H12+ Service Manual Rev B1

®

Copyright© 2018 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. H12+ is a trademark of Mortara Instrument, Inc.

Technical Support and Service Following are telephone numbers and addresses for contacting various technical support and service personnel.

Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

European Union Representative Mortara Instrument Europe, s.r.l. (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected] 24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Hospital Customers: [email protected] Physician Practice: [email protected] U.S. Distribution: [email protected] Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478 Mortara Dolby UK Ltd.

Units 11 & 12, Scion House Stirling University Innovation Park Stirling FK9 4NF Scotland Tel: +44.1786.444980 Fax: +44.1786.446630

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Notices Manufacturer’s Responsibility Mortara Instrument, Inc., is responsible for the effects on safety and performance only if Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Mortara Instrument, The electrical installation of the relevant room complies with the requirements of appropriate regulations, and The H12+ Holter Recorder is used in accordance with the instructions for use. Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument equipment is identified by serial numbers on the back or bottom of the device. Care should be taken so that these numbers are not defaced. Information pertinent to tracking and manufacturing is found on the product and may be called upon if service of the device is required. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of Mortara Instrument, Inc. The information contained in this document is subject to change without notice. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc., makes no warranty of any kind with regard to this material, including, but not limited to implied warranties of merchant ability and fitness for a particular purpose. Mortara Instrument, Inc., assumes no responsibility for any errors of omission in this document. Mortara Instrument makes no commitment to update nor to keep current the information contained in this document.

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Warranty Information MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara. Normal use, service and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions: a)

Freight damage;

b) Parts and/or accessories of the Products not obtained from or approved by Mortara; c)

Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides;

d) Accident, a disaster affecting the Products; e)

Alterations or modifications to the Products not authorized by Mortara;

f)

Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Products (i) of all carrier charges with respect to any Products returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Products. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm or damage, or the original purchase price of the Product when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANT ABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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User Safety Information Note:

Provides information to further assist in the use of the device.

Equipment Symbols Symbol Delineation

CAUTION:

Means there is the possibility of damage to the equipment.

Anti-Static equipment should always be worn when working with static sensitive devices and in a static sensitive area.

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Table of Contents 1

General

Service Manual Purpose ... 1-1 User Safety Information ... 1-1 Periodic Safety Inspections ... 1-1 Do Not Mount Product above Patient ... 1-1 Proper patient Cable ... 1-1 Recommended Accessories ... 1-1 Sterilizing this Product... 1-1 Liquid Spills ... 1-1 Product Information ... 1-1 Equipment Symbols ... 1-2 Symbol Delineation ... 1-2

2

Maintenance and Cleaning

Introduction ... 2-1 Recommended Cleaning Supplies ... 2-1 Cleaning and Inspection Techniques ... 2-1 Metallic and Plastic Parts Cleaning ... 2-2 Exterior Cleaning ... 2-2 Interior Visual Inspection ... 2-2 Preventive Maintenance Schedule ... 2-2 Batteries Removal / Installation ... 2-3

3

Technical Description

H12+ Overview ... 3-1 Opening and Closing the Battery Door ... 3-2 Inserting and Removing Flash Cards ... 3-3 Inserting the Battery... 3-3 Attaching the Patient Cable ... 3-4 Using the Keypad ... 3-5 Main Menu Options ... 3-5 Lead Check ... 3-7 Display ECG Leads ... 3-8 Enter ID ... 3-8 Configuring Date/Time and Language ... 3-9 Setting Date and Time ...3-11 Setting Language ...3-11 Viewing Software Version Number ...3-12 Starting a Recording Session ...3-12 Entering (Optional) Diary Events ...3-13 Ending a Recording Session ...3-13

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4

H12+ Disassembly

Parts List ...4-1 Opening the Unit ...4-2 Keypad Removal ...4-4 LCD Removal & Replacement ...4-5 Digital Board Removal & Replacement ...4-7 Front End Board Removal & Replacement ...4-8

5

Printed Circuit Boards

Introduction ...5-1 Flow Chart ...5-1 H12+ Front End PC Board Assembly ...5-2 H12+ Front End Block Diagram ...5-4 H12+ Digital PC Board Assembly ...5-5 H12+ Digital Board Block Diagram ...5-7

6

Testing and Troubleshooting

Introduction ...6-1 Warning ...6-1 Conformance Test ...6-1 Safety Test ...6-6 Required Safety Test for Printed Circuit Boards...6-8 Troubleshooting ...6-8

