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Only healthcare professionals that are trained and experienced in the use of this medical

device should operate this equipment, see

Intended Users

(page 2).

Equipment is limited to professional use within a professional healthcare environment.

Healthcare professionals should be thoroughly familiar with the instructions for use, handling

characteristics, and the indicated, contraindicated, and intended uses of this equipment.
Contact your Stryker sales representative or customer service for in-service training.

Always inspect the product and all system components for damage upon initial receipt and

before each use. Do not use the product if damage is apparent.

Do not disassemble, modify, or repair this product without the authorization of the

manufacturer. Contact Stryker for service.

Always operate, store, and transport the equipment within the specified environment, see

Environmental Conditions

(page 24).

Do not stare directly into the Surg Reader barcode scanner.

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Take special precautions regarding electromagnetic compatibility (EMC) when using the

Surg System. Install and place this medical electrical equipment into service
according to the EMC information contained in this manual. Portable and mobile
radiofrequency equipment and high frequency (HF) surgical equipment can affect the function
of this medical electrical equipment, see

Electromagnetic Compatibility

(page 25).

Always maintain a minimum separation distance of 6 inches [15 cm] from an in-use pacemaker

and the UHF RFID antenna of the Surg Reader while in use. Failure to comply may
cause interference with the pacemaker.

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Do not allow battery contacts to touch metal objects.

The Sur Cradle and Sur Reader use lithium-ion batteries. To reduce the risk

of fire or burns, do not disassemble, crush, burn, or puncture the batteries. For disposal/
recycle information, see

Disposal/Recycle

(page 21).

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Do not allow any equipment other than a properly prepared reader to enter the sterile field.

Always prepare the reader for sterile use before using the device within the sterile field, see

Preparing the Reader for Sterile Use

(page 16). Failure to comply may cause infection and

result in patient or healthcare staff injury.

Do not contact the patient with the Surg Reader or Surg Reader Cover.

Failure to comply may cause infection and result in patient or healthcare staff injury.

Always clean and disinfect the equipment as indicated upon initial receipt and after before use.

Failure to comply may cause infection and result in patient or healthcare staff injury. For
cleaning and disinfection information, see

Cleaning and Disinfection

(page 18).

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700001138880 Rev-AC

Summary of Contents for SurgiCount+

Page 1: ... or r U Us se e C Cr ra ad dlle e 0694 002 002 R Re ea ad de er r 0694 002 005 S St ta an nd d 0694 002 001 A Allt te er rn na at tiiv ve e C Cr ra ad dlle e M Mo ou un nt ts s 0694 002 003 0694 002 004 D Diis sp po os sa ab blle es s 0694 002 010 0694 002 006 EN 700001138880 Rev AC2021 02 ...

Page 2: ......

Page 3: ...ve Cradle Mounting Options 10 Getting Started 11 Before Use 11 Using Your Product 12 Charging the System 12 Interacting with the Cradle 12 Reader Instructions 13 Docking and Undocking the Reader 13 Replacing the Reader Battery 14 Preparing the Reader for Sterile Use 16 Interacting with the Stand 17 After Use 18 Cleaning and Disinfection 18 References 19 Inspection and Maintenance 19 Service 19 Tro...

Page 4: ...ys comply with this information to prevent patient and or healthcare staff injury C CA AU UT TI IO ON N Highlights a product reliability issue Always comply with this information to prevent product damage N No ot te e Supplements and or clarifies procedural information C Co on nt ta ac ct t I In nf fo or rm ma at tiio on n Stryker Representative 1 269 323 7700 1 800 253 3210 inst stryker cs stryke...

Page 5: ... R RE EF F SurgiCount Cradle Wall Mount 0694 002 003 SurgiCount Cradle Pole Mount 0694 002 004 D Diis sp po os sa ab blle es s R RE EF F SurgiCount Sponge Counting Bag QTY 250 0694 002 010 SurgiCount Reader Cover QTY 90 0694 002 006 N No ot te e For ordering information contact a Stryker sales representative D Do oc cu um me en nt ta at tiio on n This table identifies documentation associated with...

Page 6: ...iofrequency equipment and high frequency HF surgical equipment can affect the function of this medical electrical equipment see Electromagnetic Compatibility page 25 Always maintain a minimum separation distance of 6 inches 15 cm from an in use pacemaker and the UHF RFID antenna of the SurgiCount Reader while in use Failure to comply may cause interference with the pacemaker B Ba at tt te er ry y ...

