OnPoint 1.2mm Scope System Operation and Care Manual Rev C

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OnPoint™

1.2mm Scope System

Operation and Care Manual

Manufactured for

Manufactured by BioVision Technologies, LLC

Anticipate. Innovate.

TM

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Operation and Care Manual

Table of Contents

3.1.5.15

3.1.5.16

3.1.5.17

3.1.5.18

3.2

Basic Usage

3.2.1

Setup for Each Procedure

3.2.2

Power-Down Procedures

3.2.3

Single-use Endoscope Disposal

4.0

4.1

4.2

4.3

4.4

4.5

5.0

VGA Gamma Set Up

Print File Format

Capture Mode Set Up

Video Output Test

Cleaning and Maintenance

Cleaning of OnPoint™ System

Sterilization of OnPoint™

Lamp Life Monitoring and Replacement

Recommendations for the Disposal of the Device

Fuse Replacement

Troubleshooting

IMPORTANT

The OnPoint™ 1.2mm Scope System is indicated to provide illumination

and visualization of anatomy in an interior cavity of the body through a

natural or surgical opening. This device is indicated for diagnostic and

operative arthroscopic and endoscopic procedures. The device is to be

used by a trained physician for the indicated uses only.

This manual describes the recommended procedures for preparing and

operating the OnPoint System. It does not describe how any medical

procedure is to be performed on a patient with this instrument.

Read all instructions in this manual carefully before using the OnPoint

1.2mm Scope System.

Carefully follow all safety instructions to prevent injury to the user or patient,

fire hazards, electrical shock, and damage to the device.

To maintain this device in optimal condition, follow all recommendations

in this manual for handling, cleaning, and storage.

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OnPoint™ Scope System

1.0 Introduction

Thank you for your purchase of the OnPoint™1.2mm Scope System. This piece

of equipment is designed and built to give you the latest technology and

the best performance. This manual will help you make the most of your

equipment investment.

1.1 The OnPoint™ 1.2mm Scope System

The OnPoint system combines several essential surgical requirements into

a single compact & portable package:

Xenon Fiber Optic Light Source

By employing state-of-the-art lamp power supply technology, a proprietary

xenon arc lamp incorporates an enhanced reflector and delivers near

175-watt illumination performance for outstanding image quality.

Proprietary High-Resolution Camera System

The OnPoint camera is a high-resolution 480-line digital camera. It uses a

quick-release optical connector that adapts to a wide variety of surgical

endoscopes. A proprietary single cable design eliminates the complexity

and cost of the traditional dual-cable system approach.

Integrated Video Display with Multiple Outputs

The OnPoint high-resolution 6.4” LCD monitor combines the performance

of the Xenon Fiber Optic Light Source and High Resolution Camera System

to deliver a brilliant, high-resolution video image for clear detail recognition

and outstanding color reproduction.

Multiple Output options on the OnPoint unit allow you to connect larger

external video monitors, video printers, and video recording devices.

MediaCaptureUSB

A full-featured, fully-integrated image capture system is included in every

OnPoint system. Every OnPoint has the capability to capture video, still

images, full-resolution video, and audio-tagged still images. Using the

popular CompactFlash® media format, MediaCaptureUSB enables users

to quickly and conveniently document their procedures. Connect directly

to a computer via USB and use the OnPoint to browse captured media

or capture still images and video directly to your practice management

software, running on Windows 2000 or Windows XP.

Camera System: CMAR-01

High-Resolution endoscopic/arthroscopic camera system with integrated

light cable and MediaCaptureUSB capture button.

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Operation and Care Manual

1.2 Indications for Use

The OnPoint 1.2mm Scope System is indicated to be used by a trained

physician to provide illumination and visualization of an interior cavity of

the body through a natural or surgical opening in diagnostic and operative

arthroscopic and endoscopic procedures.

1.3 Contraindications

The OnPoint 1.2mm Scope System is contraindicated for use in applications

where high intensity light might damage tissue, such as neonate

transillumination and ophthalmic procedures. For other contraindications,

consult the literature accompanying the instrumentation utilized with this

device.

1.4 Regulatory Compliance

The OnPoint 1.2mm Scope System complies with all regulations to be

marketed in the United States of America, Canada, and the European Union.

This device complies with EN60601-1 and all collateral standards.

This device complies with part 15 of the FCC rules.

This device complies with the Medical Device Directive (Council Directive

93/42/EEC).

Federal law restricts this device to sale by or on order of a physician

licensed by the law of the state in which he practices to use or order the

use of this device.

