Creative Medical SP-20, Instructions To User

Page 1: ...ted into another language without the prior written consent We reserve the right to revise and amend it at any time without prior notice Version of the Manual Ver 1 0 Issued Date December 20th 2016 All rights reserved Notes The contents contained in this manual are subject to change without prior notice Information furnished by Creative is believed to be accurate and reliable However no responsibi...

Page 2: ...O NOT use the oximeter while the Patient is under MRI or CT scanning This device is NOT MRI Compatible Warnings Discomfort or pain may occur if using the sensor of this device continuously on the same location for a long time especially for the patients with poor microcirculation It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours or less if any a...

Page 3: ...ration corrosive substances explosive materials high temperature and moisture If the Oximeter gets wet please stop operating it and do not resume operation until it is dry and checked for correct operation When it is carried from a cold environment to a warm and humid environment please do not use it immediately Allow at least 15 minutes for the Oximeter to reach ambient temperature DO NOT operate...

Page 4: ...ntion to the effects of lint dust light including sunlight etc Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 2005 A1 2012 IEC60601 1 2 2014 IEC60601 1 11 2010 ISO 80601 2 61 2011 and follows the provisions of the council directive MDD93 42 EEC Caution U S federal law restricts this device to sale or use by or on the or...

Page 5: ...ment 7 3 1 SpO2 Measurement 7 3 2 Temperature Measurement optional 9 4 Operation 11 4 1 Power on off the Oximeter 11 4 2 Default Display Screen 11 4 3 Menu 14 4 4 Record 27 5 Technical Specifications 32 6 Over limit Indication 34 6 1 Limit settings 34 6 2 Over limit indication sound mute setting 34 7 Packing List 35 8 Repair and Maintenance 36 8 1 Maintenance 36 8 2 Cleaning and Disinfecting Instr...

Page 6: ...Manual for Handheld Pulse Oximeter 1 1 Overview 1 1 Appearance Power Left Mute Right Display screen Figure 1 1 Front View Rotate lock Up Setting Down Alert indicator Menu Confirm Record Back Power indicator ...

Page 7: ...p sound On menu or sub menu screen short time press it to move the cursor right or adjust the parameter values Note when the device alert indication is on short time pressing will mute the alert sound the mute state will persist for about 90s After this mute period 90s then the alert sound will resume 4 Rotate lock Up On measuring screen longtime pressing to enable or disable the automatic screen ...

Page 8: ...r disconnected or the measured value exceeds the preset alert limit value then the alert indicator will keep orange flashing 9 Power saving mode indicator If the device is set as power saving mode then the indicator keeps on And on measuring screen the indicator flashes with the pulse beep 10 Icon SpO2 SpO2 Probe Connector 11 Icon TEMP Temperature Probe Connector 12 DC power input used for connect...

Page 9: ... Real time battery status display and low battery voltage indication Auto power off is available Audible and visual alert function is available Data uploading to PC for management Optional Power saving mode is available 1 5 Intended Use This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate functional oxygen saturation SpO2 and temperature optional It is applicable for...

Page 10: ...d Pulse Oximeter 5 2 Preparation 2 1 Charger Base Connection Put the device into the charger base properly and note the polarity markings as shown in figure 2 1 Figure 2 1 Charger base connection 充电底座连接 Oximeter Charger base ...

Page 11: ...ply is 100 240VAC with 50 60Hz 3 External power supply from the USB cable Use the USB cable with micro USB connector connect one end of the USB cable to the connector on the device marked with or to the USB connector on the charger base marked with and the other end to the USB power source with output capacity of 5V DC 1A Note When using the supplied charger base for power supply please do not til...

Page 12: ...he SpO2 probe indicates a successful connection 3 Insert one finger index finger is preferred the nail should be not too long into the clip of the probe according to the finger mark as shown in figure 3 1 4 The device will begin to take the measurement and the measured result will be displayed on the screen as shown in figure 4 2 Figure 3 1 demonstration for SpO2 probe Safety instructions for SpO2...

