Quest Engineering ART-LAP-0008 User manual

Laparoscope
Instructions for Use

Laparoscope
Instructions for Use

Corporate Headquarters
Quest Medical Imaging B.V.
Industrieweg 41
1775 PW Middenmeer
The Netherlands
Website: www.quest-mi.com
Customer Service and Technical Support
Email: [e-mail]
Phone: [phone]
Fax: [phone]
Contact USA
Quest Medical Imaging
Everett Building, Suite 501
39 East Market Street,
Akron, Ohio 44311 U.S.A.
Customer Service and Technical Support
Email: [e-mail]
Phone: [phone]
Fax: [phone]
Document Identification
Document: QMI0024_IFU_EN_07052021_v1_1
Revision: 1.1
Copyright statement:  2021 Quest Medical Imaging B.V.
All rights reserved. No part of this document may be photocopied, reproduced or
translated in any way, without the prior written consent of Quest Medical Imaging B.V.
Every effort has been made to make the supplied product and its documentation as
accurate as possible.
The information contained in this document is subject to change without notice.
Printed in The Netherlands.

Quest Spectrum® Laparoscopes
1
Table of Contents
1 Health and Safety Compliance ..................................................................................................... 2
1.1 Important Information .............................................................................................................. 2
1.2 Indication for Use ..................................................................................................................... 2
1.3 Foreseeable misuse ................................................................................................................ 2
1.3.1 Contraindications: ............................................................................................................ 2
1.4 User Qualifications................................................................................................................... 3
1.5 Repair and Modification ........................................................................................................... 3
1.6 Labels on Packaging ............................................................................................................... 3
2 Safe application and preparation ................................................................................................. 4
2.1 Packaging and storage ............................................................................................................ 4
2.2 Prior Use .................................................................................................................................. 4
2.3 Intraoperative Use ................................................................................................................... 4
3 Assembly and Disassembly ......................................................................................................... 5
3.1 Combinations ........................................................................................................................... 6
4 Cleaning/Disinfection .................................................................................................................... 6
4.1 Safe treatment ......................................................................................................................... 6
4.2 After every use ......................................................................................................................... 6
4.3 Manual cleaning/disinfection ................................................................................................... 7
4.4 Machine cleaning/disinfection .................................................................................................. 7
4.5 Maintenance, checking ............................................................................................................ 8
4.6 Packing .................................................................................................................................... 8
5 Sterilization .................................................................................................................................... 8
5.1 General Remarks..................................................................................................................... 8
5.2 Sterilization method ................................................................................................................. 9
5.3 Storage .................................................................................................................................... 9
5.4 Information on validation ......................................................................................................... 9
6 Accessories/spare parts ............................................................................................................... 9
7 Standards/Directives ................................................................................................................... 10
8 Disposal ........................................................................................................................................ 10
8.1 General Remarks................................................................................................................... 10
8.1.1 Wet Disposal .................................................................................................................. 10
8.1.2 Dry Disposal .................................................................................................................. 10
9 Product Life cycle ........................................................................................................................ 10

Quest Spectrum® Laparoscopes
2
1 Health and Safety Compliance
1.1 Important Information
WARNING: Read Before Use
This instruction manual contains essential information on using the Quest
Spectrum® Laparoscopes safely and effectively. Before use, thoroughly review this manual and
use the system as instructed.
Keep this manual in a safe, accessible location. Questions or comments about any information
in this manual should be sent to Quest Medical Imaging B.V.
The following signal words serve to distinguish between warning notes according to the type of
danger:
WARNING: indicates risks to the safety of the patient or user. Failure to
follow warnings may result in injury to the patient or user.
CAUTION: indicates risks to the equipment. Failure to follow cautions may
result in product damage.
Note: provides special information to clarify instructions or
present additional useful information.
1.2 Indication for Use
During the examination, diagnosis and/or (in combination with endoscopic accessories)
treatment, Laparoscopes serve exclusively to visualize the abdominal cavity.
WARNING: The Quest Spectrum® Laparoscope should be used according to
its approved Indication for Use.
1.3 Foreseeable misuse
WARNING: Do not use Laparoscopes for other endoscopic applications.
WARNING: Connect Laparoscopes exclusively to BF devices (body floated
devices).
1.3.1 Contraindications:
 General inoperability
 Ambiguous diagnosis
 Lack of willingness on the part of the patient
 Technical preconditions not met

