METR I S CA N ONE ENSITY User's Manualelectromedicaldiagnostics.com/ipics/alara_manual.pdf · HP...

Document Number: 203-0199-04 Rev C

Manual Assy Number: 500-1203-01 Rev D

CAN

METR I S ®

B ONE D ENSITY S YS T E M

User's Manual

ALARA, Incorporated 47505 Seabridge Drive • Fremont, CA 94538 USA

Phone 800.410.2525 • Fax 510.315.5201

Document Number 203-0199-04 Rev C

Table of Contents

CHAPTER 1 PRODUCT INFORMATION .................................................................... 3

1.1 OVERVIEW.................................................................................................................... 3

1.2 TECHNICAL SPECIFICATIONS ........................................................................................ 7

1.3 WARNINGS AND CAUTIONS .......................................................................................... 8 1.4 SAFETY SYMBOLS ...................................................................................................... 11

1.5 RADIATION SAFETY.................................................................................................... 12

1.6 REGISTERING METRISCAN ......................................................................................... 13

1.7 INDICATIONS FOR USE ................................................................................................ 13

1.8 CONTRAINDICATIONS ................................................................................................. 13

1.9 KNOWN ADVERSE REACTIONS ................................................................................... 13

1.10 METRISCAN CALIBRATION ......................................................................................... 14

CHAPTER 2 PRODUCT INSTALLATION ................................................................. 15

2.1 OVERVIEW.................................................................................................................. 15

2.2 INSTALLATION PROCEDURE........................................................................................ 16

CHAPTER 3 DIRECTIONS FOR USE ......................................................................... 19

3.1 OVERVIEW.................................................................................................................. 19

3.2 METRISCAN SYSTEM START-UP................................................................................. 20

3.3 NAVIGATING THE MAIN MENU................................................................................... 22

3.4 SETTING OPTIONS....................................................................................................... 23

3.5 PERFORMING AN EXAM .............................................................................................. 25

3.6 VIEWING AND PRINTING RESULTS .............................................................................. 31

3.7 INTERPRETING THE RESULTS ...................................................................................... 33

3.8 FINISHING THE EXAM ................................................................................................. 34

3.9 TROUBLESHOOTING .................................................................................................... 35

CHAPTER 4 MAINTAINING METRISCAN............................................................... 37

4.1 OVERVIEW.................................................................................................................. 37

4.2 CLEANING THE AIR FILTER MEDIA............................................................................. 38 4.3 REPLACING THE FUSES ............................................................................................... 39

4.4 CLEANING METRISCAN .............................................................................................. 40

4.5 MAINTAINING THE PRINTER ....................................................................................... 40 4.6 REQUIRED SERVICE .................................................................................................... 40

CHAPTER 5 REFERENCE INFORMATION ............................................................. 41

5.1 COMPLIANCE TO STANDARDS..................................................................................... 41

5.2 DISPOSAL OF WASTE MATERIALS AND INOPERATIVE PARTS...................................... 42

5.3 GLOSSARY .................................................................................................................. 43

5.4 REFERENCE DATABASE .............................................................................................. 44

5.5 EMC – GUIDANCE AND MANUFACTURER’S DECLARATION ....................................... 45

This manual was originally drafted and approved by Alara, Inc., in the English language.

C H A P T E R 1

M E T R I S C A N P R O D U C T I N F O R M A T I O N

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P R O D U C T I N F O R M A T I O N

1.1 Overview

MetriScan® is a self-contained, tabletop, Bone Density System that uses digital radiographic absorptiometry (RA) to estimate the relative bone mineral density (BMD) of the

middle phalanges of the 2nd

, 3rd, and 4

th digits of the non-dominant hand. On-screen results

are generated in less than one minute. Results are also sent to a printer for a hardcopy record.

Normative and reference databases were established in clinical trials of MetriScan. Using these databases, MetriScan will automatically compute the patient's T-score and Z-score. The T-score compares the patient's estimated relative BMD with that of a young healthy population. This T-score value is used to assess fracture risk for the patient. The Z-score compares the patient's estimated BMD with that of a population of the same age group, gender and ethnicity. The Z-score may help physicians identify secondary causes for low bone density. For more information on the T-score and Z-score, see Section 3.6. Although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors. MetriScan can also be used to monitor changes in bone mass over time.

The US National Osteoporosis Foundation (NOF) guidelines for managing and preventing osteoporosis include specific guidelines for the use of BMD tests. The NOF can provide more information on the use of T-scores to diagnose osteoporosis. The NOF recommendations specify that the following people should have a BMD test:

1. women who are 65 or older, regardless of other risk factors1;

2. postmenopausal women who have one or more risk factors for osteoporotic

fracture (besides menopause); and

3. all postmenopausal women who have had a fracture.

For information, contact the National Osteoporosis Foundation at (202) 223-2226, or www.nof.org.

1 Risk factors for osteoporotic fracture include: personal history of fracture as an adult; history of fracture in a first-degree relative; Caucasian or Asian race; advanced age; female sex; dementia; poor health/frailty; cigarette smoking; low body weight; estrogen deficiency (past menopause, early menopause or bilateral ovariectomy), corticosteroid use >1 yr.

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QVGA Display

X-Ray Expose Button

Numeric Keypad

Hand Support Plate

Field of View Outline

MetriScan Bone Density System (front)

Function Keys

Warning Label

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Remote Cable Receptacle

Parallel Connector

Power Switch

Power Receptacle

Product Label

MetriScan Bone Density System (back)

Labels Below are copies of the labels found on the MetriScan System.

[Located next to Hand Support Plate]

WARNING

This x-ray unit may be dangerous to patient and operator unless

safe exposure factors, operating instructions and maintenance

schedules are observed.

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[Back Panel]

Alara, Inc. Model: MetriScan® Bone Densitometry System

Rx Only

0086

Complies with 21 CFR 1040.10 and

1040.11 except for deviations pursuant to

Laser Notice No. 50, dated June 24, 2007

Source to image detector distance: 185mm

Image receptor size: 68mm x 107mm

This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesirable operation.

CAUTION – CLASS 3B LASER RADIATION WHEN OPEN. AVOID EXPOSURE TO BEAM.

ATTENTION – RAYONNEMENT LASER DE CLASSE 3B EN CAS D’OUVERTURE. EXPOSITION DANGEREUSE AU FAISCEAU.

VORSICHT – LASERSTRAHLUNG KLASSE 3B, WENN ABDECKUNG GEÖFFNET NICHT DEM STRAHL AUSSETZEN.

CLASS 1 LASER PRODUCT

PRODUIT AVEC LASER DE CLASSE 1

LASER KLASSE 1

IEC60825-1:1993+A1+A2

Alara, Inc. Fremont, CA USA

250V

100-240 V ~, 50/60 Hz, 100 VA MAX SN

T2AH

MADE IN USA COVERED BY U.S. PATENTS: 6,490,339: 6,510,197

P/N 500-0985-02 Rev: D

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Technical Specifications

Weight 18.8 kg (41.5 lbs)

Dimensions (Width x Height x Depth) 40.6cm x 40.6cm x 40.6cm (16"x16"x16")

Patient Exposure Entrance Dose to the hand Scatter, Effective Dose Equivalent

≤ 10 mR

<0.02 µSv /exam*

Operator Exposure - Scattered Radiation, Effective Dose Equivalent

18” (46 cm) 36” (0.9 m) 72” (1.8m)

