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100

Dakewe (Shenzhen) Medical Equipment Co., Ltd

Table II: Electromagnetic immunity

Electromagnetic immunity

Immunity test items

Basic standards

Test values

Performance

criteria

Electrostatic discharge

(ESD)

IEC61000-4-2

Contact discharge: ±2kV, ±4kV

Air discharge: ±2kV, ±4kV, ±8kV

B

Radio frequency

electromagnetic field

IEC61000-4-3

3V/m (80 MH

z

-1GH

z

)

3V/

m

(1.4GH

z

-2GH

z

)

1V/m(2.0GH

z

-2.7GH

z

)

A

Pulse cluster

IEC61000-4-4

Power cord: ±1kV(5/50ns,5kHz)

B

Surge

IEC61000-4-5

Line to ground: ±2kV

Line to line: ±1kV

B

Radio frequency

transmission

IEC61000-4-6

Power cord: 3V, 150kHz- 80MHz,

80%AM

A

Power frequency magnetic

field

IEC61000-4-8

3A/m, 50/60Hz

A

Voltage sag and interruption

IEC61000-4-11

1 cycle, 0%

5/6 cycle, 40%;

25/30 cycle, 70%;

250/300 cycle, 5%

B
B
C
C

Performance criteria:
A. In the test, the performance is normal within the specified limit.
B. In the test, the function or performance is degraded or lost temporarily, but can restore automatically.
C. In the test, the function or performance is degraded or lost temporarily, and cannot restore until reference or
system operation by the operator

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Содержание HP300 Plus

Страница 1: ...HP300 Plus Automatic Tissue Processor User s Manual Revision V1 4 English Version Jan 2023...

Страница 2: ...treet Pingshan District Shenzhen China Production Address Floor 5 Building B No 2 Luhui Road Jinsha Community Kengzi Street Pingshan District Shenzhen China After sales Service Organization Dakewe She...

Страница 3: ...e instrument which includes the instrument s structural features technical characteristics instructions for use simple troubleshooting maintenance etc For your ease of use this instrument Before use b...

Страница 4: ...Manual organizations or personnel are encouraged to give us feedback for updating It is also important to note that we shall not be liable for any direct or indirect economic loss or damage caused by...

Страница 5: ...cs of the Instrument 14 3 3 Technical Parameters 18 3 4 Compatible Reagents 20 4 First Installation 21 4 1 Installation Requirements 21 4 2 Unpacking and Installation 21 4 3 Host Hardware 24 4 3 1 Ins...

Страница 6: ...ne button automatic fluid change 78 8 Start Program 79 8 1 Manual Running of the Dehydration Program 80 8 2 Program Operation Panel 85 8 3 End Program 86 9 Cleaning and Maintenance 87 9 1 Rinse Progra...

Страница 7: ...Dakewe Shenzhen Medical Equipment Co Ltd 3 13 Electromagnetic Compatibility Indicators 99 14 RFID Registration for the United States of America and Canada 101...

Страница 8: ...oided may result in death or serious injury Note Indicating information that is not related to risk but is very important Follow this User Manual IVD medical device The symbol indicating separate coll...

Страница 9: ...precautions Serial number Manufacturing date Manufacturer No stacking Limited height of 2 floors accessory cases only Indicating the correct vertical position of the packing container Goods are fragi...

Страница 10: ...anual Any other ways of use are regarded as inappropriate 1 3 Working principle The user puts the specimen with tissue into the tissue processing tank of the instrument and then clicks to start the pr...

Страница 11: ...7 Software release version V01 As described in nameplate Be sure to observe the safety instructions and warnings in this Chapter Even if you are already familiar with the operation and use of the pro...

Страница 12: ...boratory use Part 1 General requirements 2 IEC61010 2 101 2018 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro d...

Страница 13: ...mitted original accessories Do not remove or modify protective devices of the instrument and accessories Only authorized maintenance personnel are allowed to repair the instrument and dispose of the i...

Страница 14: ...nsportation the instrument may be shaken tilted or lifted Before each transportation the instrument must be drained including piping paraffin cylinder and reagent bottle Otherwise the instrument may b...