Page 7: ...tem is MR unsafe Do not use the system in an MR environment A Ac cr ro on ny ym ms s A Ac cr ro on ny ym m D De ef fiin niit tiio on n CEC California Energy Commission EMC ElectroMagnetic Compatibility EPA Environmental Protection Agency FCC Federal Communications Commission HF High Frequency LAN Local Area Network LED Light Emitting Diode MR Magnetic Resonance PPE Personal Protection Equipment RF...

Page 8: ...ith the product L La ab be elliin ng g Fragile Magnetic Resonance MR Crossed Out Wheeled Bin Lithium Ion Universal Recycling Lithium Ion S Su ur rg giiC Co ou un nt t E Eq qu uiip pm me en nt t S Sy ym mb bo olls s a an nd d D De ef fiin niit tiio on ns s UHF RFID Antenna USB Type A Power Cord Hook Release Indicator EN 6 700001138880 Rev AC ...

Page 9: ...Cr ra ad dlle e M Mo ou un nt tiin ng g O Op pt tiio on ns s SurgiCount Stand recommended SurgiCount Wall Mount alternative SurgiCount Pole Mount alternative B A C F Fiig gu ur re e 1 1 C Cr ra ad dlle e F Fr ro on nt t V Viie ew w D F E F Fiig gu ur re e 2 2 C Cr ra ad dlle e R Re ea ar r V Viie ew w A A Tablet Dock D D Tilt Adjustment B B Insertion Removal Tab E E Power Cord Receptacle C C Reade...

Page 10: ...Re ea ad de er r F Fr ro on nt t V Viie ew w J I G H F Fiig gu ur re e 4 4 R Re ea ad de er r R Re ea ar r V Viie ew w A A Battery Cover F F USB Port manufacturer use only B B Battery Cover Release Buttons G G Charging Connection C C Barcode Scanner H H Operation Indicator D D UHF RFID Antenna I I Handle E E Trigger J J Speaker EN 8 700001138880 Rev AC ...

Page 11: ...for the SurgiCount System C D B A E F H I G J F Fiig gu ur re e 5 5 S St ta an nd d F Fr ro on nt t V Viie ew w A A Handle F F Arm hinged B B Cradle Mounting Location G G Power Cord Hook quick release C C Storage Tray sponge bags H H Power Cord D D Arm Hooks I I Stabilizing Base E E Storage Tray reader covers J J Swivel Casters x3 Locking Casters x2 700001138880 Rev AC 9 EN ...

Page 12: ... er rn na at tiiv ve e C Cr ra ad dlle e M Mo ou un nt tiin ng g O Op pt tiio on ns s F Fiig gu ur re e 6 6 W Wa allll M Mo ou un nt t F Fiig gu ur re e 7 7 P Po olle e M Mo ou un nt t EN 10 700001138880 Rev AC ...

Page 13: ...ation see Documentation page 3 4 Clean and disinfect the equipment before first use see Cleaning and Disinfection page 18 5 Verify the power cord is connected to an electrical power receptacle 6 Verify the tablet is ready for use Refer to the tablet instructions for use as needed see Documentation page 3 7 Dock the tablet see Interacting with the Cradle page 12 8 Remove the Reader Battery Cover pa...

Page 14: ... status and battery life can be viewed within the Surgical Tablet software application user interface For additional information refer to the instructions for use for the applicable Surgical Tablet software application 1 Verify the power cord is connected to an electrical power receptacle 2 Dock the tablet see Interacting with the Cradle page 12 3 Dock the Reader page 13 4 Verify the charging stat...

Page 15: ...de er r D Do oc ck k t th he e R Re ea ad de er r 1 Rotate the reader and grasp the front of the device 2 Insert the reader into the cradle Figure 10 U Un nd do oc ck k t th he e R Re ea ad de er r 1 Grasp the front of the reader 2 Pull the reader out of the cradle Figure 10 3 Rotate the reader and grasp the handle of the device F Fiig gu ur re e 1 10 0 D Do oc ck kiin ng g U Un nd do oc ck kiin n...

Page 16: ...er page 15 R Re em mo ov ve e t th he e R Re ea ad de er r B Ba at tt te er ry y C Co ov ve er r 1 Press and hold the battery cover release buttons Figure 11 2 Slide the cover back and remove Figure 12 F Fiig gu ur re e 1 11 1 P Pr re es ss s a an nd d H Ho olld d R Re elle ea as se e B Bu ut tt to on ns s F Fiig gu ur re e 1 12 2 R Re em mo ov ve e t th he e B Ba at tt te er ry y C Co ov ve er r ...

