ACMI ICN CystoNephroscope User and service manual

REF NTSC/PAL/VGA: ICN-0564, ICN-0565

Invisio™ ICN Flexible CystoNephroscope

Operations and Technical Manual

ACMI Corporation

136 Turnpike Road • Southborough, MA 01772-2104 • USA

[phone] or [phone] • Fax: [phone] • www.acmicorp.com

Authorized European Representative: MDCI, Ltd.

Arundel House • 1 Liverpool Gardens • Worthing, West Sussex BN11 1SL • United Kingdom

™ Trademark of ACMI Corporation or its Subsidiaries in the U.S. and/or other countries of the world Printed in USA
© 2004 ACMI Corporation, All Rights Reserved U.S. Patent Nos. 5,938,588; 6,171,235; 6,475,140; 6,485,411; other patents pending

99-1089 REV 10 1104

Table of
Contents

Repair/Return/Warranty ...................................................................... 3

Warnings and Cautions ....................................................................... 4

Section 1.0 Unpacking and Initial Inspection .......................................... 5

Section 2.0 General Description and Intended Use ................................... 5

Section 3.0 Description of Components................................................. 6

Section 3.1

Section 3.2 Technical Specifications ....................................................... 6

Section 4.0 Operation ...................................................................... 7

Section 4.1

Section 4.2 Optical Field Inspection ........................................................ 7

Section 4.3 Deflection Controls ............................................................... 8

Section 4.4 Leakage Tester ...................................................................... 8

Section 4.5 A

Section 4.6 Rotating Working Channel/Irrigation Port............................. 9

Section 4.7 Strain Relief .......................................................................... 9

Section 4.8 Cable Compensation ............................................................. 9

Section 5.0 Procedure .................................................................... 10

Section 5.1 Working Channel ................................................................ 10

Section 5.2 White Balancing .................................................................. 10

Section 5.3 Focusing ............................................................................. 10

Section 5.4 Remote Head Button Setup ................................................ 10

Section 5.5 On-Screen-Display (OSD) System ...................................... 11

Section 5.6 OSD Options and Navigation .............................................. 11

Section 5.7 Inspection ........................................................................... 12

Section 6.0 Troubleshooting Guide ..................................................... 12

Section 6.1 Troubleshooting: Invisio ICN Flexible CystoNephroscope... 12

Section 6.2 Troubleshooting: Video Image ............................................ 13

Section 7.0 General Care................................................................. 14

Section 8.0 Maintenance ................................................................. 14

Section 8.1 Cleaning - Invisio ICN Flexible CystoNephroscope ............. 15

Section 8.2 Cleaning the Optics on the Invisio ICN Flexible

Section 8.3 Cleaning the Invisio ICN Connector and Receptacle ........... 15

Section 8.4 Cleaning the Invisio IDC Digital Controller .......................... 15

Section 8.5

Section 8.6 Autoclave Sterilization ........................................................ 15

Section 8.7 Ethylene Oxide Sterilization ................................................ 16

Section 8.8 STERIS SYSTEM 1™ Sterilization ........................................ 16

Section 8.9 STERRAD® Sterilization ...................................................... 16

Section 9.0 Storage ....................................................................... 16

Section 10.0 Theory of Operation ........................................................ 16

Section 10.1 General ............................................................................... 16

Invisio ICN Flexible CystoNephroscope & Accessories ..............

Inspection of Invisio ICN Flexible CystoNephroscope ..............

UTOSEAL Feature ................................................................... 9

CystoNephroscope ............................................................. 15

Disinfection - Invisio ICN Flexible CystoNephroscope .............

15

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99-1089 REV 10

Repair/Return/
Warranty

Repair/Return

All returns for credit must have prior written authorization. All medical devices returned to ACMI for any

reason must be 1) disassembled, 2) cleaned, and 3) high-level disinfected or sterilized in accordance with the
product’s instructions for use or labeling, and shipped in accordance with ACMI’s return procedures (available
upon request) and all applicable regulations. Prior to making any return, call ACMI Customer Service at (888)
524-7266.

