Product Name：Multi-parameter detector
Product model：KLM-A
Specification： ①.Suttlet weight：150Kg
②.Dimension（Host）：Bout 100cm length×72cm width×250cm heigh
③.Host Input Voltage：AC100V-240V 50Hz/60Hz 1.0A
Product Main Structural Composition：
It consists of height module, weight module, blood pressure module, forehead temperature module, blood oxygen probe, electrode (handle electrode and foot electrode) integrated circuit, base support, power line and mobile main body.
Intended purpose：
The multi-parameter detector is used to measure the blood pressure (systolic pressure, diastolic pressure, and pulse rate), forehead temperature, and blood oxygen (pulse oxygen saturation) for adult (Weight more than 30Kg, height more than 140cm) in the clinic.
This product is certified as a medical device in the European Union under the Medical Device Regulation (EU) 2017/745 by SGS CE1639, exclusively for the indication(s) of “measurement of blood pressure, forehead temperature, blood oxygen”. Other medical/non-medical uses ascribed to this device are not within the scope of CE certification, and users should be aware product performance and/or safety has not been evaluated by SGS for those purposes。
Product technical parameters：
|
Product Name |
Multi-parameter detector |
|
Model |
KLM-A |
|
Display Mode |
12.1inch touch LCD |
|
Blood pressure Measuring function |
|
|
Measurement methods |
oscillography measure |
|
Measuring range |
Pressure: 0kPa～40kPa(0mmHg～ 300mmHg) Pulse rate: 40 times/min～199 times/min |
|
Accuracy rating |
pressure：±0.4kPa(±3mmHg) Pulse rate：±5% |
|
Arm circumferences |
about 22cm～36cm |
|
Cuff pressure |
0～300mmHg |
|
Clinical performance |
Blood pressure Measuring function was clinically investigated according to the requirements of EN ISO 81060-2:2019. |
|
Forehead temperature Measuring function |
|
|
Rated output range |
22.0℃～42.9℃（71.6℉～109.2℉） |
|
Laboratory accuracy |
22℃～42.9℃ ±0.3℃ |
|
Display Resolution |
0.1℃ (0.1℉) |
|
Measuring Site |
Forehead |
|
Reference Body Site |
Armpit |
|
Body mode |
Adjusted mode |
|
Clinical accuracy |
Clinical bias，Δcb=-0.02 |
|
LIMITS OF AGREEMENT, LA=0.18 |
|
|
CLINICAL REPEATABILITY, σr,=0.07 |
|
|
Blood oxygen measuring function |
|
|
Measuring range |
70%～100% |
|
Blood oxygen saturation measuring accuracy |
±2% |
|
Height measuring function |
|
|
Measuring range |
80cm～205cm |
|
Measuring accuracy |
±1cm |
|
Weight measuring function |
|
|
Weighing range |
5kg～300kg |
|
Maximum permissible error of weighing |
5 kg≤m≤50kg ±0.3 kg |
|
50 kg＜m≤100 kg ±0.4 kg |
|
|
100 kg＜m≤200 kg ±0.8 kg |
|
|
200 kg＜m≤300 kg ±1.0 kg |
|
|
Body impedance |
|
|
Impedance measurement range |
200Ω～800Ω |
|
Accuracy |
±10% |
|
Function |
|
|
a) |
Total moisture |
|
b) |
Protein |
|
c) |
Bone weight |
|
d) |
Fat weight |
|
e) |
Standard body weight |
|
f) |
Body mass index |
|
g) |
Percentage of body fat; |
|
h) |
waist-to-hip ratio |
|
i) |
skeletal muscle |
|
j) |
Visceral fat index |
|
k) |
Blood pressure |
|
l) |
Height value |
|
m) |
Physical age |
|
n) |
blood oxygen level |
|
o) |
body temperature |
|
p) |
basal metabolism |
|
q) |
voice broadcast |
|
Power Supply |
100V-240V～ 50Hz/60Hz 1A |
|
Rated power |
230VA |
|
Normal working conditions |
Ambient temperature：5℃～40℃ Relative humidity：15 % ～90% RH Atmospheric pressure ：700hPa～ 1060hPa |
|
Transport and storage conditions |
Ambient temperature：- 20℃ ～50℃ Relative humidity：15% - 90% RH Atmospheric pressure ：500hPa～ 1060hPa |
|
Dimension（Host） |
Bout 100cm length×72cm width×250cm heigh |
|
Protection against electric shock |
classⅡequipment, BF type applied part |
|
Liquid intake protection classification |
IPX2 |
|
Disinfection and sterilization method |
Clean as recommended by the manufacturer |
|
Safety classification |
Equipment not to be used in the presence of flammable anesthetic gas mixed with air or with oxygen or nitrous oxide |
|
Fuse |
T2AH250V～ |
|
Running Mode |
continuous duty |
|
EMC |
1 group of class B devices |
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