DR-12-04-3368-HASTABASI MONITORU

TORKAK
TURK AKREOiTASYON
larafmdan akredile
KURUMU
ME.KAL
DENEY RAPORU
TEST REPORT
Karyagdl Sok. No: 14/1-2
06690 AAyrancl
• ANKARA
Tel
(312)4419208
Faks : (312)4402538
MEDKAL
Laboratuvar
MQdOrlQgO
KiM MOh., Dan., Egitim, Ie ve DI§ Tic. Ltd.
E-Posta
medkal@klm-trcom
Web Sites;
: www klm-Ir com
Deney ve Kalibrasyon
I
Daney tarihi va yeri
Laboratuvan
I Test and Calibration
Date and place of test:
25.04.2012
Laboratory:
Genel Cerrahi Servisi
Sorumlu/Responsible:
Ercan DEMiR
E. Ekrem
Cihaz tanlmll Description:
Hastaba§l
14057
Modell
BSM-230'K
adl-adresi I Customer:
S.B KE(:IOREN
EGITiM
HASTANEslr
ANKARA
standards
Tanlm
DATREND
ElektrikseJ
AMPS,
Hasta SimUlat6rO
CLINICAL SMAATSAT
DeneyTS
TS EN 60601·2-34
Deney
Metodu
Standards)
Method:
realize
k"'2 Clrtme faktoro
esas
ahnarak
NRS
(National
95% with the coverage
Cevre ~artlarl/
factor
kullanllan
birimler
Reference
calibration
""
equipment
Karlbrasyon
equipment
are traceable
•.•.•.• Kalibrasyon
calibration
Deney
izlenebilirligi
cnazmm
sonu¢afl,yukanda
imzaslz
ve mlihlirs{Jz
EN 60601-2-27,TS
Mart 13
$ubat
13
EN 60601-2-30,
NIST
cihazdan
(National
alman
Institute
bilgiler
data,
vefveya
of Standarts)
ile klyaslanml~lr.
which
with measured
are basic
Oleum
units
In the calculations
NRS (National
belrrsizligi
realized
by NIST
of uncertainities
%95
Reference
gOvenlik
seviyesi
(Nationallnslilute
confidance
ve
of
level is taken
Systems
yazi/J
zaman I I Temp.
Elektronik
S,P.L.
Dynamics
Qzerinden
NIST
(National
iJzerinden
(Nalionallnstitute
UMS
(Uzmanlar
cihaza
o/madan
Metroloji
UME
ait oldugu
fusmen
NIST
vera
stabilization
PTS
PTS (Physikalisch
NIST
(National
Institute
: 30 dak/min
time
(Physikalisch
Technishen
Technishen
Institute
Sundesanstalt)'e
I
uzanmaktadlr
of Standards)'e
uzanmaktadlf,
f
The
calibration
of Standards)
(National
Servisi)
(National
Institute
beyan
are
uzerinden
Metrology
of Standards}'e
UME
(Ulusal
uzanmaktadlr,
Metroloji
I The
EnstitOsQ)'
calibration
equipment
ye uzanmaktadlr.
I
Institute)
olunur.
giVen above
tamamen
kopyalamp
r;o(JaltIfamaz.
ger;ersizdir.
The certificate shall nol be reproduc"dpartiallyorfullywilhoutthe
pe nnossionofthelaboratoryCe/ibrationcerlificateswilhoutsigne/Ureandsealerenotvalid.
Not:
KL.F.01/09
Rev.No: 03
The
Bundesanstalt}.
of Standards)
with the device whiCh the informations
izni
through
Inc.
NIST
veri/en
Ozerinden
elektronik
Systems
by UMS Ltd, through
bUgileri
seltifikafar
:50+/-10%
S.P.L.
Inc. through
Clinical
through
izlonebilirligi
are traceaale
: 23+1-2°C
temperature
dengelenme
Datrend
izlenel:i1irrlgi
Experiment~1 results are concerned
Bu serlifika,faboratuvann
S503952344
('**)
of the test equipment
compared
I Ambient
by Deutschland
by Datrend
Dynamics
cihazlannln
equipment
12
1 Humidity
clhazmmlzlenehilirligi
by Clinical
12
Agustos
conditions:
Almanya
are Iraceaole
are traceable
""" KalibraSyQn
Temmuz
09020035
Clkl~lan;
The outputs
Standards),
Sicaklik
cihazmm
PS08'OO087
k=2
Environrnental
Nem
Kalibrasyon
cihazlarm
olup, testi yapllan
hesaplanml~tlr./
Sicaklik
*
Analyzer
Nisan 13
AP03060299
Test Cihazi (•••.•)
1
Ge<;:erfik sUresi
Due date
no
g6re yapIJml$tlr.
