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DGH DGH 55B, Operator'S Manual

The DGH DGH 55B Operator's Manual is a comprehensive and essential guide for users of this exceptional product. This manual provides detailed instructions and valuable insights to maximize your experience. Download this manual for free from our website, manualshive.com, to unlock the full potential of your DGH DGH 55B.

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Page 3 of 87 

 

DGH 55B-INS-OMENG Rev: 3 

 
 

Table of Contents 

 

TABLE OF CONTENTS ............................................................................................................................................ 3

 

1.

 

INTRODUCTION .............................................................................................................................................. 6

 

1.1

 

G

ENERAL 

D

EVICE 

D

ESCRIPTION

 ...................................................................................................................... 6

 

1.2

 

D

EVICE 

C

LASSIFICATION

 ................................................................................................................................. 6

 

1.3

 

I

NDICATIONS 

F

OR 

U

SE

 ..................................................................................................................................... 6

 

2.

 

DESCRIPTION OF SYMBOLS ....................................................................................................................... 7

 

3.

 

GENERAL CAUTIONS AND WARNINGS, PRESCRIPTION DEVICE STATEMENT AND 

 

OPERATOR QUALIFICATIONS ................................................................................................................... 8

 

3.1

 

G

ENERAL 

C

AUTIONS AND 

W

ARNINGS

 .............................................................................................................. 8

 

3.2

 

P

RESCRIPTION 

D

EVICE 

S

TATEMENT

 ................................................................................................................. 8

 

3.3

 

O

PERATOR 

Q

UALIFICATIONS

............................................................................................................................ 8

 

4.

 

USE OF ULTRASOUND IN OPHTHALMIC MEASUREMENT ............................................................... 9

 

4.1

 

I

NTRODUCTION 

T

O 

U

LTRASOUND

 .................................................................................................................... 9

 

4.2

 

U

SING 

U

LTRASOUND 

T

O 

A

SCERTAIN 

C

ORRECT 

P

ROBE 

A

LIGNMENT

 ............................................................... 9

 

4.3

 

U

LTRASONIC 

M

EASUREMENT

 ........................................................................................................................ 10

 

4.4

 

P

ROPER 

A

PPLANATION FOR 

T

AKING 

A

 

M

EASUREMENT

 ................................................................................. 11

 

5.

 

ULTRASONIC EXPOSURE AND INTENSITIES ...................................................................................... 12

 

5.1

 

T

ISSUE 

E

XPOSURE 

T

O 

U

LTRASOUND 

E

NERGY

 ............................................................................................... 12

 

5.2

 

U

LTRASONIC 

I

NTENSITIES

 .............................................................................................................................. 12

 

5.3

 

B

IOMETRIC 

M

EASUREMENT 

C

APABILITIES

 .................................................................................................... 13

 

6.

 

PHYSICAL DESCRIPTION .......................................................................................................................... 14

 

6.1

 

F

RONT 

V

IEW

 .................................................................................................................................................. 14

 

6.2

 

B

ACK 

V

IEW

 .................................................................................................................................................... 16

 

6.3

 

P

ROBE

 ............................................................................................................................................................ 17

 

6.4

 

C

ALIBRATION 

V

ERIFICATION 

B

OX 

(C

AL

B

OX

) ............................................................................................... 18

 

7.

 

PROBE USE AND INDICATORS ................................................................................................................. 19

 

7.1

 

I

NSERTING AND 

R

EMOVING THE PROBE

 .......................................................................................................... 19

 

7.2

 

H

OLDING THE 

D

EVICE

 .................................................................................................................................... 20

 

7.3

 

‘C

HECK 

P

ROBE

’

 

E

RROR 

M

ESSAGE

 ................................................................................................................. 21

 

7.4

 

‘P

LUG 

I

N 

P

ROBE

’

 

E

RROR 

M

ESSAGE

 ............................................................................................................... 21

 

7.5

 

‘PQF

 

F

AILED

’

 

E

RROR 

M

ESSAGE

 .................................................................................................................... 21

 

8.

 

VERIFYING PACHMATE 2 CALIBRATION ............................................................................................ 22

 

8.1

 

P

ROCEDURE 

F

OR 

V

ERIFYING 

C

ALIBRATION

 ................................................................................................... 22

 

9.

