Certificado Periódico do Fabricante

ASSOC BENEFICIENTE DOURADENSE - HOSPITAL EVANGELICO DR E SRA GOLDSBY KING

Produto: Savina 300
N° de Série: ASEJ-0085
RUA HILDA BELGO DUARTE, 81
Versão de Software: 5.21
DOURADOS, MS 79806-020
N° Ordem de serviço: U507710150
N° Compra:
COMENTÁRIOS E CONCLUSÕES: 33
Data do serviço: 17/12/2018
MOTIVO DA VISITA TÉCNICA: Hospital Evangelico Dr. e Dra Geidaby King

Feito? Item Teste de fábrica Valor Feito? Item Teste de fábrica Valor
0 Savina 300 - IPM-L - 5.0 ok 4. 1. 4 General condition (Savina 300, accessories and special accessories) ok
1 Device configuration ok 4. 1. 5 Power supply unit ok
1. 1 Serial number ok 4. 1. 6 Filter cover ok
1. 1. 2 Expiratory valve 1 (reusable) ASEF-0507 4. 1. 7 Inspiratory block (inspiratory socket, nebulizer and temperature sensor connection) ok
1. 1. 6 (Option) Savina 300 trolley ASEH-0140 4. 1. 8. 1 Condition and function test ok
1. 2 Device data ok 4. 1. 8. 2 Flow sensor flap ok
1. 2. 1 PC-SIMV+/PC-BIPAP (YES / NO) YES 4. 1. 9. 1 Expiratory valve 1 (reusable) ok
1. 2. 3 (Option) PC-AC (YES / NO) YES 4. 1.10 Keypad, rotary knob, and display ok
1. 2. 5 AutoFlow (YES / NO) YES 4. 1.11 Adult test lung ok
1. 2. 6 NIV (YES / NO) YES 4. 1.12 O2 gas connecting tube ok
1. 2. 9 (Option) MonitoringPlus (YES / NO) YES 4. 1.13 (Option) Trolley (General condition) ok
1. 3 Software version, operating hours and service hours ok 4. 2 Function tests ok
1. 3. 1 Software version 5.01 4. 2. 1 Emergency respiratory valve (D2) -4,3 mbar
1. 3. 2 Operating hours 8217 h 4. 2. 2 Inspiration leak test 42 mbar
1. 3. 3 Service hours 8202 h 4. 2. 3 Reusable expiratory valve leak test ok
1. 4 Recording user-specific alarm limits ok 4. 2. 3. 1 Expiratory valve 1 (reusable) 40 mbar
1. 4. 1 MV high 24,9 4. 3 Function tests in service mode ok
1. 4. 2 MV low 3,0 4. 3. 1 Expiratory pressure sensor R1 flush flow ok
1. 4. 3 Paw 60 4. 3. 2 Blower control ok
1. 4. 4 VT 500 4. 3. 3 Non-return valve in expiratory valve (reusable) ok
1. 4. 5 AF 45 4. 3. 3. 1 Functional tests: Expiratory valve 1 (reusable) ok
1. 4. 6 Tapn 15 4. 3. 4 Pneumatic safety valve (D1) 105 mbar
2 Maintenance parts ok 4. 3. 5 Emergency expiratory valve (V8/V9) 5 mbar
2. 1 Maintenance intervals, overview ok 4. 3. 6 Nebulizer port ok
2. 1. 1 Maintenance intervals and required sets and parts ok 4. 3. 6. 1 Nebulizer flow 12 L/min
2. 2 Maintenance parts by specified interval ok 4. 3. 6. 2 Nebulizer pressure 2,1 bar
2. 2. 2 Savina 300 service set 2 years 17/12/2020 4. 3. 7 Comparison of flow sensor measurement functions ok
3 Electrical safety ok 4. 3. 8 Calibration classes ok
3. 2 Electrical safety according to IEC 60601-1 ok 4. 3. 9 O2 sensor and calibration valve V4 ok
3. 2. 1 Visual inspection ok 4. 3. 9. 1 O2-Sensor 1 cal valve (Off) 21 %
3. 2. 2 Protective earth resistance 0,093 Ohm 4. 3. 9. 2 O2-Sensor 1 cal valve (On) 100 %
3. 2. 3 Earth leakage current ok 4. 3.10 Keypad, LEDs and display ok
3. 2. 3. 1 Normal condition (N.C.) 176 µA 4. 3.11 Offset voltages of airway pressure sensors at ambient pressure ok
3. 2. 3. 2 Single fault condition (S.F.C.) 343 µA 4. 3.11. 1 02: V_PAW_INSP 0,73 V
3. 2. 3. 3 Normal condition (N.C.) 0,0 µA 4. 3.11. 2 03: V_PAW_EXP 0,73 V
3. 2. 3. 4 Single fault condition (S.F.C.) 178,9 µA 4. 3.12 Comparative measurement of absolute pressure sensors ok
4 Function and condition test ok 4. 3.13 Measurement difference between power supply unit and Central Control Board ok
4. 1 Condition tests ok 4. 4 Function tests in operation ok
4. 1. 1 Accompanying documents ok 4. 4. 1 Cooling air fan ok
4. 1. 2 Rating plates and option label ok 4. 4. 2 Power supply unit ok
4. 1. 3 Labels ok 4. 4. 2. 1 Electrical supply display ok

