User Manual - CkHealth.de
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1. User Manual for Vital Signs Monitor 3 3 Sensor Placement and Connection 3 3 1 CO Sensor Connection 3 3 1 1 Sidestream CO Sensor Connection Exhaust AF vent Ir eS Baie a i JA AS 2 C07 sample cell Receptacle AR Sensor Cable Sidestream CO Sensor Sample cell Figure 3 3 Demonstration for Sidestream CO Sensor Connection 1 Take out the CO Sensor and insert the CO Sensor Cable into the connector labeled CO on the connector panel of the monitor 2 The sample cell of the sampling cannula must be inserted into the sample cell receptacle of the CO Sensor as shown in Figure 3 3 A click will be heard when the sample cell is properly inserted Then connect to airway tube After finishing sensor connection and make sure that the air input end is exposed to room air and away from all sources of CO including the ventilator the patient s breath and your own Next turn on the CO switch at CO Setup Screen and then wait 2 minutes for the sensor warm up 3 Default Tubing Configuration sampling dehumidification sampling sample adapter tubing tubing filter cell fi j i a Fi Figure 3 4 Sampling line kit Single patient use Figure 3 5 Extending airway tube for connecting to sampling tube Single patient use User Manual for Vital Signs Monitor Figure 3 6 Wye Connector 4 Optional sampling cannula kits 1 T connector sampling cannula kits On2. Te CREATIVE MEDICAL Vital Signs Monitor PC 900A User Manual Shenzhen Creative Industry Co Ltd User Manual for Vital Signs Monitor This Manual is written and compiled in accordance with the IEC 60601 1 Medical electrical equipment Part General requirements for safety and MDD 93 42 EEC It complies with both international and enterprise standards and 1s also approved by State Technological Supervision Bureau The Manual is written for the current PC 900A Vital Signs Monttor The Manual describes in accordance with the Vital Signs Monitor s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details The Manual is published in English and we have the ultimate right to explain the Manual Version of This Manual Ver1 1 Revised date May 25 2010 All rights reserved Marks in the Manual 6 Warning must be followed to avoid endangering the operator and the patient A Attention must be followed to avoid causing damage to the monitor Note some important information and tips about operations and application 3502 2530002 I User Manual for Vital Signs Monitor Instructions to User Dear Users Thank you very much for purchasing our product Please read the following info
3. 1 when battery is used to supply power user should not charge the battery until the low battery alarm rings After line haul or long time storing using battery may not start the monitor please charge the battery 2 The battery should be charged for 10 to 15 hours 9 1 4 Service If the monitor has functional malfunction or is not working please contact the local dealer or our company and we are to offer the best solution as soon as possible for your satisfaction Only qualified service engineer specified by the manufacture can perform the service Users are not permitted to repair 1t by themselves 9 2 Cleaning Sterilization and Disinfection boob oboe eme Kept the monitor from dust It is recommended to clean the outer shell and screen of the monitor to keep it clean Only non corrosive cleanser such as clear water is permitted Use the cloth with alcohol to wipe the surface of the monitor and transducers and dry it with dry and clean cloth or simply air dry The monitor can be sterilized and disinfected please clean it first Switch off the monitor and disconnect the power cable before cleaning Do not let the liquid cleanser flow into the connector jack of the monitor to avoid damage Clean the exterior of the connector only Dilute the cleanser Do not let any liquid flow into the shell or any parts of the monitor Do not let the cleanser and disinfectant stay on its surface Do not perform hi
4. alarm range 1 100 SpO Lo low limit of SpO alarm range 0 99 PR 2 pulse rate alarm switch 2 indicates PR alarm is on X indicates PR alarm is off PR Hi high limit of PR alarm range 22 250 bpm PR Lo low limit of SpO alarm range 0 248 bpm gt gt PI display on means PI display is enabled off means PI display 1s disabled 4 4 3 Nurse Call Output level Source ALM H Im L Duration Probe off 01 20 14 50 Figure 4 10 Nurse Call Setup Screen ee User Manual for Vital Signs Monitor Output level two options low or high output levels are available When the calling system in hospital works in Normal Open mode low level should be selected When the calling system in hospital works in Normal Close mode high level should be selected Source three kinds of alarm sources can trig the nurse call high level alarm medium level alarm and low level alarm multi optional If you don t make choice nurse call signal will not be sent out Duration two options pulse or continuous output modes are available continuous the continuous mode of output means the nurse call signal will keep until the selected alarm source es disappear 1 e the signal will last from starting alarm to stopping alarm pulse the output nurse call signal is pulse signa
5. lt gt lt gt Balance balance gas adjust the concentration of balance gas Use this setting to correct for the compensation of the gas mixture administered to the patient Range 0 100 Agent Anesthetic agent select whether the anesthetic gas 1s supplied to patient two options on or off Use this setting for ensuring the accuracy CO monitoring when the anesthetic gas 1s supplied to patient Apnea Use this setting to set the no breaths detected time out This time out is the time period in seconds following the last detected breath at which the monitor will signal no breaths detected At this time all the measuring values will be cleared Range 10 60 s the default is 20 s 22 User Manual for Vital Signs Monitor Operation Instructions 1 Press A key or V key to move cursor to select parameter 2 Press Ml key to confirm and active this parameter setting 3 Press A key or W again to adjust or modify parameter value 4 Press MW key again to confirm and save the setting 5 After setting press mi key to return to upper level screen 4 4 2 SpO Setup PR MM Hi 180 Lo 40 PI display Probe off 01 19 30 07 Figure 4 9 SpO Setup Screen Screen Description lt gt SpO A SpO alarm switch amp indicates SpO alarm is on IX gt indicates SpO alarm is off SpO Hi high limit of SpO
