TORKAK ME.KAL

TORKAK
TURK AKREDiTASYON
KURUMU taraflndan
akredite
ME.KAL
DENEY RAPORU
TEST REPORT
Karyagdl Sok. No: 14/1-2
06690 A.Ayrancl - ANKARA
Tel
(312) 4419208
Faks
(312) 440 25 38
MEDKAL
Laboratuvar
MUdUrlUgU
KIM MOh., Dan., Egitim, It;: ve DI~ Tic. ltd.
E-Posta
medkal@klm-tr corn
Web Sitesi
www klrn-tr com
Deney ve Kalibrasyon
Deneylarihi
Laboratuvarll
02.05.2012
Deneyi
Test and Calibration
veyeri I Dale and place of test:
yapan
Laboratory:
Raporlarihi
ve no'sul
I
Responsible:
Genel Yogun Baklrn
I Test done
by:
UmitYARALI
Cihaz tammll
E. Ekrem OZeAN
Description:
Seri no I Serial no:
Hastaba~1 MonitOru
5513698661
imalatt;1 I Manufacturer:
Modell Model:
DRAGER
INFINITY
Cihaz sahibinin adl-adresi I Customer:
S.B. KE<;16REN EGITIM
HASTANESI / ANKARA
Kullamlan
denev
Modell
DATREND
Tanlm
Elektriksel
AMPS1
DATREND
OXITEST
AClklama:
Denoy
I Test
taraflndan
Parametre
Method:
realize
fakltiru
esas allnarak
and/or
NRS (National
ljartlan
Sed no
I Serial
Geyerlik
no
1699GM300
Tesl Gihazi (')
Nisan 13
PS081 00087
Temmuz
9143013
(SP02)
Temmuz
09020035
EN ISO 9919,TS
EN 60601-2-27,TS
12
:;;ubat 13
DOS09031029
Analyzer(")
I
suresi
Due date
12
:;;ubat 13
EN 60601~2-30,
gore yapllml$tlr.
Deneyde
edilmi~
k=2 ortme
Standarts)
Cevre
I Description
Test Cihazl (•••.)
EN 60601~1,TS
standartlanna
95% with the coveragefaclor
-
(izlenebilirlikITraceabilitvl:
(")
Pulse Oximeter
DeneyTS
Metodu
Standards)
used
NIBP Analyzer{"')
KIMO HD150
TS EN 60601-2~34
Guvenlik
Hasta SimulatOru
BP PUMP-2L
4055/12
standards
Model
VISTA
Sipari§ no I Order no:
VE ARASTIRMA
standardlarilTest
SPL GM300
FLUKE
Dale of iS$ue and no:
02.05.2012
Sorumlu
kullamlan
birimler
olup,
hesaplanml~tlr.
Reference
cihazlann
9Ikl~lan;
testi yapllan
I The
outputs
Standards),
cihazdan
NIST
(National
alman
bilgiler
of the test equipment
compared
with measured
Institute
of Standarts)
Ue klyaslanml~tlr.
which
data.
are basic
units
ve/veya
Oll(um
realized
In the calculations
NRS (National
belirsizligi
by NIST
of uncertainities
Reference
%95 guvenlik
(National
seviyesi
Institute
confldance
ve
of
level is taken
k=2.
I Environmental
conditions:
Sicakilk
I Ambien!
: 23 +/~ 2 °C
temperature
: 50
Nem I Humidity
S'cakllk
dengelenme
zaman
I
I Temp.
stabilization
• Kalibrasyon cihaz'n1n IzlenebiliriiOi Almanya S.P.L. Elektronik uzerlnden PTB (Physikalisch Technishen
traceable by Deutschland S.PL elektronikthrough
PTB (Physikaii schTechnishenBundesanstalt)
•• Kalibrasyon cihazlnln izlenebilirli!li Datrend Systems Inc. uzerinden
Datrend Systems Inc. through NIST(National
InstituteofSlandards)
time
Bundesanstalt)'e
NIST (National Institute of Slandards)'e
+1-10 %
: 30 daklmin
uzanmaktad,r.!
uzanmaktad<r.!
