MEDIANA
HEART
ON
AED A16
Automated External Defibrillator
ii
ECG ..................................................................................................................................................... 49
Indication ............................................................................................................................................. 49
Physical ............................................................................................................................................... 49
Environmental Conditions.................................................................................................................... 50
Self Test ............................................................................................................................................... 50
Data Backup and Communication ....................................................................................................... 50
Expected Service Life .......................................................................................................................... 50
Accessories Specifications .................................................................................................................. 51
Defibrillation waveform ........................................................................................................................ 52
ECG Analysis Performance ................................................................................................................. 54
Compliance .......................................................................................................................................... 55
Manufacturer’s Declaration
................................................................................................................. 56
Figures
Figure 1. HeartOn A16: Top and Right Panel Components .......................................................................... 9
Figure 2. HeartOn A16: Rear Panel Components ....................................................................................... 10
Figure 3. Removing the battery ................................................................................................................... 19
Figure 4. Inserting the battery ..................................................................................................................... 20
Figure 5. Removing the battery protection sticker ....................................................................................... 20
Figure 6. Place the Adhesive Pad ............................................................................................................... 25
Figure 7. Replacing the CPR Feedback Module ......................................................................................... 26
Figure 8. Patient mode switch Button ......................................................................................................... 30
Figure 9. Pads disconnect icon (Chest type∙A16-DS, A16-DF) .................................................................. 31
Figure 10. Pads disconnect icon (Icon type∙A16-GS, A16-GF) .................................................................. 31
Figure 11. Action Icon – Step 1
(Left: Chest type∙A16-DS, A16-DF(
ⓑ
), Right: Icon type∙A16-GS, A16-GF(
ⓑ
) ............................ 32
Figure 12. Pads Placement ......................................................................................................................... 32
Figure 13. Action Icon – Step 2
(Left: Chest type∙A16-DS, A16-DF(
ⓒ
), Right: Icon type∙A16-GS, A16-GF (
ⓒ
) ........................... 33
Figure 14. Action Icon – Step 3
(Left: Chest type∙A16-DS, A16-DF (
ⓒ
,
ⓔ
), Right: Icon type∙A16-GS, A16-GF(
ⓒ
,
ⓔ
) ................. 34
Figure 15. Action Icon – Step 4
(Left: Chest type∙A16-DS, A16-DF(
ⓓ)
, Right: Icon type∙A16-GS, A16-GF(
ⓓ
) ............................ 35
Figure 16. Pads status icon ......................................................................................................................... 41
Figure 17. Use by date of Pads ................................................................................................................... 43
Tables
Table 1. HeartOn A16
Panel Components .................................................................................................. 10
Table 2. Panel and Label Symbols .............................................................................................................. 11
Table 3. Accessories.................................................................................................................................... 13
Table 4. The battery Status Icon .................................................................................................................. 21
Table 5. Electromagnetic Emissions (IEC60601-1-2) ................................................................................. 56
Table 6. Electromagnetic Immunity (IEC60601-1-2) ................................................................................... 56
Table 7. Electromagnetic Immunity (IEC60601-1-2) (continued) ................................................................ 57
Table 8. Recommended Separation Distances ........................................................................................... 58
Table 9. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2) ....... 59
Table 10. Cables (IEC60601-1-2) ............................................................................................................... 59