 

POWER MODES ............................................................................................................................................. 24

 

9.1

 

M

EASUREMENT 

M

ODE

 ................................................................................................................................... 24

 

9.2

 

S

TANDBY 

M

ODE

 ............................................................................................................................................ 24

 

Summary of Contents for DGH 55B

Page 1: ...0 345 8570 EC REP EMERGO EUROPE DGH TECHNOLOGY INC 110 SUMMIT DRIVE SUITE B EXTON PA 19341 USA 610 594 9100 Molenstraat15 2513 BH The Hague The Netherlands Phone 31 70 345 8570 EC REP EMERGO EUROPE DGH TECHNOLOGY INC 110 SUMMIT DRIVE SUITE B EXTON PA 19341 USA 610 594 9100 Molenstraat15 2513 BH The Hague The Netherlands Phone 31 70 345 8570 EC REP EMERGO EUROPE DGH TECHNOLOGY INC 110 SUMMIT DRIVE ...

Page 2: ...Page 2 of 87 DGH 55B INS OMENG Rev 3 This page intentionally left blank ...

Page 3: ...ORRECT PROBE ALIGNMENT 9 4 3 ULTRASONIC MEASUREMENT 10 4 4 PROPER APPLANATION FOR TAKING A MEASUREMENT 11 5 ULTRASONIC EXPOSURE AND INTENSITIES 12 5 1 TISSUE EXPOSURE TO ULTRASOUND ENERGY 12 5 2 ULTRASONIC INTENSITIES 12 5 3 BIOMETRIC MEASUREMENT CAPABILITIES 13 6 PHYSICAL DESCRIPTION 14 6 1 FRONT VIEW 14 6 2 BACK VIEW 16 6 3 PROBE 17 6 4 CALIBRATION VERIFICATION BOX CALBOX 18 7 PROBE USE AND INDI...

Page 4: ... PARAMETERS FOR MAPPING MEASUREMENT MODE 48 13 4 GENERAL DEVICE PARAMETERS 49 13 5 BLUETOOTH PARAMETERS 51 14 CONFIGURING BLUETOOTH CONNECTIONS 53 14 1 ENABLING BLUETOOTH 53 14 2 PAIRING WITH A BLUETOOTH ENABLED PRINTER 53 14 3 SENDING MEASUREMENTS TO A BLUETOOTH ENABLED WIRELESS PRINTER 55 14 4 PAIRING WITH A BLUETOOTH ENABLED PC 56 14 5 ADDING COM PORTS 59 14 6 SENDING AND RECEIVING INFORMATION ...

Page 5: ...CONDITIONS 77 17 4 OPERATING CONDITIONS 77 18 TROUBLESHOOTING GUIDE 78 19 SERVICE 79 19 1 REPAIRS AND CUSTOMER SUPPORT 79 19 2 VIEWING MODEL AND SERIAL NUMBER 79 19 3 WARRANTY 80 20 MANUFACTURED BY DGH TECHNOLOGY INC 80 21 AUTHORIZED EUROPEAN REPRESENTATIVE 81 22 REGULATORY COMPLIANCE 81 22 1 EMI EMC COMPLIANCE 81 22 2 WIRELESS RADIO MODULE REGULATORY COMPLIANCE 83 ...

Page 6: ...MHz damped to 13MHz through the eye and reflected pulses echos are received back to the transducer and are converted to voltage pulses The first echo to be received comes from the anterior corneal surface If an echo spike from the anterior corneal surface is received within an anticipated time window the DGH 55B then prepares to receive an echo spike from the posterior corneal surface Only anterio...

Page 7: ... electronic devices must not be disposed of as normal domestic refuse In order to prevent environmental risks or endangerments by non professional disposal the disposal of this product including any accessories must comply with valid practices as outlined in Directives 2002 96 EC 2003 108 EC and 2002 95 EC and local regulations All electronic components and systems should be returned to Original M...

Page 8: ...fied service personnel 3 2 Prescription Device Statement WARNING The DGH 55B Pachmate 2 is a prescription device and is only to be used by or under the supervision of a licensed physician 3 3 Operator Qualifications This DGH 55B is intended to be used by trained medical professionals The medical professional operating the DGH 55B must have a general knowledge of the use of ultrasonic medical devic...

Page 9: ...ween surfaces in the eye NOTE Ultrasound cannot travel through air because air is not dense enough for the high frequency waves to propagate Ultrasonic measurements must therefore be performed by direct contact or through a denser medium such as water 4 2 Using Ultrasound To Ascertain Correct Probe Alignment Sound travels in straight lines so the direction of reflected sound is based solely on its...

