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Gima RS01 User Manual
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Gima RS01 User Manual

Gima RS01 User Manual

Sleep apnea screen meter
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PROFESSIONAL MEDICAL PRODUC TS
SLEEP APNEA SCREEN METER
RS01 (GIMA 33676)
CONTEC MEDICAL SYSTEMS CO., LTD
No 112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, 066004,
0123
PEOPLE'S REPUBLIC OF CHINA
Made in China
Prolinx GmbH Brehmstr. 56,
1060hPa
95%
55°C
40239 Duesseldorf Germany
%
500hPa
0%
-40°C
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
IP22
www.gimaitaly.com

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  • Page 1 PROFESSIONAL MEDICAL PRODUC TS SLEEP APNEA SCREEN METER RS01 (GIMA 33676) CONTEC MEDICAL SYSTEMS CO., LTD No 112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004, 0123 PEOPLE’S REPUBLIC OF CHINA Made in China Prolinx GmbH Brehmstr. 56, 1060hPa 55°C...
  • Page 2 User Notice Dear Users, thank you very much for purchasing the Sleep apnea screen meter. This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
  • Page 3 Owing to the forthcoming renovation, the specific products you received may not be totally in accordance with the description of this User Manual. We would sincerely regret for that. Our company has the final interpretation to this manual. The content of this manual is subject to change without prior notice.
  • Page 4 used on the same finger for more than 6 hours. For some special users who need a more careful inspection on the test site, please don’t place the device on the edema or tender tissue. Please do not stare at the red and infrared light emitter (the infrared light is invisible) after turning on the device, including the maintenance staff, as it may be harmful to the eyes.
  • Page 5 Do not reprocess the accompanying SpO probe. Check the device before use to make sure that there is no visible damage that may affect user’s safety and device performance. When there is obvious damage, please replace the damaged parts before use. When the message “Sensor Off”...
  • Page 6 Do not place the device in places exposed to direct sunlight, high temperature, humidity, dust, cotton wool or easy to splash water, to avoid affecting its performance. The measured accuracy will be affected by the interference of electrosurgical equipment. When several products are used on the same patient simultaneously, danger may occur which is arisen from the overlap of leakage current.
  • Page 7 Contents 1 Overview ........................... 1 1.1 Features ........................2 1.2 Applied range ....................... 2 1.3 Environment requirements ................... 2 1.4 Precautions ........................3 2 Principle ............................ 9 3 Functions ..........................10 4 Installation ..........................11 4.1 Appearance ........................ 11 4.2 Interface introduction....................12 4.3 Structure, accessories and software description ............
  • Page 8 6 Maintain, Transport and Storage ..................... 37 6.1 Cleaning and disinfection ..................37 6.2 Maintenance ....................... 38 6.3 Transport and Storage ....................38 7 Troubleshooting........................40 8 Symbols ........................... 42 9 Specification ..........................44 Appendix 1: EMC ........................48...
  • Page 9 1 Overview The oxygen saturation is the percentage of HbO in the total Hb in the blood, so-called the O concentration in the blood, it is an important physiological parameter for the respiratory and circulatory system. A number of diseases related to respiratory system may cause the decrease of SpO in the blood, furthermore, some other causes such as the malfunction of human body's self-adjustment, damages during surgery, and the injuries caused by some medical checkup...
  • Page 10 power-on to record or auto power-on in accordance with the sleep time estimated to record, to reduce patient’s psychological burden and test easily. After setting auto power-on, the device will save the cases automatically. Adopt a large capacity SD card to store many cases, upload case by USB to PC or computer for saving directly.
  • Page 11 b) Relative humidity: ≤ 95% c) Atmospheric pressure: 500 hPa ~ 1060 hPa Operating Environment a) Temperature: 10 ℃~ 40 ℃ b) Relative Humidity: ≤ 75% c) Atmospheric pressure: 700 hPa ~ 1060 hPa 1.4Precautions 1.4.1Attention Point out conditions or practices that may cause damage to the device or other properties.
  • Page 12 The device may not be suitable for all users, if you can't get a satisfactory result, please  stop using it. Data averaging and signal processing have a delay in the upgrade of SpO data values.  When the data update period is less than 30 seconds, the time for obtaining dynamic average values will increase, which is arisen from signal degradation, low perfusion or other interference, it depends on the PR value.
  • Page 13 When it tends to be smooth and stable, the measured value read is the optimal and the waveform at this time is also the most standard. The device can not be used during charging.  If necessary, please visit our official website to get the information about SpO probe ...
