Slim 7.5 Flexible Single Use Ureteroscope

Endoscopic Image Processor (model: HDVS-S100)

This endoscopic image processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

Single-use Flexible Ureteroscope

This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis.

Do not use this product for any other purposes.

Based on a thorough understanding of the endoscope specifications and functions listed here, select the desired endoscope according to the purpose of endoscopy and treatment.

Endoscopic Image Processor (model: HDVS-S100)

None.

Single-use Flexible Ureteroscope

• Patients with disease history of ureteral surgery or known ureteral stricture or urethral stricture
• Patients with disease history of pelvic surgery, radiotherapy, significant stenosis below the ureteral lesions, and bladder contracture
• Patients with difficulty of insertion during ureteroscope due to ureter fixation, stenosis, and fibrosis
• Patients with acute systemic infections
• Patients with acute urinary tract infections
• Patients with a bladder capacity of less than 50 ml
• Repeat the endoscopy in a short period of time is not advisable. Under normal circumstances, the second endoscopy will not be carried out within one week
• Patients with severe cardiopulmonary disease that cannot tolerate surgery
• Patients with uncontrolled coagulopathy
• Do not use any equipment that is not compatible with this device for diagnosis or treatment of proposed contraindications in any medical or health administrative institution or endoscopic society, or cases that do not fall within their prescribed indications

Single-use Flexible Ureteroscope

Do not use excessive force or make sudden bending operations. Do not pull, twist or rotate the angled bend section. Failure to do so may result in injury, bleeding or perforation of patient. It also causes the inability to straighten the bend section during the endoscopy.

When the endoscopic image is not displayed or the image is frozen, do not operate the bend section, insert or withdraw the insertion section of the endoscope, or use an endoscopic treatment accessory. Failure to do so may result in injury, bleeding and/or perforation of the patient.

Do not insert or withdraw the endoscope with excessive force or when the endoscope has a poor field of vision, as this may result in injury, bleeding and / or perforation of the patient.

Do not insert or pull out the insertion section suddenly or forcefully. If it is difficult to insert the endoscope, do not force the insertion; instead, stop the operation immediately. Failure to do so may result in injury, bleeding and/or perforation of the patient.

If the endoscopic image becomes dark during the operation, it may be because that blood or mucous membranes adhere to the distal end of the endoscope. The endoscope should be carefully withdrawn from the patient’s body to remove blood or mucous membranes, ensuring optimal illumination and safe operation. If user continue to use it in this situation, the temperature of the distal end will rise, causing burns to the patient’s mucous membranes. It may also cause injury to the patient and/or operator.

When the endoscopic image is not displayed on the monitor, the CMOS may be damaged. The endoscopic image processor should be turned off immediately. If the power is still applied for a long time in this case, the distal end of the endoscope becomes hot, causing burns to the operator or the patient.

Inspection of the Bending Function

• If the movement of the thumb lever is slack or unsmooth, or the bending of the bending section is not smooth, the bending function may be abnormal. In this case, do not use the endoscope as it may not straighten the bending section during the endoscopy, resulting in injury, bleeding and/or perforation of the patient.

Insert and Withdraw the Endoscope Accessory

• Do not forcedly or suddenly insert endoscopic treatment accessories. Otherwise, the endoscopic treatment accessories may suddenly protrude from the distal end of the endoscope, which may result in injury, bleeding, and/or perforation of the patient.
• When the endoscope is used in conjunction with an endoscope accessory with energy, the patient’s leakage current will increase, and the device needs to meet the requirement of leakage current, otherwise the patient may be at risk of it.
• Select to use the matching laser therapy accessories, otherwise, the image may not be displayed on the monitor when the laser is used. This can result in injury to the patient.
• If the tip and aiming beam of the laser probe haven’t seen in the endoscopic image, do not emit laser light, otherwise the patient may be injured and the plier’s tube may be damaged.
• Do not withdraw the laser probe when laser is emitted, otherwise the patient may be injured and/or the endoscope may be damaged.