<0.01 µSv/exam*

<0.002 µSv/exam* <0.0005 µSv/exam*

Machine Precision Error

0.85% CV

In Vivo Precision Error 1.1% CV with repositioning

Results Available

Less than 1 minute

Calibration Automatic Verification; Recalibration required after 8,000 exposures

Fixed Anode Voltage 60 kV ± 5%

Fixed Anode Current 0.333 mA ± 5%

X-ray Tube Manufacturer Oxford Instruments

Exposure Time 300 milliseconds ± 5%

Total Filtration 3.5 mm Al equivalent

Half-Value Layer (HVL) 3.0 mm Al equivalent

Image Receptor Storage Phosphor

Image Receptor Size 11.9 cm x 7.2 cm (4.7" x 2.8")

Hand Support Plate Attenuation Negligible

Source to Skin Distance (SSD) 15 cm (5.9")

Source to Image Receptor Distance (SID) 18.5 cm (7.3")

Size of Field of View Outline on Hand Support Plate (Reference Box)

11.4 cm x 6.4cm (4" x 2.5")

Focal Spot Size 0.1 x 0.1 mm (nominal)

X-ray Beam Field Size (at Hand Support Plate centered on Reference Box)

10.54cm x 6.73cm ± 0.025cm

(4.15" x 2.65")

X-ray Source Assembly Duty Cycle < 1%

1.2 Technical Specifications

The following table lists the technical specifications for MetriScan Bone Density System.

Table 1-1

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Operating Temperature 18° to 35°C (64° to 95°F)

Operating Humidity 10%-80% relative humidity, non- condensing

Storage Temperature -40° to 50°C (-40° to 122°F)

Laser Classification Class I

Electrical Classification Class I Type BF electrical product

Mains Voltage 100-240 VAC

Mains Frequency 50 or 60 Hz

Mains Fusing T2AH at 100 - 240 V

Maximum Power 100 VA

Printer HP DeskJet 840C or as specified by Alara. Compliant to IEC 950.

* Note: at short source-to-detector distances, typical measurement precision for scattered radiation is 10-20% due to variation in positioning of hand-held meters.

1.3 Warnings and Cautions

MetriScan is a Class II medical device as defined by the FDA and Class IIb as defined by the European Union Medical Device Directive. The device has been designed and tested in accordance with recognized safety standards.

To ensure safe operation, observe and follow the warnings and cautions listed below. These definitions apply to all WARNINGS and CAUTIONS:

WARNINGS: call attention to any operation, procedure, or practice, which, if not strictly observed, may result in injury or long-term health hazards to personnel or patient.

CAUTIONS: call attention to any operation, procedure, or practice, which, if not strictly observed, may result in destruction of equipment or loss of diagnostic effectiveness.

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WARNINGS Observe safe operating instructions

While every effort has been made to ensure the highest levels of safety, this X-ray unit may be dangerous to the patient and operator unless safe operating instructions are observed.

Should be used only for indicated procedures

Use of this device in procedures other than those described in this User’s Manual may result in injury.

Use only grounded electrical connections

Connect MetriScan to a grounded electrical outlet between 100-240 V. Connecting to a power source that is not equipped with a protective earth contact creates a shock hazard for the operator and patient. Likewise, interrupting the protective conductor inside or outside the device or disconnecting the protective earth terminal creates a shock hazard for the operator and patient.

Use only fuses with the required current rating and of the specified type

Make sure that only fuses with the required current rating and of the specified type are used for replacement. The use of incorrect or makeshift fuses or the short-circuiting of fuse holders creates a shock hazard for the operator and patient.

Do not operate MetriScan near flammable or explosive materials

MetriScan should not be placed or operated near flammable or explosive anesthetics, liquids, vapors or gases.

Do not remove the protective covers of MetriScan

None of the internal parts of MetriScan is user serviceable. As outlined in Chapter 4, user serviceable parts may be accessed without removal of the protective covers. The manufacturer must perform all other service. For assistance, contact your local distributor.

Do not use MetriScan if the protective covers are broken

If the protective covers on MetriScan are broken, do not use the system. Contact your local distributor.

Not yet established in the diagnosis of Renal Osteodystrophy

The need or appropriateness of BMD measurements of the phalanges in the treatment of renal osteodystrophy has not yet been established.

MetriScan is a Class 1 laser device

MetriScan is a Class 1 laser device when its covers are in place. When the covers are removed, laser light from the embedded Class 3B laser diode (635 nm, 5 mW CW max power) may be present. Direct eye contact with the output beam from the laser may cause serious damage and possible blindness. Do not remove the protective covers of MetriScan.

Use only supplied accessories

Only the specified and included printer and remote cable should be connected to MetriScan. The connection of any other devices to MetriScan may compromise compliance with electrical and EMC safety standards.

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Should be used only by qualified professionals

As the owner of MetriScan, you are responsible for insuring that only properly trained and qualified people operate it and that it is used only by or on the order of a physician or other properly licensed practitioner.

Use according to directions

MetriScan should only be used according to the directions provided in this User’s Manual. Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

Use medical judgement

The estimated relative BMD values obtained with this device should be only one factor in a medical judgement that treatment is warranted for a disease or disorder.

CAUTIONS Do not place MetriScan on or next to a radiator or water source

Excessive heat or small amounts of water may damage MetriScan's electrical components.

Printer Placement

To maintain compliance with the international standard IEC 60601-1-1, Safety Requirements for Medical Electrical Systems, the printer must be compliant with IEC 60950 and be located at least 1.6m from the patient.

Electromagnetic Interference

Users should be aware of the potential for electromagnetic interference between devices whenever they use electronic equipment. International standards exist to minimize this potential. MetriScan has been tested against and complies with the international standard EN 60601-1-2, Medical Electrical Equipment – General Requirements for Safety – Collateral Standard; Electromagnetic Compatibility Requirements and Tests, class B.

To avoid interference with electric and magnetic fields, do not place MetriScan near:

• X-ray equipment that is constantly energized (e.g., devices such as fluoroscopes which are energized when not in use)

• Magnetic resonance imaging systems • Large motors • Electric generators

Do not locate in direct sunlight

Direct sunlight can damage the MetriScan display screen and interfere with MetriScan’s ability to function properly. It is acceptable to have MetriScan in a room where there is direct sunlight as long as the sunlight does not shine directly on MetriScan.

Treat the display screen with care

Guard against scratching the face of the display screen. To clean the display screen, wipe it swiftly with cotton or other soft cloth. If it is still not completely clear, blow on it and wipe again. Since the display screen is made of glass plates, banging hard objects against it may cause cracking.

Do not plug remote cable in when green lights around exposure button are on Users wanting to use the remote cable to initiate x-ray exposure should plug the remote cable in before initiating a new exam. Plugging the remote cable in to MetriScan when the system is ready to initiate an x-ray exposure (as indicated by green lights on either side of the exposure button) will result in an inadvertent x-ray exposure.

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Safety Symbols

Symbol

Location

Description

Back Panel

Indicates that the user should refer to the instruction manual in order to protect the device against damage.

Interior

Indicates presence of dangerous voltages within the device.

Front Panel

Upper Right & Remote

Cable

X-ray exposure button. Green lights next to symbol indicate that the system is ready to produce X-rays. Yellow lights next to symbol indicate that the system is producing X-rays.

Front Panel

Upper Left

System power status. Green light next to symbol indicates that the system power is on.

Back Panel

Lower Left

ON position of the AC power.

Back Panel

Lower Left

OFF position of the AC power.

Interior

Indicates protective earth ground terminal.

Back Panel

Indicates fuse.

~

Back Panel

Indicates alternating current (AC).

Back Panel

Indicates type BF electrical classification.

1.4 Safety Symbols

Table 1-2 shows the safety symbols that are used either inside or outside MetriScan and throughout this manual.

