Stryker 1688 Series Manuale utente

1688 4K Camera System

1688010000

1688210105

1688310130

1688610122

1688710105

with Advanced Imaging Modality

Contents

Warnings and Cautions ........................................................................... 1

Cautions ......................................................................................................................1

Warnings: General ...................................................................................................1

Warnings: SPY Mode...............................................................................................3

Operating a Light Source......................................................................................4

Product Description and Intended Use ................................................. 5

Indications..................................................................................................................6

The Camera Console...............................................................................................7

The Camera Head ....................................................................................................9

Additional Features of the Pendulum Camera Head............................... 10

The C-Mount Coupler.......................................................................................... 12

Device Compatibility........................................................................................... 13

Setup ......................................................................................................15

Setting Up the Console ...................................................................................... 16

Wiring Diagram ..................................................................................................... 18

Setting Up the Camera Head............................................................................ 19

Setting Up the Coupler....................................................................................... 20

Installing the Soaking Cap ................................................................................ 22

SPY Mode Requirements ................................................................................... 23

Operation ...............................................................................................24

Powering the Console On/O.......................................................................... 24

Performing the White Balance Test ................................................................ 24

Controlling Remote Video Accessories......................................................... 25

Using the Touchscreen Interface..................................................................... 26

Using the Camera Head Buttons..................................................................... 30

Using the Display Monitor Menu.................................................................... 33

Programming Camera Head Buttons ............................................................ 36

Advanced Features............................................................................................... 37

Troubleshooting .................................................................................... 38

Reprocessing.......................................................................................... 42

Cleaning and Disinfecting the Console........................................................ 42

Cleaning, Disinfecting, and Sterilizing the Camera Head ...................... 43

Materials and Equipment .................................................................................. 45

Maintenance ..........................................................................................50

Inspecting the Console....................................................................................... 50

Inspecting the Camera Head............................................................................ 50

Using Sterile Drapes ............................................................................................ 51

Storage ..................................................................................................................... 51

Replacing the Fuses............................................................................................. 51

Periodic Maintenance Schedule...................................................................... 52

Service Life.............................................................................................................. 52

Disposal.................................................................................................................... 52

Recycling Diagrams ............................................................................................. 53

Technical Specications........................................................................ 55

Electromagnetic Compatibility........................................................................ 56

Symbol Denitions................................................................................60

Warnings and Cautions

In this manual, the terms and denitions below apply.

• Warning: Possible injury to the patient or user.

• Caution: Possible damage to the equipment.

• Note: More information to clarify the instructions.

Cautions

To avoid potential damage to this device, please note the following cautions.

1. Carefully unpack this device and check if any damage occurred during

shipment. If damage is detected, refer to the warranty.

2. Never sterilize the camera console, because the delicate electronics

cannot withstand this procedure.

3. Ensure that the electrical installation of the relevant operating room

complies with the NEC and CEC guidelines.

4. Always treat the camera system with care. The camera system contains

sensitive parts that are precisely aligned and may suer damage if

dropped or mistreated.

5. Repairs and equipment modications shall be performed only by Stryker-

authorized personnel. Stryker Endoscopy assumes no product liability or

warranty responsibility for devices repaired by or purchased from third-

party service organizations.

Warnings: General

To avoid potential serious injury to the user and the patient and/or damage to

this device, please note the following general warnings.

1. Federal (USA) law restricts this device to sale by or on the order of a

physician.

2. Read this operating manual thoroughly, especially the warnings, and be

familiar with its contents before connecting and using this device.

3. Although the product was fully tested at the factory before shipment,

the user should always test it for proper function prior to a surgical

procedure.

4. Always test that the endoscope produces a live, clear, correctly-oriented

image prior to using it in a procedure and immediately after any viewing

mode or setting is changed in the camera system.

5. The camera head surface may exceed 41°C (106°F) in operating

conditions with high ambient temperatures and it should be handled

with caution.