Page 10: ...ubstances containing large amounts of water conduct ultrasound very well air does not conduct ultrasound Using the relationship between the density of a material and the speed of sound ophthalmic pachymeters obtain distances in the eye by performing a two step process First a pulse of sound is timed as it travels through the cornea reflects off the back of the cornea and returns to the transducer ...

Page 11: ... tip to the cornea 1 and 2 CORRECT The probe IS perpendicular to the corneal surface 3 and 4 INCORRECT The probe IS NOT perpendicular to the corneal surface Fig 4 4 1 Correct and Incorrect Applanation While in Measurement Mode the Pachmate 4 will automatically take a measurement whenever the tip of the probe is properly applanated to the cornea WARNING Moving or realigning the probe tip while it i...

Page 12: ...or Thus the values below are the values to be expected for a typical transducer Since the DGH 55B Pachmate 2 is not capable of exceeding either a TI of 1 0 or an MI of 1 0 in any operating mode the output of the system is reported as shown in the Table below The appropriate Thermal Index is the Thermal Index for Soft Tissue TIS for the non scanning case with a beam aperture of less than 1 0 cm Out...

Page 13: ...llimeter The nominal piezoceramic crystal frequency of these transducers is 20 MHz The actual frequency of a particular transducer may vary from this value The tissue calculations above were done with the measured frequency of the transducer used for the tests 5 3 Biometric Measurement Capabilities The following table shows the measurement range for the DGH 55B Ultrasonic Pachymeter Pachmate 2 Mea...

Page 14: ... only appear on the front panel of the unit if the device has the optional Bluetooth module installed 4 DEL Key Used to erase a single measurement from a group of measurements Also used in conjunction with the PWR key to enter the CalBox mode 5 CFG Key Used to enter and exit the configuration mode Also used to display the unit model number serial number software version and option number when the ...

Page 15: ... take measurements of the LEFT eye 9 Keys Used to review measurements or to program options and numerical values presented on the display 10 OD Key Press key to review or take measurements of the RIGHT eye Also used while in the configuration menu to confirm some device parameters 11 PWR Key Pressing this key turns the Pachmate 2 on When the Pachmate 2 is on pressing and holding this key turns the...

Page 16: ...alignment The unit model number and serial number are also located on the label inside the battery compartment The note Contains Transmitter Module FCC ID T7VEBMU IC 216QEBMU will appear on the battery compartment label in devices that contain a Bluetooth wireless module 2 Model Number Location of model number used to identify the unit 3 Device Labels Refer to Section 2 for descriptions of device ...

Page 17: ...Tip The portion of the probe energized when taking a measurement 2 Transducer Housing Contains the transducer and is engraved with a probe serial number 3 Probe Connector The probe connector plugs into the Pachmate 2 unit See section 7 1 for instructions on proper connection and disconnection of probe ...

Page 18: ...ic Calibration Verification Box CalBox is used to simulate the thickness of the cornea Instructions for using the CalBox are given in section 4 and they are also printed on the CalBox label WARNING Calibration verification should be performed daily before using the device Fig 6 4 1 The DGH 55B Pachmate 2 Electronic CalBox ...

Page 19: ...essential for collecting accurate measurements The operator must ensure that the probe is properly cleaned and connected so that the device can perform a probe self test The Pachmate 2 automatically performs a self test to check the functionality of the probe This test is done every time the device is put into Measurement Mode Typically the operator will be unaware that a self test is occurring ho...

Page 20: ...igned to go together WITHOUT twisting When inserting or removing the probe slide the connectors together without twisting 7 2 Holding the Device While handling the device try to avoid contact with the probe tip clear plastic cone so as to avoid contamination Touching the probe tip with ungloved hands may leave a residue that will cause the device to return an error message when self testing See se...

Page 21: ...en 1 the detachable probe is not mated or is improperly mated to the unit or 2 the probe is defective If the probe is found to be defective remove defective probe by holding the probe connector and gently pulling straight out of the unit WARNING Do not twist probe as this could damage connectors Properly align the probe connector and gently push in until properly seated 7 5 PQF Failed Error Messag...