Страница 15: ...long time do not leave any tissue in the processing cylinder to prevent the tissue from drying out 2 2 6 Warning Cleaning and maintenance Before each maintenance or cleaning the instrument shall be TU...

Страница 16: ...ime and system operation condition and predicts the failure in advance 2 3 2 Temperature Monitoring Temperature control adopts multi point acquisition and temperature protection switch for temperature...

Страница 17: ...cylinder a paraffin cylinder an airway module and a man machine interactive system etc 1 Dehydration cylinder 2 Tissue sample basket 3 Electronic lock and manual opening knob for dehydration cylinder...

Страница 18: ...validated dehydration processes for small tissues standard tissues and standard tissues overnight and are not editable Three rinse processes are included namely fast rinse standard rinse and warm rins...

Страница 19: ...the dehydration process thus reducing cross contamination and loss of reagents The inner wall of the cylinder lid is also coated with a Teflon plating layer which serves to reduce the residual adhesi...

Страница 20: ...me time the rotary valve has a thermal insulation design to avoid the risk of clogging of the valve hole Each dehydration cylinder can hold up to 300 standard cassettes using 2 sample baskets Each bas...

Страница 21: ...Dakewe Shenzhen Medical Equipment Co Ltd 17 necessary...

Страница 22: ...weight without packaging Approx 180kg Weight with packaging Approx 249kg Dehydration cylinder Parameter Capacity Up to 300 cassettes Temperature paraffin 50 C 65 C Temperature dehydration reagent Ambi...

Страница 23: ...ers of seal rings for tissue processing cylinders Number of cycles days Management parameters of seal rings for paraffin cylinders Number of cycles days Management parameters of seal rings for reagent...

Страница 24: ...65 C Alcohol for rinse 60 C 3 4 Compatible Reagents The following reagents can be used in this equipment Reagent group Reagent Fixed group Formalin buffered or non buffered Formalin substitute Dehydr...

Страница 25: ...nd there must be no open flame The installation site must have electrostatic discharge protection Do not use the instrument in an indoor environment with explosive hazards In order to ensure the norma...

Страница 26: ...site C Remove the top cover 1 Remove the 6 fastening screws of the top cover with No 14 metric or adjustable open end wrench and remove the cover and top foam by two persons D Remove the four side pro...

Страница 27: ...transport the instrument After disassembling the wooden strips fixing the casters of the tissue processor release the brake of the casters of the dehydrator The equipment casters are very easy to move...

Страница 28: ...3 Remove the monitor s strut member The strut member is divided into three sections namely upper segmental plate Figure 10 3 intermediate segmental plate Figure 10 4 and lower segmental plate Figure...

Страница 29: ...ould still avoid any reagents splashing on the touch screen if any please wipe it immediately Figure 4 4 2 Color LCD touch screen 4 3 3 Dehydration Cylinder Turn on or off the dehydration cylinder If...

Страница 30: ...ue processing cylinder head is controlled by an electronic lock When locking do not put your fingers on the cylinder head area to prevent pinching During the working process of the equipment the tempe...

Страница 31: ...of reagents in the process of dehydration An dust proof net is installed outside the concentration detection sensor Figure 12 4 to prevent human error contact of the sensor probe and make it invalid T...

Страница 32: ...e active carbon filter Figure 13 2 inside Hook the strap Figure 13 3 on the front of the filter with fingers and pull the active carbon filter out vertically When inserting the active carbon filter fo...

Страница 33: ...o an exhaust emission device the active carbon filter equipped for HP300 Plus must still be installed 4 3 6 Marble Workbench An integrated marble workbench is mounted on the top of the HP300 Plus The...

Страница 34: ...ss HP300 Plus is also equipped with one large paraffin cylinder with maximum paraffin storage volume of 5 6L Large paraffin cylinders are generally used for paraffin filling and paraffin backup The pa...

Страница 35: ...to be processed fill paraffin to the corresponding scale line Pay attention to the paraffin case door hinge Do not place your fingers in the position shown by the figure above Figure 17 3 Do not force...

Страница 36: ...to two layers and placed in the reagent compartment below the paraffin case Figure 20 1 Each reagent bottle is equipped with an RFID tag to identify and match the station and reagent bottle Figure 21...

