Stryker
Urology Hardware User Guide
246 Pages
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Urology Hardware User Guide 0502–880–001,0502–880–002, 0502–880–003,0502–880–005, 0502–880–006, 0502–880–007 0502-880-2xx 0502–880–301, 0502–880–302, 0502–880–303, 0502–880–324, 0502–880–325, 0502–880–327, 0502–880–328 0502–880–401, 0502–880–402, 0502–880–425, 0502–880–426, 0502–880–427, 0502–880–428, 0502–880–429 0502–880–501, 0502–880–502, 0502–880–503, 0502–880–504, 0502–880–505, 0502–880–521, 0502–880–522, 0502–880–523, 0502–880–524, 0502–880–525 0502–880–605, 0502–880–650 0502-881-217, 0502-881-219, 0502-881-221, 0502-881-223, 0502-881-225 0502-990-322, 0502-990-324, 0502-990-401, 0502-990-414 0505-880-xxx
Contents
E n g l i s h... . ... . ... . ... . ... . ... . ... . ... . . 3 F r a n ç a i s . .. . ... . ... . ... . ... . ... . ... . ... 1 9 D e u t s c h .. .. . ... . ... . ... . ... . ... . ... . ... 3 5 I t a l i a n o... . ... . ... . ... . ... . ... . ... . ... 5 1 P o r t u g u ê s . ... . ... . ... . ... . ... . ... . ... 6 7 E s p a ñ o l . . .. . ... . ... . ... . ... . ... . ... . ... 8 3 N e d e r l a n d s... . ... . ... . ... . ... . ... . ... 9 9 D a n s k . ... . ... . ... . ... . ... . ... . ... . .. . . 1 1 5 S u o m i . ... . ... . ... . ... . ... . ... . ... . .. . . 1 2 9 N o r s k . ... . ... . ... . ... . ... . ... . ... . .. . . 1 4 3 S v e n s k a . .. . ... . ... . ... . ... . ... . ... . .. . . 1 5 7 P o l s k i . ... . ... . ... . ... . ... . ... . ... . .. . . 1 7 1 Ε λ λ η ν ι κ ά .. . ... . ... . ... . ... . ... . ... . .. . . 1 8 7 简 体 中 文 . .. . ... . ... . ... . ... . ... . ... . .. . . 2 0 3 日 本 語 ... . ... . ... . ... . ... . ... . ... . .. . . 2 1 5 한 국 어 ... . ... . ... . ... . ... . ... . ... . .. . . 2 2 9
1 ������ ����������� The hardware consists of various components that assemble into and/or work with one of two categories: diagnostic hardware and surgical hardware.
2 ����������� ��� ��� Stryker urology hardware is intended for use in urology/gynecology diagnostic and therapeutic surgical procedures to provide visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate.
3 ����������������� •
acute pelvic inflammatory disorder
Hysteroscopy may be contraindicated by the following conditions, depending on their severity or context: •
inability to distend the uterus cervical stenosis cervical/vaginal infection uterine bleeding or menses known pregnancy invasive carcinoma of the cervix recent uterine perforation medical contraindication or intolerance to anesthesia
Contrain dications to En dometrial Ab lation Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should not be undertaken without adequate training, preceptorship, and clinical experience. Additionally, endometrial biopsy should be performed prior to any ablation. The following are clinical conditions that can significantly complicate hysteroscopic endometrial ablation: •
Adenomatous Endometrial Hyperplasia Uterine Leiomyoma Severe Adenomyosis Pelvic Pain (Subtle PID) Uterine anomalies
Contraindications to Hysteroscopic Myomectomy EN- 5
Hysteroscopic myomectomy should not be undertaken without adequate training, preceptorship, and clinical experience. The following are clinical conditions that can significantly complicate hysteroscopic myomectomy: •
Severe anemia Inability to circumnavigate a myoma due to myoma size. (e.g., predominantly intramural myomas with small submucous components).
4 �������� •
For use only by physicians trained in hysteroscopy. Suspicion of pregnancy should suggest a pregnancy test before the performance of diagnostic hysteroscopy.
1. 2.
Read these instructions thoroughly before using this hardware. Inspect the hardware for any damage that may have occurred during shipment.
3.
Test the hardware for functionality before using it in a surgical procedure.