Page 22: ...hmate 2 turned off disconnect the probe by holding the connector and gently pulling straight out of the unit Caution Do not twist probe as this could damage connectors 8 1 2 Connect the CalBox to the Pachmate 2 by inserting the CalBox lead into the probe connector 8 1 3 Enter the CalBox mode by pressing and holding the Pachmate 2 s DEL key and then press the PWR key 8 1 4 Press and hold the CalBox...

Page 23: ...595 µm 605 µm Measurement 6 700 µm pulse Acceptable Result 695 µm 705 µm Measurement 7 800 µm pulse Acceptable Result 795 µm 805 µm Measurement 8 900 µm pulse Acceptable Result 895 µm 905 µm Measurement 9 1000 µm pulse Acceptable Result 995 µm 1005 µm WARNING If ANY of the calibration measurements are outside of the acceptable result tolerance contact DGH Technology Inc 8 1 6 When all measurements...

Page 24: ...play When Measurement Mode is set to Mapping the device will display 9 2 Standby Mode This is when the device is not energizing the probe The unit automatically goes into Standby Mode if there has been no attempt at measurement for one minute The device will not be able to detect corneal contact in Standby Mode Standby Mode is indicated by a beep and flashing cursor in the upper left hand corner o...

Page 25: ...measurements the device will show an empty measurement screen If there are active measurements the Pachmate 2 will display Press the key to clear all measurements Press the key to retrieve all measurements After exiting Sleep Mode the device will return to Measurement Mode 9 4 Powering Down The unit is powered down by pressing and holding the PWR key The device will emit a beep and turn off NOTE I...

Page 26: ...nt Mode is indicated by a blank space on the lower left hand side of the screen Once the user completes taking measurements for both the right and left eye the measurements must be cleared before a new measurement group can be initiated The device can only remember a single patient s measurements while operating Therefore it is necessary to either write down or export the measurements NOTE In Sing...

Page 27: ...Page 27 of 87 DGH 55B INS OMENG Rev 3 Fig 10 1 1 Single Patient Mode ...

Page 28: ...he memory is capable of storing information for 20 patients The user selects a number P01 P20 and takes measurements for the right and left eye When measurement is complete the user presses the CFG key and all results are recorded and can be retrieved at a later time The user can also use the DGH Connect Software See section 11 to enter patient identification information before taking measurements...

Page 29: ...Page 29 of 87 DGH 55B INS OMENG Rev 3 Fig 10 2 1 Multi Patient Mode ...

Page 30: ... indicated by a number P01 P20 on the bottom left hand side of the screen If the patient location is empty there will be a No Data message If the patient location contains recorded measurements there will be a Meas Only message If the location contains patient ID information See 15 5 for instruction on entering patient ID the device will show the patient name By pressing the OD or OS key while the...

Page 31: ...rmation to the specified location in Non Volatile Memory 10 3 6 To select a different patient location or Single Patient Mode press the or key to scroll through the Select Patient menu Press the CFG key again to make the selection 10 4 Adding Patient Identification Information The Pachmate 2 will store a single patient s name ID number date of birth and gender in each patient location Patient ID i...

Page 32: ...oaded patient o Selecting OD Current Meas clears all measurements of the right eye for the currently loaded patient o Selecting OS Current Meas clears all measurements of the left eye for the currently loaded patient o Selecting Nothing Exit exits the menu without deleting anything The other clearing options affect stored patient information or system configuration o Selecting All Patients clears ...

Page 33: ...option is Continuous Averaging In this mode the device takes 25 corneal measurements in rapid succession at a single location and generates an average from those measurements The device allows the user to program how many measurements are taken from 1 to 25 as well as the period of time between consecutive measurements default is 50msec While in Continuous Averaging Measurement Mode the screen wil...

Page 34: ...r the actual measurement and the calculated biased measurement With Mapping Measurement Mode enabled the Pachmate 2 can be programmed to record from 1 to 33 unique measurement positions The illustration below shows 33 potential measurement points Fig 11 2 1 Potential Mapping Points Using multiple measurement points allows the user to map the thicknesses of the cornea at various locations however t...

Page 35: ...Scroll until the Operational Mode menu is displayed 11 3 3 Pressing the or key will switch between Continuous Averaging or Mapping modes 11 3 4 Press the CFG key when the preferred mode is displayed If changes have been made the device will display the Save New Config message 11 3 5 Press the key to select Yes to save the configuration If there is data that is cleared the device will display the A...