6. 0 69mmHg 0 25mmHg 70 150mmHg H Flow rate 50ml min 10 ml min Sidestream 5 2 SpO Monitoring and Pulse Rate Monitoring A Sensor dual wavelength LED B SpO measurement range 3546 9946 C SpO measurement accuracy 75 99 2 50 74 3 D Pulse rate measurement range 30bpm 240bpm Pulse rate measurement accuracy 2bpm or 2 whichever is greater F Performance under low perfusion condition The measurement accuracy still keeps the above specification while the blood perfusion index 1s as low as 0 4 Display range of Perfusion Index 0 2 20 5 3 Recorder A Recording speed 25mm s 206 User Manual for Vital Signs Monitor B Recording speed accuracy lt 5 5 4 Power Requirement AC power supply voltage 100 250VAC AC power frequency 50 60 Hz Fuse specification T3 15AL 250V 5 X 20mm Internal power supply 12VDC rechargeable NU O W p Internal power supply rechargeable sealed lead acid battery 12V 2 3AH 5 5 Environmental Requirement Operating Environment Ambient temperature range 5 C 40 C Ambient relative humidity range 30 80 Atmospheric pressure 70kPa 106kPa Transport and Storage Environment Ambient temperature range 20 C 60 C Relative humidity 10 90 Atmospheric pressure 53kPa 106kPa 5 6 Classification Complied Safety standard IEC 60601 1 The type of protection against electric shock Class I equipment The degree of protection against ele
7. User Manual for Vital Signs Monitor Chapter 1 Overview 1 1 Features lt gt End tidal Carbon Dioxide EtCO Inspired Carbon Dioxide InsCO Respiration Rate RR SpO and Pulse Rate PR are displayed by big bright numerical LEDs lt gt CO waveform SpO plethysmogram and system parameters are displayed on dot matrix LCD screen lt gt CO measuring module with advanced technology for quick and accurate EtCO and RR measurement lt gt Unique SpO measuring technique ensures sensitive and accurate SpO PR and Perfusion Index PI measurement EtCO and SpO trend graph display for latest 12 24 or 96 hours Audible amp visible alarm with 3 levels of alarm events Nurse call output 1s available Built in printer is optional to print out waveforms and text information 1 2 Product Name and Model Name Vital Signs Monitor Model PC 900A 1 3 Intended Use This monitor is multi functional equipment designed for monitoring the vital physiological signs of the patient It is used to monitor continuous CO and SpO and report the End tidal Carbon dioxide EtCO inspired CO InsCO respiratory rate RR value pulse oxygen saturation value SpO pulse rate PR and perfusion index PI of the intubated and non intubated patient This equipment is applicable for use in hospitals in long term realtime monitoring of CO and SpO during anesthesia recovery It can be used in various depart
8. air Connectffr 7 BP Adapter Figure 3 7 2 Nasal Sidestream Cannula Kits Figure 3 8 3 Oral Sidestream Cannula Kits Figure 3 9 User Manual for Vital Signs Monitor 3 3 1 2 Mainstream CO Sensor Connection Sensor cable CO sensor gt Figure 3 10 Demonstration for Mainstream CO Sensor Connection 1 Take out the CO Sensor and insert the CO Sensor Cable into the connector labeled CO on the connector panel of the monitor 2 Snap the CO sensor onto the airway adapter as shown in Figure 3 10 A click will be heard when the airway adapter is properly inserted 3 Position the airway adapter in the patient s respiratory circuit as close to the patient as possible between the endotracheal tube and the ventilator circuit Next turn on the CO switch at CO Setup Screen and then wait 2 minutes for the sensor warm up Sens Mainstream SS p CO Sensor ang ro P 2 or Cable a To Patient Figure 3 11 Safety Introductions for CO Monitoring 6 CO Sensor is a precision measuring part please use it correctly and store it properly 6 Precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment 6 Failure of Operation If the CO Sensor fails to respond as described in this user manual DO NOT use it until approved for use by qualified personnel DO NOT position the sensor cables or tubing in any manner that may cau
9. display panel and power supply block etc gt The CO module measures EtCO and InsCO and calculates RR gt Besides supplying power to CO module the power supply board for CO collects all the data from the CO module including EtCO InsCO RR and CO waveform etc gt The SpO module detects PR and SpO via SpO probe and then calculates their values and provides SpO plethysmogram and Pl as well gt The main control unit is in charge of LED and LCD display keyboard input data storage printing and networking function User Manual for Vital Signs Monitor Chapter 3 Installation and Connection 3 1 Appearance 3 1 1 Front Panel 10 11 12 13 14 15 a CI ez 2007 08 09 11 30 25 16 21 AP FAN B Figure 3 1 Front panel illustration Description 1 Alarm indicator Alarm Indicator Red flashing High priority alarm Exceeding the limits or low voltage Orange flashing Medium priority alarm SpO probe off No CO sensor Greenlight Normal fo 10 11 12 13 14 15 16 17 18 User Manual for Vital Signs Monitor SpO display SpO value Unit SpO EtCO display EtCO value InsCO display InsCO value RR display respiration rate measuring value Unit rpm PR display pulse rate measuring value Unit bpm beats per minute Bar graph of pulse intensity LCD panel EtCO a
10. is 12 hours the upper trend graph will display SpO trend curve for last 12 hours lt gt cursor on enable the display of cursor on trend graph i e the vertical cursor line displayed in trend graph so the user can move the cursor to inspect the SpO value at the given time lt gt SpO indicate that the trend graph beside it is SpO trend Let the cursor stay here and press key to confirm then press A key or V key again to select trend graph type SpO SpO trend graph JEtCO EtCO trend graph as shown in Figure 4 6 21 50 01 50 05 50 12 hours cursor on Probe off 01 17 44 59 Figure 4 6 CO Trend Graph 4 3 2 Operation Instructions l Press A key or VW key again to select trend graph type EtCO or SpO 19 User Manual for Vital Signs Monitor 2 Then press A key or W key to highlight trend length or cursor on selection 3 Press MW key to confirm 4 Press A key or W key again to select value of trend length 12 24 96 hours if the selecting box stays in trend length option or to move the cursor 1f the selecting box stays in cursor on option Instructions for viewing the trend curve e Select cursor on and press MW key to confirm and cursor on becomes cursor off then you can press A key or Y key to move the vertical cursor the list box below wi
11. lights 3 The SpO sensor should not be used at a location or limb tied with arterial or blood pressure cuff or receiving intravenous injection 4 Do not fix the SpO sensor with adhesive tape or else it may result in venous pulsation and consequential inaccurate measurement result of SpO 5 Make sure the optical path 1s free from any optical obstacles like adhesive tape 6 Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater and direct sunlight etc 7 Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy 8 Please do not use the SpO sensor when having the MRI or burn may be caused by faradism 7 2 3 Clinical Limitations 1 As the measure is taken on the basis of arteriole pulse substantial pulsating blood stream 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 In this case the measurement will be more sensitive to interference 2 For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate 3 The drugs such as dopamine procaine