Quest Spectrum® Laparoscopes
3
1.4 User Qualifications
This manual is addressed exclusively to qualified personnel (licensed physician, medical
assistants supervised by a licensed physician). The Quest Spectrum® Laparoscope is to be used
exclusively by qualified personnel to carry out clinical applications.
WARNING: This manual does not explain or discuss clinical procedures. The
qualified personnel is responsible for correct execution of clinical
procedures.
1.5 Repair and Modification
WARNING: Do not disassemble, modify or attempt to repair the Quest
Spectrum® Laparoscopes. Patient or user injury and/or
instrument damage can result
 Let exclusively the respective dealer or a repair facility
authorized by Quest Medical Imaging carry out repair works.
 Use exclusively original spare parts for repair works.
Before sending it back:
 Clean, disinfect and sterilize the light guide cable and
laparoscope thoroughly prior to returning for repair.
Note: The guarantee and warranty claims expire if repair works are not
carried out by repair facilities authorized by Quest Medical
Imaging
1.6 Labels on Packaging
Table 1: Labels on Packaging
Observe Operating Instructions
Date of Manufacture
Manufacturer
Change designation
Serial number
Article number
Working Length
WL
Non-sterile
Keep away from sunlight
Keep dry

Quest Spectrum® Laparoscopes
4
2 Safe application and preparation
2.1 Packaging and storage
WARNING: The laparoscope is not sterilely packed.
 Prior to the first sterilization, clean the laparoscope
thoroughly (manually or using a machine according to
chapter 4).
 After every use, clean, disinfect and sterilize the laparoscope
(see chapter 4 Cleaning/ Disinfection).
 Keep the new or unused laparoscope in a dry, clean and safe
place at room temperature.
 Store and pack laparoscopes individually in a dry place at
room temperature.
CAUTION: Do not bend the laparoscope.
Note: To prevent damages on the working end: Insert the laparoscope
carefully through a trocar.
2.2 Prior Use
Note: After every cleaning/disinfection and prior to every use, check the
laparoscope for: cleanness, function and damages, e.g.
insulation, loose, bent, broken, chapped, rough, worn, broken off
parts etc.
WARNING: Do not use a damaged or defective laparoscope. Contact Quest
Medical Imaging.
2.3 Intraoperative Use
WARNING: It is possible that light with a high radiation energy emerges from
the viewing window and raises the temperature of the tissue.
 Make sure that the surface temperature of the body does not
exceed 41 °C.
 During longer applications, let the body cool down if necessary.
 Only use light sources from Quest Medical Imaging.
WARNING: In case of suspected or diagnosed Creutzfeldt-Jacob syndrome,
Quest Medical Imaging recommends not to reuse the
laparoscope but to dispose of it.
Immediately take measures to prevent the infection of other
patients, users or third parties.
Observe country-specific laws and specifications.

Quest Spectrum® Laparoscopes
5
CAUTION: To maintain the optical quality, make sure that the laparoscopes
are not exposed to gamma rays.
Note: Check image quality (clear and free of distortion) and light
transmission through the glass fibers.
 Hold the light guide connector against non-glare light. Should
the glass fibers appear as black spots on the distal end (broken
glass fibers), it is possible that the light output is insufficient.
3 Assembly and Disassembly
Figure 1 shows the construction of the Quest Spectrum® Laparoscope. The Eyepiece can be
only connected to the Quest Spectrum® Camera. Table 2 provides an overview of all
laparoscopes provided by Quest Medical Imaging and Table 3 provides an overview of all
accessories.
Figure 1: Construction of the Laparoscope
(1) Objective with sapphire window
(2) Duct
(3) Body
(4) Eyepiece
(5) Color code ring (line of vision)
(6) Adapter for light guides, removable
(7) Adapter for light conductors,
removable.
(8) Connecting piece for light guides
(ACMI)
Note: Only the light guide connector can be dissembled from the
Laparoscope.
Table 2: overview of all laparoscopes provided by Quest Medical Imaging.
Article Number Line of vision Color Code Field of View Working Length
ART-LAP-0008 30° Red 70° 290 mm
ART-LAP-0008S 30° Red 70° 150 mm
ART-LAP-0009 0° Green 70° 290 mm
ART-LAP-0009S 0° Green 70° 150 mm
Table 3: accessories of the Laparoscope
Article Number Name Use
ART-OP-0007 Optical fiber Light Guide from Light Engine to Laparoscope
For a safe assembly:
 Always hold the laparoscope on the body or the eyepiece.
 Make sure that the adapters of the light- conducting cables comply with the adapters of the
laparoscope (see Figure 1).
 Make sure that glass surfaces do not interact with other instruments.