Page 13: ...le tissue Do NOT put the SpO2 probe and pressure cuff on the same limb otherwise the blood pressure measurement may affect the SpO2 measurement The device is calibrated to display functional oxygen saturation Do NOT allow the sensor cable to twist or bend Check the SpO2 sensor and cable before use Do NOT use a damaged SpO2 sensor When the temperature of the SpO2 sensor is abnormal do not use it fu...

Page 14: ...may cause damage to the probe The infrared temperature probe is as shown in figure 3 2 Please place the infrared temperature probe in a stable ambient temperature for 30 minutes before taking a measurement Operation procedure 1 Connect the infrared temperature probe to the connector on the upper side of device marked with TEMP 2 When the screen shows as the big display screen in figure 3 2 Small s...

Page 15: ...nfrared temperature probe will switch to standby state automatically if there is no operation for 1 minute If a further measurement is needed press the measuring key and repeat step 2 and step 3 Normal body temperature varies depending on the position area the measurement is taken from The following table shows the varying temperature ranges of the different body positions Temperature varying rang...

Page 16: ... Long pressing Power Left key for 1 2 seconds then the oximeter will be powered on The oximeter will do self test and then show the software version as shown in figure 4 1 refer to your oximeter for actual version Figure 4 1 4 2 Default Display Screen Press power key for 2 seconds to start up the Oximeter then the screen will display the default screen as shown in Figure 4 2 ...

Page 17: ...und appears simultaneously Alert sound is SpO2 mark SpO2 value Pulse Plethysmogram Current time SpO2 high low limit setting range Patient type Sound indicator Battery indicator Pulse rate mark and unit Pulse Strength bar graph Pulse symbol Pulse rate value Figure 4 2A Default Display Screen in vertical HR high low limit setting range User ID Measurement mode Auto power off disable icon Wireless ic...

Page 18: ...te lock icon turns to blue it means the auto rotation function is turned on if you place this oximeter horizontally then the display shows in horizontal as shown in figure 4 2B Sound indicator means the device is on mute status the user can turn on the indication sound by short pressing key Short time press key can turn off or resume the device sound including pulse beep sound audible alert and ke...

Page 19: ...rrent corresponding storing space is not full If the memory is full the data storing will continue in such way the new record will overwrite the oldest record so that it s recommended to upload the stored data into the computer in time 4 3 Menu On the default measuring screen short time press Menu Confirm key for entering into main menu screen as shown in Figure 4 3 There are 9 functional icons in...

Page 20: ... grey and the patient type on upper left corner turns to pink Measurement mode Select the measurement mode Spot check mode and Continuous mode for option SpO2 record Recall and review the records stored on the oximeter two method for option Spot check Record and Continuous Record see Section 4 4 for details Figure 4 3 Main menu ...

Page 21: ...mode etc see Section 4 3 7 for details Alert Set the low alert limit for SpO2 and the high low alert limit for HR see Section 4 3 8 for details Help To view the tips information of SpO2 measurement and temperature measurement see Section 4 3 9 for details 4 3 1 User ID On main menu screen move the cursor on User ID and press Confirm key then the oximeter enters into User ID Setup screen as shown i...

Page 22: ...can edit the User ID and move the cursor on OK to confirm the edit the edit screen is as shown in figure 4 4B Figure 4 4B User ID edit screen 4 3 2 User On main menu screen move the cursor on User and press Confirm key then the oximeter enters into Patient type Setup screen as shown in figure 4 5 Figure 4 5 Patient type setup screen ...

Page 23: ...rement Mode Setup screen as shown in figure 4 6 Figure 4 6 Measurement mode setup screen 4 3 4 SpO2 Record On main menu screen move the cursor on SpO2 Record and press Confirm key then the oximeter enters into SpO2 record review method selecting screen as shown in figure 4 7 Figure 4 7 SpO2 record review method selecting screen Refer to Section 4 3 for details 4 3 5 TEMP Record ...

Page 24: ...ord and press Confirm key then the oximeter enters into temperature record list screen as shown in figure 4 8 Figure 4 8 TEMP record list screen 4 3 6 Date On main menu screen move the cursor on Date and press Confirm key then the oximeter enters into date setup screen as shown in figure 4 9 ...