The calibration
The calibration
equipment
equipment
are
are traceable
by
••• Test cihazlnln izlenebilirliOi MEOKAL- KIM Ltd. $ti, iizerinden PTB (Physikalisch Technische Bundesanslalt)'e
uzanmaktadlf.!
The test equipments are traceable by
MEDKAL-KIMLtd.
$ti,through PTB{Physikalisch
Technische Bundesa nstalt) .
•••• Kalibrasyon cihazlannln izlenebilirli!li
UMS (Uzmanlar Melroloji Servisl) iizerinden UME (Uiusal Metrolaji Enstitiisiij" ye uzanmaktadlr. I The calibration equipment
are traceable by UMS Ltd, through UME (National Metrology Institute).
Deney sonu~fan,yukanda bifgileri veri/en cihaza ait ofdugu beyan ofunur.
Experimental
results are concerned
with tile device whiCh the informations
are given above
Bu sertifika,laboratuvann yazllI izni o/madan klsmen veya tamamen kopya/amp t;oga/il/amaz.
Imzaslz ve miihiirsiJz sertifika/ar get;ersizdir.
The certiFicatesIJallno/be
reproduced
partially or fully wi/haut tlJeperm issionof/heiaboralary,Callbra/ioncertmcateswi/houtsignMureandsealarena/valid,
Not:
Kl.F.01/09
Rev.No:
03
Sayfa
1/6
Oh;iim
I
Raporu
Measurement
Report
DR-12/05/141
Marka:
I-SP02
Model:
DRAGER
Testi I SP02
INFINITY
VISTA
Seri No: 5513698661
Test
A) Performans Testi I Performance Test
60 BPM
60 BPM
o
90 %
90 %
0%
95 BPM
95 BPM
o
90 %
0%
45 BPM
45 BPM
o
80%
80 %
0%
2,107
o
1,789
90
NablzlRate
130 BPM
51"02
Nabl~fRat~
B) ALARM
130 BPM
97 %
96%
75 BPM
75 BPM
93 %
92 %
90 BPM
90 BPM
BPM
BPM
BPM
-1 %
o
BPM
-1 %
o
BPM
1,133
2,325
1,440
2,325
1,024
2,457
1,257
2,369
1,393
TESTI
5P02
(%)
AltLimit
UstLimit
I']
I']
MEDKAl
0/0
BPM
- KiM Muh.,
Dan., Ie ve
AltLimit
I']
DI' Til;. ltd.
OstLimit
I']
Sayfa 2/6
C)l~iim Raporu 1 Measurement Report
DR-12105/141
Marka: DRAGER
11- Sol
Model:
INFINITY
VISTA
Seri No: 5513698661
Testil Respiration Test
unum
A) Performans
Testi
I
Performance
Test
1,0 Ohm
RBase:line:
15 RPM
o RPM
0,936
30 RPM
o RPM
1,133
40 RPM
o RPM
1,301
1000 Ohm
RPM
30 RPM
RDeita
1,0 Ohm
1000 Ohm
40 RPM
1,0 Ohm
1000 Ohm
B)ALARM
TESTI
SP02
0
MEDKAL
NABIZ
(%)
AltLimit
- KiM Mlih"
Alt Lim'd
OstLimit
(BPM)
Ost Limit
0
Dan.,
i~ve
01$
Ti~.ltd.
Sayfa 3/6
ell~um
Raporu
I Measurement
Report
DR-1210S/141
Marka:
III • EKG
Testi'
A) Performans
Model:
DRAGER
INFINITY
VISTA
Seri
No:
5513698661
ECG Test
Testl
J Performance
Test
1'' 'i>''~jI'' .,
V"o.