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ASSOC BENEFICIENTE DOURADENSE - HOSPITAL EVANGELICO DR E SRA Produto: Savina 300
GOLDSBY KING
RUA HILDA BELGO DUARTE, 81 N° de Série: ASEJ-0085
DOURADOS, MS 79806-020 N° Ordem de serviço: U507710150

4. 4. 2. 2 Internal supply voltage (internal batteries) ok 4. 8 User-specific alarm limits ok

4. 4. 2. 3 Power failure alarm ok 4. 8. 1 Input of user-specific alarm limits ok
4. 4. 4 Plausibility check of internal batteries (1) ok 4. 9. 1 Plausibility test ok
4. 4. 5 Micro-filter detection ok 4.10 Final procedures ok
4. 4. 6 RS232 interface ok 4.10. 1 Test label and device handover ok
4. 6 Dynamic final test in operation ok 5 Test equipment ok
4. 6. 1 Dynamic final test ok 5. 1 Test equipment list ok
4. 7 Log entries and operating hours meter ok 5. 1. 1 Test equipment subject to mandatory calibration ok
4. 7. 1 Deleting the log entries and resetting the operating hours meter ok

Servicing parts
Ok? Código Descrição da peça Qtd Ok? Código Descrição da peça Qtd
MX08860 Savina 300 Service Set 2y 1

Comentários e Conclusões Comentários e Conclusões

Realizado a manutenção preventiva do equipamento. Realizado a manutenção preventiva do equipamento.

Realizado a atualização do software para versão 05.10. Realizado a atualização do software para versão 05.10.

Realizado a TSB 12 - Atualização do software para versão 5.00 e TSB 13 - Realizado a TSB 12 - Atualização do software para versão 5.00 e TSB 13 -
Atualização do software para 5.01. Atualização do software para 5.01.

Realizado a troca do kit 02 anos P/N MX 08860. Realizado a troca do kit 02 anos P/N MX 08860.

Equipamento testado conforme check list e liberado para uso Equipamento testado conforme check list e liberado para uso

Instrumentos de medição utilizados

Serial Ferramenta utilizada Vencimento calibração Serial Ferramenta utilizada Vencimento calibração
100144512/10 Fluxômetro Triplo 15/01/2020 4778 Medidor de Oxigênio Teledyne MX300 13/03/2019
2959 Manômetro Digital (0 ...20 bar) 26/01/2019 4742 Verificador de segurança eletrica 22/01/2019

Data 17/12/2018 Instituição Hospital Evangelico Dr e Sra Goldsby King

Especialista de Serviços Leonardo H Alvarenga Reponsável Jackson J. Takahachi
Visto Visto

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