Table 1-2

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1.5 Radiation Safety

MetriScan produces x-ray radiation only when you give the appropriate commands in the software. Green x-ray-ready lights illuminate adjacent to the exposure button when MetriScan is ready to produce x rays. When you press the exposure button, these lights turn yellow to indicate that x rays are being produced. The yellow lights turn off and a tone sounds to indicate the end of the fixed exposure time of 0.3 seconds.

MetriScan also comes with a two meter (6.5 foot) remote cable with which the x-ray exposure can be initiated. Fully extended the cable is four meters (13 feet). When the cable is attached to MetriScan, the button on the end of the remote will initiate the x- ray exposure if pressed when the green lights on either side of the exposure button on MetriScan are illuminated. The green lights will turn yellow while the x rays are being produced, and the tone will sound when the exposure is complete. While x-ray exposure to the operator is low when using the exposure button on the front panel, use of the remote cable exposure button will result in less stray radiation exposure to the operator.

The dimension of the radiation field at the Hand Support Plate is 10.54 cm by 6.73 cm + 0.02 (4.15” by 2.65” ± 0.01). The entrance dose to the patient is 10 mR; the total effective dose equivalent (TEDE) from scattered radiation to the patient is < 0.02 µSv, comparable to exposure from natural background radiation for 4 minutes. Scattered

radiation to the operator (1m from the unit) is less than 0.002 µSv/scan (2 x 10-4

mrem/scan).

Government health departments often require medical facilities to register x-ray equipment. Many government health agencies require medical facilities to employ certified radiological technologists to operate x-ray devices. Some agencies provide an exemption or reduced certification requirements when the only x-ray device operated is a peripheral bone density system such as MetriScan. Contact the health departments in your location to ensure compliance with their regulations.

It is recommended that you post an x-ray caution sign in the area or room where you use the MetriScan. The area or room in which the MetriScan is used does not require additional shielding in the walls, floor, or ceiling because of the negligible levels of leakage radiation from the x-ray tube assembly and of scattered radiation from MetriScan.

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MetriScan Specifications

Serial Number Check the label on the back of the unit

X-ray Head Number Same as serial number

Maximum Tube Voltage 60 kV ± 5%

Maximum X-ray Tube Current 0.333 mA ± 5%

Patient X-ray Exposure: Entrance Dose ≤ 10 mR

Patient X-ray Exposure: Effective Dose Equivalent

< 0.02 µSv per exam

Scattered radiation, 1m: Effective Dose Equivalent

< 0.0016 µSv per exam

1.6 Registering MetriScan

In most places, users will be required to register MetriScan with their government’s radiologic health department.

In Table 1-2 below, you will find the basic technical information that you may need to supply when registering.. For further product specifications, see Section 1.2 of this manual: Technical Specifications.

Table 1-2

1.7 Indications for Use

MetriScan is indicated for use in estimating relative bone mineral density (BMD). The estimate of relative BMD and T-score may be used as an aid to the physician in determining fracture risk, and for monitoring changes in bone mass over time.

1.8 Contraindications

Contraindications include:

¾ A deformity that prevents all three of the patient’s middle fingers from being positioned

properly (at least one finger must be positioned properly).

¾ Orthopedic hardware in all three of the patient’s middle fingers.

¾ Pregnancy.

1.9 Known Adverse Reactions

There are no known adverse reactions.

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1.10 MetriScan Calibration

Each MetriScan system is calibrated at the factory. Each time the system is turned on it performs self-diagnostics and collects a reference image. Calibration is verified during each exam using an aluminum alloy reference wedge. Should any of the diagnostic or calibration checks fail, an error message will be generated.

In order to maintain the highest level of performance, recalibration is required after 8,000 exposures. When 7,000 exposures have been performed, the following message will be displayed when the system is turned on:

Your MetriScan is due for required maintenance within the number of scans shown below. Once this limit is reached, your MetriScan will no longer operate. Please contact your distributor or Alara at your earliest convenience to schedule maintenance.

Remaining Scans: XXXX

800.410.2525 510.315.5203 [email protected]

Recalibration must be performed by the factory or by an authorized service center. If recalibration is not performed before the 8,000 exposure limit is reached, MetriScan will be disabled.

Please refer to the troubleshooting section of this manual for further instruction.

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C H A P T E R 2

M E T R I S C A N P R O D U C T I N S T A L L A T I O N

Power Requirements

Supply Voltage 100-240 VAC

Supply Frequency 50 or 60 Hz

Power 100 VA maximum

Space Requirements

Component

Dimensions (W x H x D)

Weight

MetriScan 40.6 cm x 40.6cm x 40.6 cm (16"x16"x16")

18.8 kg (41.5 lbs)

Printer 38.1 cm x 22.9 cm x 17.8 cm (15"x9"x7")

2.7 kg (6 lbs)

C H A P T E R 2

P R O D U C T I N S T A L L A T I O N

2.1 Overview

This chapter provides installation instructions for the following:

• MetriScan Bone Density System • Printer

To ensure safe and reliable operation the installation site must be prepared prior to installation according to the following power and space requirements.

� Power Requirements MetriScan and the printer require access to 2 standard grounded local electrical outlets. To achieve the enhanced grounding reliability of the hospital grade plug provided with MetriScan, use an outlet marked “hospital only” or “hospital grade”. This is intended to protect other critical equipment which may be on the same circuit. Table 2-1 lists the power

requirements:

Table 2-1

� Space Requirements A stable, flat countertop large and strong enough to hold MetriScan must be available. The printer does not need to be on the same countertop, but must be located within 9 feet of MetriScan, which is the maximum length of the cable that connects the printer and MetriScan. Table 2-2 lists the dimensions and weights of each component:

Table 2-2

� Do Not Locate in Direct Sunlight Direct sunlight can damage the MetriScan display screen and interfere with MetriScan’s ability to function properly. Do not locate MetriScan in an area where direct sunlight will

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shine on MetriScan. It is acceptable to have MetriScan in a room where there is direct sunlight as long as the sunlight does not shine directly on MetriScan.

2.2 Installation Procedure

� Contents of the Shipping Container

Printer

MetriScan

Remote Cable

MetriScan Power Cord

User’s Manual

� Hardware Printer Cable Printer Power Cord

Only the specified and included printer and remote cable should be connected to MetriScan. The connection of any other devices to MetriScan may compromise compliance with electrical and EMC safety standards.

Step 1 ¾ Unpack MetriScan Bone Density System and place in the location chosen per the

guidelines listed in Section 2.1

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¾ Unpack the printer and place in the

location chosen per the guidelines listed in Section 2.1.

¾ Per manufacturer's instructions, set up

the printer. Connect the printer cable into

Parallel Connector

Power Receptacle

the parallel connector on the printer.

¾ Connect the other end of the printer cable

into the parallel connector located on the back of MetriScan. Tighten the connector screws on both ends of the cable.

Step 2

Step 3

¾ Verify that the power switch is off (refer to

Section 3.1 for instructions).

¾ Plug the power cord into the power

receptacle located on the back of MetriScan. Plug the other end of the power cord into a grounded outlet per the guidelines listed in Section 2.1. Note that the use of multiple portable socket outlets should comply with EN 60601-1-1.

Power Receptacle

Step 4

(Optional)

Step 5

¾ Plug the remote cable into the remote cable receptacle.

The remote cable allows the operator to initiate x-ray exposure at a distance of up to 4 meters from MetriScan. Use of the remote cable is optional and the cable may be plugged in at any time during the system’s use except when the green “ready to expose” lights are illuminated. (See the “Remote Cable” section which follows for more information concerning use of the remote.)

¾ Do not plug anything else into this receptacle. The connection of any other devices to

MetriScan may compromise performance and/or electrical safety.

