1. Product name, model specification, structure composition
1. Product name: One-time use anoscope with light source
2. Model specification: HF-GMJ
3. Structure composition: The disposable anoscope with light source is composed of a mirror body, a handle, a light guide column, and a detachable light source. (Structural diagram is shown in Figure 1)
(1). Mirror body
(2). Handle
(3). Detachable light source
(4). Light guide
2. Classification of single-use anoscope with light source
Classified according to the type of electric shock protection: internal power supply equipment;
Classified by the degree of protection against electric shock: Type B application part;
Classified according to the degree of protection against ingress of liquid: IPX0;
The equipment cannot be used in the case of flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide;
Classified by operating mode: continuous operation;
The equipment does not have the application part to protect against the defibrillation discharge effect;
3. Normal working conditions of single-use anoscope with light source
Ambient temperature: +10℃～+40℃;
Relative humidity: 30%～80%;
Atmospheric pressure: 700hPa～1060hPa;
Power supply voltage: D.C. (4.05V~4.95V).
4. Contraindications for single-use anoscope with light source
Patients with anal and rectal stenosis;
Patients with acute infection or severe pain in the anus and rectum, such as anal fissures and abscesses;
Patients with acute severe colitis and severe radiation enteritis;
Patients with extensive adhesions in the abdominal cavity;
Patients with acute diffuse peritonitis;
Severe ascites, pregnant women;
Patients with advanced cancer accompanied by extensive intra-abdominal metastasis;
Patients with severe cardiopulmonary failure, severe hypertension, cerebrovascular disease, mental disorders and coma.
5. The performance of producing disposable anoscope products with light source
The anoscope has a smooth appearance, a clear outline, and has no defects such as burrs, flashes, scratches, and shrinkage. The anoscope should not crack after being subjected to a pressure of 50N, and the connection firmness between the scope and the handle should not be less than 10N.
The basic size of an anoscope unit: ㎜
Sixth, the scope of application of single-use anoscope with light source
This product is used for anorectal examination and treatment.
Seven, one-time use steps with light source anoscope
First wipe the outer surface of the detachable light source with 75% alcohol three times, press the switch, and then install it into the anoscope;
Disinfect the patient's anus;
Take out the anoscope, put the light source into the dilator hole, and apply paraffin oil or other lubricant on the dilator head;
Use the thumb and index finger of your left hand to pull open the right hip to reveal the anal orifice, press the anoscope against the anal orifice with the right hand, and massage the anal edge with the head of the expander. When the anus relaxes, slowly insert the anoscope toward the umbilical hole, and then change to the sacral recess after passing through the anal canal. At the same time, the patient needs to be instructed to breathe or defecate.
Take out the anoscope after the examination;
Separate the handle from the expander, take out the light source and turn it off;
The handle is assembled with the expander and then thrown into the medical waste bucket.
8. Maintenance and maintenance methods of one-time use anoscope with light source
The packaged product should be stored in a well-ventilated room with a relative humidity of no more than 80%, no corrosive gas, ventilation, and light-proof.
Nine, expiration date of single-use anoscope with light source
After this product is sterilized by ethylene oxide, the sterilization period is three years, and the expiration date is shown on the label.
10. List of accessories for single-use anoscope with light source
without
11. Precautions and warnings for single-use anoscope with light source
This device is only for qualified medical personnel to use in medical units.
When using this product, aseptic operation specifications should be strictly followed.
Before use, please check whether the product is within the validity period. The sterilization validity period is three years. Products beyond the validity period are strictly prohibited to use;
Please read this manual carefully before use, pay attention to the production date and batch number of the product, and do not use it after the expiry date.
Please check the packaging of this product carefully before use. If the blister packaging is damaged, please stop using it.
The storage period of the battery is three years. Please check the light source before use. Please replace the battery when the light is weak. The battery model is LR44.
This product is sterilized by ethylene oxide, and sterilized products for clinical use.
This product is for one-time use and cannot be sterilized after use;
This product is a one-time-use device, it must be destroyed after use, so that its parts no longer have the function of use, and undergo disinfection and harmless treatment. The electronic part should be treated as electronic equipment.
Post time: Jul-18-2021