12. of rubber roller lock at the left 90 upwards to unlock it refer to the following figure with mark 3 Cut one end of the paper into triangle and load the paper from the underside of the rubber roller 4 Turn the roller clockwise to get the paper rolled and put the paper roll into the compartment 5 Pull the paper out of paper slot on the shield 6 Move the tab of the rubber roller lock 90 downwards to lock tt 7 Put the shield back in position and secure it Operation procedures for taking out printing paper roll 1 2 steps are the same with the 1 2 steps mentioned above for loading printing paper 3 Roll the loading roller anti clockwise and pull the paper out 4 5 steps are the same with the 6 7 steps mentioned above for loading printing paper a Rewind G Formfeed Figure 3 14 Loading and taking out printing paper 3 3 4 Battery Installation 1 Ensure that the monitor is not connected to AC power supply and the monitor is turned off 2 Open the battery cover and place the battery in the direction as shown in Fig 3 15 to insert the battery into any one of battery compartments Do not insert battery with their polarities reversed 3 Move the battery baffle to secure battery e User Manual for Vital Signs Monitor 4 Close the battery cover Battery Battery baffle Battery cathode Underside view Rubber gallus Battery cover Figure 3 15 Battery Installation Note e Do not insert battery
13. sensor by means of a pump This type of system 1s needed for non intubated patients When using mainstream CO sensors check the window for the patient secretions pooled on periodically Because that condition may affect the accuracy of the measurement or even make the sensor not work When using sidestream CO sensors there 1s a water trap or a part of the sampling tube with dehumidifying function Please periodically check the flow sensor and tubing for excessive moisture or secretion buildup 7 2 The Principle of SpO Pulse Measurement 7 2 1 Working Principle This monitor measures the pulse oxygen saturation SpO gt and pulse by means of the radiograph of infrared light and the red light emitted by LED through body s peripheral areas such as fingers whereby the photoelectric detecting circuits will analyze the absorptivity of the oxyhemoglobin and reduced hemoglobin respectively and give the photoabsorption rates before and after pulsation Using the measure of photoabsorption change due to pulsatory arterial blood flow caused by PLETH waveform the SpO can be obtained 29 User Manual for Vital Signs Monitor 7 2 2 Points to be noted in SpO and Pulse Measuring pama The finger should be properly placed see the attached illustration of this instruction manual or else it may cause inaccurate measurement result 2 Make sure that capillary arterial vessel beneath the finger 1s penetrated through by red and infrared
14. terminal with its polarities reversed or the monitor can not be started e Please take out the battery before transport or storage TAS User Manual for Vital Signs Monitor Chapter 4 Operations 4 1 Initial Monitoring Screen Insert the SpO sensor cable into the connector labeled SpO follow the instructions of Section 3 3 1 to connect the SpO sensor and its accessories and then connect to patient well The LCD will display the initial monitoring screen and it is the default display screen as well PI 3 PLETH Title Area Main Display Area mute C D 120 03 11 30 25 Prompt Info Area Figure 4 1 Default Display Screen The LCD screen will display the information by different display views short pressing mi key to shift screen display modes among display views SpO plethysmogram screen default screen CO waveform screen and trend graph screen Long pressing mi key will enter the setup menu screen For every display view the display area is divided into 3 parts title area main display area and prompt info area see Figure 4 1 The prompt info area contains 3 segment of information status or event indication at the left patient ID number in the middle real time clock at the right also see Figure 4 1 4 1 1 Screen Description Title area See Figure 4 1 lt gt PI 3 the perfusion index is 3 o it displays only when Setup Menu SpO PI Display is set as O
15. the figure below Figure 3 12 Finger clip SpO sensor placement 3 If the neonate SpO gt sensor is used please follow Figure 3 13 to connect Sensor adapter wrapper Y type sensor Figure 3 13 Neonate SpO sensor placement Safety Introductions for SpO Monitoring Continuous use of finger clip SpO sensor may result in discomfort or pain especially for those patients with microcirculatory problem It is recommended that the sensor should NOT be applied to the same finger for over two hours 6 SpO measuring position must be examined more carefully for some special patient Do NOT place the SpO sensor on the finger with edema or fragile tissue 4 Please do not allow the cable to be twisted or bended lt 12 User Manual for Vital Signs Monitor D Do NOT put the SpO sensor and pressure cuff on the same limb otherwise the NIBP measuring will affect SpO measuring and cause the alarm error Using nail polisher or other cosmetic product on the nail may affect the accuracy of measurement The fingernail should be of normal length Do NOT use the damaged SpO sensor kay E E The SpO sensor can not be immerged into water liquor or cleanser completely because the sensor has no capability of waterproofness 3 3 3 Loading printing paper Operation procedures for loading printing paper 1 Press both OPEN notches with force on printer shield with two thumbs to open it 2 Move the tab
16. E LEE OEE T IEO 7 a E A eh eg Z 3 3 SENSOR PLACEMENT AND CONNECTION zu ee 8 Hl COS CAS OF CONMECIION Geniessen 8 IN ONNECL A AHA 11 o E KO BN 13 IA BANGIN ASTA NANO nee Ga NGA 13 CHAPTER 4 OPERA TIONS 28 Ba A AA ANNA 15 A INITIAL MONITORING SCREEN ia 15 ATP ORCOS CAPO AA ASA ue ee ie A 13 hd OPTa NOn AINSIFUCHONS atada 16 A 2 COs MONITORING SERBE NE 85 0588 a KG SANG BNG BAG LOG AGA e LAG LANG NA EN NG 17 SES ATI E PO ae ee o E E E A E NR 17 ALLA DET AMON INSITUCHONS lt A AA A lada 18 43 TREND GRAPH DISPLAY nee 18 ADSL CIC AO COM NA NAAN ANN aaa 19 ALA CIATION AA AA AA 19 44 SETUP MENU SCREEN ANNA AA 21 44 1 CO SCNID naaa bet i itch trate AS aria ata A A A A 21 AN ANA AA See 23 ANS CO AR 23 NANA een 24 HI Ballen IN Osa ee ee ee A ee 23 44 0 DAGA Naa iaa 25 AUS a Ba Al SEN Nas nn ee ae 25 CHAPTER 5 TECHNICAL SPECIFICATIONS 0000000ss0000000000000000000000000000 000000000 0000000000000 0000000000000 26 IIl User Manual for Vital Signs Monitor Sal CO MONITORI ee NAA ANA ada ada 26 5 2 SPO MONITORING AND PULSE RATE MONITORING ccocccnoccnnocnnoconnncnnaronnncnnarononcnnanonnnrcnnoconarcnunccnaronnns 26 EE RT ORI a ae estate cia 26 S2 OW ERR EI OUTRE MEIN Trois locas 27 5 ENVIRONMENTAL REQUIREMENTS ie 27 DOC ICAT O N ee ee seen AA AA AA AA AA 21 5 7 DEFAULT ALARM LIMITS AND SETTING RANGES ariete dd dida adas 24 CHAPTER 6 PACKAGING AND ACCESSORIES ccssccsssccsscccssccsscccscccsccccscccsccccscccsccesccc