Страница 37: ...rtment When you hear the shrapnel action sound of click you can observe the blue light transmitted from the rear of the bottle At this point the software will show that the reagent bottle is in a colo...

Страница 38: ...r pulls out the reagent bottle to replace the reagent the reagent is easy to overflow by shaking and thus remains on the reagent bin board The reagents on the board will flow into the waste liquid col...

Страница 39: ...nt there will be some situations that require the user s attention or decision The simplest case is some confirmation operations to continue the dehydration program In addition in the continuous monit...

Страница 40: ...is different from the voltage set by the factory it may cause serious damage Connect the main power cord Figure 22 2 to the power socket Use jumper wire connection Figure 22 3 to connect the jumper i...

Страница 41: ...r the set time 2 Automatic screen rest time The system will automatically enter the power saving mode after the set time without operation 3 Reminder time for disembarkation After the program is compl...

Страница 42: ...ing function is turned on by default Turning on this function will keep the tissue cylinder dry and odorless Turning off this function will reduce the cleaning procedure time by 15 minutes 2 Function...

Страница 43: ...in turn to pop up the soft keyboard enter the set password The password should be 1 20 digits 4 Click the Next button to complete the creation of an administrator account a Enter your user name b Succ...

Страница 44: ...strument you need to perform the following steps 1 In the main interface click the Menu Settings Software Settings button in turn to enter the Software Settings module a Menu setting related b Softwar...

Страница 45: ...for the instrument to cool down Before moving the instrument make sure that there is no paraffin in the wax bath or waste wax collection tray and the wax boxes and activated carbon doors are closed to...

Страница 46: ...inistrator user and manufacturer user For user level switching refer to 5 1 Access Level 3 The currently logged in user name and its own authority icon there are three authority levels ordinary user a...

Страница 47: ...anel shows the progress of dehydration including the expected end time current step remaining time of the current step etc 3 Tab panel Figure 27 3 There are three buttons on the tab panel Click the me...

Страница 48: ...is the default user level after logging in to the instrument Common user is able to use conventional processor functions such as running programs viewing results setting the reagent status to null or...

Страница 49: ...t and select the account to log in from the list Click the input field behind the password icon to pop up the soft keyboard and then click or to close the soft keyboard after entering the password Cli...

Страница 50: ...the next menu Rinse program running icon Click to enter the rinse program list interface You can select any rinse program for execution The processor lid can be opened after clicking the Open Lid butt...

Страница 51: ...Touch the central area of any submenu to display the next submenu button that can be manipulated 6 1 Basic Function Click Basic Function button to enter the basic function interface Figure 33 1 You c...

Страница 52: ...creation viewing deletion copying in this interface Figure 34 6 1 1 1 Create the program Click Create button Figure 34 1 The system will automatically create an unnamed blank program form Figure 35 Fi...

Страница 53: ...et the time required for the reagents to soak in each step Figure 36 3 Touch the pop up soft keyboard to set the desired temperature for each step Figure 36 4 Click the triangle on the right side of t...

Страница 54: ...the editing interface of this step line Figure 37 3 delete step Touch to select the step line to be deleted Click the Delete Step button The system will directly delete the selected step line Check th...

Страница 55: ...8 2 button to pop up the deletion dialog box Click OK Figure 38 3 to confirm deletion Click Cancel to cancel the delete operation 6 1 1 3 View modify the program In the program management interface to...

Страница 56: ...Rinse Program Click Rinse Program in the basic function interface to enter the rinse program interface This interface allows you to view the default rinse program in the processor This interface only...

Страница 57: ...running programs viewing results setting the reagent status to empty or full etc are available to common users The functions that are unavailable to the common users will not be displayed in the func...

Страница 58: ...s after the soft keyboard pops up Figure 43 2 Set permissions afterwards Click the OK button to complete the addition of new users The added users will be displayed on the left 6 1 3 3 Edit user Touch...

Страница 59: ...Cancel to stop modifying the user password 6 1 3 5 Delete users When the administrator account selects other user accounts At this time the Delete User button appears click Delete User the Delete User...

Страница 60: ...p Figure 47 1 Touch to select the reagent name to be replaced in the list to complete the reagent modification of the reagent site Figure 47 Figure 46 It is not allowed to modify the site reagents in...

