Market KS-C01 Bikes Accessories Stand Instructions

KS-C01 Bikes Accessories Stand

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Specifications:

• Product: SpO2 Probe

• Model Options:

  • KS-C01 – Adult Finger Clip SpO2 Probe
  • KS-CM01 – Adult Finger Clip Smart SpO2 Probe
  • KS-YW02 – Universal Y-type with Rubber Wrap SpO2 Probe
  • KS-R01 – Adult Finger Rubber SpO2 Probe
  • KS-R02 – Pediatric Finger Rubber SpO2 Probe

• Intended Use: Monitoring SpO2 and pulse rate for adult and
  pediatric patients

• Composition: Light emitting diodes, photo-detector, plastic or
  rubber fixing mechanics, cable, connector

• Latex Free

Product Usage Instructions:

1. Connection: Connect the SpO2 probe to the
   panel connector marked with SpO2 label on the signal input of the
   patient monitor or oximeter. When unplugging, hold the head of the
   connector and pull it out.

2. Adult Finger Clip SpO2 Probe: Insert one
   finger (index finger preferred) into the probe according to the
   mark on the probe clip.

3. Adult Finger Rubber SpO2 Probe: Insert one
   finger (index finger preferred) into the probe according to the
   mark on the probe cap. Ensure the finger is inserted deeply enough
   for proper light transmission.

Warnings and Attentions:

• The SpO2 probe should be used with a compatible unit to avoid
  inaccurate measurements.

• Avoid using on active patients or for prolonged periods.

• Avoid exposure to direct sunlight to prevent overheating.

• Store and use within specified temperature, humidity, and
  pressure range for accurate results.

• Avoid use on patients with known allergies or anaphylaxis.

Compliance:

The product complies with industry standards and regulations for
medical devices.

FAQs:

Q: Can the SpO2 probe be used on pediatric patients?

A: Yes, the SpO2 probe can be used for monitoring SpO2 and pulse
rate for both adult and pediatric patients.

Q: How should I properly insert my finger into the probe?

A: Follow the marks on the probe clip or cap for proper
insertion. For adult finger clip probes, insert the index finger.
For rubber probes, ensure the finger is inserted deeply enough for
light transmission.

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SpO2 Probe

Directions for Use 3502-2290067 V1.6

Latex Free

Intended Use

It’s applicable to be used with a compatible patient monitor or a pulse oximeter device. The probe is intended to be used for non-invasively monitoring the functional arterial oxygen saturation (SpO2) and pulse rate (PR) for adult and pediatric patients.
Contraindications

This probe is contraindicated for use on active patients or for prolonged use.
Structure and Composition

It consists of light emitting diodes, photo-detector, plastic or rubber fixing mechanics, cable and connector. Please note that model KS-CM01 also contains the built-in electronic circuit for measurement. Model and Configuration see the table below.

No.

Model

Probe Name

Built-in measuring module

1

KS-C01

Adult Finger Clip SpO2 Probe

No

2

KS-CM01

Adult Finger Clip Smart SpO2 Probe

Yes

3

KS-YW02

Universal Y-type with Rubber Wrap SpO2 Probe

No

4

KS-R01

Adult Finger Rubber SpO2 Probe

No

5

KS-R02

Pediatric Finger Rubber SpO2 Probe

No

Note: Pediatric Finger Rubber SpO2 Probe is for pediatric weighting between 15kg – 40kg (or finger thickness between 8mm – 16mm)

Instructions for Use

SpO2 probe is a kind of very delicate part. Please follow the given steps and procedures while using it. Failure to operate correctly can cause damage to the SpO2 probe.
1. Connect the SpO2 probe to the panel connector marked with “SpO2” label on the signal input of the patient monitor or oximeter. When unplugging the probe, be sure to hold the head of the connector and pull it out.

2. For Adult Finger Clip SpO2 Probe, insert one finger (index finger is preferred, but middle or ring finger with proper nail length is possible as well) into the probe according to the mark on the probe clip, as shown in Figure 1.

Figure 1 Finger Clip Probe

Figure 2 Finger Rubber Probe

3. For Adult Finger Rubber SpO2 Probe, insert one finger (index finger is preferred, but middle or ring finger with proper nail length is possible as well) into the probe according to the mark on the probe cap, as shown in Figure 2. Note that the finger should be inserted deeply enough so that the light emitted from the opto-probe (at one side of Y-type probe) will transmit through the finger bone for light scattering before reaching to the receiving part of the Y-type probe.

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Figure 3 Universal Y-type Probe

Figure 4(A/B) Y-type Probe on Finger/on Sole

4. For Universal Y-type with Rubber Wrap SpO2 Probe, it can be wrapped onto finger or sole (especially for infant). This probe is shown in Figure 2 with open status, the rubber wrapper can be removed from the Y-type probe for cleaning, the wrapper fixation can be adjusted for probe alignment and proper tightness. Place the Y-type probe into its seating position within the wrapper and open the wrapper belt before wrapping onto finger or sole. When used on finger, put the finger inside the wrapper so as it is between the two sides of Y-type probe, then wrap the wrapper belt around the probe as illustrated in Figure 4(A). When used on sole, place the sole within the wrapper and wrap it up around the sole, then tighten the rubber belt with proper force as illustrated in Figure 4(B), it is strongly recommended to use self-adhesive gauze to fix the probe cable nearby the measuring site, so that the relative moving between the probe and the part to be measured could be avoided to increase signal quality. Note:1) The probe placement is critical for the signal strength and quality especially for measurement on sole. Try to make the light aiming for the opto-emitting and receiving parts (Y-type probe) each other in the opposite side, so that the light beam is as vertically transmitted as possible and the light path is as short as possible. 2) Make sure there is arterial blood capillary (with artery pulse) and bone (for light scattering) within the light path between the opto-emitting and receiving parts, so that the measurement will be effective. 3) The rubber wrapper should be adjusted for adequate force with not too tight and not too loose. Too tight force (the skin color will become pale after a while) will be uncomfortable or even cause injury to the patient, too loose force will induce more motion artifact to degrade the signal quality.