4.
This hardware is shipped non-sterile. Clean and sterilize the hardware prior to the first use and after every subsequent use. Follow the cleaning, disinfection, and sterilization instructions provided in this insert.
5.
Read and understand monopolar-electrode and highfrequency device manuals before use. Follow all warnings and cautions during the operation of such devices.
6.
Read and understand laser-delivery systems manuals before use. Follow all warnings and cautions during the operation of such devices. Federal law (USA) restricts this device to use by or on order of a physician.
7. 8.
Before every surgical procedure, inspect the resectoscope, especially the ceramic tip and guiding element, for damage or cracks. Do not use the device if it shows protrusions or rough or sharp edges.
9.
Do not reuse single-use monopolar electrodes with the resectoscope. Physician and patient safety will be compromised.
10. To maintain electrical isolation, use only Stryker electrodes and resectoscope cables. 11. When urology hardware is used with other applied parts, total patient current leakage may be additive. Ensure BF conditions are observed when using the resectoscope with electromedical devices. 12. For Continuous Flow Hysteroscopy: If a liquid distention medium is used, strict fluid intake and output surveillance should be maintained. Intrauterine instillation exceeding 1 liter should be followed with great care to the possibility of fluid overload. P o t e n t i a l C o m p l i c a t i o n s of Continuous Flow Hysteroscopy: •
Hyponatremia Hypothermia Uterine perforation resulting in possible injury to bowel, bladder, major blood vessels, and ureter
EN- 6
Pulmonary edema Cerebral edema 13.
The Ellik Evacuator contains natural rubber latex. When it is used with the system, take appropriate precautions to ensure patient safety.
14. Endoscopic procedures should be performed only by persons having adequate training and familiarity with endoscopic techniques. Consult medical literature relative to techniques, complications and hazards prior to performance of any endoscopic procedure. 15. Failure to use protective filters or suitable filtering spectacles during the activation of a surgical laser beam may cause eyedamage to the user. 16. Temperatures near, and in front of the high intensity light emitting tip may cause permanent tissue damage and /or coagulation if brought into patient contact. 17. Consult literature for the safe use of electrosurgical equipment. Inadvertent burns can occur when the appropriate patient return path is obstructed. 18. No modification of this equipment is allowed. 19. Keep active electrosurgical probes isolated from the patient when not in use. 20. Do not exceed the rated accessory voltage for the resectoscope working elements: Cut Upp = 3800 V Spray Coag = 4100 V
5 ����������� 1.
Urology hardware must be cleaned and sterilized prior to the first use and after every subsequent use.
2.
Vaginal ultrasonography before hysteroscopy may identify clinical conditions that will alter patient management.
3.
Intrauterine distension can usually be accomplished with pressures in the range of 37 – 75 mmHg. Unless the systemic blood pressure is excessive, it is seldom necessary to use pressures greater than 75 − 80 mmHg.
4.
The surface temperature near the light cable inlet may exceed 41°C if the unit is operated at maximum brightness for extended periods of time. Prior to disconnecting light guides or light guide connectors, turn off the illumination source and allow the endoscope to cool.
5.
Do not immerse or rinse instruments in cold water or any other liquid to accelerate cooling. Forced cooling may damage glass lenses and may render the endoscope unusable. Devices must be pre-cleaned to avoid debris being cooked or baked onto instrument surfaces.
6.
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6 ������� ����������� 6.1
Diagnostic Hardware
Diagnostic hardware consists of components that assemble into and/or work with a cysto sheath, which is used to perform urology/ gynecology diagnoses. The major hardware components and important features of the cysto sheath assembly are listed in Figure 1 below.
Figure 1. The cysto sheath assembly The cysto sheath assembly 1.
Cysto sheath
Color Coding for
2.
Inflow port
Cystosheaths
3.
Bridge
4.
Cysto scope
5.
Outflow port
6.
Eyepiece
7.
Light cable inlet
6.2
Yellow
17 Fr.
Green
19 Fr.
Red
21 Fr.
Blue
23 Fr.
White
25 Fr.
Surgical Hardware
Surgical hardware consists of components that assemble into and/ or work with a resectoscope, which is used to prepare for and perform endoscopic HF surgery. The major hardware components and important features of the resectoscope assembly are listed in Figure 2.