Page 36: ...12 1 1 Rotate the probe into the fully open position It is recommended that the probe be rotated back into the cavity for protection when transporting the Pachmate 2 or when the unit is not being used WARNING When rotating the probe into the open position do not twist the probe itself this can damage the connectors 12 1 2 Turn on the unit 12 1 3 The Pachmate 2 performs an internal self test functi...

Page 37: ...rational Mode menu See Section 11 3 12 2 4 Select a memory location to associate measurements with or select Single Patient Mode See Sections 10 1 and 10 2 12 2 5 Select the number of measurements to be obtained default is 25 measurements See Section 13 2 2 12 2 6 Press the CFG key to exit the Configuration Menu If changes have been made the Pachmate 2 will prompt for confirmation of the configura...

Page 38: ...e the device has collected the required number of measurements the device will emit two long beeps and display the Measurement Group Completed message 12 2 13 The device will display the measurement average and standard deviation of the eye measured To scroll through individual measurements press the or key If Auto Switching is enabled See 13 2 1 the device will only display the results for a few ...

Page 39: ...saved to memory 12 2 17 To clear all measurements for one or both eyes press the CLR key The user will be prompted with the What To Clear menu The following selections affect the patient currently being measured o Selecting All Current Meas clears all measurements of both the left and right eye for the currently loaded patient o Selecting OD Current Meas clears all measurements of the right eye fo...

Page 40: ... Mode is selected in the Operational Mode menu See Section 11 3 12 3 4 Select a memory location to associate measurements with or select Single Patient Mode See Sections 10 1 and 10 2 12 3 5 Select the number of positions to be measured default is 33 measurements See Section 13 3 1 12 3 6 Press the CFG key to exit the Configuration Menu If changes have been made the Pachmate 2 will prompt for conf...

Page 41: ...ng black cursor is not shown in the upper left hand corner 12 3 11 Gently position the probe tip on the cornea as described in section 4 4 The Pachmate 2 will automatically take a single measurement when the probe is properly applanated For each successful measurement taken the device will emit a quick beep If the device is not able to obtain a measurement within 3 seconds the device will emit a l...

Page 42: ...ns until all necessary measurements have been taken 12 3 15 The device DOES NOT indicate when all measurements have been taken instead it will go back to the measurement for position number 1 To scroll through each measurement press the or key The device will list the position number and list the thickness measurement below 12 3 16 If a questionable measurement is found during review the operator ...

Page 43: ...n or system configuration o Selecting All Patients clears all identifying information and all measurements for all patients Bluetooth option only o Selecting Paired Devices clears all paired devices from the device memory Bluetooth option only 12 4 Viewing Date and Time The Pachmate 2 can display the time and date on the screen to assist the operator in recording when measurements are taken 12 4 1...

Page 44: ... procedure explains how to access the configuration menu and modify the default parameters 13 1 Entering and Navigating the Configuration Menu 13 1 1 To enter the Configuration Menu press the CFG Key The screen will display 13 1 2 While in the Configuration Menu each time that the ENT key is pressed the device will display the next editable parameter When the last parameter is reached and the ENT ...

Page 45: ...overed when scanned by other Bluetooth enabled devices Scanning When the OD key is pressed the device is actively scanning for other Bluetooth enabled devices Only available if Bluetooth is enabled Printer Config Press or key to switch between printer config options Then press the OD key to select what to include Add Patient When Y Yes is displayed patient information will be included on the print...

Page 46: ... 2 0 sec Press or key to change the value 1 0 to 9 5 Period of time in seconds after a poor applanation occurs before the unit will automatically advance to the next measurement position Always Available Delay to Standby 1 0 min Press or key to change the value 0 5 to 9 5 Period of time in minutes that the device will wait before automatically switching to Standby Mode Always Available Battery Typ...

Page 47: ...urement group is complete Press the or key to change the configuration 13 2 2 Numb of Meas default 25 is the number of measurements that the unit will use to calculate the measurement average and standard deviation of a measurement point in Continuous Averaging Measurement Mode It can be adjusted from 1 to 25 Press the or key to change the value WARNING All measurements in the device including tho...

Page 48: ...sables if the device will display a measurement bias with each measurement taken during Mapping Measurement Mode Press the or key to change the configuration 13 3 3 Amount Of Bias default 100 determines the amount of bias used in calculating the measurement bias in Mapping Measurement Mode This parameter is only available if the device is configured to display measurement bias It can be adjusted f...

