MiraQ System User Manual SMMQUSen 3.1 .1

3.10

Cable hooks and power cable... 29

5.5

Connecting probes... 39

3.11

Lockable wheels... 29

5.6

TTFM Probe and System functionality test... 40

5.7

Defining measurement location... 42

4.

DELIVERY AND CONFIGURATION... 31

4.1

Delivery... 31

4.1.1

Receiving the M ­ edistim ­MiraQ™ ­System... 31

4.1.2

Unpacking and packing... 31

4.2

System Verification... 31

4.2.1

Verifying system identity... 31

4.2.2

Verifying electrical safety... 31

4.3

Initial configuration... 31

4.3.1

Basic software configuration... 32

4.4

Pay-Per-Procedure licensing... 32

4.4.1

Pay-Per-Procedure statistics... 33

5.

OPERATING THE MEDISTIM MiraQ™ SYSTEM... 35

5.1

Preparations... 35

5.2

Startup... 36

5.2.1

Starting the system... 36

5.8

Performing live measurements... 43

5.8.1

Activating and deactivating input channels... 43

5.8.2

Adjusting volume... 43

5.8.3

Adjusting flow curves and Doppler displays... 43

5.8.4

Probe and measurement properties... 44

5.9

Saving measurements... 44

5.10

Memory scroll and trace review... 44

5.11

Review of recorded data... 45

5.12

Creating and viewing case reports... 47

5.12.1

Tasks after operation by surgeon... 47

5.13

Shutting down the system... 47

5.14

Cleaning, disinfection and sterilization... 47

5.14.1

System... 47

5.14.2

Probes... 47

6.

MEASUREMENT TYPES... 48

5.2.2

Selecting application... 36

6.1

Transit time flow measurement (TTFM)... 48

5.3

Patient data... 37

6.1.1

The TTFM principle... 48

5.3.1

Entering patient data... 37

6.1.2

Tasks during procedure by surgeon... 48

5.3.2

Retrieving patient data... 37

6.1.3

Tasks during procedure by operator... 49

5.3.3

Accessing patient data using DICOM... 38

6.2

Doppler measurement... 49

5.4

Selecting workflow... 38

6.2.1

The Doppler principle... 49

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Region of interest (ROI)... 64

6.2.2

Operation... 50

7.3.2

6.2.3

Tasks during procedure by operator... 50

7.3.3

Velocity Scale... 65

6.2.4

Performing vessel search... 51

7.3.4

Color control panel... 66

6.2.5

Detect position and quantify a stenosis... 51

7.3.5

Color Flow tips... 67

6.3

Pressure inputs... 52

7.4

PW mode (Pulsed-Wave Doppler)... 68

6.3.1

Calibrating the pressure transducer... 52

7.4.1

PW tab... 68

6.4

Auxiliary inputs... 52

7.4.2

PW gate control... 68

6.4.1

Calibrating the AUX channel for ECG... 53

7.4.3

PW control panel... 70

6.4.2

Calibrating the AUX channel for pressure... 54

7.5

Playback... 70

6.5

Imaging Measurements... 54

7.6

Measurement and annotations... 71

7.6.1

Using the Annotations and Caliper tools... 71

7.6.2

Setting up custom tools... 72

7.

ULTRASOUND IMAGING... 55

7.1

General... 55

7.1.1

Imaging presets... 55

8.

UNDERSTANDING GUIDED WORKFLOWS... 73

7.1.2

Selecting mode... 56

8.1

What is a Guided Workflow?... 73

7.1.3

The Imaging Screen... 56

8.2

Live measurement with Workflow... 73

7.1.4

Auto-freeze... 59

8.3

Managing Workflows... 74

7.1.5

Imaging properties... 60

8.3.1

The Workflow editor... 75

7.1.6

Exposure and ultrasound statistics... 62

7.2

2D mode... 62

7.2.1

Spatial compound imaging... 63

7.2.2

2D tab... 63

7.2.3

9.

DATA MANAGEMENT... 77

9.1

Export and import data... 77

9.2

Safe removal of storage devices... 77

2D control panel... 63

10.