EN- 8
Fi gure 2.
Assembled resectoscope
1. 2. 3.
Outer sheath Inner sheath Working element
4. 5. 6.
RF cable connector Electrode isolation block Speed-lock mechanism
7.
Stopcock (2)
Surgical hardware also consists of components that assemble into and/or work with a Side Fire Laser Cystoscope System, which is used with the GreenLight PV ADDStat™ Disposable Fiberoptic Angled Delivery Device (GreenLight Laser). The major hardware components and important features of the Side Fire Laser Cystoscope System are listed in Figure 3.
Figure 3.
Assembled Side Fire L aser Cystoscope System
1.
Speed-lock mechanisms
2. 3. 4.
Inner sheath Outer sheath GreenLight Laser
5.
Rotating sweep guide
6. 7.
J-lock mechanism Working port
Warn ing:
Laser radiation is emitted from the tip of the
GreenLight Laser. When using the laser, avoid exposure to the eyes and skin. Wear appropriate eye protection as specified in the Laser user manual.
EN- 9
7 ���������� ��� �������� 7.1
Diagnostic Hardware
Assembling the Cysto Sheath and Obturator 1. Insert the obturator into the cysto sheath, aligning the “0” on the obturator (a) with the “0” on the cysto sheath (b) (see Figure 4).
Figure 4. Inserting the obturator into the cysto sheath 2.
Twist the obturator to lock it in place.
3.
Untwist the obturator to remove it from the cysto sheath.
Assembling the Cysto Sheath, Bridge, and Scope 1. Align the “0” on the bridge (a) with the “0” on the cysto sheath (b) and insert the bridge into the cysto sheath (see Figure 5).
Figure 5.
Inserti ng the bridge i nto the cysto sheath
2.
Twist the bridge to lock it into place.
3.
Slide the scope into the bridge speed-lock mechanism (a) until the two pieces snap together (see the Figure 6).
Fi gure 6.
Inserting the scope into the bridge speed-lock mechanism
4.
Press the speed-lock button on the bridge to remove the scope.
5.
Untwist the bridge to remove it from the cysto sheath.
EN- 10
Note: Th e cys to she ath ca n acc ommodate various instruments, such as obturators, visual obturators, bridges, and forceps. For a complete list of compatible instrumen ts, con tact a Stryker sale s represen tative.
7.2
Surgical Hardware
Assembling the Inner and Outer Sheaths with an Obturator 1. Slide the inner sheath (a) into the outer sheath (b) until the two pieces snap together (see the Figure 7).
Figure 7. Connecting the inner and outer sheaths 2.
Insert an obturator into the inner sheath (a) and rotate it until the guide pin locks in place (see Figure 8).
Figure 8.
Inse rti ng the obturator into the in ner shea th
Note: Th e inne r sheath can ac commod ate va rio us instrumen ts, such as obturators, b ladder-syri nge adapters, and the working element. For a complete list of compatible instruments, contact a Stryker sales re pre sentati ve. Assembling the Inner and Outer Sheaths with the Working Element, Scope, and Electrode 1. Connect a 4 mm cystoscope into the speed-lock mechanism (a) on the working element (see Figure 9). The scope should snap into place.
Figure 9.
2.
Connecting the 4 mm cystoscope to the speedlock mechanism
Slide a Stryker electrode into the electrode guide tube of the working element (a) until it snaps into the electrode isolation block (b) (see figure 10).
EN- 11
Figure 10. Inserting the electrode into the electrode guide tube
W a r n i n g : Ensure the electrode fully engages with the electrode isolation block. Improper engagement will disturb the normal flow of electricity and could harm the device, the doctor, and the patient. Note: Th e wo rk ing el ement c an acc ommoda te a va ri ety of scopes and electrodes. For a complete list of compatible instrumen ts, con tact a Stryker sale s represen tative. 3.
Slide the assembled working element, scope, and electrode (a) into the inner sheath (b) until the two pieces snap together (see Figure 11). Rotate the inner sheath until the guide pin locks into place.
Figure 11. Insert ing the worki ng ele ment, scope, an d electrode assembly into the inner sheath 4.
Connect a resectoscope cable to the RF cable connector (a) (see Figure 12).
Figure 12. Connecting resectoscope cable to the RF cable connector 5.