Page 49: ...3 1 13 4 1 Delay To Standby default 1 0 min is the amount of time that the device will wait before going into Standby Mode It can be adjusted from 0 5 min to 9 5 min Press the or key to change the value 13 4 2 Battery Type should be selected to match the batteries installed in the device If the device detects that the batteries have been removed a prompt will require the user to set the battery ty...

Page 50: ...ate Format default MMM DD YYY sub menu Press the or key to change the value The date can display as either MMM DD YYYY or DD MMM YYYY Press the OD key to enter the Time Date sub menu While in this sub menu there will be a blinking black cursor Use the OD and OS keys to move the cursor left and right Press the or key to change the value in each field TIME DATE Format Set DATE FORMAT MMM dd yyyy Tim...

Page 51: ...is enabled a logo will appear in the upper left hand corner 13 5 2 Send Meas To determines which device the Pachmate 2 will transmit records to If there are no devices paired with the Pachmate 2 the screen will display None If the Pachmate 2 is paired to one or more devices the screen will display o NAME is the name of the device that will receive the records o A is the list number of the device s...

Page 52: ...tch between Yes and No o If Add Patient is enabled but no patient identifying information is entered blank lines will be printed Add Notes default No determines if the printed measurement report will include an area for the operator s hand written comments Press the OD key to switch between Yes and No Add All Meas default No determines if each measurement taken during Continuous Averaging Mode is ...

Page 53: ... The Pachmate 2 will return to Measurement Mode 14 1 3 An icon will appear in the upper left hand corner to indicate that the Bluetooth module is enabled 14 2 Pairing with a Bluetooth enabled printer The Pachmate 2 can be paired directly to a Bluetooth enabled printer Once paired the operator can print measurements directly from the device without the need for a PC 14 2 1 Turn on the printer and p...

Page 54: ... OD key will cause the Pachmate 2 to attempt to pair with the displayed device 14 2 6 With the desired device displayed select Add by pressing the OD key 14 2 7 The Pachmate 2 will prompt the operator to confirm the device being paired to Use the key to select Yes when prompted 14 2 8 The Pachmate 2 will display a message indicating that it is in the process of pairing It will then prompt the user...

Page 55: ...change 14 2 13 Press the key to select Yes and save the configuration The Pachmate 2 will return to Measurement Mode 14 3 Sending measurements to a Bluetooth enabled wireless printer 14 3 1 Press the CFG key to enter the Configuration Menu and navigate to the Printer Config menu by repeatedly pressing the ENT key 14 3 2 Confirm that the desired fields are set to be included in the printed report S...

Page 56: ...ate 2 will store the printer configuration This allows the user to print from this device directly at any time by pressing and holding the ENT key 14 4 Pairing with a Bluetooth enabled PC The Pachmate 2 can be paired with PCs that are equipped with Bluetooth wireless technology This can be via integrated Bluetooth modules or USB adapters dongles Once the Pachmate 2 is properly paired with the PC t...

Page 57: ... differently 14 4 3 Click the Apply button then the OK button 14 4 4 Turn on the Pachmate 2 and enter the Configuration Menu by pressing the CFG key 14 4 5 Press the ENT key one time to navigate to the Bluetooth parameter Confirm that it is turned On If not press the or key to enable Bluetooth See section 13 5 1 14 4 6 Press the ENT key two times to navigate to Add PC Printer parameter This screen...

Page 58: ...ate 2 displays the passkey press the key to accept 14 4 11 Pairing is now complete Both Windows and the Pachmate 2 will display a message indicating that the process was completed After pairing newer versions of Windows will automatically configure COM Ports This may be indicated by a Driver Software Installation message Older versions of Windows may require the user to manually configure COM Port...

Page 59: ...een paired with the PC See section 14 4 for information on pairing to the PC 14 5 2 Navigate to the Windows Control Panel by going to the Start menu and click on the Control Panel item Find the Bluetooth Settings item and click it to open the dialog box Illustration shows the Windows XP Start Menu Start menu will vary by operating system 14 5 3 In the Bluetooth Settings window there will typically...