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OnPoint™ Scope System

1.4.1 Electromagnetic Compatibility (IEC 60601-1-2)

Guidance and Manufacturer’s Declaration- Electromagnetic Emissions

The OnPoint™ is intended for use in the electromagnetic environment specified below. The customer or the user of the OnPoint™

should assure that it is used in such an environment.

Emissions Test

Compliance Electromagnetic Environment - Guidance

RF Emissions

Group 1

OnPoint™ 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.

CISPR 11

RF Emissions

Class B

The OnPoint™ is suitable for use in all establishments other than domestic and those directly

CISPR 11

connected to the public low-voltage power supply network that supplies buildings used for

Harmonic Emissions

Class A

domestic purposes.

IEC 61000-3-2

Voltage Fluctuations / Complies

Flicker Emissions

IEC 61000-3-3

Guidance and Manufacturer’s Declaration- Electromagnetic Immunity

The OnPoint™ is intended for use in the electromagnetic environment specified below. The customer or the user of the OnPoint™

should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic

+ 6 kV contact

+ 6 kV contact

Floors should be wood, concrete or ceramic tile.

Discharge (ESD)

If floors are covered with synthetic material, the

IEC 61000-4-2

+ 8 kV air

+ 8 kV air

relative humidity should be at least 30%.

Electrical Fast

+ 2 kV for power supply lines

+ 2 kV for power supply Mains power quality should be that of a typical

Transient/Burst

+1 kV for input/output lines

lines

commercial or hospital environment.

IEC 61000-4-4

+1 kV for input/output

lines

Voltage Dips, short <5% UT(>95% dip in UT for 0,5 cycle 100% dip for 0.5 cycles Mains power quality should be that of a typical

interruptions and 40% UT (60% dip in UT) for 5 cycles 60% dip for 5 cycles

commercial of hospital environment. If the user

voltage variations 70% UT(30% dip in UT) for 25 cycles 30% dip for 25 cycles

of the OnPoint™ requires continued operation

on power supply <5% UT(>95% dip in UT) for 5 sec.

100% dip for 5 seconds during power mains interruptions, it is

input lines.

recommended that the OnPoint™ be powered

IEC 61000-4-11

from an uninterruptible power supply or a battery.

Power Frequency 3 A/m

3 A/m

Power frequency magnetic fields should be at

(50/60Hz) magnetlevels characteristic of a typical location in a

ic field

typical commercial or hospital environment.

IEC 61000-4-8

NOTE: UT is the ac mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration- Electromagnetic Immunity

The OnPoint™ is intended for use in the electromagnetic environment specified below. The customer or the user of the OnPoint™

should assure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part

Conducted RF 3 V rms

10 V rms

of the OnPoint™ including cables, than the recommended separation distance calculated

IEC 61000-4-6 150 kHz to 80 MHz

from the equation applicable to the frequency of the transmitter.

outside of ISM bands

Recommended separation distance

10 V/m

Radiated RF

d = (3.5/3) P

IEC 61000-4-3 10Vrms

d = (3.5/3) P 80 MHz to 800 MHZ

d = (7/3) P 800 MHz to 2.5 GHz

150 kHz to 80 MHz

Where P is the maximum output power rating of the transmitter in watts (W) according to

in ISM bands

10 V/m

80 MHZ to 2.5 GHz

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 range b.

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 radios, AM and FM radio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in which the Xe3000 is used exceeds the applicable RF compliance level

above, the OnPoint™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OnPoint™.

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

Recommended separation distances between portable and mobile RF communications equipment

and the OnPointTM

The OnPoint™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the OnPoint™

can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and

the OnPoint™ as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter (W)

0.01

0.1

1

10

100

Separation distance according to frequency of transmitter

150kHz to 80MHz

80MHz to 800MHz

800MHz to 2.5GHz

0.035

0.035

0.07

0.11

0.11

0.22

0.35

0.35

0.7

1.12

1.12

2.21

3.5

3.5

7

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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Operation and Care Manual

1.5 Warranty Information

When delivered to the end user in new condition in the original container,

the OnPoint 1.2mm Scope system is warranted to be free from defects in

material or workmanship for one year from the date of shipment from

Biomet Microfixation to the end user.

Within the above listed time periods, parts that are returned, freight prepaid,

to Biomet Microfixation and are determined by Biomet Microfixation to be

defective will be repaired or replaced by BioVision Technologies without

charge for parts, labor, or return ground shipping costs. Biomet Microfixation

will make every effort to accomplish this repair or replacement within a

reasonable time. After the warranty period, the purchaser must pay all

charges for repair and replacement. This warranty does not cover products

intended for single patient use beyond the initial use or consumable items.