ADVANCED FEATURES... 78

7.3

Color mode... 64

10.1

Anatomical locations, grafts and attributes... 78

7.3.1

Color tab... 64

10.1.1

Managing components... 78

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10.1.2

Defining a new component... 79

11.7

Report Settings... 91

10.2

Measurement comparison... 80

11.8

Probe Report... 91

10.2.1

Selecting measurement sets to compare... 80

11.9

Manage Project... 91

10.2.2

Side-by-side display of two measurement sets... 81

11.10

Advanced System Functionality... 91

10.3

Advanced Doppler functions... 82

10.3.1

Doppler controls... 82

12.

TROUBLESHOOTING... 93

10.3.2

Optimizing display gain... 82

12.1

The Help Screen and User Manual... 93

10.3.3

Adjust sample volume... 83

12.2

Reporting an issue & creating a system log... 93

10.3.4

Change filter settings... 83

10.3.5

Tuning Doppler noise... 83

10.4

Derived traces... 85

10.4.1

Fast Fourier Transformation (FFT)... 86

10.5

Trend measurements... 86

12.3

Warning related to incorrect system shutdown... 93

12.4

Hardware detection on startup... 94

12.5

Printer management... 94

12.5.1

Paper loading... 94

12.5.2

Changing ink cartridge (Canon printers)... 94

12.6

Service of the M ­ edistim ­MiraQ™ S ­ ystem... 95

12.7

Basic troubleshooting... 95

10.5.1

Save, review and edit trend curves... 87

10.6

Measurement and analysis (M&A)... 87

10.7

Managing Imaging presets... 87

13.

MAINTENANCE... 98

10.8

Probe test mode... 89

13.1

Probe statistics... 98

11.

SYSTEM SETTINGS AND CONFIGURATION... 90

13.2

Cleaning and Regular Maintenance... 99

11.1

Hospital Specifications... 90

13.3

Software Maintenance mode... 100

13.4

Storage... 100

13.5

Disposal instructions... 100

11.2

Configuration pull-down menu... 90

11.3

Configuration checkboxes... 90

11.4

Software Customization... 90

14.

PROBE CLEANING, DISINFECTION & STERILIZATION. 101

11.5

Surgeon setup... 91

14.1

General... 101

11.6

Anatomical Location Setup... 91

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APPENDIX A.ACOUSTIC OUTPUT REPORT... 102

APPENDIX D.ICON DESCRIPTION... 120

A.1

Probe Description... 102

D.1

A.1.1

L15 High-frequency Ultrasound Imaging probe... 102

A.2

Safety guidelines... 102

A.3

Acoustic output EIMC... 103

A.3.1

L15 Acoustic Output - 2D Mode... 103

A.3.2

L15 Acoustic Output - Color Flow Mode... 103

A.3.3

L15 Acoustic Output - PW Doppler Mode... 104

A.4

Acoustic output EIMD... 104

A.4.1

L15 Acoustic Output - 2D Mode... 104

A.4.2

L15 Acoustic Output - Color Flow Mode... 105

A.4.3

L15 Acoustic Output - PW Doppler Mode... 105

Icon Description... 120

APPENDIX E.DICOM FUNCTIONALITY... 124 E.1

Introduction... 124

E.2

Configuring the DICOM functionality... 124

E.2.1

Configuring network settings... 124

E.2.2

Configuring a DICOM server... 125

E.2.3

Configuring the hospital servers... 126

E.3

Using the DICOM functionality... 126

E.3.1

Importing patient data from a worklist server... 126

E.3.2

Exporting recorded data to a DICOM server... 127

E.3.3

Export job queue... 128

APPENDIX B.PROBE APPLICATION OVERVIEW... 106

E.4

Offline use... 129

B.1

Probe application and size guide... 106

E.4.1

Worklist import... 129

B.2

List of Available Medistim Probes... 108

E.5

DICOM icon description... 129

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APPENDIX C.OVERVIEW OF ERROR MESSAGES... 110 C.1

Probe related error messages... 110

C.2

Imaging hardware related error messages... 112

C.3

Smart card related error messages... 114

C.4

Other error messages... 116

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1.

INTRODUCTION • www.medistim.com

1.1 Purpose The purpose of this user manual is to give a thorough description and guidance for use of the ­­Medistim ­MiraQ™ S ­ ystem.

• Service manual for MiraQ™

1.2 Contact information

• ‘Intraoperative Graft Patency Verification during Onand Off Pump Coronary Bypass Surgery’ by Hratch L. Karamanoukian, MD and Harry W. Donias, MD, Medistim ref. number MM117803.

For contact details of your local Medistim subsidiary or distributor, visit Medistim’s web page (www.medistim.com).

