gimaitaly KM-221 Blood Pressure cuff Instructions
- June 5, 2024
- gimaitaly
Table of Contents
gimaitaly KM-221 Blood Pressure cuff
Introduction
Product name: Blood Pressure Cuff
Product model and configuration: KM series (reusable cuff):
Model
| Applicable to| Application
site
| Limb circumference
---|---|---|---
KM-221| Infant| ****
Arm
| 6cm – 11cm
KM-222| Infant| 8cm – 13cm
KM-232| Child| 10cm – 19cm
KM-233| Child| 18cm – 26cm
KM-241| Adult| 21cm – 35cm
KM-242| Adult| 27cm – 42cm
KM-243| Adult| 40cm – 48cm
KM-244| Adult| Thigh| 46cm – 66cm
KM-333| Child| ****
Arm
| 18cm – 26cm
KM-341| Adult| 21cm – 35cm
KM-342| Adult| 27cm – 42cm
KM-343| Adult| 40cm – 48cm
Service life: 2 years
KN series (reusable cuff):
Model
| Applicable to| Application
site
| Limb circumference
---|---|---|---
KN-221| Infant| ****
Arm
| 6cm – 11cm
KN-231| Child| 10cm – 19cm
KN-233| Child| 18cm – 26cm
KN-241| Adult| 25cm – 35cm
KN-243| Adult| 33cm – 47cm
KN-244| Adult| Thigh| 46cm – 66cm
Intended use: The blood pressure cuff is indicated for use in manual measurement and automatic non- invasive blood pressure monitoring. It’s applicable to be used with a compatible monitor
Instructions for use
- Appropriate cuff should be selected according to the age and arm/thigh circumference of the subject. Its width should be 2/3 of the length of the upper arm/thigh. The inflatable part should be long enough to permit wrapping approximately 80% of the limb. When cuff sizes overlap for a specified circumference, choose the larger size.
- Check the cuff before use, replace the cuff when aging, tearing or weak closure is apparent. Do not use a damaged cuff. Select the appropriate blood pressure measurement site. Inspect patient’s limb prior to application.
- When applying the cuff, unfold and wrap around the upper arm/thigh evenly to the appropriate tightness.
- The cuff should be tightened to a degree where insertion of one finger is allowed
- Locate the cuff in such a way that the artery mark is at a location where the clearest pulsation of brachial artery is observed.
- Remember to empty any residual air in the cuff before the measurement is commenced.
Operating Environment
Ambient temperature range: -10℃~ 40℃; Relative humidity: 10%~85%; Atmospheric pressure: 50kPa ~106.0kPa The cuff should be stored and used within the specified temperature and humidity range, or it may cause damage to the cuff or inaccurate measurement results.
Cleaning and Disinfection
- Prepare the enzymatic detergent or equivalent and distilled water, and 10% bleach solution in separate spray bottles.
- Spray detergent liberally on cuff, tubing and hose. If dirt is dried on, allow the detergent to soak in to the cuff for one minute.
- Wipe smooth surface with a soft cloth. Use a soft-bristle brush on visibly stained areas and irregular surfaces. Note: Take particular care when cleaning the bulb and control valve knob on a complete inflation system. Do not allow fluid to enter back valve or saturate control valve knob. Remove visible contaminants from the periphery and the underside of the control valve knob.
- Rinse with copious amounts of distilled water.
- To disinfect, spray 10% bleach solution on cuff until saturated and allow to soak for five minutes.
- Wipe away excess solution and rinse again with distilled water. Allow cuff to air dry
Warnings and Precautions
- Blood pressure measurement is prohibited to those who have severe hemorrhagic tendencies or with sickle cell disease, as partial bleeding may be caused.
- Continuous measurement may result in purpura, neuralgia and lack of blood.
- Do not place the cuff on limbs with transfusion tubes, intubations or skin lesions on the area, as damage may be caused to the limbs.
- Avoid compressing or restricting the connection tubing.
- Minimize limb movement and cuff motion during measurement.
- Check the site and limb frequently, especially when monitoring at frequent intervals and/or over extended periods of time.
- Remove the cuff from the patient when the measurement has been taken.
- Use cuff only under direct supervision by trained healthcare professional when attached to automated monitors without alarms.
- Before use, empty the cuff until there is no residual air inside.
- Do not allow the cuff to twist or bend. Do not twist the cuff hose or put heavy things on it.
- Please hold the connector of the hose while connecting and disconnecting it to the device.
- If arrhythmia or auricular fibrillation occurs, take the measurement again.
- Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the
- Member State in which the user and/or patient is established.
| Medical Device compliant with Regulation (EU) 2017/745| | Product code
---|---|---|---
| Manufacturer| | Authorised representative in the European Community
| Medical device| | Caution: read instructions (warnings) carefully
| Follow instructions for use| | Date of manufacture
| Temperature limit| | Humidity limit
| Atmospheric pressure limit| | Expiration date
| Lot number| |