1. Device Information

Fill in the following details for the HAMILTON-MR1:

12.2. Component Installation Checks

12.3. General Checks

If the HAMILTON-MR1 ventilator does not pass the initial installation tests and checks, contact your local Hamilton Medical representative or Hamilton Medical's technical support for assistance.

After you have completed the Initial Installation Testing and Acceptance Report for the HAMILTON-MR1 ventilator, please send a copy of the report to your local Hamilton Medical representative or Hamilton Medical (techsupport@hamilton-medical.com), and save/archive the original report for your records.

Remarks:

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Date (YYYY/MM/DD): ___________ / ____ / ____ Signature: ____________________