• ‘Intraoperative Graft Patency Verification in Cardiac and Vascular Surgery’, Giuseppe D’Ancona et al., ISBN 0-87993-488-3.

1.3 Scope This manual is applicable to all ­Medistim ­MiraQ™ ­System models and configurations. Available system models are:

For the requirements applicable to this document and the ­Medistim ­MiraQ™ S ­ ystem please refer to: • IEC 60601-1 3rd Edition • IEC 60601-2-37 • IEC 60601-1-6

• MiraQ™ Cardiac

1.4.2

• MiraQ™ Vascular • MiraQ™ Ultimate

Update of User Manual

1.4 Manual structure and use

In the incidence of additional modifications to the M ­ edistim ­MiraQ™ S ­ ystem, a revision of the User Manual will be made available by Medistim ASA.

1.4.1

1.4.3

Relevant books and documents

Please refer to the following relevant information in addition to this user manual:

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User Manual language options

The M ­ iraQ™ S ­ ystem User Manual is available in multiple languages and can be supplied upon request.

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1.4.4

Technical description

Term

Definitions

2D

Two-Dimensional

ACI

Acoustical Contact Indicator or Acoustical Coupling Index

ALIASING

Refers to the frequency wrap around that occurs when a continuous time signal has frequencies larger than half of the sampling rate.

DF

Diastolic Filling

Warning A warning describes clinical contraindications and possible damage to the device if the recommended instructions or recommendations are not followed. Please read and follow these warnings carefully. If Warnings and Notes are not taken into consideration, the manufacturer cannot be held liable for injury or damage caused by disregarding these precautions.

FR

Frame Rate

GUI

Graphical User Interface

ME System

Medical Electrical system

MI

Mechanical Index

MiraQ™

Brand name for the ­Medistim M ­ iraQ™ ­System

Note A Note contains important tips, recommendations and supplementary information intended to optimize the use of the system.

PI

Pulsatility Index

PRF

Pulse Repetition Frequency

PW-Doppler

Pulsed-Wave Doppler

TGC

Time Gain Compensation

TI

Thermal Index

TIS

Thermal Index for Soft tissue

A technical description of the ­Medistim ­MiraQ™ ­System can be found in the M ­ edistim ­MiraQ™ ­System Service Manual.

1.4.5

Warning statements and safety markings

This User Manual contains warnings and notes according to the following definitions:

1.5 Acronyms, abbreviations and definitions Table 1-1 lists the most common acronyms, abbreviations and definitions used throughout this User Manual:

Table 1-1 viations

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Description of commonly used acronyms and abbre-

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Term

Definitions

TTFM

Transit Time Flow Measurement

USB

Universal Serial Bus

Table 1-1 viations

1.5.1

Description of commonly used acronyms and abbre-

Overview of symbols

Below is an overview of all the symbols affixed to the ­Medistim ­MiraQ™ S ­ ystem with a short description of their meaning. Power button. No light = System has no AC connection / is not plugged in Green = System is active Blue = System is in standby mode

Catalogue number

This symbol is used to indicate a hazard. Consult the user manual before using this feature, important information on its use is explained there.

Manufacturer contact address

Serial number

Date of manufacture Defibrillator proof type CF applied part Please recycle. Read disposal instructions before discarding Potential equalization conductor terminal

Consult the user manual before using this feature, important information on its use is explained there

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CE mark - Conformitè Europèenne and Notified Body number

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Approved MET mark with manufacturer listing number USB port - See “3.7.3 USB port connections” and “9.2 Safe removal of storage devices” for information on proper use of the USB ports on the MiraQ™ System Network Port - Used for DICOM communication or data backup. See also “3.7.3 USB port connections”

Warning Potential Equalization conductor: A terminal for potential equalization is located at the back of the power unit of the system. The terminal can be used if potential equalization is needed but is no replacement for the protective earth conductor of the power chord as required by IEC60601-1 cl. 8.6.7.

Maximum total system weight Federal Law (USA) restricts this Device to sale by or on the order of a physician International Protection / Ingress protection rating

UL certification mark

INMETRO certification mark

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2.

INDICATIONS FOR USE

2.1 Indication for use statement

2.2 Intended patient groups

The Medistim MiraQ™ System is an intraoperative system that utilizes ultrasonography to visualize blood flow and guide surgeons to successfully plan and accomplish surgical interventions.