¾ Following the manufacturer's instructions, power on the printer.

¾ Turn on the MetriScan power switch (refer to Table 1-2).

¾ If MetriScan completes its calibration check without error, the system has been

installed properly. See Section 3.2 for information on MetriScan system start-up.

WARNING


None of the internal parts of MetriScan is user serviceable. As outlined in Chapter 4, user serviceable parts of the system may be accessed without removal of the protective covers. All other service must be made by the manufacturer. For assistance, contact your local distributor.

� The Remote Cable MetriScan comes with a two meter (6.5 foot) remote cable, which functions as a remote X-ray Expose button. Fully extended, the cable is four meters (13 feet). Use of the remote

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cable is optional. The scatter radiation from MetriScan is low close to the device, but using the remote cable to stand further from MetriScan makes exposure to scattered radiation even lower, and lower is always better. As an example, the effective dose equivalent limit established by the U.S. Nuclear Regulatory Commission for individual members of the public is 100 mrem per year. Using the exposure button on the front panel, the operator effective dose equivalent exposure is 0.001 mrem per scan; an operator would need to perform almost 50 scans per hour, 8 hours per day, 5 days per week, 50 weeks per year to reach this limit. Using the remote cable and standing six feet from MetriScan, the operator effective dose equivalent exposure is 5 x 10

-5 mrem; an operator would need to perform

1000 scans per hour 8 hours per day 5 days per week 50 weeks per year to reach the limit.

The remote cable does not need to be plugged into MetriScan before the system is powered on; it can be plugged in after the system has been turned on. The remote cable should not be plugged in when the green lights on both sides of the exposure button are lit. Plugging the remote cable in at this time could result in an inadvertent x-ray exposure.

To use the remote cable, plug the cable into the remote cable receptacle on the back of MetriScan, and press the button on the remote cable instead of pressing the X-ray Expose button on the unit.

Note that when the remote is plugged in, exposures may still be made using the Expose button on the front of MetriScan.

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C H A P T E R 3

M E T R I S C A N D I R E C T I O N S F O R U S E

C H A P T E R 3

D I R E C T I O N S F O R U S E

3.1 Overview

Operator ID and patient information (ID Number, age, gender and ethnicity) is entered. The operator positions the patient's hand and initiates the x-ray exposure. An x-ray image of the patient’s hand is produced. MetriScan analyzes the image, computes the estimated relative BMD and determines the T- and Z-scores. The operator may print the report for the hardcopy record and begin a new exam.

Step 1

Step 2

� Powering the System On MetriScan is designed to be powered-on continuously during the day. The laser and x-ray generator are only operational while the device is performing a exam. Use the following procedure to power on the system:

¾ Following the manufacturer's instructions, power on the printer.

¾ Push the power switch located on the back of

MetriScan to the "|" position.

The green LED next to the power status symbol on the front panel should illuminate.

� Powering Off the System MetriScan should be turned off each evening so that the calibration check is performed daily. Use the following procedure to power off the system:

Step 1

Step 2

¾ Wait until any exam in progress has completed.

¾ Push the power switch located on the back of

MetriScan to the "O" position.

¾ Following the manufacturer's instructions,

power off the printer.

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3.2 MetriScan System Start-Up

When MetriScan is turned on, it will run a short self-test routine. When the self-test routine finishes, MetriScan displays its date and time setting. If the date and/or time are incorrect, reset them before proceeding.

Step 1 ¾ Verify that MetriScan’s date and time settings are correct. If the settings are correct,

press the OK key on MetriScan.

¾ If the date and time settings are incorrect, press the Set Date/Time button on

MetriScan.

Press the Set Date button and, using the numeric keys on MetriScan, enter the day, press the Next button, enter the month, press the Next button, and enter the year and press the Enter button. If any one of the settings is already correct, just press the Next button to proceed to the next item. When finished, press the enter button.

Press the Set Time button and using the numeric keys on MetriScan, enter the hours, press the Next button, then enter the minutes and press the Enter button.

The format of the date can be toggled between Month/Day/Year and Day/Month/Year. Press the date format button to toggle between the two date formats.

The format of the time can be toggled between 12-hour and 24-hour. Press the 12 Hour (24 Hour) button to toggle between the two time formats.

¾ When the date and time are correct, and the desired formats are set, press the OK

button. Verify that the date and time are correct and press the OK button again.

Step 2

¾ MetriScan prepares to perform a

calibration check and displays the following messages on the screen.

¾ Make sure the imaging area is clear.

Diagnostics and Reference Image Collection

The Alara MetriScan is performing a calibration check. In approximately 30 seconds, you will be requested to initiate an x-ray exposure.

An x-ray exposure is required at this time. The imaging area should be clear.

When ready, please press and hold the exposure button until you hear the tone indicating the end of exposure.

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Step 3 ¾ Press the X-ray Exposure button on the front panel of MetriScan or on the remote

cable.

MetriScan begins its calibration, which takes approximately two minutes. When complete, the Main Menu will appear and the system will be ready for use.

� Extended System Calibration Check MetriScan verifies calibration each time it is turned on using a built-in aluminum alloy wedge in the reference area. In some instances, MetriScan may require one or two additional exposures to complete its calibration check as it optimizes hardware settings. If your MetriScan is configured with a controlled inventory of scans, these calibration check exposures do not count against the scan inventory.

Other than pressing the X-ray Expose button during the calibration check at system start-up, no further operator involvement is required to confirm calibration of MetriScan. See section 1.10 for further information on calibration.

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3.3 Navigating the Main Menu

Once the system has collected the reference image, the Main Menu automatically appears. The first time the Main Menu appears after being powered on, the menu will offer two options, as shown below.

Main Menu

Options �

�

� Function Keys

� New Exam �

When the results of a prior exam are in MetriScan’s memory, the Main Menu will show two additional options:

Main Menu

Options �

�

Print Prior Exam �

Re-Analyze Prior Exam �

New Exam �

Function Keys

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3.4 Setting Options

To set MetriScan default options, push the Options button (function key) on the Main Menu. The Options menu will appear:

Options

Patient �

Report �

Date and Time �

Enable Password �

Done �

Function Keys

If at any time, you wish to exit the Options menu and return to the Main Menu, press

Done.

Step 1

Step 2

� Setting Default Patient Information To set default patient information, press the Patient button in the Options menu. Then enter the desired default modes for Patient ID and Ethnic Group.

¾ Patient ID:

Determine whether or not you would like to include a patient ID number on your reports. Press Select to toggle between “Don’t Use” and “Use”. If you select “Use”, a numeric patient ID must be entered for each exam. If you select “Don’t Use”, the patient ID must be written onto the hardcopy test report. If your patient ID’s include letters of the alphabet, you should select “Don’t Use”.

¾ Ethnic Group:

Use the Select button to highlight the desired default ethnic group.

Select OK to return to the Options menu.

� Changing Report Options To access the Report Options menu, press the Report button in the Options menu. The

Report Options menu allows you to choose the print quality and number of reports that will be generated when you press the “Print” function key at the end of the exam.

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Step 1

Step 2

Step 3

¾ Copies:

Enter the number of copies you would like printed at the end of each exam by using the numbered keypad. The maximum number you may select is nine.

¾ Print Quality:

The default print quality is low. If high print quality is desired, choose "Select" to toggle between Low and High print resolution. Please remember that high-resolution printouts take longer than low.

¾ Print Image:

The default selection is color. If black and white print-outs are desired, choose “Select”

to toggle between Color and Black and White.

Select OK to return to the Options menu.

� Setting the Date and Time To reset the date and time, press the Date and Time button. Then follow the directions in Section 3.2, Step 1.