Return to (worldwide):
ACMI Corporation – Stamford

Attn: Product Repair Dept.
300 Stillwater Avenue
Stamford, CT 06902-3695. USA
Ph: [phone] or [phone]
Fax: [phone]

Limited Express Warranty

SHOULD THE PRODUCT BECOME INOPERABLE, DURING NORMAL AND PROPER USE IN ACCORDANCE
WITH APPLICABLE INSTRUCTIONS, WITHIN THE TIME FRAME SPECIFIED BELOW FROM THE DATE OF SHIP­MENT, ACMI WILL REPAIR OR REPLACE THE PRODUCT, AT ITS SOLE OPTION, AT NO CHARGE. ACMI MAKES
NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCTS AND EXPRESSLY DISCLAIMS ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE
OR ANY OTHER MATTER. IN NO EVENT SHALL ACMI BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES.

This Warranty runs only to the original user and may be voided if the product(s) are serviced or repaired by
anyone other than ACMI or an organization duly authorized by ACMI for such purpose.

Invisio ICN Flexible CystoNephroscope (excluding cable).................................................................. 2 years

Invisio ICN Flexible CystoNephroscope cable only ............................................................................... 1 year

Accessories ........................................................................................................................................... 90 days

SP-1102

WA-1201

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Warnings and
Cautions

The following warnings and cautions apply to the use, care, and/or maintenance of the ACMI® Invisio ICN
Flexible CystoNephroscope System. Failure to comply with, or abide by, any warning or caution set forth in
this manual will void the video system’s Limited Express Warranty.

Warnings

(indicate that a danger to life or health can result from misusing the equipment)

1. SERVICE WARNING AND DISCLAIMER NOTICE: It is recommended that the medical equipment for
which these documents apply be returned to ACMI for servicing or repair. Service or repair
provided by any party other than ACMI or an ACMI-authorized repair facility may result in the user
and/or repair facility being liable and responsible for damages, including patient or user injuries,
arising from such servicing or repair, and any such servicing or repair shall void the
manufacturer’s Limited Express Warranty, if any, applicable to such medical equipment.

2. To prevent electric shock and breakage of seals, do not remove covers on the Invisio ICN Flexible

CystoNephroscope or Invisio IDC Digital Controller as a potential electric shock hazard exists. Refer
all repairs to ACMI-authorized service personnel.

3. Study this manual and other labeling thoroughly for safe handling and storage. Misuse of the
equipment can cause injury to the patient and could have an adverse effect on the procedure being
performed. Do not drop equipment, or allow it to be struck by other objects.

4. Procedures should be performed only by persons with adequate training and preparation. Consult the
medical literature regarding techniques, complications, and hazards prior to any procedure.

5. Do not use electromedical energy sources in the presence of flammable detergents, anesthetics,
nitrous oxide (N2O), or oxygen.

6. Consult the operating manuals of all electromedical energy sources used with endoscopic instruments
for appropriate instructions, warnings, and cautions prior to use. Such sources of energy include
electrical, electrohydraulic, electrosurgical, heat, hydraulic, laser, light, pressure, sound, ultrasound,
and vacuum.

7. Make no repairs to any Invisio ICN Flexible CystoNephroscope or Invisio IDC Digital Controller

Personal injury or damage to units may result. Refer units to ACMI-authorized service personnel for
repair.

8. Never look directly into the light emitted from the Invisio ICN Flexible CystoNephroscope. Damage to
the eyes can result.

9. Keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all
times when active.

10. Use only those lubricants specified in the labeling.

11. Prior to use, examine each electrode and its insulation for damage; do not use if damaged.

12. Follow the disinfectant or sterilizer manufacturer’s recommended procedures and cautions.

13. Do not use disinfectant solutions that contain long-life surfactants; such solutions can leave

conductive residues.