7

Log File Information

Introduction ...7-1 Power Up Section ... 7-1 Mode Section ... 7-2 Fault Section ... 7-3

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Section 1

1

General

Service Manual Purpose The purpose of this manual is to provide information to service personnel in order to maintain the H12+ Holter Recorder. This manual includes parts lists and is intended to function primarily as a guide to preventative and corrective maintenance and electrical repairs considered field repairable. WARNING:

No user serviceable parts are inside. Any modification of this device will void any and all Manufacturer's Warranties and/or responsibilities. If you are not able to correct the H12+ Holter Recorder’s questionable operating state using the Troubleshooting guide in the Operator's Manual, do not attempt to service it yourself. Contact Mortara Service at 1-888MORTARA (667-8272).

User Safety Information Periodic Safety Inspections Follow the recommended maintenance schedule. Inspect the patient cable(s) periodically for fraying or other damage and replace as needed. Broken or frayed wires may cause interference or loss of signal. Pay particular attention to points where wires enter connectors.

Do Not Mount Product above Patient Do not mount or place the product where it could fall on a patient or where it could be accidentally knocked off a shelf or other mounting arrangement.

Proper Patient Cable Use only the patient cable specified for this unit.

Recommended Accessories For the patient's safety and optimum equipment performance, use only the accessories specified by/or that meet Mortara Instrument, Inc. specifications.

Sterilizing this Product Do not sterilize this product or any accessories unless specifically directed by the manufacturer. Sterilization and sterilization environments can seriously damage many components and accessories.

Liquid Spills Do not set beverages or other liquids on or near the H12+, and/or optional equipment.

Product Information See Section 3 of this manual

1-1

H12+

Equipment Symbols Symbol Delineation

Electrostatic sensitive devices

1-2

Section 2

2

Maintenance and Cleaning

Introduction This section provides servicing and maintenance instructions for the H12+ Holter Recorder. Subsequent parts of this section are disassembly, inspection techniques, and cleaning techniques.

Recommended Interior Cleaning Supplies  Anti-static mat & wrist band, properly grounded  Clean, lint-free cloth  Cleaning solvent (isopropyl alcohol, 99% pure)  DRY, low pressure, compressed air (30 psi) Note: The equipment and solvent mentioned above are standard shop commodities that are available from commercial sources.

Cleaning and Inspecting Techniques: This section contains instructions for periodic cleaning and inspection of the instrument as preventative maintenance measures. It also contains specific cleaning procedures to be conducted. Parts having identical cleaning procedures are grouped under common headings. No special tools are required.

WARNING Ventilate work area thoroughly when using solvents. Observe manufacturers warnings on solvent containers with regard to personnel safety and emergency first aid. Be sure that first aid equipment is available before using chemicals. Observe shop safety and fire precautions. Ventilate all work areas where solvents are used. Store solvents and solvent-soaked rags in approved containers. Refer to manufacturers’ instructions on containers for recommended fire-fighting procedures, and make sure that fire-fighting equipment is available.

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H12+

Metallic and Plastic Parts Cleaning

CAUTION Do not wipe over surfaces of nameplates or labels with abrasive cleaners or materials, as this will eventually wear away the nameplate information. Do not use solvents to clean plastic parts.

Exterior Cleaning Use a damp cloth to clean external covers and the patient cable. Do not use alcohol, solvents, or cleaning solutions. These cleaning agents may damage the surfaces of the instrument.

Interior Visual Inspection Check all connectors for loose, bent or corroded contact points Check wire, harnesses and cables for signs of wear or deterioration. Inspect leads for security of mounting, or deterioration. Check terminals and connections for proper installation, loss or wear. Check the identification nameplate and other decals for legibility. Inspect chassis and covers for warping, bending, surface damage or missing captive hardware. Check all screws and nuts for tightness or signs of stripped or crossed threads. Check for any other form of mechanical damage, which may indicate a failure.

Preventative Maintenance Schedule: Maintenance to be Performed Clean and inspect unit.

2-2

Period 6 mo.

Notes Perform every 3 mo. if unit is in heavy use.

Section 2

Battery Removal / Installation: Remove the battery door. Remove the Battery. Check battery connection terminals for debris and/or corrosion.