� Setting a Password You may enable password protection to ensure that MetriScan is used only by qualified operators. When the password is enabled, it must be entered at system start-up and when waking MetriScan from “sleep” mode. To set a password, press Enable Password.

¾ Using the numeric keys on MetriScan, enter a 4-digit password. Press Next.

¾ MetriScan will ask you to verify your password. Enter the same 4-digit password again

and press next.

¾ The system will remind you to record your password in a safe place. Press Enter to

return to the Options Menu.

Note that if the system sleeps when a password is enabled, you will need to enter your password in order to restart the system.

� Disabling a Password Once a password has been entered, the Enable Password button in the Options menu will change to Disable Password. To disable the password, press the Disable Password button.

¾ Press the Disable Password button.

¾ A screen will appear informing you that the system is no longer password protected.

¾ Press OK to return to the Options Menu.

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� Master Password Each MetriScan has a master password. If you forget or lose your password, either you may disable the password through the Disable Password button in the Options Menu, or you may use the Master Password for the system. The master password is 3-93.

To use the master password, enter 3-93 when the system requests your password.

3.5 Performing an Exam

Step 1

Step 2

� Entering the Patient Information To perform an exam, the operator enters information for the patient’s ID number, age, gender, and ethnicity. This information is recorded on the test printout. Use the following procedure to enter the information:

¾ Press the New Exam button in the Main Menu. A Patient Information screen will

appear.

¾ Enter your operator ID number using the numeric keypad and press Enter. Then enter

a Patient ID number (if selected in default settings) using the numeric keypad and press Enter. Enter the patient age using the numeric keypad and press Enter. Choose a patient gender by using the Select button to toggle between Female and Male, and press Enter. Use the Select button to highlight the appropriate ethnicity, and press Enter.

¾ A menu will appear asking you to verify your entries. This will allow you to make any

necessary changes to the information. If you would like to make changes, press the Modify Entries button. This will allow you to recommence the data-entry process. Once the information on the screen is correct, press Accept Entries.

Step 3

¾ At this point, you will be ready to begin the exam. The screen will display a message

asking you to place the patient’s hand in the imaging area. Proceed immediately with the following directions for Positioning the Patient’s Hand.

¾ To cancel the exam, press the Cancel Exam button. A menu will appear asking you if

you are sure you want to cancel this exam. Press the Cancel Exam button to return to the Main Menu. Press the Continue Exam button to continue the exam. The screen will display a message asking you to place the patient’s hand in the imaging area. Proceed immediately with the following directions for Positioning the Patient’s Hand.

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Step 1

� Positioning the Patient’s Hand Proper hand positioning is important in order for MetriScan to identify the correct region of interest. Incorrect region of interest can lead to inaccurate test results. To improve hand positioning and patient comfort, remove any jewelry from the fingers whenever possible.

Use the following procedure to position the patient’s hand:

¾ Remove jewelry from the

patient’s non-dominant hand and position this hand on the Hand Support Plate as shown. The hand must be placed palm down with the middle three fingers resting in the molded recesses of the Hand Support Plate. The fingers should be as flat as is comfortably possible on the surface of the plate. Make sure the fingers do not cover the ridges of the handplate near the top of the box.

Step 2 ¾ Make sure that the patient’s

hand is positioned far enough forward that the proximal

interphalangeal joints of the 2nd

, 3

rd, and 4

th digits are all just

inside the imaging reference box. The middle phalanges of each finger should be entirely within the box. But the hand should not be so far forward

Proximal

Field of View Outline

that the webbing between the fingers covers the bottom line of the box on the handplate.

Interphalangeal Joints

Step 3 ¾ Ask the patient to remain perfectly still, being especially careful not to move his/her

hand, until the tone sounds indicating the end of the exposure.

¾ Proceed immediately with the following directions for Initiating the X-ray Exposure.

When initiating x-ray exposure, the patient’s hand must be flat on the plate.

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Correct Hand Positioning

Fingers Do Not Obstruct Boxes on Handplate

Dashed Line Visible Above Webbing Between Fingers

Incorrect Hand Positioning – Hand Too Far Forward

Finger Webbing Covers Dashed Line on Handplate

Incorrect Hand Positioning – Fingers Cover Ridges on Handplate

Fingers Cover Ridges Which Must Remain Clear

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� Initiating the X-ray Exposure The x-ray Expose button is located at the top right hand side on the front panel of MetriScan (see the figure on page 4 of this manual). After pressing the Continue Exam button, the lights next to the Expose button turn green, indicating that pressing the button will result in x-ray exposure. The Expose button must be pressed until an audible tone is heard (0.3 seconds). While x rays are being produced, the button’s lights are yellow. At the conclusion of the timed exposure, the yellow lights turn off and the tone sounds, indicating that the button may be released. If the Expose button is released prematurely, an error message will result and it will be necessary to repeat the exam.

When the x-ray exposure is initiated, MetriScan begins to collect and analyze the patient’s BMD test data. A message will appear informing you that the x-ray is complete. Remove the patient’s hand from the imaging area according to the prompt.

Step 1

Step 2

Use the following procedure to initiate the x-ray exposure:

¾ When the LED’s are green, PRESS and HOLD

DOWN the x-ray Expose button on the front panel of MetriScan.

¾ Continue to HOLD DOWN the Expose button

while the LED's are yellow.

¾ Releasing the button prematurely causes an

error. If this occurs, begin the exam again.

Step 3 ¾ Release the x-ray Expose button AFTER the

audible tone sounds, indicating that the exposure is complete.

Step 4 ¾ Remove the patient’s hand from the imaging

area according to the prompt on the screen.

X-ray complete.

Please remove the patient’s hand from the imaging area.

� Using the Remote Cable X-ray exposure may also be initiated using the remote cable. The remote cable performs the same function as the x-ray Expose button, with the advantage that the button on the remote cable may be pressed while standing up to 4 meters away from MetriScan. Use of the remote cable is optional. The scattered radiation from MetriScan is low close to the device, but using the remote cable to stand further from MetriScan makes exposure to scattered radiation even lower. See the “Remote Cable” section beginning on page 16 for further information.

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To use the remote cable, follow the instructions for Initiating X-ray Exposure, but press the button on the remote cable instead of pressing the X-ray Expose button on the unit.

� Evaluating the Region of Interest The regions of interest for MetriScan defined by the white outlines in the displayed image should be the middle phalanges of the 2

nd, 3

rd and 4

th digits as shown below.

When the x-ray exposure is initiated, MetriScan will read the digital x-ray image, locate the regions of interest, and compute the patient’s estimated relative BMD. At the conclusion of the data analysis, MetriScan displays the image of the patient’s hand with the regions of interest outlined in white. If MetriScan believes the region of interest is properly identified for a finger, that finger will be labeled on screen as Included. The operator then determines if the outline around each phalanx correctly captures the required region. If the operator determines the region of interest is not correct, the operator may exclude a finger or fingers from the analysis by pressing the Exclude buttons. Once the regions of interest have been evaluated and either accepted or excluded, the operator presses OK to continue.

If MetriScan has not identified any region of interest (i.e. none of the phalanges is outlined), then the results of the test are not valid. In this case, repeat the exam taking special care to assure the patient’s hand is positioned properly.

MetriScan requires only one accepted finger to provide a relative BMD estimate.

Step 1 ¾ Evaluate the regions of interest, identified by the white line drawn around the area that

is analyzed. Improper hand positioning can cause the software to incorrectly identify the region of interest and calculate an incorrect relative BMD estimate. The region of

interest should be the middle phalanx of the 2nd

, 3rd, and 4

th fingers (i.e. index, middle

and ring fingers). If the white lines on any finger do not outline the middle phalanx, that finger should be excluded from the analysis to prevent MetriScan from providing an incorrect estimate of relative BMD.