Page 25: ... key to confirm and exit from date setting 4 The procedures of adjusting Month Day Hour Minute and Second value are the same with Year adjustment Date Format DD YY MM Time Format HH MM SS Note The setting operations of other parameters such as User ID User Auto Power Off Power Saving etc are the same with date setting 4 3 7 Setting On main menu screen move the cursor on Setting and press Confirm k...

Page 26: ...n figure 4 10B Language This oximeter provides the display with two languages English and Simplified Chinese the factory default is English as shown in figure 4 10C Auto power off To turn on off the Auto Power Off mode the factory default is On as shown in figure 4 10D Wireless To turn on off the wireless connection function the factory default is On as shown in figure 4 10E Power saving mode To t...

Page 27: ...n figure 4 10H Version For viewing version number of the software as shown in figure 4 10I Demo Enter into the Demonstration mode as shown in figure 4 10J Figure 4 10A Brightness setup Figure 4 10B Volume setup Figure 4 10C Language setup Figure 4 10D Auto Power OFF setup Figure 4 10E Wireless setup Figure 4 10F Power Saving setup ...

Page 28: ...anual for Handheld Pulse Oximeter 23 Notes When the Auto Power Off is set to On option if there is no Figure 4 10G TEMP unit setup Figure 4 10I Version info Figure 4 10H Default setting Figure 4 10J Demo mode ...

Page 29: ...ove the cursor on Alert and press Confirm key then the oximeter enters into alert setting screen as shown in figure 4 11 Figure 4 11 Alert setting screen SpO2 Lo Limit SpO2 low limit setting range 50 99 the step is 1 The factory default value for adult is 90 and 95 for pediatric PR Hi Limit High limit setting of pulse rate range 100 240bpm From 100 to 150 the step is 1bpm and from 150 to 240 the s...

Page 30: ...t then the over limit alert event will be activated that s the alert sound bibibibi occurs and the corresponding reading s blinks When measured on pediatric if the SpO2 reading is lower than or equal to the preset alert setting for 10 seconds then the alert sound and blinking display will be activated 4 3 9 Help On main menu screen move the cursor on Help and press Confirm key then the oximeter he...

Page 31: ...User Manual for Handheld Pulse Oximeter 26 Figure 4 12 Help information SpO2 measurement ...

Page 32: ...r Handheld Pulse Oximeter 27 Figure 4 12 Help information TEMP measurement 4 4 Record 4 4 1 Data Recall On main default screen short time press Record Back key to enter into data recall screen as shown in figure 4 13 ...

Page 33: ...Record Spot check Record list shows the recording time SpO2 value and pulse rate value as shown in figure 4 14 Figure 4 14 Spot check Record list If Continuos Record is selected then the screen shows the Continuos Record list as shown in figure 4 15 press Up Down The corresponding User and User ID for the selected record ...

Page 34: ...rd you need to review Select one record you need to review and press Confirm key then the screen shows the corresponding User User ID and trend graph as shown in figure 4 16 Figure 4 15 Continuos record List The corresponding User and User ID for the selected record ...

Page 35: ...ist screen shown in figure 4 14 or 4 15 move the cursor on the record you want to delete and longtime pressing Mute Right key then an message Are you sure to delete all prompts on the screen as shown in figure 4 16 SpO2 trend graph PR trend graph The corresponding User and User ID for the selected record Recording time ...

Page 36: ... 4 4 3 Data Upload If you want to upload the stored data SpO2 PR and TEMP values to the computer then Make sure the provided USB data cable is well connected between the device and PC before uploading data as shown in figure 4 17 Refer to the instruction in Oximeter Data Manager User Manual for detailed operation Figure 417 Data uploading screen During data uploading the user can not do any operat...

Page 37: ... dual wavelength LED sensor with wavelength Red light 663 nm Infrared light 890 nm Maximal average optical output power 2mW Display range 35 100 Measuring accuracy Arms is not greater than 3 for SpO2 range from 70 to 100 NOTE Arms is defined as root mean square value of deviation according to ISO 80601 2 61 SpO2 low alert limit setting range 50 99 The device is calibrated to display functional oxy...