Warnings and Attentions:
The SpO2 probe should be used together with the compatible unit (such as a Patient Monitor and a Pulse Oximeter), otherwise, inaccurate measurement results will be caused. Although biocompatibility tests have been performed on all the applied parts, some exceptional allergic patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis.
All the parts of the probe should NOT be replaced at will. If necessary, please use the components provided by the manufacturer or those that are of the same model and standards as the accessories along with the monitor which are provided by the same factory, otherwise, negative effects concerning safety and biocompatibility etc. may be caused. Local laws and regulations must be followed when disposing of the SpO2 probe. A functional tester cannot be used to assess the accuracy of the SpO2 probe. Please do not use nail polisher or other cosmetic product on the nail. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy. Refer to the Monitor’s/Oximeter’s User Manual for additional warnings and attentions.
Operating Environment
1. Ambient temperature range: 5°C – 40°C; Relative humidity: 15% – 95%; Atmospheric pressure: 70kPa – 106.0kPa;
Operate method: the compatible unit supplies power for the probe.
2. The probe should be situated in a place protected against direct sunlight, so as to prevent overheating inside it. 3. The probe should be stored and used within specified temperature, humidity and atmospheric pressure range, or it
may cause damage to the probe or inaccurate measurement result.
Compliance
When used with the compatible Oximeters or Patient Monitors with compatible SpO2 module, the device conforms to
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IEC 60601-1. The electric safety classification: Type BF applied parts.
Accuracy Specifications
SpO2: 1. Transducer: dual-wavelength LED
Wavelength: Red light: 663 nm, Infrared light: 890 nm
Maximal optical output power: less than 2mW maximum average
2. SpO2 measuring range: 35%~100%
3. SpO2 measuring accuracy: Arms value (defined in ISO 9919) is not greater than 3% for SpO2 range from 70% to 100%.
Pulse Rate: 1. Measuring range: 30bpm – 240bpm
2. Accuracy: ±2bpm or ±2%, whichever is greater.
Classification
The type of protection against electric shock: Evaluate with the compatible main unit; The degree of protection against electric shock: At least with Type BF applied parts when used with the main unit. All specifications validated with the series product of Creative Pulse Oximeter (such as PC-68 series) and Patient Monitor (such as UP-8000, UP-6000 etc.) with Creative SpO2 module.
Troubleshooting
1. If no measurement readings, please check if the light emitting component within the SpO2 probe flashes (do not stare at the light from the probe), and check if the SpO2 probe cable is properly connected to the right connector on the signal input panel of the oximeter. If the problem still exists, please contact the manufacturer.
Maintenance
To make sure the normal working and prolong the using life of the SpO2 probe, please pay attention to maintain it. In case any indication of damage about the SpO2 probe is detected and proven, it is not allowed to use any more. Please contact the local dealer or the manufacturer for help. Routine Maintenance At each routinely maintenance or the yearly maintenance, the SpO2 probe together with the main unit can be thoroughly inspected by qualified personnel, including performance and safety examinations. If the hospital fails to carry out a satisfactory maintenance program about the main unit (oximeter or patient
monitor), it may damage the SpO2 probe and harm the patient’s safety and health. If there is any indication of cable and transducer damage or they deteriorate, they are prohibited from any
further use. The SpO2 simulator can not be used to verify the SpO2 measuring accuracy, which should be supported by the
clinical study conducted by inducing hypoxia on healthy, non-smoking, light- to-dark-skinned subjects in an independent research laboratory. However it is necessary for the user to use SpO2 simulator for routine verification of precision. Please note that the specific calibration curve (so called R-curve) should be selected when use of SpO2 simulator, e.g. for Index 2 series SpO2 simulator from Fluke Biomecidal Corporation, please set “Make” to “DownLoadMake: KRK”, then the user can use this particular R-curve to test the SpO2 function. If the SpO2 simulator does not contain “KRK” R-curve, please ask the manufacturer for helping to download the given R-curve into the SpO2 simulator.
Cleaning and Disinfection of the Probe
It is recommended to clean the measuring accessories (including probe/probe, wrapper and cable) with 75% Alcohol or 70% Isopropanol (Isopropyl) before use. Do not use damaged accessories. Do not immerse in fluid of any kind. Do not attempt any other type of disinfection other than that indicated.
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Storage

For maximum probe life and optimum performance, store the probe at room in a dry, dust-free, non-corrosive gas environment. Storage environment: Ambient temperature: -20 – 60°CRelative humidity: 10% – 95%Atmospheric pressure: 53kPa – 106kPa
Transportation

The probe can be transported via road rail or air in accordance with the manufactures guidelines. Do not drop or throw the probe in its packaging.
Symbols and Descriptions

Symbol

Description

Symbol Description

Symbol Description

Attention-refer to the manual

Manufacturer

Manufacturing date

Authorized representative in the European Community
This mark means that this device is fully in conformance with the Council Directive Concerning Medical Devices 93/42/EEC.

Serial Number
UK responsible person

Follow WEEE regulations for disposal
BF type applied part

Manufacturer: Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China Tel: +86-755-2643 3514 Fax: +86-755-2643 2832 E-mail: market@creative-sz.com
EC-Representative: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg, Germany

Etheria Medical Ltd

The Old Brush Factory Unit 2d Whickham Industrial Estate,

Swalwell, Newcastle Upon Tyne, United Kingdom, NE16 3DA

Tel: +44-191-4889922

Fax: +44-191-4889922

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