CAUTION Be sure that the polarity of the batteries is correct. Follow diagram in cover. Use only Mortara approved Alkaline replacement batteries (Mortara part #4800-001). Re-install the batteries.

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H12+

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Section 3

3

Technical Description

H12+ Overview Instrument Type:

12-lead ECG Holter Recorder

Input channels:

Simultaneous acquisition of all leads.

Standard leads acquired:

I,II,III,aVR, aVL, aVF, V1, V2, V3, V4, V5, & V6

Input impedance

Meets or exceeds the requirements of ANSI / AAMI EC38

Input Dynamic Range Electrode Offset Tolerance Frequency Response Digital Sampling:

10,000 s/sec/channel used for pacemaker spike detection. 180 s/sec/channel for recording and analysis.

Special Functions

Pacemaker Detection, ECG Display, Lead Quality Check

A/D Conversion

20 bit

Storage:

Compact Flash Memory

Device Classification

Type CF, Battery operated

Weight:

4 Ounces (125g) without batteries

Dimensions (HxWxD):

2.5 x 3.5 x 0.98 Inches (64 x 91 x 25 mm)

Batteries:

1 AA alkaline required

3-1

H12+

H12+ Digital Recorder The compact flash card slot and the battery compartment are accessible via the battery door of the H12+ Recorder.

Opening and Closing the Battery Door To open the battery door, hold the latch (1) down and then depress and slide the battery door (2) until it stops.

2

1

Lift and remove the battery door.

To close the battery door, place the battery door on the H12+ as shown above and slide the door in the opposite direction of the arrow (2) until the door snaps into place. It is recommended that latch (1) be depressed when closing the battery door to prevent damage to the door and the latch assembly.

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Section 3

Inserting and Removing Flash Cards To insert or remove a flash card, open the battery door of the H12+. Locate the card slot and the Eject button located to the right of the card slot on the inside of the H12+. Note: The Eject button has two positions: Up (card properly inserted) and Down (card ejected). To insert a flash card in an empty card slot, position the card above the card slot with the arrow on the card pointing down. Place the flash card in the card slot and gently push down on the card until it stops. To complete insertion, push down on the top of the card until the Eject button pops up to the full-upright position.

To remove a flash card from the card slot, depress the Eject button. When fully depressed, the top of the Eject button is flush with the opening of the card slot. Once ejected, grasp the top of the card and lift it out of the card slot.

Inserting the Battery The H12+ Recorder is powered with a single AA alkaline battery. To insert a new battery into the battery compartment, open the battery door of the H12+. If a battery is present in the compartment, remove and discard the battery. Insert a new battery with the ‘+’ end aligned with the top of the recorder, as indicated on the back label. Close the battery door of the recorder. Note: The H12+ recorder requires a fully-charged battery to record a 24-hour session. If you are not clear as to the status of a battery’s voltage, use a new battery to insure operation for 24 hours.

3-3

H12+

Attaching the Patient Cable The LeadForm Patient Cable consists of a connector block, main cable and ten leadwires connected to the main cable. Each leadwire terminates in a snap connector. The leadwires are positioned on the main cable to follow the contour of the torso.

Insert the connector block into the input connector on the side of the H12+. Note: Be careful to insert the connector block parallel to the input connector of the H12+.

Connector Block

Input Connector

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Section 3

Using the Keypad The keypad is located on the front, right-side of the H12+ Recorder. Three keys are available for navigating through the LCD screens and for entering the patient ID and event markers during the recording. These include the Up/Right, Down and Enter keys.

Up/Right V1

Down

Enter

During patient hook-up, the Down and Up keys are used to scroll through the Main menu options, to enter the Patient ID and to set the date/time and language. The Enter key is used to select a Main menu option and submenus displayed on the LCD screen and to store the patient ID and configuration parameters for recorder operation.

Main Menu Options The Main, or top-level, menu includes the following options.     

LEAD CHECK DISPLAY ECG ENTER ID RECORD CONFIGURE

On the next page, an operational flowchart of Main menu options depicts the flow of functionality using the Up, Down and Enter keys.

3-5

H12+

The LEAD CHECK, DISPLAY ECG, ENTER ID and CONFIGURE tasks are performed prior to starting a new patient recording. With the exception of CONFIGURE, the other three tasks typically are done for each new recording. Note: Patient ID entry (ENTER ID) is optional. If desired, the patient ID may be entered after the patient record is downloaded to the H-Scribe system.

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