DR-12-04-3810-HASTABASI MONITORU

TORKAK
TURK AKREDiTASYON
KURUMU tarafmdan
akredite
ME.KAL
DENEY RAPORU
TEST REPORT
Karyagdl Sok. No: 14/1-2
06690 A.Ayrancl - ANKARA
Tel:
(312) 441 9208
Faks:
(312)4402538
MEDKAL
Laboratuvar
MQdOrlOgO
KIM MOh., Dan., Egitim, Ie; va DI§ Tic. Ltd.
E-Posta
medkal@kirn-tccom
Web Sites! : wwwklm-trcom
Deney ve Kalibrasyon
I
Daney larihi va yeri
Laboratuvarll
Deneyi
yapan
I Test
Test and Calibration
Date and place of test:
26.04.2012
Laboratory:
done
SorumlLJ/Responslble
by'
E. Ekrem OZCAN
Cihaz tammll Description:
Hastaba§1
Seri no J Serial no:
MonitorO
22338
imalatCI I Manufacturer:
BSM-2301K
adl-adresi I Customer:
S.B. KE<;ibREN
HASTANESII
Kullanllan
Modell Model:
KOHDEN
Cihaz sahibinin
EGITiM
Tanlm
Elektriksel
AMPS1
NIBP Analyzer
CLINICAL SMARTSAT
Metodu
standartlanna
I Test
Method:
tarafmdan
realize
k=2 ortme
faktoriJ
esas
ahnarak
Standarts)
and/or
NRS
(National
95% with the coverage
Cevre
$artlan
factor
(SP02)
Temmuz
12
AP03060299
Agustos
12
SS03952344
('**)
EN ISO 9919,TS
kullanllan
birimler
cihazlarln
EN 60601-2-27,TS
r,:lkl~lan;
olup, testi yapllan
hesaplanml~tlr.1
Reference
NIST
cihazdan
The outputs
Standards),
cihazmln
equipment
•.• Kalibrasyon
equipment
are traceable
•.•.• Kalibrasyon
cihazmm
are traceable
-
by Clinical
Kalibrasyon
calibration
Deney
izlenebllirtigi
{Nalionallnstitute
alman
bilgiler
of the test equipment
compared
I Ambient
with measured
of Standarts}
ile klyaslanml~tlr.
which
data.
are basic
ve/veya
Olrrilm
units
In the calculations
equipment
sonm;/arl,yukaflda
of uncertainities
: 23
Datrend
by Datrend
Systems
izlenebilirligi
Dynamics
are traceable
Systems
Dynamics
bilg/lerf
veri/en
(National
UMS
(Uzmanlar
cihaza
C1zerinden
NIST
(National
Institute
imzas,z
va miJhiirsiiz
The cerlifica/a
ya%111izni
sertiflkafar
shall nol be reproduced
o/madan
(National
seviyesi
Institute
confidance
ve
of
level is taken
+/-
2 °C
NIST
(National
Institute
(National
: 30 dak}min
time
(Physikalisch
Technishen
PTB (Physikalisch
Technishen
Institute
of
Bundesanstalt)'e
uzanmaktadlr-
I
beyan
Standards}'e
uzanmaktadlr.
I
The
calibration
Servisi)
of Standards)
Institute
uzerinden
Metrology
of Standards}'e
UME
(Ulusal
uzanmaktadlr
Metrotoji
Enstitilsil)'
I
The calibration
equipment
ye uzanmaktadlr
I The
Institute)
olunur.
are given above
veya
tamamen
kopya/amp
r;:oga/u/amaz.
gfMjersizdir.
partially or fully wilhoul Ihe penniss
ion of Ihe Jaboralory.CalibraNon
cerlificafes
without signature and seal areno/valid.
Not:
KL.F.01109
Rev.No: 03
The
Bundesanstalt)
of Standards)
Metroloji
UME (National
ait oldugu
klsmen
NIST
stabilization
PTB
through
Inc.
ijzerinden
NIST
by UMS Ltd. through
uzerinden
elektronik
Inc. through
Clinical
through
izlenebiliriigi
zaman I I Temp.
Elektronik
S,P.L.
ExpadmentalresullsareC()ncemed.vlththedevicewhichtheinfonnalions
Bu sertifika,laboratuvarm
Reference
%95 gQvenlik
by NIST
: 50+1-10%
S,P.L.
by Deutschland
izlenebilirligi
cihazlanmn
NRS {National
belirsizligi
realized
temperature
dengelenme
Almanya
are traceable
cihazmm
13
EN 60601-2-30,
conditions:
Slcakllk
Kalibrasyon
$ubat
k=2
I Environmental
Sicaklik
calibration
Mart 13
09020035
Nem / Humidity
*
Nisan 13
PS081 00087
("""*)
I
Gegerlik suresi
Due date
Serial no
1699GM300
(')
Analyzer
I
gore yapllmlstlr.