An example of a good image is shown below:

A finger should also be excluded if the image reveals an irregularity, such as prior fractures, bone spurs, or orthopedic hardware.

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Step 2 ¾ To exclude a finger due to an irregularity or incorrect region of interest, press the

Exclude Fingers button. ¾ MetriScan will then give you the option to exclude individual fingers. The fingers are

numbered #1, #2, and #3, from left to right. To exclude a finger, press Exclude #1, Exclude #2, and/or Exclude #3.

¾ Press OK to view and/or print the results. ¾ MetriScan is capable of providing a relative BMD estimate based only on one included

finger. If none of the regions of interest was acceptable and all three fingers are excluded, you will need to repeat the examination, paying close attention to the hand positioning.

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3.6 Viewing and Printing Results

Once the regions of interest have been evaluated and the operator has pressed OK, the View Image screen is displayed, which gives the operator three options: Exclude Fingers, View Results and Print. The Exclude Fingers button allows the operator to return to the image of the hand and reevaluate the regions of interest. The View Results button allows the operator to view the results of the test on the screen, and the Print button allows the operator to print a hard copy of the results.

� View Results To view the test results on the screen, press the View Results button after accepting regions of interest. MetriScan will display the relative BMD estimates for each included finger, the average relative BMD estimate, and the T- score for the patient, and the Z-score.. From this menu, the operator may choose to finish the exam, edit the patient information, return to the

View Image menu, or print the results.

¾ Finish

Press the Finish button to end the exam and return to the Main Menu.

¾ Edit Patient Information

The Edit Patient Information button allows the operator to modify the patient information displayed on the screen. Press the Edit Patient Information button. Press Accept after verifying or modifying the information for operator ID, patient ID, patient age, patient gender, and ethnic group. Once all of the patient data has been accepted, MetriScan will return to the Results screen, recalculating if necessary.

¾ View Image

The view image button will return you to the View Image screen described above, which offers options to Exclude Fingers, View Results, or Print.

¾ Print

Press the Print button to print a hard copy of the results.

� Print Press the Print button to print a hard copy of the results.

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MetriScan Printed Test Results

Patient and Exam Information

Image used to verify outline of phalanges

Estimated relative BMD for each finger. If MetriScan could not identify the proper bone, this will say "not found". If the finger was excluded from the analysis, it will show "not used".

Reference database used for T-Score as well as Z-Score and curve if appropriate database is available

Curves illustrate average T-Score and ± 1 SD values by age if appropriate database is available

Sequential Scan Number

MetriScan latest calibration check and operator ID

Footnotes

Average of all fingers included in the analysis. This value is used to determine T-Score

T-Score calculated using reference database based on patient’s gender and ethnicity. See Section 5.4 for more details

Result calculated by dividing patient’s BMD by the peak BMD for young healthy normals

Z-Score based on the reference database matching the patient’s age, gender and ethnicity. If a matching database is not available, this will show "N/A"

Result calculated by dividing patient’s BMD by the BMD of an age-matched peer group

Results: See Section 3.6

MetriScan serial number and software version

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3.7 Interpreting the Results

MetriScan reports a number that is the average of the estimated relative bone density of

each of the three fingers evaluated. This number is in g/cm2. It is compared to the normative

data to generate a T-score, and to gender/ethnicity matched reference database to generate a Z-score. The estimated BMD and T-score may also be used to monitor changes in bone mass over time.

� T-Score The T-score is calculated based on the mean and standard deviation of the young (20 – 39 years of age) healthy normative data corresponding to the patient’s gender and ethnicity if available. The T-score indicates the number of standard deviations a patient’s estimated BMD value is away from the normative mean BMD estimate. A positive value indicates that the patient’s estimated BMD value is higher than the mean, and a negative value indicates that the patient’s estimated BMD value is lower than the mean. The T-score may be used as an aid to the physician in the diagnosis of osteoporosis or osteopenia.

T-Score Analysis

Normal

T-Score ≥ -1

Osteopenia

-1 > T-Score > -2.5

Osteoporosis

T-score ≤ -2.5

The T-Scores from any two skeletal sites (e.g. finger and hip) are not perfectly correlated, particularly in the decade following menopause when bone densities in peripheral sites may drop before central sites. A physician should base his or her diagnosis on the lowest T-Score obtained regardless of site.

� Z-Score MetriScan calculates the Z-score based on the mean and standard deviation of reference data for which the gender, ethnicity, and age match those of the patient. If such a matching reference database is not available, MetriScan will not calculate a Z- score, and will not display a reference curve.

The Asian reference database covers ages 10-89, the Caucasian covers ages 20-85. If the patient’s age is outside this range, a Z-score is not calculated.

The Z-score may be used by the physician as an aid in the diagnosis of secondary causes of low bone density.

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� Percent of Peak BMD This result is calculated by dividing the patient’s BMD by the peak BMD for young healthy normals.

� Percent of Peer BMD This results is calculated by dividing the patient’s BMD by the BMD of an age-matched peer group.

� Factors Affecting Results MetriScan machine precision is 0.85% (coefficient of variation). Fingers showing incorrect region of interest or other anomalies should be excluded from the analysis.

3.8 Finishing the Exam

Once an exam has been finished, MetriScan will return to the Main Menu. The Main Menu offers the following selections:

Main Menu

Options �

�

Print Prior Exam �

Re-Analyze Prior Exam �

New Exam �

Function Keys

¾ Re-Analyze Prior Exam

The Re-Analyze Prior Exam button (function key) returns the operator to the View

Image screen from the prior exam.

¾ Print Prior Exam

Press the Print Prior Exam button to print the prior exam.

Note that the results from the Prior Exam will only be available until the New Exam button is pressed. As soon as the operator presses the New Exam button, all data from the prior exam will be erased.

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3.9 Troubleshooting

Error Types

There are three types of error messages, each of which requires a different operator response.

Type 1

Type 2

Type 3

¾ ERR_FATAL

To correct the problem, reboot the system using the power switch on the back of the unit. If the error persists after power recycle, contact your local distributor.

¾ ERR_ERROR

The current scan will need to be restarted to correct the problem. If this type of error occurs during scan code input, re-enter the scan code.

¾ ERR_INFO

Press OK to continue. This type of error is informational only.

In the unlikely event that MetriScan’s software crashes, reboot the system, using the power switch located on the back of the unit. If the problem persists, contact your local distributor.

Common Correctable Errors

The most common correctable error types are listed below.

¾ ERROR_58_WEDGE_IS_NOT_IN_CORRECT_POSITION

If this error occurs during a patient exam, then one or more of the patient’s fingers is covering a portion of the ridges on the handplate. This blocks the imaging of the aluminum wedge that is beneath one of the ridges, and thus makes estimation of the bone density impossible. This error is more likely to occur if the hand is positioned too far forward on the handplate, or if fingers are not straight. If this error occurs, reposition the patient’s hand taking special care to assure that none of the fingers covers the ridges of the handplate and that the field of view outline is visible above the webbing. When this is done, retake the image. Please refer to “Positioning the Patient’s Hand” in Section 3.4.

¾ ERROR_73_EXPOSE_KEY_OR_REMOTE_SWITCH_IS_SHORTED

This error can occur when the exposure button is stuck in the expose (pressed) position. Make sure the exposure button is not stuck by pressing it. It should pop up after you let go. Note that the x-ray exposure will cease after the preset time of 0.3 seconds even if exposure key is struck.

