DCD of pulse oximeter
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Risk Management Process Device Characteristics Documentation Name of the device: Pulse Oximeter DCD Prepared by: YANAMALA VIJAYRAJ Date:10/8/2015 1 What is the intended use? An oximeter is a device used to transmit radiation at a known wavelength through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Intended to measure amount of oxygen saturated. 2 Is the medical device intended to be implanted? No 3 Is the medical device intended to be in contact with the patient or other persons? Yes (in contact with patients) 4 What materials or components are utilized in the medical device or are used with, or in contact with, the medical device? LED's are made of materials like gallium arsenide phosphide, gallium phosphide, gallium arsenide, gallium aluminum arsenide. 5 Is energy delivered to or extracted from the patient? No 6 Are substances delivered to or extracted from the patient? No 7 Are biological materials processed by the medical device for subsequent re- use, transfusion or transplantation? No 8 Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable? Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended for sterilization.
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Transcript of DCD of pulse oximeter
Risk Management Process Device Characteristics Documentation
Name of the device: Pulse Oximeter
DCD Prepared by: YANAMALA VIJAYRAJ Date:10/8/2015
1 What is the intended use? An oximeter is a device used to transmit radiation at a known wavelength through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation.
Intended to measure amount of oxygen saturated.
2 Is the medical device intended to be implanted?
No
3 Is the medical device intended to be in contact with the patient or other persons?
Yes (in contact with patients)
4 What materials or components are utilized in the medical device or are used with, or in contact with, the medical device?
LED's are made of materials like gallium arsenide phosphide, gallium phosphide, gallium arsenide, gallium aluminum arsenide.
5 Is energy delivered to or extracted from the patient?
No
6 Are substances delivered to or extracted from the patient?
No
7 Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation?
No
8 Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?
Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended for sterilization.
Risk Assessment – Discussion Session Device Characteristics Documentation
Page 2 of 4
9 Is the medical device intended to be routinely cleaned and disinfected by the user?
Yes, oximeter surface should be routinely cleaned and disinfected. Clean the inside of the elastic thimble and the two optical elements inside with a cotton swab or equivalent moistened with a mild detergent solution or medical alcohol (70% isopropyl alcohol solution)
10 Is the medical device intended to modify the patient environment?
Absolutely No
11 Are measurements taken? Yes
12 Is the medical device interpretative? Yes
13 Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?
The fingertip pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
14 Are there unwanted outputs of energy or substances?
No
15 Is the medical device susceptible to environmental influences?
Yes
Storage Environment
a)Temperature:-40℃～+60℃
b)Relativehumidity:5%～95%
c)Atmosphericpressure:500hPa～1060hPa
Operating Environment
a)Temperature:0℃～50℃
b)RelativeHumidity:15%～95%
c)Atmosphericpressure:700hPa～1060hPa
16 Does the medical device influence the environment?
No
Risk Assessment – Discussion Session Device Characteristics Documentation
Page 3 of 4
17 Ate there essential consumables or accessories associated with the medical device?
wrist Band, Power Adopter, Data line, PC software, oximeter probe
18 Is maintenance or calibration necessary?
Little maintenance needed
Calibration not needed since the value measured is ratio.
19 Does the medical device contain software?
Yes
20 Does the medical device have a restricted shelf-life?
3 years
21 Are there any delayed or long-term use effects?
No
22 To what mechanical forces will the medical device be subjected?
It is not subjected to any mechanical forces.
23 What determines the lifetime of the medical device?
Extreme moisture may affect oximeter lifetime and may cause damage.
24 Is the medical device intended for single use?
No
25 Is safe decommissioning or disposal of the medical device necessary?
No
26 Does installation or use of the medical device require special training or special skills?
Little training
27 How will information for safe use be provided?
By providing user friendly manuals or conducting workshop about it, information for safe use is provided.
28 Will new manufacturing processes need to be established or introduced?
No
Risk Assessment – Discussion Session Device Characteristics Documentation
Page 4 of 4
29 Is successful application of the medical device critically dependent on human factors such as the user interface?
No
30 Does the medical device use an alarm system?
Yes
31 In what way(s) might the medical device be deliberately misused?
i) unnecessary usage
ii) alarm meaning notified to relatives and patients to prevent unnecessary tensions
iii) Not to use it while CPR
iv) Proper size of probe
32 Does the medical device hold data critical to patient care?
Yes
33 Is the medical device intended to be mobile or portable?
Yes
Mobile or portable versions are also available in the market.
34 Does the use of the medical device depend on essential performance?
ISO 9919 Medical electrical equipment particular requirements for the basic safety and essential performance of pulse oximeter equipment for the medical use.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen hemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment.