Connect irrigation tubing to the inflow port located on the inner sheath (a) and the outflow port located on the outer sheath (b) (see Figure 13).
Figure 13.
EN- 12
Connecting irrigation tube to the inflow and outflo w po rts
6.
After the surgical procedure, disassemble the resectoscope in reverse order from which it was assembled. Press the appropriate release button to separate the components of the resectoscope (see Figure 14).
Figure 1 4. Disassembl ing the re secto scope a. b. c. d.
releases the inner sheath from the outer sheath releases the working element from the inner sheath releases the electrode from the working element releases the scope from the working element Warning:
Before every surgical procedure, inspect the resectoscope, especially the ceramic tip and guiding element, for damage or cracks. Do not use the device if it shows protrusions or rough or sharp edges. Do not reuse single-use monopolar electrodes with the resectoscope. Physician and patient safety will be compromised. To maintain electrical isolation, use only Stryker electrodes and resectoscope cables. When urology hardware is used with other applied parts, total patient current leakage may be additive. Ensure BF conditions are observed when using the resectoscope with electromedical devices. Assembling the Urethrotome 1. Follow steps 1 – 3 of the previous section, “Assembling the Inner and Outer Sheaths with the Working Element, Scope, and Electrode,” substituting the urethrotome sheath and cold knives for the resectoscope sheaths and electrode. 2.
7.3
Follow steps 5 – 6 of the previous section for irrigation tube connection and disassembly.
Side Fire Laser Cystoscope System (GreenLight Laser)
Assembling the Scope, Visual Obturator, and Outer Sheath 1. Slide the scope (a) into the obturator (b) until the two pieces snap together (see Figure 15). 2.
Slide the assembly into the outer sheath (c) until the two pieces snap together.
EN- 13
Figu re 15.
Assembli ng the scope , visual obt ura tor, and outer sheath
Assembling the Sweep Guide (optional), Scope, Inner Sheath, and Outer Sheath 1. Line up the guide pin of the sweep guide (a) with the J-lock connection of the working port (b) (see Figure 16). 2.
Rotate the sweep guide clockwise until the connection is secure (90-degree turn).
3.
Slide the scope (c) into the inner sheath (d) until the two pieces snap together.
4.
Slide the inner sheath (d) into the outer sheath (e) until the two pieces snap together.
Figure 16.
Assembling the sweep guide (optio nal), scope, inner sheath and outer sheath
Inserting the GreenLight Laser Warn ing:
The GreenLight Laser is a Class 4 laser
product that emits potentially hazardous laser radiation. Prior to using the Laser in conjunction with the Side Fire Laser Cystoscope System, fully read, understand, and follow all warnings, cautions, and instructions provided in the Laser user manual. Improper assembly of the laser unit with the Side Fire Laser Cystoscope System may damage the fiber and expose the user and/or patient to harmful laser radiation. Follow the assembly instructions as stated in this manual as well as the instructions provided by the laser manufacturer. 1.
Open the working port (a) (see Figure 17).
EN- 14
C a u t i o n : The stopcock must be in the open position, or fiber damage may occur. 2.
Feed the fiber (b) of the laser through the working port of the sweep guide (c). If the sweep guide is not used, feed the fiber directly through the working port (a).
3.
Snap the white ball (d) of the laser into the sweep guide by aligning the notch on the ball with the arrow on the guide. W a r n i n g : Do not activate the GreenLight Laser until the blue arrow on the tip is visible on the monitor. Ensure the direction of the laser is known prior to activation in order to avoid damage to the scope. Refer to the Laserscope® user manual for instructions for use.
Fig ure 17.
Inserting the Gree nLight Laser
Removing the GreenLight Laser W a r n i n g : Ensure the laser is turned off prior to removal. 1.
Gently press down on the white ball (a) and withdraw the fiber completely from the sweep guide (see Figure 18). If the sweep guide is not used, withdraw the laser from the working port.
Figure 18.
Removing the GreenLight Laser
Disassembling the Scope, Sweep Guide, Inner Sheath and Outer Sheath 1. Remove the scope by pressing the speed lock button (a) and withdrawing the scope from the sheath (see Figure 19). 2.
Remove the sweep guide by rotating it counter-clockwise (90 degrees) and pulling it from the working port (b).