¾ ERROR_74_X-RAY_EXPOSURE_CANCELED_BEFORE_COMPLETION

If the operator stops pressing the exposure button before the exposure is complete (when the units beeps), this error will occur. Simply restart the exam. It will take 1-2

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minutes for the unit to erase the imaging plate.

¾ ERROR 130_MEAN_VALUE_OUT_OF _RANGE

This error occurs if the patient’s fingers cover part of the ridges of the handplate. This error is more likely to occur if the hand is positioned too far forward on the handplate, or if fingers are not straight. If this occurs, reposition the patient’s hand making sure that none of the fingers cover the ridges of the handplate, and start the exam again. Please refer to “Positioning the Patient’s Hand” in Section 3.4.

¾ ERROR 131_SNR_VALUE_IS_OUT_OF _RANGE

This error occurs if the patient’s fingers cover part of the ridges of the handplate. This error is more likely to occur if the hand is positioned too far forward on the handplate, or if fingers are not straight. If this occurs, reposition the patient’s hand making sure that none of the fingers cover the ridges of the handplate, and start the exam again. Please refer to “Positioning the Patient’s Hand” in Section 3.4.

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M E T R I S C A N M A I N T E N A N C E

C H A P T E R 4

M A I N T A I N I N G M E T R I S C A N

4.1 Overview

This chapter describes how to maintain the MetriScan Bone Density System. For your safety and the safety of those around you, please read all of the information in this introduction and in Chapter 1, Product Information, before performing any maintenance tasks.

� Maintaining MetriScan This section describes common maintenance tasks. Performing these tasks can reduce

operating problems, prolong system life, and reduce overall operating costs.

WARNING Many parts of MetriScan carry high voltages

Whenever MetriScan is plugged in, even if the power switch is off, potentially dangerous voltages (100 – 240 V ac) exist on the wiring and fuses between where the power cord enters the device and the power switch. When the device is plugged in and the power switch is turned on, potentially dangerous voltages exist on all electronic boards, wires, and cables located in the device.

Safety covers shield all of these parts. With the covers in place, it should be difficult to accidentally make contact with dangerous voltages. Regardless, you should perform no maintenance tasks with MetriScan power on or connected to its power source. To reduce the risk of electric shock, follow the maintenance procedures carefully.


None of the internal parts of MetriScan is user serviceable. As outlined in this chapter, the only user serviceable parts of the system do not require removal of the protective covers. The manufacturer must perform all other service. For assistance, contact your local distributor.

Do not use acetone or methylethylketone (MEK) to clean MetriScan

Use of acetone or MEK to clean MetriScan may result in damage to the unit’s exterior.

Do not immerse MetriScan or allow water to seep into the unit

Water and other liquids will damage the internal workings of the unit. Do not immerse MetriScan, and take care to prevent water ingress around the Hand Support Plate and keypads during cleaning.

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¾ Power off MetriScan as described in

Section 3.1 and disconnect the power cord from the back of the device.

¾ Locate the air filter assembly on the

back of MetriScan.

Air Filter

4.2 Cleaning the Air Filter Media

The air filter media should be cleaned every six months to a year, depending on the amount of airborne dust in the environment. In very dusty environments, you may need to clean the filter media more often.

Step 1

Step 2

Filter Media

Fan Guard

Do not remove

screws!

Media Retainer

¾ Using a small, flat tipped screwdriver, carefully separate the Media Retainer from the

Fan Guard. Do not remove the screws holding the Fan Guard to the back panel of MetriScan.

¾ Grasp the Filter Media with your hand and remove.

Step 3

Step 4

¾ Clean the Filter Media by rinsing it under cold running water. For best results, run the

water opposite to the direction of airflow through the filter.

¾ Squeeze excess water out of the filter and blot with a dry towel. Allow the Filter Media

to completely dry before re-installing.

¾ Insert the dry, cleaned filter onto the Fan Guard and snap the Media Retainer into

place to secure.

¾ Reconnect the power cord and power on MetriScan as outlined in Section 3.1.

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For additional air filters, contact your local distributor, or contact the filter manufacturer directly.

Manufacturer / Part No. Alara Part No. Description

Keystone / 8458 2602-0000 Plastic Fan Filter Assembly

WARNING

4.3 Replacing the Fuses

Use only fuses with the required current rating and of the specified type

Make sure that only fuses with the required current rating and of the specified type are used for replacement. The use of incorrect or makeshift fuses or the short-circuiting of fuse holders creates a shock hazard for the operator and patient.

For additional fuses, contact your local distributor, or contact the fuse manufacturer directly.

Manufacturer / Part No. Alara Part No. Description

Bussman / S505-2 5101-0005 5mm x 20mm fuses Littelfuse / 215002 5101-0005 5mm x 20mm fuses

Step 1

Step 2

Step 3

¾ Power off MetriScan as described in Section 3.1 and disconnect the power cord from

the back of the device.

¾ Insert a small, flat tipped screwdriver into

the top of the fuse cover on the back of MetriScan.

¾ Pry the top of the fuse cover open.

¾ Remove the fuse holder and replace both

fuses.

Make sure that the new fuses meet the following specifications:

250 V 2 Amp Time Lag High Breaking Capacity

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Step 4 ¾ Insert the fuse holder into MetriScan and

close the fuse cover.

¾ Reconnect the power cord and power on

MetriScan as outlined in Section 3.1.

4.4 Cleaning MetriScan

If MetriScan becomes dirty or contaminated, clean as follows:

Step 1

Step 2

¾ Power off MetriScan as described in Section 3.1 and disconnect the power cord from

the back of the device.

¾ Wipe the outside surfaces of MetriScan with a soft cloth dampened with a mild, non-

abrasive cleaning solution. Do not use acetone or MEK to clean the device. A cold sterilant solution can be used for disinfecting the surfaces. Be careful not to allow running or dripping cleaning solutions to seep into MetriScan. DO NOT SPRAY OR SOAK THE DEVICE.

¾ Allow the surfaces to dry completely before proceeding.

Step 3 ¾ Reconnect the power cord and power on MetriScan as outlined in Section 3.1.

4.5 Maintaining the Printer

For maintenance of the printer, please refer to the manufacturer’s instructions.

4.6 Required Service

In order to maintain the highest level of performance, service is required after 8,000 exposures. When 7,000 exposures have been performed, the following message will be displayed when the system is turned on:

Your MetriScan is due for required maintenance within the number of scans shown below. Once this limit is reached, your MetriScan will no longer operate. Please contact your distributor or Alara at your earliest convenience to schedule maintenance.

Remaining Scans: XXXX

Recalibration must be performed by the factory or by an authorized service center. If recalibration is not performed before the 8,000 exposure limit is reached, MetriScan will be disabled.

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M E T R I S C A N R E F E R E N C E I N F O R M A T I O N

C H A P T E R 5

R E F E R E N C E I N F O R M A T I O N

5.1 Compliance to Standards

This device has been tested to and complies with the following safety standards:

EN 60601-1 Medical electrical equipment/General Requirements for Safety

EN 60601-1-1 Additional requirements for medical electrical systems

EN 60601-1-2 Medical electrical equipment - electromagnetic compatibility requirements and tests

EN 60601-1-3 Radiation protection in Diagnostic X-ray Equipment

EN 60601-1-4 Medical electrical equipment - requirements for programmable electrical medical systems

EN 60601-2-7 Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-Ray Generators

EN 60601-2-28 Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis

EN 60825-1 Radiation safety of laser products

CSA C22.2 601 Medical Electrical Equipment – Part 1: General Requirements for Safety

UL 2601 Medical Electrical Equipment – Part 1: General Requirements for Safety

21 CFR Chapter I Subchapter J: FDA Radiological Health requirements (except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007)

GB 9706.1 Guao Biao Technical Standards for CCIB/CCC certification



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5.2 Disposal of Waste Materials and Inoperative Parts

If you own the MetriScan, it is highly recommended that you return the device to your local distributor for proper handling. If you choose instead to dispose of the device directly, please dispose of materials responsibly. Disposal regulations vary from country to country. Therefore, it is difficult to give specific instructions on the disposal of MetriScan waste material and inoperative parts. In general, we believe the following guidelines to be true:

Material Items Recycle? Comments

Plastic Enclosure, scan frame

Yes Remove all non- plastic items before recycling.