Page 17: ...a at tt te er ry y 1 Align and insert the battery tabs into the slots in the battery compartment Figure 15 2 Press down on the battery Figure 16 F Fiig gu ur re e 1 15 5 A Alliig gn n a an nd d I In ns se er rt t t th he e B Ba at tt te er ry y F Fiig gu ur re e 1 16 6 P Pr re es ss s D Do ow wn n o on n t th he e B Ba at tt te er ry y I In ns st ta allll t th he e R Re ea ad de er r B Ba at tt te...

Page 18: ...r 4 Scrub Technician Place hands inside the reader cover cuff to create an opening 5 Circulating Nurse Aseptically transfer the reader into the opening of reader cover 6 Scrub Technician After the reader is placed inside of the reader cover move hands to each end of the closure slide and allow the reader cover to fully extend 7 Scrub Technician Move the slider across to seal the reader cover F Fii...

Page 19: ...g ge e B Ba ag gs s F Fiig gu ur re e 2 20 0 L Lo oa ad diin ng g D Diis sp po os sa ab blle es s C CA AU UT TI IO ON N Always ensure the power cord is properly wrapped prior to transporting Always lock the casters when the stand is stationary and unlock prior to transporting F Fiig gu ur re e 2 21 1 L Lo oc ck kiin ng g t th he e C Ca as st te er rs s F Fiig gu ur re e 2 22 2 U Un nllo oc ck kiin...

Page 20: ...nt with a claim for activity against Hepatitis B The following disinfectants have been validated for use on the exterior surfaces of the equipment Quaternary Ammonium Based CaviCide EPA 46781 6 Clorox Healthcare Bleach Germicidal Wipes EPA Reg 67619 12 1 Wipe all external surfaces of the equipment with a soft lint free cloth moistened with a non abrasive hospital disinfectant prepared according to...

Page 21: ...r obstructions Equipment for corrosion discoloration pitting cracked materials or unacceptable deterioration on any external surfaces including on product labels Stand Configuration Inspect casters for damage and obstructions Stand Configuration Verify locking casters function properly If inspection criteria are not met or damage is apparent do not use the equipment and replace the damaged equipme...

Page 22: ...is present Reorient or relocate electrical equipment to maximize the spatial distance between the equipment Shielding the location may also be necessary Connect the system and other operating room equipment to different hospital grade electrical power receptacles on different branch circuits Turn off all electrical equipment not in use in the operating room Significant reduction in battery run tim...

Page 23: ...d Contact Stryker Cradle is damaged Contact Stryker Reader is continuously beeping while docked Reader battery is not installed or not installed properly Verify reader battery is properly installed see Replacing the Reader Battery page 14 Reader is damaged Contact Stryker Reader is not recognized by the tablet Reader is not fully docked Verify the reader is properly docked see Interacting with the...

Page 24: ... at tiio on ns s C Co om mm miis ss siio on n F FC CC C F FC CC C I ID D Q9R 0042 This device comples with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Changes or modifications not expressly approved by Stry...

Page 25: ... er ra all C Co om mm mu un niic ca at tiio on ns s C Co om mm miis ss siio on n F FC CC C F FC CC C I ID D UZ7RFD8500 This device comples with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Changes or modific...

Page 26: ...alled E En nv viir ro on nm me en nt ta all C Co on nd diit tiio on ns s E En nv viir ro on nm me en nt ta all C Co on nd diit tiio on n O Op pe er ra at tiio on n S St to or ra ag ge e a an nd d T Tr ra an ns sp po or rt t T Te em mp pe er ra at tu ur re e 10 30 20 50 R Re ella at tiiv ve e H Hu um miid diit ty y 75 20 90 10 A At tm mo os sp ph he er riic c P Pr re es ss su ur re e 106 106 50 EN ...

Page 27: ...r ro om ma ag gn ne et tiic c E En nv viir ro on nm me en nt t G Gu uiid da an nc ce e FCC Part 15 W WA AR RN NI IN NG G Always maintain a minimum separation distance of 9 inches 23 cm from the head and torso of a person and the UHF RFID antenna of the SurgiCount Reader while in use Failure to comply may cause FCC RF exposure limits to be exceeded The SurgiCount System complies with FCC regulation...

Page 28: ...quency for power supply lines 2 kV at 100 kHz repetition frequency for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5 1 kV line s to line s 0 5 1 2 kV line s to earth 0 5 1 kV line s to line s 0 5 1 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short...

Page 29: ...he following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz N No ot te e At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1Field strengths from fixed transmitters such as base...

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Page 32: ...for the following trademarks or service marks t th he e S St tr ry yk ke er r llo og go o All other trademarks are trademarks of their respective owners or holders M Ma an nu uf fa ac ct tu ur re ed d F Fo or r Stryker Instruments 1941 Stryker Way Portage Michigan 49002 USA 700001138880 Rev AC 2021 02 ...

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