Deneyde
ed;lmi~
Standarts)
and/or
(SP02)
1 Serial
1699GM300
(**)
EN 60601-1 ,TS EN ISO 9919,TS
standartlarlna
I Test
tarafmdan
Ser; no
(*)
('**)
Pulse Oximeter
Parametre
KIMO HD150
used tizlenebilirliklTraceabilitvl;
I Description
GUvenJik Test Cihazi
NJBP Analyzer
CLINICAL ACCUPULSE
AC;lklama:
4055/12
Model
SPL GM300
no' Order no:
Siparilj
VE ARA~T1RMA
denev standardlanITest
Model'
Model:
KOHDEN
Cihaz sahibinin
OZeAN
Seri no I Serial no:
Monitoru
imalatCI! Manufacturer:
Kullanllan
Date of issue and no:
25.04,2012
Deneyiyapan/Testdoneby
NIHON
I
Aapor tarihi va no'su
Sayfa
1/6
The
Ol~um
Raporu
I Measurement
Report
DR-12/04/3368
Marka:
I - SP02
Testi
A) Periormans
NIHON
I SP02
KOHDEN
Model:
BSM-2301
K
Seri No: 14057
Test
Testi / Periormance
Test
RealValue
SP02
Nablzl
Rate
SP02
Nabit f Rate
SP02
Nabrz!Rate
SP02
NablztRate
0%
60 BPM
o
90 %
90 %
0%
95 BPM
95 BPM
o
90 %
90 %
0%
45 BPM
45 BPM
o
80 %
80
0%
SP02
Nablz! Rate
%
130 BPM
97%
Nablz I Rate
o
BPM
BPM
BPM
BPM
2,479
1,133
2,325
1,440
2,325
1,024
2,107
1,789
97 %
0%
75 BPM
75 BPM
o
93 %
93 %
0%
2,391
90 BPM
90 BPM
o
1,393
BPM
BPM
2,479
1,257
TESTi
SP02
AltLimit
[]
97 %
60 BPM
130 BPM
SP02
B) ALARM
97%
(%)
NABIZ
IOstLimit
I
Aft Limit
(BPM)
Ost Limit
[]
MEDKAl- KiM Mlih., Dan., i~va
D., Ti~. Ltd.
Sayfa 2/6
Olc;Om Raporu
/ Measurement
Report
DR-12/04J3368
Marka:
II - Solunum
NIHON
Testil
A) Pertormans
Respiration
Testi
I
Model:
KOHDEN
Pertormance
BSM-2301K
Seri No:
14057
Test
Test
Mod I Mode
15 RPM
RPM
1,0 Ohm
R Delta
15 RPM
o
RPM
0,936
30 RPM
o
RPM
1,133
40 RPM
o
RPM
1,301
1000 Ohm
30 RPM
1,0 Ohm
1000 Ohm
40 RPM
R Delta
1,0 Ohm
R 8aseJihe.
B) ALARM
TESTI
SP02
Aft Limit
[J
MEDKAl-
1000 Ohm
NABIZ
(%)
UstLimit
Aft Limit
(BPM)
Ust Limit
[J
KiM Muh., Dan., ic; ve DI~ TiC;. ltd.
Sayfa 3/6
Oll,um
Raporu
/ Measurement
Report
DR-12/04l3368
Marka:
Ill·
EKG
Testi
I ECG
A) Performans
NIHON
KOHDEN
Model;
Testil
Performance
Seri
K
No:
14057
Test
30 BPM
30 BPM
o 8PM
60 BPM
60 BPM
o BPM
1,133
80 BPM
80 BPM
NSRYeli~in
(QRSge:nHgiSDms)
IAdult
ms)
o BPM
1,301
1008PM
o BPM
1,488
120 BPM
120 BPM
a 8PM
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
30 BPM
o BPM
0,936
60 BPM
o BPM
1,133
60 BPM
_,Padi,""c
0,936
100 BPM
30 BPM
NSRPedi,,",
e=i~A:&
l5,k.,1h;;;.