The Medistim MiraQ™ System is intended for use on adult and pediatric patients. For the contraindicated patient groups see the chapter for contraindications.

2.3 Contraindications

The clinical indications for the device are: Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation-, and neuro-surgery.

2.

Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.

3.

Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.

4.

Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.

5.

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Do not use this system for other applications than the intended use.

1.

Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.

The Medistim MiraQ™ System is not intended for any kind of fetal applications. Manipulation of vessels with thrombus, calcification or other conditions may have serious consequences for the patient, and represents a contraindication for the measurement of blood flow. Sound medical judgment should therefore be exercised and the final responsibility for measuring flow in diseased vessels lies with the physician. Avoid any pinching of vessels while conducting flow measurements. The Medistim MiraQ™ System and the associated imaging probe L15 is not intended for use in the following surgical applications: • Ophthalmic ultrasound and Doppler scanning • Cranial / transcranial ultrasound and Doppler scanning • Neonatal cephalic use

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2.4 Intended use The system is designed to perform intraoperative guidance and quality control during cardiovascular surgical procedures and meets the demands for documentation of surgical procedures. To successfully operate the system, at least two persons are required, one controlling the probe and the other controlling the system. See section “2.6 Intended user profiles & personnel requirements” for more information.

2.5 Operational requirements for use • • • • •

Correct electrical supply Proper grounding of system Indoor use only For intraoperative use only Environmental operating conditions including EMC according to Service manual

Warning Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the instructions provided in the service manual. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.

Note Essential performance related to measurement might be affected by electromagnetic disturbances. Due to the characteristics of the electromagnetic disturbances, the risk of misinterpretation of the physiological measurement will be negligible.

Warning Use of this equipment directly adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment should be observed to verify that they are operating normally. Note The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Warning Users should employ exposures which are as low as reasonably achievable (ALARA) because of the potential for ultrasonic heating of tissue during ultrasound blood flow examinations.

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2.5.1

Intended conditions for use

Description • Ambient temperature is normally slightly

Condition

Description

Physical

General

Normally the system will be placed in an area of the hospital with restricted access, either an operating room or a hospital office. The main system will be positioned in the operating room outside the sterile field, while the probes will be used within the sterile field.

Frequency of use

The frequency of use is from once a month to several times a day.

Mobility

The Medistim MiraQ™ System is a trolleybased system. When the probes are in active use, the system will be placed in a stationary position in the vicinity of the sterile field. When the probes are not in active use, the system may be repositioned in the operating room or transported to another operating room or a hospital office by one person. During such transportation, the system may be maneuvered in and out of hospital elevators and over low door thresholds

Visibility

Table 2-1

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Condition

• Ambient illumination levels: 300-400 lux in operating rooms and 50-180 lux in staff offices. • Viewing distance: 40-100cm for buttons, controls and texts (operator) 100-350cm for ultrasound images, traces, and measurement values or indices relevant for the surgical procedure. • The viewing angle, normal to the display will be quite small for the surgeon, who is standing away from the screen (<±20°). The operator may need to look at the screen from a larger angle during surgery (<±50°).

below normal room temperature. Normal temperature range is 20° C to 23° C. • Humidity in the operating room is typically 20% to 60%.

Table 2-1

Intended conditions for use of the ­MiraQ™ System

Intended conditions for use of the ­MiraQ™ System

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2.6 Intended user profiles & personnel requirements In most cases, an operating room nurse will prepare the system before use, adjust the system during operation, and save essential data to document the procedure. The surgeon will control the probe(s) inside the sterile field. The probe(s) may also be handled by a nurse in the sterile field, assisting the surgeon. In the operating room, it should be expected that persons other than the main surgeon/probe operator and system operator may perform certain tasks related to the Medistim MiraQ™ System, for example press an on-screen button, prepare or hold the probes(s) while the main system operator is busy with other tasks. In addition, a system maintainer may access the software user interface to perform changes to the system configuration (e.g. network settings or profile settings), disk maintenance, upgrades or other service tasks. Other hospital staff may also interact with the system, such as personnel responsible for receiving and unpacking the system on-site. The following Table 2-2 lists and describes the characteristics for the different intended user profiles.

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User Profiles

Description

Detailed Profile

System operator

The system operator is the person that has the main responsibility for operating the touch screen user interface.