Страница 61: ...agents in this interface 6 1 5 1 Add reagent Click the Add Reagent button Figure 48 1 The new reagent setting Figure 49 1 will display on the right Touch the reagent name to pop up the soft keyboard i...

Страница 62: ...delete the selected reagent Click Cancel to stop deleting the reagent 6 1 6 Screen Cleaning Click the Clean Screen button to enter the cleaning screen interface which provides the function of avoidin...

Страница 63: ...ic settings for system language sound display brightness etc 6 2 1 1 Language setting Touch the language setting column to pop up the drop down box Select the language then click the Apply button Figu...

Страница 64: ...h a finger to increase the brightness and swipe to the left to decrease the brightness Touch the automatic time locking column Select the time in the drop down box to complete the system locking time...

Страница 65: ...function modes 1 Drain out old liquid Step 1 pumping liquid from the reagent bottle to the retort Step 2 drain liquid from the retort to the waste liquid tank Step 3 clean the draining pipe blow air i...

Страница 66: ...time of the program s dehydration program is 10 hours the device will automatically start the dehydration program at 22 o clock and end the program at 8 o clock the next morning Stirring time Figure 5...

Страница 67: ...Dakewe Shenzhen Medical Equipment Co Ltd 63 Figure 56...

Страница 68: ...in the interface Click Apply when finished 6 2 3 RFID Setting Menu Set related interface click RFID Settings button to enter the RFID Settings interface enable RFID function and reagent bottle identif...

Страница 69: ...wind speed and duration Every day after the cleaning process is finished the paraffin purification process will be automatically run according to the set value only once You can also set the mode to...

Страница 70: ...ng and starting that is the paraffin purification will be terminated After the program is finished or paraffin wax is melted the fan will automatically resume operation Before running the fan module c...

Страница 71: ...heck to enable the quality control function Figure 59 1 The system provides the statistical information on site and reagent replacement records Figure 59 2 Figure 59 Figure 58 Check the automatic reag...

Страница 72: ...or and replacement time Figure 60 2 6 3 1 2 Threshold setting Touch the Threshold Setting column Figure 61 1 Touch to select any reagent Then click the Threshold Setting button Figure 61 2 The thresho...

Страница 73: ...ge days usage count replacement date and operators Figure 62 2 6 3 1 4 RFID function Reagent sealing function is closed by default which needs to use the highest permission account to open in Advanced...

Страница 74: ...rical details interface Figure 63 It is able to view the statistical information such as start time and end time of the historical running program in the interface Touch to select any program Click th...

Страница 75: ...atistical information such as service life frequency of usage etc of the automatic tissue processor s main components 6 3 4 Data Management Click to enter the data management interface The system allo...

Страница 76: ...iquid level 1 and liquid level 2 Users cannot click any button on the interface to perform other operations in the process of pumping and draining liquid Paraffin is pumped and drained to detect wheth...

Страница 77: ...o the instrument Make sure to place the reagent bottle in the correct position according to the reagent bottle layout on the display screen 1 Remove the reagent bottle from the reagent case Unscrew th...

Страница 78: ...ck in the upper right corner to exit Check the reagent liquid level in the reagent bottle on a flat surface Be sure to keep the line of sight at the same height as the reagent liquid level to ensure t...

Страница 79: ...ing The liquid levels must be between these two marks and can be filled with paraffin particles paraffin blocks or liquid paraffin Set the paraffin melting parameters Click the temperature icon Figure...

Страница 80: ...necessary personal protective equipment Dispose of the used paraffin into a large container and refill the paraffin cylinder The marks of the highest and lowest filling liquid levels are located on th...

Страница 81: ...el and the system will not calculate the paraffin melting time Figure 71 It is recommended to refill the paraffin cylinder one by one If the paraffin cylinder is refilled with paraffin with different...

Страница 82: ...e automatic liquid change function 3 Return to the main interface click the label of reagent bottle that needs to be replaced on the main interface enter the next level and click reagent automatic rot...

Страница 83: ...aximum liquid level nor does it fall below the minimum liquid level Insufficient reagents paraffin may cause the sample to dry out because it is not sufficiently submerged Check whether the reagent bo...