17. N lt PLETH Mark of SpO plethysmogram when PLETH displays in title area the main display area will be SpO plethysmogram and this display screen 1s the default screen Main display area See Figure 4 1 When SpO sensor is placed on the patient and connected to the monitor well a trace of sweeping waveform plethysmogram will be displayed in the main display area as shown in Figure 4 1 If the SpO sensor is disconnected from the monitor or off from the patient the plethysmogram will become a base line in main display area and Probe off will appear at the left side of prompt info area as shown in Figure 4 2 15 User Manual for Vital Signs Monitor Probe off 01 17 44 59 Figure 4 2 Probe Off Prompt Info Area See Figure 4 1 lt gt Status or event indication segment This segment will display the probe status CO sensor status alarm silence counting down timer over limit warning and other error messages for technical warning If more than one event occurs or more status appears the indication message will be displayed alternately at this segment mute C D XXX the counting down timer of alarm silence 1s XXX seconds This prompt message appears only when the alarm silence is enabled Note refer to Appendix I for detailed explanations Patient ID segment 03 Patient ID number Real time clock segment 11 30 25 the current time 4 1 2 Operation Instructi
18. ber 01 100 adjustable Note If the patient ID is changed all the history data will be cleared that means SpO trend graph and EtCO trend graph will become empty 4 4 6 Date Time yy 07 mm os aaja hh 10 mm 15 ss 20 Probe off 01 12 17 50 Figure 4 13 Data Time Setup Screen lt gt yy07 mm09 dd 21 date setting 07 09 21 shows the date is September 21 2007 lt gt hh10 mm15 ss 20 time setting 10 15 20 shows the time is10 15 20 4 4 7 Recover Default Settings On Setup Menu screen press A button or W button to shift cursor to Default and then press MW button all the setting parameters will be reset to factory default setting value _25 User Manual for Vital Signs Monitor Chapter 5 Technical Specifications 5 1 CO Monitoring Technology Infrared absorption method Mode of Sampling Sidestream or Mainstream Measuring parameters Respiration Rate EtCO and InsCO Jaw CO Response Time Sidestream lt 3seconds includes transport time and rise time Mainstream lt 60ms rise time E Typical measurement range EtCO 0 150mmHg InsCO 3 50mmHg Respiration Rate 2 150bpm Sidestream or 0 150bpm Mainstream F CO Accuracy 0 40mmHg 2mmHg 41 70mmHg 5 of reading 71 100mmHg 8 of reading 101 150mmHg 10 of reading NOTE Gas temperature at 25 C for Sidestream Gas temperature at 35 C for Mainstream G CO Resolution 0 1mmHg
19. ctric shock Type BF applied part 5 7 Default Alarm Limits and Setting Ranges Alarm range Default Parameter LISO pm RR 0 149 rom R Lo 0 160 mmHg 70mmHg ih Low 0 159 mmHg 10mmHg Lo O 27 User Manual for Vital Signs Monitor Chapter 6 Packaging and Accessories 6 1 Packaging The product is packed in high quality corrugated cartons with foam inside to protect the equipment against damage in the shipping and handling process Weight Details see the indication on the outer package Dimension 360 L x320 W x410 H mm 6 2 Accessories For Mainstream For Sidestream Mainstream sensor Sidestream Sensor One set One set CAPNOSTAT 5 LoFlo C5 Airway adapter One piece Sampling Line Kit One piece SpO probe One piece SpO probe One piece Power cord One piece Power cord One piece Grounding wire One piece Grounding wire One piece User manual One copy User manual One copy Warranty One copy Warranty One copy Quality Certificate One copy Quality Certificate One copy Dust cover One piece Dust cover One piece Packing list One copy Packing list One copy Note The accessories are subject to change Detailed items and quantity see the Packing List 28 User Manual for Vital Signs Monitor Chapter 7 Working Principle 71 CO Measurement 7 1 1 Working Principle The principle 1s based on the fact that CO molecules absorb infrared light energy of s
20. eesceees 28 OL PACKAGING sauren res 28 02 ACCESSORIES een NANANA idad 28 CHAPTER 7 WORKINGPRINGIPEE 3NA KANINANG IBAAN NANG 29 Lal NMS IR IM Weta ence tetera a e NA Gn a DA Sana ae 29 Dodd INVOCA AP AA 29 74 2 Mainstream Vs Sidestream SQMPUine crus sziacsunisdacswasatacsun a psn akan baa aka anakan bkas aba 29 7 2 THE PRINCIPLE OF SPO gt PULSE MEASUREMENT 2202000 0004000 29 RL Working Principle aa ANA AAA 29 7 2 2 Points to be noted in SpO and Pulse Measuring 000000200000aaaaaaaaaaaaasasaa saaan 30 PERES IR WI NT LANG LI BA AS A AA MA MATA 30 CHAPTER 8 TROUBLESHOOTING 5000 ecc 31 Bal INO DISPEAYON THE SCREEN a 31 02 NOE TCOBAND SROs RESULT datada isos 31 8 3 BLANK PRINTED PAPER aa 31 BESSER O 31 CHAPTERS MAINTENANCE NATN 32 al SERVICE ANDE XA MIN ATION 20 ii EGG 32 OL AN TONTON ON e e aE ao 32 PLSEROMMEMANIeNaN Ce ss ss AA 32 0 1 5 B llery Maintenance a NG dd 32 O a 6x A Bt A ee 33 9 2 CLEANING STERILIZATION AND DISINFECTION ccscccsscccsscccscccssccesccesccesccessccescceusceuseceescenseceuscss 33 9 3 CLEANING STERILIZATION AND DISINFECTION OF ACCESSORIES ccccssccsscccsccescceescccscccusccesscensces 34 FS TORE AAA greta ce ewe se eee 34 9 3 ERANSPORTATION ste adidas 34 APPENDIX ss rennen 35 EPROMPFINEORMA TIONEXPEANATIONS O AA AN NATA MA NINANG pA GANG ER 35 II TYPICAL PRESSURES AND CO READINGS AT ALTITUDES c ccecccseccscccssccesccessccesceesccescceusccessceusces 36 IV
21. er or the condition of the patient 2 Probe off Please check the connection of the probes Note In case of trouble of this machine in the service follow the instructions below to eliminate the problem first If the attempt fails contact the dealer in your local area or the manufacturer Do not open the cabinet without permission Aj User Manual for Vital Signs Monitor Chapter 9 Maintenance 9 1 Service and Examination 9 1 1 Daily Examination Before using the monitor the checks below should be carried out Check the monitor for any mechanical damage Inspect the exposed parts and the inserted parts of all the leads and the accessories Examine all the functions of the monitor that are likely to be used for patient monitoring and ensure that it is in good working condition Make sure that the monitor is grounded properly Pay close attention to the fluctuation of the local power supply voltage A manostat is recommended when necessary In case any indication of damage about the function of the monitor is detected and proven it is not allowed to apply 1t to the patient for any monitoring 9 1 2 Routine Maintenance After each maintenance or the yearly maintenance the monitor can be thoroughly inspected by qualified personnel including function and safety examinations NZ NZ If the hospital fails to carry out a satisfactory maintenance program about the monitor it may get disabled and harm the patie