The above actions by Biomet Microfixation shall constitute your exclusive

remedy and Biomet Microfixation’s sole obligation under this warranty.

Biomet Microfixation shall not be responsible for warranty claims made

after the warranty period. To obtain warranty repair service, you must

contact Biomet Microfixation to obtain a Return Material Authorization

(“RMA”) number, then return the product, freight prepaid, to Biomet

Microfixation. The RMA number and a complete explanation of the

problem must be included with the product being returned to Biomet

Microfixation for warranty service. The product to be repaired must be

returned in its original box and packaging, or a similar box and packaging

affording an equivalent degree of protection. Upon completion of repairs,

Biomet Microfixation will return the product to the end user, freight prepaid.

The warranty period for replacement parts shall begin upon shipment of

same, but shall in no event exceed the warranty period of the defective

part. Biomet Microfixation shall have no liability or obligation for a product

that has been subjected to any of the following:

Failure caused by or attributable to Acts of God, improper use, abuse,

negligent care or handling, accident, faulty installation, improper

cleaning, improper maintenance, or other indications of excess voltage.

This warranty is also void if the product has been repaired or modified

without prior written authorization from Biomet Microfixation, if the end-user

has failed to follow the instructions or heed the warnings or specifications

in the Operation and Care Manual, or if the product’s serial number has

been altered or removed.

EXCEPT FOR THE FOREGOING WARRANTIES, BIOMET MICROFIXATION HEREBY DISCLAIMS AND

EXCLUDES ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO

ANY AND/OR ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR

PURPOSE. BIOMET MICROFIXATION HEREBY DISCLAIMS ANY REPRESENTATIONS OR WARRANTY

THAT THIS PRODUCT OR ANY OF ITS PARTS IS COMPATIBLE WITH NON-BIOMET MICROFIXATION

PRODUCTS OTHER THAN VIDEO EQUIPMENT ATTACHED TO ITS VIDEO OUTPUTS, AS DESCRIBED

IN THE OPERATOR’S MANUAL. THE LIABILITY OF BIOMET MICROFIXATION, IF ANY,

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OnPoint™ Scope System

AND PURCHASER’S SOLE AND EXCLUSIVE REMEDY FOR DAMAGES FOR ANY CLAIM OF ANY KIND

WHATSOEVER, REGARDLESS OF THE LEGAL THEORY, SHALL NOT BE GREATER IN AMOUNT THAN

THE PURCHASE PRICE OF THE PRODUCT SOLD BY BioVision TECHNOLOGIES THAT CAUSED

ANY ALLEGED DAMAGE. IN NO EVENT SHALL BIOMET MICROFIXATION BE LIABLE TO PURCHASER

FOR ANY SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND.

Contact Biomet Microfixation for warranty information

904.741.4400 • 800.874.7711

www.biometmicrofixation.com

Distributed by Biomet Microfixation

1.6 How to Use This Manual

The intention of this document is to convey the proper and prescribed

operation and care of the OnPoint™ 1.2mm Scope System.

1.7 Manual Conventions

This manual adheres to a set of conventions to help you easily find the

information you need and inform you of important information that will

help you efficiently and effectively use your equipment.

Sections and sub-sections are noted as follows:

1.0 Section Title

1.1 Sub-section title

Special and important information is called out using notes and warnings.

Notes usually pertain to a recommended protocol that will help extend

the life of your equipment. Warnings pertain to protocols that delineate

appropriate actions which maintain a safe and healthy work environment.

Notes and warnings are called out in the following manners:

Note: This is a note.

WARNING: This is a warning.

1.8 List of Symbols (used in this manual and product labels)

Hazard Warning.

7

Type BF

Applied Part

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Operation and Care Manual

Not Protected Against the

Ingress of Water

Attention: Read Operating Manual

for Warnings, Precautions, and

Instructions for Use.

Caution - Hot

Caution - High Voltage

Alternating Current

Fuse

European CE Mark

PRODUCT SERVICE

Date of Manufacturing

Storage Humidity

TUV, Nationally Recognized Testing

Laboratory (NRTL) Mark

Federal Communications

Commission Mark

Transport Temperature

2.0 Product Specifications

The following section describes the components and features of the

OnPoint™ system.

2.1 Contents

The following components are included in your OnPoint system:

OnPoint™Integrated Visualization System (Base Unit)

Medical Grade Power Cord

Operation and Care Manual

Check to see that you have all of these components before proceeding.