Page 38: ...06kPa Note portable and mobile RF communications equipment may affect the performance of the Oximeter I Low Perfusion Performance The accuracy of SpO2 and PR measurement still meet the precision described above when the modulation amplitude is as low as 0 5 J Resistance to interference of surrounding light The difference between the SpO2 value measured in the condition of indoor natural light and ...

Page 39: ...activated the value that is over limit will blink at the same time 6 2 Over limit indication sound mute setting During the measurement if the over limit indication sound is set to on short time press Mute Right key then the over limit indication sound will mute for 90 seconds but the over limited value still keeps blinking At this moment the speaker volume icon becomes If this alert event persists...

Page 40: ...ge See the package in your hand for detailed items and quantity 2 All the parts of the device should NOT be replaced at will If necessary please use the components provided by the manufacture or those that are of the same model and standards as the accessories along with the device which are provided by the same factory Otherwise negative effects concerning safety and biocompatibility etc may be c...

Page 41: ...ve humidity control and 70 at a relative humidity up to 93 non condensing The oximeter is calibrated in the factory before sale there is no need to calibrate it during its life cycle However if it is necessary to verify its accuracy routinely the user can do the verification by means of SpO2 simulator or it can be done by the local third party test house 8 2 Cleaning and Disinfecting Instruction S...

Page 42: ...be into the device Device will not switch on 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctioning 1 Recharge or change batteries 2 Reinstall batteries 3 Please contact the local service center No Display 1 The device will power off automatically when there is no signal and no operation for 1 minute 2 The batteries are almost drained...

Page 43: ...Do not shake the finger and keep calm during the measurement Please also avoid the oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously 6 Q How to confirm that the SpO2 reading is true or accurate A Hold breath for a while 50 seconds or more if the SpO2 value significantly decreases it means that the SpO2 reading truly reflects the physiologica...

Page 44: ...care d Excessive patient movement e Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line f Exposure to the chamber with High pressure oxygen g There is an arterial occlusion proximal to the sensor h Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing i Low perfusion condition Perfusion Index is small ...

Page 45: ...The oxygen saturation PI Perfusion Index bpm Pulse rate Unit beats per minute Pulse bar graph Low battery voltage Battery is full Speaker mute icon Speaker volume icon SpO2 spot check record memory full SpO2 continuous record memory full Temperature memory full Wireless transmission icon Pediatric Adult Patient type ...

Page 46: ...ure probe connector Power Left Key Mode Right Key Rotate lock Up Key Setting Down Key Menu Confirm key or Record Back key CE mark SN Serial number Date of manufacture Manufacturer including address With Type BF applied part See User Manual Disposal of this device according to WEEE regulations No alarm Do not litter at will ...

Page 47: ... directly proportional with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO2 and deoxygenated hemoglobin Hb have different absorption character in the spectru...

Page 48: ...greater than 94 so the values below 94 are determined as hypoxia SpO2 90 is considered as the default threshold for determining anoxia by most researchers so SpO2 low limit of the oximeter is set as 90 generally 4 Factors affecting SpO2 accuracy interference reason Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps bilirubin lam...

Page 49: ...athology reason Hypoxemia disease functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough ...

Page 50: ...ment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Oximeter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Oximeter suitable for use in all establishments including domestic establishments and those d...

Page 51: ...ment Immunity test IEC60601 test level Complianc e level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 6 kV contact 8kV air 6 kV contact 8kV air Floors should be wood concrete or ceramic tile if floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC61000 4 4 2kV for power Supply lines 1 kV for input...

Page 52: ...c field IEC61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Table 3 Guidance and manufacturer s declaration electromagnetic immunity The Oximeter is intended for use in the electromagnetic environment specified below The...

Page 53: ...ould be used no closer to any part of The Oximeter including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz to 800MHz d 2 3 P 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is th...

Page 54: ...n each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ...

Page 55: ...ary such as re orienting or relocating The Oximeter b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Table 4 Recommended separation distances between portable and mobile RF communication the equipment The Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of The Oximeter can h...

Page 56: ...ice pursuant to part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference wil...

Page 57: ...nterference and 2 this device must accept any interference received including interference that may cause undesired operation Any Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment RF Exposure The equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment ...

Page 58: ...User Manual for Handheld Pulse Oximeter 53 Quality Inspection Certificate ...