NSeV,',,'O
IAdu"
, ~~R."','a'"
,!P'dial''''
~:::~J
30 BPM
o BPM
0,936
60 BPM
60 BPM
o BPM
1,133
80 BPM
80 BPM
o BPM
1,301
100 BPM
100 BPM
o BPM
1,488
120 BPM
;20
BPM
o BPM
1,687
30 BPM
180 BPM
180 BPM
o BPM
2,325
220 BPM
220
BPM
o BPM
2,769
240 BPM
240
BPM
o BPM
2,994
300 BPM
300
BPM
o BPM
3,677
30 BPM
30 BPM
o BPM
0,936
60 BPM
60 BPM
o BPM
1,133
80 BPM
80 BPM
o BPM
1,301
100 BPM
100 BPM
o BPM
1,488
120 BPM
120 BPM
o BPM
1,687
180 BPM
180 BPM
o BPM
2,325
220
BPM
220
BPM
o BPM
2,769
240
BPM
240
BPM
o BPM
2,994
300
BPM
300
BPM
o BPM
3,677
~l)~lu;·.f·.~E!~~lt
10 Hz
2 H,
0,125
Hz
2,0 Hz
0,8
mV
121
0,5
mV
121
0,5
mV
121
0,8
mV
121
2,5 Hz
D) Arrythmia:
1,0 mV
Atrial
Testi'
Atrial
Testi'
Ventricular
Test
$QI:Jk.l~'~~lIlt
2,0 mV
B} Arrythmia:
Ventricular
121
Test
121
o
121
o
MEDKAL·
KiM Muh .. Dan ..
Ic
va DIS
Tic.
Ltd
Ol~i.im Raporu I Measurement
Report
DR·12/05/141
Model:
Marka: DRAGER
INFINITY VISTA
Seri No: 5513698661
IV - NIBP Testi I NIBP Test
A) Performans Test'l! Performance Test
.," ,;OJ;
••••~J~'M'~
60 mmHg
"".i'
63 mmHg
100 mmHg
65 mmHg
Aj~~'~i~
2 mmHg
100 mmHg
150 mmHg
-1 mmHg
195 mmHg
1,468
3 mmHg
1 mmHg
251 mmHg
215 mmHg
1,062
4 mmHg
163 mmHg
149 mmHg
255 mmHg
1,253
2 mmHg
196 mmHg
166 mmHg
0,995
1 mmHg
114 mmHg
101 mmHg
200 mmHg
1,117
3 mmHg
-1 mmHg
149 mmHg
116 mmHg
0,944
4 mmHg
90 mmHg
81 mmHg
150 mmHg
1,044
-3 mmHg
116 mmHg
93 mmHg
80 mmHg
0,915
4 mmHg
79 mmHg
63 mmHg
120 mmHg
0,998
-1 mmHg
96 mmHg
76 mmHg
0,874
-3 mmHg
51 mmHg
50 mmHg
0,927
-2 mmHg
82 mmHg
60 mmHg
211 mmHg
191 mmHg
tm~rtaihfu
-1 mmHg
1 mmHg
29 mmHg
80 mmHg
.••
4 mmHg
41 mmHg
40 mmHg
30 mmHg
a91ii'Si~k}
••ili~~~
,V.'M
56 mmHg
~
1,253
1,743
4 mmHg
4 mmHg
1,444
B ) CUT-OFF TESTI
C) Man$et Baslnr; Azalma
HIZI
Testi { Cuff Pressure Decrease Rate Test
4,00 mmHg
D) Alarm Test
ALT LIMIT
05T LIMIT
MEDKAL - KiM MOh., Dan., It; ve Dl§ Till. Ltd.
Savfa
5/6
Ctl~(jm
Raporu
I Measurement
Report
DR-12/05/141
Marka:
v . Sicakllk
DRAGER
Testi I Temperature
Model:
INFINITY
VISTA
Seri No:
5513698661
Test
T1 Clkl§11 T1 Output
30,0 "C
30,0 "C
0,0 "C
0,311
35,0 "C
35,0 "C
0,0 "C
0,311
37,0 "C
37,0 "C
0,0 "C
0,311
40,0 "C
40,0 "C
0,0 "C
0,311
42,0 "C
42,0 "C
0,0 "C
0,311
Alar-rnTes{i
MEDKAL
- KiM MOh., Dan"
icY. 0" Ti~. Ltd,
Say!a
6/6