If any of these components are missing, contact Biomet Microfixation

immediately using the contact information below:

Biomet Microfixation

1520 Tradeport Drive

Jacksonville, FL 32218-2480

Phone: 800.874.7711 or 904.741.4400

www.biometmicrofixation.com

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OnPoint™ Scope System

2.2 Features and Specifications

2.2.1 OnPoint Features

CompactFlash ® Media Slot

KEYPAD

Integrated

LCD Monitor

Mode

Delete

Microphone

Left Select

PS2 Keyboard

Connection

Right Select

Stop/Enter

USB Connection

Power Indicator

Power Button

Speaker

Ventilation

Exhaust

Camera Connector/Light port

Rear

Ventilation

Exhaust

VR Connector

Composite Video

Fuse Holder

S-Video

9

Power

Connector

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Operation and Care Manual

Handpiece

Camera POD

Camera

Handpiece

Camera

Connector

Fiber-optic cable

Focus Knob

Scope

Coupler

Image Capture

Button

Scope

Cannula

Sliding Sleeve

Coupler

Alignment Dot

Scope

Cannula Luer Fitting

Scope Probe/Cannula

Scope Handle

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OnPoint™ Scope System

2.2.2 Technical Specifications

Electrical

Input voltage:

Input current:

Power connector:

Classification:

Mode of operation:

Fuse:

120/230VAC, 50/60Hz

3.0/1.5A maximum.

IEC 320

IEC60601-1 Class I, Type BF equipment

Continuous

3.15A 250V Type F

Environmental

Operating altitude:

Operating temperature:

Operating humidity:

Storage/transport altitude:

Storage/transport temperature:

Storage/transport humidity:

-304.8 to 3657.6m(-1000 to 12000 ft) MSL.

0ºC to 40ºC (-32ºF to 104ºF).

0% to 95% RH, non-condensing.

-304.8 to 10668m (-1000 to 35000 ft) MSL.

0ºC to 50ºC (-32ºF to 122ºF).

0% to 95% RH, non-condensing.

Video / Display

Input video format:

Video output 1:

Video output 2:

Video output 3:

NTSC Composite, 75Ω, 1Vp-p.

NTSC Composite, 75Ω, BNC.

NTSC Y/C, 75Ω, 4-pin circular DIN.

NTSC Composite, 75Ω, 4-pin VR glasses

connector.

Display type:

LCD 16.25 cm (6.4 in) TFT,

active matrix (960Hx 234V)

Light Source

Type:

Lamp:

Power:

Xenon Arc

BL35WXe

35W

MediaCaptureUSB

Storage media:

Still image file format:

Still image size:

Video file format:

Video size/fram rate:

CompactFlash®

JPEG

640x480 pixels.

AVI (MJPEG codec)

640x480 pixels/30fps.

Compatible Camera Attachments

Needlescope:

24-3000

2.3 Safety Information

General requirements for the safe use of the device:

• It is important that you read, understand, and comply with all of the

following safety precautions, markings, labeling, and all accompanying

literature.

• Failure to follow these precautions could result in injury to the patient or

user, or damage to the OnPoint™ unit.

• When used in the presence of other energized, endoscopically-used

devices and accessories, such as Lasers and High Frequency Surgical

equipment, the safety precautions for such equipment must also be

followed.

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Operation and Care Manual

• Before each use, check the outer surface of the arthroscope and

arthroscopic accessories to ensure there are no unintended rough surfaces,

sharp edges, or protrusions that may cause a safety hazard to the patient

or user; or cause damage to the equipment and other accessories.

• In the event of use with other surgical tools, such as shavers, care shall be

taken to avoid damage to the arthroscope or any arthroscopic

accessories. All damaged instruments shall be discarded immediately.

• In the event of a loss of system function during a procedure, no further

visualization is necessary, and the procedure is ended, the physician shall

remove the arthroscope and proceed with closure or further patient care

as needed. Further arthroscopic examination shall only be performed with

a fully functional system, for which a backup unit is recommended.

To avoid personal injury and damage to this device:

• Do not block ventilation slots or openings. Always ensure sufficient

clearance for ventilation by not placing any other equipment or objects

on or near the vents on either side of the OnPoint™ unit.

• Always place and keep the OnPoint unit on a flat, level, and secure

surface.

• In the event of suspected damage or failure, DO NOT OPERATE and have

the device inspected by qualified personnel.

Sufficient clearance is

maintained by allowing

an area six inches by six

inches both behind and

on the left side of the

OnPoint™ unit.

Ventilation

Clearance

6x6 inches

Ventilation

Clearance

6x6 inches

A flat surface will provide the optimal

performance.

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OnPoint™ Scope System

To avoid fire hazard and electrical shock:

• Do not operate the device outside of the specified input voltage range.

• Only use medical-grade power cords with the OnPoint™ system.