22. gh pressure sterilization to the monitor Do not put any parts of the monitor in the liquid 33 User Manual for Vital Signs Monitor amp Donot pour the disinfector on its surface while sterilization 9 3 Cleaning Sterilization and Disinfection of Accessories It is recommended to use a cloth dampened with isopropyl alcohol 70 a 10 aqueous solution of sodium hypochlorite bleach a 2 gluteraldegyde solution ammonia mild soap or disinfectant spray cleaner to clean the accessories including sensor cable and plugs 6 Do not use damaged accessories Accessories can not be entirely immerged into water liquor or cleanser 6 Do not use radial steam or epoxyethane to disinfect accessories 9 4 Storage If the equipment will not be used for long period of time wipe 1t clean and keep it in the packaging which shall be kept in a dry and good ventilation place free from dust and corrosive gases 9 5 Transportation This monitor should be transported by land vehicle or railway or air in accordance with the contractual terms Do not hit or drop it with force 34 User Manual for Vital Signs Monitor Appendix I Prompt information explanations Prompt Info Response Check that the sensor is properly plugged in Reinsert the sensor If error persists contact the local dealer or manufacturer for servicing Need CO zero To clear check airway adapter and clean if necessary If this does not correct the error perf
23. he upper alarm limit of respiration rate Range 1 150 rpm RR Low Setting the lower alarm limit of respiration rate Range 0 149 rpm Gain CO waveform scale x1 2 waveform reduced to half of nominal scale x1 nominal waveform scale x2 waveform with doubled scale Baro barometric pressure set ambient barometric pressure It can be determined by barometer or the ambient altitude Altitude can be used to determine the typical barometric pressure if a barometer is not available refer to Appendix Typical Pressures and CO Readings at Altitudes for details Range 400 850 mmHg Note When the cursor stays at Baro item press W key to move cursor to next item at another CO Setup screen view as shown in Figure 4 7B CO Setup lt gt gt gt Page down icon When cursor stays in the Baro filed press Y key to enter CO Setup II Screen Zero CO Zero The CO zero must be carried out in a drafty place Set the option as on and press W key to conform and then the result will be displayed on the screen several seconds later When the CO2 zero 1s done successfully the set of this 1tem will automatically change to off and the corresponding information will display in prompt info area Note you should perform CO zero only when Need CO zero prompts on the screen Otherwise 1t 18 unnecessary to perform this operation
24. hift cursor to corresponding functional group setting 2 Pres W key to confirm and enter into corresponding functional parameter setup screen 3 Pres key under the setup menu or its submenu the SpO waveform will be printed 4 Press m to exist from Setup Menu Screen Note At Setup Menu Screen or its submenu screen when pressing Ey key the default display screen will be printed The following will cover each functional parameter s setting up 4 4 1 CO Setup CO Setup CO Setup Probe off 01 19 30 07 Probe off 01 19 30 09 Figure 4 8A CO Setup I Figure 4 8B CO Setup II Screen Description gt Switch choosing the mode of CO It is recommended that the switch is turned on only when 21 User Manual for Vital Signs Monitor there 1s a need to monitor CO parameter This can not only reduce the power consumption and also extend the life of the CO module Unit choosing the EtCO and the minimum InsCO It can be set as kPa mmHg and Et A EtCO alarm switch A indicates EtCO alarm is on X indicates EtCO alarm 1s off Et High Setting the upper lower alarm limit of EtCO Range 1 160 mmHg Et Low Setting the upper lower alarm limit of EtCO Range 0 159 mmHg RR A respiration rate alarm switch 422 indicates respiration rate alarm is on X indicates respiration rate alarm is off RR High Setting t
25. is in demo status The entire signal 1s generated During DEMO from the monitor and waveforms and values are displayed for demo Low battery Low bullt in battery voltage Please recharge the battery 235 User Manual for Vital Signs Monitor II Typical Pressures and CO Readings at Altitudes EtCO Reading 236 Manufacturer Shenzhen Creative Industry Co Ltd Address 2 F Block 3 Nanyou Tian an Industry Town Shenzhen GD 518054 P R China Tel 486 755 2643 3514 Fax 486 755 2643 0930 E mail market creative sz com 1 01 1 Website www creative sz com
26. isplay area If the CO sensor cable is disconnected from the monitor the CO waveform will become a base line in main display area as shown in Figure 4 3 Prompt Info Area lt gt Status or event indication segment If the CO sensor cable 1s disconnected from the monitor the CO waveform will become a base line 17 User Manual for Vital Signs Monitor in main display area and No CO2 sensor will appear at the left side of prompt info area as shown in Figure 4 3 Note CO sensor needs to warm up Prior to CO measurement please wait for sensor warm up Otherwise the measuring result may be inaccurate 4 2 2 Operation Instructions ip 4 OF key press this key to shift display mode a RS Ey key press it to print a trace of CO waveform press it again to stop printing a Ss x key press 1t to enable disable alarm silence gt A key or VW key press it to change CO waveform scale It can also be set in the item of Menu Setup CO Setup Gain 18 User Manual for Vital Signs Monitor 4 3 Trend Graph Display Short pressing mi Display key to shift the screen view to trend graph display screen as shown in Figure 4 5 Trend graph 01 50 05 50 Trend length Prohe off 01 17 44 59 Figure 4 5 SpO Trend Graph 4 3 1 Screen Description lt gt 12 hours the trend length of trend graph three options 12 24 or 96 hours when the selection
