Chapter 6: Product Specification 


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Chapter 6: Product Specification



Product Name: Baby Sound Pocket Fetal Doppler

Model No.: Baby Sound A/B

Safety: Complies with: IEC 60601-1:2005

Classification:

Anti-electroshock Type: Internally powered equipment.

Anti-electroshock Degree: Type В applied part.

Harmful Liquid Proof Degree: Ordinary equipment (sealed equipment without liquid proof)

Main unit: Degrees of protection provided by enclosure: IPXl

Degree of Safety in Presence of Flammable Gases: Equipment not suitable for use in presence of flammable

gases

Working System: Continuous running equipment EMC: Group I Class В

Suitable Using Range: Suitable for use after the 12th week of pregnancy

Physical Characteristic:

Size: (L) 110 mm x (W) 55 mm x (H) l6.8 mm

(the space between probe culmination and upper panel is 26 mm)

Weight: About 80 g (including batteries)

Environment:

Working:

Temperature: +5°C ~ +40°C

Humidity: <80%

Atmospheric Pressure: 70 kPa ~ 106 kPa

Transport and Storage:

Temperature: -10°C ~+55°C

Humidity: <93%

Atmospheric Pressure: 50 kPa ~ 106 kPa

Battery Type Recommended: 1.5V DC alkaline Battery x2 (Size: AAA)

LCD Dispiay: 25 mm x 14 mm (Baby Sound В only)

FHR Performance: (Baby Sound В only)

FHR Measuring Range: 50 BPM ~ 240 BPM (BPM: beat per minute)

Resolution: 1BPM

Accuracy: ±2 BPM

Power Consumption: <1W

Probe:

Nominal Frequency: 2.0 MHz

Working Frequency: 2.0 MHz ± 10%

P.: < 1 MPa

Iob: < 20 mW/cm2

Ispta: < 100 mW/cm2

P: < 20 mW

Working Mode: Continuous wave doppler

Effective Radiating Area of Transducer: < 208 mm2

Note: In all working application modes, mechanical index: MI < 1, thermal index: TI < 1

 

Chapter 7: Maintenance

The device is frangible and must be handled with care. Gel must be wiped from the probe after use. These precautions will prolong the life of the unit. The user must check that the equipment does not have visible evidence of damage that may affect patient safety or Pocket Fetal Doppler capability before use. The recommended inspection interval is once per month or less. If damage is evident, replacement is recommended before use. The device should undergo periodic safety testing to insure proper patient isolation from leakage currents. This should include leakage current measurement. The recommended testing interval is once every two years or as specified in the institution’s test and inspection protocol. The accuracy of FHR is controlled by the equipment and can not be adjusted by user. If the FHR result is distrustful, please use other methods such as stethoscope to verify immediately or contact local distributor or manufacture to get help.

 

Chapter 8: Cleaning, Disinfecting and Sterilization

Cleaning

Before cleaning, switch off the power and take out the batteries. Keep the outside surface of the device clean and free of dust and dirt, and clean exterior surface of the chassis with a dry, soft cloth. If necessary, clean the chassis with a soft cloth soaked in a solution of soap or water, and wipe dry with a clean cloth immediately.

1. Don’t use strong solvent, such as acetone.

2. Never use an abrasive such as steel wool or metal polish.

3. Do not allow any liquid to enter the product, and do not immerse any parts of the device into any liquids.

4. Avoid pouring liquids on the device while cleaning.

5. Don’t remain any cleaning solution on the surface of the device.

Disinfecting and Sterilization

Wipe the surface of probe with 70% ethanol, self-air dry, or clean with a clean, dry cloth.

Notes:

1. Never try to sterilize the equipment by low temperature steam or other methods.

2. Do not use high temperature sterilizing process and E-beam or gamma radiation sterilization.

3. The recommended periods of cleaning, sterilization and disinfecting are once per month.

4. After cleaning, sterilization and disinfecting, users must inspect whether have any obvious damage which could affect the patient safety and instrument performance possibly.

 



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