• Connect to a properly grounded hospital-grade outlet only.

• Use only the fuse type and rating specified for this device.

• DO NOT operate the OnPoint™ system in an explosive atmosphere (e.g. in the presence

of flammable anesthetics, etc.).

• The OnPoint™ unit does not have any field-replaceable parts. DO NOT disassemble or

open the front cover or any other covers or panels. Opening the front cover will void the

manufacturer’s warranty.

• Do not operate this product if there are signs of tampering or any of the covers are removed.

• Do not allow foreign objects inside of the device.

• Before performing any kind of maintenance (e.g. cleaning the OnPoint™ system,

replacing fuses, etc.), always perform the following:

 Unplug the power cord.

 Allow unit to cool for at least ten (10) minutes after turning off.

• Do not allow spilling of liquids on the OnPoint™ unit.

• Do not immerse any of the components in liquids.

• Do not operate in wet or damp conditions.

• If any maintenance or repair is needed beyond superficial cleaning or replacing fuses,

contact Biomet Microfixation or your authorized service representative.

Always unplug the power cord if:

• The device has been exposed to moisture, liquids has been spilled on the device, the

device or any of its components have been soaked or immersed in liquids.

• The device has been dropped.

• The device does not operate properly, the device does not turn on, or the performance

of the device is noticeably different.

• The device displays signs of tampering or damage, such as damage to the power cord,

broken enclosures, etc.

WARNING: In the event of use with other energized endoscopically-used instruments

and accessories, the PATIENT LEAKAGE currents may be additive.

WARNING: Possible explosion if used in the presence of FLAMMABLE ANESTHETICS or

other EXPLOSIVE GAS MIXTURES.

WARNING: This device is not intended to be used in the presence of HIGH FREQUENCY

SURGICAL EQUIPMENT.

WARNING: This device is not intended to be used in the presence of LASER EQUIPMENT.

WARNING: Awareness of the possibility of a gas embolism whenever compressed

gases are used in a patient procedure. To minimize the risk, you must verify that

adequate space exists for the egress of any patient applied gases.

WARNING: USB connector is never to be used when the device is in contact with a

patient.

WARNING: The lamp and reflector are not intended for field replacement. Attempts

to service or replace the lamp may result in injury or damage to the device, and void

the warranty.

WARNING: Do not look directly into the light emitting windows of the endoscope

or handpiece. This may result in eye damage.

WARNING: After removing the endoscope, do not touch the light emitting

window of the handpiece or the light receiving window of the endoscope.

They may become hot after long periods of use.

WARNING: Do not touch the light receiving port of the handpiece upon

disconnection. The tip of the port may become hot after long periods of use.

WARNING: DO NOT IMMERSE the camera handpiece in liquids of any kind, personal

injury or damage to the device may result.

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Operation and Care Manual

To avoid electromagnetic interference:

• Special precautions are required regarding the electromagnetic compatibility (EMC) of

the OnPoint™ system. The system needs to be installed and put into service according

to the EMC information provided in this manual.

• Portable and mobile radio frequency (RF) communications equipment can affect any

medical electrical equipment including the system.

• Only cables and accessories provided by the manufacturer may be used with the

system. The use of any other cables or accessories may have an adverse effect in the

electroagnetic compatibility of the device such as increased emissions or decreased

immunity.

• This device should not be used adjacent to or stacked with other equipment. Should use

adjacent to other equipment become necessary the system should be observed to

verify normal operation in that configuration.

“Additional equipment connected to medical electrical equipment must comply with the

respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, all

configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1

or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment

to medical electrical equipment configures a medical system and is therefore responsible that

the system complies with the requirements for medical electrical systems. Attention is drawn to

the fact that local laws take priority over the above mentioned requirements. If in doubt, consult

your local representative or the technical service department.”

“Zusätzliche Geräte, die an medizinische elektrische Geräte angeschlossen werden, müssen

nachweisbar ihren entsprechenden IEC oder ISO Normen entsprechen (z.B. IEC 60950 für

datenverarbeitende Geräte). Weiterhin müssen alle Konfigurationen den normativen

Anforderungen für medizinische Systeme entsprechen (siehe IEC 60601-1-1 oder Abschnitt 16 der

3. Ausgabe der IEC 60601-1, jeweilig). Wer zusätzliche Geräte an medizinische elektrische Geräte

anschließt ist Systemkonfigurierer und ist damit verantwortlich, dass das System mit den

normativen Anforderungen für Systeme übereinstimmt. Es wird darauf hingewiesen, dass

lokale Gesetze gegenüber obigen normativen Anforderungen Vorrang haben. Bei Rückfragen

kontaktieren Sie bitte Ihren örtlichen Fachhändler oder den Technischen Dienst.”