Quest Spectrum® Laparoscopes
6
3.1 Combinations
WARNING: Danger to life due to high tensions and currents!
Make sure that the leakage currents of the patient are minimized for
combinations:
 Connect the Laparoscopes only to devices and accessories of
Quest Medical Imaging.
 Connect Laparoscopes exclusively to BF devices (body floated
devices).
Note: Contact Quest Medical Imaging if you want to connect devices
not provided by Quest Medical Imaging.
4 Cleaning/Disinfection
4.1 Safe treatment
Make sure that laparoscopes and accessories are cleaned and sterilized exclusively by trained
and qualified personnel.
 Clean and sterilize laparoscopes before first use. Remove protective transport sheaths.
 Exclusively treat laparoscopes and accessories suitable for:
o immersion in cleaning agent
o vapor sterilization
 Use exclusively cleaning agents for complete protein dissolution.
WARNING: Do not exceed maximum number of treatments (see manual of
respective product).
WARNING: Do not use laparoscopes or accessories once their product lives
are expired (see manual of respective product).
WARNING: Treat laparoscopes and accessories before the first and after
every use.
WARNING: Make sure that laparoscopes and accessories do not touch
during cleaning.
WARNING: Prevent any fixation of proteins before and during treatment.
CAUTION: Do not apply strong manual pressure.
CAUTION: Do not use abrasive cleaning agents or metal brushes.
CAUTION: Do not use plastic sheaths for treatment.
CAUTION: Do not clean laparoscopes in an ultrasonic bath.
CAUTION: Do not gamma-sterilize laparoscopes.
4.2 After every use
After every use treat contaminated laparoscopes and accessories as soon as possible.
1. Disassemble detachable laparoscopes and accessories.
2. Remove sealing caps.

Quest Spectrum® Laparoscopes
7
3. Soak encrusted laparoscopes and accessories in 3 % H2O2 for 5 minutes before cleaning
and disinfection.
4. Use fully desalinated water. Clean manually or in a machine. Observe manufacturer's
indications (e.g. dosing).
5. Always machine-clean after contact with:
 blood
 wounds
 interior tissue
 organs
CAUTION: In case of contact with a corrosive substance, clean with water
immediately.
4.3 Manual cleaning/disinfection
Note: Clean laparoscopes and accessories manually exclusively when
machine cleaning is not possible.
In order to clean the laparoscopes and accessories manually, perform the following steps:
1. Observe indications of cleaning agent manufacturer.
2. Use a cleaning agent with a medium pH value (5 - 11).
3. If immediate cleaning is not possible: Soak laparoscopes and accessories in enzymatic
cleaning agent for 15 minutes in such a way that all surfaces, cavities, lumens, and openings
are covered. Observe indications of disinfectant manufacturer.
4. Do not exceed maximum soaking time of 15 minutes.
5. Clean windows (distal and proximal) and glass fiber ends with a cotton swab (wood) or soft
cloth soaked in isopropyl alcohol (70%) or acetone. Alternatively, use a neutral detergent
(hand soap).
6. After chemical disinfection, always rinse sufficiently and thoroughly under clear running
water. Observe indications of disinfectant manufacturer.
7. Remove stubborn dirt with a soft plastic brush. Do not use abrasive cleaning agents or metal
brushes.
8. Clean lumens and channels using soft round plastic brushes, and rinse thoroughly.
9. Use fully desalinated water for final rinsing.
10. Dry laparoscopes with an absorbent, soft, and lint-free cloth.
11. Dry laparoscopes at 60 °C for at least 2 hours.
12. Use compressed air to dry lumens and channels.
13. After cleaning. Lubricate cocks using an approved lubricant.
Note: Diameters of lumens and brushes must be the same.
4.4 Machine cleaning/disinfection
Note: Quest Medical Imaging recommends machine cleaning for
laparoscopes and accessories.
In order to clean the laparoscopes and accessories with a machine, perform the following steps:
1. Carry out thermal disinfection in a machine. Observe national requirements regarding A0
value (see ISO 15883).
2. Clean laparoscopes and accessories exclusively in instrument washers, and with suitable
methods.
3. Observe indications of ultrasound cleaner, washers and cleaning agent manufacturers.
4. Make sure that manufactures of ultrasound cleaners, washers, and cleaning agents
recommend their methods for laparoscopes and accessories.
5. For machine cleaning, put laparoscopes and accessories on suitable screen baskets
suitable for cleaning (avoid "cleaning shadows").