Vat""
(QRSwidth80
BSM-2301
Test
80 BPM
80 BPM
o BPM
100 BPM
100 BPM
a BPM
1,488
120 BPM
120 BPM
o BPM
1,687
180 BPM
180 BPM
o BPM
2,325
220
220
o BPM
2,769
BPM
BPM
1,301
240 BPM
240
BPM
o BPM
2,994
300
300
BPM
o BPM
3,677
BPM
ve
D) ST Yukselmesi
ST Elevation
and
Cokmesi
Depression
Testi
Wave
M6dIMOde:
I
Test
$~t1iJ91REl$~lt
10 Hz
0,8
mV
o
2 H,
0,5
mV
o
Hz
0,5
0,125
0,8
2,0 Hz
o
o
mV
2,5 Hz
E) Arrythmia:
1,0 mV
B) Arrythmia;
Atrial
Testi
I Atrial
Ventricular
lViod. IlVIod$
2,0 mV
Testi
I Ventricular
Test
$onu9:IR~s~lt
o
Test
o
o
o
o
C Ya:i!:lclTesti
12,5 mm/s
25 mm/s
(30BPM)
(60BPM)
YaZICf Hit)
50 mm/s
100
MEDKAL·
KiM Muh"
Dan.,
it,;
mm/s
(120BPM)
(240BPM)
ve DIS Tic.
Ltd.
0
0
0
Cd
Ol~um Raporu I Measurement Report
DR·12/04l3368
Model:
Marka: NIHON KOHDEN
BSM-2301 K
SeriNo:
14057
IV - NIBP Testi I NJBP Test
A) Performans Testi / Performance Test
.;., ,.'""
l\l.diM~••
D,•• ,.,
33 mmHg
-3 mmHg
80 mmHg
79 mmHg
1 mmHg
63 mmHg
60 mmHg
65 mmHg
-2 mmHg
20:J mmHg
202 mmHg
-2 mmHg
166 mmHg
254 mmHg
215
195 mmHg
mmHg
196 mmHg
2,137
C) Man~et Basln~ AzaIma Hizi Testi I Cuff Pressure Decrease Rate Test
ModI Mode
Hava Sizma Oram I Air leak
5,00 mmHg
Rate
D) Alarm Test
05T LiMiT
MEDKAL· KIM Muh" Dan., il; ve 01' Til;, Ltd.
1,261
1 mmHg
Mod (Mode:
292 mmHg
1,497
o mmHg
216 mmHg
B) CUT-OFF TESTI
CUT-DFFTEST
1,065
-1 mmHg
151 mmHg
255 mmHg
1,261
-1 mmHg
102 mmHg
166 mmHg
0,998
-1 mmHg
117 mmHg
100 mmHg
150 mmHg
1,137
-1 mmHg
-2 mmHg
151 mmHg
116 mmHg
1,055
0,944
-1 mmHg
94 mmHg
82 mmHg
150 mmHg
0,917
-1 mmHg
2 mmHg
121 mmHg
93 mmHg
80 mmHg
0,989
-3 mmHg
77 mmHg
63 mmHg
120 mmHg
0,881
1 mmHg
99 mmHg
76 mmHg
~~~~:~
0,941
-2 mmHg
52 mmHg
100 mmHg
~~~"
-1 mmHg
30 mmHg
50 mmHg
ALTLiMiT
I>!
-.2 mmHg
41 mmHg
40 mmHg
Y~ti~kih DegerJerU
Adult PrBSets
(80I3PM)
(2~00ittmHg pPJ
,,,,,.,,
62 mmHg
60 mmHg
1,758
-1 mmHg
-1 mmHg
1,468
Oh;lim
Raporu
I Measurement
Report
DR-12/04l3368
Marka:
v . Slcakhk
NIHON
Testi I Temperature
KOHDEN
Model:
BSM-2301
K
Seri No:
14057
Test
T1 Clku}11 T1 Output
MEDKAl-
KiM Miih"
Dan.,
30,0 'C
30,0 'C
0,0 'C
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
il; ve
Dl~ Tic. ltd.
0,311
Sayfa 6/6