3.0 Setup and Basic Usage

The following section describes how to set up

and use the OnPoint™ system for surgical

procedures.

3.1 Setup

Proper initial setup is essential to provide you

and your staff the best access to operational

and visual performance while conducting

procedures.

Adjust display up/down for

Optimal Viewing Angle

3.1.1 OnPoint System

For best performance, always operate and

keep the OnPoint unit on a flat, level, and

secure surface. Images on the Integrated

Video Display are best viewed at an angle

perpendicular to the display.

Do not tilt the OnPoint unit. For better viewing,

adjust the height and display angle.

Swivel display side-to-side

for Optimal Viewing Angle

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OnPoint™ Scope System

3.1.2 Attaching a Camera Handpiece and Arthroscope

The OnPoint camera handpieces attach via a combination fiberoptic/

electric connector. This connector seats in the receptacle on the front of

the unit (See also: § 2.2.1 Front).

Before connecting a camera or handpiece to the OnPoint™ unit, the camera or

handpiece must be properly cleaned (Ref. Section 4.0).

Note: For best image quality and to ensure patient safety, verify that both ends of the camera

or handpiece are free of foreign particles.

Connect the scope to the camera

by pulling the sliding sleeve and

inserting the scope. Ensure that the

light port is aligned with the bottom

of the handpiece and the red dot

on the back of the scope lines up

with the coupler top-indicator.

Release the sliding sleeve to secure

the scope in place. The proper

technique must be utilized in order

to preserve the sterile field through

the drape that is attached to the

endoscope.

Pull Sliding

Sleeve

Drape

(Sectioned for illustration purposes)

Turn the power on. The monitor will power up within about fifteen (15)

seconds. Hold the distal tip of the scope approximately 2.0cm from a

surface with fine details such as your palm or surgical drape.

Turn the focus adjustment knob in either direction until the fine-detailed

surface at the distal end of the scope comes into optimal focus on the LCD

video monitor.

See also: § 3.2.2 Setup for Each Procedure

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Operation and Care Manual

3.1.3 Attaching External Video Devices

In some cases, you may need a larger display than what is provided by the

OnPoint™ Integrated Video Display. For this reason, the OnPoint unit has

connections for multiple video outputs.

The OnPoint can be connected to a standard video monitor or an S-Video

monitor, or both. Consult your monitor manual for the corresponding

connections.

BNC to RCA Adapter (included)

RCS Cable (not included)

S-Video Cable

(not included)

BNC Cable (not included)

TV monitor

To make these connections, plug the connecting cable(s) into the video

output(s) on the rear of the OnPoint™ and the corresponding video input(s)

of the external devices.

A BNC-to-RCA adapter is supplied with the OnPoint for use with an RCA

cable, so that such connections can be made with an RCA cable as well

as a BNC cable. The adapter allows an RCA cable to be plugged into the

BNC video output on the rear of the OnPoint video box.

Note: The S-Video connector on the back of the OnPoint is rotated 45 degrees to the left. Most

S-Video cables have an arrow on the connectors to indicate the “top” of the connector. Finding

this arrow and rotating it to the left will help when connecting this type of cable to the OnPoint.

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The OnPoint™ can also be connected to a standard VCR/DVR. Consult your

VCR/DVR manual for the corresponding connections.

BNC to RCA Adapter

(included)

S-Video Cable

(not included)

RCS Cable

(not included)

BNC Cable

(not included)

VCR/DVR

The OnPoint can also be connected to a standard camcorder. Consult

your camcorder manual for the corresponding connections.

BNC to RCA Adapter

(included)

RCS Cable

(not included)

BNC Cable

(not included)

Camcorder

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S-Video Cable

(not included)

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3.1.4 Attaching Virtual Reality Glasses

1. To attach the iWear VR glasses, simply take the connector on the end of

the glasses and find the 6-pin connector on the back of the OnPoint™.

2. To disconnect the iWear VR glasses, pull the knurled ring on the glasses

connector directly away from the OnPoint unit. The ring will move and

the connector will disconnect.

iWear VR Glasses Connector

There is a little red dot on the cable connector and the receptacle. When these are aligned, the

plug can be inserted into the receptacle.

3.1.5 Setting Up and Operating MediaCaptureUSB

The MediaCaptureUSB is a full-featured, fully integrated image-capture

system that is included with every OnPoint™ system. MediaCaptureUSB is also

able to be activated from the sterile field via the camera connected to the

system. Your hand never has to leave the camera to capture what you

need.