Страница 84: ...ick the Select Program button Figure 72 1 Select a program in the program list interface The selected program name and icon are highlighted Figure 72 2 Check again whether the highlighted program is t...

Страница 85: ...Dakewe Shenzhen Medical Equipment Co Ltd 81 Select the number of tissue sample baskets Figure 74 Figure73 73ure 73 Figure 74...

Страница 86: ...er the number of cassettes 0 300 After completion click Next Figure 75 Figure 75 When the number of cassettes is 1 to 150 the number of baskets can be arbitrarily selected when the number of cassettes...

Страница 87: ...Or after checking Delay Start click the Edit Appointment Time button Figure 76 2 to enter the appointment setting interface of the program end time Figure 76 3 After completing the settings in order c...

Страница 88: ...e 77 1 to enter the program shortcut program setting interface All the dehydration programs stored in the system are displayed in the list The user clicks to select any program Figure 77 2 Click Set a...

Страница 89: ...ick the Run button afterwards The system will calculate the time that needs to be delayed The staining program is automatically started when the time arrives During the program operation do not open t...

Страница 90: ...dicating that the dehydration cylinder lid is open and the sample baskets can be taken out The electronic lock has been automatically turned on After the tissue sample basket is taken out and the dehy...

Страница 91: ...tandard rinse can be used for dehydration Xylene for rinse and alcohol for rinse are recommended to be replaced after 5 times of rinse otherwise it will affect the dehydration effect HP300 Plus includ...

Страница 92: ...heric pressure 3 Positive and negative pressure drying 6 70 Vacuum positive pressure 9 1 1 Rinse Process Step Operation 1 Before running rinse confirm that all tissue samples inside the dehydration cy...

Страница 93: ...number of uses of the cleaning reagent has reached the use threshold the reagent expired mark will be displayed on the reagent bottle and the user needs to replace the cleaning reagent Table 4 Usage T...

Страница 94: ...Teflon coating from being destroyed Use a piece of lint free cloth to wipe the surface of the seal ring on the inner wall of the cylinder lid During wiping avoid causing scratches and damages to the s...

Страница 95: ...ide and then be inserted back into the original place every week Waste liquid evacuation is prompted in the software It is necessary to promptly empty the waste liquid collection bottle after the prom...

Страница 96: ...92 Dakewe Shenzhen Medical Equipment Co Ltd...

Страница 97: ...ng effect of the seal ring and the smoothness of plugging and unplugging After cleaning refill the reagent bottle Screw the bottle cap Insert the bottles in the correct order into the reagent compartm...

Страница 98: ...ly inserted into the connector 7 Clean the waste paraffin collection tray 8 Remove the paraffin residuals on the internal surface of the paraffin cylinder Check the paraffin cylinder filter 9 Check an...

Страница 99: ...ing When HP300 Plus fails take the following steps for processing Read error messages Operate according to the description of the message prompt Check the running log for fault message history Perform...

Страница 100: ...case of power failure the dehydration cylinder lid shall be opened to remove tissues through manual unlocking mechanism If power recovered the system will reheat according to previous settings and ex...

Страница 101: ...ecial warranty services contact your local sales representative or the dealer who sells the instrument 11 2 Technical Service Information If technical service or component replacement is required cont...

Страница 102: ...irements specified in GB T 26572 The toxic and harmful substances or elements in the product within the above mentioned period of time from the date of production shall be complied with in accordance...

Страница 103: ...used Warning HP300 Plus Automatic Tissue Processor is designed and and tested according to Class A equipment in CISPR 11 In the home environment the equipment may cause radio interference so that prot...

Страница 104: ...rge IEC61000 4 5 Line to ground 2kV Line to line 1kV B Radio frequency transmission IEC61000 4 6 Power cord 3V 150kHz 80MHz 80 AM A Power frequency magnetic field IEC61000 4 8 3A m 50 60Hz A Voltage s...

Страница 105: ...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...

Страница 106: ...102 Dakewe Shenzhen Medical Equipment Co Ltd Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment...

Страница 107: ...ddress Floor 5 Building B No 2 Luhui Road Jinsha Community Kengzi Street Pingshan District Shenzhen China Tel 0755 26413421 Fax 0755 27383156 Customer Service 400 6304366 Website http www dakewemedica...

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