Education: • No special educational background needed, but certification as operating room nurse or other relevant clinical background is recommended. Knowledge: • Has basic computer skills, including operation of touch screen buttons. • Has a basic understanding of the principle of operation for the system. • Knows the frequently used functions for the system relevant for the procedure, or is capable of operating the system by detailed instructions from a supervisor (e.g. the surgeon). Language understanding: • Understands language of surgeon. • Reads and understands language of software user interface and user manual. Experience: • Previous participation in similar surgical interventions. • Familiarization with the M ­ iraQ™ ­System user interface before the surgical intervention. • May have previous experience with older Medistim flowmeters, as VeriQ™/VeriQ C™, CardioMed or Butterfly. Permissible impairments: • Speech impairments. • One arm capable of operating the touch screen. • Monocular vision. • Olfactory and gustatory impairments. • Lower limb mobility impairments.

Table 2-2

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Medistim MiraQ™ System User Profiles

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User Profiles

Description

Detailed Profile

Surgeon / Probe operator

The probe operator is the person that has the main responsibility for operating the probe(s) during surgical interventions.

Education: • Certified surgeon or other health professional supervised by a certified surgeon Knowledge: • Has detailed knowledge of the surgical procedure. • Has a basic understanding of the principle of operation for the system. • Knows the frequently used functions for the Medistim MiraQ™ System relevant for the procedure, or is capable of operating the system by detailed instructions from a supervisor (e.g. the surgeon). Language Understanding: • Reads and understands language of software user interface and User Manual. Experience: • Previous participation in similar surgical interventions. • Familiarization with the Medistim MiraQ™ System user interface and probes before the surgical intervention. • May have previous experience with older Medistim flowmeters, as VeriQ™/VeriQ C™, CardioMed or Butterfly. Permissible impairments: • One arm capable of operating the probe. • Olfactory and gustatory impairments. • Lower limb mobility impairments.

Table 2-2

Medistim MiraQ™ System User Profiles

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User Profiles

Description

Detailed Profile

System Maintainer

The system maintainer is any person that may perform system configuration or maintenance tasks, for instance a Medistim sales or service representative, or a system responsible at the hospital.

Education • Relevant education and qualifications to do service and repairs on medical equipment. • Attended service training provided by Medistim. • Refer to Service manual for detailed requirements. Knowledge • Has detailed knowledge of the specific task or is operating the system following detailed instructions from a Medistim representative with knowledge of the task. • Has a basic understanding of the principle of operation of touch screen buttons. Language understanding • Reads and understands language of software user interface and the instructions/service manual/User Manual relevant to the task. Experience • Familiar with the Medistim MiraQ™ System user interface. Permissible impairments • Speech impairments. • One arm capable of operating the touch screen. • Monocular vision. • Olfactory and gustatory impairments. • Lower limb mobility impairments.

Probe preparer and cleaner

Table 2-2

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The user responsible for preparing and /or cleaning the probes after use will often share most of the characteristics listed for the System operator. Though probe preparers/cleaners do not need to have any computer skills, they should have detailed knowledge about the cleaning methods valid for the probes in use as well as the Hospital’s procedures for decontamination.

Medistim MiraQ™ System User Profiles

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User Profiles

Description

Detailed Profile

Sterilization / The sterilization and disinfection of probes would normally be performed by dedicated staff or a Hospital Sterilization and Disinfection staff Disinfection Unit (HSDU). The persons involved in the sterilization and disinfection of probes and system should have detailed knowledge about the instructions for handling, cleaning and sterilization of the Medistim products, as well as the decontamination procedures for the Hospital. Table 2-2

Medistim MiraQ™ System User Profiles

2.7 Limitations for use TTFM and Doppler flow measurements are routinely used for non-diseased vessels such as saphenous vein grafts, different arteries and harvested mammaries. In these vessels, thrombus or calcified plaque will not be present. Thrombus or calcified plaque may be present before certain clinical procedures such as carotid endarterectomy or before performing a proximal anastomosis on the aortic arch. In such procedures, or similar procedures, the surgeon may want to measure blood volume flow or velocities prior to any surgical intervention. Manipulation of vessels with thrombus, calcification or other malfunctions in order to measure blood flow may have serious consequences for the patient and is a possible contraindication for performing blood flow measurements. Sound medical judgment should be exercised and the final responsibility for measuring flow in diseased vessels lie with the physician. Any pinching of the vessels during flow measurement should be avoided.

2.7.1

Acoustic power reporting

For Acoustic Output tables, refer to “Appendix A. Acoustic output report”.