  • Page 14 The light between the photoelectric receiving tube and the light-emitting tube of the  device must pass through the subject’s arteriole. Make sure the optical path is free from any optical obstacles like rubberized fabric, to avoid inaccurate results. Excessive ambient light may affect the measured results, such as surgical light ...
  • Page 15 unplug, otherwise the power will not be cut off in time when necessary, causes damage. The actual product may be slightly different from the picture in the manual ,please refer  to the actual product. The service life of digital sleep monitor finger sleeve blood oxygen probe is two years. ...
  • Page 16 1.4.2Clinical restriction A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO waveform (PLETH) will decrease.
  • Page 17 2 Principle The product makes a preliminary judgment on whether the user has sleep apnea - hypopnea syndrome and the severity of the disease by recording and analyzing the changes of during a sleep. respiration and SpO...
  • Page 18 3 Functions A.It can collect the signals of nasal airflow,oxygen saturation and pulse in real time,and display the waveform and data in real time. B.Multi case storage function C.Card reading function D.Storage function of case database E.PC software case data and analysis results display function F.Report output function G.Continuous recording time H.Real-time clock...
  • Page 19 4 Installation 4.1Appearance The device is consisted of main unit, nasal oxygen cannula, SpO probe, power adapter （optional）, USB data line and PC software.No detachable parts for main unit itself, applied parts: the nasal oxygen cannula and SpO probe, they are detachable parts.
  • Page 20 4.2Interface introduction Figure4.1 Measurement interface...
  • Page 21 Figure 4.2 Record interface (1)SpO value display Sign: %SpO Description: it displays SpO value after inserting the finger into the SpO probe. (2)Pulse rate value display Sign: PRbpm Description: it displays PR value after inserting the finger into the SpO probe.
  • Page 22 Sign: Description: it displays the pulse beat after inserting the finger into the SpO probe. (4)Nasal airflow waveform Sign: flow Description: real-time display of nasal airflow waveform (5)SpO plethysmogram waveform display Sign: SpO Description: real-time display of PLETH waveform (6)Pulse sound indication Sign: Description: : ON,...
  • Page 23 Description: it indicates low battery when flickers. (9)Real-time clock display Sign: 08:55 Description: it displays real-time clock (10)Lower limit of SpO prompt Sign: 85 Description: the current lower limit value is “85”. (11)Record indication Sign: REC Description: flickers under record state (12)Recorded time display Sign: 00:00:01 Description: the time that the device has recorded, format: hour:minute:second...
  • Page 24 4.3Structure, accessories and software description A. Main unit,nasal oxygen cannula,SpO probe,power adapter (optional),USB data line,PC software B.Accessories:Two Luer male adapter,One User Manual Please check the device and accessories according to the list to avoid that the device can not work normally. C.Software description PC software name: ResMon PC software model: No...
  • Page 25 5 Operating 5.1 Operation and use of the instrument 5.1.1 Button operation ON / OFF / Awake button Power on: the green indicator is light after long pressing “ ”, then it enters to the measurement interface after displaying the time. Power off: under non-record state, long pressing “...
  • Page 26 Figure 5.1 Figure 5.1 Main menu Table 5.1 Function Description Prompt Select it to enter its setting menu System Setup Select it to enter its setting menu Schedule Poweron Select it to enter its setting menu Record Select it to enter its setting menu DEMO Select it to enter DEMO interface Clock...
  • Page 27 2.Prompt setting The prompt setting menu is shown as Figure 5.2 Figure 5.2 Prompt setting menu When the “prompt” is “ON”, the device will give a sound prompt when over-limit or low battery appears. When “Pulse Sound” is “ON”, it can give a pulse sound prompt. Table5.2 Function Description...
  • Page 28 Prompt Sound “ON” / “OFF”, default: “OFF” Pulse Sound “ON” / “OFF”, default: “OFF” Exit Select it to return to previous menu. 3.System menu The system menu is shown as Figure 5.3: Figure 5.3System menu Table 5.3 Function Description Hard.ver Hardware version number, which can not be set by user.
  • Page 29 Language setup Select it to enter language setting interface Delete Data Delete data stored by the device Exit Select it to return to previous menu. The language setting menu is shown as Figure 5.4 Figure 5.4 Language setting menu Table5.4 Function Description English...
  • Page 30 4.Auto Record Auto Record setting menu is shown as Figure 5.5: Figure 5.5Auto Record menu Table 5.5 Function Description Set Month Setting range: 1 ~ 12 Set Day Setting range: 1 ~ 31 Set Hour Setting range: 0 ~ 23 Set Minute Setting range: 0 ~ 59 Record...
