The clinical practice result for Healthy applicant | |
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The clinical practice result for Healthy applicant Study and Result Existing IV infusion pump has been injected medicine using tube sequential peristaltic fluid control method. It can be deviation ±5%~20% per hour depending on tube material and elasticity. To overcome the this shortage, Anyfusion V-100 use specially designed round-type Cylinder cartridge that able to inject exact volume and exact rate.
This is tested for healthy applicant, compared cylinder type infusion pump Meinntech's Anyfusion V-100 and peistaltic flow control type Multinational company B's I device. Aim to know effectiveness through actual injected volume difference and safetiness through healthy applicant's observable symptoms or abnormal reaction.
Test result showed statistically meaningful difference on planned volume and injected volume both of physiological saline (0.9% NaCl) and glucose injection within Anyfusion V-100 and B multinational company I device. Anyfusion V-100 showed Injected volume deviation 0.51±1.2% on physiological saline and 3.22 ± 1.24 % on glucos and I device showed injected volume deviation 14.5 ± 3.77 % on physiological saline and 13.7 ± 3.06 % on glucose. Anyfusion V-100 showed considerably low deviation.
This test proved existing peristaltic flow control method reached ±5%~20% deviation. On the other hand cylinder type Anyfusion V-100 proved less than 5% deviation, which is far better than existing device. In this test, 1 applicant appeared a minor skin rash but it judged that this symptom is not related with medical device. Not appearing a significant abnormal reaction except that, this device can consider safe product.
In conclusion, after test of cylinder type infusion pump Meinntech's Anyfusion V-100 and peistaltic flow control type Multinaltion company B, I device, both device not appeared any significant abnormal reaction. And Anyfusion V-100 showed considerable low deviation rather than I device, so estimate that Anyfusion V-100 is more accurate and safe infusion pump. |
Next | Anyfusion cartridge set reclassified as new technology medical device from KFDA. |
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