Page 60: ...d be automatically selected Confirm that the COM Ports selected match the port numbers that were added in the Bluetooth Settings menu If the Incoming Port is incorrect change it using the drop down menu 14 6 Sending and receiving information via Bluetooth connection to a PC The Pachmate 2 is capable of transmitting measurements and patient information via Bluetooth wireless connections However the...

Page 61: ...f devices paired with the Pachmate 2 Up to 5 devices can be paired at a time o Send indicates that pressing the OD key will cause the Pachmate 2 to transmit measurements to the currently displayed device 14 7 4 With the desired device displayed press the CFG key The Pachmate 2 will prompt for confirmation of the configuration change 14 7 5 Select Yes by pressing the key The Pachmate 2 is now confi...

Page 62: ...6 Press the CFG key to return to Measurement Mode 14 9 Clearing All Paired Bluetooth Devices Occasionally it may be necessary to clear all Bluetooth pairing settings from the Pachmate 2 s memory to allow connection to new devices 14 9 1 Press the CLR key The user will be prompted with the What To Clear menu Use the or key to scroll through the clearing options until Paired Devices is displayed 14 ...

Page 63: ...lay 1024 x 768 resolution Peripherals Mouse or Touchpad Keyboard Bluetooth Radio v2 1 or later Software is compatible with USB Bluetooth adapters dongles for desktop systems 15 1 2 Compatible Operating Systems Microsoft Windows XP Service Pack 3 or higher 32 bit Microsoft Windows Vista Service Pack 2 or higher 32 bit or 64 bit Microsoft Windows 7 32 bit or 64 bit Microsoft Windows 8 8 1 32 bit or ...

Page 64: ...tion directory Confirm the installation directory or set a custom directory 15 2 4 Check the I Agree to the License terms and conditions box on the bottom left hand side of the window The Next button will appear highlighted Click the Next button 15 2 5 The software will list all necessary prerequisite programs 15 2 6 The installer will then install the remaining prerequisites Microsoft System CLR ...

Page 65: ... with the PC and COM Ports must be created before it can communicate with the DGH Connect Software See section 14 4 and 14 5 15 3 1 The Device selection box allows the user to select which DGH Bluetooth enabled device to interact with The Device box will list all devices that are associated with the DGH Connect Software by showing the model number and serial number If no devices are shown in the l...

Page 66: ...eport will be imported to the Report Import Location as an editable DOC file 15 3 4 Report Options default Auto Open enabled control how the report will be processed once it has been saved to the PC One both or none of these options can be selected at the same time If Auto Print is enabled the report s will automatically be sent to the default system printer when imported If Auto Open is enabled t...

Page 67: ... After the device has been paired with the PC it can be selected for use from within the DGH Connect software NOTE The Pachmate 2 must be paired with the PC and COM Ports must be created before it can communicate with the DGH Connect Software See section 14 4 and 14 5 15 4 1 Adding a device can be done by clicking the Add Devices button under the Device selection box or by going to Settings COM Se...

Page 68: ...alog box the user has the option to assign a unique name in the Name field This is to assist the user in distinguishing between units 15 5 Exporting Patient Information to the Pachmate 2 The DGH Connect Software is designed to allow the user to quickly input patient identification information into the Pachmate 2 The following steps explain how to send patient identification information to the Pach...

Page 69: ... the lower right hand corner of the table 15 5 4 The Pachmate 2 will briefly display a message Bluetooth Connected and beep when it has started receiving files It will display Bluetooth Disconnected and beep when all files have been received 15 5 5 After the files have been received press the CFG key on the Pachmate 2 The device will display the Select Patient menu Press the or key to scroll throu...

Page 70: ...ction box choose which device the software is to receive measurements from 15 6 3 Press the Import Measurements button located at the lower right hand corner of the table NOTE If there are no measurements stored in the device the software will display the message No Measurements Exist for Selected Patient s 15 6 4 Once connected the Pachmate 2 will display Bluetooth Connected and will transfer mea...

Page 71: ...pen is enabled the software will open each patient record in its own window If Auto Print is enabled the software will print all patient records from the default system printer 15 6 8 To open the patient reports that have been imported go to the File Open Report The software will open a window that shows all patient records that have been imported 15 6 9 The report will show all measurement and pa...

Page 72: ...to 15 7 5 If you are unsure if the device is pre configured check that the Pachmate 2 is sending the records to the proper device To do this press the CFG key to enter the Configuration Menu and repeatedly press the ENT key to navigate to the Send Meas To menu 15 7 3 Use the and keys to scroll through the saved configurations o NAME is the name of the device that will receive the records o A is th...