Deneyde
edilmi~
Seri no
M
Test Cihazi
Deney TS EN 60601-1,TS
TS EN 60601-2-34
I Description
(~
Pulse Oximeter
Parametre
KIMO HD150
used tizlenebilirliklTraceabilitvl:
GOvenlik Test Cihazi
Hasta Simulatoru
CLINICAL ACCUPULSE
Standards}
4055/12
Model
SPL GM300
Deney
VE ARA$TIRMA
ANKARA
standards
DATREND
AOlklama:
Sipari!} no J Order no:
denev standardlanlTest
Modell
Date of issue and no:
26.04.2012
UmitYARALI
NIHON
I
Rapor tarihi va no'su
Dahiliye Servisi
Sayfa 117
Oh;um
Raporu
I Measurement
Report
DR-12/04/3810
Marka:
1-
SP02
NIHON
Testi I SP02
A) Performans
Testi
Model:
KOHDEN
BSM-2301
K
Seri No: 22338
Test
I
Performance
Test
Modi
8P02
NablztRate
8P02
Nablzl
Rate
8P02
Nablz
I
Rate
8P02
NabltlRate
97 %
96%
60 BPM
60 BPM
o
90 %
90 %
0%
95 BPM
95 BPM
o
90 %
0%
45 BPM
45 BPM
o
80
80
0%
%
130 BPM
96 %
75 BPM
75 BPM
93
92 %
8P02
Nablzl
%
90 BPM
o
BPM
BPM
BPM
-1%
o
-1
90 BPM
o
2,457
1,133
2,325
1,440
2,325
1,024
2,107
1,789
2,457
BPM
1,257
%
2,369
BPM
1,393
TESTi
SP02
NABIZ
(%)
AItLimit
UstLimit
o
o
MEDKAL
%
97 %
NablzfRate
B) ALARM
BPM
90 %
130 BPM
8P02
-1 %
Alt Limit
- KiM MOh., Dan., ic ve 01$ TiC. Ltd.
o
(BPM)
Ust Limit
0
Say!a 2/7
C)ll;Om Raporu
I
Measurement
Report
DR-12/04/3810
Marka:
II - Solunum
A)
NIHON
Testil
Periormans
Model:
KOHDEN
Respiration
BSM-2301
K
Seri No: 22338
Test
Test! / Performance
Test
e.lirsizlik I
Mod/Mod.
RPM
15 RPM
RDena
1,0 Ohm
Elaseline
H
R Baseline
0,936
3D RPM
o
RPM
1,133
40 RPM
o
RPM
1,301
1000 Ohm
RPM
40 RPM
R Delta
1,0 Ohm
Bl. Baseline
1000 Ohm
TEST I
SP02
AltLimit
MEDKAL
RPM
3D RPM
1,0 Ohm
0
o
1000 Ohm
RPM
B) ALARM
15 RPM
NABIZ
(%)
Alt Limit
OstLimit
(BPM)
Ost Limit
0
- KiM MOh., Dan.,
il; ve DI~TiC;.
Ltd.
Sayfa
3/7
Olc;um
Raporu
1 Measurement
Report
DR-12/04I3810
Marka:
111- EKG
Testi
NIHON
KOHDEN
A) Performans
Testi
/ Performance
NSRYeti§kin
geliligi
80r0s)
ms)
NSR: Pedlatrik
(QRS,genhgi4Oms)
/Pedlatric
40
30 BPM
o aPM
0,936
60 aPM
o aPM
1,133
80 aPM
80 aPM
o aPM
1,301
100 aPM
100 aPM
o aPM
1,488
ms)
120 aPM
o aPM
1,687
180 aPM
180 aPM
o aPM
2,325
220 aPM
220
aPM
o aPM
2,769
240 aPM
240
aPM
o aPM
2,994
300 aPM
300
aPM
o aPM
3,677
30 aPM
30 aPM
o aPM
0,936
60 aPM
60 aPM
o aPM
1,133
80 aPM
80 aPM
o aPM
1,301
100 aPM
100 aPM
o aPM
120 aPM
120 aPM
o aPM
1,687
180 aPM
180 aPM
o aPM
2,325
220
aPM
220
aPM
o aPM
2,769
240
aPM
240
aPM
o aPM
2,994
300 SPM
300
SPM
o aPM
3,677
'"
'"
'"
'"
''""
'"
'"
2 H,
0,125
Hz
2,0 Hz
2,5 Hz
1,OmV
2,OmV
- KiM
22338
Atrial
Testll
Atrial
.~j~~:'~:~
~:I=~t~j;r
5 H,
MEDKAL
SeriNo:
30 aPM
10 Hz
B) Arrythmia:
K
60 aPM
120 aPM
IAdult
(QRSwidthl3Q
(CRS width
BSM-2301
Test
v.,••
(QRS
Model;
/ ECG Test
Test
Muh .. Dan .. ic ve DIs Tic.
Ltd.
1,488
..