Quest Spectrum® Laparoscopes
8
6. Make sure that laparoscopes and accessories are properly secured in the holders.
7. Connect rinsing or working channels of laparoscopes and accessories to rinsing connectors
of washer.
8. Use a cleaning agent with a medium pH value (5 - 11).
9. Soak laparoscopes and accessories in enzymatic cleaning agent for 15 minutes at most.
10. Use thermically neutral methods in the pH-neutral range (e.g. enzymatic cleaning agents).
11. Select cleaning cycle depending on material (e.g. stainless instrument steel, aluminum) of
laparoscopes and accessories to be cleaned. Observe indications of device manufacturer.
12. Pre-rinse laparoscopes twice.
13. Clean laparoscopes at 40 °C - 60 °C.
14. Disinfect at 80 °C - 95 °C.
15. Dry at 50 °C.
16. Observe sufficient drying time.
17. Make sure that there is no residue on the glass fiber surface. This can possible impair light
transmission through burning in when exposed to a light source.
18. Take laparoscopes and accessories out of washer immediately when cleaning cycle is
finished.
19. Allow laparoscopes and accessories to cool down to room temperature (23 ± 2 °C).
4.5 Maintenance, checking
 Allow laparoscopes and accessories to cool down to room temperature.
 After every cleaning and disinfection, check laparoscopes and accessories for protein residue
and dirt. Clean contaminated or dirty laparoscopes and accessories again.
 Lightly grease movable parts (e.g. hinges and ends) with serializable, vapor-permeable
protective oil.
 Use exclusively bio-compatible, paraffin oil based lubricants (exception: latex and rubber).
 Assemble detachable laparoscopes and accessories.
 After every cleaning/disinfection, check laparoscopes and accessories for: cleanliness,
proper functioning, and damage, e.g. loose, bent broken, cracked, worn, missing parts etc.
 Reject and replace damaged, defective, stained, or cloudy laparoscopes and accessories.
 Laparoscopes and accessories are maintenance-free.
4.6 Packing
 Always store and package laparoscopes individually.
 Store laparoscopes in original packaging, or in a suitably sized sterilization container.
 Store laparoscopes with small diameters (3.0 mm and less) in the protective transport and
storage sheaths available at Quest Medical Imaging.
5 Sterilization
5.1 General Remarks
Note: It is possible for sterilization methods not listed in this manual to
be compatible with Quest Medical Imaging laparoscopes and
accessories.
When using methods other than those listed in this manual, the
user is responsible for the sterility.
 Use exclusively suitable methods for sterilizing laparoscopes
and accessories (see chapter 5.2 Sterilization method).
 Make sure that a sufficient number of sterile laparoscopes
and accessories is available.
Observe the following when sterilizing:

Quest Spectrum® Laparoscopes
9
1. Clean laparoscopes thoroughly before sterilizing (see chapter 4 Cleaning/disinfection).
2. Make sure that the entire surface is exposed to the sterilization medium.
3. Avoid any contact with metal surfaces.
4. Make sure that laparoscopes are properly secured in the holders.
5. Do not sterilize laparoscopes still in their protective transport sheaths.
6. Sterilize laparoscopes individually and suitably packaged.
5.2 Sterilization method
 Sterilize laparoscopes and accessories according to generally accepted hospital method.
 Observe manufacturer's indications for auxiliaries.
 Make sure that products are packaged according to ISO 11607 and EN 868 for sterilization.
 Carry out sterilization according to EN 13060/EN ISO 17665-1.
 Observe applicable country-specific requirements.
Table 4 Validated Sterilization method.
Parameters 134 °C / 273°F
Double fore
-
vacuum
132 °C / 270°F
Double fore
-
vacuum
Sterilization time
3
–
20 min
4
–
20 min
Packaging
Metal sterilization containers,
paper laminate sterilization bags,
Type Steriking
Metal sterilization containers,
paper laminate sterilization bags,
Type Steriking
Note: Exclusively vapor-sterilize laparoscopes marked autoclavable.
CAUTION: Do not accelerate cooling of laparoscopes and accessories. This
will cause damage and reduce the product life.
 Allow laparoscopes and accessories to cool down to room
temperature (23 ± 2 °C).
 Open packages after cooling.
5.3 Storage
After sterilizing, store laparoscopes in a dry, dust-free, and well-aired place (free of corrosive
vapors).
5.4 Information on validation
As prescribed by § 4 MPBetreibV, the treatment using a suitable validated method is approved
by a laboratory accredited by the ZLG (Central Authority of the Länder for Health Protection with
regard to Medicinal Products and Medical Devices in accordance with the directives 93/42/ EWG,
90/385/EWG, and DIN EN ISO/IEC.
The following materials and machines were used for the validation:
 Disinfectant: Korsolex®
 Cleaning agent: Neodisher Mediclean by Dr. Weigert
 Neutralizing agent: Neodisher Z by Dr. Weigert
 Cleaner: Miele G7735
 Sterilizing agent: humid heat
6 Accessories/spare parts
Our catalogs contain information about accessories and spare parts.

Quest Spectrum® Laparoscopes
10
7 Standards/Directives
All laparoscopes are manufactured in accordance with the following directives:
o Medical device directive 93/42 EWG last changed by 2007/47/EG
o EN ISO 13485
o Series of standards IEC 60601
o Series of standards ISO 8600
o FDA regulations (FDA Quality System Regulation 21 CFR Part 820) other product and
material-specific standards and regulations
8 Disposal
8.1 General Remarks
For the disposal, mind the following:
 Dispose of the packaging and used parts in accordance with the country-specific regulations.
 Protect the device from access by unauthorized persons.
8.1.1 Wet Disposal
 Use cleaning-active disinfectants.
 Completely immerse endoscopes and accessories in a non-corrosive, non-fixing disinfection bath
that is changed daily.
 Leave endoscopes and accessories in disinfection bath for a maximum of 8 hours.
 Before machine cleaning and disinfection, rinse endoscopes and accessories thoroughly under
clear running water.
8.1.2 Dry Disposal
 Machine-clean endoscopes and accessories.
For the disposal, mind the following:
 Dispose of the packaging and used parts in accordance with the country-specific regulations.
 Protect the device from access by unauthorized persons.
9 Product Life cycle
Life cycle of medical device: 2 years or 400 cycles
After end of life cycle:
 Check Laparoscopes for: cleanliness, proper functioning, and damage, e.g. insulation, loose,
bent, broken, cracked, worn, missing parts etc.
 If necessary, have Laparoscopes treated by Quest Medical Imaging.
 If necessary, dispose of Laparoscopes correctly (see chapter 8)

Quest Spectrum® Laparoscopes
11
Declarations of Conformity
Manufacturer
:
Quest Medical Imaging B.V.
Industrieweg 41
1775 PW Middenmeer
the Netherlands
We declare under our sole responsibility that the Quest Spectrum® Laparoscope complies
with the following directive:
Directive 93/42/EEC-M5 for medical devices
The individual components of your Quest Spectrum® Laparoscope bear the CE mark. Quest
Medical Imaging B.V. herewith declares that:
(a) We have verified the mutual compatibility of the devices of the Quest Spectrum®
Laparoscope in accordance with the manufacturers' instructions and have carried out his
operations in accordance with these instructions;
(b) We have packaged the Quest Spectrum® Laparoscope and supplied relevant
information to users incorporating relevant instructions from the manufacturers; and
(c) We have subjected the whole activity to appropriate methods of internal control
and inspection.
2797