Metals (except lead)

Back Panel

Yes Remove all non-metal parts before recycling

Storage Phosphor

Imaging Plate

No

Contains barium, which may be regulated. Contact your local agency for more information and instructions on disposal of materials containing barium.

Lead

X-ray Shielding

Yes

Hazardous material; deliver to an appropriate disposal or recycling facility in compliance with local regulations.

X-ray Source Assembly (Monoblock)

N/A Contains hazardous material; return to Alara, Inc. for proper handling.

Other Materials

All Others

No

All other materials may be landfilled.

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5.3 Glossary

Bone Mass The total amount of bone in the body.

Bone Mineral Density (BMD) The quantity calculated by dividing the measured bone mineral content by the measured bone area in a densitometry study. The bone mineral density carries units of mass per area and is most often compared to reference population values.

Coefficient of Variation (CV) The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

s 1 ⎡ n

1

(X − X )2 ⎤ 2

Cv = = ⎢∑ i ⎥

where

X X ⎢ ⎣ i =1

n − 1 ⎥ ⎦

s = Estimated standard deviation of the population.

X = Mean value of observations in sample.

Xi = ith observation sampled.

n = Number of observations sampled.

Dose Absorbed dose as defined by International Commission on Radiation Units and Measurements. Absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted by ionizing radiation to matter of mass dm.

Dose Equivalent The product of the absorbed dose (D) (in rad or gray) in tissue, a quality factor (Q), and all other modifying factors (N). Dose equivalent is expressed in units of rem (or sievert) (1 rem = 0.01 sievert).

Effective Dose Equivalent The summation of the products of the dose equivalent received by specified tissues of the body (HT) and the appropriate weighting factors (WT) - that is (HE = äWTHT). It includes the dose from radiation sources internal and/or external to the body. The effective dose equivalent is expressed in units of rem (or sievert).

Leakage Radiation Radiation emanating from the diagnostic source assembly [tube housing assy with beam-limiting device attached] except for:

(1) The useful beam; and

(2) Radiation produced when the exposure switch or timer is not activated

Precision The capability of the device to repeat or reproduce the same results on subsequent or repeated trials. Precision is often expressed as the coefficient of variation (CV%). Precision may be expressed based on the sources of variation included. The most common are:

• Machine-only precision: consistency among repeated measurements on a single phantom, without repositioning, under conditions that are as close to identical as possible.

• Repositioning: variation in measurements on phantoms or subjects introduced through changes in positioning.

• In-vivo, clinical, or patient precision: precision measured in a clinical setting including variations due to patient and operator differences.

Regions of Interest The area of the phalanges identified by MetriScan and used to estimate relative BMD. The

regions of interest for MetriScan defined by the white outlines in the displayed image should be the middle bones of the 2

nd, 3

rd and 4

th fingers.

T-score The number of standard deviations a patient’s estimated BMD value is away from the normative mean BMD estimate.

Z-score The Z-score is calculated based on the mean and standard deviation of an age-matched reference database for which the gender and ethnicity match those of the patient.

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5.4 Reference Database

This table defines the reference database used to calculate the T- and Z-Scores based on patient ethnicity and gender:

Patient Ethnicity

Patient Gender

Reference Database for:

T-Score

Z-Score

Asian

Female

Asian Female

Z-Score available ages 10-89

Asian

Male

Asian Male


Caucasian

Female

Caucasian Female


All Others

Caucasian Female

N/A

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5.5 EMC – Guidance and Manufacturer’s Declaration

Per IEC 60601-1-2:2001

Guidance and manufacturer’s declaration – electromagnetic emissions The MetriScan is intended for use in the electromagnetic environment specified below. The customer or the user of the MetriScan should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The MetriScan uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to

cause any interference in nearby electronic equipment. RF emissions

CISPR 11

Class A

The MetriScan is suitable for use in all establishments other than

domestic and those directly connected to the public low-voltage

power supply network that supplies building used for domestic

purposes.

Harmonic emissions IEC 61000-3-2

Class D

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Complies

Recommended separation distances between

portable and mobile RF communications equipment and the MetriScan The MetriScan is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MetriScan can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and

the MetriScan as recommended below, according to the maximum output power of the communications

equipment.

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter

m 150 kHz to 80 MHz

d = 1.2 P

80 MHz to 800 MHz

d = 1.2 P

800 MHz to 2.5 GHz

d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3

100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)

can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

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Guidance and manufacturer’s declaration – electromagnetic immunity The MetriScan is intended for use in the electromagnetic environment specified below. The customer or the user of the MetriScan should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level Electromagnetic environment -

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with

synthetic material, the relative

humidity should be at least 30% Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

±1 kV for input/output lines

Mains power quality should be that of

a typical commercial or hospital

environment.

Surge

IEC 61000-4-5 ±1 kV line(s) to line(s)

±2 kV line(s) to earth

±1 kV line(s) to line(s)

±2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital

environment. Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

<5% UT

(>95% dip in UT ) for 0.5 cycle

40% UT

(60% dip in UT ) for 5 cycles

70% U

(30% dip in UT )

for 25 cycles <5% UT

(>95% dip in UT ) for 5 sec

40% UT

(60% dip in UT ) for 100 ms

70% U

(30% dip in UT )

for 10 ms <5% UT

(>95% dip in UT ) for 5 sec

Mains power quality should be that of

a typical commercial or hospital

environment. If the user of the

MetriScan required continued

operation during power mains

interruptions, it is recommended that

the MetriScan be powered from an

uninterruptible power supply or

battery.

Power frequency (50/60 Hz) magnetic

field

IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a

typical commercial or hospital

environment. NOTE UT is the a.c. mains voltage prior to application of the test level.

T T

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Guidance and manufacturer’s declaration – electromagnetic immunity

The MetriScan is intended for use in the electromagnetic environment specified below. The customer or the user of the MetriScan should assure that it is used in such an environment.

Immunity test IEC 60601 test

level Compliance

level Electromagnetic environment – guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be

used no closer to any part of the MetriScan, including cables, than the recommended separation distance

calculated from the equation applicable to the frequency

of the transmitter.

Recommended separation distance

d = 1.2 P

d = 1.2 P 80 MHz to 800 MHz

d = 2.3 P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter

in watts (W) according to the transmitter manufacturer and d is

the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by

an electromagnetic site survey,a

should be less than the

compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked

with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theorectically

with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site

survey should be considered. If the measured field strength in the location in which the MetriScan is used

exceeds the applicable RF compliance level above, the MetriScan should be observed to verify normal operation.

If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MetriScan.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Manual Assy Number: 500-1203-01 Rev D

©2008 Alara, Inc.

MetriScan and Alara are registered trademarks of Alara, Inc.

U.S. Patent Numbers 6,490,339: 6,510,197 In addition to the Alara Trademarks, other brand and product names are or may be trademarks or registered

trademarks of their respective holders. All rights with respect to those trademarks or registered trademarks are

reserved by their respective holders.

This manual was originally drafted, approved and supplied by Alara, Inc., in the English Language.

Document Number: 203-0199-04 Rev C

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