D) Arrythmia:
I'J1Mf"'~~
~I1L1IiIReslJlt
0,6
mV
0,5
mV
0,5
mV
0,6
mV
Ventricular
Testi
''""
'"
'"
/ Ventricular
Test
$onu.;f~$l.Il.
'"
'"
''""
'"
Sayfa4/7
Oh;;um Raporu
I
Measurement
Report
DR-12/04/3810
Marka:
NIHON
IV- IBP Testi
Kanal1
A)
J
IIBP
Model:
KOHDEN
BSM-2301
Seri No: 22338
K
Test
CH 1
Statik Sasine Testi J Static Psessure
Test
-10 mmHg
-10 mmHg
a
a
mmHg
mmHg
a
mmHg
0,863
a
mmHg
0,849
80 mmHg
81 mmHg
1 mmHg
1,310
160 mmHg
161 mmHg
1 mmHg
2,118
240 mmHg
241 mmHg
1 mmHg
3,005
320 mmHg
321 mmHg
1 mmHg
3,918
400 mmHg
401 mmHg
1 mmHg
4,842
B) Dinamik
Baslne
Testi
I
Dynamic
Psessure
Test
121 mmHg
80 mmHg
121 mmHg
Radial
80 mmHg
121 mmHg
LVNT 120/00
a
mmHg
25 mmHg
RVNT 25/00
a
mmHg
25 mmHg
10 mmHg
10 mmHg
2 mmHg
14 mmHg
LATR1U
14/4
4 mmHg
15 mmHg
CVP 15/10
10 mmHg
MEDKAL
- KiM MOh., Dan.,
it; ve
01$
Tit;.
Ltd.
1,697
a
mmHg
1,301
1 mmHg
1,697
a
mmHg
1,301
1 mmHg
1,697
o mmHg
a mmHg
a mmHg
a mmHg
a mmHg
a mmHg
a mmHg
a mmHg
a mmHg
o mmHg
a mmHg
0,849
0,913
0,849
0,913
0,863
0,863
0,850
0,873
0,852
OI~Um Ra'poru / Measurement Report
DR·12/04/3810
Marka:
Model:
NIHON KOHDEN
Seri No: 22338
BSM·2301 K
v - NIBP Testi I NIBP Test
A) Performans Testi I Performance Test
G~::~,::::~:V
Mod'''''Od~
40
mmHg
60
51 mmHg
50 mmHg
76
mmHg
Yeti$klri DegerlEirU
Adult Presets
(8013PMl
(2~OOmmHgpPJ
120 mmHg
150 mmHg
mmHg
149 mmHg
150 mmHg
255 mmHg
mmHg
aiJllt$i:tllkl
Uilcertiliilty
2,346
C) Man$et Baslne Azalma Hizi Testi I Cuff Pressure Decrease Rate Test
Mod/Mode
5,00 mmHg
D ) Alarm Test
ALT liMiT
05T liMiT
MEDKAL - KIM MOh., Dan., Ie ve DI$ Tic. Ltd.
1,468
2 mmHg
1,253
3 mmHg
211 mmHg
191 mmHg
B ) CUT-OFF TESTI
Hava Sizma Oranl f Air leak
Rate
f----
1 mmHg
252 mmHg
215
195 mmHg
1,062
4 mmHg
164 mmHg
mmHg
1,253
2 mmHg
-1 mmHg
196 mmHg
166
0,995
1 mmHg
114 mmHg
101 mmHg
200 mmHg
1,129
3 mmHg
-1 mmHg
149 mmHg
116
0,944
1 mmHg
90 mmHg
81 mmHg
100 mmHg
1,044
-3 mmHg
2 mmHg
119 mmHg
93 mmHg
80 mmHg
0,915
4 mmHg
79 mmHg
63 mmHg
65 mmHg
0,998
-3 mmHg
-1 mmHg
96 mmHg
100 mmHg
0,870
-2 mmHg
63 mmHg
mmHg
0,927
-1 mmHg
4 mmHg
82 mmHg
80 mmHg
li~:':!~'::~~
4 mmHg
41 mmHg
26 mmHg
30 mmHg
" :::'W"
••"l<OIWV" ••
56 mmHg
60 mmHg
f----
4 mmHg
1,748
4 mmHg
1,444
Ol~(jm Raporu
1 Measurement
Report
DR-12/04/3810
Marka:
VI - Sicakhk
T1 Clkl$I'
NIHON
Testi 'Temperature
KOHDEN
Model:
BSM-2301
K
Seri No:
22338
Test
T1 Output
30,0°C
30,0°C
O,O°C
0,311
35,0°C
35,0°C
O,O°C
0,311
37,0°C
37,0°C
O,O°C
0,311
40,0°C
40,0°C
0,0 °C
0,311
42,0°C
42,0°C
O,O°C
0,311
S.caklikl
Temper3ture
Alarm Testi
MEDKAl
- KiM Muh., Dan., i~ ve
Ol§
Ti~. ltd.
Sayfa 7/7