2.7.2

Interpreting Thermal and Mechanical Index

The Thermal Index (TI) and Mechanical Index (MI) are two parameters that are always displayed on the screen during ultrasound imaging, and give information about ultrasonic exposure to the patient. This chapter provides guidance on how to interpret these parameters. The MI gives a relative indication of the potential for mechanical effects, such as cavitation. The TI gives a relative indication of the potential for temperature increase along the ultrasound beam. For the Medistim MiraQ™ System, Thermal Index for Soft Tissue (TIS) is displayed.

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The TIS and MI indices do not provide safety limits, but they do provide an indication of the conditions which are more likely than others to produce thermal and/or mechanical effects. See Table 2-3 for an overview of the relative importance of maintaining low exposure indices in various scanning situations. Of greater importance Of lesser importance MI

TI

With contrast agents Cardiac scanning (lung exposure) Abdominal scanning (bowel gas)

In the absence of gas bodies: i.e. in most tissue imaging

First trimester scanning Foetal skull and spine Patient with fever In any poorly perfused tissue Ophthalmic scanning (requires different risk estimate) If ribs or bone are exposed

In well perfused tissue, i.e. liver, spleen In cardiac scanning In vascular scanning

Table 2-3 Relative importance of maintaining low exposure indices in various scanning situations. (Source: International Standard IEC 60601-2-37)

2.8 Environment, health and safety No environmental, health, or safety considerations are related to the Medistim MiraQ™ System. For disposal instructions see chapter “13.5 Disposal instructions”.

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2.9 Possible operational influence As probe size, positioning and placement on the vessel may influence accuracy, it is important that all measurements are performed as described in this manual. To avoid the disruption or corruption of the calculated Diastolic Filling percentage (DF), no action should be taken that compromises the quality of the ECG signal, as DF is dependent on a stable ECG recording.

Warning The Medistim MiraQ™ System does not incorporate any protective means to avoid burns to the patient when used with high frequency surgical equipment that has a defect in the neutral electrode connection. In order to ensure safe use, all probes connected to the system should be removed from the patient during use of high frequency surgical equipment.

Warning The protection of the equipment against the effect of the discharge of a cardiac defibrillator is dependent upon the appropriate use of the Medistim MiraQ™ System. Note If the measurement curves stop or disappear after use of a cardiac defibrillator, the MiraQ™ System should be restarted.

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Note Simultaneous use of Diathermy and flow/velocity measurements should be avoided as the Diathermy interferes with the measurements and can make them unreliable.

2.10

Consumables

2.10.1

Necessary consumable items:

• •

Sterile ultrasound couplant A selection of different probe sizes for use during the surgical procedure.

2.10.2

Optional consumable items:

• •

Ink cartridges for color printer1 Printer paper1

2.11

2.12

Access to spare parts and service

Please contact your local representative to request service or spare parts for the Medistim MiraQ™ System. See www. medistim.com for a list of local contacts and distributors.

Warning No modification of this equipment is allowed without the authorization from the manufacturer. Warning No parts of the MiraQ system should be serviced or maintained during use with a patient.

Warranty

The Medistim MiraQ™ System is warranted against defective material and poor workmanship for a period of 25 months from date of shipment. The Medistim TTFM and Doppler Probes are warranted against manufacturing defects for the specified number of sterilization cycles or one year from the date of first use, whichever comes first. The Medistim L15 High-frequency Ultrasound Imaging Probe is warranted against manufacturing defects for the specified number of sterilization cycles or one year from the date of first use, whichever comes first

Warning If this equipment is modified, appropriate inspection and testing must be conducted by authorized Medistim personnel to ensure continued safe use of the equipment. Warning The internal lithium battery must be replaced by trained service personnel. There is danger of explosion if the battery is incorrectly replaced. Replace only with same or equivalent type recommended by manufacturer. Dispose used batteries according to the manufacturer’s instructions.

1 Only on systems equipped with the printer module © Medistim 2020

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3.

SYSTEM OVERVIEW 19” Touch Screen with GUI Monitor Arm Power button Handle Storage Compartment Front Panel

Media Panel

Ventilation

Cable Hooks and Power Cable

The optional printer and printer unit will be placed here on systems equipped with this option

Front view of the ­Medistim M ­ iraQ™ ­System

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Lockable Wheels

Rear view of the ­Medistim M ­ iraQ™ ­System © Medistim 2020

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