6. The camera head and coupler are shipped non-sterile. You must sterilize

these devices before the rst use and after each use. To prevent device

damage and infection risk to the patient or user, follow all cleaning and

sterilization instructions in this manual.

7. To minimize electromagnetic interference that may impact functionality

of the 1688 Video Camera, position any active electrosurgical generator

and its cables at least 12 inches (30 cm) away from the camera console.

When the electrosurgical generator is placed on a boom with the camera

console, it is advised to position the generator on the lowest shelf.

8. Do not position the console so that it is dicult to disconnect the power

cord from the supply mains.

9. To avoid the risk of electric shock, this equipment must only be

connected to a supply mains with protective earth ground.

10. Portable multiple socket-outlets shall not be placed on the oor.

Additional portable multiple socket-outlets or extension cords shall not

be used with the equipment.

11. Use of third-party HDMI cables with the camera console is not

recommended due to potential problems with secure connections or

electromagnetic compatibility. Use the provided HDMI high speed cable

(or other Stryker-approved HDMI cable) with the camera console.

12. Never use the camera system in the presence of ammable or explosive

gases or in an oxygen-rich environment.

13. To prevent tampering, physically secure the device when not in use.

14. Disconnect the console from the electrical outlet when inspecting fuses.

15. Do not remove covers on the console, as doing so may cause damage to

electronics and/or electric shock.

16. Do not disassemble any part of the camera head; doing so may break the

seals, causing leakage and/or electric shock.

17. Attempt no internal repairs or adjustments not specically detailed in this

operating manual.

18. Do not repair or adjust the device through a third-party service

organization. Devices repaired by or purchased from third-party service

organizations could expose patients to signicant risk. These devices

are no longer validated by Stryker for cleanliness, disinfection, and

sterilization, or for safety and ecacy.

Warnings: SPY Mode

IMPORTANT SAFETY NOTICE - LASER RADIATION:

SPY mode controls a Class1M laser emitted from the L11 LED

Light Source with Advanced Imaging Modality (0220230300), also

referred to as the “L11 LED Light Source.”

Use of controls or performance of procedures other than those

specied herein can result in hazardous laser radiation exposure

and can cause severe eye injury to the patient or user.

To avoid exposure to laser radiation, follow all warnings and

guidelines presented below and throughout this user manual.

1. Before using SPY mode, read and be familiar with all instructions and

warnings found in this user manual and the light source user manual.

2. Protect the camera system against unqualied use.

3. Wear eye protection as appropriate. Refer to any applicable regional

regulations or standards for personal protective equipment.

4. Do not manipulate tissue while Contrast mode (a SPY mode) is on.

5. When using SPY mode, do not view the light output with optical

instruments (for example, microscopes or magniers). Do not direct the

light output in SPY mode into an area where such instruments are likely

to be used.

6. Do not turn on SPY mode when the endoscope is outside of the patient’s

body.

7. When SPY mode is on, never look into the following apertures or direct

the light emitted from the apertures toward another person:

• the light cable connection on the light source (if the cable is not

attached)

• the end of the light cable (if the SafeLight™ adapter is attached)

• the endoscope tip

8. When SPY mode is on, never leave a SafeLight adapter attached to the

light cable without an endoscope attached. Laser radiation can continue

to emit from the adapter.

9. Disconnect the light cable from the light source only when the light

source is powered o or the light output is deactivated.

Operating a Light Source

Please note the following warnings to avoid user or patient injury or product

damage when using a system with a light source. Note that the light source

adjustments described apply only to operating the light source manually (i.e.,

with Auto Light o).

IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES:

When using a light source, re and/or severe injury may result to

the patient, user or inanimate objects if the instructions in this

manual are not followed.

All light sources can generate signicant amounts of heat

(exceeding 41°C/106°F) at the scope tip, the scope light post, the

light cable tip, and/or near the light cable adapter. Higher levels

of brightness from the light source result in higher levels of heat.