Note: All functions that appear on the OnPoint display are also projected on any external display

(e.g. computer monitor, BioVision VR glasses, etc.).

3.1.5.1 Modes

The MediaCaptureUSB has three separate modes of operation:

1. Still Capture Mode – for capturing still images (“pictures”)

2. Video Capture Mode – for capturing video images (“movies”)

3. Image/Video Review Mode (or “Review Mode”) – for reviewing image

captures (available only if a CompactFlash® card is inserted in the

OnPoint™ system’s media slot, and the card already contains captured

media).

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Note: If you have audio tag recording enabled, you can also include audio with any still images

you capture. Refer to the Setup section for more information on audio tag recording. Audio tags

are always recorded with video image captures.

Note: The OnPoint system will beep every time you press a button on the MediaCaptureUSB panel

(just under the OnPoint display).

To move between the different modes – in the above order – press the Mode

button under the OnPoint™ display (or press the F5 key on your keyboard).

3.1.5.2 Accessories & Attachments

You can also connect different accessories to your OnPoint system:

Note: Refer to Section 2.2.1 for the location of connectors.

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If you have audio tag recording enabled with your image captures, audio

can be played back and heard from the OnPoint™ unit’s speaker.

If you want to add a Name & ID tag to a card, then you will need to connect

a PS/2 keyboard to the OnPoint system. To do this, insert the keyboard plug

into the keyboard jack on the left side of the OnPoint display.

Note: This connection does not support USB keyboards with PS/2 converters.

To connect the OnPoint system to a separate computer, insert the

appropriate USB plug into the USB jack on the left side of the OnPoint

display. Your computer will display “New Hardware Detected” (or similar)

messages as a result of this connection and you can view the files on your

CompactFlash® card through your computer (as well as directly from the

OnPoint system).

The MediaCaptureUSB software installation provides drivers that allow

Windows 2000 and XP systems to use the OnPoint system as a video source.

These drivers will also be available for other software on your system that is

aware of such multimedia devices. The “BioVision ViCAM III Utilities > ViCAM III

AMCAP” software (also included with this installation) provides a window

on your main computer monitor that mirrors the OnPoint display.

Note: If you have not already installed the MediaCaptureUSB software on the appropriate

computer, you will need to do so at this point:

Disable all virus protection software on this computer, and close any other programs that

may be running.

Locate the MediaCaptureUSB software, start the installation program (“install.exe”), and

follow the installation wizard’s instructions.

When the installation process is completed, restart your computer.

If you experience any problems with this process, check with your system administrator.

3.1.5.3 CompactFlash® Card

To begin capturing and reviewing images, insert a CompactFlash® (e.g.

SanDisk™, etc.) card into the media slot at the top of the OnPoint™ display

until it is fully seated.

Note: MediaCaptureUSB supports CompactFlash® Type I and Type II cards. Video capture will

benefit from faster cards such as SanDisk™ Ultra II or Extreme III series or comparable cards.

3.1.5.4 Entering Name and ID Stamping

If a Name & ID have already been entered for this card, they will appear

on the OnPoint display.

If you want to add or edit the Name & ID for this card, press the Esc key on

your keyboard (you will need to attach a keyboard to the OnPoint system,

as described in the “Connecting Accessories” section). The Name/ID Entry

Mode will appear on the OnPoint display.

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OnPoint™ Scope System

Note: All of these fields are upper case only.

The cursor initially sits in the Name field. Use your keyboard to enter a Name

(or edit the current Name). The name field allows a maximum of 15 characters

Press the Tab key to move to the ID field and enter (or edit) an ID.

When you are finished entering this information, press the Enter key on your

keyboard to accept it and exit this mode.

3.1.5.5 Capturing Images

Three ways to activate a capture on MediaCaptureUSB:

1. Press the Stop/Enter button under the OnPoint™ display.

2. Press the F9 key on the optional, attached keyboard.

3. Press the Capture button on your camera.

3.1.5.5a Still Capture Mode

Activate the capture for about one (1) second. The light above the Stop/

Enter button will blink once and the system will beep. The image that

appears on the OnPoint display at the time you press this button is the

image that will be captured. It will be saved on the card as a “JPEG (.JPG)”

graphics file. The file’s name will be based on the date & time it was

captured (e.g. “MM-DD-YY-HH-MM-SS.JPG”).

When you have finished with this image capture, the OnPoint system will

return to Still Capture Mode.

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If you want to immediately review this image capture, press the Mode button

(F5 key) twice to switch to Review Mode. The image you just captured should

appear highlighted in the upper-left corner of the thumbnail gallery with a

“STILL” label.