27. l which lasts for 1 second When several alarms occur at the same time only one pulse signal will be sent out Note Nurse Call function can not be regarded as main alarm notice method please do not entirely relay on it You should combine parameter values with alarm level and patient s clinical behavior and symptom to determine patient s status 4 4 4 System Setup bh Lang TENG hackl te contract care mode BT SD 01 20 14 50 Figure 4 11 System Setup Screen VOL set beeper volume 0 7 level adjustable the set 0 1 e no sound key beep to turn on off key beep LANG language selection Two options ENG for English or CHN for Chinese priority priority of PR value source displayed on the numerical LED The default set is PR 1t can not be set backlite turn on off backlight contract adjust LCD display contract 0 31 level adjustable care mode Demo shows the demo waveforms and data In the demo state all the signals and data are generated from the patient monitor for demonstration and testing purpose Real shows the real time waveform 1 e normal monitoring status BT SD turn on off the pulse beeping sound 24 User Manual for Vital Signs Monitor 4 4 5 Patient Info Patient Info m Probe off OL 12 14 50 Figure 4 12 Patient Info Screen lt gt ID change or set current patient s ID num
28. ll display SpO EtCO value and the time value at the point where the cursor stays Move cursor back and forth this way you can view the SpO EtCO trend 12 24 96 hours long Press MW key again to exit trend viewing e When pressing A key or V key to move cursor the moving step 1s variable The rule is that the initial step is 1 point after pressing A or Y key towards the same direction for 5 times the step becomes 5 points and with 5 more pressing the step becomes 10 then 20 No matter what step is as long as you press A or Y key towards the other direction the step becomes 1 and towards the other direction 5 press a mi key press this key to shift display mode s Es key press it to print the current displayed trend graph s x key press t to enable disable alarm silence 20 User Manual for Vital Signs Monitor 4 4 Setup Menu Screen At any display view screen long time press mi Display key to shift the screen to Setup Menu screen as shown in Figure 4 7 All the functional parameters of the system can be set through Setup Menu Setup Menu CL Patient Info Sp Date Time Nurse Call Default System Probe off 01 19 56 07 Figure 4 7 Setup Menu Screen There are 7 functional groups for setting parameters CO SpO Nurse Call System Patient Info Date Time and Default on the Setup Menu Screen 1 Press A key or V key to s
29. ments at hospital such as Intensive Care Unit ICU Emergency Department Respiratory Care and Operation Room It also adapts to use in monitoring patient during inter hospital transport and intra hospital transport for example road ambulance fixed wing and rotary wing aircraft and first aid station User Manual for Vital Signs Monitor 1 4 Symbols on the Monitor Pa nh lt nH gt Alarm Silence Print Up OK Down Setup Menu AC Power a A ls a r Qt amp DC Power Type BF applied part Type CF applied part with defibrillator protection Warning refer to User Manual Equal potential terminal Nurse call output User Manual for Vital Signs Monitor Chapter 2 Operating Principle 2 1 Conformation The monitor consists of the main control unit power supply board for CO SpO module display panel printer power supply block etc and the related accessories for CO sensor and SpO measurement 2 2 Overall Structure The overall structure of the monitor is shown in Fig 2 1 Operating Power Suppl COZ Sensor EUA Power Supply nsco2 RR H Board for CO LED Display Pulse Oxygen Central p 02 Probe EY Saturation Module FT LED Display S02 PR Processing Networking Built in Printer Figure 2 1 PC 900A Vital Signs Monitor is module designed product it consists of power supply board for CO CO module SpO module main control unit built in printer optional
30. monitor Note Short time pressing power button for entering the Power Saving Mode screen then according to your need to make the device stay in the power saving mode or exit from power saving mode this function is optional and needs hardware support 20 SpO SpO sensor connector 21 CO CO sensor connector 22 TEMP temperature probe connector reserved 23 ECG ECG cable connector reserved 3 1 2 Side Panel The built in thermal printer is on the left panel It is easy for user to print waveform and data 3 1 3 Rear Panel Figure 3 2 Rear Panel Introduction to the rear panel Handle Fan Nameplate FUSE 2XT3 15 A Fuse holder Fuse specification T3 15AL 250V D5 X20mm AC100 250V AC power supply socket Loudspeaker Mounting hole for hanging the monitor NET serial communication port which 1s used to network with central monitoring system optional NI Mm YN A UQ N m Nurse call connector 10 Y Equipotential ground terminal _6 User Manual for Vital Signs Monitor 3 2 Installation 3 2 1 Opening the Package and Check 1 Open the package take out the monitor accessories from the box carefully and place it in a safe stable and easy to watch position 2 Open the accompanying document to sort the accessories according to the packing list Inspect the monitor for any mechanical damages Check all the accessories for any scratch or deformity especially on connector wire a
31. nd InsCO measuring unit indicator the unit can be set in the item of Menu Setup CO Setup unit Three options mmHg kPa Yo IK Alarm silence key Enable disable alarm silence function When the alarm silence indicator on the left of keys is on it means the system is in alarm silence status and it lasts for 2 minutes When finishing counting down the system will resume normal alarm status automatically 1f alarm event occurs at this time the alarm sound will be effective again Alarm silence indicator When it is on it indicates that the monitor stays in alarm silence status Es Print print SpO CO trend and waveforms A Up shift cursor forward upward OK to perform confirmation or modification V Down shift cursor backward downward Y Display shift LCD display modes AC Power indicator y DC Power indicator The monitor is using mains power supply ON green ON green and the battery is full when the battery is installed ON green The battery is being used FF Status Ser The battery s being used but battery O ON orange blinking voltage is low the beeper also gives warning The monitor is using mains power supply ON green ON orange and the battery 1s being recharged The battery 1s being recharged while the ON green OFF monitor 1s off User Manual for Vital Signs Monitor 19 O Power button Press power button for 3 seconds to start the monitor or shut off the