3.
Remove the inner sheath by pressing the speed lock button (c) and withdrawing it from the outer sheath.
EN- 15
Figure 19.
Disassembling the scope, sweep guide, inner sheath and outer sheath
8 �������� W a r n i n g : Urology hardware must be cleaned and sterilized prior to the first use and after every subsequent use. 1.
Prepare an enzymatic detergent solution according to the manufacturer’s instructions in warm water (38 – 48°C).
2.
Disassemble the hardware into its individual components (outer sheath, inner sheath, working element, etc.) I f cleaning flexible instruments, follow these additional steps: 2a. Lay units in a clean pan. Prepare an enzymatic detergent solution as recommended by the manufacturer. Add a sufficient amount of prepared solution to the pan to completely cover the instruments. 2b. Let the instruments soak for the recommended amount of time. This will reduce blood, protein, and mucus from the instruments.
3.
4. 5.
Rinse the hardware in lukewarm tap water. Use a mild enzymatic detergent and a soft brush to remove resistant debris and bioburden from all surfaces. Clean out interior spaces and guidance channels with an appropriate brush or cleaning pistol. Rinse off all soap residue with water. I f c l e a n i n g f l e x i b l e instruments, follow these additional steps: 5a. Immerse the instruments in a combination “milking” and mild detergent solution. This will prevent premature wear or instrument failure by lubricating the internal components. Follow the solution manufacturer’s recommended concentrations, temperatures, and exposure times. C a u t i o n : Do not use strong acidic or alkaline pH solutions, as instrument damage could result. 5b. Brush all instrument surfaces in both open and closed positions with a clean, soft-bristled, hand-held brush, keeping the instrument immersed in the cleaning solution while you brush. Brush any instrument channels or lumens thoroughly. C a u t i o n : Do not use strong acidic or alkaline pH solutions, as instrument damage could result.
EN- 16
5c. Thoroughly rinse and flush all parts and lumens with warm, running, demineralized water. 6.
Visually inspect the hardware to ensure that it has been thoroughly cleaned. Check joints, passages, and lumens for remaining protein deposits by placing hydrogen peroxide on these areas and observing for bubbles. In the case of persistent protein deposits, repeat steps 2b through 4.
7.
Dry the hardware thoroughly with a soft towel or gauze surgical sponge.
9 ������������� Warn ing: Allow flammable solvents and agents from cleaning/ disinfecting solutions to evaporate completely before using the hardware with the GreenLight Laser. Drying time depends on several variables, including altitude, humidity, type of wrap, preconditioning, size of chamber, mass of load, material of load, and placement in chamber. Users must verify that drying time set in their autoclave yields dry surgical equipment.
9.1
Autoclave System
1.
Clean and prepare the hardware as recommended in the Cleaning section. Ensure all components are disassembled and all stopcocks are in the open position.
2.
Sterilize the hardware using the following parameters. W a r n i n g : Immediate-use (or “Flash”) steam sterilization is intended only for emergency situations.
Pre-Vacuum Cycle
Immediate Use (“Flash”) PreVacuum Parameters (unwrapped)
US
EU
Double wrap*
Double wrap*
132 °C (270°F)
134°C (274°F)
4 minutes exposure time
3 minutes exposure time
45 minutes dry time
45 minutes dry time
132°C
134°C (274°F)
(270°F) 4 minutes sterilization time No dry time
3 minutes sterilization time No dry time
*Devices were validated wrapped in 2 layers of 1-ply polypropylene wrap (KimGuard KC600 - 510k K082554) 3.
Allow the hardware to completely dry before use. EN- 17
10 �������� ��������� This Stryker Endoscopy product is warranted to the original purchaser for a period of 90 days from the date of purchase to be free from defects in material and workmanship. This warranty extends to all purchases and is limited to the repair or replacement of the product without charge when returned to: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA Stryker Endoscopy cannot accept responsibility for returns or replacements which have not been authorized. This warranty does not cover damages caused by misuse or by failure to follow the procedures outlined in this manual or demonstrated by Stryker Endoscopy representatives. There are no other expressed warranties.
EN- 18
Produced For: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/ patents Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: t h e S t r y k e r L o g o . All other trademarks are trademarks of their respective owners or holders.
2016/10 WCR: P1.4
1000400685R