Always adjust the brightness level of the camera and the display

monitor before adjusting the brightness level of the light source.

If the brightness level of the light source can be adjusted, set it to

the minimum brightness necessary to adequately illuminate the

surgical site.

In addition, adjust the internal shutter of the camera higher in order

to run the light source at a lower intensity. Avoid touching the

scope tip or the light cable tip to the patient, and never place them

on top of the patient, as doing so may result in burns to the patient

or user. In addition, never place the scope tip, the scope light post,

the light cable adapter, or the light cable tip on the surgical drapes

or other ammable material, as doing so may result in re.

Always deactivate the light output from the light source before

removing the scope from the light cable or leaving the device

unattended. The scope tip, scope light post, light cable adapter, and

light cable tip will take several minutes to cool o after deactivating

the light output, and therefore may still result in re or burns to the

patient, user, or inanimate objects.

The warranty is void if any of the above warnings or cautions are disregarded.

Product Description and Intended Use

The 1688 4K Camera System with Advanced Imaging Modality (or “1688Video

Camera”) is an endoscopic camera system that is used to produce live video

in the surgical eld during surgical endoscopic procedures. The system is

sensitive in the visible and infrared spectrum. The optical image is transferred

from the surgical site to the camera head by a variety of rigid and exible

scopes, which are attached to the camera head. The system consists of a

camera console and a camera head with an integral cable that connects to the

console. A coupler is also available for attaching a scope to the camera head.

The available models for each part are listed below.

Console

1688010000 16884K Camera Control Unit with Advanced Imaging

Modality

Camera Heads

1688210080 16884K Microscope Camera Head, C-Mount1, 2

1688210105 16884K Camera Head, C-Mount, with Advanced Imaging

Modality

1688310130 16884K Pendulum Camera Head with Integrated Coupler3

1688610122 16884K Camera Head, Integrated Coupler, with Advanced

Imaging Modality

1688710105 16884K Inline Camera Head, C-Mount, with Advanced

Imaging Modality

Coupler

1688-020-122 4K Coupler, C-Mount, with Advanced Imaging Modality4

1Complete instructions are available in Stryker user manual P45082. Note that 1688210080 does not have the same intended use

or indications as stated in this user manual.

2Not intended for use with SPY/ENV modes.

3Not compatible with SPY/ENV modes.

4Complete instructions are available in Stryker user manual P40880.

Note: For complete system requirements to use the camera’s SPY mode,

see the user manual for the L11 LED Light Source with Advanced Imaging

Modality (0220230300), also referred to as the“L11 LED Light Source.”

The camera console is also packaged with the following connection cables:

• Remote cables, 2.5 mm to 3.5 mm (Qty: 2)

• HDMI high speed cable (Qty: 1)

• Hospital-grade power cord (Qty: 1)

Contact your Stryker representative for availability of other cables that may be

required for alternate congurations.

Indications

The 1688 Video Camera is indicated for use in general laparoscopy,

nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever

a laparoscope/endoscope/arthroscope/sinuscope is indicated for use.

A few examples of the more common endoscopic surgeries are listed below.

• laparoscopic cholecystectomy

• laparoscopic hernia repair

• laparoscopic appendectomy

• laparoscopic pelvic lymph node detection

• laparoscopically assisted hysterectomy

• laparoscopic and thorascopic anterior spinal fusion

• anterior cruciate ligament reconstruction

• knee arthroscopy

• small joint arthroscopy

• decompression xation

• wedge resection

• lung biopsy

• pleural biopsy

• dorsal sympathectomy

• pleurodesis

• internal mammary artery dissection for coronary artery bypass

• coronary artery bypass grafting where endoscopic visualization is

indicated

• examination of the evacuated cardiac chamber during performance of

valve replacement

The users of the 1688 Video Camera are general surgeons, gynecologists,

cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons,

ENT surgeons and urologists.

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