32. nd probe parts If in doubt please contact the local dealer or our company in case of any problems We are to offer you the best solution for your satisfaction 3 2 2 Connecting the Power Supply 1 When powered by AC mains power supply Make sure that the AC mains power supply is within 100 250VAC with 50Hz or 60Hz Use the power cord provided by the manufacturer Insert one end of it to the power port of the monitor and the other end to the single phase mains power outlet with protected earth Caution if necessary make the monitor grounded properly by the provided grounding wire 2 When powered by built in battery 9 Install battery refer to Chapter 3 3 4 Battery Installation Caution it s better to recharge the battery after it is used up the charging time should be 13 15 hours long 3 2 3 Starting the Monitor The system performs self test and enters initial display after switching on the monitor and the orange alarm indicator blinks to inform that the user can begin operating it 9 Check all the applicable functions to make sure that the monitor works normally If the battery is applied please recharge it after using the monitor to ensure sufficient power storage A Do not use the device to monitor the patient if the device appears obvious damage or indication of fault Please contact the local dealer or our company A After the monitor is switched off it s recommended to delay 1 minute to start it again ae
33. nt s safety and health In case of ECG leads damage or aging please replace the lead If there is any indication of cable and transducer damage or they deteriorate they are prohibited from any further use The adjustable units in the monitor such as potentiometer are not allowed to adjust without permission to avoid unnecessary failures that affect normal application 9 1 3 Battery Maintenance NZ Please pay attention to the polarity of battery do NOT insert it into battery compartment with reversed polarities Do NOT use the batteries manufactured by other companies if being inserted the device will may be damaged In order to avoid damaging the battery do NOT use other power supply device to charge the battery 305 n VIN p dl dl dl dl YIN WIN WIN WIN a User Manual for Vital Signs Monitor After battery ageing phenomenon occurring to avoid explosion risk do NOT throw the battery into fire Do not hit or strike it with force Do not use this battery on other devices Do not use this battery below 10 Cor above 40 G Dispose of the battery the local law should be followed It is recommended to use the battery once a month to ensure its strong power supply capacity and long service life and recharge it after running out of the power In order to maintain battery supply time and prolong battery lifetime please use the battery once a month and do not charge it until it is used up each time Note
34. ons Ks mi key press this key to shift display mode Ey key press it to print a trace of SpO plethysmogram press it again to stop printing x key press 1t to enable disable alarm silence e User Manual for Vital Signs Monitor 4 2 CO Monitoring Screen Insert the CO sensor cable into the connector labeled CO follow section 3 3 1 s instruction to connect the CO sensor and its accessories and then connect to patient well next turn on the CO Switch Short time press mi Display key to shift the screen view to CO monitoring screen as shown in Figure 4 3 CO xl No CO2 sensor OS 11 30 25 Figure 4 3 CO Monitoring Screen No CO sensor If the CO sensor cable is disconnected from the monitor the CO waveform will become a base line in main display area as shown n Figure 4 3 When CO tube is attached on the patient and CO sensor cable 1s connected to the monitor well CO waveform will be displayed in the main display area as shown in Figure 4 4 CO2 03 11 30 25 Figure 4 4 CO Monitoring Screen 4 2 1 Screen Description Title area lt gt CO indicate the current waveform displayed is CO waveform Main display area lt gt x1 CO waveform scale Three options x1 2 waveform reduced to half of nominal scale x1 nominal waveform scale x2 waveform with doubled scale lt gt CO waveform will be displayed in the main d
35. orm an adapter zero One of the following conditions exist This error occurs whenever the pneumatic pressure is outside the expected range CO module fail Check airway Check that the sampling line is not occluded or kinked To clear clean airway adapter if mucus or moisture is seen If the adapter is clean perform a Capnostat ZETO Usually caused when the airway adapter is removed from the sensor or when there is an optical blockage on the windows of the airway adapter May also be caused by failure to perform sensor zero to when adapter type 1s changed Check that the sensor is properly plugged in Reinsert the sensor The CO module cable is not plugged in Please connect the No CO sensor CO module to the monitor properly One of the following conditions exist Breaths have been detected by the CO module within the last 20 seconds while CO zero was attempted Check that the sensor is properly plugged in Reinsert or reset the sensor 1f necessary Temperature 1s not stable The set of CO monitoring switch 1s off Please set as on in CO Setup screen One of the following conditions exist The sensor is connected unwell CO zero fail Sensor warm up Sensor under temperature This condition 1s normal at startup Temperature not stable CO is sleevin The set of CO monitoring switch 1s off Please set as on 2 ping in CO Setup screen The monitor
36. pecific wavelengths with the amount of energy absorbed being directly related to the CO concentration When an IR light beam is passed through a gas sample containing CO the electronic signal from a photodetector which measures the remaining light energy can be obtained This signal 1s then compared to the energy of the IR source and calibrated to accurately reflect CO concentration in the sample To calibrated the photodetector s response to a known concentration of CO is stored in the monitor s memory The monitor determines CO concentration in the breathing gases by measuring the amount of light absorbed by these gases FtCO is display as a numerical value in millimeters of mercury mmHg percent or kilopascals kPa In addition a CO waveform capnogram may be displayed which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement Respiration rate 1s calculated by measuring the time interval between detected breaths 7 1 2 Mainstream vs Sidestream Sampling Mainstream CO sensors are placed at the airway of an intubated patient allowing the inspired and expired gas to pass directly across the IR light path The major advantages of mainstream sensors are fast response time and elimination of water traps Sidestream CO sensors are located away from the airway requiring a gas sample to be continuously aspirated from the breathing circuit and transported to the
37. prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO measurements 4 As the SpO value serves as a reference value for judgement of anemic anoxia and toxic anoxia the measurement result of some patients with serious anemia may also present as good SpO value 30 User Manual for Vital Signs Monitor Chapter 8 Troubleshooting 8 1 No Display on the Screen Shut down the machine and unplug the power Use a universal meter to check 1f the outlet has proper voltage if the power cable is in good condition and if the power cable is properly connected with this apparatus or outlet Remove the fuse from the back cover of this machine and make sure it is in good condition 8 2 No EtCO and SpO Result 1 Check that the CO module cable 1s properly plugged in Reinsert or reset the sensor if necessary and the set of CO monitoring switch is on 2 Check that the SpO sensor cable is properly plugged in and the light in SpO sensor is flash 3 Ifthe problems still exist please contact the local dealer 8 3 Blank Printed Paper 1 Check whether the printing paper is installed with its face reversed Please reinstall it and let the sensitive page face upward 2 If the problems still exist please contact the local dealer 8 4 System Alarm 1 When the parameter value is higher or lower than the alarm limits the alarm will ring Please check whether the alarm limit value is prop
38. rmation very carefully before using this device Read these instructions carefully before using this monitor These instructions describe the operating procedures to be followed strictly Failure to follow these instructions can cause monitoring abnormity equipment damage and personal injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality personal injury and equipment damage due to user s negligence of the operation instructions The manufacturer s warranty service does not cover such faults NZ NZ NZ Do not use this device in an environment with ignitable or inflammable gas Do not place the monitor in any position that may cause it to fall on the patient Check the safety and performance of this monitor every time before using it to ensure it works normally and safely Ensure the monitor is grounded reliably before using it if the integrity of grounding connection is in doubt the monitor should work by using the built in battery 6 Equipment connected with this monitor should be IEC 60601 1 complied 6 Turn off the monitor and take away the sensors from the patient during MRI scanning Otherwise it may cause burn to the patient and the quality of MRI image or the measurement accuracy of the monitor may be affected Although biocompatibility tests had been done to all the applied parts some exceptional allergic patients may still have anaphylaxi
39. s Do NOT apply to those who suffer from anaphylaxis All the cables and hoses of the applied parts should be kept away from the patient s neck to prevent any possible choke of the patient All the parts of the monitor should NOT be replaced at will If necessary please use the components provided by the manufacturer or those 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 If the monitor falls off accidentally please do NOT operate it until its safety and performance have been carefully tested and positive testing results obtained Dispose of the device and its accessories the local law should be followed User Manual for Vital Signs Monitor Table of Contents CHAPTER UOVERVIEW usa aran convent ae 1 a AA NA l 12 PRODUCT NAME AND MODE Ltda kakanan a R E kan ana l 1 3 INTENDED USE id 0a ea haha l 1 4 SYMBOLS ON THE MONITOR ii 2 CHAPTER 2 OPERATING PRINCIPLE 2 0 AA 3 2 1 2 ONOR NANO Naa AO NAA kaa 3 2 OVER O ROTURA ANA ANA NAA AA AA ee ee 3 CHAPTER 3 INSTALLATION AND CONNECTION 22000000000000000000000000000000000000000 0000000000000 ns snnnnnnnnne 4 3 AP BE AIAN CB un eisen 4 SL TONG Panel naaa ANNA AA AA eee aaa 4 ML VO LON ARA AAA AAA ec Ei eee O A L O O 32 INS ALTO Adoos 7 3 2 1 Opening the Package and nl E ee E 7 322 C ONNCCHNS Ihe POWER SUP DIY mawa ksa A N A E
40. se 10 User Manual for Vital Signs Monitor entanglement or strangulation 6 Support the airway adapter to prevent stress on the ET tube 6 Reuse disassembly cleaning disinfecting or sterilizing the single patient use CO airway adapters may compromise functionality and system performance leading to a user or patient hazard Performance is not guaranteed if an item labeled as single patient use is reused 6 Inspect the sidestream on airway adapters and sidestream sampling kits for damage prior to use DO NOT use the sidestream on airway adapters and sidestream sampling kits if they appear to be damaged or broken 6 If the CO waveform Capnogram appears abnormal inspect the CO airway adapters and replace if needed 6 Periodically check the CO Flow sensor and tubing for excessive moisture or secretion buildup Do not use then if there is excessive moisture or exterior condensation 6 Electric Shock Hazard The CO Sensor contains no user serviceable parts 6 Refer service to qualified service personnel Do not open the sensor cabinet at will as electric shock hazard may occur 6 Place the exhaust vent of the CO Sensor in drafty ambient and do not let anything block the exhaust vent 6 Always disconnect the CO Sensor before cleaning Do NOT use if it appears to have been damaged Refer servicing to qualified service personnel 6 DO NOT sterilize or immerse the CO Sensor in liquids Es When changing sampling t
41. ube it is suggested choosing the default sampling tube with dehumidifying function The sampling tube without dehumidifying function may be easily blocked by excessive moisture Use life ordinary sampling tube 6 12hours the sampling tube with dehumidifying function about 120hours Es If the measurement appears abnormity caused by sampling tube block please replace it Es The total length of the sampling tube and extending airway tube shouldn t be longer than 3 meters too long may cause measurement abnormity If using T connector sampling cannula kits please insert the sampling tube with the tubes upward to avoid the affects of excessive moisture Es Altitudes are different in different area so set the Barometric Pressure setting value as the ambient barometric pressure Es When stopping CO monitor please disconnected the CO sensor from the patient monitor 3 3 2 SpO Sensor Connection SpO sensor is a very delicate part Please follow the steps and procedures in operating it Failure to operate it IT User Manual for Vital Signs Monitor correctly can cause damage to the SpO sensor Operation procedure 1 Connect the SpO sensor to the connector labeled SpO When unplugging the probe be sure to hold the head of the connector and pull it out 2 Ifthe finger clip SpO sensor is used insert one finger into the sensor index finger middle finger or ring finger with short nail length as shown in
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