Page 73: ...oming COM Port is selected the Pachmate 2 will not be able to initiate measurement transfer To correct this error 15 7 6a Select Settings COM Settings 15 7 6b When the Settings dialog box opens change the port by going to the Incoming Port selection box and choosing a different COM Port from the list The computer will automatically save the new COM Port configuration 15 7 6c If this error occurs a...

Page 74: ...ed the software will open each patient record in its own window If Auto Print is enabled the software will print all patient records from the default system printer 15 7 10 To open the patient reports that have been imported go to the File Open Report The software will open a window that shows all patient records that have been imported 15 7 11 The report will show all measurement and patient info...

Page 75: ... the battery door to gain access to the batteries 16 1 2 Remove the discharged batteries and install new batteries following the orientation shown in the battery compartment 16 1 3 Power up the unit by pressing the PWR key You will be prompted to identify the type of batteries used Select the appropriate type You will receive a message indicating that the time and date must be reset See section 13...

Page 76: ...vicide Solution 10 20 Isopropyl Alcohol and 1 5 Ethylene Glycol Monobutyl Ether Cavicide Wipe 10 20 Isopropyl Alcohol and 1 5 Ethylene Glycol Monobutyl Ether Cidex 2 55 w w Glutaraldehyde Cidex OPA 6 2 by w w Ortho Phthalaldehyde 1 2 benzenedicarboxaldehyde Isopropyl Alcohol 70 v v Isopropyl Alcohol Household Bleach 0 6 w w Sodium Hypochlorite Hydrogen Peroxide 3 w w H2O2 Milton 2 w w Sodium Hypoc...

Page 77: ... for transport or storage of being exposed for a period not exceeding 15 weeks to environmental conditions not outside the following ranges An ambient temperature range of 40 C to 70 C A relative humidity range of 10 to 100 including condensation An atmospheric pressure range of 500 hPa to 1060 hPa 17 4 Operating Conditions The Pachmate 2 should be operated between temperatures of 18 C 64 4 F to 4...

Page 78: ... the top half of the screen 1 Bad battery contact 2 Dead batteries 1 Clean battery contacts 2 Replace batteries See section 16 Slow measurement cycle 1 Dented scratched probe tip 2 Auto Rep Delay configuration 1 Replace probe Contact DGH Technology See section 19 2 Adjust configuration See section 13 2 3 Cannot send files to PC printer 1 Bluetooth not enabled 2 Devices not paired 3 COM settings in...

Page 79: ...with the unit or a probe please contact the Customer Service Department at DGH Technology Inc 110 Summit Drive Suite B Exton PA 19341 Phone 610 594 9100 Fax 610 594 0390 Web www dghkoi com When contacting DGH Technology Inc please make note of the model and serial number for the unit and probe See section 19 2 Service personnel use this to track the status of service calls 19 2 Viewing Model and S...

Page 80: ...replacement or repair of the part that is found to be defective in material and workmanship At the option of DGH said part shall be replaced or repaired free of charge F O B our factory by DGH DGH reserves the right to make changes in the design and material of Equipment without incurring any obligations to incorporate such changes in Equipment already completed on the effective date of any such c...

Page 81: ...ormed according to EN55011 2007 Radiated Emissions The system complied with the radiated emissions requirements throughout the test Tests for radiated and conducted immunity were performed per EN60601 1 2 2007 requirements Tests were performed according to IEC 61000 4 2 2001 Electrostatic Discharge IEC 61000 4 3 2006 RF Susceptibility The system complied with the radiated and conducted immunity re...

Page 82: ... environment specified below The customer or the user of the DGH 55B Pachmate 2 should assure that it is used in such an environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6kV Contact 8kV Air Complies Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative hu...

Page 83: ...Page 83 of 87 DGH 55B INS OMENG Rev 3 22 2 Wireless Radio Module Regulatory Compliance Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 ...

Page 84: ...Page 84 of 87 DGH 55B INS OMENG Rev 3 Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 ...

Page 85: ...Page 85 of 87 DGH 55B INS OMENG Rev 3 Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 ...

Page 86: ...Page 86 of 87 DGH 55B INS OMENG Rev 3 Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 ...

Page 87: ...Page 87 of 87 DGH 55B INS OMENG Rev 3 Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 ...

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