Note: To include an audio tag with this still-image capture, perform the image capture in the

following manner:

First, make sure that you have enabled audio tag recording (refer to the Setup section for

instructions on how to do this) and in the setup menu set capture mode to “single mode button”

Activate the capture for about three (3) seconds. The light above the Stop/Enter button will blink

once and the system will beep, as with a regular still-image capture.

Continue to hold down the Stop/Enter button (F9 key) until the light above the Stop/Enter

button turns on and stays on: this signifies the activation of audio tag recording. The screen will

display “AUDIO RECORDING”.

Speak clearly into (no more than ten (10) feet away from) the OnPoint system’s microphone to

have it properly record the audio tag, and then press the Stop/Enter, (F9 key) or the camera

button, until the light above the Stop/Enter button turns off, the system beeps again, and the

audio tag recording is saved on the card as a “Wave (.WAV)” audio file. The file’s name will be

based on the date & time the image was captured (e.g. “MM-DD-YY-HH-MM-SS.WAV”): please

note that both the still image file (.JPG) and the audio tag file (.WAV) will have the same name.

When you have finished with this image capture, the OnPoint system will return to Still Capture

Mode.

If you want to immediately review this image capture, press the Mode button (F5 key) twice to

switch to Review Mode. The image you just captured should appear highlighted in the upper-left

corner of the thumbnail gallery with an “AUDIO” label (representing a still-image capture with an

audio tag attached).

3.1.5.5b Video Capture Mode

Activate the capture for about one (1) second. The light above the Stop/

Enter button will turn on and stay on, and the system will beep. This signifies

the activation of video recording.

The length of this recording depends on the Recording Limit you specified

in the Setup:

If you chose the “10 Second Recording Limit” option, the recording will last

(and the light above the Stop/Enter button will remain on) for ten (10)

seconds.

If you chose the “No Recording Limit” option, the recording will last (and

the light above the Stop/Enter button will remain on) until you press the

Stop/Enter button again, or up to the file size limit (i.e. the amount of free

space remaining on the card, or 2 GB total).

Please refer to the Setup section for more information on the Recording

Limit option.

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Continue with the video capture, moving the camera as necessary:

Audio is always recorded with video-image captures. Speak clearly into (no

more than ten (10) feet away from) the OnPoint system’s microphone to

have it properly record the audio.

This video recording will be saved on the card as an “Audio-Visual (.AVI)”

video file. The file’s name will be based on the date & time it was captured

(e.g. “MM-DD-YY-HH-MM-SS.AVI”). When you have finished with this image

capture, the OnPoint™ system will return to Video Capture Mode.

If you want to immediately review this image capture, press the Mode

button (F5 key) twice to switch to Review Mode. The image you just

captured should appear highlighted in the upper-left corner of the thumbnail

gallery with a “VIDEO” label. Press the Stop/Enter button (F9 key) to review

the entire video file.

3.1.5.5c Reviewing Images

To switch from capturing images to reviewing them, press the Mode button

(or F5 key) until you are in Review Mode. A thumbnail gallery of the four (4)

most recent images you captured will appear on the OnPoint™ display with

STILL, VIDEO, or AUDIO labels.

Press the buttons (or F7 and F8 keys, respectively) to move back & forth

through the thumbnail gallery.

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To see a full-size display of the currently highlighted image, press the Stop/

Enter button (or the F9 key).

If this is a Still capture (with “STILL” on its thumbnail), it will appear in full on

the OnPoint™ display.

If this is an Audio-tagged Still capture (i.e. with “AUDIO” on its thumbnail),

the still-image capture will appear in full on the OnPoint display and the

audio tag will also be heard.

If this is a Video capture (i.e. with “VIDEO” on its thumbnail), then it will

appear and play in full on the OnPoint display.

To scroll through image captures while they are being displayed in full, press

the < Select or Select > buttons (or the F7 or F8 keys, respectively).

To return to the thumbnail gallery (displaying four (4) images at a time), press

the Stop/Enter button (F9 key) again.

To delete the currently highlighted image, press the Delete button (or the F6

key). The following menu will appear:

Remove Current Record – deletes the currently displayed image from the

card.

Remove All Records on Card – deletes all images from the card.

Press the < Select or Select > buttons (F7 or F8 keys) to highlight your Delete

choice, and then press the Delete button (F6 key). You will then be prompted

to confirm this deletion by pressing the Delete button (F6 key) one more

time. At this point you will see a “Record Deleted” confirmation message and

you will be returned to the Review Mode.

If you wish to cancel the delete process at any point, press the Stop/Enter

button (F9 key) to return to the Review Mode.

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