14. Do not use an instrument that fails to meet the criteria stated in the labeling or that has been

damaged.

15. When instruments from different manufacturers are used together, verify that any isolation or

grounding is not violated.

16. Follow the labeling instructions regarding the disposal or reuse of accessories. Reuse of disposable

accessories could compromise patient safety.

.

® Registered trademark of ACMI Corporation or its Subsidiaries in the U.S. and /or other countries of the world

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99-1089 REV 10

Warnings and Cautions
(continued)

Cautions

(indicate that equipment or other property may be damaged or may malfunction by misuse)

1. Pay close attention to the care, cleaning, disinfection, and sterilization instructions in this manual. Any
deviation can cause damage and void ACMI’s Limited Express Warranty. Do not steam sterilize the

Invisio ICN Flexible CystoNephroscope or Invisio IDC Digital Controller.

2. To ensure continued satisfactory performance, perform the prescribed inspections and operational

tests as recommended.

3. Thoroughly check all electrical cables and plugs before each use and replace any which are damaged
or excessively worn. Do not use if damage is suspected or discovered.

4. Check the outer surface of the flexible shaft prior to each use to make certain that the instrument is
free of any cuts, holes, rough surfaces, sharp edges, or protrusions. Do not use if damage is
suspected or discovered.

5. Do not insert a wet connector into the Invisio IDC Digital Controller receptacle, as poor video
performance and/or damage to the system may result.

6. These instruments contain no user-serviceable parts. Refer all repairs to ACMI-authorized service
personnel.

7. Connect electromedical energy source power cables only to properly wired grounding receptacles.

8. The Invisio ICN Flexible CystoNephroscope is listed by CSA as meeting Medical and Dental Equipment

Standard UL 2601 and CSA Standard 22.2 No. 601 and IEC-601.

9. Prior to use of a cardiac defibrillator, remove endoscopic instruments from the patient. Failure to
remove an endoscopic instrument from a patient during use of a cardiac defibrillator could result in
damage to the instrument due to the discharge of the cardiac defibrillator.

10. Testing to ensure that chassis leakage does not exceed the allowable levels per the appropriate

standard should be performed at least once each year. ACMI will make available on request circuit
diagrams, component part lists, descriptions, calibration instructions, or other information which will
assist the user’s appropriately qualified technical personnel to repair those parts of equipment which
are designated by ACMI as repairable.

11. Do not adjust electronic circuitry. Electronic circuitry is set at the factory and no further adjustment

is necessary.

12. Never remove the Invisio ICN Flexible CystoNephroscope from the Invisio IDC Digital Controller by

pulling on the cable. Always pull the insertion (connector) body to remove the cable from the IDC
Digital Controller.

13. U.S. Federal law restricts this device to sale by or on the order of a physician.

99-1089 REV 10

Section 1.0
Unpacking and Initial Inspection

Upon receipt, examine the shipping carton and its contents for signs of damage. Check for rattling or loose
material inside. Examine the Invisio ICN Flexible CystoNephroscope, Invisio IDC Digital Controller, and
accessories for damage. Do not use a damaged product—contact ACMI Customer Service at (888) 524­7266 or [phone].

It is very important that upon unpacking the equipment the proper video format selection is made: PAL,
VGA (Progressive Scan), or NTSC. See Invisio IDC Digital Controller Operations and Technical Manual
80819 for more detailed instructions.

Section 2.0
General Description and Intended Use

The Invisio ICN Flexible CystoNephroscope System consists of a Digital Flexible CystoNephroscope with an
integrated cable, accessories, an Invisio IDC Digital Controller, and all required video connection cables.

The ACMI Invisio ICN Flexible CystoNephroscope System (which includes the Invisio ICN Flexible
CystoNephroscope and Invisio IDC Digital Controller) is intended for use to examine body cavities, hollow
organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior
of the kidney; and using additional accessories, can be used to perform various diagnostic and therapeutic
procedures.

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