  • Page 31 Auto Record? “NO”/“YES”, YES: confirm, No: cancel Select it to return to previous menu, “YES”: exit this interface, the Exit settings take effect. Attention: “Auto poweron” can not be set during recording. Attention: when it reaches the set time and under “OFF” state, the device will turn on and record automatically.
  • Page 32 Figure 5.6 Record setting menu Figure 5.7 Recorded time interface...
  • Page 33 Attention: If the interface prompts “TF card is full” during recording, it indicates that the remaining capacity of the built-in SD card is insufficient, then the user can not record, the user need to transfer previous cases via computer. Manual poweroff can not be performed during recording, please exit the record mode firstly, then power off.
  • Page 34 Figure5.8Stop recording menu 6．Time setting The time setting menu is shown as Figure 5.9: Figure 5.9Time setup menu...
  • Page 35 Table 5.6 Function Description Set Year Setting range: 10 ~ 99, represents 2010 ~ 2099 Set Month Setting range: 1 ~ 12 Set Day Setting range: 1 ~ 31 Set Hour Setting range: 0 ~ 23 Set Minute Setting range: 0 ~ 59 Are you “No”...
  • Page 36 check the respiration state after stable waveform appears. Wearing mode of nasal oxygen cannula is shown as Figure 5.11, and the overall wearing mode is shown as Figure 5.12. Figure 5.10Connection of nasal oxygen cannula...
  • Page 37 Figure 5.11 Wearing mode of nasal oxygen cannula...
  • Page 38 Figure 5.12Sketch map of overall wearing Attention: Wear the nasal oxygen cannula according to the regulations, or it will affect the  collection effect. If the non-screwing nasal oxygen cannula is used, then use the Luer male plug to  connect.
  • Page 39 2.Monitoring of SpO and PR The device equips with the two SpO probes as table 5.7 Table 5.7 Whether Name Quantity Length (cm) shielding Digital fingerstall SpO probe Disposable non-woven adult probe Figure 5.13 Digital fingerstall SpO probe Figure 5.14Disposable non-woven adult probe...
  • Page 40 Figure5.15Wearing mode of probe Insert the SpO probe into USB interface, the wearing way is shown in Figure5.15. (1) Connect the probe with the device. (2) Insert the finger into the probe. (3) Under the measurement interface, read the related data directly from the LCD. Attention: When inserting the finger, the light emitting from the sensor must be directly irradiated to the side of the fingernail.
  • Page 41 5.1.5Automatic sync clock and USB data upload Long press “ ” to turn on the device to enter to the main interface, insert one end of the USB data line into USB interface as Figure5.16, the other end to the USB interface of PC as Figure 5.17, the connection mode from the device to PC is shown as Figure5.18.
  • Page 42 Figure 5.16Sketch map for connection between Sleep apnea screen meter and USB data line Figure5.17 Sketch map for connection between PC and USB data line...
  • Page 43 Figure 5.18 Sketch map for connection between device and computer 1. USB data line 2. Sleep apnea screen meter 3. PC Attention: The data can not be uploaded until stop recording.  If “Device drive letter” can not be recognized, unplug the USB data line and insert it ...
  • Page 44 5.1.6Delete data Figure 5.19 Delete date interface As shown in the figure,when the data stored in the device needs to be deleted,the system settings interface in the menu is entered.Select the “Delete Data” option,When the “delete all data?”Select “Yes”.The date in the device is then completely delete. 5.1.7Charging Connect one end of the power adapter to power socket, the other end to the device by the data line.
  • Page 45 Attention: To ensure enough operation time, please fully charge the battery before measuring.  Please charge the device under “OFF” state.  6 Maintain, Transport and Storage 6.1 Cleaning and disinfection Do not immerse it into liquid.Use 75% alcohol to wipe the device enclosure and the nail pad, and use liquid soap or isopropanol to wipe the watchband for disinfection nature dry or clean it with clean and soft cloth.
  • Page 46  Do not leave any cleaning solution on the surface of the device. 6.2 Maintenance A.This device is a sophisticated electronic device, please handle with care. Maintain this device according to the measures listed below, which will prolong this device life. B.Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient’s safety and monitoring performance.
  • Page 47 contract. During transportation, avoid strong shock, vibration and splashing with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive material. B.B.The packed device should be stored in room with no corrosive gases and good ventilation. Temperature: -40°C~+55°C;...
  • Page 48 7 Troubleshooting Trouble Possible Reason Solution 1.The finger is not properly inserted. 1.Please insert the finger properly The values can 2.The finger is shaking or the and measure again. not be displayed patient is moving. 2.Let the patient keep calm. normally or 3.The device is not used in 3.Please use the device in normal...
  • Page 49 The device can 1.Low battery or the battery is 1.Please charge the battery. not be turned drained away. 2.Please contact the after-sales. 2.The device works abnormally. 1.The device enters into the energy The display 1.Normal. saving mode. disappears 2.Please charge the battery. 2.Low battery.
  • Page 50 8 Symbols Your device may not contain all the following symbols. Symbo Meanings Meanings Symbol Oxygen saturation (unit: %) Pulse rate (unit: bpm) %SpO PRbpm Sound prompt: OFF Fully charged Sound prompt: ON Two grid of power Pulse sound: OFF One grid of power Pulse sound: ON Low battery...
  • Page 51 Covering Protection rate WEEE disposal IP22/IPX1 Date of manufacture Material code Product code Sterilized using ethylene oxide Lot number. Not made with natural rubber Authorized representative in latex the European Community Disposable device, do not re-use Class II applied For indoor use only Follow instructions for use Temperature limit Humidity limit...
  • Page 52 Finger Sensor The probe is disconnected. The finger is not inserted. Sensor Probe failure Medical device Fault Imported by Medical Device compliant with Directive 93/42/EEC 9 Specification [see note 1] Display range 0% ~ 99% Measured range 0% ~ 100% Accuracy [see 70%~100%: ±2%;...
  • Page 53 Display range 30 bpm ~ 250 bpm Measured range 30 bpm ~ 250 bpm Accuracy[see ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during note3] the pulse rate range of 100 bpm ~ 250 bpm. Resolution 1 bpm Nasal airflow...
  • Page 54 function then 12 hours. Safety class Internally powered equipment, type BF applied part International IP22. Protection Working voltage DC3.6 V—4.2 V Working current ≤100 mA A rechargeable lithium battery (3.7V) .The red wire on the battery denotes Power supply anode, the black wire on the battery denotes cathode. Battery life Charge and discharge: no less than 500 times.
  • Page 55 safety of application in the presence of flammable gas The mode of continuous operation operation Display color LCD Note 1: the claims of SpO accuracy shall be supported by clinical study measurements taken over the full range. By artificial inducing, get the stable oxygen level to the range of 70 % to 100 % SpO , compare the SpO values collected by the secondary standard pulse oximeter...
  • Page 56 RMS to indicate the accuracy of the PR. Note 4: optical sensors as the light-emitting components, will affect other medical devices applied the wavelength range. The information may be useful for the clinicians who carry out the optical treatment.For example, photodynamic therapy operated by clinician. Appendix 1: EMC This equipmen is suitable for professional healthcare facility environments and home healthcare environments...
  • Page 57 decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM. Including but not limited to power cord.  Devices or systems should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, it should be observed to verify normal operation in the configuration in which it will be used.
  • Page 58  When the device is disturbed, the data measured may fluctuate, please measure repeatedly or in another environment to ensure its accuracy.  Other devices may affect this device even though they meet the requirements of CISPR. Product configuration Serial number name Cable length SpO2 probe...
  • Page 59 Voltage fluctuations Complies and flicker IEC 61000-3-3 Table 2 Guidance and Declaration - Electromagnetic Immunity IEC 60601 Immunity Test Compliance level Test level Electrostatic ±8 kV contact ±8 kV contact discharge (ESD) ±15 kV air ±15 kV air IEC 61000-4-2 Electrical fast ±2 kV for power transient/burst...
  • Page 60 0 % UT; 1 cycle and 0 % UT; 1 cycle and 70 % UT ; 25/30 70 % UT ; 25/30 cycles ;Single phase:at 0°. cycles ;Single phase:at 0°. 0 % UT ; 250/300 0 % UT ; 250/300 cycle cycle Power frequency...
  • Page 61 NOTE UT is the a.c.mains voltage prior to application of the test level Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity Test IEC60601- Complianc Frequen Band Service Modulation e level (MHz) Test level (V/m) Radiated RF (MHz) (V/m) IEC61000-4-3 Pulse (Test Modulation...
  • Page 62 217 Hz 800/900, Pulse 800 – TETRA 800, modulation iDEN 820, CDMA 850, 18 Hz LTE Band 5 GSM 1800; 1720 CDMA 1900; Pulse 1 700 – GSM 1900; modulation 1845 1 990 DECT; LTE Band 1, 217 Hz 1970 4, 25;...
  • Page 63 Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.

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